As filed with the Securities and Exchange Commission on September 30, 2020
Registration No. 333-248487
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Amendment No. 1
to
FORM S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
SPRING BANK PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 52-2386345 | |
(State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
35 Parkwood Drive, Suite 210
Hopkinton, MA 01748
(508) 473-5993
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
Garrett Winslow, Esq.
General Counsel and Corporate Secretary
Spring Bank Pharmaceuticals, Inc.
35 Parkwood Drive, Suite 210
Hopkinton, MA 01748
(508) 473-5993
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Megan Gates, Esq. Melanie Ruthrauff Levy, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. One Financial Center Boston, MA 02111 (617) 542-6000 |
John D. Hogoboom, Esq. Lowenstein Sandler LLP 1251 Avenue of the Americas New York, New York 10020 (212) 262-6700 |
William Hicks, Esq. Matthew Tikonoff, Esq. Melissa Frayer, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. One Financial Center Boston, MA 02111 (617) 542-6000 |
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effectiveness of this registration statement and the satisfaction or waiver of all other conditions under the Exchange Agreement described herein.
If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, please check the following box. ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer, smaller reporting company and emerging growth company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer | ☐ | Accelerated filer | ☒ | |||
Non-accelerated filer | ☐ | Smaller reporting company | ☒ | |||
Emerging growth company | ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☒
If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:
Exchange Act Rule 13(e)-4(i) (Cross-Border Issuer Tender Offer) ☐
Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer) ☐
CALCULATION OF REGISTRATION FEE
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||||||||
Title of Each Class of Security to be Registered |
Amount
to be
|
Proposed Maximum Offering Price per Share |
Proposed Maximum Aggregate Offering Price(2) |
Amount of
Registration Fee(3) |
||||
Common stock, par value $0.0001 per share |
35,256,571 | N/A |
$279,676.19 |
$36.30 | ||||
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(1) |
Represents the maximum number of shares of common stock, $0.0001 par value per share (Spring Bank common stock), of Spring Bank Pharmaceuticals, Inc., a Delaware corporation (Spring Bank) to be registered based on the estimated maximum number of shares of Spring Bank common stock expected to be issued pursuant to that certain Share Exchange Agreement, dated as of July 29, 2020, by and among Spring Bank, F-star Therapeutics Limited, a private company registered in England and Wales (F-star) and the holders of issued and outstanding capital shares and convertible loan notes of F-star party thereto (the Exchange Agreement), in exchange for the entire issued and outstanding share capital of F-star (the Exchange) at an assumed exchange ratio of 0.5577 without giving effect to a reverse stock split of Spring Bank common stock expected to be completed immediately prior to closing of the Exchange. |
(2) |
Estimated solely for purposes of calculating the registration fee in accordance with Rule 457(f)(2) of the Securities Act of 1933, as amended. F-star is a private company, no market exists for its securities, and F-star has an accumulated capital deficit. Therefore, the proposed maximum aggregate offering price is one-third of the aggregate par value of the F-star securities expected to be exchanged in the transaction. This calculation takes into account a new investment in an assumed amount of $40.0 million in F-star, which is anticipated to occur following the date hereof and prior to the consummation of the Exchange. |
(3) |
This fee has been calculated pursuant to Section 6(b) of the Securities Act of 1933, as amended. Spring Bank previously paid this amount. |
The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information in this proxy statement/prospectus is not complete and may be changed. Spring Bank may not sell its securities pursuant to the proposed transactions until the Registration Statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
Subject to completion, dated September 30, 2020
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PROPOSED BUSINESS COMBINATION
YOUR VOTE IS VERY IMPORTANT
To the Stockholders of Spring Bank Pharmaceuticals, Inc.:
Spring Bank Pharmaceuticals, Inc. (Spring Bank), F-star Therapeutics Limited (F-star) and certain holders of issued and outstanding capital shares and convertible loan notes of F-star (each a Seller; collectively with holders of F-star securities who subsequently become parties to the Exchange Agreement, the Sellers) have entered into a share exchange agreement (the Exchange Agreement), pursuant to which Spring Bank will acquire the entire issued and outstanding share capital of F-star (the Exchange). The combined company, operating under the name F-star Therapeutics, Inc., will seek to advance F-stars immuno-oncology pipeline of multiple tetravalent bispecific antibody programs, as well as Spring Banks STING (STimulator of INterferon Gene) agonist, SB 11285, currently in a Phase 1a/1b clinical trial.
At the closing of the Exchange (the Closing), each ordinary share of F-star will be sold to Spring Bank in exchange for a number of shares of Spring Bank common stock based on the exchange ratio formula in the Exchange Agreement (the Exchange Ratio), rounded down to the nearest whole share of Spring Bank common stock after aggregating all fractional shares issuable to each Seller. The Exchange Ratio is subject to adjustment (i) to the extent that Spring Banks expected net cash as of Closing is less than $15.0 million or greater than $17.0 million, (ii) to the extent that F-star does not raise at least $25.0 million in the Pre-Closing Financing (as defined below) at a pre-money valuation, or the valuation of F-star prior to receiving any proceeds from the Pre-Closing Financing, of at least $35.0 million, and (iii) to account for the actual proceeds raised in the Pre-Closing Financing. Should the Closing occur after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. The assumed valuations and Exchange Ratio are likely to change, and the parties currently expect the Closing to occur during the fourth quarter of 2020. These and other potential adjustments to the Exchange Ratio are described further in the enclosed proxy statement/prospectus. Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the Spring Bank securityholders and the holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion (each as defined below) and Pre-Closing Financing) are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company.
Concurrently with the execution of the Exchange Agreement, certain existing investors of F-star, pursuant to binding equity commitment letters by and between each investor and F-star, agreed to purchase ordinary shares of F-star in a private placement to occur immediately prior to the Closing (the Pre-Closing Financing). F-star may continue to seek additional commitments in the Pre-Closing Financing until 11:59 p.m., Eastern time on the 10th day prior to the Special Meeting (as defined below).
F-stars issued share capital currently consists of ordinary shares, Seed Preference Shares and Series A Preference Shares. Immediately prior to the Closing, the Seed Preference Shares and Series A Preference Shares will be converted into F-star ordinary shares (the F-star Share Conversion). Additionally, pursuant to the terms of the Exchange Agreement and immediately prior to the Closing, all issued and outstanding F-star convertible loan notes will convert into F-star ordinary shares (the F-star Note Conversion).
All unvested issued and outstanding Spring Bank options and restricted stock units will be accelerated and vested in full immediately prior to the Closing and, following this acceleration, each option that has not previously been exercised will expire on the date of the Closing. All issued and outstanding F-star share options granted under F-stars legacy equity incentive plans will become exercisable in full immediately prior to the Closing. Upon the Closing, all holders of share options and restricted stock units granted by F-star under the
F-star Therapeutics Limited 2019 Equity Incentive Plan will have those awards replaced by options and awards, on the same terms (including vesting), for Spring Bank common stock, based on the Exchange Ratio.
Shares of Spring Bank common stock are currently listed on the Nasdaq Capital Market under the symbol SBPH. Spring Bank intends to file an initial listing application with the Nasdaq Capital Market pursuant to Nasdaqs rules for companies conducting a business combination that results in a change of control. Upon completion of the Exchange, Spring Bank will be renamed F-star Therapeutics, Inc. and expects its common stock to trade on the Nasdaq Capital Market under the symbol FSTX. On , 2020, the last trading day before the date of this proxy statement/prospectus, the closing sale price of Spring Bank common stock was $ per share. This closing sale price is not necessarily indicative of the price at which the common stock of the combined company will trade after the Closing.
Spring Bank is holding a special meeting of stockholders (the Special Meeting) via live audio webcast to seek the stockholder approvals necessary to complete the Exchange and related matters. You will be able to attend the virtual Special Meeting, vote and submit your questions during the Special Meeting by visiting www.virtualshareholdermeeting.com/SBPH2020SM. You will not be able to attend the virtual Special Meeting in person. At the Special Meeting, which will be held at , Eastern time, on , 2020, unless postponed or adjourned to a later date, Spring Bank will ask its stockholders to:
1. |
approve the issuance of Spring Bank common stock to the holders of F-star share capital in the Exchange, including holders who purchase ordinary shares of F-star in the Pre-Closing Financing, in accordance with the terms of Exchange Agreement, a copy of which is attached to this proxy statement/prospectus as Annex A, in an amount representing more than 20% of the shares of Spring Bank common stock outstanding immediately prior to the Exchange, which will also constitute stockholder approval of a change of control of Spring Bank, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively; |
2. |
approve an amendment to Spring Banks amended and restated certificate of incorporation effecting a reverse stock split of Spring Bank common stock at a ratio mutually agreed to between Spring Bank and F-star in the range of one new share for every shares to one new share for every shares outstanding (or any number in between); |
3. |
approve an amendment to Spring Banks amended and restated certificate of incorporation changing Spring Banks corporate name from Spring Bank Pharmaceuticals, Inc. to F-star Therapeutics, Inc. effective upon the Closing; |
4. |
approve a postponement or adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 or 3; and |
5. |
consider such other business as may properly come before the stockholders at the Special Meeting or any adjournment or postponement thereof. |
As described in the accompanying proxy statement/prospectus, each of the officers and directors and certain stockholders of Spring Bank, holding, in the aggregate, approximately 7.7% of the outstanding Spring Bank common stock as of September 15, 2020, have entered into voting agreements with F-star, whereby such stockholders have agreed to vote in favor of the proposals described above.
After careful consideration, the board of directors of Spring Bank has (i) determined that the Exchange is fair to, advisable and in the best interests of Spring Bank and its stockholders, and (ii) approved and declared advisable the Exchange Agreement and the transactions contemplated thereby. Spring Banks Board of Directors unanimously recommends that its stockholders vote FOR Proposal Nos. 1, 2, 3 and 4 described in this proxy statement/prospectus.
More information about Spring Bank, F-star and the Exchange is contained in this proxy statement/prospectus. We urge you to read this proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER THE SECTION TITLED RISK FACTORS IN THIS PROXY STATEMENT/PROSPECTUS.
We hope you will be able to attend the virtual Special Meeting. Even if you plan to attend the virtual Special Meeting, Spring Bank requests that you sign and return the enclosed proxy to ensure that your shares will be represented at the Special Meeting if you are unable to attend. You may also vote over the internet as well as by telephone or by mail.
We are excited about the opportunities the Exchange brings to both Spring Banks and F-stars respective stockholders, and thank you for your consideration and continued support.
Martin Driscoll |
Eliot Forster | |
President and Chief Executive Officer |
Chief Executive Officer | |
Spring Bank Pharmaceuticals, Inc. |
F-star Therapeutics Limited |
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this proxy statement/prospectus. Any representation to the contrary is a criminal offense.
This proxy statement/prospectus is dated , 2020, and is first being mailed to Spring Banks stockholders on or about , 2020.
SPRING BANK PHARMACEUTICALS, INC.
35 Parkwood Drive, Suite 210
Hopkinton, MA
(508) 473-5993
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
TO BE HELD ON
Dear Stockholders of Spring Bank Pharmaceuticals, Inc.:
On behalf of the board of directors (the Spring Bank Board) of Spring Bank Pharmaceuticals, Inc., a Delaware corporation (Spring Bank), we are pleased to deliver this proxy statement/prospectus for the proposed business combination between Spring Bank and F-star Therapeutics Limited, a private company registered in England and Wales (F-star), pursuant to which Spring Bank will acquire the entire issued and outstanding share capital of F-star (the Exchange). The Special Meeting of stockholders of Spring Bank (the Special Meeting) will be held via live audio webcast on the internet at www.virtualshareholdermeeting.com/SBPH2020SM on , 2020, at , Eastern time, for the following purposes:
1. |
To approve the issuance of Spring Bank common stock to the holders of F-star share capital in the Exchange, including holders who purchase ordinary shares of F-star in the Pre-Closing Financing (as defined in this proxy statement/prospectus) in accordance with the terms of a Share Exchange Agreement (the Exchange Agreement), a copy of which is attached to this proxy statement/prospectus as Annex A, in an amount representing more than 20% of the shares of Spring Bank common stock outstanding immediately prior to the Exchange, which shall also constitute stockholder approval of a change of control of Spring Bank, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively. |
2. |
To approve an amendment to Spring Banks amended and restated certificate of incorporation to effect a reverse split of all outstanding shares of the Spring Bank common stock at a reverse stock split ratio as mutually agreed to by Spring Bank and F-star in the range of one new share for every shares to one new share for every shares outstanding (or any number in between), in the form attached as Annex C to this proxy statement/prospectus. |
3. |
To approve an amendment to Spring Banks amended and restated certificate of incorporation to change the corporate name of Spring Bank from Spring Bank Pharmaceuticals, Inc. to F-star Therapeutics, Inc. effective upon the closing of the Exchange in the form attached as Annex D to this proxy statement/prospectus. |
4. |
To approve a postponement or adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 or 3. |
5. |
To transact such other business as may properly come before the stockholders at the Special Meeting or any adjournment or postponement thereof. |
The Spring Bank Board has fixed , 2020, as the record date (the Record Date) for the determination of stockholders entitled to notice of, and to vote at, the Special Meeting and any postponement or adjournment thereof. Only holders of record of shares of Spring Banks common stock at the close of business on the Record Date are entitled to notice of, and to vote at, the Special Meeting. At the close of business on the Record Date, there were shares of Spring Banks common stock outstanding and entitled to vote.
Your vote is important. The affirmative vote of a majority of the voting power of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter is required for approval of Proposal Nos. 1 and 4. The affirmative vote of the holders of a majority of shares of Spring Banks common stock having voting power outstanding on the Record Date for the Special Meeting is required for approval of Proposal Nos. 2 and 3. The approval of Proposal Nos. 1, 2 and 3 is a condition of the Exchange Agreement. Therefore, the Exchange cannot be consummated without the approval of Proposal Nos. 1, 2 and 3. Proposal No. 3 is conditioned upon the consummation of the Exchange Agreement. If the Exchange is not completed, Proposal No. 3 will not be implemented, and Spring Banks name will not be changed. Even if you plan to attend the virtual Special Meeting, Spring Bank requests that you sign and return the enclosed proxy to ensure that your shares will be represented at the Special Meeting if you are unable to attend. You may also vote over the internet as well as by telephone or by mail.
By Order of Spring Banks Board of Directors,
Martin Driscoll
Spring Bank Pharmaceuticals, Inc.
Hopkinton, Massachusetts
, 2020
THE SPRING BANK BOARD HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, SPRING BANK AND ITS STOCKHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. THE SPRING BANK BOARD UNANIMOUSLY RECOMMENDS THAT SPRING BANK STOCKHOLDERS VOTE FOR EACH SUCH PROPOSAL.
REFERENCES TO ADDITIONAL INFORMATION
This proxy statement/prospectus incorporates important business and financial information about Spring Bank that is not included in or delivered with this document. You may obtain this information without charge through the Securities and Exchange Commission (SEC) website (www.sec.gov) or upon your written or oral request by contacting Spring Banks Corporate Secretary at Spring Bank Pharmaceuticals, Inc., 35 Parkwood Drive, Suite 210, Hopkinton, MA 01748 or by calling (508) 473-5993.
You may also request additional copies from Spring Banks proxy solicitor using the following contact information:
The Proxy Advisory Group, LLC
18 East 41st Street, Suite 2000
New York, New York 10017
1-212-616-2181
To ensure timely delivery of these documents, any request should be made no later than , 2020, to receive them before the Special Meeting of Spring Bank stockholders.
For additional details about where you can find information about Spring Bank, see the section titled Where You Can Find More Information in this proxy statement/prospectus.
i
QUESTIONS AND ANSWERS ABOUT THE EXCHANGE
Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus does not give effect to the proposed reverse stock split described in Proposal No. 2 of this proxy statement/prospectus.
The following section provides answers to frequently asked questions about the Exchange (as defined below). This section, however, provides only summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections.
Q: |
What is the Exchange? |
A: |
On July 29, 2020, Spring Bank Pharmaceuticals, Inc. (Spring Bank), F-star Therapeutics Limited (F-star) and certain holders of issued and outstanding capital shares and convertible loan notes of F-star (each a Seller; collectively with holders of F-star securities who subsequently become parties thereto, the Sellers) entered into a share exchange agreement (the Exchange Agreement). The Exchange Agreement contains the terms and conditions of the proposed business combination of Spring Bank and F-star. Under the Exchange Agreement, Spring Bank will acquire the entire issued and outstanding share capital of F-star (including all shares issuable in connection with the F-star Note Conversion, Pre-Closing Financing and F-star Share Conversion (in each case, as defined below)) (the Exchange). |
F-stars issued share capital currently consists of ordinary shares, Seed Preference Shares and Series A Preference Shares. Immediately prior to the closing of the Exchange (the Closing), the Seed Preference Shares and Series A Preference Shares will be converted into F-star ordinary shares (the F-star Share Conversion). Additionally, pursuant to the terms of the Exchange Agreement and immediately prior to the Closing, all issued and outstanding F-star convertible loan notes will convert into F-star ordinary shares (the F-star Note Conversion).
At the Closing, each ordinary share of F-star will be sold to Spring Bank in exchange for a number of shares of Spring Bank common stock, based on the exchange ratio formula in the Exchange Agreement (the Exchange Ratio), rounded down to the nearest whole share of Spring Bank common stock after aggregating all fractional shares issuable to each Seller on a holder by holder basis.
Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation, or the valuation of F-star prior to receiving any proceeds from the Pre-Closing Financing, of at least $35.0 million), the Spring Bank securityholders and holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion and Pre-Closing Financing) are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company.
The Exchange Ratio is subject to adjustment and the respective ownership percentages for F-star and Spring Bank stockholders will change (i) to the extent that Spring Banks expected net cash as of Closing is less than $15.0 million or greater than $17.0 million, (ii) to the extent that F-star does not raise at least $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million, and (iii) to account for the actual proceeds raised in the Pre-Closing Financing. Should the Closing occur after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. The assumed valuations and Exchange Ratio are likely to change, and the parties currently expect the Closing to occur during the fourth quarter of 2020. These and other adjustments to the Exchange Ratio are described further in this prospectus/proxy statement.
Effective as of the Closing, and assuming Spring Banks Stockholders approve Proposal No. 3, Spring Bank will change its corporate name to F-star Therapeutics, Inc. as required by the Exchange Agreement.
Q: |
What will happen to Spring Bank if, for any reason, the Exchange does not close? |
A: |
If, for any reason, the Exchange does not close, the board of directors of Spring Bank (the Spring Bank Board) may elect to, among other things, continue to operate the business of Spring Bank, attempt to complete another strategic transaction like the Exchange, sell or otherwise dispose of the various assets of |
Spring Bank or dissolve or liquidate the company. If the Spring Bank Board decides to dissolve and liquidate Spring Banks assets, Spring Bank would be required to wind down its clinical trials, pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims. This would be a lengthy and uncertain process, and there can be no assurances as to the amount or timing of available cash, if any, that would be left to distribute to Spring Bank stockholders after paying the debts and other obligations of Spring Bank and setting aside funds for reserves. |
Q: |
Why are the two companies proposing to combine? |
A: |
F-star and Spring Bank believe that the Exchange will result in a publicly listed company seeking to advance F-stars clinical and preclinical immuno-oncology pipeline of multiple tetravalent bispecific antibody programs, as well as Spring Banks STING (STimulator of INterferon Gene) agonist, SB 11285, currently in a Phase 1a/1b clinical trial. For a discussion of Spring Banks and F-stars reasons for the Exchange, see the section titled The ExchangeSpring Bank Reasons for the Exchange and The ExchangeF-star Reasons for the Exchange in this proxy statement/prospectus. |
Q: |
Why am I receiving this proxy statement/prospectus? |
A: |
You are receiving this proxy statement/prospectus because you have been identified as a Spring Bank stockholder as of the Record Date (as defined below), and you are entitled to vote at the Special Meeting to approve the transactions contemplated by the Exchange Agreement, including the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement. This document serves as: |
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a proxy statement of Spring Bank used to solicit proxies for the Special Meeting; and |
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a prospectus of Spring Bank used to offer shares of Spring Bank common stock in exchange for F-star share capital in the Exchange to F-star securityholders. |
Q: |
What is required to consummate the Exchange? |
A: |
To consummate the Exchange, Spring Bank stockholders must approve the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement (Proposal No. 1), approve and adopt the amendment to the amended and restated certificate of incorporation of Spring Bank effecting a reverse stock split at a ratio as mutually agreed to by Spring Bank and F-star in the range of one new share for every shares to one new share for every shares outstanding (the Reverse Stock Split) (Proposal No. 2) and approve and adopt an amendment to the amended and restated certificate of incorporation of Spring Bank to change the corporate name of Spring Bank from Spring Bank Pharmaceuticals, Inc. to F-star Therapeutics, Inc. effective as of the Closing (the Spring Bank Name Change) (Proposal No. 3). |
The approval of the issuance of Spring Bank common stock pursuant to the Exchange Agreement (Proposal No. 1) by the Spring Bank stockholders requires the affirmative vote of a majority of the voting power of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter. The approval of the amendments to the amended and restated certificate of incorporation of Spring Bank to effect the Reverse Stock Split (Proposal No. 2) and the Spring Bank Name Change (Proposal No. 3) require the affirmative vote of the holders of a majority of shares of Spring Bank common stock having voting power outstanding on , 2020 (the Record Date). The approval of the Reverse Stock Split (Proposal No. 2) and Spring Bank Name Change (Proposal No. 3) is a condition to closing under the Exchange Agreement. Consequently, if the requisite Spring Bank stockholders approve the Exchange and the issuance of Spring Bank common stock pursuant to the Exchange Agreement but do not approve the Reverse Stock Split or the Spring Bank Name Change, the Exchange will not be consummated.
The Spring Bank Name Change (Proposal No. 3) is a condition to Closing under the Exchange Agreement. If the Exchange is not completed, Proposal No. 3 will not be implemented, and Spring Banks name will not be changed. The Reverse Stock Split (Proposal No. 2) is not conditioned upon the consummation of the Exchange, and the Reverse Stock Split may be implemented by the Spring Bank Board even if the Exchange does not take place.
The presence at the Special Meeting of the holders of a majority in voting power of all outstanding shares of Spring Bank common stock entitled to vote at the Special Meeting is necessary to constitute a quorum at the
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meeting. Votes of stockholders of record who are represented at the Special Meeting abstentions, and broker non-votes are counted for purposes of determining whether a quorum exists.
Votes will be counted by the inspector of election appointed for the Special Meeting, who will separately count FOR and AGAINST votes, abstentions and broker non-votes. Abstentions and broker non-votes will not be considered votes cast by the holders of all the shares of Spring Bank common stock represented at the Special Meeting and voting affirmatively or negatively, and will therefore not have any effect with respect to Proposal No. 1. Abstentions will have the same effect as a vote AGAINST Proposal Nos. 2 and 3. Abstentions will not have any effect with respect to Proposal No. 4.
As of September 15, 2020, certain Spring Bank stockholders who in the aggregate own approximately 7.7% of the outstanding shares of Spring Bank common stock, have entered into Voting Agreements (as defined below) with Spring Bank and F-star, whereby such stockholders have agreed to vote their shares in favor of the Proposals described above.
For a more complete description of the closing conditions under the Exchange Agreement, Spring Bank urges you to read the section titled The Exchange AgreementConditions to the Completion of the Exchange in this proxy statement/prospectus.
Q: |
What will F-star Securityholders receive in the Exchange? |
A: |
Immediately after the consummation of the Exchange, the holders of F-star share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion and Pre-Closing Financing) will receive shares of Spring Bank common stock equal to the Exchange Ratio for each F-star ordinary share held immediately prior to the Closing. Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the F-star securityholders are expected to own approximately 61.2% of the outstanding capital stock of the combined company, which is subject to adjustment as described in the section titled The Exchange Agreement Transaction Consideration and Adjustment. |
All issued and outstanding F-star share options granted under its three legacy equity incentive plans are currently exercisable, and prior to the Closing, the holders of F-star Legacy Options will be notified by the F-star Board of Directors that they may exercise their F-star Legacy Options conditional upon and effective at the Closing. All holders of share options and restricted stock units granted by F-star under the F-star 2019 Equity Incentive Plan will have those awards replaced by options and awards on the same terms (including vesting) for Spring Bank common stock, based on the Exchange Ratio.
For a more complete description of what holders of F-star share capital will receive in the Exchange, see the section titled The Exchange AgreementExchange Consideration in this proxy statement/prospectus.
Q: |
What will Spring Bank stockholders receive in the Exchange? |
A: |
At the Closing, Spring Bank stockholders will continue to own and hold their existing shares of Spring Bank common stock. Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the Spring Bank securityholders are expected to own approximately 38.8% of the outstanding capital stock of the combined company, which is subject to adjustment as described in the section titled The Exchange AgreementTransaction Consideration and Adjustment. |
All unvested issued and outstanding Spring Bank options and restricted stock units will be accelerated and vested in full immediately prior to the Closing and, following this acceleration, each option that has not previously been exercised will expire on the date of the Closing.
In addition, Spring Bank stockholders will receive two separate and distinct contingent value rights (CVRs) for each share of Spring Bank common stock held of record as of immediately prior to the Closing. The CVRs will represent the rights to receive cash payments in connection with (i) certain
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transactions involving Spring Banks proprietary STING agonist compound (the STING Agonist CVR Agreement) and (ii) certain other transactions involving Spring Banks proprietary STING antagonist compound (the STING Antagonist CVR Agreement).
Pursuant to the Exchange Agreement and the STING Agonist CVR Agreement, each share of Spring Bank common stock held by Spring Bank stockholders as of a record date immediately prior to the Closing will receive a dividend of one CVR entitling such holders to receive, in connection with certain transactions involving Spring Banks proprietary STimulator of INterferon Genes (STING) agonist compound occurring on or prior to an agreed-upon expiration date, an aggregate amount equal to the greater of (i) 25% of the Net Proceeds received from all STING Agonist CVR Transactions (each as defined in the STING Agonist CVR Agreement) and (ii) up to an aggregate amount of $18.0 million, the product of $1.00 (as adjusted for the Reverse Stock Split, to the extent applicable) and the total number of shares of Spring Bank common stock outstanding as of such record date.
Pursuant to the Exchange Agreement and the STING Antagonist CVR Agreement, each share of Spring Bank common stock held by Spring Bank stockholders as of a record date immediately prior to the Closing will receive a dividend of one CVR entitling such holders to receive, in connection with the execution of a potential development agreement (the Approved Development Agreement) and certain other transactions involving Spring Banks proprietary STING antagonist compound occurring during the seven-year period after the Closing, an amount equal to 80% of all Net Proceeds (each as defined in the STING Antagonist CVR Agreement) received by Spring Bank after the Closing pursuant to (i) the Approved Development Agreement, if any, and (ii) all STING Antagonist CVR Transactions (as defined in the STING Antagonist CVR Agreement) entered into during the seven-year period after the Closing.
See the section titled Agreements Related to the ExchangeContingent Value Rights Agreements in this proxy statement/prospectus.
Q: |
Who will be the directors of the combined company following the Exchange? |
A: |
Following the Closing, the board of directors of the combined company will include a total of eight directors, three of whom will be current directors of Spring Bank and five of whom will be designated by F-star. It is anticipated that, following the Closing, the board of directors of the combined company will be constituted as follows: |
Name |
Current Principal Affiliation |
|
Eliot Forster, Ph.D. | Director and Chief Executive Officer, F-star | |
Nessan Bermingham, Ph.D. | Director, F-star | |
Edward Benz, Jr., M.D. | Director, F-star | |
Geoffrey Race | Director, F-star | |
Patrick Krol | Director, F-star | |
David Arkowitz | Director, Spring Bank | |
Todd Brady, M.D., Ph.D. | Director, Spring Bank | |
Pamela Klein, M.D. | Director, Spring Bank |
Q: |
Who will be the executive officers of the combined company immediately following the Exchange? |
A: |
Immediately following the Closing, the executive management team of the combined company is expected to be as follows: |
Name |
Title |
|
Eliot Forster, Ph.D. | President, Chief Executive Officer and Director | |
Darlene Deptula-Hicks | Chief Financial Officer and Treasurer | |
Neil Brewis, Ph.D. | Chief Scientific Officer | |
Louis Kayitalire, M.D. | Chief Medical Officer |
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Q: |
What are the material U.S. federal income tax consequences of the Exchange to U.S. Holders? |
A: |
Spring Bank and F-star intend to treat the Exchange as constituting a reorganization within the meaning of Section 368(a)(1)(B) of the Internal Revenue Code of 1986, as amended (a B-Reorganization). As further described in the section titled The ExchangeMaterial U.S. Federal Income Tax Consequences of the Exchange to U.S. Holders in this proxy statement/prospectus, whether the Exchange constitutes a B-Reorganization is uncertain. Assuming the Exchange constitutes a B-Reorganization, subject to the limitations and qualifications further described in the above referenced section of this proxy statement/prospectus, U.S. Holders (as defined in the above referenced section of this proxy statement/prospectus) of F-star shares generally should not recognize gain or loss for U.S. federal income tax purposes in connection with the Exchange. |
If the Exchange is not treated as a B-Reorganization, then, subject to the limitations and qualifications described in the above referenced section of this proxy statement/prospectus, each U.S. Holder of F-star share capital will generally recognize capital gain or loss, for U.S. federal income tax purposes, on the receipt of shares of Spring Bank common stock issued to such U.S. Holder in the Exchange. The U.S. federal income tax consequences to each U.S. Holder of F-star share capital will depend on that stockholders particular circumstances. Each U.S. Holder of F-star share capital should consult with his, her or its tax advisor for a full understanding of the tax consequences of the Exchange to that stockholder.
There are no material U.S. federal income tax consequences of the Exchange to U.S. Holders of Spring Bank common stock.
Q: |
What are the material U.S. federal income tax consequences of the receipt of two CVRs and the Reverse Stock Split to U.S. Holders? |
A: |
Spring Bank intends to take the position that the fair market value of the CVRs cannot be reasonably ascertained on the date of the issuance of the CVRs and, accordingly, the issuance of the CVRs constitutes an open transaction. Accordingly, absent a change in law requiring otherwise, Spring Bank will not report the issuance of the CVRs as a current distribution of property with respect to its stock and will instead report each future cash payment (if any) on the CVRs as a distribution by Spring Bank for U.S. federal income tax purposes, with each such payment being reported as a dividend to the extent of Spring Banks current or accumulated earnings and profits in the year in which such payment is made. However, as further described in the in the section titled Agreements Related to the Share ExchangeMaterial U.S. Federal Income Tax Consequences of the Receipt of CVRs to U.S. Holders in this proxy statement/prospectus, there is substantial uncertainty as to the U.S. federal income tax treatment of the issuance of CVRs. Specifically, there is no authority directly addressing whether the issuance of contingent value rights with characteristics similar to the CVRs should be treated as a distribution of property with respect to the Spring Banks common stock, a distribution of equity, a debt instrument or an open transaction for U.S. federal income tax purposes. Applicable U.S. Treasury regulations provide that open transaction treatment is only available in those rare and extraordinary cases involving contingent payment obligations in which the fair market value of the obligation cannot reasonably be ascertained. If the issuance of the CVRs is treated as an open transaction, a U.S. Holder (as defined in the above referenced section of this proxy statement/prospectus) would not generally recognize income in respect of the CVRs at the time such CVRs are issued and would take no tax basis in the CVRs. Future cash payments (if any) on the CVRs would be treated as a distribution and constitute a dividend to the extent of the U.S. Holders pro rata share of Spring Bank current or accumulated earnings and profits (as determined for U.S. federal income tax purposes) in the taxable year of such payment, then as a non-taxable return of capital to the extent of the U.S. Holders basis in its Spring Bank common stock, and finally as capital gain from the sale or exchange of Spring Bank common stock with respect to any remaining payment. Dividends received by individual U.S. Holders are currently eligible for reduced rates of taxation applicable to long-term capital gains, provided certain holding period requirements are met. |
Spring Bank intends to treat the Reverse Stock Split and the issuance of CVRs as separate transactions for U.S. federal income tax purposes. However, as provided in more detail in the section titled Matters Being Submitted to a Vote of Spring Bank StockholdersProposal No. 2: Approval of an amendment to the
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Amended and Restated Certificate of Incorporation of Spring Bank Effecting the Reverse Stock SplitMaterial U.S. Federal Income Tax Consequences of the Reverse Stock Split to U.S. Holders whether the Reverse Stock Split and the issuance of CVRs should be treated as separate transactions or as a single transactions is uncertain. Consistent with Spring Banks intent to treat the Reverse Stock Split and the issuance of CVRs as separate transactions for U.S. federal income tax purposes, a U.S. Holder of Spring Bank common stock generally should not recognize gain or loss upon the Reverse Stock Split, except to the extent a U.S. Holder receives cash in lieu of a fractional share of Spring Bank common stock. Please review the information in the above referenced section of this proxy statement/prospectus for a more complete description of the material U.S. federal income tax consequences of the Reverse Stock Split to U.S. Holders of Spring Bank common stock.
The tax consequences to you of the receipt of CVRs and the Reverse Stock Split are subject to substantial uncertainty and may also depend on your particular facts and circumstances. Please consult your tax advisors as to the specific tax consequences to you.
Q: |
What is the Pre-Closing Financing? |
A: |
Concurrently with entering into the Exchange Agreement, certain existing investors of F-star agreed, pursuant to binding equity commitment letters by and between each investor and F-star, to purchase ordinary shares of F-star in a private placement to occur immediately prior to the Closing. This is referred to as the Pre-Closing Financing. As of , 2020, F-star had received commitments from investors to purchase $ million of ordinary shares of F-star in the Pre-Closing Financing. F-star may continue to seek additional commitments in the Pre-Closing Financing until 11:59 p.m., Eastern time on the 10th day prior to the Special Meeting. The Pre-Closing Financing is expected to be completed pursuant to Regulation D under the Securities Act of 1933, as amended. F-star ordinary shares that are issued in the Pre-Closing Financing will be converted into shares of Spring Bank common stock in the Exchange. Accordingly, by approving Proposal No. 1 relating to the issuance of shares in the Exchange, Spring Bank stockholders will also be approving the issuance of shares of Spring Bank common stock to be issued in exchange for all F-star ordinary shares that are sold in the Pre-Closing Financing. |
Q: |
Do persons involved in the Exchange have interests that may conflict with mine as a Spring Bank stockholder? |
A: |
Yes. When considering the recommendation of the Spring Bank Board, you should be aware that certain Spring Bank directors and executive officers have interests in the Exchange that are different from, or are in addition to, yours. The Spring Bank Board was aware of these interests and considered them, among other matters, in its decision to approve the Exchange. Upon completion of the Exchange, if the employment of Martin Driscoll, R. P. Kris Iyer, Ph.D., Lori Firmani and Garrett Winslow, is terminated by Spring Bank without cause, these executive officers will be entitled to certain payments and employment benefits following their respective terminations. In addition, all unvested issued and outstanding Spring Bank options and restricted stock units will be accelerated and vested in full immediately prior to the Closing and, following this acceleration, each option that has not previously been exercised will expire on the date of the Closing. As of September 15, 2020, the aggregate value of these severance payments, benefits and accelerated vesting is $2,163,998 (collectively, not individually), as described in the section titled The ExchangeInterests of the Spring Bank Directors and Executive Officers in the ExchangeExchange-Related Compensation of Executive Officers in this proxy statement/prospectus. Additionally, David Arkowitz, Todd Brady, M.D., Ph.D. and Pamela Klein, M.D., current members of the Spring Bank Board, will continue to serve as members of the combined companys board of directors after the Exchange. |
Q: |
As a Spring Bank stockholder, how does the Spring Bank Board recommend that I vote? |
A: |
After careful consideration, the Spring Bank Board unanimously recommends that Spring Bank stockholders vote FOR each of the proposals. |
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Q: |
What risks should I consider in deciding whether to vote in favor of the Exchange? |
A: |
You should carefully review the section of this proxy statement/prospectus titled Risk Factors, which sets forth certain risks and uncertainties related to the Exchange, risks and uncertainties to which the combined companys business will be subject, and risks and uncertainties to which each of Spring Bank and F-star, as independent companies, are subject. |
Q: |
Who can vote at the Special Meeting? |
A: |
Only Spring Bank stockholders of record at the close of business on the Record Date, , 2020, will be entitled to vote at the Special Meeting. As of , 2020, there were shares of Spring Bank common stock outstanding and entitled to vote. |
Stockholder of Record: Shares Registered in Your Name
If, at the close of business on the Record Date, your shares of Spring Bank common stock were registered directly in your name with Spring Banks transfer agent, Computershare Trust Company, N.A., then you are a Spring Bank stockholder of record. As a Spring Bank stockholder of record, you may vote at the Special Meeting or vote by proxy. Whether or not you plan to attend the Special Meeting, please vote as soon as possible by completing and returning the enclosed proxy card or vote by proxy over the telephone or on the internet as instructed below to ensure your vote is counted.
Beneficial Owner: Shares Registered in the Name of a Broker or Bank
If, at the close of business on the Record Date, your shares of Spring Bank common stock were not held in your name, but rather in an account at a brokerage firm, bank, dealer or other similar organization, then you are the beneficial owner of shares held in street name and these proxy materials are being forwarded to you by that organization. The organization holding your account is considered to be the stockholder of record for purposes of voting at the Special Meeting. As a beneficial owner, you have the right to direct your broker or other agent how to vote the shares in your account. You are also invited to attend the Special Meeting and may vote at the Special Meeting or vote by proxy. If your shares are not registered in your own name and you plan to vote your shares in person at the virtual Special Meeting, you will need the 16-digit control number included with your proxy materials or provided by the brokerage firm, bank, dealer or other similar organization that holds your shares.
Q: |
As a holder of Spring Bank common stock, how many votes do I have? |
A: |
On each matter to be voted upon, you have one vote for each share of Spring Bank common stock you own as of the Record Date. |
Q: |
What is the quorum requirement for the Special Meeting? |
A: |
The presence, of the holders of a majority of the voting power of all outstanding shares of Spring Bank common stock entitled to vote at the Special Meeting is necessary to constitute a quorum at the Special Meeting. Votes of stockholders of record who are represented at the Special Meeting abstentions, and broker non-votes are counted for purposes of determining whether a quorum exists. |
On , 2020, there were shares of Spring Bank common stock outstanding and entitled to vote. Accordingly, Spring Bank expects that the holders of at least shares of Spring Bank common stock must be present at the Special Meeting for a quorum to exist.
Q: |
What are broker non-votes? |
A: |
If you hold shares beneficially in street name and do not provide your broker or other agent with voting instructions, your shares may constitute broker non-votes. Broker non-votes occur on a matter when banks, brokers and other nominees are not permitted to vote on certain non-discretionary matters without instructions from the beneficial owner and instructions are not given. These matters are referred to as non-routine matters. Proposal No. 1 is anticipated to be a non-routine matter, and Proposal Nos. 2, 3 and 4 |
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are anticipated to be routine matters on which Spring Bank expects brokers, banks or other nominees to have authority and, therefore, broker non-votes are not expected with respect to these proposals. Broker non-votes will have no effect on the outcome of Proposal No. 1. |
Q: |
When do you expect the Exchange to be consummated? |
A: |
Spring Bank and F-star anticipate that the closing of the Exchange will occur in the fourth quarter of 2020, shortly after the Special Meeting to be held on , 2020, but the companies cannot predict the exact timing. For more information, see the section titled The Exchange AgreementConditions to the Completion of the Exchange in this proxy statement/prospectus. |
Q: |
What do I need to do now? |
A: |
Spring Bank and F-star urge you to read this proxy statement/prospectus carefully, including its annexes, and to consider how the Exchange affects you. |
If you are a Spring Bank stockholder of record, you may provide your proxy instructions in one of two different ways. First, you can mail your signed proxy card in the enclosed return envelope. You may also provide your proxy instructions via telephone or via the internet by following the instructions on your proxy card or voting instruction form. Please provide your proxy instructions only once, unless you are revoking a previously delivered proxy instruction, and as soon as possible so that your shares can be voted at the Special Meeting.
Q: |
What happens if I do not return a proxy card or otherwise provide proxy instructions, as applicable? |
A: |
If you are a Spring Bank stockholder, the failure to return your proxy card or otherwise provide proxy instructions will reduce the aggregate number of votes required to approve Proposal Nos. 1 and 4 and will have the same effect as a vote AGAINST Proposal Nos. 2 and 3. |
Q: |
When and where is the Special Meeting of Spring Bank stockholders? |
A: |
The Special Meeting will be held virtually via live audio webcast on the internet at www.virtualshareholdermeeting.com/SBPH2020SM at , Eastern time, on , 2020. |
Q: |
If my Spring Bank shares are held in street name by my broker, will my broker vote my shares for me? |
A: |
Unless your broker has discretionary authority to vote on certain matters, your broker will not be able to vote your shares of Spring Bank common stock without instructions from you. Brokers are not expected to have discretionary authority to vote for Proposal No. 1. To make sure that your vote is counted, you should instruct your broker to vote your shares, following the procedures provided by your broker. |
Q: |
May I change my vote after I have submitted a proxy or provided proxy instructions? |
A: |
Spring Bank stockholders of record, other than those Spring Bank stockholders who are parties to the Voting Agreements, may change their vote at any time before their proxy is voted at the Special Meeting in one of four ways. First, a Spring Bank stockholder of record can send a written notice to the Secretary of Spring Bank stating that it would like to revoke its proxy. Second, a Spring Bank stockholder of record can submit new proxy instructions either on a new proxy card, via telephone or via the internet. Third, a Spring Bank stockholder of record can attend the Special Meeting and vote. Attendance alone will not revoke a proxy. If a Spring Bank stockholder who owns shares of Spring Bank common stock in street name has instructed a broker to vote its shares of Spring Bank common stock, the stockholder must follow directions received from its broker to change those instructions. The Spring Bank stockholders most current vote, whether by telephone, internet or proxy card, is the one that will be counted. |
Q: |
Who is paying for this proxy solicitation? |
A: |
Spring Bank and F-star will share equally, up to $50,000 in the case of F-star, the cost of soliciting, printing and filing this proxy statement/prospectus and the proxy card. Arrangements will also be made with |
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brokerage firms and other custodians, nominees and fiduciaries who are record holders of Spring Bank common stock for the forwarding of solicitation materials to the beneficial owners of Spring Bank common stock. Spring Bank will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials. |
Spring Bank has engaged The Proxy Advisory Group, LLC to assist in the solicitation of proxies and provide related advice and informational support, for a services fee and the reimbursement of customary disbursements that are not expected to exceed $25,000 in total.
Q: |
Who can help answer my questions? |
A: |
If you are a Spring Bank stockholder and would like additional copies, without charge, of this proxy statement/prospectus or if you have questions about the Exchange, including the procedures for voting your shares, you should contact: |
Spring Bank Pharmaceuticals, Inc.
35 Parkwood Drive, Suite 210
Hopkinton, MA
(508) 473-5993
Attn: General Counsel and Corporate Secretary
You may also request information from The Proxy Advisory Group, LLC, Spring Banks proxy solicitor, at the following address and telephone number:
The Proxy Advisory Group, LLC
18 East 41st Street, Suite 2000
New York, New York 10017
1-212-616-2181
If you are a holder of F-star share capital, and would like additional copies, without charge, of this proxy statement/prospectus or if you have questions about the Exchange, you should contact:
F-star Therapeutics Limited
Eddeva B920
Babraham Research Campus
Cambridge, CB22 3AT
United Kingdom
+44-1223 497400
Attn: General Counsel
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This summary highlights selected information from this proxy statement/prospectus and may not contain all of the information that is important to you. To better understand the Exchange and the proposals being considered at the Special Meeting, you should read this entire proxy statement/prospectus carefully, including the Exchange Agreement attached as Annex A, the opinion of Ladenburg Thalmann & Co. Inc. (Ladenburg) attached as Annex B and the other annexes to which you are referred herein. For more information, see the section titled Where You Can Find More Information in this proxy statement/prospectus.
The Companies
Spring Bank Pharmaceuticals, Inc.
Spring Bank Pharmaceuticals, Inc.
35 Parkwood Drive, Suite 210
Hopkinton, MA 01748
(508) 473-5993
Spring Bank is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of a range of cancers and inflammatory diseases using its proprietary small molecule nucleotide platform. Spring Bank designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. Its internally developed programs are primarily designed to stimulate and/or dampen immune responses. Spring Bank is devoting its resources to advancing multiple programs in its STING product portfolio, including its STING agonist clinical program for intravenously-administered SB 11285 in oncology, its STING antagonist compounds for inflammatory diseases, and its STING agonist antibody drug conjugate program for oncology. On July 29, 2020, Spring Bank announced that it had entered into a definitive agreement with F-star and certain holders of issued and outstanding capital shares and convertible loan notes of F-star, under which Spring Bank will acquire the entire issued and outstanding share capital of F-star.
F-star Therapeutics Limited
F-star Therapeutics Limited
Eddeva B920
Babraham Research Campus
Cambridge, CB22 3AT
United Kingdom
+44-1223 497400
F-star is a clinical-stage immuno-oncology company focused on transforming the lives of patients with cancer through the development of F-stars innovative tetravalent mAb2 bispecific antibodies. With four distinct binding sites in a natural human antibody format, F-star believes its proprietary technology will overcome many of the challenges facing current immuno-oncology therapies, because of the strong pharmacology enabled by tetravalent bispecific binding. F-stars vision is to transform the treatment of cancer through the development of differentiated and well-tolerated mAb2 bispecific antibodies, which are designed to address multiple immune evasion pathways that limit the effect of current immuno-oncology therapies.
F-stars most advanced product candidate, FS118, simultaneously targets two immune checkpoint receptors, LAG-3 and PD-L1, to directly address known tumor evasion pathways, and is currently being evaluated in a Phase 1 trial in heavily pretreated patients with advanced cancer, having received a median of six lines of such treatments. F-star expects to report data from this Phase 1 trial in the fourth quarter of 2020, and to initiate a proof of concept trial in PD-1/PD-L1 resistant patients in selected indications in the first half of 2021. For another of its mAb2 product candidates, FS120, which targets CD137 and OX40, F-star has an open Investigational New Drug application (IND), from the U.S. Food and Drug Administration (FDA), and plans
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to initiate a Phase 1 trial in patients with advanced cancers in the fourth quarter of 2020. F-star intends to submit a Clinical Trial Application (CTA), to the European Medicines Agency (EMA) for an additional mAb2 product candidate, FS222, which targets PD-L1 and CD137, in the second half of 2020 and to initiate a Phase 1 trial in patients with advanced cancers in the first quarter of 2021.
The Exchange (see page 117)
Spring Bank will acquire the entire issued and outstanding share capital of F-star (including all shares issuable in connection with the F-star Note Conversion, the F-star Share Conversion and the Pre-Closing Financing, each as defined below). The combined company, operating under the name F-star Therapeutics, Inc., will seek to advance F-stars immuno-oncology pipeline of multiple tetravalent bispecific antibody programs, as well as Spring Banks STING agonist, SB 11285, currently in a Phase 1a/1b clinical trial.
At the Closing, each ordinary share of F-star will be acquired by Spring Bank in exchange for a number of shares of Spring Bank common stock, $0.0001 par value per share, based on the Exchange Ratio (defined below), rounded to the nearest whole share of Spring Bank common stock after aggregating all fractional shares issuable to each Seller. The Exchange Ratio may be adjusted (i) to the extent that Spring Banks expected net cash as of Closing is less than $15.0 million or greater than $17.0 million, (ii) to the extent that F-star does not raise at least $25.0 million in the Pre-Closing Financing at a pre-money valuation, or the valuation of F -star prior to receiving any proceeds from the Pre-Closing Financing, of at least $35.0 million, and (iii) to account for the actual proceeds raised in the Pre-Closing Financing. Should the Closing occur after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. The assumed valuations and Exchange Ratio are likely to change, and the parties currently expect the Closing to occur during the fourth quarter of 2020. These and other adjustments to the Exchange Ratio are described further in this proxy statement/prospectus. Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the Spring Bank securityholders and holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion and Pre-Closing Financing) are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company. Following the Closing, control of the combined company will be vested in the former holders of F-star and the board of directors of the combined company will include a total of eight directors, three of whom will be current directors of Spring Bank and five of whom will be designated by F-star.
The Pre-Closing Financing
Concurrently with the execution of the Exchange Agreement, certain existing investors of F-star, pursuant to binding equity commitment letters by and between each investor and F-star, agreed to subscribe for ordinary shares of F-star in a private placement to occur immediately prior to the Closing. As of , 2020, F-star had received commitments from investors to purchase $ million of ordinary shares of F-star in the Pre-Closing Financing. F-star may continue to seek additional commitments in the Pre-Closing Financing until 11:59 p.m., Eastern time on the 10th day prior to the Special Meeting. Ordinary shares of F-star sold in the Pre-Closing Financing will be exchanged for shares of Spring Bank common stock in the Exchange.
The F-star Share Conversion and F-star Note Conversion
F-stars issued share capital currently consists of ordinary shares, Seed Preference Shares and Series A Preference Shares. Immediately prior to the Closing, the Seed Preference Shares and Series A Preference Shares will be converted into F-star ordinary shares (the F-star Share Conversion). Additionally, pursuant to the terms of the Exchange Agreement and immediately prior to the Closing, all issued and outstanding F-star convertible loan notes will convert into F-star ordinary shares (the F-star Note Conversion).
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Equity Plans
All unvested issued and outstanding Spring Bank options and restricted stock units will be accelerated and vested in full immediately prior to the Closing and, following this acceleration, each option that has not previously been exercised will expire on the date of the Closing. All issued and outstanding F-star share options granted under its three legacy equity incentive plans are currently exercisable, and prior to the Closing, the holders of F-star Legacy Options will be notified by the F-star Board of Directors that they may exercise their F-star Legacy Options conditional upon and effective at the Closing. Upon the Closing, all holders of share options and restricted stock unit awards granted by F-star under the F-star 2019 Equity Incentive Plan will have those awards replaced by options and awards, on the same terms (including vesting), for Spring Bank common stock, based on the Exchange Ratio.
Closing
The Closing will occur no later than two business days after the last of the conditions as set forth in the Exchange Agreement has been satisfied or waived (other than those conditions that by their nature are to be satisfied at the Closing, but subject to the satisfaction or waiver of each such condition), or at such other time as Spring Bank and F-star agree. Spring Bank and F-star anticipate that the Closing will occur in the fourth quarter of 2020. However, because the Exchange is subject to a number of conditions, neither Spring Bank nor F-star can predict exactly when the Closing will occur or if it will occur at all. Upon completion of the Exchange, Spring Bank will be renamed F-star Therapeutics, Inc.
Reasons for the Exchange (see page 129)
Spring Bank and F-star believe that the combined company will have the following potential advantages:
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F-stars Promising Clinical-Stage Assets. F-star is a clinical-stage immuno-oncology company with multiple promising and innovative clinical-stage therapeutic programs, near-term milestones, and an accomplished oncology development leadership team. F-star believes that its product candidates will overcome many of the challenges facing current immuno-oncology therapies. F-stars vision is to transform the treatment of cancer through the development of differentiated and well-tolerated mAb2 bispecific antibodies, which are designed to simultaneously address multiple immune evasion pathways that limit the effect of current immuno-oncology therapies. |
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Management Team. The combined company will be led by a senior management from F-star experienced in immuno-oncology clinical drug development under the supervision of an experienced, well-qualified board of directors with representation from each of the current boards of directors of Spring Bank and F-star. |
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Cash Resources. The combined company is expected to have sufficient cash from the Pre-Closing Financing and cash on hand to enable it to implement its near-term business plans, and the combined company will have greater access to the public market to raise additional funds in the future. |
Each of the boards of directors of Spring Bank and F-star also considered other reasons for the Exchange, as described herein. For example, the Spring Bank Board of Directors (the Spring Bank Board) considered, among other things:
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the Spring Bank Boards belief that maintaining Spring Bank as an independent stand-alone company involved significant risk and the potential for significant dilution to the Spring Bank stockholders, taking into account Spring Banks business, operational and financial status and prospects, including its cash position, the substantially diminished price of the Spring Bank common stock following the termination of Spring Banks lead clinical development program, uncertainty regarding the successful clinical development of Spring Banks remaining clinical program, given its early stage of development, and the need to raise significant additional financing for the future development of Spring Banks remaining clinical product candidate in a volatile market; |
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the Spring Bank Boards belief, based in part on the judgment, advice and analysis of Spring Bank senior management with respect to the potential strategic, financial and operational benefits of the Exchange, that F-stars multiple promising clinical-stage therapeutic programs in the area of immuno-oncology, and the potential for near-term milestones, would result in a greater probability of providing value to Spring Banks stockholders than Spring Bank continuing as an independent stand-alone company; |
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that the Spring Bank stockholders could potentially receive significant future payments pursuant to the CVRs in the event of certain business development transactions involving Spring Banks STING agonist compound and its STING antagonist program during specified future periods; |
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the Spring Bank Boards belief that if Spring Bank were to raise sufficient capital to develop Spring Banks SB 11285 clinical program and conduct the necessary IND-enabling activities for the lead STING antagonist development candidate as a stand-alone company, the resulting dilution to existing Spring Bank stockholders would have been greater than the dilution resulting from the Exchange; |
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the Spring Bank Boards consideration of the valuation and business prospects of the other strategic combination candidates involved in its thorough strategic review process, and its collective view that F-star was the most attractive candidate for Spring Bank due to, among other things, F-stars belief that its tetravalent mAb2 bispecific antibodies may overcome many of the challenges facing current immuno-oncology therapies, and that F-stars potential to achieve key milestones over the next two years could enable the combined company to access the public markets for additional financial resources; and |
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the significant risks and delays associated with, and uncertain value and costs to Spring Bank stockholders of, a potential liquidation of Spring Bank. |
In addition, the F-star Board of Directors approved the Exchange based on a number of factors, including the following:
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historical and current information concerning F-stars business, including its financial performance and condition, operations, management and competitive position; |
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current industry and economic conditions and F-stars prospects if it were to remain an independent company, including its need to obtain additional financing and the terms on which it would be able to obtain such financing, if at all; |
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the cash resources of the combined company expected to be available at the Closing and the anticipated burn rate of the combined company; |
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the potential for increased access to sources of capital and a broader range of investors to support the development of F-stars product candidates than it could otherwise obtain if it continued to operate as a privately held company; |
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the potential to provide its current shareholders with greater liquidity by owning stock in a public company; and |
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the expectation that the Exchange with Spring Bank would be a more time- and cost-effective means to access capital than other options considered. |
Opinion of the Spring Bank Financial Advisor (see page 133)
Pursuant to an engagement letter dated March 20, 2020, Spring Bank retained Ladenburg to act as a financial advisor in connection with the Exchange and to render an opinion to the Spring Bank Board (the Opinion) as to the fairness, from a financial point of view of the Acquisition Consideration (as defined in the Opinion) to the Spring Bank stockholders. On July 27, 2020, at the request of the Spring Bank Board, Ladenburg rendered the oral opinion, subsequently confirmed by delivery of the written opinion dated July 27, 2020, to the Spring Bank Board, that the Acquisition Consideration was fair, from a financial point of view, to the Spring
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Bank stockholders as of the date of the Opinion and based upon the various assumptions, qualifications and limitations set forth in the Opinion.
The full text of the Opinion is attached as Annex B to this proxy statement/prospectus and is incorporated by reference. Spring Bank encourages its stockholders to read the Opinion in its entirety for the assumptions made, procedures followed, other matters considered and limits of the review by Ladenburg. The summary of the Opinion set forth herein is qualified by reference to the full text of the Opinion. Ladenburg provided its Opinion for the sole benefit and use by the Spring Bank Board in its consideration of the Exchange. The Opinion is not a recommendation to the Spring Bank Board or to any stockholder as to how to vote with respect to the proposed Exchange or to take any other action in connection with the Exchange or otherwise.
Overview of the Exchange Agreement
Exchange Consideration and Adjustment (see page 152)
Immediately prior to the Closing, in the F-star Share Conversion, all of the issued and Seed Preference Shares and Series A Preference Shares of F-star will convert into ordinary shares of F-star, and all outstanding F-star convertible loan notes will convert into ordinary shares of F-star. At the Closing, each F-star ordinary share will be converted into the number of shares of Spring Bank common stock determined by the exchange ratio formula set forth in the Exchange Agreement,(the Exchange Ratio) subject to certain adjustments and to account for the anticipated Reverse Stock Split.
Immediately following the Closing, based on an assumed Exchange Ratio of 0.5338, the owners of F-star securities are expected to own approximately 61.2% of the combined company, and the owners of Spring Banks securities, whose shares of Spring Bank common stock and other securities will remain outstanding after the Exchange, will own approximately 38.8% of the combined company.
The ownership percentages for each party are subject to adjustment of the Exchange Ratio. Spring Banks valuation has been determined to be $38 million, which amount is subject to adjustment in the event that Spring Banks net cash as of immediately prior to the closing is less than $15.0 million or greater than $17.0 million, in which case, Spring Banks valuation would be decreased or increased, respectively, on a dollar-for-dollar basis by the amount that Spring Banks actual net cash is less than $15.0 million or greater than $17.0 million, respectively. As noted above, should the Closing occur after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. The assumed valuations and Exchange Ratio are likely to change, and the parties currently expect the Closing to occur during the fourth quarter of 2020. F-stars valuation is the sum of the lesser of the pre-money valuation attributed to F-star for purposes of the Pre-Closing Financing and $35.0 million, minus the amount, if any, by which $25.0 million exceeds the aggregate subscription amount for which F-star has received executed equity commitment letters as of the 10th day preceding the Stockholders Meeting, plus the proceeds actually received by F-star in the Pre-Closing Financing.
The Exchange Ratio is calculated based on the respective allocation percentages for Spring Bank and F-star. Spring Banks allocation percentage is the quotient of Spring Banks valuation, as adjusted as described above, divided by the sum of the Spring Bank valuation and the F-star post-financing valuation, referred to herein as the Aggregate Valuation. F-stars allocation percentage is the quotient of F-stars valuation, as adjusted as described above, divided by the Aggregate Valuation.
The Exchange Agreement does not include a price-based termination right, and there will be no adjustment to the total number of shares of Spring Bank common stock that F-star shareholders will be entitled to receive for changes in the market price of Spring Bank common stock. Accordingly, the market value of the shares of Spring Bank common stock issued pursuant to the Exchange will depend on the market value of the shares of Spring Bank common stock at the time the Exchange closes and could vary significantly from the market value on the date of this proxy statement/prospectus.
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Treatment of F-star Options and F-star Restricted Stock Units (see page 163)
Prior to (and conditional upon and effective as of) the Closing, the Spring Bank Board will cause Spring Bank to assume the F-star Therapeutics Limited 2019 Equity Incentive Plan (the F-Star EIP, also referred to as the Assumed Plan). Thereafter, the Spring Bank Board will, conditional upon and effective immediately the Closing, offer to grant each holder of outstanding options granted under the F-star EIP (the Original EIP Options), in exchange for each of the holders Original EIP Options, a replacement option under the Assumed Plan (a Replacement EIP Option), which will be an option to subscribe for or purchase shares of Spring Bank common stock. The vesting schedule and vesting dates applicable to each Replacement EIP Option will be the same as the vesting schedule applicable to the Original EIP Option that it replaces. The aggregate number of shares of Spring Bank common stock issuable on exercise in full of each Replacement EIP Option will be calculated by applying the Exchange Ratio to the number of F-star ordinary shares issuable on exercise in full of the Original EIP Option that it replaces, and rounding the resulting number down to the nearest whole number of shares of Spring Bank common stock. The aggregate exercise price payable to exercise in full each Replacement EIP Option will be the same as the aggregate exercise price payable to exercise in full the Original EIP Option that it replaces; provided, however, that the exercise price with respect to a Replacement EIP Option may be adjusted, as required by the Exchange Agreement, with respect to any option granted to a United States participant under the F-star EIP.
Each holder of outstanding restricted stock units granted under the F-star EIP (the Original EIP RSUs) will, immediately after the Closing and in exchange for the holders Original EIP RSUs, be granted replacement restricted share units (Replacement EIP RSUs). The Replacement EIP RSUs will be granted under the Assumed Plan and will be a right to acquire shares of Spring Bank common stock. The number of shares of Spring Bank common stock issuable on vesting in full of each Replacement EIP RSU will be calculated by applying the Exchange Ratio to the number of F-star ordinary shares issuable on vesting in full of the Original EIP RSU that it replaces, and rounding the resulting number down to the nearest whole number of shares of Spring Bank common stock.
The Replacement EIP RSUs and the Replacement EIP Options with respect to Original EIP Options granted to U.S. participants will be subject to the same terms and conditions as the Original EIP RSUs and Original EIP Options, respectively (except to the extent such terms are rendered inoperative as a result of the transactions contemplated by the Exchange Agreement), and will not provide holders of the Replacement EIP Options or Replacement EIP RSUs with any additional benefits that the holders did not have under their Original EIP Options or Original EIP RSUs. Similarly, the grant of Replacement EIP Options in exchange for the release of Original EIP Options shall be effected in such manner as shall meet the requirements of Part 6 of Schedule 5 to the Income Tax (Earnings and Pensions) Act 2003 (an act of the UK Parliament) (ITEPA 2003) so as to ensure that each Replacement EIP Option shall qualify as Replacement Options under the said Part 6 of Schedule 5 to ITEPA 2003.
Prior to the Closing, each holder of options granted under the: (i) F-star Alpha Limited Share Option Scheme (each, an F-star Alpha Legacy Option); (ii) F-star Beta Limited Share Option Scheme (each, an F-star Beta Legacy Option); and (iii) F-star Gmbh Limited Share Option Scheme (each, an F-star Gmbh Legacy Option, and together with the F-star Alpha Legacy Options and the F-star Beta Legacy Options, the F-star Legacy Options) will be notified by the F-star Board of Directors that they may exercise their F-star Legacy Options conditional upon and effective at the Closing. Spring Bank will not assume any of the F-star Legacy Options or the F-star Alpha Limited Share Option Scheme, the F-star Beta Limited Share Option Scheme or the F-star Gmbh Limited Share Option Scheme and shall not make an offer of replacement options in respect of the F-star Legacy Options.
Conditions to the Completion of the Exchange (see page 164)
To consummate the Exchange, Spring Bank stockholders must approve the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and approve and adopt the amendments to the
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amended and restated certificate of incorporation of Spring Bank effecting the proposed Reverse Stock Split and the Spring Bank Name Change. In addition to obtaining such stockholder approvals and appropriate regulatory approvals, each of the other closing conditions set forth in the Exchange Agreement must be satisfied or waived.
No Solicitation (see page 168)
Each of Spring Bank and F-star agreed that, subject to limited exceptions, Spring Bank and F-star will not, nor will either party authorize or permit any of its subsidiaries or authorize the officers, directors, employees, partners, attorneys, advisors, accountants, agents or representatives of it or any of its subsidiaries to, directly or indirectly:
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solicit or initiate, or knowingly encourage, induce or facilitate the making, submission or announcement of, any Acquisition Proposal, in the case of Spring Bank, or an F-star Acquisition Proposal, in the case of F-star, each as defined in The Exchange Agreement Spring Bank Acquisition Proposal and Acquisition Transaction and The Exchange Agreement F-star Acquisition Proposal, respectively, or take any action that would reasonably be expected to lead to an Acquisition Proposal or F-star Acquisition Proposal, as the case may be; |
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furnish any non-public information with respect to it or any of its subsidiaries to any person in connection with or in response to an Acquisition Proposal or F-star Acquisition Proposal, as the case may be, or an inquiry or indication of interest that would reasonably be expected to lead to an Acquisition Proposal or F-star Acquisition Proposal, as the case may be; |
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engage in discussions or negotiations with any person with respect to any Acquisition Proposal or F-star Acquisition Proposal, as the case may be; |
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approve, endorse or recommend an Acquisition Proposal or an F-star Acquisition Proposal, as the case may be; or |
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enter into any letter of intent or similar document or any agreement providing for or otherwise relating to, with respect to Spring Bank, an Acquisition Transaction, as defined in The Exchange Agreement Spring Bank Acquisition Proposal and Acquisition Transaction or with respect to F-star, a transaction contemplated by an F-star Acquisition Proposal. |
Termination (see page 175)
Either Spring Bank or F-star can terminate the Exchange Agreement under certain circumstances, which would prevent the Exchange from being consummated.
Termination Fee; Expenses (see page 177)
The Exchange Agreement contains certain termination rights for both Spring Bank and F-star, and further provides that, upon termination of the Exchange Agreement under specified circumstances, either party may be required to pay the other party a termination fee of $2.0 million, or, in the case of Spring Bank in some circumstances, reimburse F-stars expenses up to a maximum amount of $750,000.
Voting Agreements (see page 179)
Each of the officers and directors and certain stockholders of Spring Bank have entered into voting agreements with F-star (the Voting Agreements) pursuant to which they agreed to vote in favor of approval of (i) issuance of Spring Bank common stock to the holders of F-star share capital pursuant to the Exchange and the change of control of Spring Bank resulting from the Exchange pursuant to The Nasdaq Stock Market LLC (Nasdaq Listing Rules 5635(a) and 5635(b), respectively), (ii) an amendment to Spring Banks amended and restated certificate of incorporation effecting the Reverse Stock Split, (iii) an amendment to Spring Banks amended and restated certificate of incorporation effecting the Spring Bank Name Change upon Closing, (iv) any proposal to postpone or adjourn the Special Meeting to a later date, if there are not sufficient votes for the approval of the Exchange and other matters to be approved on date of the Special Meeting, and (v) any other
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proposal included in this proxy statement/prospectus in connection with, or related to, the consummation of the Exchange for which the Spring Bank Board has unanimously recommended that the stockholders of Spring Bank vote in favor.
The Spring Bank stockholders that are party to the Voting Agreements owned approximately 7.7% of the outstanding shares of Spring Bank common stock as of September 15, 2020.
Lock-up Agreements (see page 179)
As a condition to the Closing, certain Spring Bank stockholders and F-star shareholders have entered into lock-up agreements, pursuant to which they agreed not to, except in limited circumstances, sell or transfer, or engage in swap or similar transactions with respect to, shares of Spring Bank common stock, including, as applicable, shares received in the Exchange and issuable upon exercise of certain options, during the 180-day period following the Closing.
As of September 15, 2020, Spring Bank stockholders who have executed lock-up agreements owned in the aggregate approximately 7.7% of the outstanding shares of Spring Bank common stock.
F-star shareholders who have executed lock-up agreements as of September 15, 2020 owned in the aggregate approximately 92.2% of the outstanding shares of F-star share capital on an as converted into common stock basis.
Contingent Value Rights Agreements (see page 179)
Spring Bank stockholders will receive two separate and distinct CVRs for each share of Spring Bank common stock held of record as of immediately prior to the Closing. The CVRs will represent the rights to receive cash payments in connection with (i) certain transactions involving Spring Banks proprietary STING agonist compound and (ii) certain other transactions involving Spring Banks proprietary STING antagonist compound.
Pursuant to the STING Agonist Contingent Value Rights Agreement, each share of Spring Bank common stock held by Spring Bank stockholders as of a record date immediately prior to the Closing will be entitled to receive, in connection with certain transactions involving Spring Banks proprietary STING agonist compound occurring on or prior to an agreed-upon expiration date, an aggregate amount equal to the greater of (i) 25% of the Net Proceeds received from all STING Agonist CVR Transactions (each as defined in the STING Agonist Contingent Value Rights Agreement) and (ii) up to an aggregate amount of $18.0 million, the product of $1.00 (as adjusted for the Reverse Stock Split, to the extent applicable) and the total number of shares of Spring Bank common stock outstanding as of a record date immediately prior to the Closing. Pursuant to the STING Antagonist Contingent Value Rights Agreement, each share of Spring Bank common stock held by Spring Bank stockholders as of a record date immediately prior to the Closing will be entitled to receive, in connection with the execution of an Approved Development Agreement and certain other transactions involving Spring Banks proprietary STING antagonist compound occurring during the 7-year period after the Closing, an aggregate amount equal to 80% of all Net Proceeds (as defined in the STING Antagonist Contingent Value Rights Agreement) received by Spring Bank after the Closing pursuant to (i) the Approved Development Agreement, if any, and (ii) all STING Antagonist CVR Transactions (as defined in the STING Antagonist Contingent Value Rights Agreement) entered into during the seven-year period after the Closing.
Management Following the Exchange (see page 320)
Effective as of the Closing, the officers of the combined company are expected to include:
Name |
Title |
|
Eliot Forster, Ph.D. |
President, Chief Executive Officer and Director | |
Darlene Deptula-Hicks |
Chief Financial Officer and Treasurer |
|
Neil Brewis, Ph.D. |
Chief Scientific Officer |
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Louis Kayitalire, M.D. |
Chief Medical Officer |
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Interests of Directors, Officers and Affiliates of Spring Bank and F-star (see pages 142 and 146)
When considering the recommendations of the Spring Bank Board, Spring Bank stockholders should be aware that certain Spring Bank directors and executive officers have interests in the Exchange that are different from, or are in addition to, theirs. Upon completion of the Exchange, if the employment of Martin Driscoll, R. P. Kris Iyer, Ph.D., Lori Firmani and Garrett Winslow, is terminated by Spring Bank without cause, these executive officers will be entitled to certain severance and retention payments and employment benefits following their respective terminations. All unvested issued and outstanding Spring Bank options and restricted stock units will be accelerated and vested in full immediately prior to the Closing and, following this acceleration, each option that has not previously been exercised will expire on the date of the Closing. As of September 15, 2020, the aggregate value of these severance and retention payments, benefits and vesting acceleration is $2,163,998 (collectively, not individually). Additionally, David Arkowitz, Todd Brady, M.D., Ph.D. and Pamela Klein, M.D., current members of the Spring Bank Board, will continue to serve as members of the combined companys board of directors after the Exchange.
F-star shareholders should be aware that certain members of the F-star Board of Directors and certain executive officers of F-star have interests in the Exchange that may be different from, or in addition to, interests they have as F-star shareholders. For example, F-stars executive officers have options, subject to vesting, to purchase F-star ordinary shares, which will convert into options to purchase a number of shares of Spring Bank common stock determined by the Exchange Ratio, rounding any resulting fractional shares down to the nearest whole share, certain of F-stars directors and executive officers are expected to become directors and executive officers of the combined company upon the Closing and all of F-stars directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Exchange Agreement.
Material U.S. Federal Income Tax Consequences of the Exchange (see page 156)
Spring Bank and F-star intend to treat the Exchange as constituting a reorganization within the meaning of Section 368(a)(1)(B) of the Internal Revenue Code of 1986, as amended (a B-Reorganization). As further described in the above referenced section of this proxy statement/prospectus, whether the Exchange constitutes a B-Reorganization is uncertain. In general, and subject to the qualifications and limitations set forth in the above referenced section of this proxy statement/prospectus, if the Exchange qualifies as a B-Reorganization, the material tax consequences to a U.S. Holder of F-star capital stock should be as follows:
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such F-star shareholder will not recognize gain or loss upon the exchange of F-star capital stock for Spring Bank common stock pursuant to the Exchange; |
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such F-star shareholders aggregate tax basis for the shares of Spring Bank common stock received in the Exchange will equal the stockholders aggregate tax basis in the shares of F-star capital stock surrendered in the Exchange; and |
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the holding period of the shares of Spring Bank common stock received by such F-star shareholder in the Exchange will include the holding period of the shares of F-star capital stock surrendered in exchange therefor. |
If the Exchange is not treated as a B-Reorganization, then each U.S. Holder generally will be treated as exchanging its shares of F-star capital stock in a fully-taxable transaction in exchange for shares of Spring Bank common stock. F-star shareholders will generally recognize gain or loss in such exchange equal to the amount that such F-star shareholders adjusted tax basis in the shares of F-star capital stock surrendered is less or more than the fair market value of the shares of Spring Bank common stock received in exchange therefor. Determining the actual tax consequences of the Exchange to you may be complex and will depend on the facts of your own situation. You should consult your tax advisors to fully understand the tax consequences to you of the Exchange, including estate, gift, state, local or non-U.S. tax consequences of the Exchange.
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Material U.K. Income Tax Consequences of the Exchange (see page 159)
The summary set out below is based on current United Kingdom (UK) tax law and HM Revenue and Customs (HMRC) practice (which may not be binding on HMRC) as of the date of this proxy statement/prospectus, both of which are subject to change, possibly with retrospective effect.
Spring Bank and F-star intend the Exchange to qualify as a UK tax free reorganization. Subject to certain conditions, the Capital Gains Tax (CGT) legislation in Section 135 TCGA 1992 provides that F-star shares exchanged for Spring Bank Shares may be treated for UK tax residents as a reorganization of the original holding such that the Spring Bank Shares may be treated as if they were the original F-star stockholding and there should be no disposal for CGT purposes as a result of such reorganization.
The conditions of Section 135 TCGA 1992 are:
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Spring Bank will hold more than 25% of the original share capital of F-star; and |
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The exchange of securities takes place for bona fide commercial reasons and does not form part of a scheme or arrangements, of which the main purpose, or one of the main purposes is the avoidance of liability to CGT (Section 137 TCGA 1992). |
Advance clearance from HMRC under Section 138 TCGA 1992 that the bona fide commercial reasons test applies has been received. It should be noted that this test should only be relevant in the case of stockholders who (together with persons connected with them) currently hold more than 5% of F-star shares.
Advance clearance has also been obtained from HMRC under Section 701 ITA 2007 and Section 748 CTA 2010 that the main purpose, or one of the main purposes, of the Exchange is not to obtain an income tax or corporation tax advantage for UK individual or corporate stockholders, so that the transactions in securities rules should not apply to recharacterize the Exchange into a taxable event from the perspective of such individuals or corporates.
In the event that the conditions of Section 135 TCGA 1992 are not met, the Exchange is a chargeable event under the provisions of the CGT legislation. Each UK stockholder of F-star share capital will generally recognize a chargeable gain or loss on the receipt of shares of Spring Bank common stock issued to such holder of F-star share capital.
Risk Factors (see page 30)
Both Spring Bank and F-star are subject to various risks associated with their businesses and their industries. In addition, the Exchange poses a number of risks to each company and its respective stockholders, including the possibility that the Exchange may not be completed and the following risks:
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The issuance of Spring Bank common stock to holders of F-star share capital pursuant to the Exchange Agreement and the resulting change in control from the Exchange must be approved by Spring Bank stockholders. Failure to obtain these approvals or meet other conditions set forth in the Exchange Agreement would prevent the Closing of the Exchange. |
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The Exchange Ratio may be adjusted depending on Spring Banks net cash at Closing, the timing of Closing and the amount of gross proceeds received in the Pre-Closing Financing such that the Spring Bank securityholders and F-star securityholders may own more or less of the combined company that presented in this proxy statement/prospectus. |
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The Exchange Ratio set forth in the Exchange Agreement is not adjustable based on the market price of Spring Bank common stock, so the Exchange consideration at the Closing may have a greater or lesser value than at the time the Exchange Agreement was signed. |
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Failure to complete the Exchange may result in either Spring Bank or F-star paying a termination fee to the other party and could significantly harm the market price of Spring Bank common stock and negatively affect the future business and operations of each company. |
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The Exchange may be completed even though certain events occur prior to the Closing that materially and adversely affect Spring Bank or F-star. |
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Some Spring Bank and F-star officers and directors have interests in the Exchange that are different from the respective stockholders of Spring Bank and F-star and that may influence them to support or approve the Exchange without regard to the interests of the respective Spring Bank stockholders or holders of F-star share capital. |
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The market price of Spring Bank common stock following the Exchange may decline as a result of the Exchange. |
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Spring Bank stockholders may not receive any payment on the CVRs and the CVRs may otherwise expire valueless. |
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The Spring Bank stockholders and holders of F-star share capital may not realize a benefit from the Exchange commensurate with the ownership dilution they will experience in connection with the Exchange. |
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During the pendency of the Exchange, Spring Bank and F-star may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Exchange Agreement, which could adversely affect their respective businesses. |
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Certain provisions of the Exchange Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Exchange Agreement. |
These risks and other risks are discussed in greater detail under the section titled Risk Factors in this proxy statement/prospectus. Spring Bank and F-star both encourage you to read and consider all of these risks carefully.
Regulatory Approvals (see page 156)
In the United States, Spring Bank must comply with applicable federal and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Spring Bank common stock and the filing of this proxy statement/prospectus with the SEC.
Nasdaq Capital Market Listing (see page 160)
Spring Bank intends to file an initial listing application with the Nasdaq Capital Market pursuant to Nasdaqs rules for companies conducting a business combination that results in a change of control. If this application is accepted, Spring Bank anticipates that shares of Spring Bank common stock will be listed on the Nasdaq Capital Market following the Closing under Spring Banks new name, F-star Therapeutics, Inc., with the trading symbol FSTX.
Anticipated Accounting Treatment (see page 160)
The Exchange will be recorded as a business combination using the acquisition method of accounting in accordance with Accounting Standards Codification Topic 805, Business Combinations. Accounting principles generally accepted in the United States (U.S. GAAP) require that one of the two companies in a business combination be designated as the acquirer for accounting purposes based on evidence available. F-star will be treated as the acquiring entity for accounting purposes. In identifying F-star as the acquiring entity for accounting purposes, F-star and Spring Bank took into account factors including, but not limited to, the anticipated voting rights of all equity instruments following the Exchange, the intended corporate governance structure of the combined company, composition of senior management, and the relative size of each of the companies. No single factor was the sole determinant in the overall conclusion that F-star has been designated as the acquirer for accounting purposes; rather, all factors were considered in arriving at this conclusion.
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Management of F-star and Spring Bank have determined a preliminary estimate of the purchase price calculated as described in Note 2 to the unaudited pro forma condensed combined financial statements included in this proxy statement/prospectus. The net tangible assets acquired and liabilities assumed of Spring Bank in connection with the Exchange are recorded at their estimated acquisition date fair values. The acquisition method of accounting is dependent upon certain valuations and any other studies and calculations deemed necessary that have yet to commence or progress to a stage where there is sufficient information for a definitive measurement. A final determination of these estimated fair values, which cannot be made prior to the completion of the transaction, will be based on the actual net tangible assets of Spring Bank that exist as of the date of completion of the Exchange.
Appraisal Rights and Dissenters Rights (see page 161)
Under the Delaware General Corporation Law (DGCL), the stockholders of Spring Bank do not have appraisal rights in connection with the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and the resulting change of control of Spring Bank. F-star shareholders generally do not have appraisal rights under English law.
Comparison of Rights of Holders (see page 346)
Spring Bank is incorporated under the laws of the State of Delaware, and the rights of stockholders of Spring Bank are currently, and will continue to be, governed by the DGCL. The internal affairs of Spring Bank are currently, and will continue to be, governed by Spring Banks amended and restated certificate of incorporation and bylaws. F-star is registered in England and Wales, and the rights of F-star shareholders are currently governed by the Companies Act 2006. The internal affairs of F-star are currently governed by F-stars articles of association and the shareholders agreement between F-star and its shareholders.
After the Closing, F-star shareholders will become stockholders of Spring Bank. Due to the differences between the governing laws and documents of F-star and Spring Bank, the Exchange will result in F-star shareholders having different rights once they become Spring Bank stockholders.
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SELECTED HISTORICAL AND UNAUDITED PRO FORMA
CONDENSED COMBINED FINANCIAL DATA
The following tables present summary historical financial data for Spring Bank and F-star, summary unaudited pro forma condensed financial data for Spring Bank and F-star, and comparative historical and unaudited pro forma per share data for Spring Bank and F-star.
Selected Historical Financial Data of Spring Bank
Not required for smaller reporting companies.
Selected Historical Financial Data of F-star
F-star Therapeutics Limited (F-star) acquired F-star Delta Limited (F-star Delta), F-star Beta Limited (F-star Beta), f-star Biotechnologische Forschungs-und Entwicklungsges, m.b.H. (F-star GmbH), and F-star Alpha Limited (F-star Alpha), (collectively, the F-star Group Entities) on May 7, 2019. F-star Beta and F-star GmbH, are deemed to be predecessor entities (the Predecessor Group or together with F-Star, the Entities), as described in the F-star Managements Discussion and Analysis of Financial Condition and Results of Operations section included elsewhere in this proxy statement/ prospectus. Accordingly, the selected historical financial data as of and for the years ended December 31, 2019, 2018 and 2017 for F-star and for the period ended May 6, 2019, and the years ended December 31, 2018 and 2017 for F-star GmbH and F-star Beta are set forth below. Historical financial statements of F-star reflect the results of operations and historical financial position and financial performance of F-star Delta only, as the accounting acquirer, for the years ended December 31, 2018 and 2017. F-star, the legal acquirer of the F-star Group Entities, is an entity with no historical operations and was created solely for the purpose of effecting the corporate reorganization. For accounting purposes, F-star is not deemed substantive and not deemed the accounting acquirer.
F-star Deltas financial information is included for the full year ended December 31, 2019 within the consolidated F-star financial statements and hence no separate financial information is presented for F-star Delta in the period to May 6, 2019. The selected historical financial data as of and for the period ended May 6, 2019 and the years ended December 31, 2019, 2018 and 2017 has been derived from the audited historical financial statements of the Entities, which are included elsewhere in this proxy statement/prospectus (see table below). F-star prepares its financial statements in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.
The historical financial data for the years ended December 31, 2018 and 2017 has been restated for F-star (F-star Delta, the accounting acquirer). See Note 4.9 of the F-star audited consolidated financial statements for the year ended December 31, 2019. Following a management review of the presentation of the statement of (loss)/income for the current reporting period, it was determined that a by function presentation would provide more reliable and relevant information to the users of F-star and F-star Beta financial statements. See Note 2.1 to audited financial statements of F-star and Note 2.1 to the audited financial statements of F-star Beta.
The historical results of the Entities are not necessarily indicative of future performance. You should read the information in this section in conjunction with Unaudited Pro Forma Condensed Combined Financial Statements, and F-star Managements Discussion and Analysis of Financial Condition and Results of Operations, and the historical financial statements of the Entities that are included elsewhere in this proxy statement/ prospectus. F-stars IFRS historical financial statements and information are not comparable to Spring Banks U.S. GAAP historical financial statements and information included in this proxy statement/ prospectus. Furthermore, because the financial statements of F-star and F-star Beta are presented in pounds sterling and the financial statements of F-star GmbH are presented in euro and not in U.S. dollars, they are not directly comparable to Spring Banks financial statements and financial information included in this proxy statement/ prospectus.
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Entities Included in the F-star Consolidated Financial Statements
Six Months Ended June 30, |
Years Ended December 31, |
|||||||||
Entities |
2020 |
2019 |
2019 |
2018 | 2017 | |||||
F-star Delta |
Full 6
months |
Full 6 months | Full Year | Full Year | Full Year | |||||
F-star |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | | |||||
F-star GmbH |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | | |||||
F-star Beta |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | | |||||
F-star Alpha |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | |
The financial results of F-star Alpha, F-star Beta and F-star GmbH are consolidated from and as a result of the reorganization on May 7, 2019, with F-star Delta as the accounting acquirer.
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F-star Therapeutics Limited (F-star)
(all amounts are presented in GBP)
Unaudited Condensed Consolidated Statement of Comprehensive Loss
6 months ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Revenue |
£ | 1,537 | £ | 20,154 | (£18,616) | |||||||
Costs related to collaborative arrangements |
(333 | ) | (17,437 | ) | 17,104 | |||||||
Research and development costs |
(7,423 | ) | (9,575 | ) | 2,152 | |||||||
General and administrative expenses |
(4,960 | ) | (3,764 | ) | (1,196 | ) | ||||||
Other income |
371 | | 371 | |||||||||
Other expenses |
(1,282 | ) | (243 | ) | (1,040 | ) | ||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(12,090 | ) | (10,865 | ) | (1,225 | ) | ||||||
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) |
(1,509 | ) | | (1,509 | ) | |||||||
Finance income |
8 | 1 | 7 | |||||||||
Finance costs |
(438 | ) | | (438 | ) | |||||||
|
|
|
|
|
|
|||||||
Loss before tax from continuing operations |
(14,028 | ) | (10,864 | ) | (3,164 | ) | ||||||
Income tax credit |
2,692 | 756 | 1,936 | |||||||||
|
|
|
|
|
|
|||||||
Loss for the year attributable to equity holders of the parent |
(£11,336 | ) | (£10,108 | ) | (£1,228 | ) | ||||||
Basic and diluted loss per share |
(£0.64 | ) | (£0.86 | ) | £ | 0.22 |
24
Consolidated Statements of Comprehensive Income
Year ended December 31, | ||||||||||||
(in thousands, except per share data) | ||||||||||||
(Restated) | (Restated) | |||||||||||
2019 | 2018 | 2017 | ||||||||||
Revenue |
£ | 21,882 | £ | 29,997 | £ | 11,027 | ||||||
Costs related to collaborative arrangements |
(17,960 | ) | (13,892 | ) | (6,346 | ) | ||||||
Research & development expense |
(32,673 | ) | | | ||||||||
General & administrative expense |
(12,295 | ) | (399 | ) | (616 | ) | ||||||
Other income |
113 | | | |||||||||
Other gains |
310 | 195 | 71 | |||||||||
|
|
|
|
|
|
|||||||
(Loss)/ profit from operations |
(40,622 | ) | 15,900 | 4,136 | ||||||||
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) |
(1,106 | ) | | | ||||||||
Finance income |
8 | 4 | | |||||||||
Finance costs |
(256 | ) | | | ||||||||
|
|
|
|
|
|
|||||||
(Loss)/ profit before tax from continuing operations |
(41,976 | ) | 15,905 | 4,136 | ||||||||
|
|
|
|
|
|
|||||||
Income tax credit/(charge) |
7,016 | (2,636 | ) | (657 | ) | |||||||
|
|
|
|
|
|
|||||||
(Loss)/ profit for the year attributable to equity holders of the parent |
(34,959 | ) | 13,269 | 3,479 | ||||||||
|
|
|
|
|
|
|||||||
Items that may be reclassified to profit or loss in subsequent periods: |
||||||||||||
Foreign exchange arising on consolidation |
77 | | | |||||||||
|
|
|
|
|
|
|||||||
Other comprehensive income for the period |
77 | | | |||||||||
|
|
|
|
|
|
|||||||
Total comprehensive (loss)/ income attributable to owners of the parent |
(£34,882 | ) | £ | 13,269 | £ | 3,479 | ||||||
(Loss)/earnings per share for profit attributable to the shareholders of the parent: |
||||||||||||
(Loss)/earnings per share |
(£ 2.37 | ) | £ | 1.47 | £ | 0.38 | ||||||
(Loss)/earnings per share, after dilution |
(£ 2.37 | ) | £ | 1.47 | £ | 0.38 |
The historical financial statements of F-star reflect the results of operations and historical financial position and financial performance of F-star Delta only, as the accounting acquirer, for the years ended December 31, 2018 and 2017.
Selected Statements of Financial Position Data
As of December 31, | ||||||||||||
(in thousands) | ||||||||||||
(Restated) | (Restated) | |||||||||||
2019 | 2018 | 2017 | ||||||||||
Cash and cash equivalents |
£ | 3,736 | £ | 6,458 | £ | 3,780 | ||||||
Total assets |
53,102 | 24,979 | 13,964 | |||||||||
Total liabilities |
24,570 | 9,118 | 10,485 | |||||||||
Issued capital |
178 | | | |||||||||
(Accumulated losses)/ retained earnings |
(16,908 | ) | 15,861 | 3,479 | ||||||||
Total equity |
£ | 28,532 | £ | 15,861 | £ | 3,479 |
Selected Statement of Cash Flows Data
As of December 31, | ||||||||||||
(in thousands) | ||||||||||||
2019 | 2018 | 2017 | ||||||||||
Net cash (used in)/ generated from operating activities |
(£16,557 | ) | £ | 12,298 | £ | 13,627 | ||||||
Net cash generated from/ (used in) investing activities |
4,105 | (9,620 | ) | (9,846 | ) | |||||||
Net cash generated from financing activities |
£ | 9,733 | £ | £ |
25
f-star Biotechnologische Forschungs-und Entwicklungsges, M.B.H. (F-star GmbH) (Predecessor)
(All amounts presented in EUR)
Consolidated Statements of Comprehensive Income
Period Ended
May 6, |
Year Ended
December 31, |
|||||||||||
(in thousands, except per share data) | ||||||||||||
2019 | 2018 | 2017 | ||||||||||
Revenue |
| 9,058 | | 21,088 | | 15,749 | ||||||
Other income |
591 | 505 | 232 | |||||||||
Raw materials and consumables used |
(1,339 | ) | (3,960 | ) | (2,958 | ) | ||||||
Depreciation, amortization and loss on disposal |
(454 | ) | (835 | ) | (559 | ) | ||||||
Employee expenses |
(3,369 | ) | (7,995 | ) | (6,853 | ) | ||||||
Other expenses |
(3,087 | ) | (7,429 | ) | (5,613 | ) | ||||||
|
|
|
|
|
|
|||||||
Operating profit/ (loss) |
1,399 | 1,375 | (3 | ) | ||||||||
Finance income |
125 | 164 | 116 | |||||||||
Finance costs |
(109 | ) | (223 | ) | (201 | ) | ||||||
|
|
|
|
|
|
|||||||
Net finance income/ (costs) |
16 | (60 | ) | (85 | ) | |||||||
|
|
|
|
|
|
|||||||
Profit/(loss) before tax on ordinary activities |
1,415 | 1,315 | (88 | ) | ||||||||
Income tax (charge)/ credit |
(49 | ) | 195 | 225 | ||||||||
|
|
|
|
|
|
|||||||
Profit for the period |
1,366 | 1,510 | 137 | |||||||||
|
|
|
|
|
|
|||||||
Earnings per share |
2.26 | 2.50 | 0.23 | |||||||||
Earnings per share, after dilution |
2.15 | 2.50 | 0.23 |
Selected Consolidated Statements of Financial Position Data
As of
May 6, |
As of December 31, | |||||||||||
(in thousands) | ||||||||||||
2019 | 2018 | 2017 | ||||||||||
Cash and cash equivalents |
| 849 | | 2,053 | | 3,133 | ||||||
Total assets |
19,949 | 18,543 | 13,598 | |||||||||
Total liabilities |
20,518 | 20,019 | 9,696 | |||||||||
Share capitalordinary |
605 | 605 | 605 | |||||||||
Accumulated losses |
(32,533 | ) | (33,836 | ) | (28,328 | ) | ||||||
Total shareholders (deficit)/ equity |
(569 | ) | (1,477 | ) | 3,902 |
Selected Consolidated Statements of Cash Flows Data
Period Ended
May 6, |
Year Ended
December 31, |
|||||||||||
(in thousands) | ||||||||||||
2019 | 2018 | 2017 | ||||||||||
Net cash flows (used in) / generated from operating activities |
(2,253 | ) | | 6,680 | (273 | ) | ||||||
Net cash flows generated from/ (used in) investing activities |
127 | (7,518 | ) | (4,217 | ) | |||||||
Net cash flows generated from/ (used in) financing activities |
845 | (217 | ) | 2,079 |
26
F-star Beta Limited (F-star Beta) (Predecessor)
(All amounts presented in GBP)
Statements of Comprehensive Income
Period Ended
May 6, |
Year Ended
December 31, |
|||||||||||
(in thousands, except per share data) | ||||||||||||
2019 | 2018 | 2017 | ||||||||||
Revenue |
£ | 7,903 | £ | 17,394 | £ | 14,993 | ||||||
Costs related to collaborative arrangements |
(1,864 | ) | (6,719 | ) | (3,289 | ) | ||||||
Research and development costs |
(5,106 | ) | (12,049 | ) | (11,933 | ) | ||||||
General and administrative expenses |
(909 | ) | (345 | ) | (352 | ) | ||||||
Other gains |
| 1 | 165 | |||||||||
Other expenses |
(58 | ) | (20 | ) | | |||||||
|
|
|
|
|
|
|||||||
Loss on operations |
(34 | ) | (1,738 | ) | (414 | ) | ||||||
Finance costs |
(103 | ) | (145 | ) | (102 | ) | ||||||
|
|
|
|
|
|
|||||||
Loss before tax on continuing operation |
(137 | ) | (1,883 | ) | (516 | ) | ||||||
Corporation tax benefit |
639 | 2,416 | 705 | |||||||||
|
|
|
|
|
|
|||||||
Profit for the year and total comprehensive income attributable to the equity holders of the parent |
£502 | £533 | £189 | |||||||||
|
|
|
|
|
|
|||||||
Earnings per share |
£0.05 | £0.06 | £0.02 | |||||||||
Earnings per share, after dilution |
£0.05 | £0.06 | £0.02 |
Selected Statements of Financial Position Data
As of
May 6, |
As of December 31, | |||||||||||
(in thousands) | ||||||||||||
2019 | 2018 | 2017 | ||||||||||
Cash and cash equivalents |
£ | 915 | £ | 5,709 | £ | 1,910 | ||||||
Total assets |
5,727 | 9,408 | 5,030 | |||||||||
Total liabilities |
13,704 | 18,575 | 5,421 | |||||||||
Issued capital |
| | | |||||||||
Accumulated losses |
(7,977 | ) | (9,167 | ) | (391 | ) | ||||||
Total equity |
(£7,977 | ) | (£9,167 | ) | (£391 | ) |
Selected Statement of Cash Flows Data
Period Ended
May 6, |
Year Ended
December 31, |
|||||||||||
(in thousands) | ||||||||||||
2019 | 2018 | 2017 | ||||||||||
Net cash (used in)/ generated from operating activities |
(£4,621 | ) | £242 | (£2,959 | ) | |||||||
Net cash used in investing activities |
(50 | ) | (2,424 | ) | | |||||||
Net cash (used in)/ generated from financing activities |
(£123 | ) | £ | 5,981 | £ | 2,667 |
27
Comparative Historical and Unaudited Pro Forma Per Share Data
The following information does not give effect to the proposed reverse stock split described in Proposal No. 2 of this proxy statement/prospectus.
The information below reflects the historical net loss and book value per share of Spring Bank common stock and the historical net loss and book value per share of F-star common and preferred shares in comparison with the unaudited pro forma net loss and book value per share after giving effect to the Exchange on a pro forma basis. The pro forma amounts are presented for illustrative purposes only and are not necessarily indicative of what the financial position, results of operations or per share information of the company would have been if Spring Bank and F-star had effected the Exchange as of or for the periods presented.
You should read the information below in conjunction with the audited and unaudited consolidated financial statements of each of Spring Bank and F-star included in this proxy statement/prospectus and the related notes and the unaudited pro forma condensed combined financial information and notes related to such financial statements included elsewhere in this proxy statement/prospectus.
Six Months
Ended June 30, 2020 |
Year Ended
December 31, 2019 |
|||||||
Spring Bank Historical Per Common Share Data: |
||||||||
Basic and diluted net loss per share |
$ | (0.88 | ) | $ | (1.46 | ) | ||
Book value per share |
$ | 1.35 | $ | 2.15 | ||||
F-star Historical Per Common Share Data: |
||||||||
Basic and diluted net loss per share |
£ | (0.64 | ) | £ | (2.37 | ) | ||
Book value per share |
£ | 1.15 | £ | 2.08 | ||||
F-star and Spring Bank Combined Unaudited Pro Forma Data: |
||||||||
Basic and diluted net loss per share |
$ | (0.62 | ) | $ | (1.32 | ) | ||
Book value per share |
$ | 1.36 |
28
MARKET PRICE AND DIVIDEND INFORMATION
Spring Bank common stock is listed on the Nasdaq Capital Market under the symbol SBPH. F-star is a private company and shares of F-star common stock and F-star preferred stock are not publicly traded. The closing price of Spring Bank common stock on July 29, 2020, the last trading day prior to the public announcement of the Exchange, was $2.08 per share, and the closing price of Spring Bank common stock was $ on , 2020, each as reported on the Nasdaq Capital Market. These closing sale prices are not necessarily indicative of the price at which the common stock of the combined company will trade after the Closing. Because the market price of Spring Bank common stock is subject to fluctuation, the market value of the shares of Spring Bank common stock that F-star shareholders will be entitled to receive in the Exchange may increase or decrease.
Assuming approval of Proposal Nos. 1, 2, and 3 and successful application for initial listing on the Nasdaq Capital Market, following the consummation of the Exchange, the Spring Bank common stock will be listed on the Nasdaq Capital Market and will trade under the symbol FSTX.
As of , 2020, the Record Date for the Special meeting, there were approximately holders of record of Spring Bank common stock. As of , 2020, F-star had holders of record of F-star common stock and holders of record of F-star preferred stock. For detailed information regarding the beneficial ownership of certain Spring Bank stockholders upon consummation of the Exchange, see the section titled Principal Stockholders of the Combined Company in this proxy statement/prospectus.
Dividends
Spring Bank has never declared or paid any cash dividends on the Spring Bank common stock and does not anticipate paying cash dividends on the Spring Bank common stock for the foreseeable future.
Notwithstanding the foregoing, any determination to pay cash dividends subsequent to the Exchange will be at the discretion of the combined companys then-current board of directors and will depend upon a number of factors, including the combined companys results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors the then-current board of directors deems relevant.
29
The combined company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus, you should carefully consider the material risks described below and those described in the section of this proxy statement/prospectus titled Forward-Looking Statements before deciding how to vote your shares of stock. In addition, you should read and consider the risks associated with the business of Spring Bank because these risks may also affect the combined companythese risks can be found in Spring Banks Annual Report on Form 10-K, as updated by subsequent Quarterly Reports on Form 10-Q, all of which are filed with the SEC and incorporated by reference into this proxy statement/prospectus. You should also read and consider the other information in this proxy statement/prospectus and the other documents incorporated by reference into this proxy statement/prospectus. See the section titled Where You Can Find More Information in this proxy statement/prospectus.
Risks Related to the Exchange
The Exchange Ratio set forth in the Exchange Agreement is not adjustable based on the market price of Spring Bank common stock, so the Exchange consideration at the Closing may have a greater or lesser value than at the time the Exchange Agreement was signed. As described in the Exchange Agreement, the Exchange Ratio may be adjusted depending on Spring Banks net cash at Closing, the timing of Closing, the amount of gross proceeds received in the Pre-Closing Financing and the pre-money valuation attributed to F-star in the Pre-Closing Financing such that the Spring Bank security holders and F-star securityholders may own more or less of the combined company that presented in this proxy statement/prospectus.
At the Closing, the issued and outstanding share capital of F-star will be sold to Spring Bank in exchange for shares of Spring Bank common stock based on the Exchange Ratio. The Exchange Ratio may be adjusted (i) to the extent that Spring Banks expected net cash as of Closing is less than $15.0 million or greater than $17.0 million, (ii) to the extent that F-star does not raise at least $25.0 million in the Pre-Closing Financing at a pre-money valuation, or the valuation of F-star prior to receiving any proceeds from the Pre-Closing Financing, of at least $35.0 million, and (iii) to account for the actual proceeds raised in the Pre-Closing Financing. As of , 2020, F-star had received commitments from investors to purchase $ million of ordinary shares of F-star in the Pre-Closing Financing. Should the Closing occur after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. The assumed valuations and Exchange Ratio are likely to change, and the parties currently expect the Closing to occur during the fourth quarter of 2020. These and other adjustments to the Exchange Ratio are described further in this proxy statement/prospectus under the section titled The Exchange Agreement Transaction Consideration and Adjustment and the Exchange Agreement. Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the Spring Banks securityholders and the holders of F-stars share capital are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company. However, the Exchange Ratio will be adjusted based on the amount of Spring Bank net cash at Closing, the timing of Closing, the actual ratio of the Reverse Stock Split, amounts raised in the Pre-Closing Financing and as further set forth in the Exchange Agreement. The final Exchange Ratio may vary from the estimated Exchange Ratio presented in this proxy statement/information such that the holders of F-star share capital and Spring Bank securityholders may own more or less of the combined company than estimated in this proxy statement/information statement.
For purposes of the Exchange Agreement, Spring Banks net cash at closing is subject to certain reductions, including, without limitation, accounts payable, accrued expenses, current liabilities payable in cash, unpaid expenses related to the Exchange and certain other unpaid obligations, including outstanding lease obligations. In the event the amount of Spring Banks cash is smaller or such reductions are greater than anticipated, Spring Banks securityholders could hold a significantly smaller portion of the combined company.
30
Any changes in the market price of Spring Bank common stock before the completion of the Exchange will not affect the number of shares of Spring Bank common stock issuable to the F-star securityholders pursuant to the Exchange Agreement. Therefore, if before the completion of the Exchange, the market price of Spring Bank common stock declines from the market price on the date of the Exchange Agreement, then the F-star securityholders could receive Exchange consideration with substantially lower value than the value of the Exchange consideration on the date of the Exchange Agreement. Similarly, if before the completion of the Exchange, the market price of Spring Bank common stock increases from the market price of Spring Bank common stock on the date of the Exchange Agreement, then F-stars securityholders could receive Exchange consideration with substantially greater value than the value of the Exchange consideration on the date of the Exchange Agreement. Because the Exchange Ratio does not adjust as a result of changes in the market price of Spring Bank common stock, for each one percentage point change in the market price of Spring Bank common stock, there is a corresponding one percentage point rise or decline, respectively, in the value of the total Exchange consideration payable to the F-star securityholders pursuant to the Exchange Agreement.
F-star may not obtain sufficient funding in the Pre-Closing Financing and may require additional financing.
Immediately following the Closing and assuming an Exchange Ratio of 0.5338, the Spring Bank securityholders and holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion and Pre-Closing Financing) are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company. This percentage of ownership assumes that Spring Banks valuation will not be adjusted as a result of the expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing. F-star expects to raise at least $25.0 million in the Pre-Closing Financing, but it cannot guarantee that it will be able to do so. In the event that F-star raises less than $25.0 million in the Pre-Closing Financing, the anticipated percentage of ownership of the combined company by holders of share capital of F-star may be less than presently estimated. If either or both of Spring Bank or F-star hold less cash at the time of the Closing than the parties currently expect, or F-star raises less in the Pre-Closing Financing than anticipated, the combined company will need to raise additional capital sooner than currentlyexpected to fund its planned operations.
Spring Bank stockholders may not receive any payment on the CVRs and the CVRs may otherwise expire valueless.
Pursuant to the Exchange Agreement and the CVR Agreements, each share of Spring Bank common stock held by Spring Bank stockholders as of a record date immediately prior to the Closing will receive a dividend of (i) one contingent value right entitling these holders to receive payments in connection with certain transactions involving Spring Banks proprietary STING agonist compound (the STING Agonist CVR), and (ii) one contingent value right entitling these holders to receive payments in connection with the execution of a potential development agreement and certain other transactions involving Spring Banks proprietary STING antagonist compound (the STING Antagonist CVR and, together with the STING Agonist CVR, the CVRs).
The right of Spring Bank stockholders to receive any future payment on or to derive any value from the CVRs will be contingent solely upon the achievement of the events specified in the CVR Agreements within the time periods specified in the CVR Agreements and the consideration received being greater than any amounts permitted to be retained or deducted by Spring Bank under the CVR Agreements. The combined company may not be able to successfully achieve the development of Spring Banks Agonist or Antagonist compounds in a manner or within a time period that would generate payment pursuant to the CVR Agreements. If these payment triggering events are not achieved for any reason within the time periods specified in the CVR Agreements or the consideration received for these events is not greater than the amounts permitted to be retained or deducted by Spring Bank, no payments will be made under the CVRs, and the CVRs will expire valueless.
Furthermore, the CVRs will be unsecured obligations of the combined company and all payments under the CVRs, all other obligations under the CVR Agreement and the CVRs and any rights or other related claims will be subordinated in right of payment to the prior payment in full of all current or future senior obligations of the combined company. Finally, the U.S. federal income tax treatment of the CVRs is unclear. There is no legal authority directly addressing the U.S. federal income tax treatment of the receipt of, and payments on, the CVRs,
31
and there can be no assurance that the Internal Revenue Service would not assert, or that a court would not sustain, a position that could result in adverse U.S. federal income tax consequences to holders of the CVRs. Please review the information in the section titled Agreements Related to the Share ExchangeMaterial U.S. Federal Income Tax Consequences of the Receipt of CVRs to U.S. Holders for a more complete description of the material U.S. federal income tax consequences of the receipt of, and payments on, the CVRs.
The U.S. federal income tax treatment of the CVRs is unclear.
The U.S. federal income tax treatment of the CVRs is subject to substantial uncertainty. There is no legal authority directly addressing the U.S. federal income tax treatment of the receipt of, and payments under, the CVRs, and there can be no assurance that the IRS would not assert, or that a court would not sustain, a position that could potentially result in adverse U.S. federal income tax consequences to holders of the CVRs.
In particular, as discussed in the section titled Agreements Related to the ExchangeContingent Value Rights AgreementsMaterial U.S. Federal Income Tax Consequences of the CVRs to U.S. Holders, absent a change in law requiring otherwise, Spring Bank intends to take the position that the fair market value of the CVRs cannot be reasonably ascertained on the date of the issuance of the CVRs and, accordingly, the issuance of the CVRs constitutes an open transaction. Therefore, absent a change in law requiring otherwise, for U.S. federal income tax purposes, Spring Bank will not report the issuance of the CVRs as a current distribution of property with respect to its common stock and will instead report each future cash payment (if any) on the CVRs as a distribution with respect to Spring Banks common stock in the year in which such payment is made. It is possible that the IRS could assert that the issuance of the CVRs is not an open transaction and that the Spring Bank stockholders are treated as having received a distribution of property equal to the fair market value of the CVRs on the date the CVRs are distributed, which could be taxable to Spring Bank stockholders without the corresponding receipt of cash. In addition, it is possible that the IRS or a court could determine that the issuance of the CVRs (and/or any payments thereon) and the reverse stock split constitute a single recapitalization for U.S. federal income tax purposes with the CVRs constituting taxable boot received in such recapitalization exchange. In such case, the tax consequences of the CVRs and the Reverse Stock Split would differ from those described in this proxy statement/prospectus, including with respect to the timing and character of income.
Failure to complete the Exchange may result in either Spring Bank or F-star paying a termination fee to the other party and could significantly harm the market price of Spring Bank common stock and negatively affect the future business and operations of each company.
If the Exchange is not completed and the Exchange Agreement is terminated under certain circumstances, the terminating party may be required to pay the other party a termination fee of $2.0 million. In addition, under certain conditions, Spring Bank may be required to reimburse F-star for up to $750,000 of F-stars out-of-pocket expenses. Even if a termination fee or expenses of the other party are not payable in connection with a termination of the Exchange Agreement, each of Spring Bank and F-star have incurred significant fees and expenses, which must be paid whether or not the Exchange is completed. Further, if the Exchange is not completed, it could significantly harm the market price of Spring Bank common stock.
In addition, if the Exchange Agreement is terminated and the Spring Bank Board of Directors (the Spring Bank Board) or the F-star Board of Directors determines to seek another business combination or strategic transaction, there can be no assurance that either Spring Bank or F-star will be able to find a partner and close an alternative transaction on terms that are as favorable or more favorable than the terms set forth in the Exchange Agreement.
The issuance of Spring Bank common stock in the Exchange pursuant to the Exchange Agreement, the resulting change in control from the Exchange, the Reverse Stock Split and the Spring Bank Name Change must be approved by Spring Bank stockholders. Failure to obtain these approvals and failure of any other closing conditions to the Exchange Agreement would prevent the Closing and Exchange.
Before the Exchange can be completed, the Spring Bank stockholders must approve the issuance of Spring Bank common stock in the Exchange. Failure to obtain the required stockholder approval may result in a material delay in, or the abandonment of, the Exchange. Even if these matters are approved by the Spring Bank stockholders, certain other specified conditions set forth in the Exchange Agreement must be satisfied or waived
32
to complete the Exchange. Spring Bank and F-star cannot assure you that all of the conditions will be satisfied or waived. If the conditions are not satisfied or waived, the Exchange will not occur or will be delayed, and Spring Bank or F-star each may lose some or all of the intended benefits of the Exchange. Any delay in completing the Exchange may materially adversely affect the timing and benefits that are expected to be achieved from the Exchange.
The Exchange may be completed even though certain events occur prior to the Closing that materially and adversely affect Spring Bank or F-star.
The Exchange Agreement provides that either Spring Bank or F-star can refuse to complete the Exchange if there is a material adverse change affecting the other party between the date of the Exchange Agreement and the Closing. However, certain types of changes do not permit either party to refuse to complete the Exchange, even if this change could have a material adverse effect on Spring Bank or F-star, including:
|
general business or economic conditions affecting the industries in which Spring Bank or F-star, as applicable, operates and general conditions in financial markets to the extent these general conditions do not disproportionately affect Spring Bank and F-star, respectively; |
|
with respect to Spring Bank, any change in its stock price or trading volume excluding any underlying effect that may have caused such change, unless this effect is otherwise exempt from causing a material adverse effect under the Exchange Agreement; |
|
failure to meet internal or analysts expectations or projections for results of operations; |
|
failure to meet expectations regarding, or changes in expectations regarding, clinical trial program or study progress and, subject to certain exceptions, the occurrence of adverse events or serious adverse events in a clinical trial program; |
|
any effect resulting from the performance of obligations under the Exchange Agreement or the announcement of the Exchange or any related transactions; |
|
natural disasters, acts of terrorism, sabotage, military action or war or any escalation or worsening of military actions or wars, or any viruses, pandemics, epidemic or other outbreaks of illness or public health events, or any spread or worsening of these events (including worsening of the COVID-19 (as defined below) pandemic), or any other circumstance that may be considered a force majeure event; |
|
certain changes in, or any compliance with or action taken for the purpose of complying with, applicable laws or generally accepted accounting principles in the United States (U.S. GAAP), International Financial Reporting Standards or related interpretations provided these matters do not disproportionately affect Spring Bank or F-star, respectively; |
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actions taken by Spring Bank as reasonably necessary to comply with the Exchange Agreement or as otherwise permitted by the Exchange Agreement; |
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a government authoritys rejection or non-acceptance of intellectual property filings and applications; |
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regulatory action or the announcement of regulatory action regarding potentially competitive products or product candidates; and |
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stockholder litigation arising from or relating to the Exchange Agreement or the Exchange. |
If adverse changes occur and Spring Bank and F-star still complete the Exchange, the market price of the combined companys common stock may suffer. This in turn may reduce the value of the Exchange to the stockholders of Spring Bank, F-star or both.
Some Spring Bank and F-star officers and directors have interests in the Exchange that are different from the respective stockholders of Spring Bank and F-star and that may influence them to support or approve the Exchange without regard to the interests of the respective stockholders of Spring Bank or F-star.
Certain officers and directors of Spring Bank and F-star participate in arrangements that provide them with interests in the Exchange that are different from the interests of the respective stockholders of Spring Bank and F-star. For example, certain members of the Spring Bank Board and executive officers of Spring Bank have
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interests in the Exchange that may be different from, or in addition to, the interests of the Spring Bank stockholders. These interests relate to or arise from, among other things, (i) severance payments to which certain of Spring Banks executive officers will be entitled following completion of the Exchange as a result of termination of employment under certain circumstances, (ii) the accelerated vesting of certain of the equity awards held by Spring Banks executive officers and directors in connection with the completion of the Exchange, and (iii) the fact that certain current directors of Spring Bank, will continue as directors of the combined company after the Closing, each of which could influence them to support the Exchange.
Spring Bank and F-star securityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the Closing as compared to their current ownership and voting interest in the respective companies.
If the proposed Exchange is completed, the current securityholders of Spring Bank and F-star will own a smaller percentage of the combined company than their ownership in their respective companies prior to the Exchange. The issuance of shares of Spring Bank common stock to securityholders of F-star in the Exchange will reduce significantly the relative voting power of each share of Spring Bank common stock held by its current stockholders and will reduce the relative voting power of each share of F-star share capital held by current F-star securityholders. Consequently, Spring Bank stockholders as a group and the F-star securityholders as a group will have less influence over the management and policies of the combined company after the Exchange than prior to the Exchange.
In addition, the eight member board of directors of the combined company will initially include three individuals designated by Spring Bank and five individual designated by F-star. Consequently, securityholders of Spring Bank and F-star will be able to exercise less influence over the management and policies of the combined company following the Closing than they currently exercise over the management and policies of their respective companies.
Spring Bank stockholders and F-star securityholders may not realize a benefit from the Exchange commensurate with the ownership dilution they will experience in connection with the Exchange.
If the combined company is unable to realize the strategic and financial benefits currently anticipated from the Exchange, Spring Bank stockholders and F-star securityholders will have experienced substantial dilution of their ownership interests in their respective companies without receiving the expected commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the expected strategic and financial benefits currently anticipated from the Exchange.
During the pendency of the Exchange, Spring Bank and F-star may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Exchange Agreement, which could adversely affect their respective businesses.
Subject to certain limited exceptions, covenants in the Exchange Agreement impede the ability of Spring Bank and F-star to make acquisitions or to complete other transactions that are not in the ordinary course of business pending completion of the Exchange. As a result, if the Exchange is not completed, the parties may be at a disadvantage to their competitors during this period. In addition, while the Exchange Agreement is in effect, each party is generally prohibited from soliciting, initiating, encouraging or entering into certain extraordinary transactions, such as a merger, sale of assets, or other business combination outside the ordinary course of business with any third party, subject to certain exceptions relating to fiduciary duties. These transactions could be favorable to Spring Banks or F-stars securityholders.
The pendency of the Exchange could have an adverse effect on the trading price of Spring Bank common stock and its business, financial condition and prospects.
The pendency of the Exchange could disrupt Spring Banks business in many ways, including:
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the attention of its management and employees may be directed toward the completion of the Exchange and related matters and may be diverted from Spring Banks day-to-day business operations; and |
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third parties may seek to terminate or renegotiate their relationships with Spring Bank as a result of the Exchange, whether pursuant to the terms of their existing agreements with Spring Bank or otherwise. |
Should they occur, any of these matters could adversely affect the trading price of Spring Bank common stock or harm Spring Banks business, financial condition and prospects.
The lack of a public market for F- star shares makes it difficult to evaluate the value of F-star share capital. The F-star securityholders may receive shares of Spring Bank common stock in the Exchange that have a value that is less than, or greater than, the fair market value of the F-star share capital.
The outstanding share capital of F-star is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of F-star. Because the percentage of Spring Bank common stock to be issued to F-star securityholders was determined based on negotiations between the parties, it is possible that the value of Spring Bank common stock to be received by F-star securityholders will be less than the fair market value of F-star, or Spring Bank may pay more than the aggregate fair market value for F-star.
Spring Bank is substantially dependent on its employees to facilitate the consummation of the Exchange.
Spring Banks ability to successfully complete the Exchange depends in large part on its ability to retain certain personnel. Despite Spring Banks efforts to retain these employees, one or more may terminate their employment with Spring Bank on short notice. The loss of the services of certain employees could potentially harm Spring Banks ability to consummate the Exchange, to run its day-to-day business operations, as well as to fulfill its reporting obligations as a public company.
Litigation relating to the Exchange could require Spring Bank or F-star to incur significant costs and suffer management distraction, and could delay or enjoin the Exchange.
As described in the section Spring Bank BusinessLegal Proceedings, certain Spring Bank stockholders have filed complaints against Spring Bank, members of the Spring Bank Board and/or F-star relating to the Exchange and the registration statement filed in connection therewith. Spring Bank and F-star could be subject to additional demands or litigation related to the Exchange, whether or not the Exchange is consummated. While each of the defendants intends to vigorously defend themselves against these actions and believe these actions are without merit, there can be no assurance that any defendant, including Spring Bank and F-star, will be successful. The currently filed actions and any future actions may create uncertainty relating to the Exchange, or delay or enjoin the Exchange, result in substantial costs to Spring Bank or F-star and divert management time and resources.
Risks Related to the Proposed Reverse Stock Split
The proposed Reverse Stock Split may not increase the combined companys stock price over the long-term.
One of the purposes of the proposed Reverse Stock Split is to increase the per-share market price of the Spring Bank common stock. It cannot be assured, however, that the proposed Reverse Stock Split will accomplish this objective for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of Spring Bank common stock will proportionally increase the market price of Spring Bank common stock, it cannot be assured that the proposed Reverse Stock Split will increase the market price of Spring Bank common stock by a multiple of the proposed Reverse Stock Split ratio, or result in any permanent or sustained increase in the market price of Spring Bank common stock, which is dependent upon many factors, including the combined companys business and financial performance, general market conditions and prospects for future success. Thus, while the stock price of the combined company might meet the listing requirements for the Nasdaq Capital Market initially, it cannot be assured that it will continue to do so.
The proposed Reverse Stock Split may decrease the liquidity of the combined companys common stock.
The liquidity of the combined companys common stock could be adversely affected by the reduced number of shares outstanding after the proposed Reverse Stock Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for Spring Bank common stock.
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The proposed Reverse Stock Split may lead to a decrease in the combined companys overall market capitalization.
Should the market price of the combined companys common stock decline after the proposed Reverse Stock Split, the percentage decline may be greater, due to the lesser number of shares outstanding, than it would have been prior to the proposed Reverse Stock Split. A reverse stock split may be viewed negatively by the market and, consequently, can lead to a decrease in the combined companys overall market capitalization. If the per share market price does not increase in proportion to the proposed Reverse Stock Split ratio, then the value of the combined company, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of Spring Bank common stock will remain the same after the proposed Reverse Stock Split is effected, or that the proposed Reverse Stock Split will not have an adverse effect on the stock price of Spring Bank common stock due to the reduced number of shares outstanding after the proposed Reverse Stock Split.
Risks Related to the Combined Company
The market price of the combined companys common stock following the Exchange may decline as a result of the Exchange.
The market price of the combined companys common stock may decline as a result of the Exchange for a number of reasons, including if:
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investors react negatively to the Exchange, Spring Banks reasons for the Exchange or the prospects of the combined companys product candidates, business and financial condition following the Exchange; |
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the effect of the Exchange on the combined companys business and prospects is not consistent with the expectations of financial or industry analysts; or |
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the combined company does not achieve the perceived benefits of the Exchange as rapidly or to the extent anticipated by financial or industry analysts. |
The combined companys stock price is expected to be volatile, and the market price of its common stock may drop following the Exchange.
The market price of the combined companys common stock following the Exchange could be subject to significant fluctuations following the Exchange. Market prices for securities of early-stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile. Some of the factors that may cause the market price of the combined companys common stock to fluctuate include:
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any delay in the commencement, enrollment and ultimate completion of clinical trials; |
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results of clinical trials of existing and future product candidates, or those of the combined companys competitors; |
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variations in the combined companys financial results or those of companies that are perceived to be similar to the combined company; |
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regulatory or legal developments in the United States or other countries; |
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inability to obtain adequate product supply for any approved drug, or the inability to do so at acceptable prices; |
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the success of competitive therapies; |
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market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts reports or recommendations; |
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announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by the combined company or the combined companys competitors; |
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significant lawsuits, including patent or stockholder litigation; |
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additions or departures of key scientific or management personnel; |
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general economic, industry and market conditions; and |
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failure to maintain compliance with the continued listing requirements of The Nasdaq Capital Market. |
Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the combined companys common stock. In the past, following periods of volatility in the market price of a companys securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm the combined companys profitability and reputation.
The combined company will need to raise additional capital by issuing securities or debt or through licensing or other strategic arrangements, which may cause dilution to the combined companys stockholders or restrict the combined companys operations or impact its proprietary rights.
If either or both of Spring Bank or F-star hold less cash at the time of the Closing than the parties currently expect, the combined company will need to raise additional capital sooner than expected. The combined company will also generally need to raise substantial additional capital to support its planned operations. Additional financing may not be available to the combined company when it needs it or may not be available on favorable terms. In addition, the combined companys ability to obtain future funding when needed may be particularly challenging in light of the uncertainties and circumstances regarding the COVID-19 pandemic. To the extent that the combined company raises additional capital by issuing equity securities, this issuance may cause significant dilution to the combined companys stockholders ownership. The terms of any new equity securities may have preferences over the combined companys common stock. Any debt financing the combined company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the combined companys assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises additional funds through licensing, partnering or other strategic arrangements, it may be necessary to relinquish rights to some of the combined companys technologies or product candidates and proprietary rights, or grant licenses on terms that are not favorable to the combined company.
Following the Exchange, the combined company may be unable to integrate successfully the businesses of Spring Bank and F-star and realize the anticipated benefits of the Exchange.
The Exchange involves the combination of two companies which currently operate as independent companies. Following the Exchange, the combined company will be required to devote management attention and resources to integrating its business practices and operations. The combined company may fail to realize some or all of the anticipated benefits of the Exchange if the integration process takes longer than expected or is more costly than expected. Potential difficulties the combined company may encounter in the integration process include the following:
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complexities associated with managing the combined businesses; |
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integrating personnel from the two companies; |
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creation of uniform standards, controls, procedures, policies and information systems; |
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potential unknown liabilities and unforeseen increased expenses, delays or regulatory conditions associated with the Exchange; and |
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performance shortfalls at one or both of the companies as a result of the diversion of managements attention caused by completing the Exchange and integrating the companies operations. |
In addition, Spring Bank and F-star have operated and, until the completion of the Exchange, will continue to operate, independently. It is possible that the integration process also could result in the diversion of the combined companys managements attention, the disruption or interruption of, or the loss of momentum in, each companys ongoing businesses or inconsistencies in standards, controls, procedures and policies, any of which could adversely affect the combined companys ability to maintain relationships with customers, suppliers and employees or the ability to achieve the anticipated benefits of the Exchange, or could otherwise adversely affect the business and financial results of the combined company.
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If the assets subject to the CVR Agreements are not disposed of in a timely manner, the combined company may have to incur time and resources to wind down or dispose of such assets.
In connection with the Exchange, Spring Bank stockholders will receive two separate CVRs for each outstanding share of Spring Bank common stock held by such stockholder immediately prior to the Closing, each representing the non-transferable contractual right to receive certain contingent payments from the combined company upon the occurrence of certain events within agreed time periods relating to the disposition by the combined company of certain STING pathway assets of Spring Bank. See the section titled Agreements Related to the ExchangeContingent Value Rights Agreements included in this proxy statement/prospectus. Pursuant to the terms of the CVR Agreements, the holders of Spring Bank common stock prior to the closing, rather than the holders of the combined companys common stock, are the primary recipients of any net proceeds of the disposition of the assets subject to the CVR Agreements. Absent such CVR Agreements, the combined company could have allocated such funds, time and resources to its core programs and the foregoing could be a distraction to the combined companys management and employees. As a result, the combined companys operations and financial condition may be adversely affected.
The combined company will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
The combined company will incur significant legal, accounting and other expenses that F-star did not incur as a private company, including costs associated with public company reporting requirements. The combined company will also incur costs associated with corporate governance requirements, including requirements under the Sarbanes-Oxley Act, as well as rules implemented by the SEC and Nasdaq. These rules and regulations are expected to increase the combined companys legal and financial compliance costs and to make some activities more time consuming and costly. For example, the combined companys management team will consist of certain executive officers of F-star prior to the Exchange. These executive officers and other personnel will need to devote substantial time regarding operations as a public company and compliance with applicable laws and regulations. These rules and regulations may also make it difficult and expensive for the combined company to obtain directors and officers liability insurance. As a result, it may be more difficult for the combined company to attract and retain qualified individuals to serve on the combined companys board of directors or as executive officers of the combined company, which may adversely affect investor confidence in the combined company and could cause the combined companys business or stock price to suffer.
If securities or industry analysts do not publish research or reports about the combined companys business, or if they issue an adverse or misleading opinion regarding the combined companys stock, the combined companys stock price and trading volume could decline.
The trading market for the combined companys common stock may be influenced by the research and reports that industry or securities analysts publish about the combined companys business. If any of the analysts who cover the combined company issue an adverse or misleading opinion regarding the combined company, the combined companys business model, intellectual property or stock performance, or if the combined companys preclinical studies or clinical trials and operating results fail to meet the expectations of analysts, the combined companys stock price would likely decline. If one or more of these analysts cease coverage of the combined company or fail to publish reports on the combined company regularly, the combined company could lose visibility in the financial markets, which in turn could cause the combined companys stock price or trading volume to decline.
Spring Bank and F-star do not anticipate that the combined company will pay any cash dividends in the foreseeable future.
The current expectation is that the combined company will retain its future earnings to fund the development and growth of the combined companys business. As a result, capital appreciation, if any, of the common stock of the combined organization will be your sole source of gain, if any, for the foreseeable future.
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The pro forma financial statements included in this proxy statement/prospectus are presented for illustrative purposes only and may not be an indication of the combined organizations financial condition or results of operations following the completion of the Exchange.
The pro forma financial statements contained in this proxy statement/prospectus are presented for illustrative purposes only and may not be an indication of the combined companys financial condition or results of operations following the Exchange for several reasons. The pro forma financial statements have been derived from the historical financial statements of Spring Bank and F-star and certain adjustments and assumptions have been made regarding the combined company after giving effect to the Exchange. The information upon which these adjustments and assumptions have been made is preliminary, and these kinds of adjustments and assumptions are difficult to make with accuracy. Moreover, the pro forma financial statements do not reflect all costs that are expected to be incurred by the combined company in connection with the Exchange. The actual financial condition of the combined company following the Exchange may not be consistent with, or evident from, these pro forma financial statements. The assumptions used in preparing the pro forma financial information may not prove to be accurate, and other factors may affect the combined organizations financial condition following the Exchange. For more information, see the section titled Unaudited Pro Forma Condensed Combined Financial Statements in this proxy statement/prospectus.
Because the Exchange will likely result in an ownership change under Section 382 of the Code for Spring Bank, Spring Banks pre-Exchange net operating loss (NOL) carryforwards and certain other tax attributes will potentially be subject to limitations.
As of December 31, 2019, Spring Bank had U.S. federal NOL carryforwards and state NOL carryforwards of $115.6 million and $116.5 million, respectively. If a corporation undergoes an ownership change within the meaning of Section 382 of the Code (Section 382), the corporations NOL carryforwards and certain other tax attributes arising before the ownership change are subject to limitations on use after the ownership change. In general, an ownership change occurs if there is a cumulative change in the corporations equity ownership by certain stockholders that exceeds fifty percentage points over a rolling three-year period. Similar rules may apply under state tax laws. The Exchange will likely result in an ownership change for Spring Bank and, accordingly, Spring Banks NOL carryforwards and certain other tax attributes will potentially be subject to limitations (or disallowance) on their use after the Exchange. Additional ownership changes in the future could potentially result in additional limitations on Spring Banks and the combined companys NOL carryforwards. Consequently, even if the combined company achieves profitability, it may not be able to utilize a material portion of the combined companys NOL carryforwards and other tax attributes, which could have a material adverse effect on cash flow and results of operations. For more information on limitations on NOL carryforwards and certain other tax attributes, see Risk FactorsRisks Related to Spring Banks Common StockSpring Banks ability to use Spring Banks net operating loss and credit carryforwards to offset future taxable income may be subject to certain limitations, below.
Risks Related to Spring Banks Financial Position and Capital Needs
If the Exchange is not completed, Spring Bank may not be able to otherwise source adequate liquidity to fund its operations, meet its obligations, and continue as a going concern.
While Spring Bank has entered into the Exchange Agreement with F-star, the Closing may be delayed or may not occur at all and there can be no assurance that the Exchange will deliver the anticipated benefits Spring Bank expects or enhance stockholder value. If the Exchange is not completed and the Exchange Agreement is terminated under certain circumstances, Spring Bank may be required to pay F-star a termination fee of $2.0 million. Even if a termination fee is not payable in connection with a termination of the Exchange Agreement, Spring Bank will have incurred significant fees and expenses, which must be paid whether or not the Exchange is completed.
Spring Bank does not expect to raise any additional funds prior to the completion of the Exchange. However, if for any reason the Exchange does not close, Spring Banks existing cash, cash equivalents and marketable securities as of June 30, 2020 would enable it to fund Spring Banks operating expenses and capital
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expenditure requirements for at least the next twelve months, excluding transaction costs associated with the Exchange (which Spring Bank expects to pay upon the Closing). If for any reason the Exchange does not close, Spring Bank will be required to obtain additional funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources in order to fund its operations. In addition, pursuant to the instructions to Form S-3, if Spring Bank files a new S-3 shelf registration statement, it would only have the ability to sell shares under such registration statement during any 12-month period in an amount less than or equal to one-third of the aggregate market value of its common stock held by non-affiliates, which is commonly referred to as Spring Banks public float. Adequate additional funding may not be available to it on acceptable terms or at all for a variety of reasons, including as a result of continuing uncertainty and volatility in the global capital markets as a result of the ongoing COVID-19 pandemic. Spring Banks failure to raise capital as and when needed would have a negative impact on Spring Banks financial condition and Spring Banks ability to pursue its business strategy, and Spring Bank may be forced to delay, reduce or eliminate Spring Banks research and development programs or any future commercialization efforts. Spring Bank does not have any committed external source of funds.
Spring Bank has based its expenditure estimates on assumptions that may prove to be wrong, and Spring Bank could deploy its available capital resources sooner than Spring Bank currently expects. Further, changing circumstances, some of which may be beyond Spring Banks control, could cause it to consume capital significantly faster than Spring Bank currently anticipates, and Spring Bank may need to seek additional funds sooner than planned. Spring Banks future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:
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initiation, progress, timing, costs and results of clinical trials of SB 11285; |
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initiation, progress, timing, costs and results of preclinical studies and clinical trials of Spring Banks STING antagonist candidates and any other product candidates Spring Bank may develop; |
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the number and characteristics of product candidates that Spring Bank discovers or in-license and develops; |
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the outcome, timing and cost of seeking regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that Spring Bank performs more studies than those Spring Bank currently expects; |
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the costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing other intellectual property rights; |
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subject to receipt of marketing approval, revenue, if any, received from commercial sales of SB 11285 and any other products; |
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the costs and timing of the implementation of commercial-scale manufacturing activities; |
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the costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which Spring Bank may receive regulatory approval; and |
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the costs of operating as a public company. |
Even if Spring Bank is able to secure additional capital to provide it with necessary financial resources to pursue other options, it may continue to operate its business or attempt to pursue another strategic transaction like the Exchange, sell or otherwise dispose of its assets, or dissolve or liquidate the company. Some of these alternatives would be costly and time-consuming and would likely require that Spring Bank obtain additional funding. Spring Bank can make no assurances that it would be able to obtain additional financing or find a partner and close an alternative transaction on terms that are as favorable, or more favorable, than the terms set forth in the Exchange Agreement or that any such alternative transaction would be possible or successful, if pursued. Even if Spring Bank is able to pursue these alternatives, the failure to complete the Exchange may result in negative publicity and/or a negative impression of Spring Bank in the investment community, could significantly harm the market price of Spring Bank common stock and may affect Spring Banks relationship with employees and other partners in the business community.
If the Spring Bank Board were to decide to dissolve and liquidate Spring Banks assets, Spring Bank would be required to wind down its clinical trials, pay all of its debts and contractual obligations, and to set aside certain
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reserves for potential future claims, and there can be no assurances as to the amount or timing of available cash left, if any, to distribute to stockholders after paying its debts and other obligations and setting aside funds for reserves. In addition, Spring Bank may be subject to litigation or other claims related to a dissolution and liquidation. If a dissolution and liquidation were pursued, the Spring Bank Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Spring Bank common stock would likely lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of Spring Bank.
Spring Bank has incurred significant losses since Spring Banks inception and anticipates that Spring Bank will incur significant and increasing losses in the future.
Spring Bank does not have any products approved by regulatory authorities for marketing and has not generated any revenue from product sales, and Spring Bank continues to incur significant research, development and other expenses related to Spring Banks ongoing operations. As a result, Spring Bank is not profitable and has incurred losses in every reporting period since Spring Banks inception. For the years ended December 31, 2019 and 2018, Spring Bank reported a net loss of $24.1 million and $22.8 million, respectively. Spring Banks net loss for the six months ended June 30, 2020 was $14.7 million, and Spring Bank had an accumulated deficit of $140.9 million at June 30, 2020.
Spring Bank expects to continue to incur significant and increasing losses for the foreseeable future. Spring Bank anticipates these losses to increase as its expenses increase, and, if Spring Bank does not complete the Exchange, Spring Bank expects that Spring Banks expenses will increase if and as Spring Bank:
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continues clinical development of SB 11285, Spring Banks lead STING agonist product candidate; |
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initiates and continues research and preclinical and clinical development efforts for Spring Banks other product candidates, including candidates from Spring Banks STING antagonist program; |
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seeks to identify and develop additional product candidates; |
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seeks regulatory and marketing approvals for Spring Banks product candidates that successfully complete clinical trials, if any; |
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establishes sales, marketing, distribution and other commercial infrastructure in the future to commercialize various products for which Spring Bank may obtain marketing approval, if any; |
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requires the manufacture and supply of larger quantities of product candidates for clinical development and potentially commercialization; |
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maintains, expands and protects Spring Banks intellectual property portfolio; and |
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adds operational, financial and management information systems and personnel, including personnel to support Spring Banks product development and help comply with Spring Banks obligations as a public company. |
Spring Bank intends to expend a significant amount of Spring Banks limited resources on the development of Spring Banks sole clinical stage product candidate, SB 11285, for treatment of selected cancers, and may fail to capitalize on other technologies, product candidates or other indications that may be more profitable or for which there is a greater likelihood of success.
Spring Bank is focusing a significant amount of Spring Banks resources on the development of SB 11285, which concentrates the risk of product failure on one product candidate. SB 11285 may prove to be unsafe or ineffective. Because of this concentration of resources, Spring Bank may forego or delay development of other technologies, product candidates or other indications that later prove to have greater commercial potential.
Until recently, Spring Banks sole clinical stage product candidate was inarigivir soproxil, an investigational orally-administered RIG-I agonist compound, as a potential treatment for chronic hepatitis B virus (HBV). However, in January 2020, Spring Bank announced the discontinuation of the development of inarigivir in the interest of patient safety based on the occurrence of unexpected serious adverse events in Spring Banks Phase 2b chronic HBV CATALYST 2 trial. As a result, Spring Bank has refocused Spring Banks clinical development
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efforts on SB 11285, which is at a much earlier stage of development than inarigivir was when Spring Banks development program for that product candidate was discontinued.
Spring Banks resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. Spring Banks spending on current and future research and development programs and product candidates may not yield any commercially viable products. If Spring Bank does not accurately evaluate the commercial potential or target market for a particular product candidate, Spring Bank may relinquish valuable rights to the candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for it to retain sole development and commercialization rights to the product candidate.
Risks Related to the Discovery, Development and Commercialization of Spring Banks Product Candidates
Spring Banks future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of SB 11285 and will require significant capital resources and years of additional clinical development effort. If Spring Bank is unable to develop, obtain regulatory approval for or successfully commercialize SB 11285 or experience significant delays in doing so, Spring Banks business could be materially harmed.
Spring Bank does not have any products that have gained regulatory approval. As a result, Spring Banks business is dependent on Spring Banks ability to successfully complete clinical development of, obtain regulatory approval for, and, if approved, to successfully commercialize SB 11285 in a timely manner. The success of SB 11285 will depend on several factors, including the following:
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successful completion of Spring Banks Phase 1a/1b clinical trial for SB 11285; |
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successful completion of additional studies to support additional clinical trials; |
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initiation and successful enrollment and completion of additional clinical trials; |
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safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority for marketing approval; |
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timely receipt of marketing approvals from applicable regulatory authorities; |
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the performance of Spring Banks collaborators; |
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establishment of supply arrangements with third-party raw materials suppliers and manufacturers; |
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establishment of arrangements with third-party manufacturers to obtain finished drug products that are appropriately packaged for sale; |
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obtaining and maintaining patent, trade secret protection and regulatory exclusivity, both in the United States and internationally; |
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protection of Spring Banks rights in Spring Banks intellectual property portfolio; |
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successful launch of commercial sales following any marketing approval; |
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a continued acceptable safety profile following any marketing approval; and |
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commercial acceptance by patients, the medical community and third-party payors following any marketing approval. |
Many of these factors are beyond Spring Banks control, including potential delays in its clinical trials as a result of the ongoing COVID-19 pandemic, the regulatory submission process, potential threats to Spring Banks intellectual property rights and the manufacturing, marketing and sales efforts of any collaborators. If Spring Bank is unable to develop, receive marketing approval for and successfully commercialize SB 11285 or experience delays because of any of these factors or otherwise, Spring Banks business could be substantially harmed.
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Business interruptions resulting from the COVID-19 pandemic or similar public health crises could cause a disruption of the development of Spring Banks product candidates and adversely impact Spring Banks business.
Public health crises such as pandemics or similar outbreaks could adversely impact Spring Banks business. In December 2019, the coronavirus, which causes COVID-19, surfaced in Wuhan, China and has become a global pandemic affecting most regions and countries, including Massachusetts where Spring Banks primary office and laboratory space is located. The COVID-19 pandemic is evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, shelter-in-place orders, travel restrictions and other public health safety measures, as well as reported adverse impacts on healthcare resources, facilities and providers, in Massachusetts, across the United States and in other countries. The COVID-19 pandemic has disrupted global supply chains, created global economic uncertainty and disrupted financial markets. The extent to which COVID-19 impacts Spring Banks operations or those of Spring Banks third-party partners will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, additional or modified government actions, new information that will emerge concerning the severity and impact of COVID-19 and the actions to contain COVID-19 or address its impact in the short and long term, among others.
Additionally, timely initiation and completion of preclinical activities and clinical trials is dependent upon the availability of, for example, preclinical and clinical trial sites, researchers and investigators, regulatory agency personnel, and materials, which may be adversely affected by global health matters, such as pandemics. Spring Bank plans to conduct preclinical activities and clinical trials for Spring Banks investigational drug product candidates in geographies which are currently being affected by COVID-19.
Further, in response to the pandemic and in accordance with direction from state and local government authorities, Spring Bank has restricted access to Spring Banks facilities mostly to personnel and third parties who must perform critical activities that must be completed on-site, limited the number of such personnel that can be present at Spring Banks facilities at any one time, and requested that most of Spring Banks personnel work remotely. In the event that governmental authorities were to further modify current restrictions, Spring Banks employees conducting research and development activities may not be able to access Spring Banks laboratory space, and Spring Banks core activities may be significantly limited or curtailed, possibly for an extended period of time.
Some factors from the COVID-19 pandemic that could delay or otherwise adversely affect the completion of Spring Banks preclinical activities and the planned initiation of Spring Banks clinical trials for Spring Banks investigational drug product candidates, including STING, as well as Spring Banks business generally, include:
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the potential diversion of healthcare resources away from the conduct of preclinical activities and clinical trials to focus on pandemic concerns, including the availability of necessary materials and the attention of physicians serving as Spring Banks clinical trial investigators, hospitals serving as Spring Banks clinical trial sites and hospital staff supporting the conduct of Spring Banks prospective clinical trials; |
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limitations on travel that could interrupt key preclinical activities and trial activities, such as clinical trial site initiations and monitoring, domestic and international travel by employees, contractors or patients to clinical trial sites, including any government-imposed travel restrictions or quarantines that will impact the ability or willingness of patients, employees or contractors to travel to Spring Banks research, manufacturing and clinical trial sites or secure visas or entry permissions, any of which could delay or adversely impact the conduct or progress of Spring Banks prospective clinical trials; |
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interruption or delays in the operations of the U.S. FDA and comparable foreign regulatory agencies, which may impact review, inspection, clearance and approval timelines; |
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interruption in global shipping affecting the transport of clinical trial materials, such as patient samples, investigational drug product candidates and conditioning drugs and other supplies used in Spring Banks prospective clinical trials; |
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interruption of, or delays in receiving, supplies of Spring Banks investigational drug product from Spring Banks contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery system; |
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limitations on Spring Banks business operations by local, state, or the federal government that could impact Spring Banks ability to conduct Spring Banks preclinical or clinical activities, including completing any IND-enabling studies or Spring Banks ability to select future development candidates; and |
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business disruptions caused by potential workplace, laboratory and office closures and an increased reliance on employees working from home, disruptions to or delays in ongoing laboratory experiments and operations, staffing shortages, travel limitations, cyber security and data accessibility, or communication or mass transit disruptions, any of which could adversely impact Spring Banks business operations or delay necessary interactions with local regulators, ethics committees, manufacturing sites, research or clinical trial sites and other important agencies and contractors. |
These and other factors arising from COVID-19 could worsen in countries that are already afflicted with the coronavirus or could continue to spread to additional countries, each of which could further adversely impact Spring Banks ability to conduct clinical trials and Spring Banks business generally, and could have a material adverse impact on Spring Banks operations and financial condition and results.
In addition, the trading prices for Spring Banks common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic. As a result, Spring Bank may face difficulties raising capital through sales of Spring Banks common stock or such sales may be on unfavorable terms. The COVID-19 outbreak continues to rapidly evolve. The extent to which the outbreak may impact Spring Banks business, preclinical studies and planned clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and other actions to contain the outbreak or address its impact, such as social distancing and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and address the disease.
The results of preclinical studies and clinical trials that Spring Bank has conducted to date may not be predictive of results in future clinical trials.
The outcome of preclinical studies and clinical trials that Spring Bank has conducted to date may not be predictive of the results of later clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials, even after seeing promising results in earlier preclinical studies and clinical trials. The results from Spring Banks in vitro and in vivo preclinical studies may not translate into human efficacy.
In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and other clinical trial protocols and the rate of dropout among clinical trial participants. If Spring Bank fails to receive positive results in clinical trials of SB 11285 or any of Spring Banks other product candidates, the development timeline and regulatory approval and commercialization prospects for such product candidate, and, correspondingly, Spring Banks business and financial prospects, would be negatively impacted.
Interim, top-line, and preliminary data from Spring Banks clinical trials that Spring Bank announces or publishes from time to time may change as more patient data become available or as additional analyses are conducted, and the data are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, Spring Bank may publicly disclose interim or top-line from Spring Banks clinical studies, which are based on a preliminary analysis of then-available efficacy, tolerability, pharmacokinetic and
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safety data. The results and related findings and conclusions Spring Bank may draw from this top-line data are subject to change following a more comprehensive review of the data related to the particular study or trial. Interim data from clinical trials that Spring Bank may complete is subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data Spring Bank previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Material adverse changes between preliminary, top-line, or interim data and final data could significantly harm Spring Banks business prospects.
The therapeutic efficacy of SB 11285 has not been definitively shown in humans, and Spring Bank may not be able to successfully develop and commercialize SB 11285 or any of Spring Banks other product candidates.
SB 11285 and Spring Banks other product candidates are novel compounds and their potential benefit as immunotherapies or immunomodulators, as applicable, has not been definitively shown in humans. SB 11285 and Spring Banks other product candidates may not prove to be effective against the indications for which they are being designed to act and may not demonstrate in future clinical trials any or all of the pharmacological effects that have been observed in preclinical studies or clinical trials to date.
SB 11285 and Spring Banks other product candidates may interact with human biological systems in unforeseen, ineffective or harmful ways. If any of Spring Banks product candidates is associated with undesirable side effects or have characteristics that are unexpected, Spring Bank may need to abandon the development of such product candidate or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Because of these and other risks described herein that are inherent in the development of novel therapeutic agents, Spring Bank may never successfully develop or commercialize SB 11285 or any of Spring Banks other product candidates, in which case Spring Banks business will be harmed.
Clinical development of product candidates involves a lengthy and expensive process. Additionally, there are substantial risks inherent in attempting to commercialize new drugs, and, as a result, Spring Bank may not be able to successfully develop products for commercial use.
Spring Bank may experience delays in Spring Banks ongoing or future preclinical or clinical trials and Spring Bank does not know whether planned clinical trials will begin or enroll subjects on a timely basis, need to be redesigned or be completed on schedule, if at all. Failure can occur at any time during the clinical trial process, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of adverse events that are severe or medically or commercially unacceptable, failure to comply with protocols or applicable regulatory requirements and determination by the FDA or any comparable foreign regulatory authority, such as the EMA, that a product candidate may not continue development or is not approvable. Additionally, because Spring Banks product candidates are based on new technologies and costs to treat patients with relapsed/refractory cancer may be significant, Spring Banks clinical trial costs are likely to be significantly higher than for more conventional therapeutic technologies or drug products.
There can be no assurance that the FDA or other foreign regulatory authorities will not put clinical trials of SB 11285 or any of Spring Banks other product candidates on clinical hold now or in the future. Clinical trials may be delayed, suspended or prematurely terminated or may take longer than anticipated for a variety of reasons, such as:
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delay or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a trial design that Spring Bank is able to execute; |
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delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial; |
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delay or failure in reaching agreement on acceptable terms with prospective clinical research organizations (CROs), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
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delay or failure in obtaining Investigational Review Board (IRB), approval or the approval of other reviewing entities, including comparable foreign regulatory authorities, to conduct a clinical trial at a site; |
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withdrawal of clinical trial sites from Spring Banks clinical trials as a result of changing standards of care or the ineligibility of a site to participate in Spring Banks clinical trials; |
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delay or failure in recruiting and enrolling suitable study subjects to participate in a trial; |
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delay or failure in study subjects completing a trial or returning for post-treatment follow-up or otherwise complying with the trial protocol; |
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clinical sites and investigators deviating from the trial protocol, failing to conduct the trial in accordance with regulatory requirements or dropping out of a trial; |
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inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for competing product candidates with the same indication; |
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failure of Spring Banks third-party service providers to satisfy their contractual duties or meet expected deadlines; |
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delay or failure in adding new clinical trial sites; |
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feedback from the FDA, the IRBs, data safety monitoring boards, or comparable foreign regulatory authorities, or results from earlier stage or concurrent preclinical studies and clinical trials, that might require modification of the protocol for the trial; |
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decision by the FDA, the IRBs, comparable foreign regulatory authorities, or Spring Bank, or recommendation by a data safety monitoring board or comparable foreign regulatory authority, to suspend or terminate clinical trials at any time for safety issues or for any other reason; |
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unacceptable risk-benefit profile, unforeseen safety issues or adverse side effects or adverse events; |
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failure of a product candidate to demonstrate any benefit; |
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difficulties in manufacturing or obtaining from third parties sufficient quantities of a product candidate for use in clinical trials; |
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lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional clinical studies or increased expenses associated with the services of Spring Banks CROs and other third parties; or |
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changes in governmental regulations or administrative actions. |
If Spring Bank experiences delays in any preclinical or clinical trial of Spring Banks product candidates, including as a result of the ongoing COVID-19 pandemic, the product candidate development and approval process could be slowed down, and as a result the costs of the development and approval process may increase, the commercial prospects of Spring Banks product candidates may be harmed, and Spring Banks ability to generate product revenues from these product candidates may be delayed. Significant preclinical or clinical trial delays also could shorten any periods during which Spring Bank may have the exclusive right to commercialize Spring Banks product candidates or allow Spring Banks competitors to bring products to market before Spring Bank does and impairs Spring Banks ability to commercialize Spring Banks product candidates successfully and may harm Spring Banks business and results of operations. In addition, many of the factors that lead to clinical trial delays may ultimately lead to the denial of marketing approval of any of Spring Banks product candidates.
If Spring Bank or Spring Banks collaborators experiences delays or difficulties in the enrollment of patients in clinical trials, Spring Banks receipt of necessary regulatory approvals could be delayed or prevented.
Spring Bank or Spring Banks collaborators may not be able to initiate or continue clinical trials for any of Spring Banks product candidates if Spring Bank or Spring Banks collaborators, as applicable, is unable to locate and enroll a sufficient number of eligible patients to participate in clinical trials as required by the FDA or
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comparable foreign regulatory authorities. Patient enrollment is a significant factor in the timing of clinical trials, and is affected by many factors, including the following events:
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the size and nature of the patient population; |
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the severity of the disease under investigation; |
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the proximity of patients to clinical sites; |
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the eligibility criteria for the trial; |
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the design of the clinical trial; |
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efforts to facilitate timely enrollment; |
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competing clinical trials; and |
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clinicians and patients perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications Spring Bank is investigating. |
Spring Banks inability to enroll a sufficient number of patients for Spring Banks clinical trials could result in significant delays or may require Spring Bank to abandon one or more clinical trials altogether. Enrollment delays in Spring Banks clinical trials may result in increased development costs for Spring Banks product candidates, delay or halt the development of and approval processes for Spring Banks product candidates and jeopardize Spring Banks ability to commence sales of and generate revenues from Spring Banks product candidates, which could cause the value of Spring Bank to decline.
SB 11285 or any other product candidate that Spring Bank develops may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval or limit the commercial profile of an approved label.
Undesirable side effects caused by SB 11285 or any other product candidate could cause Spring Bank or regulatory authorities to interrupt, delay or halt clinical trials and could result in a restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities.
Results of Spring Banks trials could reveal an unacceptably high severity and prevalence of side effects. In such an event, Spring Banks trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order Spring Bank to cease further development of or deny approval of Spring Banks product candidates for any or all targeted indications. Study drug-related side effects could affect study subject recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. If SB 11285 or any of Spring Banks other product candidates is associated with adverse events or undesirable side effects or has properties that are unexpected, Spring Bank may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. For instance, in January 2020, Spring Bank announced the discontinuation of the development of inarigivir in the interest of patient safety based on the occurrence of unexpected serious adverse events in Spring Banks Phase 2b CATALYST 2 trial. Many compounds that initially showed promise in clinical or earlier stage testing have later been found to cause undesirable or unexpected side effects that prevented further development of the compound. Spring Bank cannot provide any assurances that there will not be further treatment-related severe adverse events or deaths with other product candidates or that patient recruitment for trials with Spring Banks other product candidates will not be adversely impacted by the events with inarigivir, each of which could materially and adversely affect Spring Banks business and prospects.
Product liability lawsuits against Spring Bank could cause Spring Bank to incur substantial liabilities and to limit commercialization of SB 11285 or any other product candidates.
Spring Bank faces an inherent risk of product liability exposure related to the testing of Spring Banks current and former product candidates by Spring Bank or Spring Banks investigators in human clinical trials, including, but not limited to, Spring Bank determining to discontinue the development of inarigivir, an
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investigational RIG-I agonist compound, in the interest of patient safety based on the occurrence of unexpected serious adverse events in Spring Banks Phase 2b CATALYST 2 trial. Product liability claims may be brought against Spring Bank by study subjects enrolled in Spring Banks clinical trials, patients, healthcare providers or others using, administering or selling Spring Banks product candidates. If Spring Bank cannot successfully defend itself against claims that Spring Banks product candidates caused injuries, Spring Bank could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in, for example:
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decreased demand for SB 11285 or any of Spring Banks other product candidates; |
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the inability to commercialize SB 11285 or any of Spring Banks other product candidates; |
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termination of clinical trial sites or entire trial programs; |
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injury to Spring Banks reputation and significant negative media attention; |
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withdrawal of clinical trial subjects; |
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significant costs to defend the related litigation; |
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substantial monetary awards to clinical trial subjects or patients; |
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loss of revenue; |
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diversion of management and scientific resources from Spring Banks business operations; and |
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increased scrutiny and potential investigation by, among others, the FDA, the United States Department of Justice (DOJ), the Office of Inspector General of the Office of Health and Human Services (HHS), state attorneys general, members of Congress and the public. |
Spring Banks inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products Spring Bank develops, alone or with collaborators. Although Spring Bank currently carries clinical trial insurance, the amount of such insurance coverage may not be adequate, Spring Bank may be unable to maintain such insurance, or Spring Bank may not be able to obtain additional or replacement insurance at a reasonable cost, if at all. Spring Banks insurance policies may also have various exclusions, and Spring Bank may be subject to a product liability claim for which Spring Bank has no coverage. Spring Bank may have to pay any amounts awarded by a court or negotiated in a settlement that exceed Spring Banks coverage limitations or that are not covered by Spring Banks insurance, and Spring Bank may not have, or be able to obtain, sufficient capital to pay such amounts. Even if Spring Banks agreements with any future corporate collaborators entitle Spring Bank to indemnification against losses, such indemnification may not be available or adequate should any claim arise.
Risks Related to Spring Banks Dependence on Third Parties
Spring Bank relies on third parties to conduct Spring Banks preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or their relationship with Spring Bank is terminated, Spring Banks business may be harmed and Spring Banks drug development efforts could be delayed.
Spring Bank relies on third-party research vendors, academic research institutions, CROs, and other third parties to conduct and provide Spring Bank with significant data and other information related to Spring Banks projects, preclinical studies and clinical trials. Spring Bank relies on these parties for execution of Spring Banks preclinical studies and clinical trials, and Spring Bank controls only some aspects of their activities. If these third parties provide inaccurate, misleading, or incomplete data, Spring Banks business, prospects, and results of operations could be materially adversely affected. Nevertheless, Spring Bank is responsible for ensuring that each of Spring Banks preclinical studies and clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and Spring Banks reliance on the CROs does not relieve Spring Bank of Spring Banks regulatory responsibilities. Spring Bank also relies on third parties to assist in conducting Spring Banks preclinical studies in accordance with good laboratory practice (GLP), and the Animal Welfare Act requirements. Spring Bank and Spring Banks service providers are required to comply with federal regulations and good clinical practice (GCP), which are international standards meant to protect the rights and health of subjects that are enforced by the FDA, the Competent Authorities of the Member States of
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the European Economic Area and comparable foreign regulatory authorities. Regulatory authorities enforce GCP through periodic inspections of trial sponsors, principal investigators and trial sites. If Spring Bank or any of Spring Banks service providers fails to comply with applicable GCP, the clinical data generated in Spring Banks clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Spring Bank to perform additional clinical trials before approving Spring Banks marketing applications. Spring Bank cannot guarantee that upon inspection by a given regulatory authority, such regulatory authority will determine that any of Spring Banks clinical trials comply with GCP requirements. In addition, Spring Banks clinical trials must be conducted with product produced under current Good Manufacturing Practices (cGMPs). Failure to comply with these regulations may require Spring Bank to repeat preclinical studies and clinical trials, which would delay the regulatory approval process.
Spring Banks service providers are not Spring Banks employees, and except for remedies available to Spring Bank under Spring Banks agreements with such service providers, Spring Bank cannot control whether or not they devote sufficient time and resources to Spring Banks ongoing clinical, nonclinical and preclinical programs. If service providers do not successfully carry out their contractual duties or obligations or meet expected deadlines (including as a result of the COVID-19 pandemic) or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to Spring Banks protocols, regulatory requirements or for other reasons, Spring Banks preclinical studies and clinical trials may be extended, delayed or terminated and Spring Bank may not be able to obtain regulatory approval for or successfully commercialize SB 11285 or any of Spring Banks other product candidates. As a result, Spring Banks results of operations and the commercial prospects for Spring Banks product candidates would be harmed, Spring Banks costs could increase and Spring Banks ability to generate revenues could be delayed.
Because Spring Bank has relied and continue to rely on third parties, Spring Banks internal capacity to perform these functions is limited. Outsourcing these functions involves risk that third parties may not perform to Spring Banks standards, may not produce results in a timely manner or may fail to perform at all. In addition, the use of third-party service providers requires Spring Bank to disclose Spring Banks proprietary information to these parties, which could increase the risk that this information will be misappropriated. Spring Bank currently has a small number of employees, which limits the internal resources Spring Bank has available to identify and monitor Spring Banks third-party providers. To the extent Spring Bank is unable to identify and successfully manage the performance of third-party service providers in the future, Spring Banks business may be adversely affected. Though Spring Bank carefully manages Spring Banks relationships with Spring Banks service providers, there can be no assurance that Spring Bank will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on Spring Banks business, financial condition and prospects.
Spring Banks third-party vendors and service providers generally have the right to terminate their agreements with Spring Bank under certain circumstances. Identifying, qualifying and managing performance of third-party service providers can be difficult, time consuming and cause delays in Spring Banks development programs. In addition, there is a natural transition period when a new third-party vendor or service provider commences work, and the new third-party vendor or service provider may not provide the same type or level of services as the original provider. If any of Spring Banks relationships with Spring Banks third-party vendors or service providers terminate, Spring Bank may not be able to enter into arrangements with alternative third-party vendors or service providers or to do so on commercially reasonable terms.
Spring Bank has no experience manufacturing any product candidate on a commercial scale and have no manufacturing facility. Spring Bank is dependent on contract manufacturers for the manufacture of SB 11285 as well as on third parties for Spring Banks supply chain and expects to rely on contract manufacturers for any other product candidates. If Spring Bank experiences problems with any of these contract manufacturers, the manufacturing of SB 11285 or any other product candidate could be delayed.
Spring Bank currently has no manufacturing facilities and limited personnel with manufacturing experience. Spring Bank relies on contract manufacturers to produce both drug substance and drug product required for Spring Banks clinical trials. Spring Bank plans to continue to rely upon contract manufacturers to manufacture
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commercial quantities of Spring Banks products, if approved. Reliance on these third-party contractors entails risks, including:
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delays by Spring Banks third-party contract manufacturers to produce and deliver sufficient supply of clinical trial materials, including but not limited to delays or disruptions as a result of the ongoing COVID-19 pandemic and third-party contractors giving greater priority to the supply of other products over Spring Banks product candidates or otherwise not satisfactorily performing according to the terms of the agreements between Spring Bank and them; |
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the possible termination or nonrenewal of agreements by Spring Banks third-party contractors at a time that is costly or inconvenient for Spring Bank; |
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the possible breach by the third-party contractors of Spring Banks agreements with them; |
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the failure of third-party contractors to comply with applicable regulatory requirements; |
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the possible mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; |
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the possibility of clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and |
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the possible misappropriation of Spring Banks proprietary information, including Spring Banks trade secrets and know-how. |
Spring Bank currently relies, and expects to continue to rely, on a small number of third-party contract manufacturers to supply the majority of Spring Banks active pharmaceutical ingredient (API), and required finished product for Spring Banks preclinical studies and clinical trials. These contract manufacturers are typically single source suppliers to Spring Bank. Spring Bank does not have long-term agreements with any of these third parties. If any of Spring Banks existing manufacturers become unavailable to Spring Bank for any reason, Spring Bank may experience a delay in identifying or qualifying replacements.
If Spring Banks current supply of drug substance turns out to be insufficient to complete Spring Banks clinical trial for SB 11285 or Spring Bank is unable to obtain alternative sources of supply on favorable terms, on a timely basis or at all, Spring Banks business may be adversely affected.
Each of Spring Banks API and drug product manufacturers must comply with cGMPs and other stringent regulatory requirements enforced by the FDA and foreign regulatory authorities in other jurisdictions. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation, which occur in addition to Spring Banks own quality assurance releases. Manufacturers of Spring Banks products may be unable to comply with these GMP requirements and with other regulatory requirements. Spring Bank has little control over Spring Banks manufacturers or partners compliance with these regulations and standards.
Any manufacturing problem or the loss of a contract manufacturer could be disruptive to Spring Banks operations, delay Spring Banks clinical trials and, if any of Spring Banks products are approved for sale, result in lost sales. Spring Banks manufacturers may experience problems with their respective manufacturing and distribution operations and processes, including for example, quality issues, such as product specification and stability failures, procedural deviations, improper equipment installation or operation, utility failures, contamination and natural disasters. In addition, the raw materials necessary to make API for Spring Banks products are acquired from a limited number of sources. Any delay or disruption in the availability of these raw materials or a change in raw material suppliers could result in production disruptions, delays or higher costs with consequent adverse effects on Spring Bank. Any reliance on suppliers may involve additional risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability and quality. Any unanticipated disruption to future contract manufacture caused by problems at suppliers could delay shipment of Spring Banks product candidates, increase Spring Banks cost of goods sold or, if any of Spring Banks products are approved for sale, result in lost sales.
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If any of Spring Banks product candidates are approved by any regulatory agency, Spring Bank plans to enter into agreements with third-party contract manufacturers for the commercial production and distribution of those products. It may be difficult for Spring Bank to reach agreement with a contract manufacturer on satisfactory terms or in a timely manner. In addition, Spring Bank may face competition for access to manufacturing facilities, as there are a limited number of contract manufacturers operating under cGMPs that are capable of manufacturing Spring Banks product candidates. Consequently, Spring Bank may not be able to reach agreement with third-party manufacturers on satisfactory terms, which could delay Spring Banks commercialization efforts.
Third-party manufacturers are required to comply with cGMPs and similar regulatory requirements outside the United States. Facilities used by Spring Banks third-party manufacturers must be approved by the FDA after Spring Bank submits an NDA and before potential approval of the product candidate. Similar regulations apply to manufacturers of Spring Banks product candidates for use or sale in foreign countries. Spring Bank does not control the manufacturing process and is completely dependent on Spring Banks third-party manufacturers for compliance with the applicable regulatory requirements for the manufacture of Spring Banks product candidates. If Spring Banks manufacturers cannot successfully manufacture material that conforms to Spring Banks specifications or the strict regulatory requirements of the FDA and any applicable foreign regulatory authority, they will not be able to secure the applicable approval for their manufacturing facilities. If these facilities are not approved for commercial manufacture, Spring Bank may need to find alternative manufacturing facilities, which could result in delays in obtaining approval for the applicable product candidate.
In addition, Spring Banks manufacturers are subject to ongoing periodic inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements both prior to and following the receipt of marketing approval for any of Spring Banks product candidates. Some of these inspections may be unannounced. Failure by any of Spring Banks manufacturers to comply with applicable cGMPs or other regulatory requirements could result in sanctions being imposed on Spring Bank, including fines, injunctions, civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply and criminal prosecutions, any of which could adversely affect supplies of Spring Banks product candidates and significantly harm Spring Banks business, financial condition and results of operations.
Spring Banks current and anticipated future dependence upon others for the manufacture of Spring Banks product candidates may adversely affect Spring Banks future profit margins and Spring Banks ability to commercialize any products that receive marketing approval on a timely and competitive basis.
Spring Bank is subject to healthcare laws and regulations, which could expose Spring Bank to criminal sanctions, civil penalties, contractual damages, reputational harm, fines, disgorgement, exclusion from participation in government healthcare programs, curtailment or restricting of Spring Banks operations, and diminished profits and future earnings.
Healthcare providers, physicians and others will play a primary role in the recommendation and prescription of any products for which Spring Bank obtains marketing approval. Spring Banks future arrangements with healthcare providers, patients and third-party payors will expose Spring Bank to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which Spring Bank markets, sells and distributes any products for which Spring Bank obtains marketing approval. Restrictions under applicable U.S. federal and state healthcare laws and regulations include the following:
Anti-Kickback Statute. The federal healthcare Anti-Kickback Statute (the Anti-Kickback Statute) prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the Anti-Kickback Statute or specific intent to violate it in order to have committed a violation;
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False Claims Laws. Federal civil and criminal false claims laws and civil monetary penalties laws, including the federal False Claims Act, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented to the federal government claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
HIPAA. The federal Health Insurance Portability and Accountability Act of 1996, (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or for making any false statements relating to healthcare matters. Similar to the Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute in order to have committed a violation. Additionally, HIPAA, as amended by HITECH and its implementing regulations, imposes obligations on certain covered entities as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms with respect to safeguarding the privacy, security and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;
Privacy Regulations and the GDPR. Privacy and data security have become significant issues in the United States, Europe and in many other jurisdictions where Spring Bank may in the future conduct Spring Banks operations. Regulators globally are imposing greater monetary fines for privacy violations. For example, in 2016, the EU adopted the GDPR, which became effective on May 25, 2018. The GDPR applies to any company established in the EU as well as to those outside the EU if they collect and use personal data in connection with the offering goods or services to individuals in the EU or the monitoring of their behavior. The GDPR enhances data protection obligations for processors and controllers of personal data, including, for example, expanded disclosures about how personal information is to be used, limitations on retention of information, mandatory data breach notification requirements and onerous new obligations on services providers. Non-compliance with the GDPR may result in monetary penalties of up to 20 million or 4% of worldwide revenue, whichever is higher. The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of personal data, such as healthcare data or other sensitive information, could greatly increase Spring Banks cost of providing Spring Banks products and services or even prevent Spring Bank from offering certain services in jurisdictions in which Spring Bank may.
Transparency Requirements. The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Childrens Health Insurance Program, with specific exceptions, to report annually to the Department of Health and Human Services information related to certain payments and other transfers of value, to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;
FDCA. The U.S. Federal Food, Drug and Cosmetic Act (the FDCA), which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; and
Analogous State and Foreign Laws. Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, and transparency laws, may apply to sales or marketing arrangements, and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. In addition, some state laws require pharmaceutical companies to comply with the pharmaceutical industrys voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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Efforts to ensure that Spring Banks business arrangements with third parties, and Spring Banks business generally, will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that Spring Banks business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If Spring Banks operations are found to be in violation of any of these laws or any other governmental laws and regulations that may apply to Spring Bank, it may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, disgorgement, curtailment or restricting of Spring Banks operations, any of which could substantially disrupt Spring Banks operations and diminish Spring Banks profits and future earnings. If any of the physicians or other providers or entities with whom Spring Bank expects to do business is found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. The risk of Spring Banks being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of Spring Banks business activities, including Spring Banks relationships with physicians and other healthcare providers, some of whom will recommend, purchase and/or prescribe Spring Banks products, could be subject to challenge under one or more of such laws.
If Spring Bank fails to comply with environmental, health and safety laws and regulations, Spring Bank could become subject to fines or penalties or incur costs that could harm Spring Banks business.
Spring Bank is subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, Spring Banks operations may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products. Even if Spring Bank contracts with third parties for the disposal of these materials and waste products, Spring Bank cannot completely eliminate the risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of Spring Banks hazardous materials, Spring Bank could be held liable for any resulting damages, and any liability could exceed Spring Banks resources. Spring Bank also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.
Spring Bank maintains workers compensation insurance to cover Spring Bank for costs and expenses Spring Bank may incur due to injuries to Spring Banks employees resulting from the use of hazardous materials, but this insurance may not provide adequate coverage against potential liabilities. Spring Bank does not maintain insurance for any environmental liability or toxic tort claims that may be asserted against Spring Bank.
In addition, Spring Bank may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Current or future environmental laws and regulations may impair Spring Banks research, development or production efforts. In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.
Risks Related to Spring Banks Intellectual Property
If Spring Bank is unable to protect Spring Banks intellectual property rights or if Spring Banks intellectual property rights are inadequate for Spring Banks technology and product candidates, Spring Banks competitive position could be harmed.
Spring Banks success will depend in large part on Spring Banks ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to Spring Banks proprietary technology and product candidates. Spring Bank relies on trade secret, patent, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third parties. Spring Bank seeks to protect Spring Banks proprietary position by filing and prosecuting patent applications in the
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United States and abroad related to Spring Banks novel technologies and product candidates that are important to Spring Banks business.
The patent prosecution process is expensive and time-consuming, and Spring Bank may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that Spring Bank will fail to identify patentable aspects of Spring Banks research and development before it is too late to obtain patent protection. Although Spring Bank enters into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of Spring Banks research and development, such as Spring Banks employees, strategic partners, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose Spring Banks confidential information before a patent application is filed, thereby jeopardizing Spring Banks ability to seek patent protection.
Spring Bank may license patent rights that are valuable to Spring Banks business from third parties, in which event Spring Bank may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology or medicines underlying such licenses. Spring Bank cannot be certain that these patents and applications will be prosecuted and enforced in a manner consistent with the best interests of Spring Banks business. If any such licensor fails to maintain such patents, or lose rights to those patents, the rights Spring Bank has licensed may be reduced or eliminated and Spring Banks right to develop and commercialize any of Spring Banks product candidates that are the subject of such licensed rights could be adversely affected. In addition to the foregoing, the risks associated with patent rights that Spring Bank licenses from third parties also apply to patent rights Spring Bank owns.
The patent positions of biotechnology and pharmaceutical companies generally are highly uncertain, involve complex legal and factual questions and have in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of Spring Banks patents, including those patent rights licensed to Spring Bank by third parties, are highly uncertain. The steps Spring Bank or Spring Banks licensors have taken to protect Spring Banks proprietary rights may not be adequate to preclude misappropriation of Spring Banks proprietary information or infringement of Spring Banks intellectual property rights, both inside and outside the United States. Further, the examination process may require Spring Bank or Spring Banks licensors to narrow the claims for Spring Banks pending patent applications, which may limit the scope of patent protection that may be obtained if these applications issue as patents. The rights already granted under any of Spring Banks currently issued patents or those licensed to Spring Bank and those that may be granted under future issued patents may not provide Spring Bank with the proprietary protection or competitive advantages Spring Bank is seeking. Changes in the patent laws, implementing regulations or interpretation of the patent laws in the United States and other countries may also diminish the value of Spring Banks patents or narrow the scope of Spring Banks patent protection. If Spring Bank or Spring Banks licensors are unable to obtain and maintain patent protection for Spring Banks technology and product candidates, or if the scope of the patent protection obtained is not sufficient, Spring Banks competitors could develop and commercialize technology and products similar or superior to Spring Bank, and Spring Banks ability to successfully commercialize Spring Banks technology and product candidates may be adversely affected.
With respect to patent rights, Spring Bank does not know whether any of the pending patent applications for any of Spring Banks compounds will result in the issuance of patents that protect Spring Banks technology or products, or if any of Spring Banks or Spring Banks licensors issued patents will effectively prevent others from commercializing competitive technologies and products. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or in some cases not at all, until they are issued as a patent. Therefore, Spring Bank cannot be certain that Spring Bank or Spring Banks licensors were the first to make the inventions claimed in Spring Banks owned or licensed patents or pending patent applications, or that Spring Bank or Spring Banks licensors were the first to file for patent protection of such inventions.
Spring Banks pending applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Because the issuance of a
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patent is not conclusive as to its inventorship, scope, validity or enforceability, issued patents that Spring Bank own or have licensed from third parties may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in the loss of patent protection, the narrowing of claims in such patents or the invalidity or unenforceability of such patents, which could limit Spring Banks ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection for Spring Banks technology and products. Protecting against the unauthorized use of Spring Banks or Spring Banks licensors patented technology, trademarks and other intellectual property rights is expensive, difficult and in some cases may not be possible. In some cases, it may be difficult or impossible to detect third-party infringement or misappropriation of Spring Banks intellectual property rights, even in relation to issued patent claims, and proving any such infringement may be even more difficult.
If third parties initiate legal proceedings against Spring Bank alleging that Spring Bank is infringing their intellectual property rights, such litigation could be costly and time consuming and could prevent or delay Spring Bank from developing or commercializing Spring Banks product candidates.
Spring Banks commercial success depends upon Spring Banks ability to develop, manufacture, market and sell SB 11285, and any other product candidates and to use Spring Banks related proprietary technologies, without infringing the intellectual property and other proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, and interferences, post-grant review, inter partes review, and reexamination proceedings before the United States Patent and Trademark Office (USPTO), and corresponding foreign patent offices. As a result, Spring Bank may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to SB 11285 or any other product candidates, including interference or derivation proceedings before the USPTO. Third parties may assert infringement claims against Spring Bank based on existing patents or patents that may be granted in the future. The pharmaceutical and biotechnology industries have produced a significant number of patents, and it may not always be clear to industry participants, including Spring Bank, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
Third parties may assert that Spring Bank is employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods of treatment related to the use or manufacture of Spring Banks product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications, which may later result in issued patents that Spring Banks product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of Spring Banks technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of Spring Banks product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block Spring Banks ability to commercialize such product unless Spring Bank obtained a license under the applicable patents, or until such patents expire. Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of Spring Banks formulations, processes for manufacture or methods of use, the holders of any such patents may be able to block Spring Banks ability to develop and commercialize the applicable product candidate.
If Spring Bank were sued for patent infringement, Spring Bank would need to demonstrate that Spring Banks product candidates, products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and Spring Bank may not be able to do this. Proving invalidity is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. If Spring Bank is found to infringe a third partys intellectual property rights, Spring Bank could be required to obtain a license from such third party. However, Spring Bank may not be able to obtain any required license on commercially reasonable terms or at all. Under certain circumstances, Spring Bank could be forced, including by court order, to cease commercializing the applicable product candidate. In addition, in any such proceeding or litigation, Spring Bank
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could be found liable for monetary damages. A finding of infringement could prevent Spring Bank from commercializing the applicable product candidate or force Spring Bank to cease some of Spring Banks business operations, which could materially harm Spring Banks business.
Defense of claims of infringement, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from Spring Banks business. In the event of a successful claim of infringement against Spring Bank, it may have to pay substantial damages, including treble damages and attorneys fees for willful infringement, pay royalties, redesign Spring Banks infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. Parties making claims against Spring Bank may also obtain injunctive or other equitable relief, which could effectively block Spring Banks ability to develop and commercialize one or more of Spring Banks product candidates, which could materially harm Spring Banks business.
Most of Spring Banks competitors are larger than Spring Bank is and have substantially greater resources and may be able to sustain the costs of complex patent litigation longer than Spring Bank could. The uncertainties associated with litigation could have a material adverse effect on Spring Banks ability to raise the funds necessary to continue Spring Banks research and development, in-license needed technology, or enter into strategic partnerships.
Any claims by third parties that Spring Bank has misappropriated their confidential information or trade secrets could have a similar negative impact on Spring Banks business. Even if Spring Bank is successful in these proceedings, Spring Bank may incur substantial costs and the time and attention of Spring Banks management and scientific personnel could be diverted in pursuing these proceedings, which could significantly harm Spring Banks business and operating results. In addition, Spring Bank may not have sufficient resources to bring these actions to a successful conclusion.
While SB 11285 and any other product candidates that Spring Bank may develop will be observed in preclinical studies and/or clinical trials, Spring Bank believes that the use of Spring Banks product candidates in these preclinical studies and/or clinical trials falls or will fall within the scope of the exemptions provided by 35 U.S.C. Section 271(e) in the United States, which exempts from patent infringement liability activities reasonably related to the development and submission of information to the FDA. If these product candidates progress toward commercialization, the possibility of a patent infringement claim against Spring Bank increases. Spring Bank attempts to ensure that the methods Spring Bank employs to manufacture SB 11285, as well as the methods for their use that Spring Bank intends to promote, do not infringe other parties patents and other proprietary rights. There can be no assurance they do not, however, and competitors or other parties may assert that Spring Bank infringes their proprietary rights in any event.
In addition, Spring Bank plans to evaluate SB 11285 in combination with other product candidates and approved products that are covered by patents held by other companies or institutions. In the event that a labeling instruction is required in product packaging recommending that combination, Spring Bank could be accused of, or held liable for, infringement of the third-party patents covering the product candidate or product recommended for administration with SB 11285. In such a case, Spring Bank could be required to obtain a license from the other company or institution to use the required or desired package labeling, which may not be available on commercially reasonable terms, or at all.
The terms of Spring Banks patents may be inadequate to protect Spring Banks competitive position on Spring Banks products for an adequate amount of time.
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Spring Bank expects to seek extensions of patent terms in the United States and, if available, in other countries where Spring Bank is prosecuting patents. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications approved during the period of extension). However, the applicable authorities, including the FDA and the USPTO in the
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United States, and any equivalent regulatory authority in other countries, may not agree with Spring Banks assessment of whether such extensions are available, and may refuse to grant extensions to Spring Banks patents, or may grant more limited extensions than Spring Bank requests. If this occurs, Spring Banks competitors may be able to take advantage of Spring Banks investment in development and clinical trials by referencing Spring Banks clinical and preclinical data and launch their product earlier than might otherwise be the case.
Risks Related to Spring Banks Common Stock
The trading market in Spring Banks common stock has been limited and substantially less liquid than the average trading market for a stock quoted on The Nasdaq Capital Market.
Since Spring Banks initial listing on The Nasdaq Capital Market on May 6, 2016, the trading market in Spring Banks common stock has been extremely limited and substantially less liquid than the average trading market for companies quoted on The Nasdaq Capital Market. The quotation of Spring Banks common stock on The Nasdaq Capital Market does not assure that a meaningful, consistent and liquid trading market currently exists. Spring Bank cannot predict whether a more active market for Spring Banks common stock will develop in the future. An absence of an active trading market could adversely affect your ability to sell Spring Banks common stock at current market prices in short time periods, or possibly at all. Additionally, sales of a substantial number of shares of Spring Banks common stock in the public market, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of Spring Banks common stock even if Spring Banks business is doing well. Ultimately, market visibility for Spring Banks common stock may be limited and such lack of visibility may have a depressive effect on the market price for Spring Banks common stock.
The price of Spring Banks common stock may be volatile and fluctuate substantially, which could result in substantial losses for Spring Banks stockholders.
Spring Banks stock price is likely to be volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. Because of this volatility, you may not be able to sell your common stock at or above the price at which you purchased your shares. The market price for Spring Banks common stock may be influenced by many factors, including:
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results of clinical trials of Spring Banks product candidates or those of Spring Banks competitors; |
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the success of competitive products or technologies; |
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developments related to any future collaborations; |
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regulatory or legal developments in the United States and other countries; |
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development of new product candidates that may address Spring Banks markets and may make Spring Banks product candidates less attractive; |
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changes in physician, hospital or healthcare provider practices that may make Spring Banks product candidates less useful; |
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announcements by Spring Bank, Spring Banks partners or Spring Banks competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; developments or disputes concerning patent applications, issued patents or other proprietary rights; |
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the recruitment or departure of key personnel; |
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the level of expenses related to any of Spring Banks product candidates or clinical development programs; |
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failure to meet or exceed financial estimates and projections of the investment community or that Spring Bank provides to the public; |
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the results of Spring Banks efforts to discover, develop, acquire or in-license additional product candidates or products; |
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actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; |
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variations in Spring Banks financial results or those of companies that are perceived to be similar to Spring Bank; |
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changes in the structure of healthcare payment systems; |
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market conditions in the pharmaceutical and biotechnology sectors; |
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general economic, industry and market conditions; and |
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the other factors described in this Risk Factors section. |
Spring Bank is an emerging growth company, and the reduced disclosure requirements applicable to emerging growth companies may make Spring Banks common stock less attractive to investors.
Spring Bank is an emerging growth company, as defined in the JOBS Act, and may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the closing of Spring Banks initial public offering, which is December 31, 2021. However, if certain events occur prior to the end of such five-year period, including if Spring Bank becomes a large accelerated filer, Spring Banks annual gross revenues exceed $1.07 billion or Spring Bank issues more than $1.0 billion of non-convertible debt in any three-year period, Spring Bank will cease to be an emerging growth company prior to the end of such five-year period. For so long as Spring Bank remains an emerging growth company, Spring Bank is permitted and intends to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:
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being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced Managements Discussion and Analysis of Financial Condition and Results of Operations disclosure; |
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not being required to comply with the auditor attestation requirements in the assessment of Spring Banks internal control over financial reporting; |
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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditors report providing additional information about the audit and the financial statements; |
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reduced disclosure obligations regarding executive compensation; and |
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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. |
Spring Bank has taken advantage of these reduced reporting burdens. In particular, in connection with Spring Banks recent offerings, Spring Bank has provided only two years of audited financial statements and Spring Bank has not included all of the executive compensation related information that would be required if Spring Bank was not an emerging growth company. Spring Bank expects to continue to take advantage of some or all of the reporting exemptions available to emerging growth companies. Spring Bank cannot predict whether investors will find Spring Banks common stock less attractive if Spring Bank relies on these exemptions. If some investors find Spring Banks common stock less attractive as a result, there may be a less active trading market for Spring Banks common stock and Spring Banks stock price may be reduced or more volatile. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies. Spring Bank has irrevocably elected not to avail itself of this exemption from new or revised accounting standards and, therefore, Spring Bank will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
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Spring Bank incurs increased costs as a result of operating as a public company and Spring Banks management is required to devote substantial time to compliance initiatives and corporate governance practices.
As a public company, and particularly after Spring Bank is no longer an emerging growth company, Spring Bank will incur significant legal, accounting and other expenses that Spring Bank did not incur as a private company. The Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act), the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the exchange or market upon which Spring Bank trades and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Spring Banks management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations have increased Spring Banks legal and financial compliance costs and will make some activities more time-consuming and costly. For example, Spring Bank expects that these rules and regulations may make it more difficult and more expensive for Spring Bank to maintain Spring Banks director and officer liability insurance policies at a reasonable cost, which in turn could make it more difficult for Spring Bank to attract and retain qualified members of Spring Banks Board of Directors.
Spring Bank cannot predict or estimate the amount of additional costs Spring Bank may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as regulatory and governing bodies provide new guidance. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
While Spring Bank remains an emerging growth company, Spring Bank is not required to include an attestation report on internal control over financial reporting issued by Spring Banks independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, Spring Bank is engaged in a process to document and evaluate Spring Banks internal control over financial reporting, which is both costly and challenging. In this regard, Spring Bank continues to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
If Spring Bank fails to maintain an effective system of disclosure controls and internal control over financial reporting, Spring Banks ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.
As a public company, Spring Bank is subject to the reporting requirements of the Securities and Exchange Commission, the Sarbanes-Oxley Act and the listing standards of the Nasdaq Capital Market, the exchange on which Spring Banks common stock is listed. Spring Bank expects that the requirements of these rules and regulations will continue to increase Spring Banks legal, accounting and financial compliance costs, make some activities more difficult, time consuming and costly and place significant strain on Spring Banks personnel, systems and resources.
The Sarbanes-Oxley Act requires, among other things, that Spring Bank maintain effective disclosure controls and procedures and internal control over financial reporting. Spring Bank is continuing to refine Spring Banks disclosure controls and other procedures that are designed to ensure that the information that Spring Bank is required to disclose in the reports that Spring Bank will file with the SEC is properly recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Spring Bank is also continuing to improve its internal control over financial reporting. Spring Bank has expended, and anticipates that it will continue to expend, significant resources in order to maintain and improve the effectiveness of its disclosure controls and procedures and internal control over financial reporting.
Spring Banks current controls and any new controls that Spring Bank develops in the future may become inadequate because of changes in conditions in Spring Banks business. Further, weaknesses in Spring Banks
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disclosure controls or Spring Banks internal control over financial reporting may be discovered in the future. Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm Spring Banks operating results or cause Spring Bank to fail to meet Spring Banks reporting obligations and may result in a restatement of Spring Banks financial statements for prior periods. Any failure to implement and maintain effective internal control over financial reporting could also adversely affect the results of management reports and independent registered public accounting firm audits of Spring Banks internal control over financial reporting that Spring Bank will be required to include in Spring Banks periodic reports that will be filed with the SEC. If Spring Bank were to have ineffective disclosure controls and procedures or internal control over financial reporting, its investors could lose confidence in its reported financial and other information, which would likely have a negative effect on the market price of Spring Bank common stock.
Provisions in Spring Banks restated certificate of incorporation and amended and restated bylaws and under Delaware law could make an acquisition of Spring Bank, which may be beneficial to Spring Banks stockholders, more difficult and may prevent attempts by Spring Banks stockholders to replace or remove Spring Banks current management.
Provisions in Spring Banks restated certificate of incorporation and Spring Banks amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of Spring Bank that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of Spring Banks common stock, thereby depressing the market price of Spring Banks common stock. In addition, because Spring Bank Board is responsible for appointing the members of Spring Banks management team, these provisions may frustrate or prevent any attempts by Spring Banks stockholders to replace or remove Spring Banks current management by making it more difficult for stockholders to replace members of Spring Bank Board. Among other things, these provisions include those establishing:
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a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of Spring Bank Board; |
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no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; |
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the exclusive right of Spring Bank Board to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from filling vacancies on Spring Bank Board; |
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the ability of Spring Bank Board to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer; |
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the ability of Spring Bank Board to alter Spring Banks bylaws without obtaining stockholder approval; |
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the required approval of the holders of at least a majority of the shares entitled to vote at an election of directors to adopt, amend or repeal Spring Banks bylaws or repeal the provisions of Spring Banks restated certificate of incorporation regarding the election and removal of directors; |
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a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of Spring Banks stockholders; |
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the requirement that a special meeting of stockholders may be called only by the board of directors, the chairman of the board of directors, the chief executive officer or stockholders holding a majority of Spring Banks issued and outstanding common stock, which may delay the ability of Spring Banks stockholders to force consideration of a proposal or to take action, including the removal of directors; and |
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advance notice procedures that stockholders must comply with in order to nominate candidates to Spring Bank Board or to propose matters to be acted upon at a stockholders meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirers own slate of directors or otherwise attempting to obtain control of Spring Bank. |
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Moreover, because Spring Bank is incorporated in Delaware, Spring Bank is governed by the provisions of Section 203 of the DGCL, which prohibits a person who owns in excess of 15% of Spring Banks outstanding voting stock from merging or combining with Spring Bank for a period of three years after the date of the transaction in which the person acquired in excess of 15% of Spring Banks outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Furthermore, Spring Banks restated certificate of incorporation specifies that, unless Spring Bank consents in writing to the selection of an alternative forum, and to the fullest extent permitted by law, as described below, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any derivative action or proceeding brought on Spring Banks behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against Spring Bank arising pursuant to the DGCL, Spring Banks amended and restated certificate of incorporation, or Spring Banks amended and restated bylaws; or any action asserting a claim against Spring Bank that is governed by the internal affairs doctrine. This exclusive forum provision does not apply to suits brought to enforce a duty or liability created by the Exchange Act. Further, Spring Banks amended and restated bylaws provide that, unless Spring Bank consents in writing to an alternative forum, the U.S. federal district courts will have exclusive jurisdiction for any complaint asserting a cause of action under the Securities Act. However, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. There is uncertainty as to whether a court would enforce this provision with respect to claims under the Securities Act, and Spring Banks stockholders cannot waive Spring Banks compliance with the federal securities laws and the rules and regulations thereunder.
Spring Bank believes these provisions provide increased consistency in the application of Delaware law by chancellors particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. However, these provisions may have the effect of discouraging lawsuits against Spring Banks directors and officers. The enforceability of similar choice of forum provisions in other companies certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against Spring Bank, a court could find the choice of forum provisions contained in Spring Banks restated certificate of incorporation or amended and restated bylaws to be inapplicable or unenforceable in such action.
Spring Banks ability to use Spring Banks net operating loss and credit carryforwards to offset future taxable income may be subject to certain limitations.
As of December 31, 2019, Spring Bank had a balance of federal and state net operating loss (NOL) carryforwards of approximately $115.6 million and $116.5 million, respectively. The federal NOL carryforwards of $61.5 million expire between 2029 and 2037 and $54.1 million carryforward indefinitely. The state NOL carryforwards expire between 2030 and 2039. Spring Banks ability to utilize Spring Banks NOL and credit carryforwards is dependent upon Spring Banks ability to generate taxable income in future periods and may be limited due to restrictions imposed on utilization of NOL and credit carryforwards under federal and state laws upon a change in ownership, as described in more detail below.
Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code), a corporation that undergoes an ownership change, is subject to limitations on its ability to use its pre-change NOL carryforwards, and other pre-change tax attributes (such as research tax credits) to offset its post-change taxable income. For these purposes, an ownership change generally occurs where the equity ownership of one or more stockholders or groups of stockholders who owns at least 5% of a corporations stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a three-year period (calculated on a rolling basis). Spring Bank has made a preliminary determination that an ownership change likely occurred in each of April 2012 and December 2013. However, Spring Bank anticipates that the annual limitation attributable to such ownership change will not limit its ability to use its NOLs to offset future taxable income. Spring Bank may have experienced other ownership changes in the past. The Exchange is expected to result in an additional ownership change and Spring Bank may experience ownership changes in the future, some of which are outside
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the companys control. These ownership changes may limit the ability of Spring Banks to utilize its NOLs or credits under Sections 382 and 383 of the Code. Accordingly, Spring Bank may not be able to utilize a material portion of Spring Banks NOLs or credits. Limitations on Spring Banks ability to utilize Spring Banks NOLs to offset U.S. federal taxable income could potentially result in increased future tax liability to Spring Bank. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed.
Because U.S. federal NOLs arising in taxable years beginning before January 1, 2018, generally may be carried forward up to 20 years, the annual limitation under Sections 382 and 383 of the Code may effectively provide a cap on the cumulative amount of pre-ownership change losses. In addition, if an ownership change were to occur, it is possible that the limitations imposed on Spring Banks ability to use pre-ownership change losses and certain recognized built-in losses could cause a net increase in Spring Banks U.S. federal income tax liability and require U.S. federal income taxes to be paid earlier than otherwise would be paid if such limitations were not in effect. Further, if for financial reporting purposes the amount or value of these deferred tax assets is reduced, such reduction could have a negative impact on the book value of Spring Banks common stock.
In addition to the limitations discussed above under Sections 382 and 383 of the Code, the utilization of NOLs incurred in taxable years beginning after December 31, 2017, are subject to limitations adopted by the TCJA, as modified by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Under the TCJA, in general, NOLs generated in taxable years beginning after December 31, 2017 may offset no more than 80 percent of such years taxable income and there is no ability for such NOLs to be carried back to a prior taxable year. The CARES Act modifies the TCJA with respect to the TCJAs limitation on the deduction of NOLs and provides that NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021, may be carried back to each of the five taxable years preceding the tax year of such loss, but NOLs arising in taxable years beginning after December 31, 2020 may not be carried back. In addition, the CARES Act eliminates the limitation on the deduction of NOLs to 80 percent of current year taxable income for taxable years beginning before January 1, 2021. As a result of such limitation, Spring Bank may be required to pay federal income tax in some future year notwithstanding that Spring Bank has a net loss for all years in the aggregate.
Because Spring Bank does not anticipate declaring or paying any cash dividends on Spring Banks common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
Spring Bank has never declared or paid cash dividends on Spring Banks common stock. Spring Bank currently intends to retain all of Spring Banks future earnings, if any, to finance the growth and development of Spring Banks business. As a result, capital appreciation, if any, of Spring Banks common stock will be your sole source of gain for the foreseeable future.
Spring Bank could be subject to securities class action litigation.
When the market price of a stock is volatile, holders of that stock have often initiated securities class action litigation against the company that issued the stock. This risk is especially relevant for Spring Bank because pharmaceutical companies have experienced significant stock price volatility in recent years. If Spring Bank faces such litigation, it could result in substantial costs and a diversion of managements attention and resources, which could harm Spring Banks business. Spring Bank may not be successful in defending itself or asserting Spring Banks rights in future lawsuits, investigations, or claims that may be brought against Spring Bank and, as a result, Spring Banks business could be materially harmed. These lawsuits, arbitrations, investigations or claims may result in large judgments or settlements against Spring Bank, any of which could have a negative effect on Spring Banks financial performance and business. Additionally, lawsuits, arbitrations and investigations can be expensive to defend, whether or not the lawsuit, arbitration or investigation has merit, and the defense of these actions may divert the attention of Spring Banks management and other resources that would otherwise be engaged in running Spring Banks business.
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Risks Related to F-stars Financial Position and Need for Additional Capital
F-star is a clinical-stage immuno-oncology company and have incurred significant losses since F-stars inception. F-star expects to incur losses for the foreseeable future and may never achieve or maintain profitability.
F-star is a clinical-stage immuno-oncology company with a limited operating history. F-star incurred net losses of £35.0 million for the year ended December 31, 2019 and £10.2 million and £9.8 million for the six months ended June 30, 2020 and 2019, respectively, and net profits of £12.9 million and £3.8 million for the years ended December 31, 2018 and 2017, respectively. As of June 30, 2020, F-star had an accumulated loss of £25.7 million. F-stars losses have resulted principally from expenses incurred in research and development, preclinical testing and clinical development of its mAb2 product candidates as well as expenses incurred for research programs and from general and administrative costs associated with its operations. F-star expects to continue to incur significant and increasing operating losses for the foreseeable future as it continues its clinical trial plans, research and development efforts and seeks to obtain regulatory approval and commercialization of its tetravalent bispecific antibody (mAb2) product candidates, and F-star does not know whether or when it will become profitable. F-stars losses, among other things, will continue to cause its working capital and shareholders equity to decrease. F-star anticipates that its expenses will increase substantially if and as it:
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continues to develop and conduct clinical trials for its lead product candidate, FS118; |
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continues the research and development of its other mAb2 product candidates, including completing preclinical studies and commencing clinical trials for FS120 and FS222; |
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discovers and develops additional mAb2 product candidates and makes further investments in its modular antibody technology platform; |
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seeks regulatory approvals for any mAb2 product candidates that successfully complete clinical trials; |
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experiences any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges; |
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establishes a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities, whether alone or with third parties, to commercialize any mAb2 product candidates for which it may obtain regulatory approval, if any; |
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maintains, expands and protects its intellectual property portfolio, including litigation costs associated with defending against alleged patent infringement claims; |
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adds clinical, scientific, operational, financial and management information systems and personnel, including personnel to support its product development and potential future commercialization efforts; |
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expands its operations in the United States, Europe and other geographies; and |
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incurs additional legal, accounting and other expenses associated with operating as a public company. |
To date, F-star has funded its operations through private placements of equity securities and upfront and milestone payments and expense reimbursement payments received from its collaborators. F-star has invested substantially all of its financial resources and efforts to developing its mAb2 product candidates in immuno-oncology, building its intellectual property portfolio, developing its supply chain, conducting business planning, licensing F-stars technology to its collaborators, raising capital and providing general and administrative support for these operations. F-star does not currently have any approved products and has never generated any revenue from product sales.
To become and remain profitable, F-star must succeed in developing and eventually commercializing products that generate significant revenue. This will require F-star to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of its mAb2 product candidates supportive of product approval, discovering and developing additional mAb2 product candidates, obtaining regulatory approval for any mAb2 product candidates that successfully complete clinical trials, establishing manufacturing and marketing capabilities and ultimately selling any products for which it may obtain regulatory approval. F-star is only in the preliminary stages of most of these activities. F-star may never succeed in these activities and, even if it does, may never generate revenue that is significant enough to achieve or maintain profitability. Even if one or
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more of the mAb2 product candidates that F-star develops is approved for commercial sale, F-star anticipates incurring significant costs associated with commercializing any approved product candidate. F-stars expenses could increase beyond current expectations if F-star is required by the FDA, the EMA or other comparable foreign regulatory agencies to perform clinical trials or studies in addition to those that F-star currently anticipates. Even if F-star is able to generate revenue from the sale of any approved products, it may not become profitable and may need to obtain additional funding to continue operations.
Even if F-star achieves profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. F-stars failure to become and remain profitable could impair its ability to raise capital, expand its business, maintain its research and development efforts or continue its operations and you could lose some or all of your investment.
F-stars limited operating history may make it difficult to evaluate the success of its business to date and to assess F-stars future viability.
Since inception, F-star has invested most of its resources in developing its modular antibody technology platform, its mAb2 technology and mAb2 product candidates, building its intellectual property portfolio, conducting business planning, licensing its technology to its collaborators, raising capital and providing general and administrative support for these operations. F-stars most advanced mAb2 product candidate, FS118, is in a Phase 1 clinical trial in heavily pretreated patients with advanced cancer who have relapsed on programmed cell death ligand-1 (PD-L1), or programmed cell death protein-1, (PD-1), checkpoint inhibitor therapies. F-star has not yet demonstrated its ability to successfully complete any Phase 1 clinical trials, Phase 2 clinical trials or any Phase 3 or other pivotal clinical trials, obtain regulatory approvals, manufacture a commercial-scale product or arrange for a third party to do so on its behalf or conduct sales and marketing activities necessary for successful product commercialization. In addition, given its limited operating history, F-star may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors in achieving its business objectives. Additionally, F-star expects its financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond F-stars control. Consequently, any predictions you make about the F-stars future success or viability may not be as accurate as they could be if F-star had a longer operating history or more experience developing mAb2 product candidates.
F-star will need substantial additional funding in order to complete the development and commence commercialization of its mAb2 product candidates. Failure to obtain this necessary capital at acceptable terms and when needed may force it to delay, reduce or eliminate its product development programs or commercialization efforts.
F-star expects its expenses to increase in connection with its ongoing activities, particularly as F-star completes the Phase 1 clinical trial of FS118 and initiates later-stage clinical development, and continues to research, develop and initiate clinical trials of FS120, FS222 and any other mAb2 product candidates. In addition, if F-star obtains regulatory approval for any of its mAb2 product candidates, it expects to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
Furthermore, upon the Closing, F-star expects to incur additional costs associated with operating as a public company. Accordingly, F-star will need to obtain substantial additional funding in connection with its continuing operations. If F-star is unable to raise capital when needed or on attractive terms, it could be forced to delay, reduce or eliminate its product development programs or any future commercialization efforts.
F-star expects that its available cash and cash equivalents immediately prior to the completion of the Exchange, together with net cash held by Spring Bank upon consummation of the Exchange, the anticipated proceeds of approximately $25.0 million from the Pre-Closing Financing, the projected receipt of contingent milestones and research and development payments under its current collaborations with Merck and Denali and annual UK research and development tax refunds will enable it to fund its operating expenses, preclinical and clinical trial costs, including capped costs per the CVR Agreement towards continuing the ongoing Phase 1a/1b clinical trial of Spring Banks SB 11285 program and capital expenditure requirements through at least the next
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24 months. However, F-star has based this estimate on assumptions that may prove to be wrong, including raising at least $25.0 million in the Pre-Closing Financing and the timing of contingent milestones and research and development payments from the current collaborations with Merck and Denali, and it could use its capital resources sooner than it currently expects. The combined company will need to raise additional capital to complete the development and commercialization of FS118, FS120, FS222, if approved, and may also need to raise additional funds to pursue other development activities related to additional product candidates.
F-stars future capital requirements will depend on many factors, including:
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the cost, progress, results of the Phase 1 clinical trial of FS118 and any later-stage clinical trials for this product candidate; |
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the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for its other mAb2 product candidates, including FS120, FS222 and any future product candidate; |
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the number of potential new mAb2 product candidates F-star identifies and decides to develop; |
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the cost of manufacturing drug supply for the clinical trials of its mAb2 product candidates; |
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the time and costs involved in obtaining regulatory approval for its mAb2 product candidates and any delays F-star may encounter as a result of evolving regulatory requirements or adverse clinical trial results with respect to any of its mAb2 product candidates; |
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the costs involved in growing F-stars organization to the size and expertise needed to allow for the research, development and potential commercialization of F-stars current or any future mAb2 product candidates; |
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fulfilling obligations under F-stars existing collaboration agreements and the entry into new collaboration agreements; |
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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing its intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that F-star is infringing upon their intellectual property rights; |
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the cost of commercialization activities and costs involved in the creation of an effective sales, marketing and healthcare compliance organization for any mAb2 product candidates F-star develops, if approved; |
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the potential additional expenses attributable to adjusting F-stars development plans (including any supply related matters) to the COVID-19 pandemic; |
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the revenue, if any, received from commercial sales of its mAb2 product candidates for which F-star receive marketing approval; and |
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the costs of operating as a public company. |
Until F-star can generate sufficient product revenue to finance its cash requirements, which it may never do, F-star expects to finance its future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. Disruptions in the financial markets in general and more recently due to the COVID-19 pandemic have made equity and debt financing more difficult to obtain, and may have a material adverse effect on F-stars ability to meet its fundraising needs.
F-stars ability to raise additional funds will depend on financial, economic and market conditions and other factors, over which it may have no or limited control. If adequate funds are not available on commercially acceptable terms when needed, F-star may be forced to delay, reduce or terminate the development or commercialization of all or part of its research programs or mAb2 product candidates or it may be unable to take advantage of future business opportunities.
Raising additional capital may cause dilution to holders of existing shareholders of F-star, restrict F-stars operations or require F-star to relinquish rights to its technologies or mAb2 product candidates.
Until such time, if ever, as F-star can generate substantial product revenues, F-star expects to finance its operations with its existing cash and cash equivalents, including the Pre-Closing Financing and revenue from its
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collaborations. In order to further advance development of its mAb2 product candidates, discover additional mAb2 product candidates and pursue its other business objectives, however, F-star will need to seek additional funds.
F-star cannot guarantee that future financing will be available in sufficient amounts or on commercially reasonable terms, if at all. To the extent that F-star raises additional capital by issuing equity securities, F-stars existing shareholders ownership may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect F-stars rights as a shareholder. Equity and debt financing, if available, may involve agreements that include covenants limiting or restricting F-stars ability to take specific actions, such as redeeming F-stars shares, making investments, incurring additional debt, making capital expenditures or declaring dividends.
The incurrence of indebtedness could result in increased fixed payment obligations and F-star may be required to agree to certain restrictive covenants therein, such as limitations on F-stars ability to incur additional debt, limitations on F-stars ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely affect F-stars ability to conduct its business.
If F-star is unable to obtain funding on a timely basis, F-star may be required to significantly curtail, delay or discontinue one or more of its research or development programs or the commercialization of any of its mAb2 product candidates, if approved, or be unable to expand its operations or otherwise capitalize on its business opportunities, as desired, which could materially affect its business, financial condition and results of operations.
F-star will need to hire additional qualified accounting personnel in order to remediate material weaknesses in its internal control over financial reporting, and F-star will need to expend any additional resources and efforts that may be necessary to establish and to maintain the effectiveness of its internal control over financial reporting and its disclosure controls and procedures.
Although F-star is not yet subject to the certification or attestation requirements of Section 404 of the Sarbanes-Oxley Act, in connection with the preparation and audit of its financial statements for the year ended December 31, 2019, its management identified two material weaknesses related to its financial reporting process. PCAOB guidance regarding managements report on internal control over financial reporting defines a material weakness as a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of its annual or interim financial statements will not be prevented or detected and corrected on a timely basis. As a result, the financial statements for the years ended December 31, 2017 and 2018 required restatements related to income taxes. Additionally, these material weaknesses could result in further misstatements of account balances or disclosures that could result in further material misstatements to the F-star annual or interim consolidated financial statements that would not be prevented or detected.
These material weaknesses relate to (i) the lack of formal policies and procedures and sufficient complement of personnel to implement effective segregation of duties and (ii) the company did not have sufficient formality and evidence of controls over key reports and spreadsheets.
F-star has commenced measures to remediate these material weaknesses and it intends to hire additional finance and accounting personnel with appropriate expertise to perform specific functions and allow for proper segregation of duties, design key controls and implement improved processes and internal controls, build its financial management and reporting infrastructure, and further develop and document its accounting policies and financial reporting procedures, including ongoing senior management review and audit committee oversight.
There can be no assurance that F-star will be successful in pursuing these measures or that these measures will significantly improve or remediate the material weaknesses described above. There is also no assurance that F-star has identified all of its material weaknesses or that F-star will not in the future have additional material weaknesses. If F-star fails to remediate the material weaknesses or to meet the demands that will be placed upon it as a public company, including the requirements of the Sarbanes-Oxley Act, F-star may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in F-stars financial reporting, and F-stars
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share price may decline as a result. F-star also could become subject to investigations by Nasdaq, the SEC or other regulatory authorities.
F-star believes its current cash and cash equivalents will be sufficient to fund its business only for a limited amount of time, and if it is not able to raise additional funds, it may be unable to continue as a going concern.
As of August 28, 2020, the date of approval of the consolidated financial statements for the year ended December 31, 2019 and not taking into account any proceeds raised in the Pre-Closing Financing, F-star does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. This raises substantial doubt over F-stars ability to continue as a going concern.
Concurrently with the execution of the Exchange Agreement on July 29, 2020, certain existing investors of F-star, pursuant to binding equity commitment letters by and between each investor and F-star, agreed to subscribe for ordinary shares of F-star in a private placement as of immediately prior to the Closing (the Pre-Closing Financing). In addition, F-star expects to seek equity financing from new investors as part of the Pre-Closing Financing. As of , 2020, F-star had received commitments from investors to purchase $ million of ordinary shares of F-star in the Pre-Closing Financing, and F-star may continue to seek additional commitments in the Pre-Closing Financing until 11:59 p.m., Eastern time on the 10th day prior to the Special Meeting. The closing of the Exchange Agreement would provide access to the existing cash deposits of Spring Bank as well as expected additional equity financing to be raised by F-star in the Pre-Closing Financing. The expected closing is anticipated in the fourth quarter of 2020. The closing of the Exchange is, however, subject to approval by the shareholders of Spring Bank.
Risks Related to Development and Commercialization
If F-star is unable to advance its current or future mAb2 product candidates through clinical trials, obtain marketing approval and ultimately commercialize any mAb2 product candidates F-star develops, or if it experiences significant delays in doing so, F-stars business will be materially harmed.
F-star is early in its mAb2 product candidate development efforts and only has one mAb2 product candidate in clinical development, which is still in early-stage clinical trials. F-star has invested substantially all of its efforts and financial resources in the development of its proprietary mAb2 technology, identification of targets and preclinical development of its mAb2 product candidates.
F-stars ability to generate product revenues, which F-star does not expect will occur for several years, if ever, will depend heavily on the successful development and eventual commercialization of the mAb2 product candidates F-star develops, which may never occur. F-stars current mAb2 product candidates, and any future mAb2 product candidates F-star develops, will require additional preclinical and clinical development, management of clinical, preclinical and manufacturing activities, marketing approval in the United States and other jurisdictions, demonstrating cost effectiveness to pricing and reimbursement authorities in various jurisdictions, obtaining and securing sufficient manufacturing supply for both clinical development and commercial production, building of a commercial organization, and substantial investment and significant marketing efforts before F-star generate any revenues from any future product sales. Moreover, the success of F-stars current and future mAb2 product candidates will depend on several factors, including the following:
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successful and timely completion of preclinical studies, including in vivo animal studies if necessary, and human clinical trials; |
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sufficiency of F-stars financial and other resources to complete the necessary preclinical studies and clinical trials; |
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receiving regulatory approvals or authorizations for conducting F-stars planned clinical trials or future clinical trials; |
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initiation and successful patient enrollment in and completion of clinical trials on a timely basis; |
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safety, tolerability and efficacy profiles that are satisfactory to the FDA, the EMA or any other comparable foreign regulatory authority for a product to receive marketing approval; |
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timely receipt of marketing approvals for F-stars mAb2 product candidates from applicable regulatory authorities; |
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the extent of any required post-marketing approval commitments made to applicable regulatory authorities; |
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establishing and scaling up, either alone or with third-party manufacturers, manufacturing capabilities of clinical supply for F-stars clinical trials and commercial manufacturing, if any mAb2 product candidates are approved; |
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obtaining and maintaining patent and trade secret protection or regulatory exclusivity for F-stars mAb2 product candidates, both in the United States and internationally; |
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successfully scaling a sales and marketing organization and launching commercial sales of F-stars mAb2 product candidates, if approved; |
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acceptance of F-stars mAb2 product candidates benefits and uses, if approved, by patients, the medical community and third-party payors; |
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maintaining a continued acceptable safety profile of F-stars mAb2 product candidates following marketing approval and commercial launch; |
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effectively competing with companies developing and commercializing other therapies in the same indications targeted by F-stars mAb2 product candidates; |
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obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors for any approved products; and |
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enforcing and defending intellectual property rights and claims. |
If F-star is not successful with respect to one or more of these factors in a timely manner or at all, F-star could experience significant delays or an inability to successfully commercialize any mAb2 product candidates F-star develops, which would materially harm F-stars business. If F-star does not receive marketing approvals for F-stars current and future product candidates, F-star may not be able to continue its operations.
All of F-stars mAb2 product candidates are in preclinical or early clinical development. Clinical trials are difficult to design and implement, and they involve a lengthy and expensive process with uncertain outcomes. F-star may experience delays in completing, or ultimately be unable to complete, the development and commercialization of F-stars current and future mAb2 product candidates.
Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process and F-stars future clinical trial results may not be successful.
To date, F-star has not completed any clinical trials required for the approval of any of its mAb2 product candidates. Although F-star expects completion of the current Phase 1 clinical trial of FS118 in the fourth quarter of 2020 and initiation of a Phase 1 clinical trial for FS120 in the fourth quarter of 2020, and it also plans to submit a Clinical Trial Application (CTA), to the EMA for FS222 in the second half of 2020, F-star may experience delays in its ongoing clinical trials or preclinical studies and F-star does not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time, have sufficient drug supply for F-stars mAb2 product candidates on a timely basis or be completed on schedule, if at all. F-star may also experience numerous unforeseen events during its clinical trials that could delay or prevent F-stars ability to receive marketing approval or to commercialize the mAb2 product candidates F-star develops, including:
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delays in or failure to obtain regulatory approval to commence a clinical trial; |
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delays in or failure to reach agreement on acceptable terms with prospective contract research organizations (CROs), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
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delays in or failure to obtain institutional review board (IRB), approval at each site; |
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delays in or failure to recruit a sufficient number of suitable patients to participate in a trial; |
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failure to have participants complete a trial or return for post-treatment follow-up; |
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clinical sites deviating from trial protocol or dropping out of a trial; |
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delays in adding new clinical trial sites; |
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failure to manufacture sufficient quantities of a mAb2 product candidate for use in clinical trials in a timely manner; |
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safety or tolerability concerns that could cause it or F-stars collaborators, as applicable, to suspend or terminate a trial if F-star or F-stars collaborators find that the participants are being exposed to unacceptable health risks; |
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changes in regulatory requirements, policies and guidelines; |
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failure of F-stars third-party research contractors to comply with regulatory requirements or meet their contractual obligations to it in a timely manner, or at all; |
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delays in establishing the appropriate dosage levels for a particular product candidate through clinical trials; |
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the quality or stability of the mAb2 product candidate falling below acceptable standards; and |
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business interruptions resulting from pandemics, including those related to COVID-19, geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires. |
F-star could encounter delays if a clinical trial is suspended or terminated by it, by the IRBs of the institutions in which such trials are being conducted or ethics committees, or by the FDA, the EMA, or other comparable foreign regulatory authorities, or if a trial is recommended for suspension or termination by the Data Review Committee (DRC), or Data Safety Monitoring Board (DSMB), for such trial. Any such authorities may impose such a suspension or termination of ongoing human subjects research due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or F-stars clinical protocols, inspection of the clinical trial operations or trial site by the FDA, the EMA, or other comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, including those relating to the class to which F-stars mAb2 product candidates belong, failure to demonstrate a benefit from using a mAb2 product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If F-star experiences delays in the completion of, or if F-star terminates, any clinical trial of its mAb2 product candidates, the commercial prospects of its mAb2 product candidates will be harmed, and F-stars ability to generate product revenues from any of these mAb2 product candidates will be delayed or may become impossible. In addition, any delays in completing clinical trials will increase F-stars costs, slow down F-stars mAb2 product candidate development and approval process and jeopardize F-stars ability to commence product sales and generate revenues. Moreover, if F-star makes changes to F-stars mAb2 product candidates, F-star may need to conduct additional scientific studies to bridge its modified mAb2 product candidates to earlier versions, which could delay F-stars clinical development plan or marketing approval for F-stars mAb2 product candidates. Significant clinical trial delays could also allow F-stars competitors to bring products to market before F-star does or shorten any periods during which F-star has the exclusive right to commercialize F-stars mAb2 product candidates and impair F-stars ability to commercialize its mAb2 product candidates.
Any of these occurrences may harm F-stars business, reputation, financial condition and results of operations significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval for F-stars mAb2 product candidates or result in the cessation of development of F-stars mAb2 product candidates.
F-stars clinical trials may fail to demonstrate adequately the safety and efficacy of any of F-stars mAb2 product candidates, which would prevent or delay regulatory approval and commercialization.
To obtain the requisite regulatory approvals to market and sell any of F-stars mAb2 product candidates, including FS118, FS120, FS222 and any other future product candidates, F-star must demonstrate through
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extensive preclinical studies and clinical trials that F-stars products are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process and F-stars future clinical trial results may not be successful. Further, the process of obtaining regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications, patient population and regulatory agency considering the products marketing application. Prior to obtaining approval to commercialize a mAb2 product candidate in the United States or abroad, F-star or F-stars potential future collaborators must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA, the EMA or other comparable foreign regulatory authorities, that such mAb2 product candidates are safe and effective for their intended uses.
Clinical trials that F-star conducts may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market F-stars mAb2 product candidates. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. If the results of F-stars ongoing or future clinical trials are inconclusive with respect to the efficacy of F-stars mAb2 product candidates, if F-star does not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with its mAb2 product candidates, F-star may be delayed in obtaining marketing approval, if at all.
Even if the trials are successfully completed, clinical data are often susceptible to varying interpretations and analyses, and F-star cannot guarantee that the FDA, the EMA, or other comparable foreign regulatory authorities will interpret the results as F-star does, and more trials could be required before F-star submits its mAb2 product candidates for approval. F-star cannot guarantee that the FDA, the EMA or other comparable foreign regulatory authorities will view F-stars mAb2 product candidates as being effective and having a favorable benefit-risk profile even if positive results are observed in clinical trials. To the extent that the results of the trials are not satisfactory to the FDA, the EMA or other comparable foreign regulatory authorities for support of a marketing application, approval of F-stars mAb2 product candidates may be significantly delayed, or F-star may be required to expend significant additional resources, which may not be available to F-star, to conduct additional trials in support of potential approval of F-stars mAb2 product candidates.
Preclinical drug development is uncertain. Some or all of F-stars preclinical mAb2 product candidates, such as FS120 and FS222 may experience delays or may never advance to clinical trials, which would adversely affect F-stars ability to obtain regulatory approvals or commercialize these mAb2 product candidates on a timely basis or at all, which would have an adverse effect on F-stars business.
Before F-star can commence clinical trials for a mAb2 product candidate, F-star must complete extensive preclinical testing and studies that support F-stars INDs in the United States, or CTAs in Europe. Conducting preclinical testing is a lengthy, time-consuming and expensive process and delays associated with mAb2 product candidates for which F-star is directly conducting preclinical testing and studies may cause it to incur additional operating expenses. Although F-star is currently conducting a Phase 1 clinical trial for FS118 and preparing for a Phase 1 clinical trial for FS120, F-star cannot be certain of the timely completion or outcome. Additionally, while F-star currently intends to submit a CTA to the EMA, for FS222 in the third quarter of 2020, F-star cannot be sure that it will be able to submit the CTA on that timeline, if at all, and F-star cannot be sure that submission of INDs or CTAs for this mAb2 product candidate or other mAb2 product candidates in the future will result in the FDA or the EMA allowing clinical trials for such candidates to begin.
The results of preclinical studies and early-stage clinical trials of F-stars mAb2 product candidates may not be predictive of the results of later-stage clinical trials. Initial success in F-stars ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials.
Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Furthermore, there can be no
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assurance that any of F-stars clinical trials will ultimately be successful or support further clinical development of any of F-stars mAb2 product candidates. There is a high failure rate for drugs proceeding through clinical trials. Many companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development and F-star cannot be certain that it will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or EMA approval. Any such setbacks in F-stars clinical development could have a material adverse effect on F-stars business, financial condition and results of operations.
Additionally, some of the clinical trials F-star conducts may include open-label trials conducted at a limited number of clinical sites on a limited number of patients. An open-label clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved product or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a patient bias where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. Moreover, patients selected for early-stage clinical trials often include the most severe sufferers and their symptoms may have been bound to improve notwithstanding the new treatment. In addition, open-label clinical trials may be subject to an investigator bias where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.
Interim, topline and preliminary data from F-stars clinical trials that F-star announces or publishes from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, F-star may publish interim, topline or preliminary data from F-stars clinical trials. Preliminary and interim data from F-stars clinical trials may change as more patient data become available. Preliminary or interim data from F-stars clinical trials are not necessarily predictive of final results. Preliminary and interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, more patient data become available and F-star issues its final clinical trial report. Interim, topline and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data F-star previously published. As a result, preliminary, topline and interim data should be viewed with caution until the final data are available. Material adverse changes in the final data compared to the interim data could significantly harm F-stars business prospects.
Further, others, including regulatory agencies, may not accept or agree with F-stars assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular mAb2 product candidate or product, if any, and F-star in general. In addition, the information F-star chooses to publicly disclose regarding a particular preclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what F-star determines is the material or otherwise appropriate information to include in F-stars disclosure, and any information F-star determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, if any, mAb2 product candidate or F-stars business. If the preliminary and interim data that F-star reports differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, F-stars ability to obtain approval for, and commercialize, F-stars mAb2 product candidates may be harmed, which could harm F-stars business, operating results, prospects or financial condition.
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F-stars mAb2 product candidates may have serious adverse, undesirable or unacceptable side effects that may delay or prevent marketing approval. If such side effects are identified during the development of F-stars mAb2 product candidates or following approval F-star may need to abandon development of such mAb2 product candidates, the commercial profile of any approved label may be limited, or F-star may be subject to other significant negative consequences following marketing approval.
Undesirable side effects that may be caused by F-stars mAb2 product candidates could cause it or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or other comparable foreign regulatory authorities. While F-stars mAb2 product candidates in F-stars preclinical studies, and the early clinical trial experience with FS118 to date have generally been well-tolerated from a risk-benefit perspective, the results from future preclinical studies and clinical trials, including of F-stars other mAb2 product candidates, may not support this conclusion.
The results of F-stars ongoing Phase 1 clinical trial of FS118 and future clinical trials of this and other mAb2 product candidates may show that F-stars mAb2 product candidates cause undesirable or unacceptable side effects or even death. In such an event, F-stars trials could be suspended or terminated and the FDA, the EMA or other comparable foreign regulatory authorities could order it to cease further development of or deny approval of F-stars mAb2 product candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Further, because all of F-stars current mAb2 product candidates are based on F-stars modular antibody technology platform and F-stars mAb2 technology, any adverse safety or efficacy findings related to any mAb2 product candidate or preclinical program may adversely impact the viability of F-stars other mAb2 product candidates or preclinical programs. Any of these occurrences may harm F-stars business, reputation, financial condition and results of operations significantly. Additionally, if any of F-stars mAb2 product candidates receives marketing approval and F-star or others later identify undesirable or unacceptable side effects caused by such products, a number of potentially significant negative consequences could result, including:
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regulatory authorities may withdraw approvals of such product and require F-stars approved product to be taken off the market, through a recall or other action; |
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regulatory authorities may require the addition of labeling statements or specific warnings, such as a black box warning or a contraindication, to the products prescribing information, or require field alerts to be sent to physicians and pharmacies; |
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regulatory authorities may require a medication guide explaining the risks of such side effects to be distributed to patients, or that F-star implement a risk evaluation and mitigation strategy plan to ensure that the benefits of the product outweigh its risks (such as through a REMS in the United States that may include a restricted distribution program or educational programs for prescribers); |
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F-star may be required to change the way the product is administered or to conduct additional clinical trials; |
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F-star may be subject to limitations on how it may promote the product; |
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sales of the product may decrease significantly; |
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F-star may be subject to litigation or product liability claims; and |
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F-stars reputation may suffer. |
Any of these events could prevent F-star, F-stars collaborators or F-stars potential future partners from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent it from generating significant revenue from the sale of its mAb2 product candidates, if approved.
F-star may find it difficult to enroll patients in F-stars clinical trials, which could delay or prevent it from proceeding with clinical trials of F-stars mAb2 product candidates.
Identifying and qualifying patients to participate in clinical trials of F-stars mAb2 product candidates is critical to F-stars success. The timing of F-stars clinical trials depends on F-stars ability to recruit eligible
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patients to participate as well as the completion of required follow-up evaluations. Patients may be unwilling to participate in F-stars clinical trials because of negative publicity from adverse events related to novel therapeutic approaches, competitive clinical trials for similar patient populations, the existence of current treatments or for other reasons including due to concerns posed by the COVID-19 pandemic. Enrollment risks are heightened with respect to indications that F-star may target in the future that may be rare or orphan diseases, which may limit the pool of patients that may be enrolled in F-stars planned clinical trials. Any delays related to patient enrollment could result in increased costs, delays in advancing F-stars mAb2 product candidates, delays in testing the effectiveness of F-stars mAb2 product candidates or termination of the clinical trials altogether. F-star may not be able to identify, recruit and enroll a sufficient number of patients, or those with the required or desired characteristics, to complete its clinical trials in a timely manner. Patient enrollment and trial completion is affected by many factors, including the:
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size and nature of the patient population and process for identifying patients; |
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proximity and availability of clinical trial sites for prospective patients; |
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eligibility and exclusion criteria for the trial; |
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design of the clinical trial; |
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safety profile, to date, of the mAb2 product candidate under study; |
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perceived risks and benefits of the mAb2 product candidate under study; |
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perceived risks and benefits of F-stars approach to treatment of diseases; |
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competition with other companies for clinical sites of patients; |
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severity of the disease under investigation; |
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degree of progression of the patients disease at the time of enrollment; |
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ability to obtain and maintain patient consent; |
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risk that enrolled patients will drop out before completion of the trial; |
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competing clinical trials and clinicians and patients perceptions as to the potential advantages of the mAb2 product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications F-star is investigating; |
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patient referral practices of physicians; and |
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ability to adequately monitor patients during and after treatment. |
F-star faces significant competition for its drug discovery and development efforts, and if F-star does not compete effectively, its commercial opportunities will be reduced or eliminated.
F-star competes in the segments of the biotechnology, pharmaceutical and other related markets that develop immuno-oncology therapies, and the market for biopharmaceutical products is highly competitive. F-stars competitors include many established pharmaceutical companies, biotechnology companies, universities and other research or commercial institutions, many of which have substantially greater financial, research and development resources than F-star. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, recruiting patients, obtaining regulatory approvals, manufacturing and marketing pharmaceutical products. Smaller and early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with it in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, the development of F-stars mAb2 product candidates. The fields in which F-star operates are characterized by rapid technological change and innovation.
There are many other companies that have commercialized and/or are developing immuno-oncology therapies for cancer including large biotechnology and pharmaceutical companies, such as AstraZeneca plc (AstraZeneca), BMS, Eli Lilly and Company (Eli Lilly), MSD, Merck KGaA (EMD Serono), Novartis, Pfizer, Inc. (Pfizer), Genentech, Inc. (Genentech), a subsidiary of the F. Hoffmann-La Roche AG Group
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(Roche) and Sanofi. A number of companies, not limited to those above, are attempting to combine immuno-oncology antibody therapies in order to modulate two cancer pathways simultaneously. Others have developed bispecific antibodies or bispecific fusion proteins in order to leverage the effect of a combination of single-target traditional monoclonal antibodies, which F-star refer to as traditional antibodies, in a single molecule.
With respect to F-stars mAb2 bispecific antibody pipeline, F-star is aware of a number of competitors using other technology methods to create bispecific antibodies to treat a variety of cancer types, including, but not limited to: Eli Lilly, Genmab A/S, Inhibrx, Inc. (Inhibrx), MacroGenics, Inc. (MacroGenics), Merus N.V. (Merus), Pieris Pharmaceuticals, Inc. (Pieris Pharmaceuticals), Roche and Xencor, Inc.
With respect to F-stars lead mAb2 product candidate, FS118, F-star is aware of other competing molecules targeting LAG-3 and PD-1/PD-L1 receptors. Companies pursuing a bispecific molecule include, but are not limited to: Avacta Group plc, Crescendo Biologics Ltd., GSK, Innovent Biologics (Innovent), Inc. Y-Biologics, MacroGenics and Hoffmann-La Roche. In addition, companies pursuing a combination of two traditional antibodies include, but are not limited to: BMS, C.H. Boehringer Sohn AG & Co. KG, GSK, MSD, Novartis/Immutep Limited, Incyte Corp (Incyte), Regeneron Pharmaceuticals, Inc. and Symphogen A/S, now a subsidiary of Servier Laboratories (Servier).
With respect to F-stars second mAb2 product candidate, FS120, F-star is aware of other competing bispecific antibodies targeting OX40 and CD137, which include Aptevo Therapeutics. F-star is also aware that Pfizer still has ongoing clinical studies evaluating a combination of CD137 plus OX40 traditional antibodies.
With respect to F-stars third mAb2 product candidate, FS222, F-star is aware of other competing bispecific antibodies targeting PD-L1 and CD137, which include Genmab/BioNTech SE, Inhibrx/Elpiscience, Merus/Incyte, Numab Therapeutics AG/CStone Pharmaceuticals, Pieris Pharmaceuticals/Servier, Shattuck Labs, I-mab Biopharma, Macrogenics, QLSF Biotherapeutics and Kahr Medical. F-star is aware of other companies pursuing a combination of two traditional antibodies targeting PD-1/PD-L1 and CD137, which include Lyvgen Biopharma (Suzhou)/MSD, Pfizer, and BMS.
F-star anticipates that it will continue to face increasing competition as new treatments enter the market and advanced technologies become available. There can be no assurance that F-stars competitors are not currently developing, or will not in the future develop, products that are equally or more effective or are safer, or are more economically attractive than any of F-stars current or future mAb2 product candidates, or platforms and technology that are superior to F-stars modular antibody technology platform and F-stars mAb2 technology. Competing products or technology platforms may gain faster or greater approval or market acceptance than F-stars mAb2 products, if any, or modular antibody technology platform and medical advances or rapid technological development by competitors may result in F-stars mAb2 product candidates or modular antibody technology platform becoming non-competitive or obsolete before F-star is able to recover F-stars research and development and commercialization expenses. If F-star, F-stars mAb2 product candidates or F-stars modular antibody technology platform do not compete effectively, it may have a material adverse effect on F-stars business, financial condition, and results of operations.
The regulatory approval processes of the FDA, the EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable, and if F-star is ultimately unable to obtain regulatory approval for F-stars mAb2 product candidates, F-stars business will be substantially harmed.
The time required to obtain approval by the FDA, the EMA and other comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, laws or regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidates clinical development and may vary among jurisdictions. F-star has not obtained regulatory approval for commercialization, for any mAb2 product candidate and it is possible that none of F-stars existing mAb2 product candidates or any mAb2 product candidates F-star may seek to develop in the future will ever obtain that approval.
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F-stars mAb2 product candidates could fail to receive regulatory approval for many reasons, including the following:
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The FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of F-stars clinical trials; |
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F-star may be unable to demonstrate to the satisfaction of the FDA, the EMA or other comparable foreign regulatory authorities that a mAb2 product candidate is safe, pure and potent or effective for its proposed indication; |
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the results of clinical trials may not meet the level of statistical significance required by the FDA, the EMA or other comparable foreign regulatory authorities for approval; |
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F-star may be unable to demonstrate that a mAb2 product candidates clinical and other benefits outweigh its safety risks; |
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the FDA, the EMA or other comparable foreign regulatory authorities may disagree with F-stars interpretation of data from preclinical studies or clinical trials; |
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the data collected from clinical trials of F-stars mAb2 product candidates may not be sufficient to support the submission of a Biologics License Application (BLA), to the FDA or other submission or to obtain regulatory approval in the United States, the EU or elsewhere; |
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upon review of F-star clinical trial sites and data, the FDA, EMA or comparable foreign regulatory authorities may find F-stars record keeping or the record keeping of its clinical trial sites to be inadequate; |
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the FDA, the EMA or other comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which F-star contract for clinical and commercial supplies; and |
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the approval policies or regulations of the FDA, the EMA or other comparable foreign regulatory authorities or the laws they enforce may significantly change in a manner rendering F-stars clinical data insufficient for approval. |
This lengthy approval process as well as the unpredictability of future clinical trial results may result in F-stars failing to obtain regulatory approval to market any of F-stars mAb2 product candidates, which would significantly harm F-stars business, financial condition and results of operations. The FDA, the EMA and other comparable foreign regulatory authorities have substantial discretion in the approval process, and determining when or whether to grant regulatory approval will be obtained for any of F-stars mAb2 product candidates, and whether to impose any conditions on such marketing approvals as described below. Even if F-star believes the data collected from clinical trials of F-stars mAb2 product candidates are promising, such data may not be sufficient to support approval by the FDA, the EMA or other comparable foreign regulatory authorities.
In addition, even if F-star were to obtain approval, regulatory authorities may approve any of F-stars mAb2 product candidates for fewer or more limited indications than F-star request, may not approve the price F-star intends to charge for F-stars mAb2 products, if any, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a mAb2 product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that mAb2 product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for F-stars mAb2 product candidates.
If F-star is required by the FDA to obtain approval of a companion diagnostic in connection with approval of a mAb2 product candidate, and F-star does not obtain or face delays in obtaining FDA approval of a diagnostic device, F-star will not be able to commercialize the mAb2 product candidate and F-stars ability to generate revenue will be materially impaired.
According to FDA guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product in an intent to treat indication, the FDA will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic is not also approved or cleared for that indication. Under the U.S. Federal Food, Drug, and Cosmetic Act, companion diagnostics are
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regulated as medical devices, and the FDA requires companion diagnostics intended to select the patients who likely will respond to cancer treatment to obtain Premarket Approval (PMA), for the diagnostic. The PMA process, including the gathering of analytical and prospective clinical data and the submission to and review by the FDA, involves a rigorous premarket review during which the applicant must prepare and provide the FDA with reasonable assurance of the devices safety and effectiveness and information about the device and its components regarding, among other things, device design, performance, good manufacturing practices, and labeling. A PMA is not guaranteed and may take considerable time, and the FDA may ultimately respond to a PMA submission with a not approvable determination based on deficiencies in the application and require additional clinical trial or other data that may be expensive and time-consuming to generate and that can substantially delay approval. As a result, if F-star is required by the FDA to obtain approval of a companion diagnostic for a therapeutic mAb2 product candidate, and F-star does not obtain or there are delays in obtaining FDA approval of a diagnostic device, F-star may not be able to commercialize the mAb2 product candidate on a timely basis or at all and F-stars ability to generate revenue will be materially impaired.
Even if F-stars mAb2 product candidates obtain regulatory approval, F-star will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense.
Additionally, F-stars mAb2 product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and F-star may be subject to penalties if F-star fails to comply with ongoing regulatory requirements or experiences unanticipated problems with any such approved products.
If the FDA, the EMA or other comparable foreign regulatory authority approves any of F-stars mAb2 product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the mAb2 product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, establishment registration, as well as continued compliance with current Good Manufacturing Practices (cGMPs), by all facilities involved in the production of the approved therapeutic product and with Good Clinical Practices (GCPs), for any clinical trials that F-star conducts post-approval, all of which may result in significant expense and limit F-stars ability to commercialize such products. In addition, any regulatory approvals that F-star receives for F-stars mAb2 product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the mAb2 product candidate. The FDA, as well as its foreign regulatory counterparts, also have significant post-market authority, including the authority to require labeling changes based on new safety information.
Moreover, the FDA strictly regulates the promotional claims that may be made about prescription drug and biological products. In particular, a product may not be promoted for off-label uses that are not approved by the FDA as reflected in the products approved packaging label. However, companies may share truthful and not misleading information that is otherwise consistent with a products FDA approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Further, if there are any modifications to the biologic, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new BLA or BLA supplement.
If there are changes in the application of legislation, regulations or regulatory policies, or if problems are discovered with a product or F-stars manufacture of a product, or if F-star or one of F-stars distributors, licensees or co-marketers fails to comply with regulatory requirements, regulatory authorities could take various actions. These include imposing fines on F-star, imposing restrictions on the product or its manufacture and requiring a recall or other removal of the product from the market. The regulators could also suspend or withdraw F-stars marketing authorizations, require it to conduct additional clinical trials, change F-stars product labeling or require F-star to submit additional applications for marketing authorization. If any of these events occurs, F-stars ability to sell such product may be impaired, and F-star may incur substantial additional expense to comply with regulatory requirements, which could materially adversely affect F-stars business, financial condition and results of operations.
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F-star may become exposed to costly and damaging liability claims, either when testing F-stars mAb2 product candidates in the clinic or at the commercial stage, and F-stars product liability insurance may not cover all damages from such claims.
F-star is exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of biopharmaceutical products. Currently, F-star has no products that have been approved for commercial sale; however, the current and future use of mAb2 product candidates by it and F-stars collaborators in clinical trials, and the potential sale of any approved products in the future, may expose it to liability claims. These claims might be made by patients who use the product, healthcare providers, pharmaceutical companies, F-stars collaborators or others selling such products. Any claims against F-star, regardless of their merit, could be difficult and costly to defend and could materially adversely affect the market for F-stars mAb2 product candidates or any prospects for commercialization of F-stars mAb2 product candidates. Although the clinical trial process is designed to identify and assess potential side effects, it is always possible that a product, even after regulatory approval, may exhibit unforeseen side effects. If any of F-stars mAb2 product candidates were to cause adverse side effects during clinical trials or after approval of the mAb2 product candidate, F-star may be exposed to substantial liabilities. Physicians and patients may not comply with any warnings that identify known potential adverse effects and patients who should not use F-stars mAb2 product candidates. Regardless of the merits or eventual outcome, liability claims may result in:
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decreased demand for F-stars products due to negative public perception; |
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injury to F-stars reputation; |
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withdrawal of clinical trial participants or difficulties in recruiting new trial participants; |
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initiation of investigations by regulators; |
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costs to defend or settle the related litigation; |
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a diversion of managements time and F-stars resources; |
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substantial monetary awards to trial participants or patients; |
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product recalls, withdrawals or labeling, marketing or promotional restrictions; |
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loss of revenues from product sales; and |
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the inability to commercialize any of F-stars mAb2 product candidates, if approved. |
Although F-star believes it maintains adequate product liability insurance for its mAb2 product candidates, it is possible that F-stars liabilities could exceed F-stars insurance coverage. F-star intends to expand F-stars insurance coverage to include the sale of commercial products if F-star obtains marketing approval for any of F-stars mAb2 product candidates. However, F-star may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise. If a successful product liability claim or series of claims is brought against it for uninsured liabilities or in excess of insured liabilities, F-stars assets may not be sufficient to cover such claims and F-stars business operations could be impaired.
Should any of the events described above occur, this could have a material adverse effect on F-stars business, financial condition and results of operations.
Due to F-stars limited resources and access to capital, F-star must, and has in the past decided to, prioritize development of certain mAb2 product candidates over other potential mAb2 product candidates. These decisions may prove to have been wrong and may adversely affect F-stars ability to develop its own programs, F-stars attractiveness as a commercial partner and may ultimately have an impact on F-stars commercial success.
Because F-star has limited resources and access to capital to fund its operations, F-star must decide which mAb2 product candidates to pursue and the amount of resources to allocate to each. F-stars decisions concerning the allocation of research, collaboration, management and financial resources toward particular mAb2 bispecific antibodies, mAb2 product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert resources away from better opportunities. Similarly, F-stars decisions to delay, terminate or collaborate with third parties in respect of certain product development programs may also prove not
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to be optimal and could cause it to miss valuable opportunities. If F-star makes incorrect determinations regarding the market potential of its mAb2 product candidates or misreads trends in the biopharmaceutical industry, in particular for F-stars lead mAb2 product candidate, F-stars business, financial condition and results of operations could be materially adversely affected.
F-star may seek orphan drug designation for mAb2 product candidates F-star develops, and F-star may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity if a designed product candidate is ultimately approved.
As part of F-stars business strategy, F-star may seek orphan drug designation for any mAb2 product candidates F-star develops, and F-star may be unsuccessful. Regulatory authorities in some jurisdictions, including the United States and the EU, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act in the United States, the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards certain clinical trial costs, tax advantages and user-fee waivers.
Similarly, in Europe, the European Commission grants orphan designation after receiving the opinion of the EMA Committee for Orphan Medicinal Products on an orphan designation application. Orphan designation is intended to promote the development of drugs that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5 in 10,000 persons in the EU and for which no satisfactory method of diagnosis, prevention, or treatment has been authorized (or the product would be a significant benefit to those affected). Additionally, designation is granted for drugs intended for the diagnosis, prevention, or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the EU would be sufficient to justify the necessary investment in developing the drug. In the EU, orphan designation entitles a party to a number of incentives, such as protocol assistance and scientific advice specifically for designated orphan medicines, and potential fee reductions depending on the status of the sponsor.
Generally in the United States, if a drug with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug and the same orphan indication for that time period, except in limited circumstances. The applicable period is seven years in the United States, with a potential six-month extension of exclusivity if certain pediatric studies are conducted and the results are reported to the FDA.
In Europe, an approved orphan medicinal product is entitled to ten years of market exclusivity in all EU member states. However, marketing authorization may be granted to a similar medicinal product with the same orphan indication during the ten-year period with the consent of the marketing authorization holder for the original orphan medicinal product or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities of such product. Marketing authorization may also be granted to a similar medicinal product with the same orphan indication if the similar product is established to be safer, more effective or otherwise clinically superior to the original orphan medicinal product. After five years, an EU member state can request that the period of market exclusivity be reduced to six years if it can be demonstrated that the criteria for orphan designation no longer apply and the medicine is sufficiently profitable. The period of market exclusivity may be extended for an additional two years for medicines that have also complied with an agreed pediatric investigation plan (PIP).
Similarly, even if F-star obtains orphan drug exclusivity for a mAb2 product candidate that is approved for marketing in the U.S., such exclusivity may not effectively protect the mAb2 product candidate from competition because different therapies can be approved for the same condition and the same therapies can be approved for different conditions but used off-label. Even after an orphan drug is approved, the FDA can subsequently approve the later drug for the same condition if the FDA concludes that the later drug is clinically superior in that
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it is shown to be safer, more effective or makes a major contribution to patient care. In addition, a designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. Moreover, orphan drug exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. While F-star may seek orphan drug designation for applicable indications for F-stars current and any future mAb2 product candidates, F-star may never receive such designations.
Accordingly, even if F-star does receive such designations in the U.S. and/or in Europe, there is no guarantee that F-star will enjoy the benefits of those designations.
F-stars approach to the discovery and development of F-stars therapeutic treatments is based on novel technologies that are unproven and may not result in marketable products.
F-star plans to develop a pipeline of mAb2 product candidates using F-stars modular antibody technology platform. F-star believes that mAb2 product candidates identified with its modular antibody technology platform may offer an improved therapeutic approach by creating fully formed molecules using standard antibody production technology, thereby potentially improving the binding and biological response, and reducing any need for reassembly or other post-synthesis modifications.
However, F-star has not, nor to F-stars knowledge has any other company, received regulatory approval for a therapeutic that uses tetravalent bispecific IgG1 antibody technology. F-star cannot be certain that its approach will lead to the development of approvable or marketable products. In addition, the FDA, the EMA or other comparable foreign regulatory agencies may lack experience in evaluating the safety and efficacy of products based on F-stars mAb2 technology, which could result in a longer than expected regulatory review process, increase F-stars expected development costs and delay or prevent commercialization of F-stars mAb2 product candidates.
F-star may not be successful in its efforts to utilize its modular antibody technology platform and mAb2 technology to build a pipeline of additional mAb2 product candidates. Failure to successfully identify, develop and commercialize additional products or mAb2 product candidates could impair F-stars ability to grow.
Although a substantial amount of F-stars efforts will continue to focus on the preclinical studies and clinical testing and potential approval of the mAb2 product candidates in F-stars current pipeline, a key element of F-stars long-term growth strategy is to identify, develop and market additional products and mAb2 product candidates. Because F-star has limited financial and managerial resources, continuing to utilize F-stars modular antibody technology platform and F-stars mAb2 technology to generate mAb2 bispecific antibodies and identify mAb2 product candidates with certain advantages, such as safety and potency, beyond what would be achieved with a combination of two traditional antibodies or bispecific antibodies, will require substantial additional technical, financial and human resources, whether or not any mAb2 product candidates are ultimately identified. F-stars modular antibody technology platform may fail to generate mAb2 bispecific antibodies that are suitable for further development, and F-star may fail to correctly identify future mAb2 product candidates that have the potential to become successful products. F-star will need to continue to invest in improving and expanding F-stars modular antibody technology platform and F-stars mAb2 technology, which will require scientific expertise and substantial resources.
All product candidates are prone to risks of failure typical of biopharmaceutical product development, including the possibility that a product candidate may not be suitable for clinical development as a result of its harmful side effects, limited efficacy or other characteristics that indicate that it is unlikely to be a product that will receive approval by the FDA, the EMA and other comparable foreign regulatory authorities and achieve market acceptance. If F-star does not successfully develop and commercialize F-stars mAb2 product candidates based upon F-stars current platform and technological approach, F-star may not be able to obtain product or collaboration revenues in future periods, which would adversely affect F-stars business, financial condition and results of operations.
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F-stars mAb2 product candidates that are successful in achieving marketing approval may face competition sooner than anticipated.
Even if F-star is successful in achieving regulatory approval to commercialize a mAb2 product candidate for a specific indication ahead of its competitors, such an approved therapeutic candidate may face competition from biosimilar products. In the United States, mAb2 product candidates are regulated by the FDA as biological products and F-star intends to seek approval for these therapeutic candidates pursuant to the BLA pathway. The BPCIA created an abbreviated pathway for the FDA approval of biosimilar biological products based on a previously licensed innovator, or reference, biological product. Under the BPCIA, an application for a biosimilar biological product cannot be approved by the FDA until 12 years after the original reference biological product was approved under a BLA.
F-star believes that any of its mAb2 product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity available to reference biological products. However, there is a risk that this exclusivity could be shortened due to Congressional action or otherwise, or that the FDA will not consider F-stars therapeutic candidates to be reference biological products pursuant to its interpretation of the exclusivity provisions of the BPCIA, potentially creating the opportunity for follow-on biosimilar competition sooner than anticipated. Moreover, the extent to which a biosimilar product, once approved, will be substituted for any reference product in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing including whether a future competitor seeks an interchangeability designation for a biosimilar of a future F-star approved biological products. Under the BPCIA as well as state pharmacy laws, only so-called interchangeable biosimilar products are considered substitutable for the reference biological product without the intervention of the healthcare provider who prescribed the original biological product. However, as with all prescribing decisions made in the context of a patient-provider relationship and a patients specific medical needs, healthcare providers are not restricted from prescribing biosimilar products in an off-label manner. In addition, a competitor could decide to forego the abbreviated approval pathway available for biosimilar products and to submit a full BLA for product licensure after completing its own preclinical studies and clinical trials. In such a situation, any exclusivity to which F-star may be eligible under the BPCIA would not prevent the competitor from marketing its biological product as soon as it is approved.
In Europe, the European Commission has granted marketing authorizations for several biosimilar products pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In addition, companies may be developing biosimilar products in other countries that could compete with F-stars products, if approved.
If competitors are able to obtain marketing approval for biosimilars referencing an approved F-star mAb2 product candidates, if approved, F-stars future products may become subject to competition from such biosimilars, whether or not they are designated as interchangeable, with the attendant competitive pressure and potential adverse consequences. Such competitive products may be able to immediately compete with F-star in each indication for which its product candidates may have received approval.
The successful commercialization of F-stars mAb2 product candidates will depend in part on the extent to which governmental authorities and health insurers establish coverage and adequate reimbursement levels, as well as pricing policies. Failure to obtain or maintain adequate coverage and reimbursement for F-stars mAb2 product candidates, if approved, could limit F-stars ability to market those products and decrease F-stars ability to generate revenue.
The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford products such as F-stars mAb2 product candidates, if approved. Even if F-star receives approval to market one or more of F-stars mAb2 product candidates in the future, F-stars ability to achieve acceptable levels of coverage and reimbursement for such mAb2 product candidates by governmental authorities, private health insurers and other organizations will have an effect on F-stars ability to successfully commercialize, and attract additional collaboration partners to invest in the development of, F-stars mAb2 product candidates. Assuming
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F-star obtains coverage for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. F-star cannot be sure that coverage and reimbursement in the United States, the EU or elsewhere will be available for any product that F-star may develop, and any reimbursement that may become available may be decreased or eliminated in the future.
Obtaining and maintaining reimbursement status is time-consuming and costly. No uniform policy for coverage and reimbursement for drug products exist among third-party payors in the United States. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require it to provide scientific and clinical support for the use of F-stars products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and F-star believes that changes in these rules and regulations are likely.
Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payors determination that use of a product is:
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a covered benefit under its health plan; |
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safe, effective and medically necessary; |
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appropriate for the specific patient; |
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cost-effective; and |
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neither experimental nor investigational. |
There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for F-stars mAb2 product candidates.
Third-party payors increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs when an equivalent generic/biosimilar drug or a less expensive therapy is available. It is possible that a third-party payor may consider F-stars mAb2 product candidate and other therapies as substitutable and only offer to reimburse patients for the less expensive product. Even if F-star shows improved efficacy or improved convenience of administration with F-stars mAb2 product candidate over other available and comparable products, pricing of existing drugs may limit the amount F-star will be able to charge for its mAb2 product candidate. These payors may deny or revoke the reimbursement status of a given drug product or establish prices for new or existing marketed products at levels that are too low to enable it to realize an appropriate return on F-stars investment in product development. If coverage and reimbursement is not available or is available only at limited levels, F-star may not be able to successfully commercialize F-stars mAb2 product candidates, and may not be able to obtain a satisfactory financial return on products that F-star may develop.
For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact physician utilization. For example, under these circumstances, physicians may limit how much or under what circumstances they will prescribe or administer F-stars products and patients may deliver to purchase such products. This, in turn, could affect F-stars ability to commercialize F-stars products successfully and impact F-stars profitability, results of operations, financial condition, and future success.
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Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and F-star believes the increasing emphasis on cost-containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of F-stars mAb2 product candidates. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own prices for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that F-star is able to charge for F-stars mAb2 product candidates. Accordingly, in markets outside the United States, the reimbursement for F-stars products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.
The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of healthcare and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of F-stars mAb2 product candidates, restrict or regulate post-approval activities and affect F-stars ability to commercialize any products for which F-star obtains marketing approval.
Moreover, increasing efforts by governmental and third-party payors in the United States, the EU and other jurisdictions to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for F-stars mAb2 product candidates. F-star expects to experience pricing pressures in connection with the sale of any of F-stars mAb2 product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.
The future commercial success of F-stars mAb2 product candidates will depend on the degree of market acceptance of F-stars potential products among physicians, patients, third-party payors and the medical community.
To date, F-star has no products authorized for marketing and F-star does not expect to be able to commercialize any of F-stars mAb2 product candidates for a number of years, if ever. Even if one or more of F-stars mAb2 product candidates are approved for commercialization, they may not achieve an adequate level of acceptance by physicians, patients and the medical community, and F-star may not become profitable. In addition, efforts to educate the medical community and third-party payors on the benefits of F-stars future approved products may require significant resources and may never be successful which would prevent F-star from generating significant revenues or becoming profitable. Market acceptance of F-stars future products by physicians, patients and third-party payors will depend on a number of factors, many of which are beyond F-stars control, including, but not limited to:
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the clinical indications for which F-stars mAb2 product candidates are approved; |
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physicians, hospitals, cancer treatment centers and patients considering F-stars mAb2 product candidates as a safe and effective treatment; |
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the potential and perceived advantages of F-stars mAb2 product candidates over alternative treatments; |
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the prevalence and severity of any side effects; |
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product labeling or product insert requirements of the FDA, the EMA or other comparable foreign regulatory authorities, or any risk mitigation measures that are required to be followed as part of the products marketing approval; |
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limitations or warnings contained in the labeling approved by the FDA, the EMA or other comparable foreign regulatory authorities; |
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the timing of market introduction of F-stars mAb2 product candidates in relation to other potentially competitive products; |
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the cost of F-stars mAb2 product candidates in relation to alternative treatments; |
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the amount of upfront costs or training required for physicians to administer F-stars mAb2 product candidates; |
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the availability of coverage and adequate reimbursement from third-party payors and government authorities; |
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the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and reimbursement by third-party payors and government authorities; |
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the relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; |
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the effectiveness of F-stars sales and marketing efforts and distribution support; and |
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the presence or perceived risk of potential product liability claims. |
If F-stars mAb2 product candidates fail to gain market acceptance, this will have a material adverse impact on F-stars ability to generate revenues to provide a satisfactory, or any, return on F-stars investments. Even if some products achieve market acceptance, the market may prove not to be large enough to allow it to generate significant revenues.
Healthcare legislative reform measures may have a negative impact on F-stars business and results of operations.
In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect F-stars ability to profitably sell any mAb2 product candidates for which F-star obtains marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact F-stars business in the future by requiring, for example: (i) changes to F-stars manufacturing arrangements, (ii) additions or modifications to product labeling, (iii) the recall or discontinuation of F-stars products, (iv) restriction on coverage, reimbursement, and pricing for F-stars products, (v) transparency reporting obligations regarding transfers of value to healthcare professionals or (vi) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect F-stars business, financial condition and results of operations.
In March 2010, the Affordable Care Act (ACA) was enacted, which includes measures that have significantly changed the way healthcare is financed by both governmental and private insurers in the United States. It also included the Biologics Price Competition and Innovation Act of 2009 (the BPCIA), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. The ACA continues to significantly impact the United States pharmaceutical industry. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and as a result certain sections of the law have not been fully implemented or effectively repealed. In particular, in December of 2018, a Texas U.S. District Court ruled that the ACA is unconstitutional in its entirety because the individual mandate was repealed by Congress as part of the Tax Cuts and Jobs Act, effective January 1, 2019. On December 18, 2019, the Fifth Circuit U.S. Court of Appeals upheld the District Court ruling that the individual mandate was unconstitutional, but remanded the case back to the lower court to determine whether other reforms enacted as part of the ACA but not specifically related to the individual mandate or health insurance, including the provisions comprising the BPCIA, could be severed from the rest of the ACA so as not to be declared invalid as well. On March 2, 2020, the United States Supreme Court granted the petitions for writs of certiorari to review this case and has allocated one hour for oral arguments, which are expected to occur in the fall, with a decision likely to follow in 2021. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. F-star will continue to evaluate the effect that the ACA and its possible repeal and replacement has on its business. Complying with any new legislation or reversing changes implemented under the ACA could be time-intensive and expensive, resulting in a material adverse effect on F-stars business.
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Other legislative changes have been proposed and adopted in the United States since the ACA was enacted that affect healthcare expenditures. In particular, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices and the manner in which manufacturers set prices for their marketed products. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, the current administrations budget for fiscal year 2021, as well as policies included in several executive orders issued by President Trump in late July 2020, contain further drug price control measures that could be enacted during the budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low income patients. Additionally, the current administration released a Blueprint to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of product candidates paid by consumers. The U.S. Department of Health and Human Services (HHS), has already started the process of soliciting feedback on some of these measures and, at the same time, is immediately implementing others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. This final rule codified CMSs policy change that was effective January 1, 2019.
The Further Consolidated Appropriations Act for 2020 (P.L. 116-94), signed into law in December 2019, included a piece of bipartisan legislation called the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (the CREATES Act). The CREATES Act aims to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic and biosimilar product developers access to samples of brand products. Because generic and biosimilar product developers need samples to conduct certain comparative testing required by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic and biosimilar products. To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary samples on commercially reasonable, market-based terms. Whether and how generic and biosimilar product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on F-stars future commercial products are unknown.
At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for F-stars products, once approved, or put pressure on F-stars product pricing.
F-star expects that these and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that F-star receive for any approved drug, which could have an adverse effect on customers for F-stars mAb2 product candidates. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.
In the EU, similar political, economic and regulatory developments may affect F-stars ability to profitably commercialize current or any future product candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in
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significant additional requirements or obstacles that may increase F-stars operating costs. In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.
There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, U.S. federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The implementation of cost containment measures or other healthcare reforms may prevent F-star from being able to generate revenue, attain profitability, or commercialize F-stars products. Such reforms could have an adverse effect on anticipated revenue from mAb2 product candidates that F-star may successfully develop and for which F-star may obtain regulatory approval and may affect F-stars overall financial condition and ability to develop mAb2 product candidates.
F-stars business operations and current and future relationships with clinical investigators, healthcare professionals, consultants, third-party payors and customers may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws. If F-star is unable to comply, or has not fully complied, with such laws, F-star could face substantial penalties.
Although F-star does not currently have any products on the market, F-stars current and future operations may be directly, or indirectly through F-stars relationships with clinical investigators, healthcare professionals, customers and third-party payors, subject to broadly applicable healthcare laws U.S. federal and state fraud and abuse and other healthcare laws and regulations, including, without limitation, the Anti-Kickback Statute. Healthcare providers, physicians and others play a primary role in the recommendation and prescription of any products for which F-star obtains marketing approval. These laws impact, among other things, F-stars proposed sales, marketing and education programs and constrain F-stars business and financial arrangements and relationships with third-party payors, healthcare professionals who participate in F-stars clinical research program, healthcare professionals and others who recommend, purchase, or provide F-stars approved products, and other parties through which F-star market, sell and distribute F-stars products for which F-star obtains marketing approval. In addition, F-star may be subject to patient data privacy and security regulation by both the U.S. federal government and the states in which F-star conducts F-stars business. Finally, F-stars current and future operations are subject to additional healthcare-related statutory and regulatory requirements and enforcement by foreign regulatory authorities in jurisdictions in which F-star conducts F-stars business.
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the Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act, (FCA); |
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federal civil and criminal false claims laws and civil monetary penalty laws, including the FCA, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs, knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation to pay money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to cause the submission of false or fraudulent claims. The FCA also permits a private individual acting as a whistleblower to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery; |
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HIPAA, which created new federal criminal and civil statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; |
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HIPAA, as amended by HITECH, and their implementing regulations, which impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information by covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers, as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information and require notification to affected individuals and regulatory authorities of certain breaches of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys fees and costs associated with pursuing federal civil actions; |
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federal legislation commonly referred to as Physician Payments Sunshine Act, enacted as part of the ACA, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Childrens Health Insurance Program to report annually to the CMS information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists, chiropractors and, beginning in 2022 for payments and other transfers of value provided in the previous year, certain advanced non-physician healthcare practitioners) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; |
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analogous state laws and regulations, including: state anti-kickback and false claims laws that may apply to claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industrys voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral source; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; state and local laws that require the registration of pharmaceutical sales representatives; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and |
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European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers. |
The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products and to limit the distribution of product samples and impose requirements to ensure accountability in prescription drug sample distribution.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.
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It is possible that governmental authorities will conclude that F-stars business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws. If F-stars operations are found to be in violation of any of these laws or any other laws that may apply to F-star, F-star may be subject to significant sanctions, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if F-star become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm and the curtailment or restructuring of F-stars operations. If any of the physicians or other healthcare providers or entities with whom F-star expects to do business is found not to be in compliance with applicable laws, that person or entity may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.
The risk of it being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts or otherwise have broad coverage. For example, the definition of the remuneration under the Anti-Kickback Statute has been interpreted to include anything of value. Further, courts have found that if one purpose of remuneration is to induce referrals, the Anti-Kickback Statute is violated.
Efforts to ensure that F-stars business arrangements with third parties will comply with applicable healthcare laws will involve substantial costs. Any action against it for violation of these laws, even if F-star successfully defends against it, could cause it to incur significant legal expenses and divert F-stars managements attention from the operation of F-stars business. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance or reporting requirements increases the possibility that a biopharmaceutical company may run afoul of one or more of the requirements.
Obtaining and maintaining marketing approval of F-stars current and future mAb2 product candidates in one jurisdiction does not mean that F-star will be successful in obtaining marketing approval of its current and future mAb2 product candidates in other jurisdictions.
Obtaining and maintaining marketing approval of F-stars current and future mAb2 product candidates in one jurisdiction does not guarantee that F-star will be able to obtain or maintain marketing approval in any other jurisdiction, while a failure or delay in obtaining marketing approval in one jurisdiction may have a negative effect on the marketing approval process in others. For example, even if the FDA grants marketing approval of a mAb2 product candidate, comparable foreign regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the mAb2 product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that F-star intends to charge for F-stars future products will also be subject to approval.
F-star may submit marketing applications in other countries in addition to the United States. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which F-star must comply prior to marketing in those jurisdictions. Obtaining foreign marketing approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for F-star and could delay or prevent the introduction of F-stars products in certain countries. If F-star fails to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, F-stars target market will be reduced and F-stars ability to realize the full market potential of F-stars mAb2 product candidates will be harmed.
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F-star has never commercialized a mAb2 product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize F-stars products on its own or together with suitable partners.
F-star does not have a sales or marketing infrastructure and has no experience in the sale or marketing of biopharmaceutical products. To achieve commercial success for any approved product, F-star must develop or acquire a sales and marketing organization, outsource these functions to third parties or enter into partnerships.
F-star may decide to establish its own sales and marketing capabilities and promote its mAb2 product candidates if and when regulatory approval has been obtained in the United States and the major EU countries. There are risks involved if F-star decides to establishes F-stars own sales and marketing capabilities or enter into arrangements with third parties to perform these services. Even if F-star establish sales and marketing capabilities, F-star may fail to launch F-stars products effectively or to market F-stars products effectively since F-star has no experience in the sales and marketing of biopharmaceutical products. In addition, recruiting and training a sales force is expensive and time consuming and could delay any product launch. In the event that any such launch is delayed or does not occur for any reason, F-star would have prematurely or unnecessarily incurred these commercialization expenses, and F-stars investment would be lost if F-star cannot retain or reposition F-stars sales and marketing personnel. Factors that may inhibit F-stars efforts to commercialize F-stars products on F-stars own include:
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F-stars inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; |
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the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe F-stars products; |
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the lack of complementary products to be offered by sales personnel, which may put F-star at a competitive disadvantage relative to companies with more extensive product lines; |
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unforeseen costs and expenses associated with creating an independent sales and marketing organization; and |
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costs of marketing and promotion above those anticipated by F-star. |
If F-star enters into arrangements with third parties to perform sales and marketing services, F-stars product revenues or the profitability of these product revenues to it could be lower than if F-star were to market and sell any products that F-star develops itself. Such collaborative arrangements with partners may place the commercialization of F-stars products outside of F-stars control and would make it subject to a number of risks including that F-star may not be able to control the amount or timing of resources that F-stars collaborative partner devotes to F-stars products or that F-stars collaborators willingness or ability to complete its obligations, and F-stars obligations under F-stars arrangements may be adversely affected by business combinations or significant changes in F-stars collaborators business strategy. In addition, F-star may not be successful in entering into arrangements with third parties to sell and market F-stars products or may be unable to do so on terms that are favorable to F-star. Acceptable third parties may fail to devote the necessary resources and attention to sell and market F-stars products effectively.
If F-star does not establish sales and marketing capabilities successfully, either on F-stars own or in collaboration with third parties, F-star may not be successful in commercializing F-stars products, which in turn would have a material adverse effect on F-stars business, financial condition and results of operations.
Adverse events in the field of immuno-oncology could damage public perception of F-stars current or future mAb2 product candidates and negatively affect F-stars business.
The commercial success of F-stars immuno-oncology mAb2 product candidates, if approved, will depend in part on public acceptance of the use of cancer immunotherapies. Adverse events in marketed products, in clinical trials of F-stars mAb2 product candidates or in clinical trials of others developing similar products and the resulting publicity, as well as any other adverse events in the field of immuno-oncology that may occur in the future, could result in a decrease in demand for any products that F-star may develop. If public perception is influenced by claims that the use of cancer immunotherapies is unsafe, whether related to F-stars products or
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those of F-stars competitors, F-stars products may not be accepted by the general public or the medical community.
Future adverse events in immuno-oncology or the biopharmaceutical industry could also result in heightened governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of F-stars mAb2 product candidates. Any increased scrutiny could delay or increase the costs of obtaining marketing approval for the mAb2 product candidates F-star develops or prevent it from receiving marketing approval at all.
The market opportunities for any current or future immuno-oncology mAb2 product candidates F-star develops, if approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
Cancer therapies are sometimes characterized as first-line, second-line or third-line, and the FDA often approves new therapies initially only for third-line use. When cancer is detected early enough, first-line therapy, usually chemotherapy, hormone therapy, surgery, radiation therapy or a combination of these, is sometimes adequate to cure the cancer or prolong life without a cure. Second- and third-line therapies are administered to patients when prior therapy is not effective. F-star expects to initially seek approval of F-stars current and future immuno-oncology mAb2 product candidates as a therapy for patients who have received one or more prior treatments. Subsequently, for those products that prove to be sufficiently beneficial, if any, F-star would expect to seek approval potentially as a first-line therapy, but there is no guarantee that mAb2 product candidates F-star develops, even if approved, would be approved for first-line therapy, and, prior to any such approvals, F-star may have to conduct additional clinical trials.
In addition, subsequent developments in cancer biomarkers may demonstrate that F-stars mAb2 product candidates are not suitable for the treatment of certain cancers or subpopulations, thereby reducing the market opportunity for those mAb2 product candidates. Even if F-star obtains significant market share for any mAb2 product candidate, if approved, if the potential target populations are small, F-star may never achieve profitability without obtaining marketing approval for additional indications, including to be used as first- or second-line therapy or for other related cancer indications.
If the market opportunities for F-stars mAb2 product candidates are smaller than F-star believes they are, even assuming approval of a mAb2 product candidate, F-stars business may suffer.
F-stars projections of both the number of people who are affected by disease within F-stars potential target indications, as well as the subset of these people who have the potential to benefit from treatment with F-stars mAb2 product candidates, are based on F-stars beliefs and estimates. These estimates have been derived from a variety of sources, including the scientific literature, healthcare utilization databases and market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. Likewise, the potentially addressable patient population for each of F-stars mAb2 product candidates may be limited or may not be amenable to treatment with F-stars mAb2 product candidates, and new patients may become increasingly difficult to identify or gain access to, which would adversely affect F-stars business, financial condition and results of operations.
A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect F-stars business and financial results and could cause a disruption to the development of its product candidates.
Public health crises such as pandemics or similar outbreaks could adversely impact F-stars business. Recently, COVID-19 has spread across the United States and in other countries, including specifically Cambridge, U.K., where F-stars primary office and laboratory space is located. The coronavirus pandemic is evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures. The extent to which the novel coronavirus impacts F-stars operations or those of its third-party collaborators and partners, including F-stars preclinical studies or clinical trial operations, will depend on future developments, which are highly uncertain
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and cannot be predicted with confidence, including the duration of the outbreak, new information that will emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. The continued spread of COVID-19 globally could adversely impact F-stars preclinical or clinical trial operations, including its ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs in their geography. For example, similar to other biopharmaceutical companies, F-star may experience delays in initiating preclinical studies, enrolling its clinical trials, or dosing of patients in its clinical trials as well as in activating new trial sites. COVID-19 may also affect employees of third-party CROs located in affected geographies that F-star relies upon to carry out clinical trials. Any negative impact COVID-19 has to patient enrollment or treatment or the execution of F-stars product candidates could cause costly delays to clinical trial activities, which could adversely affect F-stars ability to obtain regulatory approval for and to commercialize F-stars product candidates, increase F-stars operating expenses, and have a material adverse effect on F-stars financial results.
Additionally, timely enrollment in planned clinical trials is dependent upon clinical trial sites that could be adversely affected by global health matters, such as pandemics. F-star plans to conduct clinical trials for its mAb2 product candidates in geographies that are currently being affected by the COVID-19. Some factors from the novel coronavirus outbreak that will delay or otherwise adversely affect enrollment in the clinical trials of its mAb2 product candidates, as well as F-stars business generally, include:
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the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, including the attention of physicians serving as F-stars clinical trial investigators, hospitals serving as F-stars clinical trial sites and hospital staff supporting the conduct of F-stars prospective clinical trials; |
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limitations on travel that could interrupt key trial and business activities, such as clinical trial site initiations and monitoring, domestic and international travel by employees, contractors or patients to clinical trial sites, including any government-imposed travel restrictions or quarantines that will impact the ability or willingness of patients, employees or contractors to travel to F-stars clinical trial sites or secure visas or entry permissions, a loss of face-to-face meetings and other interactions with potential partners, any of which could delay or adversely impact the conduct or progress of F-stars prospective clinical trials; |
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the potential negative affect on the operations of F-stars third-party manufacturers; |
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interruption in global shipping affecting the transport of clinical trial materials, such as patient samples, investigational drug product and conditioning drugs and other supplies used in F-stars prospective clinical trials; and |
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business disruptions caused by potential workplace, laboratory and office closures and an increased reliance on employees working from home, disruptions to or delays in ongoing laboratory experiments. |
Risks Related to F-stars Intellectual Property
F-star relies on patents and other intellectual property rights to protect its mAb2 product candidates and F-stars modular antibody technology platform, the enforcement, defense and maintenance of which may be challenging and costly. Failure to protect or enforce these rights adequately could harm F-stars ability to compete and impair F-stars business.
F-stars commercial success depends in part on obtaining and maintaining patents and other forms of intellectual property rights for F-stars mAb2 product candidates, methods used to manufacture those mAb2 product candidates and the methods for treating patients using those mAb2 product candidates, or on in-licensing such rights. Failure to protect or to obtain, maintain or extend adequate patent and other intellectual property rights could materially adversely affect F-stars ability to develop and market F-stars products and mAb2 product candidates.
Patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications, and then only to the extent the issued claims cover the technology at issue. F-star cannot be certain that patents will be issued or granted with respect to
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applications that are currently pending, or that issued or granted patents will not later be found to be invalid or enforceable. The patent position of biopharmaceutical companies is generally uncertain because it involves complex legal and factual considerations that have in recent years been the subject of much litigation. The standards applied by the European Patent Office (EPO), the U.S. Patent and Trademark Office (USPTO), and foreign patent offices in granting patents are not always applied uniformly or predictably. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in biopharmaceutical patents. Consequently, patents may not issue from F-stars pending patent applications. As such, F-star does not know the degree of future protection that it will obtain that covers its proprietary mAb2 product candidates and modular antibody technology platform. The scope of patent protection that the EPO and the USPTO will grant with respect to the bispecific antibodies in F-stars product pipeline is uncertain. It is possible that the EPO and the USPTO will not allow broad antibody claims that cover antibodies closely related to F-stars mAb2 product candidates as well as the specific antibody. As a result, upon receipt of EMA or FDA approval, competitors may be free to market antibodies almost identical to F-stars, including biosimilar antibodies, thereby decreasing F-stars market share. However, a competitor cannot submit to the FDA an application for a biosimilar product based on one of F-stars products until four years following the date of approval of F-stars reference product, and the FDA may not approve such a biosimilar product until 12 years from the date on which the reference product was approved, with a potential six-month extension of exclusivity if certain pediatric studies are conducted and the results are reported to the FDA.
The patent prosecution process is expensive and time-consuming, and F-star and its current or future licensors, licensees or collaboration partners may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that F-star or its licensors, licensees or collaboration partners will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Further, the issuance, scope, validity, enforceability and commercial value of F-stars and F-stars current or future licensors, licensees or collaboration partners patent rights are highly uncertain. F-stars pending and future patent applications may not result in patents being issued which protect F-stars modular antibody technology platform or F-stars mAb2 product candidates, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. F-stars competitors may be able to circumvent F-stars patents by developing similar or alternative product candidates in a non-infringing manner. Moreover, in some circumstances, F-star may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that F-star license from or license to third parties and are reliant on F-stars licensors, licensees or collaboration partners. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of F-stars business. If F-stars current or future licensors, licensees or collaboration partners fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If F-stars current or future licensors, licensees or collaboration partners are not fully cooperative or disagree with it as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. The patent examination process may require it or F-stars current or future licensors, licensees or collaboration partners to narrow the scope of the claims of F-stars or F-stars licensors, licensees or collaboration partners pending and future patent applications, which may limit the scope of patent protection that may be obtained.
F-star cannot assure you that all of the potentially relevant prior art relating to F-stars patents and patent applications has been found. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, F-star cannot know with certainty whether it was the first to make the inventions claimed in F-stars patents or pending patent applications, or that F-star was the first to file for patent protection of such inventions. If such prior art exists, it can invalidate a patent or prevent a patent from issuing from a pending patent application. Furthermore, if third parties have filed such patent applications on or before March 15, 2013, an interference proceeding can be initiated by such third parties to determine who was the first to invent any of the subject matter covered by the patent claims of F-stars applications. If third parties have filed such applications after March 15, 2013, a derivation proceeding can be initiated by such third parties to determine whether F-stars invention was derived from theirs. Even where F-star
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has a valid and enforceable patent, F-star may not be able to exclude others from practicing F-stars invention where the other party can show that they used the invention in commerce before F-stars filing date or the other party benefits from a compulsory license.
F-star has pending patent applications at the USPTO, the EPO, and the patent offices of other foreign jurisdictions, and it is possible that F-star will need to defend other patents from challenges by others from time to time. Certain of F-stars U.S. patent applications have been and may in the future be the subject of submissions of prior art by third parties. Even if patents do successfully issue, third parties may initiate an opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation action in court or before patent offices, or similar proceedings challenging the validity, enforceability or scope of such patents, which may result in the patent claims being narrowed, invalidated, or held unenforceable, in whole or in part. For example, opposition proceedings at the EPO are increasingly common, and are costly and time consuming to defend. Similar proceedings are available in other patent offices around the world. It is possible that one or more of F-stars U.S. patents may be challenged by parties who file a request for post-grant review or inter partes review or ex parte reexamination. Post-grant proceedings are increasingly common in the United States and are costly to defend. F-stars patent rights may not provide it with a proprietary position or competitive advantages against competitors. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, F-stars patent rights, allow third parties to commercialize F-stars mAb2 product candidates and compete directly with F-star, without payment to F-star, or result in F-stars inability to manufacture or commercialize drugs without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by F-stars patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with it to license, develop or commercialize current or future mAb2 product candidates. Furthermore, even if the outcome is favorable to F-star, the enforcement of F-stars intellectual property rights can be extremely expensive and time consuming.
F-star may become involved in lawsuits to protect or enforce F-stars patents or other intellectual property, which could be expensive, time consuming and unsuccessful, and issued patents covering one or more of F-stars mAb2 product candidates or F-stars modular antibody technology platform could be found invalid or unenforceable if challenged in court.
To protect F-stars competitive position, F-star may from time to time need to resort to litigation in order to enforce or defend any patents or other intellectual property rights owned by or licensed to F-star, or to determine or challenge the scope or validity of patents or other intellectual property rights of third parties. As enforcement of intellectual property rights is difficult, unpredictable and expensive, and many of F-stars or F-stars collaboration partners adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than F-star or F-stars collaboration partners can. Accordingly, despite F-stars or F-stars collaboration partners efforts, F-star or F-stars collaboration partners may not prevent third parties from infringing upon or misappropriating intellectual property rights F-star own or control, particularly in countries where the laws may not protect those rights as fully as in the United States and the EU. F-star may fail in enforcing F-stars rights, in which case F-stars competitors may be permitted to use F-stars technology without being required to pay it any license fees. In addition, however, litigation involving F-stars patents carries the risk that one or more of F-stars patents will be held invalid (in whole or in part, on a claim-by-claim basis) or held unenforceable. Such an adverse court ruling could allow third parties to commercialize F-stars mAb2 product candidates or use F-stars modular antibody technology platform, and then compete directly with F-star, without payment to F-star.
If F-star were to initiate legal proceedings against a third party to enforce a patent covering one of F-stars products, the defendant could counterclaim that F-stars patent is invalid or unenforceable. In patent litigation in the United States or in Europe, defendant counterclaims alleging invalidity or unenforceability are commonplace. A claim for a validity challenge may be based on failure to meet any of several statutory requirements, for example, lack of novelty, obviousness or non-enablement. A claim for unenforceability assertion could be an allegation that someone connected with prosecuting the patent withheld relevant information from the USPTO or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable. With respect to the validity question, for example,
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F-star cannot be certain that there is no invalidating prior art, of which F-star and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, F-star would lose at least part, and perhaps all, of the patent protection on one or more of F-stars mAb2 product candidates or certain aspects of F-stars modular antibody technology platform. Such a loss of patent protection could have a material adverse impact on F-stars business. Interference or derivation proceedings provoked by third parties or brought by it or declared by the USPTO may be necessary to determine the priority of inventions with respect to F-stars patents or patent applications. An unfavorable outcome could require it to cease using the related technology or to attempt to license rights to it from the prevailing party. F-stars business could be harmed if the prevailing party does not offer it a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and F-stars competitors gain access to the same technology. Further, litigation could result in substantial costs and diversion of management resources, regardless of the outcome, and this could harm F-stars business and financial results. Patents and other intellectual property rights also will not protect F-stars technology if competitors design around F-stars protected technology without infringing F-stars patents or other intellectual property rights. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of F-stars confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of the combined companys common stock.
Intellectual property rights of third parties could adversely affect F-stars ability to commercialize F-stars mAb2 product candidates, such that F-star could be required to litigate or obtain licenses from third parties in order to develop or market F-stars mAb2 product candidates. Such litigation is, and will continue to be, costly and any required licenses may not available on commercially reasonable terms.
Third-party claims of intellectual property infringement may prevent or delay F-stars development and commercialization efforts. F-stars commercial success depends in part on F-stars avoiding infringement of the patents and proprietary rights of third parties. However, F-stars research, development and commercialization activities may be subject to claims that F-star infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, derivation proceedings, oppositions and inter partes reexamination proceedings before the USPTO, and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which F-star is pursuing development candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that F-star may be subject to claims of infringement of the patent rights of third parties.
F-stars competitive position may suffer if patents issued to third parties or other third-party intellectual property rights cover F-stars products or elements thereof, F-stars manufacture or uses relevant to F-stars development plans, the targets of F-stars mAb2 product candidates, or other attributes of F-stars mAb2 product candidates or F-stars mAb2 technology. In such cases, F-star may not be in a position to develop or commercialize products or mAb2 product candidates unless F-star successfully pursue litigation to nullify or invalidate the third-party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms or at all.
It is also possible that F-star fails to identify relevant patents or patent applications. For example, certain U.S. applications filed after November 29, 2000 that will not be filed outside the United States may remain confidential until issuance of a patent. In general, patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering F-stars products or platform technology could have been filed by others without F-stars knowledge. Furthermore, F-star operates in a highly competitive field, and given F-stars limited resources, it is unreasonable to monitor all patent applications purporting to gain broad coverage in the areas in which F-star is active. Additionally, pending patent
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applications which have been published can, subject to certain limitations, be later amended in a manner that could cover F-stars platform technologies, F-stars products or the use of F-stars products.
Parties making claims of infringement against it or defending against F-stars invalidity actions may be able to sustain the costs of complex patent litigation more effectively than F-star can because they have substantially greater resources. If F-star fails in any such dispute, in addition to being forced to pay damages, F-star or F-stars licensees may be temporarily or permanently prohibited from commercializing any of F-stars mAb2 product candidates that are held to be infringing. F-star might, if possible, also be forced to redesign mAb2 product candidates so that F-star no longer infringe the third-party intellectual property rights. Or, F-star may be required to seek a license to any such technology that F-star is found to infringe, which license may not be available on commercially reasonable terms, or at all. Even if F-star or F-stars collaboration partners obtain a license, it may be non-exclusive; thereby giving F-stars competitors access to the same technologies licensed to it or F-stars licensors or collaboration partners. Moreover, such a license may require F-star to pay royalties to the licensor; thus reducing F-stars expected revenues. In addition, F-star could be found liable for monetary damages, including treble damages and attorneys fees, if F-star is found to have willfully infringed a patent in the United States. Any of these events, even if F-star were ultimately to prevail, could require it to divert substantial financial and management resources that F-star would otherwise be able to devote to F-stars business.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, F-star could have a substantial adverse effect on F-stars share price. Such litigation or proceedings could substantially increase F-stars operating losses and reduce F-stars resources available for development activities. F-star may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of F-stars competitors may be able to sustain the costs of such litigation or proceedings more effectively than F-star can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on F-stars ability to compete in the marketplace.
In addition, if the breadth or strength of protection provided by F-stars or F-stars collaboration partners patents and patent applications is threatened, it could dissuade companies from collaborating with F-star to license, develop or commercialize current or future mAb2 product candidates. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of F-stars confidential information could be compromised by disclosure during this type of litigation.
If F-star fails to comply with its obligations in the agreements under which F-star licenses intellectual property rights from third parties or otherwise experience disruptions to F-stars business relationships with F-stars licensors, F-star could lose intellectual property rights that are important to F-stars business.
F-star is a party to license agreements, and F-star may in the future need to obtain additional licenses from others to advance F-stars research and development activities or allow the commercialization of F-stars mAb2 product candidates. F-stars current license agreements impose, and F-star expects that future license agreements will impose, various development, diligence, commercialization and other obligations on F-star. In spite of F-stars efforts, F-stars current or future licensors might conclude that F-star has materially breached F-stars obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting F-stars ability to develop and commercialize mAb2 product candidates and otherwise use technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties would have the freedom to seek regulatory approval of, and to market, products identical to F-stars and F-star may be required to cease F-stars development and commercialization of F-stars mAb2 product candidates. Any of the foregoing could have a material adverse effect on F-stars competitive position, business, financial conditions, results of operations, and prospects.
Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including:
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the scope of rights granted under the license agreement and other interpretation-related issues; |
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the extent to which F-stars mAb2 product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
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the sublicensing of patent and other rights under F-stars collaborative development relationships; |
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F-stars diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by F-stars licensors F-star and F-stars partners; and |
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the priority of invention of patented technology. |
In addition, the agreements under which F-star currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what F-star believes to be the scope of F-stars rights to the relevant intellectual property or technology, or increase what F-star believes to be its financial or other obligations under the relevant agreement, either of which could have a material adverse effect on F-stars business, financial condition, results of operations, and prospects. Moreover, if disputes over intellectual property that F-star has licensed prevent or impair F-stars ability to maintain F-stars current licensing arrangements on commercially acceptable terms, F-star may be unable to successfully develop and commercialize the affected mAb2 product candidates, which could have a material adverse effect on F-stars business, financial conditions, results of operations, and prospects.
F-star may not be successful in obtaining or maintaining necessary rights to F-stars mAb2 product candidates through acquisitions and in-licenses.
Because F-stars programs may require the use of proprietary rights held by third parties, the growth of F-stars business will likely depend in part on F-stars ability to acquire or in-license such proprietary rights. F-star may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property rights from third parties that F-star identifies as necessary for F-stars mAb2 product candidates. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies may pursue strategies to license or acquire third-party intellectual property rights that F-star may consider attractive. These established companies may have a competitive advantage over F-star due to their size, cash resources and greater clinical development and commercialization capabilities.
In addition, companies that perceive it to be a competitor may be unwilling to assign or license rights to F-star. F-star also may be unable to license or acquire third-party intellectual property rights on terms that would allow F-star to make an appropriate return on F-stars investment. If F-star is unable to successfully obtain a license to third-party intellectual property rights necessary for the development of a mAb2 product candidate or program, F-star may have to abandon development of that mAb2 product candidate or program, and F-stars business and financial condition could suffer.
If F-stars trademarks and trade names are not adequately protected, then F-star may not be able to build name recognition in F-stars markets of interest and F-stars business may be adversely affected.
F-stars registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. F-star may not be able to protect F-stars rights to these trademarks and trade names, which F-star need to build name recognition by potential partners or customers in F-stars markets of interest. Over the long term, if F-star is unable to establish name recognition based on F-stars trademarks and trade names, then F-star may not be able to compete effectively and F-stars business may be adversely affected. If other entities use trademarks similar to F-stars in different jurisdictions, or have senior rights to F-stars, it could interfere with F-stars use of F-stars current trademarks throughout the world.
If F-star does not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering each of F-stars mAb2 product candidates, F-stars business may be materially harmed.
Patents have a limited duration. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions
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may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering F-stars mAb2 product candidates, their manufacture or use are obtained, once the patent life has expired, F-star may be open to competition from competitive medications, including biosimilar medications. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, F-stars owned and in-licensed patent portfolio may not provide it with sufficient rights to exclude others from commercializing products similar or identical to F-stars.
Depending upon the timing, duration and conditions of FDA marketing approval of F-stars mAb2 product candidates, one or more of F-stars U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act and similar legislation in the EU. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. The patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent applicable to an approved drug may be extended. Patent term extension also may be available in certain foreign countries upon regulatory approval of F-stars mAb2 product candidates. However, F-star may not receive an extension if F-star fails to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension, as well as the scope of the protection during such an extension, could be less than F-star request. If F-star is unable to obtain patent term extension or the term of any such extension is less than F-star request, the period during which F-star can enforce F-stars patent rights for that product will be shortened and F-stars competitors may obtain approval to market competing products sooner than F-star expects. As a result, F-stars revenue from applicable products could be reduced, possibly materially.
F-star enjoys only limited geographical protection with respect to certain patents and may face difficulties in certain jurisdictions, which may diminish the value of intellectual property rights in those jurisdictions.
F-star often files its first patent application (i.e., priority filing) in Great Britain or with the USPTO. International applications under the Patent Cooperation Treaty (PCT), are usually filed within 12 months after the priority filing. Based on the PCT filing, national and regional patent applications may be filed in additional jurisdictions where F-star believes its mAb2 product candidates may be marketed. F-star has so far not filed for patent protection in all national and regional jurisdictions where such protection may be available. In addition, F-star may decide to abandon national and regional patent applications before grant. Finally, the grant proceeding of each national/regional patent is an independent proceeding which may lead to situations in which applications might be refused by certain patent offices, while granted by others, and the scope of patent protection may vary for the same mAb2 product candidate or technology.
Competitors may use F-stars and its collaboration partners technologies in jurisdictions where F-star has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where F-star and F-stars licensors or collaboration partners have patent protection, but enforcement is not as strong as that in the United States and the EU. These products may compete with F-stars mAb2 product candidates, and F-stars and F-stars collaboration partners patents or other intellectual property rights may not be effective or sufficient to prevent them from competing with F-star.
The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws in the United States and the EU, and companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. If F-star encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for F-stars business in such jurisdictions, the value of these rights may be diminished, and F-star may face additional competition from others in those jurisdictions.
Some countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, some countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could
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materially diminish the value of such patent. If F-star or any of F-stars licensors are forced to grant a license to third parties with respect to any patents relevant to F-stars business, F-stars competitive position may be impaired and F-stars business and results of operations may be adversely affected.
Proceedings to enforce F-stars and F-stars collaboration partners patent rights in foreign jurisdictions could result in substantial costs and divert F-stars and F-stars collaboration partners efforts and attention from other aspects of F-stars business, could put F-stars and F-stars collaboration partners patents at risk of being invalidated or interpreted narrowly and F-stars and F-stars collaboration partners patent applications at risk of not issuing and could provoke third parties to assert claims against it or F-stars licensors or collaboration partners. F-star or F-stars collaboration partners may not prevail in any lawsuits that F-star or F-stars licensors or collaboration partners initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, F-stars efforts to enforce F-stars intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that F-star develops or license.
Intellectual property rights do not necessarily address all potential threats to F-stars competitive advantage.
The degree of future protection afforded by F-stars intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect F-stars business, or permit F-star to maintain F-stars competitive advantage. The following examples are illustrative:
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others may be able to make bispecific antibodies that are the same as or similar to F-stars mAb2 product candidates but that are not covered by the claims of the patents that F-star own or have exclusively licensed; |
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the patents of third parties may have an adverse effect on F-stars business; |
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F-star or any current or future licensors or strategic partners might not have been the first to conceive or reduce to practice the inventions covered by the issued patent or pending patent application that F-star own or have exclusively licensed; |
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F-star or any future licensors or strategic partners might not have been the first to file patent applications covering certain of F-stars inventions; |
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others may independently develop similar or alternative technologies or duplicate any of F-stars technologies without infringing F-stars intellectual property rights; |
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it is possible that F-stars pending patent applications will not lead to issued patents; |
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issued patents that F-star own or have exclusively licensed may not provide F-star with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by F-stars competitors; |
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F-stars competitors might conduct research and development activities in countries where F-star does not have patent rights and then use the information learned from such activities to develop competitive products for sale in F-stars major commercial markets; |
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third parties performing manufacturing or testing for F-star using F-stars products or technologies could use the intellectual property of others without obtaining a proper license; and |
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F-star may not develop additional technologies that are patentable. |
Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing F-stars ability to protect F-stars products.
As is the case with other biopharmaceutical companies, F-stars success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological complexity and legal complexity. Therefore, obtaining and enforcing biopharmaceutical patents is costly, time-consuming and inherently uncertain. In addition, the America Invents Act (the AIA), has been enacted in the United States, resulting in significant changes to the U.S. patent system.
An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a first-to-file system for deciding which party should be granted a patent when two or more patent applications
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are filed by different parties claiming the same invention. A third party that files a patent application in the USPTO after that date but before F-star could therefore be awarded a patent covering an invention of F-stars even if F-star had made the invention before it was made by the third party. This requires F-star to be cognizant of the time from invention to filing of a patent application, but circumstances could prevent F-star from promptly filing patent applications on F-stars inventions.
Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent in the USPTO via various proceedings including, e.g., post-grant review, inter partes review, and derivation proceedings. This applies to all of F-stars U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate F-stars patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of F-stars patent applications and the enforcement or defense of F-stars issued patents.
Additionally, the U.S. Supreme Court and the Court of Appeals for the Federal Circuit have ruled on patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to F-stars ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken F-stars ability to obtain new patents or to enforce F-stars existing patents and patents that F-star might obtain in the future.
Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and protect other proprietary information.
F-star considers proprietary trade secrets, confidential know-how and unpatented know-how to be important to F-stars business. F-star may rely on trade secrets or confidential know-how to protect F-stars technology, especially where patent protection is believed to be of limited value. However, trade secrets and confidential know-how are difficult to maintain as confidential.
To protect this type of information against disclosure or appropriation by competitors, F-stars policy is to require F-stars employees, consultants, contractors and advisors to enter into confidentiality agreements and invention assignment agreements with F-star. However, F-star cannot be certain that such agreements have been entered into with all relevant parties, and F-star cannot be certain that F-stars trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to F-stars trade secrets or independently develop substantially equivalent information and techniques. Current or former employees, consultants, contractors and advisers may unintentionally or willfully disclose F-stars confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Enforcing a claim that a third party obtained illegally and is using trade secrets or confidential know-how is expensive, time consuming and unpredictable. The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction. Furthermore, if a competitor lawfully obtained or independently developed any of F-stars trade secrets, F-star would have no right to prevent such competitor from using that technology or information to compete with F-star, which could harm F-stars competitive position. Additionally, if the steps taken to maintain F-stars trade secrets are deemed inadequate, F-star may have insufficient recourse against third parties for misappropriating the trade secret.
Failure to obtain or maintain trade secrets or confidential know-how trade protection could adversely affect F-stars competitive position. Moreover, F-stars competitors may independently develop substantially equivalent proprietary information and may even apply for patent protection in respect of the same. If successful in
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obtaining such patent protection, F-stars competitors could limit F-stars use of F-stars trade secrets or confidential know-how.
Under certain circumstances, F-star may also decide to publish some know-how to attempt to prevent others from obtaining patent rights covering such know-how.
F-star may be subject to claims by third parties asserting that F-stars employees or F-star has misappropriated their intellectual property, or claiming ownership of what F-star regard as F-stars own intellectual property.
Many of F-stars employees, including F-stars senior management, were previously employed at other biotechnology or pharmaceutical companies, including F-stars competitors or potential competitors. Some of these employees executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. Although F-star tries to ensure that F-stars employees do not use the proprietary information or know-how of others in their work for F-star, F-star may be subject to claims that F-star or these employees have used or disclosed confidential information or intellectual property, including trade secrets or other proprietary information, of any such employees former employer. Litigation may be necessary to defend against these claims.
If F-star fails in prosecuting or defending any such claims, in addition to paying monetary damages, F-star may lose valuable intellectual property rights or personnel or sustain damages. Such intellectual property rights could be awarded to a third party, and F-star could be required to obtain a license from such third party to commercialize F-stars technology or products. Such a license may not be available on commercially reasonable terms or at all. Even if F-star successfully prosecute or defend against such claims, litigation could result in substantial costs and distract management.
Obtaining and maintaining F-stars patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and F-stars patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance and annuity fees on any issued patent are due to be paid to the USPTO, the EPO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO, the EPO and various foreign governmental patent agencies require compliance with a number of procedural, documentaries, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If F-star or F-stars licensors or collaboration partners fail to maintain the patents and patent applications covering F-stars mAb2 product candidates, F-stars competitors might be able to enter the market, which would have an adverse effect on F-stars business.
Risks Related to F-stars Dependence on Third Parties
F-star relies, and expects to continue to rely, on third parties, including independent clinical investigators, contracted laboratories and CROs, to conduct F-stars preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, F-star may not be able to obtain regulatory approval for or commercialize its mAb2 product candidates and F-stars business could be substantially harmed.
F-star has relied upon and plan to continue to rely upon third parties, including independent clinical investigators, contracted laboratories and third-party CROs, to conduct F-stars preclinical studies and clinical trials in accordance with applicable regulatory requirements and to monitor and manage data for F-stars ongoing preclinical and clinical programs. F-star relies on these parties for execution of its preclinical studies and clinical trials, and controls only certain aspects of their activities. Nevertheless, F-star is responsible for ensuring that
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each of F-stars studies and trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and F-stars reliance on these third parties does not relieve it of its regulatory responsibilities. F-star and its third-party contractors and CROs are required to comply with good laboratory practices (GLPs), as applicable, and GCP requirements, which are regulations and guidelines enforced by the FDA, the EMA and other comparable foreign regulatory authorities for all of F-stars products in clinical development. Regulatory authorities enforce these GLPs and GCPs through periodic inspections of laboratories conducting GLP studies, trial sponsors, principal investigators and trial sites. If F-star, F-stars investigators or any of F-stars CROs or contracted laboratories fail to comply with applicable GLPs and GCPs, the clinical data generated in F-stars clinical trials may be deemed unreliable and the FDA, the EMA or other comparable foreign regulatory authorities may require F-star to perform additional preclinical studies or clinical trials before approving F-stars marketing applications. F-star cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of F-stars preclinical studies or clinical trials comply with applicable GLP or GCP regulations. In addition, F-stars clinical trials must be conducted with product produced in compliance with applicable cGMP regulations. F-stars failure to comply with these regulations may require it to repeat preclinical studies or clinical trials, which would delay the regulatory approval process.
Further, these laboratories, investigators and CROs are not F-stars employees and F-star will not be able to control, other than by contract, the amount of resources, including time, which they devote to F-stars mAb2 product candidates and clinical trials. If independent laboratories, investigators or CROs fail to devote sufficient resources to the development of F-stars mAb2 product candidates, or if their performance is substandard, it may delay or compromise the prospects for approval and commercialization of any mAb2 product candidates that F-star develops. In addition, the use of third-party service providers requires it to disclose F-stars proprietary information to these parties, which could increase the risk that this information will be misappropriated.
F-stars CROs have the right to terminate their agreements with F-star in the event of an uncured material breach. In addition, some of F-stars CROs have an ability to terminate their respective agreements with F-star if it can be reasonably demonstrated that the safety of the subjects participating in F-stars clinical trials warrants such termination, if F-star makes a general assignment for the benefit of F-stars creditors or if F-star is liquidated.
There is a limited number of third-party service providers that specialize or have the expertise required to achieve F-stars business objectives. If any of F-stars relationships with these third-party laboratories, CROs or clinical investigators terminate, F-star may not be able to enter into arrangements with alternative laboratories, CROs or investigators or to do so in a timely manner or on commercially reasonable terms. If laboratories, CROs or clinical investigators do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to F-stars preclinical or clinical protocols, regulatory requirements or for other reasons, F-stars preclinical studies or clinical trials may be extended, delayed or terminated and F-star may not be able to obtain regulatory approval for or successfully commercialize F-stars mAb2 product candidates. As a result, F-stars results of operations and the commercial prospects for F-stars mAb2 product candidates would be harmed, F-stars costs could increase and F-stars ability to generate revenues could be delayed.
Switching or adding additional laboratories or CROs (or investigators) involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new laboratory or CRO commences work. As a result, delays occur, which can materially impact F-stars ability to meet its desired clinical development timelines. Though F-star carefully manages F-stars relationships with its contracted laboratories and CROs, there can be no assurance that F-star will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on F-stars business, financial condition and results of operations.
In addition, clinical investigators may serve as scientific advisors or consultants to F-star from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial
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relationship may have affected the interpretation of the preclinical study or clinical trial, the integrity of the data generated at the applicable preclinical study or clinical trial site may be questioned and the utility of the preclinical study or clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA. Any such delay or rejection could prevent F-star from commercializing its clinical-stage mAb2 product candidate or any future mAb2 product candidates.
The manufacture of biotechnology products is complex, and manufacturers often encounter difficulties in production. If F-star or any of its third party manufacturers encounter such difficulties, or otherwise fail to comply with their contractual obligations, the development or commercialization of F-star mAb2 product candidates could be delayed or stopped.
The manufacture of biotechnology products is generally complex and requires significant expertise and capital investment. F-star and its contract manufacturers must comply with cGMP regulations and guidelines for clinical trial product manufacture and for commercial product manufacture. Manufacturers of biotechnology products often encounter difficulties in production, particularly in scaling up, addressing product quality, product comparability, validating production processes and mitigating potential sources of contamination. These problems include difficulties with raw material procurement, production costs and yields, quality control, product quality, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if microbial, viral or other contaminations are discovered in therapeutic products or in the manufacturing facilities in which F-star product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
F-star cannot assure you that manufacturing problems, including supply chain disruptions of any of mAb2 product candidates or products will not occur in the future. Any delay or interruption in the supply of preclinical or clinical trial supplies, including any delays arising from circumstances related to the COVID-19 pandemic, could delay the completion of these trials, increase the costs associated with maintaining these trial programs and, depending upon the period of delay, require F-star to commence new trials at additional expense or terminate trials completely.
F-star relies on third parties to supply and manufacture F-stars mAb2 product candidates, and F-star expects to continue to rely on third parties to manufacture F-stars products, if approved. The development of such mAb2 product candidates and the commercialization of any products, if approved, could be stopped, delayed or made less profitable if any such third party fails to provide F-star with sufficient quantities of mAb2 product candidates or products or fails to do so at acceptable quality levels or prices or fails to maintain or achieve satisfactory regulatory compliance.
F-star does not currently have the infrastructure or capability internally to manufacture F-stars mAb2 product candidates for use in the conduct of F-stars preclinical studies and clinical trials or for commercial supply, if F-stars products are approved. F-star relies on, and expects to continue to rely on, contract manufacturing organizations (CMOs). F-star currently relies mainly on a few CMOs for the manufacturing of F-stars mAb2 product candidates. Any replacement of F-stars CMOs could require significant effort and expertise because there may be a limited number of qualified CMOs. Reliance on third-party providers may expose F-star to more risk than if F-star were to manufacture F-stars mAb2 product candidates itself. F-star is dependent on its CMOs for the production of F-stars mAb2 product candidates in accordance with relevant regulations, such as cGMP, which includes, among other things, quality control, quality assurance and the maintenance of records and documentation. Moreover, many of the third parties with whom F-star contracts may also have relationships with other commercial entities, including F-stars competitors, for whom they may also be conducting product development activities that could harm F-stars competitive position.
If F-star were to experience an unexpected loss of supply of or if any supplier were unable to meet F-stars demand for any of F-stars mAb2 product candidates, F-star could experience delays in F-stars research or planned clinical trials or future commercialization activities. F-star could be unable to find alternative suppliers of acceptable quality, in the appropriate volumes and at an acceptable cost. Moreover, F-stars suppliers are often
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subject to strict manufacturing requirements and rigorous testing requirements, which could limit or delay production. The long transition periods needed to switch manufacturers and suppliers, if necessary, could significantly delay F-stars clinical studies and the commercialization of F-stars products, if approved, which could materially adversely affect F-stars business, financial condition and results of operation.
In complying with the applicable manufacturing regulations of the FDA, the EMA and other comparable foreign regulatory authorities, F-star and its third-party suppliers must spend significant time, money and effort in the areas of design and development, testing, production, record-keeping and quality control to assure that the products meet applicable specifications and other regulatory requirements. The failure to comply with these requirements could result in an enforcement action against F-star, including the seizure of products and shutting down of production. F-star and any of these third-party suppliers may also be subject to audits by the FDA, the EMA or other comparable foreign regulatory authorities. If any of F-stars third-party suppliers fails to comply with cGMP or other applicable manufacturing regulations, F-stars ability to develop and commercialize its future therapeutics products could suffer significant interruptions. F-star face risks inherent in relying on a single CMO, as any disruption, such as a fire, natural hazards or vandalism at the CMO could significantly interrupt F-stars manufacturing capability. All of F-stars CMOs currently do not have alternative production plans in place or disaster-recovery facilities available. In case of a disruption, F-star will have to establish alternative manufacturing sources. This would require substantial capital on F-stars part, which F-star may not be able to obtain on commercially acceptable terms or at all. Additionally, F-star would likely experience months of manufacturing delays as the CMO builds or locates replacement facilities and seeks and obtains necessary regulatory approvals. If this occurs, F-star will be unable to satisfy manufacturing needs on a timely basis, if at all.
The manufacturing of all of F-stars mAb2 product candidates requires using cells that are stored in a cell bank. F-star has one master cell bank for each product manufactured in accordance with cGMP. Working cell banks have not yet been manufactured. Half of each master cell bank is stored at a separate site so that in case of a catastrophic event at one site F-star believes sufficient vials of the master cell banks are left at the alternative storage site to continue manufacturing. F-star believes sufficient working cell banks could be produced from the vials of the master cell bank stored at a given site to assure product supply for the future. However, it is possible that F-star could lose multiple cell banks and have F-stars manufacturing significantly impacted by the need to replace these cell banks, which could materially adversely affect F-stars business, financial condition and results of operations.
F-stars employees and independent contractors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
F-star is exposed to the risk of fraud or other misconduct by its employees or independent contractors. Misconduct by these parties could include intentional failures to comply with applicable laws or regulations, provide accurate information to the FDA, EMA or foreign regulatory authorities, comply with manufacturing standards establishes for F-stars product candidates, comply with federal and state data privacy, security, fraud and abuse, and other healthcare laws and regulations, report financial information or data accurately or disclose unauthorized activities to F-star. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, which could result in regulatory sanctions and cause serious harm to F-stars reputation.
It is not always possible to identify and deter misconduct by employees and third parties, and the precautions F-star takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting it from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Additionally, F-star is subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such
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actions are instituted against F-star, and it is not successful in defending itself or asserting its rights, those actions could have a material and adverse effect on F-stars business, financial condition, results of operations and prospects, including the imposition of significant civil, criminal and administrative penalties, monetary damages, fines, disgorgement, imprisonment, loss of eligibility to obtain marketing approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, reputational harm, diminished profits and future earnings, additional reporting requirements if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with any of these laws, and the curtailment or restructuring of its operations.
F-star relies and expects to continue to rely on collaborative partners regarding the development of certain of F-stars research programs and mAb2 product candidates. If F-star is not able to maintain its current relationships or enter into new strategic relationships, F-stars business, financial condition, commercialization prospects and results of operations may be adversely affected.
F-star is, and expects to continue to be, dependent on partnerships with partners relating to the development and commercialization of certain of F-stars existing and future research programs and mAb2 product candidates. F-star currently has collaborative research relationships with each of Ares Trading S.A. (Ares), an affiliate of Merck KGaA, Darmstadt, Germany, Denali Therapeutics Inc. and Kymab Limited for the development of certain mAb2 product candidates resulting from such collaborations. F-star has, and may in the future, depending on F-stars business strategy, continue to have discussions on potential partnering opportunities with various pharmaceutical companies. If F-star fails to enter into or maintain collaborations on reasonable terms or at all, F-stars ability to develop F-stars existing or future research programs and mAb2 product candidates could be delayed, the commercial potential of F-stars product could change and F-stars costs of development and commercialization could increase. Furthermore, F-star may find that F-stars programs require the use of intellectual property rights held by third parties, and the growth of F-stars business may depend in part on F-stars ability to acquire or in-license these intellectual property rights.
F-stars dependence on collaborative partners subjects it to a number of risks, including, but not limited to, the following:
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F-star may not be able to control the amount and timing of resources that the collaboration partner devotes to F-stars research programs and mAb2 product candidates; |
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for collaboration agreements where F-star is solely or partially responsible for funding development expenses through a defined milestone event, the payments F-star receive from the collaboration partner may not be sufficient to cover the expenses F-star has or would need to incur in order to achieve that milestone event; |
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F-star may be required to relinquish significant rights to F-stars collaborative partners, including rights to exploit F-stars intellectual property and marketing and distribution rights; |
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if the development of the relevant mAb2 product candidates is not successful, F-stars anticipated payments under any partnership agreement (e.g., royalty payments for licensed products) may not materialize; |
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F-star relies on the information and data received from third parties regarding their research programs and mAb2 product candidates and will not have control of the process conducted by the third party in gathering and composing such data and information; |
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if rights to develop and commercialize F-stars mAb2 product candidates that are subject to collaborations revert to it for any reason, F-star may not have sufficient financial resources to develop such mAb2 product candidates, which may result in F-star failing to recognize any value from F-stars investments in developing such mAb2 product candidates; |
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a collaborative partner may develop a competing product either by itself or in collaboration with others, including one or more of F-stars competitors, or seek to restrict F-star from working with other collaborators that may compete with F-stars partners products, which could deprioritize the development of F-stars products; |
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F-stars collaborative partners willingness or ability to complete their obligations under F-stars partnership arrangements may be adversely affected by business combinations or significant changes in a collaborative partners business strategy; |
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F-star may experience delays in, or increases in the costs of, the development of F-stars research programs and mAb2 product candidates due to the termination or expiration of collaborative research and development arrangements; |
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F-star may have disagreements with collaborative partners, including disagreements over proprietary rights, contract interpretation, non-competition limitations, or the preferred course of development, that might cause delays or termination of the research, development or commercialization of mAb2 product candidates, might lead to additional responsibilities for F-star with respect to mAb2 product candidates, or might result in litigation or arbitration, any of which may be time-consuming and expensive; |
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collaborative partners may not properly maintain or defend F-stars intellectual property rights or may use proprietary information in such a way as to invite litigation or other intellectual property-related proceedings that could invalidate F-stars intellectual property or jeopardize F-stars proprietary information or expose F-star to potential litigation; or |
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collaborative partners may infringe or otherwise violate the intellectual property rights of third parties, which may expose F-star to litigation and potential liability. |
F-star faces significant competition in seeking appropriate collaborative partners. F-stars ability to reach a definitive agreement for a partnership will depend, among other things, upon an assessment of the collaborators resources and expertise, the terms and conditions of the proposed partnership and the proposed collaborators evaluation of a number of factors. These factors may include the design or results of preclinical studies or clinical trials, the likelihood of regulatory approval, the potential market for the subject mAb2 product candidate, the costs and complexities of manufacturing and delivering such mAb2 product candidate to patients, the potential of competing products, the existence of any uncertainty with respect to F-stars ownership of technology (which can exist if there is a challenge to such ownership regardless of the merits of the challenge) and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a partnership could be more attractive than the one with F-star.
F-star may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If F-star is unable to do so, F-star may have to curtail the development of the mAb2 product candidate for which F-star is seeking to collaborate, reduce or delay its development program or one or more of F-stars other development programs, delay its potential commercialization, reduce the scope of any sales or marketing activities or increase F-stars expenditures and undertake development or commercialization activities at F-stars own expense. If F-star elect to increase F-stars expenditures to fund development or commercialization activities on F-stars own, F-star may need to obtain additional capital, which may not be available to F-star on acceptable terms or at all. If F-star does not have sufficient funds, F-star may not be able to further develop mAb2 product candidates or bring them to market and generate product revenue.
Risks Related to F-stars Business Operations, Employee Matters and Managing Growth
F-stars future growth and ability to compete depends on retaining F-stars key personnel and recruiting additional qualified personnel.
F-stars success depends upon the continued contributions of its key management, scientific and technical personnel, many of whom have been instrumental for F-star and have substantial experience with F-stars mAb2 product candidates, mAb2 technology and modular antibody technology platform. F-star is highly dependent upon F-stars senior management, particularly Eliot Forster, F-stars Chief Executive Officer, Neil Brewis, F-stars Chief Scientific Officer, and Louis Kayitalire, F-stars Chief Medical Officer, as well as F-stars senior scientists and other members of F-stars senior management team.
The loss of key managers and senior scientists could delay F-stars research and development activities. In addition, F-stars ability to compete in the highly competitive biotechnology and pharmaceutical industries
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depends upon F-stars ability to attract and retain highly qualified management, scientific and medical personnel. Many other biotechnology and pharmaceutical companies and academic institutions that F-star competes with for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than F-star does. Therefore, F-star might not be able to attract or retain these key persons on conditions that are economically acceptable. Furthermore, F-star will need to recruit new managers and qualified scientific personnel to develop F-stars business if F-star expand into fields that will require additional skills. F-stars inability to attract and retain these key persons could prevent F-star from achieving its objectives and implementing F-stars business strategy, which could have a material adverse effect on F-stars business and prospects.
F-star expects to expand F-stars development, regulatory and sales and marketing capabilities, and as a result, F-star may encounter difficulties in managing F-stars growth, which could disrupt its operations.
F-star expects to experience significant growth in the number of F-stars employees and the scope of F-stars operations, particularly in the areas of drug development, manufacturing, regulatory affairs and sales and marketing. To manage F-stars anticipated future growth, F-star must continue to implement and improve F-stars managerial, operational and financial systems, expand F-stars facilities and continue to recruit and train additional qualified personnel. Due to F-stars limited financial resources and the limited experience of F-stars management team in managing a company with such anticipated growth, F-star may not be able to effectively manage the expansion of F-stars operations or recruit and train additional qualified personnel. The expansion of F-stars operations may lead to significant costs and may divert F-stars management and business development resources. Any inability to manage growth could delay the execution of F-stars business plans or disrupt F-stars operations.
F-stars business is subject to economic, political, regulatory and other risks associated with international operations.
As a company incorporated and based in the United Kingdom, F-stars business is subject to risks associated with conducting business internationally. Accordingly, F-stars future results could be harmed by a variety of factors, including:
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economic weakness, including inflation, or political instability in particular non-U.S. economies and markets; |
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differing regulatory requirements for product approvals; |
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differing jurisdictions could present different issues for securing, maintaining or obtaining freedom to operate in such jurisdictions; |
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potentially reduced protection for intellectual property rights; |
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difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations; |
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changes in non-U.S. regulations and customs, tariffs and trade barriers; |
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changes in non-U.S. currency exchange rates of the pound sterling, U.S. dollar, euro and currency controls; |
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changes in a specific countrys or regions political or economic environment, including the implications of the United Kingdoms withdrawal from the European Union; |
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trade protection measures, import or export licensing requirements or other restrictive actions by governments; |
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differing reimbursement regimes and price controls in certain international markets; |
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negative consequences from changes in tax laws; |
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad, including, for example, the variable tax treatment in different jurisdictions of share options granted under F-stars employee stock plan or equity incentive plan; |
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workforce uncertainty in countries where labor unrest is more common than in the United States; |
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difficulties associated with staffing and managing international operations, including differing labor relations; |
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
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business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires. |
Exchange rate fluctuations may materially affect F-stars results of operations and financial condition.
Due to the international scope of F-stars operations, F-stars assets, earnings and cash flows are affected by fluctuations in the exchange rates of several currencies, particularly the U.S. dollar and pound sterling. The functional currency of F-star Therapeutics Limited and F-stars English subsidiaries is the pound sterling and the majority of F-stars operating expenses are paid in pounds sterling. The functional currency of F-stars Austrian subsidiary is the euro.
Additionally, although F-star is based primarily in the United Kingdom, F-star may receive payments from F-stars business partners in U.S. dollars, Swiss francs and euros and F-star regularly acquire services, consumables and materials in U.S. dollars and euros. Further, potential future revenue may be derived from the United States, countries within the euro zone and various other countries around the world. These future revenues may also be affected by fluctuations in foreign exchange rates which may, in turn, have a significant impact on F-stars results of operations and cash flows from period to period. As a result, to the extent F-star continue F-stars expansion on a global basis, F-star expects that increasing portions of F-stars revenue, cost of revenue, assets and liabilities will be affected by fluctuations in currency valuations. F-star may, therefore, experience economic loss and a negative impact on earnings or net assets solely as a result of currency exchange rate fluctuations.
F-stars business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in F-star, or F-stars collaborators or third-party vendors, cyber-security.
F-star collects, stores and transmits large amounts of confidential information, including personal information, operational and financial transactions and records, clinical trial data and information relating to intellectual property, on internal information systems and through the information systems of collaborators and third-party vendors with whom F-star contracts. Despite the implementation of security measures, these information systems are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the internet or other mechanisms, attachments to emails, persons inside F-stars organization, or persons with access to systems inside the organization. No such security measures can eliminate the possibility of the information systems improper functioning or the improper access or disclosure of confidential or personally identifiable information such as in the event of cyber-attacks. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, criminals, ex-U.S. governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
Additionally, outside parties may attempt to fraudulently induce employees, collaborators, or other third-party vendors to disclose sensitive information or take other actions, including making fraudulent payments or downloading malware, by using spoofing and phishing emails or other types of attacks. F-star has previously experienced, and in the future may experience Phishing attacks despite efforts to prevent and mitigate future instances. For example, in recent years F-star was the target of cyber-attacks comprised of phishing incidents where an immaterial unauthorized payment was made based on misrepresentations or confidential company information was inadvertently shared with an unauthorized external party. The related immaterial payment was recovered by F-star upon identification of the incident. The unauthorized data shared was anonymized therefore no GDPR protection regulations were breached. After an internal investigation, it was determined that no further action was required under either U.K., U.S. federal or state law. It was deemed that the cyber-attacks did not have
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a material impact to F-stars business or financial condition. As a result of these incidents F-star, increased its cybersecurity training for all staff. While F-star believes it responded appropriately, including implementing remedial measures to stop this cyber-attack and with the goal of preventing similar events in the future, there can be no assurance that F-star will be successful in these remedial and preventative measures or successfully mitigating the effects of future cyber-attacks.
If such future events were to occur and cause interruptions in F-stars operations, it could result in a material disruption of F-stars clinical and research and development activities and business operations. To the extent that any disruption or security breach was to result in a loss of or damage to F-stars data or applications, or inappropriate disclosure of confidential or proprietary information or making of fraudulent payments, F-star could incur material legal claims and liability, damage to F-stars reputation, suffer loss or harm to F-stars intellectual property rights, face significant financial exposure, including incurring significant costs to remediate possible injury to the affected parties and the further research, development and commercial efforts of F-stars future mAb2 products and product candidates could be delayed.
F-stars employees, independent contractors, vendors, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
F-star is exposed to the risk that its employees, independent contractors, vendors, principal investigators, CROs and consultants may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to F-star that violate the regulations of the FDA, the EMA and other comparable foreign regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities; healthcare fraud and abuse laws and regulations in the United States and abroad; or laws that require the reporting of financial information or data accurately. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials or creating fraudulent data in F-stars preclinical studies or clinical trials, which could result in regulatory sanctions and cause serious harm to F-stars reputation. F-star intends to adopt, prior to the completion of this offering, a code of conduct applicable to all of F-stars employees, but it is not always possible to identify and deter misconduct by employees and other third parties, and the precautions F-star take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting F-star from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. Additionally, F-star is subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against F-star, and F-star is not successful in defending itself or asserting F-stars rights, those actions could have a significant impact on F-stars business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, additional reporting requirements and oversight if F-star become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of F-stars operations, any of which could adversely affect F-stars ability to operate F-stars business, financial condition and results of operations.
Failure to comply with health and data protection laws and regulations could lead to government enforcement actions, including civil or criminal penalties, private litigation, and adverse publicity and could negatively affect F-stars operating results and business.
F-star and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations, such as laws and regulations that address privacy and data security. In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws,
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including Section 5 of the Federal Trade Commission Act, that govern the collection, use, disclosure and protection of health-related and other personal information could apply to F-stars operations or the operations of F-stars collaborators. In addition, F-star may obtain health information from third parties, including research institutions from which F-star obtains clinical trial data that are subject to privacy and security requirements under HIPAA, as amended by HITECH. Depending on the facts and circumstances, F-star could be subject to civil, criminal, and administrative penalties if F-star knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
Compliance with U.S. and international data protection laws and regulations could require F-star to take on more onerous obligations in F-stars contracts, restrict F-stars ability to collect, use and disclose data, or in some cases, impact F-stars ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect F-stars operating results and business. Moreover, clinical trial subjects, employees and other individuals about whom F-star or F-stars potential collaborators obtain personal information, as well as the providers who share this information with F-star, may limit F-stars ability to collect, use and disclose the information. Claims that F-star has violated individuals privacy rights, failed to comply with data protection laws, or breached F-stars contractual obligations, even if F-star is not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm F-stars business.
F-star is subject to the U.K. Bribery Act 2010, the U.S. Foreign Corrupt Practices Act of 1977, and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing F-stars operations.
F-stars operations are subject to anti-corruption laws, including the U.K. Bribery Act 2010 (the Bribery Act), the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. §201, the U.S. Travel Act and other anti-corruption laws that apply in countries where F-star does business. The Bribery Act, the FCPA and these other laws generally prohibit F-star and F-stars employees and intermediaries from authorizing, promising, offering, or providing, directly or indirectly, a financial or other advantage to government officials or other persons to induce them to improperly perform a relevant function or activity (or reward them for such behavior).
Under the Bribery Act, F-star may also be liable for failing to prevent a person associated with F-star from committing a bribery offense. F-star, along with those acting on F-stars behalf and F-stars commercial partners, operate in a number of jurisdictions that pose a high risk of potential Bribery Act or FCPA violations, and F-star participates in collaborations and relationships with third parties whose corrupt or illegal activities could potentially subject F-star to liability under the Bribery Act, FCPA or local anti-corruption laws, even if F-star does not explicitly authorize or have actual knowledge of such activities. In addition, F-star cannot predict the nature, scope or effect of future regulatory requirements to which F-stars international operations might be subject or the manner in which existing laws might be administered or interpreted.
Compliance with the Bribery Act, the FCPA and these other laws is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, anti-corruption laws present particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials.
F-star is also subject to other laws and regulations governing F-stars international operations, including regulations administered by the governments of the United Kingdom and the United States, and authorities in the European Union, including applicable export control regulations, economic sanctions and embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements and currency exchange regulations, collectively referred to as the Trade Control laws.
There is no assurance that F-star will be completely effective in ensuring F-stars compliance with all applicable anti-corruption laws, including the Bribery Act, the FCPA or other legal requirements, including Trade Control laws. If F-star is not in compliance with the Bribery Act, the FCPA and other anti-corruption laws
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or Trade Control laws, F-star may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses. Such liabilities could have an adverse impact on F-stars business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of the Bribery Act, the FCPA, other anti-corruption laws or Trade Control laws could also have an adverse impact on F-stars reputation, business, results of operations and financial condition. Further, the failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting.
If F-star fails to comply with environmental, health and safety laws and regulations, F-star could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of F-stars business.
F-star is subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. F-stars operations involve the use of hazardous and flammable materials, including chemicals and biological materials. F-stars operations also produce hazardous waste products. F-star generally contract with third parties for the disposal of these materials and wastes. F-star cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from F-stars use of hazardous materials, F-star could be held liable for any resulting damages, and any liability could exceed F-stars resources. F-star also could incur significant costs associated with civil or criminal fines and penalties.
Although F-star maintains workers compensation insurance to cover it for costs and expenses F-star may incur due to injuries to F-stars employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. F-star does not maintain insurance for environmental liability or toxic tort claims that may be asserted against F-star in connection with F-stars storage or disposal of biological, hazardous or radioactive materials.
Legal, political and economic uncertainty surrounding the exit of the United Kingdom from the European Union may be a source of instability in international markets, create significant currency fluctuations, adversely affect F-stars operations in the United Kingdom and pose additional risks to F-stars business, revenue, financial condition, and results of operations.
On June 23, 2016, the electorate in the United Kingdom voted in favor of Brexit. Thereafter, on March 29, 2017, the country formally notified the EU of its intention to withdraw pursuant to Article 50 of the Lisbon Treaty. The withdrawal of the United Kingdom from the European Union took effect on January 31, 2020 the effective date of the withdrawal agreement with a transition period due to end on December 31, 2020. It appears likely that this withdrawal will involve a process of lengthy negotiations between the United Kingdom and European Union member states to determine the future terms of the United Kingdoms relationship with the European Union. This could lead to a period of considerable uncertainty and volatility, particularly in relation to United Kingdom financial and banking markets. Weakening of economic conditions or economic uncertainties could harm F-stars business, and if such conditions emerge in the United Kingdom or in the rest of Europe, it may have a material adverse effect on F-stars operations.
Currency exchange rates in the pound sterling and the euro with respect to each other and the U.S. dollar have already been adversely affected by Brexit and that may continue to be the case. In addition, depending on the terms of Brexit, the United Kingdom could lose the benefits of global trade agreements negotiated by the European Union on behalf of its members, which may result in increased trade barriers which could make doing business in Europe more difficult.
F-star may also face new and additional regulatory costs and challenges from Brexit that could have a material adverse effect on operations. Since a significant proportion of the regulatory framework in the United Kingdom is derived from EU directives and regulations, the referendum could materially impact the regulatory regime with respect to the approval of F-stars product candidates in the United Kingdom or the European Union. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, would prevent F-star from commercializing product candidates in the United Kingdom and/or the EU and restrict
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its ability to generate revenue and achieve and sustain profitability. If any of these outcomes occur, F-star may be forced to restrict or delay efforts to seek regulatory approval in the United Kingdom and/or EU for its product candidates, which could significantly and materially harm F-stars business.
European data collection (in the context of a European establishment or related to the monitoring of European individuals behavior) is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
The collection and use of personal health data in the European Union is governed by the provisions of the GDPR. This legislation imposes requirements relating to having legal bases for processing personal information relating to identifiable individuals (personal data) and transferring such information outside the European Economic Area (EEA) including to the United States, providing details to those individuals regarding the processing of their personal data, keeping personal data secure, having data processing agreements with third parties who process personal data on F-stars behalf, responding to individuals requests to exercise their rights in respect of their personal data, reporting security breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments and record-keeping. As F-star has operations based in the United Kingdom and Austria, F-star is subject to the GDPR because of F-stars data processing activities that involve the personal data of individuals in connection with F-stars clinical trials. The GDPR imposes responsibilities and liabilities in relation to personal data that F-star process and F-star may be required to put in place additional mechanisms ensuring compliance with these data protection rules. This may be onerous and may interrupt or delay F-stars development activities, and adversely affect F-stars business, financial condition, results of operations and prospects. Failure to comply with the requirements of the GDPR and related national data protection laws of the member states of the European Union may result in substantial fines, other administrative penalties and civil claims being brought against F-star, which could have a material adverse effect on F-stars business, results of operations and financial condition.
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This proxy statement/prospectus and the documents incorporated by reference into this proxy statement/prospectus contain forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended (as amended, the Exchange Act), and Section 27A of the United States Securities Act of 1933, as amended (as amended, the Securities Act) concerning Spring Bank, F-star, the proposed Exchange and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Spring Bank and F-star, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as may, will, should, would, expect, plan, believe, intend, look forward, and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance.
For example, forward-looking statements include, but are not limited to statements about:
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the strategies, prospects, plans, expectations and objectives of management of the combined company for future operations of the combined company following the closing of the Exchange; |
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the level of net cash held by Spring Bank at the closing of the Exchange; |
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F-stars ability to complete the Pre-Closing Financing and the proceeds expected to be received therefrom; |
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the approval and closing of the Exchange, including the timing of the Exchange, the ability of Spring Bank to obtain stockholder approval for the Exchange, other conditions to the completion of the Exchange, the adjustment of the Exchange Ratio, and relative ownership levels as of the closing of the Exchange; |
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the progress, scope or duration of the development of product candidates or programs; |
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statements concerning proposed clinical trials or product candidates; |
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the benefits that may be derived from, or the commercial or market opportunity of, product candidates; |
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the ability of Spring Bank or F-star to protect their intellectual property rights; |
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the anticipated operations, financial position, losses, costs or expenses of Spring Bank, F-star or the combined company following the closing of the Exchange; |
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statements regarding future economic conditions or performance; |
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the expected benefits of and potential value created by the Exchange for the stockholders of Spring Bank; and |
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statements of belief and any statement of assumptions underlying any of the foregoing. |
Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Neither Spring Bank nor F-star can give assurance that the conditions to the Exchange will be satisfied. Except as required by applicable law, Spring Bank undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
For a discussion of the factors that may cause Spring Bank, F-star or the combined companys actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, or for a discussion of risks associated with the ability of Spring Bank and F-star to complete the Exchange and the effect of the Exchange on the business of Spring Bank, F-star and the combined company, see the section titled Risk Factors in this proxy statement/prospectus.
Additional factors that could cause actual results to differ materially from those expressed in the forward-looking statements are discussed in reports filed with the SEC by Spring Bank. See the section titled Where You
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Can Find More Information in this proxy statement/prospectus. There can be no assurance that the Exchange will be completed, or if it is completed, that it will be completed within the anticipated time period or that the expected benefits of the Exchange will be realized.
If any of these risks or uncertainties materialize or any of these assumptions prove incorrect, the results of operations of Spring Bank, F-star or the combined company could differ materially from the forward-looking statements. All forward-looking statements in this proxy statement/prospectus are current only as of the date on which the statements were made. Spring Bank and F-star do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any statement is made, the occurrence of unanticipated events or any new information that becomes available in the future.
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THE SPECIAL MEETING OF SPRING BANK STOCKHOLDERS
Date, Time and Place
The Special Meeting will be held virtually via live audio webcast on the internet on , 2020, at www.virtualshareholdermeeting.com/SBPH2020SM commencing at Eastern time. Spring Bank is delivering this proxy statement/prospectus to its stockholders in connection with the solicitation of proxies by the Spring Bank Board of Directors (the Spring Bank Board) for use at the Special Meeting and any postponements or adjournments of the Special Meeting. This proxy statement/prospectus is first being furnished to Spring Bank stockholders on or about , 2020.
Purposes of the Special Meeting
The purposes of the Special Meeting are:
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To approve the issuance of Spring Bank common stock to the holders of F-star share capital in the Exchange, including holders who purchase ordinary shares of F-star in the Pre-Closing Financing, in accordance with the Exchange Agreement, a copy of which is attached to this proxy statement/prospectus as Annex A, in an amount representing more than 20% of the shares of Spring Bank common stock outstanding immediately prior to the Exchange, which will also constitute stockholder approval of a change of control of Spring Bank, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively; |
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To approve an amendment to Spring Banks amended and restated certificate of incorporation to effect the Reverse Stock Split, in the form attached to this proxy statement/prospectus as Annex C; |
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To approve an amendment to Spring Banks amended and restated certificate of incorporation to effect the Spring Bank Name Change effective as of the Closing, in the form attached to this proxy statement/prospectus as Annex D; |
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To approve a postponement or adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 or 3; and |
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To transact such other business as may properly come before the Special Meeting or any postponement or adjournment thereof. |
Recommendation of the Spring Bank Board
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The Spring Bank Board has determined that the transactions contemplated by the Exchange Agreement are fair to, advisable and in the best interests of Spring Bank and Spring Bank stockholders and has approved and declared advisable the Exchange Agreement and such transactions, including the issuance of shares of Spring Bank common stock to the holders of F-star share capital pursuant to the terms of the Exchange Agreement. The Spring Bank Board unanimously recommends that Spring Bank stockholders vote FOR Proposal No. 1 to approve the issuance of Spring Bank common stock to the holders of F-star share capital pursuant to the Exchange Agreement, including holders of F-star share capital who purchase F-star securities in the Pre-Closing Financing. |
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The Spring Bank Board has determined that the Reverse Stock Split is fair to, advisable and in the best interests of Spring Bank and Spring Bank stockholders and has approved and declared advisable the Reverse Stock Split. The Spring Bank Board unanimously recommends that Spring Bank stockholders vote FOR Proposal No. 2 to approve an amendment to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split. |
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The Spring Bank Board has determined that the Spring Bank Name Change is fair to, advisable and in the best interests of Spring Bank and Spring Bank stockholders and has approved and declared advisable the Spring Bank Name Change. The Spring Bank Board unanimously recommends that Spring Bank stockholders vote FOR Proposal No. 3 to approve an amendment to the amended and restated certificate of incorporation of Spring Bank to effect the Spring Bank Name Change. |
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The Spring Bank Board has determined and believes that postponing or adjourning the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal |
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Nos. 1, 2 or 3 is advisable to, and in the best interests of, Spring Bank and Spring Bank stockholders. The Spring Bank Board unanimously recommends that Spring Bank stockholders vote FOR Proposal No. 4 to postpone or adjourn the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 or 3. |
Record Date and Voting Power
Only holders of record of Spring Bank common stock at the close of business on the Record Date , 2020, are entitled to notice of, and to vote at, the Special Meeting. There were approximately holders of record of Spring Bank common stock at the close of business on the Record Date. At the close of business on the Record Date, shares of Spring Bank common stock were issued and outstanding. Each share of Spring Bank common stock entitles the holder thereof to one vote on each matter submitted for stockholder approval at the Special Meeting.
Voting and Revocation of Proxies
The proxy accompanying this proxy statement/prospectus is solicited on behalf of the Spring Bank Board for use at the Special Meeting.
Whether you plan to attend the Special Meeting or not, Spring Bank urges you to vote by proxy. All shares represented by valid proxies that Spring Bank receives through this solicitation, and that are not revoked, will be voted in accordance with your instructions on the proxy card or as instructed via internet or telephone. You may specify whether your shares should be voted for, against or abstain with respect to each of the proposals. Voting by proxy will not affect your right to attend the Special Meeting. Whether your shares are registered directly in your name through Spring Banks stock transfer agent, Computershare Trust Company, N.A. or your shares are held by a brokerage firm, bank, dealer or other similar organization (i.e., in street name), you may vote:
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By internet (www.proxyvote.com). Use the internet to transmit your voting instructions. Have your proxy card and your 16-digit control number(s) in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form. On this website, you can also elect to receive future distributions of Spring Banks proxy statements and annual reports to stockholders by electronic delivery. |
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By telephone (1-800-690-6903). Use a touch-tone phone to transmit your voting instructions. Have your proxy card and 16-digit control number(s) in hand when you call and then follow the instructions. |
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By mail. If you received a proxy card by mail, you can vote by mail by completing, signing, dating and returning the proxy card as instructed on the card. Return the proxy card in the postage-paid envelope Spring Bank has provided or return it to Voting Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717. |
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At the Special Meeting (www.virtualshareholdermeeting.com/SBPH2020SM). The meeting will be held entirely online. To participate in the meeting, you will need the 16-digit control number included in your proxy materials or the accompanying instructions. The meeting webcast will begin promptly at Eastern time. Spring Bank encourages you to access the meeting prior to the start time. Online check-in will begin at Eastern time, and you should allow ample time to test your computer and for the check-in procedures. |
If your shares of Spring Bank common stock are held in an account at a brokerage firm, bank, dealer or other similar organization, that is, in street name, you should receive voting instructions from the organization that holds your shares. If you do not give instructions to such organization, as your nominee, such nominee can vote your shares of Spring Bank common stock with respect to discretionary items but not with respect to non-discretionary items. Discretionary items are proposals considered routine under the rules of Nasdaq for which your broker or other agent may vote shares held in street name in the absence of your voting instructions. On non-discretionary items for which you do not give your broker or other agent instructions, the shares of Spring Bank common stock will be treated as broker non-votes. It is anticipated that all proposals will be discretionary items other than Proposal No. 1.
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All properly executed proxies that are not revoked will be voted at the Special Meeting and at any postponements or adjournments of the Special Meeting in accordance with the instructions contained in the proxy. If a holder of shares of Spring Bank common stock executes and returns a proxy and does not specify otherwise, the shares of Spring Bank common stock represented by that proxy will be voted FOR all of the proposals in accordance with the recommendation of the Spring Bank Board.
Spring Bank stockholders of record, other than those Spring Bank stockholders who have executed Voting Agreements, may change their vote at any time before their proxy is voted at the Special Meeting in one of three ways:
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send timely written notice to Spring Banks Corporate Secretary stating that the stockholder would like to revoke its proxy; |
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submit new proxy instructions either on a new proxy card or via phone or the internet; or |
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attend the Special Meeting and vote. Simply attending the Special Meeting will not, by itself, revoke your proxy. |
If a Spring Bank stockholder who owns shares of Spring Bank common stock in street name has instructed a broker to vote its shares of Spring Bank common stock, the stockholder must follow the directions received from its broker to change those instructions.
Required Vote
The presence, at the Special Meeting of the holders of a majority in voting power of the shares of Spring Bank common stock outstanding on the Record Date and entitled to vote at the Special Meeting is necessary to constitute a quorum at the Special Meeting. Abstentions and broker non-votes will be counted toward a quorum. The affirmative vote of a majority of the voting power of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter, assuming a quorum is present, is required for approval of Proposal Nos. 1, and 4. The affirmative vote of the holders of a majority of shares of Spring Bank common stock having voting power outstanding on the Record Date is required for approval of Proposals Nos. 2 and 3.
The approval of Proposal No. 1 is a condition to the completion of the Exchange. Therefore, the Exchange cannot be consummated without the approval of Proposal No. 1. Further, the approval of the Reverse Stock Split (Proposal No. 2) is required in order to allow the combined company to meet the initial listing requirements of the Nasdaq Capital Market. Consequently, if the requisite Spring Bank stockholders approve the Exchange and the issuance of Spring Bank common stock pursuant to the Exchange Agreement but do not approve the Reverse Stock Split, the Exchange will not be consummated. However, Proposal No. 2 is not conditioned upon the consummation of the Exchange, and as such, the Reverse Stock Split may be implemented by the Spring Bank Board even if the Exchange does not take place. Proposal No. 3 is conditioned upon the consummation of the Exchange. If the Exchange is not completed, Proposal No. 3 will not be implemented, and Spring Banks name will not be changed.
Votes will be counted by the inspector of election appointed for the Special Meeting, who will separately count FOR and AGAINST votes, abstentions and broker non-votes. Abstentions and broker non-votes will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Special Meeting. Abstentions and broker non-votes will not, however, be considered votes cast at the Special Meeting and voting affirmatively or negatively. Broker non-votes will not have any effect with respect to Proposal No. 1. Abstentions will have the same effect as AGAINST votes for Proposal Nos. 2 and 3. Abstentions will not have any effect with respect to Proposal No. 4.
As of September 15, 2020, the directors and executive officers of Spring Bank owned approximately 7.7% of the outstanding shares of Spring Bank common stock entitled to vote at the Special Meeting. All of the directors and executive officers of Spring Bank are subject to Voting Agreements. Each Spring Bank stockholder that entered into a Voting Agreement has agreed to vote all shares of Spring Bank common stock owned by such holder as of the Record Date in favor of approval of (i) the issuance of Spring Bank common stock to the holders of F-star share capital pursuant to the Exchange, which will represent more than 20% of the shares of Spring Bank common stock outstanding immediately prior to the Exchange, and the change of control resulting
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from the Exchange, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively, (ii) an amendment to the amended and restated certificate of incorporation of Spring Bank to effect the Reverse Stock Split, (iii) an amendment to the amended and restated certificate of incorporation of Spring Bank to effect the Spring Bank Name Change, (iv) any proposal to postpone or adjourn the meeting to a later date, if there are not sufficient votes for the approval of the Exchange and other matters to be approved on the date of the Special Meeting, and (v) any other proposal included in this proxy statement/prospectus in connection with, or related to, the consummation of the Exchange for which the Board of Directors of Spring Bank has unanimously recommended that the stockholders of Spring Bank vote in favor. As of , 2020, Spring Bank is not aware of any affiliate of F-star owning any shares of Spring Bank common stock entitled to vote at the Special Meeting.
Solicitation of Proxies
In addition to solicitation by mail, the directors, officers, employees and agents of Spring Bank may solicit proxies from Spring Bank stockholders by personal interview, telephone, telegram or otherwise. Spring Bank and F-star will share equally the costs of printing and filing this proxy statement/prospectus and proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Spring Bank common stock for the forwarding of solicitation materials to the beneficial owners of Spring Bank common stock. Spring Bank will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials. Spring Bank has engaged The Proxy Advisory Group, LLC to assist in the solicitation of proxies and provide related advice and informational support, for a services fee and the reimbursement of customary disbursements, which are not expected to exceed $25,000 in total.
Other Matters
As of the date of this proxy statement/prospectus, the Spring Bank Board does not know of any business to be presented at the Special Meeting other than as set forth in the notice accompanying this proxy statement/prospectus. If any other matters should properly come before the Special Meeting, it is intended that the shares represented by proxies will be voted with respect to such matters in accordance with the judgment of the persons voting the proxies.
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This section and the section titled The Exchange Agreement in this proxy statement/prospectus describe the material aspects of the Exchange, including the Exchange Agreement. While Spring Bank and F-star believe that this description covers the material terms of the Exchange and the Exchange Agreement, it may not contain all of the information that is important to you. You should carefully read this entire proxy statement/prospectus for a more complete understanding of the Exchange and the Exchange Agreement, including the Exchange Agreement attached as Annex A, the fairness opinion of Ladenburg attached as Annex B, and the other documents to which you are referred herein. See the section titled Where You Can Find More Information in this proxy statement/prospectus.
Background of the Exchange
The terms of the Exchange Agreement are the result of extensive arms-length negotiations among members of the Spring Bank Special Committee (as defined below), Spring Banks management team, the management team of F-star, F-stars Special Committee of the Board of Directors of F-star, along with their respective advisors and under the guidance of each companys board of directors. Spring Bank followed a careful process, assisted by experienced outside financial and legal advisors, to rigorously examine potential transactions and transaction candidates through broad outreach to life sciences companies and a thorough process of evaluation of prospective strategic partners. The following is a summary of the background of the events leading up to the decision by Spring Bank to engage in a strategic combination, the process undertaken by Spring Bank to identify and evaluate prospective partners, and the negotiation of the Exchange Agreement and other Exchange-related documentation with F-star.
Spring Bank is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of a range of cancers and inflammatory diseases using its small molecule nucleotide platform. Spring Bank designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. Spring Banks internally-developed programs are primarily designed to stimulate and/or dampen immune responses.
As part of the ongoing consideration and evaluation of its long-term prospects and strategies, the board of directors of Spring Bank (the Spring Bank Board) frequently reviews, together with Spring Banks management team and outside advisors, strategic and financial alternatives in light of developments in Spring Banks business, the sectors in which it competes, the economy generally and financial markets, all with the goal of seeking to enhance stockholder value through the development of therapeutics for the treatment of diseases with high unmet medical needs. As part of this process, from time to time, members of Spring Banks management team and/or its advisors have engaged in business development and/or strategic discussions with industry participants, in consultation with the Spring Bank Board.
Until January 2020, Spring Bank had been developing inarigivir soproxil, an investigational orally-administered RIG-I agonist compound, as a potential treatment for chronic Hepatitis B virus (HBV). In April 2019, Spring Bank launched two Phase 2b global trials (CATALYST 1 and CATALYST 2) examining the administration of inarigivir 400mg as monotherapy and co-administered with a nucleotide analogue in naïve and virally suppressed chronic HBV patients. Inarigivir had also been the subject of a Phase 2 trial conducted by Gilead Sciences Inc. to evaluate the safety, efficacy and pharmacodynamics of escalating doses (50mg, 200mg and 400mg) of inarigivir co-administered with Gilead Sciences Vemlidy® (tenofovir alafenamide 25mg) for the treatment of chronic HBV infection.
On December 26, 2019, Spring Bank announced that it had stopped dosing and enrolling patients in its Phase 2b CATALYST trials and all other inarigivir studies due to clinical findings observed in the CATALYST 2 trial of virally-suppressed chronic HBV patients. At that time, laboratory findings revealed that three subjects participating in this trial showed evidence of hepatocellular dysfunction and an elevation of alanine transaminase (ALT) potentially consistent with liver injury rather than immune flares.
On January 21, 2020, at a special telephonic meeting, the Spring Bank Board met in consultation with its management team and representatives of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Mintz), outside
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counsel to Spring Bank. At this meeting, the Spring Bank Board and management team discussed at length the adverse events observed in the Companys CATALYST 2 chronic HBV trial, which had been suspended in December 2019, and the potential path forward for the Companys inarigivir/HBV program. The Spring Bank Board agreed that the regulatory path to approval of inarigivir would require lengthy additional clinical trials that would require substantial capital and time to complete. Coupled with Spring Banks aging patent estate in Asia, one of the largest potential markets for inarigivir, the Spring Bank Board concluded that it was in the best interests of Spring Bank and its stockholders to discontinue the development of inarigivir for the treatment of HBV. The Spring Bank Board also had a preliminary discussion of strategic options, including potential cost-saving measures, with the Spring Bank management team.
On January 29, 2020, Spring Bank announced that all clinical development of inarigivir for the treatment of HBV was being terminated due to the occurrence of unexpected serious adverse events, including one patient death, in Spring Banks Phase 2b CATALYST 2 trial. Spring Bank announced that it would be undertaking measures to streamline operations and reduce its cost structure, while continuing to focus on advancing the clinical development of its STING agonist program and the preclinical development of its STING antagonist program. Following this announcement, Martin Driscoll, Spring Banks President and CEO, and members of the Spring Bank Board engaged in further discussions relating to potential measures to preserve Spring Banks cash while seeking to maximize stockholder value.
In January and February 2020, Spring Bank engaged in preliminary and informal strategic combination discussions with several companies that had contacted Spring Bank after seeing the announcement regarding inarigivir on January 29, 2020.
On January 29, 2020, the Chief Business Officer of Company A contacted Mr. Driscoll to inquire about Spring Banks potential interest in a strategic combination between the two firms. The two firms executed a Confidential Disclosure Agreement following this phone discussion.
On February 7, 2020, Mr. Driscoll and a member of the Spring Bank Board affiliated with Company B had a phone discussion to discuss the concept of a potential strategic combination of Spring Bank and Company B. The Spring Bank director and Mr. Driscoll agreed that the Spring Bank director would introduce Mr. Driscoll to the CEO of Company B for further discussions regarding a potential strategic combination. The Spring Bank director and Mr. Driscoll agreed that the Spring Bank director would make the introduction to the CEO of Company B and then would not be involved in further direct participation or substantive discussions between the two companies regarding a potential transaction. Subsequent communications led to the scheduling of a meeting at the office of Company B during the week of February 24, 2020.
On February 13, 2020, Mr. Driscoll and the CEO and Chief Business Officer of Company A held a telephone call to discuss the respective attributes of each company and the concept of a potential strategic combination of the two firms. The parties agreed to meet again on February 25, 2020 at Company As office.
On February 14, 2020, an investment bank unaffiliated with Spring Bank presented Mr. Driscoll and Mr. Jonathan Freve, Spring Banks former Chief Financial Officer, with an unsolicited list of private companies that might be interested in a potential strategic combination with Spring Bank. The investment bank facilitated a confidential discussion on March 2, 2020 among the CEO and COO of Company D and members of the Spring Bank management team. The team at Company D stated an interest in the pursuit of a potential strategic combination with Spring Bank.
On February 25, 2020, Mr. Driscoll met with members of the management team of Company A at Company As office. Company As management team presented the capabilities of Company A and some preliminary ideas on the structure of a potential combination with Spring Bank.
On February 28, 2020, Mr. Driscoll met with the CEO of Company B at Company Bs office. A Confidentiality Agreement was entered into between Spring Bank and Company B prior to the commencement of the meeting. The Spring Bank director affiliated with Company B participated in the introduction of the meeting via conference call but left the call once introductions were completed. Management teams for both parties discussed a broad range of topics related to a potential strategic combination by the parties.
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On March 4, 2020, Mr. Driscoll met with the CEO of Company C. Mr. Driscoll had been introduced to the CEO of Company C by an independent member of the Spring Bank Board. Mr. Driscoll and the CEO of Company C held a non-confidential discussion about a potential research collaboration and a potential strategic combination of the parties.
In February and March 2020, multiple conference calls were held with parties that had contacted Spring Bank after seeing the announcement regarding inarigivir on January 29, 2020 to discuss potential strategic combination opportunities including corporate synergies related to products and operations.
During late February and early March 2020, Spring Banks management team engaged in discussions with multiple investment banking firms regarding a potential engagement as financial advisor to the Spring Bank Board to assist Spring Bank in conducting a broad strategic review of its options.
On March 3, 2020, Spring Bank reduced its workforce by approximately 30%, primarily reducing its research and development department.
On March 5, 2020, at a regularly scheduled, in-person meeting, the Spring Bank Board met in consultation with Spring Banks management team and representatives of Mintz. At this meeting, the Spring Bank Board discussed the impact of the discontinuation of Spring Banks HBV program and strategic alternatives for Spring Bank going forward. The strategic review included a discussion of all reasonable options to maximize value for Spring Bank stockholders, including market opportunities and regulatory and clinical hurdles for Spring Banks assets, the viability of remaining a stand-alone company, advancing the STING agonist program beyond the current Phase 1a/1b clinical trial, possible business combinations with other oncology-related companies, and seeking a strategic combination with a privately-held life sciences company, with Spring Banks stock being the consideration in the transaction. Mr. Driscoll explained the risks inherent to Spring Banks current stand-alone strategy, including a lack of near-term catalysts combined with a potential need to raise significant capital in the first half of 2021. Mr. Driscoll also noted that Spring Banks low market capitalization/public float significantly impacted Spring Banks ability to conduct a public offering to raise sufficient capital using Spring Banks existing shelf registration statement due to limitations applicable to smaller public companies such as Spring Bank. In particular, Mr. Driscoll noted that if Spring Bank were to raise sufficient capital to develop Spring Banks SB 11285 clinical program and conduct the necessary IND-enabling activities for the lead STING antagonist development candidate as a stand-alone company, the cost of capital and resulting dilution to existing Spring Bank stockholders would be substantial. Mr. Driscoll also provided a summary of the in-bound interest that the Spring Bank management team had received from multiple companies and the specific nature of these preliminary discussions. Mr. Driscoll also noted that, following the discontinuation of inarigivir and Spring Banks HBV programs, two equity research analysts had discontinued covering Spring Bank, which could make it more difficult for Spring Bank to conduct a financing to fund its continuing development programs. The attractiveness of a potential strategic combination was supported by the lack of value that the marketplace appeared to assign to Spring Banks remaining non-cash assets, in contrast to the value that Spring Banks public listing and cash might have to a high-quality merger candidate seeking to advance its own clinical programs. Further, he noted that a potential strategic combination or reverse merger transaction of this kind could provide Spring Bank stockholders with a meaningful stake in a combined organization possessing both promising clinical prospects and the means to pursue them, establishing the potential for long-term value creation for Spring Bank stockholders. In addition, representatives of Mintz and Mr. Garrett Winslow, Spring Banks General Counsel and Corporate Secretary, discussed the fiduciary duties of the Spring Bank Board relating to a strategic combination process. The Spring Bank Board also discussed the retention of a financial advisor to assist with the review of strategic alternatives, and the Spring Bank Board requested that the Spring Bank management team continue discussions with potential financial advisors to assist the Spring Bank Board or a special committee thereof an evaluation of strategic alternatives, and provide a recommendation to the Spring Bank Board or special committee on the engagement of a financial advisor. Following the Spring Bank Board meeting, Spring Banks management team continued discussions with multiple financial advisors with expertise in mergers and acquisitions in the pre-commercial biotechnology industry.
At the time, there were many clinical stage life sciences companies seeking to access the public markets to raise capital and create a public trading market for their securities. As a result, the Spring Bank Board believed
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that high-quality private life sciences companies could be actively seeking strategic combinations with a company like Spring Bank, and that Spring Bank had an opportunity to deliver value to its stockholders in this manner if it could identify and select a suitable candidate in a timely manner and manage its cash and other resources accordingly pending the consummation of a transaction. For these reasons, the Spring Bank Board focused its efforts on a search to identify such strategic combination candidates.
On March 5, 2020 and March 9, 2020, Mr. Driscoll had follow-up discussions with the CEOs of Company B and Company A, respectively.
On March 10, 2020, following an introduction by one of Spring Banks investment banking contacts, Mr. Driscoll held a call with the CEO of Company E, a publicly traded company. Company E was interested in the exploration of a potential strategic combination with Spring Bank. The two parties entered into a Confidential Disclosure Agreement following the call.
As of March 16, 2020, considering, among other things, that one Spring Bank Board member was an affiliate of a company that was expected to participate in the strategic alternatives review process, the efficiency and agility of a special committee, the time-savings to the full Spring Bank Board, and the independence as to management, the Spring Bank Board approved the establishment of a committee(the Special Committee) consisting of directors David Arkowitz, Todd Brady, MD, Ph.D., and Kurt Eichler, each of whom is an independent and disinterested director of Spring Bank, to assist the Spring Bank Board in considering, evaluating, reviewing and negotiating a range of strategic alternatives focused on seeking to maximize stockholder value and to make recommendations to the Spring Bank Board concerning whether to pursue or reject a potential strategic combination.
On March 19, 2020, the Special Committee held a telephonic meeting to discuss the purpose of the committee and to allow Spring Banks management team to summarize the discussions that they had had with potential financial advisors that could represent the Special Committee. Based on the work completed by the management team, the Special Committee determined to engage Ladenburg, in light of their broad experience with recent strategic combination and reverse merger transactions involving life science companies, as well as the competitiveness of their fee. Mr. Winslow briefly reviewed the fiduciary duties of the Special Committee and, suggested that the Special Committee consider engaging independent legal counsel to advise the Special Committee on the proposed strategic transaction process. The Special Committee requested that Mr. Winslow interview and assist with engaging independent legal counsel to advise the Special Committee.
On March 20, 2020, the Special Committee signed an engagement letter with Ladenburg to act as the independent financial advisor to the Special Committee to assist in the review of Spring Banks business and assets, and to explore strategic opportunities for enhancing stockholder value, including a potential strategic combination. In connection with Ladenburgs engagement, Mr. Driscoll requested that Ladenburg assume responsibility for coordinating further interactions with the management teams at Company A, Company B, Company E and Company D as part of the formal process.
On March 20, 2020, a Confidentiality Agreement was entered into between Spring Bank and Company F. The Spring Bank management team informed Company F that Ladenburg had been engaged to act as financial advisor and that further communications should generally take place with and through Ladenburg.
On March 20, 2020, the Special Committee engaged Heyman Enerio Gattuso & Hirzel LLP (Heyman Enerio) to act as independent special counsel to the Special Committee.
On March 24, 2020, the Spring Bank management team had a telephonic discussion with representatives from Ladenburg. The parties discussed the general strategic combination and reverse merger process, including preparation of a net cash analysis and the process and timeline for reaching out to prospective bidders.
On March 27, 2020, the Special Committee held a telephonic meeting with a representative of Heyman Enerio, during which such representative confirmed the independence of each director, discussed the retention of Ladenburg as the Special Committees independent financial advisor, and reviewed the Special Committees role and responsibilities. At this meeting, Mr. Arkowitz was elected to serve as the Special Committee Chairperson.
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Beginning in late March 2020 and throughout April 2020, Ladenburg contacted on a no-name basis a broad selection of private and public companies in the life sciences industry, including companies considering going public through an initial public offering, companies that had recently completed financing rounds with known crossover investors, and companies that were pursuing the development of product candidates in therapeutic areas garnering significant attention from life science investors, publicly traded ex-U.S. companies seeking a Nasdaq listing and also public companies in the U.S. that were believed to have a strategic fit with Spring Bank. Ladenburg targeted companies that would have a legitimate interest in continuing the development of Spring Banks STING agonist clinical development program. As part of this process, Ladenburg contacted a total of 375 companies. Ladenburg requested that indications of interest be submitted to it by April 30, 2020. During March and April, as part of the strategic process, Spring Bank granted access to the Spring Bank dataroom to 12 parties.)
In evaluating potential candidates, Ladenburg focused on companies with: (i) a legitimate interest in continuing the development of Spring Banks STING agonist development program, (ii) a perceived lower financing risk at closing, (iii) a strong product pipeline with multiple mid-to-late or commercial-stage assets, (iv) strong anticipated news flows, (v) an experienced management team, (vi) high-quality existing investors or new investors willing to support a potential transaction, (vii) a capital structure with no debt or a path to restructuring existing debt, and (viii) audited financial statements or the ability to produce audited financial statements for the last two fiscal years (collectively, the Specified Criteria.). Prospective strategic partners were removed from consideration if they failed to meet the components of the Specified Criteria, particularly if their valuation was considered to be unsupported and too high, they possessed a single asset in a high-risk space, they represented a significant financing risk, or their management team was not deemed to be as prepared to operate as a publicly traded company following a potential transaction.
On April 8, 2020, the Special Committee held a telephonic meeting with representatives from Heyman Enerio and Ladenburg. Ladenburg reviewed timelines for a potential strategic transaction, including the Specified Criteria. Ladenburg recommended a process to identify potential counterparties, starting with Ladenburg broadly disseminating an anonymous interest solicitation to potential transaction partners and gatekeeping organizations (such as venture capital firms, institutional investors, consultants, lawyers, bankers and investor relations firms), which process was already underway. Following receipt of an indications of interest, potential transaction partners would execute a confidentiality agreement in order to receive from Ladenburg the identity of Spring Bank and a formal process letter to solicit non-binding indications of interest, which were to include certain information regarding such candidates business, the proposed transaction structure, sources of financing, and detailed support for such candidates valuation, among other items. Following the receipt of such indications of interest from candidates, the Special Committee, with assistance requested from the Spring Bank management team, would review and select a subset of candidates to progress to in-person presentations to members of the Special Committee so that the Special Committee could select a finalist with which to negotiate a definitive agreement.
On April 8, 2020, the Spring Bank Board held a telephonic meeting in which Spring Banks management team provided an update to the Spring Bank Board on recent developments in the strategic combination process.
On April 15, 2020, the Special Committee met with Heyman Enerio and discussed the role, powers and fiduciary duties of the Special Committee.
By early May 2020, 33 companies had submitted indications of interest in a transaction with Spring Bank, including F-star. Each of these companies had entered into a confidentiality agreement with Spring Bank. These companies clinical programs were focused on a variety of indications and markets. Spring Banks management team, along with representatives from Ladenburg, reviewed each of these proposals in detail and evaluated the candidates based on their profiles and the Specified Criteria noted above.
Other than confidentiality agreements entered into by Spring Bank prior to the Special Committees engagement of Ladenburg, the confidentiality agreements entered into with these companies each contained a standard standstill provision, which restricted the proposed bidder from making a proposal to acquire Spring Bank that was not approved by the Spring Bank Board, for periods ranging from 12 18 months from the date of entry into the confidentiality agreement. However, none of the confidentiality agreements contained a so-called dont ask, dont waive provision, which would have prohibited the proposed bidder from asking Spring Bank to waive the standstill provision. Further, each of the confidentiality agreements also provided that the standstill
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provision would terminate upon the public announcement by Spring Bank of the entry into a definitive agreement for a merger or similar transaction with a third party, or upon the commencement of a tender offer by a third party for Spring Bank shares. As a result, Spring Banks management team believed that the standstill provisions would have no deterrent effect on the interest of a third party in making a bid to acquire Spring Bank after the announcement of the Exchange with F-star.
On May 6, 2020, the Special Committee held a telephonic meeting at which representatives of Ladenburg and the Spring Bank management team reviewed bids that had been received from potential strategic partners and discussed the process to date. David Strupp of Ladenburg then discussed the approach that Ladenburg and Spring Bank management had followed in evaluating the proposals and the Specified Criteria. Mr. Strupp shared the list of companies that provided proposals to Spring Bank and identified for the Special Committee the 15 companies that had been ranked as Tier A companies, including F-star. Mr. Strupp and Mr. Driscoll summarized the bids and clinical programs of each of those companies and presented a comparison of the financial terms proposed by each. The Special Committee, the Spring Bank management team and Ladenburg then collectively eliminated seven Tier A companies because these companies met fewer components of the Specified Criteria than the other eight companies that were chosen as finalists. The eight finalists represented companies focused on a variety of indications in the area of life sciences drug development, with a majority of the finalists focused on oncology. These eight initial finalist proposals offered Spring Bank stockholders post-closing stock ownership percentages ranging from 12.2% to 25.2% in the combined entities. Each of the finalists assumed for purposes of their respective bids that Spring Bank would have $17.0 million in cash at the closing of a transaction, assuming a transaction closing in early September 2020. The finalists initial bids valued the existing Spring Bank enterprise value between $9.0 million and $19.0 million with a mean of $13.6 million and a median of $13.7 million. Taken together with Spring Banks expected net cash, the finalists bids ascribed an aggregate value to Spring Bank in a range of amounts from $26.0 million to $36.0 million with a mean of $30.6 million and a median of $30.7 million.
On May 8, 2020, the Special Committee held a telephonic meeting with representatives of Heyman Enerio to discuss and decide upon the eight finalists. Ladenburg invited each of the eight finalists to make in-person management presentations to Spring Banks management team and the Special Committee on May 13 and 14, 2020. Each company was instructed to address specific, tailored due diligence or other follow-up questions, to prepare a detailed presentation covering certain topics and to refine the terms of their indications of interest, including valuation, financing plans and relative post-closing stock ownership percentages. Ladenburg engaged in discussions with each of the eight finalists via telephone to provide responses to diligence questions regarding Spring Bank.
On May 13 and 14, 2020, F-star, Company B, Company F, Company G, Company H, Company I, Company C and Company J presented virtually (as a result of the COVID-19 pandemic) to the Special Committee, Spring Bank management team and representatives of Ladenburg and Heyman Enerio. The purpose of the meetings was to evaluate the eight finalists and select from among them candidates to progress to the next stage of the process. The format of these meetings was interactive and consisted of the management team of each company presenting to the attendees for approximately 90 minutes, during which members of the Special Committee and the Spring Bank management asked questions.
Following the finalists presentations, on May 18, 2020, the Special Committee and the Spring Bank management team engaged in an extensive discussion regarding the benefits and drawbacks of each of the candidates. There was consensus amongst the parties that, at that time, it would not be in the best interests of Spring Bank stockholders to continue to evaluate Company C, given the determination by the participants in the discussion that a business combination with this prospect would not be as likely to create long-term stockholder value as a transaction with one of the other seven finalists. Some of the concerns expressed were related to the relative timing and prospects of its clinical programs, lack of multiple late-stage or commercial-stage assets, assessment of the depth and readiness of the companys management team to operate a publicly traded company, and the inability of the prospect to raise capital.
On the other hand, there was consensus on the part of the members of the Special Committee and the Spring Bank management team in favor of advancing discussions and diligence efforts with F-star, Company H and Company I. The Special Committee and Spring Banks management team expressed certain reservations regarding Company B, Company F, Company G and Company J, but agreed that it was in the best interests of
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Spring Bank stockholders to extend term sheets to these finalists because each party had select attributes that the Special Committee believed were necessary for an effective strategic combination.
On May 19, 2020, David Arkowitz resigned from the Special Committee as a result of other demands on his time but remained on the Spring Bank Board. Mr. Arkowitzs resignation from the Special Committee was not due to any disagreement on any matter relating to Spring Banks operations, policies, or practices. Following Mr. Arkowitzs resignation, the Special Committee continued as a two-person committee without a Chairperson.
On May 20, 2020, Ladenburg informed each of the finalists of the decisions of the Special Committee and Spring Bank management team. On behalf of Spring Bank, Ladenburg distributed to F-star, Company B, Company F, Company G, Company H, Company I and Company J a term sheet that had been created and agreed upon by representatives of Spring Bank, Ladenburg and Mintz. Each of these term sheets provided (i) that the proposed valuation ascribed to the third party in the strategic combination would be subject to adjustment based on the valuation ascribed to such third party in any separate or concurrent investment round and (ii) that the Spring Bank stockholders would benefit from a contingent value right related to Spring Banks ongoing clinical product candidate, SB 11285, or the STING Agonist CVR.
On May 20, 2020, the Spring Bank Board held a telephonic meeting in which Spring Banks management team and representatives of Ladenburg and Mintz participated. Spring Bank management and representatives of Ladenburg provided an update to the Spring Bank Board on recent developments in the strategic combination process and the deliberations that had taken place to select the finalists in the process.
On May 21, 2020, the Special Committee held a telephonic meeting with Heyman Enerio to discuss and approve the form of term sheet.
On May 26, 2020, Ladenburg informed the Special Committee and the Spring Bank management team that Company J would not be proceeding with responding to the draft term sheet due to significant management turnover.
On May 25, 2020, Mr. Driscoll spoke with the CEO of Company H, who indicated that Company H was in the process of negotiating two in-licensing deals, including raising the necessary capital to complete those transactions. Company Hs CEO advised Mr. Driscoll that, based on this shift in priorities, Company H would be unlikely to meet the timeline for responding to and completing a term sheet. Consequently, the Ladenburg and Spring Bank teams removed Company H from serious consideration as a potential transaction partner. Company H did not provide a revised term sheet to the Ladenburg or the Spring Bank team.
On May 27, 2020, F-star provided a revised term sheet to the Ladenburg team that (i) assigned an enterprise value to Spring Bank of $21 million, which was an increase of $3 million from F-stars initial bid proposal in April 2020, (ii) provided that F-stars shareholders would hold 71.4% of the combined company, assuming a $55 million pre-money valuation of F-star, a $40 million concurrent financing by F-star (with a condition for a minimum concurrent financing of $25 million, or the Pre-Closing Financing), (iii) eliminated the STING Agonist CVR and the ability for Spring Bank to realize any cash received from disposal of its legacy assets, and (iv) provided for a mutual 45-day exclusivity period.
Because F-star was also represented by Mintz, on May 29, 2020, Spring Bank retained Lowenstein Sandler LLP (Lowenstein) as special counsel, to represent Spring Bank in connection with negotiations with F-star.
During late May and early June 2020, the Ladenburg team, on behalf of the Special Committee, continued to have conversations with representatives from both Company G and Company B to determine whether either party would submit a viable counterproposal to the initial term sheet sent in mid-May 2020. On June 10, 2020, representatives from Company B informed Ladenburg that they needed additional time to speak with their investors and the Ladenburg team informed the Spring Bank management team and the Special Committee. Ladenburg also spoke with the representatives of Company G on June 10, and they informed Ladenburg that they would be sending a revised term sheet. Ladenburg had an additional conversation with the representatives from Company B on June 12 to inquire about the status of the term sheet. After discussing the options that were available, the Ladenburg and Spring Bank teams removed Company G and Company B from serious consideration. Company G sent a revised term sheet on June 17, 2020 after a decision was made to not move forward with them. Company B never provided a revised term sheet to the Ladenburg or Spring Bank teams.
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On June 1, 2020, on behalf of the Special Committee, the Ladenburg team provided a revised term sheet back to F-star that (i) assigned an enterprise value to Spring Bank of $23 million, (ii) provided that F-stars shareholders would hold 70.4% of the combined company following the strategic combination (with the same Pre-Closing Financing assumptions as noted above), (iii) included the STING Agonist CVR and provided for Spring Banks ability to dispose of legacy assets prior to the closing as part of the transaction, and (iv) provided for a mutual exclusivity period, with such term to be determined by the parties prior to executing the term sheet.
On June 2, 2020, Company I provided a revised term sheet to the Ladenburg team that (i) assigned an enterprise value to Spring Bank of $10 million, (ii) provided that Company Is stockholders would hold 88.7% of the combined company, assuming a $163.4 million pre-money valuation of Company I and a $48 million concurrent financing by Company I (with a condition for a minimum concurrent financing of $30 million), and (iii) included the STING Agonist CVR and Spring Banks ability to dispose of legacy assets prior to the closing as part of the transaction, but on significantly less favorable terms to Spring Bank than currently contemplated with F-star. The Special Committee and the Spring Bank management team (i) expressed concern over Company Is potential to deliver value from the STING Agonist CVR because Company I was not an oncology company and (ii) believed that Company I was significantly overstating its valuation, but ultimately determined to continue discussions and negotiations with Company I based on the belief that Company I had reasonable potential to successfully raise a significant amount of new capital to support the combined company.
On June 4, 2020, F-star provided a revised term sheet to the Ladenburg team. The parties agreed to set up a call for June 8, 2020 with representatives of Ladenburg, F-star and Spring Bank to discuss questions relating to the STING Agonist CVR, the proposed Pre-Closing Financing and the exclusivity period.
On June 4, 2020, Ladenburg, on behalf of Spring Bank, provided Company I with a revised term sheet which contemplated a Spring Bank enterprise valuation of $18 million and modifications to the STING Agonist CVR language.
On June 5, 2020, Ladenburg received a revised term sheet from Company F. Based on information conveyed by Ladenburg to Spring Bank, Spring Banks management team and the Special Committee expressed concern about Company Fs balance sheet and future ability to raise capital based on the concurrent financing plans proposed by Company F. The revised term sheet also included (i) a modified CVR that would have only been payable in shares of the combined companys common stock, rather than cash, and (ii) a 60-day exclusivity provision, which was considered to be unacceptably long in light of concerns about Company Fs ability to raise capital.
On June 8, 2020, representatives of Ladenburg, F-star and the Spring Bank management team met by teleconference to discuss the STING Agonist CVR, F-stars insider commitments related to the proposed Pre-Closing Financing and the duration of the exclusivity period.
On June 9, 2020, during a weekly update call at which the members of the Special Committee participated, representatives of Ladenburg and the Spring Bank management team discussed the status of term sheet discussions and negotiations. Spring Banks management team noted that it viewed Company F as a less attractive alternative than F-star and Company I based on the revised term sheet received by Spring Bank on June 5, 2020 and the view that Company Fs ability to raise sufficient capital to finance the combined company for a significant period of time was in doubt. Ladenburg discussed the benefits and drawbacks of both the F-star and Company I term sheets and Ladenburg indicated that it favored the F-star term sheet based on the significantly higher enterprise value attributed to Spring Bank and the increased likelihood of obtaining future value under the STING Agonist CVR based on F-stars experience in the immuno-oncology field and F-stars business development track record. The Spring Bank management team agreed with this assessment.
Later on June 9, 2020, Company I provided an updated term sheet to Ladenburg which contemplated an enterprise valuation of Spring Bank of $14.5 million, which would give Spring Bank and Company I stockholders 13% and 87% ownership, respectively, of the combined company. Based on feedback from Company I, Ladenburg indicated to the Spring Bank management team that it believed that Company I would not improve its terms beyond the updated term sheet.
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On June 11, 2020, representatives of Ladenburg, F-star and the Spring Bank management team met by teleconference to discuss further the STING Agonist CVR, F-stars insider commitments related to the proposed Pre-Closing Financing and the duration of the exclusivity period.
On June 12, 2020 and June 15, 2020, Spring Bank and F-star exchanged revised versions of the term sheet to finalize language on the Spring Bank valuation ($22.0 million), the STING Agonist CVR, net cash requirements and duration of exclusivity (30 days).
On June 15, 2020, the Spring Bank Special Committee held a telephonic meeting, at which representatives from Ladenburg and Spring Banks management team provided an update on term sheet discussions and negotiations with F-star and Company I. Following this discussion and an Executive Session of the Special Committee, the Special Committee approved Spring Bank entering into a term sheet with F-star, having determined that the terms negotiated by the Spring Bank management team provided the most value to Spring Banks stockholders. Later that day, Spring Bank and F-star executed a non-binding term sheet. Following execution of the term sheet, Ladenburg informed Company I, Company B and Company F that Spring Bank had executed a term sheet with a 30-day period of exclusivity with a third party and that, therefore, no further discussions would take place with other parties.
On June 17, 2020, representatives of Ladenburg, Lowenstein, as Spring Banks outside legal counsel, and Mintz, as F-stars outside legal counsel, discussed the process for preparing definitive agreements to reflect the terms in the term sheet.
On June 19, 2020, F-star provided access to its data room materials to Spring Bank and Lowenstein, with additional diligence materials added over the next few weeks.
Due diligence review of each of F-star and Spring Bank by the respective counterparty and their respective advisors began in June 2020 and continued throughout July 2020.
On June 24, 2020, the Spring Bank Board held a telephonic meeting in which Spring Banks management team provided an update to the Spring Bank Board on recent developments in the strategic combination process. The Spring Bank management team advised the Nominating and Corporate Governance Committee of the Spring Bank Board to consider the two Spring Bank directors that should continue as directors of the combined company.
On June 27, 2020, Spring Bank received a first draft of the Exchange Agreement from F-star.
On June 30, 2020, Spring Bank received a first draft of the STING Agonist CVR Agreement from F-star.
On July 2, 2020, Spring Bank received a first draft of the Voting Agreement from F-star.
Also, on July 2, 2020, Spring Bank provided its comments on the draft Exchange Agreement to F-star.
On July 6, 2020, Spring Bank provided comments on the draft STING Agonist CVR Agreement and the Voting Agreement to F-star.
On July 7, 2020, representatives of Spring Bank, Lowenstein and Mintz had a teleconference to discuss the draft Exchange Agreement.
On July 9, 2020, Spring Bank received a revised draft of the Exchange Agreement and a first draft of a Lock-Up Agreement from F-star. Spring Bank provided to F-star a first draft of Spring Banks disclosure schedules.
On July 9, 2020, Mr. Driscoll and Dr. Eliot Forster, F-stars CEO, spoke by telephone regarding potentially adding a term providing for the payment by F-star of a break-up fee to Spring Bank in the event that the strategic combination did not close as a result of F-star not completing an F-star Pre-Closing Financing resulting in gross proceeds of at least $25 million.
On July 9, 2020, Mr. Driscoll sent an e-mail to Dr. Forster summarizing the terms of a proposal received by Spring Bank from a third party relating to the development of Spring Banks STING antagonist program.
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On July 10, 2020, Mr. Driscoll and Dr. Forster spoke by telephone regarding the proposal referenced in the prior paragraph.
On July 10, 2020, Spring Bank provided comments on the revised draft of the Exchange Agreement and the draft Lock-up Agreement to F-star and received a revised draft of the STING Agonist CVR Agreement from F-star.
On July 11, 2020, Spring Bank received a memorandum from F-star describing the procedures pursuant to which F-star options and RSUs would be exchanged or otherwise treated in the Exchange and related matters. Spring Bank also received a first draft of the form of Equity Commitment Letter for the Pre-Closing Financing which, based on discussions with proposed investors, indicated that the F-star Pre-Closing Financing would be based on a pre-money valuation for F-star of $45.0 million, and not the $55.0 million indicated in the term sheet.
On July 12, 2020, representatives of Lowenstein and Mintz spoke by telephone to discuss the change in F-stars pre-money valuation and other matters relating to the Pre-Closing Financing and related matters.
On July 13, 2020, representatives of Ladenburg and Dr. Forster spoke by telephone and agreed that, as provided in the term sheet, F-stars pre-money valuation for purposes of the exchange ratio formula in the Exchange Agreement would be reduced to the $45.0 million value reflected in the draft form of Equity Commitment Letter, which had the impact of increasing Spring Banks stockholders percentage ownership in the combined company.
On July 13, 2020, Spring Bank provided comments on the revised draft of the STING Agonist CVR Agreement to F-star. In addition, Spring Bank received a first draft of the form of Subscription Agreement for the Pre-Closing Financing from F-star. Representatives of Spring Bank, Lowenstein and Mintz also held a teleconference to discuss the draft Exchange Agreement.
On July 14, 2020, the exclusivity period specified in the term sheet was extended to July 20, 2020. Also, on July 14, 2020, representatives of Spring Bank, Lowenstein, Mintz and Millis Reed, F-stars UK counsel, held a teleconference to discuss the procedures pursuant to which F-star options and RSUs would be exchanged or otherwise treated in the strategic combination and related matters.
Between July 14, 2020 and July 28, 2020, representatives of Spring Bank and F-star exchanged various drafts of the Spring Bank disclosure schedules.
On July 15, 2020, Spring Bank received a revised draft of the form of Lock-Up Agreement and a first draft of the Seller Lock-Up Agreement from F-star.
Between July 15, 2020 and July 16, 2020, representatives of Spring Bank, F-star, Lowenstein and Mintz exchanged various drafts of the Exchange Agreement, the STING Agonist CVR Agreement, the related Lock-Up Agreements and the form of Equity Commitment Letter and discussed the drafts.
On July 16, 2020, representatives of Spring Bank provided materials to the Special Committee, including a summary of the proposed terms of the Exchange Agreement. In addition, Mr. Driscoll provided an e-mail update to the Spring Bank Board regarding the progress of negotiations with F-star.
On July 17, 2020, the Special Committee held a telephonic meeting. Also attending the meeting were representatives of Spring Banks management team, Ladenburg, Heyman Enerio and Lowenstein. At the meeting, Mr. Driscoll provided a detailed update on the status of negotiations, the progress F-star was making with respect to the Pre-Closing Financing and related matters. A representative of Lowenstein provided a summary of the terms of the proposed Exchange Agreement. Spring Banks management team and professional advisors responded to questions from members of the Special Committee. Following the conclusion of the discussion, the Special Committee authorized Spring Banks management team to continue discussions with F-star.
Between July 17, 2020 and July 19, 2020, representatives of Spring Bank, F-star, Lowenstein and Mintz exchanged various drafts of the Exchange Agreement and the STING Agonist CVR Agreement and discussed the drafts.
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On July 19, 2020, Spring Bank received a first draft of the F-star disclosure schedules.
Between July 19, 2020 and July 28, 2020, representatives of Spring Bank and F-star exchanged various drafts of the F-star disclosure schedules.
On July 20, 2020, Mr. Driscoll and Dr. Forster spoke by telephone and discussed certain business issues related to the proposed terms of the Exchange. Also, on July 20, 2020, the exclusivity period in the term sheet was extended to July 23, 2020 and Spring Bank received a sample exchange ratio calculation from F-star. In addition, Spring Bank received a revised draft of the Exchange Agreement and related ancillary agreements from F-star. Spring Bank also received a proposed term sheet from F-star relating to a proposed bridge financing F-star was considering.
Between July 20, 2020 and July 23, 2020, representatives of Spring Bank, F-star, Lowenstein and Mintz exchanged various drafts of the Exchange Agreement and the STING Agonist CVR Agreement and discussed the drafts and related matters.
On July 21, 2020, Dr. Forster e-mailed Mr. Driscoll advising him, among other things, that F-star had agreed to lower its pre-money valuation to $35.0 million in its negotiations with investors regarding the Pre-Closing Financing, which had the impact of further increasing Spring Banks stockholders percentage ownership in the combined company.
On July 21, 2020, Spring Bank provided comments on the revised draft of the Exchange Agreement to F-star reflecting that, in connection with the Pre-Closing Financing, the pre-money valuation of F-star had been further reduced to $35.0 million. Spring Bank also provided to the Spring Bank Board a summary of a proposal under which Spring Bank would provide working capital funding to F-star prior to consummation of the Exchange in lieu of the proposed bridge financing F-star was considering.
On July 21, 2020, the Spring Bank Board met telephonically. Also participating in the telephonic meeting were representatives of Ladenburg and Lowenstein. Mr. Driscoll advised the directors that F-star had lowered its pre-money valuation to $35.0 million as a result of negotiations with potential investors in the Pre-Closing Financing and described the proposal pursuant to which Spring Bank would provide a working capital facility to F-star. Spring Banks management team and professional advisors responded to questions from the directors. Following the conclusion of the discussion, the Spring Bank Board authorized Spring Banks management team to make the working capital proposal to F-star. Thereafter, Mr. Driscoll sent the working capital proposal to Dr. Forster.
On July 22, 2020, Mr. Driscoll and Dr. Forster spoke by telephone during which Dr. Forster advised Mr. Driscoll that, as a result of an acceleration in the expected timing of third-party collaboration payments, F-star no longer needed to obtain a working capital facility. In addition, Dr. Forster advised Mr. Driscoll that F-star expected to have commitments for $21.5 million in investment prior to the entry into the Exchange Agreement.
Subsequent to this call, on July 22, 2020, representatives of Spring Bank and representatives of F-star discussed the expected timing of certain milestone events and the impact of the potential financing proceeds on the operations of the combined company following the Exchange. Mr. Driscoll provided an update to the Spring Bank Board on these matters.
On July 23, 2020, Mr. Driscoll and Dr. Forster spoke by telephone during which Dr. Forster advised Mr. Driscoll that F-star expected to have commitments for $14.5 million prior to the entry into the Exchange Agreement and expected to be able to raise more after executing the Exchange Agreement.
On July 24, 2020, Spring Bank provided to F-star a redacted summary of terms relating to the proposed development of the Companys STING antagonist program.
On July 24, 2020, since F-star had not yet obtained commitments for $25.0 million for the Pre-Closing Financing, Spring Bank provided notice to F-star that Spring Bank was exercising its right to terminate the exclusivity provisions of the term sheet effective immediately.
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On July 24, 2020, Dr. Forster e-mailed Mr. Driscoll with the terms of a new proposal approved by F-stars Board of Directors under which F-star would provide Spring Bank stockholders with a second contingent value right relating to Spring Banks STING antagonist program. In his e-mail, Dr. Forster stated that the revised documentation for the new proposal would have to be signed by 5:00 p.m. Eastern time on July 26, 2020 and announced before the markets opened in the U.S. on July 27, 2020.
In response to F-stars proposal, on July 24, 2020, Spring Banks management team, with assistance from Spring Banks financial and legal advisors, crafted a revised proposal which was described in an e-mail from Ladenburg to the Spring Bank Board, including the members of the Special Committee. Spring Banks revised proposal would (i) require F-star to share the risk that it does not raise at least $25.0 million in the Pre-Closing Financing by reducing F-stars pre-money valuation on a dollar-for-dollar basis for any shortfall in the $25.0 million target, (ii) accept F-stars proposal to provide a new STING antagonist CVR in addition to the STING Agonist CVR, but require F-star to retain 20% of the value generated from that program, as an incentive for F-star to effectively pursue potential future strategic collaborations for the program, (iii) reduce Spring Banks net closing cash target from $17.0 million to $16.0 million based on the new projected timing for closing the proposed Exchange, and (iv) give Spring Bank the right to designate an additional member of the Board of Directors of the combined company, for a total of three members (increased from two members).
On July 25, 2020, the Special Committee met telephonically to consider Spring Banks revised proposal. Also participating in the meeting were representatives of the Spring Bank management team, Ladenburg, Heyman Enerio and Lowenstein. Mr. Driscoll explained the revised proposal and the reasoning for the proposed terms. Spring Banks management team and representatives of Ladenburg and Lowenstein responded to questions from the members of the Special Committee. Following the conclusion of the discussion and an Executive Session of the Special Committee, the Special Committee authorized Spring Banks management team to make the revised proposal to F-star. Thereafter, Mr. Driscoll sent the revised proposal to Dr. Forster, and indicated that if F-star accepted the proposal, Spring Bank would reinstate the exclusivity provision in the term sheet until July 29, 2020 to permit the finalization of definitive documentation reflecting the new terms.
On July 26, 2020, Mr. Driscoll and Dr. Forster spoke by telephone during which Dr. Forster advised Mr. Driscoll that the F-star Board of Directors had met and accepted Spring Banks revised proposal.
Also on July 26, 2020, Spring Bank provided a revised draft of the Exchange Agreement and a first draft of the new STING antagonist CVR agreement (the STING Antagonist CVR Agreement) and together with the STING Agonist CVR Agreement, the CVR Agreements, to F-star.
Between July 26, 2020 and July 27, 2020, representatives of Spring Bank, F-star, Lowenstein and Mintz exchanged various drafts of the Exchange Agreement and the STING Antagonist CVR Agreement and discussed the drafts and related matters.
On July 27, 2020, representatives of Spring Bank provided a summary of the revised terms of the Exchange Agreement, Ladenburgs fairness opinion presentation and draft resolutions to the Spring Bank Board.
On July 27, 2020, the Spring Bank Board met telephonically. Also participating in the meeting were representatives of Spring Banks management team, Ladenburg and Lowenstein. Ladenburg presented its fairness opinion and analysis and answered questions from the Spring Bank Board. A representative of Lowenstein summarized the terms of the revised terms of the Exchange Agreement. Spring Banks management team and representatives of Ladenburg and Lowenstein provided additional details related to the Exchange and responded to questions from the directors. Certain members of the Spring Bank Board acknowledged that for Spring Bank to raise sufficient capital to develop its SB 11285 clinical program and to conduct the necessary IND-enabling activities for its lead STING antagonist development candidate as a stand-alone company, the cost of capital would have been extremely high and the resulting dilution to existing Spring Bank stockholders would have been greater than the dilution resulting from the Exchange. The Spring Bank Board also considered that two equity research analysts from investment banking firms that had previously led important equity financings for Spring Bank had recently ceased providing analyst coverage of Spring Bank. In light of these circumstances, the Spring Bank Board determined that a capital markets financing transaction was not likely to be successful.
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Following the conclusion of the discussion, the Spring Bank Board, by unanimous vote, determined that Exchange Agreement, the CVR Agreements and the proposed transactions with F-star were advisable and fair to, and in the best interests of, Spring Bank and its stockholders, approved the Exchange Agreement, the CVR Agreements and related matters, authorized Spring Banks management team to finalize, execute and deliver the transaction documents and recommended that Spring Bank stockholders approve the issuance of the shares of Spring Bank common stock as well as approve any other transactions contemplated by the Exchange Agreement. In addition, as recommended by the sole disinterested member of the Nominating and Corporate Governance Committee of the Spring Bank Board, the Spring Bank Board approved David Arkowitz, Todd Brady, M.D., Ph.D. and Pamela Klein, M.D. as the continuing directors of the combined company.
Between July 27, 2020 and July 29, 2020, representatives of Spring Bank, F-star, Lowenstein and Mintz exchanged various drafts of the Exchange Agreement and the STING antagonist CVR Agreement and discussed the drafts and related matters.
On July 28, 2020, Spring Bank received a revised sample exchange ratio calculation and a sample net cash calculation from F-star. Representatives of Spring Bank, Ladenburg and F-star discussed and agreed on sample calculations for the exchange ratio between July 28, 2020 and July 29, 2020.
On July 29, 2020, Spring Bank, F-star and the F-star equity holders executed and delivered the Exchange Agreement, and the entry into the Exchange Agreement was publicly announced.
Spring Bank Reasons for the Exchange
As described above, leading up to the approval of the Exchange Agreement, the Special Committee and the full Spring Bank Board of Directors undertook a comprehensive and thorough process to review and analyze potential strategic combination opportunities to identify an opportunity or transaction partner that would, in the Spring Bank Boards view, create the most value for the Spring Bank stockholders. In the course of its evaluation of the Exchange Agreement, the Special Committee held numerous meetings, consulted with Spring Banks management team, Spring Banks internal and outside lawyers and the Special Committees financial advisor, reviewed and assessed a significant amount of information, and considered a number of factors. This information was shared on a regular basis with all members of the Spring Bank Board to enable the Spring Bank Board to be fully informed in reaching its final decisions as to whether to authorize the execution and delivery of the Exchange Agreement. The information and factors considered in this evaluation included the following:
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the Spring Bank Boards belief that maintaining Spring Bank as an independent stand-alone company involved significant risk and the potential for significant dilution to the Spring Bank stockholders, taking into account Spring Banks business, operational and financial status and prospects, including its cash position, the substantially diminished price of the Spring Bank common stock following the termination of the clinical development of Spring Banks lead candidate (inarigivir), uncertainty regarding the successful clinical development of Spring Banks remaining clinical program, given its early stage of development, and the need to raise significant additional financing for the future development of Spring Banks remaining clinical product candidate in a volatile market; |
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the Spring Bank Boards belief, based in part on the judgment, advice and analysis of Spring Bank senior management with respect to the potential strategic, financial and operational benefits of the Exchange, that F-stars multiple promising clinical-stage therapeutic programs in the area of immuno-oncology, and the potential for near-term milestones, would result in a greater probability of providing value to Spring Banks stockholders than Spring Bank continuing as an independent stand-alone company; |
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that the Spring Bank stockholders could potentially receive significant future payments pursuant to the CVRs in the event of certain business development transactions involving Spring Banks STING agonist compound and its STING antagonist program during specified future periods; |
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the Spring Bank Boards consideration that the combined company would have sufficient cash from the Pre-Closing Financing and cash on hand to enable the combined company to implement its near-term |
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business plans or that Spring Bank stockholders would be compensated for any shortfall in the expected proceeds of the Pre-Closing Financing, and the fact that the combined company would have greater access to the public market to raise additional funds in the future; |
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the Spring Bank Boards belief that if Spring Bank were to raise sufficient capital to develop Spring Banks SB 11285 clinical program and conduct the necessary IND-enabling activities for the lead STING antagonist development candidate as a stand-alone company, the resulting dilution to existing Spring Bank stockholders would have been greater than the dilution resulting from the Exchange; |
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the Spring Bank Boards consideration of the valuation and business prospects of the other strategic combination candidates involved in its thorough strategic review process, and its collective view that F-star was the most attractive candidate for Spring Bank due to, among other things, F-stars belief that its tetravalent mAb2 bispecific antibodies may overcome many of the challenges facing current immuno-oncology therapies, and that F-stars potential to achieve key milestones over the next two years could enable the combined company to access the public markets for additional financial resources; |
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the Spring Bank Boards consideration that the combined company will be led by a senior management team from F-star experienced in immuno-oncology clinical drug development under the supervision of an experienced, well-qualified board of directors with representation from each of the current boards of directors of Spring Bank and F-star; |
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the limited amount of available cash that would be remain for distribution to Spring Bank stockholders in a potential dissolution and liquidation of Spring Bank, and the significant risks, costs and length of time involved in such a process; and |
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the Spring Bank Boards consideration of the financial analysis of Ladenburg and the opinion of Ladenburg delivered to the Spring Bank Board on July 27, 2020, to the effect that, as of the date of such opinion, and based upon and subject to the various assumptions made, procedures followed, matters considered and limitations and qualifications on the scope of the review undertaken by Ladenburg, as set forth in its written opinion, the Acquisition Consideration was fair, from a financial point of view, to Spring Bank stockholders as more fully described below under the caption The ExchangeOpinion of the Spring Bank Financial Advisor. |
The Spring Bank Board of Directors also reviewed the terms and conditions of the Exchange Agreement and the CVR Agreements, as well as the safeguards and protective provisions included in those documents that were intended to mitigate risks to Spring Bank and its stockholders, including:
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the sample Exchange Ratio used to establish the number of shares of Spring Bank common stock to be issued to F-star shareholders in the Exchange and presented to the Spring Bank Board was determined based on the relative valuations of the companies (including the anticipated proceeds of the Pre-Closing Financing), and thus the relative percentage ownership of Spring Bank stockholders and F-star shareholders immediately following the completion of the Exchange would be adjusted based on the amount of Spring Banks net cash and the actual amount of proceeds raised by F-star in the Pre-Closing Financing; |
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the limited number and nature of the conditions to F-stars obligation to consummate the Exchange and the limited risk of non-satisfaction of such conditions, as well as the anticipated likelihood that the Exchange will be consummated on a timely basis; |
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the respective rights of, and limitations on, Spring Bank and F-star under the Exchange Agreement to consider certain unsolicited acquisition proposals under certain circumstances, should Spring Bank or F-star receive a superior offer; |
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the reasonableness of the potential termination fee of $2.0 million and related reimbursement of certain transaction expenses of up to $750,000, and the fact that Spring Bank would be entitled to a termination fee of $2,.0 million in the event that the Exchange Agreement was terminated if the Pre-Closing Financing did not result in gross proceeds of at least the target amount set forth in the Exchange Agreement; |
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the Voting Agreements, pursuant to which certain directors, officers and certain stockholders of Spring Bank have agreed, solely in their capacity as stockholders of Spring Bank, to vote all of their shares of Spring Bank common stock in favor of the approval of the Exchange Agreement; and |
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the belief that the terms of the Exchange Agreement, including the parties representations, warranties and covenants, and the conditions to their respective obligations, are reasonable under the circumstances. |
In the course of its deliberations, the Spring Bank Board also considered a variety of risks and other countervailing factors related to entering into the Exchange, including:
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the $2.0 million termination fee and up to $750,000 in related expense reimbursement obligations payable by Spring Bank to F-star upon the occurrence of certain events and the potential effect of such fees in deterring other potential acquirers from proposing an alternative transaction that may be more advantageous to Spring Bank stockholders; |
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the substantial expenses to be incurred in connection with the Exchange, including the costs associated with any related litigation; |
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the possible volatility, at least in the short term, of the trading price of Spring Bank common stock resulting from the announcement of the Exchange; |
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the risk that the Exchange might not be consummated in a timely manner or at all and the potential adverse effect of the public announcement of the Exchange or delay or failure to complete the Exchange on the reputation of Spring Bank; |
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the likely detrimental effect on Spring Banks cash position, stock price and ability to initiate another strategic process and to successfully complete an alternative transaction should the Exchange not be completed; |
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the risk to Spring Banks business, operations and financial results in the event that the Exchange is not consummated, including the diminution of Spring Banks cash and the significant challenges associated with the need to raise additional capital through the public or private sale of equity securities; |
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the possibility of disruptive stockholder litigation following announcement of the Exchange; |
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the fact that F-stars product candidates are still in an early stage of clinical development, and accordingly are subject to the risk that they may not ever be successfully developed into products that can be marketed and sold; |
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the strategic direction of the combined company following the completion of the Exchange, which will be determined by a board of directors to be initially comprised of a majority of the directors designated by F-star; and |
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various other risks associated with the combined company and the Exchange, including those described in the section titled Risk Factors in this proxy statement/prospectus. |
The foregoing information and factors considered by the Spring Bank Board are not intended to be exhaustive but are believed to include all of the material factors considered by the Spring Bank Board. In view of the wide variety of factors considered in connection with its evaluation of the Exchange and the complexity of these matters, the Spring Bank Board did not find it useful to attempt, and did not attempt, to quantify, rank or otherwise assign relative weights to these factors. In considering the factors described above, individual members of the Spring Bank Board may have given different weight to different factors. The Spring Bank Board conducted an overall analysis of the factors described above, including thorough discussions with, and questioning of, Spring Banks management team, members of the Special Committee and the legal and financial advisors of the Special Committee, and considered the factors overall to be favorable to, and to support, its determination to approve the Exchange Agreement.
F-star Reasons for the Exchange
The following discussion sets forth material factors considered by the F-star Board of Directors in reaching its determination to approve the terms and authorize the execution of the Exchange Agreement for the purpose of
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implementing the Exchange; however, it may not include all of the factors considered by the F-star Board of Directors. In light of the number and wide variety of factors considered in connection with its evaluation of the Exchange Agreement, the F-star Board of Directors did not consider it practicable to, and did not attempt to, quantify or otherwise assign relative weights to the specific factors it considered in reaching its determination. The F-star Board of Directors viewed its position and determinations as being based on all of the information available and the factors presented to and considered by it. In addition, individual directors may have given different weight to different factors.
In the course of reaching its decision to approve the terms and authorize the execution of the Exchange Agreement for the purpose of implementing the Exchange, the F-star Board of Directors consulted with F-stars senior management and legal counsel, reviewed a significant amount of information and considered a number of factors, including, among others:
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historical and current information concerning F-stars business, including its financial performance and condition, operations, management and competitive position; |
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current industry and economic conditions and F-stars prospects if it were to remain an independent company, including its need to obtain additional financing and the terms on which it would be able to obtain such financing, if at all; |
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the cash resources of the combined company expected to be available at the Closing and the anticipated burn rate of the combined company; |
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the potential for increased access to sources of capital and a broader range of investors to support the development of F-stars product candidates than it could otherwise obtain if it continued to operate as a privately held company; |
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the potential to provide its current shareholders with greater liquidity by owning stock in a public company; |
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the expectation that the Exchange with Spring Bank would be a more time- and cost-effective means to access capital than other options considered; |
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the expectation that substantially all of F-star employees, particularly its management, will serve in similar roles at the combined company; |
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the terms and conditions of the Exchange Agreement, including, without limitation, the following: |
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the expected relative percentage ownership of Spring Banks stockholders and F-star shareholders in the combined company initially at the Closing and the implied valuation of F-star based on Spring Banks cash contribution to the combined company; |
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the parties representations, warranties and covenants and the conditions to their respective obligations; |
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the limited number and nature of the conditions of the obligation of Spring Bank to consummate the Exchange; and |
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the conclusion of the F-star Board of Directors that the potential termination fee of $2.0 million, less in specified circumstances the reimbursement of certain Exchange fees and expenses incurred in connection with the Exchange of up to $750,000, payable by Spring Bank to F-star, and the potential termination fee of $2.0 million payable by F-star to Spring Bank, and the circumstances when such fees may be payable, were reasonable; |
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the expectation that the Exchange will be treated as a reorganization for U.S. federal income tax purposes; |
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the ability to obtain a Nasdaq listing and the change of the combined companys name to F-star Therapeutics, Inc., upon the Closing; |
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the Voting Agreements, pursuant to which certain directors, officers and stockholders of Spring Bank have agreed, solely in their capacity as stockholders of Spring Bank to vote all of their shares of Spring Bank common stock in favor of approval of the Exchange Agreement; and |
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the likelihood that the Exchange will be consummated on a timely basis. |
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F-star Board of Directors also considered a number of uncertainties and risks in its deliberations concerning the Exchange and the other Exchanges contemplated by the Exchange Agreement, including the following:
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the risk that the potential benefits of the Exchange Agreement may not be realized; |
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the risk that future sales of common stock by existing Spring Bank stockholders may cause the price of Spring Bank common stock to fall, thus reducing the value of the consideration received by F-star shareholders in the Exchange; |
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the $2.0 million termination fee payable by F-star to Spring Bank in the event the Exchange Agreement is terminated by Spring Bank if the Pre-Closing Financing is terminated or does not occur prior to January 29, 2021 and the potential effect of such termination fee in deterring other potential acquirers from proposing an alternative Exchange that may be more advantageous to F-stars shareholders; |
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the price volatility of Spring Banks common stock, which may reduce the value of Spring Bank common stock that F-star shareholders will receive upon the Closing; |
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the potential reduction of Spring Banks net cash prior to closing; |
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the risk that the Pre-Closing Financing, which is a condition of the Exchange, is not completed; |
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the possibility that Spring Bank could under certain circumstances consider unsolicited acquisition proposals if superior to the Exchange; |
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the possibility that the Exchange might not be completed for a variety of reasons, such as the failure of Spring Bank to obtain the required stockholder vote, and the potential adverse effect on the reputation of F-star and the ability of F-star to obtain financing in the future in the event the Exchange is not completed; |
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the potential effect of the Exchange Agreement, including restrictions on F-stars ability to solicit alternative Exchanges, in deterring other potential acquirers from proposing an alternative Exchange that may be more advantageous to F-stars shareholders; |
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the risk that the Exchange might not be consummated in a timely manner or at all; |
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the fact that the representations and warranties in the Exchange Agreement do not survive the Closing and the potential risk of liabilities that may arise post-closing; |
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the expenses to be incurred in connection with the Exchange and related administrative challenges associated with combining the organizations; |
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the additional expenses that F-stars business will be subject to as a public company following the Closing to which it has not previously been subject; and |
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various other risks associated with the combined company and the Exchange, including the risks described in the section titled Risk Factors in this proxy statement/prospectus. |
The F-star Board of Directors weighed the benefits, advantages and opportunities of a potential Exchange against the uncertainties and risks described above, as well as the possible diversion of management attention for an extended period of time. After taking into account these and other factors, the F-star Board of Directors approved the terms and authorized execution of the Exchange Agreement for the purpose of implementing the Exchange.
Opinion of the Spring Bank Financial Advisor
As stated above, pursuant to an engagement letter dated March 20, 2020, the Special Committee retained Ladenburg to act as its financial advisor in connection with Spring Banks strategic transaction process and to render the opinion to the Spring Bank Board as to the fairness, from a financial point of view of the Acquisition Consideration (as defined in the Exchange Agreement) to the Spring Bank stockholders. On July 27, 2020, at the request of the Spring Bank Board, Ladenburg rendered the oral opinion, subsequently confirmed by delivery of the written opinion dated July 27, 2020, to the Spring Bank Board, that the Acquisition Consideration was fair, from a financial point of view, to Spring Bank stockholders as of the date of such Opinion and based upon the various assumptions, qualifications and limitations set forth therein.
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The full text of the Opinion is attached as Annex B to this proxy statement/prospectus and is incorporated by reference. Spring Bank encourages its stockholders to read the Opinion in its entirety for the assumptions made, procedures followed, other matters considered and limits of the review by Ladenburg. The summary of the Opinion set forth herein is qualified by reference to the full text of the Opinion. Ladenburg provided its opinion for the sole benefit and use by the Spring Bank Board in its consideration of the Exchange. The Opinion is not a recommendation to the Spring Bank Board or to any stockholder as to how to vote with respect to the proposed Exchange or to take any other action in connection with the Exchange or otherwise.
In connection with the Opinion, Ladenburg took into account an assessment of general economic, market and financial conditions as well as its experience in connection with similar transactions and securities valuations generally and, among other things:
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Reviewed a draft of the Exchange Agreement dated July 26, 2020, and a draft of the CVR Agreements. Both the Exchange Agreement and the CVR Agreements were the most recent drafts made available to Ladenburg prior to delivery of the Opinion; |
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Reviewed and analyzed certain publicly available financial and other information for each of Spring Bank and F-star, respectively, including equity research on comparable companies and on Spring Bank, and certain other relevant financial and operating data furnished to Ladenburg by the management of each of Spring Bank and F-star, respectively; |
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Reviewed and analyzed certain relevant historical financial and operating data concerning F-star furnished to Ladenburg by the management of F-star; |
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Discussed with certain members of the management of Spring Bank the historical and current business operations, financial condition and prospects of Spring Bank; |
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Reviewed and analyzed certain operating results of F-star as compared to operating results and the reported price and trading histories of certain publicly traded companies that Ladenburg deemed relevant; |
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Reviewed and analyzed certain financial terms of the Exchange Agreement and the CVR Agreements as compared to the publicly available financial terms of certain selected business combinations that Ladenburg deemed relevant; |
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Reviewed and analyzed certain financial terms of completed initial public offerings for certain companies that Ladenburg deemed relevant; |
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Reviewed certain pro forma financial effects of the Exchange; and |
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Reviewed and analyzed such other information and such other factors, and conducted such other financial studies, analyses and investigations, as Ladenburg deemed relevant for the purposes of the opinion. |
In conducting Ladenburgs review and arriving at Ladenburgs opinion, Ladenburg has, with Spring Banks consent, assumed and relied, without independent verification or investigation, upon the accuracy and completeness of all financial and other information provided to or discussed with Ladenburg by Spring Bank and F-star, respectively (or their respective employees, representatives or affiliates), or which is publicly available or was otherwise reviewed by Ladenburg. Ladenburg has not undertaken any responsibility for the accuracy, completeness or reasonableness of, or independent verification of, such information. Ladenburg has relied upon, without independent verification, the assessment of Spring Bank management and F-star management as to the viability of, and risks associated with, the current and future products and services of F-star (including without limitation, the development, testing and marketing of such products and services, the receipt of all necessary governmental and other regulatory approvals for the development, testing and marketing thereof, and the life and enforceability of all relevant patents and other intellectual and other property rights associated with such products and services). In addition, Ladenburg has not conducted, nor has Ladenburg assumed any obligation to conduct, any physical inspection of the properties or facilities of Spring Bank or F-star. Furthermore, Ladenburg has assumed, with Spring Banks consent, that there will be no adjustment to the Acquisition Consideration between the date of the Opinion and the date the final Acquisition Consideration is determined. Ladenburg has with
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Spring Banks consent, relied upon the assumption that all information provided to Ladenburg by Spring Bank and F-star is accurate and complete in all material respects. Ladenburg expressly disclaims any undertaking or obligation to advise any person of any change in any fact or matter affecting Ladenburgs opinion of which Ladenburg becomes aware after the date of the Opinion. Ladenburg has assumed there were no material changes in the assets, liabilities, financial condition, results of operations, business or prospects of Spring Bank or F-star since the date of the last financial statements made available to Ladenburg. Ladenburg has not obtained any independent evaluations, valuations or appraisals of the assets or liabilities of Spring Bank or F-star, nor has Ladenburg been furnished with such materials. In addition, Ladenburg has not evaluated the solvency or fair value of Spring Bank or F-star under any state or federal laws relating to bankruptcy, insolvency or similar matters. Ladenburgs opinion does not address any legal, tax or accounting matters related to the Exchange, as to which Ladenburg has assumed that Spring Bank and the Board of Directors have received such advice from legal, tax and accounting advisors as each has determined appropriate. Ladenburgs opinion addresses only the fairness of the Acquisition Consideration, from a financial point of view, to Spring Bank stockholders. Ladenburg expresses no view as to any other aspect or implication of the Exchange or any other agreement or arrangement entered into in connection with the Exchange. Ladenburgs opinion is necessarily based upon economic and market conditions and other circumstances as they exist and can be evaluated by Ladenburg on the date the opinion was delivered. It should be understood that although subsequent developments may affect Ladenburgs opinion, Ladenburg does not have any obligation to update, revise or reaffirm Ladenburgs opinion, and Ladenburg expressly disclaim any responsibility to do so.
Ladenburg did not assign any value to the right of the Spring Bank stockholders to receive contingent cash payments per the CVR Agreements, given Ladenburgs determination that any assumptions as to the probability of payment of the CVRs would be too speculative to use in Ladenburgs analysis of the value of such rights.
In addition, Ladenburgs opinion assumed a Pre-Closing Financing amount of $25.0 million at a pre-money valuation of F-Star, or the valuation of F-star prior to receiving any proceeds from the Pre-Closing Financing, of $35.0 million, and a valuation of Spring Bank of $38.0 million, which assumptions were provided to Ladenburg by the management of Spring Bank as of the date of the delivery of Ladenburgs opinion. Ladenburg noted that these items were subject to change based upon factors such as the actual amount raised by F-Star in the Pre-Closing Financing and Spring Banks net cash at Closing, but Ladenburg was not asked to, and did not, consider the impact of any such changes to the underlying assumptions at the time of its opinion.
Ladenburg did not consider any potential legislative or regulatory changes currently being considered or recently enacted by the United States or any foreign government, or any domestic or foreign regulatory body, or any changes in accounting methods or U.S. GAAP that may be adopted by the SEC, the Financial Accounting Standards Board, or any similar foreign regulatory body or board.
For purposes of rendering Ladenburgs opinion, Ladenburg has assumed in all respects material to Ladenburgs analysis, that the representations and warranties of each party contained in the Exchange Agreement are true and correct, that each party will perform all of the standards of the covenants and agreements required to be performed by it under the Exchange Agreement and CVR Agreements and that all conditions to the consummation of the Exchange will be satisfied without waiver thereof. Ladenburg has assumed that the final form of the Exchange Agreement and the CVR Agreements will be substantially similar to the last draft reviewed by Ladenburg. Ladenburg has also assumed that all governmental, regulatory and other consents and approvals contemplated by the Exchange Agreement and the CVR Agreements will be obtained and that in the course of obtaining any of those consents no restrictions will be imposed or waivers made that would have an adverse effect on the contemplated benefits of the Exchange. Ladenburg has assumed that the Exchange will be consummated in a manner that complies with the applicable provisions of the Securities Act, the Exchange and all other applicable federal and state statutes, rules and regulations. Spring Bank informed Ladenburg, and Ladenburg has assumed, that the Exchange is intended to constitute a reorganization within the meaning of Section 368(a) of the Code and the Treasury Regulations promulgated thereunder.
It is understood that Ladenburgs opinion is intended for the benefit and use of the Spring Bank Board in its consideration of the financial terms of the Exchange and, except as set forth in the engagement letter with Spring
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Bank, dated as of March 20, 2020 (the Engagement Letter), may not be used for any other purpose or reproduced, disseminated, quoted or referred to at any time, in any manner or for any purpose without Ladenburgs prior written consent, unless pursuant to applicable law or regulations or required by other regulatory authority by the order or ruling of a court or administrative body, except that Ladenburgs opinion may be included in its entirety in any filing related to the Exchange to be filed with the SEC and the proxy statement/prospectus to be mailed to Spring Bank stockholders. Ladenburgs opinion does not constitute a recommendation to the Spring Bank Board of whether or not to approve the Exchange or to any Spring Bank stockholders or any other person as to how to vote with respect to the Exchange or to take any other action in connection with the Exchange or otherwise. Ladenburgs opinion does not address Spring Banks underlying business decision to proceed with the Exchange or the relative merits of the Exchange compared to other alternatives available to Spring Bank. Ladenburg expressed no opinion as to the prices or ranges of prices at which shares or the securities of any person, including Spring Bank, will trade at any time, including following the announcement or consummation of the Exchange. Ladenburg was not requested to opine as to, and Ladenburgs opinion did not in any manner address, the amount or nature of compensation to any of the officers, directors or employees of any party to the Exchange, or any class of such persons, relative to the compensation to be paid to Spring Banks stockholders in connection with the Exchange or with respect to the fairness of any such compensation.
The issuance of the opinion was approved by a fairness opinion committee of Ladenburg. The opinion may not be published or otherwise used or referred to, nor shall any public reference to Ladenburg be made, without Ladenburgs prior written consent.
Principal Financial Analyses
The following is a summary of the principal financial analyses performed by Ladenburg to arrive at its opinion. Some of the summaries of financial analyses include information presented in tabular format. In order to fully understand the financial analyses, the tables must be read together with the text of each summary. The tables alone do not constitute a complete description of the financial analyses. Considering the data set forth in the tables without considering the full narrative description of the financial analyses, including the methodologies and assumptions underlying the analyses, could create a misleading or incomplete view of the financial analyses. Ladenburg performed certain procedures, including each of the financial analyses described below and reviewed with the Spring Bank Board the assumptions on which such analyses were based and other factors, including the historical and projected financial results of Spring Bank and F-star.
Exchange Overview as of the Date of the Opinion
Based upon an estimated Exchange Ratio of 0.5269 at the time of the signing of the Exchange Agreement, it was estimated that at the Closing: (a) the holders of F-star Shares immediately prior to the Exchange (including the holders of securities issued in the estimated $25.0 million Pre-Closing Financing) would hold approximately 61.2% of Spring Bank common stock outstanding immediately prior to the Exchange, and (b) the holders of Spring Bank securities immediately prior to the Exchange would hold approximately 38.8% of Spring Bank common stock outstanding, in each case, subject to adjustment of the Exchange Ratio as set forth in the Exchange Agreement and described herein.
Implied Equity Value
Ladenburg estimated an implied equity value for F-star of approximately $60 million, which was calculated by multiplying 53,031,115 (the shares of F-star outstanding including the holders of securities issued in the Pre-Closing Financing) by $1.13 (the implied price per share of F-star Common Stock). These combined shares represent the assumed F-star shares as of the signing of the Exchange Agreement (on a fully-diluted, as-converted basis and after giving effect to the Pre-Closing Financing).
Implied Total Enterprise Value
For purposes of the Opinion, Ladenburg calculated an implied total enterprise value for F-star of $35.0 million by subtracting an assumed F-star net cash balance of approximately $25.0 million (expected to be
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raised in the Pre-Closing Financing) from the implied equity value of approximately $60.0 million, which was based on F-stars projected indebtedness, cash and cash equivalents at closing.
Analysis of Selected Initial Public Offering Transactions
Ladenburg reviewed certain publicly available information for the IPOs of 28 immuno-oncology focused biopharmaceutical companies which have completed an IPO since February 2016 and whose lead product at the time of IPO was in Phase 1 through Phase 1/2 stage of clinical development. Although the companies referred to below were used for comparison purposes, none of these companies are directly comparable to F-star. Accordingly, an analysis of the results of such a comparison is not purely mathematical, but instead involves complex considerations and judgments concerning differences in historical and projected financial and operating characteristics of the selected companies below. These companies, which are referred to as the Selected Precedent IPO Companies, were:
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Aeglea BioTherapeutics, Inc. |
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Allogene Therapeutics, Inc. |
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ALX Oncology Holdings Inc. |
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AnaptysBio, Inc. |
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Arcus Biosciences, Inc. |
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Autolus Therapeutics plc |
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BeiGene, Ltd. |
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Bicycle Therapeutics plc |
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Corvus Pharmaceuticals, Inc. |
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Cue Biopharma, Inc. |
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Fusion Pharmaceuticals Inc. |
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Harpoon Therapeutics, Inc. |
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IDEAYA Biosciences, Inc. |
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iTeos Therapeutics, Inc. |
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Jounce Therapeutics, Inc. |
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Mersana Therapeutics, Inc. |
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Neon Therapeutics, Inc. |
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NextCure, Inc. |
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ORIC Pharmaceuticals, Inc. |
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Relay Therapeutics, Inc. |
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Replimune Group, Inc. |
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Revolution Medicines, Inc. |
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Surface Oncology, Inc. |
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Sutro Biopharma, Inc. |
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TCR2 Therapeutics Inc. |
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Turning Point Therapeutics, Inc. |
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Zentalis Pharmaceuticals, Inc. |
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Zymeworks Inc. |
The total enterprise value at IPO is defined as the pre-money equity value plus indebtedness, liquidation value of preferred stock and non-controlling interest, minus cash and cash equivalents at the time of its IPO. The Selected Precedent IPO Companies had total enterprise values between $46.2 million and $1,339 million. Ladenburg derived a median total enterprise value of $249.8 million for the Selected Precedent IPO Companies.
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Using the 25th percentile and the 75th percentile of the implied total enterprise values, Ladenburg then calculated a range of implied total equity values for F-star (by adding an estimated $25.0 million in cash at closing), which was $189.2 million to $392.5 million. This compares to F-stars implied equity value as per the Exchange Agreement of approximately $60.0 million.
Selected Precedent IPO Companies
First Trade Date |
Issuer |
Enterprise Value
($M) |
||||
7/24/2020 |
iTeos Therapeutics, Inc. |
$ | 286.4 | |||
7/17/2020 |
ALX Oncology Holdings Inc. |
402.5 | ||||
7/16/2020 |
Relay Therapeutics, Inc. |
1,002.1 | ||||
6/26/2020 |
Fusion Pharmaceuticals Inc. |
365.9 | ||||
4/24/2020 |
ORIC Pharmaceuticals, Inc. |
251.5 | ||||
4/6/2020 |
Zentalis Pharmaceuticals, LLC |
373.4 | ||||
2/13/2020 |
Revolution Medicines, Inc. |
593.1 | ||||
5/29/2019 |
NextCure, Inc. |
118.9 | ||||
5/24/2019 |
IDEAYA Biosciences, Inc. |
65.8 | ||||
5/23/2019 |
Bicycle Therapeutics plc |
127.7 | ||||
4/18/2019 |
Turning Point Therapeutics, Inc. |
266.3 | ||||
2/15/2019 |
TCR2 Therapeutics Inc. |
165.1 | ||||
2/8/2019 |
Harpoon Therapeutics, Inc. |
161.5 | ||||
10/11/2018 |
Allogene Therapeutics, Inc. |
1,339.3 | ||||
9/27/2018 |
Sutro Biopharma, Inc. |
194.5 | ||||
7/23/2018 |
Replimune Group, Inc. |
300.5 | ||||
6/28/2018 |
Neon Therapeutics, Inc. |
289.1 | ||||
6/22/2018 |
Autolus Therapeutics plc |
372.3 | ||||
4/20/2018 |
Surface Oncology, Inc. |
242.7 | ||||
3/16/2018 |
Arcus Biosciences, Inc. |
342.6 | ||||
12/21/2017 |
Cue Biopharma, Inc. |
48.4 | ||||
6/29/2017 |
Mersana Therapeutics, Inc. |
176.2 | ||||
4/28/2017 |
Zymeworks Inc. |
248.1 | ||||
1/27/2017 |
Jounce Therapeutics, Inc. |
125.4 | ||||
1/26/2017 |
AnaptysBio, Inc. |
221.1 | ||||
4/7/2016 |
Aeglea BioTherapeutics, Inc. |
46.2 | ||||
3/22/2016 |
Corvus Pharmaceuticals, Inc. |
231.5 | ||||
2/3/2016 |
BeiGene, Ltd. |
570.6 |
Analysis of Selected Publicly Traded Companies
Based on its experience and professional judgment and using financial screening sources and databases to find companies that share similar business characteristics to F-star within the biopharmaceutical industry, Ladenburg selected financial data of 34 publicly traded companies (the Selected Publicly Traded Companies). Each of the Selected Publicly Traded Companies had a lead candidate in Phase 1 through Phase 1/2 stage of clinical development and focused on the immuno-oncology space. Although the companies referred to below were used for comparison purposes, none of those companies is directly comparable to F-star. Accordingly, an analysis of the results of such a comparison is not purely mathematical but instead involves complex considerations and judgments concerning differences in historical and projected financial and operating characteristics of the selected companies below. The total enterprise values are based on closing stock prices on July 24, 2020. The Selected Publicly Traded Companies were:
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Advaxis, Inc. |
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Allogene Therapeutics, Inc. |
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ALX Oncology Holdings Inc. |
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Aptevo Therapeutics Inc. |
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Aravive, Inc. |
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Arvinas, Inc. |
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Atreca, Inc. |
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Autolus Therapeutics plc |
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Bicycle Therapeutics plc |
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Black Diamond Therapeutics, Inc. |
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Checkpoint Therapeutics, Inc. |
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Compugen Ltd. |
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Corvus Pharmaceuticals, Inc. |
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Cue Biopharma, Inc. |
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Cyclacel Pharmaceuticals, Inc. |
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Fate Therapeutics, Inc. |
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Fusion Pharmaceuticals Inc. |
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Genocea Biosciences, Inc. |
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Gritstone Oncology, Inc. |
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Harpoon Therapeutics, Inc. |
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IGM Biosciences, Inc. |
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iTeos Therapeutics, Inc. |
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Mersana Therapeutics, Inc. |
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Mustang Bio, Inc. |
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NextCure, Inc. |
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ORIC Pharmaceuticals, Inc. |
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Pieris Pharmaceuticals, Inc. |
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Relay Therapeutics, Inc. |
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Revolution Medicines, Inc. |
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Surface Oncology, Inc. |
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Sutro Biopharma, Inc. |
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TCR2 Therapeutics Inc. |
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Trillium Therapeutics Inc. |
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Zentalis Pharmaceuticals, Inc. |
The Selected Publicly Traded Companies had implied total enterprise values between ($6.0) million and $4,635.4 million. Ladenburg derived a median implied total enterprise value of $283.4 million for the Selected Publicly Traded Companies. Using the 25th percentile and the 75th percentile of the implied total enterprise values, Ladenburg then calculated a range of implied total equity values for F-star (by adding an estimated $25.0 million in cash at closing), which was $149.7 million to $961.9 million. This compares to F-stars implied equity value as per the Exchange Agreement of approximately $60.0 million.
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Selected Publicly Traded Companies
Company Name |
Enterprise Value
($M) |
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Allogene Therapeutics, Inc. |
$ | 4,635.4 | ||
Fate Therapeutics, Inc. |
2,473.0 | |||
Relay Therapeutics, Inc. |
2,428.8 | |||
IGM Biosciences, Inc. |
1,608.2 | |||
Arvinas, Inc. |
1,302.5 | |||
Revolution Medicines, Inc. |
1,273.5 | |||
Mersana Therapeutics, Inc. |
1,183.6 | |||
Zentalis Pharmaceuticals, LLC |
1,169.8 | |||
Compugen Ltd. |
968.4 | |||
ALX Oncology Holdings Inc. |
842.7 | |||
Black Diamond Therapeutics, Inc. |
622.9 | |||
Cue Biopharma, Inc. |
528.7 | |||
Trillium Therapeutics Inc. |
525.8 | |||
Autolus Therapeutics plc |
511.2 | |||
ORIC Pharmaceuticals, Inc. |
443.4 | |||
Harpoon Therapeutics, Inc. |
300.7 | |||
TCR2 Therapeutics Inc. |
284.0 | |||
Atreca, Inc. |
282.8 | |||
Fusion Pharmaceuticals Inc. |
278.0 | |||
iTeos Therapeutics, Inc. |
255.9 | |||
NextCure, Inc. |
233.9 | |||
Bicycle Therapeutics plc |
201.5 | |||
Sutro Biopharma, Inc. |
171.0 | |||
Genocea Biosciences, Inc. |
137.3 | |||
Surface Oncology, Inc. |
135.4 | |||
Pieris Pharmaceuticals, Inc. |
121.1 | |||
Checkpoint Therapeutics, Inc. |
105.7 | |||
Gritstone Oncology, Inc. |
104.7 | |||
Corvus Pharmaceuticals, Inc. |
99.4 | |||
Mustang Bio, Inc. |
98.8 | |||
Aravive, Inc. |
75.4 | |||
Aptevo Therapeutics Inc. |
17.5 | |||
Advaxis, Inc. |
15.1 | |||
Cyclacel Pharmaceuticals, Inc. |
(6.0 | ) |
Analysis of Selected Precedent M&A Transactions
Ladenburg reviewed the financial terms, to the extent the information was publicly available, of the 9 most recent qualifying acquisition transactions of companies in the biopharmaceutical industry, which had a lead candidate in Phase 1 through Phase 1/2 stage of clinical development and focused on the immuno-oncology space (the Selected Precedent M&A Transactions). Although the precedent transactions referred to below were used for comparison purposes, none of the target companies is directly comparable to F-star. Accordingly, an analysis of the results of such a comparison is not purely mathematical, but instead involves complex considerations and judgments concerning differences in historical and projected financial and operating characteristics of the companies involved and other factors that could affect the acquisition value of such companies and F-star to which they are being compared. Ladenburg reviewed the total enterprise values of the target companies (including downstream milestone payments). These transactions, including the date each was closed, were as follows below.
The Selected Precedent M&A Transactions had total implied enterprise values between $35.0 million and $4,622.6 million. Ladenburg derived a median total enterprise value of $535.0 million for the Selected Precedent
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M&A Transactions. Using the 25th percentile and the 75th percentile of the implied total enterprise values, Ladenburg then calculated a range of implied total enterprise values for F-star (by adding an estimated $25.0 million in cash at closing), which was $394.3 million to $600.0 million. This compares to F-stars implied equity value as per the Exchange Agreement of approximately $60.0 million.
Selected Precedent M&A Transactions
Closed Date |
Target |
Acquirer |
Implied Enterprise
Value ($M) |
|||||
3/2/2020 | Forty Seven Inc. | Gilead Sciences Inc. | $ | 4,622.6 | ||||
12/9/2019 | Synthorx Inc. | Sanofi S.A. | 2,308.8 | |||||
5/14/2018 | Aurka Pharma Inc. | Eli Lilly and Co. | 575.0 | |||||
9/6/2017 | Rigontec GmbH | Merck & Co. Inc. | 542.6 | |||||
11/16/2016 | Virttu Biologics Limited | TNK Therapeutics, Inc. | 35.0 | |||||
11/1/2016 | Kolltan Pharmaceuticals, Inc. | Celldex Therapeutics, Inc. | 369.3 | |||||
4/5/2016 | Cormorant Pharmaceuticals AB | Bristol-Myers Squibb | 520.0 | |||||
1/10/2016 | Tensha Therapeutics Inc. | Roche AG | 535.0 | |||||
10/21/2015 | Admune Therapeutics LLC | Novartis International AG | 258.0 |
Note Regarding Selected Initial Public Offering Transactions and Selected Precedent M&A Transactions
Based upon F-stars focus on developing products in the field of immuno-oncology and the stage of development of its product candidates, Ladenburg selected companies for these analyses specifically with a focus on immuno-oncology, with product development pipelines containing product candidates where the most advanced stage of clinical development was Phase 1 or Phase 1/2 at the time of their IPO or M&A transaction, respectively. Companies with pipeline assets in a more advanced stage of development were excluded by Ladenburg from its analysis. While there are no companies that were identical to F-star, Ladenburg determined that, given the similarity in both therapeutic focus and stage of development of the companies in the selected precedent transactions to F-star, these selected precedent companies would be the best benchmarks for valuation. As noted, the valuation ranges were large because Ladenburg applied no other criteria for further elimination. Ladenburg did not exclude any companies meeting the selection criteria from the analysis.
The summary set forth above does not purport to be a complete description of all the analyses performed by Ladenburg. The preparation of a fairness opinion involves various determinations as to the most appropriate and relevant methods of financial analysis and the application of these methods to the particular circumstances. Therefore, such an opinion is not readily susceptible to partial analysis or summary description. Ladenburg did not attribute any particular weight to any analysis or factor considered by it, but rather made qualitative judgments as to the significance and relevance of each analysis and factor. Accordingly, notwithstanding the separate factors summarized above, Ladenburg believes, and advised the Spring Bank Board, that its analyses must be considered as a whole. Selecting portions of its analyses and the factors considered by it without considering all analyses and factors could create an incomplete view of the process underlying its Opinion. In performing its analyses, Ladenburg made numerous assumptions with respect to industry performance, business and economic conditions and other matters, many of which are beyond the control of Spring Bank and F-star. These analyses performed by Ladenburg are not necessarily indicative of actual values or future results, which may be significantly more or less favorable than suggested by such analyses. In addition, analyses relating to the value of businesses do not purport to be appraisals or to reflect the prices at which businesses or securities may actually be sold. Accordingly, such analyses and estimates are inherently subject to uncertainty, being based upon numerous factors or events beyond the control of the parties or their respective advisors. None of Spring Bank, F-star, Ladenburg or any other person assumes responsibility if future results are materially different from those projected. The analyses supplied by Ladenburg and its opinion were among several factors taken into consideration by the Spring Bank Board in making its decision to enter into the Exchange Agreement and should not be considered as determinative of such decision.
Ladenburg was selected by the Special Committee of the Spring Bank Board to render an opinion to the Spring Bank Board because Ladenburg is a nationally recognized investment banking firm and because, as part
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of its investment banking business, Ladenburg is continually engaged in the valuation of businesses and their securities in connection with mergers, negotiated underwritings, secondary distributions of listed and unlisted securities, private placements and valuations for corporate and other purposes. In addition, in the ordinary course of its business, Ladenburg and its affiliates may trade the equity securities of Spring Bank for its own account and for the accounts of their customers, and, accordingly, may at any time hold a long or short position in such securities. In the two years preceding the date hereof, Ladenburg has not received any fees from Spring Bank, aside from the fees described below. In the two years preceding the date hereof, Ladenburg has not had a relationship with F-star and has not received any fees from F-star. Ladenburg and its affiliates may in the future seek to provide investment banking or financial advisory services to Spring Bank and F-star and/or certain of their respective affiliates and expect to receive fees for the rendering of these services.
Pursuant to the engagement letter between Ladenburg and Spring Bank as of the time the Exchange Agreement was approved, if the Exchange is consummated, Ladenburg will be entitled to receive a transaction fee of $900,000 payable in cash at the closing of the Exchange. Spring Bank has also paid Ladenburg an initial fee of $150,000 and an Opinion fee of $250,000 upon delivery of its Opinion. Additionally, Spring Bank has agreed to reimburse Ladenburg for its out-of-pocket expenses and has agreed to indemnify Ladenburg against certain liabilities, including liabilities under the federal securities laws. The terms of the fee arrangement with Ladenburg, which are customary in transactions of this nature, were negotiated at arms length between Spring Bank and Ladenburg, and the Special Committee was aware of the arrangement, including the fact that a portion of the fee payable to Ladenburg is contingent upon the completion of the Exchange.
Interests of the Spring Bank Directors and Executive Officers in the Exchange
In considering the recommendation of the Spring Bank Board with respect to the approval of the issuance of shares of Spring Bank common stock as contemplated by the Exchange Agreement, and the other matters to be acted upon by the Spring Bank stockholders at the Special Meeting, the Spring Bank stockholders should be aware that certain members of the Spring Bank Board and executive officers of Spring Bank have interests in the Exchange that may be different from, or in addition to, the interests of the Spring Bank stockholders. These interests relate to or arise from, among other things:
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severance and retention payments to which certain of Spring Banks executive officers will be entitled following completion of the Exchange as a result of termination of employment; |
|
the accelerated vesting of certain of the equity awards held by Spring Banks executive officers and directors in connection with the completion of the Exchange; and |
|
the fact that David Arkowitz, Todd Brady, M.D., Ph.D. and Pamela Klein, M.D., current directors of Spring Bank, will continue as directors of the combined company after the Closing. |
The Spring Bank Board was aware of these potential conflicts of interest and considered them, among other matters, in reaching their respective decisions to approve the Exchange Agreement and the Exchange, and to recommend, as applicable, that the Spring Bank stockholders approve the proposals to be presented to the Spring Bank stockholders for consideration at the Special Meeting as contemplated by this proxy statement/prospectus.
Ownership Interests
As of September 15, 2020, all current directors and executive officers of Spring Bank owned approximately 7.7% of the shares of Spring Bank common stock. The affirmative vote of a majority of the votes cast at the Special Meeting is required for approval of Proposal Nos. 1 and 4 (not counting abstentions or broker non-votes as votes cast). The affirmative vote of holders of a majority of the outstanding shares of Spring Bank common stock entitled to vote at the Special Meeting is required for approval of Proposal Nos. 2 and 3. Certain Spring Bank officers and directors, and their affiliates, have also entered into Voting Agreements in connection with the Exchange. For a more detailed discussion of the Voting Agreements, see the section titled Agreements Related to the ExchangeVoting Agreements in this proxy statement/prospectus, and for more information about the beneficial ownership of Spring Banks directors and executive officers, see the section titled Principal Stockholders of Spring Bank in this proxy statement/prospectus.
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Spring Bank Equity Awards
As of September 15, 2020, Spring Banks directors and current executive officers, collectively owned unvested Spring Bank option awards covering 297,026 shares of Spring Bank common stock and vested Spring Bank option awards covering 775,021 shares of Spring Bank common stock. Jonathan Freve and Nezam Afdhal, M.D., former executive officers of Spring Bank during Spring Banks fiscal year ending December 31, 2019 did not own any equity awards as of September 15, 2020.
All unvested issued and outstanding Spring Bank options and restricted stock units will be accelerated and vested in full immediately prior to the Closing and, following this acceleration, each option that has not previously been exercised will expire on the date of the Closing. The following table presents certain information, as of September 15, 2020, concerning outstanding Spring Bank equity awards held by Spring Banks directors and executive officers. The number of shares of Spring Bank common stock underlying these equity awards and the exercise prices for any issued and outstanding options will be appropriately adjusted to reflect the proposed reverse stock split to be implemented prior to the Closing. As of September 15, 2020, none of the options held by Spring Banks directors and executive officers were in-the-money, so no value has been attributed to them.
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Option Awards | Stock Awards | |||||||||||||||||||||||
Name |
Number of
Shares of Spring Bank Common Stock Underlying Unexercised Options (#) Exercisable |
Number of
Shares of Spring Bank Common Stock Underlying Unexercised Options (#) Unexercisable |
Option
Exercise Price ($) |
Option
Expiration Date |
Number
of Shares or Units That Have Not Vested (#) |
Market
Value of Shares or Units That Have Not Vested ($)(1) |
||||||||||||||||||
Current Executive Officers |
||||||||||||||||||||||||
Martin Driscoll |
295,047 | | $ | 12.88 | 8/16/2025 | | | |||||||||||||||||
President and Chief Executive Officer |
20,000 | | 10.97 | 5/18/2026 | | | ||||||||||||||||||
73,333 | 6,667 | 7.66 | 2/9/2027 | | | |||||||||||||||||||
51,667 | 28,333 | 12.10 | 1/15/2028 | | | |||||||||||||||||||
19,792 | 30,208 | 10.35 | 1/24/2029 | | | |||||||||||||||||||
| 40,000 | 1.41 | 3/5/2030 | |||||||||||||||||||||
100,000 | $ | 137,000 | ||||||||||||||||||||||
Lori Firmani |
10,000 | | 10.97 | 5/18/2026 | | | ||||||||||||||||||
Vice President of Finance and Treasurer |
3,667 | 333 | 7.66 | 2/9/2027 | | | ||||||||||||||||||
1,938 | 1,062 | 12.10 | 1/15/2028 | | | |||||||||||||||||||
1,979 | 3,021 | 10.35 | 1/24/2029 | | | |||||||||||||||||||
| 15,000 | 1.41 | 3/5/2030 | |||||||||||||||||||||
65,000 | $89,050 | |||||||||||||||||||||||
R. P. Kris Iyer, Ph.D. |
12,500 | | $ | 9.28 | 3/30/2025 | | | |||||||||||||||||
Chief Scientific Officer |
5,000 | | 10.97 | 5/18/2026 | | | ||||||||||||||||||
36,667 | 3,333 | 7.66 | 2/9/2027 | | | |||||||||||||||||||
25,833 | 14,167 | 12.10 | 1/15/2028 | | | |||||||||||||||||||
17,813 | 27,187 | 10.35 | 1/24/2029 | |||||||||||||||||||||
| 20,000 | 1.41 | 3/5/2030 | | | |||||||||||||||||||
70,000 | $95,900 | |||||||||||||||||||||||
Garrett Winslow, Esq. |
36,667 | 3,333 | $ | 7.86 | 1/3/2027 | | | |||||||||||||||||
General Counsel and Corporate |
11,625 | 6,375 | 12.10 | 1/15/2028 | | | ||||||||||||||||||
Secretary |
13,854 | 21,146 | 10.35 | 1/24/2029 | | | ||||||||||||||||||
| 25,000 | 1.41 | 3/5/2030 | |||||||||||||||||||||
75,000 | $ | 102,750 | ||||||||||||||||||||||
Current Directors |
||||||||||||||||||||||||
Scott Smith |
7,639 | 3,361 | $ | 11.34 | 8/15/2028 | | | |||||||||||||||||
Chairman of the Board |
7,500 | | 4.62 | 7/10/2029 | | | ||||||||||||||||||
1,250 | 6,250 | 1.60 | 6/24/2030 | | | |||||||||||||||||||
David Arkowitz |
10,000 | | $ | 9.28 | 3/30/2025 | | | |||||||||||||||||
Director |
5,500 | | 9.05 | 7/28/2026 | | | ||||||||||||||||||
5,500 | | 14.27 | 6/15/2027 | | | |||||||||||||||||||
5,500 | | 13.99 | 6/18/2028 | | | |||||||||||||||||||
7,500 | | 4.62 | 7/10/2029 | | | |||||||||||||||||||
1,250 | 6,250 | 1.60 | 6/24/2030 | | | |||||||||||||||||||
Todd Brady, M.D., Ph.D. |
11,000 | | $ | 9.05 | 7/28/2026 | | | |||||||||||||||||
Director |
5,500 | | 14.27 | 6/15/2027 | | | ||||||||||||||||||
5,500 | | 13.99 | 6/18/2028 | | | |||||||||||||||||||
7,500 | | 4.62 | 7/10/2029 | | | |||||||||||||||||||
1,250 | 6,250 | 1.60 | 6/24/2030 | | | |||||||||||||||||||
Timothy Clackson, Ph.D. |
9,167 | 1,833 | $ | 13.10 | 3/1/2028 | | | |||||||||||||||||
Director |
7,500 | | 4.62 | 7/10/2029 | | | ||||||||||||||||||
1,250 | 6,250 | 1.60 | 6/24/2030 | | | |||||||||||||||||||
Kurt Eichler |
5,000 | | $ | 12.88 | 8/20/2025 | | | |||||||||||||||||
Director |
5,500 | | 9.05 | 7/28/2026 | | | ||||||||||||||||||
5,500 | | 14.27 | 6/15/2027 | | | |||||||||||||||||||
5,500 | | 13.99 | 6/18/2028 | | | |||||||||||||||||||
7,500 | | 4.62 | 7/10/2029 | | | |||||||||||||||||||
1,250 | 6,250 | 1.60 | 6/24/2030 | | | |||||||||||||||||||
Pamela Klein, M.D. |
5,833 | 9,167 | 4.62 | 7/10/2029 | | | ||||||||||||||||||
Director |
1,250 | 6,250 | 1.60 | 6/24/2030 | | |
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(1) |
The value of any unvested stock awards was determined by multiplying the number of unvested shares subject to the award by $1.37 (the closing market price per share of Spring Banks common stock as of September 15, 2020). |
Exchange-Related Compensation of Current Executive Officers
As described below, Spring Banks executive officers have employment arrangements and retention agreements which provide that these executive officers are eligible to receive certain payments and benefits upon their respective termination of employment without cause or for good reason (each as defined in their respective employment and retention agreements). For purposes of calculating this compensation, Spring Bank has assumed that (i) each current executive officers employment will be terminated by Spring Bank without cause or by the executive for good reason upon the Closing, (ii) the Closing occurs prior to March 31, 2021 and (iii) Dr. Iyer receives $50,000 as the Iyer Bonus/Retention Amount. Jonathan Freve and Nezam Afdhal, M.D., former executive officers of Spring Bank, are not entitled to any compensation in connection with the Closing.
Cash |
COBRA
Benefits |
Total | ||||||||||
Martin Driscoll(1) |
$ | 556,875 | $ | 17,092 | $ | 573,967 | ||||||
R.P. Kris Iyer, Ph.D.(2) |
$ | 428,000 | $ | 21,585 | $ | 449,585 | ||||||
Lori Firmani(3) |
$ | 262,850 | $ | 28,081 | $ | 290,931 | ||||||
Garrett Winslow(4) |
$ | 395,694 | $ | 29,121 | $ | 424,815 |
(1) |
Pursuant to the employment agreement entered into on August 7, 2015 by and between Spring Bank and Mr. Driscoll, in the event that Mr. Driscolls employment is terminated by Spring Bank without cause or by Mr. Driscoll for good reason within one year of a change of control (including as a result of the Exchange), Spring Bank has agreed to continue to pay Mr. Driscoll his then-current base salary (currently $495,000) over a period of 12 months and to pay COBRA continuation premiums on his behalf for medical and dental benefits to him and covered members of his family for a period of up to 12 months. On March 5, 2020, the Spring Bank Board approved a retention arrangement for Mr. Driscoll, which provides that in the event of a termination without cause or a resignation for good reason (including in connection with the Exchange) prior to December 15, 2020, Mr. Driscoll will also be entitled to receive his unpaid retention award of ($61,875). |
(2) |
Pursuant to the employment agreement entered into on December 16, 2015 by and between Spring Bank and R.P. Kris Iyer, its chief scientific officer, in the event that Dr. Iyers employment is terminated by Spring Bank without cause or by Dr. Iyer for good reason within two years of a change of control (including as a result of the Exchange), Spring Bank has agreed to pay a lump sum payment equal to 12 months of his then-current base salary (currently $378,000 per year). On September 9, 2020, Spring Bank and Dr. Iyer entered into a Retention and Bonus Award Agreement pursuant to which Dr. Iyer will be eligible to receive, in connection with Spring Banks entry, prior to the Closing, into an agreement for the sale or license of Spring Banks STING antagonist assets, and contingent upon Dr. Iyers continuous employment through the Closing, a one-time, lump sum cash bonus equal to the lesser of (i) 5% of any upfront payment to Spring Bank for the sale or license of Spring Banks STING antagonist assets and (ii) $50,000 (the Iyer Bonus/Retention Amount). If Dr. Iyers employment is terminated prior to the Closing without cause or by Dr. Iyer for good reason and Spring Bank enters into an agreement for the sale or license of its STING antagonist assets prior to the Closing, Dr. Iyer will be eligible to receive the Bonus/Retention Amount. This Retention and Bonus Award Agreement will terminate on March 31, 2021 if the Closing has not occurred by March 31, 2021. |
(3) |
Pursuant to the employment agreement entered into on January 1, 2020 by and between Spring Bank and Lori Firmani, its Vice President of Finance and Treasurer, in the event that Ms. Firmanis employment is terminated by Spring Bank without cause or by Ms. Firmani for good reason within one year of a change of control (including as a result of the Exchange), Spring Bank has agreed to continue to pay Ms. Firmani her then-current base salary (currently $200,000) over a period of 12 months and to |
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pay COBRA continuation premiums on her behalf for medical benefits to her and covered members of her family for a period of up to 12 months. On March 5, 2020, the Spring Bank Board approved a retention arrangement for Lori Firmani, which provides that in the event of a termination without cause or a resignation for good reason (including in connection with the Exchange) prior to December 15, 2020, Ms. Firmani will be entitled to receive her unpaid retention award ($47,850). In addition, on September 9, 2020, Spring Bank and Ms. Firmani entered into a Retention and Bonus Award Agreement pursuant to which Ms. Firmani will receive a one-time, lump sum cash bonus of $15,000 should Ms. Firmani remain continuously employed with Spring Bank through the Closing and the Closing occurs by March 31, 2021. If Ms. Firmanis employment with Spring Bank is terminated prior to the Closing without cause or by Ms. Firmani for good reason, Ms. Firmani will be eligible to receive the $15,000 bonus payment. The Retention and Bonus Award Agreement will terminate on March 31, 2021 if the Closing has not occurred by March 31, 2021. |
(4) |
Pursuant to the employment agreement entered into on November 30, 2016 by and between Spring Bank and Garrett Winslow, its General Counsel and Corporate Secretary, in the event that Mr. Winslows employment is terminated by Spring Bank without cause or by Mr. Winslow for good reason within one year of a change of control (including as a result of the Exchange), Spring Bank has agreed to continue to pay Mr. Winslow his then-current base salary (currently $321,600) over a period of 12 months and to pay COBRA continuation premiums on his behalf for medical benefits to him and covered members of his family for a period of up to 12 months. On March 5, 2020, the Spring Bank Board approved a retention arrangement for Mr. Winslow, which provides that in the event of a termination without cause or a resignation for good reason (including in connection with the Exchange) prior to December 15, 2020, Mr. Winslow will be entitled to receive his unpaid retention award ($59,094). In addition, on September 9, 2020, Spring Bank and Mr. Winslow entered into a Retention and Bonus Award Agreement pursuant to which Mr. Winslow will receive a one-time, lump sum cash bonus of $15,000 should Mr. Winslow remain continuously employed with Spring Bank through the Closing and the Closing occurs by March 31, 2021. If Mr. Winslows employment with Spring Bank is terminated prior to the Closing without cause or by Mr. Winslow for good reason, Mr. Winslow will be eligible to receive the $15,000 bonus payment. The Retention and Bonus Award Agreement will terminate on March 31, 2021 if the Closing has not occurred by March 31, 2021. |
Indemnification and Insurance
For a discussion of the indemnification and insurance provisions related to the Spring Bank directors and officers under the Exchange Agreement, see the section titled Indemnification and Insurance below.
Interests of the F-star Directors and Executive Officers in the Exchange
F-star shareholders should be aware that certain members of the F-star Board of Directors and executive officers of F-star have interests in the Exchange that may be different from, or in addition to, interests they have as F-star shareholders. Certain of F-stars directors and executive officers currently hold F-star ordinary shares that will be converted into Spring Bank common stock. All of F-stars executive officers, its employee directors, and some of its non-employee directors have options to purchase F-star ordinary shares that will be converted into and become options to purchase shares of Spring Bank common stock. F-stars executive officers have restricted stock units and share options that will be converted into and become Spring Ban k restricted stock units. Certain of F-stars directors and executive officers are expected to become directors and executive officers of the combined company upon the Closing, and all of F-stars directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Exchange Agreement.
Ownership Interests
Certain of F-stars directors and executive officers currently hold F-star ordinary shares. The table below sets forth the anticipated ownership of F-star ordinary shares by F-stars directors and executive officers immediately prior to the Closing based on their ownership of F-stars ordinary shares as of September 15, 2020 and also any shares that the individual has the right to acquire within 60 days of September 15, 2020.
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Directors and Executive Officers |
F-star Share Capital
Beneficially Held Immediately Prior to the Closing |
|||
Eliot Forster, Ph.D.(1) |
348,779 | |||
Darlene Deptula-Hicks(2) |
101,070 | |||
Neil Brewis, Ph.D.(3) |
219,036 | |||
Louis Kayitalire, M.D.(4) |
87,324 | |||
Nessan Bermingham, Ph.D.(5) |
200,119 | |||
Edward Benz, M.D.(6) |
29,166 | |||
Jean-François Formela, M.D.(7) |
| |||
Deborah Harland, Ph.D.(8) |
| |||
Patrick Krol(9) |
| |||
Geoffrey Race(10) |
29,166 | |||
Helmut Schuehsler, Ph.D.(11) |
|
(1) |
Consists of (i) 164,978 ordinary shares, (ii) 27,308 shares issuable upon the exercise of options under the legacy GmbH Scheme exercisable within 60 days of September 15, 2020, and (iii) 156,493 shares issuable upon the exercise of options outstanding under the F-star EIP exercisable within 60 days of September 15, 2020. |
(2) |
Consists of 101,070 shares issuable upon the exercise of options under the F-star EIP exercisable within 60 days of September 15, 2020. |
(3) |
Consists of (i) 176,380 ordinary shares, (ii) 20,229 shares issuable upon the exercise of options under the legacy GmbH Scheme, and (iii) 22,427 shares issuable upon the exercise of options. |
(4) |
Consists of 87,324 shares issuable upon the exercise of options under the F-star EIP exercisable within 60 days of September 15, 2020. |
(5) |
Consists of 200,119 shares issuable upon the exercise of options under the F-star Therapeutics Limited 2018 Equity Incentive Plan exercisable within 60 days of September 15, 2020. This does not include share capital held by Atlas Venture Fund VII, L.P. or the ordinary shares issuable upon the conversion of the convertible notes held by Atlas Venture Opportunity Fund I, L.P. |
(6) |
Consists of 29,166 shares issuable upon the exercise of options under the F-star EIP exercisable within 60 days of September 15, 2020. |
(7) |
This does not include the share capital held by Atlas Venture Fund VII, L.P. or the ordinary shares issuable upon the conversion of the convertible notes held by Atlas Venture Opportunity Fund I., L.P. |
(8) |
This does not include the shares held by, or the ordinary shares issuable upon the conversion of the convertible notes held by, S.R. One, Limited, an indirect, wholly-owned subsidiary of GlaxoSmithKline plc. |
(9) |
This does not include the share capital held by, or the ordinary shares issuable upon the conversion of the convertible notes held by, Coöperatieve Aescap Venture I, U.A. |
(10) |
Consists of 29,166 shares issuable upon the exercise of options outstanding under the F-star EIP. |
(11) |
This does not include the share capital held by, or the ordinary shares issuable upon the conversion of the convertible notes held by, TVM Life Science Ventures VI GmbH & Co. KG and TVM Life Science Ventures VI L.P. |
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Certain F-star shareholders affiliated with F-stars directors also currently hold F-star share capital. The table below sets forth the anticipated ownership of F-star ordinary shares by affiliates of F-stars directors immediately prior to the Closing based on their ownership of F-star share capital as of September 15, 2020 and also any shares that the shareholders affiliated with F-stars directors have the right to acquire within 60 days of September 15, 2020.
Shareholder Name |
F-star Share Capital
Held Immediately Prior to the Closing |
|||
Entities affiliated with Atlas Venture Fund(1) |
8,757,901 | |||
Coöperatieve Aescap Venture I, U.A.(2) |
4,621,612 | |||
Entities affiliated with TVM Life Sciences(3) |
3,198,441 | |||
MP Healthcare Venture Management Inc.(4) |
2,140,923 | |||
Merck Ventures B.V.(5) |
3,044,044 | |||
S.R. One, Limited(6) |
5,463,723 |
(1) |
Consists of (i) 103,611 ordinary shares issuable upon conversion of Series Seed Preferred shares held by Atlas Venture Fund VII, L.P., (ii) 313,661 ordinary shares issuable upon conversion of Series A Preferred shares held by Atlas Venture Fund VII, L.P., (iii) 4,693,801 ordinary shares held by Atlas Venture Fund VII, L.P., and (iv) 3,646,828 ordinary shares issuable upon conversion of $4,300,247 of convertible notes, interest calculated as of November 14, 2020 held by Atlas Venture Opportunity Fund I, L.P. Atlas Venture Associates VII, L.P. (AVA VII LP) is the sole general partner of Atlas Venture Fund VII, L.P. Atlas Venture Associates VII, Inc. (AVA VII Inc.) is the sole general partner of AVA VII LP. Peter Barrett, Bruce Booth, Jeff Fagnan and Jean-Francois Formela are each directors of AVA VII Inc (collectively referred to as AVA Directors). Nessan Bermingham, Ph.D., a Venture Partner of Atlas Venture, and Jean-Francois Formela, M.D., a partner of Atlas Venture, are members of F-stars board of directors. Atlas Venture Associates Opportunity I, L.P. (AVAO I LP) is the sole general partner of Atlas Venture Opportunity Fund I, L.P. Atlas Venture Associates Opportunity I, LLC (AVAO I LLC) is the sole general partner of AVAO I LP. Bruce Booth, Kevin Bitterman, Jason Rhodes, David Grayzel and Jean-Francois Formela are each members of AVAO I LLC (collectively referred to as AVAO Members). Each of AVA VII LP, AVA VII Inc., the AVA Directors, AVAO I LP, AVAO I LLC, the AVA Members and Nessan Bermingham disclaim beneficial ownership of the shares, except to the extent of their proportionate pecuniary interest therein, if any. |
(2) |
Consists of (i) 302,880 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 3,407,025 ordinary shares, and (iii) 911,707 ordinary shares issuable upon conversion of $1,075,068 of convertible notes, interest calculated as of November 14, 2020. Hans Bosman, Michiel de Haan and Patrick Krol have a joint voting and investment power of the securities held by Coöperatieve Aescap Venture I, U.A. |
(3) |
Consists of (i) 130,778 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,471,079 ordinary shares held by TVM Life Science Ventures VI GmbH & Co. KG (TVM VI), (iii) 36,254 ordinary shares issuable upon conversion of Series A Preferred shares, (iv) 407,833 ordinary shares held by TVM Life Science Ventures VI L.P. (TVM VI LP), (v) 902,590 ordinary shares issuable upon conversion of $1,064,318 of convertible notes held by TVM VI, interest calculated as of November 14, 2020, and (vi) 249,807 ordinary shares issuable upon conversion of $294,569 of convertible notes, interest calculated as of November 14, 2020 held by TVM VI LP. Hubert Birner and Stefan Fischer are members of the investment committee of TVM Life Science Ventures Management VI L.P. (TVM VI Management), a special limited partner of each of TVM VI and TVM VI LP, with voting and dispositive power over the shares held by TVM VI and TVM VI LP. |
(4) |
Consists of (i) 100,353 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,128,863 ordinary shares, and (iii) 911,707 ordinary shares issuable upon conversion of $1,075,068 of convertible notes, interest calculated as of November 14, 2020. Jeffrey B. Moore, DPhil, MBA, President of MP Healthcare Ventures Inc., with approval from the MP Healthcare Venture Management Inc. board of directors, has voting and investment power of the securities held by MP Healthcare Venture Management Inc. |
148
(5) |
Consists of (i) 99,653 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,120,977 ordinary shares, and (iii) 1,823,414 ordinary shares issuable upon conversion of $2,150,137 of convertible notes, interest calculated as of November 14, 2020. Merck Ventures B.V. is an affiliate of Merck KGaA, Darmstadt, Germany. Merck Ventures B.V. is a wholly owned subsidiary of Merck B.V. Merck B.V. may be deemed to have sole voting and dispositive power with respect to the shares held by Merck Ventures B.V. Merck Ventures B.V. is a wholly owned indirect subsidiary of Merck KGaA, a publicly traded company (Frankfurt Stock Exchange, DAX 30). Merck KGaA may be deemed to have sole voting and dispositive power with respect to the shares held by Merck Ventures B.V. |
(6) |
Consists of (i) 148,333 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,668,562 ordinary shares, and (iii) 3,646,828 ordinary shares issuable upon conversion of $4,300,274 of convertible notes, interest calculated as of November 14, 2020. S.R. One, Limited, is an indirect, wholly-owned subsidiary of GlaxoSmithKline plc. GlaxoSmithKline plc has sole voting and investment power of the securities held by S.R. One Limited. |
Treatment of F-star Equity Awards
Prior to (and conditional upon and effective as of) the Closing, the Spring Bank Board will cause Spring Bank to assume the F-star EIP, and each holder of Original EIP Options will be granted a Replacement EIP Option, which will be an option to subscribe for or purchase shares of Spring Bank common stock. The vesting schedule and vesting dates applicable to each Replacement EIP Option will be the same as the vesting schedule and vesting dates applicable to the Original EIP Option that it replaces. The aggregate number of shares of Spring Bank common stock issuable on exercise in full of each Replacement EIP Option will be calculated by applying the Exchange Ratio to the number of F-star ordinary shares issuable on exercise in full of the Original EIP Option that it replaces, and rounding the resulting number down to the nearest whole number of shares of Spring Bank common stock. The aggregate exercise price payable to exercise in full each Replacement EIP Option will be the same as the aggregate exercise price payable to exercise in full the Original EIP Option that it replaces; provided, however, that the exercise price with respect to a Replacement EIP Option may be adjusted, as required by the Exchange Agreement, with respect to any option granted to a United States participant under the F-star EIP. Each holder of F-star restricted stock units will be granted a Replacement EIP RSU. Each Replacement EIP RSU will be granted under the Assumed Plan and will be a right to acquire shares of Spring Bank common stock. The number of shares of Spring Bank common stock issuable on vesting in full of each Replacement EIP RSU will be calculated by applying the Exchange Ratio to the number of F-star ordinary shares issuable on vesting in full of the Original EIP RSU that it replaces, and rounding the resulting number down to the nearest whole number of shares of Spring Bank common stock. The Replacement EIP RSUs and the Replacement EIP Options with respect to Original EIP Options granted to United States participants will be subject to the same terms and conditions as the Original EIP RSUs and Original EIP Options, respectively (except to the extent such terms are rendered inoperative as a result of the transactions contemplated by the Exchange Agreement), and will not provide holders of the Replacement EIP Options or Replacement EIP RSUs with any additional benefits that the holders did not have under their Original EIP Options or Original EIP RSUs. The F-star Board of Directors will offer the holders of Original EIP Options the choice to exchange their options for Replacement EIP Options and the holders of Original EIP RSUs the choice to exchange their RSUs for Replacement EIP RSUs on the terms set forth in the Exchange Agreement, as described above. If any holder of Original EIP Options that is an EMI Option (as defined in the rules of the F-star EIP), fails to accept the offer to exchange, the portion of their Original EIP Options that will be unvested as at the Closing will lapse immediately in accordance with the rules of the F-star EIP, and upon exercise of any portion of their Original EIP Options that will be bested as at the Closing, F-star will immediately exercise its right to procure the compulsory purchase of F-star ordinary shares. If any holder of an Original EIP RSU does not accept the offer to exchange, upon the vesting of such RSU, F-star will immediately exercise its right to procure the compulsory purchase of F-star ordinary shares in accordance with the articles of association of F-star.
Prior to the Closing, holders of F-star Legacy Options will be notified by the F-star Board of Directors that they may exercise their F-star Legacy Options conditional upon and effective at the Closing. If a holder of any F-star Legacy Option fails to exercise such options, such unexercised F-star Legacy Option will cease to be exercisable effective upon the Closing and will lapse six months following the Closing. If a holder of an F-star
149
Legacy Option elects to exercise such option and agrees to be bound by the Share Exchange Agreement, he or she will exchange the shares acquired on exercise of his or her F-star Legacy Option on the terms of the Share Exchange Agreement. If a holder of an F-star Legacy Option elects to exercise such option but does not agree to be bound by the Share Exchange Agreement, upon the exercise of such F-star Legacy Option, F-star will immediately exercise its right to procure the compulsory purchase of F-star ordinary shares issued upon such exercise.
The following table presents certain information concerning the outstanding F-star options and restricted stock units held by F-stars directors and current executive officers, as of September 15, 2020 and also any shares that the optionholder has the right to acquire within 60 days of September 15, 2020:
Optionholder Name |
Grant Date |
Expiration
Date |
Exercise Price |
Number of F-star
Ordinary Shares Underlying Options or RSUs as of September 15, 2020 |
Number of F-star
Ordinary Shares Underlying Options or RSUs Vested as of 60 Days from September 15, 2020 |
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Eliot Forster, Ph.D. |
10/1/2018 | | GBP 0.00017006 | 50,571 | 27,308 | |||||||||||||||
10/1/2018 | | GBP 0.01 | 289,803 | 156,493 | ||||||||||||||||
7/1/2020 | | GBP 0.01 | 2,030,000 | | ||||||||||||||||
Darlene Deptula-Hicks |
5/1/2019 | | USD 1.87 | 252,676 | 101,070 | |||||||||||||||
7/1/2020 | | | 235,000 | | ||||||||||||||||
Neil Brewis, Ph.D. |
11/2/2015 | | GBP 0.00042514 | 20,229 | 20,229 | |||||||||||||||
5/7/2019 | | GBP 0.01 | 56,068 | 22,427 | ||||||||||||||||
7/1/2020 | | GBP 0.01 | 625,000 | | ||||||||||||||||
Louis Kayitalire, M.D. |
6/17/2019 | | USD 1.87 | 242,569 | 87,324 | |||||||||||||||
7/1/2020 | | | 235,000 | | ||||||||||||||||
Nessan Bermingham, Ph.D.(1) |
4/1/2018 | | GBP 0.01 | 303,211 | 200,119 | |||||||||||||||
7/1/2020 | | | 150,000 | | ||||||||||||||||
Edward Benz, M.D. |
12/18/2019 | | USD 1.61 | 35,000 | 29,166 | |||||||||||||||
Geoffrey Race |
12/18/2019 | | GBP 0.01 | 35,000 | 29,166 |
Indemnification and Insurance
For a discussion of the indemnification and insurance provisions related to the F-star directors and officers under the Exchange Agreement, see the section titled Indemnification and Insurance below.
Management Following the Exchange
As described elsewhere in this proxy statement/prospectus, including in the section titled Management Following the Exchange, certain of F-stars directors and executive officers are expected to become the directors and executive officers of Spring Bank upon the Closing.
Indemnification and Insurance
Under the Exchange Agreement and subject to applicable law, from the Closing through the sixth anniversary of the date of Closing, each of Spring Bank and the combined company will indemnify and hold harmless each person who is now, or has been at any time prior to the date of the Exchange Agreement, or who becomes prior to the Closing, a director or officer of Spring Bank or F-star, respectively, against all costs incurred in connection with any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, arising out of or pertaining to the fact that such person is or was a director or officer of Spring Bank or F-star, whether asserted or claimed prior to, at or after the Closing, in each case, to the fullest extent permitted under the DGCL for directors or officers of Delaware corporations, provided that such officer or director acted in good faith and in a manner such party reasonable believed to be in or not opposed to
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the best interest of Spring Bank or the combined company, as applicable, and, with respect to any criminal proceeding, such officer or director had no reasonable cause to believe such conducted was unlawful; provided, further, that, if applicable law so provides, no indemnification against such costs will be made in respect of any claim, issue or matter in such proceeding as to which the director or officer will have been adjudged to be liable to Spring Bank or the combined company unless and to the extent that the Court of Chancery of the State of Delaware will determine that such indemnification may be made. Subject to applicable law, each such director and officer will be entitled to advancement of expenses incurred in the defense of any such claim, action, suit, proceeding or investigation from each of Spring Bank and the combined company, jointly and severally, upon receipt by Spring Bank or the combined company from such director or officer of a request therefor; provided that any such person to whom expenses are advanced provides an undertaking to Spring Bank or the combined company, as applicable, to the extent then required by the DGCL, to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
From and after the Closing, (i) the combined company will fulfill and honor in all respects the obligations of F-star to each person who is or has served as a director or officer of F-star as of immediately prior to the Closing pursuant to any indemnification provisions under the F-star certificate of incorporation or F-star bylaws and pursuant to any indemnification agreements between F-star and such directors and officers, with respect to claims arising out of matters occurring at or prior to the Closing (ii) Spring Bank will fulfill and honor in all respects the obligations of Spring Bank to each person who is or has served as a director or officer of Spring Bank as of immediately prior to the Closing pursuant to any indemnification provisions under Spring Banks amended and restated certificate of incorporation or Spring Banks bylaws and pursuant to any indemnification agreements between Spring Bank and such directors and officers that were in effect prior to the date of the Exchange Agreement, with respect to claims arising out of matters occurring at or prior to the Closing.
The Exchange Agreement also provides that Spring Bank will maintain directors and officers liability insurance policies commencing at the Closing, on commercially available terms and conditions with coverage limits customary for U.S. public companies similar situated to Spring Bank. In addition, Spring Bank will purchase, prior to the Closing, a six-year prepaid D&O tail policy for the non-cancellable extension of the directors and officers liability coverage of Spring Banks existing directors and officers insurance policies and Spring Banks existing fiduciary liability insurance policies, in each case, for a claims reporting or discovery period of at least six years from and after the Closing.
Additionally, F-star will obtain run-off tail endorsements to its current directors and officers insurance policies (or runoff or tail policies of at least the same coverage containing terms and conditions no less advantageous to the current and all former directors and officers of F-star) with respect to acts or failures to act prior to the Closing. Spring Bank will (at F- stars expense) maintain products liability and human clinical trial liability insurance policies for Spring Bank and its subsidiaries with an effective date as of the Closing, on commercially available terms and conditions and with coverage limits customary for U.S. public companies similarly situated to Spring Bank, and providing coverage for bodily injury or property damage caused by Spring Bank or its subsidiaries products, including bodily injury or property damage occurring in connection with human clinical trials, anywhere in the world. In addition, prior to the Closing, Spring Bank will purchase and fully pre-pay (at F-stars expense) a tail endorsement to Spring Banks existing global products liability and human clinical trial liability insurance policy that provides a six-year extended reporting period from and after the Closing for claims for alleged bodily injury or property damage that occurred prior to the Closing in connection with any of the Acquiring Companies (as defined in the Exchange Agreement) products, including any alleged bodily injury or property damage occurring in connection with human clinical trials (the Clinical Trial Tail). In the event the Clinical Trial Tail is not available to be purchased from the Spring Banks existing global products liability and human clinical trial liability insurer, then Spring Bank will obtain and fully pre-pay (at F-stars expense) the premium for products liability and human clinical trial liability insurance which would be the equivalent of the Clinical Trial Tail with coverage that is substantially equivalent to and in any event not less favorable than Spring Banks current existing products liability and human clinical trial liability insurance and which cannot be cancelled for any reason.
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From and after the Closing, Spring Bank will pay all expenses, including reasonable attorneys fees, that are incurred by indemnified persons in connection with their successful enforcement of the rights provided to such persons in the Exchange Agreement. The director and officer indemnification provisions of the Exchange Agreement are intended to be in addition to the rights otherwise available to the current and former officers and directors of Spring Bank and F-star by law, charter, statute, bylaw or agreement, and will operate for the benefit of, and will be enforceable by, each of such indemnified persons, their heirs and their representatives.
In the event Spring Bank or the combined company or any of their respective successors or assigns (i) consolidates with or merges into any other person and will not be the continuing or surviving corporation or entity of such consolidation or merger, or (ii) transfers all or substantially all of its properties and assets to any person, then, and in each such case, proper provision will be made so that the successors and assigns of Spring Bank or the combined company, as the case may be, will succeed to the indemnification obligations set forth in the Exchange Agreement. Spring Bank will cause the combined company to perform all of the director and officer indemnification obligations of the combined company under the Exchange Agreement.
Form of the Exchange
The Exchange Agreement provides that at the Closing, Spring Bank will acquire the entire issued and outstanding share capital of F-star.
After completion of the Exchange and upon approval of Proposal No. 3 to effect the Spring Bank Name Change, the combined company will take the name F-star Therapeutics, Inc. and expects to trade on the Nasdaq Capital Market under the symbol FSTX.
Exchange Consideration and Adjustment
At the Closing, each outstanding ordinary share of F-star will be sold to Spring Bank in exchange for a number of shares of Spring Bank common stock determined by the Exchange Ratio formula set forth in the Exchange Agreement, subject to certain adjustment and to account for the anticipated Reverse Stock Split. Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation, or the valuation of F-star prior to receiving any proceeds from the Pre-Closing Financing, of at least $35.0 million), the holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion and the F-star Pre-Closing Financing) are expected to own approximately 61.2% of the outstanding capital stock of the combined company. Based on the assumptions above, the Spring Bank securityholders are expected to own approximately 38.8% of the combined company, subject to adjustment in certain circumstances as described below.
Immediately prior to the Closing, in the F-star Share Conversion, all of the issued and outstanding Seed Preference Shares and Series A Preference Shares of F-star will convert into ordinary shares of F-star, and, in the F-star Note Conversion, all outstanding F-star convertible loan notes will convert into ordinary shares of F-star The F-star Share Conversion and the F-star Note Conversion are referred to herein, collectively, as the Conversions.
The Exchange Ratio is calculated based on the total number of shares of Spring Bank and F-star deemed to be outstanding immediately prior to the Closing and each of Spring Banks and F-stars respective valuations.
Spring Banks outstanding shares will be the total number of shares of Spring Bank common stock outstanding immediately prior to the Closing expressed on a fully-diluted basis and calculated using the treasury stock method, assuming, without limitation or duplication, (a) the exercise of each Spring Bank option outstanding and unexercised immediately prior to the Closing that has an exercise price less than or equal to the then current trading price for shares of Spring Bank common stock (i.e., in-the-money options), excluding any portion thereof which cannot become vested or exercisable or will otherwise not be outstanding immediately after the Closing; and (b) the exercise of each Spring Bank warrant outstanding and unexercised immediately prior to the Closing that has an exercise price less than or equal to the then current trading price for shares of Spring Bank common stock (i.e., in-the-money warrants) and will be outstanding immediately after the
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Closing, subject to certain exceptions for Spring Bank warrants to purchase 250,000 shares of common stock that are exercisable at $2.08 per share.
F-stars outstanding shares will be the total number of F-star ordinary shares outstanding immediately prior to the Closing expressed on a fully-diluted basis and calculated using the treasury stock method, assuming, without limitation or duplication, (i) the Conversions, (ii) the exercise of all F-star options outstanding as of immediately prior to the Closing, (iii) the issuance of F-star ordinary shares upon the vesting of all F-star restricted stock units outstanding as of immediately prior to the Closing, (iv) the consummation of the Pre-Closing Financing and the issuance of F-star ordinary shares pursuant to the Pre-Closing Financing Agreements (as defined in the Exchange Agreement), and (v) the issuance of F-star ordinary shares in respect of all other options, warrants or rights to receive F-star ordinary shares that will be outstanding immediately prior to the Closing.
Spring Banks valuation has been determined to be $38 million, which amount is subject to adjustment in the event that Spring Banks net cash as of immediately prior to the Closing is less than $15.0 million or greater than $17.0 million, in which case, Spring Banks valuation would be decreased or increased, respectively, on a dollar-for-dollar basis by the amount Spring Banks actual net cash is less than $15.0 million or greater than $17.0 million, respectively. If the Closing occurs after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. The assumed valuations and Exchange Ratio are likely to change, and the parties currently expect the Closing to occur during the fourth quarter of 2020.
F-stars valuation is the sum of the lesser of the pre-money valuation attributed to F-star for purposes of the Pre-Closing Financing and $35.0 million, minus the amount, if any, by which $25.0 million exceeds the aggregate subscription amount for which F-star has received executed equity commitment letters as of the 10th day preceding the Special Meeting, plus the proceeds actually received by F-star in the Pre-Closing Financing.
The Exchange Ratio is calculated based on the respective allocation percentages for Spring Bank and F-star. Spring Banks allocation percentage is the quotient of Spring Banks valuation, as adjusted as described above, divided by the Aggregate Valuation. F-stars allocation percentage is the quotient of F-stars valuation, as adjusted as described above, divided by the Aggregate Valuation.
The Pre-Closing Financing
Concurrently with the execution of the Exchange Agreement, certain existing investors of F-star, pursuant to binding equity commitment letters by and between each investor and F-star, agreed to subscribe in a private placement of ordinary shares as of immediately prior to the Closing (the Pre-Closing Financing). The Pre-Closing Financing is expected to be completed in accordance with Regulation D as promulgated under the Securities Act. As of , 2020, F-star had received commitments from investors to purchase $ million of ordinary shares of F-star in the Pre-Closing Financing, including commitments to purchase $ in ordinary shares of F-star from certain of F-stars executive officers, directors and principal stockholders. F-star may continue to seek additional commitments in the Pre-Closing Financing until 11:59 p.m., Eastern time on the 10th day prior to the Special Meeting. Ordinary shares of F-star issued in the Pre-Closing Financing will be exchanged for shares of Spring Bank common stock at the Exchange Ratio in the Exchange. See the section titled The ExchangeInterests of F-star Directors and Executive Officers in the Exchange in this proxy statement/prospectus.
Determination of Spring Banks Net Cash
For purposes of determining the Exchange Ratio, Spring Banks net cash will be calculated as of the close of business on the last day before the anticipated closing date as follows:
Spring Banks cash and cash equivalents and marketable securities
A. Plus:
|
in the event Spring Bank enters into a definitive agreement for a proposed transaction for Spring Banks STING antagonist program on or prior to the Closing, an amount equal to any upfront payments |
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that, as of the Closing, are earned by Spring Bank, such amount not to exceed $2.0 million; |
|
certain prepaid expenses and deposits, up to an aggregate amount of $2.0 million and subject to certain limitations; and |
|
expenses paid, or liabilities incurred, by Spring Bank or any of its subsidiaries prior to the Closing that are approved in writing to be paid to Spring Bank or any of its subsidiaries pursuant to any directors and officers insurance policies in excess of the deductible thereunder. |
B. Minus:
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all accounts payable and accrued expenses and any other current and long-term liabilities of Spring Bank or any of its subsidiaries; |
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any reserves for legal settlements, except to the extent such amounts are covered by insurance policies; |
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the cash cost of any unpaid change of control payments or severance, termination or similar payments or obligations, including any COBRA-related obligations, that are or become due to any current or former employee, director or independent contractor of Spring Bank or any of its subsidiaries before or after the Closing; |
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any outstanding lease obligations, as calculated in accordance with the Exchange Agreement; |
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any payments to be made by Spring Bank or any of its subsidiaries in connection with the termination of any existing contract and to wind down all clinical trial programs of Spring Bank or any of its subsidiaries, other than Spring Banks ongoing Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation, and cohort expansion study examining SB 11285 administered as an IV infusion in patients with advanced solid tumors, referred to herein as the STING trial; and |
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all accrued and unpaid taxes of Spring Bank and its subsidiaries. |
C. Plus or Minus:
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the net amount of any transaction expense reimbursement owed to, or transaction expense payment owed by Spring Bank pursuant to the Exchange Agreement. |
Spring Banks net cash will not be reduced by any of the following:
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certain reimbursable costs or expenses of Spring Bank in connection with the performance of Spring Banks obligation related the Approved Development Transaction (as defined below); |
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any payments to holders of any Spring Banks 2016 warrants that elect to receive the Black-Scholes value of such warrants pursuant to their terms; |
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any costs or expenses, including attorneys fees or settlement costs, incurred in connection with any potential or actual security holder litigation arising or resulting from the Exchange including all amounts paid or payable up to the retention amount of any insurance policy that covers or may cover such costs or expenses and amounts not covered by any such insurance policy; |
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any costs or expenses of Spring Bank in connection with Spring Banks completion of the STING Trial; or |
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any costs or expenses, including attorneys fees or settlement costs, incurred in connection with any exercise of appraisal rights by Spring Bank stockholders in connection with the Exchange. |
In no event may Spring Banks net cash exceed an amount equal to the sum of (i) $17,840,000 plus (ii) the excess, if any, of the amount of gross proceeds from the Pre-Closing Financing in excess of $14.5 million. In the event that Spring Banks net cash would exceed the limit described above, Spring Bank is required to pay the amount of such excess as a cash dividend to the holders of Spring Bank common stock immediately prior to the Closing.
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Illustrative Examples of Exchange Ratio Calculations
For illustrative purposes only, the examples presented below calculate the Exchange Ratio under various Spring Bank net cash and Pre-Closing Financing scenarios. These examples have assumed: (i) the Closing occurs on , 2020, (ii) Spring Bank outstanding shares (which includes issued and outstanding shares of Spring Bank common stock and shares of Spring Bank common stock subject to stock awards, each as of , 2020) and (iii) F-star outstanding shares. For the purposes of this illustration, it is assumed that no Spring Bank options will be net exercised for shares of Spring Bank common stock. The table below also does not reflect the effectiveness of the Reverse Stock Split.
Pre-Closing Financing Gross Proceeds |
Spring
Bank Net Cash |
Exchange
Ratio |
Post-Exchange
Ownership by Spring Bank Securityholders |
Post-Exchange
Ownership of F-star Securityholders |
||||||||||||
$ | % | % | ||||||||||||||
$ | % | % | ||||||||||||||
$ | % | % |
No fractional shares of Spring Bank common stock will be issuable pursuant to the Exchange. Instead, each ordinary share of F-star will be sold to Spring Bank in exchange for a number of shares of Spring Bank common stock, based on the Exchange Ratio, rounded down to the nearest whole share of Spring Bank common stock after aggregating all fractional shares issuable to each Seller on a holder by holder basis.
The Exchange Agreement does not include a stock price-based termination right, and there will be no adjustment to the total number of shares of Spring Bank common stock that the holders of F-star share capital will be entitled to receive at Closing for changes in the market price of Spring Bank common stock. Accordingly, the market value of the shares of Spring Bank common stock issued pursuant to the Exchange will depend on the market value of the shares of Spring Bank common stock at Closing, and could vary significantly from the market value of Spring Bank common stock on the date of this proxy statement/prospectus. Further, these example Exchange Ratios will vary depending on the amount of Spring Bank net cash at Closing, the timing of Closing, the actual ratio of the Reverse Stock Split, amounts raised in the Pre-Closing Financing and the terms thereof, and as further set forth in the Exchange Agreement.
Procedures for Exchanging F-star Share Certificates
The Exchange Agreement provides that, on or prior to the Closing, Spring Bank will deposit with Spring Banks exchange agent stock certificates or uncertificated book entries representing the shares of Spring Bank common stock issuable to the holders of F-star shares in the Exchange. Upon surrender of a duly executed stock transfer form in favor of Spring Bank and the F-star share certificate(s) in respect of the F-star shares to which such stock transfer form relates (or an indemnity for lost certificates) for exchange to Spring Banks exchange agent, together with such other documents as the exchange agent or Spring Bank may reasonably require, the F-star share certificate surrendered will be cancelled and the holder of the F-star share certificate(s) will be entitled to receive a certificate (or book entry) representing the number of whole shares of Spring Bank common stock that such holder has the right to receive pursuant to the provisions of the Exchange Agreement.
Closing of the Exchange
The Exchange Agreement requires the parties to consummate the Exchange as promptly as practicable (and in any event within two business days) after all of the conditions to the consummation of the Exchange contained in the Exchange Agreement are satisfied or waived, including the approval by the Spring Bank stockholders of the issuance of Spring Bank common stock, the amendment to the certificate of incorporation of Spring Bank effecting the Reverse Stock Split, the amendment to the certificate of incorporation of Spring Bank effecting the Spring Bank Name Change and the other transactions proposed under the Exchange Agreement, other than those conditions that by their nature are to be satisfied at the Closing. Neither Spring Bank nor F-star can predict the exact timing of the consummation of the Exchange.
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Regulatory Approvals
In the United States, Spring Bank must comply with applicable federal and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Spring Bank common stock and the filing of this proxy statement/prospectus with the SEC.
Material U.S. Federal Income Tax Consequences of the Exchange To U.S. Holders
The following is a general summary of the material U.S. federal income tax consequences of the Exchange to U.S. Holders (as defined below) of F-star and Spring Bank. This discussion does not purport to be a complete analysis of all potential tax consequences of the Exchange. This discussion is based upon the Internal Revenue Code of 1986, as amended (the Code), Treasury regulations, judicial authorities, published positions of the Internal Revenue Service (the IRS) and other applicable authorities, all as currently in effect and all of which are subject to change or differing interpretations (possibly with retroactive effect). Any such change or differing interpretation could affect the continuing validity of this discussion. Neither F-star nor Spring Bank has sought or intend to seek any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a position regarding the U.S. federal income tax consequences of the Exchange contrary to those discussed below.
This discussion is limited to U.S. Holders that hold their shares of F-star or Spring Bank as capital assets within the meaning of Section 1221 of the Code. This discussion does not address all of the tax consequences that may be applicable to a particular F-star or Spring Bank stockholder or to F-star or Spring Bank stockholders that are subject to special treatment under U.S. federal income tax laws, such as:
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shareholders that are not U.S. Holders; |
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financial institutions; |
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investors in pass-through entities, including (but not limited to) partnerships or limited liability companies treated as partnerships for tax purposes; |
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insurance companies; |
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tax-exempt organizations; |
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pension plans; |
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controlled foreign corporations; |
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passive foreign investment companies; |
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corporations that accumulate earnings to avoid U.S. federal income tax; |
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regulated investment companies or real estate investment trusts; |
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brokers or dealers in securities or currencies; |
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certain expatriates or persons whose functional currency is not the U.S. dollar; |
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traders in securities that elect to use a mark to market method of accounting; |
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persons that hold Spring Bank common stock or F-star shares as part of a straddle, hedge, constructive sale, synthetic security or other integrated investment, or conversion transaction; |
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persons that received Spring Bank common stock or F-star shares upon the conversion of a convertible note or any other convertible instrument; |
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persons who own 10% or more of the voting power of F-star and who are considered United States Shareholders of a controlled foreign corporation with respect to F-star; and |
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U.S. Holders that acquired their shares of Spring Bank common stock or F-star shares through the exercise of an employee stock option or otherwise as compensation. |
In addition, this discussion does not address any alternative minimum tax or any state, local or foreign tax consequences of the Exchange, nor does it address any tax consequences arising under the unearned income Medicare contribution tax pursuant to the Health Care and Education Reconciliation Act of 2010.
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If a partnership or other entity taxed as a partnership holds F-star shares or Spring Bank common stock, the tax treatment of a partner in the partnership generally will depend upon the status of the partner, the activities of the partnership and certain determinations made at the partner level. Partnerships and partners in such a partnership should consult their tax advisors about the tax consequences of the Exchange to them.
For purposes of this discussion, the term U.S. Holder means a beneficial owner of F-star shares or Spring Bank common stock that for U.S. federal income tax purposes is:
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a citizen or resident of the United States; |
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a corporation, or other entity treated as a corporation, created or organized in or under the laws of the United States or any state or political subdivision thereof; |
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an estate that is subject to U.S. federal income tax on its income regardless of its source; or |
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a trust, the substantial decisions of which are controlled by one or more U.S. persons and which is subject to the primary supervision of a U.S. court, or a trust that validly has elected under applicable Treasury regulations to be treated as a U.S. person for U.S. federal income tax purposes. |
YOU SHOULD CONSULT YOUR OWN TAX ADVISOR WITH RESPECT TO THE U.S. FEDERAL, STATE AND LOCAL AND NON-U.S. TAX CONSEQUENCES OF THE EXCHANGE. THIS SUMMARY IS NOT INTENDED TO BE, NOR SHOULD IT BE CONSTRUED TO BE, LEGAL OR TAX ADVICE TO ANY PARTICULAR SHAREHOLDER.
U.S. Federal Income Tax Treatment of the Exchange
Spring Bank and F-star intend to treat the Exchange as constituting a reorganization within the meaning of Section 368(a)(1)(B) of the Code (a B-Reorganization). However, it is uncertain whether the Exchange constitutes a B-Reorganization.
In order for the Exchange to qualify as a B-Reorganization, several conditions must be satisfied, including that Spring Bank (or a corporation controlled by Spring Bank, within the meaning of Section 368(c) of the Code) must acquire, solely in exchange for voting stock of Spring Bank, shares of F-star so that immediately after such exchange the acquiring corporation has control of F-star (within the meaning of Section 368(c) of the Code). In this regard, the United States Supreme Court has held that the solely for voting stock test is to be strictly construed and the test does not permit any consideration other than voting stock to be paid by the acquiring corporation.
In connection with the Exchange, holders of certain F-star share options and warrants that were issued to employees and others performing services for F-star, or F-star stock-based awards, will receive an offer to exchange their F-star stock-based awards for options exercisable for Spring Bank common stock, or substituted Spring Bank options. In the context of a reorganization, a substitution of compensatory stock options is generally not considered in determining whether the acquiring corporation obtains control of the acquired corporation solely for voting stock if the substituted stock options have the same terms as the relinquished options and no additional benefits inure to the option holders upon substitution of the options.
Relying on a United States Supreme Court decision in Commissioner v. Court Holding Company, 324 U.S. 331 (1945), which held that the substance of a transaction and not its form will determine the federal income tax consequences of the transaction, the IRS held in Revenue Ruling 82-150 that, in certain situations, stock options should be treated as stock if the option holder has assumed the risks of an investor in equity. If the per share strike price at which a compensatory stock option is granted is set far enough below the fair market value per share of the underlying stock at the time the option is granted, the option holder may be considered to have acquired an interest in the equity of the option issuer and to therefore be exposed to the risks of an investor in equity. It is not clear, however, at what point the strike price of a stock option will be treated as sufficiently low such that the grantee will be treated as exposed to the risks of an investor in equity and the stock option will be treated as stock. If the F-star stock-based awards are treated as stock, they must be acquired solely for voting stock of Spring Bank for the Exchange to constitute a B-Reorganization.
If the F-star stock-based awards are treated as stock and must be acquired solely for voting stock of Spring Bank, there is a question as to whether the substituted Spring Bank options would also be treated as stock
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and a further question as to whether the substituted Spring Bank options would be treated as voting stock. In Revenue Ruling 71-83, the IRS determined that stock that does not presently have voting rights but is convertible into stock with voting rights is not voting stock. The fact that the holders of the substituted Spring Bank options would acquire voting rights only upon their exercise may cause the stock to be nonvoting under the principles of Revenue Ruling 71-83. On the other hand, if the substituted Spring Bank options are treated as stock, the conversion may be deemed to have occurred such that the stock should be treated as voting stock.
On July 14, 2020, F-star issued stock option and restricted stock awards to its personnel utilizing for these purposes a strike price based on an appraisal of the fair market value its shares prepared by a qualified independent third-party valuation firm dated as of June 15, 2020. At the date on which such F-star stock-based awards were made, discussions between F-star and Spring Bank were ongoing, but the ultimate outcome of the discussions, including whether the Exchange Agreement would be negotiated to completion and entered into, remained uncertain. F-star obtained a confirmation from the qualified independent third-party valuation firm that the June 15, 2020 issued valuation still properly reflects the fair market value of its shares that underlie the July stock-based awards.
Because of the circumstances surrounding the issuance of certain F-star stock-based awards and timing of the underlying valuation used in connection thereof as well as lack of sufficient authoritative guidance in the Code and Treasury Regulations and from the IRS and courts as to the circumstances in which the F-star stock-based awards would be treated as stock and the Spring Bank substituted options would be treated as voting stock, it is uncertain whether the solely for voting stock test is met in the Exchange and, as a result, whether control of F-star is acquired in exchange solely for Spring Bank voting stock in the Exchange. Consequently, whether the Exchange constitutes a B-Reorganization is uncertain.
Material U.S. Federal Income Tax Consequences of the Exchange to U.S. Holders of F-star
If the Exchange constitutes a B-Reorganization, subject to the passive foreign investment company (PFIC) discussion below, the following federal income tax treatment would apply to a U.S. Holder of F-star shares who exchanges F-star shares for Spring Bank stock in the Exchange:
(i) |
no gain or loss would be recognized upon the U.S. Holders receipt of Spring Bank common stock in exchange for the U.S. Holders ordinary shares of F-star; |
(ii) |
the U.S. Holders tax basis of the shares of Spring Bank common stock received would be the same as the tax basis of the U.S. Holders ordinary shares of F-star exchanged therefor; and |
(iii) |
the holding period of the Spring Bank common stock in the hands of the U.S. Holder would include the holding period of the U.S. Holders ordinary shares of F-star exchanged therefor. |
If, however, the Exchange does not constitute a B-Reorganization, the following federal income tax treatment would apply for a U.S. Holder of F-star shares:
(i) |
the U.S. Holder would recognize gain or loss equal to the difference, if any, between the fair market value (as of the closing of the Exchange) of the shares of Spring Bank common stock received pursuant to the Exchange and the U.S. Holders tax basis in the ordinary shares of F-star surrendered in exchange therefor; |
(ii) |
the tax basis of the shares of Spring Bank common stock received by the F-star shareholders would be the fair market value (as of the closing of the Exchange) of such shares; and |
(iii) |
the holding period of the Spring Bank common stock in the hands of the F-star shareholders would commence on the day following the closing date of the Exchange. |
Any gain or loss recognized would be capital gain or loss if the ordinary shares of F-star were a capital asset in the hands of the shareholder and would be long-term capital gain or loss if held by such shareholder for more than one year. In general, the federal income tax rates applicable to long-term capital gains and ordinary income (including short-term capital gains) of taxpayers that are individuals may differ, while for corporations capital gains and ordinary income are generally taxed at the same rate. The deductibility of capital losses is subject to limitations.
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Passive Foreign Investment Company Rules
A corporation will generally be treated as a PFIC for U.S. federal income tax purpose for any taxable year in which, after taking into account the income and assets of such Corporation and any subsidiaries which are at least 25% owned, either (i) at least 75% of its gross income consists of certain types of passive income (such as dividends, interest, rents, royalties and the excess of gains over losses from the disposition of assets which produce passive income) or (ii) at least 50% of the average quarterly value of its assets consists of assets that produce, or are held to produce, passive income. For purposes of this determination, rents and gains from real estate may be considered active income, and the real estate may be considered an active asset, where the lessor regularly performs active and substantial management and operational functions through its own officers and employees, and certain additional requirements are met. F-star believes that it is not currently a PFIC and was not a PFIC in prior years, however, the determination of whether F-star is or was a PFIC is uncertain as it depends on the particular facts and circumstances (such as the valuation of F-stars assets, including goodwill and other intangible assets) and may also be affected by the application of the PFIC rules, which are subject to differing interpretations. Accordingly, no assurance can be provided as to the current or prior treatment of F-star as a PFIC. If F-star is currently a PFIC, or was treated as a PFIC during the period in which a U.S. Holder held F-star shares, special rules may apply. U.S. Holders of F-star shares should consult their tax advisors regarding the potential U.S. federal income tax consequences of the Exchange to them if F-star is or was treated as a PFIC.
Material U.S. Federal Income Tax Consequences of the Exchange to U.S. Holders of Spring Bank
There are no material U.S. federal income tax consequences of the Exchange to U.S. Holders of Spring Bank common stock.
Material U.K. Income Tax Consequences of the Exchange
The summary set out below is based on current United Kingdom (UK) tax law and HM Revenue and Customs (HMRC) practice (which may not be binding on HMRC) as of the date of this proxy statement/prospectus, both of which are subject to change, possibly with retrospective effect.
This information should apply only to shareholders resident and, in the case of an individual, domiciled for tax purposes in the UK, who currently are the beneficial owners of F-star shares as an investment and for whom the F-star shares constitutes employment related securities.
This summary is for general information only and is not intended to be, nor should it be considered to be, legal or tax advice to any particular investor. It does not address all of the tax considerations that may be relevant to specific investors in light of their particular circumstances or to investors subject to special treatment under UK tax law. Each holder of F-star share capital should consult with their tax advisor for a full understanding of the tax consequences of the Exchange to that stockholder.
Spring Bank and F-star intend the Exchange to qualify as a UK tax free reorganization. Subject to certain conditions, the Capital Gains Tax (CGT) legislation in Section 135 TCGA 1992 provides that F-star shares exchanged for Spring Bank Shares may be treated for UK tax residents as a reorganization of the original holding such that the Spring Bank Shares may be treated as if they were the original F-star stockholding and there should be no disposal for CGT purposes as a result of such reorganization.
The conditions of Section 135 TCGA 1992 are:
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Spring Bank will hold more than 25% of the original share capital of F-star; and |
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The exchange of securities takes place for bona fide commercial reasons and does not form part of a scheme or arrangements, of which the main purpose, or one of the main purposes is the avoidance of liability to CGT (Section 137 TCGA 1992). |
Advance clearance from HMRC under Section 138 TCGA 1992 that the bona fide commercial reasons test applies has been received. It should be noted that this test should only be relevant in the case of stockholders who (together with persons connected with them) currently hold more than 5% of F-star shares.
Advance clearance has also been obtained from HMRC under Section 701 ITA 2007 and Section 748 CTA 2010 that the main purpose, or one of the main purposes, of the Exchange is not to obtain an income tax or
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corporation tax advantage for UK individual or corporate stockholders, so that the transactions in securities rules should not apply to recharacterize the Exchange into a taxable event from the perspective of such individuals or corporates.
In the event that the conditions of Section 135 TCGA 1992 are not met, the Exchange is a chargeable event under the provisions of the CGT legislation. Each UK stockholder of F-star share capital will generally recognize a chargeable gain or loss on the receipt of shares of Spring Bank common stock issued to such holder of F-star share capital.
Information Reporting Requirements
If the Exchange constitutes a B-Reorganization, certain U.S. Holders that receive Spring Bank common stock in the Exchange will be required to file statements with their U.S. federal income tax returns setting forth their basis in the F-star shares surrendered and the fair market value of the consideration received in the Exchange, and to retain permanent records of the facts relating to the Exchange. U.S. Holders are urged to consult their tax advisors to comply with these rules.
THE DISCUSSION SET FORTH ABOVE IS BASED ON CURRENTLY EXISTING PROVISIONS OF THE CODE, EXISTING AND PROPOSED TREASURY REGULATIONS THEREUNDER AND CURRENT ADMINISTRATIVE RULINGS AND COURT DECISIONS.
ALL OF THE FOREGOING ARE SUBJECT TO CHANGE AND ANY SUCH CHANGE COULD AFFECT THE CONTINUING VALIDITY OF THIS DISCUSSION. EACH F-STAR SHAREHOLDER AND SPRING BANK STOCKHOLDER SHOULD DIRECTLY CONSULT AN INDEPENDENT TAX ADVISOR WITH RESPECT TO THE SPECIFIC TAX CONSEQUENCES OF THE TRANSACTION TO HIM, HER, OR IT INCLUDING THE APPLICATION AND EFFECT OF STATE, LOCAL AND FOREIGN TAX LAWS.
Nasdaq Capital Market Listing
Spring Bank common stock is currently listed on the Nasdaq Capital Market under the symbol SBPH. Spring Bank has agreed to use commercially reasonable efforts to maintain its existing listing on the Nasdaq Capital Market, and to obtain approval for listing on the Nasdaq Capital Market of the shares of Spring Bank common stock that holders of F-star share capital will be entitled to receive pursuant to the Exchange. In addition, under the Exchange Agreement, each partys obligation to complete the Exchange is subject to the satisfaction or waiver by each of the parties, at or prior to the Closing, of various conditions, including that shares of Spring Bank common stock to be issued in the Exchange to be approved for listing on the Nasdaq Capital Market as of the Closing.
Spring Bank intends to file an initial listing application with the Nasdaq Capital Market pursuant to Nasdaqs rules for companies conducting a business combination that results in a change of control. If this application is accepted, Spring Bank anticipates that its common stock will be listed on the Nasdaq Capital Market following the Closing under the trading symbol FSTX.
Anticipated Accounting Treatment
The Exchange will be recorded as a business combination using the acquisition method of accounting in accordance with Accounting Standards Codification Topic 805, Business Combinations. U.S. GAAP requires that one of the two companies in a merger be designated as the acquirer for accounting purposes based on evidence available. F-star will be treated as the acquiring entity for accounting purposes. In identifying F-star as the acquiring entity for accounting purposes, F-star and Spring Bank took into account factors such as, but not limited to, the anticipated voting rights of all equity instruments following the Exchange, the intended corporate governance structure of the combined company, composition of senior management, and the relative size of each of the companies. No single factor was the sole determinant in the overall conclusion that F-star has been designated as the acquirer for accounting purposes, rather all factors were considered in arriving at such conclusion.
Management of F-star and Spring Bank have determined a preliminary estimate of the purchase price calculated as described in Note 2 to the unaudited pro forma condensed combined financial statements. The net
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tangible assets acquired and liabilities assumed of Spring Bank in connection with the Exchange are recorded at their estimated acquisition date fair values. The acquisition method of accounting is dependent upon certain valuations and any other studies and calculations deemed necessary that have yet to commence or progress to a stage where there is sufficient information for a definitive measurement. A final determination of these estimated fair values, which cannot be made prior to the completion of the Exchange, will be based on the actual net tangible assets of Spring Bank that exist as of the date of completion of the Exchange.
Appraisal Rights and Dissenters Rights
Under the DGCL, the stockholders of Spring Bank do not have appraisal rights in connection with the issuance of shares of F-star common stock pursuant to the Exchange Agreement and the resulting change of control of F-star. F-star shareholders generally do not have appraisal rights under English law.
Strategic Advisory Fee
Pursuant to a February 14, 2020 engagement letter between F-star and a strategic advisor engaged to act as F-stars strategic advisor in connection with a potential transaction or transactions, if the Share Exchange is consummated, the strategic advisor will be entitled to receive a transaction fee of up to $1.0 million. Additionally, F-star has agreed to reimburse the strategic advisor for its out-of-pocket expenses up to a maximum of $100,000 in the aggregate. F-star has also agreed to indemnify the strategic advisor against certain liabilities, which are customary in transactions of this nature.
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The following is a summary of the material terms of the Exchange Agreement. A copy of the Exchange Agreement is attached as Annex A to this proxy statement/prospectus and is incorporated by reference into this proxy statement/prospectus. The Exchange Agreement has been attached to this proxy statement/prospectus to provide you with information regarding its terms. It is not intended to provide any other factual information about Spring Bank or F-star. The following description does not purport to be complete and is qualified in its entirety by reference to the Exchange Agreement. You should refer to the full text of the Exchange Agreement for details of the Exchange and the terms and conditions of the Exchange Agreement. Capitalized terms used but not otherwise defined will have the respective meanings ascribed to such terms in the Exchange Agreement.
The Exchange Agreement contains representations and warranties that Spring Bank, on the one hand, and F-star and the holders of F-star shares and notes convertible into F-star shares who are parties to the Exchange Agreement, on the other hand, have made to one another as of specific dates. These representations and warranties have been made for the benefit of the other parties to the Exchange Agreement and may be intended not as statements of fact but rather as a way of allocating the risk to one of the parties if those statements prove to be incorrect. In addition, the assertions embodied in the representations and warranties are qualified by information in confidential disclosure schedules exchanged by Spring Bank and F-star pursuant to the Exchange Agreement. While Spring Bank and F-star do not believe that these disclosure schedules contain information required to be publicly disclosed under the applicable securities laws, other than information that has already been so disclosed, the disclosure schedules do contain information that modifies, qualifies and creates exceptions to the representations and warranties set forth in the attached Exchange Agreement. Accordingly, you should not rely on the representations and warranties as current characterizations of factual information about any of the parties to the Exchange Agreement, because they were made as of specific dates, may be intended merely as a risk allocation mechanism among the parties and are modified by the disclosure schedules.
General
Under the Exchange Agreement, at the Closing, Spring Bank will acquire all of the issued and outstanding share capital of F-star (including all F-star ordinary shares issued upon the conversion of F-stars Seed Preference Shares and Series A Preference Shares of F-star, referred to herein as the F-star Share Conversion, and upon the conversion of all outstanding F-star convertible loan notes, referred to herein as the F-star Note Conversion), and, after giving effect to the Exchange, F-star will continue as a wholly-owned subsidiary of Spring Bank. Spring Bank and F-star intend to treat the Exchange as constituting a reorganization within the meaning of Section 368(a)(1)(B) of the Internal Revenue Code of 1986, as amended (a B-Reorganization). As further described in the section titled The ExchangeMaterial U.S. Federal Income Tax Consequences of the Exchange to U.S. Holders in this proxy statement/prospectus, whether the Exchange constitutes a B-Reorganization is uncertain. Please review the information in the above referenced section of this proxy statement/prospectus for a more complete description of the material U.S. federal income tax consequences of the Exchange.
Exchange Consideration and Potential Adjustment
See the sections titled The ExchangeExchange Consideration and Adjustment, The ExchangeThe Pre-Closing Financing and The ExchangeDetermination of Spring Banks Net Cash for a discussion relating to the consideration to be transferred in the Exchange under the Exchange Agreement and how any adjustments will be made at the Closing.
Treatment of Spring Bank Options and Restricted Stock Units
Prior to the Closing, the Spring Bank Board will take all actions necessary and appropriate to provide that all unvested issued and outstanding Spring Bank options will be accelerated and vested in full immediately prior to the Closing and, following this acceleration, each option that has not previously been exercised will expire on the date of the Closing.
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Prior to the Closing, the Spring Bank Board will take all actions necessary and appropriate to provide that all performance and other conditions to the lapsing of restrictions on each outstanding Spring Bank restricted stock unit, whether vested or unvested, will be deemed to be satisfied as of immediately prior to the Closing.
Treatment of F-star Options and F-star Restricted Stock Units
Prior to (and conditional upon and effective as of) the Closing, the Spring Bank Board will assume the F-star EIP. Immediately after the Closing, each holder of outstanding Original EIP Options will be granted, in exchange for the holders Original EIP Option, a Replacement EIP Option, which will be an option to subscribe for or purchase shares of Spring Bank common stock. The vesting schedule applicable to each Replacement EIP Option will be the same as the vesting schedule applicable to the Original EIP Option that it replaces. The number of shares of Spring Bank common stock issuable on exercise in full of each Replacement EIP Option will be calculated by applying the Exchange Ratio to the number of F-star ordinary shares issuable on exercise in full of the Original EIP Option that it replaces, and rounding the resulting number down to the nearest whole number of shares of Spring Bank common stock. The aggregate exercise price payable to exercise in full of each Replacement EIP Option will be the same as the aggregate exercise price payable to exercise in full of the Original EIP Option that it replaces; provided, however, that the exercise price with respect to a Replacement EIP Option may be adjusted, as required by the Exchange Agreement, with respect to any option granted to a United States participant under the F-star EIP.
Each holder of outstanding Original EIP RSUs will, immediately after the Closing and in exchange for the holders Original EIP RSU, be granted a Replacement EIP RSU. Each Replacement EIP RSU will be granted under the Assumed Plan and will be a right to acquire shares of Spring Bank common stock. The number of shares of Spring Bank common stock issuable on vesting in full of each Replacement EIP RSU will be calculated by applying the Exchange Ratio to the number of F-star ordinary shares issuable on vesting in full of the Original EIP RSU that it replaces, and rounding the resulting number down to the nearest whole number of shares of Spring Bank common stock.
The Replacement EIP RSUs and Replacement EIP Options will be subject to the same terms and conditions as the Original EIP RSUs and Original EIP Options, respectively (except to the extent such terms are rendered inoperative as a result of the transactions contemplated by the Exchange Agreement), and will not provide holders of the Replacement EIP Options or Replacement EIP RSUs with any additional benefits that the holders did not have under their Original EIP Options or Original EIP RSUs. Similarly, the grant of Replacement EIP Options in exchange for the release of Original EIP Options shall be effected in such manner as shall meet the requirements of Part 6 of Schedule 5 to ITEPA 2003 so as to ensure that each Replacement EIP Option shall qualify as Replacement Options under the said Part 6 of Schedule 5 to ITEPA 2003.
Pursuant to the terms of the F-star EIP, the holders of Original EIP Options will be offered the choice to exchange their options for Replacement EIP Options, and the holders of Original EIP RSUs will be offered the choice to exchange their RSUs for Replacement EIP RSUs. If any holder of Original EIP Options that is an EMI Option, as defined in the F-star EIP, does not accept the exchange offer, the portion of their Original EIP Options that are unvested as of the Closing will immediately lapse in accordance with the rules of the F-star EIP. If any holder of an Original EIP RSU does not accept the exchange offer, upon the vesting of such RSU, F-star will immediately exercise its right to purchase the issued F-star ordinary shares in accordance with the articles of association of F-star.
Prior to the Closing, each holder of F-star Legacy Options will be notified by the F-star Board of Directors that they may exercise their F-star Legacy Options conditional upon and effective at the Closing. If a holder of F-star Legacy Option fails to exercise such options, any unexercised F-star Legacy Options will cease to be exercisable effective upon the Closing and will terminate six months following the Closing. If a holder of any F-star Legacy Options fails to accept the offer to exercise its F-star Legacy Option, upon the exercise of such F-star Legacy Option, F-star will immediately exercise its right to purchase the F-star ordinary shares issued upon such exercise in accordance with the articles of association of F-star.
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Directors and Officers of Spring Bank Following the Exchange
Pursuant to the Exchange Agreement, all of the directors of Spring Bank, other than David Arkowitz, Todd Brady, M.D., Ph.D. and Pamela Klein, M.D., will resign immediately prior to the Closing. David Arkowitz, Todd Brady, M.D., Ph.D. and Pamela Klein, M.D. will then elect, effective as of immediately following the Closing, five designees selected by F-star, namely Nessan Bermingham, Ph.D., who will be the Chairman, and Eliot Forster, Ph.D., Edward Benz, M.D., Geoffrey Race and Patrick Krol. It is anticipated or will be that the executive officers of Spring Bank upon the Closing will be Eliot Forster, Ph.D., Chief Executive Officer, Darlene Deptula-Hicks, Chief Financial Officer, Neil Brewis, Ph.D., Chief Scientific Officer, and Louis Kayitalire, M.D., Chief Medical Officer.
Amendments to the Amended and Restated Certificate of Incorporation of Spring Bank
In addition to the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and the resulting change of control, stockholders of record of Spring Bank common stock on the record date for the Special Meeting will be asked to approve and adopt amendments to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split and the Spring Bank Name Change. The matters to be acted on by Spring Bank stockholders are collectively referred to herein as the Company Stockholder Approval Matters.
Conditions to the Completion of the Exchange
Each partys obligation to complete the Exchange is subject to the satisfaction (or waiver) at or prior to the Closing of various conditions, which include the following:
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no temporary restraining order, preliminary or permanent injunction or other order preventing the Closing shall have been issued by ant court of competent jurisdiction and remain in effect and no statute, rule, regulation or order shall be enacted, entered, enforced or deemed applicable to the Exchange, which makes the consummation of the Exchange illegal; |
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the stockholders of Spring Bank must have approved the Company Stockholder Approval Matters; |
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the registration statement of which this proxy statement/prospectus forms a part must be effective and no stop order suspending the effectiveness of the registration statement shall have been issued and no proceedings for such purpose shall have been initiated by the SEC; |
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prior to the conclusion of the Special Meeting, the SEC shall not have issued an order suspending the use of this proxy statement/prospectus, and no proceeding in respect of the proxy statement/prospectus shall have been initiated by the SEC; |
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the shares of Spring Bank common stock to be issued in the Exchange to be approved for listing on Nasdaq, subject to consummation of the Exchange and official notice of issuance; and |
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all foreign antitrust approvals, to the extent applicable, shall have been obtained. |
In addition, the obligation of F-star and the F-star shareholders to complete the Exchange is further subject to the satisfaction of the following conditions:
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the representations and warranties of Spring Bank with respect to organization and qualification and charter documents, capital structure, and authority, non-contravention and approvals (other than, with respect to capital structure, inaccuracies that are de minimis, individually or in the aggregate), must be true and correct on the date of the Exchange Agreement and on the date of the Closing in all respects as if made on date of the Closing date or, if such representations and warranties address matters as of a particular date, then as of that particular date; |
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all other representations and warranties of Spring Bank, must be true and correct on the date of the Exchange Agreement and on the date of Closing date in all respects as if made on the date of Closing or, if such representations and warranties address matters as of a particular date, then as of that particular date, except where the failure of these representations and warranties to be true and correct (disregarding all qualifications or limitations as to materiality, Spring Bank Material Adverse Effect and words of similar import) has not had, individually or in the aggregate, a Spring Bank |
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Material Adverse Effect, as described in the section Exchange AgreementRepresentations and Warranties; |
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Spring Bank must have performed or complied with in all material respects all agreements and covenants in the Exchange Agreement required to be performed or complied with by it on or prior to the Closing; |
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Since the date of the Exchange Agreement, no Spring Bank Material Adverse Effect shall have occurred and be continuing, as described in the section Exchange AgreementRepresentations and Warranties; |
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Spring Bank must have delivered certain certificates and other documents required under the Exchange Agreement for the Closing; |
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Spring Bank must have delivered to F-star written resignations of the officers and directors of Spring Bank that are not continuing as officers and directors of the combined company following the Exchange and must have caused the board of directors of the combined company to be constituted as agreed to by Spring Bank and F-star effective as of the Closing; |
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F-star must have received lock-up agreements from each director and executive officer of Spring Bank, each of whom has already executed and delivered such agreements to F-star, and such lock-up agreements must be in full force and effect; |
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no delisting or suspension in trading of Spring Bank common stock on Nasdaq shall be in effect as of the Closing; |
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Certain contracts of Spring Bank must have been terminated, or, to the extent such contracts have not been terminated as of the Closing, notice of termination shall have been given under such contracts (with any monetary liabilities resulting from such termination being accounted for in the calculation of Spring Banks net cash); and |
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the Reverse Stock Split must have been effected. |
In addition, the obligation of Spring Bank to complete the Exchange is further subject to the satisfaction of the following conditions:
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the representations and warranties of F-star with respect to organization and qualification and charter documents, capital structure, authority, non-contravention and approvals, employee benefit plans and ownership of Spring Bank common stock (other than, with respect to capital structure, inaccuracies that are de minimis, individually or in the aggregate) must be true and correct on the date of the Exchange Agreement and on the date of Closing in all respects as if made on the date of Closing or, if such representations and warranties address matters as of a particular date, then as of that particular date; |
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the representations and warranties of the F-star shareholders with respect to the ownership of the F-star shares and F-star loan notes and authority and non-contravention (other than, with respect to ownership, inaccuracies that are de minimis, individually or in the aggregate) must be true and correct on the date of the Exchange Agreement and on the date of Closing in all respects as if made on the date of Closing or, if such representations and warranties address matters as of a particular date, then as of that particular date; |
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all other representations and warranties of F-star and the F-star shareholders must be true and correct on the date of the Exchange Agreement and on the date of Closing date in all respects as if made on the date of Closing or, if such representations and warranties address matters as of a particular date, then as of that particular date, except where the failure of these representations and warranties to be true and correct (disregarding all qualifications or limitations as to materiality, F-star Material Adverse Effect and words of similar import) has not had, individually or in the aggregate, an F-star Material Adverse Effect, as described in the section Exchange AgreementRepresentations and Warranties; |
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F-star and the F-star shareholders must have performed or complied with in all material respects all agreements and covenants in the Exchange Agreement required to be performed or complied with by them on or prior to the Closing; |
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the Pre-Closing Financing must have occurred in accordance with the terms of the equity commitment letters and subscription agreements entered into in connection therewith; |
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since the date of the Exchange Agreement, no F-star Material Adverse Effect shall have occurred and be continuing, as described in the section Exchange AgreementRepresentations and Warranties; |
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F-star must have delivered certain certificates and other documents required under the Exchange Agreement for the Closing; |
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the F-star shareholders must have delivered to the Exchange Agent share certificates representing all of the issued F-star ordinary shares, together with appropriate transfer documents effecting the transfer of all of the F-star ordinary shares to Spring Bank; |
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F-star must have executed and delivered an allocation certificate to Spring Bank; |
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the Conversions must have occurred; and |
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Spring Bank must have received lock-up agreements from each director and executive officer of F-star, and each F-star shareholder affiliated with a director or executive officer of F-star, each of whom has already executed and delivered such agreements to Spring Bank, and such lock-up agreements, together with other lock-up agreements obtained after the date of the Exchange Agreement and received by Spring Bank must be in full force and effect. |
Representations and Warranties
The Exchange Agreement contains customary representations and warranties for a transaction of this type relating to, among other things, with respect to:
F-star and Spring Bank:
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corporate organization and qualification and similar corporate matters; |
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capitalization |
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authority to enter into the Exchange Agreement and related agreements, enforceability; |
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noncontravention with organizational documents and legal requirements; |
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required third-party consents, approvals, notices and filings; |
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financial statements; |
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liabilities; |
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material changes or events; |
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tax matters; |
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intellectual property; |
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compliance with legal and regulatory requirements; |
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legal proceedings and orders; |
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brokers, finders or other fees or commissions in connection with the Exchange; |
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employee and labor matters and benefit plans; |
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title to assets, real property and leaseholds; |
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environmental matters; |
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material contracts and the validity and absence of breach of such contracts; |
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books and records; |
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insurance; |
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government contracts; |
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transactions with certain related parties; and |
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the inapplicability of state takeover statutes and Section 203 of the DGCL. |
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Spring Bank:
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the documents filed with the SEC and the accuracy of information contained in those documents; |
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Spring Banks code of ethics; |
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the opinion of Spring Banks financial advisor, Ladenburg; |
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shell company status; and |
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bank accounts and accounts receivable. |
F-star:
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ownership of Spring Bank capital stock; and |
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Pre-Closing Financing. |
Holders of F-star shares or convertible loan notes:
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ownership of F-star shares and convertible loan notes; |
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authority to enter into the Exchange Agreement and related agreements, enforceability; |
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tax matters; |
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accuracy of certain information; and |
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ownership of Spring Bank capital stock. |
The representations and warranties are, in many respects, qualified by materiality and knowledge and other similar qualifications. The representations and warranties of the parties to the Exchange Agreement will not survive the Closing, but their accuracy forms the basis of one of the conditions to the obligations of Spring Bank and F-star to complete the Closing. The representations and warranties have been made for the benefit of the other parties to the Exchange Agreement and may be intended not as statements of fact but rather as a way of allocating risk among the parties if a representation or warranty proves not to be true. In addition, the assertions embodied in the representations and warranties are qualified by information in confidential disclosure schedules exchanged by Spring Bank and F-star in connection with signing the Exchange Agreement. Also, the representations and warranties are subject to the materiality standard described in the Exchange Agreement, which may differ from what may customarily be viewed as material, cannot be the basis for any claims under the Exchange Agreement after termination of the Exchange Agreement and were made only as of the date of the Exchange Agreement or other date specified in the Exchange Agreement.
As noted above, significant portions of the representations and warranties are qualified as to materiality or material adverse effect. Under the Exchange Agreement, a Material Adverse Effect means an event, development, circumstance, change, effect or occurrence, that, considered together with all other events, developments, circumstances, changes, effects and occurrences, has, or, with respect to Spring Bank, is reasonably expected to have, a material adverse effect on (a) the ability of Spring Bank, F-star or the holders of shares or convertible loan notes of F-star to consummate the Exchange or perform their respective covenants or obligations under the Exchange Agreement or (b) the business, financial condition, operations or results of operations of Spring Bank or F-star, as applicable, and their respective subsidiaries, taken as a whole, except that none of the following, as they apply to Spring Bank, F-star and their respective subsidiaries, shall be taken into account in determining whether there has been a Material Adverse Effect:
Spring Bank and F-star
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conditions generally affecting the industries in which F-star or Spring Bank participates or the United States or global economy or capital markets as a whole, to the extent they do not have a disproportionate impact on F-star or Spring Bank or any of their respective subsidiaries, taken as a whole, relative to other companies in the industry in which they operate; |
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any failure by F-star or Spring Bank or their respective subsidiaries to meet its estimates or expectations of its development programs, internal or analyst (in the case of Spring Bank) projections |
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or forecasts or third party revenue or earnings predictions (but any event, development, circumstance, change, effect or occurrence causing or contributing to such failures may constitute a Material Adverse Effect and may be taken into account in determining whether a Material Adverse Effect has occurred). |
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the execution, delivery, announcement or performance of the obligations under the Exchange Agreement or the announcement, pendency or anticipated Closing; |
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natural disasters or acts of terrorism, sabotage, military action or war or any escalation or worsening thereof, or any viruses, pandemics, epidemic or other outbreak of illness or public health event, or any spread or worsening thereof, or any other event, development, circumstance, change, effect or occurrence that may be considered a force majeure event; or |
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changes in U.S. GAAP or International Financial Reporting Standards (IFRS) (with respect to F-star) or applicable legal requirements (or, in each case, the interpretation thereof) to the extent they do not disproportionately impact F-star or Spring Bank or any of their respective subsidiaries, taken as a whole, relative to other companies in the industry in which they operate; |
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the taking of any action, or the failure to take any action by F-star or Spring Bank or their respective subsidiaries, that is required or reasonably necessary to comply with the terms of the Exchange Agreement or the taking of any action permitted by the Exchange Agreement; |
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changes in or affecting research and development, clinical trials or other drug development activities (including the failure to obtain positive results from clinical trials, the occurrence of adverse events or serious adverse events in any clinical trial, development activities or favorable responses from any applicable governmental body) conducted by or on behalf of F-star or Spring Bank or their respective subsidiaries or licensees in respect of F-stars or Spring Banks products or product candidates (but any effect of any such adverse event or serious adverse event in any clinical trial (taking into account the intended patient population and phase of dose escalation of such clinical trial) on F-star or Spring Bank, as applicable, may be taken into account in determining whether a Material Adverse Effect has occurred); |
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any rejection or non-acceptance by a governmental body of a registration or filing by F-star or Spring Bank relating to any intellectual property rights of F-star or Spring Bank, as applicable; or |
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regulatory approval of, or regulatory action or announcement with respect to, any product, or product candidates, of a third party that are similar to, or expected to compete against, any of F-star or Spring Bank product candidates. |
Spring Bank
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changes in the trading price or trading volume of Spring Bank common stock (but any event, development, circumstance, change, effect or occurrence causing or contributing to such changes may constitute a Spring Bank Material Adverse Effect and may be taken into account in determining whether a Spring Bank Material Adverse Effect has occurred); |
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general conditions in financial markets and any changes therein (including any changes arising out of acts of terrorism, war, weather conditions or other force majeure event), to the extent that such conditions do not have a disproportionate impact on Spring Bank and its subsidiaries, taken as a whole, relative to other companies in the industry in which Spring Bank operates or to which other companies undertaking transactions similar to the transactions contemplated by the Exchange Agreement may be subject; or |
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any stockholder or derivative litigation arising from or relating to the Exchange Agreement or the transactions contemplated by the Exchange Agreement. |
No Solicitation
Both Spring Bank and F-star agreed that, except as described below, Spring Bank and F-star will not, nor will either party authorize or permit any of its subsidiaries or authorize the officers, directors, employees,
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partners, attorneys, advisors, accountants, agents or representatives of it or any of its subsidiaries to, directly or indirectly:
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solicit or initiate, or knowingly encourage, induce or facilitate the making, submission or announcement of, any Acquisition Proposal or F-star Acquisition Proposal, as applicable, or take any action that would reasonably be expected to lead to an Acquisition Proposal or F-star Acquisition Proposal, as applicable; |
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furnish any non-public information with respect to it or any of its subsidiaries to any person in connection with or in response to an Acquisition Proposal or F-star Acquisition Proposal, as applicable, or an inquiry or indication of interest that would reasonably be expected to lead to an Acquisition Proposal or F-star Acquisition Proposal, as applicable; |
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engage in discussions or negotiations with any person with respect to any Acquisition Proposal or F-star Acquisition Proposal, as applicable; |
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approve, endorse or recommend an Acquisition Proposal or F-star Acquisition Proposal, as applicable; or |
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enter into any letter of intent or similar document or any agreement providing for or otherwise relating to, with respect to Spring Bank, an Acquisition Transaction, or with respect to F-star, a transaction contemplated by an F-star Acquisition Proposal. |
The terms Acquisition Proposal is defined below under The Exchange AgreementSpring Bank Acquisition Proposal and Acquisition Transaction and the term F-star Acquisition Proposal is defined below under The Exchange AgreementF-star Acquisition Proposal.
However, before obtaining stockholder approval for the Company Stockholder Approval Matters, Spring Bank may furnish nonpublic information regarding Spring Bank and its subsidiaries to, and may enter into discussions with, any third party in response to an Acquisition Proposal that, after consultation with its outside legal and financial advisors, Spring Banks Board of Directors determines in good faith is, or is reasonably expected to result in, a Superior Offer (as defined below) if:
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neither Spring Bank nor any representative of Spring Bank has breached the non-solicitation provisions of the Exchange Agreement described above; |
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Spring Bank Board concludes in good faith, after consultation with its outside legal counsel, that the failure to take such action is reasonably likely to constitute a breach of the fiduciary duties of the board of directors to Spring Banks stockholders under applicable legal requirements; |
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prior to furnishing any such information to, or entering into discussions with such third party, Spring Bank gives F-star written notice of the identity of the third party and of Spring Banks intention to furnish information to, or enter into discussions with, such third party; |
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Spring Bank receives from the third party an executed confidentiality agreement on terms no more favorable to Spring Bank than the confidentiality agreement between Spring Bank and F-star and containing customary limitations on the use and disclosure of all nonpublic written and oral information furnished to such third party by or on behalf of Spring Bank; and |
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prior to or simultaneously with the furnishing of any such information to such third party, Spring Bank furnishes or makes available such nonpublic information to F-star, to the extent not previously furnished. |
A Superior Offer means a bona fide written Acquisition Proposal made by a third party for (i) any merger, consolidation, amalgamation, share exchange, business combination, issuance or acquisition of securities, tender offer, exchange offer or similar transaction in which Spring Bank is a constituent corporation, in which Spring Bank or its subsidiaries is a constituent corporation or in which any individual, entity, governmental entity, or group, as defined in the Exchange Act and the rules thereunder, directly or indirectly acquires beneficial or record ownership of securities representing more than 50% of the outstanding securities of any class of voting securities of Spring Bank or its subsidiaries, or in which Spring Bank or its subsidiaries issues securities representing more than 50% of the outstanding securities of any class of voting securities of Spring Bank or its
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subsidiaries; (ii) any sale , lease, exchange, transfer, license, acquisition or disposition of any business or businesses or assets that constitute or account for 75% or more of the consolidated net revenues, net income or assets of Spring Bank or its subsidiaries; or (iii) a liquidation or dissolution of Spring Bank or its subsidiaries, that the board of directors of Spring Bank determines in good faith (after consultation with its outside legal counsel and financial advisor) and after taking into account all financial, legal, regulatory, and other aspects of such Acquisition Proposal (including the financing terms and the ability of the third party to finance such transaction):
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to be reasonably likely to be consummated if accepted; and |
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to be more favorable to holders of Spring Bank common stock, from a financial point of view, than the Exchange, taking into account any changes to the terms of the Exchange Agreement offered by F-star or the holders of shares or convertible loan notes of F-star party to the Exchange Agreement in response to the offer. |
An offer will not be a Superior Offer unless either no financing is required to consummate the transaction contemplated by such offer or the required financing is committed subject to conditions no less favorable to Spring Bank than those set forth in the equity commitment letters and subscription agreements entered into in connection Pre-Closing Financing or the Spring Bank Board determines in good faith is reasonably capable of being obtained by such third party.
The Exchange Agreement also provides that each party will promptly advise the other of the status and terms of, and keep the other party informed in all material respects with respect to, any Acquisition Proposal or any inquiry, indication of interest or request for non-public information that could reasonably be expected to lead to an Acquisition Proposal or any modification or proposed modification thereto.
Spring Bank Acquisition Proposal and Acquisition Transaction
An Acquisition Proposal means, with respect to Spring Bank, any offer, proposal, inquiry or indication of interest contemplating or otherwise relating to any Acquisition Transaction (as defined below).
An Acquisition Transaction means the following:
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any merger, consolidation, amalgamation, share exchange, business combination, issuance or acquisition of securities, tender offer, exchange offer or similar transaction: in which Spring Bank or its subsidiaries is a constituent corporation; in which any individual, entity, governmental entity, or group, as defined in the Exchange Act and the rules thereunder, directly or indirectly acquires beneficial or record ownership of securities representing more than 20% of the outstanding securities of any class of voting securities of Spring Bank or its subsidiaries; or in which Spring Bank or its subsidiaries issues securities representing more than 20% of the outstanding securities of any class of voting securities of such entity; |
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any sale, lease, exchange, transfer, license, acquisition or disposition of any business or businesses or assets that constitute or account for 20% or more of the consolidated net revenues, net income or assets of Spring Bank or its subsidiaries; or |
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any liquidation or dissolution of Spring Bank or its subsidiaries. |
No Permitted Disposition (as defined in the Exchange Agreement) will constitute an Acquisition Transaction.
F-star Acquisition Proposal
An F-star Acquisition Proposal means any offer, proposal, inquiry or indication of interest contemplating or otherwise relating to any transaction or series of transactions involving:
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any merger, consolidation, amalgamation, share exchange, business combination, acquisition of securities, tender offer, exchange offer or similar transaction: in which F-star or any of its subsidiaries is a constituent corporation; in which any individual, entity, governmental entity, or group, as defined in the Exchange Act and the rules thereunder, directly or indirectly acquires beneficial or |
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record ownership of securities representing more than 20% of the outstanding securities of any class of voting securities of F-star or any of its subsidiaries; or in which F-star or any of its subsidiaries issues securities representing more than 20% of the outstanding voting securities of any class of securities of such entity; or |
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any sale, lease, exchange, transfer, acquisition or disposition of any business or businesses or assets that constitute 20% or more of the consolidated net revenues, net income or assets of F-star or its subsidiaries. |
However, none of the following constitutes an F-star Acquisition Proposal: (i) the issuance or potential issuance of securities by F-star or any of its subsidiaries representing less than 50% of the outstanding voting securities of F-star or any of its subsidiaries, on an as-converted basis, the Pre-Closing Financing or (ii) any license, collaboration or joint venture, or any transfer or disposition of assets in connection therewith, entered into or contemplated for bona fide business development purposes.
Covenants; Conduct of Business Pending the Exchange
F-star agreed in the Exchange Agreement that it will, and will cause its subsidiaries to, conduct their respective businesses prior to the Closing in the ordinary course of business consistent with past practice; provided that F-star may, in response to the coronavirus (COVID-19) pandemic, take such actions as F-star deems reasonably necessary or advisable to protect the health and safety of F-stars and its subsidiaries employees and other individuals having business dealings with F-star or its subsidiaries, to respond to orders or guidance from any governmental body imposed in response to, or third-party supply or service disruptions caused by, such pandemic, or to comply with any requirements imposed by third parties with whom F-star or any of its subsidiaries does business and in compliance in all material respects with all applicable legal requirements and requirements of all material contracts to which F-star or its subsidiaries is a party.
F-star also agreed that, except as otherwise contemplated by the Exchange Agreement and subject to certain limited exceptions, without the consent of Spring Bank, it will not, and will not permit its subsidiaries to, during the period prior to the Closing:
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amend or otherwise change any of the organizational documents of F-star or any of its subsidiaries, or effect or be a party to any merger, consolidation, share exchange business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction; |
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issue, sell, pledge, dispose of or encumber, or authorize the issuance, sale, pledge, disposition or encumbrance of, any shares of capital stock, or any options, warrants, convertible securities or other rights of any kind to acquire any shares of capital stock, or any other ownership interest (except for the issuance of (i) ordinary shares pursuant to options or restricted stock unit awards granted prior to the date of the Exchange Agreement, (ii) ordinary shares in the Pre-Closing Financing, (iii) up to $3,000,000 in aggregate principal amount of convertible loan notes, and (iv) ordinary shares in the Conversions); |
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except for the Conversions, redeem, repurchase or otherwise acquire any F-star share capital; |
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extend credit for borrowed money to any third party or incur any indebtedness for borrowed money or guarantee any indebtedness for borrowed money or issue or sell any debt securities or guarantee any debt securities or other obligations of others or sell, pledge, dispose of or create an encumbrance with respect to any assets (except for (i) sales of assets in the ordinary course of business and in a manner consistent with past practice, (ii) encumbrances created by operation of law or dispositions of obsolete or worthless assets, and (iii) the issuance of up to $3,000,000 in aggregate principal amount of convertible loan notes); |
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accelerate, amend or change the period (or permit any acceleration, amendment or change) of exercisability of options or warrants or authorize cash payments in exchange for any options; |
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declare, set aside, make or pay any dividend or other distribution in respect of any of its share capital, except for dividends from a wholly owned subsidiary to its parent; |
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split, combine or reclassify any of its share capital or issue or authorize or propose the issuance of any other securities in respect of, in lieu of or in substitution for shares of its share capital; |
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amend the terms of, repurchase, redeem or otherwise acquire, or permit any subsidiary to repurchase, redeem or otherwise acquire, any of its securities or any securities of its subsidiaries, or propose to do any of the foregoing; |
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sell, assign, transfer, license, sublicense or otherwise dispose of any F-star intellectual property rights (other than in the ordinary course of business); |
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materially change any royalty payments charged by F-star or any of its subsidiaries or materially change any royalty payments charged by any third parties who have licensed intellectual property rights to F-star or any of its subsidiaries other than in the ordinary course of business; |
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form any subsidiary; |
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acquire (by merger, consolidation, or acquisition of stock or assets) any corporation, partnership or other business organization or division thereof or any other material property or assets or any equity interest or other interest in any other entity or enter into a joint venture with any other entity; |
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forgive any loans to any person, including employees, officers, directors or affiliates; |
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take any action to change accounting policies or procedures other than as required by applicable legal requirements, IFRS, or U.S. GAAP; |
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make or change any material tax election inconsistent with past practice, change any material tax accounting method or settle or compromise any material tax liability except in any case as required by applicable legal requirements; |
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pay, discharge or satisfy any claims, liabilities or obligations (absolute, accrued, asserted or unasserted, contingent or otherwise), other than the payment, discharge or satisfaction of liabilities incurred in the ordinary course of business and consistent with past practice; |
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other than in the ordinary course of business, enter into or materially amend any material contract; |
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enter into or amend a contract that would reasonably be expected to prevent or materially impede, interfere with, hinder or delay the consummation of the Exchange; |
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settle or agree to settle any litigation, action, suit, proceeding, claim or arbitration, other than in the ordinary course of business; |
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amend, modify or waive any provision of any F-star Pre-Closing Financing Agreement which would be materially adverse to Spring Bank; or |
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take, or agree to take, any of the actions described above. |
Spring Bank agreed in the Exchange Agreement that it will, and will cause its subsidiaries to, conduct their respective businesses prior to the Closing in the ordinary course of business consistent with past practice; provided that Spring Bank may, in response to the COVID-19 pandemic, take such actions as Spring Bank deems reasonably necessary or advisable to protect the health and safety of Spring Banks and its subsidiaries employees and other individuals having business dealings with Spring Bank or its subsidiaries, to respond to orders or guidance from any governmental body imposed in response to, or third-party supply or service disruptions caused by, such pandemic, or to comply with any requirements imposed by third parties with whom Spring Bank or any of its subsidiaries does business and in compliance in all material respects with all applicable legal requirements and requirements of all material contracts to which Spring Bank or its subsidiaries is a party.
Spring Bank also agreed that, except as otherwise contemplated by the Exchange Agreement and subject to certain limited exceptions, without the consent of F-star, it will not, and will cause its subsidiaries not to, during the period prior to the Closing:
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amend or otherwise change any of the organizational documents of Spring Bank or any of its subsidiaries, or effect or be a party to any merger, consolidation, share exchange business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction, except for any Permitted Disposition; |
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issue, sell, pledge, dispose of or encumber, or authorize the issuance, sale, pledge, disposition or encumbrance of, any shares of capital stock, or any options, warrants, convertible securities or other rights of any kind to acquire any shares of capital stock, or any other ownership interest (except for shares issuable pursuant to options, restricted stock units or warrants granted or outstanding as of the date of the Exchange Agreement); |
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redeem, repurchase or otherwise acquire any shares of its common stock; |
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extend credit for borrowed money to any third party or incur any indebtedness for borrowed money or guarantee any indebtedness for borrowed money or issue or sell any debt securities or guarantee any debt securities or other obligations of others or sell, pledge, dispose of or create an encumbrance with respect to any assets (except for (i) encumbrances created pursuant to operation of law, (ii) pursuant to the terms of the Approved Development Transaction, or any Permitted Disposition, or (iii) dispositions of obsolete or worthless assets); |
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accelerate, amend or change the period (or permit any acceleration, amendment or change) of exercisability of options or warrants or authorize cash payments in exchange for any options or warrants, except as may be required under any Spring Bank option plan or contract or as may be required under applicable legal requirements; |
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declare, set aside, make or pay any dividend or other distribution in respect of any of its capital stock (other than the issuance of the CVRs in accordance with the CVR Agreements or the Permitted Dividend, if any), except for dividends from a wholly owned subsidiary to its parent; |
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split, combine or reclassify any of its capital stock or issue or authorize or propose the issuance of any other securities in respect of, in lieu of or in substitution for shares of its capital stock (other than the Reverse Stock Split); |
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amend the terms of, repurchase, redeem or otherwise acquire, or permit any subsidiary to repurchase, redeem or otherwise acquire, any of its securities or any securities of its subsidiaries, or propose to do any of the foregoing; |
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sell, assign, transfer, license, sublicense or otherwise dispose of any intellectual property rights, other than other than (i) the Approved Development Transaction, (ii) a Permitted Disposition or (iii) in the ordinary course of business; |
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materially change any royalty payment charged by Spring Bank or any of its subsidiaries or materially change any royalty payment charged by third persons who have licensed intellectual property rights to Spring Bank or any of its subsidiaries, except pursuant to the Approved Development Transaction or any Permitted Disposition; |
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form any Subsidiary, other than for the purpose of effecting the Approved Development Transaction or a Permitted Disposition; |
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acquire (by merger, consolidation, or acquisition of stock or assets) any corporation, partnership or other business organization or division thereof or any other material property or assets or any equity interest or other interest in another entity or enter into a joint venture with another entity; |
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forgive any loans to any person, including employees, officers, directors or affiliates; |
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other than as required by applicable legal requirements, (i) increase the compensation payable or to become payable to its directors, officers, employees or consultants, (ii) grant any severance, change in control, retention or termination pay to, or enter into any employment, severance or similar agreement with, any director, officer, employee or consultant, (iii) hire any new employee or consultant whose annual base salary is more than $150,000 per year, or (iv) establish, adopt, enter into, terminate or amend in any material respect any collective bargaining or similar agreement or benefit plan, or take any action to accelerate the time of payment or vesting of any compensation or benefits or take any action to fund or secure the funding of any compensation or benefits (other than qualified retirement plan benefits); |
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change accounting policies or procedures other than as required by applicable legal requirements or U.S. GAAP; |
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make or change any material tax election inconsistent with past practices, change any material tax accounting method or settle or compromise any material federal, state, local or foreign tax liability, except in each case as required by applicable legal requirements; |
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pay, discharge or satisfy any claims or liabilities (absolute, accrued, asserted or unasserted, contingent or otherwise), other than the payment, discharge or satisfaction in the ordinary course of business and consistent with past practice of liabilities reflected or reserved against in Spring Banks financial statements or incurred in the ordinary course of business and consistent with past practice; |
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enter into any partnership arrangements, joint development agreements or strategic alliances except in connection with the Approved Development Transaction or any Permitted Disposition; |
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except in connection with the Approved Development Transaction or any Permitted Disposition, enter into any contract (i) involving annual payments by Spring Bank or any of its subsidiaries greater than $25,000 in the aggregate, (ii) involving indemnification by Spring Bank or any of its subsidiaries, other than in the ordinary course of business, (iii) relating to intellectual property rights (other than confidentiality agreements, assignment of inventions agreements between Spring Bank or any of its subsidiaries and any employee thereof and non-exclusive licenses in the ordinary course of business), and/or (iv) that is not terminable for convenience without penalty; |
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amend in any material respect or terminate any material contract; |
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except in connection with the Approved Development Transaction, make any capital expenditure or capital commitment in excess of $25,000, other than capital expenditures or capital commitments in connection with the STING Trial, not to exceed $50,000 in the aggregate; |
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initiate any litigation, action, suit, proceeding, claim or arbitration, other than with certain vendors for repayment of amounts in dispute, or settle or agree to settle any litigation, action, suit, proceeding, claim or arbitration, other than any settlement which (i) provides a complete release of all claims against Spring Bank, and (ii) that does not involve the payment of any amount by Spring Bank in excess of $100,000 (after giving effect to any applicable insurance coverage); |
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fail to make any material payment with respect to any of Spring Banks or any of its subsidiaries accounts payable or indebtedness in a timely manner in accordance with their terms and consistent with past practices; |
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enter into or amend a contract that would reasonably be expected to prevent or materially impede, interfere with, hinder or delay the consummation of the Exchange; or |
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take, or agree to take, any of the actions described above. |
Other Agreements
Each of Spring Bank and F-star has agreed to use its commercially reasonable efforts to:
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take all actions necessary or advisable to satisfy the conditions to the obligations to close the Exchange and otherwise to complete the Exchange; |
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prepare and file all filings and give all notices required to be made and given in connection with the Exchange; |
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obtain all approvals, consents, ratifications, permissions, waivers or authorizations required to be obtained in connection with the Exchange; and |
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lift any restraint, injunction or other legal bar to the Exchange. |
In addition, F-star has agreed to use its commercially reasonable efforts to consummate the F-star Pre-Closing Financing for gross proceeds of at least $25.0 million.
Spring Bank and F-star agree that:
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for a period of six years after the Closing, Spring Bank will indemnify, hold harmless and provide advancement of expenses to each person who at any time prior to the date of the Exchange Agreement or prior to the Closing becomes a director or officer Spring Bank, F-star and their respective |
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subsidiaries (the D&O Indemnified Parties), to the fullest extent permitted under the applicable legal requirements and the organizational documents of Spring Bank, F-star or their respective subsidiaries; |
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from and after the Closing, Spring Bank will maintain directors and officers liability insurance policies (at F-stars expense) for Spring Bank, its subsidiaries, F-star and its subsidiaries effective as of the Closing date on commercially available terms and conditions and with customary coverage limits; |
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prior to the Closing, Spring Bank must purchase and fully pre-pay (at Spring Banks expense) a tail endorsement for the Spring Banks existing directors and officers insurance policies and Spring Banks existing fiduciary liability insurance policies, in each case, that provides a six-year extended reporting period from and after the Closing for claims first made against an individual insured for any alleged or actual wrongful act(s) that occurred prior to the Closing or the functional equivalent; |
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Spring Bank must (at F-stars expense) maintain products liability and human clinical trial liability insurance policies for Spring Bank and its subsidiaries with an effective date as of the date of Closing on commercially available terms and conditions and with customary coverage limits providing coverage for bodily injury or property damage caused by Spring Bank or its subsidiaries products, including bodily injury or property damage occurring in connection with human clinical trials, anywhere in the world |
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Prior to the Closing, Spring Bank must purchase and fully pre-pay (at F-stars expense) a tail endorsement to Spring Banks existing global products liability and human clinical trial liability insurance policy that provides a six-year extended reporting period from and after the Closing for claims for alleged bodily injury or property damage that occurred prior to the Closing in connection with Spring Banks or any of its subsidiaries products, including any alleged bodily injury or property damage occurring in connection with human clinical trials or the functional equivalent; and |
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Spring Bank will use commercially reasonable efforts to cause the shares of its common stock to be issued in connection with the Exchange to be approved for listing (subject to notice of issuance) on Nasdaq at or prior to the Closing. |
Permitted Dispositions; Approved Development Agreement
Spring Bank has the right to divest its Legacy Assets prior to the Closing in one or more Permitted Dispositions without the consent of F-star; provided, however, that if such Permitted Disposition results in the creation of ongoing obligations or liabilities of Spring Bank or any of its subsidiaries, the terms of such Permitted Disposition must be reasonably acceptable to F-star.
In addition, Spring Bank has the right to enter into an Approved Development Agreement prior to the Closing substantially on the terms and conditions previously disclosed to F-star subject to F-stars prior written consent, such consent not to be unreasonably withheld, delayed or conditioned.
Certain other restrictions will apply to any Permitted Disposition or the Approved Development Agreement.
Tax Cooperation
The parties to the Exchange Agreement intend that the Exchange constitute a tax-free reorganization within the meaning of Section 368(a) of the Code and have agreed to use their respective commercially reasonably efforts to take or cause to be taken any action necessary for the Exchange to qualify Section 368(a) of the Code. Qualification of the Exchange as a tax-free reorganization within the meaning of Section 368(a) of the Code is not a condition to Closing.
Termination
The Exchange Agreement may be terminated at any time before the Closing, whether before or after the approval by Spring Banks stockholders of the Company Stockholder Approval Matters, as set forth below:
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by mutual written consent duly authorized by the board of directors of each of Spring Bank and F-star; |
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by either Spring Bank or F-star if the Exchange has not been consummated on or before January 29, 2021; provided, that (a) the right to terminate the Exchange Agreement will not be available to any |
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party whose failure to fulfill any obligation under the Exchange Agreement has been the cause of or resulted in the failure of the Exchange to occur on or before such date, (b) such date shall be subject to extension to the extent required to calculate net cash in accordance with the Exchange Agreement, and (c) in the event that the SEC has not declared effective the registration statement of which this this proxy statement/prospectus forms a part by November 30, 2020 each of Spring Bank and F-star will be entitled to extend the date for termination of the Exchange Agreement for an additional 60 days; |
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by Spring Bank or F-star if a court of competent jurisdiction or governmental entity has issued a nonappealable final order, decree or ruling or taken any other action, in each case having the effect of permanently restraining, enjoining or otherwise prohibiting the Exchange; |
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by Spring Bank or F-star if (i) the Special Meeting (including any postponements and adjournments thereof) has been held and completed and the Spring Bank stockholders have taken a final vote on the issuance of the Spring Bank common stock in connection with the Exchange and the Reverse Stock Split, and (ii) the Spring Bank stockholders have not approved the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement or the Reverse Stock Split; provided that this right to terminate the Exchange Agreement will not be available to a party where the failure to obtain the approval of Spring Banks stockholders shall have been caused by the action or failure to act of such party and such action or failure to act constitutes a material breach by such party of the Exchange Agreement; |
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by Spring Bank or F-star if the other party has, or, in the case of Spring Bank, the holders of F-star shares or convertible loan notes who are parties to the Exchange Agreement have, breached any of its or their representations, warranties, covenants or agreements contained in the Exchange Agreement or if any representation or warranty of the other party or parties, respectively, has or have become inaccurate, in either case such that the conditions to the Closing relating thereto would not be satisfied as of time of such breach or inaccuracy, but if such breach or inaccuracy is curable, then the Exchange Agreement will not terminate as a result of a particular breach or inaccuracy unless it remains uncured as of the 30th day after the date of written notice given by the non-breaching party of such breach or inaccuracy and such partys intention to terminate the Exchange Agreement; |
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by Spring Bank or F-star if a Material Adverse Effect with respect to the other has occurred after the date of the Exchange Agreement, but such termination shall only be effective if, in the event the Material Adverse Effect is curable, such Material Adverse Effect is not cured within 30 days after the date of written by the unaffected party of the occurrence of the Material Adverse Effect and such partys intention to terminate the Exchange Agreement; |
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by F-star, at any time prior to the approval by Spring Banks stockholders of the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and the Reverse Stock Split, if: |
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the Spring Bank Board withdraws or modifies its recommendation that the stockholders of Spring Bank vote to approve the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and the Reverse Stock Split; |
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following the public disclosure of an Acquisition Proposal (other than a tender offer or exchange offer which is addressed below), the Spring Bank Board fails to publicly reaffirm the Spring Banks Board of Directors recommendation included in the preceding bullet point within five business days of Spring Banks written request; |
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Spring Bank enters into a letter of intent or definitive agreement relating to an Acquisition Proposal (other than a permitted confidentiality agreement); |
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Spring Bank or any director or officer of Spring Bank shall have willfully and intentionally breached the non-solicitation provisions of the Exchange Agreement, as described further in the section titled The Exchange AgreementNo Solicitation above; or |
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the Spring Bank Board shall have failed to recommend against or take a neutral position with respect to a tender or exchange offer relating to any Acquisition Proposal in any position taken pursuant to Rules 14d-9 and 14e-2 under the Exchange Act; |
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by Spring Bank, at any time prior to the approval by Spring Banks stockholders of the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and the Reverse Stock Split, if Spring Bank has received a Superior Offer, Spring Bank has complied with its obligations under the Exchange Agreement in order to accept the Superior Offer, Spring Bank concurrently terminates the Exchange Agreement and enters into a definitive agreement with respect to such Superior Offer, and Spring Bank pays to F-star a termination fee of $2.0 million no later than two business days following such termination; and |
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by Spring Bank, if the Pre-Closing Financing is terminated or does not occur prior to January 29, 2021; provided, however, this right to terminate is not available where the failure to obtain the Pre-Closing Financing shall have been caused by the action or failure to act of Spring Bank and such action or failure to act constitutes a material breach by Spring Bank of the Exchange Agreement. |
Termination Fee; Expenses
Spring Bank must pay F-star a termination fee of $2.0 million (less any amounts paid as an expense reimbursement, as applicable) if:
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the Exchange Agreement is terminated (i) by either F-star or Spring Bank based on the failure to close the Exchange on or before January 29, 2021, (ii) by either F-star or Spring Bank if the Spring Bank stockholder do not approve the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement or the Reverse Stock Split, or (iii) by F-star upon a breach of the Exchange Agreement or representations or warranties by Spring Bank; provided, that, an Acquisition Proposal has been publicly announced, disclosed or otherwise communicated to Spring Bank Board prior to such termination and, within nine months after the date of such termination, Spring Bank enters into a definitive agreement with respect to, or consummates, an Acquisition Transaction; |
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the Exchange Agreement is terminated by F-star based on (i) the Spring Bank Board withdrawing or modifying its recommendation that the stockholders of Spring Bank vote to approve the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and the Reverse Stock Split, (ii) following the public disclosure of an Acquisition Proposal (other than a tender offer or exchange offer which is addressed below), the Spring Bank Board failing to publicly reaffirm the Spring Bank Boards recommendation within five business days of Spring Banks written request, (iii) Spring Bank entering into a letter of intent or definitive agreement relating to an Acquisition Proposal (other than a permitted confidentiality agreement), (iv) Spring Bank or any director or officer of Spring Bank having willfully and intentionally breached the non-solicitation provisions of the Exchange Agreement, as described further in the section titled The Exchange AgreementNo Solicitation above, or (v) the Spring Bank Board having failed to recommend against or take a neutral position with respect to a tender or exchange offer relating to any Acquisition Proposal: and |
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the Exchange Agreement is terminated by Spring Bank, prior to obtaining the approval of Spring Banks stockholders of the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement and the Reverse Stock Split of Spring Bank common stock, if Spring Bank has received a Superior Offer, Spring Bank has complied in all material respects with its obligations under the Exchange Agreement in order to accept the Superior Offer, and Spring Bank concurrently terminates the Exchange Agreement and enters into a definitive agreement with respect to the Superior Offer. |
Spring Bank must reimburse F-star and its shareholders for fees and expenses incurred in connection with the Exchange Agreement and the transactions contemplated thereby, up to a maximum of $750,000, if the Exchange Agreement is terminated by either Spring Bank or F-star based on the Spring Bank stockholders not approving the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement or the Reverse Stock Split. Spring Bank will receive a credit for expenses paid in connection with the termination if a termination fee is also payable.
F-star must pay Spring Bank a termination fee of $2.0 million if the Exchange Agreement is terminated by Spring Bank, if the Pre-Closing Financing is terminated or does not occur prior to January 29, 2021 and the failure to obtain the Pre-Closing Financing shall not have been caused by the action or failure to act of Spring
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Bank if such action or failure to act would constitute a material breach by Spring Bank of the Exchange Agreement.
Amendment
The Exchange Agreement may be amended by the respective boards of directors of Spring Bank and F-star; provided that no representation, warranty or covenant in the Exchange Agreement with respect to an F-star shareholder or F-star convertible note holder party thereto may be amended in a manner adverse to an F-star shareholder of F-star convertible not holder party thereto unless such amendment applies to all such parties in the same fashion and the parties obtain the prior written approval of such amendment from the holders of at least 65% of the F-star share capital (after giving effect to the Conversions) except that: (i) any amendment or waiver to the director and officer indemnification provisions of the Exchange Agreement that adversely affects the D&O Indemnified Parties must be approved in writing by the D&O Indemnified Parties and (ii) after approval of the Transaction by the stockholders of Spring Bank no amendment may be made which by legal requirements requires further approval by such stockholders without such further approval.
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AGREEMENTS RELATED TO THE EXCHANGE
Voting Agreements
Each of the officers and directors and certain stockholders of Spring Bank have entered into Voting Agreements with F-star, whereby they have agreed to vote in favor of approval of (i) the issuance of Spring Bank common stock to the holders of F-star share capital pursuant to the Exchange, which will represent more than 20% of the shares of Spring Bank common stock outstanding immediately prior to the Exchange, and the change of control resulting from the Exchange, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively, (ii) an amendment to Spring Banks amended and restated certificate of incorporation effecting a reverse stock split of Spring Bank common stock at a ratio mutually agreed to between Spring Bank and F-star in the range of one new share for every to shares outstanding (or any number in between) (iii) an amendment to Spring Banks amended and restated certificate of incorporation to change the corporate name of Spring Bank from Spring Bank Pharmaceuticals, Inc. to F-star Therapeutics, Inc., (iv) any proposal to postpone or adjourn the meeting to a later date, if there are not sufficient votes for the approval of the Exchange and other matters to be approved on date of the Special Meeting, and (v) any other proposal included in this proxy statement/prospectus in connection with, or related to, the consummation of the Exchange for which the Spring Bank Board has recommended that the stockholders of Spring Bank vote in favor. Pursuant to the Voting Agreements, the stockholders of Spring Bank appointed F-star and its designee as its attorney-in-fact and proxy.
Each stockholder executing a Voting Agreement has made representations and warranties to F-star regarding ownership and unencumbered title to the securities subject to the Voting Agreements, such stockholders power and authority to execute the Voting Agreement, and due execution and enforceability of the Voting Agreement. Subject to the limitations on transfer set forth in the lock-up agreements with each of these stockholders described below under Lock-up Agreements, the Voting Agreement provides that the Voting Agreements will attach to the Spring Bank securities held by such stockholders and will be binding on any person to which legal or beneficial ownership of such securities passes, whether by operation of law or otherwise, including the stockholders successors and assigns, as well as any additional Spring Bank securities subsequently acquired by the stockholder.
The Spring Bank stockholders that are party to the Voting Agreements owned approximately 7.7% of the outstanding shares of Spring Bank common stock as of September 15, 2020.
The Voting Agreements will terminate at the earlier of closing of the Exchange or the termination of the Exchange Agreement in accordance with its terms.
Lock-up Agreements
As a condition to the Closing, certain Spring Bank stockholders and F-star shareholders have entered into lock-up agreements, pursuant to which they have agreed not to, except in limited circumstances, sell or transfer, or engage in swap or similar transactions with respect to, shares of Spring Bank common stock, including, as applicable, shares received in the Exchange and issuable upon exercise of certain options during the 180-day period immediately following the Closing.
As of September 15, 2020, Spring Bank stockholders who have executed lock-up agreements owned in the aggregate approximately 7.7% of the outstanding shares of Spring Bank common stock.
F-star shareholders who have executed lock-up agreements as of September 15, 2020 owned in the aggregate approximately 92.2% of the outstanding shares of F-star share capital on an as converted into common stock basis.
Contingent Value Rights Agreements
Spring Bank stockholders will receive two separate and distinct CVRs for each share of Spring Bank common stock held of record as of immediately prior to the Closing. The CVRs will represent the rights to receive cash payments in connection with (i) certain transactions involving Spring Banks proprietary STING agonist compound(the STING Agonist CVR Agreement) and (ii) certain other transactions involving Spring Banks proprietary STING antagonist compound,(the STING Antagonist CVR Agreement). At the Closing,
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Spring Bank, F-star, a representative of the Spring Bank stockholders prior to the Closing, and Computershare Trust Company N.A., as the Rights Agent, will enter into the STING Agonist CVR Agreement and the STING Antagonist CVR Agreement.
Pursuant to the Exchange Agreement and the STING Agonist CVR Agreement, each share of Spring Bank common stock held by Spring Bank stockholders as of a record date immediately prior to the Closing will receive a dividend of one contingent value right entitling such holders to receive, in connection with certain transactions involving Spring Banks proprietary STimulator of INterferon Genes (STING) agonist compound, designated as SB 11285, occurring on or prior to the STING Agonist CVR Expiration Date (as defined below) that result in aggregate Net Proceeds (as defined in the STING Agonist CVR Agreement) at least equal to the Target Payment Amount (as defined below): an aggregate amount equal to the greater of (i) 25% of the Net Proceeds received from all STING Agonist CVR Transactions (as defined in the STING Agonist CVR Agreement) and (ii) up to an aggregate amount of $18.0 million the product of $1.00 (as adjusted for the Reverse Stock Split, to the extent applicable) and the total number of shares of Spring Bank common stock outstanding as of such record date (the Target Payment Amount).
The CVR payment obligations expire on the later of 18 months following the Closing or the one-year anniversary of the date of the final database lock of the Companys current STING Trial (as defined in the STING Agonist CVR Agreement) (the STING Agonist CVR Expiration Date). The STING Agonist CVRs will not be transferable, except in certain limited circumstances, will not be certificated or evidenced by any instrument, will not accrue interest and will not be registered with the SEC or listed for trading on any exchange. Until the STING Agonist CVR Expiration Date, subject to certain exceptions, F-star will be required to use commercially reasonable efforts to (a) complete the STING Trial and (b) pursue STING Agonist CVR Transactions. Unless terminated earlier in accordance with its terms, the STING Agonist CVR Agreement will be effective upon the Closing and will continue in effect until the payment of all STING Agonist CVR payment amounts payable pursuant to its terms.
Pursuant to the Exchange Agreement and the STING Antagonist CVR Agreement, each share of Spring Bank common stock held by Spring Bank stockholders as of a record date immediately prior to the Closing will receive a dividend of one contingent value right entitling such holders to receive, in connection with the execution of an Approved Development Agreement and certain other transactions involving Spring Banks proprietary STING antagonist compound occurring on or prior to the STING Antagonist CVR Expiration Date (as defined above), an aggregate amount equal to: 80% of all Net Proceeds (as defined in the STING Antagonist CVR Agreement) received by the Company after the Closing pursuant to (i) the Approved Development Agreement, if any, and (ii) all STING Antagonist CVR Transactions (as defined in the STING Antagonist CVR Agreement) entered into prior to the STING Antagonist CVR Expiration Date.
The CVR payment obligations expire on the seventh anniversary of the Closing. The STING Antagonist CVRs will not be transferable, except in certain limited circumstances, will not be certificated or evidenced by any instrument, will not accrue interest and will not be registered with the SEC or listed for trading on any exchange. Until the STING Antagonist CVR Expiration Date, subject to certain exceptions, F-star will be required to use commercially reasonable efforts to (a) consummate the Approved Development Agreement to the extent not entered into prior to Closing, (b) to perform the terms of the Approved Development Agreement and (c) pursue STING Antagonist CVR Transactions. Unless terminated earlier in accordance with its terms, the STING Antagonist CVR Agreement will be effective upon the Closing and will continue in effect until the payment of all STING Antagonist CVR payment amounts payable pursuant to its terms.
Material U.S. Federal Income Tax Consequences of the Receipt of CVRs to U.S. Holders
The following discussion is a summary of the material U.S. federal income tax consequences applicable to U.S. Holders (as defined below) of Spring Bank common stock who receive CVRs with respect to such Spring Bank common stock. This discussion does not purport to be a complete analysis of all potential tax consequences resulting from the receipt of, and payments on, the CVRs.
This discussion is based upon the Code, Treasury regulations, judicial authorities, published positions of the IRS and other applicable authorities, all as currently in effect and all of which are subject to change or differing
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interpretations (possibly with retroactive effect). Any such change or interpretation could affect the continuing validity of this discussion. Spring Bank has not sought and does not intend to seek any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a position contrary to that discussed below regarding the tax consequences of the receipt of CVRs. This discussion is limited to U.S. Holders that hold their shares of Spring Bank common stock as capital assets within the meaning of Section 1221 of the Code. This discussion does not address all of the tax consequences that may be applicable to a particular Spring Bank stockholder or to Spring Bank stockholders that are subject to special treatment under U.S. federal income tax laws, such as:
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shareholders that are not U.S. Holders; |
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financial institutions; |
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investors in pass-through entities, including (but not limited to) partnerships or limited liability companies treated as partnerships for tax purposes; |
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insurance companies; |
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tax-exempt organizations; |
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pension plans; |
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controlled foreign corporations; |
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passive foreign investment companies; |
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corporations that accumulate earnings to avoid U.S. federal income tax; |
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regulated investment companies or real estate investment trusts; |
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brokers or dealers in securities or currencies; |
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certain expatriates or persons whose functional currency is not the U.S. dollar; |
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traders in securities that elect to use a mark to market method of accounting; |
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persons that hold Spring Bank common stock as part of a straddle, hedge, constructive sale, synthetic security or other integrated investment, or conversion transaction; and |
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persons that received Spring Bank common stock upon the conversion of a convertible note or any other convertible instrument; |
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U.S. Holders that acquired their shares of Spring Bank common stock through the exercise of an employee stock option or otherwise as compensation. |
In addition, this discussion does not address any alternative minimum tax or any state, local or foreign tax consequences of the Exchange, nor does it address any tax consequences arising under the unearned income Medicare contribution tax pursuant to the Health Care and Education Reconciliation Act of 2010.
If a partnership or other entity taxed as a partnership holds Spring Bank common stock, the tax treatment of a partner in the partnership generally will depend upon the status of the partner, the activities of the partnership and certain determinations made at the partner level. Partnerships and partners in such a partnership should consult their tax advisors about the tax consequences of the Exchange to them.
For purposes of this discussion, the term U.S. Holder means a beneficial owner of Spring Bank common stock that for U.S. federal income tax purposes is:
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a citizen or resident of the United States; |
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a corporation, or other entity treated as a corporation, created or organized in or under the laws of the United States or any state or political subdivision thereof; |
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an estate that is subject to U.S. federal income tax on its income regardless of its source; or |
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a trust, the substantial decisions of which are controlled by one or more U.S. persons and which is subject to the primary supervision of a U.S. court, or a trust that validly has elected under applicable Treasury regulations to be treated as a U.S. person for U.S. federal income tax purposes. |
THIS DISCUSSION IS FOR INFORMATION PURPOSES ONLY AND IS NOT TAX ADVICE. HOLDERS SHOULD CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE APPLICATION
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OF THE U.S. FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AS WELL AS ANY TAX CONSEQUENCES OF THE RECEIPT OF CVRs ARISING UNDER THE U.S. FEDERAL ESTATE OR GIFT TAX LAWS OR UNDER THE LAWS OF ANY STATE, LOCAL OR NON-U.S. TAXING JURISDICTION OR UNDER ANY APPLICABLE INCOME TAX TREATY.
Receipt of CVRs by Spring Bank U.S. Holders
There is substantial uncertainty as to the U.S. federal income tax treatment of CVRs. Specifically, there is no authority directly addressing whether the issuance of contingent value rights with characteristics similar to the CVRs should be treated as a distribution of property with respect to the Spring Banks common stock, a distribution of equity, or a debt instrument or an open transaction for U.S. federal income tax purposes. The CVRs have certain characteristics similar to a distribution of equity, or a debt instrument or an open transaction, and there is no legal authority directly addressing what characteristics are determinative of how contingent value rights with characteristics similar to the CVRs should be taxed. As a result, it is not possible to express a definitive conclusion as to the tax treatment of the issuance of the CVRs, and Spring Bank has not requested or received an opinion of counsel regarding such treatment. Applicable Treasury regulations provide that open transaction treatment is only available in those rare and extraordinary cases involving contingent payment obligations in which the fair market value of the obligation cannot reasonably be ascertained. Notwithstanding such uncertainty, based on the specific characteristics of the CVRs, and unless otherwise required by a change in law after the date of the CVR Agreement, Spring Bank intends to take the position that the fair market value of the CVRs cannot be reasonably ascertained on the date of the issuance of the CVRs and, accordingly, the issuance of the CVRs constitutes an open transaction. Therefore, absent a change in law requiring otherwise, for U.S. federal income tax purposes, Spring Bank will not report the issuance of the CVRs as a current distribution of property with respect to its common stock and will instead report each future cash payment (if any) on the CVRs as a distribution in the year in which such payment is made, with each such payment being reported as a dividend to the extent of Spring Banks current or accumulated earnings and profits in the year in which such payment is made.
If the issuance of the CVRs is treated as an open transaction, a U.S. Holder would generally not recognize income in respect of the CVRs at the time such CVRs are issued and would take no tax basis in the CVRs. Future cash payments (if any) on the CVRs would be treated as a distribution and constitute a dividend to the extent of the U.S. Holders pro rata share of Spring Bank current or accumulated earnings and profits (as determined for U.S. federal income tax purposes) in the taxable year of such payment, then as a non-taxable return of capital to the extent of the U.S. Holders basis in its Spring Bank common stock, and finally as capital gain from the sale or exchange of Spring Bank common stock with respect to any remaining payment. Dividends received by individual U.S. Holders are currently eligible for reduced rates of taxation applicable to long-term capital gains, provided certain holding period requirements are met.
As indicated above, there is substantial uncertainty as to the U.S. federal income tax treatment of the CVRs. If instead, the issuance of the CVRs is treated as a distribution of property, each U.S. Holder of Spring Bank common stock would be treated as receiving a distribution in an amount equal to the fair market value of the CVRs issued to such U.S. Holder on the date of the issuance. Such distribution generally would be treated as a dividend to the extent of the U.S. Holders pro rata share of Spring Bank current or accumulated earnings and profits (as determined for U.S. federal income tax purposes), then as a non-taxable return of capital to the extent of the U.S. Holders basis in its Spring Bank common stock, and finally as capital gain from the sale or exchange of Spring Bank common stock with respect to any remaining value. Spring Bank believes it does not have a material amount of accumulated earnings and profits, and expects no or a small amount of current earnings and profits for the relevant taxable year. Accordingly, even if the distribution of the CVRs is treated as a distribution Spring Bank expects most or all of such distribution would be treated as a return of capital or as capital gains for U.S. federal income tax purposes. In such case, a U.S. Holders initial tax basis in such holders CVRs would equal the fair market value of such CVRs on the date of their issuance. The holding period of such CVRs would begin on the day after the date of issuance. Although not free from doubt, a future cash payment under a CVR would likely be treated as a non-taxable return of a U.S. Holders adjusted tax basis in the CVR to the extent thereof, although the timing of the recovery of a U.S. Holders tax basis is unclear. A payment in excess of such amount may be treated as a payment with respect to a sale of a
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capital asset, ordinary income or dividends. Additionally, it is possible that a portion of future cash payments would constitute imputed interest and taxed as such. A U.S. Holder might recognize loss, which might be a capital loss and could be a long-term capital loss, upon the expiration of the CVR to the extent cash payments ultimately received pursuant to such CVR were less than the U.S. Holders adjusted tax basis in the CVRs, but whether and when such a loss would be recognized is unclear. The deductibility of capital losses is subject to limitations.
If the issuance of the CVRs is treated as a distribution of equity, U.S. Holders would generally not recognize gain or loss as a result of the issuance of the CVRs. Depending on the fair market value of the CVRs and the Spring Bank common stock on the date that the CVRs are issued, each U.S. Holders tax basis in such holders Spring Bank common stock would be allocated between such U.S. Holders Spring Bank common stock and such U.S. Holders CVRs. The holding period of such CVRs would include the U.S. Holders holding period of such holders Spring Bank common stock. Future payments on a CVR received by a U.S. Holder would likely be treated as dividends to the extent of the U.S. Holders pro rata share of Spring Banks current or accumulated earnings and profits (as determined for U.S. federal income tax purposes), then as a non-taxable return of capital to the extent of the U.S. Holders basis in the CVR, and finally as capital gain from the sale or exchange of the CVR with respect to any remaining value.
If the CVRs are treated as one or more debt instruments, then payments received with respect to the CVRs would likely be treated as payments in retirement of a debt instrument, except to the extent of interest imputed under the Code. If this tax treatment were to apply, interest generally would be imputed under complex rules. In such a case, a U.S. Holder would be required to include any such interest in income on an annual basis, whether or not currently paid.
Alternative Treatment of the Receipt of CVRs and the Reverse Stock Split as a Single Recapitalization
Although the matter is not free from doubt, Spring Bank intends to treat the distribution of the CVRs to U.S. Holders of Spring Bank common stock and the Reverse Stock Split as separate transactions for U.S. federal income tax purposes. Notwithstanding Spring Banks position that the receipt of CVRs and the Reverse Stock Split are appropriately treated as separate transactions, it is possible that the IRS or a court could determine that the receipt of the CVRs and the Reverse Stock Split constitute a single recapitalization for U.S. federal income tax purposes. In such case, the tax consequences of the receipt of CVRs and the Reverse Stock Split would differ from those described above and would depend in part on many of the same considerations described above, including whether the distribution of the CVRs is treated as a current distribution of property, equity or debt instruments or instead is subject to the open transaction doctrine.
PLEASE CONSULT YOUR TAX ADVISOR WITH RESPECT TO THE PROPER CHARACTERIZATION OF THE RECEIPT OF THE CVRs.
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MATTERS BEING SUBMITTED TO A VOTE OF SPRING BANK STOCKHOLDERS
PROPOSAL NO. 1:
APPROVAL OF THE ISSUANCE OF COMMON STOCK IN THE EXCHANGE, WHICH WILL RESULT IN A CHANGE OF CONTROL OF SPRING BANK
At the Special Meeting, Spring Bank stockholders will be asked to approve the issuance of shares of Spring Bank common stock to the holders of F-star share capital pursuant to the Exchange Agreement. Immediately following the Exchange, based on an assumed Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the Spring Bank securityholders and holders of F-stars share capital are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company. The Exchange Ratio is subject to adjustment prior to the Closing and the holders of F-star share capital could own more or less, and the holders of Spring Bank capital stock could own more or less, of the combined company than currently anticipated. F-star ordinary shares that are issued in the Pre-Closing Financing will be converted into shares of Spring Bank common stock in the Exchange. Accordingly, by approving Proposal No. 1, Spring Bank stockholders will also be approving the issuance of shares of Spring Bank common stock to be issued in exchange for all F-star securities sold in the Pre-Closing Financing.
Nasdaq Listing Rule 5635(a)(1) requires a company listed on Nasdaq to obtain stockholder approval prior to the issuance of common stock, among other things, in connection with the acquisition of the stock or assets of another company, if the number of shares of common stock to be issued is equal to or in excess of 20% of the number of shares of common stock then outstanding. The proposed issuance of the shares of Spring Bank common stock in the Exchange will exceed the 20% threshold under the Nasdaq Listing Rules. Accordingly, in order to ensure compliance with Nasdaq Listing Rule 5635(a)(1), Spring Bank must obtain stockholder approval for the issuance of the shares of Spring Bank common stock in the Exchange.
Nasdaq Listing Rule 5635(b) requires a company listed on Nasdaq to obtain stockholder approval prior to an issuance of securities that will result in a change of control of an issuer. Although Nasdaq has not adopted any rule as to what constitutes a change of control for purposes of Rule 5635(b), Nasdaq has previously indicated that the acquisition of, or right to acquire, by a single investor or affiliated investor group, as little as 20% of the common stock (or securities convertible into or exercisable for common stock) or voting power of an issuer could constitute a change of control. In addition, it is anticipated that Nasdaq will deem the Exchange to be a change of control. Accordingly, in order to ensure compliance with Nasdaq Listing Rule 5635(b), Spring Bank must obtain stockholder approval for the potential change in control of Spring Bank resulting from the Exchange.
The terms of, reasons for and other aspects of the Exchange Agreement, the Exchange and the issuance of shares of Spring Bank common stock pursuant to the Exchange Agreement are described in detail in the other sections in this proxy statement/prospectus.
Required Vote
The affirmative vote of a majority of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter required for approval of Proposal No. 1.
THE SPRING BANK BOARD RECOMMENDS THAT THE SPRING BANK STOCKHOLDERS VOTE FOR PROPOSAL NO. 1 TO APPROVE THE ISSUANCE OF SPRING BANK COMMON STOCK PURSUANT TO THE EXCHANGE AGREEMENT.
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PROPOSAL NO. 2:
APPROVAL OF AN AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF
INCORPORATION OF SPRING BANK EFFECTING THE REVERSE STOCK SPLIT
General
At the Special Meeting, Spring Bank stockholders will be asked to approve and adopt the amendment to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split. Upon the effectiveness of the amendment to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split, or the split effective time, the issued shares of Spring Bank common stock immediately prior to the split effective time will be reclassified into a smaller number of shares such that a Spring Bank stockholder will own one new share of Spring Bank common stock for every shares to one new share for every shares of issued common stock held by that stockholder immediately prior to the split effective time.
If Spring Bank Proposal No. 2 is approved, the Reverse Stock Split would become effective in connection with the Closing. The Spring Bank Board may effect only one reverse stock split in connection with this Spring Bank Proposal No. 2. The Spring Bank Boards decision will be based on a number of factors, including market conditions, existing and expected trading prices for Spring Bank common stock and the listing requirements of the Nasdaq Capital Market.
The Spring Bank Board may determine to effect the Reverse Stock Split, if it is approved by the stockholders, even if the Exchange is not completed. The Spring Bank Board of Directors also reserves the right to not effect the Reverse Stock Split, even if it is approved by the stockholders.
Spring Banks authorized capital stock currently consists of 200,000,000 shares of common stock, par value $0.0001 per share and 10,000,000 shares of preferred stock, par value $0.0001 per share. The Reverse Stock Split will not change the number of authorized shares of Spring Bank common stock or preferred stock, or the par value of Spring Bank common stock or preferred stock. As of September 15, 2020, 17,248,545 shares of Spring Bank common stock were issued and outstanding, which would equate to shares of common stock if the Reverse Stock Split is effectuated at a ratio of to one, and shares of common stock if the Reverse Stock Split is effectuated at a ratio of to one.
Immediately following the issuance of shares of Spring Bank common stock described in Proposal No. 1, Spring Bank will have shares of common stock issued and outstanding, based on an assumed Exchange Ratio of 0.5338 and after giving effect to the Reverse Stock Split at a ratio of (the midpoint of the range presented for approval) to one.
Purpose
The Spring Bank Board approved the proposed amendment to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split for the following reasons:
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the Board of Directors believes a higher stock price may help generate investor interest in Spring Bank or the combined company and help Spring Bank or the combined company attract and retain employees; and |
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a stock price of at least $4.00 per share will be required by Nasdaq in order to approve the initial listing of the combined company following the Exchange. |
If the Reverse Stock Split successfully increases the per share price of Spring Bank common stock, the Spring Bank Board believes this increase may increase trading volume in Spring Bank common stock and facilitate future financings by Spring Bank or the combined company.
Nasdaq Requirements for Listing on the Nasdaq Capital Market
Spring Bank common stock is quoted on the Nasdaq Capital Market under the symbol SBPH. According to Nasdaq rules, an issuer must apply for initial inclusion following a transaction whereby the issuer combines with a non-Nasdaq entity, resulting in a change of control of the issuer and potentially allowing the non-Nasdaq
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entity to obtain a Nasdaq listing. Accordingly, the listing standards of Nasdaq will require the combined company to have, among other things, a $4.00 per share minimum bid price upon the Closing. Therefore, the Reverse Stock Split will be necessary in order to consummate the Exchange.
One of the effects of the Reverse Stock Split will be to effectively increase the proportion of authorized shares that are unissued relative to those which are issued. This could result in the combined companys management being able to issue more shares without further stockholder approval. For example, before the Reverse Stock Split, Spring Banks authorized but unissued shares immediately prior to the Closing would be approximately 182.8 million compared to shares issued of approximately 17.2 million. If Spring Bank effects the Reverse Stock Split using a to ratio, its authorized but unissued shares immediately following the Closing would be approximately compared to shares issued of approximately . Spring Bank currently has no plans to issue shares other than in connection with the Exchange, and to satisfy obligations under Spring Banks equity incentive plans from time to time as Spring Bank options are exercised. The Reverse Stock Split will not affect the number of authorized shares of Spring Bank common stock, which will continue to be authorized pursuant to the certificate of incorporation of Spring Bank.
Potential Increased Investor Interest
On , 2020, the last trading price Spring Bank common stock as reported by the Nasdaq Capital Market was $ per share. An investment in Spring Bank common stock may not appeal to brokerage firms that are reluctant to recommend lower priced securities to their clients. Investors may also be dissuaded from purchasing lower priced stocks because the brokerage commissions, as a percentage of the total transaction, tend to be higher for such stocks. Moreover, the analysts at many brokerage firms do not monitor the trading activity or otherwise provide coverage of lower priced stocks. Also, the Spring Bank Board believes that most investment funds are reluctant to invest in lower priced stocks.
There are risks associated with the reverse stock split, including that the reverse stock split may not result in an increase in the per share price of Spring Bank common stock.
Spring Bank cannot predict whether the reverse stock split will increase the market price for Spring Bank common stock. The history of similar stock split combinations for companies in like circumstances is varied. There is no assurance that:
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the market price per share of Spring Bank common stock after the reverse stock split will rise in proportion to the reduction in the number of shares of Spring Bank common stock outstanding before the Reverse Stock Split; |
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the Reverse Stock Split will result in a per share price that will attract brokers and investors who do not trade in lower priced stocks; |
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the Reverse Stock Split will result in a per share price that will increase the ability of Spring Bank to attract and retain employees; or |
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the market price per share will either exceed or remain in excess of the $4.00 minimum bid price as required by Nasdaq for the listing of the combined companys common stock. |
The market price of Spring Bank common stock will also be based on performance of Spring Bank and other factors, some of which are unrelated to the number of shares outstanding. If the Reverse Stock Split is effected and the market price of Spring Bank common stock declines, the percentage decline as an absolute number and as a percentage of the overall market capitalization of Spring Bank may be greater than would occur in the absence of a reverse stock split. Furthermore, the liquidity of Spring Bank common stock could be adversely affected by the reduced number of shares that would be outstanding after the Reverse Stock Split.
Principal Effects of the Reverse Stock Split
The amendment to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split is set forth in Annex C to this proxy statement/prospectus.
The Reverse Stock Split will be effected simultaneously for all outstanding shares of Spring Bank common stock. The Reverse Stock Split will affect all of the Spring Bank stockholders uniformly and will not affect any
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stockholders percentage ownership interests in Spring Bank, except to the extent that the Reverse Stock Split results in any of the Spring Bank stockholders owning a fractional share. Common stock issued pursuant to the Reverse Stock Split will remain fully paid and nonassessable. The Reverse Stock Split does not affect the total proportionate ownership of Spring Bank following the Exchange. The Reverse Stock Split will not affect Spring Bank continuing to be subject to the periodic reporting requirements of the Exchange Act.
Spring Bank has no current plans, arrangements or understandings to issue shares that will be available and unreserved after the completion of the Exchange and the other transactions described in this proxy statement/prospectus, other than in connection with the Exchange and to satisfy obligations under the combined companys warrants and stock options from time to time as such warrants and options are exercised. In addition to the Pre-Closing Financing and as discussed in F-star Managements Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources, if the Exchange is completed, the combined company may from time to time seek to finance future cash needs through financings that may take the form of a public or private equity offering. An equity financing in addition to the Pre-Closing Financing could occur at any time, including as soon as immediately after completion of the Exchange.
Procedure for Effecting Reverse Stock Split and Exchange of Stock Certificates
If the Spring Bank stockholders approve the amendment to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split, and if the Spring Bank Board still believes that a reverse stock split is in the best interests of Spring Bank and its stockholders, Spring Bank will file the certificate of amendment to the amended and restated certificate of incorporation with the Secretary of State of the State of Delaware at such time as the Spring Bank Board has determined to be the appropriate split effective time. The Spring Bank Board may delay effecting the Reverse Stock Split without resoliciting stockholder approval. Beginning at the split effective time, each certificate representing pre-split shares will be deemed for all corporate purposes to evidence ownership of post-split shares.
As soon as practicable after the split effective time, stockholders will be notified that the Reverse Stock Split has been effected. Spring Bank expects that the Spring Bank transfer agent will act as exchange agent for purposes of implementing the exchange of stock certificates. Holders of pre-split shares will be asked to surrender to the exchange agent certificates representing pre-split shares in exchange for certificates representing post-split shares in accordance with the procedures to be set forth in a letter of transmittal to be sent by Spring Bank. In the event that Proposal No. 3 is approved and the Exchange is completed, the certificates reflecting the post-split shares will also reflect the change of the Spring Bank corporate name to F-star Therapeutics, Inc. No new certificates will be issued to a stockholder until such stockholder has surrendered such stockholders outstanding certificate(s) together with the properly completed and executed letter of transmittal to the exchange agent. Any pre-split shares submitted for transfer, whether pursuant to a sale or other disposition, or otherwise, will automatically be exchanged for post-split shares. Stockholders should not destroy any stock certificate(s) and should not submit any certificate(s) unless and until requested to do so.
Fractional Shares
No fractional shares will be issued in connection with the reverse stock split. Stockholders of record who otherwise would be entitled to receive fractional shares because they hold a number of pre-split shares not evenly divisible by the number of pre-split shares for which each post-split share is to be reclassified, will be entitled, upon surrender to the exchange agent of certificates representing such shares, to a cash payment equal to the product of such fraction to which the stockholder would otherwise be entitled multiplied by the closing price of Spring Banks common stock on the Nasdaq Capital Market on the last trading day prior to the reverse stock split effective time (as adjusted to give effect to the reverse stock split), rounded up to the nearest whole cent. The ownership of a fractional interest will not give the holder thereof any voting, dividend, or other rights except to receive payment therefor as described herein.
By approving the amendment to the amended and restated certificate of incorporation of Spring Bank effecting the Reverse Stock Split, stockholders will be approving the combination of to shares of Spring Bank common stock into one share of Spring Bank common stock.
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Stockholders should be aware that, under the escheat laws of the various jurisdictions where stockholders reside, where Spring Bank is domiciled, and where the funds will be deposited, sums due for fractional interests that are not timely claimed after the effective date of the split may be required to be paid to the designated agent for each such jurisdiction, unless correspondence has been received by Spring Bank or the exchange agent concerning ownership of such funds within the time permitted in such jurisdiction. Thereafter, stockholders otherwise entitled to receive such funds will have to seek to obtain them directly from the state to which they were paid.
Potential Anti-Takeover Effect
Although the increased proportion of unissued authorized shares to issued shares could, under certain circumstances, have an anti-takeover effect, for example, by permitting issuances that would dilute the stock ownership of a person seeking to effect a change in the composition of the Spring Bank Board or contemplating a tender offer or other transaction for the combination of Spring Bank with another company, the Reverse Stock Split proposal is not being proposed in response to any effort of which Spring Bank is aware to accumulate shares of Spring Bank common stock or obtain control of Spring Bank, other than in connection with the Exchange, nor is it part of a plan by management to recommend a series of similar amendments to the Spring Bank Board and stockholders. Other than the proposals being submitted to the Spring Bank stockholders for their consideration at the Special Meeting, the Spring Bank Board does not currently contemplate recommending the adoption of any other actions that could be construed to affect the ability of third parties to take over or change control of Spring Bank. For more information, see the sections titled Risk FactorsRisks Related to the Common Stock of Spring Bank, and Description of Spring Bank Capital StockAnti-Takeover Effects of Provisions of Delaware Law and Spring Banks Certificate of Incorporation and Bylaws in this proxy statement/prospectus.
Material U.S. Federal Income Tax Consequences of the Reverse Stock Split to U.S. Holders
Although the matter is not free from doubt, Spring Bank intends to treat the reverse stock split and the receipt of the CVRs as separate transactions for U.S. federal income tax purposes, and the following discussion assumes this treatment will be respected.
Other than cash payments for fractional shares discussed below, Spring Bank believes that no gain or loss should be recognized by a U.S. Holder upon such stockholders exchange of pre-split shares for post-split shares pursuant to the Reverse Stock Split. The aggregate tax basis of the post-split shares received in the Reverse Stock Split, including any fraction of a post-split share deemed to have been received, will be the same as the stockholders aggregate tax basis in the pre-split shares that are exchanged. A U.S. Holders holding period for the post-split shares will include the period during which the U.S. Holder held the pre-split shares surrendered in the Reverse Stock Split.
In general, U.S. Holders who receive cash upon redemption of their fractional share interests in the post-split shares as a result of the Reverse Stock Split, will recognize gain or loss equal to the difference between their basis in the fractional share and the amount of cash received. Such gain or loss will be capital gain or loss, and generally will constitute a long-term capital gain or loss if the U.S. Holders holding period in the stock surrendered is more than one year as of the effective time of the Reverse Stock Split. Long-term capital gain are currently subject to U.S. federal income tax at reduced rates in the case of non-corporate U.S. Holders. The deductibility of capital losses is subject to various limitations for corporate and non-corporate U.S. Holders. U.S. Holders who acquired different blocks of stock at different times for different prices must calculate their gains and losses and holding periods separately for each identifiable block of such stock surrendered in the Reverse Stock Split.
Alternative Treatment of the Reverse Stock Split and the Receipt of the CVRs as a Single Recapitalization
Notwithstanding Spring Banks position that the Reverse Stock Split and the receipt of the CVRs are appropriately treated as separate transactions, it is possible that the IRS or a court could determine that the Reverse Stock Split and the receipt of the CVRs constitute a single recapitalization for U.S. federal income tax
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purposes. In such case, the U.S. federal income tax consequences of the Reverse Stock Split and the receipt of CVRs would differ from those described above. Please see the section titled Agreements Related to the Share ExchangeMaterial U.S. Federal Income Tax Consequences of the Receipt of CVRsAlternative Treatment of the Receipt of CVRs and the Reverse Stock Split as a Single Recapitalization in this proxy statement/prospectus.
Spring Banks view regarding the tax consequence of the Reverse Stock Split is not binding on the IRS or the courts. Accordingly, each stockholder should consult with such stockholders tax advisor with respect to all of the potential tax consequences to such stockholder of the Reverse Stock Split.
Vote Required; Recommendation of Board of Directors
The affirmative vote of holders of a majority of the shares of Spring Bank common stock having voting power outstanding on the Record Date for the Special Meeting is required for approval of Proposal No. 2.
THE SPRING BANK BOARD RECOMMENDS THAT SPRING BANK STOCKHOLDERS VOTE FOR PROPOSAL NO. 2 TO APPROVE AN AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF SPRING BANK EFFECTING THE REVERSE STOCK SPLIT.
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PROPOSAL NO. 3: APPROVAL OF AN AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF SPRING BANK EFFECTING THE SPRING BANK NAME CHANGE
At the Special Meeting, Spring Bank stockholders will be asked to approve an amendment to the certificate of incorporation of Spring Bank to effect the Spring Bank Name Change. The primary reason for the Spring Bank Name Change is that management believes this will allow for brand recognition of F-stars product candidates and product candidate pipeline following the consummation of the Exchange. Spring Banks management believes that the current name will no longer accurately reflect the business of Spring Bank and the mission of Spring Bank subsequent to the consummation of the Exchange.
Required Vote
The affirmative vote of holders of a majority of the shares of Spring Bank common stock having voting power outstanding on the Record Date for the Special Meeting is required for approval of Proposal No. 3.
This Proposal No. 3 is conditioned upon the consummation of the Exchange. If the Exchange is not completed or the Stockholders do not approve Proposal No. 3, Spring Banks name will not be changed.
THE SPRING BANK BOARD RECOMMENDS THAT SPRING BANK STOCKHOLDERS VOTE FOR PROPOSAL NO. 3 TO APPROVE AN AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF SPRING BANK EFFECTING THE SPRING BANK NAME CHANGE.
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PROPOSAL NO. 4:
APPROVAL OF POTENTIAL POSTPONEMENT OR ADJOURNMENT OF THE SPECIAL MEETING
If Spring Bank fails to receive a sufficient number of votes to approve Proposal Nos. 1, 2 or 3, Spring Bank may propose to adjourn the Special Meeting, for a period of not more than 30 days, for the purpose of soliciting additional proxies to approve Proposal Nos. 1, 2 or 3. Spring Bank currently does not intend to propose adjournment at the Special Meeting if there are sufficient votes to approve Proposal Nos. 1, 2 and 3.
Required Vote
The affirmative vote of a majority of the voting power of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter is required for the approval of Proposal No. 4.
THE SPRING BANK BOARD RECOMMENDS THAT THE SPRING BANK STOCKHOLDERS VOTE FOR PROPOSAL NO. 4 TO POSTPONE OR ADJOURN THE SPECIAL MEETING, IF NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF PROPOSAL NOS. 1, 2 or 3.
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Spring Bank is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of a range of cancers and inflammatory diseases using its proprietary small molecule nucleotide platform. Spring Bank designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. Spring Banks internally-developed programs are primarily designed to stimulate and/or dampen immune responses to achieve a desired therapeutic effect. Spring Bank is devoting its resources to advancing multiple programs in its STING (STimulator of INterferon Genes) product portfolio, including its STING agonist clinical program in oncology, its STING antagonist compounds for inflammatory diseases, and its STING agonist antibody drug conjugate (ADC), program for oncology.
Until January 2020, Spring Bank had been developing inarigivir, an investigational orally-administered RIG-I agonist compound, as a potential treatment for chronic hepatitis B virus (HBV). In April 2019, Spring Bank launched two Phase 2 global trials (CATALYST 1 and CATALYST 2) examining the administration of inarigivir 400mg as monotherapy and co-administered with a nucleotide in naïve and virally suppressed chronic HBV patients.. On January 29, 2020, Spring Bank announced that it was terminating all clinical development of inarigivir due to the occurrence of unexpected serious adverse events, including one patient death, in its Phase 2b CATALYST 2 trial.
Following an extensive process of evaluating strategic alternatives for Spring Bank and identifying and reviewing potential candidates for a strategic acquisition or other transaction, on July 29, 2020, Spring Bank and F-star entered into the Exchange Agreement under which Spring Bank would acquire all outstanding F-star share capital. If the Exchange is completed, the business of F-star will continue as the business of the combined company, as described in the section titled F-star Business in this proxy statement/prospectus.
Spring Bank expects to devote significant time and resources to completion of the Exchange. However, there can be no assurance that such activities will result in the completion of the Exchange. Further, the completion of the Exchange ultimately may not deliver the anticipated benefits or enhance shareholder value.
If the Exchange is not completed, Spring Bank will reconsider its strategic alternatives and could pursue any one of the following courses of action if the Exchange with F-star is not completed:
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Continue its business as currently conducted. Spring Bank may choose to continue to conduct its business, including the continued development of its STING programs. |
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Pursue another strategic transaction. Spring Bank may resume its process of evaluating a potential strategic transaction. |
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Dissolve and liquidate its assets. If, for any reason, the Exchange does not close and the Spring Bank Board determines to sell or otherwise dispose of the various assets of Spring Bank, any remaining cash proceeds would be distributed to its stockholders. In that event, Spring Bank would be required to wind down its clinical trials, pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims, and there would be no assurances as to the amount or timing of available cash remaining to distribute to stockholders after paying the Spring Bank obligations and setting aside funds for reserves. |
Spring Banks Business and Programs
The pandemic caused by an outbreak of a new strain of coronavirus (the COVID-19 pandemic) that is affecting the U.S. and global economy and financial markets is also impacting Spring Banks employees, patients, communities and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact Spring Banks business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. Spring Banks management is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce. The paragraphs that describe the impacts of the COVID-19 pandemic on Spring Banks clinical and preclinical development programs.
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Spring Bank is developing novel treatments for diseases with high unmet need in the therapeutic fields of immuno-oncology and inflammation. Spring Banks internally-developed pipeline focuses on the STING pathway and includes its STING agonist, STING antagonist, and STING agonist ADC programs.
STING Agonist Program
Spring Bank is developing multiple STING agonist compounds as potential immunotherapeutic agents for the treatment of selected cancers. Immunotherapy has emerged in recent years as a transformative approach for the treatment of cancer. The induction of interferons and interferon-stimulated genes in tumor cells and within the tumor microenvironment has been shown to modulate the host-immune response and induce apoptosis of tumor cells. Activation of the STING pathway can result in the induction of cellular interferons and cytokines while promoting a strong anti-tumor response through the induction of innate and adaptive immune responses. Therapeutically targeting the STING pathway could turn an immunologically cold tumor into a hot one, making it more likely to respond to other forms of immunotherapy, such as immune checkpoint inhibitors.
Spring Bank is developing its lead STING agonist product candidate, SB 11285, as a next-generation immunotherapeutic cyclic dinucleotide for the treatment of selected cancers. In Spring Banks preclinical studies in multiple tumor-derived cell lines, Spring Bank has observed SB 11285 to cause the induction of cytokines consistent with engagement of the STING target, as well as cell death and apoptosis. Based on Spring Banks preclinical studies performed to date, SB 11285 has demonstrated efficacy in multiple rodent tumor models when administered intravenously or intratumorally. Spring Bank believes that SB 11285 may be administered clinically by multiple routes of administration, enabling SB 11285 to target a variety of tumors at various anatomic sites. Furthermore, SB 11285 has the potential to be used in combination with other therapeutic modalities to enhance efficacy.
SB 11285 is currently being evaluated as an intravenously (IV)-administered monotherapy in a Phase 1a/1b multicenter, dose escalation clinical trial in patients with advanced solid tumors. Phase 1a of this trial is a dose-escalation study with IV SB 11285 monotherapy which allows combination with a checkpoint inhibitor after the completion of the first two cohorts of the trial. Phase 1b of this trial is designed to explore IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in tumor types expected to be responsive to immunotherapy. This trial is designed to determine a recommended Phase 2 dose in combination with a checkpoint inhibitor. In February 2020, Spring Bank entered into a clinical collaboration with Roche for the use of Roches PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in the combination cohorts of this trial.
Spring Bank initiated dosing in the initial monotherapy cohort of this Phase 1 trial in the fourth quarter of 2019 and has since completed two additional dose-escalating monotherapy cohorts. In August 2020, Spring Bank initiated the first combination cohort of this Phase 1 trial examining the co-administration of SB 11285 and atezolizumab. Although several of the institutions involved in the conduct of this trial have suspended patient enrollment in all of their clinical trials due to the COVID-19 pandemic, Spring Bank has been able to continue dosing patients in this trial at two key sites and completed the dosing of patients in the third cohort in August 2020. Depending on whether Spring Bank is able to continue enrolling and dosing patients in this Phase 1 trial, it plans to complete the fourth monotherapy cohort by the end of the third or early fourth quarter of 2020. Spring Bank anticipates that it will announce monotherapy data in the fourth quarter of 2020 and hopes to generate sufficient data from the Phase 1a/1b IV STING agonist program by the end of the first half of 2021 to enable advancement into a Phase 2 clinical trial. While Spring Bank currently anticipates this Phase 1 trial will remain open and currently enrolled patients will continue on study, all clinical sites activated for the study may determine to stop enrolling and/or dosing patients as a result of the impact of the COVID-19 pandemic, which has the potential to impact both the advancement into combination cohorts and the availability of data in 2020 and the first half of 2021.
STING Antagonist Program
Spring Bank is exploring the use of its novel STING antagonist compounds for the treatment of certain autoimmune and inflammatory diseases where the STING pathway is involved. Spring Banks STING antagonists are selectively designed to block aberrant activation of the STING pathway, which contributes to the causes of certain autoimmune and inflammatory diseases, including STING-associated vasculopathy with onset
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in infancy (SAVI), systemic lupus erythematosus (SLE) and other proinflammatory-mediated diseases. Spring Bank has developed and intend to continue to develop several potent inhibitors with favorable drug-like properties to allow for once a day dosing by the oral route of administration.
In July 2019, at the Autoimmunity Conference organized by the Federation of American Societies for Experimental Biology, Spring Bank presented preclinical data from a novel STING antagonist compound, which showed potent inhibition of interferon-beta and other pro-inflammatory cytokines in in vitro models containing wild type or mutant STING. In vivo administration of one of the candidate compounds antagonized STING-specific mediated interferon and cytokine production in the blood, spleen and liver in mice, suggesting the potential that this compound may have for therapeutic applications in interferonopathies, as well as in autoimmune and inflammatory diseases. Furthermore, in August 2019, Spring Bank entered into a research agreement with the University of Texas Southwestern Medical School to evaluate its small molecule STING antagonist compounds in relevant disease models.
Spring Bank plans to initiate IND-enabling activities for its lead, orally-available STING antagonist product candidate, SB 11736, in early 2021.
STING Agonist ADC Program
ADCs represent a novel platform to enable the targeted delivery of payload molecules. Conjugation of a payload molecule to an antibody that has its own efficacy profile could allow for a single drug with enhanced potency and safety compared to either mechanism alone. Spring Bank believes the chemistry used to develop its STING agonists is differentiated from first generation STING agonists because preclinical studies have shown that its molecules allow for site-specific conjugation to other therapeutic modalities, including antibodies, to form ADCs. Spring Banks STING agonists, in combination with an antibody to form an ADC, could provide targeted delivery to the tumor site to better achieve anti-tumor efficacy.
Potential COVID-19 Therapeutic Applications
In April 2020, Spring Bank announced that it is exploring programs and collaborations to study its portfolio of RIG-I agonist and STING agonist compounds as potential therapeutics and vaccine adjuvants for SARS-CoV-2, the virus responsible for COVID-19. Spring Bank is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to examine multiple compounds from its RIG-I agonist and STING agonist portfolio in the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) assay and the SARS-CoV-2 antiviral assay. Spring Bank is also pursuing the inclusion of inarigivir, a RIG-I agonist, as an adjuvant therapy in ongoing clinical trials involving Bacille Calmette-Guerin (BCG) vaccines against SARS-CoV-2.
SB 11285 Phase 1a/1b Clinical Trial
Spring Bank is developing its lead STING agonist product candidate, SB 11285, as a next-generation immunotherapeutic agent for the treatment of selected cancers. Spring Bank believes that SB 11285 may be administered clinically by multiple routes of administration, enabling SB 11285 to target a variety of tumors at various anatomic sites.
The objectives of Spring Banks Phase 1a/1b clinical trial include determining a safe and pharmacodynamically active dose of intravenously-administered SB 11285 and preliminary assessment of antitumor activity/efficacy. The Phase 1a dose escalation study is designed to evaluate ascending doses of SB 11285 with respect to dose-limiting toxicities, maximum tolerated dose, and to determine a recommended phase 2 dose as well as the pharmacokinetic/pharmacodynamic profile as monotherapy and in combination with a checkpoint inhibitor. The expansion cohorts of the trial are designed to explore signs of efficacy in pre-specified tumor types using the recommended phase 2 dose of SB 11285 in combination with a checkpoint inhibitor and to assess the safety profile of the combination in treated patients. Spring Bank expects the tumors that Spring Bank intends to explore to be responsive to immunotherapy.
The American Cancer Society projected that in the United States over 1.75 million new cases of cancer were to be diagnosed and over 600,000 people would die from the disease in 2019, highlighting the significant medical
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need in patients with cancer. Current standard of care approaches to treating patients with cancer include several different modalities, such as surgery, radiotherapy, cytotoxic chemotherapy and immunotherapy as single modalities or as combination therapies. In recent years, immunotherapy or therapeutic agents designed to engage the immune system, such as checkpoint inhibitors (including PD-1/PD-L1, and CTLA4) have shown significant clinical responses in the management and treatment of solid tumors. The efficacy of checkpoint inhibitors illustrates that cancer immunotherapy can be successfully implemented in routine clinical practice. However, a substantial proportion of patients do not achieve significant clinical benefit from treatment with checkpoint inhibitors, underscoring the need to identify additional strategies, which may include a STING agonist, to treat cancer. Spring Bank has shown that after administration of its STING agonist in the preclinical setting, there is up-regulation of the PD-1 molecule, which Spring Bank believes underscores the potential utility of its approach to employ the activity of a PD-1 checkpoint inhibitor.
Trial Design
Spring Bank is conducting a Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation and cohort expansion study to examine the dose-limiting toxicities, maximum tolerated dose and recommended Phase 2 dose of SB 11285 administered as an IV infusion in patients with advanced solid tumors. Phase 1a of the study will assess the safety and tolerability of SB 11285 as monotherapy in eligible patients with any advanced solid tumors. Phase 1b will assess the safety and tolerability of SB 11285 in combination with a checkpoint inhibitor in patients with advanced solid tumors. Spring Bank anticipates that Phase 2 of this trial will further evaluate the combination of the recommended Phase 2 dose of SB 11285 and checkpoint inhibitor(s) in the following tumor type cohorts:
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Cohort A: Melanoma |
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Cohort B: Head and neck squamous cell carcinoma (HNSCC) |
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Cohort C: Tumors other than Cohort A and B (Naïve or relapsed refractory to anti PD-1/PD-L1) |
In Phase 1a of the trial, monotherapy dose escalation, patients who meet eligibility criteria receive IV SB 11285 as monotherapy weekly on Days 1, 8, 15, and 22 of repeated 28-day cycles in escalating doses. Once the second dose level of the Phase 1a monotherapy cohort has been evaluated by the Safety Review Committee (SRC) and has been found to be well-tolerated to escalate to the third dose level, Spring Bank will begin enrollment in the first dose level of the Phase 1b portion of the trial, involving combination dose escalation (SB 11285 in combination with a checkpoint inhibitor).
Both Phases 1a and 1b of the study will use a standard 3+3 dose-escalation design with the dose escalated in successive cohorts of 3 to 6 patients each within each cohort in an open-label fashion. Once a cohort has been deemed well-tolerated and the study is cleared by the SRC to proceed with the next cohort, additional enrollment into previously cleared cohorts may be performed for further characterization of pharmacokinetics and pharmacodynamics, up to 6 patients per cohort.
Rationale for Selection of Tumors in Expansion Cohorts
The second part of the Phase 1 trial is designed to explore antitumor activity in pre-specified tumor types, confirm the safety and tolerability of SB 11285 in combination with a checkpoint inhibitor, and confirm the recommended Phase 2 dose. The pre-specified tumor type cohorts, melanoma and HNSCC, are designed to provide an initial understanding of the combination of SB 11285 and a checkpoint inhibitor and the associated level of antitumor activity in relapsed/refractory patients. The activity of SB 11285 with a checkpoint inhibitor will also be assessed in patients in a third cohort with other tumor types which are relapsed/refractory or naïve to PD-/PD-L1. Any demonstration of clinical activity in these patients could also enable an exploration of patient characteristics that may influence activity, as well as support subsequent studies combining SB 11285 with other therapies.
Additional Clinical Development Plans
After completion of Spring Banks initial Phase 1 studies and subject to obtaining additional financing, Spring Bank plans to develop intravenously administered SB 11285 in combination with different oncology treatment modalities with further exploration of different routes of administration and with other treatment
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modalities in various tumor types. Spring Bank plans to explore intratumoral administration of SB 11285 in hepatocellular carcinoma (HCC). With respect to other treatment modalities, Spring Bank intends to explore the combination of SB 11285 with radiation, chemotherapy, complimentary immune-mediated mechanisms and precision therapies.
Intellectual Property
Spring Banks success will depend upon Spring Banks ability, and upon the ability of any future collaborators of Spring Bank, to obtain and maintain intellectual property protection in the United States and other key pharmaceutical markets around the world for its product candidates and technologies, defend and enforce its intellectual property rights, preserve the confidentiality of its trade secrets and operate without infringing valid and enforceable intellectual property rights of others. Spring Bank has sought, and plan to continue to seek, patent protection in the United States and other key pharmaceutical markets, that is intended to cover the composition of matter of its product candidates, their methods of use, related technologies and other inventions that are important to its business. In addition to patent protection, Spring Bank also relies on trade secrets to protect aspects of its business that are not amenable to, or that Spring Bank does not consider appropriate for, patent protection.
Spring Bank has devoted considerable effort and resources to build a substantial patent estate designed to provide multiple levels of protection for its product candidates. As of September 15, 2020, Spring Bank owned 14 patent families relating to the STING pathway. Spring Bank holds 30 U.S. provisional patent applications, five U.S. nonprovisional patent applications, 11 international (PCT) patent applications, 41 foreign patent applications, and two foreign patents, which include claims relating to compositions of matter and various methods of using its STING pathway technology. If any of these patent applications are issued, the patents would be expected to begin to expire in 2037, without considering any potential patent term adjustments or extensions.
In each case, Spring Bank owns or holds the exclusive license to the foregoing patents and patent applications. Spring Bank is not aware of any contested proceeding or third-party claims that cover any of its patents or patent applications.
The actual protection afforded by a particular patent varies from country to country and depends upon many factors, including the type of patent, the scope of its coverage and the availability of legal remedies in the country in which it issued.
The term of individual patents depends upon the legal term of patents in the countries in which they are obtained. In most countries in which Spring Bank files, the patent term is 20 years from the earliest date of filing a non-provisional patent application.
In the United States, the term of a patent covering an FDA-approved drug may be eligible for a patent term extension under the Hatch-Waxman Act as compensation for the loss of patent term during the FDA regulatory review process. The period of extension may be up to five years beyond the expiration of the patent but cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent among those eligible for an extension may be extended. Similar provisions are available in Europe and in certain other jurisdictions to extend the term of a patent that covers an approved drug. If Spring Banks product candidates receives FDA approval, Spring Bank intends to apply for patent term extensions, if available, to extend the term of patents that cover the approved product candidates. Spring Bank also intends to seek patent term extensions in any jurisdictions where they are available, however, there is no guarantee that the applicable authorities, including the FDA, will agree with its assessment of whether such extensions should be granted, and even if granted, the length of such extensions.
Manufacturing
Spring Bank does not currently own or operate manufacturing facilities for production of clinical or commercial quantities of any of its compounds or their components. To date, Spring Bank has only manufactured supplies of drug substance for use in its preclinical studies at its own facilities and have contracted with several third-party contract manufacturing organizations for the supply of drug substance and finished product to meet its needs for preclinical testing, including toxicology studies and clinical trials. Spring Bank believes that each of
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these suppliers has sufficient capacity to meet its needs, and that adequate alternative sources exist. Spring Bank typically orders drug substance and clinical trial supplies on a work order basis and do not enter into long-term dedicated capacity or minimum supply arrangements. However, there is a risk that, if supplies are interrupted, it would materially harm its business.
In the ordinary course of its business, Spring Bank explores additional sources of supply and believe that Spring Bank will have additional manufacturer (s) in place in the future for the manufacture of clinical drug supply. If the supply of drug substance is insufficient to complete its trials or Spring Bank is unable to obtain alternative sources of supply on favorable terms, on a timely basis or at all, its business may be adversely affected. Spring Bank expects to continue to rely on third-party contract manufacturing organizations for the supply of drug substance and clinical trial supplies for its compounds for the foreseeable future.
Manufacturing is subject to extensive regulation that imposes various procedural and documentation requirements that govern record keeping, manufacturing processes and controls, personnel, quality control and quality assurance. Spring Bank is reliant on its contract manufacturers to comply with these requirements, including manufacturing its compounds for use in clinical trials under current Good Manufacturing Practice (cGMP), conditions. cGMP is a regulatory standard for the production of pharmaceuticals intended for use in humans.
Sales and Marketing
Given its stage of development, Spring Bank has not yet established a commercial organization or distribution capabilities, nor have Spring Bank entered into any collaboration or co-promotion arrangements. Spring Bank may build focused capabilities in the United States to commercialize development programs where Spring Bank believes that the medical specialists for the indications are sufficiently concentrated to allow Spring Bank to promote the product effectively with a targeted sales team. Spring Bank could engage in strategic relationships with biotechnology and pharmaceutical companies to accelerate the development of its programs and/or realize greater value for its shareholders due to faster access to broader geographic markets or the pursuit of broader patient populations or indications.
Competition
The development and commercialization of new drug products is highly competitive and characterized by rapid and substantial technological development and product innovations. Spring Bank faces competition with respect to its current product candidates and will face competition with respect to any product candidates that Spring Bank may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide.
Spring Banks STING agonist program will face significant competition from companies in the immuno-oncology area. Numerous companies are developing STING agonists. Below is a selected listing of companies that Spring Bank is aware of that are developing STING agonists in different phases of clinical development.
Compound |
Company |
Phase |
Delivery |
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ADU-S100 | Aduro Biotech | Phase I | Intratumoral | |||
MK-1454 | Merck | Phase I | Intratumoral | |||
MK-2118 | Merck | Phase I | Intratumoral | |||
SYMB1891 | Synlogic, Inc. | Phase I | Intratumoral | |||
BMS-986301 | Bristol-Meyers Squibb | Phase I | Intratumoral or Intramuscular | |||
GSK532 | GlaxoSmithKline | Phase I | Intravenous | |||
ExoSTING | Codiak Biosciences | Preclinical | Intratumoral | |||
E7766 | Eisai Co., Ltd. | Preclinical | Intratumoral | |||
CRD5500 | Curadev Pharma | Preclinical | Intratumoral or antibody conjugated | |||
TTI-10001 | Trillium Therapeutics | Preclinical | Intratumoral | |||
SR-8314 | Stingray Therapeutics | Preclinical | Intraperitoneal |
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Spring Bank is also aware that some of these same companies, as well as others, are pursuing the development of STING antagonist candidates for treatment of autoimmune and inflammatory diseases.
Many of the companies against which Spring Bank is competing or against which it may compete in the future have significantly greater financial resources, established presence in the market and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than Spring Bank does. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of its competitors.
Spring Bank competes with the biotechnology companies listed above and others in recruiting and retaining qualified scientific, sales and marketing and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, its programs.
The key competitive factors affecting the success of SB 11285 and any other product candidates that Spring Bank develops, if approved, are likely to be their efficacy, safety, convenience, price and the availability of reimbursement from government and other third-party payors.
Spring Banks commercial opportunity could be reduced or eliminated if its competitors develop and commercialize products that are more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that Spring Bank may develop. Spring Banks competitors also may obtain FDA or other regulatory approval for their products more rapidly than Spring Bank may obtain approval for itself, which could result in its competitors establishing a strong market position before Spring Bank is able to enter the market. In addition, Spring Banks ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of lower cost products.
Government Regulation and Product Approvals
Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union (EU) extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting and import and export of pharmaceutical products. The processes for obtaining marketing approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.
Review and Approval of Drugs in the United States
In the United States, the FDA approves and regulates drugs under the FDCA, and implementing regulations. The failure to comply with requirements under the FDCA and other applicable laws at any time during the product development process, approval process or after approval may subject an applicant and/or sponsor to a variety of administrative or judicial sanctions, including refusal by the FDA to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits or civil or criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities.
An applicant seeking approval to market and distribute a new drug product in the United States must typically undertake the following:
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completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDAs good laboratory practice (GLP) regulations; |
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submission to the FDA of an IND, which must take effect before human clinical trials may begin; |
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approval by an independent institutional review board (IRB) representing each clinical site before each clinical trial may be initiated; |
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performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (GCP) to establish the safety and efficacy of the proposed drug product for each indication; |
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preparation and submission to the FDA of a new drug application (NDA) requesting marketing for one or more proposed indications; |
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review by an FDA advisory committee, where appropriate or if applicable; |
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satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the products identity, strength, quality and purity; |
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satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data; |
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payment of user fees and securing FDA approval of the NDA; and |
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compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (REMS), and the potential requirement to conduct post-approval studies. |
Preclinical Studies
Before an applicant begins testing a compound with potential therapeutic value in humans, the drug candidate enters the preclinical testing stage. Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as in vitro and animal studies to assess the potential safety and activity of the drug for initial testing in humans and to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations and requirements, including GLP regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among other things, are submitted to the FDA as part of an IND. Some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, may continue after the IND is submitted.
Human Clinical Trials in Support of an NDA
Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed consent in writing before their participation in any clinical trial. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to a proposed clinical trial and places the trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA can place an IND on clinical hold at any point in development, and depending upon the scope of the hold, clinical trial(s) may not restart until resolution of the outstanding concerns to the FDAs satisfaction. For additional information on clinical trials, see the section titled F-star BusinessGovernmental Regulation and Product Approval of this proxy statement/prospectus.
A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND. When a foreign clinical study is conducted under an IND, all FDA IND requirements must be met unless waived. When the foreign clinical study is not conducted under an IND, the sponsor must ensure that the study complies with certain FDA regulatory requirements in order to use the study as support for an IND or application for marketing approval. Specifically, on April 28, 2008, the FDA amended its regulations governing the acceptance of foreign clinical studies not conducted under an investigational new drug application as support for an IND or a NDA. The final rule provides that such studies must be conducted in accordance with GCP, including review and approval by an independent ethics committee and informed consent from subjects. The GCP requirements in the final rule encompass both ethical and data integrity standards for clinical studies. The FDAs regulations are intended to help ensure the protection of human subjects enrolled in non-IND foreign clinical studies, as well as the quality and integrity of the resulting data. They further help ensure that non-IND foreign studies are conducted in a manner comparable to that required for IND studies.
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Concurrent with clinical trials, companies often complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things, must develop methods for testing the identity, strength, quality, purity and potency of the final drug. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life.
Review of an NDA by the FDA
Assuming successful completion of required clinical testing and other requirements, the results of the preclinical studies and clinical trials, together with detailed information relating to the products chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the drug product for one or more indications. Under federal law, the submission of most NDAs is additionally subject to an application user fee, currently exceeding $2.3 million, and the sponsor of an approved NDA is subject to annual product and establishment user fees, currently exceeding $114,000 per product and $585,000 per establishment. These fees typically increase annually. Certain exceptions and waivers are available for some of these fees, such as an exception from the application fee for drugs with orphan designation and a waiver for certain small businesses.
The FDA conducts a preliminary review of an NDA generally within 60 calendar days of its receipt and strives to inform the sponsor by the 74th day after the FDAs receipt of the submission to determine whether the application is sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA has agreed to specified performance goals in the review process of NDAs. Under that agreement, 90% of applications seeking approval of New Molecular Entities (NMEs), are meant to be reviewed within ten months from the date on which FDA accepts the NDA for filing, and 90% of applications for NMEs that have been designated for Priority Review are meant to be reviewed within six months of the filing date. For applications seeking approval of drugs that are not NMEs, the ten-month and six-month review periods run from the date that FDA receives the application. The FDA may extend the review process and the Prescription Drug User Fee Act goal date for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is or will be manufactured. These pre-approval inspections may cover all facilities associated with an NDA submission, including drug component manufacturing (e.g., active pharmaceutical ingredients), finished drug product manufacturing and control testing laboratories. The FDA will not approve an application unless it determines that the manufacturing processes and facilities comply with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.
In addition, as a condition of approval, the FDA may require an applicant to develop a REMS. REMS use risk minimization strategies beyond the professional labeling to ensure that the benefits of the product outweigh the potential risks. To determine whether a REMS is needed, the FDA will consider the size of the population likely to use the product, seriousness of the disease, expected benefit of the product, expected duration of treatment, seriousness of known or potential adverse events and whether the product is an NME. REMS can include medication guides, physician communication plans for healthcare professionals and elements to assure safe use (ETASU). ETASU may include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and using of patient registries. The FDA may require a REMS before approval or post-approval if it becomes aware of a serious risk associated with use of the product. The requirement for a REMS can materially affect the potential market and profitability of a product.
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The FDA is required to refer an application for a novel drug to an advisory committee or explain why such referral was not made. Typically, an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Fast Track, Breakthrough Therapy and Priority Review Designations
The FDA is authorized to designate certain products for expedited review if the product is intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs are Fast Track Designation, Breakthrough Therapy Designation and Priority Review Designation.
Specifically, the FDA may designate a product for Fast Track review if the product is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. For Fast Track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a Fast Track products application before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective. The sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable user fees. However, the FDAs time period goal for reviewing a Fast Track application does not begin until the last section of the application is submitted. In addition, the FDA may withdraw the Fast Track Designation if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
Second, in 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). This law established a new regulatory scheme allowing for expedited review of products designated as Breakthrough Therapies. A product may be designated as a Breakthrough Therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The FDA may take certain actions with respect to Breakthrough Therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials in an efficient manner.
Third, the FDA may designate a product for priority review if it is a product designed to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-by-case basis, whether the proposed product represents a significant improvement when compared with other available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes and evidence of safety and effectiveness in a new subpopulation. A Priority Review Designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDAs goal for taking action on a marketing application from ten months to six months.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. Furthermore, fast track designation, breakthrough therapy designation and priority review do not change the standards for approval and may not ultimately expedite the development or approval process.
Accelerated Approval Pathway
The FDA may grant accelerated approval to a product for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments based upon a determination that
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the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality (IMM), and that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. Products granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.
For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a product, such as an effect on IMM. The FDA has limited experience with accelerated approvals based on intermediate clinical endpoints, but has indicated that such endpoints generally may support accelerated approval where the therapeutic effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic effect is reasonably likely to predict the ultimate clinical benefit of a product.
The accelerated approval pathway is most often used in settings in which the course of a disease is long, and an extended period of time is required to measure the intended clinical benefit of a product, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Thus, accelerated approval has been used extensively in the development and approval of products for treatment of a variety of cancers in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large trials to demonstrate a clinical or survival benefit.
The accelerated approval pathway is usually contingent on a sponsors agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the products clinical benefit. As a result, a product candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw the product from the market on an expedited basis. All promotional materials for product candidates approved under accelerated regulations are subject to prior review by the FDA.
The FDAs Decision on an NDA
Based on the FDAs evaluation of an NDA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the product with prescribing information for specific indications. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. If and when those deficiencies have been addressed to the FDAs satisfaction in a resubmission of an NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
If the FDA approves a product, it may limit the approved indications for use for the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess the drugs safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms, including REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance programs. After approval, many types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.
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Post-Approval Requirements
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.
In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:
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restrictions on the marketing or manufacturing of the product, suspension of the approval, or complete withdrawal of the product from the market or product recalls; |
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fines, warning letters or holds on post-approval clinical trials; |
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refusal of the FDA to approve pending NDAs or supplements to approved NDAs; |
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product seizure or detention, or refusal to permit the import or export of products; or |
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injunctions or the imposition of civil or criminal penalties. |
In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (PDMA), and its implementing regulations, as well as the Drug Supply Chain Security Act (DSCA), which regulate the distribution and tracing of prescription drugs and prescription drug samples at the federal level and set minimum standards for the regulation of drug distributors by the states. The PDMA, its implementing regulations and state laws limit the distribution of prescription pharmaceutical product samples, and the DSCA imposes requirements to ensure accountability in distribution and to identify and remove counterfeit and other illegitimate products from the market.
For additional information see the section titled F-star BusinessGovernment Regulation and Product Approval: U.S. Post-Approval Requirements of this proxy statement/prospectus.
Abbreviated New Drug Applications for Generic Drugs
In 1984, with passage of the Hatch-Waxman Amendments to the FDCA, Congress established an abbreviated regulatory scheme authorizing the FDA to approve generic drugs that are shown to contain the same active ingredients as, and to be bioequivalent to, drugs previously approved by the FDA pursuant to NDAs. To obtain approval of a generic drug, an applicant must submit an abbreviated new drug application (ANDA), to the agency. An ANDA is a comprehensive submission that contains, among other things, data and information pertaining to the active pharmaceutical ingredient, bioequivalence, drug product formulation, specifications and stability of the generic drug, as well as analytical methods, manufacturing process validation data and quality control procedures. ANDAs are abbreviated because they generally do not include preclinical and clinical data to demonstrate safety and effectiveness. Instead, in support of such applications, a generic manufacturer may rely on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference-listed drug (RLD).
Specifically, in order for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form, the strength of the
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drug and the conditions of use of the drug. At the same time, the FDA must also determine that the generic drug is bioequivalent to the innovator drug. Under the statute, a generic drug is bioequivalent to a RLD if the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug
Upon approval of an ANDA, the FDA indicates whether the generic product is therapeutically equivalent to the RLD in its publication Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the Orange Book. Physicians and pharmacists consider a therapeutic equivalent generic drug to be fully substitutable for the RLD. In addition, by operation of certain state laws and numerous health insurance programs, the FDAs designation of therapeutic equivalence often results in substitution of the generic drug without the knowledge or consent of either the prescribing physician or patient.
Under the Hatch-Waxman Amendments, the FDA may not approve an ANDA until any applicable period of non-patent exclusivity for the RLD has expired. The FDCA provides a period of five years of non-patent data exclusivity for a new drug containing a new chemical entity (NCE). For the purposes of this provision an NCE is a drug that contains no active moiety that has previously been approved by the FDA in any other NDA. An active moiety is the molecule or ion responsible for the physiological or pharmacological action of the drug substance. In cases where such NCE exclusivity has been granted, an ANDA may not be filed with the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification, in which case the applicant may submit its application four years following the original product approval.
The FDCA also provides for a period of three years of exclusivity if an NDA includes reports of one or more new clinical investigations, other than bioavailability or bioequivalence studies, that were conducted by or for the applicant and are essential to the approval of the application. This three-year exclusivity period often protects changes to a previously approved drug product, such as a new dosage form, route of administration, combination or indication. Three-year exclusivity would be available for a drug product that contains a previously approved active moiety, provided the statutory requirement for a new clinical investigation is satisfied. Unlike five-year NCE exclusivity, an award of three-year exclusivity does not block the FDA from accepting ANDAs seeking approval for generic versions of the drug as of the date of approval of the original drug product. The FDA typically makes decisions about awards of data exclusivity shortly before a product is approved.
Pediatric Studies and Exclusivity
Under the Pediatric Research Equity Act (PREA), an NDA or supplement thereto must contain data that are adequate to assess the safety and effectiveness of the drug product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. With enactment of the FDASIA in 2012, sponsors must also submit pediatric study plans prior to the assessment of data. FDASIA sets forth the specific timing of the submission of the pediatric study plan. Those plans must contain an outline of the proposed pediatric study or studies the applicant plans to conduct, including study objectives and design, any deferral or waiver requests and any other information required by regulation. The applicant, the FDA and the FDAs internal review committee must then review the information submitted, consult with each other and agree upon a final plan. The FDA or the applicant may request an amendment to the plan at any time.
The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Additional requirements and procedures relating to deferral requests and requests for extension of deferrals are contained in FDASIA. Unless and until the FDA promulgates a regulation stating otherwise, the pediatric data requirements do not apply to products with orphan designation.
Pediatric exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity, including the non-patent and orphan exclusivity. This six-month exclusivity may be granted if an NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such
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data. The data do not need to show the product to be effective in the pediatric population studied. If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application. With regard to patents, the six-month pediatric exclusivity period will not attach to any patents for which an ANDA or 505(b)(2) applicant submitted a paragraph IV patent certification, unless the NDA sponsor or patent owner first obtains a court determination that the patent if valid and infringed by the proposed product.
Orphan Drug Designation and Exclusivity
Under the Orphan Drug Act, the FDA may designate a drug product as an orphan drug if it is intended to treat a rare disease or condition, generally meaning that it affects fewer than 200,000 individuals in the United States, or more in cases in which there is no reasonable expectation that the cost of developing and making a drug product available in the United States for treatment of the disease or condition will be recovered from sales of the product. A company must request orphan drug designation before submitting an NDA for the drug and rare disease or condition. If the request is granted, the FDA will disclose the identity of the therapeutic agent and its potential use. Orphan drug designation does not shorten the Prescription Drug User Fee Act (PDUFA) goal dates for the regulatory review and approval process, although it does convey certain advantages such as tax benefits and exemption from the PDUFA application fee.
If a product with orphan designation receives the first FDA approval for the disease or condition for which it has such designation or for a select indication or use within the rare disease or condition for which it was designated, the product generally will receive orphan drug exclusivity. Orphan drug exclusivity means that the FDA may not approve another sponsors marketing application for the same drug for the same indication for seven years, except in certain limited circumstances. Orphan drug exclusivity does not block the approval of a different drug for the same rare disease or condition, nor does it block the approval of the same drug for different indications. If a drug designated as an orphan drug ultimately receives marketing approval for an indication broader than what was designated in its orphan drug application, it may not be entitled to exclusivity. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same drug for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand.
Patent Term Restoration and Extension
A patent claiming a new drug product may be eligible for a limited patent term extension, also known as patent term restoration, under the Hatch-Waxman Act, which permits a patent restoration of up to five years for patent term lost during product development and the FDA regulatory review. Patent term extension is generally available only for drug products whose active ingredient has not previously been approved by the FDA. The restoration period granted is typically one-half the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the ultimate approval date. Patent term extension cannot be used to extend the remaining term of a patent past a total of 14 years from the products approval date. Only one patent applicable to an approved drug product is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent in question. A patent that covers multiple drugs for which approval is sought can only be extended in connection with one of the approvals. The United States PTO reviews and approves the application for any patent term extension in consultation with the FDA.
Review and Approval of Drugs Outside the United States
In addition to regulations in the United States, a manufacturer is subject to a variety of regulations in foreign jurisdictions to the extent they choose to sell any drug products outside the United States. Even if a manufacturer obtains FDA approval of a product candidate, it must still obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those
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countries. To obtain regulatory approval of an investigational drug or biological product in the EEA a manufacturer must submit a marketing authorization application to the European Commission and EU Member State Competent Authorities. For other countries outside of the EU, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, clinical trials are to be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
Clinical Trial Approval in the EU
Pursuant to the currently applicable Clinical Trials Directive 2001/20/EC and the Directive 2005/28/EC on GCP, an applicant must obtain the approval from the competent national authority of the EU Member State in which the clinical trial is to be conducted. If the clinical trial is conducted in different EU Member States, the competent authorities in each of these EU Member States must provide their approval for the conduct of the clinical trial. Furthermore, the applicant may only start a clinical trial at a specific study site after the competent ethics committee has issued a favorable opinion.
In April 2014, the EU adopted a new Clinical Trials Regulation (EU) No 536/2014, which is set to replace the current Clinical Trials Directive 2001/20/EC. The new Clinical Trials Regulation will be directly applicable in and binding in all EU Member States without the need for any national implementing legislation. It will overhaul the current system of approvals for clinical trials in the EU. Specifically, the new legislation aims at simplifying and streamlining the approval of clinical trials in the EU. Under the new coordinated procedure for the approval of clinical trials, the sponsor of a clinical trial will be required to submit a single application for approval of a clinical trial to a reporting EU Member State (RMS) through an EU Portal. The submission procedure will be the same irrespective of whether the clinical trial is to be conducted in a single EU Member State or in more than one EU Member State. The Clinical Trials Regulation also aims to streamline and simplify the rules on safety reporting for clinical trials.
Marketing Authorization
In the EEA, medicinal products can only be commercialized after obtaining a Marketing Authorization (MA).
There are two types of MAs:
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Community MAs, which are issued by the European Commission through the Centralized Procedure, providing for the grant of a single marketing authorization following a favorable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the EMA and which is valid throughout the entire territory of the European Economic Area (EEA). The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products and medicinal products indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU. Under the Centralized Procedure, the maximum timeframe for the evaluation of an MA application is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP). Accelerated evaluation might be granted by the CHMP in exceptional cases, when the authorization of a medicinal product is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. Under the accelerated procedure the standard 210-day review period is reduced to 150 days. |
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National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member States through the Mutual |
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Recognition Procedure. If the product has not received a National MA in any Member State at the time of application, it can be approved simultaneously in various Member States through the Decentralized Procedure. This application is identical to the application that would be submitted to the EMA for authorization through the centralized procedure. The reference EU Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting assessment report is submitted to the concerned EU Member States who, within 90 days of receipt must decide whether to approve the assessment report and related materials. If a concerned EU Member State cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the European Commission, whose decision is binding on all EU Member States. |
An MA may be granted only to an applicant established in the EU. Regulation No. 1901/2006 provides that prior to obtaining an MA in the EU, an applicant must demonstrate compliance with all measures included in a Pediatric Investigation Plan (PIP), approved by the Pediatric Committee of the EMA, covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, a class waiver or a deferral for one or more of the measures included in the PIP.
Regulatory Data Exclusivity in the EU
In the EU, innovative medicinal products authorized in the EU on the basis of a full MA application (as opposed to an application for an MA that relies on data available in the MA dossier for another, previously approved, medicinal product) are entitled to eight years of data exclusivity. During this period, applicants for authorization of generics of these innovative products cannot rely on data contained in the MA dossier submitted for the innovative medicinal product. During an additional two-year period of market exclusivity, a generic MA application can be submitted, and the innovators data may be referenced, but no generic medicinal product can be marketed until the expiration of the market exclusivity. The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to authorization, is held to bring a significant clinical benefit in comparison with existing therapies. Even if a compound is considered to be a new chemical entity so that the innovator gains the prescribed period of data exclusivity, another company may market another version of the product if such company obtained marketing authorization based on an MA with a complete independent data package of pharmaceutical tests, preclinical tests and clinical trials.
Periods of Authorization and Renewals in the EU
An MA is valid for five years, in principle, and it may be renewed after five years based on a reevaluation of the risk-benefit balance by the EMA or by the competent authority of the relevant EU Member State. To that end, the MA holder must provide the EMA or the relevant competent authority of the EU Member State with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the MA was granted, at least six months before the MA ceases to be valid. Once renewed, the MA is valid for an unlimited period, unless the European Commission or the relevant competent authority of the EU Member State decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any MA that is not followed by the marketing of the medicinal product on the EU market (in the case of the centralized procedure) or on the market of the EU Member State which delivered the MA within three years after authorization ceases to be valid (the so-called subset clause).
Regulatory Requirements after Marketing Authorization
Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA and the competent authorities of the individual EU Member States both before and after grant of the manufacturing and marketing authorizations.
The holder of an EU MA for a medicinal product must also comply with EU pharmacovigilance legislation and its related regulations and guidelines, which entail many requirements for conducting pharmacovigilance, or the assessment and monitoring of the safety of medicinal products. These rules can impose on central marketing
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authorization holders for medicinal products the obligation to conduct a labor-intensive collection of data regarding the risks and benefits of marketed products and to engage in ongoing assessments of those risks and benefits, including the possible requirement to conduct additional clinical studies.
The manufacturing process for medicinal products in the EU is highly regulated and regulators may shut down manufacturing facilities that they believe do not comply with regulations. Manufacturing requires a manufacturing authorization, and the manufacturing authorization holder must comply with various requirements set out in the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice. These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical ingredients into the EU. Similarly, the distribution of medicinal products into and within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for distribution granted by the competent authorities of the EU Member States.
In the EU, the advertising and promotion of Spring Banks products are subject to EU Member States laws governing promotion of medicinal products, interactions with physicians, misleading and comparative advertising and unfair commercial practices. In addition, other legislation adopted by individual EU Member States may apply to the advertising and promotion of medicinal products. These laws require that promotional materials and advertising in relation to medicinal products comply with the products Summary of Product Characteristics, (SmPC), as approved by the competent authorities. Promotion of a medicinal product that does not comply with the SmPC is considered to constitute off-label promotion. The off-label promotion of medicinal products is prohibited in the EU. The applicable laws at EU level and in the individual EU Member States also prohibit the direct-to-consumer advertising of prescription-only medicinal products. These laws may further limit or restrict the advertising and promotion of Spring Banks products to the general public and may also impose limitations on Spring Banks promotional activities with healthcare professionals.
Orphan Drug Designation and Exclusivity in the EU
Regulation (EC) No 141/2000 and Regulation (EC) No. 847/2000 provide that a product can be designated as an orphan medicinal product by the European Commission if its sponsor can establish: that the product is intended for the diagnosis, prevention or treatment of (1) a life-threatening or chronically debilitating condition affecting not more than five in ten thousand persons in the EU when the application is made, or (2) a life-threatening, seriously debilitating or serious and chronic condition in the EU and that without incentives the medicinal product is unlikely to be developed. For either of these conditions, the applicant must demonstrate that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the EU or, if such method exists, the medicinal product will be of significant benefit to those affected by that condition. Once authorized, orphan medicinal products are entitled to ten years of market exclusivity in all EU Member States and in addition a range of other benefits during the development and regulatory review process including scientific assistance for study protocols, authorization through the centralized marketing authorization procedure covering all member countries and a reduction or elimination of registration and marketing authorization fees. However, an MA may be granted to a similar medicinal product with the same orphan indication during the ten-year period with the consent of the MA holder for the original orphan medicinal product or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities. An MA may also be granted to a similar medicinal product with the same orphan indication if this product is safer, more effective or otherwise clinically superior to the original orphan medicinal product. In addition, the period of market exclusivity may be reduced to six years if it can be demonstrated based on available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity.
Pharmaceutical Coverage, Pricing and Reimbursement
In the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all
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or part of the associated healthcare costs. Patients are unlikely to use Spring Banks products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of Spring Banks products. Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities. Even if Spring Banks product candidate is approved, sales of its products will depend, in part, on the extent to which third-party payors, including government health programs in the United States such as Medicare and Medicaid, commercial health insurers and managed care organizations, provide coverage, and establish adequate reimbursement levels for, such products. For additional information, see F-star BusinessGovernment Regulation and Product Approval: Coverage, Pricing, and Reimbursement of this proxy statement/prospectus.
Outside the United States, ensuring adequate coverage and payment for Spring Banks product candidates will face challenges. Pricing of prescription pharmaceuticals is subject to governmental control in many countries. Pricing negotiations with governmental authorities can extend well beyond the receipt of regulatory marketing approval for a product and may require Spring Bank to conduct a clinical trial that compares the cost effectiveness of its product candidate or products to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in Spring Banks commercialization efforts.
In the EU, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug candidate to currently available therapies or so-called health technology assessments, in order to obtain reimbursement or pricing approval. For example, the EU provides options for its member states to restrict the range of products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. EU member states may approve a specific price for a product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the product on the market. Other member states allow companies to fix their own prices for products but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. Recently, many countries in the EU have increased the amount of discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crises experienced by many countries in the EU. The downward pressure on healthcare costs in general, particularly prescription drugs, has become intense. As a result, increasingly high barriers are being erected to the entry of new products. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states, and parallel trade, i.e., arbitrage between low-priced and high-priced member states, can further reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Spring Banks products, if approved in those countries.
Healthcare Law and Regulation
Healthcare providers and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing approval. Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable fraud and abuse, anti-kickback, false claims laws, reporting of payments to physicians and teaching physicians and patient privacy laws and regulations and other healthcare laws and regulations that may constrain Spring Banks business and/or financial arrangements. Restrictions under applicable federal and state healthcare laws and regulations are detailed in the section entitled F-star BusinessGovernment Regulation and Product Approval: Anti-Kickback, False Claims, Physician Payments Sunshine and Other U.S. Healthcare Laws of this proxy statement/prospectus.
Healthcare Reform
A primary trend in the United States healthcare industry and elsewhere is cost containment. There have been a number of federal and state proposals during the last few years regarding the pricing of pharmaceutical and biopharmaceutical products, limiting coverage and reimbursement for drugs and other medical products, government control and other changes to the healthcare system in the United States.
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By way of example, the United States and state governments continue to propose and pass legislation designed to reduce the cost of healthcare. In March 2010, President Obama signed into law the PPACA, which, among other things, includes changes to the coverage and payment for products under government healthcare programs. Among the provisions of the PPACA of importance to Spring Banks potential drug candidates are:
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an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs, although this fee would not apply to sales of certain products approved exclusively for orphan indications; |
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expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturers Medicaid rebate liability; |
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expanded manufacturers rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of average manufacturer price, or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices and extending rebate liability to prescriptions for individuals enrolled in Medicare Advantage plans; |
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addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; |
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expanded the types of entities eligible for the 340B drug discount program; |
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established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers outpatient drugs to be covered under Medicare Part D; |
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research; |
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the Independent Payment Advisory Board (IPAB) which has authority to recommend certain changes to the Medicare program to reduce expenditures by the program that could result in reduced payments for prescription drugs. However, the IPAB implementation has been not been clearly defined. PPACA provided that under certain circumstances, IPAB recommendations will become law unless Congress enacts legislation that will achieve the same or greater Medicare cost savings; and |
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established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. Funding has been allocated to support the mission of the Center for Medicare and Medicaid Innovation from 2011 to 2019. |
For other legislative changes, see the section titled F-star Business: Government Regulations and Product Approval: Healthcare Reform of this proxy statement/prospectus. There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. Such reforms could have an adverse effect on anticipated revenues from product candidates that Spring Bank may successfully develop and for which it may obtain marketing approval and may affect its overall financial condition and ability to develop product candidates.
Employees
As of September 15, 2020, Spring Bank had 13 full-time permanent employees, of which seven work in administration and operations and six work in research and development. Seven of its 13 full-time permanent employees hold a Ph.D. or M.D. degree. Spring Bank has no collective bargaining agreements with its employees and has not experienced any work stoppages. Spring Bank considers its relations with its employees to be good.
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Properties
Spring Banks current operations are based in Hopkinton, Massachusetts. A description of the facilities Spring Bank leases as of September 15, 2020 is included in the table below.
Location |
Primary Use |
Approximate
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Lease
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Renewal Option |
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35 Parkwood Drive, Suite 210, Hopkinton, Massachusetts |
Corporate headquarters | 31,315 | October 2028 | One five-year term |
Legal Proceedings
As set forth below, certain Spring Bank stockholders have filed complaints against Spring Bank, the members of the Spring Bank Board and/or F-star relating to the Exchange and the registration statement filed in connection therewith.
On September 3, 2020, a Spring Bank stockholder filed a complaint in the United States District Court for the Southern District of New York (Lenthall v. Spring Bank Pharmaceuticals, Inc. et al, Case No. 1:20-cv-07219 (S.D.N.Y.)), against Spring Bank and the members of the Spring Bank Board of Directors (the individual defendants), alleging violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, and as against the individual defendants, alleging violations of Section 20(a) of the Exchange Act and of Delaware state law. The plaintiff alleges that the defendants made materially misleading disclosures in the registration statement, of which this proxy statement/prospectus forms a part, in connection with the proposed Exchange, by allegedly omitting material information with respect to (i) financial projections prepared by Spring Banks and F-stars management, (ii) Ladenburgs Opinion and (iii) any financial analyses conducted on Spring Bank. The plaintiff in Lenthall seeks declaratory and injunctive relief to enjoin the Exchange as well as damages and attorneys and experts fees.
On September 8, 2020, in the United States District Court for the District of Delaware, a purported class action (Adam Franchi v. Spring Bank Pharmaceuticals, Inc. et al, Case No. 1:20-cv-01198 (D. Del.)) was filed against Spring Bank, members of the Spring Bank Board of Directors and F-star, alleging violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, and as against the individual defendants, alleging violations of Section 20(a) of the Exchange Act. This complaint alleges that the defendants made materially misleading disclosures in the registration statement, of which this proxy statement/prospectus forms a part, in connection with the proposed Exchange, by allegedly omitting material information with respect to (i) financial projections prepared by Spring Banks and F-stars management, (ii) the confidentiality agreements entered into by Spring Bank prior to its engagement of Ladenburg, (iii) the process leading up to the execution of the Exchange Agreement and (iv) any financial analyses performed by Ladenburg. The plaintiff in Franchi seeks declaratory and injunctive relief to enjoin the Exchange; or in the event of consummation of the Exchange, rescissory damages against the defendants; filing by the defendants of a Registration Statement deemed not to be materially misleading by the plaintiff; and attorneys and experts fees.
On September 18, 2020, in the United States District Court for the Southern District of New York, another Spring Bank stockholder filed a complaint (Arshad v. Spring Bank Pharmaceuticals, Inc., et al., Case No. 1:20-cv-07723 (S.D.N.Y.)), against Spring Bank and the members of the Spring Bank Board of Directors, alleging violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, and as against the individual defendants, alleging violations of Section 20(a) of the Exchange Act. The plaintiff alleges that the defendants made materially misleading disclosures in the registration statement, of which this proxy statement/prospectus forms a part, in connection with the proposed Exchange, by allegedly omitting material information with respect to (i) financial projections prepared by Spring Banks and F-stars management, (ii) Ladenburgs Opinion and (iii) the process relating to the Exchange. The plaintiff in Arshad seeks declaratory and injunctive relief to enjoin the Exchange; or in the event of consummation of the Exchange,
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rescissory damages against the defendants; filing by the defendants of a Registration Statement deemed not to be materially misleading by the plaintiff; and attorneys and experts fees.
Each of the defendants believes that the complaints are without merit and intend to defend against them vigorously. There can be no assurance, however, that any defendant will be successful. At present, each defendant is unable to estimate potential losses, if any, related to the lawsuits.
From time to time, Spring Bank may become involved in legal proceedings arising in the ordinary course of its business. Spring Bank is not presently a party to any material litigation or, except as described above, to any litigation relating to the Exchange.
Corporate Information
Spring Bank was incorporated under the laws of the Commonwealth of Massachusetts as Spring Bank Technologies, Inc. on October 7, 2002. On May 12, 2008, Spring Bank filed a certificate of incorporation in the State of Delaware and changed its state of incorporation to Delaware and its name to Spring Bank Pharmaceuticals, Inc. Its principal executive offices are located at 35 Parkwood Drive, Suite 210, Hopkinton, MA 01748 and its telephone number is (508) 473-5993. Its website address is www.springbankpharm.com. The information contained in, or accessible through, its website does not constitute a part of this proxy statement/prospectus.
Available Information
You may obtain free copies of Spring Banks Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, as soon as reasonably practicable after they are electronically filed or furnished to the Securities and Exchange Commission,( the SEC) on Spring Banks website at www.springbankpharm.com or by contacting Spring Bank at (508) 473-5993. The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. The inclusion of any website address in this proxy statement/prospectus is an inactive textual reference only, and information contained on or accessible through these websites is not a part of this proxy.
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Overview
F-star is a clinical-stage immuno-oncology company focused on transforming the lives of patients with cancer through the development of F-stars innovative tetravalent mAb2 bispecific antibodies. With four distinct binding sites in a natural human antibody format, F-star believes its proprietary technology will overcome many of the challenges facing current immuno-oncology therapies, because of the strong pharmacology enabled by tetravalent bispecific binding. F-stars vision is to transform the treatment of cancer through the development of clinically differentiated, different from other therapeutic agents, and well tolerated, as in safe to administer to patients, mAb2 bispecific antibodies, which are designed to address multiple immune evasion pathways that limit the effect of current immuno-oncology therapies.
F-stars most advanced product candidate, FS118, is currently being evaluated in a Phase 1 clinical trial in heavily pre-treated patients with advanced cancer, having received a median of six lines of such treatments, and who have failed PD-1/PD-L1 therapy. FS118 is a tetravalent mAb2 bispecific antibody targeting two receptors, PD-L1 and LAG-3, both of which are established pivotal targets in immuno-oncology. Preliminary data from 43 patients in this trial showed that administration of FS118 was well-tolerated. In addition, a disease control rate, defined as either a complete response, partial response or stable disease, of 54% was observed in 20 of 37 evaluable patients, and long-term (greater than six months) disease control was observed in six of these patients. F-star expects to report additional results from this Phase 1 trial in the fourth quarter of 2020 and to initiate a proof of concept trial in PD-1 resistant head and neck cancer patients in the first half of 2021.
On January 27, 2020, the U.S. Food and Drug Administration (the FDA), accepted the Investigational New Drug (the IND) application of product candidate FS120. FS120 is a first-in-class dual agonist bispecific antibody, an antibody that stimulates two immune activating pathways, which F-star believes has the potential to overcome cancer resistance by simultaneously targeting CD137 (4-1BB) and OX40, two receptors present on the surface of tumor-infiltrating lymphocytes. Unlike checkpoint inhibitors, the mechanism of action of FS120 is designed to trigger a positive signal that enhances multiple mechanisms essential for killing tumor cells. FS120 has a natural antibody format. It is engineered to abrogate Fc gamma receptor binding and effector activity, providing increased specificity and, F-star believes, superior performance while reducing toxicity through conditional, crosslink-dependent activation upon binding to both CD137 and OX40. F-star expects to enroll up to 70 patients in a Phase 1 dose escalation clinical trial to assess the safety, tolerability and efficacy of FS120 in patients with advanced malignancies and include those patients who have high co-expression of CD137 and OX40.
F-star also plans to submit a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for FS222 in the second half of 2020 and to initiate a Phase 1 clinical trial in patients with advanced cancers in the first quarter of 2021. FS222 has the potential to provide clinical benefit through multiple mechanisms based on its tetravalency. These include: (1) blocking the PD-1/PD-L1 immunosuppressive pathway and (2) conditionally clustering and crosslinking CD137 receptors, resulting in activation of CD137 in a PD-L1-dependent manner. F-star believes this dual mechanism of action could amplify the anti-tumor activity of FS222. F-stars preclinical data shows that FS222 has the potential to be more effective than a combination of traditional PD-L1 and CD137 antibodies. FS222 has been designed with specific mutations to make its activity independent of binding to Fc gamma receptors. PD-L1 is frequently highly expressed on cells within cancer tissue compared to non-cancer tissue. Therefore, F-star believes this will make FS222 immune activation conditional within cancer tissue, limit potential systemic toxicities and lead to safety benefits.
In 2019, combined sales of current immuno-oncology therapies were estimated to be approximately $23.5 billion. Despite the commercial success of currently approved immuno-oncology products, only approximately 20% of patients realize a long-lasting benefit from these treatments, leaving a large, unserved patient population without effective treatment options.
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F-star believes its mAb2 bispecific antibodies may address the limitations of current immuno-oncology therapies through the following advantageous characteristics that differentiate F-stars mAb2 product candidates, including F-stars novel tetravalent and natural human antibody formats:
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Novel Tetravalent Format. F-star engineers its mAb2 bispecific antibodies to simultaneously bind two different targets, with two binding sites for each target. The ability to bind F-stars distinct targets is known as tetravalency. This unique tetravalent format is designed to enable F-stars mAb2 bispecific antibodies to achieve more efficient crosslinking, clustering or conditionality than other bispecific antibodies, which have the potential to elicit improved biological responses and enable F-stars mAb2 bispecific antibodies to overcome tumor evasion pathways. These three key characteristics are described further below: |
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Crosslinking. Crosslinking is the act of bringing either two target-bearing cells, or two targets on the same cell, into close proximity. The dual binding sites for each target, within F-stars bispecific antibodies, enables durable and strong target crosslinking through the ability to engage with target-bearing cells simultaneously, for example, engaging both tumor cells and immune cells. |
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Clustering. Many cellular receptors can only be optimally activated when many of those receptors are brought into close physical proximity on the cell surface, referred to as clustering. Since F-stars mAb2 bispecific antibodies have F-stars distinct binding sites, they can potentially induce more potent clustering than non-tetravalent bispecific antibody formats. |
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Conditionality. Conditionality occurs when immune activation is dependent on the bispecific antibody binding both targets simultaneously, often in the tumor microenvironment. F-star is able to leverage the tetravalent format of its mAb2 bispecific antibodies so that targets are only activated when they are simultaneously bound. |
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Natural Human Antibody Format. F-stars mAb2 bispecific antibodies are designed to conserve the natural human antibody format, with greater than 95% identity, allowing F-star to leverage the following advantages: |
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Minimal systemic toxicity. Since F-stars mAb2 bispecific antibodies use a natural human antibody format, without synthetic linkers and domains, there is lower potential for systemic toxicity than traditional and bispecific antibodies. |
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Low immunogenicity risk. The natural human antibody format of F-stars mAb2 bispecific antibodies and the low number of modifications F-star engineers into its mAb2 bispecific antibodies is designed to help mitigate immunogenicity risk, or the risk that the immune system recognizes the mAb2 bispecific antibody as foreign, potentially resulting in lower exposure and toxicity. |
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Ease of manufacturability. F-star is able to produce F-stars mAb2 bispecific antibodies through established manufacturing processes readily and at large scale without potentially complicating additions, such as domain assembly or other modifications. |
F-star believes the novel tetravalent and natural human antibody formats of its mAb2 bispecific antibodies have the potential to focus immune activation to enhance efficacy and reduce systemic toxicities.
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The following table sets forth F-stars mAb2 product candidates, which F-star has developed using its proprietary mAb2 technology, and their current development stages and anticipated upcoming milestones.
The tetravalent format of FS118 simultaneously targets two immune checkpoint receptors, LAG-3 and PD-L1, to directly address known tumor evasion pathways. FS118 is currently being evaluated in an open label Phase 1 clinical trial in heavily pretreated patients with advanced cancer (a median of six different lines of prior treatment) and who have failed PD-1/PD-L1 therapy. Initial data from this trial have demonstrated that administration of FS118 has been well-tolerated and has provided long-term disease control in these patients. F-star expects to report the final primary objectives of the trial and clinical data in the fourth quarter of 2020. F-stars pipeline also includes FS120, which targets CD137 and OX40 and FS222, which targets PD-L1 and CD137, respectively. For FS120, F-star plans to initiate a Phase 1 clinical trial in patients with advanced cancers in the fourth quarter of 2020 and for FS222, F-star intends to submit a CTA to the EMA in the second half of 2020 and to initiate a Phase 1 clinical trial in patients with advanced cancers in the first quarter of 2021.
F-star leverages its proprietary mAb2 technology to build its portfolio of wholly-owned immuno-oncology mAb2 product candidates and has generated a panel of early stage Fcab building blocks against a range of targets with the potential to go beyond immuno-oncology. These Fcab building blocks have been used to generate not only bispecific antibodies but also trispecific antibodies. With over 200 granted patents and 60 pending applications protecting F-stars mAb2 technology and pipeline, F-star believes it has a leading position in mAb2 bispecific antibody development and third parties are prohibited from utilizing F-stars mAb2 technology without obtaining a license from F-star.
F-star has collaborative partnerships with Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany, and Denali Therapeutics Inc., which enable it to further validate F-stars technological approach. To date, F-star has generated more than $165 million in non-dilutive revenue. F-star believes that these partnerships will provide both continued validation and ongoing revenue as F-star continues to advance F-stars proprietary pipeline.
F-star is led by a team of highly experienced executives, clinicians, scientists and advisors with notable expertise in antibody research, immuno-oncology, antibody manufacturing and clinical development. F-stars team has spent over a decade developing its proprietary mAb2 technology into a robust drug discovery platform. F-stars team has collectively worked on the development of 20 marketed products and has worked at companies including AstraZeneca, BMS, Celgene Corporation, Domantis Ltd., Eli Lilly, GSK, Immunocore Ltd. and Pfizer Inc. (Pfizer).
Strategy
F-stars mission is to generate highly differentiated, best-in-class mAb2 product candidates that will transform the lives of patients with cancer. The key elements of F-stars strategy include:
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Rapidly accelerating the clinical development of F-stars three novel mAb2 product candidates to treat a range of advanced cancers. F-star believes its mAb2 product candidates represent potentially best-in-class immuno-oncology therapies that address a variety of patients with cancer inadequately treated with existing therapies. F-star believes FS118, which is being evaluated in a Phase 1 clinical trial, has the potential to provide significant clinical benefit through its dual-checkpoint inhibitor |
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targets (LAG-3 and PD-L1). In addition to FS118, F-star anticipates that it will initiate a Phase 1 trial for FS120 (targeting OX40 and CD137, dual-stimulatory) in the fourth quarter of 2020 and will submit a CTA to the EMA for FS222 (targeting CD137 and PD-L1, stimulatory/inhibitory) in the second half of 2020. |
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Initially focusing F-stars development strategy on tumors where checkpoint inhibitors are currently utilized but are poor long-term treatment options, and then subsequently broadening to other tumor types and potentially, first-line therapies. F-stars early-stage clinical trials include or will include a broad range of tumor types to evaluate safety, tolerability and dosing, as well as early signals of efficacy. Following these early-stage clinical trials, F-star intends to employ a patient selection strategy using biomarkers to focus further development on targeted patient subsets. These subsets are expected to include patients with high cancer target co-expression and/or resistance to current checkpoint therapies. F-star believes its mAb2 bispecific antibodies may also ultimately deliver therapeutic benefit in a broader range of tumors, expanding beyond the initial indications F-star may pursue. F-star believes its development strategy best serves the patient, can be efficiently pursued by F-stars organization and, is likely to lead to a rapid development strategy and regulatory pathway to market. For example, F-star has identified several tumor types which have a strong fit with the potential FS118 mechanism of action, including appropriate target expression. |
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Leveraging the transformational potential of F-stars modular antibody technology platform to create a leading immuno-oncology pipeline of differentiated clinical assets capable of improving patient outcomes. F-stars proprietary mAb2 bispecific antibodies have a number of potential advantages resulting from their novel tetravalent and natural human antibody formats. This approach could provide therapeutic advantages compared to other modalities, such as combinations of monospecific and other bispecific antibodies, which F-star believes will result in improved efficacy, minimized toxicity and simplified manufacturability. F-star believes its technology has the potential to be matched with any antibody domain in a modular plug-and-play approach to further expand its innovative pipeline of mAb2 product candidates. F-star believes these benefits provide multiple opportunities to consistently generate clinical candidates that could potentially address the needs of patients who are without adequate therapeutic options. |
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Leveraging and continuing to build F-stars comprehensive intellectual property portfolio in order to protect F-stars dominant position in mAb2 bispecific antibodies. F-star has built a comprehensive patent portfolio around its technology and product pipeline with over 200 granted patents and 60 pending applications. This patent estate covers F-stars mAb2 bispecific format and aims to provide F-star with robust intellectual property exclusivity and prohibit use of F-stars technology by third parties. F-star intends to continue to seek additional patent protection as it develops additional novel mAb2 product candidates. |
The Immuno-oncology Challenge and F-stars mAb2 Technology
Cancer Treatment Overview
The incidence of cancer is increasing due to the aging of the world population, as well as an increasing prevalence in individuals of known risk factors. Based on GLOBOCAN 2018 estimates, approximately 18.1 million new cancer cases were diagnosed and 9.2 million cancer deaths occurred in 2018 worldwide. Cancer treatment has traditionally included chemotherapy, radiation, hormone therapy, surgery or a combination of these approaches. While these approaches can be effective in treating certain types of cancers, many can also cause toxicities that may have life-threatening consequences, lower quality of life or untimely termination of treatment. Furthermore, F-star believes the traditional therapeutic approaches have reached their efficacy plateau with limited room to prolong the patients life expectancy. More recently, cancer research has leveraged antibody approaches to target the emerging field of immuno-oncology, which aims to enhance natural anti-tumor immune responses by, for example, overcoming mechanisms that cancer cells have developed to evade the immune system. Initially, antibody approaches were developed for treatment in second- or third-line settings but, recently, have become more common as the standard of care, first-line treatment for a variety of tumor types, including
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non-small cell lung cancer, melanoma, renal cell carcinoma, liver cancers, gastric cancers and head and neck cancers, amongst others. F-star believes this has created a significant treatment gap and new unmet need for the large number of patients whose disease becomes resistant to those antibodies.
Successes and Limitations of Immuno-oncology
Under normal conditions, cell surface proteins known as immune checkpoints help to control T cell attacks on healthy cells in the body. The activity of stimulatory checkpoints that activate or hit the gas on immune response is balanced by inhibitory checkpoints that inactivate or apply the brake on the immune response. The immune system recognizes cancers and mobilizes special immune cells known as lymphocytes, which are primarily T cells and B cells, to attack the tumor. A specific type of lymphocyte with the capacity to recognize and attack the tumor, known as tumor infiltrating lymphocytes (TILs), travel to and infiltrate into the tumor. However, the anti-tumor effect of the TIL is usually short-lived, as some cancer cells overexpress inhibitory immune checkpoints, which suppress the immune system and enable the tumor cells to evade elimination. Popular immuno-oncology approaches to enhance anti-tumor immune responses include the use of traditional monoclonal antibodies, which F-star refer to as traditional antibodies, antibody combinations and bispecific antibodies to overcome these immune checkpoint blockades and engage the immune system to fight the cancer. One of the few approved approaches involves the use of traditional antibodies that turn off certain inhibitory checkpoints. The use of traditional antibodies to activate stimulatory checkpoints within the immune system is also being explored extensively, but with less notable clinical success to date.
One of these inhibitory checkpoints, programmed cell death protein 1 (PD-1), is expressed on T cells and can be controlled by programmed cell death ligand 1 (PD-L1), which is a protein that is overexpressed by some tumors in an attempt by the tumor to inhibit natural immune response. Traditional antibody therapeutics against PD-1 or PD-L1 have been transformational for some patients with long-lasting tumor control. However, large patient populations are resistant. Resistance to PD-1/PD-L1 regimens can come in two main forms. Primary Resistance is where the cancer shows no sensitivity to treatment and continues to grow. Acquired Resistance to PD-1/PD-L1 regimens, sometimes referred to as secondary resistance, is where there is initial sustained (greater than or equal to three months) clinical benefit (defined as a complete response, partial response, or stable disease) from therapy but the cancer then starts to grow again while the patient is still being treated. A meta-analysis of data from several well-controlled clinical trials with PD-1 or PD-L1 therapeutic antibodies indicated that responses were seen in only approximately 20% of treated patients, compared to approximately 9% of control patients, using RECIST (response evaluation criteria in solid tumors) criteria. Besides PD-1/PD-L1, it is generally believed that there are multiple other immuno-oncology checkpoint targets with the potential to improve patient response rates alone or when used in combination.
Other Antibody Approaches in Immuno-oncology
One approach to address patient populations with Primary or Acquired Resistance on monotherapy is the use of a combination of two traditional antibodies to inhibit and/or activate two checkpoint pathways at the same time. Such traditional antibody combination treatment has been shown to have some success in limited settings, leading to an additive clinical benefit. The combination of PD-1 and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), antibodies, for example, increases overall survival of melanoma patients when compared to CTLA-4 monotherapy (37.6 months versus 19.9 months, respectively). However, the toxicity observed when PD-1 and CTLA-4 antibodies are used individually (21% and 28%, respectively, grade 3 or 4 adverse events) is increased when they are used in combination (59% grade 3 or 4 adverse events). This increased toxicity has limited the clinical application of this combination approach. Additionally, using two traditional antibodies can increase costs and administrative burden to patients, physicians and the broader healthcare system.
The goal of targeting two cancer pathways at the same time can also be achieved by bispecific antibodies, which have several benefits over existing mono- or combination therapies. This approach builds on the strengths of using a combination of two traditional antibodies and potentially addresses some of their limitations. Generally, bispecific antibodies have the potential to elicit improved biological responses relative to traditional antibodies or combinations thereof. Some bispecific antibodies are able to achieve improved responses through
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the deployment of one or more of crosslinking, clustering and conditionality, which F-star refer to collectively as the 3Cs:
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Crosslinking. Crosslinking is the act of bringing either two target-bearing cells, or two targets on the same cell, into close proximity for optimal biological effect. As a result of this crosslinking, bispecific antibodies have the potential to induce novel desirable biological responses. Binding to two different cells, for example a tumor cell and a T cell, can result in the recruitment of T cells to the tumor site, thereby increasing the anti-tumor activity, as well as reducing toxicity. |
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Clustering. Much of the regulation of the immune system occurs through cell-surface proteins known as receptors. Many cellular receptors can only be optimally activated when many of those receptors are brought into close physical proximity on the cell surface, referred to as clustering. By binding two target receptors, bispecific antibodies can group together the receptors on the cell, leading to activation of certain receptors. In the context of modulating the immune response, receptor clustering and activation can increase the likelihood of anti-tumor activity. |
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Conditionality. The binding of a bispecific antibody to both antigens can induce immune activation. Conditionality occurs when immune activation is dependent on the bispecific antibody binding both targets simultaneously, usually in the tumor microenvironment. Conversely, where one antigen is bound by the bispecific antibody resulting in immune activation without the need for simultaneous binding to the other target, conditionality does not exist. When there is conditional activity, increased localized anti-tumor activity can be elicited, while, in the absence of conditional activity, there is greater risk for systemic toxicity. |
When bispecific antibodies can achieve one or more of the 3Cs, they may be able to concentrate their activity at the tumor site, potentially increasing efficacy with an improved safety profile. Moreover, since bispecific antibodies are a single-infused product, they offer administrative benefits for patients and healthcare professionals as compared to a combination of traditional antibodies that are individually infused.
Many different molecular design approaches have been taken to create bispecific antibodies against a range of target pairings. These include heterodimeric bispecific IgG antibodies and alternative scaffold bispecific antibodies. These all aim to achieve the aforementioned characteristics of the 3Cs.
Heterodimeric Bispecific IgG Antibodies
Heterodimeric bispecific antibodies seek to conserve the native architecture of the IgG molecule by incorporating asymmetric chain pairings into the same molecule such that each of the two binding sites in the Fragment variable (Fv), region of the antibody structure is able to bind different targets. This structure supports bispecific crosslinking of targets but is limited to monovalent binding at each of these sites, meaning they cannot achieve tetravalent clustering. The strong conservation of the native IgG architecture supports IgG-like manufacturing.
Alternative Scaffold Bispecific Antibodies
Another approach to achieving bispecificity is to engineer modular antibody target binding domains, or fragments, into so-called alternative scaffolds. Alternative scaffolds take many forms, some of which can achieve tetravalent bispecificity and support target crosslinking. However, such approaches result in a significant departure from the natural IgG architecture which can result in a variety of problems. One such approach could involve combining two different antibody fragments to bind to two targets. However, such architecture lacks important regions that protect the molecule from natural breakdown in circulation by the neonatal fragment crystallizable (Fc), receptor, resulting in a potentially short half-life or lessened persistence. Other approaches to alternative scaffolds involve bolting on such antibody fragments to natural IgG antibodies. In these cases, manufacturing of the molecules becomes a significant challenge. In addition, the departure from the natural antibody structure increases immunogenicity risk.
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F-stars mAb2 Technology
F-stars platform is designed to effectively achieve the 3Cs while also conserving the natural human antibody format. F-star believes this natural human antibody format, with greater than 95% identity to the unmodified Fc region, is the ideal approach to target unmet medical needs in immuno-oncology.
F-stars mAb2 Potential Advantages over Other Antibodies and Bispecific Antibodies
Novel Tetravalent Format
F-star believes its strong intellectual property position combined with over a decade of research and testing focused on the development of its proprietary technology put it in the unique position to produce mAb2 bispecific antibodies through the introduction of an additional and proprietary second set of antigen binding sites into the Fc domain while also conserving the natural human antibody format. F-star believes it is differentiated in its approach in that F-star engineers mAb2 bispecific antibodies to contain two independent antigen binding regions: (1) a dual binding site in the normal antibody antigen binding domains (Fv portions), of the antibody and (2) a second, proprietary, dual binding site introduced into the Fc portion of the antibody. F-star refers to this portion of a mAb2 bispecific antibody as an Fcab (Fc with antigen binding). This unique tetravalent format is designed to enable F-stars mAb2 bispecific antibodies to achieve more efficient crosslinking, clustering or conditionality than other bispecific antibodies. F-stars mAb2 bispecific antibodies have the potential to elicit improved biological responses and overcome tumor evasion pathways, which F-star believes positions them as attractive candidates for clinical development.
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Tetravalent crosslinking. The tetravalent format of F-stars mAb2 bispecific antibodies is designed to allow for more efficient target cell crosslinking than certain bispecific antibodies because there is an additional, second set of dual binding sites in the Fc region, and both sets can be engineered to engage with antigens that are found on both tumor cells and immune cells. For F-stars mAb2 product candidates that target tumor-associated antigens, such as PD-L1 (FS118 and FS222), crosslinking also supports safety by targeting the mAb2 product candidates to the tumor, localizing the immune activation and thereby minimizing systemic toxicities. |
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Optimal clustering. Antibodies with more than one binding site for a single receptor promote clustering of cellular receptors on the cell surface, resulting in robust activation of targets. Because each of F-stars mAb2 bispecific antibodies has F-stars distinct binding sites, two for each antigen, they are designed to potentially induce more potent activation of multiple cellular receptors, including those on single cells, than other bispecific antibodies. This is particularly useful for F-stars mAb2 product candidates FS120 and FS222, which activate costimulatory molecules such as CD137 which employ clustering for potent activation. |
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F-star believes, through its novel tetravalent format with bivalent binding to each target, that its mAb2 bispecific antibodies have the potential to enhance efficacy and reduce potential for systemic toxicities.
Natural Human Antibody Format
F-stars mAb2 bispecific antibodies are designed to conserve the natural human antibody format. With greater than 95% sequence identity to the equivalent traditional antibody, F-star is able to leverage the following advantages:
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Plug-and-play. F-star refers to its proprietary platform as modular antibody technology, because F-stars library of Fcabs can be combined in a modular fashion with potentially any standard antibody antigen binding domains. This plug-and-play approach allows for rapid drug discovery to identify optimal target pairings, resulting in the creation of a broad portfolio of mAb2 bispecific antibodies. F-stars Fcabs contain new target binding sites resulting from minimal modifications made in the Fc domain of the existing antibody structure. F-star routinely generates, in parallel, Fcabs that bind to human targets as well as those that bind to mouse targets. From these mouse Fcabs, F-star generate mouse mAb2 bispecific antibody equivalents that can be used to test activity in animal models. The modular nature of the technology enables the rapid generation of novel mAb2 product candidates. |
F-stars Modular Antibody Technology
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Minimized systemic toxicity. Traditional antibodies targeting costimulatory molecules require engagement with Fc gamma receptors to induce target crosslinking, clustering and activation. However, binding to these receptors is often weak and the number of receptors is highly variable in tumor cells, which can lead to variable levels of immune cell activation. Additionally, engagement with Fc gamma receptors can result in binding to normal cellular receptors found in healthy cells, potentially resulting in systemic activation such as antibody-dependent cellular |
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cytotoxicity (ADCC). Accordingly, F-star can engineer specific mutations in the Fc domain of F-stars mAb2 bispecific antibodies to prevent binding to Fc gamma receptors and eliminate Fc gamma receptor-mediated crosslinking. As a result, F-stars mAb2 bispecific antibodies can potentially improve immune activation while minimizing systemic toxicity. |
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Low immunogenicity risk. The natural human antibody format of F-stars mAb2 bispecific antibodies and the low number of modifications F-star engineers into its mAb2 bispecific antibodies is designed to help mitigate immunogenicity risk. |
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Ease of manufacturability. F-star is able to produce its mAb2 bispecific antibodies through established manufacturing processes readily and at large scale without potentially complicating additions, such as domain assembly or other modifications. F-stars mAb2 bispecific antibodies also have pharmacologic properties consistent with other traditional antibody products, potentially allowing dosing to be adjusted based on patient response and off-the-shelf usage. |
By leveraging these characteristics, which are demonstrated in the graphic below, F-star is developing a broad pipeline of mAb2 product candidates.
F-stars mAb2 Solution to the Unmet Medical Need in Immuno-oncology
In 2019, combined sales of current immuno-oncology therapies were approximately $23.5 billion worldwide. Despite the commercial success of these products, only approximately 20% of patients realize a long-lasting benefit from these treatments, leaving a large, unserved patient population without effective treatment options. F-stars mAb2 bispecific antibodies have the potential to overcome the limitations associated with current antibody therapies in immuno-oncology. F-stars mAb2 bispecific antibodies not only bind to two cancer targets at the same time, but the efficient receptor crosslinking and clustering of tumor and immune cells can also increase overall potency and biological response. F-stars current mAb2 product candidates are directed against targets that have already demonstrated some level of activity in clinical trials using single traditional antibodies. The target pairings for F-stars mAb2 product candidates are selected on the basis of co-expression in tumors of defined patient populations with an unmet medical need, some of which have orphan status. F-stars mAb2 product candidates are progressed only if they demonstrated potential advantages in preclinical studies, such as safety and/or potency, beyond what would be achieved with the combination of two traditional antibodies. F-star aims to identify subsets of patients most likely to respond to this treatment approach and to develop proof-of-concept clinical trials, with a focus on subsets of more common cancers and potentially orphan indications to facilitate a rapid path to registration and approval.
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FS118 F-stars LAG-3 and PD-L1 mAb2 Bispecific Antibody
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F-stars most advanced product candidate, FS118, is an anti-cancer mAb2 bispecific antibody targeting two receptors, PD-L1 and LAG-3, both of which are established pivotal targets in immuno-oncology. F-star is conducting an open-label, dose-escalation Phase 1 clinical trial with FS118 in patients with advanced cancers that have progressed on PD-1/PD-L1 checkpoint inhibitor therapy and standard of care. F-star expects to report Phase 1 results in the fourth quarter of 2020 and initiate a proof of concept trial for FS118 in the first quarter of 2021 in patients with acquired resistance head and neck cancers. F-stars current findings support the testing of FS118 in cancers with Acquired Resistance to prior PD-1/PD-L1 inhibitors. |
Inhibitory Roles of LAG-3 and PD-L1 in Immuno-oncology
PD-1 is a checkpoint inhibitor that is present on the surface of activated T cells and has a role in downregulating the immune system to help prevent an attack on healthy tissue. However, this inhibitory mechanism can also prevent the immune system from killing cancer cells. PD-L1, the ligand for PD-1, is expressed by a broad range of both tissues and immune cells. A wide range of tumors, including solid tumors, can upregulate PD-L1 in response to pro-inflammatory cytokines, such as interferon gamma. Engagement of PD-L1 with PD-1 on activated tumor infiltrating lymphocytes (TILs), can deliver inhibitory signals that protect the tumor from immune destruction.
LAG-3 is also a checkpoint inhibitor expressed on immune cells, including activated T cells. LAG-3 binds to a group of cell surface proteins known as major histocompatibility complex (MHC), class II molecules that are present on antigen presenting cells. MHC proteins are responsible for presenting foreign antigens to the immune system, after which the T cells are activated to attack and clear the foreign entity. When MHC class II molecules bind to LAG-3, this T cell activation is suppressed, which, under normal conditions, helps to prevent over activation of the immune system. In tumors, LAG-3 becomes overexpressed on TILs, thereby suppressing the T cell activation needed for an anti-tumor immune response. Accordingly, LAG-3 expression in TILs is generally associated with poor prognosis.
Potential Clinical Applications of a LAG-3/PD-L1 Bispecific Antibody
Therapeutic antibodies that reverse the immunosuppression of checkpoint inhibitors, thereby releasing the brake to allow the T cell to attack the tumor cell, have been clinically successful. Currently, several PD-1/PD-L1 antibodies are in development or have been approved by the FDA and other regulatory agencies in a variety of tumor types, including lung cancers, melanoma, renal cancers, bladder cancers, gastro-intestinal cancers, liver, head and neck and breast and cervical cancers. This cancer population represented over 10 million cases worldwide in 2018. Although long-lasting responses to PD-1/PD-L1 have been observed, the cancer ultimately becomes resistant, leaving a large, unserved patient population without effective treatment options, despite a portion of these patients expressing PD-1/PD-L1.
Emerging data suggest that LAG-3 upregulation may be a mechanism of resistance to PD-1 or PD-L1 therapy. A key observation is that therapeutic inhibition of the PD-1/PD-L1 checkpoint pathway leads to increased expression of LAG-3, which, in turn, may prevent responses to PD-1/PD-L1 therapy. Both LAG-3 and PD-1 become overexpressed on TILs in multiple preclinical tumor models and the combination of LAG-3 and PD-1 antibodies have demonstrated improvement of the anti-tumor response in murine models compared to blocking either one alone. The potential therapeutic benefit of the combination of traditional antibodies and bispecific antibodies targeting PD-1 and LAG-3 has been investigated in several clinical trials, and preliminary clinical results have indicated activity in PD-1/PD-L1 treatment naïve and resistant tumors.
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Based on results generated using a combination of two traditional antibodies targeting PD-1 and LAG-3, and the observation that an increase in LAG-3 expression may contribute to resistance to PD-1 checkpoint therapy, F-star believes that a bispecific antibody that targets both PD-L1 and LAG-3 simultaneously, such as FS118, has broad potential as an immuno-oncology therapeutic. Simultaneous targeting of LAG-3 and PD-L1 with a bispecific antibody not only releases the brakes of two immunosuppressive pathways, it may also have advantages over a combination of traditional antibodies by focusing these effects at PD-L1 positive sites in the tumor or by crosslinking between immune cells in the tumor microenvironment. Recently, LAG-3 shedding was found to correlate with responsiveness to PD-1 therapy in murine tumors and in the clinic high levels of LAG-3 on T cells correlated with PD-1 treatment efficacy. Therefore, increased shedding of LAG-3 from the surface of the T cell, due to tetravalent bispecific-binding to LAG-3 and PD-L1, may result in lower LAG-3 levels in the tumor and potentially prevents one of the mechanisms of Acquired Resistance to PD-1/PD-L1 therapies.
Resistance to PD-1/PD-L1 regimens can come in two main forms. Primary Resistance is where the cancer shows no sensitivity to treatment and continues to grow. Acquired Resistance to PD-1/PD-L1 regimens, sometimes referred to as secondary resistance, is where there is initial sustained (greater than or equal to three months) clinical benefit (defined as a complete response, partial response, or stable disease) from therapy but the cancer then starts to grow again while the patient is still being treated. F-stars analysis of preliminary clinical data from the first-in-human study of FS118 indicates that FS118 may have greater clinical activity in patients with Acquired Resistance compared to Primary Resistance. While F-star has not assessed this, it believes that FS118 will have clinical activity in cancer patients who have not previously been exposed to PD-1/PD-L1 therapy.
Tumor types with immuno-suppression or T cell exhaustion may co-express LAG-3 and PD-L1 and could benefit from treatment with F-stars dual checkpoint inhibitor product candidate, FS118. Examples of such tumors include head and neck, soft-tissue sarcoma, mesothelioma, ovarian, gastric cancer, anaplastic thyroid cancer and small cell lung cancer. Globally, this cancer population represents over two million new diagnoses annually. F-stars focus will be on patients with cancers whose tumors co-express LAG-3 and PD-L1 and who have developed Acquired Resistance to PD-1/PD-L1 therapy or who have not yet received it.
Squamous cell carcinoma of the head and neck, otherwise known as head and neck cancer, includes cancers of the mouth (oral cavity, oral cancers, tongue) and throat (oropharynx and tonsils, nasopharynx and hypopharynx), as well as rarer cancers of the nasal cavity, sinuses, salivary glands and the middle ear. According to GLOBOCAN, in 2018 approximately 700,000 new head and neck cancer were estimated to have been diagnosed worldwide. Treatment of patients with advanced head and neck cancer consists of PD-1 therapy alone or in combination with chemotherapy in the first-line, in the metastatic setting. Approximately one-third of these patients develop Acquired Resistance to PD-1 therapy and, therefore, F-star plans to develop FS118 as a sequential treatment for these patients, either alone or in combination with standard of care therapies.
Malignant pleural mesothelioma (MPM), is a rare but aggressive cancer usually caused by asbestos exposure. According to GLOBOCAN, in 2018, it estimates up to approximately 30,433 new patients were diagnosed with MPM. For patients ineligible for surgery, which represents the large majority of this patient population, the first-line treatment consists of chemotherapy. Recently, published data from a randomized Phase 3 trial comparing the current standard of care of chemotherapy to the combination of a PD-1 inhibitor and a CTLA-4 inhibitor defines a new standard of care therapy and an opportunity to investigate the efficacy of FS118 in Acquired Resistance patients.
F-stars Solution: FS118
FS118 is a mAb2 bispecific antibody that can simultaneously bind to LAG-3 through its Fcab domain and PD-L1 via its Fv domain. FS118 has demonstrated the potential to provide clinical benefit through multiple mechanisms based on its tetravalency. These include: (1) blocking the PD-1/PD-L1 immunosuppressive pathway, (2) blocking the LAG-3/MHC class II molecules interactions and (3) crosslinking and potentially clustering PD-L1 and LAG-3 receptors, including between different cells.
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Mechanism of Action of FS118
F-stars preclinical data demonstrated that FS118 has the potential to be more effective than a combination of PD-L1 and LAG-3 traditional antibodies. Moreover, these preclinical mice studies showed that administration of the mAb2 bispecific antibody led to a downregulation of LAG-3 expression levels on T cells within the tumor, with an increase in serum soluble LAG-3, which F-star believes is due to receptor clustering, and is indicative of the strong pharmacology enabled by tetravalent bispecific binding. F-star believes this an important mechanism for potent disease control.
Ongoing Phase 1 Clinical Trial and Clinical Development Strategy
F-star is conducting a first-in-human Phase 1, open-label, dose-escalation clinical trial of FS118 in patients with advanced malignancies that have progressed on or after PD-1/PD-L1 checkpoint therapy for whom either no effective standard therapy is available or standard therapy has failed. The tumor types enrolled in this trial to date include sarcomas, lung cancers, mesothelioma, bladder cancers, ovarian cancers, prostate cancers, melanoma, mesothelioma, head and neck cancers, cervical cancers and thyroid cancers. Patients were heavily pretreated, including surgical procedures, chemotherapy or radiation therapy, and with a median of six prior lines of therapy. In addition, patients were required to have received prior treatment with a PD-1/PD-L1 containing regimen for a minimum of 12 weeks and subsequently shown disease progression. This patient population derives infrequent benefits from any further PD-1 therapy, and disease worsening may occur within eight weeks without an effective therapy.
Under the current protocol, as depicted below, 43 patients have received FS118 administered intravenously once weekly in three weekly cycles until disease progression. The initial cohorts were enrolled sequentially in single-patient dose escalation cohorts. Because no dose limiting toxicities were observed, further dose escalation up to 20 mg/kg proceeded in a 3+3 design associated with cohort extension to obtain more PK/PD data. The primary endpoints of this trial are safety, tolerability and pharmacokinetics. Secondary endpoints include disease control, as measured by RECIST 1.1 and iRECIST.
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FS118 Phase I clinical trial design
A total of 43 patients were enrolled in this trial at dose levels up to 20 mg/kg. As of July 2020, preliminary data from this trial suggested that weekly administration of FS118 was well-tolerated and did not result in dose- or treatment-limiting toxicities and a maximum tolerated dose was not reached. No safety signals unexpected for the drug class of immune-checkpoint inhibitors were identified in the early study population. The majority (95%) of treatment-emergent adverse events (TEAE), considered by the SRC to be treatment-related were mild to moderate in severity (Grade 1 and 2). FS118-related grade 3 toxicities (liver enzyme increases) were observed in two patients (5%). No deaths were attributed to FS118 treatment. FS118 has been dosed for over 16 months.
Anti-drug antibodies were typically transient in nature. The pharmacokinetic profile confirmed preclinical predictions and PD parameters included a dose-dependent increase in serum soluble LAG-3 and expansion of peripheral T cells. As of July 2020, in a preliminary analysis, a disease control rate of 54% was observed across 20 of 37 evaluable patients. In six of these patients, long term disease control (greater than six months) was observed and it was noted that all of these patients had Acquired Resistance. In Acquired Resistance patients, the disease control rate at six months was 26.9% (six out of 26 patients).
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FS118 Preliminary Phase I clinical trial interim data
The FS118 first-in-human clinical study data support further clinical investigations for monotherapy FS118 in cancers with Acquired Resistance. Initial clinical trials will take place in the second/third line metastatic setting. In order to identify patients who gain more benefit from FS118 therapy, F-star plans to investigate a number of biomarkers. Rational combinations with other anti-cancer therapies are also being considered for patients who are pre-treated with, or naïve to, PD-1/PD-L1 therapy.
F-star plans to initiate a focused monotherapy proof of concept study in selected head and neck cancers with Acquired Resistance in the first quarter of 2021. If the study meets its primary objective of efficacy in LAG-3+/PD-L1+ patients, additional clinical studies in head and neck cancer will follow, assessing FS118 alone or in combination with other tumor targeting antibodies or chemotherapeutic agents. A Phase 3 registration clinical study would subsequently be conducted.
Other tumor types of interest that co-express PD-L1 and LAG-3, such as small cell lung cancer, ovarian cancer, mesothelioma and anaplastic thyroid tumors will be investigated in a basket or platform clinical trial. This is designed to facilitate multiple clinical efficacy signals with FS118 therapy in these tumor types, and has the potential to apply biomarker patient selection strategies to enrich for efficacy and provides opportunity for accelerated approval.
If these trials are successful, F-star intends to seek marketing approval from the FDA, the EMA and other comparable regulatory bodies.
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Preclinical Data
Superior anti-tumor activity observed compared to a combination of traditional antibodies
In order to explore the biology of FS118 in mice, F-star created a mouse mAb2 bispecific antibody equivalent of FS118 (mouse LAG-3/PD-L1 mAb2) and tested its ability to control tumor growth in an established immuno-oncology preclinical mouse model (MC38). In this preclinical model, FS118 effectively reduced tumor growth and was observed to be more potent than the combination of a PD-L1 and a LAG-3 antibody, as demonstrated by the number of tumor-free animals at the end of the preclinical study.
FS118 observed to be a potent activator of T cells in a human cell-based assay
The ability of FS118 to activate human T cells was tested in vitro using immune cells from human blood, as detected by increased interferon gamma release. FS118, which is designed to bind to and crosslink both LAG-3 and PD-L1, was more potent than the combination of the individual bispecific components, suggesting that the tetravalent binding and crosslinking of FS118 led to enhanced immune cell activation.
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FS118 observed to induce shedding of LAG-3 in human ex vivo T cells
In an in vitro T cell activation assay with immune cells expressing PD-L1, it was observed that FS118 increased the concentration of soluble LAG-3 detected in the cell culture medium. This increase in soluble LAG-3 was not observed with the combination of the individual bispecific components, demonstrating a potentially differentiated bispecific antibody mechanism of action for FS118 where LAG-3 shedding requires simultaneous binding to both PD-L1 and LAG-3. An increase in soluble LAG-3 in the blood was observed in a mouse tumor model upon dosing with a mouse LAG-3/PD-L1 mAb2.
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FS120 F-stars OX40 and CD137 mAb2 Bispecific Antibody
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FS120 is an anti-cancer mAb2 bispecific antibody that is designed to bind to and stimulate OX40 and CD137, two proteins found on the surface of T cells that both function to enhance T cell activity. F-star is developing FS120 alone and in combination with PD-1/PD-L1 therapy for the treatment of tumors where PD-1/PD-L1 agents are approved and which have co-expression of OX40 and CD137 in the tumor microenvironment, such as gastric and bladder cancer. F-star has an open IND for FS120 and plans to initiate a Phase 1 clinical trial in patients with advanced cancers in the fourth quarter of 2020. |
Stimulatory Roles of OX40 and CD137 in Immuno-oncology
The biological basis for Primary and Acquired Resistance to current checkpoint therapies has been widely explored, resulting in the identification of many contributory factors. Key among these factors are the number of TILs and the number of mutations in the tumor cells, which is known as the tumor mutational burden (TMB). Tumors with low levels of TILs, referred to as cold tumors, are less responsive or non-responsive to current therapies.
One approach to increase the number and level of activation of TILs is by broad stimulation of the immune system via costimulatory regulators. Preclinical studies showed that the anti-tumor efficacy of therapeutic tumor targeting antibodies can be augmented by the addition of antibodies targeting costimulatory molecules, such as CD137 and OX40.
When TILs first become activated, they upregulate OX40 and CD137 which are members of the tumor necrosis factor receptor superfamily. Further activation can be achieved by stimulation of OX40 and CD137. OX40 stimulation promotes T cell proliferation and survival and decreases the activity of immuno-suppressive T cells to further amplify the immune activation. Moreover, it preserves cellular memory for a more durable response and facilitates migration to other tumor sites. CD137 is expressed on multiple cell types including T cells and natural killer (NK cells). CD137 stimulation on T cells helps to mount an effective immune response by enhancing T cell proliferation and survival. Both the OX40 and CD137 activation pathway requires receptor clustering of the respective molecules on cells that triggers a signaling cascade resulting in enhanced immune response and thereby, tumor cell killing.
Potential Clinical Applications of an OX40/CD137 Bispecific Antibody
OX40 and CD137 agonist antibodies can hit the gas (immune stimulation) and have been shown to be effective immunotherapeutic agents across preclinical cancer models. Traditional OX40 antibodies have been extensively studied in the clinic as monotherapies. In addition, OX40 antibodies have been studied in combination with PD-1/PD-L1 and CTLA-4 antibodies and chemotherapy. Other programs are exploring a triple combination approach with PD-L1, CD137 and OX40 antibodies.
Monotherapy with traditional CD137 antibodies has not restored immune control of cancer in the majority of patients tested in clinical trials. In the case of the two most advanced traditional CD137 antibodies in clinical trials, doses tested have either demonstrated early efficacy but have been limited by severe liver toxicity or have been well-tolerated but have not demonstrated anti-cancer efficacy even at the highest doses tested. Both of these traditional CD137 antibodies are being tested in combination with PD-1/PD-L1 antibodies and other agents to potentially improve efficacy.
OX40 activation predominantly stimulates CD4+ T cells, called helper T cells, whereas CD137 stimulates CD8+ T cells, called killer T cells. F-star believes a bispecific antibody that hits the gas simultaneously through
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OX40 and CD137, such as FS120, will be able to concentrate these different immune cell subsets in the tumor, increasing activity of both helper and killer T cells. In addition, F-star believes this targeted stimulation of the immune system will increase the number of activated TILs in the tumors. Both mechanisms lead to stronger anti-tumor activity and increased therapeutic benefit as compared to traditional antibodies. Using a bispecific dual agonist for broad stimulation could also be combined with checkpoint inhibitors, including PD-1 and PD-L1.
F-star believes that its preclinical data support FS120 being developed in combination with PD-1/PD-L1 therapy or chemotherapy. This approach may broaden the application of PD-1/PD-L1 therapy to tumor types or sub-populations that respond poorly to PD-1/PD-L1 therapy because they are likely to have TILs expressing both CD137 and OX40. Conversely, a PD-1/PD-L1 and FS120 combination may deepen clinical responses and prolong clinical benefit in patients who already gain benefit from PD-1/PD-L1 therapy. In order to select tumor types of interest F-star analyzed gene expression data from solid tumors and found highly correlated expression levels of both OX40 and CD137 in several cancers where PD-1/PD-L1 therapy is approved including, but not limited to, bladder, head and neck, NSCLC and gastric cancer.
Bladder cancer was diagnosed in over 500,000 patients globally in 2018. PD-1 therapy is approved for use in the first line setting in patients who are not eligible for standard chemotherapy and who have high levels of PD-L1. F-star plans to explore PD-1 in combination with FS120 in bladder cancer patients with varying levels of PD-L1. Head and neck cancer affects over 850,000 patients world-wide every year. Therapy with PD-1 regimens is approved as a treatment in the first line setting. However, clinical outcomes remain suboptimal across PD-L1 levels and F-star believes there is an opportunity to bolster PD-1 clinical activity through combining with FS120 in first-line treatment.
F-stars Solution: FS120
FS120 is a mAb2 bispecific antibody that binds to OX40 through its Fcab domain, and CD137 via the Fv domain. FS120 is a dual costimulatory antibody or agonist that hits the gas on immune activation by activating both CD137 and OX40. F-star believes the tetravalent binding of FS120 differentiates it from current therapeutic approaches being developed in the clinic, because FS120 is designed to lead to enhanced clustering and potent and conditional stimulation between T cells (trans) and potentially on the same cell (cis).
Mechanism of Action of FS120
F-stars preclinical studies have shown superior anti-tumor activity of a mouse OX40/CD137 mAb2 compared to a combination of two traditional antibodies. Based on the results, F-star believes FS120 may deliver clinical benefit through mechanisms arising from dual stimulation. These include: (1) activation of TILs in tumors to help overcome checkpoint inhibitory signals, which F-star believes will improve the response rates to PD-1/PD-L1
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inhibitors and (2) increasing the number and persistence of CD4+ (helper) and CD8+ (killer) T cells and destabilizing T regulatory cells, which has the potential to reduce the risk of relapse for patients treated with the standard of care.
Traditional CD137 antibodies have Fc domains that lead to crosslinking using Fc gamma receptors that are widely expressed in the body, which are believed to result in off-tumor activation and subsequent hepato-toxicities. Accordingly, F-star designed FS120 with specific mutations that alter the binding of the Fc domain to Fc gamma receptors to prevent the killing of the immune cells by ADCC and to make FS120 activity independent of Fc gamma receptors, which F-star believes is important for efficacy and safety benefits. Both OX40 and CD137 are found highly expressed in TILs versus blood. Therefore, F-star believes this will make FS120 immune activation conditional within cancer tissue, limit potential systemic toxicities and lead to safety benefits.
Clinical Plans
F-star plans to initiate a Phase 1 open-label, dose-escalation clinical trial of FS120 in patients with advanced cancers in the fourth quarter of 2020. If F-star is able to establish a preliminary safety profile of FS120 in the dose-escalation phase of this trial, F-star will investigate its clinical activity in patients with cancers that co-express OX40 and CD137. Further, F-star intends to explore FS120 in combination with PD-1/PD-L1 therapy focusing on selected tumor types. In the future, FS120 may also be explored in combination with chemotherapy. The initial safety and proof of concept efficacy studies in selected tumor types will be conducted within the Phase 1 protocol. This approach could potentially support expedited regulatory approval and the initiation of additional Phase 3 registrational trials.
Preclinical Data
Co-expression of OX40 and CD137
In an established preclinical mouse tumor model (CT26), F-star analyzed the number of immune cells that co-expressed OX40 and CD137 in the tumor, blood and in the liver. F-star observed that a high number of T cells in the tumor co-expressed OX40 and CD137, whereas T cells in peripheral blood and liver did not co-express OX40 and CD137. Co-expression of OX40 and CD137 has also been observed in human tumors including non-small-cell lung cancer. The higher number of co-expressing T cells in the tumor suggests that the activity of FS120 should be highly active at the tumor site, in comparison to non-specific activation of immune cells throughout the body, potentially providing a safety benefit.
Enhanced anti-tumor response to PD-1 blockade observed
F-star observed a significant reduction in tumor growth in an established preclinical mouse tumor model (CT26) in a treatment with a mouse mAb2 bispecific antibody equivalent of FS120, referred to as the mouse OX40/CD137 mAb2. When the mouse OX40/CD137 mAb2 was used in combination with a PD-1 antibody,
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F-star observed increased long-term survival compared to what was observed with the monotherapy of either PD-1 or the mouse OX40/CD137 mAb2.
FS120 was observed to be superior to antibody combinations in activating human T cells
Human immune cells can be activated in vitro to upregulate OX40. Addition of FS120 to these cells resulted in enhanced stimulation of human T cells, as detected by increased interleukin-2 expression. The combination of CD137 and OX40 traditional antibodies was observed to be ineffective in this assay. F-star believes that, in contrast to the traditional antibodies, FS120s observed potent activity is due to its ability to activate T cells independent of Fc gamma receptors.
FS120 was observed to be well-tolerated in preclinical studies
In an IND-enabling toxicology study conducted in non-human primates, FS120 was observed to be well-tolerated at doses up to the maximum administered dose of 30 mg/kg. No adverse observations, including no acute increases in serum cytokines levels were reported. This was consistent with F-stars results from cytokine release assays performed using human blood. The non-human primate study also showed dose-dependent
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increases in proliferating CD4+ (helper), CD8+ (killer) T cells and NK cells, consistent with F-stars findings in murine pharmacology studies using the OX40/CD137 mAb2 surrogate.
FS222 F-stars CD137 and PD-L1 mAb2 Bispecific Antibody
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FS222 is an anti-cancer mAb2 bispecific antibody that is designed to target both the costimulatory CD137 and the inhibitory PD-L1 receptors, which are co-expressed in a number of tumor types including non-small-cell lung cancer, breast cancer and gastrointestinal cancers such as colorectal and esophageal cancer. F-star plans to submit a CTA in the second half of 2020 and to initiate a Phase 1 clinical trial in patients with advanced cancers for FS222 in the first quarter of 2021. F-star believes there is a strong rationale to combine FS222 with other anti-cancer agents, including targeted therapy and chemotherapy, and this can be done within the Phase 1 study. |
Potential Clinical Applications of a CD137/PD-L1 Bispecific Antibody
A CD137 and PD-L1 bispecific antibody has the potential to increase the efficacy compared to the combination of two traditional antibodies. Both targets are present on tumor and immune cells within the tumor environment. Blocking the PD-L1 pathway acts to release the brake thereby reducing immunosuppression, while stimulating the CD137 pathway acts to hit the gas and amplify immune activation. CD137-driven T cell activation results in interferon gamma cytokine release. This cytokine release causes increases in PD-L1 on tumor and immune cells. F-star believes that this upregulation of PD-L1 could be a resistance mechanism of traditional CD137 antibody therapy that limits its activity in the tumor microenvironment.
F-star intends to develop FS222 in cancers that co-express both CD137 and PD-L1 receptors. Tumors such as non-small-cell lung cancer, triple negative breast cancer, colorectal cancer, esophageal and cancers positive for tertiary lymphoid structures (TLS+) are likely to have tumor-resident T cells and NK cells expressing CD137, as well as cells that express PD-L1. These represent tumor types that individually and collectively have a spectrum of PD-L1 expression from high to low (less than 5% cells that express PD-L1). These cancer types are diagnosed in over 4.5 million patients globally every year and represent attractive indications for FS222. F-star plans to focus on defined clinical segments of these cancers. For example, there is need for sequential treatments after failure on PD-1/PD-L1 regimens in non-small-cell lung cancer, which are currently given in the first-line setting or after failure on targeted agents. F-star believes there is a broad opportunity for FS222, either alone or in combination with other anti-cancer therapies, in treating these patient populations.
F-stars Solution: FS222
FS222 is a mAb2 bispecific antibody that binds to CD137 through its Fcab domain and PD-L1 via the Fv domain. FS222 simultaneously releases the brake on immune control of cancer by blocking the PD-1/PD-L1 pathway and hits the gas on immune activation by activating the CD137 pathway. FS222 has the potential to provide clinical benefit through multiple mechanisms based on its tetravalency. These include: (1) blocking the PD-1/PD-L1 immunosuppressive pathway and (2) conditionally clustering and crosslinking CD137 receptors, resulting in activation of CD137 in a PD-L1-dependent manner. F-star believes this dual mechanism of action would amplify the anti-tumor activity of FS222. F-stars preclinical data shows that FS222 has the potential to be more effective than a combination of traditional PD-L1 and CD137 antibodies.
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Mechanism of Action of FS222
Similar to FS120, FS222 has been designed with specific mutations to make its activity independent of binding to Fc gamma receptors. PD-L1 is frequently expressed at high levels on cells within cancer tissue compared to non-cancer tissue. Therefore, F-star believes this will make FS222 immune activation conditional within cancer tissue, limit potential systemic toxicities and lead to safety benefits.
Clinical Plans
F-star plans to file a CTA in the second half of 2020 and initiate a Phase 1 open-label, dose-escalation clinical trial of FS222 in patients with advanced cancers in the first quarter of 2021. The initial safety and proof of concept efficacy studies in selected tumor types will be conducted within the Phase 1 protocol. While F-star attempts to establish the preliminary safety and optimal dosing regimen for FS222, F-star will simultaneously investigate preliminary efficacy signals with FS222 therapy in a small number of tumor types of interest, potentially including colorectal, non-small-cell lung cancer, esophageal and TLS+ tumors. These data will form the basis for the selection of specific tumor types in which to assess the clinical activity of FS222 in a larger group of patients in the Phase 1 study. This approach could potentially support expedited regulatory approval and the initiation of additional Phase 3 registrational trials.
Preclinical Data
Co-expression of CD137 and PD-L1
In an established preclinical mouse tumor model (CT26), F-star analyzed the percentage of immune cells that co-expressed CD137 and PD-L1, both in the tumor and in the blood. F-star observed that a high number of T cells in the tumor co-expressed CD137 and PD-L1, whereas T cells in peripheral blood did not co-express CD137 and PD-L1. Co-expression of CD137 and PD-L1 has also been observed in human tumors including non-small-cell lung cancer. The higher number of co-expressing T cells in the tumor suggests that the activity of FS222 should be highly active at the tumor site, in comparison to non-specific activation of immune cells throughout the body, potentially providing a safety benefit. In an IND/CTA-enabling toxicology study conducted in non-human primates, FS222 was observed to be well-tolerated at doses up to the maximum administered dose of 30 mg/kg. No adverse observations, including no acute increases in serum cytokines levels were reported. This was consistent with F-stars results from cytokine release assays performed using human blood. The non-human primate study also
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showed dose-dependent increases in proliferating CD4+ (helper), CD8+ (killer) T cells and NK cells, consistent with F-stars findings in murine pharmacology studies using the CD137/PD-L1 mAb2 surrogate.
Superior anti-tumor activity observed compared to a combination of traditional antibodies
In an established preclinical mouse tumor model (MC38), treatment with a mouse mAb2 bispecific antibody equivalent of FS222 (mouse CD137/PD-L1 mAb2) was observed to lead to long-term survival and complete tumor elimination in all treated mice, an effect that was observed to be unmatched by two traditional antibodies in combination. F-star believes this effect was observed because of FS222s ability to deliver the dual anti-cancer mechanisms.
FS222 observed to be a potent activator of human T cells
The ability of FS222 to activate T cells isolated from human blood was tested in vitro. FS222 was observed to be a potent activator of human T cells, as detected by increased interferon gamma release. FS222 was more
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potent than the combination of its individual bispecific components, indicating that FS222s tetravalent binding and crosslinking led to enhanced T cell activation.
FS222-induced T cell activation was observed to be dependent on PD-L1
F-star tested whether FS222s T cell activation was dependent on PD-L1 binding and therefore, conditional. In an in vitro assay with human T cells and other cells expressing PD-L1, F-star observed that FS222 activation of T cells required binding to PD-L1. This demonstrated that FS222 required binding to both CD137 and PD-L1 to crosslink and cluster CD137 and conditionally activate the T cells. As anticipated, in addition to inducing CD137 activation, FS222 also blocked the PD-1/PD-L1 pathway, which F-star has demonstrated in vitro.
Collaborations and License Agreements
2016 License and Collaboration Agreement with Denali Therapeutics Inc.
In August 2016, F-star Biotechnology Limited, F-star Gamma Limited (F-star Gamma), and F-star Biotechnologische Forchungs-und Entwicklungsges.m.b.H entered into a license and collaboration agreement (the
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Denali License and Collaboration Agreement), with Denali Therapeutics Inc. (Denali). The goal of the collaboration was the development of certain constant Fc domains of an antibody with non-native antigen binding activity (Fcabs), to enhance delivery of therapeutics across the blood brain barrier into the brain. The collaboration was designed to leverage F-stars modular antibody technology and Denalis expertise in the development of therapies for neurodegenerative diseases. In connection with the entry into the collaboration agreement, Denali also purchased from the F-star Gamma shareholders an option, which F-star refer to as the buy-out-option, to acquire all of the outstanding shares of F-star Gamma pursuant to a pre-negotiated share purchase agreement.
On May 30, 2018, Denali exercised such buy-out option and entered into a Share Purchase Agreement (the Purchase Agreement), with the shareholders of F-star Gamma and Shareholder Representative Services LLC, pursuant to which Denali acquired all of the outstanding shares of F-star Gamma (the Acquisition).
As a result of the Acquisition, F-star Gamma has become a wholly owned subsidiary of Denali and Denali changed the entitys name to Denali BBB Holding Limited. In addition, Denali became a direct licensee of certain of F-stars intellectual property (by way of Denalis assumption of F-star Gammas license agreement with F-star (the F-star Gamma License)). Denali made initial exercise payments to F-star and the former shareholders of F-star Gamma under the Purchase Agreement and the F-star Gamma License in the aggregate, of $18.0 million, less the net liabilities of F-star Gamma, which were approximately $0.2 million. Of this total, $4.0 million was payable to F-star. In June 2019, Denali made a payment of $1.5 million to F-star upon achieving a GMP Manufacturing milestone. In addition, Denali is required to make future contingent payments, to it and the former shareholders of F-star Gamma, up to a maximum amount of $437.0 million in the aggregate upon the achievement of certain defined preclinical, clinical, regulatory and commercial milestones. Of this total, up to a maximum amount of $91.4 million is payable to F-star. The total amount of the contingent payments varies based on whether F-star deliver an Fcab that meets pre-defined criteria and whether the Fcab has been identified solely by it or solely by Denali or jointly by it and Denali.
Under the terms of the Denali License and Collaboration Agreement, Denali has the right to nominate up to three Fcab targets (Accepted Fcab Targets), within the first three years of the date of the Denali License and Collaboration Agreement. Upon entering into the Denali License and Collaboration Agreement, Denali had selected transferrin receptor (TfR), as the first Accepted Fcab Target and paid it an upfront fee of $5.5 million, which included selection of the first Accepted Fcab Target. In May 2018, Denali exercised its right to nominate two additional Fcab targets and identified a second Accepted Fcab Target. Denali made a one-time payment for the two additional Accepted Fcab Targets of, in the aggregate, $6.0 million and has extended the time period for its selection of the third Accepted Fcab Target until approximately the fourth anniversary of the date of the Denali License and Collaboration Agreement.
Denali is also responsible for certain research costs incurred by F-star in conducting activities under each agreed development plan, for up to 24 months.
Under the terms of the Denali agreements, F-star is prohibited from developing, commercializing and manufacturing any antibody or other molecule that incorporates any Fcab directed to an Accepted Fcab Target, or any such Fcab as a standalone product, and from authorizing any third party to take any such action.
2018 Agreement with Iontas Limited
In March 2018, F-star entered into an agreement (the Iontas Agreement), with Iontas Limited (Iontas), pursuant to which F-star acquired all Iontas right, title and interest in and to certain anti-PD-L1 human antibodies. Additionally, Iontas granted F-star a worldwide, exclusive license under any know-how or related intellectual property rights to exploit any products containing such antibodies. In connection with the entry into the Iontas Agreement, F-star made an upfront payment of £200,000 to Iontas.
Pursuant to the Iontas Agreement, F-star is obligated to pay an annual fee of £50,000 and up to £400,000 in the aggregate for certain specified preclinical milestones on a per product basis. F-star is obligated to pay Iontas up to £13 million in the aggregate upon the achievement of certain development and regulatory milestones and up to £12.75 million in the aggregate upon the achievement of certain commercial milestones, in each case on a per product basis.
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Unless earlier terminated, the term of the Iontas Agreement will continue in perpetuity. F-star may terminate the Iontas Agreement upon specified prior written notice. Additionally, either party may terminate the Iontas Agreement in the event of an uncured material breach under the agreement by the other party or for certain bankruptcy or insolvency events involving the other party.
2018 Amended and Restated PD-LI License Agreements with Kymab Limited
Out-License Agreement
In November 2018, F-star entered into a license agreement (the Kymab Out-License Agreement), with Kymab Limited (Kymab), which amended and restated an original agreement dated April 19, 2016, pursuant to which F-star granted Kymab an exclusive license to certain of F-stars patents and a non-exclusive license to certain of F-stars know-how to research, develop, manufacture, use and commercialize antibodies comprising a PD-L1 Fcab and an Inducible T-Cell Co-Stimulator Fab component, or licensed products, for all therapeutic, prophylactic and diagnostic uses, including the treatment of human and animal disease.
Under the Kymab Out-License Agreement, Kymab must use commercially reasonable efforts to develop and commercialize a licensed product. During the term of the Kymab Out-License Agreement, F-star is subject to certain non-compete obligations. Failure of Kymab to meet certain diligence milestones will relieve it of such non-compete obligations.
Pursuant to the Kymab Out-License Agreement, F-star is entitled to receive a percentage of sublicensing revenue received by Kymab ranging in the low to high single digits. In the event that Kymab is acquired by a third party prior to entering into a sublicense agreement with respect to a licensed product, or, in the case where the acquirer is the sublicensee, then, in lieu of F-stars right to receive a percentage of sublicensing revenue, F-star is entitled to receive development and regulatory milestones of up to £4.75 million in the aggregate, commercial milestones of up to £7.5 million in the aggregate and a low-single digit royalty on net sales of licensed products. In the event that Kymab sells licensed products, F-star is eligible to receive a low-single digit royalty on these net sales on a licensed product-by-product basis. F-stars right to receive royalties under the Kymab Out-License Agreement expires, on a licensed product-by-licensed product and country-by-country basis, on the first to occur of: (i) the expiration, invalidation or abandonment date of the last valid licensed patent claim that covers the manufacture, sale or use of such licensed product in such country, and (ii) the tenth anniversary of the first commercial sale of such licensed product anywhere in the world.
Unless earlier terminated, the term of the Kymab Out-License Agreement will continue in perpetuity. Kymab may terminate the Kymab Out-License Agreement for convenience at any time effective upon expiration of a certain specified notice period. F-star may terminate the Kymab Out-License Agreement in the event of an uncured material breach under the agreement by Kymab. F-star may terminate Kymabs rights under the Kymab Out-License Agreement if Kymab challenges any patent licensed to it under the Kymab Out-License Agreement. Kymab may terminate F-stars rights under the Kymab Out-License Agreement if F-star challenge any patent controlled by Kymab.
In-License Agreement
In November 2018, F-star entered into a license agreement (the Kymab In-License Agreement), with Kymab, which amended and restated an original agreement dated April 19, 2016, pursuant to which F-star obtained from Kymab an exclusive license to certain of Kymabs patents and a non-exclusive license to certain of Kymabs know-how to research, develop, manufacture, use and commercialize antibodies comprising a LAG-3 Fcab and a single specified anti-PD-L1 Fab component, or licensed products, for all therapeutic, prophylactic and diagnostic uses, including the treatment of human and animal disease.
Under the Kymab In-License Agreement, F-star must use commercially reasonable efforts to develop and commercialize a licensed product. During the term of the Kymab In-License Agreement, F-star is subject to certain non-compete obligations, provided that such obligations shall cease upon the termination or expiration of the Kymab Out-License Agreement.
Pursuant to the Kymab In-License Agreement, F-star is obligated to pay Kymab a percentage of sublicensing revenue ranging in the low to high single digits. In the event that F-star is acquired by a third party
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prior to entering into a sublicense agreement with respect to a licensed product, or, in the case where the acquirer is the sublicensee, then, in lieu of F-stars obligation to pay Kymab a percentage of sublicensing revenue, F-star is obligated to pay Kymab development and regulatory milestones of up to £4.75 million in the aggregate, commercial milestones of up to £7.5 million in the aggregate and a low-single digit royalty on net sales of licensed products. In the event that F-star sell licensed products F-star is obligated to pay Kymab a low-single digit royalty on these net sales. F-stars obligation to pay royalties under the Kymab In-License Agreement expires, on a licensed product-by-licensed product and country-by-country basis, on the first to occur of: (i) the expiration, invalidation or abandonment date of the last valid licensed patent claim that covers the manufacture, sale or use of such licensed product in such country, and (ii) the tenth anniversary of the first commercial sale of such licensed product anywhere in the world.
Unless earlier terminated, the term of the Kymab In-License Agreement will continue in perpetuity. F-star may terminate the Kymab In-License Agreement for convenience at any time effective upon expiration of a certain specified notice period. Kymab may terminate the Kymab In-License Agreement in the event of an uncured material breach under the agreement by F-star. Kymab may terminate F-stars rights under Kymab In-License Agreement if F-star challenges any patent licensed to it under the Kymab In-License Agreement. F-star may terminate Kymabs rights under the Kymab In-License Agreement if Kymab challenges any patent controlled by F-star.
2019 License and Collaboration Agreement with Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany (as amended, July 2020)
On May 13, 2019, F-star entered into a license and collaboration agreement (the Ares Agreement), with Ares, pursuant to which F-star granted Ares the option to enter into a worldwide, exclusive license to certain of F-stars patents and know-how to develop, manufacture and commercialize two separate mAb2 antibody products that each contain a specific Fcab and a Fab target pair (each a licensed product), in the field of the treatment and prevention of diseases in humans.
Under the Ares Agreement, F-star received reimbursement of F-stars internal and external development costs for each preclinical program. Under the Ares Agreement F-star conducted certain mutually agreed upon preclinical development activities and delivered data packages to Ares. Following receipt of each data package, Ares had the option to continue with the program and if Ares elected to continue with the program, Ares would be solely responsible for the continued development, manufacture and commercialization of the applicable licensed products. Ares exercised its option in relation to one of the preclinical programs (the First Program) on May 13, 2019, and exercised its option in relation to the second preclinical program (the Second Program) in July 2020.
In July 2020, the Ares Agreement was amended such that F-star granted Ares a time-limited option to enter into a worldwide, exclusive license to develop, manufacture and commercialize two additional mAb2 products (the Third Program and the Fourth Program) in the field of the treatment and prevention of diseases in humans. With respect to the Third Program and Fourth Program, F-star is not required to deliver data packages to Ares, and upon exercise of the option Ares will be solely responsible for the continued development, manufacture and commercialization of the applicable licensed products.
During the term of the Ares Agreement, F-star is subject to certain non-compete obligations.
Pursuant to the Ares Agreement, Ares paid 10 million in connection with the exercise of the option for the First Program and 7.5 million in connection with the exercise of the option for the Second Program. Additionally, Ares is obligated to pay F-star up to 408.5 million in the aggregate for the programs upon the achievement of certain development and regulatory milestones and up to 252 million in the aggregate upon the achievement of certain commercial milestones. F-star is eligible to receive a low single digit royalty on net sales of licensed products. The royalties payable to F-star under the Ares agreement may be reduced under certain circumstances. F-stars right to receive royalties under the Ares Agreement expires, on a licensed product-by-licensed product and country-by-country basis, on the latest of: (i) the expiration, invalidation or abandonment date of the last valid licensed patent claim that covers such licensed product in such country, (ii) the expiration of regulatory exclusivity for such licensed product in such country and (iii) the twelfth anniversary of the first commercial sale of such licensed product in such country.
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In connection with the Ares Agreement, F-star also granted Ares the right to negotiate a royalty agreement in the event of commercialization of FS118, and F-star reserved the right to receive a license to Ares FS118 manufacturing technology and a transfer of certain materials, provided such technology is not subject to a legal restriction. If this royalty agreement is entered into, F-star may be obligated to pay Ares a low single digit royalty on net sales of FS118 products, subject to certain reductions.
Unless earlier terminated, the term of the Ares Agreement will expire on a program-by-program basis on the date on which Ares has no further milestone or royalty obligations with respect to such program. F-star may terminate the Ares Agreement if Ares or any sublicensee challenges any patent licensed to it under the Ares Agreement. Ares may terminate the Ares Agreement on a program-by-program basis for convenience at any time effective upon expiration of certain specified notice periods. Either F-star or Ares may terminate the Ares Agreement in the event of an uncured material breach under the agreement by the other party or for certain bankruptcy or insolvency events involving the other party; provided, however that, in the event of F-stars uncured material breach, under certain circumstances Ares may elect not to terminate the Ares Agreement and instead, as its sole remedy, to reduce future milestone and royalty payments by an agreed upon amount.
Manufacturing
F-star currently generates batches of its mAb2 bispecific antibody candidates in F-stars laboratories for initial preclinical studies using standardized procedures. F-star relies on and expect to continue to rely on third-party contract manufacturing organizations (CMOs), to manufacture clinical materials and any future commercial materials for F-stars mAb2 product candidates. F-star requires its CMOs to produce bulk drug substance and finished drug product in accordance with current Good Manufacturing Practices and all other applicable laws and regulations. F-star maintains agreements with its CMOs that include confidentiality and intellectual property provisions to protect F-stars proprietary rights related to F-stars mAb2 product candidates. F-star believes that the standard IgG platform processes used for mAb2 manufacturing can be transferred to a number of other CMOs for the production of clinical and commercial supplies of F-stars mAb2 product candidates in the ordinary course of business.
Competition
The biotechnology and pharmaceutical industries, in developing novel and proprietary therapies for the treatment of cancer, are characterized by rapidly advancing technologies, intense competition and a strong emphasis on intellectual property. F-star believes that F-stars differentiated technology, dominant intellectual property position, significant development experience and scientific knowledge provide F-star with competitive advantages, but F-star faces potential competition from many different sources, including large biotechnology and pharmaceutical companies, academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for the research, development, manufacturing and commercialization of oncology therapies. F-star anticipates that it will face intense and increasing competition from the constantly evolving therapeutic landscape, as new drugs and therapies enter the market and advanced technologies become available. Any product candidates that F-star successfully develops and commercializes will compete with new oncology therapies that may become available in the future.
F-star competes in the segments of the biotechnology, pharmaceutical and other related markets that develop immuno-oncology therapies. There are many other companies that have commercialized and/or are developing immuno-oncology therapies for cancer including large biotechnology and pharmaceutical companies, such as AstraZeneca, BMS, Lilly, MSD, EMD Serono, Novartis, Pfizer, Genentech, a member of the Roche Group, and Sanofi. Several companies, not limited to those above, are attempting to combine immuno-oncology antibody therapies in order to modulate two cancer pathways simultaneously. Others have developed bispecific antibodies in order to leverage the effect of a combination of single-target traditional antibodies in a single molecule.
With respect to F-stars mAb2 bispecific antibody pipeline, F-star is aware of a number of competitors using other technology methods to create bispecific antibodies to treat a variety of cancer types, including, but not limited to: Eli Lilly, Genmab A/S, Inhibrx, MacroGenics, Merus, Pieris Pharmaceuticals, Roche and Xencor, Inc.
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With respect to F-stars lead mAb2 product candidate, FS118, F-star is aware of other competing molecules targeting LAG-3 and PD-1/PD-L1 receptors. Companies pursuing a bispecific molecule include, but are not limited to: Avacta Group plc, Crescendo Biologics Ltd., GSK, Innovent, Inc. Y-Biologics, MacroGenics and Hoffmann-La Roche. In addition, companies pursuing a combination of two traditional antibodies include, but are not limited to: BMS, C.H. Boehringer Sohn AG & Co. KG, GSK, MSD, Novartis/Immutep Limited, Incyte, Regeneron Pharmaceuticals, Inc. and Symphogen A/S, now a subsidiary of Servier.
With respect to F-stars second mAb2 product candidate, FS120, F-star is aware of other competing bispecific antibodies targeting OX40 and CD137, which include Aptevo Therapeutics. F-star is also aware that Pfizer still has ongoing clinical studies evaluating a combination of CD137 plus OX40 traditional antibodies.
With respect to F-stars third mAb2 product candidate, FS222, F-star is aware of other competing bispecific antibodies targeting PD-L1 and CD137, which include: Genmab/BioNTech SE, Inhibrx/Elpiscience, Merus/Incyte, Numab Therapeutics AG/CStone Pharmaceuticals, Pieris Pharmaceuticals/Servier, Shattuck Labs, I-mab Biopharma, Macrogenics, QLSF Biotherapeutics and Kahr Medical. F-star is aware of other companies pursuing a combination of two traditional antibodies targeting PD-1/PD-L1 and CD137, which include: Lyvgen Biopharma (Suzhou)/MSD, Pfizer, and BMS.
Many of the companies against which F-star is competing or against which F-star may compete in the future, either alone or with their strategic collaborators, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved drugs than F-star does. Mergers and acquisitions in the biotechnology, pharmaceutical and diagnostic industries may result in even more resources being concentrated among a smaller number of F-stars competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with F-star in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and enrolling patients for F-stars clinical trials, as well as in acquiring technologies complementary to, or necessary for, F-stars programs.
F-star could see a reduction or elimination of F-stars commercial opportunity if F-stars competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that F-star may develop. F-stars competitors also may obtain FDA, EMA or other foreign regulatory approval for their products more rapidly than F-star may obtain approval for F-stars, which could result in F-stars competitors establishing a strong market position before F-star is able to enter the market.
Intellectual Property
F-star strives to protect and enhance the proprietary technology, inventions and improvements that are commercially important to the development of F-stars business, including seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties. F-star also relies on trade secrets relating to F-stars proprietary modular antibody technology platform and on know-how, continuing technological innovation and in-licensing opportunities to develop, strengthen and maintain F-stars proprietary position in the immuno-oncology field and other fields that are or may be important for the development of F-stars business. F-star additionally expects to rely on regulatory protection afforded through orphan drug designations, data exclusivity, market exclusivity and patent term extensions where available.
F-stars commercial success may depend in part on its ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to F-stars business; defend and enforce F-stars patents; preserve the confidentiality of F-stars trade secrets; and operate without infringing the valid enforceable patents and proprietary rights of third parties. F-stars ability to stop third parties from making, using, selling, offering to sell or importing F-stars products may depend on the extent to which F-star has rights under valid and enforceable patents or trade secrets that cover these activities. With respect to both licensed and company-owned intellectual property, F-star cannot be sure that patents will be granted with respect to any of F-stars pending patent applications or with respect to any patent applications filed
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by it in the future, nor can F-star be sure that any of F-stars existing patents or any patents that may be granted to F-star in the future will be commercially useful in protecting F-stars commercial products and methods of manufacturing the same.
F-star has developed or in-licensed numerous patents and patent applications and possesses substantial know-how and trade secrets relating to the development and commercialization of F-stars mAb2 product candidates and the underlying modular antibody technology platform. To date, F-stars patent estate includes over 200 granted patents and 60 pending patent applications generally directed to, for example, compositions and methods related to F-stars Fcabs, F-stars modular antibody technology platform, F-stars lead mAb2 product development candidates, and other products, proprietary technologies and processes.
The patent portfolios for the fields containing F-stars most advanced mAb2 product candidates as of the date of this proxy statement/prospectus are summarized below.
FS118 (LAG-3/PD-L1 mAb2)
F-stars patent portfolio related to FS118 includes 12 owned or licensed patent families, which relate generally to the FS118 mAb2 bispecific antibody composition of matter, the LAG-3 Fcab and PD-L1 mAb antibody included in FS118, and methods of making and using the mAb2 bispecific antibody to treat cancer.
Specifically, F-star solely owns two FS118-focused patent families that include claims directed to the FS118 mAb2 bispecific antibody composition of matter and the LAG-3 Fcab included in FS118, respectively, as well as methods of making and using such compositions to treat cancer. Patent applications are pending in each of these families in major territories worldwide, including Australia, Canada, China, Europe, Japan and the United States. Any patents that may issue from these pending applications are expected to expire in 2037, absent any patent term adjustments or extensions.
F-star also solely owns a third FS118-focused patent family directed to FS118 dosing schedules. This patent family consists of a pending international application filed under the Patent Cooperation Treaty (PCT) filed, in 2020. Any patents that may derive from this international application will be expected to expire in 2040, absent any patent term adjustments or extensions.
Further, F-star solely owns patent families in F-stars modular antibody technology platform portfolio that include claims directed to different aspects of the underlying Fcab and mAb2 bispecific antibody technologies utilized in FS118. Issued patents in these families are expected to expire between 2026 and 2028, absent any patent term adjustments or extensions. F-stars modular antibody technology platform portfolio is discussed in more detail below.
Finally, F-star has an exclusive license to research, develop, manufacture, use and commercialize FS118 from Kymab under a number of patents related to the PD-L1 mAb utilized in FS118. Patents are expected to expire up to 2036, absent any patent term adjustments or extensions.
FS120 (OX40/CD137 mAb2)
F-stars patent portfolio related to FS120 includes seven patent families, solely owned by F-star, which relate generally to the FS120 mAb2 bispecific antibody composition of matter, the OX40 Fcab and CD137 antibody included in FS120, and methods of making and using the mAb2 bispecific antibody to treat cancer.
Specifically, F-star solely owns three pending PCT applications and three corresponding Taiwan patent applications with claims directed to the composition of matter of the OX40 Fcab included in FS120, the CD137 antibody included in FS120, and the FS120 mAb2 bispecific antibody, respectively, as well as methods of making and using such compositions to treat cancer. Any patents that may issue from these patent applications will be expected to expire in 2039, absent any patent term adjustments or extensions.
Further, the F-star patent families in F-stars modular antibody technology platform portfolio discussed above include claims directed to aspects of the underlying Fcab and mAb2 technologies utilized in FS120.
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FS222 (CD137/PD-L1 mAb2)
F-stars patent portfolio related to FS222 includes eight patent families, solely owned by F-star, which relate generally to the FS222 mAb2 bispecific antibody composition of matter, the CD137 Fcab and PD-L1 antibody included in FS222, and methods of making and using the mAb2 bispecific antibody to treat cancer.
Specifically, F-star solely owns three patent families with claims directed to the composition of matter of the CD137 Fcab included in FS222, the PD-L1 antibody included in FS222 (acquired under agreement from Iontas), and the FS222 mAb2 bispecific antibody, respectively, as well as methods of making and using them to treat cancer. Each of these patent families consists of a pending PCT application and a pending application in Taiwan, and any patents that may issue from these will be expected to expire in 2039, absent any patent term adjustments or extensions.
F-star also solely owns one patent family related to FS222 with claims directed to mAb2 bispecific antibodies that bind both a tumor antigen and a tumor necrosis factor receptor superfamily (TNFRSF) receptor on the surface of an immune cell and methods of making and using the same to treat cancer. This patent family contains pending patent application in Australia, Canada, China, Europe, Japan, South Korea and the United States. Any patents that may issue from these pending applications will be expected to expire in 2038, absent any patent term adjustments or extensions.
Additionally, the F-star patent families in F-stars modular antibody technology platform portfolio discussed above include claims directed to aspects of the underlying Fcab and mAb2 technologies utilized in FS222.
Platform Technology
F-stars patent portfolio also includes numerous patents and patent applications generally relating to its modular antibody technology platform and other products and programs not currently under development by F-star.
Specifically, F-star owns patent families relating to F-stars modular antibody technology platform, including two patent families that generically claim the technology, one family that claims both the mAb2 technology and the Fcab technology, and one family with claims directed to improved methods for selecting functional Fcabs. Included in these four patent families are six issued U.S. patents, four pending U.S. patent applications, more than 200 issued ex-U.S. patents, and 10 pending ex-U.S. patent applications. Patents in these families are expected to expire between 2026 and 2028, absent any patent term adjustments or extensions.
Individual patents extend for varying periods depending on the date of filing of the patent application or the date of patent issuance and the legal term of patents in the countries in which they are obtained. Generally, patents issued for regularly filed applications in the United States are granted a term of 20 years from the earliest effective non-provisional filing date. In addition, in certain instances, a patent term can be extended to recapture a portion of the U.S. Patent and Trademark Office delay in issuing the patent as well as a portion of the term effectively lost as a result of the FDA regulatory review period. However, as to the FDA component, the restoration period cannot be longer than five years and the total patent term including the restoration period must not exceed 14 years following FDA approval.
Government Regulation and Product Approval
In the United States, the FDA regulates therapeutics like F-stars mAb2 product candidates as biological products, or biologics, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and related regulations. Biologics are also subject to other federal, state, local and foreign statutes and regulations. Failure to comply with the applicable U.S. regulatory requirements at any time during the product development process, approval process or after approval may subject an applicant to significant fines and penalties, including administrative or judicial actions. These actions could include, for example, the suspension or termination of clinical trials by the FDA or an Institutional Review Board (IRB), the FDAs refusal to approve pending applications or supplements, revocation of a biologics license, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions, civil penalties or criminal prosecution. Any such penalty or enforcement action could have a material adverse effect on F-star.
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture and marketing of biologics. These agencies
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and other federal, state, local and foreign entities regulate, among other things, research and development activities and the testing, manufacture, quality control, effectiveness, safety, purity, potency, labeling, packaging, storage, distribution, record keeping and reporting, approval, import and export, advertising and promotion and post-market surveillance of biologics.
The FDAs and comparable regulatory agencies policies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of any future product candidates or approval of product or manufacturing changes, new disease indications, or label changes. F-star cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the United States or abroad.
Biological Product Development
The process required by the FDA before a biologic may be marketed in the United States generally involves the following:
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completion of nonclinical laboratory tests and animal studies according to GLPs, and applicable requirements for the human use of laboratory animals or other applicable regulations; |
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submission of an IND application, which must become effective before clinical trials may begin; |
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approval of the protocol and related documentation by an independent IRB or ethics committee at each clinical trial site before each study may be initiated; |
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performance of adequate and well-controlled human clinical trials according to the FDAs regulations commonly referred to as GCPs, and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity and potency of the proposed biologic for its intended use or uses; |
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submission to the FDA of a Biologics License Application (BLA), for marketing approval that includes substantive evidence of safety, purity, and potency from results of nonclinical studies and clinical trials; |
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satisfactory completion of FDA pre-approval inspections of manufacturing facilities where the biologic is produced to assess compliance with current Good Manufacturing Practice (GMP), requirements to assure that the facilities, methods and controls are adequate to preserve the biologics identity, strength, quality and purity; |
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potential FDA audits of the nonclinical study and clinical trial sites that generated the data in support of the BLA; and |
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FDA review and approval, or licensure, of the BLA, which must occur before the biologic can be marketed or sold. |
The testing and approval process requires substantial time and financial resources, and F-star cannot be certain that any new approvals for F-stars mAb2 product candidates will be granted on a timely basis, if at all.
Preclinical Studies
Before testing any biological product candidate in human subjects, a company must develop extensive preclinical data. Preclinical tests, also referred to as nonclinical studies, generally include laboratory evaluations of product biological characteristics, chemistry and formulation as well as toxicological and pharmacological studies in several animal species to assess the potential quality, safety and activity of the product. Nonclinical studies must be performed in compliance with the FDAs GLP regulations and, as applicable, the U.S. Department of Agricultures Animal Welfare Act and related regulations.
Prior to commencing the first clinical trial in humans, an IND application must be submitted to the FDA. A company must submit preclinical testing results, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical testing may continue even after the IND is submitted. An IND is a request for authorization from the FDA to ship an unapproved, investigational product in interstate commerce and to administer it to humans, and it
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must become effective before clinical trials may begin. The IND application automatically becomes effective 30 days after receipt by the FDA unless the FDA within the 30-day time period raises concerns or questions about the conduct of the clinical trial and places the trial on clinical hold. In such case, the IND application sponsor must resolve any outstanding concerns with the FDA before the clinical trial may begin. The FDA also may impose clinical holds on a biological product candidate at any time before or during clinical trials due to, among other considerations, unreasonable or significant safety concerns, inability to assess safety concerns, lack of qualified investigators, a misleading or materially incomplete investigator brochure, study design deficiencies, interference with the conduct or completion of a study designed to be adequate and well-controlled for the same or another investigational product, insufficient quantities of investigational product, lack of effectiveness or non-compliance. If the FDA imposes a clinical hold, studies may not recommence without FDA authorization and then only under terms authorized by the FDA.
Human Clinical Trials
Clinical trials involve the administration of a biological product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the study sponsors control. Clinical trials are conducted under protocols detailing, among other things, the objective of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety, including stopping results that assure a clinical trial will be stopped if certain adverse events should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND.
Informed consent must also be obtained from each study subject. Further, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and related documentation, including the form and content of the informed consent that must be signed by each study subject or his or her legal representative, before the trial commences at that site. The IRB for each site also monitors the clinical trial until completed. Regulatory authorities, an IRB, a data safety monitoring board or the study sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the participants are being exposed to an unacceptable safety risk.
A clinical trial sponsor is required to submit to the National Institutes of Health (NIH), for public posting on NIHs clinical trial website details about certain active clinical trials and clinical trial results. Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Although sponsors are obligated to disclose the results of their clinical trials after completion, disclosure of the results can be delayed in some cases for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs. Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government. The NIHs Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and both NIH and FDA recently signaled the governments willingness to begin enforcing those requirements against non-compliant clinical trial sponsors.
Human clinical trials are typically conducted in the following phases, which may overlap:
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Phase 1 the product candidate is initially given to healthy human subjects or patients and tested for safety, dosage tolerance, reactivity, absorption, metabolism, distribution and excretion. These trials may also provide early evidence of effectiveness. During Phase 1 clinical trials, sufficient information about the investigational products activity may be obtained to permit the design of well-controlled and scientifically valid Phase 2 clinical trials. |
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Phase 2 clinical trials are conducted in a limited number of patients in the target population to identify possible adverse effects and safety risks, to evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. |
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Phase 3 when Phase 2 evaluations demonstrate that a dosage range of the product appears effective and has an acceptable safety profile and provide sufficient information for the design of Phase 3 clinical trials, Phase 3 clinical trials are undertaken to provide statistically significant evidence of clinical efficacy and to further test for safety in an expanded patient population at multiple clinical trial sites. Phase 3 clinical trials are performed after preliminary evidence suggesting effectiveness of the biologic has been obtained, and they are intended to further evaluate dosage, effectiveness and safety, to establish the overall benefit-risk relationship of the investigational biologic, and to provide an adequate basis for product approval by the FDA. |
All of these trials must be conducted in accordance with GCP requirements in order for the data to be considered reliable for regulatory purposes. Further, during all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events, any findings from other studies, test in laboratory animals or in vitro testing that suggests a significant risk for human subjects or any clinically important increase in the rate of a serious adverse reactions over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsors initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.
The FDA may require, or companies may pursue, additional clinical trials after a product is approved. These so-called Phase 4 clinical trials may be made a condition to be satisfied for continuing product approval. The results of Phase 4 clinical trials can confirm the effectiveness of a product candidate and can provide important safety information. Conversely, the results of Phase 4 clinical trials can raise new safety or effectiveness issues that were not apparent during the original review of the product, which may result in product restrictions or even withdrawal of product approval. If any of F-stars products are subject to post-marketing requirements and commitments, there may be resource and financial implications for F-stars business.
The U.S. Biologics License Application Approval Process
In order to obtain approval to market a biologic in the United States, a BLA must be submitted to the FDA and must provide data establishing to the FDAs satisfaction, among other things, the safety and effectiveness of the investigational product for the proposed indication. Each BLA submission requires a substantial user fee payment unless a waiver or exemption applies. The application includes all relevant data available from pertinent nonclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the products chemistry, manufacturing, controls and proposed labeling, among other things. Data can come from company-sponsored clinical trials intended to test the safety and effectiveness of a use of a product. In addition, the application may include supplemental data from a number of alternative sources, including studies initiated by investigators. The FDA will initially review a BLA for completeness before it accepts it for filing. Under the FDAs procedures, the agency has 60 days from its receipt of a BLA, or the filing period, to determine whether the application will be accepted for filing based on the agencys threshold determination that the application is sufficiently complete to permit substantive review. After the BLA submission is accepted for filing, the FDA reviews the BLA to determine, among other things, whether the proposed product is safe and potent, which includes determining whether it is effective for its intended use, whether it has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the products identity, safety, strength, quality, potency and purity. The FDA may refer applications for novel biological products or biological products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and, if so, under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making its approval decisions.
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During the review and approval process, the FDA also will determine whether a REMS is necessary to assure that the benefits of the new biological product outweigh its risks. A REMS may include various elements depending on what the FDA considers necessary for the safe use of the biologic. These elements range from a medication guide or patient package insert to training and certification requirements for prescribers and/or pharmacies to safe use conditions that must be in place before the product is dispensed. If the FDA concludes that a REMS is needed, the BLA sponsor must submit a proposed REMS plan that the FDA deems satisfactory or the FDA will not approve the BLA.
The FDAs standard review time for a BLA for a new biological product is ten months from the end of the 60-day filing period. Based on pivotal clinical trial results submitted in a BLA, at the discretion of the FDA or upon the request of an applicant, the FDA may grant a priority review designation to a product, which sets the target date for FDA action on the application at six months from the end of the filing period. The FDA assigns priority review designation to a biologic that is intended to prevent or treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. Priority review designation does not change the scientific or medical standard for approval or the quality of evidence necessary to support approval.
After the FDA completes its review of a BLA, it will either communicate to the sponsor that it will approve the product, or issue a complete response letter to communicate that it will not approve the BLA in its current form and to inform the sponsor of changes that the sponsor must make or additional clinical, nonclinical or manufacturing data that must be received before the FDA can approve the application, with no implication regarding the ultimate approvability of the application. If a complete response letter is issued, the sponsor may either resubmit the BLA, addressing all deficiencies identified in the letter, or withdraw the application. Resubmitting a BLA in response to a complete response letter can add additional time to the approval process for a product.
Before approving a BLA, the FDA typically will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA may inspect one or more clinical sites to assure compliance with GCP. If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable, it typically will outline the deficiencies and often will request additional testing or information. This may significantly delay further review of the application. If the FDA finds that a clinical site did not conduct the clinical trial in accordance with GCP, the FDA may, for example, determine the data generated by the clinical site should be excluded from the primary efficacy analyses provided in the BLA. Additionally, notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
Under the PREA, an initial BLA or certain supplements to a BLA for a novel product must contain data to assess the safety and effectiveness of the biologic for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of pediatric data until after approval of the product for use in adults or full or partial waivers from the pediatric data requirement. Unless otherwise required by regulation, PREA does not typically apply to any biological product for an indication for which orphan designation has been granted. The FDASIA, enacted in 2012, made permanent the PREA requirement that a sponsor who is planning to submit a marketing application for a product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must submit an initial Pediatric Study Plan (PSP), within sixty days of an end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 clinical trial. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including trial objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments
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to an agreed upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from pre-clinical studies, early phase clinical trials or other clinical development programs.
The testing and approval process for a biologic requires substantial time, effort and financial resources and this process may take several years to complete. Data obtained from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis or at all. F-star may encounter difficulties or unanticipated costs in F-stars efforts to secure necessary governmental approvals, which could delay or preclude F-star from marketing its products.
Even if a product candidate receives regulatory approval, the approval will be limited to specific disease states, patient populations and/or dosages, or might contain significant limitations on use in the form of warnings, precautions or contraindications, or in the form of a REMS-imposed risk management plan or restrictions on distribution, or the approval may include mandatory post-marketing study or clinical trial requirements. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product, including imposition of restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, requirements to conduct additional studies or trials, or even complete withdrawal of the product from the market. In addition, F-star cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action.
U.S. Post-Approval Requirements
Any products manufactured or distributed by F-star or on F-stars behalf pursuant to FDA approvals will be subject to continuing regulation by the FDA, including requirements for record-keeping, reporting of adverse experiences with the biologic, and submitting biological product deviation reports to notify the FDA of unanticipated changes in distributed products. Manufacturers are required to register their facilities with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP standards. This will require F-star and any third-party manufacturers to implement certain quality processes, manufacturing controls and documentation requirements in order to ensure that the product is safe, has the identity and strength and meets the quality, purity and potency characteristics that it purports to have. There are continuing, annual user fee requirements for any marketed products and the establishments where such products are manufactured, as well as new application fees for supplemental applications with clinical data.
F-star cannot be certain that F-star or F-stars present or future suppliers will be able to comply with the cGMP and other FDA regulatory requirements. If F-stars present or future suppliers are not able to comply with these requirements, the FDA may halt F-stars clinical trials, refuse to approve any BLA or other application, force F-star to recall a product from distribution, shut down manufacturing operations or withdraw approval of the BLA for that biologic. Noncompliance with cGMP or other requirements can also result in issuance of warning letters, civil and criminal penalties, seizures, and injunctive action. The distribution of biological products is subject to additional state requirements and regulations, including record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of prescription biological products.
The FDA and other federal and state agencies closely regulate the labeling, marketing and promotion of biologics. While doctors may prescribe any product approved by the FDA for unapproved uses or patient populations (known as off-label uses), manufacturers may not market or promote such uses. In addition, biologic promotional materials must be submitted to the FDA in conjunction with their first publication or first dissemination. Further, if there are any modifications to the biologic, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new BLA or BLA supplement. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising, injunctions, potential civil and criminal penalties, criminal prosecution and agreements with governmental agencies that materially restrict the manner in which a product approved by FDA may be promoted or distributed.
In addition, the distribution of prescription pharmaceutical products is subject to the PDMA, which regulates the distribution of drugs and biological product samples at the federal level, and sets minimum standards for the registration and regulation of prescription drug distributors by the states. Both the PDMA and
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state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution. Most recently, the DSCSA, was enacted with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United States, including most biological products. The DSCSA mandates phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers over a 10 year period that is expected to culminate in November 2023. From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA. It is impossible to predict whether further legislative or regulatory changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact of such changes, if any, may be.
FDAs Regulation of Companion Diagnostics
F-star believes that the success of certain of its mAb2 product candidates may depend, in part, on the development and commercialization of a companion diagnostic. Companion diagnostics identify patients who are most likely to benefit from a particular therapeutic product; identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; or monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness. Companion diagnostics are regulated as medical devices by the FDA. In the United States, the U.S. Federal Food, Drug, and Cosmetic Act and its implementing regulations, and other federal and state statutes and regulations govern, among other things, medical device design and development, preclinical and clinical testing, premarket clearance or approval, registration and listing, manufacturing, labeling, storage, advertising and promotion, sales and distribution, export and import and post-market surveillance. Unless an exemption or FDA exercise of enforcement discretion applies, diagnostic tests generally require marketing clearance or approval from the FDA prior to commercialization. The two primary types of FDA marketing authorization applicable to a medical device are premarket notification, also called 510(k) clearance, and premarket approval (PMA).
To obtain 510(k) clearance for a medical device, or for certain modifications to devices that have received 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or to a pre-amendment device that was in commercial distribution before May 28, 1976, or a predicate device, for which the FDA has not yet called for the submission of a PMA. In making a determination that the device is substantially equivalent to a predicate device, the FDA compares the proposed device to the predicate device or predicate devices and assesses whether the proposed device is comparable to the predicate device or predicate devices with respect to intended use, technology, design and other features which could affect safety and effectiveness. If the FDA determines that the proposed device is substantially equivalent to the predicate device or predicate devices, the proposed device may be cleared for marketing. The 510(k) premarket notification pathway generally takes from three to 12 months from the date the application is completed, but can take significantly longer.
In contrast, PMA applications must be supported by valid scientific evidence, which typically requires extensive data, including technical, preclinical, clinical and manufacturing data, to demonstrate to the FDAs satisfaction the safety and effectiveness of the device. For diagnostic tests, a PMA application typically includes data regarding analytical and clinical validation studies. As part of its review of the PMA, the FDA will conduct a pre-approval inspection of the manufacturing facility or facilities to ensure compliance with the Quality System Regulation, which requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures. The FDAs review of an initial PMA application is expected to take between six to ten months, although the process typically takes longer, and may require several years to complete. If the FDA evaluations of both the PMA application and the manufacturing facilities are favorable, the FDA will either issue an approval letter or an approvable letter, which usually contains a number of conditions that must be met in order to secure the final approval of the PMA. If the FDAs evaluation of the PMA or manufacturing facilities is not favorable, the FDA will deny the approval of the PMA or issue a not approvable letter. A not approvable letter will outline the deficiencies in the application and, where practical, will identify what is necessary to make the PMA approvable. Once granted, PMA approval may be withdrawn by the FDA if compliance with post-approval requirements, conditions of approval or other regulatory standards is not maintained, or problems are identified following initial marketing.
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In 2014, the FDA issued a final guidance document addressing the development and approval process for In Vitro Companion Diagnostic Devices. According to the agency, for novel therapeutic products that depend on the use of a diagnostic test and where the diagnostic device could be essential for the safe and effective use of the corresponding therapeutic product, the PMA application for the companion diagnostic device should be developed and approved or cleared contemporaneously with the therapeutic, although the FDA recognizes that there may be cases when contemporaneous development may not be possible. However, in cases where a drug cannot be used safely or effectively without the companion diagnostic, the FDAs guidance indicates that the agency will generally not approve the drug without the approval or clearance of the diagnostic device. The FDA also issued a draft guidance in July 2016 setting forth the principles for co-development of an in vitro companion diagnostic device with a therapeutic product. The draft guidance describes principles to guide the development and contemporaneous marketing authorization for the therapeutic product and its corresponding in vitro companion diagnostic. Subsequently, in December 2018, the FDA published a draft guidance entitled Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products that is intended to facilitate class labeling on diagnostic tests for oncology therapeutic products, where scientifically appropriate. The draft guidance notes that in some cases, if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group or class of therapeutic products, the companion diagnostics intended use should name the specific group or class of therapeutic products, rather than specific products.
Once cleared or approved, a companion diagnostic device must adhere to post-marketing requirements for medical device products including the requirements of FDAs Quality System Regulation, adverse event reporting, recalls and corrections along with product marketing requirements and limitations. Like drug and biologic makers, companion diagnostic makers are subject to unannounced FDA inspections at any time, during which the FDA will conduct an audit of the product(s) and the companys facilities for compliance with its authorities.
U.S. Orphan Drug and European Orphan Medicinal Product Designation and Exclusivity
The U.S. Orphan Drug Act provides incentives for the development of products intended to treat rare diseases or conditions, which are generally diseases or conditions that affect fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States for which there is no reasonable expectation that the cost of developing and making a drug or biologic available in the United States for this type of disease or condition will be recovered from sales of the product. Orphan designation must be requested and granted by the FDA before submitting a BLA. The benefits of orphan drug designation include research and development tax credits and exemption from FDA user fees. Orphan designation, however, does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
Under PREA, submission of a pediatric assessment is not typically required for pediatric investigation of a product that has been granted orphan drug designation. However, under the FDA Reauthorization Act of 2017, the scope of the PREA was extended to require pediatric studies for products intended for the treatment of an adult cancer that are directed at a molecular target that are determined to be substantially relevant to the growth or progression of a pediatric cancer. In addition, the FDA finalized guidance in 2018 indicating that it does not expect to grant any additional orphan drug designation to products for pediatric subpopulations of common diseases. Nevertheless, FDA intends to still grant orphan drug designation to a drug or biologic that otherwise meets all other criteria for designation when it prevents, diagnoses or treats either (i) a rare disease that includes a rare pediatric subpopulation, (ii) a pediatric subpopulation that constitutes a valid orphan subset, or (iii) a rare disease that is in fact a different disease in the pediatric population as compared to the adult population. Generally, if a product that receives orphan designation receives the first FDA approval for the orphan indication, the product is entitled to orphan drug exclusivity, which means that for seven years, the FDA is prohibited from approving any other applications to market the same drug or biological product for the same indication, except in limited circumstances. Orphan exclusivity does not block the approval of a different drug or biologic for the same rare disease or condition, nor does it block the approval of the same drug or biologic for different conditions. As a result, even if one of F-stars mAb2 product candidates receives orphan exclusivity, the FDA can still approve different drugs or biologics for use in treating the same indication or disease, which could create a more competitive market for F-star. Additionally, if a drug or biologic designated as an orphan product receives marketing approval for an indication broader than what was designated, it may not be entitled to orphan drug exclusivity.
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Orphan exclusivity will not bar approval of another product with the same drug or biologic for the same condition under certain circumstances, including if a subsequent product with the same drug or biologic for the same condition is shown to be clinically superior to the approved product on the basis of greater efficacy or safety or a major contribution to patient care, or if the company with orphan drug exclusivity cannot assure the availability of sufficient quantities of the drug or biologic to meet the needs of persons with the disease or condition for which the drug or biologic was designated.
After the FDA grants orphan designation, the identity of the applicant, as well as the name of the therapeutic agent and its designated orphan use, are disclosed publicly by the FDA.
Similarly, the European Commission grants orphan medicinal product designation to products intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating, affecting not more than five in 10,000 people in the European Union. In addition, orphan drug designation can be granted if the drug is intended for a life-threatening or chronically debilitating condition in the European Union and without incentives it is unlikely that returns from sales of the drug in the European Union would be sufficient to justify the investment required to develop the drug. In order to receive orphan designation, there must also be no satisfactory method of diagnosis, prevention or treatment of the condition, or if such a method exists, the medicine in question must be of significant benefit to those affected by the condition. In addition, sponsors are required to submit to the EMAs Pediatric Committee, and comply with a PIP, in order to initiate pivotal clinical investigation and seek marketing authorization in the European Union, unless the particular product is eligible for a deferral or waiver of the requirement to submit a PIP. The requirement to submit a PIP is waived for specific medicines or classes of medicines that are likely to be ineffective or unsafe in part or all of the pediatric population, are intended for conditions that occur only in adults or do not represent a significant therapeutic benefit over existing treatments for pediatric patients.
Designated orphan medicinal products are entitled to a range of incentives during the development and regulatory review process, including scientific assistance for study protocols, a partial or total reduction in fees and eligibility for conditional marketing authorization. Once authorized, orphan medicinal products are entitled to ten years of market exclusivity in all EU member states. However, marketing authorization may be granted to a similar medicinal product with the same orphan indication during the ten-year period with the consent of the marketing authorization holder for the original orphan medicinal product or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities of such product. Marketing authorization may also be granted to a similar medicinal product with the same orphan indication if the similar product is established to be safer, more effective or otherwise clinically superior to the original orphan medicinal product. An EU member state can request that the period of market exclusivity be reduced to six years if it can be demonstrated at the end of the fifth year of market exclusivity that the criteria for orphan designation no longer apply, such as where the medicine is sufficiently profitable. The period of market exclusivity may be extended for an additional two years for medicines that have also complied with an agreed PIP.
Pediatric Exclusivity
Pediatric exclusivity is another type of non-patent marketing exclusivity available in the United States and, if granted, it provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity for the approved drug or biological product. Under the Best Pharmaceuticals for Children Act (BPCA), certain therapeutic candidates may obtain an additional six months of exclusivity if the sponsor submits information requested in writing by the FDA, referred to as a Written Request, relating to the use of the active moiety of the product or therapeutic candidate in children. The data do not need to show the product to be effective in the pediatric population studied; rather, the additional protection is granted if the pediatric clinical study is deemed to have fairly responded to the FDAs Written Request. As part of the FDASIA in 2012, the United States Congress permanently reauthorized the BPCA in addition to the PREA.
Although the FDA may issue a Written Request for studies on either approved or unapproved indications, it may only do so where it determines that information relating to that use of a product or therapeutic candidate in a pediatric population, or part of the pediatric population, may produce health benefits in that population. The issuance of a Written Request does not require the sponsor to undertake the described studies. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application.
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U.S. Reference Product Exclusivity for Biological Products
The Biologics Price Competition and Innovation Act of 2009 (BPCIA), enacted as part of the Patient Protection and Affordable Care Act in March 2010, created a unique licensure framework for biosimilars in the United States, which could ultimately subject F-stars biological product candidates, if approved for marketing, to direct competition from potential future biosimilars. A biosimilar product is defined as one that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences between the follow-on biological product and the reference product in terms of the safety, purity and potency of the product. To date, the FDA has approved a number of biosimilars, and numerous biosimilars have been approved in Europe. The FDA has also issued several guidance documents outlining its approach to reviewing and approving biosimilars and interchangeable biosimilars.
Under the BPCIA, a manufacturer may submit an abbreviated application for licensure of a biologic that is biosimilar to or interchangeable with an FDA-licensed reference biological product. This abbreviated approval pathway is intended to permit a biosimilar to come to market more quickly and less expensively than if a full BLA were submitted, by relying to some extent on the FDAs previous review and approval of the reference biologic to which the proposed product is similar. Additionally, under the BPCIA, a biosimilar may be licensed as an interchangeable product upon a demonstration that the proposed product can be expected to produce the same clinical results as the reference product in any given patient, and, for products administered multiple times to an individual, that the product and the reference product may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biological product without such alternation or switch. Upon licensure by the FDA, an interchangeable biosimilar may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product, although to date no such products have been approved for marketing in the United States.
Under the abbreviated approval pathway, the biosimilar applicant must demonstrate that the product is biosimilar based on data from (1) analytical studies showing that the biosimilar product is highly similar to the reference product; (2) animal studies (including toxicity); and (3) one or more clinical studies to demonstrate safety, purity and potency in one or more appropriate conditions of use for which the reference product is approved. In addition, the applicant must show that the biosimilar and reference products have the same mechanism of action for the conditions of use on the label, route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity and potency.
A reference biological product is granted 12 years of data exclusivity from the time of first licensure of the product, and the first approved interchangeable biologic product will be granted an exclusivity period of up to one year after it is first commercially marketed. If pediatric studies are performed and accepted by the FDA as responsive to a Written Request, the 12-year exclusivity period will be extended for an additional six months.
In addition, the FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure of the reference product. First licensure typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available for) a supplement for the reference product for a subsequent application filed by the same sponsor or manufacturer of the reference product (or licensor, predecessor in interest or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength or for a modification to the structure of the biological product that does not result in a change in safety, purity or potency. Therefore, one must determine whether a new product includes a modification to the structure of a previously licensed product that results in a change in safety, purity or potency to assess whether the licensure of the new product is a first licensure that triggers its own period of exclusivity. Whether a subsequent application, if approved, warrants exclusivity as the first licensure of a biological product is determined on a case-by-case basis with data submitted by the sponsor.
The BPCIA is complex and only beginning to be interpreted and implemented by the FDA. As part of the Affordable Care Act, moreover, the future of the BPCIA is subject to uncertainty following a December 2019 Fifth Circuit Court of Appeals ruling that upheld a lower courts finding that the individual mandate in the
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Affordable Care Act is unconstitutional. The Fifth Circuit also reversed and remanded the case to the district court to determine if other reforms enacted as part of the Affordable Care Act but not specifically related to the individual mandate or health insurance, including the BPCIA, could be severed from the rest of the Affordable Care Act so as not to be declared invalid. On March 2, 2020, the United States Supreme Court granted the petitions for writs of certiorari to review this case and has allocated one hour for oral arguments, which are expected to occur in the fall, with a decision likely to follow in 2021. In addition, recent government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation and meaning of the BPCIA is subject to significant uncertainty.
Coverage, Pricing, and Reimbursement
In both domestic and foreign markets, sales of any products for which F-star may receive regulatory approval will depend in part upon the availability of coverage and adequate reimbursement from third-party payors. Coverage also may be more limited than the purposes for which the product is approved by the FDA or regulatory authorities in other countries. In the United States, such third-party payors include government health programs, such as Medicare and Medicaid, private health insurers and managed care providers and other organizations. Coverage decisions may depend upon clinical and economic standards that disfavor new drug and biological products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Assuming coverage is granted, the reimbursement rates paid for covered products might not be adequate and eligibility for reimbursement does not imply that any product will be paid for in all cases or at a rate that covers F-stars costs, including research, development, manufacture, sale and distribution. Interim payments for new products, if applicable, may also not be sufficient to cover F-stars costs and may not be made permanent. Even if favorable coverage status and adequate reimbursement rates are attained, less favorable coverage policies and reimbursement rates may be implemented in the future. The marketability of any products for which F-star may receive regulatory approval for commercial sale may suffer if the government and other third-party payors fail to provide coverage and adequate reimbursement to allow F-star to sell such products on a competitive and profitable basis. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs and biologics. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact physician utilization. For example, under these circumstances, physicians may limit how much or under what circumstances they will prescribe or administer F-stars future therapeutic products and patients may decline to purchase such products. This, in turn, could affect F-stars ability to successfully commercialize F-stars future therapeutic products and impact F-stars profitability, results of operations, financial condition, and future success.
The market for any mAb2 product candidates for which F-star may receive regulatory approval in the United States will depend significantly on the degree to which these products are listed on third-party payors drug formularies or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included on such formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payors may refuse to include a particular branded drug or biologic on their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent, biosimilar product, or other alternative is available. In addition, no uniform coverage and reimbursement policy exists and coverage and reimbursement can differ significantly from payor to payor. As such, one third-party payors determination to provide coverage does not assure that other third-party payors will also provide coverage. Third-party payors often rely on Medicare coverage policy and payment limitations in setting their own reimbursement rates but also have their own methods to individually establish coverage and reimbursement policies. As a result, obtaining coverage and adequate reimbursement can be a time-consuming and costly process. F-star may be required to provide scientific and clinical support for the use of any of its approved biological products to each third-party payor separately with no assurance that approval would be obtained, and F-star may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of F-stars future therapeutic products. F-star cannot be certain that F-stars mAb2 product candidates will be considered cost-effective by any private or government payors. This process could delay the market acceptance
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of any product candidates for which F-star may receive approval and could have a negative effect on F-stars future revenues and operating results.
In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. In some countries, the pricing of prescription pharmaceuticals is subject to government control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain coverage and adequate reimbursement or pricing approval in some countries, F-star may be required to conduct a clinical trial that compares the cost-effectiveness of F-stars product to other available therapies. Historically, therapeutic candidates launched in the European Union do not follow price structures of the United States and generally tend to be significantly lower.
Additionally, the containment of healthcare costs has become a priority of federal and state governments and the prices of therapeutics have been a focus in this effort. The United States government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic and biosimilar products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit F-stars future net revenue and operating results. In addition, companion diagnostic tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or biological products. Similar challenges to obtaining coverage and reimbursement for the pharmaceutical or biological products apply to companion diagnostics.
Anti-Kickback, False Claims, Physician Payments Sunshine and Other U.S. Healthcare Laws
In addition to FDA restrictions on marketing, several other types of U.S. state and federal laws are relevant to F-stars current and future business operations, including broadly applicable fraud and abuse and other healthcare laws, including the anti-kickback and false claims laws, privacy and security laws and transparency laws. F-star is subject to these laws or will become subject to them in the future, and they may affect F-stars business.
The U.S. federal Anti-Kickback Statute prohibits, among other things, any person or entity from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for an item of service, or the purchase, lease, order or recommendation of any good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs. The federal Anti-Kickback Statute is subject to evolving interpretations. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, formulary managers and other individuals and entities on the other hand, and the government has enforced the federal Anti-Kickback Statute to reach large settlements with healthcare companies based on sham consulting and other financial arrangements with physicians. A person or entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act, described below. There are a number of statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions; however, the exceptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exception or safe harbor may be subject to scrutiny.
The federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalty laws, prohibit, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to the U.S. government, or knowingly making, or causing to be made or used, a false record or statement material to a false or fraudulent claim to the U.S. government, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. government. Actions under these laws may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government. Many pharmaceutical and other healthcare companies have faced investigations and lawsuits, including those brought by individuals through qui tam actions, for a variety of allegedly improper promotional and marketing activities, including inflating drug prices they report to pricing services, which in turn were used by the
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government to set Medicare and Medicaid reimbursement rates; providing free product to customers with the expectation that the customers would bill federal programs for the product; providing consulting fees and other benefits to physicians to induce them to prescribe products; or engaging in promotion for off-label uses.
The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations (HIPAA), created new federal, civil and criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a criminal violation of these laws. HIPAA also imposes obligations on certain covered entity healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. The 2009 amendments to HIPAA makes the laws privacy and security standards directly applicable to business associates, defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. The amendments also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys fees and costs associated with pursuing federal civil actions.
The Physician Payments Sunshine Act, enacted as part of the Affordable Care Act in 2020 and implemented by the U.S. Department of Health and Human Services (HHS) as the Open Payments Program, among other things, requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Childrens Health Insurance Program to track payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists, chiropractors and, beginning in 2022 for payments and other transfers of value provided in the previous year, certain advanced non-physician healthcare practitioners) and teaching hospitals, as well as physician ownership and investment interests held by physicians and their immediate family members, and to publicly report such data to HHS. Manufacturers subject to the Open Payments Program must submit a report on or before the 90th day of each calendar year disclosing reportable payments made in the previous calendar year.
There are also analogous state laws and regulations, such as state anti-kickback and false claims laws, that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers or that apply regardless of payor. Several states now require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts and payments to individual healthcare providers in those states. Some of these states also prohibit certain marketing related activities including the provision of gifts, meals, or other items to certain healthcare providers. Some states also require pharmaceutical companies to implement compliance programs or marketing codes and report information on the pricing of certain drugs. Certain state and local laws also require the registration of pharmaceutical sales representatives,; and newly emerging state that govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, thus complicating compliance efforts.
Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory exemptions, it is possible that some of F-stars future business activities could be subject to challenge under one or more of such laws. If F-stars operations were found to be in violation of any of the federal or state laws described above or any other governmental regulations that apply to F-star, F-star may be subject to penalties, including significant criminal, civil monetary penalties, damages, disgorgement, fines, imprisonment, exclusion from participation in government programs, injunctions, recall or seizure of products, total or partial suspension
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of production, denial or withdrawal of pre-marketing product approvals, private qui tam actions brought by individual whistleblowers in the name of the government, additional reporting requirements and oversight if F-star become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of F-stars operations, any of which could adversely affect F-stars ability to operate F-stars business and F-stars results of operations.
To the extent that any of F-stars products are in the future sold in a foreign country, F-star may be subject to similar foreign laws and regulations, which may include, for instance, applicable anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.
U.S. Healthcare Reform
The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect F-stars ability to sell F-stars mAb2 product candidates profitably, even if they are approved for sale. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
In March 2010, the Affordable Care Act (ACA), was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The ACA, among other things, subjected biological products to potential competition by lower-cost biosimilars, created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers outpatient drugs to be covered under Medicare Part D.
Members of the U.S. Congress and the current administration have expressed intent to pass legislation or adopt executive orders to fundamentally change or repeal parts of the ACA, and since its enactment, there have been judicial and Congressional challenges to the law, and as a result certain sections have not been fully implemented or effectively repealed. In addition, the Tax Cuts and Jobs Act, repealed, effective January 1, 2019 (the TCJA), the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the individual mandate. On December 14, 2018, a federal district court in Texas ruled the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the TCJA, the remaining provisions of the ACA are invalid as well. The current administration and CMS have both stated that the ruling will have no immediate effect. On December 18, 2019, the Fifth Circuit U.S. Court of Appeals held that the individual mandate is unconstitutional, and remanded the case to the lower court to determine whether other reforms enacted as part of the ACA but not specifically related to the individual mandate or health insurance, including the provisions comprising the BPCIA, could be severed from the rest of the ACA so as not to be declared invalid as well. On March 2, 2020, the United States Supreme Court granted the petitions for writs of certiorari to review this case and has allocated one hour for oral arguments, which are expected to occur in the fall, with a decision likely to follow in 2021. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. F-star will continue to evaluate the effect that the ACA and its possible repeal and replacement has on its business. Complying with any new legislation or reversing changes implemented under the ACA could be time-intensive and expensive, resulting in a material adverse effect on F-stars business.
Other legislative changes have been proposed and adopted in the United States since the ACA that affect health care expenditures. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 and will remain in effect
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through 2030 unless additional Congressional action is taken. The Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) which was signed into law on March 27, 2020, designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030, in order to offset the added expense of the 2020 cancellation. Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Notably, on December 20, 2019, President Trump signed the Further Consolidated Appropriations Act for 2020 into law (P.L. 116-94) that includes a piece of bipartisan legislation called the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (the CREATES Act). The CREATES Act aims to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic and biosimilar product developers access to samples of brand products. Because generic and biosimilar product developers need samples to conduct certain comparative testing required by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic and biosimilar products. To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary samples on commercially reasonable, market-based terms. Whether and how generic and biosimilar product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on F-stars future commercial products are unknown.
On March 10, 2020, the Trump administration sent principles for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases. In addition, the Trump administration previously released a Blueprint to lower drug prices and reduce out of pocket costs of drugs that contained proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. The United States Department of Health and Human Services(HHS) has solicited feedback on some of these measures and implemented others under its existing authority. For example, in May 2019, HHS issued a final rule to allow Medicare Advantage plans the option to use step therapy for Part B drugs beginning January 1, 2020. This final rule codified an HHS policy change that was effective January 1, 2019. Additionally, in October 2018 President Trump announced a Medicare Part B payment proposal that will use HHS authority to test three new drug pricing measures to use international pricing as a metric, to develop a new competitive acquisition program, and to alter the average sales price model already in effect. As part of the Administrations Blueprint to lower drug prices, HHS and FDA also released on July 31, 2019 their Safe Importation Action Plan proposing two different pathways for the importation of foreign drug products. One pathway focuses on the importation of certain drugs from Canada, which will take time to implement because it will require the agencies to go through notice-and-comment rulemaking. FDAs notice of proposed rulemaking to implement a system whereby state governmental entities could lawfully import and distribute prescription drugs sourced from Canada was released at the end of December 2019. The second pathway would allow manufacturers to distribute their drugs manufactured abroad and it is unclear whether manufacturers will seek to take advantage of the second pathway, which was also released as a draft policy in December 2019. Both Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs making this area subject to ongoing uncertainty.
In addition, on May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new product candidates that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its product candidates
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available to eligible patients as a result of the Right to Try Act, although the FDA recently published a notice of proposed rulemaking that would require manufacturers who do so to make annual reports of those programs to FDA.
At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for F-stars products, once approved, or put pressure on F-stars product pricing.
F-star expects that these and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that F-star receive for any approved drug, which could have an adverse effect on customers for F-stars mAb2 product candidates. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.
There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The implementation of cost containment measures or other healthcare reforms may prevent F-star from being able to generate revenue, attain profitability, or commercialize F-stars products. Such reforms could have an adverse effect on anticipated revenue from mAb2 product candidates that F-star may successfully develop and for which F-star may obtain regulatory approval and may affect F-stars overall financial condition and ability to develop mAb2 product candidates.
Foreign Regulation
In addition to regulations in the United States, F-star will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of F-stars mAb2 product candidates. Whether or not F-star obtains FDA approval for a product candidate, F-star must obtain approval from the comparable regulatory authorities of foreign countries or economic areas, such as the European Union, before F-star may commence clinical trials or market products in those countries or areas. The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval.
In the European Union, for example, an application for a Clinical Trial Application (CTA), must be submitted to the competent national authority and an application made to an independent ethics committee in each country in which the trial is to be conducted, much like the FDA and IRB, respectively. Once the CTA is approved in accordance with a countrys requirements and a favorable ethics committee opinion has been issued, clinical trial development may proceed.
The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, the clinical trials are conducted in accordance with cGCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. To obtain regulatory approval of an investigational drug or biological product under EU regulatory systems, F-star must submit a marketing authorization application either under the so-called centralized or national authorization procedures.
Centralized procedure. The centralized procedure provides for the grant of a single marketing authorization by the European Commission following a favorable opinion by the EMA that is valid in all EU member states, as well as Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for medicines produced by specified biotechnological processes, products designated as orphan medicinal products and products with a new active substance indicated for the treatment of specified diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders or autoimmune diseases, other immune dysfunctions and viral diseases. The centralized procedure is optional for other products that represent a significant therapeutic, scientific or technical
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innovation, or whose authorization would be in the interest of patients in the EU or which contain a new active substance for indications other than those specified to be compulsory.
National authorization procedures. There are also three other possible routes to authorize medicinal products in several EU countries, which are available for investigational medicinal products that fall outside the scope of the centralized procedure:
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National procedure. Where a medicinal product falls outside the mandatory scope of the centralized procedure and is intended for marketing only in one EU member state, an application under the national procedure of that EU member state can be made. |
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Decentralized procedure. Using the decentralized procedure, an applicant may apply for simultaneous authorizations in more than one EU member state of medicinal products that have not yet been authorized in any EU member state and that do not fall within the mandatory scope of the centralized procedure. One EU states competent authority will act as the Reference Member State and prepare the initial assessment report. Once all competent authorities have agreed the assessment and the application is successful, each competent authority will issue an authorization for their jurisdiction. |
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Mutual recognition procedure. In the mutual recognition procedure, a medicine is first authorized in one EU member state, in accordance with the national procedures of that country. Following this, further marketing authorizations can be sought from other EU countries in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization. |
For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials are conducted in accordance with cGCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
If F-star or F-stars potential collaborators fail to comply with applicable foreign regulatory requirements, F-star may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
Other Regulations
F-star is also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. F-star may incur significant costs to comply with such laws and regulations now or in the future.
F-star is also subject to privacy laws in the jurisdictions in which F-star is established or in which F-star sell or market F-stars products or run clinical trials. For example, F-star and F-stars EU-based subsidiaries are subject to Regulation (EU) 2016/679, the General Data Protection Regulation (GDPR), in relation to F-stars collection, control, processing and other use of personal data (i.e., data relating to an identifiable living individual) to the extent that the activities are by a data controller or processor established in the EU or where the individuals who are being monitored are based in the EU. F-star process personal data in relation to participants in F-stars clinical trials, including the health and medical information of these participants. The GDPR is directly applicable in each EU member state, however, it provides that EU member states may introduce further conditions, including limitations which could limit F-stars ability to collect, use and share personal data (including health and medical information), or could cause F-stars compliance costs to increase, ultimately having an adverse impact on F-stars business. The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data processing and implement policies as part of its mandated privacy governance framework. It also requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and easily accessible form) how their personal information is to be used; imposes limitations on retention of personal data; defines for the first time pseudonymized (i.e., key-coded) data; introduces mandatory data breach notification requirements; and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities. F-star is also subject to
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EU rules with respect to cross-border transfers of personal data out of the European Union and European Economic Area. F-star is subject to the supervision of local data protection authorities in those EU jurisdictions where F-star is established or otherwise subject to the GDPR. Fines for certain breaches of the GDPR can be significant: up to the greater of 20 million or 4% of total global annual turnover. In addition to the foregoing, a breach of the GDPR or other applicable privacy and data protection laws and regulations could result in regulatory investigations, reputational damage, orders to cease/ change F-stars use of data, enforcement notices, or potential civil claims including class action type litigation.
Employees
As of September 15, 2020, F-star had 75 full-time employees and five part-time employees, 77 are located in the United Kingdom and three in the United States. None of F-stars employees is subject to a collective bargaining agreement or represented by a trade or labor union. F-star considers its relationship with its employees to be good.
Facilities
F-stars principal offices occupy approximately 13,554 square feet of leased office, research and development and laboratory facility space in Cambridge, United Kingdom, pursuant to a lease agreement that expires in 2021. F-star also has an office agreement with Regus Management Group, LLC in Cambridge, Massachusetts, pursuant to a rolling lease agreement that expires in 2020. F-star believes that its current facilities are suitable and adequate to meet its current needs.
Legal Proceedings
From time to time, F-star may become involved in legal proceedings or be subject to claims arising in the ordinary course of its business. F-star is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal proceeding against it that it believes could have a material adverse effect on F-stars business, operating results or financial condition. Regardless of the outcome, litigation can have an adverse impact on F-star because of defense and settlement costs, diversion of management resources and other factors.
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SPRING BANK MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following information should be read in conjunction with the audited and unaudited financial information of Spring Bank and the notes thereto included elsewhere in this proxy statement/prospectus.
Overview
Spring Bank is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of a range of cancers and inflammatory diseases using its proprietary small molecule nucleotide platform. Spring Bank designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. Spring Banks internally-developed programs are primarily designed to stimulate and/or dampen immune responses. Spring Bank is devoting its resources to advancing multiple programs in its STING product portfolio, including its STING agonist clinical program in oncology, its STING antagonist compounds for inflammatory diseases, and its STING agonist antibody drug conjugate (ADC) program for oncology.
Until January 2020, Spring Bank had been developing inarigivir soproxil, an investigational orally-administered RIG-I agonist compound, as a potential treatment for chronic HBV. In April 2019, Spring Bank launched two Phase 2 global trials (CATALYST 1 and CATALYST 2) examining the administration of inarigivir 400mg as monotherapy and co-administered with a nucleotide in naïve and virally suppressed chronic HBV patients. On January 29, 2020, Spring Bank announced that it is terminating all clinical development of inarigivir for the treatment of HBV due to the occurrence of unexpected serious adverse events, including one patient death, in its Phase 2b CATALYST 2 trial.
Spring Bank Development Programs
The pandemic caused by COVID-19 (the COVID-19 pandemic) that is affecting the U.S. and global economy and financial markets is also impacting its employees, patients, communities and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact Spring Banks business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. Management is actively monitoring this situation and the possible effects on Spring Banks financial condition, liquidity, operations, suppliers, industry, and workforce. In the paragraphs that follow, Spring Bank has described impacts of the COVID-19 pandemic on its clinical and preclinical development programs.
Spring Bank is developing its lead STING agonist product candidate, SB 11285, as a next-generation immunotherapeutic agent for the treatment of selected cancers. SB 11285 is currently being evaluated as an intravenously (IV)-administered monotherapy in a Phase 1a/1b multicenter, dose escalation clinical trial in patients with advanced solid tumors. Phase 1a of this trial is a dose-escalation study with IV SB 11285 monotherapy which allows combination with a checkpoint inhibitor after the completion of the first two cohorts of the trial. Phase 1b of this trial is designed to explore IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in tumor types expected to be responsive to immunotherapy. In February 2020, Spring Bank entered into a clinical collaboration with Roche for the use of Roches PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in the combination cohorts of this trial.
Spring Bank initiated dosing in the initial monotherapy cohort of this Phase 1 trial in the fourth quarter of 2019 and has since completed two additional dose-escalating monotherapy cohorts. In August 2020, Spring Bank initiated the first combination cohort of this Phase 1 trial examining the co-administration of SB 11285 and atezolizumab. Although several of the institutions involved in the conduct of this trial have suspended patient enrollment in all of their clinical trials due to the COVID-19 pandemic, Spring Bank has been able to continue dosing patients in this trial at two key sites and just recently completed the dosing of patients in the third cohort. Depending on whether Spring Bank is able to continue enrolling and dosing patients in this Phase 1 trial, it plans to complete the fourth monotherapy cohort by the end of the third or early fourth quarter of 2020. Spring Bank anticipates that it will announce monotherapy data in the fourth quarter of 2020 and generate sufficient data from
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its Phase 1a/1b IV STING agonist program by the end of the first half of 2021 to enable advancement into a Phase 2 clinical trial. While the company currently anticipates this Phase 1 trial will remain open and currently enrolled patients will continue on study, all clinical sites activated for the study may determine to stop enrolling and/or dosing patients as a result of the impact of the COVID-19 pandemic, which has the potential to impact both the advancement into combination cohorts and the availability of data in 2020 and the first half of 2021.
ADCs represent a novel platform to enable the targeted delivery of payload molecules. Conjugation of a payload molecule to an antibody that has its own efficacy profile could allow for a single drug with enhanced potency and safety compared to either mechanism alone. Spring Bank believes the chemistry used to develop its STING agonists is differentiated from first generation STING agonists because preclinical studies have shown that its molecules allow for site-specific conjugation to other therapeutic modalities, including antibodies, to form ADCs. Spring Banks STING agonists, in combination with an antibody to form an ADC, could provide targeted delivery to the tumor site to better achieve anti-tumor efficacy.
Spring Bank is also exploring the use of its novel STING antagonist compounds for the treatment of certain autoimmune and inflammatory diseases where the STING pathway is involved. Spring Banks STING antagonists are selectively designed to block aberrant activation of the STING pathway, which contributes to the causes of certain autoimmune and inflammatory diseases, including STING-associated vasculopathy with onset in infancy (SAVI), systemic lupus erythematosus (SLE) and other proinflammatory-mediated diseases. In July 2019, Spring Bank presented preclinical data from a novel STING antagonist compound, which showed potent inhibition of interferon and pro-inflammatory cytokines in wild type and mutant STING in vitro models. In vivo administration of this compound antagonized STING-agonist-induced interferon and cytokine production in the blood, spleen and liver in mice, illustrating the potential that this compound has for therapeutic applications in interferonopathies, as well as autoimmune and inflammatory diseases. Furthermore, in August 2019, Spring Bank entered into a research agreement with the University of Texas Southwestern Medical School to evaluate its small molecule STING antagonist compounds. Spring Bank hopes to initiate IND-enabling activities for its lead, orally-available STING antagonist product candidate, SB 11736, in early 2021.
In April 2020, Spring Bank announced that it is exploring programs and collaborations to study its portfolio of RIG-I agonist and STING agonist compounds as potential therapeutics and vaccine adjuvants for SARS-CoV-2, the virus responsible for COVID-19. Spring Bank is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to examine multiple compounds from its RIG-I agonist and STING agonist portfolio in the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) assay and the SARS-CoV-2 antiviral assay. Spring Bank is also pursuing the inclusion of inarigivir, a RIG-I agonist, as an adjuvant therapy in ongoing clinical trials involving Bacille Calmette-Guerin (BCG) vaccines against SARS-CoV-2.
To date, Spring Bank has devoted substantially all of its resources to research and development efforts, including conducting clinical trials for its product candidates, protecting its intellectual property and providing general and administrative support for these operations. Spring Bank has not generated any revenue to date other than from grants from the NIH. No additional funding remains available to Spring Bank under any grant for the development of any of its product candidates. Spring Bank has funded its operations primarily through proceeds received from private placements of convertible notes, common stock and/or warrants; the exercise of options and warrants; NIH grant funding; and public offerings of securities.
Spring Bank has incurred significant annual net operating losses in every year since its inception and expects to continue to incur significant expenses and net operating losses for the foreseeable future. Spring Banks net losses for the three and six months ended June 30, 2020 were $6.5 million and $14.7 million, respectively, and its net losses for the three and six months ended June 30, 2019 were $4.6 million and $9.8 million, respectively. As of June 30, 2020, Spring Bank had an accumulated deficit of $140.9 million. Spring Banks net losses may fluctuate significantly from quarter to quarter and year to year. Spring Bank expects to continue to incur significant expenses and increasing operating losses for the next several years.
Spring Bank does not expect to raise any additional funds prior to the completion of the Exchange. However, if the Exchange is not completed, Spring Bank may require significant additional funds earlier than it
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currently expects in order to conduct clinical trials and preclinical and discovery activities. There can be no assurances, however, that additional funding will be available on favorable terms, or at all. To the extent that Spring Bank raises additional capital through the sale of equity or convertible debt securities, stockholders ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect common stockholder rights. If Spring Bank raises additional funds through collaborations, strategic alliances or licensing arrangements with third parties, Spring Bank may have to relinquish valuable rights to its technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to Spring Bank.
There is no guarantee that the Exchange will be completed. As of June 30, 2020, Spring Bank had $23.5 million in cash, cash equivalents and marketable securities. Spring Bank expects that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund operations for at least the next twelve months. This estimate assumes no additional funding from new collaboration agreements, equity financings or further sales under Spring Bank Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co.
Financial Operations Overview
Operating expenses
Spring Banks operating expenses since inception have consisted primarily of research and development expense and general and administrative costs.
Research and development
Research and development expenses consist primarily of costs incurred for Spring Banks research activities, including its discovery efforts, and the development of its product candidates, which include:
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expenses incurred under agreements with third parties, including CROs that conduct research, preclinical activities and clinical trials on its behalf as well as contract manufacturing organizations (CMOs), that manufacture drug products for use in its preclinical and clinical trials; |
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salaries, benefits and other related costs, including stock-based compensation expense, for personnel in its research and development functions; |
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costs of outside consultants, including their fees, stock-based compensation and related travel expenses; |
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the cost of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials; |
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costs related to compliance with regulatory requirements; and |
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facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. |
Spring Bank expenses research and development costs as incurred. Spring Bank recognizes external development costs based on an evaluation of the progress to completion of specific tasks using information provided to Spring Bank by its vendors and its clinical investigative sites. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in its consolidated financial statements as prepaid or accrued research and development expenses.
Spring Bank directs research and development expenses are not currently tracked on a program-by-program basis. Until January 2020, Spring Bank was primarily focused on the research and development of inarigivir. Going forward, and at least until the completion of the Exchange, Spring Bank expects its primary focus to be on the research and development of compounds targeting the STING pathway. Spring Banks direct research and development expenses consist primarily of external costs, such as fees paid to investigators, consultants and CROs in connection with its preclinical studies and clinical trial and regulatory fees. Spring Bank does not allocate employee-related costs and other indirect costs to specific research and development programs.
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The successful development of its product candidates is highly uncertain. Accordingly, at this time, Spring Bank cannot reasonably estimate the nature, timing and costs of the efforts that will be necessary to complete the development of any of its product candidates. Spring Bank is also unable to predict when, if ever, it will generate revenues from SB 11285 or any of its other product candidates. This is due to the numerous risks and uncertainties associated with developing medicines, including the uncertainties related to:
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establishing an appropriate safety profile for its product candidates; |
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successful enrollment in and completion of clinical trials; |
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receipt of marketing approvals from applicable regulatory authorities; |
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establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; |
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obtaining and maintaining patent and trade secret protection and regulatory exclusivity for its product candidates; |
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launching commercial sales of the products, if and when approved, whether alone or in collaboration with others; and |
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if a product is approved, a continued acceptable safety profile of the product. |
A change in the outcome of any of these variables with respect to any of its product candidates would significantly change the costs and timing associated with the development of that product candidate.
Spring Bank anticipates its research and development expenses will trend below comparable prior period levels in the near future as a result of reduced research and development activities and a reduced headcount of research and development personnel.
General and administrative
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in its executive, finance, corporate and business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
Spring Bank anticipates its general and administrative expenses will remain consistent with comparable prior period levels in the near future. Spring Bank will continue to incur expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, and investor and public relations costs.
Other income (expense)
Other income (expense) consists of interest income earned on its cash, cash equivalents, restricted cash and marketable securities, interest expense paid on a convertible term loan with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders (the Convertible Term Loan) and the loss on extinguishment of debt for repayment of the Convertible Term Loan.
Change in fair value of warrant liabilities
Change in fair value of warrant liabilities consists of a gain or (loss) related to the change in the fair value of the warrants issued in connection with its private placement offering in November 2016, resulting from factors such as a change in its stock price and a change in expected stock price volatility.
Critical Accounting Policies and Significant Judgments and Estimates
Spring Banks consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States of America. The preparation of its consolidated financial statements
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and related disclosures requires its management to make estimates and assumptions that affect the reported amount of assets, liabilities, revenue, costs and expenses and related disclosures. Spring Bank believes that the estimates and assumptions underlying the accounting policies described therein may have the greatest potential impact on its consolidated financial statements and, therefore, consider these to be its critical accounting policies. Spring Bank evaluates its estimates and assumptions on an ongoing basis. Spring Banks actual results may differ from these current estimates based on different assumptions and under different conditions.
Accrued Research and Development Expenses
As part of the process of preparing its consolidated financial statements, Spring Bank is required to estimate its accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with its personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the services when Spring Bank has not yet been invoiced or otherwise notified of the actual costs. The majority of its service providers invoice Spring Bank in arrears for services performed, on a predetermined schedule or when contractual milestones are met; however, some require advanced payments. Spring Bank makes estimates of its accrued expenses as of each balance sheet date in its consolidated financial statements based on facts and circumstances known to it at that time. Examples of estimated accrued research and development expenses include fees paid to:
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CROs in connection with performing research services on its behalf and clinical trials; |
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investigative sites or other providers in connection with clinical trials; |
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vendors in connection with preclinical and clinical development activities; and |
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vendors related to product manufacturing, development and distribution of preclinical and clinical supplies. |
Spring Bank bases its expenses related to preclinical studies and clinical trials on its estimates of the services received and efforts expended pursuant to quotes and contracts with multiple CROs that conduct and manage clinical trials on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to its vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, Spring Bank estimates the time period over which services will be performed, enrollment of patients, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, Spring Bank adjusts the accrual or amount of prepaid expense accordingly. Although Spring Bank does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low in any particular period. To date, Spring Bank has not made any material adjustments to its prior estimates of accrued research and development expenses.
Warrants Issued in 2016 Private Placement
In connection with its private placement offering in November 2016 (the November private placement), Spring Bank issued warrants to purchase 1,644,737 shares of common stock, (the November 2016 Warrants). These warrants are exercisable at an exercise price of $10.79 per share. Spring Bank evaluated the terms of these warrants and concluded that they should be liability-classified. In November 2016, Spring Bank recorded the fair value of these warrants of approximately $8.3 million. Spring Bank recognizes any change in the value of the warrant liability each reporting period in the statement of operations. As of June 30, 2020, the fair value of the warrants was approximately $38,000, which is a decrease of approximately $261,000 from the fair value of approximately $299,000 as of December 31, 2019.
Stock-Based Compensation
Spring Bank issues stock-based awards to employees and non-employees, generally in the form of stock options or performance-based restricted stock units. Spring Bank accounts for its stock-based compensation
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awards in accordance with Financial Accounting Standards Board, (FASB) ASC Topic 718, CompensationStock Compensation (ASC 718). ASC 718 requires all stock-based payments to employees and non-employees, including grants of employee stock options and modifications to existing stock awards, to be recognized in the statements of operations and comprehensive loss based on their fair values.
Spring Bank measures stock options and other stock-based awards granted to employees, nonemployees and directors based on the fair value on the date of grant and recognize the corresponding compensation expense of those awards, over the requisite service period, which is generally the vesting period of the respective award. Spring Bank accounts for forfeitures as they occur. Generally, Spring Bank issues stock options and performance based restricted stock units with service-based vesting conditions and record the expense for these awards using the straight-line method. Each quarter Spring Bank updates its assessment of the probability that the specified performance criteria will be achieved and adjust its estimate of the fair value of the performance-based restricted stock units (performance-based RSUs) if necessary.
Spring Bank estimates the fair value of each stock option grant using the Black-Scholes option-pricing model. Use of this model requires that Spring Bank makes assumptions as to the fair value of its common stock, the volatility of its common stock, the expected term of its stock options, the risk-free interest rate for a period that approximates the expected term of its stock options and its expected dividend yield. Because Spring Bank lacks company-specific historical and implied volatility information due in part to the limited time in which Spring Bank has operated as a publicly traded company, Spring Bank estimates its expected volatility based on the historical volatility of a group of publicly traded peer companies. Spring Bank expects to continue to do so until such time as it has adequate historical data regarding the volatility of its traded stock price. Spring Bank uses the simplified method prescribed by the SECs Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term of options granted to employees and directors. Spring Bank bases the expected term of options granted to consultants and nonemployees on the contractual term of the options. Spring Bank determines the risk-free interest rate by reference to the United States Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that Spring Bank has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
Spring Bank recognizes forfeitures as they occur and the compensation expense is reversed in the period that the forfeiture occurs. The assumptions Spring Bank used to determine the fair value of granted stock options in six months ended June 30, 2020 and 2019 are as follows:
For the
Six Months Ended June 30, |
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2020 | 2019 | |||||||
Risk-free interest rate |
0.7 | % | 2.6 | % | ||||
Expected term (in years) |
5.9 | 6.0 | ||||||
Expected volatility |
82.8 | % | 81.1 | % | ||||
Expected dividend yield |
0 | % | 0 | % |
The assumptions used to determine the fair value of the time-based RSUs granted to management during the six months ended June 30, 2020 is based on the market price of the award on the grant date, which was a weighted average fair value for the six months ended June 30, 2020 of $1.41 per share.
These assumptions represent its best estimates, but the estimates involve inherent uncertainties and the application of its judgment. As a result, if factors change and Spring Bank uses significantly different assumptions or estimates, its stock-based compensation expense could be materially different. Spring Bank recognizes compensation expense for only the portion of awards that are expected to vest.
The impact of its stock-based compensation expense for stock options and performance based restricted stock units granted to employees and non-employees may grow in future periods if the fair value of its common stock increases.
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The following table summarizes the classification of its stock-based compensation expenses recognized in its consolidated statements of operations and comprehensive loss (in thousands):
For the
Three Months Ended June 30, |
For the
Six Months Ended June 30, |
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Stock-based compensation: |
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Research and development |
$ | 171 | $ | 339 | $ | 446 | $ | 656 | ||||||||
General and administrative |
303 | 702 | 845 | 1,357 | ||||||||||||
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Total Stock-based compensation |
$ | 474 | $ | 1,041 | $ | 1,291 | $ | 2,013 | ||||||||
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JOBS Act
In April 2012, the Jumpstart Our Business Startups Act of 2012 (the JOBS Act), was enacted. Section 107 of the JOBS Act provides that an emerging growth company, (EGC), can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (the Securities Act), for complying with new or revised accounting standards. Thus, as an EGC, Spring Bank could have delayed the adoption of certain accounting standards until those standards would otherwise apply to private companies. However, Spring Bank irrevocably elected not to avail itself of this extended transition period and, as a result, Spring Bank will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
Subject to certain conditions, as an EGC, Spring Bank intends to rely on certain exemptions afforded by the JOBS Act, including the exemption from certain requirements related to the disclosure of executive compensation in its periodic reports and proxy statements, and the requirement that Spring Bank holds a nonbinding advisory vote on executive compensation and any golden parachute payments; the requirement that the auditors provide an attestation report on its system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; and complying with any requirement that may be adopted by the Public Company Accounting Oversight Board, (PCAOB), regarding mandatory audit firm rotation or a supplement to the auditors report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. Spring Bank will remain an EGC until the earliest of the last day of the fiscal year in which Spring Bank has total annual gross revenues of approximately $1.07 billion or more; the last day of the fiscal year following the fifth anniversary of the date of the completion of the closing of its initial public offering (IPO), which is December 31, 2021; the date on which Spring Bank has issued more than $1 billion in nonconvertible debt during the previous three years; or the date on which it is deemed to be a large accelerated filer under the rules of the SEC.
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Results of Operations
Comparison of the Three and Six Months Ended June 30, 2020 and 2019
The following table summarizes its results of operations for the three and six months ended June 30, 2020 and 2019 (in thousands):
For the
Three Months Ended June 30, |
Change |
For the
Six Months Ended June 30, |
Change | |||||||||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||||||||||
Operating expenses: |
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Research and development |
$ | 3,204 | $ | 7,275 | $ | (4,071 | ) | $ | 8,507 | $ | 12,842 | $ | (4,335 | ) | ||||||||||
General and administrative |
2,164 | 2,490 | (326 | ) | 5,043 | 5,300 | (257 | ) | ||||||||||||||||
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Total operating expenses |
5,368 | 9,765 | (4,397 | ) | 13,550 | 18,142 | (4,592 | ) | ||||||||||||||||
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Loss from operations |
(5,368 | ) | (9,765 | ) | 4,397 | (13,550 | ) | (18,142 | ) | 4,592 | ||||||||||||||
Other income (expense) |
(1,198 | ) | 325 | (1,523 | ) | (1,433 | ) | 686 | (2,119 | ) | ||||||||||||||
Change in fair value of warrant liabilities |
22 | 4,885 | (4,863 | ) | 261 | 7,706 | (7,445 | ) | ||||||||||||||||
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Net loss |
$ | (6,544 | ) | $ | (4,555 | ) | $ | (1,989 | ) | $ | (14,722 | ) | $ | (9,750 | ) | $ | (4,972 | ) | ||||||
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Research and development expenses.
Research and development expenses during the three months ended June 30, 2020 and 2019 were $3.2 million and $7.3 million, respectively. The decrease of $4.1 million during the three months ended June 30, 2020 was primarily due to a decrease in spending on preclinical and clinical trial-related activities for inarigivir and manufacturing costs for inarigivir and SB 11285 of $3.6 million, as well as other research and development related expenses of $0.5 million, including laboratory supplies, salaries and benefits costs and non-cash charges for stock-based compensation.
Research and development expenses during the six months ended June 30, 2020 and 2019 were $8.5 million and $12.8 million, respectively. The decrease of $4.3 million during the six months ended June 30, 2020 was primarily due to a decrease in spending on preclinical studies and clinical trial-related activities for inarigivir and manufacturing costs for inarigivir and SB 11285 of $3.8 million, as well as other research and development related expenses of $0.5 million, including laboratory supplies, salaries and benefits costs and non-cash charges for stock-based compensation.
General and administrative expenses.
General and administrative expenses during the three months ended June 30, 2020 and 2019 were $2.2 million and $2.5 million, respectively. The decrease of $0.3 million during the three months ended June 30, 2020 was primarily due to a decrease in non-cash stock-based compensation of $0.4 million, offset by insurance costs of $0.1 million.
General and administrative expenses during the six months ended June 30, 2020 and 2019 were $5.0 million and $5.3 million, respectively. The decrease of $0.3 million during the six months ended June 30, 2020 was primarily due to an decrease in non-cash charges for stock-based compensation of $0.5 million and legal-related costs of $0.2 million, offset by other general and administrative related expenses of $0.4 million, including consulting-related costs and public company related costs.
Other income (expense). Other income (expense) during the three and six months ended June 30, 2020 and 2019 is comprised of interest income, offset by interest expense and loss on extinguishment of debt. Interest income during the three and six months ended June 30, 2020 was approximately $44,000 and $285,000, respectively, and was primarily related to the interest earned on marketable securities. Interest expense during the three and six months ended June 30, 2020 was approximately $35,000 and $511,000, respectively, and was due to the interest expense incurred on the Convertible Term Loan. Loss on extinguishment of debt during the three and six months ended June 30, 2020 was approximately $1.2 million during both periods and was due to the
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repayment of the Convertible Term Loan. Interest income during the three and six months ended June 30, 2019 was approximately $325,000 and approximately $686,000, respectively, and was primarily due to the interest earned on marketable securities. There was no interest expense and no loss on extinguishment of debt as of June 30, 2019.
Change in fair value of warrant liabilities. The change in fair value of warrant liabilities during the three and six months ended June 30, 2020 was a gain of approximately $22,000 and $261,000, respectively. The change in fair value of warrant liabilities during the three and six months ended June 30, 2019 was a gain of $4.9 million and $7.7 million, respectively. The change in value each period was solely due to the change in the fair value of the November 2016 Warrants, primarily as a result of the change in its stock price and stock price volatility.
Liquidity and Capital Resources
Sources of Liquidity
From its inception through June 30, 2020, Spring Bank has financed its operations through proceeds received from private placements of convertible notes, common stock and/or warrants, the exercise of options and warrants, NIH grant funding and public offerings of securities. As of June 30, 2020, Spring Bank had cash, cash equivalents and marketable securities totaling $23.5 million and an accumulated deficit of $140.9 million.
In August 2017, Spring Bank entered into a Controlled Equity OfferingSM Sales Agreement (Sales Agreement), with Cantor Fitzgerald & Co. (Cantor), pursuant to which Spring Bank may offer and sell, from time to time through Cantor, shares of its common stock having an aggregate offering price of up to $50.0 million. Spring Bank pays Cantor a commission rate equal to 3.0% of the aggregate gross proceeds from each sale. Shares sold under the Sales Agreement were offered and sold pursuant to its Registration Statement on Form S-3 (Registration No. 333-218399) that was declared effective by the SEC on June 12, 2017 (S-3 Registration Statement), and a prospectus supplement and accompanying base prospectus that it filed with the SEC on August 18, 2017. The S-3 Registration Statement expired June 12, 2020, and no further shares of Spring Bank common stock may be sold under the Sales Agreement. During the three and six months ended June 30, 2020, Spring Bank sold an aggregate of 649,095 and 690,895 shares of its common stock, respectively, pursuant to the Sales Agreement at a weighted-average selling price of $1.32 per share, during both periods, which resulted in approximately $0.8 million in net proceeds to the Company during both periods. During the year ended December 31, 2019, Spring Bank sold an aggregate of 600 shares of its common stock under the Sales Agreement at a weighted average selling price of $10.03 per share, which resulted in de minimis net proceeds.
In September 2019, Spring Bank entered into a loan and security agreement with certain affiliates of Pontifax Medison Finance (Lenders), that provided for a $20.0 million term loan and bears annual interest at a rate of 8.0% (the Convertible Term Loan). The Convertible Term Loan provided for interest-only payments for twenty-four months and repayment of the aggregate outstanding principal balance of the loan in quarterly installments starting upon expiration of the interest only period and continuing through September 19, 2023. The Lenders could have, at their option, elected to convert some or all of the then outstanding term loan amount and all accrued and unpaid interest thereon into shares of its common stock at a conversion price of $8.76 per share.
On April 8, 2020, Spring Bank entered into a prepayment notice and pay-off letter with the Lenders, which provided for the full repayment in cash on April 8, 2020 of its $20.0 million Convertible Term Loan. The pay-off letter provided that the repayment amount would be approximately $20.3 million, which included payment in full of all outstanding principal and accrued interest underlying the Convertible Term Loan and $0.3 million for a prepayment fee. Pursuant to the pay-off letter, all of its indebtedness and obligations to the Lenders were discharged in full, and all security interests and other liens held by the Lenders as security for the Convertible Term Loan terminated upon the Lenders receipt of the repayment amount. In connection with the repayment of the Convertible Term Loan, the warrants previously issued to the lenders were amended and restated so that the new exercise price is $2.08, which was equal to 1.5 times the weighted-average closing price of its common stock during the 90 days prior to the repayment date and resulted in an incremental expense of approximately $54,000. All other terms and conditions of the Pontifax Warrants remain the same.
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Spring Bank made the decision to repay the Convertible Term Loan as a result of changes in its operating needs following its announcement in the first quarter of 2020 that Spring Bank was discontinuing the development of its HBV program, as well as the cost of capital associated with the Convertible Term Loan.
Cash Flows
The following table summarizes sources and uses of cash for each of the periods presented (in thousands):
For the
Six Months Ended June 30, |
||||||||
2020 | 2019 | |||||||
Net cash used in operating activities |
$ | (11,961 | ) | $ | (14,765 | ) | ||
Net cash provided by investing activities |
11,234 | 10,582 | ||||||
Net cash (used in) provided by financing activities |
(19,451 | ) | 6 | |||||
|
|
|
|
|||||
Net decrease in cash, cash equivalents and restricted cash |
$ | (20,178 | ) | $ | (4,177 | ) | ||
|
|
|
|
Net cash used in operating activities. The use of cash in both periods resulted primarily from its net losses adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activities during the six months ended June 30, 2020 and 2019 was $12.0 million and $14.8 million, respectively. The decrease in cash used in operating activities during the six months ended June 30, 2020 compared to six months ended June 30, 2019 of $2.8 million was primarily due to a decrease in the non-cash change in the fair value of the warrant liability of $7.4 million, non-cash change in stock-based compensation of $0.7 million and prepaid expense and other current assets of $1.5 million, offset by an increase in net loss of $4.9 million, loss on extinguishment of debt of $1.2 million and accrued expenses and other current and non-current liabilities of $1.7 million.
Net cash provided by investing activities. Net cash provided by investing activities during the six months ended June 30, 2020 and 2019 was $11.2 million and $10.6 million, respectively. The cash provided by investing activities during the six months ended June 30, 2020 was primarily the result of $32.2 million in proceeds from the sale of marketable securities, which was offset by $21.0 million for the purchase of marketable securities. The cash used in investing activities during the six months ended June 30, 2019 was primarily the result of $16.8 million in proceeds from the sale of marketable securities, which was offset by $6.0 million for the purchase of marketable securities and $0.2 million for the purchase of property and equipment.
Net cash (used in) provided by financing activities. Net cash used in financing activities during the six months ended June 30, 2020 was $19.5 million and net cash provided by financing activities during the six months ended June 30, 2019 was approximately $6,000. Net cash used in financing activities during the six months ended June 30, 2020 was primarily the result of $20.3 million for payment of the Convertible Term Loan and prepayment charge, offset by $0.8 million of net proceeds from its at-the-market offering program under the Sales Agreement. Net cash provided by financing activities during the six months ended June 30, 2019 was the result of net proceeds from its at-the-market offering program under the Sales Agreement.
Funding Requirements
As of June 30, 2020, Spring Bank had $23.5 million in cash, cash equivalents and marketable securities. Spring Bank expects that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund operations for at least the next twelve months. This estimate assumes no additional funding from new collaboration agreements, equity financings or further sales under its Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co.
Spring Banks future capital requirements as a stand-alone company, if the proposed Exchange were not to be completed, are difficult to forecast. Spring Banks future funding requirements will depend on many factors, including, but not limited to:
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the continued clinical development of SB 11285, its lead STING agonist product candidate; |
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the costs involved in conducting preclinical and clinical activities for its STING and COVID-19 programs; |
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the costs of preparing, filing, and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; |
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the extent to which it may elect to continue product development activities in the future, if at all; and |
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the timing and completion of the Exchange. |
Spring Bank does not expect to raise any additional funds prior to the completion of the Exchange. However, if the Exchange is not completed, Spring Bank may require significant additional funds earlier than it currently expects in order to conduct clinical trials and preclinical and discovery activities. Because of the numerous risks and uncertainties associated with the development and commercialization of its product candidates, Spring Bank is unable to estimate the amounts of increased capital outlays and operating expenditures associated with future research and development activities.
To the extent the Exchange is not completed and its capital resources are insufficient to meet its future operating and capital requirements, Spring Bank will need to finance its future cash needs through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements. However, additional funding may not be available to Spring Bank on acceptable terms or at all, and its ability to obtain funding may be adversely affected by the uncertainty and volatility in the U.S. capital markets relating to the ongoing COVID-19 pandemic. In addition, the terms of any financing may adversely affect the holdings or the rights of its stockholders. For example, if Spring Bank raises additional funds by issuing equity securities or by selling convertible debt securities, further dilution to its existing stockholders may result. In addition, pursuant to the instructions to Form S-3, if Spring Bank files a new S-3 shelf registration statement, Spring Bank would only have the ability to sell shares under such registration statement, during any 12-month period, in an amount less than or equal to one-third of the aggregate market value of its common stock held by non-affiliates, which is commonly referred to as its public float. If adequate funds are not available, Spring Bank may be required to obtain funds through collaborators that may require it to relinquish rights to its technologies or drug candidates that it might otherwise seek to develop or commercialize independently.
Contractual Obligations and Commitments
In September 2019, Spring Bank entered into the Convertible Term Loan with the Lenders that provided for a $20.0 million term loan with an annual interest rate of 8.0%. The Convertible Term Loan provided for interest-only payments for twenty-four months and repayment of the aggregate outstanding principal balance of the term loan in quarterly installments starting upon expiration of the interest only period and continuing through September 19, 2023. On April 8, 2020, Spring Bank entered into a prepayment notice and pay-off letter with the Lenders, which provided for the full repayment in cash on April 8, 2020 of the Convertible Term Loan. Pursuant to the pay-off letter, all of its indebtedness and obligations to the Lenders were discharged in full, and all security interests and other liens held by the Lenders as security for the Loan terminated upon the Lenders receipt of the repayment amount.
Spring Bank enters into contracts in the normal course of business with third party service providers for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. Spring Bank has not included its payment obligations under these contracts in the table as these contracts generally provide for termination upon notice, and therefore, Spring Bank believes that its non-cancelable obligations under these agreements are not material and Spring Bank cannot reasonably estimate the timing of if and when they will occur. Spring Bank could also enter into additional research, manufacturing, supplier and other agreements in the future, which may require up-front payments and even long-term commitments of cash.
Off-Balance Sheet Arrangements
Spring Bank did not have during the periods presented, and it does not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
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Recently Issued Accounting Pronouncements
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework Changes to the Disclosure Requirement for Fair Value Measurement. This ASU removes, modifies and adds certain disclosure requirements of ASC Topic 820. The ASU is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 31, 2019. Spring Bank adopted this standard as of January 1, 2020; however, the adoption of this standard did not impact its consolidated financial statements.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on its consolidated financial statements upon adoption.
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
THE MARKET RISK OF SPRING BANK
Spring Bank is exposed to market risk related to changes in interest rates. Its cash, cash equivalents and marketable securities of $23.5 million as of June 30, 2020, consisted of cash, cash equivalents and marketable securities. Spring Banks primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because a significant amount of the marketable securities in its investment portfolio are short-term in nature, an immediate 10% change in market interest rates would not be expected to have a material impact on the fair market value of Spring Banks investment portfolio or on its financial condition or results of operations.
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F-STAR MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of F-stars financial condition and results of operations should be read in conjunction with Selected Historical Financial Data and its financial statements included elsewhere in this proxy statement/prospectus. The historical financial statements of F-star as of and for the year ended December 31, 2018 and 2017 have been restated. See Note 4.9 to the audited financial statements of F-star. Following a management review of the presentation of the statement of (loss)/income for the current reporting period, it was determined that a by function presentation would provide more reliable and relevant information to the users of the F-star and F-star Beta financial statements. See Note 2.1 to audited financial statements of F-star and Note 2.1 to the audited financial statement of F-star Beta. The financial statements of F-star and F-star Beta are presented in pounds sterling and the financial statements of F-star GmbH are presented in euro and in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board (IASB). While F-star intends to adopt U.S. GAAP, its actual historic results under IFRS as issued by the IASB may not be comparable to actual results under U.S. GAAP.
The statements in this discussion regarding industry outlook, F-stars expectations regarding its future performance, liquidity and capital resources and other non-historical statements are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the risks and uncertainties described starting on page 30 in this proxy statement/prospectus. F-stars actual results may differ materially from those contained in or implied by any forward-looking statements. Such factors may be amplified by the ongoing COVID-19 pandemic and its potential impact on F-stars business and the global economy.
Overview
F-star Therapeutics Limited (F-star) was incorporated on August 22, 2018. F-star is a holding company and the principal activities of its subsidiaries are the discovery and development of antibody products to improve the treatment of serious diseases, with a focus on bispecific antibodies for immuno-oncology.
F-star is a clinical-stage immuno-oncology company focused on transforming the lives of patients with cancer through the development of F-stars innovative tetravalent mAb2 bispecific antibodies. With four distinct binding sites in a natural human antibody format, F-star believes its proprietary technology will overcome many of the challenges facing current immuno-oncology therapies, because of the strong pharmacology enabled by tetravalent bispecific binding. F-stars vision is to transform the treatment of cancer through the development of clinically differentiated and well-tolerated mAb2 bispecific antibodies, which are designed to address multiple immune evasion pathways that limit the effect of current immuno-oncology therapies.
F-stars most advanced product candidate, FS118, is currently being evaluated in a Phase 1 clinical trial in heavily pre-treated patients with advanced cancer, having received a median of six lines of such treatments, and who have failed PD-1/PD-L1 therapy. FS118 is a tetravalent mAb2 bispecific antibody targeting two receptors, PD-L1 and LAG-3, both of which are established pivotal targets in immuno-oncology. Preliminary data from 43 patients in this trial showed that administration of FS118 was well-tolerated. In addition, a disease control rate, defined as either a complete response, partial response or stable disease, of 54% was observed in 20 of 37 evaluable patients, and long-term (greater than six months) disease control was observed in six of these patients. F-star expects to report additional results from this Phase 1 trial in the fourth quarter of 2020 and to initiate a proof of concept trial in PD-1 resistant head and neck cancer patients in the first half of 2021.
On January 27, 2020, the U.S. Food and Drug Administration (FDA), accepted the Investigational New Drug (IND) application of product candidate FS120. FS120 is a first-in-class dual agonist bispecific antibody that has the potential to overcome cancer resistance by simultaneously targeting CD137 (4-1BB) and OX40, two receptors present on the surface of tumor-infiltrating lymphocytes. Unlike checkpoint inhibitors, the mechanism of action of FS120 is designed to trigger a positive signal that enhances multiple mechanisms essential for killing tumor cells. FS120 has a natural antibody format. It is engineered to abrogate Fc gamma receptor binding, providing increased specificity and, F-star believes, superior performance while reducing toxicity through
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conditional, crosslink-dependent activation upon binding to both CD137 and OX40. F-star expects to enroll up to 70 patients in a Phase 1 dose escalation clinical trial to assess the safety, tolerability and efficacy of FS120 in patients with advanced malignancies and include those patients who have high co-expression of CD137 and OX40.
F-star also plans to submit a Clinical Trial Application or CTA, to the European Medicines Agency, EMA, for FS222 in the second half of 2020 and to initiate a Phase 1 clinical trial in patients with advanced cancers in the first quarter of 2021. FS222 has the potential to provide clinical benefit through multiple mechanisms based on its tetravalency. These include: (1) blocking the PD-1/PD-L1 immunosuppressive pathway and (2) conditionally clustering and crosslinking CD137 receptors, resulting in activation of CD137 in a PD-L1-dependent manner. F-star believes this dual mechanism of action could amplify the anti-tumor activity of FS222. F-stars preclinical data shows that FS222 has the potential to be more effective than a combination of traditional PD-L1 and CD137 antibodies. FS222 has been designed with specific mutations to make its activity independent of binding to Fc gamma receptors. PD-L1 is frequently highly expressed on cells within cancer tissue compared to non-cancer tissue. Therefore, F-star believes this will make FS222 immune activation conditional within cancer tissue, limit potential systemic toxicities and lead to safety benefits.
F-star expects to incur significant expenses for the foreseeable future as it advances its product candidates through preclinical and clinical development, seeks regulatory approval and pursues commercialization of any approved product candidates. In addition, if F-star obtains marketing approval for any of its product candidates, F-star expects to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Furthermore, following the Share Exchange Agreement closing and listing on the Nasdaq, F-star expects to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that it did not incur as a private company.
As a result, F-star will need substantial additional funding to support its continuing operations and pursue its growth strategy. Until such time as F-star can generate significant revenue from product sales, if ever, F-star expects to finance its operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. F-star may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If F-star fails to raise capital or enter into such agreements as, and when, needed, F-star may have to significantly delay, scale back or discontinue the development and commercialization of one or more of its drug candidates.
As of June 30, 2020, and December 31, 2019, F-star had consolidated cash of £2.2 million and £3.7 million, respectively. As of August 28, 2020, the date of approval of the consolidated financial statements for the period ended June 30, 2020 and the year ended December 31, 2019, and not taking into account any proceeds raised in the Pre-Closing Financing (as defined elsewhere in this proxy statement/prospectus), F-star does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about F-stars ability to continue as a going concern. See Note 2 to F-stars consolidated financial statements and Note 1 in the interim financial statement for the period ended June 30, 2020, appearing elsewhere in this proxy statement/prospectus for additional information on its assessment.
F-star has based its estimate on assumptions that may prove to be wrong, and F-star could deplete its available capital resources sooner than it expects. See Liquidity and Capital Resources.
Accounting Treatment of the Corporate Reorganization under IFRS
On May 7, 2019, F-star completed a corporate reorganization pursuant to which F-star became the direct holding company of each of F-star Delta Ltd (F-star Delta), F-star Beta Ltd (F-star Beta), F-star Biotechnologische Forschungs-und Entwicklungsges, m.b.H. (F-star GmbH) and F-star Alpha Ltd (F-star Alpha) and the indirect holding company of each of F-star Biotechnology Limited (Biotech), and F-star Therapeutics LLC (F-star LLC) (collectively, the F-star Group Entities). F-star GmbH and F-star Beta met the definition of a business in accordance with IFRS 3 Business Combinations (IFRS 3 (revised)). However, for accounting purposes, and due to lack of common control amongst the F-star Group Entities, the
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reorganization has been accounted for as F-star Delta obtaining a controlling interest in F-star GmbH, and F-star Beta, as a business combination in accordance with IFRS 3 paragraph B5 and as F-star Delta acquiring a controlling interest in F-star Alpha through an asset acquisition.
F-star, the legal acquirer of the F-star Group Entities, a company incorporated in the United Kingdom on August 22, 2018, is an entity with no historical operations and was created solely for the purpose of effecting the Corporate Reorganization. For accounting purposes, F-star is not deemed substantive and not deemed the accounting acquirer of the F-star Group Entities. Therefore, historical financial statements of F-star reflect the results of operations and historical financial position and financial performance of F-star Delta, the accounting acquirer.
Entities Included in the F-star Consolidated Financial Statements
Six Months Ended June 30, |
Years Ended December 31, |
|||||||||
Entities |
2020 |
2019 |
2019 |
2018 | 2017 | |||||
F-star Delta |
Full 6
months |
Full 6 months | Full year |
Full
Year |
Full
Year |
|||||
F-star |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | | |||||
F-star GmbH |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | | |||||
F-star Beta |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | | |||||
F-star Alpha |
Full 6
months |
May 7, 2019 to June 30, 2019 | May 7, 2019 to December 31, 2019 | | |
The financial results of F-star Alpha, F-star Beta and F-star GmbH are consolidated from and as a result of the reorganization on May 7, 2019, with F-star Delta as the accounting acquirer.
F-star Beta and F-star GmbH are deemed to be predecessor entities (the Predecessor Group or together with F-star, the Entities). F-star Alpha was determined not to be part of the Predecessor Group as this entity does not represent a significant portion of the Registrants primary business model and operation activities going forward.
The historical financial data for the years ended December 31, 2018 and 2017 have been restated for F-star (formerly F-star Delta, the accounting acquirer). During managements assessment of the impact of fair value adjustments of acquired intangibles on deferred taxation at December 31, 2019, it was noted that temporary timing differences that arise on the application of reinvestment relief on F-star Deltas own intangibles had not been recorded in the financial statements for the years ended December 31, 2018 and 2017. See Note 4.9 of the F-star audited consolidated financial statements for the year ended December 31, 2019. Additionally, see Note 2 for new standards, amendments and interpretations adopted by F-star.
The functional currency of F-star Delta and F-star Beta is pound sterling. While the functional currency of F-star GmbH is euro, the functional currency of F-star GmbHs wholly owned subsidiary in the United Kingdom, F-star Biotechnology Limited, is pound sterling and the functional currency of F-star GmbHs wholly owned subsidiary in the United States of America, F-star Therapeutics LLC, is U.S. dollar. For financial reporting purposes, the financial statements of GmbHs wholly owned subsidiaries which are prepared using the functional currency, have been translated into euros. Assets and liabilities are translated at the exchange rates at the statement of financial position date, revenue and expenses are translated at average exchange rates and equity is translated based on historical exchange rates. Translation adjustments are not included in determining net loss but are included in currency translation differences within foreign exchange reserves, a component of equity.
Foreign currency transactions in currencies different from the functional currency are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange differences resulting from the settlement of such transactions are recorded in the consolidated statements of comprehensive income.
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The financial results of F-star Alpha, F-star Beta and F-star GmbH are consolidated from and as a result of the reorganization on May 7, 2019, with F-star Delta as the accounting acquirer.
For a description of each of F-star Delta (the accounting acquirer in F-stars corporate reorganization), F-star GmbH and F-star Beta see below:
F-star Delta (the accounting acquirer in F-stars corporate reorganization)
F-star Delta is a private limited company, limited by shares, incorporated on December 30, 2016 in the United Kingdom. F-star Deltas principal activities are the discovery and development of antibody products to improve the treatment of serious diseases. F-star Deltas revenues are generated through its collaborative arrangements with one external customer. F-star Delta does not have any products approved for sale and has not generated any revenue from product sales. F-star Delta has funded its operations to date primarily with payments received from its collaboration partner Merck. F-stars net loss was £34.9 million for the year ended December 31, 2019 and profit of £13.3 million and £3.5 million for the years ended December 31, 2018 and 2017, respectively.
F-star GmbH
F-stars GmbH is a private limited company incorporated in Austria as Gesellschaft mit beschränkter Haftung on July 12, 2006. The principal activity of F-star GmbH is research and development within the biotechnology sector, especially the discovery of bispecific antibody products to improve the treatment of serious diseases. This business includes the granting and purchase of licenses and the sale of products and technologies within the biotechnology sector. F-star GmbH does not have any products approved for sale and has not generated any revenue from product sales. F-star GmbH has funded its operations to date primarily with payments received from its collaboration partners, which in certain cases are also related parties, and sales of F-stars equity securities. Although F-star GmbH had a net profit of 1.4 million and 1.5 million for the period ended May 6, 2019 and the year ended December 31, 2018, respectively, since inception it has incurred primarily operating losses and had an accumulated deficit of 32.5 million as at May 6, 2019. As of August 28, 2020, the date of approval of the consolidated financial statements for the period ended December 31, 2019, and not taking into account any proceeds raised in the Pre-Closing Financing, F-star GmbH does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about F-star GmbHs ability to continue as a going concern.
F-star Beta
F-star Beta is a private limited company, limited by shares, incorporated in the United Kingdom on October 14, 2014. F-star Betas principal activities are the discovery and development of antibody products to improve the treatment of serious diseases with a focus on bi-specific antibodies for immuno-oncology. F-star Betas revenues are generated through its collaborative arrangements with one external customer up until September 2019 and provision of intellectual and R&D services to one related party, F-star Delta. F-star Beta does not have any products approved for sale and has not generated any revenue from product sales. F-star Beta has funded its operations to date primarily with payments received from its collaboration partners which in certain cases are also related parties. Its net profit was £0.5 million and £0.5 million for the period ended May 6, 2019 and the year ended December 31, 2018, respectively. As of May 6, 2019, F-star Betas accumulated deficit was £8.0 million. As of August 28, 2020, the date of approval of the financial statements for the period ended December 31, 2019, and not taking into account any proceeds raised in the Pre-Closing Financing. F-star Beta does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about F-star Betas ability to continue as a going concern.
Recent Events
On March 11, 2020, the World Health Organization declared the novel strain of coronavirus (COVID-19) a global pandemic and recommended containment and mitigation measures worldwide. Management took the
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decision in April 2020 to furlough a significant proportion of the research and development (R&D) workforce and took advantage of the UK Government Coronavirus Job Retention Scheme (CJRS) scheme that provided funding to businesses with furloughed staff. The grant funding available in the period ended June 30, 2020 covered 80% of the wages of furloughed employees plus employer National Insurance and pension contributions up to a maximum of £2,500 per month per furloughed employee. All of the government grant income relates to claims under the CJRS scheme in the six month period ended June 30 and has been classified as Other Income. The COVID-19 pandemic has also delayed the development of F-stars preclinical assets and the commencement of its planned clinical trials by several months.
The development of F-stars product candidates and clinical trials could be disrupted and materially, adversely affected in the future by a pandemic, epidemic or outbreak of an infectious disease like the recent outbreak of COVID-19. For example, as a result of measures imposed by the governments in regions affected by COVID-19 businesses and schools have been suspended due to quarantines or stay at home orders intended to contain this outbreak. COVID-19 continues to spread globally and has spread to over 150 countries, including the United States, United Kingdom and Austria. While the COVID-19 outbreak continues to evolve, international stock markets continue to reflect the uncertainty associated with the slow-down in the world economies and the reduced levels of international travel experienced since the beginning of January 2020. As of the date of this proxy statement/prospectus the COVID-19 pandemic has had an impact upon F-stars operations, and management continues to monitor and assess the ongoing impact on F-star. F-star is still assessing its business plans and the impact COVID-19 may have on its ability to advance the development of its product candidates or to raise financing to support the development of its product candidates, but no assurances can be given that this analysis will enable F-star to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or in F-stars sector in particular. The spread of an infectious disease, including COVID-19, may also result in the inability of F-stars suppliers to deliver components or raw materials on a timely basis or materially and adversely affect F-stars collaborators and potential strategic partners ability to perform preclinical studies and clinical trials. See Risk FactorsA pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect F-stars business and financial results and could cause a disruption to the development of its product candidates.
Material Weaknesses in Internal Controls over Financial Reporting
F-star management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with IFRS as issued by IASB. Although F-star is not yet subject to the certification or attestation requirements of Section 404 of the Sarbanes-Oxley Act, in connection with the preparation and audit of its financial statements for the year ended December 31, 2019, it management identified two material weaknesses related to its financial reporting process. As a result, the financial statements for the years ended December 31, 2017 and 2018 required restatements related to income taxes.
These material weaknesses relate to (i) the lack of formal policies and procedures and sufficient complement of personnel to implement effective segregation of duties and (ii) the company did not have sufficient formality and evidence of controls over key reports and spreadsheets.
F-star has commenced measures to remediate these material weaknesses and it intends to hire additional finance and accounting personnel with appropriate expertise to perform specific functions and allow for proper segregation of duties, design key controls and implement improved processes and internal controls, build its financial management and reporting infrastructure, and further develop and document its accounting policies and financial reporting procedures, including ongoing senior management review and audit committee oversight.
Components of F-star and F-star Beta Results of Operations
Revenue
To date, none of the F-star Group Entities have generated any revenue from the sales of their product candidates. The Entities revenues have been solely derived from collaboration and license agreements with
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several customers. The terms of these arrangements contain multiple revenue streams associated with: (i) up-front payments, (ii) research and development services and (iii) option fees to acquire a group legal entity as in the case of F-star Gamma Limited, which was sold to Denali. Customers are also obligated to pay certain milestone fees, which are generally non-refundable and are payable upon satisfactory completion of specified research and development activities.
To the extent F-star enters into any license arrangements or strategic alliances, F-star expects that any revenue it generates will fluctuate from quarter-to-quarter as a result of the transfer of control regarding fulfilment of performance obligations such as pre-clinical, clinical, regulatory and commercialization achievements. If F-star fails to develop product candidates in a timely manner, obtain regulatory approval for them, or commercialize them, F-stars ability to generate future revenues, and its results of operations and financial position would be adversely affected.
Costs Related to Collaborative Arrangements
Costs related to collaborative arrangements include all costs incurred which are directly attributable to the R&D activities which generate revenue under F-stars license and collaboration agreements. Where revenue includes the license of perpetual, exclusive intellectual property rights, an appropriate amount of the asset is charged to costs related to collaborative agreements, based on an allocation of cost or value of the rights that have been licensed. Cost related to collaborative agreements also include FTE costs and external R&D costs (for subcontracted research and development activities), that have directly derived revenue, and amortization of capitalized intellectual property rights that have been acquired for the purpose of fulfilling the groups obligations under its license and collaboration agreements.
Research and Development Costs
R&D costs consist primarily of costs incurred in connection with the clinical costs of product candidates, except those costs incurred in directly generating revenue under F-stars license and collaboration agreements, employee costs, and employee share-based payment expense. Expenditure on research activities are recognized in the consolidated statement of comprehensive income as incurred. Development expenditure is capitalized only if the expenditure can be measured reliably, the product is technically and commercially feasible, future economic benefits are probable, and the group has sufficient resources to complete or sell the asset. Those expenses associated with R&D and clinical costs primarily include:
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expenses incurred under agreements with contract research organizations (CROs) as well as investigative sites and consultants that conduct F-stars clinical trials, preclinical studies and other scientific development services; |
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manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials; |
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expenses incurred for outsourced professional scientific development services; |
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costs for laboratory materials and supplies used to support F-stars research activities; |
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allocated facilities costs, depreciation and other expenses, which include rent and utilities; and |
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up-front, milestone and management fees for maintaining licenses under F-stars third-party licensing agreements. |
F-star recognizes external R&D costs based on an evaluation of the progress to completion of specific tasks using information provided to it by its internal program managers and service providers.
Employees have employment contracts with F-star GmbH, and compensation expenses are recharged to F-star Beta on a Full Time Equivalent (FTE) basis. F-star Beta recharges FTE to F-star Delta as appropriate.
Certain outsourced vendor expenses are charged from F-star GmbH to F-star Delta. FTE expenses are charged by F-star GmbH to F-star Beta, and some of these expenses are further charged from F-star Beta to F-star Delta. The fully loaded FTE charge used in 2017, 2018 and 2019 was £225,000, £230,000 and £235,000 per annum per employee, respectively, to cover employee expense, infrastructure and consumables. The total amounts of R&D
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expenses recharged from F-star GmbH to F-star Beta were £7.5 million, £7.1 million and £2.4 million for the periods ended December 31, 2017, December 31, 2018 and May 6, 2019, respectively. Up until May 7, 2019 board fees were accumulated in F-star GmbH and were recharged to F-star Alpha, F-star Beta and F-star Delta. Internal resources are used primarily to oversee and conduct research and development as well as for managing preclinical development, process development, manufacturing and clinical development activities.
Research and development activities are central to the Entities business models. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, F-star expects that research and development expenses will increase over the next several years as F-star increases personnel costs, initiate and conduct additional clinical trials and prepare regulatory filings related to the various product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and administrative functions. General and administrative expenses also include facility-related costs, patent filing and prosecution costs, insurance and marketing costs and professional fees for legal, consulting, accounting, audit and tax services. Other expense also includes FTE charges to F-star Beta and F-star Delta, and foreign currency transaction losses. F-star expects that general and administrative expenses will increase in the future as F-star expands its operating activities.
If F-star completes the Transaction, F-star would become a SEC registrant and would expect to incur significant additional costs associated with being a SEC registrant. These increases will likely include legal fees, costs associated with Sarbanes-Oxley compliance, accounting fees, and directors and officers liability insurance premiums.
Other Income
Other operating income is primarily rent received from subletting an office in the U.S. and interest received on overdue trade receivable balances.
Other Gains
Other gains are foreign exchange gains due to the fluctuation of GBP, U.S. dollar and the Euro.
Fair Value Losses on Financial Liabilities at Fair Value Through Profit or Loss (FVTPL)
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) is the fair value adjustment of the convertible notes as measured using level 3 inputs.
Finance Income
Finance income is bank interest received.
Finance Costs
Finance costs are primarily bank interest payable and similar charges, the interest liability on leased assets and convertible debt notes, and foreign exchange losses incurred.
Income Tax Benefit/ (Charge)
In the years ended December 31, 2019, 2018 and 2017 and the six-month periods ended June 30, 2020 and 2019 the F-star Group Entities were subject to corporate taxation in the United Kingdom and Austria.
The UK-established entities have generated losses and some profits in the United Kingdom since inception and have therefore not paid significant United Kingdom corporation tax. F-star GmbH has historical losses in Austria with more recent profits, which has resulted in payment of Austrian corporation tax in the years ended December 31, 2019, 2018 and 2017. The corporation tax benefit/ (tax) presented in F-stars statements of
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comprehensive income/(loss) represents the tax impact from its operating activities in the United Kingdom and Austria, which has generated taxable income in certain periods. As the Entities located in the United Kingdom carry out extensive research and development activities, they seek to benefit from the United Kingdom research and development tax credit cash rebate regime: The Small and Medium-sized Enterprises R&D Tax Credit Program (SME Program). Qualifying expenditures largely comprise employment costs for research staff, consumables expenses incurred under agreements with third parties that conduct research and development, preclinical activities, clinical activities and manufacturing on F-stars behalf and certain internal overhead costs incurred as part of research projects. No research and development activities are carried out in Austria and so F-star is not able to utilize the research and development premium available under the Austrian corporation tax regime.
The Small and Medium-sized Enterprises research and development tax credit received in the United Kingdom permits companies to deduct an extra 130% of their qualifying costs from their yearly profit or loss, as well as the normal 100% deduction, to make a total 230% deduction. If the company is loss making it is entitled to claim a tax credit worth up to 14.5% of the surrenderable loss. To qualify for SME research & development relief companies are required to employ fewer than 500 staff and have a turnover of under 100.0 million or a balance sheet total of less than 86.0 million.
Income tax charge increased by £1.9 million to a tax charge of £2.6 million for the year ended December 31, 2018 from £0.7 million tax charge for the year ended December 31, 2017. This increase is due to a £2.0 million increase in the deferred tax charge in the year ended December 31, 2018, due to an increase in the deferred tax liability that resulted from a temporary difference arising on the application of reinvestment relief on intangible assets. Reinvestment relief relates to the corporate intangible assets regime and is available where proceeds from the realization of intangible assets are reinvested in similar assets. This allows an entity to defer the taxable credit arising on the realization of intangible assets.
In the event F-star generates revenues in the future, F-star may benefit from the United Kingdom patent box regime that allows profits attributable to revenues from patents or patented products to be taxed at an effective rate of 10%.
Value Added Tax (VAT) is broadly charged on all taxable supplies of goods and services by VAT-registered businesses. In the United Kingdom, under current rates, an amount of 20% of the value, as determined for VAT purposes, of the goods or services supplied is added to all sales invoices and is payable to the UKs tax authority, HMRC. Similarly, VAT paid on purchase invoices is generally reclaimable from HMRC. In Austria, under current rates, an amount of 20% of the value, as determined for VAT purposes, of the goods or services supplied is added to all sales invoices and is payable to the Austrian tax authority. Similarly, VAT paid on purchase invoices is generally reclaimable from the Austrian tax authority.
Components of F-star GmbHs Results of Operations
Revenues
F-star GmbHs revenues are generated through its collaborative arrangement with one external collaborator, Denali, and provision of intellectual property licenses and R&D services to one related party, F-star Beta. The terms of the arrangement with the external collaborator include performing R&D services and the grant of intellectual property rights. In exchange for the initial grant of intellectual property rights and R&D services, the group has received non-refundable upfront license payments and is eligible to receive variable consideration in the form of milestone payments that are based on the achievement of defined collaboration objectives.
UK revenue was generated from intellectual property licenses granted (which includes milestone income as well as licensing income) and provision of R&D services on a fully loaded full-time equivalent (FTE) basis.
Revenue generated in the United States related to the receipt of a percentage of the proceeds due on sale of a related party entity, Denali BBB Holding Limited (formerly F-star Gamma Limited) and the option to nominate targets for drug development under intellectual property license agreements.
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Other Income
Other income consists primarily of interest earned on loans between F-star Alpha and F-star GmbH, and state aid grant relating to the CJRS scheme.
Raw Materials and Consumables Used
Raw materials and consumables used consists primarily of costs for laboratory materials and supplies used to support F-stars research activities.
Depreciation, Amortization, and Loss on Disposal
Depreciation, amortization, and loss on disposal consists primarily of depreciation and amortization expense from tangible fixed assets and patents, as well as losses on disposal of tangible fixed assets.
Employee Expenses
Employee expenses primarily consists of salaries, employment taxes and pension contributions.
Other Expenses
Other expenses are primarily R&D costs and the profit or loss on exchange differences.
Finance Income
Finance income is primarily interest income received from a related party.
Finance Costs
Finance costs is primarily interest expense related to borrowings from a related party, and lease interest.
Income Tax Credit/ (Charge)
The income tax credit/ (charge) is the expected tax charge for the period based on the GbmH groups tax rate for the periods 2019, 2018 and 2017 of 25% and the reported tax charge for the period.
Results of Operations
Comparison of the Six-Month Periods Ended June 30, 2020 and 2019
F-star Therapeutics Limited (F-star)
The following summarizes the results of F-stars operations for the Six Month Periods Ended June 30, 2020 and 2019.
For accounting purposes, F-star is not deemed substantive and not deemed the accounting acquirer of the F-star Group Entities. Therefore, historical results of operations of F-star reflect the results of operations of F-star Delta, the accounting acquirer, for periods before May 7, 2019.
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UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS
Six Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Statements of Comprehensive Loss |
||||||||||||
Revenue |
£ | 1,537 | £ | 20,154 | (£18,616 | ) | ||||||
Costs related to collaborative arrangements |
(333 | ) | (17,437 | ) | 17,104 | |||||||
Research and development costs |
(7,423 | ) | (9,575 | ) | 2,152 | |||||||
General and administrative expenses |
(4,960 | ) | (3,764 | ) | (1,196 | ) | ||||||
Other income |
371 | | 371 | |||||||||
Other expenses |
(1,282 | ) | (243 | ) | (1,040 | ) | ||||||
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Loss from operations |
(12,090 | ) | (10,865 | ) | (1,225 | ) | ||||||
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) |
(1,509 | ) | | (1,509 | ) | |||||||
Finance income |
8 | 1 | 7 | |||||||||
Finance costs |
(438 | ) | | (438 | ) | |||||||
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|
|
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Loss before tax from continuing operations |
(14,028 | ) | (10,864 | ) | (3,164 | ) | ||||||
Income tax credit |
2,692 | 756 | 1,936 | |||||||||
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|||||||
Loss for the year attributable to equity holders of the parent |
(£11,336 | ) | (£10,108 | ) | (£1,228 | ) | ||||||
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Revenue
Six Month Periods Ended
June 30, |
Change | |||||||||||
2020 | 2019 | |||||||||||
(in thousands) | ||||||||||||
Revenue by entity |
||||||||||||
F-star (formerly F-star Delta) |
£ | 950 | £ | 18,874 | (£17,924 | ) | ||||||
F-star GmbH |
587 | 1,279 | (692 | ) | ||||||||
F-star Beta |
| | | |||||||||
F-star Alpha |
| | | |||||||||
|
|
|
|
|
|
|||||||
Total Revenue |
£ | 1,537 | £ | 20,153 | (£18,616 | ) | ||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to June 30, 2019.
Revenue was £1.5 million during the first six-month period of 2020, as compared to £20.1 million during the six-month period ended June 30, 2019, a decrease of £18.6 million.
Revenue of £1.5 million for the six-month period ended June 30, 2020, consists entirely of external licensing revenue and R&D funding (recognized as a single performance obligation) from two customers, Denali (£0.6 million) and Merck (0.9 million). External collaboration agreements with Denali and Merck are described in Note 4.4 and Note 5 of the F-star consolidated financial statements for the year ended December 31, 2019.
On an entity and customer basis revenue from Merck decreased £17.9 million to £0.9 million for the six month period ended June 30, 2020 from £18.9 million for the six month period ended June 30, 2019. This revenue is recognized in F-star. Revenue from Denali decreased £0.7 million to £0.6 million for the six month period ended June 30, 2020 from £1.3 million for the six month period ended June 30, 2019. This revenue is recognized in F-star GmbH.
Revenue of £20.1 million recognized in the six-month period ended June 30, 2019 was generated from the same two customers (Merck and Denali), with £10.2 million related to external licensing revenue and R&D funding (recognized as a single performance obligation) from the 2017 License and Collaboration agreement
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(2017 LCA) with Merck, and £8.6 million from the License and Collaboration Agreement that was executed on May 14, 2019 (2019 LCA), which replaced the 2017 LCA. Revenue of £1.3 million was recognized under the LCA with Denali, which related to external licensing revenue and R&D funding (recognized as a single performance obligation) for the second Fcab (Fcab#2) included in the collaboration.
The £18.6 million decrease between the first six-month period of 2019 versus the first six-month period of 2020 mainly related to the impact of the enactment of the 2019 LCA. The 2019 LCA converted the existing purchase option over the entire share capital of F-star Delta to an intellectual property licensing arrangement. A £8.6 million option fee was recognized in June 2019 at a point in time, which did not recur in the six-month period ended June 30, 2020. Following the enactment of the 2019 LCA the R&D funding was related to one molecule as opposed to R&D funding and recognition of the upfront licensing fee for five molecules in the previous agreement, which accounts for a decrease in revenue of £9.3 million between the two periods. The remaining £0.7 million decrease between the two periods relates to the Denali collaboration, as set out below.
£1.2 million was paid by Denali in the first six-month period of 2019 on achievement of a development milestone that related to the first molecule in the collaboration (Fcab#1). This was recognized at a point in time, as all other performance obligations in relation to that molecule had been satisfied by that date and did not recur in the first six months of 2020. This was offset by an increase in external licensing revenue and R&D funding (recognized as a single performance obligation) of £0.5 million relating to the second Fcab included in the collaboration (Fcab#2). This was due to the acquisition of F-star GmbH (which holds the contract with Denali) by the group on May 7, 2019, which resulted in a full period of revenue in the six-months ended June 30, 2020 but a partial period of revenue in the six months ended June 30, 2019.
Cost Related to Collaborative Arrangements
Six Month Period
Ended June 30, |
Change | |||||||||||
2020 | 2019 | |||||||||||
(in thousands) | ||||||||||||
Costs related to collaborative arrangements |
||||||||||||
Derecognition of intangible assets on licensing of IP rights |
£ | | (£12,574 | ) | £ | 12,574 | ||||||
FTE expense |
(120 | ) | (1,929 | ) | 1,809 | |||||||
External R&D expense |
(44 | ) | (2,458 | ) | 2,414 | |||||||
Amortization of intangible assets |
(169 | ) | (476 | ) | 307 | |||||||
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Total costs related to collaborative arrangements |
(£333 | ) | (£17,437 | ) | £17,104 | |||||||
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|
|
|
|||||||
Six Month Period
Ended June 30, |
Change | |||||||||||
2020 | 2019 | |||||||||||
(in thousands) | ||||||||||||
Costs related to collaborative arrangements |
||||||||||||
F-star (formerly F-star Delta) |
(£274 | ) | (£17,401 | ) | £17,127 | |||||||
F-star GmbH |
(59 | ) | (36 | ) | (23 | ) | ||||||
F-star Beta |
| | | |||||||||
F-star Alpha |
| | | |||||||||
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|
|
|
|
|
|||||||
Total costs related to collaborative arrangements |
(£333 | ) | (£17,437 | ) | £17,104 | |||||||
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|
|
|
|
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The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to June 30, 2019.
Predominantly all of the costs related to collaborative arrangements were incurred by F-star, formerly F-star Delta, in the six month periods ended June 30, 2020 and 2019, of £0.3 million and £17.4 million, respectively.
Costs related to collaborative arrangements decreased by £17.1 million to £0.3 million for the six month period ended June 30, 2020 from £17.4 million for the six month period ended June 30, 2019. The decrease was
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primarily due to a £12.6 million derecognition of intangible assets due to the licensing of perpetual, exclusive intellectual property to Merck in the six month period ended June 30, 2019 and no intangible asset derecognition in the six month period ended June 30, 2020. FTE expense was £1.8 million lower, and external R&D expense was £2.4 million lower for the six month period ended June 30, 2020 due to five molecules being developed in partnership under the 2017 LCA with Merck until May 14, 2019 and from that point onwards under the 2019 LCA, only one molecule being developed, resulting in significantly lower FTE effort and external R&D expense being incurred. Amortization of intangible assets was £0.3 million lower due to a number of intangible asset impairments, as there were no management plans to further develop specific product candidates in the second half of 2019.
The table below summarizes F-stars costs related to collaborative arrangements by program:
Six Month Period
Ended June 30, |
Change | |||||||||||
2020 | 2019 | |||||||||||
(in thousands) | ||||||||||||
Direct costs related to collaborative arrangements by program |
||||||||||||
FS118 |
£ | | (£2,958 | ) | £ | 2,958 | ||||||
FS122 |
| (13,397 | ) | 13,397 | ||||||||
FS422 |
(274 | ) | (104 | ) | (170 | ) | ||||||
DN02 |
(59 | ) | (36 | ) | (23 | ) | ||||||
Other |
| (942 | ) | 942 | ||||||||
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|
|
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|
|
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Total costs related to collaborative arrangement by program |
(£333 | ) | (£17,437 | ) | £17,104 | |||||||
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|
|
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For program costs since inception see R&D costs below.
Research and Development Costs
Six Month Ended
June 30, |
Change | |||||||||||
2020 | 2019 | |||||||||||
(in thousands) | ||||||||||||
Research and development |
||||||||||||
F-star (formerly F-star Delta) |
(£1,219 | ) | (£2,946 | ) | £1,727 | |||||||
F-star GmbH |
(4,305 | ) | (2,353 | ) | (1,952 | ) | ||||||
F-star Beta |
(1,902 | ) | (4,275 | ) | 2,373 | |||||||
F-star Alpha |
3 | (1 | ) | 4 | ||||||||
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|
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|
|
|
|||||||
Total Research and development costs |
(£7,423 | ) | (£9,575 | ) | £2,152 | |||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to June 30, 2019.
R&D costs decreased by £2.2 million to £7.4 million during the first six months of 2020, from £9.6 million during the six months ended June 30, 2019.
The £1.7 million lower R&D costs in F-star, formerly F-star Delta, relates primarily to a £1.8 million R&D impairment charge in 2019. The £1.9 million higher R&D costs in F-star GmbH is primarily due to £1.2 million higher salaries and related employment expenses in 2020. The £2.4 million lower R&D costs in F-star Beta are primarily due to £1.3 million higher toxicology costs and £1.3 million higher manufacturing costs in 2019.
This decrease of £2.2 million was primarily due to a decrease in toxicology costs of £1.4 million and a decrease in manufacturing expense of £0.9 million due to drug safety studies and batch manufacturing for FS222 and FS120 being substantially completed in 2019. There was also a £1.8 million R&D impairment charge in 2019 that related to the discontinuation of one project on the termination of the 2017 LCA that did not recur in 2020. The FS118 Phase 1 clinical study had only 2 patients remaining at the start of 2020 which resulted in
285
clinical trial CRO and associated assay costs decreased by £1.8 million. Other R&D expense decreases of £0.8 million in aggregate are due to COVID-19 restrictions in 2020 (Furlough) and a general decrease in preclinical activities as FS120 and FS222 move towards clinical phase.
In addition to the decreases in expense explained above, in the six-month period ended June 30, 2019 the financial data relates to F-star Delta only and there were significant fully-loaded FTE charges billed from F-star GmbH via F-star Beta in that period of £1.7 million which eliminate on consolidation from May 7, 2019 onwards, when F-star Delta, F-star GmbH and F-star Beta became part of the same group (see Note 1 of the F-star consolidated financial statements for the year ended December 31, 2019). However, this elimination of billed FTE costs from F-star Beta has been offset by the acquisition of F-star GmbH into the group as at May 7, 2019 as F-star GmbH employs the workforce that is billed to F-star Beta and F-star Delta, and so the full cost of the R&D-related workforce (£2.3 million) has been brought into the F-star R&D expense total from May 7, 2019 onwards.
The table below summarizes F-stars research and development costs by program:
Six Month Period Ended
June 30, |
Change | |||||||||||
2020 | 2019 | |||||||||||
(in thousands) | ||||||||||||
£ | £ | £ | ||||||||||
Direct research and development costs by program |
||||||||||||
FS118 |
(£2,045 | ) | (£1,113 | ) | (£932 | ) | ||||||
FS120 |
(1,547 | ) | (2,239 | ) | 692 | |||||||
FS222 |
(1,912 | ) | (2,393 | ) | 481 | |||||||
Other |
(1,918 | ) | (3,830 | ) | 1,912 | |||||||
|
|
|
|
|
|
|||||||
Total research and development costs by program |
(£7,423 | ) | (£9,575 | ) | £ | 2,152 | ||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to June 30, 2019.
F-star begins to separately track program expenses at candidate nomination, at which point F-star accumulates all costs to support that program to date. Through June 30, 2020, since candidate nomination of FS118, FS120 and FS222, F-star has incurred approximately £32.9 million, £14.3 million, and £13.2 million, respectively, of expenses for the development of these programs.
General and Administrative Expenses
Six Month Periods Ended
June 30, |
Change | |||||||||||
2020 | 2019 | |||||||||||
(in thousands) | ||||||||||||
General and administrative by entity |
||||||||||||
F-star (formerly F-star Delta) |
(£895 | ) | (£721 | ) | (£174 | ) | ||||||
F-star GmbH |
(3,991 | ) | (2,873 | ) | (1,118 | ) | ||||||
F-star Beta |
(71 | ) | (152 | ) | 81 | |||||||
F-star Alpha |
(3 | ) | (18 | ) | 15 | |||||||
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|
|
|
|
|
|||||||
Total general and administrative |
(£4,960 | ) | (£3,764 | ) | (£1,196 | ) | ||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to June 30, 2019.
General and administrative expenses were £4.9 million for the six-month period ended June 30, 2020 as compared to £3.8 million for the six-month period ended June 30, 2019. The increase of £1.2 million was primarily due to the acquisition of F-star GmbH at May 7, 2019 which has historically incurred a significant proportion of G&A costs and recharged them to F-star Beta and F-star Delta as part of a fully loaded FTE rate (see research and development expense section above). Therefore, for most G&A expenditure, in the six-month
286
period ended June 30, 2020 expenditure is for the F-star Group Entities for the full six months, whereas in the same period in 2019 expenditure is of F-star Delta only to May 6, 2019, and all the F-star Group Entities from May 6 to June 30, 2019.
Due to the impact of the above, G&A-related staff costs have increased by £1.4 million, and other G&A costs increased by £0.9 million which mainly include rent and property service charges, board costs and depreciation charges for G&A-related property, plant and equipment and audit and accountancy costs.
The G&A staff expense increases stated above were offset by a number of decreases. Legal costs decreased by £0.7 million due to the renegotiation of the Merck LCA in the six month period ended June 30, 2019 and the legal costs related to the corporate reorganization on May 7, 2019. Consultancy costs, patent fees and recruitment costs decreased by £0.5 million in aggregate, due to one-off activities in the six month period ended June 30, 2019, including external consultancy to provide advice on the corporate reorganization on May 7, 2019, national patent filings for a number of assets and the recruitment of the current chief financial officer and chief medical officer.
On an entity basis the £1.1 million increase in F-star GmbH is primarily due to salaries due to the formation of the F-star consolidated group.
Other Income
Other income of £0.4 million in the six month period ended June 30, 2020, relates to government grants received under the Coronavirus Job Retention Scheme (CJRS) for the costs of furloughed staff. This income is not expected to continue past September 15, 2020.
Other Expenses
Other expenses were £1.3 million during the first six month period of 2020, as compared to £0.2 million during the six month period ended June 30, 2019. The £1.1 million difference is due to higher unrealized foreign exchange differences in the six month period ended June 30, 2020.
Fair Value Losses on Financial Liabilities at Fair Value through Profit or Loss (FVTPL)
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) increased by £1.5 million due to the fair value adjustment in the six month period ended June 30, 2020 relating to the convertible notes issued by F-star.
Finance Income
Finance income increased £7 thousand to £8 thousand for the six month period ended June 30, 2020, from £1 thousand for the six month period ended June 30, 2019. Finance income primarily relates to bank interest income received. This income fluctuates depending on cash balances deposited at the bank and the decreasing rates of interest paid on cash deposits.
Finance Costs
The finance costs increase of £0.4 million relates primarily to interest payable on the convertible notes issued by F-star, which were not in issue in the first half of 2019.
Income Tax Credit
Income tax credit was £2.7 million during the first six month period ended June 30, 2020, as compared to £0.8 million during the six month period ended June 30, 2019. The increase in the income tax benefit is due primarily to United Kingdom research and development tax credits receivable from the UK tax authority, HMRC.
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Comparison of the Years Ended December 31, 2019 and 2018
F-star Therapeutics Limited (F-star)
The following summarizes the results of F-stars operations for the Years Ended December 31, 2019 and 2018.
For accounting purposes, F-star is not deemed substantive and not deemed the accounting acquirer of the F-star Group Entities. Therefore, historical results of operations of F-star reflects the results of operations of F-star Delta, the accounting acquirer, for the periods before May 7, 2019. The historical 2018 comparatives are for F-star Delta only.
Year Ended
December 31, |
||||||||||||
2019 | 2018 | Change | ||||||||||
(in thousands) | ||||||||||||
Statements of Comprehensive (Loss)/ Income |
||||||||||||
Revenue |
£ | 21,882 | £ | 29,997 | (£8,115 | ) | ||||||
Costs related to collaborative arrangements |
(17,960 | ) | (13,892 | ) | (4,068 | ) | ||||||
Research and development costs |
(32,673 | ) | | (32,673 | ) | |||||||
General and administrative expenses |
(12,295 | ) | (399 | ) | 11,896 | |||||||
Other income |
113 | | 113 | |||||||||
Other gains |
310 | 195 | 115 | |||||||||
|
|
|
|
|
|
|||||||
(Loss)/ profit from operations |
(40,622 | ) | 15,900 | (56,522 | ) | |||||||
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) |
(1,106 | ) | | (1,106 | ) | |||||||
Finance income |
8 | 4 | 4 | |||||||||
Finance costs |
(256 | ) | | (256 | ) | |||||||
|
|
|
|
|
|
|||||||
(Loss)/ profit before tax from continuing operations |
(41,976 | ) | 15,905 | (57,881 | ) | |||||||
Income tax credit/ (charge) |
7,016 | (2,636 | ) | 9,652 | ||||||||
|
|
|
|
|
|
|||||||
Net (loss)/ profit attributable to equity holders of the parent |
(£34,959 | ) | £ | 13,269 | (£48,228 | ) | ||||||
|
|
|
|
|
|
Revenue
Years Ended
December 31, |
Change | |||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Revenue by entity |
||||||||||||
F-star (formerly F-star Delta) |
£ | 20,000 | £ | 29,997 | (£9,997 | ) | ||||||
F-star GmbH |
1,882 | | 1,882 | |||||||||
F-star Beta |
| | | |||||||||
F-star Alpha |
| | | |||||||||
|
|
|
|
|
|
|||||||
Total Revenue |
£ | 21,882 | £ | 29,997 | (£8,115 | ) | ||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to December 31, 2019. 2018 amount relates to Delta only.
Revenue decreased £8.1 million to £21.9 million for the year ended December 31, 2019, from £30.0 million for the year ended December 31, 2018. The revenue of F-star Delta decreased by £10.0 million and was offset by an increase in revenues from F-star GmbH of £1.9 million. On an entity and customer basis revenue from Merck decreased £10.0 million to £20.0 million for the year ended December 31, 2019 from £30.0 million for the year ended December 31, 2018. This revenue is recognized in F-star. Revenue from Denali increased £1.9 million to £1.9 million for the year ended December 31, 2019 (2018: £Nil). This revenue is recognized in F-star GmbH.
288
Since inception external customer revenue has been generated from only two external customers (Merck and Denali).
Revenue of £21.9 million was recognized for the year ended December 31, 2019, of which £10.3 million related to external licensing revenue and R&D funding (recognized as a single performance obligation) from the 2017 License and Collaboration agreement (2017 LCA) with Merck and £1.1 million from the License and Collaboration Agreement that was enacted on May 14, 2019 (2019 LCA). Following the enactment of the 2019 LCA the R&D funding was related to one molecule as opposed to R&D funding and recognition of the upfront licensing fee for five molecules in the previous agreement. On enactment of the 2019 LCA a £8.6 million option fee was recognized at a point in time in June 2019 which did not occur in the year ended December 31, 2018.
The remaining increase of £1.9 million relates to £1.2 million that was paid by Denali during the year ended December 31, 2019 on achievement of a development milestone that related to the first molecule in the collaboration (Fcab#1). This was recognized at a point in time, as all other performance obligations in relation to that molecule had been satisfied by that date and did not occur in 2018. The remaining £0.7 million increase relates to external licensing revenue and R&D funding (recognized as a single performance obligation) for the second Fcab included in the collaboration (Fcab #2). This was due to the acquisition of F-star GmbH (which holds the contract with Denali) by the group on May 7, 2019, which resulted in revenue included in the group in the year ended December 31, 2019 but none in the year ended December 31, 2018.
Costs Related to Collaborative Arrangements
Year Ended December 31, | Change | |||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Costs related to collaborative arrangements |
||||||||||||
Derecognition of intangible assets on licensing of IP rights |
(£12,574 | ) | £ | | (£12,574 | ) | ||||||
FTE expense |
(2,275 | ) | (4,824 | ) | 2,549 | |||||||
External R&D expense |
(2,490 | ) | (7,985 | ) | 5,495 | |||||||
Amortization of intangible assets |
(621 | ) | (1,084 | ) | 463 | |||||||
|
|
|
|
|
|
|||||||
Total costs related to collaborative arrangements |
(£17,960 | ) | (£13,892 | ) | (£4,068 | ) | ||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to December 31, 2019. 2018 amount relates to F-star Delta only.
£3.9 million increase is recognized in F-star, formerly F-star Delta. The remaining £0.2 million was recognized in F-star GmbH. The increase is primarily due to the 2019 Merck agreement.
Year Ended December 31, | Change | |||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Costs related to collaborative arrangements |
||||||||||||
F-star (formerly F-star Delta) |
(£17,780 | ) | (£13,892 | ) | (£3,888 | ) | ||||||
F-star GmbH |
(180 | ) | | (180 | ) | |||||||
F-star Beta |
| | | |||||||||
F-star Alpha |
| | | |||||||||
|
|
|
|
|
|
|||||||
Total costs related to collaborative arrangements |
(£17,960 | ) | (£13,892 | ) | (£4,068 | ) | ||||||
|
|
|
|
|
|
289
The table below summarizes F-stars costs related to collaborative arrangements by program:
Year Ended
December 31, |
Change | |||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Direct costs related to collaborative arrangements by program |
||||||||||||
FS118 |
(£2,958 | ) | (£9,519 | ) | £6,561 | |||||||
FS122 |
(13,397 | ) | | (13,397 | ) | |||||||
FS422 |
(483 | ) | | (483 | ) | |||||||
DN02 |
(180 | ) | | (180 | ) | |||||||
Other |
(942 | ) | (4,373 | ) | 3,431 | |||||||
|
|
|
|
|
|
|||||||
Total costs related to collaborative arrangement by program |
(£17,960 | ) | (£13,892 | ) | (£4,068 | ) | ||||||
|
|
|
|
|
|
The costs relating to collaborative arrangements increased by £4.1 million to £18.0 million for the year ended December 31, 2019 from £13.9 million for the year ended December 31, 2018. The increased expense primarily related to £12.6 million from the derecognition of an intangible asset on exclusive licensing of IP rights (product candidate FS122) in 2019, offset by £5.5 million lower external R&D expense relating to the Merck 2017 agreement and £3.0 million lower FTE expense relating to the Merck 2017 agreement, and £0.7 million lower amortization of intangible assets. The decrease in FTE and R&D expense is due to five molecules being developed in partnership under the 2017 LCA with Merck until May 14, 2019 and from that point onwards under the 2019 LCA, only one molecule was being developed, resulting in significantly lower FTE effort and external R&D expense being incurred. Amortization of intangible assets decreased due to a number of intangible asset impairments that occurred in the second half of 2019.
Research and Development Costs
Year Ended
December 31, |
Change | |||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Research and development |
||||||||||||
F-star (formerly F-star Delta) |
(£14,113 | ) | £ | | (£14,113 | ) | ||||||
F-star GmbH |
(6,283 | ) | | (6,283 | ) | |||||||
F-star Beta |
(12,256 | ) | | (12,256 | ) | |||||||
F-star Alpha |
(21 | ) | | (21 | ) | |||||||
|
|
|
|
|
|
|||||||
Total Research and development costs |
(£32,673 | ) | £ | | (£32,673 | ) | ||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to December 31, 2019. 2018 amount relates to F-star Delta only.
The table below summarizes F-stars research and development costs by program:
Year Ended
December 31, |
Change | |||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Direct research and development costs by program |
||||||||||||
FS118 |
(£7,047 | ) | £ | | (£7,047 | ) | ||||||
FS120 |
(6,873 | ) | | (6,873 | ) | |||||||
FS222 |
(5,632 | ) | | (5,632 | ) | |||||||
Others |
(13,121 | ) | | (13,121 | ) | |||||||
|
|
|
|
|
|
|||||||
Total research and development costs by program |
(£32,673 | ) | £ | | (£32,673 | ) | ||||||
|
|
|
|
|
|
290
There is no comparative R&D expenditure as all costs in F-star (formerly Delta Limited, the accounting acquirer) were incurred in relation to the Merck 2017 LCA and therefore all costs were included within costs related to collaborative arrangements for 2018 and this continued up to the execution of the Merck 2019 LCA. Since the Merck 2019 LCA was enacted, only costs incurred in related to FS422 and the partnered neuroscience assets are presented within costs related to collaborative arrangements, with all other expenditure (including FS118) now recognised in R&D. These activities have been supplemented by the R&D costs of all the other F-star Group Entities being consolidated from May 7, 2019, particularly in relation to FS120 and FS122.
The R&D costs of £32.7 million include some significant increases due to the addition of F-star Beta costs since the corporate reorganization that relate to FS120 and FS222. These include manufacturing costs of £7.7 million, which relates to the batch manufacturing runs, clinical assay development and clinical trial set up costs of £1.1 million, toxicology study costs of £1.8 million and other R&D outsourced costs of £1.6 million.
The move to multi-patient cohorts for FS118 Phase 1 trials in 2019, resulted in increased CRO and associated clinical assay costs of £3.4 million. In addition £2.3 million of batch manufacturing costs and £0.7 million of other R&D outsourced costs were incurred in relation to FS118.
There were three intangible asset impairments during the year ended December 31, 2019, which resulted in a charge of £6.6 million compared with nil in the year ended December 31, 2018. These impairments related to FS231 that was no longer being developed after the termination of the Merck 2017 LCA, FS131 which management decided to discontinue development for in September 2019 and FS21 a molecule that was developed with an F-star partner, and was terminated in September 2019. As a result of these impairments goodwill was also deemed to be impaired by management and so an additional £0.3 million expense was also recorded. Amortization of £1.1 million was also recorded in relation to R&D-related intangible assets, whereas all amortisation was included in costs related to collaborative arrangements in the prior year.
In addition to the increases in expenses explained above, the acquisition of F-star GmbH into the group at May 7, 2019 also resulted in significant cost increases from the prior period. As F-star GmbH employs the workforce that supplies R&D labor to F-star Beta and F-star Delta, the full cost of this workforce was recorded by the group from May 7, 2019 onwards, resulting in an increase from the prior year of £3.9 million. The acquisition of F-star GmbH also resulted in an increase of £1.1 million in laboratory consumables, £0.8 million in R&D-related infrastructure costs and £0.3 million for depreciation of R&D-related fixed assets.
F-star begins to separately track program expenses at candidate nomination, at which point F-star accumulates all costs to support that program to date. Through December 31, 2019, since candidate nomination of FS118, FS120 and FS222 F-star has incurred approximately £30.9 million, £12.8 million and £11.3 million, respectively, of expenses for the development of these programs.
General and Administrative
Year Ended
December 31, |
Change | |||||||||||
2019 | 2018 | £ | ||||||||||
(in thousands) | ||||||||||||
General and administrative by entity |
||||||||||||
F-star (formerly F-star Delta) |
(£3,657 | ) | (£399 | ) | (£3,258 | ) | ||||||
F-star GmbH |
(8,373 | ) | | (8,373 | ) | |||||||
F-star Beta |
(251 | ) | | (251 | ) | |||||||
F-star Alpha |
(14 | ) | | (14 | ) | |||||||
|
|
|
|
|
|
|||||||
Total general and administrative expense |
(£12,295 | ) | (£399 | ) | (£11,896 | ) | ||||||
|
|
|
|
|
|
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to December 31, 2019. 2018 amount relates to F-star Delta only.
Included in the financial results of F-star Delta for the year ended December 31, 2018 were board costs of £0.1 million recharged from F-star GmbH. The remaining £0.3 million relates to external vendors for legal and patent fees.
291
General and administrative (G&A) expenses were £12.3 million for the year ended December 31, 2019 as compared to £0.4 million for the year ended December 31, 2018. The increase of £11.9 million was primarily due to the acquisition of F-star GmbH at May 7, 2019 which has historically incurred a significant proportion of G&A costs and recharged them to F-star Beta and F-star Delta as part of a fully loaded FTE rate (see research and development cost section above). Therefore, for most G&A expenditure, in the year ended December 31, 2019 costs were included from May 6, 2019 onwards, whereas they are not included in the group financial statements for 2018.
Due to the impact of the above, G&A-related staff costs have increased by £5.4 million, legal costs have increased by £1.5 million and consultancy by £2.1 million due to expenditure during 2019 on advice for the negotiation of the 2019 LCA and corporate reorganization, infrastructure costs have increased by £0.9 million and audit and accountancy by £0.7 million. Other G&A costs increased by £1.3 million which mainly include patent fees (which is dependent upon filing dates), board costs and subscriptions.
Other Income
Other income was £0.1 million primarily due to rental income from office space sublet to an unrelated third party in the U.S.A. received in the year ended December 31, 2019 (2018: £nil). This income is not expected to continue as the lease U.S. office lease has now terminated.
Other Gains
Other gains increased £0.1 million to £0.3 million for the year ended December 31, 2019 from £0.2 million for the year ended December 31, 2018. This gain is foreign exchange gains.
Fair Value Adjustments through the Income Statement
The £1.1 million in the year ended December 31, 2019, relates to the fair value adjustment of convertible notes issued by F-star.
Finance Income
Finance income increased £4 thousand to £8 thousand in the year ended December 31, 2019, from £4 thousand for the year ended December 31, 2018. The increase was due to higher foreign exchange gains in the year ended December 31, 2018.
Finance Costs
The finance costs of £0.3 million in the year ended December 31, 2019, relate primarily to interest payable on the convertible notes issued by F-star of £0.2 million and £0.1 million foreign exchange loss.
Income Tax Credit/ (Charge)
Income tax credit/ (charge) was £7.0 million during the year ended December 31, 2019, as compared to £2.6 million of corporation tax charge during the year ended December 31, 2018. The income tax benefit is primarily due to United Kingdom research and development tax credits receivable from the UK tax authority HMRC. F-star Delta was ineligible to make a research and development tax claim for the year ended December 31, 2018, as the research and development was externally funded.
Comparison of the Years Ended December 31, 2018 and 2017
F-star (Formerly F-star Delta)
For accounting purposes, F-star is not deemed substantive and not deemed the accounting acquirer of the F-star Group Entities. Therefore, historical results of operations of F-star reflect the results of operations of F-star Delta, the accounting acquirer, for the years ended December 31, 2018 and 2017.
292
The following summarizes the results of F-stars operations for the years ended December 31, 2018 and 2017.
Year Ended
December 31, |
Change | |||||||||||
2018 | 2017 | |||||||||||
(in thousands) | ||||||||||||
Statements of Comprehensive (Loss)/ Income |
||||||||||||
Revenue |
£ | 29,997 | £ | 11,027 | £ | 18,970 | ||||||
Costs related to collaborative arrangements |
(13,893 | ) | (6,346 | ) | (7,547 | ) | ||||||
Research and development costs |
| | | |||||||||
General and administrative expenses |
(399 | ) | (616 | ) | 217 | |||||||
Other gains |
195 | 71 | 124 | |||||||||
|
|
|
|
|
|
|||||||
Profit from operations |
15,900 | 4,136 | 11,764 | |||||||||
Finance income |
4 | | 4 | |||||||||
|
|
|
|
|
|
|||||||
Profit before tax from continuing operations |
15,905 | 4,136 | 11,769 | |||||||||
Income tax charge |
(2,636 | ) | (657 | ) | (1,979 | ) | ||||||
|
|
|
|
|
|
|||||||
Profit attributable to equity holders of the parent | £13,269 | £3,479 | £9,790 | |||||||||
|
|
|
|
|
|
Revenue
Revenue increased by £19.0 million to £30.0 million for the year ended December 31, 2018 from £11.0 million for the year ended December 31, 2017. This increase of £19.0 million relates to revenue for achieving a development milestone and for the release of deferred revenue from the up-front fee from Merck of £13.0 million as performance obligations were satisfied by F-star, and a £6.0 million increase in R&D FTE invoiced to Merck.
For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable, so any revenue trend from milestone payments is less predictable.
Costs Related to Collaborative Arrangements
Costs related to collaborative arrangements increased by £7.5 million to £13.9 million in the year ended December 31, 2018 from £6.3 million for the year ended December 31, 2017. This was primarily due to the Merck 2017 LCA being signed on June 4, 2017. No costs were incurred for the period January 1, 2017 and June 3, 2017.
F-star begins to separately track program expenses at candidate nomination, at which point F-star accumulates all costs to support that program to date. Through December 31, 2018, since candidate nomination of FS118, F-star has incurred approximately £12.9 million of expenses for the development of this program.
There were no R&D costs for the years ended December 31, 2018 and 2017, as these costs were all attributed to costs related to collaborative arrangements.
General and Administrative Expense
G&A costs decreased by £0.2 million to £0.4 million in the year ended December 31, 2018 from £0.6 million for the year ended December 31, 2017. This decrease was primarily due to higher legal fees regarding the Merck 2017 contract negotiation.
Other Gains
Other gains increased to £0.2 million for the year ended December 31, 2018 from £0.1 million for the year ended December 31, 2017. The 2017 gain of £0.1 million relates to a gain on foreign exchange differences.
Finance Income
Finance income increased to £4 thousand for the year ended December 31, 2018 (2017: £Nil). This finance income relates to bank interest received.
293
Income Tax Charge
Income tax charge increased by £1.9 million to a tax charge of £2.6 million for the year ended December 31, 2018 from £0.7 million tax charge for the year ended December 31, 2017. This increase is due to a £2.0 million increase in the deferred tax charge in the year ended December 31, 2018, due to an increase in the deferred tax liability that resulted from a temporary difference arising on the application of reinvestment relief on intangible assets. Reinvestment relief relates to the corporate intangible assets regime and is available where proceeds from the realization of intangible assets are reinvested in similar assets. This allows an entity to defer the taxable credit arising on the realization of intangible assets.
Comparison of the Period Ended May 6, 2019 and Year Ended December 31, 2018 and the Years Ended December 31, 2018 and 2017
Forschungs- und Entwicklungsges.m.b.H. (F-star GmbH) Only
The following summarizes the results of F-star GmbHs operations for the period ended May 6, 2019, and the year ended December 31, 2018.
Period Ended
May 6, |
Year Ended
December 31, |
Change | ||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Statements of Comprehensive Income |
||||||||||||
Revenue |
| 9,057 | | 21,088 | (12,031 | ) | ||||||
Other income |
591 | 505 | 86 | |||||||||
Raw materials and consumables used |
(1,339 | ) | (3,960 | ) | 2,621 | |||||||
Depreciation, amortization and loss on disposal |
(454 | ) | (835 | ) | 381 | |||||||
Employee expenses |
(3,369 | ) | (7,995 | ) | 4,626 | |||||||
Other expenses |
(3,087 | ) | (7,429 | ) | 4,342 | |||||||
|
|
|
|
|
|
|||||||
Operating profit |
1,399 | 1,374 | 25 | |||||||||
Finance income |
125 | 164 | (39 | ) | ||||||||
Finance costs |
(109 | ) | (223 | ) | 114 | |||||||
|
|
|
|
|
|
|||||||
Profit before tax on ordinary activities |
1,415 | 1,315 | 100 | |||||||||
Tax (charge)/ benefit on profit on ordinary activities |
(49 | ) | 195 | (244 | ) | |||||||
|
|
|
|
|
|
|||||||
Profit attributable to owners of the parent |
| 1,366 | | 1,510 | ( 144 | ) | ||||||
|
|
|
|
|
|
Revenue
Revenue decreased 12.1 million to 9.0 million for the period ended May 6, 2019, from 21.1 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year of revenue.
Revenue was 9.0 million for the period ended May 6, 2019. The revenue is made up of licensing revenue from F-star Beta of 0.8 million, licensing and services revenue from an external customer of 1.6 million and increased services to related entities with regards to R&D services on a fully loaded FTE basis of 6.6 million.
Revenue was 21.1 million for the year ended December 31, 2018. UK revenue of 16.0 million was generated from intellectual property licenses granted, which includes milestone income as well as up-front licensing income, and provision of R&D services on a fully loaded FTE basis. Revenue of 5.1 million was generated in the United States related to the receipt of a percentage of the proceeds due on the sale of a former related party, F-star Gamma Limited (re-named Denali BBB Holding Limited) and an option to nominate targets for drug development under an intellectual license.
In May 2018, Denali Therapeutics Inc. exercised its option to acquire F-star Gamma Limited.
294
For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable, so any revenue trend from milestone payments is less predictable.
Other Income
Other income increased 0.1 million to 0.6 million for the period ended May 6, 2019, from 0.5 million for the year ended December 31, 2018. The increase is due to higher exchange rate differences in the period ended May 6, 2019.
Other income was 0.6 million for the period ended May 6, 2019. 0.1 million relates to board of director fees recharged to related entities, and 0.5 million relates to unrealized foreign exchange gains.
Other income was 0.5 million for the year ended December 31, 2018 and related to board of director fees recharged to related entities. Up until the reorganization on May 7, 2019, the board costs were accumulated in F-star GmbH and recharged to the other F-star Group Entities.
Raw Materials and Consumables Used
Raw materials and consumables decreased 2.6 million to 1.4 million for the period ended May 6, 2019, from 4.0 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year consumption of raw materials and consumables. This expense relates to materials and consumables consumed by research and development activity supporting early stage discovery projects. In 2019, key product candidates FS118 and FS120 moved from development into clinical trials.
Depreciation, Amortization and Loss on Disposal
Depreciation and amortization decreased 0.3 million to 0.5 million for the period ended May 6, 2019, from 0.8 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year of depreciation and amortization expense.
On January 1, 2019 F-star GmbH adopted IFRS 16 and 1.0 million of right to use assets were added to the statement of financial position. These generated 0.2 million of depreciation for the period ended May 6, 2019.
Employee Expenses
Employee expenses consisting of salaries, benefits, pension expense and share-based compensation expense decreased by 4.6 million to 3.4 million for the period ended May 6, 2019, from 8.0 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year of employee expenses.
Other Expenses
Other expenses consisting of professional fees, research & development expense, information technology and infrastructure expense decreased by 4.3 million to 3.1 million for the period ended May 6, 2019, from 7.4 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year of other expenses. Professional fees were £0.8 million for the period ended May 6, 2019 due to the reorganization of the Entities as compared to £1.1 million for the year ended December 31, 2018.
F-star GmbHs research and development expense consists of platform technology development through to program inception and/or collaboration. There was no inception to date program spend in F-star GmbH as the program costs are in F-star Beta and F-star Delta.
Finance Income
Finance income decreased 0.1 million to 0.1 million for the period ended May 6, 2019, from 0.2 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year of finance income. Finance income relates to interest income due to a loan receivable from F-star Beta.
295
Finance Costs
Finance costs decreased 0.1 million to 0.1 million for the period ended May 6, 2019, from 0.2 million for the year ended December 31, 2018. This is due to a partial period being compared to a full year of finance costs.
Finance costs were 0.1 million for the period ended May 6, 2019 and was due to interest expense related to borrowings from a related party F-star Alpha.
Finance costs were 0.2 million for the year ended December 31, 2018 and was due to interest expense related to borrowings from a related party F-star Alpha.
Income Tax (Charge)/ Credit
A provision for corporation tax payable of 49 thousand has been estimated for the period ended May 6, 2019 based on an Austrian corporation tax charge of 25% of taxable profits, off-set by an additional tax deduction for UK R&D expenditure. The December 31, 2018 tax benefit of 0.2 million is based on an Austrian corporation tax charge of 25% of taxable profits, off-set primarily by R&D tax credits, and an additional tax deduction for UK R&D expenditure.
The following summarizes the results of F-star GmbHs operations for the years ended December 31, 2018 and 2017
Year Ended
December 31, |
||||||||||||
2018 | 2017 | Change | ||||||||||
(in thousands) | ||||||||||||
Statements of Comprehensive Income |
||||||||||||
Revenue |
| 21,088 | | 15,749 | | 5,339 | ||||||
Other income |
505 | 232 | 273 | |||||||||
Raw materials and consumables used |
(3,960 | ) | (2,958 | ) | (1,002 | ) | ||||||
Depreciation, amortization and loss on disposal |
(835 | ) | (559 | ) | (276 | ) | ||||||
Employee expenses |
(7,995 | ) | (6,853 | ) | (1,141 | ) | ||||||
Other expenses |
(7,429 | ) | (5,613 | ) | (1,816 | ) | ||||||
|
|
|
|
|
|
|||||||
Operating profit/ (loss) |
1,375 | (3 | ) | 1,378 | ||||||||
Finance income |
164 | 116 | 48 | |||||||||
Finance costs |
(223 | ) | (201 | ) | (22 | ) | ||||||
|
|
|
|
|
|
|||||||
Profit/ (loss) before tax on ordinary activities |
1,315 | (88 | ) | 1,403 | ||||||||
Income tax credit |
195 | 225 | (30 | ) | ||||||||
|
|
|
|
|
|
|||||||
Profit attributable to owners of the parent | 1,510 | 137 | 1,373 | |||||||||
|
|
|
|
|
|
Revenue
Revenue increased 5.3 million to 21.1 million for the year ended December 31, 2018, from 15.7 million for the year ended December 31, 2017. All revenue in the years ended December 2018 and 2017 was generated from intellectual property licenses granted, both milestone income and licensing income, and the provision of R&D services on a fully loaded basis. In August 2016, F-star GmbH entered into a licensing and collaboration agreement (the Denali License and Collaboration Agreement).
Revenue was 21.1 million for the year ended December 31, 2018. UK revenue of 16.0 million was generated from intellectual property licenses granted, which includes milestone income as well as up-front licensing income, and provision of R&D services on a fully loaded FTE basis.
Revenue of 5.1 million was generated in the United States related to the receipt of a percentage of the proceeds due on the sale of a former related party, F-star Gamma Limited (re-named Denali BBB Holding Limited) and an option to nominate targets for drug development under intellectual property license agreements.
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In May 2018, Denali Therapeutics Inc. exercised its option to acquire F-star Gamma Limited.
Revenue was 15.7 million for the year ended December 31, 2017. The revenue of 15.7 million was all generated in the UK from intellectual property licenses granted, which includes milestone income as well as up-front licensing income, and provision of R&D services on a fully loaded FTE basis.
For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable, so any revenue trend from milestone payments is less predictable.
Other Income
Other income increased 0.3 million to 0.5 million for the year ended December 31, 2018, from 0.2 million for the year ended December 31, 2017. The increase is due to higher exchange rate differences in the period ended December 31, 2018.
Raw Materials and Consumables Used
Raw materials and consumables increased 1.0 million to 4.0 million for the year ended December 31, 2018, from 3.0 million for the year ended December 31, 2017. This expense relates to materials and consumables consumed by research and development activity supporting early stage discovery projects. The increase was due to the increased activity achieved by an increased number of staff.
Depreciation, Amortization and Loss on Disposal
Depreciation and amortization increased 0.2 million to 0.8 million for the year ended December 31, 2018, from 0.6 million for the year ended December 31, 2017. The increased charge was due to the timing of when assets were acquired.
Employee Expenses
Employee expenses consisting of salaries, benefits, pension expense and share-based compensation expense increased by 1.1 million to 8.0 million for the year ended December 31, 2018, from 6.9 million for the year ended December 31, 2017. This is primarily due to an increase in staff from an average of 79 staff in 2017 to an average of 99 staff in 2018.
Other Expenses
Other expenses increased by 1.8 million to 7.4 million for the year ended December 31, 2018, from 5.6 million for the year ended December 31, 2017. Other expenses consisting of professional fees, R&D expense, information technology and infrastructure expense. The primary reason for the increase was due to 1.0 million increase in R&D costs. F-star GmbHs research and development expense consists of platform technology development through to program inception and/or collaboration. There is no inception to date program spend in F-star GmbH as the program costs are in F-star Beta and F-star Delta.
Finance Income
Finance income increased 0.1 to 0.2 million for the year ended December 31, 2018, from 0.1 million for the year ended December 31, 2017. This is primarily due to interest income on a loan receivable from F-star Beta.
Finance Costs
Finance costs were 0.2 million for the years ended December 31, 2018 and 2017. These costs are primarily due to interest expense related to borrowings from a related party F-star Alpha.
Income Tax Credit
The income tax credit of 0.2 million in both the years ended December 31, 2018 and 2017 is based on an Austrian corporation tax charge of 25% of taxable profits, off-set primarily by R&D tax credits, and an additional tax deduction for UK R&D expenditure.
297
F-star Beta Limited (F-star Beta) Only
The following summarizes the results of F-star GmbHs operations for the period ended May 6, 2019, and the year ended December 31, 2018
Period Ended
May 6, |
Year Ended
December 31, |
Change | ||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Statements of Comprehensive Income |
||||||||||||
Revenue |
£ | 7,903 | £ | 17,394 | (£9,491 | ) | ||||||
Costs relating to collaborative arrangements |
(1,864 | ) | (6,719 | ) | 4,856 | |||||||
Research and development costs |
(5,107 | ) | (12,049 | ) | 6,942 | |||||||
General and administrative expenses |
(909 | ) | (345 | ) | (563 | ) | ||||||
Other gains |
| 1 | (1 | ) | ||||||||
Other expenses |
(58 | ) | (20 | ) | (38 | ) | ||||||
|
|
|
|
|
|
|||||||
Loss on operations |
(34 | ) | (1,739 | ) | 1,705 | |||||||
Finance costs |
(103 | ) | (145 | ) | 42 | |||||||
|
|
|
|
|
|
|||||||
Loss before tax from continuing operation |
(137 | ) | (1,883 | ) | 1,747 | |||||||
Corporation tax benefit |
639 | 2,416 | (1,777 | ) | ||||||||
|
|
|
|
|
|
|||||||
Profit for the financial period and comprehensive income attributable to the equity shareholders of the parent |
£ | 502 | £ | 533 | (£31 | ) | ||||||
|
|
|
|
|
|
Revenue
Revenue decreased £9.5 million to £7.9 million for the period ended May 6, 2019, from £17.4 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year of revenue. All revenue in the period ended May 6, 2019, and for the year ended December 31, 2018, was generated from a single customer, which is a related party (F-star Delta) located in the United Kingdom. The revenue is generated through its intellectual property licensing and research and development service arrangements.
Cost relating to Collaborative Arrangements
Costs relating to collaborative arrangements decreased £4.8 million to £1.9 million for the period ended May 6, 2019 from £6.7 million for the year ended December 31, 2018. Costs relating to collaborative arrangements are primarily project costs and pass through costs recharged from F-star GmbH and then recharged by F-star Beta to F-star Delta. The main reasons for the decrease is that there was an intangible derecognition of £1.9 million in the year ended December 31, 2018, and none in the period ended May 6, 2019 and that May 6, 2019 is a partial period so less R&D services were incurred compared to the 12 months ended December 31, 2018.
The table below summarizes F-star Betas costs related to collaborative arrangements by activity:
Period Ended
May 6, |
Year Ended
December 31, |
Change | ||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Direct costs related to collaborative arrangements by program |
||||||||||||
Recharges that relate to revenue from F-star Delta |
(£1,864 | ) | (£4,825 | ) | £ | 2,961 | ||||||
Intangible derecognition |
| (1,895 | ) | 1,895 | ||||||||
|
|
|
|
|
|
|||||||
Total costs related to collaborative arrangement by program |
(£1,864 | ) | (£6,720 | ) | £ | 4,856 | ||||||
|
|
|
|
|
|
298
Research and Development Costs
R&D costs decreased by £6.9 million to £5.1 million for the period ended May 6, 2019, from £12.0 million for the year ended December 31, 2018. This is primarily due to a partial period being compared to a full year of other expenses.
R&D costs are primarily FTE costs spent on early stage product candidates and platform development recharged from F-star GmbH to F-star Beta.
The table below summarizes F-star Betas R&D costs by program:
Period Ended
May 6, |
Year Ended
December 31, |
Change | ||||||||||
2019 | 2018 | |||||||||||
(in thousands) | ||||||||||||
Direct research and development costs by program |
||||||||||||
FS120 |
(£2,425 | ) | (£4,002 | ) | £ | 1,577 | ||||||
FS222 |
(1,727 | ) | (3,304 | ) | 1,577 | |||||||
Others |
(954 | ) | (4,743 | ) | 3,789 | |||||||
|
|
|
|
|
|
|||||||
Total research and development costs by program |
(£5,107 | ) | (£12,049 | ) | £ | 6,942 | ||||||
|
|
|
|
|
|
F-star begins to separately track program expenses at candidate nomination, at which point F-star accumulates all costs to support that program to date. Through May 6, 2019, since candidate nomination of FS118, FS222, and FS120, F-star Beta has incurred approximately £5.9 million, £5.5 million, and £6.7 million of expenses for the development of these programs, respectively. The FS322 program commenced in 2018 and F-star Beta has incurred approximately £0.9 million of program expenses.
General and Administrative Expense
General and administrative expense increased £0.6 million to £0.9 million for the period ended May 6, 2019 from £0.3 million for the year ended December 31, 2018. There was a £0.7 million share-based compensation expense charge in the period ended May 6, 2019, on shares granted to the Chief Executive Officer on March 6, 2019, £0.1 million higher legal fees, £0.1 million of other expense allocated to general and administrative expense, off-set by £0.3 million higher patent fees for the year ended December 31, 2018.
Finance Costs
Finance costs decreased £42 thousand to £103 thousand for the period ended May 6, 2019, from £145 thousand for the year ended December 31, 2018. This is due to a partial period being compared to a full year of finance costs. Finance costs for the period ended May 6, 2019 related to interest expense from a loan from F-star Biotechnology Limited, a wholly owned subsidiary of F-star GmbH.
Corporation Tax Benefit
Income tax benefit of £0.6 million for the period ended May 6, 2019, is due estimated R&D tax credits expected for the period. Income tax benefit of £2.4 million for the year ended December 31, 2018 is due to R&D tax credits of £2.4 million received from the UK tax authority, HMRC.
299
The following summarizes the results of F-star Betas operations for the period years ended December 31, 2018 and 2017.
Year Ended
December 31, |
Change | |||||||||||
2018 | 2017 | |||||||||||
(in thousands) | ||||||||||||
Statements of Comprehensive Income |
||||||||||||
Revenue |
£ | 17,394 | £ | 14,993 | £ | 2,401 | ||||||
Costs relating to collaborative arrangements |
(6,719 | ) | (3,289 | ) | (3,430 | ) | ||||||
Research and development costs |
(12,049 | ) | (11,933 | ) | (115 | ) | ||||||
General and administrative expenses |
(345 | ) | (352 | ) | 7 | |||||||
Other gains |
1 | 166 | (166 | ) | ||||||||
Other expenses |
(20 | ) | | (20 | ) | |||||||
|
|
|
|
|
|
|||||||
Loss on operations |
(1,739 | ) | (415 | ) | (1,324 | ) | ||||||
Finance costs |
(145 | ) | (102 | ) | (43 | ) | ||||||
|
|
|
|
|
|
|||||||
Loss before tax from continuing operation |
(1,883 | ) | (517 | ) | (1,366 | ) | ||||||
Corporation tax benefit |
2,416 | 705 | 1,711 | |||||||||
|
|
|
|
|
|
|||||||
Profit for the year and comprehensive income attributable to the equity holders of the parent |
£ | 533 | £ | 189 | £ | 344 | ||||||
|
|
|
|
|
|
Revenue
Revenue increased £2.4 million to £17.4 million for the year ended December 31, 2017, from £15.0 million for the year ended December 31, 2017.
Revenue for the year ended December 31, 2018 was generated from a single customer, which is a related party (F-star Delta) located in the United Kingdom. The agreement between F-star Delta and Merck was signed in June 2017, so 2018 has a full year of R&D services from F-star Beta to F-star Delta as compared to 2017.
Revenue for the year ended December 31, 2017 £12.2 million was generated from a related party F-star Delta in the UK, and £2.8 million was generated from a partner in the European Union. The revenue is generated through its intellectual property licensing and research and development service arrangements. The performance obligations under the partner agreement were fully satisfied in August 2017.
Cost Relating to Collaborative Arrangements
Costs relating to collaborative arrangements increased £3.4 million to £6.7 million for the year ended December 31, 2018 from £3.3 million for the year ended December 31, 2017. The increase was primarily due to £2.5 million higher direct labor costs, and £0.9 million higher costs associated with the derecognition of intangible assets, being £1.9 million in 2018 and £1.0 million in 2017. Costs relating to collaborative arrangements are primarily project costs and pass through costs recharged from F-star GmbH and then recharged by F-star Beta to F-star Delta.
The table below summarizes F-star Betas costs related to collaborative arrangements by activity:
Year Ended
December 31, |
Change | |||||||||||
2018 | 2017 | |||||||||||
(in thousands) | ||||||||||||
Direct costs related to collaborative arrangements by program |
||||||||||||
Recharges that relate to revenue from F-star Delta |
(£4,824 | ) | (£2,304 | ) | (£2,520 | ) | ||||||
Intangible derecognition |
(1,895 | ) | (985 | ) | (910 | ) | ||||||
|
|
|
|
|
|
|||||||
Total costs related to collaborative arrangement by program |
(£6,719 | ) | (£3,289 | ) | (£3,430 | ) | ||||||
|
|
|
|
|
|
300
Research and Development Costs
R&D costs increased by £0.1 million to £12.0 million for the year ended December 31, 2018, from £11.9 million for the year ended December 31, 2017.
R&D costs primarily of FTE costs spent on early stage product candidates and platform development. FS118 was part of F-star Beta before it was transferred to F-star Delta in 2017. There were significantly higher R&D costs spent on FS120 and FS222 in 2018 as compared to 2017.
The table below summarizes F-star Betas R&D costs by program:
Year Ended December 31, | Change | |||||||||||
2018 | 2017 | |||||||||||
(in thousands) | ||||||||||||
Direct research and development costs by program |
||||||||||||
FS118 |
£ | | (£3,801 | ) | £ | 3,801 | ||||||
FS120 |
(4,002 | ) | (366 | ) | (3,636 | ) | ||||||
FS222 |
(3,304 | ) | (463 | ) | (2,841 | ) | ||||||
Other |
(4,743 | ) | (7,303 | ) | 2,560 | |||||||
|
|
|
|
|
|
|||||||
Total research and development costs by program |
(£12,049 | ) | (£11,933 | ) | (£116 | ) | ||||||
|
|
|
|
|
|
F-star Beta begins to separately track program expenses at candidate nomination, at which point F-star accumulates all costs to support that program to date. Through December 31, 2018, since candidate nomination of FS118, FS222, and FS120, F-star Beta has incurred approximately £5.9 million, £3.8 million, and £4.4 million of expenses for the development of these programs, respectively. The FS322 program commenced in 2018 and F-star Beta has incurred approximately £0.3 million of program expenses.
General and Administrative Expense
General and administrative expense was £0.3 million for the years ended December 31, 2018 and 2017. In 2018, there were £0.2 million higher patent fees, offset by £0.1 million license fees share-based payment compensation expense.
Other Gains
Other gains decreased £0.2 million to £1 thousand for the year ended December 31, 2018 from £0.2 million for the year ended December 3, 2017. The £0.2 million decrease was primarily due to a £0.2 million gain on foreign exchange.
Finance Costs
Finance costs increased £43 thousand to £145 thousand for year ended December 31, 2018, from £102 thousand for the year ended December 31, 2017. This cost relates to interest expense from a loan from F-star Biotechnology Limited, a wholly owned subsidiary of F-star GmbH.
Corporation Tax Benefit
Corporation tax benefit increase of £1.7 million was due primarily to £2.4 million of R&D tax credits received in the year ended May 6, 2019 as compared to £0.7 million for the year ended December 31, 2018.
F-star Liquidity and Capital Resources
Sources of Liquidity
To date, F-star has funded its operations through private placements of equity securities, convertible debt issuance and upfront, milestone revenue and expense reimbursement payments received from its collaborators. F-star has invested all of its financial resources and efforts into developing its product candidates, building its
301
intellectual property portfolio, conducting business planning, licensing its technology to its collaborators, raising capital and providing general and administrative support for these operations. F-star does not currently have any approved products and have never generated any revenue from product sales. The group consists of clinical and pre-clinical stage biopharmaceutical entities focused on the development of novel immunotherapy products. There are no products approved for commercial sale. Therapeutic candidates are based on bispecific antibodies which are new and largely unproven. The groups limited experience in taking molecules through clinical development, particularly considering the rapidly evolving cancer immuno-oncology field, may make it difficult to evaluate current business and predict future performance. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. The inability to address these risks successfully would have a materially adverse effect on the groups business and prospects.
Future Funding Requirements
To date, F-star has not generated any revenue from the sale of commercial products. F-star does not expect to generate any significant revenue from product sales unless and until F-star obtains regulatory approval of and successfully commercializes any of its product candidates and F-star does not know when, or if, this will occur. F-star expects to continue to incur significant losses for the foreseeable future, and F-star expects the losses to increase as it continues the development of, and seeks regulatory approvals for, its product candidates, and begin to commercialize any future approved products. F-star is subject to all of the risks typically related to the development of new product candidates, and F-star may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. Moreover, following the completion of this offering, F-star expects to incur additional costs associated with operating as a public company. F-star anticipates that it will need substantial additional funding in connection with its continuing operations.
Until F-star can generate a sufficient amount of revenue from the commercialization of its product candidates, if ever, it expects to finance its incremental cash needs through a combination of equity offerings, debt financings, working capital lines of credit, potential licenses and collaboration agreements. Additional working capital may not be available on commercially reasonable terms, if at all. If F-star is unable to raise additional capital in sufficient amounts or on terms acceptable to F-star, it may have to significantly delay, reduce or discontinue the development or commercialization of one or more of its product candidates. If F-star raises additional funds through the issuance of additional debt or equity securities, it could result in dilution to its existing shareholders increased fixed payment obligations and the existence of securities with rights that may be senior to those of its ordinary shares If F-star incurs indebtedness, F-star could become subject to covenants that would restrict its operations and potentially impair its competitiveness, such as limitations on its ability to incur additional debt, limitations on its ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact F-stars ability to conduct its business. Additionally, any future collaborations F-star enters into with third parties may provide capital in the near term but limit F-stars potential cash flow and revenue in the future. Any of the foregoing could have a material adverse effect on F-stars business, financial condition and results of operations.
Since its inception, F-star has incurred significant losses. F-star has an accumulated deficit of £26.8 million through June 30, 2020 and an accumulated deficit of £16.9 million for the year ended December 31, 2019. F-star expects to incur substantial additional losses in the future as it conducts and expands its research and development activities.
F-star may seek to fund its operations through public equity or private equity or debt financings, as well as other sources. However, F-star may be unable to raise additional working capital, or if it is able to raise additional working capital, it may be unable to do so on commercially favorable terms. F-stars failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on its business, results of operations and financial condition and its ability to continue to develop its product candidates.
302
Concurrently with the execution of the Exchange Agreement on July 29, 2020, certain existing investors of F-star, pursuant to binding equity commitment letters by and between each investor and F-star, agreed to subscribe for ordinary shares of F-star in a private placement as of immediately prior to the Closing (the Pre-Closing Financing). In addition, F-star plans to seek equity financing from new investors as part of the Pre-Closing Financing. As of , 2020, F-star had received commitments from investors to purchase $ million of ordinary shares of F-star in the Pre-Closing Financing, and F-star may continue to seek additional commitments in the Pre-Closing Financing until 11:59 p.m., Eastern time on the 10th day prior to the Special Meeting. The closing of the Exchange would provide access to the existing cash deposits of Spring Bank as well as expected additional equity financing to be raised by F-star in the Pre-Closing Financing.
As of June 30, 2020, and December 31, 2019, F-star had consolidated cash of £2.2 million and £3.7 million, respectively. As of August 28, 2020, the date of approval of the consolidated financial statements for the period ended June 30, 2020 and the year ended December 31, 2019 and not taking into account any proceeds raised in the Pre-Closing Financing, F-star does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about F-stars ability to continue as a going concern.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
Liquidity and Capital Resources
Cash Flows
The following tables summarize the Entities cash flows for each of the periods presented:
F-star Therapeutics Limited (F-star)
Cash Flow for the Six Month Periods Ended June 30, 2020 and 2019
Six Month Period
June 30, |
||||||||
2020 | 2019 | |||||||
(thousands) | ||||||||
Net cash used in operating activities |
(£1,728 | ) | (£3,683 | ) | ||||
Net cash generated from investing activities |
8 | 4,095 | ||||||
Net cash generated from/ (used in) financing activities |
174 | (89 | ) | |||||
Cash and cash equivalents |
£ | 2,155 | £ | 6,773 |
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to June 30, 2019.
Cash Flow for the Years Ended December 31, 2019, 2018 and 2017
Year Ended
December 31, |
||||||||||||
2019 | 2018 | 2017 | ||||||||||
(thousands) | ||||||||||||
Net cash (used in)/ generated from operating activities |
(£16,557 | ) | £ | 12,298 | £ | 13,627 | ||||||
Net cash generated from/ (used in) investing activities |
4,105 | (9,620 | ) | (9,847 | ) | |||||||
Net cash generated from financing activities |
9,733 | | | |||||||||
Cash and cash equivalents |
£ | 3,736 | £ | 6,458 | £ | 3,780 |
The 2019 amount relates to F-star Delta only to May 6, 2019, then all F-star Group Entities from May 7, 2019 to December 31, 2019. 2018 and 2017 amounts relate to F-star Delta only.
303
Cash Flow for the Period Ended May 6, 2019 and the years ended December 31, 2018 and 2017
F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H. (F-star GmbH)
The following summarizes the results of F-star GmbHs cash flows for the period ended May 6, 2019, and the years ended December 31, 2018 and 2017.
Period Ended
May 6, |
Year Ended
December 31, |
|||||||||||
2019 | 2018 | 2017 | ||||||||||
(in thousands) | ||||||||||||
Net cash flows (used in) / generated from operating activities |
(2,253 | ) | | 6,680 | (273 | ) | ||||||
Net cash flows generated from/ (used in) investing activities |
127 | (7,518 | ) | (4,217 | ) | |||||||
Net cash flows generated from/ (used in) financing activities |
844 | (217 | ) | 2,079 | ||||||||
Cash and cash equivalents |
| 849 | | 2,053 | | 3,133 |
F-star Beta Limited (F-star Beta)
The following summarizes the results of F-star Betas cash flows for the period ended May 6, 2019, and the years ended December 31, 2018 and 2017
Period Ended
May 6, |
Year Ended
December 31, |
|||||||||||
2019 | 2018 | 2017 | ||||||||||
(in thousands) | (in thousands) | |||||||||||
Net cash used in operating activities |
(£4,621 | ) | (£720 | ) | (£2,959 | ) | ||||||
Net cash used in investing activities |
50 | (1,462 | ) | | ||||||||
Net cash (used in)/ generated from financing activities |
(123 | ) | 5,981 | 2,667 | ||||||||
Cash and cash equivalents |
£ | 915 | £ | 5,709 | £ | 1,910 |
Operating Activities
F-star Therapeutics Limited
During the six month period ended June 30, 2020, operating activities used cash of £1.7 million, resulting from F-stars net loss of £14.0 million, share-based payment expense of £0.9 million, net finance cost of £0.4 million, net exchange loss of £1.3 million, amortization of intangible assets of £0.8 million, depreciation expense on tangible fixed of assets of £0.5 million, £1.5 million of fair value losses on financial liabilities through the profit and loss, £7.0 million corporation tax received offset by £0.7 million increase in trade and other receivables, £0.7 million increase in trade and other payables.
During the six month period ended June 30, 2019, operating activities used cash of £3.7 million, resulting from F-stars net loss of £10.9 million, share-based payment expense of £1.0 million, net exchange loss of £0.2 million, amortization of intangible assets of £0.8 million, depreciation expense on tangible fixed of assets of £0.2 million, loss on disposal of intangible assets of £4.0 million, impairment of intangible assets of £1.8 million, increase in trade payables of £5.4 million, and £8.6 million from proceeds from the sale of intangible assets, offset by £9.5 million decrease in trade and other receivables and £4.7 million decrease in deferred revenue.
During the year ended December 31, 2019, operating activities used cash of £16.6 million, resulting from F-stars net loss of £42.0 million, share-based payment expense of £2.1 million, net exchange gains of £0.2 million, amortization of intangible assets of £1.7 million, depreciation expense on tangible fixed of assets of £0.7 million, loss on disposal of intangible assets of £4.0 million, impairment of intangible assets of £6.6 million, impairment of goodwill of £0.3 million, fair value losses on financial liabilities through profit and loss of £1.1 million, increase in trade payables of £4.4 million, and £8.6 million from proceeds from the sale of intangible assets, £0.2 million decrease in trade and other receivables, and corporation tax received of £0.6 million, offset by a £4.9 million decrease in deferred revenue and a net exchange gain of £0.2 million.
304
F-star (Formerly F-star Delta)
During the year ended December 31, 2018, operating activities generated cash of £12.3 million, resulting from F-star Deltas net profit of £15.9 million, depreciation expense on tangible fixed of assets of £1.1 million, increase in trade payables of £0.2 million, £0.4 million decrease in trade and other receivables, offset by £0.9 million on adoption of a new accounting standard (IFRS 15), and £0.5 million of corporation tax paid.
During the year ended December 31, 2017, operating activities generated cash of £13.6 million, resulting from F-star Deltas net profit of £4.1 million, depreciation expense on tangible fixed of assets of £0.4 million, decrease in trade payables of £1.3 million, £8.5 million decrease in deferred revenue, offset by £0.7 million increase in trade and other receivables.
F-star GmbH
During the period ended May 6, 2019, operating activities used cash of 2.3 million, resulting from F-star GmbHs net profit of 1.4 million, decrease in deferred income of 3.6 million, an increase in trade and other receivables of 1.9 million, foreign exchange gains of 0.2 million, off-set by an increase in trade payables of 1.5 million, depreciation and amortization of 0.5 million and a share based payment charge of 30 thousand.
During the year ended December 31, 2018, operating activities generated cash of 6.7 million, resulting from F-star GmbHs net profit of 1.3 million, adoption of IFRS 15 of 7.0 million, 9.0 million deferred revenue increase, non-cash depreciation and amortization charges of 0.8 million, an increase in trade receivables of 0.4 million, an increase in accounts payable of 0.4 million and corporation tax receivable of 0.6 million.
During the year ended December 31, 2017, operating activities used 0.3 million of cash, resulting from F-star GmbHs net loss of 0.1 million, corporation tax paid of 0.3 million, an increase in accounts receivable of 1.1 million, offset by non-cash depreciation and amortization of 0.6 million and an increase in accounts payable of 0.3 million.
F-star Beta
During the period ended May 6, 2019, operating activities used cash of £4.7 million, resulting from F-star Betas net loss of £0.1 million, decrease in deferred income of £6.0 million, an increase in trade and other receivables of £0.4 million, off-set by an increase in trade payables of £1.1 million, finance costs of £0.1 million and a share-based payment charge of £0.7 million.
During the year ended December 31, 2018, operating activities used £0.7 million of cash, resulting from F-star Betas loss of £1.9 million, a transitional adjustment of £9.3 million to deferred revenue on the adoption of IFRS 15 by F-star Beta, offset primarily by an increase in deferred income of £6.4 million, an increase in accounts payable of £0.6 million, a write off of intangible assets of £0.9 million due to the renegotiation of contracts between F-star Delta and F-star Beta which contract descriptions are included elsewhere in this proxy statement/prospectus, and the subsequent derecognizing of an intangible asset, a corporation tax refund received of £2.3 million due to tax credits on research and development expenditure, £0.1 million adjustment to finance costs, and a £30 thousand adjustment for share-based payments and amortization, and a decrease in receivables by £0.1 million.
During the year ended December 31, 2017, operating activities used £3.0 million of cash, resulting from F-star Betas loss of £0.5 million, adjustments for share-based expense of £0.1 million, finance costs of £0.1 million, an increase of accounts payable of £0.5 million, offset by a £0.3 million increase in receivables and a £2.9 million decrease in deferred income.
Investing Activities
F-star (Formerly F-star Delta)
During the six month periods ended June 30, 2020 and 2019, cash was generated of £8 thousand from interest received, and £4.2 million was acquired from the acquisition of subsidiaries offset by £0.1 million of payments to acquire intangible assets, respectively.
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During the year ended December 31, 2019, net cash generated of £4.1 million was primarily from £4.2 million of cash acquired in business combinations offset by £0.1 million of payments to acquire intangible assets.
During the years ended December 31, 2018 and 2017 investing activities were payments to acquire intangible assets of £9.6 million, and payments to acquire intangible assets of £9.8 million, respectively
F-star GmbH
During the period ended May 6, 2019, net cash generated of 0.1 million from investing activities from proceeds from interest received.
During the years ended December 31, 2018 and 2017 F-star GmbH used 7.5 million and 4.2 million, respectively, of cash in investing activities which consisted of purchases of plant, property and equipment of 0.8 million and 1.0 million respectively, loans issued of 6.9 million to F-star Beta (2.3 million was repaid by F-star Beta and 5.6 million additional loans issued to F-star Beta) respectively, offset by interest received of 0.1 million and 0.1 million, respectively. In the year ended December 31, 2017, 0.1 million was received from the proceeds from sale of assets, and 0.1 million was paid to acquire assets.
F-star Beta
During the period ended May 6, 2019, F-star Beta used cash of £50.0 thousand in investing activities to acquire intangible assets (patents).
During the years ended December 31, 2018 and 2017, F-star Beta used £1.5 million and £Nil, respectively, of cash in investing activities to acquire intangible assets from Iontas of £0.5 million, and £1.0 million from Kymab.
Financing Activities
F-star
During the six month period ended June 30, 2020 net cash generated of £0.2 million was due to £0.4 million proceeds from the convertible debt, off-set by principal elements of lease payments of £0.2 million.
During the six month period ended June 30, 2019 net cash used of £0.1 million was primarily due to £0.1 million of principal elements of lease payments.
During the year ended December 31, 2019, net cash generated of £9.7 million was due primarily to £10.1 million proceeds from the convertible debt, off-set by principal elements of lease payments of £0.3 million.
F-star GmbH
During the period ended May 6, 2019, net cash generated of 0.9 million due to 1.2 million proceeds from loans, off-set by interest paid classified as financing of 0.1 million and lease payments of 0.2 million.
During the years ended December 31, 2018 and 2017, net cash provided by financing activities was 0.2 million generated and 2.1 million used, respectively, in each case consisting of payments of interest paid classified as financing of 0.2 million and 0.2 million, respectively, and in 2017 proceeds from loans of 2.4 million, offset by 0.1 million of loan repayments.
F-star Beta
During the period ended May 6, 2019, net cash generated of £0.1 million due to interest paid of £0.1 million.
During the years ended December 31, 2018 and 2017, net cash provided by financing activities was £6.0 million and £2.7 million, respectively, in each case consisting of £6.1 million and £4.8 million in loans issued to related parties and £2 million in cash receipts from loan payments, respectively, offset by interest expense of £0.1 million and £0.1 million, respectively.
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Contractual Obligations and Commitments
F-star
As at December 31, 2019
Payments Due by Period | ||||||||||||||||||||
Total |
Less than
1 year |
1 to 3
years |
3 to 5
years |
More
than 5 years |
||||||||||||||||
(in thousands) | ||||||||||||||||||||
Contract manufacturing organization |
£ | 735 | £ | 735 | £ | | £ | | £ | | ||||||||||
Finance lease obligations |
505 | 465 | 40 | | | |||||||||||||||
Convertible notes held under FVTPL |
10,838 | 10,838 | | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total contractual obligations and commitments |
£ | 12,078 | £ | 12,038 | £ | 40 | £ | | £ | | ||||||||||
|
|
|
|
|
|
|
|
|
|
As of December 31, 2019, F-star has contracted commitments with a contract manufacturing organization (CMO) as of December 31, 2019 amounting to £0.7 million (2018 and 2017: £nil) for activities that are ongoing or are scheduled to start within 3 to 9 months of the date of the statement of financial position. Under the terms of the agreement with the CMO, the group is committed to pay for some activities if they are cancelled up to 3 to 9 months prior to the star date of the activity.
The finance lease obligations relate to offices and laboratories in Cambridge, United Kingdom.
F-star has convertible loan notes held under FVTPL See Note 21 in F-star audited financial statements for the year ended December 31, 2019 for full details. On July 14, 2020, the convertible notes were modified by extending the expiry date from September 19, 2020 to January 31, 2021. Refer to Note 13 in the F-star unaudited condensed consolidated financial statements as of June 30, 2020 included elsewhere in this proxy statement/prospectus.
F-star operates a bonus plan for its qualifying employees. The plan is settled in cash and is subject to certain financial targets. At December 31, 2019 management does not consider it probable that the financial targets will be met in the foreseeable future. The maximum liability payable under the bonus plan is £1.3 million.
F-star had no significant capital expenditure contracted for, but not recognized as a liability at December 31, 2019 (2018 and 2017: £nil).
F-star adopted IFRS 16 on May 7, 2019, and all leases relating to the offices and laboratories have been brought onto the statement of financial position on that date.
F-star had no significant capital expenditure contracted for, but not recognized as a liability at December 31, 2019 (2018 and 2017: £nil).
As at May 6, 2019
F-star GmbH
Payments Due by Period | ||||||||||||||||||||
Total |
Less than
1 year |
1 to 3
years |
3 to 5
years |
More
than 5 years |
||||||||||||||||
(in thousands) | ||||||||||||||||||||
Balance outstanding between F-star GmbH and F-star Alpha |
| 9,056 | | 9,056 | | | | | | | ||||||||||
Finance lease obligations |
985 | 563 | 422 | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total contractual obligations and commitments |
| 10,041 | | 9,619 | | 422 | | | | | ||||||||||
|
|
|
|
|
|
|
|
|
|
The finance lease obligations relate to office buildings and laboratories in Cambridge, United Kingdom.
F-star GmbH adopted IFRS 16 on January 1, 2019, and all leases relating to the offices and laboratories have been brought onto the statement of financial position on that date.
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As at May 6, 2019
F-star Beta
Payments Due by Period | ||||||||||||||||||||
Total |
Less than
1 year |
1 to 3
years |
3 to 5
years |
More
than 5 years |
||||||||||||||||
(in thousands) | ||||||||||||||||||||
Annual fee payable to Iontas Limited |
£ | 500 | £ | 50 | £ | 100 | £ | 100 | £ | 250 | ||||||||||
Loan payable by F-star Beta to F-star GmbH |
10,048 | 10,048 | | | | |||||||||||||||
Contracts Manufacturing Organization commitment |
7,900 | 7,900 | | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total commitments |
£ | 18,448 | £ | 17,998 | £ | 100 | £ | 100 | £ | 250 | ||||||||||
|
|
|
|
|
|
|
|
|
|
F-star Beta has contracted commitments with a contract manufacturing organization at May 6, 2019 of £7.9 million for activities that are ongoing or are scheduled to start within 3 or 6 months of the statement of financial position date. Under the terms of the agreement with the manufacturing organization F-star Beta is committed to pay for some activities if they are cancelled up to 3 or 6 months prior to the start date of the activity. F-star Beta has no other obligations under non-cancellable operating leases nor significant capital expenditure contracted for, but not recognized as a liability. Pursuant to the Iontas Agreement, F-star Beta is obligated to pay an annual recurring license fee of £50,000.
Critical Accounting Policies and Estimates
F-star (Formerly F-star Delta)
This management discussion and analysis of financial condition and results of operations is based on F-stars consolidated financial statements for the year ended December 31, 2019, which have been prepared in accordance with IFRS as issued by the IASB. The preparation of these financial statements requires F-star to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, F-star evaluates these estimates and judgments. F-star bases its estimates on historical experience and on various assumptions that F-star believes to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. F-star believes that the accounting policies discussed below are critical to understanding F-stars historical and future performance, as these policies relate to the more significant areas involving its judgments and estimates. See Note 2 to the audited financial statements of F-star.
Accounting Acquirer
In accordance with IFRS 3, management determined that the accounting acquirer of the F-star group entities is F-star Delta as the former shareholding F-star Delta was exchanged for the largest proportion of shares in the combined company, and the fair value of the assets of F-star Delta is the largest of the entities involved in this transaction. Further, F-star was not deemed substantive as it was created solely for the purpose of effecting the Corporate Reorgnization.
Management concluded that in accordance with the guidance above, as the former shareholders of F-star Delta received the largest proportion of voting interests in the combined company, F-star Delta is considered the accounting acquirer.
The determination of whether a transaction results in the acquisition of a business or an asset can be judgmental. Management considered a number of factors to determine whether the acquisition of F-star GmbH, F-star Alpha and F-star Beta should each be accounted for as a business combination in accordance with IFRS 3 Business Combinations or an asset acquisition in accordance with IFRS 2 Share-Based Payments. The current definition of a business from IFRS 3 states that a business consists of inputs and processes applied to the inputs that have the ability to create outputs.
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These judgments were based on the following considerations for each entity:
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F-star Alphaholds the intellectual property rights for one early stage clinical molecule, which is not currently being developed. It has no income streams, other than interest income earned on loans to other F-star group entities. F-star Alpha does not employ an organized workforce and does not currently utilize one via any contractual arrangements. In the absence of processes and the ability to generate outputs, the acquisition of F-star Alpha was deemed by management to be an asset acquisition |
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F-star Betaholds the intellectual property rights for several early discovery stage assets and two preclinical assets. Although F-star Beta does not employ its own workforce it has a contracted right to access the workforce of F-star GmbH or the ability to contract with other workforces and has the ability to create outputs via partnering or collaboration arrangements and so was deemed to be a business by management. |
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F-star GmbHholds the intellectual property rights for several non-immuno-oncology assets that are being developed under a collaboration agreement with a partner. F-star GmbH employs its own workforce and the ability to create outputs and as such was deemed a business by management. |
The consideration for the acquisitions of F-star Alpha, F-star Beta, F-star Delta and F-star GmbH was entirely in the form of issued share capital of F-star. In order to determine the value of the consideration, the fair value of the issued equity or asset acquired in each transaction was determined and was deemed to be equal to the fair value of the consideration paid for the issued equity or asset. See Notes 4 and 27 of the audited financial statements of F-star for the year ended December 31, 2019, for the valuation of the issued equity or assets acquired, and managements estimates and judgments.
Collaboration Revenues
F-stars revenues are generated primarily through collaborative arrangements and license agreements with two pharmaceutical companies. The terms of these arrangements may include (i) performing research and development services with the goal of identifying compounds for further development and commercialization, (ii) options to obtain additional research and development services or licenses for additional targets, or to optimize product candidates, upon the payment of option fees, or (iii) the transfer of intellectual property rights (licenses).
The terms of these arrangements typically include payment to F-star of one or more of the following: non-refundable upfront license fees; payments for research and development services; fees upon the exercise of options to obtain additional services or licenses; payments based upon the achievement of defined collaboration objectives; future regulatory and sales-based milestone payments; and royalties on net sales of future products.
F-star recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services.
F-star performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, F-star satisfies the performance obligations. F-star only applies the five-step model to contracts when it is probable that it will collect substantially all of the consideration it is entitled to in exchange for the goods or services it transfers to the customer. As part of the accounting for these arrangements, F-star management must make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation.
F-star assesses the goods or services promised within the contract and determine those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customers discretion are generally considered options. F-star assesses if these options provide a material right to the customer and if so, they are considered performance obligations.
Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. The promised goods or services in F-stars contracts with customers primarily consist of license
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rights to its intellectual property for research and development, research and development services, and options to acquire additional research and development services or options to obtain additional licenses, such as a commercialization license for a potential product candidate. Promised goods or services are considered distinct when: (i) the customer can benefit from the good or service on its own or together with other readily available resources, and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, F-star considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, F-star considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
F-star estimates the transaction price based on the amount of consideration F-star expects to receive for transferring the promised goods or services in the contract. The consideration may include both fixed consideration and variable consideration. At the inception of each arrangement that includes variable consideration, F-star evaluates the amount of the potential payments and the likelihood that the payments will be received. F-star utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration expected to be received. The amount included in the transaction price is constrained to the amount for which it is highly probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, F-star re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts F-stars estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment.
After determining the transaction price, F-star allocates it to the identified performance obligations based on the estimated standalone selling prices. F-star must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. F-star utilizes key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts F-star would expect to receive for each performance obligation.
F-star then recognizes as revenue in the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time based on the use of an output or input method.
Licenses of Intellectual Property: If a license to F-stars intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, F-star recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are combined with other promises, such as research and development services and a research license, F-star utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. F-star evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The measure of progress, and thereby periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the research and development and licensing agreement.
Research and Development Services: The promises under F-stars collaboration agreements may include research and development services to be performed by F-star on behalf of the partner. Payments or reimbursements resulting from its research and development efforts are recognized as the services are performed and presented on a gross basis because F-star is the principal for such efforts.
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Customer Options: F-star evaluates customer options to obtain additional items (i.e., additional license rights) for material rights, or options to acquire additional goods or services for free or at a discount. Optional future services that reflect their standalone selling prices do not provide the customer with a material right and, therefore, are not considered performance obligations and are accounted for as separate contracts. If optional future services reflect a significant or incremental discount, they are material rights, and are accounted for as performance obligations. F-star allocates the transaction price to material rights based on the relative standalone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised or expires.
Milestone Payments: F-stars collaboration agreements may include development and regulatory milestones. F-star evaluates whether the milestones are considered highly probable of being reached and estimate the amounts to be included in the transaction price using the most likely amount method. F-star evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. If it is highly probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within F-stars control or the licensees control, such as marketing approvals, are not considered highly probable of being achieved until those approvals are received. At the end of each reporting period, F-star re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall.
Goodwill
In accordance with IFRS, management used its judgement to allocate the goodwill to each cash generating unit (CGU) representing the lowest level at which goodwill is monitored for internal management purposes, which was determined to be each drug development asset. Goodwill arises as a result of the intellectual input from the workforce and reflects an additional amount that a buyer would pay for the business as acquired as an established business with a highly skilled workforce.
In order to perform an impairment review of goodwill, the goodwill balance relating to each subsidiary acquisition is allocated to CGUs that correspond to the intangible assets acquired (See Note 27 of F-star audited financial statements for the year ended December 31, 2019). Goodwill is allocated on a pro-rata basis, using the fair value on acquisition of the intangible assets acquired.
Impairment of Intangible Assets
Management assesses whether acquired intangible assets have suffered any impairment annually at each reporting date. For the years ended December 31, 2019 and 2018 the recoverable amount of these assets was determined based on value-in-use and fair value less cost of disposal calculations, which requires the use of assumptions and estimates. For assets that are not the subject of partnering agreements the calculations include a cost approach, which utilized net amount invested with a return on investment commensurate with the achievement of certain value inflection events. For partnered assets the calculations include cash flow projections based on financial budgets approved by management covering a three-year period.
Cash flows beyond the three-year period are forecasted using published transition probabilities for development of biological therapeutic molecules, expected clinical study design based upon the clinical development strategy for the pipeline assets and industry analyst sales and gross margin projections for similar molecules in the same target indications.
In the year ended December 31, 2019, due to strategic changes in the asset development plans, a combination of discounted cash flow and cost approach methodologies (employing a return on investment model) have been used to assess the value-in-use and fair value less cost of disposal for intangible assets. The valuation methodology for FS118 and FS131 changed from discounted cash flow in the year ended December 31, 2018 to a cost approach methodology for the year ended December 31, 2019 due to a change from partnered development to a wholly owned asset during the year ended December 31, 2019.
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See Notes 4.7 and 4.8 in the audited financial statements of F-star for the year ended December 31, 2019, for the key assumptions management made with regards to the discount factors used in the value-in-use calculations, and the recoverable amount if this key assumption was to change for partnered and non-partnered assets.
The other assumptions used in the estimation of the recoverable amount are as set out below:
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The values assigned to the assumptions represented managements assessment of the future trends in the relevant industry and have been based on historical data from both external and internal sources. |
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The discount rate which has been estimated based on cost of equity and cost of debt. |
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The cash flow projections included specific development estimates including cost of sales, cost of research & development, probability of success and amount and timing of projected future revenue. |
The recoverable amount would equal the carrying amount if a negative inflection event of 45% were to have occurred in the year ended December 31, 2019. There is no reasonably possible movement in obsolescence that could result in an impairment.
Management has determined the values assigned to each of the above key assumptions as follows:
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Obsolescence factor (Investment) which relates to the cost incurred on an asset in a given year which has been discounted for an estimate of non-productive spend in that year (i.e., expenditure which has not been deemed to have increased the value of the asset). Management assessed this by examining all activities carried out in each year and determining the productivity of each activity. |
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Value inflection events (CMC). These are events that would result in an increase or decrease of the value of an asset. Publicly traded comparable companies were identified that experienced similar events and the equity value was calculated one-day prior to the associated news release, as well as one-day, five-days, 10-days and 30-days post news release to measure the increase or decrease in value. To appropriately manufacture a pharmaceutical or biologic specific manufacturing processes, product characteristics, and product testing must be defined in order to ensure that the product is safe, effective and consistent between batches. These activities are known as CMC, chemistry, manufacturing, and control. |
The table below lists the assets acquired on consolidation from F-star GmbH and F-star Beta, the type of asset acquired, and the methodology used to estimate the fair value at the date of acquisition.
The settlement of pre-existing rights and contracts between the acquired entities and F-star Delta did not result in any settlement gains or losses, but resulted in the addition of intangible assets (see Note 14 of the audited financial statements of F-star for the year ended December 31, 2019) in addition to the assets acquired with F-star Beta and F-star GmbH as listed below.
F-star Beta
Asset |
Asset Type |
Method used to estimate recoverability |
||
FS21 |
Partnered asset |
NPV of probabilityadjusted future cash flows |
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FS120 |
Non-partnered assets |
Cost approach |
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FS222 |
Non-partnered assets |
Cost approach |
F-star GmbH
Asset |
Asset Type |
Method used to estimate recoverability |
||
Partnered Neuroscience assets |
Partnered asset |
NPV of probabilityadjusted future cash flows |
Intangible Assets
In the year ended December 31, 2018, F-star Delta acquired intangible assets that consist of intellectual property rights from a third party that have been sub-licensed to its one external customer; therefore, these have been included in the consolidated financial statements on a carry-over basis. Management estimates the useful life of each asset to be the life of the underlying patents that relate to each asset. However, the actual economic life may be longer than estimated due to potential regional patent term extensions, which are currently unknown.
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Costs Related to Collaborative Arrangements
F-star is an early stage biotechnology company which earns revenues through license and collaboration agreements with two external partners, Denali, and Merck. Costs related to collaborative agreements include all costs incurred which are directly attributable to the research and development activities which generate revenue under these agreements. Where revenue includes the license of perpetual, exclusive intellectual property rights for in-process research and development that has been capitalized, an appropriate amount is charged to the consolidated statement of comprehensive income, based on an allocation of cost or value of the rights that have been licensed, which corresponds to the amount of the intangible asset derecognized from the balance sheet. Cost related to collaborative agreements also include FTE costs and external R&D costs (for subcontracted research and development activities), that have directly derived revenue, and amortization of capitalized intellectual property rights that have been acquired for the purpose of fulfilling the groups obligations under its License and Collaboration agreements. Management judgement is required to estimate the costs that are allocated between costs related to collaborative agreements, and R&D costs.
Convertible Loan Notes
The inputs into the fair value calculations of the convertible notes are classified as level 3 fair values in the fair value hierarchy due to the use of unobservable inputs, including own credit risk.
The different levels have been defined as follows:
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Quoted prices (unadjusted) in active markets for identical assets or liabilities (Level 1) |
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Inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) (Level 2) |
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Inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs) (Level 3) |
The groups finance team performs valuations of financial items for financial reporting purposes, including Level 3 fair values, in consultation with third party valuation specialists for complex valuations. Valuation techniques are selected based on the characteristics of each instrument, with the overall objective of maximizing the use of market-based information. The finance team reports directly to the chief financial officer (CFO) and any significant fair value changes at each reporting date are discussed with the CFO.
The initial fair value of the convertible notes designated at FVTPL has been determined by management as the transaction price, as this is deemed to be at arms length in accordance with the guidance set out in IFRS 13. In determining the fair value on subsequent measurement, management uses its judgment to estimate the probability of the manner in which the group will raise additional funding in the future, which in turn determines the conversion price and value of the derivative embedded in the convertible notes. Fair value was determined using a weighted average percentage probability of various possible scenarios. The key assumption in calculating the fair value of the embedded derivative as at December 31, 2019 was the probability of securing Series B financing of 90% with the balance of probability allocated to no funding and redemption on expiry (in which case the value of the derivative is zero).
The fair value of the embedded derivative if the key assumption were to change by 10% whilst all other assumptions remain constant would be as follows:
Increase probability by 10%: | £0.4 million | |
Decrease probability by 10%: | (£0.4) million |
Share Based Payments
F-star, the parent company of the group, operates an equity-settled, share-based compensation plan, under which it issues equity instruments (share options) of the parent company to employees, consultants, and board members of the group. The fair value of the services received in exchange for the grant of the options is recognized as an expense. The total amount to be expensed is determined by reference to the fair value of the options granted, excluding the impact of any service and non-market performance vesting conditions.
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Non-market performance and service conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all the specified vesting conditions are to be satisfied. At the end of each reporting period, the group revises its estimate of the number of options that are expected to vest based on the non-market vesting and service conditions. It recognizes the impact of the revision to original estimates, if any, in the consolidated statements of comprehensive income, with a corresponding adjustment to equity. The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model.
There are several subjective inputs into the calculation of the charge, the most significant of which is the share price on the date of grant. As an unlisted company this is subject to a significant degree of estimation uncertainty. Management estimates the share price by engaging an independent valuation firm to assess the fair value of the total equity of the group at the date of grant. This is done by valuing the assets and liabilities of the group on either a cost approach or by modelling of the net present value of the future discounted cash flows, depending on whether the asset is being developed by the group with intention to sell or developed under a collaboration agreement with the intention to receive future milestone and royalty payments.
F-star GmbH
While F-star GmbHs significant accounting policies are described in more detail in Note 2 of the consolidated financial statements of F-star GmbH appearing at the end of this prospectus, F-star believes that the following accounting policies are those most critical to the judgments and estimates used in the preparation of F-star GmbHs consolidated financial statements:
Revenue Recognition
F-star GmbHs revenues are generated through its collaborative arrangement with one external collaborator and provision of intellectual property licenses and R&D services to one related party.
The terms of the arrangement with the external collaborator include performing R&D services and the grant of intellectual property rights. In exchange for the initial grant of intellectual property rights and R&D services, F-star GmbH has received non-refundable upfront license payments and is eligible to receive variable consideration in the form of milestone payments that are based on the achievement of defined collaboration objectives.
On inception of a new contract, management identifies performance obligations and consider if these performance obligations are distinct. Performance obligations are promised services in a contract to transfer a distinct service to the customer. Promised services are considered distinct when: (i) the customer can benefit from the service on its own or together with other readily available resources, and (ii) the promised service is separately identifiable from other promises in the contract. In assessing whether promised services are distinct, management considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, management considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
For customer options to acquire intellectual property rights, management assesses if the optional future services are offered at the standalone selling price. If this is the case, then the option is not deemed to provide the customer with a material right and is not considered to be a separate performance obligation. In determining the standalone selling price management consider factors such as identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until the option is exercised or expires, whichever is earliest.
Management estimates the transaction price based on the amount of consideration that the F-star GmbH expects to receive for transferring the promised services in the contract and allocates the transaction price to each performance obligation based upon managements estimate of the standalone selling price. Management must
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develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. Management utilizes key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts the F-star GmbH would expect to receive for each performance obligation.
For variable consideration, F-star GmbH assesses the likelihood that a significant reversal of cumulative revenue will not occur, and amounts are recognized only if it is deemed to be highly probable that reversal will not occur. The Group utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration expected to be received. For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable. When R&D services income, license fees and milestone income are recognized over time, with resource expended to date as a measure of progress of the performance obligations identified in the contract for the following reasons:
|
each performance obligation contains multiple deliverables; and |
|
resource expended has been assessed as the most accurate method of measuring progress towards completion of each performance obligation. |
Impairment of Intangible Assets and Property, Plant and Equipment
At the date of the consolidated statement of financial position, management reviews the carrying amounts of its long-lived assets to determine whether there is any indication that those assets have suffered an impairment loss.
For the purpose of measuring recoverable amounts, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units or CGUs). The recoverable amount is the higher of fair value less cost of disposal and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the estimates of future cash flows have not been adjusted.
If the recoverable amount of an asset is estimated to be less than its carrying amount, the carrying amount of the asset is reduced to its recoverable amount. An impairment loss is recognized as part of operating expenses immediately.
F-star Beta
While F-star Betas significant accounting policies are described in more detail in Note 1 of the financial statements of F-star Beta appearing at the end of this prospectus, F-star believes that the following accounting policies are those most critical to the judgments and estimates used in the preparation of F-star Betas financial statements.
Revenue Recognition
F-star Betas revenues are generated through its intellectual property licensing and service arrangements with one external customer and the provision of intellectual property licenses and research and development (R&D) services to one related party. The terms of the arrangement with the external customer include the performance of R&D services, the grant of intellectual property rights and the option to acquire further intellectual property rights. In exchange for the initial grant of intellectual property rights and R&D services F-star received a non-refundable upfront license payment and will receive variable consideration in the form of milestone payments that are based on the achievement of defined collaboration objectives.
On inception of a new contract management identifies performance obligations and consider if these performance obligations are distinct. Performance obligations are promised services in a contract to transfer a
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distinct service to the customer. Promised services are considered distinct when: (i) the customer can benefit from the service on its own or together with other readily available resources, and (ii) the promised service is separately identifiable from other promises in the contract. In assessing whether promised services are distinct, management considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, management considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
For customer options to acquire intellectual property rights, management assesses if the optional future services are offered at the standalone selling price. If this is the case, then the option is not deemed to provide the customer with a material right and is not considered to be a separate performance obligation. In determining the standalone selling price management consider factors such as identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until the option is exercised or expires, whichever is earliest.
Management estimates the transaction price based on the amount of consideration F-star expects to receive for transferring the promised services in the contract and allocates the transaction price to each performance obligation based upon managements estimate of the standalone selling price. Management must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. Management utilizes key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts F-star would expect to receive for each performance obligation.
For variable consideration, F-star management assesses the likelihood that a significant reversal of cumulative revenue will not occur, and amounts are recognized only if it is deemed to be highly probable that reversal will not occur. F-star utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration expected to be received.
For arrangements that include sales-based royalties and sales-based milestones and in which the license is deemed to be the predominant item to which the royalties relate, F-star recognizes royalty revenue upon the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
For R&D services, the customer pays the fixed amount based on a payment schedule. If the services rendered by F-star Beta exceed the payment received, a contract asset is recognized. If the payments exceed the services rendered, a contract liability (deferred revenue) is recognized.
For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable. When R&D services income, license fees and milestone income are recognized over time, resource expended to date is used as the measure of progress of the performance obligations identified in the contract for the following reasons:
|
each performance obligation contains multiple deliverables; and |
|
resource expended has been assessed as the most accurate method of measuring progress towards completion of each performance obligation. |
Impairment of Intangible Assets
Management assesses whether acquired intangible assets have suffered any impairment at each reporting date, or sooner if there is an indication that the asset may be impaired. For the year ended December 31, 2019 the
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recoverable amount of these assets was determined based on value-in-use calculations or fair value less cost of disposal, which requires the use of assumptions and estimates and a cost approach, which utilized net amount invested with a return on investment commensurate with the achievement of certain value inflection events.
The same methodology was used to estimate the value-in-use or fair value less cost of disposal for each asset at December 31, 2019 as was used to calculate the fair value at the date of acquisition (as per the table in the previous section of this note).
Partnered AssetsDiscounted Cash Flow Approach
In the current year, management have assessed reasonably possible changes for key assumptions included in the impairment model and have concluded that there are no instances that would impact the carrying value of the intangible assets as at December 31, 2019, with the exception of FS21, which was fully impaired during the year.
The key assumptions used in the value-in-use calculations for the year ended December 31, 2019 are as follows:
|
Discount factor: 13.0% |
The key assumptions used in the estimation of the recoverable amount are as set out below:
|
The values assigned to the key assumptions represented managements assessment of the future trends in the relevant industry and have been based on historical data from both external and internal sources. |
|
The discount rate was estimated based on cost of equity and cost of debt. |
The cash flow projections included specific development estimates including cost of sales, cost of R&D, probability of success and amount and timing of projected future revenue.
Non-Partnered AssetsCost Approach
The key assumptions used in the fair value less costs of disposal calculations for the period ended December 31, 2019 are as follows:
Key assumption
FS120 | FS222 | |||||||
Obsolescence factor |
||||||||
2019 investment |
0 | % | 25 | % | ||||
2018 investment |
50 | % | 50 | % | ||||
2017 investment |
80 | % | 80 | % | ||||
Value inflection events |
||||||||
Candidate selection |
3 | % | 3 | % | ||||
Manufacturing process determined |
12.5 | % | 12.5 | % |
The recoverable amount would equal the carrying amount if the key assumptions were to change as follows:
Product candidate FS120
The recoverable amount would equal the carrying amount if a negative inflection event of 61% or an increase in obsolescence to 70% were to have occurred in the year ended December 31, 2019.
Product candidate FS222
The recoverable amount would equal the carrying amount if a negative inflection event of 52% or an increase in obsolescence to 80% were to have occurred in the year ended December 31, 2019.
Off-Balance Sheet Arrangements
The F-star Group Entities did not have during the periods presented, and F-star does not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.
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Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that have impacted, or may impact F-star in the future, financial position and results of operations of F-star, F-star GmbH and F-star Beta are disclosed in Note 2, the New standards, amendments and IFRIC interpretations, to each of the financial statements appearing at the end of this proxy statement/prospectus. Recently issued accounting pronouncements affecting F-star GmbH, F-star Beta and F-star are IFRS 9Financial Instruments and IFRS 15Revenue from Contracts with Customers. IFRS16 Leases affects F-star GmbH and F-star only as F-star Beta has not entered into lease agreements.
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT THE MARKET RISK OF F-STAR
F-star is exposed to market risks in the ordinary course of its business, which are principally limited to foreign currency exchange risk, and interest rate sensitivity.
Foreign Currency Exchange Risk
The functional currency of F-star and F-star Beta is the pound sterling while the functional currency of F-star GmbH is the euro. Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net gain/(loss) for the respective periods. Foreign exchange gains and losses that relate to borrowings and cash and cash equivalents are presented in the statement of comprehensive (loss)/income within finance income or costs. All other foreign exchange gains and losses are presented within other gains in the consolidated statement of comprehensive (loss)/income, as incurred. F-star recorded a foreign exchange gain for the years ended December 31, 2019, 2018 and 2017 of £0.3 million, £0.2 million and £0.1 million, respectively. F-star GmbH recorded a foreign exchange gain for the period ended May 6, 2019 and foreign exchange losses for the years ended December 31, 2018 and 2017 of 0.6 million, 0.1 million and 0.3 million, respectively. F-star Beta for the year ended December 31, 2017 of £0.2 million. There were no foreign exchange gains or losses for F-star Beta recorded a foreign exchange gain for the period ended May 6, 2019 and the year ended December 31, 2018.
Interest Rate Sensitivity
As at June 30, 2020 and December 31, 2019, F-star had cash of £2.2 million and £3.7 million, respectively.
As of May 6, 2019, F-star GmbH and F-star Beta had cash of 0.8 million and £0.9 million, respectively. As of December 31, 2019, F-star had a cash balance of £3.7 million. F-stars exposure to interest rate sensitivity is impacted by changes in LIBOR. Its loans to related parties are subject to interest based on the LIBOR.
As of December 31, 2019, for F-star, and May 6, 2019 for F-star GmbH and F-star Beta, debt is subject to interest rate risk.
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MANAGEMENT FOLLOWING THE EXCHANGE
Executive Officers and Directors
Resignation of Current Executive Officers of Spring Bank
Pursuant to the Exchange Agreement, all of the current executive officers of Spring Bank will resign immediately prior to the completion of the Exchange.
Executive Officers and Directors of the Combined Company Following the Exchange
Spring Banks Board of Directors is currently composed of seven directors. Following the Exchange, the board of directors of the combined company will include a total of eight directors, three of whom will be current directors of Spring Bank and five of whom will be designated by F-star. The following table lists, as of as of September 15, 2020, the names, ages and positions of the individuals who are expected to serve as executive officers and directors of the combined company upon completion of the Exchange:
Name |
Age |
Position |
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Executive Officers |
|
|
|
|
||
Eliot Forster, Ph.D. |
54 | President, Chief Executive Officer and Director | ||||
Darlene Deptula-Hicks |
63 | Chief Financial Officer and Treasurer | ||||
Neil Brewis, Ph.D. |
54 | Chief Scientific Officer | ||||
Louis Kayitalire, M.D. |
63 | Chief Medical Officer | ||||
Non-Employee Directors |
|
|
|
|
||
David Arkowitz |
58 | Director | ||||
Edward Benz, Jr., M.D |
74 | Director | ||||
Nessan Bermingham, Ph.D. |
47 | Director-Chairperson | ||||
Todd Brady, M.D., Ph.D. |
49 | Director | ||||
Pamela Klein, M.D. |
58 | Director | ||||
Patrick Krol |
57 | Director | ||||
Geoffrey Race |
59 | Director |
Executive Officers
Eliot Forster, Ph.D. has served as F-stars Chief Executive Officer since October 2018 and as a member of F-stars Board of Directors since May 2019. Dr. Forster also serves on the boards of directors of F-star Alpha, F-star Beta, F-star Biotechnology, F-star Delta and F-star Therapeutics LLC, in each case from October 2018, and is the sole managing director for F-star GmbH since May 2019. From January 2015 to February 2018, Dr. Forster served as Chief Executive Officer of Immunocore Limited. Prior to that, he served as Chief Executive Officer of Creabilis S.A. (which was subsequently acquired by Sienna Biopharmaceuticals, Inc.) from May 2010 to January 2015. From May 2007 to May 2010, Dr. Forster served as Chief Executive Officer of Solace Pharmaceuticals Inc. Dr. Forster also served as Head of Development and Operations for the European Union and Asia at Pfizer Inc. from 1996 to 2007. Since June 2018, Dr. Forster has served as non-executive chairman of Avacta Group plc, which is publicly traded on the London Stock Exchange. Dr. Forster is an Honorary Visiting Professor of the Pharmacology and Physiology Department at the University of Liverpool, an honorary professor at the University of Pavia (Italy) and a board member of the Office for Strategic Coordination of Health Research, MedCity and the National Genomics Board. He holds a Ph.D. from University of Liverpool, an M.B.A. from Henley Management College, and a B.Sc. with honors from University of Liverpool. Dr. Forster is qualified to serve on the board of directors of the combined company due to his business and technical expertise, along with his strategic insight into F-stars business as its current Chief Executive Officer.
Darlene Deptula-Hicks has served as F-stars Chief Financial Officer since May 2019. Since January 2018, Ms. Deptula-Hicks has operated Crimson Advisors, a strategic and financial consulting services company, and has served as acting Chief Financial Officer for Northern Biologics, Inc. From May 2017 to January 2018, she served as Senior Vice President and Chief Financial Officer of T2 Biosystems, Inc., and from December 2014 to
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February 2017, Ms. Deptula-Hicks was Senior Vice President and Chief Financial Officer of Pieris Pharmaceuticals, Inc. From 2012 until November 2014, she served as Vice President and Chief Financial Officer of Microline Surgical, Inc. Ms. Deptula-Hicks currently serves on the board of directors of Giner Life Sciences and previously served on the board of directors and as audit committee chair of Xentic Biosciences a publicly traded biotechnology company, US Falson, Inc. a privately held defense contractor, Technest Holdings, Inc. a publicly traded defense contracting company and, IMCOR Pharmaceuticals, a publicly traded biotechnology company. Ms. Deptula-Hicks received an M.B.A. from Rivier University and a B.S in Accounting from Southern New Hampshire University.
Neil Brewis, Ph.D. has served as F-stars Chief Scientific Officer since November 2015. He also serves on the board of directors of F-star Therapeutics LLC. From 2007 to October 2015, Dr. Brewis served as Vice President, Head of Biopharmaceuticals Research at GlaxoSmithKline plc. Prior to that, Dr. Brewis served as Head of Research at Domantis Ltd. from 2002 to 2007, when the company was acquired by GlaxoSmithKline plc. Dr. Brewis is an Honorary Doctor of Science from Hertfordshire University. He received a Ph.D. in Biochemistry from Dundee University and a B.Sc. with honors in Applied Biology from Hertfordshire University.
Louis Kayitalire, M.D. Dr. Kayitalire brings over 20 years experience in oncology and immuno-oncology, joining F-star in June 2019 from Bristol-Myers Squibb where he was responsible for the clinical research strategy for broad development of oncology assets and advancing clinical research efforts with a team of medical directors from March 2016 to June 2019. Prior to that, Dr. Kayitalire held senior positions at major pharmaceutical companies including Celgene from September 2013 to March 2016. Dr. Kayitalire completed his medical training at Butare University, Rwanda and later as Assistant Professor in Oncology at the Paris XI University of France. He is an active member of the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR).
Non-Employee Directors
David Arkowitz has been a member of Spring Bank Board since January 2014. Since May 2018, Mr. Arkowitz has served as the Chief Financial Officer and Treasurer of Flexion Therapeutics, Inc., a biotechnology company. Prior to that, Mr. Arkowitz served from September 2013 to May 2018 as Chief Operating Officer and Chief Financial Officer of Visterra, Inc., which was acquired by Otsuka Pharmaceutical Co., Ltd., a biotechnology company. Prior to joining Visterra, he served from 2011 to 2013 as Chief Financial Officer and General Manager at Mascoma Corporation, which was acquired by Lallemand, Inc., a bioconversion company. From 2007 to 2011, Mr. Arkowitz was Executive Vice President, Chief Financial Officer and Chief Business Officer of AMAG Pharmaceuticals, a specialty pharmaceutical company. Prior to his tenure at AMAG, he served as Chief Financial Officer and Treasurer of Idenix Pharmaceuticals, Inc., which was acquired by Merck & Co. Inc., a biopharmaceutical company. Earlier in his career, he spent more than thirteen years at Merck & Co. Inc. including as Vice President and Controller of the U.S. Human Health division and as Controller of the Global Research and Development division. Mr. Arkowitz currently serves on the board of directors of Proteostasis Therapeutics, Inc., a publicly traded biotechnology company, and previously served on the board of directors of Aegerion Pharmaceuticals, Inc., also a publicly traded biotechnology company. Mr. Arkowitz has a BA in Mathematics from Brandeis University and an MBA in Finance from Columbia University Business School. Mr. Arkowitz is qualified to serve on the board of directors of the combined company because he brings more than 20 years of finance and operations leadership experience in the healthcare, life sciences and biotechnology industries.
Todd Brady, M.D., Ph.D. has been a member of Spring Bank Board since July 2016. He currently serves as Chief Executive Officer, President, and Director of Aldeyra Therapeutics, Inc., a publicly traded biotechnology company focused on the development of novel drugs for the treatment of immune-mediated diseases. Dr. Brady was appointed President and Chief Executive Officer of Aldeyra Therapeutics in 2012, having been a member of the board of directors since 2005. Dr. Brady also served as Entrepreneur in Residence at Domain Associates, LLC, a healthcare venture capital firm, where he was a Principal from 2004 to 2013. Dr. Brady also currently serves on the board of directors of Evoke Pharma, Inc., a publicly traded specialty pharmaceutical company, and
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has previously served on the board of directors of Oncobiologics, Inc. and numerous privately traded biotechnology companies. Dr. Brady holds a Ph.D. in pathology from Duke University Graduate School, a M.D. from Duke University Medical School, and an A.B. in Philosophy and Psychology from Dartmouth College. Dr. Brady is qualified to serve on the board of directors of the combined company because of his board of directors experience at other biotechnology companies, as well as his leadership experience in healthcare operations, investing, and research, including his specific experience as president and chief executive officer of Aldeyra Therapeutics, Inc.
Pamela Klein, M.D. has served as a member of Spring Banks Board of Directors since July 2019. Dr. Klein is a principal and founder of PMK BioResearch, which offers strategic consulting in oncology drug development to corporate boards, management teams and the investment community, a position she has held since 2008. From 2009-2011, she served as Chief Medical Officer of Intellikine, which was acquired by Takeda. Previously, Dr. Klein spent seven years at the National Cancer Institute as Research Director of the NCI-Navy Breast Care Center, after which she joined Genentech in 2001. While at Genentech, she held roles of increasing responsibility including Vice President, Development. Dr. Klein currently serves as a member of various scientific advisory boards and also serves on the board of directors of argenx SE and I-Mab Biopharma, both publicly traded biotechnology companies. Dr. Klein is also a board member of Patrys Limited, a biotechnology company located in Australia. Dr. Klein holds a B.A. in biology from California State University and an M.D. from Stritch School of Medicine, Loyola University Chicago, and is trained in internal medicine and medical oncology. Dr. Klein is qualified to serve on the board of directors of the combined company because of her decades of experience with drug development and biotechnology companies.
Edward Benz, Jr., M.D. Dr. Benz joined the F-star Board of Directors in December 2019, and is a renowned leader in the field of oncology with a distinguished career spanning more than 40 years across industry and academia. Dr. Benz has been President and Chief Executive Officer Emeritus of the Dana-Farber Cancer Institute, Boston, MA since October 2016. He has also served as the Richard and Susan Smith Distinguished Professor of Medicine, Professor of Pediatrics, Professor of Genetics and Faculty Dean Emeritus for Oncology at Harvard Medical School since November 2000. Former associate editor of the New England Journal of Medicine, Dr. Benz has authored over 300 peer-reviewed publications and holds several senior positions on various academic boards. He received his Doctor of Medicine from Harvard Medical School and holds an M.A. from Yale University and a B.S. from Princeton University. Dr. Benzs extensive experience in the field of oncology qualifies him to serve on the board of directors of the combined company.
Nessan Bermingham, Ph.D. Dr. Bermingham has served as a member of F-stars Board of Directors and as its chairman since May 2019. Dr. Bermingham previously served as F-stars chairman and on the board of directors of F-star Alpha, F-star Beta and F-star Delta from April 2018 to May 2019. Dr. Bermingham also served as a member of the supervisory board of F-star GmbH until May 2019. Dr. Bermingham currently serves as President, Chief Executive Officer and director of Triplet Therapeutics since November 2018. From May 2014 to December 2017, Dr. Bermingham served as co-founder, President and Chief Executive Officer of Intellia Therapeutics, Inc. Prior to Intellia, from 2002 to 2007 and 2012 to 2014 Dr. Bermingham held various positions at Atlas Ventures including a member of the Atlas Venture Investment Team from 2002 to 2007. Dr. Bermingham received a Ph.D. in Molecular Biology from Imperial College London and received a B.S. from Queens University Belfast. Dr. Berminghams experience in the life sciences industry, as well as his scientific background, qualifies him to serve on the board of directors of the combined company.
Patrick Krol. Mr. Krol has served on F-stars Board of Directors since May 2019 and served on the board of directors of F-star Alpha, F-star Beta and F-star Delta from their respective incorporation dates to May 2019. Mr. Krol also served as a member of the supervisory board of F-star GmbH until May 2019. Mr. Krol joined venture capital fund Aescap Venture in 2005 and has served as a Managing Director since 2011. In 2016, Mr. Krol founded Aescap 2.0, a biotech fund investing in public biotechnology companies, for which he acts as Portfolio Manager. From 1995 until 2004, Mr. Krol was the founder and Managing Director of Firm United Healthcare. Mr. Krol currently serves on the board of directors of a number of private companies and is a director at Shire International Licensing BV, a subsidiary of Shire Plc, since 2004. Mr. Krol received an M.B.A. in Executive Management and Consultancy from Lemniscaat Management School, a M.Sc. from Business School
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Netherlands and a B.A. from Hogeschool Utrecht. Mr. Krols experience with healthcare ventures, as well as his experience serving as a director of other life sciences companies, qualifies him to serve on the board of directors of the combined company.
Geoffrey Race. Mr. Race joined the F-star Board of Directors in December 2019. Mr. Race brings more than 20 years of experience at both the Chief Financial and Chief Executive Officer level in the life sciences industry. Mr. Race is the Executive Vice President, Chief Financial Officer and Chief Business Officer of Minerva Neurosciences Inc. (NASDAQ:NERV), a company he co-founded in 2013 through the merger of Cyrenaic Inc. and Sonkei Inc. Previously, in September 2011, Mr. Race was appointed Chief Executive Officer of Funxional Therapeutics Ltd, an early-stage research company focused on the treatment of inflammatory diseases. Funxionals lead program was licensed to Boehringer Ingelheim in 2013. Prior to this role, Mr. Race was Chief Financial Officer of PanGenetics BV, which included clinical stage companies developing NGF and CD-40 antibodies, part of which was sold to Abbott Laboratories in 2009. Mr. Race received an MBA from Durham University Business School, UK, and is a Fellow of the Chartered Institute of Management Accountants. Mr. Races financial experience in the life sciences industry qualifies him to serve on the board of directors of the combined company.
Composition of the Board of Directors
Spring Banks Board of Directors is currently comprised of seven directors divided into three staggered classes, each class serving three-year terms. The staggered structure of Spring Banks Board of Directors will remain in place following completion of the Exchange. At the most recent annual meeting of Spring Banks stockholders held in 2020, Class II directors were elected. As a result, the term of the Class II directors of the combined company will expire upon the election and qualification of successor directors at the annual meeting of stockholders in 2023, with the terms of the Class I directors and Class III directors expiring upon the election and qualification of successor directors at the annual meetings of stockholders to be held in 2022 and 2021, respectively.
The director classes for Spring Bank are currently as follows:
|
Class I consists of Pamela Klein, M.D. and Timothy Clackson, Ph.D., each with a term expiring at the 2022 annual meeting of stockholders; |
|
Class II consists of David Arkowitz and Kurt Eichler, each with a term expiring at the 2023 annual meeting of stockholders; and |
|
Class III consists of Todd Brady, M.D., Ph.D., Martin Driscoll and Scott Smith each with a term expiring at the 2021 annual meeting of stockholders. |
Pursuant to the Exchange Agreement, each of the directors and officers of Spring Bank who will not continue as directors or officers of the combined company following the Exchange will resign immediately prior to the Closing. Pursuant to the terms of the Exchange Agreement, five directors of the board of directors of the combined company will be designated by F-star and three directors will be designated by Spring Bank. It is anticipated that these directors will be appointed to the three staggered director classes of the combined companys board of directors as follows:
|
Class I will consist of Pamela Klein, M.D., Patrick Krol, and Geoffrey Race, each with a term expiring at the 2022 annual meeting of stockholders. |
|
Class II will consist of David Arkowitz, Nessan Bermingham, Ph.D., and Eliot Forster, Ph.D., each with a term expiring at the 2023 annual meeting of stockholders. |
|
Class III will consist of Todd Brady, M.D., Ph.D. and Edward Benz, Jr., M.D., each with a term expiring at the 2021 annual meeting of stockholders. |
The division of the Spring Bank Board into three classes with staggered three-year terms may delay or prevent a change of management or a change of control of Spring Bank, or, following the completion of the Exchange, the combined company.
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Committees of the Board of Directors
After completion of the Exchange, the combined companys board of directors will have an Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee.
Audit Committee
The responsibilities of the Audit Committee will include:
|
appointing, overseeing, and if need be, terminating any independent auditor; |
|
assessing the qualification, performance and independence of its independent auditor; |
|
reviewing the audit plan and pre-approving all audit and non-audit services to be performed by its independent auditor; |
|
reviewing its financial statements and related disclosures; |
|
reviewing the adequacy and effectiveness of its accounting and financial reporting processes, systems of internal control and disclosure controls and procedures; |
|
reviewing Spring Banks overall risk management framework; |
|
overseeing procedures for the treatment of complaints on accounting, internal accounting controls, or audit matters; |
|
reviewing and discussing with management and the independent auditor the results of Spring Banks annual audit, reviews of its quarterly financial statements and its publicly filed reports; |
|
reviewing and approving related person transactions; and |
|
preparing the audit committee report that the SEC requires in its annual proxy statement. |
Following completion of the Exchange, the members of the Audit Committee are expected to be David Arkowitz, Geoffrey Race and Todd Brady. Mr. Arkowitz is expected to be the Chair of the Audit Committee and an Audit Committee financial expert as defined in Item 407(d)(5) of Regulation S-K. Spring Bank and F-star believe that, after completion of the Exchange, the Audit Committee will comply with the applicable requirements of the rules and regulations of the Nasdaq Stock Market LLC and the SEC.
Compensation Committee
The responsibilities of the Compensation Committee will include:
|
reviewing the elements and amount of total compensation for all executive officers; |
|
formulating and recommending any proposed changes in the compensation of Spring Banks chief executive officer for approval by the Board; |
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reviewing and approving any changes in the compensation for executive officers, other than Spring Banks chief executive officer; |
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administering Spring Banks equity compensation plans; |
|
reviewing annually Spring Banks overall compensation philosophy and objectives, including compensation program objectives, target pay positioning and equity compensation; and |
|
preparing the compensation committee report that the SEC will require in Spring Banks annual proxy statement, if applicable. |
Following completion of the Exchange, Spring Banks Compensation Committee is expected to consist of Geoffrey Race and Nessan Bermingham, Ph.D. Mr. Race is expected be the Chair of the Compensation Committee. Spring Bank and F-star believe that each member of the Compensation Committee will be a non-employee director within the meaning of Rule 16b-3 of the rules promulgated under the Exchange Act and independent within the meaning of the independent director guidelines of the Nasdaq Stock Market LLC.
Compensation Committee Interlocks and Insider Participation
It is expected that none of the proposed executive officers of the combined company will serve as a member of the board of directors or compensation committee of any entity that has one or more executive officers who is
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proposed to serve on the combined companys board of directors or Compensation Committee following the Exchange.
Nominating and Corporate Governance Committee
The responsibilities of the Nominating and Corporate Governance Committee will include:
|
evaluating and making recommendations regarding the composition, organization and governance of the Spring Bank Board and its committees; |
|
identifying, recruiting and nominating director candidates to the Spring Bank Board if and when necessary; |
|
evaluating and making recommendations regarding the creation of additional committees or the change in mandate or dissolution of committees; |
|
reviewing and making recommendations with regard to its corporate governance guidelines and compliance with laws and regulations; and |
|
reviewing and approving conflicts of interest of its directors and corporate officers, other than related person transactions reviewed by the Audit Committee. |
Following completion of the Exchange, the members of the Nominating and Corporate Governance Committee are expected to be Nessan Berminham, Ph.D. and Pamela Klein, M.D. Dr. Bermingham is expected be the chairman of the Nominating and Corporate Governance Committee. Spring Bank and F-star believe that each member of the Nominating and Corporate Governance Committee will be independent within the meaning of the independent director guidelines of the Nasdaq Stock Market.
Current Spring Bank Director Compensation
Spring Banks Board of Directors adopted a formal non-employee director compensation policy that became effective upon its initial public offering in May 2016 and which was amended most recently in January 2019 with the assistance of Radford, Aon Hewitt, a business unit of Aon plc (Radford), as its independent compensation consultant. Under Spring Banks current non-employee director compensation program, Spring Bank pays its non-employee directors, including Mr. Arkowitz and Drs. Brady and Klein, annual retainers in cash. Each non-employee director receives an annual cash retainer for service on the Spring Bank Board and for service on each committee on which the director is a member. The chairmen of each committee receive higher annual retainers for such service. These fees are paid quarterly in arrears. The fees payable to non-employee directors for service on the Spring Bank Board and for service on each committee of the Spring Bank Board on which the director was a member during the fiscal year ended December 31, 2019 were as follows:
Member
Annual Fee |
Chairman
Annual Fee |
|||||||
Board of Directors |
$ | 37,500 | $ | 67,500 | (1) | |||
Audit Committee |
$ | 7,500 | $ | 15,000 | ||||
Compensation Committee |
$ | 5,000 | $ | 10,000 | ||||
Nomination and Corporate Governance Committee |
$ | 4,000 | $ | 8,000 | ||||
Science and Technology Committee |
$ | 4,000 | $ | 8,000 |
(1) |
The Chairman of Spring Banks Board of Directors only receives a retainer for such service if he or she is a non-employee director. |
Spring Banks non-employee director compensation program includes a stock-for-fees policy, under which directors have the right to elect to receive common stock in lieu of cash fees. These shares of common stock are issued under Spring Banks Amended and Restated 2015 Stock Incentive Plan (the 2015 Plan). The number of shares issued to participating directors is determined on a quarterly basis by dividing the cash fees to be paid through the issuance of common stock by the fair market value of Spring Bank common stock, which is the closing price of Spring Bank common stock on the last business day of the quarter in which the fees are earned.
Under Spring Banks non-employee director compensation program, upon their initial election to the Spring Bank Board, each new non-employee director receives an initial option grant to purchase 15,000 shares of Spring
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Bank common stock, which vests in equal monthly installments over a term of three years so long as such person continues to serve as a director, and all non-employee directors will receive an annual option grant to purchase 7,500 shares of its common stock, which vests in equal monthly installments over a term of one year so long as such person continues to serve as a director. The annual grants are made on the date of its annual meeting of stockholders. These options are granted under the 2015 Plan with exercise prices equal to the fair market value of Spring Banks common stock, which is the closing price of its common stock, on the date of grant. Outstanding options held by Spring Bank non-employee directors will become immediately exercisable in full immediately prior to the Exchange.
Spring Bank also reimburses its non-employee directors for reasonable travel and other expenses incurred in connection with attending Spring Bank Board of Director and committee meetings.
Spring Bank 2019 Non-Employee Director Compensation Table
The Compensation of the members of the Spring Bank Board who are expected to be members of the board of directors of the combined company for the year ended December 31, 2019 is set forth below.
Name |
Fees Earned or
Paid in Cash ($)(1) |
Stock
Awards ($) |
Option
Awards ($)(2) |
Total
($) |
||||||||||||
David Arkowitz |
| 57,500 | 22,952 | 80,452 | ||||||||||||
Todd Brady, M.D., Ph.D. |
| 49,500 | 22,952 | 72,452 | ||||||||||||
Pamela Klein, M.D.(3) |
19,735 | | 45,904 | 65,639 |
(1) |
Reflects payment of annual fees for Board and committee service from January 1 to December 31 in fully vested shares of Spring Bank common stock. As of December 31, 2019, Spring Banks non-employee directors did not hold any shares under outstanding stock awards. |
(2) |
These amounts reflect the aggregate grant date fair value of option awards in 2019 computed in accordance with FASB ASC Topic 718. Assumptions used in the calculation of these amounts are included in Note 8 to Spring Banks consolidated financial statements included in Spring Banks Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 14, 2020. As of December 31, 2019, Mr. Arkowitz held options to purchase 34,000 shares of Spring Bank common stock, Dr. Brady held options to purchase 29,500 shares of Spring Bank common stock, and Dr. Klein held options to purchase 15,000 shares of Spring Bank common stock. |
(3) |
Pamela Klein, M.D. was elected to the Spring Bank Board on July 10, 2019. |
Director Compensation Following the Exchange
For the fiscal year ended December 31, 2019, F-star did not have a director compensation policy in place. However, F-star has provided cash and/or equity-based compensation to its non-employee directors for the time and effort necessary to serve as a member of F-stars board of directors. In addition, F-star has historically provided reimbursement for reasonable out-of-pocket expenses incurred for attending meetings of the F-star Board of Directors.
The following table provides information concerning the compensation of each non-employee director who served on F-stars board of directors in 2019. F-star employees do not receive compensation for serving as directors, and accordingly, Dr. Forster did not receive any compensation for his service as a director.
Name |
Fees Earned or
Paid in Cash ($) |
Option
Awards ($)(2) |
Total
($) |
|||||||||
Edward Benz, Jr. M.D.(1) |
$ | 1,485 | $ | 75,226 | $ | 76,711 | ||||||
Nessan Bermingham, Ph.D. |
$ | 107,584 | $ | 651,693 | $ | 759,277 | ||||||
Patrick Krol |
| | | |||||||||
Geoffrey Race(1) |
$ | 1,485 | $ | 108,449 | $ | 109,934 |
(1) |
Dr. Benz and Mr. Race were elected to the F-star Board of Directors on December 18, 2019. |
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(2) |
These amounts reflect the aggregate grant date fair value of option awards in 2019. Assumptions used in the calculation of these amounts are included in the notes to F-stars consolidated financial statements. As of December 31, 2019, Mr. Bermingham held options to purchase 303,211 F-star ordinary shares, Dr. Benz held options to purchase 35,000 F-star ordinary shares, and Mr. Race held options to purchase 35,000 F-star ordinary shares. |
Following completion of the Exchange, it is expected that the combined organization will provide compensation to non-employee directors under a 2020 Non-Employee Director Compensation Policy (the 2020 Director Compensation Policy), as described below. However, these director compensation policies may be re-evaluated by the combined organization and the compensation committee following completion of the Exchange and may be subject to change. Non-employee directors are expected to receive an annual retainer fee and equity compensation in the form of a stock option grant.
Under the 2020 Director Compensation Policy, the annual retainer for non-employee directors is expected to be $42,500. Annual retainers for the Chair of the Board and committee memberships are expected to be as follows:
Board Chair |
$ | 75,000 | ||
Audit Committee Chairperson |
$ | 16,500 | ||
Audit Committee member |
$ | 8,000 | ||
Compensation Committee Chairperson |
$ | 12,500 | ||
Compensation Committee member |
$ | 6,500 | ||
Nominating and Corporate Governance Committee Chairperson |
$ | 9,000 | ||
Nominating and Corporate Governance Committee member |
$ | 4,500 |
In addition to the above fees, the board of directors of the combined company may determine that additional committee fees are appropriate and should be payable for any newly created committee of the board of the combined company.
Under the terms of the 2020 Director Compensation Policy, each newly appointed non-employee director is expected to be granted a non-qualified stock option to purchase 35,000 shares of Spring Bank common stock under Spring Banks 2015 Plan at the first regularly scheduled meeting of the Board on or after his or her initial appointment or election to the Board. In addition, annually, each incumbent non-employee director who has served as a director for at least six (6) months is expected to be granted a non-qualified stock option to purchase 20,000 shares of Spring Bank common stock under the 2015 Plan on the date of the annual meeting of stockholders. F-star directors joining the Spring Bank Board as of the Closing will not receive an initial option grant under the 2020 Director Compensation Policy and are expected to receive annual option grants beginning in 2021. Under the 2020 Director Compensation Policy, non-employee directors may also elect to receive their annual fees for Board and committee service for a given year in the form of vested shares of Spring Bank common stock (based on the fair market value of Spring Bank common stock).
Unless otherwise specified by the board of directors or the compensation committee at the time of grant, all options granted under the 2020 Director Compensation Policy are expected to: (i) vest in twelve equal monthly installments at the end of each successive month following the grant date until the first anniversary of the grant date, in each case subject to the non-employee directors continued service on the board of directors; (ii) have an exercise price equal to the fair market value of Spring Banks common stock as determined in the 2015 Plan on the grant date; (iii) terminate ten years after the grant date; (iv) accelerate in full upon the occurrence of a Change in Control (as defined in the 2020 Director Compensation Policy); and contain such other terms and conditions as set forth in the form of option agreement approved by the Board or the Compensation Committee prior to the grant date. Option grants under the 2020 Director Compensation Policy are subject to the limitation in the 2015 Plan providing that the number of shares to be granted to any non-employee director under the 2015 Plan in any calendar year may not exceed the lesser of (i) 20,000 shares or (ii) awards having an aggregate grant date fair value of $200,000, except that the foregoing limitation shall not apply to awards made pursuant to an election by a non-employee director to receive the award in lieu of cash for all or a portion of cash fees to be received for service on the Board or any committee thereof.
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Upon presentation of documentation of expenses reasonably satisfactory to the combined company, non-employee directors will be reimbursed for their reasonable expenses incurred in connection with attending board of directors and committee meetings.
Following the Closing and in accordance with the 2020 Director Compensation Policy, the combined company will not provide additional compensation to non-employee directors, other than as reimbursement for reasonable expenses incurred in connection with attending board and committee meetings or unless this additional compensation is in exchange for bona fide services or is otherwise reviewed and approved in accordance with combined companys policy regarding related person transactions.
F-star Executive Compensation
F-stars named executive officers, consisting of its principal executive officer and the next two most highly compensated executive officers, for the fiscal year ended December 31, 2019 were:
Name |
Title |
|
Eliot Forster, Ph.D. |
Chief Executive Officer and Director | |
Darlene Deptula-Hicks |
Chief Financial Officer |
|
Neil Brewis, Ph.D. |
Chief Scientific Officer |
Following the Closing, F-stars named executive officers are expected to continue to be the executive officers named above.
The following table sets forth information regarding compensation earned with respect to the year ended December 31, 2019 by F-stars principal executive officer and the next two most highly compensated executive officers in 2019, whom F-star refers to as its named executive officers for 2019.
Name and Principal Position |
Year | Salary | Bonus(1) |
Option
awards(5) |
All other
compensation(2) |
Total | ||||||||||||||||||
Eliot Forster, Ph.D.(3)(4) |
2019 | $435,625 | $ | $1,054,659 | $58,212 | $1,458,486 | ||||||||||||||||||
Chief Executive Officer | ||||||||||||||||||||||||
Darlene Deptula-Hicks |
2019 | $327,125 | | $543,035 | | $870,160 | ||||||||||||||||||
Chief Financial Officer | ||||||||||||||||||||||||
Neil Brewis, Ph.D.(4) |
2019 | $229,587 | $31,250 | $236,408 | $2,867 | $500,112 | ||||||||||||||||||
Chief Scientific Officer |
(1) |
Any discretionary bonuses for Drs. Forster and Brewis and Ms. Deptula-Hicks for services in 2019 have yet to be determined or paid. Dr. Brewis received a retention bonus in 2019. |
(2) |
Includes company contributions to the F-star defined pension contribution scheme and F-star 401(k) plan, as applicable. |
(3) |
Dr. Forster is also a member of F-stars board of directors, but did not receive any additional compensation in his capacity as a director. |
(4) |
Salary payments to Drs. Forster and Brewis were paid in British pounds and converted to U.S. dollars using an exchange rate of 1.28 on December 31, 2019. |
(5) |
These amounts reflect the aggregate grant date fair value of option awards in 2019. Assumptions used in the calculation of these amounts are included in the notes to F-stars consolidated financial statements. As of December 31, 2019, Dr. Forster held options to purchase 340,374 F-star ordinary shares, Dr. Brewis held options to purchase 76,297 F-star ordinary shares, and Ms. Deptula-Hicks held options to purchase 252,656 F-star ordinary shares. |
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Outstanding Equity Awards at December 31, 2019
The following table sets forth certain information about outstanding equity awards granted to F-stars named executive officers outstanding as of December 31, 2019.
Option awards(1) | ||||||||||||||||||||
Name |
Vesting
start date |
Number of
securities underlying unexercised options (#) exercisable |
Number of
securities underlying unexercised options (#) unexercisable |
Option exercise
price |
Option
expiration date |
|||||||||||||||
Eliot Forster, Ph.D. |
10/1/2018 | 17,194 | (2) | 33,377 | GBP 0.00017006 | 6/14/29 | ||||||||||||||
10/1/2018 | 98,533 | (2) | 191,270 | £0.01 | 6/14/29 | |||||||||||||||
Darlene Deptula-Hicks |
5/1/2019 | | (2) | 252,676 | $1.87 | 6/14/29 | ||||||||||||||
Neil Brewis, Ph.D. |
11/2/2015 | 20,229 | (2) | | GBP 0.00042514 | 11/2/25 | ||||||||||||||
5/7/2019 | | (2) | 56,068 | £0.01 | 6/14/29 |
(1) |
All of the option awards listed in the table above were granted under the F-star EIP, the terms of which are described below under Equity incentive plans. |
(2) |
The options vest as to 28% of the total shares on the first anniversary of the vesting start date and 2% on the last day of each month subsequent to such first anniversary until the option is fully vested on the fourth anniversary, subject to the holders continued service through the applicable vesting date. |
In July 2020, F-star granted options under the F-star EIP to purchase 2,030,000 and 625,000 shares, respectively to each of Drs. Forster and Brewis. The options were granted with exercise prices equal to £0.01, and vest as to 25% of the total shares underlying shares on the first anniversary of the grant date, with the remainder vesting in equal monthly installments over the ensuing 36 months, subject to the holders continued service through the applicable vesting date. In July 2020, F-star also granted a restricted stock unit award under the F-star EIP representing 235,000 shares to Ms. Deptula-Hicks. The RSUs vest as to 25% of the total shares underlying shares on the first anniversary of the grant date, with the remainder vesting in equal monthly installments over the ensuing 36 months, subject to the holders continued service through the applicable vesting date. The terms of the F-star EIP are described below under Equity Compensation Arrangements. In the future, on an annual basis or otherwise, the combined company may grant additional equity awards to F-stars executive officers.
Employment and Consulting Arrangements
Below is a description of F-stars employment or consulting agreements, as applicable, with each of F-stars named executive officers for the fiscal year ended December 31, 2019.
Eliot Forster, Ph.D. F-star entered into an employment agreement with Dr. Forster in October 2018, which was amended in July 2020, setting forth the terms of his employment. Dr. Forster was entitled to an initial annual base salary of £425,000 ($544,000), which has been subsequently increased, most recently as of March 1, 2019, to £437,750 ($560,000). The agreement provides for an annual discretionary bonus of a maximum of 50% of his annual base salary, taking into account specific performance targets conveyed to Dr. Forster from time to time. Dr. Forster is eligible to receive either (i) a one-time success bonus of £75,000 ($98,160), subject to and on completion of a reverse merger and a further £75,000 ($98,160) upon completion of a fund-raise of at least £40,000,000 ($52,352), or (ii) a one-time success bonus of £75,000 ($98,160), subject to and upon completion of a mezzanine financing of £40,000,000 ($52,352) or more, and a further £75,000 ($98,160) upon completion of an F-star U.S. public listing. Dr. Forster is entitled to participate in any F-star group personal pension scheme and F-star will provide for life insurance benefits in an amount equal to four times Dr. Forsters current annual salary. In the event Dr. Forster is unable to perform his duties due to incapacity, he is generally entitled to receive his full salary and benefits during any period of absence for up to a maximum of 26 weeks in any 52-week period. The agreement may be terminated by either party by giving six months notice, provided that F-star may terminate the agreement at any time by paying Dr. Forster a lump sum payment equal to his base salary in lieu of
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all or any portion of the amount that would be paid during the required notice period. The agreement may also be terminated by F-star immediately under circumstances that constitute cause as set forth in the agreement. Dr. Forster is entitled to a sum equal to 18 months base salary, in the event of a Qualifying Termination (as defined in the employment agreement) within the 12 month period following a Change of Control (as defined in the employment agreement, and which does not include the Exchange) or a sum equal to 12 months base salary, in the event of a Qualifying Termination more than 12 months following a Change of Control. Severance sums may be offset by notice periods. In addition, in the event of a Qualifying Termination within 12 months of a Change of Control, all options and RSUs not assumed by an acquirer will vest in full. Under the employment agreement, Dr. Forster is subject to certain non-competition provisions for a period of 12 months following termination of employment or garden leave.
Darlene Deptula-Hicks. F-star entered into a consulting agreement with Ms. Deptula-Hicks effective as of May 1, 2019 setting forth the terms of her arrangement to serve, inter alia, as F-stars chief financial officer. Pursuant to the agreement, Ms. Deptula-Hicks is entitled to an hourly consulting fee of $250.00 plus reimbursement for all reasonable and necessary expenses incurred by Ms. Deptula-Hicks in providing the services under the agreement. Pursuant to the agreement, Ms. Deptula-Hicks was granted a stock option to purchase 252,676 F-star ordinary shares in June 2019, under which 25% of the shares underlying the option would vest after 12 months of employment, and the remaining shares underlying the option would vest in equal monthly installments over 36 months, subject to Ms. Deptula-Hicks continued service. Ms. Deptula-Hicks is eligible to receive each of (i) a one-time success fee of $50,000, subject to and on completion of a financing prior to or contemporaneously with the completion of the Exchange Agreement and (ii) a one-time success fee of $50,000, subject to and upon completion of an F-star U.S. public listing. The term of the agreement was for twelve months and the agreement automatically renews at the end of the term for additional twelve-month periods unless terminated with 90 days notice prior to the end of the consulting period, or unless earlier terminated without cause upon 90 days notice or immediately for cause (as defined in the agreement). Ms. Deptula-Hicks is not entitled to any additional consulting fees or other compensation as of the date of termination.
Neil Brewis, Ph.D. F-star entered into an employment agreement with Dr. Brewis in October 2015, which was amended in July 2020, setting forth the terms of his employment as F-stars chief scientific officer. Dr. Brewis was entitled to an initial annual base salary of £185,000 ($236,800), which has been subsequently increased, most recently as of October 1, 2019, to £250,000 ($320,000). Dr. Brewis agreement provides for an annual discretionary bonus of a maximum of 40% of his annual base salary, taking into account specific performance targets conveyed to Dr. Brewis from time to time. Dr. Brewis is entitled to participate in any F-star group personal pension scheme and F-star will provide for life insurance benefits in an amount equal to four times Dr. Brewis current annual salary. In the event Dr. Brewis is unable to perform his duties due to incapacity, he is generally entitled to receive his full salary and benefits during any period of absence for up to a maximum of 26 weeks in any 52-week period. The agreement may be terminated by either party by giving six months notice, provided that F-star may terminate the agreement at any time by paying Dr. Brewis a lump sum payment equal to his base salary in lieu of all or any portion of the amount that would be paid during the required notice period. The agreement may also be terminated by F-star immediately under circumstances that constitute cause as set forth in the agreement. Dr. Brewis is entitled to a sum equal to 12 months base salary, in the event of a Qualifying Termination (as defined in the employment agreement) within the 12 month period following a Change of Control (as defined in the employment agreement and which does not include the Exchange) or a sum equal to 9 months base salary, in the event of a Qualifying Termination more than 12 months following a Change of Control. Severance sums may be offset by notice periods. In addition, in the event of a Qualifying Termination within 12 months of a Change of Control, all options and RSUs not assumed by an acquirer will vest in full. Under the employment agreement, Dr. Brewis is subject to certain non-competiton provisions for a period of 12 months following termination of employment or garden leave.
Post-Business Combination Company Executive Compensation
Following the Closing, F-star expects to develop an executive compensation program that is designed to align compensation with F-stars business objectives and the creation of stockholder value, while enabling F-star
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to attract, motivate and retain individuals who contribute to the long-term success of F-star. Decisions on the executive compensation program will be made by the compensation committee of the board of directors.
2019 Bonuses
Each of F-stars executive officers were eligible to receive bonuses with respect to their services in 2019 in the discretion of F-stars board of directors. The bonus structure is designed to motivate and reward executives for the attainment of personal and company-wide goals. The annual cash bonus target for Dr. Forster was set at 35% of his then-effective base salary £153,213 ($200,526) for 2019. The annual cash bonus target for Dr. Brewis was set at 25% of his then-effective base salary £62,500 ($81,801) for 2019. F-stars named executive officers are eligible to receive more than 100% of their target bonuses in the discretion of F-stars board of directors. Any discretionary bonuses for Drs. Forster and Brewis and Ms. Deptula-Hicks for services in 2019 have yet to be determined or paid.
Nonqualified Deferred Compensation
None of F-stars named executive officers for the fiscal year ended December 31, 2019 participated in or have account balances in nonqualified defined contribution plans or other nonqualified deferred compensation plans maintained by F-star. F-stars board of directors may elect to provide F-stars officers and other employees with nonqualified defined contribution or other nonqualified deferred compensation benefits in the future if it determines that doing so is in F-stars best interests.
Pension Scheme
F-star maintains a defined contribution retirement plan that provides eligible U.K. employees with an opportunity to save for retirement on a tax advantaged basis. Eligible employees may sacrifice eligible compensation on a pre-tax basis, up to the statutorily prescribed annual limits on contributions as defined by HMRC. Contributions are allocated to each participants individual account and are then invested in selected investment alternatives according to the participants directions. F-star contributes the equivalent to 8% of employees pensionable compensation, requiring employees to contribute 1% to meet auto enrollment requirements.
401(k) Plan
F-star maintains a defined contribution retirement plan that provides eligible U.S. employees with an opportunity to save for retirement on a tax advantaged basis. Eligible employees may defer eligible compensation on a pre-tax basis, up to the statutorily prescribed annual limits on contributions under the Code. Contributions are allocated to each participants individual account and are then invested in selected investment alternatives according to the participants directions. F-star contributes a safe harbor minimum contribution equivalent to 3% of employees compensation. Employees are immediately and fully vested in their contributions. The 401(k) plan is intended to be qualified under Section 401(a) of the Code with the 401(k) plans related trust intended to be tax exempt under Section 501(a) of the Code. As a tax-qualified retirement plan, contributions to the 401(k) plan and earnings on those contributions are not taxable to the employees until distributed from the 401(k) plan.
Health and Welfare Benefits
All of F-stars full-time employees and certain of F-stars part-time employees are eligible to participate in F-stars employee benefit plans, including F-stars medical, dental, life and disability insurance plans, in each case on the same basis as all of F-stars other employees.
Rule 10b5-1 Sales Plans
The directors and executive officers of F-star may adopt written plans, known as Rule 10b5-1 plans, in which they will contract with a broker to buy or sell shares of the combined companys common stock on a periodic basis. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the director or executive officer when entering into the plan, without further direction from them. The director or
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executive officer may amend a Rule 10b5-1 plan in some circumstances and may terminate a plan at any time. F-stars directors and executive officers also may buy or sell additional shares outside of a Rule 10b5-1 plan when they are not in possession of material nonpublic information subject to compliance with the terms of the combined organizations insider trading policy. Prior to 180 days after the date of the Closing, the sale of any shares under such plan would be subject to the lock-up agreement that the director or executive officer has entered into as a condition to the Closing.
Equity Compensation Arrangements
2019 Equity Incentive Plan
The F-star EIP, which was adopted on May 7, 2019 together with a Non-Employee Sub-Plan, a Company Share Option Plan (CSOP) Sub-Plan and an Enterprise Management Incentives (EMI) Sub-Plan, allows for the grant of equity and cash-based incentive awards to eligible service providers. The material terms of the F-star EIP are summarized below. References to the F-star EIP include references to the Non-Employee Sub-Plan, the CSOP Sub-Plan and the EMI Sub-Plan, where applicable.
Eligibility and Administration
F-stars employees and executive directors, as well as the employees of its subsidiaries, are eligible to receive awards under the F-star EIP. Consultants and non-employee directors, as well as the consultants of F-stars subsidiaries, are eligible to receive awards under the Non-Employee Sub-Plan. Options may be granted under the EMI Sub-Plan to F-stars U.K. employees who meet the criteria under the EMI regime, which requires, among other things, that they work, on average, at least 25 hours per week or, if less, at least 75% of the employees working time for F-star. Employees who have a material interest in F-star cannot be granted EMI options. A material interest is either beneficial ownership of, or the ability to control directly or indirectly, more than 30% of F-stars ordinary share capital. EMI options can only be granted if F-star meets the criteria under the EMI regime. As of the date hereof, F-star believes it will no longer meet these criteria and does not intend to grant any more EMI options. Options may be granted under the CSOP Sub-Plan to U.K. employees who meet the criteria under the CSOP regime, which requires, among other things, that they do not have a material interest in F-star (as described above in connection with the EMI options). F-star can only grant CSOP options if F-star meets the criteria under the CSOP regime.
The F-star EIP is administered by the F-star Board of Directors, which may delegate its duties and responsibilities to one or more committees of directors and/or officers, which is referred to collectively as the plan administrator below. Subject to the limitations imposed under the F-star EIP, stock exchange rules and other applicable laws, the plan administrator has the authority to take all actions and make all determinations under the F-star EIP, to interpret the F-star EIP and award agreements and to adopt, amend and repeal rules for the administration of the F-star EIP, as it deems advisable. The plan administrator also has the authority to determine which eligible service providers receive awards, grant awards and set the terms and conditions of all awards under the F-star EIP, including any vesting and vesting acceleration provisions, subject to the conditions and limitations in the F-star EIP.
Shares Available for Awards
The aggregate number of F-star ordinary shares that may be issued pursuant to awards under the F-star EIP is shares. The maximum number of shares that may be issued upon the exercise of incentive stock options under the F-star EIP is 2,087,018 shares. If an award granted pursuant to the F-star EIP expires, lapses or is terminated or is exchanged for cash, surrendered, repurchased or canceled without having been fully exercised, any unused shares subject to the award will, as applicable, become or again be available for new grants under the F-star EIP. Options granted under the EMI Sub-Plan are subject to individual and overall limits, as specified by the EMI regime from time to time.
Awards
The F-star EIP provides for the grant of options, share appreciation rights (SARs) restricted shares, restricted share units (RSUs) performance share units (PSUs) and other share based awards. All awards
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under the F-star EIP will be set forth in award agreements, which will detail the terms and conditions of awards, including any applicable vesting and payment terms and post-termination exercise limitations. A brief description of each award type follows.
Options and SARs. Options provide for the purchase of F-star ordinary shares in the future at an exercise price set on the grant date. SARs entitle their holder, upon exercise, to receive from F-star an amount equal to the appreciation of the shares subject to the award between the grant date and the exercise date. The plan administrator will determine the number of shares covered by each option and SAR, the exercise price of each option and SAR and the conditions and limitations applicable to the exercise of each option and SAR.
Restricted Shares, Restricted Share Units and Performance Share Units. Restricted shares are an award of nontransferable ordinary shares that remain forfeitable unless and until specified conditions are met and which may be subject to a purchase price. RSUs are contractual promises to deliver F-star ordinary shares in the future, subject to a time-based vesting schedule. Performance Share Units are contractual promises to deliver F-star ordinary shares in the future, subject to the satisfaction of specified conditions. The plan administrator will determine the terms and conditions applicable to restricted shares, RSUs and PSUs, subject to the conditions and limitations contained in the F-star EIP.
Other Share Based Awards. Other share-based awards are awards of fully-vested ordinary shares and other awards valued wholly or partially by referring to, or otherwise based on, F-star ordinary shares or other property. Other share- or cash-based awards may be granted to participants. The plan administrator will determine the terms and conditions of other share-based awards, which may include any purchase price, performance goal, transfer restrictions and vesting conditions.
Certain Transactions
In connection with a change in control, if awards under the F-star EIP are assumed or substituted for awards covering the equity securities of the successor or survivor corporation, and if the award holders service is terminated without cause in the 12 months following such change in control, such award shall become fully vested and exercisable upon the date of termination of service. In connection with a change in control, if the successor or survivor corporation does not assume or substitute awards under the F-star EIP, all outstanding awards under the F-star EIP other than EMI options and certain CSOP options will become fully vested and exercisable immediately prior to the change in control. EMI options and CSOP options for which the award holder has not accepted a rollover offered in accordance with applicable law will be forfeited.
In connection with certain corporate transactions and events affecting F-stars ordinary shares, other than a change in control, including an unusual or nonrecurring transaction or event affecting F-star or its financial statements or a change in any applicable laws or accounting principles, the plan administrator has broad discretion to take action under the F-star EIP to prevent the dilution or enlargement of intended benefits, facilitate the transaction or event or give effect to the change in applicable laws or accounting principles. This includes canceling awards for cash or property, accelerating the vesting of awards, providing for the assumption or substitution of awards by a successor entity, adjusting the number and type of shares subject to outstanding awards and/or with respect to which awards may be granted under the F-star EIP and replacing or terminating awards under the F-star EIP.
Plan Amendment and Termination
The plan administrator may amend or terminate the F-star EIP at any time; however, no amendment, other than an amendment that increases the number of shares available under the F-star EIP, may materially and adversely affect an award outstanding under the F-star EIP without the consent of the affected participant and shareholder approval will be obtained for any amendment to the extent necessary to comply with applicable laws. The F-star EIP will remain in effect until the tenth anniversary of its effective date unless earlier terminated by the F-star Board of Directors.
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Legacy Schemes
Prior to the corporate reorganization that occurred in May 2019, F-star granted options under certain schemes of its subsidiaries (the Legacy Schemes), which include the F-star Alpha Limited Share Option Scheme, or the Alpha Scheme, the F-star Beta Limited Share Option Scheme, or the Beta Scheme, and the F-star EMI Share Option Scheme, or the GmbH Scheme. Outstanding stock options under the legacy schemes were originally granted with respect to shares of F-star Alpha, F-star Beta and F-star GmbH, respectively. Following the corporate reorganization, on June 14, 2019, outstanding options under the Legacy Schemes were replaced, in accordance with the terms of the applicable Legacy Scheme and applicable law and with participant consent in the case of options qualifying as EMI options under the GmbH Scheme, with options to acquire F-star ordinary shares.
F-star does not intend to grant further options under any of the Legacy Schemes.
The options to acquire F-star ordinary shares that were issued in connection with the Corporate Reorganization and as substitute awards for options granted under the Legacy Schemes are mostly fully vested and exercisable.
Alpha Scheme and Beta Scheme
The Alpha Scheme and the Beta Scheme (collectively the AB Schemes) were amended by resolutions of the boards of directors of F-star Alpha and F-star Beta on March 6, 2019. The AB Schemes allow for the grant of options to eligible employees. The material terms of the Alpha Scheme and the Beta Scheme are substantially the same and are summarized below.
Eligibility and Administration
Employees of F-star GmbH and its subsidiaries, which previously included F-star Alpha and F-star Beta, are eligible to be granted options under the AB Schemes. The AB Schemes are administered by the relevant companys board of directors, which may delegate its duties and responsibilities to a duly authorized committee of the board of directors, which F-star refers to collectively as the plan administrator. The plan administrator has the authority to take all actions and make all determinations under the AB Schemes and to finally resolve any dispute or question related to any option granted under the AB Schemes as it deems advisable. The plan administrator also has the authority to determine which eligible employees are granted options, to grant options and to set the vesting schedules applicable to all options under the AB Schemes, subject to the conditions and limitations in the AB Schemes.
Awards
The AB Schemes provide for the grant of options. All options granted under the AB Schemes will be set forth in option agreements, which will detail the date of grant of the option, the number of shares which may be acquired upon exercise of the options, the option exercise price (or method by which it shall be determined), and the applicable vesting schedule.
Options provide for the purchase of ordinary shares, which were originally ordinary shares of F-star Alpha or F-star Beta, as applicable, and are now F-star ordinary shares, in the future at an exercise price set on the grant date. The plan administrator will determine the number of shares covered by each option, the exercise price of each option and the vesting schedule applicable to each option.
Performance Criteria
The vesting of options is not subject to any performance criteria. Options may not be exercised until they have vested and an exit, as defined in the applicable AB Scheme, has occurred, and options may not be exercised more than 10 years after the applicable date of grant.
Certain Transactions
Options granted under the AB Schemes will become exercisable in full in connection with certain corporate transactions and events affecting F-star ordinary shares.
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In addition, in the event of certain non-reciprocal transactions with F-star shareholders, the plan administrator will make such adjustments to the exercise price and number of shares subject to outstanding options as it may determine with the intention that, as nearly as may be, the total exercise price multiplied by the number of shares under option shall remain unchanged.
Plan Amendment and Termination
The plan administrator may amend or terminate the AB Schemes at any time and may impose additional conditions or requirements on the options or on the terms on which shares are acquired; however, no amendment, may abrogate or adversely affect the subsisting rights of option holders unless: (i) with respect to an amendment impacting an individual option holder, that option holder consents in writing, or (ii) with respect to an amendment affecting all option holders or a class thereof, either (a) option holders holding at least 75 percent of the affected shares issuable upon exercise of outstanding options consent in writing; or (b) at least 75 percent of the affected option holders present at a meeting of affected option holders so resolve. The AB Schemes will remain in effect until the tenth anniversary of their adoption unless earlier terminated by the F-star Board of Directors.
GmbH Scheme
The GmbH Scheme was amended by resolution of the board of directors of F-star GmbH on March 6, 2019. The GmbH Scheme allows for the grant of options or EMI options to eligible employees.
The rules of the GmbH Scheme are substantially the same as the rules of the Alpha Scheme and the Beta Scheme, except as described below.
Eligibility and Administration
Employees of F-star GmbH and its subsidiaries are eligible to be granted options under the GmbH Scheme. EMI options may be granted to employees who meet the criteria under the EMI regime, which requires, among other things, that they work, on average, at least 25 hours per week or, if less, at least 75% of the employees working time for F-star GmbH and its subsidiaries. Employees who have a material interest in F-star GmbH or the applicable subsidiary cannot be granted EMI options. A material interest is either beneficial ownership of, or the ability to control directly or indirectly, more than 30% of the applicable companys ordinary share capital.
Certain Transactions
Options issued under the GmbH Scheme will become exercisable in full in connection with certain corporate transactions and events affecting F-star ordinary shares.
Plan Amendment and Termination
The plan administrator may not amend the GmbH Scheme in a way that would have the effect of causing EMI options to cease to be EMI options. The plan administrator may make such amendments or additions to the GmbH Scheme as may be necessary to ensure compliance with the EMI regime.
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RELATED PARTY TRANSACTIONS OF DIRECTORS AND
EXECUTIVE OFFICERS OF THE COMBINED COMPANY
Described below are any transactions occurring since January 1, 2017 and any currently proposed transactions to which either Spring Bank or F-star was a party and in which:
|
the amounts involved exceeded or will exceed $120,000; and |
|
a director, executive officer, holder of more than 5% of the outstanding capital stock of Spring Bank or F-star, or any member of such persons immediate family, had or will have a direct or indirect material interest. |
Spring Bank Transactions
Except as set forth herein and in the section titled The ExchangeInterests of the Spring Bank Directors and Executive Officers in the Exchange, there were no transactions to which Spring Bank was a party from January 1, 2018 through the date of this proxy statement/prospectus with Spring Banks directors and officers and beneficial owners of more than 5% of Spring Banks voting securities and their affiliates.
Underwritten Public Offering
In June 2017, Spring Bank completed a public offering of 3,269,219 shares of its common stock at $13.00 per share. Kurt Eichler, a member of the Spring Bank Board, purchased 76,923 shares of Spring Bank common stock at the public offering price of $13.00 per share. Additionally, UBS Oncology Impact Fund L.P. (Oncology Impact Fund), purchased 230,769 shares of Spring Bank common stock at the public offering price of $13.00 per share. Oncology Impact Fund was a holder of more than 5% of Spring Banks then issued and outstanding voting securities at the time of the transaction.
Indemnification
Spring Banks amended and restated certificate of incorporation, as amended, provides that Spring Bank will indemnify its directors and officers to the fullest extent permitted by Delaware law. In addition, Spring Bank has entered into indemnification agreements with each of its directors and executive officers. Each of these indemnification agreements provides, among other things, that Spring Bank will indemnify such director or executive officer to the fullest extent permitted by law for claims arising in his or her capacity as a director or officer, as applicable, provided that he or she acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, Spring Banks best interests and, with respect to any criminal proceeding, had no reasonable cause to believe that his or her conduct was unlawful. Each of these indemnification agreements provides that in the event that Spring Bank does not assume the defense of a claim against a director or officer, as applicable, Spring Bank will be required to advance his or her expenses in connection with his or her defense, provided that he or she undertakes to repay all amounts advanced if it is ultimately determined that he or she is not entitled to be indemnified by Spring Bank.
Policies and Procedures for Related Party Transactions
Spring Banks Board of Directors has adopted written policies and procedures in compliance with Item 404 of Regulation S-K for the review of any transaction, arrangement or relationship in which it is a participant, the amount involved exceeds $120,000 and one of Spring Banks executive officers, directors, director nominees or 5% stockholders, or their immediate family members, each of whom are referred to as a related person has a direct or indirect material interest.
If a related person proposes to enter into such a transaction, arrangement or relationship, which is referred to as a related person transaction, the related person must report the proposed related person transaction to Spring Banks chief financial officer. The policy calls for the proposed related person transaction to be reviewed and approved by the Audit Committee. Whenever practicable, the reporting, review and approval will occur prior to entry into the transaction. If advance review and approval is not practicable, the committee will review, and, in its discretion, may ratify the related person transaction. The policy also permits the Chairman of the Audit Committee to review and, if deemed appropriate, approve proposed related person transactions that arise between
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committee meetings, subject to ratification by the committee at its next meeting. Any related person transactions that are ongoing in nature will be reviewed annually.
A related person transaction reviewed under the policy will be considered approved or ratified if the Audit Committee authorizes it after full disclosure of the related persons interest in the transaction. As appropriate for the circumstances, the committee will review and consider:
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the related persons interest in the related person transaction; |
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the approximate dollar value of the amount involved in the related person transaction; |
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the approximate dollar value of the amount of the related persons interest in the transaction without regard to the amount of any profit or loss; |
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whether the transaction was undertaken in the ordinary course of Spring Banks business; |
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whether the terms of the transaction are no less favorable to Spring Bank than terms that could have been reached with an unrelated third party; |
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the purpose of, and the potential benefits to Spring Bank of, the transaction; and |
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any other information regarding the related person transaction or the related person in the context of the proposed transaction that would be material to investors in light of the circumstances of the particular transaction. |
The Audit Committee may approve or ratify the transaction only if the committee determines that, under all of the circumstances, the transaction is in Spring Banks best interests. The committee may impose any conditions on the related person transaction that it deems appropriate. The policy provides that transactions involving compensation of executive officers will be reviewed and approved by the Compensation Committee in the manner specified in its charter.
F-star Transactions
Except as set forth herein, there were no transactions to which F-star was a party from January 1, 2017 through the date of this proxy statement/prospectus with F-stars directors and officers and beneficial owners of more than 5% of F-stars voting securities and their affiliates. The F-star transactions described in this section were entered into prior to the adoption of a related party transaction policy. Although F-star has not had a written policy for the review and approval of transactions with related persons, its Board of Directors has historically and routinely reviewed and approved any transaction where a director or officer had a financial interest, including the transactions described below. Prior to approving such a transaction, the material facts as to a directors or officers relationship or interest in the agreement or transaction, if any, were disclosed to F-stars Board of Directors. The F-star Board of Directors took this information into account when evaluating the transaction and in determining whether such transaction was fair to F-star and in the best interest of all its shareholders.
F-star believes the terms obtained or consideration that it paid or received, as applicable, in connection with the transactions described below were comparable to terms available or the amounts that would be paid or received, as applicable, in arms-length transactions.
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Affiliations with 5% Shareholders
Some of F-stars directors are affiliated with its principal shareholders as indicated in the table below:
Director |
Affiliation with Principal Shareholder |
|
Nessan Bermingham, Ph.D. | Venture Partner at Atlas Venture, an affiliate of a principal shareholder of F-star | |
Jean-Francois Formela, M.D. | Partner at Atlas Venture, an affiliate of a principal shareholder of F-star | |
Deborah Harland, Ph.D. | Partner at S.R. One, a principal shareholder of F-star | |
Patrick Krol | Managing Partner of Aescap Venture, an affiliate of a principal shareholder of F-star | |
Helmut Schuehsler, Ph.D. | Chairman of TVM Capital Group and Chief Executive Officer of TVM Capital Healthcare Partners, affiliates of principal shareholders of F-star |
Purchases from Avacta Life Sciences Limited
During the fiscal year ended December 31, 2019, F-star made purchases totaling £120,000 (2018: £nil) from Avacta Life Sciences Limited, a company in which one of F-stars directors Eliot Forster also holds a directorship. As at December 31, 2019, the amounts outstanding and included in trade and other payables was £60,000 (2018: £nil).
2019 Corporate Reorganization and Shareholder Agreement
In May 2019, F-star completed a corporate reorganization pursuant to which F-star Therapeutics Limited became the direct holding company of each of F-star Alpha Limited (F-star Alpha), F-star Beta Limited (F-star Beta), F-star Delta Limited (F-star Delta) and f-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H (F-star GmbH) and the indirect holding company of each of F-star Biotechnology Limited (F-star Biotech) and F-star Therapeutics LLC (F-star LLC). Pursuant to the corporate reorganization, (i) the shareholders of F-star Delta, including the holders of more than 5% of F-stars outstanding voting securities and their affiliates, exchanged each of the shares held by them in F-star Delta for the same number and class of newly issued shares in F-star Therapeutics Limited and (ii) the shareholders of each of F-star Alpha, F-star Beta and F-star GmbH, including the holders of more than 5% of its outstanding voting securities and their affiliates, exchanged each of the shares (or share quotas, in the case of F-star GmbH) held by them in F-star Alpha, F-star Beta and F-star GmbH for newly issued shares in F-star Therapeutics Limited.
In connection with F-stars corporate reorganization, F-star entered into a shareholder agreement containing certain information rights, among other things, with certain shareholders of F-star including Eliot Forster, F-stars Chief Executive Officer and director, Neil Brewis, F-stars Chief Scientific Officer, Florian Rucker, former director of F-star, Tolga Hassan, F-stars former Chief Financial Officer and Chief Operating Officer, and shareholders affiliated with certain of F-stars directors or greater than 5% shareholders including entities affiliated with Atlas Venture Fund, Aescap Venture, TVM Life Sciences, MP Healthcare Venture Management, Inc., Merck Ventures BV and S.R. One, Limited. The shareholder agreement will terminate upon the Closing.
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Convertible Note Financing
In September and November 2019, and March and July 2020, F-star issued convertible loan notes for an aggregate principal amount of approximately $14.9 million. The convertible notes accrue interest at 8.0%, compounded annually. There will be approximately $1.0 million of accrued interest as of October 15, 2020. All outstanding principal and interest under these convertible notes will convert into ordinary shares of F-star immediately prior to the Exchange, which will then be exchanged for shares of Spring Bank common stock at the Closing. The table below sets forth the principal amount of the convertible loan notes sold to entities affiliated with F-stars former Chief Executive Officer John Haurum, and to holders of more than 5% of F-stars share capital, or an affiliate thereof, certain of which are affiliated with F-star directors.
Purchasers |
Aggregate Principal
Price |
|||
Atlas Venture Opportunity Fund I, LP (1) |
$ | 4,000,000 | ||
Coöperatieve AESCAP Venture I U.A. (2) |
$ | 1,000,000 | ||
TVM Life Sciences Ventures VI GmbH & Co. (3) |
$ | 990,000 | ||
TVM Life Sciences Ventures VI Limited Partnership (3) |
$ | 274,000 | ||
MP Healthcare Venture Management, Inc. |
$ | 1,000,000 | ||
Merck Ventures BV |
$ | 2,000,000 | ||
S.R. One, Limited (5) |
$ | 4,000,000 | ||
Entities Affiliated with John Haurum, F-stars former Chief Executive Officer |
$ | 351,074 |
(1) |
Nessan Bermingham, Ph.D., a Venture Partner of Atlas Venture, is a member of F-stars Board of Directors. Jean-Francois Formela, M.D., a partner of Atlas Venture, is a member of F-stars Board of Directors. |
(2) |
Patrick Krol, a Managing Partner at Coöperatieve Aescap Venture I, U.A., is a member of F-stars Board of Directors. |
(3) |
Helmut Schuehsler, Ph.D., an officer of TVM Life Science Ventures Management VI L.P. affiliates of principal shareholders of F-star, is a member of F-stars Board of Directors. |
(4) |
Deborah Harland, Ph.D., a partner at S.R. One Limited, is a member of F-stars Board of Directors. |
Participation in the Pre-Closing Financing
Holders of more than 5% of F-stars share capital, or an affiliate thereof, certain of which are affiliated with F-star directors, have signed equity commitment letters pursuant to which such holders have agreed to enter into a subscription agreement to purchase F-star ordinary shares prior to the Closing in the amounts indicated in the table below at a price per ordinary share of $1.49. The F-star ordinary shares purchased in the Pre-Closing Financing will be exchanged for shares of Spring Bank common stock at the Closing.
Purchasers |
Aggregate Principal
Price |
|||
Atlas Venture Opportunity Fund I, LP (1) |
$ | 2,500,000 | ||
Coöperatieve AESCAP Venture I U.A.(2) |
$ | 1,266,000 | ||
MP Healthcare Venture Management, Inc. |
$ | 1,500,000 | ||
Merck Ventures BV |
$ | 2,000,000 | ||
S.R. One, Limited (3) |
$ | 2,500,000 |
(1) |
Nessan Bermingham, Ph.D., a Venture Partner of Atlas Venture, is a member of F-stars Board of Directors. Jean-Francois Formela, M.D., a partner of Atlas Venture, is a member of F-stars Board of Directors. |
(2) |
Patrick Krol, a Managing Partner at Coöperatieve Aescap Venture I, U.A., is a member of F-stars Board of Directors. |
(3) |
Deborah Harland, Ph.D., a partner at S.R. One Limited, is a member of F-stars Board of Directors. |
License and Collaboration Agreement with Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany
F-star entered into a license and collaboration agreement with Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany in May 2019 (the Ares Agreement). Merck Ventures B.V. is a beneficial owner of more than 5% F-stars outstanding ordinary shares. Under the Ares Agreement, F-star received reimbursement of
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F-stars internal and external development costs for each preclinical program, conducted certain mutually agreed upon preclinical development activities, and delivered data packages to Ares. Following receipt of each data package, Ares had the option to continue with the program, and if Ares elected to continue with the program, Ares would be solely responsible for the continued development, manufacture and commercialization of the applicable licensed products. Ares exercised its option in relation to one of the preclinical programs (the First Program) in May 2019, and exercised its option in relation to the second Program in July 2020. During the term of the Ares Agreement, F-star is subject to certain non-compete obligations. See F-star BusinessCollaboration and License Agreements for additional information regarding the Ares Agreement.
Exercise of Denalis Option to Buy F-star Gamma
In August 2016, F-star Biotechnology Limited, F-star Gamma Limited (F-star Gamma) and F-star Biotechnologische Forchungs-und Entwicklungsges.m.b.H entered into a license and collaboration agreement, or the Denali License and Collaboration Agreement, with Denali Therapeutics Inc. (Denali). In connection with the entry into the collaboration agreement, Denali also purchased from the F-star Gamma shareholders an option, which F-star refers to as the buy-out-option, to acquire all of the outstanding shares of F-star Gamma pursuant to a pre-negotiated share purchase agreement. On May 30, 2018, Denali exercised the buy-out option and entered into a Share Purchase Agreement (the Purchase Agreement) with the shareholders of F-star Gamma and Shareholder Representative Services LLC, pursuant to which Denali acquired all of the outstanding shares of F-star Gamma (the Gamma Acquisition). As a result of the Gamma Acquisition, F-star Gamma became a wholly owned subsidiary of Denali and Denali changed the entitys name to Denali BBB Holding Limited. Denali made initial exercise payments to it and the former shareholders of F-star Gamma under the Purchase Agreement and the F-star Gamma License in the aggregate amount of $18.0 million, less the net liabilities of F-star Gamma, which were approximately $0.2 million. Of this total, $3.6 million was payable to F-star.
In connection with Denalis exercise of this buy-out option and entry into the Purchase Agreement with the shareholders of F-star Gamma and Shareholder Representative Services, certain of F-stars executive officers, former executive officers, directors and greater than 5% shareholders were shareholders of F-star Gamma prior to the Acquisition by Denali and received payments as noted in the table below in connection with Denalis purchase of the buy-out option and with Denalis exercise of the buy-out option. Denali is required to make future contingent payments to these former shareholders of F-star Gamma upon the achievement of certain defined preclinical, clinical, regulatory and commercial milestones. See F-star BusinessCollaboration and License Agreements2016 License and Collaboration Agreement with Denali Therapeutics Inc. for additional information regarding the Acquisition.
F-star Gamma Shareholder |
Payment Associated
with Purchase of the Buy-Out Option |
Payment Associated
with Exercise of Buy-Out Option |
||||||
Atlas Venture Fund VII, L.P.(1) |
$ | 148,000 | $ | 4,123,605 | ||||
Coöperatieve AESCAP Venture I U.A.(2) |
$ | 107,450 | $ | 2,993,144 | ||||
TVM Life Science Ventures VI GmbH & Co.(3) |
$ | 46,400 | $ | 1,292,375 | ||||
TVM Life Science Ventures VI Limited Partnership(3) |
$ | 12,850 | $ | 358,290 | ||||
S.R. One Limited(4) |
$ | 52,600 | $ | 1,465,867 | ||||
MP Healthcare Venture Management, Inc. |
$ | 35,600 | $ | 991,730 | ||||
Merck Ventures B.V. |
$ | 35,350 | $ | 984,802 | ||||
John Haurum(5) |
$ | 23,250 | $ | 647,923 | ||||
Neil Brewis |
$ | 6,450 | $ | 179,979 | ||||
Jane Dancer(5) |
$ | 6,450 | $ | 179,979 | ||||
John Edwards(6) |
$ | 6,450 | $ | 179,979 | ||||
Tolga Hassan(5) |
$ | 6,450 | $ | 179,979 |
(1) |
Nessan Bermingham, Ph.D., a Venture Partner of Atlas Venture, is a member of F-stars Board of Directors. Jean-Francois Formela, M.D., a partner of Atlas Venture, is a member of F-stars Board of Directors. |
(2) |
Patrick Krol, a Managing Partner at Coöperatieve Aescap Venture I, U.A., is a member of F-stars Board of Directors. |
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(3) |
Helmut Schuehsler, Ph.D., an officer of TVM Life Science Ventures Management VI L.P. affiliates of principal shareholders of F-star, is a member of F-stars Board of Directors. |
(4) |
Deborah Harland, Ph.D., a partner at S.R. One Limited, is a member of F-stars Board of Directors. |
(5) |
Former officer of F-star. |
(6) |
Former director of F-star. |
F-star Delta Option Agreement
F-star Delta was previously party to an Option Agreement dated June 4, 2017, between Merck, F-star Delta, the shareholders of F-star Delta, and Shareholder Representative Services LLC, which Option Agreement was terminated on May 13, 2019. F-stars certain of F-stars executive officers, former executive officers, directors and greater than 5% shareholders received the payments shown in the table below in connection with Merck Sharp & Dohmes purchase of the option to acquire F-star Delta. No future payments are due to any current or former shareholders of F-star Delta.
F-star Delta Shareholder |
Payment Associated
with Purchase of the Buy-Out Option |
|||
Atlas Venture Fund VII, L.P.(1) |
$ | 13,653,817 | ||
Coöperatieve AESCAP Venture I U.A.(2) |
$ | 9,907,793 | ||
TVM Life Science Ventures VI GmbH & Co.(3) |
$ | 4,277,211 | ||
TVM Life Science Ventures VI Limited Partnership(3) |
$ | 1,187,087 | ||
S.R. One Limited(4) |
$ | 4,854,588 | ||
MP Healthcare Venture Management, Inc. |
$ | 3,284,122 | ||
Merck Ventures B.V. |
$ | 3,261,027 | ||
John Haurum(5) |
$ | 2,120,129 | ||
Neil Brewis |
$ | 572,758 | ||
Jane Dancer(5) |
$ | 572,758 | ||
John Edwards(6) |
$ | 1,122,422 | ||
Tolga Hassan(5) |
$ | 572,758 |
(1) |
Nessan Bermingham, Ph.D., a Venture Partner of Atlas Venture, is a member of F-stars Board of Directors. Jean-Francois Formela, M.D., a partner of Atlas Venture, is a member of F-stars Board of Directors. |
(2) |
Patrick Krol, a Managing Partner at Coöperatieve Aescap Venture I, U.A., is a member of F-stars Board of Directors. |
(3) |
Helmut Schuehsler, Ph.D., an officer of TVM Life Science Ventures Management VI L.P. affiliates of principal shareholders of F-star, is a member of F-stars Board of Directors. |
(4) |
Deborah Harland, Ph.D., a partner at S.R. One Limited, is a member of F-stars Board of Directors. |
(5) |
Former officer of F-star. |
(6) |
Former director of F-star. |
Employment Arrangements
F-star has entered into employment agreements, consulting agreements or offer letter agreements with certain of its executive officers and service agreements with certain of its non-executive directors. The agreements with executive officers contain customary provisions and representations, including confidentiality, non-competition, non-solicitation and inventions assignment undertakings by the executive officers. However, the enforceability of the non-competition provisions may be limited under applicable law. For more information regarding these agreements with F-stars named executive officers, see F-star Executive CompensationEmployment arrangements.
Stock option and restricted stock unit grants to directors and executive officers
F-star has granted stock options to certain of its directors and executive officers. For more information regarding the stock options and RSUs granted to F-stars directors and named executive officers, see F-star
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Executive CompensationEquity Incentive Plans and The ExchangeInterests of the F-star Directors and Executive Officers in the Exchange.
Separation pay agreements
F-star has entered into separation pay agreements with certain of its executive officers. For more information regarding these arrangements with F-stars named executive officers, see F-star Executive CompensationPotential Payments Upon Termination or Change of Control.
Indemnification Agreements
F-star intends to enter into a deed of indemnity with each of its directors and executive officers prior to the Closing. F-stars certificate of incorporation and bylaws to be effective upon completion of the Share Exchange will also provide that F-star will indemnify its directors and executive officers to the fullest extent permitted by law. See F-star ManagementInsurance and Indemnification for further information.
Combined Company Related Party Transaction Policy
The F-star Board of Directors will adopt written policies and procedures for the review of any transaction, arrangement or relationship in which F-star was, is or will be a participant and one of F-stars executive officers, directors, director nominees or 5% stockholders (or their immediate family members), each of whom F-star refers to as a related person, has a direct or indirect material interest.
If a related person proposes to enter into such a transaction, arrangement or relationship, a related person transaction, the policy calls for the proposed related person transaction to be reviewed and, if deemed appropriate, approved by the Audit Committee of the F-star Board of Directors. Whenever practicable, the reporting, review and approval will occur prior to entry into the transaction. If advance review and approval is not practicable, the committee will review, and, in its discretion, may ratify the related person transaction.
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Description of Capital Stock
Spring Bank is authorized to issue 210,000,000 shares of capital stock, including 200,000,000 shares of common stock, par value $0.0001 per share and 10,000,000 undesignated shares of preferred stock, par value $0.0001 per share. As of September 15, 2020, Spring Bank had no shares of preferred stock outstanding and 17,248,545 shares of common stock outstanding with approximately 71 stockholders of record.
The following description of Spring Banks capital stock is not complete and may not contain all the information you should consider before investing in Spring Banks capital stock. This description is summarized from, and qualified in its entirety by reference to, Spring Banks amended and restated certificate of incorporation and amended and restated bylaws, which have been publicly filed with the SEC. See Where You Can Find More Information.
General
The holders of common stock are entitled to one vote per share on all matters submitted to a vote of Spring Bank stockholders and do not have cumulative voting rights. An election of directors by Spring Bank stockholders will be determined by a plurality of the votes cast by the stockholders entitled to vote on the election. Other matters will be decided by the affirmative vote of Spring Bank stockholders having a majority in voting power of the votes cast by the stockholders present or represented and voting on such matter, except as otherwise disclosed below. Spring Banks bylaws provide that the holders of a majority of the outstanding shares of Spring Bank common stock represent a quorum for the transaction of business at stockholder meetings, except where a separate vote by a class of capital stock is required, the holders of a majority in voting power of such class, if present by remote communication or by proxy, represent a quorum for such matter. Subject to preferences that may be applicable to any preferred stock outstanding at the time, the holders of outstanding shares of common stock are entitled to receive ratably any dividends declared by Spring Bank Board. In the event of Spring Banks liquidation, dissolution or winding up, holders of Spring Bank common stock are entitled to share ratably in all assets remaining after payment of liabilities and the liquidation preference of any then-outstanding shares of preferred stock. Holders of Spring Bank common stock do not have preemptive or conversion rights, or other subscription rights. There are no redemption provisions applicable to Spring Banks common stock.
Transfer Agent and Registrar
The transfer agent and registrar for Spring Banks common stock is Computershare Trust Company, N.A., with offices at 150 Royall Street, Canton, MA 02021.
Stock Exchange Listing
Spring Banks common stock is listed for quotation on the Nasdaq Capital Market under the symbol SBPH.
Anti-Takeover Provisions
Delaware Law
Section 203 of the DGCL prevents some Delaware corporations from engaging, under some circumstances, in a business combination, which includes a merger or sale of at least 10% of the corporations assets with any interested stockholder, meaning a stockholder who, together with affiliates and associates, owns or, within three years prior to the determination of interested stockholder status, did own 15% or more of the corporations outstanding voting stock, unless:
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the transaction is approved by the board of directors prior to the time that the interested stockholder became an interested stockholder; |
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upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced; or |
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at or subsequent to such time that the stockholder became an interested stockholder the business combination is approved by the board of directors and authorized at an annual or Special Meeting of stockholders by at least two-thirds of the outstanding voting stock that is not owned by the interested stockholder. |
If Section 203 applied to Spring Bank, the restrictions could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, could discourage attempts to acquire Spring Bank.
Amended and Restated Certificate of Incorporation and Restated Bylaw Provisions
Spring Banks amended and restated certificate of incorporation and Spring Banks restated bylaws include a number of provisions that may have the effect of deterring hostile takeovers or delaying or preventing changes in control of Spring Banks management team, including the following:
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Board of Directors Vacancies. Spring Banks amended and restated certificate of incorporation and restated bylaws authorize only Spring Banks Board of Directors to fill vacant directorships. In addition, the number of directors constituting the full Board of Directors will not be changed without the affirmative vote of the Board of Directors. These provisions hinder a stockholder from increasing the size of Spring Banks Board of Directors and gaining control of the Board of Directors by filling the resulting vacancies with its own nominees. |
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Classified Board. Spring Banks amended and restated certificate of incorporation and proposed restated bylaws provide that its Board of Directors is classified into three classes of directors. The existence of a classified board could delay a successful tender offeror from obtaining majority control of its Board of Directors, and the prospect of that delay might deter a potential offeror. Pursuant to the amended and restated certificate of incorporation, Spring Banks directors may be removed by the stockholders only for cause by the affirmative vote of at least sixty-six and two thirds percent (66 2/3%) of the votes that all stockholders would be entitled to cast in an election of directors. In addition, stockholders will not be permitted to cumulate their votes for the election of directors. |
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Stockholder Action; Special Meeting of Stockholders. Spring Banks amended and restated certificate of incorporation provides that Spring Banks stockholders may not take action by written consent, but may only take action at annual or Special Meetings of its stockholders. Spring Banks amended and restated certificate of incorporation further provides that Special Meetings of its stockholders may be called only by a majority of the Board of Directors, the chairman of the Board of Directors and the chief executive officer, or upon the request of the holders of a majority of the issued and outstanding common stock. |
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Advance Notice Requirements for Stockholder Proposals and Director Nominations. Spring Banks restated bylaws provide advance notice procedures for stockholders seeking to bring business before the annual meeting of stockholders, or to nominate candidates for election as directors at the annual meeting of stockholders. Spring Banks restated bylaws also specify certain requirements regarding the form and content of a stockholders notice. These provisions may preclude its stockholders from bringing matters before the annual meeting of stockholders or from making nominations for directors at the annual meeting of stockholders. |
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Issuance of Undesignated Preferred Stock. Under Spring Banks amended and restated certificate of incorporation, its Board of Directors has the authority, without further action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock with rights and preferences, including voting rights, designated from time to time by the Board of Directors. The existence of authorized but unissued shares of preferred stock enables the Board of Directors to render more difficult or to discourage an attempt to obtain control of Spring Bank by means of a merger, tender offer, proxy contest or otherwise. |
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Exclusive Forum. Spring Banks amended and restated certificate of incorporation specifies that, unless Spring Bank consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for: (i) any derivative action or proceeding brought on behalf of the corporation; (ii) any action asserting a claim of breach of a |
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fiduciary duty owed by any director, officer or other employee of the corporation to the corporation or the corporations stockholders; (iii) any action asserting a claim arising pursuant to any provision of the DGCL; and (iv) any action asserting a claim governed by the internal affairs doctrine. This exclusive forum provision does not apply to suits brought to enforce a duty or liability created by the Exchange Act. Further, Spring Banks amended and restated bylaws provide that, unless Spring Bank consents in writing to an alternative forum, the U.S. federal district courts will have exclusive jurisdiction for any complaint asserting a cause of action under the Securities Act. However, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. There is uncertainty as to whether a court would enforce this provision with respect to claims under the Securities Act, and Spring Banks stockholders cannot waive its compliance with the federal securities laws and the rules and regulations thereunder. Spring Bank believes these provisions provide increased consistency in the application of Delaware law by chancellors particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. However, these provisions may have the effect of discouraging lawsuits against Spring Banks directors and officers. The enforceability of similar choice of forum provisions in other companies certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against Spring Bank, a court could find the choice of forum provisions contained in Spring Banks amended and restated certificate of incorporation or amended and restated bylaws to be inapplicable or unenforceable in such action. |
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COMPARISON OF RIGHTS OF HOLDERS OF SPRING BANK STOCK AND F-STAR SHARE CAPITAL
Spring Bank is incorporated under the laws of the State of Delaware and, accordingly, the rights of the stockholders of Spring Bank are currently, and will continue to be, governed by the DGCL. F-star is registered in England and Wales and the rights of F-star shareholders are currently governed by the Companies Act 2006 (the Companies Act), F-stars articles of association and the shareholders agreement between F-star and its shareholders. After the Closing, shareholders of F-star will become stockholders of Spring Bank, and their rights will be governed by the DGCL, the certificate of incorporation and the bylaws of F-star.
The table below summarizes the material differences between the current rights of F-star shareholders under the F-star articles of association and the rights of Spring Bank stockholders, following the Exchange, under the Spring Bank amended and restated certificate of incorporation and bylaws, as amended, as applicable, and as in effect immediately following the Exchange.
While Spring Bank and F-star believe that the summary tables cover the material differences between the rights of their respective stockholders and shareholders prior to the Exchange and the rights of Spring Bank stockholders following the Exchange, these summary tables may not contain all of the information that is important to you. These summaries are not intended to be a complete discussion of the respective rights of Spring Bank stockholders and F-star shareholders, and are qualified in their entirety by reference to the DGCL, the Companies Act and the various documents of Spring Bank and F-star that are referred to in the summaries. You should carefully read this entire proxy statement/prospectus and the other documents referred to in this proxy statement/prospectus for a more complete understanding of the differences between being a stockholder of Spring Bank or a shareholder of F-star before the Exchange and being a stockholder of Spring Bank after the Exchange. Spring Bank has filed copies of its current amended and restated certificate of incorporation and bylaws with the SEC and will send copies of the documents referred to in this proxy statement/prospectus to you upon your request. See the section titled Where You Can Find More Information in this proxy statement/prospectus.
Current F-star Rights Versus Rights Post-Exchange
Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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Authorized Capital Stock | As of September 15, 2020, the issued share capital of F-star consists of (i) 16,265,864 ordinary shares of, par value £0.01 per share, (ii) 103,611 Seed Preference Shares, par value £0.01 per share, and (iii) 1,441,418 Series A Preference Shares, par value £0.01 per share. | The amended and restated certificate of incorporation of Spring Bank authorizes the issuance of up to 200,000,000 shares of common stock, par value $0.0001 per share and 10,000,000 shares of undesignated preferred stock, par value $0.0001 per share. | ||
Number of Directors | F-stars articles of association provide that unless agreed otherwise by certain holders of ordinary shares, Seed Preference Shares and Series A Shares, the number of directors must not be more than nine and must not be less than three. | Spring Banks amended and restated certificate of incorporation and amended and restated bylaws do not provide for a maximum or minimum number of directors. The number of directors must be set by approval of the Board of Directors. Currently the size of the Board of Directors is fixed at seven (7). | ||
Stockholder Nominations and Proposals | F-stars articles of association provide certain shareholders with rights to appoint and remove directors. | Spring Banks amended and restated bylaws provide that a stockholder entitled to vote at the annual meeting of the |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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So long as each Investor holds not less than 7.5% of the issued shares comprised in F-stars share capital, other than deferred shares (the Equity Shares), it has the right to appoint (and remove or replace ) a director.
Each of the directors appointed by an Investor is entitled to be appointed to any committee of the F-star Board of Directors and to the board of directors of any of F-stars subsidiaries.
TVM Life Science Ventures VI GmbH & Co. KG and TVM Life Science Ventures VI Limited Partnership; Atlas Venture Fund VII, LP; Coöperative AESCAP Venture I U.A.; MP Healthcare Venture Management, Inc.; Merck Ventures BV and Merck Holding GmbH; Novo A/S; and S.R. One, Limited; and each of their permitted transferees (the Investors) jointly, acting by the prior written consent of the Qualified Majority (the Qualified Majority Consent), may appoint (and remove or replace) up to: (i) two independent directors to the F-star Board of Directors, one of whom shall act as the F-star Board of Directors chairman; and (ii) one director as the F-stars Chief Executive Officer.
F-stars shareholders agreement provides that if an Investor between 3.5% and 7.5% of the issued Equity Shares, that Investor shall have the right to appoint a an observer who may attend each meeting of the F-star Board of Directors, any committee of the F-star Board of Directors and any meeting of the board of directors of any of F-stars subsidiaries.
Certain of F-stars investors also have an entrenched right to appoint an observer to attend each and any meeting of the F-star Board of Directors, any committee of the F-star Board of Directors and any meeting of the board of directors of any of F-stars subsidiaries. |
stockholders may nominate persons for election to the Board of Directors or propose business to be considered by the stockholders at such annual meeting, subject to certain notice and procedural requirements. |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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Classified Board of Directors | F-stars articles of association do not provide for the division of the F-star Board of Directors into staggered classes. | Spring Banks amended and restated certificate of incorporation provides for the Board of Directors to be divided into three classes, with one class being elected each year at the annual meeting and members of each class holding office for a three-year term. | ||
Removal of Directors |
Under the Companies Act, the F-star Board of Directors has the power to call a general meeting of F-stars shareholders and F-stars shareholders have a right to require that the directors exercise this power.
F-stars articles of association provide that if the shareholders exercise such sower, the F-star Board of Directors must convene the meeting for a date not later than 28 days after the date on which they became subject to the requirement under the Companies Act. |
Under the amended and restated certificate of incorporation of Spring Bank, a director may be removed from office at any time, but only for cause and only by the affirmative vote of the holders of 66 2/3% of the voting power of all then outstanding shares of voting stock of Spring Bank with the power to vote at an annual election of directors. | ||
Special Meeting of the Stockholders | Under the Companies Act 2006, F-stars Board has the power to call a general meeting of the shareholders of F-star. In addition, F-stars shareholders have a right to require that the directors exercise their power and call a general meeting. F-stars articles of association provide that if the shareholders exercise such power F-stars Board must convene the meeting for a date not later than 28 days after the date on which they became subject to such requirement under the Companies Act. | The amended and restated certificate of incorporation of Spring Bank and the amended and restated bylaws of Spring Bank provide that a Special Meeting of the stockholders of Spring Bank may be called, for any purpose or purposes, at any time by the Spring Bank Board, the Chairman of the Board or the Chief Executive Officer, but such Special Meetings may not be called by stockholders or any other person or persons. | ||
Cumulative Voting | F-stars articles of association do not have a provision granting cumulative voting rights in the election of its directors. | The DGCL does not provide Spring Banks stockholders with the right to cumulate their votes in the election of directors. | ||
Vacancies | With the exception of the nomination procedures discussed above, F-stars articles of association do not provide specific procedures for filling a vacancy on the F-star Board. | The amended and restated certificate of incorporation and amended and restated bylaws of Spring Bank provide that, subject to the rights of holders of any series of preferred stock, any vacancy or newly created directorships on the Spring |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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Bank Board will be filled only by a majority of the directors then in office, although less than a quorum, or by a sole remaining director, and will not be filled by the stockholders. A director elected to fill a vacancy will hold office until the next election of the class for which such director will have been chosen, subject to the election and qualification of a successor or until such directors earlier death, resignation or removal. | ||||
Voting Stock | F-stars articles of association provide that the holders of Series A Shares, Seed Preferred Shares and Ordinary Shares are each entitled to one vote for each share held on record. | Holders of Spring Bank common stock are entitled to one vote for each share held of record on all matters submitted to a vote of stockholders. | ||
Drag Along | F-stars articles of association provide that if the holders of, in aggregate, at least 65% of F-stars Series A Shares, Seed Preferred Shares and ordinary shares (as if they were the same class) held by Investors (a Qualified Majority) wish to transfer their F-star shares to a third party purchaser, those shareholders are able to require all the other F-star shareholders (including optionholders who become shareholders in F-star on exercise of their share options) to also sell and transfer all their shares to that third-party purchaser. | Spring Bank does not have any drag along terms in place. | ||
Registration Rights | F-stars shareholders agreement provides that in the event of an IPO of F-stars shares the Investors will be entitled to certain registration rights, including: (i) two demand registration rights each year; (ii) unlimited piggy back registrations on all registrations by F-star for its own account; and (iii) the payment by F-star of any registration and legal expenses up to £50,000 (plus value added tax). | |||
Stockholder Action by Written Consent |
Under the Companies Act 2 and as permitted by F-stars articles of association, certain resolutions may be passed in writing, as is usual for a | Spring Banks amended and restated certificate of incorporation does not permit stockholders to act by written consent. Stockholders may only |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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company incorporated in England and Wales. | act at an annual or Special Meeting called in accordance with the amended and restated bylaws. | |||
Notice of Stockholder Meeting |
Under the Companies Act, as a private limited company, at least 14 days notice is required for any general meeting (including any annual general meeting) of F-star. | Under the amended and restated bylaws of Spring Bank, the notice of any meeting of stockholders will be given not less than 10 days nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting. Without limiting the manner by which notice otherwise may be given to stockholders, any notice will be effective if given by a form of electronic transmission (in a manner consistent with the DGCL) by the stockholder to whom the notice is given. | ||
Conversion Rights and Protective Provisions |
F-stars articles of association provide that any holder of Series A Shares and/or Seed Preference Shares shall be entitled, by written notice, to require the conversion of those shares into ordinary shares. A holder of Series A Shares and/or Seed Preference Shares can state in their notice requiring the conversion that such conversion is conditional upon certain events.
All the Series A Shares and Seed Preference Shares will automatically convert into ordinary shares: (a) on the date of a notice given by a Qualified Preference Majority requiring such conversion; or (b) immediately prior to the occurrence of an IPO that meets certain criteria.
On a conversion, the conversion ratio shall be one ordinary share for each Series A Share or Seed Preferred Share held. The Ordinary Shares resulting from the conversion will rank pari passu with all existing Ordinary Shares in issue. |
The amended and restated certificate of incorporation of Spring Bank does not provide that holders of Spring Banks capital stock have preemptive, conversion or other protective rights. | ||
Right of First Refusal | F-stars articles of association provide that, with the exception of transfers to certain permitted transferees, a | Spring Bank does not have a right of first refusal in place. |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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shareholder who desires to transfer their shares to a third party must notify F-star of that intention and then, before the sale, offer those shares to: (i) first, the Investors; and (ii) second, the holders of the ordinary shares (other than the Investors). The sale price will be the price specified by the selling shareholder in its initial sale notice tor a value otherwise agreed by the parties.
Any shares not sold through the above pre-emption process, may be sold to the intended third party at the same agreed price provided that certain requirements are satisfied e.g. the transfer cannot be to a competitor of F-star |
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Right of Co-Sale |
F-stars articles of association provide that where a shareholder who has been through the pre-emption process contained in the articles of association (as explained above) wishes to sell more than 2% of the Equity Shares (but less than a number that constitutes a controlling interest), Investors who have not taken up their pre-emption rights will be entitled to benefit from a co-sale right, enabling them to sell some of their Equity Shares on the same terms proposed by the transferor. The maximum number of shares an Investor can sell is determined as: (X / Y) x Z where:
X = the number of Equity Shares held by the Investor;
Y = the total number of Equity Shares; and
Z = the number of Equity Shares the transferor is proposing to sell. |
Spring Bank does not have a right of co-sale in place. | ||
Forum Selection | F-stars articles of association do not have a provision regarding forum selection. | Spring Banks amended and restated certificate of incorporation provides that, unless Spring Bank consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of Spring Bank to Spring Bank or Spring Banks stockholders, (iii) any action asserting a claim against Spring Bank or any director or officer or other employee of Spring Bank arising pursuant to any provision of the DGCL, or (iv) any action asserting a claim against Spring Bank or any director or officer or other employee of Spring Bank governed by the internal affairs doctrine. For more information see the section titled Description of Spring Bank Capital Stock in this prospectus/information statement. | ||||
Indemnification |
F-stars articles of association provide that, subject to the Companies Act, each of F-stars directors and other officers are entitled to be indemnified by F-star against all liabilities incurred by him in the execution and discharge of his or her duties or in relation to those duties, save that such director or other officer will not be indemnified against: (i) liability incurred by the director to the Company; (ii) liability incurred by the director to pay a fine imposed in criminal proceedings or payable to a regulatory authority in respect of non-compliance with any regulatory requirements; or (iii) liability incurred by the director in defending criminal proceedings in which he is convicted, in defending civil proceedings against him from the Company, or in connection with application under sections 661(3),(4) or 1157 of the Companies Act.
Subject to certain limited exemptions, the Companies Act renders void an indemnity for a director against any liability attaching to him in connection with any negligence, default, breach of |
The amended and restated certificate of incorporation of Spring Bank provides that a director of Spring Bank will not be personally liable to Spring Bank or its stockholders for monetary damages for breach of fiduciary duty as a director to the fullest extent permitted by the DGCL, as amended. The amended and restated certificate of incorporation of Spring Bank further provides that Spring Bank will, to the fullest extent permitted by law, indemnify and advance expenses to any person made or threatened to be made a party to an action, suit or proceeding by reason of the fact that he or she is or was a director or officer of Spring Bank.
The amended and restated bylaws of Spring Bank provide that Spring Bank will indemnify and hold harmless, |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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duty or breach of trust in relation to the company of which he or she is a director. | to the fullest extent permitted by the DGCL, as amended, any director or officer of Spring Bank who was or is made or is threatened to be made a party to any proceeding, except that Spring Bank will be required to indemnify an officer or director in connection with a proceeding initiated by such person only if the proceeding was authorized in the specific case by the Spring Bank Board. These rights are not exclusive of any other rights which such person may have or hereafter acquire under any statute, provision of the certificate of incorporation, the bylaws, agreement, vote of stockholders or disinterested directors or otherwise. | |||
Advancement of Expenses | The Companies Act permits F-star to pay or reimburse a director for certain expenditures incurred by that director in the defense of certain proceedings and investigations brought against him in relation to F-star or an associated company. | The amended and restated certificate of incorporation of Spring Bank provides that, to the fullest extent not prohibited by applicable law, Spring Bank will pay the expenses incurred by any officer or director in defending any proceeding in advance of its final disposition, provided, however, that, to the extent required by law, such payment of expenses in advance of the final disposition of the proceeding will be made only upon receipt of an undertaking by the person to repay all amounts in advance if it should be ultimately determined that the person is not entitled to be indemnified under the amended and restated bylaws of Spring Bank or otherwise. | ||
Dividends Declaration and Payment of Dividends |
F-stars articles of association provide that F-stars distributable profits in respect of any financial year will, if determined by F-stars Board acting with Qualified Majority Consent, be | Subject to the DGCL, Spring Banks Board of Directors may declare any dividend upon the capital stock of Spring Bank. |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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paid as dividends to F-stars shareholders pro rata to their holding of Equity Shares.
In addition, the F-star shareholders agreement provides that F-star may not declare or make payment of any dividend or distribution without first obtaining the written consent of the holders of more than 65% of shares held by the Investors. |
Dividends may be paid in cash, property or capital stock. | |||
General Provisions |
F-stars articles of association may be amended by special resolution (being a resolution passed by the holders of at least 75% of the shares voted), as prescribed by applicable law and F-stars articles of association.
In addition, the F-star shareholders agreement provides that F-star may not amend, modify or repeal any provision of its articles of association without first obtaining the written consent of the holders of more than 65% of shares held by the Investors. |
Spring Banks amended and restated certificate of incorporation may be amended as prescribed by applicable law. Under the DGCL, an amendment to a certificate of incorporation must be approved by a majority of the stock entitled to vote on the amendment (unless a higher vote is required by the corporations certificate of incorporation). Spring Banks amended and restated bylaws may be amended by the Board of Directors or by the stockholders as provided in the amended and restated certificate of incorporation. | ||
Anti-dilution | The F-star articles of association include anti-dilution rights in favor of holders of Series A Shares. | |||
Matters requiring consent |
The F-star shareholders agreement provides that holders of at least 65% of the shares held by the Investors must first consent to the following matters, before they are implemented:
1. any amendments of F-stars articles of association;
2. the merger, the demerger, change of corporate form or any measures that lead to a change in corporate structure of F-star;
3. any increase or decreased of F-stars nominal share capital;
4. the approval of F-stars financial statements |
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Provision |
F-star (Pre-Exchange) |
Spring Bank (Post-Exchange) |
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5. the declaration and payment of any dividends or distributions
6. the liquidation or winding up of F-star;
7. any redemption, repurchase or other acquisition of any securities of F-star;
8. any authorization or any designation of a new class or series of shares in F-star;
9. any increase or decrease in the number of F-stars directors;
10. any public listing of F-stars shares;
11. the implementation of any employee incentive or benefit;
12. any sale, licensing or other disposal of all or substantially all of the undertaking or assets of F-star; and
13. any borrowing or the incurring of any indebtedness by F-star in excess of £500,000 per annum. |
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PRINCIPAL STOCKHOLDERS OF SPRING BANK
Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus do not give effect to the Reverse Stock Split.
The following table sets forth certain information with respect to the beneficial ownership of Spring Bank common stock as of September 15, 2020 for (a) Spring Banks executive officers, (b) each of its directors, (c) all of the current directors and executive officers as a group and (d) each stockholder known to own beneficially more than 5% of Spring Bank common stock. Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities. Spring Bank deems shares of common stock that may be acquired by an individual or group within 60 days of September 15, 2020 pursuant to the exercise of options, warrants or convertible notes to be outstanding for the purpose of computing the percentage ownership of such individual or group, but those shares are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. Except as indicated in footnotes to this table, Spring Bank believes that the stockholders named in this table have sole voting and investment power with respect to all shares of common stock shown to be beneficially owned by them based on information provided to Spring Bank by these stockholders. Percentage of ownership is based on 17,248,545 shares of common stock outstanding on September 15, 2020.
Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Spring Bank Pharmaceuticals, Inc., 35 Parkwood Drive, Suite 210, Hopkinton, MA 01748. Beneficial ownership representing less than one percent of Spring Banks outstanding common stock is denoted with an *.
Name and Address of Beneficial Owner |
Number of
Shares Beneficially Owned |
Percentage
Beneficially Owned |
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5%+ Stockholders: |
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Ridgeback Capital Investments Ltd.(1) |
1,142,900 | 6.6 | % | |||||
Biotechnology Value Fund, L.P.(2) |
951,701 | 5.5 | % | |||||
Other Directors and other Named Executive Officers: |
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Kurt Eichler(3) |
675,864 | 3.9 | % | |||||
R.P. Kris Iyer, Ph.D.(4) |
584,271 | 3.4 | % | |||||
Martin Driscoll(5) |
580,889 | 3.3 | % | |||||
Todd Brady, M.D., Ph.D.(6) |
93,745 | * | ||||||
David Arkowitz(7) |
78,815 | * | ||||||
Timothy Clackson, Ph.D.(8) |
60,842 | * | ||||||
Scott Smith(9) |
55,420 | * | ||||||
Pamela Klein, M.D.(10) |
9,167 | * | ||||||
All Current Directors and Officers as a Group (10 persons)(11) |
2,232,287 | 12.3 | % |
(1) |
This information is based solely on a Schedule 13G filed with the SEC on January 6, 2020. Consists of 1,142,900 shares of common stock beneficially owned by Ridgeback Capital Investments L.P. (RCILP). Ridgeback Capital Management LP (RCM) and Ridgeback Capital Investments Ltd. (RCI) do not own any Shares directly. RCI is the general partner of RCILP. Pursuant to an investment management agreement, RCM maintains investment and voting power with respect to the securities held or controlled by RCI. Wayne Holman, an individual, controls RCM. RCM and RCI may be deemed to own beneficially all of the shares. Each of RCM and RCI disclaim beneficial ownership of any of the securities held by RCILP, except to the extent of any pecuniary interest therein. The address of the principal business office of each of RCILP, RCI and RCM is 500 South Pointe Drive, Suite 220, Miami Beach, Florida 33139. |
(2) |
This information is based solely on a Schedule 13G/A filed with the SEC on February 14, 2020. Consists of 466,424 shares of common stock beneficially owned by Biotechnology Value Fund, L.P. (BVF), 355,132 shares of common stock beneficially owned by Biotechnology Value Fund II, L.P. (BVF2), 72,232 shares of common stock beneficially owned by Biotechnology Value Trading Fund OS LP (Trading Fund OS) and 57,913 shares of common stock in a certain account managed by BVF Partners L.P. (the Partners Managed |
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Account). BVF I GP LLC (BVF GP), as the general partner of BVF, may be deemed to beneficially own the shares beneficially owned by BVF. BVF II GP LLC (BVF2 GP), as the general partner of BVF2, may be deemed to beneficially own the shares beneficially owned by BVF2. BVF Partners OS Ltd. (Partners OS), as the general partner of Trading Fund OS, may be deemed to beneficially own the shares beneficially owned by Trading Fund OS. BVF GP Holdings LLC (BVF GPH), as the sole member of each of BVF GP and BVF2 GP, may be deemed to beneficially own the 821,556 shares beneficially owned in the aggregate by BVF and BVF2. Partners, as the investment manager of BVF, BVF2, and Trading Fund OS, and the sole member of Partners OS, may be deemed to beneficially own the 951,701 Shares beneficially owned in the aggregate by BVF, BVF2, Trading Fund OS, and a certain Partners managed account (the Partners Managed Account), including 57,913 Shares held in the Partners Managed Account. BVF Inc., as the general partner of Partners, may be deemed to beneficially own the shares beneficially owned by Partners and Mr. Lampert, as a director and officer of BVF Inc., may be deemed to beneficially own the shares beneficially owned by BVF Inc. Each of BVF GP, BVF2 GP, Partners OS, BVF GPH, Partners, BVF Inc. and Mr. Lampert disclaims beneficial ownership of the shares of common stock beneficially owned by BVF, BVF2, Trading Fund OS, and the Partners Managed Accounts. The address of the principal business and office of BVF Inc. and certain of its affiliates is 1 Sansome Street, 30th Floor, and San Francisco, California, 94194. |
(3) |
Consists of (i) 549,273 shares held directly by Mr. Eichler, (ii) 31,500 shares of common stock issuable upon the exercise of options held by Mr. Eichler exercisable within 60 days after September 15, 2020, (iii) 64,100 shares of common stock issuable upon the exercise of warrants held by Mr. Eichler exercisable within 60 days after September 15, 2020, (iv) 19,791 shares of Spring Bank common stock held by Teresa Eichler as custodian for Katherine Eichler UGMA NJ and beneficially owned by Mr. Eichler, of which Mr. Eichler has shared voting and investment power, (v) 10,000 shares held by trusts for which Mr. Eichler serves as the trustee, of which Mr. Eichler has sole voting and investment power, and (vi) 1,200 shares are held by Mr. Eichler as custodian for one of his minor children, of which Mr. Eichler has sole voting and investment power. |
(4) |
Consists of (i) 50,000 shares of common stock held directly by Dr. Iyer, (ii) 103,021 shares of common stock issuable upon the exercise of options held by Dr. Iyer exercisable within 60 days after September 15, 2020 and (iii) 431,250 shares of common stock held by a family trust in which Dr. Iyer is a trustee and shares voting and investment control. |
(5) |
Consists of (i) 90,400 shares held by Mr. Driscoll, (ii) 21,900 shares of common stock issuable upon the exercise of warrants held by Mr. Driscoll exercisable within 60 days after September 15, 2020 and (iii) 468,589 shares of common stock issuable upon the exercise of options held by Mr. Driscoll exercisable within 60 days after September 15, 2020. |
(6) |
Consists of (i) 50,781 shares held by Dr. Brady, (ii) 10,964 shares of common stock issuable upon the exercise of warrants held by Dr. Brady exercisable within 60 days after September 15, 2020 and (iii) 32,000 shares of common stock issuable upon the exercise of options held by Dr. Brady exercisable within 60 days of September 15, 2020. |
(7) |
Consists of (i) 37,929 shares held by Mr. Arkowitz, (ii) 4,386 shares of common stock issuable upon the exercise of warrants held by Mr. Arkowitz exercisable within 60 days after September 15, 2020 and (iii) 36,500 shares of common stock issuable upon the exercise of options held by Mr. Arkowitz exercisable within 60 days after September 15, 2020. |
(8) |
Consists of (i) 41,064 shares held by Dr. Clackson and (ii) 19,778 shares of common stock issuable upon the exercise of options held by Dr. Clackson exercisable within 60 days of September 15, 2020. |
(9) |
Consists of (i) 37,476 shares held by Mr. Smith and (ii) 17,944 shares of common stock issuable upon the exercise of options held by Mr. Smith exercisable within 60 days of September 15, 2020. |
(10) |
Consists of 9,167 shares of common stock issuable upon the exercise of options held by Dr. Klein exercisable within 60 days of September 15, 2020. |
(11) |
See footnotes (3) through (10) above. Also includes (i) 66,021 shares of common stock issuable upon the exercise of options held by Garrett Winslow, Spring Banks General Counsel and Corporate Secretary, exercisable within 60 days of September 15, 2020, (ii) 9,169 shares directly or indirectly held by Lori Firmani, Spring Banks Vice President, Finance, and (iii) 18,084 shares of common stock issuable upon the exercise of options held by Ms. Firmani exercisable within 60 days of September 15, 2020. |
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PRINCIPAL SHAREHOLDERS OF F-STAR
The following table sets forth certain information with respect to the beneficial ownership of F-stars ordinary shares as of September 15, 2020 for:
|
each person, or group of affiliated persons, who are known by F-star to beneficially own more than 5% of the outstanding ordinary shares of F-star; |
|
each of F-stars directors as of September 15, 2020; |
|
each of F-stars named executive officers; and |
|
all of the current directors and executive officers of F-star as a group. |
The number of shares beneficially owned by each entity, person, director or executive officer is determined under the rules of the SEC and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership includes any shares as to which the individual has the sole or shared voting power or investment power and also any shares that the individual has the right to acquire within 60 days of September 15, 2020, through the exercise of any stock option, settlement of RSUs or other right. Unless otherwise indicated, each person has sole investment and voting power, or shares such powers with his or her spouse, with respect to the shares set forth in the following table.
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The percentage of ownership is based on 30,646,919 F-star ordinary shares outstanding on September 15, 2020, after giving effect to the conversion of all outstanding F-star preference shares into an aggregate of 1,545,029 F-star ordinary shares and the conversion of all outstanding F-star convertible notes into an aggregate of 12,836,026 F-star ordinary shares, with interest calculated as of November 14, 2020, adjusted as required by the rules promulgated by the SEC to determine beneficial ownership. F-star does not know of any arrangements, including any pledge by any person of securities of F-star, the operation of which may at a subsequent date result in a change of control of F-star.
Name and Address of Beneficial Owner (1) |
Number of
Shares Beneficially Owned (2) |
Percentage of
Beneficial Ownership (3) |
||||||
Named Executive Officers and Directors |
||||||||
Eliot Forster, Ph.D. (4) |
348,779 | 1.1 | % | |||||
Darlene Deptula-Hicks (5) |
101,070 | * | ||||||
Neil Brewis, Ph.D. (6) |
219,036 | * | ||||||
Louis Kayitalire, M.D. (7) |
87,324 | * | ||||||
Nessan Bermingham, Ph.D. (8) |
200,119 | * | ||||||
Edward Benz, M.D. (9) |
29,166 | * | ||||||
Jean-Francois Formela, M.D. (10) |
| | ||||||
Deborah Harland, Ph.D. (11) |
| | ||||||
Patrick Krol (12) |
| | ||||||
Geoffrey Race (13) |
29,166 | * | ||||||
Helmut Schuehsler, Ph.D. (14) |
| | ||||||
All current executive officers and directors as a group (11 persons) |
1,068,024 | 3.4 | % | |||||
|
|
|
|
|||||
5% and Greater Shareholders |
||||||||
Entities affiliated with Atlas Venture Fund
(15)
|
8,757,901 | 28.58 | % | |||||
Coöperatieve Aescap Venture I, U.A.
(16)
|
4,621,612 | 15.08 | % | |||||
Entities affiliated with TVM Life Sciences
(17)
|
3,198,341 | 10.44 | % | |||||
MP Healthcare Venture Management Inc.
(18)
|
2,140,923 | 6.99 | % | |||||
Merck Ventures B.V. (19)
|
3,044,044 | 9.93 | % | |||||
S.R. One, Limited (20)
|
5,463,723 | 17.83 | % |
* |
Indicates beneficial ownership of less than 1% of the total outstanding F-star ordinary shares. |
(1) |
Unless otherwise indicated, the address of such individual is Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT, UK. |
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(2) |
Applicable number of shares beneficially owned is calculated as of September 15, 2020, including any shares that the individual has the right to acquire within 60 days of September 15, 2020. |
(3) |
Applicable percentage ownership is based on 17,810,893 F-star ordinary shares outstanding as of September 15, 2020. |
(4) |
Consists of (i) 164,978 ordinary shares, (ii) 27,308 shares issuable upon the exercise of options in the legacy GmbH Scheme exercisable within 60 days of September 15, 2020, and (iii) 156,493 shares issuable upon the exercise of options outstanding under the F-star EIP exercisable within 60 days of September 15, 2020. |
(5) |
Consists of 101,070 shares issuable upon the exercise of options in the F-star EIP exercisable within 60 days of September 15, 2020. |
(6) |
Consists of (i) 176,380 ordinary shares, (ii) 20,229 shares issuable upon the exercise of options in the legacy GmbH Scheme, and (iii) 22,427 shares issuable upon the exercise of options outstanding under the 2019 F-star EIP exercisable within 60 days of September 15, 2020. |
(7) |
Consists of 87,324 shares issuable upon the exercise of options under the F-star EIP exercisable within 60 days of September 15, 2020. |
(8) |
Consists of 200,119 shares issuable upon the exercise of options in a Non-qualifying plan exercisable within 60 days of September 15, 2020. This does not include share capital held by Atlas Venture Fund VII, L.P. or the ordinary shares issuable upon the conversion of the convertible notes held by Atlas Venture Opportunity Fund I., L.P. |
(9) |
Consists of 29,166 shares issuable upon the exercise of options outstanding under the F-star EIP exercisable within 60 days of September 15, 2020. |
(10) |
This does not include the share capital held by Atlas Venture Fund VII, L.P. or the ordinary shares issuable upon the conversion of the convertible notes held by Atlas Venture Opportunity Fund I., L.P. |
(11) |
This does not include the share capital held by or the ordinary shares issuable upon the conversion of the convertible notes held by S.R. One, Limited, an indirect, wholly-owned subsidiary of GlaxoSmithKline plc. |
(12) |
This does not include the share capital held by or the ordinary shares issuable upon the conversion of the convertible notes held by Coöperatieve Aescap Venture I, U.A. |
(13) |
Consists of 29,166 shares issuable upon the exercise of options outstanding under the F-star EIP. |
(14) |
This does not include the shares held by or the ordinary shares issuable upon the conversion of the convertible notes held by TVM Life Science Ventures VI GmbH & Co. KG and TVM Life Science Ventures VI L.P. |
(15) |
Consists of (i) 103,611 ordinary shares issuable upon conversion of Series Seed Preferred shares held by Atlas Venture Fund VII, L.P., (ii) 313,661 ordinary shares issuable upon conversion of Series A Preferred shares held by Atlas Venture Fund VII, L.P., (iii) 4,693,801 ordinary shares held by Atlas Venture Fund VII, L.P., and (iv) 3,646,828 ordinary shares issuable upon conversion of $4,300,247 of convertible notes, interest calculated as of November 14, 2020 held by Atlas Venture Opportunity Fund I, L.P. Atlas Venture Associates VII, L.P. (AVA VII LP) is the sole general partner of Atlas Venture Fund VII, L.P. Atlas Venture Associates VII, Inc. (AVA VII Inc.) is the sole general partner of AVA VII LP. Peter Barrett, Bruce Booth, Jeff Fagnan and Jean-Francois Formela are each directors of AVA VII Inc (collectively referred to as AVA Directors). Nessan Bermingham, Ph.D., a Venture Partner of Atlas Venture, and Jean-Francois Formela, M.D., a partner of Atlas Venture, are members of F-stars board of directors. Atlas Venture Associates Opportunity I, L.P. (AVAO I LP) is the sole general partner of Atlas Venture Opportunity Fund I, L.P. Atlas Venture Associates Opportunity I, LLC (AVAO I LLC) is the sole general partner of AVAO I LP. Bruce Booth, Kevin Bitterman, Jason Rhodes, David Grayzel and Jean-Francois Formela are each members of AVAO I LLC (collectively referred to as AVAO Members). Each of AVA VII LP, AVA VII Inc., the AVA Directors, AVAO I LP, AVAO I LLC, the AVA Members and Nessan Bermingham disclaim beneficial ownership of the shares, except to the extent of their proportionate pecuniary interest therein, if any. |
(16) |
Consists of (i) 302,880 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 3,407,025 ordinary shares, and (iii) 911,707 ordinary shares issuable upon conversion of $1,075,068 of convertible notes, interest calculated as of November 14, 2020. Hans Bosman, Michiel de Haan and Patrick Krol have a joint voting and investment power of the securities held by Coöperatieve Aescap Venture I, U.A. |
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(17) |
Consists of (i) 130,778 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,471,079 ordinary shares held by TVM Life Science Ventures VI GmbH & Co. KG (TVM VI), (iii) 36,254 ordinary shares issuable upon conversion of Series A Preferred shares, (iv) 407,833 ordinary shares held by TVM Life Science Ventures VI L.P. (TVM VI LP), (v) 902,590 ordinary shares issuable upon conversion of $1,064,318 of convertible notes held by TVM VI, interest calculated as of November 14, 2020, and (vi) 249,807 ordinary shares issuable upon conversion of $294,569 of convertible notes, interest calculated as of November 14, 2020 held by TVM VI LP. Hubert Birner and Stefan Fischer are members of the investment committee of TVM Life Science Ventures Management VI L.P. (TVM VI Management), a special limited partner of each of TVM VI and TVM VI LP, with voting and dispositive power over the shares held by TVM VI and TVM VI LP. |
(18) |
Consists of (i) 100,353 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,128,863 ordinary shares, and (iii) 911,707 ordinary shares issuable upon conversion of $1,075,068 of convertible notes, interest calculated as of November 14, 2020. Jeffrey B. Moore, DPhil, MBA, President of MP Healthcare Ventures Inc., with approval from the MP Healthcare Venture Management Inc. board of directors, has voting and investment power of the securities held by MP Healthcare Venture Management Inc. |
(19) |
Consists of (i) 99,653 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,120,977 ordinary shares, and (iii) 1,823,414 ordinary shares issuable upon conversion of $2,150,137 of convertible notes, interest calculated as of November 14, 2020. Merck Ventures B.V. is a wholly owned subsidiary of Merck B.V. Merck B.V. may be deemed to have sole voting and dispositive power with respect to the shares held by Merck Ventures B.V. Merck Ventures B.V. is a wholly owned indirect subsidiary of Merck KGaA, a publicly traded company (Frankfurt Stock Exchange, DAX 30). Merck KGaA may be deemed to have sole voting and dispositive power with respect to the shares held by Merck Ventures B.V. |
(20) |
Consists of (i) 148,333 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,668,562 ordinary shares, and (iii) 3,646,828 ordinary shares issuable upon conversion of $4,300,274 of convertible notes, interest calculated as of November 14, 2020. S.R. One, Limited, is an indirect, wholly-owned subsidiary of GlaxoSmithKline plc. GlaxoSmithKline plc has sole voting and investment power of the securities held by S.R. One, Limited. |
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PRINCIPAL STOCKHOLDERS OF THE COMBINED COMPANY
Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus do not give effect to the Reverse Stock Split.
The following table sets forth certain information with respect to the beneficial ownership of the combined companys common stock immediately after the Closing:
|
each person, or group of affiliated persons, expected by Spring Bank and F-star to become the beneficial owner of more than 5% of the outstanding common stock of the combined company; |
|
each person expected to be a named executive officer or director of the combined company; and |
|
all of the combined companys executive officers and directors as a group. |
The number of shares beneficially owned by each entity, person, director or executive officer is determined under the rules of the SEC and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership includes any shares as to which the individual has the sole or shared voting power or investment power and also any shares that the individual has the right to acquire within 60 days of September 15, 2020, through the exercise of any stock option, settlement of RSUs or other right. Unless otherwise indicated, Spring Bank and F-star believe, based on the information furnished to each company, that the persons named in the table below have sole investment and voting power, or shares such powers with his or her spouse, with respect to the shares set forth in the following table.
The percentage of ownership is based on 46,067,084 shares of common stock expected to be outstanding upon the Closing, adjusted as required by the rules promulgated by the SEC to determine beneficial ownership. Neither Spring Bank nor F-star know of any arrangements, including any pledge by any person of securities of the combined company.
Immediately after the consummation of the Exchange, based on the Exchange Ratio of 0.5338, it is expected that F-star securityholders will own approximately 61.2% of Spring Bank common stock, and Spring Bank securityholders will own approximately 38.8% of Spring Bank common stock, subject to adjustment of the Exchange Ratio as set forth in the Exchange Agreement and taking into account an assumed Pre-Closing Financing of $25.0 million described in this proxy statement/prospectus. The initial Exchange Ratio set forth above assumes (i) that Spring Bank will have between $15.0 million and $17.0 million in net cash immediately prior to Closing, (ii) a Pre-Closing Financing amount of $25.0 million, (iii) Spring Bank outstanding shares as of the Closing will be equal to 17,864,680, (iv) that all outstanding and unexercised Spring Bank options immediately prior to the Closing have an exercise price equal to or greater than the current trading price for shares of Spring Bank common stock at the Closing and (v) F-star outstanding shares as of the Closing will be equal to 30,646,919, after giving effect to the conversion of all outstanding F-star preference shares and F-star convertible notes with interest calculated as of November 14, 2020 into F-star ordinary shares.
The Exchange Ratio is calculated using a formula intended to allocate a percentage of the combined company to existing F-stars Securityholders. Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the Spring Bank securityholders and the holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion and Pre-Closing Financing) are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company.
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The following table and the related notes assume that each F-star ordinary share will convert into the right to receive 0.5338 shares of Spring Bank Common Stock and to account for the occurrence of certain events discussed elsewhere in this proxy statement/prospectus. See The Exchange AgreementExchange Consideration in this prospectus/information statement for more information regarding the Exchange Ratio.
Name and Address of Beneficial Owner (1) |
Number of
Shares Beneficially Owned (2) |
Percentage of
Beneficial Ownership (3) |
||||||
Named Executive Officers and Directors |
||||||||
Eliot Forster, Ph.D. (4) |
|
186,178
|
(4)
|
* | ||||
Darlene Deptula-Hicks (5) |
53,951 | (5) | * | |||||
Neil Brewis, Ph.D. (6) |
116,921 | (6) | * | |||||
Louis Kayitalire, M.D. (7) |
46,613 | (7) | * | |||||
Nessan Bermingham, Ph.D. (8) |
106,823 | (8) | * | |||||
Edward Benz, M.D. (9) |
15,568 | (9) | * | |||||
Geoffrey Race (10) |
15,568 | (10) | * | |||||
Pamela Klein, M.D. (11) |
9,167 | (11) | * | |||||
Patrick Krol (12) |
| (12) | * | |||||
Todd Brady, M.D., Ph.D. (13) |
93,745 | (13) | * | |||||
David Arkowitz (14) |
78,815 | (14) | * | |||||
All executive officers and directors as a group (11 persons) |
723,349 | 1.6 | % | |||||
|
|
|
|
|||||
5% and Greater Stockholders |
||||||||
Entities affiliated with Atlas Venture
(15)
|
4,674,968 | (15) | 10.2 | % | ||||
Coöperatieve Aescap Venture I, U.A.
(16)
|
2,467,016 | (16) | 5.4 | % | ||||
S.R. One, Limited (17)
|
2,916,535 | (17) | 6.3 | % |
* |
Indicates beneficial ownership of less than 1% of the total outstanding F-star ordinary shares. |
(1) |
Unless otherwise indicated, the address of such individual is Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT, UK. |
(2) |
Applicable number of shares of stock beneficially owned is calculated as of September 15, 2020, including any shares of stock that the individual has the right to acquire within 60 days of September 15, 2020. |
(3) |
Applicable percentage ownership is based on 46,067,084 shares of common stock outstanding as of September 15, 2020. |
(4) |
Consists of (i) 88,065 ordinary shares, (ii) 14,577 shares issuable upon the exercise of options in the legacy GmbH Scheme exercisable within 60 days of September 15, 2020, and (iii) 83,536 shares issuable upon the exercise of options outstanding under the F-star EIP exercisable within 60 days of September 15, 2020. |
(5) |
Consists of 53,951 shares issuable upon the exercise of options in the F-star EIP exercisable within 60 days of September 15, 2020. |
(6) |
Consists of (i) 94,151 ordinary shares, (ii) 10,798 shares issuable upon the exercise of options in the legacy GmbH Scheme, and (iii) 11,971 shares issuable upon the exercise of options outstanding under the F-star EIP exercisable within 60 days of September 15, 2020. |
(7) |
Consists of 46,613 shares issuable upon the exercise of options under the F-star EIP exercisable within 60 days of September 15, 2020. |
(8) |
Consists of 106,823 shares issuable upon the exercise of options in a Non-qualifying plan exercisable within 60 days of September 15, 2020. This does not include share capital held by Atlas Venture Fund VII, L.P. or |
363
the ordinary shares issuable upon the conversion of the convertible notes held by Atlas Venture Opportunity Fund I., L.P. |
(9) |
Consists of 15,569 shares issuable upon the exercise of options outstanding under the F-star EIP exercisable within 60 days of September 15, 2020. |
(10) |
Consists of 15,569 shares issuable upon the exercise of options outstanding under the F-star EIP. |
(11) |
Consists of 9,167 shares of common stock issuable upon the exercise of fully vested and exercisable options held by Dr. Klein. |
(12) |
This does not include the share capital held by or the ordinary shares issuable upon the conversion of the convertible notes held by Coöperatieve Aescap Venture I, U.A. |
(13) |
Consists of (i) 50,781 shares held by Dr. Brady, (ii) 10,964 shares of common stock issuable upon the exercise of warrants held by Dr. Brady exercisable within 60 days after September 15, 2020 and (iii) 32,000 shares of common stock issuable upon the exercise of fully vested and exercisable options held by Dr. Brady. |
(14) |
Consists of (i) 37,929 shares held by Mr. Arkowitz, (ii) 4,386 shares of common stock issuable upon the exercise of warrants held by Mr. Arkowitz exercisable within 60 days after September 15, 2020 and (iii) 36,500 shares of common stock issuable upon the exercise of fully vested and exercisable options held by Mr. Arkowitz. |
(15) |
Consists of (i) 55,307 ordinary shares issuable upon conversion of Series Seed Preferred shares held by Atlas Venture Fund VII, L.P., (ii) 167,432 ordinary shares issuable upon conversion of Series A Preferred shares held by Atlas Venture Fund VII, L.P., (iii) 2,505,550 ordinary shares held by Atlas Venture Fund VII, L.P., and (iv) 1,946,676 ordinary shares issuable upon conversion of $4,313,425 of convertible notes, interest calculated as of November 14, 2020 held by Atlas Venture Opportunity Fund I, L.P. Atlas Venture Associates VII, L.P. (AVA VII LP) is the sole general partner of Atlas Venture Fund VII, L.P. Atlas Venture Associates VII, Inc. (AVA VII Inc.) is the sole general partner of AVA VII LP. Peter Barrett, Bruce Booth, Jeff Fagnan and Jean-Francois Formela are each directors of AVA VII Inc (collectively referred to as AVA Directors). Nessan Bermingham, Ph.D., a Venture Partner of Atlas Venture, and Jean-Francois Formela, M.D., a partner of Atlas Venture, are members of F-stars board of directors. Atlas Venture Associates Opportunity I, L.P. (AVAO I LP) is the sole general partner of Atlas Venture Opportunity Fund I, L.P. Atlas Venture Associates Opportunity I, LLC (AVAO I LLC) is the sole general partner of AVAO I LP. Bruce Booth, Kevin Bitterman, Jason Rhodes, David Grayzel and Jean-Francois Formela are each members of AVAO I LLC (collectively referred to as AVAO Members). Each of AVA VII LP, AVA VII Inc., the AVA Directors, AVAO I LP, AVAO I LLC, the AVA Members and Nessan Bermingham disclaim beneficial ownership of the shares, except to the extent of their proportionate pecuniary interest therein, if any. |
(16) |
Consists of (i) 161,677 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 1,818,669 ordinary shares, and (iii) 486,669 ordinary shares issuable upon conversion of $1,075,068 of convertible notes, interest calculated as of November 14, 2020. Hans Bosman, Michiel de Haan and Patrick Krol have a joint voting and investment power of the securities held by Coöperatieve Aescap Venture I, U.A. |
(17) |
Consists of (i) 79,180 ordinary shares issuable upon conversion of Series A Preferred shares, (ii) 890,678 ordinary shares, and (iii) 1,946,676 ordinary shares issuable upon conversion of $4,300,274 of convertible notes, interest calculated as of November 14, 2020. S.R. One, Limited, is an indirect, wholly-owned subsidiary of GlaxoSmithKline plc. GlaxoSmithKline plc has sole voting and investment power of the securities held by S.R. One Limited. |
364
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. will pass upon the validity of the Spring Bank common stock offered by this proxy statement/prospectus. The material U.S. federal income tax consequences of the Exchange will be passed upon for Spring Bank and for F-star by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston, Massachusetts.
The consolidated financial statements of Spring Bank Pharmaceuticals, Inc. and its subsidiaries as of December 31, 2019 and 2018 and for the years then ended have been audited by RSM US LLP, an independent registered public accounting firm, as stated in their report thereon, and have been included in this Prospectus and Registration Statement in reliance upon such report and upon the authority of such firm as experts in accounting and auditing.
The financial statements of F-star Therapeutics Limited as of December 31, 2019, 2018 and 2017 and for each of the three years in the period ended December 31, 2019 included in this Prospectus have been so included in reliance on the report (which contains an explanatory paragraph relating to the Companys restatement of its financial statements as described in Note 4.9 to the financial statements and an explanatory paragraph relating to the Companys ability to continue as a going concern as described in Note 2.2 to the financial statements) of PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
The financial statements of F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H as of May 6, 2019, December 31, 2018 and 2017 and for the period ended May 6, 2019 and the years ended December 31, 2018 and 2017 included in this Prospectus have been so included in reliance on the report (which contains an explanatory paragraph relating to the Companys ability to continue as a going concern as described in Note 2.2 to the financial statements) of PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
The financial statements of F-star Beta Limited as of May 6, 2019, December 31, 2018 and 2017 and for the period ended May 6, 2019 and the years ended December 31, 2018 and 2017 included in this Prospectus have been so included in reliance on the report (which contains an explanatory paragraph relating to the Companys ability to continue as a going concern as described in Note 2.2 to the financial statements) of PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
Spring Bank files annual, quarterly and current reports, proxy and information statements and other information with the SEC. The SEC also maintains an internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The address of that site is www.sec.gov.
As of the date of this proxy statement/prospectus, Spring Bank has filed a registration statement on Form S-4 to register with the SEC the Spring Bank common stock that Spring Bank will issue to F-star shareholders in the Exchange. This proxy statement/prospectus is a part of that registration statement and constitutes a prospectus of Spring Bank, as well as a proxy statement of Spring Bank for the Special Meeting.
Spring Bank has supplied all information contained in this proxy statement/prospectus relating to Spring Bank, and F-star has supplied all information contained in this proxy statement/prospectus relating to F-star.
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If you would like to request documents from Spring Bank or F-star, please send a request in writing or by telephone to either Spring Bank or F-star at the following addresses:
Spring Bank Pharmaceuticals, Inc. 35 Parkwood Drive, Suite 210 Hopkinton, Massachusetts 01748 Telephone: (508) 473-5993 Attn: General Counsel and Corporate Secretary |
F-star Therapeutics Limited Eddeva B920 Babraham Research Campus Cambridge, CB22 3AT United Kingdom Telephone: +44-1223 497400 Attn: General Counsel |
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Stockholder Proposals
Spring Banks stockholders are entitled to present proposals for action at a forthcoming meeting if they comply with the requirements of Spring Banks amended and restated bylaws and the rules established by the SEC under the Exchange Act.
To be considered for inclusion in the proxy statement relating to Spring Banks 2021 annual meeting of stockholders, Spring Bank must receive stockholder proposals (other than for director nominations) no later than December 30, 2020, which is 120 days prior to the first anniversary of the mailing date of Spring Banks proxy statement filed in connection with the 2020 annual meeting of stockholders. However, if the date of the 2021 annual meeting of stockholders is changed by more than 30 days from the anniversary of Spring Banks 2020 annual meeting, the deadline for such proposals will be a reasonable time before Spring Bank begins to print and send proxy materials. These proposals must comply with the requirements as to form and substance established by the SEC for such proposals in order to be included in Spring Banks proxy statement.
In addition, for proposals to be considered for presentation at Spring Banks 2021 annual meeting of stockholders, although not included in the proxy statement (including nominations that are not requested to be included in Spring Banks proxy statement), Spring Banks amended and restated bylaws require that notice must be received at Spring Banks principal executive offices not less than 90 calendar days nor more than 120 calendar days prior to the one year anniversary of the previous years annual meeting of stockholders. Therefore, to be presented at Spring Banks 2021 annual meeting of stockholders, such a proposal must be received by Spring Bank no earlier than February 24, 2021 and no later than March 26, 2021 or it will be considered untimely. However, if the date of the 2021 annual meeting is advanced by more than 30 days, or delayed by more than 60 days, from the first anniversary date of Spring Banks 2020 annual meeting, notice must be received no earlier than 120 calendar days prior to such annual meeting and no later than the close of business on the later of (i) 90 days prior to such annual meeting and (ii) the tenth day following the day on which notice of the date of such annual meeting was mailed or public announcement of the date of such annual meeting was first made, whichever first occurs. If the stockholder fails to give notice by these dates, then the persons named as proxies in the proxies solicited by the Board of Directors for the 2021 annual meeting may exercise discretionary voting power regarding any such proposal. Stockholders are advised to review Spring Banks amended and restated bylaws which also specify requirements as to the form and content of a stockholders notice.
Any proposals, notices or information about proposed director candidates should be sent to:
Spring Bank Pharmaceuticals, Inc.
35 Parkwood Drive, Suite 210
Hopkinton, Massachusetts 01748
Attention: Corporate Secretary
Stockholder Communications with the Spring Bank Board
Spring Bank stockholders may communicate with the Spring Bank Board, or an individual director, by sending written correspondence to Spring Banks Secretary at Spring Bank Pharmaceuticals, Inc., 35 Parkwood Drive, Suite 210, Hopkinton, Massachusetts 01748. The Secretary will review such correspondence and forward it to the Spring Bank Board, or an individual director, as appropriate.
Householding of Proxy Materials
The SEC has adopted rules known as householding that permit companies and intermediaries (such as brokers) to deliver one set of proxy materials to multiple stockholders residing at the same address. This process enables Spring Bank to reduce Spring Banks printing and distribution costs, and reduce Spring Banks environmental impact. Householding is available to both Spring Bank registered stockholders and beneficial owners of Spring Bank shares held in street name.
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Spring Bank will promptly deliver a separate copy of either document to you upon written or oral request to Spring Bank Pharmaceuticals, Inc., 35 Parkwood Drive, Suite 210, Hopkinton, Massachusetts 01748, Attention: Corporate Secretary, Telephone: (508) 473-5993. If you want to receive separate copies of a proxy statement or annual report to stockholders in the future, or if you are receiving multiple copies and would like to receive only one copy per household, you should contact your bank, broker or other nominee record holder, or you may contact Spring Bank at the above address and phone number.
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UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
On July 29, 2020, Spring Bank Pharmaceuticals, Inc. (Spring Bank), F-star Therapeutics Limited (F-star) and certain holders of issued and outstanding capital shares and convertible promissory notes of F-star (each a Seller; collectively, the Sellers) entered into a share exchange agreement (the Exchange Agreement). The Exchange Agreement contains the terms and conditions of the proposed business combination of Spring Bank and F-star. Under the Exchange Agreement, Spring Bank will acquire the entire issued and outstanding share capital of F-star (including all shares issuable in connection with the F-star Note Conversion, the Pre-Closing Financing and the F-star Share Conversion (in each case, as defined below))(the Exchange).
F-stars issued share capital currently consists of ordinary shares, Seed Preference Shares and Series A Preference Shares. Immediately prior to the closing of the Exchange (the Closing), the Seed Preference Shares and Series A Preference Shares will be converted into F-star ordinary shares (the F-star Share Conversion). Additionally, pursuant to the terms of the Exchange Agreement and immediately prior to the Closing, all issued and outstanding F-star convertible loan notes will convert into F-star ordinary shares (the F-star Note Conversion).
At the Closing, each ordinary share of F-star will be sold to Spring Bank in exchange for a number of shares of Spring Bank common stock, based on the exchange ratio formula in the Exchange Agreement (the Exchange Ratio), rounded down to the nearest whole share of Spring Bank common stock after aggregating all fractional shares issuable to each Seller.
Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the Spring Bank securityholders and holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion and Pre-Closing Financing) are expected to own approximately 38.8% and 61.2%, respectively, of the outstanding capital stock of the combined company.
The Exchange Ratio is subject to adjustment and the respective ownership percentages for F-star and Spring Bank stockholders will change (i) to the extent that Spring Banks expected net cash as of Closing is less than $15.0 million or greater than $17.0 million, (ii) to the extent that F-star does not raise at least $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million, and (iii) to account for the actual proceeds raised in the Pre-Closing Financing. Should the Closing occur after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. The assumed valuations and Exchange Ratio are likely to change, and the parties currently expect the Closing to occur during the fourth quarter of 2020. These and other adjustments to the Exchange Ratio are described further in this prospectus/proxy statement. The potential impact of these terms has not been considered in the estimation of the number of shares of Spring Bank commons stock that will be issued to holders of F-star shares to complete the Exchange for purposes of calculating pro forma earnings per share amounts presented below. These terms are not expected to have a material impact on the number of shares transferred. In addition, Spring Bank stockholders will receive contingent value rights (CVRs) for each share of Spring Bank common stock held of record as of immediately prior to the Closing that provide for the potential payment of additional consideration related to future revenues generated from the furtherance of specific ongoing Spring Bank research and development projects. The CVRs have been considered in the purchase price allocation and an amount of $0.2 million is included in other long term liabilities the pro forma statements below.
The following unaudited pro forma condensed combined financial statements give effect to the exchange of all of the outstanding shares of F-star for newly-issued shares of Spring Bank in the Exchange, pursuant to the Exchange Agreement between the companies, and were prepared in accordance with the regulations of the Securities and Exchange Commission (the SEC). F-star was determined to be the accounting acquirer based upon the terms of the Exchange and other factors including: (i) F-stars security holders are expected to own over 60% of the combined company, (ii) F-stars directors will hold a majority of the board seats in the combined company, and (iii) F-star management will hold all key positions in the management of the combined company, immediately following the closing of the Exchange.
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In the unaudited pro forma condensed combined financial statements, the Exchange will be recorded as a business combination using the acquisition method of accounting under accounting principles generally accepted in the United States (U.S. GAAP). The Exchange will be accounted for as a reverse acquisition under the accounting guidance and F-star, as the accounting acquirer, will record the assets acquired and liabilities assumed of Spring Bank in the Exchange at their fair values as of the acquisition date. Spring Bank and F-star have determined a preliminary estimated purchase price calculated as described in Note 2 to the unaudited pro forma condensed combined financial statements. The net tangible and intangible assets acquired and liabilities assumed in connection with the Exchange are recorded at their estimated acquisition date fair values. A final determination of these estimated fair values will be based on the estimated net tangible and intangible assets and liabilities of Spring Bank that exist as of the date of completion of the Exchange.
The unaudited pro forma condensed combined balance sheet as of June 30, 2020 gives effect to the Exchange as if it took place on June 30, 2020 and combines the historical balance sheets of Spring Bank and F-star as of such date. The unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2020 and for the year ended December 31, 2019 gives effect to the Exchange as if it took place as of January 1, 2019, and combines the historical results of Spring Bank and F-star, and F-star predecessor entities as discussed in Note 4, for each period. The historical financial statements of Spring Bank and F-star have been adjusted to give pro forma effect to events that are (i) directly attributable to the Exchange, (ii) factually supportable, and (iii) with respect to the unaudited pro forma condensed combined statements of operations, at the date hereof are expected to have a continuing impact on the combined companies results.
The unaudited pro forma condensed combined financial information is based on the assumptions and adjustments that are described in the accompanying notes. The unaudited pro forma condensed combined financial statements and pro forma adjustments have been prepared based on preliminary estimates of fair value of assets acquired and liabilities assumed. Differences between these preliminary estimates and the final acquisition accounting are likely to occur and these differences could be material as compared to the accompanying unaudited pro forma condensed combined financial statements and the combined companies future results of operations and financial position. The actual amounts recorded as of the completion of the Exchange may also differ materially from the information presented in these unaudited condensed combined pro forma financial statements as a result of, among other factors, the amount of capital raised by F-star between entering the Exchange Agreement and closing of the Exchange; the amount of cash used in Spring Banks operations between the signing of the Exchange Agreement and the closing of the Exchange; the timing of closing of the Exchange; changes in the fair value of Spring Bank common stock; and other changes in Spring Bank assets and liabilities that occur prior to the completion of the Exchange.
The unaudited pro forma condensed combined financial information does not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the integration of the two companies, if any. The unaudited pro forma condensed combined financial information is preliminary and has been prepared for informational purposes only and is not necessarily indicative of the financial position or results of operations in future periods or the results that actually would have been realized had Spring Bank and F-star been a combined company during the specified periods. The actual results reported in periods following the Exchange are expected to differ significantly from those reflected in the unaudited pro forma condensed combined financial information presented herein for a number of reasons, including, but not limited to, reduction in the Spring Bank workforce, wind down of certain Spring Bank clinical trials, sales of assets and actual differences from the assumptions used to prepare the pro forma financial information.
The unaudited pro forma condensed combined financial information, including the notes thereto, should be read in conjunction with the separate Spring Bank and F-star historical financial statements, and their respective managements discussion and analysis of financial condition and results of operations included elsewhere in this proxy statement/prospectus. F-stars historical financial statements included in this proxy statement/prospectus were prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). Note 4, below, discusses adjustments made to conform F-stars financial statements to U.S. GAAP. Financial statements have also been provided for F-star predecessor entities. Refer to Note 5 below for more details on the F-star reorganization during 2019.
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Unaudited Pro Forma Condensed Combined Balance Sheet
June 30, 2020
(in millions)
F-star
GAAP Adjusted |
Historic
Spring Bank |
Pro Forma
Adjustments |
Pro Forma
Combined |
Notes | ||||||||||||||||
Assets | ||||||||||||||||||||
Current assets |
||||||||||||||||||||
Cash and cash equivalents |
$ | 2.7 | $ | 8.5 | $ | 25.0 | $ | 36.2 | A | |||||||||||
Marketable securities |
| 15.0 | | 15.0 | ||||||||||||||||
Trade and other receivables |
2.5 | | | 2.5 | ||||||||||||||||
Prepaid expenses and other current assets |
4.2 | 2.7 | | 6.9 | ||||||||||||||||
|
|
|
|
|
|
|
|
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Total current assets |
9.4 | 26.2 | 25.0 | 60.6 | ||||||||||||||||
Property and equipment, net |
1.0 | 2.0 | (0.5 | ) | 2.5 | C | ||||||||||||||
Lease right of use assets |
0.2 | 2.6 | 0.1 | 2.9 | C | |||||||||||||||
Intangible assets, net |
12.1 | | 1.0 | 13.1 | C | |||||||||||||||
Other assets |
0.1 | 0.3 | | 0.4 | ||||||||||||||||
Goodwill |
3.9 | | 1.4 | 5.3 | D | |||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total assets |
$ | 26.7 | $ | 31.1 | $ | 27.0 | $ | 84.8 | ||||||||||||
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|
|
|
|
|
|
|
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Liabilities and Stockholders Equity |
|
|||||||||||||||||||
Current liabilities: |
||||||||||||||||||||
Accounts payable |
$ | 12.3 | $ | 2.5 | | $ | 14.8 | |||||||||||||
Accrued expenses and other current liabilities |
0.6 | 2.3 | $ | 6.5 | 9.4 | E | ||||||||||||||
Lease liability |
0.2 | 0.4 | | 0.6 | ||||||||||||||||
Convertible notes |
17.8 | | (17.8 | ) | | B | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total current liabilities |
30.9 | 5.2 | (11.3 | ) | 24.8 | |||||||||||||||
Non-current liabilities: |
||||||||||||||||||||
Lease liability, noncurrent |
| 2.7 | | 2.7 | ||||||||||||||||
Other long-term liabilities |
| | 0.4 | 0.4 | C | |||||||||||||||
|
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|
|
|
|
|
|
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Total non-current liabilities |
| 2.7 | 0.4 | 3.1 | ||||||||||||||||
Stockholders equity: |
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Preferred Stock |
| | | | ||||||||||||||||
Common Stock |
0.2 | | (0.2 | ) | | F | ||||||||||||||
Additional paid-in capital |
26.8 | 164.1 | 25.0 | 90.6 | A | |||||||||||||||
17.8 | B | |||||||||||||||||||
(143.1 | ) | E, F | ||||||||||||||||||
Accumulated other comprehensive income |
| | | | ||||||||||||||||
Accumulated deficit |
(31.2 | ) | (140.9 | ) | 140.9 | (33.7 | ) | F | ||||||||||||
(2.5 | ) | E | ||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total stockholders equity (deficit) |
(4.2 | ) | 23.2 | 37.9 | 56.9 | |||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total liabilities and stockholders equity |
$ | 26.7 | $ | 31.1 | $ | 27.0 | $ | 84.8 | ||||||||||||
|
|
|
|
|
|
|
|
See accompanying notes to the unaudited pro forma condensed combined financial statements.
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Unaudited Pro Forma Condensed Combined Statement of Operations
For the Six Months Ended June 30, 2020
(in millions, except share and per share amounts)
F-star
GAAP Adjusted |
Historic
Spring Bank |
Pro Forma
Adjustments |
Pro Forma
Combined |
Notes | ||||||||||||||||
Revenue |
$ | 1.9 | $ | | $ | | $ | 1.9 | ||||||||||||
Operating Expenses: |
||||||||||||||||||||
Research and development |
5.9 | 8.5 | | 14.4 | ||||||||||||||||
General and administrative |
6.3 | 5.1 | | 11.4 | ||||||||||||||||
Other operating (income) expense, net |
1.2 | | | 1.2 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total operating expenses |
13.4 | 13.6 | | 27.0 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss from operations |
(11.5 | ) | (13.6 | ) | | (25.1 | ) | |||||||||||||
Interest income (expense), net |
(0.5 | ) | (0.2 | ) | 0.5 | (0.2 | ) | B | ||||||||||||
Change in fair value of liabilities |
(1.9 | ) | 0.3 | 1.9 | 0.3 | B | ||||||||||||||
Other non-operating income (expense), net |
| (1.2 | ) | | (1.2 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss before tax |
(13.9 | ) | (14.7 | ) | 2.4 | (26.2 | ) | |||||||||||||
Income tax benefit (expense) |
| | | |||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Net loss |
$ | (13.9 | ) | $ | (14.7 | ) | $ | 2.4 | $ | (26.2 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Net loss per share, basic and diluted |
$ | (0.78 | ) | $ | (0.88 | ) | $ | (0.62 | ) | |||||||||||
|
|
|
|
|
|
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Weighted-average common shares outstanding, basic and diluted |
16,243,171 | 16,787,919 | 41,953,752 | G | ||||||||||||||||
|
|
|
|
|
|
See accompanying notes to the unaudited pro forma condensed combined financial statements.
372
Unaudited Pro Forma Condensed Combined Statement of Operations
For the Year Ended December 31, 2019
(in millions, except share and per share amounts)
F-star
GAAP Adjusted |
Historic
Spring Bank |
Pro Forma
Adjustments |
Pro Forma
Combined |
Notes | ||||||||||||||||
Revenue |
$ | 29.9 | $ | | $ | | $ | 29.9 | ||||||||||||
Operating Expenses: |
||||||||||||||||||||
Research and development |
41.9 | 23.3 | | 65.2 | ||||||||||||||||
General and administrative |
21.3 | 9.7 | | 31.0 | ||||||||||||||||
Other operating (income) expense, net |
(1.3 | ) | | | (1.3 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total operating expenses |
61.9 | 33.0 | | 94.9 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss from operations |
(32.0 | ) | (33.0 | ) | | (65.0 | ) | |||||||||||||
Interest income (expense), net |
(0.4 | ) | 0.7 | 0.2 | 0.5 | B | ||||||||||||||
Change in fair value of liabilities |
(1.5 | ) | 8.2 | 1.5 | 8.2 | B | ||||||||||||||
Other non-operating income (expense), net |
| | | |||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss before tax |
(33.9 | ) | (24.1 | ) | 1.7 | (56.3 | ) | |||||||||||||
Income tax benefit (expense) |
1.5 | | | 1.5 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Net loss |
$ | (32.4 | ) | $ | (24.1 | ) | $ | 1.7 | $ | (54.8 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Net loss per share, basic and diluted |
$ | (2.20 | ) | $ | (1.46 | ) | $ | (1.32 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||||||
Weighted-average common shares outstanding, basic and diluted |
13,734,903 | 16,454,083 | 41,619,916 | G | ||||||||||||||||
|
|
|
|
|
|
See accompanying notes to the unaudited pro forma condensed combined financial statements.
373
Notes to the Unaudited Pro Forma Condensed Combined Financial Information
1. |
Description of the Transaction, Basis of Presentation |
Description of the Transaction
On July 29, 2020, Spring Bank, F-star and the Sellers entered into Exchange Agreement. The Exchange Agreement contains the terms and conditions of the proposed business combination of Spring Bank and F-star. Under the Exchange Agreement and pursuant to the Exchange, Spring Bank will acquire the entire issued and outstanding share capital of F-star. F-stars issued share capital currently consists of ordinary shares, Seed Preference Shares and Series A Preference Shares.
At the Closing, each ordinary share of F-star will be sold to Spring Bank in exchange for a number of shares of Spring Bank common stock, based on the Exchange Ratio, rounded to the nearest whole share of Spring Bank common stock after aggregating all fractional shares issuable to each Seller.
Immediately following the Closing and assuming an Exchange Ratio of 0.5338 (which assumes both that Spring Banks valuation will not be adjusted as a result of its expected net cash at Closing and that F-star raises $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million), the holders of F-stars share capital (including all F-star shares issued in connection with the F-star Note Conversion, the F-star Share Conversion and Pre-Closing Financing) are expected to own over 60% of the outstanding capital stock of Spring Bank.
The Exchange Ratio is subject to adjustment and the respective ownership percentages for F-star and Spring Bank stockholders will change (i) to the extent that Spring Banks expected net cash as of Closing is less than $15.0 million or greater than $17.0 million, (ii) to the extent that F-star does not raise at least $25.0 million in the Pre-Closing Financing at a pre-money valuation of at least $35.0 million, and (iii) to account for the actual proceeds raised in the Pre-Closing Financing. Should the Closing occur after September 30, 2020, the $15.0 million and $17.0 million thresholds will each be reduced by $250,000 on October 30, 2020 and on the last day of each 30-day period thereafter until the Closing occurs. These and other adjustments to the Exchange Ratio are described further in this prospectus/proxy statement.
Basis of Presentation
The accompanying unaudited pro forma condensed combined financial information was prepared in accordance with Article 11 of SEC Regulation S-X on a basis consistent with U.S. GAAP. The unaudited condensed combined pro forma financial position and results of operations of the combined companies is based upon the separate historical data of Spring Bank and F-star. F-stars historical financial statements were prepared under IFRS as issued by the International Accounting Standards Board and converted to U.S. GAAP. For purposes of the unaudited pro forma condensed combined financial statements, F-stars presentation currency has been converted to U.S. dollars and F-stars statement of operations for the year ended December 31, 2019 has been presented on a combined basis with predecessor entities.
The accompanying unaudited pro forma condensed combined balance sheet as of June 30, 2020 is presented as if the Exchange had been completed on June 30, 2020. The unaudited pro forma condensed combined statement of operations for the six months ended June 30, 2020 and for the year ended December 31, 2019 gives effect to the Exchange as if it took place as of January 1, 2019, and were prepared using the historical results of Spring Bank and F-star for the six months ended June 30, 2020, and for the year ended December 31, 2019, respectively.
Accounting Policies
During the preparation of the accompanying unaudited pro forma condensed combined financial information, management did not identify any material differences between Spring Banks accounting policies and the accounting policies of F-star. See Note 5 for a discussion of the adjustments necessary to convert F-star financial statements from IFRS to U.S. GAAP.
2. |
Accounting for the Exchange |
The management of Spring Bank and F-star has preliminarily concluded that the Exchange represents a business combination pursuant to Financial Accounting Standards Board Accounting Standards Codification
374
Topic 805, Business Combinations (ASC 805). For accounting purposes, (i) F-star has been determined to be the accounting acquirer based upon the terms of the Exchange and other factors including: (x) F-stars security holders are expected to own over 60% of the combined company immediately following the closing of the Exchange, (y) F-star directors will hold a majority board seats in the combined company, and (z) F-star management will hold all key positions in the management of the combined company, and (ii) the Exchange will be accounted for as a reverse acquisition using the acquisition method of accounting for business combinations under the guidance of ASC 805. Accordingly, F-star will record the acquired assets and liabilities of Spring Bank at their fair value as of the Exchange closing date.
Management has estimated the preliminary purchase price and not yet completed an external valuation analysis of the fair value of Spring Banks assets to be acquired and liabilities to be assumed. As a result, management has estimated the allocation of the preliminary purchase price to Spring Banks assets and liabilities. This preliminary purchase price allocation has been used to prepare the pro forma adjustments in the unaudited pro forma condensed combined balance sheet. The final purchase price allocation will be determined when the final purchase price has been determined, the final assets and liabilities and any asset sales are known, and detailed valuations and any other studies and calculations deemed necessary have been completed. The final purchase price and purchase price allocation could differ materially from the preliminary purchase price and purchase price allocation used to prepare the pro forma adjustments resulting from changes to assets and liabilities and to the ultimate purchase consideration, and operations during the intervening period to the closing of the Exchange, among other factors.
The preliminary purchase price, or the proportional value to be retained by the Spring Bank stockholders and the holders of its common stock equivalents, has been based on the last reported sale price of Spring Bank common stock on The Nasdaq Capital Market on August 21, 2020. This preliminary purchase price is based on the aggregate number of shares of Spring Banks common stock and common stock equivalents expected to be outstanding, giving consideration to in-the-money share options and warrants, at the closing, of the Exchange as summarized below (in millions, except share and per share amounts):
Estimated number of shares to be owned by Spring Bank stockholders |
17,864,680 | |||
Multiplied by the fair value per share of Spring Bank common stock |
$ | 1.39 | ||
|
|
|||
Value of common stock |
24.8 | |||
Contingent value rights |
0.2 | |||
|
|
|||
Estimated purchase price |
$ | 25.0 | ||
|
|
The actual purchase price will fluctuate until the Closing and the final valuation could differ significantly from the preliminary estimate. The following table illustrates the effect of changes in the price of Spring Bank common stock on the estimated purchase price and on goodwill or the estimated bargain purchase gain than may result at certain purchase price levels in the Exchange (in millions, except per share amounts):
Spring
Bank Stock Price |
Purchase
Price |
Goodwill/
(Bargain Purchase Gain) |
||||||||||
Increase of 10% |
$ | 1.53 | $ | 27.5 | $ | 3.9 | ||||||
Increase of 20% |
$ | 1.67 | $ | 30.0 | $ | 6.4 | ||||||
Increase of 30% |
$ | 1.81 | $ | 32.5 | $ | 8.9 | ||||||
Decrease of 10% |
$ | 1.25 | $ | 22.5 | $ | (1.1 | ) | |||||
Decrease of 20% |
$ | 1.11 | $ | 20.1 | $ | (3.5 | ) | |||||
Decrease of 30% |
$ | 0.97 | $ | 17.6 | $ | (6.0 | ) |
Any excess of the purchase price over the estimated fair value of the net assets acquired will be recorded as goodwill on the balance sheet. Any excess of the estimated fair value of the net assets acquired over the purchase price paid will be recorded as a bargain purchase gain in the statement of operations.
375
The net tangible and intangible assets acquired and liabilities assumed in connection with the Exchange are recorded at their estimated acquisition date fair values with the excess going to goodwill. A final determination of these estimated fair values will be based on the estimated net tangible and intangible assets and liabilities of Spring Bank that exist as of the date of completion of the Exchange. The following summarizes a preliminary allocation of the estimated purchase price as if the Exchange had been completed on June 30, 2020 (in millions):
Cash and cash equivalents |
$ | 8.5 | ||
Marketable securities |
15.0 | |||
Prepaid expenses and other assets |
3.0 | |||
Property and equipment |
1.5 | |||
Operating lease right of use asset |
2.7 | |||
Intangible assets |
1.0 | |||
Accounts payable, accrued expenses and other liabilities |
(4.8 | ) | ||
Other long-term liabilities |
(0.2 | ) | ||
Operating lease liability |
(3.1 | ) | ||
|
|
|||
Net assets acquired |
23.6 | |||
Less: preliminary purchase price |
25.0 | |||
|
|
|||
Goodwill |
$ | 1.4 | ||
|
|
The allocation of the estimated purchase price is preliminary because the proposed Exchange has not yet been completed. The purchase price will remain preliminary until the Closing. The purchase price allocation will also remain preliminary until the final assets and liabilities existing at closing are determined and detailed valuations and any other studies and calculations deemed necessary have been completed. The final determination of the purchase price allocation is anticipated to be completed as soon as practicable after completion of the Exchange and will be based on the fair values of the assets acquired and liabilities assumed as of the closing date of the Exchange. The final amounts allocated to assets acquired and liabilities assumed could differ significantly from the amounts presented in the unaudited pro forma condensed combined financial statements.
Note 3 |
Pro Forma Adjustments |
The unaudited pro forma condensed combined financial statements include pro forma adjustments that are (i) directly attributable to the Exchange, (ii) factually supportable, and (ii) with respect to the unaudited pro forma condensed combined statements of operations, expected to have a continuing impact on the results of operations of the company. The unaudited pro forma condensed combined financial information does not give effect to the proposed reverse stock split of Spring Bank common stock, which is anticipated to occur immediately prior to the Closing, described elsewhere in this proxy statement/prospectus.
The pro forma adjustments, based on preliminary estimates that may change significantly as additional information is obtained, are as follows:
A. |
Concurrently with the execution of the Exchange Agreement, certain existing investors of F-star, pursuant to binding equity commitment letters by and between each investor and F-star, agreed to subscribe in a private placement of securities of F-star as of immediately prior to the Closing (the Pre-Closing Financing). This adjustment reflects an expected $25 million in net proceeds from the Pre-Closing Financing. |
B. |
Pursuant to the terms of the Exchange Agreement and immediately prior to the Closing, all issued and outstanding F-star convertible promissory notes will convert into F-star ordinary shares (the F-star Note Conversion). This adjustment reflects conversion of F-star Convertible Notes into Series A preference shares which will in turn be converted into ordinary F-star shares immediately prior to the closing of the Exchange. F-star has elected the fair value option for this instrument and the impact of changes in fair value is reflected in historic earnings. For purposes of the pro forma statement of operations, it is assumed that conversion to equity took place on January 1, 2019 and amounts recorded to earnings related to marking this instrument to fair value and interest expense have been reversed. |
376
C. |
To reflect estimated fair values of Spring Bank assets acquired and liabilities assumed, including recognition of an indefinite-lived intangible asset for in-process research and development. This intangible asset would only be amortized over the respective estimated useful lives of any products that receive appropriate regulatory approvals, if any. Until such time it will be subject to impairment testing. Property, plant and equipment acquired from Spring Bank is expected to be sold shortly after completion of the Exchange and is recorded at estimated fair value less cost to sell. Additionally, a positive adjustment of $0.5 million to align the lease right of use asset and liability has been offset by a negative adjustment of $0.4 million to reflect the fact that Spring Banks lease for its headquarters and research facility, which F-star intends to sublease, is off-market. The right of use asset related to the lease will be amortized over the remaining lease term of seven years. Also, a liability of $0.2 million has been recognized for the estimated fair value of the CVRs provided to Spring Bank shareholders. The estimate of fair value of the CVR is very preliminary, relies significantly on information which is available in the public domain and given the uncertainties inherent this preliminary estimate is highly subject to change as more complete information is obtained. The change in fair value of the CVRs will be updated each reporting period. The Company currently does not have a basis to evaluate the potential impact on earnings prospectively. The related deferred tax effect of these adjustments has also been recognized. |
D. |
Represents an adjustment to record goodwill resulting from the Exchange. Goodwill represents the excess of the preliminary estimated purchase price over the estimated fair value of Spring Bank identified net assets. |
E. |
To reflect the accrued liabilities that are assumed by F-star of approximately $2.2 million in severance cost payable to Spring Bank officers, $4.3 million for estimated transaction costs directly attributable to the closing of the Exchange. The $4.3 million in transaction costs includes the following costs to be incurred by Spring Bank: $1.0 million for investment banking services, and $0.8 million in legal, accounting and other expenses; and the following are transaction costs to be incurred by F-star: $2.5 million in legal, accounting and other expenses. These pro forma transaction costs are not reflected in the unaudited pro forma condensed combined statements of operations as these amounts are not expected to have a continuing effect on the operating results of the combined company. |
F. |
To reflect (1) the elimination of Spring Banks historical stockholders equity and (2) the issuance of Spring Bank common shares in exchange for F-stars ordinary shares to finance the acquisition. |
G. |
Reflects the pro forma weighted average shares outstanding, including the issuance of common shares to effect the Exchange, without giving effect to the proposed reverse stock split. Shares issued to finance the transaction assumes that immediately prior to the closing of the exchange that all of the issued and outstanding Seed Preference Shares and Series A Preference Shares of F-star will convert into approximately 1.5 million ordinary shares of F-star, and all outstanding F-star convertible loan notes will convert into 12.6 million ordinary shares of F-star. Shares issued to finance the transaction also assumes the completion of the Pre-Closing Financing, described in A above, which will result in the issuance of approximately 16.8 million ordinary shares of F-star. |
Note 4 |
Conversion of Reporting Currency for F-star Entities |
The financial statements of F-star were originally prepared in British Pounds Sterling (GBP). For purposes of the pro forma financial statements, all amounts in the June 30, 2020 balance sheet was converted to U.S. Dollars (USD) using a published exchange rate of 1.23 GBP per USD at that date. All statement of operations amounts for the six months ended June 30, 2020 and the year ended December 31, 2019 were converted to USD using the average exchanges rates for the periods of 1.26 GBP per USD and 1.28 GBP per USD, respectively. The statements of operations of Beta and GmbH for the period January 1, 2019 to May 6, 2019, see Note 6, have been converted from GBP to USD using an average rate for the period of 1.3 GBP per USD, and from Euro to USD using an average rate of 1.13 per USD, respectively
Note 5 |
Combination of F-star Entities |
On May 7, 2019, F-star completed a corporate reorganization pursuant to which F-star became the direct holding company of each of F-star Delta Ltd (Delta), F-star Beta Ltd (Beta), F-star Biotechnologische
377
Forschungs-und Entwicklungsges, m.b.H. (GmbH), and F-star Alpha Ltd (Alpha) and the indirect holding company of each of F-star Biotechnology Limited (Biotech), and F-star Therapeutics LLC (LLC) (collectively, the F-star Group Entities). Prior to the transactions described below, all F-star Group entities were deemed to be related parties due to common directorships.
Exchange of Delta Shares for F-star Shares (capital reorganization)
All shareholders of Delta exchanged each of the shares held by them in Delta for the same class and number of newly issued shares of F-star and, as a result, Delta became a wholly owned subsidiary of F-star. The number of shares issued was 9,053,538 at a ratio of 1:1. This was accounted for as Delta obtaining a controlling interest in F-star using reverse acquisition accounting principles.
F-star, the legal acquirer of Delta and the other F-star Group Entities (see below), is an entity with no historical operations and was created solely for the purpose of effecting the corporate reorganization. Accordingly, for accounting purposes, it was not deemed substantive nor the accounting acquirer of the F-star Group Entities. The effect of using reverse acquisition accounting is that the historical (prior to the date of acquisition) financial statements of F-star reflect the operations and historical financial position and financial performance of legal subsidiary Delta (the accounting acquirer).
Exchange of GmbH, Beta and Alpha Shares for F-star Shares (business combination and asset acquisition)
Effective as of the date of and subsequent to the Delta share exchange, all shareholders of each of Alpha, Beta and GmbH exchanged each of the shares held in Alpha, Beta and GmbH for newly issued shares in F-star. As a result, Alpha, Beta and GmbH became wholly owned subsidiaries of F-star. Holders of options to purchase shares of Alpha, Beta and GmbH swapped their existing options for new options to purchase shares of F-star.
GmbH and Beta were deemed to meet the definition of a business in accordance with IFRS 3 Business Combinations. The acquisition of GmbH and Beta was accounted for a business combination, and the acquisition of a controlling interest in Alpha was accounted for as an asset acquisition. No other assets, including cash, were transferred or liabilities assumed as consideration for the corporate reorganization. The transaction price was measured as the fair value of equity issued in accordance with IFRS 3 Business Combinations.
The below unaudited pro forma condensed combined statement of operations for the year ended December 31, 2019 gives effect to the Exchange as if it took place as of January 1, 2019, and was prepared using the historical results of F-star for the year ended December 31, 2019, and the historical results for Beta and GmbH for the period from January 1, 2019 to May 6, 2019. The effect of transactions between the entities during the period January 1 2019 to May 6, 2019 have been eliminated as though the companies were part of a consolidated group.
378
Unaudited Pro Forma Condensed Combined Statement of Operations of F-star Group Entities
For the Year Ended December 31, 2019
(in millions)
Historical U.S.Dollar 2019 | ||||||||||||||||||||
F-star
(Year Ended Dec. 31) |
GmbH
(Period Ended May 6) |
Beta
(Period Ended May 6) |
Eliminations |
F-Star
Reorganization Combined |
||||||||||||||||
Revenue |
$ | 27.9 | $ | 10.3 | $ | 10.3 | $ | (18.6 | ) | $ | 29.9 | |||||||||
Operating Expenses: |
||||||||||||||||||||
Costs related to collaborative arrangements |
22.8 | 1.6 | 2.5 | (6.9 | ) | 20.0 | ||||||||||||||
Research and development |
41.7 | 3.4 | 6.6 | (1.0 | ) | 50.7 | ||||||||||||||
General and administrative |
15.7 | 4.4 | 1.2 | 21.3 | ||||||||||||||||
Other operating (income) expense, net |
(0.5 | ) | (0.8 | ) | | (1.3 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total operating expenses |
79.8 | 8.6 | 10.3 | (7.9 | ) | 90.8 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Loss from operations |
(51.8 | ) | 1.6 | | (10.7 | ) | (60.9 | ) | ||||||||||||
Interest income (expense), net |
(0.3 | ) | | (0.1 | ) | (0.4 | ) | |||||||||||||
Change in fair value of liabilities |
(1.4 | ) | | | (1.4 | ) | ||||||||||||||
Other non-operating income (expense), net |
(0.1 | ) | | | (0.1 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Loss before tax |
(53.6 | ) | 1.6 | (0.1 | ) | (10.7 | ) | (62.8 | ) | |||||||||||
Income tax benefit (expense) |
8.9 | | 0.8 | | 9.7 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (44.7 | ) | $ | 1.6 | $ | 0.7 | $ | (10.7 | ) | $ | (53.1 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
The GmbH audited financial statements, included in this proxy/registration statement, for the period January 1, 2019 to May 6, 2019 present operating expenses by their nature. A reconciliation of the amounts presented in the audited financial statements, converted to U.S. dollars see Note 4, to the amounts above by function is provided below.
Allocation by Function | ||||||||||||||||
Expense by
Nature (per Audited Financial Statements) |
Costs Related
to Collaborative Arrangements |
Research and
Development |
General and
Administrative |
|||||||||||||
Raw materials and consumables used |
$ | 1.5 | $ | | $ | 1.5 | $ | | ||||||||
Depreciation, amortization and loss on disposals |
0.6 | | 0.3 | 0.3 | ||||||||||||
Employee expenses |
3.8 | 1.6 | 0.6 | 1.6 | ||||||||||||
Other expenses |
3.5 | | 1.0 | 2.5 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 9.4 | $ | 1.6 | $ | 3.4 | $ | 4.4 | ||||||||
|
|
|
|
|
|
|
|
Note 6 |
Conversion of F-star from IFRS to U.S. GAAP |
The financial statements of F-star were originally prepared in accordance IFRS as issued by the IASB. In the preparation of the unaudited pro forma condensed combined financial statements, a number of adjustments were made, as described below and shown in the accompanying reconciliation tables, to align the F-star financial statements with the different requirements of U.S. GAAP. F-star will adopt U.S. GAAP following the completion of the transaction and is expected to adopt new accounting standards on a timeline consistent with the requirements for public entities.
V. |
Intangible assets have been adjusted by a net $29.2 million ($22.2 million increase for reversal of amortization and impairment see Y below followed by a $51.5 million reduction) to remove in-process research and development intangible assets acquired outside of a business combination that would not be eligible for capitalization under U.S. GAAP. Related to this adjustment, associated deferred tax liabilities have also been removed and shareholders equity has been adjusted accordingly. |
379
Note that a significant amount of the equity impact has been reflected in additional paid in capital as the capitalized intangibles relate to a pre F-star reorganization settlement of transaction between group entities, the effect of which was booked directly to additional paid in capital under IFRS. |
W. |
Goodwill has been increased and accumulated deficit has been decreased by $0.4 million to reverse the effect of an impairment charge that would not have been required under U.S. GAAP because under U.S. GAAP the F-star business would be considered a single reporting unit for purposes of goodwill impairment testing, while IFRS required testing at a more granular level with multiple cash generating units. The related income statement impact of the impairment reversal has been included in the 2019 as a reduction of research and development expense. |
X. |
Amounts classified as costs related to collaborative arrangements have been reclassified to research and development expense to conform to the typical presentation of collaboration costs by peer companies reporting under U.S. GAAP. |
Y. |
Research and development expense, as adjusted to reflect the above reclassification, has been reduced by $17.2 million for the year ended December 31, 2019 and $0.7 million for the six months ended June 30, 2020 to remove amortization and impairment costs related to the purchased in-process research and development that would not have been capitalized under U.S. GAAP. Adjustment has also been made for the related income tax effects, reducing the income tax benefit by $1.4 million and $0.4 million for the year ended December 31, 2019 and the six months ended June 30, 2020, respectively. Note that no adjustment was made to increase research and development expense for purchased in-process research and development as the capitalized amounts related to transactions outside of the periods covered by the income statements presented. |
Z. |
Income tax benefit and research and development expense have been decreased to reclassify refundable tax credits of $5.1 million and $3.4 million for the year ended December 31, 2019 and the six months ended June 30, 2020, respectively, that are presented in the income tax line under IFRS, but are not considered to be an element of income tax accounting under U.S. GAAP. |
380
F-Star
IFRS |
Adjustments |
F-star
GAAP Adjusted |
Notes | |||||||||||||
Assets |
||||||||||||||||
Current assets |
||||||||||||||||
Cash and cash equivalents |
$ | 2.7 | $ | | $ | 2.7 | ||||||||||
Marketable securities |
| | | |||||||||||||
Trade and other receivables |
2.5 | | 2.5 | |||||||||||||
Prepaid expenses and other current assets |
4.2 | | 4.2 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total current assets |
9.4 | | 9.4 | |||||||||||||
Property and equipment, net |
1.0 | | 1.0 | |||||||||||||
Lease right of use assets |
0.2 | | 0.2 | |||||||||||||
Intangible assets, net |
41.3 | (29.2 | ) | 12.1 | V, Y | |||||||||||
Other assets |
0.1 | | 0.1 | |||||||||||||
Goodwill |
3.5 | 0.4 | 3.9 | W | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total assets |
$ | 55.5 | $ | (28.8 | ) | $ | 26.7 | |||||||||
|
|
|
|
|
|
|||||||||||
Liabilities and Stockholders Equity |
|
|||||||||||||||
Current liabilities: |
||||||||||||||||
Accounts payable |
$ | 12.3 | $ | | $ | 12.3 | ||||||||||
Accrued expenses and other current liabilities |
0.6 | | 0.6 | |||||||||||||
Lease liability |
0.2 | | 0.2 | |||||||||||||
Convertible notes |
17.8 | | 17.8 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total current liabilities |
30.8 | | 30.8 | |||||||||||||
Non-current liabilities: |
||||||||||||||||
Lease liability, noncurrent |
| | | |||||||||||||
Other long-term liabilities |
1.6 | (1.6 | ) | | V | |||||||||||
|
|
|
|
|
|
|||||||||||
Total non-current liabilities |
1.6 | (1.6 | ) | | ||||||||||||
Stockholders equity: |
||||||||||||||||
Preferred Stock |
| | | |||||||||||||
Common Stock |
0.2 | | 0.2 | |||||||||||||
Additional paid-in capital |
55.9 | (29.1 | ) | 26.8 | V | |||||||||||
Accumulated other comprehensive income |
| | | |||||||||||||
Accumulated deficit |
(33.1 | ) | 1.9 | (31.2 | ) | V, W | ||||||||||
|
|
|
|
|
|
|||||||||||
Total stockholders equity (deficit) |
23.0 | (27.2 | ) | (4.2 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Total liabilities and stockholders equity |
$ | 55.5 | $ | (28.8 | ) | $ | 26.7 | |||||||||
|
|
|
|
|
|
381
Statement of Operations for the Six Months Ended June 30, 2020
F-Star
IFRS |
Adjustments |
F-star
GAAP Adjusted |
Notes | |||||||||||||
Revenue |
$ | 1.9 | $ | | $ | 1.9 | ||||||||||
Operating Expenses: |
||||||||||||||||
Cost related to collaborative arrangements |
0.4 | (0.4 | ) | | X | |||||||||||
Research and development |
9.3 | (3.4 | ) | 5.9 | W, X, Y, Z | |||||||||||
General and administrative |
6.3 | | 6.3 | |||||||||||||
Other operating (income) expense, net |
1.2 | | 1.2 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total operating expenses |
17.2 | (3.8 | ) | 13.4 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Loss from operations |
(15.3 | ) | | (11.5 | ) | |||||||||||
Interest income (expense), net |
(0.5 | ) | | (0.5 | ) | |||||||||||
Change in fair value of liabilities |
(1.9 | ) | | (1.9 | ) | |||||||||||
Other non-operating income (expense), net |
| | | |||||||||||||
|
|
|
|
|
|
|||||||||||
Loss before tax |
(17.7 | ) | (3.8 | ) | (13.9 | ) | ||||||||||
Income tax benefit (expense) |
3.4 | 3.4 | | Y, Z | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (14.3 | ) | $ | (0.4 | ) | $ | (13.9 | ) | |||||||
|
|
|
|
|
|
382
Statement of Operations for the Year Ended December 31, 2019
F-Star
Combined IFRS (1) |
Adjustments |
F-Star
GAAP Adjusted |
Notes | |||||||||||||
Revenue |
$ | 29.9 | $ | | $ | 29.9 | ||||||||||
Operating Expenses: |
||||||||||||||||
Cost related to collaborative arrangements |
20.0 | (20.0 | ) | | X | |||||||||||
Research and development |
50.7 | (8.8 | ) | 41.9 | W, X, Y, Z | |||||||||||
General and administrative |
21.3 | 21.3 | ||||||||||||||
Other operating (income) expense, net |
(1.3 | ) | (1.3 | ) | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total operating expenses |
90.8 | (28.8 | ) | 61.9 | ||||||||||||
|
|
|
|
|||||||||||||
Loss from operations |
(60.9 | ) | (32.0 | ) | ||||||||||||
Interest income (expense), net |
(0.4 | ) | (0.4 | ) | ||||||||||||
Change in fair value of liabilities |
(1.5 | ) | (1.5 | ) | ||||||||||||
Other non-operating income (expense), net |
| | ||||||||||||||
|
|
|
|
|
|
|||||||||||
Loss before tax |
(62.8 | ) | (33.9 | ) | ||||||||||||
Income tax benefit (expense) |
9.7 | (8.2 | ) | 1.5 | Y, Z | |||||||||||
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (53.1 | ) | $ | 20.6 | $ | (32.5 | ) | ||||||||
|
|
|
|
|
|
(1) |
See Note 5 for discussion of the F-star reorganization and combination of F-star and predecessor entities. |
383
SRING BANK PHARMACEUTICALS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page | ||||
Audited Financial Statements | ||||
F-2 | ||||
Consolidated Financial Statements: |
||||
F-3 | ||||
Consolidated Statements of Operations and Comprehensive Loss |
F-4 | |||
F-5 | ||||
F-6 | ||||
F-7 |
Unaudited Interim Financial Statements
F-26 | ||||
Consolidated Statements of Operations and Comprehensive Loss |
F-27 | |||
F-28 | ||||
F-30 | ||||
F-31 |
F-1
SPRING BANK PHARMACEUTICALS, INC.
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of
Spring Bank Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Spring Bank Pharmaceuticals, Inc. and its subsidiaries (the Company) as of December 31, 2019 and 2018, the related consolidated statements of operations and comprehensive loss, changes in stockholders equity and cash flows for the years then ended, and the related notes to the consolidated financial statements (collectively, the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on the Companys financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Companys internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ RSM US LLP
We have served as the Companys auditor since 2013.
Boston, Massachusetts
February 14, 2020
F-2
SPRING BANK PHARMACEUTICALS, INC.
(In Thousands, Except Share and Per Share Data)
December 31, | ||||||||
2019 | 2018 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 28,709 | $ | 14,724 | ||||
Marketable securities |
25,746 | 32,914 | ||||||
Prepaid expenses and other current assets |
3,522 | 1,649 | ||||||
|
|
|
|
|||||
Total current assets |
57,977 | 49,287 | ||||||
Marketable securities, long-term |
| 16,804 | ||||||
Property and equipment, net |
2,234 | 2,319 | ||||||
Operating lease right-of-use assets |
2,717 | | ||||||
Restricted cash |
234 | 234 | ||||||
Other assets |
35 | 167 | ||||||
|
|
|
|
|||||
Total |
$ | 63,197 | $ | 68,811 | ||||
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,210 | $ | 1,880 | ||||
Accrued expenses and other current liabilities |
2,438 | 2,367 | ||||||
Accrued interest payable |
403 | | ||||||
Operating lease liabilities, current |
355 | | ||||||
|
|
|
|
|||||
Total current liabilities |
5,406 | 4,247 | ||||||
Convertible term loan, net of unamortized discount |
19,070 | | ||||||
Warrant liabilities |
299 | 8,511 | ||||||
Operating lease liabilities, noncurrent |
2,869 | | ||||||
Other long-term liabilities |
27 | 193 | ||||||
|
|
|
|
|||||
Total liabilities |
27,671 | 12,951 | ||||||
|
|
|
|
|||||
Commitments and contingencies (Note 12) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.0001 par valueauthorized, 10,000,000 shares at December 31, 2019 and 2018; no shares issued or outstanding at December 31, 2019 and 2018 |
| | ||||||
Common stock, $0.0001 par valueauthorized, 200,000,000 shares at December 31, 2019 and 2018; 16,513,763 and 16,434,614 shares issued and outstanding outstanding at December 31, 2019 and 2018, respectively |
2 | 2 | ||||||
Additional paid-in capital |
161,924 | 157,931 | ||||||
Accumulated deficit |
(126,165 | ) | (102,068 | ) | ||||
Accumulated other comprehensive loss |
(235 | ) | (5 | ) | ||||
|
|
|
|
|||||
Total stockholders equity |
35,526 | 55,860 | ||||||
|
|
|
|
|||||
Total |
$ | 63,197 | $ | 68,811 | ||||
|
|
|
|
See accompanying notes to consolidated financial statements.
F-3
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In Thousands, Except Share and Per Share Data)
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
Operating expenses: |
||||||||
Research and development |
$ | 23,270 | $ | 19,751 | ||||
General and administrative |
9,751 | 8,719 | ||||||
|
|
|
|
|||||
Total operating expenses |
33,021 | 28,470 | ||||||
|
|
|
|
|||||
Loss from operations |
(33,021 | ) | (28,470 | ) | ||||
Other income (expense): |
||||||||
Interest income |
1,254 | 999 | ||||||
Interest expense |
(542 | ) | | |||||
Change in fair value of warrant liabilities |
8,212 | 4,617 | ||||||
|
|
|
|
|||||
Net loss |
(24,097 | ) | (22,854 | ) | ||||
Unrealized gain (loss) on marketable securities |
(230 | ) | 18 | |||||
|
|
|
|
|||||
Comprehensive loss |
$ | (24,327 | ) | $ | (22,836 | ) | ||
|
|
|
|
|||||
Net loss per common share: |
||||||||
Basic |
$ | (1.46 | ) | $ | (1.59 | ) | ||
|
|
|
|
|||||
Diluted |
$ | (1.46 | ) | $ | (1.88 | ) | ||
|
|
|
|
|||||
Weighted-average number of shares outstanding: |
||||||||
Basic |
16,454,083 | 14,372,174 | ||||||
|
|
|
|
|||||
Diluted |
16,454,083 | 14,618,976 | ||||||
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY
(In Thousands, Except Share and Per Share Data)
Common Stock |
Additional
Paid-in Capital |
Accumulated
Deficit |
Other
Comprehensive Income (Loss) |
Total
Stockholders Equity |
||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2017 |
12,961,993 | $ | 1 | $ | 113,984 | $ | (79,214 | ) | $ | (23 | ) | $ | 34,748 | |||||||||||
Stock-based compensation |
| | 2,662 | | | 2,662 | ||||||||||||||||||
Issuance of common stock for services rendered |
9,213 | | 114 | | | 114 | ||||||||||||||||||
Issuance of common stock in connection with offering, net of issuance costs |
3,246,079 | 1 | 37,959 | | | 37,960 | ||||||||||||||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs |
217,329 | | 3,212 | | | 3,212 | ||||||||||||||||||
Net unrealized gain on marketable securities |
| | | | 18 | 18 | ||||||||||||||||||
Net loss |
| | | (22,854 | ) | | (22,854 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at December 31, 2018 |
16,434,614 | $ | 2 | $ | 157,931 | $ | (102,068 | ) | $ | (5 | ) | $ | 55,860 | |||||||||||
Stock-based compensation |
| | 3,130 | | | 3,130 | ||||||||||||||||||
Issuance of common stock for services rendered |
78,549 | | 261 | | | 261 | ||||||||||||||||||
Issuance of common stock in connection with at-the-market offering |
600 | | 6 | | | 6 | ||||||||||||||||||
Issuance of warrants in connection with term loan |
| | 552 | | | 552 | ||||||||||||||||||
Issuance of warrants to a service provider |
| | 19 | | | 19 | ||||||||||||||||||
Offering costs in connection with common stock offering |
| | 25 | | | 25 | ||||||||||||||||||
Net unrealized loss on marketable securities |
| | | | (230 | ) | (230 | ) | ||||||||||||||||
Net loss |
| | | (24,097 | ) | | (24,097 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at December 30, 2019 |
16,513,763 | $ | 2 | $ | 161,924 | $ | (126,165 | ) | $ | (235 | ) | $ | 35,526 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-5
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (24,097 | ) | $ | (22,854 | ) | ||
Adjustments for: |
||||||||
Depreciation and amortization |
357 | 288 | ||||||
Loss on disposal of property and equipment |
| 52 | ||||||
Operating lease right-of-use asset amortization |
263 | | ||||||
Change in fair value of warrant liabilities |
(8,212 | ) | (4,617 | ) | ||||
Non-cash interest expense |
86 | 337 | ||||||
Non-cash investment income |
(28 | ) | | |||||
Non-cash stock-based compensation |
3,367 | 2,776 | ||||||
Non-cash issuance of warrants to a service provider |
19 | | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(1,873 | ) | (1,069 | ) | ||||
Other assets |
132 | (132 | ) | |||||
Accounts payable |
330 | 180 | ||||||
Accrued expenses and other liabilities |
358 | (205 | ) | |||||
Accrued interest payable |
403 | | ||||||
Operating lease liabilities |
(160 | ) | | |||||
|
|
|
|
|||||
Net cash used in operating activities |
(29,055 | ) | (25,244 | ) | ||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Proceeds from sale of marketable securities |
38,770 | 34,869 | ||||||
Purchases of marketable securities |
(15,000 | ) | (58,000 | ) | ||||
Purchases of property and equipment |
(272 | ) | (1,972 | ) | ||||
|
|
|
|
|||||
Net cash provided by (used in) investing activities |
23,498 | (25,103 | ) | |||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Proceeds from term loan and warrants |
20,000 | | ||||||
Issuance costs in connection with term loan and warrants |
(464 | ) | | |||||
Proceeds from issuance of common stock, net of issuance costs |
| 37,960 | ||||||
Proceeds from issuance of common stock in connection with at-the-market offering, net of issuance costs |
6 | 3,212 | ||||||
|
|
|
|
|||||
Cash provided by financing activities |
19,542 | 41,172 | ||||||
|
|
|
|
|||||
Net increase (decrease) in cash, cash equivalents and restricted cash |
13,985 | (9,175 | ) | |||||
Cash, cash equivalents and restricted cash, beginning of period |
14,958 | 24,133 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash, end of period |
$ | 28,943 | $ | 14,958 | ||||
|
|
|
|
|||||
Supplemental disclosures of cash flow information: |
||||||||
Cash paid for taxes |
$ | 30 | $ | 3 | ||||
|
|
|
|
|||||
Cash paid for interest, net |
$ | 53 | $ | | ||||
|
|
|
|
See accompanying notes to consolidated financial statements.
F-6
Spring Bank Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
1. |
NATURE OF BUSINESS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Nature of Business
Spring Bank Pharmaceuticals, Inc. (the Company) is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of a range of cancers and inflammatory diseases using its proprietary small molecule nucleotide platform. The Company designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. The Companys internally-developed programs are primarily designed to stimulate and/or dampen immune responses. The Company is devoting its resources to advancing multiple programs in its STING (STimulator of INterferon Genes) product portfolio.
Until recently, the Company was focused on developing inarigivir for the treatment of chronic hepatitis B virus, or HBV. Inarigivir was being evaluated in multiple clinical trials, including the Companys Phase 2b CATALYST trials, designed to evaluate both treatment-naïve and virally-suppressed non-cirrhotic patients with HBV under multiple dosing regimens. In January 2020, the Company announced the discontinuation of the development of inarigivir based on an ongoing assessment of patients in its Phase 2b CATALYST trials.
Since its inception in 2002 and prior to its initial public offering (IPO) in May 2016, the Company built its technology platform and product candidate pipeline, supported by grants and through private financings. The Company has three wholly owned subsidiaries: Sperovie Biosciences, Inc. formed in September 2015, SBP Securities Corporation formed in December 2016 and SBP International Limited formed in May 2019.
The Companys success is dependent upon its ability to successfully complete clinical development and obtain regulatory approval of its product candidates, successfully commercialize approved products, generate revenue, and, ultimately, attain profitable operations.
Basis of Presentation and Liquidity
The accompanying consolidated financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP).
As of December 31, 2019, the Company had an accumulated deficit of $126.2 million and $54.5 million in cash, cash equivalents and marketable securities.
The Company expects to continue to incur significant and increasing losses for the foreseeable future. The Company anticipates that its expenses will increase significantly as it continues to develop SB 11285 and its other product candidates. The Company does not have any committed external source of funds. As a result, the Company will need additional financing to support its continuing operations. Adequate additional funds may not be available to the Company on acceptable terms, or at all. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, stockholders ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect common stockholder rights. If the Company raises additional funds through collaborations, strategic alliances or licensing arrangements with third parties, the Company may have to relinquish valuable rights to its technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to the Company.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Sperovie Biosciences, Inc., SBP Securities Corporation and SBP International Limited. Sperovie Biosciences, Inc. had operations consisting mainly of legal fees associated with intellectual property activities as of December 31, 2019. Sperovie Biosciences, Inc. is a joint borrower with the Company under the Companys term
F-7
loan (see Note 9). SBP Securities Corporation had assets primarily related to investments in marketable securities and operations consisting primarily of interest income as of December 31, 2019. SBP International Limited had operations consisting mainly of clinical trial oversight, including European data protection oversight, as of December 31, 2019. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates relied upon in preparing the accompanying financial statements related to the fair value of warrant liabilities, accounting for stock-based compensation, income taxes, useful lives of long-lived assets, and accounting for certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis. The Companys actual results may differ from these estimates.
Cash and Cash Equivalents
Cash equivalents are stated at fair value and include short-term, highly liquid investments with remaining maturities of 90 days or less at the date of purchase. Included in cash and cash equivalents as of December 31, 2019 are money market fund investments of $21.1 million and United States treasury securities of $6.0 million, which are reported at fair value. As of December 31, 2018, included in cash and cash equivalents are money market fund investments of $13.3 million, which are reported at fair value (Note 5).
Restricted Cash
As of December 31, 2019 and 2018, restricted cash consisted of approximately $234,000, which is held as a security deposit required in conjunction with the lease agreement for the Companys principal office and laboratory space entered into in October 2017.
Concentration of Credit Risk
Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable securities. Substantially all of the Companys cash is held at financial institutions that management believes to be of high-credit quality. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits; however, these deposits may be redeemed upon demand and, therefore, bear minimal risk.
Investments in Marketable Securities
The Company invests excess cash balances in short-term and long-term marketable securities. The Company classifies investments in marketable securities as either held-to-maturity or available-for-sale based on facts and circumstances present at the time of purchase. At each balance sheet date presented, all investments in securities are classified as available-for-sale. The Company reports available-for-sale investments at fair value at each balance sheet date and includes any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of stockholders equity. Realized gains and losses are determined using the specific identification method and are included in other income (expense). If any adjustment to fair value reflects a decline in the value of the investment, the Company considers all available evidence to evaluate the extent to which the decline is other than temporary, including the intention to sell and, if so, marks the investment to market through a charge to the Companys consolidated statements of operations and comprehensive loss.
F-8
Property and Equipment, Net
Property and equipment are recorded at cost. Costs associated with maintenance and repairs are expensed as incurred. Depreciation and amortization are provided using the straight-line method over the estimated useful lives:
Asset Category |
Useful Life |
|
Equipment | 5-7 years | |
Furniture and fixtures | 5 years | |
Leasehold improvements |
Lesser of 10 years or the remaining term of the respective lease |
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (ROU) assets, other current liabilities and operating lease liabilities in the Companys consolidated balance sheets.
ROU assets represent the Companys right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date of a lease based on the present value of lease payments over the lease term. As the Companys leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset also includes any lease payments made and excludes lease incentive amounts. The Companys lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
Impairment of Long-Lived Assets
Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, an impairment loss is recorded for the difference between the carrying value and fair value of the asset. Through December 31, 2019, no such impairment has occurred.
Research and Development Costs
Research and development expenses consist primarily of costs incurred for the Companys research activities, including discovery efforts, and the development of product candidates, which include:
|
expenses incurred under agreements with third parties, including contract research organizations, or CROs, that conduct research, preclinical activities and clinical trials on the Companys behalf as well as contract manufacturing organizations, or CMOs, that manufacture drug products for use in the Companys preclinical and clinical trials; |
|
salaries, benefits and other related costs, including stock-based compensation expense, for personnel in the Companys research and development functions; |
|
costs of outside consultants, including their fees, stock-based compensation and related travel expenses; |
|
the cost of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials; |
|
costs related to compliance with regulatory requirements; and |
|
facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. |
F-9
The Company expenses research and development costs as incurred. The Company recognizes external development costs based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors and its clinical investigative sites. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in the Companys consolidated financial statements as prepaid or accrued research and development expenses.
Warrants
The Company accounts for freestanding warrants within stockholders equity or as liabilities based on the characteristics and provisions of each instrument. The Company evaluates outstanding warrants in accordance with ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. If none of the criteria in the evaluation in these standards are met, the warrants are classified as a component of stockholders equity and initially recorded at their grant date fair value without subsequent remeasurement. Warrants that meet the criteria are classified as liabilities and remeasured to their fair value at the end of each reporting period.
Stock-Based Compensation
The Companys stock-based payments include stock options, performance-based restricted stock units (RSUs) and grants of common stock, including common stock subject to vesting. The Company accounts for all stock-based payment awards granted to employees and nonemployees using a fair value method. The measurement date for employee awards is the date of grant, and stock-based compensation costs are recognized as expense over the employees requisite service period, which is generally the vesting period, on a straight-line basis. The Company accounts for forfeitures as they occur.
The Company measures the fair value of the performance-based RSUs relating to the total share return performance using a Monte Carlo valuation model. The Company measures the fair value of the performance-based RSUs relating to the milestone performance goals using the fair value method and the probability that the specified performance criteria will be met. Each quarter the Company updates its assessment of the probability that the specified milestone criteria will be achieved and adjusts its estimate of the fair value, if necessary. Stock-based compensation expense is classified in the accompanying consolidated statements of operations and comprehensive loss based on the department to which the related services are provided.
Financial Instruments
The Companys financial instruments consist of cash equivalents, marketable securities, accounts payable, a term loan and liability classified warrants. The carrying amounts of cash and cash equivalents and accounts payable approximate their fair value due to the short-term nature of those financial instruments. The fair value of the marketable securities and liability classified warrants are remeasured to fair value each reporting period (see Note 5). The fair value of the term loan approximates its face value due to market terms.
Fair Value Measurements
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Accounting Standards Codification 820, Fair Value Measurements and Disclosures (ASC 820), establishes a hierarchy of inputs used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Companys assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:
Level 1 Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2 Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
F-10
Level 3 Valuations that require inputs that reflect the Companys own assumptions that are both significant to the fair value measurement and unobservable.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instruments level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Companys assets and liabilities measured at fair value on a recurring basis include cash equivalents, marketable securities and warrant liabilities.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period, determined using the treasury-stock method and the as if-converted method, for convertible securities, if inclusion of these instruments is dilutive.
For the year ended December 31, 2019, both methods are equivalent. For the year ended December 31, 2018, diluted net loss per share amounts were calculated based on the dilutive effect of the total number of shares of common stock related to the November 2016 Private Placement warrants and the change in the fair value of the warrant liability. Basic and diluted net loss per share are described further in Note 2.
Income Taxes
Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax basis of existing assets and liabilities as well as net operating loss and tax credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
The Company assesses its income tax positions and records tax benefits based upon managements evaluation of the facts, circumstances, and information available at the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50% likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, no tax benefit is recognized in the consolidated financial statements. The Company classifies interest and penalties associated with such uncertain tax positions as a component of tax expense. As of December 31, 2019 and 2018, the Company has not identified any material uncertain tax positions.
Guarantees and Indemnifications
As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Companys request in such capacity.
The Company leases office and laboratory space in Hopkinton, Massachusetts and previously leased research and development space in Milford, Massachusetts under non-cancelable operating leases. The Company has standard indemnification arrangements under these leases that require it to indemnify the landlords against liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or nonperformance under the Companys lease.
Through December 31, 2019, the Company had not experienced any losses related to these indemnification obligations and no material claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.
F-11
Segment Information
Operating segments are identified as components of an enterprise about which separate and discrete financial information is available for evaluation by the chief operating decision maker, the Companys Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment and does not track expenses on a program-by-program basis.
Recently Issued Accounting Pronouncements
In February 2016, the FASB issued ASU No. 2016-02, Leases (ASU 2016-02). ASU 2016-02 requires lessees to recognize most leases on their balance sheet as a right-of-use asset and a lease liability. Leases are classified as either operating or finance, and classification is based on criteria similar to current lease accounting, but without explicit bright lines. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases (ASU 2018-10), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No. 2018-11, Leases (Topic 842) Targeted Improvements (ASU 2018-11), which addresses implementation issues related to the new lease standard. The guidance is effective for annual reporting periods beginning after December 15, 2018 and interim periods within those fiscal years, and early adoption is permitted. Under this standard, disclosures are required to enable users of financial statements in assessing the amount, timing, and uncertainty of cash flows arising from leases. The standard permits two transition methods, (1) to apply the new lease requirements at the beginning of the earliest period presented, or (2) to apply the new lease requirements at the effective date.
The Company adopted the standard on the effective date of January 1, 2019 by applying the new lease requirements at the effective date. Prior periods continue to be presented based on the accounting standards originally in effect for such periods. The Company also elected the package of practical expedients permitted under the transition guidance within the new standard, which, among other things, allows the Company to carry forward the historical lease classification. The Company will also apply the practical expedient not to separate lease and non-lease components for new and modified leases commencing after adoption. The standard had an impact of approximately $3.0 million on the Companys assets and $3.4 million on its liabilities, as of January 1, 2019, for the recognition of right-of-use assets and lease liabilities, which are primarily related to the lease of its corporate headquarters in Hopkinton, Massachusetts. The standard did not have a material impact on the Companys results of operations or liquidity (see Note 10).
In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred stock that contain down round features. Part II simply replaces the indefinite deferral for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities contained within Accounting Standards Codification (ASC) Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. This ASU is effective for public companies for the annual reporting periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted. The Company adopted this standard as of January 1, 2019; however, the adoption of this standard did not impact the Companys consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework Changes to the Disclosure Requirement for Fair Value Measurement. This ASU removes, modifies and adds certain disclosure requirements of ASC Topic 820. The ASU is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company is currently evaluating the impact that the adoption of this standard may have on the Companys consolidated financial statements.
F-12
2. |
NET LOSS PER SHARE |
The following table summarizes the computation of basic and diluted net loss per share of the Company for the years ended December 31, 2019 and 2018 (in thousands, except share and per share data):
Year Ended December 31, |
||||
2019 | ||||
Net loss |
$ | (24,097 | ) | |
Weighted-average number of shares outstanding - basic and diluted |
16,454,083 | |||
Net loss per common share - basic and diluted |
$ | (1.46 | ) |
For the year ended December 31, 2019, the diluted net loss per common share is the same as basic net loss per common share.
Year Ended December 31, |
||||
2018 | ||||
Net loss |
$ | (22,854 | ) | |
Less: decrease in change in fair value of warrant liabilities |
(4,617 | ) | ||
|
|
|||
Net loss available to common shareholders |
$ | (27,471 | ) | |
|
|
|||
Weighted-average number of shares outstanding: |
||||
Basic |
14,372,174 | |||
Effect of dilutive securities: |
||||
Common stock warrants |
246,802 | |||
|
|
|||
Dilutive potential common shares |
14,618,976 | |||
|
|
|||
Net loss per common share: |
||||
Basic |
$ | (1.59 | ) | |
|
|
|||
Diluted |
$ | (1.88 | ) | |
|
|
For the year ended December 31, 2018, the diluted net loss per common share amounts under the treasury stock method was calculated based on the dilutive effect of the total number of shares of common stock related to the November 2016 Private Placement Warrants of 1,633,777 shares with an exercise price of $10.79. For the period ended December 31, 2018, the average stock price was $12.71, providing 246,802 dilutive shares for the November 2016 Private Placement Warrants. The change in the fair value of the warrant liability of $4.6 million is included in the net loss available to common shareholders for the diluted net loss per common share amount.
The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact due to the losses reported:
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
Convertible debt |
2,329,143 | | ||||||
Common stock warrants |
1,927,124 | 28,347 | ||||||
Stock options |
1,901,665 | 1,349,565 |
3. |
INVESTMENTS |
Cash in excess of the Companys immediate requirements is invested in accordance with the Companys investment policy that primarily seeks to maintain adequate liquidity and preserve capital.
F-13
The following table summarizes the Companys investments, by category, as of December 31, 2019 and 2018 (in thousands):
December 31, | December 31, | |||||||
2019 | 2018 | |||||||
Investments - Current: |
||||||||
Debt securities - available for sale |
$ | 25,746 | $ | 32,914 | ||||
|
|
|
|
|||||
Total |
$ | 25,746 | $ | 32,914 | ||||
|
|
|
|
|||||
Investments - Noncurrent: |
||||||||
Debt securities - available for sale |
$ | | $ | 16,804 | ||||
|
|
|
|
|||||
Total |
$ | | $ | 16,804 | ||||
|
|
|
|
A summary of the Companys available-for-sale classified investments as of December 31, 2019 and 2018 consisted of the following (in thousands):
At December 31, 2019 | ||||||||||||||||
Cost
Basis |
Unrealized
Gains |
Unrealized
Losses |
Fair
Value |
|||||||||||||
Investments - Current: |
||||||||||||||||
Corporate bonds |
$ | 4,990 | $ | | $ | (58 | ) | $ | 4,932 | |||||||
United States treasury securities |
20,979 | | (165 | ) | 20,814 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 25,969 | $ | | $ | (223 | )(1) | $ | 25,746 | |||||||
|
|
|
|
|
|
|
|
(1) |
$(12) of unrealized losses are included in the cash and cash equivalents balance as of December 31, 2019, a total of $(235) net unrealized losses at December 31, 2019. |
At December 31, 2018 | ||||||||||||||||
Cost
Basis |
Unrealized
Gains |
Unrealized
Losses |
Fair
Value |
|||||||||||||
Investments - Current: |
||||||||||||||||
Corporate bonds |
$ | 16,028 | $ | | $ | (19 | ) | $ | 16,009 | |||||||
United States treasury securities |
16,913 | | (8 | ) | 16,905 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 32,941 | $ | | $ | (27 | ) | $ | 32,914 | |||||||
|
|
|
|
|
|
|
|
|||||||||
Investments - Noncurrent: |
||||||||||||||||
Corporate bonds |
$ | 4,930 | $ | 2 | $ | | $ | 4,932 | ||||||||
United States treasury securities |
11,852 | 20 | | 11,872 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 16,782 | $ | 22 | $ | | $ | 16,804 | ||||||||
|
|
|
|
|
|
|
|
The amortized cost and fair value of the Companys available-for-sale investments, by contract maturity, as of December 31, 2019 consisted of the following (in thousands):
Amortized Cost | Fair Value | |||||||
Due in one year or less |
$ | 25,969 | $ | 25,746 | ||||
Due after one year through two years |
| | ||||||
|
|
|
|
|||||
Total |
$ | 25,969 | $ | 25,746 | ||||
|
|
|
|
F-14
4. |
PROPERTY AND EQUIPMENT, NET |
Property and equipment as of December 31, 2019 and 2018 consisted of the following (in thousands):
December 31,
2019 |
December 31,
2018 |
|||||||
Equipment |
$ | 1,278 | $ | 1,064 | ||||
Furniture and fixtures |
450 | 400 | ||||||
Leasehold improvements |
1,356 | 1,347 | ||||||
|
|
|
|
|||||
Total property and equipment |
3,084 | 2,811 | ||||||
Less: accumulated depreciation |
(850 | ) | (492 | ) | ||||
|
|
|
|
|||||
Property and equipment, net |
$ | 2,234 | $ | 2,319 | ||||
|
|
|
|
Depreciation expense for the years ended December 31, 2019 and 2018 was $357,000 and $288,000, respectively.
5. |
FAIR VALUE MEASUREMENTS |
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs.
The Company classified its money market funds within Level 1 because their fair values are based on their quoted market prices. The Company classified its United States treasury securities and fixed income securities within Level 2 because their fair values are determined using alternative pricing sources or models that utilized market observable inputs.
A summary of the assets and liabilities that are measured at fair value as of December 31, 2019 and 2018 is as follows (in thousands):
Fair Value Measurement at
December 31, 2019 |
||||||||||||||||
Carrying
Value |
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
Significant
other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
|||||||||||||
Assets: |
||||||||||||||||
Money market funds (1) |
$ | 21,065 | $ | 21,065 | $ | | $ | | ||||||||
United States treasury securities (1) |
5,982 | 5,982 | ||||||||||||||
Fixed income securities |
25,746 | | 25,746 | | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 52,793 | $ | 21,065 | $ | 31,728 | $ | | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Warrant liabilities |
$ | 299 | $ | | $ | | $ | 299 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 299 | $ | | $ | | $ | 299 | ||||||||
|
|
|
|
|
|
|
|
F-15
Fair Value Measurement at
December 31, 2018 |
||||||||||||||||
Carrying
Value |
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
Significant
other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
|||||||||||||
Assets: |
||||||||||||||||
Money market funds (1) |
$ | 13,264 | $ | 13,264 | $ | | $ | | ||||||||
Fixed income securities |
49,718 | | 49,718 | | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 62,982 | $ | 13,264 | $ | 49,718 | $ | | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Warrant liabilities |
$ | 8,511 | $ | | $ | | $ | 8,511 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 8,511 | $ | | $ | | $ | 8,511 | ||||||||
|
|
|
|
|
|
|
|
(1) |
Money market funds and United States treasury securities with maturities of 90 days or less at the date of purchase are included within cash and cash equivalents in the accompanying consolidated balance sheets and are recognized at fair value. |
The following table reflects the change in the Companys Level 3 liabilities, which consist of the warrants issued in a private placement in November 2016 (see Note 7), for the years ended December 31, 2019 and 2018 (in thousands):
November Private
Placement Warrants |
||||
Balance at December 31, 2017 |
$ | 13,128 | ||
Change in fair value |
(4,617 | ) | ||
|
|
|||
Balance at December 31, 2018 |
$ | 8,511 | ||
Change in fair value |
(8,212 | ) | ||
|
|
|||
Balance at December 31, 2019 |
$ | 299 | ||
|
|
6. |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES |
Accrued expenses as of December 31, 2019 and 2018 consisted of the following (in thousands):
December 31, | December 31, | |||||||
2019 | 2018 | |||||||
Preclinical and clinical studies |
$ | 1,473 | $ | 941 | ||||
Compensation and benefits |
614 | 830 | ||||||
Accounting and legal |
240 | 227 | ||||||
Other |
111 | 369 | ||||||
|
|
|
|
|||||
Total accrued expenses and other current liabilities |
$ | 2,438 | $ | 2,367 | ||||
|
|
|
|
7. |
WARRANTS |
In connection with the amendment and restatement of a license agreement with BioHEP Technologies Ltd. (BioHEP) in February 2016, the Company issued a warrant to purchase 125,000 shares of the Companys common stock to BioHEP (the BioHEP Warrant). The BioHEP Warrant had an exercise price of $16.00 per share. The Company evaluated the terms of the warrant and concluded that it should be equity-classified. The fair value of the warrant, $0.8 million, was estimated on the issuance date using a Black-Scholes pricing model based on the following assumptions: an expected term of two and a half years, expected stock price volatility of 71%, a risk-free rate of 1.01%, and a dividend yield of 0%. The fair value was expensed as research and development costs. The warrant expired unexercised on August 1, 2018.
F-16
In connection with the Companys IPO, the Company issued to the sole book-running manager for the IPO a warrant to purchase 27,600 shares of common stock in May 2016 and a warrant to purchase 747 shares of common stock in June 2016 (together, the IPO Warrants). The IPO Warrants are exercisable at an exercise price of $15.00 per share and expire on May 5, 2021. The Company evaluated the terms of the IPO Warrants and concluded that they should be equity-classified. The fair value of the May 2016 IPO Warrants was estimated on the applicable issuance dates using a Black Scholes pricing model based on the following assumptions: an expected term of 4.99 years; expected stock price volatility of 87%; a risk-free rate of 1.20%; and a dividend yield of 0%. The fair value of the June 2016 IPO Warrants was estimated on the applicable issuance dates using a Black Scholes pricing model based on the following assumptions: an expected term of 4.92 years; expected stock price volatility of 87%; a risk-free rate of 1.23%; and a dividend yield of 0%. The aggregate fair value of the IPO Warrants was $0.2 million.
In November 2016, the Company entered into a definitive agreement with respect to the private placement of 1,644,737 shares of common stock and warrants to purchase 1,644,737 shares of common stock (the November 2016 Private Placement Warrants) to a group of accredited investors. These investors paid $9.12 for each share of common stock and warrant to purchase one share of common stock. The November 2016 Private Placement Warrants are exercisable at an exercise price of $10.79 per share and expire on November 23, 2021. The Company evaluated the terms of these warrants and concluded that they are liability-classified. In November 2016, the Company recorded the fair value of these warrants of approximately $8.3 million using a Black-Scholes pricing model. The Company must recognize any change in the value of the warrant liability each reporting period in the statement of operations. As of December 31, 2019 and 2018, the fair value of the November 2016 Private Placement Warrants was approximately $0.3 million and $8.5 million, respectively and 10,960 shares have been exercised (see Note 5).
A summary of the Black Scholes pricing model assumptions used to record the fair value of the warrants is as follows:
For the Year Ended
December 31, |
||||||||
2019 | 2018 | |||||||
Risk-free interest rate |
1.6 | % | 2.5 | % | ||||
Expected term (in years) |
1.9 | 2.9 | ||||||
Expected volatility |
100.0 | % | 78.1 | % | ||||
Expected dividend yield |
0 | % | 0 | % |
In September 2019, the Company entered into a term loan (the Convertible Term Loan) with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders, and Pontifax Medison Finance GP, L.P., in its capacity as administrative agent and collateral agent for itself and the lenders, providing for a $20.0 million term loan (see Note 9). In connection with the Companys Convertible Term Loan, the Company issued to certain lenders warrants to purchase 250,000 shares of common stock (the Pontifax Warrants). The Pontifax Warrants are exercisable at an exercise price of $6.57 per share and expire on September 19, 2025. The Company evaluated the terms of the Pontifax Warrants and concluded that they are equity-classified. The fair value of the Pontifax Warrants was estimated on the issuance date using a Black-Scholes pricing model based on the following assumptions: an expected term of 6.0 years; expected stock price volatility of 83.2%; a risk-free interest rate of 1.7%; and a dividend yield of 0%. The aggregate fair value of the Pontifax Warrants was approximately $0.6 million and was recorded as a discount to the term loan and will be amortized over the life of the term loan using the effective interest rate method.
In September 2019, the Company issued warrants to a service provider to purchase 15,000 shares of common stock (the September 2019 Warrants). The September 2019 Warrants are exercisable at an exercise price of $4.21 per share and expire on September 19, 2021. The Company evaluated the terms of the September 2019 Warrants and concluded that they are equity-classified. The fair value of the September 2019 Warrants was estimated on the applicable issuance date using a Black-Scholes pricing model based on the following assumptions: an expected term of 2.0 years; expected stock price volatility of 69.4%; a risk-free interest rate of 1.7%; and a dividend yield of 0%. The aggregate fair value of the September 2019 Warrants was approximately
F-17
$19,000 and will be expensed over the life of the service contract. As of December 31, 2019, approximately $6,000 has been expensed.
A summary of the warrant activity for the years ended December 31, 2019 and 2018 is as follows:
Warrants | ||||
Outstanding at December 31, 2017 |
1,787,124 | |||
Grants |
| |||
Exercises |
| |||
Expirations/cancellations |
(125,000 | ) | ||
|
|
|||
Outstanding at December 31, 2018 |
1,662,124 | |||
Grants |
265,000 | |||
Exercises |
| |||
Expirations/cancellations |
| |||
|
|
|||
Outstanding at December 31, 2019 |
1,927,124 | |||
|
|
8. |
STOCKHOLDERS EQUITY |
Common Stock
In August 2017, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co. (Cantor), pursuant to which the Company may offer and sell, from time to time through Cantor, shares of the Companys common stock having an aggregate offering price of up to $50.0 million. The Company pays Cantor a commission rate equal to 3.0% of the aggregate gross proceeds from each sale. During the year ended December 31, 2019, the Company sold an aggregate of 600 shares of its common stock pursuant to the Sales Agreement at a weighted-average selling price of $10.03 per share, which resulted in de minimis net proceeds to the Company. During the year ended December 31, 2018, the Company sold an aggregate of 217,329 shares of its common stock pursuant to the Sales Agreement at a weighted-average selling price of $15.42 per share, which resulted in $3.2 million of net proceeds to the Company.
In August 2018, the Company issued and sold in an underwritten public offering an aggregate of 3,246,079 shares of its common stock at $12.50 per share, which included 246,079 shares pursuant to the exercise of an option to purchase additional shares granted to the underwriters in connection with the offering. The offering resulted in $38.0 million of net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.
2014 Stock Incentive Plan and 2015 Stock Incentive Plan
In April 2014, the Companys Board of Directors approved the 2014 Stock Incentive Plan (the 2014 Plan) and authorized 750,000 shares of common stock to be issued under the 2014 Plan.
The Companys 2015 Stock Incentive Plan (the 2015 Plan) became effective immediately prior to the closing of the Companys IPO on May 11, 2016. Upon the effectiveness of the 2015 Plan, 116,863 shares of common stock that remained available for grant under the 2014 Plan became available for grant under the 2015 Plan, and no further awards were available to be issued under the 2014 Plan.
The Companys Board of Directors initially adopted the 2015 Plan in December 2015, subject to stockholder approval, and authorized 750,000 shares of Common Stock to be issued under the 2015 Plan. The 2014 Plan and 2015 Plan provide for the issuance of common stock, stock options and other stock-based awards to employees, officers, directors, consultants and advisors of the Company.
Amended and Restated 2015 Stock Incentive Plan
In March 2018, the Board approved the Amended and Restated 2015 Plan. Upon receipt of stockholder approval at the Companys 2018 annual meeting in June 2018, the 2015 Plan was amended and restated in its entirety increasing the authorized number of shares of common stock reserved for issuance by 800,000 shares (together with the 2014 Plan, the 2015 Plan, the Stock Incentive Plans). Pursuant to the Amended and Restated 2015
F-18
Plan, there are 1,666,863 shares authorized for issuance. In addition, to the extent any outstanding awards under the 2014 Plan expire, terminate or are otherwise surrendered, cancelled or forfeited after the closing of the Companys IPO, those shares are added to the authorized shares under the Amended and Restated 2015 Plan. The total amount of shares authorized for issuance under both the 2014 Plan and the Amended and Restated 2015 Plan is 2,300,000. As of December 31, 2019, the Company had 348,673 shares available for issuance under the Amended and Restated 2015 Plan.
The exercise price of stock options cannot be less than the fair value of the common stock on the date of grant. Stock options awarded under the Stock Incentive Plans expire 10 years after the grant date, unless the Board sets a shorter term. There were no stock options granted prior to 2015.
The following table summarizes the option activity under the Stock Incentive Plans for the years ended December 31, 2019 and 2018:
Options |
Weighted-
Average Exercise Price Per Share |
Aggregate
Intrinsic Value |
||||||||||
Options outstanding at December 31, 2017 |
988,565 | $ | 10.83 | $ | 2,617,859 | |||||||
Granted |
311,000 | 12.28 | | |||||||||
Exercised |
| | | |||||||||
Cancelled |
| | | |||||||||
Options outstanding at December 31, 2018 |
1,299,565 | $ | 11.18 | $ | 2,617,859 | |||||||
Granted |
395,500 | 9.61 | | |||||||||
Exercised |
| | | |||||||||
Cancelled |
(22,750 | ) | 13.36 | | ||||||||
|
|
|||||||||||
Options outstanding at December 31, 2019 |
1,672,315 | $ | 10.78 | $ | | |||||||
|
|
|
|
|
|
|||||||
Options exercisable at December 31, 2019 |
1,072,811 | $ | 11.13 | $ | | |||||||
|
|
|
|
|
|
As of December 31, 2019, options outstanding have a weighted-average remaining contractual life of 7.2 years. The weighted-average fair value of all stock options granted for the year ended December 31, 2019 was $6.74. The intrinsic value at December 31, 2019 and 2018 is based on the closing price of the Companys common stock on that date of $1.58 per share and $10.39 per share, respectively.
In January 2018, the Company issued a stock option award as an inducement grant for the purchase of an aggregate of 50,000 shares of the Companys common stock, outside of the Stock Incentive Plans, at an exercise price of $12.02 per share. In February 2019, the Company issued a stock option award as an inducement grant for the purchase of an aggregate of 40,000 shares of the Companys common stock, outside of the Stock Incentive Plans, at an exercise price of $10.39 per share. These inducement grants are excluded from the option activity table above.
The assumptions the Company used to determine the fair value of stock options granted in 2019 and 2018 are as follows, presented on a weighted-average basis:
For the Year Ended
December 31, |
||||||||
2019 | 2018 | |||||||
Risk-free interest rate |
2.5 | % | 2.5 | % | ||||
Expected term (in years) |
5.9 | 5.9 | ||||||
Expected volatility |
81.1 | % | 82.5 | % | ||||
Expected dividend yield |
0 | % | 0 | % |
Performance-Based Restricted Stock Units
In January 2019, the Company issued RSUs to senior management under the 2015 Plan that represent shares potentially issuable in the future subject to the satisfaction of certain performance milestones as well as a service
F-19
condition. The vesting of 50% of the RSUs is based upon the Companys performance relative to a peer group over a two-year performance period, from January 1, 2019 through December 31, 2020, measured by the Companys relative total shareholder return. The vesting of 25% of the RSUs is based on the achievement of a performance goal milestone as of December 31, 2019 and the vesting of the remaining 25% of the RSUs is based upon the achievement of a performance goal milestone as of December 31, 2020.
The Company estimates the fair value of total shareholder return RSUs at the date of grant using a Monte Carlo valuation methodology and amortizes those fair values over the requisite service period for each separately vesting tranche of the award. The Monte Carlo methodology that the Company uses to estimate the fair value of total shareholder return RSUs at the date of grant incorporates into the valuation the possibility that the market condition may not be satisfied. Provided that the requisite service is rendered, the total fair value of the total shareholder return RSUs at the date of grant must be recognized as compensation expense even if the market condition is not achieved. However, the number of shares that ultimately vest can vary significantly with the performance of the specified market criteria.
The fair value of the performance-based RSUs granted to management in 2019 for the Companys relative total share return units is based on the Monte Carlo Simulation method on the grant date, which the weighted average fair value as of the year ended December 31, 2019 was $6.62 per share.
The Company estimates the fair value of performance milestone-based RSUs at the date of grant using the fair value method and the probability that the specified performance criteria will be met and amortizes the fair value over the requisite service period for each separately vesting tranche of the award when attainment of the milestone is deemed probable. The assumption used to determine the fair value of the RSUs granted to management during the year ended December 31, 2019 for the performance goal milestone units is based on the market price of the award on the grant date, which was a weighted average fair value for the year ended December 31, 2019 of $10.35 per share. Each quarter the Company updates its assessment of the probability that the specified milestone criteria will be achieved and adjusts its estimate of the fair value, if necessary. As of December 31, 2019, the Company has determined that it has not met the December 31, 2019 clinical milestones and reversed $0.1 million for previously recognized stock-based compensation expense and returned 46,450 shares to the plan.
As of December 31, 2019, the Company estimates that it is currently not probable that it will achieve the December 31, 2020 clinical milestones applicable to the milestone-based RSUs and has not recognized stock-based compensation expense for these RSUs as it relates to the December 31, 2020 milestone base goals. As of December 31, 2019, the Company reduced stock-based compensation by approximately $0.2 million for previously recognized stock-based compensation for the December 31, 2020 clinical milestones currently estimated to be not probable.
The total stock-based compensation recognized for the year ended December 31, 2019 for the RSUs related to the total shareholder return PSUs was approximately $0.3 million.
The following table is a rollforward of RSU activity under the Stock Incentive Plans for the year ended December 31, 2019:
Restricted
Stock Units |
Weighted-Average
Grant Date Fair Value |
|||||||
Total nonvested units at December 31, 2018 |
| $ | | |||||
Granted |
203,700 | 8.49 | ||||||
Vested |
| | ||||||
Cancelled |
(64,350 | ) | 9.83 | |||||
|
|
|
|
|||||
Total nonvested units at December 31, 2019 |
139,350 | $ | 7.86 | |||||
|
|
|
|
F-20
Stock-Based Compensation
The following table summarizes the stock-based compensation expense for the years ended December 31, 2019 and 2018 (in thousands):
For the Year Ended
December 31, |
||||||||
2019 | 2018 | |||||||
Stock-based compensation: |
||||||||
Research and development |
$ | 1,223 | $ | 843 | ||||
General and administrative |
2,144 | 1,933 | ||||||
|
|
|
|
|||||
Total Stock-based compensation |
$ | 3,367 | $ | 2,776 | ||||
|
|
|
|
The fair value of stock options vested during the year ended December 31, 2019 was $2.7 million. At December 31, 2019, there was $4.1 million of unrecognized stock-based compensation expense relating to stock options granted pursuant to the Plans, which will be recognized over the weighted-average remaining vesting period of 2.47 years.
At December 31, 2019, there was $0.3 million of unrecognized stock-based compensation expense relating to performance-based RSUs granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 1.0 years.
Reserved Shares
As of December 31, 2019 and 2018, the Company reserved the following shares of common stock for issuance of shares resulting from the exercise of outstanding warrants and options, as well as the future issuance of shares available for grant under the Stock Incentive Plans:
December 31, | ||||||||
2019 | 2018 | |||||||
IPO Warrants |
28,347 | 28,347 | ||||||
November Private Placement Warrants |
1,633,777 | 1,633,777 | ||||||
Convertible Term Loan and Accrued Interest Payable |
2,329,143 | | ||||||
Pontifax Warrants |
250,000 | | ||||||
September 2019 Warrants |
15,000 | | ||||||
2015 Amended and Restated Stock Incentive Plan |
2,160,338 | 2,238,887 | ||||||
Inducement Awards |
90,000 | 50,000 | ||||||
|
|
|
|
|||||
Total |
6,506,605 | 3,951,011 | ||||||
|
|
|
|
9. |
CONVERTIBLE TERM LOAN |
In September 2019, the Company entered into a Convertible Term Loan with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders, and Pontifax Medison Finance GP, L.P., in its capacity as administrative agent and collateral agent for itself and the lenders (collectively, the Lenders), providing for a $20.0 million term loan (the Convertible Term Loan), which the Company received on September 19, 2019 (the Closing Date). The Convertible Term Loan bears interest at an annual rate of 8.0%. The Convertible Term Loan provides for interest-only payments for twenty-four months and repayment of the aggregate outstanding principal balance of the Convertible Term Loan in quarterly installments starting upon expiration of the interest only period and continuing through September 19, 2023 (the Maturity Date). The Company incurred issuance costs of $0.4 million. The Convertible Term Loan issuance costs are shown as an offset to the Convertible Term Loan on the balance sheet and are amortized using the effective interest method to interest expense through the Maturity Date.
The Company may, at its option, prepay some or all of the then outstanding principal balance and all accrued and unpaid interest on the Convertible Term Loan, together with a prepayment charge equal to 3% of the principal
F-21
amount being prepaid. The Lenders may, at their option, elect to convert the then outstanding Convertible Term Loan amount and all accrued and unpaid interest thereon into shares of the Companys common stock at a conversion price of $8.76 per share, which is equal to two times the weighted average closing price of the Companys common stock during the 30 trading days prior to the execution of the Convertible Term Loan (the 30-day VWAP).
The Companys obligations are secured by a security interest, senior to any current and future debts and to any security interest, in all of the Companys right, title, and interest in, to and under all of its property and other assets, subject to limited exceptions including the Companys intellectual property. The Convertible Term Loan contains customary events of default, representations, warranties and covenants, including a material adverse effect clause. The Company must maintain a minimum cash balance of $7.0 million in Spring Bank Pharmaceuticals, Inc. accounts, or it is in breach of the Convertible Term Loan, which the Company is in compliance with as of December 31, 2019.
Upon the occurrence of an event of default, a default interest rate of an additional 4% per annum may be applied to the outstanding loan balances, and the Lenders may declare all outstanding obligations immediately due and payable and exercise all of its rights and remedies as set forth in the Convertible Term Loan and under applicable law. The Company evaluated the accounting for the Convertible Term Loan and identified an embedded derivative related to the contingent interest feature. At issuance and as of December 31, 2019, the Company determined the fair value of the contingent interest feature to be di minimis and will re-value the derivative at the end of each reporting period.
In addition, the Company issued the Lenders warrants to purchase an aggregate of 250,000 shares of the Companys common stock. The Pontifax Warrants are exercisable for a period of six years from the Closing Date at an exercise price of $6.57 per share, which is equal to 1.5 times 30-day VWAP. The aggregate fair value of the Pontifax Warrants was approximately $0.6 million and was recorded as a discount to the term loan and will be amortized over the life of the term loan using the effective interest rate method (see Note 7).
During the year ended December 31, 2019, the Company recorded interest expense of approximately $0.5 million in connection with the Convertible Term Loan. The fair value of the term loan as of December 31, 2019 approximates its face value due to market terms.
The following table summarizes the Companys future principal debt payments on the Convertible Term Loan as of December 31, 2019 (in thousands):
December 31,
2019 |
||||
2020 |
$ | | ||
2021 |
2,500 | |||
2022 |
10,000 | |||
2023 |
7,500 | |||
|
|
|||
Total principal payments |
$ | 20,000 | ||
Less: unamortized debt discount |
(930 | ) | ||
|
|
|||
Term loan, long-term |
$ | 19,070 | ||
|
|
10. |
LEASES |
The Company has operating leases for its principal office and laboratory space and the Companys former headquarters. The Companys leases have remaining lease terms of approximately 8.3 years for its principal office and laboratory space, which includes an option to extend the lease for up to 5 years, and approximately 2 years for its former headquarters. The Companys former headquarters location is subleased through the remainder of the lease term.
F-22
Other information related to leases as of December 31, 2019 was as follows:
For the Year Ended December 31, |
||||
2019 | ||||
Cash paid for amounts included in the measurement of lease liabilities: |
||||
Operating cash flow from operating leases (in thousands) |
$ | 417 | ||
Right-of-use assets obtained in exchange for lease obligations: |
||||
Operating leases (in thousands) |
$ | 2,980 | ||
Weighted Average Remaining Lease Term |
||||
Operating leases |
8.3 years | |||
Weighted Average Discount Rate |
||||
Operating leases |
8.0 | % |
Operating lease costs under the leases for the year ended December 31, 2019 were approximately $646,000, offset by $81,000, for sublease income and variable lease cost payments. Total rent expense for the year ended December 31, 2018 was $429,000, which included payments for a lease of the Companys research and development facility. The lease term of the research and development facility ended as of June 30, 2018.
The following table summarizes the Companys maturities of operating lease liabilities as of December 31, 2019 (in thousands):
Year |
||||
2020 |
$ | 588 | ||
2021 |
508 | |||
2022 |
450 | |||
2023 |
462 | |||
2024 |
474 | |||
Thereafter |
1,931 | |||
|
|
|||
Total lease payments |
$ | 4,413 | ||
Less: present value discount |
(1,189 | ) | ||
|
|
|||
Total |
$ | 3,224 | ||
|
|
For comparative purposes, the Companys aggregate future minimum non-cancellable commitments under operating leases as of December 31, 2018 were as follows (in thousands):
Year |
||||
2019 |
$ | 417 | ||
2020 |
588 | |||
2021 |
508 | |||
2022 |
450 | |||
2023 |
462 | |||
Thereafter |
2,405 | |||
|
|
|||
Total minimum lease payments |
$ | 4,830 | ||
|
|
11. |
INCOME TAXES |
In general, the Company has not recorded a provision for federal or state income taxes as it has had cumulative net operating losses since inception.
F-23
A reconciliation of the statutory U.S. Federal Tax Rate to the Companys effective tax rate is as follows:
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
U.S. statutory federal income tax rate |
(21.0 | )% | (21.0 | )% | ||||
State income taxes, net of federal income tax benefit |
(8.4 | )% | (7.6 | )% | ||||
Warrant adjustment |
(7.2 | )% | (4.2 | )% | ||||
Permanent items |
0.7 | % | 0.6 | % | ||||
R&D credit |
(0.6 | )% | (0.6 | )% | ||||
Change in valuation allowance |
36.5 | % | 32.7 | % | ||||
Change in federal rate impact |
| | ||||||
Other |
| 0.1 | % | |||||
|
|
|
|
|||||
Effective income tax rate |
0.0 | % | 0.0 | % | ||||
|
|
|
|
The significant components of the Companys deferred tax assets as of December 31, 2019 and 2018 are as follows (in thousands):
December 31, | ||||||||
2019 | 2018 | |||||||
Net operating loss carryforwards |
$ | 31,637 | $ | 23,582 | ||||
Research and development credits |
798 | 649 | ||||||
Lease liability |
881 | | ||||||
Accrued expenses |
173 | 209 | ||||||
License payments |
561 | 612 | ||||||
Stock based compensation |
2,004 | 1,383 | ||||||
Other net |
101 | 138 | ||||||
Deferred tax asset |
36,155 | 26,573 | ||||||
|
|
|
|
|||||
Valuation allowance |
(35,389 | ) | (26,536 | ) | ||||
Net deferred tax asset |
$ | 766 | $ | 37 | ||||
|
|
|
|
|||||
Right of use assets |
$ | (742 | ) | $ | | |||
|
|
|
|
|||||
Property and equipment |
(24 | ) | (37 | ) | ||||
|
|
|
|
|||||
Net deferred tax liability |
$ | (766 | ) | $ | | |||
|
|
|
|
|||||
Net deferred tax asset and liability |
$ | | $ | | ||||
|
|
|
|
Because of the Companys recurring losses since inception, management has concluded that it is more likely than not that its net deferred tax assets will not be realized and, accordingly, the Company provided a full valuation allowance against the net deferred tax assets. The valuation allowance increased by approximately $8.9 million in 2019 due to the increase in the deferred tax assets (primarily due to the net operating loss carryforwards). In comparison, the valuation allowance increased by approximately $7.5 million in 2018 due to the increase in the deferred tax assets (primarily due to the net operating loss carryforwards). At December 31, 2019, the Company had federal and state net operating loss carryforwards of approximately $115.6 million and $116.5 million, respectively, available to reduce future taxable income, if any. The federal net operating loss carryforwards expire beginning in 2029 and ending in 2037, with the exception of federal net operating losses created after tax years ending December 31, 2017. These net operating loss carryforwards of approximately $54.1 million have an indefinite life and do not expire. The state net operating loss carryforwards expire beginning in 2030 and ending in 2039. At December 31, 2019, the Company had available federal and state income tax credits of approximately $0.3 million and $0.6 million, respectively, which are available to reduce future income taxes, if any, through 2039.
Realization of the future tax benefits is dependent on many factors, including the Companys ability to generate taxable income within the net operating loss carryforward period. Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carry-forwards are subject to review and possible adjustment by the
F-24
Internal Revenue Service and state tax authorities. Net operating loss and tax credit carry-forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitations is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has completed several financings since its inception, which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code, or could result in a change in control in the future. The Company has performed a Section 382 study from its inception through December 31, 2017. The Company determined it experienced two ownership changes, but it expects to be able to utilize all its tax attributes despite the limitations calculated from the ownership changes. If ownership changes occur in the future, they could limit the amount of tax attributes available to offset tax due and increase the Companys tax expense adversely. The Company will continue to monitor changes in its ownership and update its Section 382 study in the future for those changes before its tax attributes are utilized.
The Company has generated research and development tax credits but has not conducted a study to document its activities that qualify for research and development tax credits. This study may result in an adjustment to the Companys research and development credit carryforwards; however, since the Company has not conducted a study any adjustment is unknown, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Companys research and development tax credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development tax credit carry-forwards and the valuation allowance.
The Company files income tax returns in the U.S. federal and Massachusetts jurisdictions. The statute of limitations for assessment by the Internal Revenue Service, or IRS, and state tax authorities is closed for tax years prior to 2015, although carryforward attributes that were generated prior to tax year 2015 may still be adjusted upon examination by the IRS or state tax authorities if they either have been or will be used in a future period. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. The Companys policy is to record interest and penalties on any unrecognized tax benefits as part of tax expense. The Company has not recorded any interest or penalties on any unrecognized tax benefits since its inception. The Company does not believe material uncertain tax positions have arisen to date.
12. |
COMMITMENTS AND CONTINGENCIES |
Contingencies
The Company accrues for contingent liabilities to the extent that the liability is probable and estimable. There are no accruals for contingent liabilities in these consolidated financial statements.
13. |
401(k) PLAN |
The Company has a 401(k)-defined contribution plan (the 401(k) Plan) for substantially all of its employees. Eligible employees may make pretax contributions to the 401(k) Plan up to statutory limits. At the election of its Board, the Company may elect to match employee contributions. For the years ended December 31, 2019 and 2018, the Company paid a match of up to 4%, up to the maximum permitted by the Internal Revenue Code, which amounted to $0.2 million and $0.1 million, respectively.
14. |
RELATED PARTY TRANSACTIONS |
During the years ended December 31, 2019 and 2018, the Company had no material related party transactions.
15. |
SUBSEQUENT EVENTS |
The Company has evaluated subsequent events through the date on which the consolidated financial statements were issued, to ensure that this submission includes appropriate disclosure of events both recognized in the consolidated financial statements and events which occurred subsequently but were not recognized in the consolidated financial statements.
F-25
SPRING BANK PHARMACEUTICALS, INC.
(In Thousands, Except Share and Per Share Data)
June 30,
2020 |
December 31,
2019 |
|||||||
ASSETS |
(unaudited) | |||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 8,531 | $ | 28,709 | ||||
Marketable securities |
14,990 | 25,746 | ||||||
Prepaid expenses and other current assets |
2,717 | 3,522 | ||||||
|
|
|
|
|||||
Total current assets |
26,238 | 57,977 | ||||||
Property and equipment, net |
2,043 | 2,234 | ||||||
Operating lease right-of-use assets |
2,576 | 2,717 | ||||||
Restricted cash |
234 | 234 | ||||||
Other assets |
| 35 | ||||||
|
|
|
|
|||||
Total |
$ | 31,091 | $ | 63,197 | ||||
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,530 | $ | 2,210 | ||||
Accrued expenses and other current liabilities |
2,239 | 2,438 | ||||||
Accrued interest payable |
| 403 | ||||||
Operating lease liabilities, current |
364 | 355 | ||||||
|
|
|
|
|||||
Total current liabilities |
5,133 | 5,406 | ||||||
Convertible term loan, net of unamortized discount |
| 19,070 | ||||||
Warrant liabilities |
38 | 299 | ||||||
Operating lease liabilities, noncurrent |
2,688 | 2,869 | ||||||
Other long-term liabilities |
| 27 | ||||||
|
|
|
|
|||||
Total liabilities |
7,859 | 27,671 | ||||||
|
|
|
|
|||||
Commitments and contingencies (Note 11) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.0001 par valueauthorized, 10,000,000 shares at June 30, 2020 and December 31, 2019; no shares issued or outstanding at June 30, 2020 and December 31, 2019 |
| | ||||||
Common stock, $0.0001 par valueauthorized, 200,000,000 shares at June 30, 2020 and December 31, 2019; 17,248,545 and 16,513,763 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively |
2 | 2 | ||||||
Additional paid-in capital |
164,118 | 161,924 | ||||||
Accumulated deficit |
(140,887 | ) | (126,165 | ) | ||||
Accumulated other comprehensive loss |
(1 | ) | (235 | ) | ||||
|
|
|
|
|||||
Total stockholders equity |
23,232 | 35,526 | ||||||
|
|
|
|
|||||
Total |
$ | 31,091 | $ | 63,197 | ||||
|
|
|
|
See accompanying notes to consolidated financial statements.
F-26
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
For the Three Months Ended
June 30, |
For the Six Months Ended
June 30, |
|||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | 3,204 | $ | 7,275 | $ | 8,507 | $ | 12,842 | ||||||||
General and administrative |
2,164 | 2,490 | 5,043 | 5,300 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
5,368 | 9,765 | 13,550 | 18,142 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from operations |
(5,368 | ) | (9,765 | ) | (13,550 | ) | (18,142 | ) | ||||||||
Other income (expense): |
||||||||||||||||
Interest income |
44 | 325 | 285 | 686 | ||||||||||||
Interest expense |
(35 | ) | | (511 | ) | | ||||||||||
Loss on extinguishment of convertible term loan |
(1,207 | ) | | (1,207 | ) | | ||||||||||
Change in fair value of warrant liabilities |
22 | 4,885 | 261 | 7,706 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
(6,544 | ) | (4,555 | ) | (14,722 | ) | (9,750 | ) | ||||||||
Unrealized gain/(loss) on marketable securities |
157 | (97 | ) | 234 | (213 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Comprehensive loss |
$ | (6,387 | ) | $ | (4,652 | ) | $ | (14,488 | ) | $ | (9,963 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per common sharebasic and diluted |
$ | (0.38 | ) | $ | (0.28 | ) | $ | (0.88 | ) | $ | (0.59 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Weighted-average number of shares outstandingbasic and diluted |
17,052,088 | 16,443,379 | 16,787,919 | 16,440,192 | ||||||||||||
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-27
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
FOR THE THREE MONTHS ENDED JUNE 30, 2020 AND 2019
(In Thousands, Except Share and Per Share Data)
For the Three Months Ended June 30, 2020 |
Common Stock |
Additional
Paid-in Capital |
Accumulated
Deficit |
Other
Comprehensive Income (Loss) |
Total
Stockholders Equity |
|||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at March 31, 2020 |
16,582,444 | $ | 2 | $ | 162,771 | $ | (134,343 | ) | $ | (158 | ) | $ | 28,272 | |||||||||||
Stock-based compensation |
| | 449 | | | 449 | ||||||||||||||||||
Issuance of common stock for services rendered |
17,006 | | 25 | | | 25 | ||||||||||||||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs |
649,095 | 819 | 819 | |||||||||||||||||||||
Convertible term loan warrant amendment |
54 | 54 | ||||||||||||||||||||||
Net unrealized gain on marketable securities |
| | | | 157 | 157 | ||||||||||||||||||
Net loss |
| | | (6,544 | ) | | (6,544 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2020 |
17,248,545 | $ | 2 | $ | 164,118 | $ | (140,887 | ) | $ | (1 | ) | $ | 23,232 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
For the Three Months Ended June 30, 2019 |
Common Stock |
Additional
Paid-in Capital |
Accumulated
Deficit |
Other
Comprehensive Income (Loss) |
Total
Stockholders Equity |
|||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at March 31, 2019 |
16,442,532 | $ | 2 | $ | 158,928 | $ | (107,263 | ) | $ | (121 | ) | $ | 51,546 | |||||||||||
Stock-based compensation |
| | 982 | | | 982 | ||||||||||||||||||
Issuance of common stock for services rendered |
16,023 | | 59 | | | 59 | ||||||||||||||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs |
600 | 6 | 6 | |||||||||||||||||||||
Net unrealized loss on marketable securities |
| | | | (97 | ) | (97 | ) | ||||||||||||||||
Net loss |
| | | (4,555 | ) | | (4,555 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2019 |
16,459,155 | $ | 2 | $ | 159,975 | $ | (111,818 | ) | $ | (218 | ) | $ | 47,941 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-28
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
FOR THE SIX MONTHS ENDED JUNE 30, 2020 AND 2019
(In Thousands, Except Share and Per Share Data)
For the Six Months Ended June 30, 2020 |
Common Stock |
Additional
Paid-in Capital |
Accumulated
Deficit |
Other
Comprehensive Income (Loss) |
Total
Stockholders Equity |
|||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2019 |
16,513,763 | $ | 2 | $ | 161,924 | $ | (126,165 | ) | $ | (235 | ) | $ | 35,526 | |||||||||||
Stock-based compensation |
| | 1,241 | | | 1,241 | ||||||||||||||||||
Issuance of common stock for services rendered |
43,887 | | 50 | | | 50 | ||||||||||||||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs |
690,895 | 849 | 849 | |||||||||||||||||||||
Convertible term loan warrant amendment |
54 | 54 | ||||||||||||||||||||||
Net unrealized gain on marketable securities |
| | | | 234 | 234 | ||||||||||||||||||
Net loss |
| | | (14,722 | ) | | (14,722 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2020 |
17,248,545 | $ | 2 | $ | 164,118 | $ | (140,887 | ) | $ | (1 | ) | $ | 23,232 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
For the Six Months Ended June 30, 2019 |
Common Stock |
Additional
Paid-in Capital |
Accumulated
Deficit |
Other
Comprehensive Income (Loss) |
Total
Stockholders Equity |
|||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2018 |
16,434,614 | $ | 2 | $ | 157,931 | $ | (102,068 | ) | $ | (5 | ) | $ | 55,860 | |||||||||||
Stock-based compensation |
| | 1,895 | | | 1,895 | ||||||||||||||||||
Issuance of common stock for services rendered |
23,941 | | 143 | | | 143 | ||||||||||||||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs |
600 | 6 | 6 | |||||||||||||||||||||
Net unrealized loss on marketable securities |
| | | | (213 | ) | (213 | ) | ||||||||||||||||
Net loss |
| | | (9,750 | ) | | (9,750 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2019 |
16,459,155 | $ | 2 | $ | 159,975 | $ | (111,818 | ) | $ | (218 | ) | $ | 47,941 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-29
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In Thousands)
For the Six Months Ended
June 30, |
||||||||
2020 | 2019 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (14,722 | ) | $ | (9,750 | ) | ||
Adjustments for: |
||||||||
Depreciation and amortization |
191 | 171 | ||||||
Operating lease right-of-use asset amortization |
141 | 130 | ||||||
Change in fair value of warrant liabilities |
(261 | ) | (7,706 | ) | ||||
Loss on extinguishment of convertible term loan |
1,207 | | ||||||
Non-cash interest expense |
77 | | ||||||
Non-cash investment income (expense) |
(244 | ) | 72 | |||||
Non-cash stock-based compensation |
1,291 | 2,013 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
805 | (753 | ) | |||||
Other assets |
35 | 132 | ||||||
Accounts payable |
320 | (155 | ) | |||||
Accrued expenses and other liabilities |
(629 | ) | 1,081 | |||||
Operating lease liabilities |
(172 | ) | | |||||
|
|
|
|
|||||
Net cash used in operating activities |
(11,961 | ) | (14,765 | ) | ||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Proceeds from sale of marketable securities |
32,234 | 16,787 | ||||||
Purchases of marketable securities |
(21,000 | ) | (6,000 | ) | ||||
Purchases of property and equipment |
| (205 | ) | |||||
|
|
|
|
|||||
Net cash provided by investing activities |
11,234 | 10,582 | ||||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Payment of convertible term loan and prepayment fee |
(20,300 | ) | | |||||
Proceeds from issuance of common stock in connection with at-the-market offering, net of issuance costs |
849 | 6 | ||||||
|
|
|
|
|||||
Cash (used in) provided by financing activities |
(19,451 | ) | 6 | |||||
|
|
|
|
|||||
Net decrease in cash, cash equivalents and restricted cash |
(20,178 | ) | (4,177 | ) | ||||
Cash, cash equivalents and restricted cash, beginning of period |
28,943 | 14,958 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash, end of period |
$ | 8,765 | $ | 10,781 | ||||
|
|
|
|
|||||
Supplemental disclosures of cash flow information: |
||||||||
Cash paid for taxes |
$ | 7 | $ | 17 | ||||
|
|
|
|
|||||
Cash paid for interest, net |
$ | 837 | $ | | ||||
|
|
|
|
See accompanying notes to consolidated financial statements.
F-30
Spring Bank Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of Business
Spring Bank Pharmaceuticals, Inc. (the Company) is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of a range of cancers and inflammatory diseases using its proprietary small molecule nucleotide platform. The Company designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. The Companys internally-developed programs are primarily designed to stimulate and/or dampen immune responses. The Company is devoting its resources to advancing multiple programs in its STING (STimulator of INterferon Genes) product portfolio.
Until January 2020, the Company was also developing inarigivir, an orally-administered investigational selective immunomodulator, as a potential treatment for chronic hepatitis B virus, or HBV. Inarigivir was being evaluated in multiple clinical trials, including the Companys Phase 2b CATALYST trials, designed to evaluate both treatment-naïve and virally-suppressed non-cirrhotic patients with HBV under multiple dosing regimens. On January 29, 2020, the Company announced that it terminated all clinical development of inarigivir for the treatment of HBV due to the occurrence of unexpected serious adverse events, including one patient death, in the Companys Phase 2b CATALYST trial.
On July 29, 2020, the Company and F-star Therapeutics Limited (F-star) entered into a Share Exchange Agreement (the Exchange Agreement) pursuant to which, subject to the satisfaction or waiver of the conditions set forth in the Exchange Agreement, the Company will acquire the entire issued share capital of F-star with F-star continuing as the combined company (the Exchange) (see Note 12).
Since its inception in 2002 and prior to its initial public offering (IPO) in May 2016, the Company built its technology platform and product candidate pipeline, supported by grants and through private financings. The Company has three wholly owned subsidiaries: Sperovie Biosciences, Inc. formed in September 2015, SBP Securities Corporation formed in December 2016 and SBP International Limited formed in May 2019.
The Companys success is dependent upon its ability to successfully complete clinical development and obtain regulatory approval of its product candidates, successfully commercialize approved products, generate revenue, and, ultimately, attain profitable operations.
The pandemic caused by an outbreak of a new strain of coronavirus, or the COVID-19 pandemic, that is affecting the U.S. and global economy and financial markets is also impacting the Companys employees, patients, communities and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Companys business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. The Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce.
Basis of Presentation and Liquidity
The accompanying consolidated financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP).
The accompanying interim financial statements as of June 30, 2020 and for the three and six months ended June 30, 2020 and 2019, and related interim information contained within the notes to the financial statements, are unaudited. In managements opinion, the unaudited interim consolidated financial statements have been prepared on the same basis as the Companys audited financial statements and include all adjustments (including normal recurring adjustments) necessary for the fair presentation of the Companys financial position as of June 30, 2020, results of operations for the three and six months ended June 30, 2020 and 2019, statement of
F-31
stockholders equity for the three and six months ended June 30, 2020 and 2019 and its cash flows for the six months ended June 30, 2020 and 2019. These interim financial statements should be read in conjunction with the Companys audited financial statements and accompanying notes contained in the Companys Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) on February 14, 2020. The results for the three and six months ended June 30, 2020 are not necessarily indicative of the results expected for the full fiscal year or any interim period.
As of June 30, 2020, the Company had an accumulated deficit of $140.9 million and $23.5 million in cash, cash equivalents and marketable securities. On April 8, 2020, the Company repaid in full its $20.0 million convertible term loan (see Note 9).
There is no guarantee that the Exchange will be completed. The Company expects its $23.5 million in cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund operations for at least the next twelve months. This estimate assumes no additional funding from new collaboration agreements, equity financings or further sales under the Companys Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co. (see Note 8).
The Company does not expect to raise any additional funds prior to the completion of the Exchange. However, if the Exchange is not completed, the Company may require significant additional funds earlier than it currently expects in order to conduct clinical trials and preclinical and discovery activities. There can be no assurances, however, that additional funding will be available on favorable terms, or at all. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, stockholders ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect common stockholder rights. If the Company raises additional funds through collaborations, strategic alliances or licensing arrangements with third parties, the Company may have to relinquish valuable rights to its technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to the Company.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Sperovie Biosciences, Inc., SBP Securities Corporation and SBP International Limited. Sperovie Biosciences, Inc. had operations consisting mainly of legal fees associated with intellectual property activities as of June 30, 2020. Sperovie Biosciences, Inc. was a joint borrower with the Company under the Companys convertible term loan (see Note 9). SBP Securities Corporation had assets primarily related to investments in marketable securities and operations consisting primarily of interest income as of June 30, 2020. SBP International Limited had operations consisting mainly of clinical trial oversight, including European data protection oversight, as of June 30, 2020. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates relied upon in preparing the accompanying financial statements related to the fair value of warrants, accounting for stock-based compensation, income taxes, useful lives of long-lived assets, and accounting for certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis. The Companys actual results may differ from these estimates.
Cash and Cash Equivalents
Cash equivalents are stated at fair value and include short-term, highly liquid investments with remaining maturities of 90 days or less at the date of purchase. Included in cash and cash equivalents as of June 30, 2020 are money market fund investments of $7.0 million and included in cash and cash equivalents as of
F-32
December 31, 2019 are money market fund investments of $21.1 million and United States treasury securities of $6.0 million, which are reported at fair value (see Note 5).
Restricted Cash
As of June 30, 2020 and December 31, 2019, restricted cash consists of approximately $234,000, which is held as a security deposit required in conjunction with a lease agreement for the Companys principal office and laboratory space entered into in October 2017.
Concentration of Credit Risk
Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable securities. Substantially all of the Companys cash is held at financial institutions that management believes to be of high credit quality. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits; however, these deposits may be redeemed upon demand and, therefore, bear minimal risk.
Investments in Marketable Securities
The Company invests excess cash balances in short-term and long-term marketable securities. The Company classifies investments in marketable securities as either held-to-maturity or available-for-sale based on facts and circumstances present at the time of purchase. At each balance sheet date presented, all investments in securities are classified as available-for-sale. The Company reports available-for-sale investments at fair value at each balance sheet date and includes any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of stockholders equity. Realized gains and losses are determined using the specific identification method and are included in other income (expense). If any adjustment to fair value reflects a decline in the value of the investment, the Company considers all available evidence to evaluate the extent to which the decline is other than temporary, including the intention to sell and, if so, marks the investment to market through a charge to the Companys consolidated statements of operations and comprehensive loss.
Property and Equipment, Net
Property and equipment are recorded at cost. Costs associated with maintenance and repairs are expensed as incurred. Depreciation is provided using the straight-line method over the estimated useful lives:
Asset Category |
Useful Life |
|
Equipment | 5-7 years | |
Furniture and fixtures | 5 years | |
Leasehold improvements |
Lesser of 10 years or the remaining term of the respective lease |
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (ROU) assets, other current liabilities and operating lease liabilities in the Companys consolidated balance sheets.
ROU assets represent the Companys right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Companys leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. The Companys lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
F-33
Impairment of Long-Lived Assets
Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, an impairment loss is recorded for the difference between the carrying value and fair value of the asset. As of June 30, 2020, no such impairment has occurred.
Research and Development Costs
Research and development expenses consist primarily of costs incurred for the Companys research activities, including discovery efforts, and the development of product candidates, which include:
|
expenses incurred under agreements with third parties, including contract research organizations, or CROs, that conduct research, preclinical activities and clinical trials on the Companys behalf as well as contract manufacturing organizations, or CMOs, that manufacture drug products for use in the Companys preclinical and clinical trials; |
|
salaries, benefits and other related costs, including stock-based compensation expense, for personnel in the Companys research and development functions; |
|
costs of outside consultants, including their fees, stock-based compensation and related travel expenses; |
|
the cost of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials; |
|
costs related to compliance with regulatory requirements; and |
|
facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. |
The Company expenses research and development costs as incurred. The Company recognizes external development costs based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors and its clinical investigative sites. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in the Companys consolidated financial statements as prepaid or accrued research and development expenses.
Warrants
The Company accounts for freestanding warrants within stockholders equity or as liabilities based on the characteristics and provisions of each instrument. The Company evaluates outstanding warrants in accordance with ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. If none of the criteria in the evaluation in these standards are met, the warrants are classified as a component of stockholders equity and initially recorded at their grant date fair value without subsequent remeasurement. Warrants that meet the criteria are classified as liabilities and remeasured to their fair value at the end of each reporting period.
Stock-Based Compensation
The Companys stock-based payments include stock options, performance-based restricted stock units (performance-based RSUs), time-based restricted stock units (time-based RSUs) and grants of common stock. The Company accounts for all stock-based payment awards granted to employees and nonemployees using a fair value method. The measurement date for employee awards is the date of grant, and stock-based compensation costs are recognized as expense over the employees requisite service period, which is generally the vesting period, on a straight-line basis. The Company accounts for forfeitures as they occur.
The Company measures the fair value of the performance-based RSUs relating to the total share return performance using a Monte Carlo valuation model. The Company measures the fair value of the performance-based RSUs relating to the milestone performance goals using the fair value method and the probability that the specified performance criteria will be met. Each quarter the Company updates its assessment of the probability that the specified milestone criteria will be achieved and adjusts its estimate of the fair value, if necessary. Stock-
F-34
based compensation expense is classified in the accompanying consolidated statements of operations and comprehensive loss based on the department to which the related services are provided.
Financial Instruments
The Companys financial instruments consist of cash equivalents, marketable securities, accounts payable, a term loan and liability classified warrants. The carrying amounts of cash and cash equivalents and accounts payable approximate their fair value due to the short-term nature of those financial instruments. The fair value of the marketable securities and liability classified warrants are remeasured to fair value each reporting period (see Note 5). The fair value of the term loan approximates its face value due to market terms.
Fair Value Measurements
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Accounting Standards Codification (ASC) 820, Fair Value Measurements and Disclosures (ASC 820), establishes a hierarchy of inputs used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Companys assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:
Level 1Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
Level 3Valuations that require inputs that reflect the Companys own assumptions that are both significant to the fair value measurement and unobservable.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instruments level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Companys assets and liabilities measured at fair value on a recurring basis include cash equivalents, marketable securities and warrant liabilities.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period, determined using the treasury-stock method and the as if-converted method, for convertible securities, if inclusion of these instruments is dilutive.
For the three and six months ended June 30, 2020 and 2019, both methods are equivalent. Basic and diluted net loss per share is described further in Note 2.
Income Taxes
Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax basis of existing assets and liabilities as well as net operating loss and tax credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
The Company assesses its income tax positions and records tax benefits based upon managements evaluation of the facts, circumstances and information available at the reporting date. For those tax positions where it is more
F-35
likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50% likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, no tax benefit is recognized in the consolidated financial statements. The Company classifies interest and penalties associated with such uncertain tax positions as a component of interest expense. As of June 30, 2020 and December 31, 2019, the Company has not identified any material uncertain tax positions.
Guarantees and Indemnifications
As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Companys request in such capacity.
The Company leases its principal office and laboratory space in Hopkinton, Massachusetts under a non-cancelable operating lease. The Company has standard indemnification arrangements under the lease that require it to indemnify the landlords against liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or nonperformance under the Companys lease.
Through June 30, 2020, the Company had not experienced any losses related to these indemnification obligations and no material claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.
Segment Information
Operating segments are identified as components of an enterprise about which separate and discrete financial information is available for evaluation by the chief operating decision maker, the Companys chief executive officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment and does not track expenses on a program-by-program basis.
Recently Issued Accounting Pronouncements
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework Changes to the Disclosure Requirement for Fair Value Measurement. This ASU removes, modifies and adds certain disclosure requirements of ASC Topic 820. The ASU is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted this standard as of January 1, 2020; however, the adoption of this standard did not impact the Companys consolidated financial statements.
2. NET LOSS PER SHARE
The following table summarizes the computation of basic and diluted net loss per share of the Company for such periods (in thousands, except share and per share data):
For the Three Months Ended
June 30, |
For the Six Months Ended
June 30, |
|||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Net loss |
$ | (6,544 | ) | $ | (4,555 | ) | $ | (14,722 | ) | $ | (9,750 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Weighted-average number of shares outstandingbasic and diluted |
17,052,088 | 16,443,379 | 16,787,919 | 16,440,192 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per common sharebasic and diluted |
$ | (0.38 | ) | $ | (0.28 | ) | $ | (0.88 | ) | $ | (0.59 | ) | ||||
|
|
|
|
|
|
|
|
Diluted net loss per common share is the same as basic net loss per common share for all periods presented.
F-36
The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact due to the losses reported:
For the Three and
Six Months Ended June 30, |
||||||||
2020 | 2019 | |||||||
Common stock warrants |
1,927,124 | 1,662,124 | ||||||
Stock options and inducement awards |
1,606,275 | 1,714,815 | ||||||
Restricted stock units |
534,000 | 185,800 |
3. INVESTMENTS
Cash in excess of the Companys immediate requirements is invested in accordance with the Companys investment policy that primarily seeks to maintain adequate liquidity and preserve capital.
The following table summarizes the Companys investments, by category, as of June 30, 2020 and December 31, 2019 (in thousands):
June 30,
2020 |
December 31,
2019 |
|||||||
InvestmentsCurrent: |
||||||||
Debt securitiesavailable for sale |
$ | 14,990 | $ | 25,746 | ||||
|
|
|
|
|||||
Total |
$ | 14,990 | $ | 25,746 | ||||
|
|
|
|
A summary of the Companys available-for-sale classified investments as of June 30, 2020 and December 31, 2019 consisted of the following (in thousands):
At June 30, 2020 | ||||||||||||||||
Cost
Basis |
Accumulated
Unrealized Gains |
Accumulated
Unrealized Losses |
Fair
Value |
|||||||||||||
InvestmentsCurrent: |
||||||||||||||||
United States treasury securities |
$ | 14,991 | $ | | $ | (1 | ) | $ | 14,990 | |||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 14,991 | $ | | $ | (1 | ) | $ | 14,990 | |||||||
|
|
|
|
|
|
|
|
|||||||||
At December 31, 2019 | ||||||||||||||||
Cost
Basis |
Accumulated
Unrealized Gains |
Accumulated
Unrealized Losses |
Fair
Value |
|||||||||||||
InvestmentsCurrent: |
||||||||||||||||
Corporate bonds |
$ | 4,990 | $ | | $ | (58 | ) | $ | 4,932 | |||||||
United States treasury securities |
20,979 | | (165 | ) | 20,814 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 25,969 | $ | | $ | (223 | )(1) | $ | 25,746 | |||||||
|
|
|
|
|
|
|
|
(1) $(12) of unrealized losses are included in the cash and cash equivalents balance as of December 31, 2019, a total of $(235) net unrealized losses at December 31, 2019.
The amortized cost and fair value of the Companys available-for-sale investments, by contract maturity, as of June 30, 2020 consisted of the following (in thousands):
Amortized Cost | Fair Value | |||||||
Due in one year or less |
$ | 14,991 | $ | 14,990 | ||||
|
|
|
|
|||||
Total |
$ | 14,991 | $ | 14,990 | ||||
|
|
|
|
F-37
4. PROPERTY AND EQUIPMENT, NET
Property and equipment as of June 30, 2020 and December 31, 2019 consisted of the following (in thousands):
June 30,
2020 |
December 31,
2019 |
|||||||
Equipment |
$ | 1,278 | $ | 1,278 | ||||
Furniture and fixtures |
423 | 450 | ||||||
Leasehold improvements |
1,356 | 1,356 | ||||||
|
|
|
|
|||||
Total property and equipment |
3,057 | 3,084 | ||||||
Less: accumulated depreciation and amortization |
(1,014 | ) | (850 | ) | ||||
|
|
|
|
|||||
Property and equipment, net |
$ | 2,043 | $ | 2,234 | ||||
|
|
|
|
Depreciation expense for the three and six months ended June 30, 2020 was $95,000 and $191,000, respectively. Depreciation expense for the three and six months ended June 30, 2019 was $88,000 and $171,000, respectively.
5. FAIR VALUE MEASUREMENTS
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs.
The Company classified its money market funds within Level 1 because their fair values are based on their quoted market prices. The Company classified its United States treasury securities and fixed income securities within Level 2 because their fair values are determined using alternative pricing sources or models that utilized market observable inputs.
A summary of the assets and liabilities that are measured at fair value as of June 30, 2020 and December 31, 2019 is as follows (in thousands):
Fair Value Measurement at
June 30, 2020 |
||||||||||||||||
Carrying
Value |
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
Significant
other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
|||||||||||||
Assets: |
||||||||||||||||
Money market funds(1) |
$ | 7,012 | $ | 7,012 | $ | | $ | | ||||||||
United States treasury securities |
14,990 | | 14,990 | | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 22,002 | $ | 7,012 | $ | 14,990 | $ | | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Warrant liabilities |
$ | 38 | $ | | $ | | $ | 38 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 38 | $ | | $ | | $ | 38 | ||||||||
|
|
|
|
|
|
|
|
F-38
Fair Value Measurement at
December 31, 2019 |
||||||||||||||||
Carrying
Value |
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
Significant
other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
|||||||||||||
Assets: |
||||||||||||||||
Money market funds (1) |
$ | 21,065 | $ | 21,065 | $ | | $ | | ||||||||
United States treasury securities (1) |
5,982 | | 5,982 | | ||||||||||||
Fixed income securities |
25,746 | | 25,746 | | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 52,793 | $ | 21,065 | $ | 31,728 | $ | | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Warrant liabilities |
$ | 299 | $ | | $ | | $ | 299 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 299 | $ | | $ | | $ | 299 | ||||||||
|
|
|
|
|
|
|
|
(1) |
Money market funds and United States treasury securities with maturities of less than 90 days at the date of purchase are included within cash and cash equivalents in the accompanying consolidated balance sheets and are recognized at fair value. |
The following table reflects the change in the Companys Level 3 liabilities, which consists of the warrants issued in a private placement in November 2016 (see Note 7), for the three months ended June 30, 2020 (in thousands):
November Private
Placement Warrants |
||||
Balance at December 31, 2018 |
$ | 8,511 | ||
Change in fair value |
(8,212 | ) | ||
|
|
|||
Balance at December 31, 2019 |
299 | |||
Change in fair value |
(261 | ) | ||
|
|
|||
Balance at June 30, 2020 |
$ | 38 | ||
|
|
6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued expenses as of June 30, 2020 and December 31, 2019 consisted of the following (in thousands):
June 30,
2020 |
December 31,
2019 |
|||||||
Preclinical and clinical studies |
$ | 1,124 | $ | 1,473 | ||||
Compensation and benefits |
765 | 614 | ||||||
Accounting and legal |
254 | 240 | ||||||
Other |
96 | 111 | ||||||
|
|
|
|
|||||
Total accrued expenses and other current liabilities |
$ | 2,239 | $ | 2,438 | ||||
|
|
|
|
7. WARRANTS
In connection with the Companys IPO, the Company issued to the sole book-running manager for the IPO a warrant to purchase 27,600 shares of common stock in May 2016 and a warrant to purchase 747 shares of common stock in June 2016 (together, the IPO Warrants). The IPO Warrants are exercisable at an exercise price of $15.00 per share and expire on May 5, 2021. The Company evaluated the terms of the IPO Warrants and concluded that they should be equity-classified. The fair value of the May 2016 IPO Warrants was estimated on the applicable issuance dates using a Black-Scholes pricing model based on the following assumptions: an expected term of 4.99 years; expected stock price volatility of 87%; a risk-free rate of 1.20%; and a dividend yield of 0%. The fair value of the June 2016 IPO Warrants was estimated on the applicable issuance dates using a
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Black-Scholes pricing model based on the following assumptions: an expected term of 4.92 years; expected stock price volatility of 87%; a risk-free interest rate of 1.23%; and a dividend yield of 0%. The aggregate fair value of the IPO Warrants on the date of issuance was approximately $0.2 million.
In November 2016, the Company entered into a definitive agreement with respect to the private placement of 1,644,737 shares of common stock and warrants to purchase 1,644,737 shares of common stock (the November 2016 Private Placement Warrants) to a group of accredited investors. These investors paid $9.12 for each share of common stock and warrant to purchase one share of common stock. The November 2016 Private Placement Warrants are exercisable at an exercise price of $10.79 per share and expire on November 23, 2021. The Company evaluated the terms of these warrants and concluded that they are liability-classified. In November 2016, the Company recorded the fair value of these warrants of approximately $8.3 million using a Black-Scholes pricing model. The Company must recognize any change in the value of the warrant liability each reporting period in the statement of operations. As of June 30, 2020 and December 31, 2019, the fair value of the November 2016 Private Placement Warrants was approximately $38,000 and $0.3 million, respectively, and 10,960 shares have been exercised to date (see Note 5).
A summary of the Black-Scholes pricing model assumptions used to record the fair value of the warrants is as follows:
June 30,
2020 |
December 31,
2019 |
|||||||
Risk-free interest rate |
0.2 | % | 1.6 | % | ||||
Expected term (in years) |
1.4 | 1.9 | ||||||
Expected volatility |
80.9 | % | 100.0 | % | ||||
Expected dividend yield |
0 | % | 0 | % |
In September 2019, the Company entered into a term loan (the Convertible Term Loan) with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders, and Pontifax Medison Finance GP, L.P., in its capacity as administrative agent and collateral agent for itself and the lenders, providing for a $20.0 million term loan (see Note 9). In connection with the Companys Convertible Term Loan, the Company issued to certain lenders warrants to purchase 250,000 shares of common stock (the Pontifax Warrants). Prior to their amendment in April 2020 (see Note 9), the Pontifax Warrants were exercisable at an exercise price of $6.57 per share. The Pontifax Warrants expire on September 19, 2025. The Company evaluated the terms of the Pontifax Warrants and concluded that they are equity-classified. The fair value of the Pontifax Warrants was estimated on the issuance date using a Black-Scholes pricing model based on the following assumptions: an expected term of 6.0 years; expected stock price volatility of 83.2%; a risk-free interest rate of 1.7%; and a dividend yield of 0%. The aggregate fair value of the Pontifax Warrants on the date of issuance was approximately $0.6 million and was recorded as a discount to the term loan and will be amortized over the life of the term loan using the effective interest rate method. The aggregate fair value remaining on the payoff date was $0.5 million and was included in the loss on extinguishment of the Convertible Term Loan upon repayment (see Note 9). In connection with the repayment of the Convertible Term Loan, the Pontifax Warrants were amended and restated to amend the exercise price to $2.08 per share, which was equal to 1.5 times the weighted-average closing price of the Companys Common Stock during the 90 days prior to the repayment date. All other terms of the Pontifax Warrants remained the same. During the three months ended June 30, 2020, there was an incremental expense of approximately $54,000 for the amendment of the Pontifax Warrant exercise price.
In September 2019, the Company issued warrants to a service provider to purchase 15,000 shares of common stock (the September 2019 Warrants). The September 2019 Warrants are exercisable at an exercise price of $4.21 per share and expire on September 19, 2021. The Company evaluated the terms of the September 2019 Warrants and concluded that they are equity-classified. The fair value of the September 2019 Warrants was estimated on the applicable issuance date using a Black-Scholes pricing model based on the following assumptions: an expected term of 2.0 years; expected stock price volatility of 69.4%; a risk-free interest rate of 1.7%; and a dividend yield of 0%. The aggregate fair value of the September 2019 Warrants on the date of issuance was approximately $19,000. Approximately $13,000 and $6,000 has been expensed during the periods ended June 30, 2020 and December 31, 2019, respectively.
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A summary of the warrant activity for the six months ended June 30, 2020 and for the year ended December 31, 2019 is as follows:
Warrants | ||||
Outstanding at December 31, 2018 |
1,662,124 | |||
Grants |
265,000 | |||
Exercises |
| |||
Expirations/cancellations |
| |||
|
|
|||
Outstanding at December 31, 2019 |
1,927,124 | |||
Grants |
| |||
Exercises |
| |||
Expirations/cancellations |
| |||
|
|
|||
Outstanding at June 30, 2020 |
1,927,124 | |||
|
|
8. STOCKHOLDERS EQUITY
Common and Preferred Stock
In August 2017, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co. (Cantor), pursuant to which the Company may offer and sell, from time to time through Cantor, shares of the Companys common stock having an aggregate offering price of up to $50.0 million. The Company pays Cantor a commission rate equal to 3.0% of the aggregate gross proceeds from each sale. During the three and six months ended June 30, 2020, the Company sold an aggregate of 649,095 and 690,895 shares of its common stock, respectively, pursuant to the Sales Agreement at a weighted-average selling price of $1.32 per share, during both periods, which resulted in approximately $0.8 million in net proceeds to the Company during both periods. During the three and six months ended June 30, 2019, the Company sold an aggregate of 600 shares of its common stock pursuant to the Sales Agreement at a weighted-average selling price of $10.03 per share, which resulted in de minimis net proceeds to the Company.
2014 Stock Incentive Plan and 2015 Stock Incentive Plan
In April 2014, the Companys Board of Directors approved the 2014 Stock Incentive Plan (the 2014 Plan) and authorized 750,000 shares of common stock to be issued under the 2014 Plan.
The Companys 2015 Stock Incentive Plan (the 2015 Plan) became effective immediately prior to the closing of the Companys IPO on May 11, 2016. Upon the effectiveness of the 2015 Plan, 116,863 shares of common stock that remained available for grant under the 2014 Plan became available for grant under the 2015 Plan, and no further awards were available to be issued under the 2014 Plan.
The Companys Board of Directors initially adopted the 2015 Plan in December 2015, subject to stockholder approval, and authorized 750,000 shares of Common Stock to be issued under the 2015 Plan. The 2014 Plan and 2015 Plan provide for the issuance of common stock, stock options and other stock-based awards to employees, officers, directors, consultants and advisors of the Company.
Amended and Restated 2015 Stock Incentive Plan
In March 2018, the Board approved the Amended and Restated 2015 Plan. Upon receipt of stockholder approval at the Companys 2018 annual meeting in June 2018, the 2015 Plan was amended and restated in its entirety increasing the authorized number of shares of common stock reserved for issuance by 800,000 shares (the Amended and Restated 2015 Plan, and together with the 2014 Plan, the Stock Incentive Plans). Upon receipt of stockholder approval at the Companys 2020 annual meeting in June 2020, the Amended and Restated 2015 Plan was further amended to increase the authorized number of shares of common stock reserved for issuance by 1,150,000 shares. Following this approval, there are 2,816,863 shares authorized for issuance pursuant to the Amended and Restated 2015 Plan. In addition, to the extent any outstanding awards under the 2014 Plan expire, terminate or are otherwise surrendered, cancelled or forfeited after the closing of the Companys IPO, those shares are added to the authorized shares under the Amended and Restated 2015 Plan.
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The total amount of shares authorized for issuance under all Stock Incentive Plans is 3,450,000. As of June 30, 2020, the Company had 1,216,176 shares available for issuance under the Amended and Restated 2015 Plan.
The exercise price of stock options cannot be less than the fair value of the common stock on the date of grant. Stock options awarded under the Stock Incentive Plans expire 10 years after the grant date, unless the Board sets a shorter term. There were no stock options granted prior to 2015.
The following table summarizes the option activity under the Stock Incentive Plans for the six months ended June 30, 2020 and the year ended December 31, 2019:
Options |
Weighted-
Average Exercise Price Per Share |
Aggregate
Intrinsic Value |
||||||||||
Outstanding at December 31, 2018 |
1,299,565 | $ | 11.18 | $ | 881,385 | |||||||
Granted |
395,500 | 9.61 | | |||||||||
Exercised |
| | | |||||||||
Cancelled |
(22,750 | ) | 13.36 | | ||||||||
|
|
|||||||||||
Outstanding at December 31, 2019 |
1,672,315 | 10.78 | | |||||||||
Granted |
270,000 | 1.44 | | |||||||||
Exercised |
| | | |||||||||
Cancelled |
(426,040 | ) | 10.45 | | ||||||||
|
|
|||||||||||
Options outstanding at June 30, 2020 |
1,516,275 | $ | 9.21 | $ | | |||||||
|
|
|
|
|
|
|||||||
Options exercisable at June 30, 2020 |
1,017,853 | $ | 10.79 | $ | | |||||||
|
|
|
|
|
|
As of June 30, 2020, all options outstanding have a weighted-average remaining contractual life of 6.6 years. The weighted-average fair value of all stock options granted for the six months ended June 30, 2020 was $0.99. Intrinsic value at June 30, 2020 and December 31, 2019 is based on the closing price of the Companys common stock on that date of $1.47 per share and $1.58 per share, respectively.
In January 2018, the Company issued a stock option award as an inducement grant for the purchase of an aggregate of 50,000 shares of the Companys common stock, outside of the Stock Incentive Plans, at an exercise price of $12.02 per share. In February 2019, the Company issued a stock option award as an inducement grant for the purchase of an aggregate of 40,000 shares of the Companys common stock, outside of the Stock Incentive Plans, at an exercise price of $10.39 per share. These inducement grants are excluded from the option activity table above.
The assumptions the Company used to determine the fair value of stock options granted to employees and directors during the six months ended June 30, 2020 and 2019 are as follows, presented on a weighted-average basis:
For the Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
Risk-free interest rate |
0.7 | % | 2.6 | % | ||||
Expected term (in years) |
5.9 | 6.0 | ||||||
Expected volatility |
82.8 | % | 81.1 | % | ||||
Expected dividend yield |
0 | % | 0 | % |
Restricted Stock Units
Performance-Based Restricted Stock Units
In January 2019, the Company issued performance-based RSUs to senior management under the Amended and Restated 2015 Plan that represented shares potentially issuable in the future subject to the satisfaction of certain performance milestones as well as a service condition. The vesting of 50% of the performance-based RSUs was based upon the Companys performance relative to a peer group over a two-year performance period, from
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January 1, 2019 through December 31, 2020, measured by the Companys relative total shareholder return. The vesting of 25% of the performance-based RSUs was based on the achievement of a performance goal milestone as of December 31, 2019 and the vesting of the remaining 25% of the performance-based RSUs was based upon the achievement of a performance goal milestone as of December 31, 2020.
The Company estimated the fair value of total shareholder return performance-based RSUs at the date of grant using a Monte Carlo valuation methodology and amortizes those fair values over the requisite service period for each separately vesting tranche of the award. The Monte Carlo methodology that the Company uses to estimate the fair value of total shareholder return performance-based RSUs at the date of grant incorporates into the valuation the possibility that the market condition may not be satisfied. Provided that the requisite service is rendered, the total fair value of the total shareholder return performance-based RSUs at the date of grant must be recognized as compensation expense even if the market condition is not achieved. However, the number of shares that ultimately vest can vary significantly with the performance of the specified market criteria.
The Company estimates the fair value of milestone performance-based RSUs at the date of grant using the fair value method and the probability that the specified performance criteria will be met and amortizes the fair value over the requisite service period for each separately vesting tranche of the award when attainment of the milestone is deemed probable. The assumption used to determine the fair value of the performance-based RSUs granted to management in 2019 for the performance goal milestone units is based on the market price of the award on the grant date. Each quarter the Company updates its assessment of the probability that the specified criteria will be achieved and adjusts its estimate of the fair value, if necessary.
As of December 31, 2019, the Company did not meet the 2019 milestone under the performance-based RSUs, and accordingly 46,450 shares were returned to the Amended and Restated 2015 Plan. The previously recognized expense of $0.3 million related to the 2019 milestone was reversed during the year ended December 31, 2019. The 2020 milestone was not deemed probable, and the previously recognized expense of $0.1 million was reversed during the year ended December 31, 2019. The Company recognized $0.3 million expense related to the total shareholder return component of the performance-based RSUs during the year ended December 31, 2019.
In March 2020, the Company and the recipients of these performance-based RSUs agreed to cancel the agreements and as a result, 139,350 shares were returned to the Amended and Restated 2015 Plan. The Company recognized the remaining expense for the total shareholder return performance-based RSUs in the amount of $0.3 million during the six months ended June 30, 2020. The Company did not recognize any expense related to the milestone performance-based RSUs.
In April 2020, the Company issued 360,000 performance-based RSUs to senior management under the Amended and Restated 2015 Plan that represented shares potentially issuable in the future subject to the satisfaction of certain performance milestones. The vesting of 50% of the performance-based RSUs is based on the achievement of a performance goal milestone as of December 31, 2020 and the vesting of the remaining 50% of the performance-based RSUs is based upon the achievement of a performance goal milestone as of December 31, 2021. For the three and six months ended June 30, 2020, the Company recognized approximately $44,000 expense related to the performance-based RSUs.
Time-Based Restricted Stock Units
In March 2020, the Company issued 199,000 time-based RSUs to employees under the Amended and Restated 2015 Plan. The weighted average grant date fair value of the time-based RSUs was $1.41 for the three and six months ended June 30, 2020. The vesting for the time-based RSUs is 50% after one-year from the grant date and the remaining 50% as of December 31, 2021. For the three and six months ended June 30, 2020, the Company recognized approximately $32,000 and $43,000 expense related to the time-based RSUs, respectively.
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The following table is a rollforward of all RSU activity under the Stock Incentive Plans for the six months ended June 30, 2020:
Restricted
Stock Units |
Weighted-Average
Grant Date Fair Value |
|||||||
Total nonvested units at December 31, 2019 |
139,350 | $ | 7.86 | |||||
Granted |
559,000 | 1.41 | ||||||
Vested |
| | ||||||
Cancelled |
(164,350 | ) | 6.88 | |||||
|
|
|
|
|||||
Total nonvested units at June 30, 2020 |
534,000 | $ | 1.07 | |||||
|
|
|
|
Stock-Based Compensation
The following table summarizes the Companys stock-based compensation expense for the three and six months ended June 30, 2020 and 2019 (in thousands):
For the Three Months
Ended June 30, |
For the Six Months
Ended June 30, |
|||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Stock-based compensation: |
||||||||||||||||
Research and development |
$ | 171 | $ | 339 | $ | 446 | $ | 656 | ||||||||
General and administrative |
303 | 702 | 845 | 1,357 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Stock-based compensation |
$ | 474 | $ | 1,041 | $ | 1,291 | $ | 2,013 | ||||||||
|
|
|
|
|
|
|
|
The fair value of stock options vested during the six months ended June 30, 2020 was $1.5 million. At June 30, 2020, there was $2.4 million of unrecognized stock-based compensation expense relating to stock options granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 2.2 years.
At June 30, 2020, there was $0.5 million of unrecognized stock-based compensation expense relating to the time-based RSUs granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 1.5 years.
Reserved Shares
As of June 30, 2020 and December 31, 2019, the Company reserved the following shares of common stock for issuance of shares resulting from exercise of outstanding warrants and options, convertible shares from the Convertible Term Loan, as well as issuance of shares available for grant under the Stock Incentive Plans:
June 30, | December 31, | |||||||
2020 | 2019 | |||||||
IPO warrants |
28,347 | 28,347 | ||||||
November private placement warrants |
1,633,777 | 1,633,777 | ||||||
Convertible term loan |
| 2,329,143 | ||||||
Pontifax warrants |
250,000 | 250,000 | ||||||
September 2019 warrants |
15,000 | 15,000 | ||||||
Amended and restated 2015 stock incentive plan |
3,266,451 | 2,160,338 | ||||||
Inducement awards |
90,000 | 90,000 | ||||||
|
|
|
|
|||||
Total |
5,283,575 | 6,506,605 | ||||||
|
|
|
|
9. CONVERTIBLE TERM LOAN
In September 2019, the Company entered into a Convertible Term Loan with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders, and Pontifax Medison Finance GP, L.P., in its capacity as administrative agent and collateral agent for itself and the lenders (collectively, the Lenders),
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providing for a $20.0 million term loan (the Convertible Term Loan), which the Company received on September 19, 2019 (the Closing Date). The Company incurred issuance costs of $0.4 million and Pontifax Warrants costs of $0.6 million. The Convertible Term Loan issuance costs and Pontifax Warrant costs are shown as an offset to the Convertible Term Loan on the balance sheet and are amortized using the effective interest method to interest expense through September 23, 2023 (the Maturity Date). In April 2020, the Company entered into a prepayment notice and pay-off letter with the Lenders, which provided for the full repayment in cash of the $20.0 million Convertible Term Loan and amended the exercise price with respect to the Pontifax Warrants. Upon repayment of the Convertible Term Loan, the Company incurred a loss on extinguishment of debt, which included $0.3 million for a prepayment fee, $0.4 million of unamortized issuance costs, $0.5 million in unamortized Pontifax Warrant costs and approximately $54,000 for the Pontifax Warrant amendment (see Note 7).
Pursuant to the Convertible Term Loan, the Company was entitled, at its option, to prepay some or all of the then outstanding principal balance and all accrued and unpaid interest on the Convertible Term Loan, together with a prepayment charge equal to 3% of the principal amount being prepaid. The Lenders were entitled, at their option, to elect to convert the then outstanding Convertible Term Loan amount and all accrued and unpaid interest thereon into shares of the Companys common stock at a conversion price of $8.76 per share.
The Companys obligations were secured by a security interest, senior to any current and future debts and to any security interest, in all of the Companys right, title, and interest in, to and under all of its property and other assets, subject to limited exceptions including the Companys intellectual property. The Convertible Term Loan contained customary events of default, representations, warranties and covenants, including a material adverse effect clause. The Company was required to maintain a minimum cash balance of $7.0 million in its accounts.
Upon the occurrence of an event of default, a default interest rate of an additional 4% per annum would have been applied to the outstanding loan balances, and the Lenders would have been able to declare all outstanding obligations immediately due and payable and exercise all of its rights and remedies as set forth in the Convertible Term Loan and under applicable law. The Company evaluated the accounting for the Convertible Term Loan and identified an embedded derivative related to the contingent interest feature. The Company determined the fair value of the contingent interest feature to be de minimis.
In addition, the Company issued the Lenders warrants to purchase an aggregate of 250,000 shares of the Companys common stock (the Pontifax Warrants). The Pontifax Warrants are exercisable for a period of six years from the Closing Date and were exercisable at an exercise price of $6.57 per share prior to their amendment in April 2020. The aggregate fair value of the Pontifax Warrants on the date of issuance was approximately $0.6 million and was recorded as a discount to the term loan and will be amortized over the life of the term loan using the effective interest rate method. The aggregate fair value remaining on the payoff date was $0.5 million and was included in the loss on extinguishment of the Convertible Term Loan upon repayment. In connection with the repayment of the Convertible Term Loan, the Pontifax Warrants were amended and restated to amend the exercise price to $2.08 per share, which was equal to 1.5 times the weighted-average closing price of the Companys Common Stock during the 90 days prior to the repayment date. All other terms of the Pontifax Warrants remained the same. During the three months ended June 30, 2020, there was an incremental expense of approximately $54,000 for the amendment of the Pontifax Warrant exercise price, which is included in the loss on extinguishment of debt (see Note 7).
During the three and six months ended June 30, 2020, the Company recorded interest expense of approximately $35,000 and $511,000, respectively, in connection with the Convertible Term Loan. There was no interest expense recorded during the three and six months ended June 30, 2019.
10. LEASES
The Company has operating leases for its principal office and laboratory space and the Companys former headquarters. The Companys leases have remaining lease terms of approximately 8.3 years for its principal office and laboratory space, which includes an option to extend the lease for up to 5 years, and approximately 0.9 years for its former headquarters. The Companys former headquarters location is subleased through the remainder of the lease term.
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Other information related to leases as of June 30, 2020 and 2019 was as follows:
For the Three Months
Ended June 30, |
For the Six
Months Ended June 30, |
|||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Cash paid for amounts included in the measurement of lease liabilities: |
||||||||||||||||
Operating cash flow from operating leases (in thousands) |
$ | 147 | $ | 91 | $ | 291 | $ | 130 | ||||||||
Right-of-use assets obtained in exchange for lease obligations: |
||||||||||||||||
Operating leases (in thousands) |
$ | | $ | 2,980 | $ | | $ | 2,980 |
As of June 30, 2020 and December 31, 2019, the weighted average remaining lease term for operating leases was 8.0 years and 8.3 years, respectively.
As of June 30, 2020 and December 31, 2019, the weighted average discount rate for operating leases was 8% for both periods.
Operating lease costs under the leases for the three and six months ended June 30, 2020 were approximately $165,000 and $330,000, respectively. Total operating lease costs for the three and six months ended June 30, 2020 were offset by $21,000 and $50,000, respectively, for sublease income and variable lease cost payments. Operating lease costs under the leases for the three and six months ended June 30, 2019 were approximately $130,000 and $260,000, respectively. Total operating lease costs for the three and six months ended June 30, 2019 were offset by $18,000 and $37,000, respectively, for sublease income and variable lease cost payments.
The following table summarizes the Companys maturities of operating lease liabilities as of June 30, 2020 (in thousands):
Year |
||||
2020 (excluding the six months ended June 30, 2020) |
$ | 297 | ||
2021 |
508 | |||
2022 |
450 | |||
2023 |
462 | |||
2024 |
474 | |||
Thereafter |
1,931 | |||
|
|
|||
Total lease payments |
$ | 4,122 | ||
Less: present value discount |
(1,070 | ) | ||
|
|
|||
Total |
$ | 3,052 | ||
|
|
11. COMMITMENTS AND CONTINGENCIES
Contingencies
The Company accrues for contingent liabilities to the extent that the liability is probable and estimable. There are no accruals for contingent liabilities in these consolidated financial statements.
12. SUBSEQUENT EVENTS
On July 29, 2020, the Company entered into the Exchange Agreement with F-star and the holders of outstanding shares and convertible notes of F-star. Under the terms of the Exchange, subject to the satisfaction or waiver of the conditions set forth in the Exchange Agreement, the Company will acquire the entire issued share capital of F-star, with F-star to continue as the combined company. The Exchange has been approved by the boards of directors of both companies and the equity holders of F-star and is expected to close in late 2020, subject to customary closing conditions, including the approval of the Companys stockholders. Upon completion of the Exchange, Spring Bank Pharmaceuticals, Inc. will be renamed F-star Therapeutics, Inc., and is expected to trade on the Nasdaq Capital Market under the ticker symbol FSTX.
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The Exchange is intended to create a company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies. The combined company will advance its immuno-oncology pipeline of multiple tetravalent bispecific antibody programs, including the Companys STING (STimulator of INterferon Gene) agonist, SB 11285, currently in a Phase 1/2 clinical trial.
The combined company will be led by Eliot Forster, Ph.D., MBA, F-star President and Chief Executive Officer, and will be headquartered in United Kingdom. The initial size of the Board of Directors of the Company will be eight and the initial directors are expected to be Nessan Bermingham, Ph.D., who shall be Chairman; David Arkowitz, MBA (continuing Company director); Edward Benz, MD; Todd Brady, MD, Ph.D. (continuing Company director); Eliot Forster, Ph.D., MBA; Pamela Klein, MD (continuing Company director); Patrick Krol, MBA; and Geoffrey Race, FCMA MBA. The resignations from the Companys board of directors of each of Timothy Clackson, Ph.D., Martin Driscoll, Kurt Eichler and Scott Smith will be effective as of the closing of the proposed Exchange.
The Company continues to conduct activities with respect to SB 11285, its intravenously-administered STING agonist product candidate, as well as other preclinical activities as described further in this prospectus/proxy statement.
The Company has evaluated subsequent events through the date on which the consolidated financial statements were issued to ensure appropriate disclosure of events both recognized in the consolidated financial statements and events which occurred subsequently but were not recognized in the consolidated financial statements.
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F-STAR THERAPEUTICS LIMITED
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page | ||||
Audited Financial Statements |
||||
F-50 | ||||
F-star Biotechnologische Forschungs-Und Entwicklungsges.m.b.H |
F-109 | |||
F-155 | ||||
F-star Therapeutics Limited, for the 6 months ended June 30, 2020 and 2019 |
F-192 |
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F-star Therapeutics Limited
Consolidated Financial Statements
for the period ended December 31, 2019
and the years ended December 31, 2018 and 2017
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F-star Therapeutics Limited
December 31, 2019
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of F-star Therapeutics Limited
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of F-star Therapeutics Limited and its subsidiaries (the Company) as of December 31, 2019, 2018 and 2017, and the related consolidated statements of comprehensive (loss)/income, consolidated statements of changes in equity and consolidated statements of cash flows for each of the three years in the period ended December 31, 2019, including the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019, 2018 and 2017, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2019 in conformity with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
Changes in Accounting Principles
As discussed in Note 2.1 to the consolidated financial statements, the Company has changed the manner in which it accounts for classification of expenses in 2019 and the manner in which it accounts for revenues from contracts with customers in 2018 discussed in Note 4.10.
Restatement of Previously Issued Financial Statements
As discussed in Note 4.9 to the consolidated financial statements, the Company has restated its 2018 and 2017 financial statements to correct errors.
Substantial Doubt About the Companys Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2.2 to the consolidated financial statements, the Company will require additional financing to fund its operating expenses and capital expenditure requirements which raises substantial doubt about its ability to continue as a going concern. Managements plans in regard to these matters are also described in Note 2.2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on the Companys consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
F-51
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
Cambridge, United Kingdom
August 28, 2020
We have served as the Companys or its predecessors auditor since 2013.
F-52
F-star Therapeutics Limited
December 31, 2019
Consolidated Statements of Comprehensive (Loss)/Income
Notes |
Year ended
£ |
Restated*
Year ended
£ |
Restated*
Year ended
£ |
|||||||||||
Revenue |
5 | 21,882,228 | 29,996,604 | 11,027,179 | ||||||||||
Costs related to collaborative arrangements |
6 | (17,960,094 | ) | (13,892,433 | ) | (6,345,668 | ) | |||||||
Research & development costs |
(32,672,545 | ) | | | ||||||||||
General & administrative expenses |
(12,294,739 | ) | (398,926 | ) | (616,048 | ) | ||||||||
Other income |
7 | 112,931 | | | ||||||||||
Other gains |
8 | 309,863 | 195,177 | 70,661 | ||||||||||
|
|
|
|
|
|
|||||||||
(Loss)/profit from operations |
9 | (40,622,356 | ) | 15,900,422 | 4,136,124 | |||||||||
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) |
21 | (1,106,313 | ) | | | |||||||||
Finance income |
11 | 8,412 | 4,308 | | ||||||||||
Finance costs |
11 | (255,554 | ) | | | |||||||||
|
|
|
|
|
|
|||||||||
(Loss)/profit before tax from continuing operations |
(41,975,811 | ) | 15,904,730 | 4,136,124 | ||||||||||
Income tax credit/(charge) |
12 | 7,016,499 | (2,636,132 | ) | (656,864 | ) | ||||||||
|
|
|
|
|
|
|||||||||
(Loss)/profit for the year attributable to equity holders of the parent |
(34,959,312 | ) | 13,268,598 | 3,479,260 | ||||||||||
|
|
|
|
|
|
|||||||||
Items that may be reclassified to profit or loss in subsequent periods: |
||||||||||||||
Foreign exchange arising on consolidation |
77,375 | | | |||||||||||
|
|
|
|
|
|
|||||||||
Other comprehensive income for the period |
77,375 | | | |||||||||||
|
|
|
|
|
|
|||||||||
Total comprehensive (loss)/income attributable to owners of the parent |
(34,881,937 | ) | 13,268,598 | 3,479,260 | ||||||||||
|
|
|
|
|
|
|||||||||
(Loss)/earnings per share for profit attributable to the shareholders of the parent: |
||||||||||||||
Basic and diluted (loss)/earnings per share |
28 | (2.37 | ) | 1.47 | 0.38 |
* |
See note 4.9 for explanation of restatement of prior year deferred tax. |
All activities relate to continuing activities.
The accompanying notes are an integral part of these consolidated financial statements.
F-53
F-star Therapeutics Limited
December 31, 2019
Consolidated Statements of Financial Position
Notes |
December 31,
£ |
Restated* December 31, 2018 £ |
Restated*^ December 31, 2017 £ |
|||||||||||||
Non-current assets |
||||||||||||||||
Goodwill |
13 | 2,811,827 | | | ||||||||||||
Intangible assets |
13 | 34,134,321 | 17,984,743 | 9,448,623 | ||||||||||||
Property, plant and equipment |
14 | 1,086,781 | | | ||||||||||||
Right-of-use assets |
15 | 462,520 | | | ||||||||||||
Financial assets at FVTPL |
16 | 42,662 | | | ||||||||||||
|
|
|
|
|
|
|||||||||||
38,538,111 | 17,984,743 | 9,448,623 | ||||||||||||||
|
|
|
|
|
|
|||||||||||
Current assets |
||||||||||||||||
Cash and cash equivalents |
17 | 3,736,229 | 6,458,139 | 3,780,060 | ||||||||||||
Current tax assets |
8,114,658 | 190,000 | | |||||||||||||
Trade and other receivables |
18 | 2,713,144 | 346,242 | 735,535 | ||||||||||||
|
|
|
|
|
|
|||||||||||
14,564,031 | 6,994,381 | 4,515,595 | ||||||||||||||
|
|
|
|
|
|
|||||||||||
Total assets |
53,102,142 | 24,979,124 | 13,964,218 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Equity |
||||||||||||||||
Issued share capital |
19 | 177,768 | 1 | 91 | ||||||||||||
Other reserves |
20 | 45,261,794 | 90 | | ||||||||||||
(Accumulated losses)/retained earnings |
20 | (16,907,806 | ) | 15,861,034 | 3,479,260 | |||||||||||
|
|
|
|
|
|
|||||||||||
Total equity |
28,531,756 | 15,861,125 | 3,479,351 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Non-current liabilities |
||||||||||||||||
Deferred revenue |
5 | | | 2,495,919 | ||||||||||||
Lease liability |
15 | 39,745 | | | ||||||||||||
Deferred tax |
1,655,295 | 2,973,578 | 336,841 | |||||||||||||
|
|
|
|
|
|
|||||||||||
1,695,040 | 2,973,578 | 2,832,760 | ||||||||||||||
|
|
|
|
|
|
|||||||||||
Current liabilities |
||||||||||||||||
Convertible notes held at FVTPL |
21 | 11,364,454 | | | ||||||||||||
Corporate tax liabilities |
84,317 | | 320,023 | |||||||||||||
Trade and other payables |
22 | 10,621,957 | 1,555,382 | 1,341,879 | ||||||||||||
Deferred revenue |
5 | 339,558 | 4,589,039 | 5,990,205 | ||||||||||||
Lease liability |
15 | 465,060 | | | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total current liabilities |
22,875,346 | 6,144,421 | 7,652,107 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total equity and liabilities |
53,102,142 | 24,979,124 | 13,964,218 | |||||||||||||
|
|
|
|
|
|
* |
See note 4.9 for explanation of restatement of prior year deferred tax. |
^ |
See note 4.10 for explanation of change in accounting policy. |
The accompanying notes are an integral part of these consolidated financial statements.
F-54
F-star Therapeutics Limited
December 31, 2019
Consolidated Statements of Changes in Equity
Notes |
Share
£ |
Other
£ |
Retained
(accumulated
£ |
Total equity £ |
||||||||||||||
Balance as of December 30, 2016 |
| | | | ||||||||||||||
Profit for the financial period and comprehensive income as originally stated |
| | 3,816,101 | 3,816,101 | ||||||||||||||
Transactions with owners of the Company, recognised directly in equity |
||||||||||||||||||
Proceeds from shares issued on incorporation |
91 | | | 91 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2017 as originally stated |
91 | | 3,816,101 | 3,816,192 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Restatement of prior year deferred tax |
4.9 | | | (336,841 | ) | (336,841 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Restated at December 31, 2017 |
91 | | 3,479,260 | 3,479,351 | ||||||||||||||
Adoption of new accounting standard |
4.10 | | | (886,824 | ) | (886,824 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Restated at 1 January 2018 |
91 | | 2,592,436 | 2,592,527 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Profit for the financial period and total comprehensive income as originally stated |
| | 15,905,335 | 15,905,335 | ||||||||||||||
Restatement* of prior year deferred tax |
4.9 | | | (2,636,737 | ) | (2,636,737 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Restated* profit for the financial period and comprehensive income |
| | 13,268,598 | 13,268,598 | ||||||||||||||
Arising on corporate reorganizationα |
(90 | ) | 90 | | | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Restated at December 31, 2018 |
1 | 90 | 15,861,034 | 15,861,125 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss for the financial year |
| | (34,959,312 | ) | (34,959,312 | ) | ||||||||||||
Other comprehensive income |
| | 77,375 | 77,375 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total comprehensive loss |
| | (34,881,937 | ) | (34,881,937 | ) | ||||||||||||
Transactions with owners in their capacity as owners |
||||||||||||||||||
Share based payment charge |
23 | | | 2,113,097 | 2,113,097 | |||||||||||||
Exercise of share options |
19 | 352 | | | 352 | |||||||||||||
Issues of shares on corporate reorganization, business combination and acquisition of asset |
19,20 | 177,415 | 45,261,704 | | 45,439,119 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
At December 31, 2019 |
177,768 | 45,261,794 | (16,907,806 | ) | 28,531,756 | |||||||||||||
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
α |
Prior year share capital has been restated to reflect the share capital of the legal acquirer. |
F-55
F-star Therapeutics Limited
December 31, 2019
Consolidated Statements of Cash Flows
Notes |
Year ended
£ |
Year ended
£ |
Year ended
£ |
|||||||||||
Cash flows from operating activities |
||||||||||||||
(Loss)/profit for the financial year before tax |
(41,975,811 | ) | 15,904,730 | 4,136,124 | ||||||||||
Adjustments for: |
||||||||||||||
Share-based payment expense |
23 | 2,113,097 | | | ||||||||||
Net finance cost |
11 | 247,142 | | | ||||||||||
Net exchange gains |
(182,802 | ) | | | ||||||||||
Amortization of intangible assets |
13 | 1,689,151 | 1,083,875 | 398,290 | ||||||||||
Depreciation of tangible fixed assets |
14,15 | 671,178 | | | ||||||||||
Loss on disposal of tangible fixed asset |
9 | 10,333 | | | ||||||||||
Loss on disposal of intangible asset |
3,953,127 | | | |||||||||||
Impairment of intangible assets |
13 | 6,608,387 | | | ||||||||||
Impairment of goodwill |
13 | 298,625 | | | ||||||||||
Fair value losses on financial liabilities through profit or loss |
21 | 1,106,313 | | | ||||||||||
Trade and other receivables |
18 | 153,369 | 389,293 | (735,535 | ) | |||||||||
Trade and other payables |
22 | 4,402,391 | 213,503 | 1,341,879 | ||||||||||
Change in deferred revenue |
(4,909,097 | ) | (3,897,085 | ) | 8,486,124 | |||||||||
Adoption of new accounting standard |
4.10 | | (886,824 | ) | | |||||||||
|
|
|
|
|
|
|||||||||
Adjusted (loss)/ profit before tax |
(25,814,597 | ) | 12,807,492 | 13,626,882 | ||||||||||
Proceeds from sale of intangible assets |
8,620,965 | | | |||||||||||
|
|
|
|
|
|
|||||||||
Cash (used in)/generated from operating activities |
(17,193,632 | ) | 12,807,492 | 13,626,882 | ||||||||||
Corporation tax received (paid) |
636,677 | (509,418 | ) | | ||||||||||
|
|
|
|
|
|
|||||||||
Net cash flows (used in)/generated from operating activities |
(16,556,955 | ) | 12,298,074 | 13,626,882 | ||||||||||
|
|
|
|
|
|
|||||||||
Cash flows from investing activities |
||||||||||||||
Proceeds from sale of tangible assets |
1,579 | | | |||||||||||
Payments to acquire intangible assets |
13 | (100,000 | ) | (9,619,995 | ) | (9,846,913 | ) | |||||||
Cash acquired with acquisition of subsidiaries* |
26 | 4,194,521 | | | ||||||||||
Interest received |
11 | 8,412 | | | ||||||||||
|
|
|
|
|
|
|||||||||
Net cash generated from/(used in) investing activities |
4,104,512 | (9,619,995 | ) | (9,846,913 | ) | |||||||||
|
|
|
|
|
|
|||||||||
Cash flows from financing activities |
||||||||||||||
Proceeds from issue of ordinary shares |
19 | 19 | | 91 | ||||||||||
Principal elements of lease payments |
15 | (296,094 | ) | | | |||||||||
Interest paid on leases |
15 | (22,394 | ) | | | |||||||||
Proceeds from convertible debt |
21 | 10,051,963 | | | ||||||||||
|
|
|
|
|
|
|||||||||
Net cash generated from financing activities |
9,733,494 | | 91 | |||||||||||
|
|
|
|
|
|
|||||||||
Net (decrease)/increase in cash and cash equivalents |
(2,718,949 | ) | 2,678,079 | 3,780,060 | ||||||||||
Cash and cash equivalents at the beginning of the year |
6,458,139 | 3,780,060 | | |||||||||||
Effects of exchange rate changes on cash and cash equivalents |
(2,961 | ) | | | ||||||||||
|
|
|
|
|
|
|||||||||
Cash and cash equivalents at end of year |
17 | 3,736,229 | 6,458,139 | 3,780,060 | ||||||||||
|
|
|
|
|
|
Reconciliation of movement in liabilities whose cash flows are recorded in financing activities is included in note 17.
* |
Consideration for acquisition of subsidiaries was entirely in the form of issued shares |
The accompanying notes are an integral part of these consolidated financial statements.
F-56
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
1. General information
F-star Therapeutics Limited (FTL) is the ultimate parent company of the group and its registered office address is Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT.
The activity of the group is research and development (R&D) and clinical activities within the biotechnology sector, to improve the lives of patients with cancer. The business includes pre-clinical and clinical development of our mAb2 product candidates, and the granting of technology licenses to collaboration partners within the biotechnology sector.
On May 7, 2019, FTL acquired in a share for share exchange, F-star Delta Ltd (Delta), F-star Beta Ltd (Beta), F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H. (GmbH), and F-star Alpha Ltd (Alpha) (collectively, the F-star Group Entities). No other assets, including cash, were transferred or liabilities assumed as consideration for the corporate reorganization, business combination and asset acquisition.
Prior to the corporate reorganization, business combination and asset acquisition the F-star Group entities shared some common directorships and some common shareholders. Due to the variations in shareholdings in each entity they were deemed to be related parties, but were not deemed to be under common control. Therefore, the above transactions to enact the formation of the group headed by F-star Therapeutics Limited were not deemed to be a common control transactions, with the exception of the corporate reorganization where shares in F-star Therapeutics Limited were issued to the shareholders of Delta for its acquisition, at a 1:1 ratio.
These financial statements were authorized for issue by the board of directors on August 28, 2020.
2. Summary of significant accounting policies
The principal accounting policies applied in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.
2.1 Basis of preparation
These consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) and IFRS Interpretations Committee (IFRS IC) as issued by the International Accounting Standards Board (IASB).
These financial statements have been prepared under the historical cost convention, modified to include revaluation to fair value of certain financial instruments at fair value through profit or loss, as described below.
Subsidiaries are all entities (including structured entities) over which the group has control. The group controls an entity when the group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the group. They are deconsolidated from the date that control ceases.
FTL, the legal acquirer of the F-star Group Entities, is an entity with no historical operations and was created solely for the purpose of effecting the corporate reorganization. Accordingly, for accounting purposes, it was not deemed substantive nor the accounting acquirer of the F-star Group Entities. In accordance with the amended guidance in IFRS 3 Business Combinations, the transaction was accounted for as a reorganization with Delta as the accounting acquirer. On acquisition, GmbH and Beta met the definition of a business in accordance with IFRS 3 Business Combinations, while Alpha did not meet this definition and was accounted for as an asset acquisition. Therefore, the reorganization has been accounted for as Delta obtaining a controlling interest in GmbH and Beta, and a controlling interest in Alpha through asset acquisition.
Therefore, although the consolidated financial statements are issued in the name of FTL, the legal acquirer, the groups activity is in substance the continuation of the financial information of Delta. The consolidated financial statements comprise the results of Delta for the full financial year to December 31, 2019 and the results of FTL
F-57
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
and GmbH, Alpha and Beta from May 7, 2019, the date of the corporate reorganization. The comparative information presented in the consolidated financial statements represents the historical financial performance and financial position of Delta only.
Intercompany transactions, balances and unrealized gains on transactions between Group companies are eliminated. Unrealized losses are also eliminated.
All of the subsidiaries of the group are 100% owned within the group. Associates are all entities over which the group has significant influence but not control, generally accompanying a shareholding of between 20% and 50% of the voting rights. The group holds 20% of the participation rights of each of two entities: S-TARget therapeutics GmbH, Vienna and OncoQR ML GmbH, Vienna. The participation rights grant entitlement to a share in dividend income or proceeds on sale from each of these entities but no voting rights and therefore the group does not exercise significant influence. Therefore, these investments are accounted for according to IFRS 9 Financial Instruments.
All group undertakings included in the consolidation have a coterminous date of statement of financial position.
Following a management review of the presentation of the consolidated statement of (loss)/income for the current reporting period, it was determined that a by function presentation would provide more reliable and relevant information to the users of the financial statements. Therefore, for comparability of the data presented, for the years ended December 31, 2018, and 2017 the presentation of the consolidated statements of comprehensive income has been changed to a by function presentation, whereas the previous presentation was by nature. Due to this presentational change and the associated requirements of IAS 1 Presentation of financial statements, the company adopted a policy of classifying certain costs as costs related to collaborative arrangements (see note 2.20).
The following table illustrates the reclassification of costs from other expenses under the by nature presentational format to the revised expense categories under the by function presentational format the for the years ended December 31, 2018 and December 31, 2017:
Presentation by Nature | Presentation by function | |||||||||||||||||||
Other
expenses £ |
Total
£ |
Costs related to
collaborative arrangements £ |
General &
administrative expenses £ |
Total
£ |
||||||||||||||||
Year ended December 31, 2018 |
14,291,359 | 14,291,359 | 13,892,433 | 398,926 | 14,291,359 | |||||||||||||||
Year ended December 31, 2017 |
6,961,716 | 6,961,716 | 6,345,668 | 616,048 | 6,961,716 |
Segmental reporting
The single operating segment is reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Board of Management that makes strategic decisions.
2.2 Going concern
As of August 28, 2020, the date of approval of the consolidated financial statements for the period ended December 31, 2019, the company does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about the companys ability to continue as a going concern
The company expects to seek equity financing from existing and new investors in conjunction with the contemplated Share Exchange Agreement entered into on July 29, 2020 between F-star Therapeutics Limited and
F-58
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
Spring Bank Pharmaceuticals Inc. The closing of the Share Exchange Agreement would provide access to the existing cash deposits of Spring Bank Pharmaceuticals Inc as well as expected additional equity financing to be raised by F-star Therapeutics Limited as part of the Exchange. The estimated closing is anticipated in Q4 2020. The closing of the Share Exchange Agreement is however subject to approval by the shareholders of Spring Bank Pharmaceuticals Inc. If the merger is unsuccessful, the company will seek additional funding through equity financing from existing shareholders, or other alternative sources, which the directors believe can be obtained. Accordingly, the directors believe it is appropriate to continue to adopt the going concern basis of accounting.
2.3 Estimates and judgments
In the application of the groups accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are relevant. Actual results may differ from these estimates. See note 4 for details of critical estimates and judgments.
2.4 New standards, amendments and IFRIC interpretations
New standards, amendments and interpretations adopted by the group
The group has adopted all relevant IFRSs that were effective for periods beginning January 1, 2019. The following standards have been adopted by the group for the first time for the fiscal year beginning on January 1, 2019:
IFRS 16 Leases
IFRS 16, Leases (effective date January 1, 2019) replaces the current guidance in IAS 17, Leasing. The group had no leases in the comparative year and therefore the new accounting standard has not impacted the accumulated losses as at January 1, 2018 or January 1, 2019.
As a result of the corporate reorganization on May 7, 2019, the group acquired lease liabilities which had previously been classified as operating leases under the principles of IAS 17 Leases. These liabilities were measured at the present value of the remaining lease payments, discounted using the lessees incremental borrowing rate as of May 7, 2019. The weighted average lessees incremental borrowing rate applied to the lease liabilities on May 7, 2019 was 5%.
Management elected to apply IFRS 16 using a modified retrospective transition method and has elected to apply the following practical expedients:
|
application of a single discount rate to a portfolio of leases with reasonably similar characteristics |
|
reliance on previous assessments on whether leases are onerous as an alternative to performing an impairment review there were no onerous contracts as at January 1, 2019 |
|
accounting for operating leases with a remaining lease term of less than 12 months as at January 1, 2019 as short-term leases |
|
use of hindsight in determining the lease term where the contract contains options to extend or terminate the lease |
|
electing to not separate lease and non-lease components and instead accounting for both as if it were one lease component |
|
payments associated with short-term leases of equipment and vehicles and all leases of low value assets are recognized on a straight-line basis as an expense in profit or loss. |
F-59
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
The adoption of IFRS 16 has affected the following items in the consolidated statement of financial position as at May 7, 2019 the date of acquisition of the lease liabilities and associated right-of-use assets:
|
right-of-use assets increase by £740,262 |
|
lease liability increase by £800,899 |
The net impact on net assets acquired was a decrease of £60,636.
The group accounting policies with regards to leases are disclosed in section 2.21 of this note.
There are no other amendments to accounting standards or IFRIC interpretations that are effective for the year ended December 31, 2019 that have had a material impact on the groups financial statements.
Any new or amended Accounting Standards or Interpretations that are not yet mandatory have not been early adopted.
New standards, amendments and interpretations not yet adopted
IFRS 3 Business Combinations
IFRS 3 Business Combinations was amended on October 18, 2018 to change the definition of a business and is to be applied to business combinations for periods beginning on or after January 1, 2020 with early adoption permitted.
2.5 Foreign currency translation
Functional and presentational currency
The consolidated financial statements are presented in pounds sterling, which is the groups presentation currency. Items included in the consolidated financial statements of each of the groups entities are measured using the currency of the primary economic environment in which the entity operates (the functional currency). Functional currencies of the consolidated entities are as follows:
F-star Therapeutics Limited, Cambridge, U.K. |
pounds sterling | |
F-star Delta Limited, Cambridge, U.K. |
pounds sterling | |
F-star GmbH, Vienna, Austria |
euro | |
F-star Biotechnology Limited, Cambridge, U.K. |
pounds sterling | |
F-star Alpha Limited, Cambridge, U.K. |
pounds sterling | |
F-star Beta Limited, Cambridge, U.K. |
pounds sterling | |
F-star Therapeutics LLC, Delaware, U.S |
U.S. dollar |
The results and financial position of all group entities (none of which has the currency of a hyper-inflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:
a. |
assets and liabilities for each date of consolidated statements of financial position presented are translated at the closing rate as of the date of that consolidated statement of financial position; |
b. |
income and expenses for each consolidated statement of comprehensive (loss)/income are translated at average exchange rates (unless this average is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the rate on the dates of the transactions); and |
c. |
all resulting exchange differences are recognized in other comprehensive income. |
Transactions and balances
Foreign currency transactions are translated into pounds sterling, the groups functional currency, using the exchange rates prevailing at the date of the transactions or valuation where items are remeasured. Foreign
F-60
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
exchange gains and losses resulting from the settlement of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statement of comprehensive (loss)/income. Foreign exchange gains and losses that relate to borrowings and cash and cash equivalents are presented in the statement of comprehensive (loss)/income within finance income or costs. All other foreign exchange gains and losses are presented within other gains in the consolidated statement of comprehensive (loss)/income.
2.6 Property, plant and equipment
Items of property, plant and equipment are measured at cost less accumulated depreciation and any accumulated impairment losses. If significant parts of an item of property, plant and equipment have different useful lives, then they are accounted for as separate items. Subsequent expenditure is capitalized only if it is probable that the future economic benefits associated with the expenditure will flow to the group.
Expenditure on repairs and maintenance is charged to the consolidated statement of comprehensive (loss)/income as incurred. Cost and related accumulated depreciation of property, plant and equipment sold or otherwise disposed of are derecognized and any gain or loss is reported as current years income or expense. Currently, no borrowing costs are added to the costs of assets as the group has not acquired or constructed assets that necessarily take a substantial period of time to get ready for their intended use or sale (qualifying assets).
Depreciation is charged so as to write off the cost of the assets over their estimated useful economic lives, using the straight-line method, on the following basis:
Leasehold property improvements, right of use assets |
Lesser of useful life or period of the lease | |
Plant and machinery |
20% on cost | |
Office equipment, fixtures and fittings |
33% on cost |
Depreciation methods, useful lives and residual values are reviewed as of each reporting date and adjusted, if appropriate.
2.7 Intangible assets
Expenditure on research activities are recognized in the consolidated statement of comprehensive (loss)/income as incurred. Development expenditure is capitalized only if the expenditure can be measured reliably, the product is technically and commercially feasible, future economic benefits are probable, and the group has sufficient resources to complete or sell the asset.
Acquired intangible assets, including intellectual property rights that have finite useful lives, are measured at cost less accumulated amortization and any accumulated impairment losses.
Subsequent expenditure is capitalized only when it increases the future economic benefits of the asset to which it relates. All other expenditure is recognized in the consolidated statements of comprehensive income as incurred.
Proceeds received from the license of perpetual, exclusive intellectual property licensing arrangements are classified as revenue. See note 2.20 for a description of the accounting policies for amortization and derecognition of intangible assets that relate to revenue-generating R&D activities.
Intangible assets are amortized over their estimated useful economic lives, using the straight-line method:
Intellectual Property Rights |
Over the remaining life of the relevant patents (full life assumed to be 20 years). This results in a range of UELs between 20 and 7 years |
2.8 Impairment of non-financial assets
At the date of the consolidated statement of financial position, the group reviews the carrying amounts of its long-lived assets to determine whether there is any indication that those assets have suffered an impairment loss.
F-61
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
For the purpose of measuring recoverable amounts, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units or CGUs). The recoverable amount is the higher of fair value less cost of disposal and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the estimates of future cash flows have not been adjusted.
If the recoverable amount of an asset is estimated to be less than its carrying amount, the carrying amount of the asset is reduced to its recoverable amount. An impairment loss is recognized as part of operating expenses immediately.
2.9 Financial instruments
i. Financial assets
Classification
The group classifies its financial assets in the following measurement categories:
|
measured at fair value |
|
measured at amortized cost |
The classification depends on the groups business model for managing the financial assets and the contractual terms of the cash flows. For assets measured at fair value, gains and losses are recorded in profit or loss.
The group has financial assets held at fair value through profit or loss, these comprise of unlisted participation rights. Financial assets at amortized cost include Trade and other receivables and Cash and cash equivalents and Other receivables excluding prepayments and other non-financial receivables.
Recognition and derecognition
Financial assets are derecognized when the right to receive cash flows from the financial assets has expired or has been transferred and the group has transferred substantially all the risks and rewards of ownership.
Measurement
At initial recognition, the group measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss (FVPL), transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets carried at FVPL are expensed in the consolidated statement of comprehensive (loss)/income. The group subsequently measures all equity investments at fair value.
Changes in the fair value of financial assets at FVPL are recognized in other income or other expenses in the consolidated statements of comprehensive income as applicable.
Subsequent measurement of receivables depends on the groups business model for managing the asset and the cash flow characteristics of the asset. Assets that are held for collection of contractual cash flows where those cash flows represent solely payments of principal and interest are measured at amortized cost. As of December 31, 2018, and December 31, 2019, all receivables in the group are held at amortized cost. Interest income from these financial assets is included in finance income using the effective interest rate method. Any gain or loss arising on derecognition is recognized directly in the consolidated statement of comprehensive (loss)/income and presented in other income or other expenses together with foreign exchange gains and losses. Impairment losses are presented as a separate line item in the consolidated statement of comprehensive (loss)/income to the extent such charges have been recorded.
The company adopted IFRS 9 Financial Instruments on 1 January 2018, therefore the information presented for the year ended December 31, 2017 continues to be accounted for under the groups previous accounting policy.
F-62
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
All financial assets relate to cash and cash equivalents and trade and other receivables prior to January 1, 2018. The group stated all of these assets at their recoverable amounts which approximated to fair value due to their short-term nature.
Impairment
The group assesses on a forward-looking basis the expected credit loss associated with its debt instruments carried at amortized cost. The impairment methodology applied depends on whether there has been a significant increase in credit risk. For trade receivables the group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognized from initial recognition of the receivables. Management determines the classification of its financial assets and liabilities at initial recognition.
The loss allowances for financial assets are based on management assumptions about risk of default and expected loss rates. Management uses judgment in making these assumptions and selecting inputs to impairment calculations based on past history, external conditions and forward-looking estimates.
The group does not use derivative instruments to reduce the exposure to foreign exchange risk.
ii. Financial liabilities
Financial liabilities held at fair value through profit or loss comprise convertible notes which are dealt with in the specific accounting policy (note 2.14).
Financial liabilities at amortized cost include trade payables, lease liability and Other payables excluding non-financial liabilities. Trade payables are initially recognized at the amount required to be paid. Subsequently, trade payables are measured at amortized cost, which approximates the fair value due to the short-term nature of these liabilities.
Borrowing costs primarily comprise interest on borrowings from banks and other financial institutions. All borrowing costs are expensed in the period in which they are incurred. Note 2.14 sets out the accounting policy for bank debt and other borrowings.
2.10 Offsetting financial instruments
Financial assets and liabilities are reported at their net amount in the consolidated statements of financial position if there is a legally enforceable right of offset and there is an intention to settle. The legally enforceable right must not be contingent on future events and must be enforceable in the normal course of business and in the event of default, insolvency or bankruptcy of the group or the counterparty.
2.11 Trade and other receivables
Financial assets included in trade and other receivables are recognized initially at fair value. The group holds these receivables with the objective to collect the contractual cash flows and therefore measures them subsequently at amortized cost using the effective interest method, less any impairment losses.
2.12 Cash and cash equivalents
Cash and cash equivalents comprise cash on hand and demand deposits and other short-term and highly liquid investments that are readily convertible to a known amount of cash and are subject to an insignificant risk of changes in value with original maturities of three months or less.
2.13 Equity
Share capital
The groups share capital is made up of share quotas representing a shareholding in the nominal amount subscribed for by the relevant shareholder. The shares have equal voting rights with each £0.01 of nominal
F-63
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
amount subscribed for representing one vote. As of December 31, 2019, the parent Companys share capital was divided on a contractual basis pursuant to a shareholders agreement into common shares and common shares with contractual preference rights. These common shares with contractual preference rights have a liquidation preference over other common shares. In addition, common shares with contractual preference rights have an anti-dilution protection that is not applicable for other common shares. Pursuant to United Kingdom law, no holder of these common shares with contractual preference rights could require the parent Company to pay cash, a financial asset or a variable number of the parent Companys shares. Therefore, the common shares with contractual preference rights are classified as equity.
Other reserves
Other reserves consist of the value of consideration paid in the form of equity shares granted in F-star Therapeutics Limited for the acquisition of subsidiaries, above the nominal value, less the value of consideration paid for Delta, which eliminates on consolidation.
Retained earnings/accumulated losses
Retained earnings, or accumulated losses, include all current period retained profits and losses including gains and losses arising from share-based payments.
2.14 Borrowings
Convertible notes designated at FVPL
The group has convertible notes with embedded derivatives. As the host contract is not an asset within the scope of IFRS 9 Financial Instruments and the embedded derivative significantly modifies the cash flows that otherwise would be required by the contract, the Company has elected to classify the instrument as a liability in its entirety. The instrument has been designated as at fair value through profit or loss on initial recognition and, as such, the embedded conversion feature is not separated. The convertible note is remeasured to fair value at each reporting date and changes in carrying value are recognized in profit or loss.
All transaction costs related to financial instruments designated as at fair value through profit or loss are expensed as incurred.
Borrowings are removed from the balance sheet when the obligation specified in the contract is discharged, cancelled or expired. The difference between the carrying amount of a financial liability that has been extinguished or transferred to another party and the consideration paid, including any non-cash assets transferred or liabilities assumed, is recognized in profit or loss as other income or finance costs.
Borrowings are classified as current liabilities unless the company has an unconditional right to defer settlement of the liability for at least twelve months from the date of the consolidated statements of financial position.
2.15 Trade and other payables
Trade and other payables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payable are classified as current liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities.
Deferred revenue
Payments for unsatisfied performance obligations to be completed in future periods are recorded in the consolidated statements of financial position as contract liabilities (deferred revenue).
F-64
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
2.16 Current and deferred income tax
The tax credit/charge represents the sum of the tax currently receivable/payable and deferred tax. The tax currently payable/receivable is based on taxable profit/loss for the year. Taxable profit/loss differs from net profit/loss as reported in the consolidated statements of comprehensive income because it excludes items of income or expense that are taxable or deductible in other years and it further excludes items that are never taxable or deductible. The groups asset/liability for current tax is calculated using tax rates that have been enacted or substantively enacted by the date of the consolidated statements of financial position.
R&D expenditure is expensed in the year in which it is incurred unless development costs meet the criteria for capitalization (see note 2.7). Any tax credit receivable under the small company R&D scheme is recognized in Income tax in the consolidated statements of comprehensive income.
Deferred tax is the tax expected to be payable or recoverable on differences between the carrying amounts of assets and liabilities in the consolidated financial statements and the corresponding tax bases used in the computation of taxable profit and is accounted for using the balance sheet liability method. Deferred tax liabilities are generally recognized for all taxable temporary differences and deferred tax assets are recognized to the extent that it is probable that taxable profits will be available against which deductible temporary differences can be utilized. Such assets and liabilities are not recognized if the temporary difference arises from the initial recognition of goodwill or from the initial recognition (other than in a business combination) of other assets and liabilities in a transaction, which affects neither the taxable profit nor the accounting profit.
Deferred tax liabilities are recognized for taxable temporary differences arising on investments in subsidiaries except where the company is able to control the reversal of the temporary difference and it is probable that the temporary difference will not reverse in the foreseeable future.
The carrying amount of deferred tax assets is reviewed as of the date of the consolidated statements of financial position and reduced to the extent that it is no longer probable that sufficient taxable profits will be available to allow all or part of the asset to be recovered.
Deferred tax is calculated at the tax rates that are expected to apply in the period when the liability is settled, or the asset is realized. Deferred tax is charged or credited in the consolidated statements of comprehensive income, except when it relates to items charged or credited directly to equity, in which case the deferred tax is also dealt with in equity.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to set off current tax assets against current tax liabilities and when they relate to income taxes levied by the same taxation authority and the group intends to settle its current tax assets and liabilities on a net basis.
2.17 Post-employment benefits
The group pays contributions to defined contribution plans. The costs charged against profits represent the amount of the contributions payable to the scheme in respect of the accounting period.
2.18 Share-based payments
F-star Therapeutics Limited, the parent company of the group, operates an equity-settled, share-based compensation plan, under which it issues equity instruments (share options) of the parent company to employees, consultants and board members of the group. The fair value of the services received in exchange for the grant of the options is recognized as an expense. The total amount to be expensed is determined by reference to the fair value of the options granted, excluding the impact of any service and non-market performance vesting conditions.
Non-market performance and service conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all the
F-65
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
specified vesting conditions are to be satisfied. At the end of each reporting period, the group revises its estimate of the number of options that are expected to vest based on the non-market vesting and service conditions. It recognizes the impact of the revision to original estimates, if any, in the consolidated statements of comprehensive income, with a corresponding adjustment to equity. The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model.
2.19 Revenue recognition
The groups revenues are generated through its collaborative arrangements with two external collaborators. The terms of the arrangements with the external collaborators include performing R&D services and the grant of intellectual property rights. In exchange for the initial grant of intellectual property rights and R&D services, the group has received non-refundable upfront license payments and is eligible to receive variable consideration in the form of milestone payments that are based on the achievement of defined collaboration objectives.
On inception of a new contract, management identifies performance obligations and considers if these performance obligations are distinct. Performance obligations are promised services in a contract to transfer a distinct service to the customer. Promised services are considered distinct when: (i) the customer can benefit from the service on its own or together with other readily available resources, and (ii) the promised service is separately identifiable from other promises in the contract. In assessing whether promised services are distinct, management considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, management considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
For customer options to acquire intellectual property rights, management assesses if the optional future services are offered at the standalone selling price. If this is the case, then the option is not deemed to provide the customer with a material right and is not considered to be a separate performance obligation. In determining the standalone selling price management consider factors such as identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until the option is exercised or expires, whichever is earliest.
Management estimates the transaction price based on the amount of consideration that the group expects to receive for transferring the promised services in the contract and allocates the transaction price to each performance obligation based upon managements estimate of the standalone selling price. Management must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. Management utilizes key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts the group would expect to receive for each performance obligation.
For variable consideration, the group assesses the likelihood that a significant reversal of cumulative revenue will not occur, and amounts are recognized only if it is deemed to be highly probable that reversal will not occur. The group utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration expected to be received.
For arrangements that include sales-based royalties and sales-based milestones and in which the license is deemed to be the predominant item to which the royalties relate, F-star recognizes royalty revenue upon the later
F-66
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
For R&D services, the customer pays the fixed amount based on a payment schedule. If the services rendered by the group exceed the payment received, a contract asset is recognized. If the payments exceed the services rendered, a contract liability (deferred revenue) is recognized.
For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable. When R&D services income, license fees and milestone income are recognized over time, resource expended to date is used as the measure of progress of the performance obligations identified in the contract for the following reasons:
|
each performance obligation contains multiple deliverables; and |
|
resource expended has been assessed as the most accurate method of measuring progress towards completion of each performance obligation. |
Revenue generated on derecognition of intangible assets
A judgement exists as to whether the income generated from the exclusive, perpetual license of intellectual property which results in the derecognition of an intangible asset should be recognised as revenue under IFRS 15 Revenue from contracts with customers, or as other income. In making this assessment, management has also considered the recent June 2020 IFRS Interpretations Committee Agenda Decision on Player Transfer Payments (IAS 38 Intangible Assets) and the potential implications of this on accounting for income in the biotechnology sector where an intangible asset has been de-recognized.
Management has assessed the substance of the groups transactions and concluded that the exclusive, perpetual license of intellectual property should be recognised under the licensing guidance in IFRS 15. The business model of the group, which includes the development and licensing of intellectual property (such that selling intangible assets is not considered an ancillary activity), allows F-star to conclude that the application of the licensing guidance under IFRS 15 is the most relevant. Income from the exclusive, perpetual licensing of intellectual property is therefore recognised within Revenue in the consolidated statement of comprehensive (loss)/income, with the derecognised intangible asset recognised in Costs related to collaborative arrangements (see note 2.20).
2.20 Costs related to collaborative arrangements
Costs related to collaborative agreements include all costs incurred which are directly attributable to the research and development activities which generate revenue under F-stars license and collaboration agreements. Where revenue includes the license of perpetual, exclusive intellectual property rights for in-process research and development that has been capitalized, an appropriate amount is charged to the consolidated statement of comprehensive (loss)/income, based on an allocation of cost or value of the rights that have been licensed, which corresponds to the amount of the intangible asset derecognized from the balance sheet. Cost related to collaborative agreements also include FTE costs and external R&D costs (for subcontracted research and development activities), that have directly derived revenue, and amortization of capitalized intellectual property rights that have been acquired for the purpose of fulfilling the groups obligations under its License and Collaboration agreements.
2.21 Leases
The group leases offices for a fixed period of 3 to 5 years. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. The lease agreements do not impose any covenants other than the security interests in the leased assets that are held by the lessor. Leased assets may not be used as security for borrowing purposes.
F-67
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
On inception of any contract, management assesses whether that contract is, or contains, a lease. A contract is deemed to be, or deemed to contain, a lease, if the contract gives the group the right to control the use of an asset. To determine this, management assesses if:
|
The contract involves the use of an identified asset |
|
The group has the right to obtain substantially all of the economic benefits from the use of the asset throughout the period of use; and |
|
The group controls the use of the asset, which can be indicated by either: |
|
The group having the right to operate the asset. |
|
The group having designed an asset in a way which predetermines how it will be used and for what purpose. |
Where a contract is deemed to be, or is deemed to contain, a lease, the group recognizes a right-of-use asset and a lease liability.
The right-of-use asset is initially measured at cost, which comprises the initial amount of the lease liability, adjusted for any lease payments made at or before the commencement date, plus any initial direct costs incurred and an estimate of costs to dismantle, remove or restore the underlying asset, less any lease incentives received. Right-of-use assets are generally depreciated over the shorter of the assets useful life and the lease term on a straight-line basis. If the group is reasonably certain to exercise a purchase option, the right-of-use asset is depreciated over the underlying assets useful life.
The lease liability is initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using the interest rate implicit in the lease, or if that rate cannot be readily determined, the groups incremental borrowing rate, being the rate that the individual lessee would have to pay to borrow the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar economic environment with similar terms, security and conditions. For all current leases the group has used the incremental borrowing rate as the discount rate. The liability is measured at amortized cost, using the effective interest method and remeasured when there is a change in future lease payments. When the liability is remeasured, a corresponding adjustment is made to the carrying amount of the right-of-use asset or recorded in the consolidated statement of comprehensive (loss)/income if the carrying amount of the right-of-use asset has been reduced to zero.
The group is exposed to potential future increases in variable lease payments based on an index or rate, which are not included in the lease liability until they take effect. When adjustments to lease payments based on an index or rate take effect, the lease liability is reassessed and adjusted against the right-of-use asset.
Lease payments are allocated between principal and finance cost. The finance cost is charged to the profit and loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period.
Short-term leases and leases of low-value assets
The group has elected not to recognize right-of-use assets and lease liabilities for short-term leases of office buildings that have a lease term of 12 months or less and leases of low-value assets, such as office equipment. The group recognizes the lease payments associated with these leases as an expense on a straight-line basis over the lease term.
F-68
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
3. Financial risk management
3.1 Group financial risk factors
Foreign exchange risk
The group undertakes transactions denominated in foreign currencies and as such is exposed to price risk due to fluctuations in foreign exchange rates. The group does not use derivative instruments to reduce exposure to foreign exchange risk.
Currency risk is the risk that the changes in foreign exchange rates will cause fluctuations in the fair values and cash flows of the groups financial instrument holdings. Foreign exchange risk arises when future recognized assets or liabilities are denominated in a currency that is not the entitys functional currency.
The group considers its currency risk to be moderate and states the following net position of financial asset/ (liability) held in foreign currencies as at December 31, 2019 and December 31, 2018
December 31, 2019 £ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
U.S. dollars |
2,414,595 | 83,088 | 238,700 | |||||||||
Pounds sterling |
37,795 | | | |||||||||
Euros |
51,887 | 5,265,362 | 47,465 | |||||||||
Swiss Francs |
(230,988 | ) | | |
The following table illustrates the sensitivity of the change in cash and trade and other receivables and trade and other payables and the net profit (loss) for the period and equity to a reasonably possible change in exchange rates of 10%, with effect from the beginning of the period. These changes are considered to be reasonably possible based on the observation of current market conditions. The calculations are based on the groups financial instruments held at each date of consolidated statements of financial position. All other variables are held constant. Effect on net result of the year/equity:
December 31, 2019 £ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
Exchange rate +10% |
||||||||||||
U.S. dollars |
(219,509 | ) | (7,553 | ) | (27,100 | ) | ||||||
Pounds sterling |
(3,436 | ) | | | ||||||||
Euros |
(4,717 | ) | (478,699 | ) | (4,315 | ) | ||||||
Swiss Francs |
20,999 | | |
Interest rate risk
Interest rate risk is the risk that the changes in market interest rates will cause fluctuations to the fair values and cash flows of the groups financial instrument holdings. The groups only borrowings are in the form of convertible notes which have fixed interest rates and the interest generated from bank deposits is immaterial. Therefore, management does not consider the group to have any sources of risk due to fluctuation in market interest rates.
Credit risk
Credit risk is the risk of financial loss to the group if the counterparty fails to meet its obligations. Credit risk arises from the groups operating activities from receivables, financing activities from cash and cash equivalents and deposits with banks and financial institutions.
The group has two external customers. The group closely monitors the performance conditions under the contract with the customer ensuring that invoices are raised when performance conditions are met and that the payments terms with the customer are adhered to.
F-69
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
The % of annual revenue generated from agreements with each customer for the years ended December 31, 2019, 2018 and 2017 are as follows:
Customer |
Year ended December 31, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
|||||||||
Merck |
91 | % | 100 | % | 100 | % | ||||||
Denali |
9 | % | | |
Credit risk from trade and other receivables is minimized by establishing credit policies such as monitoring procedures to recover overdue customer accounts and to assess impairment. These balances are written off when there is no reasonable expectation of recovery. Indicators of this would include failure of a debtor to engage with a repayment plan with the Company and failure to make contractual payments for a period of greater than 120 days past due.
The group applies the IFRS 9 simplified approach to measuring expected credit losses, which uses a lifetime expected loss allowance for all trade receivables. The expected loss rates are based on the payment profile of the groups two customers over the trading period. The historical loss rate is zero but has been adjusted to reflect current and forward-looking information on macroeconomic factors affecting the ability of the customer to settle the receivable. There are no trade receivables due from the groups customers at December 31, 2018 or December 31, 2019 and therefore no impairment loss has been recognised at either reporting date.
Credit risk from financing activities is minimized by establishing investment policies in liquid securities with high credit ratings and maintaining accounts in reputable financial institutions with high quality credit ratings. All cash held by the group is with financial institutions with a credit rating of F1+ or AA- according to Fitchs short term and long-term credit ratings. Due to the short-term nature of the groups cash deposits the expected credit losses are deemed to be immaterial by management.
While cash and cash equivalents and recoverable VAT (other receivables) are also subject to the impairment requirements of IFRS 9 the identified impairment loss was immaterial.
Liquidity risk
Liquidity risk is the risk that the group will encounter difficulty in meeting its short-term obligations associated with financial liabilities.
Liquidity needs are monitored by the group using rolling forecasts to determine if it has sufficient funds to meet its liabilities when due, under normal and unexpected conditions, without incurring unacceptable losses.
As of the signing date of these consolidated financial statements for the year ended December 31, 2019, the group will require additional financing to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of these financial statements (see note 2.2).
F-70
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
The table below analyses the groups financial liabilities (interest included) into relevant maturity groupings based on the remaining period at the consolidated statements of financial position date to the contractual maturity date.
December 31, 2019 £ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
Payable in less than one year |
||||||||||||
Borrowings |
11,571,021 | | | |||||||||
Other payables |
10,621,957 | 1,555,382 | 1,341,879 | |||||||||
Lease liability |
465,060 | | | |||||||||
|
|
|
|
|
|
|||||||
22,658,038 | 1,555,382 | 1,341,879 | ||||||||||
|
|
|
|
|
|
|||||||
Payable in one to two years |
||||||||||||
Lease liability |
39,910 | | | |||||||||
|
|
|
|
|
|
|||||||
39,910 | | | ||||||||||
|
|
|
|
|
|
|||||||
Impact of discounting non-current liabilities |
(165 | ) | | | ||||||||
|
|
|
|
|
|
|||||||
Total financial liabilities |
22,697,783 | 1,555,382 | 1,341,879 | |||||||||
|
|
|
|
|
|
3.2 Fair value estimation
The group has unlisted investments and convertible notes measured at fair value with level 3 inputs as at December 31, 2019. The group intangible assets were initially measured at fair value on May 7, 2019, the date of acquisition. See note 16 for disclosures in respect of unlisted investments and note 21 for disclosures in respect of convertible notes. No other financial instruments are measured at fair value.
The different levels have been defined as follows:
|
Quoted prices (unadjusted) in active markets for identical assets or liabilities (Level 1) |
|
Inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) (Level 2) |
|
Inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs) (Level 3) |
The groups finance team performs valuations of financial items for financial reporting purposes, including Level 3 fair values, in consultation with third party valuation specialists for complex valuations. Valuation techniques are selected based on the characteristics of each instrument, with the overall objective of maximizing the use of market-based information. The finance team reports directly to the chief financial officer (CFO) and any significant fair value changes at each reporting date are discussed with the CFO.
4. Critical accounting estimates and judgments
Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances.
The group makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are addressed below.
In the application of the groups accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources.
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Notes to the Consolidated Financial Statements
The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the year of the revision and future years if the revision affects both current and future years.
Key judgments and sources of estimation uncertainty relating to these consolidated financial statements are:
4.1 Corporate reorganization, business combination and asset acquisition judgment as to identification of accounting acquirer
On May 7, 2019, F-star Therapeutics Limited acquired 100% of the issued share capital of F-star Alpha Limited, F-star Beta Limited, F-star Delta Limited and F-star Biotechnologische Forschungs und Entwicklungsges.m.b.H via share for share exchange.
From a legal perspective F-star Therapeutics Limited is the acquirer in this transaction. However, in accordance with IFRS 3, management were required to assess which entity met conditions for designation as the accounting acquirer. Taking the following considerations into account, management determined that the accounting acquirer is F-star Delta Limited:
|
The former shareholding in F-star Delta Limited was exchanged for the largest proportion of shares in the combined company |
|
The fair value of the assets of F-star Delta Limited is the largest of the entities involved in this transaction |
As a result of the above assessment the financial statements for the comparative year ended December 31, 2018 represent the substance of the corporate reorganization and are those of F-star Delta Limited.
4.2 Corporate reorganization, business combination and asset acquisition judgment in relation to the classification of acquirees as a business or asset
The determination of whether a transaction results in the acquisition of a business or an asset can be judgmental. Management considered a number of factors to determine whether the acquisition of GmbH, Alpha and Beta should each be accounted for as a business combination in accordance with IFRS 3 Business Combinations or an asset acquisition in accordance with IFRS 2 Share-Based Payments. The current definition of a business from IFRS 3 states that a business consists of inputs and processes applied to the inputs that have the ability to create outputs.
These judgments were based on the following considerations for each entity:
|
Alpha holds the intellectual property rights for one early stage clinical molecule, which is not currently being developed. It has no income streams, other than interest income earned on loans to other F-star group entities. Alpha does not employ an organized workforce and does not currently utilize one via any contractual arrangements. In the absence of processes and the ability to generate outputs, the acquisition of Alpha was deemed by management to be an asset acquisition |
|
Beta holds the intellectual property rights for several early discovery stage assets and two preclinical assets. Although Beta does not employ its own workforce it has a contracted right to access the workforce of GmbH or the ability to contract with other workforces and has the ability to create outputs via partnering or collaboration arrangements and so was deemed to be a business by management. |
|
GmbH holds the intellectual property rights for several non-immuno-oncology assets that are being developed under a collaboration agreement with a partner. GmbH employs its own workforce and the ability to create outputs and as such was deemed a business by management. |
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
4.3 Corporate reorganization, business combination and asset acquisition consideration (accounting estimate)
The consideration for the acquisitions of Alpha, Beta, Delta and GmbH was entirely in the form of issued share capital of FTL. In order to determine the value of the consideration, the fair value of the issued equity or asset acquired in each transaction was determined and was deemed to be equal to the fair value of the consideration paid for the issued equity or asset. The valuation of the issued equity or assets acquired required estimates and judgments by management and these are described more fully in the intangible assets section of this note and in note 26.
4.4 Judgments and estimates utilized to determine the amount and timing of revenue recognition
The groups revenues are generated through its collaborative arrangements with two external collaborators. The following sections provide information regarding the nature and timing of the satisfaction of performance obligations under the contracts into which the group has entered, which requires management to make significant estimates and judgments as described.
License and collaboration agreement with Denali Therapeutics Inc.
The group has a License and Collaboration Agreement with Denali Therapeutics Inc. (Denali) under which it supplies intellectual property rights, the option to acquire further rights and R&D services to develop a number of therapeutic molecules. The group is also eligible to receive milestone payments if certain stages of development, regulatory approval and annual product sales are achieved. The contract includes multiple obligations, however the intellectual property licensing and R&D services supplied are not deemed to be separate performance obligations. This is because the intellectual property rights granted are expected to be significantly modified by the R&D services also provided by the group.
The option to acquire further rights is not considered to be a material right, as the option does not provide Denali with a discount that it would not have otherwise received. This is therefore deemed to not be a separate performance obligation.
Revenue from the grant of intellectual property rights and R&D services provided as part of this arrangement is recognized using the cost-to-cost method to measure progress of completion of the performance obligation, which utilizes the total cost of labor incurred to the reporting date, relative to the total expected cost as estimated by management. Success-based milestones represent variable consideration which is included in the transaction price only when it is highly probable that a significant reversal of cumulative recognized revenue will not occur.
Standard payment terms of the contract are payment within 30 days.
2019 License and collaboration agreement with Ares Trading S.A. (Merck KGaA)
The group has a License and Collaboration Agreement with Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany (Ares), under which it supplies R&D services and grants options to license intellectual property rights to two immuno-oncology therapeutic molecules. The group also receives milestone payments if certain stages of development are achieved.
Each molecule for which R&D services and the option to acquire intellectual property rights is provided is considered by management to be a separate performance obligation, as the services and intellectual property relating to the each of the two molecules can be provided separately from the other molecule. Management considered the allocation of the transaction price to each molecule included in the agreement and determined that the contracted price for each molecule was equivalent to the standalone selling price of each.
When considering the performance obligations for each molecule, the option to license intellectual property granted was not considered to be a material right, as the option does not provide Ares with a discount that it
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
would not have otherwise received. This is therefore deemed not to be a separate performance obligation from the R&D services provided for each of the two molecules included in the agreement.
The License and Collaboration Agreement includes both fixed and variable consideration. At inception of the contract, management evaluated the total amount of consideration and the likelihood that each payment would be received. The amount included in the transaction price was constrained to the amount for which it is highly probable that a significant reversal of cumulative revenue recognized will not occur. At each reporting period management evaluates whether milestones are considered highly probable of being reached and, to the extent that a significant reversal would not occur in future periods, estimate the amount to be included in the transaction price using the most likely amount method. There are no provisions in the existing agreement for returns or refunds.
Management assessed the agreement and does not believe there is a significant financing component. Standard payment terms of the contract are payment within 45 days.
2017 License and collaboration agreement with Ares Trading S.A. (Merck KGaA)
Prior to the execution of the 2019 License and collaboration agreement with Ares Trading S.A (as described in the previous section) there was a pre-existing agreement in place, which was terminated on May 13, 2019.
The previous agreement provided Ares Trading with R&D services for the development of five drug candidates, and the grant of intellectual property rights which gave Ares the ability to evaluate the drug candidate data and work plans. Ares Trading S.A also had the option to acquire the entire issued share capital of F-star Delta Limited.
Management determined that the R&D services and transfer of intellectual property rights constituted a single performance obligation. All performance obligations relating to this contract were deemed to have been fully settled by May 13, 2019 and there is no future revenue to be recognized in relation to this contract.
The selling price of the new intellectual property rights granted under the 2019 agreement was assessed by management to be equivalent to the standalone selling price. The 2019 agreement has therefore been accounted for as a separate contract, rather than a modification of this existing contract.
4.5 Fair value of derivatives and other financial instruments key estimates
The fair value of financial instruments that are not traded in an active market is determined by using valuation techniques.
Convertible loan notes containing embedded derivatives
The inputs into the fair value calculations of the convertible notes are classified as level 3 fair values in the fair value hierarchy due to the use of unobservable inputs, including own credit risk.
The initial fair value of the convertible notes designated at FVTPL has been determined as the transaction price, as this is deemed to be at arms length in accordance with the guidance set out in IFRS 13. In determining the fair value on subsequent measurement, the group uses its judgment to estimate the probability of the manner in which the group will raise additional funding in the future, which in turn determines the conversion price and value of the derivative embedded in the convertible notes. Fair value was determined using a weighted average percentage probability of various possible scenarios. The key assumption in calculating the fair value of the embedded derivative as at December 31, 2019 was the probability of securing Series B financing of 90% with the balance of probability allocated to no funding and redemption on expiry (in which case the value of the derivative is zero).
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
The fair value of the embedded derivative if the key assumption were to change by 10% whilst all other assumptions remain constant would be as follows:
Increase probability by 10%: |
£ | 407,438 | ||
Decrease probability by 10%: |
£ | (407,438 | ) |
4.6 Fair value of share-based compensation key estimates
A share option compensation charge has been recognized in respect of share options granted. There are a number of subjective inputs into the calculation of the charge, the most significant of which is the share price on the date of grant. As an unlisted company this is subject to a significant degree of estimation uncertainty. Management estimate the share price by engaging an independent valuer to assess the fair value of the total equity of the group at the date of grant. This is done by valuing the assets and liabilities of the group on either a cost approach or by modelling of the net present value of the future discounted cash flows, depending on whether the asset is being developed by the group with intention to sell or developed under a collaboration agreement with the intention to receive future milestone and royalty payments.
4.7 Delta intangible assets key estimates
Useful life of intangible assets
In the prior period Delta acquired intangible assets that consist of intellectual property rights from a third party that have been sub-licensed to its one external customer. Delta is designated the accounting acquirer; therefore these have been included in the consolidated financial statements on a carry-over basis. Management estimate the useful life of each asset to be the life of the underlying patents that relate to each asset. However, the actual economic life may be longer than estimated due to potential regional patent term extensions, which are currently unknown.
Impairment of intangible assets
Management assesses whether acquired intangible assets have suffered any impairment at each reporting date. For the current and prior year, the recoverable amount of these assets was determined based on value-in-use and fair value less cost of disposal calculations, which requires the use of assumptions and estimates. For assets that are not the subject of partnering agreements the calculations include a cost approach, which utilised net amount invested with a return on investment commensurate with the achievement of certain value inflection events. For partnered assets the calculations include cash flow projections based on financial budgets approved by management covering a three-year period.
Cash flows beyond the three-year period are forecasted using published transition probabilities for development of biological therapeutic molecules, expected clinical study design based upon the clinical development strategy for the pipeline assets and industry analyst sales and gross margin projections for similar molecules in the same target indications.
In the year ended December 31, 2019, due to strategic changes in the asset development plans, a combination of discounted cash flow and cost approach methodologies (employing a return on investment model) have been used to assess the value-in-use and fair value less cost of disposal for intangible assets. The valuation methodology for FS118 and FS131 changed from discounted cash flow in the year ended December 31, 2018 to a cost approach methodology for the year ended December 31, 2019 due to a change from partnered development to wholly owned asset during the year ended December 31, 2019.
Partnered assets discounted cash flow approach
The key assumption used in the value-in-use calculations were as follows:
2019 | 2018 | 2017 | ||||||||||
Discount factor |
13.0 | % | 13.5 | % | 13.5 | % |
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
The recoverable amount would equal the carrying amount if the key assumption was to change as follows:
2019 | 2018 | |||||||||||||||
Discount factor | From | To | From | To | ||||||||||||
Asset 1 (FS118)1 |
N/A | N/A | 13.5 | % | 16.4 | % | ||||||||||
Asset 2 (FS231)/(FS220)2 |
N/A | N/A | 13.5 | % | 14.7 | % | ||||||||||
Asset 3 (FS122)3 |
N/A | N/A | 13.5 | % | 14.7 | % | ||||||||||
Asset 4 (FS422)/(FS129) |
13.0 | % | 22.9 | % | 13.5 | % | 14.3 | % | ||||||||
Asset 5 (FS131)2 |
N/A | N/A | 13.5 | % | 14.3 | % |
1 |
See Non-partnered assets cost approach section below for key assumptions used in the fair value less cost of disposal calculation for this asset. |
2 |
Asset was fully impaired during the current year see note 13. |
3 |
Asset was derecognized in the current year see note 13. |
The other assumptions used in the estimation of the recoverable amount are as set out below:
|
The values assigned to the assumptions represented the directors assessment of the future trends in the relevant industry and have been based on historical data from both external and internal sources. |
|
The discount rate was estimated based on cost of equity and cost of debt. |
|
The cash flow projections included specific development estimates including cost of sales, cost of research & development, probability of success and amount and timing of projected future revenue. |
Non-partnered assets cost approach
The key assumptions used in the value-in-use and fair value less cost of disposal calculations were as follows:
Key assumption
FS118 | ||||
Obsolescence factor |
||||
2019 investment |
30 | % | ||
2018 investment |
40 | % | ||
2017 investment |
40 | % | ||
Value inflection events |
||||
Investigational New Drug (IND) application approval |
5 | % | ||
Phase 1 commencement |
10 | % | ||
Partnering renegotiation |
5 | % |
The recoverable amount would equal the carrying amount if a negative inflection event of 45% were to have occurred in the year ended December 31, 2019. There is no reasonably possible movement in obsolescence in the current year that could result in an impairment.
Management has determined the values assigned to each of the above key assumptions as follows:
Assumption | Approach to determining values | |
Obsolescence factor | This relates to the cost incurred on an asset in a given year which has been discounted for an estimate of non-productive spend in that year (i.e. expenditure which has not been deemed to have increased the value of the asset). Management assessed this by examining all activities carried out in each year and determining the productivity of each activity. | |
Value inflection event | These are events that would result in an increase or decrease of the value of an asset. Publicly traded comparable companies were identified that experienced similar events and the equity value was calculated one-day prior to the associated news release, as well as one-day, five-days, 10-days and 30-days post news release to measure the increase or decrease in value. |
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
4.8 Intangible assets acquired on acquisition Beta and GmbH
Fair value of acquired intangible assets as at the date of acquisition
The table below lists the assets acquired on consolidation, the type of asset acquired and the methodology used to estimate the fair value at the date of acquisition.
The settlement of pre-existing rights and contracts between the acquired entities and Delta did not result in any settlement gains or losses, but resulted in the addition of £23.5 million intangible assets (see note 13) in addition to the assets acquired with Beta and GmbH as listed below.
Beta
Asset | Asset Type | Method used to estimate recoverability | ||
FS21 | Partnered asset | NPV of probability adjusted future cash flows | ||
FS120 | Non-partnered assets | Cost approach | ||
FS222 | Non-partnered assets | Cost approach |
GmbH
Asset | Asset Type | Method used to estimate recoverability | ||
Partnered Neuroscience assets | Partnered asset | NPV of probability adjusted future cash flows |
The key assumptions used in the fair value calculations as at May 7, 2019 are as follows:
Partnered assets discounted cash flow approach
Discount factor 13.5%
Non-partnered assets cost approach
Key assumption
FS120 | FS222 | |||||||
Obsolescence factor |
||||||||
2019 investment |
30 | % | 25 | % | ||||
2018 investment |
40 | % | 90 | % | ||||
2017 investment |
40 | % | 99 | % | ||||
Value inflection events |
||||||||
Candidate selection |
3 | % | 3 | % | ||||
Manufacturing process determined |
12.5 | % | 12.5 | % |
Useful life of intangible assets
For intangible assets that relate to Intellectual Property licensing, management estimates the useful life of the assets to be the life of the underlying patents. However, the actual economic life may be longer than estimated due to potential regional patent term extensions which are currently unknown. For contracted cash flows, management have estimated the useful life as the length of time substantially all of the economic benefit of the asset is forecasted to flow to the group.
Impairment of intangible assets
Management perform impairment assessment for intangible assets with indefinite life at each reporting date, or sooner if there is an indication that the asset may be impaired. For intangible assets under amortization, they are tested for impairment if an indicator is identified. For the year ended December 31, 2019 the recoverable amount
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
of these assets was determined based on value-in-use calculations or fair value less cost of disposal, which requires the use of assumptions and estimates and a cost approach, which utilized net amount invested with a return on investment commensurate with the achievement of certain value inflection events.
The same methodology was used to estimate the value-in-use or fair value less cost of disposal for each asset at December 31, 2019 as was used to calculate the fair value at the date of acquisition (as per the table in the previous section of this note).
Partnered assets discounted cash flow approach
In the current year, management have assessed reasonably possible changes for key assumptions included in the impairment model and have concluded that there are no instances that would impact the carrying value of the intangible assets as at December 31, 2019, with the exception of FS21 which was fully impaired during the year.
The key assumptions used in the value-in-use calculations for the year ended December 31, 2019 are as follows:
|
Discount factor: 13.0% |
The key assumptions used in the estimation of the recoverable amount are as set out below:
|
The values assigned to the key assumptions represented managements assessment of the future trends in the relevant industry and have been based on historical data from both external and internal sources. |
|
The discount rate was estimated based on cost of equity and cost of debt. |
The cash flow projections included specific development estimates including cost of sales, cost of R&D, probability of success and amount and timing of projected future revenue.
Non-partnered assets cost approach
The key assumptions used in the fair value less costs of disposal calculations for the period ended December 31, 2019 are as follows:
Key assumption
FS120 | FS222 | |||||||
Obsolescence factor |
||||||||
2019 investment |
0 | % | 25 | % | ||||
2018 investment |
50 | % | 50 | % | ||||
2017 investment |
80 | % | 80 | % | ||||
Value inflection events |
||||||||
Candidate selection |
3 | % | 3 | % | ||||
Manufacturing process determined |
12.5 | % | 12.5 | % |
The recoverable amount would equal the carrying amount if the key assumptions were to change as follows:
FS120
The recoverable amount would equal the carrying amount if a negative inflection event of 61% or an increase in obsolescence to 70% were to have occurred in the year ended December 31, 2019.
FS222
The recoverable amount would equal the carrying amount if a negative inflection event of 52% or an increase in obsolescence to 80% were to have occurred in the year ended December 31, 2019.
4.9 Restatement of prior year deferred tax
During managements assessment of the impact of fair value adjustments of acquired intangibles on deferred taxation at December 31, 2019, it was noted that temporary timing differences that arise on the application of
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
reinvestment relief on Deltas own intangibles had not been recorded in the financial statements for the years ended December 31, 2018 or December 31, 2017.
This omission has been corrected by restating each of the affected financial statement lines for the prior periods as follows:
Statement of financial position (extract) |
December 31,
£ |
Adjustment £ |
Restated
December 31,
£ |
|||||||||
Deferred tax |
| 2,973,578 | 2,973,578 | |||||||||
Non-current liabilities |
| 2,973,578 | 2,973,578 | |||||||||
Net assets |
18,834,703 | (2,973,578 | ) | 15,861,125 |
Statement of financial position (extract) |
December 31,
£ |
Adjustment £ |
Restated
December 31,
£ |
|||||||||
Retained earnings |
18,497,771 | (2,636,737 | ) | 15,861,034 | ||||||||
Total equity |
18,497,862 | (2,636,737 | ) | 15,861,125 | ||||||||
Total equity and liabilities |
24,979,124 | | 24,979,124 |
Statement of comprehensive (loss)/income (extract) |
Year ended
£ |
Adjustment £ |
Restated
Year ended
£ |
|||||||||
Income tax credit/(charge) |
605 | (2,636,737 | ) | (2,636,132 | ) | |||||||
Profit for the financial year and total comprehensive income |
15,905,335 | (2,636,737 | ) | 13,268,598 |
Statement of financial position (extract) |
December 31,
£ |
Adjustment £ |
Restated
December 31,
£ |
|||||||||
Deferred tax |
| 336,841 | 336,841 | |||||||||
Total non-current liabilities |
2,495,919 | 336,841 | 2,832,760 | |||||||||
Net assets |
3,816,192 | (336,841 | ) | 3,479,351 |
Statement of financial position (extract) |
December 31,
£ |
Adjustment £ |
Restated
December 31,
£ |
|||||||||
Retained earnings |
3,816,101 | (336,841 | ) | 3,479,260 | ||||||||
Total equity |
3,816,192 | (336,841 | ) | 3,479,351 | ||||||||
Total equity and liabilities |
13,964,218 | | 13,964,218 |
Statement of comprehensive (loss)/income (extract) |
Year ended
£ |
Adjustment £ |
Restated
Year ended
£ |
|||||||||
Income tax credit/(charge) |
(320,023 | ) | (336,841 | ) | (656,864 | ) | ||||||
Profit for the financial year and total comprehensive income |
3,816,101 | (336,841 | ) | 3,479,260 |
4.10 Impact of change in accounting policy in prior period
The Company has adopted IFRS 15 Revenue from Contracts with Customers on a modified retrospective basis from 1 January 2018. The straight-line basis of recognition for R&D services income, which was permitted under
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
IAS 18, has been replaced with an input method to measure progress of completion of performance obligations stated in the contract. This has resulted in the following changes to the financial statements:
Statements of financial position (extract) |
IAS 18 carrying
December 31, 2017 £ |
Remeasurement £ |
IFRS 15 carrying
January 1, 2018 £ |
|||||||||
Non-current liabilities deferred revenue |
2,495,919 | 260,831 | 2,756,750 | |||||||||
Current liabilities deferred revenue |
5,990,205 | 625,993 | 6,616,198 |
The impact on the Companys retained earnings as of January 1, 2018 is as follows:
Note | £ | |||||||
Balance as of December 31, 2017 as originally stated |
3,816,101 | |||||||
Restatement of deferred tax balance |
4.9 | (336,841 | ) | |||||
Change in accounting policy (above) |
(886,824 | ) | ||||||
|
|
|||||||
Restated balance at January 1, 2018 |
2,592,436 | |||||||
|
|
5. Revenue
The group consists of a single operating reporting segment as defined under IFRS 8 Operating Segments. Revenue is derived from the transfer of goods and services over time in the following categories:
Provision of R&D services & licensing income |
Year ended
£ |
Year ended
£ |
Restated^
Year ended
£ |
|||||||||
Europe |
20,000,126 | 29,996,604 | 11,027,179 | |||||||||
U.S |
1,882,102 | | | |||||||||
|
|
|
|
|
|
|||||||
Total |
21,882,228 | 29,996,604 | 11,027,179 | |||||||||
|
|
|
|
|
|
|||||||
Timing of recognition: |
||||||||||||
At a point in time |
9,807,914 | | | |||||||||
Over time |
12,074,314 | 29,996,604 | 11,027,179 | |||||||||
|
|
|
|
|
|
|||||||
Total |
21,882,228 | 29,996,604 | 11,027,179 | |||||||||
|
|
|
|
|
|
^ |
See note 4.10 for explanation of change in accounting policy. |
Collaboration with Denali Therapeutics Inc.
In August 2016, F-star Biotechnology Limited, F-star Gamma Limited (a related party until May 30, 2018) (F-star Gamma), and F-star GmbH entered into a license and collaboration agreement (the Denali License and Collaboration Agreement) with Denali Therapeutics Inc. (Denali). The goal of the collaboration was the development of certain constant Fc domains of an antibody with non-native antigen binding activity (Fcabs), to enhance delivery of therapeutics across the blood brain barrier into the brain. The collaboration was designed to leverage F-stars modular antibody technology and Denalis expertise in the development of therapies for neurodegenerative diseases. In connection with the entry into the collaboration agreement, Denali also purchased from the F-star Gamma shareholders an option, which F-star refers to as the buy-out-option, to acquire all of the outstanding shares of F-star Gamma pursuant to a pre-negotiated share purchase agreement.
On May 30, 2018, Denali exercised such buy-out option and entered into a share purchase agreement, or the Purchase Agreement, with the shareholders of F-star Gamma and Shareholder Representative Services LLC, pursuant to which Denali acquired all of the outstanding shares of F-star Gamma, or the Acquisition.
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F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
As a result of the Acquisition, F-star Gamma has become a wholly owned subsidiary of Denali and Denali changed the entitys name to Denali BBB Holding Limited. In addition, Denali became a direct licensee of certain of the groups intellectual property (by way of Denalis assumption of F-star Gammas license agreement with the group, or the F-star Gamma License). Denali made initial exercise payments to the group and the former shareholders of F-star Gamma under the Purchase Agreement and the F-star Gamma License in the aggregate, of £13.6 million ($18.0 million), less the net liabilities of F-star Gamma, which were approximately £0.2 million ($0.2 million). Of this total, £3.0 million ($4.0 million) was payable to the group. In addition, Denali is required to make future contingent payments, to the group and the former shareholders of F-star Gamma, up to a maximum amount of £337.0 million ($437.0 million) in the aggregate upon the achievement of certain defined preclinical, clinical, regulatory and commercial milestones. Of this total, up to a maximum amount of £73.5 million ($91.4 million) is payable to the group. The total amount of the contingent payments varies based on whether F-star delivers an Fcab that meets pre-defined criteria and whether the Fcab has been identified solely by the group or solely by Denali or jointly by the group and Denali.
Collaboration with Denali Therapeutics Inc. (continued)
Under the terms of the Denali License and Collaboration Agreement, Denali has the right to nominate up to three Fcab targets for approval (Accepted Fcab Targets), within the first three years of the date of the Denali License and Collaboration Agreement. Upon entering into the Denali License and Collaboration Agreement, Denali had selected transferrin receptor, or TfR, as the first Accepted Fcab Target and paid an upfront fee of £4.1 million ($5.5 million) to F-star Gamma, which included selection of the first Accepted Fcab Target. In May 2018, Denali exercised its right to nominate two additional Fcab targets and identified a second Accepted Fcab Target. Denali made a one-time payment to the group for the two additional Accepted Fcab Targets of, in the aggregate, £4.3 million ($6.0 million) and has extended the time period for its selection of the third Accepted Fcab Target until approximately the fourth anniversary of the date of the Denali License and Collaboration Agreement.
Denali is also responsible for certain research costs incurred by the group in conducting activities under each agreed development plan, for up to 24 months.
Under the terms of the Denali License and Collaboration Agreement, the group is prohibited from developing, commercializing and manufacturing any antibody or other molecule that incorporates any Fcab directed to an Accepted Fcab Target, or any such Fcab as a standalone product, and from authorizing any third party to take any such action.
Revenue recognition
The group has considered whether the following obligations are distinct:
|
Grant of intellectual property licenses |
|
Provision of R&D services for development of the Fcabs |
Management concluded that the grant of intellectual property rights is not distinct from the provision of R&D services, as the R&D services are expected to significantly modify the early stage intellectual property. As a result, the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for this contract.
The initial transaction price for first Accepted Fcab Target was deemed to be £4.1 million which was for the grant of intellectual property rights, and £4.1 million for the second Accepted Fcab Target consisting of £2.5 million for the grant of intellectual property rights and £1.6 million for R&D services.
During the year ended December 31, 2019 the transaction price for the first accepted Fcab was increased to £5.3 million due to achievement of a £1.2 million milestone that on initial recognition of the contract was not included in the transaction price, as it was not deemed highly probable that a reversal would not occur in a future
F-81
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
reporting period. The group recognized the £1.2 million at a point in time. No other revenue was recognized for the first accepted Fcab in the year as the performance obligation identified in the contract was deemed to have been fully satisfied prior to May 7, 2019, the date of acquisition of F-star Biotechnology.
£0.7 million was recognized relating to Licensing and R&D services based on the cost-to-cost method for second Accepted Fcab Target (see note 2.19).
License and collaboration agreements with Ares Trading S.A. (Merck KGaA)
In June 2017, Delta entered into a License and Collaboration Agreement (LCA) and an Option Agreement with Ares. The purpose of the LCA was for the companies to collaborate on the development of tetravalent bispecific antibodies against five drug target pairs. The Option Agreement granted Ares a call option to acquire the entire issued share capital of Delta. Under the LCA the company was obligated to use commercially reasonable efforts to perform R&D activities on the five selected target pairs, under mutually agreed research plans. The activities were governed by a joint steering committee formed by an equal number of representatives from both parties.
On May 14, 2019, the LCA agreement with Ares was amended and restated to convert the existing purchase option over the entire share capital of Delta to an intellectual property licensing arrangement that includes the exclusive grant of development and exploitation rights to one tetravalent bispecific antibody directed against immuno-oncology targets and the option to acquire the exclusive right to an additional antibody. As part of the amended LCA, Delta now has exclusive rights to FS118, its lead product candidate, which is currently in a Phase I clinical trial. As noted in note 4 this amended and restated LCA was accounted for a separate contract, rather than a contract amendment.
For the exclusive rights granted in relation to the first molecule, an option fee of £8.6 million was paid by Ares to Delta. Following receipt of the option fee, Ares becomes responsible for the development of the molecule and development, regulatory and sales-based royalties become payable to group upon achievement of specified events. The group is eligible to receive £54.6 million (64.0 million) in development milestones and £64.0 million (75.0 million) in regulatory milestones.
For the second antibody included within the amended and restated agreement, Delta is obliged to perform research activities under plans agreed by both parties. Ares will pay for all R&D costs half-yearly in advance until the company delivers the data package specified in the research plan. Ares can then elect to pay a fee of £10.7 million (12.5 million) to exercise their option to take an exclusive intellectual property license, which allows them to control the development and exploitation of the molecule. Following receipt of the option fee, Ares is responsible for the development of the molecule and development, regulatory and sales-based royalties become payable to Delta upon achievement of specified events. Delta is eligible to receive £37.1 million (43.5 million) in development milestones and £47.0 million (55.0 million) in regulatory milestones.
Development milestone payments are triggered upon achievement by each product candidate of a defined stage of clinical development and regulatory milestone payments are triggered upon approval to market a product candidate by the FDA or other global regulatory authorities. Sales-based milestones are payable based upon aggregate annual worldwide net sales in all indications of all licensed products. The company is eligible to receive £128.1 million (150.0 million) in sales-based milestones. In addition, to the extent that any product candidates covered by the exclusive licenses granted to Ares are commercialized, the company will be entitled to receive a single digit royalty based on a percentage of net sales on a country-by-country basis.
F-82
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
Revenue recognition
The group has considered whether the following obligations are distinct:
|
Option for the grant of Intellectual Property Rights |
|
Provision of R&D services |
Management concluded that the option for the grant of intellectual property rights is not distinct from the provision of R&D services in both agreements, as the R&D services are expected to significantly modify the early stage intellectual property. As a result, the option for the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for each molecule included in this contract. The group recognizes revenue using the cost-to-cost method, which it believes best depicts the transfer of control of the services to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation.
The total transaction price for the amended and restated LCA was initially determined to be £11.9 million, consisting of the upfront payment and R&D funding for the research term. Variable consideration to be paid to the company upon reaching certain milestones has been excluded from the calculation, as it is not highly probable that a significant reversal of revenue recognized will not occur in a subsequent reporting period.
In the year ended December 31, 2019, £8.6 million Licensing and R&D services revenue for the first antibody included within the amended and restated LCA was recognized at a point in time, as no further performance obligations were identified. £1.1 million Licensing and R&D services revenue for the second antibody included within the amended and restated LCA was recognized, based on the cost-to-cost method.
In the year ended December 31, 2019, £10.3 million Licensing and R&D services revenue relating to the five antibodies included in the original LCA was recognized, based on the cost-to-cost method.
All performance obligations in the original contract were deemed to have been fully satisfied on termination of the agreement on May 14, 2019 and no further revenue is expected to be recognized.
a. Assets and liabilities related to contracts with customers
The group has recognized the following assets and liabilities related to contracts with customers:
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Deferred revenue related to upfront licensing fee, milestone income and R&D services income |
339,558 | 4,589,039 | 8,486,124 | |||||||||
|
|
|
|
|
|
F-83
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
b. Revenue recognized in relation to contract liabilities
Group deferred revenue related to upfront licensing fee, milestone income and R&D services income:
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Contract liabilities as of January 1 |
4,589,039 | 8,486,124 | | |||||||||
Adoption of new accounting standard (note 4.11) |
| 886,824 | | |||||||||
Contract assets acquired on business combination |
659,616 | | | |||||||||
Additional amounts deferred in the period |
24,815 | 1,585,398 | 8,486,124 | |||||||||
Revenue recognized in the period included in opening contract liability |
(4,589,038 | ) | (6,369,307 | ) | | |||||||
Revenue recognized in the period included in acquired contract liability |
(344,874 | ) | | | ||||||||
|
|
|
|
|
|
|||||||
Contract liabilities as of December 31 |
339,558 | 4,589,039 | 8,486,124 | |||||||||
|
|
|
|
|
|
Revenue recognized in the period not included in the opening contract liability in 2019 is £17.3 million (2018: £23.6 million, 2017: £11.0 million).
c. Unsatisfied long-term intellectual property licensing contract
The following table shows the aggregate transaction price allocated to the remaining incomplete performance obligations.
2019 £ |
2018 £ |
2017 £ |
||||||||||
Transaction price allocated to outstanding performance obligations |
3,185,408 | 10,393,242 | 28,448,480 | |||||||||
|
|
|
|
|
|
At the date of the statement of financial position, of the remaining transaction price allocated to outstanding performance obligations, 97% was expected to be recognized during 2020 and 3% during 2021. At the reporting date, all performance obligations were expected to be satisfied by February 2021. However, the impact of the COVID-19 pandemic that occurred in March 2020 on expected timelines is not currently known (note 27).
6. Costs related to collaborative arrangements
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Derecognition of intangible asset |
12,574,092 | | | |||||||||
Amortization |
621,211 | 1,083,875 | 398,290 | |||||||||
Direct labor cost |
2,274,867 | 4,823,750 | 2,304,480 | |||||||||
External R&D costs |
2,489,924 | 7,984,808 | 3,642,898 | |||||||||
|
|
|
|
|
|
|||||||
17,960,094 | 13,892,433 | 6,345,668 | ||||||||||
|
|
|
|
|
|
F-84
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
7. Other income
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Rental income |
111,289 | | | |||||||||
Interest received on overdue trade receivable balances |
1,642 | | | |||||||||
|
|
|
|
|
|
|||||||
112,931 | | | ||||||||||
|
|
|
|
|
|
8. Other gains
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Foreign exchange gains |
309,863 | 195,177 | 70,661 |
9. (Loss)/profit from operations
(Loss)/profit from operations is stated after charging:
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Charged to research and development costs: |
||||||||||||
Depreciation of property, plant and equipment |
337,126 | | | |||||||||
Amortization of intangible assets |
1,067,940 | | | |||||||||
Impairment of intangible assets |
6,608,387 | | | |||||||||
Impairment of goodwill |
298,625 | | | |||||||||
Loss on disposal of property, plant and equipment |
10,333 | | | |||||||||
Charged to general and administrative costs: |
||||||||||||
Depreciation of property, plant and equipment (including right of use assets) |
334,052 | | |
10. Employee expenses
Employee benefit expense
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Wages and salaries, including restructuring costs |
5,687,776 | | | |||||||||
Social security costs |
633,240 | | | |||||||||
Pension costs defined contribution plans |
289,512 | | | |||||||||
Share options granted to directors and employees |
2,113,097 | | | |||||||||
|
|
|
|
|
|
|||||||
Total employee benefit expense |
8,723,625 | | | |||||||||
|
|
|
|
|
|
The group operates a defined contribution scheme for the benefit of eligible employees. The assets of the scheme are administered by the trustees in funds independent from those of the member companies. The pension charge
F-85
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
represents amounts payable by the group and amounted to £289,512 for the year ended December 31, 2019 (2018 and 2017: £nil). Contributions of £3,780 (2018 and 2017: £nil) were outstanding as of the date of the consolidated statements of financial position.
Monthly average number of people employed
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Monthly average number of people (including executive directors) employed: |
||||||||||||
Research and development |
84 | | | |||||||||
Administration |
32 | | | |||||||||
|
|
|
|
|
|
|||||||
Total average headcount |
116 | | | |||||||||
|
|
|
|
|
|
Key management personnel
Prior to May 7, 2019 and the date of the reorganization, remuneration to key management was paid by a related party, F-star Biotechnology Limited. Amounts shown below relate to the allocation of remuneration which was paid by F-star Delta Limited for the years ended December 31, 2018 and 2017 and up to May 6, 2019.
Remuneration paid by the consolidated group for the period May 7, 2019 to December 31, 2019 is included in the amounts shown below for the year ended December 31, 2019.
Key management personnel (KMP) consist of the directors, Chief Financial Officer, Chief Scientific Officer, Chief Operating Officer, Chief Medical Officer and Chief Business Officer. Total remuneration for key management personnel:
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Compensation |
1,577,034 | 313,021 | 185,326 | |||||||||
Compensation for loss of office |
152,033 | 73,203 | | |||||||||
Pension contributions to money purchase pension schemes |
32,120 | 12,233 | 3,424 | |||||||||
Share-based payment expense |
1,293,281 | | | |||||||||
|
|
|
|
|
|
|||||||
3,054,468 | 398,457 | 188,750 | ||||||||||
|
|
|
|
|
|
|||||||
Number of KMP accruing benefits under defined contributions |
3 | 2 | 1 | |||||||||
|
|
|
|
|
|
11. Finance income and costs
a. Finance Income
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Interest receivable |
8,412 | 4,308 | | |||||||||
Foreign exchange gains |
| | | |||||||||
|
|
|
|
|
|
|||||||
Total finance income on financial assets measured at amortized cost |
8,412 | 4,308 | | |||||||||
|
|
|
|
|
|
F-86
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
b. Finance costs
Year ended
£ |
Year ended
£ |
Year ended
£ |
||||||||||
Bank interest payable and similar charges |
7,877 | | | |||||||||
Interest on lease liability |
22,394 | | | |||||||||
|
|
|
|
|
|
|||||||
Total finance costs on financial liabilities measured at amortized cost |
30,271 | | | |||||||||
|
|
|
|
|
|
|||||||
Interest on convertible notes |
154,491 | | | |||||||||
Foreign exchange loss |
70,792 | | | |||||||||
|
|
|
|
|
|
|||||||
Total finance cost on financial liabilities held at FVTPL |
225,283 | | | |||||||||
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|||||||
Total finance costs |
255,554 | | | |||||||||
|
|
|
|
|
|
12. Income tax (credit)/charge
a. Tax on profit
Year ended
£ |
Restated*
Year ended
£ |
Restated*
Year ended
£ |
||||||||||
Current tax: |
||||||||||||
Corporation tax (credit)/charge |
(4,934,076 | ) | 74,805 | 320,023 | ||||||||
Adjustments in respect of prior years |
| (75,410 | ) | | ||||||||
|
|
|
|
|
|
|||||||
Total current tax (credit)/charge |
(4,934,076 | ) | (605 | ) | 320,023 | |||||||
|
|
|
|
|
|
|||||||
Deferred income tax: |
||||||||||||
(Credited)/ debited to statement of comprehensive (loss)/income |
(2,082,423 | ) | 2,636,737 | 336,841 | ||||||||
|
|
|
|
|
|
|||||||
Total deferred tax benefit |
(2,082,423 | ) | 2,636,737 | 336,841 | ||||||||
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|||||||
Income tax (credit)/charge attributable to profit from continuing operations |
(7,016,499 | ) | 2,636,132 | 656,864 | ||||||||
|
|
|
|
|
|
* |
See note 4.9 for explanation of restatement of prior year deferred tax. |
F-87
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
Reconciliation of the total tax charge
The differences between the total tax shown above and the amount calculated by applying the UK standard tax rate of 19% (2018:19%, 2017: 19.25%) to the (loss)/profit before tax are as follows:
Year ended
£ |
Restated*
Year ended
£ |
Restated*
Year ended
£ |
||||||||||
(Loss)/profit before tax |
(41,975,811 | ) | 15,904,730 | 4,136,124 | ||||||||
Tax calculated at the UK tax rate of 19% (2018: 19%, 2017: 19.25%) |
(7,975,404 | ) | 3,021,899 | 796,369 | ||||||||
Tax effects of: |
||||||||||||
Expenses not deductible for tax purposes |
5,800,331 | 205,935 | | |||||||||
Additional deduction for research and development expenditure |
(4,038,288 | ) | | | ||||||||
Surrender of tax losses for R&D tax credit |
1,726,034 | | | |||||||||
Impact of reinvestment relief |
(2,552,721 | ) | (516,292 | ) | (139,505 | ) | ||||||
Differences in overseas tax rates |
17,361 | | | |||||||||
Utilization of brought forward losses |
(27,690 | ) | | | ||||||||
Losses carried forward |
35,732 | | | |||||||||
Adjustments in respect of prior years |
| (75,410 | ) | | ||||||||
Other differences |
(1,854 | ) | | | ||||||||
|
|
|
|
|
|
|||||||
Tax (credit)/charge for the year |
(7,016,499 | ) | 2,636,132 | 656,864 | ||||||||
|
|
|
|
|
|
* See note 4.9 for explanation of restatement of prior year deferred tax.
In the Spring Budget 2020, the Government announced that from April 1, 2020 the corporation tax rate would remain at 19% (rather than reducing to 17%, as previously enacted). This new law was substantively enacted on March 17, 2020. As the proposal to keep the rate at 19% had not been substantively enacted at the balance sheet date, its effects are not included in these financial statements.
b. Deferred tax
In the year ended December 31, 2019, a deferred tax liability of £2,245,790 that relates to temporary differences on fair value adjustments of acquired intangible assets arose on acquisition of Beta and GmbH. These liabilities have been netted against deferred tax assets that relate to brought forward tax losses in the same tax jurisdiction.
Unutilized
£ |
Temporary
arising on
£ |
Temporary
£ |
Share
£ |
Accelerated
capital allowances £ |
Total £ |
|||||||||||||||||||
At December 30, 2016 |
| | | | | | ||||||||||||||||||
Credited/(charged in the year) |
83,828 | | (420,669 | ) | | | (336,841 | ) | ||||||||||||||||
At December 31, 2017 (restated*) |
83,828 | | (420,669 | ) | | | (336,841 | ) | ||||||||||||||||
Credited/(charged in the year) |
| | (2,636,737 | ) | | | (2,636,737 | ) | ||||||||||||||||
At December 31, 2018 (restated*) |
83,828 | | (3,057,406 | ) | | | (2,973,578 | ) | ||||||||||||||||
Arising on acquisition of subsidiaries |
1,530,610 | (2,245,790 | ) | | 218,602 | (267,562 | ) | (764,140 | ) | |||||||||||||||
Credited in the year |
96,808 | 589,798 | 1,022,633 | 359,273 | 13,911 | 2,082,423 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
At December 31, 2019 |
1,711,246 | (1,655,992 | ) | (2,034,773 | ) | 577,875 | (253,651 | ) | (1,655,295 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
F-88
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
* |
See note 4.9 for explanation of restatement of prior year deferred tax. |
A proportion of unutilized tax losses has not been recognized by the group as a deferred tax asset due to the current uncertainty of future taxable profits. The amount of deferred taxes not recognized is £4,541,437 (2018 and 2017: £nil). These losses do not expire.
13. Goodwill and intangible assets
Goodwill £ |
Intellectual
£ |
Total £ |
||||||||||
Cost |
||||||||||||
As at December 30, 2016 |
| | | |||||||||
Additions |
| 9,846,913 | 9,846,913 | |||||||||
|
|
|
|
|
|
|||||||
As at December 31, 2017 |
| 9,846,913 | 9,846,913 | |||||||||
|
|
|
|
|
|
|||||||
Additions |
| 9,619,995 | 9,619,995 | |||||||||
|
|
|
|
|
|
|||||||
As at December 31, 2018 |
| 19,466,908 | 19,466,908 | |||||||||
|
|
|
|
|
|
|||||||
Additions |
| 100,000 | 100,000 | |||||||||
Acquired with subsidiaries (see note 26) |
3,110,452 | 13,393,627 | 16,504,079 | |||||||||
Additions due to settlement of pre-existing relationships (see note 26) |
| 23,527,581 | 23,527,581 | |||||||||
Disposals |
| (12,756,672 | ) | (12,756,672 | ) | |||||||
|
|
|
|
|
|
|||||||
As at December 31, 2019 |
3,110,452 | 43,731,444 | 46,841,896 | |||||||||
|
|
|
|
|
|
|||||||
Amortization and impairment |
||||||||||||
As at December 30, 2016 |
| | | |||||||||
Amortization charge |
| 398,290 | 398,290 | |||||||||
|
|
|
|
|
|
|||||||
As as December 31, 2017 |
| 398,290 | 398,290 | |||||||||
|
|
|
|
|
|
|||||||
Charge for the year |
| 1,083,875 | 1,083,875 | |||||||||
|
|
|
|
|
|
|||||||
As at December 31, 2018 |
| 1,482,165 | 1,482,165 | |||||||||
|
|
|
|
|
|
|||||||
Charge for the year |
| 1,689,151 | 1,689,151 | |||||||||
Impairment |
298,625 | 6,608,387 | 6,907,012 | |||||||||
Disposals |
| (182,580 | ) | (182,580 | ) | |||||||
|
|
|
|
|
|
|||||||
As at December 31, 2019 |
298,625 | 9,597,123 | 9,895,748 | |||||||||
|
|
|
|
|
|
|||||||
Net book value |
||||||||||||
At December 30, 2016 |
| | | |||||||||
|
|
|
|
|
|
|||||||
At January 1, 2018 |
| 9,448,623 | 9,448,623 | |||||||||
|
|
|
|
|
|
|||||||
At December 31, 2018 |
| 17,984,743 | 17,984,743 | |||||||||
|
|
|
|
|
|
|||||||
At December 31, 2019 |
2,811,827 | 34,134,321 | 36,946,148 | |||||||||
|
|
|
|
|
|
All intangible assets are attributable to research and development activities carried out in the United Kingdom.
On May 14, 2019, the group entered into a new agreement with Ares Trading that replaced the existing arrangement (see note 5). The intellectual property rights in respect of FS231 returned to the group upon execution of the new agreement. As part of a portfolio review, the development of this molecule was deprioritized by management and the remaining value was impaired in full. This generated a charge of
F-89
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
£1,800,684 to the consolidated statement of comprehensive (loss)/income, and the resulting carrying value as at December 31, 2019 was £nil (2018: £1,831,897, 2017: £1,921,077).
In addition, as part of the new agreement with Ares, the group granted an exclusive license whereby Ares gained the exclusive right to develop, commercialize and manufacture another early discovery stage molecule, FS122. All further improvements are owned by Ares, and they are responsible for all further regulatory interactions. It was therefore deemed that the group no longer controls the asset and it has been derecognized. The carrying value immediately prior to the disposal was £12,574,092 and this has been recognized within costs related to collaborative agreements in the consolidated statement of comprehensive (loss)/income.
On September 9, 2019, it was decided by management that the group would focus on novel targets and so all work on molecule FS131 ceased from this date. A charge of £1,456,961 was recorded in the consolidated statement of comprehensive (loss)/income and the carrying value as at December 31, 2019 was £nil (2018: £1,615,659, 2017: £1,845,101).
On February 13, 2015, Beta entered into a collaboration and license agreement with a collaboration partner (the partner) to research and develop bispecific antibodies in immuno-oncology. Under the collaboration agreement, F-star and the partner created Fcabs against two immuno-oncology targets to generate several mAb2 drug development candidates from these Fcabs. On September 16, 2019, the partner notified the group of its intention to terminate the program (FS21). The intellectual property rights to the Fcab that was generated against this target was returned to the group, however presently there are no plans to develop this molecule further. Accordingly, an impairment charge of £3,350,742 has been recorded and the carrying value in respect of this molecule as at December 31, 2019 was £nil.
Goodwill
Goodwill arises as a result of the intellectual input from the workforce and reflects an additional amount that a buyer would pay for the business as acquired as an established business with a highly skilled workforce.
In order to perform an impairment review of goodwill, the goodwill balance relating to each subsidiary acquisition is allocated to CGUs that correspond to the intangible assets acquired (see note 27). Goodwill is allocated on a pro-rata basis, using the fair value on acquisition of the intangible assets acquired, as follows:
CGU |
Carrying
GBP |
Allocation
GBP |
||||||
FS122 |
10,787,290 | 908,783 | ||||||
FS422 |
5,035,085 | 424,184 | ||||||
FS118 |
7,705,206 | 649,130 | ||||||
FS21 |
3,544,694 | 298,625 | ||||||
FS120 |
4,829,105 | 406,831 | ||||||
FS222 |
3,928,892 | 330,992 | ||||||
Partnered Neuroscience assets |
1,090,935 | 91,907 | ||||||
|
|
|
|
|||||
36,921,207 | 3,110,452 | |||||||
|
|
|
|
Management performed an assessment of impairment of goodwill upon the impairment of certain intellectual property rights identified above and deemed an impairment charge of £298,625 was required in respect of the goodwill attributed to the FS21 program.
All impairment charges have been recognized within research and development expenses in the consolidated statement of comprehensive (loss)/income. At December 31, 2019, no intangible assets were pledged as security (2018 and 2017: £nil).
F-90
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
14. Property, plant and equipment
Leasehold
improvements £ |
Laboratory
£ |
Office
£ |
Total £ |
|||||||||||||
Cost |
||||||||||||||||
As at December 31, 2018 and December 31, 2017 |
| | | | ||||||||||||
Acquisitions (see note 27) |
10,740 | 1,315,604 | 165,785 | 1,492,129 | ||||||||||||
Disposals |
| | (17,155 | ) | (17,155 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
As at December 31, 2019 |
10,740 | 1,315,604 | 148,630 | 1,474,974 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Accumulated depreciation |
||||||||||||||||
As at December 31, 2018 and December 31, 2017 |
| | | | ||||||||||||
Charge for the year |
4,091 | 337,126 | 52,219 | 393,436 | ||||||||||||
Disposals |
| | (5,243 | ) | (5,243 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
As at December 31, 2019 |
4,091 | 337,126 | 46,976 | 388,193 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net book value |
||||||||||||||||
As at December 31, 2018 and December 31 2017 |
| | | | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
At December 31, 2019 |
6,649 | 978,478 | 101,654 | 1,086,781 | ||||||||||||
|
|
|
|
|
|
|
|
As at December 31, 2019, no property, plant or equipment was pledged as security (2018 and 2017: £nil). All property, plant and equipment is located in the United Kingdom.
15. Right-of-use assets
This note provides information for leases where the group is a lessee. The group does not have any material leases for which it acts as a lessor. Income derived from such leases has been disclosed, since they were from a related party (see note 26.3). All right-of-use assets and finance lease liabilities are generated from the leasing of office buildings.
a. Amounts recognized in the consolidated statement of financial position
December 31, 2019 Total £ |
||||
Right-of-use assets buildings |
||||
Cost |
||||
As at January 1, 2019 |
| |||
Acquisitions (see note 26) |
740,262 | |||
|
|
|||
As at December 31, 2019 |
740,262 | |||
|
|
|||
Accumulated depreciation |
||||
As at January 1, 2019 |
| |||
Depreciation charge for the year |
277,742 | |||
|
|
|||
As at December 31, 2019 |
277,742 | |||
|
|
|||
Net book value |
||||
As at January 1, 2019 & December 31, 2018 |
| |||
|
|
|||
At December 31, 2019 |
462,520 | |||
|
|
F-91
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
Lease liabilities |
December 31, 2019 Total £ |
|||
Current |
465,060 | |||
Non-current |
39,745 | |||
|
|
|||
As at December 31, 2019 |
504,805 | |||
|
|
b. Amounts recognized in the consolidated statement of comprehensive (loss)/income
The consolidated statement of comprehensive (loss)/income includes the following amounts relating to leases:
2019
Depreciation
£ |
2019 Interest cost £ |
2019 Total £ |
||||||||||
Right-of-use assets buildings |
277,742 | | 277,742 | |||||||||
Lease liability buildings |
| 22,394 | 22,394 | |||||||||
|
|
|
|
|
|
|||||||
277,742 | 22,394 | 300,136 | ||||||||||
|
|
|
|
|
|
Depreciation charge on right-of-use assets is included within administrative expenses and interest expense in relation to right-of-use assets is included within finance costs in the consolidated statement of comprehensive (loss)/income.
c. Maturity analysis contractual undiscounted cash flows
Buildings
£ |
||||
Less than one year |
478,923 | |||
One to two years |
39,910 | |||
|
|
|||
Total undiscounted lease liability as at December 31, 2019 |
518,833 | |||
|
|
|||
Impact of discounting |
(14,028 | ) | ||
|
|
|||
Carrying amount of liability |
504,805 | |||
|
|
d. Amounts recognized in the consolidated statement of cash flows
Year ended
December 31,
Total £ |
||||
Lease interest paid |
22,394 | |||
Principal elements of lease payments |
296,094 | |||
|
|
|||
318,488 | ||||
|
|
F-92
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
16. Financial assets at fair value through profit or loss
The Company has not elected to recognize fair value gains and losses through other comprehensive income for the following equity investments:
Total £ |
||||
Balance January 1, 2019 |
| |||
Unlisted participation rights acquired (see note 27) |
42,743 | |||
Foreign currency translation |
(81 | ) | ||
|
|
|||
Balance December 31, 2019 |
42,662 | |||
|
|
FVPL financial assets are denominated in euros. These assets are comprised of investments in two start-up companies in the medical research field S-TARget Therapeutics GmbH and OncoQR ML GmbH. As the products being developed by the entities are at an early stage of development, the research results are not predictable.
S-TARget Therapeutics GmbH concluded a license deal with a pharma company in 2014 for the development of therapeutic allergy vaccines. S-TARget sublicensed part of its Intellectual Property to OncoQR ML GmbH in 2017 and management are actively seeking partnering or sub-licensing deals.
Amounts recognized in profit and loss
During the period ended December 31, 2019, a loss of £nil (2018 and 2017: £nil) was recognized in the consolidated statements of comprehensive income within other expenses.
17. Cash and cash equivalents
December 31,
£ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
Cash at bank and in hand |
3,736,229 | 6,458,139 | 3,780,060 | |||||||||
|
|
|
|
|
|
|||||||
Balances per statement of cash flows |
3,736,229 | 6,458,139 | 3,780,060 | |||||||||
|
|
|
|
|
|
Cash and cash equivalents are held at amortized cost with fair value approximating to carrying value.
Reconciliation of movement in liabilities from financing activities
Note |
Lease
£ |
Borrowings £ |
Total £ |
|||||||||||||
At December 31, 2018 and December 31, 2017 |
| | | |||||||||||||
Cash flows |
(318,488 | ) | 10,051,963 | 9,733,475 | ||||||||||||
Non-cash changes |
||||||||||||||||
Acquired with subsidiaries |
800,899 | | 800,899 | |||||||||||||
Interest charged |
22,394 | 154,491 | 176,885 | |||||||||||||
Fair value adjustment on borrowings |
22 | | 1,106,313 | 1,106,313 | ||||||||||||
Foreign exchange differences |
| 51,687 | 51,687 | |||||||||||||
|
|
|
|
|
|
|||||||||||
At December 31, 2019 |
504,805 | 11,364,454 | 11,869,259 | |||||||||||||
|
|
|
|
|
|
F-93
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
18. Trade and other receivables
December 31,
£ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
Trade receivables from contracts with customers |
4,588 | | | |||||||||
Prepayments and accrued income |
1,875,313 | 259,112 | 672,254 | |||||||||
Social security and other taxes |
641,671 | | | |||||||||
Other receivables |
191,572 | 87,130 | 63,281 | |||||||||
|
|
|
|
|
|
|||||||
2,713,144 | 346,242 | 735,535 | ||||||||||
|
|
|
|
|
|
Trade receivables are amounts due from customers for services performed in the ordinary course of business. They are generally due for settlement within 30 days and therefore all classified as current. Trade receivables are recognized initially at the amount of consideration that is unconditional. The group holds trade receivables with the objective of collecting the contractual cash flows, and so it measures them subsequently at amortized cost using the effective interest method. The group does not hold any collateral as security.
The carrying value of all financial assets included within Trade and other receivables is a reasonable approximation of fair value.
19. Issued share capital
The parent Companys articles of association do not specify the authorized share capital of the entity. Issued capital comprises:
F-94
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
All ordinary and preferred shares have attached to them full voting, dividend and capital distribution (including on winding up) rights. They do not confer any rights to redemption.
20. Capital management
The groups objectives when managing capital are to safeguard the groups ability to continue as a going concern. As the business of the group requires long-term financing of its R&D the future benefits of which are uncertain, the groups ability to raise long-term funding is a key factor, which determines the success of the group.
Capital is raised through the increase of registered capital (either from existing shareholders or new investors), through shareholders equity contributions and through the issuance of convertible notes (see note 21).
Registered capital is fully paid in; shares in the registered capital have a nominal value of £0.01.
A description of the nature and purpose of each reserve is provided in note 2.13.
The equity structure in the group consolidated financial statements reflects the equity structure of FTL, the legal parent, which includes the equity instruments issued under the share-for share exchange to effect the acquisition of Delta. As Delta was designated the accounting acquirer in accordance with IFRS 3 Business Combinations, a reverse acquisition reserve was created, the value of which being the value of equity instruments issued for the acquisition of Delta.
December 31,
£ |
Restated*
December 31,
£ |
Restated^
December 31,
£ |
||||||||||
Share capital |
177,768 | 1 | 91 | |||||||||
Other reserves |
||||||||||||
Group restructuring reserve |
76,745,484 | | | |||||||||
Reverse acquisition reserve |
(31,483,690 | ) | 90 | | ||||||||
|
|
|
|
|
|
|||||||
45,261,794 | 90 | | ||||||||||
(Accumulated losses)/retained earnings |
(16,907,806 | ) | 15,861,034 | 3,479,260 | ||||||||
|
|
|
|
|
|
|||||||
Capital managed |
28,531,756 | 15,861,125 | 3,479,351 | |||||||||
|
|
|
|
|
|
* See note 4.9 for explanation of restatement of prior year deferred tax.
21. Loans and borrowings
December 31,
£ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
Current |
||||||||||||
Lease liability |
465,060 | | | |||||||||
Convertible notes held at FVTPL (unsecured) |
11,364,454 | | | |||||||||
|
|
|
|
|
|
|||||||
11,829,514 | | | ||||||||||
|
|
|
|
|
|
|||||||
Non-current |
||||||||||||
Lease liability |
39,745 | | | |||||||||
|
|
|
|
|
|
|||||||
39,745 | | | ||||||||||
|
|
|
|
|
|
|||||||
Total |
11,869,259 | | | |||||||||
|
|
|
|
|
|
All of the groups finance lease liabilities arise from the leasing of office buildings. See note 15 for the associated right-of-use assets.
F-95
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
F-star Therapeutics Limited issued USD denominated, 8% convertible notes on September 19, 2019 for USD $6.6 million (£4.9 million) and a second tranche of convertible notes was issued on November 27, 2019 for USD $6.6 million (£5.1 million) under the same terms.
The notes are convertible into a variable number of series A preference shares at the option of the holder. On expiry of the term, if no conversion notice has been issued prior to August 18, 2020, the notes shall be redeemable at principal plus accrued interest. Notes, together with interest outstanding, shall automatically convert into series A preference shares in the event F-star Therapeutics Limited raises at least USD $50 million or there is a change of control.
Unless the notes are convertible upon expiry of the term, the conversion rate for each note held plus accrued interest, is the lesser of: 1.25 shares based on the market price per share on the conversion date, or USD $100 million divided by the number of shares in issue plus the number of shares capable of being issued. Upon expiry of the term, the notes are converted at a rate of USD $60 million divided by the number of shares in issue plus the number of shares capable of being issued.
The convertible notes are presented in the statement of financial position as follows:
December 31,
£ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
Face value of the notes issued |
10,051,963 | | | |||||||||
Fair value adjustment through profit or loss |
1,106,313 | | | |||||||||
Interest charged |
154,491 | | | |||||||||
Foreign exchange loss |
51,687 | | | |||||||||
|
|
|
|
|
|
|||||||
Current liability |
11,364,454 | | | |||||||||
|
|
|
|
|
|
The fair value of the convertible notes was measured using level 3 inputs as described in note 3.2. The inputs used to calculate fair value are described in note 4.
The following table presents the changes in level 3 items for the periods ending December 31, 2019, 2018 and 2017.
Convertible
£ |
||||
Balance at December 31, 2018 and December 31, 2017 |
| |||
Losses recognized in statement of comprehensive (loss)/income |
1,106,313 | |||
|
|
|||
Balance at December 31, 2019 |
1,106,313 | |||
|
|
The fair value is materially different from the value of convertible notes than if they were held at amortized cost as at December 31:
2019 Fair value £ |
2019 Amortized cost £ |
2018 and 2017 Fair value £ |
2018 and 2017 Amortized cost £ |
|||||||||||||
Convertible notes |
11,364,454 | 10,258,141 | | | ||||||||||||
|
|
|
|
|
|
|
|
The difference between the carrying value of the convertible notes and the amount that the entity would be contractually required to repay at maturity of £10,838,498 to the holder of the obligation is £525,956.
F-96
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
22. |
Trade and other payables |
December 31,
£ |
December 31, 2018 £ |
December 31, 2017 £ |
||||||||||
Due within one year |
||||||||||||
Trade payables and other payables |
3,854,667 | 469,953 | 315,041 | |||||||||
Amounts owed to related parties |
| 616,945 | 784,378 | |||||||||
Accrued expenses |
6,558,635 | 468,484 | 242,460 | |||||||||
Other creditors |
208,655 | | | |||||||||
|
|
|
|
|
|
|||||||
10,621,957 | 1,555,382 | 1,341,879 | ||||||||||
|
|
|
|
|
|
Trade payables principally comprise amounts outstanding for trade purchases and ongoing costs. Accruals contain payables due to employees for outstanding bonus and other accruals. No interest is charged on trade payables and amounts owed to related parties and balances are normally cleared within 30 days.
The carrying amounts of trade and other payables are considered to be the same as their fair values, due to their short-term nature.
23. |
Share-based payments |
Corporate reorganization, business combination and asset acquisition
The transactions enacted to bring the F-star Group Entities under the common ownership of FTL were completed on May 7, 2019. As part of the reorganisation, the entire issued share capital of Alpha, Beta, Delta and GmbH was transferred to FTL in consideration of the issue of new shares in FTL to the shareholders of Alpha, Beta, Delta and GmbH. The number and class of shares in each F-star Group Entity which were transferred to FTL and the number and class of the shares in FTL received by the shareholders in the F-star Group Entities is set out in the table below. No other assets, including cash, were transferred as consideration for the corporate reorganization. The transaction price was measured as the value of shares issued (see note 26 for more detail). The exchange ratio for each entity was as follows:
GmbH |
Alpha |
Beta |
Delta |
|||||
Exchange ratio for shares in FTL |
For each share held in GmbH, the shareholders received 3.34526 shares of series A preferred shares, seed preferred shares, or ordinary shares in FTL depending on the liquidation rights contractually attached to the original shares held in GmbH. Holders of options to purchase ordinary shares of GmbH also swapped their |
For each series A preferred share and/or ordinary share held in Alpha, the shareholders received 0.06473 ordinary shares in FTL Holders of options to purchase ordinary shares of Alpha also swapped their existing options for new options to purchase ordinary shares of FTL at the same exchange ratio of 0.06473. |
For each series A preferred share and/or ordinary share held in Beta, the shareholders received 0.68939 ordinary shares in FTL Holders of options to purchase ordinary shares of Beta also swapped their existing options for new options to purchase ordinary shares of FTL at the same exchange ratio of 0.68939. |
For each ordinary share held in Delta, the shareholders received one ordinary share in FTL (Note: There are no holders of options to purchase ordinary shares in Delta) |
F-97
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
GmbH |
Alpha |
Beta |
Delta |
|||||
existing options for new options to purchase ordinary shares of FTL at the same exchange ratio of 3.34526. | ||||||||
Total number and class of shares issued by FTL to shareholders | 1,441,418 series A preferred shares, 103,611 seed preferred shares and 125,715 ordinary shares | 570,387 ordinary shares | 6,446,843 ordinary shares | 9,053,538 ordinary shares |
As a result of the exchange of shares above, a total of 17,741,512 shares were issued by FTL, comprising of 1,441,418 series A preferred shares, 103,611 seed preferred shares, and 16,196,483 ordinary shares. The series A preferred shares and seed preferred shares each carry a fixed preferential return that ranks in priority to the ordinary shares on a winding up or return of capital but otherwise rank equally alongside the ordinary shares in terms of voting and dividend rights. None of the series A preferred shares, seed preferred shares or ordinary shares in FTL carry any rights of redemption.
The exchange ratio for each entity was determined based on an assessment of the relative value of each company determined using an internally generated risk-adjusted discounted cash flow model. The sole purpose of the internal model was to identify the relative size of each entity and determine an appropriate exchange ratio to be applied to the share exchange. The model was not intended to represent the fair value of each entity in terms of transaction price. Lastly, the basis of the computation of the cash flow model and thus, the underlying relative split, was contractually agreed through negotiation with the shareholders of each F-star Group Entity, resulting in an exchange ratio that each F-star Group Entity deemed an acceptable exchange for their prior ownership.
New and modified share options issued in the year
On June 14, 2019, as part of the group restructuring, the parent companys board of directors and shareholders approved the 2019 Equity Incentive Plan (or the 2019 Plan). The initial maximum number of ordinary shares that could be issued under the 2019 Plan was 2,327,736. This number consisted of 1,922,241 new ordinary shares and 405,495 new ordinary shares as replacements for grants under the previous F-star Group Entities share options schemes (F-star Alpha Limited Share Option Scheme, the F-star Beta Share Option Scheme and the GmbH F-star EMI Share Option Scheme). In addition, a legacy ESOP plan, which granted certain ex-employees exit participation rights was transferred to FTL from GmbH. The ESOP entitles the beneficiaries to receive a proportion of the exit proceeds realized by shareholders and the transfer of the participation rights occurred at the same exchange ratio as used for the exchange of GmbH shares for shares issued by FTL.
The number of ordinary shares reserved for issuance under the 2019 Plan will automatically increase on January 1, each year for a period of not more than ten years, commencing on January 1, 2020 and ending on (and including) January 1, 2029, by an amount equal to the lesser of i) 4% of the total number of ordinary shares outstanding on December 31 of the preceding calendar year or ii) the number of ordinary shares as the board of directors may designate prior to the applicable January 1, date.
Options granted under the 2019 Plan vest over a four-year service period with 28% of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three years. Options generally expire 10 years from the date of the grant. For certain senior members of management and directors, the board of directors has approved an alternative vesting schedule.
F-98
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
A reconciliation of the movement in share options during the year ended December 31, 2019 is shown below:
2019 Number |
2019
Weighted
|
|||||||
Outstanding at January 1 |
| | ||||||
Granted in the period (including replacement of legacy options issued as FTL options) |
2,398,986 | £ | 0.64 | |||||
Exercised in the period |
(35,148 | ) | £ | 0.00 | ||||
Forfeited in the period |
(59,132 | ) | £ | 0.01 | ||||
|
|
|
|
|||||
Outstanding at December 31 |
2,304,706 | £ | 0.67 | |||||
|
|
|
|
|||||
Exercisable at December 31 |
559,813 | £ | 0.47 | |||||
|
|
|
|
The weighted average share price at the time of exercise was £1.71 (equivalent to USD $2.18) each. There were no transaction costs incurred by the group in connection with the exercise.
Share options outstanding at the end of the year have the following expiry dates and exercise prices:
Grant date | Expiry date |
Remaining
(months) |
Exercise
price |
2019 Number |
||||||
June 14, 2019 |
June 14, 2029 | 114 | £0.00 - £0.05 | 370,347 | ||||||
June 14, 2019 |
June 14, 2029 | 114 | $1.87 | 939,954 | ||||||
June 14, 2019 |
June 14, 2029 | 114 | £0.01 | 923,455 | ||||||
July 1, 2019 |
July 1, 2029 | 114 | £0.01 | 950 | ||||||
December 18, 2019 |
December 18, 2029 | 120 | $1.61 | 35,000 | ||||||
December 18, 2019 |
December 18, 2029 | 120 | £0.01 | 35,000 | ||||||
|
|
|||||||||
2,304,706 | ||||||||||
|
|
As of December 18, 2019, the Board and the shareholders authorized an additional 150,000 share options to be added to the share option pool. The total number of share options available to issue at December 31, 2019 was 2,477,736.
Share option valuation (equity-settled)
The assumptions used in the Black-Scholes option pricing model to determine the fair value of the share options granted to employees and directors during the year ended December 31, 2019 were as follows:
June 14, 2019 (US Grants) |
June 14, 2019 &
(UK Grants) |
December 18,
(US Grants) |
December 18,
(UK Grants) |
|||||||||||||
Share price at grant date |
£ | 2.45 | £ | 2.45 | £ | 1.70 | £ | 1.70 | ||||||||
Exercise price |
£ | 1.47 | £ | 0.01 | £ | 1.22 | £ | 0.01 | ||||||||
Term (years) |
5.054 | 5.054 | 5.054 | 5.054 | ||||||||||||
Expected volatility |
70.03 | % | 70.03 | % | 70.31 | % | 70.31 | % | ||||||||
Expected dividends expressed as a dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % | ||||||||
Risk-free rate |
1.85 | % | 1.85 | % | 1.74 | % | 1.74 | % | ||||||||
Fair value per option |
£ | 1.7057 | £ | 2.4590 | £ | 1.1611 | £ | 1.7577 |
The expected volatility is based on the estimate of the average of the volatility of peer companies in the biotechnology sector. The term is the average expected period from grant to exercise. The determination of the
F-99
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
appropriate risk-free rate is based upon the Federal Reserve market yield on U.S. Treasury Securities at 5-year constant maturity for US grants and the 5-year Gilt bond yield for UK grants, on Investment basis.
Share-based compensation charge
The group recorded share-based compensation expense as follows:
December 31, 2019 £ |
||||
Cancelled options |
24,307 | |||
Modified options |
41,389 | |||
New options with alternative vesting schedule |
900,714 | |||
New options with standard vesting |
1,146,687 | |||
|
|
|||
2,113,097 | ||||
|
|
As of December 31, 2019, there was £2,020,728 of unrecognized compensation cost related to outstanding but unvested share options, which is expected to be recognized over a weighted-average period of 2.89 years.
The total share-based compensation expense is recorded within the consolidated financial statements of the group as follows:
December 31,
2019
|
||||
Research and development |
437,139 | |||
General and administration |
1,675,958 | |||
|
|
|||
Total recognized in consolidated statement of comprehensive (loss)/income |
2,113,097 | |||
|
|
Share-based compensation charge (modified options equity-settled)
In accordance with IFRS 3, FTL has allocated equity instruments between the cost of the business combination and post-combination services for replacement awards granted to the employees with legacy options in Alpha. Beta and GmbH. The share-based compensation expense attributable to the extent that the legacy options had vested at the acquisition date of £1,285,892 was included in the consideration and allocated to the acquired goodwill assets of Beta and GmbH (see note 26).
The share-based compensation expense attributable to the unvested portion of £41,389 is recognised in the consolidated statement of comprehensive (loss)/income in the period between the acquisition date to December 31, 2019. The corresponding credited amounts for both pre- and post-combination share-based payment compensation charges have been recorded in retained earnings. The weighted average option price was £2.4590 as at the replacement date June 14, 2019.
Modified share options
The table reflects the conversion of replacement legacy share options in FTL at June 14, 2019:
Number of
options |
||||
Replacement legacy options issued as FTL options |
405,495 | |||
Vested options as at June 14, 2019 |
(371,369 | ) | ||
|
|
|||
Post-corporate reorganization legacy options issued as FTL options |
34,126 | |||
|
|
F-100
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
As at June 14, 2019, the unvested options comprised 32,908 options related to the legacy GmbH F-star EMI Share Option Scheme, and 1,218 options related to the F-star Beta Share Option Scheme. The legacy options were fully vested for the F-star Alpha Share Option Scheme. In the period between June 14, 2019 and December 31, 2019, the options for the F-star Beta Share Option Scheme were fully vested.
As of December 31, 2019, there was £42,526 of unrecognized compensation cost related to 17,294 share options which were both outstanding and unvested relating to the legacy GmbH F-star EMI Share Option Scheme, which amounts are expected to be recognized over a weighted-average period of 2.83 years.
24. |
Commitments |
As at December 31, 2019 the group has contracted commitments with a contract manufacturing organization (CMO) as of December 31, 2019 amounting to £734,734 (2018 and 2017: £nil) for activities that are ongoing or are scheduled to start between 3 and 9 months of the date of the statement of financial position. Under the terms of the agreement with the CMO, the group is committed to pay for some activities if they are cancelled up to 3, 6 or 9 months prior to the star date of the activity.
The Group operates a bonus plan for qualifying employees of the Group. The plan is settled in cash and is subject to certain financial targets. At December 31, 2019 management do not consider it probable that the financial targets will be met in the foreseeable future. The maximum liability payable under the bonus plan is £1,345,000.
The company has no significant capital expenditure contracted for, but not recognized as a liability at December 31, 2019 (2018 and 2017: £nil).
25. Related parties
25.1 |
Corporate reorganization, business combination and asset acquisition |
The transactions that resulted in the corporate reorganization, business combination and asset acquisition in the current year are deemed to be related party transactions by virtue of common directorships between the entities (see note 26).
25.2 |
Parent entity |
Until May 7, 2019, there was no ultimate controlling party of Delta or FTL. The consolidated group was formed on May 7, 2019 (see note 26). Since May 7, 2019, FTL has been the immediate and ultimate controlling party. The parent undertaking of the smallest and largest group to consolidate these financial statements is FTL.
Related party transactions and balances in the period to May 6, 2019 and the years ended December 31, 2018 and 2017 relate to those applicable to the accounting acquirer and legal subsidiary, Delta, only.
The parent Company has a guarantee in place such that each UK subsidiary as listed below is exempt under section 479A of the Companies Act 2006 from the requirements related to the audit of individual accounts of the following subsidiaries:
Country of
incorporation |
Nature of business |
Proportion of ordinary
(%) |
Direct/
indirect |
|||||||
F-star Alpha Limited |
UK | Research & development | 100 | % | Direct | |||||
F-star Beta Limited |
UK | Research & development | 100 | % | Direct | |||||
F-star Delta Limited |
UK | Research & development | 100 | % | Direct | |||||
F-star Biotechnology Limited |
UK | Research & development | 100 | % | Indirect | |||||
F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H |
Austria | Intermediate holding company | 100 | % | Direct | |||||
F-star Therapeutics LLC |
US | Research & development | 100 | % | Indirect |
F-101
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
25.3 |
Convertible notes |
During the period ended December 31, 2019 the legal parent entity of the group issued convertible debt notes to certain of its shareholders (see note 21).
25.4 |
Key management personnel (including directors) |
During the year to December 31, 2019, the group had purchases totaling £120,000 (2018: £nil) from Avacta Life Sciences Limited, a company in which director E. Forster also holds a directorship. As at December 31, 2019, the amounts outstanding and included in trade and other payables was £60,000 (2018: £nil).
On February 28, 2019, the group entered into a sub-lease rental arrangement with US-based company, Triplet Therapeutics, Inc. N. Bermingham who is a non-executive director of the group serves as the Chief Executive Officer of Triplet Therapeutics, Inc. The lease was terminated with effect from December 31, 2019. Concurrently, the group no longer acts as a lessor from this date and there are no material ongoing commitments with respect to this lease. Income from Triplet Therapeutics totaled £111,289 (2018: £nil) in respect of office rental and related office costs. As at December 31, 2019, amounts receivable included in trade and other receivables was £4,588 (2018 and 2017: £nil).
All other transactions with key management (all remuneration-related) are stated in note 10.
25.5 Related party transactions prior to corporate reorganization, business combination and asset acquisition
A summary of related party transactions for the year ended December 31, 2019 and December 31, 2018 where exemption from reporting transactions and balances between group undertakings is unavailable under IAS 24 Related Party Disclosures, are disclosed below.
Some of the directors of Delta are also directors of Beta as well as members of the supervisory board of GmbH, which has a wholly owned subsidiary, F-star Biotechnology Limited.
Delta, Beta and F-star Biotechnology Limited entered into an intellectual property license agreement and a support services agreement whereby Delta sub-licensed certain intellectual property rights from F-star Biotechnology Limited, via a sublicense to Beta. F-star Biotechnology Limited agreed to provide support services to the Company via Beta. Transactions in the period to December 31, 2019 with Beta and F-star Biotechnology Limited were as follows:
R&D
2019 £ |
Other
£ |
R&D
2018 £ |
Other
£ |
|||||||||||||
Expenses |
||||||||||||||||
Beta |
1,863,660 | 483,653 | 8,013,172 | | ||||||||||||
F-star Biotechnology Limited |
206,221 | | 488,726 | 113,163 | ||||||||||||
GmbH |
| 11,536 | | 82,464 | ||||||||||||
2019 £ |
2018 £ |
|||||||||||||||
Payable as at December 31 |
||||||||||||||||
Beta |
| | | (412,156 | ) | |||||||||||
F-star Biotechnology Limited |
| | | (187,892 | ) | |||||||||||
GmbH |
| | | (16,897 | ) | |||||||||||
Intangible asset acquisitions |
||||||||||||||||
Acquired from Beta |
| | | 9,619,995 |
F-102
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
R&D
2017 £ |
Other
£ |
|||||||
Expenses |
||||||||
Beta |
4,224,732 | | ||||||
F-star Biotechnology Limited |
1,039,396 | |
2017 £ |
||||
Payable as at December 31 |
||||
Beta |
(730,489 | ) | ||
F-star Biotechnology Limited |
(34,831 | ) | ||
Intangible asset acquisitions |
||||
Acquired from Beta |
9,846,913 |
R&D recharges relate to research paid for by Delta and carried out by F-star Biotechnology Limited, under the terms of its agreement with Beta. These research services are based on time incurred and are charged on an FTE basis.
In addition, certain non-employment related costs associated with the research activities of Delta were incurred by F-star Biotechnology Limited and recharged back to Delta. GmbH invoiced Delta for its portion of board costs.
26. Corporate reorganization, business combination and asset acquisition
On May 7, 2019, the Company (FTL) completed a corporate reorganization pursuant to which FTL became the direct holding company of each of Alpha, Beta, Delta, and GmbH and the indirect holding company of each of F-star Biotechnology Limited (Biotech), and F-star Therapeutics LLC (LLC) collectively, the F-star Group Entities. Prior to the transactions described below, all F-star Group entities were deemed to be related parties due to common directorships.
Exchange of Delta Shares for FTL Shares (corporate reorganization)
All shareholders of Delta exchanged each of the shares held by them in Delta for the same class and number of newly issued shares of FTL and, as a result, Delta became a wholly owned subsidiary of FTL. The number of shares issued was 9,053,538 at a ratio of 1:1. This was accounted for as Delta obtaining a controlling interest in FTL using reverse acquisition accounting principles.
FTL, the legal acquirer of Delta and the other F-star Group Entities (see below), is an entity with no historical operations and was created solely for the purpose of effecting the corporate reorganization. Accordingly, for accounting purposes, it was not deemed substantive nor the accounting acquirer of the F-star Group Entities. The effect of using reverse acquisition accounting is that the historical (prior to the date of acquisition) financial statements of FTL reflect the operations and historical financial position and financial performance of legal subsidiary Delta (the accounting acquirer).
Exchange of GmbH, Beta and Alpha Shares for FTL Shares (business combination and asset acquisition)
Effective as of the date of and subsequent to the Delta share exchange, all shareholders of each of Alpha, Beta and GmbH exchanged each of the shares held in Alpha, Beta and GmbH for newly issued shares in FTL. As a result, Alpha, Beta and GmbH became wholly owned subsidiaries of FTL. Holders of options to purchase shares of Alpha, Beta and GmbH swapped their existing options for new options to purchase shares of FTL.
GmbH and Beta were deemed to meet the definition of a business in accordance with IFRS 3 Business Combinations. The acquisition of GmbH and Beta was accounted for a business combination, and the acquisition
F-103
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
of a controlling interest in Alpha was accounted for as an asset acquisition. No other assets, including cash, were transferred or liabilities assumed as consideration for the corporate reorganization. The transaction price was measured as the fair value of equity issued in accordance with IFRS 3 Business Combinations.
Had the corporate reorganization, business combination and asset acquisition occurred on January 1, 2019, pro-forma revenue for the consolidated group for the year ended December 31, 2019 would have been £22.2 million and net loss for the year ended December 31, 2019 would have been £43.1 million. These amounts have been calculated using the subsidiaries results and adjusting for the additional amortization that would have been charged assuming the fair value adjustments to intangible assets had been applied from January 1, 2019, together with the consequential tax effects.
All associated transaction costs were expensed and are included in administrative expenses. The transaction costs included the attributable costs of the issuance of the shares by FTL which are considered to be immaterial by management. There were no acquisitions in the year ended December 31, 2018 or 2017.
Settlement of pre-existing relationships between the F-star entities resulted in the addition of £23,527,581 intangible assets to Delta, which was accounted for separately from the business combination (see note 13).
Details of the purchase consideration, net assets acquired and goodwill are as follows:
26.1 FTL
FTLs net asset position was as follows, immediately prior to the corporate reorganization:
£ | ||||
Cash |
| |||
Other current assets |
| |||
Intangible assets |
| |||
Current liabilities |
| |||
|
|
|||
| ||||
|
|
The acquisition of FTL by Delta contributed revenue of £nil and a loss of £3,665,409 to the groups results in 2019.
26.2 Beta
£ | ||||
Purchase consideration |
||||
Ordinary shares issued |
4,219,308 | |||
|
|
|||
Total purchase consideration |
4,219,308 | |||
|
|
The fair value of the 6,446,843 ordinary shares that were issued as consideration paid for the acquisition of Beta was based on the fair value of the total issued equity of Beta on the acquisition date. This was measured using level 3 inputs as described in note 3.2.
The assets and liabilities recognized as a result of the acquisition of Beta are as follows:
£ | ||||
Cash |
915,436 | |||
Other current assets |
4,157,960 | |||
Intangible assets |
12,302,691 | |||
Current liabilities |
(14,714,909 | ) | ||
Goodwill |
1,558,130 | |||
|
|
|||
4,219,308 | ||||
|
|
F-104
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
The goodwill is attributable to the contracted access to an organized workforce and will not be deductible for tax purposes.
The acquisition of Beta by Delta contributed revenue of £nil and a loss of £9,635,435 to the groups results in 2019.
The intangible assets acquired with Beta are summarized in the table below. The methodologies used to determine the fair value of the intangibles acquired are described in note 3.2.
Asset |
FV £ |
Description | ||||
FS21 |
3,544,694 |
Contracted future cash flows relating to a drug candidate that has been licensed to a collaboration partner |
||||
FS120 |
4,829,105 |
Internally developed drug candidate, for which Beta holds the IP rights |
||||
FS222 |
3,928,892 |
Internally developed drug candidate, for which Beta holds the IP rights |
||||
|
|
|||||
12,302,691 | ||||||
|
|
26.3 |
GmbH Group |
£ | ||||
Purchase consideration |
||||
Preferred and ordinary shares issued |
7,155,411 | |||
|
|
|||
Total purchase consideration |
7,155,411 | |||
|
|
The fair value of the 1,441,418 series A preferred shares, 103,611 seed preferred shares and 125,715 ordinary shares that were issued as consideration paid for the acquisition of GmbH Group was based on the fair value of the total issued equity of GmbH Group on the acquisition date. These values were measured using level 3 inputs as described in note 3.2.
The assets and liabilities recognized as a result of the acquisition of GmbH Group are as follows:
Total £ |
||||
Cash |
722,631 | |||
Other current assets |
13,830,265 | |||
Property and equipment (net) |
1,492,129 | |||
Right of use assets (net) |
740,262 | |||
Intangible assets |
1,090,935 | |||
Unlisted participation rights |
42,743 | |||
Current liabilities |
(11,962,256 | ) | ||
Other non-current liabilities |
(353,620 | ) | ||
Goodwill |
1,552,322 | |||
|
|
|||
7,155,411 | ||||
|
|
The acquisition of GmbH Group contributed revenue of £1,882,102 and a loss of £11,076,819 to the groups results in 2019.
The goodwill is attributable to the workforce and will not be deductible for tax purposes.
The intangible assets acquired with GmbH are summarized in the table below. The methodologies used to determine the fair value of the intangibles acquired are described in note 3.2.
Asset |
FV £ |
Description | ||||
Neuroscience assets |
1,090,935 | Contracted future cash flows relating to two drug candidates that have been licensed to a collaboration partner | ||||
|
|
|||||
1,090,935 | ||||||
|
|
F-105
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
26.4 Alpha
The fair value of the 570,387 ordinary shares issued to acquire Alpha was £10,259,414. The net assets acquired were comprised of cash, other current assets, and non-current liabilities. There were no tangible or intangible assets acquired.
27. |
Subsequent events |
On March 11, 2020 the World Health Organization declared the novel strain of coronavirus (COVID-19) a global pandemic and recommended containment and mitigation measures worldwide. It is likely that the outbreak will impact the groups operations, but at the date of the signing of the financial statements management cannot reasonably estimate the length or severity of the pandemic or the extent to which the disruption may materially impact the business. Management took the decision in April 2020 to furlough a significant proportion of the R&D workforce and so project timelines may be delayed, which could impact the significant accounting estimates utilized in:
|
inputs into the cost-to-cost method for revenue recognition; and |
|
assessment of impairment of the carrying value of group intangible assets |
At the date of issuance there were no significant impacts identified by management, but management cannot reasonably estimate the length or severity of the pandemic or the extent to which the disruption may materially impact the business in future. At this point it is not clear whether any project delays can be mitigated in the second half of 2020. Any adverse impact on operations, business or financial outlook could be material and management continues to closely monitor the situation.
As noted above the group furloughed a proportion of the R&D workforce and as a result claimed UK government grant income of £371,312 under the Coronavirus Job Retention Scheme (CJRS). The grant income has been accounted for in accordance with IAS 20 Accounting for Government Grants and Disclosure of Government Assistance.
On July 29, 2020, F-star entered into a share exchange agreement with Spring Bank Pharmaceuticals Inc (Spring Bank), a NASDAQ- listed, clinical-stage biopharmaceutical company. Pursuant to the share exchange agreement, Spring Bank will acquire the entire issued share capital of F-star in exchange for newly issued shares of Spring Bank common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the required approval of Spring Bank stockholders.
Spring Bank shareholders will have the opportunity to obtain potential future value in the form of two Contingent Value Rights (CVR) associated with Spring Banks SB 11285 IV clinical program and a STING antagonist research and development program. Subject to the terms of the first CVR agreement for the STING agonist clinical program, if one or more strategic transactions are consummated for SB 11285 by the combined company during a period that is the longer of one and a half years following the closing of the combination or one year after the final database lock of the current SB 11285 IV Phase 1a/1b trial, those equity holders of Spring Bank will receive the greater of 25% of the net proceeds from such transactions or $1.00 per share (on a pre-reverse split basis), provided that the aggregate net proceeds are at least approximately $18.0 million. Subject to the terms of the second CVR agreement, if a potential development agreement is consummated and one or more strategic transactions are consummated for the STING antagonist research platform by the combined company during the seven (7)-year period following the closing of the combination, those equity holders of Spring Bank will receive 80% of the net proceeds from such transactions. If Spring Bank enters into a development agreement for the STING antagonist research platform in advance of the closing of the proposed combination, Spring Bank may include certain proceeds from such transaction in its net cash calculation.
At the closing of the Exchange, 267,937 fully vested share options that are not exercisable at the reporting date due to an exit condition will be immediately exercised. The exercised options have a weighted average exercise price of £0.01. FTL will be subject to an immaterial payroll tax charge on the exercise of these options.
F-106
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
On July 15, 2020, a deed of amendment was enacted in respect of the May 13, 2019 License and Collaboration agreement between the group and Ares Trading S.A. The amendment had two main purposes (i) to allow Ares to exercise its option early to acquire intellectual property rights to the second molecule included in the agreement; and (ii) to grant additional options to acquire intellectual property rights for a further two molecules. As a result of this amendment all performance obligations under the May 13, 2019 agreement in respect of the second molecule were deemed to have been fully satisfied at July 15, 2020 and the group derecognized the associated intangible asset. The option fee of £6.7 million (7.5 million) was recognized at a point in time and the carrying value of the intangible asset prior to disposal was £6.2 million.
As a result of this amendment, the maximum amount payable by Ares Trading S.A on the achievement of certain development and regulatory milestones in the aggregate is increased to £348.8 million (408.5 million), and the maximum amount payable on the achievement of certain commercial milestones is increased to £215.2 million (252 million).
On July 14, 2020 the convertible notes were modified by extending the expiry date from September 19, 2020 to January 31, 2021.
28. |
(Losses)/earnings per share |
Year ended
2019 £ |
Restated*
Year ended
£ |
Restated*
Year ended
£ |
||||||||||
(Losses)/earnings per share for the year: |
||||||||||||
basic and diluted |
(2.37 | ) | 1.47 | 0.38 | ||||||||
2019 Number |
2018 Number |
2017 Number |
||||||||||
Weighted average number of ordinary shares for basic losses/earnings per share |
13,734,903 | 9,053,658 | 9,053,658 | |||||||||
Effect of dilution (share options and convertible debt) |
| | | |||||||||
|
|
|
|
|
|
|||||||
Weighted average number of ordinary shares adjusted for the effect of dilution |
13,734,903 | 9,053,658 | 9,053,658 | |||||||||
|
|
|
|
|
|
* See note 4.9 for explanation of restatement of prior year deferred tax.
The calculations of basic and diluted (losses)/earnings per share are based on the net loss attributable to ordinary equity holders of the F-star Therapeutics Limited for the year of £32,560,958 (2018: restated profit of £13,268,598, 2017: restated profit of £3,479,261). Basic (losses)/earnings per share amounts are calculated by dividing the net profit attributable to equity holders by the weighted average number of the legal parents issued ordinary shares outstanding during the year. For the purpose of the calculation, the number of shares prior to the corporate reorganization is deemed to be 9,053,658. This is the number of the Deltas ordinary shares as at January 1, 2019, adjusted by the exchange ratio of the corporate reorganization.
Diluted earnings per share is calculated by adjusting the weighted average number of ordinary shares outstanding to assume conversion of all dilutive potential ordinary shares. During the year ended December 31, 2019, the legal parent issued two categories of dilutive potential ordinary shares: convertible debt and share options. The convertible debt is assumed to have been converted into ordinary shares, and the net profit is adjusted to
F-107
F-star Therapeutics Limited
December 31, 2019
Notes to the Consolidated Financial Statements
eliminate the interest expense less the tax effect. For the share options, the number of shares that could have been acquired at fair value (as determined by business valuations) is calculated based on the monetary value of the subscription rights attached to outstanding share options. The number of shares calculated as above is compared with the number of shares that would have been issued assuming the exercise of the share options.
The group incurred a loss for the year ended December 31, 2019 and as a result, the dilutive potential ordinary shares had a non-dilutive impact on earnings per share. As such the diluted earnings per share is reported to be the same as basic earnings per share. There were no dilutive potential ordinary shares in the year ended December 31, 2018 or December 31, 2017.
F-108
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H and its subsidiaries (the Company) as of May 6, 2019, December 31, 2018 and 2017, and the related consolidated statements of comprehensive income, consolidated statements of changes in equity and consolidated statements of cash flows for the period ended May 6, 2019 and the years ended December 31, 2018 and 2017, including the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of May 6, 2019, December 31, 2018 and 2017, and the results of its operations and its cash flows for the period ended May 6, 2019 and the years ended December 31, 2018 and 2017 in conformity with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
Changes in Accounting Principles
As discussed in Note 2.4 to the consolidated financial statements, the Company changed the manner in which it accounts for leases in 2019 and the manner in which it accounts for revenues from contracts with customers in 2018.
Substantial Doubt About the Companys Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2.2 to the consolidated financial statements, the Company will require additional financing to fund its operating expenses and capital expenditure requirements which raises substantial doubt about its ability to continue as a going concern. Managements plans in regard to these matters are also described in Note 2.2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on the Companys consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
Cambridge, United Kingdom
August 28, 2020
We have served as the Companys auditor since 2018.
F-111
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
Note |
Period ended May 6, 2019 |
Year ended
2018 |
Year ended
2017 |
|||||||||||
Revenue |
5 | 9,057,540 | 21,088,390 | 15,749,415 | ||||||||||
Other income |
6 | 591,221 | 505,032 | 231,538 | ||||||||||
Raw materials and consumables used |
(1,338,846 | ) | (3,959,930 | ) | (2,958,089 | ) | ||||||||
Depreciation, amortization and loss on disposal |
(453,934 | ) | (835,458 | ) | (559,383 | ) | ||||||||
Employee expenses |
7 | (3,369,435 | ) | (7,994,504 | ) | (6,853,326 | ) | |||||||
Other expenses |
(3,087,303 | ) | (7,428,919 | ) | (5,613,168 | ) | ||||||||
|
|
|
|
|
|
|||||||||
Operating profit/(loss) |
8 | 1,399,243 | 1,374,611 | (3,013 | ) | |||||||||
Finance income |
9 | 124,549 | 163,781 | 116,215 | ||||||||||
Finance costs |
9 | (108,521 | ) | (223,377 | ) | (201,265 | ) | |||||||
|
|
|
|
|
|
|||||||||
Net finance income/ (costs) |
16,028 | (59,596 | ) | (85,050 | ) | |||||||||
|
|
|
|
|
|
|||||||||
Profit/(loss) before tax on ordinary activities |
1,415,271 | 1,315,015 | (88,063 | ) | ||||||||||
Income tax (charge)/credit |
10 | (49,384 | ) | 195,154 | 225,401 | |||||||||
|
|
|
|
|
|
|||||||||
Profit for the period |
1,365,887 | 1,510,169 | 137,338 | |||||||||||
|
|
|
|
|
|
|||||||||
Profit attributable to owners of the parent |
1,365,887 | 1,510,169 | 137,338 | |||||||||||
All profits and losses relate to continuing operations |
||||||||||||||
Other comprehensive income: |
||||||||||||||
Items that may be subsequently reclassified to profit or loss |
||||||||||||||
Currency translation differences |
(426,280 | ) | 72,676 | 44,356 | ||||||||||
|
|
|
|
|
|
|||||||||
Other comprehensive (loss)/income for the period |
(426,280 | ) | 72,676 | 44,356 | ||||||||||
|
|
|
|
|
|
|||||||||
Total comprehensive income attributable to owners of the parent |
939,607 | 1,582,845 | 181,694 | |||||||||||
|
|
|
|
|
|
|||||||||
Earnings per share for profit attributable to the shareholders of the Company: |
||||||||||||||
Basic earnings per share |
26 | 2.26 | 2.50 | 0.23 | ||||||||||
Diluted earnings per share |
26 | 2.15 | 2.50 | 0.23 |
The accompanying notes form an integral part of these consolidated financial statements.
F-112
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Note |
2019 |
2018 |
2017 |
|||||||||||||
ASSETS |
||||||||||||||||
Non-current assets |
||||||||||||||||
Intangible assets, net |
11 | 184,450 | 193,375 | 218,875 | ||||||||||||
Property, plant and equipment, net |
12 | 2,604,367 | 1,887,676 | 1,949,721 | ||||||||||||
Financial assets at fair value through profit or loss |
13 | 50,000 | 50,000 | 100,000 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total non-current assets |
2,838,817 | 2,131,051 | 2,268,596 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Current assets |
||||||||||||||||
Cash and cash equivalents |
15 | 848,854 | 2,052,922 | 3,133,482 | ||||||||||||
Corporate tax receivables |
514,698 | 502,585 | 711,934 | |||||||||||||
Trade and other receivables |
14 | 15,746,374 | 13,856,170 | 7,483,677 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total current assets |
17,109,926 | 16,411,677 | 11,329,093 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total assets |
19,948,743 | 18,542,728 | 13,597,689 | |||||||||||||
|
|
|
|
|
|
|||||||||||
EQUITY AND LIABILITIES |
||||||||||||||||
Equity attributable to owners of the parent |
||||||||||||||||
Share capital ordinary |
19 | 604,694 | 604,694 | 604,694 | ||||||||||||
Capital reserves |
19 | 28,599,822 | 28,599,822 | 28,599,822 | ||||||||||||
Share-based payment |
22 | 3,171,248 | 3,140,934 | 3,083,838 | ||||||||||||
Foreign exchange reserve |
19 | (411,990 | ) | 14,290 | (58,386 | ) | ||||||||||
Accumulated losses |
19 | (32,532,857 | ) | (33,836,306 | ) | (28,328,236 | ) | |||||||||
|
|
|
|
|
|
|||||||||||
Total equity |
(569,083 | ) | (1,476,566 | ) | 3,901,732 | |||||||||||
|
|
|
|
|
|
|||||||||||
Liabilities |
||||||||||||||||
Non-current liabilities |
||||||||||||||||
Deferred revenue |
5 | | 815,115 | | ||||||||||||
Lease liability |
18 | 413,657 | | | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total non-current liabilities |
413,657 | 815,115 | | |||||||||||||
|
|
|
|
|
|
|||||||||||
Current liabilities |
||||||||||||||||
Borrowings |
16 | 9,056,202 | 7,464,111 | 7,573,318 | ||||||||||||
Corporation tax payable |
229,690 | 198,059 | 48,142 | |||||||||||||
Deferred revenue |
5 | 6,257,849 | 9,023,106 | | ||||||||||||
Trade and other payables |
17 | 4,032,422 | 2,518,903 | 2,074,497 | ||||||||||||
Lease liability |
18 | 528,006 | | | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total current liabilities |
20,104,169 | 19,204,179 | 9,695,957 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total equity and liabilities |
19,948,743 | 18,542,728 | 13,597,689 | |||||||||||||
|
|
|
|
|
|
The accompanying notes form an integral part of these consolidated financial statements.
F-113
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Note |
Share
|
Capital
|
Share-
based
|
Foreign
|
Accumulated
|
Total equity |
||||||||||||||||||||||
Balance as of December 31, 2018 |
604,694 | 28,599,822 | 3,140,934 | 14,290 | (33,836,306 | ) | (1,476,566 | ) | ||||||||||||||||||||
Adoption of new accounting standard (note 2.4 ii) |
| | | | (62,438 | ) | (62,438 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Revised balance as of January 1, 2019 |
604,694 | 28,599,822 | 3,140,934 | 14,290 | (33,898,744 | ) | (1,539,004 | ) | ||||||||||||||||||||
Profit for the period ended May 6, 2019 |
| | | | 1,365,887 | 1,365,887 | ||||||||||||||||||||||
Other comprehensive loss |
| | | (426,280 | ) | | (426,280 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total comprehensive income |
| | | (426,280 | ) | 1,365,887 | 939,607 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Transactions with owners of the Company, recognized directly in equity |
||||||||||||||||||||||||||||
Share-based payments |
22 | | | 30,314 | | | 30,314 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance as of May 6, 2019 |
604,694 | 28,599,822 | 3,171,248 | (411,990 | ) | (32,532,857 | ) | (569,083 | ) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Note |
Share
|
Capital
|
Share-
based
|
Foreign
|
Accumulated
|
Total equity |
||||||||||||||||||||||
Balance as of December 31, 2017 |
604,694 | 28,599,822 | 3,083,838 | (58,386 | ) | (28,328,236 | ) | 3,901,732 | ||||||||||||||||||||
Adoption of new accounting standard (note 2.4 ii) |
| | | | (7,018,239 | ) | (7,018,239 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Revised balance as of January 1, 2018 |
604,694 | 28,599,822 | 3,083,838 | (58,386 | ) | (35,346,475 | ) | (3,116,507 | ) | |||||||||||||||||||
Profit for the year ended December 31, 2018 |
| | | | 1,510,169 | 1,510,169 | ||||||||||||||||||||||
Other comprehensive income |
| | | 72,676 | | 72,676 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total comprehensive income |
| | | 72,676 | 1,510,169 | 1,582,845 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Transactions with owners of the Company, recognized directly in equity |
||||||||||||||||||||||||||||
Share-based payments |
22 | | | 57,096 | | | 57,096 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance as of December 31, 2018 |
604,694 | 28,599,822 | 3,140,934 | 14,290 | (33,836,306 | ) | (1,476,566 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
F-114
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (CONTINUED)
Note |
Share
|
Capital
|
Share-
based
|
Foreign
|
Accumulated
|
Total equity |
||||||||||||||||||||||
Balance as of January 1, 2017 |
604,694 | 28,599,822 | 2,951,616 | (102,742 | ) | (28,465,574 | ) | 3,587,816 | ||||||||||||||||||||
Profit for the year ended December 31, 2017 |
| | | | 137,338 | 137,338 | ||||||||||||||||||||||
Other comprehensive income |
| | | 44,356 | | 44,356 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total comprehensive income |
| | | 44,356 | 137,338 | 181,694 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Transactions with owners of the Company, recognized directly in equity |
||||||||||||||||||||||||||||
Share-based payments |
22 | | | 132,222 | | | 132,222 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance as of December 31, 2017 |
604,694 | 28,599,822 | 3,083,838 | (58,386 | ) | (28,328,236 | ) | 3,901,732 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes form an integral part of these consolidated financial statements.
F-115
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Note |
Period ended May 6, 2019 |
Year ended
2018 |
Year ended
2017 |
|||||||||||||
Cash flows from operating activities |
||||||||||||||||
Profit/(loss) before taxes attributable to the owners of the parent |
1,415,271 | 1,315,015 | (88,063 | ) | ||||||||||||
Adjustments for: |
||||||||||||||||
Share-based payment expense |
22 | 30,314 | 57,096 | 132,222 | ||||||||||||
Net finance (income)/cost |
(16,028 | ) | 59,596 | 85,050 | ||||||||||||
Foreign exchange (gains)/losses |
(179,368 | ) | 194,481 | 117,854 | ||||||||||||
Amortization |
11 | 8,925 | 25,500 | 25,500 | ||||||||||||
Depreciation |
12 | 445,009 | 795,253 | 533,883 | ||||||||||||
Loss on disposal of fixed assets |
| 10,406 | | |||||||||||||
(Increase)/decrease in trade and other receivables |
14 | (1,890,204 | ) | 353,776 | (1,065,077 | ) | ||||||||||
Increase in trade and other payables |
17 | 1,513,519 | 444,406 | 328,230 | ||||||||||||
Change in deferred revenue |
5 | (3,580,372 | ) | 9,838,221 | | |||||||||||
Change in fair value of financial assets (FVTPL) |
13 | | 50,000 | | ||||||||||||
Adoption of new accounting standard* |
2.4 ii | | (7,018,239 | ) | | |||||||||||
|
|
|
|
|
|
|||||||||||
Cash (used in)/generated from operating activities |
(2,252,934 | ) | 6,125,511 | 69,599 | ||||||||||||
Corporation tax received/(paid) |
| 554,433 | (342,546 | ) | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net cash flows (used in)/generated from operating activities |
(2,252,934 | ) | 6,679,944 | (272,947 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Cash flows generated from/(used in) investing activities: |
||||||||||||||||
Payments to acquire property, plant and equipment |
12 | (13,930 | ) | (772,132 | ) | (962,811 | ) | |||||||||
Issue of loan to related party |
24 | | (6,889,366 | ) | (5,622,335 | ) | ||||||||||
Repayment of loan granted to related party |
24 | | | 2,273,764 | ||||||||||||
Proceeds from sale of assets |
| | 100,000 | |||||||||||||
Payment to acquire assets |
| | (100,000 | ) | ||||||||||||
Interest received |
140,994 | 143,715 | 94,462 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Net cash flows generated from/ (used in) investing activities |
127,064 | (7,517,783 | ) | (4,216,920 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Cash flows generated from/ (used in) financing activities: |
||||||||||||||||
Proceeds from loans |
1,150,563 | | 2,360,367 | |||||||||||||
Lease interest paid |
18 | (10,233 | ) | | | |||||||||||
Interest paid |
(123,909 | ) | (217,148 | ) | (180,968 | ) | ||||||||||
Repayment of loans |
| | (100,000 | ) | ||||||||||||
Principal element of lease payments |
18 | (171,473 | ) | | | |||||||||||
|
|
|
|
|
|
|||||||||||
Net cash flows generated from /(used in) financing activities |
844,948 | (217,148 | ) | 2,079,399 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net decrease in cash and cash equivalents |
(1,280,922 | ) | (1,054,987 | ) | (2,410,468 | ) | ||||||||||
Cash and cash equivalents as of beginning of period |
2,052,922 | 3,133,482 | 5,548,417 | |||||||||||||
Foreign exchange gain/(loss) on cash and cash equivalents |
76,854 | (25,573 | ) | (4,467 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Cash and cash equivalents as of end of period |
15 | 848,854 | 2,052,922 | 3,133,482 | ||||||||||||
|
|
|
|
|
|
F-116
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
CONSOLIDATED STATEMENTS OF CASH FLOWS (CONTINUED)
The accompanying notes form an integral part of these consolidated financial statements.
Reconciliation of movement in liabilities from financing activities |
Period ended May 6, 2019 |
Year ended
2018 |
Year ended
2017 |
|||||||||
At 1 January |
7,464,111 | 7,573,318 | 5,602,669 | |||||||||
Cash flows |
844,948 | (217,148 | ) | 2,079,399 | ||||||||
Non-cash changes |
||||||||||||
Adoption of new accounting standard (see note 2) |
1,025,736 | | | |||||||||
Foreign exchange |
561,218 | (115,436 | ) | (302,666 | ) | |||||||
Interest charged |
101,852 | 223,377 | 193,916 | |||||||||
|
|
|
|
|
|
|||||||
At May 6/ December 31 |
9,997,865 | 7,464,111 | 7,573,318 | |||||||||
|
|
|
|
|
|
The accompanying notes form an integral part of these consolidated financial statements.
F-117
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Notes to the Consolidated Financial Statements
1. General information
F-star Biotechnologische Forschungs- und Entwicklungsges.m.b.H. (F-star GmbH) is a private limited company incorporated in Austria as Gesellschaft mit beschränkter Haftung. F-star GmbH is the ultimate parent company of its wholly owned subsidiary, F-star Biotechnology Limited (F-star Biotechnology Limited) a private limited company incorporated in the United Kingdom, and the wholly-owned subsidiary of F-star Biotechnology Limited, F-star Therapeutics LLC (F-star LLC), a Limited Liability Company incorporated on January 23, 2019, in the state of Delaware in the United States. The three entities are together referred to as the group. Accordingly, the group prepares consolidated financial statements.
The activity of the group is research and development (R&D) within the biotechnology sector, especially the discovery of bispecific antibody products to improve the treatment of serious diseases. This business includes the granting and purchase of licenses and the sale of products and technologies within the biotechnology sector.
All amounts are in denominated in euros unless otherwise stated.
These consolidated financial statements were authorized for issue by the board of directors on August 28, 2020.
2. Summary of significant accounting policies
The principal accounting policies applied in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.
2.1 Basis of preparation
These consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) and IFRS Interpretations Committee (IFRS IC) as issued by the International Accounting Standards Board (IASB).
These financial statements have been prepared under the historical cost convention, modified to include revaluation to fair value of certain financial instruments at fair value through profit or loss, as described below.
During the comparative year, the group changed from preparation of consolidated financial statements under IFRS as adopted by the European Union to IFRS as adopted by the IASB. Management has considered the impact on the comparative figures reported and did not identify any areas where adjustment or restatement is required.
Consolidation
The group controls an entity when the group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the group. They are deconsolidated from the date that control ceases.
The group is currently comprised of (i) the parent company F-star GmbH, Vienna, (ii) its 100% owned subsidiary F-star Biotechnology Limited, Cambridge, United Kingdom and (iii) the wholly-owned subsidiary of F-star Biotechnology Limited, F-star Therapeutics LLC, Delaware, United States.
Intercompany transactions, balances, income, and expenses on transactions between group companies are eliminated. Profits and losses resulting from intercompany transactions that are recognized in assets are also eliminated.
Associates are all entities over which the group has significant influence but not control, generally accompanying a shareholding of between 20% and 50% of the voting rights. F-star GmbH, Vienna, holds 20% of the participation rights of each of two entities: S-TARget therapeutics GmbH, Vienna and OncoQR ML GmbH,
F-118
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Vienna. The group is also entitled to a share in dividend income or proceeds on sale from each of these entities but has no voting rights. Nevertheless, the group does not exercise significant influence. Therefore, the investment is accounted for according to IFRS 9 Financial Instruments.
The date of the statements of financial position of all consolidated entities is May 6, 2019 and December 31, 2018 and 2017.
Revision of tax reconciliation disclosures
The previously reported tax reconciliation disclosures for the years ended December 31, 2018 and 2017 have been revised in these financial statements for the correction of an immaterial error (see note 4.5).
2.2 Going concern
As of August 28, 2020, the date of approval of the consolidated financial statements for the period ended May 6, 2019, the group does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about the groups ability to continue as a going concern.
F-star Therapeutics Limited expects to seek equity financing from existing and new investors in conjunction with the contemplated Share Exchange Agreement entered into on July 29, 2020 between F-star Therapeutics Limited and Spring Bank Pharmaceuticals Inc. The closing of the Share Exchange Agreement would provide access to the existing cash deposits of Spring Bank Pharmaceuticals Inc as well as expected additional equity financing to be raised by F-star Therapeutics Limited as part of the Exchange. The estimated closing is anticipated in Q4 2020. The closing of the Share Exchange Agreement is however subject to approval by the shareholders of Spring Bank Pharmaceuticals Inc. If the merger is unsuccessful, F-star Therapeutics Limited will seek additional funding through equity financing from existing shareholders, or other alternative sources, which the directors believe can be obtained. Accordingly, the directors believe it is appropriate to continue to adopt the going concern basis of accounting. The financial statements do not include any adjustments that would be necessary if the group headed by F-star Therapeutics Limited and the group were unable to continue as a going concern.
F-star Therapeutics Limited, the parent undertaking has provided a letter of support to the group, committing to provide funding for operations for at least 12 months from the issuance date of these financial statements. As F-star Therapeutics Limited has insufficient cash to fund the groups operations for at least the next 12 months, the provision of this support is contingent upon successful fundraising.
2.3 Estimates and judgments
In the application of the groups accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are relevant. Actual results may differ from these estimates. See note 4 for details of critical estimates and judgments.
2.4 New standards, amendments and IFRIC interpretations
New standards, amendments and interpretations adopted by the group
The group has adopted all relevant IFRSs that were effective for periods beginning January 1, 2018. The following standards have been adopted by the group for the first time for the fiscal year beginning on or after January 1, 2019:
i. IFRS 9 Financial Instruments
IFRS 9 replaces the provisions of IAS 39 that relate to the recognition, classification and measurement of financial assets and financial liabilities; derecognition of financial instruments; and impairment of financial
F-119
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
assets and hedge accounting. IFRS 9 contains three principal classification categories for financial assets, measured as amortized cost, fair value through other comprehensive income and fair value through profit and loss. The classification of financial assets is generally based on the business model under which a financial asset is managed, and its contractual cash flow characteristics.
On January 1, 2018 (the date of initial application of IFRS 9), the groups management assessed which business models apply to the financial assets held by the group and classified its financial instruments into the appropriate IFRS 9 categories. The main effects resulting from this reclassification were as follows:
|
Note |
Original classification
under IAS 39 |
New
classification under IFRS 9 |
Original carrying
amount under IAS 39 |
New carrying
amount under IFRS 9 |
|||||||||||||||
Financial assets |
||||||||||||||||||||
Trade and other receivables |
(a) |
|
Loans and
receivables |
|
|
Amortized
cost |
|
2,405,424 | 2,405,424 | |||||||||||
Cash and cash equivalents |
|
Loans and
receivables |
|
|
Amortized
cost |
|
|
3,133,482 |
|
3,133,482 | ||||||||||
Loan to related party |
(b) |
|
Loans and
receivables |
|
|
Amortized
cost |
|
|
4,438,735 |
|
4,438,735 | |||||||||
Equity securities |
(c) | Available-for-sale |
|
FVTPL
equity instrument |
|
100,000 | 100,000 | |||||||||||||
|
|
|
|
|||||||||||||||||
Total Financial Assets |
10,077,641 | 10,077,641 | ||||||||||||||||||
|
|
|
|
|||||||||||||||||
Financial liabilities |
||||||||||||||||||||
Trade payables and accruals |
|
Other financial
liabilities |
|
|
Amortized
cost |
|
1,582,402 | 1,582,402 | ||||||||||||
Loan from related party |
(d) |
|
Other financial
liabilities |
|
|
Amortized
cost |
|
7,573,318 | 7,573,318 | |||||||||||
|
|
|
|
|||||||||||||||||
Total Financial Liabilities |
9,155,720 | 9,155,720 | ||||||||||||||||||
|
|
|
|
(a) |
Trade and other receivables: Trade and other receivables that were classified as loans and receivables under IAS 39 are now classified as amortized cost. The group applies the IFRS 9 simplified approach to measuring expected credit losses, which uses a lifetime expected loss allowance for all trade receivables and contract assets. |
(b) |
Loan to related party: Loans to related parties that were classified as loans and receivables under IAS 39 are now classified as amortized cost. The loan is repayable on demand and so the group applies an expected credit losses model on assumption that repayment is demanded as of the reporting date. |
(c) |
Equity securities: These investments have been reclassified from available-for sale to fair value through profit and loss. They do not meet the IFRS 9 criteria for classification at amortized cost, because their cash flows do not represent solely payments of principal and interest. |
(d) |
Trade payables and accruals and loan from related party: IFRS 9 largely retains the existing requirements in IAS 39 for the classification and measurement of financial liabilities. |
There are no changes in carrying value due to reclassification or remeasurement of financial assets on adoption of IFRS 9 on January 1, 2018. For assets held at amortized cost, no additional impairments were identified by management that would be material. For equity investments held at fair value through profit or loss (FVPL), the difference between the IAS 39 allowed treatment of carrying at cost and the IFRS 9 fair value valuation method was immaterial.
F-120
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
IFRS 9 replaces the incurred loss model in IAS 39 with expected credit loss (ECL) model. The new impairment model applies to financial assets measured at amortized cost, contract assets and debt investments at FVOCI, but not to investments in equity instruments. Under IFRS 9, credit losses are recognized earlier than under IAS 39.
For assets in the scope of the IFRS 9 impairment model, the impairment losses are generally expected to increase and become more volatile. The group has determined that impairments arising from the application of the IFRS 9 requirements as of January 1, 2018 would be immaterial.
Full details of the Financial Instruments accounting policy effective from January 1, 2018 are included in section m. of this note.
ii. IFRS15 Revenue from Contracts with Customers
The group has adopted IFRS 15 Revenue from Contracts with Customers on a modified retrospective basis from January 1, 2018. Under IAS 18, in both the arrangement with an external customer and arrangement with F-star Beta Limited, the license and R&D were two separate components because the commercial effect was separate. The group assessed the license and R&D services under IFRS 15 distinct criteria and concluded the R&D services were significantly modifying the license and as such were a combined performance obligation. A cost-to-cost method to measure progress of completion of the performance obligation has been used to assess the revenue to be recognized at each reporting date. This has resulted in the following changes to the financial statements:
Statement of financial position (extract) |
IAS 18 carrying
December 31, 2017 |
Remeasurement |
IFRS 15 carrying
January 1, 2018
|
|||||||||
Deferred revenue |
| 7,018,239 | 7,018,239 |
The impact on the groups accumulated losses as at January 1, 2018 is as follows:
| ||||
Balance as at December 31, 2017 as originally stated |
(28,328,236 | ) | ||
Change in accounting policy |
(7,018,239 | ) | ||
|
|
|||
Restated total equity as at January 1, 2018 |
(35,346,475 | ) | ||
|
|
Under IAS 18, 21.3 million would have been recognized in the statement of comprehensive income for the year ended December 31, 2018, in relation to the both arrangements.
The new accounting policies adopted by the group as of January 1, 2018 are included in section l. of this note.
iii. IFRS16 Leases
The group has adopted IFRS 16 Leases retrospectively from January 1, 2019 but has not restated comparatives for the 2018 reporting period, as permitted under the specific transition provisions in the standard. The reclassifications and the adjustments arising from the new leasing rules are therefore recognized in the opening balance sheet on January 1, 2019.
The new accounting policies are disclosed in note 2.19.
On adoption of IFRS 16, the group recognized lease liabilities in relation to leases which had previously been classified as operating leases under the principles of IAS 17 Leases. These liabilities were measured at the present value of the remaining lease payments, discounted using the lessees incremental borrowing rate as of January 1, 2019. The weighted average lessees incremental borrowing rate applied to the lease liabilities on January 1, 2019 was 2.97%.
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F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Management has elected to apply IFRS 16 using a modified retrospective transition method and has elected to apply the following practical expedients:
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application of a single discount rate to a portfolio of leases with reasonably similar characteristics |
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reliance on previous assessments on whether leases are onerous as an alternative to performing an impairment review there were no onerous contracts as at January 1, 2019 |
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accounting for operating leases with a remaining lease term of less than 12 months as at January 1, 2019 as short-term leases |
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use of hindsight in determining the lease term where the contract contains options to extend or terminate the lease |
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elect to not separate lease and non-lease components and instead account for both as if it were one lease component |
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payments associated with short-term leases of equipment and vehicles and all leases of low value assets are recognized on a straight-line basis as an expense in profit or loss. |
Of the leases, 26.2 thousand relate to short-term lease commitments, which will be recognized on a straight-line basis as an expense in the consolidated statements of comprehensive income. The remaining leases relate to long-term property leases.
Measurement of lease liabilities
| ||||
Operating lease commitments disclosed as at December 31, 2018 |
1,110,576 | |||
Effect of discounting those lease commitments at an annual discount rate of 5% |
(80,635 | ) | ||
Less short-term leases not recognized as a liability |
(26,197 | ) | ||
|
|
|||
Lease liability recognized as at January 1, 2019 |
1,003,744 | |||
|
|
Adjustments recognized in the consolidated statement of financial position on January 1, 2019
The adoption of a new accounting policy affected the following items in the consolidated statement of financial position on January 1, 2019:
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right-of-use assets increase by 941,306 |
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lease liability increase by 1,003,744 |
The net impact on net assets and retained earnings on January 1, 2019 was a decrease of 62,438.
The group does not act as a lessor.
There are no other IFRSs or IFRIC interpretations that are not yet effective that would be expected to have a material impact on the group.
2.5 Foreign currency translation
Functional and presentational currency
The consolidated financial statements are presented in euros, which is the groups presentation currency. Items included in the consolidated financial statements of each of the groups entities are measured using the currency of the primary economic environment in which the entity operates (the functional currency). Functional currencies of the consolidated entities are as follows:
F-star Biotechnology Limited, Cambridge, U.K. | pounds sterling | |
F-star Therapeutics LLC, Delaware, U.S. | U.S. dollar |
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The results and financial position of all group entities (none of which has the currency of a hyper-inflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:
a. |
assets and liabilities for each date of consolidated statements of financial position presented are translated at the closing rate as of the date of that consolidated statement of financial position; |
b. |
income and expenses for each consolidated statement of comprehensive income are translated at average exchange rates (unless this average is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the rate on the dates of the transactions); and |
c. |
all resulting exchange differences are recognized in other comprehensive income. |
Transactions and balances
Foreign currency transactions are translated into euros, the groups functional currency, using the exchange rates prevailing at the date of the transactions or valuation where items are remeasured. Foreign exchange gains and losses resulting from the settlement of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statement of comprehensive income. Foreign exchange gains and losses that relate to borrowings and cash and cash equivalents are presented in the statement of comprehensive income within finance income or costs. All other foreign exchange gains and losses are presented within other gains in the consolidated statement of comprehensive income.
2.6 Property, plant and equipment
Items of property, plant and equipment are measured at cost less accumulated depreciation and any accumulated impairment losses. If significant parts of an item of property, plant and equipment have different useful lives, then they are accounted for as separate items. Subsequent expenditure is capitalized only if it is probable that the future economic benefits associated with the expenditure will flow to the group.
Expenditure on repairs and maintenance is charged to the consolidated statement of comprehensive income as incurred. Cost and related accumulated depreciation of property, plant and equipment sold or otherwise disposed of are derecognized and any gain or loss is reported as current years income or expense. Currently, no borrowing costs are added to the costs of assets as the group has not acquired or constructed assets that necessarily take a substantial period of time to get ready for their intended use or sale (qualifying assets).
Depreciation is charged so as to write off the cost of the assets over their estimated useful economic lives, using the straight-line method, on the following basis:
Leasehold property improvements, right of use assets | Lesser of useful life or period of the lease | |
Plant and machinery | 20% on cost | |
Office equipment, fixtures and fittings | 33% on cost |
Depreciation methods, useful lives and residual values are reviewed as of each reporting date and adjusted, if appropriate.
2.7 Intangible assets
Expenditure on research activities are recognized in the consolidated statement of comprehensive income as incurred. Development expenditure is capitalized only if the expenditure can be measured reliably, the product is technically and commercially feasible, future economic benefits are probable, and the group has sufficient resources to complete or sell the asset.
Acquired intangible assets, including intellectual property rights that have finite useful lives, are measured at cost less accumulated amortization and any accumulated impairment losses.
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Subsequent expenditure is capitalized only when it increases the future economic benefits of the asset to which it relates. All other expenditure is recognized in the consolidated statements of comprehensive income as incurred.
Intangible assets are amortized over their estimated useful economic lives, using the straight-line method:
|
Patents (once filed)Over the period of the relevant patents (assumed to be 20 years once filed) |
2.7 Impairment of non-financial assets
At the date of the consolidated statement of financial position, the group reviews the carrying amounts of its long-lived assets to determine whether there is any indication that those assets have suffered an impairment loss.
For the purpose of measuring recoverable amounts, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units or CGUs). The recoverable amount is the higher of fair value less cost of disposal and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the estimates of future cash flows have not been adjusted.
If the recoverable amount of an asset is estimated to be less than its carrying amount, the carrying amount of the asset is reduced to its recoverable amount. An impairment loss is recognized as part of operating expenses immediately.
2.8 Financial instruments
i. Financial assets
Classification
The group classifies its financial assets in the following measurement categories:
|
measured at fair value |
|
measured at amortized cost |
The classification depends on the groups business model for managing the financial assets and the contractual terms of the cash flows. For assets measured at fair value, gains and losses are recorded in profit or loss.
The group has financial assets held at fair value through profit or loss, these comprise of unlisted participation rights. Financial assets at amortized cost include Trade and other receivables and Cash and cash equivalents and Other receivables excluding prepayments and other non-financial receivables.
Recognition and derecognition
Financial assets are derecognized when the right to receive cash flows from the financial assets has expired or has been transferred and the group has transferred substantially all the risks and rewards of ownership.
Measurement
At initial recognition, the group measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss (FVPL), transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets carried at FVPL are expensed in the consolidated statement of comprehensive income. The group subsequently measures all equity investments at fair value. Changes in the fair value of financial assets at FVPL are recognized in other income or other expenses in the consolidated statements of comprehensive income as applicable.
Subsequent measurement of receivables depends on the groups business model for managing the asset and the cash flow characteristics of the asset. Assets that are held for collection of contractual cash flows where those
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cash flows represent solely payments of principal and interest are measured at amortized cost. As of December 31, 2018, and May 6, 2019, all receivables in the group are held at amortized cost. Interest income from these financial assets is included in finance income using the effective interest rate method. Any gain or loss arising on derecognition is recognized directly in the consolidated statement of comprehensive income and presented in other income or other expenses together with foreign exchange gains and losses. Impairment losses are presented as a separate line item in the consolidated statement of comprehensive income to the extent such charges have been recorded.
Impairment
The group assesses on a forward-looking basis the expected credit loss associated with its debt instruments carried at amortized cost. The impairment methodology applied depends on whether there has been a significant increase in credit risk. For trade receivables the group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognized from initial recognition of the receivables. Management determines the classification of its financial assets and liabilities at initial recognition.
The loss allowances for financial assets are based on management assumptions about risk of default and expected loss rates. Management uses judgment in making these assumptions and selecting inputs to impairment calculations based on past history, external conditions, and forward-looking estimates.
The group does not use derivative instruments to reduce the exposure to foreign exchange risk.
ii. Financial liabilities
Financial liabilities at amortized cost include trade payables, lease liability and other payables excluding non-financial liabilities. Trade payables are initially recognized at the amount required to be paid. Subsequently, trade payables are measured at amortized cost, which approximates the fair value due to the short-term nature of these liabilities.
Borrowing costs primarily comprise interest on borrowings from banks and other financial institutions. All borrowing costs are expensed in the period in which they are incurred. Note 2.13 sets out the accounting policy for bank debt and other borrowings.
2.9 Offsetting financial instruments
Financial assets and liabilities are reported at their net amount in the consolidated statements of financial position if there is a legally enforceable right of offset and there is an intention to settle. The legally enforceable right must not be contingent on future events and must be enforceable in the normal course of business and in the event of default, insolvency or bankruptcy of the group or the counterparty.
2.10 Trade and other receivables
Financial assets included in trade and other receivables are recognized initially at fair value. The group holds these receivables with the objective to collect the contractual cash flows and therefore measures them subsequently at amortized cost using the effective interest method, less any impairment losses. Prior to January 1, 2018 the group provided an allowance for uncollectable accounts based on prior experience and managements assessment of the collectability of existing specific accounts. From January 1, 2018, the group also assesses the expected credit losses associated with these financial assets on a forward-looking basis.
2.11 Cash and cash equivalents
Cash and cash equivalents comprise cash on hand and demand deposits and other short-term and highly liquid investments that are readily convertible to a known amount of cash and are subject to an insignificant risk of changes in value with original maturities of three months or less.
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2.12 Equity and reserves
The groups share capital is made up of share quotas representing a shareholding in the nominal amount subscribed for by the relevant shareholder. The shares have equal voting rights with each 1 of nominal amount subscribed for representing one vote. As of May 6, 2019, the groups share capital was divided on a contractual basis pursuant to a shareholders agreement into common shares and common shares with contractual preference rights. These common shares with contractual preference rights had a liquidation preference over other common shares. In addition, common shares with contractual preference rights had an anti-dilution protection that was not applicable for other common shares. Pursuant to Austrian law no holder of these common shares with contractual preference rights could require the group to pay cash, a financial asset or a variable number of the Companys shares. Hence, also the common shares with contractual preference rights were classified as equity. The capital reserve comprises all payments effected by shareholders of the group in their function as shareholders, e.g. share premiums on issue of share capital.
2.13 Borrowings
Interest-bearing borrowings are initially recognized at fair value less any related transaction costs. Subsequent to initial recognition, interest-bearing borrowings are stated at amortized cost. Any difference between cost and redemption value is recognized in the consolidated statements of comprehensive income over the entire period of the borrowings on an effective interest basis.
Interest-bearing borrowings are classified as current liabilities unless the group has an unconditional right to defer the settlement of the liability for at least twelve months from the date of these consolidated statements of financial position.
2.14 Trade and other payables
Trade and other payables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payable are classified as current liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities.
Deferred revenue
Payments for unsatisfied performance obligations to be completed in future periods are recorded in the consolidated statements of financial position as contract liabilities (deferred revenue).
2.15 Current and deferred income tax
The tax credit/charge represents the sum of the tax currently receivable/payable and deferred tax. The tax currently payable/receivable is based on taxable profit/loss for the year. Taxable profit/loss differs from net profit/loss as reported in the consolidated statements of comprehensive income because it excludes items of income or expense that are taxable or deductible in other years and it further excludes items that are never taxable or deductible. The groups asset/liability for current tax is calculated using tax rates that have been enacted or substantively enacted by the date of the consolidated statements of financial position.
R&D expenditure is written off in the year in which it is incurred. Any tax credit receivable under the small company R&D scheme is recognized in Income tax in the consolidated statements of comprehensive income.
Deferred tax is the tax expected to be payable or recoverable on differences between the carrying amounts of assets and liabilities in the consolidated financial statements and the corresponding tax bases used in the computation of taxable profit and is accounted for using the balance sheet liability method. Deferred tax liabilities are generally recognized for all taxable temporary differences and deferred tax assets are recognized to the extent that it is probable that taxable profits will be available against which deductible temporary differences
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can be utilized. Such assets and liabilities are not recognized if the temporary difference arises from the initial recognition of goodwill or from the initial recognition (other than in a business combination) of other assets and liabilities in a transaction, which affects neither the taxable profit nor the accounting profit.
Deferred tax liabilities are recognized for taxable temporary differences arising on investments in subsidiaries except where the group is able to control the reversal of the temporary difference and it is probable that the temporary difference will not reverse in the foreseeable future.
The carrying amount of deferred tax assets is reviewed as of the date of the consolidated statements of financial position and reduced to the extent that it is no longer probable that sufficient taxable profits will be available to allow all or part of the asset to be recovered. Deferred tax is calculated at the tax rates that are expected to apply in the period when the liability is settled, or the asset is realized. Deferred tax is charged or credited in the consolidated statements of comprehensive income, except when it relates to items charged or credited directly to equity, in which case the deferred tax is also dealt with in equity.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to set off current tax assets against current tax liabilities and when they relate to income taxes levied by the same taxation authority and the group intends to settle its current tax assets and liabilities on a net basis.
2.16 Post-employment benefits
The group pays contributions to defined contribution plans. The costs charged against profits represent the amount of the contributions payable to the scheme in respect of the accounting period.
2.17 Share-based payments
The group operates an equity-settled, share-based compensation plan, under which it issues equity instruments (options) of the parent company to employees of the parent company. The fair value of the services received in exchange for the grant of the options is recognized as an expense. The total amount to be expensed is determined by reference to the fair value of the options granted, excluding the impact of any service and non-market performance vesting conditions.
Non-market performance and service conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each reporting period, the group revises its estimate of the number of options that are expected to vest based on the non-market vesting and service conditions. It recognizes the impact of the revision to original estimates, if any, in the consolidated statements of comprehensive income, with a corresponding adjustment to equity.
2.18 Revenue recognition
The groups revenues are generated through its collaborative arrangement with one external collaborator and provision of intellectual property licenses and R&D services to one related party. The terms of the arrangement with the external collaborator include performing R&D services and the grant of intellectual property rights. In exchange for the initial grant of intellectual property rights and R&D services, the group has received non-refundable upfront license payments and is eligible to receive variable consideration in the form of milestone payments that are based on the achievement of defined collaboration objectives.
On inception of a new contract, management identifies performance obligations and consider if these performance obligations are distinct. Performance obligations are promised services in a contract to transfer a distinct service to the customer. Promised services are considered distinct when: (i) the customer can benefit from the service on its own or together with other readily available resources, and (ii) the promised service is separately identifiable from other promises in the contract. In assessing whether promised services are distinct, management considers factors such as the stage of development of the underlying intellectual property, the
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capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, management considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
For customer options to acquire intellectual property rights, management assesses if the optional future services are offered at the standalone selling price. If this is the case, then the option is not deemed to provide the customer with a material right and is not considered to be a separate performance obligation. In determining the standalone selling price management consider factors such as identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until the option is exercised or expires, whichever is earliest.
Management estimates the transaction price based on the amount of consideration that the group expects to receive for transferring the promised services in the contract and allocates the transaction price to each performance obligation based upon managements estimate of the standalone selling price. Management must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. Management utilizes key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts the group would expect to receive for each performance obligation.
For variable consideration, the group assesses the likelihood that a significant reversal of cumulative revenue will not occur, and amounts are recognized only if it is deemed to be highly probable that reversal will not occur. The group utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration expected to be received.
For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable. When R&D services income, license fees and milestone income are recognized over time, with resource expended to date as a measure of progress of the performance obligations identified in the contract for the following reasons:
|
each performance obligation contains multiple deliverables; and |
|
resource expended has been assessed as the most accurate method of measuring progress towards completion of each performance obligation. |
2.19 Leases
The group leases offices for a fixed period of 3 to 5 years. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. The lease agreements do not impose any covenants other than the security interests in the leased assets that are held by the lessor. Leased assets may not be used as security for borrowing purposes.
From January 1, 2019, on inception of any contract, management assesses whether that contract is, or contains, a lease. A contract is deemed to be, or deemed to contain, a lease, if the contract gives the group the right to control the use of an asset. To determine this, management assesses if:
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The contract involves the use of an identified asset |
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The group has the right to obtain substantially all of the economic benefits from the use of the asset throughout the period of use; and |
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The group controls the use of the asset, which can be indicated by either: |
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The group having the right to operate the asset. |
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The group having designed an asset in a way which predetermines how it will be used and for what purpose. |
Where a contract is deemed to be, or is deemed to contain, a lease, the group recognizes a right-of-use asset and a lease liability.
The right-of-use asset is initially measured at cost, which comprises the initial amount of the lease liability, adjusted for any lease payments made at or before the commencement date, plus any initial direct costs incurred and an estimate of costs to dismantle, remove or restore the underlying asset, less any lease incentives received. Right-of-use assets are generally depreciated over the shorter of the assets useful life and the lease term on a straight-line basis. If the group is reasonably certain to exercise a purchase option, the right-of-use asset is depreciated over the underlying assets useful life.
The lease liability is initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using the interest rate implicit in the lease, or if that rate cannot be readily determined, the groups incremental borrowing rate, being the rate that the individual lessee would have to pay to borrow the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar economic environment with similar terms, security and conditions. For all current leases the group has used the incremental borrowing rate as the discount rate. The liability is measured at amortized cost, using the effective interest method and remeasured when there is a change in future lease payments. When the liability is remeasured, a corresponding adjustment is made to the carrying amount of the right-of-use asset or recorded in the consolidated statement of comprehensive income if the carrying amount of the right-of-use asset has been reduced to zero.
The group is exposed to potential future increases in variable lease payments based on an index or rate, which are not included in the lease liability until they take effect. When adjustments to lease payments based on an index or rate take effect, the lease liability is reassessed and adjusted against the right-of-use asset.
Lease payments are allocated between principal and finance cost. The finance cost is charged to the profit and loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period.
Short-term leases and leases of low-value assets
The group has elected not to recognize low value leases and lease liabilities for short-term leases of office buildings that have a lease term of 12 months or less and leases of low-value assets, such as office equipment. The group recognizes the lease payments associated with these leases as an expense on a straight-line basis over the lease term.
2.21 Operating segments
The group consists of a single operating reporting segment as defined under IFRS 8 Operating Segments.
3. Financial risk management
3.1 Liquidity risk
Liquidity risk is the risk that the group will encounter difficulty in meeting its short-term obligations associated with financial liabilities.
Liquidity needs are monitored by the group using rolling forecasts to ensure it has sufficient funds to meet its liabilities when due, under normal and unexpected conditions, without incurring unacceptable losses.
The group is dependent upon receiving payments for services that it provides to its related party company, F-star Beta Limited which includes payments for employees carrying out research and ancillary administrative services.
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As of the signing date of these consolidated financial statements for the period ended May 6, 2019, the group will require additional financing to fund its operating expenses and capital expenditure requirements for at least the next 12 months (see note 2.2). The group may not be able to obtain financing on acceptable terms, or at all, and the group may not be able to enter into collaborations. The terms of any future financing may adversely affect the rights or interests of the groups shareholders. If the group is unable to obtain funding, the group could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects.
The table below analyses the groups financial liabilities (interest included) into relevant maturity groupings based on the remaining period at the consolidated statements of financial position date to the contractual maturity date.
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
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Payable in less than one year |
||||||||||||
Other borrowings |
9,056,202 | 7,464,111 | 7,573,318 | |||||||||
Other payables |
1,139,884 | 788,349 | 1,198,578 | |||||||||
Lease liability |
563,098 | | | |||||||||
|
|
|
|
|
|
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10,759,184 | 8,252,460 | 8,771,896 | ||||||||||
Payable in one to two years |
||||||||||||
Lease liability |
422,323 | | | |||||||||
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|
|
|
|
|
|||||||
422,323 | | | ||||||||||
|
|
|
|
|
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Total financial liabilities |
11,181,507 | 8,252,460 | 8,771,896 | |||||||||
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|
|
|
|
|
3.2 Interest rate risk
Interest rate risk is the risk that the changes in market interest rates will cause fluctuations to the fair values and cash flows of the groups financial instrument holdings.
The group is exposed to changes in market interest rates through a loan to F-star Beta Limited, its bank deposits and borrowings from F-star Alpha Limited, which are subject to variable interest rates. All other financial assets and liabilities have fixed rates.
An increase in the interest rate by 1% would result in a decrease of financial result by 9,441 in the period ended May 6, 2019 and 22,598 in the year ended December 31, 2018 (2017: decrease of 28,604). Based on the current market conditions, the group does not expect significant changes in the level of interest rates.
3.3 Currency risk
The group undertakes transactions denominated in foreign currencies and as such is exposed to price risk due to fluctuations in foreign exchange rates. The group does not use derivative instruments to reduce exposure to foreign exchange risk.
Currency risk is the risk that the changes in foreign exchange rates will cause fluctuations in the fair values and cash flows of the groups financial instrument holdings. Foreign exchange risk arises when future recognized assets or liabilities are denominated in a currency that is not the entitys functional currency.
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The group considers its currency risk to be moderate and states the following net position in foreign currencies other than the functional currency of the entities as per May 6, 2019, December 31, 2018 and December 31, 2017:
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
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U.S dollars |
46,964 | 542,514 | (88,731 | ) | ||||||||
Pounds sterling |
50,043 | 8,315 | 3,685,131 | |||||||||
Euros |
64,891 | 673,352 | 21,379 |
The following table illustrates the sensitivity of the change in cash and trade and other receivables and trade and other payables and the net profit (loss) for the period and equity to a reasonably possible change in exchange rates of 10%, with effect from the beginning of the period. These changes are considered to be reasonably possible based on the observation of current market conditions. The calculations are based on the groups financial instruments held at each date of consolidated statements of financial position. All other variables are held constant.
Effect on net result of the period/equity | ||||||||||||
May 6,
|
December 31,
|
December 31,
|
||||||||||
Exchange Rate +10% |
||||||||||||
U.S dollars |
3,053 | 7,844 | 11,375 | |||||||||
Pounds sterling |
5,004 | 832 | 56,964 | |||||||||
Euros |
5,017 | 1,113 | 4,619 |
3.4 Credit risk
Credit risk is the risk of financial loss to the group if the counterparty fails to meet its obligations.
Credit risk arises from the groups operating activities from receivables, financing activities from cash and cash equivalents and deposits with banks and financial institutions.
The group has one external customer (all other sales are made to related parties). The group closely monitors the performance conditions under the contract with the customer ensuring that invoices are raised when performance conditions are met and that the payments terms with the customer are adhered to.
Credit risk from receivables is minimized by establishing credit policies such as determining and monitoring customer credit limits, requiring credit approvals and the monitoring of customer credit risks. Other monitoring procedures are in place to recover overdue customer accounts and to assess impairment.
Credit risk from financing activities is minimized by establishing investment policies in liquid securities with high credit ratings and maintaining accounts in reputable financial institutions with high quality credit ratings. All cash held by the group is with financial institutions with a credit rating of F1+ or AA- according to Fitchs short term and long-term credit ratings.
3.5 Impairment of financial assets
Amounts due from related parties
The group applies the IFRS 9 simplified approach to measuring expected credit losses for amounts due from related parties, which uses a lifetime expected loss allowance for amounts due from related parties. The expected loss rates are based on the payment profile of the groups customers over their entire trading history.
The historical loss rate is zero but has been adjusted to reflect current and forward-looking information on macroeconomic factors affecting the ability of the customers to settle the receivable.
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Amounts due from related parties are written off when there is no reasonable expectation of recovery. Indicators that there is no reasonable expectation of recovery include, amongst others, failure of a debtor to engage in a repayment plan and failure to make contractual payments for greater than 120 days past due.
While cash and cash equivalents and recoverable VAT are also subject to the impairment requirements of IFRS 9 the identified impairment loss was immaterial.
Impairment on trade and other receivables and contract assets are presented as net impairment losses within operating profit. Subsequent recoveries of amounts previously written off are credited against the same line item.
Loan due from related party
The group has applied an expected credit losses model to assess if impairment of the amount owing from related party is required at the reporting date and the date of IFRS 9 adoption. The terms of the loan dictate that the full balance is repayable on demand and therefore the expected credit losses are based on the assumption that repayment in full is demanded at the reporting date. Management reviewed the liquid asset position of the related party (F-star Beta Limited) at May 6, 2019, December 31, 2018 and January 1, 2018 (date of adoption of IFRS 9) and it was determined that the related party did not have sufficient liquid assets to repay the loan at any of these dates. Due to the related party status of the recipient of the loan, management have access to detailed forecasts and were able to estimate the value of intellectual property held by the related party, but not held in the consolidated statements of financial position at May 6, 2019, December 31, 2018 and January 1, 2018. This was calculated on a risk-adjusted, discounted cash flow basis taking into consideration macroeconomic factors. Management assessed the ability of the related party to monetarize the intellectual property in order to repay the debt at all dates and determined that any impairment of the loan would be immaterial.
4. Critical accounting estimates and judgments
Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances.
The group makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are addressed below.
In the application of the groups accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.
4.1 Assessment of control under IFRS 10 judgment
Management has made an assessment of whether F-star Biotechnology Limited (Biotech) controls the following related party entities: F-star Alpha Limited, F-star Beta Limited or F-star Delta Limited under IFRS 10, Consolidated financial statements. This has required management to exercise significant judgment. On the basis of the assessment set out below, management has concluded that the company does not control F-star Alpha Limited, F-star Beta Limited or F-star Delta Limited and consequently, these companies have not been consolidated into these consolidated financial statements.
Under IFRS 10, an investor controls an investee if, and only if, the investor has power over the investee; exposure, or rights, to variable returns from its involvement with the investee; and, the ability to use its power over the investee to affect the amount of the investors returns. An investor has power over an investee when the investor has existing rights that give it the current ability to direct the relevant activities, i.e. the relevant activities that significantly affect the investees returns.
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F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Although Biotech has no equity investment in F-star Alpha Limited, F-star Beta Limited or F-star Delta Limited there are common shareholders with Biotechs parent company, F-star GmbH.
The relevant activities of F-star Beta Limited and F-star Delta Limited are the direction of R&D activities for the discovery and development of antibody product candidates designed to treat serious diseases. An over-arching legal agreement exists in the case of F-star Beta Limited and F-star Delta Limited with an unrelated pharmaceutical company. It is this legal agreement, which determines the expected returns, which may result from the development programmes. Biotech is consequently unable to affect the returns as stipulated in the legal agreements. Biotechs only involvement in those agreements is to provide services to F-star Beta Limited and F-star Delta Limited at pre-specified rates. Therefore, management consider that Biotech is unable to control the activities of F-star Beta Limited or F-star Delta Limited.
F-star Alpha Limited incurs corporate costs and holds the exclusive intellectual property rights to certain programs. There are no transactions with F-star Alpha Limited, which would suggest Biotech has the power to direct its relevant activities and therefore management has concluded Biotech should not consolidate F-star Alpha Limited.
4.2 Judgments and estimates utilized to determine the amount and timing of revenue recognition
License and collaboration agreement with Denali
The group has a license and collaboration agreement with Denali Therapeutics Inc. (Denali) under which it supplies intellectual property rights, the option to acquire further rights and R&D services to develop a number of therapeutic molecules. The group is also eligible to receive milestone payments if certain stages of development, regulatory approval and annual product sales are achieved. The contract includes multiple promises, however the intellectual property licensing and R&D services supplied are not deemed to be separate performance obligations. This is because the intellectual property rights granted are expected to be significantly modified by the R&D services also provided by the group. The option to acquire further rights is not considered to be a material right, as the option does not provide Denali with a discount that it would not have otherwise received. This is therefore deemed to not be a separate performance obligation.
Revenue from the grant of intellectual property rights and R&D services provided as part of this arrangement are recognized using the cost-to-cost method to measure progress of completion of the performance obligation, which utilizes the total cost of labor incurred to the reporting date, relative to the total expected cost.
Success-based milestones represent variable consideration which is included in the transaction price only when it is highly probable that a significant reversal of cumulative recognized revenue will not occur. Standard payment terms of the contract are payment within 30 days.
Intellectual property licensing and services agreement with F-star Beta Limited
Management assessed that the R&D services are not distinct from the transfer of intellectual property rights, and therefore together they constitute a single combined performance obligation.
The consideration for intellectual property licensing and services agreement is variable. At inception of the contract, management evaluated the total amount of consideration and the likelihood that each payment would be received. The amount included in the transaction price was constrained to the amount for which it is highly probable that a significant reversal of cumulative revenue recognized will not occur. At each reporting date management evaluate whether milestones and R&D services are considered highly probable of being reached and, to the extent that a significant reversal would not occur in future periods, estimate the amount to be included in the transaction price using the most likely amount method. There are no provisions in the existing agreement for returns or refunds.
The group recognizes revenue using the cost-to-cost method, which it believes best depicts the transfer of control of the services to the customer. Under the cost-to-cost method, the extent of progress towards completion is
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F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation.
For arrangements that include sales-based royalties and sales-based milestones and in which the license is deemed to be the predominant item to which the royalties relate, the group recognizes royalty revenue upon the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Standard payment terms of the contract are payment within 30 days.
4.3 Impairment of financial assets
The loss allowances for financial assets are based on management assumptions about risk of default and expected loss rates. Management uses judgement in making these assumptions and selecting inputs to impairment calculations based on past history, external conditions, and forward-looking estimates.
4.4 Other estimates share based payments
A share option compensation charge has been recognized in respect of share options granted. There are a number of subjective inputs into the calculation of the charge, the most significant of which is the share price on the date of grant. As an unlisted group, this is subject to a significant degree of estimation uncertainty. Management estimate the share price by modelling of the net present value of the future discounted cash flows of the group as applied to the number of shares in issue.
4.5 Revision of Previously Issued Financial Statements
During the course of preparing the May 6, 2019 financial statements, financial management became aware of misstatements in the tax note, and effects of tax note, of the audited financial statements for the financial years ended 2018 and 2017, which came to light when preparing the May 6, 2019, tax note. The group assessed the effect of the above adjustments in the prior periods financial statements in accordance with the SECs Staff Accounting Bulletins No. 99 and 108 and, based on an analysis of quantitative and qualitative factors, determined that these were not material to any of the groups prior annual financial statements. All financial information contained in the accompanying notes has been revised to reflect the correction of this immaterial error.
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F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
The following tables present the effect of the aforementioned revision:
Consolidated statements of comprehensive income (extract) |
As
2018 |
Adjustment 2018 |
As revised 2018 |
|||||||||
Profit before tax |
1,315,015 | | 1,315,015 | |||||||||
Profit before tax multiplied by the prevailing rate of Austrian corporation tax for the period 2018 of 25% |
328,754 | (657,508 | ) | (328,754 | ) | |||||||
EFFECTS OF: |
||||||||||||
Different tax rates in subsidiaries |
195,935 | (429,966 | ) | (234,031 | ) | |||||||
Expenses directly recognised in equity |
12,658 | (25,316 | ) | (12,658 | ) | |||||||
Additional deduction for R&D expenditure |
(378,528 | ) | 757,056 | 378,528 | ||||||||
Surrender of tax losses for repayable R&D credits |
158,614 | (951,177 | ) | (792,563 | ) | |||||||
R&D tax credits |
| 511,089 | 511,089 | |||||||||
Change in deferred tax assets not recognised |
(1,522,068 | ) | 1,522,068 | | ||||||||
Impact of change in accounting policy |
1,333,465 | (1,547,740 | ) | (214,275 | ) | |||||||
Utilisation of brought forward tax losses |
| 916,206 | 916,206 | |||||||||
Other effects |
65,930 | (94,712 | ) | (28,782 | ) | |||||||
|
|
|
|
|
|
|||||||
Tax credit for the current year |
194,760 | | 194,760 | |||||||||
Tax related to previous period |
394 | | 394 | |||||||||
|
|
|
|
|
|
|||||||
Total tax credit |
195,154 | | 195,154 | |||||||||
|
|
|
|
|
|
Consolidated statements of comprehensive income (extract) |
As
2017 |
Adjustment 2017 |
As revised 2017 |
|||||||||
Corporate tax credit current period |
210,809 | 29,184 | 239,993 | |||||||||
Corporate tax prior periods |
14,592 | (29,184 | ) | (14,592 | ) | |||||||
|
|
|
|
|
|
|||||||
Total credit |
225,401 | | 225,401 | |||||||||
|
|
|
|
|
|
|||||||
Loss before tax |
(88,063 | ) | | (88,063 | ) | |||||||
Profit before tax multiplied by the prevailing rate of Austrian corporation tax for the period 2017 of 25% |
(22,016 | ) | 44,032 | 22,016 | ||||||||
EFFECTS OF: |
||||||||||||
Different tax rates in subsidiaries |
101,087 | (151,909 | ) | (50,822 | ) | |||||||
Expenditure not deductible for tax purposes |
1,599 | (3,198 | ) | (1,599 | ) | |||||||
Expenses directly recognised in equity |
25,790 | (51,580 | ) | (25,790 | ) | |||||||
Additional deduction for R&D expenditure |
(195,195 | ) | 390,390 | 195,195 | ||||||||
Surrender of tax losses for repayable R&D credits |
85,210 | (170,420 | ) | (85,210 | ) | |||||||
Change in deferred tax assets not recognised |
195,083 | (195,083 | ) | | ||||||||
Utilisation of brought forward tax losses |
| 195,083 | 195,083 | |||||||||
Other effects |
19,251 | (28,131 | ) | (8,880 | ) | |||||||
|
|
|
|
|
|
|||||||
Tax credit for the current year |
210,809 | 29,184 | 239,993 | |||||||||
Tax related to previous period |
14,592 | (29,184 | ) | (14,592 | ) | |||||||
|
|
|
|
|
|
|||||||
Total tax credit |
225,401 | | 225,401 | |||||||||
|
|
|
|
|
|
F-135
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
5. Revenue
The group derives revenue from the transfer of goods and services in the following categories.
UK revenue was generated from intellectual property licenses granted (which includes milestone income as well as licensing income) and provision of R&D services on a fully loaded full-time equivalent (FTE) basis.
Revenue generated in the United States related to the receipt of a percentage of the proceeds due on sale of a related party entity, Denali BBB Holding Limited (formerly F-star Gamma Limited) and the option to nominate targets for drug development under intellectual property license agreements.
YEAR ENDED DECEMBER 31, 2017 |
Licensing
|
Milestone
|
Provision of
|
Total |
||||||||||||
Revenue from related parties in the UK |
2,310,131 | 1,141,320 | 12,297,964 | 15,749,415 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
2,310,131 | 1,141,320 | 12,297,964 | 15,749,415 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Timing of recognition: |
||||||||||||||||
At a point in time |
| 1,141,320 | | 1,141,320 | ||||||||||||
Over time |
2,310,131 | | 12,297,964 | 14,608,095 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
2,310,131 | 1,141,320 | 12,297,964 | 15,749,415 | ||||||||||||
|
|
|
|
|
|
|
|
F-136
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
^ |
See note 2.4ii for details of a change in accounting policy. |
All revenue in the year ended December 31, 2017, was generated from intellectual property licenses granted (milestone income and licensing income) and provision of R&D services on a fully loaded FTE basis.
Collaboration with Denali Therapeutics Inc.
In August 2016, F-star Biotechnology Limited, F-star Gamma Limited (a related party until May 30, 2018) (F-star Gamma), and F-star GmbH entered into a license and collaboration agreement (the Denali License and Collaboration Agreement) with Denali Therapeutics Inc.(Denali). The goal of the collaboration was the development of certain constant Fc domains of an antibody with non-native antigen binding activity (Fcabs), to enhance delivery of therapeutics across the blood brain barrier into the brain. The collaboration was designed to leverage F-stars modular antibody technology and Denalis expertise in the development of therapies for neurodegenerative diseases. In connection with the entry into the collaboration agreement, Denali also purchased from the F-star Gamma shareholders an option, which F-star refers to as the buy-out-option, to acquire all of the outstanding shares of F-star Gamma pursuant to a pre-negotiated share purchase agreement.
On May 30, 2018, Denali exercised such buy-out option and entered into a share purchase agreement, or the Purchase Agreement, with the shareholders of F-star Gamma and Shareholder Representative Services LLC, pursuant to which Denali acquired all of the outstanding shares of F-star Gamma, or the Acquisition.
As a result of the Acquisition, F-star Gamma has become a wholly owned subsidiary of Denali and Denali changed the entitys name to Denali BBB Holding Limited. In addition, Denali became a direct licensee of certain of the groups intellectual property (by way of Denalis assumption of F-star Gammas license agreement with the group, or the F-star Gamma License). Denali made initial exercise payments to the group and the former shareholders of F-star Gamma under the Purchase Agreement and the F-star Gamma License in the aggregate, of 15.9 million ($18.0 million), less the net liabilities of F-star Gamma, which were approximately 0.2 million ($0.2 million). Of this total, 3.5 million ($4.0 million) was payable to the group. In addition, Denali is required to make future contingent payments, to the group and the former shareholders of F-star Gamma, up to a maximum amount of 337.0 million ($437.0 million) in the aggregate upon the achievement of certain defined preclinical, clinical, regulatory and commercial milestones. Of this total, up to a maximum amount of 73.5 million ($91.4 million) is payable to the group. The total amount of the contingent payments varies based on whether F-star delivers an Fcab that meets pre-defined criteria and whether the Fcab has been identified solely by the group or solely by Denali or jointly by the group and Denali.
Under the terms of the Denali License and Collaboration Agreement, Denali has the right to nominate up to three Fcab targets for approval (Accepted Fcab Targets), within the first three years of the date of the Denali License and Collaboration Agreement. Upon entering into the Denali License and Collaboration Agreement, Denali had selected transferrin receptor, or TfR, as the first Accepted Fcab Target and paid an upfront fee of 4.9 million ($ 5.5 million) to F-star Gamma, which included selection of the first Accepted Fcab Target. In May 2018, Denali exercised its right to nominate two additional Fcab targets and identified a second Accepted Fcab Target. Denali made a one-time payment to the group for the two additional Accepted Fcab Targets of, in the aggregate, 5.2 million ($ 6.0 million) and has extended the time period for its selection of the third Accepted Fcab Target until approximately the fourth anniversary of the date of the Denali License and Collaboration Agreement.
Denali is also responsible for certain research costs incurred by F-star in conducting activities under each agreed development plan, for up to 24 months.
Under the terms of the Denali License and Collaboration Agreement, the group is prohibited from developing, commercializing and manufacturing any antibody or other molecule that incorporates any Fcab directed to an Accepted Fcab Target, or any such Fcab as a standalone product, and from authorizing any third party to take any such action.
F-137
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Revenue recognition
The group has considered whether the following obligations are distinct:
|
Grant of intellectual property licenses |
|
Provision of R&D services for development of the Fcabs |
Management concluded that the grant of intellectual property rights is not distinct from the provision of R&D services, as the R&D services are expected to significantly modify the early stage intellectual property. As a result, the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for this contract.
The initial transaction price for first Accepted Fcab Target was deemed to be 4.4 million which was for the grant of intellectual property rights and for the second Accepted Fcab Target at 4.4 million consisting of 2.7 million for the grant of intellectual property rights and 1.8 million for R&D services.
During the period ended May 6, 2019 and year ended December 31, 2018, the group recognized 1.5 million and 4.9 million respectively, relating to Licensing and R&D services based on the cost-to-cost method for the first Accepted Fcab Target, the consideration for which included the share of proceeds from the sale of F-star Gamma, and 0.1million and 0.2 million respectively relating to Licensing and R&D services for second Accepted Fcab Target.
Revenue related to the initial upfront payment and R&D services provided was recognized over the estimated period to sequence delivery using the cost-to-cost method of measurement of progress to completion (see 4.5ii).
For the year ended December 31, 2017 the group recognized 1.1 million relating to R&D services in accordance with IAS 18. Upon transition to IFRS 15, the promises within the contracts were determined to not be distinct and therefore a transition adjustment of 3.2 million was recorded as a decrease to retained earnings as a result of the combined performance obligation.
Intellectual Property Licensing and Services Agreements with F-star Beta Limited
In February 2015, the group entered into a number of intellectual property licensing agreements with a related party, F-star Beta Limited. The licenses granted F-star Beta Limited exclusive intellectual property rights to develop, commercialize and sub-license products generated against accepted targets from the use of the groups proprietary technology.
In consideration for the grant of intellectual property rights to F-star Beta Limited, a proportion of any payments made to F-star Beta Limited under any sub-license granted to a third party is paid to the group. The group is also eligible to receive development and regulatory milestones of 8.9 million and 25.5 million respectively per target. A mid-single digit royalty is also payable to the group on net sales of any product.
In February 2015, the group entered into a number of support services agreements with F-star Beta Limited. Under the terms of the support services agreement the provision of R&D services is charged at a fixed full-time equivalent (FTE) rate, which is billed monthly as incurred.
Revenue Recognition
The group has considered whether the following obligations are distinct:
|
Grant of intellectual property rights |
|
Provision of R&D services |
Management assessed that the R&D services in the contract were not distinct from the transfer of intellectual property rights, and therefore together they constitute a single combined performance obligation because the R&D services are expected to significantly modify the early stage preclinical intellectual property.
F-138
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
The total transaction price was initially estimated to be 1.1 million, which relates to the variable consideration deemed to be highly probable at the inception of the agreement. All other variable consideration to be paid to the group upon reaching certain milestones have been excluded from the calculation as it is not highly probable that a significant reversal of cumulative revenue recognized will not occur in a subsequent reporting period.
For the year ended December 31, 2017, the group recognized 13.5 million relating to licensing fees and R&D services in accordance with IAS 18. Upon transition to IFRS 15, the promises within the contracts were determined to not be distinct and therefore a transition adjustment of 3.8 million was recorded as a decrease to retained earnings as a result of the combined performance obligation.
During the period ended May 6, 2019 and the year ended December 31, 2018, R&D services were provided and sub-licenses granted to third parties. The total transaction price estimate was increased to 43.2 million. 7.4 million in the period ended May 6, 2019 and 16.0 million in the year ended December 31, 2018 of this total transaction price was recognized, based on the cost-to-cost method.
a. Assets and liabilities related to contracts with customers
The group has recognized the following liabilities related to contracts with customers:
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Deferred revenue related to upfront licensing fee, milestone income and R&D services income |
6,257,849 | 9,838,221 | | |||||||||
|
|
|
|
|
|
b. Revenue recognized in relation to contract liabilities
Deferred revenue related to licensing income |
Period ended May 6, 2019 |
Year ended
|
Year ended
|
|||||||||
Contract liabilities as of January 1 |
9,838,221 | | | |||||||||
Adoption of new accounting standard (note 2.4ii) |
| 6,922,742 | | |||||||||
Additional amounts deferred in the period |
607,191 | 7,660,740 | | |||||||||
Revenue recognized in the period included in opening contract liability |
(4,187,563 | ) | (4,745,261 | ) | | |||||||
|
|
|
|
|
|
|||||||
Contract liabilities as of May 6 and December 31 |
6,257,849 | 9,838,221 | | |||||||||
|
|
|
|
|
|
Revenue recognized in the period not included in opening contract liability for the period ended May 6, 2019 is 4.9 million, and for the year ended December 31, 2018 is 16.3 million.
c. Unsatisfied performance obligations at the reporting date
The following table shows unsatisfied performance obligations resulting from long-term intellectual property licensing and R&D services contracts.
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Aggregate amount of the transaction price |
6,257,849 | 9,838,221 | | |||||||||
|
|
|
|
|
|
F-139
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
The timing of the recognition of the transaction price allocated to unsatisfied contracts is uncertain as this is at the discretion of the customer.
The group has not recognized any assets in relation to costs to fulfil any long-term contracts.
6. Other income
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Recharges |
51,998 | 505,032 | 224,235 | |||||||||
Foreign exchange gains |
539,223 | | 7,303 | |||||||||
|
|
|
|
|
|
|||||||
591,221 | 505,032 | 231,538 | ||||||||||
|
|
|
|
|
|
7. Employee expenses
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Salaries |
2,798,538 | 6,729,531 | 5,748,866 | |||||||||
Employee share option scheme |
30,314 | 57,096 | 132,222 | |||||||||
Social security costs |
283,322 | 781,373 | 641,602 | |||||||||
Expenses for pensions and similar benefits |
257,261 | 426,504 | 330,636 | |||||||||
|
|
|
|
|
|
|||||||
3,369,435 | 7,994,504 | 6,853,326 | ||||||||||
|
|
|
|
|
|
F-star Biotechnology Limited, Cambridge, U.K, is a member of a defined contribution scheme for the benefit of eligible employees. The assets of the scheme are administered by the trustees in funds independent from those of the member companies. The pension charge for the period ended May 6, 2019 was 257,261 and for the year ended December 31, 2018 amounted to 426,504 (2017: 330,636). There were no outstanding contributions the date of the consolidated statements of financial position in any period.
The monthly average number of employees during each period was as follows:
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Full-time staff |
104 | 99 | 79 | |||||||||
|
|
|
|
|
|
|||||||
104 | 99 | 79 | ||||||||||
|
|
|
|
|
|
Key management personnel consist of the Director, the supervisory board (see note 25), Chief Financial Officer, Chief Scientific Officer and Chief Business Officer. Total remuneration for key management personnel.
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Compensation |
390,213 | 1,412,053 | 1,194,307 | |||||||||
Compensation for loss of office |
| 330,301 | | |||||||||
Company pension contributions to money purchase pension schemes |
8,375 | 55,184 | 53,115 | |||||||||
Share-based payment charge |
6,519 | | | |||||||||
|
|
|
|
|
|
|||||||
405,107 | 1,797,538 | 1,247,422 | ||||||||||
|
|
|
|
|
|
F-140
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
8. (Loss)/profit from operations
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Operating profit/(loss) contains: |
||||||||||||
Profit/ (loss) on exchange differences |
539,223 | (237,752 | ) | (123,615 | ) | |||||||
R&D expenditure |
1,678,294 | 4,674,222 | 3,696,122 |
9. Finance income and costs
a. Finance income
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Interest income from related parties |
124,549 | 163,161 | 116,215 | |||||||||
Other interest income |
| 620 | | |||||||||
|
|
|
|
|
|
|||||||
124,549 | 163,781 | 116,215 | ||||||||||
|
|
|
|
|
|
Other interest income and foreign exchange gains relate to cash and cash equivalents.
b. Finance costs
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Interest expense related to borrowings from related parties |
98,288 | 223,377 | 196,591 | |||||||||
Lease interest |
10,233 | | | |||||||||
Other interest expense |
| | 207 | |||||||||
Loss on foreign exchange |
| | 4,467 | |||||||||
|
|
|
|
|
|
|||||||
108,521 | 223,377 | 201,265 | ||||||||||
|
|
|
|
|
|
10. Income tax (credit)/charge ,
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Corporate tax (charge)/ credit current period |
(49,384 | ) | 194,760 | 239,993 | ||||||||
Corporate tax prior periods |
| 394 | (14,592 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total credit |
(49,384 | ) | 195,154 | 225,401 | ||||||||
|
|
|
|
|
|
F-141
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
The expected tax charge for the period based on the average groups tax rate for the periods 2019, 2018 and 2017 of 25% and the reported tax charge for the period can be reconciled as shown below:
Period ended May 6, 2019 |
Year ended
|
Year ended
|
||||||||||
Profit/(loss) before tax |
1,415,271 | 1,315,015 | (88,063 | ) | ||||||||
Profit before tax multiplied by the prevailing rate of Austrian corporate tax for the periods 2019, 2018 and 2017 of 25% |
(353,818 | ) | (328,754 | ) | 22,016 | |||||||
EFFECTS OF: |
||||||||||||
Different tax rates in subsidiaries |
53,859 | (234,031 | ) | (50,822 | ) | |||||||
Expenditure not deductible for tax purposes |
(89,333 | ) | | (1,599 | ) | |||||||
Expenses directly recognized in equity |
(5,760 | ) | (12,658 | ) | (25,790 | ) | ||||||
Additional deduction for R&D expenditure |
209,622 | 378,528 | 195,195 | |||||||||
Surrender of tax losses for repayable R&D credit |
| (792,563 | ) | (85,210 | ) | |||||||
R&D tax credits |
| 511,089 | | |||||||||
Impact of change in accounting policy |
| (214,275 | ) | | ||||||||
Utilization of brought forward tax losses |
102,785 | 916,206 | 195,083 | |||||||||
Accelerated capital allowances |
3,551 | | | |||||||||
Other effects |
29,710 | (28,782 | ) | (8,880 | ) | |||||||
|
|
|
|
|
|
|||||||
Tax credit for the current year |
(49,384 | ) | 194,760 | 239,993 | ||||||||
Tax related to previous period |
| 394 | (14,592 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total tax credit |
(49,384 | ) | 195,154 | 225,401 | ||||||||
|
|
|
|
|
|
* |
See note 4.5 for revision of previously issued financial statements for correction of an immaterial error |
No deferred tax asset has been recognized due to the current uncertainty of future taxable profits. The asset will be recognized when sufficient taxable profits are generated to relieve the losses, depreciation and capital allowances equalize, and other temporary differences reverse.
The group did not recognize deferred tax assets in respect of losses amounting to 23.8 million at May 6, 2019 and 26.8 million at December 31, 2018 (2017: 29.6 million) that can be carried forward against future taxable income. The aggregate amount of deferred taxes not recognized is 5.2 million at May 6, 2019 and 6.0 million at December 31, 2018 (2017: 6.8 million).
F-142
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
11. Intangible assets
Software |
Patents |
Total |
||||||||||
Cost |
||||||||||||
Opening balance January 1, 2019 |
| 510,000 | 510,000 | |||||||||
|
|
|
|
|
|
|||||||
Balance at May 6, 2019 |
| 510,000 | 510,000 | |||||||||
|
|
|
|
|
|
|||||||
Accumulated amortization |
||||||||||||
Opening balance January 1, 2019 |
| 316,625 | 316,625 | |||||||||
Amortization charge |
| 8,925 | 8,925 | |||||||||
|
|
|
|
|
|
|||||||
Balance as of May 6, 2019 |
| 325,550 | 325,550 | |||||||||
|
|
|
|
|
|
|||||||
Carrying amount as of May 6, 2019 |
| 184,450 | 184,450 | |||||||||
|
|
|
|
|
|
Software |
Patents |
Total |
||||||||||
Cost |
||||||||||||
Opening balance January 1, 2018 |
5,104 | 510,000 | 515,104 | |||||||||
Disposals |
(5,104 | ) | | (5,104 | ) | |||||||
|
|
|
|
|
|
|||||||
Balance at December 31, 2018 |
| 510,000 | 510,000 | |||||||||
|
|
|
|
|
|
|||||||
Accumulated amortization |
||||||||||||
Opening balance January 1, 2018 |
5,104 | 291,125 | 296,229 | |||||||||
Disposals |
(5,104 | ) | | (5,104 | ) | |||||||
Amortization charge |
| 25,500 | 25,500 | |||||||||
|
|
|
|
|
|
|||||||
Balance as of December 31, 2018 |
| 316,625 | 316,625 | |||||||||
|
|
|
|
|
|
|||||||
Carrying amount as of December 31, 2018 |
| 193,375 | 193,375 | |||||||||
|
|
|
|
|
|
Software |
Patents |
Total |
||||||||||
Cost |
||||||||||||
Balance at January 1, 2017 and December 31, 2017 |
5,104 | 510,000 | 515,104 | |||||||||
|
|
|
|
|
|
|||||||
Accumulated amortization |
||||||||||||
Opening balance January 1, 2017 |
5,104 | 265,625 | 270,729 | |||||||||
Amortization charge |
| 25,500 | 25,500 | |||||||||
|
|
|
|
|
|
|||||||
Balance as of December 31, 2017 |
5,104 | 291,125 | 296,229 | |||||||||
|
|
|
|
|
|
|||||||
Carrying amount as of December 31, 2017 |
| 218,875 | 218,875 | |||||||||
|
|
|
|
|
|
None of the groups intangible assets have restricted title or are pledged as security. All intangible assets are attributable to research and development activities that take place in the United Kingdom.
F-143
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
12. Property, plant and equipment
Leasehold
|
Plant and
|
Office
|
Fixtures and
|
Right-of-use |
Total |
|||||||||||||||||||
Cost |
||||||||||||||||||||||||
Opening balance January 1, 2019 |
244,761 | 3,425,365 | 105,853 | 234,047 | 941,306 | 4,951,332 | ||||||||||||||||||
Currency translation |
14,735 | 206,201 | 6,372 | 14,089 | 57,649 | 299,046 | ||||||||||||||||||
Additions |
13,930 | | | | 44,925 | 58,855 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as of May 6, 2019 |
273,426 | 3,631,566 | 112,225 | 248,136 | 1,043,880 | 5,309,233 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Accumulated depreciation |
||||||||||||||||||||||||
Opening balance January 1, 2019 |
234,149 | 1,758,171 | 79,144 | 50,886 | | 2,122,350 | ||||||||||||||||||
Currency translation |
14,365 | 110,569 | 5,188 | 3,667 | 3,718 | 137,507 | ||||||||||||||||||
Depreciation |
12,284 | 215,992 | 19,372 | 27,569 | 169,792 | 445,009 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as at May 6, 2019 |
260,798 | 2,084,732 | 103,704 | 82,122 | 173,510 | 2,704,866 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Carrying amount as of May 6, 2019 |
12,628 | 1,546,834 | 8,521 | 166,014 | 870,370 | 2,604,367 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
All right-of-use assets are generated from the leasing of office buildings. None of the groups property, plant and equipment is encumbered as collateral (2018 and 2017: none).
As at May 6, 2019, and December 31, 2018 and 2017 all property, plant and equipment is located in the United Kingdom.
Leasehold
|
Plant and
|
Office
|
Fixtures and
|
Total |
||||||||||||||||
Cost |
||||||||||||||||||||
Opening balance January 1, 2018 |
178,977 | 3,172,770 | 148,637 | 12,504 | 3,512,888 | |||||||||||||||
Currency translation |
(3,827 | ) | (52,392 | ) | (1,529 | ) | (3,937 | ) | (61,685 | ) | ||||||||||
Additions |
77,796 | 468,856 | | 225,480 | 772,132 | |||||||||||||||
Disposals |
(8,185 | ) | (163,869 | ) | (41,255 | ) | | (213,309 | ) | |||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2018 |
244,761 | 3,425,365 | 105,853 | 234,047 | 4,010,026 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Accumulated depreciation |
||||||||||||||||||||
Opening balance January 1, 2018 |
109,790 | 1,355,628 | 90,210 | 7,539 | 1,563,167 | |||||||||||||||
Currency translation |
(3,768 | ) | (27,370 | ) | (1,180 | ) | (849 | ) | (33,167 | ) | ||||||||||
Depreciation |
136,312 | 583,376 | 31,369 | 44,196 | 795,253 | |||||||||||||||
Disposals |
(8,185 | ) | (153,463 | ) | (41,255 | ) | | (202,903 | ) | |||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as at December 31, 2018 |
234,149 | 1,758,171 | 79,144 | 50,886 | 2,122,350 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Carrying amount as of December 31, 2018 |
10,612 | 1,667,194 | 26,709 | 183,161 | 1,887,676 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
F-144
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Leasehold
|
Plant &
|
Office
|
Fixtures &
|
Total |
||||||||||||||||
Cost |
||||||||||||||||||||
Opening balance January 1, 2017 |
172,077 | 2,338,865 | 139,635 | 13,350 | 2,663,927 | |||||||||||||||
Currency translation |
(6,397 | ) | (97,152 | ) | (9,455 | ) | (846 | ) | (113,850 | ) | ||||||||||
Additions |
13,297 | 931,057 | 18,457 | | 962,811 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2017 |
178,977 | 3,172,770 | 148,637 | 12,504 | 3,512,888 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Accumulated depreciation |
||||||||||||||||||||
Opening balance January 1, 2017 |
58,571 | 949,345 | 68,535 | 3,637 | 1,080,088 | |||||||||||||||
Currency translation |
(2,853 | ) | (40,369 | ) | (7,315 | ) | (267 | ) | (50,804 | ) | ||||||||||
Depreciation |
54,072 | 446,652 | 28,990 | 4,169 | 533,883 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2017 |
109,790 | 1,355,628 | 90,210 | 7,539 | 1,563,167 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Carrying amount as of December 31, 2017 |
69,187 | 1,817,142 | 58,427 | 4,965 | 1,949,721 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
13. Financial assets at fair value through profit or loss
The group has not elected to recognize fair value gains and losses through other comprehensive income for the following equity investments:
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Unlisted participation rights |
50,000 | 50,000 | 100,000 | |||||||||
|
|
|
|
|
|
|||||||
Total |
50,000 | 50,000 | 100,000 | |||||||||
|
|
|
|
|
|
FVPL financial assets are denominated in euros. These assets are comprised of investments in two start-up companies in the medical research business S-TARget Therapeutics GmbH and OncoQR ML GmbH which are located in Vienna, Austria. . As the products being developed by the entities are at an early stage of development, the research results are not predictable.
S-TARget Therapeutics GmbH concluded a license deal with a pharma company in 2014 for the development of therapeutic allergy vaccines. S-TARget sublicensed part of its Intellectual Property to OncoQR ML GmbH in 2017 and management are actively seeking partnering or sub-licensing deals.
Amounts recognized in profit and loss
During the period ended May 6, 2019 nil (December 31, 2018: a loss of 50,000 and 2017: nil) was recognized in the consolidated statements of comprehensive income within other expenses.
14. Trade and other receivables
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
DUE WITHIN ONE YEAR |
||||||||||||
Prepayments |
1,048,720 | 863,965 | 639,518 | |||||||||
Loans to related parties |
11,820,314 | 11,165,004 | 4,438,735 | |||||||||
Trade receivables from related parties |
1,532,977 | 1,336,933 | 1,097,401 | |||||||||
Other receivables |
1,344,363 | 490,268 | 1,308,023 | |||||||||
|
|
|
|
|
|
|||||||
Total |
15,746,374 | 13,856,170 | 7,483,677 | |||||||||
|
|
|
|
|
|
Amounts due from related parties are amounts due for R&D services performed and payments due under intellectual property licensing agreements. They are due for settlement within 30 days and therefore are all
F-145
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
classed as current. Amounts due from related parties are recognized initially at the amount of consideration that is unconditional, as they do not contain any significant financing components. The group holds the amounts due from related parties with the intention to collect the contractual cash flows and therefore measures them subsequently at amortized cost using the effective interest method. The maximum exposure to credit risk at the reporting date is the carrying value of each class of receivables above. The group does not hold any collateral as security.
The loan due from F-star Beta Ltd, a related party, is repayable on demand. Interest is settled quarterly in arrears at a rate of LIBOR plus 2%.
The carrying amounts of the groups trade and other payables are denominated in pounds sterling. For further information on loans to related parties, see note 24.
15. Cash and cash equivalents
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Cash and bank balances |
848,854 | 2,052,922 | 3,133,482 | |||||||||
|
|
|
|
|
|
|||||||
Total |
848,854 | 2,052,922 | 3,133,482 | |||||||||
|
|
|
|
|
|
16. Borrowings
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Borrowings from related parties |
9,056,202 | 7,464,111 | 7,573,318 | |||||||||
|
|
|
|
|
|
|||||||
Total |
9,056,202 | 7,464,111 | 7,573,318 | |||||||||
|
|
|
|
|
|
Borrowings from related parties contain short-term loans granted by F-star Alpha Limited amounting to £7.7 million (2018 and 2017: £6.7 million) that are subject to an interest of LIBOR plus 2% (see note 24).
For information about the groups exposure to interest rate and currency risks, refer to note 3 concerning financial risk management, for fair values of the liabilities at the date of the consolidated statements of financial position, please refer to note 20.
17. Trade and other payables
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Due within one year |
||||||||||||
Trade payables and other payables |
1,139,884 | 788,349 | 1,198,578 | |||||||||
Accruals |
2,221,023 | 1,242,961 | 492,095 | |||||||||
Tax and social security costs |
671,515 | 487,593 | 383,824 | |||||||||
|
|
|
|
|
|
|||||||
Total |
4,032,422 | 2,518,903 | 2,074,497 | |||||||||
|
|
|
|
|
|
Trade payables principally comprise amounts outstanding for trade purchases and ongoing costs. Accruals contain payables due to employees for outstanding bonus and other accruals.
F-146
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
18. Leases
All of the groups finance lease liabilities arise from the leasing of office buildings. These were accounted for as operating leases in prior years. See note 12 for the associated right-of-use assets.
May 6,
|
||||
Maturity analysis contractual undiscounted cash flows |
||||
Less than one year |
563,098 | |||
One to two years |
422,323 | |||
|
|
|||
Total undiscounted lease liability as at May 6, 2019 |
985,421 | |||
|
|
May 6,
|
||||
Lease liabilities included in the consolidated statements of financial position |
||||
Current |
528,006 | |||
Non-current |
413,657 | |||
|
|
|||
941,663 | ||||
|
|
May 6,
|
||||
Amounts recognized in the consolidated statements of comprehensive income |
||||
Finance cost - Interest on lease liabilities |
10,233 | |||
Other expenses - Expenses related to short-term leases (including low value and short-term leases) |
120,940 | |||
|
|
|||
131,173 | ||||
|
|
May 6,
|
||||
Amounts recognized in the consolidated statements of cash flows |
||||
Lease interest paid |
10,233 | |||
Principal elements of lease payments |
171,473 | |||
|
|
|||
181,706 | ||||
|
|
At December 31, 2018, the group had total minimum commitments under non-cancellable operating lease rentals expiring as follows:
2018 EUR |
2017 EUR |
|||||||
Within one year |
557,321 | 783,902 | ||||||
Later than one year and not later than five years |
553,255 | 283,356 | ||||||
|
|
|
|
|||||
Total |
1,110,576 | 1,067,258 | ||||||
|
|
|
|
The lease expenditure charged to the statement of comprehensive income during the year was EUR 795,701 (2017: EUR 815,470).
19. Capital management
The groups objectives when managing capital are to safeguard the groups ability to continue as a going concern. As the business of the group requires long-term financing of its R&D the future benefits of which are uncertain, the groups ability to raise long-term funding is a key factor, which determines the success of the group.
F-147
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Capital is raised through the increase of registered capital (either from existing shareholders or new investors), through shareholders equity contributions or through subordinated shareholder loans.
Registered capital is fully paid in; shares in the registered capital do not have a par value.
Capital reserves result from capital provided by shareholders of F-star GmbH. Transaction costs accounted for as a deduction from capital reserves amount to 187,694 at May 6, 2019 and December 31, 2018 (2017: 187,694). Consolidated financial statements of F-star GmbH as of May 6, 2019 and December 31, 2018 and 2017 are subject to approval by the shareholders meeting.
Foreign exchange reserves contain foreign exchange differences resulting from consolidation procedures.
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Share capital |
604,694 | 604,694 | 604,694 | |||||||||
Capital reserves |
28,599,822 | 28,599,822 | 28,599,822 | |||||||||
Share-based payment |
3,171,248 | 3,140,934 | 3,083,838 | |||||||||
Accumulated losses and foreign exchange reserve |
(32,944,847 | ) | (33,822,016 | ) | (28,386,622 | ) | ||||||
|
|
|
|
|
|
|||||||
Capital managed |
(569,083 | ) | (1,476,566 | ) | 3,901,732 | |||||||
|
|
|
|
|
|
20. Financial instruments
Measurement Categories
The group has classified its financial assets and liabilities into the following measurement groups with the fair values as stated in the table below:
F-148
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
21. |
Post-employment benefit obligations |
F-star Biotechnology Limited, Cambridge, is a member of a defined contribution scheme for the benefit of eligible employees. The assets of the scheme are administered by the trustees in funds independent from those of the member companies. The pension charge represents amounts payable by the group and amounted to 257,261 for the period ended May 6, 2019 and 426,504 for the year ended December 31, 2018 (2017: 330,636). Contributions of nil (2018 and 2017: nil) were outstanding as of the date of the consolidated statements of financial position.
22. |
Share based payments |
Employees of the group are included in the Enterprise Management Incentive scheme (EMI) of F-star GmbH, which commenced as an employee share option plan (ESOP) on 6 September 2007. Options were granted with no exercise price. The options have a contractual option term of 10 years from the date of grant. During the year ended December 31, 2017, the ESOP scheme was transferred to the EMI registered scheme, with all conditions remaining the same. The group did not adjust the charge recognized in the consolidated statements of comprehensive income in previous years under the ESOP scheme during the current period. As of the period ended May 6, 2019 and years ended December 31, 2018 and 2017, seventy-seven employees are currently eligible to participate in the share-based payment scheme. There are no reload features. Options granted under the EMI scheme, or previously the ESOP scheme, vest over a period of four years from the date of grant, but are only exercisable upon an exit. No performance conditions were included in the fair value calculations. All share-based payments are equity-settled.
The fair value of options granted was determined using the Black-Scholes model.15,117.4 options were granted in the period ended May 6, 2019 and no options were granted in the year ended December 31, 2018 (2017: nil). The fair value per option granted and the assumptions used in the calculation in the periods where options were granted are as follows:
Granted
in period ended May 6, 2019 |
Granted
in previous years |
|||||||
Exercise price |
| 10.00 | | nil | ||||
Share price at date of grant |
| 3.38 | | 60.00 | ||||
Vesting period (years) |
4 | 4 | ||||||
Expected volatility |
70.0 | % | 55 | % | ||||
Expected exit date |
06/14/2024 | 12/31/2017 | ||||||
Expected life in years |
5.1 | 2.4 | ||||||
Risk-free rate |
1.85 | % | 0.25 | % | ||||
Expected dividends expressed as a dividend yield |
0 | % | 0 | % | ||||
Fair value per option |
| 1.19 | | 30.00 |
F-149
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
The expected volatility is based on the estimate of the standard deviation of share prices in the same biotechnology sector. The expected life is the average expected period to exercise. The determination of the appropriate risk-free rate is based upon U.K. government gilts. A reconciliation of option movements is shown below:
2019
Number |
2019
Weighted average exercise price |
|||||||
Outstanding at January 1 |
101,417.1 | | ||||||
Granted in the period |
15,117.4 | | 10.00 | |||||
Forfeited in the period |
| | ||||||
|
|
|
|
|||||
Outstanding at May 6 |
116,534.5 | | 0.77 | |||||
|
|
|
|
|||||
Exercisable at May 6 |
| | ||||||
|
|
|
|
2018
Number |
2018
Weighted average exercise price |
|||||||
Outstanding at January 1 |
101,423.1 | | ||||||
Forfeited in the period |
(6.0 | ) | | |||||
|
|
|
|
|||||
Outstanding at December 31 |
101,417.1 | | ||||||
|
|
|
|
|||||
Exercisable at December 31 |
| | ||||||
|
|
|
|
2017
Number |
2017
Weighted average exercise price |
|||||||
Outstanding at January 1 |
103,098.9 | | ||||||
Forfeited in the period |
(1,675.8 | ) | | |||||
|
|
|
|
|||||
Outstanding at December 31 |
101,423.1 | | ||||||
|
|
|
|
|||||
Exercisable at December 31 |
| | ||||||
|
|
|
|
No share options were exercised during the period ended May 6, 2019 or the years ended December 31, 2018 and 2017. The total charge relating to employee share-based payment plans for the period ended May 6, 2019 was 30,314, and for the year ended December 31, 2018 57,096 (2017 132,222).
23. |
Commitments |
As of May 6, 2019, and December 31, 2018 and 2017, the group has no significant capital expenditure contracted for, but not recognized as a liability.
24. |
Related party transactions |
24.1 |
Owners |
During the period ended May 6, 2019 and the years ended December 31, 2018 and 2017, no shareholder of the group had a controlling interest, thus F-star GmbH represented the ultimate controlling party (see note 27 for change in ultimate controlling party subsequent to the period ended May 6, 2019). Some of the shareholders have special rights to determine the members of the supervisory board and, therefore, exercise significant influence on the financial and operating policy decisions. There were no transactions with shareholders with significant influence in the period ended May 6, 2019 or years ended December 31, 2018 and 2017.
F-150
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
24.2 |
Key management personnel |
Transactions with key management (all remuneration-related) are stated in note 7.
24.3 |
F-star Alpha Limited |
During the period ended May 6, 2019 and years ended December 31, 2018 and 2017, directors of F-star Alpha Limited (other than Eliot Forster, John Haurum and Tolga Hassan) were also members of the supervisory board of F-star GmbH. During the year ended December 31, 2016, F-star Biotechnology Limited borrowed from F-star Alpha Limited £4.7 million. A further £2.0 million was borrowed in February 2017, resulting in a balance owing (including interest) of £6.7 million (7.6 million) at December 31, 2017. In February 2019, an additional £1.0 million was loaned. A further £2.0 million was loaned after May 6, 2019 on May 8, 2019. The amounts loaned are repayable on demand. The loan agreement is subject to a maximum loan value of £12.0 million. Interest is settled quarterly in arrears at a rate of LIBOR plus 2%.
Transactions of F-star Biotechnology Limited with F-star Alpha Limited together with the balance outstanding at May 6, 2019, December 31, 2018 and December 31, 2017 were as follows:
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Income and recharges |
| 127,654 | 1,008,826 | |||||||||
Receivable balance outstanding |
| 125,498 | 3,251 | |||||||||
Interest expense |
(98,288 | ) | (223,435 | ) | (196,591 | ) | ||||||
Loan balance outstanding |
(9,056,202 | ) | (7,464,111 | ) | 7,573,318 |
During the period ended May 6, 2019 F-star GmbH invoiced F-star Alpha Limited 4,014 and for the year ended December 31, 2018 19,919 (2017: 20,913) for board costs with a balance outstanding of nil as of May 6, 2019 and 3,748 as of December 31, 2018 (2017: 3,576).
24.4 |
F-star Beta Limited |
During the period ended May 6, 2019 and the years ended December 31, 2018 and 2017 directors of F-star Beta Limited (other than E Forster, John Haurum and T Hassan) were also members of the supervisory board of F-star GmbH. In 2015, F-star Biotechnology Limited and F-star Beta Limited entered into an Intellectual Property License Agreement and a Support Services Agreement whereby F-star Beta Limited licensed Intellectual Property from F-star Biotechnology Limited, and F-star Biotechnology Limited agreed to provide Support Services to F-star Beta Limited.
R&D recharges related to research services are based on time incurred and include employment related costs charged on a FTE basis and non-employment related costs associated with the research activities.
On June 1, 2017, F-star Biotechnology Limited granted F-star Beta Limited a loan of £1.2 million. F-star Biotechnology Limited granted a second loan in the amount of £4.8 million in 2017, and £2.0 million of the prior loan amounts were repaid. F-star Biotechnology Limited granted a third loan in the amount of £1.1 million which was loaned in April 2018 and £5.0 million of the prior loan amounts were repaid in December 2018. The outstanding loan balance at December 31, 2018 was 11.2 million. The loan agreement is subject to a maximum loan value of £15 million. Interest is settled quarterly in arrears at a rate of LIBOR plus 2%.
F-151
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Transactions of F-star Biotechnology Limited in the period ended May 6, 2019 and the years ended December 31, 2018 and 2017 with F-star Beta Limited together with the balance outstanding at May 6, 2019, December 31, 2018 and December 31, 2017 were as follows:
May 6, 2019
|
December 31,
2018 |
December 31,
2017 |
||||||||||
Income and recharges |
7,904,295 | 16,018,289 | 13,282,545 | |||||||||
Interest income |
124,549 | 163,204 | 116,215 | |||||||||
Balance outstanding |
13,313,490 | 12,111,852 | 5,408,560 |
During the period ended May 6, 2019 F-star GmbH invoiced F-star Beta Limited 32,022 and in the year ended December 31, 2018, 169,687 (2017: 125,406) for board costs with a balance outstanding as of May 6, 2019 of nil and December 31, 2018 of 33,729 (December 31, 2017: 28,607).
24.5 |
Denali BBB Holdings Limited (formerly F-star Gamma Limited) |
Denali BBB Holdings Limited (formerly F-star Gamma Limited) was a related party by reason of the existence of common directors between the two entities until a transaction on May 30, 2018, which resulted in a change of control. Since May 30, 2018, management has no longer considered the entity to be a related party. During the period January 1, 2018 to May 30, 2018 F-star Biotechnology Limited charged Denali BBB Holdings Limited (formerly F-star Gamma Limited) 2.3 million for intellectual property licensing and R&D services (year ended December 31, 2017: 1.1 million). The amount receivable at year end was nil (2017: 58,662).
24.6 |
F-star Delta Limited |
During the period ended May 6, 2019 and the years ended December 31, 2018 and 2017, the directors of F-star Delta Limited (other than Eliot Forster, John Haurum and Tolga Hassan) were also members of the supervisory board of F-star GmbH. During the year ended December 31, 2017, the group entered into a support services agreement whereby the group agreed to provide R&D and support services to F-star Delta Limited.
Transactions of F-star Biotechnology Limited in the period ended May 6, 2019 and the years ended December 31, 2018 and 2017 with F-star Delta Limited together with the balance outstanding at May 6 2019, December 31, 2018 and December 31, 2017 were as follows:
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Income and recharges |
237,271 | 678,965 | 1,235,323 | |||||||||
Balance outstanding |
39,801 | 208,373 | 60,668 |
During the period ended May 6, 2019 F-star GmbH invoiced F-star Delta Limited 16,056, and the year ended December 31, 2018, 93,024 (2017: 49,039) for board costs with a balance outstanding as of December 31, 2018 of 18,739 (2017: 21,455).
None of the above transactions are subject to any guarantees or security and will be settled in cash. There are no further related-party transactions.
24.7 |
F-star Therapeutics Limited |
During the period ended May 6, 2019 and the from the date of incorporation, August 22, 2018 to December 31, 2018, one director of F-star Biotechnology Limited was the sole shareholder of F-star Therapeutics Limited. On May 7, 2019 F-star Therapeutics Limited became the ultimate controlling party of the group (see note 27).
F-152
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Transactions of F-star Biotechnology Limited in the periods ended May 6, 2019 and December 31, 2018 with F-star Therapeutics Limited together with the balance outstanding at May 6, 2019 and December 31, 2018 were as follows:
May 6,
2019 |
December 31,
2018 |
|||||||
Recharges |
698,218 | | ||||||
Balance included within other debtors |
698,218 | |
25. |
Corporate governance |
The director of the group, who was in office during the period ended May 6, 2019 and the years ended December 31, 2018 and 2017, was:
Eliot Forster (appointed effective October 1, 2018)
John Haurum (resigned effective October 1, 2018)
The members of the supervisory board of the group, who were in office during the during the period ended May 6, 2019 and the years ended December 31, 2018 and 2017, were:
John B. Edwards
Deborah Harland
Florian Rüker
Jean-François Formela
Patrick Krol
Helmut Schühsler
Nessan Bermingham (appointed April 1, 2018)
26. |
Earnings per share |
The calculation of basic and diluted earnings per share is based on the following data:
Period ended
May 6, 2019 |
Year ended
December 31, 2018 |
Year ended
December 31, 2017 |
||||||||||
Earnings |
||||||||||||
Earnings for the purposes of basic and diluted earnings per share |
213,364 | 235,902 | 21,453 | |||||||||
|
|
|
|
|
|
|||||||
Period ended May 6, 2019 |
Year ended
2018 |
Year ended
2017 |
||||||||||
Number of shares |
||||||||||||
Weighted average number of ordinary shares for the purposes of basic earnings per share |
94,459 | 94,459 | 94,459 | |||||||||
Effect of share options |
4,883 | | | |||||||||
Weighted average number of ordinary shares for the purposes of diluted earnings per share |
99,342 | 94,459 | 94,459 | |||||||||
Basic earnings per share |
2.26 | 2.500 | 0.23 | |||||||||
Diluted earnings per share |
2.15 | 2.500 | 0.23 |
27. |
Subsequent events |
Until May 7, 2019, there was no overall or ultimate controlling party of the group. On May 7, 2019, F-star GmbH was acquired by F-star Therapeutics Limited, a company incorporated in the United Kingdom. Shares in F-star
F-153
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H.
Therapeutics Limited were issued to the shareholders in consideration for 100% of the issued share capital of F-star GmbH. From May 7, 2019, F-star Therapeutics Limited is considered to be the immediate and ultimate controlling party.
The group borrowed £1.0 million in February 2019, £2.0 million in May 2019, and a further £0.5 million in September 2019, from a related party, F-star Alpha Limited. The borrowing agreement is subject to a maximum borrowing value of £12 million. Interest is settled quarterly in arrears at a rate of LIBOR plus 2%.
On August 29, 2019, the group entered into a loan agreement with F-star Delta Limited, a related party. The loan agreement is subject to a maximum loan value of £5.0 million and interest is settled quarterly in arrears at a rate of LIBOR plus 2%. £2.0 million was loaned to the F-star GmbH group by F-star Delta Limited on September 13, 2019 under this new loan agreement.
None of the events above have an impact on the May 6, 2019 financial statements.
On March 11, 2020 the World Health Organization declared the novel strain of coronavirus (COVID-19) a global pandemic and recommended containment and mitigation measures worldwide. It is likely that the outbreak will impact the group operations, but at the date of the signing of the financial statements management cannot reasonably estimate the length or severity of the pandemic or the extent to which the disruption may materially impact the business. Management took the decision in April 2020 to furlough a significant proportion of the R&D workforce and so project timelines may be delayed, which could impact the significant accounting estimates utilized in assessment of impairment of carrying value of investments in subsidiaries.
At this point it is not clear whether any project delays can be mitigated in the second half of 2020. Any adverse impact on operations, business or financial outlook could be material and management continues to closely monitor the situation.
On July 29, 2020, the ultimate parent entity F-star Therapeutics (F-star) entered into a share exchange agreement with Spring Bank Pharmaceuticals Inc (Spring Bank), a NASDAQ- listed, clinical-stage biopharmaceutical company. Pursuant to the share exchange agreement, Spring Bank will acquire the entire issued share capital of F-star in exchange for newly issued shares of Spring Bank common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the required approval of Spring Bank stockholders.
Spring Bank shareholders will have the opportunity to obtain potential future value in the form of two Contingent Value Rights (CVR) associated with Spring Banks SB 11285 IV clinical program and a STING antagonist research and development program. Subject to the terms of the first CVR agreement for the STING agonist clinical program, if one or more strategic transactions are consummated for SB 11285 by the combined company during a period that is the longer of one and a half years following the closing of the combination or one year after the final database lock of the current SB 11285 IV Phase 1a/1b trial, those equity holders of Spring Bank will receive the greater of 25% of the net proceeds from such transactions or $1.00 per share (on a pre-reverse split basis), provided that the aggregate net proceeds are at least approximately $18.0 million. Subject to the terms of the second CVR agreement, if a potential development agreement is consummated and one or more strategic transactions are consummated for the STING antagonist research platform by the combined company during the seven (7)-year period following the closing of the combination, those equity holders of Spring Bank will receive 80% of the net proceeds from such transactions. If Spring Bank enters into a development agreement for the STING antagonist research platform in advance of the closing of the proposed combination, Spring Bank may include certain proceeds from such transaction in its net cash calculation.
F-154
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of F-star Beta Limited
Opinion on the Financial Statements
We have audited the accompanying statements of financial position of F-star Beta Limited (the Company) as of May 6, 2019, December 31, 2018 and 2017, and the related statements of comprehensive income, of changes in equity and of cash flows for the period ended May 6, 2019 and the years ended December 31, 2018 and 2017, including the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of May 6, 2019, December 31, 2018 and 2017, and the results of its operations and its cash flows for the period ended May 6, 2019 and the years ended December 31, 2018 and 2017 in conformity with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
Change in Accounting Principle
As discussed in Note 2.1 to the financial statements, the Company has changed the manner in which it accounts for classification of expenses in 2019 and the manner in which it accounts for revenues from contracts with customers in 2018 as discussed in Note 2.4.
Substantial Doubt About the Companys Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2.2 to the financial statements, the Company will require additional financing to fund its operating expenses and capital expenditure requirements which raises substantial doubt about its ability to continue as a going concern. Managements plans in regard to these matters are also described in Note 2.2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on the Companys financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
PricewaterhouseCoopers LLP
Cambridge, United Kingdom
August 28, 2020
We have served as the Companys auditor since 2015.
F-157
F-STAR BETA LIMITED
STATEMENTS OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED MAY 6, 2019 AND THE YEARS ENDED DECEMBER 31, 2018 AND 2017
Period ended May 6, 2019 |
Year ended December 31, 2018^ |
Year ended December 31, 2017^ |
||||||||||||
Note | £ | £ | £ | |||||||||||
Revenue |
5 | 7,902,856 | 17,394,263 | 14,993,243 | ||||||||||
Costs related to collaborative arrangements |
6 | (1,863,660 | ) | (6,719,286 | ) | (3,289,171 | ) | |||||||
Research & development costs |
(5,106,552 | ) | (12,048,753 | ) | (11,933,309 | ) | ||||||||
General & administrative expenses |
(908,791 | ) | (345,485 | ) | (352,053 | ) | ||||||||
Other gains |
7 | | 815 | 166,352 | ||||||||||
Other expenses |
(58,036 | ) | (20,212 | ) | | |||||||||
|
|
|
|
|
|
|||||||||
Loss on operations |
8 | (34,183 | ) | (1,738,658 | ) | (414,938 | ) | |||||||
Finance costs |
9 | (103,216 | ) | (144,677 | ) | (101,825 | ) | |||||||
|
|
|
|
|
|
|||||||||
Loss before tax from continuing operations |
(137,399 | ) | (1,883,335 | ) | (516,763 | ) | ||||||||
|
|
|
|
|
|
|||||||||
Corporation tax benefit |
11 | 639,359 | 2,415,968 | 705,465 | ||||||||||
|
|
|
|
|
|
|||||||||
Profit for the year and total comprehensive income attributable to equity holders of the parent |
501,960 | 532,633 | 188,702 | |||||||||||
|
|
|
|
|
|
|||||||||
Earnings per share for profit attributable to the shareholders of the Company |
||||||||||||||
Basic earnings per share |
21 | 0.05 | 0.06 | 0.02 | ||||||||||
Diluted earnings per share |
21 | 0.05 | 0.06 | 0.02 |
^Refer to note 2.1 for information regarding the classification of expenses for comparative periods
The accompanying notes form an integral part of these financial statements.
F-158
F-STAR BETA LIMITED
STATEMENTS OF FINANCIAL POSITION
AS OF THE PERIOD ENDED MAY 6, 2019 AND THE YEARS ENDED DECEMBER 31, 2018 AND 2017
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||||||
Note | £ | £ | £ | |||||||||||||
ASSETS |
||||||||||||||||
Non-current assets |
||||||||||||||||
Intangible assets, net |
12 | 533,949 | 483,949 | | ||||||||||||
Current assets |
||||||||||||||||
Trade and other receivables |
13 | 1,208,343 | 784,512 | 834,893 | ||||||||||||
Corporation tax receivable |
11 | 3,069,341 | 2,429,980 | 2,285,135 | ||||||||||||
Cash and cash equivalents |
14 | 915,436 | 5,709,474 | 1,909,973 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total current assets |
5,193,120 | 8,923,966 | 5,030,001 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total assets |
5,727,069 | 9,407,915 | 5,030,001 | |||||||||||||
|
|
|
|
|
|
|||||||||||
EQUITY AND LIABILITIES |
||||||||||||||||
Capital and reserves |
||||||||||||||||
Issued capital |
15 | 93 | 91 | 91 | ||||||||||||
Accumulated losses |
(7,976,643 | ) | (9,167,282 | ) | (391,138 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Total equity |
(7,976,550 | ) | (9,167,191 | ) | (391,047 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Current liabilities |
||||||||||||||||
Trade and other payables |
17 | 13,352,608 | 12,184,899 | 5,421,048 | ||||||||||||
Deferred revenue |
5 | 351,011 | 6,390,207 | | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total liabilities |
13,703,619 | 18,575,106 | 5,421,048 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Total equity and liabilities |
5,727,069 | 9,407,915 | 5,030,001 | |||||||||||||
|
|
|
|
|
|
The accompanying notes form an integral part of these financial statements.
F-159
F-STAR BETA LIMITED
STATEMENTS OF CHANGES IN EQUITY
FOR THE PERIOD ENDED MAY 6, 2019 AND THE YEARS ENDED DECEMBER 31, 2018 AND 2017
Issued
capital |
Accumulated
losses |
Total equity | ||||||||||||||
Note | £ | £ | £ | |||||||||||||
Balance as of January 1, 2017 |
91 | (708,026 | ) | (707,935 | ) | |||||||||||
Profit for the financial year and total comprehensive income |
| 188,702 | 188,702 | |||||||||||||
Transactions with owners of the Company, recognized directly in equity |
||||||||||||||||
Share-based payments |
18 | | 128,186 | 128,186 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2017 |
91 | (391,138 | ) | (391,047 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Change in accounting policy (note 2.4) |
| (9,340,724 | ) | (9,340,724 | ) | |||||||||||
Revised balance as of January 1, 2018 |
91 | (9,731,862 | ) | (9,731,771 | ) | |||||||||||
Profit for the financial year and total comprehensive income |
| 532,633 | 532,633 | |||||||||||||
Transactions with owners of the Company, recognized directly in equity |
||||||||||||||||
Share-based payments |
18 | | 31,947 | 31,947 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2018 |
91 | (9,167,282 | ) | (9,167,191 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Balance as of January 1, 2019 |
91 | (9,167,282 | ) | (9,167,191 | ) | |||||||||||
Profit for the financial period and total comprehensive income |
| 501,960 | 501,960 | |||||||||||||
Transactions with owners of the Company, recognized directly in equity |
||||||||||||||||
Issue of ordinary share capital |
2 | | 2 | |||||||||||||
Share-based payments |
18 | | 688,679 | 688,679 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Balance as of May 6, 2019 |
93 | (7,976,643 | ) | (7,976,550 | ) | |||||||||||
|
|
|
|
|
|
The accompanying notes form an integral part of these financial statements.
F-160
F-STAR BETA LIMITED
FOR THE PERIOD ENDED MAY 6, 2019 AND THE YEARS ENDED DECEMBER 31, 2018 AND 2017
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||||||
Note | £ | £ | £ | |||||||||||||
Cash flows from operating activities |
||||||||||||||||
Loss before tax |
(137,399 | ) | (1,883,335 | ) | (516,763 | ) | ||||||||||
Adjustments for: |
||||||||||||||||
Share-based payments charge |
18 | 688,679 | 31,947 | 128,186 | ||||||||||||
Finance costs |
9 | 103,216 | 144,677 | 101,825 | ||||||||||||
Loss on disposal on fixed asset |
| 933,536 | | |||||||||||||
Amortization |
| 44,096 | | |||||||||||||
(Increase)/decrease in trade and other receivables |
13 | (423,831 | ) | 50,381 | (285,455 | ) | ||||||||||
Increase in trade payables |
17 | 1,187,037 | 637,731 | 455,546 | ||||||||||||
Decrease in deferred income |
5 | (6,039,196 | ) | 6,390,207 | (2,841,850 | ) | ||||||||||
Adoption of new accounting standard |
2.4 | | (9,340,724 | ) | | |||||||||||
|
|
|
|
|
|
|||||||||||
Adjusted loss before tax |
(4,621,494 | ) | (2,991,484 | ) | (2,958,511 | ) | ||||||||||
Proceeds from sale of intangible assets |
| 962,000 | 984,691 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Cash used in operating activities |
(4,621,494 | ) | (2,029,484 | ) | (1,973,820 | ) | ||||||||||
Corporation tax received |
11 | | 2,271,123 | | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net cash used in operating activities |
(4,621,494 | ) | 241,639 | (1,973,820 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Cash used in investing activities |
||||||||||||||||
Payments to acquire intangible assets |
12 | (50,000 | ) | (2,423,581 | ) | (984,691 | ) | |||||||||
|
|
|
|
|
|
|||||||||||
Net cash used in investing activities |
(50,000 | ) | (2,423,581 | ) | (984,691 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Cash flows from financing activities |
||||||||||||||||
Proceeds of loan from related party |
19 | | 6,108,876 | 4,750,000 | ||||||||||||
Repayment of loan from related party |
19 | | | (2,000,000 | ) | |||||||||||
Interest paid |
(122,544 | ) | (127,433 | ) | (82,767 | ) | ||||||||||
Receipt for unpaid share capital |
| | 2 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Net cash (used in)/generated from financing activities |
(122,544 | ) | 5,981,443 | 2,667,235 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Net (decrease)/increase in cash and cash equivalents |
(4,794,038 | ) | 3,799,501 | (291,276 | ) | |||||||||||
Cash and cash equivalents as of beginning of year |
5,709,474 | 1,909,973 | 2,201,249 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Cash and cash equivalents as of end of period |
14 | 915,436 | 5,709,474 | 1,909,973 | ||||||||||||
|
|
|
|
|
|
F-161
F-STAR BETA LIMITED
STATEMENTS OF CASH FLOWS
FOR THE PERIOD ENDED MAY 6, 2019 AND THE YEARS ENDED DECEMBER 31, 2018 AND 2017
Reconciliation of movement in liabilities from financing activities |
Period
ended
2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
|||||||||
£ | £ | £ | ||||||||||
Beginning of period |
10,067,634 | 3,941,514 | 1,172,454 | |||||||||
Cash flows |
(122,544 | ) | 5,981,443 | 2,667,235 | ||||||||
Non-cash charges |
||||||||||||
Interest charged |
103,216 | 144,677 | 101,825 | |||||||||
|
|
|
|
|
|
|||||||
End of period |
10,048,306 | 10,067,634 | 3,941,514 | |||||||||
|
|
|
|
|
|
The accompanying notes form an integral part of these financial statements
F-162
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
1. |
General information |
F-star Beta Limited (the Company) is a private limited company incorporated under the laws of England and Wales. The Companys registered office is Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT. The Company is domiciled in the United Kingdom.
The Companys principal activities are the discovery and development of therapies intended to treat serious diseases with a focus on the development of bispecific antibodies for the treatment of immuno-oncology.
The financial statements were authorized by the Companys Board of Directors on August 28, 2020.
2. |
Summary of significant accounting policies |
The principal accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.
2.1 |
Basis of preparation |
These financial statements have been prepared on a going concern basis in accordance with International Financial Reporting Standards (IFRS) and interpretations issued by the IFRS Interpretations Committee (IFRS IC) as issued by the International Accounting Standards Board (IASB). The financial statements have been prepared under the historical cost convention.
Following a management review of the presentation of the statement of income for the current reporting period, it was determined that a by function presentation would provide more reliable and relevant information to the users of the financial statements. Therefore, for comparability of the data presented, for the years ended December 31, 2018 and 2017 the presentation of the statements of comprehensive income has been changed to a by function presentation, whereas the previous presentation was by nature. Due to this presentational change and the associated requirements of IAS 1 Presentation of financial statements, the company adopted a policy of classifying certain costs as costs related to collaborative arrangements (see note 2.17).
The following table illustrates the reclassification of costs from other expenses under the by nature presentational format to the revised expense categories under the by function presentational format the for the years ended December 31, 2018 and December 21, 2017:
Presentation by nature | Presentation by function | |||||||||||||||||||||||||||
Other
expenses £ |
Total
£ |
Costs related to
collaborative arrangements £ |
Research &
development costs £ |
General &
administrative expenses £ |
Other
expenses £ |
Total
£ |
||||||||||||||||||||||
Year ended December 31, 2018 |
19,133,736 | 19,133,736 | 6,719,286 | 12,048,753 | 345,485 | 20,212 | 19,133,736 | |||||||||||||||||||||
Year ended December 31, 2017 |
15,574,533 | 15,574,533 | 3,289,171 | 11,933,309 | 352,053 | | 15,574,533 |
Revision of intangible asset disclosures
The previously reported intangible asset disclosures for the years ended December 31, 2018 and 2017 have been revised in these financial statements for the correction of an error (see note 4.3).
F-163
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
2.2 |
Going concern |
As of August 28, 2020, the date of approval of the financial statements for the period ended May 6, 2019, the company does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about the companys ability to continue as a going concern.
F-star Therapeutics Limited expects to seek equity financing from existing and new investors in conjunction with the contemplated Share Exchange Agreement entered into on July 29, 2020 between F-star Therapeutics Limited and Spring Bank Pharmaceuticals Inc. The closing of the Share Exchange Agreement would provide access to the existing cash deposits of Spring Bank Pharmaceuticals Inc as well as expected additional equity financing to be raised by F-star Therapeutics Limited as part of the Exchange. The estimated closing is anticipated in Q4 2020. The closing of the Share Exchange Agreement is however subject to approval by the shareholders of Spring Bank Pharmaceuticals Inc. If the merger is unsuccessful, the parent undertaking will seek additional funding through equity financing from existing shareholders, or other alternative sources, which the directors believe can be obtained. Accordingly, the directors believe it is appropriate to continue to adopt the going concern basis of accounting. The financial statements do not include any adjustments that would be necessary if the group headed by F-star Therapeutics Limited and the company were unable to continue as a going concern.
F-star Therapeutics Limited, the parent undertaking has provided a letter of support to the group, committing to provide funding for operations for at least 12 months from the issuance date of these financial statements. As F-star Therapeutics Limited has insufficient cash to fund the groups operations for at least the next 12 months, the provision of this support is contingent upon successful fundraising.
2.3 |
Estimates and judgments |
In the application of the companys accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are relevant. Actual results may differ from these estimates. See note 4 for details of critical estimates and judgments.
2.4 |
New standards, amendments and IFRIC interpretations |
New standards, amendments and interpretations adopted by the company
i. IFRS 9 Financial Instruments
IFRS 9 Financial Instruments (IFRS 9) replaces the provisions of IAS 39 that relate to the recognition, classification and measurement of financial assets and financial liabilities, derecognition of financial instruments, impairment of financial assets and hedge accounting. IFRS 9 contains three principal classification categories for financial assets, measured as amortized cost, fair value through other comprehensive income and fair value through profit and loss. The classification of financial assets is generally based on the business model in which a financial asset is managed and its contractual cash flow characteristics.
F-164
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
On January 1, 2018 (the date of initial application of IFRS 9), the Companys management has assessed which
business models apply to the financial assets held by the Company and has classified its financial instruments into the appropriate IFRS 9 categories. The main effects resulting from this reclassification are as follows:
Note |
Original
classification under IAS 39 |
New
classification under IFRS 9 |
Original
carrying amount under IAS 39 £ |
New
carrying amount under IFRS 9 £ |
||||||||||||||||
Financial assets |
(a) | |||||||||||||||||||
Trade and other receivables |
|
Loans and
receivables |
|
Amortised cost | 813,245 | 813,245 | ||||||||||||||
Cash and cash equivalents |
|
Loans and
receivables |
|
Amortised cost | 1,909,973 | 1,909,973 | ||||||||||||||
|
|
|
|
|||||||||||||||||
Total financial assets |
2,723,218 | 2,723,218 | ||||||||||||||||||
|
|
|
|
|||||||||||||||||
Financial liabilities |
(b) | |||||||||||||||||||
Trade payables and accruals |
|
Other financial
liabilities |
|
Amortised cost | 616,813 | 616,813 | ||||||||||||||
Amounts due to related parties |
|
Other financial
liabilities |
|
Amortised cost | 4,804,235 | 4,804,235 | ||||||||||||||
|
|
|
|
|||||||||||||||||
Total financial liabilities |
5,421,048 | 5,421,048 | ||||||||||||||||||
|
|
|
|
(a) |
Trade and other receivables: Trade and other receivables that were classified as loans and receivables under IAS 39 are now classified as amortized cost. The Company applies the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss allowance for all trade receivables and contract assets. |
(b) |
Trade payables and accruals: IFRS 9 largely retains the existing requirements in IAS 39 for the classification and measurement of financial liabilities. |
IFRS 9 replaces the incurred loss model in IAS 39 with expected credit loss model. The new impairment model applies to financial assets measured at amortised cost, contract assets and debt investments at FVOCI, but not to investments in equity instruments. Under IFRS 9 credit losses are recognized earlier than under IAS 39.
For assets in the scope of the IFRS 9 impairment model the impairment losses are generally expected to increase and become more volatile. The Company has determined that any allowance for impairment due to the application of the IFRS 9 impairment requirements as of January 1, 2018 would be immaterial.
Full details of IFRS 9 effective from January 1, 2018 are included in note 2.8.
F-165
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
ii IFRS 15Revenue from Contracts with Customers
The Company has adopted IFRS 15 Revenue from Contracts with Customers on a modified retrospective basis from January 1, 2018. Under IAS 18, the license and R&D were two separate components because the commercial effect was separate. The Company assessed the license and R&D services under IFRS 15 criteria and concluded the R&D services were significantly modifying the license and as such resulted in a combined performance obligation. A cost-to-cost method to measure progress of completion of the performance obligations has been used to assess the revenue to be recognized at each reporting date. This has resulted in the following changes to the financial statements:
Statement of financial position (extract) |
IAS 18
December 31,
£ |
Remeasurement £ |
IFRS 15
January 1,
£ |
|||||||||
Current liabilitiesdeferred revenue |
| 9,340,724 | 9,340,724 |
The impact on the Companys accumulated losses as at January 1, 2018 is as follows:
Note | £ | |||||||
Balance as at December 31, 2017 as originally stated |
(391,138 | ) | ||||||
Change in accounting policy |
(9,340,724 | ) | ||||||
|
|
|
|
|||||
Total equity as at January 1, 2018 |
(9,731,862 | ) | ||||||
|
|
|
|
Under IAS 18, £14.4 million would have been recognized in the statement of comprehensive income for the year ended December 31, 2018.
The new accounting policies adopted by the Company at January 1, 2018 are included in section 2.16 of this note.
New standards, amendments and interpretations not yet adopted
A number of new standards and amendments to standards and interpretations are effective for annual periods beginning after January 1, 2019. None of these are expected to have a significant effect on the financial statements.
2.5 |
Foreign currency translation |
Foreign currency transactions are translated into pounds sterling, the companys functional currency, using the exchange rates prevailing at the date of the transactions or valuation where items are remeasured. Foreign exchange gains and losses resulting from the settlement of monetary assets and liabilities denominated in foreign currencies are recognized in the statement of comprehensive income. Foreign exchange gains and losses that relate to borrowings and cash and cash equivalents are presented in the statement of comprehensive income within finance income or costs. All other foreign exchange gains and losses are presented within other gains in the statement of comprehensive income.
2.6 |
Intangible assets |
Expenditure on research activities are recognized in the statement of comprehensive income as incurred. Development expenditure is capitalized only if the expenditure can be measured reliably, the product is technically and commercially feasible, future economic benefits are probable, and the company has sufficient resources to complete or sell the asset.
F-166
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
Acquired intangible assets, including intellectual property rights that have finite useful lives, are measured at cost less accumulated amortization and any accumulated impairment losses.
Subsequent expenditure is capitalized only when it increases the future economic benefits of the asset to which it relates. All other expenditure is recognized in the statements of comprehensive income as incurred.
Proceeds received on the disposal of intangible assets via exclusive intellectual property licensing arrangements are classified as revenue. On such a disposal, the capitalized cost relating to rights sold is charged to cost of sales. Amortization of intangible fixed assets are included within operating expenses in the statement of statement of comprehensive income.
Intangible assets are amortized over their estimated useful economic lives, using the straight-line method:
Intellectual Property Rights | Over the remaining life of the relevant patents (full life assumed to be 20 years). This results in a range of UELs between 20 and 7 years |
2.7 |
Impairment of non-financial assets |
At the date of the statement of financial position, the company reviews the carrying amounts of its long-lived assets to determine whether there is any indication that those assets have suffered an impairment loss.
For the purpose of measuring recoverable amounts, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units or CGUs). The recoverable amount is the higher of fair value less cost of disposal and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the estimates of future cash flows have not been adjusted.
If the recoverable amount of an asset is estimated to be less than its carrying amount, the carrying amount of the asset is reduced to its recoverable amount. An impairment loss is recognized as part of operating expenses immediately.
2.8 |
Financial instruments |
i. |
Financial assets |
The Company has adopted IFRS 9 effective January 1, 2018. Upon adoption the Company elected to take the transition relief as provided by IFRS 9, which permits an entity not to restate prior periods on initial application of the standard and any adjustments to be made to the opening retained earnings balance as of January 1, 2018. As a result, the 2017 comparative information provided continues to be accounted for in accordance with the Companys previous accounting policy.
Classification
All financial assets relate to cash and cash equivalents and trade and other receivables and until December 31, 2017 the Company stated all these assets at their recoverable amount, which approximated to fair value due to their short-term nature. From January 1, 2018 on initial recognition all financial assets within the Company are classified as measured at amortized cost, based upon the Companys business model for managing the financial assets and the contractual terms of the cash flows.
F-167
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
Recognition and derecognition
Financial assets are derecognized when the right to receive cash flows from the financial assets have expired or have been transferred and the Company has transferred substantially all the risks and rewards of ownership.
Measurement
At initial recognition, the Company measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss (FVPL), transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets carried at FVPL are expensed in the statements of comprehensive income.
Subsequent measurement of debt instruments depends on the Companys business model for managing the asset and the cash flow characteristics of the asset. As stated above, all financial assets in the Company are held at amortized cost.
Amortized cost
Assets that are held for collection of contractual cash flows where those cash flows represent solely payments of principal and interest are measured at amortized cost. Interest income from these financial assets is included in finance income using the effective interest rate method. Any gain or loss arising on derecognition is recognized directly in profit or loss and presented in other gains/(losses) together with foreign exchange gains and losses. Impairment losses are presented as separate line item in the statements of comprehensive income.
Impairment
From January 1, 2018 the Company assesses on a forward-looking basis the expected credit loss associated with its debt instruments carried at amortized cost. The impairment methodology applied depends on whether there has been a significant increase in credit risk. For trade receivables, the Company applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognized from initial recognition of the receivables.
All financial assets relate to cash and cash equivalents and trade and other receivables, which are stated at their recoverable amount, which approximates the fair value due to the short term nature of these assets.
ii. |
Financial liabilities |
Financial liabilities at amortized cost include trade payables and other payables excluding non-financial liabilities. Trade payables are initially recognized at the amount required to be paid. Subsequently, trade payables are measured at amortized cost, which approximates the fair value due to the short-term nature of these liabilities.
2.9 |
Offsetting financial instruments |
Financial assets and liabilities are reported at their net amount in the statements of financial position if there is a legally enforceable right of offset and there is an intention to settle. The legally enforceable right must not be contingent on future events and must be enforceable in the normal course of business and in the event of default, insolvency or bankruptcy of the company or the counterparty.
2.10 |
Trade and other receivables |
Financial assets included in trade and other receivables are recognized initially at fair value. The company holds these receivables with the objective to collect the contractual cash flows and therefore measures them
F-168
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
subsequently at amortized cost using the effective interest method, less any impairment losses. Prior to January 1, 2018 the Company provided an allowance for uncollectible accounts based on prior experience and managements assessment of the collectability of existing specific accounts. From January 1, 2018, the Company also assesses the expected credit losses associated with these financial assets on a forward-looking basis.
2.11 |
Cash and cash equivalents |
Cash and cash equivalents comprise cash on hand and demand deposits and other short-term and highly liquid investments that are readily convertible to a known amount of cash and are subject to an insignificant risk of changes in value with original maturities of three months or less.
2.12 Equity and reserves
Ordinary shares and preferred shares are classified as equity. The Companys issued capital represents the nominal value of shares that have been issued. Accumulated losses includes all current period retained profits and accumulated losses.
2.13 Trade and other payables
Trade and other payables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payable are classified as current liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities.
Deferred revenue
Payments for unsatisfied performance obligations to be completed in future periods are recorded in the statements of financial position as contract liabilities (deferred revenue).
2.14 |
Current and deferred income tax |
The tax credit/charge represents the sum of the tax currently receivable/payable and deferred tax. The tax currently payable/receivable is based on taxable profit/loss for the year. Taxable profit/loss differs from net profit/loss as reported in the statements of comprehensive income because it excludes items of income or expense that are taxable or deductible in other years and it further excludes items that are never taxable or deductible. The companys asset/liability for current tax is calculated using tax rates that have been enacted or substantively enacted by the date of the statements of financial position.
R&D expenditure is written off in the year in which it is incurred. Any tax credit receivable under the small company R&D scheme is recognized in Income tax in the statements of comprehensive income.
Deferred tax is the tax expected to be payable or recoverable on differences between the carrying amounts of assets and liabilities in the financial statements and the corresponding tax bases used in the computation of taxable profit and is accounted for using the balance sheet liability method. Deferred tax liabilities are generally recognized for all taxable temporary differences and deferred tax assets are recognized to the extent that it is probable that taxable profits will be available against which deductible temporary differences can be utilized. Such assets and liabilities are not recognized if the temporary difference arises from the initial recognition of goodwill or from the initial recognition (other than in a business combination) of other assets and liabilities in a transaction, which affects neither the taxable profit nor the accounting profit.
Deferred tax liabilities are recognized for taxable temporary differences arising on investments in subsidiaries except where the Company is able to control the reversal of the temporary difference and it is probable that the temporary difference will not reverse in the foreseeable future.
F-169
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
The carrying amount of deferred tax assets is reviewed as of the date of the statements of financial position and reduced to the extent that it is no longer probable that sufficient taxable profits will be available to allow all or part of the asset to be recovered.
Deferred tax is calculated at the tax rates that are expected to apply in the period when the liability is settled, or the asset is realized. Deferred tax is charged or credited in the statements of comprehensive income, except when it relates to items charged or credited directly to equity, in which case the deferred tax is also dealt with in equity.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to set off current tax assets against current tax liabilities and when they relate to income taxes levied by the same taxation authority and the company intends to settle its current tax assets and liabilities on a net basis.
2.15 |
Share-based payments |
The Company operates an equity-settled, share-based compensation plan, under which the Company receives services from employees of F-star Biotechnology Limited (F-star Biotech) as consideration for the issuance of Company equity instruments (options). The fair value of the services received in exchange for the grant of the options is recognized as an expense. The total amount to be expensed is determined by reference to the fair value of the options granted, excluding the impact of any service and non-market performance vesting conditions.
Non-market performance and service conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. As of the end of each reporting period, the Company revises its estimate of the number of options that are expected to vest based on the non-market vesting and service conditions. It recognizes the impact of the revision to original estimates, if any, in the statements of comprehensive income, with a corresponding adjustment to equity.
2.16 |
Revenue recognition |
The Companys revenues are generated through its intellectual property licensing and service arrangements with one external customer and the provision of intellectual property licenses and research and development (R&D) services to one related party. The terms of the arrangement with the external customer include the performance of R&D services, the grant of intellectual property rights and the option to acquire further intellectual property rights. In exchange for the initial grant of intellectual property rights and R&D services the Company received a non-refundable upfront license payment and will receive variable consideration in the form of milestone payments that are based on the achievement of defined collaboration objectives.
On inception of a new contract management identifies performance obligations and consider if these performance obligations are distinct. Performance obligations are promised services in a contract to transfer a distinct service to the customer. Promised services are considered distinct when: (i) the customer can benefit from the service on its own or together with other readily available resources, and (ii) the promised service is separately identifiable from other promises in the contract. In assessing whether promised services are distinct, management considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, management considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
For customer options to acquire intellectual property rights, management assesses if the optional future services are offered at the standalone selling price. If this is the case, then the option is not deemed to provide the
F-170
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
customer with a material right and is not considered to be a separate performance obligation. In determining the standalone selling price management consider factors such as identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until the option is exercised or expires, whichever is earliest.
Management estimates the transaction price based on the amount of consideration the Company expects to receive for transferring the promised services in the contract and allocates the transaction price to each performance obligation based upon managements estimate of the standalone selling price. Management must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. Management utilises key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts the Company would expect to receive for each performance obligation.
For variable consideration, the Company assesses the likelihood that a significant reversal of cumulative revenue will not occur, and amounts are recognized only if it is deemed to be highly probable that reversal will not occur. The Company utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration expected to be received.
For arrangements that include sales-based royalties and sales-based milestones and in which the license is deemed to be the predominant item to which the royalties relate, F-star recognizes royalty revenue upon the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
For R&D services, the customer pays the fixed amount based on a payment schedule. If the services rendered by the Company exceed the payment received, a contract asset is recognized. If the payments exceed the services rendered, a contract liability (deferred revenue) is recognized.
For milestone payments the revenue is recognized when the conditions stated in the contract for achievement of the milestone becomes probable. When R&D services income, license fees and milestone income are recognized over time, resource expended to date is used as the measure of progress of the performance obligations identified in the contract for the following reasons:
|
each performance obligation contains multiple deliverables; and |
|
resource expended has been assessed as the most accurate method of measuring progress towards completion of each performance obligation. |
2.17 |
Costs related to collaborative arrangements |
Costs related to collaborative agreements include all costs incurred which are directly attributable to the research and development activities which generate revenue under F-stars license and collaboration agreements. Where revenue includes the license of perpetual, exclusive intellectual property rights for in-process research and development that has been capitalized, an appropriate amount is charged to the statement of comprehensive income, based on an allocation of cost or value of the rights that have been licensed, which corresponds to the amount of the intangible asset derecognized from the balance sheet. Cost related to collaborative agreements also include full-time equivalent (FTE) labor costs and external R&D costs (for subcontracted research and
F-171
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
development activities), that have directly derived revenue, and amortization of capitalized intellectual property rights that have been acquired for the purpose of fulfilling the companys obligations under its License and Collaboration agreements.
2.18 |
Operating segments |
The company consists of a single operating reporting segment as defined under IFRS 8 Operating Segments.
3. |
Financial risk management |
3.1 |
Liquidity risk |
Liquidity risk is the risk that the Company will encounter difficulty in meeting its short-term obligations associated with financial liabilities.
Management monitors rolling forecasts of the Companys cash and cash equivalents on the basis of expected cash flows with the objective of ensuring that the Company has sufficient cash to meet all future obligations.
3.2 Cash flow risk, interest rate risk and sensitivity
Interest rate risk is the risk that changes in market interest rates will cause fluctuations to the fair values and cash flows of the Companys financial instrument holdings. The Companys exposure is minimal and so the Company does not employ risk mitigation strategies, such as interest rate swaps.
The Company has a loan agreement with a related party. Interest on this loan is calculated at an agreed rate of LIBOR plus 2% which will result in fluctuations in the amount of interest charged. If interest rates moved by +1%, a reasonably possible change in interest rates, the effect on profit before tax in the period ended May 6, 2019 would be £33,099 and the effect on loss before tax for the period ended December 31, 2018 would be £47,032 (2017: £37,775).
3.3 |
Currency risk |
Currency risk is the risk that changes in foreign exchange rates will cause fluctuations to the fair values and cash flows of the Companys financial instrument holdings that are denominated in a currency other than the functional currency in which they are measured. A change of 10% in the exchange rate against the euro, U.S. dollar or Swiss franc (CHF) would reduce/increase the equity of the Company as of the date of the statements of financial position as shown by the table below:
% change |
May 6,
2019 £ |
2018 £ |
2017 £ |
|||||||||||||
Euro |
10 | % | (48,301 | ) | (131,240 | ) | (66,668 | ) | ||||||||
U.S. dollar |
10 | % | (6,277 | ) | (234 | ) | (37 | ) | ||||||||
Swiss franc (CHF) |
10 | % | | 1,670 | |
The Company has an agreement in place with an external party, where further staged payments are expected to be received. These payments are receivable in U.S. dollars and changes in market exchange rates will cause fluctuations in the amounts recorded in the base currency, pounds sterling. The Company has not recognized future stage payments in its statements of financial position due to uncertainty of the future cash flows.
The Company seeks to match its foreign currency income with expenses in the same foreign currency wherever possible and consequently the Company holds foreign currency facilities with credit institutions to meet this aim.
F-172
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
3.4 |
Credit risk |
Credit risk is the risk of financial loss to the Company if the counterparty fails to meet its obligation. Credit risk arises from the Companys operating activities from receivables, financing activities from cash and cash equivalents and deposits with banks and financial institutions.
The Company has one customer with outstanding debt as of May 6, 2019 and December 31, 2018, (2017: one) with all other trade debts collected as of all reporting dates. The Company closely monitors the performance conditions under the contract with the customer ensuring that invoices are raised when performance conditions are met and that the payments terms with the customer are adhered to.
Credit risk from receivables is minimized by establishing credit policies such as determining and monitoring customer credit limits, requiring credit approvals and the monitoring of customer credit risks. Other monitoring procedures are in place to recover overdue customer accounts and to assess impairment.
Credit risk from financing activities is minimized by establishing investment policies in liquid securities with high credit ratings and maintaining accounts in reputable financial institutions with high quality credit ratings. All cash held by the Company is with financial institutions with a credit rating of F1+ or AA- according to Fitchs short term and long-term credit ratings.
3.5 |
Impairment of financial assets |
The Company applies the IFRS 9 simplified approach to measuring expected credit losses, which uses a lifetime expected loss allowance for amounts due from related parties.
The expected loss rates are based on the payment profile of the Companys customer. The historical loss rate is zero but has been adjusted to reflect current and forward-looking information on macroeconomic factors affecting the ability of the customer to settle the receivable.
Due to the related party status of the customer, management have access to detailed forecasts to aid assessment of the recovery of balances owed to the Company as of the reporting date. On that basis, any loss allowance as of May 6, 2019, December 31, 2018 and January 1, 2018 (on adoption of IFRS 9) was determined to be immaterial.
Amounts due from related parties are written off when there is no reasonable expectation of recovery. Indicators that there is no reasonable expectation of recovery include, amongst others, failure of a debtor to engage in a repayment plan and failure to make contractual payments for greater than 120 days past due.
While cash and cash equivalents and recoverable VAT are also subject to the impairment requirements of IFRS 9 the identified impairment loss was immaterial. Impairment on trade and other receivables and contract assets are presented as net impairment losses within operating profit. Subsequent recoveries of amounts previously written off are credited against the same line item.
3.6 |
Capital management |
The Company considers its equity to be its capital. Its objective is to manage this such that the Company has sufficient capital to remain liquid and to fund its activities. This is managed by quarterly assessment of future capital requirements, which is presented to management with recommendations for any action required to ensure that this this objective is met.
4. |
Critical accounting estimates and judgments |
Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances.
F-173
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
The company makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are addressed below.
In the application of the companys accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the year of the revision and future years if the revision affects both current and future years.
Key judgments and sources of estimation uncertainty relating to these financial statements are:
4.1 |
Judgments and estimates utilized to determine the amount and timing of revenue recognition |
The Companys revenues are generated through its intellectual property licensing and service arrangements with one external customer and the provision of intellectual property licenses and research and development (R&D) services to one related party. The following sections provide information regarding the nature and timing of the satisfaction of performance obligations under the contracts into which the Company has entered, which requires management to make significant estimates and judgments as described.
R&D Services and Option Agreement with collaboration partner
The Company has a R&D Services and Option Agreement with a collboration partner (the partner), under which it supplies intellectual property rights, R&D services to develop a number of immuno-oncology therapeutic bispecific antibodies and the option to acquire further intellectual property rights. The Company also receives milestone payments if certain stages of development are achieved. The contract includes multiple deliverables, however the intellectual property licensing and R&D services supplied are not deemed to be separate performance obligations. This is because the intellectual property rights granted are expected to be significantly modified by the R&D services also provided by the Company.
The option to acquire further rights is not considered to be a material right, as the option does not provide the partner with a discount that it would not have otherwise received. This is therefore deemed to not be a separate performance obligation.
Licensing income from the grant of intellectual property rights and R&D services provided as part of this arrangement are recognized using the cost-to-cost method to measure progress of completion of the performance obligation, which utilizes the total cost of labor incurred to the reporting date, relative to the total expected cost.
Success-based milestones represent variable consideration which is included in the transaction price only when it is highly probable that a significant reversal of cumulative recognized revenue will not occur.
Intellectual Property Licensing and Services Agreement with F-star Delta Limited
The Company has an intellectual property licensing agreement and a services agreement with a related party, F-star Delta Limited (Delta).
Management assessed that the R&D services are not distinct from the transfer of intellectual property rights, and therefore together they constitute a single combined performance obligation.
F-174
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
The intellectual property licensing and services agreement includes both fixed and variable consideration. At inception of the contract, management evaluated the total amount of consideration and the likelihood that each payment would be received. The amount included in the transaction price was constrained to the amount for which it is highly probable that a significant reversal of cumulative revenue recognized will not occur. At each reporting period management evaluate whether milestones and R&D services are considered highly probable of being reached and, to the extent that a significant reversal would not occur in future periods, estimate the amount to be included in the transaction price using the most likely amount method. There are no provisions in the existing agreement for returns or refunds.
The Company recognizes revenue using the cost-to-cost method, which it believes best depicts the transfer of control of the services to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation.
4.2 |
Useful life and impairment of intangible assets key estimates |
The Company has acquired intangible assets that consist of intellectual property rights from a third party. Management estimate that the useful life the assets to be the life of the underlying patents. However, the actual economic life may be longer than estimated due to potential regional patent term extensions which are currently unknown.
Management assesses whether acquired intangible assets have suffered any impairment at each reporting date, or sooner if there is an indication that the asset may be impaired. For the period ended May 6, 2019 and the year ended December 31, 2018 the recoverable amount of these assets was determined based on value-in-use calculations or fair value less cost of disposal calculations, which requires the use of assumptions and estimates. The current period calculations include a cost approach, which utilized net amount invested with a return on investment commensurate with the achievement of certain value inflection events. Management believes that a cost approach is more appropriate in the current period due to a changing competitor landscape for this asset, which makes it more difficult for future market share data to be calculated. However, although there is more uncertainty around the estimated future cash inflows relating to this asset, there is sufficient headroom at May 6, 2019 to satisfy management that no impairment is required.
The key assumptions used in the value-in-use calculations for the period ended May 6, 2019 are as follows:
May 6,
2019 |
||||
Obsolescence factor |
||||
2019 investment |
25 | % | ||
2018 investment |
50 | % | ||
2017 investment |
80 | % | ||
Value inflection events |
||||
Candidate selection |
3 | % | ||
CMC process determined |
12.5 | % |
F-175
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
Management has determined the values assigned to each of the above key assumptions as follows:
Assumption |
Approach to determining values | |
Obsolescence factor |
This relates to the cost incurred on an asset in a given year which has been discounted for an estimate of non-productive spend in that year (i.e. expenditure which has not been deemed to have increased the value of the asset). Management assessed this by examining all activities carried out in each year and determining the productivity of each activity. | |
Value inflection event |
These are events that would result in an increase or decrease of the value of an asset. Publicly traded comparable companies were identified that experienced similar events and the equity value was calculated one-day prior to the associated news release, as well as one-day, five-days, 10-days and 30-days post news release to measure the increase or decrease in value. |
The prior year calculations include cash flow projections based on financial budgets approved by management covering a three-year period. Cash flows beyond the three-year period were forecasted using published transition probabilities for development of product candidates, expected clinical trial design based upon the clinical development strategy for the candidates and industry analyst sales and gross margin projections for similar product candidates in the same target indications.
In the current period, management have assessed reasonably possible changes for key assumptions included in the impairment model and have concluded that there are no instances that would impact the carrying value of the intangible asset as at May 6, 2019.
The key assumptions used in the value-in-use calculations for the year ended December 31, 2018 are as follows:
Discount factor: 13.5%
In the year ended December 31, 2018, recoverable amount would equal the carrying amount if the key assumption was to change from 13.5% to 16.0%. The key assumptions used in the estimation of the recoverable amount are as set out below:
|
The values assigned to the key assumptions represented managements assessment of the future trends in the relevant industry and have been based on historical data from both external and internal source. |
|
The discount rate was estimated based on cost of equity and cost of debt. |
|
The cash flow projections included specific development estimates including cost of sales, cost of R&D, probability of success and amount and timing of projected future revenue. |
4.3 |
Revision of Previously Issued Financial Statements |
Intangible asset disclosure note 12
(extract) |
As previously
Patents 2018 £ |
Adjustment Patents 2018 £ |
As revised Patents 2018 £ |
|||||||||
Costs at beginning of period |
| | ||||||||||
Additions |
1,461,581 | 962,000 | 2,423,581 | |||||||||
Disposals |
(961,581 | ) | (962,000 | ) | (1,923,581 | ) | ||||||
|
|
|
|
|
|
|||||||
Cost at end of period |
500,000 | | 500,000 | |||||||||
|
|
|
|
|
|
|||||||
Total intangible assets |
483,949 | | 483,949 | |||||||||
|
|
|
|
|
|
F-176
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
Statement of cash flows (extract) |
As previously
2018 £ |
Adjustment 2018 £ |
As revised 2018 £ |
|||||||||
Payments to acquire intangible assets |
| 962,000 | 962,000 | |||||||||
Net cash used in operating activities |
(720,361 | ) | 962,000 | 241,639 | ||||||||
Payments to acquire intangible assets |
(1,461,581 | ) | (962,000 | ) | (2,423,581 | ) | ||||||
Net cash used in investing activities |
(1,461,581 | ) | (962,000 | ) | (2,423,581 | ) | ||||||
Intangible asset disclosure note 12
(extract) |
As previously
Patents 2017 £ |
Adjustment Patents 2017 £ |
As revised Patents 2017 £ |
|||||||||
Costs at beginning of period |
| | | |||||||||
Additions |
| 984,691 | 984,691 | |||||||||
Disposals |
| (984,691 | ) | (984,691 | ) | |||||||
|
|
|
|
|
|
|||||||
Cost at end of period |
| | | |||||||||
|
|
|
|
|
|
|||||||
Total intangible assets |
| | | |||||||||
|
|
|
|
|
|
|||||||
Statement of cash flows (extract) |
As previously
2017 £ |
Adjustment 2017 £ |
As revised 2017 £ |
|||||||||
Proceeds from sale of intangible assets |
| 984,691 | 984,691 | |||||||||
Net cash used in operating activities |
(2,958,511 | ) | 984,691 | (1,973,820 | ) |
5. |
Revenue |
The Company derives revenue from the transfer of goods and services over time in the following categories.
All revenue in the period ended May 6, 2019 and the year ended December 31, 2018 was generated from a single customer, which is a related party (F-star Delta Limited), located in the United Kingdom:
Provision of Licensing and R&D services |
Period to May 6, 2019 £ |
12 months December 31, 2018 £ |
||||||
Revenue from related party |
7,902,856 | 17,394,263 | ||||||
|
|
|
|
|||||
Total |
7,902,856 | 17,394,263 | ||||||
|
|
|
|
|||||
Timing of recognition: |
||||||||
Over time |
7,902,856 | 17,394,263 | ||||||
|
|
|
|
|||||
Total |
7,902,856 | 17,394,263 | ||||||
|
|
|
|
F-177
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
In the year ended December 31, 2017, revenue was generated in two geographic regions, the United Kingdom and the European Union. Revenue in the European Union was generated from a third party collaboration partner and revenue from a related party in the United Kingdom was generated from Delta.
YEAR ENDED DECEMBER 31, 2017 |
Licensing
£ |
Provision of R&D services £ |
Total^ £ |
|||||||||
Revenue from related party in the United Kingdom |
9,846,913 | 2,304,480 | 12,151,393 | |||||||||
|
|
|
|
|
|
|||||||
Timing of recognition: |
||||||||||||
At a point in time |
9,846,913 | | 9,846,913 | |||||||||
Over time |
| 2,304,480 | 2,304,480 | |||||||||
|
|
|
|
|
|
|||||||
Total from United Kingdom |
9,846,913 | 2,304,480 | 12,151,393 | |||||||||
|
|
|
|
|
|
|||||||
Revenue from European Union* |
2,841,850 | | 2,841,850 | |||||||||
|
|
|
|
|
|
|||||||
Timing of recognition: |
||||||||||||
Over time |
2,841,850 | | 2,841,850 | |||||||||
|
|
|
|
|
|
|||||||
Total from European Union |
2,841,850 | | 2,841,850 | |||||||||
|
|
|
|
|
|
|||||||
Total |
12,688,763 | 2,304,480 | 14,993,243 | |||||||||
|
|
|
|
|
|
* |
In the year ended December 31, 2017, the licensing income from a third party in the European Union represents the revenue recognized from the grant of intellectual property rights and the provisions of R&D services, which is deemed by management to represent a single performance obligation. |
^See note 2.4ii for details of a change in accounting policy.
Collaboration with Collaboration partner
In February 2015, the Company entered into an Option Agreement with a collaboration partner (the partner) pursuant to which the Company granted the partner the right to obtain a worldwide, exclusive license to certain of the Companys patents and know-how to develop, manufacture and commercialize up to a specified number of tetravalent bispecific antibody (mAb2) product candidates based on Fcabs directed at an immuno-oncology target in the field of the diagnosis, prevention and treatment of all diseases and conditions in humans or animals. Under certain circumstances, the partner has the right to select Fcabs to alternative targets to such original Fcabs.
Under the Option Agreement, the Company must, at its own expense, use commercially reasonable efforts to deliver Fcab sequences for the immuno-oncology target and to conduct certain mutually agreed upon research activities. Upon exercise of the option, the partner will become solely responsible for continued development, manufacture and commercialization of the applicable licensed products.
Pursuant to the Option Agreement, the Company received an aggregate initial payment of £4.2 million ($6.5 million) on February 17, 2015, and £1.6 million ($2.3 million) on January 15, 2016 and £6.1 million ($8.8 million) on February 17, 2016.
Under the the Option Agreement, the partner is obligated to pay the Company up to £85.4 million ($137.5 million) per mAb2 program in the aggregate upon the achievement of certain development and regulatory milestones. Additionally, under the Option Agreement, is obligated to pay the Company up to £118.2 million ($150.0 million) in the aggregate upon the achievement of certain commercial milestones. The Company is
F-178
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
eligible to receive tiered royalties ranging from a low-single digit to a high-single digit percentage of net sales of licensed products. The royalties payable to the Company under the Option Agreement may be reduced under certain circumstances. The Companys right to receive royalties under the Option Agreement expires, on a licensed product-by-licensed product and country-by-country basis, on the latest of: (i) the expiration, invalidation or abandonment date of the last valid licensed patent claim that covers such licensed product in such country, (ii) the expiration of regulatory exclusivity for such licensed product in such country and (iii) the tenth anniversary of the first commercial sale of such licensed product in such country.
Unless earlier terminated, the term of the Option Agreement will expire on the earlier of: (a) the date on which the partner has no further milestone or royalty obligations, or (b) on a target-by-target basis, the expiration of the applicable option period and the failure of the partner to exercise the applicable option prior to such expiration. The Company may terminate the Option Agreement if the partner or any sublicensee challenges any patent licensed to it under such agreement, subject to a right to cure in the case of a patent challenge by a sublicensee of the partner. Additionally, the Company may terminate the Option Agreement, on a target-by-target basis, under certain circumstances in the event that the partner ceases all development or commercialization activities with respect to the applicable licensed products under such agreement. The partner may terminate the Option Agreement, effective upon written notice to the Company, on a target-by target basis in the event that the partner in good faith believes it has safety concerns regarding continuing development or commercialization of a licensed product. The partner may terminate the Option Agreement either in its entirety or on a target-by target basis for convenience at any time effective upon 90 days prior written notice to the Company. Either party may terminate the agreement in the event of an uncured material breach under such agreement by the other party or for certain bankruptcy or insolvency events involving the other party. In the event of certain uncured breaches of the partnerparns diligence obligations, F-star may seek damages caused by such breach or seek specific performance in accordance with the terms of the Option Agreement.
Revenue recognition
The Company has considered whether the following obligations are distinct:
|
Grant of intellectual property rights for the purpose of evaluating the work performed by the Company |
|
Provision of R&D services |
Management concluded under IFRS 15 the grant of intellectual property rights is not distinct from the provision of R&D services, as the R&D services are expected to significantly modify the early stage intellectual property. As a result, the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for this contract. In the year ended December 31, 2017 this determination was different under IAS 18 Revenue see note 2.4 ii.
The total transaction price was initially determined to be £13.8 million consisting of the initial upfront payment and R&D funding for expected time to delivery of an antibody sequence to the partner. Variable consideration to be paid to the Company upon reaching certain milestones have been excluded from the calculation as it is not highly probable that a significant reversal of revenue recognized will not occur in a subsequent reporting period.
Revenue related to the initial upfront payment and R&D services provided was recognized over the estimated period to sequence delivery using the cost-to-cost method of measurement of progress to completion (see note 2.16). For the year ended December 31, 2017 the Company recognized £2.8 million, which related to the remaining unrecognized revenue as of January 1 2017 and the performance obligations were fully satisfied in August 2017.
F-179
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
Intellectual Property License Agreement with F-star Delta Limited
During the year ended 2017, the Company entered into an intellectual property licensing agreement with a related party, F-star Delta Limited. The license granted F-star Delta Limited exclusive intellectual property rights to develop, manufacture, commercialize and sub-license products generated from the use of the Companys proprietary technology. Additionally, a support services agreement was entered into by the Company and F-star Delta Limited for the supply of R&D services to F-star Delta Limited to develop bispecific antibodies to meet the obligation of its arrangement with Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany (Ares). Under the terms of the support services agreement the provision of R&D services is charged at a fixed full-time equivalent (FTE) rate, which is billed monthly as incurred.
In consideration for the grant of intellectual property rights to F-star Delta Limited, a proportion of any payments made to F-star Delta Limited under its license and collaboration agreement with Ares is paid to the Company. The percentage payable to the Company is tiered from 90% to 50%, depending upon the nature of each payment. The amount of the upfront licensing fee paid to F-star Delta Limited by its collaboration partner that was subsequently paid to the Company was £9.8 million.
The shareholders of F-star Delta Limited also entered into an option agreement with Ares which granted Ares the option to acquire the entire share capital of F-star Delta Limited. On exercise of the option, a payment equal to 20% of the proceeds of the sale would be received by the Company from F-star Delta Limited.
For product candidates being developed by F-star Delta Limited, but not included in the collaboration arrangements with Ares, the Company is eligible to receive £8.0 million in development milestones, £23.0 million in regulatory milestones and a low-single digit royalty percentage of net sales per product candidate.
Development milestone payments are triggered upon achievement by each product candidate of a defined stage of clinical development and regulatory milestone payments are triggered upon approval to market of a product candidate by the FDA or other global regulatory authorities.
The Company has considered whether the following obligations are distinct:
|
Grant of intellectual property rights |
|
Provision of R&D services |
Management assessed that the R&D services in the contract were not distinct from the transfer of intellectual property rights, and therefore together they constitute a single combined performance obligation because the R&D services are expected to significantly modify the early stage preclinical intellectual property.
Variable consideration to be paid to the Company upon reaching certain milestones has been excluded from the transaction price, as it is not highly probable that a significant reversal of cumulative revenue recognized will not occur in a subsequent reporting period.
Revenue recognition
For the year ended December 31, 2017, the Company recognized £9.8 million relating to the upfront license fee in accordance with IAS 18. Upon transition to IFRS 15, the promises within the contracts were determined to not be distinct and therefore a transition adjustment of £9.3 million was recorded as a decrease to retained earnings as a result of the combined performance obligation.
During the year ended December 31, 2018, one development milestone was achieved and R&D services were provided. The total transaction price estimate was increased to £26.6 million. £17.4 million of this total transaction price was recognized during the year ended December 31, 2018, based on the cost-to-cost method.
F-180
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
In the period ended May 6, 2019, R&D services were provided and the transaction price estimate was increased to £28.5 million. £7.9 million of this total transaction price was recognized during the period, based on the cost-to-cost method.
a. |
Assets and liabilities related to contracts with customers |
The Company has recognized the following liabilities related to contracts with customers:
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Deferred revenue related to upfront licensing fee, milestone income and R&D services income |
351,011 | 6,390,207 | | |||||||||
|
|
|
|
|
|
b. |
Revenue recognized in relation to contract liabilities |
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
Deferred revenue related to licensing income | £ | £ | £ | |||||||||
Contract liabilities at beginning of period (originally) |
6,390,207 | | 2,841,850 | |||||||||
Adoption of new accounting standard (2.4ii) |
| 9,340,724 | | |||||||||
Additional amounts deferred in the period |
240,450 | 3,470,504 | | |||||||||
Revenue recognized in the period included in opening contract liability |
(6,279,646 | ) | (6,421,021 | ) | (2,841,850 | ) | ||||||
|
|
|
|
|
|
|||||||
Contract liabilities at end of period |
351,011 | 6,390,207 | | |||||||||
|
|
|
|
|
|
Revenue recognized in the period to May 6, 2019 and the year 2018 not included in opening contract liability is £1.6 million and £11.0 million, respectively.
The following table shows the aggregate transaction price allocated to the remaining incomplete performance obligation.
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Transaction price allocated to outstanding performance obligation |
351,011 | 6,390,207 | 9,340,724 | |||||||||
|
|
|
|
|
|
As at May 6, 2019 the remaining 1% of the transaction price allocated to the unsatisfied contracts was expected to be recognized by June 4, 2019.
6. |
Costs related to collaborative arrangements |
Period ended May 6, 2019 |
Year ended
December 31, 2018 |
Year ended
December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Derecognition of intangible asset |
| 1,895,536 | 984,691 | |||||||||
Direct labor cost |
1,863,660 | 4,823,750 | 2,304,480 | |||||||||
|
|
|
|
|
|
|||||||
1,863,660 | 6,719,286 | 3,289,171 | ||||||||||
|
|
|
|
|
|
F-181
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
7. |
Other gains |
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Gain on foreign exchange differences |
| | 166,352 | |||||||||
Interest receivable |
| 815 | | |||||||||
|
|
|
|
|
|
|||||||
| 815 | 166,352 | ||||||||||
|
|
|
|
|
|
8. |
Loss from operations |
Loss from operations is stated after charging:
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Charged to research and development costs: |
||||||||||||
Amortization of intangible assets |
| 44,096 | | |||||||||
Charged to general and administrative costs: |
||||||||||||
Share based payment charge |
688,679 | 31,947 | 128,186 |
The company had no employees during the period ended May 6, 2019 and the year ended December 31, 2018 (2017: none).
9. |
Finance costs |
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Interest payable on loan from related party |
103,216 | 144,677 | 101,825 | |||||||||
|
|
|
|
|
|
10. |
Key management personnel remuneration |
Remuneration to key management personnel is paid by a related party, F-star Biotechnology Limited. Amounts shown below relate to the allocation of remuneration to F-star Beta Limited. In addition to the Statutory Directors, who were in office as of May 6, 2019 , December 31, 2018 and December 31, 2017, key management personnel also included the Chief Business Officer and Chief Scientific Officer.
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Aggregate compensation |
161,038 | 563,437 | 476,552 | |||||||||
Compensation for loss of office |
| 131,797 | | |||||||||
Company pension contributions to money purchase pension schemes |
3,456 | 22,019 | 21,194 | |||||||||
Share-based payment charge |
688,679 | | | |||||||||
|
|
|
|
|
|
|||||||
853,173 | 717,253 | 497,746 | ||||||||||
|
|
|
|
|
|
F-182
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
11. |
Corporation tax benefit |
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Current benefit for the year |
639,359 | 2,429,980 | 705,465 | |||||||||
Adjustments for current tax of prior periods |
| (14,012 | ) | | ||||||||
|
|
|
|
|
|
|||||||
Total current tax benefit |
639,359 | 2,415,968 | 705,465 | |||||||||
|
|
|
|
|
|
Factors affecting tax credit for the year
The expected tax credit for the year based on the standard UK tax rate for the period ending May 6, 2019, and the year ended December 31, 2018 of 19% (2017: 19.25%) and the reported tax credit for the year can be reconciled as shown below:
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Loss before tax |
(137,399 | ) | (1,883,335 | ) | (516,763 | ) | ||||||
|
|
|
|
|
|
|||||||
Profit/ loss before tax multiplied by the standard rate of corporation tax in the United Kingdom for the year of 19% (2017: 19.25%) |
26,106 | 357,834 | 99,459 | |||||||||
|
|
|
|
|
|
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Additional deduction for R&D expenditure |
962,732 | 1,799,715 | 861,611 | |||||||||
Surrender of tax losses for R&D tax credit |
(857,989 | ) | (3,904,716 | ) | (936,399 | ) | ||||||
Share-based payments |
(130,849 | ) | (6,070 | ) | (24,671 | ) | ||||||
Tax credits on R&D expenditure |
639,359 | 2,429,980 | 705,465 | |||||||||
Expenses not deducted for tax purposes |
| (21,501 | ) | | ||||||||
Adjustment for current tax prior periods |
| (14,012 | ) | | ||||||||
Impact of change in accounting policy |
| 1,774,738 | | |||||||||
|
|
|
|
|
|
|||||||
Actual tax benefit for the period/year |
639,359 | 2,415,968 | 705,465 | |||||||||
|
|
|
|
|
|
Changes to the UK corporation tax rates were substantively enacted as part of Finance Bill 2015 (on October 26, 2015) and Finance Bill 2016 (on September 7, 2016). These include changes to the main rate to reduce the rate to 19% from April 1, 2017 and to 17% from April 1, 2020. Deferred taxes as of the date of the statements of financial position have been measured using these enacted tax rates and reflected in these financial statements.
F-183
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
No deferred tax asset has been recognized due to the current uncertainty of future taxable profits. The asset will be recognized when sufficient taxable profits are generated to relieve the losses and other temporary differences reverse. The amounts not recognized were as follows:
Period ended May 6, 2019 |
Year ended December 31, 2018 |
Year ended December 31, 2017 |
||||||||||
£ | £ | £ | ||||||||||
Share-based payments |
276,149 | 159,074 | 153,643 | |||||||||
Carried forward tax losses |
644,751 | 644,751 | | |||||||||
|
|
|
|
|
|
|||||||
Deferred tax asset (unrecognized) |
920,900 | 803,825 | 153,643 | |||||||||
|
|
|
|
|
|
12. |
Intangible assets |
Patents May 6, 2019 £ |
Restated* Patents 2018 £ |
Restated* Patents 2017 £ |
||||||||||
Costs at beginning of period |
500,000 | | | |||||||||
Additions |
50,000 | 2,423,581 | 984,691 | |||||||||
Disposals |
| (1,923,581 | ) | (984,691 | ) | |||||||
|
|
|
|
|
|
|||||||
Cost at end of period |
550,000 | 500,000 | | |||||||||
|
|
|
|
|
|
|||||||
Accumulated amortization at beginning of period |
16,051 | | | |||||||||
Amortization charge |
| 44,096 | | |||||||||
Disposals |
| (28,045 | ) | | ||||||||
|
|
|
|
|
|
|||||||
Accumulated amortization at end of period |
16,051 | 16,051 | | |||||||||
|
|
|
|
|
|
|||||||
Net book value as of May 6, /December 31, |
533,949 | 483,949 | | |||||||||
|
|
|
|
|
|
* |
See note 4.3 for for revision of previously issued financial statements for correction of an error. |
All intangible assets are attributable to research and development activities conducted in the United Kingdom. g
13. |
Trade and other receivables |
May 6, 2019 |
2018 | 2017 | ||||||||||
Due within one year |
£ | £ | £ | |||||||||
Unpaid share capital |
2 | | | |||||||||
Amounts due from related parties |
603,701 | 416,236 | 730,489 | |||||||||
VAT recoverable |
119,722 | 121,278 | 82,756 | |||||||||
Prepayments |
484,918 | 246,998 | 21,648 | |||||||||
|
|
|
|
|
|
|||||||
1,208,343 | 784,512 | 834,893 | ||||||||||
|
|
|
|
|
|
Amounts due from related parties are amounts due for R&D services performed and payments due under intellectual property licensing agreements. They are due for settlement within 30 days and therefore are all classed as current. Amounts due from related parties are recognized initially at the amount of consideration that is unconditional, as they do not contain any significant financing components. The Company holds the amounts due from related parties with the intention to collect the contractual cash flows and therefore measures them subsequently at amortized cost using the effective interest method (see note 15).
F-184
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
There are no receivables past due as of May 6, 2019, December 31, 2018 or December 31, 2017. The Company does not hold any collateral as security. The carrying amount of the Companys trade and other receivables is denominated in GBP.
14. |
Cash and cash equivalents |
May 6, 2019 £ |
2018 £ |
2017 £ |
||||||||||
Cash and bank balances |
915,436 | 5,709,474 | 1,909,973 | |||||||||
|
|
|
|
|
|
Cash and cash equivalents comprise cash held by the Company.
15. |
Issued capital |
The Companys articles of association do not specify the authorized share capital of the entity.
May 6, 2019 £ |
2018
£ |
2017
£ |
||||||||||
Issued capital |
93 | 91 | 91 | |||||||||
|
|
|
|
|
|
Issued capital comprises:
May 6, 2019 £ |
2018
£ |
2017
£ |
||||||||||
239,311 unpaid ordinary shares as at May 6, 2019 (December 31, 2018 and 2017, nil) |
2 | | | |||||||||
1,189,098 at May 6, 2019 and December 31, 2018 (2017: 1,189,098) fully paid ordinary shares of £0.00001 |
12 | 12 | 12 | |||||||||
27,188 at May 6, 2019 and December 31, 2018 (2017: 27,188) fully paid deferred ordinary shares of £0.00001 |
| | | |||||||||
7,923,146 at May 6, 2019 and December 31, 2018 (2017: 7,923,146) fully paid series A preferred shares of £0.00001 |
79 | 79 | 79 | |||||||||
|
|
|
|
|
|
|||||||
93 | 91 | 91 | ||||||||||
|
|
|
|
|
|
On March 6, 2019 239,311 ordinary shares were issued to a director at nominal value. This issue resulted in a share-based payment expense of £724,661 (see note 17).
Ordinary shares have attached to them full voting, dividend and capital distribution (including on winding up) rights. They do not confer any rights to redemption. Deferred ordinary shares do not have voting or dividend rights. They do not confer any rights of redemption. Series A preferred shares have attached to them full voting rights. In a distribution scenario, capital is returned in the following order:
(a) |
First in paying to the holders of the deferred ordinary shares, if any, a total of one penny for the entire class of Deferred Shares (which payment shall be deemed satisfied by payment to any one holder of Deferred Shares); and |
(b) |
Secondly, the balance of the surplus assets (if any) shall be distributed among the holders of the ordinary shares (including those that are exercised under the rules of the share option scheme) and the preference shares pro rata (as if the ordinary shares and preferred shares constituted one and the same class). |
F-185
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
16. |
Financial instruments |
a. |
Maturity of financial liabilities |
The maturity profile of the Companys financial liabilities as of May 6 or December 31, was as follows:
May 6, 2019 |
December 31, 2018 |
December 31, 2017 |
||||||||||
Amounts repayable: |
£ | £ | £ | |||||||||
In one year or less |
13,352,608 | 12,184,899 | 5,421,048 | |||||||||
|
|
|
|
|
|
b. |
Financial Instruments by Category |
The Company has classified its financial assets and liabilities into the following measurement groups with the fair values as stated in the table below:
May 6, 2019 Amortized cost |
2018 Amortized cost |
2017 Amortized cost |
||||||||||
Assets |
£ | £ | £ | |||||||||
Cash and cash equivalents |
915,436 | 5,709,474 | 1,909,973 | |||||||||
Trade and other receivables (excluding VAT recoverable and prepayments) |
603,701 | 416,236 | 730,489 | |||||||||
|
|
|
|
|
|
|||||||
1,519,137 | 6,125,710 | 2,640,462 | ||||||||||
|
|
|
|
|
|
May 6,
2019 Financial
|
2018
Financial
cost |
2017 Financial Liabilities
measured at
cost |
||||||||||
Liabilities |
£ | £ | £ | |||||||||
Trade and other payables |
13,352,608 | 12,184,899 | 5,421,048 | |||||||||
|
|
|
|
|
|
17. |
Trade and other payables |
May 6, 2019 £ |
2018 £ |
2017 £ |
||||||||||
Trade payables |
179,218 | 626,589 | 440,810 | |||||||||
Amount due to related parties |
11,318,271 | 10,955,911 | 4,804,235 | |||||||||
Accrued expenses |
1,855,119 | 602,399 | 176,003 | |||||||||
|
|
|
|
|
|
|||||||
13,352,608 | 12,184,899 | 5,421,048 | ||||||||||
|
|
|
|
|
|
No interest is charged on trade payables. The payables due to related parties includes a loan received from F-star Biotechnology Limited, a related party company. The loan is repayable on demand and further details are described in note 18.
F-186
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
Management considers that the carrying amount of the payables approximates to their fair value. The carrying amount of the Companys trade and other payables are denominated in the following currencies:
May 6, 2019 £ |
2018 £ |
2017 £ |
||||||||||
Pound sterling |
13,260,920 | 11,950,214 | 5,043,950 | |||||||||
Euro |
82,952 | 177,659 | 376,567 | |||||||||
U.S. dollar |
8,736 | 38,652 | 531 | |||||||||
Swiss franc |
| 18,374 | | |||||||||
|
|
|
|
|
|
|||||||
13,352,608 | 12,184,899 | 5,421,048 | ||||||||||
|
|
|
|
|
|
18. |
Share-based payments |
Employees of F-star Biotechnology Limited, a related party (see note 18), have been granted options to purchase ordinary shares of the Company. The total charge for the year relating to share based payments was £688,679 for the period ended May 6, 2019 and £31,947 for the year ended December 31, 2018 (2017: £128,186), all of which related to equity-settled share-based payment transactions.
A reconciliation of option movements over the period to May 6, 2019 and the year to December 31, 2018 together with their related weighted average exercise price is shown below:
May 6,
2019 |
May 6,
2019 |
2018 | 2018 | 2017 | 2017 | |||||||||||||||||||
Number |
Weighted
average exercise price |
Number |
Weighted
average exercise price |
Number |
Weighted
average exercise price |
|||||||||||||||||||
Outstanding as of the beginning of period |
219,884 | 0.00001 | 223,218 | 0.00001 | 239,649 | 0.00001 | ||||||||||||||||||
Options forfeited |
| 0.00001 | (3,334 | ) | 0.00001 | (16,431 | ) | 0.00001 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Outstanding as of the end of period |
219,884 | 0.00001 | 219,884 | 0.00001 | 223,218 | 0.00001 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Exercisable as of the end of period |
| | | | | | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
No share options were exercised during the period ended May 6, 2019 or the years ended December 31, 2018 and 2017. No unvested options were forfeited in the period ended May 6, 2019 and 3,334 unvested options for four employees (2017: 16,431, for seven leavers) were forfeited in the year ended December 31, 2018 upon termination of employment.
Share options outstanding as of May 6, 2019 have the following exercise prices:
Exercise price
of share option |
Fair value
as of date of grant |
|||||||||||||
Grant date |
Scheme | £ | £ | Number | ||||||||||
April September 2015 |
F-star Beta Limited Share Option Scheme | 0.00001 | 4.53 | 139,849 | ||||||||||
April September 2016 |
F-star Beta Limited Share Option Scheme | 0.00001 | 4.53 | 99,800 |
Share options granted to employees of F-star Biotech have an exercise price of £0.00001 (2017: £0.00001). Vesting started from the later of October 8, 2013 and commencement of employment with F-star Biotech with
F-187
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
33% of the options vesting on the first anniversary following commencement of employment and the remaining 67% vesting on a monthly basis over the following two years.
The weighted average fair value of options was determined using the Black-Scholes model. The significant inputs into the model were share price of £4.53, exercise price of £0.00001, volatility of 50%, dividend yield of 0%, an expected option life of 4.29 years and an annual risk-free rate of 0.25%.
Share options granted to founders vested immediately.
All vested options are only exercisable in the event of an exit, in line with the scheme rules.
The options have a contractual option term of 10 years from the date of grant with the weighted average remaining contractual life of 5.5 years as of May 6, 2019.
19. |
Related party transactions |
The directors of F-star Beta Limited with the exception of Eliot Forster, John Fitzpatrick, Tolga Hassan and John Haurum are also members of the supervisory board of f-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H which has a wholly owned subsidiary, F-star Biotechnology Limited. Both f-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H and F-star Biotechnology Limited are related parties by virtue of the existence of common Directors.
The Directors of F-star Beta Limited are also Directors of F-star Delta Limited. F-star Beta Limited and F-star Delta Limited are considered to be related parties by virtue of the existence of common Directors. Transactions in the period ended May 6, 2019 and the year ended December 31, 2018 with related parties were as follows:
Interest payable | Payable | |||||||||||||||||||||||
Period ended
May 6, |
Year ended December 31, |
Period ended
May 6, |
Balance as of December 31, |
|||||||||||||||||||||
2019 | 2018 | 2017 | 2019 | 2018 | 2017 | |||||||||||||||||||
£ | £ | £ | £ | £ | £ | |||||||||||||||||||
Loans |
||||||||||||||||||||||||
Loan payable to related party |
103,216 | 144,677 | 101,825 | 10,048,305 | 10,067,632 | 3,941,513 |
Expenses | Payable | |||||||||||||||||||||||
Period ended
May 6, |
Year ended
December 31, |
Period ended
May 6, |
Balance as of
December 31, |
|||||||||||||||||||||
2019 | 2018 | 2017 | 2019 | 2018 | 2017 | |||||||||||||||||||
£ | £ | £ | £ | £ | £ | |||||||||||||||||||
Costs/licenses |
||||||||||||||||||||||||
Recharged from related party |
4,226,502 | 13,302,779 | 11,946,845 | 1,449,185 | 853,785 | 837,311 |
The payable due to related party as at May 6, 2019 includes a related party debtor of £1,269,967 (December 31, 2018 £853,785 and December 31, 2017 £837,111) and a balance of £211,977 (December 31, 2018 and 2017: £nil) included within accrued expenses.
Income | Receivable | |||||||||||||||||||||||
Period ended
May 6, |
Year ended
December 31, |
Period ended
May 6, |
Balance as of
December 31, |
|||||||||||||||||||||
2019 | 2018 | 2017 | 2019 | 2018 | 2017 | |||||||||||||||||||
£ | £ | £ | £ | £ | £ | |||||||||||||||||||
Costs/licenses |
||||||||||||||||||||||||
Recharged to related party |
8,332,624 | 17,633,167 | 14,071,644 | 603,701 | 416,236 | 730,489 |
During 2016 the Company and F-star Biotechnology Limited entered into an intellectual property license agreement and a support services agreement whereby the Company licensed intellectual property from F-star
F-188
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
Biotechnology Limited, and F-star Biotechnology Limited agreed to provide support services to the Company. Expenses also included the license fee paid to F-star Biotechnology Limited.
Expenses also include research paid for by the Company and carried out by F-star Biotechnology Limited. These research services are based on time incurred and are charged on a FTE basis. In addition, certain non-employment related costs associated with the research activities of the Company were incurred by F-star Biotechnology Limited and recharged to the Company.
During the year ended December 31, 2017 the Company entered into an intellectual property license agreement and a support services agreement whereby the Company licensed intellectual property to F-star Delta Limited, and the Company agreed to provide support services to F-star Delta Limited. Income above includes license fees payable to F-star Beta Limited. Income also includes research paid for by the Company but recharged to F-star Delta Limited. These research services are based on time incurred and are charged on a FTE basis. In addition, certain non-employment related costs associated with the research activities were incurred by the Company and recharged to the F-star Delta Limited.
During the year ended December 31, 2016 F-star Beta Limited borrowed £1.2 million from F-star Biotechnology Limited. An additional £4.8 million was loaned from F-star Biotechnology Limited in 2017 and £2 million subsequently repaid. A further £6.1 million was loaned in the year ended December 31, 2018. The loan agreement is subject to a maximum loan value of £15 million. Interest is settled quarterly in arrears at a rate of LIBOR plus 2%. This loan is repayable on demand. The outstanding loan amount, including accrued interest, as of May 6, 2018 was £10.0 million, and as of December 31, 2018 was £10.1 million (2017: £3.9 million) and is included in Trade and Other Payables: Amount due to related parties.
During the period ended May 6, 2019 and year ended December 31, 2018, f-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H. invoiced the Company £22,995 and £150,424 (2017: £109,284) for its portion of board costs. As of May 6, 2019 and December 31, 2018, £nil and £30,414 (2017: £25,411) was outstanding respectively, and is included in Trade and other payables: Amount due to related parties.
Key management personnel
Transactions with key management (all remuneration-related) are disclosed in note 9.
20. |
Commitments |
Under the terms of an existing license agreement between the Company and F-star Biotechnology Limited, a related party, 10% of the payments received by the Company from the transaction with its collaboration partner and the transaction with F-star Delta Limited are contractually due to F-star Biotechnology Limited. Additionally, development milestones and royalties are payable to F-star Biotechnology Limited as licensed products progress through the development pipeline to commercialization. Under the terms of the same agreement, in the event that a third party acquires the entire issued share capital of the Company, the Company may elect to pay 20% of the amount paid by the third party to F-star Biotechnology Limited in substitution for any future contracted amounts payable.
The Company has contracted commitments with a contract manufacturing organization (CMO) as of May 6, 2019 of £7.9 million and December 31, 2018 amounting to £4.4 million (2017: £nil) for activities that are ongoing or are scheduled to start within 3 or 6 months of the date of the statements of financial position. Under the terms of the agreement with the CMO, the Company is committed to pay for some activities if they are cancelled up to 3 or 6 months prior to the start date of the activity.
F-189
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
The Company has no other obligations under non-cancellable operating leases nor significant capital expenditure contracted for, but not recognized as a liability.
21. |
Earnings per share |
The calculation of basic and diluted earnings per share is based on the following data:
Earnings |
May 6,
2019 £ |
2018
£ |
2017
£ |
|||||||||
Earnings for the purposes of basic and diluted earnings per ordinary share |
72,369 | 69,299 | 24,551 | |||||||||
|
|
|
|
|
|
|||||||
Number of shares |
May 6,
2019 £ |
2018
£ |
2017
£ |
|||||||||
Weighted average number of shares for the purposes of basic and diluted earnings per ordinary share |
1,305,882 | 1,189,098 | 1,189,098 | |||||||||
|
|
|||||||||||
Basic earnings per ordinary share |
0.05 | 0.06 | 0.02 | |||||||||
Diluted earnings per ordinary share |
0.05 | 0.06 | 0.02 |
21. |
Subsequent events |
Until May 7, 2019, there was no ultimate controlling party of the Company. On May 7, 2019, the Company was acquired by F-star Therapeutics Limited, a company incorporated in the United Kingdom. Shares in F-star Therapeutics Limited were issued to the shareholders of the Company in consideration for 100% of the issued share capital of the Company. From May 7, 2019, F-star Therapeutics Limited is considered to be the ultimate controlling party.
On May 14, 2019 Delta signed a new agreement with Ares, which resulted in an amendment of the agreements between Delta and Beta. The performance obligations arising from the new agreement were deemed by management to be separate from those in the original agreement, and the amendment resulted in the completion of all performance obligations by Beta under the original agreement on May 14, 2019. Under the intellectual property licence between Beta and Delta, 90% of any upfront payments made to Delta by external partners are paid to Beta and therefore Beta recognized revenue of £8.1 million (9.0 million) in July 2019.
On July 15, 2020, a deed of amendment was enacted in respect of the May 13, 2019 License and Collaboration agreement between Delta and Ares Trading S.A. The amendment had two main purposes (i) to allow Ares to exercise its option early to acquire intellectual property rights to the second molecule included in the agreement; and (ii) to grant additional options to acquire intellectual property rights for a further two molecules.On early exercise of the option, an amount of £6.2 million (6.8 million) was payable from Delta to company.
On September 16, 2019, the Companys collaboration patner gave notice to F-star Beta Limited of the discontinuation of the collaboration and license agreement. All rights and intellectual property granted pursuant to the license agreement revert to and are retained by F-star Beta Limited.This event did not have a material impact on the Companys financial statements.
On March 11, 2020 the World Health Organization declared the novel strain of coronavirus (COVID-19) a global pandemic and recommended containment and mitigation measures worldwide. It is likely that the outbreak will impact the Companys operations, but at the date of the signing of the financial statements management cannot
F-190
F-STAR BETA LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE PERIOD ENDED MAY 6, 2019, AND THE YEAR ENDED DECEMBER 31, 2018 AND 2017
reasonably estimate the length or severity of the pandemic or the extent to which the disruption may materially impact the business. Management took the decision in April 2020 to furlough a significant proportion of the R&D workforce and so project timelines may be delayed, which could impact the significant accounting estimates utilized in assessment of impairment of intangible assets.
At this point it is not clear whether any project delays can be mitigated in the second half of 2020. Any adverse impact on operations, business or financial outlook could be material and management continues to closely monitor the situation.
On July 29, 2020, the ultimate parent entity F-star Therapeutics (F-star) entered into a share exchange agreement with Spring Bank Pharmaceuticals Inc (Spring Bank), a NASDAQ- listed, clinical-stage biopharmaceutical company. Pursuant to the share exchange agreement, Spring Bank will acquire the entire issued share capital of F-star in exchange for newly issued shares of Spring Bank common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the required approval of Spring Bank stockholders.
Spring Bank shareholders will have the opportunity to obtain potential future value in the form of two Contingent Value Rights (CVR) associated with Spring Banks SB 11285 IV clinical program and a STING antagonist research and development program. Subject to the terms of the first CVR agreement for the STING agonist clinical program, if one or more strategic transactions are consummated for SB 11285 by the combined company during a period that is the longer of one and a half years following the closing of the combination or one year after the final database lock of the current SB 11285 IV Phase 1a/1b trial, those equity holders of Spring Bank will receive the greater of 25% of the net proceeds from such transactions or $1.00 per share (on a pre-reverse split basis), provided that the aggregate net proceeds are at least approximately $18.0 million. Subject to the terms of the second CVR agreement, if a potential development agreement is consummated and one or more strategic transactions are consummated for the STING antagonist research platform by the combined company during the seven (7)-year period following the closing of the combination, those equity holders of Spring Bank will receive 80% of the net proceeds from such transactions. If Spring Bank enters into a development agreement for the STING antagonist research platform in advance of the closing of the proposed combination, Spring Bank may include certain proceeds from such transaction in its net cash calculation.
F-191
Index to Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2020 and for the 6 months ended June 30, 2020 and 2019
F-193
Unaudited Condensed Consolidated Statements of Comprehensive Loss
6 months ended | ||||||||||
Notes |
June 30, 2020 £ |
June 30, 2019 £ |
||||||||
Revenue |
3 | 1,537,440 | 20,153,798 | |||||||
Costs related to collaborative arrangements |
4 | (332,804 | ) | (17,436,956 | ) | |||||
Research & development costs |
6 | (7,422,539 | ) | (9,574,755 | ) | |||||
General & administrative expenses |
6 | (4,960,307 | ) | (3,764,447 | ) | |||||
Other income |
5 | 371,115 | | |||||||
Other expenses |
(1,282,426 | ) | (242,656 | ) | ||||||
|
|
|
|
|||||||
Loss from operations |
(12,089,521 | ) | (10,865,016 | ) | ||||||
|
|
|
|
|||||||
Fair value losses on financial liabilities at fair value through profit or loss (FVTPL) |
9 | (1,508,796 | ) | | ||||||
Finance income |
8,290 | 857 | ||||||||
Finance costs |
(437,548 | ) | | |||||||
|
|
|
|
|||||||
Loss before tax from continuing operations |
(14,027,575 | ) | (10,864,159 | ) | ||||||
|
|
|
|
|||||||
Income tax credit |
2,691,554 | 755,926 | ||||||||
|
|
|
|
|||||||
Loss for the year attributable to equity holders of the parent |
(11,336,021 | ) | (10,108,233 | ) | ||||||
|
|
|
|
|||||||
Items that may be reclassified to profit or loss in subsequent periods: |
||||||||||
Foreign exchange arising on consolidation |
566,551 | 430,639 | ||||||||
|
|
|
|
|||||||
Other comprehensive income for the period |
566,551 | 430,639 | ||||||||
|
|
|
|
|||||||
Total comprehensive loss attributable to owners of the parent |
(10,769,470 | ) | (9,677,594 | ) | ||||||
|
|
|
|
|||||||
Loss per share for profit attributable to the shareholders of the parent: |
||||||||||
Basic and diluted loss per share |
14 | (0.64 | ) | (0.86 | ) |
All activities relate to continuing activities.
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.
F-194
Unaudited Condensed Consolidated Statements of Financial Position
Notes |
June 30, 2020 £ |
December 31,
£ |
||||||||||
Non-current assets |
||||||||||||
Goodwill |
2,811,827 | 2,811,827 | ||||||||||
Intangible assets |
33,368,882 | 34,134,321 | ||||||||||
Property, plant and equipment |
814,023 | 1,086,781 | ||||||||||
Right-of-use assets |
218,907 | 462,520 | ||||||||||
Financial assets held at FVTPL |
7 | 45,712 | 42,662 | |||||||||
|
|
|
|
|||||||||
37,259,351 | 38,538,111 | |||||||||||
Current assets |
||||||||||||
Cash and cash equivalents |
8 | 2,155,101 | 3,736,229 | |||||||||
Current tax assets |
3,448,073 | 8,114,658 | ||||||||||
Trade and other receivables |
2,019,879 | 2,713,144 | ||||||||||
|
|
|
|
|||||||||
7,623,053 | 14,564,031 | |||||||||||
|
|
|
|
|||||||||
Total assets |
44,882,404 | 53,102,142 | ||||||||||
|
|
|
|
|||||||||
Equity |
||||||||||||
Issued share capital |
178,109 | 177,768 | ||||||||||
Other reserves |
45,261,794 | 45,261,794 | ||||||||||
Accumulated losses |
(26,817,953 | ) | (16,907,806 | ) | ||||||||
|
|
|
|
|||||||||
Total equity |
18,621,950 | 28,531,756 | ||||||||||
|
|
|
|
|||||||||
Non-current liabilities |
||||||||||||
Lease liability |
9 | | 39,745 | |||||||||
Deferred tax |
1,297,333 | 1,655,295 | ||||||||||
|
|
|
|
|||||||||
1,297,333 | 1,695,040 | |||||||||||
Current liabilities |
||||||||||||
Convertible notes held at FVTPL |
9 | 14,404,757 | 11,364,454 | |||||||||
Corporate tax liabilities |
95,496 | 84,317 | ||||||||||
Trade and other payables |
9,898,729 | 10,621,957 | ||||||||||
Deferred revenue |
3 | 321,243 | 339,558 | |||||||||
Lease liability |
9 | 242,896 | 465,060 | |||||||||
|
|
|
|
|||||||||
Total current liabilities |
24,963,121 | 22,875,346 | ||||||||||
|
|
|
|
|||||||||
Total equity and liabilities |
44,882,404 | 53,102,142 | ||||||||||
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F-195
Unaudited Condensed Consolidated Statements of Changes in Equity
Notes |
Share capital £ |
Other
£ |
(Retained
accumulated
£ |
Total equity £ |
||||||||||||||||
Balance at January 1, 2019 |
1 | 90 | 15,861,034 | 15,861,125 | ||||||||||||||||
Loss for the half year |
| | (10,108,233 | ) | (10,108,233 | ) | ||||||||||||||
Other comprehensive income |
| | 430,639 | 430,639 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
1 | 90 | 6,183,440 | 6,183,531 | |||||||||||||||||
Transactions with owners in their capacity as owners |
||||||||||||||||||||
Share based payment charge |
10 | | | 1,018,812 | 1,018,812 | |||||||||||||||
Issues of shares on capital reorganization, business combination and acquisition of asset |
177,415 | 45,261,704 | | 45,439,119 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2019 |
177,416 | 45,261,794 | 7,202,252 | 52,641,462 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Balance as at January 1, 2020 |
177,768 | 45,261,794 | (16,907,806 | ) | 28,531,756 | |||||||||||||||
Loss for the half year |
| | (11,336,021 | ) | (11,336,021 | ) | ||||||||||||||
Other comprehensive income |
| | 566,551 | 566,551 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
177,768 | 45,261,794 | (27,677,276 | ) | 17,762,286 | ||||||||||||||||
Transactions with owners in their capacity as owners |
||||||||||||||||||||
Share based payment charge |
10 | | | 859,323 | 859,323 | |||||||||||||||
Exercise of share options |
341 | | | 341 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
At June 30, 2020 |
178,109 | 45,261,794 | (26,817,953 | ) | 18,621,950 | |||||||||||||||
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F-196
Unaudited Condensed Consolidated Statements of Cash Flows
6 months ended | ||||||||||||
Notes |
June 30, 2020 £ |
June 30, 2019 £ |
||||||||||
Cash flows from operating activities |
||||||||||||
Loss for the half year before tax |
(14,027,575 | ) | (10,864,159 | ) | ||||||||
Adjustments for: |
| |||||||||||
Share-based payment expense |
10 | 859,323 | 1,018,812 | |||||||||
Net finance cost |
427,663 | (857 | ) | |||||||||
Net exchange loss |
1,280,538 | 244,563 | ||||||||||
Amortization of intangible assets |
4,6 | 776,249 | 766,836 | |||||||||
Depreciation on tangible fixed assets and right of use assets |
6 | 470,201 | 164,910 | |||||||||
Loss on disposal of tangible fixed asset |
5,625 | | ||||||||||
Loss on disposal of intangible asset |
| 3,953,127 | ||||||||||
Impairment of intangible assets |
6 | | 1,800,684 | |||||||||
Fair value losses on financial liabilities through profit or loss |
9 | 1,508,796 | | |||||||||
Trade and other receivables |
693,265 | (9,490,006 | ) | |||||||||
Trade and other payables |
(723,228 | ) | 4,819,776 | |||||||||
Change in deferred revenue |
(18,315 | ) | (4,717,253 | ) | ||||||||
|
|
|
|
|||||||||
Adjusted loss before tax |
(8,747,458 | ) | (12,303,567 | ) | ||||||||
Proceeds from sale of intangible assets |
| 8,620,965 | ||||||||||
|
|
|
|
|||||||||
Cash used in operating activities |
(8,747,458 | ) | (3,682,602 | ) | ||||||||
Corporation tax received |
7,019,203 | | ||||||||||
|
|
|
|
|||||||||
Net cash flows used in operating activities |
(1,728,255 | ) | (3,682,602 | ) | ||||||||
|
|
|
|
|||||||||
Cash flows from investing activities |
||||||||||||
Payments to acquire intangible assets |
| (100,000 | ) | |||||||||
Cash acquired on business combinations* |
| 4,194,521 | ||||||||||
Interest received |
8,290 | 857 | ||||||||||
|
|
|
|
|||||||||
Net cash generated from investing activities |
8,290 | 4,095,378 | ||||||||||
|
|
|
|
|||||||||
Cash flows from financing activities |
||||||||||||
Principal elements of lease payments |
(221,364 | ) | (83,374 | ) | ||||||||
Interest paid on leases |
(9,885 | ) | (5,497 | ) | ||||||||
Proceeds from convertible debt |
9 | 405,357 | | |||||||||
|
|
|
|
|||||||||
Net cash generated from/(used in) financing activities |
174,108 | (88,871 | ) | |||||||||
|
|
|
|
|||||||||
Net (decrease)/increase in cash and cash equivalents |
(1,545,857 | ) | 323,905 | |||||||||
Cash and cash equivalents at the beginning of the year |
8 | 3,736,229 | 6,458,139 | |||||||||
Effects of exchange rate changes on cash and cash equivalents |
(35,271 | ) | (8,804 | ) | ||||||||
|
|
|
|
|||||||||
Cash and cash equivalents at end of period |
2,155,101 | 6,773,240 | ||||||||||
|
|
|
|
Reconciliation of movement in liabilities whose cash flows are recorded in financing activities is included in note 8.
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
* |
Consideration for acquisition of subsidiaries in the business combination was entirely the form of issued shares |
F-197
Notes to the Unaudited Condensed Consolidated Financial Statements
1. |
Basis of preparation |
The unaudited condensed consolidated interim financial statements for the half year reporting periods ended June 30, 2020 and 2019 have been prepared in accordance with IAS 34 Interim Financial Reporting.
These unaudited condensed consolidated interim financial statements do not include all disclosure notes that would normally be included in an annual financial report. Accordingly, this report should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2019.
The accounting policies applied in these unaudited condensed consolidated interim financial statements are consistent with those of the previous financial year, except for the estimation of income tax and government grant income (see note 1.2 and 1.3).
The financial information for the year ended December 31, 2018 in the statement of comprehensive loss was presented by nature. The interim financial information for the periods ended June 30, 2020 and June 30, 2019 in the statement of comprehensive loss is presented by function to align to the presentation in the consolidated financial statements for the year ended December 31, 2019.
These unaudited condensed consolidated interim financial statements were authorized for issue by the Board of Directors on August 28, 2020.
Going concern
As of August 28, 2020, the date of approval of the unaudited consolidated financial statements for the period ended June 30, 2020, the company does not expect its cash deposits will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months. These conditions raise substantial doubt about the companys ability to continue as a going concern.
The company expects to seek equity financing from existing and new investors in conjunction with the contemplated Share Exchange Agreement entered into on July 29, 2020 between F-star Therapeutics Limited and Spring Bank Pharmaceuticals Inc. The closing of the Share Exchange Agreement would provide access to the existing cash deposits of Spring Bank Pharmaceuticals Inc as well as expected additional equity financing to be raised by F-star Therapeutics Limited as part of the Exchange. The estimated closing is anticipated in Q4 2020. The closing of the Share Exchange Agreement is however subject to approval by the shareholders of Spring Bank Pharmaceuticals Inc. If the merger is unsuccessful, the company will seek additional funding through equity financing from existing shareholders, or other alternative sources, which the directors believe can be obtained. Accordingly, the directors believe it is appropriate to continue to adopt the going concern basis of accounting. The financial statements do not include any adjustments that would be necessary if the group and company were unable to continue as a going concern.
1.1 |
New standards, amendments and IFRIC interpretations |
New standards, amendments and interpretations adopted by the group
The group has adopted all relevant IFRSs that were effective for periods beginning January 1, 2020. There was no change to any accounting policy or retrospective adjustments necessary.
1.2 |
Income tax benefit |
Income tax expense is recognized based on managements estimate of the weighted average effective annual income tax rate expected for the full financial year.
1.3 |
Government grants |
Income from government grants under the Coronavirus Job Retention Scheme (CJRS) is recognized over the period in which the related costs are recognized when the conditions for receiving the grant are met and the income becomes probable. The grant is presented within other income in the unaudited condensed consolidated statement of comprehensive loss.
F-198
Notes to the Unaudited Condensed Consolidated Financial Statements
2. |
Critical accounting estimates and judgments |
2.1 |
Fair value of financial instruments |
The group has unlisted investments and convertible notes measured at fair value with level 3 inputs as at June 30, 2020 and December 31, 2019.
The different levels have been defined as follows:
|
Quoted prices (unadjusted) in active markets for identical assets or liabilities (Level 1) |
|
Inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) (Level 2) |
|
Inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs) (Level 3) |
The groups finance team performs valuations of financial items for financial reporting purposes, including Level 3 fair values, in consultation with third party valuation specialists for complex valuations. Valuation techniques are selected based on the characteristics of each instrument, with the overall objective of maximizing the use of market-based information. The finance team reports directly to the chief financial officer (CFO) and any significant fair value changes at each reporting date are discussed with the CFO.
Unlisted investments key estimates
The fair value of this investment was determined based on a review of recent historical financial information against expected performance and information obtained from the investees management on potential sources of future revenue and value generation. Note 7 reconciles the fair value at June 30, 2020 to December 31, 2019 for unlisted investments held by the group. There were no significant movements in the inputs into the fair value assessment and management concluded that any movement in the fair value of these investments at June 30, 2020 would be insignificant.
Convertible loan notes
Note 8 shows the movements in fair value from December 31, 2019 to June 30, 2020 of the convertible loan notes held by the group. The key estimate used in the calculation of fair value of the notes is the weighted average probability of a range of possible fundraising events that would determine the conversion price of the notes and value of the embedded derivative. The weighted average probability of the possible fundraising scenarios have changed significantly since December 31, 2019. At December 31, 2019 the most likely scenario (90% probability) was a Series B fundraising round, whereas at June 30, 2020 the most likely conversion event was deemed to be notice issued by the noteholders and conversion of the notes to shares at the base price of $60M in total.
The fair value of the embedded derivative if the key assumption were to change by 10% whilst all other assumptions remain constant would be as follows:
Increase probability by 10%: |
£ | 402,653 | ||
Decrease probability by 10%: |
£ | (402,653 | ) |
2.2 |
Intangible asset impairment review |
Since December 31, 2019 there have been no indicators of impairment for any of the groups intangible assets and no significant movements in level 3 inputs used to assess the value in use and fair value less cost of disposal. As a result of the impairment reviews carried out at June 30, 2020 management concluded that none of the groups intangible assets required impairment.
F-199
Notes to the Unaudited Condensed Consolidated Financial Statements
3 |
Revenue |
The group derives revenue from the transfer of goods and services in the following categories:
6 months ended | ||||||||
Provision of R&D services & licensing income |
June 30, 2020 £ |
June 30, 2019 £ |
||||||
Europe |
949,955 | 18,874,427 | ||||||
U.S. |
587,485 | 1,279,371 | ||||||
|
|
|
|
|||||
Total |
1,537,440 | 20,153,798 | ||||||
|
|
|
|
|||||
Timing of recognition: |
||||||||
At a point in time |
| 9,785,951 | ||||||
Over time |
1,537,440 | 10,367,847 | ||||||
|
|
|
|
|||||
Total |
1,537,440 | 20,153,798 | ||||||
|
|
|
|
3.1 |
Assets and liabilities related to contracts with customers |
The group has recognized the following assets and liabilities related to contracts with customers:
June 30, 2020 £ |
December 31, 2019 £ |
|||||||
Deferred revenue related to upfront licensing fee, milestone income and R&D services income |
321,243 | 339,558 | ||||||
|
|
|
|
3.2 |
Revenue recognized in relation to contract liabilities |
Group deferred revenue related to upfront licensing fee, milestone income and R&D services income:
June 30, 2020 £ |
December 31, 2019 £ |
|||||||
Contract liabilities as of January 1/July 1 |
339,558 | 531,401 | ||||||
Additional amounts deferred in the period |
149,766 | | ||||||
Revenue recognized in the period included in opening contract liability |
(168,081 | ) | (191,843 | ) | ||||
|
|
|
|
|||||
Contract liabilities as of June 30/ December 31 |
321,243 | 339,558 | ||||||
|
|
|
|
Revenue recognized in the six-month period ended June 30, 2020 not included in the opening contract liability is £1.4 million (six-month period ended December 31, 2019: £1.5 million).
3.3 |
Unsatisfied long-term intellectual property licensing contract |
The following table shows the aggregate transaction price allocated to the remaining incomplete performance obligations.
June 30, 2020 £ |
December 31, 2019 £ |
|||||||
Transaction price allocated to outstanding performance obligations |
1,971,249 | 3,185,408 | ||||||
|
|
|
|
At the date of the statement of financial position of the remaining transaction price allocated to outstanding performance obligations, 96% was expected to be recognized during the second half of 2020 and 4% during 2021. At the reporting date, all performance obligations were expected to be satisfied by February 2021. However, the impact of the COVID-19 pandemic that occurred in March 2020 on expected timelines is not currently known (note 13).
F-200
Notes to the Unaudited Condensed Consolidated Financial Statements
4 |
Costs related to collaborative arrangements |
6 months
June 30, 2020 £ |
6 months
June 30, 2019 £ |
|||||||
Derecognition of intangible asset |
| 12,574,093 | ||||||
Amortization |
169,427 | 476,429 | ||||||
Direct labor cost |
119,697 | 1,928,920 | ||||||
External R&D costs |
43,680 | 2,457,514 | ||||||
|
|
|
|
|||||
332,804 | 17,436,956 | |||||||
|
|
|
|
5 |
Other Income |
6 months ended | ||||||||
June 30, 2020 £ |
June 30, 2019 £ |
|||||||
Government grants |
371,115 | | ||||||
|
|
|
|
|||||
371,115 | |
On March 11, 2020 the World Health Organization declared the novel strain of coronavirus (COVID-19) a global pandemic and recommended containment and mitigation measures worldwide. Management took the decision in April 2020 to furlough a significant proportion of the R&D workforce, and took advantage of the UK Government Coronavirus Job Retention Scheme (CJRS) that provided funding to businesses with furloughed staff. The grant funding available in the period ended June 30, 2020 covered 80% of furloughed employees wages plus employer National Insurance and pension contributions up to a maximum of £2,500 per month per furloughed employee. All of the government grant income stated in the table above relates to claims under the CJRS scheme in the period.
6 |
Profit and loss information |
(Loss)/profit for the half year is stated after charging:
6 months ended | ||||||||
June 30, 2020 £ |
June 30, 2019 £ |
|||||||
Charged to research and development costs: |
||||||||
Depreciation of property, plant and equipment |
225,358 | 78,757 | ||||||
Amortization of intangible assets |
606,822 | 290,407 | ||||||
Impairment of intangible assets |
| 1,800,684 | ||||||
Charged to general and administrative costs: |
||||||||
Depreciation of property, plant and equipment (including right of use assets) |
244,843 | 86,153 | ||||||
Loss on disposal of tangible fixed assets |
5,625 | |
7. |
Financial assets at fair value through profit or loss |
The group has not elected to recognize fair value gains and losses through other comprehensive income for the following equity investments:
June 30, 2020 £ |
December 31, 2019 £ |
|||||||
Balance January 1/ July 1 |
42,662 | 44,808 | ||||||
Foreign currency translation |
3,050 | (2,146 | ) | |||||
|
|
|
|
|||||
Balance June 30/ December 31 |
45,712 | 42,662 | ||||||
|
|
|
|
F-201
Notes to the Unaudited Condensed Consolidated Financial Statements
Amounts recognized in profit and loss
During the six-month period ended June 30, 2020, a gain of £3,050 (six-month period ended December 31, 2019: loss of £2,146) was recognized in the unaudited condensed consolidated statements of comprehensive income within other expenses.
8. |
Cash and cash equivalents |
June 30, 2020 £ |
December 31, 2019 £ |
|||||||
Cash at bank and in hand |
2,155,101 | 3,736,229 | ||||||
|
|
|
|
|||||
Balances per statement of cash flows |
2,155,101 | 3,736,229 | ||||||
|
|
|
|
Cash and cash equivalents are held at amortized cost with fair value approximating to carrying value.
Reconciliation of movement in liabilities from financing activities
Lease
£ |
Borrowings £ |
Total £ |
||||||||||
At 1 January 2019 |
| | | |||||||||
Cash flows |
(88,871 | ) | | (88,871 | ) | |||||||
Non-cash changes |
||||||||||||
Acquired with subsidiary |
800,898 | | 800,898 | |||||||||
Interest charged |
5,497 | | 5,497 | |||||||||
|
|
|
|
|
|
|||||||
At June 30, 2019 |
717,524 | | 717,524 | |||||||||
|
|
|
|
|
|
|||||||
At January 1, 2020 |
504,805 | 11,364,454 | 11,869,259 | |||||||||
Cash flows |
(231,249 | ) | 405,357 | 174,108 | ||||||||
Non-cash changes |
||||||||||||
Interest charged |
9,885 | 427,663 | 437,548 | |||||||||
Fair value adjustment on borrowings |
| 1,508,796 | 1,508,796 | |||||||||
Foreign exchange differences |
| 698,487 | 698,487 | |||||||||
Termination of lease |
(40,545 | ) | | (40,545 | ) | |||||||
|
|
|
|
|
|
|||||||
At June 30, 2020 |
242,896 | 14,404,757 | 14,647,653 | |||||||||
|
|
|
|
|
|
9. |
Loans and borrowings |
June 30, 2020 £ |
December 31, 2019 £ |
|||||||
Current |
||||||||
Lease liability |
242,896 | 465,060 | ||||||
Convertible notes held at FVTPL (unsecured) |
14,404,757 | 11,364,454 | ||||||
|
|
|
|
|||||
14,647,653 | 11,829,514 | |||||||
|
|
|
|
|||||
Non-current |
||||||||
Lease liability |
| 39,745 | ||||||
|
|
|
|
|||||
| 39,745 | |||||||
|
|
|
|
|||||
Total |
14,647,653 | 11,869,259 | ||||||
|
|
|
|
All of the groups lease liabilities arise from the leasing of office buildings.
F-star Therapeutics Limited issued USD denominated, 8% convertible notes on September 19, 2019 for USD $6.6 million (£4.9 million) and a second tranche of convertible notes was issued on November 27, 2019 for USD
F-202
Notes to the Unaudited Condensed Consolidated Financial Statements
$6.6 million (£5.1 million) under the same terms. On March 26, 2020, a third tranche was issued at $0.5 million (£0.4 million), under the same terms.
The notes are convertible into a variable number of series A preference shares at the option of the holder. On expiry of the term, if no conversion notice has been issued 30 business days prior to expiry date (September 18, 2020), the notes shall be redeemable at principal plus accrued interest. Notes, together with interest outstanding, shall automatically convert into series A preference shares in the event F-star Therapeutics Limited raises at least USD $50 million or there is a change of control.
Unless the notes are convertible upon expiry of the term, the conversion rate for each note held plus accrued interest, is the lesser of: 1.25 shares based on the market price per share on the conversion date, or USD $100 million divided by the number of shares in issue plus the number of shares capable of being issued. Upon expiry of the term, the notes are converted at a rate of USD $60 million divided by the number of shares in issue plus the number of shares capable of being issued.
The convertible notes are presented in the statement of financial position as follows:
June 30, 2020 £ |
December 31, 2019 £ |
|||||||
Value of the notes issued |
10,457,320 | 10,051,963 | ||||||
Cumulative fair value adjustment through profit and loss |
2,615,109 | 1,106,313 | ||||||
Interest charged |
582,154 | 154,491 | ||||||
Foreign exchange loss on revaluation |
750,174 | 51,687 | ||||||
|
|
|
|
|||||
Current liability |
14,404,757 | 11,364,454 | ||||||
|
|
|
|
The fair value of the convertible notes was measured using level 3 inputs (see note 2).
The following table presents the changes in level 3 items for the 30 June 2020 (2019: no convertible notes were held in the comparative period).
Convertible
£ |
||||
Balance at January 1, 2020 |
1,106,313 | |||
Loss recognized in consolidated statement of comprehensive loss |
1,508,796 | |||
|
|
|||
Balance at June 30, 2020 |
2,615,109 | |||
|
|
The fair value is materially different from the value of convertible notes if they were held at amortized cost as at June 30, 2010 and December 31, 2019:
2020 Fair value £ |
2020 Amortized cost £ |
2019 Fair value £ |
2019 Amortized cost £ |
|||||||||||||
Convertible notes |
14,404,757 | 11,789,648 | 11,364,454 | 10,258,141 | ||||||||||||
|
|
|
|
|
|
|
|
The difference between the carrying value of the convertible notes and the amount that the entity would be contractually required to repay at maturity of £11,566,471 to the holders of the obligation is £2,838,286.
10. |
Share-based payments |
The groups 2019 Equity Incentive Plan (the 2019 Plan) was established for granting share options to directors, officers, employees and consultants to the Group.
F-203
Notes to the Unaudited Condensed Consolidated Financial Statements
New share options issued in the half year
A reconciliation of the movement in share options during the half-year ended June 30, 2020 and June 30 2019 is shown below:
2020 Number |
2020
Weighted
price |
2019 Number |
2019
Weighted
exercise price |
|||||||||||||
Outstanding at January 1 |
2,304,706 | £ | 0.47 | | | |||||||||||
Granted in the period |
215,144 | £ | 0.03 | 2,327,736 | £ | 0.60 | ||||||||||
Exercised in the period |
(34,133 | ) | £ | 0.01 | | | ||||||||||
Forfeited in the period |
(162,083 | ) | £ | 0.65 | | | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Outstanding at June 30 |
2,323,634 | £ | 0.58 | 2,327,736 | £ | 0.60 | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Exercisable at June 30 |
1,627,483 | £ | 0.60 | 374,612 | £ | 0.01 | ||||||||||
|
|
|
|
|
|
|
|
Options granted in the six months ended June 30, 2020 vest over a four-year period with 25% vesting after the first anniversary from the date of the grant and the balance vesting monthly over the remaining three years. Options granted in the six months ended June 30, 2019 vest over a four-year period with 28% vesting after the first anniversary from the date of the grant and the balance vesting monthly over the remaining three years. For certain senior members of management and directors, the board of directors has approved an alternative vesting schedule.
Share options outstanding at June 30, 2020 have the following expiry dates and exercise prices:
Grant date | Expiry date |
Remaining
(months) |
Exercise price |
2020 Number |
||||||||
June 14, 2019 |
June 14, 2029 |
108 | £0.00£0.05 | 350,118 | ||||||||
June 14, 2019 |
June 14, 2029 |
108 | $1.87 | 869,205 | ||||||||
June 14, 2019 |
June 14, 2029 |
108 | £0.01 | 818,317 | ||||||||
July 1, 2019 |
July 1, 2029 |
108 | £0.01 | 850 | ||||||||
December 18, 2019 |
December 18, 2029 |
114 | $1.61 | 35,000 | ||||||||
December 18, 2019 |
December 18, 2029 |
114 | £0.01 | 35,000 | ||||||||
April 14, 2020 |
April 14, 2030 |
118 | £0.01 | 117,344 | ||||||||
June 23, 2020 |
June 23, 2030 |
120 | £0.01 | 94,500 | ||||||||
June 23, 2020 |
June 23, 2030 |
120 | $1.39 | 3,300 | ||||||||
|
|
|||||||||||
2,323,634 | ||||||||||||
|
|
The total number of share options available to issue at June 30, 2020 and at June 30, 2019 was 2,477,736 and 2,327,736 respectively.
Share option valuation (equity-settled)
The assumptions used in the black-scholes option pricing model to determine the fair value of the share options granted to employees and directors during the year ended December 31, 2019 were as follows:
June 23,
(US Grants) |
June 23,
(UK Grants) |
April 14,
(UK grants) |
June 14,
(US grants) |
June 14,
(UK grants) |
||||||||||||||||
Share price at grant date |
£ | 1.38 | £ | 1.38 | £ | 1.38 | £ | 2.45 | £ | 2.45 | ||||||||||
Exercise price |
£ | 1.12 | £ | 0.01 | £ | 0.01 | £ | 1.47 | £ | 0.01 | ||||||||||
Term (years) |
5.054 | 5.054 | 5.054 | 5.054 | 5.054 | |||||||||||||||
Expected volatility |
98.30 | % | 98.30 | % | 98.30 | % | 70.03 | % | 70.03 | % | ||||||||||
Expected dividends expressed as a dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % | ||||||||||
Risk-free rate |
0.33 | % | 0.00 | % | 0.17 | % | 1.85 | % | 1.85 | % | ||||||||||
Fair value per option |
£ | 1.0588 | £ | 1.3812 | £ | 1.3770 | £ | 1.7057 | £ | 2.4590 |
F-204
Notes to the Unaudited Condensed Consolidated Financial Statements
The expected volatility is based on the estimate of the average of the volatility of peer companies in the biotechnology sector. The term is the average expected period from grant to exercise. The determination of the appropriate risk-free rate is based upon the Federal Reserve market yield on U.S. Treasury Securities at 5-year constant maturity for US grants and the 5-year Gilt bond yield for UK grants, on Investment basis.
Share-based compensation charge
The group recorded share-based compensation expense for the six months ended June 30, 2020 and June 30, 2019 as follows:
2020 £ |
2019 £ |
|||||||
Cancelled options |
| 24,307 | ||||||
Modified options |
15,718 | 7,977 | ||||||
New options with alternative vesting schedule |
128,953 | 333,688 | ||||||
New options with standard vesting |
714,652 | 652,840 | ||||||
|
|
|
|
|||||
859,323 | 1,018,812 | |||||||
|
|
|
|
As of June 30, 2020, and June 20, 2019, there was £1,223,596 and £3,118,367 of unrecognized compensation cost related to outstanding but unvested share options respectively, which are expected to be recognized over a weighted-average period of 2.91 years and 3.52 years.
The total share-based compensation expense for the six months ended June 30, 2020 and June 30, 2019 is recorded within the unaudited condensed consolidated financial statements of the group as follows:
2020 £ |
2019 £ |
|||||||
Research and development |
169,341 | 80,203 | ||||||
General and administration |
689,982 | 938,609 | ||||||
|
|
|
|
|||||
Total recognized in consolidated statement of comprehensive loss |
859,323 | 1,018,812 | ||||||
|
|
|
|
11. |
Commitments |
The group has contracted commitments with a contract manufacturing organization (CMO) as of June 30, 2020 amounting to £224,953 and as of December 31, 2019 amounting to £734,734 for activities that are ongoing or are scheduled to start within 3 to 9 months of the date of the statement of financial position. Under the terms of the agreement with the CMO, the group is committed to pay for some activities if they are cancelled up to 3 to 9 months prior to the start date of the activity.
During the six months ended June 30, 2020 the group entered into two agreements with strategic advisors to assist with potential program partnering and fundraising activities. These agreements include success-based fees which management have assessed as possible, but not probable, as of the reporting date. It is difficult to estimate the magnitude of these fees, if any, as they are dependent upon the value of future investments.
The Company has no significant capital expenditure contracted for, but not recognized as a liability at June 30, 2020 or December 31, 2019.
12. |
Related parties |
The group has not recorded any related party transactions in the six months ended June 30, 2020 other than remuneration payments to key management personnel. In the six months ended June 30, 2019, prior to the capital reorganization, business combination and asset acquisition that resulted in the formation of the group, there were transactions between the accounting acquirer, F-star Delta Limited, and other entities that also became legal
F-205
Notes to the Unaudited Condensed Consolidated Financial Statements
subsidiaries of the ultimate parent entity, F-star Therapeutics Limited. These entities were related parties to F-star Delta Limited prior to the date of the group formation (May 7, 2019) by virtue of common directorships.
R&D
6 months
June 30, 2019 £ |
Other
6 months
June 30, 2019 £ |
|||||||
Expenses recharged from: |
||||||||
F-star Beta Limited |
1,863,660 | 483,653 | ||||||
F-star Biotechnology Limited |
206,221 | | ||||||
F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H |
| 11,536 |
On February 28, 2019, the group entered into a sub-lease rental arrangement with US-based company, Triplet Therapeutics, Inc. N. Bermingham who is a non-executive director of the group serves as the Chief Executive Officer of Triplet Therapeutics, Inc. The lease was terminated with effect from December 31, 2019. The group no longer acts as a lessor from this date and there are no material ongoing commitments with respect to this lease. Income from Triplet Therapeutics totaled £nil in the six-month period ended June 30, 2020 (six-month period ended June 30, 2019: £13,651). As at June 30, 2020, amounts receivable included in trade and other receivables was £nil (December 31, 2019: £4,588).
13. |
Subsequent events |
On July 15, 2020, a deed of amendment was enacted in respect of the May 14, 2019 License and Collaboration agreement between the group and Ares Trading S.A. The amendment had two main purposes (i) to allow Ares to exercise its option early to acquire intellectual property rights to the second molecule included in the agreement; and (ii) to grant additional options to acquire intellectual property rights for a further two molecules. As a result of this amendment all performance obligations under the May 13, 2019 agreement in respect of the second molecule were deemed to have been fully satisfied at July 15, 2020 and the group derecognized the associated intangible asset. The option fee of £6.7 million (7.5 million) was recognized at a point in time and the carrying value of the intangible asset prior to disposal was £6.2 million.
As a result of this amendment, the maximum amount payable by Ares Trading S.A on the achievement of certain development and regulatory milestones in the aggregate is increased to £348.8 million (408.5 million), and the maximum amount payable on the achievement of certain commercial milestones is increased to £215.2 million (252 million).
On July 14, 2020 the convertible notes were modified by extending the expiry date from September 19, 2020 to January 31, 2021.
On March 11, 2020 the World Health Organization declared the novel strain of coronavirus (COVID-19) a global pandemic and recommended containment and mitigation measures worldwide. At June 30, 2020 management reviewed the impact of the pandemic to date, in particular in relation to the following areas:
|
inputs into the cost-to-cost method for revenue recognition; and |
|
assessment of impairment of the carrying value of intangible assets. |
At the date of issuance there were no significant impacts identified by management, but management cannot reasonably estimate the length or severity of the pandemic or the extent to which the disruption may materially impact the business in future. At this point it is not clear whether any project delays can be mitigated in the second half of 2020. Any adverse impact on operations, business or financial outlook could be material and management continues to closely monitor the situation.
On July 29, 2020, F-star entered into a share exchange agreement with Spring Bank Pharmaceuticals Inc (Spring Bank), a NASDAQ- listed, clinical-stage biopharmaceutical company. Pursuant to the share exchange
F-206
Notes to the Unaudited Condensed Consolidated Financial Statements
agreement, Spring Bank will acquire the entire issued share capital of F-star in exchange for newly issued shares of Spring Bank common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the required approval of Spring Bank stockholders.
Spring Bank shareholders will have the opportunity to obtain potential future value in the form of two Contingent Value Rights (CVR) associated with Spring Banks SB 11285 IV clinical program and a STING antagonist research and development program. Subject to the terms of the first CVR agreement for the STING agonist clinical program, if one or more strategic transactions are consummated for SB 11285 by the combined company during a period that is the longer of one and a half years following the closing of the combination or one year after the final database lock of the current SB 11285 IV Phase 1a/1b trial, those equity holders of Spring Bank will receive the greater of 25% of the net proceeds from such transactions or $1.00 per share (on a pre-reverse split basis), provided that the aggregate net proceeds are at least approximately $18.0 million. Subject to the terms of the second CVR agreement, if a potential development agreement is consummated and one or more strategic transactions are consummated for the STING antagonist research platform by the combined company during the seven (7)-year period following the closing of the combination, those equity holders of Spring Bank will receive 80% of the net proceeds from such transactions. If Spring Bank enters into a development agreement for the STING antagonist research platform in advance of the closing of the proposed combination, Spring Bank may include certain proceeds from such transaction in its net cash calculation.
14. |
Loss per share |
6 months ended | ||||||||
June 30, 2020 £ |
June 30, 2019 £ |
|||||||
Loss per share attributable to ordinary shares for the period: |
||||||||
basic and diluted |
(0.64 | ) | (0.86 | ) | ||||
2020 Number |
2019 Number |
|||||||
Weighted average number of ordinary shares for basic and diluted losses per share |
16,243,171 | 11,224,160 |
The impact of the convertible debt and share options in the six-month periods ended June 30, 2020 (296,360 shares) and 2019 (693,507 shares) is antidilutive.
The calculations of basic and diluted loss per share are based on the net loss attributable to ordinary equity shareholders of F-star Therapeutics Limited for the period ended June 30, 2020 of £10,351,409 (2019: 9,702,401). Basic loss per share amounts are calculated by dividing the net loss attributable to equity holders of the parent by the weighted average number of the parents issued ordinary shares outstanding during the period.
The group incurred a loss for the periods ended June 30, 2020 and 2019 and as a result, the dilutive potential ordinary shares had a non-dilutive impact on loss per share. As such the diluted loss per share is reported to be the same as basic loss per share.
F-207
TABLE OF CONTENTS
ARTICLE 1 THE ACQUISITION |
A-2 | |||||
1.1 |
The Acquisition |
A-2 | ||||
1.2 |
Closing |
A-2 | ||||
1.3 |
Company Name Change |
A-2 | ||||
1.4 |
F-Star Securities |
A-2 | ||||
1.5 |
Calculation of Net Cash |
A-3 | ||||
1.6 |
F-Star Loan Notes |
A-4 | ||||
1.7 |
Contingent Value Rights |
A-5 | ||||
1.8 |
Preliminary Consents and Associated Acknowledgments of Sellers |
A-5 | ||||
1.9 |
Delivery of Acquisition Consideration |
A-6 | ||||
1.10 |
Power of Attorney |
A-7 | ||||
1.11 |
No Further Rights |
A-7 | ||||
1.12 |
Additional Actions |
A-7 | ||||
ARTICLE 2 REPRESENTATIONS AND WARRANTIES OF F-STAR |
A-8 | |||||
2.1 |
Organization and Qualification; Charter Documents |
A-8 | ||||
2.2 |
Capital Structure |
A-8 | ||||
2.3 |
Authority; Non-Contravention; Approvals |
A-10 | ||||
2.4 |
F-Star Financial Statements; No Undisclosed Liabilities |
A-11 | ||||
2.5 |
Absence of Certain Changes or Events |
A-12 | ||||
2.6 |
Taxes |
A-12 | ||||
2.7 |
Intellectual Property |
A-13 | ||||
2.8 |
Compliance with Legal Requirements |
A-15 | ||||
2.9 |
Legal Proceedings; Orders |
A-17 | ||||
2.10 |
Brokers and Finders Fees |
A-18 | ||||
2.11 |
Employee Benefit Plans |
A-18 | ||||
2.12 |
Title to Assets; Real Property |
A-19 | ||||
2.13 |
Environmental Matters |
A-19 | ||||
2.14 |
Labor Matters |
A-20 | ||||
2.15 |
F-Star Contracts |
A-20 | ||||
2.16 |
Books and Records |
A-21 | ||||
2.17 |
Insurance |
A-21 | ||||
2.18 |
Government Contracts |
A-22 | ||||
2.19 |
Interested Party Transactions |
A-22 | ||||
2.20 |
Disclosure; Company Information |
A-22 | ||||
2.21 |
Anti-Takeover Statutes Not Applicable |
A-22 | ||||
2.22 |
Ownership of Company Capital Stock |
A-22 | ||||
2.23 |
F-Star Pre-Closing Financing |
A-22 | ||||
2.24 |
Exclusivity of Representations; Reliance |
A-23 | ||||
ARTICLE 3 REPRESENTATIONS AND WARRANTIES OF COMPANY |
A-23 | |||||
3.1 |
Organization and Qualification; Charter Documents |
A-24 | ||||
3.2 |
Capital Structure |
A-24 | ||||
3.3 |
Authority; Non-Contravention; Approvals |
A-25 | ||||
3.4 |
Anti-Takeover Statutes Not Applicable |
A-26 | ||||
3.5 |
SEC Filings; Company Financial Statements; No Undisclosed Liabilities |
A-26 | ||||
3.6 |
Absence of Certain Changes or Events |
A-27 | ||||
3.7 |
Taxes |
A-27 | ||||
3.8 |
Intellectual Property |
A-28 | ||||
3.9 |
Compliance with Legal Requirements |
A-30 | ||||
3.10 |
Legal Proceedings; Orders |
A-32 | ||||
3.11 |
Brokers and Finders Fees |
A-33 |
A-i
3.12 |
Employee Benefit Plans |
A-33 | ||||
3.13 |
Title to Assets; Real Property |
A-34 | ||||
3.14 |
Environmental Matters |
A-34 | ||||
3.15 |
Labor Matters |
A-35 | ||||
3.16 |
Company Contracts |
A-35 | ||||
3.17 |
Books and Records |
A-37 | ||||
3.18 |
Insurance |
A-37 | ||||
3.19 |
Code of Ethics |
A-37 | ||||
3.20 |
Opinion of Financial Advisor |
A-37 | ||||
3.21 |
Shell Company Status |
A-37 | ||||
3.22 |
Government Contracts |
A-37 | ||||
3.23 |
Interested Party Transactions |
A-37 | ||||
3.24 |
Bank Accounts; Deposits |
A-37 | ||||
3.25 |
Disclosure; Company Information |
A-38 | ||||
3.26 |
Exclusivity of Representations; Reliance |
A-38 | ||||
ARTICLE 4 REPRESENTATIONS AND WARRANTIES OF SELLERS |
A-38 | |||||
4.1 |
Ownership of F-Star Share Capital and Loan Notes |
A-38 | ||||
4.2 |
Authority; Non-Contravention |
A-39 | ||||
4.3 |
Tax Matters |
A-39 | ||||
4.4 |
Disclosure; Seller Information |
A-39 | ||||
4.5 |
Ownership of Company Capital Stock; Affiliates |
A-39 | ||||
4.6 |
Exclusivity of Representations; Reliance |
A-40 | ||||
ARTICLE 5 CONDUCT OF BUSINESS PENDING THE CLOSING |
A-40 | |||||
5.1 |
Conduct of Company Business |
A-40 | ||||
5.2 |
Conduct of F-Star Business |
A-43 | ||||
ARTICLE 6 ADDITIONAL AGREEMENTS |
A-45 | |||||
6.1 |
Registration Statement; Proxy Statement |
A-45 | ||||
6.2 |
Company Stockholders Meeting |
A-46 | ||||
6.3 |
Access to Information; Confidentiality |
A-47 | ||||
6.4 |
Regulatory Approvals and Related Matters |
A-48 | ||||
6.5 |
Director Indemnification and Insurance |
A-48 | ||||
6.6 |
Notification of Certain Matters |
A-50 | ||||
6.7 |
Public Announcements |
A-50 | ||||
6.8 |
Conveyance Taxes |
A-51 | ||||
6.9 |
Board of Directors and Officers |
A-51 | ||||
6.10 |
Non-Solicitation by Company and F-Star |
A-51 | ||||
6.11 |
Restrictions on Transfer |
A-53 | ||||
6.12 |
Joinder Agreements; Seller Lock-Up Agreements |
A-53 | ||||
6.13 |
Listing; Symbol |
A-53 | ||||
6.14 |
Section 16 Compliance |
A-53 | ||||
6.15 |
F-Star Share Incentives |
A-54 | ||||
6.16 |
F-Star Replacement ESOP |
A-57 | ||||
6.17 |
Allocation Certificate |
A-58 | ||||
6.18 |
Employee Matters |
A-58 | ||||
6.19 |
Disclosure Schedules |
A-58 | ||||
6.20 |
Tax Matters |
A-58 | ||||
6.21 |
Legends |
A-58 | ||||
6.22 |
Permitted Dispositions; Approved Development Transaction |
A-59 | ||||
6.23 |
Company Reverse Stock Split |
A-59 | ||||
6.24 |
Company Options and Company RSUs |
A-59 | ||||
6.25 |
Stockholder Litigation |
A-60 | ||||
6.26 |
Termination of Contracts |
A-60 |
A-ii
6.27 |
Company Lease Obligations |
A-60 | ||||
6.28 |
F-Star Financials |
A-60 | ||||
6.29 |
Articles of Association |
A-60 | ||||
6.30 |
Equity Commitment Exchange |
A-60 | ||||
6.31 |
F-Star Pre-Closing Financing |
A-60 | ||||
ARTICLE 7 CONDITIONS TO THE CLOSING |
A-60 | |||||
7.1 |
Conditions to Obligation of Each Party to Effect the Acquisition |
A-60 | ||||
7.2 |
Additional Conditions to Obligations of F-Star and Sellers |
A-61 | ||||
7.3 |
Additional Conditions to Obligations of Company |
A-62 | ||||
ARTICLE 8 TERMINATION |
A-63 | |||||
8.1 |
Termination |
A-63 | ||||
8.2 |
Effect of Termination |
A-64 | ||||
8.3 |
Expenses; Termination Fees |
A-65 | ||||
ARTICLE 9 GENERAL PROVISIONS |
A-66 | |||||
9.1 |
Notices |
A-66 | ||||
9.2 |
Amendment |
A-67 | ||||
9.3 |
Headings |
A-67 | ||||
9.4 |
Severability |
A-67 | ||||
9.5 |
Entire Agreement |
A-67 | ||||
9.6 |
Successors and Assigns |
A-67 | ||||
9.7 |
Parties in Interest |
|
A-67
|
|
||
9.8 |
Waiver |
A-67 | ||||
9.9 |
Remedies Cumulative; Specific Performance |
A-68 | ||||
9.10 |
Governing Law; Venue; Waiver of Jury Trial |
A-68 | ||||
9.11 |
Counterparts and Exchanges by Electronic Transmission or Facsimile |
A-68 | ||||
9.12 |
Attorney Fees |
A-68 | ||||
9.13 |
Cooperation |
A-68 | ||||
9.14 |
Limited Survival of Representations and Warranties |
A-69 | ||||
9.15 |
Construction |
A-69 |
Exhibits
Exhibit A | Certain Definitions | |
Exhibit B | Form of Company Lock-up Agreement | |
Exhibit C | Form of Seller Lock-up Agreement | |
Exhibit D | Form of Company Voting Agreement | |
Exhibit E-1 | Form of STING Agonist CVR Agreement | |
Exhibit E-2 | Form of STING Antagonist CVR Agreement | |
Exhibit F | Form of Deed of Termination Shareholders Agreement | |
Exhibit G | Form of Joinder Agreement | |
Exhibit H | Sample Net Cash Calculation | |
Exhibit I | Closing Articles of Association | |
Exhibit J | Sample Exchange Ratio Calculation |
A-iii
Schedules
Schedule I |
Sellers |
|
Schedule II |
Company Lock-up Agreement Parties |
|
Schedule III-A |
Seller Lock-up Agreement Parties |
|
Schedule III-B |
Additional Seller Lock-up Agreement Parties |
|
Schedule IV |
Company Voting Agreement Parties |
|
Schedule V |
F-Star Pre-Closing Financing Subscription Amounts |
|
Schedule VI |
Company Director and Officer Resignations |
|
Schedule 5.1 |
Conduct of Company Business |
|
Schedule 5.1(t) |
Vendors |
|
Schedule 5.2 |
Conduct of F-Star Business |
|
Schedule 6.9 |
Director and Officer Appointees |
|
Schedule 6.26 |
Termination of Contracts |
Company Disclosure Schedule
F-Star Disclosure Schedule
A-iv
SHARE EXCHANGE AGREEMENT
THIS SHARE EXCHANGE AGREEMENT is made and entered into as of July 29, 2020 (this Agreement) by and among Spring Bank Pharmaceuticals, Inc., a Delaware corporation (Company), F-Star Therapeutics Limited, a company registered in England and Wales with company number 11532458 (F-Star), and the Persons listed on Schedule I hereto (including each Person, if any, who executes a Joinder Agreement as contemplated by Sections 6.11 and 6.12) (Sellers). F-Star, Company and each Seller are each a Party and referred to collectively herein as the Parties. Certain capitalized terms used in this Agreement are defined in Exhibit A.
RECITALS
WHEREAS, Sellers own, as of the date hereof, all of the F-Star Issued Share Capital and the 2019 Loan Notes outstanding as of the date hereof that are convertible into shares in the capital of F-Star;
WHEREAS, Sellers desire to sell to Company, and Company desires to purchase from Sellers, all of the F-Star Shares in exchange for shares of Company Common Stock, with the result of F-Star becoming a wholly-owned Subsidiary of Company, in each case on the terms and conditions set forth herein;
WHEREAS, the board of directors of Company (i) has determined that this Agreement and the Contemplated Transactions to which the Company is or will be a party are fair to, and in the best interests of, Company and its stockholders, (ii) has approved, adopted and declared advisable this Agreement and the Contemplated Transactions to which the Company is or will be a party and (iii) has determined to recommend that the Company Stockholders vote to approve the Company Stockholder Approval Matters;
WHEREAS, after the Company Stockholder Approval, but prior to the Closing, (i) all of the issued F-Star Seed Preference Shares and F-Star Series A Preference Shares shall be converted (the Share Conversion) into F-Star Ordinary Shares and (ii) the 2019 Loan Notes shall be converted into F-Star Ordinary Shares pursuant to the 2019 Loan Note Conversion (collectively, the F-Star Conversion Shares);
WHEREAS, as a condition to the willingness of F-Star and Sellers to enter into this Agreement, contemporaneously with the execution and delivery of this Agreement, each of the Persons listed on Schedule II, and each Company Stockholder affiliated with any such Person, is entering into a lock-up agreement in substantially the form of Exhibit B attached hereto (the Company Lock-up Agreements) concurrently with the execution and delivery of this Agreement;
WHEREAS, as a condition to the willingness of Company to enter into this Agreement, contemporaneously with the execution and delivery of this Agreement, each of the Sellers listed on Schedule III-A is entering into a lock-up agreement in substantially the form of Exhibit C attached hereto (the Seller Lock-up Agreements) concurrently with the execution and delivery of this Agreement;
WHEREAS, as a condition to the willingness of F-Star and Sellers to enter into this Agreement, concurrently with the execution and delivery of this Agreement, each of the officers and directors of Company listed on Schedule IV is entering into a voting agreement in substantially the form of Exhibit D attached hereto (the Company Voting Agreement), in favor of F-Star and Sellers, pursuant to which such officers and directors have agreed, among other things, to vote their shares of Company Common Stock in favor of the Company Stockholder Approval Matters;
WHEREAS, immediately prior to the execution and delivery of this Agreement, and as a condition of the willingness of Company to enter into this Agreement, each Investor has executed an Equity Commitment Letter in the form of the document set out in the Forms Folder in the F-Star Data Room pursuant to which such Investor has agreed to enter into a Subscription Agreement in the form of the document set out in the Forms Folder in the F-Star Data Room to purchase F-Star Ordinary Shares prior to the Closing upon the terms and subject to the conditions set forth in the Subscription Agreement in connection with the F-Star Pre-Closing Financing; and
WHEREAS, one or more additional investors (each, an Additional Investor and collectively the Additional Investors) may after the date of this Agreement enter into one or more additional equity
A-1
commitments letters in the form of the Equity Commitment Letter (the Additional Equity Commitment Letters) pursuant to which such Additional Investors will also agree to enter into a Subscription Agreement in the form of the document set out in the Forms Folder in the F-Star Data Room to purchase F-Star Ordinary Shares prior to the Closing upon the terms and subject to the conditions set forth in the Subscription Agreement in connection with the F-Star Pre-Closing Financing.
AGREEMENT:
NOW, THEREFORE, in consideration of the foregoing and the representations, warranties and covenants herein contained, and for other good and valuable consideration, the receipt, adequacy and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
THE ACQUISITION
1.1 The Acquisition. Upon the terms and subject to the conditions of this Agreement, at the Closing, Sellers shall (on a several and not joint basis) sell, transfer and convey to Company, and Company shall purchase from Sellers, all of the F-Star Shares free from all Encumbrances. The F-Star Shares shall be sold with all rights attaching to them at Closing or subsequently, including the rights to receive all dividends and other distributions declared, made or paid on F-Star Shares after Closing. Company shall not be obliged to complete the purchase and sale of the F-Star Shares unless the purchase and sale of all the F-Star Shares is completed simultaneously. Each Seller hereby waives any rights of preemption or other restrictions on transfer in respect of the F-Star Shares, whether conferred by the Articles of Association, the Shareholders Agreement or otherwise, in respect of the transfers of the F-Star Shares contemplated by this Agreement and approves such transfer for the purposes of the Shareholders Agreement, Articles of Association or otherwise. The purchase and sale of the F-Star Shares pursuant to this Agreement is referred to herein as the Acquisition.
1.2 Closing. Unless this Agreement has been terminated and the Contemplated Transactions have been abandoned pursuant to Section 8.1, and subject to the satisfaction or waiver of the conditions set forth in Article 7, the consummation of the Acquisition (the Closing) will take place at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial Center, Boston, Massachusetts, as soon as possible (but in any event no later than two (2) Business Days) after satisfaction or waiver of the conditions set forth in Article 7 (other than those conditions that by their nature are to be satisfied at the Closing, but subject to the satisfaction or waiver of each such condition), or at such other time, date and place as F-Star and Company may mutually agree in writing. The date on which the Closing actually takes place is referred to as the Closing Date.
1.3 Company Name Change. Unless otherwise determined by F-Star, Company and F-Star will take any and all action necessary to change Companys name to F-Star Therapeutics, Inc. effective immediately following the Closing.
(a) F-Star Shares. Each F-Star Share in issue immediately prior to the Closing will be sold to Company by the Seller that owns such F-Star Share in consideration for such number of duly authorized, validly issued, fully paid and non-assessable shares of Company Common Stock as is equal to the Exchange Ratio, rounded to the nearest whole share of Company Common Stock (after aggregating all fractional shares of Company Common Stock issuable to such Seller) (the Acquisition Consideration).
(b) F-Star Options and F-Star RSUs. Each F-Star Option that is outstanding and unexercised immediately prior to the Closing and each F-Star RSU will be treated in accordance with Section 6.15.
(c) Adjustments to Exchange Ratio. The Exchange Ratio will be calculated in the manner described in the definition of Exchange Ratio on Exhibit A hereto and will be appropriately adjusted to reflect fully the effect of any stock split, reverse split (including the Company Reverse Stock Split to the extent such split has not previously been taken into account in calculating the Exchange Ratio), stock dividend (including any dividend or distribution of securities convertible into shares in the F-Star Share Capital or Company Common Stock),
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reorganization, recapitalization or other like change with respect to shares in the F-Star Share Capital or Company Common Stock occurring after the date hereof and prior to the Closing.
(d) No Fractional Shares. No fractional shares of Company Common Stock will be issued in connection with the Acquisition, and no certificates or scrip for any such fractional shares of Company Common Stock will be issued. Sellers will not be entitled to any voting rights, rights to receive any dividends or distributions or other rights as a stockholder of Company with respect to any such fractional shares of Company Common Stock that would have otherwise been issued to such Seller.
(e) Share Conversion. Conditional upon the Company Stockholder Approval, each Seller hereby irrevocably agrees to the Share Conversion upon the terms described herein, which shall be deemed to occur immediately prior to the Closing.
(a) Not less than five (5) calendar days prior to the anticipated date for Closing (the Anticipated Closing Date), Company will deliver to F-Star a schedule (the Net Cash Schedule) setting forth, in reasonable detail, Companys good faith, estimated calculation of Net Cash (the Net Cash Calculation and the date of delivery of such schedule, the Delivery Date) as of the close of business on the last Business Day prior to the Anticipated Closing Date (the Cash Determination Time) prepared and certified by Companys Chief Financial Officer (or if there is no Chief Financial Officer, Companys principal accounting officer). Company shall make available to F-Star, as requested by F-Star, the work papers and back-up materials used in or reasonably relevant to the preparation of the Net Cash Schedule and, if reasonably requested by F-Star, Companys accountants and counsel at reasonable times and upon reasonable advance notice.
(b) Within three (3) calendar days after the Delivery Date (the last day of such period, the Response Date), F-Star shall have the right to dispute any part of the Net Cash Calculation by delivering a written notice to that effect to Company (a Dispute Notice). Any Dispute Notice shall identify in reasonable detail and to the extent known the nature and amounts of any proposed revisions to the Net Cash Calculation F-Star reasonably believes to be necessary and appropriate.
(c) If, on or prior to the Response Date, F-Star notifies Company in writing that it has no objections to the Net Cash Calculation or, if F-Star fails to deliver a Dispute Notice as provided in Section 1.5(b) by 11:59 p.m. Eastern Time on the Response Date, then the Net Cash Calculation as set forth in the Net Cash Schedule shall be deemed to have been finally determined for purposes of this Agreement and to represent the Net Cash at the Cash Determination Time for all purposes under this Agreement.
(d) If F-Star timely delivers a Dispute Notice to Company, then Representatives of Company and F-Star shall promptly meet and attempt in good faith to resolve any disputes between them regarding the Net Cash Calculation and negotiate an agreed-upon determination of Net Cash, which agreed upon Net Cash amount shall be deemed to have been finally determined for purposes of this Agreement and to represent the Net Cash at the Cash Determination Time for all purposes under this Agreement.
(e) If Representatives of Company and F-Star are unable to negotiate an agreed-upon determination of Net Cash as of the Cash Determination Time pursuant to Section 1.5(d) within three (3) calendar days after delivery of the Dispute Notice (or such other period as Company and F-Star may mutually agree upon), then any remaining matters in dispute regarding the calculation of Net Cash shall be referred to Grant Thornton LLP (the Accounting Firm). At the Accounting Firms request, (i) Company shall promptly make available or deliver to the Accounting Firm such work papers and back-up materials used by Company in preparing the Net Cash Schedule as the Accounting Firm reasonably requests, and (ii) F-Star shall promptly make available or deliver to the Accounting Firm such work papers and back-up materials used by F-Star in disputing Companys Net Cash Calculation as the Accounting Firm reasonably requests, and Company and F-Star shall use commercially reasonable efforts to cause the Accounting Firm to resolve all remaining matters in dispute within five (5) Business Days of accepting its selection. Company and F-Star shall be afforded the opportunity to present to the Accounting Firm any material related to all matters in dispute and to discuss the basis for such dispute with the Accounting Firm; provided, however, that no such presentation or discussion shall occur without the presence
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of a Representative of each of Company and F-Star. The determination of the Accounting Firm shall be limited to the matters in dispute submitted to the Accounting Firm for final determination. The Accounting Firm shall act as an expert and not as an arbitrator and shall be instructed to resolve only such matters relating to the calculation of Net Cash as are then in dispute. The resolution of the matters in dispute made by the Accounting Firm and the resulting calculation of the amount of Net Cash giving effect to such resolution shall be made in writing and delivered to each of Company and F-Star, shall be final and binding on Company and F-Star and shall be deemed to have been finally determined for purposes of this Agreement and to represent the Net Cash at the Cash Determination Time for all purposes under this Agreement. The Parties shall delay the Closing until the resolution of the matters described in this Section 1.5(e). The fees and expenses of the Accounting Firm shall be allocated between Company and F-Star in the same proportion that the amount of the matters in dispute that were unsuccessfully disputed by such Party (as finally determined by the Accounting Firm) bears to the total amount of all disputed matters resolved by the Accounting Firm. If this Section 1.5(e) applies as to the determination of the Net Cash at the Cash Determination Time described in Section 1.5(a), upon resolution of the matters in dispute in accordance with this Section 1.5(e), the Parties shall not be required to determine Net Cash again even though the Closing Date may occur later than the Anticipated Closing Date, except that either Company or F-Star may request a redetermination of Net Cash (using the principles established by the Accounting Firm in resolving the matters in dispute pursuant to this Section 1.5(e)) if the Closing Date is more than seven (7) calendar days after the Anticipated Closing Date.
(f) In the event that Net Cash, as finally determined pursuant to this Section 1.5, exceeds the Net Cash Limit, Company shall declare and pay the Permitted Dividend to holders of Company Common Stock of record as of immediately prior to the Closing.
1.6 F-Star Loan Notes. Capitalized terms used in this Section 1.6 and not otherwise defined have the respective meanings ascribed in the 2019 Loan Note Instrument.
(a) F-Star and each of the 2019 Loan Note Holders (representing a Noteholder Majority) by their execution and delivery of this Agreement hereby irrevocably agree and acknowledge that this Agreement constitutes notice in writing that the F-Star Pre-Closing Financing will constitute a Relevant Fundraising for the purposes of the 2019 Loan Note Instrument notwithstanding that the aggregate proceeds of the F-Star Pre Closing Financing together with the nominal value of the 2019 Loan Notes which are converting are less than $50,000,000 in the aggregate.
(b) On the Closing Date immediately subsequent to the Share Conversion and simultaneously with the issuance of the F-Star Ordinary Shares in the F-Star Pre-Closing Financing, the 2019 Loan Notes shall automatically convert into fully paid F-Star Ordinary Shares (being, the class of Senior Shares as such term is defined in the 2019 Loan Note Instrument) in accordance with the terms of Part 2 of Schedule 2 to the 2019 Loan Note Instrument and the terms described below (the 2019 Loan Note Conversion). The 2019 Loan Note Holders, each by their execution and delivery of this Agreement as a Seller, hereby irrevocably agree and acknowledge as follows with respect to the 2019 Loan Note Conversion:
(i) the applicable Conversion Price (as such term is used in Part 2 of Schedule 2 to the 2019 Loan Note Instrument) shall be an amount equal to eighty percent (80%) of the price paid per F-Star Ordinary Share by participants in the F-Star Pre-Closing Financing and neither such price nor the number or nominal value of the F-Star Ordinary Shares issued pursuant to the 2019 Loan Note Conversion shall be subject to any adjustment under clause 2.6 of Part 2 of Schedule 2 to the 2019 Loan Note Instrument;
(ii) this Agreement shall constitute due prior written notice by F-Star of a Conversion Event (as such term is used in Part 2 of the Schedule 2 to the 2019 Loan Instrument) in accordance with the terms of paragraph 1.3, of Part 2 of Schedule 2 to the 2019 Loan Note Instrument;
(iii) each 2019 Loan Note Holder undertakes to F-Star that it will, prior to the 2019 Loan Note Conversion, deliver to F-Star its original certificate in respect of the 2019 Loan Notes it holds (or an indemnity in a form acceptable to F-Star and Company in respect thereof);
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(iv) that effective upon the 2019 Loan Note Conversion, neither F-Star nor Company shall have any further obligations to such 2019 Loan Note Holder (other than the issuance by F-Star of F-Star Ordinary Shares on the terms contemplated herein); and
(v) for the purposes of the 2019 Loan Note Instrument, each 2019 Loan Note Holder (representing, for such purposes, a Noteholder Majority) hereby approves the form and adoption by F-Star of the Closing Articles of Association.
(c) Each 2019 Loan Note Holder hereby irrevocably (i) undertakes, subject to Section 6.11(b), to not transfer any of the 2019 Loan Notes in advance of the 2019 Loan Note Conversion and (ii) consents to the 2019 Loan Note Conversion upon the terms stated herein; and (iii) hereby agrees that with effect from closing of the 2019 Loan Note Conversion, each 2019 Loan Note shall have been duly satisfied and as a result, the terms of the 2019 Loan Note Instrument as applicable to the 2019 Loan Notes constituted thereby, shall be terminated and of no further force or effect as between F-Star and the 2019 Loan Note Holders.
(a) Each holder of Company Common Stock of record as of immediately prior to the Closing shall be entitled to (i) one (1) contractual contingent value right (a STING Agonist CVR) issued by Company, subject to and in accordance with the terms and conditions of the CVR Agreement in the form of Exhibit E-1 attached hereto (the STING Agonist CVR Agreement), and (ii) one (1) contractual contingent value right (a STING Antagonist CVR and, together with the STING Agonist CVR, the CVRs and individually a CVR) issued by Company, subject to and in accordance with the terms and conditions of the CVR Agreement in the form of Exhibit E-2 attached hereto (the STING Antagonist CVR Agreement and, together with the STING Agonist CVR Agreement, the CVR Agreements) for each share of Company Common Stock held by such holder.
(b) At or prior to the Closing, Company and F-Star each shall authorize and duly adopt, execute and deliver, and Company will ensure that the Exchange Agent (in its capacity as Rights Agent (as defined in the CVR Agreements)) executes and delivers, the CVR Agreements, subject to any reasonable revisions to the CVR Agreements that are requested by the Exchange Agent (provided that such revisions are not, individually or in the aggregate, detrimental or adverse, taken as a whole, to any holder of a CVR). Company and F-Star shall cooperate, including by making changes to the forms of CVR Agreements, as necessary to ensure that the CVRs are not subject to registration under the Securities Act, the Securities Exchange Act of 1934, as amended (the Exchange Act), or any applicable state securities or blue sky laws.
1.8 Preliminary Consents and Associated Acknowledgments of Sellers.
(a) Sellers (including, for the avoidance of doubt, any Person who becomes a Seller by execution of a Joinder Agreement after the date hereof) hereby, on a several and not joint basis:
(i) consent and agree for the purpose of each applicable provision of the Shareholders Agreement, the Articles of Association and otherwise, to the adoption by F-Star of the Closing Articles of Association and to F-Star entering into this Agreement and taking all such actions as may be required for the purpose of effecting the Contemplated Transactions; and
(ii) acknowledge and agree that, for the purpose of the Articles of Association, the Conversion Ratio (as defined in the Articles of Association and as it applies to any share of any class in the capital of F-Star) that is to be applied in connection with the Share Conversion and the Acquisition shall not be subject to any adjustment in accordance with Article 9.7 of the Articles of Association.
(b) Such of the Sellers who are holders of F-Star Series A Preference Shares and F-Star Seed Preference Shares, on a several and not joint basis, hereby consent and agree to the conversion of all of their F-Star Series A Preference Shares and F-Star Seed Preference Shares into F-Star Ordinary Shares in accordance with the terms of this Agreement and such agreement shall hereby be deemed to constitute;
(i) notice of a Qualified Preference Majority under Article 9.1 of the Articles of Association (as that term is therein defined); and
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(ii) acknowledgement and agreement that notwithstanding Article 9.2(a) of the Articles of Association, the Share Conversion will take effect immediately prior to Closing in accordance with this Agreement and not on the date of the notice given pursuant to this Agreement.
(c) F-Star and Sellers (including, for the avoidance of doubt, any Person who becomes a Seller by execution of a Joinder Agreement after the date hereof), on a several and not joint basis, hereby agree that:
(i) Articles 5 and 6 of the Articles of Association will not apply for the purpose of the Acquisition, with the allocation and distribution of the Proceeds of Sale (as defined in the Articles of Association) as among Sellers to be governed by the terms of this Agreement; and
(ii) subject to and with effect from Closing, the Shareholders Agreement will terminate, and each party to the Shareholders Agreement shall, prior to the Closing, deliver to the Company a deed of termination to the Shareholders Agreement substantially in such form attached as Exhibit F (the Deed of Termination-Shareholders Agreement) subject to and with effect from Closing, releasing and discharging each other party thereto from all claims or demands under or in connection with the Shareholders Agreement.
(d) Each Seller (including, for the avoidance of doubt, any Person who becomes a Seller by execution of a Joinder Agreement after the date hereof) undertakes to F-Star that such Seller will, prior to the Share Conversion, deliver to F-Star for cancellation all original certificates (or an indemnity in a form acceptable to F-Star in respect thereof) for all F-Star Seed Preference Shares and F-Star Series A Preference Shares held by such Seller that are to be converted into F-Star Ordinary Shares pursuant to the Share Conversion.
1.9 Delivery of Acquisition Consideration.
(a) Exchange Agent. On or prior to the Closing Date, Company will select Computershare Trust Company N.A. or another reputable bank or trust company reasonably acceptable to F-Star to act as exchange agent in connection with the Acquisition and the other Contemplated Transactions (the Exchange Agent). At or prior to the Closing, Company will issue and cause to be deposited with the Exchange Agent, for the benefit of Sellers, for exchange in accordance with this Article 1, through the Exchange Agent, uncertificated book-entries representing such aggregate number of shares of Company Common Stock to be issued pursuant to Section 1.4, and, after the Closing, the Exchange Agent shall be authorized to issue the shares of Company Common Stock in accordance with this Agreement.
(b) Exchange Procedures. On or prior to the Closing, each Seller, as a condition to receiving the applicable Acquisition Consideration, will deliver to the Exchange Agent (i) a duly executed stock transfer form in favor of Company in customary form approved by Company in respect of the F-Star Shares held by such Seller, and (ii) in respect of all F-Star Shares held by such Seller, certificate(s) evidencing title to such shares or an indemnity for any lost certificates made in favor of F-Star and Company in a form reasonably acceptable to Company. As promptly as practicable after receipt by the Exchange Agent from a Seller of the aforementioned stock transfer form and F-Star share certificate(s), together with such other customary documents as may reasonably be required by the Exchange Agent or Company, such Seller shall receive, from the Exchange Agent, in exchange therefor, a number of whole shares of Company Common Stock represented, at such Sellers election, by book entry or certificated shares equal to the number of whole shares of Company Common Stock that such Seller has the right to receive pursuant to the provisions of Section 1.4.
(c) Transfers of Ownership. If any shares of Company Common Stock are to be issued in a name other than that in which the F-Star share certificate surrendered in exchange therefor is registered, it will be a condition of the issuance thereof that the F-Star share certificate so surrendered will be in proper form for transfer and that the Person requesting such exchange will have paid to Company or any Person designated by it any transfer or other Taxes required by reason of the issuance of the shares of Company Common Stock in any name other than that of the registered holder of the F-Star share certificate surrendered, or established to the satisfaction of Company or any agent designated by it that such Tax has been paid or is not payable.
(d) Withholding Rights. Each of the Exchange Agent, Company and F-Star will be entitled to deduct and withhold from any consideration payable or otherwise deliverable pursuant to this Agreement any amounts
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that are required to be deducted or withheld from that consideration under the Code, Treasury Regulations promulgated under the Code or any provisions of applicable state, local or foreign Tax law. To the extent any amounts are withheld in accordance with the provisions of this Agreement and are paid over to the applicable Governmental Body, such amounts will be treated for all purposes under this Agreement as having been paid to the Person to whom such amounts would otherwise have been paid.
(a) Appointment and Powers. Each Seller hereby nominates and appoints Company, with effect from the Closing, to be its lawful agent, proxy and attorney, and grants to Company a power-of-attorney, with full power to exercise all rights pertaining to any F-Star Shares registered in the name of such Seller as Company in its absolute discretion sees fit, including (but not limited to):
(i) receiving notice of, attending and voting at any general meeting of the members of F-Star, including meetings of the members or any particular class of members, and all or any adjournments of such meetings, or signing any resolution as registered holder of such F-Star Shares;
(ii) completing and returning proxy cards, consents to short notice and any other documents required to be signed by the registered holder of such F-Star Shares;
(iii) except in respect of the Acquisition Consideration, dealing with and giving directions as to any moneys, securities, benefits, documents, notices or other communications (in whatever form) arising by right of such F-Star Shares or received in connection with such F-Star Shares from F-Star or any other Person; and
(iv) otherwise executing, delivering and doing all deeds, instruments and acts in such Sellers name insofar as may be properly done in that Sellers capacity as registered holder of such F-Star Shares.
(b) Sellers Undertakings. Each Seller undertakes, with effect from Closing, in respect of each F-Star Share then registered in such Sellers name, and for so long as such F-Star Share remains registered in such Sellers name:
(i) not to exercise any rights attaching to such F-Star Share or exercisable in such Sellers capacity as registered holder of such F-Star Share without Companys prior written consent;
(ii) with respect to the Acquisition Consideration, to hold on trust for Company all dividends and other distributions received by such Seller in respect of such F-Star Share and promptly notify Company of anything received by such Seller in such Sellers capacity as registered holder of such F-Star Share;
(iii) to act promptly in accordance with Companys instructions in relation to any rights exercisable or anything received by such Seller in such Sellers capacity as registered holder of such F-Star Share; and
(iv) to ratify and confirm whatever Company does or purports to do in good faith in the exercise of any power conferred by this power of attorney.
(c) Duration. The power of attorney granted by each Seller pursuant to this Section 1.10 shall expire on the date on which Company is entered into F-Stars register of members as the holder of the F-Star Shares that were registered in the name of such Seller at the Closing. For such purposes and following its receipt of all original stock transfer forms required to be delivered to it pursuant to this Agreement, F-Star, on Companys behalf, shall promptly submit the same to HM Revenue & Customs for stamping.
1.11 No Further Rights. The Acquisition Consideration delivered upon the surrender for exchange of F-Star Shares in accordance with the terms of this Agreement will be deemed to have been issued in full satisfaction of all rights pertaining to such shares.
1.12 Additional Actions. If, at any time after the Closing, Company shall consider or be advised that any deeds, bills of sale, assignments or assurances or any other acts or things are necessary, desirable or proper (a) to vest, perfect or confirm, of record or otherwise, in it its right, title and interest in, to or under any of the rights,
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privileges, powers or franchises of the F-Star Shares, or (b) otherwise to carry out the purposes of this Agreement, Company and its proper officers and directors or their designees shall be authorized (i) to execute and deliver, in the name and on behalf of each Seller and F-Star, all such deeds, bills of sale, assignments and assurances and (ii) to do, in the name and on behalf of each Seller and F-Star, all such other acts and things as may be necessary, desirable or proper to vest, perfect or confirm Companys right, title and interest in, to and under any of the rights, privileges, powers or franchises of F-Star Shares and otherwise to carry out the purposes of this Agreement; provided that, prior to executing and delivering any deed, bill of sale, assignment or assurance or doing any other act or thing in the name of and on behalf of any Seller pursuant to this Section 1.12, Company shall use reasonable efforts to contact such Seller and request that such Seller execute and deliver such deed, bill of sale, assignment or assurance or do such other act or thing.
REPRESENTATIONS AND WARRANTIES OF F-STAR
F-Star represents and warrants to Company as follows (it being understood that each representation and warranty contained in this Article 2 is subject to: (a) the exceptions and disclosures set forth in the part or subpart of the F-Star Disclosure Schedule corresponding to the particular Section or subsection in this Article 2 in which such representation and warranty appears; (b) any exceptions or disclosures explicitly cross-referenced in such part or subpart of the F-Star Disclosure Schedule by reference to another part or subpart of the F-Star Disclosure Schedule; and (c) any exception or disclosure set forth in any other part or subpart of the F-Star Disclosure Schedule to the extent it is reasonably apparent from the wording of such exception or disclosure that such exception or disclosure qualifies such representation and warranty):
2.1 Organization and Qualification; Charter Documents.
(a) Part 2.1(a) of the F-Star Disclosure Schedule identifies each Subsidiary of F-Star and indicates its jurisdiction of organization. None of the F-Star Companies own any capital stock of, or any equity interest of any nature in, any other Entity, other than the Entities identified in Part 2.1(a) of the F-Star Disclosure Schedule. None of the F-Star Companies has agreed or is obligated to make, or is bound by any Contract under which it may become obligated to make, any future equity investment in or capital contribution to any other Entity.
(b) Each of the F-Star Companies is a corporation duly organized and validly existing under the laws of the jurisdiction of its incorporation and has all necessary corporate power and authority: (i) to conduct its businesses in the manner in which its business is currently being conducted; (ii) to own and use its assets in the manner in which its assets are currently owned and used; and (iii) to perform its obligations under all F-Star Contracts by which it is bound, except where the failure to have such corporate power and authority would not, individually or in the aggregate, have an F-Star Material Adverse Effect. The Organizational Documents of each F-Star Company, copies of which have previously been made available to Company, are true, correct and complete copies of such documents as currently in effect and no F-Star Company is in violation of any provision thereof in any material respect.
(c) Each of the F-Star Companies (in jurisdictions that recognize the following concepts) is qualified to do business as a foreign corporation, and is in good standing, under the laws of all jurisdictions where the nature of its business requires such qualification, except where the failure to be so qualified and in good standing would not, individually or in the aggregate, have an F-Star Material Adverse Effect.
(a) As of the date hereof, the issued share capital of F-Star consists of (i) 16,265,864 ordinary shares of F-Star, par value £0.01 per share (F-Star Ordinary Shares), (ii) 103,611 seed voting preference shares of F-Star, par value £0.01 per share (F-Star Seed Preference Shares), and (iii) 1,441,418 series A voting preference shares of F-Star, par value £0.01 per share (F-Star Series A Preference Shares and such issued F-Star Series A Preference Shares, together with such issued F-Star Ordinary Shares and such issued F-Star Seed Preference Shares, collectively, F-Star Issued Share Capital). In the 2019 Loan Note Conversion, each 2019
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Loan Note will convert into a number of F-Star Ordinary Shares equal to the quotient of (x) the aggregate principal amount plus interest accruing under such 2019 Loan Note divided by (y) an amount equal to eighty percent (80%) of the price paid per F-Star Ordinary Share by participants in the F-Star Pre-Closing Financing, rounded down to the nearest whole F-Star Ordinary Share. In the Share Conversion, the F-Star Seed Preference Shares and F-Star Series A Preference Shares will convert into an aggregate of 1,545,029 F-Star Ordinary Shares. All F-Star Issued Share Capital is, and immediately prior to Closing, all F-Star Shares will be, duly authorized, validly issued and fully paid and was, or will be, issued in compliance with all applicable Legal Requirements. Part 2.2(a) of the F-Star Disclosure Schedule sets forth the complete and accurate capitalization (excluding F-Star Options and F-Star RSUs) of the F-Star Companies as of the date hereof (including the name of each holder of F-Star Issued Share Capital and 2019 Loan Notes and the number of shares in the F-Star Issued Share Capital and 2019 Loan Notes held by such holder). As of the date of this Agreement, assuming that the F-Star Pre-Closing Financing (for purposes of this sentence, assuming the F-Star Pre-Closing Financing consists solely of the issuance of F-Star Share Capital) were consummated for the Target Proceeds on the date hereof and F-Star Ordinary Shares were subscribed for in the F-Star Pre-Closing Financing at a price of $1.49 per F-Star Ordinary Share resulting in aggregate gross proceeds to F-Star equal to the Target Proceeds and that the Conversions occurred on the date of this Agreement, there would be 47,144,686 F-Star Ordinary Shares issued, 5,063,660 F-Star Ordinary Shares issuable upon the exercise of the F-Star Options, and 620,000 F-Star Ordinary Shares issuable upon the vesting of the F-Star RSUs and no other shares in the F-Star Share Capital would be issued or issuable upon the exercise or conversion of any securities of F-Star or upon the exchange of any such securities and no Person would have the right to cause F-Star to issue any shares in the F-Star Share Capital except for the issuance of F-Star Ordinary Shares upon the exercise of certain F-Star Options or vesting of certain F-Star RSUs that Company or F-Star, on behalf of Company, have the right and obligation to procure the compulsory purchase of pursuant to Section 6.15. As of the Closing, Part 2.2(a) of the F-Star Disclosure Schedule, as updated pursuant to Section 6.19 and delivered to Company prior to the Closing, will set forth the complete and accurate capitalization (excluding F-Star Options and F-Star RSUs) of the F-Star Companies after giving effect to the issuance of F-Star Ordinary Shares in the F-Star Pre-Closing Financing, the Conversions, and the issuance of F-Star Ordinary Shares pursuant to the exercise of F-Star Options or the vesting of F-Star RSUs, in each case, outstanding on the Closing Date in accordance with the terms under the F-Star Equity Plans and any other securities issued after the date hereof in accordance with Section 5.2(b). As of the Closing, all of the F-Star Share Capital listed on such updated Part 2.2(a) of the F-Star Disclosure Schedule will constitute F-Star Shares hereunder and no other shares in the F-Star Share Capital would be issued or issuable upon the exercise or conversion of any securities of F-Star or upon the exchange of any such securities and no Person would have the right to cause F-Star to issue any shares in the F-Star Share Capital except for the issuance of F-Star Ordinary Shares upon the exercise of certain F-Star Options or the vesting of certain F-Star RSUs that Company or F-Star, on behalf of Company, have the right and obligation to procure the compulsory purchase of pursuant to Section 6.15.
(b) As of the date hereof, F-Star had reserved an aggregate of 5,633,347 F-Star Ordinary Shares for issuance under the F-Star EIP, under which options were outstanding for an aggregate of 4,713,542 F-Star Ordinary Shares and F-Star RSUs were outstanding for an aggregate of 620,000 F-Star Ordinary Shares. Options under the F-Star Legacy Plans are outstanding representing a total of 350,118 F-Star Ordinary Shares and no further F-Star Options may be granted under the F-Star Legacy Plans. All F-Star Ordinary Shares subject to issuance pursuant to an F-Star Option or an F-Star RSU, upon issuance on the terms and conditions specified in the instruments pursuant to which they are issuable, would be duly authorized, validly issued, fully paid and non-assessable and would be issued in compliance with all applicable Legal Requirements. The document in the Part 2.2(b) Folder in the F-Star Data Room lists each outstanding F-Star Option and F-Star RSU outstanding as of the date hereof, the name of the holder of such option or unit, the number of shares subject to such option or unit, the exercise price of such option, the vesting schedule and termination date of such option or unit, and whether the exercisability of such option or vesting or settlement of such unit will be accelerated in any way by the Contemplated Transactions. Each F-Star Option was granted with an exercise price not less than the fair market value of an F-Star Ordinary Share on the date such option was approved by the board of directors of
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F-Star or an authorized committee or representative thereof. All F-Star Options and all F-Star RSUs were granted under the F-Star Equity Plans.
(c) Except as set forth on Part 2.2(c) of the F-Star Disclosure Schedule: (i) none of the shares of F-Star Share Capital or shares in the capital of any of F-Stars Subsidiaries are entitled or subject to any preemptive right, right of repurchase or forfeiture, right of participation, right of maintenance or any similar right; (ii) none of the shares of F-Star Share Capital or shares in the capital of any of F-Stars Subsidiaries are subject to any right of first refusal; (iii) there are no outstanding bonds, debentures, notes or other indebtedness of the F-Star Companies having a right to vote on any matters on which the holders of shares of F-Star Share Capital or holders of shares in the capital of any of F-Stars Subsidiaries have a right to vote; (iv) except for the Shareholders Agreement and the F-Star Pre-Closing Financing Agreements, there is no Contract to which an F-Star Company is a party relating to the voting or registration of, or restricting any Person from purchasing, selling, pledging or otherwise disposing of (or from granting any option or similar right with respect to), any shares of F-Star Share Capital or shares in the capital of any of F-Stars Subsidiaries; and (v) no F-Star Company is under any obligation, or bound by any Contract pursuant to which it may become obligated, to repurchase, redeem or otherwise acquire any shares of F-Star Share Capital or shares in the capital of any of F-Stars Subsidiaries or other securities. As of the date hereof, there are no shares of F-Star Share Capital that are subject to a repurchase option, risk of forfeiture or other condition under any Contract with F-Star or under which F-Star or, to the knowledge of F-Star, any Seller has any rights.
(d) Upon Closing and assuming the satisfaction or waiver of the conditions to Closing set forth in Article 7, Company will acquire all F-Star Shares free and clear of any Encumbrance, and pursuant to the provisions of Section 6.15, the Company or F-Star on the Companys behalf, will have the right to acquire all shares in the F-Star Share Capital issuable after Closing upon the exercise of any F-Star Option or the vesting of any F-Star RSU which is not exchanged pursuant to the provisions of Section 6.15 free and clear of any Encumbrance.
2.3 Authority; Non-Contravention; Approvals.
(a) F-Star has the requisite corporate power and authority to enter into this Agreement and to perform its obligations hereunder and to consummate the Contemplated Transactions. The execution and delivery by F-Star of this Agreement, the performance by F-Star of its obligations hereunder and the consummation by F-Star of the Contemplated Transactions have been duly authorized by all necessary corporate action on the part of F-Star. This Agreement has been duly executed and delivered by F-Star and, assuming the due authorization, execution and delivery of this Agreement by Company and Sellers, this Agreement constitutes the valid and binding obligation of F-Star, enforceable in accordance with its terms, subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other laws affecting creditors rights generally and general principles of equity.
(b) Except as set forth in Part 2.3(b) of the F-Star Disclosure Schedule, the execution and delivery of this Agreement by F-Star does not, and the performance of this Agreement by F-Star will not, (i) conflict with or violate any Organizational Documents of any F-Star Company, (ii) subject to compliance with the requirements set forth in Section 2.3(c) below, conflict with or violate any Legal Requirement or Order applicable to the F-Star Companies or by which any of their respective properties are bound or affected, except for any such conflicts or violations that would not, individually or in the aggregate, have an F-Star Material Adverse Effect, or (iii) require an F-Star Company to make any filing with or give any notice to a Person, or to obtain any Consent from a Person, or result in any breach of or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or impair F-Stars rights or alter the rights or obligations of any third party under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of a lien or encumbrance on any of the properties or assets of the F-Star Companies, except, for purposes of this clause (iii), as would not, individually or in the aggregate, have an F-Star Material Adverse Effect.
(c) No consent, approval, order or authorization of, or registration, declaration or filing with, any Governmental Body is required by or with respect to F-Star in connection with the execution and delivery of this Agreement or the consummation of the Contemplated Transactions, except for (i) the filing of the Registration
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Statement with the SEC, (ii) any filings contemplated by Section 6.4(a), or (iii) those consents obtained from Sellers by their execution and delivery of this Agreement by Sellers.
2.4 F-Star Financial Statements; No Undisclosed Liabilities.
(a) The audited consolidated financial statements (including any related notes thereto) consisting of results of operations and statements of changes in cash flow of F-Star and its Subsidiaries as of and for the years ended December 31, 2017, December 31, 2018 and December 31, 2019 (collectively, the F-Star Audited Financials), which include the comparative financial statements of F-star Delta Ltd only for the years ended December 31, 2017 and December 31, 2018, and the audited consolidated financial statements (including any related notes thereto) consisting of results of operations and statements of changes in cash flow F-star Beta Ltd (Beta) and F-star Biotechnologische Forschungs-und Entwicklungsges, M.B.H. (GmbH and, together with Beta, the F-Star Predecessor Group) as of the year ended December 31, 2018 and the period ended May 6, 2019 and the results of operations and statements of changes in cash flow for the years ended December 31, 2017 and December 31, 2018 and the period ended May 6, 2019 (collectively, the F-Star Predecessor Audited Financials) will, when delivered to Company, (i) comply as to form in all material respects with the published rules and regulations of the SEC applicable thereto and be suitable for inclusion in the Proxy Statement and the Registration Statement, (ii) have been prepared in accordance with the International Financial Reporting Standards (IFRS) applied on a consistent basis throughout the periods involved (except as may be indicated in the notes thereto), (iii) fairly present, in all material respects, the consolidated financial position of the F-Star Companies or the F-Star Predecessor Group, as applicable, as at the respective dates thereof and the consolidated results of their operations and cash flows for the periods indicated and (iv) be consistent with, and have been prepared from, the books and records of the F-Star Companies or the F-Star Predecessor Group, as applicable.
(b) The unaudited consolidated financial statements (including any related notes thereto) representing the financial condition of F-Star Companies as of and for the six (6)-month period ended June 30, 2020 and the six (6)-month period ended June 30, 2019, and F-Star financial statements as of and for the period ending on any fiscal quarter end or annual period after the date hereof and prior to the Closing that are required to be included in the Registration Statement, if any, in each case together with the notes thereto (the F-Star Unaudited Financials, and together with the F-Star Audited Financials and the F-Star Predecessor Audited Financials, the F-Star Financials), will, when delivered to Company, (i) comply as to form in all material respects with the published rules and regulations of the SEC applicable thereto and be suitable for inclusion in the Proxy Statement and the Registration Statement, (ii) have been prepared in good faith, (iii) fairly present, in all material respects, the consolidated financial position of the F-Star Companies as at the respective dates thereof and the consolidated results of the F-Star Companies operations and cash flows for the periods indicated and (iv) be consistent with (subject to normal and recurring year-end adjustments that are not reasonably expected to be material in amount), and have been prepared from, the books and records of the F-Star Companies.
(c) F-Star maintains a system of internal accounting controls designed to provide reasonable assurance that: (i) transactions are executed in accordance with managements general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain asset accountability; (iii) access to assets is permitted only in accordance with managements general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. F-Star maintains internal control over financial reporting that provides reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS.
(d) As of the date of this Agreement, no F-Star Company has any liabilities (other than valuation adjustments in relation to financial instruments), indebtedness, obligations or expense of any kind, whether absolute, accrued, contingent, matured or unmatured or otherwise (each, a Liability), of a type required to be reflected in financial statements prepared in accordance with IFRS, which are, individually or in the aggregate, material to the business, results of operations or financial condition of the F-Star Companies taken as a whole, except for (i) Liabilities reflected on the F-Star Audited Financials or the F-Star Predecessor Audited Financials,
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(ii) Liabilities incurred by any F-Star Company since the date of the F-Star Audited Financials in the ordinary course of business and which are not in excess of $250,000, in the aggregate, (iii) Liabilities incurred in connection with the Contemplated Transactions, (iv) Liabilities for performance of obligations of F-Star or any Subsidiary under any F-Star Contract (other than for breach thereof), and (v) Liabilities disclosed on Part 2.4(d) of the F-Star Disclosure Schedule. No F-Star Company has effected any off-balance sheet arrangements (as defined in Item 303(a) of SEC Regulation S-K) since January 1, 2017.
(e) Since January 1, 2017, there have been no formal investigations regarding financial reporting or accounting policies and practices discussed with, reviewed by or initiated at the direction of the chief executive officer, chief financial officer or general counsel of F-Star, the board of directors of F-Star or any committee thereof.
(f) Since January 1, 2017, neither F-Star nor, to the knowledge of F-Star, its Representatives, have identified any fraud, whether or not material, that involves F-Stars management or other employees who have a role in the preparation of financial statements or any claim or allegation regarding any of the foregoing. No F-Star Companies have identified or been made aware of any fraud, whether or not material, that involved F-Stars management or other employees who have a role in the preparation of financial statements or the internal accounting controls utilized by F-Star, any material illegal act or fraud related to the business of the F-Star Companies, or any claim or allegation regarding the foregoing.
2.5 Absence of Certain Changes or Events. From December 31, 2019 through the date hereof, each of the F-Star Companies has conducted its business in all material respects in the ordinary course of business consistent with past practice and there has not been (a) any event that has had an F-Star Material Adverse Effect or (b) any action, event or occurrence that would have required the consent of Company pursuant to Section 5.2 had such action, event or occurrence taken place after the execution and delivery of this Agreement.
2.6 Taxes. Each of the representations and warranties set forth in this Section 2.6 is qualified by except as would not, individually or in the aggregate, have an F-Star Material Adverse Effect.
(a) Each income Tax Return and each other material Tax Return that were required to be filed by or with respect to any F-Star Company has been timely filed (taking into account all valid extensions), and all such Tax Returns were true, complete and accurate in all respects. All Taxes due and payable by the F-Star Companies (whether or not shown on any Tax Return) have been timely paid, except to the extent such amounts are being contested in good faith and are properly reserved for on the books or records of the F-Star Companies to the extent any such reserve is required under IFRS.
(b) No waiver or agreement by or with respect to an F-Star Company is in force for the extension of time for the payment, collection or assessment of any Taxes, and no request has been made by an F-Star Company in writing for any such extension or waiver.
(c) There are no liens for Taxes on any asset of an F-Star Company other than liens for Taxes not yet due and payable or Taxes contested in good faith and reserved against in accordance with IFRS.
(d) No F-Star Company is the subject of any currently ongoing Tax audit or other proceeding with respect to Taxes nor has any audit or other proceeding with respect to Taxes been proposed against any of them in writing, and any deficiencies asserted or assessments made as a result of any audit or other proceeding with respect to Taxes have been paid in full or adequate accruals or reserves for any such deficiencies or assessments have been established and are reflected on Part 2.6(d) of the F-Star Disclosure Schedule and will be reflected in the F-Star Financials.
(e) All material Taxes that an F-Star Company has been required to collect or withhold have been duly collected or withheld and, to the extent required by applicable Legal Requirements when due, have been duly and timely paid to the proper Governmental Body.
(f) No closing agreements, private letter rulings, technical advice memoranda or similar agreements or rulings have been entered into by any F-Star Company with any taxing authority or issued by any taxing authority to an F-Star Company. There are no outstanding rulings of, or request for rulings with, any
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Governmental Body addressed to an F-Star Company that are, or if issued would be, binding on any F-Star Company.
(g) No F-Star Company is a party to any Contract with any Person (other than one or more F-Star Companies) relating to allocating or sharing the payment of, or Liability for, Taxes or Tax benefits (other than pursuant to customary provisions included in agreements not primarily related to Taxes and entered into in the ordinary course of business). No F-Star Company has any Liability for the Taxes of any Person (other than one or more F-Star Companies) as a transferee or successor or otherwise by operation of Legal Requirements.
(h) Within the past two (2) years, no F-Star Company has been a member of an affiliated group of corporations within the meaning of Section 1504 of the Code or of any group that has filed a combined, consolidated or unitary Tax Return under state, local or foreign Tax Legal Requirement (other than a group the common parent of which was F-Star).
(i) No F-Star Company has participated in, or is currently participating in, a listed transaction within the meaning of Treasury Regulation Section 1.6011-4(b)(2) or 301.6111-2(b)(2).
(j) Within the past two (2) years, no F-Star Company has distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by Sections 355 or 361 of the Code.
(k) No F-Star Company is, or ever has been, a controlled foreign corporation, as such term is defined in Section 957 of the Code.
(l) Except as set forth on Part 2.6(l) of the F-Star Disclosure Schedule, there is no obligation on any F-Star Company to deduct or withhold United Kingdom Tax in respect of any borrowing or other debt in respect of any premium, interest or other amount comprising such borrowing or other debt and no obligation on any F-Star Company to pay an increased sum where United Kingdom Tax is withheld or payable.
(m) No person has acquired any employment related securities (as defined in section 421B(8) of ITEPA) or any interest in any employment related securities and no person has acquired any securities options (as defined for the purposes of Part 7 of ITEPA), in each case, in relation to which an F-Star Company is, has been or will be the employer (as defined in section 421B(8) of ITEPA) and which would reasonably be expected to give rise to a United Kingdom Tax charge under Part 7 of ITEPA.
(n) No F-Star Company has at any time entered into or been party to any transactions, schemes or arrangements which either were notifiable arrangements for the purposes of Part 7 Finance Act 2004 (Disclosure of tax avoidance schemes) or was a notifiable scheme for the purposes of Schedule 11A VATA 1994 (Disclosure of avoidance schemes).
(a) Part 2.7(a)(i) of the F-Star Disclosure Schedule lists all of the Patent Rights, Trademark Rights (including domain name registrations) and registered Copyrights owned solely by or registered solely to any F-Star Company as of the date hereof, setting forth in each case, as applicable, the jurisdictions in which patents have been issued, patent applications have been filed, trademarks have been registered and trademark applications have been filed, along with the respective application, registration or filing number thereof. Part 2.7(a)(ii) of the F-Star Disclosure Schedule lists, as of the date hereof, all of the Patent Rights, Trademark Rights (including domain name registrations) and registered Copyrights in which any F-Star Company has any co-ownership interest, other than those owned solely by an F-Star Company, setting forth in each case, as applicable, the jurisdictions in which patents have been issued, patent applications have been filed, trademarks have been registered, trademark applications have been filed and registered copyrights and copyright applications have been filed, along with the respective application, registration or filing number thereof. Part 2.7(a)(iii) of the F-Star Disclosure Schedule lists all of the third party Patent Rights, Trademark Rights (including domain name registrations) and registered Copyrights in which an F-Star Company has any exclusive right, title or interest, other than those owned solely or co-owned by an F-Star Company and identified in Part 2.7(a)(i) or 2.7(a)(ii) of the F-Star Disclosure Schedule.
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(b) Part 2.7(b) of the F-Star Disclosure Schedule lists all Contracts in effect as of the date hereof under which any third party has licensed, granted or conveyed to any F-Star Company any right, title or interest in or to any F-Star IP Rights, other than (i) shrink wrap or click through license agreements accompanying widely available computer software that has not been modified or customized for an F-Star Company and where such software is not material to its business and (ii) when entered into in the ordinary course of business, material transfer agreements, clinical trial-related agreements (including Contracts with clinical research organizations), services agreements, non-disclosure agreements or other ordinary course Contracts with non-exclusive inbound licenses (including with research institutes). No F-Star Company and, to F-Stars knowledge, no other party to any such Contract has breached or violated in any material respect or materially defaulted under, or received notice that it has breached, violated or defaulted under, any of the terms or conditions of any such Contract.
(c) Part 2.7(c) of the F-Star Disclosure Schedule lists all Contracts in effect as of the date hereof under which an F-Star Company has licensed, granted or conveyed to any third party any right, title or interest in or to any F-Star IP Rights (collectively, Out Licenses); provided, that Out Licenses shall not include, when entered into in the ordinary course of business, material transfer agreements, clinical trial-related agreements (including Contracts with clinical research organizations), services agreements, non-disclosure agreements or other ordinary course Contracts with non-exclusive outbound licenses (including with research institutes). No F-Star Company and, to F-Stars knowledge, no other party to any such contract has breached or violated in any material respect or materially defaulted under, or received notice that it has breached, violated or defaulted under, any of the terms or conditions of any such Contract.
(d) The F-Star Companies own, co-own or otherwise possess legally enforceable rights in and to all F-Star Owned IP Rights, free and clear of all Encumbrances. The F-Star IP Rights that are owned by an F-Star Company and listed in Part 2.7(a)(i) of the F-Star Disclosure Schedule or co-owned by an F-Star Company and listed in Part 2.7(a)(ii) of the F-Star Disclosure Schedule (collectively, F-Star Registered IP Rights) are valid and subsisting and have not been found to be invalid or unenforceable by any Governmental Body. No third party is overtly challenging the right, title or interest of an F-Star Company in, to or under the F-Star Registered IP Rights, or the validity, enforceability or claim construction of any F-Star Registered IP Rights, and there is no opposition, cancellation, proceeding, objection or claim pending with regard to any F-Star Registered IP Rights. The F-Star Registered IP Rights are not subject to any outstanding order, judgment, decree or agreement affecting the F-Star Companies use thereof or their rights thereto. To the knowledge of F-Star, no valid basis exists for any of the foregoing challenges or claims. To the knowledge of F-Star, all necessary registration, maintenance and renewal fees in respect of the F-Star Registered IP Rights have been paid and all necessary documents and certificates have been filed with the relevant Governmental Body for the purpose of maintaining such F-Star Registered IP Rights.
(e) Each F-Star Company has taken reasonable measures to protect and maintain the confidentiality of the Trade Secrets included in the F-Star Owned IP Rights. The F-Star Companies have not divulged, furnished to or made accessible any of their Trade Secrets to any Person except (x) pursuant to an enforceable written agreement to maintain the confidentiality of such Trade Secrets, (y) to the United States Patent and Trademark Office (or any of its foreign equivalents) or (z) in connection with the filing of an application to obtain patent protection for the embodiment of such Trade Secret, and the F-Star Companies otherwise take and have taken reasonable measures to maintain the confidentiality of their Trade Secrets. All current and former officers and employees of, and consultants and independent contractors, each F-Star Company who has contributed to the creation or development of any material F-Star Owned IP Rights (i) have assigned all of their respective ownership rights in such IP Rights to such F-Star Company pursuant to written agreements that have executed and delivered to such F-Star Company (containing no exceptions or exclusions from the scope of the coverage contained in such F-Star Companys applicable form agreement) regarding the assignment to such F-Star Company (IP Assignment Agreements) and (ii) do not have any claim, right (whether or not currently exercisable) or interest to or in any F-Star Owned IP Rights. To the knowledge of F-Star, no current or former director, officer or employee of, or consultant or independent contractor to, any F-Star Company has breached any material term of any IP Assignment Agreements. All IP Assignment Agreements have been made available to Company.
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(f) To the knowledge of F-Star and except for any statutory exception to infringement, no current activity of any F-Star Company violates or infringes (directly, contributorily, by inducement, or otherwise), misappropriates or violates any IP Rights of any third party or makes unlawful use of any IP Right of any other Person. No infringement, misappropriation, or similar claim is pending or, to the knowledge of F-Star, threatened against any F-Star Company or against any other Person who is or may be entitled to be indemnified, defended, held harmless, or reimbursed by any F-Star Company with respect to such claim. Since January 1, 2015, no F-Star Company has received any written notice nor are any of them subject to any actual or, to the knowledge of F-Star, threatened proceedings, claiming or alleging any of the foregoing.
(g) To the knowledge of F-Star, no F-Star Owned IP Rights are being infringed, misappropriated or unlawfully used by any Person nor has any Person previously infringed, misappropriated or unlawfully used any such F-Star Owned IP Rights.
(h) Neither the execution, delivery or performance of this Agreement by F-Star nor the consummation by Sellers of the Contemplated Transactions will contravene, conflict with or result in the imposition of any additional limitation on the F-Star Companies right, title or interest in or to any material F-Star Owned IP Rights.
(i) No funding, facilities, or personnel of any Governmental Body or any public or private university, college or other educational or research institution were used by any F-Star Company to develop or create, in whole or in part, any F-Star Owned IP Rights that would grant any mandatory or compulsory ownership rights. No F-Star Company is now nor has any F-Star Company ever been a member or promoter of, or a contributor to, any industry standards body or similar organization that could require or obligate the F-Star Company to grant or offer to any other Person any license or right to any F-Star Owned IP Rights.
(j) To the knowledge of F-Star, no breach or violation of any electronic or other database containing (in whole or in part) Sensitive F-Star Company Data or any security policy of F-Star has occurred or is threatened, and there has been no unauthorized or illegal use of or access to information systems and/or the Sensitive F-Star Company Data. No Person (including any Governmental Body) has asserted a claim, or otherwise threatened in writing to commence any action, against any F-Star Company alleging a violation of any privacy policy of the F-Star Companies or the applicable Legal Requirements pertaining to privacy and data protection. No F-Star Company has received any written inquiry or complaint from any Governmental Body regarding the collection, use, retention, storage, security, transfer, disposal, disclosure or other processing of Sensitive F-Star Company Data by or for the F-Star Companies.
2.8 Compliance with Legal Requirements.
(a) Since January 1, 2017, no F-Star Company has been or is in conflict with, or in default or violation of, (i) any Legal Requirement or Order applicable to an F-Star Company or by which its properties is bound or affected, or (ii) any Contract to which an F-Star Company is a party or by which an F-Star Company or any of its properties is bound or affected, except for conflicts, defaults or violations which would not, individually or in the aggregate, have an F-Star Material Adverse Effect. No investigation or review by any Governmental Body is pending or, to the knowledge of F-Star, threatened against any F-Star Company, nor has any Governmental Body indicated to an F-Star Company in writing an intention to conduct the same.
(b) Except as would not, individually or in the aggregate, have an F-Star Material Adverse Effect, the F-Star Companies hold all permits, licenses, authorizations, variances, exemptions, orders and approvals from applicable Governmental Bodies which are necessary to the operation of the business of the F-Star Companies taken as a whole (collectively, the F-Star Permits). The F-Star Companies are in compliance in all material respects with the terms of the F-Star Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the knowledge of F-Star, threatened, which seeks to revoke or limit any F-Star Permit. F-Star has made available to Company all material F-Star Permits.
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(c) To the knowledge of F-Star, the F-Star Companies and Persons acting in concert with and on behalf of F-Star:
(i) have not used in any capacity the services of any individual or Entity debarred, excluded, or disqualified under 21 U.S.C. Section 335a, 42 U.S.C. Section 1320a-7 or 21 C.F.R. Section 312.70, or any similar Legal Requirements in any jurisdiction; and
(ii) have not been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment, exclusion, or disqualification under 21 U.S.C. Section 335a, 42 U.S.C. Section 1320a-7 or 21 C.F.R. Section 312.70 or any similar Legal Requirements in any jurisdiction.
(d) None of the F-Star Companies and, to the knowledge of F-Star, no Representative of any F-Star Company or Person acting in concert with or on behalf of the F-Star Companies, or any officers, employees or Representatives of the same, has with respect to any product that is manufactured, tested, distributed, held or marketed by or on behalf of any of the F-Star Companies made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities policy that is set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Body to invoke any similar policy.
(e) None of the F-Star Companies and, to the knowledge of F-Star, no Representative of any F-Star Company or Person acting in concert with or on behalf of the F-Star Companies, or any officers, employees or Representatives of the same with respect to any matter relating to any of the F-Star Companies, has: (i) used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity; (ii) made any unlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns or violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, the U.K. Bribery Act of 2010 or any other analogous legislation in any jurisdiction, as amended; or (iii) made any other unlawful payment.
(f) At no time since January 1, 2018 has any of the F-Star Companies received written notice that any Governmental Body or institutional review board has commenced, or threatened to initiate, any proceeding seeking the suspension or termination of preclinical or clinical research with respect to any product candidate being researched or developed by or on behalf of any of the F-Star Companies, including any action regarding any investigator participating in any such clinical research. F-Star has, prior to the execution of this Agreement, provided or made available to Company all information about material adverse drug experiences since January 1, 2018 obtained or otherwise received by any of the F-Star Companies from any source, in the United States or outside the United States, related to its respective current products or product candidates, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers relating to any product or product candidate manufactured, tested, distributed, held or marketed by any of the F-Star Companies or any of their licensees in the possession of any of the F-Star Companies (or to which any of them has access). F-Star has disclosed to Company all material information known by F-Star with respect to the safety and efficacy of the F-Star products and product candidates from nonclinical and/or clinical studies. Each of the F-Star Companies has filed all annual and periodic reports, amendments and safety reports required to be made by an F-Star Company for any F-Star product or service required to be made to the FDA or any other Governmental Body.
(g) All preclinical and clinical studies relating to product or product candidates, conducted by or on behalf of the F-Star Companies have been, or are being, conducted in all material respects in compliance with the applicable requirements of the FDAs Good Laboratory Practice and Good Clinical Practice requirements, including regulations codified at 21 C.F.R. Parts 50, 54, 56, 58, and 312, as amended from time to time, and all applicable similar requirements in other jurisdictions, including all requirements relating to protection of human
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subjects participating in any such clinical studies; provided, however, that the foregoing representation and warranty is made (i) only to F-Stars knowledge with respect to clinical and preclinical studies conducted by any third party on behalf of the F-Star Companies and (ii) specifically excludes preclinical studies that were not designed to be conducted in accordance with Good Laboratory Practice. No F-Star Company has received any notices or correspondence from the FDA or any other Governmental Body requiring the termination, suspension or material modification of any preclinical study or clinical trial after initiation thereof by or on behalf of an F-Star Company.
(h) Each of the F-Star Companies has filed with the FDA, any other Governmental Body, and any institutional review board, all material required notices, supplemental applications, and annual or other reports, including adverse experience reports, with respect to each investigational new drug application or any comparable foreign regulatory application, related to the manufacture, testing, study, or sale of any of its products or product candidates, as applicable.
(i) None of the F-Star Companies is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Body. None of the F-Star Companies is subject to any investigation that is pending or, to the knowledge of F-Star, that has been threatened, in each case by (i) the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.) or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Federal Civil False Claims Act (31 U.S.C. §3729), or any similar investigation that is pending or, to the knowledge of F-Star, that has been threatened by any other Governmental Body pursuant to any other applicable Legal Requirements. Each of the F-Star Companies has complied in all material respects with all applicable security and privacy standards related to protected health information under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, as amended from time to time. No F-Star Company has experienced any material security breach or other incident resulting in the unauthorized access to, use of, or disclosure of protected health information. Each F-Star Company is, and has at all times since January 1, 2017 been, in compliance with all Legal Requirements and contractual obligations regarding the privacy, protection, storage, use and disclosure of Personal Data collected by such F-Star Company, except as would not, individually or in the aggregate, have an F-Star Material Adverse Effect.
(j) None of the F-Star Companies has received any FDA Form 483s, warning letters, untitled letters, cyber letters, notices of violation, consent decrees, notices of investigation, indictments, sentencing memoranda, plea agreements, court orders, target or no-target letters, proceedings, reviews (including data integrity reviews) or other notice of enforcement action from a Governmental Body.
2.9 Legal Proceedings; Orders.
(a) Except as set forth in Part 2.9(a) of the F-Star Disclosure Schedule, during the three (3)-year period prior to the date hereof there has not been, and there is no pending, or threatened in writing, Legal Proceeding and, to the knowledge of F-Star, no Person has threatened to commence any Legal Proceeding: (i) that involves any of the F-Star Companies, any business of any of the F-Star Companies or any of the assets owned, leased or used by any of the F-Star Companies; or (ii) that challenges, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, any of the Contemplated Transactions, in each case as a claimant, defendant or in any other capacity. None of the Legal Proceedings identified in Part 2.9(a) of the F-Star Disclosure Schedule has had or, if adversely determined, would have or result in, either individually or in the aggregate, an F-Star Material Adverse Effect. To the knowledge of F-Star, no event has occurred, and no claim, dispute or other condition or circumstance exists, that would reasonably be expected to give rise to or serve as a basis for the commencement of any Legal Proceeding of the type described in clause (i) or clause (ii) of the first sentence of this Section 2.9(a).
(b) There is no Order to which any of the F-Star Companies, or any of the assets owned or used by any of the F-Star Companies, is subject. To the knowledge of F-Star, no officer or other key employee of any of the F-Star Companies is subject to any Order that prohibits such officer or other employee from engaging in or continuing any conduct, activity or practice relating to the business of any of the F-Star Companies.
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(c) No F-Star Company is unable to pay its debts, within the meaning of section 123 IA 1986 (without any requirement to prove any matter referred to in that section to the satisfaction of the court) or any other legislation analogous to IA 1986 that is applicable to an F-Star Company in its jurisdiction of incorporation, and no F-Star Company has stopped or suspended payment of its debts as they fall due.
2.10 Brokers and Finders Fees. Except as set forth on Part 2.10 of the F-Star Disclosure Schedule, no broker, finder or investment banker is entitled to any brokerage, finders or other fee or commission in connection with the Contemplated Transactions based upon arrangements made by or on behalf of any of the F-Star Companies. F-Star has furnished to Company accurate and complete copies of all agreements under which any such fees, commissions or other amounts have been paid or may become payable and all indemnification and other agreements related to the engagement of any Persons listed on Part 2.10 of the F-Star Disclosure Schedule.
(a) Part 2.11(a) of the F-Star Disclosure Schedule sets forth, as of the date hereof, a complete and accurate list of each material plan, program, policy, Contract or other arrangement providing for employment, compensation, retirement, pension, deferred compensation, severance, separation, relocation, termination pay, performance awards, bonus, incentive compensation, stock option, stock purchase, stock bonus, phantom stock, stock appreciation right, other equity-based award, supplemental retirement, profit sharing, material fringe benefits, cafeteria benefits, medical benefits, life insurance, disability benefits, accident benefits, salary continuation, accrued leave, vacation, or other material employee benefits, whether written or unwritten, and each other employee benefit plan within the meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (ERISA), in each case, for current, retired or former employees, directors or consultants of any F-Star Company, which is sponsored, maintained, contributed to, or required to be contributed to by any F-Star Company or with respect to which an F-Star Company has any material Liability (collectively, the F-Star Employee Plans).
(b) F-Star has made available to Company true and complete copies of each F-Star Employee Plan and all material related plan documents, including trust documents, plan amendments, Insurance Policies or contracts, summary plan descriptions, and compliance and nondiscrimination tests (including 401(k) and 401(m) tests) for the last three plan years. With respect to each F-Star Employee Plan that is subject to ERISA reporting requirements, F-Star has made available to Company copies of the Form 5500 reports filed by or on behalf of an F-Star Company with respect to any F-Star Employee Plan for the most recent plan year. Each F-Star Employee Plan that is intended to be qualified under Section 401(a) of the Code has received a favorable determination letter from the Internal Revenue Service that remains effective or is entitled to rely on a favorable opinion letter from the Internal Revenue Service on the form of such F-Star Employee Plan, and to F-Stars knowledge, nothing has occurred since the issuance of each such letter that would reasonably be expected to cause the loss of the tax-qualified status of any F-Star Employee Plan subject to Section 401(a) of the Code. F-Star has made available to Company the most recent Internal Revenue Service determination or opinion letter issued with respect to each such F-Star Employee Plan, as applicable.
(c) Each F-Star Employee Plan has been maintained and administered in all material respects in accordance with its terms and in material compliance with the requirements prescribed by applicable Legal Requirements (including, where applicable, ERISA and the Code). No F-Star Employee Plan promises or provides retiree medical or other retiree welfare benefits to any person, except to the extent required by Section 4980B of the Code or any similar state or non-U.S. Legal Requirement. With respect to each F-Star Employee Plan, no reportable event within the meaning of Section 4043 of ERISA (excluding any such event for which the thirty (30) day notice requirement has been waived under the regulations to Section 4043 of ERISA) has occurred, nor has any event described in Section 4062, 4063 or 4041 or ERISA occurred, in each case, that could reasonably result in material Liability to an F-Star Company. No suit or material administrative proceeding or action is pending, or to the knowledge of F-Star is threatened, against or with respect to any F-Star Employee Plan, including any audit by the Internal Revenue Service or the United States Department of Labor (other than routine claims for benefits arising under such plans).
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(d) Neither F-Star nor any ERISA Affiliate of F-Star has ever maintained, established, sponsored, participated in or contributed to, or is or has been obligated to contribute to, or otherwise incurred any Liability under, any multiemployer plan (as defined in Section 3(37) of ERISA) or any pension plan (as defined in Section 3(2) of ERISA) subject to Title IV of ERISA or Section 412 of the Code.
(e) Other than as specifically contemplated by this Agreement or as set forth in Part 2.11(e) of the F-Star Disclosure Schedule, the consummation of the Acquisition will not, either alone or in combination with another event, (i) entitle any current or former employee or other service provider of any F-Star Company to severance benefits or any other payment (including golden parachute or bonus payments); (ii) accelerate the time of payment or vesting of any such payments or benefits or increase the amount of compensation or benefits due any such employee or service provider; (iii) result in the forgiveness of any indebtedness; or (iv) result in any obligation to fund future benefits under any F-Star Employee Plan. No benefit payable or that may become payable by F-Star in connection with the Contemplated Transactions or as a result of or arising under this Agreement (either alone or in combination with another event) is reasonably likely to constitute an excess parachute payment (as defined in Section 280G(b)(1) of the Code) subject to the imposition of an excise Tax under Section 4999 of the Code or the deduction for which would be disallowed by reason of Section 280G of the Code.
(f) On or prior to the date hereof, the F-Star Companies have taken all actions necessary or advisable to assure that upon the consummation of the transactions contemplated by Section 6.15, the Company shall acquire, or F-Star shall have the right to acquire on the Companys behalf, all F-Star Ordinary Shares issuable upon the exercise of the F-Star Options or issuable upon the vesting of the F-Star RSUs that are not exchanged for Replacement EIP Options or Replacement EIP RSUs, as applicable, in each case free and clear of any Encumbrance.
2.12 Title to Assets; Real Property. Except as set forth on Part 2.12 of the F-Star Disclosure Schedule, the F-Star Companies own, and have good, valid and marketable title to, all material tangible assets purported to be owned by them, including all material tangible assets reflected in the books and records of the F-Star Companies as being owned by the F-Star Companies. All of said assets are owned by the F-Star Companies free and clear of any Encumbrances, except for (i) any lien for current Taxes not yet due and payable or for Taxes that are being contested in good faith and for which adequate reserves have been made on the F-Star Financials, (ii) liens that have arisen in the ordinary course of business and that do not (individually or in the aggregate) materially detract from the value of the assets subject thereto or materially impair the operations of any F-Star Company, and (iii) Encumbrances described in Part 2.12 of the F-Star Disclosure Schedule. The F-Star Companies are the lessees of, and hold valid leasehold interests in, all assets purported to have been leased by them, including all assets reflected in the books and records of the F-Star Companies as being leased to the F-Star Companies, and the F-Star Companies enjoy undisturbed possession of such leased assets. The F-Star Companies do not own and have never owned any real property or any interest in real property, except for the leaseholds created under the real property leases identified in Part 2.12 of the F-Star Disclosure Schedule. Part 2.12 of the F-Star Disclosure Schedule sets forth a complete and accurate list of all real property leases to which any F-Star Company is a party, which are each in full force and effect, and with no existing material default thereunder.
2.13 Environmental Matters. Each F-Star Company is in compliance with all applicable Environmental Laws, which compliance includes the possession by F-Star of all permits and other authorizations required under applicable Environmental Laws and compliance with the terms and conditions thereof, except where the failure to be in compliance would not, individually or in the aggregate, have an F-Star Material Adverse Effect. Since January 1, 2017, no F-Star Company has received any written notice or other communication (in writing or otherwise), whether from a Governmental Body, citizens group, employee or otherwise, that alleges that any F-Star Company is not in material compliance with any Environmental Law, and, to the knowledge of F-Star, there are no circumstances existing as of the date hereof that would prevent or interfere with any F-Star Companys material compliance with any Environmental Law in the future. To the knowledge of F-Star: (i) no current or prior owner of any property leased or controlled by any F-Star Company has received any written notice or other communication relating to property owned or leased at any time by any F-Star Company, whether from a Governmental Body, citizens group, employee or otherwise, that alleges that such current or prior owner
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or any F-Star Company is not in compliance with or has violated any Environmental Law relating to such property and (ii) no F-Star Company has any material liability under any Environmental Law.
(a) The document in the Part 2.14(a) Folder in the F-Star Data Room sets forth a true, complete and correct list showing anonymized, non-identifiable details of all employees of the F-Star Companies, including whether classified as exempt or non-exempt for wage and hour purposes, business location, and 2019 actual compensation.
(b) There are no agreements or other arrangements between the F-Star Companies and any trade union or other body representing employees and no notices have been served under the Information and Consultation of Employee Regulations 2004.
(c) The F-Star Companies have in all material respects in relation to all present and former F-Star Personnel (i) complied with Employment Legislation, (ii) maintained adequate up-to-date records, and retained records regarding their service and engagement, their hours of work and rest breaks, their right to work and, where F-Star Personnel are sponsored by any F-Star Company in accordance with immigration legislation, their contact details and absence records, and (iii) complied with all contractual obligations towards F-Star Personnel.
(a) Part 2.15 of the F-Star Disclosure Schedule lists each of the following Contracts in effect as of the date of this Agreement to which any F-Star Company is a party or by which any F-Star Company is bound:
(i) any Contract incorporating or relating to any guaranty, any warranty, any sharing of Liabilities or any indemnity not entered into in the ordinary course of business, including any indemnification agreements between an F-Star Company and any of its officers or directors;
(ii) any Contract imposing any material restriction on the right or ability of any F-Star Company: (A) to compete with any other Person; (B) to acquire any product or other asset or any services from any other Person; (C) to develop, sell, supply, distribute, offer, support or service any product or any technology or other asset to or for any other Person; (D) to perform services for any other Person; or (E) to otherwise transact business with any other Person;
(iii) any Contract relating to the disposition or acquisition of any material interest in, or any material amount of, property or assets of any F-Star Company, other than in the ordinary course of business, or any ownership interest in any corporation, partnership, joint venture or other business enterprise;
(iv) any Contract relating to the borrowing of money or extension of credit, except for Contracts relating to indebtedness in an amount not exceeding $250,000 in the aggregate;
(v) any joint marketing or collaboration Contract;
(vi) any Contract that gives rise to any material payment or benefit as a result of the performance of this Agreement;
(vii) any Contract that provides for: (A) any right of first refusal, right of first negotiation, right of first notification or similar right with respect to any securities or assets of any F-Star Company; or (B) any no shop provision or similar exclusivity provision with respect to any securities or assets of any F-Star Company;
(viii) any Contract providing any severance or change-in-control payment or benefit to any officer, director or employee of any F-Star Company;
(ix) any Contract with any Governmental Body that is material to the business or operations of the F-Star Companies;
(x) any interested party Contracts;
(xi) any Contract containing any royalty, dividend or similar arrangement based on the revenues or profits of the Company or any of its Subsidiaries;
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(xii) any Contract for leased real property;
(xiii) any Contract with any financial advisor, broker, finder, investment bank or other Person, providing advisory services;
(xiv) any Contract that is not terminable at will with no more than ninety (90) days prior notice to the other party (with no penalty or payment) by F-Star and (A) which involves payment or receipt by any F-Star Company after the date of this Agreement under any such Contract of more than $250,000 in the aggregate, or obligations after the date of this Agreement in excess of $250,000 in the aggregate, or (B) that is material to the business or operations of the F-Star Companies; or
(xv) any Contract not entered into in the ordinary course of business that contemplates or involves the payment or delivery of cash or other consideration in an amount or having a value in excess of $250,000 in the aggregate, or contemplates or involves the performance of services having a value in excess of $250,000 in the aggregate, other than any arrangement or agreement expressly contemplated by or provided for under this Agreement.
(b) F-Star has made available to Company an accurate and complete copy of each Contract listed or required to be listed in Part 2.15 of the F-Star Disclosure Schedule (any such Contract, an F-Star Contract). There are no F-Star Contracts that are not in written form. No F-Star Company and, to F-Stars knowledge, no other party to an F-Star Contract has breached or violated in any material respect or materially defaulted under, or received notice that it has breached, violated or defaulted under, any of the terms or conditions of any of the F-Star Contracts. To the knowledge of F-Star, no event has occurred, and no circumstance or condition exists, that (with or without notice or lapse of time or both) would reasonably be expected to: (i) result in a violation or breach in any material respect of any of the provisions of any F-Star Contract; (ii) give any Person the right to declare a default in any material respect under any F-Star Contract; (iii) give any Person the right to receive or require a rebate, chargeback, penalty or change in delivery schedule under any F-Star Contract; (iv) give any Person the right to accelerate the maturity or performance of any F-Star Contract; or (v) give any Person the right to cancel, terminate or modify any F-Star Contract. The consummation of the Acquisition will not (either alone or upon the occurrence of additional acts or events) result in any material payment or payments becoming due from any F-Star Company to any Person under any F-Star Contract or give any Person the right to terminate or alter the provisions of any F-Star Contract. No Person is renegotiating any material amount paid or payable to any F-Star Company under any F-Star Contract or any other material term or provision of any F-Star Contract. Each F-Star Contract is valid, binding, enforceable and in full force and effect, and will continue to be valid, binding, enforceable and in full force and effect following the Closing and the consummation of the Acquisition, except as enforceability may be limited by bankruptcy and other similar laws and general principles of equity.
2.16 Books and Records. The minute books of the F-Star Companies have been made available to Company and contain accurate summaries, in all material respects, of all meetings of directors (or committees thereof) and shareholders or actions by written consent since January 1, 2018. Each of the share certificate books, registers of shareholders and other corporate registers of the F-Star Companies comply in all material respects with the provisions of all applicable Legal Requirements and are complete and accurate in all material respects.
(a) Each of the F-Star Companies insurance policies (including, as applicable, fire, theft, casualty, general liability, workers compensation, business interruption, environmental, product liability, clinical trial and automobile insurance policies and bond and surety arrangements, collectively Insurance Policies) are in full force and effect on the date hereof and are maintained with reputable companies against loss relating to the business, operations and properties and such other risks as companies engaged in similar business as the F-Star Companies would, in accordance with good business practice, customarily insure. All premiums due and payable under such Insurance Policies have been paid on a timely basis and each F-Star Company is in compliance in all material respects with all other terms thereof. True, complete and correct copies of such Insurance Policies have been made available to Company.
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(b) Except as set forth on Part 2.17(b) of the F-Star Disclosure Schedule, there are no material claims pending, under any Insurance Policy to which any F-Star Company is a party, as to which coverage has been questioned, denied or disputed. All material claims thereunder have been filed in a due and timely fashion and since January 1, 2017 no F-Star Company has been refused insurance for which it has applied or had any policy of insurance terminated (other than at its request), nor has any F-Star Company received notice from any insurance carrier that: (i) such insurance will be canceled or that coverage thereunder will be reduced or eliminated; or (ii) premium costs with respect to such insurance will be increased, other than premium increases in the ordinary course of business applicable on their terms to all holders of similar policies.
2.18 Government Contracts. F-Star has not been suspended or debarred from bidding on contracts with any Governmental Body, and, to the knowledge of F-Star, no such suspension or debarment has been initiated or threatened. The consummation of the Contemplated Transactions will not result in any such suspension or debarment of F-Star (assuming that no such suspension or debarment will result solely from the identity of Company).
2.19 Interested Party Transactions. Except as set forth on Part 2.19 of the F-Star Disclosure Schedule, no event has occurred since January 1, 2018 that would be required to be reported by F-Star as a Certain Relationship or Related Transaction pursuant to Item 404 of Regulation S-K, if F-Star were required to report such information in periodic reports pursuant to the Exchange Act.
2.20 Disclosure; Company Information. None of the information supplied or to be supplied by or on behalf of F-Star for inclusion or incorporation by reference in the Registration Statement will, at the time the Registration Statement is filed with the SEC, at any time it is amended or supplemented, or at the time it becomes effective under the Securities Act, contain any statement that, in light of the circumstances under which it was made, is false or misleading with respect to any material fact or omit to state any material fact necessary in order to correct any statement of a material fact in any earlier communication with respect to the solicitation of proxies for the Company Stockholders Meeting which has become false or misleading. None of the information supplied or to be supplied by or on behalf of F-Star for inclusion or incorporation by reference in the Proxy Statement will, at the time the Proxy Statement is first mailed to the Company Stockholders or at the time of the Company Stockholders Meeting, contain any statement that, in light of the circumstances under which it was made, is false or misleading with respect to any material fact or omit to state any material fact necessary in order to correct any statement of a material fact in any earlier communication with respect to the solicitation of proxies for the Company Stockholders Meeting which has become false or misleading. Notwithstanding the foregoing, no representation is made by F-Star with respect to the information that has been or will be supplied by any of the Acquiring Companies, any Seller or any of their respective Representatives for inclusion in the Proxy Statement.
2.21 Anti-Takeover Statutes Not Applicable. The board of directors of F-Star has taken all actions so that no takeover statute or similar Legal Requirement related to business combinations applies or purports to apply to the execution, delivery or performance of this Agreement or to the consummation of the Contemplated Transactions.
2.22 Ownership of Company Capital Stock. None of the F-Star Companies own, directly or indirectly, beneficially or of record, any shares of Company Capital Stock or any other economic interest (through derivative securities or otherwise) in, Company. Other than as contemplated by this Agreement, none of the F-Star Companies is, nor at any time during the last three (3) years has it been, an interested stockholder of Company within the meaning of Section 203 of the General Corporation Law of the State of Delaware (Delaware Law).
2.23 F-Star Pre-Closing Financing. True and complete executed counterparts of the Equity Commitment Letters have been delivered to Company prior to the execution and delivery of this Agreement and F-Star will deliver to Company Additional Equity Commitment Letters promptly after the execution and delivery thereof. The Equity Commitment Letters are in full force and effect as of the date hereof and any Additional Equity Commitment Letters will be in full force and effect as of their date. The Equity Commitment Letters and all Additional Equity Commitment Letters will be in full force and effect at Closing. No amendment, modification or waiver of the Equity Commitment Letters has occurred prior to the date hereof. Pursuant to the
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terms of the Equity Commitment Letters and any Additional Equity Commitment Letters, each Investor or Additional Investor, as applicable, will be legally required to enter into the Subscription Agreement and to consummate the F-Star Pre-Closing Financing on the terms and conditions set forth in the Subscription Agreement. Neither F-Star nor, to the knowledge of F-Star, any of its Affiliates has entered into any agreement, side letter or other arrangement relating to the F-Star Pre-Closing Financing other than as set forth in the F-Star Pre-Closing Financing Agreements or the Equity Commitment Exchange described in Section 6.30. Each Equity Commitment Letter has been, and each Additional Equity Commitment Letter and the Subscription Agreement will be, duly authorized, executed and delivered by F-Star and, to F-Stars knowledge, the other parties thereto, and each Equity Commitment Letter constitutes, and each Additional Equity Commitment Letter and the Subscription Agreement will constitute, a valid and binding obligation of F-Star and, to the knowledge of F-Star, of each other party thereto, enforceable in accordance with their respective terms subject to applicable bankruptcy, insolvency, reorganization, moratorium, or other similar Legal Requirements relating to creditors rights and general principles of equity. No event has occurred which, with or without notice, lapse of time or both, would constitute a breach or default on the part of F-Star or, to the knowledge of F-Star, any other party thereto, under the F-Star Pre-Closing Financing Agreements. To the knowledge of F-Star, no party thereto will be unable to satisfy on a timely basis any term of the F-Star Pre-Closing Financing Agreements. There are no conditions precedent related to the consummation of the F-Star Pre-Closing Financing, other than the satisfaction or waiver of the conditions expressly set forth in the Equity Commitment Letters, the Additional Equity Commitment Letters, if any, and the Subscription Agreement. To the knowledge of F-Star, the proceeds of the F-Star Pre-Closing Financing will be made available to F-Star prior to the Closing.
2.24 Exclusivity of Representations; Reliance.
(a) Except as expressly set forth in this Article 2, neither F-Star nor any Person on behalf of F-Star has made, nor are any of them making, any representation or warranty, written or oral, express or implied, at law or in equity, including with respect to merchantability or fitness for any particular purpose, in respect of F-Star or its business in connection with the Contemplated Transactions, including any representations or warranties about the accuracy or completeness of any information or documents previously provided (including with respect to any financial or other projections therein), and any other such representations and warranties are hereby expressly disclaimed.
(b) F-Star acknowledges and agrees that, except for the representations and warranties of Company set forth in Article 3, neither F-Star nor its Representatives is relying on any other representation or warranty of Company, or any other Person made outside of Article 3, including regarding the accuracy or completeness of any such other representations or warranties or the omission of any material information, whether express or implied, in each case with respect to the Contemplated Transactions.
REPRESENTATIONS AND WARRANTIES OF COMPANY
Company represents and warrants to F-Star and Sellers as follows (it being understood that each representation and warranty contained in this Article 3 is subject to: (a) the exceptions and disclosures set forth in the part or subpart of the Company Disclosure Schedule corresponding to the particular Section or subsection in this Article 3 in which such representation and warranty appears; (b) any exceptions or disclosures explicitly cross- referenced in such part or subpart of the Company Disclosure Schedule by reference to another part or subpart of the Company Disclosure Schedule; and (c) any exception or disclosure set forth in any of the Companys SEC Documents and publicly available on the SECs Electronic Data Gathering Analysis and Retrieval system (but (i) solely to the extent that any information is reasonably apparent from a review of such SEC Documents, (ii) without giving effect to any amendment thereof filed with, or furnished to the SEC on or after the date hereof and (iii) excluding any disclosures contained under the heading Risk Factors and any disclosure of risks included in any forward-looking statements disclaimer or in any other section to the extent they are forward-looking statements or cautionary, predictive or forward-looking in nature) or other part or
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subpart of the Company Disclosure Schedule to the extent it is reasonably apparent from the wording of such exception or disclosure that such exception or disclosure qualifies such representation and warranty):
3.1 Organization and Qualification; Charter Documents.
(a) Part 3.1(a) of the Company Disclosure Schedule identifies each Subsidiary of Company and indicates its jurisdiction of organization. No Acquiring Company owns any capital stock of, or any equity interest of any nature in, any other Entity, other than the Entities identified in Part 3.1(a) of the Company Disclosure Schedule. None of the Acquiring Companies has agreed or is obligated to make, or is bound by any Contract under which it may become obligated to make, any future investment in or capital contribution to any other Entity.
(b) Each of the Acquiring Companies is a corporation duly organized and validly existing under the laws of the jurisdiction of its incorporation and has all necessary corporate power and authority: (i) to conduct its business in the manner in which its business is currently being conducted; (ii) to own and use its assets in the manner in which its assets are currently owned and used; and (iii) to perform its obligations under all Contracts by which it is bound, except where the failure to be so qualified and in good standing would not, individually or in the aggregate, have a Company Material Adverse Effect. The Organizational Documents of each Acquiring Company, copies of which have previously been made available to F-Star, are true, correct and complete copies of such documents as currently in effect, and Company is not in violation of any provision thereof in any material respect.
(c) Each of the Acquiring Companies (in jurisdictions that recognize the following concepts) is qualified to do business as a foreign corporation, and is in good standing, under the laws of all jurisdictions where the nature of its business requires such qualification, except where the failure to be so qualified and in good standing would not, individually or in the aggregate, have a Company Material Adverse Effect.
(a)The authorized capital stock of Company consists of 200,000,000 shares of Company Common Stock, of which 17,248,545 shares of Company Common Stock are issued and outstanding as of the close of business on the day prior to the date hereof, and 10,000,000 shares of preferred stock, par value $0.0001 (Company Preferred Stock and, together with the Company Common Stock, collectively Company Capital Stock) , none of which are issued and outstanding as of the close of business on the day prior to the date hereof. No shares of capital stock are held in Companys treasury. All outstanding shares of Company Common Stock are duly authorized, validly issued, fully paid and non-assessable and were issued in compliance with all applicable Legal Requirements.
(b) As of the date hereof, Company had reserved (i) an aggregate of 3,450,000 shares of Company Common Stock for issuance under the Company Option Plan, under which options were outstanding for an aggregate of 1,606,275 shares and Company RSUs were outstanding for an aggregate of 534,000 shares and (ii) an additional 1,927,124 shares of Company Common Stock for issuance to holders of warrants to purchase Company Common Stock upon their exercise. All shares of Company Common Stock subject to issuance as aforesaid, upon issuance on the terms and conditions specified in the instruments pursuant to which they are issuable, would be duly authorized, validly issued, fully paid and non-assessable. Part 3.2(b) of the Company Disclosure Schedule lists each outstanding Company Option and Company RSU, the name of the holder of such option or unit, the number of shares subject to such option or unit, the exercise price of such option, the vesting schedule and termination date of such option or unit, and whether the exercisability of such option or vesting or settlement of such unit will be accelerated in any way by the Contemplated Transactions. Each Company Option was granted with an exercise price not less than the fair market value of a share of Company Common Stock on the date such option was approved by the board of directors of Company or an authorized committee thereof. All outstanding options to purchase Company Common Stock were granted under the Company Option Plan.
(c) As of the date hereof, Company has reserved an aggregate of 1,927,124 shares of Company Common Stock for issuance under Company Warrants. Part 3.2(c) of the Company Disclosure Schedules lists for each outstanding Company Warrant, (i) the name of the holder of such Company Warrant, (ii) the issuance date
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and expiration date thereof, (iii) the grant date and expiration date thereof, (iv) the vesting schedule, and (v) the exercise price per share and the number of shares of Company Common Stock underlying such Company Warrant to date.
(d) Except as set forth in Part 3.2(d) of the Company Disclosure Schedule, (i) none of the outstanding shares of Company Common Stock are entitled or subject to any preemptive right, right of repurchase or forfeiture, right of participation, right of maintenance or any similar right; (ii) none of the outstanding shares of Company Common Stock are subject to any right of first refusal in favor of Company; (iii) there are no outstanding bonds, debentures, notes or other indebtedness of the Acquiring Companies having a right to vote on any matters on which the Company Stockholders have a right to vote; (iv) there is no Contract to which the Acquiring Companies are a party relating to the voting or registration of, or restricting any Person from purchasing, selling, pledging or otherwise disposing of (or from granting any option or similar right with respect to), any shares of Company Common Stock; and (v) none of the Acquiring Companies is under any obligation, or is bound by any Contract pursuant to which it may become obligated, to repurchase, redeem or otherwise acquire any outstanding shares of Company Common Stock or other securities, and there are no shares of Company Common Stock outstanding that are subject to a risk of forfeiture or other similar condition under any applicable restricted stock purchase agreement. Part 3.2(c) of the Company Disclosure Schedule accurately and completely lists all repurchase rights held by Company with respect to shares of Company Common Stock (including shares issued pursuant to the exercise of stock options) and specifies each holder of such shares of Company Common Stock, the date of purchase and number of such shares, the purchase price paid by such holder, the vesting schedule under which such repurchase rights lapse, and whether the holder of such shares filed an election under Section 83(b) of the Code with respect to such shares within thirty (30) days of purchase.
(e) There is no Company Stockholder that is an Affiliate of any officer or director of Company that is not listed on Schedule II.
3.3 Authority; Non-Contravention; Approvals.
(a) Company has the requisite corporate power and authority to enter into this Agreement and, subject to Company Stockholder Approval, to perform its obligations hereunder and to consummate the Contemplated Transactions. The execution and delivery of this Agreement by Company, the performance by Company of its obligations hereunder and the consummation by Company of the Contemplated Transactions have been duly authorized by all necessary corporate action on the part of Company, subject only to Company Stockholder Approval. The Company Stockholder Approval Threshold is the only vote of the holders of any class or series of Company Common Stock necessary to approve the Company Stockholder Approval Matters (collectively, Company Stockholder Approval). Except for Company Stockholder Approval, no other corporate proceeding on the part of Company is necessary to authorize the adoption, execution, delivery and performance of this Agreement or to consummate the Acquisition. This Agreement has been duly executed and delivered by Company and, assuming the due authorization, execution and delivery by F-Star and Sellers, constitutes the valid and binding obligation of Company, enforceable in accordance with its terms, subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other laws affecting creditors rights generally and general principles of equity.
(b) Companys board of directors, by resolutions duly adopted by vote at a meeting of all directors of Company duly called and held and, as of the date hereof, not subsequently rescinded or modified in any way, has, as of the date hereof (i) approved, adopted and declared advisable this Agreement and the Acquisition, and determined that this Agreement and the Contemplated Transactions, including the Acquisition, are fair to and in the best interests of the Company Stockholders, and (ii) approved the Company Stockholder Approval Matters that require board approval and resolved to recommend that the Company Stockholders approve the Company Stockholder Approval Matters, and directed that such matters be submitted for consideration of the Company Stockholders.
(c) The execution and delivery of this Agreement by Company does not, and the performance of this Agreement by Company will not, (i) conflict with or violate the Organizational Documents of any Acquiring Company, (ii) subject to obtaining the Company Stockholder Approval and compliance with the requirements set
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forth in Section 3.3(d) below, conflict with or violate any Legal Requirement applicable to the Acquiring Companies or by which its or any of their respective properties are bound or affected, or (iii) require an Acquiring Company to make any filing with or give any notice to a Person or to obtain any Consent from a Person, or result in any breach of or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or impair Companys rights or alter the rights or obligations of any third party under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of a lien or encumbrance on any of the properties or assets of the Acquiring Companies pursuant to, any Company Contract to which an Acquiring Company is a party or by which any Acquiring Company or any of its properties are bound or affected (except, for purposes of this clause (iii), as would not, individually or in the aggregate, have a Company Material Adverse Effect).
(d) No consent, approval, order or authorization of, or registration, declaration or filing with, any Governmental Body is required by or with respect to Company in connection with the execution and delivery of this Agreement or the consummation of the Contemplated Transactions, except for (i) the filings contemplated by Section 6.4(a), (ii) the filing of Current Reports on Form 8-K with the SEC within four (4) Business Days after the execution of this Agreement and the Closing Date, and (iii) such approvals as may be required under applicable state securities or blue sky laws or the rules and regulations of Nasdaq.
3.4 Anti-Takeover Statutes Not Applicable. Subject to the accuracy of F-Stars representations in Section 2.22 and each Sellers representations in Section 4.5, the board of directors of Company has taken all actions so that no state takeover statute or similar Legal Requirement, or, in the case of Section 203 of Delaware Law, the restrictions on business combinations provided for therein, applies or purports to apply to the execution, delivery or performance of this Agreement or to the consummation of the Contemplated Transactions.
3.5 SEC Filings; Company Financial Statements; No Undisclosed Liabilities.
(a) All Company SEC Documents have been timely filed and, as of the time a Company SEC Document was filed with the SEC (or, if amended or superseded by a filing prior to the date hereof, then on the date of such filing): (i) each of the Company SEC Documents complied in all material respects with the applicable requirements of the Securities Act or Exchange Act (as the case may be) and (ii) none of the Company SEC Documents contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. Each of the certifications and statements relating to Company SEC Documents required by Rule 13a-14 or 15d-14 under the Exchange Act or 18 U.S.C. §1350 (Section 906 of the Sarbanes-Oxley Act) is accurate and complete, and complied as to form and content with all applicable Legal Requirements in effect at the time such certification was filed with or furnished to the SEC by Company. As used in this Section 3.5, the term file and variations thereof will be broadly construed to include any manner in which a document or information is furnished, supplied or otherwise made available to the SEC.
(b) As of the date of this Agreement, Company has timely responded to all comment letters of the staff of the SEC relating to the Company SEC Documents, and the SEC has not advised Company that any final responses are inadequate, insufficient or otherwise non-responsive. Company has made available to F-Star true, correct and complete copies of all comment letters, written inquiries and enforcement correspondence between the SEC, on the one hand, and Company and any of its Subsidiaries, on the other hand, occurring since January 1, 2018. To the knowledge of Company, as of the date of this Agreement, none of the Company SEC Documents is the subject of ongoing SEC review or outstanding SEC comment.
(c) The Company maintains disclosure controls and procedures required by Rule 13a-15 or 15d-15 under the Exchange Act. Such disclosure controls and procedures are designed to ensure that all material information concerning Company required to be disclosed by Company in the reports that it is required to file, submit or furnish under the Exchange Act is recorded, processed, summarized and reported on a timely basis to the individuals responsible for the preparation of such reports. The Company maintains a system of internal controls over financial reporting which is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with United
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States generally accepted accounting principles (GAAP), in each case, with respect to the Acquiring Companies, taken as a whole.
(d) The financial statements (including any related notes) contained or incorporated by reference in the Company SEC Documents (the Company Financials): (i) complied as to form in all material respects with the published rules and regulations of the SEC applicable thereto; (ii) were prepared in accordance with GAAP applied on a consistent basis throughout the periods involved (except as may be indicated in the notes to such financial statements or, in the case of unaudited financial statements, as permitted the SEC, and except that the unaudited financial statements may not contain footnotes and are subject to normal and recurring year-end adjustments that are not reasonably expected to be material in amount) applied on a consistent basis unless otherwise noted therein throughout the periods indicated; and (iii) fairly present, in all material respects, the consolidated financial position of Company as of the respective dates thereof and the consolidated results of operations and cash flows of Company for the periods covered thereby. The unaudited balance sheet of Company as of March 31, 2020 is hereinafter referred to as the Company Balance Sheet.
(e) As of the date of this Agreement, no Acquiring Company has any Liabilities, except for (i) Liabilities reflected on the Company Balance Sheet, (ii) Liabilities incurred since the date of the Company Balance Sheet in the ordinary course of business consistent with past practices and which are not in excess of $250,000, in the aggregate, (iii) Liabilities incurred in connection with the Contemplated Transactions, (iv) Liabilities for performance of obligations of Company or any Subsidiary under any Company Contract (other than for breach thereof), and (v) Liabilities disclosed in Part 3.5(e) of the Company Disclosure Schedule.
(f) Since January 1, 2017, there have been no formal investigations regarding financial reporting or accounting policies and practices discussed with, reviewed by or initiated at the direction of the chief executive officer, chief financial officer or general counsel of Company, the board of directors of Company or any committee thereof. Since January 1, 2017, neither Company nor its independent auditors have identified (i) any significant deficiency or material weakness in the system of internal accounting controls utilized by Company, (ii) any fraud, whether or not material, that involves Companys management or other employees who have a role in the preparation of financial statements or the internal accounting controls utilized by Company, or (iii) any claim or allegation regarding any of the foregoing.
(g) There are no Encumbrances on any cash or cash equivalents held by any Acquiring Company.
(h) Company is, and since January 1, 2017 has been, in material compliance with (i) the applicable listing and corporate governance rules and regulations of Nasdaq and (ii) the applicable provisions of the Sarbanes-Oxley Act. Company has delivered or made available to F-Star complete and correct copies of all material correspondence between Nasdaq and Company since January 1, 2017.
3.6 Absence of Certain Changes or Events. Except as set forth in Part 3.6 of the Company Disclosure Schedule or as disclosed in Companys SEC Documents, from the date of the Company Balance Sheet through the date hereof, each of the Acquiring Companies has conducted its business in all material respects in the ordinary course of business consistent with past practice and there has not been (a) any event that has had a Company Material Adverse Effect or (b) any action, event or occurrence that would have required the consent of F-Star pursuant to Section 5.1 had such action, event or occurrence taken place after the execution and delivery of this Agreement.
3.7 Taxes. Each of the representations and warranties set forth in this Section 3.7 is qualified by except as would not, individually or in the aggregate, have a Company Material Adverse Effect.
(a) Each income Tax Return and each other material Tax Return required to be filed by or with respect to any Acquiring Company has been timely filed (taking into account all valid extensions), and all such Tax Returns were true, complete and accurate in all respects. All Taxes due and payable by the Acquiring Companies (whether or not shown on any Tax Return) have been timely paid, except to the extent such amounts are being contested in good faith and are properly reserved for on the books or records of the Acquiring Companies to the extent any such reserve is required under GAAP.
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(b) No waiver or agreement by or with respect to an Acquiring Company is in force for the extension of time for the payment, collection or assessment of any Taxes, and no request has been made by an Acquiring Company in writing for any such extension or waiver.
(c) There are no liens for Taxes on any asset of an Acquiring Company other than liens for Taxes not yet due and payable or Taxes contested in good faith and reserved against in accordance with GAAP.
(d) No Acquiring Company is the subject of any currently ongoing Tax audit or other proceeding with respect to Taxes nor has any audit or other proceeding with respect to Taxes been proposed against any of them in writing, and any deficiencies asserted or assessments made as a result of any audit or other proceeding with respect to Taxes have been paid in full or adequate accruals or reserves for any such deficiencies or assessments have been established and are reflected on Part 3.7(d) of the Company Disclosure Schedule and in the Company Financials.
(e) All material Taxes that an Acquiring Company has been required to collect or withhold have been duly collected or withheld and, to the extent required by applicable Legal Requirements when due, have been duly and timely paid to the proper Governmental Body.
(f) No closing agreements, private letter rulings, technical advice memoranda or similar agreements or rulings have been entered into by any Acquiring Company with any taxing authority or issued by any taxing authority to an Acquiring Company. There are no outstanding rulings of, or request for rulings with, any Governmental Body addressed to an Acquiring Company that are, or if issued would be, binding on an Acquiring Company.
(g) No Acquiring Company is a party to any Contract with any Person (other than one or more Acquiring Companies) relating to allocating or sharing the payment of, or Liability for, Taxes or Tax benefits (other than pursuant to customary provisions included in agreements not primarily related to Taxes and entered into in the ordinary course of business). No Acquiring Company has any Liability for the Taxes of any Person (other than one or more Acquiring Companies) as a transferee or successor or otherwise by operation of Legal Requirements.
(h) Within the past two (2) years, no Acquiring Company has been a member of an affiliated group of corporations within the meaning of Section 1504 of the Code or of any group that has filed a combined, consolidated or unitary Tax Return under state, local or foreign Tax Legal Requirement (other than a group the common parent of which was Company).
(i) No Acquiring Company has participated in, or is currently participating in, a listed transaction within the meaning of Treasury Regulation Section 1.6011-4(b)(2).
(j) Within the past two (2) years, no Acquiring Company has distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by Sections 355 or 361 of the Code.
(a) Part 3.8(a)(i) of the Company Disclosure Schedule lists all of the Patent Rights, Trademark Rights (including domain name registrations) and registered Copyrights owned solely by or registered solely to any Acquiring Company as of the date hereof, setting forth in each case, as applicable, the jurisdictions in which patents have been issued, patent applications have been filed, trademarks have been registered and trademark applications have been filed, along with the respective application, registration or filing number thereof. Part 3.8(a)(ii) of the Company Disclosure Schedule lists, as of the date hereof, all of the Patent Rights, Trademark Rights (including domain name registrations) and registered Copyrights in which any Acquiring Company has any co-ownership interest, other than those owned solely by an Acquiring Company, setting forth in each case, as applicable, the jurisdictions in which patents have been issued, patent applications have been filed, trademarks have been registered, trademark applications have been filed and registered copyrights and copyright applications have been filed, along with the respective application, registration or filing number thereof. Part 3.8(a)(iii) of the Company Disclosure Schedule lists all of the third party Patent Rights, Trademark
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Rights (including domain name registrations) and registered Copyrights in which an Acquiring Company has any exclusive right, title or interest, other than those owned solely or co-owned by an Acquiring Company and identified in Part 3.8(a)(i) or 3.8(a)(ii) of the Company Disclosure Schedule.
(b) Part 3.8(b) of the Company Disclosure Schedule lists all Contracts in effect as of the date hereof under which any third party has licensed, granted or conveyed to any Acquiring Company any right, title or interest in or to any Company IP Rights, other than (i) shrink wrap or click through license agreements accompanying widely available computer software that has not been modified or customized for an Acquiring Company and where such software is not material to its business and (ii) when entered into in the ordinary course of business, material transfer agreements, clinical trial-related agreements (including Contracts with clinical research organizations), services agreements, non-disclosure agreements or other ordinary course Contracts with non-exclusive inbound licenses (including with research institutes). No Acquiring Company and, to Companys knowledge, no other party to any such Contract has breached or violated in any material respect or materially defaulted under, or received notice that it has breached, violated or defaulted under, any of the terms or conditions of any such Contract.
(c) Part 3.8(c) of the Company Disclosure Schedule lists all Contracts in effect as of the date hereof under which an Acquiring Company has licensed, granted or conveyed to any third party any right, title or interest in or to any Company IP Rights (collectively, Company Out Licenses); provided, that Company Out Licenses shall not include, when entered into in the ordinary course of business, material transfer agreements, clinical trial-related agreements (including Contracts with clinical research organizations), services agreements, non-disclosure agreements or other ordinary course Contracts with non-exclusive outbound licenses (including with research institutes). No Acquiring Company and, to Companys knowledge, no other party to any such contract has breached or violated in any material respect or materially defaulted under, or received notice that it has breached, violated or defaulted under, any of the terms or conditions of any such Contract.
(d) The Acquiring Companies own, co-own or otherwise possess legally enforceable rights in and to all Company Owned IP Rights, free and clear of all Encumbrances. The Company IP Rights that are owned by an Acquiring Company and listed in Part 3.8(a)(i) of the Company Disclosure Schedule or co-owned by an Acquiring Company and listed in Part 3.8(a)(ii) of the Company Disclosure Schedule (collectively, Company Registered IP Rights) are valid and subsisting and have not been found to be invalid or unenforceable by any Governmental Body. No third party is overtly challenging the right, title or interest of an Acquiring Company in, to or under the Company Registered IP Rights, or the validity, enforceability or claim construction of any Company Registered IP Rights, and there is no opposition, cancellation, proceeding, objection or claim pending with regard to any Company Registered IP Rights. The Company Registered IP Rights are not subject to any outstanding order, judgment, decree or agreement affecting the Acquiring Companies use thereof or their rights thereto. To the knowledge of Company, no valid basis exists for any of the foregoing challenges or claims. To the knowledge of Company, all necessary registration, maintenance and renewal fees in respect of the Company Registered IP Rights have been paid and all necessary documents and certificates have been filed with the relevant Governmental Body for the purpose of maintaining such Company Registered IP Rights.
(e) Each Acquiring Company has taken reasonable measures to protect and maintain the confidentiality of the Trade Secrets included in the Company Owned IP Rights. The Acquiring Companies have not divulged, furnished to or made accessible any of their Trade Secrets to any Person except (x) pursuant to an enforceable written agreement to maintain the confidentiality of such Trade Secrets, (y) to the United States Patent and Trademark Office (or any of its foreign equivalents) or (z) in connection with the filing of an application to obtain patent protection for the embodiment of such Trade Secret, and the Acquiring Companies otherwise take and have taken reasonable measures to maintain the confidentiality of their Trade Secrets. All current and former officers and employees of, and consultants and independent contractors, each Acquiring Company who has contributed to the creation or development of any material Company Owned IP Rights (i) have assigned all of their respective ownership rights in such IP Rights to such Acquiring Company pursuant to written agreements that have executed and delivered to such Acquiring Company (containing no exceptions or exclusions from the scope of the coverage contained in such Acquiring Companys applicable form agreement) regarding the
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assignment to such Acquiring Company (Company IP Assignment Agreements) and (ii) do not have any claim, right (whether or not currently exercisable) or interest to or in any Company Owned IP Rights. To the knowledge of Company, no current or former director, officer or employee of, or consultant or independent contractor to, any Acquiring Company has breached any material term of any IP Assignment Agreements. All IP Assignment Agreements have been made available to F-Star.
(f) To the knowledge of Company and except for any statutory exception to infringement, no current activity of any Acquiring Company violates or infringes (directly, contributorily, by inducement, or otherwise), misappropriates or violates any IP Rights of any third party or makes unlawful use of any IP Right of any other Person. No infringement, misappropriation, or similar claim is pending or, to the knowledge of Company, threatened against any Acquiring Company or against any other Person who is or may be entitled to be indemnified, defended, held harmless, or reimbursed by any Acquiring Company with respect to such claim. Since January 1, 2015, no Acquiring Company has received any written notice nor are any of them subject to any actual or, to the knowledge of Company, threatened proceedings, claiming or alleging any of the foregoing.
(g) To the knowledge of Company, no Company Owned IP Rights are being infringed, misappropriated or unlawfully used by any Person nor has any Person previously infringed, misappropriated or unlawfully used any such Company Owned IP Rights.
(h) The execution, delivery and performance of this Agreement by Company will not contravene, conflict with or result in the imposition of any additional limitation on the Acquiring Companies right, title or interest in or to any material Company Owned IP Rights.
(i) Other than Company Owned IP Rights related to Permitted Disposition Assets, no funding, facilities, or personnel of any Governmental Body or any public or private university, college or other educational or research institution were used by any Acquiring Company to develop or create, in whole or in part, any Company Owned IP Rights that would grant any mandatory or compulsory ownership rights. No Acquiring Company is now nor has any Acquiring Company ever been a member or promoter of, or a contributor to, any industry standards body or similar organization that could require or obligate the Acquiring Company to grant or offer to any other Person any license or right to any Company Owned IP Rights.
(j) To the knowledge of Company, no breach or violation of any electronic or other database containing (in whole or in part) Sensitive Company Data or any security policy of Company has occurred or is threatened, and there has been no unauthorized or illegal use of or access to information systems and/or the Sensitive Company Data. No Person (including any Governmental Body) has asserted a claim, or otherwise threatened in writing to commence any action, against any Acquiring Company alleging a violation of any privacy policy of the Acquiring Companies or the applicable Legal Requirements pertaining to privacy and data protection. No Acquiring Company has received any written inquiry or complaint from any Governmental Body regarding the collection, use, retention, storage, security, transfer, disposal, disclosure or other processing of Sensitive Company Data by or for the Acquiring Companies.
3.9 Compliance with Legal Requirements.
(a) Since January 1, 2017, no Acquiring Company has been or is in conflict with, or in default or violation of, (i) any Legal Requirement or Order applicable to an Acquiring Company or by which its or any of its properties is bound or affected or (ii) any Contract to which an Acquiring Company is a party or by which an Acquiring Company or its properties is bound or affected, except for any conflicts, defaults or violations which would not, individually or in the aggregate, have a Company Material Adverse Effect. Except as set forth in Part 3.9 of the Company Disclosure Schedule, no investigation or review by any Governmental Body is pending or, to the knowledge of Company, threatened against any Acquiring Company, nor has any Governmental Body indicated to an Acquiring Company in writing an intention to conduct the same.
(b) Except as would not, individually or in the aggregate, have a Company Material Adverse Effect, the Acquiring Companies hold all permits, licenses, authorizations, variances, exemptions, orders and approvals from applicable Governmental Bodies which are necessary to the operation of the business of the Acquiring
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Companies taken as a whole (collectively, the Company Permits). The Acquiring Companies are in compliance in all material respects with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the knowledge of Company, threatened, which seeks to revoke or limit any Company Permit. Company has made available to F-Star all material Company Permits.
(c) To the knowledge of Company, the Acquiring Companies and Persons acting in concert with and on behalf of Company:
(i) have not used in any capacity the services of any individual or Entity debarred, excluded, or disqualified under 21 U.S.C. Section 335a, 42 U.S.C. Section 1320a-7 or 21 C.F.R. Section 312.70, or any similar Legal Requirements in any jurisdiction; and
(ii) have not been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment, exclusion, or disqualification under 21 U.S.C. Section 335a, 42 U.S.C. Section 1320a-7 or 21 C.F.R. Section 312.70 or any similar Legal Requirements in any jurisdiction.
(d) None of the Acquiring Companies and, to the knowledge of Company, no Representative of any Acquiring Company or Person acting in concert with or on behalf of the Acquiring Companies, or any officers, employees or Representatives of the same, has with respect to any product that is manufactured, tested, distributed, held or marketed by or on behalf of any of the Acquiring Companies made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities policy that is set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Body to invoke any similar policy.
(e) None of the Acquiring Companies and, to the knowledge of Company, no Representative of any Acquiring Company or Person acting in concert with or on behalf of the Acquiring Companies, or any officers, employees or Representatives of the same with respect to any matter relating to any of the Acquiring Companies, has: (i) used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity; (ii) made any unlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns or violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, the U.K. Bribery Act of 2010 or any other analogous legislation in any jurisdiction, as amended; or (iii) made any other unlawful payment.
(f) At no time since January 1, 2018 has any of the Acquiring Companies received written notice that any Governmental Body or institutional review board has commenced, or threatened to initiate, any proceeding seeking the suspension or termination of preclinical or clinical research with respect to any product candidate being researched or developed by or on behalf of any of the Acquiring Companies, including any action regarding any investigator participating in any such clinical research. Company has, prior to the execution of this Agreement, provided or made available to F-Star all information about material adverse drug experiences since January 1, 2018 obtained or otherwise received by any of the Acquiring Companies from any source, in the United States or outside the United States, related to its respective current products or product candidates, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies or registries, reports in the scientific literature, and unpublished scientific papers relating to any product or product candidate manufactured, tested, distributed, held or marketed by any of the Acquiring Companies or any of their licensees in the possession of any of the Acquiring Companies (or to which any of them has access). Company has disclosed to F-Star all material information known by Company with respect to the safety and efficacy of Companys products and product candidates from nonclinical and/or clinical studies. Each of the Acquiring Companies has filed all annual and periodic reports, amendments and safety reports required to be made by an Acquiring Company for any Company product or service required to be made to the FDA or any other Governmental Body.
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(g) All preclinical and clinical studies relating to product or product candidates, conducted by or on behalf of the Acquiring Companies have been, or are being, conducted in all material respects in compliance with the applicable requirements of the FDAs Good Laboratory Practice and Good Clinical Practice requirements, including regulations codified at 21 C.F.R. Parts 50, 54, 56, 58, and 312, as amended from time to time, and all applicable similar requirements in other jurisdictions, including all requirements relating to protection of human subjects participating in any such clinical studies; provided, however, that the foregoing representation and warranty is made (i) only to Companys knowledge with respect to clinical and preclinical studies conducted by any third party on behalf of the Acquiring Companies and (ii) specifically excludes preclinical studies that were not designed to be conducted in accordance with Good Laboratory Practice. No Acquiring Company has received any notices or correspondence from the FDA or any other Governmental Body requiring the termination, suspension or material modification of any preclinical study or clinical trial after initiation thereof by or on behalf of an Acquiring Company.
(h) Each of the Acquiring Companies has filed with the FDA, any other Governmental Body, and any institutional review board, all material required notices, supplemental applications, and annual or other reports, including adverse experience reports, with respect to each investigational new drug application or any comparable foreign regulatory application, related to the manufacture, testing, study, or sale of any of its products or product candidates, as applicable.
(i) None of the Acquiring Companies is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Body. None of the Acquiring Companies is subject to any investigation that is pending or, to the knowledge of Company, that has been threatened, in each case by (i) the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.) or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Federal Civil False Claims Act (31 U.S.C. §3729), or any similar investigation that is pending or, to the knowledge of Company, that has been threatened by any other Governmental Body pursuant to any other applicable Legal Requirements. Each of the Acquiring Companies has complied in all material respects with all applicable security and privacy standards related to protected health information under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, as amended from time to time. No Acquiring Company has experienced any material security breach or other incident resulting in the unauthorized access to, use of, or disclosure of protected health information. Each Acquiring Company is, and has at all times since January 1, 2017 been, in compliance with all Legal Requirements and contractual obligations regarding the privacy, protection, storage, use and disclosure of Personal Data collected by such Acquiring Company, except as would not, individually or in the aggregate, have an F-Star Material Adverse Effect.
(j) None of the Acquiring Companies has received any FDA Form 483s, warning letters, untitled letters, cyber letters, notices of violation, consent decrees, notices of investigation, indictments, sentencing memoranda, plea agreements, court orders, target or no-target letters, proceedings, reviews (including data integrity reviews) or other notice of enforcement action from a Governmental Body.
3.10 Legal Proceedings; Orders.
(a) Except as set forth in Part 3.10(a)(i) of the Company Disclosure Schedule, during the three (3)-year period prior to the date hereof there has not been, and there is no pending, or threatened in writing, any Legal Proceeding and, to the knowledge of Company, no Person has threatened to commence any Legal Proceeding: (i) that involves any of the Acquiring Companies, any business of any of the Acquiring Companies or any of the assets owned, leased or used by any of the Acquiring Companies; or (ii) that challenges, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, any of the Contemplated Transactions. None of the Legal Proceedings identified in Part 3.10(a)(i) of the Company Disclosure Schedule has had or, if adversely determined, would have or result in, either individually or in the aggregate, a Company Material Adverse Effect. Except as set forth in Part 3.10(a)(ii) of the Company Disclosure Schedule, to the knowledge of Company, no event has occurred, and no claim, dispute or other condition or circumstance exists,
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that would reasonably be expected to give rise to or serve as a basis for the commencement of any Legal Proceeding of the type described in clause (i) or clause (ii) of the first sentence of this Section 3.10(a). With regard to any Legal Proceeding set forth on Part 3.10(a)(i) or (ii) of the Company Disclosure Schedule, Company has provided F-Star or its counsel all pleadings and material written correspondence related to such Legal Proceeding, all insurance policies and material written correspondence with brokers and insurers related to such Legal Proceedings and other information material to an assessment of such Legal Proceeding. Company has an insurance policy or policies that is expected to cover such Legal Proceeding and has complied with the requirements of such insurance policy or policies to obtain coverage with respect to such Legal Proceeding under such insurance policy or policies.
(b) There is no Order to which any of the Acquiring Companies, or any of the assets owned or used by any of the Acquiring Companies, is subject. To the knowledge of Company, no officer or other key employee of any of the Acquiring Companies is subject to any Order that prohibits such officer or other employee from engaging in or continuing any conduct, activity or practice relating to the business of any of the Acquiring Companies or to any material assets owned or used by any of the Acquiring Companies.
3.11 Brokers and Finders Fees. Except as set forth in Part 3.11 of the Company Disclosure Schedule, no broker, finder or investment banker is entitled to any brokerage, finders or other fee or commission in connection with the Contemplated Transactions based upon arrangements made by or on behalf of any of the Acquiring Companies. Company has furnished to F-Star accurate and complete copies of all agreements under which any such fees, commissions or other amounts have been paid or may become payable and all indemnification and other agreements related to the engagement of any Persons listed on Part 3.11 of the Company Disclosure Schedule.
(a) Part 3.12(a) of the Company Disclosure Schedule sets forth, as of the date hereof, a complete and accurate list of each material plan, program, policy, Contract or other arrangement providing for employment, compensation, retirement, pension, deferred compensation, severance, separation, relocation, termination pay, performance awards, bonus, incentive compensation, stock option, stock purchase, stock bonus, phantom stock, stock appreciation right, other equity-based award, supplemental retirement, profit sharing, material fringe benefits, cafeteria benefits, medical benefits, life insurance, disability benefits, accident benefits, salary continuation, accrued leave, vacation, or other material employee benefits, whether written or unwritten, and each other employee benefit plan within the meaning of Section 3(3) of ERISA, in each case, for current, retired or former employees, directors or consultants of Company or its Subsidiaries, which is sponsored, maintained, contributed to, or required to be contributed to by Company or its Subsidiaries or with respect to which the Company or its Subsidiaries has any material Liability (collectively, the Company Employee Plans).
(b) Company has made available to F-Star true and complete copies of each Company Employee Plan and all material related plan documents, including trust documents, plan amendments, Insurance Policies or contracts, summary plan descriptions, and compliance and nondiscrimination tests (including 401(k) and 401(m) tests) for the last three plan years. With respect to each Company Employee Plan that is subject to ERISA reporting requirements, Company has made available to F-Star copies of the Form 5500 reports filed by or on behalf of an Acquiring Company with respect to any Company Employee Plan for the most recent plan year. Each Company Employee Plan that is intended to be qualified under Section 401(a) of the Code has received a favorable determination letter from the Internal Revenue Service that remains effective or is entitled to rely on a favorable opinion letter from the Internal Revenue Services on the form of such Company Employee Plan, and to Companys knowledge, nothing has occurred since the issuance of each such letter that would reasonably be expected to cause the loss of the tax-qualified status of any Company Employee Plan subject to Section 401(a) of the Code. Company has made available to F-Star the most recent Internal Revenue Service determination or opinion letter issued with respect to each such Company Employee Plan, as applicable.
(c) Each Company Employee Plan has been maintained and administered in all material respects in accordance with its terms and in material compliance with the requirements prescribed by applicable Legal Requirements (including ERISA and the Code). None of the Company Employee Plans promises or provides
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retiree medical or other retiree welfare benefits to any person, except to the extent required by Section 4980B of the Code or any similar state or non-U.S. Legal Requirement. With respect to each Company Employee Plan, no reportable event within the meaning of Section 4043 of ERISA (excluding any such event for which the thirty (30) day notice requirement has been waived under the regulations to Section 4043 of ERISA) has occurred, nor has any event described in Section 4062, 4063 or 4041 or ERISA occurred, in each case, that could reasonably result in material Liability to Company or its Subsidiaries. No suit or material administrative proceeding or action is pending, or to the knowledge of Company, is threatened, against or with respect to any Company Employee Plan, including any audit by the Internal Revenue Service or the United States Department of Labor (other than routine claims for benefits arising under such plans).
(d) Neither Company nor any ERISA Affiliate of Company has ever maintained, established, sponsored, participated in or contributed to, or is or has been obligated to contribute to, or otherwise incurred any Liability under, any multiemployer plan (as defined in Section 3(37) of ERISA) or any pension plan (as defined in Section 3(2) of ERISA) subject to Title IV of ERISA or Section 412 of the Code.
(e) Other than as specifically contemplated by this Agreement or as set forth on Part 3.12(e) of the Company Disclosure Schedule, the consummation of the Acquisition will not, either alone or in combination with another event, (i) entitle any current or former employee or other service provider of any Acquiring Company to severance benefits or any other payment (including golden parachute or bonus payments); (ii) accelerate the time of payment or vesting of any such payments or benefits or increase the amount of compensation or benefits due any such employee or service provider; (iii) result in the forgiveness of any indebtedness; or (iv) result in any obligation to fund future benefits under any Company Employee Plan. No benefit payable or that may become payable by Company in connection with the Contemplated Transactions or as a result of or arising under this Agreement (either alone or in combination with another event) is reasonably likely to constitute an excess parachute payment (as defined in Section 280G(b)(1) of the Code) subject to the imposition of an excise Tax under Section 4999 of the Code or the deduction for which would be disallowed by reason of Section 280G of the Code.
(f) Company does not sponsor, contribute to or have any Liability with respect to any employee benefit plan, program or arrangement that provides benefits to nonresident aliens with no United States source income outside of the United States.
3.13 Title to Assets; Real Property. Except as set forth on Part 3.13 of the Company Disclosure Schedule, the Acquiring Companies own, and have good, valid and marketable title to, all material tangible assets purported to be owned by them, including all material tangible assets reflected in the books and records of the Acquiring Companies as being owned by the Acquiring Companies. All of said assets are owned by the Acquiring Companies free and clear of any Encumbrances, except for (i) any lien for current Taxes not yet due and payable or for Taxes that are being contested in good faith and for which adequate reserves have been made on the Company Financials, (ii) liens that have arisen in the ordinary course of business and that do not (individually or in the aggregate) materially detract from the value of the assets subject thereto or materially impair the operations of the Acquiring Companies, and (iii) Encumbrances described in Part 3.13 of the Company Disclosure Schedule. The Acquiring Companies do not own and have never owned any real property, and do not currently hold any interest in real property, except for the leaseholds created under the real property leases identified in Part 3.13 of the Company Disclosure Schedule. The Acquiring Companies are the lessees of, and hold valid leasehold interests in, all assets purported to have been leased by them, including all assets reflected in the books and records of the Acquiring Companies as being leased to the Acquiring Companies, and the Acquiring Companies enjoy undisturbed possession of such leased assets. Part 3.13 of the Company Disclosure Schedule sets forth a complete and accurate list of all real property leases to which any Acquiring Company is a party, which are each in full force and effect, and with no existing material default thereunder.
3.14 Environmental Matters. Each Acquiring Company is in compliance with all applicable Environmental Laws, which compliance includes the possession by Company of all permits and other authorizations required under applicable Environmental Laws and compliance with the terms and conditions thereof, except where the failure to be in compliance would not, individually or in the aggregate, have a
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Company Material Adverse Effect. Since January 1, 2017, no Acquiring Company has received any written notice or other communication (in writing or otherwise), whether from a Governmental Body, citizens group, employee or otherwise, that alleges that any Acquiring Company is not in material compliance with any Environmental Law, and, to the knowledge of Company, there are no circumstances existing as of the date hereof that would prevent or interfere with any Acquiring Companys material compliance with any Environmental Law in the future. To the knowledge of Company: (i) no current or prior owner of any property leased or controlled by any Acquiring Company has received any written notice or other communication relating to property owned or leased at any time by any Acquiring Company, whether from a Governmental Body, citizens group, employee or otherwise, that alleges that such current or prior owner or any Acquiring Company is not in compliance with or has violated any Environmental Law relating to such property and (ii) no Acquiring Company has any material liability under any Environmental Law.
(a) Part 3.15(a) of the Company Disclosure Schedule sets forth a true, complete and correct list of all employees of the Acquiring Companies along with each such employees position, whether classified as exempt or non-exempt for wage and hour purposes, business location, status (i.e., active or inactive and if inactive, the type of leave and estimated duration), hire date, 2019 actual compensation and annual rate of compensation for 2020 (including base salary and the target amount of any bonuses to which such employee may be eligible) and the total amount of bonus, retention, severance and other amounts to be paid to such employee at the Closing or otherwise in connection with the Acquisition.
(b) There are no agreements or other arrangements between the Acquiring Companies and any trade union or other body representing employees.
(c) The Acquiring Companies are in compliance in all material respects with all Legal Requirements relating to employment practices, terms and conditions of employment, and the employment of former, current, and prospective employees, individual independent contractors and leased employees (within the meaning of Section 414(n) of the Code in the United States and other Legal Requirements in any jurisdiction in which the Acquiring Companies employ interim employees), including all such Legal Requirements and Contracts relating to wages, hours, collective bargaining, classification of employees, employment discrimination, immigration, disability, civil rights, fair labor standards, occupational safety and health, and workers compensation, and have timely prepared and, as applicable, filed all employment-related forms (including United States Citizenship and Immigration Services Form I-9) to the extent required by any relevant Governmental Body.
(a) Part 3.16 of the Company Disclosure Schedule lists each of the following Contracts in effect as of the date of this Agreement to which any Acquiring Company is a party or by which any Acquiring Company is bound:
(i) any Contract with any distributor, reseller or sales representative;
(ii) any Contract with any manufacturer, vendor or other Person for the supply of materials or performance of services by such third party to Company in relation to clinical trials or the manufacture of Companys products or product candidates that (a) contemplates or involves the payment or delivery of cash or other consideration in an amount or has a value in excess of $50,000 in the aggregate, or contemplates or involves the performance of services having a value in excess of $50,000 in the aggregate or (b) is material to the business or operations of the Acquiring Companies, taken as a whole;
(iii) any Contract incorporating or relating to any guaranty, any warranty, any sharing of Liabilities or any indemnity not entered into in the ordinary course of business, including any indemnification agreements between an Acquiring Company and any of its officers or directors;
(iv) any Contract imposing any material restriction on the right or ability of any Acquiring Company: (A) to compete with any other Person; (B) to acquire any product or other asset or any services from any other Person; (C) to develop, sell, supply, distribute, offer, support or service any product or any technology or other asset to or for any other Person; (D) to perform services for any other Person; or (E) to otherwise transact business with any other Person;
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(v) any Contract relating to the disposition or acquisition of any material interest in, or any material amount of, property or assets of any Acquiring Company, other than in the ordinary course of business, or any ownership interest in any corporation, partnership, joint venture or other business enterprise;
(vi) any Contract relating to the borrowing of money or extension of credit;
(vii) any joint marketing, research, development or collaboration Contract;
(viii) any Contract that gives rise to any material payment or benefit as a result of the performance of this Agreement;
(ix) any Contract that provides for: (A) any right of first refusal, right of first negotiation, right of first notification or similar right with respect to any securities or assets of any Acquiring Company; or (B) any no shop provision or similar exclusivity provision with respect to any securities or assets of any Acquiring Company;
(x) any Contract providing any severance or change-in-control payment or benefit to any officer, director or employee of any Acquiring Company;
(xi) any Contract with any Governmental Body that is material to the business or operations of any Acquiring Company;
(xii) any interested party Contracts;
(xiii) any Contract containing any royalty, dividend or similar arrangement based on the revenues or profits of any Acquiring Company;
(xiv) any Contract for leased real property;
(xv) any Contract with any financial advisor, broker, finder, investment bank or other Person, providing advisory services; or
(xvi) any Contract that contemplates or involves the payment or delivery of cash or other consideration in an amount or has a value in excess of $100,000 in the aggregate, or contemplates or involves the performance of services having a value in excess of $100,000 in the aggregate, other than any arrangement or agreement expressly contemplated by or provided for in this Agreement, that does not allow an Acquiring Company to terminate the Contract for convenience with no more than ninety (90) days prior notice to the other party and without the payment of any rebate, chargeback, penalty or other amount to such third party in connection with any such termination.
(b) Company has made available to F-Star an accurate and complete copy of each Contract listed or required to be listed in Part 3.16 of the Company Disclosure Schedule (any such Contract, a Company Contract). There are no Company Contracts that are not in written form. No Acquiring Company and, to Companys knowledge, no other party to a Company Contract has breached or violated in any material respect or materially defaulted under, or received notice that it has breached, violated or defaulted under, any of the terms or conditions of any of the Company Contracts. To the knowledge of Company, no event has occurred, and no circumstance or condition exists, that (with or without notice or lapse of time or both) would reasonably be expected to: (i) result in a violation or breach in any material respect of any of the provisions of any Company Contract; (ii) give any Person the right to declare a default in any material respect under any Company Contract; (iii) give any Person the right to receive or require a rebate, chargeback, penalty or change in delivery schedule under any Company Contract; (iv) give any Person the right to accelerate the maturity or performance of any Company Contract; or (v) give any Person the right to cancel, terminate or modify any Company Contract. Except as set forth on Part 3.16 of the Company Disclosure Schedule, the consummation of the Acquisition will not (either alone or upon the occurrence of additional acts or events) result in any material payment or payments becoming due from any Acquiring Company to any Person under any Company Contract or give any Person the right to terminate or alter the provisions of any Company Contract. No Person is renegotiating any material amount paid or payable to any Acquiring Company under any Company Contract or any other material term or provision of any Company Contract. Each Company Contract is valid, binding, enforceable and in full force and effect, except as enforceability may be limited by bankruptcy and other similar laws and general principles of equity.
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3.17 Books and Records. The minute books of the Acquiring Companies have been made available to F-Star and Sellers or their respective counsel and contain accurate summaries, in all material respects, of all meetings of directors (or committees thereof) and stockholders or actions by written consent since January 1, 2018. Each of the stock certificate books, registers of stockholders and other corporate registers of the Acquiring Companies comply in all material respects with the provisions of all applicable Legal Requirements and are complete and accurate in all material respects.
(a) Part 3.18(a) of the Company Disclosure Schedule sets forth each Insurance Policy to which any Acquiring Company is a party. Each Insurance Policy is in full force and effect, maintained with reputable companies against loss relating to the business, operations and properties and such other risks as companies engaged in similar business as the Acquiring Companies would, in accordance with good business practice, customarily insure. All premiums due and payable under such Insurance Policies have been paid on a timely basis and each Acquiring Company is in compliance in all material respects with all other terms thereof. True, complete and correct copies of such Insurance Policies have been made available to F-Star.
(b) Except as set forth on Part 3.18(b) of the Company Disclosure Schedule, there are no material claims pending, under any Insurance Policy to which any Acquiring Company is a party, as to which coverage has been denied or disputed. All material claims thereunder have been noticed in time and since January 1, 2017 no Acquiring Company has been refused insurance for which it has applied or had any policy of insurance terminated (other than at its request), nor has any Acquiring Company received notice from any insurance carrier that: (i) such insurance will be canceled or that coverage thereunder will be reduced or eliminated; or (ii) premium costs with respect to such insurance will be increased, other than premium increases in the ordinary course of business applicable on their terms to all holders of similar policies.
3.19 Code of Ethics. Company has adopted a code of ethics, as defined by Item 406(b) of Regulation S-K of the SEC, for senior financial officers, applicable to its principal executive officer, principal financial officer, controller or principal accounting officer, or persons performing similar functions. Company has promptly disclosed any change in or waiver of Companys code of ethics with respect to any such persons, as required by Section 406(b) of the Sarbanes-Oxley Act. To the knowledge of Company, there have been no violations of provisions of Companys code of ethics by any such persons.
3.20 Opinion of Financial Advisor. The board of directors of Company has received an opinion of Ladenburg Thalmann & Co. Inc., financial advisor to Company, dated July 26, 2020, to the effect that the Acquisition Consideration is fair to the Company Stockholders from a financial point of view. Company will furnish an accurate and complete copy of said opinion to F-Star and Sellers for informational purposes only promptly after the date hereof.
3.21 Shell Company Status. Company is not an issuer identified in Rule 144(i)(1) of the Securities Act.
3.22 Government Contracts. Company has not been suspended or debarred from bidding on contracts with any Governmental Body, and to the knowledge of the Company, no such suspension or debarment has been initiated or threatened. The consummation of the Contemplated Transactions will not result in any such suspension or debarment of Company (assuming that no such suspension or debarment will result solely from the identity of F-Star).
3.23 Interested Party Transactions. Except as set forth on Part 3.23 of the Company Disclosure Schedule or disclosed in the Companys SEC Documents, no event has occurred since January 1, 2018 that would be required to be reported by any Acquiring Company as a Certain Relationship or Related Transaction pursuant to Item 404 of Regulation S-K pursuant to the Exchange Act.
(a) Part 3.24 of the Company Disclosure Schedule provides accurate information with respect to each account maintained by or for the benefit of Company at any bank or other financial institution, including the name of the bank or financial institution, the account number, the balance as of June 30, 2020 and the names of all individuals authorized to draw on or make withdrawals from such accounts.
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(b) All existing accounts receivable of Company (including those accounts receivable reflected on the Company Balance Sheet that have not yet been collected and those accounts receivable that have arisen since the date of the Company Balance Sheet and have not yet been collected) (i) represent valid obligations of customers of Company arising from bona fide transactions entered into in the ordinary course of business, and (ii) are current and collectible in full when due, without any counterclaim or set off, net of applicable reserves for bad debts on the Company Balance Sheet. All deposits of Company (including those set forth on the Company Balance Sheet) which are individually more than $10,000 or more than $25,000 in the aggregate are fully refundable to Company.
3.25 Disclosure; Company Information. None of the information supplied or to be supplied by or on behalf of Company for inclusion or incorporation by reference in the Registration Statement will, at the time the Registration Statement is filed with the SEC, at any time it is amended or supplemented, or at the time it becomes effective under the Securities Act, contain any statement that, in light of the circumstances under which it was made, is false or misleading with respect to any material fact or omit to state any material fact necessary in order to correct any statement of a material fact in any earlier communication with respect to the solicitation of proxies for the Company Stockholders Meeting which has become false or misleading. None of the information supplied or to be supplied by or on behalf of Company for inclusion or incorporation by reference in the Proxy Statement will, at the time the Proxy Statement is first mailed to the Company Stockholders or at the time of the Company Stockholders Meeting, contain any statement that, in light of the circumstances under which it was made, is false or misleading with respect to any material fact or omit to state any material fact necessary in order to correct any statement of a material fact in any earlier communication with respect to the solicitation of proxies for the Company Stockholders Meeting which has become false or misleading. The Registration Statement will comply as to form in all material respects with the applicable Legal Requirements. Notwithstanding the foregoing, no representation is made by Company with respect to the information that has been or will be supplied by any of the F-Star Companies, any Seller or any of their respective Representatives for inclusion in the Proxy Statement.
3.26 Exclusivity of Representations; Reliance.
(a) Except as expressly set forth in this Article 3, neither Company nor any Person on behalf of Company has made, nor are any of them making, any representation or warranty, written or oral, express or implied, at law or in equity, including with respect to merchantability or fitness for any particular purpose, in respect of Company or its business in connection with the Contemplated Transactions, including any representations or warranties about the accuracy or completeness of any information or documents previously provided (including with respect to any financial or other projections therein), and any other such representations and warranties are hereby expressly disclaimed.
(b)Company acknowledges and agrees that, except for the representations and warranties of F-Star set forth in Article 2 and Sellers set forth in Article 4, neither Company nor its Representatives is relying on any other representation or warranty of F-Star, Sellers, or any other Person made outside of Article 2 and Article 4, including regarding the accuracy or completeness of any such other representations or warranties or the omission of any material information, whether express or implied, in each case with respect to the Acquisition.
REPRESENTATIONS AND WARRANTIES OF SELLERS
Each Seller, severally and not jointly, represents and warrants to F-Star and Company as to itself as follows:
4.1 Ownership of F-Star Share Capital and Loan Notes. Such Seller is the sole record, legal and beneficial owner of, as of the date hereof, all of the shares of F-Star Issued Share Capital and all of the 2019 Loan Notes listed next to the name of such Seller on Part 4.1 of the F-Star Disclosure Schedule. As of the Closing, such Seller will be the sole record, legal and beneficial owner of all of the F-Star Shares listed next to the name of such Seller on Part 4.1 of the F-Star Disclosure Schedule as updated pursuant to Section 6.19 and delivered to Company prior to the Closing. Such Seller is not a party to any option, warrant, purchase right or other Contract that could require such Seller to sell, transfer or otherwise dispose of any of its shares of F-Star Share Capital (other than as set forth in this Agreement) and has good and valid title to all of the shares of F-Star
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Share Capital held by such Seller and will, as of the Closing, have good and valid title to all F-Star Shares issuable in respect of such shares of F-Star Share Capital, in each case free and clear of all Encumbrances. Subject only to stamping, upon the consummation of the Acquisition, Company will acquire good and marketable title to the F-Star Shares acquired by Company from such Seller, free and clear of all Encumbrances.
4.2 Authority; Non-Contravention.
(a) If a natural person, such Seller has the requisite legal capacity to enter into this Agreement, to perform its obligations hereunder and to consummate the Contemplated Transactions. If not a natural person, (i) such Seller has the requisite corporate, limited liability company or similar power and authority to enter into this Agreement, to perform its obligations hereunder and to consummate the Contemplated Transactions and (ii) the execution and delivery of this Agreement by such Seller, the performance by such Seller of its obligations hereunder and the consummation by such Seller of the Contemplated Transactions have been duly authorized by all necessary corporate action on the part of such Seller. This Agreement has been duly executed and delivered by such Seller and, assuming the due authorization, execution and delivery by F-Star and Company, constitutes the valid and binding obligation of such Seller, enforceable in accordance with its terms, subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other laws affecting creditors rights generally and general principles of equity.
(b) The execution and delivery of this Agreement by such Seller does not, and the performance of this Agreement by such Seller will not, conflict with or violate any Organizational Document or Legal Requirement applicable to such Seller or by which its properties are bound or affected.
(c) Such Seller is not subject to any Insolvency Proceedings.
(d) If such Seller is an Investor or becomes an Additional Investor in the F-Star Pre-Closing Financing, such Seller will at the time of the F-Star Pre-Closing Financing have such immediately available funds as are necessary to pay all amounts due from Seller to consummate the F-Star Pre-Closing Financing.
4.3 Tax Matters. Such Seller has had the opportunity to review with such Sellers tax advisors the applicable Tax consequences of the Contemplated Transactions, including the purchase of the F-Star Shares acquired from such Seller by Company. Such Seller is relying solely on such advisors and not on any statements or representations of Company or F-Star or any of their respective Representatives with respect to Tax matters. Such Seller understands that it (and not Company or F-Star) shall be responsible for such Sellers Tax Liability and any related interest and penalties that may arise as a result of the Contemplated Transactions.
4.4 Disclosure; Seller Information. None of the information supplied or to be supplied by or on behalf of such Seller for inclusion or incorporation by reference in the Registration Statement will, at the time the Registration Statement is filed with the SEC, at any time it is amended or supplemented, or at the time it becomes effective under the Securities Act, contain any statement that, in light of the circumstances under which it was made, is false or misleading with respect to any material fact or omit to state any material fact necessary in order to correct any statement of a material fact in any earlier communication with respect to the solicitation of proxies for the Company Stockholders Meeting which has become false or misleading. None of the information supplied or to be supplied by or on behalf of such Seller for inclusion or incorporation by reference in the Proxy Statement will, at the time the Proxy Statement is first mailed to the Company Stockholders or at the time of the Company Stockholders Meeting, contain any statement that, in light of the circumstances under which it was made, is false or misleading with respect to any material fact or omit to state any material fact necessary in order to correct any statement of a material fact in any earlier communication with respect to the solicitation of proxies for the Company Stockholders Meeting which has become false or misleading. Notwithstanding the foregoing, no representation is made by such Seller with respect to the information that has been or will be supplied by any other Seller, any of the Acquiring Companies, any of the F-Star Companies or any of their respective Representatives for inclusion in the Registration Statement or the Proxy Statement.
4.5 Ownership of Company Capital Stock; Affiliates. Such Seller (including such Sellers Affiliates) does not own, directly or indirectly, beneficially or of record, any shares of Company Common Stock or any other economic interest (through derivative securities or otherwise) in, Company. Other than as contemplated by this
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Agreement, no Seller is, nor at any time during the last three (3) years has been, an interested stockholder of Company within the meaning of Section 203 of Delaware Law. Except as set forth on Part 4.5 of the F-Star Disclosure Schedule, no Seller is an affiliate of any other Seller as such term is defined in Rule 12b-2 of the Exchange Act.
4.6 Exclusivity of Representations; Reliance.
(a) Except as expressly set forth in this Article 4, neither Sellers nor any Person on behalf of Sellers has made, nor are any of them making, any representation or warranty, written or oral, express or implied, at law or in equity, including with respect to merchantability or fitness for any particular purpose, in respect of Company or any of its Subsidiaries or Sellers in connection with the Contemplated Transactions, including any representations or warranties about the accuracy or completeness of any information or documents previously provided (including with respect to any financial or other projections therein), and any other such representations and warranties are hereby expressly disclaimed.
(b) Each Seller acknowledges and agrees that, except for the representations and warranties of Company set forth in Article 3, none of such Seller or any of such Sellers Representatives are relying on any other representation or warranty of Company or any other Person made outside of Article 3, including regarding the accuracy or completeness of any such other representations or warranties or the omission of any material information, whether express or implied, in each case with respect to the Contemplated Transactions.
CONDUCT OF BUSINESS PENDING THE CLOSING
5.1 Conduct of Company Business. Except (i) as set forth on Part 5.1 of the Company Disclosure Schedule, (ii) for the Approved Development Transaction and any Permitted Disposition, (iii) as expressly contemplated by this Agreement, (iv) as required by applicable Legal Requirements or (v) unless F-Star shall otherwise consent in writing (such consent not to be unreasonably withheld, delayed or conditioned), during the period from the date hereof and continuing until the earlier of the termination of this Agreement pursuant to its terms or the Closing (the Pre-Closing Period), Company shall, and shall cause its Subsidiaries to, conduct their respective businesses and operations (a) in the ordinary course of business consistent with past practice; provided that, Company may, in response to the coronavirus (COVID-19) pandemic, take such actions as Company deems reasonably necessary or advisable (A) to protect the health and safety of Companys or its Subsidiaries employees and other individuals having business dealings with Company or its Subsidiaries, (B) to respond to orders or guidance from any Governmental Body imposed in response to, or third-party supply or service disruptions caused by, such pandemic, or (C) to comply with any requirements imposed by third parties with whom the Company or its Subsidiaries does business; provided, further, that following the end of the pandemic or the termination of any orders or guidance of any Governmental Body relating thereto or any such third-party requirements, to the extent that Company or any of its Subsidiaries took any actions or refrained from taking any actions pursuant to the immediately preceding proviso that caused deviations from their respective businesses being conducted in the ordinary course of business consistent with past practice, Company shall, and shall cause its Subsidiaries to resume conducting their respective businesses in the ordinary course of business consistent with past practice as soon as reasonably practicable; and (b) in compliance in all material respects with all applicable Legal Requirements and requirements of all Contracts that constitute Company Contracts. In addition, without limiting the foregoing, other than as expressly contemplated by this Agreement (including the actions set forth on Part 5.1 of the Company Disclosure Schedule and the proviso set forth in the first sentence of this Section 5.1), or with the prior written consent of F-Star (which consent shall not be unreasonably withheld, delayed or conditioned), Company will not, and will not permit its Subsidiaries to:
(a) amend or otherwise change any of the Organizational Documents of any Acquiring Company or effect or be a party to any merger, consolidation, share exchange business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction except, for the avoidance of doubt, the Contemplated Transactions and any Permitted Disposition;
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(b) issue, sell, pledge, dispose of or encumber, or authorize the issuance, sale, pledge, disposition or encumbrance of, any shares of capital stock of any class, or any options, warrants, convertible securities or other rights of any kind to acquire any shares of capital stock, or any other ownership interest (including any phantom interest) (except for the issuance of shares of Company Common Stock issuable pursuant to Company Options or Company RSUs in accordance with the terms under the Company Option Plan or pursuant to Company Warrants, as the case may be, which Company Options, Company RSUs or Company Warrants, as the case may be, are outstanding on the date hereof);
(c) redeem, repurchase or otherwise acquire, directly or indirectly, any shares of Company Common Stock (other than pursuant to a Contract in effect on the date of this Agreement and which has been made available to F-Star prior to the date hereof);
(d) extend credit for borrowed money to any Person or incur any indebtedness for borrowed money or guarantee any indebtedness for borrowed money or issue or sell any debt securities or guarantee any debt securities or other obligations of any other Person or sell, pledge, dispose of or create an Encumbrance with respect to any assets (except for Encumbrances created by operation of law, pursuant to the terms of the Approved Development Transaction or any Permitted Disposition or dispositions of obsolete or worthless assets);
(e) accelerate, amend or change the period (or permit any acceleration, amendment or change) of exercisability of any Company Options or Company Warrants or authorize cash payments in exchange for any Company Options or Company Warrants, except as may be required under any Company Option Plan, Contract or this Agreement or as may be required by applicable Legal Requirements;
(f) (i) declare, set aside, make or pay any dividend or other distribution (whether in cash, stock or property or any combination thereof) in respect of any of its capital stock (other than the issuance of the CVRs in accordance with this Agreement and the CVR Agreements or the Permitted Dividend, if any), except that a wholly owned Subsidiary may declare and pay a dividend to its parent, (ii) split, combine or reclassify any of its capital stock or issue or authorize or propose the issuance of any other securities in respect of, in lieu of or in substitution for shares of its capital stock (other than the Company Reverse Stock Split) or (iii) amend the terms of, repurchase, redeem or otherwise acquire, or permit any Subsidiary to repurchase, redeem or otherwise acquire, any of its securities or any securities of its Subsidiaries, or propose to do any of the foregoing;
(g) sell, assign, transfer, license, sublicense or otherwise dispose of any IP Rights, other than (i) the Approved Development Transaction, (ii) a Permitted Disposition or (iii) in the ordinary course of business (which shall include material transfer agreements, clinical trial-related agreements (including Contracts with clinical research organizations), services agreements, non-disclosure agreements and other ordinary course Contracts with non-exclusive licenses (including with research institutes));
(h) materially change any royalty payment charged by Company or any of its Subsidiaries or materially change any royalty payment charged by Persons who have licensed IP Rights to Company or any of its Subsidiaries, except pursuant to the terms of the Approved Development Transaction or any Permitted Disposition;
(i) form any Subsidiary except for the purpose of effecting the Approved Development Transaction or a Permitted Disposition;
(j) acquire (by merger, consolidation, or acquisition of stock or assets) any corporation, partnership or other business organization or division thereof or any other material property or assets or any equity interest or other interest in any other Entity or enter into a joint venture with any other Entity;
(k) forgive any loans to any Person, including its employees, officers, directors or Affiliates;
(l) except as may be required under any Company Option Plan, Company Contract or this Agreement or as may be required by applicable Legal Requirements, (i) increase the compensation payable or to become payable to its directors, officers, employees or consultants, (ii) grant any severance, change in control, retention or termination pay to, or enter into any employment, severance or similar agreement with, any director, officer,
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employee or consultant, (iii) hire any new employee or consultant whose annual base salary is more than $150,000 per year, (iv) establish, adopt, enter into, terminate or amend in any material respect any collective bargaining or similar agreement or Company Employee Plan (or any plan, program, agreement or arrangement that would be a Company Employee Plan if it were in existence on the date hereof), or take any action to accelerate the time of payment or vesting of any compensation or benefits or take any action to fund or secure the funding of any compensation or benefits (other than qualified retirement plan benefits);
(m) take any action, other than as required by applicable Legal Requirements or GAAP, to change accounting policies or procedures;
(n) (i) make or change any material Tax election inconsistent with past practices, (ii) change any material Tax accounting method, or (iii) settle or compromise any material federal, state, local or foreign Tax Liability, except, in the case of clauses (i) and (ii), as required by Legal Requirements;
(o) pay, discharge or satisfy any claims or Liabilities (absolute, accrued, asserted or unasserted, contingent or otherwise), other than the payment, discharge or satisfaction in the ordinary course of business and consistent with past practice of Liabilities reflected or reserved against in the Company Financials, or incurred in the ordinary course of business and consistent with past practice;
(p) enter into any partnership arrangements, joint development agreements or strategic alliances except in connection with the Approved Development Transaction or any Permitted Disposition;
(q) except in connection with the Approved Development Transaction or any Permitted Disposition, enter into any Contract (i) involving annual payments by Company or any of its Subsidiaries greater than $25,000 in the aggregate, (ii) involving indemnification by Company or any of its Subsidiaries, other than in the ordinary course of business, (iii) relating to IP Rights (other than confidentiality agreements, assignment of inventions agreements between any Acquiring Company and any employee thereof and non-exclusive licenses in the ordinary course of business), and/or (iv) that is not terminable for convenience without penalty;
(r) amend in any material respect or terminate (except as provided in Section 6.26) any Company Contract;
(s) except in connection with the Approved Development Transaction, make any capital expenditure or capital commitment in excess of $25,000, other than capital expenditures or capital commitments in connection with Companys ongoing Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation, and cohort expansion study examining SB 11285 administered as an IV infusion in patients with advanced solid tumors (the STING Trial), not to exceed $50,000 in the aggregate;
(t) initiate any litigation, action, suit, proceeding, claim or arbitration (each, an Action), other than Actions against the vendors set forth on Schedule 5.1(t) for repayment of amounts in dispute, or settle or agree to settle any Action, other than any settlement which (i) provides a complete release of all claims against Company, and (ii) that does not involve the payment of any amount by Company in excess of $100,000 (after giving effect to any insurance coverage applicable to such settlement) (except for any Action arising out of or related to this Agreement or the Contemplated Transactions);
(u) fail to make any material payment with respect to any of Companys or any of its Subsidiaries accounts payable or indebtedness in a timely manner in accordance with the terms thereof and consistent with past practices;
(v) enter into or amend a Contract that would reasonably be expected to prevent or materially impede, interfere with, hinder or delay the consummation of the Contemplated Transactions; or
(w) take, or agree in writing or otherwise to take, any of the actions described in Sections 5.1(a) through 5.1(v) above.
The Parties acknowledge and agree that (i) nothing contained in this Agreement shall give F-Star, directly or indirectly, the right to control or direct the operations of any Acquiring Company prior to the Closing, (ii) prior to the Closing, each Acquiring Company shall exercise, consistent with the terms and conditions of this
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Agreement, complete control over its operations and (iii) notwithstanding anything to the contrary set forth in this Agreement, no consent of F-Star will be required with respect to any matter set forth in this Agreement to the extent the requirement of such consent would violate any applicable Legal Requirements.
5.2 Conduct of F-Star Business. Except as set forth on Part 5.2 of the F-Star Disclosure Schedule, as expressly contemplated by this Agreement, as required by applicable Legal Requirements or unless Company shall otherwise consent in writing (such consent not to be unreasonably withheld, delayed or conditioned), during the Pre-Closing Period, F-Star shall, and shall cause its Subsidiaries to, conduct their respective businesses and operations (a) in the ordinary course of business consistent with past practice; provided that F-Star may, in response to the coronavirus (COVID-19) pandemic, take such actions as F-Star deems reasonably necessary or advisable (A) to protect the health and safety of the employees of the F-Star Companies and other individuals having business dealings with any F-Star Companies, (B) to respond to orders or guidance from any Governmental Body imposed in response to, or third-party supply or service disruptions caused by, such pandemic, or (C) to comply with any requirements imposed by third parties with whom the F-Star Companies do business; provided, further, that following the end of the pandemic or the termination of any orders or guidance of any Governmental Body relating thereto or any such third-party requirements, to the extent that any F-Star Company took any actions or refrained from taking any actions pursuant to the immediately preceding proviso that caused deviations from its business being conducted in the ordinary course of business consistent with past practice, to resume conducting its business in the ordinary course of business consistent with past practice as soon as reasonably practicable; and (b) in compliance in all material respects with all applicable Legal Requirements and the requirements of all Contracts that constitute F-Star Contracts. In addition, without limiting the foregoing, other than as expressly contemplated by this Agreement (including the actions set forth on Part 5.2 of the F-Star Disclosure Schedule and the proviso set forth in the first sentence of this Section 5.2), or with the prior written consent of Company (which consent shall not be unreasonably withheld, delayed or conditioned), F-Star will not, and will not permit its Subsidiaries to:
(a) amend or otherwise change any of the Organizational Documents of any F-Star Company (other than in connection with the Conversions and the F-Star Pre-Closing Financing) or effect or be a party to any merger, consolidation, share exchange business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction except, for the avoidance of doubt, the Contemplated Transactions;
(b) issue, sell, pledge, dispose of or encumber, or authorize the issuance, sale, pledge, disposition or encumbrance of, any shares of capital stock of any class, or any options, warrants, convertible securities or other rights of any kind to acquire any shares of capital stock, or any other ownership interest (including any phantom interest) (except for the issuance of (i) F-Star Ordinary Shares pursuant to F-Star Options or F-Star RSUs granted prior to the date hereof in accordance with the terms of the F-Star Equity Plans, (ii) F-Star Ordinary Shares in the F-Star Pre-Closing Financing, (iii) up to $3,000,000 in aggregate principal amount of 2019 Loan Notes (including pursuant to any Equity Commitment Exchanges), and (iv) F-Star Ordinary Shares in the Conversions);
(c) except for the Conversions, redeem, repurchase or otherwise acquire, directly or indirectly, any shares in the F-Star Share Capital;
(d) extend credit for borrowed money to any Person or incur any indebtedness for borrowed money or guarantee any indebtedness for borrowed money or issue or sell any debt securities or guarantee any debt securities or other obligations of others or sell, pledge, dispose of or create an Encumbrance with respect to any assets (except for (i) sales of assets in the ordinary course of business and in a manner consistent with past practice, (ii) Encumbrances created by operation of law or dispositions of obsolete or worthless assets, (iii) the issuance of up to $3,000,000 in aggregate principal amount of 2019 Loan Notes (including pursuant to any Equity Commitment Exchanges));
(e) accelerate, amend or change the period (or permit any acceleration, amendment or change) of exercisability of options or authorize cash payments in exchange for any options, except as provided in Section 6.15 hereof;
(f) (i) declare, set aside, make or pay any dividend or other distribution (whether in cash, stock or property or any combination thereof) in respect of any shares in the F-Star Share Capital, except that a wholly
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owned Subsidiary may declare and pay a dividend to its parent, (ii) split, combine or reclassify any shares in the F-Star Share Capital or, except for the Conversions and except as specifically provided in Section 6.15 with respect to F-Star Options and F-Star RSUs, issue or authorize or propose the issuance of any other securities in respect of, in lieu of or in substitution for shares in the F-Star Share Capital or (iii) amend the terms of, repurchase, redeem or otherwise acquire, or permit any Subsidiary to repurchase, redeem or otherwise acquire, any of its securities or any securities of its Subsidiaries, or propose to do any of the foregoing;
(g) sell, assign, transfer, license, sublicense or otherwise dispose of any F-Star IP Rights, other than in the ordinary course of business (which shall include material transfer agreements, clinical trial-related agreements (including Contracts with clinical research organizations), services agreements, non-disclosure agreements and other ordinary course Contracts with non-exclusive licenses (including with research institutes));
(h) materially change any royalty payments charged by any F-Star Company or materially change any royalty payments charged by Persons who have licensed IP Rights to any F-Star Company other than in the ordinary course of business;
(i) form any Subsidiary;
(j) acquire (by merger, consolidation, or acquisition of stock or assets) any corporation, partnership or other business organization or division thereof or any other material property or assets or any equity interest or other interest in any other Entity or enter into a joint venture with any other Entity;
(k) forgive any loans to any Person, including its employees, officers, directors or Affiliates;
(l) take any action, other than as required by applicable Legal Requirements, IFRS or GAAP, to change accounting policies or procedures;
(m) (i) make or change any material Tax election inconsistent with past practices, (ii) change any material Tax accounting method, or (iii) settle or compromise any material federal, state, local or foreign Tax Liability, except, in the case of clauses (i) and (ii), as required by Legal Requirements;
(n) pay, discharge or satisfy any claims or Liabilities (absolute, accrued, asserted or unasserted, contingent or otherwise), other than the payment, discharge or satisfaction of Liabilities incurred in the ordinary course of business and consistent with past practice or otherwise incurred in connection with the Contemplated Transactions;
(o) other than in the ordinary course of business, enter into, materially amend or terminate any F-Star Contract (excluding, for the avoidance of doubt, any Equity Commitment Exchanges);
(p) enter into or amend a Contract that would reasonably be expected to prevent or materially impede, interfere with, hinder or delay the consummation of the Contemplated Transactions;
(q) settle or agree to settle any Action, other than in the ordinary course of business (except, subject to Section 6.25, for any Action arising out of or related to this Agreement or the Contemplated Transactions);
(r) amend, modify or waive any provision of any F-Star Pre-Closing Financing Agreement which would be materially adverse to Company (excluding, for the avoidance of doubt, any Equity Commitment Exchanges);
(s) take, or agree in writing or otherwise to take, any of the actions described in Sections 5.2(a) through (r) above.
The Parties acknowledge and agree that (i) nothing contained in this Agreement shall give Company, directly or indirectly, the right to control or direct the operations of any F-Star Company prior to the Closing, (ii) prior to the Closing, each F-Star Company shall exercise, consistent with the terms and conditions of this Agreement, complete control over its operations and (iii) notwithstanding anything to the contrary set forth in this Agreement, no consent of Company will be required with respect to any matter set forth in this Agreement to the extent the requirement of such consent would violate any applicable Legal Requirements. The parties further acknowledge and agree that nothing contained in this Agreement shall prohibit or restrict any F-Star Company
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from taking any action necessary or appropriate (including marketing efforts) in accordance with applicable securities laws and in accordance with the terms and conditions hereof and the Pre-Closing Financing Agreements, to consummate the F-Star Pre-Closing Financing on the terms specified in the F-Star Pre-Closing Financing Agreements prior to the Closing.
Upon the reasonable request of F-Star and at F-Stars sole cost and expense, Company shall provide reasonable access to Company management and the books and records of Company during normal business hours upon reasonable advance notice for the purpose of permitting any potential party to the F-Star Pre-Closing Financing Agreements to review the business and affairs of Company, subject to the entry by such potential party into a customary non-disclosure and standstill agreement with Company.
ADDITIONAL AGREEMENTS
6.1 Registration Statement; Proxy Statement.
(a) On or before the later of (X) thirty (30) days after the date of this Agreement, or (Y) ten (10) days after Companys receipt of the F-Star Financials, (i) Company, in cooperation with F-Star, shall prepare and file with the SEC a preliminary proxy statement relating to the Company Stockholders Meeting to be held in connection with the Contemplated Transactions (the definitive form of such proxy statement, together with any amendments thereof or supplements thereto, the Proxy Statement) and (ii) Company, in cooperation with F-Star, shall prepare and file with the SEC a registration statement on Form S-4 (the Form S-4), in which the Proxy Statement shall be included as a part (the Proxy Statement and the Form S-4, collectively, the Registration Statement), in connection with the registration under the Securities Act of the shares of Company Common Stock to be issued in the Contemplated Transactions. Company will, reasonably promptly following the receipt thereof, make available to F-Star any SEC correspondence related to the Registration Statement. Each of Company and F-Star shall use their commercially reasonable efforts to cause the Registration Statement to become effective as promptly as practicable, and shall take all or any action required under any applicable federal, state, securities and other Legal Requirements in connection with the issuance of shares of Company Common Stock in the Contemplated Transactions. Each of Company, F-Star and Sellers shall furnish all information concerning such Party, such Partys Subsidiaries and such Partys directors, executive officers and shareholders, as applicable, to the other parties as the other parties may reasonably request in connection with such actions and the preparation of the Registration Statement. Company covenants and agrees that the Registration Statement (and the letter to stockholders, notice of meeting and form of proxy included therewith) will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading. F-Star covenants and agrees that the information supplied by F-Star to Company for inclusion in the Registration Statement will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make such information, in light of the circumstances under which they were made, not misleading. Notwithstanding the foregoing, Company makes no covenant, representation or warranty with respect to statements made in the Registration Statement (and the letter to stockholders, notice of meeting and form of proxy included therewith), if any, based on information provided by or on behalf of F-Star or any of its Representatives for inclusion therein. Company shall use commercially reasonable efforts to cause the Proxy Statement to be mailed to its stockholders as promptly as practicable (but within five (5) Business Days) after the Registration Statement is declared effective by the SEC. If Company or F-Star become aware of any event or information that, pursuant to the Securities Act or the Exchange Act, should be disclosed in an amendment or supplement to the Registration Statement, then such party shall promptly inform the other parties thereof and shall cooperate with such other parties in filing such amendment or supplement with the SEC and, if appropriate, in mailing such amendment or supplement to the Company Stockholders.
(b) Notwithstanding anything to the contrary stated above, prior to filing and mailing, as applicable, the Registration Statement (or any amendment or supplement thereto) or responding to any comments of the SEC with respect thereto, Company shall provide F-Star a reasonable opportunity to review and comment on such
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document or response and shall discuss with F-Star and include in such document or response, comments reasonably and promptly proposed by F-Star. Company will advise F-Star, promptly after Company receives notice thereof, of the time when the Registration Statement has become effective or any supplement or amendment has been filed, of the issuance of any stop order or the suspension of the qualification of Company Common Stock for offering or sale in any jurisdiction, of the initiation or threat of any proceeding for any such purpose, or of any request by the SEC for the amendment or supplement of the Registration Statement or for additional information.
6.2 Company Stockholders Meeting.
(a) Company will take all action necessary under applicable Legal Requirements to call, give notice of and hold a meeting of the holders of Company Capital Stock (the Company Stockholders Meeting) to approve the Company Stockholder Approval Matters. The Company Stockholders Meeting will be held as promptly as practicable following the effective date of the Registration Statement (on a date selected by Company in consultation with F-Star) but in no event later than forty-five (45) days after the effective date of the Registration Statement; provided, however, notwithstanding anything to the contrary contained herein, if on the date of the Company Stockholders Meeting, or a date preceding the date on which the Company Stockholders Meeting is scheduled, Company reasonably believes that (i) it will not receive proxies sufficient to obtain the required approval of the holders of Company Capital Stock at the Company Stockholders Meeting with respect to all of the Company Stockholder Approval Matters, whether or not a quorum would be present at the Company Stockholders Meeting, or (ii) it will not have sufficient shares of Company Capital Stock represented (whether in person or by proxy) to constitute a quorum necessary to conduct the business of the Company Stockholders Meeting, Company shall have the right, in its sole and absolute discretion, to postpone or adjourn the Company Stockholders Meeting as long as the date of the Company Stockholders Meeting is not postponed or adjourned more than an aggregate of thirty (30) consecutive calendar days in connection with such postponement or adjournment. Company will engage Innisfree M&A Incorporated (or such other proxy solicitor reasonably acceptable to F-Star) as proxy solicitor to assist in the solicitation of proxies in connection with the Company Stockholders Meeting and will ensure that such proxies are solicited in compliance in all material respects with all applicable Legal Requirements. Company shall use its commercially reasonable efforts to solicit from the Company Stockholders proxies in favor of the Company Stockholder Approval Matters.
(b) Subject to Section 6.2(c): (i) the board of directors of Company will recommend that its stockholders vote to approve the Company Stockholder Approval Matters (such recommendation, the Company Board Recommendation); (ii) the Proxy Statement will include the Company Board Recommendation; (iii) the Company Board Recommendation will not be withdrawn or modified, and no resolution by the board of directors of Company or any committee thereof to withdraw or modify the Company Board Recommendation will be adopted or publicly proposed by Company; (iv) following the public disclosure of an Acquisition Proposal, the board of directors of Company will not fail to publicly reaffirm or republish the Company Board Recommendation within five (5) Business Days after F-Star so requests in writing; and (v) the board of directors of Company will not fail to recommend against acceptance of, or take a neutral position with respect to, a tender or exchange offer related to an Acquisition Proposal in any position taken pursuant to Rules 14d-9 and 14e-2 under the Exchange Act.
(c) Notwithstanding anything to the contrary contained in Section 6.2(b), at any time prior to the Company Stockholder Approval, the Company Board Recommendation may be withdrawn or modified (a Company Change in Recommendation) if the board of directors of Company concludes in good faith, after consultation with Companys outside legal counsel and financial advisors, that as a result of Companys receipt of an Acquisition Proposal that was not the result of a breach of Section 6.10(a)(i) and that the board of directors of Company has determined in good faith, after consultation with Companys outside legal and financial advisors, constitutes a Superior Offer, a failure to make a Company Change in Recommendation is reasonably likely to constitute a breach of the fiduciary duties of the board of directors of Company to the Company Stockholders under applicable Legal Requirements; provided, however, that prior to Company taking any action permitted under this Section 6.2(c), Company shall provide F-Star and Sellers with four (4) Business Days prior written notice (the Notice Period) advising F-Star and Sellers that it intends to
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effect such withdrawal or modification to the Company Board Recommendation and specifying, in reasonable detail, the reasons therefor (including the information required by Section 6.10(a)(ii)), and during such Notice Period, (i) Company shall negotiate, and cause its Representatives to negotiate, with F-Star in good faith (to the extent F-Star wishes to negotiate) to enable F-Star to determine whether to propose revisions to the terms of this Agreement such that it would obviate the need for Companys board of directors to effect such withdrawal or modification, and (ii) Company shall consider in good faith any proposal by F-Star or Sellers to amend the terms and conditions of this Agreement in a manner that would make F-Stars or Sellers modified proposal at least as favorable to Company and its stockholders as the Superior Offer. If the board of directors of Company determines that, in accordance with clause (ii) of the immediately preceding sentence, F-Stars or Sellers modified proposal is at least as favorable to Company and the Company Stockholders as the Superior Offer (after taking account any amendment or modification to the terms of such Superior Offer) then the board of directors of Company shall recommend such modified proposal to the Company Stockholders; provided, however, that in the event of any amendment or modification to the terms of such Superior Offer makes it more favorable than the latest modified proposal by F-Star or Sellers, the notification provisions above shall again apply, except that the Notice Period shall be three (3) Business Days rather than four (4) Business Days. It is expressly understood and agreed by all Parties that a stop, look and listen or similar communication by the board of directors of Company, or a committee thereof, to the Companys Stockholders pursuant to Rule 14d-9(f) of the Exchange Act shall not be deemed a Company Change in Recommendation.
(d) Companys obligation to call, give notice of and hold the Company Stockholders Meeting will not be limited or otherwise affected by any Company Change in Recommendation.
(e) Nothing contained in this Agreement will prohibit Company or its board of directors from making any disclosure or statement pursuant to Rules 14d-9 and 14e-2(a) promulgated under the Exchange Act; provided, however, that no Company Change in Recommendation shall be made except in accordance with the terms of this Agreement.
6.3 Access to Information; Confidentiality. During the Pre-Closing Period, and upon reasonable notice and subject to restrictions contained in confidentiality agreements to which such Party is subject, Company and F-Star each shall, and shall use commercially reasonable efforts to cause such Partys Representatives to, afford to the Representatives of the other, reasonable access, during the Pre-Closing Period, to all its properties, books, contracts, commitments and records (including Tax records) and, during such period, Company and F-Star each will furnish promptly to the other all information concerning its business, properties and personnel as such other Party may reasonably request, and each will make available to the other the appropriate individuals (including attorneys, accountants and other professionals) for discussion of the others business, properties and personnel as either Party may reasonably request; provided, that, in each case, such access may be subject to such reasonable restrictions as Company or F-Star, as applicable, reasonably determines, in light of the coronavirus (COVID-19) pandemic (taking into account any shelter-in-place or similar order issued by a Governmental Body). Any investigation conducted by Company or F-Star pursuant to this Section 6.3 shall be conducted in such a manner as not to interfere unreasonably with the conduct of the business of the other Party. Each Party will keep such information confidential in accordance with the terms of the currently effective confidentiality agreement (the Confidentiality Agreement) between F-Star and Company, which agreements the parties agree will continue in full force following the date of this Agreement. Notwithstanding anything herein to the contrary in this Section 6.3, no access or examination contemplated by this Section 6.3 shall be permitted to the extent that it would require any Party or its Subsidiaries to waive the attorney-client privilege or attorney work product privilege, or violate any applicable Legal Requirement; provided, that such Party or its Subsidiary: (i) shall be entitled to withhold only such information that may not be provided without causing such violation or waiver; (ii) shall provide to the other Party all related information that may be provided without causing such violation or waiver (including, to the extent permitted, redacted versions of any such information); and (iii) shall enter into such effective and appropriate joint-defense agreements or other protective arrangements as may be reasonably requested by the other Party in order that all such information may be provided to the other Party without causing such violation or waiver.
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6.4 Regulatory Approvals and Related Matters.
(a) Each Party will promptly file all notices, reports and other documents required to be filed by such Party with any Governmental Body with respect to the Contemplated Transactions, and submit promptly any additional information requested by any such Governmental Body. Each of F-Star and Company will notify the other promptly upon the receipt of (and, if in writing, share a copy of) any communication received by such Party from, or given by such Party to, any Governmental Bodies and of any material communication received or given in connection with any proceeding by a private party, in each case in connection with the Contemplated Transactions. Without limiting the generality of the foregoing, the Parties shall, promptly after the date of this Agreement, prepare and file any notification or other document required to be filed in connection with the Acquisition under any applicable foreign Legal Requirement relating to antitrust or competition matters. Company and F-Star shall respond as promptly as is practicable to respond in compliance with: (i) any inquiries or requests received from the Federal Trade Commission or the Department of Justice for information or documentation; and (ii) any inquiries or requests received from any state attorney general, foreign antitrust or competition authority or other Governmental Body in connection with antitrust or competition matters. Each of F-Star and Company will give the other prompt notice of the commencement or known threat of commencement of any Legal Proceeding by or before any Governmental Body with respect to any of the Contemplated Transactions, will keep the other reasonably informed as to the status of any such Legal Proceeding or threat, and, in connection with any such Legal Proceeding, will permit authorized representatives of the other to be present at each meeting or conference relating to any such Legal Proceeding and to have access to and be consulted in connection with any document, opinion or proposal made or submitted to any Governmental Body in connection with any such Legal Proceeding.
(b) Upon the terms and subject to the conditions set forth in this Agreement and subject to this Section 6.4(b), each of the Parties agrees to use its commercially reasonable efforts to take, or cause to be taken, all actions necessary or advisable to satisfy each of the conditions set forth in Article 7, consummate the Acquisition and make effective the other Contemplated Transactions (provided that no Party will be required to waive any of the conditions set forth in Article 7, as applicable, as part of its obligations to consummate the Contemplated Transactions). Without limiting the generality of the foregoing, but subject to this Section 6.4(b), each Party agrees to use its commercially reasonable efforts to: (i) as promptly as practicable, prepare and file all filings (if any) and give all notices (if any) required to be made and given by such Party in connection with the Contemplated Transactions; (ii) obtain each Consent (if any) required to be obtained (pursuant to any applicable Legal Requirement or Contract, or otherwise) by such Party in connection with the Contemplated Transactions; and (iii) lift any restraint, injunction or other legal bar to the Contemplated Transactions.
6.5 Director Indemnification and Insurance.
(a) From the Closing through the sixth (6th) anniversary of the Closing Date, Company shall indemnify and hold harmless each person who is now, or has been at any time prior to the date hereof, or who becomes prior to the Closing, a director or officer of any F-Star Company or Acquiring Company (the D&O Indemnified Parties), against all claims, losses, Liabilities, damages, judgments, fines and reasonable fees, costs and expenses, including attorneys fees and disbursements, incurred in connection with any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, arising out of or pertaining to the fact that the D&O Indemnified Party is or was a director or officer of an F-Star Company or Acquiring Company, whether asserted or claimed prior to, at or after the Closing, to the fullest extent permitted under applicable Legal Requirement, and such F-Star Companys or Acquiring Companys Organizational Documents, as applicable. Each D&O Indemnified Party will, to the fullest extent permitted under applicable Legal Requirements and the F-Star Companys or Acquiring Companys Organizational Documents, as applicable, be entitled to advancement of expenses incurred in the defense of any such claim, action, suit, proceeding or investigation from each of the applicable Acquiring Company and the applicable F-Star Company, jointly and severally, upon receipt by Company or F-Star from the D&O Indemnified Party of a request therefor; provided that any person to whom expenses are advanced provides an undertaking, to the extent then required by applicable Legal Requirement, to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
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(b) From and after the Closing, Company shall maintain directors and officers liability insurance policies (at F-Stars expense) for Company and its Subsidiaries, including F-Star and its Subsidiaries, with an effective date as of the Closing Date, on commercially available terms and conditions and with coverage limits customary for U.S. public companies similarly situated to Company. In addition, prior to the Closing, Company shall purchase and fully pre-pay (at Companys expense) a tail endorsement for the Companys existing directors and officers insurance policies and Companys existing fiduciary liability insurance policies, in each case, that provides a six-year extended reporting period from and after the Closing for claims first made against an individual insured for any alleged or actual wrongful act(s) that occurred prior to the Closing (including in connection with this Agreement or the Contemplated Transactions) (the D&O Tail). In the event the D&O Tail is not available to be purchased from the Companys existing directors and officers and/or fiduciary liability insurer(s) then the Company shall obtain and fully pre-pay (at Companys expense) the premium for directors and officers and fiduciary liability insurance policies which would be the equivalent of the D&O Tail with coverage that is substantially equivalent to and in any event not less favorable than the Companys current existing directors and officers and fiduciary liability insurance and which cannot be cancelled for any reason. Additionally, F-Star will obtain run-off tail endorsements to its current directors and officers insurance policies (or runoff or tail policies of at least the same coverage containing terms and conditions no less advantageous to the current and all former directors and officers of F-Star) with respect to acts or failures to act prior to the Closing. Company shall (at F-Stars expense) maintain products liability and human clinical trial liability insurance policies for Company and its Subsidiaries with an effective date as of the Closing Date, on commercially available terms and conditions and with coverage limits customary for U.S. public companies similarly situated to Company, and providing coverage for bodily injury or property damage caused by Companys or its Subsidiaries products, including bodily injury or property damage occurring in connection with human clinical trials, anywhere in the world. In addition, prior to the Closing, Company shall purchase and fully pre-pay (at F-Stars expense) a tail endorsement to Companys existing global products liability and human clinical trial liability insurance policy that provides a six-year extended reporting period from and after the Closing for claims for alleged bodily injury or property damage that occurred prior to the Closing in connection with any of the Acquiring Companies products, including any alleged bodily injury or property damage occurring in connection with human clinical trials (the Clinical Trial Tail). In the event the Clinical Trial Tail is not available to be purchased from the Companys existing global products liability and human clinical trial liability insurer, then Company shall obtain and fully pre-pay (at F-Stars expense) the premium for products liability and human clinical trial liability insurance which would be the equivalent of the Clinical Trial Tail with coverage that is substantially equivalent to and in any event not less favorable than Companys current existing products liability and human clinical trial liability insurance and which cannot be cancelled for any reason. Company shall pay all reasonable expenses, including reasonable attorneys fees, that may be incurred by the Persons referred to in this Section 6.5 in connection with their enforcement of their rights provided in this Section 6.5 but only if and to the extent that such Persons are successful on the merits of such enforcement action.
(c) The provisions of this Section 6.5 are intended to be in addition to the rights otherwise available to the current and former officers and directors of F-Star and Company by law, charter, statute, bylaw or agreement, and shall operate for the benefit of, and shall be enforceable by, each of the D&O Indemnified Parties, their heirs and their representatives.
(d) This Section 6.5 is intended to be (i) for the benefit of, and shall be enforceable by, the D&O Indemnified Parties, their heirs and personal representatives and shall be binding on F-Star, Company and their respective successors and assigns, (ii) in addition to, and not in substitution for, any other rights to indemnification or contribution that any D&O Indemnified Party may have by contract or otherwise, including indemnification agreements that Company or F-Star have entered into with any of their respective directors or officers, and (iii) may not be amended, altered or repealed after the Closing without the prior written consent of the affected D&O Indemnified Party (provided that, for the avoidance of doubt, such amendment, alteration or repeal prior to the Closing shall be governed by Section 9.2).
(e) In the event Company or F-Star or any of their respective successors or assigns (i) consolidates with or merges into any other Person and shall not be the continuing or surviving corporation or entity of such
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consolidation or merger, or (ii) transfers all or substantially all of its properties and assets to any Person, then, and in each such case, proper provision shall be made so that the successors and assigns of Company or F-Star, as the case may be, shall succeed to the obligations set forth in this Section 6.5.
6.6 Notification of Certain Matters.
(a) Company will give prompt notice to F-Star and each Seller, F-Star will give prompt notice to Company and each Seller will give prompt notice to F-Star and Company, of (i) the occurrence, or non-occurrence, of any event the occurrence, or non-occurrence, of which would be likely to cause any representation or warranty contained in this Agreement to be untrue or inaccurate in a manner that causes the condition set forth in Section 7.2(b) or Section 7.3(b), as applicable, not to be satisfied, and (ii) any failure of Company, F-Star or such Seller, as the case may be, materially to comply with or satisfy any covenant, condition or agreement to be complied with or satisfied by it hereunder.
(b) Company, F-Star and each Seller will give prompt notice to the other of: (i) any notice or other communication from any Person alleging that the consent of such Person is or may be required in connection with the Contemplated Transactions; (ii) any notice or other communication from any Governmental Body in connection with the Contemplated Transactions; (iii) any litigation relating to or involving or otherwise affecting Company, F-Star or such Seller that relates to the Contemplated Transactions; (iv) the occurrence of a default or event that, with notice or lapse of time or both, will become a default under a Company Contract or an F-Star Contract, as applicable; and (v) any change that would be considered reasonably likely to result in a Company Material Adverse Effect or an F-Star Material Adverse Effect, as applicable.
(c) No notification given to a Party pursuant to this Section 6.6 shall change, limit or otherwise affect any of the representations, warranties, covenants or obligations of the Party providing such notification or any of such Partys Subsidiaries contained in this Agreement or the Company Disclosure Schedule or the F-Star Disclosure Schedule, as appropriate, for purposes of Section 7.2 or Section 7.3, as appropriate. The failure by a Party to give a notification required under this Section 6.6 or any delay in providing such a required notification shall not be treated as a breach of covenant for the purposes of Section 7.2(a) or Section 7.3(a), as applicable, unless such failure or delay results in material prejudice to another Party.
6.7 Public Announcements. The initial press release relating to this Agreement shall be a joint press release, and thereafter F-Star and Company will consult with each other before issuing any press release or otherwise making any public statements (including disclosure under the Securities Act or Exchange Act) with respect to the Acquisition or this Agreement. No Party shall, and no Party shall permit any of its Subsidiaries or Representatives to, issue any press release or make any such public statement (to any customers or employees of such Party, to the public or otherwise) relating to the Acquisition without the prior consent of, in the case of (i) Company, F-Star, (ii) F-Star, Company or (iii) a Seller, F-Star and Company, which will not be unreasonably withheld, conditioned or delayed; provided, however, that (A) on the advice of outside legal counsel, Company may issue a press release or public statement without the consent of F-Star if Company, with the advice of outside legal counsel, reasonably determines is required by Legal Requirements or otherwise made in connection with a Company Change in Recommendation or the termination of this Agreement and (B) other than a press release announcing a Company Change in Recommendation or the termination of this Agreement or a subsequent press release relating to such Company Change in Recommendation or termination, any press release or public statement relating to the Acquisition to be issued without the consent of F-Star pursuant to clause (A) shall be subject to reasonable prior notice to and review of F-Star and Company shall consider any and all reasonable comments of F-Star thereon in good faith. Notwithstanding the foregoing, each of Company and F-Star may make public statements in response to specific questions by the press, analysts, investors or those attending industry conferences or financial analyst conference calls, so long as any such statements are consistent with previous press releases, public disclosures or public statements made by Company or F-Star in compliance with this Section 6.7 and such statements do not result in the requirement to amend or supplement the Registration Statement or the Proxy Statement and are not deemed to be a free-writing prospectus as such term is defined under the Securities Act. Further, Company may make issue one or more press releases or make public statements relating to the Approved Development Transaction or any Permitted Disposition.
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6.8 Conveyance Taxes. Each Party will cooperate in the preparation, execution and filing of all returns, questionnaires, applications or other documents regarding any real property transfer or gains, sales, use, transfer, value added, stock transfer and stamp Taxes, any transfer, recording, registration and other fees, and any similar Taxes which become payable in connection with the Contemplated Transactions that are required or permitted to be filed on or before the Closing or in relation to stamp Taxes in respect of the transfers of (or agreement to transfer) the F-Star Shares after the Closing. Without limiting the generality of the forgoing, Company shall not have any Liability for any Tax incurred by F-Star or any Seller in connection with the Contemplated Transactions.
6.9 Board of Directors and Officers. Until successors are duly elected or appointed and qualified in accordance with applicable Legal Requirements, the Parties shall use reasonable best efforts and take all necessary action so that the Persons listed in Schedule 6.9 are elected or appointed, as applicable, to the positions of officers and directors of Company, as set forth therein, to serve in such positions effective as of the Closing. If any Person listed in Schedule 6.9 is unable or unwilling to serve as officer or director of Company, as set forth therein, the Party appointing such Person (as set forth on Schedule 6.9) shall designate a successor.
6.10 Non-Solicitation by Company and F-Star.
(a) Non-Solicitation by Company.
(i) Prior to the receipt of Company Stockholder Approval, Company will not and will not authorize or permit any of its Subsidiaries or authorize any Representative of any Acquiring Company, directly or indirectly, to (i) solicit or initiate, or knowingly encourage, induce or facilitate the making, submission or announcement of any Acquisition Proposal or take any action that would reasonably be expected to lead to an Acquisition Proposal, (ii) furnish any nonpublic information regarding any Acquiring Company to any Person in connection with or in response to an Acquisition Proposal or an inquiry or indication of interest that would reasonably be expected to lead to an Acquisition Proposal, (iii) engage in discussions or negotiations with any Person with respect to any Acquisition Proposal, (iv) approve, endorse or recommend any Acquisition Proposal or (v) enter into any letter of intent or similar document or any agreement providing for or otherwise relating to any Acquisition Transaction (other than an Acceptable Company Confidentiality Agreement); provided, however, that prior to obtaining the Company Stockholder Approval, Company may furnish nonpublic information regarding the Acquiring Companies to, and enter into discussions with, any Person in response to an Acquisition Proposal that, after consultation with its outside legal and financial advisors, Companys board of directors determines in good faith is, or is reasonably expected to result in, a Superior Offer (and is not withdrawn) if (1) such Acquisition Proposal was not the result of a breach of this Section 6.10(a)(i), (2) the board of directors of Company concludes in good faith, after consultation with its outside legal counsel, that a failure to take such action is reasonably likely to constitute a breach of the fiduciary duties of the board of directors of Company to the Company Stockholders under applicable Legal Requirements, (3) prior to furnishing any such information to, or entering into discussions with, such Person, Company gives F-Star written notice of the identity of such Person and of Companys intention to furnish information to, or enter into discussions with, such Person, and Company receives from such Person an executed confidentiality agreement on terms no more favorable to Company than the confidentiality agreement between F-Star and Company and containing customary limitations on the use and disclosure of all nonpublic written and oral information furnished to such Person by or on behalf of Company (an Acceptable Company Confidentiality Agreement), and (4) prior to or simultaneously with furnishing any such information to such Person, Company furnishes or makes available such nonpublic information to F-Star (to the extent such nonpublic information has not been previously furnished or made available by Company to F-Star). Company shall, and shall cause its Subsidiaries and instruct its and their respective Representatives to, promptly upon the execution of this Agreement cause to be terminated any solicitation, encouragement, discussion or negotiation with or involving any Person (other than F-Star, Sellers and their respective Affiliates) conducted heretofore by Company or any Subsidiary thereof or any of its or their respective Representatives, with respect to an Acquisition Proposal or which could reasonably be expected to lead to an Acquisition Proposal, and,
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in connection therewith, Company will immediately discontinue access by any Person (other than F-Star, Sellers and their respective Affiliates) to any data room (virtual or otherwise) established by Company or its Representatives for such purpose. Without limiting the generality of the foregoing, Company acknowledges and agrees that in the event any Representative of Company (or its Subsidiaries) takes any action that, if taken by Company (or its Subsidiaries), would constitute a breach of this Section 6.10(a)(i), the taking of such action by such Representative will be deemed to constitute a breach of this Section 6.10(a)(i) by Company for purposes of this Agreement.
(ii) Prior to the receipt of Company Stockholder Approval, Company will promptly (and in no event later than forty-eight (48) hours after receipt of any Acquisition Proposal or any inquiry or indication of interest that Company reasonably expects to lead to an Acquisition Proposal) advise F-Star orally and in writing of any Acquisition Proposal or inquiry or indication of interest that Company reasonably expects to lead to an Acquisition Proposal (including the identity of the Person making or submitting such Acquisition Proposal, inquiry or indication of interest, and the material terms thereof) that is made or submitted by any Person during the Pre-Closing Period. Company will keep F-Star informed, on a prompt basis, in all material respects with respect to the status of any such Acquisition Proposal, inquiry or indication of interest and any modification or proposed modification thereto.
(b) Non-Solicitation by F-Star.
(i) Prior to the receipt of Company Stockholder Approval, F-Star will not and will not authorize or permit any of its Subsidiaries or authorize any Representative of any F-Star Company, directly or indirectly, to (v) solicit or initiate, or knowingly encourage, induce or facilitate the making, submission or announcement of any F-Star Acquisition Proposal or take any action that would reasonably be expected to lead to an F-Star Acquisition Proposal, (w) furnish any nonpublic information regarding any F-Star Company to any Person in connection with or in response to an F-Star Acquisition Proposal or an inquiry or indication of interest that would reasonably be expected to lead to an F-Star Acquisition Proposal, (x) engage in discussions or negotiations with any Person with respect to any F-Star Acquisition Proposal, (y) approve, endorse or recommend any F-Star Acquisition Proposal or (z) enter into any letter of intent or similar document or any agreement providing for or otherwise relating to any transaction described in the definition of F-Star Acquisition Proposal, taking into account the proviso in such definition. F-Star shall, and shall cause its Subsidiaries and instruct its and their respective Representatives to, promptly upon the execution of this Agreement cause to be terminated any solicitation, encouragement, discussion or negotiation with or involving any Person (other than Company and its respective Affiliates) conducted heretofore by F-Star or any Subsidiary thereof or any of its or their respective Representatives, with respect to an F-Star Acquisition Proposal or which could reasonably be expected to lead to an F-Star Acquisition Proposal, and, in connection therewith, F-Star will immediately discontinue access by any Person (other than Company and its respective Affiliates) to any data room (virtual or otherwise) established by F-Star or its Representatives for such purpose. Without limiting the generality of the foregoing, F-Star acknowledges and agrees that in the event any Representative of F-Star (or its Subsidiaries), takes any action that, if taken by F-Star (or its Subsidiaries) would constitute a breach of this Section 6.10(b)(i), the taking of such action by such Representative will be deemed to constitute a breach of this Section 6.10(b)(i) by F-Star for purposes of this Agreement.
(ii) Prior to the receipt of Company Stockholder Approval, F-Star will promptly (and in no event later than forty-eight (48) hours after receipt of any F-Star Acquisition Proposal or any inquiry or indication of interest that F-Star reasonably expects to lead to an F-Star Acquisition Proposal) advise Company orally and in writing of any F-Star Acquisition Proposal or inquiry or indication of interest that F-Star reasonably expects to lead to an F-Star Acquisition Proposal (including the identity of the Person making or submitting such F-Star Acquisition Proposal, inquiry or indication of interest, and the material terms thereof) that is made or submitted by any Person during the Pre-Closing Period. F-Star will keep Company informed, on a prompt basis, in all material respects with respect to the status of
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any such F-Star Acquisition Proposal, inquiry or indication of interest and any modification or proposed modification thereto.
6.11 Restrictions on Transfer.
(a) Each Seller covenants and agrees for the benefit of Company that during the Pre-Closing Period, such Seller will not, directly or indirectly:
(i) offer, sell, transfer (whether by merger, operation of law or otherwise), pledge, hypothecate, encumber, assign, tender or otherwise dispose of, or enter into any contract, option or other arrangement or understanding, directly or indirectly, with respect to the sale, transfer, pledge, hypothecation, encumbrance, assignment, tender or other disposition of any shares in the F-Star Share Capital, any security convertible into or exercisable or exchangeable for, or that represents the right to receive, shares in the F-Star Share Capital (including any 2019 Loan Note), or any interest in any of the foregoing; or
(ii) take any other action with respect to shares in the F-Star Share Capital, any security convertible into or exercisable or exchangeable for, or that represents the right to receive, shares in the F-Star Share Capital, or any interest in any of the foregoing, that would in any way restrict, limit, or interfere with the performance of such Sellers obligations hereunder or the Contemplated Transactions.
(b) Notwithstanding the foregoing, any Seller may assign or transfer shares of F-Star Share Capital or the 2019 Loan Notes or any other security convertible into or exercisable or exchangeable for, or that represents the right to receive, shares in the F-Star Share Capital, or any interest in any of the foregoing, to any Permitted Transferee, provided, however, that (i) such assignment or transfer is made in accordance with applicable Legal Requirements and in compliance with any contractual restriction upon the assignment or transfer of such shares, securities or interests, including, where applicable, restrictions contained in the Articles of Association, the Shareholders Agreement or the 2019 Loan Note Instrument, (ii) such Permitted Transferee has first executed a Joinder Agreement substantially in the form attached hereto as Exhibit G (Joinder Agreement), and (iii) if the Seller effecting the assignment or transfer is subject to a Seller Lock-Up Agreement, such Permitted Transferee has executed and delivered to Company a Seller Lock-Up Agreement with respect to the shares, securities or interests assigned or transferred to it. Permitted Transferee shall have the meaning ascribed to it in the Articles of Association.
6.12 Joinder Agreements; Seller Lock-Up Agreements. F-Star shall cause each Person who is not already a Party and who acquires shares in the F-Star Share Capital or 2019 Loan Notes from F-Star subsequent to the date hereof to become a Party by executing a Joinder Agreement. F-Star shall use commercially reasonable efforts to cause the Sellers listed on Schedule III-B to execute and deliver Seller Lock-up Agreements.
6.13 Listing; Symbol. Company will use its commercially reasonable efforts to cause (a) the shares of Company Common Stock to be issued in connection with the Acquisition to be approved for listing (subject to notice of issuance) on Nasdaq at or prior to the Closing and (b) the Company Common Stock to be listed on Nasdaq under a symbol chosen by F-Star prior to the date hereof at or as promptly as possible after the Closing.
6.14 Section 16 Compliance. Subject to the following sentence, prior to the Closing, Company will take all such steps as may be required (to the extent permitted under applicable Legal Requirements and no-action letters issued by the SEC) to cause any acquisition of Company Common Stock (including derivative securities with respect to Company Common Stock) pursuant to this Agreement by each individual who is or will be subject to the reporting requirements of Section 16(a) of the Exchange Act with respect to Company, to be exempt under Rule 16b-3 under the Exchange Act. At least thirty (30) days prior to the Closing Date, F-Star will furnish the following information to Company for each individual who, immediately after the Closing, is reasonably expected to become subject to the reporting requirements of Section 16(a) of the Exchange Act with respect to Company: (a) the number of F-Star Ordinary Shares expected to be held by such individual immediately following the Share Conversion and exchanged for shares of Company Common Stock pursuant to the Acquisition; (b) the number of other derivative securities (if any) with respect to F-Star Shares held by such
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individual and expected to be converted into shares of Company Common Stock or derivative securities with respect to Company Common Stock in connection with the Acquisition; and (c) CCC and CIK codes for purposes of submitting SEC Section 16 filings.
6.15 F-Star Share Incentives. Prior to the Closing, the board of directors of F-Star (and, in the case of the matters described in Sections 6.15(a)(i) to (xi) below, the board of directors of Company) shall have adopted appropriate resolutions (in the case of resolutions to be adopted by the board of directors of Company, such resolutions to be provided by F-Star) and taken all other actions necessary and appropriate (in the case of the board of directors of Company, only to the extent specifically directed by F-Star) to provide for the following matters and actions described in this Section 6.15.
(a) Options granted under the F-Star EIP (F-Star EIP Options) and restricted share units granted under the F-Star EIP (F-Star RSUs):
(i) The board of directors of Company shall (conditional upon and effective at the Closing) assume the F-Star EIP without amendment, except that (a) references in the rules of that plan to F-Star Therapeutics Limited shall be references to Company and (b) references in the rules of that plan to Ordinary Shares shall be references to shares of Company Common Stock (such assumed plan to be referred to in this Section 6.15 as the Assumed Plan).
(ii) The board of directors of Company shall (conditional upon Closing and effective immediately after the Closing) grant to each holder of F-Star EIP Options a replacement option on the basis described in Sections 6.15(a)(iii) to (viii), (xiii) to (xv) below (a Replacement EIP Option).
(iii) Each Replacement EIP Option shall be granted under the Assumed Plan and shall be an option to subscribe for or purchase shares of Company Common Stock.
(iv) Each Replacement EIP Option shall be granted in consideration of the holder of the F-Star EIP Option that it is intended to replace (the Original EIP Option) releasing that Original EIP Option in full pursuant to an agreement in form and substance prepared by and satisfactory to F-Star.
(v) The aggregate exercise price payable to exercise (in full) each Replacement EIP Option shall be the same as the aggregate exercise price payable to exercise (in full) the Original EIP Option that it replaces; provided, however, that the exercise price with respect to a Replacement EIP Option may be adjusted with respect to any US Option to the extent that excess of the aggregate fair market value of the shares of Company Common Stock subject to the Replacement EIP Option immediately after the Closing over the aggregate exercise price of such Replacement EIP Option exceeds the excess of the aggregate fair market value of all shares subject to the Original EIP Option immediately before the Closing over the aggregate exercise price of such Original EIP Option. For purposes of this Agreement, a US Option shall mean any F-Star EIP Option granted to United States participants under the F-Star EIP.
(vi) The number of shares of Company Common Stock issuable on exercise (in full) of each Replacement EIP Option shall be calculated by applying the Exchange Ratio to the number of F-Star Ordinary Shares issuable on exercise (in full) of the Original EIP Option that it replaces, and rounding the resulting number down to the nearest whole number of shares of Company Common Stock. All Replacement EIP Options with respect to US Options shall: (a) be on the same terms and conditions as with respect to the Original EIP Option, except to the extent such terms are rendered inoperative by reason of the transactions contemplated by this Agreement; and (b) not give the holders of Replacement EIP Options additional benefits that the holder did not have under the Original EIP Option.
(vii) The vesting schedule applicable to each Replacement EIP Option shall be the same as the vesting schedule applicable to the Original EIP Option that it replaces (and, for these purposes, the date on which vesting of each Replacement EIP Option shall be deemed to have commenced shall be the date on which the Original EIP Option that it replaces shall have commenced vesting).
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(viii) Notwithstanding anything to the contrary in this Section 6.15, the grant of Replacement EIP Options in exchange for the release of Original EIP Options (a) shall be effected in such manner as shall meet the requirements of Part 6 of Schedule 5 to the Income Tax (Earnings and Pensions) Act 2003 (an act of the UK Parliament) so as to ensure that each Replacement EIP Option shall qualify as Replacement Options under the said Part 6 of Schedule 5 to the Income Tax (Earnings and Pensions) Act 2003, and (b) regardless of whether such Original EIP Option qualifies as an incentive stock option within the meaning of Section 422 of the Code shall be effected in a manner consistent with Treasury Regulation Section 1.424-1, such that the exchange of an Original EIP Option for a Replacement EIP Option shall not constitute a modification of such Original EIP Option for purposes of Section 409A or Section 424 of the Code. For the avoidance of doubt, neither Company nor the board of directors of Company shall be responsible for or have any liability for assuring compliance with the provisions of this clause (viii) other than adoption of the resolutions provided by F-Star and the taking of such action as F-Star specifically directs.
(ix) Company shall also agree to grant to each holder of F-Star RSUs a replacement restricted share unit on the basis described in Sections 6.15(a)(x) to (xiv) below (a Replacement EIP RSU).
(x) Each Replacement EIP RSU shall be granted under the Assumed Plan and shall be a right to acquire shares of Company Common Stock.
(xi) Each Replacement EIP RSU shall be granted in consideration of the holder of the F-Star RSU that it is intended to replace (the Original EIP RSU) releasing that Original EIP RSU in full pursuant to an agreement in form and substance prepared by and satisfactory to F-Star.
(xii) The number of shares of Company Common Stock issuable on vesting (in full) of each Replacement EIP RSU shall be calculated by applying the Exchange Ratio to the number of F-Star Ordinary Shares issuable on vesting (in full) of the Original EIP RSU that it replaces, and rounding the resulting number down to the nearest whole number of shares of Company Common Stock. All Replacement EIP RSUs shall: (a) be on the same terms and conditions as with respect to the Original EIP RSU, except to the extent such terms are rendered inoperative by reason of the transactions contemplated by this Agreement; and (b) not give the holders of Replacement EIP RSUs additional benefits that the holder did not have under the Original EIP RSU.
(xiii) The board of directors of F-Star shall write to all holders of F-Star EIP Options and F-Star RSUs offering the holders of F-Star EIP Options the choice to exchange their F-Star EIP Options for Replacement EIP Options on the basis described in this Section 6.15(a), and offering the holders of F-Star RSUs the choice to exchange their F-Star RSUs for Replacement EIP RSUs on the basis described in this Section 6.15(a). Such offer shall be made in compliance with all applicable Legal Requirements and F-Star hereby indemnifies the Company and its Representatives from and against all Liabilities that result from the failure of F-Star to comply with applicable Legal Requirements in connection therewith.
(xiv) If any holder of any F-Star EIP Option that is an EMI Option (as such term is defined in the rules of the F-Star EIP) fails to accept the offer to exchange their F-Star Option on the basis described in Sections 6.15(a)(i) to (ix) above, the portion of their F-Star Option that shall be unvested as at the Closing shall lapse immediately in accordance with Rule 8.2 (b) (ii) of the rules of the F-Star EIP.
(xv) If any holder of any F-Star EIP Option that is an EMI Option (as such term is defined in the rules of the F-Star EIP) fails to accept the offer to exchange its F-Star Option on the basis described in Section 6.15(a), upon the exercise of the portion of their F-Star Option that shall be vested as at the Closing, F-Star shall immediately exercise its right to procure the compulsory purchase (by Company) of F-Star Ordinary Shares issued upon such exercise in accordance with Article 28 of the Closing Articles of Association as in effect on the Closing Date.
(xvi) If any holder of an F-Star RSU fails to accept the offer to exchange its F-Star RSU on the basis described in Section 6.15(a), upon the vesting of such RSU, F-Star shall immediately exercise its right to procure the compulsory purchase (by Company) of F-Star Ordinary Shares subject to the
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F-Star RSU in accordance with Article 28 of the Closing Articles of Association as in effect on the Closing Date.
(xvii) From and after the Closing, F-Star shall cause Company to take such further action as may be required to effect the transactions specified in this Section 6.15(a).
(b) Options granted under the F-Star Alpha Limited Share Option Scheme (F-Star Alpha Legacy Options):
(i) Company shall not assume the F-Star Alpha Limited Share Option Scheme, and shall not make an offer of replacement options under Rule 12 of the rules of the F-Star Alpha Limited Share Option Scheme.
(ii) The board of directors of F-Star shall exercise its discretion under Rule 11.1 (d) of the rules of the F-Star Alpha Limited Share Option Scheme by issuing a notification to all holders of F-Star Alpha Legacy Options notifying them that they may exercise their F-Star Alpha Legacy Options conditional upon and effective at the Closing in accordance with such Rule 11.1 (d).
(iii) If the holder of any F-Star Alpha Legacy Option fails to exercise their F-Star Alpha Legacy Option on the basis described in Section 6.15(b)(ii) above, such unexercised F-Star Alpha Legacy Option shall cease to be exercisable effective upon Closing, and shall lapse at the expiry of the period of six months following Closing, in accordance with Rule 11.1 (d) of the rules of the F-Star Alpha Limited Share Option Scheme.
(iv) In connection with the exercise of any F-Star Alpha Legacy Options, F-Star shall obtain from each holder of F-Star Alpha Legacy Options that are exercised pursuant to the provisions of this Section 6.15(b) an executed Joinder Agreement pursuant to which such holder shall become a Seller for all purposes hereunder.
(v) If any holder of any F-Star Alpha Legacy Option fails to accept the offer to exercise its F-Star Alpha Legacy Option on the basis described in Section 6.15(b), upon the exercise such F-Star Alpha Legacy Option, F-Star shall immediately exercise its right to procure the compulsory purchase (by Company) of F-Star Ordinary Shares issued upon such exercise in accordance with Article 28 of the Closing Articles of Association as in effect on the Closing Date.
(c) Options granted under the F-Star Beta Limited Share Option Scheme (F-Star Beta Legacy Options):
(i) The Company shall not assume the F-Star Beta Limited Share Option Scheme, and shall not make an offer of replacement options under Rule 12 of the rules of the F-Star Beta Limited Share Option Scheme.
(ii) The board of directors of F-Star shall exercise its discretion under Rule 11.1 (d) of the rules of the F-Star Beta Limited Share Option Scheme by issuing a notification to all holders of F-Star Beta Legacy Options notifying them that they may exercise their F-Star Beta Legacy Options conditional upon and effective at the Closing in accordance with such Rule 11.1 (d).
(iii) If the holder of any F-Star Beta Legacy Option fails to exercise their F-Star Beta Legacy Option on the basis described in Section 6.15(c)(ii) above, such unexercised F-Star Beta Legacy Option shall cease to be exercisable effective upon Closing, and shall lapse at the expiry of the period of six months following the Closing, in accordance with Rule 11.1 (d) of the rules of the F-Star Beta Limited Share Option Scheme.
(iv) In connection with the exercise of any F-Star Beta Legacy Options, F-Star shall obtain from each holder of F-Star Beta Legacy Options that are exercised pursuant to the provisions of this Section 6.15(c) an executed Joinder Agreement pursuant to which such holder shall become a Seller for all purposes hereunder.
(v) If any holder of any F-Star Beta Legacy Option fails to accept the offer to exercise its F-Star Beta Legacy Option on the basis described in Section 6.15(c), upon the exercise such F-Star Beta Legacy Option, F-Star shall immediately exercise its right to procure the compulsory purchase (by
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Company) of F-Star Ordinary Shares issued upon such exercise in accordance with Article 28 of the Closing Articles of Association as in effect on the Closing Date.
(d) Options granted under the F-Star EMI Share Option Scheme (F-Star Gmbh Legacy Options):
(i) The Company shall not assume the F-Star EMI Share Option Scheme, and shall not make an offer of replacement options under Rule 13 of the rules of the F-Star EMI Share Option Scheme.
(ii) The board of directors of F-Star shall exercise its discretion under Rule 12.2 (a) of the rules of the F-Star EMI Share Option Scheme by issuing a notification to all holders of F-Star Gmbh Legacy Options notifying them that they may exercise their F-Star Gmbh Legacy Options conditional upon and effective at the Closing in accordance with such Rule 12.2 (a).
(iii) If the holder of any F-Star Gmbh Legacy Option fails to exercise their F-Star Gmbh Legacy Option on the basis described in Section 6.15(d)(ii) above, such unexercised F-Star Gmbh Legacy Option shall cease to be exercisable effective upon Closing, and shall lapse at the expiry of the period of six months following the Closing, in accordance with Rule 12.2 (a) of the rules of the F-Star EMI Share Option Scheme.
(iv) In connection with the exercise of any F-Star Gmbh Legacy Options, F-Star shall obtain from each holder of F-Star Gmbh Legacy Options that are exercised pursuant to the provisions of this Section 6.15(d) an executed Joinder Agreement pursuant to which such holder shall become a Seller for all purposes hereunder.
(v) If any holder of any F-Star Gmbh Legacy Option fails to accept the offer to exercise its F-Star Gmbh Legacy Option on the basis described in Section 6.15(d), upon the exercise such F-Star Gmbh Legacy Option, F-Star shall immediately exercise its right to procure the compulsory purchase (by Company) of F-Star Ordinary Shares issued upon such exercise in accordance with Article 28 of the Closing Articles of Association as in effect on the Closing Date.
(a) The board of directors of F-Star shall exercise its discretion under Schedule 6 of the ESOP Rollover Agreement dated 7 May 2019 between F-Star Therapeutics, Wilmington Trust SP Services (London) Limited (the Security Trustee) and the Shareholders (as therein defined), inter alia (the F-Star Replacement ESOP Plan Rules) to amend the F-Star Replacement ESOP Plan Rules such that:
(i) the definition of Selling Shareholder be amended to include a shareholder who sells their shares on a Share Sale for consideration in Listed Shares;
(ii) paragraph 6 of Schedule 3 to the F-Star Replacement ESOP Plan Rules be amended to apply the definition of Notional Exit Proceeds to a Share Sale for consideration in Listed Shares;
(iii) paragraph 2 of Schedule 3 to the F-Star Replacement ESOP Plan Rules be amended such that Rules 4(a) and 4(b) of the F-Star Replacement ESOP Plan Rules apply to the case of a Selling Shareholder on Share Sale for consideration in Listed Shares; and
(iv) paragraph 4(d) of the F-Star Replacement ESOP Plan Rules be amended such that the Shareholders pay the Security Trustee acting as trustee of the Beneficiaries the Exit Proceeds within five (5) Business Days of the expiry of the Sale Period (in the case of a Selling Shareholder) or within five (5) Business Days of notification by F-Star to the relevant Shareholder of the amount payable by such Shareholder (in the case of Non-Selling Shareholders).
(b) F-Star undertakes to use reasonable endeavors to procure Security Trustees agreement to amend the Schedule 7 of the ESOP Rollover Agreement dated 7 May 2019 between F-Star, the Security Trustee and the Shareholders (as therein defined) (the Share Charge) such that security over the charged shares in F-Star is released prior to Closing and security is taken over shares of an equivalent or greater value in the Company until the Shareholders obligations are discharged in full under the terms of the F-Star Replacement ESOP Plan.
(c) Such Sellers as are Chargors (as that term is defined in the Share Charge) by their execution and delivery of this Agreement agree to the amendments set out in clause (b) above.
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(d) In this Section 6.16, terms capitalized but not otherwise defined in this Agreement shall have the meanings ascribed to them in the F-Star Replacement ESOP Plan Rules.
6.17 Allocation Certificate. F-Star will prepare and deliver to Company, at least five (5) Business Days prior to the Closing, a certificate signed by a duly authorized director of F-Star in a form reasonably acceptable to Company which sets forth (a) a true and complete list of Sellers immediately prior to the Closing and the number F-Star Shares owned by each such Seller after giving effect to the Conversions and the F-Star Pre-Closing Financing, and (b) the allocation of the Acquisition Consideration among Sellers pursuant to the Acquisition (the Allocation Certificate).
6.18 Employee Matters. No provision of this Agreement shall (i) create any right in any current or former employee or other service provider of F-Star, Company or any of their respective Subsidiaries to continued employment or service or, subject to the terms of any applicable employment, consulting or other agreement, preclude the ability of F-Star, Company or any of their respective Subsidiaries to terminate the employment or service of any employee or service provider for any reason, (ii) require F-Star, Company or any of their respective Subsidiaries to continue any Company Employee Plan or F-Star Employee Plan or prevent the amendment, modification or termination thereof, (iii) confer upon any current or former employee or other service provider of F-Star, Company or any of their respective Subsidiaries, or any beneficiaries or dependents thereof, any rights or remedies under or by reason of this Agreement or (iv) be treated as an amendment to any Company Employee Plan or F-Star Employee Plan.
6.19 Disclosure Schedules. Each of Company and F-Star may in its discretion, for informational purposes only, supplement the information set forth on the Company Disclosure Schedule or F-Star Disclosure Schedule, as applicable, with respect to any matter now existing or hereafter arising that, if existing or occurring at or prior to the date hereof, would have been required to be set forth or described in the Company Disclosure Schedule or F-Star Disclosure Schedule, as applicable, on the date hereof or that is necessary to correct any information in the Company Disclosure Schedule or F-Star Disclosure Schedule, as applicable, which has been rendered inaccurate thereby promptly following discovery thereof. Prior to the Closing, F-Star shall supplement Part 2.2 of the F-Star Disclosure Schedule and Part 4.1 of the F-Star Disclosure Schedule to reflect (A) the addition of Additional Investors and Permitted Transferees as Sellers hereunder and (B) the issuance of F-Star Ordinary Shares in the F-Star Pre-Closing Financing, the Conversions, and the issuance of F-Star Ordinary Shares pursuant to the exercise of F-Star Options or the vesting of F-Star RSUs in accordance with the terms under the F-Star Equity Plans. Except as provided in the preceding sentence, any amended or supplemented disclosure shall not be deemed to modify the representations and warranties of Company, F-Star or Sellers for purposes of Section 7.2(a) and 7.3(a) or any other provision of this Agreement.
6.20 Tax Matters. For U.S. federal income Tax purposes, the Parties intend that the Acquisition shall constitute a tax-free reorganization within the meaning of Section 368(a) of the Code. The Parties shall use their commercially reasonable efforts, and shall cause their respective Affiliates to use their commercially reasonable efforts, to take or cause to be taken any action necessary for the Acquisition to qualify as a reorganization within the meaning of Section 368(a) of the Code and no Party shall take any position on any Tax Return that is inconsistent with such treatment unless otherwise required pursuant to a determination within the meaning of Section 1313(a) of the Code. None of the Parties makes any representation regarding whether the Acquisition will so qualify. The Parties acknowledge that each Party is relying solely on its own Tax advisors in connection with this Agreement, the Acquisition, and the other transactions and agreements contemplated hereby. This Agreement is intended to constitute, and the parties hereto hereby adopt this Agreement as, a plan of reorganization within the meaning of Treasury Regulation Section 1.368-2(g) and 1.368-3(a). Notwithstanding anything herein to the contrary in this Agreement, no Party shall take, or omit to take, any action that could reasonably be expected to prevent or impede the Acquisition from qualifying as a reorganization within the meaning of Section 368(a) of the Code.
6.21 Legends. The Parties agree and acknowledge that the certificates (or uncertificated book-entries, as applicable) representing shares of Company Common Stock issued pursuant to this Agreement shall bear the
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following legend (along with any other legends that may be required under applicable state and federal corporate and securities laws):
THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR UNDER STATE SECURITIES LAWS AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE, DISTRIBUTION OR OTHER TRANSFER, PLEDGE OR HYPOTHECATION MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL SATISFACTORY TO THE ISSUER THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933 OR APPLICABLE STATE SECURITIES LAWS.
6.22 Permitted Dispositions; Approved Development Transaction.
(a) Notwithstanding anything in this Agreement to the contrary (but subject to the provisions set forth in this Section 6.22), Company shall be entitled to divest the Permitted Disposition Assets prior to the Closing in one or more Permitted Dispositions without the consent of F-Star; provided, however, that (i) if such Permitted Disposition results in the creation of ongoing obligations or Liabilities of any Acquiring Company, the terms of such Permitted Disposition shall be reasonably acceptable to F-Star, and (ii) if any such Permitted Disposition is not approved by the Company Stockholders, Company shall confirm (after consultation with Companys outside legal counsel) upon F-Stars request that approval of the Company Stockholders is not required by any Legal Requirement to consummate such Permitted Disposition. Company shall provide to F-Star all documentation in respect of any Permitted Disposition at least five (5) Business Days prior to the consummation of such Permitted Disposition. Notwithstanding anything to the contrary in this Agreement, the Contemplated Transactions (including the Closing) shall not be delayed by or conditioned upon the consummation of any Permitted Disposition.
(b) Notwithstanding anything in this Agreement to the contrary, prior to the Closing Company may enter into an Approved Development Agreement with the counterparty specified in the Term Sheet or any of its controlled Affiliates substantially on the terms and conditions set forth in the Term Sheet subject to the prior written consent of F-Star, such consent not to be unreasonably withheld, delayed or conditioned. Company shall provide to F-Star drafts of the proposed Approved Development Agreement promptly upon receipt and shall consider in good faith all reasonable comments provided by F-Star. Notwithstanding anything to the contrary in this Agreement, the Contemplated Transactions (including the Closing) shall not be delayed by or conditioned upon the consummation of the Approved Development Transaction.
6.23 Company Reverse Stock Split. Company shall submit to the Company Stockholders at the Company Stockholders Meeting a proposal to approve and adopt an amendment to the Companys Organizational Documents to authorize the board of directors of Company to effect the Company Reverse Stock Split and shall take such other actions as shall be reasonably necessary to effectuate the Company Reverse Stock Split.
6.24 Company Options and Company RSUs.
(a) Prior to the Closing, the board of directors of Company shall have adopted appropriate resolutions and taken all other actions necessary and appropriate to provide that each unexpired and unexercised Company Option, whether vested or unvested, shall be accelerated in full effective as of immediately prior to the Closing Date and, following such acceleration, each Company Option that has an exercise price greater than the then current trading price for shares of Company Common Stock (i.e., out-of-the-money options) shall expire on the Closing Date, to the extent not exercised prior to the Closing. Prior to the Closing Date, Company shall take all actions that may be necessary (under the Company Option Plan and otherwise) to effectuate the provisions of this Section 6.24(a).
(b) Prior to the Closing, the board of directors of Company shall have adopted appropriate resolutions and taken all other actions necessary and appropriate to provide that all performance and other conditions to the
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lapsing of restrictions on each outstanding Company RSU, whether vested or unvested, shall be deemed to be satisfied as of immediately prior to the Closing Date.
6.25 Stockholder Litigation. During the Pre-Closing Period, Company shall (a) advise F-Star in writing of any stockholder litigation against it or its directors relating to this Agreement or the Contemplated Transactions promptly after becoming aware of any such litigation and shall keep F-Star apprised regarding developments in such stockholder litigation and (b) give F-Star the opportunity to participate in the defense or settlement of any stockholder litigation relating to this Agreement or any of the Contemplated Transactions, and shall not settle any such litigation without F-Stars written consent, which consent shall not be unreasonably withheld, conditioned or delayed.
6.26 Termination of Contracts. Company shall use commercially reasonable efforts to (a) reasonably promptly after the date hereof terminate all Contracts listed on Schedule 6.26 and (b) fully satisfy, waive or otherwise discharge all obligations of Company and its Subsidiaries under such Contracts, in each case prior to Closing.
6.27 Company Lease Obligations. Company shall use reasonable efforts from and after the date hereof to assign or sublease the operating facility lease for the property located at 35 Parkwood Drive, Suite 210, Hopkinton, Massachusetts, 01748, on such terms as the Company may determine in its sole and absolute discretion.
6.28 F-Star Financials. No later than the date hereof, F-Star shall furnish to Company the F-Star Audited Financials and the F-Star Predecessor Audited Financials. F-Star will use commercially reasonable efforts to furnish to Company by August 17, 2020 the F-Star Unaudited Financials for the six-months ended June 30, 2019 and 2020. Thereafter, F-Star shall promptly provide Company with the F-Star Unaudited Financials for each subsequent interim period completed prior to Closing that would be required to be included in the Proxy Statement and the Registration Statement or any periodic report due prior to the Closing if F-Star were subject to the periodic reporting requirements under the Securities Act or the Exchange Act.
6.29 Articles of Association. From the Closing through the first (1st) anniversary of the Closing Date, Company shall not amend Article 28 of the Closing Articles of Association as in effect on the Closing Date.
6.30 Equity Commitment Exchange. Each of the Parties acknowledges and agrees that at any time prior to the Closing, an Investor or an Additional Investor party to an Equity Commitment Letter or Additional Equity Commitment Letter, as applicable, may elect to exchange all or a portion of such Persons Equity Commitment (as defined and set forth in such Persons Equity Commitment Letter or Additional Equity Commitment Letter, as applicable) (the amount that is the subject of such election, the Equity Commitment Exchange Amount) for a 2019 Loan Note issued by F-Star having a principal amount equal to such Persons Equity Commitment Exchange Amount (an Equity Commitment Exchange); provided, that, in no event shall the aggregate Equity Commitment Exchange Amount elected by all Investors and Additional Investors exceed $3,000,000.
6.31 F-Star Pre-Closing Financing. F-Star shall use its commercially reasonable efforts to consummate the F-Star Pre-Closing Financing for gross proceeds of not less than the Target Proceeds.
CONDITIONS TO THE CLOSING
7.1 Conditions to Obligation of Each Party to Effect the Acquisition. The respective obligations of each Party to effect the Acquisition will be subject to the satisfaction at or prior to the Closing of the following conditions:
(a) No Injunctions or Restraints; Illegality. No temporary restraining order, preliminary or permanent injunction or other order (whether temporary, preliminary or permanent) preventing the consummation of the Acquisition shall have been issued by any court of competent jurisdiction and remain in effect; and there will not be any statute, rule, regulation or order enacted, entered, enforced or deemed applicable to the Acquisition, which makes the consummation of the Acquisition illegal.
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(b) Stockholder Approval. The Company Stockholder Approval Matters will have been duly approved by the Company Stockholder Approval Threshold.
(c) Effective Registration Statement and Proxy Statement. The Registration Statement shall have become effective and no stop order suspending the effectiveness of the Registration Statement shall have been issued and no proceedings for that purpose shall have been initiated by the SEC and, prior to the conclusion of the Company Stockholders Meeting, (i) the SEC shall have issued no order suspending the use of the Proxy Statement, and (ii) no proceeding in respect of the Proxy Statement shall have been initiated by the SEC.
(d) Listing; Symbol. The shares of Company Common Stock to be issued in connection with the Acquisition shall be approved for listing on Nasdaq, subject to consummation of the Contemplated Transactions and official notice of issuance.
(e) Regulatory Approvals. All foreign antitrust approvals, to the extent applicable, shall have been obtained.
7.2 Additional Conditions to Obligations of F-Star and Sellers. The obligation of F-Star and Sellers to effect the Acquisition is also subject to the following conditions:
(a) Representations and Warranties. (i) The representations and warranties of Company contained in Sections 3.1(b) and 3.1(c) (Organization and Qualification; Charter Documents), Section 3.2 (Capital Structure) and Sections 3.3(a), 3.3(b), 3.3(c)(i) and 3.3(c)(ii) (Authority; Non-Contravention; Approvals) (other than, with respect to the representations and warranties contained in Section 3.2, inaccuracies that are de minimis, individually or in the aggregate) shall have been true and correct in all respects as of the date hereof and shall be true and correct in all respects on and as of the Closing with the same force and effect as if made on and as of such date (or, in the case of those representations and warranties that are made as of a particular date or period, as of such date or period), and (ii) the other representations and warranties of Company contained in this Agreement or in any certificate or other agreement delivered by Company pursuant hereto shall be true and correct at and as of the date hereof and as of the Closing with the same force and effect as if made on and as of such date (or, in the case of those representations and warranties that are made as of a particular date or period, as of such date or period), except, in the case of clause (ii), where the failure of such representations and warranties to be true and correct (disregarding all qualifications or limitations as to materially, Company Material Adverse Effect and words of similar import set forth therein) has not had, individually or in the aggregate, a Company Material Adverse Effect.
(b) Agreements and Covenants. Company will have performed or complied with in all material respects all agreements and covenants required by this Agreement to be performed or complied with by it on or prior to the Closing.
(c) Company Material Adverse Effect. Since the date hereof no Company Material Adverse Effect shall have occurred and be continuing.
(d) Other Deliveries. F-Star will have received certificates of good standing (or equivalent documentation) of Company in its jurisdiction of organization and each foreign jurisdiction in which it is qualified, a certified copy of Companys Certificate of Incorporation, a certificate as to the incumbency of directors and officers and the adoption of resolutions of the board of directors of Company approving this Agreement and the consummation of the Contemplated Transactions, and a certificate executed by a duly authorized officer of Company confirming that the conditions set forth in Sections 7.2(a), 7.2(b), 7.2(c), 7.2(d), 7.2(f), 7.2(g), 7.2(h) and 7.2(i) have been duly satisfied.
(e) Company Officers and Board of Directors. F-Star will have received a duly executed copy of a resignation letter from each of the resigning members of the board of directors of Company and the resigning officers of Company listed on Schedule VI, pursuant to which each such person will resign as a member of the board of directors of Company and as an officer of Company, as applicable, effective as of the Closing, and Companys board of directors will have adopted a resolution removing each officer of Company listed on Schedule VI from their respective positions as officers of Company effective as of the Closing. Company
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shall have caused the board of directors of Company to be constituted as set forth in Section 6.9 effective as of the Closing.
(f) Company Lock-up Agreements. The Company Lock-up Agreements shall be in full force and effect and shall continue to be in full force and effect immediately following the Closing.
(g) Suspension in Trading or Listing. No delisting or suspension in trading of Company Common Stock on Nasdaq shall have occurred and be continuing.
(h) Termination of Company Contracts. The Contracts set forth on Schedule 6.26 shall have been terminated, or, to the extent such Contracts have not been terminated as of the Closing, notice of termination shall have been given and any monetary Liabilities resulting from such termination shall have been accounted for in the calculation of Net Cash.
(i) Company Reverse Stock Split. Company shall have effected the Company Reverse Stock Split and provided F-Star with a file-stamped copy of the amendment to Companys Certificate of Incorporation effecting the Company Reverse Stock Split.
7.3 Additional Conditions to Obligations of Company. The obligation of Company to effect the Acquisition is also subject to the following conditions:
(a) Representations and Warranties. (i) The representations and warranties of F-Star contained in Sections 2.1(b) and 2.1(c) (Organization and Qualification; Charter Documents), Section 2.2 (Capital Structure), Sections 2.3(a), 2.3(b)(i), and 2.3(b)(ii) (Authority; Non-Contravention; Approvals), Section 2.11(f) (Employee Benefit Plans) and Section 2.22 (Ownership of Company Capital Stock) and the representations and warranties of Sellers contained in Sections 4.1 (Ownership of F-Star Share Capital and Loan Notes), and 4.2 (Authority; Non-Contravention) (other than, with respect to the representations and warranties contained in Sections 2.2 and 4.1, inaccuracies that are de minimis, individually or in the aggregate) shall have been true and correct in all respects at and as of the date hereof and shall be true and correct in all respects on and as of the Closing with the same force and effect as if made on and as of such date (or, in the case of those representations and warranties that are made as of a particular date or period, as of such date or period), and (ii) the other representations and warranties of F-Star and Sellers contained in this Agreement or in any certificate or other agreement delivered by F-Star or Sellers, as applicable, pursuant hereto shall have been true and correct in all respects at and as of the date hereof and shall be true and correct in all respects on and as of the Closing with the same force and effect as if made on and as of such date (or, in the case of those representations and warranties that are made as of a particular date or period, as of such date or period), except, in the case of clause (ii), where the failure of such representations and warranties to be true and correct (disregarding all qualifications or limitations as to materially, F-Star Material Adverse Effect and words of similar import set forth therein) has not had, individually or in the aggregate, an F-Star Material Adverse Effect.
(b) Agreements and Covenants. F-Star and Sellers will have performed or complied with in all material respects all agreements and covenants required by this Agreement to be performed or complied with by them on or prior to the Closing.
(c) F-Star Pre-Closing Financing. The F-Star Pre-Closing Financing shall have been consummated in accordance with the terms of the F-Star Pre-Closing Financing Agreements.
(d) F-Star Material Adverse Effect. Since the date hereof no F-Star Material Adverse Effect shall have occurred and be continuing.
(e) Other Deliveries.
(i) Company will have received: certificates of good standing (or equivalent documentation) of F-Star in its jurisdiction of organization and each foreign jurisdiction in which it is qualified, a certified copy of the Articles of Association; a certified copy of the register directors, certified copies of the resolutions of the board of directors of F-Star approving the Contemplated Transactions (as applicable), and a certificate executed by a duly authorized director of F-Star confirming that the conditions set forth in Sections 7.3(a), 7.3(b) and 7.3(d) have been duly satisfied.
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(ii) Sellers shall have delivered to the Exchange Agent duly executed transfers in favor of Company of all of the F-Star Shares and the duly executed powers of attorney or other authorities under which any of the transfers have been executed;
(iii) Sellers shall have delivered to the Exchange Agent the share certificates representing the F-Star Shares (or the indemnity for lost certificates pursuant to Section 1.9(b)); and
(iv) Sellers shall have delivered to the Exchange Agent or Company such waivers or consents as may be necessary to enable Company or its nominee(s) to become the registered holder of all of the F-Star Shares and such share certificates (or indemnities for lost share certificates) and stock transfer forms as may be required to give a good title to the F-Star Shares and to enable Company or its nominee(s), subject to stamping, to become the registered holders of them.
(f) Allocation Certificate. A duly authorized director of F-Star will have executed and delivered to Company the Allocation Certificate.
(g) Conversions. The Conversions shall have occurred.
(h) Seller Lock-up Agreements. The Seller Lock-up Agreements shall be in full force and effect and shall continue to be in full force and effect immediately following the Closing.
TERMINATION
8.1 Termination. This Agreement may be terminated and the Acquisition may be abandoned, at any time prior to the Closing, notwithstanding approval thereof by the Company Stockholders:
(a) by mutual written consent of Company and F-Star duly authorized by each of their respective boards of directors;
(b) by either F-Star or Company, after the End Date, if the Acquisition has not been consummated (provided that the right to terminate this Agreement under this Section 8.1(b) will not be available to any Party whose failure to fulfill any obligation under this Agreement has been the cause of or resulted in the failure of the Acquisition to occur on or before such date; provided, further, that the End Date shall be subject to extension to the extent required to permit compliance with the provisions of Section 1.5, including the final determination of Net Cash thereunder; and provided, further, that, in the event that the SEC has not declared effective under the Securities Act the Registration Statement by the date which is sixty (60) days prior to the End Date, each of Company and F-Star shall be entitled to extend the period for termination of this Agreement pursuant to this Section 8.1(b) for an additional sixty (60) days);
(c) by either F-Star or Company if a Governmental Body has issued a non-appealable final order, decree or ruling or taken any other action, in each case having the effect of permanently restraining, enjoining or otherwise prohibiting the Acquisition;
(d) by either F-Star or Company if (i) the Company Stockholders Meeting (including any adjournments and postponements thereof) shall have been held and completed and the Company Stockholders shall have taken a final vote on the Company Stock Issuance and Company Reverse Stock Split and (ii) the Company Stock Issuance or Company Reverse Stock Split shall not have been approved by the Company Stockholder Approval Threshold; provided, however, that the right to terminate this Agreement under this Section 8.1(d) shall not be available to a Party where the failure to obtain the Company Stockholder Approval shall have been caused by the action or failure to act of such Party and such action or failure to act constitutes a material breach by such Party of this Agreement;
(e) by F-Star upon breach of any of the representations, warranties, covenants or agreements on the part of Company set forth in this Agreement, or if any representation or warranty of Company will have become inaccurate, in either case such that the conditions set forth in Section 7.2(a) or Section 7.2(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty will have become inaccurate; provided if such breach or inaccuracy is curable by Company, then this Agreement will not terminate
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pursuant to this Section 8.1(e) as a result of such particular breach or inaccuracy unless the breach or inaccuracy remains uncured as of the thirtieth (30th) day following the date of written notice given by F-Star to Company of such breach or inaccuracy and its intention to terminate this Agreement pursuant to this Section 8.1(e); provided further that no termination may be made pursuant to this Section 8.1(e) solely as a result of the failure of Company to obtain the Company Stockholder Approval (in which case such termination must be made pursuant to Section 8.1(d));
(f) by Company upon breach of any of the representations, warranties, covenants or agreements on the part of F-Star or Sellers set forth in this Agreement, or if any representation or warranty of F-Star or Sellers will have become inaccurate, in either case such that the conditions set forth in Section 7.3(a) or Section 7.3(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty will have become inaccurate; provided if such breach or inaccuracy is curable by F-Star or Sellers, then this Agreement will not terminate pursuant to this Section 8.1(f) as a result of such particular breach or inaccuracy unless the breach or inaccuracy remains uncured as of the thirtieth (30th) day following the date of written notice given by Company to F-Star of such breach or inaccuracy and its intention to terminate this Agreement pursuant to this Section 8.1(f);
(g) by Company, if there will have occurred any F-Star Material Adverse Effect since the date hereof; provided, however, such termination shall only be effective if such F-Star Material Adverse Effect, if curable, is not cured within thirty (30) days following the date of written notice given by Company to F-Star of such F-Star Material Adverse Effect and its intention to terminate this Agreement pursuant to this Section 8.1(g);
(h) by F-Star, if there will have occurred any Company Material Adverse Effect since the date hereof; provided, however, such termination shall only be effective if such Company Material Adverse Effect, if curable, is not cured within thirty (30) days following the date of written notice given by F-Star to Company of the occurrence of such Company Material Adverse Effect and its intention to terminate this Agreement pursuant to this Section 8.1(h);
(i) by F-Star, prior to obtaining the Company Stockholder Approval, if (i) the board of directors of Company has failed to include the Company Board Recommendation in the Registration Statement or effected any Company Change in Recommendation; (ii) following the public disclosure of an Acquisition Proposal (other than a tender or exchange offer which is the subject of clause (v)), the board of directors of Company has failed to publicly reaffirm the Company Board Recommendation within five (5) Business Days after F-Star so requests in writing; (iii) Company has entered into any letter of intent or definitive agreement relating to any Acquisition Proposal (other than a confidentiality agreement permitted pursuant to Section 6.10(a)(i)); (iv) Company or any director or officer of Company shall have willfully and intentionally breached any provision set forth in Section 6.2 or Section 6.10(a)(i); or (v) the board of directors of Company has failed to recommend against, or taken a neutral position with respect to, a tender or exchange offer related to any Acquisition Proposal in any position taken pursuant to Rules 14d-9 and 14e-2 under the Exchange Act;
(j) by Company, prior to obtaining the Company Stockholder Approval, if (i) Company has received a Superior Offer, (ii) Company has complied in all material respects with its obligations under Section 6.2(c) in order to accept such Superior Offer, (iii) Company concurrently terminates this Agreement and enters into a definitive agreement with respect to such Superior Offer and (iv) Company pays to F-Star the Company Termination Fee in accordance with Section 8.3(b) no later than two (2) Business Days following such termination; or
(k) by Company, if the F-Star Pre-Closing Financing is terminated or does not occur prior to the End Date; provided, however, that the right to terminate this Agreement under this Section 8.1(k) shall not be available to Company where the failure to obtain the F-Star Pre-Closing Financing shall have been caused by the action or failure to act of Company and such action or failure to act constitutes a material breach by Company of this Agreement.
8.2 Effect of Termination. In the event of the termination of this Agreement pursuant to Section 8.1, this Agreement will forthwith become void and there will be no Liability on the part of any Party or any of its
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Affiliates, directors, officers or stockholders except (i) as set forth in Sections 8.2 and 8.3 and (ii) for any Liability for any knowing breach of any representation, warranty, covenant or obligation contained in this Agreement (for purposes of this Section 8.2 and Section 8.3(e), a knowing breach is an act or omission with the actual knowledge that such act or omission represents, or would cause, a breach of this Agreement). No termination of this Agreement will affect the obligations of the Parties contained in the Confidentiality Agreement, all of which obligations will, in addition to this Article 8 and in addition to Article 9, survive termination of this Agreement in accordance with its terms.
8.3 Expenses; Termination Fees.
(a) Except as set forth in this Section 8.3, all fees and expenses incurred in connection with this Agreement and the Contemplated Transactions will be paid by the Party incurring such expenses, whether or not the Acquisition is consummated. Notwithstanding the foregoing, (A) Company and F-Star shall share equally all fees and expenses, other than attorneys and accountants fees and expenses, incurred (i) in relation to the filings by the Parties under any filing requirement under any foreign antitrust Legal Requirement applicable to this Agreement and the Contemplated Transactions, (ii) by engagement of a proxy soliciting firm in connection with obtaining approval of the Company Stockholder Approval Matters, (iii) by engagement of the Exchange Agent and (iv) in relation to the printing (e.g., paid to a financial printer) and filing with the SEC of the Registration Statement (including any financial statements and exhibits) and any amendments or supplements thereto; provided, however, that in no event shall F-Star be obligated to bear any such costs and expenses in excess of $50,000, and (B) F-Star shall be solely responsible for all listing fees payable to Nasdaq in connection with the listing of the shares of Company Common Stock to be issued in connection with the Acquisition and reasonable out-of-pocket expenses of Company incurred in connection therewith. Each of the Parties acknowledges that the agreements contained in this Section 8.3 are an integral part of the Contemplated Transactions, without which, the Parties would not enter into this Agreement. It is understood and agreed that all fees and expenses incurred or to be incurred by Company in connection with the Contemplated Transactions and preparing, negotiating and entering into this Agreement and the performance of its obligations under this Agreement shall be paid by Company in cash at or prior to the Closing.
(b) Company will pay to F-Star a termination fee (the Company Termination Fee) in an amount in cash equal to $2,000,000, less any amounts previously paid pursuant to Section 8.3(c), in the event that this Agreement is terminated pursuant to (i) Section 8.1(b), (ii) Section 8.1(d), (iii) Section 8.1(e), (iv) Section 8.1(i) or (v) Section 8.1(j); provided that, in the case of each of clauses (i), (ii) and (iii), an Acquisition Proposal has been publicly announced, disclosed or otherwise communicated to Companys board of directors after the date hereof and prior to such termination and, within nine (9) months after the date of such termination, Company entered into a definitive agreement with respect to, or consummates, an Acquisition Transaction, such fee to be paid not later than two (2) Business Days after such entry into a definitive agreement or such Acquisition Transaction is consummated; provided that for purposes of this Section 8.3(b) all references in the definition of Acquisition Transaction to 20% shall instead refer to 50%. If this Agreement is terminated by F-Star pursuant to Section 8.1(i), then Company shall pay the Company Termination Fee to F-Star within two (2) Business Days following such termination.
(c) Company shall no later than two (2) Business Days after receipt of reasonable supporting documentation evidencing such fees and expenses reimburse F-Star and Sellers for all fees and expenses (up to $750,000) incurred by F-Star and Sellers in connection with the authorization, preparation, negotiation, execution and performance of this Agreement and the Contemplated Transactions if this Agreement is terminated by either party pursuant to Section 8.1(d).
(d) F-Star will pay to Company a termination fee (the F-Star Termination Fee) in an amount in cash equal to $2,000,000 in the event that this Agreement is terminated by Company pursuant to Section 8.1(k).
(e) In the event that F-Star shall be entitled to receive the Company Termination Fee or Company shall be entitled to receive the F-Star Termination Fee, such fee is not a penalty but shall be liquidated damages in a reasonable amount for any and all losses or damages suffered or incurred by F-Star and Sellers, on the one hand,
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Company, on the other hand, or in connection with the matter forming the basis for such termination. Notwithstanding any other provision of this Agreement to the contrary, other than as provided in this Section 8.3(e), the Parties agree that the payments contemplated by this Section 8.3 represent the sole and exclusive remedies of F-Star and Sellers, on the one hand, and Company, on the other hand, in respect of a termination pursuant to Section 8.1 under circumstances requiring the payment of the Company Termination Fee or the F-Star Termination Fee, as applicable; provided, that this Section 8.3(e) shall not apply where F-Stars right to terminate this Agreement pursuant to Section 8.1(d), 8.1(e) or 8.1(i) results from, or Company terminates this Agreement pursuant to Section 8.1(j) following, a knowing breach by Company of this Agreement.
(f) If Company or F-Star, as applicable, fails to pay when due any amount payable by Company or F-Star, as applicable, under this Section 8.3, then (i) Company or F-Star will, as applicable, reimburse F-Star and Sellers, on the one hand, and Company, on the other hand, for all costs and expenses (including fees and disbursements of counsel) incurred in connection with the collection of such overdue amount and the enforcement by the Parties of their rights under this Section 8.3, and (ii) Company or F-Star, as applicable, will pay to F-Star and Sellers, on the one hand, or Company, on the other hand, interest on such overdue amount (for the period commencing as of the date such overdue amount was originally required to be paid and ending on the date such overdue amount is actually paid to the Parties entitled thereto in full) at a rate per annum equal to the prime rate (as announced by Bank of America or any successor thereto) in effect on the date such overdue amount was originally required to be paid.
GENERAL PROVISIONS
9.1 Notices. Any notice or other communication required or permitted to be delivered to any Party under this Agreement will be in writing and will be deemed properly delivered, given and received: (a) if delivered by hand, when delivered; (b) if sent on a Business Day by email with confirmed receipt before 5:00 p.m. (recipients time) on the date sent, on such Business Day; (c) if sent by email on a day other than a Business Day, or if sent by email with confirmed receipt at any time after 5:00 p.m. (recipients time) on the date sent, on the date on which receipt is confirmed, if a Business Day, and otherwise on the first Business Day following the date on which receipt is confirmed; (d) if sent by registered, certified or first class mail, the third Business Day after being sent; and (e) if sent by overnight delivery via a national courier service, one Business Day after being sent, in each case to the address or email address set forth beneath the name of such Party below (or to such other address or email address as such Party shall have specified in a written notice given to the other Parties hereto):
(a) If to F-Star or Sellers:
F-Star Therapeutics Limited
Eddeva B920, Babraham Research Campus
Cambridge, CB22 3AT, UK
Attn: John Fitzpatrick
Email: john.fitzpatrick@f-star.com
With a copy (which shall not constitute notice) to:
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
One Financial Center
Boston, MA 02111
Attn.: William C. Hicks; Matthew W. Tikonoff
Email: WCHicks@mintz.com; MWTikonoff@mintz.com
(b) If to Company:
Spring Bank Pharmaceuticals, Inc.
35 Parkwood Dr., Suite 210
Hopkinton, MA 01748
Attn: Martin Driscoll; Garrett Winslow
Email: mdriscoll@springbankpharm.com;
gwinslow@springbankpharm.com
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With a copy (which shall not constitute notice) to:
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, NY 10020
Attn: John D. Hogoboom
Email: jhogoboom@lowenstein.com
9.2 Amendment. This Agreement may be amended by action taken in writing by or on behalf of the respective boards of directors of Company and F-Star; provided that no representation, warranty or covenant in this Agreement with respect to a Seller may be amended in a manner adverse to a Seller unless such amendment applies to all Sellers in the same fashion and the Parties obtain the prior written approval of such amendment from the Seller Majority; provided further that any amendment or waiver of the provisions of Section 6.5 after the Closing which adversely affects the D&O Indemnified Parties must be approved in writing by the D&O Indemnified Parties; and provided further that, after approval of the Acquisition by the Company Stockholder Approval no amendment may be made which by Legal Requirements requires further approval by such stockholders without such further approval.
9.3 Headings. The headings contained in this Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this Agreement.
9.4 Severability. If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any rule of law, or public policy, all other conditions and provisions of this Agreement will nevertheless remain in full force and effect so long as the economic or legal substance of the Contemplated Transactions is not affected in any manner adverse to any Party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the Parties will negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner to the end that the Contemplated Transactions are fulfilled to the extent possible.
9.5 Entire Agreement. This Agreement and the CVR Agreements constitute the entire agreement and supersede all prior agreements and undertakings (other than the Confidentiality Agreement), both written and oral, among the Parties, or any of them, with respect to the subject matter hereof.
9.6 Successors and Assigns. This Agreement will be binding upon: (a) Company and its successors and assigns (if any); (b) F-Star and its successors and assigns (if any); and (c) Sellers and their respective heirs, successors and assigns (if any). This Agreement will inure to the benefit of: (i) Company; (ii) F-Star; (iii) Sellers; and (iv) the respective heirs, successors and assigns (if any) of the foregoing. Neither Company nor F-Star may assign this Agreement or any of its rights, interests or obligations hereunder without the prior written approval of both the other and a Seller Majority, and no Seller may assign this Agreement or any of its rights, interests or obligations hereunder without the prior written approval of Company, F-Star and a Seller Majority (calculated by disregarding the shares in the F-Star Share Capital held by the assigning Seller). Any purported assignment in violation of this Section 9.6 shall be null and void ab initio.
9.7 Parties in Interest. This Agreement will be binding upon and inure solely to the benefit of each Party, and nothing in this Agreement, expressed or implied, is intended to or will confer upon any other Person any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement, other than Section 6.5 (which is intended to be for the benefit of D&O Indemnified Parties and may be enforced by D&O Indemnified Parties). Notwithstanding the foregoing, for the avoidance of doubt, Company shall have the right to enforce this Agreement directly against any Seller in the event of a breach by such Seller of this Agreement.
9.8 Waiver. No failure or delay on the part of any Party in the exercise of any right hereunder will impair such right or be construed to be a waiver of, or acquiescence in, any breach of any representation, warranty or agreement herein, nor will any single or partial exercise of any such right preclude other or further exercise thereof or of any other right. At any time prior to the Closing, any Party may, with respect to any other Party, (a) extend the time for the performance of any of the obligations or other acts, (b) waive any inaccuracies in the representations and warranties contained herein or in any document delivered pursuant hereto and (c) waive
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compliance with any of the agreements or conditions contained herein. Any such extension or waiver will be valid if set forth in an instrument in writing signed by the Party or Parties to be bound.
9.9 Remedies Cumulative; Specific Performance. Except for the matters described in Section 8.3(e) as exclusive remedies, all rights and remedies existing under this Agreement are cumulative to, and not exclusive of, any rights or remedies otherwise available. Each Party agrees that, in the event of any breach or threatened breach by another Party of any covenant, obligation or other provision set forth in this Agreement: (a) such first Party will be entitled, without any proof of actual damages (and in addition to any other remedy that may be available to it) to: (i) a decree or order of specific performance or mandamus to enforce the observance and performance of such covenant, obligation or other provision; and (ii) an injunction restraining such breach or threatened breach; and (b) such first Party will not be required to provide any bond or other security in connection with any such decree, order or injunction or in connection with any related action or Legal Proceeding.
9.10 Governing Law; Venue; Waiver of Jury Trial.
(a) This Agreement will be governed by, and construed in accordance with, the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws thereof.
(b) The Parties hereto agree that any Legal Proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the Contemplated Transactions shall be brought in the Chancery Court of the State of Delaware located in Wilmington, Delaware and any state appellate court therefrom located in Wilmington, Delaware, or, if no such state court has proper jurisdiction, the Federal District Court for the District of Delaware located in Wilmington, Delaware, and any appellate court therefrom. Each Party hereto hereby irrevocably submits to the exclusive jurisdiction of such court in respect of any legal or equitable Legal Proceeding arising out of or relating to this Agreement or the Contemplated Transactions, or relating to enforcement of any of the terms of this Agreement, and hereby waives, and agrees not to assert, as a defense in any such Legal Proceeding, any claim that it is not subject personally to the jurisdiction of such court, that the Legal Proceeding is brought in an inconvenient forum, that the venue of the Legal Proceeding is improper or that this Agreement or the Contemplated Transactions may not be enforced in or by such courts. Each Party hereto agrees that notice or the service of process in any Legal Proceeding arising out of or relating to this Agreement or the Contemplated Transactions shall be properly served or delivered if delivered in the manner contemplated by Section 9.1 or in any other manner permitted by applicable Legal Requirement.
(c) EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES, TO THE EXTENT PERMITTED BY APPLICABLE LEGAL REQUIREMENTS, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, SUIT OR OTHER LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE CONTEMPLATED TRANSACTIONS.
9.11 Counterparts and Exchanges by Electronic Transmission or Facsimile. This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts and by facsimile or electronic (i.e., PDF) transmission, each of which when executed will be deemed to be an original but all of which taken together will constitute one and the same agreement.
9.12 Attorney Fees. In any action at law or suit in equity to enforce this Agreement or the rights of any of the Parties hereunder, the prevailing party in such action or suit will be entitled to receive a reasonable sum for its attorneys fees and all other reasonable costs and expenses incurred in such action or suit upon the judgment in such action or suit becoming final and nonappealable.
9.13 Cooperation. Each Party agrees to cooperate fully with the other Parties hereto and to execute and deliver such further documents, certificates, agreements and instruments and to take such other actions as may be reasonably requested by the other Parties hereto to evidence or reflect the Contemplated Transactions and to carry out the intent and purposes of this Agreement and the Contemplated Transactions.
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9.14 Limited Survival of Representations and Warranties. The representations and warranties of F-Star, Sellers and Company contained in this Agreement or any certificate or instrument delivered pursuant to this Agreement shall terminate at the Closing.
(a) For purposes of this Agreement, whenever the context requires: the singular number will include the plural, and vice versa; the masculine gender will include the feminine and neuter genders; the feminine gender will include the masculine and neuter genders; and the neuter gender will include masculine and feminine genders.
(b) The Parties agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party will not be applied in the construction or interpretation of this Agreement.
(c) As used in this Agreement, the words include and including, and variations thereof, will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words without limitation.
(d) Except as otherwise indicated, all references in this Agreement to Sections, Exhibits and Schedules are intended to refer to Sections of this Agreement and Exhibits or Schedules to this Agreement.
(e) The term knowledge of Company, and all variations thereof, will mean the actual knowledge of the Company Persons, or any of them, after reasonable inquiry. The term knowledge of F-Star, and all variations thereof, will mean the actual knowledge of the F-Star Persons, or any of them, after reasonable inquiry.
(f) Unless otherwise specified, all calculations performed pursuant to the terms of this Agreement shall be calculated to four decimal places (0.0001).
(g) For purposes of this Agreement, information provided to, made available to , supplied to or to be supplied to hereunder shall be deemed to include any information made available by Company to F-Star or by F-Star to Company, as applicable, in the virtual dataroom(s) of Company or F-Star, as applicable, prior to the date of this Agreement.
[Signature Page Follows]
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IN WITNESS WHEREOF, the undersigned have caused this Share Exchange Agreement to be executed as of the date first written above.
F-STAR THERAPEUTICS LIMITED | ||
By: |
/s/ Eliot Forster, Ph.D. |
|
Name: Eliot Forster, Ph.D. | ||
Title: President and Chief Executive Officer | ||
SPRING BANK PHARMACEUTICALS, INC. | ||
By: |
/s/ Martin Driscoll |
|
Name: Martin Driscoll | ||
Title: President and Chief Executive Officer | ||
SELLERS | ||
ATLAS VENTURE FUND VII, L.P. | ||
By: |
Atlas Venture Associates VII, L.P. |
|
Its general partner | ||
By: |
Atlas Venture Associates VII, Inc. |
|
Its general partner | ||
By: |
/s/ Travis MacInnes |
|
Name: Travis MacInnes | ||
Title: Authorised Signatory | ||
ATLAS VENTURE OPPORTUNITY FUND I, L.P. | ||
By: |
Atlas Venture Associates Opportunity I, L.P. |
|
Its general partner | ||
By: |
Atlas Venture Associates Opportunity I, LLC |
|
Its general partner | ||
By: |
/s/ Ommer Chohan |
|
Name: Ommer Chohan | ||
Title: Authorised Signatory |
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COOPERATIEVE AESCAP VENTURE I U.A. | ||
By: AESCAP VENTURE MANAGEMENT B.V. | ||
Its acting manager | ||
By: |
/s/ Patrick Krol |
|
Name: Patrick Krol | ||
Title: Authorised Signatory | ||
By: |
/s/ Hans Bosman |
|
Name: Hans Bosman | ||
Title: Authorised Signatory | ||
TVM LIFE SCIENCE VENTURES VI GMBH & CO. KG, Munich | ||
By: | TVM CAPITAL GMBH | |
Its general partner and liquidator | ||
By: |
/s/ Stefan Fischer |
|
Name: Stefan Fischer | ||
Title: Authorised Signatory | ||
By: |
/s/ Josef Moosholzer |
|
Name: Josef Moosholzer | ||
Title: Authorised Signatory |
TVM LIFE SCIENCE VENTURES VI LIMITED PARTNERSHIP, Cayman Islands | ||
By: | TVM LIFE SCIENCE VENTURES VI CAYMAN LIMITED | |
Its general partner | ||
By: |
/s/ Stefan Fischer |
|
Name: Stefan Fischer | ||
Title: Authorised Signatory | ||
By: |
/s/ Josef Moosholzer |
|
Name: Josef Moosholzer | ||
Title: Authorised Signatory |
MP HEALTHCARE VENTURE MANAGEMENT, INC. | ||
By: |
/s/ Jeffrey Moore |
|
Name: Jeffrey Moore | ||
Title: Authorised Signatory | ||
MERCK VENTURES BV | ||
By: |
/s/ Jasper Bos |
|
Name: Jasper Bos | ||
Title: Authorised Signatory | ||
By: |
/s/ Hakan Goker |
|
Name: Hakan Goker | ||
Title: Authorised Signatory | ||
S.R. ONE, LIMITED | ||
By: |
/s/ Karen Narolewski Engel |
|
Name: Karen Narolewski Engel | ||
Title: Vice President |
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NOVO HOLDINGS A/S | ||
By: |
/s/ John P. Fitzpatrick |
|
Name: John P. Fitzpatrick | ||
Title: Acting Attorney | ||
JSH BIOTECH APS | ||
By: |
/s/ John Haurum |
|
Name: John Haurum | ||
Title: Authorised Signatory | ||
ARK INVEST APS | ||
By: |
/s/ John Haurum |
|
Name: John Haurum | ||
Title: Authorised Signatory | ||
/s/ John Haurum |
||
John Haurum | ||
/s/ Eliot Forster |
||
Eliot Forster |
||
/s/ Jonathan Milner |
||
Jonathan Milner |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Michael John Davies |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Jacqueline Doody |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Gordana Wozniak-Knopp |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Mihriban Tuna |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Florian Ruker |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Jane Dancer |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Haijun Sun |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Tolga Hassan |
||
/s/ John P. Fitzpatrick, power of attorney |
||
Neil Brewis | ||
/s/ John P. Fitzpatrick, power of attorney |
||
John Edwards | ||
/s/ John P. Fitzpatrick, power of attorney |
||
Kathleen Courtemanche |
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THE FOLLOWING EXHIBITS AND SCHEDULES TO THE SHARE EXCHANGE AGREEMENT HAVE BEEN OMITTED IN ACCORDANCE WITH ITEM 601(B)(2) OF REGULATION S-K.
Exhibits | ||
Exhibit F | Form of Deed of Termination Shareholders Agreement | |
Exhibit H: | Sample Net Cash Calculation | |
Exhibit J: | Sample Exchange Ratio Calculation | |
Schedules: | ||
Schedule I | Sellers | |
Schedule II | Company Lock-up Agreement Parties | |
Schedule III-A | Seller Lock-up Agreement Parties | |
Schedule III-B | Additional Seller Lock-up Agreement Parties | |
Schedule IV | Company Voting Agreement Parties | |
Schedule V | F-Star Pre-Closing Financing Subscription Amounts | |
Schedule VI | Company Director and Officer Resignations | |
Schedule 5.1 | Conduct of Company Business | |
Schedule 5.1(t) | Vendors | |
Schedule 6.9 | Director and Officer Appointees | |
Schedule 6.26 | Termination of Contracts |
Part 2.7 Intellectual Property |
Part 2.9(a) Legal Proceedings; Orders |
Part 2.10 Brokers and Finders Fees |
Part 2.11 Employee Benefit Plans |
Part 2.12 Title to Assets; Real Property |
Part 2.15 F-Star Contracts |
Part 2.17(b) Insurance |
Part 2.19 Interested Party Transactions |
Part 4.1 Ownership of F-Star Issued Share Capital and Loan Notes |
Part 4.5 Ownership of Company Capital Stock |
Company Disclosure Schedule |
Part 3.1(a) Organization and Qualification |
Part 3.2(b) Company Options and Company RSU |
Part 3.2(c) Company Warrants |
Part 3.2(d) Restrictive Rights |
Part 3.3(c) Non-Contravention |
Part 3.5(e) Undisclosed Liabilities |
Part 3.6 Absence of Certain Changes or Events |
Part 3.7(d) Tax Matters |
Part 3.8 Intellectual Property |
Part 3.9 Compliance with Legal Requirements |
Part 3.10(a) Legal Proceedings; Orders |
Part 3.11 Brokers and Finders Fees |
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Part 3.12 Employee Benefit Plans |
Part 3.13 Title to Assets; Real Property |
Part 3.15(a) Labor Matters |
Part 3.16 Material Contracts |
Part 3.18 Insurance |
Part 3.23 Interested Party Transactions |
Part 3.24 Bank Accounts; Deposits |
Spring Bank Pharmaceuticals, Inc. will furnish supplementally a copy of any omitted schedule to the Securities and Exchange Commission upon request, provided however that Spring Bank Pharmaceuticals, Inc. may request confidential treatment pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended for any schedule so furnished as such exhibits are both not material and would likely cause competitive harm to the registrant if publicly disclosed.
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EXHIBIT A
CERTAIN DEFINITIONS
For purposes of this Agreement (including this Exhibit A):
Acquiring Companies means Company and its Subsidiaries.
Acquisition Proposal means any offer, proposal, inquiry or indication of interest contemplating or otherwise relating to any Acquisition Transaction.
Acquisition Transaction means any transaction or series of transactions involving:
(a) any merger, consolidation, amalgamation, share exchange, business combination, issuance of securities, acquisition of securities, tender offer, exchange offer or other similar transaction (i) in which Company (or its Subsidiaries) is a constituent corporation, (ii) in which a Person or group (as defined in the Exchange Act and the rules promulgated thereunder) of Persons directly or indirectly acquires beneficial or record ownership of securities representing more than twenty percent (20%) of the outstanding securities of any class of voting securities of Company (or its Subsidiaries), or (iii) in which Company (or its Subsidiaries) issues securities representing more than twenty percent (20%) of the outstanding securities of any class of voting securities of any such Entity (other than as contemplated under this Agreement);
(b) any sale, lease, exchange, transfer, license, acquisition or disposition of any business or businesses or assets that constitute or account for twenty percent (20%) or more of the consolidated net revenues, net income or assets of Company (or its Subsidiaries); or
(c) any liquidation or dissolution of any of Company (or its Subsidiaries).
For the avoidance of doubt, no Permitted Disposition shall be deemed to be an Acquisition Transaction.
Affiliates means, with respect to any Person, any other Person which directly or indirectly controls, is controlled by or is under common control with such first Person.
Approved Development Agreement means a definitive agreement entered into by Company for the Approved Development Transaction, including all exhibits, schedules and related agreements thereto.
Approved Development Transaction means the proposed transaction relating to Companys STimulator of INterferon Genes (STING) antagonist program contemplated by the Term Sheet.
Articles of Association means the articles of association of F-Star as amended and in effect from time to time prior to Closing.
Business Day means a day other than a Saturday, Sunday or other day on which commercial banks located in Boston, Massachusetts or London, England are authorized or required by applicable Legal Requirements to close; provided, however, for clarification, commercial banks shall not be deemed to be authorized or required by applicable Legal Requirements to close due to stay at home, shelter-in-place, non-essential employee or any other similar orders or restrictions or the closure of any physical branch locations at the direction of any Governmental Body so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in such location generally are open for use by customers on such day.
Closing Articles of Association means the amended articles of association of F-Star substantially in the form attached hereto as Exhibit I to be adopted on or after Closing.
Code shall mean the Internal Revenue Code of 1986, as amended, and the Treasury Regulations promulgated thereunder.
Company 2016 Warrants means the warrants to purchase 1,633,777 shares of Company Common Stock issued by Company on November 23, 2016.
Company Common Stock means the Common Stock of Company, par value $0.0001.
Company Disclosure Schedule means the disclosure schedule that has been delivered by Company to F-Star as of the date hereof.
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Company IP Rights means all IP Rights in which an Acquiring Company has any right, title or interest or which are used or held for use by an Acquiring Company.
Company Material Adverse Effect means any Effect that, considered together with all other Effects, has, or is reasonably expected to have, a material adverse effect on: (a) the business, financial condition, operations or results of operations of the Acquiring Companies taken as a whole; provided, however, that in no event shall any of the following, alone or in combination, be deemed to constitute, nor shall any of the following be taken into account in determining whether there has occurred, a Company Material Adverse Effect: Effects resulting from (i) conditions generally affecting the industries in which the Acquiring Companies participate or the United States or global economy or capital markets as a whole, to the extent that such conditions do not have a disproportionate impact on the Acquiring Companies, taken as a whole, relative to other companies in the industry in which the Acquiring Companies operate; (ii) changes in the trading price or trading volume of Company Common Stock (it being understood, however, that any Effect causing or contributing to such changes in the trading price or trading volume of Company Common Stock may constitute a Company Material Adverse Effect and may be taken into account in determining whether a Company Material Adverse Effect has occurred); (iii) any failure by Company to meet any Company estimates or expectations of Companys development programs, any internal or analyst projections or forecasts or third party revenue or earnings predictions for any period ending (or for which revenues or earnings are released) on or after the date hereof (it being understood, however, that any Effect causing or contributing to such failures to meet projections or forecasts may constitute a Company Material Adverse Effect and may be taken into account in determining whether a Company Material Adverse Effect has occurred); (iv) the execution, delivery, announcement or performance of the obligations under this Agreement or the announcement, pendency or anticipated consummation of the Contemplated Transactions; (v) any natural disaster or any acts of terrorism, sabotage, military action or war or any escalation or worsening thereof, or any viruses, pandemics, epidemic or other outbreak of illness or public health event, or any spread or worsening thereof, or any other Effect that may be considered a force majeure event; (vi) any changes (after the date hereof) in GAAP or applicable Legal Requirements (or, in each case, the interpretation thereof) to the extent that such conditions do not have a disproportionate impact on the Acquiring Companies, taken as a whole, relative to other companies in the industry in which the Acquiring Companies operate; (vii) general conditions in financial markets, and any changes therein (including any changes arising out of acts of terrorism, war, weather conditions or other force majeure event), to the extent that such conditions and changes do not have a disproportionate impact on the Acquiring Companies, taken as a whole, relative to other companies in the industry in which the Acquiring Companies operate or to which other companies undertaking transactions similar to the Contemplated Transactions may be subject; (viii) the taking of any action, or the failure to take any action, by any Acquiring Company, that is required or reasonably necessary to comply with the terms of this Agreement or the taking of any action permitted by Part 5.1 of the Company Disclosure Schedule; (ix) any changes in or affecting research and development, clinical trials or other drug development activities (including the failure to obtain positive results from clinical trials, the occurrence of adverse events or serious adverse events in any clinical trial, development activities or favorable responses from any applicable Governmental Body) conducted by or on behalf of an Acquiring Company or licensees in respect of Companys products or product candidates (it being understood, however, that any effect of any such adverse event or serious adverse event in any clinical trial (taking into account the intended patient population and phase of dose escalation of such clinical trial) on any Acquiring Company may be taken into account in determining whether a Company Material Adverse Effect has occurred); (x) any rejection or non-acceptance by a Governmental Body of a registration or filing by any Acquiring Company relating to any IP Rights of the Acquiring Companies; (xi) regulatory approval of, or regulatory action or announcement with respect to, any product, or product candidates, of a third party that are similar to, or expected to compete against, any of Companys product candidates; or (xii) any stockholder or derivative litigation arising from or relating to this Agreement or the Contemplated Transactions; or (b) the ability of Company to consummate the Acquisition or to perform any of its covenants or obligations under this Agreement.
Company $1.41 Options means the Company Options to purchase an aggregate of 198,000 shares of Company Common Stock having a per-share exercise price of $1.41 granted by Company on March 5, 2020.
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Company Option means an option to purchase shares of Company Common Stock granted under the Company Option Plan.
Company Option Plan means, collectively, the 2014 Stock Incentive Plan and the Amended and Restated 2015 Stock Incentive Plan.
Company Owned IP Rights shall mean all Company Registered IP Rights owned by any Acquiring Company and all other IP Rights owned by any Acquiring Company that were developed by an Acquiring Company or were developed by a third party and subsequently assigned to any Acquiring Company.
Company Persons means Martin Driscoll, Lori Firmani and Garrett Winslow.
Company Reverse Stock Split means a reverse stock split of all outstanding shares of Company Common Stock at a reverse stock split ratio to be mutually agreed to by Company and F-Star.
Company RSU means a stock unit granted under the Company Option Plan that entitles the holder thereof to a share of Company Common Stock or value based on a share of Company Common Stock upon vesting or settlement of such unit, either as a result of time or performance metrics.
Company Stockholder Approval Matters means the approval of the issuance of the Acquisition Consideration (the Company Stock Issuance), an amendment to Companys Certificate of Incorporation to effect the Company Reverse Stock Split and change the name of Company to F-Star Therapeutics, Inc., and any amendments to, or adoption of, any option or warrant plans to give effect to the Contemplated Transactions.
Company Stockholder Approval Threshold means (i) with respect to the approval of the amendment to the Companys Organizational Documents to effect the Company Reverse Stock Split, the affirmative vote of a majority of the voting power of the capital stock of Company entitled to vote thereon, voting as a single class, and (ii) with respect to each other Company Stockholder Approval Matter, the affirmative vote of a majority of the outstanding shares of Company Common Stock held by the Company Stockholders present or represented by proxy and voting affirmatively or negatively on such Company Stockholder Approval Matter.
Company Stockholders means the holders of the issued and outstanding shares of Company Common Stock.
Company $2.08 Warrants means the Company Warrants to purchase an aggregate of 250,000 shares of Company Common Stock having a per-share exercise price of $2.08 issued by Company on September 18, 2019, as amended and restated on April 8, 2020.
Company Warrant means the outstanding warrants to purchase shares of Company Common Stock set forth in Part 3.2(c) of the Company Disclosure Schedule.
Consent means any approval, consent, ratification, permission, waiver or authorization.
Contemplated Transactions means the Acquisition, the Conversions, the Company Reverse Stock Split, the issuance to the holders of Company Common Stock immediately prior to the Closing of the right to receive contingent cash payments pursuant to the CVR Agreements and the other transactions and actions contemplated by this Agreement.
Contract means any written or oral agreement, contract, subcontract, lease, understanding, arrangement, instrument, note, option, warranty, purchase order, license, sublicense, insurance policy or legally binding commitment or undertaking of any nature.
Conversions means the 2019 Loan Note Conversion and the Share Conversion.
Copyrights means all copyrights and copyrightable works (whether or not registered, and including without limitation databases and other compilations of information) that may exist or be created under the laws of any jurisdiction, including all rights in works of authorship, use, publication, reproduction, distribution, public performance, public display, in the creation of derivative works, sound recordings, transformation, moral rights and rights of ownership of copyrightable works and all registrations and rights to register and obtain renewals and extensions of registrations.
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Effect means any event, development, circumstance, change, effect or occurrence.
Employment Legislation means (i) legislation applying in England and Wales directly or indirectly affecting the relations (whether contractual or otherwise) between the F-Star Companies and the F-Star Personnel (whether individually or collectively) including the provisions of any EU treaty or Directive directly enforceable by any F-Star Personnel against any F-Star Company, (ii) any legislation applying in England and Wales relating to any F-Star Personnels right to work in the United Kingdom, and (iii) other equivalent Legal Requirement in the United States.
Encumbrance means any lien, pledge, hypothecation, charge, mortgage, easement, encroachment, imperfection of title, title exception, title defect, right of possession, lease, tenancy license, security interest, encumbrance, claim, infringement, interference, preemptive right, community property interest or restriction of any nature (including any restriction on the voting of any security, any restriction on the transfer of any security or other asset, any restriction on the receipt of any income derived from any asset, any restriction on the use of any asset and any restriction on the possession, exercise or transfer of any other attribute of ownership of any asset). For the avoidance of doubt, Encumbrance does not include Out Licenses.
End Date means January 29, 2021.
Entity means any corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any company limited by shares, limited liability company or joint stock company), firm, society or other enterprise, association, organization or entity.
Environmental Law means any federal, state, local or foreign Legal Requirement relating to pollution or protection of human health or the environment (including ambient air, surface water, ground water, land surface or subsurface strata), including any law or regulation relating to emissions, discharges, releases or threatened releases of Hazardous Materials, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials.
Equity Commitment Letter means the Equity Commitment Letters by and among F-Star and the Persons named therein, entered into on or prior to the date hereof, pursuant to which such Persons have agreed to enter into the Subscription Agreement and to purchase pursuant to the Subscription Agreement the number of F-Star Ordinary Shares set forth therein in connection with the F-Star Pre-Closing Financing.
ERISA Affiliate means, with respect to an entity, a trade or business (whether or not incorporated) that is, or at any relevant time was treated as a single employer of such entity within the meaning of Section 414(b) or 414(c) of the Code.
Exchange Ratio means, subject to Section 1.4(c), the following ratio (rounded to four decimal places): the quotient obtained by dividing (a) the F-Star Transaction Shares by (b) the F-Star Outstanding Shares, in which:
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Aggregate Valuation means the sum of (a) the Company Valuation, plus (b) the F-Star Post-Financing Valuation. |
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Company Allocation Percentage means the quotient (rounded to two decimal places) determined by dividing (i) the Company Valuation by (ii) the Aggregate Valuation. |
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Company Outstanding Shares means, subject to Section 1.4(c), the total number of shares of Company Common Stock outstanding immediately prior to the Closing expressed on a fully-diluted basis and calculated using the treasury stock method, assuming, without limitation or duplication, (a) the exercise of each Company Option outstanding and unexercised immediately prior to the Closing that has an exercise price less than or equal to the then current trading price for shares of Company Common Stock (i.e., in-the-money options), excluding any portion thereof which cannot become vested or exercisable or will otherwise not be outstanding immediately after the Closing; and (b) the exercise of each Company Warrant outstanding and unexercised immediately prior to the Closing that has an exercise price less than or equal to the then current trading price for shares of Company Common Stock (i.e., in-the-money warrants) and will be outstanding immediately after the |
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Closing; provided, however, that (i) the Company $1.41 Options shall be included in the calculation of Company Outstanding Shares and (ii) the Company $2.08 Warrants shall be excluded from the calculation of Company Outstanding Shares. For the avoidance of doubt, except as expressly provided above, shares of Company Common Stock issuable upon the exercise of Company Options or Company Warrants that are not in-the-money immediately prior to the Closing will be excluded from the calculation of Company Outstanding Shares. |
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Company Valuation means $38,000,000; provided, however, to the extent that (a) Net Cash determined pursuant to Section 1.5 is less than Fifteen Million Dollars ($15,000,000) (such amount, as may be adjusted pursuant to the following proviso, the Adjustment Threshold), then the Company Valuation shall be reduced by one dollar for each dollar that Net Cash is below the Adjustment Threshold (for example, the Company Valuation would be $37,000,000 if Net Cash determined pursuant to Section 1.5 is $14,000,000), and (b) Net Cash determined pursuant to Section 1.5 is more than Seventeen Million Dollars ($17,000,000) (such amount, as may be adjusted pursuant to the following proviso, the Upward Adjustment Threshold), then the Company Valuation shall be increased by one dollar for each dollar that Net Cash is above the Upward Adjustment Threshold (for example, the Company Valuation would be $39,000,000 if Net Cash determined pursuant to Section 1.5 is $18,000,000); provided that if the Closing shall not have occurred on or prior to October 30, 2020, then the Adjustment Threshold and the Upward Adjustment Threshold shall automatically decrease by $250,000 on such date and shall further decrease by the same amount on the last day of each thirty (30)-day period occurring thereafter until the Closing. |
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F-Star Allocation Percentage means the quotient (rounded to two decimal places) determined by dividing (i) the F-Star Post-Financing Valuation by (ii) the Aggregate Valuation. |
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F-Star Outstanding Shares means, subject to Section 1.4(c), the total number of F-Star Ordinary Shares outstanding immediately prior to the Closing expressed on a fully-diluted basis and calculated using the treasury stock method, assuming, without limitation or duplication, (i) the Conversions, (ii) the exercise of all F-Star Options outstanding as of immediately prior to the Closing, (iii) the issuance of F-Star Ordinary Shares upon the vesting of all F-Star RSUs outstanding as of immediately prior to the Closing, (iv) the consummation of the F-Star Pre-Closing Financing and the issuance of F-Star Ordinary Shares pursuant to the F-Star Pre-Closing Financing Agreements (including the conversion of any 2019 Loan Notes issued in respect of any Equity Commitment Exchange), and (v) the issuance of F-Star Ordinary Shares in respect of all other options, warrants or rights to receive F-Star Ordinary Shares that will be outstanding immediately prior to the Closing. |
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F-Star Post-Financing Valuation means the sum of (i) the F-Star Pre-Money Valuation minus (ii) the F-Star Valuation Adjustment, if any, plus (iii) the F-Star Pre-Closing Financing Proceeds. |
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F-Star Pre-Closing Financing Proceeds means the aggregate amount of proceeds actually received by F-Star in the F-Star Pre-Closing Financing. |
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F-Star Pre-Money Valuation means the lesser of (i) $35,000,000 or (ii) the pre-money valuation attributed to F-Star in the F-Star Pre-Closing Financing. |
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F-Star Transaction Shares means the product (rounded to two decimal places) determined by multiplying (i) the Post-Closing Company Shares by (ii) the F-Star Allocation Percentage. |
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F-Star Valuation Adjustment means the amount, if any, by which the Target Proceeds exceeds the Subscribed Proceeds as of the Measurement Time. |
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Post-Closing Company Shares mean the quotient (rounded to two decimal places) determined by dividing (i) the Company Outstanding Shares by (ii) the Company Allocation Percentage. |
For the avoidance of doubt and for illustrative purposes only, a sample Exchange Ratio calculation is attached hereto as Exhibit J.
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F-Star Acquisition Proposal means, subject to the proviso below, any offer, proposal, inquiry or indication of interest contemplating or otherwise relating to any transaction or series of transactions involving:
(a)any merger, consolidation, amalgamation, share exchange, business combination, acquisition of securities, tender offer, exchange offer or other similar transaction (i) in which F-Star (or any of its Subsidiaries) is a constituent corporation, (ii) in which a Person or group (as defined in the Exchange Act and the rules promulgated thereunder) of Persons directly or indirectly acquires beneficial or record ownership of securities representing more than twenty percent (20%) of the outstanding securities of any class of voting securities of F-Star (or any of its Subsidiaries), or (iii) in which F-Star (or any of its Subsidiaries) issues securities representing more than twenty percent (20%) of the outstanding securities of any class of voting securities of any such Entity (other than as contemplated under this Agreement); or
(b)any sale, lease, exchange, transfer, acquisition or disposition of any business or businesses or assets that constitute or account for twenty percent (20%) or more of the consolidated net revenues, net income or assets of F-Star (or its Subsidiaries);
provided that, notwithstanding the foregoing, in no event shall (i) the issuance or potential issuance of securities by an F-Star Company representing less than fifty percent (50%) of the outstanding voting securities of F-Star (or any of its Subsidiaries), on an as-converted basis, in the F-Star Pre-Closing Financing, or (ii) any license, collaboration or joint venture, or any transfer or disposition of assets in connection therewith, entered into or contemplated for bona fide business development purposes, be or constitute an F-Star Acquisition Proposal.
F-Star Companies means F-Star and its Subsidiaries.
F-Star Data Room means the electronic documentation site hosted by Datasite on behalf of F-Star.
F-Star Disclosure Schedule means the disclosure schedule that has been delivered by F-Star to Company on the date hereof.
F-Star EIP means the F-Star Therapeutics Limited 2019 Equity Incentive Plan, as amended.
F-Star Equity Plans means the F-Star EIP and the F-Star Legacy Plans.
F-Star IP Rights means all IP Rights in which an F-Star Company has any right, title or interest or which are used or held for use by an F-Star Company.
F-Star Legacy Plans means the F-Star Alpha Limited Share Option Scheme, the F-Star Beta Limited Share Option Scheme and the F-Star EMI Share Option Scheme (each as amended).
F-Star Material Adverse Effect means any Effect that, considered together with all other Effects, has a material adverse effect on: (a) the business, financial condition, operations or results of operations of the F-Star Companies taken as a whole; provided, however, that, in no event will any of the following, alone or in combination, be deemed to constitute, nor will any of the following be taken into account in determining whether there has occurred, an F-Star Material Adverse Effect: Effects resulting from (i) conditions generally affecting the industries in which F-Star participates or the United States or global economy or capital markets as a whole, to the extent that such conditions do not have a disproportionate impact on the F-Star Companies, taken as a whole, relative to other companies in the industry in which the F-Star Companies operate; (ii) any failure by an F-Star Company to meet any estimates or expectations of its development programs, internal projections or forecasts or third party revenue or earnings predictions for any period ending (or for which revenues or earnings are released) on or after the date hereof (it being understood, however, that any Effect causing or contributing to such failures to meet projections or predictions may constitute an F-Star Material Adverse Effect and may be taken into account in determining whether an F-Star Material Adverse Effect has occurred); (iii) any failure by F-Star to meet F-Stars estimates or expectations of F-Stars development programs, any internal projections or forecasts for any period ending on or after the date hereof (it being understood, however, that any Effect causing or contributing to such failures to meet projections or forecasts may constitute a Company Material Adverse Effect and may be taken into account in determining whether a Company Material Adverse Effect has occurred); (iv) the execution, delivery, announcement or performance of the obligations under this Agreement or the
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announcement, pendency or anticipated consummation of the Contemplated Transactions; (v) any natural disaster or any acts of terrorism, sabotage, military action or war or any escalation or worsening thereof, or any viruses, pandemics, epidemic or other outbreak of illness or public health event, or any spread or worsening thereof, or any other Effect that may be considered a force majeure event; (vi) any changes (after the date hereof) in IFRS or GAAP or applicable Legal Requirements (or, in each case, the interpretation thereof) to the extent that such conditions do not have a disproportionate impact on the F-Star Companies, taken as a whole, relative to other companies in the industry in which the F-Star Companies operate; (vii) the taking of any action, or the failure to take any action, by any F-Star Company, that is required or reasonably necessary to comply with the terms of this Agreement or the taking of any action permitted by Part 5.2 of the F-Star Disclosure Schedule; (viii) any changes in or affecting research and development, clinical trials or other drug development activities (including the failure to obtain positive results from clinical trials, the occurrence of adverse events or serious adverse events in any clinical trial, development activities or favorable responses from any applicable Governmental Body) conducted by or on behalf of an F-Star Company or licensees in respect of F-Stars products or product candidates (it being understood, however, that any effect of any such adverse event or serious adverse event in any clinical trial (taking into account the intended patient population and phase of dose escalation of such clinical trial) on any F-Star Company may be taken into account in determining whether an F-Star Material Adverse Effect has occurred); (ix) any rejection or non-acceptance by a Governmental Body of a registration or filing by F-Star relating to any IP Rights of F-Star; or (x) regulatory approval of, or regulatory action or announcement with respect to, any product, or product candidates, of a third party that are similar to, or expected to compete against, any of F-Stars product candidates; or (b) the ability of F-Star or Sellers to consummate the Acquisition or to perform any of their respective covenants or obligations under this Agreement.
F-Star Option means any option to acquire shares in the capital of F-Star issued pursuant to any F-Star Option Plan.
F-Star Option Plans means the F-Star EIP, F-Star Alpha Limited Share Option Scheme, F-Star Beta Limited Share Option Scheme, and F-Star EMI Share Option Scheme.
F-Star Owned IP Rights shall mean all F-Star Registered IP Rights owned by any F-Star Company and all other IP Rights owned by any F-Star Company that were developed by an F-Star Company or were developed by a third party and subsequently assigned to any F-Star Company.
F-Star Personnel means all the employees, directors and other officers of the F-Star Companies, and any other individuals engaged to perform services personally to the F-Star Companies.
F-Star Persons means Eliot Forster, Darlene Deptula-Hicks and John Fitzpatrick.
F-Star Pre-Closing Financing means the subscription for and issue of F-Star Ordinary Shares (including F-Star Ordinary Shares issued upon conversion of any 2019 Loan Notes issued after the date hereof) pursuant to the F-Star Pre-Closing Financing Agreements to be consummated prior to the Closing with aggregate gross cash proceeds to F-Star of the lesser of (i) the Subscribed Proceeds or (ii) the Target Proceeds.
F-Star Pre-Closing Financing Agreements means the Equity Commitment Letters, any Additional Equity Commitment Letters and the Subscription Agreement.
F-Star Share Capital means the F-Star Ordinary Shares, the F-Star Seed Preference Shares and the F-Star Series A Preference Shares.
F-Star Shares means the issued and outstanding F-Share Ordinary Shares, the F-Star Conversion Shares, the F-Star Ordinary Shares issued in the F-Star Pre-Closing Financing (including F-Star Ordinary Shares issued upon conversion of any 2019 Loan Notes issued after the date hereof), any F-Star Ordinary Shares issued upon the exercise at or prior to Closing of F-Star Options, and any F-Star Ordinary Shares issued upon the vesting at or prior to Closing of F-Star RSUs.
FDA means the United States Food and Drug Administration.
Governmental Body means any: (a) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; or
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(c) governmental or quasi-governmental authority of any nature (including any governmental executive, division, regulatory agency, department, agency, commission, instrumentality, official, ministry, fund, foundation, center, organization, unit, body or Entity and any court or other tribunal).
Hazardous Materials means any pollutant, chemical, substance and any toxic, infectious, carcinogenic, reactive, corrosive, ignitable or flammable chemical, or chemical compound, or hazardous substance, material or waste, whether solid, liquid or gas, that is subject to regulation, control or remediation under any Environmental Law, including crude oil or any fraction thereof, and petroleum products or by-products.
IA 1986 means the United Kingdoms Insolvency Act 1986.
Insolvency Proceedings means insolvency related proceedings, whether in or out of court, including proceedings or steps leading to any form of bankruptcy, liquidation, administration, receivership, arrangement or scheme with creditors, moratorium, stay or limitation of creditors rights, interim or provisional supervision by a court or court appointee, winding up or striking off or any event similar to any such events in any jurisdiction in which a Seller is resident or incorporated.
Investors means those Sellers listed in Schedule V who have executed and delivered an Equity Commitment Letter.
IP Rights means any and all of the following in any country or region: (a) Copyrights, Patent Rights, Trademark Rights (including domain name registrations), Trade Secrets, and other intellectual property rights; and (b) the right (whether at law, in equity, by Contract or otherwise) to enjoy or otherwise exploit any of the foregoing, including the rights to sue for and remedies against past, present and future infringements of any or all of the foregoing, and rights of priority and protection of interests therein under the Legal Requirements of any jurisdiction worldwide.
ITEPA means the United Kingdom Income Tax (Earnings and Pensions) Act 2003.
Legal Proceeding means any action, suit, litigation, arbitration, mediation, proceeding (including any civil, criminal, administrative, insolvency, bankruptcy, liquidation, administration, receivership, involuntary arrangement, compromise or schedule with creditors, moratorium, stay or limitation of creditors rights, interim or provisions supervision by a court or court appointee, winding up or striking off, or similar event, investigative or appellate proceeding), hearing, inquiry, audit, examination, conciliation, expert determination or investigation or other process commenced, brought, conducted or heard by or before, or otherwise involving, any court or other Governmental Body or any arbitrator or arbitration panel.
Legal Requirements means any federal, state, local, municipal, foreign or other law, statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Body (or under authority of Nasdaq or any other applicable securities exchange).
Measurement Time means 11:59 p.m., Eastern time, on the 10th day preceding the date of the Company Stockholders Meeting set forth in the Registration Statement at the time it is declared effective by the SEC.
Minimum Proceeds means $14.5 million.
Nasdaq means The Nasdaq Stock Market.
Net Cash means the sum of (without duplication) (a) in each as of the Cash Determination Time, the sum of (i) Companys and its Subsidiaries cash and cash equivalents (inclusive of aggregate cash proceeds from Permitted Dispositions paid to and actually received by Company on or prior to the Closing Date, in each case, to the extent not distributed to the Company Stockholders, without any contingency and excluding, for the avoidance of doubt, any earn-out, royalties, escrows, holdbacks, contingent payment amounts and any other monetary Liabilities associated with such Permitted Dispositions) and marketable securities, determined in a manner consistent with the manner in which such items were historically determined and in accordance with the Company Financials and the Company Balance Sheet, (ii) in the event that the Approved Transaction Agreement is executed and delivered on or prior to the Closing Date, an amount equal to any upfront payments that, as of the
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Closing Date, are earned by Company without condition pursuant to the Approved Development Agreement, such amount not to exceed $2,000,000, (iii) all prepaid expenses and deposits (to the extent creditable against any amounts set forth in (b)(i) below or refundable to Company or any of its Subsidiaries within one year after the Closing), up to an aggregate amount of $2,000,000, subject to the limitations set forth in Exhibit H, and (iv) expenses paid, or Liabilities incurred, by Company or any of its Subsidiaries prior to the Closing that are approved in writing to be paid to Company or any of its Subsidiaries pursuant to any directors and officers insurance policies in excess of the deductible thereunder, minus (b) in each case as of the Cash Determination Time, the sum of (i) all accounts payable and accrued expenses (including legal settlements that are not covered by directors and officers insurance policies, Transaction Costs and costs of the D&O Tail) of Company and its Subsidiaries, determined in a manner consistent with the manner in which such items were historically determined and in accordance with the Company Financials and the Company Balance Sheet, and any and all other bona fide current and long-term Liabilities of Company and its Subsidiaries payable in cash that would be required to be set forth in a balance sheet of Company and its Subsidiaries prepared in accordance with GAAP, in each case to the extent not paid or canceled at or prior to the Closing Date, (ii) any reserves for legal settlements, except to the extent such amounts are covered by insurance policies, (iii) the cash cost of any unpaid change of control payments or severance, termination or similar payments or obligations, including any COBRA-related obligations, that are or become due to any current or former employee, director or independent contractor of Company or any of its Subsidiaries before or after Closing, (iv) any Outstanding Lease Obligations, (v) any notice, termination or consent payments, fines or other payments to be made by Company or any of its Subsidiaries in connection with the termination of any existing Contract to which Company or any of its Subsidiaries is a party and to wind down all clinical trial programs of Company or any of its Subsidiaries, other than the STING Trial, and (vi) all accrued and unpaid Taxes of Company and its Subsidiaries (estimated with respect to current Tax liabilities), plus or minus (c) the net amount of any transaction expense reimbursement owed to, or transaction expense payment owed by, Company pursuant to Section 8.3(a). Notwithstanding the foregoing, in no event shall Net Cash be reduced by the amount of (v) any reimbursible costs or expenses of Company in connection with the performance of Companys obligations under the Approved Development Agreement, (w) any payment to holders of any Company 2016 Warrants that elect to receive the Black-Scholes value of such Company 2016 Warrants pursuant to the Fundamental Transactions section of such Company 2016 Warrants, (x) any costs or expenses, including attorneys fees or settlement costs, incurred in connection with any potential or actual security holder litigation arising or resulting from the Contemplated Transactions and that may be brought in connection with or on behalf of any Company securityholders interest in Company Common Stock (including all amounts paid or payable up to the retention amount of any insurance policy that covers or may cover such costs or expenses and amounts not covered by any such insurance policy), (y) any costs or expenses of Company in connection with Companys completion of the STING Trial or (z) any costs or expenses, including attorneys fees or settlement costs, incurred in connection with any exercise by any Company Stockholder of appraisal rights in connection with the Contemplated Transactions. In no event shall Net Cash exceed the Net Cash Limit. A sample calculation of Net Cash is set forth on Exhibit H for illustrative purposes only.
Net Cash shall be denominated in U.S. dollars and each component initially denominated in a different currency shall be converted based on the published Wall Street Journal rate as of the Cash Determination Time.
Net Cash Limit means (i) $17,840,000 plus (ii) the excess, if any, of the Subscribed Proceeds over the Minimum Proceeds.
Order means any order, writ, injunction, judgment or decree.
Organizational Documents means, collectively and as applicable, the certificate of incorporation, articles of incorporation, memorandum of association, articles of association, bylaws and other charter documents of a company.
Outstanding Lease Obligations means all monetary Liabilities of Company or any of its Subsidiaries whenever arising pursuant to that certain Lease Agreement, dated October 4, 2017 by and between Company and 35 Parkwood Realty LLC, as amended from time to time, in each case including any monetary Liabilities that
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relate to the assignment or early termination of such lease and monetary Liabilities that survive such termination; provided, however, that such monetary Liabilities shall be discounted to present value using the same discount rate that is used in the Company Financials; and provided, further, that in the event that Company assigns, sublets, transfers or otherwise conveys any rights under such Lease Agreement to a party and under terms reasonably acceptable to F-Star, and which party F-Star is reasonably satisfied is adequately capitalized to fulfill its obligations under the Lease Agreement, the monetary Liabilities that are assumed pursuant to such assignment, sublet, transfer or conveyance shall serve to reduce Companys Outstanding Lease Obligations for purposes of the Net Cash calculation, irrespective of whether Company has agreed on behalf of itself or its Affiliates to backstop or guarantee any existing payment or other obligations under such assignment, sublet, transfer or conveyance.
Patent Rights means all issued patents, pending patent applications and abandoned patents and patent applications provided that they can be revived (which for purposes of this Agreement will include utility models, design patents, industrial designs, certificates of invention and applications for certificates of invention and priority rights) in any country or region, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, reissues, re-examinations and extensions thereof.
Permitted Disposition means the sale, assignment, conveyance, license or other transfer by an Acquiring Company of some or all of the Permitted Disposition Assets on or prior to the Closing Date, other than the Approved Development Transaction.
Permitted Disposition Assets means IP Rights that are owned or purported to be owned by, assigned to, or exclusively licensed by, Company or its Subsidiaries and other assets of Company and its Subsidiaries, in each case used or held for use in the Companys STING (STimulator of INterferon Genes) antagonist and chronic hepatitis B virus (HBV) programs (the Legacy Programs). Permitted Disposition Assets shall not include (i) any of Companys assets (including IP Rights) used by Company in its research and development programs (other than the Legacy Programs), (ii) Company Contracts that pertain to Companys research and development programs other than the Legacy Programs or (iii) pre-clinical data and clinical data generated pursuant to Companys research and development programs other than the Legacy Programs, provided, that in the case of each of the items referred to in the foregoing clauses (i) through (iii), such items shall be excluded from Permitted Disposition Assets only if and to the extent that such items are not necessary or useful to the Legacy Programs.
Permitted Dividend means, in the event that Net Cash would otherwise exceed the Net Cash Limit, a cash dividend in the amount of such excess.
Person means any person, Entity, Governmental Body, or group (as used in Section 13(d)(3) of the Exchange Act).
Personal Data means a natural persons name, street address, telephone number, e-mail address, photograph, social security number, drivers license number, passport number or any other piece of information that allows the identification of a natural person.
A Partys Representatives include each Person that is or becomes (a) a Subsidiary or other Affiliate of such Party or (b) an officer, director, employee, partner, attorney, advisor, accountant, agent or representative of such Party or of any such Partys Subsidiaries or other Affiliates.
SEC means the Securities and Exchange Commission.
SEC Documents means each report, registration statement, proxy statement and other statements, reports, schedules, forms and other documents filed by Company with the SEC since January 1, 2018, including all amendments thereto.
Securities Act means the Securities Act of 1933, as amended.
Seller Majority means, as of any particular time, Sellers holding at least sixty-five percent (65%) of the shares of F-Star Share Capital (after giving effect to the Conversions).
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Sensitive Company Data means confidential and proprietary information of any Acquiring Company and each customer, channel partner, and other Person in each Acquiring Companys possession or control, including Personal Data.
Sensitive F-Star Company Data means confidential and proprietary information of any F-Star Company and each customer, channel partner, and other Person in each F-Star Companys possession or control, including Personal Data.
Shareholders Agreement means the amended and restated shareholders agreement dated 7 May 2019 between F-Star and certain of the Sellers (whether in their capacity as parties to that agreement on any date of restatement or otherwise joined as a party pursuant to a deed of adherence) as amended from time to time.
Subscribed Proceeds means, as of the Measurement Time, the aggregate dollar amount of the subscriptions for F-Star Ordinary Shares for which F-Star has received fully executed and delivered Equity Commitment Letters and Additional Equity Commitment Letters.
An Entity will be deemed to be a Subsidiary of another Person if such Person directly or indirectly owns, beneficially or of record, (a) an amount of voting securities of or other interests in such Entity that is sufficient to enable such Person to elect at least a majority of the members of such Entitys board of directors or other governing body, or (b) at least 50% of the issued or outstanding equity or financial interests of such Entity.
Subscription Agreement means the Subscription Agreement to be entered into among F-Star, the Investors party to the Equity Commitment Letters and the Additional Investors, if any, party to the Additional Equity Commitment Letters in connection with the F-Star Pre-Closing Financing.
Superior Offer means a bona fide written Acquisition Proposal (provided that, for purposes of this definition, (i) the references to 20% in clause (a) of the definition of Acquisition Transaction shall be deemed to be references to 50% and (ii) the reference to 20% in clause (b) of the definition of Acquisition Transaction shall be deemed to be a reference to 75%) made by a third party that was not obtained or made as a result of a breach of 6.10(a)(i) and which the board of directors of Company determines in good faith (after consultation with its outside legal counsel and financial advisor), and after taking into account all financial, legal, regulatory, and other aspects of such Acquisition Proposal (including the financing terms and the ability of such third party to finance such Acquisition Proposal): (a) to be reasonably likely to be consummated if accepted; and (b) to be more favorable to Company Stockholders from a financial point of view than the Acquisition, taking into account any changes to the terms of this Agreement offered by F-Star or Sellers in response to such Acquisition Proposal; provided, however, that, without limitation, any such offer will not be deemed to be a Superior Offer unless (A) no financing is required to consummate the transaction contemplated by such offer or (B) financing is required to consummate the transaction contemplated by such offer and either (1) such financing is committed subject to conditions no less favorable to the Company than those set forth in the F-Star Pre-Closing Financing Agreements or (2) the board of directors of Company determines in good faith that such financing is reasonably capable of being obtained by such third party.
Target Proceeds means $25,000,000.
Tax and Taxes means any federal, state, local, or non-U.S. taxes imposed by a Governmental Body, including taxes on or with respect to income, gross receipts, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, customs duties, capital stock, franchise, profits, withholding, social security (or similar), unemployment, disability, real property, personal property, sales, use, transfer, registration, value added, alternative or add-on minimum, estimated, or other tax of any kind whatsoever, including any interest, penalty, or addition thereto, whether disputed or not.
Tax Return means any report, return (including information return), claim for refund, election, estimated tax filing, declaration or similar return filed, supplied or required to be filed with any Governmental Body with respect to Taxes, including any election, notification, appendix schedule or attachment thereto, and including any amendments thereof.
Term Sheet means the term sheet for the Approved Development Transaction disclosed to F-Star in Companys data room prior to the date hereof.
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Trade Secrets means trade secrets, know-how, proprietary information, inventions, discoveries, improvements, technology, technical data and research and development, whether patentable or not.
Trademark Rights means all trademark rights that may exist or be created under the laws of any jurisdiction in the world including all material common law trademarks, registered trademarks, applications for registration of trademarks, material common law service marks, registered service marks, applications for registration of service marks, trade names, registered trade names and applications for registration of trade names, and Internet domain name registrations; and including all filings with the applicable Governmental Body indicating an intent to use any of the foregoing if not registered or subject to a pending application, and to the extent applicable all renewals and extensions thereof.
Transaction Costs means the aggregate amount of costs and expenses of the Acquiring Companies, collectively, incurred (or expected to be incurred based on receipt of a good faith written estimate) in connection with the negotiation, preparation and execution of this Agreement and the consummation of the Contemplated Transactions, including any brokerage fees and commissions, finders fees or financial advisory fees, any fees and expenses of counsel or accountants payable by any Acquiring Company, Taxes, and any transaction bonuses or similar items, in each case to the extent unpaid.
2019 Loan Note Holder means a Seller that is a holder of a 2019 Loan Note.
2019 Loan Note Instrument means the convertible loan note instrument executed by F-Star on 19 September 2019, as amended, setting out the conditions subject to which the 2019 Loan Notes were and shall be issued.
2019 Loan Notes means the $30,000,000 unsecured convertible loan notes created pursuant to a resolution of the directors of F-Star passed on 19 September 2019 and issued prior to or after the date hereof.
Additionally, the following terms have the meanings assigned to such terms in the Sections of this Agreement set forth below opposite such term:
2019 Loan Note Conversion1.6(b)
Acceptable Company Confidentiality Agreement6.10(a)(i)
Accounting Firm1.5(e)
Acquisition1.1
Acquisition Consideration1.4(a)
Action5.1(t)
Additional Equity Commitment LettersRecitals
Additional InvestorRecitals
Additional InvestorsRecitals
AgreementPreamble
Allocation Certificate6.17
Anticipated Closing Date1.5(a)
Assumed Plan6.15(a)(i)
Beta2.4(a)
Cash Determination Time1.5(a)
Clinical Trial Tail6.5(b)
Closing1.2
Closing Date1.2
CompanyPreamble
Company Balance Sheet3.5(d)
Company Board Recommendation6.2(b)
Company Capital Stock3.2(a)
Company Change in Recommendation6.2(c)
Company Contract3.16(b)
Company Employee Plans3.12(a)
Company Financials3.5(d)
Company IP Assignment Agreements3.8(e)
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Company Lock-up AgreementsRecitals
Company Out Licenses3.8(c)
Company Permits3.9(b)
Company Preferred Stock3.2(a)
Company Registered IP Rights3.8(d)
Company Stockholder Approval3.3(a)
Company Stockholders Meeting6.2(a)
Company Termination Fee8.3(b)
Company Voting AgreementRecitals
Confidentiality Agreement6.3
CVR1.7(a)
CVR Agreements1.7(a)
CVRs1.7(a)
D&O Indemnified Parties6.5(a)
D&O Tail6.5(b)
Deed of Termination-Shareholders Agreement1.8(c)(ii)
Delaware Law2.22
Delivery Date1.5(a)
Dispute Notice1.5(b)
Equity Commitment Exchange6.30
Equity Commitment Exchange Amount6.30
ERISA2.11(a)
Exchange Act1.7(b)
Exchange Agent1.9(a)
Form S-46.1(a)
F-StarPreamble
F-Star Alpha Legacy Options6.15(b)
F-Star Audited Financials2.4(a)
F-Star Beta Legacy Options6.15(c)
F-Star Contract2.15(b)
F-Star Conversion SharesRecitals
F-Star EIP Options6.15(a)
F-Star Employee Plans2.11(a)
F-Star Financials2.4(b)
F-Star Gmbh Legacy Options6.15(d)
F-Star Issued Share Capital2.2(a)
F-Star Ordinary Shares2.2(a)
F-Star Permits2.8(b)
F-Star Predecessor Audited Financials2.4(a)
F-Star Predecessor Group2.4(a)
F-Star Registered IP Rights2.7(d)
F-Star Replacement ESOP Plan Rules6.16(a)
F-Star RSUs6.15(a)
F-Star Seed Preference Shares2.2(a)
F-Star Series A Preference Shares2.2(a)
F-Star Termination Fee8.3(d)
F-Star Unaudited Financials2.4(b)
GAAP3.5(c)
GmbH2.4(a)
IFRS2.4(a)
Insurance Policies2.17(a)
IP Assignment Agreements2.7(e)
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Joinder Agreement6.11(b)
knowledge of Company9.15(e)
knowledge of F-Star9.15(e)
Liability2.4(d)
Net Cash Calculation1.5(a)
Net Cash Schedule1.5(a)
Notice Period6.2(c)
Original EIP Option6.15(a)(iv)
Original EIP RSU6.15(a)(xi)
Out Licenses2.7(c)
PartiesPreamble
PartyPreamble
Permitted Transferee6.11(b)
Pre-Closing Period5.1
Proxy Statement6.1(a)
Registration Statement6.1(a)
Replacement EIP Option6.15(a)(ii)
Replacement EIP RSU6.15(a)(ix)
Response Date1.5(b)
Security Trustee6.16(a)
Seller Lock-up AgreementsRecitals
SellersPreamble
Share Charge6.16(b)
Share ConversionRecitals
STING Agonist CVR1.7(a)
STING Agonist CVR Agreement1.7(a)
STING Antagonist CVR1.7(a)
STING Antagonist CVR Agreement1.7(a)
STING Trial5.1(s)
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EXHIBIT B
FORM OF COMPANY LOCK-UP AGREEMENT
Company Lock-Up Agreement
[●], 2020
F-Star Therapeutics Limited.
Eddeva B920
Babraham Research Campus
Cambridge, CB22 3AT
UK
Re:F-Star Therapeutics Limited
Ladies and Gentlemen:
The undersigned of this lock-up agreement (this Lock-Up Agreement) understands that Spring Bank Pharmaceuticals, Inc., a Delaware corporation (Company), proposes to enter into a Share Exchange Agreement (the Share Exchange Agreement) with F-Star Therapeutics Limited, a company registered in England and Wales with company number 11532458 (F-Star), and the Persons listed on Schedule I to the Share Exchange Agreement (the Sellers), pursuant to which the Sellers will sell, transfer and convey to Company, and Company will purchase from Sellers, all of the issued and outstanding F-Star Shares (the Acquisition) on the terms set forth in the Share Exchange Agreement. Capitalized terms used herein and not otherwise defined shall have the respective meanings set forth in the Share Exchange Agreement.
As a material inducement to each of Company, F-Star and the Sellers to enter into the Share Exchange Agreement and to consummate the Contemplated Transactions, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the undersigned hereby agrees that, without the prior written consent of F-Star, the undersigned will not, during the period commencing on the date hereof and ending on the date that is 180 days after the Closing Date (the Lock-Up Period), directly or indirectly:
(i) |
offer, pledge, sell, contract to sell, sell any option, warrant or contract to purchase, purchase any option, warrant or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer, assign or dispose of (or enter into any transaction that is designed to, or could reasonably be expected to, result in the disposition (whether by actual disposition or effective economic disposition due to cash settlement or otherwise) by the undersigned or any Affiliate of the undersigned or any Person in privity with the undersigned or any Affiliate of the undersigned), or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended (the Exchange Act), with respect to, any shares of Company Common Stock or any securities convertible into or exercisable or exchangeable for Company Common Stock (including without limitation, Company Common Stock or such other securities which may be deemed to be beneficially owned by the undersigned in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant) (collectively, the Stockholders Shares); |
(ii) |
enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Company Common Stock or such other securities, in each case above, that are currently or hereafter owned either of record or beneficially (as defined in Rule 13d-3 under the Exchange Act) by the undersigned and whether any such transaction described in this clause (ii) or clause (i) above is to be settled by delivery of Company Common Stock or such other securities, in cash or otherwise; |
(iii) |
make any demand for or exercise any similar right with respect to the registration of any shares of Company Common Stock or any security convertible into or exercisable or exchangeable for Company Common Stock; |
(iv) |
except for the Company Voting Agreement, grant any proxies or powers of attorney with respect to any of the Stockholders Shares, deposit any of the Stockholders Shares into a voting trust or enter into a |
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voting agreement or similar arrangement or commitment with respect to any of the Stockholders Shares; or |
(v) |
publicly disclose the intention to do any of the foregoing. |
The restrictions and obligations contemplated by this Lock-Up Agreement shall not apply to:
(a) |
transfers of Company Common Stock or securities convertible into or exercisable or exchangeable for Company Common Stock: |
(i) |
if the undersigned is a natural person, (A) to a Family Member or a trust formed for the benefit of the undersigned or the undersigneds Family Member, (B) the undersigneds estate, (C) by bona fide gift, will or intestacy, or (D) any partnership, corporation or limited liability company which is controlled by the undersigned or any such Family Member(s); |
(ii) |
if the undersigned is a corporation, partnership or other business entity, (A) to another corporation, partnership or other business entity that is an affiliate (as defined under Rule 12b-2 of the Exchange Act) of the undersigned, including investment funds or other entities under common control or management with the undersigned, (B) any distribution or dividend to equity holders (including, without limitation, general or limited partners and members) of the undersigned (including upon the liquidation and dissolution of the undersigned pursuant to a plan of liquidation approved by the undersigneds equity holders) or (C) as a bona fide gift to a charitable organization; or |
(iii) |
if the undersigned is a trust, to a grantor or beneficiary of the trust; |
provided, that in the case of any transfer or distribution pursuant to this clause (a), such transfer is not for value and each donee, heir, beneficiary or other transferee or distributee shall sign and deliver to Company a lock-up agreement in the form of this Lock-Up Agreement;
(b) |
the exercise of options or warrants to purchase shares of Company Common Stock or the receipt of shares of Company Common Stock upon the vesting of restricted stock awards or vesting and settlement of restricted stock units or performance share units and any related transfer of shares of Company Common Stock to Company or sales of Company Common Stock (i) deemed to occur upon the cashless exercise of such options or exercise of such warrants or (ii) for the purpose of paying the exercise price of such options or warrants or for paying taxes (including estimated taxes) due as a result of the exercise of such options or warrants or as a result of the vesting of such shares of Company Common Stock under such restricted stock awards or the vesting and settlement of such restricted stock units or performance share units (or the disposition to Company of any shares of restricted stock granted pursuant to the terms of any employee benefit plan); provided that if any filing is required under Section 16(a) of the Exchange Act in connection with such exercise, sale of Company Common Stock, or receipt, such filing shall include a statement to the effect that such filing and sale, if applicable, is the result of the exercise or receipt of equity-based securities pursuant to the Companys equity incentive plans; |
(c) |
transfers by the undersigned of securities acquired in the open market following the Closing; or |
(d) |
the establishment of a trading plan that satisfies all of the requirements of Rule 10b5-1 under the Exchange Act (a 10b5-1 Plan) for the transfer of shares of Company Common Stock; provided that no transfers or sales of Company Common Stock or securities convertible into, or exchangeable or exercisable for, Company Common Stock, shall be made pursuant to such 10b5-1 Plan prior to the expiration of the Lock-Up Period; provided further, that if any announcement or filing under the Exchange Act regarding the establishment or existence of such 10b5-1 Plan shall be required or made voluntarily by the undersigned, the Company or any other person prior to the expiration of the Lock-Up Period, such announcement shall include a statement that sales under such 10b5-1 Plan will not occur until after the expiration of the Lock-Up Period; |
provided, further, that in the case of any such transfer, distribution, sale or other arrangement pursuant to any of the foregoing clauses (a) through (d), no filing by any party (donor, donee, transferor or transferee) or the undersigned, or any director affiliated with any party (donor, donee, transferor or
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transferee) or the undersigned, under the Exchange Act, or other public announcement shall be required or shall be made voluntarily in connection with such transfer, distribution, sale or other arrangement, other than a filing on a Form 5 made after the expiration of the Lock-Up Period.
For the avoidance of doubt, in no event shall the terms of this Lock-Up Agreement apply to any shares purchased in the public market following the Closing Date.
Any attempted transfer in violation of this Lock-Up Agreement will be of no effect and null and void, regardless of whether the purported transferee has any actual or constructive knowledge of the transfer restrictions set forth in this Lock-Up Agreement, and will not be recorded on the share register of Company. In furtherance of the foregoing, the undersigned agrees that Company and any duly appointed transfer agent for the registration or transfer of the securities described herein are hereby authorized to decline to make any transfer of securities if such transfer would constitute a violation or breach of this Lock-Up Agreement. F-Star may cause the legend set forth below, or a legend substantially equivalent thereto, to be placed upon any certificate(s) or other documents, ledgers or instruments evidencing the Stockholders Shares:
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO AND MAY ONLY BE TRANSFERRED IN COMPLIANCE WITH A LOCK-UP AGREEMENT, A COPY OF WHICH IS ON FILE AT THE PRINCIPAL OFFICE OF THE COMPANY.
The undersigned hereby represents and warrants that the undersigned has full power and authority to enter into this Lock-Up Agreement. All authority herein conferred or agreed to be conferred and any obligations of the undersigned shall be binding upon the successors, assigns, heirs or personal representatives of the undersigned.
The undersigned understands that (a) this Lock-Up Agreement is irrevocable and is binding upon the undersigneds heirs, legal representatives, successors and assigns and (b) if the Share Exchange Agreement is terminated pursuant to its terms, the undersigned shall be automatically released from all restrictions and obligations under this Lock-Up Agreement.
Any and all remedies herein expressly conferred upon F-Star and Company will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by law or equity, and the exercise by F-Star and/or Company of any one remedy will not preclude the exercise of any other remedy. The undersigned agrees that irreparable damage would occur to F-Star and Company in the event that any provision of this Lock-Up Agreement were not performed in accordance with its specific terms or were otherwise breached. It is accordingly agreed that F-Star and Company shall be entitled to an injunction or injunctions to prevent breaches of this Lock-Up Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which F-Star and Company are entitled at law or in equity, and the undersigned waives any bond, surety or other security that might be required of F-Star or Company with respect thereto.
This Lock-Up Agreement and any claim, controversy or dispute arising under or related to this Lock-Up Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to any laws, rules or provisions that would cause the application of the laws of any other jurisdiction other than the State of Delaware.
The undersigned agrees that, to the extent that the terms of this Lock-Up Agreement conflict with or are in any way inconsistent with any prior investor rights agreement, prior registration rights agreement, prior market standoff agreement or any other prior lock-up or similar prior agreement to which the undersigned and either F-Star or Company may be a party, this Lock-Up Agreement supersedes such prior agreement.
This Lock-Up Agreement may be executed by facsimile or electronic (i.e., PDF) transmission, which is deemed an original.
[Remainder of page intentionally left blank; signature page follows]
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EXHIBIT C
FORM OF SELLER LOCK-UP AGREEMENT
Seller Lock-Up Agreement
[●], 2020
F-Star Therapeutics Limited.
Eddeva B920
Babraham Research Campus
Cambridge, CB22 3AT
UK
Re:F-Star Therapeutics Limited
Ladies and Gentlemen:
The undersigned of this lock-up agreement (this Lock-Up Agreement) understands that Spring Bank Pharmaceuticals, Inc., a Delaware corporation (Company), proposes to enter into a Share Exchange Agreement (the Share Exchange Agreement) with F-Star Therapeutics Limited, a company registered in England and Wales with company number 11532458 (F-Star), and the Persons listed on Schedule I to the Share Exchange Agreement (the Sellers), pursuant to which the Sellers will sell, transfer and convey to Company, and Company will purchase from Sellers, all of the issued and outstanding F-Star Shares (the Acquisition) on the terms set forth in the Share Exchange Agreement. Capitalized terms used herein and not otherwise defined shall have the respective meanings set forth in the Share Exchange Agreement.
As a material inducement to each of Company, F-Star and the Sellers to enter into the Share Exchange Agreement and to consummate the Contemplated Transactions, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the undersigned hereby agrees that, without the prior written consent of F-Star, the undersigned will not, during the period commencing on the date hereof and ending on the date that is 180 days after the Closing Date (the Lock-Up Period), directly or indirectly:
(vi) |
offer, pledge, sell, contract to sell, sell any option, warrant or contract to purchase, purchase any option, warrant or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer, assign or dispose of (or enter into any transaction that is designed to, or could reasonably be expected to, result in the disposition (whether by actual disposition or effective economic disposition due to cash settlement or otherwise) by the undersigned or any Affiliate of the undersigned or any Person in privity with the undersigned or any Affiliate of the undersigned), or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended (the Exchange Act), with respect to, any shares of Company Common Stock or any securities convertible into or exercisable or exchangeable for Company Common Stock (including without limitation, Company Common Stock or such other securities which may be deemed to be beneficially owned by the undersigned in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant) (collectively, the Stockholders Shares); |
(vii) |
enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Company Common Stock or such other securities, in each case above, that are currently or hereafter owned either of record or beneficially (as defined in Rule 13d-3 under the Exchange Act) by the undersigned and whether any such transaction described in this clause (ii) or clause (i) above is to be settled by delivery of Company Common Stock or such other securities, in cash or otherwise; |
(viii) |
make any demand for or exercise any similar right with respect to the registration of any shares of Company Common Stock or any security convertible into or exercisable or exchangeable for Company Common Stock; |
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(ix) |
grant any proxies or powers of attorney with respect to any of the Stockholders Shares, deposit any of the Stockholders Shares into a voting trust or enter into a voting agreement or similar arrangement or commitment with respect to any of the Stockholders Shares; or |
(x) |
publicly disclose the intention to do any of the foregoing. |
The restrictions and obligations contemplated by this Lock-Up Agreement shall not apply to:
(e) |
transfers of Company Common Stock or securities convertible into or exercisable or exchangeable for Company Common Stock: |
(iv) |
if the undersigned is a natural person, (A) to a Family Member or a trust formed for the benefit of the undersigned or the undersigneds Family Member, (B) the undersigneds estate, (C) by bona fide gift, will or intestacy, or (D) any partnership, corporation or limited liability company which is controlled by the undersigned or any such Family Member(s); |
(v) |
if the undersigned is a corporation, partnership or other business entity, (A) to another corporation, partnership or other business entity that is an affiliate (as defined under Rule 12b-2 of the Exchange Act) of the undersigned, including investment funds or other entities under common control or management with the undersigned, (B) any distribution or dividend to equity holders (including, without limitation, general or limited partners and members) of the undersigned (including upon the liquidation and dissolution of the undersigned pursuant to a plan of liquidation approved by the undersigneds equity holders) or (C) as a bona fide gift to a charitable organization; or |
(vi) |
if the undersigned is a trust, to a grantor or beneficiary of the trust; |
provided, that in the case of any transfer or distribution pursuant to this clause (a), such transfer is not for value and each donee, heir, beneficiary or other transferee or distributee shall sign and deliver to Company a lock-up agreement in the form of this Lock-Up Agreement;
(f) |
the exercise of options or warrants to purchase shares of Company Common Stock or the receipt of shares of Company Common Stock upon the vesting of restricted stock awards or vesting and settlement of restricted stock units or performance share units and any related transfer of shares of Company Common Stock to Company or sales of Company Common Stock (i) deemed to occur upon the cashless exercise of such options or exercise of such warrants or (ii) for the purpose of paying the exercise price of such options or warrants or for paying taxes (including estimated taxes) due as a result of the exercise of such options or warrants or as a result of the vesting of such shares of Company Common Stock under such restricted stock awards or the vesting and settlement of such restricted stock units or performance share units (or the disposition to Company of any shares of restricted stock granted pursuant to the terms of any employee benefit plan); provided that if any filing is required under Section 16(a) of the Exchange Act in connection with such exercise, sale of Company Common Stock, or receipt, such filing shall include a statement to the effect that such filing and sale, if applicable, is the result of the exercise or receipt of equity-based securities pursuant to the Companys equity incentive plans; |
(g) |
transfers by the undersigned of securities acquired in the open market following the Closing; |
(h) |
the establishment of a trading plan that satisfies all of the requirements of Rule 10b5-1 under the Exchange Act (a 10b5-1 Plan) for the transfer of shares of Company Common Stock; provided that no transfers or sales of Company Common Stock or securities convertible into, or exchangeable or exercisable for, Company Common Stock, shall be made pursuant to such 10b5-1 Plan prior to the expiration of the Lock-Up Period; provided further, that if any announcement or filing under the Exchange Act regarding the establishment or existence of such 10b5-1 Plan shall be required or made voluntarily by the undersigned, the Company or any other person prior to the expiration of the Lock-Up Period, such announcement shall include a statement that sales under such 10b5-1 Plan will not occur until after the expiration of the Lock-Up Period; or |
(i) |
the sale of shares of Company Common Stock by the holders of options granted by F-Star pursuant to the F-star EMI Share Option Scheme, the F-star Alpha Limited Share Option Scheme and the F-star |
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Beta Limited Share Option Scheme, for the purpose of paying the exercise price of such options or for paying taxes (including estimated taxes, and including also any primary or secondary national insurance contributions in the United Kingdom for which the holders of such options are liable) due as a result of the exercise, waiver or release of such options; or |
(j) |
the number of shares of Company Common Stock, if any, received in exchange for ordinary shares of F-Star purchased in the F-Star Pre-Closing Financing, |
provided, further, that in the case of any such transfer, distribution, sale or other arrangement pursuant to any of the foregoing clauses (a) through (e), no filing by any party (donor, donee, transferor or transferee) or the undersigned, or any director affiliated with any party (donor, donee, transferor or transferee) or the undersigned, under the Exchange Act, or other public announcement shall be required or shall be made voluntarily in connection with such transfer, distribution, sale or other arrangement, other than a filing on a Form 5 made after the expiration of the Lock-Up Period.
For the avoidance of doubt, in no event shall the terms of this Lock-Up Agreement apply to any shares purchased in the public market following the Closing Date.
Any attempted transfer in violation of this Lock-Up Agreement will be of no effect and null and void, regardless of whether the purported transferee has any actual or constructive knowledge of the transfer restrictions set forth in this Lock-Up Agreement, and will not be recorded on the share register of Company. In furtherance of the foregoing, the undersigned agrees that Company and any duly appointed transfer agent for the registration or transfer of the securities described herein are hereby authorized to decline to make any transfer of securities if such transfer would constitute a violation or breach of this Lock-Up Agreement. F-Star may cause the legend set forth below, or a legend substantially equivalent thereto, to be placed upon any certificate(s) or other documents, ledgers or instruments evidencing the Stockholders Shares:
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO AND MAY ONLY BE TRANSFERRED IN COMPLIANCE WITH A LOCK-UP AGREEMENT, A COPY OF WHICH IS ON FILE AT THE PRINCIPAL OFFICE OF THE COMPANY.
The undersigned hereby represents and warrants that the undersigned has full power and authority to enter into this Lock-Up Agreement. All authority herein conferred or agreed to be conferred and any obligations of the undersigned shall be binding upon the successors, assigns, heirs or personal representatives of the undersigned.
The undersigned understands that (a) this Lock-Up Agreement is irrevocable and is binding upon the undersigneds heirs, legal representatives, successors and assigns and (b) if the Share Exchange Agreement is terminated pursuant to its terms, the undersigned shall be automatically released from all restrictions and obligations under this Lock-Up Agreement.
Any and all remedies herein expressly conferred upon F-Star and Company will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by law or equity, and the exercise by F-Star and/or Company of any one remedy will not preclude the exercise of any other remedy. The undersigned agrees that irreparable damage would occur to F-Star and Company in the event that any provision of this Lock-Up Agreement were not performed in accordance with its specific terms or were otherwise breached. It is accordingly agreed that F-Star and Company shall be entitled to an injunction or injunctions to prevent breaches of this Lock-Up Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which F-Star and Company are entitled at law or in equity, and the undersigned waives any bond, surety or other security that might be required of F-Star or Company with respect thereto.
This Lock-Up Agreement and any claim, controversy or dispute arising under or related to this Lock-Up Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to any laws, rules or provisions that would cause the application of the laws of any other jurisdiction other than the State of Delaware.
The undersigned agrees that, to the extent that the terms of this Lock-Up Agreement conflict with or are in any way inconsistent with any prior investor rights agreement, prior registration rights agreement, prior market
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standoff agreement or any other prior lock-up or similar prior agreement to which the undersigned and either F-Star or Company may be a party, this Lock-Up Agreement supersedes such prior agreement.
This Lock-Up Agreement may be executed by facsimile or electronic (i.e., PDF) transmission, which is deemed an original.
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Execution Version
EXHIBIT D
FORM OF COMPANY VOTING AGREEMENT
VOTING AGREEMENT
THIS VOTING AGREEMENT, dated [●], 2020 (this Agreement), is entered into by and between F-Star Therapeutics Ltd., a company registered in England and Wales with company number 11532458 (F-Star), and [●] (Stockholder), with respect to (i) Company Common Stock, (ii) all securities exchangeable, exercisable or convertible into Company Common Stock, and (iii) any securities issued or exchanged with respect to Company Common Stock, and upon any recapitalization, reclassification, merger, consolidation, spin-off, partial or complete liquidation, stock dividend, split-up or combination of the securities of Company or upon any other change in Companys capital structure, in each case whether now owned or hereafter acquired by Stockholder (collectively, the Securities). Capitalized terms used in this Agreement and not defined have the meaning given to such terms in the Share Exchange Agreement (as defined herein).
WITNESSETH
WHEREAS, concurrently with the execution of this Agreement, F-Star, Company, and each of the Sellers have entered into a Share Exchange Agreement, dated as of the date hereof (as the same may be amended or supplemented, the Share Exchange Agreement) pursuant to which, upon the terms and subject to the conditions thereof, the Sellers will sell, transfer and convey to Company, and Company will purchase from Sellers, all of the issued and outstanding F-Star Shares (the Acquisition);
WHEREAS, as a condition and inducement of F-Stars and the Sellers willingness to enter into the Share Exchange Agreement, Stockholder has agreed to execute and deliver this Agreement concurrently with the execution and delivery of the Share Exchange Agreement by the parties thereto; and
WHEREAS, as of the date hereof, Stockholder beneficially owns and has the power to dispose of the Securities set forth opposite Stockholders name on Schedule I hereto, and has the power to vote such Securities.
NOW, THEREFORE, in contemplation of the foregoing and in consideration of the mutual agreements, covenants, representations and warranties contained herein and intending to be legally bound hereby, the parties hereto agree as follows:
1. Certain Covenants.
1.1 No Transfers or Adverse Actions. Except as contemplated by the Share Exchange Agreement or Stockholders Company Lock-up Agreement, Stockholder hereby covenants and agrees that between the date hereof and the Termination Date (as defined below), Stockholder agrees not to, directly or indirectly, (a) create any Encumbrance, other than restrictions imposed by any Legal Requirements or pursuant to this Agreement, on any Securities, (b) transfer, sell, tender, assign, gift, pledge, hedge or otherwise dispose of, or enter into any derivative arrangement with respect to (collectively, Transfer), or enter into any Contract with respect to any Transfer of, any Securities or any interest therein, (c) grant or permit the grant of any proxy, power of attorney or other authorization in or with respect to any Securities, (d) deposit or permit the deposit of any Securities into a voting trust or enter into a voting agreement or arrangement with respect to any Securities or (e) take any action that would make any representation or warranty of Stockholder herein untrue or incorrect in any material respect, or have the effect of preventing or disabling Stockholder from performing Stockholders obligations under this Agreement or that would, or would reasonably be expected to, have the effect of preventing, materially delaying or materially impairing, the consummation of the Contemplated Transactions or the performance by Company of its obligations under the Share Exchange Agreement. Any action taken in violation of the immediately preceding sentence shall be null and void ab initio. Notwithstanding the foregoing, Stockholder may make Transfers of the Securities (i) by will, operation of law, or for estate planning or charitable purposes, (ii) if Stockholder is a trust, to any beneficiary of Stockholder or the estate of any such beneficiary or (iii) as F-Star may otherwise agree in writing in its sole discretion; provided that in each such case, the Securities shall continue to be bound by this Agreement and provided that each transferee agrees in writing, in form and substance reasonably satisfactory to F-Star, to be bound by the terms and conditions of this Agreement.
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1.2 No Solicitation. Between the date hereof and the Termination Date, Stockholder shall not, and shall not authorize or permit, any Representative of Stockholder or those of Stockholders Subsidiaries (if any) to, directly or indirectly, take any action, in Stockholders or their capacity as a stockholder of Company, that Company is prohibited from taking pursuant to Section 6.10(a) of the Share Exchange Agreement.
1.3 Certain Events. This Agreement and the obligations hereunder will attach to the Securities and will be binding upon any Person to which legal or beneficial ownership (the term or concept of beneficial ownership for purposes of this Agreement having the meaning assigned thereto in Section 13(d) of the Exchange Act and the rules and regulations thereunder) of any or all of the Securities passes, whether by operation of Legal Requirements or otherwise, including without limitation, Stockholders successors or assigns. This Agreement and the obligations hereunder will also attach to any additional Securities issued to or acquired by any Stockholder after the date hereof.
1.4 Voting Agreement; Grant of Proxy.
(a) During the term of this Agreement, Stockholder agrees to (i) vote the Securities in favor of or give consent to, as applicable, (A) any proposal or proposals to (x) approve the Company Stockholder Approval Matters at any annual or special meeting of the Company Stockholders, (y) if deemed necessary, adopt an amendment to Companys certificate of incorporation to change the name of Company, and (z) adjourn or postpone an annual or special meeting to a later date if there are not sufficient votes for the approval of any of the Company Stockholder Approval Matters; and (B) any other proposals included in the Proxy Statement in connection with, or related to the consummation of, the Contemplated Transactions for which the board of directors of Company has recommended that the Company Stockholders vote in favor; and (ii) vote the Securities against and not consent to, as applicable, (x) any action, proposal, transaction or agreement that, to the knowledge of Stockholder, would reasonably be expected to result in a breach in any material respect of any covenant, representation or warranty or any other obligation or agreement of Company under the Share Exchange Agreement or that would reasonably be expected to result in any of Companys or any Sellers obligations under the Share Exchange Agreement not being fulfilled and (y) any competing Acquisition Proposal or any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the Contemplated Transactions.
(b) Stockholder hereby appoints F-Star and any designee of F-Star as attorney-in-fact and proxy for and on behalf of Stockholder, for and in the name, place and stead of Stockholder, to (i) attend any and all meetings of the Company Stockholders, (ii) vote, express consent or dissent or issue instructions to the record holder to vote the Securities in accordance with the provisions of Section 1.4(a) at any and all meetings of the Company Stockholders (or at any adjournment thereof) or in connection with any action sought to be taken by written consent of the Company Stockholders without a meeting and (iii) grant or withhold, or issue instructions to the record holder to grant or withhold, consistent with the provisions of Section 1.4(a), all written consents with respect to the Securities at any and all meetings of the Company Stockholders (or at any adjournment thereof) or in connection with any action sought to be taken by written consent without a meeting. F-Star hereby acknowledges that the proxy granted hereby shall not be effective for any other purpose. The parties acknowledge and agree that none of F-Star or any of F-Stars successors, assigns, subsidiaries, divisions, employees, officers, directors, stockholders, agents or Affiliates shall owe any duty to, whether in law or otherwise, or incur any Liability of any kind whatsoever, including with respect to any and all claims, losses, demands, causes of action, costs, expenses (including attorneys fees) and compensation of any kind or nature whatsoever to Stockholder, in connection with or as a result of any voting by F-Star of the Securities subject to the irrevocable proxy hereby granted to F-Star at any meeting of the Company Stockholders for the purpose set forth herein. The foregoing proxy shall be deemed to be a proxy coupled with an interest hereunder, is irrevocable (and as such shall survive and not be affected by the death, incapacity, mental illness or insanity of Stockholder, as applicable) until the termination of the Share Exchange Agreement and shall not be terminated by operation of law or any act of Stockholder or upon the occurrence of any other event other than the termination of this Agreement. Stockholder hereby affirms that the proxy set forth in this Section 1.4(b) is given in connection with and granted in consideration of and as an inducement to F-Star to enter into the Share Exchange Agreement and that such proxy is given to secure the obligations of Stockholder under Section
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1.4(a). Stockholder hereby revokes or terminates any and all previously granted proxies, voting agreements or similar arrangements previously given or entered into with respect to any of the Securities that may have heretofore been appointed or granted with respect to the matters referred to in Section 1.4(a), and no subsequent proxy (whether revocable or irrevocable) shall be given by Stockholder with respect to the matters referred to in Section 1.4(a).
1.5 Public Announcement. Stockholder shall (a) consult with Company and F-Star before issuing any press release or otherwise making any public statement with respect to the Contemplated Transactions or this Agreement or the transactions contemplated hereby, (b) provide to Company and F-Star for review a copy of any such press release or public statement and (c) not issue any such press release or make any such public statement prior to such consultation and the receipt of the prior written consent of F-Star (which consent shall not be unreasonably withheld, conditioned or delayed); provided, however, that on the advice of outside legal counsel, Stockholder may issue a press release or public statement without the consent of F-Star if required by applicable Legal Requirements and Stockholder has (i) provided reasonable prior written notice to F-Star, (ii) provided a copy of any such press release or public statement for Companys and F-Stars review and (iii) considered any and all reasonable comments of F-Star thereon in good faith. This Section 1.5 shall terminate and be null and void upon the Termination Date.
1.6 Disclosure. Stockholder hereby authorizes Company and F-Star to publish and disclose in any announcement or disclosure that Company or F-Star reasonably determines to be necessary, in connection with the Contemplated Transactions, a copy of this Agreement, Stockholders identity and ownership of the Securities and the nature of Stockholders commitments, arrangements and understandings under this Agreement. F-Star hereby authorizes Stockholder to make such disclosure or filings as may be required by applicable Legal Requirements. Company is an intended third-party beneficiary of this Section 1.6.
1.7 No Exercise of Appraisal Rights; Waivers. In connection with the Contemplated Transactions, Stockholder hereby expressly (a) waives, to the extent permitted under applicable Legal Requirements, the applicability of the provisions for dissenters or appraisal rights set forth in Section 262 of Delaware Law (or any other similar applicable state Legal Requirements), with respect to any Securities, (b) agrees that Stockholder will not, under any circumstances in connection with the Contemplated Transactions, exercise or assert any dissenters or appraisal rights in respect of any Securities, and (c) agrees that Stockholder will not bring, commence, institute, maintain, prosecute, participate in or voluntarily aid any action, claim, suit or cause of action, in law or in equity, in any court or before any Governmental Body, which (i) challenges the validity of or seeks to enjoin the operation of any provision of this Agreement or (ii) alleges that the execution and delivery of this Agreement by Stockholder, or the approval of the Share Exchange Agreement by the board of directors of Company, breaches any fiduciary duty of the board of directors of Company or any member thereof; provided, that Stockholder may defend against, contest or settle any such action, claim, suit or cause of action brought against Stockholder that relates solely to Stockholders capacity as a director, officer or securityholder of Company.
2. Representations and Warranties of Stockholder. Stockholder hereby represents and warrants to F-Star as follows:
2.1 Ownership. Stockholder is the record or beneficial owner (as each is defined in Rule 13d-3 under the Exchange Act) of the Securities set forth opposite Stockholders name on Schedule I hereto, free and clear of all Encumbrances, except as set forth on Schedule I hereto. The Securities set forth opposite Stockholders name on Schedule I hereto constitute all of the shares of Company Common Stock, Company Options, Company RSUs and Company Warrants and any other securities of Company owned of record and beneficially by Stockholder as of the date hereof. Except pursuant to this Agreement, no Person has any contractual or other right or obligation to purchase or otherwise acquire any of Stockholders Securities. None of the Securities are subject to any proxy, voting trust or other agreement or arrangement with respect to the voting of the Securities, except as provided hereunder.
2.2 Authorization; Binding Agreement. Stockholder has all requisite power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby and has the power to vote
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and the power to dispose of the Securities with no restrictions on Stockholders voting rights or rights of disposition pertaining thereto, except as set forth in this Agreement or that may exist pursuant to the securities Legal Requirements. Stockholder has duly executed and delivered this Agreement and this Agreement is a legal, valid and binding agreement of Stockholder, enforceable against Stockholder in accordance with its terms, except to the extent enforceability may be limited by the effect of applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other Legal Requirements affecting creditors rights generally and general principles of equity (the Enforceability Limitations). If Stockholder is married, and any of the Securities constitute community property or otherwise need spousal or other approval for this Agreement to be legal, valid and binding, this Agreement has been duly and validly executed and delivered by Stockholders spouse and, assuming the due authorization, execution and delivery by F-Star, constitutes a legal, valid and binding obligation of Stockholders spouse, enforceable against Stockholders spouse in accordance with its terms, subject to the Enforceability Limitations.
2.3 No Violation. Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby will (a) if Stockholder is not an individual, violate, contravene or conflict with or result in any breach of any provision of the Organizational Documents of Stockholder, (b) require Stockholder to file or register with, or obtain any permit, authorization, consent or approval of, any Governmental Body (except for compliance with the applicable requirements of the Securities Act, the Exchange Act or any other United States or federal securities Legal Requirements), (c) result (or, with the giving of notice, the passage of time or otherwise, would result) in the creation or imposition of any Encumbrance on any asset of Stockholder, or (d) violate, or cause a breach of or default under, or conflict with any Contract or Legal Requirement to which Stockholder is a party or by which Stockholder or any of the Securities may be bound, except in the case of each of clauses (c) and (d) as would not reasonably be expected to prevent, materially delay or impair the ability of Stockholder to perform Stockholders obligations hereunder or to consummate the transactions contemplated hereby.
2.4 No Setoff. Stockholder has no liability or obligation related to or in connection with the Securities other than the obligations to F-Star as set forth in this Agreement.
2.5 Reliance. Stockholder has had the opportunity to review the Share Exchange Agreement and this Agreement with counsel of Stockholders own choosing. Stockholder understands and acknowledges that Company and F-Star are entering into the Share Exchange Agreement in reliance upon Stockholders execution, delivery and performance of this Agreement.
2.6 Absence of Legal Proceedings. There is no Legal Proceeding pending, or, to the knowledge of Stockholder, threatened against Stockholder or any of Stockholders properties or assets (including the Securities) that would reasonably be expected to prevent, materially delay or impair the ability of Stockholder to perform Stockholders obligations hereunder or to consummate the transactions contemplated hereby.
3. Representations and Warranties of F-Star. F-Star hereby represents and warrants to Stockholder as follows:
3.1 Organization. F-Star is a corporation duly organized and validly existing under the laws of the jurisdiction of its incorporation. The consummation of the transactions contemplated by this Agreement are within F-Stars corporate powers and have been duly authorized by all necessary corporate actions on the part of F-Star. F-Star has full power and authority to execute, deliver and perform this Agreement.
3.2 Authority; Binding Agreement. F-Star has duly executed and delivered this Agreement and this Agreement is a legal, valid and binding agreement of F-Star, enforceable against F-Star in accordance with its terms, subject to the Enforceability Exceptions.
4. Survival of Representations and Warranties. None of the representations and warranties contained in this Agreement shall survive the Termination Date. The representations and warranties of Stockholder and F-Star contained herein shall not be deemed waived or otherwise affected by any investigation made by the other party hereto.
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5. Specific Performance. Stockholder acknowledges that F-Star will be irreparably harmed and that there will be no adequate remedy at law for a violation of any of the covenants or agreements of Stockholder contained in this Agreement. It is accordingly agreed that, in addition to any other remedies which may be available to F-Star upon the breach by Stockholder of such covenants and agreements, F-Star shall have the right, subject to applicable Legal Requirements, to obtain injunctive relief to restrain any breach of such covenants or agreements or otherwise to obtain specific performance of any of such covenants or agreements. Each party hereto agrees that such party will not oppose the seeking of such relief on the basis that the other party hereto has an adequate remedy at law.
6. Miscellaneous.
6.1 Term. This Agreement and all obligations hereunder shall terminate upon the earlier of (a) the Closing and (b) the termination of the Share Exchange Agreement in accordance with its terms (the earliest of (a) and (b), the Termination Date). Upon termination of this Agreement, no party shall have any further obligations or Liabilities under this Agreement; provided, however, that (i) nothing set forth in this Section 6.1 shall relieve any party from Liability for any knowing breach (as such term is defined in Section 8.2 of the Share Exchange Agreement) and (ii) the provisions of this Article 6 shall survive any termination of this Agreement.
6.2 Capacity as a Stockholder; Fiduciary Duties. Notwithstanding anything in this Agreement to the contrary: (a) Stockholder makes no agreement or understanding herein in any capacity other than in Stockholders capacity as a record holder and beneficial owner of the Securities, and not in Stockholders capacity as a director, officer or employee of Company or any of its Subsidiaries or in Stockholders capacity as a trustee or fiduciary of any employee benefit plan or trust, and (b) nothing herein will be construed to limit or affect any action or inaction by Stockholder or any Representative of Stockholder, as applicable, serving on Companys board of directors or on the board of directors of any Subsidiary of Company or as an officer or fiduciary of Company, any Subsidiary of Company or any employee benefit plan or trust, acting in such Persons capacity as a director, officer, trustee and/or fiduciary.
6.3 No Ownership Interest. Nothing contained in this Agreement shall be deemed to vest in the Company or any of its Affiliates any direct or indirect ownership or incidence of ownership of or with respect to any Securities. All rights, ownership and economic benefit of and relating to the Securities shall remain vested in and belong to Stockholder, and Company shall have no authority to manage, direct, superintend, restrict, regulate, govern or administer any of the policies or operations of Stockholder or exercise any power or authority with respect to Stockholder in the voting of any Securities, except as specifically provided herein.
6.4 Conversion or Exercise. Nothing contained in this Agreement shall require Stockholder (or shall entitle any proxy of Stockholder) to (a) convert, exercise or exchange any Company Options, Company RSUs, Company Warrants or convertible securities in order to obtain any underlying Securities or (b) vote, or execute any consent with respect to, any Securities underlying such Company Options, Company RSUs, Company Warrants or convertible securities that have not yet been issued as of the applicable record date for such vote or consent.
6.5 Fees and Expenses. All costs and expenses incurred in connection with this Agreement and the consummation of the transactions contemplated hereby shall be paid by the party incurring such costs and expenses.
6.6 Amendments and Waivers. Any provision of this Agreement may not be amended or waived except by a written instrument executed by all parties to this Agreement, or their respective successors and assigns.
6.7 Entire Agreement. This Agreement contains the entire understanding of the parties hereto with respect to the subject matter contained herein and supersedes all prior agreements and understandings, oral and written, with respect thereto. No failure or delay by either party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
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6.8 Headings. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.
6.9 Assignment. Without limitation to Section 1.1 and subject to this Section 6.8, this Agreement shall be binding upon and inure to the benefit of, the parties hereto and their respective successors and permitted assigns; provided, that neither this Agreement nor any rights, interests or obligations hereunder may be assigned by any party hereto without the prior written consent of the other party hereto, and any attempted assignment of this Agreement or any of such rights, interests or obligations without such consent shall be void and of no effect.
6.10 Counterparts. This Agreement may be executed in several counterparts, and by the different parties hereto in separate counterparts and by facsimile or electronic (i.e., PDF) transmission, each of which when executed will be deemed to be an original but all of which taken together will constitute one and the same agreement.
6.11 Notices. Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed properly delivered, given and received: (a) if delivered by hand, when delivered; (b) if sent on a Business Day by email with confirmed receipt before 5:00 p.m. (recipients time) on the date sent, on such Business Day; (c) if sent by email on a day other than a Business Day, or if sent by email with confirmed receipt at any time after 5:00 p.m. (recipients time) on the date sent, on the date on which receipt is confirmed, if a Business Day, and otherwise on the first Business Day following the date on which receipt is confirmed; (d) if sent by registered, certified or first class mail, the third Business Day after being sent; and (e) if sent by overnight delivery via a national courier service, one Business Day after being sent, in each case to the address or email address set forth beneath the name of such party below (or to such other address or email address as such party shall have specified in a written notice given to the other parties hereto):
(a) if to F-Star, to:
F-Star Therapeutics Limited
Eddeva B920,
Babraham Research Campus
Cambridge, CB22 3AT, UK
Attn: John Fitzpatrick
Email: john.fitzpatrick@f-star.com
With a copy (which shall not constitute notice) to:
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
One Financial Center
Boston, MA 02111
Attn.: William C. Hicks; Matthew W. Tikonoff
Email: WCHicks@mintz.com;
MWTikonoff@mintz.com
Fax: (617) 542-2241
(b)if to Stockholder, to the address indicated on Schedule I hereto, with copies to Company and its outside counsel as provided in Section 9.1 of the Share Exchange Agreement.
Any party may, by notice given in accordance with this Section 6.10 to the other parties, designate updated information for notices hereunder.
6.12 Governing Law. This Agreement, all acts and transactions pursuant hereto and the legal relations between the parties hereto shall be governed by and construed and interpreted in accordance with the laws of the State of Delaware, without regard to the conflicts of laws rules thereof. Any action, suit or other disputes between the parties hereto relating to this Agreement or the enforcement of any provision of this Agreement will be brought or otherwise commenced exclusively in the Chancery Court of the State of Delaware located in Wilmington, Delaware and any state appellate court therefrom located in Wilmington, Delaware, or, if no such state court has proper jurisdiction, the Federal District Court for the District of Delaware located in Wilmington, Delaware, and any appellate court therefrom. The parties consent to and agree to submit to the exclusive
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jurisdiction of such courts. Each of the parties hereby waives and agrees not to assert in any such dispute, to the fullest extent permitted by applicable Legal Requirements, any claim that (i) such party is not personally subject to the jurisdiction of such courts, (ii) such party and such partys property are immune from any legal process issued by such courts or (iii) any litigation or other proceeding commenced in such courts is brought in an inconvenient forum. The parties hereby agree that mailing of process or other papers in connection with any such action or proceeding in the manner provided in Section 6.10, or in such other manner as may be permitted by applicable Legal Requirements, shall be valid and sufficient service thereof and hereby waive any objections to service accomplished in the manner herein provided.
6.13 Severability. If any term, provision, covenant or restriction contained in this Agreement is held by a court of competent jurisdiction or other authority to be invalid, void, unenforceable or against its regulatory policy, the remainder of the terms, provisions, covenants and restrictions contained in this Agreement shall, to the fullest extent permissible by applicable Legal Requirement, remain in full force and effect and shall in no way be affected, impaired or invalidated, and this Agreement shall, to the fullest extent permissible by applicable Legal Requirement, be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable term, provision, covenant or restriction or any portion thereof had never been contained herein.
6.14 Further Assurances. From time to time, at F-Stars request and without further consideration, subject to the terms and conditions of this Agreement, Stockholder shall execute and deliver to F-Star such documents and take such action as F-Star may reasonably request in order to consummate more effectively the transactions contemplated hereby.
6.15 Remedies Not Exclusive. All rights, powers and remedies provided under this Agreement or otherwise available in respect hereof at law or in equity will be cumulative and not alternative, and the exercise of any right thereof by either party will not preclude the simultaneous or later exercise of any other such right, power or remedy by such party.
6.16 WAIVER OF JURY TRIAL. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LEGAL REQUIREMENTS, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, SUIT OR OTHER LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
6.17 No Agreement Until Executed. Irrespective of negotiations among the parties or the exchanging of drafts of this Agreement, this Agreement shall not constitute or be deemed to evidence a contract, agreement, arrangement or understanding between the parties hereto unless and until (a) the Share Exchange Agreement is executed by all parties thereto and (b) this Agreement is executed by all parties hereto.
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IN WITNESS WHEREOF, the parties hereto have caused this Voting Agreement to be duly executed as of the date first above written.
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IN WITNESS WHEREOF, the parties hereto have caused this Voting Agreement to be duly executed as of the day and year first above written.
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Execution Version
EXHIBIT E-1
FORM OF STING AGONIST CVR AGREEMENT
CONTINGENT VALUE RIGHTS AGREEMENT
THIS CONTINGENT VALUE RIGHTS AGREEMENT, dated as of [●], 2020 (this Agreement), is entered into by and among Spring Bank Pharmaceuticals, Inc., a Delaware corporation (the Company), F-Star Therapeutics Limited., a company registered in England and Wales with company number 11532458 (F-Star), Computershare Trust Company N.A. (the Rights Agent) and initial CVR Registrar (as defined herein), and [●], acting solely in his capacity as representative of the Holders (as defined herein) (the Holder Representative). Capitalized terms not defined herein shall have the meanings ascribed to them in the Share Exchange Agreement (as defined below).
A. The Company, F-Star, and certain other Persons (the Sellers) have entered into a Share Exchange Agreement (the Share Exchange Agreement), pursuant to which the Sellers will sell to the Company, and the Company will purchase from the Sellers, all of the F-Star Shares (the Acquisition).
B. Pursuant to Section 1.7 of the Share Exchange Agreement, prior to the consummation of the Acquisition, the Company wishes to create and issue contractual contingent value rights relating to the CVR Assets (as defined herein) to the record holders of the Common Stock (as defined herein) as of a record date prior to the consummation of the Acquisition.
C. On [●], 2020, the Board of Directors of the Company authorized and declared a dividend of one CVR (as defined herein) for each share of Common Stock outstanding at 5:01 p.m. Eastern Time on the Record Date (as defined herein). The payment of such dividend will be conditioned upon, and such dividend will only become payable upon, the satisfaction or waiver of all conditions to the Acquisition and the occurrence of the time that is immediately prior to the consummation of the Acquisition. The Company will pay the dividend immediately prior to the consummation of the Acquisition.
Accordingly, and in consideration of the premises and the consummation of the transactions referred to above, it is mutually agreed, for the benefit of the Holders, as follows:
ARTICLE I
DEFINITIONS
1.1 Definitions.
(a) For all purposes of this Agreement, except as otherwise expressly provided or unless the context otherwise requires:
(i) all accounting terms used herein and not expressly defined herein have the meanings assigned to such terms in accordance with United States generally accepted accounting principles, as in effect on the date hereof;
(ii) unless the context otherwise requires, words describing the singular number include the plural and vice versa, words denoting any gender include all genders and words denoting natural Persons include corporations, partnerships and other Persons and vice versa;
(iii) the words include and including and variations thereof will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words without limitation;
(iv) the terms hereof, hereunder, herein and words of similar import refer to this Agreement as a whole and not to any particular Article, Section or provision of this Agreement; and
(v) the Article and Section headings contained in this Agreement are for reference purposes only and do not limit or otherwise affect any of the substance of this Agreement.
(b) The following terms have the meanings ascribed to them as follows:
Affiliates means, with respect to any Person, any other Person which directly or indirectly controls, is controlled by or is under common control with such first Person.
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Board of Directors means the board of directors of the Company.
Board Resolution means a copy of a resolution certified by the secretary or an assistant secretary of the Company to have been duly adopted by the Board of Directors and to be in full force and effect on the date of such certification, and delivered to the Rights Agent and the Holder Representative.
Business Day means a day other than a Saturday, Sunday or other day on which commercial banks located in Boston, Massachusetts or London, England are authorized or required by applicable Legal Requirements to close; provided, however, for clarification, commercial banks shall not be deemed to be authorized or required by applicable Legal Requirements to close due to stay at home, shelter-in-place, non-essential employee or any other similar orders or restrictions or the closure of any physical branch locations at the direction of any Governmental Body so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in such location generally are open for use by customers on such day.
Change of Control means any of the following transactions occurring after the Closing: (a) (i) any consolidation or merger of the Company with or into any other corporation or entity or Person or (ii) any other corporate reorganization, in which the stockholders of the Company immediately prior to such consolidation, merger or reorganization, own less than 50% of the voting power of the surviving entity immediately after such consolidation, merger or reorganization, except in the case of a bona fide capital raising transaction, or (b) any sale of all or substantially all of the assets of the Company.
Close of Business on any given date means 5:00 p.m., Eastern Time, on such date; provided, however, that if such date is not a Business Day it will mean 5:00 p.m., Eastern Time, on the next succeeding Business Day.
Combination CVR Asset Transaction means a transaction consummated at any time prior to the CVR Expiration Date consisting of the grant, sale, license or other transfer of both (a) any CVR Asset and/or Company Product, on the one hand, and (b) (x) any conjugate of such compound referenced in the foregoing clause (a) with one or more antibodies in the form of an antibody-drug conjugate or (y) any asset owned by any F-Star Company as of immediately prior to the Closing, on the other hand.
Commercially Reasonable Efforts means, with respect to the efforts and resources to be expended by the Company with respect to continuing the STING Trial and pursuing and seeking to consummate a CVR Transaction, such reasonable, good faith efforts and resources as a biotechnology company of a similar size and with similar financial and other resources would normally use to pursue its clinical development programs and pursue and seek to consummate such a transaction under similar circumstance for a similar product or product candidate owned by it, or to which it has similar rights, which product or product candidate is at a similar stage in its development and is of similar market potential taking into account all relevant factors; provided that, it is expressly understood and agreed that despite the use of such above described efforts, a CVR Transaction may not occur and the obligation to make a CVR Payment may not arise.
Common Stock means the common stock, $0.0001 par value, of the Company.
Company Product means any product that incorporates the proprietary STimulator of INterferon Genes (STING) agonist compound of the Company designated as SB 11285. For clarity, Company Product shall not include any conjugate of such compound with one or more antibodies in the form of an antibody-drug conjugate, including any antibodies owned or controlled by F-Star.
CVR means a contingent value right issued by the Company pursuant to this Agreement.
CVR Asset Transaction means a transaction consummated at any time prior to the CVR Expiration Date pursuant to which the Company or any of its Affiliates grants, sells, licenses or otherwise transfers to a Third Party some or all of the rights to the CVR Assets, including any rights to research, develop or commercialize the CVR Assets, including a license, option, or sale of assets with respect to the CVR Assets; provided, that any such transaction involving any asset other than a CVR Asset shall not constitute a CVR Asset Transaction.
CVR Assets means any Intellectual Property and other assets that are used or held for use for the development of a Company Product, including all (a) regulatory filings made with respect to a Company Product;
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(b) regulatory approvals received with respect to a Company Product; and (c) clinical and non-clinical safety, and efficacy and pharmacokinetic data generated with respect to a Company Product.
CVR Expiration Date means the later to occur of: (i) the date that is eighteen (18) months following the date of the Closing, or (ii) the one (1) year anniversary of the date of the final database lock of the STING Trial.
CVR Payment means an Initial CVR Payment Amount and a CVR Payment Adjustment Amount, if any.
CVR Payment Adjustment Amount means, as of any time following the payment hereunder of the Initial CVR Payment Amount (if at all), if twenty-five percent (25%) of aggregate Net Proceeds is greater than the Target Payment Amount, then an amount equal to (a) twenty-five percent (25%) of the aggregate Net Proceeds, minus (b) the aggregate amount of all CVR Payments received by the Holders pursuant to this Agreement prior to such time.
CVR Payment Date means the date (if any and if ever) that a CVR Payment is payable by the Company to the Holders, which date will be established pursuant to Section 2.4.
CVR Register has the meaning set forth in Section 2.3(b).
CVR Registrar has the meaning set forth in Section 2.3(b).
CVR Transaction means a CVR Asset Transaction or a Combination CVR Asset Transaction. For clarity, (a) the grant of a license to any Third Party (including any contract research organization) for the purposes of conducting research on behalf of the Company with respect to the CVR Assets shall not be deemed a CVR Transaction and (b) the sale of all or substantially all of the Companys or any of its Affiliates stock or assets (to the extent such asset sale includes assets unrelated to the CVR Assets), or a merger, acquisition or similar transaction shall not be deemed a CVR Transaction. For the avoidance of doubt, more than one CVR Transaction may occur under this Agreement.
Holder means a Person in whose name a CVR is registered in the CVR Register.
Holder Representative means the Holder Representative named in the first paragraph of this Agreement, until a successor Holder Representative has become such pursuant to the applicable provisions of this Agreement, and thereafter Holder Representative will mean such successor Holder Representative.
Intellectual Property means all intellectual property, including the following items of intangible property, and all rights associated therewith in any jurisdiction and tangible embodiments thereof: (a) all Patents; (b) all works of authorship, copyrights, whether or not registered, and all registrations and pending applications for registration of the same and renewals thereof and database rights; (c) all technology, technical information, know-how and data, including, without limitation, inventions (whether or not patentable of reduced to practice), improvements, discoveries, trade secrets, specifications, instructions, ideas, processes, methods, formulations, formulae, protocols, materials, assays, screens, algorithms, models, databases, expertise and other technology applicable to formulations, compositions or products or to their manufacture, development, registration, use or marketing or to methods of assaying or testing them or processes for their manufacture, formulations containing them or compositions incorporating or comprising them, and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, nonclinical, pre-clinical and clinical data, regulatory data and filings, instructions, processes, formulae, expertise and information, relevant to the research, development, manufacture, use, importation, offering for sale or sale of, and/or which may be useful in studying, testing, developing, producing or formulating, a Company Product, or intermediates for the synthesis thereof and chemistry, manufacturing and control information and data, lab notebooks, Patent data and records, stability, technology, test and other data and results; and (d) computer programs, including, without limitation, computer programs embodied in semiconductor chips or otherwise embodied, and related flow-charts, programmer notes, updates and data, whether in object or source code form.
Initial CVR Payment Amount means an amount equal to the greater of: (i) twenty-five percent (25%) of the Net Proceeds actually received by the Company at the closing of the first CVR Transaction to occur following the date hereof or (ii) the Target Payment Amount; provided, however, that the Company shall not be
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required to pay the Initial CVR Payment Amount unless and until the aggregate Net Proceeds from CVR Transactions equals or exceeds the Target Payment Amount.
Net Proceeds means an aggregate amount equal to the sum of: (a) all cash consideration actually received by the Company or its Affiliates from a Third Party in connection with the consummation of a CVR Transaction during the twelve (12) month period immediately following the consummation of a CVR Transaction, plus (b) with respect to any non-cash consideration actually received by the Company or its Affiliates from a Third Party in connection with the consummation of a CVR Transaction during the twelve (12) month period immediately following the consummation of a CVR Transaction, the fair market value of such non-cash consideration, as determined by the Board of Directors in good faith, less (c) all out-of-pocket transaction costs and expenses incurred by the Company or its Affiliates after the date of this Agreement to Third Parties for the negotiation, entry into and consummation of a CVR Transaction, including any broker fees, finders fees, advisory fees, accountant or attorneys fees, and reasonable costs of recovery of any amounts payable to the Company in connection with a CVR Transaction, less (d) patent prosecution and maintenance costs and drug storage costs incurred by the Company with respect to the CVR Assets after the Closing Date, less (e) any applicable sales, income and other taxes incurred by the Company or its Affiliates in respect of a CVR Transaction, and less (f) all fees and costs (including any amounts paid for indemnification) payable by the Company to the Rights Agent pursuant to this Agreement in connection with a CVR Transaction; provided, that in the event a CVR Transaction is a Combination CVR Asset Transaction, (i) the expenses in clauses (c) through (f) shall be reduced by 50% and (ii) the Net Proceeds (calculated after giving effect to this proviso) in respect of such Combination CVR Asset Transaction shall be reduced by fifty percent (50%). For the avoidance of doubt, amounts placed in escrow or earnout, contingent or other post-closing payments, including royalty payments, in connection with a CVR Transaction will not be considered Net Proceeds unless (and only to the extent that) such amounts are actually received by the Company during the twelve (12)-month period immediately following the closing of such CVR Transaction. For the further avoidance of doubt, if a CVR Transaction occurs prior to the CVR Expiration Date, any such escrow, earnout, contingent or other post-closing payment released or paid after the CVR Expiration Date will be included in the calculation of Net Proceeds, so long as such amount is actually received by the Company or its Affiliates within the twelve (12)-month period immediately following the consummation of such CVR Transaction.
Non-Achievement Certificate has the meaning set forth in Section 2.4(c).
Objection Notice has the meaning set forth in Section 2.4(d).
Objection Period has the meaning set forth in Section 2.4(d).
Officers Certificate means a certificate signed by the chief executive officer, president, chief financial officer or secretary of the Company, in his or her capacity as such an officer, and delivered to the Rights Agent and the Holder Representative.
Patents means all patents and patent applications (including provisional applications) and patent disclosures, and including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, re-issues, additions, renewals, extensions, confirmations, registrations, any confirmation patent or registration patent or patent of addition based on any such patent, patent term extensions, and supplemental protection certificates or requests for continued examinations and foreign counterparts, of any of the foregoing.
Permitted Transfer means: (i) the transfer of any or all of the CVRs (upon the death of the Holder) by will or intestacy; (ii) transfer by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death of the trustee; (iii) transfers made pursuant to a court order of a court of competent jurisdiction (such as in connection with divorce, bankruptcy or liquidation); (iv) if the Holder is a partnership or limited liability company, a pro-rata distribution by the transferring partnership or limited liability company to its partners or members, as applicable; (v) a transfer made by operation of law (including a consolidation or merger) or in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; (vi) a transfer from a participants account in a tax-qualified employee benefit plan to the participant or to such participants account in a different tax-qualified
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employee benefit plan or to a tax-qualified individual retirement account for the benefit of such participant; (vii) a transfer from a participant in a tax-qualified employee benefit plan, who received the CVRs from such participants account in such tax-qualified employee benefit plan, to such participants account in a different tax-qualified employee benefit plan or to a tax-qualified individual retirement account for the benefit of such participant; or (viii) in the case of CVRs held in book-entry form or other similar nominee form, from a nominee to a beneficial owner (and, if applicable, through an intermediary) or from such nominee to another nominee for the same beneficial owner, in each case as allowable by DTC.
Person means an individual, a corporation, a limited liability company, a partnership, an association, a trust or any other entity or organization, including a government or political subdivision or any agency or instrumentality thereof.
Record Date means [●], 2020. For the avoidance of doubt, the Record Date shall occur after the effectiveness of the Company Reverse Stock Split.
Reporting Certificate has the meaning set forth in Section 2.4(a).
Rights Agent means the Rights Agent named in the first paragraph of this Agreement, until a successor Rights Agent has become such pursuant to the applicable provisions of this Agreement, and thereafter Rights Agent will mean such successor Rights Agent.
Rights Agent Fee means the agreed-upon fee of the Rights Agent to act in such capacity pursuant to the terms of this Agreement.
STING Trial means the Companys ongoing Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation study examining SB 11285 administered as an IV infusion in patients with advanced solid tumors.
Surviving Person has the meaning set forth in Section 6.1(a)(i).
Target Payment Amount means an aggregate amount equal to the product obtained by multiplying (i) $1.00 (subject to adjustment for the Company Reverse Stock Split) by (ii) the total number of shares of Common Stock outstanding as of 5:01 p.m. Eastern Time on the Record Date; provided, that in no event will the Target Payment Amount exceed $18,000,000.
Technical Failure means (a) the good faith determination by the Board of Directors, based upon any information that becomes available or any analysis of such information at any time, that any Company Product, or any component thereof, (i) presents a material safety risk (in light of the intended patient population and the phase of dose escalation) that makes further testing of such Company Product unsafe, unwarranted or unethical, or (ii) has failed to sufficiently demonstrate the engagement of the intended or relevant biomarkers for the STING target at a given stage of dose escalation and patient tolerability (in light of the intended patient population) and further dose escalation is unlikely to result in engagement of such biomarkers at a dose level which is reasonably tolerable given the intended patent population, or (b) the receipt by the Company of any adverse decision or determination by, or correspondence from, a Governmental Body regarding any Company Product that the Board of Directors determines in good faith could reasonably be expected to render marketing approval or clearance from the FDA or the European Medicines Agency unlikely, or (c) if any of the Patents included as part of the CVR Assets that are material to the successful commercialization of the Product in the United States and the European Economic Area are held to be unenforceable, invalid or unpatentable or revoked or cancelled, in any case, by a final, nonappealable order of any court or administrative agency of competent jurisdiction.
Third Party means any Person other than the Company or the Rights Agent or their respective Affiliates.
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ARTICLE II
CONTINGENT VALUE RIGHTS
2.1 Authority; Issuance of CVRs; Appointment of Rights Agent.
(a) The Company has all requisite corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated by this Agreement. The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by all necessary corporate action on the part of the Company and no other corporate proceedings on the part of the Company are necessary to authorize this Agreement or to consummate the transactions contemplated hereby. Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby will (i) result in any violation of any provision of the Certificate of Incorporation or By-laws of the Company, or (ii) result in any violation of any loan or credit agreement, note, mortgage, indenture, lease, or other agreement, obligation, instrument, permit, concession, franchise, license, judgment, order, decree, statute, law, ordinance, rule or regulation applicable to Company or its properties or assets which violation, in the case of clause (ii), individually or in the aggregate, would reasonably be expected to be material to the Company. No consent, approval, order or authorization of, or registration, declaration or filing with, any Governmental Body is required by or with respect to the Company in connection with the execution and delivery of this Agreement by the Company or the consummation by the Company of the transactions contemplated hereby.
(b) One CVR will be issued with respect to each share of Common Stock that is outstanding as of 5:01 p.m. Eastern Time on the Record Date.
(c) The Company hereby appoints Computershare Trust Company N.A. as the Rights Agent to act as rights agent for the Company in accordance with the instructions hereinafter set forth in this Agreement, and Computershare Trust Company N.A. hereby accepts such appointment.
2.2 Nontransferable. The CVRs may not be sold, assigned, transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than through a Permitted Transfer. Any purported transfer of a CVR other than in a Permitted Transfer shall be null and void ab initio.
2.3 No Certificate; Registration; Registration of Transfer; Change of Address.
(a) The CVRs will be issued in book-entry form only and will not be evidenced by a certificate or other instrument.
(b) The Rights Agent will keep a register (the CVR Register) for the registration of the CVRs. The Rights Agent is hereby initially appointed CVR Registrar for the purpose of registering the CVRs and Permitted Transfers of the CVRs as herein provided. Upon any change in the identity of the Rights Agent, the successor Rights Agent will automatically also become the successor CVR Registrar.
(c) Subject to the restrictions on transferability set forth in Section 2.2, every request made to transfer a CVR must be in writing and accompanied by a written instrument or instruments of transfer and any other requested documentation in a form reasonably satisfactory to the Company and the CVR Registrar, duly executed by the registered Holder or Holders thereof or by the duly appointed legal representative thereof or by a duly authorized attorney, including the evidence of authority of the party presenting the CVR for transfer, which authority may include, if applicable, a signature guarantee from an eligible guarantor institution participating in a signature guarantee program approved by the Securities Transfer Association. A request for a transfer of a CVR must be accompanied by such documentation establishing that the transfer is a Permitted Transfer as may be reasonably requested by the Company and/or the CVR Registrar, if appropriate. Upon receipt of such written request and materials, the CVR Registrar will, subject to its reasonable determination that the transfer instrument is in proper form and the transfer otherwise complies with the other terms and conditions herein, register the transfer of the CVRs in the CVR Register. All duly transferred CVRs registered in the CVR Register will be the valid obligations of the Company, evidencing the same right and will entitle the transferee to the same benefits and rights under this Agreement as those previously held by the transferor. No transfer of a CVR will be valid until registered in the CVR Register, and any transfer not duly registered in the CVR Register will be void and
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invalid. All costs and expenses related to any transfer or assignment of the CVRs (including the cost of any transfer tax) will be the responsibility of the transferor.
(d) A Holder (or an authorized representative thereof) may make a request to the CVR Registrar to change such Holders address of record in the CVR Register. Upon receipt of such request, the CVR Registrar will promptly record the change of address in the CVR Register.
2.4 Payment Procedures.
(a) As soon as practicable following the occurrence of a CVR Transaction, but in no event later than thirty (30) days after the closing of such CVR Transaction, and within thirty (30) days after the end of any calendar quarter in which the Company has received Net Proceeds from any CVR Transaction, the Company will deliver to the Holder Representative and the Rights Agent a certificate (each, a Reporting Certificate), certifying that the Holders are entitled to receive a CVR Payment and setting forth the Companys calculation of the CVR Payment Amount, which may be either the Initial CVR Payment Amount or a CVR Payment Adjustment Amount.
(b) [reserved]
(c) If no CVR Transaction has been effected prior to the CVR Expiration Date, then, as soon as reasonably practicable after the CVR Expiration Date, but in no event later than thirty (30) days after the CVR Expiration Date, the Company will deliver to the Holder Representative and the Rights Agent a certificate (the Non-Achievement Certificate and, together with the Reporting Certificate(s), the Certificates), stating that no CVR Transaction has been consummated prior to the CVR Expiration Date.
(d) If the Holder Representative does not object to any determination or calculation set forth in a Certificate by delivery of a written notice thereof to the Company setting forth in reasonable detail such objection, together with reasonable supporting documentation (an Objection Notice), within thirty (30) days following receipt of the applicable Certificate (the Objection Period), the Companys determination of the non-existence of a CVR Transaction, calculation of the Initial CVR Payment Amount or calculation of any CVR Payment Adjustment Amount, as applicable, shall be final and binding on all parties. If the Holder Representative timely delivers to the Company an Objection Notice, the Company and the Holder Representative shall attempt in good faith to resolve such matters within thirty (30) days after receipt of the same by the Company, and if unable to do so, the Company and the Holder Representative shall resolve any unresolved disputed in accordance with Section 8.11, which decision will be final and binding on the parties, absent manifest error. The Company shall, within ten (10) Business Days following the final determination of the Initial CVR Payment Amount or any CVR Payment Adjustment Amount, as applicable, pay such Initial CVR Payment Amount or CVR Payment Adjustment Amount to the Rights Agent (for the account of the Holders) by wire transfer of immediately available funds to such account as may be designated by the Rights Agent. The Rights Agent will distribute the Initial CVR Payment Amount or CVR Payment Adjustment Amount, as applicable, to the Holders (each Holder being entitled to receive its pro rata share of such Initial CVR Payment Amount or CVR Payment Adjustment Amount, as applicable, based on the number of CVRs held by such Holder as reflected on the CVR Register on the date of the Reporting Certificate or the date of final determination pursuant to this Agreement, as applicable) (i) by check mailed to the address of each such respective Holder as reflected in the CVR Register as of the close of business on the last Business Day before such CVR Payment Date, or, (ii) with respect to any Holder who has provided the Rights Agent with wire transfer instructions meeting the Rights Agents requirements, by wire transfer of immediately available funds to such account.
(e) If an Objection Notice has not been timely delivered to the Company in response to a Non-Achievement Certificate within the Objection Period, then the Holders will have no right to receive a CVR Payment, and the Company and the Rights Agent will have no further obligations with respect to any CVR Payment.
(f) The Company will be entitled to deduct and withhold, or cause to be deducted or withheld, from any Initial CVR Payment Amount, CVR Payment Adjustment Amount or other amount payable pursuant to this Agreement, such amounts as the Company is required to deduct and withhold with respect to the making of such
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payment under the Internal Revenue Code, or any provision of state or local tax law. To the extent that amounts are so withheld or paid over to or deposited with the relevant governmental entity, such withheld amounts will be treated for all purposes of this Agreement as having been paid to the Holder in respect of which such deduction and withholding was made.
(g) Subject to prior execution and delivery by the Holder Representative of a reasonable and customary confidentiality and market stand-off agreement, the Company shall provide the Holder Representative with reasonable access during normal business hours and upon reasonable advance request to the books and records of the Company to the extent necessary to verify whether a CVR Transaction occurred prior to the CVR Expiration Date or the Companys calculation of the Initial CVR Payment Amount or any CVR Payment Adjustment Amount, as applicable; it being understood that the Holder Representatives rights under this Section 2.4(g) shall terminate upon the later of (i) the CVR Expiration Date or (ii) thirty (30) days after the delivery to the Holder Representative of a Reporting Certificate.
(h) The Company will promptly furnish to the Rights Agent all information and documentation in connection with this Agreement and the CVRs that the Rights Agent may reasonably request in order to perform under this Agreement.
(i) The Company acknowledges that the bank accounts maintained by the Rights Agent in connection with the services provided under this Agreement will be in the Rights Agents name and that the Rights Agent may receive investment earnings in connection with the investment at the Rights Agents risk and for its benefit of funds held in those accounts from time to time.
2.5 No Voting, Dividends or Interest; No Equity or Ownership Interest in the Company.
(a) The CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable on the CVRs to any Holder.
(b) The CVRs will not represent any equity or ownership interest in the Company. The rights of the Holders and the obligations of the Company are contract rights limited to those expressly set forth in this Agreement, and such Holders sole right to receive property hereunder is the right to receive cash from the Company, if any, through the Rights Agent in accordance with the terms hereof. It is hereby acknowledged and agreed that a CVR shall not constitute a security of the Company.
2.6 Holders Right to Abandon CVR. A Holder may at any time, at such Holders option, abandon all of such Holders remaining rights in a CVR by transferring such CVR to the Company or any of its Affiliates without consideration. Nothing in this Agreement shall prohibit the Company or its Affiliates from offering to acquire or acquiring CVRs, in private transactions or otherwise, in its sole discretion. Any CVRs acquired by the Company or any of its Affiliates shall be automatically deemed extinguished and no longer outstanding hereunder for any purpose.
ARTICLE III
THE RIGHTS AGENT
3.1 Certain Duties and Responsibilities.
(a) The Rights Agent will not have any liability for any actions taken or not taken in connection with this Agreement, except to the extent of its willful misconduct, bad faith or gross negligence. No provision of this Agreement will require the Rights Agent to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of any of its rights or powers. Notwithstanding anything contained herein to the contrary, the Rights Agents aggregate liability under this Agreement, or from all services provided or omitted to be provided under this Agreement, whether in contract, or in tort, or otherwise, is limited to, and shall not exceed, the amounts paid hereunder by the Company to the Rights Agent as fees and charges, but not including reimbursable expenses.
(b) The Holder Representative may direct the Rights Agent to act on behalf of the Holders in enforcing any of its or their rights hereunder, including the delivery of any Objection Notice and negotiation or arbitration
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pursuant to Section 8.11; provided, however, the Rights Agent may not act on behalf of the Holders or the Holder Representative in any dispute relating to or arising under Section 4.3 or relating to whether a CVR Transaction has occurred or the amount of any CVR Payment. The Rights Agent will be under no obligation to institute any action, suit or legal proceeding or to take any other action likely to involve material expense unless the Holder Representative will furnish the Rights Agent with reasonable security and indemnity for any costs and expenses that may be incurred. All rights of action under this Agreement may be enforced by the Rights Agent, and any action, suit or proceeding instituted by the Rights Agent on behalf of the Holders will be brought in its name as Rights Agent, and any recovery of judgment will be for the ratable benefit of all the Holders, as their respective rights or interests may appear.
3.2 Certain Rights of Rights Agent. The Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied covenants or obligations will be read into this Agreement against the Rights Agent. In addition:
(a) the Rights Agent may rely and will be protected in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document reasonably believed by it to be genuine and to have been signed or presented by the proper party or parties;
(b) whenever the Rights Agent will deem it desirable that a matter be proved or established before taking, suffering or omitting any action hereunder, the Rights Agent may, in the absence of willful misconduct, bad faith or gross negligence on its part, rely upon an Officers Certificate;
(c) the Rights Agent may engage and consult with counsel of its selection and the written advice of such counsel or any opinion of counsel will be full and complete authorization and protection in respect of any action taken, suffered or omitted by it hereunder in good faith and in reliance thereon;
(d) in the event of arbitration, the Rights Agent may engage and consult with tax experts, valuation firms and other experts and third parties that it, in its sole and absolute discretion, deems appropriate or necessary to enable it to discharge its duties hereunder;
(e) the permissive rights of the Rights Agent to do things enumerated in this Agreement will not be construed as a duty;
(f) the Rights Agent will not be required to give any note or surety in respect of the execution of such powers or otherwise in respect of the premises;
(g) the Company agrees to indemnify the Rights Agent for, and hold the Rights Agent harmless against, any loss, liability, claim, demands, suits or expense (in each case pertaining to the Rights Agents own account only) arising out of or in connection with the Rights Agents duties under this Agreement, including the costs and expenses of defending the Rights Agent against any claims, charges, demands, suits or loss, unless such loss has been determined by a court of competent jurisdiction to be a result of the Rights Agents willful misconduct, bad faith or gross negligence; and
(h) the Company agrees (i) to pay the fees and expenses of the Rights Agent in connection with this Agreement, as set forth on Schedule 1 hereto, and (ii) to reimburse the Rights Agent for all taxes and governmental charges, reasonable expenses and other charges of any kind and nature incurred by the Rights Agent in the execution of this Agreement (other than taxes imposed on or measured by the Rights Agents net income and franchise or similar taxes imposed on it). The Rights Agent will also be entitled to reimbursement from the Company for all reasonable and necessary out-of-pocket expenses (including reasonable fees and expenses of the Rights Agents counsel and agent) paid or incurred by it in connection with the administration by the Rights Agent of its duties hereunder. An invoice for the Rights Agent Fee will be rendered a reasonable time before, and paid on, the effective date of the applicable transaction. An invoice for any out-of-pocket expenses and per item fees realized will be rendered and payable within thirty (30) days after receipt by the Company. The Company agrees to pay to Rights Agent any amounts, including fees and expenses, payable in favor of the Rights Agent in connection with any dispute, resolution or arbitration arising under or in connection with the
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Agreement; and any fees and expenses, payable by the Company in favor of the Rights Agent or payable in favor of the Company related to such dispute, resolution or arbitration will be offset against any CVR Payments, if any, or any other payment to be made thereafter under this Agreement.
3.3 Resignation and Removal; Appointment of Successor.
(a) The Rights Agent may resign at any time by giving written notice thereof to the Company, specifying a date when such resignation will take effect, which notice will be sent at least thirty (30) days before the date so specified.
(b) If the Rights Agent provides notice of its intent to resign, is removed or becomes incapable of acting, the Company, by way of a Board Resolution, will as soon as practicable appoint a qualified successor Rights Agent who, unless otherwise consented to in writing by the Holder Representative, shall be a stock transfer agent of national reputation or the corporate trust department of a commercial bank. The successor Rights Agent so appointed will, forthwith upon its acceptance of such appointment in accordance with Section 3.4, become the successor Rights Agent.
(c) The Company will give notice of each resignation and each removal of a Rights Agent and each appointment of a successor Rights Agent by mailing written notice of such event by first-class mail, postage prepaid, to the Holders as their names and addresses appear in the CVR Register and by delivering notice to the Holder Representative. Each notice will include the name and address of the successor Rights Agent. If the Company fails to send such notice within five (5) Business Days after acceptance of appointment by a successor Rights Agent, upon the Companys request the successor Rights Agent will cause such notice to be mailed at the expense of the Company.
3.4 Acceptance of Appointment by Successor. Every successor Rights Agent appointed hereunder will execute, acknowledge and deliver to the Company and to the retiring Rights Agent an instrument accepting such appointment and a counterpart of this Agreement, and thereupon such successor Rights Agent, without any further act, deed or conveyance, will become vested with all the rights, powers, trusts and duties of the retiring Rights Agent; provided, however, that upon the request of the Company or the successor Rights Agent, such retiring Rights Agent will cooperate in the transfer of all relevant data, including the CVR Register, to the successor Rights Agent.
ARTICLE IV
COVENANTS
4.1 List of Holders. The Company will furnish or cause to be furnished to the Holder Representative and the Rights Agent the names, addresses and shareholdings of registered holders of Common Stock as of 5:01 p.m. Eastern Time on the Record Date. The Company will promptly furnish an electronic copy of the CVR Register to the Holder Representative upon written request from the Holder Representative.
4.2 [RESERVED]
4.3 Diligence.
(a) From and after the Closing, until the CVR Expiration Date, the Company shall use Commercially Reasonable Efforts to (i) complete the STING Trial and (ii) pursue CVR Transactions. Subject to the preceding sentence, the Company has no obligation to develop or expend any funds in connection with the development of any Company Product (except to the extent provided in the immediately following sentence) and has no obligation to license, sell or otherwise monetize any Company Product. The Companys obligations pursuant to the first sentence of this Section 4.3(a) will expire (x) with respect to clause (i) thereof, upon the earlier to occur of: (A) a Technical Failure, or (B) the date on which the Company and its Affiliates have incurred at least $1,812,000 in aggregate out-of-pocket costs and expenses in connection with the conduct of the STING Trial; and (y) with respect to clause (ii) thereof, in respect of a Company Product, upon the occurrence of a Technical Failure with respect to such Company Product.
(b) Notwithstanding the foregoing, the obligation of the Company to use Commercially Reasonable Efforts pursuant to Section 4.3(a) shall not be deemed a guarantee that any CVR Payment will be earned. Neither
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the Company nor any of its directors, officers or their respective Affiliates owes any fiduciary duty to the Holders with respect to the CVR Payments. Further, the parties acknowledge that the Companys sole obligations with respect to any potential CVR Payments are expressly set forth in this Agreement.
ARTICLE V
AMENDMENTS
5.1 Amendments Without Consent of Holder Representative.
(a) Without the consent of the Holder Representative or the Rights Agent, the Company, when authorized by a Board Resolution, at any time and from time to time, may enter into one or more amendments hereto, for any of the following purposes:
(i) to evidence the succession of another Person to the Company and the assumption by any such successor of the covenants of the Company herein in a transaction contemplated by Section 6.1 hereof; or
(ii) to evidence the termination of the CVR Registrar and the succession of another Person as a successor CVR Registrar and the assumption by any successor of the obligations of the CVR Registrar herein.
(b) Without the consent of the Holder Representative, the Company, when authorized by a Board Resolution, together with the Rights Agent, in the Rights Agents sole and absolute discretion, may at any time and from time to time, enter into one or more amendments hereto:
(i) to evidence the succession of another Person as a successor Rights Agent and the assumption by any successor of the covenants and obligations of the Rights Agent herein;
(ii) to add to the covenants of the Company such further covenants, restrictions, conditions or provisions as the Board of Directors and the Rights Agent will consider to be for the protection of the Holders;
(iii) to cure any ambiguity, to correct or supplement any provision herein that may be defective or inconsistent with any other provision herein; provided, however, that in each case, such provisions will not materially adversely affect the interests of the Holders;
(iv) as may be necessary to ensure that the CVRs are not subject to registration under the Securities Act of 1933, as amended, or the Exchange Act of 1934, as amended; or
(v) to add, eliminate or change any provision of this Agreement unless such addition, elimination or change is adverse to the interests of the Holders.
(c) Promptly after the execution by the Company and the Rights Agent of any amendment pursuant to the provisions of this Section 5.1, the Company will deliver a notice thereof to the Holder Representative, setting forth in general terms the substance of such amendment.
5.2 Amendments with Consent of Holder Representative. Subject to Section 5.1 (which amendments pursuant to Section 5.1 may be made without the consent of the Holder Representative), the Company, when authorized by a Board Resolution, and the Rights Agent and the Holder Representative may enter into one or more amendments hereto for the purpose of adding, eliminating or changing any or all provisions of this Agreement.
5.3 Execution of Amendments. In executing any amendment permitted by this Article V, the Rights Agent will be entitled to receive, and will be fully protected in relying upon, an opinion of counsel of the Company, at Companys sole expense, stating that the execution of such amendment is authorized or permitted by this Agreement. The Rights Agent may, but is not obligated to, enter into any such amendment that affects the Rights Agents own rights, privileges, covenants or duties under this Agreement or otherwise.
5.4 Effect of Amendments. Upon the execution of any amendment under this Article V, this Agreement will be modified in accordance therewith, such amendment will form a part of this Agreement for all purposes and every Holder will be bound thereby.
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ARTICLE VI
CONSOLIDATION, MERGER, SALE OR CONVEYANCE
6.1 Effect of Merger or Consolidation.
(a) Except as contemplated by the Acquisition, the Company will not consolidate with or merge into any other Person or sell, transfer or otherwise convey all or substantially all of its assets, in one or a series of related transactions, to any Person, unless:
(i) the Person formed by such consolidation or into which the Company is merged or the Person that acquires by sale, transfer or other conveyance, all or substantially all of the assets of the Company (the Surviving Person) expressly assumes payment (if and to the extent required hereunder) of amounts on all the CVRs and the performance of every duty and covenant of this Agreement on the part of the Company to be performed or observed; and
(ii) the Company has delivered to the Holder Representative and the Rights Agent an Officers Certificate, stating that such consolidation, merger, conveyance, transfer or lease complies with this Article VI and that all conditions precedent herein provided for relating to such transaction have been complied with.
(b) In connection with a Change of Control, the Company will have the right, but not the obligation, in its sole discretion, to redeem all, but not less than all of the outstanding CVRs, at any time from and after the public announcement of such Change of Control and ending on the thirtieth (30th) day following the consummation of the Change of Control for an aggregate redemption amount equal to the Target Payment Amount. In the event that the Company wishes to exercise its right pursuant to this Section 6.1(b), the Company shall provide a written notice of redemption (a Redemption Notice) to the Rights Agent and the Holder Representative, which Redemption Notice shall specify the date fixed for the redemption of the outstanding CVRs, which date shall be not less than five (5) Business Days nor more than ten (10) Business Days following the delivery of the Redemption Notice to the Rights Agent and the Holder Representative (such date, the Redemption Date). Promptly following its receipt of the Redemption Notice, the Rights Agent shall deliver a copy thereof to the Holders. On the Redemption Date, the Company shall pay the Target Payment Amount to the Rights Agent (for the account of the Holders) by wire transfer of immediately available funds to such account as may be designated by the Rights Agent. Upon the indefeasible payment in full by the Company of the Target Payment Amount to the Rights Agent, the CVRs shall be cancelled and of no further force and effect and shall thereafter represent only the right to receive such Holders pro rata share of the Target Payment Amount upon surrender of such Holders CVR to the Rights Agent. The Rights Agent shall pay to each Holder, such Holders pro rata share of the Target Payment Amount pursuant to the payment procedures specified in Section 2.4(d) and subject to Section 2.4(f) upon surrender by such Holder of its CVR for cancellation or receipt of an appropriate affidavit of loss or destruction thereof.
6.2 Successor Substituted. Upon any consolidation of or merger by the Company with or into any other Person, or any conveyance, transfer or lease of the properties and assets substantially as an entirety to any Person in accordance with Section 6.1, the Surviving Person will succeed to, and be substituted for, and may exercise every right and power of, the Company under this Agreement with the same effect as if the Surviving Person had been named as the Company herein, and thereafter the predecessor Person will be relieved of all obligations and covenants under this Agreement and the CVRs.
ARTICLE VII
THE HOLDER REPRESENTATIVE
7.1 Appointment. Effective upon the issuance of the CVRs under this terms of this Agreement, and without any further act of any of Holders, the Holder Representative is appointed as the representative of the Holders and as the attorney-in-fact and agent for and on behalf of each Holder for purposes of this Agreement and will take such actions to be taken by the Holder Representative under this Agreement and such other actions on behalf of such Holders as it may deem necessary or appropriate in connection with or to consummate the transactions contemplated hereby, including (i) executing and delivering this Agreement and any other ancillary documents
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and negotiating and executing any amendments, modifications, waivers or changes thereto as to which the Holder Representative, in its sole discretion, has consented (provided that any waiver or amendment that adversely and disproportionately affects the rights or obligations of one or more Holders as compared to other Holders will require the prior written consent of a majority in interest of the disproportionately affected Holders), (ii) agreeing to, negotiating, entering into settlements and compromises of, complying with orders of courts with respect to, and otherwise administering and handling any claims under this Agreement on behalf of such Holders, and (iii) taking all other actions that are either necessary or appropriate in the judgment of the Holder Representative for the accomplishment of the foregoing or contemplated by the terms of this Agreement. The Holder Representative hereby accepts such appointment and agrees to serve as such without compensation. The appointment of the Holder Representative as each Holders attorney-in-fact revokes any power of attorney heretofore granted that authorized any other Person to represent such Holder with regard to this Agreement and any other agreements or documents executed or delivered in connection with this Agreement. The Holder Representative is the sole and exclusive representative of each of the Holders for any purpose provided for by this Agreement.
7.2 Actions of Holder Representative.
(a) A decision, act, consent or instruction of the Holder Representative hereunder will constitute a decision, act, consent or instruction of all Holders and will be final, binding and conclusive upon each such Holder, and the Company and the Rights Agent may rely upon any such decision, act, consent or instruction of the Holder Representative as being the decision, act, consent or instruction of each and every such Holder. The Company and the Rights Agent will be relieved from any liability to any Person for any acts done by them in accordance with such decision, act, consent or instruction of the Holder Representative.
(b) The Holder Representative will incur no liability with respect to any action taken or suffered by any Holder in reliance upon any notice, direction, instruction, consent, statement or other document believed by such Holder Representative to be genuine and to have been signed by such Holder (and will have no responsibility to determine the authenticity thereof), nor for any other action or inaction, except the gross negligence, bad faith or willful misconduct of the Holder Representative. In all questions arising under this Agreement, the Holder Representative may rely on the advice of outside counsel, and the Holder Representative will not be liable to any Holder for anything done, omitted or suffered in good faith by Holder Representative based on such advice.
(c) The Holders will severally (on a pro rata basis, based on the number of CVRs held by each Holder), but not jointly, indemnify the Holder Representative and hold the Holder Representative harmless against any loss, liability or expense incurred without gross negligence, bad faith or willful misconduct on the part of the Holder Representative and arising out of or in connection with the acceptance or administration of the Holder Representatives duties hereunder, including the reasonable fees and expenses of any legal counsel or other advisors reasonably retained by the Holder Representative, to the extent not reimbursed by the Company pursuant to Section 7.2(d).
(d) In connection with providing services under this Agreement, the Holder Representative will be reimbursed by the Company for all reasonable fees and expenses incurred in providing such services. Any such fees and expenses will be paid by the Company within thirty (30) days of the receipt of an invoice from the Holder Representative and will be offset against the CVR Payment Amount, if any.
7.3 Removal; Appointment of Successor.
(a) At any time Holders representing at least a majority of the outstanding CVRs may, by written consent, appoint another Person as Holder Representative. Notice, together with a copy of the written consent appointing such Person and bearing the signatures of Holders of at least a majority of the outstanding CVRs, must be delivered to the Company and the Rights Agent. Such appointment will be effective upon the later of the date indicated in the consent or the date ten (10) days after such consent is received by the Company and the Rights Agent.
(b) If the Holder Representative becomes unable or unwilling to continue in his or its capacity as the Holder Representative, or if the Holder Representative resigns as a Holder Representative, the Holder
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Representative may appoint a new representative as the Holder Representative. If the Holder Representative is unable or unwilling to appoint a successor Holder Representative, then the board of directors of the Company shall appoint another Person as Holder Representative. Notice and a copy of the written consent appointing such Person must be delivered to the Company and the Rights Agent not less than ten (10) days prior to such appointment. Such appointment will be effective upon the later of the date indicated in the consent or the date ten (10) days after such consent is received by the Company and the Rights Agent.
7.4 Grant of Authority. The grant of authority provided for in this Article VII is coupled with an interest and will be irrevocable and survive the death, incompetency, bankruptcy or liquidation of any Holder. The provisions of this Article VII will be binding upon the executors, heirs, legal representatives, successors and assigns of each Holder, and any references in this Agreement to any Holder or the Holders will mean and include the successors to such Holders rights hereunder, whether pursuant to testamentary disposition, the laws of descent and distribution or otherwise.
ARTICLE VIII
OTHER PROVISIONS OF GENERAL APPLICATION
8.1 Notices to Rights Agent, Company and Holder Representative. Subject to Section 8.2, all notices, requests, demands, claims and other communications that are required to be or may be given under this Agreement must be in writing and will be deemed to have been effectively given: (a) upon personal delivery to the recipient; (b) when sent by e-mail transmission, if sent during normal business hours of the recipient; if not, then on the next Business Day; or (c) one Business Day after deposit with a nationally recognized overnight courier, specifying next-day delivery, with written verification of receipt, in each case to the intended recipient at the following addresses:
(a) if to the Company, to
[●]
with a copy (which shall not constitute notice) to:
[●];
(b) if to the Rights Agent, to
[●]
with a copy (which shall not constitute notice) to:
[●]; and
(c) if to the Holder Representative, to
[●]
with a copy (which shall not constitute notice) to:
[●]
or to such other address as any party has furnished to the other parties by notice given in accordance with this Section 8.1.
8.2 Notice to Holders. Where this Agreement provides for notice to Holders, such notice will be sufficiently given (unless otherwise herein expressly provided) if in writing and mailed, first-class postage prepaid, to each Holder affected by such event, at his, her or its address as it appears in the CVR Register, not later than the latest date, and not earlier than the earliest date, prescribed for the giving of such notice. In any case where notice to Holders is given by mail, neither the failure to mail such notice, nor any defect in any notice so mailed, to any particular Holder will affect the sufficiency of such notice with respect to other Holders.
8.3 Entire Agreement. This Agreement represents the entire understanding of the parties hereto with reference to the CVRs and this Agreement supersedes any and all other oral or written agreements made with respect to the CVRs. No party has relied on any other express or implied representation or warranty, either written or oral in connection with its entry into this Agreement, including any representation or warranty arising under statute or otherwise under law.
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8.4 Legal Holidays. If a CVR Payment Date is not a Business Day, then, notwithstanding any provision of this Agreement to the contrary, any payment required to be made in respect of the CVRs on such date need not be made on such date, but may be made on the next succeeding Business Day with the same force and effect as if made on the CVR Payment Date.
8.5 Assignment. The Company may not assign this Agreement without the prior written consent of the Holder Representative; provided that the Company may assign, in its sole discretion and without the consent of any other party, any or all of its rights, interests and obligations hereunder to one or more direct or indirect wholly-owned subsidiaries of the Company (each, an Assignee) provided that the Assignee agrees to assume and be bound by all of the terms of this Agreement; provided, however, that in connection with any assignment to an Assignee, the Company shall, and shall agree to, remain liable for the performance by such Assignee of all obligations of the Company hereunder.
8.6 Third Party Beneficiaries. This Agreement will be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns. Nothing in this Agreement, express or implied, will give to any Person (other than the parties hereto, the Holders and their permitted successors and assigns hereunder) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any covenant or provision herein contained, all such covenants and provisions being for the sole benefit of the parties hereto, the Holders and their permitted successors and assigns.
8.7 Termination. This Agreement will terminate and be of no further force or effect, and the parties hereto will have no liability hereunder, upon the earliest to occur of: (a) the payment of the last possible CVR Payment due hereunder, (b) if an Objection Notice to a Non-Achievement Certificate is not delivered within the Objection Period, the expiration of the Objection Period, (c) in the event of the delivery of an Objection Notice, either (i) the final determination in accordance with this Agreement that no CVR Transaction has been achieved or (ii) the fulfillment of any payment obligation required pursuant to a final determination made in accordance with this Agreement.
8.8 Survival. Notwithstanding anything in this Agreement to the contrary, all provisions regarding indemnification, warranty, liability and limits thereon, and confidentiality shall survive the termination or expiration of this Agreement.
8.9 Governing Law. This Agreement and the CVRs will be governed by, and construed in accordance with, the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws thereof.
8.10 Remedies. The Holders will not have any rights or remedies with respect to the CVRs except as expressly set forth herein.
8.11 Disputes.
(a) Before any arbitration pursuant to Section 8.11(b), the Company, the Rights Agent and the Holder Representative will negotiate in good faith for a period of thirty (30) days to resolve any controversy or claim arising out of or relating to this Agreement or the breach thereof.
(b) Any and all disputes arising under this Agreement (including but not limited to any claims brought by the Holder Representative on behalf of the Holders) shall be settled by final and binding arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules, except as modified herein. Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. In any arbitration under this Section 8.11(b), the number of arbitrators will be one, and such arbitrator will be selected in accordance with the AAAs Commercial Arbitration Rules. The place of the arbitration will be [●]. The arbitrator will be a lawyer or retired judge with experience in the biopharmaceutical industry and with mergers and acquisitions. Each party will, upon written request of the other party, promptly provide the other with copies of all relevant documents. There shall be no other discovery allowed. In making determinations regarding the scope of exchange of electronic information, the arbitrator and the parties agree to be guided by The Sedona Principles, Third Edition: Best Practices, Recommendations & Principles for Addressing Electronic Document Production. Time is of the essence for any arbitration under this Agreement and
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arbitration hearings shall take place within 90 days of filing and awards rendered within 120 days. The hearing shall not last longer than two days, with each hearing day lasting no longer than eight (8) hours. The arbitrator shall agree to these limits prior to accepting appointment. Except as may be required by law, neither a party nor the arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of the other parties (provided that the Holder Representative may disclose to the Holders any such information without the consent of the Company). The fees and expenses of the arbitration, including the costs and expenses billed by the arbitrator in connection with the performance of its duties described herein, will be paid by the non-prevailing party, as determined by the arbitrator, in proportion with the extent to which the prevailing party prevails, and the remainder of such costs and expenses will be paid by the prevailing party; provided, however, that any fees and expenses of the arbitration incurred by the Holder Representative shall be offset against any CVR Payment Amount, if any. Each party will be responsible for its own attorney fees, expenses and costs of investigation provided, however, that any such fees, expenses and costs incurred by the Holder Representative shall be offset against any CVR Payment Amount, if any.
8.12 Confidentiality.
(a) Confidential Information shall mean any and all technical, scientific or business information relating to a party, including, without limitation, financial, marketing and product development information, stockholder information (including any non-public information of such stockholder), and proprietary information that is disclosed or otherwise becomes known to the other party or its Affiliates, agents or representatives before or during the term of this Agreement. Confidential Information constitutes trade secrets and is of great value to the owner (or its Affiliates). Confidential Information shall not include any information that is: (a) already known to the other party or its Affiliates at the time of the disclosure, provided that such prior knowledge can be substantiated by the written records of such party; (b) publicly known at the time of the disclosure or becomes publicly known through no wrongful act or failure of the other party; (c) subsequently disclosed to the other party or its Affiliates on a non-confidential basis by a third party not having a confidential relationship with the owner and which rightfully acquired such information; or (d) independently developed by one party without access to the Confidential Information of the other, provided that such independent development can be substantiated by the written records of such party. This Agreement, including all of its terms and conditions, will not be deemed to be Confidential Information and may be publicly disclosed by the Company.
(b) All Confidential Information of a party will be held in confidence by the other party with at least the same degree of care as such party protects its own confidential or proprietary information of like kind and import, but not less than a reasonable degree of care. Neither party will disclose in any manner Confidential Information of the other party in any form to any person or entity without the other partys prior consent. However, each party may disclose relevant aspects of the other partys Confidential Information to its officers, Affiliates, agents, subcontractors and employees to the extent reasonably necessary to perform its duties and obligations under this Agreement. Without limiting the foregoing, each party will implement such physical and other security measures and controls as are necessary to protect (a) the security and confidentiality of Confidential Information; (b) against any threats or hazards to the security and integrity of Confidential Information; and (c) against any unauthorized access to or use of Confidential Information. To the extent that a party delegates any duties and responsibilities under this Agreement to an agent or other subcontractor, the party ensures that such agent and subcontractor are contractually bound to confidentiality terms consistent with the terms of this Section 8.13.
(c) In the event that any requests or demands are made for the disclosure of Confidential Information, other than requests to Rights Agent for stockholder records pursuant to standard subpoenas from state or federal government authorities (e.g., divorce and criminal actions), the party receiving such request will promptly notify the other party to secure instructions from an authorized officer of such party as to such request and to enable the other party the opportunity to obtain a protective order or other confidential treatment, unless such notification is otherwise prohibited by law or court order. Each party expressly reserves the right, however, to disclose Confidential Information to any person whenever it is advised by counsel that it may be held liable for the failure to disclose such Confidential Information or if required by law or court order.
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(d) As may be required by law and without limiting any partys rights in respect of a breach of this Section 8.12, each party will promptly:
(i) notify the other party in writing of any unauthorized possession, use or disclosure of the other partys Confidential Information by any person or entity that may become known to such party;
(ii) furnish to the other party full details of the unauthorized possession, use or disclosure; and
(iii) use commercially reasonable efforts to prevent a recurrence of any such unauthorized possession, use or disclosure of Confidential Information.
8.13 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. Delivery of a signed Agreement by reliable electronic means, including facsimile, email, or any electronic signature complying with the U.S. federal ESIGN Act of 2000 (including DocuSign) shall be an effective method of delivering the executed Agreement. This Agreement may be stored by electronic means and either an original or an electronically stored copy of this Agreement can be used for all purposes, including in any proceeding to enforce the rights and/or obligations of the parties to this Agreement.
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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf by its duly authorized officers as of the day and year first above written.
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[●] | ||
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Title: |
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F-STAR: |
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[●] | ||
By: |
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Title: |
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RIGHTS AGENT: |
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[●] |
By: |
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Title: |
HOLDER REPRESENTATIVE:
[●]
By: |
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Schedule 1
Rights Agent Fees
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EXHIBIT E-2
FORM OF STING ANTAGONIST CONTINGENT VALUE RIGHTS AGREEMENT
STING ANTAGONIST CONTINGENT VALUE RIGHTS AGREEMENT
THIS STING ANTAGONIST CONTINGENT VALUE RIGHTS AGREEMENT, dated as of [], 2020 (this Agreement), is entered into by and among Spring Bank Pharmaceuticals, Inc., a Delaware corporation (the Company), F-Star Therapeutics Limited, a company registered in England and Wales with company number 11532458 (F-Star), Computershare Trust Company N.A. (the Rights Agent) and initial CVR Registrar (as defined herein), and [], acting solely in his capacity as representative of the Holders (as defined herein) (the Holder Representative). Capitalized terms not defined herein shall have the meanings ascribed to them in the Share Exchange Agreement (as defined below).
A. The Company, F-Star, and certain other Persons (the Sellers) have entered into a Share Exchange Agreement (the Share Exchange Agreement), pursuant to which the Sellers will sell to the Company, and the Company will purchase from the Sellers, all of the F-Star Shares (the Acquisition).
B. Pursuant to Section 1.7 of the Share Exchange Agreement, prior to the consummation of the Acquisition, the Company wishes to create and issue contractual contingent value rights relating to the CVR Assets (as defined herein) to the record holders of the Common Stock (as defined herein) as of a record date prior to the consummation of the Acquisition.
C. On [●], 2020, the Board of Directors of the Company authorized and declared a dividend of one CVR (as defined herein) for each share of Common Stock outstanding at 5:01 p.m. Eastern Time on the Record Date (as defined herein). The payment of such dividend will be conditioned upon, and such dividend will only become payable upon, the satisfaction or waiver of all conditions to the Acquisition and the occurrence of the time that is immediately prior to the consummation of the Acquisition. The Company will pay the dividend immediately prior to the consummation of the Acquisition.
Accordingly, and in consideration of the premises and the consummation of the transactions referred to above, it is mutually agreed, for the benefit of the Holders, as follows:
ARTICLE IX
DEFINITIONS
9.1 Definitions.
(a) For all purposes of this Agreement, except as otherwise expressly provided or unless the context otherwise requires:
(i) all accounting terms used herein and not expressly defined herein have the meanings assigned to such terms in accordance with United States generally accepted accounting principles, as in effect on the date hereof;
(ii) unless the context otherwise requires, words describing the singular number include the plural and vice versa, words denoting any gender include all genders and words denoting natural Persons include corporations, partnerships and other Persons and vice versa;
(iii) the words include and including and variations thereof will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words without limitation;
(iv) the terms hereof, hereunder, herein and words of similar import refer to this Agreement as a whole and not to any particular Article, Section or provision of this Agreement; and
(v) the Article and Section headings contained in this Agreement are for reference purposes only and do not limit or otherwise affect any of the substance of this Agreement.
(b) The following terms have the meanings ascribed to them as follows:
Affiliates means, with respect to any Person, any other Person which directly or indirectly controls, is controlled by or is under common control with such first Person.
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Approved Development Agreement means a definitive agreement entered into by Company for the Approved Development Transaction.
Approved Development Transaction means the proposed transaction relating to Companys STING (STimulator of INterferon Genes) antagonist program contemplated by the Term Sheet.
Board of Directors means the board of directors of the Company.
Board Resolution means a copy of a resolution certified by the secretary or an assistant secretary of the Company to have been duly adopted by the Board of Directors and to be in full force and effect on the date of such certification, and delivered to the Rights Agent and the Holder Representative.
Budgeted Amount means the aggregate amount of expenditures by the Company set forth in the Work Plan(s) (as defined in the Approved Development Agreement), which amount shall be the amount specified in the Term Sheet.
Business Day means a day other than a Saturday, Sunday or other day on which commercial banks located in Boston, Massachusetts or London, England are authorized or required by applicable Legal Requirements to close; provided, however, for clarification, commercial banks shall not be deemed to be authorized or required by applicable Legal Requirements to close due to stay at home, shelter-in-place, non-essential employee or any other similar orders or restrictions or the closure of any physical branch locations at the direction of any Governmental Body so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in such location generally are open for use by customers on such day.
Close of Business on any given date means 5:00 p.m., Eastern Time, on such date; provided, however, that if such date is not a Business Day it will mean 5:00 p.m., Eastern Time, on the next succeeding Business Day.
Commercially Reasonable Efforts means, with respect to the efforts and resources to be expended by the Company with respect to (i) negotiation and execution of the Approved Development Agreement (to the extent not executed and delivered prior to Closing), (ii) performing the Approved Development Transaction in accordance with the terms of the Approved Development Agreement, and (iii) pursuing and seeking to consummate CVR Transactions, such reasonable, good faith efforts and resources as a biotechnology company of a similar size and with similar financial and other resources would normally use to pursue its clinical development programs and pursue and seek to consummate such a transaction under similar circumstance for a similar product or product candidate owned by it, or to which it has similar rights, which product or product candidate is at a similar stage in its development and is of similar market potential taking into account all relevant factors; provided that, it is expressly understood and agreed that despite the use of such above described efforts, neither the Approved Development Transaction nor any CVR Transaction may occur and the obligation to make a CVR Payment may not arise.
Common Stock means the common stock, $0.0001 par value, of the Company.
Company Product means any product that incorporates any proprietary STimulator of INterferon Genes (STING) antagonist compound of the Company.
CVR means a contingent value right issued by the Company pursuant to this Agreement.
CVR Asset Transaction means a transaction consummated at any time prior to the CVR Expiration Date pursuant to which the Company or any of its Affiliates grants, sells, licenses or otherwise transfers to a Third Party some or all of the rights to the CVR Assets, including any rights to research, develop or commercialize the CVR Assets, including a license, option, or sale of assets with respect to the CVR Assets; provided, that any such transaction involving any asset other than a CVR Asset shall not constitute a CVR Asset Transaction.
CVR Assets means any Intellectual Property and other assets that are used or held for use for the development of a Company Product, including all (a) regulatory filings made with respect to a Company Product; (b) regulatory approvals received with respect to a Company Product; and (c) clinical and non-clinical safety, and efficacy and pharmacokinetic data generated with respect to a Company Product.
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CVR Expiration Date means the seventh (7th) anniversary of the Closing.
CVR Payment means the payment of any CVR Payment Amount hereunder.
CVR Payment Amount means an amount equal to 80% of all Net Proceeds received by Company after the Closing pursuant to (i) the Approved Development Agreement, if any, and (ii) all CVR Transactions entered into prior to the CVR Expiration Date.
CVR Payment Date means the date (if any and if ever) that a CVR Payment is payable by the Company to the Holders, which date will be established pursuant to Section 2.4.
CVR Register has the meaning set forth in Section 2.3(b).
CVR Registrar has the meaning set forth in Section 2.3(b).
CVR Transaction means a CVR Asset Transaction. For clarity, (a) the grant of a license to any Third Party (including any contract research organization) for the purposes of conducting research on behalf of the Company with respect to the CVR Assets shall not be deemed a CVR Transaction and (b) the sale of all or substantially all of the Companys or any of its Affiliates stock or assets (to the extent such asset sale includes assets unrelated to the CVR Assets), or a merger, acquisition or similar transaction shall not be deemed a CVR Transaction. For the avoidance of doubt, (i) more than one CVR Transaction may occur under this Agreement and (ii) the execution and delivery of the Approved Development Agreement shall not constitute a CVR Transaction.
CVR Transaction Non-Achievement Certificate has the meaning set forth in Section 2.4(c).
Development Transaction Non-Achievement Certificate has the meaning set forth in Section 2.4(c).
Holder means a Person in whose name a CVR is registered in the CVR Register.
Holder Representative means the Holder Representative named in the first paragraph of this Agreement, until a successor Holder Representative has become such pursuant to the applicable provisions of this Agreement, and thereafter Holder Representative will mean such successor Holder Representative.
Intellectual Property means all intellectual property, including the following items of intangible property, and all rights associated therewith in any jurisdiction and tangible embodiments thereof: (a) all Patents; (b) all works of authorship, copyrights, whether or not registered, and all registrations and pending applications for registration of the same and renewals thereof and database rights; (c) all technology, technical information, know-how and data, including, without limitation, inventions (whether or not patentable of reduced to practice), improvements, discoveries, trade secrets, specifications, instructions, ideas, processes, methods, formulations, formulae, protocols, materials, assays, screens, algorithms, models, databases, expertise and other technology applicable to formulations, compositions or products or to their manufacture, development, registration, use or marketing or to methods of assaying or testing them or processes for their manufacture, formulations containing them or compositions incorporating or comprising them, and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, nonclinical, pre-clinical and clinical data, regulatory data and filings, instructions, processes, formulae, expertise and information, relevant to the research, development, manufacture, use, importation, offering for sale or sale of, and/or which may be useful in studying, testing, developing, producing or formulating, a Company Product, or intermediates for the synthesis thereof and chemistry, manufacturing and control information and data, lab notebooks, Patent data and records, stability, technology, test and other data and results; and (d) computer programs, including, without limitation, computer programs embodied in semiconductor chips or otherwise embodied, and related flow-charts, programmer notes, updates and data, whether in object or source code form.
Net Proceeds means an aggregate amount (without duplication) equal to the sum of: (a) all cash consideration actually received by the Company or its Affiliates from a Third Party (x) pursuant to the Approved Development Agreement after the Closing, if any, and (y) in connection with the consummation of a CVR Transaction, plus (b) with respect to any non-cash consideration actually received by the Company or its Affiliates from a Third Party prior to the CVR Expiration Date in connection with the consummation of a
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CVR Transaction, the fair market value of such non-cash consideration, as determined by the Board of Directors in good faith, less (c) all out-of-pocket transaction costs and expenses incurred by the Company or its Affiliates after the date of this Agreement to Third Parties for the negotiation, entry into and consummation of the Approved Development Agreement and a CVR Transaction, including any broker fees, finders fees, advisory fees, accountant or attorneys fees, and reasonable costs of recovery of any amounts payable to the Company in connection with the Approved Development Agreement or a CVR Transaction, less (d) all unreimbursed out-of-pocket costs and expenses incurred by the Company in performing its obligations under (x) the Approved Development Agreement in excess of 10% of the Budgeted Amount and (y) a CVR Transaction (collectively, Specified Costs), less (e) patent prosecution and maintenance costs and drug storage costs incurred by the Company with respect to the CVR Assets after the Closing Date, less (f) any applicable sales, income and other taxes incurred by the Company or its Affiliates in respect of the performance of the Companys obligations under the Approved Development Agreement or a CVR Transaction, and less (g) all out-of-pocket fees and costs (including any amounts paid for indemnification) payable by the Company to the Rights Agent pursuant to this Agreement in connection with the Approved Development Agreement or a CVR Transaction. For the avoidance of doubt, (A) Net Proceeds shall not include any payment or reimbursement to Company by a Third Party of Companys development expenses; (B) amounts placed in escrow or earnout, contingent or other post-closing payments, including milestone or royalty payments, in connection with the Approved Development Agreement or a CVR Transaction will not be considered Net Proceeds unless (and only to the extent that) such amounts are actually received by the Company prior to the CVR Expiration Period; and (C) if the Approved Development Transaction or a CVR Transaction occurs prior to the CVR Expiration Date, any such escrow, earnout, contingent or other post-closing payment released or paid after the CVR Expiration Date will be included in the calculation of Net Proceeds, so long as such amount is actually received by the Company or its Affiliates within the twelve (12)-month period immediately following the consummation of the Approved Development Transaction or such CVR Transaction. For the avoidance of doubt, any amount payable to the Company pursuant to the Approved Development Agreement or a CVR Transaction that is included in Net Cash or included in the Permitted Dividend (each, as defined in the Share Exchange Agreement) shall not constitute Net Proceeds.
Non-Achievement Certificate has the meaning set forth in Section 2.4(c).
Objection Notice has the meaning set forth in Section 2.4(d).
Objection Period has the meaning set forth in Section 2.4(d).
Officers Certificate means a certificate signed by the chief executive officer, president, chief financial officer or secretary of the Company, in his or her capacity as such an officer, and delivered to the Rights Agent and the Holder Representative.
Patents means all patents and patent applications (including provisional applications) and patent disclosures, and including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, re-issues, additions, renewals, extensions, confirmations, registrations, any confirmation patent or registration patent or patent of addition based on any such patent, patent term extensions, and supplemental protection certificates or requests for continued examinations and foreign counterparts, of any of the foregoing.
Permitted Transfer means: (i) the transfer of any or all of the CVRs (upon the death of the Holder) by will or intestacy; (ii) transfer by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death of the trustee; (iii) transfers made pursuant to a court order of a court of competent jurisdiction (such as in connection with divorce, bankruptcy or liquidation); (iv) if the Holder is a partnership or limited liability company, a pro-rata distribution by the transferring partnership or limited liability company to its partners or members, as applicable; (v) a transfer made by operation of law (including a consolidation or merger) or in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; (vi) a transfer from a participants account in a tax-qualified employee benefit plan to the participant or to such participants account in a different tax-qualified employee benefit plan or to a tax-qualified individual retirement account for the benefit of such participant; (vii) a transfer from a participant in a tax-qualified employee benefit plan, who received the CVRs from such participants account in such tax-qualified employee benefit plan, to such participants account in a different
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tax-qualified employee benefit plan or to a tax-qualified individual retirement account for the benefit of such participant; or (viii) in the case of CVRs held in book-entry form or other similar nominee form, from a nominee to a beneficial owner (and, if applicable, through an intermediary) or from such nominee to another nominee for the same beneficial owner, in each case as allowable by DTC.
Person means an individual, a corporation, a limited liability company, a partnership, an association, a trust or any other entity or organization, including a government or political subdivision or any agency or instrumentality thereof.
Record Date means [], 2020.
Reporting Certificate has the meaning set forth in Section 2.4(a).
Rights Agent means the Rights Agent named in the first paragraph of this Agreement, until a successor Rights Agent has become such pursuant to the applicable provisions of this Agreement, and thereafter Rights Agent will mean such successor Rights Agent.
Rights Agent Fee means the agreed-upon fee of the Rights Agent to act in such capacity pursuant to the terms of this Agreement.
Surviving Person has the meaning set forth in Section 6.1(a)(i).
Target Execution Date means the date that is six (6) months after the Closing.
Term Sheet means the term sheet for the Approved Development Transaction disclosed to F-Star in Companys data room prior to the date of the Share Exchange Agreement.
Third Party means any Person other than the Company or the Rights Agent or their respective Affiliates.
ARTICLE X
CONTINGENT VALUE RIGHTS
10.1 Authority; Issuance of CVRs; Appointment of Rights Agent.
(a) The Company has all requisite corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated by this Agreement. The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by all necessary corporate action on the part of the Company and no other corporate proceedings on the part of the Company are necessary to authorize this Agreement or to consummate the transactions contemplated hereby. Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby will (i) result in any violation of any provision of the Certificate of Incorporation or By-laws of the Company, or (ii) result in any violation of any loan or credit agreement, note, mortgage, indenture, lease, or other agreement, obligation, instrument, permit, concession, franchise, license, judgment, order, decree, statute, law, ordinance, rule or regulation applicable to Company or its properties or assets which violation, in the case of clause (ii), individually or in the aggregate, would reasonably be expected to be material to the Company. No consent, approval, order or authorization of, or registration, declaration or filing with, any Governmental Body is required by or with respect to the Company in connection with the execution and delivery of this Agreement by the Company or the consummation by the Company of the transactions contemplated hereby.
(b) One CVR will be issued with respect to each share of Common Stock that is outstanding as of 5:01 p.m. Eastern Time on the Record Date.
(c) The Company hereby appoints Computershare Trust Company N.A. as the Rights Agent to act as rights agent for the Company in accordance with the instructions hereinafter set forth in this Agreement, and Computershare Trust Company N.A. hereby accepts such appointment.
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10.2 Nontransferable. The CVRs may not be sold, assigned, transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than through a Permitted Transfer. Any purported transfer of a CVR other than in a Permitted Transfer shall be null and void ab initio.
10.3 No Certificate; Registration; Registration of Transfer; Change of Address.
(a) The CVRs will be issued in book-entry form only and will not be evidenced by a certificate or other instrument.
(b) The Rights Agent will keep a register (the CVR Register) for the registration of the CVRs. The Rights Agent is hereby initially appointed CVR Registrar for the purpose of registering the CVRs and Permitted Transfers of the CVRs as herein provided. Upon any change in the identity of the Rights Agent, the successor Rights Agent will automatically also become the successor CVR Registrar.
(c) Subject to the restrictions on transferability set forth in Section 2.2, every request made to transfer a CVR must be in writing and accompanied by a written instrument or instruments of transfer and any other requested documentation in a form reasonably satisfactory to the Company and the CVR Registrar, duly executed by the registered Holder or Holders thereof or by the duly appointed legal representative thereof or by a duly authorized attorney, including the evidence of authority of the party presenting the CVR for transfer, which authority may include, if applicable, a signature guarantee from an eligible guarantor institution participating in a signature guarantee program approved by the Securities Transfer Association. A request for a transfer of a CVR must be accompanied by such documentation establishing that the transfer is a Permitted Transfer as may be reasonably requested by the Company and/or the CVR Registrar, if appropriate. Upon receipt of such written request and materials, the CVR Registrar will, subject to its reasonable determination that the transfer instrument is in proper form and the transfer otherwise complies with the other terms and conditions herein, register the transfer of the CVRs in the CVR Register. All duly transferred CVRs registered in the CVR Register will be the valid obligations of the Company, evidencing the same right and will entitle the transferee to the same benefits and rights under this Agreement as those previously held by the transferor. No transfer of a CVR will be valid until registered in the CVR Register, and any transfer not duly registered in the CVR Register will be void and invalid. All costs and expenses related to any transfer or assignment of the CVRs (including the cost of any transfer tax) will be the responsibility of the transferor.
(d) A Holder (or an authorized representative thereof) may make a request to the CVR Registrar to change such Holders address of record in the CVR Register. Upon receipt of such request, the CVR Registrar will promptly record the change of address in the CVR Register.
10.4 Payment Procedures.
(a) As soon as practicable following the receipt by the Company of Net Proceeds from (i) the Approved Development Agreement, if any, after the Closing, but in no event later than thirty (30) days after the receipt of such payments, or (ii) a CVR Transaction, but in no event later than thirty (30) days after the closing of such CVR Transaction, and within thirty (30) days after the end of any calendar quarter in which the Company has received Net Proceeds from any CVR Transaction, the Company will deliver to the Holder Representative and the Rights Agent a certificate (each, a Reporting Certificate), certifying that the Holders are entitled to receive a CVR Payment and setting forth the Companys calculation of the CVR Payment Amount.
(b) [reserved]
(c) If the Approved Development Agreement has not been executed and delivered prior to the Target Execution Date, then, as soon as reasonably practicable after the Target Execution Date, but in no event later than thirty (30) days after the Target Execution Date, the Company will deliver to the Holder Representative and the Rights Agent a certificate (the Development Agreement Non-Achievement Certificate), stating that the Approved Development Agreement has not been executed and delivered prior to the Target Execution Date. If no CVR Transaction has been effected prior to the CVR Expiration Date, then, as soon as reasonably practicable after the CVR Expiration Date, but in no event later than thirty (30) days after the CVR Expiration Date, the Company will deliver to the Holder Representative and the Rights Agent a certificate (the CVR Transaction
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Non-Achievement Certificate and, together with the Development Agreement Non-Achievement Certificate, each a Non-Achievement Certificate, and the Non-Achievement Certificates, together with the Reporting Certificate(s), the Certificates), stating that no CVR Transaction has been consummated prior to the CVR Expiration Date.
(d) If the Holder Representative does not object to any determination or calculation set forth in a Certificate by delivery of a written notice thereof to the Company setting forth in reasonable detail such objection, together with reasonable supporting documentation (an Objection Notice), within thirty (30) days following receipt of the applicable Certificate (the Objection Period), the Companys determination of the non-existence of the Approved Development Agreement or a CVR Transaction, or the calculation of the CVR Payment Amount, as applicable, shall be final and binding on all parties. If the Holder Representative timely delivers to the Company an Objection Notice, the Company and the Holder Representative shall attempt in good faith to resolve such matters within thirty (30) days after receipt of the same by the Company, and if unable to do so, the Company and the Holder Representative shall resolve any unresolved disputed in accordance with Section 8.11, which decision will be final and binding on the parties, absent manifest error. The Company shall, within ten (10) Business Days following the final determination of the CVR Payment Amount pay such CVR Payment Amount to the Rights Agent (for the account of the Holders) by wire transfer of immediately available funds to such account as may be designated by the Rights Agent. The Rights Agent will distribute the CVR Payment Amount to the Holders (each Holder being entitled to receive its pro rata share of such CVR Payment Amount, as applicable, based on the number of CVRs held by such Holder as reflected on the CVR Register on the date of the Reporting Certificate or the date of final determination pursuant to this Agreement, as applicable) (i) by check mailed to the address of each such respective Holder as reflected in the CVR Register as of the close of business on the last Business Day before such CVR Payment Date, or, (ii) with respect to any Holder who has provided the Rights Agent with wire transfer instructions meeting the Rights Agents requirements, by wire transfer of immediately available funds to such account.
(e) If an Objection Notice has not been timely delivered to the Company in response to a Non-Achievement Certificate within the Objection Period, then the Holders will have no right to receive a CVR Payment, and the Company and the Rights Agent will have no further obligations with respect to any CVR Payment.
(f) If the amount of Net Proceeds used to calculate any CVR Payment Amount is reduced by any Specified Costs and, following payment of such CVR Payment Amount, the Company receives reimbursement for such Specified Costs pursuant to the Approved Development Agreement or CVR Transaction, as applicable, then an amount equal to 80% of such reimbursed Specified Costs shall be added to the next CVR Payment Amount to become payable hereunder to the Holders, and if no additional CVR Payment Amount becomes payable, the Company shall pay such portion of the reimbursed Specified Costs to the Holders through a special distribution to be paid within thirty (30) days after receipt of such reimbursement.
(g) The Company will be entitled to deduct and withhold, or cause to be deducted or withheld, from any CVR Payment Amount or other amount payable pursuant to this Agreement, such amounts as the Company is required to deduct and withhold with respect to the making of such payment under the Internal Revenue Code, or any provision of state or local tax law. To the extent that amounts are so withheld or paid over to or deposited with the relevant governmental entity, such withheld amounts will be treated for all purposes of this Agreement as having been paid to the Holder in respect of which such deduction and withholding was made.
(h) Subject to prior execution and delivery by the Holder Representative of a reasonable and customary confidentiality and market stand-off agreement, the Company shall provide the Holder Representative with reasonable access during normal business hours and upon reasonable advance request to the books and records of the Company to the extent necessary to verify (i) whether the Approved Development Agreement was executed and delivered prior to the Target Execution Date, (ii) whether a CVR Transaction occurred prior to the CVR Expiration Date or (iii) the Companys calculation of the CVR Payment Amount, as applicable; it being understood that the Holder Representatives rights under this Section 2.4(g) shall terminate upon the later of (i) the CVR Expiration Date or (ii) thirty (30) days after the delivery to the Holder Representative of a Reporting Certificate.
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(i) The Company will promptly furnish to the Rights Agent all information and documentation in connection with this Agreement and the CVRs that the Rights Agent may reasonably request in order to perform under this Agreement.
(j) The Company acknowledges that the bank accounts maintained by the Rights Agent in connection with the services provided under this Agreement will be in the Rights Agents name and that the Rights Agent may receive investment earnings in connection with the investment at the Rights Agents risk and for its benefit of funds held in those accounts from time to time.
10.5 No Voting, Dividends or Interest; No Equity or Ownership Interest in the Company.
(a) The CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable on the CVRs to any Holder.
(b) The CVRs will not represent any equity or ownership interest in the Company. The rights of the Holders and the obligations of the Company are contract rights limited to those expressly set forth in this Agreement, and such Holders sole right to receive property hereunder is the right to receive cash from the Company, if any, through the Rights Agent in accordance with the terms hereof. It is hereby acknowledged and agreed that a CVR shall not constitute a security of the Company.
10.6 Holders Right to Abandon CVR. A Holder may at any time, at such Holders option, abandon all of such Holders remaining rights in a CVR by transferring such CVR to the Company or any of its Affiliates without consideration. Nothing in this Agreement shall prohibit the Company or its Affiliates from offering to acquire or acquiring CVRs, in private transactions or otherwise, in its sole discretion. Any CVRs acquired by the Company or any of its Affiliates shall be automatically deemed extinguished and no longer outstanding hereunder for any purpose.
ARTICLE XI
THE RIGHTS AGENT
11.1 Certain Duties and Responsibilities.
(a) The Rights Agent will not have any liability for any actions taken or not taken in connection with this Agreement, except to the extent of its willful misconduct, bad faith or gross negligence. No provision of this Agreement will require the Rights Agent to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of any of its rights or powers. Notwithstanding anything contained herein to the contrary, the Rights Agents aggregate liability under this Agreement, or from all services provided or omitted to be provided under this Agreement, whether in contract, or in tort, or otherwise, is limited to, and shall not exceed, the amounts paid hereunder by the Company to the Rights Agent as fees and charges, but not including reimbursable expenses.
(b) The Holder Representative may direct the Rights Agent to act on behalf of the Holders in enforcing any of its or their rights hereunder, including the delivery of any Objection Notice and negotiation or arbitration pursuant to Section 8.11; provided, however, the Rights Agent may not act on behalf of the Holders or the Holder Representative in any dispute relating to or arising under Section 4.3 or relating to whether the Approved Development Agreement has been executed and delivered or a CVR Transaction has occurred or the amount of any CVR Payment. The Rights Agent will be under no obligation to institute any action, suit or legal proceeding or to take any other action likely to involve material expense unless the Holder Representative will furnish the Rights Agent with reasonable security and indemnity for any costs and expenses that may be incurred. All rights of action under this Agreement may be enforced by the Rights Agent, and any action, suit or proceeding instituted by the Rights Agent on behalf of the Holders will be brought in its name as Rights Agent, and any recovery of judgment will be for the ratable benefit of all the Holders, as their respective rights or interests may appear.
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11.2 Certain Rights of Rights Agent. The Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied covenants or obligations will be read into this Agreement against the Rights Agent. In addition:
(a) the Rights Agent may rely and will be protected in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document reasonably believed by it to be genuine and to have been signed or presented by the proper party or parties;
(b) whenever the Rights Agent will deem it desirable that a matter be proved or established before taking, suffering or omitting any action hereunder, the Rights Agent may, in the absence of willful misconduct, bad faith or gross negligence on its part, rely upon an Officers Certificate;
(c) the Rights Agent may engage and consult with counsel of its selection and the written advice of such counsel or any opinion of counsel will be full and complete authorization and protection in respect of any action taken, suffered or omitted by it hereunder in good faith and in reliance thereon;
(d) in the event of arbitration, the Rights Agent may engage and consult with tax experts, valuation firms and other experts and third parties that it, in its sole and absolute discretion, deems appropriate or necessary to enable it to discharge its duties hereunder;
(e) the permissive rights of the Rights Agent to do things enumerated in this Agreement will not be construed as a duty;
(f) the Rights Agent will not be required to give any note or surety in respect of the execution of such powers or otherwise in respect of the premises;
(g) the Company agrees to indemnify the Rights Agent for, and hold the Rights Agent harmless against, any loss, liability, claim, demands, suits or expense (in each case pertaining to the Rights Agents own account only) arising out of or in connection with the Rights Agents duties under this Agreement, including the costs and expenses of defending the Rights Agent against any claims, charges, demands, suits or loss, unless such loss has been determined by a court of competent jurisdiction to be a result of the Rights Agents willful misconduct, bad faith or gross negligence; and
(h) the Company agrees (i) to pay the fees and expenses of the Rights Agent in connection with this Agreement, as set forth on Schedule 1 hereto, and (ii) to reimburse the Rights Agent for all taxes and governmental charges, reasonable expenses and other charges of any kind and nature incurred by the Rights Agent in the execution of this Agreement (other than taxes imposed on or measured by the Rights Agents net income and franchise or similar taxes imposed on it). The Rights Agent will also be entitled to reimbursement from the Company for all reasonable and necessary out-of-pocket expenses (including reasonable fees and expenses of the Rights Agents counsel and agent) paid or incurred by it in connection with the administration by the Rights Agent of its duties hereunder. An invoice for the Rights Agent Fee will be rendered a reasonable time before, and paid on, the effective date of the applicable transaction. An invoice for any out-of-pocket expenses and per item fees realized will be rendered and payable within thirty (30) days after receipt by the Company. The Company agrees to pay to Rights Agent any amounts, including fees and expenses, payable in favor of the Rights Agent in connection with any dispute, resolution or arbitration arising under or in connection with the Agreement; and any fees and expenses, payable by the Company in favor of the Rights Agent or payable in favor of the Company related to such dispute, resolution or arbitration will be offset against any CVR Payments, if any, or any other payment to be made thereafter under this Agreement.
11.3 Resignation and Removal; Appointment of Successor.
(a) The Rights Agent may resign at any time by giving written notice thereof to the Company, specifying a date when such resignation will take effect, which notice will be sent at least thirty (30) days before the date so specified.
(b) If the Rights Agent provides notice of its intent to resign, is removed or becomes incapable of acting, the Company, by way of a Board Resolution, will as soon as practicable appoint a qualified successor
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Rights Agent who, unless otherwise consented to in writing by the Holder Representative, shall be a stock transfer agent of national reputation or the corporate trust department of a commercial bank. The successor Rights Agent so appointed will, forthwith upon its acceptance of such appointment in accordance with Section 3.4, become the successor Rights Agent.
(c) The Company will give notice of each resignation and each removal of a Rights Agent and each appointment of a successor Rights Agent by mailing written notice of such event by first-class mail, postage prepaid, to the Holders as their names and addresses appear in the CVR Register and by delivering notice to the Holder Representative. Each notice will include the name and address of the successor Rights Agent. If the Company fails to send such notice within five (5) Business Days after acceptance of appointment by a successor Rights Agent, upon the Companys request the successor Rights Agent will cause such notice to be mailed at the expense of the Company.
11.4 Acceptance of Appointment by Successor. Every successor Rights Agent appointed hereunder will execute, acknowledge and deliver to the Company and to the retiring Rights Agent an instrument accepting such appointment and a counterpart of this Agreement, and thereupon such successor Rights Agent, without any further act, deed or conveyance, will become vested with all the rights, powers, trusts and duties of the retiring Rights Agent; provided, however, that upon the request of the Company or the successor Rights Agent, such retiring Rights Agent will cooperate in the transfer of all relevant data, including the CVR Register, to the successor Rights Agent.
ARTICLE XII
COVENANTS
12.1 List of Holders. The Company will furnish or cause to be furnished to the Holder Representative and the Rights Agent the names, addresses and shareholdings of registered holders of Common Stock as of 5:01 p.m. Eastern Time on the Record Date. The Company will promptly furnish an electronic copy of the CVR Register to the Holder Representative upon written request from the Holder Representative.
12.2 [RESERVED]
12.3 Diligence.
(a) The Company shall (i) from and after the Closing until the Target Execution Date, use Commercially Reasonable Efforts to negotiate and execute the Approved Development Agreement (to the extent not executed and delivered prior to Closing), (ii) from and after the execution date of the Approved Development Agreement (if at all) until the expiration or earlier termination of the Approved Development Agreement (other than as a result of a material breach thereof by the Company), use Commercially Reasonable Efforts to perform the Approved Development Transaction in accordance with the terms of the Approved Development Agreement, and (iii) from and after the execution date of the Approved Development Agreement (if at all), use Commercially Reasonable Efforts to pursue and seek to consummate CVR Transactions (subject to the terms of the Approved Development Agreement). Subject to the preceding sentence, the Company has no obligation to develop or expend any funds in connection with the development of any Company Product and has no obligation to license, sell or otherwise monetize any Company Product except as provided in the Approved Development Agreement (to the extent the Approved Development Agreement becomes a binding obligation of the Company prior to the Target Execution Date). Notwithstanding anything in this Agreement to the contrary, in no event shall the Company be required to (x) enter into an Approved Development Agreement on terms that deviate in any material and adverse respect from those set forth in the Term Sheet or (y) enter into any CVR Transaction on terms that are not customary for transactions of such type or that would impose material financial or performance obligations on the Company (other than customary indemnification provisions or ministerial requirements such as the collection and accounting for royalties), or would impose any non-competition covenant on the Company with respect to any product or program of the Company unrelated to a Company Product.
(b) Notwithstanding the foregoing, the obligation of the Company to use Commercially Reasonable Efforts pursuant to Section 4.3(a) shall not be deemed a guarantee that (i) an Approved Transaction Agreement will be executed and delivered by the Company, (ii) a CVR Transaction will occur, or (iii) any CVR Payment
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will be earned. Neither the Company nor any of its directors, officers or their respective Affiliates owes any fiduciary duty to the Holders with respect to the CVR Payments. Further, the parties acknowledge that the Companys sole obligations with respect to any potential CVR Payments are expressly set forth in this Agreement.
ARTICLE XIII
AMENDMENTS
13.1 Amendments Without Consent of Holder Representative.
(a) Without the consent of the Holder Representative or the Rights Agent, the Company, when authorized by a Board Resolution, at any time and from time to time, may enter into one or more amendments hereto, for any of the following purposes:
(i) to evidence the succession of another Person to the Company and the assumption by any such successor of the covenants of the Company herein in a transaction contemplated by Section 6.1 hereof; or
(ii) to evidence the termination of the CVR Registrar and the succession of another Person as a successor CVR Registrar and the assumption by any successor of the obligations of the CVR Registrar herein.
(b) Without the consent of the Holder Representative, the Company, when authorized by a Board Resolution, together with the Rights Agent, in the Rights Agents sole and absolute discretion, may at any time and from time to time, enter into one or more amendments hereto:
(i) to evidence the succession of another Person as a successor Rights Agent and the assumption by any successor of the covenants and obligations of the Rights Agent herein;
(ii) to add to the covenants of the Company such further covenants, restrictions, conditions or provisions as the Board of Directors and the Rights Agent will consider to be for the protection of the Holders;
(iii) to cure any ambiguity, to correct or supplement any provision herein that may be defective or inconsistent with any other provision herein; provided, however, that in each case, such provisions will not materially adversely affect the interests of the Holders;
(iv) as may be necessary to ensure that the CVRs are not subject to registration under the Securities Act of 1933, as amended, or the Exchange Act of 1934, as amended; or
(v) to add, eliminate or change any provision of this Agreement unless such addition, elimination or change is adverse to the interests of the Holders.
(c) Promptly after the execution by the Company and the Rights Agent of any amendment pursuant to the provisions of this Section 5.1, the Company will deliver a notice thereof to the Holder Representative, setting forth in general terms the substance of such amendment.
13.2 Amendments with Consent of Holder Representative. Subject to Section 5.1 (which amendments pursuant to Section 5.1 may be made without the consent of the Holder Representative), the Company, when authorized by a Board Resolution, and the Rights Agent and the Holder Representative may enter into one or more amendments hereto for the purpose of adding, eliminating or changing any or all provisions of this Agreement.
13.3 Execution of Amendments. In executing any amendment permitted by this Article V, the Rights Agent will be entitled to receive, and will be fully protected in relying upon, an opinion of counsel of the Company, at Companys sole expense, stating that the execution of such amendment is authorized or permitted by this Agreement. The Rights Agent may, but is not obligated to, enter into any such amendment that affects the Rights Agents own rights, privileges, covenants or duties under this Agreement or otherwise.
13.4 Effect of Amendments. Upon the execution of any amendment under this Article V, this Agreement will be modified in accordance therewith, such amendment will form a part of this Agreement for all purposes and every Holder will be bound thereby.
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ARTICLE XIV
CONSOLIDATION, MERGER, SALE OR CONVEYANCE
14.1 Effect of Merger or Consolidation.
(a) Except as contemplated by the Acquisition, the Company will not consolidate with or merge into any other Person or sell, transfer or otherwise convey all or substantially all of its assets, in one or a series of related transactions, to any Person, unless:
(i) the Person formed by such consolidation or into which the Company is merged or the Person that acquires by sale, transfer or other conveyance, all or substantially all of the assets of the Company (the Surviving Person) expressly assumes payment (if and to the extent required hereunder) of amounts on all the CVRs and the performance of every duty and covenant of this Agreement on the part of the Company to be performed or observed; and
(ii) the Company has delivered to the Holder Representative and the Rights Agent an Officers Certificate, stating that such consolidation, merger, conveyance, transfer or lease complies with this Article VI and that all conditions precedent herein provided for relating to such transaction have been complied with.
14.2 Successor Substituted. Upon any consolidation of or merger by the Company with or into any other Person, or any conveyance, transfer or lease of the properties and assets substantially as an entirety to any Person in accordance with Section 6.1, the Surviving Person will succeed to, and be substituted for, and may exercise every right and power of, the Company under this Agreement with the same effect as if the Surviving Person had been named as the Company herein, and thereafter the predecessor Person will be relieved of all obligations and covenants under this Agreement and the CVRs.
ARTICLE XV
THE HOLDER REPRESENTATIVE
15.1 Appointment. Effective upon the issuance of the CVRs under this terms of this Agreement, and without any further act of any of Holders, the Holder Representative is appointed as the representative of the Holders and as the attorney-in-fact and agent for and on behalf of each Holder for purposes of this Agreement and will take such actions to be taken by the Holder Representative under this Agreement and such other actions on behalf of such Holders as it may deem necessary or appropriate in connection with or to consummate the transactions contemplated hereby, including (i) executing and delivering this Agreement and any other ancillary documents and negotiating and executing any amendments, modifications, waivers or changes thereto as to which the Holder Representative, in its sole discretion, has consented (provided that any waiver or amendment that adversely and disproportionately affects the rights or obligations of one or more Holders as compared to other Holders will require the prior written consent of a majority in interest of the disproportionately affected Holders), (ii) agreeing to, negotiating, entering into settlements and compromises of, complying with orders of courts with respect to, and otherwise administering and handling any claims under this Agreement on behalf of such Holders, and (iii) taking all other actions that are either necessary or appropriate in the judgment of the Holder Representative for the accomplishment of the foregoing or contemplated by the terms of this Agreement. The Holder Representative hereby accepts such appointment and agrees to serve as such without compensation. The appointment of the Holder Representative as each Holders attorney-in-fact revokes any power of attorney heretofore granted that authorized any other Person to represent such Holder with regard to this Agreement and any other agreements or documents executed or delivered in connection with this Agreement. The Holder Representative is the sole and exclusive representative of each of the Holders for any purpose provided for by this Agreement.
15.2 Actions of Holder Representative.
(a) A decision, act, consent or instruction of the Holder Representative hereunder will constitute a decision, act, consent or instruction of all Holders and will be final, binding and conclusive upon each such Holder, and the Company and the Rights Agent may rely upon any such decision, act, consent or instruction of
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the Holder Representative as being the decision, act, consent or instruction of each and every such Holder. The Company and the Rights Agent will be relieved from any liability to any Person for any acts done by them in accordance with such decision, act, consent or instruction of the Holder Representative.
(b) The Holder Representative will incur no liability with respect to any action taken or suffered by any Holder in reliance upon any notice, direction, instruction, consent, statement or other document believed by such Holder Representative to be genuine and to have been signed by such Holder (and will have no responsibility to determine the authenticity thereof), nor for any other action or inaction, except the gross negligence, bad faith or willful misconduct of the Holder Representative. In all questions arising under this Agreement, the Holder Representative may rely on the advice of outside counsel, and the Holder Representative will not be liable to any Holder for anything done, omitted or suffered in good faith by Holder Representative based on such advice.
(c) The Holders will severally (on a pro rata basis, based on the number of CVRs held by each Holder), but not jointly, indemnify the Holder Representative and hold the Holder Representative harmless against any loss, liability or expense incurred without gross negligence, bad faith or willful misconduct on the part of the Holder Representative and arising out of or in connection with the acceptance or administration of the Holder Representatives duties hereunder, including the reasonable fees and expenses of any legal counsel or other advisors reasonably retained by the Holder Representative, to the extent not reimbursed by the Company pursuant to Section 7.2(d).
(d) In connection with providing services under this Agreement, the Holder Representative will be reimbursed by the Company for all reasonable fees and expenses incurred in providing such services. Any such fees and expenses will be paid by the Company within thirty (30) days of the receipt of an invoice from the Holder Representative and will be offset against the CVR Payment Amount, if any.
15.3 Removal; Appointment of Successor.
(a) At any time Holders representing at least a majority of the outstanding CVRs may, by written consent, appoint another Person as Holder Representative. Notice, together with a copy of the written consent appointing such Person and bearing the signatures of Holders of at least a majority of the outstanding CVRs, must be delivered to the Company and the Rights Agent. Such appointment will be effective upon the later of the date indicated in the consent or the date ten (10) days after such consent is received by the Company and the Rights Agent.
(b) If the Holder Representative becomes unable or unwilling to continue in his or its capacity as the Holder Representative, or if the Holder Representative resigns as a Holder Representative, the Holder Representative may appoint a new representative as the Holder Representative. If the Holder Representative is unable or unwilling to appoint a successor Holder Representative, then the board of directors of the Company shall appoint another Person as Holder Representative. Notice and a copy of the written consent appointing such Person must be delivered to the Company and the Rights Agent not less than ten (10) days prior to such appointment. Such appointment will be effective upon the later of the date indicated in the consent or the date ten (10) days after such consent is received by the Company and the Rights Agent.
15.4 Grant of Authority. The grant of authority provided for in this Article VII is coupled with an interest and will be irrevocable and survive the death, incompetency, bankruptcy or liquidation of any Holder. The provisions of this Article VII will be binding upon the executors, heirs, legal representatives, successors and assigns of each Holder, and any references in this Agreement to any Holder or the Holders will mean and include the successors to such Holders rights hereunder, whether pursuant to testamentary disposition, the laws of descent and distribution or otherwise.
ARTICLE XVI
OTHER PROVISIONS OF GENERAL APPLICATION
16.1 Notices to Rights Agent, Company and Holder Representative. Subject to Section 8.2, all notices, requests, demands, claims and other communications that are required to be or may be given under this Agreement must be in writing and will be deemed to have been effectively given: (a) upon personal delivery to
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the recipient; (b) when sent by e-mail transmission, if sent during normal business hours of the recipient; if not, then on the next Business Day; or (c) one Business Day after deposit with a nationally recognized overnight courier, specifying next-day delivery, with written verification of receipt, in each case to the intended recipient at the following addresses:
(a) if to the Company, to
[●] | ||
with a copy (which shall not constitute notice) to: | ||
[●]; |
(b) if to the Rights Agent, to
[●] | ||
with a copy (which shall not constitute notice) to: | ||
[●]; and |
(c) if to the Holder Representative, to
[●] | ||
with a copy (which shall not constitute notice) to: | ||
[●] |
or to such other address as any party has furnished to the other parties by notice given in accordance with this Section 8.1.
16.2 Notice to Holders. Where this Agreement provides for notice to Holders, such notice will be sufficiently given (unless otherwise herein expressly provided) if in writing and mailed, first-class postage prepaid, to each Holder affected by such event, at his, her or its address as it appears in the CVR Register, not later than the latest date, and not earlier than the earliest date, prescribed for the giving of such notice. In any case where notice to Holders is given by mail, neither the failure to mail such notice, nor any defect in any notice so mailed, to any particular Holder will affect the sufficiency of such notice with respect to other Holders.
16.3 Entire Agreement. This Agreement represents the entire understanding of the parties hereto with reference to the CVRs and this Agreement supersedes any and all other oral or written agreements made with respect to the CVRs. No party has relied on any other express or implied representation or warranty, either written or oral in connection with its entry into this Agreement, including any representation or warranty arising under statute or otherwise under law.
16.4 Legal Holidays. If a CVR Payment Date is not a Business Day, then, notwithstanding any provision of this Agreement to the contrary, any payment required to be made in respect of the CVRs on such date need not be made on such date, but may be made on the next succeeding Business Day with the same force and effect as if made on the CVR Payment Date.
16.5 Assignment. The Company may not assign this Agreement without the prior written consent of the Holder Representative; provided that the Company may assign, in its sole discretion and without the consent of any other party, any or all of its rights, interests and obligations hereunder to one or more direct or indirect wholly-owned subsidiaries of the Company (each, an Assignee) provided that the Assignee agrees to assume and be bound by all of the terms of this Agreement; provided, however, that in connection with any assignment to an Assignee, the Company shall, and shall agree to, remain liable for the performance by such Assignee of all obligations of the Company hereunder.
16.6 Third Party Beneficiaries. This Agreement will be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns. Nothing in this Agreement, express or implied, will give to any Person (other than the parties hereto, the Holders and their permitted successors and assigns hereunder) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any
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covenant or provision herein contained, all such covenants and provisions being for the sole benefit of the parties hereto, the Holders and their permitted successors and assigns.
16.7 Termination. This Agreement will terminate and be of no further force or effect, and the parties hereto will have no liability hereunder, upon the earliest to occur of: (a) the payment of the last possible CVR Payment due hereunder, (b) if an Objection Notice to a Non-Achievement Certificate is not delivered within the Objection Period, the expiration of the Objection Period, (c) in the event of the delivery of an Objection Notice, either (i) the final determination in accordance with this Agreement that an Approved Development Agreement has not been executed and delivered or (ii) the fulfillment of any payment obligation required pursuant to a final determination made in accordance with this Agreement, or (d) the termination of the Approved Development Agreement for reason other than breach thereof by the Company.
16.8 Survival. Notwithstanding anything in this Agreement to the contrary, all provisions regarding indemnification, warranty, liability and limits thereon, and confidentiality shall survive the termination or expiration of this Agreement.
16.9 Governing Law. This Agreement and the CVRs will be governed by, and construed in accordance with, the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws thereof.
16.10 Remedies. The Holders will not have any rights or remedies with respect to the CVRs except as expressly set forth herein.
16.11 Disputes.
(a)Before any arbitration pursuant to Section 8.11(b), the Company, the Rights Agent and the Holder Representative will negotiate in good faith for a period of thirty (30) days to resolve any controversy or claim arising out of or relating to this Agreement or the breach thereof.
(b) Any and all disputes arising under this Agreement (including but not limited to any claims brought by the Holder Representative on behalf of the Holders) shall be settled by final and binding arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules, except as modified herein. Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. In any arbitration under this Section 8.11(b), the number of arbitrators will be one, and such arbitrator will be selected in accordance with the AAAs Commercial Arbitration Rules. The place of the arbitration will be []. The arbitrator will be a lawyer or retired judge with experience in the biopharmaceutical industry and with mergers and acquisitions. Each party will, upon written request of the other party, promptly provide the other with copies of all relevant documents. There shall be no other discovery allowed. In making determinations regarding the scope of exchange of electronic information, the arbitrator and the parties agree to be guided by The Sedona Principles, Third Edition: Best Practices, Recommendations & Principles for Addressing Electronic Document Production. Time is of the essence for any arbitration under this Agreement and arbitration hearings shall take place within 90 days of filing and awards rendered within 120 days. The hearing shall not last longer than two days, with each hearing day lasting no longer than eight (8) hours. The arbitrator shall agree to these limits prior to accepting appointment. Except as may be required by law, neither a party nor the arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of the other parties (provided that the Holder Representative may disclose to the Holders any such information without the consent of the Company). The fees and expenses of the arbitration, including the costs and expenses billed by the arbitrator in connection with the performance of its duties described herein, will be paid by the non-prevailing party, as determined by the arbitrator, in proportion with the extent to which the prevailing party prevails, and the remainder of such costs and expenses will be paid by the prevailing party; provided, however, that any fees and expenses of the arbitration incurred by the Holder Representative shall be offset against any CVR Payment Amount, if any. Each party will be responsible for its own attorney fees, expenses and costs of investigation provided, however, that any such fees, expenses and costs incurred by the Holder Representative shall be offset against any CVR Payment Amount, if any.
16.12 Confidentiality.
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(a) Confidential Information shall mean any and all technical, scientific or business information relating to a party, including, without limitation, financial, marketing and product development information, stockholder information (including any non-public information of such stockholder), and proprietary information that is disclosed or otherwise becomes known to the other party or its Affiliates, agents or representatives before or during the term of this Agreement. Confidential Information constitutes trade secrets and is of great value to the owner (or its Affiliates). Confidential Information shall not include any information that is: (a) already known to the other party or its Affiliates at the time of the disclosure, provided that such prior knowledge can be substantiated by the written records of such party; (b) publicly known at the time of the disclosure or becomes publicly known through no wrongful act or failure of the other party; (c) subsequently disclosed to the other party or its Affiliates on a non-confidential basis by a third party not having a confidential relationship with the owner and which rightfully acquired such information; or (d) independently developed by one party without access to the Confidential Information of the other, provided that such independent development can be substantiated by the written records of such party. This Agreement, including all of its terms and conditions, will not be deemed to be Confidential Information and may be publicly disclosed by the Company.
(b) All Confidential Information of a party will be held in confidence by the other party with at least the same degree of care as such party protects its own confidential or proprietary information of like kind and import, but not less than a reasonable degree of care. Neither party will disclose in any manner Confidential Information of the other party in any form to any person or entity without the other partys prior consent. However, each party may disclose relevant aspects of the other partys Confidential Information to its officers, Affiliates, agents, subcontractors and employees to the extent reasonably necessary to perform its duties and obligations under this Agreement. Without limiting the foregoing, each party will implement such physical and other security measures and controls as are necessary to protect (a) the security and confidentiality of Confidential Information; (b) against any threats or hazards to the security and integrity of Confidential Information; and (c) against any unauthorized access to or use of Confidential Information. To the extent that a party delegates any duties and responsibilities under this Agreement to an agent or other subcontractor, the party ensures that such agent and subcontractor are contractually bound to confidentiality terms consistent with the terms of this Section 8.13.
(c) In the event that any requests or demands are made for the disclosure of Confidential Information, other than requests to Rights Agent for stockholder records pursuant to standard subpoenas from state or federal government authorities (e.g., divorce and criminal actions), the party receiving such request will promptly notify the other party to secure instructions from an authorized officer of such party as to such request and to enable the other party the opportunity to obtain a protective order or other confidential treatment, unless such notification is otherwise prohibited by law or court order. Each party expressly reserves the right, however, to disclose Confidential Information to any person whenever it is advised by counsel that it may be held liable for the failure to disclose such Confidential Information or if required by law or court order.
(d) As may be required by law and without limiting any partys rights in respect of a breach of this Section 8.12, each party will promptly:
(i) notify the other party in writing of any unauthorized possession, use or disclosure of the other partys Confidential Information by any person or entity that may become known to such party;
(ii) furnish to the other party full details of the unauthorized possession, use or disclosure; and
(iii) use commercially reasonable efforts to prevent a recurrence of any such unauthorized possession, use or disclosure of Confidential Information.
16.13 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. Delivery of a signed Agreement by reliable electronic means, including facsimile, email, or any electronic signature complying with the U.S. federal ESIGN Act of 2000 (including DocuSign) shall be an effective method of delivering the executed Agreement. This Agreement may be stored by electronic means and either an original or an electronically stored copy of this Agreement can be used for all purposes, including in any proceeding to enforce the rights and/or obligations of the parties to this Agreement.
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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf by its duly authorized officers as of the day and year first above written.
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Schedule 1
Rights Agent Fees
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EXHIBIT F
DEED OF TERMINATION SHAREHOLDERS AGREEMENT
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Execution Version
EXHIBIT G
FORM OF JOINDER AGREEMENT
JOINDER AGREEMENT
IN WITNESS WHEREOF, the undersigned shareholder (the Shareholder) has executed this Joinder Agreement (this Joinder Agreement) to that certain Share Exchange Agreement (as amended, supplemented or otherwise modified, the Share Exchange Agreement), dated as of [], 2020, by and among Spring Bank Pharmaceuticals, Inc., a Delaware corporation (Company), F-Star Therapeutics Limited, a company registered in England and Wales with company number 11532458, and the Persons listed on Schedule I to the Share Exchange Agreement, including each Person who becomes a party thereto by executing and delivering this Joinder Agreement (as contemplated by Sections 6.11 and 6.12 of the Share Exchange Agreement) (Sellers), pursuant to which, upon the terms and subject to the conditions thereof, the Sellers will sell, transfer and convey to Company, and Company will purchase from Sellers, all of the issued and outstanding F-Star Shares (the Acquisition). The Shareholder delivers this Joinder Agreement as of the date set forth on the signature page hereto pursuant to the Share Exchange Agreement. Capitalized terms used but not defined in this Joinder Agreement shall have the respective meanings ascribed to such terms in the Share Exchange Agreement.
1. Joinder. By executing and delivering this Joinder Agreement, the Shareholder hereby (a) confirms to the parties to the Share Exchange Agreement that the Shareholder has received a copy of and has reviewed the Share Exchange Agreement and (b) agrees that the Shareholder shall, from and after the date hereof, be fully bound by and subject to the provisions of, and be a party to, the Share Exchange Agreement as a Seller thereunder as though an original party thereto (including, without limitation, making all representations and warranties of a Seller thereunder as set forth in Article 4 of the Share Exchange Agreement).
2. Organization. The Shareholder represents and warrants that if the Shareholder is an entity, the Shareholder is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization.
3. Authorization, Execution, and Enforceability. The Shareholder represents and warrants that (a) if the Shareholder is an entity, (i) the Shareholder has all requisite corporate, limited liability company or similar power and authority (including under its constitution) to execute, deliver and perform its obligations under this Joinder Agreement and to consummate the transactions contemplated hereby and (ii) the execution and delivery by the Shareholder of this Joinder Agreement, and the performance by the Shareholder of its obligations under this Joinder Agreement have been duly and validly authorized by all necessary corporate or limited liability actions, consents, resolutions or similar actions on the part of the Shareholder; (b) if the Shareholder is a natural person, such Seller has the requisite legal capacity to execute, deliver and perform its obligations under this Joinder Agreement and to consummate the transactions contemplated hereby; (c) the Shareholder is not subject to any Insolvency Proceedings; (d) this Joinder Agreement has been duly executed and delivered by the Shareholder; and (e) this Joinder Agreement constitutes a valid and binding obligation of the Shareholder, enforceable against the Shareholder in accordance with its terms, except as may be limited by bankruptcy, insolvency, reorganization, moratorium and other Legal Requirements affecting creditors rights generally, or by general principles of equity (regardless of whether enforceability is considered in a proceeding at law or in equity).
4. Non-Contravention. The Shareholder represents and warrants that the execution and delivery by the Shareholder of this Joinder Agreement and the performance by the Shareholder of the Shareholders obligations hereunder does not and will not: (a) if the Shareholder is an entity, violate any provision of the Organizational Documents of the Shareholder; (b) in any material respect, result in a violation or breach of, constitute a default under, result in the acceleration of, give rise to any right to accelerate, terminate, modify or cancel, or require any notice, consent, authorization, approval or waiver under, or result in any other adverse consequence under, any Contract to which the Shareholder is a party or by which the Shareholder or any of the Shareholders assets or properties is bound; (c) result in a violation of any law or regulation in any jurisdiction having the force of law or of any order, judgment or decree of any Governmental Body or agreement to which the Shareholder is a party or
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by which the Shareholder is bound; or (d) with the passage of time, the giving of notice or both, have any of the effects described in clauses (a), (b) or (c) of this Section 4.
5. Share Exchange Agreement. The Shareholder represents and warrants that the representations and warranties set forth in Section 4 of the Share Exchange Agreement applicable to such Shareholder as a Seller are true and correct in all respects as of the date hereof.
6. Amendments. No amendment or waiver of any provision of this Joinder Agreement, nor any consent or approval to any departure therefrom, shall in any event be effective unless the same shall be in writing and signed by the parties hereto.
7. Remedies Cumulative; Specific Performance. Section 9.9 of the Share Exchange Agreement is hereby incorporated by reference into this Joinder Agreement
8. Governing Law; Venue; Waiver of Jury Trial. Section 9.10 of the Share Exchange Agreement is hereby incorporated by reference into this Joinder Agreement.
9. Counterparts and Exchanges by Electronic Transmission or Facsimile. This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts and by facsimile or electronic (i.e., PDF) transmission, each of which when executed will be deemed to be an original but all of which taken together will constitute one and the same agreement.
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IN WITNESS WHEREOF, the Shareholder has caused this Joinder Agreement to be duly executed as of the date set forth below.
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EXHIBIT H
SAMPLE NET CASH CALCULATION
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EXHIBIT I
CLOSING ARTICLES OF ASSOCIATION
Company No. 11532458
THE COMPANIES ACT 2006
PRIVATE COMPANY LIMITED BY SHARES
ARTICLES OF ASSOCIATION
OF
F-STAR THERAPEUTICS LIMITED
(Adopted by special resolution passed on 2020)
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INTRODUCTION
1 |
Definitions and interpretation |
1.1 |
In these articles, unless the context requires otherwise: |
alternate or alternate director has the meaning given in article 20;
appointor has the meaning given in article 20;
articles means the companys articles of association for the time being in force;
associated company means any subsidiary or holding company of the company or any other subsidiary of the companys holding company;
business day means any day (other than a Saturday, Sunday or public holiday in England) on which clearing banks in the City of London are ordinarily open for the transaction of normal banking business;
CA 2006 means the Companies Act 2006;
Conflict has the meaning given in article 13.2;
eligible director means a director who would be entitled to vote on the matter at a meeting of directors (but excluding any director whose vote is not to be counted in respect of the particular matter);
group company means a subsidiary undertaking or parent undertaking of the company, or a subsidiary undertaking of any parent undertaking of the company;
Investors means AESCAP, Atlas, Merck, Novo Holdings A/S (including Novo), MPH, S. R. One, and TVM;
Model Articles means the model articles for private companies limited by shares contained in Schedule 1 of The Companies (Model Articles) Regulations 2008 (SI 2008/3229) as amended prior to the date of adoption of these articles;
Parent Company means F-Star Therapeutics, Inc.;
qualifying person has the meaning given in article 31.3; and
relevant officer means any director or other officer or former director or other officer of the company or an associated company, but excluding in each case any person engaged by the company (or associated company) as auditor (whether or not he is also a director or other officer), to the extent he acts in his capacity as auditor.
1.2 |
Save as otherwise specifically provided in these articles, words and expressions which have particular meanings in the Model Articles have the same meanings in these articles, subject to which and unless the context otherwise requires, words and expressions which have particular meanings in the CA 2006 have the same meanings in these articles. |
1.3 |
Headings in these articles are used for convenience only and shall not affect the construction or interpretation of these articles. |
1.4 |
A reference in these articles to an article is a reference to the relevant article of these articles unless expressly provided otherwise. |
1.5 |
Unless expressly provided otherwise, a reference to a statute, statutory provision or subordinate legislation is a reference to it as it is in force from time to time, taking account of: |
1.5.1 |
any subordinate legislation made under it, whether before or after the date of adoption of these articles; and |
1.5.2 |
any amendment or re-enactment, whether before or after the date of adoption of these articles and includes any statute, statutory provision or subordinate legislation which it amends or re-enacts. |
This article 1.5 shall not apply to the definition of Model Articles in article 1.1
1.6 |
Any phrase introduced by the terms including, include, in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms. |
1.7 |
A reference in these articles to a subsidiary, holding company, undertaking, subsidiary undertaking or parent undertaking shall be construed in accordance with section 1159 and section 1162 of CA 2006. |
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1.8 |
Any words importing the singular include the plural and vice versa and words importing any gender include the other genders. |
1.9 |
The Model Articles apply to the company, except in so far as they are modified or excluded by, or are inconsistent with, these articles. |
1.10 |
Articles 7, 8, 9(1) and (3), 11(2) and (3), 13, 14(1), (2), (3) and (4), 17(2) and 17(3) 19, 27, 28, 29, 31, 44(2), 49, 52 and 53 of the Model Articles do not apply to the company. |
2 |
Liability of members |
2.1 |
The liability of the members is limited to the amount, if any, unpaid on the shares held by them. |
DIRECTORS
3 |
Directors general authority |
3.1 |
Subject to the articles, the directors are responsible for the management of the companys business, for which purpose they may exercise all the powers of the company. |
4 |
Shareholders reserve power |
4.1 |
The shareholders may, by special resolution, direct the directors to take, or refrain from taking, specified action. |
4.2 |
No such special resolution invalidates anything which the directors have done before the passing of the resolution. |
5 |
Directors may delegate |
5.1 |
Subject to the articles, the directors may delegate any of the powers which are conferred on them under the articles: |
5.1.1 |
to such person or committee; |
5.1.2 |
by such means (including by power of attorney); |
5.1.3 |
to such an extent; |
5.1.4 |
in relation to such matters or territories; and |
5.1.5 |
on such terms and conditions; as they think fit. |
5.2 |
If the directors so specify, any such delegation may authorise further delegation of the directors powers by any person to whom they are delegated. |
5.3 |
The directors may revoke any delegation in whole or part, or alter its terms and conditions. |
6 |
Committees |
6.1 |
Committees to which the directors delegate any of their powers must follow procedures which are based as far as they are applicable on those provisions of the articles which govern the taking of decisions by directors. |
6.2 |
The directors may make rules of procedure for all or any committees, which prevail over rules derived from the articles if they are not consistent with them. |
7 |
Directors to take decisions collectively |
7.1 |
The general rule about decision-making by directors is that any decision of the directors must be either a majority decision at a meeting or a decision taken in accordance with article 8. |
7.2 |
If: |
7.2.1 |
the company only has one director for the time being; and |
7.2.2 |
no provision of the articles requires it to have more than one director the general rule does not apply, and the director may (for so long as he remains the sole director) take decisions without regard to any of the provisions of the articles relating to directors decision-making. |
8 |
Unanimous decisions |
8.1 |
A decision of the directors is taken in accordance with this article when all eligible directors indicate to each other by any means that they share a common view on a matter. |
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8.2 |
Such a decision may take the form of a resolution in writing, where each eligible director has signed one or more copies of it, or to which each eligible director has otherwise indicated agreement in writing. |
8.3 |
A decision may not be taken in accordance with this article if the eligible directors would not have formed a quorum at such a meeting. |
9 |
Calling a directors meeting |
9.1 |
Any director may call a directors meeting by giving not less than five business days notice of the meeting (or such lesser notice as all the directors may agree) to the directors or by authorising the company secretary (if any) to give such notice. |
9.2 |
Notice of a directors meeting shall be given to each director in writing. |
10 |
Quorum for directors meetings |
10.1 |
Subject to article 10.2, the quorum for the transaction of business at a meeting of directors is any two eligible directors or, where there is only one director in office for the time being and no provision of the articles requires the company to have more than one director, that director. |
10.2 |
For the purposes of any meeting (or part of a meeting) held pursuant to article 13 to authorise a directors conflict, if there is only one eligible director in office other than the conflicted director(s), the quorum for such meeting (or part of a meeting) shall be one eligible director. |
11 |
Casting vote |
11.1 |
If the numbers of votes for and against a proposal at a meeting of directors are equal, the chairman or other director chairing the meeting has a casting vote. |
11.2 |
Article 11.1 shall not apply in respect of a particular meeting (or part of a meeting) if, in accordance with the articles, the chairman or other director is not an eligible director for the purposes of that meeting (or part of a meeting). |
12 |
Transactions or other arrangements with the company |
12.1 |
Subject to the provisions of CA 2006 and provided he has declared the nature and extent of any interest of his (unless the circumstances in any of sections 177(5) and 177(6) or sections 182(5) and 182(6) CA 2006 apply, in which case no disclosure is required), a director who is in any way, whether directly or indirectly, interested in an existing or proposed transaction or arrangement with the company, notwithstanding his office: |
12.1.1 |
may be a party to, or otherwise interested in, any transaction or arrangement with the company or in which the company is otherwise (directly or indirectly) interested; |
12.1.2 |
may act by himself or his firm in a professional capacity for the company (otherwise than as auditor) and he or his firm shall be entitled to remuneration for professional services as if he were not a director; |
12.1.3 |
may be a director or other officer of, or employed by, or a party to a transaction or arrangement with, or otherwise interested in, any body corporate promoted by the company or in which the company is otherwise (directly or indirectly) interested; |
12.1.4 |
shall not, save as he may otherwise agree, be accountable to the company for any benefit which he (or a person connected with him (as defined in section 252 CA 2006)) derives from any such contract, transaction or arrangement or from any such office or employment or from any interest in any such body corporate which he is permitted to hold or enter into by virtue of articles 12.1.1, 12.1.2 or 12.1.3 and no such contract, transaction or arrangement shall be liable to be avoided on the grounds of any such interest or benefit nor shall the receipt of any such remuneration or other benefit constitute a breach of his duty under section 176 CA 2006; and |
12.1.5 |
shall subject to article 13.2, be an eligible director for the purposes of any proposed decision of the directors (or committee of directors) and shall be entitled to vote at a meeting of directors (or of a committee of the directors) or participate in any unanimous decision on any matter referred to in articles 12.1.1 to 12.1.3 (inclusive) or on any resolution which in any way concerns or relates to a |
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matter in which he has, directly or indirectly, any kind of interest whatsoever and if he shall vote on any such resolution his vote shall be counted. |
12.2 |
For the purposes of this article 12, references to proposed decisions and decision-making processes include any directors meeting or part of a directors meeting. |
13 |
Directors conflicts of interest |
13.1 |
A director shall be authorised for the purposes of section 175 CA 2006 to act or continue to act as a director of the company notwithstanding that at the time of his appointment or subsequently he also holds office as a director or other officer of, or is employed by, or is otherwise interested in (including by the holding of shares), any other group company from time to time and no further authorisation under article 13.2 shall be necessary in respect of any such interest. |
13.2 |
For the purposes of section 175 CA 2006, the directors may authorise any matter proposed to them in accordance with these articles which would, if not so authorised, involve a breach of duty by a director under that section, including, without limitation, any matter which relates to a situation in which a director has, or can have, a direct or indirect interest which conflicts, or possibly may conflict, with the interests of the company (a Conflict). Any such authorisation will be effective only if: |
13.2.1 |
any requirement as to quorum at the meeting at which the matter is considered is met without counting the director in question or any other interested director; and |
13.2.2 |
the matter was agreed to without their voting or would have been agreed to if their votes had not been counted. |
The directors may (whether at the time of the giving of the authorisation or subsequently) make any such authorisation subject to any limits or conditions they may expressly impose but such authorisation is otherwise given to the fullest extent permitted. The directors may vary or terminate any such authorisation at any time, but this will not affect anything done by the director in question prior to such variation or termination, in accordance with the terms of such authorisation.
For the purposes of these articles, a conflict of interest includes a conflict of interest and duty and a conflict of duties, and interest includes both direct and indirect interests.
13.3 |
A director shall be under no duty to the company with respect to any information which he obtains or has obtained otherwise than as a director of the company and in respect of which he owes a duty of confidentiality to another person. However, to the extent that his relationship with that other person gives rise to a Conflict, this article applies only if the existence of that relationship has been authorised pursuant to article 13.1 or by the directors pursuant to article 13.2. In particular, the director shall not be in breach of the general duties he owes to the company by virtue of sections 171 to 177 CA 2006 (inclusive) because he fails: |
13.3.1 |
to disclose any such information to the board or to any director or other officer or employee of the company; and/or |
13.3.2 |
to use or apply any such information in performing his duties as a director of the company. |
13.4 |
Where the existence of a directors relationship with another person has been authorised pursuant to article 13.1 or by the directors pursuant to article 13.2 and his relationship with that person gives rise to a Conflict, the director shall not be in breach of the general duties he owes to the company by virtue of sections 171 to 177 CA 2006 (inclusive) because he: |
13.4.1 |
absents himself from meetings of the board at which any matter relating to the Conflict will or may be discussed or from the discussion of any such matter at a meeting or otherwise; and/or |
13.4.2 |
makes arrangements not to receive documents and information relating to any matter which gives rise to the Conflict sent or supplied by the company and/or for such documents and information to be received and read by a professional adviser, for so long as he reasonably believes such Conflict subsists. |
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13.5 |
The provisions of articles 13.3 and 13.4 are without prejudice to any equitable principle or rule of law which may excuse the director from: |
13.5.1 |
disclosing information, in circumstances where disclosure would otherwise be required under these articles; or |
13.5.2 |
attending meetings or discussions or receiving documents and information as referred to in article 13.4, in circumstances where such attendance or receipt of such documents and information would otherwise be required under these articles. |
13.6 |
A director is not required, by reason of being a director (or because of the fiduciary relationship established by reason of being a director), to account to the company for any remuneration, profit or other benefit which he derives from or in connection with a relationship involving a Conflict which has been authorised in accordance with article 13.1 or by the directors pursuant to article 13.2 or by the company in general meeting (subject in each case to any terms, limits or conditions attaching to that authorisation) and no contract shall be liable to be avoided on such grounds. |
14 |
Records of decisions to be kept |
14.1 |
Where decisions of the directors are taken by electronic means, such decisions shall be recorded by the directors in permanent form, so that they may be read with the naked eye. |
15 |
Number of directors |
15.1 |
Unless otherwise determined by notice given by the Parent Company, the number of directors (other than alternate directors) shall not be subject to any maximum but shall not be less than one. A sole director shall have all the powers, duties and discretions conferred on or vested in the directors by these articles. |
16 |
Methods of appointing directors |
16.1 |
Any person who is willing to act as a director, and is permitted by law to do so, may be appointed to be a director: |
16.1.1 |
by notice given by the Parent Company pursuant to article 37; or |
16.1.2 |
by ordinary resolution; or |
16.1.3 |
by a decision of the directors. |
17 |
Termination of directors appointment |
17.1 |
Article 18 of the Model Articles is amended by: |
17.1.1 |
the insertion of the words as director after the words resigning from office, in paragraph (f); and |
17.1.2 |
the insertion of the words a notice in writing is served on the director and the company by the Parent Company pursuant to article 37 removing that person from office as director. as a new paragraph (g) at the end of that article. |
18 |
Directors remuneration |
18.1 |
Directors may undertake any services for the company that the Parent Company decides. |
18.2 |
Directors are entitled to such remuneration as the Parent Company determines: |
18.2.1 |
for their services to the company as directors; and |
18.2.2 |
for any other service which they undertake for the company. |
18.3 |
Subject to the articles, a directors remuneration may: |
18.3.1 |
take any form; and |
18.3.2 |
include any arrangements in connection with the payment of a pension, allowance or gratuity, or any death, sickness or disability benefits, to or in respect of that director. |
18.4 |
Unless the Parent Company decides otherwise, directors remuneration accrues from day to day. |
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19 |
Directors expenses |
19.1 |
Article 20 of the Model Articles is amended by: |
19.1.1 |
the deletion of the word may and insertion of the word shall in its place before the words pay any reasonable expenses; and |
19.1.2 |
the insertion of the words [(including alternate directors)] and the company secretary (if any) before the words properly incur. |
20 |
Appointment and removal of alternate directors |
20.1 |
Any director (appointor) may appoint as an alternate any other director, or any other person approved by notice in writing by the Parent Company, to: |
20.1.1 exercise that directors powers; and
20.1.2 carry out that directors responsibilities in relation to the taking of decisions by the directors, in the absence of the alternates appointor.
20.2 |
Any appointment or removal of an alternate must be effected by notice in writing to the company (marked for the attention of the chairman or company secretary (if any)) signed by the appointor, or in any other manner approved by the directors. |
20.3 |
The notice must: |
20.3.1 |
identify the proposed alternate; and |
20.3.2 |
in the case of a notice of appointment, contain a statement signed by the proposed alternate that he is willing to act as the alternate of the director giving the notice. |
21 |
Rights and responsibilities of alternate directors |
21.1 |
An alternate director may act as alternate director to more than one director and has the same rights in relation to any decision of the directors as the alternates appointor. |
21.2 |
Except as the articles specify otherwise, alternate directors: |
21.2.1 |
are deemed for all purposes to be directors; |
21.2.2 |
are liable for their own acts and omissions; |
21.2.3 |
are subject to the same restrictions as their appointors; and |
21.2.4 |
are not deemed to be agents of or for their appointors and, in particular (without limitation), each alternate director shall be entitled to receive notice of all meetings of directors and of all meetings of committees of directors of which his appointor is a member. |
21.3 |
A person who is an alternate director but not, in the absence of such appointment, a director: |
21.3.1 |
may be counted as participating for the purposes of determining whether a quorum is present (but only if that persons appointor is not participating); |
21.3.2 |
may participate in a unanimous decision of the directors (but only if his appointor is an eligible director in relation to that decision, but does not participate); and |
21.3.3 |
shall not be counted as more than one director for the purposes of articles 21.3.1 and 21.3.2. |
21.4 |
A director who is also an alternate director is entitled, in the absence of his appointor, to a separate vote on behalf of his appointor, in addition to his own vote on any decision of the directors (provided that his appointor is an eligible director in relation to that decision). |
21.5 |
An alternate director may be paid expenses and may be indemnified by the company to the same extent as his appointor but is not entitled to receive any remuneration from the company for serving as an alternate director except such part of the alternates appointors remuneration as the appointor may direct by notice in writing made to the company. |
22 |
Termination of alternate directorship |
22.1 |
An alternate directors appointment as an alternate terminates: |
22.1.1 |
when the alternates appointor revokes the appointment by notice to the company in writing (marked for the attention of the chairman or company secretary (if any)) specifying when it is to terminate; |
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22.1.2 |
on the occurrence, in relation to the alternate, of any event which, if it occurred in relation to the alternates appointor, would result in the termination of the appointors appointment as a director; |
22.1.3 |
on the death of the alternates appointor; |
22.1.4 |
when the alternates appointors appointment as a director terminates; or |
22.1.5 |
when the Parent Company revokes the appointment by notice to the alternate, the alternates appointor and the company in writing. |
23 |
Secretary |
23.1 |
Subject to the prior approval in writing by the Parent Company, the directors may appoint any person who is willing to act as the secretary for such term, at such remuneration and upon such conditions as they may think fit and from time to time remove such person and to appoint a replacement, in each case by a decision of the directors. |
SHARES AND DISTRIBUTIONS
24 |
Directors authority to allot shares |
24.1 |
Save to the extent authorised by these articles, or authorised from time to time by the Parent Company, the directors shall not exercise any power to allot shares or to grant rights to subscribe for, or to convert any security into, any shares in the company. |
25 |
Exclusion of statutory pre-emption rights |
25.1 |
Pursuant to section 567 CA 2006, the provisions of section 561 CA 2006 (existing shareholders right of pre-emption) and section 562 CA 2006 (communication of pre-emption offers to shareholders) shall not apply to an allotment of equity securities (as defined in section 560 CA 2006) made by the company. |
26 |
Replacement share certificates |
26.1 |
In article 25(2)(c) of the Model Articles, the words evidence, indemnity and the payment of a reasonable fee are deleted and replaced with the words evidence and indemnity. |
27 |
Share transfers |
27.1 |
Article 26 of the Model Articles is amended by the deletion of paragraph (5) of that article and the insertion in its place of the following: |
(5) No shareholder shall transfer any share except with the prior consent in writing of the Parent Company.
(6) The directors shall register any duly stamped transfer made in accordance with this article and shall not have any discretion to register any transfer of shares which has not been made in compliance with this article.
28 |
Drag Rights |
Share Exchange Agreement
28.1 |
In this Article 28, references to the SEA are to the Share Exchange Agreement proposed to be made between the Company, the Sellers (as defined in the SEA) and a NASDAQ listed entity (Buyer) and (save as defined in this Article) terms defined in the SEA shall have the meanings in this Article.1 |
28.2 |
Notwithstanding any other provisions in these Articles, if the Company issues any shares (other than to Buyer, any subsidiary of Buyer, any parent undertaking of Buyer or any subsidiary of such parent undertaking, or any nominee of Buyer (each a Buyer Company)) on or after the date the SEA is executed by the parties thereto and becomes effective (SEA Record Time), and prior to Closing, such shares shall be issued subject to the terms of the SEA and the holder or holders of such shares shall be bound by the SEA accordingly as a Seller thereunder. |
28.3 |
Notwithstanding any other provision of these Articles, as set out in Article 28.2 and in accordance with (and subject to) the terms of the SEA, any shares issued by the Company to any person (other than a Buyer |
1 |
If the SEA is entered into, a copy of the SEA will be published here: https://www.sec.gov/cgi-bin/browse-edgar?action=getcurrent |
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Company) after the SEA Record Time (a New Member) (each a Post-SEA Share) shall be issued on terms that they shall on the Closing Date (as defined in the SEA) or, if later, on issue, be immediately transferred to Buyer (or such other person as it may direct) (the Purchaser), who shall be obliged to acquire each Post-SEA Share in consideration for and conditional upon the issue to the New Member of the Acquisition Consideration as if such New Member had been a party to the SEA as a Seller thereunder and as if each Post-SEA Share is or was (as applicable) an F-Star Share at the SEA Record Time. |
28.4 |
To give effect to any transfer of Post-SEA Shares required pursuant to Article 28.3, the Company may appoint any person as attorney and/or agent for the New Member to transfer the Post-SEA Shares to the Purchaser and/or its nominees and do all such other things and execute and deliver all such documents or deeds as may in the opinion of such attorney or agent be necessary or desirable to vest the Post-SEA Shares in the Purchaser and pending such vesting to exercise all such rights attaching to the Post-SEA Shares as the Purchaser may direct. If an attorney or agent is so appointed, the New Member shall not thereafter (except to the extent that the attorney or agent fails to act in accordance with the directions of the Purchaser) be entitled to exercise any rights attaching to the Post-SEA Shares unless so agreed in writing by the Purchaser. The attorney or agent shall be empowered to execute and deliver as transferor a form of transfer or instructions of transfer on behalf of the New Member (or any subsequent holder) in favour of the Purchaser and the Company may give a good receipt for the consideration for the Post-SEA Shares and may register the Purchaser as holder thereof and issue to it certificate for the same. The Company shall not be obliged to issue a certificate to the New Member for the Post-SEA Shares. The Purchaser shall issue such number of Company Common Stock as is required to be issued to the New Member in consideration for such transfer as soon as practicable and in any event no later than 14 days after the date on which the Post-SEA Shares are issued to the New Member. This Article shall not apply to the Investors. |
28.5 |
If the SEA shall not have become effective by the applicable date referred to in (or otherwise set in accordance with) section 1.2 of the SEA, this Article 28 shall cease to be of any effect. |
28.6 |
Subject to Article 28.5 but notwithstanding any other provision of these Articles, following the SEA Record Time, no Shares shall be transferred by any Shareholder without the consent of the Buyer (acting reasonably) other than to the Purchaser and/or its nominees pursuant to the SEA, and both the Company and the board shall refuse to register the transfer of any Shares effected without such consent. |
29 |
Payment of dividends and other distributions |
29.1 |
Where a dividend or other sum which is a distribution is payable in respect of a share, it shall be paid by: |
29.1.1 |
such method of payment as the Parent Company shall by notice to the directors direct in accordance with article 37; or |
29.1.2 |
any other means of payment as the directors may agree with the distribution recipient in writing. |
29.2 |
In the articles, distribution recipient means, in respect of a share in respect of which a dividend or other sum is payable: |
29.2.1 |
the holder of the share; or |
29.2.2 |
if the share has two or more joint holders, whichever of them is named first in the register of members. |
30 |
Authority to capitalise and appropriation of capitalised sums |
30.1 |
Article 36(1) of the Model Articles is amended by the deletion of the words an ordinary resolution and the insertion in their place of the words the Parent Company by notice in writing in accordance with article 37. |
DECISION MAKING BY SHAREHOLDERS
31 |
Quorum for general meetings |
31.1 |
If the company has only one shareholder, one qualifying person present at a meeting is a quorum. |
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31.2 |
If the company has more than one shareholder, two qualifying persons present at a meeting are a quorum, unless each is a representative of a corporation or each is appointed as proxy of a shareholder and they are representatives of the same corporation or are proxies of the same shareholder. |
31.3 |
For the purposes of these articles, a qualifying person is: |
31.3.1 |
an individual who is a shareholder of the company; |
31.3.2 |
a person authorised to act as the representative of a corporation in relation to the meeting; or |
31.3.3 |
a person appointed as proxy of a shareholder in relation to the meeting. |
32 |
Poll votes |
32.1 |
A poll may be demanded at any general meeting by any qualifying person present and entitled to vote at the meeting. |
32.2 |
Article 44(3) of the Model Articles is amended by the insertion of the words A demand so withdrawn shall not invalidate the result of a show of hands declared before the demand was made. as a new paragraph at the end of that article. |
33 |
Proxies |
33.1 |
Article 45(1)(d) of the Model Articles is deleted and replaced with the words is delivered to the company in accordance with the articles not less than 48 hours before the time appointed for holding the meeting or adjourned meeting at which the right to vote is to be exercised and in accordance with any instructions contained in the notice of the general meeting (or adjourned meeting) to which they relate. |
33.2 |
Article 45(1) of the Model Articles is amended by the insertion of the words and a proxy notice which is not delivered in such manner shall be invalid, unless the directors, in their discretion, accept the notice at any time before the meeting. as a new paragraph at the end of that article. |
ADMINISTRATIVE ARRANGEMENTS
34 |
Service of notices and other documents |
34.1 |
Subject to articles 34.2 and 34.3, any notice, document or other information shall be deemed served on, or delivered to, the intended recipient: |
34.1.1 |
if delivered by hand, on signature of a delivery receipt or at the time the notice, document or other information is left at the address; or |
34.1.2 |
if sent by fax, at the time of transmission; or |
34.1.3 |
if sent by pre-paid United Kingdom first class post, Signed For recorded delivery or Special Delivery Guaranteed to an address in the United Kingdom, at 9.00 am on the second business day after posting; or |
34.1.4 |
if sent by pre-paid international airmail to an address outside the country from which it is sent, at 9.00 am on the fifth business day after posting; or |
34.1.5 |
if sent by reputable international overnight courier to an address outside the country from which it is sent, on signature of a delivery receipt or at the time the notice, document or other information is left at the address; or |
34.1.6 |
if sent or supplied by e-mail, one hour after the notice, document or information was sent or supplied; or |
34.1.7 |
if sent or supplied by means of a website, when the material is first made available on the website or (if later) when the recipient receives (or is deemed to have received) notice of the fact that the material is available on the website; and |
34.1.8 |
if deemed receipt under the previous paragraphs of this article 34.1 would occur outside business hours (meaning 9.00 am to 5.30 pm Monday to Friday on a day that is not a public holiday in the place of deemed receipt), at 9.00 am on the day when business next starts in the place of deemed receipt. For the purposes of this article, all references to time are to local time in the place of deemed receipt. |
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34.2 |
To prove service, it is sufficient to prove that: |
34.2.1 |
if delivered by hand or by reputable international overnight courier, the notice was delivered to the correct address; or |
34.2.2 |
if sent by fax, a transmission report was received confirming that the notice was successfully transmitted to the correct fax number; or |
34.2.3 |
if sent by post or by international airmail, the envelope containing the notice was properly addressed, paid for and posted; or |
34.2.4 |
if sent by e-mail, the notice was properly addressed and sent to the e-mail address of the recipient. |
34.3 |
In proving that any notice, document or other information was properly addressed, it shall be sufficient to show that the notice, document or other information was addressed to an address permitted for the purpose by CA 2006. |
35 |
Indemnity |
35.1 |
Subject to the provisions of, and so far as may be consistent with, the Companies Acts and any other provision of law, but without prejudice to any indemnity to which a relevant officer may otherwise be entitled, the company shall indemnify every relevant officer out of the companys assets against all costs, charges, losses, expenses and liabilities incurred by him as a relevant officer in the actual or purported execution and/or discharge of his duties and/or the actual or purported exercise of his powers and/or otherwise in relation to or in connection with his duties, powers or office, including (without prejudice to the generality of the foregoing) any liability incurred by him in relation to any proceedings (whether civil or criminal) or any regulatory investigation or action which relate to anything done or omitted or alleged to have been done or omitted by him as a relevant officer provided that, in the case of any director, any such indemnity shall not apply to any liability of that director: |
35.1.1 |
to the company or to any of its associated companies; |
35.1.2 |
to pay any fine imposed in criminal proceedings or any sum payable to a regulatory authority by way of penalty in respect of non-compliance with any requirement of a regulatory nature (however arising); or |
35.1.3 |
incurred: |
(i) in defending any criminal proceedings in which he is convicted or any civil proceedings brought by the company, or any of its associated companies, in which judgment is given against him; or
(ii) in connection with any application under any statute for relief from liability in respect of any such act or omission in which the court refuses to grant him relief, in each case where the conviction, judgment or refusal of relief by the court is final within the meaning stated in section 234(5) CA 2006.
35.2 |
Subject to the provisions of, and so far as may be consistent with, the Companies Acts and any other provision of law, every director shall be entitled to have funds provided to him by the company to meet expenditure incurred or to be incurred in connection with any proceedings (whether civil or criminal)[, investigation or action] brought by any party which relate to anything done or omitted or alleged to have been done or omitted by him as a director, provided that he will be obliged to repay such amounts no later than: |
35.2.1 |
in the event he is convicted in proceedings, the date when the conviction becomes final; |
35.2.2 |
in the event of judgment being given against him in proceedings, the date when the judgment becomes final; or |
35.2.3 |
in the event of the court refusing to grant him relief on any application under any statute for relief from liability, the date when refusal becomes final in each case where the conviction, judgment or refusal of relief by the court is final within the meaning stated in section 234(5) CA 2006. |
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36 |
Insurance |
36.1 |
The directors shall purchase and maintain insurance, at the expense of the company, for the benefit of any relevant officer in respect of any relevant loss. |
36.2 |
In this article a relevant loss means any loss or liability which has been or may be incurred by a relevant officer in connection with that relevant officers duties or powers in relation to the company, any associated company or any pension fund or employees share scheme of the company or associated company. |
OVERRIDING PROVISIONS
37 |
Matters requiring Parent Company consent |
37.1 |
Whenever the Parent Company, or any subsidiary of the Parent Company, shall be the holder of not less than 90% of the issued ordinary shares of the company, the following provisions shall apply and to the extent of any inconsistency shall have overriding effect as against all other provisions of these articles. |
37.2 |
The Parent Company may at any time and from time to time: |
37.2.1 |
appoint any person to be a director of the company or remove from office any director howsoever appointed but so that in the case of a managing director or a director appointed to any other executive office his removal from office shall be deemed an act of the company and shall have effect without prejudice to any claim for damages for breach of any contract of service between him and the company; |
37.2.2 |
impose restrictions on all or any of the powers of the directors to such extent as the Parent Company may by notice to the company prescribe. |
37.3 |
Any appointment, removal or notice of the Parent Company made or given under this article 37 shall be in writing served on the company and signed on behalf of the Parent Company by any one of its directors or by its company secretary (if any) or by some other person duly authorised for the purpose. |
No person dealing with the company shall be concerned to see or enquire whether the powers of the directors have been in any way restricted pursuant to these articles or whether any requisite consent of the Parent Company has been obtained and no obligation incurred or security given or transaction effected by the company to or with any third party shall be invalid or ineffectual unless the third party has at the time express notice that the incurring of such obligation or the giving of such security or the effecting of such transaction was in excess of the powers of the directors.
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EXHIBIT J
SAMPLE EXCHANGE RATIO CALCULATION
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ANNEX B OPINION OF LADENBURG THALMANN & CO., INC.
Strictly Confidential
July 27, 2020
Spring Bank Pharmaceuticals, Inc.
Attention: Board of Directors
35 Parkwood Drive, Suite 210
Hopkinton, MA 01748
Members of the Board of Directors:
We have been advised that Spring Bank Pharmaceuticals, Inc. (Spring Bank or the Company), proposes to enter into a Share Exchange Agreement (the Exchange Agreement), by and among Spring Bank, a Delaware corporation, F-star Therapeutics Ltd., a company registered in England and Wales with company number 11532458 (F-star), and the Sellers named therein or who become Sellers after the date of the Exchange Agreement (the Sellers). Pursuant to the Exchange Agreement, the Sellers will receive for each F-star Share issued and outstanding immediately prior to the Closing (including F-star Ordinary Shares issued pursuant to the F-star Pre-Closing Financing) a number of duly authorized, validly issued, fully paid and non-assessable shares of Company Common Stock as is equal to the Exchange Ratio (determined as provided in the Exchange Agreement and subject to adjustment as provided therein). Assuming that F-star receives gross proceeds of $25.0 million in the F-star Pre-Closing Financing and the Companys Net Cash equals $16.0 million, the Exchange Ratio would be 0.5269, such that, following the consummation of the Acquisition, the holders of F-star Shares immediately prior to the Acquisition will hold approximately 61.2% of Company Common Stock outstanding immediately following the Acquisition and the holders of Spring Bank Common Stock immediately prior to the Acquisition are expected to hold approximately 38.8% of Company Common Stock outstanding immediately following the Acquisition. We further understand that the Company Stockholders as of immediately prior to the Closing will receive two contingent value rights related to the STING antagonist and STING agonist (the CVRs) pursuant to the Contingent Value Right Agreements, which would be executed in connection with the consummation of the Acquisition (the CVR Agreements). The Acquisition Consideration (the Acquisition Consideration) referred to herein consists only of the Exchange Ratio and does not include the CVRs. The terms and conditions of the Acquisition are more fully set forth in the Exchange Agreement and the CVR Agreements. Capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Exchange Agreement or the CVR Agreements, as the case may be.
In your capacity as members of the Board of Directors (the Board of Directors) of Spring Bank, you have requested our opinion (our Opinion), as to the fairness, from a financial point of view and as of the date hereof, of the Acquisition Consideration to the Company Stockholders.
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Spring Bank Pharmaceuticals, Inc. |
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July 27, 2020 |
In connection with our Opinion, we took into account an assessment of general economic, market and financial conditions as well as our experience in connection with similar transactions and securities valuations generally and, among other things:
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Reviewed a draft of the Exchange Agreement dated July 26, 2020, and a draft of the CVR Agreements. Both the Exchange Agreement and the CVR Agreements were the most recent drafts made available to us prior to delivery of our Opinion; |
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Reviewed and analyzed certain publicly available financial and other information for each of Spring Bank and F-star, respectively, including equity research on comparable companies and on Spring Bank, and certain other relevant financial and operating data furnished to us by the management of each of Spring Bank and F-star, respectively; |
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Reviewed and analyzed certain relevant historical financial and operating data concerning F-star furnished to us by the management of F-star; |
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Discussed with certain members of the management of Spring Bank the historical and current business operations, financial condition and prospects of Spring Bank; |
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Reviewed and analyzed certain operating results of F-star as compared to operating results and the reported price and trading histories of certain publicly traded companies that we deemed relevant; |
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Reviewed and analyzed certain financial terms of the Exchange Agreement and the CVR Agreements as compared to the publicly available financial terms of certain selected business combinations that we deemed relevant; |
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Reviewed and analyzed certain financial terms of completed initial public offerings for certain companies that we deemed relevant; |
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Reviewed certain pro forma financial effects of the Acquisition; and |
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Reviewed and analyzed such other information and such other factors, and conducted such other financial studies, analyses and investigations, as we deemed relevant for the purposes of our Opinion. |
In conducting our review and arriving at our Opinion, we have, with your consent, assumed and relied, without independent verification or investigation, upon the accuracy and completeness of all financial and other information provided to or discussed with us by Spring Bank and F-star, respectively (or their respective employees, representatives or affiliates), or which is publicly available or was otherwise reviewed by us. We have not undertaken any responsibility for the accuracy, completeness or reasonableness of, or independent verification of, such information. We have relied upon, without independent verification, the assessment of Spring Bank management and F-star management as to the viability of, and risks associated with, the current and future products and services of F-star (including without limitation, the development, testing and marketing of such products and services, the receipt of all necessary governmental and other regulatory approvals for the development, testing and marketing thereof, and the life and enforceability of all relevant patents and other intellectual and other property rights associated with such products and services). In addition, we have not conducted, nor have we assumed any obligation to conduct, any physical inspection of the properties or facilities of Spring Bank or F-star. Furthermore, we have assumed, with your consent, that there will be no adjustment to the Acquisition Consideration between the date hereof and the date the final Acquisition Consideration is determined. We have, with your consent, relied upon the assumption that all information provided to us by Spring Bank and F-star is accurate and complete in all material respects. We expressly disclaim any undertaking or obligation to advise any person of any change in any fact or matter affecting our Opinion of which we become
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Spring Bank Pharmaceuticals, Inc. |
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July 27, 2020 |
aware after the date hereof. We assumed there were no material changes in the assets, liabilities, financial condition, results of operations, business or prospects of Spring Bank or F-star since the date of the last financial statements made available to us. We have not obtained any independent evaluations, valuations or appraisals of the assets or liabilities of Spring Bank or F-star, nor have we been furnished with such materials. In addition, we have not evaluated the solvency or fair value of Spring Bank or F-star under any state or federal laws relating to bankruptcy, insolvency or similar matters. Our Opinion does not address any legal, tax or accounting matters related to the Acquisition, as to which we have assumed that Spring Bank and the Board of Directors have received such advice from legal, tax and accounting advisors as each has determined appropriate. Our Opinion addresses only the fairness of the Acquisition Consideration, from a financial point of view, to the Company Stockholders. We express no view as to any other aspect or implication of the Acquisition or any other agreement or arrangement entered into in connection with the Acquisition. Our Opinion is necessarily based upon economic and market conditions and other circumstances as they exist and can be evaluated by us on the date hereof. It should be understood that although subsequent developments may affect our Opinion, we do not have any obligation to update, revise or reaffirm our Opinion and we expressly disclaim any responsibility to do so.
Ladenburg Thalmann & Co. Inc. (Ladenburg) did not assign any value to the right of the Company Stockholders to receive contingent cash payments per the CVR Agreements, given our determination that any assumptions as to the probability of payment of the CVRs would be too speculative to use in our analysis of the value of such rights.
We have not considered any potential legislative or regulatory changes currently being considered or recently enacted by the United States or any foreign government, or any domestic or foreign regulatory body, or any changes in accounting methods or generally accepted accounting principles that may be adopted by the Securities and Exchange Commission, the Financial Accounting Standards Board, or any similar foreign regulatory body or board.
For purposes of rendering our Opinion we have assumed in all respects material to our analysis, that the representations and warranties of each party contained in the Exchange Agreement are true and correct, that each party will perform all of the standards of the covenants and agreements required to be performed by it under the Exchange Agreement and CVR Agreements and that all conditions to the consummation of the Acquisition will be satisfied without waiver thereof. We have assumed that the final form of the Exchange Agreement and the CVR Agreements will be substantially similar to the last draft reviewed by us. We have also assumed that all governmental, regulatory and other consents and approvals contemplated by the Exchange Agreement and the CVR Agreements will be obtained and that in the course of obtaining any of those consents no restrictions will be imposed or waivers made that would have an adverse effect on the contemplated benefits of the Acquisition. We have assumed that the Acquisition will be consummated in a manner that complies with the applicable provisions of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and all other applicable federal and state statutes, rules and regulations. You have informed us, and we have assumed, that the Acquisition is intended to constitute a reorganization within the meaning of Section 360(a) of the Code and the Treasury Regulations promulgated thereunder.
It is understood that this letter is intended for the benefit and use of the Board of Directors and the Board of Directors in its consideration of the financial terms of the Acquisition and, except as set forth in the engagement letter with Spring Bank, dated as of March 20, 2020 (the Engagement Letter), may not be used for any other purpose or reproduced, disseminated, quoted or referred to at any time, in any manner or for any purpose without our prior written consent, unless pursuant to applicable law or regulations or required by other regulatory
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Spring Bank Pharmaceuticals, Inc. |
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July 27, 2020 |
authority by the order or ruling of a court or administrative body, except that this opinion may be included in its entirety in any filing related to the Acquisition to be filed with the Securities and Exchange Commission and the proxy statement to be mailed to the Company Stockholders. This letter does not constitute a recommendation to the Board of Directors of whether or not to approve the Acquisition or to any Company Stockholders or any other person as to how to vote with respect to the Acquisition or to take any other action in connection with the Acquisition or otherwise. Our Opinion does not address Spring Banks underlying business decision to proceed with the Acquisition or the relative merits of the Acquisition compared to other alternatives available to Spring Bank. We express no opinion as to the prices or ranges of prices at which shares or the securities of any person, including Spring Bank, will trade at any time, including following the announcement or consummation of the Acquisition. We have not been requested to opine as to, and our Opinion does not in any manner address, the amount or nature of compensation to any of the officers, directors or employees of any party to the Acquisition, or any class of such persons, relative to the compensation to be paid to the Company Stockholders in connection with the Acquisition or with respect to the fairness of any such compensation.
Ladenburg is a full service investment bank providing investment banking, brokerage, equity research, institutional sales and trading, and asset management services. As part of our investment banking services, we are regularly engaged in the valuation of businesses and their securities in connection with mergers, negotiated underwritings, secondary distributions of listed and unlisted securities, private placements and valuations for corporate and other purposes. We have acted as Spring Banks financial advisor in connection with the Acquisition and will receive a fee for our services pursuant to the terms of our Engagement Letter, a significant portion of which is contingent upon consummation of the Acquisition. In addition, Spring Bank has agreed to reimburse our expenses and indemnify us for certain liabilities that may arise out of our engagement. We will also receive an additional fee for rendering our Opinion set forth below pursuant to the Engagement Letter. In the two years preceding the date hereof, Ladenburg has not had a relationship with Spring Bank and has not received any fees from Spring Bank, aside from the $150,000 up-front retainer which was paid to Ladenburg in connection with its engagement. In the two years preceding the date hereof, Ladenburg has not had a relationship with F-star and has not received any fees from F-star. Ladenburg and its affiliates may in the future seek to provide investment banking or financial advisory services to Spring Bank and F-star and/or certain of their respective affiliates and expect to receive fees for the rendering of these services.
In the ordinary course of business, Ladenburg or certain of our affiliates, as well as investment funds in which we or our affiliates may have financial interests, may acquire, hold or sell long or short positions, or trade or otherwise effect transactions in debt, equity, and other securities and financial instruments (including bank loans and other obligations) of, or investments in, Spring Bank, F-star or any other party that may be involved in the Acquisition and/or their respective affiliates.
Consistent with applicable legal and regulatory requirements, Ladenburg has adopted policies and procedures to establish and maintain the independence of our research department and personnel. As a result, our research analysts may hold views, make statements or investment recommendations and/or publish research reports with respect to Spring Bank and the proposed Acquisition that may differ from the views of Ladenburgs investment banking personnel.
The Opinion set forth below was reviewed and approved by a fairness opinion committee of Ladenburg.
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Spring Bank Pharmaceuticals, Inc. |
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July 27, 2020 |
Based upon and subject to the foregoing, including the various assumptions and limitations set forth herein and such other factors that we deem relevant, it is our opinion that, as of the date hereof, the Acquisition Consideration is fair, from a financial point of view, to the Company Stockholders.
Very truly yours, |
/s/ Ladenburg Thalmann & Co. Inc. |
Ladenburg Thalmann & Co. Inc. |
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ANNEX C CERTIFICATE OF AMENDMENT FOR THE REVERSE STOCK SPLIT
CERTIFICATE OF AMENDMENT
TO THE
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
SPRING BANK PHARMACEUTICALS, INC.
SPRING BANK PHARMACEUTICALS, INC., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the DGCL), does hereby certify:
FIRST: The name of the corporation is Spring Bank Pharmaceuticals, Inc. (the Corporation).
SECOND: The Corporation was incorporated under the name Spring Bank Pharmaceuticals, Inc. pursuant to an original Certificate of Incorporation filed with the Secretary of State of the State of Delaware (the Delaware Secretary) on May 12, 2008. An Amended and Restated Certificate of Incorporation was duly adopted in accordance with Sections 242 and 245 of the DGCL on May 11, 2016.
THIRD: The Board of Directors (the Board) of the Corporation, acting in accordance with the provisions of Sections 141 and 242 of the DGCL, adopted resolutions amending its Certificate of Incorporation as follows:
RESOLVED, that Article FOURTH of the Amended and Restated Certificate of Incorporation, as presently in effect, of the Corporation is amended to add the following to the end of Section (a):
Immediately upon filing of this Certificate of Amendment to the Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware (the Effective Time), the shares of the Corporations Common Stock, par value $0.0001 per share, issued and outstanding immediately prior to the Effective Time and the shares of Common Stock issued and held in the treasury of the Corporation immediately prior to the Effective Time shall be combined into a smaller number of shares such that each , as determined by the Board, shares of issued and outstanding Common Stock immediately prior to the Effective Time are combined into one validly issued, fully paid and nonassessable share of Common Stock, par value $0.0001 per share (the Reverse Split). Notwithstanding the immediately preceding sentence, no fractional shares shall be issued and, in lieu thereof, upon surrender after the Effective Time of a certificate which formerly represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time, any person who would otherwise be entitled to a fractional share of Common Stock as a result of the combination, following the Effective Time (after aggregating all fractional shares of Common Stock otherwise issuable to such holder), shall be entitled to receive a cash payment equal to the fraction to which such holder would otherwise be entitled multiplied by the closing price of the Corporations Common Stock as reported on the Nasdaq Capital Market on the date of the filing of this Certificate of Amendment to the Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware (as adjusted to give effect to the Reverse Split, rounded up to the nearest whole cent).
Each stock certificate that, immediately prior to the Effective Time, represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time shall, from and after the Effective Time, automatically and without the necessity of presenting the same for exchange, represent that number of whole shares of Common Stock after the Effective Time into which the shares of Common Stock formerly represented by such certificate shall have been combined (as well as the right to receive cash in lieu of fractional shares of Common Stock after the Effective Time), provided however, that each person of record holding a certificate that represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time shall receive, upon surrender of such certificate, a new certificate evidencing and representing the number of whole shares of Common stock after the Effective Time into which the shares of Common Stock formerly represented by such certificate shall have been combined.
FOURTH: Thereafter, pursuant to a resolution by the Board, this Certificate of Amendment was submitted to the stockholders of the Corporation for their approval in accordance with the provisions of Section 211 and 242 of
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the DGCL. Accordingly, said proposed amendment has been adopted in accordance with Section 242 of the DGCL.
FIFTH: This Certificate of Amendment will be effective at immediately upon filing.
IN WITNESS WHEREOF, SPRING BANK PHARMACEUTICALS, INC. has caused this Certificate of Amendment to be signed by , its duly authorized officer on , 2020.
SPRING BANK PHARMACEUTICALS, INC. | ||
By: | ||
Name: | ||
Title: |
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ANNEX D CERTIFICATE OF AMENDMENT FOR SPRING BANK NAME CHANGE
CERTIFICATE OF AMENDMENT
TO THE
RESTATED
CERTIFICATE OF INCORPORATION
OF
SPRING BANK PHARMACEUTICALS, INC.
Spring Bank Pharmaceuticals, Inc. (the Corporation), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, as amended (the DGCL), hereby certifies as follows:
A. The name of the Corporation is Spring Bank Pharmaceuticals, Inc., and the original certificate of incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on May 12, 2008. A Restated Certificate of Incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on May 11, 2016 (the Prior Certificate). A certificate of Amendment to the Prior Certificate was filed with the Secretary of State of the State of Delaware on , 2020.
B. This Certificate of Amendment to the Restated Certificate of Incorporation (the Certificate of Amendment) amends the Prior Certificate, as amended, and has been duly adopted by the Corporations Board of Directors and stockholders in accordance with the provisions of Sections 141, 211 and 242 of the DGCL.
C. Article FIRST of the Prior Certificate, as amended, is hereby amended and restated to read as follows:
FIRST: The name of the Corporation is F-star Therapeutics, Inc.
D. The Certificate of Amendment so adopted reads in full as set forth above and is hereby incorporated by reference. All other provisions of the Prior Certificate, as amended, remain in full force and effect.
IN WITNESS WHEREOF, Spring Bank Pharmaceuticals, Inc. has caused this Certificate of Amendment to be signed by , a duly authorized officer of the Corporation, on , 2020.
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PART II
INFORMATION NOT REQUIRED IN PROXY STATEMENT/PROSPECTUS
Item 20. |
Indemnification of Directors and Officers |
Delaware Law
Section 102 of the General Corporation Law of the State of Delaware permits a corporation to eliminate the personal liability of directors of a corporation to the corporation or its stockholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit.
Section 145 of the General Corporation Law of the State of Delaware provides that a corporation has the power to indemnify a director, officer, employee, or agent of the corporation, or a person serving at the request of the corporation for another corporation, partnership, joint venture, trust or other enterprise in related capacities against expenses, including attorneys fees, judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with an action, suit or proceeding to which he was or is a party or is threatened to be made a party to any threatened, ending or completed action, suit or proceeding by reason of such position, if such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation, no indemnification will be made with respect to any claim, issue or matter as to which such person will have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court will deem proper.
Amended and Restated Certificate of Incorporation
Spring Banks amended and restated certificate of incorporation provides that Spring Bank will indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding (other than an action by or in the right of us) by reason of the fact that he or she is or was, or has agreed to become, a director or officer, or is or was serving, or has agreed to serve, at the request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (all such persons being referred to as an Indemnitee), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with such action, suit or proceeding and any appeal therefrom, if such Indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, Spring Banks best interests, and, with respect to any criminal action or proceeding, he or she had no reasonable cause to believe his or her conduct was unlawful.
Spring Banks amended and restated certificate of incorporation provides that Spring Bank will indemnify any Indemnitee who was or is a party to an action or suit by or in the right of Spring Bank to procure a judgment in Spring Banks favor by reason of the fact that the Indemnitee is or was, or has agreed to become, a director or officer, or is or was serving, or has agreed to serve, at Spring Banks request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred in connection with such action, suit or proceeding, and any appeal therefrom, if the Indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, Spring Banks best interests, except that no indemnification will be made with respect to any claim, issue or matter as to
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which such person will have been adjudged to be liable to us, unless a court determines that, despite such adjudication but in view of all of the circumstances, he or she is entitled to indemnification of such expenses. Notwithstanding the foregoing, to the extent that any Indemnitee has been successful, on the merits or otherwise, he or she will be indemnified by Spring Bank against all expenses (including attorneys fees) actually and reasonably incurred in connection therewith. Expenses must be advanced to an Indemnitee under certain circumstances.
Indemnification Agreements
Spring Bank has entered into indemnification agreements with each of its directors and officers. These indemnification agreements may require Spring Bank, among other things, to indemnify Spring Banks directors and officers for some expenses, including attorneys fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of the directors or officers, or any of the subsidiaries or any other company or enterprise to which the person provides services at Spring Banks request.
Spring Bank maintains a general liability insurance policy that covers certain liabilities of directors and officers of Spring Bank arising out of claims based on acts or omissions in their capacities as directors or officers.
Pursuant to the terms of the Exchange Agreement and subject to applicable law, from the Closing through the sixth anniversary of the date on which the Closing occurs, Spring Bank will indemnify and hold harmless the D&O Indemnified Parties against all claims, losses, liabilities, damages, judgments, fines and reasonable fees, costs and expenses, including attorneys fees and disbursements, incurred in connection with any claim, action, suit, proceeding or investigation, whether civil, criminal, administrative or investigative, arising out of or pertaining to the fact that the D&O Indemnified Party is or was a director or officer of an F-star or Spring Bank, whether asserted or claimed prior to, at or after the Closing, to the fullest extent permitted under applicable Legal Requirement (as defined in the Exchange Agreement), and the applicable companys organizational documents. Each D&O Indemnified Party will, to the fullest extent permitted under applicable Legal Requirements and the applicable companys organizational documents, be entitled to advancement of expenses incurred in the defense of any such claim, action, suit, proceeding or investigation from each applicable company, jointly and severally, upon receipt by Spring Bank or F-star from the D&O Indemnified Party of a request for such advancement; provided that any person to whom expenses are advanced provides an undertaking, to the extent then required by applicable Legal Requirement, to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
The Exchange Agreement also provides that Spring Bank will maintain directors and officers liability insurance policies commencing at the Closing, on commercially available terms and conditions and with coverage limits customary for U.S. public companies similarly situated to Spring Bank. In addition, prior to the Closing, Spring Bank will purchase and fully pre-pay (at Spring Banks expense) a tail endorsement for Spring Banks existing directors and officers insurance policies and Spring Banks existing fiduciary liability insurance policies, in each case, that provides a six-year extended reporting period from and after the Closing for claims first made against an individual insured for any alleged or actual wrongful act(s) that occurred prior to the Closing (including in connection with the Exchange Agreement or the transactions contemplated thereby).
The director and officer indemnification provisions of the Exchange Agreement are intended to be in addition to the rights otherwise available to the current and former officers and directors of Spring Bank and F-star by law, charter, statute, bylaw or agreement, and will operate for the benefit of, and will be enforceable by, each of such indemnified persons, their heirs and their representatives.
In the event that Spring Bank or F-star or any of their respective successors or assigns (i) consolidates with or merges into another entity and is not the continuing or surviving corporation or entity of such consolidation or
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merger, or (ii) transfers all or substantially all of its properties and assets to another person, then, and in each such case, proper provision will be made so that the successors and assigns of Spring Bank or F-star, as applicable, will succeed to the obligations set forth in the Exchange Agreement.
Item 21. |
Exhibits and Financial Statement Schedules |
(a) Exhibit Index
A list of exhibits filed with this registration statement on Form S-4 is set forth on the Exhibit Index and is incorporated herein by reference.
(b) Financial Statements
The financial statements filed with this registration statement on Form S-4 is set forth on the Financial Statement Index and is incorporated herein by reference.
Item 22. |
Undertakings |
(a) The undersigned registrant hereby undertakes as follows:
(1) |
That prior to any public reoffering of the securities registered hereunder through use of a prospectus which is a part of this registration statement, by any person or party who is deemed to be an underwriter within the meaning of Rule 145(c), the issuer undertakes that such reoffering prospectus will contain the information called for by the applicable registration form with respect to reofferings by persons who may be deemed underwriters, in addition to the information called for by the other items of the applicable form. |
(2) |
That every prospectus: (i) that is filed pursuant to paragraph (1) immediately preceding, or (ii) that purports to meet the requirements of Section 10(a)(3) of the Securities Act and is used in connection with an offering of securities subject to Rule 415, will be filed as a part of an amendment to the registration statement and will not be used until such amendment is effective, and that, for purposes of determining any liability under the Securities Act, each such post- effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) |
To respond to requests for information that is incorporated by reference into the prospectus pursuant to Item 4, 10(b), 11, or 13 of this form, within one business day of receipt of such request, and to send the incorporated documents by first class mail or other equally prompt means. This includes information contained in documents filed subsequent to the effective date of the registration statement through the date of responding to the request. |
(4) |
To supply by means of a post-effective amendment all information concerning a transaction, and the company being acquired involved therein, that was not the subject of and included in the registration statement when it became effective. |
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EXHIBIT INDEX
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# |
Indicates a management contract or compensatory plan, contract or arrangement. |
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Confidential treatment has been requested or granted as to certain portions, which portions have been omitted and filed separately with the SEC. |
^ |
Previously Filed. |
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Pursuant to the requirements of the Securities Act, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Hopkinton, Commonwealth of Massachusetts, on the 30th day of September, 2020.
SPRING BANK PHARMACEUTICALS, INC. |
/s/ Martin Driscoll |
Martin Driscoll |
President and Chief Executive Officer |
Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Name |
Title |
Date |
||
/s/ Martin Driscoll Martin Driscoll |
President and Chief Executive Officer
(Principal Executive Officer) |
September 30, 2020 | ||
/s/ Lori Firmani Lori Firmani |
Vice President of Finance
(Principal Financial and Accounting Officer) |
September 30, 2020 | ||
* Scott Smith |
Chairman of the Board and Director |
September 30, 2020 | ||
* David Arkowitz |
Director |
September 30, 2020 | ||
* Todd Brady, M.D., Ph.D. |
Director |
September 30, 2020 | ||
* Timothy Clackson, Ph.D. |
Director |
September 30, 2020 |
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Name |
Title |
Date |
||
* Kurt M. Eichler |
Director |
September 30, 2020 |
||
* Pamela Klein, M.D. |
Director |
September 30, 2020 |
*By: | /s/ Martin Driscoll | |
Martin Driscoll | ||
Attorney-in-fact |
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Exhibit 10.26
SPRING BANK PHARMACEUTICALS, INC.
RETENTION AND BONUS AWARD AGREEMENT
This Retention and Bonus Award Agreement (this Agreement) is made and entered into on September 9, 2020 (the Effective Date), between Spring Bank Pharmaceuticals, Inc. (the Company) and Kris Iyer (Employee).
WHEREAS, Employee occupies a key position with the Company and in order to ensure the continued effective conduct of the Companys business, the Company desires to assure itself of the continuous services of Employee;
WHEREAS, Employee is a party to an employment agreement with the Company dated December 1, 2015 (as amended, the Employment Agreement);
WHEREAS, on July 29, 2020, the Company entered into a Share Exchange Agreement (the Exchange Agreement) with F-star Therapeutics Limited (F-star), pursuant to which the Company will acquire all of the issued and outstanding share capital of F-star, with F-star remaining as the surviving company (the Transaction);
WHEREAS, pursuant to the Exchange Agreement, the Company is permitted to sell and/or license certain assets, including the Companys STING antagonist assets (the Antagonist Assets), to strengthen its cash position upon the closing of the Transaction (the Closing); and
WHEREAS, the Company desires to offer Employee a retention bonus award in an amount equal to the lesser of (i) 5% of the upfront payment from any sale or license of the Antagonist Assets that the Company receives prior to the Closing, and (ii) $50,000 (the Bonus/Retention Amount).
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the parties hereby agree as follows:
1. |
Retention Award. In the event that (i) the Company enters into an agreement for the sale or license of the Antagonist Assets prior to the Closing and (ii) the Employee remains continuously employed by the Company between the Effective Date and the Closing, then Employee shall be eligible to receive a retention award equal to the Bonus/Retention Amount (the Retention Award). If the Closing does not occur by March 31, 2021, this Agreement shall terminate in full without any further liability to the Company. The Retention Award shall be paid in a single lump sum on or within thirty (30) days following the Closing. |
2. |
Termination of Employment. Employee shall no longer be eligible for any portion of the Retention Award if Employees employment is terminated for any reason prior to the Closing; provided, however, that if the Company has entered into an agreement for the sale or license of the Antagonist Assets and the Company subsequently terminates Employees employment without Cause (as defined in the Employment Agreement) or Employee resigns from employment with Good Reason (as defined in the Employment Agreement) prior to the Closing, the Company shall pay Employee the Retention Award in a single lump sum on or within thirty (30) days following Employees termination of employment. |
3. |
Exclusion for Analogous Retention Benefits; No Effect on Severance and Other Benefits. An employee who is eligible for retention payments or benefits under any analogous retention plan, policy or agreement with the Company shall not be eligible for or entitled to receive this Agreement or any payment or benefit hereunder. This Agreement, however, shall not affect Employees eligibility or entitlement to receive any benefits payable (i) to Employee under another severance or change of control plan, policy or agreement with the Company or (ii) to Employee under that certain Retention Award Agreement between Employee and the Company dated March 5, 2020. |
4. |
Other Rights and Agreements. This Agreement does not create any employment rights not specifically set forth herein with respect to Employee. Employees employment remains at-will and can be terminated by the Company at any time and for any reason, with or without Cause. This Agreement contains the entire understanding of the Company and Employee with respect to the subject matter hereof. |
5. |
Confidentiality. Employee agrees and covenants that, except as required by applicable law, Employee shall not disclose, reveal, publish, disseminate, or discuss, directly or indirectly, to or with any other person or entity the terms of this Agreement other than his or her immediate family, lawyer and tax advisor and that any such disclosure, revelation, publication, dissemination or discussion shall result in the immediate forfeiture of the entire Retention Award. |
6. |
Taxation; Section 409A. All payments described herein shall be subject to any and all applicable federal, state, local, foreign and/or other withholding taxes and all other authorized payroll deduction. This Agreement is intended to either comply with or be exempt from the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the Code), and final regulations, rulings and other applicable guidance issued thereunder (collectively, Section 409A), and shall be interpreted and administered accordingly. For purposes of Section 409A, references to termination of employment shall, to the extent any payments hereunder are not exempt from Section 409A, be interpreted consistent with the definition of separation from service in Section 409A (after giving effect to the presumptions contained therein). If at the time of Employees termination, Employee is deemed to be a specified employee of the Company under Section 409A, then limited only to the extent necessary to comply with the requirements of Section 409A, any payments which are subject to Section 409A (and not otherwise exempt from its application) shall be withheld until the 1st business day of the 7th month following the termination of Employees employment, at which time Employee shall be paid an aggregate amount equal to the accumulated but unpaid payments otherwise due to Employee. It is intended that each installment of the payments provided in this Agreement shall be treated as a separate payment under Section 409A. Neither the Company nor Employee shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permitted or required by Section 409A. Employee may not designate the taxable year of the Retention Award. Employee acknowledges that the Company does not guarantee the tax treatment or tax consequences associated with any payment provided in this Agreement, including but not limited to under Section 409A. |
7. |
General. This Agreement may be amended only by written agreement signed by the Company and Employee. This Agreement shall be binding on the Employee and Employees executor, administrator and heirs, but may not be assigned by Employee. This Agreement may be transferred or assigned by the Company and shall be binding on the transferee or assignee. This Agreement shall automatically be transferred or assigned to and be binding upon any successor in interest to the Company, whether by merger, consolidation, sale of stock, sale of assets or otherwise. This Agreement shall be construed and enforced in accordance with the laws of Massachusetts, without giving effect to the principles of conflict of laws thereof. |
[Signature Page Follows]
2
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
Spring Bank Pharmaceuticals, Inc. | Kris Iyer | |||||
By: |
/s/ Martin Driscoll |
/s/ Kris Iyer |
||||
Name: Martin Driscoll | Signed Name | |||||
Title: President and CEO | ||||||
Kris Iyer |
||||||
Printed Name |
3
Exhibit 10.27
SPRING BANK PHARMACEUTICALS, INC.
RETENTION AND BONUS AWARD AGREEMENT
This Retention and Bonus Award Agreement (this Agreement) is made and entered into on September 9, 2020 (the Effective Date), between Spring Bank Pharmaceuticals, Inc. (the Company) and Garrett Winslow (Employee).
WHEREAS, Employee occupies a key position with the Company and in order to ensure the continued effective conduct of the Companys business, the Company desires to assure itself of the continuous services of Employee;
WHEREAS, Employee is a party to an employment agreement with the Company dated November 30, 2016 (as amended, the Employment Agreement);
WHEREAS, on July 29, 2020, the Company entered into a Share Exchange Agreement with F-star Therapeutics Limited (F-star), pursuant to which the Company will acquire all of the issued and outstanding share capital of F-star, with F-star remaining as the surviving company (the Transaction); and
WHEREAS, the Company desires to offer Employee a retention bonus award in an amount equal to $15,000 upon the closing of the Transaction (the Closing).
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the parties hereby agree as follows:
1. |
Retention Award. In the event that the Employee remains continuously employed by the Company between the Effective Date and the Closing, then Employee shall be eligible to receive a retention award in the amount of $15,000 (the Retention Award). If the Closing does not occur by March 31, 2021, this Agreement shall terminate in full without any further liability to the Company. The Retention Award shall be paid in a single lump sum on or within thirty (30) days following the Closing. |
2. |
Termination of Employment. Employee shall no longer be eligible for any portion of the Retention Award if Employees employment is terminated for any reason prior to the Closing; provided, however, that if the Company terminates Employees employment without Cause (as defined in the Employment Agreement) or Employee resigns from employment with Good Reason (as defined in the Employment Agreement) prior to the Closing, the Company shall pay Employee the Retention Award in a single lump sum on or within thirty (30) days following Employees termination of employment. |
3. |
Exclusion for Analogous Retention Benefits; No Effect on Severance and Other Benefits. An employee who is eligible for retention payments or benefits under any analogous retention plan, policy or agreement with the Company shall not be eligible for or entitled to receive this Agreement or any payment or benefit hereunder. This Agreement, however, shall not affect Employees eligibility or entitlement to receive any benefits payable (i) to Employee under another severance or change of control plan, policy or agreement with the Company or (ii) to Employee under that certain Retention Award Agreement between Employee and the Company dated March 5, 2020. |
4. |
Other Rights and Agreements. This Agreement does not create any employment rights not specifically set forth herein with respect to Employee. Employees employment remains at-will and can be terminated by the Company at any time and for any reason, with or without Cause. This Agreement contains the entire understanding of the Company and Employee with respect to the subject matter hereof. |
5. |
Confidentiality. Employee agrees and covenants that, except as required by applicable law, Employee shall not disclose, reveal, publish, disseminate, or discuss, directly or indirectly, to or with any other person or entity the terms of this Agreement other than his or her immediate family, lawyer and tax advisor and that any such disclosure, revelation, publication, dissemination or discussion shall result in the immediate forfeiture of the entire Retention Award. |
6. |
Taxation; Section 409A. All payments described herein shall be subject to any and all applicable federal, state, local, foreign and/or other withholding taxes and all other authorized payroll deduction. This Agreement is intended to either comply with or be exempt from the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the Code), and final regulations, rulings and other applicable guidance issued thereunder (collectively, Section 409A), and shall be interpreted and administered accordingly. For purposes of Section 409A, references to termination of employment shall, to the extent any payments hereunder are not exempt from Section 409A, be interpreted consistent with the definition of separation from service in Section 409A (after giving effect to the presumptions contained therein). If at the time of Employees termination, Employee is deemed to be a specified employee of the Company under Section 409A, then limited only to the extent necessary to comply with the requirements of Section 409A, any payments which are subject to Section 409A (and not otherwise exempt from its application) shall be withheld until the 1st business day of the 7th month following the termination of Employees employment, at which time Employee shall be paid an aggregate amount equal to the accumulated but unpaid payments otherwise due to Employee. It is intended that each installment of the payments provided in this Agreement shall be treated as a separate payment under Section 409A. Neither the Company nor Employee shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permitted or required by Section 409A. Employee may not designate the taxable year of the Retention Award. Employee acknowledges that the Company does not guarantee the tax treatment or tax consequences associated with any payment provided in this Agreement, including but not limited to under Section 409A. |
7. |
General. This Agreement may be amended only by written agreement signed by the Company and Employee. This Agreement shall be binding on the Employee and Employees executor, administrator and heirs, but may not be assigned by Employee. This Agreement may be transferred or assigned by the Company and shall be binding on the transferee or assignee. This Agreement shall automatically be transferred or assigned to and be binding upon any successor in interest to the Company, whether by merger, consolidation, sale of stock, sale of assets or otherwise. This Agreement shall be construed and enforced in accordance with the laws of Massachusetts, without giving effect to the principles of conflict of laws thereof. |
[Signature Page Follows]
2
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
Spring Bank Pharmaceuticals, Inc. | Garrett Winslow | |||||||
By: |
/s/ Martin Driscoll |
/s/ Garrett Winslow |
||||||
Name: Martin Driscoll | Signed Name | |||||||
Title: President and CEO | ||||||||
Garrett Winslow |
||||||||
Printed Name |
3
Exhibit 10.28
SPRING BANK PHARMACEUTICALS, INC.
RETENTION AND BONUS AWARD AGREEMENT
This Retention and Bonus Award Agreement (this Agreement) is made and entered into on September 9, 2020 (the Effective Date), between Spring Bank Pharmaceuticals, Inc. (the Company) and Lori Firmani (Employee).
WHEREAS, Employee occupies a key position with the Company and in order to ensure the continued effective conduct of the Companys business, the Company desires to assure itself of the continuous services of Employee;
WHEREAS, Employee is a party to an employment agreement with the Company dated January 1, 2020 (as amended, the Employment Agreement);
WHEREAS, on July 29, 2020, the Company entered into a Share Exchange Agreement with F-star Therapeutics Limited (F-star), pursuant to which the Company will acquire all of the issued and outstanding share capital of F-star, with F-star remaining as the surviving company (the Transaction); and
WHEREAS, the Company desires to offer Employee a retention bonus award in an amount equal to $15,000 upon the closing of the Transaction (the Closing).
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the parties hereby agree as follows:
1. |
Retention Award. In the event that the Employee remains continuously employed by the Company between the Effective Date and the Closing, then Employee shall be eligible to receive a retention award in the amount of $15,000 (the Retention Award). If the Closing does not occur by March 31, 2021, this Agreement shall terminate in full without any further liability to the Company. The Retention Award shall be paid in a single lump sum on or within thirty (30) days following the Closing. |
2. |
Termination of Employment. Employee shall no longer be eligible for any portion of the Retention Award if Employees employment is terminated for any reason prior to the Closing; provided, however, that if the Company terminates Employees employment without Cause (as defined in the Employment Agreement) or Employee resigns from employment with Good Reason (as defined in the Employment Agreement) prior to the Closing, the Company shall pay Employee the Retention Award in a single lump sum on or within thirty (30) days following Employees termination of employment. |
3. |
Exclusion for Analogous Retention Benefits; No Effect on Severance and Other Benefits. An employee who is eligible for retention payments or benefits under any analogous retention plan, policy or agreement with the Company shall not be eligible for or entitled to receive this Agreement or any payment or benefit hereunder. This Agreement, however, shall not affect Employees eligibility or entitlement to receive any benefits payable (i) to Employee under another severance or change of control plan, policy or agreement with the Company or (ii) to Employee under that certain Retention Award Agreement between Employee and the Company dated March 5, 2020. |
4. |
Other Rights and Agreements. This Agreement does not create any employment rights not specifically set forth herein with respect to Employee. Employees employment remains at-will and can be terminated by the Company at any time and for any reason, with or without Cause. This Agreement contains the entire understanding of the Company and Employee with respect to the subject matter hereof. |
5. |
Confidentiality. Employee agrees and covenants that, except as required by applicable law, Employee shall not disclose, reveal, publish, disseminate, or discuss, directly or indirectly, to or with any other person or entity the terms of this Agreement other than his or her immediate family, lawyer and tax advisor and that any such disclosure, revelation, publication, dissemination or discussion shall result in the immediate forfeiture of the entire Retention Award. |
6. |
Taxation; Section 409A. All payments described herein shall be subject to any and all applicable federal, state, local, foreign and/or other withholding taxes and all other authorized payroll deduction. This Agreement is intended to either comply with or be exempt from the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the Code), and final regulations, rulings and other applicable guidance issued thereunder (collectively, Section 409A), and shall be interpreted and administered accordingly. For purposes of Section 409A, references to termination of employment shall, to the extent any payments hereunder are not exempt from Section 409A, be interpreted consistent with the definition of separation from service in Section 409A (after giving effect to the presumptions contained therein). If at the time of Employees termination, Employee is deemed to be a specified employee of the Company under Section 409A, then limited only to the extent necessary to comply with the requirements of Section 409A, any payments which are subject to Section 409A (and not otherwise exempt from its application) shall be withheld until the 1st business day of the 7th month following the termination of Employees employment, at which time Employee shall be paid an aggregate amount equal to the accumulated but unpaid payments otherwise due to Employee. It is intended that each installment of the payments provided in this Agreement shall be treated as a separate payment under Section 409A. Neither the Company nor Employee shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permitted or required by Section 409A. Employee may not designate the taxable year of the Retention Award. Employee acknowledges that the Company does not guarantee the tax treatment or tax consequences associated with any payment provided in this Agreement, including but not limited to under Section 409A. |
7. |
General. This Agreement may be amended only by written agreement signed by the Company and Employee. This Agreement shall be binding on the Employee and Employees executor, administrator and heirs, but may not be assigned by Employee. This Agreement may be transferred or assigned by the Company and shall be binding on the transferee or assignee. This Agreement shall automatically be transferred or assigned to and be binding upon any successor in interest to the Company, whether by merger, consolidation, sale of stock, sale of assets or otherwise. This Agreement shall be construed and enforced in accordance with the laws of Massachusetts, without giving effect to the principles of conflict of laws thereof. |
[Signature Page Follows]
2
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
Spring Bank Pharmaceuticals, Inc. | Lori Firmani | |||||
By: |
/s/ Martin Driscoll |
/s/ Lori Firmani |
||||
Name: Martin Driscoll | Signed Name | |||||
Title: President and CEO | ||||||
Lori Firmani |
||||||
Printed Name |
3
Exhibit 10.29
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
LICENSE AND COLLABORATION AGREEMENT
among
F-STAR GAMMA LIMITED,
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND
ENTWICKLUNGSGES.M.B.H,
F-STAR BIOTECHNOLOGY LIMITED,
and
DENALI THERAPEUTICS INC.
Dated as of 24 August 2016
TABLE OF CONTENTS
Page | ||||
LICENSE AND COLLABORATION AGREEMENT |
1 | |||
ARTICLE 1 DEFINITIONS |
1 | |||
ARTICLE 2 COLLABORATION MANAGEMENT |
18 | |||
ARTICLE 3 TARGET NOMINATION |
21 | |||
ARTICLE 4 DEVELOPMENT AND REGULATORY |
23 | |||
ARTICLE 5 COMMERCIALIZATION |
26 | |||
ARTICLE 6 EXCLUSIVITY |
27 | |||
ARTICLE 7 OPTIONS |
29 | |||
ARTICLE 8 GRANT OF RIGHTS |
31 | |||
ARTICLE 9 PAYMENTS AND RECORDS |
35 | |||
ARTICLE 10 INTELLECTUAL PROPERTY |
42 | |||
ARTICLE 11 CONFIDENTIALITY AND NON-DISCLOSURE |
49 | |||
ARTICLE 12 REPRESENTATIONS AND WARRANTIES |
54 | |||
ARTICLE 13 INDEMNITY |
57 | |||
ARTICLE 14 TERM AND TERMINATION |
60 | |||
ARTICLE 15 MISCELLANEOUS |
67 |
Confidential
-i-
THIS LICENSE AND COLLABORATION AGREEMENT is made and entered into effective as of 24 August 2016 (the Effective Date) by and between
(1) |
F-STAR GAMMA LIMITED, a limited liability company incorporated under the laws of England and Wales (Licensor), and |
(2) |
DENALI THERAPEUTICS INC., a corporation organized under the laws of Delaware (Denali); and |
(3) |
F-STAR BIOTECHNOLOGY LIMITED, a limited liability company incorporated under the laws of England and Wales (F-star Ltd) solely for the purposes of the Sections referenced on the signature page hereto, and F-STAR BIOTECHNOLOGISCHE FORSCHUNGS- UND ENTWICKLUNGSGES.M.B.H, an Austrian limited liability company incorporated under the laws of the Republic of Austria (F-star GmbH) solely for the purposes of the Sections referenced on the signature page hereto. |
Licensor and Denali are sometimes referred to herein individually as a Party and collectively as the Parties.
BACKGROUND
(A) |
Licensor Controls (as defined herein) certain intellectual property rights with respect to Fcabs (as defined herein), mAb2 (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein). |
(B) |
Denali has expertise with respect to blood-brain barrier transcytosis. In order to facilitate the development of products the Parties have agreed to collaborate in the identification of Fcabs that have utility in the delivery of therapeutics across the blood-brain barrier which Denali shall use to develop Licensed Products. |
(C) |
Licensor wishes to grant to Denali, and Denali wishes to take, on an Accepted Fab Target (as defined herein) by Accepted Fab Target basis, an option to a license under such intellectual property rights to develop and commercialize Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below. |
(C) |
Under separate agreements, including the Buy-out Option Agreement (as defined herein) the shareholders in Licensor have granted an option to Denali to acquire the entire share capital in Licensor pursuant to the terms of the SPA (as defined herein). |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement and the Schedules to this Agreement the following capitalized terms, whether used in the singular or plural, shall have the meanings set out below:
1.1 |
Accepted Fcab Target means an Fcab Target that has become an Accepted Fcab Target as provided for in Section 3.1.6. |
Confidential
- 1 -
1.2 |
Accepted Fab Target means a Fab Target that has become an Accepted Fab Target as provided for in Section 3.4. With respect to a Fab that is an Incorporated Biologic, the Accepted Fab Target will mean the Incorporated Biologic itself. |
1.3 |
Accounting Standards means, with respect to (a) Licensor, F-star Ltd or F-star GmbH, that records and books of accounts shall be maintained in accordance with International Financial Reporting Standards (IRFS), and (b) Denali or its Affiliates or Sublicensees, that records and books of accounts shall be maintained in accordance with United States Generally Accepted Accounting Principles or IFRS. |
1.4 |
Affiliate means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, control and, with correlative meanings, the terms controlling, controlled by and under common control with means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity. Notwithstanding the foregoing: (i) none of [***] shall be deemed an Affiliate of Licensor or of each other, other than [***], which are Affiliates solely of each other; and (ii) no company with substantially the same shareholders as Licensor or [***] shall be an Affiliate of any of the Licensor, [***]. |
1.5 |
Agreement means this agreement and all schedules, appendices and other addenda attached hereto as any of the foregoing may be amended in accordance with the provisions of this Agreement. |
1.6 |
Alliance Manager has the meaning set forth in Section 2.10. |
1.7 |
Antibody means an immunoglobulin (Ig) molecule or fragment thereof that binds to an antigen and shall include monospecific and multispecific immunoglobulin molecules or a nucleic acid-containing molecule that encodes such an immunoglobulin molecule or fragment thereof including any of the foregoing as conjugates bound to a toxin, label or other moiety. In the case of an Incorporated Biologic, Antibody will mean the Ig molecule or fragment thereof together with the attached Incorporated Biologic. |
1.8 |
Applicable Law means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder. |
1.9 |
Approved Subcontractors means those subcontractors specified in each Fcab Discovery Plan and each mAb2 Development Plan or otherwise agreed to by the Parties in writing. For clarity, F-star Ltd will be an Approved Subcontractor for Licensor. |
1.10 |
Audit Arbitrator has the meaning set forth in Section 9.18. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
- 2 -
1.11 |
Bankruptcy Code has the meaning set forth in Section 14.8.1. |
1.12 |
Biosimilar Application has the meaning set forth in Section 10.3.3. |
1.13 |
BLA has the meaning set forth in the definition of Drug Approval Application in Section 1.43. |
1.14 |
Breaching Party has the meaning set forth in Section 14.4. |
1.15 |
Business Day means a day other than a Saturday or Sunday on which banking institutions in San Francisco, California or London, England are open for business. |
1.16 |
Buy-out Option Agreement means the agreement made between Denali and the shareholders of Licensor dated on the Effective Date, a copy of which is included as Schedule 1.16. |
1.17 |
Buy-out Option Period means the period commencing on the Effective Date and ending on the earlier of (i) Denalis Initiation of the first Clinical Study of a mAb2; and (ii) the fourth (4th) anniversary of the first Fcab Delivery as extended pursuant to Section 7.1 or (iii) the sixty sixth (66th) month after delivery by Denali of a Denali Fcab Notice as extended pursuant to Section 7.1. |
1.18 |
Buy-out Option means the option to buy the entire share capital of Licensor pursuant to the Buy-out Option Agreement. |
1.19 |
Calendar Quarter means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. |
1.20 |
Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. |
1.21 |
Centralized Approval Procedure means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. |
1.22 |
Clinical Studies means Phase I, Phase II, Phase III, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise conducted or recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the approved indications for such Licensed Product. |
1.23 |
Combination Product means a Licensed Product containing or consisting of one (1) or more mAb2 and one (1) or more Other Active Ingredients, whether in the same or different formulations. |
1.24 |
Commercialization means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a molecule or product, including activities related to marketing, promoting, distributing, importing and exporting such molecule or product, and, for purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting medical affairs activities and conducting Phase IV Studies, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, to Commercialize and Commercializing means to engage in Commercialization, and Commercialized has a corresponding meaning. |
Confidential
- 3 -
1.25 |
Commercially Reasonable Efforts means, with respect to the performance of Development, Commercialization, or Manufacturing activities with respect to an Fcab, a mAb2 or a Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources that such Party would typically devote to compounds or products of similar market potential at a similar stage in development or product life. |
1.26 |
Confidential Information means any Information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement after the Effective Date, including Information relating to the terms of this Agreement, any Fcab, any mAb2 or any Licensed Product, any Exploitation of any Fcab or any mAb2 or any Licensed Product, any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates (including Denali Program Know-How and Licensor Program Know-How, as applicable), or the scientific, regulatory or business affairs or other activities of either Party. For the avoidance of doubt, any disclosure of Confidential Information by F-star Ltd or F-star GmbH to Denali or its Affiliates shall be deemed to be a disclosure on behalf of Licensor. Notwithstanding the foregoing, (a) Licensor Background IP and Licensor Program IP will be considered Confidential Information of Licensor, (b) Denali Background IP and Denali Program IP will be considered Confidential Information of Denali, and (c) Joint Program IP shall be deemed to be the Confidential Information of both Parties, and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto. |
1.27 |
Control means, with respect to any item of Information, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of the license and other grants in ARTICLE 8), to grant a license, sublicense or other right to or under such Information, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party; provided, that, except in the case of the Gamma IP License, neither Party shall be deemed to Control any item of Information, material, Patent, or other property right of a Third Party if access under this Agreement requires or triggers a payment obligation, unless the Party being granted a sublicense hereunder to such Information, material, Patent or other property right agrees in writing to pay such payment obligation. |
1.28 |
CREATE Act has the meaning set forth in Section 10.2.4. |
1.29 |
Default Notice has the meaning set forth in Section 14.4. |
1.30 |
Denali Background IP means, collectively, Denali Background Patents and Denali Background Know-How. |
1.31 |
Denali Background Know-How means, to the extent such Know-How is disclosed by Denali to Licensor, any and all Know-How Controlled by Denali on the Effective Date or during the Term that is developed or invented as a result of performing activities outside the scope of each Fcab Discovery Plan and each mAb2 Development Plan and that is necessary or useful for the research, discovery or Exploitation of any Fcab against any Accepted Fcab Target, or an Antibody containing such Fcab, or any |
Confidential
- 4 -
mAb2. Denali Background Know-How specifically includes any Antibody (other than any Fcabs and/or mAb2s) that is Controlled by Denali or its Affiliates which are necessary or useful for the purpose of performing activities under, or otherwise utilized in, an Fcab Discovery Plan or a mAb2 Development Plan. |
1.32 |
Denali Background Patents means any and all Patents Controlled by Denali on the Effective Date or during the Term that are invented as a result of performing activities outside the scope of each Fcab Discovery Plan and each mAb2 Development Plan and that in the absence of a License would be infringed by the research, discovery or Exploitation of any Fcab against any Accepted Fcab Target, or an Antibody containing such Fcab, or any mAb2. Denali Background Patents specifically includes the claims of any Patent that covers an Antibody (other than any Fcabs and/or mAb2s) that is Controlled by Denali or its Affiliates for the purpose of performing activities under, or otherwise utilized in, an Fcab Discovery Plan or mAb2 Development Plan. |
1.33 |
Denali Fcab means an Fcab which binds to an Accepted Fcab Target that was first identified from a Denali Library, and which Fcab is not a Joint Fcab, and for which Denali informs Licensor in writing that Denali is progressing with such Fcab (such notice the Denali Fcab Notice). |
1.34 |
Denali Indemnitees has the meaning set forth in Section 13.2. |
1.35 |
Denali Library means any repertoire of Antibodies which have binding sites in a constant domain and which repertoire is generated by Denali whilst carrying out Technical Development. |
1.36 |
Denali Program IP means, collectively, Denali Program Patents and Denali Program Know-How. |
1.37 |
Denali Program Know-How means any and all Know-How that is not Platform Know-How and that is developed or invented after the Effective Date (a) solely by or on behalf of Denali or its Affiliates or agents in performing activities under each Fcab Discovery Plan (including Know-How relating to any Denali Fcab or Joint Fcab but excluding any Licensor Program Know-How or Licensor Program Patents) or (b) by or on behalf of Denali or its Affiliates or Licensor (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise) or its Affiliates or jointly by Denali or its Affiliates and Licensor or its Affiliates in performing activities under each mAb2 Development Plan (including any mAb2 as a composition of matter). Denali Program Know-How specifically excludes Denali Background Know-How, Licensor Program Know-How and Joint Program Know-How. |
1.38 |
Denali Program Patents means any and all Patents that are not Platform Patents and that claim inventions invented after the Effective Date (a) solely by or on behalf of Denali or its Affiliates or agents in performing activities under each Fcab Discovery Plan (including relating to any Denali Fcab or Joint Fcab but excluding any Licensor Program Know-How or Licensor Program Patents) or (b) by or on behalf of Denali or its Affiliates in performing activities under each mAb2 Development Plan (including any mAb2 as a composition of matter, use, formulation or manufacture); or (c) by or on behalf of Licensor (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise) or its Affiliates or jointly by Denali or its Affiliates and Licensor or its Affiliates in performing activities under each mAb2 Development Plan (including any mAb2 as a composition of matter). Denali Program Patents specifically exclude Denali Background Patents, Licensor Program Patents and Joint Program Patents. |
1.39 |
Development means all activities related to pre-clinical and other non-clinical discovery, research, testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and |
Confidential
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submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, Develop means to engage in Development. For purposes of clarity, Development shall include any submissions and activities required in support thereof, required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved molecule or product. |
1.40 |
Dispute has the meaning set forth in Section 15.7. |
1.41 |
Distributor has the meaning set forth in Section 8.7. |
1.42 |
Dollars or $ means United States Dollars. |
1.43 |
Drug Approval Application means a Biologics License Application (a BLA) as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (a MAA) filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure. |
1.44 |
Effective Date means the effective date of this Agreement as set forth in the preamble hereto. |
1.45 |
EMA means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.46 |
European Union or E.U. means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto. |
1.47 |
Exploit or Exploitation means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of. |
1.48 |
Fab means the region on an Antibody that (a) binds to an antigen and is either composed of (i) one (1) constant and one (1) variable domain of each of the heavy and the light chain wherein the binding sites are located in the variable domains, or (ii) is another protein or polypeptide that specifically binds to an antigen or substrate, or (b) constitutes a [***] or, subject to agreement (or resolution) as set out in Section 3.3, a [***] (an Incorporated Biologic). |
1.49 |
Fcab means a constant domain of an Antibody that includes an antigen binding site that confers a specific binding of such constant domain to a defined target antigen. |
1.50 |
Fcab Delivery has the meaning set forth in Section 4.3. |
1.51 |
Fcab Delivery Criteria means the criteria for Fcab Delivery for each Accepted Fcab Target as agreed pursuant to Section 2.2.4. The Fcab Delivery Criteria for the TfR Accepted Fcab Target are appended as set out in Schedule 1.51. |
1.52 |
Fcab Disclosure Period has the meaning set forth in Section 9.11. |
1.53 |
Fcab Discovery Plan means the plan and criteria setting forth the research and development activities of the Parties prior to Fcab Delivery, as the same may be amended from time to time in accordance with the terms hereof. The TfR Fcab Discovery Plan is attached hereto as Schedule 1.51. |
1.54 |
Fcab Validation Period means that period set out in the relevant Fcab Discovery Plan during which Denali should have used Commercially Reasonable Efforts to have conducted the validation experiment(s) set out in the Fcab Discovery Plan in respect of the relevant Fcab delivered by Licensor pursuant to the relevant Fcab Discovery Plan. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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1.55 |
FDA means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.56 |
FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.57 |
Field means any use. |
1.58 |
First Commercial Sale means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after Regulatory Approval for such Licensed Product has been obtained in such country. Sales prior to receipt of Regulatory Approval for such Licensed Product, such as so-called treatment IND sales, named patient sales, and compassionate use sales, shall not be construed as a First Commercial Sale. |
1.59 |
F-star Alpha means F-star Alpha Limited, a limited liability company incorporated under the laws of England and Wales with registered number 08676690. |
1.60 |
F-star Beta means F-star Beta Limited, a limited liability company incorporated under the laws of England and Wales with registered number 09263520. |
1.61 |
FTE Rate means, for the period from the Effective Date to 31 December 2017, [***] US dollars (US$[***]). Thereafter, the FTE Rate shall be increased or decreased on 1 January of each year by the annual percentage increase or decrease in the UK Consumer Price Inflation published by the UK Office of National Statistics. |
1.62 |
FTE means the equivalent of the work of one appropriately qualified individual working on a full-time basis in performing work in connection with this Agreement for a twelve (12) month period (consisting of at least a total of [***] hours per year of dedicated effort). FTE efforts shall not include the work of general corporate or administrative personnel. |
1.63 |
Gamma IP License means that certain Amended and Restated Gamma IP License, between Licensor and F-star Ltd, dated as of the Effective Date, as may be amended or restated from time to time. |
1.64 |
Gamma Support Services Agreement means that certain Gamma Support Services Agreement, between Licensor and F-star Ltd, dated as of the Effective Date, as may be amended or restated from time to time. |
1.65 |
Gatekeeper Notice has the meaning set forth in Section 3.3. |
1.66 |
Gatekeeper means an independent Third Party appointed by F-star Ltd promptly following the Effective Date for the purpose of confirming proposed Accepted Fab Targets and proposed Accepted Fcab Targets on mutually agreeable terms including provisions relating to confidentiality. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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1.67 |
Good Manufacturing Practice or GMP means the current good manufacturing practices applicable from time to time to the Manufacturing of a mAb2 or Licensed Product or any intermediate thereof pursuant to Applicable Law. |
1.68 |
HSR Act has the meaning set forth in Section 15.2.1. |
1.69 |
Incorporated Biologic has the meaning set forth in Section 1.48. |
1.70 |
IND means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., Clinical Trial Application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing. |
1.71 |
Indemnification Claim Notice has the meaning set forth in Section 13.3. |
1.72 |
Indemnified Party has the meaning set forth in Section 13.3. |
1.73 |
Indication means a specific disease, disorder or condition which is recognized by the applicable Regulatory Authority in a given country or jurisdiction as a disease, disorder or condition, and all its associated signs, symptoms and stages of prognosis. For the avoidance of doubt, all variants of a single disease, disorder or condition (whether classified by severity or otherwise), and subpopulations of patients with the primary disease, disorder or condition, will be treated as the same Indication. |
1.74 |
Indirect Taxes has the meaning set forth in Section 9.15. |
1.75 |
Information means all information of a technical, scientific, business and other nature, including Know-How, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed. |
1.76 |
Initiation or Initiate means, with respect to a Clinical Study, the first dosing of the fifth human subject in such Clinical Study. |
1.77 |
Intellectual Property has the meaning set forth in Section 14.8.1. |
1.78 |
Joint Fcab means an Fcab which binds to an Accepted Fcab Target that was first identified from a Denali Library in respect of which Licensor, F-star Ltd, F-star GmbH or their Affiliates have made an inventive contribution to such Fcab, such that under U.S. patent law at least one employee, consultant or agent of Licensor, F-star Ltd, F-star GmbH or their Affiliates would be named as an inventor on a patent filing which claims the composition of matter of such Fcab. If there is a Dispute regarding whether an employee of Licensor, F-star Ltd, F-star GmbH or their Affiliates should be named as an inventor on a patent filing which claims such Fcab, then the Parties would follow the resolution procedures under Section 15.7 to resolve the Dispute, provided that the selected arbitrators shall have knowledge and experience in determining inventorship under U.S. patent law. |
1.79 |
Joint Program IP means, collectively, Joint Program Patents and Joint Program Know-How. |
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1.80 |
Joint Program Know-How means any and all Know-How that is not Platform Know-How and that is developed or invented after the Effective Date jointly by or on behalf of Denali on the one hand, and by or on behalf of Licensor on the other hand (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise), in performing activities under each Fcab Discovery Plan (but excluding any Licensor Program Know-How, Licensor Program Patents, Denali Program Know-How or Denali Program Patents). Joint Program Know-How specifically excludes Denali Background Know-How, Denali Program Know-How, Licensor Background Know-How and Licensor Program Know-How. |
1.81 |
Joint Program Patents means any and all Patents that are not Platform Patents and that claim inventions invented after the Effective Date jointly by or on behalf of Denali on the one hand, and by or on behalf of Licensor on the other hand (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise), in performing activities under each Fcab Discovery Plan but excluding any Licensor Program Know-How, Licensor Program Patents, Denali Program Know-How or Denali Program Patents. |
1.82 |
Joint Steering Committee or JSC has the meaning set forth in Section 2.1. |
1.83 |
Know-How means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions. |
1.84 |
License Option Term means, in respect of an Accepted Fab Target, the period starting on the date that the relevant Accepted Fab Target became an Accepted Fab Target and ending on the earlier of (i) the [***]; (ii) the exercise of the License Option in respect of that Accepted Fab Target; and (iii) upon the earlier written notice by Denali of its decision to terminate the License Option Term in respect of such Accepted Fab Target pursuant to Section 14.5. |
1.85 |
License Option has the meaning set forth in Section 7.2. |
1.86 |
Licensed Product means, on a mAb2-by-mAb2 basis, any product for use in the Field in the Territory that contains that mAb2, alone or in combination with one (1) or more Other Active Ingredients. Licensed Products in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes, including any improvements thereto shall be deemed to be the same Licensed Product. |
1.87 |
Licensor Background IP means, collectively, Licensor Background Patents and Licensor Background Know-How. |
1.88 |
Licensor Background Know-How means, to the extent that such Know-How is disclosed to Denali by Licensor, any and all Know-How Controlled by Licensor on the Effective Date or during the Term that is developed or invented as a result of performing activities outside the scope of each Fcab Discovery Plan and each mAb2 Development Plan and that is necessary or useful for the research, discovery or Exploitation of any mAb2. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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1.89 |
Licensor Background Patents means any and all Patents Controlled by Licensor on the Effective Date or during the Term that are invented as a result of performing activities outside the scope of each Fcab Discovery Plan and each mAb2 Development Plan and that in the absence of a license would be infringed by the research, discovery or Exploitation of any mAb2, including, but not limited to, the patents and patent applications set forth on Schedule 1.89. |
1.90 |
Licensor Fcab means an Fcab which binds to an Accepted Fcab Target that was first identified by the Licensor other than from a Denali Library. |
1.91 |
Licensor Indemnitees has the meaning set forth in Section 13.1. |
1.92 |
Licensor In-Licenses means all agreements (as modified, amended or restated as of the Effective Date), pursuant to which Licensor or its Affiliates derive any right, title or interest in or to the Licensor Background IP, including without limitation the Gamma IP License. |
1.93 |
Licensor Program IP means, collectively, Licensor Program Patents and Licensor Program Know-How. |
1.94 |
Licensor Program Know-How means any and all Know-How that is developed or invented after the Effective Date (a) solely by or on behalf of Licensor (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise) in performing activities under each Fcab Discovery Plan or (b) by or on behalf of Denali or its Affiliates or Licensor (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise) or its Affiliates or jointly by Denali or its Affiliates and Licensor or its Affiliates in each case in connection with activities under each Fcab Discovery Plan and/or a mAb2 Development Plan and/or Technical Development, and to the extent it relates to an Fcab (other than a Denali Fcab or Joint Fcab), other than as part of a mAb2. Licensor Program Know-How specifically excludes Licensor Background Know-How, Platform Know-How, Denali Program Know-How and Joint Program Know-How. |
1.95 |
Licensor Program Patents means any and all Patents claiming inventions invented after the Effective Date (a) solely by or on behalf of Licensor (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise) and its Affiliates in performing activities under each Fcab Discovery Plan or (b) by or on behalf of Denali or its Affiliates or Licensor (including any of Licensors Approved Subcontractors, and under the Gamma Support Services Agreement or otherwise) or its Affiliates or jointly by Denali or its Affiliates and Licensor or its Affiliates in each case in connection with activities under each Fcab Discovery Plan and/or a mAb2 Development Plan and/or Technical Development, and to the extent claiming or covering an Fcab (other than a Denali Fcab or Joint Fcab), other than as part of a mAb2. Licensor Program Patents specifically exclude Licensor Background Patents, Platform Patents, Denali Program Patents and Joint Program Patents. |
1.96 |
Losses has the meaning set forth in Section 13.1. |
1.97 |
MAA has the meaning set forth in the definition of Drug Approval Application in Section 1.43. |
1.98 |
mAb2 Development Plan means, on a mAb2-by-mAb2 basis, the written research plan prepared by Denali in accordance with Section 3.4 for the applicable mAb2 or Licensed Product, and to be performed by or on behalf of Denali during the Research Term, as the same may be amended from time to time in accordance with the terms hereof. |
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1.99 |
mAb2 means an Antibody (a) which contains a Denali Fcab, Joint Fcab or Licensor Fcab (or an Fcab that Denali modified or optimized from any of the foregoing) and (b) which contains a Fab that specifically binds to an Accepted Fab Target (or in the case of an Accepted Fab Target that is an Incorporated Biologic, which contains that Accepted Fab Target). |
1.100 |
mAb2 License shall have the meaning set out in Section 7.2. |
1.101 |
Major Market means each of [***]. |
1.102 |
Manufacture and Manufacturing means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any molecule, product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterization, supply chain, stability testing, quality assurance testing and release, and quality control. |
1.103 |
Mono Product has the meaning set forth in the definition of Net Sales in Section 1.104. |
1.104 |
Net Sales means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by Denali, its Affiliates, or Sublicensees in the Territory to Third Parties (such Third Parties including wholesalers or Distributors), in bona fide arms length transactions, less the following deductions, in each case related specifically to the Licensed Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to Denali, its Affiliates, or Sublicensees: |
(a) |
trade, cash and quantity discounts; |
(b) |
price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
(c) |
taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; |
(d) |
amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; |
(e) |
the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or similar entities or Medicare Prescription Drug Plans relating to such Licensed Product; |
(f) |
freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains and other service providers related to inventory management or the distribution of such Licensed Product; and |
(g) |
uncollectable debt up to a maximum of [***] of Net Sales. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by Denali, its Affiliates or Sublicensees in respect of the sale of Licensed Product, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between or among Denali, its Affiliates, or Sublicensees.
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of Denali, its Affiliates, or Sublicensees, which must be in accordance with Accounting Standards.
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 9.13.
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows:
(i) |
If Denali, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient a mAb2 contained in such Combination Product (the Mono Product) and (B) products containing as their sole active ingredients the Other Active Ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: A is Denalis (or its Affiliates or Sublicensees, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and B is Denalis (or its Affiliates or Sublicensees, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the Other Active Ingredients in such Combination Product. |
(ii) |
If Denali, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the Other Active Ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: A is Denalis (or its Affiliates or Sublicensees, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and C is Denalis (or its Affiliates or Sublicensees, as applicable) average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product. |
(iii) |
If Denali, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the Other Active Ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: D is the average Net Sales price during the period to which the Net Sales calculation applies for such Combination Product in such country or other jurisdiction and E is the average Net Sales price during the period to which the Net Sales calculation applies for products that contain as their sole active ingredients the Other Active Ingredients in such Combination Product. |
(iv) |
If Denali, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the Other Active Ingredients or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such Other Active Ingredient or ingredients. If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 15.7. |
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1.105 |
Non-Breaching Party has the meaning set forth in Section 14.4. |
1.106 |
Other Active Ingredient means any component that provides pharmacological activity or other direct therapeutic effect in the Field or that therapeutically affects the structure or any function of the body whereby such component is not covered by a Valid Claim of the Licensor Background Patents, Licensor Program Patents or the Joint Program Patents. |
1.107 |
Patent Challenge has the meaning set forth in Section 14.6. |
1.108 |
Patents means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, and (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b), and (c)). |
1.109 |
Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. |
1.110 |
Phase I means a human clinical trial of a Licensed Product, the principal purpose of which is a preliminary determination of safety, tolerability, dosing, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, including the trials referred to in 21 C.F.R. §312.21(a), as amended. |
1.111 |
Phase II means a human clinical trial of a Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended. |
1.112 |
Phase III means a human clinical trial of a Licensed Product on a sufficient number of subjects in an indicated patient population that is prospectively designed to establish that a mAb2 or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such mAb2 or Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended. |
1.113 |
Phase IV Study means a post-marketing human clinical study for a Licensed Product with respect to any indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program. |
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1.114 |
PHSA means the United States Public Health Service Act, as amended from time to time. |
1.115 |
Platform IP means Platform Know-How and Platform Patents. |
1.116 |
Platform Know-How means Know-How which was first generated by either Party under an Fcab Discovery Program and/or a mAb2 Development Plan and/or Technical Development (whenever it was undertaken) which constitutes (i) improvements, modifications and enhancements to the inventions claimed (either in issued claims or pending claims) in the Licensor Background Patents that exist as of the Effective Date, and such improvements, modifications and enhancements are covered by claims (either in issued claims or pending claims) of the Licensor Background Patents that exist as of the Effective Date (ii) [***] (iii) [***] and (iv) [***] provided always that Platform Know-How does not include any Know-How which constitutes (a) the amino acid sequence of the antigen binding site and Fcab constant domain wherein such antigen binding site sequence confers specific binding of the Fcab to an Accepted Fcab Target or (b) the use of an Antibody and its sequence which has an antigen binding site in a constant domain wherein such sequence confers specific binding of the constant domain to an Accepted Fcab Target or (c) the manufacture or formulation (or methods of manufacture or formulation) of an Antibody and its sequence which has a binding site in a constant domain wherein such sequence confers specific binding to an Accepted Fcab Target or (d) the modification of a native binding site within binding loops to a native antigen [***]. |
1.117 |
Platform Patents means any Patent claiming or covering any invention which was first conceived by either Party under an Fcab Discovery Program and/or a mAb2 Development Plan and/or Technical Development (whenever it was undertaken) which claims or covers (i) improvements, modifications and enhancements to the inventions claimed (either in issued claims or pending claims) in the Licensor Background Patents that exist as of the Effective Date, and such improvements, modifications and enhancements are covered by the claims (either in issued claims or pending claims) of the Licensor Background Patents that exist as of the Effective Date (ii) [***] (iii) [***] and (iv) [***] provided always that Platform Patents do not include any Patent which specifically claims or covers (a) the amino acid sequence of the antigen binding site and Fcab constant domain wherein such antigen binding site sequence confers specific binding of the Fcab to an Accepted Fcab Target or (b) the use of an Antibody and its sequence which has a binding site in a constant domain wherein such sequence confers specific binding of the constant domain to an Accepted Fcab Target or (c) the manufacture or formulation (or methods of manufacture or formulation) of an Antibody and its sequence which has a binding site in a constant domain wherein such sequence confers specific binding of the constant domain to an Accepted Fcab Target or (d) the modification of a native binding site within binding loops to a native antigen, [***]. |
1.118 |
PMDA means Japans Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function. |
1.119 |
Product Trademarks means the trademark(s) to be used by Denali or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties, F-star Ltd, F-star GmbH or their Affiliates). |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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1.120 |
Proposed Fcab has the meaning set forth in Section 4.3. |
1.121 |
Publishing Party has the meaning set forth in Section 11.5.4. |
1.122 |
Regulatory Approval means, with respect to a country or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a mAb2 or Licensed Product in such country or other jurisdiction, including, where applicable, (a) pricing or reimbursement approval in such country or other jurisdiction, and (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto). |
1.123 |
Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of any mAb2 or Licensed Products in the Territory. |
1.124 |
Regulatory Exclusivity means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which Denali or its Affiliates, Distributors or Sublicensees have the exclusive right to market and sell a mAb2 or Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity) provided always that in the case of Regulatory Exclusivity based on orphan drug exclusivity in a country such Regulatory Exclusivity shall be deemed to expire in such country if a Third Party is selling a product in such country that is clinically superior to the applicable Licensed Product, applying the definition of clinically superior set forth in 21 C.F.R. § 316.3(b)(3) (or, with respect to any country other than the United States, the definition that is applied to permit such Third Party to sell such product notwithstanding the orphan drug exclusivity (including that the Third Party product is considered to be safer, more effective or otherwise clinically superior as provided for in Regulation EC 141/2000)). |
1.125 |
Research Term means, on a mAb2by-mAb2 basis, the period beginning on the Effective Date and ending upon the filing of an IND by Denali on the mAb2. |
1.126 |
Royalty Term means, with respect to each Licensed Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country, and ending on the later to occur of (a) the expiration, invalidation or abandonment date of the last Licensor Background Patent, Licensor Program Patent, a Denali Program Patent or Joint Program Patent that includes a Valid Claim that claims or covers the manufacture, sale, or use (provided such use is the subject of a Regulatory Approval obtained by or on behalf or Denali, its Affiliates or Sublicensees or Distributors of the mAb2 or Licensed Product of such Licensed Product in such country) of such Licensed Product in such country, (b) the expiration of Regulatory Exclusivity for such Licensed Product in such country; and (c) the twelfth (12th) anniversary of the First Commercial Sale of such Licensed Product in such country. |
1.127 |
Selected Fcab Program Patent has the meaning set forth in Section 10.2.1. |
1.128 |
Selected Fcab means an Fcab directed to an Accepted Fcab Target. |
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1.129 |
Senior Officer means, with respect to Licensor, its Chief Executive Officer or his/her designee, and with respect to Denali, its Chief Executive Officer or his/her designee. |
1.130 |
Sublicensee means a Third Party, other than a Distributor, that is granted a sublicense by Denali under the grants in Section 8.1 as provided in Section 8.6. |
1.131 |
Target means the target specifically bound by the Fcab or the Fab in an Antibody. With respect to an Incorporated Biologic, the Target will mean the Incorporated Biologic itself and not the target(s) bound by the Incorporated Biologic. For purposes of exclusivity or grant of licenses (i.e. Denalis right to include a variant of a target), Target will also include fragments or polymorphisms (including without limitation splice variants or mutants) of such target antigen (or Incorporated Biologic) provided that in each case Entrez Gene ID, HUGO, UniProt, SwissProt or other gene/protein listing database used on the date the Target is gatekept specifically identifies that such fragment or polymorphism is related to such Target or Incorporated Biologic by identifying it as a fragment and/or polymorphism of such Target or Incorporated Biologic in the database record. By way of example, and without limitation, if there is an Accepted Fab Target that is an antigen commonly known as CDXXX, and subsequently a polymorphism of CDXXX is submitted to one of the gene/protein listing databases, and where the listing specifically identifies the new listing as a polymorphism of CDXXX, then provided such polymorphism is not at such time an Unavailable Fab Target, such polymorphism would also be considered the Accepted Fab Target under this Agreement (and subject to the exclusivity and grant of licenses). |
1.132 |
Technical Development Term means the term for the license granted by Licensor to Denali under Section 8.1.1, which term commenced prior to the Effective Date and continues, with respect to an Accepted Fcab Target-by-Accepted Fcab Target, until [***] after the date that Denali determines to cease funding Licensors costs under the Fcab Discovery Plan for such Accepted Fcab Target pursuant to Section 9.2 (provided such determination date is not less than [***] after Denali has transferred to F-star all reagents and assays for F-star to conduct the antigen validation (e.g. conclusion of Step 1, Antigens of Schedule 1.51 for the TfR Fcab Discovery Plan) for the Accepted Fcab Target pursuant to the applicable Fcab Discovery Plan). |
1.133 |
Technical Development means the use by Denali of the Licensor Background IP existing at the Effective Date, to Develop Fcabs and to generate libraries of Fcabs and/or to undertake further development of the Licensor Background IP in each case to support the development of Fcabs. |
1.134 |
Term means the period commencing on the Effective Date and expiring on the expiry of the term of this Agreement as set forth in Section 14.1 or the earlier termination in accordance with the terms of this Agreement in relation to all Denalis Accepted Fcab Targets or Accepted Fab Targets. |
1.135 |
Territory means all countries and territories worldwide. |
1.136 |
Third Party Claims has the meaning set forth in Section 13.1. |
1.137 |
Third Party means any Person other than Licensor, F-star GmbH, F-star Ltd, Denali and their respective Affiliates. For clarity both of F-star Alpha or F-star Beta shall be deemed Third Parties. |
Confidential
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1.138 |
TfR means Transferrin Receptor also known as TFR1, TRFR and TFR which is identified by UniProt number P02786. |
1.139 |
Unavailable Targets means the Unavailable Fcab Targets and the Unavailable Fab Targets. |
1.140 |
Unavailable Fab Targets has the meaning set forth in Section 3.3. |
1.141 |
Unavailable Fcab Targets has the meaning set forth in Section 3.3. |
1.142 |
Valid Claim means either: (a) a claim of a pending Patent application, which claim was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application and such application has not been outstanding for more than [***] from its earliest priority date; or (b) a claim of any issued and unexpired Patent directed to patentable subject matter for which the validity, enforceability, or patentability has not been affected by any of the following: (x) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (y) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal. |
1.143 |
Working Group has the meaning set forth in Section 2.12. |
1.144 |
In this Agreement: |
1.144.1 |
all references to a particular clause, section or schedule shall be a reference to that clause, section or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement; |
1.144.2 |
the headings are inserted for convenience only and shall be ignored in construing this Agreement; |
1.144.3 |
words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa; |
1.144.4 |
words denoting persons shall include any individual, partnership, company, corporation, joint venture, trust association, organisation or other entity, in each case whether or not having separate legal personality; |
1.144.5 |
the Parties acknowledge that certain of the responsibilities of Licensor shall be undertaken by F-star Ltd and/or F-star GmbH under the Gamma Support Services Agreement and they further acknowledge that any references to by or on behalf of Licensor or similar expressions shall include activities undertaken by F-star Ltd and/or F-star GmbH. |
1.144.6 |
the words include, included and including are to be construed without conveying any limitation to the generality of the preceding words; |
1.144.7 |
reference to any statute or regulation includes any modification or re-enactment of that statute or regulation; |
1.144.8 |
any reference to notices or consent being sought or given in writing shall require the consent or notice to be signed by an appropriately authorised person and shall not include consents or notices conveyed by email; and |
1.144.9 |
in the event of any inconsistency or conflict between this Agreement and any of the Schedules, this Agreement shall prevail. |
Confidential
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ARTICLE 2
COLLABORATION MANAGEMENT
2.1 |
Joint Steering Committee. Within fifteen (15) days after the Effective Date, or as mutually agreed to by the Parties, the Parties shall establish a joint steering committee (the Joint Steering Committee or JSC). The JSC shall consist of two (2) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JSC. From time to time, each Party may substitute one (1) or more of its representatives to the JSC subject to providing prior written confirmation (which may be by email) to the other Party. The chairman of the JSC shall alternate on an annual basis between a representative selected by Licensor and a representative selected by Denali, with the first JSC chairman selected by Licensor. From time to time, Denali or Licensor may change the representative who will serve as chairperson on written notice to the other Party. |
2.2 |
Specific Responsibilities of the JSC. On an Fcab-by-Fcab and a mAb2-by-mAb2 basis, until the expiration of the License Option Term for such Accepted Fab Target, the JSC shall review the strategy for the Development of mAb2s. In particular, at each meeting the JSC shall: |
2.2.1 |
discuss Denalis Technical Development. |
2.2.2 |
discuss the suitability of an Fcab Target for the generation of Fcabs and mAb2 pursuant to Section 3.1.5. |
2.2.3 |
agree on the Fcab Discovery Plan for each Accepted Fcab Target, based on the Fcab Discovery Plan for the TfR Accepted Fcab Target which is appended as Schedule 1.51; |
2.2.4 |
agree on (i) the Fcab Delivery Criteria for each Accepted Fcab Target, based on the Fcab Delivery Criteria for the TfR Accepted Fcab Target which are set out in Schedule 1.51; and (ii) the protocol for the validation experiment(s) required for the Fcab Delivery Criteria. |
2.2.5 |
review and discuss the conduct of research and Development activities under each Fcab Discovery Plan, until all activities to be performed thereunder have been completed; |
2.2.6 |
discuss the progress of research and Development activities under each mAb2 Development Plan and to agree any activities that Denali requests that F-star undertakes in relation to the conduct such mAb2 Development Plan in each case for each mAb2 until all activities to be performed thereunder have been completed; |
2.2.7 |
agree on a policy for publications, presentations or public disclosures related to a Selected Fcab during the Buy-out Option Period and to consider any proposed publications specifically; |
2.2.8 |
establish Working Groups as necessary; |
2.2.9 |
perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. |
2.3 |
No Further Responsibility upon Expiration of License Option Term. With respect to each Accepted Fab Target, upon expiration of the applicable License Option Term, the JSC shall have no further responsibility or authority under this Agreement with respect to any mAb2 for such Accepted Fab Target. |
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2.4 |
Disbandment. The JSC shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the JSC; (b) Licensor providing to Denali written notice of its intention to disband and no longer participate in the JSC; provided, that Licensor shall not give such written notice prior to Fcab Delivery in respect of each Accepted Fcab Target; or (c) the later of (i) Denali ceasing Technical Development and (ii) Fcab Delivery for the last Accepted Fcab Target to achieve Fcab Delivery (unless otherwise mutually agreed in writing) provided always that the responsibilities of the JSC that continue past such disbandment (including those under Sections 2.2.6 and 2.2.7) shall be undertaken by the Alliance Managers but otherwise in accordance with this ARTICLE 2. Notwithstanding anything herein to the contrary, upon the first to occur of the foregoing (a), (b) or (c), the JSC shall be terminated and shall have no further rights or obligations under this Agreement, and thereafter any requirement of either Party to provide Information or other materials to the JSC shall be deemed a requirement to provide such Information or other materials to the other Party, and any matters requiring agreement shall be subject to the mutual review and agreement of both Denali and Licensor. |
2.5 |
Location of Meetings. Prior to Fcab Delivery, on an Accepted Fcab Target-by-Accepted Fcab Target basis, the JSC shall meet every other month, or as otherwise agreed to by the Parties. After Fcab Delivery, on an Accepted Fcab Target-by-Accepted Fcab Target basis, the JSC shall meet every other month, or as otherwise agreed to by the Parties, only if Licensor is conducting any activities under the mAb2 Development Plan for the applicable Accepted Fcab Target. If Licensor is not conducting any activities under the mAb2 Development Plan for the applicable Accepted Fcab Target, then, until the Parties agree otherwise, the Parties respective Alliance Managers shall meet every Calendar Quarter with respect to such Accepted Fcab Target. All JSC meetings (and/or Alliance Manager meetings) will be by teleconference unless the Parties mutually agree otherwise. |
2.6 |
Conduct of Meetings. The chairperson of the JSC shall be responsible for calling meetings on no less than fifteen (15) Business Days notice. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items in advance of the applicable meeting as agreed upon by the JSC. An individual designated by the chairperson of the JSC shall prepare and circulate the minutes of each meeting for review and approval of the Parties within five (5) Business Days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JSC. |
2.7 |
Procedural Rules. The JSC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JSC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Representation by proxy shall be allowed. The JSC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. Employees or consultants of either Party that are not representatives of the Parties on the JSC may attend meetings of the JSC; provided, that such attendees (a) shall not vote or otherwise participate in the decision-making process of the JSC, and (b) are bound by obligations of confidentiality and non-disclosure that are substantially similar to those set forth in ARTICLE 11. |
2.8 |
Dispute Resolution. If the JSC cannot, or does not, reach consensus on an issue within the scope of the JSC, including any dispute arising in any subcommittee of the JSC, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed |
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to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within thirty (30) days after such issue was first referred to them, then (i) [***], (ii) [***]; and (iii) [***]. Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JSC, shall be resolved pursuant to Section 15.7. Amendments that would vary the resources required from either Party to the Fcab Discovery Plan shall require the mutual written consent of the Parties through the JSC or the Senior Officers. |
2.9 |
Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The JSC does not have the power to amend, modify, or waive compliance with this Agreement, which may only be amended or modified as provided in Section 15.9 or compliance with which may only be waived as provided in Section 15.11. |
2.10 |
Alliance Manager. Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of the JSC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an Alliance Manager). Each Party may replace its Alliance Manager at any time by notice in writing to the other Party. |
2.11 |
Interactions Between the JSC and Internal Teams. The Parties recognize that each Party possesses an internal structure (including various committees, teams and review boards) that will be involved in administering such Partys activities under this Agreement. Nothing contained in this Article shall prevent a Party from making routine day-to-day decisions relating to the conduct of those activities for which it has a performance or other obligations hereunder, in each case in a manner consistent with the then-current applicable plan and the terms and conditions of this Agreement. |
2.12 |
Working Groups. From time to time, the JSC may establish and delegate duties to sub-committees or directed teams (each, a Working Group) on an as-needed basis to oversee particular projects or activities (for example, joint project team, joint finance group, and/or joint intellectual property group). Each such Working Group shall be constituted and shall operate as the JSC determines; provided that each Working Group shall have equal representation from each Party, unless otherwise mutually agreed. Working Groups may be established on an ad hoc basis for purposes of a specific project or on such other basis as the JSC may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the JSC. In no event shall the authority of the Working Group exceed that specified for the JSC. All decisions of a Working Group shall be by consensus. Any disagreement between the designees of Denali and Licensor on a Working Group shall be referred to the JSC for resolution. |
2.13 |
Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JSC or other Working Group. |
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ARTICLE 3
TARGET NOMINATION
3.1 |
Selection of Accepted Fcab Targets. Denali has the right to nominate up to three Targets for approval as Accepted Fcab Targets. Prior to the Effective Date, TfR has been accepted by the Parties as the first such Accepted Fcab Target. Denali may nominate up to two further Accepted Fcab Targets as follows: |
3.1.1 |
The second and third Fcab are both to be directed against Targets which have been selected with the aim to facilitate transcytosis of the resulting mAb2 across the blood-brain barrier. |
3.1.2 |
The second and third Fcab Targets shall be nominated no later than thirty-six (36) months after the Effective Date provided always that if Licensor is requested to commence work on an Fcab Discovery Plan within [***] of the commencement of work on a prior Fcab Discovery Plan its obligation shall be subject to Licensor and/or F-star Ltd having the resources available to undertake such work. |
3.1.3 |
Denali shall nominate a proposed Accepted Fcab Target by providing a notice to Licensor (an Fcab Target Nomination Notice). Such notice must include the Entrez Gene ID, HUGO or official symbol and common synonyms (if available) for such Target. On receipt of such notice Licensor shall submit the Fcab to the Gatekeeper. Within ten (10) Business Days following the Gatekeepers receipt of the Fcab Target Nomination Notice with respect to a particular Target, the Gatekeeper shall verify whether such Target is on the list of Unavailable Fcab Targets and notify Licensor in writing. On receipt of a response from the Gatekeeper, Licensor shall notify Denali whether the Proposed Fcab Target is an Available Fcab Target. An Available Fcab Target is a Target in respect of which the Licensor is entitled to exercise the rights set out in the Gamma IP License to nominate as an Accepted Fcab Target and which is not an Unavailable Fcab Target. The Gatekeeper shall maintain an up-to-date list of Unavailable Fcab Targets (Unavailable Fcab Targets). An Unavailable Fcab Target shall only be a Target that is: |
(a) |
the subject of a pre-existing and bona fide internal Fcab program of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates on which Licensor, F-star GmbH, F-star Ltd or their respective Affiliates are then expending resources to the active research, Development or Commercialization of such program and have committed resources to the continued research, Development or Commercialization of such program in the upcoming twelve (12) months, |
(b) |
under an active, executed written agreement between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party that would preclude the grant of a license or exclusivity to such Target, or |
(c) |
the subject of bona fide, ongoing negotiations between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party where such negotiations specifically contemplate that a license or exclusivity would be granted to such Target and a written term sheet (or other written statement (including by email) of the scope and corresponding financial terms of such potential agreement) has been received or delivered by or to Licensor, F-star GmbH, F-star Ltd or their respective Affiliates. |
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3.1.4 |
If the Fcab Target is an Unavailable Fcab Target then, subject to Section 3.1.2, Denali shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target. |
3.1.5 |
If the Fcab Target is an Available Fcab Target then Licensor shall prepare an Fcab Discovery Plan for such proposed Accepted Fcab Target and shall submit such plan to Denali. If, based on the Fcab Discovery Plan, Licensor considers that the Fcab Target is not suitable for the generation of Fcabs and mAb2 it shall inform Denali and, the JSC shall meet within thirty (30) days of such Licensor informing Denali to consider the suitability of such Fcab Target for the generation of Fcabs. If the JSC agrees with Licensor then Denali shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target. |
3.1.6 |
Within thirty (30) days of submission of an Fcab Discovery Plan by Licensor to Denali the JSC shall meet to agree on the Fcab Discovery Plan; and on such agreement, the proposed Accepted Fcab Target shall become an Accepted Fcab Target. If the Parties are unable to agree upon the terms of the Fcab Discovery Plan, then provided a new Fcab Discovery Plan is substantially similar in scope to the TfR Fcab Discovery Plan (attached hereto as Exhibit 1.51), requires similar resources from Licensor and the Fcab Delivery Criteria have been agreed by both Parties (such agreement not to be unreasonably withheld or delayed), Licensor shall agree to such new Fcab Discovery Plan. |
3.2 |
On an Accepted Fcab Target-by-Accepted Fcab Target basis, at any point prior to the exercise of the Buy-out Option or, in the event that Denali does not exercise the Buy-out Option, at any time thereafter, Denali shall be entitled, subject to Section 14.9(c), to have up to eight (8) Fabs as Accepted Fab Targets for each then existing Accepted Fcab Target. Each nomination shall be specific to the Fcab Target in respect of which it was nominated. For the avoidance of doubt, the eight (8) Accepted Fab Targets shall include any Accepted Fab Target that is the subject of a License Option. Denali may abandon any Accepted Fab Target (including by reason of written notice by Denali of its decision to terminate the License Option Term pursuant to Section 14.5) by providing written notice identifying such abandoned Accepted Fab Target to Licensor and Gatekeeper, and such Accepted Fab Target shall cease to be an Accepted Fab Target on receipt of such notice by Licensor. If an Accepted Fab Target ceases to be an Accepted Fab Target, then, subject to Section 14.9(c), Denali would have the right to nominate another Accepted Fab Target with respect to the Accepted Fcab Target but, subject to Section 14.9(c), in no event shall there be more than eight (8) Accepted Fab Targets for each Accepted Fcab Target at any one time. |
3.3 |
To select an Accepted Fab Target, Denali shall provide the Gatekeeper with a confidential notice (the Fab Target Notice) that shall include: (i) a written description of each Target proposed for nomination as an Accepted Fab Target; and (ii) a written description of the Accepted Fcab Target in respect of which the Accepted Fab Target is being nominated and in the case of each Target such notice must include the Entrez Gene ID, HUGO UniProt, SwissProt and other gene/protein listing database and official symbol and common synonyms (if available) for such Target. Within ten (10) Business Days following the Gatekeepers receipt of the Fab Target Notice with respect to a particular Target, the Gatekeeper shall verify whether such Target is on the list of Unavailable Fab Targets and notify Denali in writing (Gatekeeper Notice) whether such proposed Target is or is not on the Unavailable Fab Target list. In addition to the foregoing clearance process, if a proposed Accepted Fab Target is an Incorporated Biologic, |
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then Denali and Licensor shall in good faith discuss and attempt to reach agreement on the scope of the Target definition with respect to such Incorporated Biologic, taking into account the requirement that exclusivity should be specific to the intended therapeutic approach (analogous to target based exclusivity for Accepted Fab Targets) and ability of the Gatekeeper to subsequently clear targets submitted by other licensees. If the Parties are unable to agree upon such scope, then the Parties shall resolve the Dispute in accordance with Section 15.7. An Unavailable Fab Target is a Target which is: |
(a) |
the subject of a pre-existing and bona fide internal program of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates on which Licensor, F-star GmbH, F-star Ltd or their respective Affiliates are then expending resources to the active research, Development or Commercialization of such program and have committed resources to the continued research, Development or Commercialization of such program in the upcoming twelve (12) months, |
(b) |
under an active, executed written agreement between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party that specifically includes a license grant or exclusivity to such Target, or |
(c) |
the subject of ongoing bona fide negotiations between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party where such negotiations specifically contemplate that a license or exclusivity would be granted to such Target and a written term sheet (or other written statement (including by email) of the scope and corresponding financial terms of such potential agreement) has been received or delivered by or to Licensor, F-star GmbH, F-star Ltd or their respective Affiliates. |
Notwithstanding the foregoing, prior to the expiration of the Buy-out Option Period, no Fab Target shall be an Unavailable Fab Target.
3.4 |
If the Gatekeeper Notice indicates that the Target is not on the Unavailable Target list, the proposed Target shall automatically be an Accepted Fab Target (Accepted Fab Target), and Denali shall, within thirty (30) days of the Gatekeeper Notice provide to Licensor a preliminary mAb2 Development Plan for the relevant mAb2 and on receipt of such plan by the Licensor, the Parties will have all rights and obligations hereunder in connection with such Accepted Fab Target (including exclusivity in accordance with ARTICLE 6) as of the date of receipt. If the Gatekeeper Notice indicates that the proposed Target is on the Unavailable Target list, then Denali shall have the right to nominate an alternative Accepted Fab Target in accordance with Section 3.3. In all cases, Denali acknowledges and agrees that the first person or entity to submit a Target Notice to the Gatekeeper for such Target will be entitled to be granted rights to such Target. |
ARTICLE 4
DEVELOPMENT AND REGULATORY
4.1 |
Technical Development Activities. Subject to Section 10.1, during the Technical Development Term Denali may conduct the Technical Development activities. Denali shall keep the JSC informed of such activities and the Parties shall discuss the same at each JSC meeting. Denali shall promptly provide to F-star Ltd a copy (in the form of a glycerol stock) of each Denali Library on its creation. Neither Licensor, nor F-star Ltd or F-star GmbH shall use any Denali Library to screen or identify Fcabs against any Accepted Fcab Targets. |
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4.2 |
Fcab Discovery Plan. Following agreement of an Fcab Discovery Plan by the JSC in respect of an Accepted Fcab Target Denali shall transfer to Licensor all of the information and materials set out in the relevant Fcab Discovery Plan. Licensor shall not be obliged to commence any work on the discovery of Fcabs unless and until it has received the materials (including antigen and assays) from Denali as provided for in the Fcab Discovery Plan. On receipt of such information and materials each Party shall, subject to Section 4.7 and subject to Section 9.2 carry out its responsibilities under the Fcab Discovery Plan. Any disputes related to preparation of or amendment to the Fcab Discovery Plan shall be handled in accordance with Section 2.8. |
4.3 |
Fcab Delivery. Licensor will be providing Fcab sequences to Denali as they are developed under the Fcab Discovery Plan and the Parties shall collaborate in good faith to identify which sequence is most likely to give the best chance of the Fcab meeting the Fcab Delivery Criteria. When Licensor reasonably considers that it has an Fcab that will meet the Fcab Delivery Criteria, it shall disclose to Denali the Fcab sequence (the Proposed Fcab), and notify Denali that the Fcab sequence is the Proposed Sequence, and shall also disclose the other information and materials provided for in the Fcab Discovery Plan to Denali. Denali shall have the Fcab Validation Period to review the data and to conduct the Fcab validation experiment(s) set out in the Fcab Discovery Plan for the Proposed Fcab. For clarity, (a) the Parties anticipate that Licensor will be providing Fcab sequences to Denali as they are developed under the Fcab Discovery Plan and leading up to the disclosure of the Proposed Fcab, (b) whilst the Parties shall collaborate in good faith to identify which sequence is most likely to give the best chance of the Fcab meeting the Fcab Delivery Criteria, [***], (c) all validation experiment(s) carried out for the purposes of this Section 4.3 and 9.11 shall be carried out in accordance with the protocol agreed by the JSC and (d) Denali is only obligated to conduct such Fcab validation experiment(s) [***] for an Fcab provided by Licensor for each Accepted Fcab Target, except that Denali will conduct [***] additional validation experiment(s) in accordance with Section 9.11. As soon as reasonably possible after completion of the validation experiment(s), Denali shall inform Licensor: |
4.3.1 |
that it agrees with Licensor that the Fcab Delivery Criteria have been sufficiently met then Fcab Delivery shall be deemed to have occurred on the date that Denali has made such determination after analysing the results of the validation experiment(s); or |
4.3.2 |
that it disagrees with Licensor that the Fcab Delivery Criteria have been sufficiently met, in which case it shall identify in what respect the Fcab Delivery Criteria have not been sufficiently met. Promptly on such occurrence the JSC shall meet to determine what (if any) further work is necessary to achieve the Fcab Delivery Criteria. The Parties may agree to amend the Fcab Discovery Plan for such Fcab. Notwithstanding the foregoing Denali may decide to declare that Fcab Delivery has occurred even if not all of the Fcab Delivery Criteria have been met. |
4.4 |
In the event that Licensor and Denali cannot agree that the Fcab Delivery Criteria have been met then the relevant Fcabs shall be provided to an independent laboratory agreed by both Parties and the relevant laboratory shall undertake the Fcab validation experiment(s) provided for in the Fcab Discovery Plan. The conclusions of the independent laboratory shall be binding on the Parties and if such laboratory concludes that the Fcab Delivery Criteria have been met then Fcab Delivery shall be deemed to have taken place on such date. [***] shall pay the costs of such independent laboratorys conduct of such Fcab validation experiment(s). |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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4.5 |
In the event that Denali does not respond within the Fcab Validation Period provided for in Section 4.3 the Fcab Delivery shall be deemed to have taken place. |
4.6 |
On Fcab Delivery or delivery of a Denali Fcab Notice in respect of a particular Fcab Denali shall prepare and deliver to Licensor the preliminary mAb2 Development Plans for the research and development of each mAb2 that Denali intends to generate in respect of such Fcab. Thereafter, during the License Option Term, Denali shall prepare and deliver to Licensor, at least once in every [***], updated mAb2 Development Plans. The content of such mAb2 Development Plans shall be in Denalis sole discretion and Licensor shall, subject to agreement of the activities in the relevant mAb2 Development Plan, provide technical support provided always that Licensor shall not be obligated to expend any resources or incur any costs in excess of [***] FTEs in each Calendar Year across all mAb2 Development Plans, without Licensors prior written consent, which consent shall be in its sole discretion. Each mAb2 Development Plan shall be the Denali Program Know-How. |
4.7 |
Diligence. |
4.7.1 |
Licensor shall use its Commercially Reasonable Efforts to carry out the Fcab Discovery Plan. Licensor shall provide Denali with [***] reports detailing the progress of its activities under Fcab Discovery Plan. |
4.7.2 |
Denali shall use Commercially Reasonable Efforts to perform its validation activities under the Fcab Discovery Plan. Denali shall provide Licensor with [***] reports detailing the progress of its activities under Fcab Discovery Plan |
4.7.3 |
The Parties acknowledge and agree that no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement. |
4.8 |
Technology transfer. Following Fcab Delivery of the first Fcab for each Accepted Fcab Target Licensor shall and shall procure that F-star GmbH and F-star Ltd shall, (to the extent any such Person Controls any such Information), make available to Denali any Information and materials specifically identified in the relevant Fcab Discovery Plan not already provided. |
4.9 |
Diligence. Denali shall use its Commercially Reasonable Efforts to carry out each mAb2 Development Plan. Denali shall provide an update on progress for each mAb2 Development Plan at each JSC meeting and each Alliance Managers meeting under Section 2.5. The Parties acknowledge and agree that no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement. |
4.10 |
Subcontracting. Licensor shall not subcontract its obligations under a Fcab Discovery Plan or a mAb2 Development Plan, except to Approved Subcontractors and Affiliates that have agreed in writing to be subject to the applicable terms and conditions of this Agreement, including the requirements under Section 4.7.1 and Section 4.7.2, the confidentiality provisions of ARTICLE 11, and provided that Licensor directly owns all Intellectual Property that may arise as required by ARTICLE 10. |
4.11 |
Regulatory Matters. As between the Parties, on a mAb2-by-mAb2 basis, following exercise of the License Option, Denali shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and to conduct communications with the Regulatory Authorities, for mAb2 or Licensed Products in the Territory (which shall include filings of or with respect to INDs or CTAs and other filings or communications with the Regulatory Authorities). |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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4.12 |
Records. Each Party shall, and shall ensure that its Affiliates and Approved Subcontractors, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law and regulatory guidance, which shall be complete and accurate and shall properly reflect all work done and results achieved in the performance of its obligations under each Fcab Discovery Plan and mAb2 Development Plan, which, after the Effective Date, shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such records shall be retained by each Party and its Affiliates and Approved Subcontractors for at least [***] after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Upon request, Licensor shall provide, and shall procure that its Affiliates and Approved Subcontractors provide, copies of the records it has maintained pursuant to this Section 4.12 to Denali. |
4.13 |
Pharmacovigilance. Within ninety (90) days after IND effectiveness of the first mAb2 or Licensed Product, the Parties shall determine if it is necessary to, and if so, enter into an agreement to initiate a process for the exchange of safety data (including post-marketing spontaneous reports received by each Party and its Affiliates) in a mutually agreed format in order to monitor the safety of the mAb2s or Licensed Products and to meet reporting requirements with any applicable Regulatory Authority. |
ARTICLE 5
COMMERCIALIZATION
5.1 |
In General. On a mAb2-by-mAb2 basis, following exercise of the License Option by Denali and for the remainder of the Term with respect to such mAb2, as between the Parties, Denali shall have the sole right to Develop and Commercialize (and shall control all aspects of Commercialization), itself or through its Affiliates or Sublicensees, mAb2 and Licensed Products in the Field and in the Territory at its own cost and expense (except as otherwise expressly set forth herein). |
5.2 |
Diligence. On a mAb2-by-mAb2 basis, following exercise of the License Option by Denali and for the remainder of the Term with respect to such mAb2, Denali will use Commercially Reasonable Efforts to Develop a Licensed Product in each Major Market and Commercialize a Licensed Product in each Major Market following receipt of Regulatory Approval in the applicable Major Market. Licensor acknowledges and agrees that, in addition to the foregoing, (a) Denali shall have the right to satisfy its diligence obligations under this Section 5.2 through its Affiliates or Sublicensees, and (b) nothing in this Section 5.2 is intended, or shall be construed, to require Denali to Develop or Commercialize (i) a specific mAb2 or Licensed Product or (ii) more than one (1) Licensed Product for any mAb2. If at any time Licensor has a reasonable basis to believe that Denali is in material breach of its material obligations under this Section 5.2, then Licensor shall so notify Denali, specifying the basis for its belief, and the Parties shall meet within thirty (30) days after such notice to discuss in good faith Licensors concerns and Denalis Development or Commercialization plans, as applicable, with respect to Licensed Product. If the Parties are unable to resolve such dispute within thirty (30) days after such notice, either Party may refer such dispute to the dispute resolution process set forth in Section 15.7. |
5.3 |
Reporting. After License Option exercise by Denali in respect of any Accepted Fab Target and for the remainder of the Royalty Term with respect to such Accepted Fab Target, (a) Denali shall provide Licensor with written progress reports within thirty (30) days following the end of each Calendar Year on the Development and Commercialization of mAb2 and Licensed Products, with such reports including key activities achieved, (b) the Parties will meet annually during the Term at mutually agreed upon times and locations, and (c) Denali will provide such further information as Licensor may reasonably request regarding the foregoing. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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5.4 |
Booking of Sales; Distribution. As between the Parties, Denali shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products in the Territory and to perform or cause to be performed all related services. Denali shall handle all returns, recalls, or withdrawals, order processing, invoicing, collection, distribution, and inventory management with respect to the Licensed Products in the Territory. |
5.5 |
Product Trademarks. As between the Parties, Denali shall have the sole right to determine and own the Product Trademarks to be used with respect to the Exploitation of the Licensed Products on a worldwide basis. |
5.6 |
Commercial Supply of mAb2 or Licensed Products. On a mAb2-by-mAb2 basis, following exercise of the License Option by Denali and for the remainder of the Term with respect to such Accepted Fab Target, as between the Parties, Denali shall have the sole right, at its expense, to Manufacture (or have Manufactured) and supply mAb2 and Licensed Products for commercial sale in the Territory by Denali and its Affiliates and Sublicensees. |
ARTICLE 6
EXCLUSIVITY
6.1 |
Exclusivity Prior to the Buy-out Option Deadline. During the Buy-out Option Period: |
6.1.1 |
Each of Licensor, F-star GmbH and F-star Ltd will not, and will cause its Affiliates not to, (i) directly or indirectly, Develop, Commercialize or Manufacture (a) an Antibody or any other molecule in either case incorporating a Selected Fcab or (b) any Selected Fcab as a stand-alone product in the Field, in each case in any country or other jurisdiction in the Territory, or (ii) license, authorize, appoint, or otherwise enable any Third Party to, directly or indirectly, Develop, Commercialize or Manufacture (a) an Antibody or any other molecule in either case incorporating a Selected Fcab or (b) any Selected Fcab, in each case in any country or other jurisdiction in the Territory. |
6.1.2 |
Each of Licensor, F-star GmbH and F-star Ltd will not, and will cause its Affiliates not to, take any action to solicit, initiate, encourage or assist the submission of any proposal, negotiation or offer from any Person relating to a Selected Fcab. |
6.1.3 |
Each of Licensor, F-star GmbH and F-star Ltd shall cease, and shall cause each of its Affiliates to cease, all Development on Antibody or any other molecule incorporating a Selected Fcab, except as expressly set forth in the Fcab Discovery Plan or a mAb2 Development Plan. |
6.2 |
Exclusivity after exercise of the Buy-out Option. In the event that Denali exercises the Buy-out Option within the Buy-out Option Period then from such exercise: |
6.2.1 |
Each of F-star GmbH and F-star Ltd will not, and will cause its Affiliates not to, (i) directly or indirectly, Develop, Commercialize or Manufacture (a) an Antibody or any other molecule incorporating a Selected Fcab or (b) any Selected Fcab as a stand-alone product in the Field, in each case in any country or other jurisdiction in the Territory, or (ii) license, authorize, appoint, or otherwise enable any Third Party to, directly or indirectly, Develop, Commercialize or Manufacture (a) an Antibody or any other molecule incorporating a Selected Fcab or (b) any Selected Fcab, in each case in any country or other jurisdiction in the Territory. |
6.2.2 |
Each of F-star GmbH and F-star Ltd will not, and will cause its Affiliates not to, take any action to solicit, initiate, encourage or assist the submission of any proposal, negotiation or offer from any Person relating to a Selected Fcab. |
Confidential
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6.2.3 |
Each of F-star GmbH, and F-star Ltd shall cease, and shall cause each of its Affiliates to cease, all internal Development on any Antibody or any other molecule incorporating Selected Fcab, except as expressly set forth in the Fcab Discovery Plan or a mAb2 Development Plan. |
6.3 |
Exclusivity on the lapse of the Buy-out Option. Without limiting Sections 6.1 and 6.2, on an Accepted Fab Target-by-Accepted Fab Target basis, following the expiry of the Buy-out Option Period without the exercise of the Buy-out Option until the later of (a) the termination or expiration of the License Option Term in respect of the relevant Accepted Fab Target without the exercise of the License Option for such Accepted Fab Target during the License Option Term or (b) if the applicable License Option is exercised, the termination or expiration of this Agreement with respect to such Accepted Fab Target, each of Licensor, F-star GmbH and F-star Ltd shall not, and shall cause its Affiliates not to, (i) for itself or themselves, Develop, Commercialize or Manufacture any Antibody or any other molecule containing Fcab and Fab domains which specifically bind the relevant Accepted Fcab Target and the relevant Accepted Fab Target respectively in any Field and in any country in the Territory, or (ii) license, authorize, appoint, fund or otherwise enable any Third Party to, directly or indirectly, Develop, Commercialize or Manufacture any such Antibody or any other such molecule. |
6.4 |
Exclusivity in respect of Platform IP assigned by Denali to Licensor. Each of Licensor, F-star GmbH and F-star Ltd hereby covenant that they shall not, and shall cause its Affiliates not to: (i) use or license, authorize, appoint, fund or otherwise enable any Third Party to use, any Platform IP that is assigned by Denali to any of them pursuant to this Agreement; or (ii) use any Denali Library that is provided pursuant to this Agreement to any of them; in each case to Develop, Commercialize or Manufacture any Fcab which is intended for the transport of a product across the blood-brain barrier. This covenant shall survive the expiry or termination of this Agreement for whatever reason. |
6.5 |
For purposes of clarity, following the expiration of Buy-out Option Period without any exercise of the Buy-out Option by Denali, Licensor, F-star GmbH and F-star Ltd reserve all rights to Develop, Commercialize or Manufacture, and license, authorize, appoint, and otherwise enable any Third Party to Develop, Commercialize or Manufacture any Antibody containing any Selected Fcab other than a Denali Fcab or Joint Fcab for use with any Target other than an Accepted Fab Target. |
6.6 |
Licensor, F-star GmbH and F-star Ltd acknowledge that Denali and its Affiliates are in the business of Exploiting products, and nothing in this Agreement shall be construed as restricting such business or preventing Denali and its Affiliates from Exploiting any products that may be competitive with any Fcab, mAb2 or Licensed Products. |
Confidential
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ARTICLE 7
OPTIONS
7.1 |
Buy-out Option. At any time during the Buy-out Option Period Denali may exercise the Buy-out Option in the manner set out in the Buy-out Option Agreement. Denali may extend the Buy-out Option Period by an additional [***] months by written notice to Licensor such notice to be received no later than the expiry of the earlier of (a) the [***] month after the first Fcab Delivery or (b) the [***] month after Denali Fcab Notice, in each case subject to Denali making the following payment to Licensor prior to [***]: (x) [***] if TfR is the only Accepted Fcab Target, or (y) [***] if there is at least one (1) other Accepted Fcab Target in addition to TfR. |
7.2 |
License Option. Licensor hereby grants to Denali, on an Accepted Fab Target-by-Accepted Fab Target basis, the exclusive right and option, exercisable at Denalis sole discretion, to obtain and exercise the exclusive licenses under the Licensor Background IP, the Licensor Program IP and Joint Program IP as set forth in Section 8.1, with respect to the Exploitation of a Licensed Product containing a mAb2 to such Accepted Fab Target in the Field in the Territory (each, a License Option). Denali may exercise a License Option by providing written notice to Licensor of its election to exercise such License Option at any time during the relevant License Option Term. Upon delivery of such written notice, such licenses as set forth in Section 8.1 with respect to the Exploitation of any mAb2 or Licensed Product in the Field in the Territory shall, and hereby do, automatically become effective. A license granted pursuant to this Section 7.2 shall be a mAb2 License. |
7.3 |
License Option Exercise Payment. If Denali exercises the License Option for a particular mAb2, then Denali shall pay to Licensor a non-refundable payment in the amount of [***] in accordance with Section 9.7. In the event that Denali does not exercise a given License Option with respect to a mAb2 in accordance with the foregoing provisions of this Section 7.3, then Denalis option to obtain the exclusive licenses set forth in Section 8.1 with respect to such mAb2 shall expire upon the expiration of the applicable License Option Term (provided, however, that the expiration of a given License Option shall not affect any other License Option of Denali). |
7.4 |
Lapse of the relevant License Option. If Denali has not exercised its License Option: |
7.4.1 |
for a particular Accepted Fab Target within the relevant License Option Term for that Accepted Fab Target, or has terminated the mAb2 License in respect of an Accepted Fab Target, the relevant Accepted Fab Target will no longer be an Accepted Fab Target hereunder and all Licensors obligations with respect to such Accepted Fab Target, including all options, licenses and other rights granted by Licensor hereunder with respect to such Accepted Fab Target and the corresponding mAb2, shall immediately terminate without any further action required on the part of either Party. For the avoidance of doubt such expiry or termination of a License Option or termination of the mAb2 License shall not affect Licensors rights in relation to the corresponding Accepted Fcab Target or related Fcabs or, subject to Section 14.9(c), reduce the number of Accepted Fab Targets that Denali may maintain at any time; and |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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7.4.2 |
for any Accepted Fab Target for a particular Accepted Fcab Target within the relevant License Option Terms or has terminated all its mAb2 Licenses in respect of Accepted Fab Targets for that particular Accepted Fcab Target, the relevant Accepted Fab Targets and the particular Accepted Fcab Target will no longer be Accepted Fab Targets or an Accepted Fcab Target hereunder and all Licensors obligations with respect to such Accepted Fab Target for that particular Accepted Fcab Target, including all options, licenses and other rights granted by Licensor hereunder with respect to such Accepted Fab Target and any corresponding mAb2, shall immediately terminate without any further action required on the part of either Party. For the avoidance of doubt such expiry or termination of a License Option or termination of a mAb2 License shall not affect Licensors rights in relation to the corresponding Accepted Fcab Target or related Fcabs or, subject to Section 14.9(c), reduce the number of Accepted Fab Targets that Denali may maintain at any time. |
7.5 |
On an Accepted Fab Target-by-Accepted Fab Target basis, immediately upon expiration of the applicable License Option Term or termination of the relevant License Option, or termination of the relevant mAb2 License each Party will retain the non-exclusive right with the right to grant sub-licenses, under such Partys respective interest in the Joint Program IP to Exploit any and all molecules, products or services without the consent of, or compensation or accounting to, the other Party. |
Confidential
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ARTICLE 8
GRANT OF RIGHTS
8.1 |
Grants by Licensor to Denali. Subject to Sections 8.6 and 8.8, Licensor hereby grants to Denali: |
8.1.1 |
subject to Section 10.1.1, during the Technical Development Term, a non-exclusive license, with no right to grant sublicenses (except as provided below), under the Licensor Background IP (existing as of the Effective Date), Licensor Program IP and Licensors interest in the Joint Program IP, solely for the purpose of undertaking Technical Development solely for the purposes of generating, identifying or improving potential Fcabs against Accepted Fcab Targets. |
8.1.2 |
in relation to each Fcab, from the Effective Date until Fcab Delivery of the relevant Fcab, a non-exclusive license, with no right to grant sublicenses (except as provided below), under the Licensor Background IP, Licensor Program IP and Licensors interest in the Joint Program IP, solely for the purpose of undertaking any tasks ascribed to Denali in the relevant Fcab Discovery Plan. The foregoing license shall include the right by Denali to grant sublicenses solely to entities that are provide development services for Denali (e.g. CROs) provided always that all intellectual property created by any such Sublicensee in the course of undertaking such services shall be owned by Denali. |
8.1.3 |
on an Accepted Fab Target-by-Accepted Fab Target basis, from the date that the relevant Fab Target becomes an Accepted Fab Target until the expiration of the applicable License Option Deadline, an exclusive license (even to Licensor), with the right to grant sublicenses in accordance with Section 8.6, under the Licensor Background IP, Licensor Program IP and Licensors interest in the Joint Program IP, solely to conduct the Development of the relevant mAb2 and to incorporate such mAb2 in Licensed Products in each case, in the Field and in the Territory; |
8.1.4 |
on an Accepted Fab Target-by-Accepted Fab Target basis, contingent upon Denalis exercise of the applicable License Option pursuant to Sections 7.2 and 7.3 and continuing for the remainder of the Term with respect to such mAb2 an exclusive, even as to Licensor, license, with the right to grant sublicenses in accordance with Section 8.6, under the Licensor Background IP, Licensor Program IP and Licensors interest in the Joint Program IP, to Exploit mAb2 and to incorporate such mAb2 in Licensed Products in each case, in the Field in the Territory; provided that, in relation to any Patents or Know-How which is licensed to Licensor on a non-exclusive basis, such licenses and rights granted to Denali are an exclusive license of such rights as Licensor may have. |
Confidential
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8.2 |
Grants by F-star Ltd to Denali. Subject to Sections 8.6 and 8.8, F-star Ltd hereby grants to Denali: |
8.2.1 |
subject to Section 10.1.1, during the Technical Development Term, a non-exclusive license, with no right to grant sublicenses (except as provided below), under the Platform IP, solely for the purpose of undertaking Technical Development solely for the purposes of generating, identifying or improving potential Fcabs against Accepted Fcab Targets; |
8.2.2 |
in relation to each Fcab, from the Effective Date until Fcab Delivery of the relevant Fcab, a non-exclusive license, with no right to grant sublicenses (except as provided below), under the Platform IP, solely for the purpose of undertaking any tasks ascribed to Denali in the relevant Fcab Discovery Plan. The foregoing license shall include the right by Denali to grant sublicenses solely to entities that are provide development services for Denali (e.g. CROs) provided always that all intellectual property created by any such Sublicensee in the course of undertaking such services shall be owned by Denali; |
8.2.3 |
on an Accepted Fab Target-by-Accepted Fab Target basis, from the date that the relevant Fab Target becomes an Accepted Fab Target until the expiration of the applicable License Option Deadline, an exclusive license (even to F-star Ltd), with the right to grant sublicenses in accordance with Section 8.6, under the Platform IP, solely to conduct the Development of the relevant mAb2 and to incorporate such mAb2 in Licensed Products in each case, in the Field and in the Territory; and |
8.2.4 |
on an Accepted Fab Target-by-Accepted Fab Target basis, contingent upon Denalis exercise of the applicable License Option pursuant to Sections 7.2 and 7.3 and continuing for the remainder of the Term with respect to such mAb2 an exclusive, even as to F-star Ltd, license, with the right to grant sublicenses in accordance with Section 8.6, under the Platform IP, to Exploit mAb2 and to incorporate such mAb2 in Licensed Products in each case, in the Field in the Territory. |
8.3 |
Grants by Denali. |
8.3.1 |
Denali hereby grants to Licensor, from the Effective Date until the expiration of the applicable License Option Deadline, a non-exclusive license, with the right to grant sublicenses to Affiliates and Approved Subcontractors, under the Denali Background IP and Denali Program IP and Denalis interest in the Joint Program IP, solely to conduct the activities under the Fcab Discovery Plan and the mAb2 Development Plan in the Territory. |
8.3.2 |
If Denali has not exercised its Buy-out Option within the Buy-out Option Period Denali shall, and hereby does, grant to Licensor (without any further action required on the part of Denali) a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses through multiple tiers, under Denali Background IP, Denali Program IP and any Joint Program IP reasonably necessary to Exploit, and for the sole purpose of Exploiting, any Fcabs (other than a Denali Fcab) against an Accepted Fcab Target and/or any Antibody to the extent containing such Fcab (but not a Denali Fcab or Joint Fcab), but expressly excluding from such license grant any rights to (a) any mAb2, (b) any Fabs or (c) any Accepted Fab Targets, and subject to: (i) ARTICLE 6; and (ii) to any Licenses granted to Denali in Section 8.1; in the Field in the Territory. |
Confidential
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8.3.3 |
Denali shall, and hereby does, grant to Licensor and to F-star Ltd (without any further action required on the part of Denali) a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses through multiple tiers, under Denali Background IP, Denali Program IP and any Joint Program IP in each case which Denali used in conducting Technical Development and which is reasonably necessary to Exploit, and for the sole purpose of Exploiting, any Platform IP subject to: (i) ARTICLE 6 (including Section 6.4, which terms shall also apply to the rights granted in this Section); and (ii) to any Licenses granted to Denali in Section 8.1; in the Field in the Territory. |
8.4 |
Know-How License. |
8.4.1 |
Denali hereby grants to Licensor from the Effective Date a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses through multiple tiers, under Denali Background Know-How, Denali Program Know-How and any Joint Program Know-How to the extent that such Know-How: (i) was disclosed to the Licensor during the Term; and (ii) does not comprise any sequence of a Fab which is confidential to Denali (including the sequence of a Denali Fcab); for all purposes in all fields. For clarity, the license grant in this Section 8.4.1 does not include rights under any Patents. |
8.4.2 |
Licensor hereby grants to Denali from the Effective Date a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses through multiple tiers, under Licensor Background Know-How,Licensor Program Know-How and any Joint Program Know-How in each case to the extent that such Know-How: (i) with respect to Know-How other than Platform Know-How, was disclosed to Denali during the Term; and (ii) does not comprise any sequence of a Fcab which is confidential to Licensor unless otherwise licensed to Denali hereunder; for all purposes in all fields. For clarity, the license grant in this Section 8.4.2 does not include rights under any Patents. |
8.4.3 |
F-star Ltd hereby grants to Denali from the Effective Date a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses through multiple tiers, under Platform Know-How to the extent that such Know-How does not comprise any sequence of a Fcab which is confidential to F-star Ltd unless otherwise licensed to Denali hereunder for all purposes in all fields. For clarity, the license grant in this Section 8.4.3 does not include rights under any Patents. |
8.5 |
Platform IP License. F-star Ltd hereby grants to Denali a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses through multiple tiers, under the Platform IP to Exploit any product or practice any method in each case in connection with the Exploitation of products for the delivery of therapeutics across the blood brain barrier and provided that such license grant does not include the right to, prior to the later of (i) the last to expire of any Platform Patents and (ii) [***]: (a) [***] in relation to the introduction of new antigen binding sites (where the reference to new means that the binding site was not obtained by modifying the binding site that is native to that loop) within the binding loops of a constant domain of an Antibody; or (b) grant a sublicense to the Platform IP without also granting rights in relation to specific products that have been or are to be developed by Denali and which products are also covered by Denali Intellectual Property. |
Confidential
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8.6 |
Sublicenses. Denali shall have the right to grant sublicenses, through multiple tiers of sublicenses, under the licenses granted in Section 8.1, to Sublicensees and Distributors; provided that any such sublicenses shall (a) be in writing, (b) be consistent with the terms and conditions of this Agreement, and (c) require the applicable Sublicensee or Distributor to comply with all applicable terms of this Agreement. Denali shall be responsible for the performance of any Sublicensee or Distributor as if such Sublicensee or Distributor were Denali hereunder. [***]. |
8.7 |
Distributorships. Denali and its Affiliates shall have the right, in their sole discretion, to appoint any Third Parties, in the Territory or in any country or other jurisdiction of the Territory, to distribute, market, and sell the Licensed Products, in circumstances where the Person purchases Licensed Products from Denali or its Affiliates or a Sublicensee of either of them. Where Denali or its Affiliates appoints such a Third Party, that Person shall be a Distributor for purposes of this Agreement and Net Sales from such Distributors shall include all of the amounts received from such Third Parties ([***]) in consideration for the sale of any Licensed Products. For clarity, if Denali grants to a Third Party any rights under applicable Intellectual Property to make, use, sell, offer for sale or import a Licensed Product, then such Third Party shall be a Sublicensee and not a Distributor. |
8.8 |
Retention of Rights. Notwithstanding the exclusive licenses granted to Denali pursuant to Section 8.1, Licensor retains the right for itself, F-star Ltd and F-star GmbH and their Affiliates and licensees to practice under the Licensor Background IP and Licensor Program IP and Licensors interest in the Joint Program IP outside the scope of the licenses granted herein and to perform (and to sublicense Approved Subcontractors to perform to the extent not prohibited hereunder) its obligations under this Agreement. Except as expressly provided herein, Licensor grants no other right or license, including any rights or licenses to the Licensor Background IP, Licensor Program IP, or any other Patent or intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel, or otherwise. Subject to any licenses granted herein, Licensor may, without the prior consent of Denali, licence, assign, mortgage, charge or otherwise deal in its share in any Joint Program IP. |
8.9 |
No Implied Rights. Except as expressly provided herein, Denali grants no other right or license, including any rights or licenses to the Denali Background IP, Denali Program IP, Denalis interest in the Joint Program IP or any other Patent or intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel or otherwise. Subject to any licenses granted herein, Denali may, without the prior consent of Licensor, licence, assign, mortgage, charge or otherwise deal in its share in any Joint Program IP. |
8.10 |
Confirmatory Patent License. Each Party shall, if requested to do so by the other, promptly enter into confirmatory license agreements in the form or substantially the form reasonably requested by the requesting Party for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as requesting Party considers appropriate. |
8.11 |
Financial Obligations. All financial obligations of Licensor, including royalties, due from Licensor to Third Parties for the Licensor Background IP, Licensor Program IP or Licensors interest in any Joint Program IP is the sole responsibility of Licensor and all financial obligations of Denali, including royalties, due from Denali to Third Parties for the Denali Background IP (provided that if a sublicense to Licensor under the Denali Background IP (other than under Section 8.3.1) requires or triggers a payment obligation, then Licensor is responsible to pay such payment obligation), Denali Program IP or Denalis interest in any Joint Program IP is the sole responsibility of Denali. |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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8.12 |
Licensor In-Licenses. Licensor shall timely pay in full all amounts required to be paid by Licensor, and timely perform in full all obligations required to be performed by Licensor, under all Licensor In-Licenses. Licensor promptly shall provide Denali with copies of all notices and other deliveries received under the Licensor In-Licenses. Without the prior express written consent of Denali, Licensor shall not (and shall take no action or make no omission to) modify or waive any provision of any Licensor In-License that could impair the value of the licenses to Denali herein, or to terminate or have terminated any Licensor In-License. If any Licensor In-License is terminated for any reason other than in circumstances where Denali is in breach of this Agreement, Licensor shall use its Commercially Reasonable Efforts to ensure that the licensor thereunder, shall grant a direct license under the Licensor Background IP to Denali containing terms and conditions no less favorable to Denali than the payment terms of such Licensor In-License. Denali shall abide, and will cause all its Affiliates and applicable Sublicensees to abide, by all requirements of the Licensor In-Licenses in all respects, to the extent applicable to Sublicensees thereunder. |
ARTICLE 9
PAYMENTS AND RECORDS
9.1 |
License Fees. Within fifteen (15) days of the Effective Date, Denali shall pay Licensor the non-refundable, non-creditable sum of Five Million Five Hundred Thousand Dollars ($5,500,000). |
9.2 |
Research and Development Costs. Denali shall be responsible for FTE costs incurred by Licensor and F-star Ltd in relation to each Fcab Discovery Plan and mAb2 Development Plan as set forth in the applicable Fcab Discovery Plan or mAb2 Development Plan, and subject to the following. For the TfR Fcab Discovery Plan Denali will fund [***] FTEs per Calendar Quarter. Payment of such sums shall be paid in advance in accordance with the budget/FTE allocation agreed as a part of each Fcab Discovery Plan and mAb2 Development Plan. Promptly following the end of each Calendar Quarter, Licensor shall provide to Denali a report with the actual costs incurred during such Calendar Quarter, and the Parties shall review those actual costs against the budget/FTE allocation. Following such review, and upon mutual written agreement between the Parties, the budget/FTE allocation may be increased or decreased. On an Accepted Fcab Target-by-Accepted Fcab Target basis, Denalis obligation to fund such FTE costs incurred in relation to a Fcab Discovery Plan shall terminate on the earlier of (a) [***], and (b) [***]; provided that upon mutual written agreement following discussion at the JSC, Denali may extend such commitment to fund costs for a particular Fcab Discovery Plan. |
9.3 |
Fcab Selection Payment. Denali shall pay to Licensor the sum of [***] within [***] following the date that a Target becomes an Accepted Fcab Target according to Section 3.1.6. For clarity, the foregoing payment is not due with respect to the first Accepted Fcab Target TfR. |
9.4 |
Fcab Exclusivity Fee. Denali shall to pay Licensor the sum of [***] per calendar month commencing on the first day of the month after the [***] and ending on the first day of the month in which the earlier of the following occurs: (i) [***]; (ii) [***] or (iii) that Target ceasing to be an Accepted Fcab Target. Licensor shall provide to Denali an invoice on or before the first day of the relevant calendar month with the amount of the applicable exclusivity fees for such calendar month and Denali shall pay such amount within thirty (30) days after receipt of invoice. |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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9.5 |
Fab Exclusivity Fee. Denali shall to pay Licensor the sum of [***] per calendar month in respect of each Accepted Fab Target commencing on the first day of the month after the [***] and ending on the first day of the month in which the earlier of the following occurs: (i) [***]; (ii) [***] or (iii) that Target ceasing to be an Accepted Fab Target. Licensor shall provide to Denali an invoice on or before the first day of the relevant calendar month with the amount of the applicable exclusivity fees for such calendar month and Denali shall pay such amount within thirty (30) days after receipt of invoice. |
9.6 |
Fcab Milestones. In partial consideration of the rights granted by Licensor to Denali hereunder and subject to the terms and conditions set forth in this Agreement, Denali shall pay to Licensor, on an Accepted Fcab Target basis, the following one-time (per Accepted Fcab Target), non-refundable, non-creditable milestone payments within thirty (30) days after: |
9.6.1 |
[***]: (a) [***] or (b) [***]; |
9.6.2 |
[***]: (i) [***], and (ii) [***]; provided that this additional payment under clause (ii) shall only be due one (1) time with respect to a particular Fcab. |
9.7 |
License Option Exercise Fee. In partial consideration of the rights granted by Licensor to Denali hereunder and subject to the terms and conditions set forth in this Agreement, Denali shall pay to Licensor the non-refundable, non-creditable sum of [***] within thirty (30) days after the exercise of each License Option. |
9.8 |
Development Milestones. In partial consideration of the rights granted by Licensor to Denali hereunder and subject to the terms and conditions set forth in this Agreement, Denali shall pay to Licensor the non-refundable, non-creditable milestone payments within thirty (30) days after the achievement by Denali, its Affiliate or Sublicensee of each of the following milestones for [***] Licensed Products that the manufacture, sale or use is covered by a Valid Claim of the Licensor Background Patents and/or Licensor Program Patents and/or the Denali Program Patents and achieve such milestone event regardless whether they are the subject of the same or a different mAb2 Licenses exercised by Denali (subject to the final paragraph of this Section 9.8), calculated as follows: |
9.8.1 |
upon [***]; |
9.8.2 |
upon [***]; |
9.8.3 |
upon [***]; |
9.8.4 |
upon [***]; |
9.8.5 |
upon [***]; and |
9.8.6 |
upon [***]; |
9.8.7 |
upon [***]; |
Each milestone payment in this Section 9.8 shall be payable only upon the achievement of such milestone by [***] mAb2 or Licensed Products to achieve such milestone event and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different mAb2 or Licensed Product, subject to the following. If Denali has made one of the foregoing milestone payments for a Licensed Product that contains a mAb2 to a particular Accepted Fcab Target and Accepted Fab Target and subsequently achieves the same milestone with a different Licensed Product containing a mAb2 to the same Accepted Fcab Target and Accepted Fab Target, then Denali shall not owe a milestone for such subsequent achievement.
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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9.9 |
Sales-Based Milestones. In partial consideration of the license rights granted by Licensor to Denali hereunder in the event that the Net Sales of a particular Licensed Product during the applicable Royalty Term made by Denali or any of its Affiliates or Sublicensees in a given Calendar Year exceeds a threshold (each, an Annual Net Sales Milestone Threshold) set forth in the left-hand column of the table immediately below (the Annual Net Sales-Based Milestone Table), Denali shall pay to Licensor a milestone payment (each, a Annual Net Sales-Based Milestone Payment) in the corresponding amount set forth in the right-hand column of the Annual Net Sales-Based Milestone Table. In the event that in a given Calendar Year more than one (1) Annual Net Sales Milestone Threshold is exceeded, Denali shall pay to Licensor a separate Annual Net Sales-Based Milestone Payment with respect to each Annual Net Sales Milestone Threshold that is exceeded in such Calendar Year. Each such milestone payment shall be non-refundable and due within thirty (30) days of the date on which such milestone was achieved. |
Threshold Annual Net Sales Levels |
Payment
Amount |
|
[***] |
[***] | |
[***] |
[***] |
Each milestone payment in this Section 9.9 shall be payable:
(a) |
on a Licensed Product-by-Licensed Product basis such that it shall be payable upon the first achievement of such milestone in respect of a Licensed Product in a given Calendar Year, and no amounts shall be due for subsequent or repeated achievements of such milestone by the same Licensed Product in subsequent Calendar Years; and |
(b) |
shall be payable only [***] times, upon the achievement of such milestone in respect of [***] Licensed Products to achieve such milestone event and no amounts shall be due for the achievement of such milestone by [***] Licensed Products to achieve such milestone event. |
The maximum aggregate amount of Annual Net Sales-Based Milestone Payments payable by Denali is Six Hundred and Fifty Million Dollars ($650,000,000).
9.10 |
Royalties. As further consideration for the rights granted to Denali hereunder, subject to Section 9.10.2, commencing upon the First Commercial Sale of a Licensed Product in the Territory, on a Licensed Product-by-Licensed Product basis, Denali shall pay to Licensor a royalty on Net Sales of each Licensed Product during the Royalty Term in the Territory (excluding Net Sales of each Licensed Product in any country or other jurisdiction in the Territory for which the Royalty Term for such Licensed Product in such country or other jurisdiction has expired) during each Calendar Year at the following rates: |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Net Sales in the Territory of a Particular Licensed Product in a Calendar Year | Royalty Rate | |
For that portion of aggregate Net Sales of a particular Licensed Product in the Territory during a Calendar Year less than [***] |
[***] | |
For that portion of aggregate Net Sales of a particular Licensed Product in the Territory during a Calendar Year equal to or greater than [***] but less than [***] |
[***] | |
For that portion of aggregate Net Sales of a particular Licensed Product in the Territory during a Calendar Year equal to or greater than [***] |
[***] |
With respect to each Licensed Product in each country or other jurisdiction in the Territory, from and after the expiration of the Royalty Term for such Licensed Product in such country or other jurisdiction, Net Sales of such Licensed Product in such country or other jurisdiction shall be excluded for purposes of calculating the Net Sales thresholds and ceilings set forth in this Section 9.10.
9.10.1 |
Royalty Term. Denali shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country or other jurisdiction after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. |
9.10.2 |
Reductions. In the event that, for the purpose of Exploiting a mAb2 or Licensed Product, Denali reasonably decides after good faith consultation with patent counsel that the Exploitation of a mAb2 or a Licensed Product is likely to infringe one or more of the Patents falling within clauses (a) or (b) below which are owned by a Third Party, and if Denali obtains a License under any such Patents owned by a Third Party that: |
(a) |
has specific claims which would be infringed by or prevent the practising of the inventions specifically as claimed in [***]; or |
(b) |
specifically claims or covers the sequences of the binding loops of the Fcab portion of the relevant mAb2 or claims or covers the use of such binding loops; |
then Denali shall be entitled to deduct [***] of the amount of royalties actually paid by Denali to such Third Party from the royalties paid to Licensor in respect of that mAb2 only in any given Calendar Quarter pursuant to Section 9.10, provided always that nothing in this Section 9.10.2 shall operate to reduce the amount of Royalties otherwise payable to Licensor in respect of that mAb2 to less than fifty percent (50%) of the Royalties provided for in Section 9.10.
9.10.3 |
Generic Competition. In the event that, in respect of a given mAb2, on a country by country basis a Third Party has obtained Regulatory Approval for and launches an Antibody which comprises (i) a binding region of a constant domain that binds to the Accepted Fcab Target, and the making, using, selling, offering for sale or importation of such binding region or constant domain either (a) where such Patents Rights in such country covering such mAb2 have expired or been held invalid, infringed a Valid Claim of one or more of the Licensor Background Patents, Licensor |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Program Patents, Platform Patents, Denali Program Patents or Joint Program Patents in that country, or (b) where there were no such Patents in such country covering such mAb2, would have infringed a Valid Claim of one or more of the Licensor Background Patents, Licensor Program Patents, Platform Patents, Denali Program Patents or Joint Program Patents in the U.S. if such mAb2 was made, used, sold, offered for sale or imported into the U.S.; and (ii) a Fab that binds to the Accepted Fab Target (or in the case of a Incorporated Biologic, a Fab that incorporates the Accepted Fab Target) of the relevant mAb2, and all of the Licensor Background Patents, Licensor Program Patents, Platform Patents, Denali Program Patents and Joint Program Patents in such country which covered or claimed the relevant mAb2 or the Fcab that comprises part of such mAb2 have expired or are held invalid (or there were no such Patents issued in such country); then the royalty rate on the relevant mAb2 (a) shall be reduced [***] if the binding region of such Third Party Antibody comprises binding loops with the same amino acid sequence as the binding loops in the Fcab of the relevant mAb2, or (b) shall be reduced [***] if the binding region of such Third Party Antibody comprises binding loops with a different amino acid sequence than the binding loops in the Fcab of the relevant mAb2. |
9.11 |
Denali Fcab Payment Reductions. In the event that for a given Accepted Fcab Target, (i) the Proposed Fcab provided by the Licensor to Denali fails to meet the Fcab Delivery Criteria for that Accepted Fcab Target (or Licensor was otherwise unable to provide to Denali a Proposed Fcab during the [***] period after Denali has transferred to F-star all reagents and assays for F-star to conduct the antigen validation (e.g. conclusion of Step 1, Antigens of Schedule 1.51 for the TfR Fcab Discovery Plan) under the applicable Fcab Discovery Plan); (ii) Denali has provided to Licensor the Denali Fcab Notice with respect to a Denali Fcab for such Accepted Fcab Target; and (iii) Licensor does not provide to Denali an Fcab against that Accepted Fcab Target which meets the relevant Fcab Delivery Criteria within the later of (a) [***] after Denali has transferred to F-star all reagents and assays for F-star to conduct the antigen validation (e.g. conclusion of Step 1, Antigens of Schedule 1.51 for the TfR Fcab Discovery Plan) under the applicable Fcab Discovery Plan, and (b) [***] after the date Denali provides to Licensor the Denali Fcab Notice (the Fcab Disclosure Period); then all of the payments set out in Sections 7.3, 9.6, 9.7, 9.8, 9.9 and 9.10 in respect of the relevant Fcab and any such payment in respect of a mAb2 incorporating such Fcab shall be reduced by [***] such that the amount payable is [***] of the amount set out in those sections. If the Proposed Fcab for an Accepted Fcab Target failed to meet the Fcab Delivery Criteria, and Licensor subsequently provides to Denali during the Fcab Disclosure Period another Licensor Fcab for validation testing, then Denali shall only be obligated to conduct [***] additional validation experiment(s) for such additional Licensor Fcab, and if such additional Licensor Fcab does not meet the Fcab Delivery Criteria, then Licensor shall be responsible to reimburse Denali for its costs to conduct such additional validation experiment(s) in respect of [***] Licensor Fcab only). In addition, Licensor shall be entitled (but not obliged) to conduct, at its own cost, [***] validation experiment(s) for [***] Licensor Fcab in addition to the [***] Licensor Fcabs that are subject to the validation experiments carried out by Denali, provided such validation experiment(s) is carried out within the Fcab Disclosure Period. The above reduction shall not apply: |
9.11.1 |
if Licensor delivers the sequence of an Fcab against such Accepted Fcab Target which within such period meets or subsequently is found to meet the Fcab Delivery Criteria prior to expiration of the Fcab Disclosure Period for such Accepted Fcab Target, and, upon the date of Fcab Delivery of such an Fcab, Denali shall pay the difference between the amounts that were paid in respect of the Denali Fcab and the amounts that would have been paid if Denali had selected a Licensor Fcab; |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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9.11.2 |
if, notwithstanding that the Fcab against such Accepted Fcab Target delivered by Licensor did not meet the relevant Fcab Delivery Criteria, Denali nevertheless selects a Licensor Fcab or Joint Fcab for the development of mAb2 as evidenced by initiation of GMP manufacture for a Licensed Product that incorporates such Licensor Fcab or Joint Fcab; or |
9.11.3 |
in respect of any mAb2 which contains a Licensor Fcab or a Joint Fcab. |
9.12 |
Royalty Payments and Reports. Denali shall calculate all amounts payable to Licensor pursuant to Section 9.10 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 9.13. Denali shall pay to Licensor the royalty amounts due with respect to a given Calendar Quarter within forty five (45) days after the end of such Calendar Quarter and each such payment once made shall be non-refundable except as expressly provided in Section 9.17. Each payment of royalties due to Licensor shall be accompanied by a statement of the amount of Net Sales of each Licensed Product in each country or other jurisdiction in the Territory during the applicable Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars), the applicable royalty rate(s) under this Agreement (including any reduction(s) to such royalty rate(s) under Section 9.10.2) and a calculation of the amount of royalty payment due on such Net Sales for such Calendar Quarter. |
9.13 |
Mode of Payment. All payments to either Party under this Agreement shall be made from the US to the UK, without setoff, by deposit of Dollars in the requisite amount to such bank account as Licensor may from time to time designate by notice to Denali. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using its, its Affiliates or Sublicensees standard conversion methodology consistent with Accounting Standards. |
9.14 |
Withholding Taxes. When a Party becomes aware that it will have an obligation to deduct or withhold an amount for or on account of tax from any payment under this Agreement it shall notify the Party who is entitled to receive the payment in writing as soon as reasonably practicable and the Parties shall use their reasonable endeavours to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement, treaty or domestic exemption which may apply to eliminate or reduce withholding taxes and otherwise provide the other Party such assistance as is reasonably required to obtain a refund of the withheld or similar taxes, or obtain a credit with respect to such taxes. In the event there is no applicable double taxation agreement, treaty or domestic exemption, or if an applicable double taxation agreement, treaty or domestic exemption reduces but does not eliminate such withholding or similar tax, the payor shall deduct the amount paid from the amount due to the payee, remit such withholding or similar tax to the appropriate tax authority and secure and send to the payee reasonable evidence of the payment of such withholding or similar tax. In the event that any taxes (including without limitation any stamp duties or stamp duty reserve taxes) are required by applicable tax law to be withheld or deducted for or on account of tax from any payments made under this Agreement, any taxes so withheld and deducted from any payment by the payor and paid over to the appropriate government tax authority shall be treated as paid to the payee under this Agreement. |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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9.15 |
Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the Indirect Taxes). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within forty-five (45) days of receipt. |
9.16 |
Financial Records. Denali shall, and shall cause its Sublicensees and Affiliates to, keep complete and accurate books and records pertaining to Net Sales of Licensed Products in sufficient detail to calculate all amounts payable hereunder and to verify compliance with its obligations under this Agreement. Such books and records shall be retained by Denali and its Sublicensees and Affiliates until [***] after the end of the Calendar Year to which such books and records pertain. |
9.17 |
Audit. At the request of Licensor, Denali shall, and shall cause its Sublicensees and Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by Licensor and reasonably acceptable to Denali, at reasonable times during normal business hours and upon reasonable notice, to audit the books and records maintained pursuant to Section 9.16 to ensure the accuracy of all payment reports and payments made hereunder. Such examinations may not (a) be conducted for any Calendar Quarter more than [***] after the end of such Calendar Year to which such books and records pertain, (b) be conducted more than once in any twelve (12) month period (unless a previous audit during such twelve (12)-month period revealed an underpayment with respect to such period) or (c) be repeated for any Calendar Quarter. The accounting firm shall report to the Parties with reasons whether the reports are correct or not, and the specific details concerning any discrepancies. No other information shall be shared with Licensor. Except as provided below, the cost of this audit shall be borne by the auditing Party, unless the audit reveals a variance of more than [***] from the reported amounts, in which case the audited Party shall bear the cost of the audit. Unless disputed pursuant to Section 9.18 below, if such audit concludes that (i) additional amounts were owed by the audited Party, the audited Party shall pay the additional amounts within thirty (30) days, or (ii) excess payments were made by the audited Party, the auditing Party shall reimburse such excess payments, in either case ((i) or (ii)), within sixty (60) days after the date on which such audit is completed by the auditing Party. The accounting firm shall provide to Denali a preliminary copy of its audit report, and shall discuss with Denali any issues or discrepancies that Denali identifies, prior to submission to Licensor. |
9.18 |
Audit Dispute. In the event of a dispute with respect to any audit under Section 9.17, Licensor and Denali shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Partys certified public accountants or to such other Person as the Parties shall mutually agree (the Audit Arbitrator). The decision of the Audit Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Audit Arbitrator shall determine. Not later than thirty (30) days after such decision and in accordance with such decision, the audited Party shall pay the additional amounts, or the auditing Party shall reimburse the excess payments, as applicable. |
9.19 |
Confidentiality. The receiving Party shall treat all information subject to review under this ARTICLE 9 in accordance with the confidentiality provisions of ARTICLE 11 and the Parties shall cause the Audit Arbitrator to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. |
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ARTICLE 10
INTELLECTUAL PROPERTY
10.1 |
Ownership of Intellectual Property. |
10.1.1 |
Licensor Ownership. As between the Parties, (a) Licensor, F-star Ltd or F-star GmbH or an Affiliate of any of them designated by Licensor shall Control all right, title, and interest in and to any and all Licensor Background IP and any and all Platform IP; and (b) Licensor shall solely own all right, title and interest in and to any and all Licensor Program IP. |
10.1.2 |
Denali Ownership. As between the Parties, Denali or an Affiliate designated by Denali shall solely own all right, title, and interest in and to any and all Denali Program IP and Denali Background IP. |
10.1.3 |
Ownership of Technology. |
(a) |
Except as set forth in this Section 10.1.3(a), as between the Parties, each Party shall own all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of such Party (or its Affiliates or sublicensees) under or in connection with this Agreement, whether or not patented or patentable, and any and all Patents and other intellectual property rights with respect thereto, and (b) other Information, inventions, Patents, and other intellectual property rights that are owned or otherwise Controlled (other than pursuant to the license grants set forth in Section 8.1) by such Party, its Affiliates or its licensees or sublicensees. Notwithstanding the foregoing: |
(i) |
as between the Parties, F-star or Licensor shall own all Information or invention or any Patent or intellectual property rights with respect thereto, that is Licensor Background Know-How, Licensor Background Patents, Platform Know-How, Platform Patents, Licensor Program Know-How and Licensor Program Patents; |
(ii) |
as between the Parties Denali shall own Information or inventions or any Patent or intellectual property rights with respect thereto, that is Denali Background Know-How, Denali Background Patents, Denali Program Know-How and Denali Program Patents; and |
(iii) |
as between the Parties the Parties shall own jointly Information or inventions or any Patent or intellectual property rights with respect thereto, that is Joint Program Know-How and Joint Program Patents. |
Confidential
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(b) |
Ownership of Joint Program IP. As between the Parties, the Parties shall each own an equal, undivided interest in any and all Joint Program IP. Within thirty (30) days, each Party shall disclose to the other Party in writing, and shall cause its Affiliates, licensees and sublicensees to so disclose, the development, making, conception or reduction to practice of any Joint Program IP. Subject to the licenses and rights of reference granted under Section 8.1 and, in the case of Licensor, its exclusivity and other obligations hereunder (including Licensors obligations under ARTICLE 6), each Party shall have the right to Exploit the Joint Program IP without a duty of seeking consent or accounting to the other Parties. |
(c) |
United States Law. Inventorship of Information and inventions conceived, discovered, developed, or otherwise made under this Agreement shall be determined in accordance with Applicable Law in the United States as such law exists as of the Effective Date irrespective of where such conception, discovery, development or making occurs. |
(d) |
Disclosure Obligation. Denali shall promptly disclose to Licensor (and Licensor shall be permitted to disclose to F-star Ltd) in writing, the conception, discovery, development or making of any Licensor Program Know-How and Platform Know-How. Licensor shall promptly disclose to Denali in writing, the conception, discovery, development or making of any Denali Program Know-How. |
(e) |
Assignment Obligation. Denali, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), (i) to Licensor all its right, title and interest in and to any Licensor Program Know-How and Licensor Program Patents; and (ii) to F-star Ltd all its right, title and interest in and to any Platform Know-How and Platform Patents. Denali will execute and record assignments and other necessary documents consistent with such ownership. Licensor, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), to Denali all its right, title and interest in and to any Denali Program Know-How and Denali Program Patents. Licensor will execute and record assignments and other necessary documents consistent with such ownership. Each Party shall cause all Persons who perform Development activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such Person to agree to such assignment obligation despite such Partys using commercially reasonable efforts to negotiate such assignment obligation, provide a license under) their rights in any Information and inventions resulting therefrom to such Party, except where Applicable Law requires otherwise and except in the case of governmental, not-for-profit and public institutions which have standard policies against such an assignment (in which case a suitable license, or right to obtain such a license, shall be obtained). |
10.2 |
Maintenance and Prosecution of Patents. |
10.2.1 |
Licensor Patent Prosecution and Maintenance. |
(a) |
Licensor Background Patents. Licensor Background Patents shall be prepared, filed, prosecuted, and maintained by or on behalf of the owner of such Patent. |
Confidential
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(b) |
Platform Patents. Platform Patents shall be prepared, filed, prosecuted, and maintained by or on behalf of F-star Ltd. |
(c) |
Licensor Program Patents. |
(i) |
Save as provided in Section 10.2.1(c)(ii), all Licensor Program Patents shall be prosecuted by Licensor or an Affiliate designated by Licensor at their cost. |
(ii) |
Notwithstanding the provisions of Section 10.2.1(c)(i), any Licensor Program Patents that exclusively claim the specific sequence of an Fcab against an Accepted Fcab Target, or which claims the manufacture or use of such an Fcab (a Selected Fcab Program Patent) shall be prosecuted by Licensor in cooperation with Denali and the costs of such prosecution shall be [***]. Denali shall be invoiced for its share of such costs monthly in arrears and such invoices shall be paid within thirty (30) days in accordance with Sections 9.13 through 9.15. Licensor shall discuss steps with regard to the preparation, filing, prosecution, and maintenance strategy (including timing of filing, data to be included, and scope of claims of patent applications) and keep Denali reasonably informed of any material drafts, filings and correspondence with a Patent Office with respect to Selected Fcab Program Patents and shall reasonably consider any of Denalis comments in respect of the same. Licensor shall promptly inform Denali of any adversarial patent office proceeding, including a request for, or filing or declaration of, any interference, opposition, or reexamination relating to a Selected Fcab Program Patent in the Territory. Licensor shall thereafter consult and cooperate with Denali (and any other Third Party licensees) to determine a course of action with respect to any such proceeding in respect of a Selected Fcab Program Patent in the Territory, and Licensor shall consider in good faith all reasonable comments, requests and suggestions provided by Denali (and any other Third Party licensees) with respect to any such proceeding. If Licensor elects not to file a patent application in any country, or decides to abandon a pending application or issued patent in any country, Licensor shall provide prior written notice sufficiently in advance of any abandonment to enable Denali, and Denali shall have the right at its sole expense to assume control of the preparation, filing, prosecution and maintenance of such patent application or Patent at its own expense and Licensor shall transfer such prosecution to Denali. |
10.2.2 |
Denali Patent Prosecution and Maintenance. Denali shall have the right, but not the obligation, to prepare, file, prosecute, and maintain the Denali Background Patents, the Denali Program Patents and the Joint Program Patents worldwide, at Denalis sole cost and expense. Denali shall keep Licensor reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance strategy (including timing of filing, data to be included, and scope of claims of patent applications) of the Denali Program Patents and the Joint Program Patents and shall discuss steps with regard to the preparation, filing, and strategy (including timing of |
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filing, data to be included, and scope of claims of patent applications) with respect to Denali Program Patents disclosing Joint Fcabs and shall reasonably consider any of Licensors comments in respect of the same. If Denali, during the Term of this Agreement, determines in its sole discretion to abandon or not maintain any of the Joint Program Patents in the Territory, then Denali shall provide Licensor with prior written notice sufficiently in advance of any abandonment to enable Licensor, at Licensors sole discretion, to maintain such Joint Program Patents and assume the prosecution in the joint names of the Parties and on receipt of such notice, Denali shall transfer such prosecution to Licensor. |
10.2.3 |
Patent Term Extension and Supplementary Protection Certificate. |
(a) |
Cooperation. The Parties shall cooperate on decisions regarding patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wherever applicable, for Denali Program Patents, Denali Background Patents, Licensor Program Patents and Joint Program Patents as they relate to a Licensed Product in any country or other jurisdiction. |
(b) |
Denali Patents. Denali shall have the responsibility of applying for any extension or supplementary protection certificate with respect to Denali Program Patents, Denali Background Patents and Joint Program Patents in the Territory. |
(c) |
Selected Fcab Program Patents. If, in a jurisdiction more than one Patent may be extended or be the subject of a supplementary protection certificate, then Licensor shall have the right to apply for any extension or supplementary protection certificate with respect to Selected Fcab Program Patents in the Territory provided however, if, in the relevant jurisdiction (including the US) only one Patent may be extended or be the subject of a supplementary protection certificate, then Denali shall have the sole right and responsibility of applying for any extension or supplementary protection certificate with respect to any Selected Fcab Program Patent that claims or covers the sequence of the Fcab incorporated into the relevant mAb2 in such jurisdiction. In the event that Denali does not seek to extend any Patent (whether a Licensor Program Patent, a Denali Program Patent, a Denali Background Patent or any other Patent) in respect of a mAb2 prior to thirty (30) days before the expiry of the relevant time limits then Licensor shall have the right but not the obligation to seek an extension of any Licensor Background Patent, Licensor Program Patent or Platform Patent in respect of a mAb2 on providing prior written notice to Denali. |
(d) |
Other Licensor Program Patents. Subject to Section 10.2.3(c), Licensor shall have the responsibility of applying for any extension or supplementary protection certificate with respect to Licensor Background Patents, Platform Patents and Licensor Program Patents in the Territory. |
(e) |
Information and Assistance. Each Party shall keep the other fully informed of its efforts to obtain such extension or supplementary protection certificate. Each Party shall provide prompt and reasonable assistance, as requested by the other, including by taking such action as patent holder as is required under any Applicable Law to obtain such patent extension or supplementary protection certificate. The applying Party shall pay all expenses in regard to obtaining the extension or supplementary protection certificate in the Territory. |
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10.2.4 |
CREATE Act. Notwithstanding anything to the contrary in this ARTICLE 10, neither Party shall have the right to make an election under (i) the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the CREATE Act) or (ii) the Leahy-Smith America Invents Act of 2011, 35 U.S.C. 100(h) and 102(c)(1)-(3) (the AIA) when exercising its rights under this ARTICLE 10 without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed. With respect to any such permitted election, the Parties shall coordinate their activities with respect to any submissions, filings, or other activities in support thereof. The Parties acknowledge and agree that this Agreement is a joint research agreement as defined in the CREATE Act and AIA. |
10.2.5 |
Patent Listings. |
(a) |
Denali shall have the sole right to make all filings with Regulatory Authorities in the Territory regarding Licensed Products and with respect to Licensor Program Patents, Denali Program Patents, Denali Background Patents and Joint Program Patents, including as required or allowed (a) in the United States, in the FDAs Orange Book if in the future legislation employs the Orange Book for biologics, or its alternative, and (b) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/83/EC or other international equivalents. Licensor shall (i) provide to Denali all Information, including a correct and complete list of Licensor Program Patents to enable Denali to make such filings with Regulatory Authorities in the Territory with respect to such Patents, and (ii) cooperate with Denalis reasonable requests in connection with Licensor Program Patents, including meeting any submission deadlines, in each case ((i) and (ii)), to the extent required or permitted by Applicable Law. |
(b) |
The Parties will negotiate in good faith regarding filings with Regulatory Authorities in the Territory regarding Licensed Products with respect to Licensor Program Patents, including as required or allowed (i) in the United States, in the FDAs Orange Book if in the future legislation employs the Orange Book for biologics, or its alternative, and (ii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/83/EC or other international equivalents. In the event that the Parties are unable to reach agreement, Denali will have the tie-breaking vote. |
10.3 |
Enforcement of Patents. |
10.3.1 |
Enforcement of Licensor Background Patents. During the Term, Licensor or F-star Ltd shall, as between the Parties, have the sole and exclusive right, but not the obligation, to enforce and defend worldwide under its control, at its own expense, the Licensor Background Patents and Platform Patents. |
10.3.2 |
Enforcement of Licensor Program Patents for Non-Accepted Fab Targets. During the Term, as between the Parties, Licensor shall have the exclusive right, but not the obligation, to enforce and defend worldwide under its control, and at its own expense, the Licensor Program Patents and the Joint Program Patents with respect to infringement by Third Party Antibodies that contain a Fab that does not bind to an Accepted Fab Target (or in the case of a Incorporated |
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Biologic, a Fab that does not incorporate an Accepted Fab Target). Denali shall not have the right to enforce or defend the Licensor Program Patents with respect to infringement by Third Party Antibodies that contain a Fab that is not an Accepted Fab Target. |
10.3.3 |
Enforcement of Licensor Program Patents for Accepted Fab Targets, Denali Program Patents and Joint Program Patents. During the Term, Denali shall have the exclusive right, but not the obligation, to enforce and defend worldwide under its control, and at its own expense (a) the Licensor Program Patents and Joint Program Patents, with respect to infringement by Third Party Antibodies that contain a Fab that binds to an Accepted Fab Target (or in the case of a Incorporated Biologic, a Fab that incorporates or acts on an Accepted Fab Target) and (b) the Denali Program Patents. Licensor shall not have the right to enforce or defend (i) the Licensor Program Patents or Joint Program Patents, with respect to infringement by Third Party Antibodies that contain a Fab that binds to an Accepted Fab Target (or in the case of a Incorporated Biologic, a Fab that incorporates or acts on an Accepted Fab Target), or (ii) the Denali Program Patents. |
10.3.4 |
Patent Exclusivity Listing. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a Biosimilar Application) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA), either Party shall, within ten (10) Business Days, notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If either Party receives any equivalent or similar certification or notice in any other jurisdiction in the Territory, either Party shall, within ten (10) Business Days, notify and provide the other Party with copies of such communication. Regardless of the Party that is the reference product sponsor for purposes of such Biosimilar Application, (a) Denali shall have the sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application; (b) Denali shall have the sole right to list any Licensor Program Patents and Joint Program Patents, insofar as they claim or cover the applicable Licensed Product as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in Section 351(l) of the PHSA; and (c) Denali shall have the sole right to identify Licensor Program Patents or Joint Program Patents or respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. If required pursuant to Applicable Law, Licensor shall prepare such lists and make such responses at Denalis direction. |
10.3.5 |
Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in this Section 10.3, Denali shall have the sole right to bring an action for infringement of the Licensor Program Patents, Denali Background Patents, Denali Program Patents, or Joint Program Patents with respect to mAb2 or Licensed Products as required under Section 351(l)(6) of the PHSA following the agreement on a list of Patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B) of such act, or as required following any equivalent or similar certification or notice in any other |
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jurisdiction. The Parties rights and obligations with respect to the foregoing legal actions shall be as set forth in Sections 10.3.2 through 10.3.3 provided, that within fifteen (15) days of reaching agreement on a list of Patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B), Denali shall notify Licensor as to whether or not it elects to prosecute such infringement. Either Party shall, within ten (10) Business Days, notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction. Thereafter, the Party controlling any Patent infringement litigation pursuant to this Section 10.3.5 shall have the first right to seek an injunction against such commercial marketing as permitted pursuant to Section 351(l)(8)(B) of the PHSA. If no such litigation is ongoing at the time of such notice, then Denali shall have the first right to seek such an injunction. |
10.3.6 |
Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 10.3. Where a Party brings such an action, the other Parties shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Unless otherwise set forth herein, the Party entitled to bring any patent infringement litigation in accordance with this Section 10.3 shall have the right to settle such claim; provided that no Party shall have the right to settle any patent infringement litigation under this Section 10.3 in a manner that diminishes or has a material adverse effect on the rights or interest of the other Party, or in a manner that imposes any costs or liability on, or involves any admission by, the other Party, without the express written consent of such other Party, such consent not to be unreasonably withheld, conditioned or delayed. The Party commencing the litigation shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings. |
10.3.7 |
Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such litigation described in Sections 10.3.2, 10.3.1, 10.3.3, 10.3.5 or 10.3.6 (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any remainder after such reimbursement is made shall be [***]. |
10.4 |
Invalidity or Unenforceability Defenses or Actions. |
10.4.1 |
Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Licensor Background Patents, Licensor Program Patents, or Joint Program Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
10.4.2 |
Licensor Patents. Licensor shall have the sole right, but not the obligation, to defend and control the defense of the validity and enforceability of the Licensor Background Patents, Licensor Program Patents (other than any Selected Fcab Program Patents) and Platform Patents. |
10.4.3 |
Licensor Program Patents. In the event that either Party becomes aware that a Third Party proposes to challenge the validity or enforceability of the Licensor Program Patents then that |
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Party shall inform the other Party and the Parties shall discuss the most appropriate course of action. Licensor shall have the first right to defend such proceedings provided and shall take all reasonable comments, requests and suggestions provided by Denali with respect thereto. In the event that Licensor declines to defend the validity or enforceability of any Selected Fcab Program Patents within any relevant time limit it shall inform Denali sufficiently in advance of any relevant time and Denali shall have the right, but not the obligation, to defend the validity or enforceability of the affected Selected Fcab Program Patents in Licensors name. |
10.4.4 |
Denali Patents and Joint Program Patents. Denali shall have the first right, but not the obligation, to defend and control the defense of the validity and enforceability of the Denali Background Patents, Denali Program Patents and the Joint Program Patents. Licensor may participate in any such claim, suit, or proceeding in the Territory related to the Joint Program Patents, in each case that claim or cover a mAb2 or Licensed Product with counsel of its choice at its own expense; provided that Denali shall retain control of the defense in such claim, suit, or proceeding. If Denali elects not to defend or control the defense of the Joint Program Patents, in each case that claim or cover a mAb2 or Licensed Product in a suit brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, then Licensor may conduct and control the defense of any such claim, suit, or proceeding, at its own expense; provided, that Licensor shall obtain the written consent of Denali prior to settling or compromising such defense, such consent not to be unreasonably withheld, conditioned or delayed. To the extent that there is any claim, suit, or proceeding of any of the Joint Program Patents in the Territory that is not covered by the process set forth above, then each Party shall have the right to defend and control the defense of the validity and enforceability of the Joint Program Patents subject to applicable law. |
10.4.5 |
Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 10.4, including by being joined as a party plaintiff in such action or proceeding, providing access to relevant documents and other evidence, and making its employees available at reasonable business hours. In connection with any such defense or claim or counterclaim related to Section 10.4.3, the controlling party shall keep the other Party reasonably informed of any steps taken, and shall provide copies of all documents filed, in connection with such defense, claim, or counterclaim. In connection with the activities set forth in thisSection 10.4, each Party shall consult with the other as to the strategy for the defense of the Licensor Program Patents and Joint Program Patents, in each case that claim or cover a mAb2 or Licensed Product. |
10.5 |
Inventors Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Partys inventors under any applicable inventor remuneration laws. |
ARTICLE 11
CONFIDENTIALITY AND NON-DISCLOSURE
11.1 |
Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party and F-star GmbH and F-star Ltd shall, and each of the foregoing shall cause its Affiliates and its and their respective officers, directors, employees, consultants, contractors and agents to, keep confidential and not publish or otherwise disclose to a Third |
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Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement, including exercising rights granted hereunder. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 11.1 with respect to any Confidential Information shall not include any information that: |
11.1.1 |
has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party, or by F-star GmbH or F-star Ltd and their Affiliates, to the extent Licensor is the receiving Party; |
11.1.2 |
have been in the receiving Partys (or in the event Licensor is the receiving Party, F-star GmbHs or F-star Ltds) possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
11.1.3 |
is subsequently received by the receiving Party (or in the event Licensor is the receiving Party, subsequently received by F-star GmbH or F-star Ltd,) from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
11.1.4 |
that is generally made available to Third Parties by the disclosing Party (or in the event Licensor is the disclosing Party, by F-star GmbH or F-star Ltd) without restriction on disclosure; or |
11.1.5 |
have been independently developed by or for the receiving Party (or in the event Licensor is the receiving Party, by or for F-star GmbH or F-star Ltd) without reference to, or use or disclosure of, the disclosing Partys Confidential Information. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party (or in the event Licensor is the receiving Party, the possession of F-star GmbH, F-star Ltd or its or their respective Affiliates) merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party (or in the event Licensor is the receiving Party, in the possession of F-star GmbH, F-star Ltd or its or their respective Affiliates). Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination are in the public domain or in the possession of the receiving Party (or in the event Licensor is the receiving Party, in the possession of F-star GmbH, F-star Ltd or its or their respective Affiliates).
11.2 |
Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
11.2.1 |
in the reasonable opinion of the receiving Partys (or in the event Licensor is the receiving Party, the reasonable opinion of F-star GmbHs or F-star Ltds) legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators, but subject to Section 11.4)); provided, that the receiving Party (or in the event Licensor is the receiving Party, F-star GmbH or F-star Ltd) shall first have given prompt written notice (and to the extent |
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possible, at least five (5) Business Days notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information (for example, quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party (or in the event Licensor is the receiving Party, F-star GmbH or F-star Ltd) shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed; |
11.2.2 |
made by or on behalf of the receiving Party (or in the event Licensor is the receiving Party, by or on behalf of F-star GmbH or F-star Ltd) or their licensees or sub-licensees to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with Applicable Law; |
11.2.3 |
subject to written consent of the disclosing Party, made by or on behalf of the receiving Party (or in the event Licensor is the receiving Party, by or on behalf of F-star GmbH or F-star Ltd) to a patent authority as may be reasonably necessary or useful for purposes of obtaining, defending or enforcing a Patent; provided, that reasonable measures shall be taken to assure confidential treatment of such Confidential Information, to the extent such protection is available; |
11.2.4 |
made to its or its Affiliates, (or if to Licensor, to F-star GmbHs or F-star Ltds) financial and legal advisors who have a need to know such disclosing Partys Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, at least as restrictive as those set forth in this Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and legal advisors, to treat such Confidential Information as required under this ARTICLE 11; |
11.2.5 |
made by the receiving Party or its Affiliates (or in the event Licensor is the receiving Party, by F-star GmbH or F-star Ltd or their respective Affiliates) to potential or actual investors, acquirers, investment bankers, lenders, as may be necessary in connection with their evaluation of a potential or actual investment in or acquisition of the receiving Party or its Affiliates (or in the event Licensor is the receiving Party, of F-star GmbH or F-star Ltd or their respective Affiliates); provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 11; |
11.2.6 |
made by Denali or its Affiliates or Sublicensees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in connection with the Exploitation of any mAb2, the Licensed Products, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE |
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11 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five (5) years from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors); or |
11.2.7 |
made by Licensor, F-star GmbH, or F-star Ltd or their Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, and the like as may be necessary in assisting with Licensors, F-star GmbHs or F-star Ltds activities contemplated by this Agreement (including in relation to the exercise of the rights granted by Denali in Section 8.3 or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement); provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of Denali substantially similar to the obligations of confidentiality and non-use of Licensor pursuant to this ARTICLE 11 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five (5) years from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors and the like). |
11.3 |
Use of Name. Except as expressly provided herein, none of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates, shall mention or otherwise use the name, logo, or trademark of Denali or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of Denali in each instance. Except as expressly provided herein, neither Denali nor any of its Affiliates shall mention or otherwise use the name, logo, or trademark of Licensor, F-star GmbH, F-star Ltd or any of their Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of Licensor. The restrictions imposed by this Section 11.3 shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Partys counsel, is required by Applicable Law; provided, that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable (and in no event less than three (3) Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. |
11.4 |
Public Announcements. The Parties have agreed the press release set out as Schedule 11.4, which the Parties will not disclose until August 25, 2016. Other than this press release, neither Licensor nor F-star GmbH, F-star Ltd or their respective Affiliates, on the one hand, and Denali and its Affiliates on the other, shall issue any public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the others prior written consent regarding the timing and content, except for any such disclosure that is, in the opinion of the disclosing entitys counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing entity are listed (or to which an application for listing has been submitted). In the event an entity is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such entity shall submit the proposed disclosure in writing to Denali (if the entity is Licensor, F-star GmbH, or F-star Ltd) or Licensor (if the entity making the disclosure is Denali) as far in advance as reasonably practicable (and in no event less than seven (7) Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. Notwithstanding the foregoing, Denali, its Sublicensees and its and their respective Affiliates shall have the right to publicly disclose research, development and commercial information (including with respect to regulatory matters) regarding mAb2 and Licensed Products; provided, that (a) such disclosure is subject to the provisions of ARTICLE 11 with respect to Licensors Confidential Information and Section 11.6 and (b) Denali shall not use the |
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name of Licensor, F-star GmbH, F-star Ltd or its or their respective Affiliates (or insignia, or any contraction, abbreviation or adaptation thereof) in such disclosure without prior written permission of the applicable entity. |
11.5 |
Publications. The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the Parties activities hereunder including under any Technical Development, Fcab Discovery Plan or mAb2 Development Plan. |
11.5.1 |
Prior to the expiration of the Buy-out Option Period neither Party shall make any publications, presentations or public disclosures related to a Selected Fcab unless agreed in writing by the other Party. |
11.5.2 |
After the expiration of Buy-out Option Period if Denali has not exercised the Buy-out Option, then, for the remainder of the Term and subject to Section 11.5.3(b), Licensor, F-star GmbH and F-star Ltd and its and their respective Affiliates shall have the right to make any publications, presentations or public disclosures of their own data (the Licensor Data) related to a Selected Fcab subject to Denalis prior review (but with no requirement for Denalis prior approval). Denali may not make any publications, presentations or public disclosures of the Licensor Data without Licensors prior written approval. |
11.5.3 |
On a mAb2-by-mAb2 basis, (a) Denali shall have the right to make any publications, presentations or public disclosures related to a mAb2 or the corresponding Licensed Product without the need to seek approval or comment from Licensor or F-star Ltd or F-star GmbH, and (b) neither Licensor, nor F-star GmbH, F-star Ltd or their respective Affiliates may make any publications, presentations or public disclosures related to a mAb2 or the corresponding Licensed Product without Denalis prior written approval. |
11.5.4 |
Before any paper is submitted for publication or an oral presentation is made for which review or approval rights are provided under Section 11.5, the publishing or presenting Party (or F-star Ltd or F-star GmbH or their respective Affiliates, if they are publishing or presenting, collectively, the Publishing Party)) shall deliver a then-current copy of the paper or materials for oral presentation to the non-publishing Party at least thirty (30) days prior to submitting the paper to a publisher or making the presentation where written approval is required and at least fifteen (15) days prior to submitting the paper to a publisher or making the presentation where approval is not required. The non-publishing Party shall review any such paper and give its comments to such Publishing Party within ten (10) days of the delivery of such paper to such other Party. The Publishing Party shall comply with the other Partys request to delete references to the other Partys Confidential Information in any such paper and will withhold publication of any such paper or any presentation of same for an additional sixty (60) days in order to permit the Parties to obtain Patent protection if such other Party deems it necessary. |
11.5.5 |
Notwithstanding anything herein to the contrary, Licensor, F-star GmbH, F-star Ltd, and its and their respective Affiliates shall have the right to make any publications, presentations or public disclosures relating to (a) any Fcabs other than Selected Fcabs, or (b) any Antibody other than to the extent related to a mAb2 or Licensed Product, in each case without any approval, review or comments rights by Denali. |
11.6 |
Return of Confidential Information. Upon the effective date of the termination of this Agreement with respect to any Accepted Fcab Target or Accepted Fab Target for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first Party |
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does not retain rights under the surviving provisions of this Agreement: (a) as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) as soon as reasonably practicable, deliver to the requesting Party, at the other Partys expense, all copies of such Confidential Information in the possession of the other Party; provided, that the other Party shall be permitted to retain one (1) copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder, as required by Applicable Law, or for archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Partys automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Partys standard archiving and back-up procedures, but not for any other use or purpose. |
11.7 |
Licensor Permitted Disclosure. After the expiration of Buy-out Option Period if Denali has not exercised the Buy-out Option, then Licensor will be permitted to disclose to a potential Third Party strategic partner interested in a transaction involving a Selected Fcab (but not pursuant to any press release, public announcement or public disclosure unless expressly agreed by the Parties in writing pursuant to Section 11.4) that Licensor has entered into a strategic partnering relationship granting an undisclosed Third Party the exclusive right to exploit mAb2s containing the Selected Fcab for use with the Accepted Fab Targets and, if applicable, that such Third Party has the right to nominate additional Accepted Fab Targets for use with the Selected Fcab; provided, that (a) such disclosure is subject to the provisions of Sections 11.1, 11.2 and 11.5 with respect to Denali Confidential Information, (b) the Denali name (or any insignia, logo or trademark, or any contraction, abbreviation or adaptation thereof) shall not be mentioned or otherwise used in connection with any such disclosure, and (c) such disclosure shall not otherwise disclose any of the terms of this Agreement. |
ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1 |
Representations and Warranties of Denali. Except as set forth in the Disclosure Schedule, Denali represents and warrants, as of the Effective Date as follows: |
12.1.1 |
Organization. Denali is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
12.1.2 |
Authorization. The execution and delivery of this Agreement and the performance by Denali of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) Denalis charter documents, bylaws, or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which such Denali is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to Denali. |
12.1.3 |
Binding Agreement. This Agreement is a legal, valid, and binding obligation of Denali enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). |
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12.1.4 |
No Inconsistent Obligation. Denali is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder. |
12.1.5 |
There are no written claims, judgments, or settlements against, or amounts with respect thereto, owed by Denali relating to (i) the Denali Background Patents, or (ii) the Denali Background Know-How. To Denalis knowledge, no written claim or litigation has been brought or threatened by any Person alleging that (a) the Denali Background Patents are invalid or unenforceable, or (b) the Denali Background Patents, or the Denali Background Know-How, or the disclosing, copying, making, assigning, or licensing of the Denali Background Patents, or the Denali Background Know-How as contemplated by this Agreement violates, infringes, misappropriates or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party. |
12.1.6 |
To Denalis knowledge, the use of any Denali Background IP disclosed to Licensor for the conduct of the TfR Fcab Discovery Plan will not infringe, misappropriate, misuse, violate or otherwise make use without authorisation of any Third Party intellectual property nor has any person threatened to Denali in writing to issue such a notice. |
12.2 |
Representations and Warranties of Licensor. Licensor represents and warrants to Denali, as of the Effective Date as follows: |
12.2.1 |
Organization. Licensor is a limited liability company duly incorporated and validly existing under the laws of England and Wales. Licensor has all requisite power and authority, corporate or otherwise, to execute, deliver and perform its respective obligations under this Agreement. |
12.2.2 |
Authorization. The execution and delivery of this Agreement and the performance by Licensor of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) Licensors articles of association or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which such Licensor is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to Licensor. |
12.2.3 |
Binding Agreement. This Agreement is the legal, valid and binding obligation of Licensor enforceable in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the enforcement of creditors rights generally and by the effect of general principles of equity (regardless of whether enforcement is considered in a proceeding in equity or at law). |
12.2.4 |
No Inconsistent Obligation. Licensor is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder. |
12.2.5 |
No Claims. Except as disclosed by Licensor to Denali in writing in the letter from Licensor to Denali on the Effective Date, there are no written claims, judgments, or settlements against, or |
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amounts with respect thereto, owed by Licensor, or to Licensors knowledge by F-star GmbH, F-star Ltd or any of their respective Affiliates, relating to (i) the Licensor Background Patents, or (ii) the Licensor Background Know-How. To Licensors knowledge, no written claim or litigation has been brought or threatened by any Person alleging that (a) the Licensor Background Patents are invalid or unenforceable, or (b) the Licensor Background Patents, or the Licensor Background Know-How, or the disclosing, copying, making, assigning, or licensing of the Licensor Background Patents, or the Licensor Background Know-How as contemplated by this Agreement violates, infringes, misappropriates or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party. |
12.2.6 |
No Misappropriation. Except as disclosed by Licensor to Denali in writing in the letter from Licensor to Denali on the Effective Date, to the Knowledge of Licensor no Person is infringing or misappropriating (i) the Licensor Background Patents, or (ii) the Licensor Background Know-How. |
12.2.7 |
Licensor In-Licenses. Licensor has provided Denali with complete and correct copies of all Licensor In-Licenses, and there have been no modifications, amendments or restatements other than as provided to Denali prior to the Effective Date. The Licensor In-Licenses are in full force and effect in accordance with their terms. After giving effect to this Agreement, there exist no breaches, defaults or events which would (with the giving of notice, the passage of time or both) give rise to a breach, default or other right to terminate or modify any Licensor In-License. Licensor has not transferred or granted, and Licensor shall not transfer or grant, to any Third Party any license or other interest in the Licensor In-Licenses. |
12.3 |
DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NONE OF LICENSOR, F-STAR LTD, F-STAR GMBH OR DENALI OR ANY OF THEIR RESPECTIVE AFFILIATES MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. |
12.4 |
Covenants. |
12.4.1 |
During the Term, Licensor shall not encumber or adversely affect the rights granted to Denali hereunder with respect to the Licensor Background IP or Licensor Program IP insofar as they relate to the Exploitation of mAb2 and Licensed Products, including in each case by (a) committing any acts or permitting the occurrence of any omission that would cause the material breach or termination of the Gamma IP License or (b) amending or otherwise modifying or permitting to be modified or amended the Gamma IP License in a manner that would adversely affect any rights of Denali under this Agreement. |
12.4.2 |
During the Term, all contracts entered into between Licensor or its Affiliates, on the one hand, and F-star GmbH or F-star Ltd or any of their respective Affiliates, on the other hand, shall be in writing and shall be on arms length terms. |
12.4.3 |
Denali acknowledges that it has filed provisional patent applications [***]. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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ARTICLE 13
INDEMNITY
13.1 |
Indemnification of Licensor. Denali shall indemnify Licensor, its Affiliates and their respective directors, officers, employees, and agents (the Licensor Indemnitees) and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (including reasonable attorneys fees and expenses) (collectively, Losses) in connection with any and all suits, investigations, claims, or demands of Third Parties (collectively, Third Party Claims) incurred by or rendered against the Licensor Indemnitees arising from or occurring as a result of: |
(a) |
the Exploitation of mAb2 or Licensed Products by or for Denali or any of its Affiliates, Sublicensees, subcontractors, agents and consultants, on a mAb2-by-mAb2 basis after Fcab Delivery or a Denali Fcab Notice and during the Term thereafter; |
(b) |
Denalis (or its Affiliates or Sublicensees) use or practice of the Joint Program IP; |
(c) |
the breach by Denali or its Affiliates of this Agreement; or |
(d) |
the gross negligence or willful misconduct on the part of Denali or its Affiliates or their respective directors, officers, employees, and agents in performing its or their obligations under this Agreement; or |
(e) |
on an Accepted Fcab Target-by-Accepted Fcab Target basis, the infringement by Licensor of any Third Party Patents or Know-How relating to the Accepted Fcab Target, solely to the extent (i) such infringement arose from Licensors conduct of the applicable Fcab Discovery Plan (and not any subsequent research, development or commercialization of a Fcab to such Accepted Fcab Target by Licensor or any product incorporating any such Fcab), and (ii) Denali knew of such Third Party Patents or Know-How at the time of preparing the applicable Fcab Discovery Plan. |
except for those Losses for which Licensor, in whole or in part, has an obligation to indemnify Denali pursuant to Section 13.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses.
13.2 |
Indemnification of Denali. Licensor shall indemnify Denali, its Affiliates and its and their respective directors, officers, employees, and agents (the Denali Indemnitees), and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims incurred by or rendered against the Denali Indemnitees arising from or occurring as a result of: |
(a) |
the Exploitation of Selected Fcabs, by or for Licensor or any of its Affiliates, sublicensees, subcontractors, agents and consultants, pursuant; |
(b) |
Licensors (or its Affiliates or Sublicensees) use or practice of any Licensor Background IP, Licensor Program IP or Joint Program IP; |
(c) |
the breach by Licensor or its Affiliates of this Agreement; or |
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(d) |
the gross negligence or willful misconduct on the part of Licensor or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
except for those Losses for which Denali has an obligation to indemnify Licensor pursuant to Section 13.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
13.3 |
Notice of Claim. All indemnification claims in respect of a Party, F-star Ltd, F-star GmbH, and its and their respective Affiliates, or their respective directors, officers, employees and agents shall be made solely by such Party to this Agreement (the Indemnified Party). The Indemnified Party shall give the indemnifying Party prompt written notice (an Indemnification Claim Notice) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under this ARTICLE 13, but in no event shall the indemnifying Party be liable for any Losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims. |
13.4 |
Control of Defense. |
13.4.1 |
In General. Subject to the provisions of Section 10.4, at its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within thirty (30) days after the indemnifying Partys receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the indemnifying Party shall not be construed as an acknowledgment that the indemnifying Party is liable to indemnify the Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the indemnifying Party of any defenses it may assert against the Indemnified Partys claim for indemnification. Upon assuming the defense of a Third Party Claim, the indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the indemnifying Party which shall be reasonably acceptable to the Indemnified Party. In the event the indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall immediately deliver to the indemnifying Party all original notices and documents (including court papers) received by the Indemnified Party in connection with the Third Party Claim. Should the indemnifying Party assume the defense of a Third Party Claim, except as provided in Section 13.4.2, the indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party Claim unless specifically requested in writing by the indemnifying Party. In the event that it is ultimately determined that the indemnifying Party is not obligated to indemnify, defend or hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party for any Losses incurred by the indemnifying Party in its defense of the Third Party Claim. |
13.4.2 |
Right to Participate in Defense. Without limiting Section 13.4.1, any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, that such employment shall be at the Indemnified Partys own expense unless (a) the employment thereof, and the assumption by the indemnifying Party of such expense, has been specifically authorized by the indemnifying Party in writing, (b) the indemnifying Party has failed |
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to assume the defense and employ counsel in accordance with Section 13.4.1 (in which case the Indemnified Party shall control the defense), or (c) the interests of the Indemnified Party and the indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law, ethical rules or equitable principles. |
13.4.3 |
Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the Indemnified Partys becoming subject to injunctive or other relief or otherwise adversely affecting the business of the Indemnified Party in any manner, and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the indemnifying Party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 13.4.1, the indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss; provided, that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). If the indemnifying Party does not assume and conduct the defense of a Third Party Claim as provided above, the Indemnified Party may defend against such Third Party Claim. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, no Indemnified Party shall admit any liability with respect to, or settle, compromise or dispose of, any Third Party Claim without the prior written consent of the indemnifying Party, which consent shall not to be unreasonably withheld, conditioned or delayed. The indemnifying Party shall not be liable for any settlement, compromise or other disposition of a Loss by an Indemnified Party that is reached without the written consent of the indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed. |
13.4.4 |
Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making Indemnified Parties and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the indemnifying Party shall reimburse the Indemnified Party for all its reasonable out-of-pocket expenses in connection therewith. |
13.4.5 |
Expenses. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis in arrears by the indemnifying Party, without prejudice to the indemnifying Partys right to contest the Indemnified Partys right to indemnification and subject to refund in the event the indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party. |
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13.4.6 |
Special, Indirect, and Other Losses. EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 13, NEITHER PARTY NOR F-STAR LTD, F-STAR GMBH NOR ANY OF THEIR AFFILIATES SHALL BE LIABLE FOR ANY LOSS OF PROFITS OR BUSINESS INTERRUPTION OR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE IN CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THE USE OF THE LICENSED COMPOUND OR LICENSED PRODUCT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. |
13.4.7 |
Insurance. Each Party shall obtain and carry in full force and effect the minimum insurance requirements set forth herein. The types of insurance, and minimum limits shall be: General Liability Insurance with a minimum limit of One Million Dollars ($1,000,000) per occurrence and Two Million Dollars ($2,000,000) in the aggregate. General Liability Insurance shall include, at a minimum, beginning at least thirty (30) days prior to First Commercial Sale of a Licensed Product, product liability insurance. |
13.4.8 |
Certificates of Insurance. Upon request by a Party, the other Party shall provide Certificates of Insurance evidencing compliance with this Section. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain such insurance after the expiration or termination of this Agreement for the longer of (a) a period of five (5) years following termination or expiration of this Agreement in its entirety, or (b) with respect to a particular Party, last sale of a Licensed Product (or but for expiration or termination, would be considered a Licensed Product) sold under this Agreement by a Party. |
ARTICLE 14
TERM AND TERMINATION
14.1 |
Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until the earlier of the date on which Denali has no further milestone or royalty obligations to Licensor hereunder. |
14.2 |
Expiration for Accepted Fab Targets. This Agreement shall expire on an Accepted Fab Target-by-Accepted Fab Target basis on the expiration of the applicable License Option Term for such Accepted Fab Target if Denali has not exercised the License Option for such Accepted Fab Target. |
14.3 |
Effect of Expiration of the Term. Following the expiration of the Term pursuant to Section 14.1, the grants in Section 8.1.4, shall become exclusive, fully-paid, royalty-free and irrevocable. Following expiration of the Term pursuant to Section 14.2, all Licenses and other rights granted to Denali in respect of such Accepted Fab Target shall expire. |
14.4 |
Termination for Material Breach. If either Party (the Non-Breaching Party) believes that the other Party (the Breaching Party) has materially breached one (1) or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a Default Notice). If the Breaching Party fails to cure such breach within [***] days after receipt of the Default Notice the Non-Breaching Party may terminate this Agreement to the extent that it relates to the Accepted Fcab Target or the Accepted Fab Target to which the breach relates, upon written notice to the Breaching Party. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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14.5 |
Termination for For Convenience. Denali may terminate this Agreement in its entirety, or on an Accepted Fcab Target-by-Accepted Fcab Target basis or on an Accepted Fab Target-by-Accepted Fab Target basis, for any or no reason, upon ninety (90) days prior written notice to Licensor. If, upon expiration of the Technical Development Term for an Accepted Fcab Target, (a) Licensor has not achieved the Fcab Delivery for such Accepted Fcab Target, and (b) Denali has not provided a Denali Fcab Notice and (c) Denali has not selected a Licensor Fcab or Joint Fcab for the development of mAb2, then Denali shall provide notice to Licensor of termination of this Agreement with respect to such Accepted Fcab Target. Upon delivery of a notice with respect to an Accepted Fcab Target or an Accepted Fab Target (1) the provisions of ARTICLE 6 (other than with respect to Section 6.4, which shall continue to survive) shall cease to apply to that Accepted Fcab Target or Accepted Fab Target (as the case may be), (2) the applicable exclusivity fee under Sections 9.4 or 9.5 shall terminate and not continue to accrue during such ninety (90) day period, and (3) with respect to termination of an Accepted Fcab Target, Denalis obligation to fund the costs of the applicable Fcab Discovery Plan under Section 9.2 shall terminate. |
14.6 |
Termination by Licensor for Patent Challenge. Licensor will have the right to terminate this Agreement in full upon written notice to Denali in the event that Denali or any of its Affiliates or Sublicensees directly assert in its own respective name or directs a Third Party to assert a Patent Challenge; provided that with respect to any such Patent Challenge by any non-Affiliate Sublicensee, Licensor will not have the right to terminate this Agreement under this Section 14.6 if, within [***] days of Licensors notice to Denali under this Section 14.6, Denali (a) causes such Patent Challenge to be terminated or dismissed or (b) terminates the sublicense granted to such non-Affiliate Sublicensee. For purposes hereof, Patent Challenge means any challenge in a legal or administrative proceeding to the patentability, validity, ownership or enforceability of any of the Licensor Background Patents, Licensor Program Patents or Joint Program Patents (or any claim thereof), including by: (i) filing or pursuing a declaratory judgment action in which any of the Licensor Background Patents, Licensor Program Patents or Joint Program Patents is alleged to be invalid or unenforceable; (ii) citing prior art against any of the Licensor Background Patents, Licensor Program Patents or Joint Program Patents (other than art required to be cited by Applicable Law, including under a duty of candor to a patent office), filing a request for or pursuing a re-examination of any of the Licensor Background Patents, Licensor Program Patents or Joint Program Patents (other than with Licensors written agreement), or becoming a party to or pursuing an interference; or (iii) filing or pursuing any opposition, cancellation, nullity or other like proceedings against any of the Licensor Background Patents, Licensor Program Patents or Joint Program Patents; but excluding any challenge raised as a defense or counterclaim against a claim, action or proceeding asserted by Licensor, F-star Ltd, F-star GmbH or their Affiliates against Denali or its Affiliates or Sublicensees. |
14.7 |
Termination for Insolvency. In the event that either Party (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [***] days after such filing, (d) proposes a written agreement of composition or extension of its debts, (e) proposes or is a party to any dissolution or liquidation, (f) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [***] days of the filing thereof, or (g) admits in writing its inability generally to meet its obligations as they fall due in the general course, then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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14.8 |
Rights in Bankruptcy. |
14.8.1 |
Applicability of 11 U.S.C. § 365(n). All rights and licenses (collectively, the Intellectual Property) granted under or pursuant to this Agreement, including all rights and licenses to use improvements or enhancements developed during the Term, are intended to be, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the Bankruptcy Code) or any analogous provisions in any other country or jurisdiction, licenses of rights to intellectual property as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that the licensee of such Intellectual Property under this Agreement shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, including Section 365(n) of the Bankruptcy Code, or any analogous provisions in any other country or jurisdiction. All of the rights granted to either Party under this Agreement shall be deemed to exist immediately before the occurrence of any bankruptcy case in which the other Party is the debtor. |
14.8.2 |
Rights of Non-Debtor Party in Bankruptcy. If a bankruptcy proceeding is commenced by or against either Party under the Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the non-debtor Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any Intellectual Property and all embodiments of such Intellectual Property, which, if not already in the non-debtor Partys possession, shall be delivered to the non-debtor Party within five (5) Business Days of such request; provided, that the debtor Party is excused from its obligation to deliver the Intellectual Property to the extent the debtor Party continues to perform all of its obligations under this Agreement and the Agreement has not been rejected pursuant to the Bankruptcy Code or any analogous provision in any other country or jurisdiction. |
14.9 |
Effects of Termination by Denali without cause or by Licensor with cause. In the event of termination of this Agreement in its entirety or on an Accepted Fcab Target-by-Accepted Fcab Target basis, or an Accepted Fab Target-by-Accepted Fab Target basis by Denali pursuant to Section 14.5 or by Licensor pursuant to Section 14.4 Section 14.6 or Section 14.7, the following terms and conditions will apply, provided, however, that if the termination relates only to a particular Accepted Fcab Target basis, or Accepted Fab Target (a Terminated Target), then the following provisions will only apply with respect to such Terminated Target: |
(a) |
Except as may otherwise be agreed in writing by the Parties Denali will be responsible at its own expense for an orderly wind-down, in accordance with accepted pharmaceutical industry norms and ethical practices, of any then on-going Clinical Studies of any mAb2 or Licensed Products with respect to a Terminated Target for which it has responsibility; |
(b) |
All rights and licenses granted by Licensor relating to the Terminated Target and any corresponding mAb2 or Licensed Products hereunder shall immediately terminate. Except as expressly set forth in this ARTICLE 14, (i) Denali and its Affiliates and Sublicensees will have no further rights to use any Licensor Background IP, Licensor Program IP or Joint Program IP to |
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Exploit any mAb2 or Licensed Products for which this Agreement has been terminated; (ii) with respect to any mAb2 or Licensed Product that was the subject of a termination of this Agreement, Denali shall continue to pay any milestone payments that may accrue under Sections 9.8 or 9.9 with respect to such mAb2 or Licensed Product and will pay any royalty that may accrue under Section 9.10 with respect to such mAb2 or Licensed Product until expiration of the Royalty Term. |
(c) |
Where the termination has been by Licensor pursuant to Section 14.4 then Denali shall not be entitled to nominate an Accepted Fcab Target and/or Accepted Fab Target to replace the relevant Terminated Targets that were the subject of the termination and in the event that any Terminated Target is an Accepted Fcab Target then the number of Accepted Fab Targets for each Accepted Fcab Target that may be selected by Denali pursuant to Section 3.2 shall be reduced by the number of Accepted Fab Targets that are Terminated Targets; |
(d) |
The obligations under ARTICLE 6 shall immediately terminate with respect to the relevant Terminated Target and any mAb2 or Licensed Products for which this Agreement has been terminated; |
(e) |
All rights and licenses granted by Denali relating to the mAb2 or Licensed Products with respect to a Terminated Target under Section 8.3.1 shall immediately terminate; provided, notwithstanding anything herein to the contrary, that all rights and licenses granted or to be granted by Denali pursuant to Section 8.3.2 or this Section 14.9 shall survive in full force and effect; |
(f) |
Except as set forth in ARTICLE 11, each Party shall return or cause to be returned to the other Party all Confidential Information and all substances or compositions of the other Party or its Affiliates delivered or provided by or on behalf of such other Party, as well as any other material provided by or on behalf of such other Party in any medium, in connection with such Terminated Target; |
(g) |
Denali (for itself and its Affiliates) shall grant to Licensor (without any further action required on the part of Denali): |
(i) |
a non-exclusive [***], irrevocable and perpetual license, with the right to grant sublicenses [***] (subject to Section 8.4, mutatis mutandis), under Denali Program Know-How solely to the extent disclosed in writing to Licensor during the Term and [***] to Exploit, and for the sole purpose of Exploiting, any mAb2 which does not contain a Denali Proprietary Fab or a Denali Fcab (an Available mAb2) for the Terminated Target in the Field in the Territory where a Denali Proprietary Fab is a Fab where the [***] which is, at the relevant time, the Confidential Information of Denali. |
(ii) |
an non-exclusive, [***] irrevocable and perpetual license, with the right to grant sublicenses [***] (subject to Section 8.4, mutatis mutandis), under Denali Program Patents in the Field in the Territory solely to the extent (A) any claims of such Denali Program Patents claim or cover [***], and |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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(B) such claims are [***] to Exploit, and for the sole purpose of Exploiting, any Available mAb2 for the Terminated Target, in the Field in the Territory; and |
(iii) |
a non-exclusive, [***] irrevocable and perpetual license, with the right to grant sublicenses [***] (subject to Section 8.4, mutatis mutandis), under Denalis interest in Joint Program IP solely to the extent [***] to Exploit, and for the sole purpose of Exploiting, any Available mAb2 for the Terminated Target, in the Field in the Territory. |
Notwithstanding the foregoing, in the case Denali terminates this Agreement pursuant to Section 14.5 after Denali has exercised the Buy-out Option and acquired Licensor, Sections 14.9(a), 14.9(b), 14.9(f) and 14.9(g) shall not apply.
14.10 |
Effects of Termination by Denali with cause. In the event of a termination of this Agreement in its entirety or on an Accepted Fcab Target-by-Accepted Fcab Target or Accepted Fab Target-by-Accepted Fab Target basis by Denali pursuant to Section 14.4, or Section 14.7, the following terms and conditions will apply, provided, however, that if the termination relates only to a Terminated Target, then the following provisions will only apply with respect to such Terminated Target: |
(a) |
All rights and licenses granted by Licensor relating to the mAb2 or Licensed Products with respect to a Terminated Target hereunder shall immediately terminate. Except as expressly set forth in this ARTICLE 14, Denali and its Affiliates and Sublicensees will have no further rights to use any Licensor Background IP, Licensor Program IP or Joint Program IP to Exploit any mAb2 or Licensed Products for which this Agreement has been terminated; |
(b) |
The obligations under ARTICLE 6 shall immediately terminate with respect to the Terminated Target and the corresponding mAb2 or Licensed Products for which this Agreement has been terminated; and |
(c) |
All rights and licenses granted by Denali relating to the mAb2 or Licensed Products with respect to a Terminated Target under Section 8.3.1 shall immediately terminate; provided, notwithstanding anything herein to the contrary, that all rights and licenses granted or to be granted by Denali for other Terminated Targets pursuant to Section 8.3.2 or this Section 14.10 shall survive in full force and effect. |
14.11 |
Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
14.12 |
Accrued Rights; Surviving Obligations. |
14.12.1 |
Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration, including any amounts due under ARTICLE 9. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, the following Sections shall survive such termination or expiration 4.12, 6.4, 8.3.2, 8.4, 8.5, 9.13 through 9.19, 10.1, 10.2.4, 12.3, 14.3, 14.9, 14.10, 14.11, 14.12, 15.4 through 15.14 and ARTICLE 11 and ARTICLE 13. |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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14.12.2 |
Notwithstanding the termination of Denalis licenses and other rights under this Agreement, Denali shall have the right for one (1) year after the effective date of such termination to sell or otherwise dispose of all mAb2 or Licensed Product then in its inventory, as though this Agreement had not terminated, and such sale or disposition shall not constitute infringement of Licensors or its Affiliates Patent or other intellectual property or other proprietary rights. For purposes of clarity, Denali shall continue to make payments thereon as provided in ARTICLE 9 (as if this Agreement had not terminated). |
ARTICLE 15
MISCELLANEOUS
15.1 |
Force Majeure. Neither Party (which for the purposes of this Section 15.1 shall include F-star Ltd and F-star GmbH) shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts, or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within [***] days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. |
15.2 |
Potential Competition Review. |
15.2.1 |
If the act of exercise of any License Option requires the making of filings under the Hart-Scott-Rodino Antitrust Improvements Act (the HSR Act), or under any similar pre-merger or antitrust notification provision in the European Union or any other jurisdiction, or if Denalis election not to exercise a License Option results in Licensor being required to make any filings under the HSR Act or under any similar pre-merger or antitrust notification provision in the European Union or any other jurisdiction, then all rights and obligations related to Denali exercising any License Option or Denalis decision not to proceed with the exercise of a License Option will be tolled until the applicable waiting period has expired or been terminated or until approval or clearance from the reviewing authority has been received, and each Party agrees to diligently make any such filings and respond to any request for information to expedite review of such transaction and minimize or avoid any delays in payments. |
15.2.2 |
If the antitrust enforcement authorities in the U.S. make a second request under the HSR Act, or any antitrust enforcement authority in another jurisdiction commences an investigation related to |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Denali exercising a License Option or a decision by Denali not to exercise a License Option, then the Parties will, in good faith, cooperate with each other and take reasonable actions to attempt to (a) resolve all enforcement agency concerns about the transaction under investigation, and (b) diligently oppose any enforcement agency opposition to such transaction. If the enforcement agency files a formal action to oppose the transaction, the Parties will confer in good faith to determine the appropriate strategy for resolving the enforcement agency opposition, including, and where appropriate, the renegotiation of their obligations under this Agreement with respect to the exercise of any License Option, with the objective of placing each Party, to the maximum extent possible, in the same economic position that each Party would have occupied if Denalis decision to proceed with exercise of the License Option or not to proceed with exercise of the License Option had been permitted. Notwithstanding the foregoing, nothing in this Section 15.2 will require either Party to divest, sell, license or otherwise dispose of any assets, entities or facilities. |
15.3 |
Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law. |
15.4 |
Assignment. |
15.4.1 |
Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, no Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided, that a Party may make such an assignment without the other Partys consent to (a) [***], or (b) in the case of Licensor, to [***], or (c) to [***]. With respect to an assignment to [***], or in the case of Licensor, to [***], the assigning Party shall remain responsible for the performance by [***] of the rights and obligations hereunder. Any attempted assignment or delegation in violation of this Section 15.4 shall be void and of no effect. All validly assigned and delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of Licensor or Denali, as the case may be. The permitted assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement. Without limiting the foregoing, the grant of rights set forth in this Agreement shall be binding upon any successor or permitted assignee of Licensor, and the obligations of Denali, including the payment obligations, shall run in favor of any such successor or permitted assignee of Licensors benefits under this Agreement. |
15.4.2 |
Notwithstanding anything to the contrary herein, in the event of the acquisition of a controlling (as such term is used in the definition of Affiliate) interest in Licensor, F-star Ltd, F-star GmbH or Denali the acquirer of such Person shall not be considered to be an Affiliate of such Person for the purposes of this Agreement including for the purposes of the definition Control in respect of the intellectual property of the Parties and |
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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ARTICLE 6. For clarity, any Know-How, Patents or other intellectual property rights or other assets owned or Controlled by an acquirer or its Affiliates before such an acquisition of such Person or which were subsequently generated by the acquirer, or an Affiliate of the acquirer which is not Licensor or an Affiliate of Licensor immediately prior to the acquisition, will not be Controlled by such Person after such Change in Control for purposes of this Agreement or subject to ARTICLE 6, except to the extent that Licensor, F-star GmbH, F-star Ltd or any of their respective Affiliates owned or Controlled such Know-How, Patents or other intellectual property rights or other assets before such acquisition. |
15.5 |
Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect. |
15.6 |
Governing Law, Jurisdiction and Service. |
15.6.1 |
Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction; provided, that all questions concerning (a) inventorship of Patents under this Agreement shall be determined in accordance with Section 10.1.3(b) and (b) the construction or effect of Patents shall be determined in accordance with the laws of the country or other jurisdiction in which the particular Patent has been filed or granted, as the case may be. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods. |
15.6.2 |
Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 15.8.2 shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
15.7 |
Dispute Resolution. Except for disputes resolved by the procedures set forth in Sections 2.8 and 9.18, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute), it shall be resolved pursuant to this Section 15.7. |
15.7.1 |
General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within thirty (30) days (or such other period of time as mutually agreed by the Senior Officers) after such issue was first referred to them, then, except as otherwise set forth in Section 15.7.2, either Party may, by written notice to the other Party, elect to initiate arbitration proceedings pursuant to the procedures set forth in Section 15.7.3 for purposes of having the matter settled. |
Confidential
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15.7.2 |
Intellectual Property Disputes. In the event that a Dispute arises with respect the validity, scope, enforceability, inventorship or ownership of any Patent, trademark or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 15.7.1, and except with respect to determination of inventorship for a Joint Fcab in accordance with Section 1.78, unless otherwise agreed by the Parties in writing, such Dispute shall not be submitted to arbitration in accordance with Section 15.7.3 and instead, either Party may initiate litigation in a court of competent jurisdiction, notwithstanding Section 15.6, in any country or other jurisdiction in which such rights apply. |
15.7.3 |
Arbitration. Should the informal resolution mechanism of Section 15.7.1 prove unsuccessful within the allotted period, then the Parties shall submit their dispute to binding arbitration [***]. Each Party shall appoint one arbitrator who at their turn shall nominate the chairperson, who shall be qualified in [***]. If a Party does not appoint its arbitrator within fifteen (15) days following the expiry of the allotted period, then such arbitrator shall be selected in accordance with the then current rules of [***]. Any arbitrator so selected shall have substantial experience in the pharmaceutical industry. The arbitration shall be conducted, and all documents submitted to the arbitrators shall be, in English. The arbitrators shall have the power to include an award of attorneys fees and costs to the prevailing Party, but shall have no power to award punitive, special, incidental or consequential damages. The arbitrators decision and award shall be final and binding upon all Parties. Subject to any award that the arbitrators may make, each Party shall bear its own costs for its counsel and other expenses, and the Parties shall equally share the costs of the arbitration. Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction. |
15.7.4 |
Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 15.7 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute following the ADR procedures set forth in Section 15.7.3, if necessary to protect the interests of such Party. This Section shall be specifically enforceable. |
15.8 |
Notices. |
15.8.1 |
Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand or (b) sent by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 15.8.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 15.8.1. Such notice shall be deemed to have been given as of the date delivered by hand or on the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 15.8.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. |
15.8.2 |
Address for Notice. |
If to Denali, to:
201 Gateway Boulevard
South San Francisco,
CA 94080
Attention:
Confidential
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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If to Licensor, F-star GmbH or F-star Ltd to:
F-star Gamma Ltd.
Eddeva B920 Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Chief Business Officer and cc: Head of IP
with a copy (which shall not constitute notice) to:
Cooley LLP
Dashwood
69 Old Broad Street
London EC2M 1QS
Attention: John Wilkinson
15.9 |
Entire Agreement; Amendments. This Agreement, together with the Gamma IP License Agreement and the Gamma Support Services Agreement and Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby (including that certain Confidential Disclosure Agreement between Denali Therapeutics Inc. and F-star Ltd dated December 18, 2015; provided that (a) all Confidential Information disclosed or received thereunder will be deemed Confidential Information hereunder and will be subject to the terms and conditions of this Agreement, and (b) all rights and obligations under such agreement will otherwise continue in full force and effect as provided therein). Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. |
15.10 |
English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. |
15.11 |
Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein. |
15.12 |
No Benefit to Third Parties. Except as provided in ARTICLE 13, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. |
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15.13 |
Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement. |
15.14 |
Relationship of the Parties. It is expressly agreed that Licensor, on the one hand, and Denali, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for tax purposes. Neither Licensor, on the one hand, nor Denali, on the other hand, shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party. |
15.15 |
Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by facsimile or electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures. |
[SIGNATURE PAGES FOLLOW.]
Confidential
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THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
DENALI THERAPEUTICS INC | ||
By: |
/s/ Ryan Watts |
|
Name: | Ryan Watts | |
Title: | CEO | |
F-STAR GAMMA LIMITED | ||
By: |
/s/ Tolga Hassan |
|
Name: | Tolga Hassan | |
Title: | CEO + Co. Sec. |
THIS AGREEMENT IS ACKNOWLEDGED AND AGREED by the authorized representatives of F-star Ltd and F-star GmbH as of the Effective Date for the purposes of the following Sections: 3.1.2, 3.1.3, 3.3, 4.1, 4.8, 4.10, 4.12, 8.2, 8.3.3, 8.4.3, 8.5, 8.8, 8.12, 9.2, 9.13, 9.14, 9.15, 9.16, 10.1.1, 10.1.3, 10.2, 10.3, 12.4.2, 13.1, 13.3, 13.4.1 through 13.4.6, 15.1, 15.4.2, 15.5, 15.6, 15.7, 15.8, 15.9, ARTICLE 6 and ARTICLE 11.
F-STAR BIOTECHNOLOGY LIMITED |
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS- UND ENTWICKLUNGSGES.M.B.H |
|||||||
By: |
/s/ Jane Dancer |
By: |
/s/ John Haurum |
|||||
Name: | Jane Dancer | Name: | John Haurum | |||||
Title: | CBO | Title: | CEO |
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Schedule 1.16
Buy-out Option Agreement
SPECIFIC TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH THREE ASTERISKS [***].
DATED 24 AUGUST 2016
DENALI THERAPEUTICS INC. (1)
F-STAR GAMMA LIMITED (2)
THE SHAREHOLDERS (3)
and
SHAREHOLDER REPRESENTATIVE SERVICES LLC (4)
OPTION AGREEMENT
relating to the entire issued share capital of
F-STAR GAMMA LIMITED
COOLEY (UK) LLP, DASHWOOD, 69 OLD BROAD STREET, LONDON EC2M 1QS, UK
T: +44 (0) 20 7583 4055 F: +44 (0) 20 7785 9355 WWW.COOLEY.COM
Confidential
CONTENTS
CLAUSE | PAGE | |||||
1. |
INTERPRETATION |
75 | ||||
2. |
GRANT OF OPTIONS |
78 | ||||
3. |
BUY-OUT OPTION PERIOD |
79 | ||||
4. |
DISCLOSURE |
79 | ||||
5. |
EXERCISE |
80 | ||||
6. |
ACTIONS FOLLOWING EXERCISE |
81 | ||||
7. |
COMPETITION REVIEW |
81 | ||||
8. |
FAILURE TO SELL |
82 | ||||
9. |
REORGANISATION |
82 | ||||
10. |
DETERMINATION BY AN EXPERT |
83 | ||||
11. |
WARRANTIES |
83 | ||||
12. |
OPTIONEE PROTECTIONS |
84 | ||||
13. |
THIRD PARTY OFFERS |
87 | ||||
14. |
CONFIDENTIALITY |
88 | ||||
15. |
SHAREHOLDERS REPRESENTATIVE |
89 | ||||
16. |
FURTHER ASSURANCE |
89 | ||||
17. |
ASSIGNMENT |
89 | ||||
18. |
TERMINATION |
89 | ||||
19. |
ENTIRE AGREEMENT |
89 | ||||
20. |
VARIATION AND WAIVER |
89 | ||||
21. |
COSTS |
90 | ||||
22. |
NOTICES |
90 | ||||
23. |
SEVERANCE |
91 | ||||
24. |
THIRD PARTY RIGHTS |
91 | ||||
25. |
COUNTERPARTS |
91 | ||||
26. |
GOVERNING LAW |
92 | ||||
27. |
DISPUTE RESOLUTION |
92 | ||||
28. |
PROCESS AGENTS |
92 |
Confidential
THIS OPTION AGREEMENT is executed and delivered as a DEED on 24 August 2016
BETWEEN:
(1) |
DENALI THERAPEUTICS INC., a corporation organised and existing under the laws of the State of Delaware, United States, having its principal place of business at 201 Gateway Boulevard, South San Francisco, California, United States (the Optionee); |
(2) |
F-STAR GAMMA LIMITED, a private limited company incorporated under the laws of England and Wales under company number 10214672, having its registered office at Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT (the Company); |
(3) |
THE PERSONS, whose names and addresses are set out in Part 1 of Schedule 1 (the Shareholders); and |
(4) |
SHAREHOLDER REPRESENTATIVE SERVICES LLC, a Colorado limited liability company and which is a party to this Agreement solely in its capacity as representative of the Shareholders (the Shareholders Representative), |
(each of the Optionee, the Company and the Shareholders a Party and together, the Parties).
WHEREAS:
(A) |
The Shareholders are the legal and beneficial owners of the Option Shares as set out beside their respective names at Part 2 of Schedule 1. |
(B) |
The Shareholders have agreed to grant a call option in respect of the Option Shares in favour of the Optionee on the terms and subject to the conditions of this Agreement and the Parties have agreed that the Optionee shall, upon exercise of the call option granted pursuant to this Agreement, purchase the Option Shares in accordance with the terms of the share purchase agreement attached at Schedule 2 (the SPA). |
(C) |
Concurrently with the execution and delivery of this Agreement by the Parties, the Optionee, the Company, F-star Biotechnologische Forschungs-und entwicklungsges.m.b.h (F-star GmbH) and F-star Biotechnology Limited (F-star Ltd.) are entering into that certain license and collaboration agreement (the License Agreement) pursuant to which the Company will grant to the Optionee the option to license certain intellectual property rights to develop and commercialize products based on such intellectual property rights. |
IT IS AGREED as follows:
1. |
INTERPRETATION |
1.1. |
Definitions |
In this Agreement:
Approved Subcontractor | has the meaning given to it in the License Agreement; | |
Articles | means the Companys articles of association in force and effect from time to time; | |
Business Day | means a day (other than a Saturday or Sunday) on which banks generally are open for business in London, UK; |
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74
Buy-out Option Period | has the meaning given to it in the License Agreement; | |
Clinical Study | has the meaning given to it in the License Agreement; | |
Completion | means completion of the sale and transfer of the Option Shares to the Optionee in accordance with the terms of the SPA; | |
control | has the meaning given to it in section 1124 of the Corporation Tax Act 2010 and controlling shall be construed accordingly; | |
Decision Period | has the meaning given to it in clause 4.3; | |
Disclosure Documents | means the Disclosure Letter and the documents attached to the Disclosure Letter; | |
Disclosure Letter | means the pro-forma disclosure letter in the agreed form addressed to the Optionee from each of the Shareholders in accordance with the SPA; | |
Disclosure Notice | has the meaning given to it in clause 4.1; | |
Disclosure Period | has the meaning given to it in clause 4.2; | |
Disposal | has the meaning given to it in clause 12.1(a); | |
Effective Date | means the date of this Agreement; | |
Exercise Notice | means a notice in writing given by the Optionee to the Shareholders and the Company in accordance with clause 5.1 in the form set out in Schedule 3; | |
Extended Option Period | has the meaning given to it in clause 5.1; | |
Failure Event | has the meaning given to it in clause 8.1; | |
Failure Notice | has the meaning given to it in clause 8.1; | |
Gamma IP License | means the license agreement between the Company and F-star Ltd. dated on or around the date of this Agreement; | |
Gamma Service Agreement | means the service agreement entered into between the Company and F-star Ltd. dated on or around the date of this Agreement; | |
HSR Act | means the Hart-Scott-Rodino Antitrust Improvements Act; | |
Independent Expert | has the meaning given to it in clause 10.1; | |
Intellectual Property | has the meaning given to it in the SPA; | |
Lapse | means lapse of the Options in accordance with clause 3.1; | |
License Agreement | has the meaning given to it in Recital (C); | |
Option | has the meaning given to it in clause 2.1; | |
Option Fee | means a total aggregate amount of US$500,000; |
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75
Option Shares | means the Shares set out in Part 2 of Schedule 1 together with any other shares, stock or securities that the Shareholders (or their nominees) become legally or beneficially entitled to; | |
Paying Account | means the bank account with SunTrust Bank and administered by the Payments Administrator; | |
Payments Administrator | means Acquiom Clearinghouse LLC, a Delaware limited liability company; | |
Permitted F-
star Sale Transaction |
means a sale or transfer of the entire issued share capital of F-star GmbH that results in a third party owning, directly or indirectly, legal and beneficial title to such issued share capital; | |
Permitted Financing | means any subscription for further Shares or other equity securities in the Company contingent upon a subscription for shares in F-star GmbH; | |
Reorganisation |
means in relation to the Company:
a) a subdivision, consolidation or reclassification of the Option Shares;
b) a reduction of capital (of whatever nature, but excluding a cancellation of capital that is lost or not represented by available assets), or any other reduction in the number of Shares in issue from time to time;
c) an issue of Shares to the Shareholders by way of dividend or distribution; or
d) an issue of Shares to the Shareholders by way of capitalisation of profits or reserves (including share premium account and any capital redemption reserve); |
|
Shareholders Agreement | means the shareholders agreement between the Shareholders and the Company dated 24 August 2016; | |
Shareholders Proportions | means in relation to the Shareholders, that proportion which the number of Option Shares being sold by a Shareholder bears to the total number of Option Shares (as illustrated in column 3 of the table set forth in Part 2 of Schedule 1); | |
Shares | means the equity share capital of the Company from time to time (as defined in section 548 of the Companies Act 2006); | |
SPA | has the meaning given to it in Recital (B); | |
Third Party Offer | means an offer by a third party for such part of the issued share capital of the Company that would result in the third party obtaining control of the Company; and | |
Warrantors | has the meaning given to it in the SPA. |
1.2. |
Clause, Schedule and paragraph headings shall not affect the interpretation of this Agreement. |
1.3. |
References to clauses and Schedules are to the clauses and Schedules of this Agreement and references to paragraphs are to paragraphs of the relevant Schedule. |
1.4. |
The Schedules form part of this Agreement and shall have effect as if set out in full in the body of this Agreement. Any reference to this Agreement includes the Schedules. |
1.5. |
A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality). |
1.6. |
A reference to a Party shall include that partys personal representatives, successors and permitted assigns. |
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1.7. |
Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular. |
1.8. |
Unless the context otherwise requires, a reference to one gender shall include a reference to the other genders. |
1.9. |
A reference to writing or written includes fax or e-mail (unless otherwise expressly provided in this Agreement). |
1.10. |
Any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms. Where the context permits, other and otherwise are illustrative and shall not limit the sense of the words preceding them. |
1.11. |
A reference to a document in this Agreement in the agreed form is to a document agreed by the Parties and initialled by them or on their behalf for identification purposes. |
1.12. |
Where any obligation in this Agreement is expressed to be undertaken or assumed by any Party, that obligation is to be construed as requiring the Party concerned to exercise all rights and powers of control over the affairs of any other person which it is able to exercise (whether directly or indirectly) in order to secure performance of the obligation. |
1.13. |
References to any English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any other legal concept shall, in respect of any jurisdiction other than England, be deemed to include the legal concept which most nearly approximates in that jurisdiction to the English legal term. |
1.14. |
A reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time. |
1.15. |
References to US$ or $ are references to US Dollars, legal tender in the United States, and references to £ are references to Pounds Sterling, legal tender in the United Kingdom. |
2. |
GRANT OF OPTIONS |
2.1. |
In consideration of the payment of the Option Fee to the Shareholders, each of the Shareholders hereby grants to the Optionee an unconditional and irrevocable option (each an Option and collectively, the Options) to purchase its respective Option Shares on the terms set out in this Agreement. |
2.2. |
The Option Fee shall be apportioned between the Shareholders in the Shareholders Proportions. |
2.3. |
The Optionee shall, on the date of this Agreement, pay the Option Fee in US Dollars by electronic transfer in immediately available funds to the Paying Account. Payment to the Payments Administrator in accordance with this clause 2.3 shall be a good and valid discharge of the obligations of the Optionee to pay the Option Fee to the Shareholders, and the Optionee shall not be concerned to see the application of the monies so paid. |
2.4. |
In the event that the Optionee becomes aware that it will have an obligation to deduct or withhold an amount for or on account of taxes from any payment made under this Agreement, it shall notify the Company (if prior to Completion) or the Shareholders Representative (on or after Completion) in writing as soon as reasonably practicable and the Parties shall use their reasonable endeavours to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double |
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taxation agreement, treaty or domestic exemption which may apply to eliminate or reduce withholding taxes and otherwise provide the Shareholders with such assistance as is reasonably required to obtain a refund of the withheld or similar taxes, or obtain a credit with respect to such taxes. In the event there is no applicable double taxation agreement, treaty or domestic exemption or if an applicable double taxation agreement, treaty or domestic exemption reduces but does not eliminate such withholding or similar tax, the Optionee shall deduct the amount paid from the amount due to the respective Shareholder or Shareholders, remit such withholding or similar tax to the appropriate tax authority and secure and send to the respective Shareholder or Shareholders reasonable evidence of the payment of such withholding or similar tax. In the event that any taxes are required by applicable tax law to be withheld or deducted for on account of tax from any payments made under this Agreement, any taxes so withheld and deducted from any payment by the Optionee and paid over to the proper taxing authority shall be treated as paid to the Shareholders under this Agreement. |
3. |
BUY-OUT OPTION PERIOD |
3.1. |
The Options may be exercised in whole (and not in part) with respect to all Shareholders during the Buy-out Option Period (and if applicable any Extended Buy-out Option Period), and if the Options are not exercised during such period, they shall lapse (Lapse). |
3.2. |
For the purposes of this clause 3, the date of exercise of the Option is the earlier of (i) the date on which the Optionee serves the Exercise Notice on the Company and the Shareholders Representative and (ii) the date on which the Company and the Shareholders Representative are deemed to receive the Exercise Notice in accordance with clause 22. |
4. |
DISCLOSURE |
4.1. |
Optionee shall be entitled at any time during the Buy-out Option Period (but prior to service by the Optionee of an Exercise Notice on the Company and the Shareholders Representative) in accordance with clause 5.1 to serve notice in writing on the Company in accordance with clause 22 (the Disclosure Notice) requiring the Shareholders to procure that the Company delivers to the Optionee: |
(a) |
the Disclosure Documents; |
(b) |
the persons proposed to be Warrantors under the SPA; and |
(c) |
such other information regarding the Company and its assets, liabilities and business activities as Optionee may reasonably request. |
4.2. |
The Shareholders shall procure that Company shall deliver the items in clause 4.1(a) and 4.1(b) within [***] of receipt of the Disclosure Notice (the Disclosure Period) and the items in clause 4.1(c) within a reasonable time period following receipt of the Disclosure Notice. If the Company and/or the Shareholders become aware of additional information that should have been disclosed under clause 4.1(a) after the Disclosure Period but before receipt by the Company of an Exercise Notice pursuant to clause 5, they shall promptly provide such information to Optionee. The Disclosure Letter delivered to the Optionee pursuant to clause 4.1 shall serve as the Disclosure Letter delivered pursuant to the SPA. |
4.3. |
The Shareholders shall be entitled, by notice in writing from the Shareholders Representative to the Optionee (to be received by the Optionee no later than [***] prior to the expiry of the Disclosure Period), to one extension of the Disclosure Period by [***]. For the avoidance of doubt, the right of extension set out in this clause 4.3 applies once per Disclosure Period. |
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4.4. |
Subject to clause 4.5, if the Optionee does not serve an Exercise Notice on the Shareholders Representative and the Company in accordance with clause 22 within [***] following the later of (i) expiry of the Disclosure Period and (ii) the date on which the Company has delivered the items required to be delivered under clauses 4.1(a), 4.1(b) and 4.1(c) (such [***] period, the Decision Period) it shall be required to reimburse the Company and the Shareholders in respect of all costs reasonably incurred by them (including professional advisers fees) as a result of complying with their obligations under this clause 4, save where the Disclosure Documents reveal any matter which is, or is reasonably likely to become, materially adverse to the medium-term or long-term prospects of the Company. |
4.5. |
In the event that the Company and/or any Shareholder provides the Optionee with additional information after the Disclosure Period, the Decision Period shall be extended by an additional [***]. |
4.6. |
The Optionee shall pay any amounts due to the Company or the Shareholders as a result of clause 4.3 by electronic transfer in immediately available funds to the Paying Account within [***] of certification from the Company as to the relevant amounts. |
4.7. |
In the event that any of [***] ceases to be employed or otherwise engaged by F-star GmbH (or any of its Affiliates) in a management position or ceases to own (legally or beneficially) Shares then they shall cease to be a Warrantor and shall be replaced as a Warrantor by the person then performing the role of [***] or, in any case, by such person as the Company, acting reasonably, may nominate in writing in the Disclosure Documents provided that such person owns Shares (legally or beneficially), performs a senior management role in the Company and the Buyer consents to the appointment, such consent not to be unreasonably withheld, conditioned or delayed. |
5. |
EXERCISE |
5.1. |
The Options may be exercised during the Buy-out Option Period by the Optionee serving an Exercise Notice on the Company and the Shareholders Representative in accordance with clause 22, provided that the Optionee shall not be entitled to serve an Exercise Notice unless it has previously served a Disclosure Notice on the Company in accordance with clause 4.1 and the Exercise Notice is being served within the Decision Period corresponding to such Disclosure Notice, provided further that if the Company does not deliver the items set out in clause 4.1(a) and clause 4.1(c) to the Optionee within the Disclosure Period (subject to extension in accordance with clause 4.3), (i) the Buy-out Option Period shall, notwithstanding its ordinary term, continue until the date that is [***] after the Company has delivered the items required to be delivered under clause 4.1(a) and clause 4.1(b) (such additional period, the Extended Buy-out Option Period); and (ii) the Optionee shall be entitled to serve an Exercise Notice on the Company and the Shareholders Representative in accordance with clause 22 (and thereby exercise the Options) notwithstanding the fact that the Disclosure Documents have not been delivered to the Optionee. |
5.2. |
The Options must be exercised in respect of all of the Option Shares and not in respect of some Options Shares only. |
5.3. |
For the avoidance of doubt, all dividends and other distributions resolved or declared to be paid or made by the Company in respect of the Option Shares by reference to a record date which falls on or before Completion shall belong to and be payable to the Shareholders in accordance with the rights attaching to such shares in the Articles. |
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6. |
ACTIONS FOLLOWING EXERCISE |
6.1. |
In the event that the Optionee exercises the Options in accordance with clause 5, the Parties, including each of the Shareholders shall, and the Company shall cause the Shareholders Representative to execute the SPA within [***] of receipt of the Exercise Notice by the Company and the Shareholders Representative, and consummate the transactions contemplated thereby. |
6.2. |
Without limitation on the foregoing obligation or on any remedies that Optionee may elect to exercise in respect of any breach thereof, each Shareholder hereby constitutes and appoints Optionee, with full power of substitution, as its true and lawful agent and attorney-in-fact, with full power and authority in its name, place and stead, to execute and deliver the SPA, if and only if the Shareholder fails to execute the SPA within the [***] period specified above. |
7. |
COMPETITION REVIEW |
7.1. |
If the act of exercise of the Option or Completion requires the making of filings under the HSR Act, or under any similar pre-merger or antitrust notification provision in the European Union or any other jurisdiction, then all rights and obligations related to the Optionee exercising the Option or the Optionees decision not to proceed with the exercise of the Option will be tolled until the applicable waiting period has expired or been terminated or until approval or clearance from the reviewing authority has been received, and each Party agrees to use its reasonable endeavours to make any such filings and respond to any request for information to expedite review of such transaction and minimize or avoid any delays in payments. |
7.2. |
If the antitrust enforcement authorities in the U.S. make a second request under the HSR Act, or any antitrust enforcement authority in another jurisdiction commences an investigation related to the Optionee exercising the Option or a decision by the Optionee not to exercise the Option, then the Parties will, in good faith, cooperate with each other and use reasonable endeavours to: |
(a) |
resolve all enforcement agency concerns about the transaction under investigation; and |
(b) |
oppose any enforcement agency opposition to such transaction. |
If the enforcement agency files a formal action to oppose the transaction, the Parties will confer in good faith to determine the appropriate strategy for resolving the enforcement agency opposition, including, and where appropriate, the renegotiation of their obligations under this Agreement with respect to the exercise of the Option, with the objective of placing each Party, to the maximum extent possible, in the same economic position that each Party would have occupied if the Optionees decision to proceed with exercise of the Option or not to proceed with exercise of the Option had been permitted. Notwithstanding the foregoing, the Optionee shall direct, in its sole discretion, the response of the Parties to any enforcement agency opposition save that the Shareholders shall not be required to take any action not specified in this clause 7. The Optionee may withdraw, without penalty, the exercise of the Options if the Parties are unable to resolve the enforcement agency opposition. In addition, nothing in this clause 7 will require either Party to:
(i) |
divest, sell, license or otherwise dispose of any assets, entities or facilities, |
(ii) |
litigate or contest any administrative or judicial action or proceeding or any decree, judgment, injunction or other order, whether temporary, preliminary or permanent; or |
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(iii) |
make proposals, execute or carry out agreements or submit to orders providing for: |
(A) |
the discontinuation of any product or service of a Party; |
(B) |
the licensing or provision of any technology or other Intellectual Property of a Party to any person; |
(C) |
the imposition of any limitation or regulation on the ability of a Party to freely conduct their business or own their respective assets; or |
(D) |
the holding separate of the Shares or any limitation or regulation on the ability of the Optionee to exercise full rights of ownership of the Shares. |
8. |
FAILURE TO SELL |
8.1. |
If, following exercise of the Options by the Optionee: |
(a) |
any Shareholder breaches its obligations under clause 6 of this Agreement; and/or |
(b) |
the Optionee is otherwise unable to acquire one hundred per cent. (100%) of the issued share capital of the Company pursuant to the SPA, |
(each such event being a Failure Event), the Optionee shall provide notice in writing to the Company within [***] of becoming aware of such Failure Event (a Failure Notice) and the Shareholders shall have [***] following receipt of the Failure Notice by the Company to cure the relevant Failure Event to the reasonable satisfaction of the Optionee.
8.2. |
If a Failure Event occurs and is not cured to the reasonable satisfaction of the Optionee in accordance with clause 8.1, each Shareholder agrees and acknowledges that it shall vote its Option Shares and enforce any and all applicable terms under the Companies Act 2006, the Articles and the Shareholders Agreement, including but not limited to the drag right set out in article 18 of the Articles, in order to cause each Shareholder whose breach contributed to the Failure Event to effect compliance with its obligations under this Agreement. |
8.3. |
In the event of a conflict between this Agreement and the Articles prior to termination of this Agreement pursuant to clause 18, , each Shareholder agrees and acknowledges that the terms of this Agreement shall prevail and that it shall, to the extent it is lawful to do so, vote its Option Shares and enforce any and all applicable rights it holds (whether under the Companies Act 2006, the Articles and the Shareholders Agreement, or otherwise) , including but not limited to the drag right set out in article 18 of the Articles, in order to amend the Articles to reflect the terms of this Agreement. |
8.4. |
In the event of a conflict between this Agreement and the Shareholders Agreement prior to termination of this Agreement pursuant to clause 18, each Shareholder agrees and acknowledges that the terms of this Agreement shall constitute a waiver of the conflicting terms under the Shareholders Agreement. Notwithstanding clause 25 of the Shareholders Agreement, the Shareholders shall not modify the Articles such that the Articles are in conflict with this Agreement. |
9. |
REORGANISATION |
9.1. |
If any Reorganisation takes place after the date of this Agreement but before Completion, all shares, stock and other securities (if any) to which the Shareholders (or their nominees) become legally or beneficially entitled as a result of each such Reorganisation, and which derive (whether directly or indirectly) from the Option Shares, shall be deemed to be subject to the Option provided that nothing in this clause 9 shall be construed as imposing any obligations on the Shareholders either to exercise or to refrain from exercising any rights or powers conferred on them by or deriving from the Option Shares. |
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9.2. |
In the event of any Reorganisation with respect to the Option Shares occurring after the date of this Agreement but before Completion, all references in this Agreement to specified numbers of Option Shares of any class or series affected thereby, and all calculations provided for that are based upon numbers of Option Shares of any class or series (or trading prices therefor) affected thereby, shall be equitably adjusted to the extent necessary to provide the Parties the same economic effect as contemplated by this Agreement prior to such Reorganisation. In accordance with clause 20.1, the Parties shall amend the SPA as necessary to reflect the effect of the Reorganisation on the Company and the Option Shares. |
9.3. |
References in this Agreement to the Option Shares shall be construed to give full effect to clause 9.1. |
10. |
DETERMINATION BY AN EXPERT |
10.1. |
Any dispute about the effect of a Reorganisation shall be referred to an independent expert (the Independent Expert) to be appointed by agreement in writing between the Optionee and the Company within [***] of the dispute or, failing such agreement, to be appointed by the President (or his nominee) of the Institute of Chartered Accountants in England and Wales. |
10.2. |
The Independent Expert shall use all reasonable endeavours to reach its conclusions under this clause 10 within [***]. |
10.3. |
The Independent Expert shall act as an expert and not as an arbitrator and shall determine the effect of a Reorganisation, which may include any issue involving the interpretation of any provision of this Agreement, its jurisdiction to determine the matters and issues referred to it or its terms of reference. The Independent Experts written decision on the matters referred to them shall, in the absence of manifest error or fraud, be final and binding on the Parties. |
10.4. |
Each Party shall bear its own costs in relation to the reference to the Independent Expert. |
11. |
WARRANTIES |
11.1. |
Each Shareholder warrants to the Optionee on a several basis that: |
(a) |
it has full power and authority to grant the Option on the terms and conditions of this Agreement and, if the Shareholder is not a natural person, the grant of the Option has been duly and validly approved and authorized by all necessary action on the part of such Shareholder; |
(b) |
no consent, approval, order, authorization, release or waiver of, or registration, declaration or filing with, any governmental or regulatory authority is necessary or required to be made or obtained by such Shareholder to enable the Shareholder to execute, deliver, enter into, and perform its obligations under this Agreement; |
(c) |
if such Shareholder is not a natural person, it has been duly incorporated and is validly existing and in good standing under the laws of the jurisdiction in which it is incorporated or constituted (to the extent that such concepts are recognised in such jurisdiction); |
(d) |
this Agreement, when executed by the Parties, shall constitute a legal, valid and binding obligation of such Shareholder enforceable against it in accordance with its terms; |
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(e) |
it is the legal and beneficial owner of the Option Shares set out beside its name in Part 2 of Schedule 1, such Option Shares are fully paid and may be sold free of all encumbrances and the Shareholder has not entered into any agreement, arrangement or obligation to give or create any such encumbrance over its Option Shares; |
(f) |
the Option Shares represent one hundred per cent (100%) of the share capital of the Company issued or agreed to be issued and there is no option or right outstanding to subscribe for any share or loan capital of the Company; |
(g) |
it has full voting power with respect to its proportion of the Option Shares, none of which are subject to any proxy, voting trust or other agreement or arrangement with respect to the voting of such Option Shares; and |
(h) |
as of the Effective Date, the Shareholder is not engaged in any litigation, arbitration or other dispute resolution process, or administrative or criminal proceedings, whether as claimant, defendant or otherwise with respect to its Option Shares and, to the best of the Shareholders knowledge, there is no such action pending. |
11.2. |
The Company warrants to the Optionee that save for non-material matters relating to the Companys day-to-day operation, the Company has not engaged in any activities or conducted any operations other than as contemplated by or necessary for the License Agreement, the Gamma IP License, the Shareholders Agreement or the Gamma Service Agreement. |
11.3. |
The Optionee warrants to each of the Shareholders that: |
(a) |
it is duly organised, validly existing and in good standing under the laws of the State of Delaware, United States, and that the consummation of the transactions contemplated hereby is within Optionees corporate powers and have been duly authorized by all necessary corporate actions on the part of Optionee. Optionee has full corporate power and authority to execute, deliver and perform this Agreement; |
(b) |
this Agreement has been duly authorized, executed and delivered by Optionee and constitutes a legal, valid and binding obligation of Optionee enforceable against Optionee in accordance with its terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors rights generally and general equitable principles; and |
(c) |
it has the financial wherewithal, in the form of cash on hand or available borrowing facilities, to pay the Option Fee. |
12. |
OPTIONEE PROTECTIONS |
12.1. |
Save as permitted by clause 12.2, until the earlier of Completion and Lapse, the Shareholders shall not, without the prior written consent of the Optionee (such approval not to be unreasonably withheld or conditioned, it being understood that it shall not be considered unreasonable for Optionee to withhold consent for any of the following matters unless the same are contemplated by or necessary for the License Agreement, the Gamma IP License, the Shareholders Agreement or the Gamma Service Agreement): |
(a) |
sell, transfer or otherwise dispose of, or mortgage, charge, pledge or otherwise encumber or create any interest over or in respect of (each a Disposal) its legal or beneficial interest in any of the Option Shares (or any interest in any of them); |
(b) |
enter into any contract, option or other agreement, arrangement or understanding with respect to any Disposal of any or all of such Shareholders Option Shares, or any right or interest therein; |
(c) |
grant or permit the grant of any proxy, power-of-attorney or other authorization or consent in or with respect to any or all of such Shareholders Option Shares; |
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(d) |
deposit or permit the deposit of any or all of such Shareholders equity interests in the Company, including any Option Shares, into a voting trust or enter into a voting agreement or arrangement with respect to any of such equity interests, including the Option Shares, except as expressly contemplated by this Agreement; or |
(e) |
take or permit any other action that would in any way restrict, limit, delay or interfere with the performance of such Shareholders obligations hereunder or the transactions contemplated hereby or otherwise make any representation or warranty of such Shareholder herein untrue or incorrect. |
12.2. |
Clause 12.1 shall not apply to: |
(a) |
a Disposal of all of the Option Shares where the sole purpose of such Disposal is to create a holding company (the Holding Company) that will be owned in whole or in part by the Shareholders, provided that prior to making any such Disposal, the Holding Company shall have entered into a new call option agreement (that is conditional upon the Disposal) with the Optionee and the Company relating to the shares in the Company in a form that provides the Optionee with the same benefits as this Agreement for the same consideration, or otherwise in a form and substance reasonably acceptable to the Optionee; |
(b) |
a Disposal of any Option Shares that is in accordance with the Articles, provided that prior to making any such Disposal, the transferee shall enter into a deed of adherence in respect of this Agreement in respect of the Option Shares so transferred and shall be construed as a Shareholder hereunder. No Disposal by a Shareholder in accordance with this clause 12.2 shall relieve it of any liability under this Agreement; |
(c) |
a Disposal of all Option Shares in connection with a Third Party Offer that is conducted in conjunction with a Permitted F-star Sale Transaction and results in the transfer of all Option Shares to the person that acquired (or shall acquire), directly or indirectly, the issued share capital in F-star GmbH pursuant to the Permitted F-star Sale Transaction, or to a direct or indirect wholly owned subsidiary thereof (the F-star Acquiring Party), provided that prior to making any such Disposal, the F-star Acquiring Party shall have entered into a new call option agreement (conditional upon completion of the Permitted F-star Sale Transaction) with Optionee and the Company relating to the Shares in a form that provides the Optionee with the same economic benefit as this Agreement, or otherwise in a form and substance reasonably acceptable to Optionee; or |
(d) |
any other Disposal of Option Shares on terms agreed in writing between the Optionee and the Shareholders. |
12.3. |
In accordance with clause 20.1, the Parties shall amend the SPA as necessary to reflect the effect of any Disposal or Permitted Financing permitted pursuant to the terms of this clause 12 or elsewhere in this Agreement. |
12.4. |
Until the earlier of Completion and Lapse, each Shareholder shall in respect of any resolution of the Companys shareholders (whether proposed at a meeting, in writing or otherwise) vote its Option Shares and not rescind such vote: |
(a) |
in favour of the transactions and matters contemplated by this Agreement and the SPA (including, but not limited to, the enforcement of clause 8.2 of this Agreement); and |
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(b) |
save as set out in clause 12.2, against: |
(i) |
any proposal by the Company or any Shareholder that would in any material respect impede, delay, interfere with or prevent the exercise of the Options or the transactions contemplated by this Agreement or the SPA; |
(ii) |
any changes to the Articles or the adoption of new articles of association; |
(iii) |
any Third Party Offer; and |
(iv) |
any action, proposal, transaction or agreement that could reasonably be expected to result in a breach of any covenant, representation or warranty or any other obligation or agreement of such Shareholder or the Company under this Agreement or the SPA. |
12.5. |
Until the earlier to occur of Completion and Lapse, each Shareholder hereby irrevocably appoints the Optionee and any designee of the Optionee as its duly authorised agent and attorney (with full power of substitution) to act for and in the name of such Shareholder and to take such actions as the Optionee (or its duly appointed designee) in its absolute discretion sees fit, including (but not limited to) executing any document, whether as a deed or otherwise, receiving notice of and attending any meeting of the Company and voting the Shareholders Option Shares (whether in person or by written resolution), as may be necessary to give full effect to clause 12.4. Each Shareholder agrees and accepts that the powers granted to the Optionee in this clause 12.5 are given by way of security to secure the performance of such Shareholder of its obligations under this Agreement. |
12.6. |
Until the earlier of Completion and Lapse the Company shall (and to the extent it is reasonably within their control, the Shareholders shall procure that the Company shall): |
(a) |
save for non-material matters relating to the Companys day-to-day operation, conduct only such activities as are contemplated by, necessary for or related to the Companys performance of its obligations under the License Agreement, the Gamma IP License, the Gamma Service Agreement, the Shareholders Agreement and the Articles (and the Companys other constitutional documents), or as consented to in writing by the Optionee (such consent not to be unreasonably withheld, conditioned or delayed); and |
(b) |
(i) pay all material debts and Taxes (as defined in the SPA) of the Company when due, subject to good faith disputes over such debts or Taxes and (ii) pay or perform all other obligations when due, subject to good faith disputes and other reasonable commercial considerations; and |
(c) |
promptly notify the Optionee upon learning of any change, occurrence or event which, individually or in the aggregate with any other changes, occurrences and events, could reasonably be expected to have a material adverse effect on the Company. |
12.7. |
Until the earlier to occur of Completion and Lapse and without limiting the generality or effect of the provisions of clause 12.6, the Company shall not and, to the extent it is reasonably within their control, the Shareholders shall procure that the Company shall not (except to the extent expressly provided otherwise in this Agreement, as consented to in writing by Optionee, or as set forth in the License Agreement, the Gamma IP License, the Gamma Service Agreement, the Shareholders Agreement, the Articles (or other constitutional document of the Company) or any other agreement with an Approved Subcontractor appointed pursuant to the License Agreement): |
(a) |
enter into any contract that would constitute a Material Contract (as defined in the SPA), or violate, terminate, amend, or otherwise modify (including by entering into a new contract with such party or otherwise) or waive any of the terms of any of its Material Contracts including without limitation the License Agreement, the Gamma IP License or the Gamma Service Agreement; |
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(b) |
issue or allot any Shares or securities convertible into, or subscriptions, rights, warrants or options to acquire, or other contracts of any character obligating it to issue any such Shares or other convertible securities, other than in connection with a Permitted Financing; provided that any party acquiring such Shares shall enter into a deed of adherence in respect of this Agreement in respect of such Shares and shall be construed as a Shareholder hereunder; |
(c) |
transfer or license to any person any rights to any Intellectual Property, including, without limitation, Intellectual Property subject to the License Agreement; |
(d) |
sell, lease, license or otherwise dispose of any properties or assets that are material to its business or enter into any contract purporting to give effect to any of the foregoing; |
(e) |
take any action regarding a patent, patent application or other Intellectual Property right, other than filing continuations for existing patent applications or completing or renewing registrations of existing patents, domain names, trademarks or service marks in the ordinary course of business; |
(f) |
make any loans or advances to, or any investments in or capital contributions to, any person, or forgive or discharge in whole or in part any outstanding loans or advances, or prepay any indebtedness for borrowed money; |
(g) |
incur indebtedness in excess of [***] in any financial year or enter into or otherwise guarantee any such indebtedness; or |
(h) |
place or allow the creation of any encumbrance on any of its properties. |
13. |
THIRD PARTY OFFERS |
Until the earlier to occur of Completion and Lapse, each Shareholder will notify the Optionee promptly following receipt by such Shareholder of any letter of intent, agreement in principle, tender agreement, support agreement or other similar agreement relating to a potential Third Party Offer. Notwithstanding the foregoing, but save in connection with a potential Permitted F-star Sale Transaction, no Shareholder or the Company shall:
(a) |
initiate, solicit, seek or knowingly encourage or knowingly facilitate (including in each case by way of providing information regarding the Company) any inquiries, proposals or offers with respect to or that could reasonably be expected to lead to, or the making, announcement, submission or the completion of, a Third Party Offer; |
(b) |
knowingly participate or knowingly engage in or continue any discussions or negotiations with, or furnish or disclose any non-public information (other than in the ordinary course of business unrelated to a Third Party Offer) relating to the Company, or otherwise knowingly cooperate with, facilitate or assist any person in connection with a Third Party Offer; |
(c) |
approve, endorse or recommend, or publicly announce the intent to approve, endorse or recommend, any Third Party Offer; |
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(d) |
enter into any letter of intent, agreement in principle, merger agreement, acquisition agreement, option agreement or other similar agreement relating to a Third Party Offer; or |
(e) |
save as contemplated in this Agreement, effect a transaction that could result in a third party obtaining control of the Company (other than the transactions contemplated by the SPA). |
14. |
CONFIDENTIALITY |
14.1. |
Except (i) as provided in the License Agreement, the Gamma IP License or the Gamma Service Agreement and (ii) to the extent required by law or any legal or regulatory authority of competent jurisdiction: |
(a) |
no Party shall at any time disclose to any person (other than to its professional advisers) the existence of, or terms of this Agreement or any trade secret or other confidential information relating to the Company (or relating to any other Party), or make any use of such information other than to the extent necessary for the purpose of exercising or performing its rights and obligations under this Agreement; and |
(b) |
except with the prior written consent of the relevant Parties (such approval not to be unreasonably withheld or delayed), no Party shall make, or permit any person to make, any public announcement, communication or circular concerning this Agreement. |
14.2. |
The undertakings in clause 14.1 are given by each Party to each other Party and, in respect of undertakings relating to the trade secrets and confidential information of the Company, to the Company and apply to actions carried out by each Party in any capacity and whether directly or indirectly, on the Partys own behalf, on behalf of any other person or jointly with any other person. |
14.3. |
The Shareholders undertake to the Optionee, and the Optionee undertakes to the Shareholders, to keep confidential the existence of this Agreement and, in the case of the Optionee, all information which it has acquired about the Company, and to use the information only for the purposes contemplated by this Agreement. |
14.4. |
Any Party may disclose any information that it is otherwise required to keep confidential under this clause 14: |
(a) |
to such of its professional advisers, consultants and employees or officers as are reasonably necessary to advise on this Agreement, or to facilitate the exercise of the Options, provided that the disclosing party procures that the people to whom the information is disclosed keep it confidential as if they were that party; or |
(b) |
with the written consent of the other Parties; or |
(c) |
to the extent that the disclosure is required: |
(i) |
by law; or |
(ii) |
by a regulatory body, tax authority or securities exchange, but shall use reasonable endeavours to consult the other Parties and to take into account any reasonable requests they may have in relation to the disclosure before making it. |
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15. |
SHAREHOLDERS REPRESENTATIVE |
Pursuant to the terms of the SPA, the Shareholders Representative will, with effect from Completion be irrevocably appointed to act as the Shareholders sole representative agent and attorney-in-fact and to act on their behalf for the purposes of this Agreement, the SPA and each agreement and document ancillary thereto. The Shareholders agree to the exculpation and indemnification provisions in favor of the Shareholders Representative in the SPA.
16. |
FURTHER ASSURANCE |
At its own expense, each Shareholder, the Company and the Optionee shall, and shall use all reasonable endeavours to procure that any necessary third party shall, promptly execute and deliver such documents and perform such acts as the other parties may reasonably require for the purpose of giving full effect to this Agreement.
17. |
ASSIGNMENT |
No Party shall assign, transfer, mortgage, charge, subcontract, declare a trust over or deal in any other manner with any or all of its rights and obligations under this Agreement (or any other document referred to in it) without the prior written consent of the Shareholders Representative (if after Completion), the Company, and the Optionee.
18. |
TERMINATION |
18.1. |
Subject to clause 18.2, this Agreement shall terminate and cease to have further force or effect upon the first to occur of (i) Completion in accordance with the SPA; or (ii) 60 Business Days following the date on which the Options Lapse, unless Optionee has delivered an Exercise Notice prior to the date on which the Options Lapse, in which case this Agreement shall remain in effect until Completion. |
18.2. |
On termination of this Agreement, the following clauses shall continue in force: clauses 1, 8, 14, 15, 26, 27 and 28. |
19. |
ENTIRE AGREEMENT |
19.1. |
This Agreement (together with the documents referred to in it) constitutes the entire agreement between the Parties and supersedes and extinguishes all previous discussions, correspondence, negotiations, drafts, agreements, promises, assurances, warranties, representations, arrangements and understandings between them, whether written or oral, relating to its subject matter. |
19.2. |
Each Party acknowledges that in entering into this Agreement (and any documents referred to in it), it does not rely on and shall have no remedies in respect of, any statement, representation, assurance or warranty (whether made innocently or negligently) that is not set out in this Agreement (or those documents). |
19.3. |
Nothing in this clause 19 shall limit or exclude any liability for fraud. |
20. |
VARIATION AND WAIVER |
20.1. |
No variation of this Agreement shall be effective unless it is in writing and signed by or on behalf of the Shareholders Representative, the Company, and the Optionee (or their authorised representatives). |
20.2. |
No failure or delay by a Party to exercise any right or remedy provided under this Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall prevent or restrict the further exercise of that or any other right or remedy. A waiver of any right or remedy under this Agreement or by law is only effective if it is in writing. |
20.3. |
Except as expressly provided in this Agreement, the rights and remedies provided under this Agreement are in addition to, and not exclusive of, any rights or remedies provided by law. |
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21. |
COSTS |
Except as expressly provided in this Agreement, each Party shall pay its own costs and expenses incurred in connection with the negotiation, preparation, execution and performance of this Agreement (and any documents referred to in it).
22. |
NOTICES |
22.1. |
Any notice or other formal communication to be given under this Agreement shall be in writing and shall be delivered by hand or sent by prepaid recorded delivery, special delivery, overnight courier, or registered post, or email to the relevant address in clause 22.2 and in each case it shall be marked for the attention of the relevant party set out in clause 22.2 (or as otherwise notified from time to time in accordance with the provisions of this clause 22). Any notice given by hand delivery or post shall be signed by or on behalf of the Party sending it and shall be deemed to have been duly given: |
(a) |
if hand delivered, when delivered; |
(b) |
if sent by recorded delivery, special delivery or registered post, at 10 am on the third Business Day from the date of posting; |
(c) |
if sent by overnight courier, one Business Day from the date of posting; or |
(d) |
if sent by email, when sent, |
unless there is evidence that it was received earlier than this and provided that, where (in the case of delivery by hand) the delivery or transmission occurs after 6 pm on a Business Day or on a day which is not a Business Day, service shall be deemed to occur at 9 am on the next following Business Day. References to time in this clause are to local time in the country of the addressee.
22.2. |
The addresses, email address and fax numbers of the Parties and the Shareholders Representative for the purpose of clause 22.1 are: |
Party and Contact |
Address | |||
F-star Gamma Limited |
Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT |
[***] | ||
Denali Therapeutics Inc. |
201 Gateway Boulevard, South San Francisco, California, United States |
[***] | ||
Shareholders Representative |
Shareholder Representative Services LLC, 1614 15th Street, Suite 200, Denver, CO 80202, United States |
deals@srsacquiom.com |
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[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] | ||
[***] | [***] | [***] |
22.3. |
A Party or the Shareholders Representative (as the case may be) may notify the other Parties of a change to its name, relevant addressee or address for the purposes of this clause 22, provided that such notice shall only be effective on: |
(a) |
the date specified in the notice is the date on which the change is to take place; or |
(b) |
if no date is specified or the date specified is less than five (5) Business Days after the date on which notice is given, the date following five (5) Business Days after notice of any change has been given. |
23. |
SEVERANCE |
23.1. |
If any provision of this Agreement or part-provision of this Agreement is or becomes invalid, unenforceable or illegal, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted. Any modification to or deletion of a provision or part-provision under this clause 23 shall not affect the validity and enforceability of the rest of this Agreement. |
23.2. |
If any provision or part-provision of this Agreement is invalid, illegal or unenforceable, the Parties shall negotiate in good faith to amend such provision so that, as amended, it is legal, valid and enforceable, and, to the greatest extent possible, achieves the intended commercial result of the original provision. |
24. |
THIRD PARTY RIGHTS |
A person who is not a party to this Agreement shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement.
25. |
COUNTERPARTS |
25.1. |
This Agreement may be executed in any number of counterparts, each of which when executed shall constitute a duplicate original, but all the counterparts shall together constitute the one agreement. |
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25.2. |
No counterpart shall be effective until each Party and the Shareholders Representative has executed at least one counterpart. |
26. |
GOVERNING LAW |
This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.
27. |
DISPUTE RESOLUTION |
27.1. |
If a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute), it shall be resolved pursuant to this clause 27. |
27.2. |
General |
Any Dispute shall first be referred to the Chief Executive Officer of the Optionee and John Haurum (or such other person nominated by the Company), who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by such persons shall be conclusive and binding on the Parties. If such persons are not able to agree on the resolution of any such issue within thirty (30) days (or such other period of time as mutually agreed by the Parties) after such issue was first referred to them, then either party may, by written notice to the other party, elect to initiate an alternative dispute resolution (ADR) proceeding pursuant to the procedures set forth in clause 25.3 for purposes of having the matter settled.
27.3. |
ADR |
Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in clause 15.7.3 of the License Agreement.
27.4. |
Interim Relief |
Notwithstanding anything herein to the contrary, nothing in this clause 27 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute following the ADR procedures set forth in clause 27.3, if necessary to protect the interests of such Party. This clause shall be specifically enforceable.
28. |
PROCESS AGENTS |
The Optionee irrevocably appoints Law Debenture Corporate Services Limited of Fifth Floor, Wood Street, London EC2V 7EX as its process agent to receive on its behalf service of process in any proceedings in England. Service upon the process agent shall constitute good and valid service on the Optionee whether or not the process is forwarded to or received by the Optionee. If for any reason the process agent ceases to act as process agent, resigns or no longer has an address in England, the Optionee irrevocably agrees to appoint a substitute process agent with an address in England acceptable to the Shareholders Representative (if after Completion) or the Company (if prior to Completion) and to deliver to the Shareholders Representative (if after Completion) or the Company (if prior to Completion) a copy of the substitute process agents acceptance
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of that appointment within 10 Business Days of the obligation to appoint arising. In the event that the Optionee fails to appoint a substitute process agent, it shall be effective service for the Shareholders, the Company or the Shareholders Representative to serve process upon the last known address in England of the last known process agent for the Optionee notified to the Shareholders, notwithstanding that such process agent is no longer found at such address or has ceased to act.
IT WITNESS whereof this Agreement has been entered into as a deed and is delivered on the date first aforementioned.
SCHEDULE 1
Part 1: The Shareholders
Name |
Address |
|
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] |
Part 2: The Option Shares
(1) Shareholder |
(2) No. of Ordinary
Shares |
(3) Shareholders
Proportion (%) |
||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
[***] |
[***] | [***] | ||
TOTAL = |
9,039,625 | 100% |
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SCHEDULE 2
The SPA
SPECIFIC TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH THREE ASTERISKS [***].
DATED 20[●●]
DENALI THERAPEUTICS INC. (1)
THE SELLERS (2)
and
SHAREHOLDER REPRESENTATIVE SERVICES LLC (as the Sellers Representative) (3)
SHARE PURCHASE AGREEMENT
relating to the entire issued share capital of
F-STAR GAMMA LIMITED
COOLEY (UK) LLP, DASHWOOD, 69 OLD BROAD STREET, LONDON EC2M 1QS, UK
T: +44 (0) 20 7583 4055 F: +44 (0) 20 7785 9355 WWW.COOLEY.COM
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CONTENTS
1. |
INTERPRETATION |
96 | ||||
2. |
SALE AND PURCHASE |
106 | ||||
3. |
CONSIDERATION |
107 | ||||
4. |
POST COMPLETION ADJUSTMENTS |
108 | ||||
5. |
COMPLETION |
109 | ||||
6. |
ESCROW ACCOUNT |
110 | ||||
7. |
SELLER WARRANTIES AND INDEMNITY |
111 | ||||
8. |
LIMITATIONS TO THE SELLERS LIABILITY |
112 | ||||
9. |
BUYERS WARRANTIES |
112 | ||||
10. |
POST COMPLETION MATTERS |
112 | ||||
11. |
BUYER GUARANTEE |
114 | ||||
12. |
SELLERS REPRESENTATIVE |
115 | ||||
13. |
PAYMENTS |
117 | ||||
14. |
ANNOUNCEMENTS |
118 | ||||
15. |
CONFIDENTIALITY |
118 | ||||
16. |
COSTS |
119 | ||||
17. |
GENERAL |
119 | ||||
18. |
ENTIRE AGREEMENT |
120 | ||||
19. |
ASSIGNMENT |
120 | ||||
20. |
NOTICES |
120 | ||||
21. |
COUNTERPARTS |
121 | ||||
22. |
GOVERNING LAW |
121 | ||||
23. |
DISPUTE RESOLUTION |
121 | ||||
24. |
PROCESS AGENTS |
122 | ||||
25. |
CONFLICT WAIVER |
122 |
Agreed Form Documents
1. Disclosure Letter
2. Escrow Agreement
3. Loan Notes Instrument
4. Press Release
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THIS SHARE PURCHASE AGREEMENT is executed and delivered as a DEED on
BETWEEN:
(1) |
THE PERSONS, whose names and addresses are set out in Schedule 1 (the Sellers); |
(2) |
DENALI THERAPEUTICS INC., a corporation organised and existing under the laws of the State of Delaware, United States, having its principal place of business at 201 Gateway Boulevard, South San Francisco, California, United States (the Buyer); and |
(3) |
SHAREHOLDER REPRESENTATIVE SERVICES LLC, a Colorado limited liability company and which is a party to this Agreement solely in its capacity as representative of the Sellers (the Sellers Representative). |
WHEREAS:
(A) |
The Company is a private limited liability company incorporated under the laws of England and Wales and engaged in the delivery of therapeutics across the blood brain barrier. |
(B) |
As at the date of this Agreement, the Sellers own the Shares that constitute the entire issued share capital of the Company. The Sellers have agreed to sell to the Buyer, and the Buyer has agreed to purchase and accept, the Shares on the terms of this Agreement. |
IT IS AGREED as follows:
1. |
INTERPRETATION |
1.1. |
Definitions |
In this Agreement:
Accepted Fcab Target | is defined in Schedule 5 (Contingent Consideration); | |
Accounting Policies | means the accounting policies and procedures set out in Part C of Schedule 4 (Accounting Policies); | |
Accounts | means the Companys individual accounts (as that term is used in sections 394 and 395 of the Companies Act) and cash flow statement for the financial year ended on the Last Accounting Date, the auditors report on those accounts, the directors report for that year and the notes to those accounts; | |
Actual Net Cash | has the meaning given to it in Schedule 4. | |
ADR | has the meaning given to it in clause 23.2; |
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Affiliate | means, with respect to a party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, control and, with correlative meanings, the terms controlling, controlled by and under common control with means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). The parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity. Affiliates shall be construed accordingly; | |
Business Day | means a day (other than a Saturday or Sunday) on which banks generally are open for business in London, UK; | |
Business Warranty | means [***], and Business Warranties means [***]; | |
Business Warranty Claim | means a claim by the Buyer for breach of a Business Warranty; | |
Buyers Account | means the bank account notified by the Buyer to the Sellers Representative from time to time; | |
Buyers Group | means the Buyer and the Buyers Group Undertakings; | |
Buyers Group Undertaking | means the Buyer or an undertaking which is a subsidiary undertaking or parent undertaking of the Buyer or a subsidiary undertaking of a parent undertaking of the Buyer and, for the avoidance of doubt, includes the Company from Completion, and Buyers Group Undertakings shall be construed accordingly; | |
Cash | means the aggregate of all cash held by the Company immediately following Completion, but excluding the Pass Through Amount; | |
Cash Sellers | means each of the Sellers other than the Loan Note Sellers; | |
Claim | means any Business Warranty Claim, Tax Warranty Claim, Special Indemnity Claim (including any Fraud Claim), Warrantor Fundamental Warranty Claim and/or Fundamental Warranty Claim, and Claims means any two or more of them; | |
Company | means F-star Gamma Limited, a private limited company incorporated under the laws of England and Wales under company number 10214672, having its registered office at Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT; | |
Company Confidential Information | means any Information or data relating to any Fcab or mAb2 Product, any Exploitation of any Fcab or mAb2 Product, any Know-How with respect thereto developed by or on behalf of Company or its Affiliates, or the scientific, regulatory or business affairs or other activities of the Company; | |
Completion | means completion of the sale and transfer of the Shares to the Buyer in accordance with the terms of this Agreement; |
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Completion Accounts | means the Draft Completion Accounts which have been agreed or determined in accordance with Part A of Schedule 4 (Preparation of Completion Accounts); | |
Completion Date | means the date on which Completion occurs; | |
Contingent Consideration | has the meaning given to it in paragraph 1 of Part A of Schedule 5 (Contingent Consideration); | |
Contingent Consideration Loan Notes | means the loan notes which may become issuable by the Buyer to certain of the Sellers following Completion pursuant to clause 3.5 and/or paragraph 2.3 of Schedule 5 (Contingent Consideration), to be constituted by the Loan Notes Instrument; | |
control | has the meaning given to it in section 1124 of the Corporation Tax Act 2010 and controlling shall be construed accordingly; | |
Declared Distributions | means all dividends and other distributions resolved or declared to be paid or made, by the Company in respect of the Shares by reference to a record date which falls on or before Completion; | |
Defaulting Party | has the meaning given to it in clause 5.4; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
Denali Fcab Notice | has the meaning given to it in the License Agreement, with respect to events and circumstances before Completion and has the meaning given to it in the Gamma IP License with respect to events and circumstances after Completion; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
Determination Date | means the date on which the Completion Accounts are agreed or determined in accordance with the provisions of Part A of Schedule 4 (Preparation of Completion Accounts); | |
Develop or Development | has the meaning given to it in the License Agreement; | |
Disclosure Documents | means the documents attached to the Disclosure Letter; | |
Disclosure Letter | means the letter from the Warrantors to the Buyer in relation to the Warranties and including the Disclosure Documents having the same date as this Agreement, the receipt of which has been acknowledged by the Buyer; | |
Dispute | has the meaning given to it in clause 23.1; | |
Disputed Business Warranty Claim | means any Business Warranty Claim that is not yet a Settled Business Warranty Claim, and Disputed Business Warranty Claims shall be construed accordingly; | |
Draft Completion Accounts | means a statement of assets and liabilities for the Company as at the Effective Time, in the form and with the line items set out in Part B of Schedule 4 (Completion Accounts) and which has been prepared in accordance with Part A of Schedule 4 (Preparation of Completion Accounts); |
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Effective Time | means 5 p.m. (London time) on the Completion Date; | |
Encumbrance | means a mortgage, charge, pledge, lien, option, restriction, right of first refusal, right of pre-emption, third-party right or interest, other encumbrance or security interest of any kind, or another type of preferential arrangement (including a title transfer or retention arrangement) having similar effect, including any such right or interest arising at Completion or otherwise in connection with this Agreement, and Encumbrances shall be construed accordingly; | |
Escrow Account | means the separately designated interest bearing US dollar deposit account with SunTrust Bank opened by the Escrow Agent and operated in accordance with the Escrow Agreement into which payment of the Escrow Amount will be made by the Buyer at Completion; | |
Escrow Agent | means SunTrust Bank to be appointed pursuant to the Escrow Agreement; | |
Escrow Agreement | means the agreement in the agreed form between the Buyer, the Sellers Representative and the Escrow Agent in relation to the Escrow Account; | |
Escrow Amount | means the lesser of (i) [***] and (ii) an aggregate amount equal to [***] of the Initial Amount (as rounded up to the nearest whole US dollar); | |
Estimated Net Cash | means such amount in US dollars as is notified in writing by the Sellers to the Buyer no later than 10 Business Days prior to the Completion Date that is the good faith estimate by the Sellers of the Net Cash as at the Effective Time; | |
Exercise Notice | has the meaning given to it in the Option Agreement; | |
Exploitation | has the meaning given to it in the License Agreement; | |
F-star | means F-star Biotechnology Limited, a private limited company incorporated under the laws of England and Wales under company number 08067987, having its registered office at Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT; | |
F-star GmbH | means F-star Biotechnologische Forschungs-und entwicklungsges.m.b.h, a limited liability company incorporated under the laws of the Republic of Austria; | |
Fairly Disclosed | has the meaning given to it in clause 7.5; | |
Fcab Delivery | is defined in Schedule 5 (Contingent Consideration); | |
Fraud Claim | means a claim in respect of fraud, wilful misconduct or wilful concealment by any of Warrantors (individually or on behalf of the Company) prior to Completion; | |
Fundamental Warranty | means [***] and Fundamental Warranties means [***]; | |
Fundamental Warranty Claim | means a claim by the Buyer for breach of a Fundamental Warranty; | |
Gamma IP License | means that certain license agreement between the Company and F-star dated 24 August 2016; | |
Gamma Service Agreement | means that certain services agreement between the Company and F-star dated 24 August 2016; |
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Guaranteed Obligations | means all present and future payment obligations and liabilities of the Company due, owing or incurred under clause 7.5.2 of the Gamma IP License to F-star (including, without limitation, under any amendment, supplement or restatement of the Gamma IP License; provided such amendment, supplement or restatement shall not increase the obligations of the Buyer without the express consent of the Buyer); | |
HMRC | means HM Revenue & Customs; | |
Indebtedness |
means the aggregate amount (expressed as a positive number) immediately following Completion of the following:
a) the principal and accrued interest on any outstanding borrowing or indebtedness in the nature of borrowing incurred by the Company including, without limitation, bank debt, loans, overdrafts, guarantees of indebtedness, letters of credit (which are secured by a third party), any loan notes or bonds, any other interest bearing and/or secured lending or credit liabilities provided by third parties to the Company and any early repayment, prepayment, or break costs, fees or penalties in respect of any such items and any legal costs and expenses in connection with the release of security in relation to any such borrowings;
b) all deferred indebtedness of the Company for the payment of the purchase price of property or assets purchased or services rendered (other than up to [***] of trade payables and other current liabilities incurred in the ordinary course of business);
c) all obligations of the Company to pay rent or other payment amounts under any lease up to and including the Completion Date;
d) reimbursement obligations of the Company with respect to letters of credit, bankers acceptances or similar facilities issued for the account of the Company and that are outstanding as at the Completion Date;
e) all obligations under any interest rate swap agreement, forward rate agreement, interest rate cap or collar agreement or other financial agreement or arrangement to which the Company is a party and which was entered into for the purpose of limiting or managing interest rate risks,
f) all obligations secured by any Encumbrance existing on property owned by the Company;
g) all premiums, penalties, fees, expenses, breakage costs and change of control payments required to be paid or offered in respect of any of the foregoing clauses (b) through (e) as a result of the consummation of the transactions contemplated by this Agreement or in connection with any lender consent;
h) all guaranties, endorsements, assumptions and other contingent obligations of the Company in respect of, or to purchase or to otherwise acquire, any of the obligations and other matters of the kind described in any of the clauses (a) through (g) appertaining to third parties; and
i) all liabilities for Taxes incurred by the Company up to, but not paid by, Completion; |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Information |
means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed; | |
Initial Amount |
means, where the Buyer serves an Exercise Notice on the Sellers Representative and the Company in accordance with the Option Agreement:
a) on a date prior to both [***];
b) on a date that is [***];
c) on a date that is [***]; or
d) after the time period in paragraph (c) above of this definition, [***]; |
|
Intellectual Property | means all intellectual property rights, whether registered or not, including pending applications for registration of such rights and the right to apply for registration or extension of such rights including patents, petty patents, utility models, design patents, designs, copyright (including moral rights and neighbouring rights), database rights, rights in integrated circuits and other sui generis rights, trade marks, trading names, company names, service marks, logos, the get-up of products and packaging and other signs used in trade, internet domain names, Know How and any rights of the same or similar effect or nature as any of the foregoing anywhere in the world; | |
Know How | means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions; |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Last Accounting Date | means 31 December of the financial year on which the Companys last audited financial statements and accounts were last required to be filed with the UK Registrar of Companies; | |
License Agreement | means that certain license and collaboration agreement among the Buyer, the Company, F-star GmbH and F-star, dated 24 August 2016; | |
Loan Note Escrow Account | means the separately designated interest bearing US dollar deposit account with SunTrust Bank opened by the Escrow Agent and operated in accordance with the Escrow Agreement into which payment of such amounts as required by clause 3.6 will be made by the Buyer; | |
Loan Note Sellers | each of the Sellers in Schedule 1 marked with an asterisk (*); | |
Loan Notes Instrument | means the loan notes instrument to be issued by the Buyer in the agreed form; | |
Management Accounts | means the unaudited monthly management accounts of the Company in respect of the period starting on the day after the Last Accounting Date and ending on the last day of the calendar month preceding the date of this Agreement for which such accounts have been prepared; | |
Material Contract | has the meaning given to it in clause 7.1.1 of Schedule 7; | |
Maximum Contingent Consideration |
means:
a) in the event of a [***], [***], provided that if an Initial Payment True Up Event subsequently occurs, then the Maximum Contingent Consideration will be [***];
b) in the event of a [***], provided that if an Initial Payment True Up Event subsequently occurs, then the Maximum Contingent Consideration will be [***];
c) in the event of a [***]; or
d) in the event of a [***], [***]; |
|
Net Cash | means an amount (which may be a positive or a negative number) equal to the Cash less the Indebtedness, less Transaction Costs and less Declared Distributions; | |
Non-defaulting Party | has the meaning given to it in clause 5.4; | |
Notice | has the meaning given to it in clause 20.1; | |
Option Agreement | means that certain option agreement related to the entire issued share capital of the Company among Buyer, the Company, the Sellers, and the Sellers Representative, dated 24 August 2016; | |
Pass Through Amount | means amounts payable by the Company to F-star pursuant to (i) clause 7.5.2 of the Gamma IP License that have been received by the Company from the Buyer pursuant to the License Agreement but not paid to F-star as of the Completion Date; | |
Payments Administrator | means Acquiom Clearinghouse LLC, a Delaware limited liability company; |
Confidential
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Payment Date | has the meaning given to it in paragraph 1 of Part A of Schedule 5 (Contingent Consideration); | |
Person | means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
Preliminary Determination Proceeding | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Press Release | means a press release regarding Completion in a form agreed between the Buyer and the Sellers; | |
Proportion of Initial Consideration | has the meaning given to it in clause 3.9; | |
Release Date | means the date which is [***] from Completion; | |
Relevant Shares | means, in relation to each Seller, the number and class of Shares held as at Completion set out adjacent to that Sellers name in column B of Schedule 1 (The Sellers); | |
Relief | means any loss, relief, exemption, allowance, deduction, credit or set-off in respect of Tax or relevant to the computation of Tax and any right to repayment of Tax; | |
Sellers Majority | means such of the Sellers who, immediately prior to Completion, together held not less than a majority in number of the Shares (as determined by reference to the Shares set out adjacent to each relevant Sellers name in column B of Schedule 1 (The Sellers)); | |
Set Off Claim | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Set Off Dispute Notice | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Set Off Notice | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Settled Business Warranty Claim |
means a Business Warranty Claim or part of a Business Warranty Claim the quantum of which is:
a) agreed in writing between the Buyer and the Sellers Representative;
b) determined by [***] court of competent jurisdiction; or
c) determined pursuant to the procedures set forth in clause 23.3; |
Confidential
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Settled Claim |
means a Settled Business Warranty Claim, or a Special Indemnity Claim, Fundamental Warranty Claim, or Warrantor Fundamental Warranty Claim (or part thereof), the quantum of which is:
a) agreed in writing between the Buyer and the Sellers Representative;
b) determined by [***] court of competent jurisdiction; or
c) determined pursuant to the procedures set forth in clause 23.3; |
|
Shareholders Agreement | means the shareholders agreement between the Shareholders and the Company dated 24 August 2016; | |
Shareholder Arrangements | means any advisory, contractual or commercial arrangements relating to the Company (including the existing shareholders agreement relating to the Company) to which any or all of the Sellers and/or any of their Affiliates are a party (excluding any employment agreement or consultancy agreement between those Sellers who are employees or consultants and the Company); | |
Shares | means all of the issued ordinary shares in the capital of the Company from time to time; | |
Shortfall | has the meaning given to it in clause 5.1(a); | |
[***] | has the meaning given to it in clause 6.3; | |
Special Indemnity Claim | means a claim in respect of any of the Special Indemnity Matters and Special Indemnity Claims shall be construed accordingly; | |
Special Indemnity Matter | means [***] and Special Indemnity Matters means [***]; | |
Tax, Taxes or Taxation | means all forms of taxation, duties and withholdings in respect of taxation imposed in the United Kingdom or elsewhere (including National Insurance contributions) and all interest, penalties, charges and fines in respect of any of them; | |
Tax Authority | means HMRC and any other authority, body or official (whether in the United Kingdom or elsewhere) competent to assess, demand, impose, administer or collect Tax or make any decision or ruling on any matter relating to Tax; | |
Tax Warranty | means [***] and Tax Warranties means [***]; | |
Tax Warranty Claim | means a claim in respect of any breach of any of the Tax Warranties; | |
Third Party | has the meaning given to it in the License Agreement; | |
Total Consideration | has the meaning given to it in clause 3.1; | |
Total Contingent Consideration | has the meaning given to it in paragraph 1 of Part A of Schedule 5 (Contingent Consideration); | |
Transaction Costs | means all third party fees, costs, expenses, payments, and expenditures incurred by the Company in connection with the transactions contemplated by this Agreement whether or not billed or accrued (including any fees, costs expenses, payments, and expenditures of legal counsel and accountants, the maximum amount of fees costs, expenses, payments, and expenditures payable to financial advisors, investment bankers and brokers of the Company notwithstanding any contingencies for earnouts, escrows, etc., and any such fees, costs, expenses, payments, and expenditures incurred by the Sellers paid for or to be paid for by the Company); |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Transaction Documents | means this Agreement, the Option Agreement, the License Agreement, the Gamma IP License, the Loan Note Instrument, the Disclosure Letter, the Escrow Agreement and the Gamma Service Agreement; | |
Upfront Consideration | has the meaning given to it in clause 3.2; | |
Warrantor Fundamental Warranties | means [***]; | |
Warrantor Fundamental Warranty Claim | means a claim by the Buyer for breach of a Warrantor Fundamental Warranty; | |
Warrantors | means [***], save that if any such person ceases to be employed or otherwise engaged by F-star GmbH (or any of its Affiliates) in a management position or ceases to own (legally or beneficially) Shares then they shall cease to be a Warrantor and shall be replaced as a Warrantor by the person then performing the role of [***] or, in any case, by such person as the Company, acting reasonably, may nominate in writing provided that such person owns Shares (legally or beneficially), performs a senior management role in the Company and the Buyer consents to the appointment, such consent not to be unreasonably withheld, conditioned or delayed, and a Warrantor means any one of them; and | |
Warranty | means [***] and Warranties means [***]. |
1.2. |
Clause, Schedule and paragraph headings shall not affect the interpretation of this Agreement. |
1.3. |
References to clauses and Schedules are to the clauses and Schedules of this Agreement and references to paragraphs are to paragraphs of the relevant Schedule. |
1.4. |
The Schedules form part of this agreement and shall have effect as if set out in full in the body of this Agreement. Any reference to this agreement includes the Schedules. |
1.5. |
A subsidiary or holding company is to be construed in accordance with section 1159 (and Schedule 6) of the Companies Act and a subsidiary undertaking or parent undertaking is to be construed in accordance with section 1162 (and Schedule 7) of the Companies Act; |
1.6. |
A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality). |
1.7. |
A reference to a party shall include that partys personal representatives, successors and permitted assigns. |
Confidential
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1.8. |
Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular. |
1.9. |
Unless the context otherwise requires, a reference to one gender shall include a reference to the other genders. |
1.10. |
A reference to writing or written includes fax and e-mail (unless otherwise expressly provided in this Agreement). |
1.11. |
The ejusdem generis principle of construction shall not apply to this Agreement. Accordingly, any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms. Where the context permits, other and otherwise are illustrative and shall not limit the sense of the words preceding them. |
1.12. |
A reference to a document in this Agreement in the agreed form is to a document agreed by the parties and initialled by them or on their behalf for identification purposes. |
1.13. |
Where any obligation in this Agreement is expressed to be undertaken or assumed by any party, that obligation is to be construed as requiring the party concerned to exercise all rights and powers of control over the affairs of any other person which it is able to exercise (whether directly or indirectly) in order to secure performance of the obligation. |
1.14. |
References to any English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any other legal concept shall, in respect of any jurisdiction other than England, be deemed to include the legal concept which most nearly approximates in that jurisdiction to the English legal term. |
1.15. |
A reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time. |
1.16. |
References to US$ or $ are references to US dollars, legal tender in the United States, and references to GBP or £ are references to pounds sterling, legal tender in the United Kingdom. |
2. |
SALE AND PURCHASE |
2.1. |
Each Seller severally agrees to sell or procure the sale to the Buyer, and the Buyer agrees to buy, all of such Sellers Relevant Shares together with all rights attaching to those Relevant Shares at Completion, free from any Encumbrance and with full title guarantee. |
2.2. |
Each Seller severally waives all rights of pre-emption, rights of first refusal and any other similar rights or other restrictions on transfer conferred on that Seller by the Companys articles of association or otherwise over any of the Relevant Shares. |
2.3. |
The Buyer shall be responsible for the payment of all stamp duty (and, if applicable, stamp duty reserve tax) on this Agreement and the transfers in respect of the Shares at Completion. |
2.4. |
In the event that the Buyer becomes aware that it or the Escrow Agent will have an obligation to deduct or withhold an amount for or on account of Taxes from any payment made under this Agreement, it shall notify the Sellers Representative in writing as soon as reasonably practicable and the parties shall use their reasonable endeavours to do, to the extent within their power and authority, all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement, treaty or domestic exemption which may apply to eliminate or reduce withholding Taxes and otherwise provide the Sellers such assistance as is reasonably required to obtain a refund of the withheld or similar Taxes, or obtain a credit with respect to such Taxes. In the event there is no applicable double taxation agreement, treaty or domestic exemption or if an applicable double taxation agreement, treaty or domestic exemption reduces but does not eliminate such withholding or similar Tax, the Buyer or Escrow Agent shall deduct the amount paid from the amount due to the respective Seller or Sellers, remit such withholding or similar Tax to the |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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appropriate Tax Authority and secure and send to the respective Seller or Sellers reasonable evidence of the payment of such withholding or similar Tax. In the event that any Taxes are required by applicable Tax law to be withheld or deducted for or on account of Tax from any payments made under this Agreement, any Taxes so withheld and deducted from any payment by the Buyer or the Escrow Agent and paid over to the appropriate Tax Authority shall be treated as paid to the Sellers under this Agreement. |
3. |
CONSIDERATION |
3.1. |
The purchase price for the Shares shall be an amount equal to: |
(a) |
the Upfront Consideration; and |
(b) |
any Contingent Consideration, |
(collectively, the Total Consideration).
Upfront Consideration
3.2. |
The aggregate consideration payable by the Buyer to the Sellers for the Shares pursuant to this Agreement on the Completion Date shall be: |
(a) |
the Initial Amount; plus |
(b) |
the Estimated Net Cash, |
(the amount set out in clause 3.2(a) plus the amount set out in clause 3.2(b) being the Initial Consideration), as increased by the amount to be paid by the Buyer or, as the case may be, decreased by the amount to be paid by the Sellers, pursuant to clause 4.1 (the total sum being referred to as the Upfront Consideration).
3.3. |
At Completion, the Buyer shall pay: |
(a) |
an amount in cash equal to the Initial Consideration less the Escrow Amount, by transfer of funds for same day value to the Payments Administrator in accordance with clause 13.1; and |
(b) |
the Escrow Amount into the Escrow Account by transfer of funds for same day value. |
3.4. |
The parties agree to comply with their respective obligations under Part A of Schedule 4 (Preparation of Completion Accounts). |
Contingent Consideration
3.5. |
If any of the Milestone Events set forth in Schedule 5 (Contingent Consideration) are achieved, the Buyer will make the corresponding Milestone Payment to the Payments Administrator for further distribution to the Sellers on or prior to the Payment Date. Any Contingent Consideration payable to the Sellers shall be allocated between the Sellers with regard to their respective Proportion of Initial Consideration or as otherwise notified to the Buyer in writing by the Sellers Representative at least five (5) Business Days prior to a Payment Date and shall be satisfied: |
(a) |
in respect of the Loan Note Sellers, by the issue by the Buyer of the Contingent Consideration Loan Notes to each of the Loan Note Sellers equal, in principal amount, to the relevant Contingent Consideration due to such Loan Note Sellers; and |
Confidential
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(b) |
in respect of the Cash Sellers, by paying the relevant Contingent Consideration due to each of the Cash Sellers to the Payments Administrator in accordance with clause 13 on a Payment Date. |
3.6. |
Simultaneously with the issue by the Buyer of any Contingent Consideration Loan Notes to the Loan Note Sellers in accordance with clause 3.5(a), the Buyer shall transfer to the Loan Note Escrow Account an amount equal to the total aggregate principal amount of such Contingent Consideration Loan Notes, which amount (together with any interest accrued thereon) shall be released by the Escrow Agent to the Loan Note Sellers within five (5) Business Days following redemption of such Contingent Consideration Loan Notes in accordance with the Loan Note Instrument. The Escrow Agent may withdraw from the Loan Note Escrow Account an amount equal to any Tax on the interest earned in respect of money held in the Loan Note Escrow Account for which it is liable. |
3.7. |
The Total Contingent Consideration shall not under any circumstances exceed the Maximum Contingent Consideration. |
3.8. |
The Buyer shall (and shall procure that all relevant Buyers Group Undertakings shall) comply with the provisions of Schedule 5 (Contingent Consideration). |
3.9. |
The proportion of the Initial Consideration, to which each Seller is entitled is set against his name in column C of Schedule 1 (The Sellers) (each, a Proportion of Initial Consideration). |
Consideration Generally
3.10. |
Each Seller agrees to the allocation of the Total Consideration as provided for in this Agreement (including any allocation notified to the Buyer by the Sellers Representative pursuant to clause 3.5) and waives any claim or dispute regarding the apportionment of the proceeds from the sale of his Shares provided it is made in accordance with this Agreement. Following any payment to the Payments Administrator in accordance with this Agreement, the Buyer shall be under no obligation to see that any such amounts are divided and paid to each Seller (or any other person). |
3.11. |
If, after Completion, any Seller is in or comes into possession of any amounts attributable to any other Seller then as soon as reasonably practicable following any request by the Seller which has the right to such amounts, the relevant Seller shall use all reasonable endeavours to ensure that the person in possession of that relevant amount does or causes to be done all such things as the Seller entitled to such amount may from time to time reasonably require, in order to transfer possession of such relevant amount to the owner. |
4. |
POST COMPLETION ADJUSTMENTS |
4.1. |
If the amount of the Actual Net Cash: |
(a) |
is less than the amount of the Estimated Net Cash, then, subject to clause 5.3, the Sellers shall pay the Buyer an amount equal to the amount of such shortfall (the Shortfall); or |
(b) |
exceeds the amount of the Estimated Net Cash, the Buyer shall pay the Sellers an amount equal to the amount of such excess, |
in either case, together with an amount equal to interest on such sum calculated on a daily basis at a rate of [***] from (and including) the Completion Date to (but excluding) the date of actual payment, in accordance with the provisions of clauses 4.2 and 4.3.
4.2. |
Payments made by the Buyer pursuant to clause 4.1(b) shall be made by transfer of funds for same day value (to the Payments Administrator in accordance with clause 13.1), within two (2) Business Days of the Determination Date without set off, deduction or withholding (except as required by law or by this Agreement). |
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4.3. |
If an amount is payable by the Sellers pursuant to clause 4.1(a), such amount shall be paid from the Escrow Account to the Buyer when the Buyer and the Sellers Representative within two (2) Business Days of the Determination Date jointly instruct the Escrow Agent in writing to make such payment out of amounts standing to the credit of the Escrow Account to the Buyers Account in accordance with clause 13.2. |
5. |
COMPLETION |
5.1. |
Completion shall take place at the offices of the Sellers Solicitors immediately following the execution of this Agreement. |
5.2. |
At Completion each Seller and the Buyer shall do all those things respectively required of each of them in Schedule 3 (Completion Requirements). |
5.3. |
Neither the Sellers nor the Buyer are obliged to complete this Agreement unless: |
(a) |
all of the Sellers (in the case of the Buyer) or the Buyer (in the case of the Sellers) comply with all its/their obligations under this clause 5 and Schedule 3 (Completion Requirements); and |
(b) |
subject to the provisions of clause 7 of the Option Agreement, the purchase of all the Shares under this Agreement is completed simultaneously. |
5.4. |
If Completion does not take place immediately following the execution of this Agreement because the Buyer or any Seller (the Defaulting Party) fails to comply with any of its obligations under this clause 5 and Schedule 3 (Completion Requirements) (whether such failure amounts to a repudiatory breach or not) (a Material Default), the Buyer (if the Defaulting Party is a Seller) or the Company (if the Defaulting Party is the Buyer) (the Non-defaulting Party) may by notice to the Defaulting Party: |
(a) |
proceed to Completion to the extent reasonably practicable (without limiting its rights under this Agreement); |
(b) |
postpone Completion to such date as the Non-defaulting Party may specify; or |
(c) |
terminate this Agreement by notice in writing to the Defaulting Party (a Termination Notice) save that the Non-defaulting Party shall have five (5) Business Days from receipt of the Termination Notice to remedy such Material Default (provided, however, that no such cure period shall be available or applicable to any such Material Default which by its nature cannot be cured). In the event that the Material Default is capable of being remedied but is not so remedied within the requisite time period, this Agreement shall terminate upon expiry of the period of five (5) Business Days without further action by either party. If the Material Default is remedied within the requisite time, the Termination Notice shall lapse and Completion shall be deemed to have been postponed until such date as the Non-defaulting Party may determine. |
5.5. |
If the Non-defaulting Party postpones Completion to another date in accordance with clause 5.4(b), or if Completion is deemed to have been postponed to another date in accordance with clause 5.4(c), the provisions of this Agreement apply as if that other date is the Completion Date. |
5.6. |
If the Non-defaulting Party terminates this Agreement pursuant to clause 5.4(c), each partys further rights and obligations cease immediately on termination, but termination does not affect a partys accrued rights and obligations at the date of termination. |
Confidential
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5.7. |
The parties agree that except in the case of fraud, wilful misconduct or wilful concealment on behalf of the Sellers or the Buyer, rescission shall not be available as a remedy for any breach of this Agreement. |
5.8. |
Nothing in this clause 5 shall prevent a Non-defaulting Party from exercising remedies available to it under applicable law. |
6. |
ESCROW ACCOUNT |
6.1. |
Each party agrees that the money in the Escrow Account shall only be used in accordance with the provisions set out in clause 4, this clause 6, paragraph 5 of Part A of Schedule 4 (Preparation of Completion Accounts) and the Escrow Agreement. |
6.2. |
Each party shall ensure that all rights to the Escrow Account remain free from any Encumbrance, set off or counterclaim except as referred to in this clause 6. |
6.3. |
The liability of any Warrantor in respect of any [***] shall be limited by the amount of money standing to the credit of the Escrow Account from time to time and the sole remedy of the Buyer under this Agreement in respect of a [***] shall be the release of any such amount to the Buyer from the Escrow Account. |
6.4. |
A [***] must be satisfied out of and deducted from the money in the Escrow Account in accordance with this clause 6 and a Shortfall must be first satisfied out of and deducted from the money in the Escrow Account in accordance with this clause 6. In addition, in the event of [***]. |
6.5. |
To the extent that liability for [***] is to be satisfied from the Escrow Account, each Warrantor shall be [***] liable to the Buyer for such liability up to the availability of any amount standing to the credit of the Escrow Account from time to time irrespective of the amount (if any) contributed to the Escrow Account by such Warrantor. |
6.6. |
No Warrantor shall have any liability to any other Seller in respect of any liability satisfied from the Escrow Account. |
6.7. |
Clauses 6.3 and 6.6 shall not apply so as to limit the liability of any Warrantor in respect of any fraud by such Warrantor or any remedy available to any other Seller or the Buyer in respect thereof. |
6.8. |
Interest accruing from time to time on the balance of money standing to the credit of the Escrow Account shall be added to the money standing to the credit of the Escrow Account and shall form part of it for the purposes of this clause 6. |
6.9. |
All of the costs (including reasonable legal costs) and expenses (together with any applicable VAT), in each case, of any nature whatsoever, of the Escrow Agent in relation to the Escrow Account and the Escrow Agreement shall be deemed to be Transaction Costs. |
6.10. |
The Escrow Agent may withdraw from the Escrow Account an amount equal to any Tax on the interest earned in respect of money held in the Escrow Account for which it is liable. |
6.11. |
On the Release Date, the money then standing to the credit of the Escrow Account less the total of the then outstanding Disputed Business Warranty Claims and less any amount that has not yet been paid in accordance with clause 4 or paragraph 5 of Part A of Schedule 4 (Preparation of Completion Accounts) shall be paid to the Payments Administrator in accordance with clause 13.1. After that date, to the extent that the money standing to the credit of the Escrow Account from time to time exceeds the total of the then outstanding Disputed Business Warranty Claims and any amount that has not yet been paid in accordance with clause 4 or paragraph 5 of Part A of Schedule 4 (Preparation of Completion Accounts), that money shall be paid to the Payments Administrator in accordance with clause 13.1. |
Confidential
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6.12. |
If the Sellers or the Buyer are entitled to money from the Escrow Account under clauses 6.4 or 6.11, the Sellers Representative and the Buyer shall within five (5) Business Days of the date on which the entitlement arises jointly instruct the Escrow Agent in writing to release the money to the Payments Administrator in accordance with clause 13.1 or the Buyer, as the case may be, together with an amount (less any Tax and other amount the Escrow Agent is legally required to deduct from that amount) equal to the interest actually accrued on such sum calculated for the period from (and including) the date of this Agreement to (but excluding) the date of payment. |
6.13. |
All payments made to the Buyer by the Escrow Agent under this clause 6 shall be made gross and without deduction or withholding of any kind other than any deduction or withholding required by law. |
6.14. |
The amount, if any, of the Escrow Amount which is paid to the Buyer pursuant to clause 4.2 or this clause 6 shall be treated as a reduction in the Total Consideration. |
6.15. |
The Sellers agree between themselves that any amounts released to the Payments Administrator for further distribution to the Sellers from the Escrow Account shall be apportioned between them by reference to their respective contribution initially made to the Escrow Amount (as set out in column E of the table in Schedule 1 (The Sellers). |
7. |
SELLER WARRANTIES AND INDEMNITY |
7.1. |
Each Seller (i) [***] warrants [***] to the Buyer in the terms of the Fundamental Warranties at Completion and, subject to clause 7.4, the Tax Warranties at Completion; and (ii) subject to the limitations set forth in Schedule 8 (Limitations on the Sellers Liability) agrees [***], and on a pro rata basis in accordance with each Sellers Proportion of Initial Consideration, to indemnify the Buyer against any losses, costs, claims, liabilities, damages, demands and expenses arising out of any Special Indemnity Matter save where such losses, costs, claims, liabilities, damages, demands and/or expenses are a result of any action or omission by or on behalf of the Buyer (or any Buyers Group Undertaking) or due to the Buyers (or any Buyers Group Undertakings) gross negligence, wilful misconduct or wilful concealment. |
7.2. |
Each Warrantor [***] warrants [***] to the Buyer in the terms of the Warrantor Fundamental Warranties at Completion. |
7.3. |
Subject to clause 7.4, each Warrantor [***] warrants to the Buyer on the terms of the Business Warranties at Completion. |
7.4. |
[***] For the avoidance of doubt, [***]. |
7.5. |
[***]. |
7.6. |
Where [***] is qualified by the expression so far as the Warrantors are aware or to the best of the knowledge, information and belief of the Warrantors or qualified by any similar expression, each Warrantor shall be deemed only to have knowledge of anything of which [***]. |
7.7. |
Each Seller agrees and undertakes to the Buyer and to each person referred to in this clause 7.7 that, except in the case of fraud, it will not make any claim against the Company or any director, officer or employee of the Company on whom it may have relied before agreeing any term of this Agreement or any of the transaction contemplated by this Agreement which it may have in respect of a misrepresentation, inaccuracy or omission in or from information or advice provided by any such person for the purpose of |
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assisting any such Seller to make a representation, give a Warranty or prepare the Disclosure Letter (as applicable). After Completion, the Company or any director, officer or employee of the Company may enforce the terms of this clause 7.7 subject to and in accordance with [***]. |
7.8. |
[***]. |
8. |
LIMITATIONS TO THE SELLERS LIABILITY |
8.1. |
Each Sellers liability for [***] and each Warrantors liability for [***] shall be limited or excluded, as the case may be, as set out in clause 7 and Schedule 8 (Limitations on the Sellers Liability). |
8.2. |
Except as stated in this Agreement, the Buyer shall not be restricted from including as part of any Claim any losses, costs, claims, liabilities, damages, demands and/or expenses [***]. |
9. |
BUYERS WARRANTIES |
The Buyer warrants to each Seller as at Completion that:
9.1. |
it is a company duly incorporated and validly existing in the State of Delaware, United States and has the right, power and authority to execute, deliver and perform its obligations under this Agreement and any other Transactional Document to be executed by it; |
9.2. |
the Buyers obligations under this Agreement and any other Transactional Documents to be executed by the Buyer are, or when the relevant document is executed will be, enforceable in accordance with their terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors rights generally and general equitable principles; |
9.3. |
the execution, delivery and performance by the Buyer of this Agreement and each Transactional Document to be executed by it will not breach any provision of the certificate of incorporation or bylaws of the Buyer or breach any applicable laws or regulations, or any orders, judgements or decrees which the Buyer is bound by or result in a breach of or constitute a default under any instrument, contract or agreement to which the Buyer is a party or by which the Buyer is bound and which, in each case, is material in the context of the transactions contemplated by this Agreement and any of the Transactional Documents; and |
9.4. |
it has available on an unconditional basis (subject only to Completion) the necessary resources to meet its obligations under this Agreement, other than payment of the Contingent Consideration. |
10. |
POST COMPLETION MATTERS |
10.1. |
Each Seller agrees in respect only of itself that the Seller shall, for so long as the Seller remains the registered holder of any of the Relevant Shares after Completion, hold those Relevant Shares with all rights and benefits attaching or accruing to them on or after the date of this Agreement as bare trustee for the Buyer absolutely. |
10.2. |
For a period of [***] after Completion each Seller hereby irrevocably undertakes to the Buyer pending registration by the Company of the transfer of the Sellers Relevant Shares to the Buyer, to exercise any votes attaching to any of the Sellers Relevant Shares or sign any consent to short notice of a general meeting (or written resolution in lieu thereof) as the Buyer may reasonably direct. |
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10.3. |
Each Seller acting severally shall execute and shall procure the execution of, all documents and deeds and/or do or procure the doing of, all acts and things that the Buyer reasonably requires after Completion to vest in the Buyer legal title to and the full benefit of the Relevant Shares held by such Seller. |
10.4. |
Subject to clause 10.5, each of the Sellers (for itself and for and on behalf of each of its Affiliates) hereby irrevocably agrees that, with effect from and conditional upon Completion: |
(a) |
the Shareholder Arrangements are hereby terminated; |
(b) |
any and all rights of any Seller and/or any of its Affiliates and any and all obligations of the Company under, pursuant to or in connection with the Shareholder Arrangements, along with any other claim or demand of any Seller or any of its Affiliates against the Company, which are subsisting or outstanding at the date of this Agreement are expressly waived and released, including any and all such rights and obligations, claims and demands which may have accrued in respect of any period prior to Completion; and |
(c) |
any and all other debts or liabilities (whether actual, contingent or prospective and including any interest thereon) of the Company to any Seller under, pursuant to or in connection with the Shareholder Arrangements or otherwise which are subsisting or outstanding at the date of this Agreement are expressly waived, released and discharged. |
10.5. |
Each Seller shall ensure that at Completion there will be no amounts owing by the Company to such Seller in respect of itself and its Affiliates only, other than by way of accrued but unpaid salary or consultancy fees or unreimbursed expenses incurred in the ordinary course of business consistent with past practice owed to employees or consultants of the Company. |
10.6. |
The Buyer shall, within 20 Business Days of Completion, procure that the name of the Company is changed to such name as the Buyer may decide provided that it does not include the word F-star. |
10.7. |
The Buyer intends to make an election under Section 338(g) of the United States Internal Revenue Code of 1986, as amended (the IRC) (and any corresponding election under state and local Tax law) with respect to the purchase of the Shares under this Agreement (collectively, the Section 338 Election). The Buyer may make the Section 338 Election in its sole discretion; provided, however, that the Sellers shall not be liable in respect of a Tax Warranty Claim for any liability of the Company for Taxes arising directly or indirectly from the Section 338 Election and the Buyer shall indemnify the Sellers and the Company on an after-Tax basis against any Tax liability, losses and all reasonable costs and expenses of the Sellers or the Company which arise directly or indirectly as a result of the Section 338 Election being made excluding any Tax liability, losses or costs and expenses that would have not have arisen had all of the Tax Warranties made by the Company and Sellers been true, correct and complete. In addition, in the case of any Seller, the calculation of any increase in Tax liability of such Seller resulting from the Section 338 Election shall be made assuming (a) that such Seller and any of its direct or indirect owners has made a timely and valid election under Section 1295 of the U.S. Internal Revenue Code of 1986, as amended (the Code) and the regulations thereunder to treat its shares in the Company as a qualified electing fund within the meaning of Section 1295 effective with the first day of such Sellers holding period in the Companys shares and (b) that the Company is not, and has not at any time during the five (5) taxable years preceding the Completion Date, been a controlled foreign corporation within the meaning of Section 957 of the IRC. For clarify, Purchaser shall not be required under this Section 10.7 to indemnify the Company or any Seller for any Tax liability that would not have arisen had a Seller (or its direct or indirect owners) elected to treat the Company as a qualified electing fund and/or had the Company not been a controlled foreign corporation, as described in the previous sentence. |
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11. |
BUYER GUARANTEE |
11.1. |
Following Completion, the Buyer guarantees to F-star, whenever the Company does not pay any of the Guaranteed Obligations when due, to pay within 5 Business Days following receipt of written demand from F-star, the Guaranteed Obligations. |
11.2. |
Following Completion, the Buyer as principal obligor and as a separate and independent obligation and liability from its obligations and liabilities under clause 11.1 agrees to indemnify and keep indemnified F-star in full and on written demand from and against all and any losses, costs, claims, liabilities, damages, demands and expenses suffered or incurred by F-star arising directly out of the Guaranteed Obligations not being recoverable for any reason or any failure of the Company to pay any of its obligations or liabilities in respect of the Guaranteed Obligations. |
11.3. |
This guarantee is and shall cover the ultimate balance from time to time owing to F-star by the Company in respect of the Guaranteed Obligations. |
11.4. |
The liability of the Buyer under this clause 11 shall not be terminated by: |
(a) |
any intermediate payment, settlement of account or discharge in part of the Guaranteed Obligations; |
(b) |
any variation, extension, discharge, compromise, dealing with, exchange or renewal of any right or remedy which F-star may now or after the date of this guarantee have from or against any of the Company and any other person in connection with the Guaranteed Obligations; |
(c) |
any amendment, variation, novation, replacement or supplement of or to any of the Guaranteed Obligations; |
(d) |
any grant of time, indulgence, waiver or concession to the Company or any other person; |
(e) |
any insolvency, bankruptcy, liquidation, administration, winding up, incapacity, limitation, disability, the discharge by operation of law, or any change in the constitution, name or style of the Company, F-star, or any other person; |
(f) |
any claim or enforcement of payment from the Company or any other person; or |
(g) |
any act or omission which would not have discharged or affected the liability of the Buyer had it been a principal debtor instead of a guarantor, or indemnifier or by anything done or omitted by any person which, but for this provision, might operate to exonerate or discharge the Buyer or otherwise reduce or extinguish its liability under this guarantee. |
11.5. |
Any release, discharge or settlement between the Buyer and F-star in relation to this guarantee shall be conditional on no right, disposition or payment to F-star by the Buyer, the Company or any other person in respect of the Guaranteed Obligations being avoided, set aside or ordered to be refunded under any enactment or law relating to breach of duty by any person, bankruptcy, liquidation, administration, protection from creditors generally or insolvency or for any other reason. |
11.6. |
If any right, disposition or payment referred to in clause 11.5 is avoided, set aside or ordered to be refunded, F-star shall be entitled subsequently to enforce this guarantee against the Buyer as if such release, discharge or settlement had not occurred and any such right, security, disposition or payment had not been given or made. |
11.7. |
F-star shall be entitled to enforce this clause 11 against the Buyer as if it were a party to this Agreement. |
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12. SELLERS REPRESENTATIVE
12.1. |
Each Seller hereby irrevocably and unconditionally appoints the Sellers Representative as sole representative agent and attorney-in-fact to act on such Sellers behalf for all purposes relating to this Agreement after Completion and each agreement and document ancillary thereto, including for the purposes of: |
(a) |
accepting and giving notices on behalf of such Seller; |
(b) |
making elections and granting any consent or approval on behalf of such Seller under this Agreement; |
(c) |
approving and executing any document on behalf of such Seller to give effect to the release of any money then standing to the credit of the Escrow Account; |
(d) |
defending, negotiating, compromising, settling and releasing on behalf of such Seller any rights and claims (including legal proceedings) which the Buyer may threaten or pursue in respect of any breach of, or right under, this Agreement or any other Transactional Document; |
(e) |
confirming the allocation between the Sellers of the Contingent Consideration to be made under this Agreement; |
(f) |
enforcing, negotiating, compromising, settling and releasing on behalf of such Seller any rights and claims (including legal proceedings and ADR) which he may have, threaten or pursue against the Buyer (or any other person) in respect of any breach of, or right under, this Agreement or any other Transactional Document or any Dispute; |
(g) |
consent or agree to any amendment to this Agreement or to waive any terms and conditions of this Agreement providing rights or benefits to the Sellers (other than with respect to the payment of the Total Consideration) in accordance with the terms hereof and in the manner provided herein; |
(h) |
taking any and all actions that may be necessary or desirable in connection with the payment by the Sellers of the costs and expenses incurred under this Agreement; and |
(i) |
generally taking any and all other actions and doing any and all other things provided in or contemplated by this Agreement and each agreement and document ancillary thereto to be performed by such Seller or the Sellers Representative. |
12.2. |
Each Seller hereby irrevocably (by way of security for the performance of his obligations under this Agreement) appoints the Sellers Representative as its agent with full authority on his behalf and in the Sellers name, as applicable, or otherwise, to do all acts and to execute and deliver such documents or deeds as are required by law or as may, in the reasonable opinion of the Sellers Representative, be required or convenient to give effect to the matters described in clause 12.1. |
12.3. |
The Sellers Representative shall act in good faith in accordance with what the Sellers Representative believes to be the best interests of the Sellers when exercising any power or authority conferred on under this clause 12. |
12.4. |
Save in the event of fraud, any action undertaken or omitted by the Sellers Representative with the written approval of a Sellers Majority shall be conclusively deemed to be in accordance with the requirements of clause 12.3 provided that, for the avoidance of doubt, such approval shall not be necessary. |
12.5. |
The Sellers Representative may resign at any time. The Sellers Representative may consult with any Seller to the extent a claim is threatened or pursued by the Buyer in respect of any breach of, or right under, this Agreement or any other Transactional Document and which specifically concerns any actual or alleged act or default of that Seller. |
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12.6. |
The Sellers may, by written notice signed by a Sellers Majority (a Change Of Sellers Representative Notice), replace a resigning Sellers Representative or remove an incumbent Sellers Representative from such position and appoint another person to act as Sellers Representative in substitution thereof (a New Sellers Representative). A Change Of Sellers Representative Notice shall be effective only once a copy thereof has been served on both the incumbent Sellers Representative and the Buyer. |
12.7. |
A New Sellers Representative so appointed shall, with effect from the time of its appointment, execute a deed of adherence in favour of the Sellers and the Buyer pursuant to which it shall agree to adhere to, and be bound by, this Agreement as though named herein as the Sellers Representative and the parties agree that such substitute New Sellers Representative shall be conferred the rights, power and authorities (including as set out in this clause 12) of the Sellers Representative as set out in this Agreement and entitled to directly enforce the same (notwithstanding that it may not have initially been a signatory hereto). A copy of such deed of adherence shall be delivered to the Buyer at the same time as the Change Of Sellers Representative Notice is served thereon under clause 12.6. |
12.8. |
If at any time a New Sellers Representative is appointed in accordance with clause 12.6, if required by the Buyer, the Sellers Representative hereby undertakes to do all such things as may be necessary to novate the Escrow Agreement from the previous Sellers Representative to the New Sellers Representative. |
12.9. |
Any action taken or any exercise of powers under this Agreement by the Sellers Representative or any New Sellers Representative shall be binding on each Seller for the purposes of this Agreement, shall be deemed to be done by each Seller, and the Buyer shall be entitled to assume that any action taken by the Sellers Representative or any New Sellers Representative whose appointment has been notified in accordance with this clause 14 is binding on all of the Sellers and the parties shall be entitled to rely on the same. The Buyer shall not be required to make further enquiries in respect thereof. The Buyer shall have no obligation to monitor or supervise the Sellers Representative or any New Sellers Representative. The Buyer shall not be liable to any of the Sellers for any action taken or omitted to be taken by the Sellers Representative or any New Sellers Representative. |
12.10. |
All costs (including legal costs) and expenses (including Tax), in each case, of any nature whatsoever, of the Sellers Representative shall be borne by the Sellers in the proportions set out in column C of the table in Schedule 1 (The Sellers). |
12.11. |
The Sellers Representative shall have no liability or obligation to take any action on behalf of any Seller under the powers and authorities conferred on the Sellers Representative by this Agreement where such action may result in the Sellers Representative incurring any cost, expense or liability unless the Sellers Representative is satisfied with any arrangements made by (or on behalf of) the Sellers for the satisfaction or re-imbursement of such costs, expenses and liabilities. |
12.12. |
Upon Completion, and subject to receipt by the Sellers Representative of the cash sum provided for in clause 3.3(a), the Sellers Representative will retain an amount of [***] from such sum (the Expense Fund), which will be used for the purposes of paying directly, or reimbursing the Sellers Representative for, any third party expenses pursuant to this Agreement and the transactions contemplated hereby. The Sellers will not receive any interest or earnings on the Expense Fund and irrevocably transfer and assign to the Sellers Representative any ownership right that they may otherwise have had in any such interest or earnings. The Sellers Representative will not be liable for any loss of principal of the Expense Fund other than as a result of its gross negligence or wilful misconduct. The Sellers Representative will hold these funds separate from its corporate funds in a segregated client account, will not use these funds for its operating expenses or any other corporate purposes and will not voluntarily make these funds available to |
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its creditors in the event of bankruptcy. As soon as practicable following the completion of the Sellers Representatives responsibilities, the Sellers Representative will distribute the balance of the Expense Fund to the Payments Administrator for further distribution to the Sellers. For tax purposes, the Expense Fund shall be treated as having been received and voluntarily set aside by the Sellers at the time of Completion. The parties agree that the Sellers Representative is not responsible for any tax withholding or reporting or acting as a withholding agent or in any similar capacity in connection with the Expense Fund. |
12.13. |
The Sellers Representative will incur no liability of any kind with respect to any action or omission by the Sellers Representative in connection with Sellers Representatives services pursuant to this Agreement and any agreements ancillary hereto, except in the event of liability directly resulting from the Sellers Representatives gross negligence or wilful misconduct. The Sellers Representative shall not be liable to any Seller as a result of any action or omission that is taken (or not taken) in good faith pursuant to the advice of external legal counsel in the proper performance of its obligations under this Agreement. The Sellers will, severally and not jointly, on a pro rata basis equal to the portion of Total Consideration each such Seller is entitled to receive pursuant to this Agreement compared to the aggregate Total Consideration entitled to be received by all Sellers, indemnify, defend and hold harmless the Sellers Representative from and against any and all losses, liabilities, damages, claims, penalties, fines, forfeitures, actions, fees, costs and expenses (including the fees and expenses of counsel and experts and their staffs and all expense of document location, duplication and shipment) (collectively, Representative Losses) arising out of or in connection with the Sellers Representatives execution and performance of this Agreement and any agreements ancillary hereto, in each case as such Representative Loss is suffered or incurred; provided, that in the event that any such Representative Loss is finally adjudicated to have been directly caused by the gross negligence or wilful misconduct of the Sellers Representative, the Sellers Representative will reimburse the Sellers the amount of such Representative Loss to the extent attributable to such gross negligence or wilful misconduct. If not paid directly to the Sellers Representative by the Sellers, any such indemnified Representative Losses may be recovered by the Sellers Representative from (i) the funds in the Expense Fund, (ii) the amounts in the Escrow Amount at such time as remaining amounts would otherwise be distributable to the Sellers, and (iii) from any Milestone Payments at such time as any such amounts would otherwise be distributable to the Sellers; provided, that while this section allows the Sellers Representative to be paid from the Expense Fund, the Escrow Amount and the Milestone Payments, this does not relieve the Sellers from their obligation to promptly pay such Representative Losses as they are suffered or incurred, nor does it prevent the Sellers Representative from seeking any remedies available to it at law or otherwise. In no event will the Sellers Representative be required to advance its own funds on behalf of the Sellers or otherwise. For the avoidance of doubt and notwithstanding anything in this Agreement to the contrary, the limitations on liability of the Sellers set forth elsewhere in this Agreement are not intended to be applicable to the indemnities provide to the Sellers Representative under this clause 12.13. The Sellers acknowledge and agree that the foregoing indemnities will survive the resignation or removal of the Sellers Representative or the termination of this Agreement. |
13. |
PAYMENTS |
13.1. |
Payments to be made to the Sellers under this Agreement shall be made in US dollars by telegraphic transfer of immediately available funds to such account controlled by the Payments Administrator as may be notified by the Payments Administrator or the Sellers Representative in writing to the Buyer. |
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13.2. |
Payments to be made to the Buyer under this Agreement shall be made in US dollars by telegraphic transfer of immediately available funds to such account as may be notified in writing by the Buyer to the Payments Administrator. |
13.3. |
The payment of any sum to the Buyer by or on behalf of any of the Sellers will discharge the obligations of the Sellers to pay the sum in question and the Sellers shall not be concerned to see the application of the monies so paid. |
13.4. |
The payment of any sum to the Payments Administrator by or on behalf of the Buyer will discharge the obligations of the Buyer to pay the sum in question and the Buyer shall not be concerned to see the application of the monies so paid. |
14. |
ANNOUNCEMENTS |
14.1. |
Subject to clause 14.2, no party (the disclosing party) may, before or after Completion, make or issue a public announcement or press release concerning the transactions referred to in this Agreement other than the Press Release unless it has first obtained the written consent of the Sellers (prior to Completion, if the disclosing party is the Buyer) or the Sellers Representative (after Completion, if the disclosing party is the Buyer), or of the Buyer (if the disclosing party is a Seller) (in either case, the other party), which consent may not be unreasonably withheld or delayed. |
14.2. |
Clause 14.1 does not apply to a public announcement or press release required by law, by a rule of a listing authority by which a partys shares are listed, a stock exchange on which a partys shares are listed or traded or by a governmental authority or other authority with relevant powers to which either party is subject or submits, whether or not the requirement has the force of law, provided that the public announcement, communication or circular shall so far as is practicable be made after consultation with the other party and after taking into account the reasonable requirements of the other party as to its timing, content and manner of making or despatch. |
15. |
CONFIDENTIALITY |
15.1. |
Subject to clause 15.4, each party shall treat the following information as confidential to the extent obtained as a result of or in connection with entering into this Agreement: |
(a) |
details of the provisions of this Agreement, the Transactional Documents and any other agreement or arrangement entered into in connection with this Agreement; |
(b) |
information relating to the negotiations leading to the execution of this Agreement, the Transactional Documents and any other agreement or arrangement entered into in connection with this Agreement; and |
(c) |
(to the extent obtained as a result of or in connection with entering into this Agreement) information relating to the other party or such partys group undertakings, |
provided that the parties shall always be permitted to confirm that the transaction effected by this Agreement has taken place without providing any further information.
15.2. |
Any party may disclose information otherwise required by clause 15.1 to be treated as confidential: |
(a) |
if and to the extent required by the laws of any relevant jurisdiction, provided that the disclosing party shall, where it is practicable to do so and where permitted under applicable law, notify the other party of such disclosure in writing and take reasonable steps to minimize the extent of any such required disclosure; |
(b) |
if and to the extent requested by any competent regulatory or governmental body, Tax Authority or securities exchange in any relevant jurisdiction wherever situated, whether or not the request has the force of law and including for the avoidance of doubt, any disclosure required by US accounting regulations; |
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(c) |
to a Tax Authority in connection with the Tax affairs of the disclosing party; |
(d) |
to its professional advisers, auditors or bankers from time to time provided that such disclosure is reasonably required; |
(e) |
to its shareholders and/or its limited partners as appropriate; |
(f) |
in the case of the Buyer, to members of the Buyers Group and to their professional advisers, auditors or bankers in each case from time to time; |
(g) |
if and to the extent the information is or comes into the public domain through no fault of that part of any of those to whom that party has disclosed information; or |
(h) |
if and to the extent, in the case of a Seller, the Buyer or, in the case of the Buyer, the Sellers Representative, has given prior written consent to the disclosure. |
15.3. |
Each party shall ensure that any person to whom confidential information is disclosed pursuant to clauses 15.2(d) through 15.2(f) is made aware of the obligations of confidentiality contained in this clause and agrees to adhere to them. |
15.4. |
Notwithstanding anything in this Agreement to the contrary, following Completion, the Sellers Representative shall be permitted to: (i) after the public announcement (if any) of the transaction contemplated by this Agreement, publicly announce that it has been engaged to serve as the Sellers Representative in connection with the transaction as long as such announcement does not disclose any of the other terms hereof and (ii) disclose information to the Sellers who have a need to know such information provided that any such information will be subject to the confidentiality provisions of this Agreement including clause 15.1. |
16. |
COSTS |
Except where this Agreement or the relevant document provides otherwise, each party shall pay its own costs relating to the negotiation, preparation, execution and performance by it of this Agreement and of each document referred to in it.
17. |
GENERAL |
17.1. |
A variation of this Agreement is valid only if it is in writing and signed by or on behalf of each party, provided that after Completion, any variation may be signed by the Sellers Representative on behalf of itself and the Sellers provided the Sellers Representative has the prior written approval of the Sellers Majority. The parties to this Agreement do not require the consent of any person having a right under the Contracts (Rights of Third Parties) Act 1999, as provided in clause 17.7, to rescind or vary this agreement. |
17.2. |
The failure to exercise or delay in exercising a right or remedy provided by this Agreement or by law does not impair or constitute a waiver of the right or remedy or an impairment of or a waiver of other rights or remedies. No single or partial exercise of a right or remedy provided by this Agreement or by law prevents further exercise of the right or remedy or the exercise of another right or remedy. |
17.3. |
The Buyers rights and remedies contained in this Agreement are cumulative and not exclusive of rights or remedies provided by law to the extent not excluded or limited by this Agreement. |
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17.4. |
Except to the extent that they have been performed and except where this Agreement provides otherwise, the obligations contained in this Agreement remain in force after Completion. |
17.5. |
Any payment by a Seller, pursuant to a Fundamental Warranty Claim, Special Indemnity Claim or Tax Warranty Claim or a Warrantor, pursuant to a Warrantor Fundamental Warranty Claim or a Business Warranty Claim shall, to the extent possible and without limiting the liability of any Seller or Warrantor (as the case may be) under this Agreement, be treated as a reduction in the purchase price payable by the Buyer for the Shares. |
17.6. |
All payments made by a Seller under this Agreement shall be made gross, free of right of counterclaim or set off and without deduction or withholding of any kind other than deductions or withholding required by law. |
17.7. |
Except as provided in clauses 10.7 and 11.7, a person who is not a party to this Agreement has no right, including under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement. |
18. |
ENTIRE AGREEMENT |
18.1. |
The Transactional Documents constitute the entire agreement between the parties. They supersede any previous agreements relating to the subject matter of the Transactional Documents, and set out the complete legal relationship of the parties arising from or connected with that subject matter. |
18.2. |
Nothing in this clause 19 shall have the effect of limiting any liability arising from fraud or wilful non-disclosure. |
19. |
ASSIGNMENT |
19.1. |
Subject to clause 19.2, no right or obligation arising under this Agreement or any other Transactional Document may be assigned, transferred or otherwise disposed of, in whole or in part without the prior written agreement if the assignor is the Buyer, of the Sellers Representative, or if the assignor is a Seller, of the Buyer. |
19.2. |
The Buyer shall be entitled to assign any benefit arising under or out of this Agreement or any other Transactional Document to any Buyers Group Undertaking provided that the Buyer enters into a guarantee in a form reasonably satisfactory to the Sellers Representative and further provided that, if the assignee is to cease to be a Buyers Group Undertaking it shall, before ceasing to be so, assign the benefit (so far as it is assigned) to another Buyers Group Undertaking. |
19.3. |
The Buyer agrees that if it makes an assignment pursuant to this clause 19, the assignment shall not increase the liabilities of any Seller. |
20. |
NOTICES |
20.1. |
A notice or other communication under or in connection with this Agreement (a Notice) shall be: |
(a) |
in writing; |
(b) |
in the English language; and |
(c) |
delivered personally or sent by first class post (and air mail if overseas) or fax or email to the party due to receive the Notice to the address set out in clause 20.3 or to an alternative address, person or fax number or email address specified by that party by not less than five Business Days written notice to the other party received before the Notice was despatched. |
20.2. |
Unless there is evidence that it was received earlier, a Notice is deemed given if: |
(a) |
delivered personally, when left at the address referred to in clause 20.3; |
(b) |
sent by mail, except air mail, two Business Days after posting it; |
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(c) |
sent by air mail, six Business Days after posting it; and |
(d) |
sent by email, when the email is sent, provided that a copy of the Notice is sent by another method referred to in this clause 20.2 on the same Business Day as the sending of the email, and provided further that the sender of the email does not receive an automated response from the recipient or a mail server indicating that the recipient is out of office or that the email could not be delivered. |
20.3. |
The address referred to in clause 23.1.3 is: |
Name of Party | Address |
Email address or telephone number |
For the attention of | |||
Each Seller | In relation to each Seller, the address set out adjacent to that Sellers name in column A of Schedule 1 (The Sellers). | |||||
Sellers Representative |
Shareholder Representative Services LLC 1614 15th Street, Suite 200, Denver, CO 80202, United States |
deals@srsacquiom.com | Managing Director | |||
The Buyer |
201 Gateway Boulevard South San Francisco California United States |
[***] |
Nick Galli and Alexander Schuth |
21. |
COUNTERPARTS |
This Agreement may be executed in any number of counterparts, each of which when executed and delivered is an original and all of which together evidence the same agreement.
22. |
GOVERNING LAW |
This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.
23. |
DISPUTE RESOLUTION |
23.1. |
If a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute), it shall be resolved pursuant to this clause 23. |
23.2. |
General |
Any Dispute shall first be referred to the Chief Executive Officer of the Buyer and the Sellers Representative, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by such persons shall be conclusive and binding on the parties to this Agreement. If such persons are not able to agree on the resolution of any such
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issue within thirty (30) days (or such other period of time as mutually agreed by the Buyer and the Sellers Representative) after such issue was first referred to them, then either the Buyer or the Sellers Representative may, by written notice to the other, elect to initiate an alternative dispute resolution (ADR) proceeding pursuant to the procedures set forth in clause 23.3 for purposes of having the matter settled.
23.3. |
ADR |
Any ADR proceeding under this Agreement (with the exception of that specified in paragraph 11 of Schedule 8) shall take place pursuant to the procedures set forth in clause 15.7.3 of the License Agreement, save that references to Denali are references to the Buyer and references to the Licensor are references to the Sellers (or relevant Seller).
23.4. |
Interim Relief |
Notwithstanding anything herein to the contrary, nothing in this clause 23 shall preclude either party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute following the ADR procedures set forth in clause 23.3, if necessary to protect the interests of such party. This clause shall be specifically enforceable.
23.5. |
RIGHTS OF EACH PARTY/NON-WAIVER |
The rights of each party under this Agreement:
(a) |
may be exercised as often as necessary; |
(b) |
except as otherwise expressly provided in this Agreement, are cumulative and not exclusive of rights and remedies provided by law; and |
(c) |
may be waived only in writing and specifically. |
24. |
PROCESS AGENTS |
The Buyer irrevocably appoints [***] as its process agent to receive on its behalf service of process in any proceedings [***]. Service upon the process agent shall constitute good and valid service on the Buyer whether or not the process is forwarded to or received by the Buyer. If for any reason the process agent ceases to act as process agent, resigns [***], the Buyer irrevocably agrees to appoint a substitute process agent [***] acceptable to the Sellers Representative and to deliver to the Sellers Representative a copy of the substitute process agents acceptance of that appointment within 10 Business Days of the obligation to appoint arising. In the event that the Buyer fails to appoint a substitute process agent, it shall be effective service for the Sellers (or the Sellers Representative) to serve process upon the last known address [***] of the last known process agent for the Buyer notified to the Sellers, notwithstanding that such process agent is no longer found at such address or has ceased to act.
25. |
CONFLICT WAIVER |
Notwithstanding that the Company has been represented by Cooley (UK) LLP (the Firm) in the preparation, negotiation and execution of this Agreement and the transactions contemplated hereby, the Company agrees that after Completion the Firm may represent the Sellers Representative, the Sellers and/or their Affiliates in matters related to this Agreement and the transactions contemplated hereby, including without limitation in respect of any indemnification claims pursuant to this Agreement and the transactions contemplated hereby. The Company hereby acknowledges, on behalf of itself and its Affiliates, that it has had an opportunity to ask for and has obtained information relevant to such representation, including disclosure of the reasonably foreseeable adverse consequences of such representation, and it hereby waives any conflict arising out of such future representation.
IT WITNESS whereof this Agreement has been entered into as a deed and is delivered on the date first aforementioned.
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SCHEDULE 1
The Sellers
(A) |
(B) | (C) | (D) | (E) | ||||
Name and Address of Seller |
No. of Ordinary Shares |
Proportion of Initial
Consideration (%) |
Contribution to Expense
Fund (US$) |
Contribution to Escrow
Account (%) |
||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] |
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SCHEDULE 2
Information about the Company
Registered Number: | 10214672 | |
Place of Incorporation: | England and Wales | |
Address of Registered Office: |
Eddeva B920 Babraham Research Campus Cambridge CB22 3AT |
|
Type of Company: | Private company limited by shares | |
Total Issued Share Capital: | £90.39625 comprising 9,039,625 ordinary shares with an aggregate nominal value of £0.00001 with £0.00001 paid up on each share | |
Directors: |
John Edwards Jean-Francois Formela Deborah Harland Tolga Hassan John Haurum Patrick Krol Florian Ruker Helmut Schuehsler |
|
Secretary: | Tolga Hassan | |
Accounting Reference Date: | 31 December | |
Subsidiaries: | None |
SCHEDULE 3
Completion Requirements
1. |
Sellers Obligations |
1.1. |
At Completion, each Seller shall deliver the following documents or items to the Buyer or at the Buyers direction: |
1.1.1. |
duly executed transfer(s) in respect of that Sellers Relevant Shares to the Buyer or its nominee(s) and the share certificate(s) for such Relevant Shares; |
1.1.2. |
duly executed powers of attorney or other authorities in the agreed form under which this Agreement, the other Transactional Documents and the transfers referred to in paragraph 1.1.1 of this Schedule 3 have been or are to be executed by such Seller; and |
1.1.3. |
(if the Buyer so requires) an irrevocable power of attorney in the agreed form duly executed by such Seller and any other registered owner of such Sellers Relevant Shares in favour of the Buyer or its nominee(s) generally in respect of the Relevant Shares. |
1.2. |
At Completion the Sellers shall deliver, procure delivery or make available to the Buyer: |
1.2.1. |
each register, minute book and other book required by law to be kept by the Company made up to the Completion Date and each certificate of incorporation and certificate(s) of incorporation on change of name for the Company; |
1.2.2. |
(if the Buyer so requires) resignations in the agreed form from each director and secretary of the Company expressed to take effect from the end of the meeting held pursuant to paragraph 1.3; |
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1.2.3. |
the Management Accounts; |
1.2.4. |
a copy of each bank mandate of the Company and copies of statements of each bank account of the Company made up to a date not earlier than two (2) Business Days before the Completion Date; |
1.2.5. |
a counterpart of the Escrow Agreement duly executed by the Sellers Representative; and |
1.2.6. |
the Disclosure Letter signed on behalf of each Warrantor. |
1.3. |
The Sellers shall ensure that at Completion a meeting of the board of directors of the Company is held at which the directors: |
1.3.1. |
vote in favour of the registration of the Buyer or its nominee(s) as member(s) of the Company in respect of the Shares (subject to the production of properly stamped transfers); and |
1.3.2. |
approve the payment of the Transaction Costs. |
2. |
Buyers Obligations |
2.1. |
At Completion, the Buyer shall deliver to the Sellers: |
2.1.1. |
a counterpart of the Escrow Agreement duly executed by the Buyer; and |
2.1.2. |
a counterpart of the Disclosure Letter signed by the Buyer. |
2.2. |
At Completion, the Buyer shall procure that the Company shall pay the Transaction Costs to the extent not already paid. |
SCHEDULE 4
Completion Accounts
Part A: Preparation of Completion Accounts
1. |
The Buyer shall procure that Draft Completion Accounts are prepared in accordance with the provisions of this Part A of Schedule 4 and on the basis of the Accounting Policies. |
2. |
The Draft Completion Accounts shall be delivered to the Sellers Representative by the Buyer as soon as is reasonably practicable and, in any event, not later than 90 calendar days after Completion. |
3. |
If the Sellers Representative does not within 30 calendar days of presentation to it of the Draft Completion Accounts give notice to the Buyer that it disagrees with the Draft Completion Accounts or any item therein, stating the reasons for the disagreement in reasonable detail including each disputed item, the amount in dispute and the basis for such dispute (the Sellers Disagreement Notice), the Draft Completion Accounts shall constitute the Completion Accounts and shall be final and binding on the parties for all purposes in accordance with paragraph 12 of this Part A of Schedule 4. |
4. |
If the Sellers Representative gives a Sellers Disagreement Notice under paragraph 3, the Buyer and the Sellers Representative shall attempt in good faith to reach agreement in respect thereof (and, if such agreement is reached, the Draft Completion Accounts as amended by the matters set out in the Sellers Disagreement Notice and agreed by the Buyer and the Sellers Representative in writing shall constitute the Completion Accounts and shall be final and binding on them for all purposes in accordance with |
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paragraph 12 of this Part A of Schedule 4). If they are unable to do so within 30 calendar days of such notification under paragraph 3 of this Part A of Schedule 4, either party may, by notice to the other (an Appointment Notice), require that the Draft Completion Accounts be referred to an independent firm of internationally recognised chartered accountants agreed upon by the Buyer and the Sellers Representative or, failing agreement within five (5) Business Days of service of the Appointment Notice, nominated by the President for the time being of the Institute of Chartered Accountants in England and Wales or in his/her absence a suitable deputy (the Reporting Accountants). |
5. |
The Reporting Accountants shall be engaged jointly by the Buyer and the Sellers (acting through the Sellers Representative) and the charges (including any VAT) of the Reporting Accountants shall be allocated between the Buyer on the one hand and the Sellers (acting through the Sellers Representative) on the other by the Reporting Accountants in proportion to the extent either of such parties did not prevail in the aggregate on the disputed items (as measured by the amounts in dispute). If any amount is payable by the Sellers pursuant to this paragraph 5, such amount shall be paid from the Escrow Account when the Buyer and the Sellers Representative shall within three (3) Business Days following the date of such election or within five (5) Business Days of the Determination Date (whichever is later) jointly instruct the Escrow Agent in writing to make such payment out of amounts standing to the credit of the Escrow Account. |
6. |
Except to the extent that the Buyer and the Sellers Representative agree otherwise, the Reporting Accountants shall determine their own procedure but each party shall use all reasonable endeavours to procure that the Reporting Accountants apply the following rules: |
6.1. |
apart from procedural matters and as otherwise set out in this Agreement, they shall determine only: |
6.1.1. |
whether any of the arguments for an alteration to the Draft Completion Accounts put forward in respect of matters specified in the Sellers Disagreement Notice is correct in whole or in part (unless such matters have been agreed between the Sellers Representative and the Buyer); and |
6.1.2. |
if so, what alterations (if any) should be made to the Draft Completion Accounts; |
6.2. |
they shall apply the Accounting Policies; |
6.3. |
they shall make their determination pursuant to paragraph 6.1 of this Part A of Schedule 4 as soon as is reasonably practicable; |
6.4. |
the procedure of the Reporting Accountants shall: |
6.4.1. |
give the Buyer and the Sellers Representative a reasonable opportunity to make oral representations and representations in writing to them; |
6.4.2. |
require that each party supplies the other with a copy of any representations in writing at the same time as they are made to the Reporting Accountants; and |
6.4.3. |
permit each party to be present while oral submissions are being made by the other party; |
6.5. |
for the avoidance of doubt, the Reporting Accountants shall not be entitled to determine the scope of their own jurisdiction; and |
6.6. |
the determination of the Reporting Accountants pursuant to paragraph 6.1 of this Part A of Schedule 4 shall be made in writing. |
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7. |
The Reporting Accountants shall act as experts and not as arbitrators and their determination of any matter falling within their jurisdiction shall be final and binding on the parties, save in the event of fraud of the Buyer, any of the Sellers or the Reporting Accountants or manifest error of the Reporting Accountants (when the relevant part of their determination shall be void). In particular, without limitation, their determination shall be deemed to be incorporated into the Draft Completion Accounts, which shall then be final and binding on the parties for the purposes of this Schedule 4, save as stated above in the event of fraud or manifest error. |
8. |
The Buyer and the Sellers Representative shall co-operate with the Reporting Accountants and comply with their reasonable requests made in connection with the carrying out of their duties pursuant to their engagement under the terms of this Agreement. |
9. |
Subject to paragraph 10 of this Part A of Schedule 4, nothing in this Schedule 4 shall entitle the Buyer or the Sellers Representative or the Reporting Accountants to have access to any information or document which is protected by legal professional privilege, or which has been prepared by the other party or its accountants or other professional advisers with a view to assessing the merits of any claim or argument. |
10. |
The Buyer and the Sellers Representative shall not be entitled by reason of paragraph 9 of this Part A of Schedule 4 to refuse to supply such part or parts of documents as contain only the facts on which the relevant claim or argument is based. |
11. |
Each party and the Reporting Accountants shall, and shall procure that its accountants and other advisers shall, keep all information and documents provided to them pursuant to this Part A of Schedule 4 confidential and shall not use them for any purpose, except for disclosure or use in connection with the preparation of the Draft Completion Accounts and the agreement or determination of the Completion Accounts, the proceedings of the Reporting Accountants or any other matter arising out of this Agreement or in defending any claim or argument or alleged claim or argument relating to this Agreement or its subject matter. |
12. |
When the Sellers Representative and the Buyer reach agreement on the Draft Completion Accounts or when the Draft Completion Accounts is finally determined at any stage in accordance with the procedures set out in this Part A of Schedule 4: |
12.1. |
the Draft Completion Accounts as so agreed or determined shall constitute the Completion Accounts for the purposes of this Agreement and shall (in the absence of fraud or manifest error) be final and binding on the parties; and |
12.2. |
the Actual Net Cash shall be the amount set out in line item E in the Completion Accounts. |
13. |
Subject to paragraph 9 of this Part A of Schedule 4 and clause 15 of the Agreement, each Seller shall (in relation to information in its possession or control only) and the Buyer shall procure that the Company shall (in relation to information in their respective possession or control), promptly provide the parties, their respective advisers, the Buyers accountants and the Sellers accountants and, if relevant, the Reporting Accountants with all information (in their respective possession or control) relating to the operations of the Company, as the case may be, including access at all reasonable times to the Company and the employees of the Company (who shall give such explanations as any party may reasonably require in relation to the preparation of the Draft Completion Accounts), books, records, and other relevant information and all cooperation and assistance, as in any such case be reasonably required to enable the production and agreement or determination of the Completion Accounts pursuant to and in accordance with this Part A of Schedule 4; provided however, that the auditors or accountants of the Buyer or the Company shall not be obliged to make any work papers available to any person unless and until such person has signed a customary agreement relating to access to such work papers in form and substance reasonably acceptable to the Buyer and such auditors or accountants. |
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14. |
The Sellers (acting through the Sellers Representative) and the Buyer shall each bear their own costs (including legal costs) and expenses (including tax) together with VAT charged thereon, arising out of the preparation and review of the Draft Completion Accounts and the agreement or determination of the Completion Accounts. |
Part B: Completion Accounts
[***] | ||||
[***] | ||||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] |
Part C: Accounting Policies
1. |
General Accounting Policies |
1.1. |
The Completion Accounts shall be determined in accordance with the following: |
(a) |
first, in accordance with the [***]; |
(b) |
secondly, and to the extent not covered by or inconsistent with paragraph 1.1(a) of this Part C of Schedule 4 (which shall prevail in the event of any inconsistency), on a basis consistent with [***]; and |
(c) |
thirdly, and to the extent not covered by or inconsistent with paragraphs 1.1(a) or 1.1(b) of this Part C of Schedule 4 (which shall prevail in the event of any inconsistency), [***]. |
1.2. |
The parties acknowledge that the sole purpose of determining the Actual Net Cash is to determine the adjustments (if any) to be made to the Initial Consideration in accordance with clause 3. |
1.3. |
The provisions of this Part C of Schedule 4 and the line items comprising the Completion Accounts shall be interpreted so as to avoid double counting (whether positive or negative) of any items to be included in the Actual Net Cash. |
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Part D: Preparation of Management Accounts
1. |
ACCOUNTING POLICIES |
a. |
PRESENTATION OF MANAGEMENT ACCOUNTS |
CRITICAL ACCOUNTING JUDGMENTS AND KEY SOURCES OF ESTIMATION UNCERTAINTY
In the application of the Companys accounting policies, management make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period of the revision and future periods if the revision affects both current and future periods.
b. |
OVERALL CONSIDERATIONS |
The principal accounting policies adopted in the preparation of the management accounts are set out below.
i. |
BASIS OF PREPARATION OF MANAGEMENT ACCOUNTS |
These management accounts have been prepared in accordance with EU endorsed International Financial Reporting Standards (IFRS) and interpretations issued by the IFRS Interpretations Committee (IFRS IC) and the Companies Act 2006 applicable to companies reporting under IFRS. The management accounts have been prepared under the historical cost convention.
ii. |
GOING CONCERN |
Management prepare management accounts on a going concern basis unless they intend to liquidate the business or to cease trading, or have no realistic alternative but to do so. In deciding whether the going concern basis is appropriate, the directors examine existing budgets and forecasts, assess borrowing requirements, and review other information as needed.
iii. |
NEW AND AMENDED STANDARDS ADOPTED BY THE COMPANY |
In any period, new or amended standards and interpretations are considered for adoption. Other standards, amendments and interpretations which are effective for the period are considered where they material to the Company.
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c. |
RECEIVABLES |
Receivables are recognised initially at fair value less provision for impairment. The Company provides an allowance for uncollectible accounts based on prior experience and managements assessment of the collectability of existing specific accounts.
d. |
CASH AND CASH EQUIVALENTS |
Cash and cash equivalents comprises cash on hand and demand deposits, and other short-term and highly liquid investments with original maturities of three months or less that are readily convertible to a known amount of cash and are subject to an insignificant risk of changes in value.
e. |
EQUITY AND RESERVES |
Ordinary and preferred shares are classified as equity. Issued capital represents the nominal value of shares that have been issued. Retained earnings includes all current period retained profits and accumulated losses.
f. |
TRADE PAYABLES |
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Trade and other payables are stated at cost, which approximates fair value due to the short term nature of these liabilities. Trade payables are classified as current liabilities if payment is due within one period or less. If not, they are presented as non-current liabilities.
g. |
REVENUE RECOGNITION |
Revenue is measured at the fair value of the consideration received or receivable and is stated net of value added taxes. Revenue is recognised when it is probable that future economic benefits will flow to the Company and those benefits can be measured reliably. Revenue on the sale of an asset (e.g. the outright sale or assignment of a licence) is only recognised when, inter alia, the significant risks and rewards of ownership have been transferred to the buyer and the Company does not retain either control of the goods, or continuing involvement, to the degree associated with ownership.
Where, as part of a licence agreement, services are performed by an indeterminate number of acts over a specified period of time, revenue for such services is recognised on a straight-line basis over the specified period unless there is evidence that some other method represents better the stage of completion.
h. |
SHARE BASED PAYMENTS |
A share option compensation charge is not recognised in the monthly management accounts.
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i. |
TAXATION AND DEFERRED TAX |
A tax credit or charge is not reflected in the monthly management accounts.
Deferred tax is not reflected in the monthly management accounts.
j. |
FINANCIAL INSTRUMENTS |
i. |
FINANCIAL ASSETS |
All financial assets relate to trade and other receivables, which are stated at their recoverable amount, which approximates the fair value due to the short term nature of these assets.
ii. |
RISK MANAGEMENT POLICY |
The Company undertakes transactions denominated in foreign currencies and as such is exposed to currency risk due to fluctuations in foreign exchange rates. The Company does not use derivative instruments to reduce exposure to foreign exchange risk.
iii. |
FINANCIAL LIABILITIES |
Trade and other payables are stated at cost. This approximates fair value due to the short term nature of these liabilities.
k. |
FOREIGN CURRENCY TRANSLATION |
Foreign currency transactions are translated at the rates of exchange in effect at the dates of the transaction. Resulting foreign currency denominated monetary assets and liabilities are translated at the rates of exchange in effect at the balance sheet date. Gains and losses on foreign exchange are recognised in the income statement.
SCHEDULE 5
Contingent Consideration
Part A: Contingent Consideration
1. |
Definitions |
In this Schedule 5, and where applicable, the remainder of this Agreement, the following definitions shall apply:
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Accepted Fcab Target has the meaning given to it in the License Agreement, with respect to events and circumstances before Completion and has the meaning given to it in the Gamma IP License with respect to events and circumstances after Completion;
Commercialisation has the meaning given to it in the License Agreement;
Commercially Reasonable Efforts has the meaning given to it in the License Agreement;
Conforming mAb2 means [***];
Contingent Consideration means any of the Milestone Payments;
Default Notice has the meaning given to it in paragraph 2.2 of this Part A of Schedule 5;
Denali Fcab has the meaning given to it in the License Agreement;
EU Regulatory Milestone means [***];
European Union or E.U. has the meaning given to it in the License Agreement and shall be deemed to include [***];
Fcab Delivery means, with respect to an Accepted Fcab Target, that an Fcab that specifically binds to such Accepted Fcab Target has achieved Fcab Delivery (as defined therein) under Section 4.3 or Section 9.11.1 of the License Agreement or Section 4.1.2 of the Gamma Services Agreement during the applicable Fcab Disclosure Period (as defined therein);
First Commercial Sale has the meaning given to it in the License Agreement, except that all references to Licensed Products in such definition will be read as references to mAb2 Products;
Fcab has the meaning given to it in the License Agreement;
Fcab Disclosure Period has the meaning given to it in the License Agreement;
GMP has the meaning given to it in the License Agreement;
Initial Milestone has the meaning given to it in the table in Part B of this Schedule 5;
Initial Payment True Up Event means that [***];
Joint Fcab has the meaning given to it in the License Agreement;
Licensor Fcab has the meaning given to it in the License Agreement;
mAb2 Product means [***];
Major EU Market means each of [***].
Milestone Event means the relevant event as set out in column 1 of Part B of this Schedule 5, which shall trigger the relevant Milestone Payment. In addition:
a) |
where [***], it shall be considered a Milestone Event in respect of which the Buyer will pay to the Sellers a one-time payment (which shall constitute a Milestone Payment) of [***]; and |
b) |
if [***], then such achievement will be considered a Milestone Event and the Buyer will make a payment (which shall constitute a Milestone Payment) equal to [***] of the amount that would have been payable to the Company in respect of such event under Section 9.6.1 of the License Agreement, had the License Agreement remained in effect following Completion; provided, for clarity, that if [***]; |
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c) |
if [***], then such achievement will be considered a Milestone Event and the Buyer will make a payment (which shall constitute a Milestone Payment) equal to [***]of the amount that would have been payable to the Company in respect of such event under Section 9.6.2 of the License Agreement, had the License Agreement remained in effect following Completion; provided, however, that if the [***], then the Milestone Payment required in connection with such Milestone Event shall be reduced by [***]; provided, further, for clarity, that if [***]; |
d) |
[***]; |
Milestone Payment means, with respect to a Milestone Event:
a) |
if [***], a payment equal to [***] of the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event; and |
b) |
if [***], a payment equal to [***] of the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event; |
In no event will more than one Milestone Payment be made for a given Milestone Event, regardless of how many mAb2 Products achieve such Milestone Event, except that [***], then a second Milestone Payment shall become due with respect to such Milestone Event, in an amount equal to [***] of the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event. For clarity, under no circumstances will the total Milestone Payments that the Buyer becomes obligated to make in respect to a given Milestone Event exceed the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event;
Net Sales means, with respect to a mAb2 Product for any period, the total amount billed or invoices on sales of such mAb2 Product during such period by the Buyer, its Affiliates or sublicensees, calculated in accordance with the definition of Net Sales used in the License Agreement, and reading all references to Licensed Products in such definition as references to mAb2 Products;
Non-conforming mAb2 means a mAb2 Product that is not a Conforming mAb2;
Payment Date means the date which is 90 calendar days after any date on which a Milestone Payment is triggered;
Regulatory Approval has the meaning given to it in the License Agreement;
Relevant Period means the period from Completion until [***];
Remaining Amount means the aggregate Contingent Consideration payable pursuant to [***] minus the aggregate Contingent Consideration actually paid by the Buyer pursuant to [***] prior to the date of delivery of a Default Notice;
Risk-Adjusted Remaining Amount means [***];
Confidential
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-132-
Total Contingent Consideration means the aggregate of the Milestone Payments; and
US Regulatory Milestone means [***].
2. |
Conduct of business during Relevant Period |
Commercially Reasonable Efforts
2.1. |
The Buyer shall during the Relevant Period use Commercially Reasonable Efforts to achieve both of the EU Regulatory Milestone and the US Regulatory Milestone. The Sellers acknowledge and agree that, in addition to the foregoing: |
(a) |
the Buyer shall be deemed to have satisfied its obligations under this paragraph 2.1 of Schedule 5 so long as the Buyer is using Commercially Reasonable Efforts to advance [***] toward achievement of the [***]; |
(b) |
the Buyer shall have the right to satisfy its diligence obligations under this paragraph 2.1 of Schedule 5 through its Affiliates or Sublicensees; and |
(c) |
nothing in this paragraph 2.1 of Schedule 5 is intended, or shall be construed, to require the Buyer to Develop: |
(i) |
[***]; or |
(ii) |
[***]. |
2.2. |
If at any time the Sellers have a reasonable basis to believe that the Buyer is in material breach of its obligations under paragraph 2.1 of Schedule 5 and such material breach has continued for a period of at least [***] (a Continuing Material Breach), then the Sellers shall cause the Sellers Representative to deliver written notice (the Default Notice) of such Continuing Material Breach to the Buyer and, if the Buyer fails to remedy such Continuing Material Breach within 60 days of receipt of the Default Notice, then the provisions of paragraph 2.3 shall apply. |
2.3. |
If the Buyer is in Continuing Material Breach of its obligations under paragraph 2.1 and following receipt of a Default Notice fails to remedy such Continuing Material Breach within the time period set out in paragraph 2.2, then the Sellers Representative may, by written notice to the Buyer, elect to initiate an ADR proceeding pursuant to the procedures set forth in clause 23.3, and the arbitrators for such ADR proceeding shall be instructed and required to conduct a proceeding for the sole purposes of [***]. In the event [***] the Buyer is in Continuing Material Breach of its obligations under paragraph 2.1, the Buyer shall pay to the Sellers [***] the Risk-Adjusted Remaining Amount. |
2.4. |
Any amount to be paid by the Buyer pursuant to paragraph 2.3: |
(a) |
to the Cash Sellers, shall be paid by transfer of the relevant funds for same day value to the Payments Administrator, |
(b) |
to the Loan Note Sellers, shall be paid by the issue by the Buyer of Contingent Consideration Loan Notes to each of the Loan Note Sellers equal, in principal amount, to the relevant amount due to each of them pursuant to paragraph 2.3, |
in each case shall be made within 30 Business Days of the expiry of the time period set out in paragraph 2.2 without set off, deduction or withholding (except as required by law or by this Agreement).
2.5. |
The Sellers agree between themselves that any payments to the Payments Administrator pursuant to paragraph 2.4 shall be apportioned, and the principal amount of any Contingent Consideration Loan Notes |
Confidential
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133
issued pursuant to paragraph 2.4 shall be calculated, by reference to the Sellers respective Proportion of Initial Consideration. The Buyer shall not be responsible for how any such payment to the Payments Administrator is allocated or applied by the Payments Administrator. |
2.6. |
A payment or issue of Contingent Consideration Loan Notes by the Buyer pursuant to paragraph 2.3 shall not discharge the Buyer of its obligation to pay any further Contingent Consideration (if any) above the amounts paid to the Sellers in accordance with paragraph 2.3 upon achievement of the relevant Milestone Events. |
2.7. |
The parties acknowledge that: |
(a) |
any provision in this Agreement that imposes a detriment on a party in breach, in particular as set out in paragraph 2.3 of this Part A of Schedule 5, represents a genuine pre-estimate of the loss expected to be suffered by the party not in breach, and: |
(i) |
protects the legitimate interests of the other parties in the enforcement of the obligation breached; and |
(ii) |
is not out of all proportion to those legitimate interests; and |
(b) |
they are of comparable bargaining power and each of them has been properly advised in relation to this Agreement. |
Record Keeping and Reporting
2.8. |
The Buyer agrees that during the period whilst further Contingent Consideration is payable in accordance with this Schedule 5 it shall, and shall procure that each other Buyers Group Undertaking shall: |
(a) |
prepare and maintain reasonably complete and accurate records regarding any Commercialisation or Development efforts which relate to any mAb2 Product and all other data necessary for the calculation of the Contingent Consideration; |
(b) |
once per calendar year, on 31 January, and subject to reasonable procedures and agreements to preserve confidentiality, provide the Sellers Representative with a written report on material developments with respect to the Development and Commercialisation of any mAb2 Product, together with such reasonable additional information regarding any such activities or events as the Sellers Representative may reasonably request from time to time (subject to any applicable third party confidentiality restrictions) which shall include copies of relevant documents as requested by the Sellers Representative; and |
(c) |
once per calendar year during the Relevant Period, within 30 days of the Sellers Representatives written request, meet in person or by telephone with the Sellers Representative. At such meetings, the Buyer shall cause senior officers from the research, clinical development, and business operations of the Buyer and/or the Buyers Group Undertakings to attend, to present and to answer questions. Each of the Buyer and the Sellers Representative (on behalf of the Sellers) shall bear its own costs and expenses regarding such meetings. |
2.9. |
Upon receipt of a request from the Sellers Representative, the Buyer shall, and shall ensure each of Buyers Group Undertakings shall, permit an independent auditor designated by the Sellers Representative |
Confidential
134
to inspect and audit the records and books of account maintained by it pursuant to paragraph 2.8 in order to confirm the accuracy and completeness of such records and books of account and the calculation of the Contingent Consideration. Any such audit shall (i) be for a reasonable duration during office hours on a Business Day; (ii) be upon notice of at least 30 days; and (iii) not be requested more than once during each financial year of the period during which any Contingent Consideration remains payable. The Sellers Representative (on behalf of the Sellers) shall pay the costs of each audit unless the audit reveals a variance of more than [***] between the amounts paid and the amounts due, in which case the Buyer shall bear the cost of the audit, provided, however, that in the event the audit pertains to achievement of a Milestone Event relating to the Buyers Net Sales, the Sellers Representative (on behalf of the Sellers) shall pay the costs of each audit unless the audit reveals a variance of more than [***] between the Net Sales reported by Buyer and the Net Sales determined by the audit. If the audit reveals an underpayment by the Buyer, the Buyer shall transfer the amount by which it had underpaid by transfer of funds for same day value to the Payments Administrator for further distribution to the Sellers within 10 Business Days after the date on which such audit is completed. |
Part B: Milestone Payment Amounts
Column 1: Milestone Event |
Column 2: Maximum Milestone
Payment (US$) |
|||
[***] |
[*** | ] | ||
[***] |
[*** | ] | ||
[***] |
[*** | ] | ||
[***] |
[*** | ] | ||
[***] |
[*** | ] | ||
[***] |
[*** | ] | ||
[***] |
[*** | ] | ||
TOTAL = |
[*** | ] |
* |
The maximum Milestone Payment for this Milestone Event shall be increased by [***]. |
SCHEDULE 6
[***]
Part A: [***]
1. |
CAPACITY AND AUTHORITY |
1.1. |
The Seller has the right, power and authority to execute, deliver and perform its obligations under this Agreement and any other Transactional Document to be executed by the Seller and, where the Seller is not an individual, all such obligations of the Seller have been duly and validly approved and authorized by all necessary action on the part of such Seller, and no other action on the part of such Seller is required in connection therewith. |
Confidential
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1.2. |
If such Seller is not an individual, it has been duly incorporated and is validly existing and in good standing under the laws of the jurisdiction in which it is incorporated or constituted (to the extent that such concepts are recognised in such jurisdiction). |
1.3. |
The Sellers obligations under this Agreement and any other Transactional Document to be executed by the Seller are, or when the relevant document is executed will be, enforceable in accordance with their terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors rights generally and general equitable principles |
1.4. |
The execution and delivery of, and the performance by the Seller of its obligations under, this Agreement and any of the Transactional Documents will not: |
(a) |
if relevant, result in a breach of any provision of its articles of association or by-laws; |
(b) |
result in a breach of, or constitute a default under, any instrument to which the Seller is a party or by which the Seller is bound where such breach may prejudice the transactions contemplated by this Agreement or any of the Transaction Documents; or |
(c) |
result in a breach of any order, judgment or decree of any court or Authority to which the Seller is a party or by which the Seller is bound or submits where such breach may prejudice the transactions contemplated by this Agreement or any of the Transaction Documents. |
2. |
SHARES |
2.1. |
The Sellers Relevant Shares constitute the whole of the Sellers interest in the allotted and issued share capital of the Company and the Seller does not exercise voting power over any other outstanding shares or other equity interests of the Company. |
2.2. |
The Seller is entitled to sell and transfer or procure the transfer of the full legal and beneficial ownership of its Relevant Shares to the Buyer on the terms set out in this Agreement. |
2.3. |
The Shares registered in the name of the Seller and set out opposite his name at column B of Schedule 1 have been properly allotted and issued and are fully paid and such Shares will be sold free of all Encumbrances and there is no agreement, arrangement or obligation to give or create any such Encumbrance. No person has claimed to be entitled to an Encumbrance in relation to any such Shares. |
Part B: [***]
1. |
SHARES |
1.1. |
At Completion, the Shares are registered in the name of the Sellers and set out opposite their names at column B of Schedule 1 and constitute the entire issued share capital of the Company, have been properly allotted and issued and are fully paid or credited as fully paid. |
1.2. |
Other than this Agreement, the Transaction Documents, the Shareholders Agreement or as referred to or contemplated by this Agreement, there is no agreement, arrangement or obligation requiring the creation, allotment, issue, transfer, redemption or repayment of, or the grant to a person by the Company of the right (conditional or not) to require the allotment, issue, transfer, redemption or repayment of, a share in the capital of the Company (including an option or right of pre emption or conversion). |
Confidential
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136
1.3. |
So far as the Warrantors are aware, no person has claimed to be entitled to an Encumbrance in relation to any Shares. |
1.4. |
Save for this Agreement, the Transaction Documents, the Companys articles of association and the Shareholders Agreement, there are no contracts relating to voting, purchase, sale or transfer of any Shares (i) between or among the Company and any Shareholder, and (ii) so far as the Warrantors are aware, between or among any of the Shareholders. |
2. |
THE GROUP |
2.1. |
The Company does not have, and has not at any time had, any subsidiary undertakings. |
2.2. |
Other than as contemplated by this Agreement, the Company has no interest in, and has not agreed to acquire an interest in or merge or consolidate with, a corporate body or any other person. |
2.3. |
The information contained in Schedule 1 (The Sellers) and Schedule 2 (Information about the Company) is true and accurate. |
SCHEDULE 7
[***]
1. |
ORGANIZATION |
1.1 |
The Company is a company duly incorporated and validly existing under the laws of England and Wales and has the right, power and authority to execute, deliver and perform its obligations under this Agreement and any other Transactional Document to be executed by it. |
1.2 |
The Companys obligations under this Agreement and any other Transactional Documents to be executed by the Company are, or when the relevant document is executed will be, enforceable in accordance with their terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors rights generally and general equitable principles. |
2. |
ACCOUNTS |
2.1 |
General |
2.1.1 |
The Accounts have been prepared and audited on a proper and consistent basis in accordance with the law and applicable standards, principles and practices generally accepted in the United Kingdom. |
2.1.2 |
The Accounts show a true and fair view of the state of affairs of the Company as at the Last Accounting Date and of the profit or loss of the Company for the financial year ended on the Last Accounting Date. |
2.1.3 |
Save as disclosed in the Accounts, the Accounts have been prepared using the same accounting policies as those adopted and applied in preparing the accounts for the previous two years. |
2.1.4 |
The Company does not have any liabilities of any nature other than (i) those set forth or adequately provided for in the Accounts, (ii) those incurred in the conduct of the Companys business since the Last Accounting Date in the ordinary course, and which, individually or in the aggregate, are not material in nature or amount and do not result from any breach by the Company of any contract, warranty, infringement, tort or violation of law to which it is subject, and (iii) those incurred by the Company in connection with the execution of this Agreement. |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
137
Except for liabilities reflected in the Accounts, the Company has no off balance sheet liability of any nature to, or any material financial interest in, any third party or entities, the purpose or effect of which is to defer, postpone, reduce or otherwise avoid or adjust the recording of expenses incurred by the Company. Without limiting the generality of the foregoing, the Company has never guaranteed any debt or other obligation of any other person.
2.2 |
Provision for Tax |
The Accounts include provision or reserve (as appropriate) in accordance with the relevant accounting standards for Tax liable to be assessed on the Company or for which the Company is accountable in respect of profits earned, accrued or received on or before the Last Accounting Date, and in respect of any event occurring on or before the Last Accounting Date.
2.3 |
Accounting records |
The Companys accounting records are up-to-date in all material respects, are in its possession or under its control and are properly completed in accordance with the law and applicable standards, principles and practices generally accepted in the United Kingdom.
3. |
CHANGES SINCE THE LAST ACCOUNTING DATE |
3.1 |
Since the Last Accounting Date: |
3.1.1 |
the Companys business has in all material respects been operated in the usual way so as to maintain it as a going concern; |
3.1.2 |
there has been no material adverse change in the financial or trading position of the Company or the properties, assets (including intangible assets), liabilities, business, prospects, capitalization, employees, operations or results of operations of the Company or any change that would reasonably be expected to materially impede or delay the Companys ability to consummate the transactions contemplated by this Agreement, other than any event, circumstance or change resulting from changes in stock markets, interest rates, exchange rates, commodity prices or other general economic conditions or changes in conditions affecting the industry generally in which the Company operates; |
3.1.3 |
the Company has not made or entered into any contract or letter of intent with respect to, or otherwise effected, any acquisition, sale, license, disposition or transfer of any asset that is material to the business of the Company, including without limitation, Intellectual Property other than IP Licenses Out; |
3.1.4 |
there has not occurred any change in accounting methods or practices (including any change in depreciation or amortization policies or rates or revenue recognition policies or establishment of reserves) by the Company or any revaluation by the Company of any of its assets; |
3.1.5 |
there has not occurred any declaration, setting aside, or payment of a dividend or other distribution with respect to any securities of the Company, or any redemption, purchase or other acquisition by the Company of any of its securities, or any change in any rights, preferences, privileges or restrictions of any of its outstanding securities; |
Confidential
***Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
138
3.1.6 |
the Company has not entered into, amended, renewed or terminated any Material Contract (as hereinafter defined), and there has not occurred any material default or breach under any Material Contract to which the Company is a party or by which it is, or any of its assets and properties are, bound; |
3.1.7 |
the Company has not incurred, created or assumed any Encumbrance on any of its assets or properties, any material indebtedness, or any liability as guarantor or surety with respect to the obligations of any other person; and |
3.1.8 |
the Company has not paid or discharged any Encumbrance or liability which was not shown on the Accounts or incurred in the ordinary course of business consistent with past practice since the Last Accounting Date. |
4. |
TAX |
4.1 |
The Company has, within the last three years, where legally obliged to do so: |
4.1.1 |
duly and punctually paid all Tax which it has become liable to pay, whether or not shown or required to be shown on any Tax return; |
4.1.2 |
duly deducted, withheld or collected for payment (as appropriate) all Tax due to have been deducted, withheld or collected for payment and has accounted for or paid all such Tax to the relevant Tax Authority (to the extent due); and |
4.1.3 |
not been liable to pay any material interest, penalty or surcharge in respect of any unpaid Tax. |
4.2 |
All returns, computations, information, accounts and notices which are or have been required by law to be made or given by the Company within the last three years for any Tax purposes have been made or given in the required form and have been properly submitted by the Company and are complete and accurate in all material respects. |
4.3 |
The Company has, in the last three years, in all material respects, complied at all times with all statutory requirements, regulations, notices, orders, directions and conditions relating to all relevant Taxes, including the terms of any agreement made with HMRC or any other relevant Tax Authority. |
4.4 |
The Company is not, nor has it at any time within the last three years, been involved in any dispute with or non-routine investigation, audit or discovery by any Tax Authority and, so far as the Warrantors are aware, no such dispute, investigation, audit or discovery is planned. |
4.5 |
There are no liens or encumbrances against any of the Companys assets, arising in connection with a failure to pay any Tax. |
4.6 |
In the last three years, each related party transaction involving the Company is and has been at arms-length in all material respects and determined in compliance in all material respects with applicable transfer pricing rules and regulations. |
4.7 |
The Company does not have any outstanding waivers or extension of the statute of limitations for assessment of any Tax. |
4.8 |
The Company is not a party to, or bound by, any Tax indemnity agreement, Tax sharing agreement or Tax allocation agreement with respect to Taxes (other than any agreement entered into in the ordinary course of business and not primarily related to Taxes) and other than this Agreement, the Spin-Out License, and the License Agreement and any other agreement contemplated by any such agreements. The Company is not liable for Taxes of any other Person (i) under any applicable Law, (ii) as a transferee of any assets or successor to any liabilities, or (iii) by Contract, indemnity or otherwise, including by reason of the transactions contemplated by the Gamma IP License. |
Confidential
139
4.9 |
In the last three years, no written claim has been made by any Tax Authority in a jurisdiction where the Company does not file Tax Returns that the Company is or may be subject to Taxation by that jurisdiction. |
4.10 |
The Company will not, after the Completion Date, be liable under any applicable Law, by Contract, indemnity or otherwise as a transferee of any assets or successor to any liabilities, for any Taxes of F-star, F-star GmbH, or any of their Affiliates as a result of (i) the Companys entry into, and transactions contemplated by, the Gamma IP License, the License Agreement and the Services Agreement and/or (ii) the transactions contemplated by the Option Agreement and this Agreement other than VAT as provided for in any agreement. |
5. |
ASSETS |
5.1 |
Title and condition |
5.1.1 |
Each asset included in the Accounts or acquired by the Company since the Last Accounting Date is: |
(a) |
legally and beneficially owned solely by the Company; |
(b) |
where capable of possession, in the possession or under the control of the Company. |
5.1.2 |
Company owns or has the right to use each asset used in and necessary for the effective operation of its business. |
6. |
INTELLECTUAL PROPERTY |
The Company owns, or has rights to use, all Intellectual Property materially necessary for the Company to operate its business.
6.1 |
Registered Owned IP |
6.1.1 |
The Disclosure Letter sets out details of all material registered Intellectual Property owned by the Company (Registered Owned IP). The Company solely owns the Registered Owned IP. |
6.1.2 |
To the best of the knowledge, information and belief of the Warrantors, (i) there are no issued patents or registered trademarks within the Registered Owned IP that are invalid or unenforceable and (ii) there are no patent applications included within the Registered Owned IP that have not been duly filed and diligently prosecuted. |
6.1.3 |
The Company has received an assignment of rights from each inventor listed in the patents and patent applications included in the Disclosure Letter save in the case of those inventors which are employees of the Company and whose inventions vest in the Company by virtue of their employment relationship. The Company is the sole legal and beneficial owner of each of the patents and patent applications. |
6.1.4 |
All issuance, renewal and maintenance fees due up to and including the date of this Agreement in respect of each of the Registered Owned IP have been paid in full and on time. |
6.2 |
No infringement by Company of third party Intellectual Property |
6.2.1 |
To the best of the knowledge, information and belief of the Warrantors, the activities of the Company, and the practice of the inventions claimed under the Registered Owned IP, do not nor have they in the year prior to the date of this Agreement infringed, misappropriated, misused, violated or otherwise made use without authorisation of any third party Intellectual Property nor has any person threatened to the Company in writing to issue such a notice. |
6.2.2 |
To the best of the knowledge, information and belief of the Warrantors, the Company has not issued any opposition, invalidation, revocation or cancellation proceeding or any other proceeding or counterclaim (including any litigation, arbitration or proceeding pursuant to any other dispute resolution mechanism) concerning the validity, enforceability or title to any Intellectual Property of any third party. |
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140
6.3 |
IP Licenses In and IP Licenses Out |
6.3.1 |
Copies of all material licenses of Intellectual Property granted by the Company (IP Licenses Out) and granted to the Company (IP Licenses In) are included in the Disclosure Bundle. |
6.3.2 |
To the best of the knowledge, information and belief of the Warrantors, no IP License In or IP License Out is currently being, or has at any time been, breached in a material way by the Company or to the best of the Warrantors knowledge, information and belief, by any other party thereto. So far as the Warrantors are aware, the rights granted under the IP Licenses In and IP Licenses Out will not be adversely affected by the transactions contemplated by this Agreement. |
6.3.3 |
To the best of the knowledge, information and belief of the Warrantors, all fees, royalties or other amounts due to be paid by or to the Company in respect of any IP License In or IP License Out have been paid in a timely manner and no such payments have been outstanding for more than 60 days. |
6.4 |
Company Confidential Information |
6.4.1 |
To the best of the knowledge, information and belief of the Warrantors, all Company Confidential Information held by the Company is accurately and properly documented to enable the Buyer to acquire and retain its full benefit and is subject to appropriate storage and security measures to preserve the confidentiality and secrecy of such Company Confidential Information. |
6.4.2 |
To the best of the knowledge, information and belief of the Warrantors, the Company has not disclosed any Company Confidential Information to any person other than (i) its employees and advisors who are bound by obligations of confidence (howsoever arising); (ii) in circumstances where such disclosures have been made in the ordinary course of business; and (iii) pursuant to the IP Licenses Out and the IP Licenses In. |
7. |
INSURANCE |
7.1 |
Policies |
The Disclosure Letter sets out a list of insurance policies maintained by or on behalf of the Company (together the Policies);
7.2 |
Status of the Policies |
Each of the Policies is valid and enforceable and the Warrantors are not aware of any circumstances that would render any of them void or voidable.
7.3 |
Premiums |
All premiums which are due under the Policies have been paid.
8. |
MATERIAL CONTRACTS |
8.1 |
Validity of Material Contract |
Confidential
141
8.1.1 |
Save for the Transaction Documents. the Company is not a party to or bound by any of the following contracts (each a Material Contract): |
(c) |
any contract limiting the freedom of the Company to engage or participate, or compete with any other person, in any line of business, market or geographic area, or to make use of any Intellectual Property, or any contract granting exclusive rights, rights of refusal, rights of first negotiation or similar rights and/or terms to any person, or any contract otherwise limiting the right of the Company to sell, distribute or manufacture any products or services or to purchase or otherwise obtain any products or services; |
(d) |
any licenses, sublicenses and other contracts pursuant to which any person is granted any rights to Intellectual Property of the Company or pursuant to which the Company has agreed to any restriction on the right of the Company to use or enforce any Intellectual Property owned by the Company or pursuant to which the Company agrees to encumber, transfer or sell rights in or with respect to any Intellectual Property owned by the Company; or |
(e) |
any other contract or obligation that individually had or has a value or payment obligation in excess of US$50,000 over the life of the contract or is otherwise material to the Company or its businesses, operations, financial condition, properties or assets. |
8.1.2 |
Each of the Material Contracts is in full force and effect, subject only to the effect, if any, of applicable bankruptcy and other similar laws affecting the rights of creditors generally and rules of law governing specific performance, injunctive relief and other equitable remedies. |
8.1.3 |
No party to a Material Contract has given notice of its intention to terminate to the Company, or has sought to repudiate or disclaim, the Material Contract. |
8.1.4 |
Neither the Company nor, so far as the Warrantors are aware, any party with whom the Company has entered into a Material Contract is in material breach of the Material Contract. |
8.1.5 |
So far as the Warrantors are aware, no circumstances exist which would give rise to any breach of any Material Contract or to any such Material Contract being terminated or varied without the Companys consent (other than termination without cause upon notice in accordance with the terms of the agreement). |
9. |
EFFECT OF SALE |
Neither the execution nor the performance of this Agreement or any document to be executed at or before the Completion Date will result in the Company losing the benefit of any material asset, grant, subsidy, right or privilege which it enjoys at the date of this Agreement.
10. |
LIABILITIES |
10.1 |
Indebtedness |
The Company does not have outstanding and has not agreed to create or incur loan capital, borrowings, indebtedness in the nature of borrowings other than the trade debt incurred in the ordinary and usual course of trading.
10.2 |
Guarantees and indemnities |
The Company is not a party to and is not liable under a guarantee, indemnity or other agreement to secure or incur a financial or other obligation with respect to another persons obligation.
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142
10.3 |
Grants |
10.3.1 |
The Company is not liable to repay an investment or other grant or subsidy made to it by a body (including the Department for Business, Innovation and Skills or its predecessor). |
10.3.2 |
No fact or circumstance (including the execution and performance of this Agreement) exists which might entitle a body to require repayment of, or refuse an application by the Company for, the whole or part of a grant or subsidy. |
11. |
RESTRICTIONS ON BUSINESS ACTIVITIES |
Other than the Transaction Documents, there is no contract, judgment, injunction, order or decree binding upon the Company as of the date of this Agreement which has or would reasonably be expected to have, whether before or after Completion, the effect of prohibiting, restricting or impairing any current or presently proposed business practice of the Company, any acquisition of property by the Company or the conduct or operation of the Companys business or limiting the freedom of the Company to engage in any line of business, to sell, license or otherwise distribute services or products in any market or geographic area, or to compete with any person.
12. |
SERVICE PROVIDERS |
12.1 |
The Company has never employed or engaged any employees, consultants, advisory board members, or independent contractors. The Company has never maintained or offered any: |
12.1.1 |
employee benefit plans; |
12.1.2 |
loan to any independent contractor or consultant; |
12.1.3 |
stock option, stock purchase, phantom stock, stock appreciation right, supplemental retirement, severance, sabbatical, medical, dental, vision care, disability, employee relocation, cafeteria benefit, dependent care, life insurance or accident insurance plans, programs or arrangements; |
12.1.4 |
bonus, pension, profit sharing, savings, severance, retirement, deferred compensation or incentive plans, programs or arrangements; |
12.1.5 |
other fringe or employee benefit plans, programs or arrangements; or |
12.1.6 |
employment or executive compensation or severance agreements, written or otherwise. |
12.2 |
None of the execution and delivery of this Agreement, the Completion or any other transaction contemplated hereby or any termination of employment or service or any other event in connection therewith or subsequent thereto will, individually or together or with the occurrence of some other event: |
12.2.1 |
result in any payment (including severance, unemployment compensation, golden parachute, bonus or otherwise) becoming due to any person; |
12.2.2 |
increase or otherwise enhance any benefits otherwise payable by the Company; |
12.2.3 |
result in the acceleration of the time of payment or vesting of any such benefits; |
12.2.4 |
obligate the payment of compensation to any person; or |
12.2.5 |
result in the forgiveness in whole or in part of any outstanding loans made by the Company to any person. |
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13. |
INTERESTED PARTY TRANSACTIONS |
None of the officers and directors of the Company and, as far as the Warrantors are aware, none of the employees of the Company or Shareholders, nor, so far as the Warrantors are aware, any immediate family member of an officer, director, employee or Shareholder, has any direct or indirect ownership, participation, or other interest in, or is an officer, director, employee of or consultant or contractor for any firm, partnership, entity or corporation that competes with, or does business with, or has any contractual arrangement with, the Company (except with respect to (i) F-star or F-star GmbH or (ii) any interest in less than five per cent (5%) of the issued share capital of any Company whose shares are publicly traded). None of said officers, directors or Shareholders or, so far as the Warrantors are aware, any employees or member of their immediate families of the foregoing, is a party to or otherwise directly interested in, any contract to which the Company is a party or by which the Company or any of its assets or properties may be bound or affected in a material manner. As far as the Warrantors are aware, none of said officers, directors, employees or Shareholders has any material interest in any property, real or personal, tangible or intangible (including any Intellectual Property) that is directly related to the business of the Company.
14. |
COMPLIANCE WITH OPTION AGREEMENT |
At all times since the Effective Date (as defined in the Option Agreement) the Company has complied in all material respects with its covenants set forth in the Option Agreement.
15. |
INSOLVENCY, WINDING UP ETC. |
15.1 |
Winding up |
No order has been made, petition presented or resolution passed for the winding up of the Company or for the appointment of a liquidator or provisional liquidator to the Company.
15.2 |
Administration |
No administrator has been appointed in relation to the Company. So far as the Warrantors are aware, no notice has been given or filed with the court of an intention to appoint an administrator. No petition or application has been presented or order made for the appointment of an administrator in respect of the Company.
15.3 |
Receivership |
No receiver or administrative receiver has been appointed, nor any notice given of the appointment of any such person, over the whole or part of the Companys business or assets.
15.4 |
Moratorium |
No moratorium has been sought or has been granted under section 1A of the Insolvency Act 1986 in respect of the Company.
15.5 |
Voluntary arrangements |
No voluntary arrangement has been proposed under section 1 of the Insolvency Act 1986 in respect of the Company.
15.6 |
Scheme of arrangement |
No compromise or arrangement has been proposed, agreed to or sanctioned under Part 26 (Arrangements and Reconstructions) of the Act in respect of the Company, nor has any application been made to, or filed with, the court for permission to convene a meeting to vote on a proposal for any such compromise or arrangement.
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15.7 |
Informal arrangements with creditors |
The Company has not proposed or agreed to a composition, compromise, assignment or arrangement with any of its creditors.
15.8 |
Inability to pay debts |
The Company is not unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986. There are no unsatisfied written demands that have been served on the Company pursuant to section 123(1)(a) of the Insolvency Act 1986. There is no unsatisfied judgment or court order outstanding against the Company.
15.9 |
Payment of debts |
The Company has not stopped payment of, nor is it unable to pay, its debts as they fall due, nor has the Company commenced negotiations with one or more of its creditors with a view to rescheduling or restructuring any of its indebtedness.
15.10 |
Distress |
No distress, execution, attachment, sequestration or other process has been levied on an asset of the Company which remains undischarged.
15.11 |
Striking out |
No action is being taken by the Registrar of Companies to strike the Company off the register under section 1000 of the Act.
15.12 |
Analogous proceedings |
The Company is not, in any jurisdiction, subject to or threatened by any other procedures or steps which are analogous to those set out above.
16. |
COMPETITION |
So far as the Warrantors are aware, the Company has not failed to comply with or infringed the competition laws or regulations of any jurisdiction or been investigated for alleged non-compliance or infringement or given any undertaking in connection therewith.
17. |
LITIGATION AND COMPLIANCE WITH LAW |
Nothing in this Warranty concerns any matters concerned with any Intellectual Property.
For the purposes of this paragraph 12:
Agent means, with respect to an entity, any director, officer, employee or other representative of such entity; any person for whose acts such entity may be vicariously liable; and any other person that acts for or on behalf of, or provides services for or on behalf of, such entity, in each case, whilst acting in his capacity as such;
17.1 |
Litigation |
17.1.1 |
Neither the Company nor, so far as the Warrantors are aware, a person for whose acts or defaults the Company may be vicariously liable is involved, or has been involved, in a civil, criminal, arbitration, administrative or other proceeding. The Company has not received written notice that any civil, criminal, arbitration, administrative or other proceeding is pending or threatened by or against the Company or the assets or properties of the Company, or any of the directors, officers or employees of the Company (in their capacities as such or relating to their employment, services or relationship with the Company) or, so far as the Warrantors are aware, a person for whose acts or defaults the Company may be vicariously liable. So far as the |
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Warrantors are aware, there is no reasonable basis for any action, suit, proceeding, claim, mediation, arbitration or investigation against the Company or the assets or properties of the Company, or any of the directors, officers or employees of the Company (in their capacities as such or relating to their employment, services or relationship with the Company) or a person for whose acts or defaults the Company may be vicariously liable. |
17.1.2 |
There is no outstanding judgment, order, decree, arbitral award or decision of a court, tribunal, arbitrator or governmental agency against the Company, any of its assets or properties, or a person for whose acts or defaults the Company may be vicariously liable. |
17.1.3 |
So far as the Warrantors are aware, there is no reasonable basis for any Person to asset a claim against the Company based upon the Company entering into this Agreement or any of the Transaction Documents. |
17.2 |
Compliance with law |
17.2.1 |
The Company has conducted its business and dealt with its assets in all material respects in accordance with applicable legal and administrative requirements. |
17.2.2 |
The Company has obtained each governmental consent, license, permit, grant, or other authorization of a governmental entity that is required for the operation of the Companys business or the holding of its assets or properties (all of the foregoing consents, licenses, permits, grants, and other authorizations, collectively, the Company Authorizations) and all of the Company Authorizations are in full force and effect. The Company has not received any notice or other communication from any governmental entity regarding (i) any actual or possible violation of law or of any Company Authorization or any failure to comply with any term or requirement of any Company Authorization or (ii) any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any Company Authorization. None of the Company Authorizations will be terminated or impaired, or will become terminable, in whole or in part, as a result of the consummation of the transactions contemplated by this Agreement. |
17.3 |
Investigations |
There is not and has not been any governmental or other investigation, enquiry or disciplinary proceeding concerning the Company that the Company has been notified of and, so far as the Warrantors are aware, none is pending or threatened.
17.4 |
Making unlawful payments |
Neither the Company nor, so far as the Warrantors are aware, any of its Agents has paid, offered, promised, given or authorised the payment of money or anything of value directly or indirectly to any person:
17.4.1 |
intending to induce a person to improperly perform a function or activity or to reward a person for any such performance; or |
17.4.2 |
while knowing or believing that the acceptance by that person would constitute the improper performance of a function or activity. |
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17.5 Receiving unlawful payments
Neither the Company nor so far as the Warrantors are aware, have any of its Agents has directly or indirectly requested, agreed to receive or accepted money or anything of value:
17.5.1 |
as a reward for the improper performance of a function or activity by any person; |
17.5.2 |
in circumstances which amount to an improper performance of a function or activity; or |
17.5.3 |
intending that as a consequence of any such request, agreement to receive or acceptance a function or activity will be performed improperly. |
SCHEDULE 8
Limitations on Sellers Liability
1. |
LIMITATION ON QUANTUM |
1.1. |
No Warrantor shall be liable in respect of [***] unless and until the amount that would otherwise be recoverable from the Warrantors (in aggregate) in respect of [***], when aggregated with any other amounts recoverable in respect of [***] exceeds [***] (the Threshold), in which case the Warrantors shall be liable [***]. |
1.2. |
The total aggregate liability of the Warrantors in respect of [***] shall be limited in accordance with clause 6.3. |
1.3. |
The liability in respect of each Seller in respect of [***] shall be limited to a maximum amount equal to [***] of the aggregate of the Total Consideration paid to such Seller, except for [***] with respect to [***] set forth in [***], which shall be limited to a maximum amount of [***]. The liability in respect of each Seller in respect of [***] shall be limited to a maximum amount equal to [***], except in the case of [***], which shall be limited to a maximum amount of [***]. |
1.4. |
The liability of each Seller, in respect of [***] made against such Seller, and the liability of each Warrantor for [***], and [***] against a Seller shall be limited to a maximum amount equal to [***]. |
2. |
TIME LIMITATIONS |
2.1. |
No Seller, in respect of [***], or Warrantor, in respect of [***], shall be liable for such Claim (as the case may be) unless the Buyer has given the Sellers Representative and each Warrantor notice of such Claim (as the case may be), which notice shall state in reasonable detail the nature of the Claim, the grounds on which it is based (including which Warranty has or Warranties have been breached) and a good faith estimate of the amount claimed and must be notified to the Sellers Representative or Warrantor (as the case may be): |
(a) |
on or before the date that is [***] after the Completion Date in respect of [***]; |
(b) |
on or before [***] in respect of [***]; or |
(c) |
on or before [***] in respect of [***]. |
2.2. No Seller shall be liable for [***] or Warrantor shall be liable for [***] unless proceedings in respect of such Claim (as the case may be) are issued and served on the Sellers Representative within a period of [***] starting on the day of the Buyers notification of such Claim pursuant to Section 2.1 above and provided that such Claim has not otherwise been satisfied, settled or withdrawn.
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3. |
RECOURSE FOR [***] |
In the event that any Seller is liable to the Buyer in respect of [***]following the earlier of (i) exhaustion of the money standing to the credit of the Escrow Account and (ii) the Release Date, the Buyers [***] recourse for such liability shall be [***].
4. |
NO LIMITATION FOR FRAUD ETC. |
Nothing in this Schedule 8 shall have the effect of limiting or restricting any liability of any Seller or Warrantor in respect of a Claim arising as a result of any fraud, wilful misconduct or wilful concealment by or on behalf of that Seller or Warrantor.
5. |
RECOVERY ONLY ONCE |
The Buyer is not entitled to recover more than once in respect of any one matter giving rise to a loss or liability under this Agreement.
6. |
THIRD PARTY RECOVERY |
6.1. |
If the Sellers pay to a Buyers Group Undertaking an amount in respect of a Claim and a Buyers Group Undertaking subsequently recovers from another person an amount which is referable to the matter giving rise to the Claim: |
(a) |
if the amount paid by the Sellers in respect of the Claim is more than the Sum Recovered, the Buyer shall promptly pay to the Sellers the Sum Recovered; and |
(b) |
if the amount paid by the Sellers in respect of the Claim is less than or equal to the Sum Recovered, the Buyer shall promptly pay to the Sellers an amount equal to the amount paid by the Sellers. |
For the purposes of paragraph 6.1 of this Schedule 8, Sum Recovered means an amount equal to the total of the amount recovered from the other person plus any interest in respect of the amount recovered from that person less all reasonable costs incurred by a Buyers Group Undertaking in recovering the amount from the person.
6.2. |
If the Buyer or a Buyers Group Undertaking becomes aware that matters have arisen which will or could reasonably be expected to give rise to a Claim, the Buyer will (or will procure that the relevant Buyers Group Undertaking will) where practicable (and provided such information is not subject to confidentiality or is not privileged) disclose in writing to the Sellers Representative such information and documents relating to the Claim as the Sellers Representative may reasonably request (at the sole cost of the Sellers) and will consult with those Sellers to the extent practicable and have regard to their reasonable representations in respect of the resolution of the Claim. |
7. |
ACCOUNTS |
The Sellers shall have no liability in respect of any Claim if and to the extent that any allowance, provision or reserve was made or otherwise reflected in the Accounts or the Completion Accounts in respect of the matter or circumstances giving rise to the Claim.
8. |
TAX |
8.1. |
The Sellers shall not be liable in respect of [***] to the extent that: |
(a) |
it has been discharged or made good without cost or loss to the Buyer; or |
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(b) |
it arises or is increased as a result of any increase in the rates of Tax announced after the date of this Agreement; or |
(c) |
it arises or is increased by virtue of the failure or omission by the Company or the Buyer to make any claim, election, surrender or disclaimer or give any notice or consent or do any other thing after Completion (otherwise than at the written request of the Sellers), the making, giving or doing of which was taken into account or assumed in computing any provision or reserve for Tax in the Completion Accounts; or |
(d) |
any Relief (other than a Relief which has been reflected or shown as an asset in the Completion Accounts, or has been taken into account in calculating any provisions for Tax in the Completion Accounts) is available to reduce or eliminate such Tax liability. |
9. |
CHANGE IN LAW |
The Sellers shall not be liable in respect of any Claim to the extent that it arises, or its value is increased, as a result of a change in any law, legislation, rule or regulation (including any new law, legislation, rule or regulation) that comes into force or otherwise takes effect after the date of this Agreement.
10. |
VOLUNTARY ACTS |
10.1. |
The Sellers shall not be liable in respect of any Claim to the extent that the matter or circumstance giving rise to such Claim arises, occurs or is otherwise attributable to, or the Sellers liability pursuant to such Claim is increased as a result of: |
[***]
10.2. |
The Sellers shall not be liable in respect of any Claim to the extent that [***]. |
11. |
SET OFF |
11.1. |
Subject to the procedures set forth in paragraph 11.2 below, the Buyer shall be entitled to deduct from the Contingent Consideration payable to a Seller or Sellers when it becomes due and payable in accordance with the provisions of Schedule 5 (Contingent Consideration), an amount equal to any Claim which may exist at the date upon which the Contingent Consideration falls due to be paid by the Buyer; provided, however, that in respect of [***], the Buyer may only deduct or withhold from the Contingent Consideration payable to the Sellers the proportion of the Contingent Consideration (as notified by the Sellers Representative pursuant to clause 3.5 of the Agreement) that is due or becomes due to [***]. |
11.2. |
If in connection with a payment of Contingent Consideration that has become due and payable in accordance with the provisions of Schedule 5 (Contingent Consideration), the Buyer in good faith believes that a Claim exists and the Buyer intends to make a deduction to such Contingent Consideration as permitted under paragraph 11.1 above, the Buyer shall, within three (3) Business Days following such payment becoming due and payable, deliver to the Sellers Representative and each Warrantor a notice in writing (a |
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Set Off Notice) of such Claim, which Set Off Notice shall state in reasonable detail the nature of the Claim, the grounds on which it is based (including which Warranty has or Warranties have been breached) and a good faith estimate of the amount claimed (the Set Off Claim). If the Sellers Representative wishes to dispute the Set Off Claim on behalf of the Sellers or any Seller, it may, within twenty (20) Business Days of receipt of the Set Off Notice, indicate the same by written notice to the Buyer (the Set Off Dispute Notice) which also shall state in reasonable the basis for the Sellers Representatives dispute and the grounds on which it is based, in which case, either the Buyer or the Sellers Representative may then elect to initiate an alternative dispute resolution proceeding pursuant to the procedures set forth in clause 23.3 for purposes of having the Set Off Claim settled (a Set Off ADR) |
11.3. |
Promptly following timely receipt of the Set Off Dispute Notice, the Buyer shall deposit the applicable Contingent Consideration into escrow with SunTrust Bank or another escrow agent mutually acceptable to the Buyer and the Sellers Representative. The applicable Contingent Consideration shall be released from escrow and paid in accordance with the decision of the arbitrators in such Set Off ADR. |
11.4. |
For the avoidance of doubt, the set-off right set out in this paragraph 11 shall not apply to [***]. |
12. |
[***] |
[***].
13. |
CONDUCT OF THIRD PARTY CLAIMS |
13.1. |
The provisions of this paragraph 13 shall apply in the event that any third party brings or makes (or threatens to bring or make) any claim, demand, action or proceedings against any of the Buyer or a Buyers Group Undertaking which may reasonably be considered likely to give rise to a Claim (a Third Party Claim). |
13.2. |
In the event of a Third Party Claim, the Buyer shall: |
(a) |
as soon as reasonably practicable [***] give written notice of the Third Party Claim to the Sellers Representative, specifying in reasonable detail the nature of the Third Party Claim; |
(b) |
permit the Sellers Representative to participate in the defence of (but not conduct or control) such Third Party Claim at the expense of the Sellers Representative; |
(c) |
keep the Sellers reasonably informed (through the Sellers Representative) of the progress of, and all material developments in relation to, the Third Party Claim; |
(d) |
provide the Sellers Representative with copies of all material information and correspondence relating to the Third Party Claim; and |
(e) |
give (and cause each relevant Buyers Group Undertaking to give) the Sellers Representative and/or its professional advisers access at reasonable times (and on reasonable prior notice) to its premises and personnel, and to any relevant assets, accounts, documents or records within its control, for the purposes of enabling the Sellers to assess the Third Party Claim and to exercise their rights under this paragraph 13.2. |
13.3. |
The Buyer shall have the right in its sole discretion to conduct the defence of and to settle or resolve such Third-Party Claim. However, without the prior written consent of the Sellers Representative, which consent will not be unreasonably withheld, delayed or conditioned, [***]. In the event that the Sellers Representative has consented in writing [***], neither the Sellers Representative nor any Seller shall have any power or authority to object [***]. |
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13.4. |
The Sellers shall indemnify the Buyer in respect of all costs, charges and expenses that are reasonably and properly incurred by the Buyer (or any other member of the Buyers Group) in connection with the defence of a Third Party Claim. |
14. |
PROVISION OF INFORMATION |
If, at any time after the date of this Agreement, a Seller wants to insure against its liabilities in respect of a Claim, the Buyer shall provide such information and assistance as a prospective insurer may reasonably require before effecting the insurance.
15. |
PRESERVATION OF INFORMATION |
The Buyer shall, and shall ensure that each Buyer Group Company will, use reasonable endeavours to preserve all documents, records, correspondence, accounts and other information whatsoever relevant to a matter which may give rise to a Claim.
16. |
RELEASING SELLER FROM LIABILITY |
The Buyer may release or compromise in whole or in part the liability of any of the Sellers under this Agreement or grant any time or indulgence to that Seller without affecting the liability of any other Seller.
17. |
CONTINGENT LIABILITIES |
If any potential Claim arises as a result of a contingent or unquantifiable liability of any Buyers Group Undertaking, each Seller will not be obliged to pay any sum in respect of the potential Claim until the liability either ceases to be contingent or becomes quantifiable; provided, however, that this paragraph 17 shall not restrict the Buyer from setting off and deducting the Buyers reasonable estimate of any such potential Claim from Contingent Consideration, as permitted by paragraph 11.
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EXECUTED and DELIVERED as |
) | |
a DEED by SHAREHOLDER | ) | |
REPRESENTATIVE SERVICES |
) |
|
LLC. acting by an authorised officer | ||
In the presence of: | ||
Signature of Witness: |
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Name of Witness: |
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|
Address of Witness: |
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Occupation of Witness: |
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EXECUTED and DELIVERED as a DEED |
||
by | ||
an authorised signatory of | ||
In the presence of: |
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Signature of Witness: |
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Name of Witness: |
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Address of Witness: |
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Occupation of Witness: |
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SCHEDULE 3
Form of Exercise Notice
NOTICE OF EXERCISE OF OPTION AGREEMENT
To: |
Shareholder Representative Services LLC Attn: Managing Director 1614 15th Street Suite 200 Denver CO 80202 United States |
The Board of Directors F-star Gamma Limited Eddeva B920 Babraham Research Campus Cambridge CB22 3AT |
This notice comprises an Exercise Notice for the purposes of clause 5 of the option agreement between, among others, Denali Therapeutics Inc., F-star Gamma Limited (the Company) and the shareholders in the Company dated [insert date] (the Option Agreement).
Capitalised terms in this Exercise Notice have the same meanings given to them in the Option Agreement unless otherwise indicated.
We hereby exercise the option to acquire all of the issued share capital of the Company in accordance with the provisions of the SPA.
This Exercise Notice shall constitute [***] for the purposes of the SPA.
|
||
Name: |
for and on behalf of |
||
DENALI THERAPEUTICS INC. |
Date:
EXECUTED and DELIVERED as a |
) | |||
DEED by F-STAR GAMMA | ) | |||
LIMITED acting by a director: | ) |
/s/ John Haurum |
||
In the presence of: | ||||
Signature of Witness: | [***] | |||
Name of Witness: | [***] | |||
Address of Witness: | [***] | |||
[***] | ||||
Occupation of Witness: | [***] |
EXECUTED and DELIVERED as a |
) | |||
DEED by DENALI | ) | |||
THERAPEUTICS INC. acting by an |
) | |||
authorised officer: |
/s/ Ryan Watts, CEO |
|||
In the presence of: | ||||
Signature of Witness: | [***] | |||
Name of Witness: | [***] | |||
Address of Witness: | [***] | |||
[***] | ||||
Occupation of Witness: | [***] |
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EXECUTED and DELIVERED as a |
) | |||
DEED by SHAREHOLDER | ) | |||
REPRESENTATIVE SERVICES |
) | |||
LLC., solely in its capacity as the | ) | |||
Shareholders Representative, as acting |
) | |||
by an authorized officer |
) |
/s/Illegible |
||
In the presence of: | ||||
Signature of Witness: | [***] | |||
Name of Witness: | [***] | |||
Address of Witness: | [***] | |||
[***] | ||||
Occupation of Witness: | [***] |
EXECUTED and DELIVERED as a DEED by |
) | |||||
) | ||||||
|
, | ) | ||||
an authorised signatory of | ) | |||||
|
) | |||||
) | ||||||
) | ||||||
) |
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|||||
In the presence of: |
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|||||
Signature of Witness: |
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|||||
Name of Witness: |
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|||||
Address of Witness: |
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Occupation of Witness: |
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Schedule 1.51
TfR Fcab Desired Drug Candidate Profile (DCP) and Fcab Delivery Criteria
[***]
Schedule 1.51
TfR Fcab Discovery Plan
[***]
Confidential
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154
Schedule 1.89
Licensor Background Patents
[***]
Schedule 11.4
Press Release
F-star Announces Collaborative Agreement with Denali Therapeutics for the
Development of a Multispecific Antibody Platform to Deliver Therapeutics
Across the Blood-Brain Barrier
Cambridge, UK and South San Francisco, USA 25 August 2016 F-star, a biopharmaceutical company developing novel bispecific antibodies, announces a collaborative agreement with Denali Therapeutics Inc. (Denali), a biotechnology company focused on neurodegenerative disorders, to research and develop antibodies for the delivery of medicines across the blood-brain barrier (BBB) into the central nervous system (CNS).
The collaboration will leverage F-stars Modular Antibody TechnologyTM and Denalis expertise in the development of therapeutics for neurological diseases to generate FcabsTM (constant Fc-domains with antigen-binding activity) which can bind to transporters in the BBB. Using the plug-and-play properties of the platform, these Fcabs can be rapidly inserted into any existing antibody to generate a full size bispecific antibody (mAb² TM) which can both cross the BBB, as well as bind to specific targets within the CNS. This mechanism has the potential to treat neurological diseases by acting on specific targets in the brain.
The agreement is with F-star Gamma Limited (F-star Gamma), a new Asset-Centric Vehicle in the F-star family. Under the agreement, Denali will make upfront payments to F-star totalling $6 million. Denali has the option to nominate a pre-specified number of Fcab targets. F-star Gamma will also receive research funding and is eligible for technical milestone payments. In addition, Denali also has the option to acquire F-star Gamma prior to the initiation of the first Phase 1 clinical trial in return for aggregate exercise and milestone payments to the F-star Gamma shareholders of up to $450M in total. If Denali does not exercise the option to acquire F-star Gamma, it has the right to license a pre-specified number of mAb² based on each Fcab generated by F-star Gamma, in return for license fees, development, regulatory and commercial milestones payments with a potential aggregate value of $1B and tiered royalties on product sales.
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F-star Schedule of Cases for Denali - July 2016
John Haurum, CEO of F-star, commented: Our Modular Antibody Technology is ideally suited to deliver biologic drugs into the Central Nervous System across the blood-brain barrier. Denalis scientists are world leaders in understanding the complex mechanisms of the blood-brain barrier and we look forward to collaborating with the team to unlock the potential of our platform and develop more efficient treatments for neurological disorders.
Ryan Watts, CEO of Denali, said: We are excited to partner with F-star to tackle one of the toughest problems in medicine, delivery of biologics across the blood-brain barrier. F-stars deep expertise and proven track record of engineering novel antibodies offer a promising approach for the treatment of neurological disease.
-Ends-
For further information, please contact:
F-star
John Haurum
Chief Executive Officer
+ 44 7881 244 040
john.haurum@f-star.com
Jane Dancer
Chief Business Officer
+ 44 7739 174 297
jane.dancer@f-star.com
Hume Brophy for F-star
Mary Clark, Eva Haas, Alexia Faure
+44 207 862 6381
fstar@humebrophy.com
About F-star
F-star is a clinical-stage biopharmaceutical company developing bispecific antibody immuno-oncology products selected for their potential to transform the treatment of cancer. Through the application of its highly efficient Modular Antibody Technology platform, F-star is the only biotechnology company able to create bispecific antibodies where the second binding site is in the constant Fc region of an antibody.
The strength of the technology and programmes has been leveraged through partnerships with leading biopharmaceutical companies including AbbVie, Bristol-Myers Squibb, Merck Serono and Boehringer Ingelheim. F-star has currently one program in the clinic with a second immuno-oncology program heading toward IND. The Company has built a comprehensive IP estate around its technology and product pipeline, with over 50 patent applications filed and over 25 granted patents.
F-stars management team has a well-established track record in building successful biotech companies, and developing biologics. The team is advised by a world-leading scientific advisory board and a highly experienced board of directors. F-star has raised close to $100M in non-dilutive capital and revenues. The company currently employs over 60 people at its research site in Cambridge, UK.
For more information visit www.f-star.com
Confidential
F-star Schedule of Cases for Denali - July 2016
About Denali Therapeutics Inc.
Denali Therapeutics Inc. is a privately held biotechnology company focused on the discovery and development of therapies for patients with neurodegenerative disease, including Alzheimers disease, Parkinsons disease, ALS and others. Located in South San Francisco, Denali was founded by Drs. Marc Tessier-Lavigne, Ryan Watts, Alex Schuth and investors who share the vision that recent scientific insights in genetics, biology and translational medicine offer an unprecedented opportunity to discover and develop effective medicines for neurodegenerative disease. Denali is rigorously pursuing a science-driven approach to translational medicine and clinical development. Founding investors include ARCH Venture Partners, F-Prime Biosciences, Flagship Ventures and the Alaska Permanent Fund. To learn more, visit our website: www.denalitherapeutics.com.
Confidential
Exhibit 10.30
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
21 May 2018
From: |
F-star Gamma Limited (Gamma) |
|
Eddeva B920 |
||
Babraham Research Campus |
||
Cambridge CB22 3AT |
||
F-star Biotechnology Limited (Ltd) |
||
Eddeva B920 |
||
Babraham Research Campus |
||
Cambridge CB22 3AT |
||
F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.h (GmbH) |
||
C/O F-start Biotechnology Limited |
||
Eddeva B920 |
||
Babraham Research Campus |
||
Cambridge CB22 3AT |
||
To: |
Denali Therapeutics Inc. (Denali) |
|
201 Gateway Boulevard |
||
South San Francisco |
||
CA, United States |
||
Attention: Ryan Watts, CEO |
||
Re: | Exercise of Buy-out Option pursuant to the Collaboration Agreements | |
Dear Ryan,
As you know, since 2016 Denali and F-star have developed a collaborative and productive business relationship. As Denali prepares to execute the Buy-out Option Agreement (as defined in the LCA) pursuant to Section 7.1 of the LCA the Parties have discussed the progress of the Denali Fcabs and have agreed various clarifications and some amendments to the LCA and the Gamma IP Licence.
These clarifications and amendments reflect the precise Fcab development path and timings which has arisen since the original agreements were signed.
CONFIDENTIAL | 1 |
[F-star Letterhead]
Capitalized terms used in this letter agreement (the Letter) but not defined herein have the meanings set forth in the LCA.
F-star Parties | means Gamma, GmbH and Ltd | |
Gamma IP License | means the Amended and Restated Gamma IP License Agreement between Ltd and Gamma dated 24 August 2016. | |
LCA | means the License and Collaboration Agreement between Denali, Gamma, GmbH and Ltd dated 24 August 2016 | |
Second Accepted Fcab Target | means the Target listed as the Second Fcab Target in the table set out in paragraph 1.2.1 of this letter or any Target which replaces such Target following a substitution pursuant to paragraph 1.2.3 of this letter. | |
Third Accepted Fcab Target | means the Target listed as the Third Fcab Target in the table set out in paragraph 1.2.1 of this letter or any Target which replaces such Target following a substitution pursuant to paragraph 1.2.3 of this letter. |
Based on our recent discussions, Denali and the F-star Parties have agreed as follows. This Letter shall be effective upon signature by all of the parties with a signature line provided below, effective as of the date of the last such signature (the Letter Effective Date).
1.1 |
Exclusivity Fees. The Parties have agreed that no Denali Fcab Delivery Notice has been received by Gamma as of the Letter Effective Date and as such, the requirement that Denali make payments to Gamma pursuant to Section 9.4 or Section 9.5 of the License Agreement has not arisen as of the Letter Effective Date and that, provided Denali acquires the shares of Gamma pursuant to the Buy-Out Option Agreement by 1 September 2018, shall not arise during the process of the Buy-Out Option exercise. |
1.2 |
Target Nomination and Fcab Selection. |
1.2.1 |
Target Selection. Upon the Letter Effective Date, the following target shall be the second Accepted Fcab Target: |
Second Accepted Fcab Target | ||
Target | [***] | |
Entrez Gene ID | [***] | |
HUGO ID | [***] | |
Common Synonyms | [***] |
CONFIDENTIAL | 2 |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request
[F-star Letterhead]
At any time after the Letter Effective Date (but not later than [***] and subject to Section 1.2.5 of this Letter), Denali shall have the right to nominate the third Accepted Fcab Target using the same gatekeeping process as set out in Article 3 of the Gamma IP Licence. For clarity, Denali is paying the selection payment for the third Accepted Fcab Target in advance pursuant to Section 1.2.2 of this Letter, so no additional selection payment shall be due upon Denalis nomination (or subsequent clearance) of the third Accepted Fcab Target. For clarity, after the nomination (and clearance) of the third Accepted Fcab Target, the substitution right under Section 1.2.3 shall apply to the third Accepted Fcab Target in accordance with the terms of Section 1.2.3.
1.2.2 |
Target Selection payment payable to Ltd. Denali and the F-star Parties hereby agree that (i) [***] Denali shall pay to Ltd the sum of six million dollars ($6,000,000) within [***] hereof; and (ii) the provisions of Section 9.3 of the LCA shall no longer apply. |
1.2.3 |
Substitution of Accepted Fcab Target. In addition to Denalis and Gammas rights to [***] pursuant to [***] and [***] Gamma shall have the right to substitute (i) the Second Accepted Fcab Target [***] and (ii) the Third Accepted Fcab Target [***] on the following terms: |
(a) |
Such substitution may not take place after Denali has given a written request to Ltd to [***] without the prior written consent of Ltd. |
(b) |
Such substitution shall be made using the same process as set out in Article 3 of the Gamma IP Licence except that the Fcab Target Nomination Notice shall name the Accepted Fcab Target being deselected by Gamma and the proposed Accepted Fcab Target being selected by Gamma. Such Fcab Target shall be subject to the same gatekeeping process as set out in Article 3 of the Gamma IP Licence. |
(c) |
On the receipt of the Gatekeeper Notice indicating that the proposed Accepted Fcab Target is not on the Unavailable Target List such proposed Accepted Fcab Target shall become an Accepted Fcab Target in place of the Second or Third (as the case may be) Accepted Fcab Target and the Accepted Fcab Target that was deselected shall cease to be an Accepted Fcab Target. |
(d) |
The Fcab Target Nomination Notice for the substitution of the Second or Third (as the case may be) Accepted Fcab Target according to this paragraph 1.2.3 of this Letter shall be received by Ltd: (i) in respect of the Second Accepted Fcab Target (as set out in the table above), before [***]; and (ii) in respect of the Third Accepted Fcab Target (as set out in the table above), before [***]. Any Fcab Target Nomination Notice received after the relevant date shall be invalid. |
(e) |
For the avoidance of doubt, Denali shall not be entitled to substitute the TfR Accepted Fcab Target. |
CONFIDENTIAL | 3 |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request
[F-star Letterhead]
1.2.4 |
The Parties shall commence work on the preparation of an Fcab Discovery Plan in respect of the Second Accepted Fcab Target [***] following the [***] and the Parties shall commence work under such Fcab Discovery Plan on the written request of Denali. In the event that Denali has not requested Ltd to commence work under such Fcab Discovery Plan by [***] in respect of the Second Accepted Fcab Target, such Target would cease to be an Accepted Fcab Target and all of Denalis rights and obligations under the LCA or the Gamma IP Licence in respect of the Second Accepted Fcab Target shall cease from such date and none of the F-star Parties shall have any obligation to Denali in respect of it. |
1.2.5 |
The Parties shall commence work on the preparation of an Fcab Discovery Plan in respect of the Third Accepted Fcab Target on the written request of Denali. In the event that Denali has not requested Ltd to commence work under an Fcab Discovery Plan by [***] in respect of the Third Accepted Fcab Target, such Target would cease to be an Accepted Fcab Target and all of Denalis rights and obligations under the LCA or the Gamma IP Licence in respect of the Third Accepted Fcab Target shall cease from such date and none of the F-star Parties shall have any obligation to Denali in respect of it. |
1.3 |
Continuation of the Milestone Payments in respect of the LCA. The Parties to this letter agree that: |
1.3.1 |
The obligation to make payments under Section 9.6 and 9.11 of the LCA shall be deleted from the LCA, and for clarity nothing is therefore owed under Sections 7.5.1 or 7.5.2 of the Gamma IP License with respect to the payments under Section 1.3.2 below. |
1.3.2 |
Denali shall pay to Ltd, on an Accepted Fcab Target basis, the following one-time (per Accepted Fcab Target), [***],[***] milestone payments within [***] days after: |
(a) |
Fcab Delivery: (a) [***] if the Fcab Delivery was in the circumstances described in Section 4.3.1 of the LCA or (b) [***] if the Fcab Delivery was deemed achieved in the circumstances described in Section 4.3.2 of the LCA; |
(b) |
the first initiation of GMP manufacture of a Licensed Product with respect to such Accepted Fcab Target: (i) [***], and (ii) in the case Denali had only paid [***] under Section 1.3.2(a) above for the applicable Fcab Delivery, then an additional [***]; provided that this additional payment under clause (ii) shall only be due one (1) time with respect to a particular Fcab. |
CONFIDENTIAL | 4 |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request
[F-star Letterhead]
1.3.3 |
Denali Fcab Payment Reductions. In the event that for a given Accepted Fcab Target, (i) the Proposed Fcab provided by Ltd to Denali fails to meet the Fcab Delivery Criteria for that Accepted Fcab Target (or Ltd was otherwise unable to provide to Denali a Proposed Fcab during the [***] period after Denali has transferred to Ltd all reagents and assays for Ltd to conduct the antigen validation (e.g. conclusion of Step 1, Antigens of Schedule 1.5.1 of the LCA for the TfR Fcab Discovery Plan or [***]) under the applicable Fcab Discovery Plan); (ii) Denali has provided to Ltd the Denali Fcab Notice with respect to a Denali Fcab for such Accepted Fcab Target; provided that solely for purposes of this Section 1.3.3 of this Letter the parties agree that this Letter will serve as the Denali Fcab Notice for TfR; and (iii) Ltd does not provide to Denali an Fcab against that Accepted Fcab Target which meets the relevant Fcab Delivery Criteria within the later of (a) [***] after Denali has transferred to F-star all reagents and assays for F-star to conduct the antigen validation (e.g. conclusion of Step 1, Antigens of Schedule 1.5.1 of the LCA for the TfR Fcab Discovery Plan or [***]) under the applicable Fcab Discovery Plan, and (b) [***] after the date Denali provides to Licensor the Denali Fcab Notice (the Fcab Disclosure Period); then all of the payments set out in paragraph 1.3.2 above in respect of the relevant Fcab and any such payment in respect of a mAb2 incorporating such Fcab shall be reduced by [***] such that the amount payable is [***]. The Parties agree that the Fcab Disclosure Period for TfR Accepted Fcab Target shall expire upon [***]. If the Proposed Fcab for an Accepted Fcab Target failed to meet the Fcab Delivery Criteria, and Ltd subsequently provides to Denali during the Fcab Disclosure Period another Licensor Fcab for validation testing, then Denali shall only be obligated to conduct [***] additional validation experiment(s) for such additional Licensor Fcab, and if such additional Licensor Fcab does not meet the Fcab Delivery Criteria, then Licensor shall be responsible to reimburse Denali for its costs to conduct such additional validation experiment(s) in respect of [***] Licensor Fcab only. In addition, Ltd shall be entitled (but not obliged) to conduct, at its own cost, [***] validation experiment(s) for [***] Licensor Fcab in addition to the [***] Licensor Fcabs that are subject to the validation experiments carried out by Denali, provided such validation experiment(s) is carried out within the Fcab Disclosure Period. The above reduction shall not apply: |
(a) |
if Ltd delivers the sequence of an Fcab against such Accepted Fcab Target which within such period meets or subsequently is found to meet the Fcab Delivery Criteria prior to expiration of the Fcab Disclosure Period for such Accepted Fcab Target, and, upon the date of Fcab Delivery of such an Fcab, Denali shall pay to Ltd the difference between the amounts that were paid in respect of the Denali Fcab and the amounts that would have been paid if Denali had selected a Licensor Fcab. For clarity, if at the time the milestone payment due under Section 1.3.2(b) of this Letter becomes due with respect to an Accepted Fcab Target, Ltd has not yet delivered to Denali a Proposed |
CONFIDENTIAL | 5 |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request
[F-star Letterhead]
Fcab that meets the Fcab Delivery Criteria for that Accepted Fcab Target, and Denali did not select a Licensor Fcab or Joint Fcab for such Accepted Fcab Target for the development of mAb2 (as evidenced by initiation of GMP manufacture as described in clause (b) below), then the milestone payable under Section 1.3.2(b) by Denali shall be reduced by [***] such that the amount payable is [***], subject to Denali paying to Ltd the difference thereof if Ltd delivers a Fcab during the Fcab Disclosure Period that meets the Fcab Delivery Criteria as provided above in this clause (a); |
(b) |
if, notwithstanding that the Fcab against such Accepted Fcab Target delivered by Ltd did not meet the relevant Fcab Delivery Criteria, Denali nevertheless selects a Licensor Fcab or Joint Fcab for the development of mAb2 as evidenced by initiation of GMP manufacture for a Licensed Product that incorporates such Licensor Fcab or Joint Fcab; or |
(c) |
in respect of any mAb2 which contains a Licensor Fcab or a Joint Fcab. |
Notwithstanding the final paragraph of this letter or the provisions of Section 13.11 of the Gamma IP Licence, this paragraph 1.3 shall (in addition to the F-star Parties) be for the benefit of and enforceable by the Shareholders of Gamma.
1.4 |
Technical Development. |
1.4.1 |
Following the Letter Effective Date, the definition of the Technical Development Term in the LCA shall be deleted and replaced by the following: Technical Development Term means the Term |
1.4.2 |
Following the Letter Effective Date, the definition of the Technical Development Term in the Gamma IP Licence shall be deleted and replaced by the following: Technical Development Term means the Term |
1.4.3 |
In addition to Gammas obligations under Section 4.3 of the Gamma IP Licence, Gamma shall, and shall procure that Denali shall, within [***] following the end of each [***] during the Technical Development Term, provide to Ltd (i) [***] and (ii) a [***] during such [***] and the [***]. Gammas obligations under this Section 1.4.3, including its obligations under Section 4.3 of the Gamma IP License, shall expire upon [***] (as defined in the Gamma IP License). |
CONFIDENTIAL | 6 |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request
[F-star Letterhead]
1.5 |
Diligence. Without limiting Sections 4.2, 4.3, and 4.7 of the LCA, in respect of the second and third Accepted Fcab Targets, following Denalis written request to Ltd to [***], Denali shall [***] to [***] transfer to Gamma [***] and perform [***] and [***]. In addition, Denali shall [***] transfer to Gamma [***] in connection with and as necessary for [***]. |
1.6 |
Gamma IP License. The parties acknowledge that the first sentence of Section 13.3.2 of the Gamma IP License shall not apply to Denalis acquisition of Gamma, such that following the Completion (as defined in the Buy-Out Option Agreement), Denali shall be an Affiliate of Gamma for purposes of the Gamma IP License. |
1.7 |
Disclosure Notice. The Parties acknowledge that concurrently with the execution of this Letter Denali is providing a Disclosure Notice pursuant to the Buy-Out Option Agreement. |
Please confirm your agreement to the foregoing by countersigning this Letter below and returning a signed copy to me.
This Letter may be executed in any number of counterparts, each of which when executed shall constitute a duplicate original, but all the counterparts together shall constitute the one agreement.
The provisions of Section 7.10, 7.11 and 7.12 of the Gamma IP Licence shall apply to any payments to be made pursuant to this Letter on the basis that the reference to Party therein, for the purposes of this letter only, [***].
CONFIDENTIAL | 7 |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request
[F-star Letterhead]
This Letter, including any non-contractual disputes or claims, shall be governed by and construed in accordance with the laws of England and Wales and the provisions of Article 13 of the Gamma IP Licence shall apply to it.
Yours sincerely, |
/s/ John Haurum |
Name: John Haurum, CEO |
For and on behalf of F-STAR GAMMA LIMITED |
/s/ John Haurum |
Name: |
For and on behalf of F-STAR BIOTECHNOLOGY LIMITED |
/s/ John Haurum |
Name: |
For and on behalf of F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H |
Acknowledged and agreed by: |
/s/ Ryan Watts |
Name: Ryan Watts, CEO |
For and on behalf of DENALI THERAPEUTICS INC. |
8
Exhibit 10.31
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
Confidential |
GAMMA SUPPORT SERVICES AGREEMENT
among
F-STAR BIOTECHNOLOGY LIMITED,
and
F-STAR GAMMA LIMITED
Dated as of 24 August 2016
CONFIDENTIAL
TABLE OF CONTENTS
Page | ||||||
GAMMA SUPPORT SERVICES AGREEMENT |
I | |||||
ARTICLE 1 |
DEFINITIONS |
2 | ||||
ARTICLE 2 |
MANAGEMENT OF THE RELATIONSHIP |
11 | ||||
ARTICLE 3 |
SERVICES |
12 | ||||
ARTICLE 4 |
FCAB DELIVERY |
14 | ||||
ARTICLE 5 |
PAYMENTS AND RECORDS |
15 | ||||
ARTICLE 6 |
INTELLECTUAL PROPERTY |
16 | ||||
ARTICLE 7 |
CONFIDENTIALITY AND NON-DISCLOSURE |
18 | ||||
ARTICLE 8 |
REPRESENTATIONS AND WARRANTIES |
23 | ||||
ARTICLE 9 |
INDEMNITY |
27 | ||||
ARTICLE 10 |
TERM AND TERMINATION |
33 | ||||
ARTICLE 11 |
MISCELLANEOUS |
35 |
i
CONFIDENTIAL
THIS AMENDED AND RESTATED LICENSE AGREEMENT is made and entered into effective as of 24 August 2016 (the Effective Date) by and between
(1) |
F-STAR BIOTECHNOLOGY LIMITED, a limited liability company incorporated under the laws of England and Wales (F-star), |
(2) |
F-STAR GAMMA LIMITED, a limited liability company incorporated under the laws of England and Wales (Gamma) |
F-star and Gamma are sometimes referred to herein individually as a Party and collectively as the Parties.
BACKGROUND
(A) |
F-star Controls (as defined herein) certain intellectual property rights with respect to Fcabs (as defined herein), mAb2 (as defined herein). |
(B) |
Gamma has been incorporated to develop Fcabs with respect to blood-brain barrier transcytosis. |
(C) |
On the Effective Date F-star and Gamma entered into the Gamma IP License Agreement (as herein defined). |
(D) |
Under separate agreements dated the same date as this Agreement, Gamma has granted to Denali Therapeutics Inc. (Denali) a research and development license and an option to take a licence under a License and Collaboration Agreement (the Denali License Agreement) and the shareholders of Gamma have granted an option to purchase the entire share capital of Gamma under a Buy-out Option Agreement (as defined herein) pursuant to the terms of the Share Puchase Agreement attached thereto. |
(E) |
F-star has agreed to provide the services to Gamma to enable Gamma to comply with its obligations under the Denali License Agreement, and following completion by Denali of the acquisition of Gamma following the exercise of the Buy-out Option, to enable Gamma to continue to receive the services that were contemplated in the Denali License Agreement. |
1
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement and the Schedules to this Agreement the following capitalized terms, whether used in the singular or plural, shall have the meanings set out below:
1.1 |
Accepted Fcab Target means an Fcab Target that has become an Accepted Fcab Target as provided for in the Gamma IP License Agreement. |
1.2 |
Affiliate means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, control and, with correlative meanings, the terms controlling, controlled by and under common control with means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity. Notwithstanding the foregoing: (i) none of [***] shall be deemed an Affiliate of F-star or of each other, other than [***], which are Affiliates solely of each other; and (ii) no company with substantially the same shareholders as [***] shall be an Affiliate of [***]. |
2
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.3 |
Agreement means this agreement and all schedules, appendices and other addenda attached hereto as any of the foregoing may be amended in accordance with the provisions of this Agreement. |
1.4 |
Antibody shall have the meaning in the Denali License Agreement. |
1.5 |
Applicable Law means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder. |
1.6 |
Approved Subcontractors means those subcontractors of F-star as agreed to by the Parties in writing. |
1.7 |
Breaching Party has the meaning set forth in Section 10.2. |
1.8 |
Business Day means a day other than a Saturday or Sunday on which banking institutions in San Francisco, California or London, England are open for business. |
1.9 |
Buy-out Option Agreement shall have the meaning in the Denali License Agreement. |
1.10 |
Buy-out Option shall have the meaning in the Denali License Agreement. |
1.11 |
Buy-out Option Period shall have the meaning in the Denali License Agreement. |
1.12 |
Calendar Quarter means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. |
1.13 |
Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. |
3
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.14 |
Commercially Reasonable Efforts means, with respect to the performance of the Services with respect to a Fcab, a mAb2 or a Licensed Product by a Party, the carrying out of such activities using efforts and resources [***]. |
1.15 |
Confidential Information means any Information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement after the Effective Date, including Information relating to the terms of this Agreement, any Fcab, any mAb2 or any Licensed Product, any Exploitation of any Fcab or any mAb2 or any Licensed Product, any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates (including Gamma Know-How and F-star Know-How, as applicable), or the scientific, regulatory or business affairs or other activities of either Party. Notwithstanding the foregoing, (a) Patents and Know-How of F-star will be considered Confidential Information of F-star and (b) Patents and Know of Gamma (including the Gamma Program Patents and the Gamma Program Know-How) will be considered Confidential Information of Gamma. |
1.16 |
Control means, with respect to any item of Information, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise, to grant a license, sublicense or other right to or under such Information, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party; provided, that neither Party shall be deemed to Control any item of Information, material, Patent, or other property right of a Third Party if access under this Agreement requires or triggers a payment obligation, unless the Party being granted a sublicense hereunder to such Information, material, Patent or other property right agrees in writing to pay such payment obligation. |
4
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.17 |
Default Notice has the meaning set forth in Section 10.2. |
1.18 |
Denali has the meaning in the Denali License Agreement |
1.19 |
Denali License Agreement has the meaning set out in paragraph (C) of the Background above. |
1.20 |
Development means all activities related to pre-clinical and other non-clinical discovery, research, testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, including manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, Develop means to engage in Development. For purposes of clarity, Development shall include any submissions and activities required in support thereof, required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved molecule or product. |
1.21 |
Dispute has the meaning set forth in Section 11.6. |
1.22 |
Dollars or $ means United States Dollars. |
1.23 |
Drug Approval Application means a Biologics License Application (a BLA) as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (a MAA) filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure. |
5
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.24 |
Effective Date means the effective date of this Agreement as set forth in the preamble hereto. |
1.25 |
Exploit or Exploitation shall have the meaning in the Denali License Agreement. |
1.26 |
Fab means the region on an Antibody that (a) binds to an antigen and is either composed of (i) one (1) constant and one (1) variable domain of each of the heavy and the light chain wherein the binding sites are located in the variable domains, or (ii) another protein or biologic that specifically binds to an antigen or substrate, or (b) constitutes [***], or, subject to agreement (or resolution) as set out in Section 3.3 of the Denali License Agreement, [***] (an Incorporated Biologic). |
1.27 |
Fcab means a constant domain of an Antibody that includes an antigen binding site that confers a specific binding of such constant domain to a defined Target antigen. |
1.28 |
Fcab Discovery Plan shall mean an Fcab Discovery Plan as set out in the Denali License Agreement. |
1.29 |
F-star Alpha means F-star Alpha Limited, a limited liability company incorporated under the laws of England and Wales with registered number 08676690. |
1.30 |
F-star Beta means F-star Beta Limited, a limited liability company incorporated under the laws of England and Wales with registered number 092635320. |
1.31 |
F-star GmbH means F-star Biotechnologische Forschungs - Und Entwicklungsges.M.B.H, an Austrian limited liability company incorporated under the laws of the Republic of Austria. |
1.32 |
F-star Indemnitees has the meaning set forth in Section 9.1. |
1.33 |
F-star Know-How shall have the meaning set out in the Gamma IP License Agreement. |
1.34 |
F-star Patents shall have the meaning set out in the Gamma IP License Agreement. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.35 |
FTE Rate means, for the period from the Effective Date to 31 December 2017, [***]. Thereafter, the FTE Rate shall be increased or decreased on 1 January of each year by the annual percentage increase or decrease in the UK Consumer Price Inflation published by the UK Office of National Statistics. |
1.36 |
FTE means the equivalent of the work of one appropriately qualified individual working on a full-time basis in performing work in connection with this Agreement for a twelve (12) month period (consisting of at least a total of [***] hours per year of dedicated effort). FTE efforts shall not include the work of general corporate or administrative personnel. |
1.37 |
Gamma Fcab means an Fcab which is directed to an Accepted Fcab Target. |
1.38 |
Gamma Indemnitees has the meaning set forth in Section 9.2. |
1.39 |
Gamma IP License Agreement means that Amended and Restated License Agreement, between F-star and Gamma, dated as of the Effective Date, as may be amended or restated from time to time. |
1.40 |
Gamma Program Know-How means any and all Know-How that is developed or invented after the Effective Date solely by F-star or jointly with Gamma or Denali in performing Services, and that is not Platform Know-How (as defined in the Denali License Agreement) and to the extent (a) constituting the composition of matter, use, formulation or manufacturing of an Fcab, mAb2 or Fab, or (b) arising from the performance of activities under a mAb2 Development Plan. |
1.41 |
Gamma Program Patents means any and all Patents that claim inventions that are invented after the Effective Date solely by F-star or jointly with Gamma or Denali in performing Services, and that are not Platform Patents (as defined in the Denali License Agreement), and to the extent (a) constituting the composition of matter, use, formulation or manufacturing of an Fcab, mAb2 or Fab, or (b) arising from the performance of activities under a mAb2 Development Plan. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.42 |
Incorporated Biologic has the meaning set forth in Section 1.26. |
1.43 |
Indemnification Claim Notice has the meaning set forth in Section 9.3. |
1.44 |
Indemnified Party has the meaning set forth in Section 9.3. |
1.45 |
Indirect Taxes has the meaning set forth in Section 5.6. |
1.46 |
Information means all information of a technical, scientific, business and other nature, including Know-How, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed. |
1.47 |
Know-How means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions. |
1.48 |
Licensed Product shall have the meaning in the Denali License Agreement. |
1.49 |
Losses has the meaning set forth in Section 9.1. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.50 |
mAb2 means an Antibody (a) which contains a Gamma Fcab and (b) which contains a Fab or an Incorporated Biologic. |
1.51 |
Non-Breaching Party has the meaning set forth in Section 10.2. |
1.52 |
Patent Challenge has the meaning set forth in Section 10.3 |
1.53 |
Patents means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, and (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b), and (c)) |
1.54 |
Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. |
1.55 |
Regulatory Approval means, with respect to a country or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to commercialize a mAb2 or Licensed Product in such country or other jurisdiction, including, where applicable, (a) pricing or reimbursement approval in such country or other jurisdiction, and (b) pre- and post-approval marketing authorizations (including any prerequisite manufacturing approval or authorization related thereto). |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.56 |
Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or Regulatory Authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of any mAb2 or Licensed Products in the Territory. |
1.57 |
Senior Officer means, with respect to Gamma, its Chief Executive Officer or his/her designee, and with respect to F-star, its Chief Executive Officer or his/her designee. |
1.58 |
Services means the services to be carried out by F-star in fulfilment of Gammas obligations under the Denali License Agreement as further described in Section 3.1, and if Denali terminates the Denali License Agreement after completion by Denali of the acquisition of Gamma following the exercise of the Buy-out Option, the services to be carried out by F-star to enable Gamma to continue to receive the services that were contemplated in the Denali License Agreement. For the avoidance of doubt, the Services shall not include services provided by F-star to Gamma to support any agreement between Gamma and any Third Party other than pursuant to, or as contemplated by, the Denali License Agreement. |
1.59 |
Target means the target antigen specifically bound by the Fcab in an Antibody. |
1.60 |
Term means the period commencing on the Effective Date and expiring on the expiry of the term of this Agreement as set forth in Section 10.1 or the earlier termination in accordance with the terms of this Agreement. |
1.61 |
Territory means all countries and territories worldwide. |
1.62 |
Third Party Claims has the meaning set forth in Section 9.1. |
1.63 |
Third Party means any Person other than F-star Gamma and their respective Affiliates. For clarity each of F-star Alpha, and F-star Beta shall be deemed Third Parties. |
1.64 |
TfR means Transferrin Receptor also known as TFR1, TRFR and TFR which is identified by UniProt number P02786. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.65 |
In this Agreement: |
1.65.1 |
all references to a particular clause, section or schedule shall be a reference to that clause, section or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement; |
1.65.2 |
the headings are inserted for convenience only and shall be ignored in construing this Agreement; |
1.65.3 |
words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa; |
1.65.4 |
words denoting persons shall include any individual, partnership, company, corporation, joint venture, trust association, organisation or other entity, in each case whether or not having separate legal personality; |
1.65.5 |
the words include, included and including are to be construed without conveying any limitation to the generality of the preceding words; |
1.65.6 |
reference to any statute or regulation includes any modification or re-enactment of that statute or regulation; |
1.65.7 |
any reference to notices or consent being sought or given in writing shall require the consent or notice to be signed by an appropriately authorised person and shall not include consents or notices conveyed by email; and |
1.65.8 |
in the event of any inconsistency or conflict between this Agreement and any of the Schedules, this Agreement shall prevail. |
ARTICLE 2
MANAGEMENT OF THE RELATIONSHIP
2.1 |
Prior to the exercise by Denali of the Buy-out Option F-star shall represent Gamma in the JSC under the Denali License Agreement. After the exercise by Denali under the Buy-out Option Gamma and F-star shall establish a Joint Steering Committee with representatives from both Denali and F-star which shall operate on the same basis as set out in Section 2 of the Denali License Agreement. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
ARTICLE 3
SERVICES
3.1 |
F-star shall carry out the Services on behalf of Gamma as follows: |
3.1.1 |
F-star shall, subject to Section 3.1.5 and subject to ARTICLE 5, undertake the obligations of Gamma as provided for in the Denali License Agreement in relation to the TfR Fcab Discovery Plan (and shall continue to undertake such obligations after termination of the Denali License Agreement following completion by Denali of the acquisition of Gamma following the exercise of the Buy-out Option). |
3.1.2 |
Gamma shall transfer to F-star [***]. F-star shall not be obliged to commence any work on the discovery of Fcabs unless and until it has received [***] from Gamma as provided for in the [***]. |
3.1.3 |
On receipt of such [***] referred to in Section 3.1.2, F-star shall, subject to Section 3.1.5 and subject to ARTICLE 5, undertake the obligations of Gamma as provided for in the Denali License Agreement (or after termination of the Denali License Agreement following completion by Denali of the acquisition of Gamma following the exercise of the Buy-out Option, the obligations that were contemplated in the Denali License Agreement) in relation to the [***] for the second and third Accepted Fcab Targets provided always that if such [***] are to be agreed after Denali has exercised its Buy-out Option, then such [***] shall be subject to [***] provided [***]. |
3.1.4 |
F-star shall, subject to agreement of the activities in the relevant mAb2 Development Plan, provide technical support provided always that F-star shall not be obligated to expend any resources or incur any costs in excess of [***], without F-stars prior written consent, which consent shall be in its sole discretion; |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
3.1.5 |
F-star shall use Commercially Reasonable Efforts to carry out each Fcab Discovery Plan and its responsibilities under any mAb2 Development Plan. F-star shall provide Gamma with [***] written reports detailing the progress of its activities under each [***] and [***]. |
3.1.6 |
Following Fcab Delivery (as defined in the Denali License Agreement) of the first Fcab for each Accepted Fcab Target F-star shall (to the extent it Controls any such Information) make available to Gamma any Information and materials specifically identified in the relevant Fcab Discovery Plan not already provided. |
3.1.7 |
F-star shall maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law and regulatory guidance, which shall be complete and accurate and shall properly reflect all work done and results achieved in the performance of its obligations under each Fcab Discovery Plan and mAb2 Development Plan, which, after the Effective Date, shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such records shall be retained by F-star for at least [***] after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Upon request, F-star shall provide copies of the records it has maintained pursuant to this Section 3.1.7 to Gamma. |
3.1.8 |
F-star shall provide such other Services as are agreed between the Parties. |
3.1.9 |
For clarity, after termination of the Denali License Agreement following completion by Denali of the acquisition of Gamma following the exercise of the Buy-out Option, the Parties and Denali intend that the Services that F-star was providing to Gamma to support Gammas obligations under the Denali |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
License Agreement shall continue under this Agreement, and any provisions of the Denali License Agreement that must be incorporated by reference to achieve such purpose shall be deemed incorporated by reference into this Agreement including Denalis obligation to fund each Fcab Discovery Plan pursuant to Section 9.2 of the Denali License Agreement for the period set out therein notwithstanding that the Denali License Agreement may have terminated. |
3.2 |
F-star shall not subcontract its obligations under a Fcab Discovery Plan or a mAb2 Development Plan, except to Affiliates or otherwise as agreed with Gamma in each case where such subcontractor has agreed in writing to be subject to the applicable terms and conditions of this Agreement, including the requirements under Section 3.1.5, the confidentiality provisions of ARTICLE 7, and provided that F-star directly owns all Gamma Program Know-How and Gamma Program Patents that it is required to assign to Gamma pursuant to ARTICLE 6. |
ARTICLE 4
FCAB DELIVERY
4.1 |
Fcab Delivery After Buy-out Option Exercise. In the event that, at the date of completion by Denali of the acquisition of Gamma, Fcab Delivery (as defined in the Denali License Agreement) has not occurred under the Denali License Agreement for any Accepted Fcab Target then: |
4.1.1 |
the provisions of Sections 4.3, 4.4, and 4.5 of the Denali License Agreement shall be incorporated into this Agreement subject to references to the Licensor being interpreted as references to F-star and references to Denali being references to Gamma; and |
4.1.2 |
if the Proposed Fcab (as defined in the Denali License Agreement) has failed to meet the Fcab Delivery Criteria, F-star shall have the rights of Gamma pursuant to Section 9.11 of the Denali License Agreement to (i) provide to Denali an Fcab against that Accepted Fcab Target which for |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
validation testing within the Fcab Disclosure Period (as defined in the Denali License Agreement) and Denali shall continue to have the obligation to conduct [***] additional validation experiment(s) in respect of such Fcab (subject to F-star being responsible to reimburse Denalis costs if such Fcab does not meet the Fcab Validation Criteria); and (ii) to conduct validation experiments at F-stars costs on [***] Fcab in addition to the [***] Fcabs that were the subject of validation experiment(s) by Denali. |
ARTICLE 5
PAYMENTS AND RECORDS
5.1 |
Service Fees. [***] shall be responsible for FTE costs incurred by [***] in relation to each Fcab Discovery Plan and mAb2 Development Plan as set forth in the applicable Fcab Discovery Plan or mAb2 Development Plan, and subject to the following. For the TfR Fcab Discovery Plan [***] will fund [***]. Payment of such sums shall be paid in advance in accordance with the budget/FTE allocation agreed as a part of each Fcab Discovery Plan and mAb2 Development Plan. Promptly following the end of each Calendar Quarter, [***] shall provide to [***] a report with the actual costs incurred during such Calendar Quarter, and the Parties shall review those actual costs against the budget/FTE allocation. Following such review, and upon mutual written agreement between the Parties, the budget/FTE allocation may be increased or decreased. On an Accepted Fcab Target-by-Accepted Fcab Target basis, [***] obligation to fund such FTE costs incurred in relation to a Fcab Discovery Plan shall terminate on the earlier of (a) [***], and (b) [***]. |
5.2 |
Payments for other Services shall paid for in accordance with the budget agreed to for such Services at the time such Services are agreed. |
5.3 |
All invoices shall be billed and payable in Pounds Sterling. Invoices shall be payable within [***] of issue; provided that payments made by Gamma following completion by Denali of the acquisition of Gamma shall be paid in U.S. dollars. |
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5.4 |
Without limiting any other remedy of F-star, if Gamma fails to make any payment by the due date, F-star may charge interest in the amount overdue at the rate of [***] such interest accruing [***]. |
5.5 |
Mode of Payment. All payments to either Party under this Agreement shall be made from the UK to the UK, without setoff, by deposit of Dollars in the requisite amount to such bank account as F-star may from time to time designate by notice to Gamma. |
5.6 |
Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the Indirect Taxes). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within forty-five (45) days of receipt. |
ARTICLE 6
INTELLECTUAL PROPERTY
6.1 |
Grants by Gamma. Gamma hereby grants to F-star, from the Effective Date until [***], a non-exclusive license, with the right to grant sublicenses to Affiliates and Approved Subcontractors, under any Know-How or Patents Controlled by Gamma solely to conduct the Services. |
6.2 |
No Implied Rights. Except as expressly provided herein, F-star grants no other right or license under this Agreement, including any rights or licenses to any Patent, Know-How |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
or intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel, or otherwise. Except as expressly provided herein, Gamma grants no other right or license under this Agreement, including any rights or licenses to any Patent, Know-How or intellectual property property rights not otherwise expressly granted herein, whether by implication, estoppel or otherwise. |
6.3 |
Ownership of Intellectual Property. |
6.3.1 |
Save as provided in this Section 6.3, nothing in this Agreement shall operate to assign any Patents or Know-How from one Party to the other. |
6.3.2 |
Ownership of Technology. |
(a) |
Disclosure Obligation. F-star shall promptly disclose to Gamma in writing, the conception, discovery, development or making of any Gamma Program Patent or Gamma Program Know-How. |
(b) |
Assignment Obligation. F-star, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), to Gamma all its right, title and interest in and to any Gamma Program Know-How and Gamma Program Patents. F-star will execute and record assignments and other necessary documents consistent with such ownership and shall cause all Persons who perform the Services to be under an obligation to assign its rights in any Information and inventions resulting therefrom to Gamma. |
6.4 |
Prosecution, Maintenance, Enforcement of Gamma Patents. |
6.4.1 |
Gamma Patent Prosecution and Maintenance. Gamma shall have the sole right, but not the obligation, to prepare, file, prosecute, and maintain the Gamma Program Patents worldwide, at Gammas sole cost and expense. Gamma shall keep F-star reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance strategy (including timing of filing, data to be included, and scope of claims of Patent applications) of the Gamma Program Patents. |
17
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
6.4.2 |
Gamma shall have the sole right, but not the obligation, to defend and control the defense of the validity and enforceability of the Gamma Program Patents. |
6.5 |
Inventors Remuneration. F-star shall be solely responsible for any remuneration that may be due any inventors under any applicable inventor remuneration laws in respect of any Gamma Program Patents. |
ARTICLE 7
CONFIDENTIALITY AND NON-DISCLOSURE
7.1 |
Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party shall, and each of the foregoing shall cause its Affiliates and its and their respective officers, directors, employees, consultants, contractors and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement, including exercising rights granted hereunder. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 7.1 with respect to any Confidential Information shall not include any information that: |
7.1.1 |
has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party and its Affiliates, to the extent F-star is the receiving Party; |
18
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
7.1.2 |
have been in the receiving Partys possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
7.1.3 |
is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
7.1.4 |
that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
7.1.5 |
have been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Partys Confidential Information. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination are in the public domain or in the possession of the receiving Party.
7.2 |
Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
7.2.1 |
in the reasonable opinion of the receiving Partys legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators, but subject to Section 7.3); provided, that the receiving Party shall first have given prompt written notice |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(and to the extent possible, at least five (5) Business Days notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information (for example, quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed; |
7.2.2 |
made by or on behalf of the receiving Party or their licensees or sub-licensees to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with Applicable Law; |
7.2.3 |
subject to written consent of the disclosing Party, made by or on behalf of the receiving Party to a Patent authority as may be reasonably necessary or useful for purposes of obtaining, defending or enforcing a Patent; provided, that reasonable measures shall be taken to assure confidential treatment of such Confidential Information, to the extent such protection is available; |
7.2.4 |
made to its or its Affiliates, financial and legal advisors who have a need to know such disclosing Partys Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, at least as restrictive as those set forth in this Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and legal advisors, to treat such Confidential Information as required under this ARTICLE 7; |
20
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7.2.5 |
made by the receiving Party or its Affiliates to potential or actual investors, acquirers, investment bankers, lenders, as may be necessary in connection with their evaluation of a potential or actual investment in or acquisition of the receiving Party or its Affiliates; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 7. |
7.2.6 |
made by Gamma or its Affiliates or sublicensees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in connection with the Exploitation of any mAb2, the Licensed Products, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 7 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five (5) years from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors); or |
7.2.7 |
made by F-star, F-star GmbH, or F-star Ltd or their Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, and the like as may be necessary in assisting with F-stars activities contemplated by this Agreement (including in relation to the exercise of the rights granted to F-star in Sections 6.1 or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement); |
21
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of Gamma substantially similar to the obligations of confidentiality and non-use of F-star pursuant to this ARTICLE 7 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five (5) years from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors and the like). |
7.3 |
Public Announcements. Neither F-star, on the one hand, or Gamma and its Affiliates on the other, shall issue any public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the others prior written consent regarding the timing and content, except for any such disclosure that is, in the opinion of the disclosing entitys counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing entity are listed (or to which an application for listing has been submitted). Prior to the expiration of the Buy-out Option Period, any such public announcement, press release, or other public disclosure regarding this Agreement shall also require Denalis prior written consent, and after expiration of the Buy-out Option Period if Denali has not exercised the Buy-out Option, then any such public announcement, press release, or other public disclosure regarding this Agreement shall require Denalis prior written consent if the subject matter is regarding the Denali License Agreement. In the event an entity is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such entity shall submit the proposed disclosure in writing to Gamma or F-star as far in advance as reasonably practicable (and in no event less than seven (7) Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. Notwithstanding the foregoing, Gamma, its sublicensees and its and their respective Affiliates shall have the right to publicly disclose research, development and commercial information (including with respect to regulatory matters) regarding mAb2 and Licensed Products; provided, that such disclosure is subject to the provisions of ARTICLE 7 with respect to F-stars Confidential Information and Section 7.4. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
7.4 |
Return of Confidential Information. Upon the effective date of the termination of this Agreement with respect to any Accepted Fcab Target or mAb2 for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first Party does not retain rights under the surviving provisions of this Agreement: (a) as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) as soon as reasonably practicable, deliver to the requesting Party, at the other Partys expense, all copies of such Confidential Information in the possession of the other Party; provided, that the other Party shall be permitted to retain one (1) copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder, as required by Applicable Law, or for archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Partys automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Partys standard archiving and back-up procedures, but not for any other use or purpose. |
ARTICLE 8
REPRESENTATIONS AND WARRANTIES
8.1 |
Representations and Warranties of Gamma. Except as set forth in the Disclosure Schedule, Gamma represents and warrants, as of the Effective Date as follows: |
8.1.1 |
Organization. Gamma is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
8.1.2 |
Authorization. The execution and delivery of this Agreement and the performance by Gamma of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) Gammas |
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CONFIDENTIAL
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charter documents, bylaws, or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which such Gamma is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to Gamma. |
8.1.3 |
Binding Agreement. This Agreement is a legal, valid, and binding obligation of Gamma enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). |
8.1.4 |
No Inconsistent Obligation. Gamma is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder. |
8.1.5 |
There are no written claims, judgments, or settlements against, or amounts with respect thereto, owed by Gamma relating to (i) the Gamma Patents, or (ii) the Gamma Know-How. To Gammas knowledge, no written claim or litigation has been brought or threatened by any Person alleging that (a) the Gamma Patents are invalid or unenforceable, or (b) the Gamma Patents, or the Gamma Know-How, or the disclosing, copying, making, assigning, or licensing of the Gamma Patents, or the Gamma Know-How as contemplated by this Agreement violates, infringes, misappropriates or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party. |
8.1.6 |
To Gammas knowledge, the use of any Denali Background IP (as defined in the Denali License Agreement) disclosed to F-star for the conduct of the TfR Fcab Discovery Plan will not infringe, misappropriate, misuse, violate or otherwise make use without authorisation of any Third Party intellectual property nor has any person threatened to Gamma in writing to issue such a notice. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
8.2 |
Representations and Warranties of F-star. F-star represents and warrants to Gamma, as of the Effective Date as follows: |
8.2.1 |
Organization. F-star is a limited liability company duly incorporated and validly existing under the laws of England and Wales. F-star has all requisite power and authority, corporate or otherwise, to execute, deliver and perform its respective obligations under this Agreement. |
8.2.2 |
Authorization. The execution and delivery of this Agreement and the performance by F-star of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) F-stars articles of association or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which such F-star is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to F-star. |
8.2.3 |
Binding Agreement. This Agreement is the legal, valid and binding obligation of F-star enforceable in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the enforcement of creditors rights generally and by the effect of general principles of equity (regardless of whether enforcement is considered in a proceeding in equity or at law). |
8.2.4 |
No Inconsistent Obligation. F-star is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder. |
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8.2.5 |
No Claims. Except as disclosed by F-star to Gamma in writing in the letter from F-star to Gamma on the Effective Date, there are no written claims, judgments, or settlements against, or amounts with respect thereto, owed by F-star, or to F-stars knowledge by F-star GmbH, F-star Ltd or any of their respective Affiliates, relating to (i) the F-star Patents, or (ii) the F-star Know-How. To F-stars knowledge, no written claim or litigation has been brought or threatened by any Person alleging that (a) the F-star Patents are invalid or unenforceable, or (b) the F-star Patents, or the F-star Know-How, or the disclosing, copying, making, assigning, or licensing of the F-star Patents, or the F-star Know-How as contemplated by this Agreement violates, infringes, misappropriates or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party. |
8.2.6 |
No Misappropriation. Except as disclosed by F-star to Gamma in writing in the letter from F-star to Gamma on the Effective Date, to the Knowledge of F-star no Person is infringing or misappropriating (i) the F-star Patents, or (ii) the F-star Know-How. |
8.3 |
DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NONE OF F-STAR, F-STAR LTD, F-STAR GMBH OR GAMMA OR ANY OF THEIR RESPECTIVE AFFILIATES MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. |
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8.4 |
Gamma Liability After Exercise of Buy-out Option. On [***] of Denalis acquisition of Gamma following the exercise of the Buy-out Option, [***]. By way of examples, (a) [***], and (b) [***]. |
ARTICLE 9
INDEMNITY
9.1 |
Indemnification of F-star. Gamma shall indemnify F-star, its Affiliates and their respective directors, officers, employees, and agents (the F-star Indemnitees) and defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (including reasonable attorneys fees and expenses) (collectively, Losses) in connection with any and all suits, investigations, claims, or demands of Third Parties (collectively, Third Party Claims) incurred by or rendered against the F-star Indemnitees arising from or occurring as a result of: |
(a) |
the Exploitation of mAb2 or Licensed Products by or for Gamma or any of its Affiliates, sublicensees, subcontractors, agents and consultants, on a mAb2-by-mAb2 basis during the Term; |
(b) |
the breach by Gamma or its Affiliates of this Agreement; or |
(c) |
the gross negligence or willful misconduct on the part of Gamma or its Affiliates or their respective directors, officers, employees, and agents in performing its or their obligations under this Agreement; or |
(d) |
on an Accepted Fcab Target-by-Accepted Fcab Target basis, the infringement by F-star of any Third Party Patents or Know-How relating to the Accepted Fcab Target, solely to the extent (i) such infringement arose from F-stars conduct of services on behalf of Gamma (and not any subsequent research, development or commercialization of a Fcab to such Accepted Fcab Target by F-star or any product incorporating any such Fcab), and (ii) Gamma or Denali knew of such Third Party Patents or Know-How at the time the scope of the Services were agreed between F-star and Gamma. |
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except for those Losses for which F-star, in whole or in part, has an obligation to indemnify Gamma pursuant to Section 9.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses.
9.2 |
Indemnification of Gamma. F-star shall indemnify Gamma, its Affiliates and its and their respective directors, officers, employees, and agents (the Gamma Indemnitees), and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims incurred by or rendered against the Gamma Indemnitees arising from or occurring as a result of: |
(a) |
F-stars (or its Affiliates or sublicensees) use or practice of any Patents or Know-How of F-star; ; |
(b) |
the breach by F-star or its Affiliates of this Agreement; or |
(c) |
the gross negligence or willful misconduct on the part of F-star or its Affiliates or its or their respective directors, officers, employees, and agents in performing its obligations under this Agreement; |
except for those Losses for which Gamma has an obligation to indemnify F-star pursuant to Section 9.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
9.3 |
Notice of Claim. All indemnification claims in respect of a Party, F-star Ltd, F-star GmbH, and its and their respective Affiliates, or their respective directors, officers, employees and agents shall be made solely by such Party to this Agreement (the Indemnified Party). The Indemnified Party shall give the indemnifying Party prompt written notice (an Indemnification Claim Notice) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under this ARTICLE 9, but in no event shall the indemnifying Party be liable for any Losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims. |
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9.4 |
Control of Defense. |
9.4.1 |
In General. At its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within thirty (30) days after the indemnifying Partys receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the indemnifying Party shall not be construed as an acknowledgment that the indemnifying Party is liable to indemnify the Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the indemnifying party of any defenses it may assert against the Indemnified Partys claim for indemnification. Upon assuming the defense of a Third Party Claim, the indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the indemnifying Party which shall be reasonably acceptable to the Indemnified Party. In the event the indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall immediately deliver to the indemnifying Party all original notices and documents (including court papers) received by the Indemnified Party in connection with the Third Party Claim. Should the indemnifying Party assume the defense of a Third Party Claim, except as provided in Section 9.4.2, the indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party Claim unless specifically requested in writing by the indemnifying Party. In the event that it is ultimately determined that the indemnifying Party is not obligated to indemnify, defend or hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party for any Losses incurred by the indemnifying Party in its defense of the Third Party Claim. |
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9.4.2 |
Right to Participate in Defense. Without limiting Section 9.4.1, any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, that such employment shall be at the Indemnified Partys own expense unless (a) the employment thereof, and the assumption by the indemnifying party of such expense, has been specifically authorized by the indemnifying Party in writing, (b) the indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 9.4.1 (in which case the Indemnified Party shall control the defense), or (c) the interests of the Indemnified Party and the indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law, ethical rules or equitable principles. |
9.4.3 |
Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the Indemnified Partys becoming subject to injunctive or other relief or otherwise adversely affecting the business of the Indemnified Party in any manner, and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the indemnifying Party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 9.4.1, the indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss; provided, that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). If the indemnifying Party does not assume and conduct the defense of a Third Party Claim as provided |
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above, the Indemnified Party may defend against such Third Party Claim. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, no Indemnified Party shall admit any liability with respect to, or settle, compromise or dispose of, any Third Party Claim without the prior written consent of the indemnifying Party, which consent shall not to be unreasonably withheld, conditioned or delayed. The indemnifying Party shall not be liable for any settlement, compromise or other disposition of a Loss by an Indemnified Party that is reached without the written consent of the indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed. |
9.4.4 |
Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the indemnifying party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making Indemnified Parties and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the indemnifying Party shall reimburse the Indemnified Party for all its reasonable out-of-pocket expenses in connection therewith. |
9.4.5 |
Expenses. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis in arrears by the indemnifying Party, without prejudice to the indemnifying Partys right to contest the Indemnified Partys right to indemnification and subject to refund in the event the indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party. |
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9.4.6 |
Special, Indirect, and Other Losses. EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 9, NEITHER PARTY NOR ANY OF THEIR AFFILIATES SHALL BE LIABLE FOR ANY LOSS OF PROFITS OR BUSINESS INTERRUPTION OR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE IN CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THE USE OF THE LICENSED COMPOUND OR LICENSED PRODUCT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. |
9.4.7 |
Insurance. Each Party shall obtain and carry in full force and effect the minimum insurance requirements set forth herein. The types of insurance, and minimum limits shall be: General Liability Insurance with a minimum limit of One Million Dollars ($1,000,000) per occurrence and Two Million Dollars ($2,000,000) in the aggregate. General Liability Insurance shall include, at a minimum, beginning at least thirty (30) days prior to first commercial sale of a Licensed Product, product liability insurance. |
9.4.8 |
Certificates of Insurance. Upon request by a Party, the other Party shall provide certificates of insurance evidencing compliance with this Section. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain such insurance after the expiration or termination of this Agreement |
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for the longer of (a) a period of five (5) years following termination or expiration of this Agreement in its entirety, or (b) with respect to a particular Party, last sale of a Licensed Product (or but for expiration or termination, would be considered a Licensed Product) sold under this Agreement by a Party. |
ARTICLE 10
TERM AND TERMINATION
10.1 |
Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until the the provision of the Services has been completed hereunder. |
10.2 |
Termination for Material Breach. If either Party (the Non-Breaching Party) believes that the other Party (the Breaching Party) has materially breached one (1) or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a Default Notice). If the Breaching Party fails to cure such breach within [***] after receipt of the Default Notice the Non-Breaching Party may terminate this Agreement to the extent that it relates to the Accepted Fcab Target to which the breach relates, upon written notice to the Breaching Party. |
10.3 |
Termination by F-star for Patent Challenge. F-star will have the right to terminate this Agreement in full upon written notice to Gamma in the event that Gamma or any of its Affiliates or sublicensees directly assert in its own respective name or directs a Third Party to assert a Patent Challenge; provided that with respect to any such Patent Challenge by any non-Affiliate Sublicensee, F-star will not have the right to terminate this Agreement under this Section 10.3 if, within [***] of F-stars notice to Gamma under this Section 10.3, Gamma (a) causes such Patent Challenge to be terminated or dismissed or (b) terminates the sublicense granted to such non-Affiliate Sublicensee. For purposes hereof, Patent Challenge means any challenge in a legal or administrative proceeding to the patentability, validity, ownership or enforceability of any of the F-star Patents (or |
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any claim thereof), including by: (i) filing or pursuing a declaratory judgment action in which any of the F-star Patents is alleged to be invalid or unenforceable; (ii) citing prior art against any of the F-star Patents (other than art required to be cited by Applicable Law, including under a duty of candor to a Patent office), filing a request for or pursuing a re-examination of any of the F-star Patents (other than with F-stars written agreement), or becoming a party to or pursuing an interference; or (iii) filing or pursuing any opposition, cancellation, nullity or other like proceedings against any of the F-star Patents; but excluding any challenge raised as a defense or counterclaim against a claim, action or proceeding asserted by F-star or its Affiliates against Gamma or its Affiliates or sublicensees. |
10.4 |
Effects of Termination. I n the event of termination of this Agreement in its entirety or in relation to any Fcab Discovery Plan or mAb2 Development Plan or in respect of any other Services (a Plan) the following terms and conditions will apply, provided, however, that if the termination relates only to a particular Plan, then the following provisions will only apply with respect to such Plan: |
(a) |
Except as may otherwise be agreed in writing by the Parties Gamma shall be required to pay to F-star any costs incurred or to be incurred under any remaining activities under a Plan, including the remaining FTE costs unless F-star redeploys the relevant staff onto other projects (which, subject to the provisions of 3.1.9, F-star shall use its Commercially Reasonable Efforts to accomplish); |
(b) |
The obligations of F-star in relation to the affected Plans shall immediately terminate; |
(c) |
Except as set forth in ARTICLE 7, each Party shall return or cause to be returned to the other Party all Confidential Information and all substances or compositions of the other Party or its Affiliates delivered or provided by or on behalf of such other Party, as well as any other material provided by or on behalf of such other Party in any medium, in connection with such terminated Plan; |
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10.5 |
Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
10.6 |
Accrued Rights; Surviving Obligations. |
10.6.1 |
Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration, including any amounts due under ARTICLE 5. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, the following Sections shall survive such termination or expiration: Sections 3.1.7, 4.1.2, 6.2, 6.3, 6.4, 6.5, 8.4, 10.4, 10.5, 10.6, 11.3, 11.5, 11.6, 11.7 and 11.10 and ARTICLES 4, 7 and 9. |
ARTICLE 11
MISCELLANEOUS
11.1 |
Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts, or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing |
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Party shall notify the other Party of such force majeure within [***] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use Commercially Reasonable Efforts to remedy its inability to perform. |
11.2 |
Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law. |
11.3 |
Assignment. |
11.3.1 |
Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, no Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided, that a Party may make such an assignment without the other Partys consent to (a) [***], or (b) [***]. With respect to an assignment to [***] the assigning Party shall [***]. Any attempted assignment or delegation in violation of this Section 11.3 shall be void and of no effect. All validly assigned and delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of F-star or Gamma, as the case may be. The permitted assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement. Without limiting the foregoing, the grant of rights set forth in |
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this Agreement shall be binding upon any successor or permitted assignee of F-star, and the obligations of Gamma, including the payment obligations, shall run in favor of any such successor or permitted assignee of F-stars benefits under this Agreement. |
11.3.2 |
Notwithstanding anything to the contrary herein, in the event of the acquisition of a controlling (as such term is used in the definition of Affiliate) interest in F-star or F-star GmbH or Gamma the acquirer of such Person shall not be considered to be an Affiliate of such Person for the purposes of this Agreement including for the purposes of the definition Control in respect of the intellectual property of the Parties. For clarity, any Know-How, Patents or other intellectual property rights or other assets owned or Controlled by an acquirer or its Affiliates before such an acquisition of such Person or which were subsequently generated by the acquirer, or an Affiliate of the acquirer which is not F-star or an Affiliate of F-star immediately prior to the acquisition, will not be Controlled by such Person after such change in Control for purposes of this Agreement, except to the extent that F-star or F-star GmbH or any of their respective Affiliates owned or Controlled such Know-How, Patents or other intellectual property rights or other assets before such acquisition. |
11.4 |
Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect. |
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11.5 |
Governing Law, Jurisdiction and Service. |
11.5.1 |
Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction; provided, that all questions concerning the construction or effect of Patents shall be determined in accordance with the laws of the country or other jurisdiction in which the particular Patent has been filed or granted, as the case may be. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods. |
11.5.2 |
Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 11.7.2 shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
11.6 |
Dispute Resolution. If a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute), it shall be resolved pursuant to this Section 11.6. |
11.6.1 |
General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within [***] (or such other period of time as mutually agreed by the Senior Officers) after such issue was first referred to them, then, except as otherwise set forth in Section 11.6.2, either Party may, by written notice to the other Party, elect to initiate arbitration proceedings pursuant to the procedures set forth in Section 11.6.3 for purposes of having the matter settled. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
11.6.2 |
Intellectual Property Disputes. In the event that a Dispute arises with respect the validity, scope, enforceability, inventorship or ownership of any Patent, trademark or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 11.6.1, and, unless otherwise agreed by the Parties in writing, such Dispute shall not be submitted to arbitration in accordance with Section 11.6.3 and instead, either Party may initiate litigation in a court of competent jurisdiction, notwithstanding Section 11.5, in any country or other jurisdiction in which such rights apply. |
11.6.3 |
Arbitration. Should the informal resolution mechanism of Section 11.6.1 prove unsuccessful within the allotted period, then the Parties shall submit their dispute to binding arbitration [***]. Each Party shall appoint one arbitrator who at their turn shall nominate the chairperson, who shall be qualified in [***]. If a Party does not appoint its arbitrator within [***] following the expiry of the allotted period, then such arbitrator shall be selected in accordance with the then current rules of [***]. Any arbitrator so selected shall have substantial experience in the pharmaceutical industry. The arbitration shall be conducted, and all documents submitted to the arbitrators shall be, in English. The arbitrators shall have the power to include an award of attorneys fees and costs to the prevailing Party, but shall have no power to award punitive, special, incidental or consequential damages. The arbitrators decision and award shall be final and binding upon all Parties. Subject to any award that the arbitrators may make, each Party shall bear its own costs for its counsel and other expenses, and the Parties shall equally share the costs of the arbitration. Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction. |
11.6.4 |
Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 11.6 shall preclude either Party from seeking interim or |
39
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute following the ADR procedures set forth in Section 11.6.3, if necessary to protect the interests of such Party. This Section shall be specifically enforceable. |
11.7 |
Notices. |
11.7.1 |
Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand or (b) sent by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 11.7.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 11.7.1. Such notice shall be deemed to have been given as of the date delivered by hand or on the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 11.7.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. |
11.7.2 |
Address for Notice. |
If to F-star to:
F-star Biotechnology Ltd.
Eddeva B920 Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Chief Business Officer and cc: Head of IP
If to Gamma to:
F-star Gamma Ltd.
Eddeva B920 Babraham Research Campus
40
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Cambridge, CB22 3AT
UK
Attention: Chief Business Officer and cc: Head of IP
with a copy (which shall not constitute notice) to:
Cooley LLP
Dashwood
69 Old Broad Street London EC2M 1QS
Attention: John Wilkinson
11.8 |
Entire Agreement; Amendments. This Agreement, together with the Gamma IP License Agreement and the Denali License Agreement and Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby (including that certain Confidential Disclosure Agreement between Denali and F-star Ltd dated December 18, 2015; provided that (a) all Confidential Information disclosed or received thereunder will be deemed Confidential Information hereunder and will be subject to the terms and conditions of this Agreement, and (b) all rights and obligations under such agreement will otherwise continue in full force and effect as provided therein). Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. |
11.9 |
English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. |
11.10 |
Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on |
41
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein. |
11.11 |
No Benefit to Third Parties. Except as provided in ARTICLE 9, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. |
11.12 |
Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement. |
11.13 |
Relationship of the Parties. It is expressly agreed that F-star, on the one hand, and Gamma, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for tax purposes. Neither F-star, on the one hand, nor Gamma, on the other hand, shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party. |
42
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
11.14 |
Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by facsimile or electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures. |
[SIGNATURE PAGES FOLLOW.]
43
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
F-STAR BIOTECHNOLOGY LIMITED | ||
By: |
/s/ Jane Dancer |
|
Name: | Jane Dancer | |
Title: | CBO | |
F-STAR GAMMA LIMITED | ||
By: |
/s/ Tolga Hassan |
|
Name: | Tolga Hassan | |
Title: | CFO & Co. Sec. |
44
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Exhibit 10.32
EXECUTION VERSION
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
DATED | 30 May 2018 |
DENALI THERAPEUTICS INC. (1)
THE SELLERS (2)
and
SHAREHOLDER REPRESENTATIVE SERVICES LLC (as the Sellers Representative) (3)
SHARE PURCHASE AGREEMENT
relating to the entire issued share capital of
F-STAR GAMMA LIMITED
COOLEY (UK) LLP, DASHWOOD, 69 OLD BROAD STREET, LONDON EC2M 1QS, UK
T: +44 (0) 20 7583 4055 F: +44 (0) 20 7785 9355 WWW.COOLEY.COM
CONTENTS
1. |
INTERPRETATION |
2 | ||||
2. |
SALE AND PURCHASE |
11 | ||||
3. |
CONSIDERATION |
12 | ||||
4. |
POST COMPLETION ADJUSTMENTS |
15 | ||||
5. |
COMPLETION |
16 | ||||
6. |
ESCROW ACCOUNT |
18 | ||||
7. |
SELLER WARRANTIES AND INDEMNITY |
20 | ||||
8. |
LIMITATIONS TO THE SELLERS LIABILITY |
21 | ||||
9. |
BUYERS WARRANTIES |
22 | ||||
10. |
POST COMPLETION MATTERS |
23 | ||||
11. |
BUYER GUARANTEE |
25 | ||||
12. |
SELLERS REPRESENTATIVE |
27 | ||||
13. |
PAYMENTS |
32 | ||||
14. |
ANNOUNCEMENTS |
33 | ||||
15. |
CONFIDENTIALITY |
33 | ||||
16. |
COSTS |
35 | ||||
17. |
GENERAL |
36 | ||||
18. |
ENTIRE AGREEMENT |
37 | ||||
19. |
ASSIGNMENT |
37 | ||||
20. |
NOTICES |
38 | ||||
21. |
COUNTERPARTS |
39 | ||||
22. |
GOVERNING LAW |
39 | ||||
23. |
DISPUTE RESOLUTION |
39 | ||||
24. |
PROCESS AGENTS |
41 | ||||
25. |
CONFLICT WAIVER |
41 |
Agreed Form Documents
1. |
Disclosure Letter |
2. |
Escrow Agreement |
3. |
Loan Notes Instrument |
4. |
Press Release |
CONFIDENTIAL
THIS SHARE PURCHASE AGREEMENT is executed and delivered as a DEED on 30 May 2018
BETWEEN:
(1) THE PERSONS, whose names and addresses are set out in Schedule 1 (the Sellers);
(2) DENALI THERAPEUTICS INC., a corporation organised and existing under the laws of the State of Delaware, United States, having its principal place of business at 201 Gateway Boulevard, South San Francisco, California, United States (the Buyer); and
(3) SHAREHOLDER REPRESENTATIVE SERVICES LLC, a Colorado limited liability company and which is a party to this Agreement solely in its capacity as representative of the Sellers (the Sellers Representative).
WHEREAS:
(A) |
The Company is a private limited liability company incorporated under the laws of England and Wales and engaged in the delivery of therapeutics across the blood brain barrier. |
(B) |
As at the date of this Agreement, the Sellers own the Shares that constitute the entire issued share capital of the Company. The Sellers have agreed to sell to the Buyer, and the Buyer has agreed to purchase and accept, the Shares on the terms of this Agreement. |
IT IS AGREED as follows:
1. |
INTERPRETATION |
1.1. |
Definitions |
In this Agreement:
Accepted Fcab Target | is defined in Schedule 5 (Contingent Consideration); | |
Accounting Policies | means the accounting policies and procedures set out in Part C of Schedule 4 (Accounting Policies); |
CONFIDENTIAL
2
Accounts | means the Companys individual accounts (as that term is used in sections 394 and 395 of the Companies Act) and cash flow statement for the financial year ended on the Last Accounting Date, the auditors report on those accounts, the directors report for that year and the notes to those accounts; | |
Actual Net Cash | has the meaning given to it in Schedule 4. | |
ADR | has the meaning given to it in clause 23.2; | |
Affiliate | means, with respect to a party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, control and, with correlative meanings, the terms controlling, controlled by and under common control with means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). The parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity. Affiliates shall be construed accordingly; | |
Business Day | means a day (other than a Saturday or Sunday) on which banks generally are open for business in London, UK; | |
Business Warranty | means [***]; | |
Business Warranty Claim | means a claim by the Buyer for breach of a Business Warranty; | |
Buyers Account | means the bank account notified by the Buyer to the Sellers Representative from time to time; | |
Buyers Group | means the Buyer and the Buyers Group Undertakings; | |
Buyers Group Undertaking | means the Buyer or an undertaking which is a subsidiary undertaking or parent undertaking of the Buyer or a subsidiary undertaking of a parent undertaking of the Buyer and, for the avoidance of doubt, includes the Company from Completion, and Buyers Group Undertakings shall be construed accordingly; | |
Cash | means the aggregate of all cash held by the Company immediately following Completion, but excluding the Pass Through Amount; | |
Cash Sellers | means each of the Sellers other than the Loan Note Sellers; | |
Claim | means any Business Warranty Claim, Tax Warranty Claim, Special Indemnity Claim (including any Fraud Claim), Warrantor Fundamental Warranty Claim and/or Fundamental Warranty Claim, and Claims means any two or more of them; | |
Company | means F-star Gamma Limited, a private limited company incorporated under the laws of England and Wales under company number 10214672, having its registered office at Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT; | |
Company Confidential Information | means any Information or data relating to any Fcab or mAb2 Product, any Exploitation of any Fcab or mAb2 Product, any Know-How with respect thereto developed by or on behalf of Company or its Affiliates, or the scientific, regulatory or business affairs or other activities of the Company; | |
Completion | means completion of the sale and transfer of the Shares to the Buyer in accordance with the terms of this Agreement; | |
Completion Accounts | means the Draft Completion Accounts which have been agreed or determined in accordance with Part A of Schedule 4 (Preparation of Completion Accounts); | |
Completion Date | means the date on which Completion occurs; | |
Contingent Consideration | has the meaning given to it in paragraph 1 of Part A of Schedule 5 (Contingent Consideration); | |
Contingent Consideration Loan Notes | means the loan notes which may become issuable by the Buyer to certain of the Sellers following Completion pursuant to clause 3.5 and/or paragraph 2.3 of Schedule 5 (Contingent Consideration), to be constituted by the Loan Notes Instrument; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
3
control | has the meaning given to it in section 1124 of the Corporation Tax Act 2010 and controlling shall be construed accordingly; | |
Declared Distributions | means all dividends and other distributions resolved or declared to be paid or made, by the Company in respect of the Shares by reference to a record date which falls on or before Completion; | |
Defaulting Party | has the meaning given to it in clause 5.4; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
Denali Fcab Notice | has the meaning given to it in the License Agreement; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
Determination Date | means the date on which the Completion Accounts are agreed or determined in accordance with the provisions of Part A of Schedule 4 (Preparation of Completion Accounts); | |
Develop or Development | has the meaning given to it in the License Agreement; | |
Disclosure Documents | means the documents attached to the Disclosure Letter; | |
Disclosure Letter | means the letter from the Warrantors to the Buyer in relation to the Warranties and including the Disclosure Documents having the same date as this Agreement, the receipt of which has been acknowledged by the Buyer; | |
Dispute | has the meaning given to it in clause 23.1; | |
Disputed Business Warranty Claim | means any Business Warranty Claim that is not yet a Settled Business Warranty Claim, and Disputed Business Warranty Claims shall be construed accordingly; | |
Draft Completion Accounts | means a statement of assets and liabilities for the Company as at the Effective Time, in the form and with the line items set out in Part B of Schedule 4 (Completion Accounts) and which has been prepared in accordance with Part A of Schedule 4 (Preparation of Completion Accounts); | |
Effective Time | means 5 p.m. (London time) on the Completion Date; | |
Encumbrance | means a mortgage, charge, pledge, lien, option, restriction, right of first refusal, right of pre-emption, third-party right or interest, other encumbrance or security interest of any kind, or another type of preferential arrangement (including a title transfer or retention arrangement) having similar effect, including any such right or interest arising at Completion or otherwise in connection with this Agreement, and Encumbrances shall be construed accordingly; | |
Escrow Account | means the separately designated interest bearing US dollar deposit account with SunTrust Bank opened by the Escrow Agent and operated in accordance with the Escrow Agreement into which payment of the Escrow Amount will be made by the Buyer at Completion; | |
Escrow Agent | means SunTrust Bank to be appointed pursuant to the Escrow Agreement; | |
Escrow Agreement | means the agreement in the agreed form between the Buyer, the Sellers Representative and the Escrow Agent in relation to the Escrow Account; | |
Escrow Amount | means [***]; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
4
Estimated Net Cash | means such amount in US dollars as is notified in writing by the Sellers to the Buyer no later than 10 Business Days prior to the Completion Date that is the good faith estimate by the Sellers of the Net Cash as at the Effective Time; | |
Exercise Notice | has the meaning given to it in the Option Agreement; | |
Exploitation | has the meaning given to it in the License Agreement; | |
F-star | means F-star Biotechnology Limited, a private limited company incorporated under the laws of England and Wales under company number 08067987, having its registered office at Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT; | |
F-star GmbH | means F-star Biotechnologische Forschungs-und entwicklungsges.m.b.h, a limited liability company incorporated under the laws of the Republic of Austria; | |
Fairly Disclosed | has the meaning given to it in clause 7.5; | |
Fcab Delivery | is defined in Schedule 5 (Contingent Consideration); | |
Fraud Claim | means a claim in respect of fraud, wilful misconduct or wilful concealment by any of Warrantors (individually or on behalf of the Company) prior to Completion; | |
Fundamental Warranty | Means [***] and Fundamental Warranties means [***]; | |
Fundamental Warranty Claim | means a claim by the Buyer for breach of a Fundamental Warranty; | |
Gamma IP License | means that certain license agreement between the Company and F-star dated 24 August 2016; | |
Gamma Service Agreement | means that certain services agreement between the Company and F-star dated 24 August 2016; | |
Guaranteed Obligations | means all present and future payment obligations and liabilities of the Company due, owing or incurred under clause 7.5.2 of the Gamma IP License to F-star (including, without limitation, under any amendment, supplement or restatement of the Gamma IP License; provided such amendment, supplement or restatement shall not increase the obligations of the Buyer without the express consent of the Buyer); | |
HMRC | means HM Revenue & Customs; | |
Indebtedness |
means the aggregate amount (expressed as a positive number) immediately following Completion of the following:
a) the principal and accrued interest on any outstanding borrowing or indebtedness in the nature of borrowing incurred by the Company including, without limitation, bank debt, loans, overdrafts, guarantees of indebtedness, letters of credit (which are secured by a third party), any loan notes or bonds, any other interest bearing and/or secured lending or credit liabilities provided by third parties to the Company and any early repayment, prepayment, or break costs, fees or penalties in respect of any such items and any legal costs and expenses in connection with the release of security in relation to any such borrowings;
b) all deferred indebtedness of the Company for the payment of the purchase price of property or assets purchased or services rendered (other than up to [***] of trade payables and other current liabilities incurred in the ordinary course of business);
c) all obligations of the Company to pay rent or other payment amounts under any lease up to and including the Completion Date;
d) reimbursement obligations of the Company with respect to letters of credit, bankers acceptances or similar facilities issued for the account of the Company and that are outstanding as at the Completion Date;
e) all obligations under any interest rate swap agreement, forward rate agreement, interest rate cap or collar agreement or other financial agreement or arrangement to which the Company is a party and which was entered into for the purpose of limiting or managing interest rate risks,
f) all obligations secured by any Encumbrance existing on property owned by the Company; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5
g) all premiums, penalties, fees, expenses, breakage costs and change of control payments required to be paid or offered in respect of any of the foregoing clauses (b) through (e) as a result of the consummation of the transactions contemplated by this Agreement or in connection with any lender consent;
h) all guaranties, endorsements, assumptions and other contingent obligations of the Company in respect of, or to purchase or to otherwise acquire, any of the obligations and other matters of the kind described in any of the clauses (a) through (g) appertaining to third parties; and
i) all liabilities for Taxes incurred by the Company up to, but not paid by, Completion; |
||
Information | means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed; | |
Initial Amount |
means, where the Buyer serves an Exercise Notice on the Sellers Representative and the Company in accordance with the Option Agreement:
a) on a date prior to both [***];
b) on a date that is [***];
c) on a date that is [***]; or
d) after the time period in paragraph (c) above of this definition, [***]; |
|
Intellectual Property | means all intellectual property rights, whether registered or not, including pending applications for registration of such rights and the right to apply for registration or extension of such rights including patents, petty patents, utility models, design patents, designs, copyright (including moral rights and neighbouring rights), database rights, rights in integrated circuits and other sui generis rights, trade marks, trading names, company names, service marks, logos, the get-up of products and packaging and other signs used in trade, internet domain names, Know How and any rights of the same or similar effect or nature as any of the foregoing anywhere in the world; | |
Know How | means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions; | |
Last Accounting Date | means 31 December of the financial year on which the Companys last audited financial statements and accounts were last required to be filed with the UK Registrar of Companies; | |
License Agreement | means that certain license and collaboration agreement among the Buyer, the Company, F-star GmbH and F-star, dated 24 August 2016; | |
Loan Note Escrow Account | means the separately designated interest bearing US dollar deposit account with SunTrust Bank opened by the Escrow Agent and operated in accordance with the Escrow Agreement into which payment of such amounts as required by clause 3.6 will be made by the Buyer; | |
Loan Note Sellers | each of the Sellers in Schedule 1 marked with an asterisk (*); |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
6
Loan Notes Instrument | means the loan notes instrument to be issued by the Buyer in the agreed form; | |
Management Accounts | means the unaudited monthly management accounts of the Company in respect of the period starting on the day after the Last Accounting Date and ending on the last day of the calendar month preceding the date of this Agreement for which such accounts have been prepared; | |
Material Contract | has the meaning given to it in clause 7.1.1 of Schedule 7; | |
Maximum Contingent Consideration |
means:
a) in the event of a [***], provided that if an Initial Payment True Up Event subsequently occurs, then the Maximum Contingent Consideration will be [***];
b) in the event of a [***], provided that if an Initial Payment True Up Event subsequently occurs, then the Maximum Contingent Consideration will be [***];
c) in the event of a [***]; or
d) in the event of a [***]; |
|
Net Cash | means an amount (which may be a positive or a negative number) equal to the Cash less the Indebtedness, less Transaction Costs and less Declared Distributions; | |
Non-defaulting Party | has the meaning given to it in clause 5.4; | |
Notice | has the meaning given to it in clause 20.1; | |
Option Agreement | means that certain option agreement related to the entire issued share capital of the Company among Buyer, the Company, the Sellers, and the Sellers Representative, dated 24 August 2016; | |
Pass Through Amount | means amounts payable by the Company to F-star pursuant to (i) clause 7.5.2 of the Gamma IP License that have been received by the Company from the Buyer pursuant to the License Agreement but not paid to F-star as of the Completion Date; | |
Payments Administrator | means Acquiom Clearinghouse LLC, a Delaware limited liability company; | |
Payment Date | has the meaning given to it in paragraph 1 of Part A of Schedule 5 (Contingent Consideration); | |
Person | means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
[***] | has the meaning given to it in the definition of Initial Amount; | |
Preliminary Determination Proceeding | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Press Release | means a press release regarding Completion in a form agreed between the Buyer and the Sellers; | |
Proportion of Initial Consideration | has the meaning given to it in clause 3.9; | |
Release Date | means the date which is [***] from Completion; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
7
Relevant Shares | means, in relation to each Seller, the number and class of Shares held as at Completion set out adjacent to that Sellers name in columns B and C of Schedule 1 (The Sellers); | |
Relief | means any loss, relief, exemption, allowance, deduction, credit or set-off in respect of Tax or relevant to the computation of Tax and any right to repayment of Tax; | |
Sellers Majority | means such of the Sellers who, immediately prior to Completion, together held not less than a majority in number of the Shares (as determined by reference to the Shares set out adjacent to each relevant Sellers name in column B of Schedule 1 (The Sellers)); | |
Set Off Claim | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Set Off Dispute Notice | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Set Off Notice | has the meaning given to it in paragraph 11.2 of Schedule 8 (Limitations on Sellers Liability); | |
Settled Business Warranty Claim |
means a Business Warranty Claim or part of a Business Warranty Claim the quantum of which is:
a) agreed in writing between the Buyer and the Sellers Representative;
b) determined by [***] court of competent jurisdiction; or
c) determined pursuant to the procedures set forth in clause 23.3; |
|
Settled Claim |
means a Settled Business Warranty Claim, or a Special Indemnity Claim, Fundamental Warranty Claim, or Warrantor Fundamental Warranty Claim (or part thereof), the quantum of which is:
a) agreed in writing between the Buyer and the Sellers Representative;
b) determined by [***] court of competent jurisdiction; or
c) determined pursuant to the procedures set forth in clause 23.3; |
|
Shareholders Agreement | means the shareholders agreement between the Shareholders and the Company dated 24 August 2016; | |
Shareholder Arrangements | means any advisory, contractual or commercial arrangements relating to the Company (including the existing shareholders agreement relating to the Company) to which any or all of the Sellers and/or any of their Affiliates are a party (excluding any employment agreement or consultancy agreement between those Sellers who are employees or consultants and the Company); | |
Shares | means all of the issued ordinary shares in the capital of the Company from time to time; | |
Shortfall | has the meaning given to it in clause 5.1(a); | |
[***] | has the meaning given to it in clause 6.3; | |
Special Indemnity Claim | means a claim in respect of any of the Special Indemnity Matters and Special Indemnity Claims shall be construed accordingly; | |
Special Indemnity Matter | means [***] and Special Indemnity Matters means [***]; | |
Tax, Taxes or Taxation | means all forms of taxation, duties and withholdings in respect of taxation imposed in the United Kingdom or elsewhere (including National Insurance contributions) and all interest, penalties, charges and fines in respect of any of them; | |
Tax Authority | means HMRC and any other authority, body or official (whether in the United Kingdom or elsewhere) competent to assess, demand, impose, administer or collect Tax or make any decision or ruling on any matter relating to Tax; | |
Tax Warranty | means [***] and Tax Warranties means [***]; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Tax Warranty Claim | means a claim in respect of any breach of any of the Tax Warranties; | |
Third Party | has the meaning given to it in the License Agreement; | |
Total Consideration | has the meaning given to it in clause 3.1; | |
Total Contingent Consideration | has the meaning given to it in paragraph 1 of Part A of Schedule 5 (Contingent Consideration); | |
Transaction Costs | means all third party fees, costs, expenses, payments, and expenditures incurred by the Company in connection with the transactions contemplated by this Agreement whether or not billed or accrued (including any fees, costs expenses, payments, and expenditures of legal counsel and accountants, the maximum amount of fees costs, expenses, payments, and expenditures payable to financial advisors, investment bankers and brokers of the Company notwithstanding any contingencies for earnouts, escrows, etc., and any such fees, costs, expenses, payments, and expenditures incurred by the Sellers paid for or to be paid for by the Company); | |
Transaction Documents | means this Agreement, the Option Agreement, the License Agreement, the Gamma IP License, the Loan Note Instrument, the Disclosure Letter, the Escrow Agreement and the Gamma Service Agreement; | |
Upfront Consideration | has the meaning given to it in clause 3.2; | |
Warrantor Fundamental Warranties | means [***]; | |
Warrantor Fundamental Warranty Claim | means a claim by the Buyer for breach of a Warrantor Fundamental Warranty; | |
Warrantors | means [***], save that if any such person ceases to be employed or otherwise engaged by F-star GmbH (or any of its Affiliates) in a management position or ceases to own (legally or beneficially) Shares then they shall cease to be a Warrantor and shall be replaced as a Warrantor by the person then performing the role of [***], or, in any case, by such person as the Company, acting reasonably, may nominate in writing provided that such person owns Shares (legally or beneficially), performs a senior management role in the Company and the Buyer consents to the appointment, such consent not to be unreasonably withheld, conditioned or delayed, and a Warrantor means any one of them; and | |
Warranty | means [***] and Warranties means [***]. |
1.2. |
Clause, Schedule and paragraph headings shall not affect the interpretation of this Agreement. |
1.3. |
References to clauses and Schedules are to the clauses and Schedules of this Agreement and references to paragraphs are to paragraphs of the relevant Schedule. |
1.4. |
The Schedules form part of this agreement and shall have effect as if set out in full in the body of this Agreement. Any reference to this agreement includes the Schedules. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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1.5. |
A subsidiary or holding company is to be construed in accordance with section 1159 (and Schedule 6) of the Companies Act and a subsidiary undertaking or parent undertaking is to be construed in accordance with section 1162 (and Schedule 7) of the Companies Act; |
1.6. |
A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality). |
1.7. |
A reference to a party shall include that partys personal representatives, successors and permitted assigns. |
1.8. |
Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular. |
1.9. |
Unless the context otherwise requires, a reference to one gender shall include a reference to the other genders. |
1.10. |
A reference to writing or written includes fax and e-mail (unless otherwise expressly provided in this Agreement). |
1.11. |
The ejusdem generis principle of construction shall not apply to this Agreement. Accordingly, any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms. Where the context permits, other and otherwise are illustrative and shall not limit the sense of the words preceding them. |
1.12. |
A reference to a document in this Agreement in the agreed form is to a document agreed by the parties and initialled by them or on their behalf for identification purposes. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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1.13. |
Where any obligation in this Agreement is expressed to be undertaken or assumed by any party, that obligation is to be construed as requiring the party concerned to exercise all rights and powers of control over the affairs of any other person which it is able to exercise (whether directly or indirectly) in order to secure performance of the obligation. |
1.14. |
References to any English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any other legal concept shall, in respect of any jurisdiction other than England, be deemed to include the legal concept which most nearly approximates in that jurisdiction to the English legal term. |
1.15. |
A reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time. |
1.16. |
References to US$ or $ are references to US dollars, legal tender in the United States, and references to GBP or £ are references to pounds sterling, legal tender in the United Kingdom. |
2. |
SALE AND PURCHASE |
2.1. |
Each Seller severally agrees to sell or procure the sale to the Buyer, and the Buyer agrees to buy, all of such Sellers Relevant Shares together with all rights attaching to those Relevant Shares at Completion, free from any Encumbrance and with full title guarantee. |
2.2. |
Each Seller severally waives all rights of pre-emption, rights of first refusal and any other similar rights or other restrictions on transfer conferred on that Seller by the Companys articles of association or otherwise over any of the Relevant Shares. |
2.3. |
The Buyer shall be responsible for the payment of all stamp duty (and, if applicable, stamp duty reserve tax) on this Agreement and the transfers in respect of the Shares at Completion. |
2.4. |
In the event that the Buyer becomes aware that it or the Escrow Agent will have an obligation to deduct or withhold an amount for or on account of Taxes from any |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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payment made under this Agreement, it shall notify the Sellers Representative in writing as soon as reasonably practicable and the parties shall use their reasonable endeavours to do, to the extent within their power and authority, all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement, treaty or domestic exemption which may apply to eliminate or reduce withholding Taxes and otherwise provide the Sellers such assistance as is reasonably required to obtain a refund of the withheld or similar Taxes, or obtain a credit with respect to such Taxes. In the event there is no applicable double taxation agreement, treaty or domestic exemption or if an applicable double taxation agreement, treaty or domestic exemption reduces but does not eliminate such withholding or similar Tax, the Buyer or Escrow Agent shall deduct the amount paid from the amount due to the respective Seller or Sellers, remit such withholding or similar Tax to the appropriate Tax Authority and secure and send to the respective Seller or Sellers reasonable evidence of the payment of such withholding or similar Tax. In the event that any Taxes are required by applicable Tax law to be withheld or deducted for or on account of Tax from any payments made under this Agreement, any Taxes so withheld and deducted from any payment by the Buyer or the Escrow Agent and paid over to the appropriate Tax Authority shall be treated as paid to the Sellers under this Agreement. |
3. |
CONSIDERATION |
3.1. |
The purchase price for the Shares shall be an amount equal to: |
(a) |
the Upfront Consideration; and |
(b) |
any Contingent Consideration, |
(collectively, the Total Consideration).
Upfront Consideration
3.2. |
The aggregate consideration payable by the Buyer to the Sellers for the Shares pursuant to this Agreement on the Completion Date shall be: |
(a) |
the Initial Amount; plus |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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(b) |
the Estimated Net Cash, |
(the amount set out in clause 3.2(a) plus the amount set out in clause 3.2(b) being the Initial Consideration), as increased by the amount to be paid by the Buyer or, as the case may be, decreased by the amount to be paid by the Sellers, pursuant to clause 4.1 (the total sum being referred to as the Upfront Consideration).
3.3. |
At Completion, the Buyer shall pay: |
(a) |
an amount in cash equal to the Initial Consideration less the Escrow Amount, by transfer of funds for same day value to the Payments Administrator in accordance with clause 13.1; and |
(b) |
the Escrow Amount into the Escrow Account by transfer of funds for same day value. |
3.4. |
The parties agree to comply with their respective obligations under Part A of Schedule 4 (Preparation of Completion Accounts). |
Contingent Consideration
3.5. |
If any of the Milestone Events set forth in Schedule 5 (Contingent Consideration) are achieved, the Buyer will make the corresponding Milestone Payment to the Payments Administrator for further distribution to the Sellers on or prior to the Payment Date. Any Contingent Consideration payable to the Sellers shall be allocated between the Sellers with regard to their respective Proportion of Initial Consideration or as otherwise notified to the Buyer in writing by the Sellers Representative at least five (5) Business Days prior to a Payment Date and shall be satisfied: |
(a) |
in respect of the Loan Note Sellers, by the issue by the Buyer of the Contingent Consideration Loan Notes to each of the Loan Note Sellers equal, in principal amount, to the relevant Contingent Consideration due to such Loan Note Sellers; and |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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(b) |
in respect of the Cash Sellers, by paying the relevant Contingent Consideration due to each of the Cash Sellers to the Payments Administrator in accordance with clause 13 on a Payment Date. |
3.6. |
Simultaneously with the issue by the Buyer of any Contingent Consideration Loan Notes to the Loan Note Sellers in accordance with clause 3.5(a), the Buyer shall transfer to the Loan Note Escrow Account an amount equal to the total aggregate principal amount of such Contingent Consideration Loan Notes, which amount (together with any interest accrued thereon) shall be released by the Escrow Agent to the Loan Note Sellers within five (5) Business Days following redemption of such Contingent Consideration Loan Notes in accordance with the Loan Note Instrument. The Escrow Agent may withdraw from the Loan Note Escrow Account an amount equal to any Tax on the interest earned in respect of money held in the Loan Note Escrow Account for which it is liable. |
3.7. |
The Total Contingent Consideration shall not under any circumstances exceed the Maximum Contingent Consideration. |
3.8. |
The Buyer shall (and shall procure that all relevant Buyers Group Undertakings shall) comply with the provisions of Schedule 5 (Contingent Consideration). |
3.9. |
The proportion of the Initial Consideration, to which each Seller is entitled is set against his name in column D of Schedule 1 (The Sellers) (each, a Proportion of Initial Consideration). |
Consideration Generally
3.10. |
Each Seller agrees to the allocation of the Total Consideration as provided for in this Agreement (including any allocation notified to the Buyer by the Sellers Representative pursuant to clause 3.5) and waives any claim or dispute regarding the apportionment of the proceeds from the sale of his Shares provided it is made in accordance with this Agreement. Following any payment to the Payments |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Administrator in accordance with this Agreement, the Buyer shall be under no obligation to see that any such amounts are divided and paid to each Seller (or any other person). |
3.11. |
If, after Completion, any Seller is in or comes into possession of any amounts attributable to any other Seller then as soon as reasonably practicable following any request by the Seller which has the right to such amounts, the relevant Seller shall use all reasonable endeavours to ensure that the person in possession of that relevant amount does or causes to be done all such things as the Seller entitled to such amount may from time to time reasonably require, in order to transfer possession of such relevant amount to the owner. |
4. |
POST COMPLETION ADJUSTMENTS |
4.1. |
If the amount of the Actual Net Cash: |
(a) |
is less than the amount of the Estimated Net Cash, then, subject to clause 5.3, the Sellers shall pay the Buyer an amount equal to the amount of such shortfall (the Shortfall); or |
(b) |
exceeds the amount of the Estimated Net Cash, the Buyer shall pay the Sellers an amount equal to the amount of such excess, |
in either case, together with an amount equal to interest on such sum calculated on a daily basis at a rate of [***] from (and including) the Completion Date to (but excluding) the date of actual payment, in accordance with the provisions of clauses 4.2 and 4.3.
4.2. |
Payments made by the Buyer pursuant to clause 4.1(b) shall be made by transfer of funds for same day value (to the Payments Administrator in accordance with clause 13.1), within two (2) Business Days of the Determination Date without set off, deduction or withholding (except as required by law or by this Agreement). |
4.3. |
If an amount is payable by the Sellers pursuant to clause 4.1(a), such amount shall be paid from the Escrow Account to the Buyer when the Buyer and the Sellers Representative within |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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two (2) Business Days of the Determination Date jointly instruct the Escrow Agent in writing to make such payment out of amounts standing to the credit of the Escrow Account to the Buyers Account in accordance with clause 13.2. |
5. |
COMPLETION |
5.1. |
Completion shall take place at the offices of the Sellers Solicitors immediately following the execution of this Agreement. |
5.2. |
At Completion each Seller and the Buyer shall do all those things respectively required of each of them in Schedule 3 (Completion Requirements). |
5.3. |
Neither the Sellers nor the Buyer are obliged to complete this Agreement unless: |
(a) |
all of the Sellers (in the case of the Buyer) or the Buyer (in the case of the Sellers) comply with all its/their obligations under this clause 5 and Schedule 3 (Completion Requirements); and |
(b) |
subject to the provisions of clause 7 of the Option Agreement, the purchase of all the Shares under this Agreement is completed simultaneously. |
5.4. |
If Completion does not take place immediately following the execution of this Agreement because the Buyer or any Seller (the Defaulting Party) fails to comply with any of its obligations under this clause 5 and Schedule 3 (Completion Requirements) (whether such failure amounts to a repudiatory breach or not) (a Material Default), the Buyer (if the Defaulting Party is a Seller) or the Company (if the Defaulting Party is the Buyer) (the Non-defaulting Party) may by notice to the Defaulting Party: |
(a) |
proceed to Completion to the extent reasonably practicable (without limiting its rights under this Agreement); |
(b) |
postpone Completion to such date as the Non-defaulting Party may specify; or |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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(c) |
terminate this Agreement by notice in writing to the Defaulting Party (a Termination Notice) save that the Non-defaulting Party shall have five (5) Business Days from receipt of the Termination Notice to remedy such Material Default (provided, however, that no such cure period shall be available or applicable to any such Material Default which by its nature cannot be cured). In the event that the Material Default is capable of being remedied but is not so remedied within the requisite time period, this Agreement shall terminate upon expiry of the period of five (5) Business Days without further action by either party. If the Material Default is remedied within the requisite time, the Termination Notice shall lapse and Completion shall be deemed to have been postponed until such date as the Non-defaulting Party may determine. |
5.5. |
If the Non-defaulting Party postpones Completion to another date in accordance with clause 5.4(b), or if Completion is deemed to have been postponed to another date in accordance with clause 5.4(c), the provisions of this Agreement apply as if that other date is the Completion Date. |
5.6. |
If the Non-defaulting Party terminates this Agreement pursuant to clause 5.4(c), each partys further rights and obligations cease immediately on termination, but termination does not affect a partys accrued rights and obligations at the date of termination. |
5.7. |
The parties agree that except in the case of fraud, wilful misconduct or wilful concealment on behalf of the Sellers or the Buyer, rescission shall not be available as a remedy for any breach of this Agreement. |
5.8. |
Nothing in this clause 5 shall prevent a Non-defaulting Party from exercising remedies available to it under applicable law. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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6. |
ESCROW ACCOUNT |
6.1. |
Each party agrees that the money in the Escrow Account shall only be used in accordance with the provisions set out in clause 4, this clause 6, paragraph 5 of Part A of Schedule 4 (Preparation of Completion Accounts) and the Escrow Agreement. |
6.2. |
Each party shall ensure that all rights to the Escrow Account remain free from any Encumbrance, set off or counterclaim except as referred to in this clause 6. |
6.3. |
The liability of any Warrantor in respect of [***] shall be limited by the amount of money standing to the credit of the Escrow Account from time to time and the sole remedy of the Buyer under this Agreement in respect of a [***] shall be the release of any such amount to the Buyer from the Escrow Account. |
6.4. |
A [***] must be satisfied out of and deducted from the money in the Escrow Account in accordance with this clause 6 and a Shortfall must be first satisfied out of and deducted from the money in the Escrow Account in accordance with this clause 6. In addition, in the event of [***]. |
6.5. |
To the extent that liability for [***] is to be satisfied from the Escrow Account, each Warrantor shall be [***] liable to the Buyer for such liability up to the availability of any amount standing to the credit of the Escrow Account from time to time irrespective of the amount (if any) contributed to the Escrow Account by such Warrantor. |
6.6. |
No Warrantor shall have any liability to any other Seller in respect of any liability satisfied from the Escrow Account. |
6.7. |
Clauses 6.3 and 6.6 shall not apply so as to limit the liability of any Warrantor in respect of any fraud by such Warrantor or any remedy available to any other Seller or the Buyer in respect thereof. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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6.8. |
Interest accruing from time to time on the balance of money standing to the credit of the Escrow Account shall be added to the money standing to the credit of the Escrow Account and shall form part of it for the purposes of this clause 6. |
6.9. |
All of the costs (including reasonable legal costs) and expenses (together with any applicable VAT), in each case, of any nature whatsoever, of the Escrow Agent in relation to the Escrow Account and the Escrow Agreement shall be deemed to be Transaction Costs. |
6.10. |
The Escrow Agent may withdraw from the Escrow Account an amount equal to any Tax on the interest earned in respect of money held in the Escrow Account for which it is liable. |
6.11. |
On the Release Date, the money then standing to the credit of the Escrow Account less the total of the then outstanding Disputed Business Warranty Claims and less any amount that has not yet been paid in accordance with clause 4 or paragraph 5 of Part A of Schedule 4 (Preparation of Completion Accounts) shall be paid to the Payments Administrator in accordance with clause 13.1. After that date, to the extent that the money standing to the credit of the Escrow Account from time to time exceeds the total of the then outstanding Disputed Business Warranty Claims and any amount that has not yet been paid in accordance with clause 4 or paragraph 5 of Part A of Schedule 4 (Preparation of Completion Accounts), that money shall be paid to the Payments Administrator in accordance with clause 13.1. |
6.12. |
If the Sellers or the Buyer are entitled to money from the Escrow Account under clauses 6.4 or 6.11, the Sellers Representative and the Buyer shall within five (5) Business Days of the date on which the entitlement arises jointly instruct the Escrow Agent in writing to release the money to the Payments Administrator in accordance with clause 13.1 or the Buyer, as the case may be, together with an amount (less any Tax and other amount the Escrow Agent is legally required to deduct from that amount) equal to the interest actually accrued on such sum calculated for the period from (and including) the date of this Agreement to (but excluding) the date of payment. |
6.13. |
All payments made to the Buyer by the Escrow Agent under this clause 6 shall be made gross and without deduction or withholding of any kind other than any deduction or withholding required by law. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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6.14. |
The amount, if any, of the Escrow Amount which is paid to the Buyer pursuant to clause 4.2 or this clause 6 shall be treated as a reduction in the Total Consideration. |
6.15. |
The Sellers agree between themselves that any amounts released to the Payments Administrator for further distribution to the Sellers from the Escrow Account shall be apportioned between them by reference to their respective contribution initially made to the Escrow Amount (as set out in column F of the table in Schedule 1 (The Sellers). |
7. |
SELLER WARRANTIES AND INDEMNITY |
7.1. |
Each Seller (i) [***] warrants [***] to the Buyer in the terms of the Fundamental Warranties at Completion and, subject to clause 7.4, the Tax Warranties at Completion; and (ii) subject to the limitations set forth in Schedule 8 (Limitations on the Sellers Liability) agrees [***], and on a pro rata basis in accordance with each Sellers Proportion of Initial Consideration, to indemnify the Buyer against any losses, costs, claims, liabilities, damages, demands and expenses arising out of any Special Indemnity Matter save where such losses, costs, claims, liabilities, damages, demands and/or expenses are a result of any action or omission by or on behalf of the Buyer (or any Buyers Group Undertaking) or due to the Buyers (or any Buyers Group Undertakings) gross negligence, wilful misconduct or wilful concealment. |
7.2. |
Each Warrantor [***] warrants [***] to the Buyer in the terms of the Warrantor Fundamental Warranties at Completion. |
7.3. |
Subject to clause 7.4, each Warrantor [***] warrants to the Buyer on the terms of the Business Warranties at Completion. |
7.4. |
[***]. For the avoidance of doubt, [***]. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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7.5. |
[***]. |
7.6. |
Where [***] is qualified by the expression so far as the Warrantors are aware or to the best of the knowledge, information and belief of the Warrantors or qualified by any similar expression, each Warrantor shall be deemed only to have knowledge of anything of which [***]. |
7.7. |
Each Seller agrees and undertakes to the Buyer and to each person referred to in this clause 7.7 that, except in the case of fraud, it will not make any claim against the Company or any director, officer or employee of the Company on whom it may have relied before agreeing any term of this Agreement or any of the transaction contemplated by this Agreement which it may have in respect of a misrepresentation, inaccuracy or omission in or from information or advice provided by any such person for the purpose of assisting any such Seller to make a representation, give a Warranty or prepare the Disclosure Letter (as applicable). After |
Completion, the Company or any director, officer or employee of the Company may enforce the terms of this clause 7.7 subject to and in accordance with [***].
7.8. |
[***]. |
8. |
LIMITATIONS TO THE SELLERS LIABILITY |
8.1. |
Each Sellers liability for [***] and each Warrantors liability for [***] shall be limited or excluded, as the case may be, as set out in clause 7 and Schedule 8 (Limitations on the Sellers Liability). |
8.2. |
Except as stated in this Agreement, the Buyer shall not be restricted from including as part of any Claim any losses, costs, claims, liabilities, damages, demands and/or expenses [***]. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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9. |
BUYERS WARRANTIES |
The Buyer warrants to each Seller as at Completion that:
9.1. |
it is a company duly incorporated and validly existing in the State of Delaware, United States and has the right, power and authority to execute, deliver and perform its obligations under this Agreement and any other Transactional Document to be executed by it; |
9.2. |
the Buyers obligations under this Agreement and any other Transactional Documents to be executed by the Buyer are, or when the relevant document is executed will be, enforceable in accordance with their terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors rights generally and general equitable principles; |
9.3. |
the execution, delivery and performance by the Buyer of this Agreement and each Transactional Document to be executed by it will not breach any provision of the certificate of incorporation or bylaws of the Buyer or breach any applicable laws or regulations, or any orders, judgements or decrees which the Buyer is bound by or result in a breach of or constitute a default under any instrument, contract or agreement to which the Buyer is a party or by which the Buyer is bound and which, in each case, is material in the context of the transactions contemplated by this Agreement and any of the Transactional Documents; and |
9.4. |
it has available on an unconditional basis (subject only to Completion) the necessary resources to meet its obligations under this Agreement, other than payment of the Contingent Consideration. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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10. |
POST COMPLETION MATTERS |
10.1. |
Each Seller agrees in respect only of itself that the Seller shall, for so long as the Seller remains the registered holder of any of the Relevant Shares after Completion, hold those Relevant Shares with all rights and benefits attaching or accruing to them on or after the date of this Agreement as bare trustee for the Buyer absolutely. |
10.2. |
For a period of [***] after Completion each Seller hereby irrevocably undertakes to the Buyer pending registration by the Company of the transfer of the Sellers Relevant Shares to the Buyer, to exercise any votes attaching to any of the Sellers Relevant Shares or sign any consent to short notice of a general meeting (or written resolution in lieu thereof) as the Buyer may reasonably direct. |
10.3. |
Each Seller acting severally shall execute and shall procure the execution of, all documents and deeds and/or do or procure the doing of, all acts and things that the Buyer reasonably requires after Completion to vest in the Buyer legal title to and the full benefit of the Relevant Shares held by such Seller. |
10.4. |
Subject to clause 10.5, each of the Sellers (for itself and for and on behalf of each of its Affiliates) hereby irrevocably agrees that, with effect from and conditional upon Completion: |
(a) |
the Shareholder Arrangements are hereby terminated; |
(b) |
any and all rights of any Seller and/or any of its Affiliates and any and all obligations of the Company under, pursuant to or in connection with the Shareholder Arrangements, along with any other claim or demand of any Seller or any of its Affiliates against the Company, which are subsisting or outstanding at the date of this Agreement are expressly waived and released, including any and all such rights and obligations, claims and demands which may have accrued in respect of any period prior to Completion; and |
(c) |
any and all other debts or liabilities (whether actual, contingent or prospective and including any interest thereon) of the Company to any Seller under, pursuant to or in connection with the Shareholder Arrangements or otherwise which are subsisting or outstanding at the date of this Agreement are expressly waived, released and discharged. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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10.5. |
Each Seller shall ensure that at Completion there will be no amounts owing by the Company to such Seller in respect of itself and its Affiliates only, other than by way of accrued but unpaid salary or consultancy fees or unreimbursed expenses incurred in the ordinary course of business consistent with past practice owed to employees or consultants of the Company. |
10.6. |
The Buyer shall, within 20 Business Days of Completion, procure that the name of the Company is changed to such name as the Buyer may decide provided that it does not include the word F-star. |
10.7. |
The Buyer intends to make an election under Section 338(g) of the United States Internal Revenue Code of 1986, as amended (the IRC) (and any corresponding election under state and local Tax law) with respect to the purchase of the Shares under this Agreement (collectively, the Section 338 Election). The Buyer may make the Section 338 Election in its sole discretion; provided, however, that the Sellers shall not be liable in respect of a Tax Warranty Claim for any liability of the Company for Taxes arising directly or indirectly from the Section 338 Election and the Buyer shall indemnify the Sellers and the Company on an after-Tax basis against any Tax liability, losses and all reasonable costs and expenses of the Sellers or the Company which arise directly or indirectly as a result of the Section 338 Election being made excluding any Tax liability, losses or costs and expenses that would have not have arisen had all of the Tax Warranties made by the Company and Sellers been true, correct and complete. In addition, in the case of any Seller, the calculation of any increase in Tax liability of such Seller resulting from the Section 338 Election shall be made assuming (a) that such Seller and any of its direct or indirect owners has made a timely and valid election under Section 1295 of the U.S. Internal Revenue Code of 1986, as amended (the Code) and the regulations thereunder to treat its shares in the Company as a qualified electing fund within the meaning of Section 1295 effective with the first day of such Sellers holding period in the Companys shares and (b) that the Company is not, and has not at any time during the five (5) taxable years preceding the Completion Date, been a controlled foreign corporation within the meaning of Section 957 of the IRC. For clarify, Purchaser shall not be required under |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
24
this Section 10.7 to indemnify the Company or any Seller for any Tax liability that would not have arisen had a Seller (or its direct or indirect owners) elected to treat the Company as a qualified electing fund and/or had the Company not been a controlled foreign corporation, as described in the previous sentence. |
11. |
BUYER GUARANTEE |
11.1. |
Following Completion, the Buyer guarantees to F-star, whenever the Company does not pay any of the Guaranteed Obligations when due, to pay within 5 Business Days following receipt of written demand from F-star, the Guaranteed Obligations. |
11.2. |
Following Completion, the Buyer as principal obligor and as a separate and independent obligation and liability from its obligations and liabilities under clause 11.1 agrees to indemnify and keep indemnified F-star in full and on written demand from and against all and any losses, costs, claims, liabilities, damages, demands and expenses suffered or incurred by F-star arising directly out of the Guaranteed Obligations not being recoverable for any reason or any failure of the Company to pay any of its obligations or liabilities in respect of the Guaranteed Obligations. |
11.3. |
This guarantee is and shall cover the ultimate balance from time to time owing to F-star by the Company in respect of the Guaranteed Obligations. |
11.4. |
The liability of the Buyer under this clause 11 shall not be terminated by: |
(a) |
any intermediate payment, settlement of account or discharge in part of the Guaranteed Obligations; |
(b) |
any variation, extension, discharge, compromise, dealing with, exchange or renewal of any right or remedy which F-star may now or after the date of this guarantee have from or against any of the Company and any other person in connection with the Guaranteed Obligations; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
25
(c) |
any amendment, variation, novation, replacement or supplement of or to any of the Guaranteed Obligations; |
(d) |
any grant of time, indulgence, waiver or concession to the Company or any other person; |
(e) |
any insolvency, bankruptcy, liquidation, administration, winding up, incapacity, limitation, disability, the discharge by operation of law, or any change in the constitution, name or style of the Company, F-star, or any other person; |
(f) |
any claim or enforcement of payment from the Company or any other person; or |
(g) |
any act or omission which would not have discharged or affected the liability of the Buyer had it been a principal debtor instead of a guarantor, or indemnifier or by anything done or omitted by any person which, but for this provision, might operate to exonerate or discharge the Buyer or otherwise reduce or extinguish its liability under this guarantee. |
11.5. |
Any release, discharge or settlement between the Buyer and F-star in relation to this guarantee shall be conditional on no right, disposition or payment to F-star by the Buyer, the Company or any other person in respect of the Guaranteed Obligations being avoided, set aside or ordered to be refunded under any enactment or law relating to breach of duty by any person, bankruptcy, liquidation, administration, protection from creditors generally or insolvency or for any other reason. |
11.6. |
If any right, disposition or payment referred to in clause 11.5 is avoided, set aside or ordered to be refunded, F-star shall be entitled subsequently to enforce this guarantee against the Buyer as if such release, discharge or settlement had not occurred and any such right, security, disposition or payment had not been given or made. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
26
11.7. |
F-star shall be entitled to enforce this clause 11 against the Buyer as if it were a party to this Agreement. |
12. |
SELLERS REPRESENTATIVE |
12.1. |
Each Seller hereby irrevocably and unconditionally appoints the Sellers Representative as sole representative agent and attorney-in-fact to act on such Sellers behalf for all purposes relating to this Agreement after Completion and each agreement and document ancillary thereto, including for the purposes of: |
(a) |
accepting and giving notices on behalf of such Seller; |
(b) |
making elections and granting any consent or approval on behalf of such Seller under this Agreement; |
(c) |
approving and executing any document on behalf of such Seller to give effect to the release of any money then standing to the credit of the Escrow Account; |
(d) |
defending, negotiating, compromising, settling and releasing on behalf of such Seller any rights and claims (including legal proceedings) which the Buyer may threaten or pursue in respect of any breach of, or right under, this Agreement or any other Transactional Document; |
(e) |
confirming the allocation between the Sellers of the Contingent Consideration to be made under this Agreement; |
(f) |
enforcing, negotiating, compromising, settling and releasing on behalf of such Seller any rights and claims (including legal proceedings and ADR) which he may have, threaten or pursue against the Buyer (or any other person) in respect of any breach of, or right under, this Agreement or any other Transactional Document or any Dispute; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
27
(g) |
consent or agree to any amendment to this Agreement or to waive any terms and conditions of this Agreement providing rights or benefits to the Sellers (other than with respect to the payment of the Total Consideration) in accordance with the terms hereof and in the manner provided herein; |
(h) |
taking any and all actions that may be necessary or desirable in connection with the payment by the Sellers of the costs and expenses incurred under this Agreement; and |
(i) |
generally taking any and all other actions and doing any and all other things provided in or contemplated by this Agreement and each agreement and document ancillary thereto to be performed by such Seller or the Sellers Representative. |
12.2. |
Each Seller hereby irrevocably (by way of security for the performance of his obligations under this Agreement) appoints the Sellers Representative as its agent with full authority on his behalf and in the Sellers name, as applicable, or otherwise, to do all acts and to execute and deliver such documents or deeds as are required by law or as may, in the reasonable opinion of the Sellers Representative, be required or convenient to give effect to the matters described in clause 12.1. |
12.3. |
The Sellers Representative shall act in good faith in accordance with what the Sellers Representative believes to be the best interests of the Sellers when exercising any power or authority conferred on under this clause 12. |
12.4. |
Save in the event of fraud, any action undertaken or omitted by the Sellers Representative with the written approval of a Sellers Majority shall be conclusively deemed to be in accordance with the requirements of clause 12.3 provided that, for the avoidance of doubt, such approval shall not be necessary. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
28
12.5. |
The Sellers Representative may resign at any time. The Sellers Representative may consult with any Seller to the extent a claim is threatened or pursued by the Buyer in respect of any breach of, or right under, this Agreement or any other Transactional Document and which specifically concerns any actual or alleged act or default of that Seller. |
12.6. |
The Sellers may, by written notice signed by a Sellers Majority (a Change Of Sellers Representative Notice), replace a resigning Sellers Representative or remove an incumbent Sellers Representative from such position and appoint another person to act as Sellers Representative in substitution thereof (a New Sellers Representative). A Change Of Sellers Representative Notice shall be effective only once a copy thereof has been served on both the incumbent Sellers Representative and the Buyer. |
12.7. |
A New Sellers Representative so appointed shall, with effect from the time of its appointment, execute a deed of adherence in favour of the Sellers and the Buyer pursuant to which it shall agree to adhere to, and be bound by, this Agreement as though named herein as the Sellers Representative and the parties agree that such substitute New Sellers Representative shall be conferred the rights, power and authorities (including as set out in this clause 12) of the Sellers Representative as set out in this Agreement and entitled to directly enforce the same (notwithstanding that it may not have initially been a signatory hereto). A copy of such deed of adherence shall be delivered to the Buyer at the same time as the Change Of Sellers Representative Notice is served thereon under clause 12.6. |
12.8. |
If at any time a New Sellers Representative is appointed in accordance with clause 12.6, if required by the Buyer, the Sellers Representative hereby undertakes to do all such things as may be necessary to novate the Escrow Agreement from the previous Sellers Representative to the New Sellers Representative. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
29
12.9. |
Any action taken or any exercise of powers under this Agreement by the Sellers Representative or any New Sellers Representative shall be binding on each Seller for the purposes of this Agreement, shall be deemed to be done by each Seller, and the Buyer shall be entitled to assume that any action taken by the Sellers Representative or any New Sellers Representative whose appointment has been notified in accordance with this clause 14 is binding on all of the Sellers and the parties shall be entitled to rely on the same. The Buyer shall not be required to make further enquiries in respect thereof. The Buyer shall have no obligation to monitor or supervise the Sellers Representative or any New Sellers Representative. The Buyer shall not be liable to any of the Sellers for any action taken or omitted to be taken by the Sellers Representative or any New Sellers Representative. |
12.10. |
All costs (including legal costs) and expenses (including Tax), in each case, of any nature whatsoever, of the Sellers Representative shall be borne by the Sellers in the proportions set out in column D of the table in Schedule 1 (The Sellers). |
12.11. |
The Sellers Representative shall have no liability or obligation to take any action on behalf of any Seller under the powers and authorities conferred on the Sellers Representative by this Agreement where such action may result in the Sellers Representative incurring any cost, expense or liability unless the Sellers Representative is satisfied with any arrangements made by (or on behalf of) the Sellers for the satisfaction or re-imbursement of such costs, expenses and liabilities. |
12.12. |
Upon Completion, and subject to receipt by the Sellers Representative of the cash sum provided for in clause 3.3(a), the Sellers Representative will retain an amount of [***] from such sum (the Expense Fund), which will be used for the purposes of paying directly, or reimbursing the Sellers Representative for, any third party expenses pursuant to this Agreement and the transactions contemplated hereby. The Sellers will not receive any interest or earnings on the Expense Fund and irrevocably transfer and assign to the Sellers Representative any ownership right that they may otherwise have had in any such interest or earnings. The Sellers Representative will not be liable for any loss of principal of the Expense Fund other than as a result of its gross negligence or wilful misconduct. The Sellers Representative will hold these funds separate from its corporate funds in a segregated client account, will not use these funds for its operating expenses or any other corporate purposes and will not voluntarily make these funds available to its creditors in the event of bankruptcy. As soon as practicable following the completion of the Sellers Representatives |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
30
responsibilities, the Sellers Representative will distribute the balance of the Expense Fund to the Payments Administrator for further distribution to the Sellers. For tax purposes, the Expense Fund shall be treated as having been received and voluntarily set aside by the Sellers at the time of Completion. The parties agree that the Sellers Representative is not responsible for any tax withholding or reporting or acting as a withholding agent or in any similar capacity in connection with the Expense Fund. |
12.13. |
The Sellers Representative will incur no liability of any kind with respect to any action or omission by the Sellers Representative in connection with Sellers Representatives services pursuant to this Agreement and any agreements ancillary hereto, except in the event of liability directly resulting from the Sellers Representatives gross negligence or wilful misconduct. The Sellers Representative shall not be liable to any Seller as a result of any action or omission that is taken (or not taken) in good faith pursuant to the advice of external legal counsel in the proper performance of its obligations under this Agreement. The Sellers will, severally and not jointly, on a pro rata basis equal to the portion of Total Consideration each such Seller is entitled to receive pursuant to this Agreement compared to the aggregate Total Consideration entitled to be received by all Sellers, indemnify, defend and hold harmless the Sellers Representative from and against any and all losses, liabilities, damages, claims, penalties, fines, forfeitures, actions, fees, costs and expenses (including the fees and expenses of counsel and experts and their staffs and all expense of document location, duplication and shipment) (collectively, Representative Losses) arising out of or in connection with the Sellers Representatives execution and performance of this Agreement and any agreements ancillary hereto, in each case as such Representative Loss is suffered or incurred; provided, that in the event that any such Representative Loss is finally adjudicated to have been directly caused by the gross negligence or wilful misconduct of the Sellers Representative, the Sellers Representative will reimburse the Sellers the amount of such Representative Loss to the extent attributable to such gross negligence or wilful misconduct. If not paid directly to the Sellers Representative by the Sellers, any such indemnified Representative Losses may be recovered by the Sellers Representative from (i) the funds in the Expense Fund, (ii) the amounts in the Escrow Amount at such |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
31
time as remaining amounts would otherwise be distributable to the Sellers, and (iii) from any Milestone Payments at such time as any such amounts would otherwise be distributable to the Sellers; provided, that while this section allows the Sellers Representative to be paid from the Expense Fund, the Escrow Amount and the Milestone Payments, this does not relieve the Sellers from their obligation to promptly pay such Representative Losses as they are suffered or incurred, nor does it prevent the Sellers Representative from seeking any remedies available to it at law or otherwise. In no event will the Sellers Representative be required to advance its own funds on behalf of the Sellers or otherwise. For the avoidance of doubt and notwithstanding anything in this Agreement to the contrary, the limitations on liability of the Sellers set forth elsewhere in this Agreement are not intended to be applicable to the indemnities provide to the Sellers Representative under this clause 12.13. The Sellers acknowledge and agree that the foregoing indemnities will survive the resignation or removal of the Sellers Representative or the termination of this Agreement. |
13. |
PAYMENTS |
13.1. |
Payments to be made to the Sellers under this Agreement shall be made in US dollars by telegraphic transfer of immediately available funds to such account controlled by the Payments Administrator as may be notified by the Payments Administrator or the Sellers Representative in writing to the Buyer. |
13.2. |
Payments to be made to the Buyer under this Agreement shall be made in US dollars by telegraphic transfer of immediately available funds to such account as may be notified in writing by the Buyer to the Payments Administrator. |
13.3. |
The payment of any sum to the Buyer by or on behalf of any of the Sellers will discharge the obligations of the Sellers to pay the sum in question and the Sellers shall not be concerned to see the application of the monies so paid. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
32
13.4. |
The payment of any sum to the Payments Administrator by or on behalf of the Buyer will discharge the obligations of the Buyer to pay the sum in question and the Buyer shall not be concerned to see the application of the monies so paid. |
14. |
ANNOUNCEMENTS |
14.1. |
Subject to clause 14.2, no party (the disclosing party) may, before or after Completion, make or issue a public announcement or press release concerning the transactions referred to in this Agreement other than the Press Release unless it has first obtained the written consent of the Sellers (prior to Completion, if the disclosing party is the Buyer) or the Sellers Representative (after Completion, if the disclosing party is the Buyer), or of the Buyer (if the disclosing party is a Seller) (in either case, the other party), which consent may not be unreasonably withheld or delayed. |
14.2. |
Clause 14.1 does not apply to a public announcement or press release required by law, by a rule of a listing authority by which a partys shares are listed, a stock exchange on which a partys shares are listed or traded or by a governmental authority or other authority with relevant powers to which either party is subject or submits, whether or not the requirement has the force of law, provided that the public announcement, communication or circular shall so far as is practicable be made after consultation with the other party and after taking into account the reasonable requirements of the other party as to its timing, content and manner of making or despatch. |
15. |
CONFIDENTIALITY |
15.1. |
Subject to clause 15.4, each party shall treat the following information as confidential to the extent obtained as a result of or in connection with entering into this Agreement: |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
33
(a) |
details of the provisions of this Agreement, the Transactional Documents and any other agreement or arrangement entered into in connection with this Agreement; |
(b) |
information relating to the negotiations leading to the execution of this Agreement, the Transactional Documents and any other agreement or arrangement entered into in connection with this Agreement; and |
(c) |
(to the extent obtained as a result of or in connection with entering into this Agreement) information relating to the other party or such partys group undertakings, |
provided that the parties shall always be permitted to confirm that the transaction effected by this Agreement has taken place without providing any further information.
15.2. |
Any party may disclose information otherwise required by clause 15.1 to be treated as confidential: |
(a) |
if and to the extent required by the laws of any relevant jurisdiction, provided that the disclosing party shall, where it is practicable to do so and where permitted under applicable law, notify the other party of such disclosure in writing and take reasonable steps to minimize the extent of any such required disclosure; |
(b) |
if and to the extent requested by any competent regulatory or governmental body, Tax Authority or securities exchange in any relevant jurisdiction wherever situated, whether or not the request has the force of law and including for the avoidance of doubt, any disclosure required by US accounting regulations; |
(c) |
to a Tax Authority in connection with the Tax affairs of the disclosing party; |
(d) |
to its professional advisers, auditors or bankers from time to time provided that such disclosure is reasonably required; |
(e) |
to its shareholders and/or its limited partners as appropriate; |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
34
(f) |
in the case of the Buyer, to members of the Buyers Group and to their professional advisers, auditors or bankers in each case from time to time; |
(g) |
if and to the extent the information is or comes into the public domain through no fault of that part of any of those to whom that party has disclosed information; or |
(h) |
if and to the extent, in the case of a Seller, the Buyer or, in the case of the Buyer, the Sellers Representative, has given prior written consent to the disclosure. |
15.3. |
Each party shall ensure that any person to whom confidential information is disclosed pursuant to clauses 15.2(d) through 15.2(f) is made aware of the obligations of confidentiality contained in this clause and agrees to adhere to them. |
15.4. |
Notwithstanding anything in this Agreement to the contrary, following Completion, the Sellers Representative shall be permitted to: (i) after the public announcement (if any) of the transaction contemplated by this Agreement, publicly announce that it has been engaged to serve as the Sellers Representative in connection with the transaction as long as such announcement does not disclose any of the other terms hereof and (ii) disclose information to the Sellers who have a need to know such information provided that any such information will be subject to the confidentiality provisions of this Agreement including clause 15.1. |
16. |
COSTS |
Except where this Agreement or the relevant document provides otherwise, each party shall pay its own costs relating to the negotiation, preparation, execution and performance by it of this Agreement and of each document referred to in it.
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
35
17. |
GENERAL |
17.1. |
A variation of this Agreement is valid only if it is in writing and signed by or on behalf of each party, provided that after Completion, any variation may be signed by the Sellers Representative on behalf of itself and the Sellers provided the Sellers Representative has the prior written approval of the Sellers Majority. The parties to this Agreement do not require the consent of any person having a right under the Contracts (Rights of Third Parties) Act 1999, as provided in clause 17.7, to rescind or vary this agreement. |
17.2. |
The failure to exercise or delay in exercising a right or remedy provided by this Agreement or by law does not impair or constitute a waiver of the right or remedy or an impairment of or a waiver of other rights or remedies. No single or partial exercise of a right or remedy provided by this Agreement or by law prevents further exercise of the right or remedy or the exercise of another right or remedy. |
17.3. |
The Buyers rights and remedies contained in this Agreement are cumulative and not exclusive of rights or remedies provided by law to the extent not excluded or limited by this Agreement. |
17.4. |
Except to the extent that they have been performed and except where this Agreement provides otherwise, the obligations contained in this Agreement remain in force after Completion. |
17.5. |
Any payment by a Seller, pursuant to a Fundamental Warranty Claim, Special Indemnity Claim or Tax Warranty Claim or a Warrantor, pursuant to a Warrantor Fundamental Warranty Claim or a Business Warranty Claim shall, to the extent possible and without limiting the liability of any Seller or Warrantor (as the case may be) under this Agreement, be treated as a reduction in the purchase price payable by the Buyer for the Shares. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
36
17.6. |
All payments made by a Seller under this Agreement shall be made gross, free of right of counterclaim or set off and without deduction or withholding of any kind other than deductions or withholding required by law. |
17.7. |
Except as provided in clauses 10.7 and 11.7, a person who is not a party to this Agreement has no right, including under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement. |
18. |
ENTIRE AGREEMENT |
18.1. |
The Transactional Documents constitute the entire agreement between the parties. They supersede any previous agreements relating to the subject matter of the Transactional Documents, and set out the complete legal relationship of the parties arising from or connected with that subject matter. |
18.2. |
Nothing in this clause 19 shall have the effect of limiting any liability arising from fraud or wilful non-disclosure. |
19. |
ASSIGNMENT |
19.1. |
Subject to clause 19.2, no right or obligation arising under this Agreement or any other Transactional Document may be assigned, transferred or otherwise disposed of, in whole or in part without the prior written agreement if the assignor is the Buyer, of the Sellers Representative, or if the assignor is a Seller, of the Buyer. |
19.2. |
The Buyer shall be entitled to assign any benefit arising under or out of this Agreement or any other Transactional Document to any Buyers Group Undertaking provided that the Buyer enters into a guarantee in a form reasonably satisfactory to the Sellers Representative and further provided that, if the assignee is to cease to be a Buyers Group Undertaking it shall, before ceasing to be so, assign the benefit (so far as it is assigned) to another Buyers Group Undertaking. |
19.3. |
The Buyer agrees that if it makes an assignment pursuant to this clause 19, the assignment shall not increase the liabilities of any Seller. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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20. |
NOTICES |
20.1. |
A notice or other communication under or in connection with this Agreement (a Notice) shall be: |
(a) |
in writing; |
(b) |
in the English language; and |
(c) |
delivered personally or sent by first class post (and air mail if overseas) or fax or email to the party due to receive the Notice to the address set out in clause 20.3 or to an alternative address, person or fax number or email address specified by that party by not less than five Business Days written notice to the other party received before the Notice was despatched. |
20.2. |
Unless there is evidence that it was received earlier, a Notice is deemed given if: |
(a) |
delivered personally, when left at the address referred to in clause 20.3; |
(b) |
sent by mail, except air mail, two Business Days after posting it; |
(c) |
sent by air mail, six Business Days after posting it; and |
(d) |
sent by email, when the email is sent, provided that a copy of the Notice is sent by another method referred to in this clause 20.2 on the same Business Day as the sending of the email, and provided further that the sender of the email does not receive an automated response from the recipient or a mail server indicating that the recipient is out of office or that the email could not be delivered. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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20.3. |
The address referred to in clause 23.1.3 is: |
Name of Party | Address | Email address or telephone number | For the attention of | |||
Each Seller | In relation to each Seller, the address set out adjacent to that Sellers name in column A of Schedule 1 (The Sellers). | |||||
Sellers Representative |
Shareholder Representative Services LLC 1614 15th Street, Suite 200, Denver, CO 80202, United States |
deals@srsacquiom.com | Managing Director | |||
The Buyer |
201 Gateway Boulevard South San Francisco California United States |
[***] | Nick Galli and Alexander Schuth |
21. |
COUNTERPARTS |
This Agreement may be executed in any number of counterparts, each of which when executed and delivered is an original and all of which together evidence the same agreement.
22. |
GOVERNING LAW |
This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.
23. |
DISPUTE RESOLUTION |
23.1. |
If a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute), it shall be resolved pursuant to this clause 23. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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23.2. |
General |
Any Dispute shall first be referred to the Chief Executive Officer of the Buyer and the Sellers Representative, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by such persons shall be conclusive and binding on the parties to this Agreement. If such persons are not able to agree on the resolution of any such issue within thirty (30) days (or such other period of time as mutually agreed by the Buyer and the Sellers Representative) after such issue was first referred to them, then either the Buyer or the Sellers Representative may, by written notice to the other, elect to initiate an alternative dispute resolution (ADR) proceeding pursuant to the procedures set forth in clause 23.3 for purposes of having the matter settled.
23.3. |
ADR |
Any ADR proceeding under this Agreement (with the exception of that specified in paragraph 11 of Schedule 8) shall take place pursuant to the procedures set forth in clause 15.7.3 of the License Agreement, save that references to Denali are references to the Buyer and references to the Licensor are references to the Sellers (or relevant Seller).
23.4. |
Interim Relief |
Notwithstanding anything herein to the contrary, nothing in this clause 23 shall preclude either party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute following the ADR procedures set forth in clause 23.3, if necessary to protect the interests of such party. This clause shall be specifically enforceable.
23.5. |
RIGHTS OF EACH PARTY/NON-WAIVER |
The rights of each party under this Agreement:
(a) |
may be exercised as often as necessary; |
(b) |
except as otherwise expressly provided in this Agreement, are cumulative and not exclusive of rights and remedies provided by law; and |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
40
(c) |
may be waived only in writing and specifically. |
24. |
PROCESS AGENTS |
The Buyer irrevocably appoints [***] as its process agent to receive on its behalf service of process in any proceedings [***]. Service upon the process agent shall constitute good and valid service on the Buyer whether or not the process is forwarded to or received by the Buyer. If for any reason the process agent ceases to act as process agent, resigns [***], the Buyer irrevocably agrees to appoint a substitute process agent [***] acceptable to the Sellers Representative and to deliver to the Sellers Representative a copy of the substitute process agents acceptance of that appointment within 10 Business Days of the obligation to appoint arising. In the event that the Buyer fails to appoint a substitute process agent, it shall be effective service for the Sellers (or the Sellers Representative) to serve process upon the last known address [***] of the last known process agent for the Buyer notified to the Sellers, notwithstanding that such process agent is no longer found at such address or has ceased to act.
25. |
CONFLICT WAIVER |
Notwithstanding that the Company has been represented by Cooley (UK) LLP (the Firm) in the preparation, negotiation and execution of this Agreement and the transactions contemplated hereby, the Company agrees that after Completion the Firm may represent the Sellers Representative, the Sellers and/or their Affiliates in matters related to this Agreement and the transactions contemplated hereby, including without limitation in respect of any indemnification claims pursuant to this Agreement and the transactions contemplated hereby. The Company hereby acknowledges, on behalf of itself and its Affiliates, that it has had an opportunity to ask for and has obtained information relevant to such representation, including disclosure of the reasonably foreseeable adverse consequences of such representation, and it hereby waives any conflict arising out of such future representation.
IT WITNESS whereof this Agreement has been entered into as a deed and is delivered on the date first aforementioned.
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
41
SCHEDULE 1
The Sellers
(A) |
(B) | (C) | (D) | (E) | (F) | |||||||||||||||
Name and Address of Seller |
No. of Ordinary
Shares |
No. of Deferred
Shares |
Proportion of Initial
Consideration (%) |
Contribution to
Expense Fund (US$) |
Contribution to
Escrow Account (%) |
|||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||||||||||||
[***] |
[***] | [***] | [***] | [***] | [***] |
[***]
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
42
SCHEDULE 2
Information about the Company
Registered Number: | 10214672 | |
Place of Incorporation: | England and Wales | |
Address of Registered Office: |
Eddeva B920 Babraham Research Campus Cambridge CB22 3AT |
|
Type of Company: | Private company limited by shares | |
Total Issued Share Capital: | £90.39625 comprising (i) 8,969,550 ordinary shares; and (ii) 70,075 deferred shares, in each case with an aggregate nominal value of £0.00001 with £0.00001 paid up on each share | |
Directors: |
John Edwards Jean-Francois Formela Deborah Harland Tolga Hassan John Haurum Patrick Krol Florian Ruker Helmut Schuehsler |
|
Secretary: | Tolga Hassan | |
Accounting Reference Date: | 31 December | |
Subsidiaries: | None |
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SCHEDULE 3
Completion Requirements
1. |
Sellers Obligations |
1.1. |
At Completion, each Seller shall deliver the following documents or items to the Buyer or at the Buyers direction: |
1.1.1. |
duly executed transfer(s) in respect of that Sellers Relevant Shares to the Buyer or its nominee(s) and the share certificate(s) for such Relevant Shares; |
1.1.2. |
duly executed powers of attorney or other authorities in the agreed form under which this Agreement, the other Transactional Documents and the transfers referred to in paragraph 1.1.1 of this Schedule 3 have been or are to be executed by such Seller; and |
1.1.3. |
(if the Buyer so requires) an irrevocable power of attorney in the agreed form duly executed by such Seller and any other registered owner of such Sellers Relevant Shares in favour of the Buyer or its nominee(s) generally in respect of the Relevant Shares. |
1.2. |
At Completion the Sellers shall deliver, procure delivery or make available to the Buyer: |
1.2.1. |
each register, minute book and other book required by law to be kept by the Company made up to the Completion Date and each certificate of incorporation and certificate(s) of incorporation on change of name for the Company; |
1.2.2. |
(if the Buyer so requires) resignations in the agreed form from each director and secretary of the Company expressed to take effect from the end of the meeting held pursuant to paragraph 1.3; |
1.2.3. |
the Management Accounts; |
1.2.4. |
a copy of each bank mandate of the Company and copies of statements of each bank account of the Company made up to a date not earlier than two (2) Business Days before the Completion Date; |
1.2.5. |
a counterpart of the Escrow Agreement duly executed by the Sellers Representative; and |
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1.2.6. |
the Disclosure Letter signed on behalf of each Warrantor. |
1.3. |
The Sellers shall ensure that at Completion a meeting of the board of directors of the Company is held at which the directors: |
1.3.1. |
vote in favour of the registration of the Buyer or its nominee(s) as member(s) of the Company in respect of the Shares (subject to the production of properly stamped transfers); and |
1.3.2. |
approve the payment of the Transaction Costs. |
2. |
Buyers Obligations |
2.1. |
At Completion, the Buyer shall deliver to the Sellers: |
2.1.1. |
a counterpart of the Escrow Agreement duly executed by the Buyer; and |
2.1.2. |
a counterpart of the Disclosure Letter signed by the Buyer. |
2.2. |
At Completion, the Buyer shall procure that the Company shall pay the Transaction Costs to the extent not already paid. |
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SCHEDULE 4
Completion Accounts
Part A: Preparation of Completion Accounts
1. |
The Buyer shall procure that Draft Completion Accounts are prepared in accordance with the provisions of this Part A of Schedule 4 and on the basis of the Accounting Policies. |
2. |
The Draft Completion Accounts shall be delivered to the Sellers Representative by the Buyer as soon as is reasonably practicable and, in any event, not later than 90 calendar days after Completion. |
3. |
If the Sellers Representative does not within 30 calendar days of presentation to it of the Draft Completion Accounts give notice to the Buyer that it disagrees with the Draft Completion Accounts or any item therein, stating the reasons for the disagreement in reasonable detail including each disputed item, the amount in dispute and the basis for such dispute (the Sellers Disagreement Notice), the Draft Completion Accounts shall constitute the Completion Accounts and shall be final and binding on the parties for all purposes in accordance with paragraph 12 of this Part A of Schedule 4. |
4. |
If the Sellers Representative gives a Sellers Disagreement Notice under paragraph 3, the Buyer and the Sellers Representative shall attempt in good faith to reach agreement in respect thereof (and, if such agreement is reached, the Draft Completion Accounts as amended by the matters set out in the Sellers Disagreement Notice and agreed by the Buyer and the Sellers Representative in writing shall constitute the Completion Accounts and shall be final and binding on them for all purposes in accordance with paragraph 12 of this Part A of Schedule 4). If they are unable to do so within 30 calendar days of such notification under paragraph 3 of this Part A of Schedule 4, either party may, by notice to the other (an Appointment Notice), require that the Draft Completion Accounts be referred to an independent firm of internationally recognised chartered accountants agreed upon by the Buyer and the Sellers Representative or, failing agreement within five (5) Business Days of service of the Appointment Notice, nominated by the President for the time being of the Institute of Chartered Accountants in England and Wales or in his/her absence a suitable deputy (the Reporting Accountants). |
5. |
The Reporting Accountants shall be engaged jointly by the Buyer and the Sellers (acting through the Sellers Representative) and the charges (including any VAT) of the Reporting Accountants shall be allocated between the Buyer on the one hand and the Sellers (acting through the Sellers Representative) on the other by the Reporting Accountants in proportion |
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to the extent either of such parties did not prevail in the aggregate on the disputed items (as measured by the amounts in dispute). If any amount is payable by the Sellers pursuant to this paragraph 5, such amount shall be paid from the Escrow Account when the Buyer and the Sellers Representative shall within three (3) Business Days following the date of such election or within five (5) Business Days of the Determination Date (whichever is later) jointly instruct the Escrow Agent in writing to make such payment out of amounts standing to the credit of the Escrow Account. |
6. |
Except to the extent that the Buyer and the Sellers Representative agree otherwise, the Reporting Accountants shall determine their own procedure but each party shall use all reasonable endeavours to procure that the Reporting Accountants apply the following rules: |
6.1. |
apart from procedural matters and as otherwise set out in this Agreement, they shall determine only: |
6.1.1. |
whether any of the arguments for an alteration to the Draft Completion Accounts put forward in respect of matters specified in the Sellers Disagreement Notice is correct in whole or in part (unless such matters have been agreed between the Sellers Representative and the Buyer); and |
6.1.2. |
if so, what alterations (if any) should be made to the Draft Completion Accounts; |
6.2. |
they shall apply the Accounting Policies; |
6.3. |
they shall make their determination pursuant to paragraph 6.1 of this Part A of Schedule 4 as soon as is reasonably practicable; |
6.4. |
the procedure of the Reporting Accountants shall: |
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6.4.1. |
give the Buyer and the Sellers Representative a reasonable opportunity to make oral representations and representations in writing to them; |
6.4.2. |
require that each party supplies the other with a copy of any representations in writing at the same time as they are made to the Reporting Accountants; and |
6.4.3. |
permit each party to be present while oral submissions are being made by the other party; |
6.5. |
for the avoidance of doubt, the Reporting Accountants shall not be entitled to determine the scope of their own jurisdiction; and |
6.6. |
the determination of the Reporting Accountants pursuant to paragraph 6.1 of this Part A of Schedule 4 shall be made in writing. |
7. |
The Reporting Accountants shall act as experts and not as arbitrators and their determination of any matter falling within their jurisdiction shall be final and binding on the parties, save in the event of fraud of the Buyer, any of the Sellers or the Reporting Accountants or manifest error of the Reporting Accountants (when the relevant part of their determination shall be void). In particular, without limitation, their determination shall be deemed to be incorporated into the Draft Completion Accounts, which shall then be final and binding on the parties for the purposes of this Schedule 4, save as stated above in the event of fraud or manifest error. |
8. |
The Buyer and the Sellers Representative shall co-operate with the Reporting Accountants and comply with their reasonable requests made in connection with the carrying out of their duties pursuant to their engagement under the terms of this Agreement. |
9. |
Subject to paragraph 10 of this Part A of Schedule 4, nothing in this Schedule 4 shall entitle the Buyer or the Sellers Representative or the Reporting Accountants to have access to any information or document which is protected by legal professional privilege, or which has been prepared by the other party or its accountants or other professional advisers with a view to assessing the merits of any claim or argument. |
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10. |
The Buyer and the Sellers Representative shall not be entitled by reason of paragraph 9 of this Part A of Schedule 4 to refuse to supply such part or parts of documents as contain only the facts on which the relevant claim or argument is based. |
11. |
Each party and the Reporting Accountants shall, and shall procure that its accountants and other advisers shall, keep all information and documents provided to them pursuant to this Part A of Schedule 4 confidential and shall not use them for any purpose, except for disclosure or use in connection with the preparation of the Draft Completion Accounts and the agreement or determination of the Completion Accounts, the proceedings of the Reporting Accountants or any other matter arising out of this Agreement or in defending any claim or argument or alleged claim or argument relating to this Agreement or its subject matter. |
12. |
When the Sellers Representative and the Buyer reach agreement on the Draft Completion Accounts or when the Draft Completion Accounts is finally determined at any stage in accordance with the procedures set out in this Part A of Schedule 4: |
12.1. |
the Draft Completion Accounts as so agreed or determined shall constitute the Completion Accounts for the purposes of this Agreement and shall (in the absence of fraud or manifest error) be final and binding on the parties; and |
12.2. |
the Actual Net Cash shall be the amount set out in line item E in the Completion Accounts. |
13. |
Subject to paragraph 9 of this Part A of Schedule 4 and clause 15 of the Agreement, each Seller shall (in relation to information in its possession or control only) and the Buyer shall procure that the Company shall (in relation to information in their respective possession or control), promptly provide the parties, their respective advisers, the Buyers accountants and the Sellers accountants and, if relevant, the Reporting Accountants with all information (in their respective possession or control) |
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relating to the operations of the Company, as the case may be, including access at all reasonable times to the Company and the employees of the Company (who shall give such explanations as any party may reasonably require in relation to the preparation of the Draft Completion Accounts), books, records, and other relevant information and all cooperation and assistance, as in any such case be reasonably required to enable the production and agreement or determination of the Completion Accounts pursuant to and in accordance with this Part A of Schedule 4; provided however, that the auditors or accountants of the Buyer or the Company shall not be obliged to make any work papers available to any person unless and until such person has signed a customary agreement relating to access to such work papers in form and substance reasonably acceptable to the Buyer and such auditors or accountants. |
14. |
The Sellers (acting through the Sellers Representative) and the Buyer shall each bear their own costs (including legal costs) and expenses (including tax) together with VAT charged thereon, arising out of the preparation and review of the Draft Completion Accounts and the agreement or determination of the Completion Accounts. |
Part B: Completion Accounts
[***] | ||||
[***] | ||||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Part C: Accounting Policies
1. General Accounting Policies
1.1. |
The Completion Accounts shall be determined in accordance with the following: |
(a) |
first, in accordance with the [***]; |
(b) |
secondly, and to the extent not covered by or inconsistent with paragraph 1.1(a) of this Part C of Schedule 4 (which shall prevail in the event of any inconsistency), on a basis consistent with [***]; and |
(c) |
thirdly, and to the extent not covered by or inconsistent with paragraphs 1.1(a) or 1.1(b) of this Part C of Schedule 4 (which shall prevail in the event of any inconsistency), [***]. |
1.2. |
The parties acknowledge that the sole purpose of determining the Actual Net Cash is to determine the adjustments (if any) to be made to the Initial Consideration in accordance with clause 3. |
1.3. |
The provisions of this Part C of Schedule 4 and the line items comprising the Completion Accounts shall be interpreted so as to avoid double counting (whether positive or negative) of any items to be included in the Actual Net Cash. |
Part D: Preparation of Management Accounts
1. ACCOUNTING POLICIES
a. PRESENTATION OF MANAGEMENT ACCOUNTS
CRITICAL ACCOUNTING JUDGMENTS AND KEY SOURCES OF ESTIMATION UNCERTAINTY
In the application of the Companys accounting policies, management make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period of the revision and future periods if the revision affects both current and future periods.
b. |
OVERALL CONSIDERATIONS |
The principal accounting policies adopted in the preparation of the management accounts are set out below.
i. |
BASIS OF PREPARATION OF MANAGEMENT ACCOUNTS |
These management accounts have been prepared in accordance with EU endorsed International Financial Reporting Standards (IFRS) and interpretations issued by the IFRS Interpretations Committee (IFRS IC) and the Companies Act 2006 applicable to companies reporting under IFRS. The management accounts have been prepared under the historical cost convention.
ii. |
GOING CONCERN |
Management prepare management accounts on a going concern basis unless they intend to liquidate the business or to cease trading, or have no realistic alternative but to do so. In deciding whether the going concern basis is appropriate, the directors examine existing budgets and forecasts, assess borrowing requirements, and review other information as needed.
iii. |
NEW AND AMENDED STANDARDS ADOPTED BY THE COMPANY |
In any period, new or amended standards and interpretations are considered for adoption. Other standards, amendments and interpretations which are effective for the period are considered where they material to the Company.
c. |
RECEIVABLES |
Receivables are recognised initially at fair value less provision for impairment. The Company provides an allowance for uncollectible accounts based on prior experience and managements assessment of the collectability of existing specific accounts.
d. |
CASH AND CASH EQUIVALENTS |
Cash and cash equivalents comprises cash on hand and demand deposits, and other short-term and highly liquid investments with original maturities of three months or less that are readily convertible to a known amount of cash and are subject to an insignificant risk of changes in value.
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e. |
EQUITY AND RESERVES |
Ordinary and preferred shares are classified as equity. Issued capital represents the nominal value of shares that have been issued. Retained earnings includes all current period retained profits and accumulated losses.
f. |
TRADE PAYABLES |
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Trade and other payables are stated at cost, which approximates fair value due to the short term nature of these liabilities. Trade payables are classified as current liabilities if payment is due within one period or less. If not, they are presented as non-current liabilities.
g. |
REVENUE RECOGNITION |
Revenue is measured at the fair value of the consideration received or receivable and is stated net of value added taxes. Revenue is recognised when it is probable that future economic benefits will flow to the Company and those benefits can be measured reliably. Revenue on the sale of an asset (e.g. the outright sale or assignment of a licence) is only recognised when, inter alia, the significant risks and rewards of ownership have been transferred to the buyer and the Company does not retain either control of the goods, or continuing involvement, to the degree associated with ownership.
Where, as part of a licence agreement, services are performed by an indeterminate number of acts over a specified period of time, revenue for such services is recognised on a straight-line basis over the specified period unless there is evidence that some other method represents better the stage of completion.
h. |
SHARE BASED PAYMENTS |
A share option compensation charge is not recognised in the monthly management accounts.
i. |
TAXATION AND DEFERRED TAX |
A tax credit or charge is not reflected in the monthly management accounts. Deferred tax is not reflected in the monthly management accounts.
j. |
FINANCIAL INSTRUMENTS |
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i. |
FINANCIAL ASSETS |
All financial assets relate to trade and other receivables, which are stated at their recoverable amount, which approximates the fair value due to the short term nature of these assets.
ii. RISK MANAGEMENT POLICY
The Company undertakes transactions denominated in foreign currencies and as such is exposed to currency risk due to fluctuations in foreign exchange rates. The Company does not use derivative instruments to reduce exposure to foreign exchange risk.
iii. |
FINANCIAL LIABILITIES |
Trade and other payables are stated at cost. This approximates fair value due to the short term nature of these liabilities.
k. |
FOREIGN CURRENCY TRANSLATION |
Foreign currency transactions are translated at the rates of exchange in effect at the dates of the transaction. Resulting foreign currency denominated monetary assets and liabilities are translated at the rates of exchange in effect at the balance sheet date. Gains and losses on foreign exchange are recognised in the income statement.
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SCHEDULE 5
Contingent Consideration
Part A: Contingent Consideration
1. |
Definitions |
In this Schedule 5, and where applicable, the remainder of this Agreement, the following definitions shall apply:
Accepted Fcab Target has the meaning given to it in the License Agreement, with respect to events and circumstances before Completion and has the meaning given to it in the Gamma IP License with respect to events and circumstances after Completion;
Commercialisation has the meaning given to it in the License Agreement;
Commercially Reasonable Efforts has the meaning given to it in the License Agreement;
Conforming mAb2 means [***];
Contingent Consideration means any of the Milestone Payments;
Default Notice has the meaning given to it in paragraph 2.2 of this Part A of Schedule 5;
Denali Fcab has the meaning given to it in the License Agreement;
EU Regulatory Milestone means [***];
European Union or E.U. has the meaning given to it in the License Agreement and shall be deemed to include [***];
Fcab Delivery means, with respect to an Accepted Fcab Target, that an Fcab that specifically binds to such Accepted Fcab Target has achieved Fcab Delivery (as defined therein) under Section 4.3 or Section 9.11.1 of the License Agreement or Section 4.1.2 of the Gamma Services Agreement during the applicable Fcab Disclosure Period (as defined therein);
First Commercial Sale has the meaning given to it in the License Agreement, except that all references to Licensed Products in such definition will be read as references to mAb2 Products;
Fcab has the meaning given to it in the License Agreement;
Fcab Disclosure Period has the meaning given to it in Section 1.3.3 of that certain letter agreement between the Company, F-Star, F-Star GmbH and Buyer dated and entered into on or about May , 2018;
GMP has the meaning given to it in the License Agreement;
Initial Milestone has the meaning given to it in the table in Part B of this Schedule 5;
Initial Payment True Up Event means that [***];
Joint Fcab has the meaning given to it in the License Agreement;
Licensor Fcab has the meaning given to it in the License Agreement;
mAb2 Product means [***];
Major EU Market means [***].
Milestone Event means the relevant event as set out in column 1 of Part B of this Schedule 5, which shall trigger the relevant Milestone Payment. In addition:
a) |
where [***], it shall be considered a Milestone Event in respect of which the Buyer will pay to the Sellers a one-time payment (which shall constitute a Milestone Payment) of [***]; |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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b) |
[intentionally left blank]; |
c) |
[intentionally left blank]; and |
d) |
[***]; |
Milestone Payment means, with respect to a Milestone Event:
a) |
if [***], a payment equal to [***] of the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event; and |
b) |
if [***], a payment equal to [***] of the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event; |
In no event will more than one Milestone Payment be made for a given Milestone Event, regardless of how many mAb2 Products achieve such Milestone Event, except that [***], then a second Milestone Payment shall become due with respect to such Milestone Event, in an amount equal to [***] of the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event. For clarity, under no circumstances will the total Milestone Payments that the Buyer becomes obligated to make in respect to a given Milestone Event exceed the Maximum Milestone Payment amount set out column 2 of Part B of this Schedule 5 in the row corresponding to the applicable Milestone Event;
Net Sales means, with respect to a mAb2 Product for any period, the total amount billed or invoices on sales of such mAb2 Product during such period by the Buyer, its Affiliates or sublicensees, calculated in accordance with the definition of Net Sales used in the License Agreement, and reading all references to Licensed Products in such definition as references to mAb2 Products;
Non-conforming mAb2 means a mAb2 Product that is not a Conforming mAb2;
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Payment Date means the date which is 90 calendar days after any date on which a Milestone Payment is triggered;
Regulatory Approval has the meaning given to it in the License Agreement;
Relevant Period means the period from Completion until [***];
Remaining Amount means the aggregate Contingent Consideration payable pursuant to [***] minus the aggregate Contingent Consideration actually paid by the Buyer pursuant to [***] prior to the date of delivery of a Default Notice;
Risk-Adjusted Remaining Amount means [***];
Total Contingent Consideration means the aggregate of the Milestone Payments; and
US Regulatory Milestone means [***].
2. |
Conduct of business during Relevant Period |
Commercially Reasonable Efforts
2.1. |
The Buyer shall during the Relevant Period use Commercially Reasonable Efforts to achieve both of the EU Regulatory Milestone and the US Regulatory Milestone. The Sellers acknowledge and agree that, in addition to the foregoing: |
(a) |
the Buyer shall be deemed to have satisfied its obligations under this paragraph 2.1 of Schedule 5 so long as the Buyer is using Commercially Reasonable Efforts to advance [***] toward achievement of the [***]; |
(b) |
the Buyer shall have the right to satisfy its diligence obligations under this paragraph 2.1 of Schedule 5 through its Affiliates or Sublicensees; and |
(c) |
nothing in this paragraph 2.1 of Schedule 5 is intended, or shall be construed, to require the Buyer to Develop: |
(i) |
[***]; or |
(ii) |
[***] |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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2.2. |
If at any time the Sellers have a reasonable basis to believe that the Buyer is in material breach of its obligations under paragraph 2.1 of Schedule 5 and such material breach has continued for a period of at least [***] (a Continuing Material Breach), then the Sellers shall cause the Sellers Representative to deliver written notice (the Default Notice) of such Continuing Material Breach to the Buyer and, if the Buyer fails to remedy such Continuing Material Breach within 60 days of receipt of the Default Notice, then the provisions of paragraph 2.3 shall apply. |
2.3. |
If the Buyer is in Continuing Material Breach of its obligations under paragraph 2.1 and following receipt of a Default Notice fails to remedy such Continuing Material Breach within the time period set out in paragraph 2.2, then the Sellers Representative may, by written notice to the Buyer, elect to initiate an ADR proceeding pursuant to the procedures set forth in clause 23.3, and the arbitrators for such ADR proceeding shall be instructed and required to conduct a proceeding for the sole purposes of [***]. In the event [***] the Buyer is in Continuing Material Breach of its obligations under paragraph 2.1, the Buyer shall pay to the Sellers [***] the Risk-Adjusted Remaining Amount. |
2.4. |
Any amount to be paid by the Buyer pursuant to paragraph 2.3: |
(a) |
to the Cash Sellers, shall be paid by transfer of the relevant funds for same day value to the Payments Administrator, |
(b) |
to the Loan Note Sellers, shall be paid by the issue by the Buyer of Contingent Consideration Loan Notes to each of the Loan Note Sellers equal, in principal amount, to the relevant amount due to each of them pursuant to paragraph 2.3, |
in each case shall be made within 30 Business Days of the expiry of the time period set out in paragraph 2.2 without set off, deduction or withholding (except as required by law or by this Agreement).
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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2.5. |
The Sellers agree between themselves that any payments to the Payments Administrator pursuant to paragraph 2.4 shall be apportioned, and the principal amount of any Contingent Consideration Loan Notes issued pursuant to paragraph 2.4 shall be calculated, by reference to the Sellers respective Proportion of Initial Consideration. The Buyer shall not be responsible for how any such payment to the Payments Administrator is allocated or applied by the Payments Administrator. |
2.6. |
A payment or issue of Contingent Consideration Loan Notes by the Buyer pursuant to paragraph 2.3 shall not discharge the Buyer of its obligation to pay any further Contingent Consideration (if any) above the amounts paid to the Sellers in accordance with paragraph 2.3 upon achievement of the relevant Milestone Events. |
2.7. |
The parties acknowledge that: |
(a) |
any provision in this Agreement that imposes a detriment on a party in breach, in particular as set out in paragraph 2.3 of this Part A of Schedule 5, represents a genuine pre-estimate of the loss expected to be suffered by the party not in breach, and: |
(i) |
protects the legitimate interests of the other parties in the enforcement of the obligation breached; and |
(ii) |
is not out of all proportion to those legitimate interests; and |
(b) |
they are of comparable bargaining power and each of them has been properly advised in relation to this Agreement. |
Record Keeping and Reporting
2.8. |
The Buyer agrees that during the period whilst further Contingent Consideration is payable in accordance with this Schedule 5 it shall, and shall procure that each other Buyers Group Undertaking shall: |
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(a) |
prepare and maintain reasonably complete and accurate records regarding any Commercialisation or Development efforts which relate to any mAb2 Product and all other data necessary for the calculation of the Contingent Consideration; |
(b) |
once per calendar year, on 31 January, and subject to reasonable procedures and agreements to preserve confidentiality, provide the Sellers Representative with a written report on material developments with respect to the Development and Commercialisation of any mAb2 Product, together with such reasonable additional information regarding any such activities or events as the Sellers Representative may reasonably request from time to time (subject to any applicable third party confidentiality restrictions) which shall include copies of relevant documents as requested by the Sellers Representative; and |
(c) |
once per calendar year during the Relevant Period, within 30 days of the Sellers Representatives written request, meet in person or by telephone with the Sellers Representative. At such meetings, the Buyer shall cause senior officers from the research, clinical development, and business operations of the Buyer and/or the Buyers Group Undertakings to attend, to present and to answer questions. Each of the Buyer and the Sellers Representative (on behalf of the Sellers) shall bear its own costs and expenses regarding such meetings. |
2.9. |
Upon receipt of a request from the Sellers Representative, the Buyer shall, and shall ensure each of Buyers Group Undertakings shall, permit an independent auditor designated by the Sellers Representative to inspect and audit the records and books of account maintained by it pursuant to paragraph 2.8 in order to confirm the accuracy and completeness of such records and books of account and the calculation of the Contingent Consideration. Any such audit shall (i) be for a reasonable duration during office hours on a Business Day; (ii) be upon notice of at least 30 days; and (iii) not be requested more than once during each financial year of the period during which any Contingent Consideration remains payable. The Sellers Representative (on behalf of the Sellers) shall pay the costs of each audit unless the audit reveals a variance of more than [***] between the amounts paid and the amounts due, |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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in which case the Buyer shall bear the cost of the audit, provided, however, that in the event the audit pertains to achievement of a Milestone Event relating to the Buyers Net Sales, the Sellers Representative (on behalf of the Sellers) shall pay the costs of each audit unless the audit reveals a variance of more than [***] between the Net Sales reported by Buyer and the Net Sales determined by the audit. If the audit reveals an underpayment by the Buyer, the Buyer shall transfer the amount by which it had underpaid by transfer of funds for same day value to the Payments Administrator for further distribution to the Sellers within 10 Business Days after the date on which such audit is completed. |
Part B: Milestone Payment Amounts
Column 1: Milestone Event |
Column 2: Maximum
Milestone Payment (US$) |
|||
[***] |
[***] | |||
[***] |
[***] | |||
[***] |
[***] | |||
[***] |
[***] | |||
[***] |
[***] | |||
[***] |
[***] | |||
[***] |
[***] | |||
TOTAL = |
[***] |
* |
The maximum Milestone Payment for this Milestone Event shall be increased by [***]. |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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SCHEDULE 6
[***]
Part A: [***]
1. |
CAPACITY AND AUTHORITY |
1.1. |
The Seller has the right, power and authority to execute, deliver and perform its obligations under this Agreement and any other Transactional Document to be executed by the Seller and, where the Seller is not an individual, all such obligations of the Seller have been duly and validly approved and authorized by all necessary action on the part of such Seller, and no other action on the part of such Seller is required in connection therewith. |
1.2. |
If such Seller is not an individual, it has been duly incorporated and is validly existing and in good standing under the laws of the jurisdiction in which it is incorporated or constituted (to the extent that such concepts are recognised in such jurisdiction). |
1.3. |
The Sellers obligations under this Agreement and any other Transactional Document to be executed by the Seller are, or when the relevant document is executed will be, enforceable in accordance with their terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors rights generally and general equitable principles |
1.4. |
The execution and delivery of, and the performance by the Seller of its obligations under, this Agreement and any of the Transactional Documents will not: |
(a) |
if relevant, result in a breach of any provision of its articles of association or by-laws; |
(b) |
result in a breach of, or constitute a default under, any instrument to which the Seller is a party or by which the Seller is bound where such breach may prejudice the transactions contemplated by this Agreement or any of the Transaction Documents; or |
(c) |
result in a breach of any order, judgment or decree of any court or Authority to which the Seller is a party or by which the Seller is bound or submits where such breach may prejudice the transactions contemplated by this Agreement or any of the Transaction Documents. |
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2. |
SHARES |
2.1. |
The Sellers Relevant Shares constitute the whole of the Sellers interest in the allotted and issued share capital of the Company and the Seller does not exercise voting power over any other outstanding shares or other equity interests of the Company. |
2.2. |
The Seller is entitled to sell and transfer or procure the transfer of the full legal and beneficial ownership of its Relevant Shares to the Buyer on the terms set out in this Agreement. |
2.3. |
The Shares registered in the name of the Seller and set out opposite his name at columns B and C (as applicable) of Schedule 1 have been properly allotted and issued and are fully paid and such Shares will be sold free of all Encumbrances and there is no agreement, arrangement or obligation to give or create any such Encumbrance. No person has claimed to be entitled to an Encumbrance in relation to any such Shares. |
Part B: [***]
1. |
SHARES |
1.1. |
At Completion, the Shares are registered in the name of the Sellers and set out opposite their names at columns B and C (as applicable) of Schedule 1 and constitute the entire issued share capital of the Company, have been properly allotted and issued and are fully paid or credited as fully paid. |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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1.2. |
Other than this Agreement, the Transaction Documents, the Shareholders Agreement or as referred to or contemplated by this Agreement, there is no agreement, arrangement or obligation requiring the creation, allotment, issue, transfer, redemption or repayment of, or the grant to a person by the Company of the right (conditional or not) to require the allotment, issue, transfer, redemption or repayment of, a share in the capital of the Company (including an option or right of pre emption or conversion). |
1.3. |
So far as the Warrantors are aware, no person has claimed to be entitled to an Encumbrance in relation to any Shares. |
1.4. |
Save for this Agreement, the Transaction Documents, the Companys articles of association and the Shareholders Agreement, there are no contracts relating to voting, purchase, sale or transfer of any Shares (i) between or among the Company and any Shareholder, and (ii) so far as the Warrantors are aware, between or among any of the Shareholders. |
2. |
THE GROUP |
2.1. |
The Company does not have, and has not at any time had, any subsidiary undertakings. |
2.2. |
Other than as contemplated by this Agreement, the Company has no interest in, and has not agreed to acquire an interest in or merge or consolidate with, a corporate body or any other person. |
2.3. |
The information contained in Schedule 1 (The Sellers) and Schedule 2 (Information about the Company) is true and accurate. |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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SCHEDULE 7
[***]
1. |
ORGANIZATION |
1.1 |
The Company is a company duly incorporated and validly existing under the laws of England and Wales and has the right, power and authority to execute, deliver and perform its obligations under this Agreement and any other Transactional Document to be executed by it. |
1.2 |
The Companys obligations under this Agreement and any other Transactional Documents to be executed by the Company are, or when the relevant document is executed will be, enforceable in accordance with their terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors rights generally and general equitable principles. |
2. |
ACCOUNTS |
2.1 |
General |
2.1.1 |
The Accounts have been prepared and audited on a proper and consistent basis in accordance with the law and applicable standards, principles and practices generally accepted in the United Kingdom. |
2.1.2 |
The Accounts show a true and fair view of the state of affairs of the Company as at the Last Accounting Date and of the profit or loss of the Company for the financial year ended on the Last Accounting Date. |
2.1.3 |
Save as disclosed in the Accounts, the Accounts have been prepared using the same accounting policies as those adopted and applied in preparing the accounts for the previous two years. |
2.1.4 |
The Company does not have any liabilities of any nature other than (i) those set forth or adequately provided for in the Accounts, (ii) those incurred in the conduct of the Companys business since the Last Accounting Date in the ordinary course, and which, individually or in the aggregate, are not material in nature or amount and do not result from any breach by the Company of any contract, warranty, infringement, tort or violation of law to which it is subject, and (iii) those incurred by the Company in connection with the execution of this Agreement. Except for liabilities reflected in the Accounts, the Company has no off balance sheet liability of any nature to, or any material financial interest in, any third party or entities, the purpose or effect of which is to defer, postpone, reduce or otherwise avoid or adjust the recording of expenses |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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incurred by the Company. Without limiting the generality of the foregoing, the Company has never guaranteed any debt or other obligation of any other person. |
2.2 |
Provision for Tax |
The Accounts include provision or reserve (as appropriate) in accordance with the relevant accounting standards for Tax liable to be assessed on the Company or for which the Company is accountable in respect of profits earned, accrued or received on or before the Last Accounting Date, and in respect of any event occurring on or before the Last Accounting Date.
2.3 |
Accounting records |
The Companys accounting records are up-to-date in all material respects, are in its possession or under its control and are properly completed in accordance with the law and applicable standards, principles and practices generally accepted in the United Kingdom.
3. |
CHANGES SINCE THE LAST ACCOUNTING DATE |
3.1 |
Since the Last Accounting Date: |
3.1.1 |
the Companys business has in all material respects been operated in the usual way so as to maintain it as a going concern; |
3.1.2 |
there has been no material adverse change in the financial or trading position of the Company or the properties, assets (including intangible assets), liabilities, business, prospects, capitalization, employees, operations or results of operations of the Company or any change that would reasonably be expected to materially impede or delay the Companys ability to consummate the transactions contemplated by this Agreement, other than any event, circumstance or change resulting from changes in stock markets, interest rates, exchange rates, commodity prices or other general economic conditions or changes in conditions affecting the industry generally in which the Company operates; |
3.1.3 |
the Company has not made or entered into any contract or letter of intent with respect to, or otherwise effected, any acquisition, sale, license, disposition or transfer of any asset that is material to the business of the Company, including without limitation, Intellectual Property other than IP Licenses Out; |
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3.1.4 |
there has not occurred any change in accounting methods or practices (including any change in depreciation or amortization policies or rates or revenue recognition policies or establishment of reserves) by the Company or any revaluation by the Company of any of its assets; |
3.1.5 |
there has not occurred any declaration, setting aside, or payment of a dividend or other distribution with respect to any securities of the Company, or any redemption, purchase or other acquisition by the Company of any of its securities, or any change in any rights, preferences, privileges or restrictions of any of its outstanding securities; |
3.1.6 |
the Company has not entered into, amended, renewed or terminated any Material Contract (as hereinafter defined), and there has not occurred any material default or breach under any Material Contract to which the Company is a party or by which it is, or any of its assets and properties are, bound; |
3.1.7 |
the Company has not incurred, created or assumed any Encumbrance on any of its assets or properties, any material indebtedness, or any liability as guarantor or surety with respect to the obligations of any other person; and |
3.1.8 |
the Company has not paid or discharged any Encumbrance or liability which was not shown on the Accounts or incurred in the ordinary course of business consistent with past practice since the Last Accounting Date. |
4. |
TAX |
4.1 |
The Company has, within the last three years, where legally obliged to do so: |
4.1.1 |
duly and punctually paid all Tax which it has become liable to pay, whether or not shown or required to be shown on any Tax return; |
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4.1.2 |
duly deducted, withheld or collected for payment (as appropriate) all Tax due to have been deducted, withheld or collected for payment and has accounted for or paid all such Tax to the relevant Tax Authority (to the extent due); and |
4.1.3 |
not been liable to pay any material interest, penalty or surcharge in respect of any unpaid Tax. |
4.2 |
All returns, computations, information, accounts and notices which are or have been required by law to be made or given by the Company within the last three years for any Tax purposes have been made or given in the required form and have been properly submitted by the Company and are complete and accurate in all material respects. |
4.3 |
The Company has, in the last three years, in all material respects, complied at all times with all statutory requirements, regulations, notices, orders, directions and conditions relating to all relevant Taxes, including the terms of any agreement made with HMRC or any other relevant Tax Authority. |
4.4 |
The Company is not, nor has it at any time within the last three years, been involved in any dispute with or non-routine investigation, audit or discovery by any Tax Authority and, so far as the Warrantors are aware, no such dispute, investigation, audit or discovery is planned. |
4.5 |
There are no liens or encumbrances against any of the Companys assets, arising in connection with a failure to pay any Tax. |
4.6 |
In the last three years, each related party transaction involving the Company is and has been at arms-length in all material respects and determined in compliance in all material respects with applicable transfer pricing rules and regulations. |
4.7 |
The Company does not have any outstanding waivers or extension of the statute of limitations for assessment of any Tax. |
4.8 |
The Company is not a party to, or bound by, any Tax indemnity agreement, Tax sharing agreement or Tax allocation agreement with respect to Taxes (other than any agreement entered into in the ordinary course of business and not primarily related |
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to Taxes) and other than this Agreement, the Spin-Out License, and the License Agreement and any other agreement contemplated by any such agreements. The Company is not liable for Taxes of any other Person (i) under any applicable Law, (ii) as a transferee of any assets or successor to any liabilities, or (iii) by Contract, indemnity or otherwise, including by reason of the transactions contemplated by the Gamma IP License. |
4.9 |
In the last three years, no written claim has been made by any Tax Authority in a jurisdiction where the Company does not file Tax Returns that the Company is or may be subject to Taxation by that jurisdiction. |
4.10 |
The Company will not, after the Completion Date, be liable under any applicable Law, by Contract, indemnity or otherwise as a transferee of any assets or successor to any liabilities, for any Taxes of F-star, F-star GmbH, or any of their Affiliates as a result of (i) the Companys entry into, and transactions contemplated by, the Gamma IP License, the License Agreement and the Services Agreement and/or (ii) the transactions contemplated by the Option Agreement and this Agreement other than VAT as provided for in any agreement. |
5. |
ASSETS |
5.1 |
Title and condition |
5.1.1 |
Each asset included in the Accounts or acquired by the Company since the Last Accounting Date is: |
(a) |
legally and beneficially owned solely by the Company; |
(b) |
where capable of possession, in the possession or under the control of the Company. |
5.1.2 |
Company owns or has the right to use each asset used in and necessary for the effective operation of its business. |
6. |
INTELLECTUAL PROPERTY |
The Company owns, or has rights to use, all Intellectual Property materially necessary for the Company to operate its business.
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6.1 |
Registered Owned IP |
6.1.1 |
The Disclosure Letter sets out details of all material registered Intellectual Property owned by the Company (Registered Owned IP). The Company solely owns the Registered Owned IP. |
6.1.2 |
To the best of the knowledge, information and belief of the Warrantors, (i) there are no issued patents or registered trademarks within the Registered Owned IP that are invalid or unenforceable and (ii) there are no patent applications included within the Registered Owned IP that have not been duly filed and diligently prosecuted. |
6.1.3 |
The Company has received an assignment of rights from each inventor listed in the patents and patent applications included in the Disclosure Letter save in the case of those inventors which are employees of the Company and whose inventions vest in the Company by virtue of their employment relationship. The Company is the sole legal and beneficial owner of each of the patents and patent applications. |
6.1.4 |
All issuance, renewal and maintenance fees due up to and including the date of this Agreement in respect of each of the Registered Owned IP have been paid in full and on time. |
6.2 |
No infringement by Company of third party Intellectual Property |
6.2.1 |
To the best of the knowledge, information and belief of the Warrantors, the activities of the Company, and the practice of the inventions claimed under the Registered Owned IP, do not nor have they in the year prior to the date of this Agreement infringed, misappropriated, misused, violated or otherwise made use without authorisation of any third party Intellectual Property nor has any person threatened to the Company in writing to issue such a notice. |
6.2.2 |
To the best of the knowledge, information and belief of the Warrantors, the Company has not issued any opposition, invalidation, revocation or cancellation proceeding or any other proceeding or counterclaim (including any litigation, arbitration or proceeding pursuant to any other dispute resolution mechanism) concerning the validity, enforceability or title to any Intellectual Property of any third party. |
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6.3 |
IP Licenses In and IP Licenses Out |
6.3.1 |
Copies of all material licenses of Intellectual Property granted by the Company (IP Licenses Out) and granted to the Company (IP Licenses In) are included in the Disclosure Bundle. |
6.3.2 |
To the best of the knowledge, information and belief of the Warrantors, no IP License In or IP License Out is currently being, or has at any time been, breached in a material way by the Company or to the best of the Warrantors knowledge, information and belief, by any other party thereto. So far as the Warrantors are aware, the rights granted under the IP Licenses In and IP Licenses Out will not be adversely affected by the transactions contemplated by this Agreement. |
6.3.3 |
To the best of the knowledge, information and belief of the Warrantors, all fees, royalties or other amounts due to be paid by or to the Company in respect of any IP License In or IP License Out have been paid in a timely manner and no such payments have been outstanding for more than 60 days. |
6.4 |
Company Confidential Information |
6.4.1 |
To the best of the knowledge, information and belief of the Warrantors, all Company Confidential Information held by the Company is accurately and properly documented to enable the Buyer to acquire and retain its full benefit and is subject to appropriate storage and security measures to preserve the confidentiality and secrecy of such Company Confidential Information. |
6.4.2 |
To the best of the knowledge, information and belief of the Warrantors, the Company has not disclosed any Company Confidential Information to any person other than (i) its employees and advisors who are bound by obligations of confidence (howsoever arising); (ii) in circumstances where such disclosures have been made in the ordinary course of business; and (iii) pursuant to the IP Licenses Out and the IP Licenses In. |
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7. |
INSURANCE |
7.1 |
Policies |
The Disclosure Letter sets out a list of insurance policies maintained by or on behalf of the Company (together the Policies);
7.2 |
Status of the Policies |
Each of the Policies is valid and enforceable and the Warrantors are not aware of any circumstances that would render any of them void or voidable.
7.3 |
Premiums |
All premiums which are due under the Policies have been paid.
8. |
MATERIAL CONTRACTS |
8.1 |
Validity of Material Contract |
8.1.1 |
Save for the Transaction Documents. the Company is not a party to or bound by any of the following contracts (each a Material Contract): |
(a) |
any contract limiting the freedom of the Company to engage or participate, or compete with any other person, in any line of business, market or geographic area, or to make use of any Intellectual Property, or any contract granting exclusive rights, rights of refusal, rights of first negotiation or similar rights and/or terms to any person, or any contract otherwise limiting the right of the Company to sell, distribute or manufacture any products or services or to purchase or otherwise obtain any products or services; |
(b) |
any licenses, sublicenses and other contracts pursuant to which any person is granted any rights to Intellectual Property of the Company or pursuant to which the Company has agreed to any restriction on the right of the Company to use or enforce any Intellectual Property owned by the Company or pursuant to which the Company agrees to encumber, transfer or sell rights in or with respect to any Intellectual Property owned by the Company; or |
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(c) |
any other contract or obligation that individually had or has a value or payment obligation in excess of US$50,000 over the life of the contract or is otherwise material to the Company or its businesses, operations, financial condition, properties or assets. |
8.1.2 |
Each of the Material Contracts is in full force and effect, subject only to the effect, if any, of applicable bankruptcy and other similar laws affecting the rights of creditors generally and rules of law governing specific performance, injunctive relief and other equitable remedies. |
8.1.3 |
No party to a Material Contract has given notice of its intention to terminate to the Company, or has sought to repudiate or disclaim, the Material Contract. |
8.1.4 |
Neither the Company nor, so far as the Warrantors are aware, any party with whom the Company has entered into a Material Contract is in material breach of the Material Contract. |
8.1.5 |
So far as the Warrantors are aware, no circumstances exist which would give rise to any breach of any Material Contract or to any such Material Contract being terminated or varied without the Companys consent (other than termination without cause upon notice in accordance with the terms of the agreement). |
9. |
EFFECT OF SALE |
Neither the execution nor the performance of this Agreement or any document to be executed at or before the Completion Date will result in the Company losing the benefit of any material asset, grant, subsidy, right or privilege which it enjoys at the date of this Agreement.
10. |
LIABILITIES |
10.1 |
Indebtedness |
The Company does not have outstanding and has not agreed to create or incur loan capital, borrowings, indebtedness in the nature of borrowings other than the trade debt incurred in the ordinary and usual course of trading.
10.2 |
Guarantees and indemnities |
The Company is not a party to and is not liable under a guarantee, indemnity or other agreement to secure or incur a financial or other obligation with respect to another persons obligation.
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10.3 |
Grants |
10.3.1 |
The Company is not liable to repay an investment or other grant or subsidy made to it by a body (including the Department for Business, Innovation and Skills or its predecessor). |
10.3.2 |
No fact or circumstance (including the execution and performance of this Agreement) exists which might entitle a body to require repayment of, or refuse an application by the Company for, the whole or part of a grant or subsidy. |
11. |
RESTRICTIONS ON BUSINESS ACTIVITIES |
Other than the Transaction Documents, there is no contract, judgment, injunction, order or decree binding upon the Company as of the date of this Agreement which has or would reasonably be expected to have, whether before or after Completion, the effect of prohibiting, restricting or impairing any current or presently proposed business practice of the Company, any acquisition of property by the Company or the conduct or operation of the Companys business or limiting the freedom of the Company to engage in any line of business, to sell, license or otherwise distribute services or products in any market or geographic area, or to compete with any person.
12. |
SERVICE PROVIDERS |
12.1 |
The Company has never employed or engaged any employees, consultants, advisory board members, or independent contractors. The Company has never maintained or offered any: |
12.1.1 |
employee benefit plans; |
12.1.2 |
loan to any independent contractor or consultant; |
12.1.3 |
stock option, stock purchase, phantom stock, stock appreciation right, supplemental retirement, severance, sabbatical, medical, dental, vision care, disability, employee relocation, cafeteria benefit, dependent care, life insurance or accident insurance plans, programs or arrangements; |
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12.1.4 |
bonus, pension, profit sharing, savings, severance, retirement, deferred compensation or incentive plans, programs or arrangements; |
12.1.5 |
other fringe or employee benefit plans, programs or arrangements; or |
12.1.6 |
employment or executive compensation or severance agreements, written or otherwise. |
12.2 |
None of the execution and delivery of this Agreement, the Completion or any other transaction contemplated hereby or any termination of employment or service or any other event in connection therewith or subsequent thereto will, individually or together or with the occurrence of some other event: |
12.2.1 |
result in any payment (including severance, unemployment compensation, golden parachute, bonus or otherwise) becoming due to any person; |
12.2.2 |
increase or otherwise enhance any benefits otherwise payable by the Company; |
12.2.3 |
result in the acceleration of the time of payment or vesting of any such benefits; |
12.2.4 |
obligate the payment of compensation to any person; or |
12.2.5 |
result in the forgiveness in whole or in part of any outstanding loans made by the Company to any person. |
13. |
INTERESTED PARTY TRANSACTIONS |
None of the officers and directors of the Company and, as far as the Warrantors are aware, none of the employees of the Company or Shareholders, nor, so far as the Warrantors are aware, any immediate family member of an officer, director, employee or Shareholder, has any direct or indirect ownership, participation, or other interest in, or is an officer, director, employee of or consultant or contractor for any firm, partnership, entity or corporation that competes with, or does business with, or has any contractual arrangement with, the Company (except with respect to (i) F-star or F-star GmbH or (ii) any interest in less than
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five per cent (5%) of the issued share capital of any Company whose shares are publicly traded). None of said officers, directors or Shareholders or, so far as the Warrantors are aware, any employees or member of their immediate families of the foregoing, is a party to or otherwise directly interested in, any contract to which the Company is a party or by which the Company or any of its assets or properties may be bound or affected in a material manner. As far as the Warrantors are aware, none of said officers, directors, employees or Shareholders has any material interest in any property, real or personal, tangible or intangible (including any Intellectual Property) that is directly related to the business of the Company.
14. |
COMPLIANCE WITH OPTION AGREEMENT |
At all times since the Effective Date (as defined in the Option Agreement) the Company has complied in all material respects with its covenants set forth in the Option Agreement.
15. |
INSOLVENCY, WINDING UP ETC. |
15.1 |
Winding up |
No order has been made, petition presented or resolution passed for the winding up of the Company or for the appointment of a liquidator or provisional liquidator to the Company.
15.2 |
Administration |
No administrator has been appointed in relation to the Company. So far as the Warrantors are aware, no notice has been given or filed with the court of an intention to appoint an administrator. No petition or application has been presented or order made for the appointment of an administrator in respect of the Company.
15.3 |
Receivership |
No receiver or administrative receiver has been appointed, nor any notice given of the appointment of any such person, over the whole or part of the Companys business or assets.
15.4 |
Moratorium |
No moratorium has been sought or has been granted under section 1A of the Insolvency Act 1986 in respect of the Company.
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15.5 |
Voluntary arrangements |
No voluntary arrangement has been proposed under section 1 of the Insolvency Act 1986 in respect of the Company.
15.6 |
Scheme of arrangement |
No compromise or arrangement has been proposed, agreed to or sanctioned under Part 26 (Arrangements and Reconstructions) of the Act in respect of the Company, nor has any application been made to, or filed with, the court for permission to convene a meeting to vote on a proposal for any such compromise or arrangement.
15.7 |
Informal arrangements with creditors |
The Company has not proposed or agreed to a composition, compromise, assignment or arrangement with any of its creditors.
15.8 |
Inability to pay debts |
The Company is not unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986. There are no unsatisfied written demands that have been served on the Company pursuant to section 123(1)(a) of the Insolvency Act 1986. There is no unsatisfied judgment or court order outstanding against the Company.
15.9 |
Payment of debts |
The Company has not stopped payment of, nor is it unable to pay, its debts as they fall due, nor has the Company commenced negotiations with one or more of its creditors with a view to rescheduling or restructuring any of its indebtedness.
15.10 |
Distress |
No distress, execution, attachment, sequestration or other process has been levied on an asset of the Company which remains undischarged.
15.11 |
Striking out |
No action is being taken by the Registrar of Companies to strike the Company off the register under section 1000 of the Act.
15.12 |
Analogous proceedings |
The Company is not, in any jurisdiction, subject to or threatened by any other procedures or steps which are analogous to those set out above.
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16. |
COMPETITION |
So far as the Warrantors are aware, the Company has not failed to comply with or infringed the competition laws or regulations of any jurisdiction or been investigated for alleged non-compliance or infringement or given any undertaking in connection therewith.
17. |
LITIGATION AND COMPLIANCE WITH LAW |
Nothing in this Warranty concerns any matters concerned with any Intellectual Property. For the purposes of this paragraph 12:
Agent means, with respect to an entity, any director, officer, employee or other representative of such entity; any person for whose acts such entity may be vicariously liable; and any other person that acts for or on behalf of, or provides services for or on behalf of, such entity, in each case, whilst acting in his capacity as such;
17.1 |
Litigation |
17.1.1 |
Neither the Company nor, so far as the Warrantors are aware, a person for whose acts or defaults the Company may be vicariously liable is involved, or has been involved, in a civil, criminal, arbitration, administrative or other proceeding. The Company has not received written notice that any civil, criminal, arbitration, administrative or other proceeding is pending or threatened by or against the Company or the assets or properties of the Company, or any of the directors, officers or employees of the Company (in their capacities as such or relating to their employment, services or relationship with the Company) or, so far as the Warrantors are aware, a person for whose acts or defaults the Company may be vicariously liable. So far as the Warrantors are aware, there is no reasonable basis for any action, suit, proceeding, claim, mediation, arbitration or investigation against the Company or the assets or properties of the Company, or any of the directors, officers or employees of the Company (in their capacities as such or relating to their employment, services or relationship with the Company) or a person for whose acts or defaults the Company may be vicariously liable. |
17.1.2 |
There is no outstanding judgment, order, decree, arbitral award or decision of a court, tribunal, arbitrator or governmental agency against the Company, any of its assets or properties, or a person for whose acts or defaults the Company may be vicariously liable. |
17.1.3 |
So far as the Warrantors are aware, there is no reasonable basis for any Person to asset a claim against the Company based upon the Company entering into this Agreement or any of the Transaction Documents. |
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17.2 |
Compliance with law |
17.2.1 |
The Company has conducted its business and dealt with its assets in all material respects in accordance with applicable legal and administrative requirements. |
17.2.2 |
The Company has obtained each governmental consent, license, permit, grant, or other authorization of a governmental entity that is required for the operation of the Companys business or the holding of its assets or properties (all of the foregoing consents, licenses, permits, grants, and other authorizations, collectively, the Company Authorizations) and all of the Company Authorizations are in full force and effect. The Company has not received any notice or other communication from any governmental entity regarding (i) any actual or possible violation of law or of any Company Authorization or any failure to comply with any term or requirement of any Company Authorization or (ii) any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any Company Authorization. None of the Company Authorizations will be terminated or impaired, or will become terminable, in whole or in part, as a result of the consummation of the transactions contemplated by this Agreement. |
17.3 |
Investigations |
There is not and has not been any governmental or other investigation, enquiry or disciplinary proceeding concerning the Company that the Company has been notified of and, so far as the Warrantors are aware, none is pending or threatened.
17.4 |
Making unlawful payments |
Neither the Company nor, so far as the Warrantors are aware, any of its Agents has paid, offered, promised, given or authorised the payment of money or anything of value directly or indirectly to any person:
17.4.1 |
intending to induce a person to improperly perform a function or activity or to reward a person for any such performance; or |
17.4.2 |
while knowing or believing that the acceptance by that person would constitute the improper performance of a function or activity. |
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17.5 |
Receiving unlawful payments |
Neither the Company nor so far as the Warrantors are aware, have any of its Agents has directly or indirectly requested, agreed to receive or accepted money or anything of value:
17.5.1 |
as a reward for the improper performance of a function or activity by any person; |
17.5.2 |
in circumstances which amount to an improper performance of a function or activity; or |
17.5.3 |
intending that as a consequence of any such request, agreement to receive or acceptance a function or activity will be performed improperly. |
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SCHEDULE 8
Limitations on Sellers Liability
1. |
LIMITATION ON QUANTUM |
1.1. |
No Warrantor shall be liable in respect of [***] unless and until the amount that would otherwise be recoverable from the Warrantors (in aggregate) in respect of [***], when aggregated with any other amounts recoverable in respect of [***] exceeds [***] (the Threshold), in which case the Warrantors shall be liable [***]. |
1.2. |
The total aggregate liability of the Warrantors in respect of [***] shall be limited in accordance with clause 6.3. |
1.3. |
The liability in respect of each Seller in respect of [***] shall be limited to a maximum amount equal to [***] of the aggregate of the Total Consideration paid to such Seller, except for [***] with respect to [***] set forth in [***], which shall be limited to a maximum amount of [***]. The liability in respect of each Seller in respect of [***] shall be limited to a maximum amount equal to [***], except in the case of [***], which shall be limited to a maximum amount of [***]. |
1.4. |
The liability of each Seller, in respect of [***] made against such Seller, and the liability of each Warrantor for [***] made against such Warrantor, shall be limited to a maximum amount equal to [***]. |
1.5. |
Subject to paragraph 4 of this Schedule 8, the aggregate liability of any Seller for all claims under this Agreement shall be limited to a maximum amount equal to [***]. |
2. |
TIME LIMITATIONS |
2.1. |
No Seller, in respect of [***], or Warrantor, in respect of [***], shall be liable for such Claim (as the case may be) unless the Buyer has given the Sellers Representative and each Warrantor notice of such Claim (as the case may be), which notice shall state in reasonable detail the nature of the Claim, the grounds on which it is based (including which Warranty has or Warranties have been breached) and a good faith estimate of the amount claimed and must be notified to the Sellers Representative or Warrantor (as the case may be): |
(a) |
on or before the date that is [***] after the Completion Date in respect of [***]; |
(b) |
on or before [***] in respect of [***]; or |
(c) |
on or before [***] in respect of [***]. |
2.2. |
No Seller shall be liable for [***] or Warrantor shall be liable for [***] unless proceedings in respect of such Claim (as the case may be) are issued and served on the Sellers Representative within a period of [***] starting on the day of the Buyers notification of such Claim pursuant to Section 2.1 above and provided that such Claim has not otherwise been satisfied, settled or withdrawn. |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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3. |
RECOURSE FOR [***] |
In the event that any Seller is liable to the Buyer in respect of [***] following the earlier of (i) exhaustion of the money standing to the credit of the Escrow Account and (ii) the Release Date, the Buyers [***] recourse for such liability shall be [***].
4. |
NO LIMITATION FOR FRAUD ETC. |
Nothing in this Schedule 8 shall have the effect of limiting or restricting any liability of any Seller or Warrantor in respect of a Claim arising as a result of any fraud, wilful misconduct or wilful concealment by or on behalf of that Seller or Warrantor.
5. |
RECOVERY ONLY ONCE |
The Buyer is not entitled to recover more than once in respect of any one matter giving rise to a loss or liability under this Agreement.
6. |
THIRD PARTY RECOVERY |
6.1. |
If the Sellers pay to a Buyers Group Undertaking an amount in respect of a Claim and a Buyers Group Undertaking subsequently recovers from another person an amount which is referable to the matter giving rise to the Claim: |
(a) |
if the amount paid by the Sellers in respect of the Claim is more than the Sum Recovered, the Buyer shall promptly pay to the Sellers the Sum Recovered; and |
(b) |
if the amount paid by the Sellers in respect of the Claim is less than or equal to the Sum Recovered, the Buyer shall promptly pay to the Sellers an amount equal to the amount paid by the Sellers. |
For the purposes of paragraph 6.1 of this Schedule 8, Sum Recovered means an amount equal to the total of the amount recovered from the other person plus any interest in respect of the amount recovered from that person less all reasonable costs incurred by a Buyers Group Undertaking in recovering the amount from the person.
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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6.2. If the Buyer or a Buyers Group Undertaking becomes aware that matters have arisen which will or could reasonably be expected to give rise to a Claim, the Buyer will (or will procure that the relevant Buyers Group Undertaking will) where practicable (and provided such information is not subject to confidentiality or is not privileged) disclose in writing to the Sellers Representative such information and documents relating to the Claim as the Sellers Representative may reasonably request (at the sole cost of the Sellers) and will consult with those Sellers to the extent practicable and have regard to their reasonable representations in respect of the resolution of the Claim.
7. |
ACCOUNTS |
The Sellers shall have no liability in respect of any Claim if and to the extent that any allowance, provision or reserve was made or otherwise reflected in the Accounts or the Completion Accounts in respect of the matter or circumstances giving rise to the Claim.
8. TAX
8.1. |
The Sellers shall not be liable in respect of [***] to the extent that: |
(a) |
it has been discharged or made good without cost or loss to the Buyer; or |
(b) |
it arises or is increased as a result of any increase in the rates of Tax announced after the date of this Agreement; or |
(c) |
it arises or is increased by virtue of the failure or omission by the Company or the Buyer to make any claim, election, surrender or disclaimer or give any notice or consent or do any other thing after Completion (otherwise than at the written request of the Sellers), the making, giving or doing of which was taken into account or assumed in computing any provision or reserve for Tax in the Completion Accounts; or |
(d) |
any Relief (other than a Relief which has been reflected or shown as an asset in the Completion Accounts, or has been taken into account in calculating any provisions for Tax in the Completion Accounts) is available to reduce or eliminate such Tax liability. |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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9. |
CHANGE IN LAW |
The Sellers shall not be liable in respect of any Claim to the extent that it arises, or its value is increased, as a result of a change in any law, legislation, rule or regulation (including any new law, legislation, rule or regulation) that comes into force or otherwise takes effect after the date of this Agreement.
10. |
VOLUNTARY ACTS |
10.1. |
The Sellers shall not be liable in respect of any Claim to the extent that the matter or circumstance giving rise to such Claim arises, occurs or is otherwise attributable to, or the Sellers liability pursuant to such Claim is increased as a result of: |
[***].
10.2. |
The Sellers shall not be liable in respect of any Claim to the extent that [***]. |
11. |
SET OFF |
11.1. |
Subject to the procedures set forth in paragraph 11.2 below, the Buyer shall be entitled to deduct from the Contingent Consideration payable to a Seller or Sellers when it becomes due and payable in accordance with the provisions of Schedule 5 (Contingent Consideration), an amount equal to any Claim which may exist at the date upon which the Contingent Consideration falls due to be paid by the Buyer; provided, however, that in respect of [***], the Buyer may only deduct or withhold from the Contingent Consideration payable to the Sellers the proportion of the Contingent Consideration (as notified by the Sellers Representative pursuant to clause 3.5 of the Agreement) that is due or becomes due to [***]. |
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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11.2. |
If in connection with a payment of Contingent Consideration that has become due and payable in accordance with the provisions of Schedule 5 (Contingent Consideration), the Buyer in good faith believes that a Claim exists and the Buyer intends to make a deduction to such Contingent Consideration as permitted under paragraph 11.1 above, the Buyer shall, within three (3) Business Days following such payment becoming due and payable, deliver to the Sellers Representative and each Warrantor a notice in writing (a Set Off Notice) of such Claim, which Set Off Notice shall state in reasonable detail the nature of the Claim, the grounds on which it is based (including which Warranty has or Warranties have been breached) and a good faith estimate of the amount claimed (the Set Off Claim). If the Sellers Representative wishes to dispute the Set Off Claim on behalf of the Sellers or any Seller, it may, within twenty (20) Business Days of receipt of the Set Off Notice, indicate the same by written notice to the Buyer (the Set Off Dispute Notice) which also shall state in reasonable the basis for the Sellers Representatives dispute and the grounds on which it is based, in which case, either the Buyer or the Sellers Representative may then elect to initiate an alternative dispute resolution proceeding pursuant to the procedures set forth in clause 23.3 for purposes of having the Set Off Claim settled (a Set Off ADR) |
11.3. |
Promptly following timely receipt of the Set Off Dispute Notice, the Buyer shall deposit the applicable Contingent Consideration into escrow with SunTrust Bank or another escrow agent mutually acceptable to the Buyer and the Sellers Representative. The applicable Contingent Consideration shall be released from escrow and paid in accordance with the decision of the arbitrators in such Set Off ADR. |
11.4. |
For the avoidance of doubt, the set-off right set out in this paragraph 11 shall not apply to [***]. |
12. |
[***] |
[***].
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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13. |
CONDUCT OF THIRD PARTY CLAIMS |
13.1. |
The provisions of this paragraph 13 shall apply in the event that any third party brings or makes (or threatens to bring or make) any claim, demand, action or proceedings against any of the Buyer or a Buyers Group Undertaking which may reasonably be considered likely to give rise to a Claim (a Third Party Claim). |
13.2. |
In the event of a Third Party Claim, the Buyer shall: |
(a) |
as soon as reasonably practicable [***] give written notice of the Third Party Claim to the Sellers Representative, specifying in reasonable detail the nature of the Third Party Claim; |
(b) |
permit the Sellers Representative to participate in the defence of (but not conduct or control) such Third Party Claim at the expense of the Sellers Representative; |
(c) |
keep the Sellers reasonably informed (through the Sellers Representative) of the progress of, and all material developments in relation to, the Third Party Claim; |
(d) |
provide the Sellers Representative with copies of all material information and correspondence relating to the Third Party Claim; and |
(e) |
give (and cause each relevant Buyers Group Undertaking to give) the Sellers Representative and/or its professional advisers access at reasonable times (and on reasonable prior notice) to its premises and personnel, and to any relevant assets, accounts, documents or records within its control, for the purposes of enabling the Sellers to assess the Third Party Claim and to exercise their rights under this paragraph 13.2. |
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13.3. |
The Buyer shall have the right in its sole discretion to conduct the defence of and to settle or resolve such Third-Party Claim. However, without the prior written consent of the Sellers Representative, which consent will not be unreasonably withheld, delayed or conditioned [***]. In the event that the Sellers Representative has consented in writing [***], neither the Sellers Representative nor any Seller shall have any power or authority to object [***]. |
13.4. |
The Sellers shall indemnify the Buyer in respect of all costs, charges and expenses that are reasonably and properly incurred by the Buyer (or any other member of the Buyers Group) in connection with the defence of a Third Party Claim. |
14. |
PROVISION OF INFORMATION |
If, at any time after the date of this Agreement, a Seller wants to insure against its liabilities in respect of a Claim, the Buyer shall provide such information and assistance as a prospective insurer may reasonably require before effecting the insurance.
15. |
PRESERVATION OF INFORMATION |
The Buyer shall, and shall ensure that each Buyer Group Company will, use reasonable endeavours to preserve all documents, records, correspondence, accounts and other information whatsoever relevant to a matter which may give rise to a Claim.
16. |
RELEASING SELLER FROM LIABILITY |
The Buyer may release or compromise in whole or in part the liability of any of the Sellers under this Agreement or grant any time or indulgence to that Seller without affecting the liability of any other Seller.
17. |
CONTINGENT LIABILITIES |
If any potential Claim arises as a result of a contingent or unquantifiable liability of any Buyers Group Undertaking, each Seller will not be obliged to pay any sum in respect of the potential Claim until the liability either ceases to be contingent or becomes quantifiable;
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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provided, however, that this paragraph 17 shall not restrict the Buyer from setting off and deducting the Buyers reasonable estimate of any such potential Claim from Contingent Consideration, as permitted by paragraph 11.
EXECUTED and DELIVERED as a DEED by DENALI THERAPEUTICS INC. acting by an authorised officer |
) ) ) |
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/s/ Steve Krognes |
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EXECUTED and DELIVERED as a DEED by SHAREHOLDER REPRESENTATIVE SERVICES LLC. acting by an authorised officer |
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In the presence of: |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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EXECUTED and DELIVERED as a DEED by [***] an authorised signatory of ATLAS VENTURE ASSOCIATES VII, INC. acting in its capacity as general partner of ATLAS VENTURE ASSOCIATES VII, L.P. acting in its capacity as general partner of ATLAS VENTURE FUND VII, L.P. |
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In the presence of: |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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EXECUTED and DELIVERED as a DEED by [***] an authorised signatory of AESCAP VENTURE MANAGEMENT B.V. acting as manager of COÖPERATIVE AESCAP VENTURE I U.A. |
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In the presence of: |
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EXECUTED and DELIVERED as a DEED by TVM LIFE SCIENCE VENTURES VI GMBH & CO. KG acting by , authorised signatory | ||||
In the Presence of: |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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EXECUTED and DELIVERED as a DEED by , authorised signatory of TVM LIFE SCIENCE VENTURES VI CAYMAN LIMITED acting as a general partner of TVM LIFE SCIENCE VENTURES VI LIMITED PARTNERSHIP |
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EXECUTED and DELIVERED as a DEED by MP HEALTHCARE VENTURE MANAGEMENT, INC. acting by , an authorised signatory | ||||
In the Presence of: |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
91
EXECUTED and DELIVERED as a DEED by MERCK VENTURES B.V. acting by , an authorised signatory | ||||
In the Presence of: |
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EXECUTED and DELIVERED as a DEED by S.R. ONE, LIMITED acting by [***], a duly authorised officer | ||||
In the Presence of: |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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EXECUTED and DELIVERED as a DEED by [***] | ||||
In the Presence of: |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
93
Exhibit 10.33
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
AGREEMENT
THIS AGREEMENT is made the 6th day of March 2018 (Effective Date)
BETWEEN
1. |
IONTAS LIMITED, a company incorporated under the laws of England (Company No. 06785483) with its registered office at 82B High Street, Sawston, Cambridgeshire CB22 3HJ (Iontas) |
2. |
F-STAR BETA LIMITED, a company incorporated under the laws of England (Company No. 09263520) with its registered office at Eddeva B920 Babraham Research Campus, Cambridge. Cambridgeshlre CB22 3AT (F-star) |
BACKGROUND
1. |
lontas is a private biotechnology company focused on the development of novel antibody therapeutics through the use of its proprietary antibody phage display platform. |
2. |
F-star is a private biotechnology company focused on the design and development of antibody products. |
3. |
F-star has previously evaluated certain of lontas proprietary anti-PD-L1 antibodies under the terms of a Material Transfer Agreement dated 30 October 2017. |
4. |
F-star now wishes to acquire certain rights and title in lontas anti-PD-L1 antibodies for incorporation into F-stars proprietary product development programmes, and lontas is willing to assign such rights and license associated know-how to F-star on an exclusive basis, all in accordance with the terms and conditions of this Agreement. |
AGREED TERMS
1. |
DEFINITIONS |
1.1 |
In this Agreement unless the context otherwise requires, the definitions and rules of interpretation set out in this clause 1 shall apply. |
1.2 |
Affiliate means, with respect to a company or person, any other company or person that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such company or person; control and, with correlative meanings. the terms controlled by and under common control with, shall mean: (a) the possession, directly or |
indirectly, of the power to direct the management or policies of a company or person, whether through the ownership of voting securities, by contract or otherwise; or (b) the ownership, directly or indirectly, of at least fifty per cent (50%) of the outstanding voting securities or other ownership interest of a company or person. |
1.3 |
Antibodies means the set of proprietary antl·PD-L1 human antibodies that is the subject of this Agreement, each constituent antibody comprising: (a) one variable heavy (VH) sequence; and {b) one variable light (VL) sequence; selected from lontas proprietary VH and VL sequences set out in the Schedule. |
1.4 |
Antibody Know-how means all Know-how Controlled by lontas relating to the Antibodies or Related Sequences, Including without limitation: |
a. |
information relating to the Isolation of the Antibodies or Related Sequences, in particular information concerning the libraries, antigens, selection and screening methods used for such isolation; |
b. |
information relating to the methods and materials used in any assays in relation to the Antibodies or Related Sequences; and |
c. |
information relating to characterisation of the Antibodies or Related Sequences. including but not limited to details relating to their binding, specificity, functional activity. |
1.5 |
Calendar Year means the period from 1st January until 31st December; |
1.6 |
Control means the possession of the right (directly or indirectly, and by ownership, licence or otherwise) to grant a licence or other right as required in this Agreement, to or under lntellectual Property Rights, without violating the terms of any agreement or other arrangement with any third party. |
1.7 |
Exploit means to research. have researched, develop, have developed, register, have registered, use, have used, make, have made, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold, offer for sale, modify, enhance. improve, trial, formulate. optimise, transport, promote, otherwise dispose of or offer to dispose of or otherwise exploit, a compound, antibody or product, and Exploitation and Exploiting shall be construed accordingly. |
1.8 |
First Approval means the first approval (excluding conditional approval) granted by a Regulatory Authority which. provides authorisation to market and sell the relevant Product. |
1.9 |
Intellectual Property Rights means all patents. trademarks, service marks, designs, applications for any of the foregoing and the right to apply for any of the foregoing in any part of the world, copyright, design right. database rights, inventions, confidential information, Know-how and any other similar right anywhere in the world. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.10 |
Know-how means confidential information of either party comprising data, knowledge, Information, Ideas, discoveries, Inventions, formulae, techniques, procedures and methodologies for experiments and tests, designs, sketches, records, chemical manufacturing data, toxicological data, pharmacological data, pre-clinical data, clinical data, regulatory documentation, assays, platforms, formulations, specifications and quality control testing data; together with analyses and interpretations of information which is in the public domain. |
1.11 |
mAb2 means a full-length antibody in which the Fc region has been replaced by an Fc fragment wherein the Fc harbours an engineered antigen binding site. |
1.12 |
Phase 1 means a clinical study of a Product, the purpose of which is to study the pharmacology of the Product when administered to humans, and where the parties have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the clinical trial. |
1.13 |
Phase 2 means a clinical study of a Product, which provides for the Initial trial of the Product on a limited number of patients for the purpose of determining dose and evaluating safety .and preliminary efficacy in the proposed therapeutic indication. A clinical study which meets the definition of a Phase 3 shall not constitute a Phase 2 clinical study. |
1.14 |
Phase 3 means a controlled pivotal clinical study of a Product that aims to establish the therapeutic benefit of the Product in a larger patient sample and to further demonstrate the Products safety in patients with the target disease in a particular indication in a manner sufficient to obtain !hose regulatory approvals necessary from one or more competent authorities for the marketing and sale of the Product. |
1.15 |
Product means any product containing an Antibody and/or any antibody having a Related Sequence, regardless of such products specificity, itntended use, finished form, formulation, dosage or other active and non-active ingredients. |
1.16 |
Start means the first dosing of a first patient. |
1.17 |
Regulatory Authority means any competent authority in any country or region which regulates medicines and healthcare and life sciences products, including the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and the US Food and Drug Administration. |
1.18 |
Related Sequence means any antibody sequence that: (a) binds PD-L1; and (b) shares the same VH and VL germline sequences of the Antibodies; and (c) shares at least [***] homology within the combined CDR3 regions of such VH and VL germline sequences. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
2. |
ASSIGNMENT AND LICENCE |
2.1 |
Subject to the terms of this Agreement, lontas hereby assigns and transfers to F-star all of lontas right, title and interest in and to the Antibodies, including: |
2.1.1 |
the right to apply for, prosecute and obtain patent, utility model or other similar protection in respect of the Antibodies, Related Sequences and/or the Antibody Know-how; and |
2.1.2 |
the right to sue for damages and other remedies in respect of any infringement of such rights or use of the Antibodies, Related Sequences and/or the Antibody Know-how by any third party. |
2.2 |
Subject to the terms of this Agreement, lontas hereby grants to F-star an exclusive (even as to lontas and its Affiliates) right and licence, with the right to grant sublicences (including through multiple tiers}, under the Antibody Know-how to Exploit Related Sequences and Products throughout the world. |
2.3 |
Without prejudice to any other provision of this Agreement, in, the event that lontas or its Affiliates come into the Control of any lntellectual Property Rights directly related to the Antibody or Related Sequence, lontas hereby grants and agrees to grant (and shall procure the same from its Affiliates) to F-star a perpetual, irrevocable, non-exclusive, fully-paid up, worldwide, transferable, sub-licensable (including through multiple tiers} licence under such Intellectual Property Rights to research, develop, make, keep, use and sell any Antibody, Related Sequence or Products. |
2.4 |
lontas shall not Exploit the Antibodies, any Related Sequences, or any Products and shall not provide any Antibodies or Related Sequences to any third party. lontas shall not, and shall procure that its Affiliates do not file any application tor any patent, utility model or other similar protection in respect of the Antibodies, Related Sequences and/or the Antibody Know-how. lontas or its Affiliates shall not use the Antibodies or Related Sequences to create any derivative anti-PD-L1 antibodies (Derivatives). For the avoidance of doubt this includes chain shuffling to identify novel partner chains and mutagenesis of Antibodies or Related Sequences. For the avoidance of doubt. nothing In this Agreement shall prevent lontas from using the Antibody Know-how in research and development activities carried out on its own behalf and/or on behalf of third parties, provided that such activities are confined to the identification and Exploitation of: (a) antibodies against targets other than PD-L1; and (b) anti-PD-L1 antibodies that do not contain any of the Antibodies or Related Sequences. |
2.5 |
Except as expressly set forth in this Agreement, neither party grants to the other any licence, express or implied, under any of its Intellectual Property Rights, |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
2.6 |
lontas shall, within a reasonable period following receipt of a request from F-star, to the extent that it has not already done so, deliver up to F-star copies of the Antibody Know-how in a format to be agreed In writing between the parties. |
2.7 |
F-star shall be exclusively responsible for all regulatory matters (including the preparation and filing of all regulatory documentation) relating to the Exploitation of Products. |
3. |
COMMERCIAL TERMS |
3.1 |
In consideration of the assignment and licensing of lontas rights set out in clause 2 above, F-star undertakes to pay to lontas the recurring and non-recurring milestone payments set out in this clause 3. |
3.2 |
Each of the non-recurring milestone payments set out in the table below shall be payable by F-star once only, upon the first occurrence of the corresponding trigger event: |
Non-Recurring Milestone Payments
No. |
Trigger Event |
Payment Value | ||||
1 |
Up-front fee | £ | 200,000 | |||
[***] | [***] | [***] | ||||
[***] | [***] | [***] | ||||
[***] | [***] | [***] |
3.3 |
An annual fee of £50,000 shall be payable by F-star on the first, and each subsequent anniversary of the Effective Date occurring prior to the first commercial sale or supply by F-star, its Affiliates, licensees or sublicensees of any Product. |
3.4 |
Each of the recurring milestone payments set out in the table below shall be payable by F-star upon each occurrence of the corresponding trigger event in respect of each Distinct Product. Each of the recurring milestone payments set out in the table below shall be payable only once with respect to each Distinct Product regardless of whether the corresponding milestone is achieved more than once. For the purposes of this clause a Distinct Product·shall mean a Product containing an antibody or mAb2, the amino acid sequence of which antibody or mAb2 (as applicable) is different from the amino acid sequence of all other antibodies and mAb2 (as applicable) contained in all Products for which the applicable trigger event has previously occurred. |
Recurring Milestone Payments
No. |
Trigger Event |
Payment Value | ||||
[***] |
[***] | [***] | ||||
[***] |
[***] | [***] | ||||
[***] |
[***] | [***] | ||||
[***] |
[***] | [***] |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
No. |
Trigger Event |
Payment Value | ||||
[***] |
[***] | [*** | ] | |||
[***] |
[***] | [*** | ] | |||
[***] |
[***] | [*** | ] | |||
[***] |
[***] | [*** | ] | |||
[***] |
[***] | [*** | ] | |||
[***] |
[***] | [*** | ] |
3.5 |
For the purposes of recurring milestones 8, 9 and 10, the phrase net sales means [***]. |
3.6 |
lontas shall be entitled to issue its invoices in respect of non-recurring milestone payment No. 1 (Up-front Fee) and the Annual Fee (pursuant to clause 3.3) at any time following, respectively, the Effective Date and each subsequent anniversary of the Effective Date. Save as aforesaid, upon the first occurrence of the trigger event for each non-recurring milestone payment, and upon each occurrence of the trigger event for each recurring milestone payment, F-star shall notify lontas in writing within [***] after such occurrence. lontas shall be entitled to issue its invoice in respect of the relevant milestone payment at any time following receipt of such notice. F-star shall pay each lontas invoice, together with any applicable VAT, in full and without any set-off within [***] after receipt of the applicable invoice. |
3.7 |
If any milestone event listed in clause 3.4 does not occur in respect of a particular Distinct Product (Missed Milestone), then the milestone payment in respect of the Missed Milestone shall be paid together with the milestone payment in respect of the next milestone achieved with respect to the relevant Distinct Product (where next refers to the sequences. in which the milestones are listed in clause 3.4), except that recurring milestones [***] shall never be deemed to be Missed Milestones to which this clause 3.7 applies, and such milestones [***], shall be paid only upon actual achievement of the applicable milestone event. |
3.8 |
Payments of milestone payments under this clause 3 shall be made by F-star irrespective of whether F-star or its Affiliate, licensee, sub-licensee Is responsible for achieving the applicable trigger event. |
4. |
RECORDS |
4.1 |
F-star shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating or confirming the sums payable by F-star pursuant to this Agreement. lontas shall have the right to engage an independent public accountant to perform, on behalf of lontas. an audit of such books and records of F-star as may be deemed necessary by such independent public accountant for the period or periods requested by lontas and the correctness of any report or payments made |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
pursuant to this Agreement, provided that (i) such right shall not be exercised more than once in any Calendar Year. (ii) shall relate only records for the period not exceeding [***] prior to the current Calendar Year; and (iii) shall only take place upon reasonable notice and during the business hours of F-star. The accountant shall be required to keep confidential all information learnt during any such audit. and to disclose to lontas only such details as may be necessary to report on the accuracy of any report or payments made pursuant to this Agreement. |
4.2 |
F-star shall, at the reasonable request and at the cost of lontas audit its licensees and provide lontas access to such audit reports, provided that lontas shall keep confidential all information learnt from such reports on the terms of this Agreement. |
4.3 |
If lontas audit reveals an underpayment. F-star shall make up such underpayment with the next due payment. If the underpayment of F-star exceeds [***], then F-star shall pay the audit costs. |
5. |
WARRANTIES |
5.1 |
Each party warrants to the other that it has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder. and is not subject to any obligations that would prevent it from entering into or carrying out its obligations under this Agreement. |
5.2 |
lontas warrants that as at the Effective Date: |
5.2.1 |
to the best of lontas knowledge and belief, lontas is the sole legal and beneficial owner of the Antibodies and Related Sequences and has no knowledge of any third party having any right, title or interest in or to use the Antibodies or Related Sequences; |
5.2.2 |
lontas has not assigned, nor has lontas granted any licences under, the Antibodies or Related Sequences: |
5.2.3 |
lontas has not disclosed the sequences of the Antibodies or Related Sequences to any third party other than under conditions that such third parties shall not use nor disclose such information for any purpose other than discussions with lontas; |
5.2.4 |
lontas has the right to grant the rights and licences granted under this Agreement (including, without limitation, with respect the Antibody Know-how), without violating the terms of any agreement or other arrangement with any third party; and |
5.2.5 |
neither lontas nor any of its Affiliates has filed any patent application claiming any Antibodies or Related Sequences. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.3 |
All other warranties, representations, conditions and all other terms implied by statute or common law are, to the fullest extent permitted by applicable law, excluded from this Agreement. |
6. |
LIABILITY |
6.1 |
The following provisions set out the entire financial liability of the parties (including any liability for the acts or omissions of its employees, agents and sub-contractors) in respect of: (a) any breach of this Agreement: and (b) any representation, statement or tortious act or omission (including negligence) arising under or in connection with this Agreement. |
6.2 |
Neither party shall be liable, whether in contract, tort {including for negligence or breach of statutory duty), misrepresentation or otherwise for any special, indirect or consequential loss or damage. |
6.3 |
Save as expressly set out in this Agreement, the total aggregate liability of each party under this Agreement arising in connection with the performance or contemplated performance of this Agreement, whether In contract, tort (including negligence or breach of statutory duty), misrepresentation, restitution or otherwise shall be limited to [***]. |
6.4 |
Nothing in this Agreement limits or excludes F-stars liability under clause 6.5 below, nor a partys liability: (a) for death or personal injury caused by its negligence; (b) for fraud or fraudulent misrepresentation; or (c) for any other liability that cannot lawfully be excluded or limited. |
6.5 |
F-star acknowledges that lontas has no control over F-stars Exploitation of Products. Consequently, subject to clause 6.6, F-star agrees to indemnify lontas against all costs, claims, damages, losses, liabilities and expenses incurred or suffered by lontas in connection with any third party claim, demand, action or suit against lontas as a result of F-stars Exploitation of Products, except to the extent that such third party claim, demand, action or suit against lontas arises out of or in connection with any breach of warranty by lontas. |
6.6 |
lontas shall provide prompt written notice to F-star of the assertion or commencement of any third party claim, demand, action or suit F-star shall have the right to assume (with own counsel and at its own costs) the defence and/or settlement of the same and shall not be liable for any settlement made by lontas without F-stars consent (which consent shall not be withheld unreasonably). lontas shall (i) promptly provide all assistance and information reasonably required by F-star; (ii) not make any admission of liability, conclude any agreement or make any compromise with any person in relation to such claim, demand, action or suit without the prior written consent of F-star (which consent shall not be withheld unreasonably); and (iii) have the right to participate in (but not control) the defence of the claim, demand, action or suit and to retain its own counsel in connection with such claim, demand, action or suit at its own expense. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
7. |
CONFIDENTIALITY |
7.1 |
Each party agrees with the other that it will, except as permitted under this Agreement, maintain as confidential and will not make any unauthorised use of any private or confidential information about the other party including but not limited to information relating to its business, business plans or projections, members, customers, products, promotions, or its private and financial affairs. lontas agrees that it will maintain as confidential, not disclose to any third party and not use for any purpose any Antibodies or Related Sequences, except pursuant to clause 7.3 below. Notwithstanding the foregoing, F-star shall be free to use and disclose the Antibodies Related Sequences. and Antibody Know-how in connection with the Exploitation of Products. |
7.2 |
The provisions of clause 7.1 above shall not apply to: |
7.2.1 |
any information in the public domain, except where it has entered the public domain as a result of a breach of this Agreement or |
7.2.2 |
information obtained from a third party who is free to divulge the same without any obligation of confidentiality. |
7.3 |
Neither party shall be in breach of Its obligations under clause 7.1 to the extent that: |
7.3.1 |
information is required to be disclosed by law or in order for a party to this Agreement to meet its obligations hereunder; |
7.3.2 |
information is disclosed by F-star or lontas to its professional advisors, any regulatory authority or statutory auditors; or |
7.3.3 |
any disclosure is required by an order of any court of competent jurisdiction, or in pursuance of any procedure for disclosure of documents in any proceedings before any such court, or pursuant to any law or regulation having the force of law in any country. |
8. |
TERM AND TERMINATION |
8.1 |
This Agreement shall commence on the Effective Date and subject to clause 8.2 shall continue indefinitely thereafter. |
8.2 |
This Agreement may be terminated in any of the following circumstances: |
8.2.1 |
by F-star at any time upon [***] prior written notice to lontas; |
8.2.2 |
by either party immediately upon notice in writing to the other in the event that (i) the other party is in material breach of its obligations under this Agreement; and (ii) the terminating party has previously issued written notice specifying the breach and requiring its remedy; and (iii) at least [***] has elapsed following receipt of such notice by the party in breach, and during such period the party in breach has not remedied such breach; or |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
8.2.3 |
by either party immediately upon notice in writing in the event that the other party goes into compulsory or voluntary liquidation (except for the purposes of solvent reconstruction or amalgamation) or a receiver, administrative receiver or administrator is appointed in respect of the whole or any part of its assets or in the event that It makes an assignment for the benefit of or composition with its creditors generally or engages in or suffers any similar procedure in any jurisdiction. |
8.3 |
In the event of termination howsoever caused: |
8.3.1 |
F-star shall immediately cease all Exploitation of Products, and all use of the Antibody Know-how provided that F-star and its Affiliates, licensees, sub-licensees and third party partners shall be entitled to sell any stock of Products existing or in the process of manufacture as at the effective date of termination; |
8.3.2 |
Subject to clause 8.3.3 and only to the extent consistent with the rights granted under clause 8.3.3, lontas shall be entitled to Exploit Antibodies and Related Sequences (and F-star shall not enforce against lontas any Intellectual Property Rights generated by F-star relating solely to the Antibodies and Related Sequences) throughout the world as it sees fit without any further obligation to F-star and F-star shall, upon request, deliver to lontas in a format to be agreed in writing between the parties, all scientific and regulatory data and documents in F-stars possession and control to the extent that the same relate solely to the Antibodies and Related Sequences as developed by F-star up to the effective date of termination of this Agreement, to the extent necessary or desirable to enable lontas to take over and continue the Exploitation of the Antibodies and Related Sequences; and |
8.3.3 |
at the request of any licensee of F-star, lontas shall enter into a direct licence with such licensee on the same terms as this licence granted to F-star. |
8.4 |
In the event that F-star elects at any time to abandon, surrender or cease prosecution, maintenance or renewal of the entirety of any patent family, whether granted or pending, claiming only an Antibody or Related Sequence and no other antibody or antibody sequence or mAb2 (Abandonment). F-star shall notify Iontas in writing of its election prior to such Abandonment becoming effective, and F-star be deemed to have granted to lontas an exclusive option, exercisable within [***] or receipt of F-stars notice, to acquire from F-star, for nominal consideration only, the relevant patent family the subject of the Abandonment, provided however that with effect from the date of such assignment lontas hereby grants and agrees to grant to F-star a non-exclusive, fully-paid up, worldwide, transferable, sub-licensable (including through multiple tiers) licence under such patent family the subject of the Abandonment. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
8.5 |
The expiry or termination of this Agreement shall be without prejudice to any rights that have accrued to either of the parties under this Agreement. |
8.6 |
Clauses 1, 5. 6, 7. 8.3, 8.5, 9, 10 and 11 shall survive termination or expiry of this Agreement. |
9. |
NOTICES |
9.1 |
Any notice, consent, agreement or official communication under this Agreement shall be in writing and shall be delivered by hand or sent by pre-paid airmail post or recorded delivery post to the other party at its address as set out in this Agreement, or such other address as may have been notified by that party for such purposes. A notice, consent, agreement or official communication delivered by hand shall be deemed to have been received when delivered (or if delivery is not during business hours, at 09.00 on the first business day following delivery). A correctly addressed notice, consent, agreement or official communication sent by pre-paid airmail post or recorded delivery post shall be deemed to have been received at the time at which it would have been delivered in the normal course of post. |
10. |
DISPUTE RESOLUTION |
10.1 |
In the event of any dispute or difference arising out of or in connection with this Agreement which the parties cannot resolve by amicable negotiation within [***] of the onset of the dispute, the parties agree prior to any litigation first to try in good faith to settle the dispute or difference by mediation in accordance with the Mediation Rules published by the Centre for Dispute Resolution (CEDR). ln the absence of agreement as to the appointment of the mediator, the mediator shall be nominated by CEDR. The parties agree to bear equally the administrative costs of the mediation and the mediators fees. Each party further agrees to bear its own fees and costs. The venue for any mediation shall be England. Nothing in this Agreement shall prevent either party from seeking equitable relief (including without limitation injunctive relief) from any court of competent jurisdiction. |
11. |
GENERAL |
11.1 |
Each party agrees to execute, acknowledge and deliver such further instruments, and do such other acts, as may be necessary and appropriate in order to carry out the purposes and intent of this Agreement, including perfecting the transfer of title to those rights that are the subject of assignment pursuant to clause 2 above, and such agreements required pursuant to clause 8.3.3. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
11.2 |
Any variation of this Agreement shall be in writing and signed by or on behalf of the parties. |
11.3 |
Neither party shall have any liability to the other party under this Agreement if it is prevented from, or delayed in, performing its obligations under this Agreement or from carrying on its business by acts, events, omissions or accidents beyond its reasonable control. |
11.4 |
Except with respect to clause 8.3.3 which may be enforced by F-stars licensees, a person who is not a party to this Agreement shall not have any rights under or in connection with it, whether under the Contract {Rights of Third Parties) Act 1999 or otherwise. Notwithstanding that any term of this Agreement may be or become enforceable by a person who is not a party to it, the terms of this Agreement or any of them may be varied, amended or modified or this Agreement may be suspended, cancelled or terminated by agreement in writing between the parties or this Agreement may be rescinded (in each case), without the consent of any such third party. |
11.5 |
A waiver of any right under this Agreement is only effective if it is in writing and it applies only to the party to whom the waiver is addressed and the circumstances for which it is given. Unless specifically provided otherwise, rights arising under this Agreement are cumulative and do not exclude rights provided by law. |
11.6 |
If any provision of this Agreement is found by any court or administrative body of competent jurisdiction to be invalid, unenforceable or illegal, the other provisions shall remain in force. If any invalid, unenforceable or illegal provision would be valid, enforceable or legal if some part of it were deleted or modified, the provision shall apply with whatever modification is necessary to give effect to the commercial intention of the parties. |
11.7 |
F-star shall not, without the prior written consent of lontas, assign, transfer. charge or deal in any other manner with all or any of its rights or obligations under this Agreement. provided that F-star: (i) is permitted to license all or any of its rights or obligations under this Agreement,. and (ii) is permitted to assign all or any of its rights or obligations under this Agreement to an Affiliate and/or a purchaser of that part of F-stars business to which this Agreement relates. lontas may not at any time assign, transfer, charge, sub-contract or deal in any other manner with all or any of its rights or obligations under this Agreement, save that lontas may, without consent. assign the benefit of the payments from F-star under this Agreement, following prior written notice to F-star of such assignment. |
11.8 |
Nothing in this Agreement is intended to or shall operate to create a partnership between the parties, or to authorise either party to act as agent for the other, and neither party shall have authority to act in the name or on behalf of or otherwise to bind the other in any way (including but not limited to the making of any representation or warranty, the assumption of any obligation or liability and the exercise of any right or power). |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
11.9 |
This Agreement constitutes the entire and only agreement between the parties in relation to its subject matter and replaces and extinguishes all prior or simultaneous agreements, undertakings, arrangements, understandings or statements of any nature made by the parties or any of them whether oral or written (and, if written, whether or not in draft form) with respect to such subject matter. Each of the parties acknowledges that they are not relying on any statements, warranties or representations given or made by any of them in relation to the subject matter of this Agreement, save those expressly set out in this Agreement, and that they shall have no rights or remedies with respect. to such subject matter otherwise than under this Agreement save to the extent that they arise out of the fraud or fraudulent misrepresentation of another party. |
11.10 |
This Agreement and any disputes or claims arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) are governed by and construed in accordance with the laws of England. Subject to clause 10 above, the parties irrevocably agree that the courts of England have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with this Agreement or Its subject matter or formation (including non-contractual disputes or claims). |
AS WITNESS the duly authorised representatives of each of the parties the day and year first before written.
SIGNED by | ) | |||||
for and on behalf of | ) | ............................................ | ||||
IONTAS LIMITED | ) | |||||
SIGNED by | ) | |||||
for and on behalf of | ) | ............................................ | ||||
F-STAR BETA LIMITED |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
SCHEDULE
[***]
[***]
[***]
|
[***] |
|
[***] |
[***]
|
[***] |
[***]
[***]
[***]
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Exhibit 10.34
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
AMENDED AND RESTATED
PD-L1 LICENCE AGREEMENT
between
F-STAR BETA LIMITED
and
KYMAB LIMITED
Dated as of 26th day of November 2018
CONFIDENTIAL
Index
SCHEDULE 1 |
29 | |||||
SCHEDULE 2 |
31 | |||||
SCHEDULE 3 |
32 |
CONFIDENTIAL
This Agreement is made on 26th day of November 2018 by and between:
(1) |
F-STAR BETA LIMITED, an English limited company (company number 09263520) with its registered office at Eddeva B920, Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT (F-star); and |
(2) |
KYMAB LIMITED, an English limited company (company number 07027523) with its registered office at The Bennet Building (B930), Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT (Kymab). |
F-star and Kymab are sometimes referred to herein individually as a Party and collectively as the Parties.
RECITALS
(A) |
F-star Controls (as defined herein) certain intellectual property rights with respect to an Fcab directed specifically against PD-L1. Kymab has selected one such Fcab to be provided by F-star to Kymab; and |
(B) |
F-star, pursuant to an agreement between the Parties dated 19 April 2016, (the Original Agreement) has granted a limited licence to Kymab under its intellectual property rights in certain murine and human F-star PD-L1 F cabs selected by Kymab. The Original Agreement was amended by the Parties by a letter dated 17 May 2017; and |
(C) |
The Parties have agreed to amend and restate the Original Agreement insofar as it relates to the grant of the limited licence by F-star to Kymab under its intellectual property rights in the PD-L1 Fcab selected by Kymab as further set out in this Agreement. |
NOW THEREFORE, in consideration of the following mutual promises and obligations, and for other good and valuable consideration the adequacy and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1. |
DEFINITIONS |
In this Agreement and in the Schedules to this Agreement the following capitalised terms, whether used in the singular or plural, shall have the meanings set forth below:
1.1 |
Affiliate means, with respect to a given entity, any person, corporation, or other entity, that Controls, is Controlled by, or is under common Control with such entity where for the purposes of this definition Control shall mean in respect of any corporation or other entity, the direct or indirect ownership of more than fifty percent (50%) of the outstanding shares or other voting rights of the subject entity having the power to vote on or direct the affairs of the entity, (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction). Any other relationship which in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute Control. For the avoidance of doubt, F-star Alpha, F-star Gamma, F-star Delta, F-star GmbH and F-star |
1
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Ltd shall not be considered to be Affiliates of F-star. Any entity that is established by Kymab and that is Controlled by the shareholders of Kymab but not by Kymab itself shall not be considered to be an Affiliate of Kymab. |
1.2 |
Agreement means this agreement and all schedules, appendices and other addenda attached hereto as any of the foregoing may be amended in accordance with the provisions of this Agreement. |
1.3 |
Applicable Law means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder. |
1.4 |
Business Day means a day other than a Saturday or Sunday on which banking institutions in London, England are open for business. |
1.5 |
Calendar Quarter means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. |
1.6 |
Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. |
1.7 |
Combination Product means a Licensed Product containing or consisting of one (1) or more Kymab mAb2 together with one (1) or more Other Active Ingredients, whether in the same or different formulations. |
1.8 |
Commercialisation means any and all activities directed to the preparation for sale of; offering for sale of, or sale of a molecule or product, including activities related to marketing, promoting, distributing, importing and exporting such molecule or product, and, for purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting Phase IV Studies, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, to Commercialise and Commercialising means to engage in Commercialisation, and Commercialised has a corresponding meaning. |
1.9 |
Commercially Reasonable Efforts means, with respect to the performance of a Partys activities under this Agreement, the carrying out of such activities using efforts and resources comparable to the efforts and resources that [***] would typically devote to compounds or products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial, and other factors that the company would take into account, including issues of safety and efficacy, expected and |
2
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
actual cost and time to develop, expected and actual profitability (including royalties and other payments required hereunder), expected and actual competitiveness of alternative products (including generic or biosimilar products) in the marketplace, the nature and extent of expected and actual market exclusivity (including patent coverage and regulatory exclusivity), the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required. |
1.10 |
Confidential Information means any Information or data provided orally, visually, in writing or other form by or on behalf of one Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement before, on, or after the Effective Date, including Information relating to the disclosing Partys products, technology, research plans, business affairs and/or finances, the terms of this Agreement or any Licensed Product. |
1.11 |
Control means, with respect to any item of Information, Regulatory Documentation, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of the license and other grants in Clause 3.1), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party [***]. |
1.12 |
Data means the F-star PD-L1 Fcab Data. |
1.13 |
Effective Date means 19 April 2016. |
1.14 |
F-star Alpha means F-star Alpha Limited, an English limited company whose company number is 08676690 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT. |
1.15 |
F-star Background Patents means any and all F-star Patents which do not specifically claim the F-star Human PD-L1 Fcab or the sequence of CH3 domain containing the antigen binding loops in the F-star Human PD-L1 Fcab. |
1.16 |
F-star Delta means F-star Delta Limited, an English limited company whose company number is 10543154 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT; |
1.17 |
F-star Gamma means F-star Gamma Limited, an English limited company whose company number is 10214672 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT. |
1.18 |
F-star GmbH means F-star Biotechnologische Forschungs-Und Entwicklungsges.M.B. H, an Austrian company whose registered office is Schwarzenbergplatz 7, A-1030 Vienna, Austria. |
3
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.19 |
F-star Know-How means any F-star Know-How in relation to the F-star PD-L1 Fcabs that (i) is in F-stars Control on or prior to the Effective Date and/or (ii) is assigned to F-star pursuant to Clause 6.2. |
1.20 |
F-star Ltd means F-star Biotechnology Limited, an English limited company whose company number is 08067987 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT. |
1.21 |
F-star Patents means any and all Patents Controlled by F-star on the Effective Date or during the Term that have claims that would, in the absence of a licence, be infringed by the research, development or Commercialisation of a Kymab mAb2. F-star Patents specifically includes the claims of any Patent that covers the F-star PD-L1 Fcab that is Controlled by F-star, except for any Patent filed by Kymab in respect of the Kymab mAb2 pursuant to Clause 6.6. |
1.22 |
F-star PD-L1 Fcabs means the F-star Human PD-L1 Fcab and the F-star Murine PD-L1 Fcabs each as specifically identified in Schedule 1, Part A and under the headings F-star Human PD-L1 Fcab and F-star Murine PD-L1 Fcabs. |
1.23 |
F-star PD-L1 Fcab Data means the data that is in F-stars Control on or prior to the Effective Date, including that described in Schedule 1, Part B, solely in respect of the F-star PD-L1 Fcabs. |
1.24 |
Fab means the region on an antibody that binds to antigens which is composed of one (1) constant and one (1) variable domain of each of the heavy and the light chain. |
1.25 |
Fcab means an Fc fragment of an antibody that harbours an antigen binding site that confers a specific binding of such Fc fragment to a defined target antigen, which Fc fragment is generated by or on behalf of F-star. |
1.26 |
Field means all therapeutic, prophylactic and diagnostic uses, including the treatment of human and animal disease. |
1.27 |
First Commercial Sale means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after Regulatory Approval for such Licensed Product has been obtained in such country. [***]. |
1.28 |
ICOS means Inducible T-cell COStimulator (ICOS) (registered with Uniprot number Q9Y6W8), also known as CD278, encoded by the ICOS gene being part of the CD28-superfamily and a costimulatory molecule which is expressed on activated T-cells. |
1.29 |
Information means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, |
4
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed. |
1.30 |
Know-How means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions. |
1.31 |
Kymab Licensed Product means any product which contains the Kymab mAb2. |
1.32 |
Kymab mAb2 means a product comprising an antibody (a) in which the CH3 domain contains the antigen binding loops of the F-star Human PD-L1 Fcab and (b) which contains the antigen binding loops of a ICOS Fab. |
1.33 |
Licensed Product means a Kymab Licensed Product alone, or as part of a Combination Product, in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes, including any improvements thereto. |
1.34 |
Losses has the meaning set forth in Clause 9.2. |
1.35 |
mAb2 Patents means any Patents filed by Kymab that claim the composition of matter of a Kymab mAb2. |
1.36 |
Material Transfer Agreement means the material transfer agreement between F-star Ltd and Kymab dated 28 May 2015. |
1.37 |
Mono Product has the meaning set forth in the definition of Net Sales in Clause 1.39. |
1.38 |
Net Receipts means any payment (including any option fee, upfront payment, milestone, royalty or other consideration) received by Kymab from a Third Party in consideration for an option for rights, or the grant of rights, in respect of a Kymab Licensed Product which is received by Kymab whether before or after the date of this Agreement, less any value added or other taxes that are withheld from or which Kymab is liable to pay in relation to such receipt. |
1.39 |
Net Sales means, [***] |
(a) |
[***] |
(b) |
[***] |
(c) |
[***] |
5
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(d) |
[***] |
(e) |
[***] |
[***] |
|
[***] |
|
[***] |
|
[***] |
|
(i) |
[***] |
(ii) |
[***] |
(iii) |
[***] |
(iv) |
[***] |
1.40 |
Other Active Ingredient means an active pharmaceutical ingredient which has a therapeutic effect which is independent of the relevant Kymab mAb2. Drug delivery vehicles, adjuvants and excipients shall not be deemed to be active pharmaceutical ingredients and their presence shall not be deemed to create a Combination Product. For the avoidance of doubt, the Other Active Ingredient and the relevant Kymab mAb2 must be separate and distinct components of the Combination Product, and the presence of an antibody fragment or region within a trispecific Kymab mAb2 shall not be deemed to create a Combination Product. |
1.41 |
Patents means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b), and (c)), and (e) any similar patent rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents. |
1.42 |
PD-L1 means Programmed Death-Ligand 1 (registered with Uniprot number Q9NZQ7), also known as B7-H1 or CD274. |
1.43 |
PD-L1 Fcab means an Fcab directed specifically against PD-L1. |
6
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.44 |
Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. |
1.45 |
Phase 3 Clinical Trial means a clinical trial which is designed to (a) establish that the relevant product is safe and efficacious for its intended use: (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed and (c) support Regulatory Approvals. |
1.46 |
PoC Trial means the first phase 2 clinical trial that is reasonably designed to provide initial evidence of efficacy of the relevant product and it is not intended to be a pivotal clinical trial or a dose ranging study. |
1.47 |
Regulatory Approval means, with respect to a country or other jurisdiction in the Territory, any and all approvals, licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialise a Kymab mAb2 or Licensed Product in such country or other jurisdiction, including, where applicable pricing or reimbursement approval in such country or other jurisdiction. |
1.48 |
Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Commercialisation of any Kymab mAb2 or Licensed Products in the Territory. |
1.49 |
Royalty Term means with respect to each Kymab Licensed Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country, and ending on the first to occur of (a) the last to occur of the expiration, invalidation or abandonment of the last F-star Patent or mAb2 Patent as the case may be that includes a Valid Claim that covers the manufacture, sale, or use of the Kymab Licensed Product or the Kymab mAb2 in such country, and (b) the date that is ten (10) years from the date of the First Commercial Sale of such Licensed Product anywhere in the world. |
1.50 |
Sublicensee means a Third Party, other than a distributor, that is granted a sublicense by Kymab under the grants in Clause 3.1 as provided in Clause 3.3. |
1.51 |
Term has the meaning set forth in Clause 10.1. |
1.52 |
Territory means all countries and territories worldwide. |
1.53 |
Third Party means any Person other than F-star, Kymab and their respective Affiliates. For the avoidance of doubt, F-star Alpha, F-star Gamma, F-star Delta, F-star GmbH and F-star Ltd shall be deemed to be Third Parties. |
7
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.54 |
Valid Claim means a claim of any issued and unexpired Patent directed to patentable subject matter for which the validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal. |
1.55 |
This Agreement shall be interpreted and construed pursuant to the following rules of interpretation and construction: |
1.55.1 |
all references to a particular clause or schedule shall be a reference to that clause or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement; |
1.55.2 |
in the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control; |
1.55.3 |
the headings are inserted for convenience only and shall be ignored in construing this Agreement; |
1.55.4 |
words importing the masculine gender shall include the feminine; |
1.55.5 |
words denoting persons shall include any individual, partnership, company, corporation, joint venture, trust association, organisation or other entity, in each case whether or not having separate legal personality; |
1.55.6 |
the words include, included, including and in particular or any similar expression are to be construed as illustrative and without limitation to the generality of the preceding words; and |
1.55.7 |
reference to any statute or regulation includes any modification or re-enactment of that statute or regulation. |
2. |
SEQUENCES AND ALLIANCE MANAGER |
2.1 |
The sequences of the F-star PD-L1 Fcabs are recorded in Schedule 1 Part A. Within [***] of the Effective Date, F-star shall disclose the F-star PD-L1 Fcab Data to Kymab. In the event that F-star becomes aware that any of the F-star PD-L1 Fcab Data disclosed by it to Kymab may negatively affect Kymabs research or development activities pursuant to the licence granted under clause 3.1, F-star shall, to the extent that it is reasonably able to do so, promptly notify Kymab. |
2.2 |
Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an Alliance Manager). Each Party may replace its Alliance Manager at any time by notice in writing to the other Party. |
8
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
3. |
LICENCES |
3.1 |
F-star hereby grants to Kymab: |
3.1.1 |
an exclusive licence, under the F-star Patents (other than the F-star Background Patents) and the F-star PD-L1 Fcab Data {in the case of the Data being that existing at the Effective Date); and |
3.1.2 |
a non exclusive licence under the F-star Know-How and the F-star Background Patents; in each case with the right to grant sublicences (subject to Clause 3.3), to the extent necessary or desirable solely for the purpose of researching, developing, manufacturing, using and Commercialising Kymab Licensed Products in the Field in the Territory. It is acknowledged and agreed that the rights granted pursuant to this clause 3.1 under the F-star Know-how and F-star PD-L1 Fcab Data extend solely to the F-star Know-how and F-star PD-L1 Fcab Data that relate to, and the specific sequence of, the F-star Human PD-L1 Fcab set out in Schedule 2 Part A. |
3.2 |
F-star hereby grants to Kymab a non-exclusive licence to use the F-star Murine PD-L1 Fcab solely in combination with a ICOS monoclonal antibody and then solely for the purposes of evaluating the F-star Human PD-L1 Fcab in a Kymab Licensed Product. For the avoidance of doubt, Kymab does not have a licence to use the F-star Murine PD-L1 Fcab in any product whatsoever and Kymab does not have a licence to use the F-star Murine PD-L1 Fcab for the testing or development of any product other than a Kymab Licensed Product, and Kymab is not allowed to express the F-star Murine PD-L1 Fcab in the context of any Fab molecules other than an ICOS-specific Fab. It is acknowledged and agreed that the rights granted pursuant to this clause 3.2 extend solely to the specific sequence of the F-star Murine PD-L1 Fcab set out in Schedule 1 Part A. |
3.3 |
Kymab shall have the right to grant sublicences through multiple tiers of sublicences to Sublicensees; provided that any such sublicences shall (a) be in writing, (b) be not inconsistent with the terms and conditions of this Agreement, and (c) require the applicable Sublicensee to comply with all applicable terms of this Agreement. Each sublicence granted hereunder will terminate immediately upon the termination of the licence from F-star to Kymab with respect to such rights. |
3.4 |
Where this Agreement has been terminated after Kymab has granted a sub-licence to a Sublicensee, F-star shall, on the written request of the relevant Sublicensee, grant a licence to the Sublicensee on terms substantially similar to this Agreement but with the same scope as the relevant sub-licence. |
3.5 |
Notwithstanding the exclusive licences granted herein: |
3.5.1 |
Subject to clause 3.5.2, F-star retains the right for itself and its Affiliates to research, develop, manufacture, use and Commercialise any PD-L1 Fcab (including the sequences licensed in this agreement) in any product other than a Kymab mAb2 or Kymab Licensed Product, and to grant licences and sublicences (including through multiple tiers) to Third Parties under F-star Patents, F-star Know-How and the F-star PD-L1 Fcab Data to any PD-L1 Fcab for the purpose of researching, developing, manufacturing, using and Commercialising any product other than a Kymab mAb2 or Kymab Licensed Product. |
9
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
3.5.2 |
F-star and F-star Ltd shall not, shall procure that their Affiliates shall not, and shall not assist or enable any other Third Party, during the Term of this Agreement, to research, develop, manufacture, use or Commercialise any product comprising an antibody where the Fc fragment of the antibody harbours an antigen binding site that confers a specific binding of such Fc fragment to PD-L1 and which contains the antigen binding loops of a ICOS Fab. |
3.6 |
Except as expressly provided herein, F-star grants no other right or licence, including any rights or licences to any of its intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel or otherwise. |
3.7 |
F-star shall, if requested to do so by Kymab, promptly enter into confirmatory licence agreements in the form or substantially the form reasonably requested by Kymab for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as Kymab considers appropriate. |
4. |
DILIGENCE |
4.1 |
Kymab shall use Commercially Reasonable Efforts to develop and Commercialise a Kymab Licensed Product, save that in the event that Kymab ceases to develop or Commercialise a Kymab mAb2 for a period of [***] or more F-star may terminate the licence granted to Kymab pursuant to Clause 3.1 by notice in writing to Kymab. |
4.2 |
In the event that Kymab or a Sublicensee of Kymab has not initiated GMP manufacture of the Kymab mAb2 on or before 30 June 2018 then the restrictions (but not the rights) set out in clause 3.5.1 and the provisions of clause 3.5.2 shall expire and F-star and F-star Ltd shall no longer be subject to the restrictions therein. |
4.3 |
In the event that Kymab or a Sublicensee of Kymab has not dosed the first subject in a clinical trial on or [***], then the restrictions (but not the rights) set out in clause 3.5.1 and the provisions of clause 3.5.2 shall expire and F-star and F-star Ltd shall no longer be subject to the restrictions therein provided always that if the delay in Kymab having dosed the first subject in a clinical trial is for reasons outside Kymabs reasonable control the date to dose the first subject in such a clinical trial shall be extended to [***] before the restrictions (but not the rights) set out in clause 3.5.1 and the provisions of clause 3.5.2 expire and F-star and F-star Ltd no longer being subject to the restrictions therein. |
4.4 |
The expiry of the restrictions in clauses 3.5.1 and 3.5.2 shall be conditional upon F-star and F-star Ltd providing to Kymab such reasonable assistance by way of advice on know-how specifically relating to the mAb2 technology of F-star and F-star Ltd, at Kymabs reasonable cost, in relation to the development of the Kymab mAb2 provided always that (i) F-star shall not be obliged to disclose any information which is confidential to a Third Party or which has been exclusively licensed to a Third Party, or in breach of any agreement it has at the relevant time; (ii) such advice shall be limited to the information readily available to the personnel at F-star at the relevant time; and |
10
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(iii) F-star shall not be required to undertake any research or development work or to create information for Kymab. F-stars obligation to provide such advice shall be limited to [***]and shall expire on the earlier of initiation of [***] and [***]. |
4.5 |
Kymab shall have the exclusive right to prepare, obtain, and maintain any Regulatory Approvals and applications therefor (including the setting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities, for the Kymab mAb2 or Licensed Products in the Territory (which shall include filings of or with respect to INDs or CTAs and other filings or communications with the Regulatory Authorities). |
5. |
PAYMENTS AND RECORDS |
5.1 |
Subject to Clause 5.2, Kymab shall pay to F-star the percentage of its Net Receipts set out in the table below from a Sublicensee of a Kymab Licensed Product: |
Point at which the sub-licence is granted |
Proportion of Net Revenues
payable |
|||
[***] |
[*** | ] | ||
[***] |
[*** | ] | ||
[***] |
[*** | ] |
5.2 |
If: |
5.2.1 |
the entire issued share capital of Kymab is acquired by a Third Party (a) prior to the grant by Kymab of a sub-licence to a Sublicensee pursuant to clause 3.3; or (b) after the grant of such a sub-licence where the acquirer of the entire issued share capital of Kymab is the Sublicensee under the relevant sub-licence, Kymab shall make the following payments to F-star in place of the payments provided for in Clause 5.1: |
(i) |
[***]; |
(ii) |
[***]; |
(iii) |
[***]; |
(iv) |
[***]); |
(v) |
[***]); |
(vi) |
[***]; |
(vii) |
[***]; |
[***]
11
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.3 |
In the event that either Kymab sells Kymab Licensed Products or in the circumstances set out in Clause 5.2.1, then commencing upon the First Commercial Sale of a Licensed Product in the Territory and for the Royalty Term, on a Licensed Product-by-Licensed Product basis, Kymab shall pay to F-star [***] of Net Sales of each Kymab Licensed Product in the Territory. Kymab shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country or other jurisdiction after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. |
5.4 |
In the event that Kymab grants a sub-licence of rights in relation to a Licensed Product in the same or a related agreement or arrangement to the grant of any other rights Kymab shall promptly notify F-star of such grant and it is acknowledged and agreed that the amounts apportioned to the grant of rights in relation to such Licensed Product shall fairly reflect the proportionate value of such Licensed Product. In the event of disagreement between the Parties as to the apportionment either Party may refer the determination of the fair apportionment to an independent expert in accordance with the procedure set out in Schedule 3. |
5.5 |
Royalty Payments and Reports. Kymab shall calculate all amounts payable to F-star pursuant to this Clause 5 at the end of each Calendar Quarter, which amounts shall be converted to Pounds Sterling, in accordance with Clause 5.6. Kymab shall pay to F-star the royalty amounts due with respect to a given Calendar Quarter within [***] after the end of such Calendar Quarter. Each payment of royalties shall be accompanied by a statement of the amount of Net Sales of each Licensed Product in each country or other jurisdiction in the Territory during the applicable Calendar Quarter (including such amounts expressed in local currency and as converted to Pounds Sterling), the applicable royalty rate(s) under this Agreement and a calculation of the amount of royalty payment due on such Net Sales for such Calendar Quarter. |
5.6 |
Mode of Payment. All payments to F-star under this Agreement shall be made by deposit of Pounds Sterling in the requisite amount to such bank account as F-star may from time to time designate by notice to Kymab. For the purpose of calculating any sums due under this Agreement (including the calculation of Net Sales expressed in currencies other than Pounds Sterling), Kymab shall convert any amount expressed in a foreign currency into Pound Sterling equivalents using its, its Affiliates or Sublicensees standard conversion methodology consistent with recognised accounting standards (either International Financial Reporting Standards or US GAAP). |
5.7 |
Withholding Taxes. Where any sum due to be paid to F-star hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, Kymab shall remit such withholding or similar tax to the appropriate government authority, deduct the amount paid from the amount due to F-star and secure and send to Kymab the best available evidence of the payment of such withholding or similar |
12
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
tax. If withholding or similar taxes are paid to a government authority, each Party will provide the other such assistance as is reasonably required to obtain a refund of the withheld or similar taxes, or obtain a credit with respect to such taxes paid. |
5.8 |
Indirect Taxes. All payments in this Agreement are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the Indirect Taxes). If any Indirect Taxes are chargeable in respect of any payments, kymab shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by F-star in respect of those payments. F-star shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by Kymab are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by F-star to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to F-star will be transferred to Kymab within [***] of receipt. |
5.9 |
Financial Records. Kymab shall, and shall cause its Affiliates and Sublicensees to, keep complete and accurate books and records, including agreements, pertaining to Net Receipts and Net Sales of Licensed Products in sufficient detail to calculate all amounts payable hereunder and to verify compliance with its obligations under this Agreement. Such books and records shall be retained by Kymab and its Affiliates and Sublicensees until [***] after the end of the period to which such books and records pertain. |
5.10 |
Audit. At the request of F-star, Kymab shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognised standing designated by F-star and reasonably acceptable to Kymab, at reasonable times during normal business hours and upon reasonable notice, to audit the books and records maintained pursuant to Clause 5.9 to ensure the accuracy of all reports and payments made hereunder. Such examinations may not (a) be conducted for any Calendar Quarter more than [***] after the end of such Calendar Year to which such books and records pertain or (b) be conducted more than once in any [***] period (unless a previous audit during such [***]period revealed an underpayment with respect to such period). The accounting firm shall disclose to the Parties only whether the reports are correct or not, and the specific details concerning any discrepancies. No other information shall be shared with F-star. Except as provided below, the cost of this audit shall be borne by F-star, unless the audit reveals a variance of more than [***] from the reported amounts, in which case Kymab shall bear the cost of the audit. Unless disputed pursuant to Clause 5.11 below, if such audit concludes that (i) additional amounts were owed by Kymab, Kymab shall pay the additional amounts as provided in this Clause 5.10 or (ii) excess payments were made by Kymab, F-star shall reimburse such excess payments, in either case ((i) or (ii)), within [***]after the date on which such audit is completed by F-star. |
5.11 |
Audit Dispute. In the event of a dispute with respect to any audit under Clause 5.10, F-star and Kymab shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute shall be submitted for resolution in accordance with the provisions of Schedule 33 to a certified public accounting firm jointly selected by each Partys certified public |
13
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
accountants or to such other Person as the Parties shall mutually agree (the Audit Expert). The Audit Expert shall act as an expert and not as an arbitrator. The decision of the Audit Expert shall be final and the costs of such determination as well as the initial audit shall be borne between the Parties in such manner as the Audit Expert shall determine. Not later than [***] after such decision and in accordance with such decision, Kymab shall pay the additional amounts as provided in Clause 5.10, or F-star shall reimburse the excess payments, as applicable. |
5.12 |
Confidentiality. F-star shall treat all information subject to review under this clause 5 in accordance with the confidentiality provisions of clause 7 and the Parties shall cause the Audit Expert to enter into a reasonably acceptable confidentiality agreement with Kymab obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. |
6. |
INTELLECTUAL PROPERTY |
6.1 |
As between the Parties, F-star or an Affiliate designated by F-star shall Control all right, title, and interest in and to any and all F-star Patents, F-star Know-How and F-star PD-L1 Fcab Data. |
6.2 |
As between the Parties, (i) all Information and discoveries, inventions and improvements that are conceived, discovered, developed, or otherwise made by on or behalf of a Party (or its Affiliates or Sublicensees) under or in connection with this Agreement, whether or not patented or patentable, in each case that solely and exclusively relate to the F-star PD-L1 Fcabs shall be F-star Know-How and owned by F-star (regardless of inventorship), and (ii) any and all Patents with respect thereto shall be F-star Patents and owned by F-star (regardless of inventorship). Accordingly, Kymab will promptly disclose to F-star in writing, the conception, discovery, development or making of any such F-star Know-How or F-star Patents. Kymab, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), to F-star all its right, title and interest in and to any such F-star Know-How or F-star Patents. On F-stars request, Kymab will execute and record assignments and other necessary documents consistent with such ownership. |
6.3 |
Except as set forth in Clauses 6.1 and 6.2 above, as between the Parties, Kymab shall own and retain all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of Kymab (or its Affiliates or Sublicensees) under or in connection with this Agreement, whether or not patented or patentable, and any and all Patents and other intellectual property rights with respect thereto. |
6.4 |
Assignment Obligation. Kymab shall cause all Persons who perform Development activities for Kymab under this Agreement to be under an obligation to assign (or, if Kymab is unable to cause such Person to agree to such assignment obligation despite Kymabs using commercially reasonable efforts to negotiate such assignment obligation, provide a license under) their rights in any Information and inventions resulting therefrom to Kymab, except where Applicable Law requires otherwise and except in the case of governmental, not-for-profit and public institutions which have standard policies against such an assignment (in which case a suitable license, or right to obtain such a license, shall be obtained). |
14
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
6.5 |
F-star Patent Prosecution and Maintenance. F-star shall have the right, but not the obligation, at its cost, through the use of internal or outside counsel of its choosing to prepare, file, prosecute, and maintain any claims of any F-star Patents [***]. |
6.6 |
Kymab Patent Prosecution and Maintenance. Kymab shall have the right, but not the obligation, through the use of internal or outside counsel of its choosing to prepare, file, prosecute, and maintain any claims of any Patents that cover or claim the Kymab mAb2; provided that[***]. Notwithstanding the foregoing, if Kymab wishes to file, prosecute or claim any Patent which includes [***], then Kymab shall provide F-star with[***] written notice of such intention including full details of the proposed disclosure of such [***], so that F-star may itself take steps to file a Patent claiming [***] if it wishes to do so. If F-star wishes to file such a Patent then the Parties shall [***]. |
6.7 |
Cooperation. F-star agrees, at Kymabs request to provide reasonable cooperation in the preparation, filing, prosecution, and maintenance of the Patents claiming the Kymab mAb2. |
6.8 |
Patent Listings. Kymab shall have no right to include a Patent of F-star in any filings with Regulatory Authorities in the Territory, including as required or allowed in the United States, in the FDAs Orange Book if in the future legislation employs the Orange Book for biologics, or its alternative, or its equivalent in any other country. |
6.9 |
Enforcement of Patents. F-star shall have the sole and exclusive right, but not the obligation, to enforce and defend worldwide under its control, at its own expense, F-star Patents. Kymab shall have the sole and exclusive right, but not the obligation, to enforce and defend worldwide under its control, at its own expense, any Patent claiming the Kymab mAb2. |
6.10 |
Cooperation. The Parties agree to cooperate fully in any action pursuant to Clause 6.9. Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Where the action concerns [***] then F-star shall have the right to be represented in such proceedings at its own cost. Unless otherwise set forth herein, the Party entitled to bring any action in accordance with this Clause 6.10 shall have the right to settle such claim; provided that no Party shall have the right to settle any action under this Clause 6.10 in a manner that diminishes or has a material adverse effect on the rights or interest of the other Party, or in a manner that imposes any costs or liability on, or involves any admission by, the other Party, without the express written consent of such other Party, such consent not to be unreasonably withheld, conditioned or delayed. The Party commencing or responding to the action shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings; provided however that the foregoing requirement shall not apply in respect of a Partys defence of opposition proceedings pursuant to Clause 6.9. |
15
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
6.11 |
Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such litigation shall be retained by the Party that has exercised its right to bring the enforcement action and any amount remaining after the reimbursement of costs incurred by or on behalf of the Party bringing such proceedings shall be treated as Net Sales for the purpose of the payment of royalties hereunder. |
6.12 |
F-star shall have the sole and exclusive right, but not the obligation, to defend and control the defence of the validity and enforceability of any F-star Patents. |
6.13 |
Inventors Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Partys inventors under any applicable inventor remuneration laws. |
7. |
CONFIDENTIALITY AND NON-DISCLOSURE |
7.1 |
Each Party agrees that it shall keep the Confidential Information received from the other Party confidential and shall not use or disclose the same without the prior written authority of the disclosing Party other than as specifically permitted pursuant to this Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Clause 7.1 with respect to any Confidential Information shall not include any information that: |
7.1.1 |
has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party; |
7.1.2 |
have been in the receiving Partys possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
7.1.3 |
is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
7.1.4 |
that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
7.1.5 |
have been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Partys Confidential Information. |
7.2 |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party. |
16
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
7.3 |
Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
7.3.1 |
in the reasonable opinion of the receiving Partys legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators, but subject to Clause 7.5)); provided, that the receiving Party shall first have given prompt written notice (and to the extent possible, at least [***] notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information. In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed; |
7.3.2 |
made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with Applicable Law; |
7.3.3 |
made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining, defending or enforcing a Patent in accordance with the terms of this Agreement; provided, (i) that the receiving Party shall first have given at least [***] written notice to the disclosing Party, and (ii) that reasonable measures shall be taken to assure confidential treatment of such Confidential Information, to the extent such protection is available; |
7.3.4 |
made to its or its Affiliates, financial and legal advisors who have a need to know such disclosing Partys Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, at least as restrictive as those set forth in this Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and legal advisors, to treat such Confidential Information as required under this Clause 7; |
7.3.5 |
made by the receiving Party or its Affiliates to potential or actual investors, acquirers, investment bankers, lenders, as may be necessary in connection with their evaluation of a potential or actual investment in or acquisition of the receiving Party or its Affiliates; provided, that such Persons shall be subject to |
17
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Clause 7; |
7.3.6 |
made by Kymab or its Affiliates or Sublicensees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in connection with the development or Commercialisation of the Kymab mAb2, and Kymab Licensed Product, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this clause 7 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors); or |
7.3.7 |
made by F-star or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of Kymab substantially similar to the obligations of confidentiality and non-use of F-star pursuant to this clause 7 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors and the like). |
7.4 |
Use of Name. Except as expressly provided herein, neither of F-star nor its Affiliates, shall mention or otherwise use the name, logo, or trademark of Kymab or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of Kymab in each instance. Except as expressly provided herein, neither Kymab nor any of its Affiliates shall mention or otherwise use the name, logo, or Trademark of F-star or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of F-star. The restrictions imposed by this Clause 7.4 shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Partys counsel, is required by Applicable Law; provided, that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. |
7.5 |
Public Announcements. Neither F-star and its Affiliates, on the one hand, and Kymab and its Affiliates on the other, shall issue any public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the |
18
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
others prior written consent, except for any such disclosure that is, in the opinion of the disclosing entitys counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing entity are listed (or to which an application for listing has been submitted); save that [***]. In the event an entity is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such entity shall submit the proposed disclosure in writing to Kymab (if the entity making the disclosure is F-star) or F-star (if the entity making the disclosure is Kymab) as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. |
7.6 |
Publications. Each Party acknowledges that its scientific publications and presentations must be strictly monitored to prevent any adverse effect from premature publication of results of the development activities hereunder. |
7.7 |
Kymab shall have the right to make any publications, presentations or public disclosures related to the Kymab mAb2. Before any paper, abstract, poster, presentation or other publication or public disclosure (Publication) is submitted for publication, Kymab shall deliver a then-current copy of the Publication to F-star at least [***] prior to any disclosure, release or submission of such Publication. F-star shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to Kymab with appropriate comments, if any. Notwithstanding the foregoing, F-star shall have the right within such [***] to delay the disclosure, release, or submission of the Publication for up to [***] in order (i) to require the deletion of any Confidential Information belonging to F-star that may be disclosed by the Publication; and (ii) to permit adequate steps to be taken to secure patent or other protection for anything referred to in the Publication. Kymab shall comply with F-stars request to delete references to F-stars Confidential Information in any such paper and will withhold publication of any such paper or any presentation of same for up to [***] in order to permit the Parties to obtain Patent protection if F-star deems it necessary. If Kymab receives no comments or requests to delay the Publication within the[***] period following its delivery to F-star, F-star shall be deemed to approve the original version of the Publication sent to it by Kymab. |
7.8 |
Notwithstanding anything herein to the contrary, F-star and its Affiliates shall have the right to make any publications, presentations or public disclosures relating to (i) any Fcabs other than the F-star Human PD-L1 Fcab and (ii) the F-star Human PD-L1 Fcab other than to the extent related to the Kymab mAb2 or Kymab Licensed Product. |
7.9 |
Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first Party does not retain rights under the surviving provisions of this Agreement: (a) as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) as soon as reasonably practicable, deliver to the requesting Party, at the other Partys expense, all copies of such Confidential Information in the possession of the other Party; provided, that the other Party shall be permitted to retain one (1) copy of such |
19
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Confidential Information for the sole purpose of performing any continuing obligations hereunder, as required by Applicable Law, or for archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Partys automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Partys standard archiving and back-up procedures, but not for any other use or purpose. |
7.10 |
Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for [***] after the expiry or earlier termination of this Agreement. |
8. |
WARRANTIES AND COVENANT |
8.1 |
Each Party warrants, as of the Effective Date as follows: |
8.1.1 |
Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
8.1.2 |
Authorization. The execution and delivery of this Agreement and the performance by that Party of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) that Partys charter documents, bylaws, or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which such Party is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to that Party. |
8.1.3 |
Binding Agreement. This Agreement is a legal, valid, and binding obligation of that Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). |
8.1.4 |
No Inconsistent Obligation. That Party is not under any obligation and shall not during the term of this Agreement agree to be subject to any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfilment of its obligations hereunder. |
8.1.5 |
There are no written claims or allegations, judgments or settlements against, or amounts with respect thereto owed by F-star or any of their respective Affiliates relating to a claim that any activities or products covered by F-star Patents infringe the intellectual property rights of any Third Party. |
8.2 |
F-star warrants that at the Effective Date F-star has Control of all Patents, Know How and Data licensed to Kymab hereunder and after the Effective Date none of F-star or its Affiliates shall enter into any agreement that conflicts with or restricts the rights granted to Kymab under this Agreement. |
20
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
8.3 |
F-star Ltd warrants that after the Effective Date none of F-star Ltd or its Affiliates (including for the avoidance of doubt, F-star GmbH) shall enter into any agreement that conflicts with or restricts the rights granted to Kymab under this Agreement. |
8.4 |
Non-Debarment. Kymab hereby undertakes to F-star that it will not use in any capacity, in connection with the manufacture, use, import, development or sale of the Licensed Products during the Term of this Agreement, any individual or entity who has been debarred by the relevant health authorities. |
8.5 |
DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NONE OF F-STAR, OR KYMAB OR ANY OF THEIR RESPECTIVE AFFILIATES MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. |
9. |
INDEMNITY |
9.1 |
No Consequential Damages. Subject to Clause 9.6, but otherwise notwithstanding any other provision of this Agreement, neither Party shall be liable to the other Party or to any Affiliate of the other Party for any lost profits, business opportunities, special, indirect, consequential, exemplary, or punitive damages of any nature arising under or in relation to this Agreement even if that Party was advised in advance of the possibility of such loss or damage. |
9.2 |
Indemnification by Kymab. Kymab shall, subject to Clauses 9.1 and 9.6, indemnify, F-star, its Affiliates, and its and their respective directors, officers, employees and agents (collectively the F-star Indemnified Parties) against any and all claims, causes of action, demands, liabilities, losses, damages, costs or expenses, including reasonable attorneys fees, in each case asserted by a Third Party (each a Loss and collectively Losses) incurred or suffered by the F-star Indemnified Parties to the extent such Loss arose out of or was caused by the development, manufacture, use, distribution, marketing, promotion or sale of any Kymab mAb2 or Kymab Licensed Product by or on behalf of Kymab or its Affiliates or sublicensees in the Territory; except, in all cases, to the extent that such Loss arises out of the negligence or wilful misconduct of F-star. |
9.3 |
Notification of Liabilities/Losses. A person or entity entitled to indemnification under this Clause 9 (an Indemnified Party) shall give prompt written notification (within [***]) to Kymab of the commencement or notice of Loss for which indemnification may be sought or, if earlier, upon the assertion of any such Loss (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Loss |
21
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
as provided in this Clause 9.3 shall not relieve Kymab of its indemnification obligation under this Agreement except, and only, to the extent that Kymab is materially prejudiced as a result of such failure to give notice). Kymab shall be liable for any reasonable legal fees and expenses subsequently incurred in connection with the defence of such Loss after receiving such notice. F-star shall thereafter keep Kymab informed of any Losses. |
9.4 |
In the case of a Loss for which F-star seeks indemnification under Clause 9.2, F-star shall permit Kymab to direct and control the defence of the Loss and shall provide such reasonable assistance as is reasonably requested by Kymab (at Kymabs cost) in the defence of the Loss; provided that nothing in this Clause 9.4 shall permit Kymab to make any admission on behalf of F-star, or to settle any claim or litigation which would impose any financial obligations on F-star or would result in any loss or diminution of the scope, validity or enforceability of the F-star intellectual property without the prior written consent of F-star, such consent not to be unreasonably withheld or delayed. |
9.5 |
Mitigation. Where F-star makes a claim under this Clause 9, F-star shall take all reasonable steps to mitigate and/or minimise the Losses suffered and shall not do anything nor fail to do something which would have the effect of increasing the Losses. |
9.6 |
Restriction on Limitation of Liability. Neither Party limits or excludes its liability for fraud or fraudulent misrepresentation, nor for death or personal injury arising from its negligence. |
9.7 |
Insurance. Kymab shall procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Licensed Product is being clinically tested with human subjects or commercially distributed or sold. It is understood that such insurance shall not be construed to create a limit of Kymabs liability with respect to its indemnification obligations under this Clause 9. |
10. |
TERM AND TERMINATION |
10.1 |
This Agreement shall commence on the Effective Date and shall continue in force and effect unless earlier terminated in accordance herewith (the Term). |
10.2 |
Kymab shall have the right by[***] written notice to F-star to terminate its rights and obligations in relation to the Kymab mAb2 or Kymab Licensed Products. On any termination by Kymab of its rights and obligations pursuant to this Clause 10.2 save as provided for in Clause 10.8, Kymab shall have no obligations or liability to F-star in respect of the Kymab mAb2 or Licensed Product. |
10.3 |
Termination for Breach. F-star shall have the right to terminate this Agreement insofar as it relates to the licences and rights granted by F-star in the event that Kymab commits a material breach of this Agreement. F-star shall first provide written notice to Kymab which notice shall clearly describe the nature of the breach. Kymab shall have[***] in which to cure the breach (or such longer period as is set out in the notice). If Kymab fails to cure the breach within [***] (or such longer period as is set out in the notice) then F-star may terminate this Agreement insofar as it relates to the licences and rights granted by F-star immediately on written notice. |
22
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
10.4 |
F-star will have the right to terminate this Agreement in respect of Kymabs rights upon written notice to Kymab in the event that (i) Kymab or any of its Affiliates directly asserts or directs or assists a Third Party to challenge in any court or patent office the validity or enforceability of any F-star Patent and (ii) Kymab does not cease such activity within[***] of such notice from F-star. |
10.5 |
Kymab will have the right to terminate this Agreement in respect of F-stares rights upon written notice to F-star in the event that (i) F-star or any of its Affiliates directly asserts or directs or assists a Third Party to challenge in any court or patent office the validity or enforceability of any mAb2 Patent controlled by Kymab and (ii) F-star does not cease such activity within [***] of such notice from Kymab. |
10.6 |
Effects of Termination. The rights and obligations under this Agreement shall immediately terminate with respect to the Kymab mAb2 or Licensed Products for which this Agreement has been terminated. The obligations under this Agreement shall continue for the Kymab mAb2 or Licensed Products for which this Agreement has not been terminated. In the event that Kymab terminates its rights under this Agreement pursuant to Clause 10.2 then the provisions of Clause 3.5.2 shall expire and F-star shall no longer be subject to the restrictions therein. In the event that F-star terminates Kymabs rights under this Agreement pursuant to Clause 10.3 or Clause 10.4 then the provisions of clauses 3.5.2 shall expire and F-star shall no longer be subject to the restrictions therein. |
10.7 |
Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
10.8 |
Termination or expiration of this Agreement as a whole or with respect to the Kymab mAb2 and Licensed Products for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, Clauses 5.9, 5.10, 5.11, 5.12, 3.5.2 (unless the same have been deemed to expire pursuant to clause 10.6), 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 7, 8.5, 9, 10.6, 10.7, 10.8 and 11 shall survive the termination or expiration of this Agreement for any reason. |
11. |
MISCELLANEOUS |
11.1 |
Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts, or other labour disturbances |
23
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within [***] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. |
11.2 |
Assignment. Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed no Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided, that a Party may make such an assignment without the other Partys consent to (a) its Affiliate, or (b) in the case of F-star, to F-star Ltd or F-star GmbH or to their respective Affiliates, or (c) to a successor, whether in a merger, sale of stock, sale of assets or any other transaction, of the business to which this Agreement relates. With respect to an assignment to an Affiliate, or in the case of F-star, to F-star Ltd or F-star GmbH or to their respective Affiliates, the assigning Party shall remain responsible for the performance by such Affiliate of the rights and obligations hereunder. Any attempted assignment or delegation in violation of this Clause 11.2 shall be void and of no effect. All validly assigned and delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of F-star or Kymab, as the case may be. The permitted assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement. Without limiting the foregoing, the grant of rights set forth in this Agreement shall be binding upon any successor or permitted assignee of F-star, F-star GmbH or F-star Ltd, and the obligations of Kymab, including the payment obligations, shall run in favour of any such successor or permitted assignee of F-stars benefits under this Agreement. |
11.3 |
Notwithstanding anything to the contrary herein, no Know-How, Patents or other intellectual property rights not Controlled by F-star or Kymab or any of their respective Affiliates before a Change in Control of such Person will be Controlled by such Person for purposes of this Agreement after such Change in Control. |
11.4 |
Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect. |
24
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
11.5 |
Governing Law, Jurisdiction and Service. |
11.5.1 |
Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England. |
11.5.2 |
Dispute Resolution. If a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute), it shall be resolved pursuant to this Clause 11.5. |
11.5.3 |
General. Any Dispute shall first be referred to the Chief Executive Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Chief Executive Officers shall be conclusive and binding on the Parties. If the Chief Executive Officers are not able to agree on the resolution of any such issue within [***] (or such other period of time as mutually agreed by the Chief Executive Officers) after such issue was first referred to them either Party may commence proceedings in the English courts |
11.6 |
Notices. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, or (b) sent by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified below or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Clause 11.6. Such notice shall be deemed to have been given (i) as of the date of delivery if delivered on a Business Day (at the place of delivery or the next Business Day if the date of delivery is not a Business Day) by hand; and (ii) on the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Clause 11.6 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. |
Address for Notice.
If to Kymab, to:
Kymab Limited.
The Bennet Building (B930),
Babraham Research Campus,
Cambridge,
United Kingdom, CB22 3AT
25
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Attention: Chief Executive Officer
Facsimile:
and
If to F-star:
F-star Beta Ltd.
Eddeva B920
Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Legal Department
11.7 |
Entire Agreement; Amendments. Save in respect of the confidentiality agreement entered into by the Parties on 28 May 2015 and the Material Transfer Agreement, this Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. |
11.8 |
English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. |
11.9 |
Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein. |
11.10 |
Third Parties. With the exception of a Sublicensee pursuant to Clause 3.3, a person who is not a party to this agreement shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this agreement, but this does not affect any right or remedy of a third party which exists, or is available, apart from under that Act. |
11.11 |
Further Assurance. Each party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other party may reasonably |
26
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other party its rights and remedies under this Agreement. |
11.12 |
Relationship of the Parties. It is expressly agreed that F-star, on the one hand, and Kymab, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for tax purposes. Neither F-star, on the one hand, nor Kymab, on the other hand, shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party. |
11.13 |
Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by facsimile or electronically transmitted signatures and such signatures shall be deemed to bind each party hereto as if they were original signatures. |
[SIGNATURE PAGES FOLLOW.]
27
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
THIS AGREEMENT IS EXECUTED as of the Effective Date by the authorized representatives of the Parties:
KYMAB LIMITED. | ||
By: |
/s/ David Chiswell |
|
Name: | David Chiswell | |
Title: | Board Advisor | |
F-STAR BETA LIMITED | ||
By: |
/s/ Tolga Hassan |
|
Name: | Tolga Hassan | |
Title: | CFO |
and by the authorized representative of F-star Biotechnology Limited solely for the purposes of clauses 3.5.1, 3.5.2, 4.4 and 8.3.
F-STAR BIOTECHNOLOGY LIMITED | ||
By: |
/s/ Tolga Hassan |
|
Name: | Tolga Hassan | |
Title: | CFO |
28
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
SCHEDULE 1
PART A
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
29
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
PART B
[***]
|
[***] |
|
[***] |
1) |
[***] |
2) |
[***] |
3) |
[***] |
4) |
[***] |
30
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
SCHEDULE 2
[***]
[***]
[***]
[***]
[***]
[***]
[***]
31
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
SCHEDULE 3
Appointment of Expert
If either Party wishes to appoint an independent expert (the Expert) to determine any matter pursuant to any Clause of this Agreement, the following procedures will apply:
1. |
The Party wishing to appoint the Expert (the Appointing Party) will serve a written notice on the other Party (the Responding Party). The written notice will specify the Clause pursuant to which the appointment is to be made and will contain reasonable details of the matter(s) which the Appointing Party wishes to refer to the Expert for determination |
2. |
The Parties shall within [***] following the date of the Appointing Partys written notice use all reasonable efforts to agree who is to be appointed as the Expert to determine the relevant matter(s). If the Parties are unable to agree upon the identity of the Expert within that timescale, the Expert shall be appointed by [***] upon written request of either Party. |
3. |
Each Party will within [***] following appointment of the Expert, prepare and submit to the Expert and the other Party a detailed written statement setting out its position on the matter(s) in question and including any proposals which it may wish to make for settlement or resolution of the relevant matter. |
4. |
Each Party will have [***] following receipt of the other Partys written statement to respond in writing thereto. Any such response will be submitted to the other Party and the Expert. |
5. |
The Expert will if he/she deems appropriate be entitled to seek clarification from the Parties as to any of the statements or proposals made by either Party in their written statement or responses. Each Party will on request make available all information in its possession and shall give such assistance to the Expert as may be reasonably necessary to permit the Expert to make his/ her determination. |
6. |
The Expert will issue his/her decision on the matter(s) referred to him/ her in writing as soon as reasonably possible, but at latest within [***] following the date of his/ her appointment. The Experts decision shall (except in the case of manifest error) be final and binding on the Parties. |
7. |
The Expert will at all times act as an independent and impartial expert and not as an arbitrator. |
8. |
The Experts charges will be borne [***]. |
32
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Exhibit 10.35
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
AMENDED AND RESTATED
PD-L1 LICENCE AGREEMENT
between
F-STAR BETA LIMITED
and
KYMAB LIMITED
Dated as of 26th day of November 2018
CONFIDENTIAL
Index
Clause No. | Page No. | |||||
1. |
DEFINITIONS |
1 | ||||
2. |
SEQUENCES and ALLIANCE MANAGER |
8 | ||||
3. |
LICENCES |
9 | ||||
4. |
DILIGENCE |
10 | ||||
5. |
PAYMENTS AND RECORDS |
10 | ||||
6. |
INTELLECTUAL PROPERTY |
13 | ||||
7. |
CONFIDENTIALITY AND NON-DISCLOSURE |
15 | ||||
8. |
WARRANTIES AND COVENANT |
19 | ||||
9. |
INDEMNITY |
20 | ||||
10. |
TERM AND TERMINATION |
22 | ||||
11. |
MISCELLANEOUS |
23 | ||||
SCHEDULE 1 |
28 | |||||
SCHEDULE 2 |
30 | |||||
SCHEDULE 3 |
31 | |||||
SCHEDULE 4 |
32 |
This Agreement is made on 26th day of November 2018 (the Amendment Date) by and between:
(1) |
F-STAR BETA LIMITED, an English limited company (company number 09263520) with its registered office at Eddeva B920, Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT (F-star); and |
(2) |
KYMAB LIMITED, an English limited company (company number 07027523) with its registered office at The Bennet Building (B930), Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT (Kymab). |
F-star and Kymab are sometimes referred to herein individually as a Party and collectively as the Parties.
RECITALS
(A) |
Kymab Controls certain intellectual property rights with respect to various monoclonal antibodies directed at the PD-L1 target and F-star has selected one such antibody to be provided by Kymab to F-star; |
(B) |
Kymab, pursuant to an agreement between Kymab and F-star Beta dated 19 April 2016, (the Original Agreement) has granted a limited licence to F-star Beta under its intellectual property rights in the PD-L1 monoclonal antibody selected by F-star Beta. The Original Agreement was amended by Kymab and F-star Beta by a letter dated 17 May 2017; |
(C) |
The Parties have agreed to amend and restate the Original Agreement insofar as it relates to the grant of the limited licence by Kymab to F-star under its intellectual property rights in the PD-L1 monoclonal antibody selected by F-star as further set out in this Agreement. |
NOW THEREFORE, in consideration of the following mutual promises and obligations, and for other good and valuable consideration the adequacy and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1. |
DEFINITIONS |
In this Agreement and in the Schedules to this Agreement the following capitalised terms, whether used in the singular or plural, shall have the meanings set forth below:
1.1 |
Affiliate means, with respect to a given entity, any person, corporation, or other entity, that Controls, is Controlled by, or is under common Control with such entity where for the purposes of this definition Control shall mean in respect of any corporation or other entity, the direct or indirect ownership of more than fifty percent (50%) of the outstanding shares or other voting rights of the subject entity having the power to vote on or direct the affairs of the entity, (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction). Any other relationship which in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute Control. For the avoidance of doubt, F-star Alpha, F-star Gamma, F-star Delta, F-star GmbH and F-star Ltd shall not be considered to be Affiliates of F-star. |
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.2 |
Agreement means this agreement and all schedules, appendices and other addenda attached hereto as any of the foregoing may be amended in accordance with the provisions of this Agreement. |
1.3 |
Applicable Law means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder. |
1.4 |
Business Day means a day other than a Saturday or Sunday on which banking institutions in London, England are open for business. |
1.5 |
Calendar Quarter means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. |
1.6 |
Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. |
1.7 |
Combination Product means a Licensed Product containing or consisting of one (1) or more F-star mAb2 together with one (1) or more Other Active Ingredients, whether in the same or different formulations. |
1.8 |
Commercialisation means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a molecule or product, including activities related to marketing, promoting, distributing, importing and exporting such molecule or product, and, for purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting Phase IV Studies, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, to Commercialise and Commercialising means to engage in Commercialisation, and Commercialised has a corresponding meaning. |
1.9 |
Commercially Reasonable Efforts means, with respect to the performance of a Partys activities under this Agreement, the carrying out of such activities using efforts and resources comparable to the efforts and resources that [***] would typically devote to compounds or products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial, and other factors that the company would take into account, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability (including royalties and other payments required hereunder), expected and actual competitiveness of alternative products (including generic or biosimilar products) in the marketplace, the nature and extent of expected and actual market |
- 2
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
exclusivity (including patent coverage and regulatory exclusivity), the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required. |
1.10 |
Confidential Information means any Information or data provided orally, visually, in writing or other form by or on behalf of one Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement before, on, or after the Effective Date, including Information relating to the disclosing Partys products, technology, research plans, business affairs and/or finances, the terms of this Agreement or any Licensed Product. |
1.11 |
Control means, with respect to any item of Information, Regulatory Documentation, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of the license and other grants in Clause 3.1), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party[***]. |
1.12 |
Data means the Kymab PD-L1 Antibody Data. |
1.13 |
Effective Date means 19 April 2016. |
1.14 |
F-star Alpha means F-star Alpha Limited, an English limited company whose company number is 08676690 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT. |
1.15 |
F-star Delta means F-star Delta Limited, an English limited company whose company number is 10543154 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT; |
1.16 |
F-star Gamma means F-star Gamma Limited, an English limited company whose company number is 10214672 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT. |
1.17 |
F-star GmbH means F-star Biotechnologische Forschungs- Und Entwicklungsges.M.B. H, an Austrian company whose registered office is Schwarzenbergplatz 7, A-1030 Vienna, Austria. |
1.18 |
F-star Ltd means F-star Biotechnology Limited, an English limited company whose company number is 08067987 and whose registered office is at Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT. |
1.19 |
F-star Licensed Product means any product which contains the F-star mAb2. |
- 3
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.20 |
F-star mAb2 means a product comprising an antibody (a) in which the CH3 domain contains the antigen binding loops of a LAG3 Fcab and (b) which contains the variable region of the Kymab PD-L1 Antibody. |
1.21 |
Fab means the region on an antibody that binds to antigens which is composed of one (1) constant and one (1) variable domain of each of the heavy and the light chain. |
1.22 |
Fcab means an Fc fragment of an antibody that harbours an antigen binding site that confers a specific binding of such Fc fragment to a defined target antigen, which Fc fragment is generated by or on behalf of F-star. |
1.23 |
Fcab Licence means the agreement entered into between F-star and Kymab dated on the Effective Date pursuant to which F-star has granted a licence to Kymab to use an F-star PD-L1 Fcab (as defined in said agreement) in products containing a mAb2 comprising the F-star PD-L1 Fcab and an ICOS Fab component. |
1.24 |
Field means all therapeutic, prophylactic and diagnostic uses, including the treatment of human and animal disease. |
1.25 |
First Commercial Sale means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after Regulatory Approval for such Licensed Product has been obtained in such country. [***]. |
1.26 |
Information means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed. |
1.27 |
Know-How means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions. |
1.28 |
Kymab Background Patents means any and all Kymab Patents which do not specifically claim the Kymab PD-L1 Antibody or a sequence of the variable region and/or antigen binding loops in the variable region of the Kymab PD-L1 Antibody. |
- 4
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.29 |
Kymab Know-How means any Kymab Know-How in relation to the Kymab PD-L1 Fab that (i) is in Kymabs Control on or prior to the Effective Date and/or (ii) is assigned to Kymab pursuant to Clause 6.2. |
1.30 |
Kymab Patents means any and all Patents Controlled by Kymab on the Effective Date or during the Term that have claims that would, in the absence of a licence, be infringed by the research, development or Commercialisation of an F-star mAb2. Kymab Patents specifically includes the claims of any Patent that covers a Kymab PD-L1 Antibody that is Controlled by Kymab, except for any Patent filed by F-star in respect of the F-star mAb2 pursuant to Clause 6.5. |
1.31 |
Kymab PD-L1 Antibody means the PD-L1 Antibody specifically identified in Schedule 1, Part A. |
1.32 |
Kymab PD-L1 Antibody Data means the data that is in Kymabs Control on or prior to the Effective Date, including that described in Schedule 1, Part B, in respect of the Kymab PD-L1 Antibody. |
1.33 |
Kymab PD-L1 Fab means the Fab portion of the Kymab PD-L1 Antibody. |
1.34 |
LAG3 means Lymphocyte activation gene 3 (registered with Uniprot number P18627), also known as Protein FDC or CD223. |
1.35 |
Licensed Product means an F-star Licensed Product alone, or as part of a Combination Product, in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes, including any improvements thereto. |
1.36 |
Losses has the meaning set forth in Clause 9.2. |
1.37 |
mAb2 Patents means any Patents filed by F-star or F-star Delta that claim the composition of matter of an F-star mAb2. |
1.38 |
Material Transfer Agreement means the material transfer agreement between F-star Ltd and Kymab dated 28 May 2015. |
1.39 |
Mono Product has the meaning set forth in the definition of Net Sales in Clause 1.41. |
1.40 |
Net Receipts means any payment (including any option fee, upfront payment, milestone, royalty or other consideration) received by F-star from a Third Party in consideration for an option for rights, or the grant of rights, in respect of an F-star Licensed Product which is received by F-star, whether before or after the date of this Agreement, less any value added or other taxes that are withheld from or which F-star is liable to pay in relation to such receipt. |
1.41 |
Net Sales means, [***] |
(a) |
[***] |
(b) |
[***] |
(c) |
[***] |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(d) |
[***] |
(e) |
[***] |
[***]
[***]
[***]
[***]
(i) |
[***] |
(ii) |
[***] |
(iii) |
[***] |
(iv) |
[***] |
1.42 |
Other Active Ingredient means an active pharmaceutical ingredient which has a therapeutic effect which is independent of the relevant F-star mAb2. Drug delivery vehicles, adjuvants and excipients shall not be deemed to be active pharmaceutical ingredients and their presence shall not be deemed to create a Combination Product. For the avoidance of doubt, the Other Active Ingredient and the relevant F-star mAb2 must be separate and distinct components of the Combination Product, and the presence of an antibody fragment or region within a trispecific F-star mAb2 shall not be deemed to create a Combination Product. |
1.43 |
Patents means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b), and (c)), and (e) any similar patent rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents. |
1.44 |
PD-L1 means Programmed Death-Ligand 1 (registered with Uniprot number Q9NZQ7), also known as B7-H1 or CD274. |
1.45 |
PD-L1 Antibody means any monoclonal antibody directed to human PD-L1. |
1.46 |
Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. |
1.47 |
Phase 3 Clinical Trial means a clinical trial which is designed to (a) establish that the relevant product is safe and efficacious for its intended use: (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed and (c) support Regulatory Approvals. |
1.48 |
PoC Trial means the first phase 2 clinical trial that is reasonably designed to provide initial evidence of efficacy of the relevant product and it is not intended to be a pivotal clinical trial or a dose ranging study. |
1.49 |
Regulatory Approval means, with respect to a country or other jurisdiction in the Territory, any and all approvals, licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialise a F-star mAb2 or Licensed Product in such country or other jurisdiction, including, where applicable pricing or reimbursement approval in such country or other jurisdiction. |
1.50 |
Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Commercialisation of any F-star mAb2 or Licensed Products in the Territory. |
1.51 |
Relevant Currency means (i) in relation to clause 5.1: the currency in which the Net Receipts are received by F-star (ii) in relation to clause 5.2: Pounds Sterling and (iii) in relation to clauses 5.3, 5.4 and 5.10: in Pounds Sterling or, in the event that a Third Party acquires a majority of the shares in F-star, the currency in which that Third Party reports its annual audited accounts. |
1.52 |
Royalty Term means with respect to each F-star Licensed Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country, and ending on the first to occur of (a) the last to occur of the expiration, invalidation or abandonment of the last Kymab Patent or mAb2 Patent as the case may be that includes a Valid Claim that covers the manufacture, sale, or use of the F-star Licensed Product or the F-star mAb2 in such country, and (b) the date that is ten (10) years from the date of the First Commercial Sale of such Licensed Product anywhere in the world. |
1.53 |
Sublicensee means a Third Party, other than a distributor, that is granted a sublicense by F-star under the grants in Clause 3.1 as provided in Clause 3.2. |
1.54 |
Term has the meaning set forth in Clause 10.1. |
1.55 |
Territory means all countries and territories worldwide. |
1.56 |
Third Party means any Person other than F-star, Kymab and their respective Affiliates. For the avoidance of doubt, F-star Alpha,F-star Gamma, F-star Delta, F-star GmbH and F-star Ltd shall be deemed to be Third Parties. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.57 |
Valid Claim means a claim of any issued and unexpired Patent directed to patentable subject matter for which the validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal. |
1.58 |
This Agreement shall be interpreted and construed pursuant to the following rules of interpretation and construction: |
1.58.1 |
all references to a particular clause or schedule shall be a reference to that clause or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement; |
1.58.2 |
in the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control; |
1.58.3 |
the headings are inserted for convenience only and shall be ignored in construing this Agreement; |
1.58.4 |
words importing the masculine gender shall include the feminine; |
1.58.5 |
words denoting persons shall include any individual, partnership, company, corporation, joint venture, trust association, organisation or other entity, in each case whether or not having separate legal personality; |
1.58.6 |
the words include, included, including and in particular or any similar expression are to be construed as illustrative and without limitation to the generality of the preceding words; and |
1.58.7 |
reference to any statute or regulation includes any modification or re-enactment of that statute or regulation. |
2. |
SEQUENCES and ALLIANCE MANAGER |
2.1 |
The sequence of the Kymab PD-L1 Antibody is recorded in Schedule 1 Part A. Within[***] of the Effective Date, Kymab shall disclose the Kymab PD-L1 Antibody Data to F-star. In the event that Kymab becomes aware that any of the Kymab PD-L1 Antibody Data disclosed by it to F-star may negatively affect F-stars research or development activities pursuant to the licence granted under clause 3.1, Kymab shall, to the extent that it is reasonably able to do so, promptly notify F-star. |
2.2 |
Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an Alliance Manager). Each Party may replace its Alliance Manager at any time by notice in writing to the other Party. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
3. |
LICENCES |
3.1 |
Kymab hereby grants to F-star: |
3.1.1 |
an exclusive licence under the Kymab Patents (other than the Kymab Background Patents) and the Kymab PD-L1 Antibody Data (in the case of the Data being that existing at the Effective Date); and |
3.1.2 |
a non exclusive licence under the Kymab Know-How and the Kymab Background Patents; |
in each case with the right to grant sublicences (subject to Clause 3.2), to the extent necessary or desirable solely for the purpose of researching, developing, manufacturing, using and Commercialising F-star Licensed Products in the Field in the Territory. It is acknowledged and agreed that the rights granted pursuant to this clause 3.1 under the Kymab Know-How and the Kymab PD-L1 Antibody Data extend solely to the Kymab Know-how and Kymab PD-L1 Antibody Data that relate to, and the specific sequence of, the Kymab PD-L1 Antibody set out in Schedule 1 Part A.
3.2 |
F-star shall have the right to grant sublicences through multiple tiers of sublicences to Sublicensees; provided that any such sublicences shall (a) be in writing, (b) be not inconsistent with the terms and conditions of this Agreement, and (c) require the applicable Sublicensee to comply with all applicable terms of this Agreement. Each sublicence granted hereunder will terminate immediately upon the termination of the licence from Kymab to F-star with respect to such rights. |
3.3 |
Where this Agreement has been terminated after F-star has granted a sub-licence to a Sublicensee, Kymab shall, on the written request of the relevant Sublicensee, grant a licence to the Sublicensee on terms substantially similar to this Agreement but with the same scope as the relevant sub-licence. |
3.4 |
Notwithstanding the exclusive licences granted herein: |
3.4.1 |
Kymab retains the right for itself and its Affiliates to research, develop manufacture, use and Commercialise any PD-L1 Antibody and/or the Kymab PD-L1 Fab (including the sequences licensed in this agreement) in any product other than a F-star mAb2 or F-star Licensed Product, and to grant licences and sublicences (including through multiple tiers) to Third Parties under Kymab Patents, Kymab Know-How and the Kymab PD-L1 Antibody Data to any PD-L1 Antibody and/or the Kymab PD-L1 Fab for the purpose of researching, developing, manufacturing, using and Commercialising any product other than a F-star mAb2 or F-star Licensed Product. |
3.4.2 |
F-star, F-star Delta and F-star Ltd shall not, shall procure that their Affiliates shall not, and shall not assist or enable any other Third Party, during the Term of this Agreement, to research, develop manufacture, use or Commercialise any product comprising an antibody where the Fc fragment of the antibody harbours an antigen binding site that confers a specific binding of such Fc fragment to LAG3 and which contains the antigen binding loops of any PD-L1 Fab other than those of the Kymab PD-L1 Antibody, provided always that |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
if the Fcab Licence has expired or been terminated or if the provisions of clause 3.5.2 of the Fcab Licence have expired pursuant to clauses 4.2 or 4.3 of the Fcab Licence then F-star, F-star Delta and F-star Ltd shall not be subject to the restriction in this clause 3.4.2; |
3.4.3 |
F-star, F-star Delta and F-star Ltd shall not, shall procure that their Affiliates shall not, and shall not assist or enable any other Third Party, during the Term of this Agreement, to research, develop, manufacture, use or Commercialise any product comprising an antibody where the Fc fragment of the antibody harbours an antigen binding site that confers a specific binding of such Fc fragment to PD-L1 and which contains the antigen binding loops of a ICOS Fab , provided always that if the Fcab Licence has expired or been terminated or if the provisions of clause 3.5.2 of the Fcab Licence have expired pursuant to clauses 4.2 or 4.3 of the Fcab Licence then F-star, F-star Delta and F-star Ltd shall not be subject to the restriction set out in this clause 3.4.3. |
3.5 |
Except as expressly provided herein, Kymab grants no other right or licence, including any rights or licences to any of its intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel or otherwise. |
3.6 |
Kymab shall, if requested to do so by F-star, promptly enter into confirmatory licence agreements in the form or substantially the form reasonably requested by F-star for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as F-star considers appropriate. |
4. |
DILIGENCE |
4.1 |
F-star shall use Commercially Reasonable Efforts to develop and Commercialise an F-star Licensed Product. |
4.2 |
F-star shall have the exclusive right to prepare, obtain, and maintain any Regulatory Approvals and applications therefor (including the setting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities, for a F-star mAb2 or Licensed Products in the Territory (which shall include filings of or with respect to INDs or CTAs and other filings or communications with the Regulatory Authorities). |
5. |
PAYMENTS AND RECORDS |
5.1 |
Subject to Clause 5.2, F-star shall pay to Kymab the percentage of its Net Receipts set out in the table below from a Sublicensee of a F-star Licensed Product: |
Point at which the sub-licence is granted |
Proportion of Net Revenues payable | |
[***] |
[***] | |
[***] |
[***] | |
[***] |
[***] |
5.2 |
If: |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.2.1 |
the entire issued share capital of F-star is acquired by a Third Party (a) prior to the grant by F-star of a sub-licence to a Sublicensee pursuant to clause 3.2; or (b) after the grant of such a sub-licence where the acquirer of the entire issued share capital of F-star is the Sublicensee under the relevant sub-licence, F-star shall make the following payments to Kymab in place of the payments provided for in Clause 5.1: |
(i) |
[***] |
(ii) |
[***] |
(iii) |
[***] |
(iv) |
[***] |
(v) |
[***] |
(vi) |
[***] |
(vii) |
[***] |
[***]
5.3 |
In the event that either F-star sells F-star Licensed Products or in the circumstances set out in Clause 5.2.1, then commencing upon the First Commercial Sale of a Licensed Product in the Territory and for the Royalty Term, on a Licensed Product-by-Licensed Product basis, F-star shall pay to Kymab [***] of Net Sales of each F-star Licensed Product in the Territory. F-star shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country or other jurisdiction after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. |
5.4 |
In the event that F-star grants a sub-licence of rights in relation to its Licensed Product in the same or a related agreement or arrangement to the grant of any other rights, F-star shall promptly notify Kymab of such grant and it is acknowledged and agreed that the amounts apportioned to the grant of rights in relation to its Licensed Product shall fairly reflect the proportionate value of such Licensed Product. In the event of disagreement between the Parties as to the apportionment either Party may refer the determination of the fair apportionment to an independent expert in accordance with the procedure set out in Schedule 4. |
5.5 |
Royalty Payments and Reports. F-star shall calculate all amounts payable to Kymab pursuant to this Clause 5 at the end of each Calendar Quarter, which amounts shall be converted to the Relevant Currency, in accordance with Clause 5.6. F-star shall pay to Kymab the royalty amounts due with respect to a given Calendar Quarter within [***] after the end of such Calendar Quarter. Each payment of royalties shall be accompanied by a statement of the amount of Net Sales of each Licensed Product in each country or other jurisdiction in the Territory during the applicable Calendar Quarter (including such amounts expressed in local currency and as converted to the Relevant Currency), the applicable royalty rate(s) under this Agreement and a calculation of the amount of royalty payment due on such Net Sales for such Calendar Quarter. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.6 |
Mode of Payment. All payments to Kymab under this Agreement shall be made by deposit of the Relevant Currency in the requisite amount to such bank account as Kymab may from time to time designate by notice to F-star. For the purpose of calculating any sums due under this Agreement (including the calculation of Net Sales expressed in currencies other than the Relevant Currency), F-star shall convert any amount expressed in a foreign currency into the Relevant Currency equivalents using its, its Affiliates or Sublicensees standard conversion methodology consistent with recognised accounting standards (either International Financial Reporting Standards or US GAAP). |
5.7 |
Withholding Taxes. Where any sum due to be paid to Kymab hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, F-star shall remit such withholding or similar tax to the appropriate government authority, deduct the amount paid from the amount due to payee and secure and send to Kymab the best available evidence of the payment of such withholding or similar tax. If withholding or similar taxes are paid to a government authority, each Party will provide the other such assistance as is reasonably required to obtain a refund of the withheld or similar taxes, or obtain a credit with respect to such taxes paid. |
5.8 |
Indirect Taxes. All payments in this Agreement are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the Indirect Taxes). If any Indirect Taxes are chargeable in respect of any payments, F-star shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by Kymab in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by F-star are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by Kymab to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to Kymab will be transferred to F-star within [***] of receipt. |
5.9 |
Financial Records. F-star shall, and shall cause its Affiliates and Sublicensees to, keep complete and accurate books and records, including agreements, pertaining to Net Receipts and Net Sales of Licensed Products in sufficient detail to calculate all amounts payable hereunder and to verify compliance with its obligations under this Agreement. Such books and records shall be retained by F-star and its Affiliates and Sublicensees until [***] after the end of the period to which such books and records pertain. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.10 |
Audit. At the request of Kymab, F-star shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognised standing designated by Kymab and reasonably acceptable to F-star, at reasonable times during normal business hours and upon reasonable notice, to audit the books and records maintained pursuant to Clause 5.9 to ensure the accuracy of all reports and payments made hereunder. Such examinations may not (a) be conducted for any Calendar Quarter more than[***] after the end of such Calendar Year to which such books and records pertain or (b) be conducted more than once in any [***] period (unless a previous audit during such[***] period revealed an underpayment with respect to such period). The accounting firm shall disclose to the Parties only whether the reports are correct or not, and the specific details concerning any discrepancies. No other information shall be shared with Kymab. Except as provided below, the cost of this audit shall be borne by Kymab, unless the audit reveals a variance of more than [***] from the reported amounts, in which case F-star shall bear the cost of the audit. Unless disputed pursuant to Clause 5.11 below, if such audit concludes that (i) additional amounts were owed by F-star, F-star shall pay the additional amounts as provided in Clause 5.10 or (ii) excess payments were made by F-star, Kymab shall reimburse such excess payments, in either case ((i) or (ii)), within [***]after the date on which such audit is completed by Kymab. |
5.11 |
Audit Dispute. In the event of a dispute with respect to any audit under Clause 5.10, F-star and Kymab shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute shall be submitted for resolution in accordance with the provisions of Schedule 4 to a certified public accounting firm jointly selected by each Partys certified public accountants or to such other Person as the Parties shall mutually agree (the Audit Expert). The Audit Expert shall act as an expert and not as an arbitrator. The decision of the Audit Expert shall be final and the costs of such determination as well as the initial audit shall be borne between the Parties in such manner as the Audit Expert shall determine. Not later than [***] after such decision and in accordance with such decision, F-star shall pay the additional amounts as provided in Clause 5.10, or Kymab shall reimburse the excess payments, as applicable. |
5.12 |
Confidentiality. Kymab shall treat all information subject to review under this clause 5 in accordance with the confidentiality provisions of clause 7 and the Parties shall cause the Audit Expert to enter into a reasonably acceptable confidentiality agreement with F-star obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. |
6. |
INTELLECTUAL PROPERTY |
6.1 |
As between the Parties, Kymab or an Affiliate designated by Kymab shall Control all right, title, and interest in and to any and all Kymab Patents, Kymab How-How and Kymab PD-L1 Antibody Data. |
6.2 |
As between the Parties, (i) all Information and discoveries, inventions and improvements that are conceived, discovered, developed, or otherwise made by on or behalf of a Party (or its Affiliates or Sublicensees) under or in connection with this Agreement, whether or not patented or patentable, in each case that solely and exclusively relate to the Kymab PD-L1 Antibody or to the Kymab PD-L1 Fab shall |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
be Kymab Know-How and owned by Kymab (regardless of inventorship), and (ii) any and all Patents with respect thereto shall be Kymab Patents and owned by Kymab (regardless of inventorship). Accordingly, F-star will promptly disclose to Kymab in writing, the conception, discovery, development or making of any such Kymab Know-How or Kymab Patents. F-star, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), to Kymab all its right, title and interest in and to any such Kymab Know-How or Kymab Patents. On Kymabs request, F-star will execute and record assignments and other necessary documents consistent with such ownership. |
6.3 |
Except as set forth in Clause 6.1 and 6.2 above, as between the Parties, F-star shall own and retain all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of F-star (or its Affiliates or Sublicensees) under or in connection with this Agreement, whether or not patented or patentable, and any and all Patents and other intellectual property rights with respect thereto. |
6.4 |
Assignment Obligation. F-star shall cause all Persons who perform Development activities for F-star under this Agreement to be under an obligation to assign (or, if F-star is unable to cause such Person to agree to such assignment obligation despite F-stars using commercially reasonable efforts to negotiate such assignment obligation, provide a license under) their rights in any Information and inventions resulting therefrom to F-star, except where Applicable Law requires otherwise and except in the case of governmental, not-for-profit and public institutions which have standard policies against such an assignment (in which case a suitable license, or right to obtain such a license, shall be obtained). |
6.5 |
F-star Patent Prosecution and Maintenance. F-star shall have the right, but not the obligation, through the use of internal or outside counsel of its choosing to prepare, file, prosecute, and maintain any claims of any Patents that cover or claim the F-star mAb2; provided that[***]. Notwithstanding the foregoing, if F-star wishes to file any Patent which includes [***], then F-star shall provide Kymab with [***] written notice of such intention including full details of the proposed disclosure of such [[***], so that Kymab may itself take steps to file a Patent claiming [***] if it wishes to do so. If Kymab wishes to file such a Patent then the Parties shall [***]. |
6.6 |
Kymab Patent Prosecution and Maintenance. Kymab shall have the right, but not the obligation, at its cost, through the use of internal or outside counsel of its choosing to prepare, file, prosecute, and maintain any claims of any Kymab Patents [***]. |
6.7 |
Cooperation. Kymab agrees, at F-stars request to provide reasonable cooperation in the preparation, filing, prosecution, and maintenance of the Patents claiming the F-star mAb2. |
6.8 |
Patent Listings. F-star shall have no right to include a Patent of Kymab in any filings with Regulatory Authorities in the Territory, including as required or allowed in the United States, in the FDAs Orange Book if in the future legislation employs the Orange Book for biologics, or its alternative, or its equivalent in any other country. |
6.9 |
Enforcement of Patents. As between the Parties, F-star shall have the sole and exclusive right, but not the obligation, to enforce and defend worldwide under its |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
control, at its own expense any Patent claiming the F-star mAb2. As between the Parties, Kymab shall have the sole and exclusive right, but not the obligation, to enforce and defend worldwide under its control, at its own expense, Kymab Patents. |
6.10 |
Cooperation. The Parties agree to cooperate fully in any action pursuant to Clause 6.9. Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Where the action concerns [***] then Kymab shall have the right to be represented in such proceedings at its own cost. Unless otherwise set forth herein, the Party entitled to bring any action in accordance with this Clause 6.10 shall have the right to settle such claim; provided that no Party shall have the right to settle any action under this Clause 6.10 in a manner that diminishes or has a material adverse effect on the rights or interest of the other Party, or in a manner that imposes any costs or liability on, or involves any admission by, the other Party, without the express written consent of such other Party, such consent not to be unreasonably withheld, conditioned or delayed. The Party commencing or responding to the action shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings; provided however that the foregoing requirement shall not apply in respect of a Partys defence of opposition proceedings pursuant to Clause 6.9. |
6.11 |
Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such litigation shall be retained by the Party that has exercised its right to bring the enforcement action and any amount remaining after the reimbursement of costs incurred by or on behalf of the Party bringing such proceedings shall be treated as Net Sales for the purpose of the payment of royalties hereunder. |
6.12 |
Kymab shall have the sole and exclusive right, but not the obligation, to defend and control the defence of the validity and enforceability of any Kymab Patents. |
6.13 |
Inventors Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Partys inventors under any applicable inventor remuneration laws. |
7. |
CONFIDENTIALITY AND NON-DISCLOSURE |
7.1 |
Each Party agrees that it shall keep the Confidential Information received from the other Party confidential and shall not use or disclose the same without the prior written authority of the disclosing Party other than as specifically permitted pursuant to this Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Clause 7.1 with respect to any Confidential Information shall not include any information that: |
7.1.1 |
has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party; |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
7.1.2 |
have been in the receiving Partys possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
7.1.3 |
is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
7.1.4 |
that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
7.1.5 |
have been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Partys Confidential Information. |
7.2 |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party. |
7.3 |
Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
7.3.1 |
in the reasonable opinion of the receiving Partys legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators, but subject to Clause 7.5)); provided, that the receiving Party shall first have given prompt written notice (and to the extent possible, at least [***] notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information. In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed; |
7.3.2 |
made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with Applicable Law; |
7.3.3 |
made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining, defending or |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
enforcing a Patent in accordance with the terms of this Agreement; provided, (i) that the receiving Party shall first have given at least [***] written notice to the disclosing Party, and (ii) that reasonable measures shall be taken to assure confidential treatment of such Confidential Information, to the extent such protection is available; |
7.3.4 |
made to its or its Affiliates, financial and legal advisors who have a need to know such disclosing Partys Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, at least as restrictive as those set forth in this Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and legal advisors, to treat such Confidential Information as required under this Clause 7; |
7.3.5 |
made by the receiving Party or its Affiliates to potential or actual investors, acquirers, investment bankers, lenders, as may be necessary in connection with their evaluation of a potential or actual investment in or acquisition of the receiving Party or its Affiliates; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Clause 7; |
7.3.6 |
made by Kymab or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this clause 7 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors); or |
7.3.7 |
made by F-star or its Affiliates or Sublicensees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in connection with the development or Commercialisation of the F-star mAb2, and F-star Licensed Product or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of Kymab substantially similar to the obligations of confidentiality and non-use of F-star pursuant to this clause 7 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors and the like). |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
7.4 |
Use of Name. Except as expressly provided herein, neither of F-star nor its Affiliates, shall mention or otherwise use the name, logo, or trademark of Kymab or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of Kymab in each instance. Except as expressly provided herein, neither Kymab nor any of its Affiliates shall mention or otherwise use the name, logo, or Trademark of F-star or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of F-star. The restrictions imposed by this Clause 7.4 shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Partys counsel, is required by Applicable Law; provided, that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. |
7.5 |
Public Announcements. Neither F-star and its Affiliates, on the one hand, and Kymab and its Affiliates on the other, shall issue any public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the others prior written consent, except for any such disclosure that is, in the opinion of the disclosing entitys counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing entity are listed (or to which an application for listing has been submitted) save that (i) F-star shall be permitted to disclose that it is developing a LAG3/PD-L1 mAb2[***] at any time after the Effective Date and (ii) that F-star shall be permitted to disclose that it has licensed the rights in the Kymab PD-L1 Antibody from Kymab following commencement of GMP manufacture of the F-star mAb2 or an F-star Licensed Product by or on behalf of F-star or its Sublicensee. In the event an entity is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such entity shall submit the proposed disclosure in writing to Kymab (if the entity making the disclosure is F-star) or F-star (if the entity making the disclosure is Kymab) as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. |
7.6 |
Publications. Each Party acknowledge that its scientific publications and presentations must be strictly monitored to prevent any adverse effect from premature publication of results of the development activities hereunder. |
7.7 |
F-star and its Affiliates shall have the right to make any publications, presentations or public disclosures related to the F-star mAb2. Before any paper, abstract, poster, presentation or other publication or public disclosure (Publication) is submitted for publication, F-star shall deliver a then-current copy of the Publication to Kymab at least [***] prior to any disclosure, release or submission of such Publication. Kymab shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to F-star with appropriate comments, if any. Notwithstanding the foregoing, Kymab shall have the right within such [***] to delay the disclosure, release, or submission of the Publication for up to [***] in order (ii) to require the deletion of any Confidential Information belonging |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
to Kymab that may be disclosed by the Publication; and (ii) to permit adequate steps to be taken to secure patent or other protection for anything referred to in the Publication. F-star shall comply with Kymabs request to delete references to F-stars Confidential Information in any such paper and will withhold publication of any such paper or any presentation of same for up to [***] in order to permit the Parties to obtain Patent protection if Kymab deems it necessary. If F-star receives no comments or requests to delay the Publication within the [***]period following its delivery to Kymab, Kymab shall be deemed to approve the original version of the Publication sent to it by F-star. |
7.8 |
Notwithstanding anything herein to the contrary Kymab and its Affiliates shall have the right to make any publications, presentations or public disclosures relating to (i) any antibody other than the Kymab PD-L1 Antibody and (ii) the Kymab PD-L1 Antibody other than to the extent related to the F-star mAb2 or F-star Licensed Product, in each case without any approval, review or comment rights by the other Party under this Agreement. |
7.9 |
Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first Party does not retain rights under the surviving provisions of this Agreement: (a) as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) as soon as reasonably practicable, deliver to the requesting Party, at the other Partys expense, all copies of such Confidential Information in the possession of the other Party; provided, that the other Party shall be permitted to retain one (1) copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder, as required by Applicable Law, or for archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Partys automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Partys standard archiving and back-up procedures, but not for any other use or purpose. |
7.10 |
Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for [***] after the expiry or earlier termination of this Agreement. |
8. |
WARRANTIES AND COVENANT |
8.1 |
Each Party warrants, as of the Effective Date as follows: |
8.1.1 |
Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
8.1.2 |
Authorization. The execution and delivery of this Agreement and the performance by that Party of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) that Partys charter documents, bylaws, or other organizational documents, (b) in |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
any material respect, any agreement, instrument, or contractual obligation to which such Party is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to that Party. |
8.1.3 |
Binding Agreement. This Agreement is a legal, valid, and binding obligation of that Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). |
8.1.4 |
No Inconsistent Obligation. That Party is not under any obligation and shall not during the term of this Agreement agree to be subject to any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfilment of its obligations hereunder. |
8.1.5 |
Except as disclosed in Schedule 3, there are no written claims or allegations, judgments or settlements against, or amounts with respect thereto owed by, that Party or any of their respective Affiliates relating to a claim that any activities or products covered by Kymab Patents, infringe the intellectual property rights of any Third Party. |
8.2 |
Kymab warrants that at the Effective Date Kymab and its Affiliates have Control of all Patents, Know How and Data licensed to F-star hereunder and after the Effective Date none of Kymab or its Affiliates shall enter into any agreement that conflicts with or restricts the rights granted to F-star under this Agreement. |
8.3 |
Non-Debarment. F-star hereby undertakes to Kymab that it will not use in any capacity, in connection with the manufacture, use, import, development or sale of the Licensed Products during the Term of this Agreement, any individual or entity who has been debarred by the relevant health authorities. |
8.4 |
DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NONE OF F-STAR, OR KYMAB OR ANY OF THEIR RESPECTIVE AFFILIATES MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. |
9. |
INDEMNITY |
9.1 |
No Consequential Damages. Subject to Clause 9.6, but otherwise notwithstanding any other provision of this Agreement, neither Party shall be liable to the other Party |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
or to any Affiliate of the other Party for any lost profits, business opportunities, special, indirect, consequential, exemplary, or punitive damages of any nature arising under or in relation to this Agreement even if that Party was advised in advance of the possibility of such loss or damage. |
9.2 |
Indemnification by F-star. F-star shall, subject to Clauses 9.1 and 9.6, indemnify, Kymab, its Affiliates, and its and their respective directors, officers, employees and agents (collectively the Kymab Indemnified Parties) against any and all claims, causes of action, demands, liabilities, losses, damages, costs or expenses, including reasonable attorneys fees, in each case asserted by a Third Party (each a Loss and collectively Losses) incurred or suffered by the Kymab Indemnified Parties to the extent such Loss arose out of or was caused by the development, manufacture, use, distribution, marketing, promotion or sale of any F-star mAb2 or F-star Licensed Product by or on behalf of F-star or its Affiliates or sublicensees in the Territory; except, in all cases, to the extent that such Loss arises out of the negligence or wilful misconduct of Kymab. |
9.3 |
Notification of Liabilities/Losses. A person or entity entitled to indemnification under this Clause 9 (an Indemnified Party) shall give prompt written notification (within [***]) to F-star of the commencement or notice of Loss for which indemnification may be sought or, if earlier, upon the assertion of any such Loss (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Loss as provided in this Clause 9.3 shall not relieve F-star of its indemnification obligation under this Agreement except, and only, to the extent that F-star is materially prejudiced as a result of such failure to give notice). F-star shall be liable for any reasonable legal fees and expenses subsequently incurred in connection with the defence of such Loss after receiving such notice. Kymab shall thereafter keep F-star informed of any Losses. |
9.4 |
In the case of a Loss for which Kymab seeks indemnification under Clause 9.2, Kymab shall permit F-star to direct and control the defence of the Loss and shall provide such reasonable assistance as is reasonably requested by F-star (at F-stars cost) in the defence of the Loss, provided always that nothing in this Clause 9.3 shall permit F-star to mak`e any admission on behalf of Kymab, or to settle any claim or litigation which would impose any financial obligations on Kymab or would result in any loss or diminution of the scope, validity or enforceability of the Kymab intellectual property without the prior written consent of Kymab, such consent not to be unreasonably withheld or delayed. |
9.5 |
Mitigation. Where Kymab makes a claim under this Clause 9 Kymab shall take all reasonable steps to mitigate and/or minimise the Losses suffered and shall not do anything nor fail to do something which would have the effect of increasing the Losses. |
9.6 |
Restriction on Limitation of Liability. Neither Party limits or excludes its liability for fraud or fraudulent misrepresentation, nor for death or personal injury arising from its negligence. |
9.7 |
Insurance. F-star shall procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
normal business practices of prudent companies similarly situated at all times during which any Licensed Product is being clinically tested with human subjects or commercially distributed or sold. It is understood that such insurance shall not be construed to create a limit of F-stars liability with respect to its indemnification obligations under this Clause 9. |
10. |
TERM AND TERMINATION |
10.1 |
This Agreement shall commence on the Effective Date and shall continue in force and effect unless earlier terminated in accordance herewith (the Term). |
10.2 |
F-star shall have the right by [***] written notice to Kymab to terminate its rights and obligations in relation to the F-star mAb2 or F-star Licensed Products. On any termination by F-star of its rights and obligations pursuant to this Clause 10.1 save as provided for in Clause 10.8, F-star shall have no obligations or liability to Kymab in respect of the F-star mAb2 or Licensed Products. |
10.3 |
Termination for Breach. Kymab shall have the right to terminate this Agreement insofar as it relates to the licences and rights granted by Kymab in the event that F-star commits a material breach of this Agreement. Kymab shall first provide written notice to F-star, which notice shall clearly describe the nature of the breach. F-star shall have [***] in which to cure the breach (or such longer period as is set out in the notice). If F-star fails to cure the breach within [***] (or such longer period as is set out in the notice) then Kymab may terminate this Agreement insofar as it relates to the licences and rights granted by Kymab immediately on written notice. |
10.4 |
F-star will have the right to terminate this Agreement in respect of Kymabs rights upon written notice to Kymab in the event that (i) Kymab or any of its Affiliates directly asserts or directs or assists a Third Party to challenge in any court or patent office the validity or enforceability of any mAb2 Patent controlled by F-star and (ii) Kymab does not cease such activity within [***] of such notice from F-star. |
10.5 |
Kymab will have the right to terminate this Agreement in respect of F-stars rights upon written notice to F-star in the event that (i) F-star or any of its Affiliates directly asserts or directs or assists a Third Party to challenge in any court or patent office the validity or enforceability of any Kymab Patent and (ii) F-star does not cease such activity within [***] of such notice from Kymab. |
10.6 |
Effects of Termination. The rights and obligations under this Agreement shall immediately terminate with respect to the F-star mAb2 or Licensed Products for which this Agreement has been terminated. The obligations under this Agreement shall continue for the F-star mAb2 or Licensed Products for which this Agreement has not been terminated. In the event that F-star terminates its rights under this Agreement pursuant to Clause 10.2 then the provisions of clause 3.4.2 shall expire and F-star shall no longer be subject to the restrictions therein. |
10.7 |
Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
10.8 |
Termination or expiration of this Agreement as a whole or with respect to F-stars mAb2 and Licensed Products for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, Clauses 5.9, 5.10, 5.11, 5.12, 6.1, 6.2, 6.3, 6.4, 6.5 6.6, 6.7, 6.8, 7, 8.4, 9, 10.6, 10.7, 10.8 and 11 shall survive the termination or expiration of this Agreement for any reason. |
11. |
MISCELLANEOUS |
11.1 |
Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts, or other labour disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within [***] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. |
11.2 |
Assignment. Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed no Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided, that a Party may make such an assignment without the other Partys consent to (a) its Affiliate, or (b) in the case of F-star, to F-star Ltd, F-star Delta or F-star GmbH or to their respective Affiliates, or (c) to a successor, whether in a merger, sale of stock, sale of assets or any other transaction, of the business to which this Agreement relates. With respect to an assignment to an Affiliate, or in the case of F-star, to F-star Ltd, F-star Delta or F-star GmbH or to their respective Affiliates, the assigning Party shall remain responsible for the performance by such Affiliate of the rights and obligations hereunder. Any attempted assignment or delegation in violation of this Clause 11.2 shall be void and of no effect. All validly assigned and delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of F-star or Kymab, as the case may be. The permitted assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement. Without limiting the foregoing, the grant of rights set forth in this Agreement shall be binding upon any successor or permitted assignee of F-star, F-star GmbH, F-star Delta or F-star Ltd, and the obligations of Kymab, including the payment obligations, shall run in favour of any such successor or permitted assignee of F-stars benefits under this Agreement. |
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11.3 |
Notwithstanding anything to the contrary herein, no Know-How, Patents or other intellectual property rights not Controlled by F-star or Kymab or any of their respective Affiliates before a Change in Control of such Person will be Controlled by such Person for purposes of this Agreement after such Change in Control. |
11.4 |
Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect. |
11.5 |
Governing Law, Jurisdiction and Service. |
11.5.1 |
Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England. |
11.5.2 |
Dispute Resolution. If a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute), it shall be resolved pursuant to this Clause 11.5. |
11.5.3 |
General. Any Dispute shall first be referred to the Chief Executive Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Chief Executive Officers shall be conclusive and binding on the Parties. If the Chief Executive Officers are not able to agree on the resolution of any such issue within [***] (or such other period of time as mutually agreed by the Chief Executive Officers) after such issue was first referred to them either Party may commence proceedings in the English courts |
11.6 |
Notices. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, or (b) sent by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified below or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Clause 11.6. Such notice shall be deemed to have been given (i) as of the date of delivery if delivered |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
on a Business Day (at the place of delivery or the next Business Day if the date of delivery is not a Business Day) by hand; and (ii) on the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Clause 11.6 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. |
Address for Notice.
If to Kymab, to:
Kymab Limited.
The Bennet Building (B930),
Babraham Research Campus,
Cambridge,
United Kingdom, CB22 3AT
Attention: Chief Executive Officer
Facsimile:
and
If to F-star:
F-star Beta Ltd.
Eddeva B920
Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Legal Department
11.7 |
Entire Agreement; Amendments. Save in respect of the confidentiality agreement entered into by the Parties on 28 May 2015 and the Material Transfer Agreement, this Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. |
11.8 |
English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. |
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11.9 |
Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein. |
11.10 |
Third Parties. With the exception of a Sublicensee pursuant to Clause 3.2, a person who is not a party to this agreement shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this agreement, but this does not affect any right or remedy of a third party which exists, or is available, apart from under that Act. |
11.11 |
Further Assurance. Each party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other party its rights and remedies under this Agreement. |
11.12 |
Relationship of the Parties. It is expressly agreed that F-star, on the one hand, and Kymab, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for tax purposes. Neither F-star, on the one hand, nor Kymab, on the other hand, shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party. |
11.13 |
Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by facsimile or electronically transmitted signatures and such signatures shall be deemed to bind each party hereto as if they were original signatures. |
[SIGNATURE PAGES FOLLOW.]
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THIS AGREEMENT IS EXECUTED as of the Effective Date by the authorized representatives of the Parties:
KYMAB LIMITED. | ||
By: |
/s/ David Chiswell |
|
Name: | David Chiswell | |
Title: | Board Advisor |
F-STAR BETA LIMITED | ||
By: |
/s/ Tolga Hassan |
|
Name: | Tolga Hassan | |
Title: | CFO |
and by the authorized representative of F-star Delta Limited solely for the purposes of clause 3.4.2 and 3.4.3.
F-STAR DELTA LIMITED | ||
By: |
/s/ Tolga Hassan |
|
Name: | Tolga Hassan | |
Title: | CFRO |
and by the authorized representative of F-star Biotechnology Limited solely for the purposes of clause 3.4.2 and 3.4.3.
F-STAR BIOTECHNOLOGY LIMITED | ||
By: |
/s/ Tolga Hassan |
|
Name: | Tolga Hassan | |
Title: | CFRO |
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SCHEDULE 1
PART A
[***]
[***]
[***]
[***]
[***]
[***]
[***]
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PART B
[***]
|
[***] |
|
[***] |
|
[***] |
1) |
[***] |
2) |
[***] |
3) |
[***] |
4) |
[***] |
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SCHEDULE 2
[***]
[***]
[***]
[***]
[***]
[***]
[***]
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
SCHEDULE 3
[***]
[***]
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
SCHEDULE 4
Appointment of Expert
If either Party wishes to appoint an independent expert (the Expert) to determine any matter pursuant to any Clause of this Agreement, the following procedures will apply:
1. |
The Party wishing to appoint the Expert (the Appointing Party) will serve a written notice on the other Party (the Responding Party). The written notice will specify the Clause pursuant to which the appointment is to be made and will contain reasonable details of the matter(s) which the Appointing Party wishes to refer to the Expert for determination |
2. |
The Parties shall within [***] following the date of the Appointing Partys written notice use all reasonable efforts to agree who is to be appointed as the Expert to determine the relevant matter(s). If the Parties are unable to agree upon the identity of the Expert within that timescale, [***] upon written request of either Party. |
3. |
Each Party will within [***] following appointment of the Expert, prepare and submit to the Expert and the other Party a detailed written statement setting out its position on the matter(s) in question and including any proposals which it may wish to make for settlement or resolution of the relevant matter. |
4. |
Each Party will have [***] following receipt of the other Partys written statement to respond in writing thereto. Any such response will be submitted to the other Party and the Expert. |
5. |
The Expert will if he/she deems appropriate be entitled to seek clarification from the Parties as to any of the statements or proposals made by either Party in their written statement or responses. Each Party will on request make available all information in its possession and shall give such assistance to the Expert as may be reasonably necessary to permit the Expert to make his/ her determination. |
6. |
The Expert will issue his/her decision on the matter(s) referred to him/ her in writing as soon as reasonably possible, but at latest within [***] following the date of his/ her appointment. The Experts decision shall (except in the case of manifest error) be final and binding on the Parties. |
7. |
The Expert will at all times act as an independent and impartial expert and not as an arbitrator. |
8. |
The Experts charges will be borne [***]. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
|
Tel: +44 (0)1223 497400 Fax: +44 (0)1223 497461 cambridge@f-star.com
F-star Beta Limited Eddeva B920 Babraham Research Campus Cambridge CB22 3AT United Kingdom
www.f-star.com |
Chief Executive Officer
KYMAB LIMITED
The Bennet Building (B930)
Babraham Research Campus
Cambridge
United Kingdom
CB22 3AT
15 November 2018
Dear Sirs
Novation of contract
We refer to the Amended and Restated Licence Agreement between Kymab Limited (Kymab) and F-star Beta Limited (Beta) dated 19 April 2016, and amended and restated on the Deed Effective Date as attached as Schedule 1 to this letter deed (together the Contract).
In this letter deed, words and expressions defined in the Contract and used in this letter deed have the meaning set out in the Contract.
As previously communicated, F-star Delta (as defined below) has recently entered into a new strategic collaboration to develop bispecific antibodies in immuno-oncology with Ares Trading S.A., an Affiliate of Merck KGaA (Ares). As a result, Beta (defined as F-star under the Contract) wishes to novate the Contract to F-star Delta (as defined below) on the terms set out below, and in accordance with the assignment provisions of Clause 11.2 of the Contract.
F-star Delta Limited is a company registered in England and Wales (registered number 10543154) and its registered office is at Eddeva 11920, Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT (F-star Delta).
With effect from the date of the last signature of this letter deed (the Deed Effective Date), Kymab, Beta and F-star Delta hereby:
1. |
[***]; |
F-star Beta Limited
A company registered in England and Wales Company No. 9263520 VAT 202282357
Registered address: Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT, United Kingdo
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
2. |
irrevocably and unconditionally consent to the novation of the Contract by the substitution of F-star Delta for Beta and expressly agree that, as from the Deed Effective Date, the Contract shall be deemed to have been made with F-star Delta for all purposes and in respect of all rights, benefits, liabilities and obligations arising thereunder; |
3. |
agree that, on and from the Deed Effective Date, F-star Delta shall enjoy all the rights and benefits of Beta under the Contract (and that Kymab shall perform the Contract and be bound by its terms in every way as if F-star Delta were the original party to them in place of Beta) and accept the liability of F-star Delta to perform all obligations under the Contract after the Deed Effective Date in substitution of the liability of Beta; |
4. |
agree that Kymab shall not make any claim or demand whatsoever against F-star Delta in respect of any liabilities, obligations or duties relating to the performance of the Contract on or prior to the Deed Effective Date or otherwise accrued or referable to the period up to and including the Deed Effective Date and will instead make any such claim or demand against Beta; |
5. |
agree that Kymab shall not make any claim or demand whatsoever against Beta in respect of any liabilities, obligations or duties relating to the performance of the Contract after the Deed Effective Date and will instead make any such claim or demand against F-star Delta; and |
6. |
agree that: |
a. |
nothing in this letter deed shall affect or prejudice any rights, claim or demand whatsoever which either Beta or Kymab may have against each other in connection with the parties obligations under the Contract relating to the period up to and including the Deed Effective Date; |
b. |
each party shall, and shall ensure that any necessary third party will, execute all documents and do all acts and things as may reasonably be required to give full effect to the provisions of this letter deed; |
c. |
no variation, supplement, deletion or replacement of or from this letter deed or any of its terms shall be effective unless made in writing and signed by or on behalf of each party; |
d. |
if a provision of this letter deed is found to be illegal, invalid or unenforceable, then to the extent it is illegal, invalid or unenforceable, that provision will be given no effect and will be treated as though it were not included in this letter deed, but the validity or enforceability of the remaining provisions of this letter deed will not be affected; |
F-star Beta Limited
A company registered in England and Wales Company No. 9263520 VAT 202282357
Registered address: Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT, United Kingdo
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
e. |
each party shall bear its own costs and expenses in relation to the negotiation, preparation, execution and implementation of this letter deed; |
f. |
this letter deed may be entered into in any number of counterparts and any party may enter into this letter deed by executing any counterpart. A counterpart constitutes an original of this letter deed and all executed counterparts together have the same effect as if each party had executed the same document; |
g. |
a person who is not a party to this letter deed has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce this letter deed; |
h. |
this letter deed, the jurisdiction clause contained in it and all non-contractual obligations arising in any way whatsoever out of or in connection with this letter deed are governed by, construed and take effect in accordance with English law; and |
i. |
the courts of England have exclusive jurisdiction to settle any claim, dispute or matter of difference which may arise in any way whatsoever out of or in connection with this letter deed (including, without limitation, claims for set off or counterclaim) or the legal relationships established by this letter deed. |
The Contract will in all other respects continue on its existing terms except that, on and from the Deed Effective Date, all references to Beta in the Contract will be read and construed as references to F-star Delta.
If you have any questions concerning the proposed transfer, please contact [***] at [***].
Please sign and return the enclosed copy of this letter deed to acknowledge your agreement to the novation of the Contract on the above terms.
We agree to the novation of the Contract to F-star Delta on the terms set out in this letter deed, this letter has been executed as a deed and is delivered on the Deed Effective Date.
F-star Beta Limited
A company registered in England and Wales Company No. 9263520 VAT 202282357
Registered address: Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT, United Kingdo
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Executed as a Deed by F-star Delta Limited acting by:
Director:
Director/Secretary:
Date:
Executed as a Deed by F-star Delta Limited acting by:
Director:
Director/Secretary:
Date:
Executed as a Deed by F-star Delta Limited acting by:
Director:
Director/Secretary:
Date:
F-star Beta Limited
A company registered in England and Wales Company No. 9263520 VAT 202282357
Registered address: Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT, United Kingdo
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
Schedule 1
Amended and Restated Licence Agreement
F-star Beta Limited
A company registered in England and Wales Company No. 9263520 VAT 202282357
Registered address: Eddeva B920, Babraham Research Campus, Cambridge, CB22 3AT, United Kingdo
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Exhibit 10.36
Confidential
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
Execution Version
LICENSE AND COLLABORATION AGREEMENT
between
F-STAR DELTA LIMITED,
F-STAR BETA LIMITED,
F-STAR BIOTECHNOLOGY LIMITED,
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND
ENTWICKLUNGSGES.M.B.H
AND
ARES TRADING S.A.
Dated as of 13 May 2019
CONFIDENTIAL
Page | ||||
ARTICLE 1 DEFINITIONS |
2 | |||
ARTICLE 2 COLLABORATION MANAGEMENT |
26 | |||
ARTICLE 3 PRECLINICAL DEVELOPMENT PROGRAMS |
31 | |||
ARTICLE 4 COMMERCIALISATION OF SUBJECT MAB2 AND LICENSED PRODUCTS |
35 | |||
ARTICLE 5 GRANT OF RIGHTS AND EXCLUSIVITY |
36 | |||
ARTICLE 6 REGULATORY MATTERS |
44 | |||
ARTICLE 7 PAYMENTS AND RECORDS |
46 | |||
ARTICLE 8 INTELLECTUAL PROPERTY |
54 | |||
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
67 | |||
ARTICLE 10 DATA PROTECTION AND PRIVACY |
75 | |||
ARTICLE 11 WARRANTIES AND COVENANTS |
79 | |||
ARTICLE 12 INDEMNITY |
86 | |||
ARTICLE 13 TERM AND TERMINATION |
93 | |||
ARTICLE 14 MISCELLANEOUS |
105 |
- i
CONFIDENTIAL
THIS LICENSE AND COLLABORATION AGREEMENT is made and entered into on 13 May 2019 (the Effective Date) by and between:
(1) |
F-STAR DELTA LIMITED, a limited company incorporated under the laws of England and Wales with company number 10543154, whose registered office is at Eddeva B920 Babraham Research Campus, Cambridge, CB22 3AT, United Kingdom (Delta); |
(2) |
F-STAR BETA LIMITED, a limited company incorporated under the laws of England and Wales with company number 9263520, whose registered office is at Eddeva B920 Babraham Research Campus, Cambridge, CB22 3AT, United Kingdom (Beta); |
(3) |
F-STAR BIOTECHNOLOGY LIMITED, a limited company incorporated under the laws of England and Wales with company number 8067987, whose registered office is at Eddeva B920 Babraham Research Campus, Cambridge, CB22 3AT, United Kingdom (F-star); |
(4) |
F-STAR BIOTECHNOLOGISCHE FORSCHUNGS-UND ENTWICKLUNGSGES.M.B.H, a limited liability company incorporated under the laws of the Republic of Austria with registered number FN 279896m - UID ATU62738988, whose registered address is at Schwartzbergplatz 7, A-1030, Vienna, Austria (F-star GmbH); and |
(5) |
ARES TRADING S.A., a private limited company incorporated under the laws of Switzerland, having its registered office at Zone industrielle de lOuriettaz, 1170 Aubonne, Switzerland (Ares), |
(each of Delta, Beta, F-star, F-star GmbH and Ares being a Party and together the Parties; and each of Delta, Beta, F-star and F-star GmbH being an F-star Party and together the F-star Parties).
RECITALS
(A) |
Delta Controls (as defined in ARTICLE 1) certain intellectual property rights with respect to mAb2 (as defined in ARTICLE 1) and Licensed Products (as defined in ARTICLE 1) in the Territory (as defined in ARTICLE 1). |
(B) |
Delta and Ares have agreed to collaborate on the preclinical development of various Subject mAb2 (as defined in ARTICLE 1). Delta will undertake a program of preclinical development in respect of such Subject mAb2, in each case in accordance with the terms and conditions set out in this Agreement. |
- 1
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(C) |
The Parties have agreed that, pursuant to this Agreement, the Subject mAb2 shall be the subject of preclinical programs that will be conducted by Delta until it has completed agreed data packages. On delivery of the relevant data package, on a preclinical program-by-preclinical program basis, Ares will have the option to take over the development of such preclinical program or to terminate this Agreement in respect of such preclinical program. If Ares elects to continue such preclinical program, it shall pay certain payments, e.g. milestone payments and royalties, to Delta. |
OPERATIVE PROVISIONS
It is agreed as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement and the Schedules to this Agreement the following capitalised terms, whether used in the singular or plural, shall have the meanings set out below:
1.1 |
Accepted mAb² Target Pair means the Targets bound by a Subject mAb². |
1.2 |
Adequate Country means a country or territory outside the European Economic Area that the European Commission has deemed to provide an adequate level of protection for Personal Data pursuant to a decision made in accordance Article 45(1) of the GDPR. |
1.3 |
Acquisition Notice shall have the meaning set forth in Section 13.6.2. |
1.4 |
Adverse Event means any serious untoward medical occurrence in a patient or subject who is administered a Licensed Product, but only if and to the extent that such serious untoward medical occurrence is required under Applicable Laws to be reported to applicable Regulatory Authorities. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.5 |
Affiliate means, with respect to a Party, any Person that, at the relevant time, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For the purposes of this definition, control and, with correlative meanings, the terms controlling, controlled by and under common control with means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). |
1.6 |
Agreement means this agreement and all Schedules, appendices and other addenda attached hereto as any of the foregoing may be amended in accordance with the provisions of this Agreement. |
1.7 |
Alliance Manager has the meaning set forth in Section 2.9. |
1.8 |
Antibody means an immunoglobulin (Ig) molecule or fragment thereof that binds to an antigen and shall include monospecific and multispecific immunoglobulin molecules or a nucleic acid-containing molecule that encodes such an immunoglobulin molecule or fragment thereof. |
1.9 |
Applicable DP Laws means: (i) the EU GDPR; and (ii) to the extent applicable, the data protection or privacy laws of any other country. |
1.10 |
Applicable Law means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organisations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.11 |
Approved Subcontractors means those subcontractors agreed to by the Parties in writing and includes (in the case of sub-contracting by Delta) F-star and Beta and (in the case of sub-contracting by any Party) the subcontractors listed in Schedule 3.5. |
1.12 |
Ares Background IP means, collectively, Ares Background Patents and Ares Background Know-How. |
1.13 |
Ares Background Know-How means any and all Know-How Controlled by Ares on the Effective Date or during the Term that is developed or invented as a result of performing activities outside the scope of each Preclinical Program Development Plan and that is necessary for the research, discovery or Exploitation of any Subject mAb2 or Licensed Product. |
1.14 |
Ares Background Patents means any and all Patents Controlled by Ares on the Effective Date or during the Term that claim inventions made as a result of performing activities outside the scope of each Preclinical Program Development Plan and that in the absence of a licence would be infringed by the research, discovery or Exploitation of any Subject mAb2 or Licensed Product. |
1.15 |
Ares Indemnitees has the meaning set forth in Section 12.2. |
1.16 |
Ares IP means, collectively, Ares Patents and Ares Know-How. |
1.17 |
Ares Know-How means any and all Ares Background Know-How together with any Know-How comprised within the Ares Post-Data Package Improvements, in each case that is necessary or useful for the research, discovery or Exploitation of any Subject mAb2 or Licensed Product. |
1.18 |
Ares Patents means any and all Ares Background Patents and any and all Patents that specifically claim any Subject mAb2 that are comprised within the Ares Post-Data Package Improvements and/or that cover or claim Know-How comprised within Ares Post-Data Package Improvements. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.19 |
Ares Post-Data Package Improvements has the meaning set forth in Section 8.1.6. |
1.20 |
Beta In-Licences means any agreement entered into by Beta prior to the Preclinical Program Data Package Delivery Date in respect of any Subject mAb2 pursuant to which Beta has in-licensed IP that is necessary for the Development or Commercialisation of the relevant Subject mAb2. |
1.21 |
Beta IP means, collectively, Beta Patents and Beta Know-How. |
1.22 |
Beta Know-How means any and all Know-How Controlled by Beta on the Effective Date or during the Term, together with any Know-How comprised within the Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements, in each case that is necessary or useful for the research, discovery or Exploitation of any Subject mAb2. For the avoidance of doubt, Beta Know-How shall include any Know-How that specifically relates to an Fcab or Fab comprising the components of a Subject mAb2 but, subject to the foregoing, shall not include the F-star Know-How, or Delta Know-How. |
1.23 |
Beta Patents means any and all Patents Controlled by Beta on the Effective Date or during the Term that would be infringed by the research, discovery or Exploitation of any Subject mAb2, including, but not limited to, the Patents set forth on Schedule 1.23, but excluding the F-star Patents and Delta Patents. For the avoidance of doubt, Beta Patents shall include (i) any Fcab Patents, (ii) any Patents Controlled by Beta that claim a Fab comprised within a Subject mAb2, and (iii) any Patents comprised within the Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements and/or that cover or claim Know-How comprised within the Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.24 |
Beta Post-Data Package Improvements has the meaning set forth in Section 8.1.6(b). |
1.25 |
Beta Pre-Data Package Improvements has the meaning set forth in Section 8.1.5(b). |
1.26 |
Breaching Party has the meaning set forth in Section 13.4. |
1.27 |
Business Day means a day, other than a Saturday or Sunday, on which banking institutions in Frankfurt, Germany and London, England are open for non-automated business. |
1.28 |
Calendar Quarter means each successive period of three (3) calendar months commencing on 1st January, 1st April, 1st July and 1st October, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of 1st January, 1st April, 1st July or 1st October after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. |
1.29 |
Calendar Year means each successive period of twelve (12) calendar months commencing on 1st January and ending on 31st December, except that the first Calendar Year of the Term shall commence on the Effective Date and end on 31st December of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on 1st January of the year in which the Term ends and end on the last day of the Term. |
1.30 |
[***] |
1.31 |
Clinical Studies means Phase I, Phase II, Phase III, Phase IV and such other tests and studies in human subjects that are required by Applicable Law, or otherwise conducted or recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the approved indications for such Licensed Product. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.32 |
Combination Product means a product containing the Licensed Product together with one or more other active ingredients, or with one or more products, devices, pieces of equipment or components, whether in a single composition or separate composition. |
1.33 |
Consolidation Requirement shall have the meaning set forth in Section 11.4.8(c). |
1.34 |
Commercialisation means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a molecule or product, including activities related to marketing, promoting, distributing, importing and exporting such molecule or product, and, for the purposes of setting out the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting medical affairs activities and conducting Phase IV, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, to Commercialise and Commercialising means to engage in Commercialisation, and Commercialised has a corresponding meaning. |
1.35 |
Commercially Reasonable Efforts means the expenditure of those efforts and resources that are consistent with the efforts and resources (including efforts as to the speed of research and the quality of involved sub-contractors and selected resources) that [***] would typically devote to the development and furtherance of compounds or products of similar market potential at a similar stage in Development or product life, with the intention of their Commercialisation and taking into account (without limitation) issues of safety and efficacy, and, without limitation to the foregoing, to the fulfilment of the tasks set forth in the relevant Preclinical Program Development Plan and any subsequent modification thereof and to any additional activities which could reasonably have been expected to be required in order to satisfy the explicit requirements of the relevant Preclinical Program Development Plan or which may be agreed between Delta and Ares from time to time; provided that (i) in no event shall |
- 7
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Commercially Reasonable Efforts be anything less than reasonable efforts and (ii) a Party shall not be considered to have used Commercially Reasonable Efforts if [***]. |
1.36 |
Confidential Information means any Information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to any of the other Parties (or to an Affiliate or representative of any such Party) in connection with this Agreement, whether prior to, on, or after the Effective Date, including Information relating to the terms of this Agreement, any Fcab, any Fab, any mAb2 or any Licensed Product, any Exploitation of any Fcab, any Fab, any mAb2 or any Licensed Product, any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates, or the scientific, regulatory or business affairs or other activities of a Party. For the avoidance of doubt, any disclosure of Confidential Information by F-star, F-star GmbH, and Beta to Ares or its Affiliates shall be deemed to be a disclosure on behalf of Delta. Notwithstanding the foregoing, (a) Beta IP will be considered Confidential Information of Beta, (b) F-star IP will be considered Confidential Information of F-star, (c) Delta IP will be considered Confidential Information of Delta and (d) Ares Background IP will be considered Confidential Information of Ares. |
1.37 |
Control means, with respect to any item of Information, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of any licenses and other grants in ARTICLE 5 and Sections 13.6.6, 13.8 and 13.9), to grant a licence, sublicence or other right to or under such Information, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party [***]. |
1.38 |
Cover, Covering or Covered means, with respect to a Licensed Product and relevant Patent Rights, that the making, using, selling, or offering for sale of such Licensed Product would, but for a license, |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
infringe a Valid Claim of the relevant Patent Rights in any country in which any such activity occurs or that the Licensed Product is claimed in or covered by a Pending Claim. |
1.39 |
Data Breach has the meaning set forth in Section 10.9. |
1.40 |
Data Receiving Party has the meaning set forth in Section 10.11.1. |
1.41 |
Default Notice has the meaning set forth in Section 13.4.1. |
1.42 |
Delta Indemnitees has the meaning set forth in Section 12.1. |
1.43 |
Delta IP means, collectively, Delta Patents and Delta Know-How. |
1.44 |
Delta IP Licence means the IP licence agreement dated 4 June 2017 between Delta, Beta and F-star as amended and restated on or around the date of this Agreement, as such agreement may be amended or restated from time to time. |
1.45 |
Delta Know-How means (i) any Know-How owned or Controlled by Delta on the Effective Date, and (ii) any and all Know-How that is developed or invented after the Effective Date that is comprised within the Delta Pre-Data Package Improvements. For the avoidance of doubt, Delta Know-How does not include any Beta Know-How, or any F-star Know-How. |
1.46 |
Delta Patent Filing Jurisdictions shall have the meaning set forth in Section 8.2.2. |
1.47 |
Delta Patents means (i) any and all Patents that specifically claim any Subject mAb2 (but not the Fcab or Fab components independently of the Subject mAb2) invented before the Effective Date by Delta or its Affiliates or agents, or on their behalf, including by Beta and/or F-star and/or their Affiliates, including, but not limited to, the Patents set forth on Schedule 1.47; and (ii) any and all Patents that specifically claim any Subject mAb2 (but not the Fcab or Fab components independently of the Subject mAb2) invented after the Effective Date that are comprised within the Delta Pre-Data |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Package Improvements and/or that cover or claim Know-How comprised within the Delta Pre-Data Package Improvements. For the avoidance of doubt, Delta Patents do not include any Beta Patents or F-star Patents. |
1.48 |
Delta Pre-Data Package Improvements has the meaning set forth in Section 8.1.5(a). |
1.49 |
Delta Support Services Agreement means the Support Services Agreement dated 4 June 2017 between Delta, F-star, F-star GmbH and Beta as amended and restated on or around the date of this Agreement, as such agreement may be amended or restated from time to time. |
1.50 |
Development means all activities related to pre-clinical and other non-clinical research, testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of drug approval applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval; and Development shall include, for the avoidance of doubt, any submissions and activities required in support thereof, required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved molecule or product. When used as a verb, Develop means to engage in Development. |
1.51 |
Dispute has the meaning set forth in Section 14.8. |
1.52 |
Effective Date means the effective date of this Agreement as set forth in the parties clause at the beginning of this Agreement. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.53 |
EMA means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.54 |
Enforcement Notification shall have the meaning set forth in Section 13.6.4(a). |
1.55 |
EU GDPR means GDPR and to the extent the GDPR is no longer applicable in the United Kingdom, any implementing legislation or legislation having equivalent effect in the United Kingdom. |
1.56 |
Euro or means the official common currency of the Eurozone countries (Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovakia, Slovenia, and Spain). |
1.57 |
Excluded Matters has the meaning set forth in Section 2.7.1. |
1.58 |
Exploit, Exploiting or Exploitation means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialise, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of. |
1.59 |
Fab means the region on an Antibody that binds to antigens which is composed of one (1) constant and one (1) variable domain of each of the heavy and the light chain. |
1.60 |
Fab Patent means any Patent Controlled by Beta that specifically claims the composition of matter or the method of use in the Field of a Fab that comprises part of a Subject mAb2. |
1.61 |
Fab Target means a Target to which the Fab component of a mAb2 binds. |
1.62 |
[***]. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.63 |
Fcab means an Fc fragment of an Antibody comprising both a CH2 and CH3 domain wherein there are antigen binding loops in the CH3 domain that confer specific binding of the Fc fragment to a defined target antigen, and said Fcab has been generated using any proprietary technology Controlled by F-star. |
1.64 |
Fcab Patent means any Patent Controlled by Beta that specifically claims the composition of matter or the method of use in the Field of an Fcab that comprises part of a Subject mAb2. |
1.65 |
Fcab Target means a Target to which the Fcab component of a mAb2 binds. |
1.66 |
FDA means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.67 |
FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.68 |
Field means the treatment and prevention of diseases in humans. |
1.69 |
First Commercial Sale means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after Regulatory Approval for such Licensed Product has been obtained in such country. Sales prior to receipt of Regulatory Approval for such Licensed Product, such as so-called treatment IND sales, named patient sales, and compassionate use sales, shall not be construed as a First Commercial Sale. |
1.70 |
F-star Aggregate Support Limit has the meaning set forth in Section 5.7. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.71 |
F-star Business Warranties means those warranties set forth in Schedule 11.2. |
1.72 |
F-star In-Licences means any agreement entered into by F-star prior to the Preclinical Program Data Package Delivery Date in respect of the relevant Subject mAb2 pursuant to which F-star has in-licensed IP that is necessary for the Development or Commercialisation of the relevant Subject mAb2. |
1.73 |
F-star IP means, collectively, F-star Patents and F-star Know-How. |
1.74 |
F-star Know-How means any and all Know-How Controlled by F-star on the Effective Date or during the Term, together with any Know-How comprised within the F-star Pre-Data Package Improvements that is necessary or useful for the research, discovery or Exploitation of any Subject mAb2. |
1.75 |
F-star Patents means any and all Patents Controlled by F-star on the Effective Date or during the Term that would be infringed by the research, discovery or Exploitation of any Subject mAb2, including, but not limited to, the Patents set forth on Schedule 1.75, but excluding the Beta Patents and Delta Patents. For the avoidance of doubt, F-star Patents shall include any Patents comprised within the F-star Pre-Data Package Improvements and/or that that cover or claim Know-How comprised within the F-star Pre-Data Package Improvements. |
1.76 |
F-star Pre-Data Package Improvements has the meaning set forth in Section 8.1.5(c). |
1.77 |
F-star Solicitors means [***] |
1.78 |
FTL means F-star Therapeutics Limited, a limited company incorporated under the laws of England and Wales with registered number 11532458. |
1.79 |
GDPR means the General Data Protection Regulation (EU) 2016/679. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.80 |
IFRS means the International Financial Reporting Standards, the set of accounting standards and interpretations and the framework in force on the Effective Date and adopted by the European Union as issued by the International Accounting Standards Board (IASB) and the International Financial Reporting Interpretations Committee (IFRS IC), and as adopted by the European Union, as such accounting standards may be amended from time to time. |
1.81 |
Improvements means all the right, title, and interest in and to any and all Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of any Party (or its Affiliates or Sublicensees) under or in connection with this Agreement, whether or not patented or patentable, and any and all Patents and other intellectual property rights stemming therefrom. |
1.82 |
IND means an application filed with a Regulatory Authority for authorisation to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., Clinical Trial Application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing. |
1.83 |
Indemnification Claim Notice has the meaning set forth in Section 12.4. |
1.84 |
Indemnified Party has the meaning set forth in Section 12.4. |
1.85 |
Indemnity Technology means [***] |
1.86 |
Information means all knowledge of a technical, scientific, business and other nature, including Know-How, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed. |
1.87 |
Insolvency Event means, with respect to any Party, the occurrence of any of the following events: |
1.87.1 |
the Party files or resolves to file for protection under (i) bankruptcy, (ii) insolvency, (iii) reorganisation (save in the case of a solvent reorganisation), (iv) restructuring (save in the case of a solvent restructuring) or (v) business rescue laws applicable to that Party in any jurisdiction; |
1.87.2 |
the Party makes an assignment for the benefit of creditors; |
1.87.3 |
the Party appoints or suffers appointment of a receiver, administrative receiver, bailiff or trustee or analogous appointment over substantially all of its property; |
1.87.4 |
the Party proposes or implements a scheme of arrangement, company voluntary arrangement or other agreement of composition, compromise or extension of its debts (other than in circumstances where such scheme, arrangement or agreement would have no adverse impact on the rights of any other Party to this Agreement); |
1.87.5 |
the Party proposes or is a party to any dissolution or liquidation or ceases continuation of substantially all of its business; |
1.87.6 |
the Party is subject to any filing of an application or a petition under any (i) bankruptcy, (ii) insolvency, (iii) reorganisation (save in the case of a solvent |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
reorganisation), (iv) restructuring (save in the case of a solvent restructuring) or (v) business rescue laws or has any such application or petition filed against it that, in any such case, is not discharged, in the case of an application or petition filed in the UK, within [***] of the filing thereof or, in the case of an application or petition filed in any other jurisdiction, within [***] of the filing thereof; or |
1.87.7 |
the Party admits in writing its inability generally to meet its obligations as they fall due in the general course (providing always that a request for fulfilment of a specific obligation to be postponed for a specified time shall not amount to an admission that the Party is generally unable to meet its obligations as they fall due). |
1.88 |
IP Power of Attorney means the irrevocable power of attorney granted by Beta to Delta dated of even date herewith, a copy of which is included as a schedule to the Delta IP Licence. |
1.89 |
Joint Controllers has the meaning ascribed to it in Article 26 of the GDPR. |
1.90 |
Joint Steering Committee or JSC has the meaning set forth in Section 2.1. |
1.91 |
Know-How means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions. |
1.92 |
Licensed Ares Background IP has the meaning set out in Section 5.4. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.93 |
Licensed Patent means any of the Beta Patents, Delta Patents and the F-star Patents. |
1.94 |
Licensed Product means any product for use in the Field in the Territory that contains a Subject mAb2, alone or in combination with one (1) or more Other Active Ingredients. Licensed Products in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes, including any improvements thereto shall be deemed to be the same Licensed Product. |
1.95 |
Losses has the meaning set forth in Section 12.1. |
1.96 |
MAA means a Marketing Authorization Application submitted pursuant to the requirements of the FDA, as more fully defined in 21 U.S. CFR§ 314.3 et seq., a Biologics License Application submitted pursuant to the requirements of the FDA, as more fully defined in 21 U.S. CFR § 601 , and any equivalent application submitted in any country in the Territory, including all additions, deletions or supplements thereto, and as any and all such requirements may be amended, or supplanted, at any time. |
1.97 |
mAb2 means an Antibody which contains (a) an Fcab and (b) a Fab. |
1.98 |
mAb2 Target Pairs means the combination of an Fcab Target and a Fab Target of a mAb2. |
1.99 |
Major Markets means [***], and Major Market means any one of them. |
1.100 |
Manufacture, Manufactured and Manufacturing means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labelling, shipping, and holding of any molecule, product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterisation, supply chain, stability testing, quality assurance testing and release, and quality control. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.101 |
[***]. |
1.102 |
Model Clauses has the meaning set forth in Section 10.7. |
1.103 |
Net Sales means, [***] |
(a) |
[***] |
(b) |
[***] |
(c) |
[***] |
(d) |
[***] |
(e) |
[***] |
(f) |
[***] |
(g) |
[***] |
[***]
[***]
[***]
(i) [***]
(ii) [***]
(iii) [***]
(iv) [***]
[***]
1.104 |
Non-Breaching Party has the meaning set forth in Section 13.4. |
1.105 |
Option Exercise Fee means on a Subject mAb²-by-Subject mAb² basis, the payment to be made upon receipt of the invoice regarding a respective Preclinical Program Data Package pursuant to Section 7.1. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.106 |
Option Exercise Fee Payment Date means, on a Preclinical Program Development Plan-by-Preclinical Program Development Plan basis, the date on which the Option Exercise Fee has been paid in accordance with Section 7.1. |
1.107 |
Other Active Ingredient means any component that provides pharmacological activity or other direct therapeutic effect in the Field or that therapeutically affects the structure or any function of the body whereby such component is not covered by a Valid Claim of the F-star Patents. |
1.108 |
Patent Challenge has the meaning set forth in Section 13.5. |
1.109 |
Patent Transfer Instrument has the meaning set forth in Section 13.6.3. |
1.110 |
Patents means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any patent term extensions, supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b), and (c)), (e) any similar patent rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents, and (f) the right to claim priority from any of the foregoing. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.111 |
Pending Claim shall have the meaning set forth in Section 1.140. |
1.112 |
Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organisation, including a government or political subdivision, department or agency of a government. |
1.113 |
Phase I means a human clinical trial of a drug, the principal purpose of which is a preliminary determination of safety, tolerability, dosing, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities from time to time, pursuant to Applicable Law. |
1.114 |
Phase II means a human clinical trial of a drug to be undertaken by way of randomisation, double blind testing or by any other suitable method permitted under Applicable Law, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data from a suitably large group of people that may permit commencement of pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law. |
1.115 |
Phase III means a human clinical trial of a drug on a sufficient number of subjects in an indicated patient population that is prospectively designed to establish that a drug is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such drug, including all tests and studies that are required by the Regulatory Authorities from time to time, pursuant to Applicable Law. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.116 |
Phase IV means a post-approval human clinical study for a drug in a country with respect to any indication for which Regulatory Approval has been received in the country in the relevant Territory. |
1.117 |
Preclinical Program Data Package means, on a Subject mAb2-by-Subject mAb2 basis, that package of data that is set out in the relevant Preclinical Program Development Plan. |
1.118 |
Preclinical Program Data Package Delivery Date means the date on which the relevant Preclinical Program Data Package is delivered pursuant to Section 3.1. |
1.119 |
Preclinical Program Development Plan means the written Development plan to be performed by or on behalf of Delta during the Term. Each Preclinical Program Development Plan shall be based on those set out in Schedule 1.119, and may be amended from time to time in accordance with the terms hereof. |
1.120 |
Product Bundle has the meaning set forth in Section 1.103. |
1.121 |
Registration Costs has the meaning set forth in Section 13.6.3(c). |
1.122 |
Regulatory Approval means, with respect to a country or other jurisdiction in the Territory, any and all approvals, licences, registrations, or authorisations of any Regulatory Authority necessary to commercialise a Subject mAb² or any product containing such Subject mAb² in such country or other jurisdiction, including, where applicable, (a) pricing or reimbursement approval in such country or other jurisdiction, and (b) pre- and post-approval marketing authorisations (including any prerequisite Manufacturing approval or authorisation related thereto). |
1.123 |
Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of any Subject mAb2 or Licensed Products in the Territory. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.124 |
Regulatory Exclusivity means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which Ares or its Affiliates, Distributors or Sublicensees have the exclusive right to market and sell a Subject mAb2 or Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity) provided always that in the case of Regulatory Exclusivity based on orphan drug exclusivity in a country such Regulatory Exclusivity shall be deemed to expire in such country if [***]. |
1.125 |
Relief means any loss, relief, exemption, allowance, deduction, credit or set-off in respect of Tax or relevant to the computation of Tax or to the computation of any income, profit or gains and any right to repayment of Tax. |
1.126 |
[***] |
1.127 |
Senior Officer means, with respect to Delta, its [***], and with respect to Ares, its [***]. |
1.128 |
Subject mAb² means each of the mAb2 set out in Schedule 1.128. |
1.129 |
Subject mAb² Patent means any Patent comprised in the Delta Patents or Ares Patents that specifically claims the composition of matter or the method of use in the Field of a Subject mAb2. |
1.130 |
Subject mAb² Transfer Date shall have the meaning set forth in Section 11.4.8(a). |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
1.131 |
Sublicensee means a Person other than an Affiliate of Ares to which Ares (or its Affiliate) has, pursuant to Section 5.5, granted sublicense rights under any of the rights licenced under this Agreement; provided that Sublicensee shall exclude distributors. |
1.132 |
Target means the target antigen specifically bound by the Fcab or the Fab in an Antibody. |
1.133 |
Tax means all forms of taxation, levy, contribution, duties and withholdings in respect of taxation imposed in the United Kingdom or elsewhere (including, for the avoidance of doubt, National Insurance contributions in the United Kingdom and corresponding obligations elsewhere) and all interest, penalties, charges and fines in respect of any of them. |
1.134 |
Tax Authority means HM Revenue & Customs and any other authority, body or official (whether in the United Kingdom or elsewhere) competent to assess, demand, impose, administer or collect Tax or make any decision or ruling on any matter relating to Tax. |
1.135 |
Term has the meaning set forth in Section 13.2. |
1.136 |
Territory means all countries and territories worldwide. |
1.137 |
Third Party means any Person other than Delta, Beta, F-star, F-star GmbH, Ares and their respective Affiliates. |
1.138 |
Third Party Claims has the meaning set forth in Section 12.1. |
1.139 |
Transaction Documents means this Agreement, the Delta IP Licence and the Delta Support Services Agreement. |
1.140 |
Valid Claim means a claim of (a) an issued and unexpired patent which has not lapsed or been revoked, abandoned or held unenforceable or invalid by a final decision of a court or governmental or supra-governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
disclaimed, denied or admitted to be invalid or unenforceable through reissue, reexamination or disclaimer or otherwise, or (b)(i) any pending bona fide and non-frivolous application submitted in good faith, or (ii) any pending application having a common priority date with a patent described in (a) above that has issued in any other country, in each such case of (i) and (ii), which claim has not been finally abandoned or denied or been held unpatentable by a final decision of a court or governmental or supra-governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal (each of (i) or (ii) above, a Pending Claim). |
1.141 |
VAT means value added tax or similar or equivalent tax in any other jurisdiction levied by reference to added value, consumption or sales. |
1.142 |
Working Group has the meaning set forth in Section 2.3. |
1.143 |
In this Agreement: |
1.143.1 |
all references to a particular article, Section, clause or Schedule shall, unless stated otherwise, be a reference to that article, Section, clause or Schedule in or to this Agreement, in each case as it may be amended from time to time pursuant to this Agreement; |
1.143.2 |
the clause, schedule and paragraph headings are inserted for convenience only and do not affect the interpretation of this Agreement; |
1.143.3 |
unless the context otherwise requires, words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa; |
1.143.4 |
words denoting persons shall include any natural person, corporate or unincorporated body (whether or not having separate legal personality) and that persons personal representatives, successors or permitted assigns; |
1.143.5 |
the Parties acknowledge that certain of the responsibilities of Delta shall be undertaken by Beta, F-star and/or F-star GmbH under the Delta Support |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Services Agreement and accordingly any references in this Agreement to by or on behalf of Delta or similar expressions may include activities undertaken by Beta, F-star and/or F-star GmbH pursuant to the Delta Support Services Agreement, provided that in each case Delta shall remain liable for the performance of the relevant obligations at all times. |
1.143.6 |
the words include, included and including are to be construed without conveying any limitation to the generality of the preceding words; |
1.143.7 |
a reference to a particular statute, statutory provision or subordinate legislation is a reference to it as it is in force from time to time taking account of any amendment or re-enactment and includes any statute, statutory provision or subordinate legislation and any modification or re-enactment of that statute or regulation or any successor or materially equivalent legislation enacted or adopted from time to time in the relevant market; |
1.143.8 |
any reference to notices or consent being sought or given in writing shall require the consent or notice to be signed by an appropriately authorised person and shall not include consents or notices conveyed by email; |
1.143.9 |
the Schedules form part of this Agreement and a reference to this Agreement includes its Schedules, provided that, in the event of any inconsistency or conflict between the operative provisions of this Agreement and any of the Schedules, the operative provisions of this Agreement shall prevail; |
1.143.10 |
references to time are to London time; |
1.143.11 |
references to EUR or are references to Euros, legal tender in the Eurozone, and references to GBP or £ are references to pounds sterling, legal tender in the United Kingdom; and |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
ARTICLE 2
COLLABORATION MANAGEMENT
2.1 |
Joint Steering Committee. From the Effective Date, but not later than [***] after the Effective Date, or earlier, if expressly mutually agreed to in writing by Delta and Ares, until the last Option Exercise Fee Payment Date for respective Subject mAb², Delta and Ares shall establish and maintain a joint steering committee (the Joint Steering Committee or JSC). The JSC shall consist of three (3) representatives from each of Delta and Ares, each with the requisite experience and seniority (in the sole opinion of the appointing party) to enable such person to make decisions on behalf of the relevant Party with respect to the issues falling within the jurisdiction of the JSC. From time to time, Delta and Ares may each substitute one (1) or more of its representatives to the JSC subject to providing prior written confirmation (which may be by email) to the other Party of such substitution. The chairperson of the JSC shall be a representative of Ares. From time to time, Ares may change the representative who will serve as chairperson on written notice to Delta. |
2.2 |
Responsibilities of the JSC. From the Effective Date until the respective Option Exercise Fee Payment Date of the Subject mAb² the JSC shall review the strategy for and oversee the Development of such Subject mAb2 in accordance with the terms of this Agreement. In particular, the JSC shall: |
2.2.1 |
designate a Working Group to meet as soon as reasonably practicable after the Effective Date to discuss, recommend changes to and to finalize the outstanding issues related to the Preclinical Program Development Plans for subsequent approval by the JSC; |
2.2.2 |
review and discuss the conduct of activities under each Preclinical Program Development Plan for each Subject mAb2 until delivery of the relevant Preclinical Program Data Package; |
2.2.3 |
discuss and agree any changes or additions to a Preclinical Program Development Plan; |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
2.2.4 |
discuss and agree whether a Preclinical Program Development Plan should be discontinued for scientific reasons; |
2.2.5 |
agree a policy for publications, presentations or public disclosures related to a Subject mAb2 and consider any proposed publications specifically; |
2.2.6 |
establish Working Groups as provided in Section 2.3 below; and |
2.2.7 |
perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except to the extent that they conflict with any provision of this Agreement. |
2.3 |
Working Groups. The JSC may establish and delegate the operational management of aspects of a Preclinical Program Development Plan to a team of no more than two (2) representatives from each of Ares and Delta (each, a Working Group). It shall be the responsibility of each Working Group to oversee and manage that aspect of the Preclinical Program Development Plan delegated to them. Except as set out in this Section 2.3, each such Working Group shall be constituted and shall operate as the JSC determines; provided that each Working Group shall have equal representation from Ares and Delta (unless otherwise expressly agreed in writing by Ares and Delta). Additional Working Groups may be established on an ad hoc basis for the purposes of a specific project or on such other basis as the JSC may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the JSC. In no event shall the authority of the Working Group exceed the limits of the task delegated to such Working Group and as apply to the JSC. All decisions of a Working Group shall be by consensus. Any disagreement between the designees of Ares and Delta on a Working Group shall be referred to the JSC for resolution. |
2.4 |
Location of Meetings. The JSC shall meet at least once per Calendar Quarter, or as otherwise agreed to in writing by the Parties in order to provide regular updates, in particular shortly upon delivery of a Preclinical Program Data Package, which may require an ad-hoc meeting, with the |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
location of such meetings alternating (unless otherwise agreed by Ares and Delta) between locations designated by Delta and locations designated by Ares. At least [***] of the JSC in each Calendar Year shall be a face-to-face meeting unless the Parties agree otherwise. Any other meeting may be by teleconference or video conference so long as representatives of each Party can hear and be heard in such meeting. |
2.5 |
Conduct of Meetings. The chairperson of the JSC shall be responsible for calling meetings on no less than [***] notice (and the Party which appointed such chairperson shall procure that he or she does so). Delta and Ares shall make any proposals for agenda items and shall provide reasonably appropriate information with respect to such proposed items at least [***] in advance of the applicable meeting; provided that, if the input by the JSC is required urgently, Delta and Ares may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting, such consent not to be unreasonably withheld, conditioned or delayed. An individual designated by the chairperson of the JSC shall prepare and circulate the minutes of each meeting for review and approval of the Parties within [***] after the meeting (and the Party which appointed such person to the JSC shall procure that he or she does so). The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JSC. |
2.6 |
Procedural Rules. The JSC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JSC shall exist whenever there is present at a meeting at least one (1) representative appointed by each of Ares and Delta. Representation by proxy shall be allowed. The JSC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each of Ares and Delta having a single vote irrespective of the number of representatives of such |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. A reasonable and proportionate number of employees or consultants of either Ares or Delta that are not representatives of the Parties on the JSC may attend meetings of the JSC; provided that such attendees (a) shall not vote or otherwise participate in the decision-making process of the JSC, and (b) are bound by obligations of confidentiality and non-disclosure that are substantially similar to those set forth in ARTICLE 9. |
2.7 |
Dispute Resolution. If the JSC cannot, or does not, reach consensus on an issue within the scope of the JSC, including any dispute arising in any Working Group, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to in writing by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within [***] after such issue was first referred to them, then [***]. Excluded Matters shall require the mutual written consent of Ares and Delta through the JSC or the Senior Officers (in each case acting reasonably). |
2.7.1 |
Excluded Matters shall be the following: |
(a) |
Amendments, changes or additions to the procedural rules or standing rules of the JSC; |
(b) |
amendments, changes or additions to any Preclinical Program Development Plan (including any amendments, changes or additions to a Preclinical Program Data Package resulting in a need for additional resources from Delta or extending the project timeline); |
(c) |
any work to be undertaken by Delta in relation to a Subject mAb2 outside the scope of the relevant Preclinical Program Development Plan, including any work to be undertaken by Delta after the delivery of the Preclinical Program Data Package; and |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(d) |
any decision that would result in any material increase in Deltas costs of performing its obligations under a Preclinical Program Development Plan provided always that an increase in Deltas costs, when aggregated with other increases that occur in relation to each Preclinical Program Development Plan, of [***] shall be material. |
2.8 |
Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The JSC does not have the power to amend, modify, or waive compliance with this Agreement, which may only be amended or modified as provided in Section 14.9.3 or compliance with which may only be waived as provided in Section 14.12. |
2.9 |
Alliance Manager. Delta and Ares shall each appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of the JSC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an Alliance Manager). Delta and Ares may each replace its Alliance Manager at any time by notice in writing to the other Party. |
2.10 |
Interactions Between the JSC and Internal Teams. The Parties recognise that each Party possesses an internal structure (including various committees, teams and review boards) that will be involved in administering such Partys activities under this Agreement. Nothing contained in this ARTICLE 2 shall prevent a Party from making routine day-to-day decisions relating to the conduct of those activities for which it has a performance or other obligations hereunder, in each case in a manner consistent with the then-current applicable plan and the terms and conditions of this Agreement, provided always that nothing in this Section 2.10 shall operate so as to relieve a Party from its obligations under this Agreement. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
2.11 |
Expenses. As between the Parties, each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JSC or other Working Group. |
ARTICLE 3
PRECLINICAL DEVELOPMENT PROGRAMS
3.1 |
Preclinical Program Development Plans. Following the Effective Date, Delta and Ares shall use, and shall procure that any Person to whom it sub-contracts its obligations pursuant to Section 3.5 uses, Commercially Reasonable Efforts to carry out its responsibilities under each Preclinical Program Development Plan and to deliver Preclinical Program Data Packages which have been prepared with due care and attention, which accurately reflect the data generated by the investigations carried out for the purposes of each Preclinical Program Development Plan and which are not misleading in any respect. Each Preclinical Program Development Plan includes a description of the required Preclinical Program Data Package for the relevant Subject mAb2. The Preclinical Program Development Plans set out in Schedule 1.118 shall be effective from the Effective Date until amended and updated by the Parties from time to time. Any disputes related to preparation of or amendment to a Preclinical Program Development Plan shall be handled in accordance with Section 2.7. |
3.2 |
Ares Right to Continue Development of a Subject mAb2. Within a period of [***] after delivery of the respective Preclinical Program Data Package regarding a Subject mAb², Ares may decide in its sole discretion, (i) by sending written notice to Delta to continue Development of the relevant Subject mAb2 and to pay the respective Option Exercise Fee in |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
accordance with Section 7.1 regarding such Subject mAb²; or (ii) to terminate this Agreement in respect of such Subject mAb² in accordance with Section 13.3. provided always that failure by Ares to provide a notice pursuant to (i) shall be deemed a termination pursuant to (ii). It is hereby acknowledged and agreed by all Parties that as of the Effective Date Delta has delivered the Preclinical Program Data Package in respect of Subject mAb² [***] and that the Option Exercise Fee shall become due and payable within [***] after receipt of a respective invoice from Delta. |
3.3 |
Manufacturing of Subject mAb². From the Effective Date until the respective Option Exercise Fee Payment Date, Delta shall be responsible for the manufacture of the respective Subject mAb² necessary for the conduct of the Preclinical Program Development Plan. All internal and external costs associated with the carrying out of the production of the respective Subject mAb² described in this Section are included in the research and development funding to be paid pursuant to Section 7.2. |
3.4 |
Diligence. |
3.4.1 |
Delta shall use, and shall procure that any Person to whom it sub-contracts its obligations pursuant to Section 3.5 uses, its Commercially Reasonable Efforts to carry out each Preclinical Program Development Plan and to deliver the relevant Preclinical Program Data Package as soon as reasonably practicable. Delta shall provide Ares with [***] written reports describing the progress of its activities under each Preclinical Program Development Plan. |
3.4.2 |
The Parties acknowledge and agree that, notwithstanding that reasonable efforts have been taken to set out in each Preclinical Program Development Plan appropriate details of the work to be undertaken in respect of each Subject mAb², the Preclinical Program Development Plans do not set out every action, obligation or step which an F-star Party may need to take or fulfil in order to give effect to the objectives, or to fulfil the requirements, |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
of each Preclinical Program Development Plan. The Parties accordingly agree that: |
(a) |
each Preclinical Program Development Plan shall be deemed to include (and each Party shall use its Commercially Reasonable Efforts to carry out) any additional actions, obligations or steps which could reasonably have been expected to have been required of that F-star Party in order to carry out the work set out in that Preclinical Program Development Plan (for the avoidance of doubt, without any further payment being required to Delta by Ares); and |
(b) |
no Party shall unreasonably refuse consent to any amendments, changes or additions to a Preclinical Program Development Plan that would not extend either the costs or timeline of that Preclinical Program Development Plan in any material respect. |
3.4.3 |
The Parties acknowledge and agree that no outcome or success of any Development carried out pursuant to this Agreement is or can be assured and that the failure of a Subject mAb² to achieve the results desired of it will not in and of itself constitute a breach or default of any obligation in this Agreement. |
3.5 |
Subcontracting. From the Effective Date until the respective Option Exercise Fee Payment Date each Party shall have the right to enter into subcontracts with its Affiliates and to subcontract Approved Subcontractors for the purposes of carrying out its obligations under this Agreement; provided that (i) such subcontracts shall be in writing and consistent with the terms and conditions of this Agreement; (ii) such Approved Subcontractors and Affiliates agree in writing to be subject to the applicable terms and conditions of this Agreement, including the requirements under Section 3.4.1 and the confidentiality provisions of ARTICLE 9; (iii) the subcontracting Party provides in the subcontract that all intellectual property that may arise as a result of the work performed |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
under the subcontract is either owned directly by or assigned to the subcontracting Party by the Approved Subcontractor or Affiliate, as required by ARTICLE 8; (iv) upon request, the Party which has sub-contracted its obligations shall provide any information about, and use reasonable efforts to procure access to the premises, records and personnel of, the relevant Approved Subcontractor or Affiliate which the requesting Party may reasonably require in order to monitor compliance with the terms of this Agreement or to satisfy any Applicable Law or audit requirement; and (v) notwithstanding such subcontracting, the subcontracting Party shall remain liable for the performance of such obligations. Ares agrees that the subcontractors listed in Schedule 3.5 are Approved Subcontractors and the terms of the subcontract are approved. Notwithstanding the foregoing it is agreed and understood that following the Option Exercise Fee Payment Date in respect of any Subject mAb², the foregoing sentence shall no longer be applicable to Ares and Ares shall be free to enter into subcontracts with respect to the Development, Manufacturing and Commercialisation of such Subject mAb2 with any person in its sole discretion. |
3.6 |
Records. Delta shall, and shall ensure that its Affiliates and Approved Subcontractors, maintain records of all matters relating to the subject matter of this Agreement and the work carried out under each Preclinical Program Development Plan: |
3.6.1 |
in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes; |
3.6.2 |
in compliance with Applicable Law and regulatory guidance; and |
3.6.3 |
which are complete and accurate and properly reflect all work done and results achieved in the performance of its obligations under each Preclinical Program Development Plan, and which, after the Effective Date, shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Such records shall be retained by each Party and its Affiliates and Approved Subcontractors for at least [***] after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Upon request, Delta shall provide, and shall procure that its Affiliates and Approved Subcontractors provide, copies of the records it has maintained pursuant to this Section 3.6 to Ares.
ARTICLE 4
COMMERCIALISATION OF SUBJECT MAB2 AND LICENSED PRODUCTS
4.1 |
In General. On a Preclinical Program-by-Preclinical Program basis, following the Option Exercise Fee Payment Date and for the remainder of the Term with respect to such Subject mAb2 and the relevant Licensed Product as between the Parties, Ares shall have the exclusive right to Develop, Manufacture and Commercialize (and shall control all aspects of such Development and Commercialization), itself or through its Affiliates or Sublicensees, Licensed Products in the Field and in the Territory at its own cost and expense (except as otherwise expressly set forth herein). |
4.2 |
Diligence. Subject to Deltas fulfilment of its material obligations under this Agreement, Ares shall on a Subject mAb²-by-Subject mAb² basis use Commercially Reasonable Efforts to (a) Develop [***] and (b) Commercialize [***]; provided that, such Development and Commercialization obligations shall be expressly conditioned upon [***]. [***] |
4.3 |
Reporting. On a Licensed Product-by-Licensed Product basis, following delivery of the relevant Preclinical Program Data Package for a particular Subject mAb2 and for the remainder of the Term in respect of such Licensed Product containing such Subject mAb2 and for the remainder of the Royalty Term with respect to such Fab Target, [***]. All information and reports provided to Delta pursuant to this Section 4.3 shall be treated as Confidential Information of Ares hereunder. Notwithstanding the foregoing, Ares obligation to provide reports under this Section 4.3 shall |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
expire on a Subject mAb2 and Licensed Product basis: (i) with respect to Development, upon receipt of Regulatory Approval for such Subject mAb2 and/or Licensed Product in [***], and (ii) with respect to Commercialization of the relevant Licensed Product, upon the expiry of Ares obligation to make payments in respect of the relevant Licensed Product hereunder. |
4.4 |
Booking of Sales; Distribution. Ares shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products in the Territory and to perform or cause to be performed all related services. Ares shall handle all returns, recalls, or withdrawals, order processing, invoicing, collection, distribution, and inventory management with respect to the Licensed Products in the Territory. |
4.5 |
Product Trademarks. As between the Parties, Ares shall have the sole right to determine and own the trademarks to be used with respect to the Exploitation of the Licensed Products on a worldwide basis. |
4.6 |
Supply of Licensed Products and the relevant Subject mAb2. On a Licensed Product-by-Licensed Product basis, following the Option Exercise Fee Payment Date and for the remainder of the Term, Ares shall have the sole right, at its expense, to Manufacture (or have Manufactured) pursuant to Section 5.10 and supply the relevant Subject mAb2 and Licensed Products for commercial sale in the Territory by Ares and its Affiliates and Sublicensees. |
ARTICLE 5
GRANT OF RIGHTS AND EXCLUSIVITY
5.1 |
mAb2 Exclusivity. During the Term of this Agreement, the F-star Parties shall not, and shall procure that each of their respective Affiliates shall not (other than pursuant to the terms of this Agreement): |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.1.1 |
for itself or themselves, Develop, Commercialise or Manufacture any [***] in any country in the Territory; and |
5.1.2 |
license, authorise, appoint, or otherwise enable any Third Party to, directly or indirectly, Develop, Commercialise or Manufacture any [***] in any country in the Territory; |
provided always that, following [***], the restrictions set out in this Section 5.1 shall not apply to any [***] that otherwise meets all of the criteria set forth above [***] (where a Change in Control shall mean the acquisition by a person or group of persons acting together of control (as defined in the definition of Affiliate) of the relevant entity by way of share acquisition, merger, agreement or otherwise or the sale of all or substantially all of the assets to which this Agreement relates to such person).
5.2 |
Subject to Section 5.1, the F-star Parties, with regard to Ares, reserve all rights to Develop, Commercialise or Manufacture (i) any Antibody containing any Fcab for use with any Fab Target other than where such Fcab Target and Fab Target comprise an Accepted mAb2 Target Pair and (ii) any Fcab as a stand-alone product or service that is not incorporated into an Antibody. |
5.3 |
Grants to Ares. Subject to Section 5.12, each of Beta and Delta hereby grant to Ares, on a Subject mAb2-by-Subject mAb2 basis an exclusive (even as to the F-star Parties) worldwide, royalty-bearing right and license, with the right to grant sublicenses in accordance with Section 5.5, under the F-star IP, Beta IP and Delta IP, (i) to Exploit such Subject mAb2 and (ii) to incorporate such Subject mAb2 in Licensed Products in each case, in the Field in the Territory; provided that Beta and Delta reserve from such licenses the rights, on a Subject mAb2-by-Subject mAb2 basis, to carry out each Preclinical Program Development Plan in accordance with the provisions of this Agreement. |
5.4 |
Grants by Ares to Delta. Ares hereby grants to Delta, on a Subject mAb2-by-Subject mAb2 basis, [***], a royalty-free non-exclusive licence, |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
with the right to grant sublicences to Affiliates and Approved Subcontractors, under the Licensed Ares Background IP, solely to conduct the activities under any Preclinical Program Development in the Territory. Licensed Ares Background IP shall comprise: |
(a) |
any Ares Background IP that is disclosed to an F-star Party in the meetings of JSC or Working Group as recorded in the relevant minutes (provided that such minutes have been approved by Ares), save where the Parties expressly agree at such JSC or Working Group meeting that particular Ares Background IP shall be dealt with under Section 5.4(c) below; |
(b) |
any Ares Background IP that Ares discloses in writing (including in any request from Ares to undertake a particular activity) to an F-star Party in relation to the implementation of a Preclinical Program Development Plan, save where the Parties expressly agree that the particular Ares Background IP shall be dealt with under Section 5.4(c) below; and |
(c) |
any Ares Background IP that the Parties agree in writing would be useful or necessary to conduct the activities under any Preclinical Program Development Plan subject to the Parties agreeing the terms of a licence of such Ares Background IP to Delta, solely to allow Delta to conduct the activities under such Preclinical Program Development Plan. If the Parties cannot agree the terms of a licence agreement, and provided that the Parties have sought to negotiate the terms of such licence agreement in good faith, then the F-star Parties shall not be in breach of any obligation to use Commercially Reasonable Efforts to undertake a Preclinical Program Development Plan if and to the extent that use of such Ares Background IP is necessary in order for the F-star Parties to comply with their obligations to undertake such a Preclinical Program Development Plan and there is no alternative technology reasonably available. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.5 |
Sublicenses. |
5.5.1 |
Ares shall have the right to grant sublicenses, through multiple tiers of sublicenses, under the licenses granted in Section 5.3, to Sublicensees and Distributors; provided that any such sublicenses shall (i) be in writing, (ii) be consistent with the terms and conditions of this Agreement, and (iii) require the applicable Sublicensee or Distributor to comply with all applicable terms of this Agreement. |
5.5.2 |
Ares shall be responsible for the performance of any Sublicensee or Distributor as if such Sublicensee or Distributor were Ares hereunder. Each sublicense granted by Ares to any rights licensed or granted will terminate immediately upon the termination of the license from Delta to Ares with respect to such rights. |
5.6 |
Technology Transfer. As soon as reasonably practicable after the Effective Date with respect to [***] and/or the Preclinical Program Data Package Delivery Date with respect to the other Subject mAb2, but in no event later than [***] following the relevant Option Exercise Fee Payment Date, (i) Delta will transfer to Ares at Deltas cost and expense, all Delta Know-How, (ii) Beta will transfer to Ares at Betas cost and expense, all Beta Know-How (except for Know-How relating to the manufacture of the Subject mAb² which are subject to Section 5.8). |
5.7 |
F-star Parties Aggregate FTE Limits. In respect of each Subject mAb2, the F-star Parties aggregate responsibility to provide any advice, transfer or support to Ares after the relevant Preclinical Program Data Package Delivery Date shall be limited, on a Subject mAb2-by-Subject mAb2 basis to (i) the provision of [***] (ii) incurring no more than [***] and (iii) shall only continue until the earlier of [***] or [***]. The F-star Parties shall have no obligation to provide any support beyond this limit unless Ares and the relevant F-star Party agree the terms for the provision of such support. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
5.8 |
Manufacturing Technology Transfer. Following the Option Exercise Fee Payment Date in respect of a particular Subject mAb2, the F-star Parties shall transfer to Ares or its designee the manufacturing process that the F-star Parties have used in the manufacture of the relevant Subject mAb2 to Ares. Such transfer shall, to the extent that the F-star Parties have the legal right to do so, include the relevant cell lines and assays used for the expression and characterization of the relevant Subject mAb2 and the know-how that is necessary for the expression and characterization of the relevant Subject mAb2. Such Manufacturing technology transfer shall take place as soon as reasonably practicable after the Option Exercise Fee Payment Date for the particular Subject mAb2, but in no event later than [***] following the relevant Option Exercise Fee Payment Date. Notwithstanding the foregoing, nothing shall require Delta to create new Intellectual Property, undertake any additional manufacturing activities or to undertake any activity not specified in the relevant Preclinical Program Work Plan other than the transfer of the materials and Know-How that are in Deltas possession or Control that are relevant to the Manufacture of such Subject mAb2. The costs and expenses incurred by Delta associated with such technology transfer shall, subject to Section 5.8, be borne by Delta and thereafter shall be borne by Ares. All other costs and expenses associated with performing the Manufacturing technology transfer shall be borne by Ares. Without limiting the generality of the foregoing, upon Ares request, Delta shall, to the extent that (i) it is legally permitted and (ii) such agreement relates solely to the relevant Subject mAb2, assign to Ares those agreements that relate exclusively to the manufacture of the Subject mAb² or a Licensed Product, if any, provided that each Party shall meet its own costs in procuring such assignment. |
5.9 |
Procedures for Technology Transfer. The technology transfers set forth in Section 5.6 and Section 5.8 shall occur in an orderly fashion and in a manner such that the confidentiality of the transferred F-star Parties |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Know-How, Subject mAb² is preserved in all material respects. Notwithstanding anything of the aforesaid Delta shall, provided that the F-star Aggregate Support Limit has not been and is not thereby exceeded in relation to the relevant Subject mAb2, Delta shall provide such further reasonable consultation and assistance to Ares as reasonably requested by Ares in order to perfect the technology transfers set forth in Section 5.6 and 5.8 upon their completion. The Parties agree that Delta shall, provided that the F-star Aggregate Support Limit has not been and is not thereby exceeded, provide such further reasonable consultation and assistance to Ares free of charge until the later of (a) [***] (b) or [***]. |
5.10 |
Clinical and Commercial Manufacturing. Ares shall have the exclusive right to manufacture the Subject mAb² and Licensed Product itself or through one or more Affiliates or Sublicensees or other Third Parties selected by Ares. |
5.11 |
Distributorships. Ares and its Affiliates shall have the right, in their sole discretion, to appoint any Third Parties, in the Territory or in any country or other jurisdiction of the Territory, to distribute, market, and sell the Licensed Products, in circumstances where the Person purchases, in finished form, Licensed Products from Ares or its Affiliates or a Sublicensee of either of them. Where Ares or its Affiliates appoints such a Third Party, that Person shall be a Distributor for purposes of this Agreement and Net Sales from such Distributors shall include all of the amounts received from and exclude all of the amounts paid to such Third Parties ([***]) in consideration for the sale of any Licensed Products. For clarity, if Ares grants to a Third Party any rights under applicable Intellectual Property to make, use, sell, offer for sale or import a Licensed Product, then such Third Party shall be a Sublicensee and not a Distributor. |
5.12 |
No Implied Rights. Except as expressly provided herein, Delta grants no other right or licence, including any rights or licences to the Delta IP, Beta IP or F-star IP, or any other Patent or intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel, or |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
otherwise. Except as expressly provided herein, Ares grants no other right or licence, including any rights or licences to the Ares Background IP, or any other Patent or intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel or otherwise. |
5.13 |
Registration and Confirmatory Patent License. Each Party shall have the right to have itself registered as licensee (pursuant to the licences granted under this Agreement) at any Patent offices and other authorities in the Territory where such registration is required or is legally possible. Each Party shall, at the request and cost of the other Party, promptly enter into confirmatory license agreements in the form or substantially the form reasonably requested by the requesting Party, and otherwise provide any necessary support, for purposes of recording the licences granted under this Agreement with such Patent offices and other authorities in the Territory as the requesting Party considers appropriate. |
5.14 |
Financial Obligations. Subject to the terms of the Delta IP Licence, as between Delta and Ares, all financial obligations of Delta, including royalties, due from Delta to Third Parties for the F-star IP, Beta IP and/or Delta IP are the sole responsibility of Delta, and all financial obligations of Ares, including royalties, due from Ares to Third Parties for the Licensed Ares Background IP are the sole responsibility of Ares. |
5.15 |
Ares shall abide, and will cause all its Affiliates and applicable Sublicensees to abide, by all requirements of the Delta IP Licence in all respects, to the extent applicable to Ares, its Affiliates, and applicable Sublicensees as sublicensees thereunder. |
5.16 |
In-Licence Agreements. |
5.16.1 |
Maintenance of F-star In-Licences. F-star shall timely pay in full all amounts required to be paid by F-star, and timely perform in full all obligations required to be performed by F-star, under all F-star In-Licences. Without the prior express written consent of Ares, F-star shall not (and shall take no action or make no omission to) breach, modify or waive any |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
provision of any F-star In-Licence that could impair the value of the licenses granted to Ares herein, or to terminate or have terminated or allow to expire any F-star In-Licence. In the event that the licensor of any F-star In-Licence gives notice to terminate or terminates such F-star In-Licence, or if such F-star In-Licence is due to expire, (an Old F-star In-Licence), then F-star shall notify Ares, and |
(a) |
if such F-star In-Licence is necessary for F-star or Beta to comply with their obligations under and with respect to any Preclinical Program Development Plan and deliver any outstanding Preclinical Program Data Package then F-star shall use its Commercially Reasonable Efforts to avoid such termination, and to maintain or renew such F-star In-Licence, or to enter into a new F-star In-Licence of sufficient scope to replicate the rights under the Old F-star In-Licence sub-licensed to Delta pursuant to the Delta IP Licence; and |
(b) |
otherwise, upon the written request of Ares and at Ares cost, F-star shall use its Commercially Reasonable Efforts to avoid such termination, and to either renew such F-star In-Licence or to assist Ares in obtaining the grant of a direct in-licence to Ares, Delta or another Ares entity specified by Ares, of sufficient scope to replicate the rights under the Old F-star In-Licence sub-licensed to Delta pursuant to the Delta IP Licence. |
5.16.2 |
Maintenance of Beta In-Licences. Beta shall timely pay in full all amounts required to be paid by Beta, and timely perform in full all obligations required to be performed by Beta, under all Beta In-Licences. Without the prior express written consent of Ares, Beta shall not (and shall take no action or make no omission to) breach, modify or waive any provision of any Beta In-Licence that could impair the value of the licenses to Ares herein, or to terminate or have terminated or allow to expire any Beta In-Licence. In the event that the licensor of any Beta In-Licence gives notice to terminate or terminates such Beta In-Licence, or if such Beta In-Licence is due to expire, (an Old Beta In-Licence), then Beta shall notify Ares, and |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(a) |
if such Beta In-Licence is necessary for F-star or Beta to comply with their obligations under and with respect to any Preclinical Program Development Plan and deliver any outstanding Preclinical Program Data Package then Beta shall use its Commercially Reasonable Efforts to avoid such termination and to maintain or renew such Beta In-Licence, or to enter into a new Beta In-Licence of sufficient scope to replicate the rights under the Old Beta In-Licence sub-licensed to Delta pursuant to the Delta IP Licence; and |
(b) |
otherwise, upon the written request of Ares and at Ares cost, Beta shall use its Commercially Reasonable Efforts to avoid such termination, and to either renew such Beta In-Licence or to assist Ares in obtaining the grant of a direct in-licence to Ares, Delta or another Ares entity specified by Ares, of sufficient scope to replicate the rights under the Old Beta In-Licence sub-licensed to Delta pursuant to the Delta IP Licence. |
ARTICLE 6
REGULATORY MATTERS
6.1 |
Regulatory Filings. As between Ares and the F-star Parties, Ares shall own and maintain all regulatory filings and Regulatory Approvals for the Subject mAb² and Licensed Product, including all INDs and MAAs. |
6.2 |
Communications with Authorities. Ares (or one of its Affiliates or Sublicensees) shall be responsible, and act as the sole point of contact, for communications with Regulatory Authorities in connection with the Development, Commercialization, and Manufacturing of Licensed Product. Following the Effective Date, an F-star Party shall not initiate, with respect to Subject mAb² or Licensed Product, any meetings or contact with Regulatory Authorities without Aress prior written consent. To the |
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extent an F-star Party receives any written or oral communication from any Regulatory Authority relating to the Subject mAb² or Licensed Product, the respective F-star Party shall (a) refer such Regulatory Authority to Ares, and (b) as soon as reasonably practicable (but in any event within twenty-four (24) hours), notify Ares and provide Ares with a copy of any written communication received by the respective F-star Party or, if applicable, complete and accurate minutes of such oral communication. |
6.3 |
Support in Regulatory Matters. During the Term each F-star Party shall, provided the F-star Aggregate Support Limit has not been and is not thereby exceeded, free-of charge and subject to the reasonable request of Ares make its representatives that are knowledgeable regarding the F-star IP, Subject mAb² or a Licensed Product available to Ares for regulatory explanations, advice and on-site support, that may reasonably be required by, and not otherwise available to, Ares relating regulatory matters (including preparation and filing for any INDs). |
6.4 |
Adverse Event Reporting. The Parties agree to comply with any and all Applicable Laws that are applicable as of the Effective Date and thereafter during the Term in connection with Licensed Product safety data collection and reporting. If an F-star Party has or receives any information regarding any Adverse Event which relates to the use of Licensed Product, then such F-star Party shall provide Ares with all such information within such reasonable timelines which enable Ares to comply with all Applicable Laws and relevant regulations and requirements. The information exchanged between the Parties pursuant to this Section 6.4 shall be transmitted to Ares by e-mail, facsimile or overnight courier to the following address: |
[***]
6.5 |
Recalls. Ares shall have the sole right to determine whether and how to implement a recall or other market withdrawal of the Licensed Product. |
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ARTICLE 7
PAYMENTS AND RECORDS
7.1 |
Option Exercise Fee. Within [***] upon receipt of a respective invoice from Delta regarding a Preclinical Program Data Package (such invoice not to be issued until Ares has notified Delta of its intention to continue Development of the relevant Subject mAb2 pursuant to Section 3.2), Ares shall, provided that it has made the election to continue Development of the relevant Subject mAb2 pursuant to Section 3.2, pay Delta the sum listed for such Subject mAb² in Schedule 7.1 (subject to any withholding tax obligations set forth in Section 7.12). |
7.2 |
Research and Development Costs. In consideration of Delta meeting all costs of implementing its activities and obligations under each Preclinical Program Development Plan (including all internal and out-of-pocket costs and, for the avoidance of doubt, whether or not such costs exceed any sums paid to Ares by Delta pursuant to this Agreement) during the Term, Ares shall pay to Delta non-refundable (except as set out below) [***] payments, in advance [***] [***] commencing on 1 July 2019 and thereafter as set out in Schedule 7.2, such payments being due on the first (1st) day of the [***] to which they relate and to be paid within [***] of receipt of an invoice from Delta; provided that the amount payable in respect of the final [***] of the Term shall be pro-rated on a calendar day basis by reference to the period from the first day of that [***] to the second (2nd) anniversary of the Effective Date. By way of illustration only, Schedule 7.2 sets out how such [***] payments would be calculated if the Effective Date of the Agreement was 1 July 2019. Within [***] after delivery of the Preclinical Program Data Package or as the case may be after termination, Delta shall send a report detailing the actual Development costs incurred under the Preclinical Program Development Plan and compare such amounts to the amounts set forth under Schedule 7.2. Within [***], Ares and Delta shall conduct a reconciliation process to align the prepayments against the actual spend. Should the actual cost incurred be more than [***] below the budgeted amount under the |
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Preclinical Program Development Plan as set out in Schedule 7.2, Delta will repay this excess amount within [***] after receiving this invoice. Should the actual cost incurred be more than [***] above the budgeted amount under the Preclinical Program Development Plan, Ares will compensate Delta for such excess Development Expenses within [***] of having received an invoice, if they have been approved by the JSC during the Term. |
7.3 |
Milestone Payments. In partial consideration of the rights granted by Delta to Ares hereunder and subject to the terms and conditions set forth in this Agreement, Ares shall pay to Delta the non-refundable, non-creditable milestone payments set out in Schedule 7.3 with respect to each Licensed Product within [***] after the achievement by Ares, its Affiliate or a Sublicensee of Ares of the corresponding milestone event and receipt of a respective invoice from Delta. Each milestone payment in Schedule 7.3 with respect to each Licensed Product shall be payable only upon the achievement of such milestone event by the relevant Subject mAb2 or corresponding Licensed Product to achieve such milestone event and no amounts shall be due for subsequent or repeated achievements of such milestone events by such Subject mAb2. |
7.4 |
Royalty Payments for Licensed Products. As further consideration for Deltas grant of the rights and licenses to Ares hereunder, Ares shall, during the Royalty Term, pay to Delta a non-refundable royalty on aggregate annual Net Sales of the Licensed Product for each Calendar Year, on a Licensed Product-by-Licensed Product and a country-by-country basis at a rate of [***] of Net Sales. For purposes of determining whether a royalty threshold has been attained, only Net Sales that are subject to a royalty payment shall be included in the total amount of Net Sales and any Net Sales that are not subject to a royalty payment shall be excluded (e.g. it would not include Net Sales for a certain Licensed Product in a certain country if the Royalty Term has ended with respect to such Licensed Product in such country). In addition, in no event shall the mere manufacture (i.e., absent a sale) of the Licensed Product give rise to |
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a royalty obligation. For clarity, Aress obligation to pay royalties to Delta under this Section 7.4 is imposed only once with respect to the same unit of Licensed Product regardless of the number of Delta Patents pertaining thereto. Option Exercise Fees, milestone payments, research and Development payments and other payments pursuant to this Agreement (including under Sections 7.1, 7.2, and 7.3) are not an advance or otherwise creditable against royalties, and vice versa. |
7.5 |
Compulsory License. In the event that Delta or Ares receives a request for a Compulsory License anywhere in the world, it shall promptly notify the other Party. If any Third Party obtains a Compulsory License in any country of the Territory, then Delta or Ares (whoever has first notice) shall promptly notify the other Party. For the avoidance of doubt, for purposes of calculating the royalties due to Delta under Section 7.4 with respect to sales of the Licensed Product by any compulsory licensee, Ares obligations to make royalty payments to Delta shall be adjusted to match any lower royalty rate payable by such compulsory licensee to Ares under the Compulsory License. In addition, should Ares grant a sublicense to a Third Party in any country of the Territory to avoid the imposition of such a Compulsory License, the royalty rate payable under Section 7.4 to Delta shall also be adjusted to match any lower royalty rate payable by such Sublicensee for such country under such sublicense. |
7.6 |
Royalty reductions. |
7.6.1 |
During the Royalty Term in a country, the royalty rates set forth in Section 7.4 will be reduced by [***], on a Licensed Product-by-Licensed Product and country-by-country basis, if and only as long as the following conditions are met with respect to the specific Licensed Product and the specific country at issue: [***]. |
7.6.2 |
If a Licensed Product cannot be sold in one or more countries without such sale infringing a Patent of a Third Party which Patent specifically claims the sequence of the relevant Subject mAb2 (Affected Sales), and Ares |
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wishes to enter into a license agreement with such Third Party with respect to such Affected Sales (Third Party License Agreement), then Ares shall notify Delta and the Parties shall discuss in good faith whether such Third Party Patent is, in fact, infringed by the manufacture or use of the relevant Subject mAb2. If Ares thereafter enters into a Third Party License Agreement, Ares will be entitled to deduct [***] of the Third Party Royalties paid by Ares to such Third Party from any amounts payable to Delta pursuant to Section 7.4 on account of Net Sales that would be Affected Sales absent the Third Party License Agreement, provided always that in no Calendar Quarter shall the royalties payable to Delta after such deduction be less than [***] of the rate set out in Section 7.4. For purposes hereof, Third Party Royalties means running royalties due and actually paid under the Third Party License Agreement on account of Net Sales that would be Affected Sales absent the Third Party License Agreement, but only to the extent such royalties are attributable to the license under the Third Partys relevant Patents as described above (and not any other rights or benefits under such Third Party Agreement). In no event shall Ares be entitled to deduct any portion of any other payments under such Third Party License. In no event shall Ares be entitled to make any deductions pursuant to this Section 7.6.2 from royalties due to Delta that are based on the reduced royalty rate pursuant to Section 7.6.1. |
7.6.3 |
Notwithstanding anything to the contrary herein, in no event shall any amount payable to Delta under this Agreement be reduced (whether pursuant to Section 7.6.1 or 7.6.2 or any other provision or combination of provisions of this Agreement) to less than [***] of Net Sales. In the event that Ares is not able to deduct the full amount of the permitted deduction from the amount due to Delta due to the [***], Ares shall be entitled to deduct any undeducted excess amount from subsequent amounts owed to Delta (subject always to Delta receiving a minimum royalty of[***]). |
7.7 |
Timing of Payment. Royalties payable under Section 7.4 shall accrue at the time the invoice for the sale of the Licensed Product is delivered. Royalty obligations that have accrued during a particular Calendar Quarter |
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shall be paid, on a Calendar Quarter basis, within [***] after the end of the applicable Calendar Quarter, concurrently with the submission of the royalty report for the Calendar Quarter during which the royalty obligation accrued. |
7.8 |
Mode of Payment and Currency. All payments payable by Ares to Delta under this Agreement shall be made from Germany to the UK, without setoff, by electronic transfer depositing Euro in the requisite amount to such bank account as Delta may from time to time designate by written notice to Ares. With respect to sales (and other amounts) not denominated in Euro, Merck shall convert such amounts in foreign currency into Euro by using the then current and reasonable standard exchange rate methodology as consistently applied to its external reporting generally. Based on the resulting amounts in Euro, the then applicable royalties shall be calculated. Invoices submitted by Delta shall be addressed to: |
[***]
With copies to:
[***]
and
[***]
and shall state a purchase order number (which shall be provided by Ares to Delta within no more than [***] following the Effective Date), the Ares contact person (who shall be the Ares Alliance Manager) and VAT registration number CHE-116.289.574, and shall include information in respect of each of the mandatory fields set out in Schedule 7.4.
7.9 |
Royalty Reports and Records Retention. Within [***] after the end of each Calendar Quarter during which the Licensed Products have been sold, Ares shall deliver to Delta, together with the applicable royalty payment due, a written report, on a Licensed Product-by-Licensed Product and a country-by-country basis, setting forth (i) the total number of Licensed Products sold, (ii) gross amounts invoiced, aggregate Net Sales, |
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and the calculation of Net Sales, including any deductions made, (iii) royalties payable and the calculation thereof, and (iv) applicable exchange rates used. Such reports shall be deemed Confidential Information of both Parties subject to the obligations of ARTICLE 9 of this Agreement. For at least [***] after submission of each such report, Ares shall keep (and shall ensure that its Affiliates and Sublicensees shall keep) complete and accurate records of all relevant data in sufficient detail to confirm the accuracy of the royalty calculations and other information to be reported hereunder. |
7.10 |
Audits. |
7.10.1 |
During the Royalty Term and for [***] thereafter, upon the written request of Delta, and not more than once in each Calendar Year, Ares shall permit, and shall cause its Affiliates and Sublicensees to permit, an independent certified public accounting firm of nationally recognized standing selected by Delta, and reasonably acceptable to Ares or such Affiliate or Sublicensee, to have access to and to review, during normal business hours upon reasonable prior written notice, the applicable records of Ares and its Affiliates or Sublicensees to verify the accuracy of the royalty reports and payments under this ARTICLE 7. Such review may cover the records for sales made in, or otherwise pertaining to, any Calendar Year ending not more than [***] prior to the date of such request. The accounting firm shall disclose to Delta and Ares only whether the royalty reports and payments made are correct or incorrect, the basis for its findings, and the specific details concerning any discrepancies. No other information shall be provided to Delta. |
7.10.2 |
If such accounting firm concludes that additional royalties were owed during such period, and Ares does not in good faith dispute such calculation, Ares shall pay the additional royalties within [***] after the date Delta delivers to Ares such accounting firms written report. If such accounting firm concludes that an overpayment was made, and Delta does not in good faith dispute such calculation, such overpayment shall be fully creditable |
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against amounts payable in subsequent payment periods. If Ares disagrees with Deltas accountants calculation, it may retain, at its own cost, its own independent certified public accounting firm of recognized standing and reasonably acceptable to Delta, to conduct a review, and if such firm concurs with the other accounting firm, Ares shall make the required payment within [***] after the date Ares receives the report of its accounting firm. If Aress accounting firm does not concur, Ares and Delta shall meet and negotiate in good faith a resolution of the discrepancies between the two firms, and if they cannot agree, each Party may pursue other remedies. Delta shall pay for the cost of its audit, unless Ares has underpaid Delta by [***], in which case Ares shall pay for the costs of the audit. |
7.10.3 |
Each Party shall treat all information that it receives under this Section 7.10 in accordance with the confidentiality provisions of ARTICLE 9 of this Agreement, and shall cause its accounting firm to abide by confidentiality restrictions consistent with those hereunder and requiring such firm to retain all such financial information in confidence in a manner consistent with ARTICLE 9 hereof. |
7.11 |
Late Payments. All payments under this Agreement shall earn interest from the date due until paid at a per annum rate equal to [***]. Interest will be calculated on an actual/360 basis. An example of the interest rate calculation follows, assuming that [***] |
[***]
[***]
7.12 |
Withholding Taxes. Payments under this ARTICLE 7 will be subject to any applicable withholding or deduction for or on account of Tax and no Party will be obliged to pay additional amounts in respect of any such withholding or deduction. When a Party becomes aware that it will have an obligation to deduct or withhold an amount for or on account of Tax from any such payment under this ARTICLE 7 it shall notify the Party |
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who is entitled to receive the payment in writing as soon as reasonably practicable. The Parties shall (a) co-operate in good faith and in a timely manner to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation treaty or domestic exemption which may apply to eliminate or reduce such deduction or withholding and (b) provide the other Party with such assistance as is reasonably required to obtain a refund of any Tax required to be so deducted or withheld, or to obtain a credit with respect to such Tax. In the event that (x) there is no applicable double taxation treaty or domestic exemption which applies to eliminate such deduction or withholding, or (y) an applicable double taxation treaty or domestic exemption reduces but does not eliminate such deduction or withholding, then, in each case, the payor shall deduct an amount equal to any Tax required to be deducted or withheld from the amount due to the payee, account for such Tax to the relevant Tax Authority within the time allowed by Applicable Law and secure and send to the payee the best available evidence of payment of such Tax. |
7.13 |
VAT. All payments under this Agreement are exclusive of any VAT. If any VAT is chargeable in respect of a payment under this Agreement and the Party making the supply (the supplier) is required to account for any VAT due to the relevant Tax Authority, the Party receiving the supply (the recipient) agrees that it shall pay such VAT at the applicable rate in respect of such payment following receipt, where applicable, of a VAT invoice in the appropriate form issued by the supplier in respect of such payment. The Parties shall issue invoices for all amounts payable under this Agreement consistent with VAT requirements and irrespective of whether the sums may be netted for settlement purposes. If any VAT originally paid by the recipient to the supplier in accordance with this Section 7.13 is in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the supplier to obtain a refund of such VAT from the relevant Tax Authority and the supplier shall pay an amount equal to any such VAT repaid by the relevant Tax Authority to the recipient within [***] of receipt. |
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ARTICLE 8
INTELLECTUAL PROPERTY
8.1 |
Ownership of Intellectual Property. |
8.1.1 |
F-star Ownership. As between the Parties, F-star shall Control all right, title, and interest in and to any and all F-star IP. |
8.1.2 |
Beta Ownership. As between the Parties, Beta shall Control all right, title, and interest in and to any and all Beta IP. |
8.1.3 |
Delta Ownership. As between the Parties, Delta shall solely own all right, title, and interest in and to any and all Delta IP. |
8.1.4 |
Ares Ownership. As between the Parties, Ares shall solely own all right, title, and interest in and to any and all Ares Background IP. |
8.1.5 |
Ownership of Preclinical Program Development Plan Improvements. As between the Parties on a Preclinical Program Development Plan by Preclinical Program Development Plan basis, in respect of any Improvements conceived, discovered, developed, or otherwise made in the performance of each Preclinical Program Development Plan prior to the Option Exercise Fee Payment Date: |
(a) |
Delta shall own all Improvements that specifically relate to and/or claim any Subject mAb2 (but not the Fcab or Fab components independently of the Subject mAb2) (Delta Pre-Data Package Improvements); |
(b) |
Beta shall own all Improvements that specifically relate to and/or claim any Fcab or Fab comprising the components of a Subject mAb2 (Beta Pre-Data Package Improvements); and |
(c) |
F-star shall own any other Improvements conceived, discovered, developed, or otherwise made in the performance of a Preclinical Program Development Plan (F-star Pre-Data Package Improvements). |
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8.1.6 |
Ownership of Improvements following Option Exercise Fee Payment Date. As between the Parties, on a Subject mAb2-by-Subject mAb2 basis: |
(a) |
Ares shall own any Improvements conceived, discovered, developed, or otherwise made following the Option Exercise Fee Payment Date in respect of such Subject mAb2 that specifically relate to and/or claim such Subject mAb2 (Ares Post-Data Package Improvements); |
(b) |
Beta shall own any Improvements conceived, discovered, developed, or otherwise made following the Option Exercise Fee Payment Date that specifically relate to and/or claim any Fcab or Fab comprising the components of a Subject mAb2 (Beta Post-Data Package Improvements); and |
(c) |
F-star shall own any Improvements conceived, discovered, developed, or otherwise made following the Option Exercise Fee Payment Date which relate to any F-star Patents and which are not Ares Post-Data Package Improvements or Beta Post-Data Package Improvements (F-Star Post-Data Package Improvements). |
8.1.7 |
Disclosure Obligation. In the event that any Improvements are conceived, discovered, Developed or made by or on behalf of a Party (for the purposes of this Section 8.1.7, the Inventing Party) which is owned by another Party pursuant to Section 8.1.5 (for the purposes of this Section 8.1.7, the Owning Party), such Inventing Party shall promptly disclose to the relevant Owning Party in writing, the conception, discovery, Development or making of such Improvement. |
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8.1.8 |
Assignment Obligation. |
(a) |
Delta, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), (i) to Beta all its right, title and interest in and to any Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements, including all rights to sue for past infringement of any Beta Pre-Data Package Improvements, and Beta Post-Data Package Improvements; and (ii) to F-star Ltd all its right, title and interest in and to any F-star Pre-Data Package Improvements, including all rights to sue for past infringement of any F-star Pre-Data Package Improvements. Delta will, at its cost, provide necessary information, execute and record assignments and other necessary documents, and take any other necessary steps to effect such assignments and consistent with such ownership. |
(b) |
F-star, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), (i) to Delta all its right, title and interest in and to any Delta Pre-Data Package Improvements, including all rights to sue for past infringement of any Delta Pre-Data Package Improvements; and (ii) to Beta all its right, title and interest in and to any Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements, including all rights to sue for past infringement of any Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements. F-star will, at its cost, provide necessary information, execute and record assignments and other necessary documents, and take any other necessary steps to effect such assignments and consistent with such ownership. |
(c) |
Beta, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future |
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hereby agrees to assign), (i) to Delta all its right, title and interest in and to any Delta Pre-Data Package Improvements, including all rights to sue for past infringement of any Delta Pre-Data Package Improvements; and (ii) to F-star Ltd all its right, title and interest in and to any F-star Pre-Data Package Improvements, including all rights to sue for past infringement of any F-star Pre-Data Package Improvements. Beta will, at its cost, provide necessary information, execute and record assignments and other necessary documents, and take any other necessary steps to effect such assignments and consistent with such ownership. |
(d) |
Ares, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign), (i) to Delta all its right, title and interest in and to any Delta Pre-Data Package Improvements, including all rights to sue for past infringement of any Delta Pre-Data Package Improvements; and (ii) to Beta all its right, title and interest in and to any Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements, including all rights to sue for past infringement of any Beta Pre-Data Package Improvements and Beta Post-Data Package Improvements; and (iii) to F-star all its right, title and interest in and to any F-star Pre-Data Package Improvements and F-star Post-Data Package Improvements, including all rights to sue for past infringement of any F-star Pre-Data Package Improvements and F-star Post-Data Package Improvements. Ares will, at its cost, provide necessary information, execute and record assignments and other necessary documents, and take any other necessary steps to effect such assignments and consistent with such ownership. |
(e) |
Each Party shall cause all Persons who perform Development activities for such Party under this Agreement to be under an obligation to assign their rights in any Information and |
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inventions resulting therefrom relating specifically to a Subject mAb2 and/or relating specifically to an Fcab comprised within a Subject mAb² to such Party, except where Applicable Law requires otherwise (in which case such Party shall obtain a suitable exclusive licence under those rights). No Party may instruct or employ any Person to perform Development activities for such Party with respect to its obligations hereunder where such Person (including without limitation governmental, not-for-profit and public institutions) has standard policies against, or otherwise refuses to grant, such an assignment or granting of such an exclusive licence (a Non-Assigning Person), save with the prior written consent of the other Parties. However, if a Party refuses its consent to the other Party instructing or employing a Non-Assigning Person, and there is no other Person that can perform the Development activities and give the required assignment on commercially reasonable terms, then the instructing Party shall not be in breach of its obligations to use Commercially Reasonable Efforts to perform any such Development activities hereunder or under the Delta IP Licence to the extent due to its inability to instruct the Non-Assigning Person. |
8.2 |
Maintenance and Prosecution of Patents. |
8.2.1 |
Patent Prosecution and Maintenance. |
(a) [***]
(b) [***]
(c) [***]
(i) [***]
(ii) [***]
(d) [***]
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8.2.2 |
Fcab, Fab and Subject mAb2 Patent Prosecution and Maintenance. [***] |
(a) |
[***] |
(i) [***]
(ii) [***]
(iii) [***]
[***]
(b) |
The relevant prosecuting Party (determined in accordance with Section 8.2.1) shall be responsible for and shall undertake, and [***] shall cooperate with such prosecuting Party with regards to the prosecuting Partys activities associated with, the preparation, filing and prosecution of [***] in the Patent Cooperation Treaty applications in each of [***], (iii) file national patent applications in each of [***], and (iv) file foreign patent registrations in [***] (it being understood that filings may occur in additional jurisdictions, but that there shall be no obligation regarding filings in jurisdictions beyond those listed). |
(c) |
[***] shall be responsible for and shall use Commercially Reasonable Efforts to undertake, and the relevant prosecuting Party (determined in accordance with Section 8.2.1) shall cooperate with [***] with regards to [***] activities associated with, preparation, filing and prosecution of [***] in the Patent Cooperation Treaty applications in each of [***] and [***], (iii) file national patent applications in [***], and (iv) file foreign patent registrations in [***] (it being understood that filings may occur in additional jurisdictions, but that there shall be no obligation regarding filings in jurisdictions beyond those listed). |
(d) |
Except where [***] elects not to file or abandons [***], pay renewal fees and take reasonable actions to maintain such |
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Patents (including using Commercially Reasonable Efforts to prosecute to grant any [***] that are not yet granted, using reasonable efforts to defend any post-grant review or opposition proceedings regarding any such Patents, and to ensure that rights to priority dates with respect to such patents are not inadvertently lost). |
(e) |
Keep the other Parties reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance strategy (including timing of filing, data to be included, and scope of claims of patent applications) of any [***], and shall discuss steps with regard to the preparation, filing, and strategy (including timing of filing, data to be included, and scope of claims of patent applications) with respect to such Patents and shall reasonably consider the other Parties comments in respect of the same. |
(f) |
[***] shall keep [***] reasonably informed, on a [***] basis of the filing and grant of [***]. |
(g) |
In the event that an Insolvency Event occurs with respect to [***], then [***] shall have the right at its sole expense to assume control of the preparation, filing, prosecution and maintenance of any [***]. In support of [***] rights under this Section 8.2.2(g), [***] has granted to [***]. For the avoidance of doubt, [***] shall have no right to exercise its rights under [***] unless and until such time as an Insolvency Event occurs with respect to [***]. |
8.2.3 |
Other [***] and other [***] Prosecution and Maintenance. Each of [***] (with respect to the [***]) and [***] (with respect to the [***] other than [***]) shall: |
(a) |
keep [***] reasonably informed, on a [***] basis of the filing and grant of [***] which are not [***]; and |
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(b) |
use Commercially Reasonable Efforts to (i) pay renewal fees and take reasonable actions to maintain the [***] (including to prosecute to grant any such Patents that are not yet granted in at least the following jurisdictions: [***], and (ii) defend any post-grant review or opposition proceedings regarding any such Patents. Notwithstanding the foregoing, if [***], acting reasonably and in good faith, consider that taking such steps with respect to any such Patent in any particular jurisdiction would not be reasonable taking into account factors such as the likelihood of such Patent being granted, the scope of the patent that is likely to be granted (including the likelihood that the technology covered by the Patent or application will be infringed by the [***]) and/or the cost of prosecution and maintenance of such Patent compared to the scope of protection it might afford, then [***] (as relevant) may allow to lapse or not defend such Patent in such jurisdiction. |
8.2.4 |
CREATE Act. Notwithstanding anything to the contrary in this ARTICLE 8, neither Party shall have the right to state in a proceeding that a claimed invention falls under (i) the Cooperative Research and Technology Enhancement Act of 2004, pre-AIA 35 U.S.C. 103(c)(2)-(c)(3) (the CREATE Act) or (ii) the Leahy-Smith America Invents Act of 2011, 35 U.S.C. 100(h) and 102(c)(1)-(3) (the AIA) when exercising its rights under this ARTICLE 8 without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed. With respect to any such permitted statement, the Parties shall coordinate their activities with respect to any submissions, filings, or other activities in support thereof. The Parties acknowledge and agree that this Agreement is a joint research agreement as defined in the CREATE Act and AIA. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
8.3 |
Defence of Patents. |
8.3.1 |
Notice. Each Party shall promptly notify the other Parties in writing of any alleged, threatened or actual assertion of which it becomes aware of: |
(a) |
Infringement by any Third Party of any Fcab Patents or Fab Patents or Subject mAb2 Patents (save that with respect to any such infringement of an Fcab Patent or Fab Patent arising solely as a result of that Fcab or Fab comprising part of a mAb2 which is not a Subject mAb2, then the Party that becomes aware of such infringement shall have no obligation to provide such notice if that Party does not intend to, and does not, take any steps to enforce the Fcab Patent or Fab Patent with respect to such infringement); |
(b) |
Misappropriation of or ownership or entitlement claim by a Third Party with respect to any Fcab Patent or Fab Patent or Subject mAb2 Patent; and/or |
(c) |
Invalidity or unenforceability of any Fcab Patent or Fab Patent or Subject mAb2 Patent by a Third Party, whether directly, or indirectly by way of an anticipated or existing defence to an anticipated, threatened or existing infringement action (including but not limited to an infringement assertion under Section 8.3.1(a) above), |
(a Third Party IP Claim) and shall in each case provide to the other Parties details of such alleged, threatened or actual assertion that are known by such Party. With respect to any claims falling within sub-Sections 8.3.1(b) or 8.3.1(c) above, each Party shall consider, in good faith, the comments of the other in respect of such Third Party IP Claim. If the information alerting a Party to a Third Party IP Claim is confidential, such Party shall use Commercially Reasonable Efforts to negotiate with the Person providing such information a right to disclose the information to the other Parties.
8.3.2 |
Information. The Party commencing or defending any Third Party IP Claim (an IP Action) shall keep the other Parties regularly informed of the status and progress of the IP Action, including by providing the other Parties with copies of any and all material pleadings and other documents filed with the court. |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
8.4 |
Enforcement of IP. |
8.4.1 |
Subject to the other provisions of this Section 8.4 below, as between the Parties: |
(a) |
F-star shall, at its own expense, have the sole and exclusive right, but not the obligation, to enforce and defend, and control the enforcement and defence, worldwide of the F-star IP. |
(b) |
Beta shall, at its own expense, have the sole and exclusive right, but not the obligation, to enforce and defend, and control the enforcement and defence, worldwide of the Beta IP. |
(c) |
Delta shall, at its own expense, have the sole and exclusive right, but not the obligation, to enforce and defend, and control the enforcement and defence, worldwide of the Delta IP; and |
(d) |
Ares shall at its own expense, have the sole and exclusive right, but not the obligation, to enforce and defend, and control the enforcement and defence, worldwide of the Ares IP. |
8.4.2 |
Enforcement of Subject mAb2 Patents. During the Term: |
(a) |
Until (but not including) the Option Exercise Fee Payment Date in respect of any Subject mAb2 Patents that specifically relate to and/or claim any Subject mAb2, Delta shall have the first right, but not the obligation, to enforce and defend worldwide under its control, and at its own expense Subject mAb2 Patents that specifically relate to and/or claim such Subject mAb2, and all costs of such preparation, filing, prosecution and maintenance shall be borne by Delta. |
(b) |
On and from the Option Exercise Fee Payment Date in respect of any Subject mAb2, Ares shall have the first right, but not the |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
obligation, to enforce and defend worldwide under its control, and at its own expense Subject mAb2 Patents that specifically relate to and/or claim such Subject mAb2, and all costs of such preparation, filing, prosecution and maintenance shall be borne by Ares. |
(c) |
In the event that the Party that has the first right to enforce and defend any Subject mAb2 Patents in accordance with this Section 8.4.2 (being Delta or Ares, as relevant) does not initiate or diligently prosecute or defend an action with respect to such an infringement or claim within [***] following notice thereof, or such shorter period as may be required to avoid any prejudicial ruling or effect, then the other Party (being Delta or Ares, as relevant) shall have the right to attempt to resolve such infringement or claim, including by filing an action. The Party controlling such action shall have the sole and exclusive right to select counsel. |
Neither Beta nor F-star shall have the right to enforce or defend the Subject mAb2 Patents.
8.4.3 |
Patent Exclusivity Listing. If any Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (PHSA) (a Biosimilar Application) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA), that Party shall, within [***], notify the other Parties so that the other Parties may seek permission to view the application and related Confidential Information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If any Party receives any equivalent or similar certification or notice in any other jurisdiction in the Territory, such Party shall, within [***], notify and provide the other Parties with copies of such communication. Regardless of the Party that is the reference product sponsor for purposes of such |
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Biosimilar Application, (a) Delta shall have the sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application; and (b) Delta shall have the sole right to list any Delta Patents, insofar as they claim or cover the applicable Licensed Product as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilise a different mechanism for information exchange than that specified in Section 351(l) of the PHSA. |
8.4.4 |
Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in this Section 8.4.4, Delta or Ares shall have the sole right to bring an action for infringement of the Delta Patents in accordance with the provisions of Section 8.4.2, with respect to Subject mAb2 or Licensed Products as required under Section 351(l)(6) of the PHSA following the agreement on a list of Patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B) of such act, or as required following any equivalent or similar certification or notice in any other jurisdiction. The Parties rights and obligations with respect to the foregoing legal actions shall be as set forth in this Section 8.4.4 provided, that within [***] of reaching agreement on a list of Patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B), Delta or Ares (as determined in accordance with the provisions of Section 8.4.2) shall notify Beta as to whether or not it elects to prosecute such infringement. Either Party shall, within [***], notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction. Thereafter, Delta or Ares (as determined in accordance with the provisions of Section 8.4.2) shall have the first right to seek an injunction against such commercial marketing as permitted pursuant to Section 351(l)(8)(B) of the PHSA. |
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8.4.5 |
Cooperation. The Parties agree to cooperate fully in respect of the enforcement of any Subject mAb2 Patent or Fcab Patent (an IP Action), as follows: |
(a) |
The Party commencing or defending the litigation (the Lead Party) shall keep the other Parties regularly informed of the status and progress of the IP Action, including by providing the other Parties with copies of any and all material pleadings and other documents filed with the court, and the Lead Party shall have due regard to the interests of the other Parties. |
(b) |
At the reasonable request of the Lead Party, the other Parties shall, where necessary and (subject to the Lead Party indemnifying the other Parties in respect of any liabilities it may incur relating to joining such action) furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action or proceeding (in which case it shall have the right, but not the obligation, to instruct and be represented by independent counsel of its own choice and at its own expense), providing access to relevant documents and other evidence, and making its employees available at reasonable business hours. |
(c) |
In no event shall any Party; |
(i) |
make an admission as to liability, or the invalidity or unenforceability of any Subject mAb2 Patent or Fcab Patent or Fab Patent or IP that is owned by another Party; |
(ii) |
amend in the course of the litigation any Patent that forms part of any Subject mAb2 Patent or Fcab Patent or Fab Patent; or |
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(iii) |
agree to any settlement or compromise of any action or proceedings relating to any IP Action, |
in each case in a manner that diminishes or has a material adverse effect on the rights or interest of the other Parties, or in a manner that imposes any costs or liability on, or involves any admission by, the other Parties, without the express written consent of such other Parties, such consent not to be unreasonably withheld, conditioned or delayed.
8.4.6 |
Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realised as a result of an IP Action (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any remainder after such reimbursement is made shall [***]. |
8.5 |
Inventors Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Partys inventors under any applicable inventor remuneration laws. |
ARTICLE 9
CONFIDENTIALITY AND NON-DISCLOSURE
9.1 |
Confidentiality Obligations. At all times during the Term and for a period of [***] following termination or expiration of this Agreement, each Party shall cause its Affiliates and its and their respective officers, directors, employees, consultants, contractors and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or |
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other competent proof, the confidentiality and non-use obligations under this Section 9.1 with respect to any Confidential Information shall not include any information that: |
9.1.1 |
was publicly known when received from the disclosing Party or thereafter becomes publicly known through no wrongful act, fault or omission on the part of the receiving Party; |
9.1.2 |
was in the receiving Partys possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
9.1.3 |
is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
9.1.4 |
is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
9.1.5 |
has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Partys Confidential Information. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
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9.2 |
Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
9.2.1 |
in the reasonable opinion of the receiving Partys legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators, but subject to Section 9.4); provided that the receiving Party shall first have given prompt written notice (and to the extent practically possible, at least [***] notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information (for example, to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed; |
9.2.2 |
requested by any Tax Authority, whether or not the request has the force of law; |
9.2.3 |
made by or on behalf of the receiving Party or their licensees or sub-licensees to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with Applicable Law; |
9.2.4 |
subject to written consent of the disclosing Party, made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining, defending or enforcing a Patent in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information, to the extent such protection is available; |
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9.2.5 |
made to its or its Affiliates financial and legal advisors who have a need to know such disclosing Partys Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, at least as restrictive as those set forth in this Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and legal advisors, to treat such Confidential Information as required under this ARTICLE 9; |
9.2.6 |
made by the receiving Party or its Affiliates to potential or actual investors, acquirers, investment bankers, lenders, as may be reasonably necessary in connection with their evaluation of a potential or actual investment in or acquisition of the receiving Party or its Affiliates; provided that: |
(a) |
such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 9 other than in respect of the duration which shall be commensurate with the purpose for which the information was disclosed and relevant market practice; |
(b) |
the scope of any such disclosure by an F-star Party shall be limited to (i) the Transaction Documents and the identity of the Targets of the Subject mAb2, but excluding the Preclinical Program Development Plan and (ii) an estimate of the time required to complete each Preclinical Program Development Plan which remains uncompleted at such time (but, for the avoidance of doubt, without specifying what activities remain to be performed under such Preclinical Program Development Plan or communicating any scientific data or results generated by |
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such Preclinical Program Development Plan or otherwise or any other scientific content relating to the Preclinical Program Development Plan or the collaboration generally); |
(c) |
without prejudice to sub-Section 9.2.6(b), in the event that an F-star Party seeks Ares consent to the disclosure of the outcomes of any Preclinical Program Development Plan (but not, for the avoidance of doubt, the contents of any Preclinical Program Data Package), Ares shall not unreasonably condition, withhold or delay such consent; and |
(d) |
a Party or one of its Affiliates seeking to disclose Confidential Information in reliance on this Section 9.2.6 shall give reasonable advance notice of such intention, specifying the Third Party to whom it proposes to make such disclosures; |
9.2.7 |
made by Ares or its Affiliates or Sublicensees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective (i) collaboration partners, (ii) licensees, (iii) sublicensees, or other Third Parties as may be necessary or useful in connection with the Exploitation of any Subject mAb2, the Licensed Products, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 9 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors); or |
9.2.8 |
made by an F-star Party or any of their respective Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, prospective (i) collaboration partners, (ii) licensees, (iii) sublicensees, or other Third Parties as may be necessary or useful in connection with the |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Exploitation of any Subject mAb2, the Licensed Products, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement (including in relation to the exercise of the rights granted to Delta in Section 5.1 or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement); provided that: |
(a) |
such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of Ares substantially similar to the obligations of confidentiality and non-use of Delta pursuant to this ARTICLE 9 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, contractors and the like); and |
(b) |
no F-star Party shall disclose any Confidential Information relating to any Preclinical Program Development Plan or Subject mAb2 in reliance on this Section 9.2.8 without the prior written consent of Ares (such consent not to be unreasonably conditioned, withheld or delayed). |
9.3 |
Use of Name. Except as expressly provided herein, no F-star Party or any of their respective Affiliates shall mention or otherwise use the name, logo, or trademark of Ares or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of Ares. Except as expressly provided herein, neither Ares nor any of its Affiliates shall mention or otherwise use the name, logo, or trademark of an F-star Party or any of their Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of Delta. The restrictions imposed by this Section 9.3 shall not prohibit either Party from making any disclosure identifying the other |
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*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Party that, in the opinion of the disclosing Partys counsel, is required by Applicable Law; provided that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. |
9.4 |
Public Announcements. The Parties have agreed that the F-star Parties may issue a press release in the form set out as Schedule 9.4. Other than this press release and as expressly set forth in this ARTICLE 9, none of the F-star Parties, Ares or any of their respective Affiliates shall issue any public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the other Parties prior written consent, except for any such disclosure that is, in the opinion of the disclosing entitys counsel, (i) material to the proper explanation of the disclosing entitys business (including the mAb2 Target Pair of [***]) for the purpose of making filings that are reasonably necessary in respect of a filing pursuant to the rules of a stock exchange or (ii) that are otherwise required by Applicable Law or the rules of a stock exchange; in each case on which the securities of the disclosing entity are listed (or to which an application for listing has been submitted). In the case of (i) and (ii) above: |
9.4.1 |
such entity shall submit the proposed disclosure in writing to Ares (if the entity is an F-star Party) or Delta (if the entity making the disclosure is Ares) as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon, and the disclosing Party shall give reasonable consideration to the concerns of the non-disclosing Party in respect of such disclosure; and |
9.4.2 |
the scope and content of the disclosure shall not (without the prior written consent of the non-disclosing Party) extend beyond the information which the disclosing Party is required by Applicable Law or the rules of the relevant stock exchange to disclose (as supported by written opinion from the disclosing Partys counsel). |
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9.5 |
Publications. The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the Development activities hereunder and neither Party shall make any publications, presentations or public disclosures related to a Subject mAb2 unless mutually agreed by the Parties. Notwithstanding the foregoing: |
9.5.1 |
each F-star Party and each of their respective Affiliates shall have the right to make any publications, presentations or public disclosures relating to (a) any Fcabs or (b) any Antibody other than to the extent related to a Subject mAb2 or Licensed Product, in each case without any approval, review or comments rights by Ares. The Parties have agreed that the publications identified in Schedule 9.5 have been agreed in principle by the Parties and Delta shall provide a copy of each such publication to Ares at least [***] prior to its submission for publication and shall, in good faith, give reasonable consideration to Aress comments in relation to such publication, whereby it is understood that for the timeline of the respective submission Ares´ publication guidelines shall apply; and |
9.5.2 |
Ares shall, after payment of the respective Option Exercise Fee in respect of a Subject mAb2, have the right to make publications relating to such Subject mAb2 and Licensed Product provided that it provides Delta with a copy of such publication at least [***] prior to submission and on Deltas reasonable request (i) removes from such publication any of Deltas Confidential Information and (ii) takes into account any reasonable comments Delta may have in respect of such publication. |
9.6 |
Return of Confidential Information. Upon the effective date of the termination of this Agreement with respect to any Accepted mAb2 Target Pair for any reason, any Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first |
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Party does not retain rights under the surviving provisions of this Agreement: (a) as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) as soon as reasonably practicable, deliver to the requesting Party, at the other Partys expense, all copies of such Confidential Information in the possession of the other Party; provided that the other Party shall be permitted to retain one (1) copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder or if required by Applicable Law. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Partys automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Partys standard archiving and back-up procedures, but not for any other use or purpose. |
9.7 |
Delta Permitted Disclosure. In the event that Ares fails to pay the Preclinical Program Data Package Delivery Payment in accordance with the terms of this Agreement in respect of a particular Subject mAb2 , or if this Agreement is otherwise terminated or expires in respect of such Subject mAb2, Delta will be permitted to disclose Confidential Information relating to such Subject mAb2 to a potential Third Party strategic partner interested in a transaction involving that Subject mAb2; provided, that such disclosure is subject to the provisions of Section 9.1 and 9.2 with respect to Ares Confidential Information. |
ARTICLE 10
DATA PROTECTION AND PRIVACY
10.1 |
For the purposes of this ARTICLE 10, the terms, controller, processor, data subject, third country and supervisory authority shall have the meaning ascribed to the corresponding terms in the Applicable DP Laws. |
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10.2 |
The Parties acknowledge that the EU GDPR will be or may become applicable to the Processing of Personal Data in connection with this Agreement and agree to Process any Personal Data in accordance with the EU GDPR (irrespective of its actual application) and other Applicable DP Laws. Any Personal Data which: |
10.2.1 |
Ares receives from or on behalf of Delta or which Delta receives from or on behalf of Ares; and/or |
10.2.2 |
is Processed by any Party (as applicable), |
as part of this Agreement shall be Processed by that Party only in strict compliance with Applicable DP Laws. Each Party will Process Personal Data exclusively for the purposes of this Agreement.
10.3 |
Each Party shall treat the relevant Personal Data in accordance with the provisions of this ARTICLE 10 and shall only Process and store relevant Personal Data for as long as it is necessary in connection with this Agreement, requested by another Party in writing, or otherwise required by Applicable DP Laws. Each Party shall ensure that all Persons entrusted with the Processing of Personal Data in accordance with the Agreement are under substantially similar obligations. |
10.4 |
Each Party will, on request, provide the others at its the expense of the requesting Party (unless otherwise agreed to by the Parties in writing) with reasonable assistance, information and cooperation to ensure compliance with the respective obligations of the requesting Party under Applicable DP Laws in relation to the relevant Personal Data. |
10.5 |
Each Party shall implement appropriate technical and organisational security measures in relation to the Processing of the relevant Personal Data, which shall ensure a level of security appropriate to the risk including, as appropriate, (a) pseudonymisation and encryption; (b) the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services; (c) the ability to restore the |
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availability and access to such Personal Data in a timely manner in the event of a physical or technical incident; and (d) a process for regularly testing, assessing and evaluating the effectiveness of those measures. |
10.6 |
Exchange of Personal Data. |
10.6.1 |
The Parties acknowledge and agree that where they Process Personal Data for the purposes of the Collaboration under this Agreement, to the extent relevant under the EU GDPR, each Party will act as an independent controller and will be solely responsible for its own Processing activities. |
10.6.2 |
If and to the extent Personal Data is Processed by or on behalf of Ares by Delta, or by or on behalf of Delta by Ares, pursuant to the performance of the Agreement, so that Delta or Ares, as the case may be, is acting as a processor, a Processing agreement shall be agreed by Delta and Ares in order to comply with the requirements under Applicable DP Laws. |
10.6.3 |
If and to the extent that Delta and Ares act as Joint Controllers pursuant to the performance of the Agreement, Delta and Ares shall agree in writing on a Joint Controller agreement that determines their respective responsibilities for compliance with the Applicable DP Laws and that shall apply in addition to the other provisions of this ARTICLE 10. |
10.7 |
Cross-Border Transfer. Any transfer of relevant Personal Data by either Party to a third country outside the European Economic Area in connection with this Agreement shall only be made in accordance with Articles 44 to 50 of the GDPR and other Applicable DP Laws. The Parties agree to implement appropriate safeguards in accordance with Article 46 of the GDPR where necessary for the transfer of Personal Data for the purposes of the Collaboration under this Agreement; this includes the obligation to enter into, where necessary, standard data protection clauses adopted by the European Commission (from time to time) for the transfer of Personal Data from controllers established inside the European Economic Area to controllers or processors (as applicable) established in countries or territories outside the European Economic Area that are not Adequate Countries (Model Clauses). |
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10.8 |
Subcontracting. In the event that any Third Party subcontractor appointed in accordance with this Agreement has access to and/or Processes Personal Data that is subject to this Agreement, the subcontracting Party shall appoint such Third Party subcontractor as a data processor under a written contract which shall comply with the EU GDPR and shall ensure that the Third Party subcontractor complies with the subcontracting Partys obligations under this Clause, including, without limitation, by entering into Model Clauses (if and to the extent required). |
10.9 |
Breach Notification. Each Delta and Ares shall promptly notify the other in writing after becoming aware of any breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, Personal Data (as applicable to the other Party) subject to this Agreement (the Data Breach). The latter Party may then request from the notifying Party further reasonable information about the Data Breach, including a reasonably detailed description of the Data Breach and the categories of Personal Data affected by the Data Breach, and will work together to identify a root cause of, and to remediate such Data Breach. Each Party shall co-operate with the other, to the extent reasonably requested, in relation to any notifications to supervisory authorities or to Persons which either Party is required to make under DP Laws. |
10.10 |
Data Privacy Audits. Each Party shall have the right during the Term, and for a period of [***] following termination of this Agreement, to conduct an investigation and audit of the other Partys activities, books and records, to the extent they relate to that other Partys performance under this Agreement, to verify compliance with the terms of this ARTICLE 10; provided, however, that such books and records may not be audited more than once per Calendar Year and that such investigation or audit shall be conducted during normal business hours, upon reasonable prior notice and |
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performed at the sole and exclusive expense of the auditing Party. The other Party shall cooperate fully with such investigation or audit, the scope, method, nature and duration of which shall be at the sole reasonable discretion of the auditing Party. |
10.11 |
Supervisory Authority communications and Data Subject Requests. |
10.11.1 |
If a Party (the Data Receiving Party) receives any complaint, notice or communication from a supervisory authority which relates directly or indirectly to the other Partys: (i) Processing of the Personal Data; or (ii) a potential failure to comply with Applicable DP Laws in respect of the performance of this Agreement, the Data Receiving Party shall, to the extent permitted by law, promptly forward the complaint, notice or communication to the other Party and provide the other Party with reasonable co-operation and assistance in relation to the same. |
10.11.2 |
If a Person makes a written request to a Party to exercise their rights in relation to the Personal Data that concerns Processing in respect of which another Party is the controller, that Party shall forward the request to the other Party promptly and in any event within [***] from the date on which it received the request and, upon the other Partys reasonable written request, provide that other Party with reasonable co-operation and assistance in relation to that request to enable the other to respond to such request and meet applicable timescales set out under Applicable DP Laws. |
ARTICLE 11
WARRANTIES AND COVENANTS
11.1 |
Fundamental Warranties. Each of the F-star Parties hereby warrants to Ares, and Ares hereby warrants to each of the F-star Parties, that as at the Effective Date: |
11.1.1 |
Organisation. It is a corporation duly organised, validly existing, and in good standing under the laws of the jurisdiction of its organisation, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement and (with respect to the respective F-star Parties) the other Transaction Documents. |
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11.1.2 |
Authorisation. The execution and delivery of this Agreement and (with respect to the respective F-star Parties) the other Transaction Documents as well as the performance by it of the transactions contemplated hereby have been duly authorised by all necessary corporate action, and do not violate (a) its charter documents, bylaws, or other organisational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which it is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to it. |
11.1.3 |
Binding Agreement. This Agreement and (with respect to the respective F-star Parties) the other Transaction Documents are legal, valid, and binding obligation of it, enforceable in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). |
11.1.4 |
Debarment. It has not, to its knowledge, employed or used a contractor or consultant that has employed any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA) or, to its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any preclinical activities in respect of any Subject mAb2 as of the Effective Date. |
11.1.5 |
No Inconsistent Obligation. It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfilment of its obligations hereunder. |
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11.2 |
Business Warranties. Each of the F-star Parties (for itself and for each of the other F-star Parties) warrants to Ares that, except as Fairly Disclosed in Schedule 11.2A, each of the F-star Business Warranties is, as of the Effective Date, true and accurate. |
11.3 |
Where an F-star Business Warranty is qualified by the expression so far as the F-star Parties are aware or to the best of the knowledge, information and belief of the F-star Parties or any similar expression, the F-star Parties shall be deemed to have knowledge of anything of which they would have known, had they made due and careful enquiries of Eliot Forster, Jane Dancer, Tolga Hassan, Mihriban Tuna, Neil Brewis, Alison McGhee and Mike Davies. |
11.4 |
Covenants. |
11.4.1 |
Subject to Section 13.6.3, no F-star Party shall, without the prior written consent of Ares, grant any security interest, option, mortgage, charge or lien over any Delta Patent during the Term. |
11.4.2 |
During the Term, neither Beta nor F-star shall encumber or adversely affect the rights granted to Ares hereunder with respect to the Beta IP or F-star IP insofar as it relates to the Exploitation of Subject mAb2 and Licensed Products in a manner that would adversely affect any rights of Ares under this Agreement. |
11.4.3 |
During the Term, Delta shall timely pay in full all amounts required to be paid by Delta, and each of Delta and Beta shall timely perform in full all obligations required to be performed by it, under the Delta IP Licence. Without the prior express written consent of Ares, neither Delta nor Beta shall (and neither shall take any action or make any omission to) breach, modify or waive any provision of the Delta IP Licence that could impair the value of the licenses to Ares herein, or to terminate or have terminated or allow to expire the Delta IP Licence. |
11.4.4 |
Prior to the Preclinical Program Data Package Delivery Date in respect of [***] (or earlier termination of this Agreement with respect to [***]), Delta |
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shall timely pay in full all amounts required to be paid by Delta, and each of Delta and Beta shall timely perform in full all obligations required to be performed by it, under the Delta Support Services Agreement. Without the prior express written consent of Ares, neither Delta nor Beta shall (and neither shall take any action or make any omission to) breach, modify or waive any provision of the Delta Support Services Agreement that could impair the value of the licenses to Ares herein, or to terminate or have terminated or allow to expire the Delta Support Services Agreement. |
11.4.5 |
During the Term, all contracts entered into between Delta, on the one hand, and any other F-star Party, on the other hand that relate specifically to this Agreement shall be in writing and shall be on arms length terms. |
11.4.6 |
Delta and Beta (as the case may be) shall inform Ares without undue delay in the event (i) of the occurrence of an Insolvency Event with respect to Beta or Delta or (ii) that the Board of Directors of Beta or Delta resolves that Beta or Delta, as the case may be, is insolvent (as defined in Section 123 of the Insolvency Act 1986). |
11.4.7 |
Delta shall fulfil all of its obligations, including but not limited to its payment obligations, under the Transaction Documents. |
11.4.8 |
Consolidation. The F-star Parties undertake that: |
(a) |
promptly following the Effective Date it shall undertake a review of the financial and other implications of the transfer by Delta of all of its rights and obligations under this Agreement to Beta. In the event that the F-start Parties conclude that there are no material adverse consequences to such a transfer and subject to Ares agreeing an amended and restated version of this Agreement pursuant to which Beta assumes responsibility for all of Deltas obligations hereunder, then (a) the Parties other than Delta shall enter into such amended and restated version of this Agreement, (b) the Parties other than Delta shall enter into a release of Delta from all of its future obligations and liabilities |
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hereunder and (c) Delta shall assign and transfer all of its rights and assets relating to the Subject mAb2 to Beta and the date of such transfer shall be the Subject mAb2 Transfer Date; |
(b) |
Delta shall not, prior to the earlier of (i) the Preclinical Data Package Delivery Date for [***] (or earlier termination of this Agreement with respect to [***]) and (ii) the Subject mAb2 Transfer Date transfer the rights held by Delta in respect of the mAb2 known as FS118 to any other F-star Party or to any Third Party; and |
(c) |
if, prior to the earlier of (i) the Preclinical Data Package Delivery Date for [***] (or earlier termination of this Agreement with respect to [***]) and (ii) the Subject mAb2 Transfer Date, Ares gives notice in writing to Delta that (a) the application of IFRS by Aress management leads to a requirement for Ares to consolidate Delta into the financial statements of Ares or any Affiliate of Ares; (b) the applicable financial standard setting bodies issue new requirements which lead to a requirement for such consolidation; or (c) Aress auditors or any regulatory body require such consolidation (together a Consolidation Requirement), in each case, the F-star Parties shall reasonably cooperate and otherwise provide Ares with reasonable assistance in resolving any issue that causes such Consolidation Requirement |
(d) |
Provision of Financial Information. In the event that (i) the application of IFRS by a Partys management leads to the requirement of a consolidation of the other Party (or of one or more of its Affiliates) by such Party; (ii) the applicable financial standard setting bodies issue new requirements which lead to the requirement of consolidation; or (iii) a Partys auditors or any regulatory body require such consolidation, and the Consolidation Requirement could not be resolved, such other |
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Party will reasonably cooperate and otherwise provide such Party with reasonable assistance in preparing such consolidated statements, including, if and to the extent needed, by providing such Party on a quarterly basis such other Partys income statements, cash flow statements, balance sheets and any other financial information requested by such Party in connection therewith in the form reasonably requested by such Party and prepared in accordance with IFRS. |
11.5 |
Both Parties Additional Representations, Warranties and Covenants. Each Party warrants and covenants to the other Parties that, as of the Effective Date and thereafter during the Term, |
11.5.1 |
such Party, with respect to activities undertaken in connection with this Agreement or with the Development of the Subject mAb² or a Licensed Product prior to the Effective Date, will conduct or has conducted its business in accordance with environmental, labour and social standards and in accordance with the standards set forth in the Merck Code of Conduct and the Merck Human Rights Charter (available at http://www.merckgroup.com). Each Party further acknowledges and ensures that it and its Affiliates, Sublicensees or subcontractors are familiar with the provisions of the United States Foreign Corrupt Practices Act, the UK Bribery Act and applicable local bribery and corruption laws, and each Party represents and warrants to the other Party that it will or has not taken or permitted any action that may either constitute a violation under, or cause the other Party to be in violation of, the provisions of the United States Foreign Corrupt Practices Act, the UK Bribery Act or applicable local bribery and corruption law, environmental, labour and social standards and the standards set forth in the Merck Code of Conduct and the Merck Human Rights Charter; |
11.5.2 |
such Party, with respect to activities undertaken in connection with this Agreement or with the Development of a Subject mAb² or a Licensed Product prior to the Option Exercise Fee Payment Date, will obtain, process |
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or store or has obtained, processed or stored all data related to human samples and other personal data obtained in course of the research, Development, manufacturing or Commercialization of the Subject mAb² or a Licensed Product in compliance with all Applicable Laws and in accordance with all medical, administrative and ethical aspects related to the collection, procession and storage of human samples, related data and other personal data in research activities. In particular, the signature of the informed consent from the donor has been and, in case of Ares, will be obtained and confidentiality and anonymization of the human samples have been and, in case of Ares, will be procured and the personnel involved in such activities has been and, in case of Ares, will be authorized and capable to perform such activities; and |
11.5.3 |
each Party, with respect to activities undertaken in connection with this Agreement or with the Development of the Subject mAb² or a Licensed Product prior to the Effective Date, will comply or has complied with all Applicable Laws for the care, welfare and ethical treatment of animals in the country where the research and Development is or was performed. In particular, Ares will adhere and each F-star Party shall adhere at a minimum to (a) Aress policy on the use, care and welfare of laboratory animals, (b) Aress Standard on Housing and Husbandry Practices for Common Laboratory Animals, (c) the principle of 3Rs reduction, refinement and replacement of animal studies; (d) the principle to offer state of the art housing and husbandry conditions in the care and use of animals which means access to species appropriate food and water; access to species specific housing, including species appropriate temperature and humidity levels; access to humane care and a program of veterinary care; animal housing that minimizes the development of abnormal behaviours; review of study design and purpose by institutional ethical review panel; commitment to minimizing pain and distress during the studies conducted under the research plan and that work is performed by demonstrable trained staff. |
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ARTICLE 12
INDEMNITY
12.1 |
Indemnification of Delta. Ares shall indemnify each of the F-star Parties, their Affiliates and their respective directors, officers, employees and agents (the Delta Indemnitees) and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (including reasonable attorneys fees and expenses) (collectively, Losses) in connection with any and all suits, investigations, claims, or demands of Third Parties (collectively, Third Party Claims) incurred by or rendered against the Delta Indemnitees arising from or occurring as a result of: |
(a) |
the Exploitation of any Subject mAb2 and/or Licensed Products after the respective Option Exercise Fee Payment Date in the Territory by or for Ares or any of its Affiliates, Sublicensees, subcontractors, agents and consultants; |
(b) |
the breach by Ares or its Affiliates of this Agreement; or |
(c) |
the negligence or wilful misconduct on the part of Ares or its Affiliates or their respective directors, officers, employees, and agents in performing its or their obligations under this Agreement, |
except for those Losses for which the F-star Parties, in whole or in part, have an obligation to indemnify Ares pursuant to Section 12.2 hereof, as to which Losses each Party shall indemnify the other in accordance with Sections 12.1 and 12.2 (as applicable) to the extent of their respective liability for such Losses.
12.2 |
Indemnification of Ares. The F-star Parties shall on a several basis and not jointly indemnify Ares, its Affiliates and its and their respective directors, officers, employees and agents (the Ares Indemnitees) on demand, and defend and hold each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims incurred |
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by or rendered against the Ares Indemnitees arising from or occurring as a result of: |
(a) |
the breach by an F-star Party or any of their respective Affiliates of any of the F-star Parties obligations under this Agreement; or |
(b) |
the negligence or wilful misconduct on the part of any of the F-star Parties in performing its obligations under this Agreement, |
except for those Losses for which Ares has an obligation to indemnify the F-star Parties pursuant to Section 12.1 hereof, as to which Losses each Party shall indemnify the other in accordance with Sections 12.1 and 12.2 (as applicable) to the extent of their respective liability for the Losses.
12.3 |
Claims relating to Indemnity Technology. The F-star Parties shall on a several basis and not jointly indemnify the Ares Indemnitees, on a Subject mAb2-by-Subject mAb2 basis, on demand, and defend and hold each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims which result from proceedings brought by a Third Party claiming that the use or practice of the Indemnity Technology by any Ares Indemnitee, as contemplated by or reasonably foreseeable in the context of this Agreement, infringes a Patent of such Third Party. This indemnity shall not apply to the extent that such Third Party Claims arise from or occur as a result of use by Ares of any Patent that does not relate specifically to the Indemnity Technology including any Patent claiming a Target, or the modulation of the activity thereof, or any downstream technology that Ares uses (for example with respect to Targets comprised in a mAb2 Target Pair or a manufacturing process or formulation used by Ares in respect of any Subject mAb2). Notwithstanding the foregoing provisions of this Section 12.3 above, the liability of the F-star Parties pursuant to this Section 12.3 above shall: |
12.3.1 |
be limited to [***] of all Losses suffered by the Ares Indemnitees as a result of a Third Party Claim pursuant to this Section 12.3; and |
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12.3.2 |
not in any event exceed the aggregate of: |
(a) |
an amount equal to [***]) of all milestone payments (as set out in Schedule 7.3) paid under this Agreement in respect of the relevant Subject mAb2 only in the [***] prior to the date on which the relevant Losses are notified to the F-star Parties; and |
(b) |
the amount of any milestone payments (as set out in Schedule 7.3) that become payable under this Agreement in respect of the relevant Subject mAb2 only, following the date on which the relevant Losses are notified to the F-star Parties (Future Milestone Payments), provided always that the Ares Indemnitees sole remedy under this Agreement in respect of an amount equal to the Future Milestone Payments shall be if any of the milestone payments set out in Schedule 7.3 in respect of the relevant Subject mAb2 remains unpaid at the relevant time, to set off any such milestone payments in respect of the relevant Subject mAb2 payable by Ares to Delta pursuant to Section 7.3 when it becomes due and payable against an amount (the Indemnity Set Off Amount) equal to any liability of Delta to Ares pursuant to this Section 12.3 above; provided always that the Ares Indemnitees shall not be entitled to exercise their rights pursuant to this Section 12.3.2(b) to the extent that the amount set off from any single Future Milestone Payment would in aggregate exceed (a) in the case of a Future Milestone Payment payable in respect of an event other than the achievement of Regulatory Approval of a Licensed Product in respect of the relevant Subject mAb2: [***]); or (b) in the case of a Future Milestone Payment payable in respect of the achievement of Regulatory Approval of a Licensed Product in respect of the relevant Subject mAb2: [***]. |
12.4 |
Notice of Claim. All indemnification claims in respect of a Party or their respective Affiliates, or their respective directors, officers, employees and |
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agents shall be made solely by such Party to this Agreement (the Indemnified Party). The Indemnified Party shall give the indemnifying party prompt written notice (an Indemnification Claim Notice) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under this ARTICLE 12, but in no event shall the indemnifying party be liable for any Losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the indemnifying party copies of all papers and official documents received in respect of any Losses and Third Party Claims. |
12.5 |
Control of Defence. |
12.5.1 |
In General. Except in circumstances where the Indemnified Party (acting reasonably) considers that such assumption might have a material adverse effect on its business or any part thereof or any relationship between the Indemnified Party and any of its customers, suppliers or other commercial counterparties or any Regulatory Authority, an indemnifying party may assume the defence of any Third Party Claim by giving written notice to the Indemnified Party within [***] after the indemnifying partys receipt of an Indemnification Claim Notice. The assumption of the defence of a Third Party Claim by the indemnifying party shall not be construed as an acknowledgment that the indemnifying party is liable to indemnify the Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the indemnifying party of any defences it may assert against the Indemnified Partys claim for indemnification. Upon assuming the defence of a Third Party Claim, the indemnifying party may appoint as lead counsel in the defence of the Third Party Claim any legal counsel selected by the indemnifying party which shall be reasonably acceptable to the Indemnified Party. In the event the indemnifying party assumes the defence of a Third Party Claim, the Indemnified Party shall immediately deliver to the indemnifying party all original notices and documents (including court |
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papers) received by the Indemnified Party in connection with the Third Party Claim. Should the indemnifying party assume the defence of a Third Party Claim, except as provided in Section 12.5.2, the indemnifying party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defence or settlement of the Third Party Claim unless specifically requested in writing by the indemnifying party. In the event that it is ultimately determined that the indemnifying party is not obligated to indemnify, defend or hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the indemnifying party for any Losses incurred by the indemnifying party in its defence of the Third Party Claim. |
12.5.2 |
Right to Participate in Defence. Without limiting Section 12.5.1, if an indemnifying party has assumed the defence of any Third Party Claim pursuant to Section 12.5.1, the Indemnified Party shall be entitled to participate in, but not control, the defence of such Third Party Claim and to employ counsel of its choice for such purpose; provided that such employment shall be at the Indemnified Partys own expense unless (a) the employment thereof, and the assumption by the indemnifying party of such expense, has been specifically authorised by the indemnifying party in writing or (b) the interests of the Indemnified Party and the indemnifying party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law, ethical rules or equitable principles. |
12.5.3 |
Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the Indemnified Partys becoming subject to injunctive or other relief or otherwise adversely affecting the business of the Indemnified Party in any manner, and as to which the indemnifying party shall have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the indemnifying party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of |
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such Loss, on such terms as the indemnifying party, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party Claims, where the indemnifying party has assumed the defence of the Third Party Claim in accordance with Section 12.5.1, the indemnifying party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss; provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). If the indemnifying party does not assume and conduct the defence of a Third Party Claim as provided above, the Indemnified Party may defend against such Third Party Claim. Regardless of whether the indemnifying party chooses to defend or prosecute any Third Party Claim, no Indemnified Party shall admit any liability with respect to, or settle, compromise or dispose of, any Third Party Claim without the prior written consent of the indemnifying party, which consent shall not to be unreasonably withheld, conditioned or delayed. The indemnifying party shall not be liable for any settlement, compromise or other disposition of a Loss by an Indemnified Party that is reached without the written consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned or delayed. |
12.5.4 |
Cooperation. Regardless of whether an indemnifying party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each indemnitee to, cooperate in the defence or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the indemnifying party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making Indemnified Parties and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the indemnifying party shall reimburse the Indemnified Party for all its reasonable out-of-pocket expenses in connection therewith. |
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12.5.5 |
Expenses. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis in arrears by the indemnifying party, without prejudice to the indemnifying partys right to contest the Indemnified Partys right to indemnification and subject to refund in the event the indemnifying party is ultimately held not to be obligated to indemnify the Indemnified Party. |
12.5.6 |
Special, Indirect, and Other Losses. EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 12, AND EXCLUDING ARTICLE 9 (CONFIDENTIALITY AND NON-DISCLOSURE), NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE FOR ANY LOSS OF PROFITS OR BUSINESS INTERRUPTION OR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE IN CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THE USE OF THE LICENSED PRODUCT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. |
12.6 |
Insurance. Each of the Parties shall, at their own respective expense, procure and maintain during the Term, insurance policies adequate to cover their respective obligations hereunder and consistent with the normal business practices of (i) with respect to Ares, prudent |
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pharmaceutical companies; and (ii) with respect to each F-star Party, prudent biotechnology companies, in each case of similar size and scope (or self-insurance). Such insurance shall not create a limit to either Partys liability hereunder. |
12.7 |
Certificates of Insurance. Upon request by Ares or Delta, the other Party shall provide Certificates of Insurance evidencing compliance with this Section. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain such insurance after the expiration or termination of this Agreement for the longer of (a) a period of [***] following termination or expiration of this Agreement in its entirety, or (b) with respect to a particular Party, last sale of a Licensed Product (or but for expiration or termination, would be considered a Licensed Product) sold under this Agreement by a Party. |
ARTICLE 13
TERM AND TERMINATION
13.1 |
Basis of Termination. This Agreement shall only expire or be terminated on a Subject mAb2-by-Subject mAb2 basis. Termination in respect of any one Subject mAb2 shall not affect the rights of the Parties in respect of each other Subject mAb2 and the relevant Preclinical Program Development Plan. |
13.2 |
Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect and shall expire on a Subject mAb2-by-Subject mAb2 basis, on the earlier of the date on which Ares has no further milestone payments or royalty obligations to Delta hereunder in respect of such Subject mAb2 and/or Licensed Product containing such Subject mAb2 (in respect of the relevant Subject mAb², the Term). |
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13.3 |
Termination for Convenience. Ares may terminate this Agreement on a Subject mAb2-by-Subject mAb2 basis, for any or no reason (i) immediately upon written notice if such termination notice is served within [***] after the relevant Preclinical Program Data Package Delivery Date; and thereafter, (ii) on [***] prior written notice to Delta if the termination is after the Preclinical Program Data Package Delivery Date but prior to the first Regulatory Approval in respect of the relevant Licensed Product containing such Subject mAb2 and (iii) on [***] prior written notice to Delta if the termination is after the first Regulatory Approval in respect of the relevant Licensed Product containing such Subject mAb2. |
13.4 |
Termination for Material Breach. |
13.4.1 |
If either Party (the Non-Breaching Party) believes that the other Party (the Breaching Party) has materially breached one (1) or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a Default Notice). If the Breaching Party fails to cure such breach within: |
(a) |
[***], in the event that Ares fails to pay any milestone payment payable on delivery of the Preclinical Program Data Package in respect of any Subject mAb2 in accordance with Section 7.3 when due; or |
(b) |
[***] in respect of any other material breach; |
after receipt of the Default Notice, the Non-Breaching Party may terminate this Agreement to the extent that it relates to the relevant Subject mAb2 or Licensed Product to which the breach relates, upon written notice to the Breaching Party.
13.4.2 |
If (i) Delta is the Breaching Party; (ii) such breach by Delta took place after the filing of the MAA in respect of the Subject mAb2 to which the relevant breach relates; and (iii) such breach by Delta is not cured within the periods |
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provided under Section 13.4.1, Ares may elect not to terminate this Agreement in respect of such Subject mAb² and, instead, during the period commencing at the end of the cure period and continuing until the end of the last Royalty Term for such Subject mAb² in all countries, reduce the milestone payments under Section 7.3 and the then applicable royalty rates by [***]; provided, that (a) such reduction shall be Ares sole remedy with respect to the breach by Delta and (b) for the avoidance of doubt, this remedy shall not be applicable in respect of any Subject mAb2 in respect of which Ares has not filed a MAA. |
13.5 |
Termination by Delta for Patent Challenge. Delta will have the right to terminate this Agreement in respect of a Subject mAb2 or Licensed Product upon written notice to Ares in the event that Ares or any of its Affiliates or Sublicensees directly assert in its own respective name or directs a Third Party to assert a Patent Challenge in relation to a Licensed Patent that covers the Manufacture, use or sale of the relevant Licensed Product; Patent Challenge means any challenge in a legal or administrative proceeding to the patentability, validity, ownership or enforceability of any of the Licensed Patents or (or any claim thereof), including by: (i) filing or pursuing a declaratory judgment action in which any of the Licensed Patents is alleged to be invalid or unenforceable; (ii) citing prior art against any of the Licensed (other than art required to be cited by Applicable Law, including under a duty of candor to a patent office), filing a request for or pursuing a re-examination of any of the Licensed Patents (other than with Deltas written agreement), or becoming a party to or pursuing an interference; or (iii) filing or pursuing any opposition, cancellation, nullity or other like proceedings against any of the Licensed Patents. |
13.6 |
Termination for Insolvency. |
13.6.1 |
If an Insolvency Event occurs in relation to a Party, then Ares (if the relevant Party is an F-star Party) or Delta (if the relevant Party is Ares) may terminate this Agreement in its entirety effective immediately upon written notice to the other Party. |
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13.6.2 |
In addition to rights provided under Section 13.6.1 in the event (i) of the occurrence of an Insolvency Event with respect to Beta or Delta or (ii) that the Board of Directors of Beta or Delta resolves that Beta or Delta, as the case may be, is insolvent (as defined in Section 123 of the Insolvency Act 1986) Ares shall to the extent permitted by Applicable Laws have the exclusive option to purchase and acquire all Delta Patents at an arms length fair market price provided that such purchase shall not relieve Ares of any of its payment obligations hereunder. Ares may exercise such option by written notice to Delta and/or Beta (as the case may be) (the Acquisition Notice) at any time within [***] after Ares is informed of the Insolvency Event or the resolution of the Board of Directors as above the occurrence of the respective Insolvency Event. Following the receipt of an Acquisition Notice, all of Deltas and/or Betas interest in the relevant Delta Patents shall automatically be transferred and assigned to Ares or the Affiliate of Ares specified in the Acquisition Notice. Following the option exercise, the arms length fair market price for the transferred Delta Patents shall be determined by mutual agreement of the Parties in good faith. In case of disagreement, an independent Third Party expert (who shall act as an expert and not as an arbitrator) (agreed upon by both Parties or, failing such agreement, designated and administered by the International Chamber of Commerce (the ICC) of London pursuant to the rules for expert proceedings of the ICC) shall determine the arms length fair market price taking into account that Ares payment obligations hereunder shall continue and such determination shall be final and binding upon the Parties. |
13.6.3 |
In consideration of the payments made by Ares and the rights granted to Ares under this Agreement, Ares shall be entitled at any time prior to the fifth (5th) anniversary of the filing date of the relevant PCT application to require in its discretion Beta and/or Delta to grant to Ares a security interest, in a form to be agreed by the Parties within [***] of the Effective Date |
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acting reasonably and in good faith, over any Delta Patent that Ares notifies to Beta and/or Delta (as the case may be) in writing. For this purpose: |
(a) |
Beta and Delta shall provide such information, and execute and record any documents and take any other steps, in each case that may be reasonably requested by Ares to effect and register Aress security interest over the relevant Delta Patent. |
(b) |
The security to be provided over any Patent in the UK will comprise an equitable charge and equivalent security in other jurisdictions will be interpreted accordingly. In addition, Delta or Beta (as the case may be) shall promptly deliver to the F-star Solicitors in respect of each Delta Patents over which Ares has requested a security interest pursuant this Section 13.6.3 a transfer instrument (in a form to be agreed by the Parties within [***] of the Effective Date acting reasonably and in good faith) providing for the transfer of that Patent from Delta to Ares and which is duly executed by Delta but not dated (any such instrument being a Patent Transfer Instrument). |
(c) |
As regards costs, the Parties agree that: |
(i) |
in relation to a request for security to be granted over any Delta IP or Beta IP in a Major Market, Delta or Beta (as the case may be) and Ares shall each bear the cost of its own legal fees and Delta shall bear the cost of any filing, registration, translation or other third party fees or costs which may be required in connection with the creation and registration of the relevant security (Registration Costs); |
(ii) |
in relation to a request for security to be granted over any Delta Patents in any jurisdiction other than a Major Market, Ares shall bear the cost of its own legal fees and any reasonable legal fees of Delta (provided such legal fees have been agreed with Ares in advance), together with any Registration Costs; and |
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(iii) |
except as provided in sub-Sections 13.6.3(c)(i) and 13.6.3(c)(ii), Ares and Delta or Beta (as applicable) shall each bear any other costs which they may incur in connection with the creation and registration of the relevant security (including any internal costs). |
13.6.4 |
Enforcement. |
(a) |
If an Insolvency Event occurs in relation to Delta or Beta, Ares shall be entitled to enforce any security which it holds over any Delta Patent (as applicable) and to issue a notice (an Enforcement Notification) to the F-star Solicitors. |
(b) |
Delta and Beta each agree that, upon receipt of an Enforcement Notification, the F-star Solicitors shall be authorised to and shall (with no further action required by or on behalf of any Party) be instructed in accordance with the Solicitors Letter to release any Patent Transfer Instruments which the F-star Solicitors hold in respect of the Delta Patent which are the subject of the Enforcement Notification to Ares, who is hereby authorised by Delta or Beta to date the same and take any further steps necessary to perfect the transfer of the relevant Delta Patent to Ares. |
13.6.5 |
An Insolvency Event shall be deemed not to have occurred in relation to an F-star Party for the purposes of this Section 13.6. for so long as Ares has failed to meet any payment obligation it has under this Agreement when due. |
13.6.6 |
In the event that an Insolvency Event occurs in relation to any F-star Party, Ares may request from that F-star Party, and the relevant F-star Party shall promptly provide, for so long as the circumstances giving rise to the |
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relevant Insolvency Event exist any information which Ares considers reasonably necessary or appropriate regarding the financial and operational position of the relevant F-star Party. |
13.7 |
Effect of Expiration of the Term. Following the expiration of the Term pursuant to Section 13.2, the licences in respect of the relevant Licensed Product in Section 5.3, shall become exclusive, fully-paid, royalty-free, sublicensable and irrevocable. |
13.8 |
Effects of Termination by Ares Without Cause or by Delta for Cause In the event of termination of this Agreement by Ares pursuant to Section 13.3 or by Delta pursuant to Section 13.4, 13.4.2 or 13.6 in respect of a Licensed Product, the following terms and conditions will apply with respect to such Licensed Product: |
13.8.1 |
All rights and licenses granted by Delta relating to the relevant Subject mAb2 or Licensed Products hereunder shall immediately terminate. Ares and its Affiliates will have no further rights to use any Licensed IP to Exploit the relevant Subject mAb2 or Licensed Products for which this Agreement has been terminated. |
13.8.2 |
Deltas and Ares obligations in respect of the Development, Commercialization and Manufacturing (if applicable) of the relevant Subject mAb2 or Licensed Products shall terminate; |
13.8.3 |
Delta shall have the sole right to prepare, file, prosecute and maintain Delta Patents that specifically relate to and/or claim the relevant Subject mAb2, and all costs of such preparation, filing, prosecution and maintenance shall be borne by Delta; |
13.8.4 |
Ares shall transfer and assign to Delta all of Aress and its Affiliates, title, and interests in and to any trademarks (but not any Ares or its Affiliates house marks) owned by Ares and used solely in connection with the Commercialization of the relevant Licensed Products; |
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13.8.5 |
As far as allowed under Applicable Law, Ares shall transfer to Delta all non-clinical and clinical data Controlled by Ares or its Affiliates to the extent related to the relevant Licensed Products; |
13.8.6 |
All Confidential Information generated by either Party in respect of the relevant Subject mAb2 shall be deemed to be the Confidential Information of Delta and Ares and its Affiliates shall treat such Confidential Information as though it had been disclosed to Ares by Delta; |
13.8.7 |
Ares shall, at the request of Delta (i) transfer and assign (to the extent permitted under Applicable Law) to Delta and on Deltas costs and expenses all regulatory materials and other documented technical and other information or materials owned and controlled by Ares or its Affiliates or Sublicensees, in each case, to the extent solely related to the relevant Licensed Products and necessary for Developing, Manufacturing or Commercializing such Licensed Product in the Field in the Territory; provided, that, Ares may retain a copy of such items for its records; and (ii) notify the applicable Regulatory Authorities in the Territory and other actions reasonably necessary to effect the transfer in subsection (i) above, including upon Deltas request, providing a right of reference to any regulatory materials or Regulatory Approvals Controlled by Ares on the effective date of termination, to the extent necessary for Delta to Develop and Commercialize the relevant Licensed Products; |
13.8.8 |
Unless prohibited by any Regulatory Authority, and subject to any Third Party consents, Ares shall, at the request of Delta, on a clinical trial-by-clinical trial basis, either (i) at Delta sole cost and expense transfer sponsorship and control to Delta of each clinical trial of the relevant Licensed Products being conducted in the Territory as of the effective date of termination or (ii) at Ares cost, wind down such clinical trial as soon as reasonable possible following the effective date of termination, whereby it is understood that the licenses granted under this Agreement shall remain in place for such a purpose; |
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13.8.9 |
In the event that Delta has requested the transfer of a clinical trial pursuant to Section 13.8.8 Ares shall assign or amend at Deltas cost and expense, as appropriate, any agreements with Third Parties that Ares has in place with respect to the conduct of such clinical trial for the relevant Licensed Products or the manufacture of the relevant Licensed Products (including agreements with contract manufacturing organizations, contract research organizations, clinical sites and investigators), or, to the extent any such Third Party agreement is not assignable to Delta, to cooperate with Delta to arrange to continue to provide such services for a reasonable time after termination and to facilitate Deltas entry into a replacement agreement with such Third Party for such services; |
13.8.10 |
Ares shall, on Deltas written request, supply to Delta Aress inventory of such Licensed Product at a price equal to [***] of Aress direct costs for such inventory of the Licensed Product; |
13.8.11 |
If Ares has Manufactured, is Manufacturing or is having manufactured the relevant Licensed Products or any intermediate of such Licensed Products as of the date of termination, Ares shall (i) transfer copies of documents and materials Controlled by Ares and embodying Know How or Patents Controlled by Ares that are at the time of such termination being used by Ares or its Third Party manufacturers to Manufacture the relevant Licensed Products, including but not limited to all suppliers, analytical methods, quality standards, specifications, commercial API formula, process chemistry, manufacturing process descriptions, process flows, cycle times, process parameters, process equipment type and sizes, cleaning methods, commercial API samples, master safety data sheets, and stability reports (the Ares Manufacturing Know-How), at Deltas cost, to enable the Manufacture of the relevant Licensed Products by Delta, its Affiliates or any Third Party manufacturer of Delta; (ii) provide technical assistance in the transfer of Ares Manufacturing Know-How to Delta, at Deltas cost; and (c) cooperate in the continuation of such manufacturing services for a [***] period after termination, subject to Delta reimbursing Ares reasonable out of pocket costs; |
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13.8.12 |
The Parties shall negotiate within a period of [***], any other applicable terms for a plan for the orderly transition of Development and Commercialization activities from Ares to Delta in a manner consistent with Applicable Law; and |
13.8.13 |
Section 9.2.8(b) shall not apply to the F-star Parties, and except as set forth in Section 9.6, each Party shall return or cause to be returned to the other Party all Confidential Information and all substances or compositions of the other Party or its Affiliates delivered or provided by or on behalf of such other Party, as well as any other material provided by or on behalf of such other Party in any medium, in connection with the relevant Subject mAb2 or Licensed Products for which this Agreement has been terminated. |
13.9 |
Effects of Termination by Ares with cause. In the event of a termination of this Agreement in respect of a Licensed Product by Ares pursuant to Section 13.4.1, the following terms and conditions will apply in respect of the relevant Licensed Product and Subject mAb2: |
(a) |
The relevant Subject mAb2 and Licensed Product shall cease to be Subject mAb2 and Licensed Products for the purposes of this Agreement; |
(b) |
All rights and licenses granted by Ares relating to the relevant Subject mAb2 or Licensed Products hereunder shall immediately terminate and Delta will have no further rights to use any Ares IP to Exploit the relevant Subject mAb2 or Licensed Products for which this Agreement has been terminated; |
(c) |
Ares rights and obligations in respect of the Development of the relevant Subject mAb2 or Licensed Products shall terminate; and |
(d) |
Unless prohibited by any Regulatory Authority, and subject to any Third Party consents, Ares shall, at the request of Delta, on a clinical trial-by-clinical trial basis, either (i) at Delta sole cost and expense transfer sponsorship and control to Delta of each clinical trial of the relevant Licensed Products being conducted in the Territory as of the effective date |
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of termination or (ii) at Delta cost, wind down such clinical trial as soon as reasonable possible following the effective date of termination, whereby it is understood that the licenses granted under this Agreement shall remain in place for such a purpose; |
(e) |
In the event that Delta has requested the transfer of a clinical trial pursuant to Section 13.9(d) Ares shall assign or amend at Deltas cost and expense, as appropriate, any agreements with Third Parties that Ares has in place with respect to the conduct of such clinical trial for the relevant Licensed Products or the manufacture of the relevant Licensed Products (including agreements with contract manufacturing organizations, contract research organizations, clinical sites and investigators), or, to the extent any such Third Party agreement is not assignable to Delta, to cooperate with Delta to arrange to continue to provide such services for a reasonable time after termination and to facilitate Deltas entry into a replacement agreement with such Third Party for such services; |
(f) |
Ares and its Affiliates and Sublicensees shall be entitled, during the[***] following such termination, to sell any commercial inventory of such Licensed Product(s) which remains on hand as of the date of the termination without any payment of royalties. |
(g) |
All rights and licenses granted by Ares to Delta in Section 5.4 relating to the relevant Subject mAb2 or Licensed Product shall immediately terminate and Section 9.2.8(b) shall not apply to the F-star Parties. |
13.10 |
Immediately following Ares notification of termination to Delta pursuant to Sections 13.3 or 13.4, the diligence obligations in Section 4.2 shall no longer apply and Ares shall have the right to wind-down all then on-going Development, Manufacturing and/or Commercialization activities. |
13.11 |
[***] |
13.11.1 |
[***] |
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13.11.2 |
the calculation of net sales shall be on the same basis as set out in the definition of Net Sales and the payment of the royalties shall be subject to the provisions of Section 7.4 through 7.13 (with [***] being substituted by [***] in Section 7.6) and |
13.11.3 |
the references to Licensed Patent in the definition of Royalty Term shall be a reference to the relevant Delta Patent that claims the composition of matter or method of use in the Field of the relevant Subject mAb2; |
Ares (for itself and its Affiliates) shall grant to Delta (without any further action required on the part of Ares):
(a) |
an irrevocable, perpetual exclusive license, with the right to grant sublicenses [***] under Ares Post-Data Package Improvements reasonably necessary or useful for the Exploitation, and for the sole purpose of Exploiting, the relevant Subject mAb2 or Licensed Products; and |
(b) |
an irrevocable, perpetual non-exclusive license, with the right to grant sublicenses through multiple tiers, under the Ares Background Know-How, Ares Background Patents, reasonably necessary or useful for the Exploitation, and for the sole purpose of Exploiting, the relevant Subject mAb2 or Licensed Products. |
13.12 |
Sublicenses. Upon any termination of this Agreement, Ares shall have the right but not the obligation to provide a list of its Sublicensees, which it proposes should continue to have the rights and license set forth in its sublicense agreements, and subject to a review of the terms of such sublicense agreements Delta may decide in its absolute discretion which, if any, agreements shall be assigned to Delta. |
13.13 |
Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
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13.14 |
Accrued Rights; Surviving Obligations. Termination or expiration of this Agreement in respect of a Subject mAb2 or Licensed Product for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party in respect of such in respect of such Subject mAb2 or Licensed Product prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, in respect of the termination or expiration of a Subject mAb2 or Licensed Product, the following Sections shall survive such termination or expiration: ARTICLE 1, Section 3.6, ARTICLE 7, Section 8.1, ARTICLE 9, Sections 12.1 to 12.5, 13.7 to 13.14, 14.1 and 14.4 to 14.15. |
ARTICLE 14
MISCELLANEOUS
14.1 |
Performance and Exercise by Affiliates. To the extent not limited by Section 3.5 each Party shall have the right to exercise its rights and perform its obligations hereunder through its Affiliates (including by licensing rights hereunder where such rights are held in the name of any such Affiliate); provided that such Party shall be responsible for its Affiliates performance hereunder; provided, further, that to the extent a Party exercises its rights and perform its obligations hereunder through its Affiliates, such arrangements shall be conducted on customary, arms-length terms (unless otherwise provided for in this Agreement) and in a manner that does not give rise to an agency relationship between a Party and any of its Affiliates performing obligations hereunder. |
14.2 |
Force Majeure. Neither Ares nor any of the F-star Parties shall be held liable or responsible to the other or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, |
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shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes or lockouts (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within [***] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimise its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use its Commercially Reasonable Efforts to remedy its inability to perform. If the force majeure continues for more than [***] from the receipt of notice by the other Party, Ares (if an F-star Party is the non-performing Party) or Delta (if Ares is the non-performing Party) shall have the right to terminate this Agreement on written notice. |
14.3 |
Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United Kingdom, Germany or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export licence or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law. |
14.4 |
Assignment. |
14.4.1 |
Without the prior written consent of Ares (if the requesting Party is an F-star Party) or Delta (if the requesting Party is Ares), such consent not to be |
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unreasonably withheld, conditioned or delayed, no Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided that a Party may make such an assignment without the other Parties consent to (a) [***]; (b) [***]; or (c) [***] provided in each case that the other Party shall be under no greater obligation or liability under this Agreement than if the assignment had never occurred. With respect to any such assignment, the assigning Party shall remain responsible for the performance by such assignee or transferee of the obligations hereunder. Any attempted assignment or delegation in violation of this Section 14.4 shall be void and of no effect. All validly assigned and delegated rights of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of F-star, Beta or Delta, as the case may be. Without limiting the foregoing, the grant of rights to the assigning Party set forth in this Agreement shall be binding upon any successor or permitted assignee of the assigning Party, and the obligations of the other Parties, including the payment obligations, shall run in favour of any such successor or permitted assignee of the assigning Partys benefits under this Agreement. |
14.4.2 |
Notwithstanding anything to the contrary herein, in the event of the acquisition of a controlling (as such term is used in the definition of Affiliate) interest in Beta, F-star, F-star GmbH, Delta or FTL, the acquirer of such Person shall not be considered to be an Affiliate of such Person for the purposes of this Agreement including for the purposes of the definition Control in respect of the intellectual property of the Parties or Section 5.1. For clarity (and without limitation), any Know-How, Patents or other intellectual property rights or other assets owned or Controlled by an acquirer or its Affiliates before such an acquisition of such Person or which were subsequently generated by the acquirer, or an Affiliate of the acquirer which is not Beta, F-star, Delta, F-star GmbH or FTL or an Affiliate of any of them immediately prior to the acquisition, will not be Controlled by such Person after such change in Control for purposes of this Agreement or |
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subject to Section 5.1, except to the extent that Beta, F-star, Delta, F-star GmbH or FTL or any of their respective Affiliates owned or Controlled such Know-How, Patents or other intellectual property rights or other assets before such acquisition. |
14.4.3 |
In the event of a change of control of Delta by a company that has in development a bispecific antibody that binds to the same Target pair as a Subject mAb2 then, within [***] of Delta informing Ares of such Change of Control Ares may, with [***] written notice to Delta, take over all of the Delta Development activities performed under each of the then ongoing Preclinical Development Plans and in such circumstances (i) the JSC shall immediately disband and (ii) the F-star Parties shall adopt reasonable procedures to prevent the disclosure of any Ares Confidential Information or any Delta Know-How that relates solely to a Subject mAb2 being disclosed to the acquirer of Delta. |
14.5 |
Severability. If any provision of this Agreement (or part of a provision) is held to be illegal, invalid, or unenforceable under any present or future law by any court or administrative body of a competent jurisdiction, and if the rights or obligations of any Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect. |
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14.6 |
Successors. The rights and obligations of the Parties under this Agreement shall continue for the benefit of, and shall be binding on, their respective successors and permitted transferees. |
14.7 |
Governing Law, Jurisdiction and Service. |
14.7.1 |
Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England and Wales, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. The parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods. |
14.7.2 |
Service. A document which starts or is otherwise required to be served in connection with any legal action or proceedings relating to a Dispute may be served in the same way as notices in accordance with Section 14.9. This Section 14.7.2 does not prevent any such document being served in another manner permitted by law. |
14.8 |
Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 2.7, if a claim, dispute or matter of difference arises between the Parties in any way whatsoever out of or in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (including claims for set-off or counterclaims) or the legal relationships established by this Agreement (a Dispute), it shall be resolved pursuant to this Section 14.8. |
14.8.1 |
General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within [***] (or such other period of time as mutually agreed by the Senior Officers) after such issue was first referred to them, then either Party may elect to initiate litigation in accordance with Section 14.8.2. |
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14.8.2 |
Litigation. Should the informal resolution mechanism of Section 14.8.1 prove unsuccessful within the allotted period, then the English courts shall have exclusive jurisdiction to settle any Dispute. Each Party agrees not to raise any challenges to such jurisdiction on the grounds of forum non conveniens. |
14.8.3 |
Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 14.8 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party. This Section shall be specifically enforceable. |
14.9 |
Notices. |
14.9.1 |
Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall sent by email to the relevant address in Section 14.9.2 and in each case it shall be sent for the attention of the relevant Party set out in Section 14.9.2 (or as otherwise notified from time to time in accordance with the provisions of Section 14.9.3). Any notice sent by email in accordance with this Section 14.9.1 shall be deemed to have been duly given when sent provided (i) a read receipt from each of the notice recipients has been received by the sender and (ii) a copy of the notice is sent by overnight courier to the postal address of the relevant Party (as set out in Section 14.9.2 below or as otherwise notified from time to time in accordance with the provisions of Section 14.9.3) on the same Business Day as the sending of the email, and provided further that if the sender of the email does not receive a read receipt from each of the notice recipients or receives an automated response from the recipient or a mail server indicating that the |
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recipient is out of office or that the email could not be delivered such notice shall be deemed delivered on the second Business Day after being deposited with the overnight courier. This Section 14.9.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. |
14.9.2 |
Address for Notice. |
If to Ares, to:
[***]
with a copy (which shall not constitute notice) to:
[***]
If to Delta to:
F-star Delta Ltd.
Eddeva B920 Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Legal Department
Email to all of: [***]
If to Beta to:
F-star Beta Ltd.
Eddeva B920 Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Legal Department
Email to all of: [***]
If to F-star to:
F-star Biotechnology Ltd.
Eddeva B920 Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Legal Department
Email to all of: [***]
If to F-star GmbH to:
F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H.
Eddeva B920 Babraham Research Campus
Cambridge, CB22 3AT
UK
Attention: Legal Department
Email to all of: [***]
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14.9.3 |
A Party may notify the other Parties of a change to its name, relevant addressee or address for the purposes of this Section 14.9, provided that such notice shall only be effective on: |
(a) |
the date specified in the notice as the date on which the change is to take place; or |
(b) |
if no date is specified or the date specified is less than [***] after the date on which notice is given, the date following [***] after notice of any change has been given. |
14.10 |
Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby (including (i) the Confidential Disclosure Agreement between Merck KGaA and F-star dated 12 May 2016 as amended on 9 May 2017; provided that (a) all Confidential Information disclosed or received thereunder will be deemed Confidential Information hereunder and will be subject to the terms and conditions of this Agreement, and (b) all rights and obligations under such agreement will otherwise continue in full force and effect as provided therein. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorised representatives of both Parties. |
14.11 |
English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. |
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14.12 |
Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise and does not affect its rights in relation to any other Party. No single or partial exercise of any such right or remedy under this Agreement shall preclude or restrict the further exercise of any such right or remedy. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein. |
14.13 |
No Benefit to Third Parties. Except as provided in ARTICLE 12, a person who is not a party to this Agreement has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce this Agreement. |
14.14 |
Further Assurance. Each party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement. |
14.15 |
Relationship of the Parties. It is expressly agreed that Delta, on the one hand, and Ares, on the other hand, shall be independent contractors and that the relationship between the parties shall not constitute a partnership, |
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joint venture, or agency, including for tax purposes. Neither Delta, on the one hand, nor Ares, on the other hand, shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a party shall be employees of such party and not of the other party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such party. |
14.16 |
Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument and which shall have the same effect as if each such Party had signed the same document. This Agreement may be executed by facsimile or electronically transmitted signatures and such signatures shall be deemed to bind each party hereto as if they were original signatures. |
SIGNATURE PAGES FOLLOW.
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IN WITNESS of which this Agreement has been duly executed as a deed and delivered on the Effective Date.
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EXECUTED as a deed by F-STAR | ) | |||||
BIOTECHNOLOGY LIMITED | ) | |||||
acting by: | ) | |||||
) | ||||||
in the presence of: | ||||||
Director/Authorised signatory | ||||||
Witness signature | ||||||
Witness address | ||||||
EXECUTED as a deed by F-STAR DELTA | ) | |||||
LIMITED | ) | |||||
acting by: | ) | |||||
) | ||||||
in the presence of: | ||||||
Director/Authorised signatory | ||||||
Witness signature | ||||||
Witness address |
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EXECUTED as a deed by F-STAR | ) | |||||
BIOTECHNOLOGISCHE | ) | |||||
) | ||||||
FORSCHUNGS-UND | ) | |||||
ENTWICKLUNGSGES.M.B.H | ||||||
acting by: | ||||||
in the presence of: | ||||||
Director/Authorised signatory | ||||||
Witness signature | ||||||
Witness address |
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Schedule 1.23
Beta Patents
Country |
Application Number |
Application
Date |
Status | Title | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] |
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Schedule 1.47
[***]
Country |
Application
Number |
Application
Date |
Status | Title | ||||
[***] |
[***] | [***] | [***] | [***] |
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Schedule 1.75
[***]
Country Code |
Application
Number |
Application
Date |
Status | Title | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] |
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[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] |
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[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] | ||||
[***] |
[***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
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[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | [***] | ||||
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Schedule 1.118
Preclinical Program Development Plan
[***]
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Schedule 1.128
Subject mAb2
Project code |
Fcab target | Fab target | ||
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Schedule 3.5
Approved Subcontractors
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Schedule 7.1
Option Exercise Fee
Program |
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Schedule 7.2
Research and Development Costs
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Schedule 7.3
Milestone Payments
Development Milestone Payments
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Schedule 9.4
Press Release
(see following page)
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F-star expedites its transition to a wholly-owned portfolio strategy
|
Reconfigured collaboration represents major advancement in F-stars pivot to a wholly-owned portfolio strategy |
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F-star retains lead clinical asset, first-in-class bispecific antibody, FS118 |
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FS118 Phase 1 trial study continues according to F-star protocol |
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Merck exercises option for one discovery stage programme and retains option for second discovery programme from original collaboration |
Cambridge, UK, 14 May 2019 F-star, a clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy, today announced the reconfiguration of its immuno-oncology collaboration, established in 2017, with Merck KGaA, Darmstadt, Germany as it executes on its transition to a wholly-owned portfolio and builds scale and value as a world-class biopharmaceutical company.
Under the terms of the new agreement, F-star retains exclusive rights to develop and commercialise FS118, a clinical-stage tetravalent bispecific antibody. At the same time, Merck has exercised its option for one discovery stage programme and retains the right to option a second discovery programme from the 2017 original agreement. No financial terms of the agreement are being disclosed.
Eliot Forster, CEO of F-star, said: This new agreement reflects our pivot to building a wholly-owned pipeline, that allows for rapid progress into the clinic and secures greater long-term value from our products. With full rights to FS118, we have an opportunity to accelerate the development of this first- in-class medicine for a group of targeted cancer patients. We are also pleased to continue our long- term collaboration with Merck KGaA, Darmstadt, Germany by advancing assets from F-stars Modular Antibody TechnologyTM into their pipeline.
FS118 is a potential first-in-class tetravalent bispecific antibody for the treatment of cancer, developed to overcome tumour evasion mechanisms promoted by two molecules (LAG-3: Lymphocyte-Activation Gene 3 and PD-L1: Programmed Death-Ligand 1) with the potential to restore the natural ability of the immune system to fight cancer(1). Initiated in April 2018 under F-stars sponsorship, the Phase I trial (NCT03440437) continues as originally planned and is expected to read out during 2020.
(1) |
LAG-3/PD-L1 mAb² can overcome PD-L1-mediated compensatory upregulation of LAG-3 induced by single-agent checkpoint blockade. Faroudi et al. (March 2019) - Poster at the annual AACR meeting |
- ENDS -
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For further information, please contact:
For investor enquiries | For media enquiries | |
Lindsey Trickett VP Investor Relations & Communications +1 240 543 7970 lindsey.trickett@f-star.com |
Pierre Peotta Communications Manager +44 (0)1223 948 094 +44 (0)7392 080 279 pierre.peotta@f-star.com |
|
Consilium Strategic Communications Chris Gardner, Sue Stuart, David Daley Tel: +44 (0)20 3709 5700 E-mail: F-star@consilium-comms.com |
US Catherine London, US President Tel: +1 917-763-2709 E-mail: F-star@consilium-comms.com |
About F-star
F-star is a leading clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy. By developing medicines that seek to block tumour immune evasion, the Companys goal is to offer patients greater and more durable benefits than current immuno-oncology treatments. Through its proprietary tetravalent, bispecific antibody (mAb²) format, F-star is generating first- and best-in-class drug candidates with monoclonal antibody-like manufacturability. Building on the combined expertise of its world-class management team and scientific leadership, F-star is poised to deliver the next breakthrough immunotherapies for cancer patients.
Find out more at www.f-star.com. Connect with us via LinkedIn and Twitter
About FS118
Currently in a Phase I trial at four clinical sites in the United States, FS118 is a potentially first-in-class medicine for the treatment of resistant and refractory cancer. This tetravalent, bispecific antibody is developed to overcome tumour evasion mechanisms promoted by two highly immuno-suppressive molecules: LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1). By simultaneously blocking both inhibitory pathways, FS118 has preclinically demonstrated a potent anti- tumour growth activity(1) as well as a highly differentiated mechanism of action(2) when compared to checkpoint monotherapies alone or in combinations.
In April 2018, a Phase 1 clinical study started in patients who have progressed on or after a prior PD-1/PD-L1 containing therapy. Information about the trial is available on clinicaltrials.gov NCT03440437. FS118 is manufactured at 2000L scale using standard mAb manufacturing processes.
(1) |
Dual blockade of PD-L1 and LAG-3 with FS118, a unique bispecific antibody, induces CD8+ T cell activation and modulates the tumour microenvironment to promote anti-tumour immune responses. Kraman et al. (April 2018) - Poster at the annual AACR meeting |
(2) |
LAG-3/PD-L1 mAb² can overcome PD-L1-mediated compensatory upregulation of LAG-3 induced by single-agent checkpoint blockade. Faroudi et al. (March 2019) - Poster at the annual AACR meeting] |
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Schedule 9.5
Agreed Publications
[***]
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Schedule 11.2
Business Warranties of F-star Parties
1. |
All Licensed Patents existing as of the Effective Date are set forth in Schedules 1.93, 1.23, 1.47 and 1.75 hereto, and all Licensed Patents (i) are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law, and (ii) all applicable fees have been paid on or before the due date for such payments. |
2. |
Delta is the sole and exclusive owner of, or Controls, the Delta IP. |
3. |
Beta is the sole and exclusive owner of, or Controls, the Beta IP. |
4. |
F-star and/or F-star GmbH is the sole and exclusive owner of, or Controls, the F-star IP. |
5. |
Delta has the necessary rights under the Beta IP, Delta IP and F-star IP licensed to Ares under this Agreement to conduct each Preclinical Program Development Plan in the manner contemplated under this Agreement and the relevant development plans. |
6. |
The F-star Parties Know-How constitutes all Know-How owned or Controlled by the F-star Parties as of the Effective Date that is directly related to, or are necessary or useful for, the research, Development, Manufacture, use or Commercialization of the Subject mAb² and Licensed Product. |
7. |
There are no written claims, judgments, or settlements against, or amounts with respect thereto, owed by an F-star Party or any of their respective Affiliates, relating to (i) the Licensed Patents existing as of the Effective Date, or (ii) the Delta IP. No written claim or litigation has been brought or threatened by any Person alleging that (a) the Licensed Patents existing as of the Effective Date are invalid or unenforceable, or (b) Licensed Patents existing as of the Effective Date, or the Delta IP, or the disclosing, copying, making, assigning, or licensing of the Licensed Patents existing as of the Effective Date or the Delta IP as contemplated by this Agreement violates, infringes, misappropriates or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
8. |
Neither Delta, nor any of its Affiliates have previously assigned, transferred, conveyed or otherwise encumbered its right, title or interest in or to the Subject mAb2 and the Beta IP, Delta IP and F-star IP in a manner that would prevent (i) Delta from performing each Preclinical Program Development Plan in the manner contemplated under this Agreement; or (ii) Ares or its Affiliates, subcontractors, and Sublicensees from researching, Developing, Manufacturing or Commercializing Subject mAb² and Licensed Products or from otherwise exploiting its rights and licenses granted or assigned by Delta or any of its Affiliates hereunder. |
9. |
There are no pending claims, judgments or settlements against, or amounts owed to a Third Party by Delta or any of its Affiliates in connection with a claim, judgment or settlement, involving the Subject mAb2 or the Beta IP, Delta IP and F-star IP licensed by Delta to Ares under this Agreement and Delta has not received written notice threatening any such claims. |
10. |
To Deltas knowledge, all information disclosed to Ares by Delta relating to the Subject mAb2, the Beta IP, Delta IP and F-star IP and the materials and methods to be employed by Delta in the execution of the Preclinical Program Development Plans and this Agreement is, at the time of disclosure, accurate in all material respects. |
11. |
To Deltas knowledge, no person is infringing or threatening to infringe or misappropriate or threatening to misappropriate the Beta IP, Delta IP and F-star IP. |
12. |
Each person who has or has had any rights in or to any of the Subject mAb2 or the Beta IP, Delta IP and F-star IP in each case existing as of the Effective Date and owned by Delta, Beta and/or F-star has assigned and has executed, or will assign or execute, an agreement assigning its entire right, title and interest in and to such Intellectual Property to Delta, Beta or F-star (as the case may be) and as far as Delta is aware, each person who has or has had any rights in or to any Subject mAb2 or the Beta IP, Delta IP and F-star IP in each case existing as of the Effective Date and licensed to Delta, Beta or F-star (as the case may be) by a Third Party has assigned and has executed an agreement assigning its entire right, title and interest in and to such Subject mAb2 or Delta, Beta or F-star to such Third Party. |
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
13. |
Other than the Intellectual Property that is licensed or assigned by Delta to Ares in this Agreement and as disclosed in paragraph 9, Delta has not received any written notice of any Intellectual Property Controlled by a Third Party that would be infringed, either by Ares or Delta, in the course of conducting the Development activities contemplated by this Agreement, or the other Exploitation of any Subject mAb2 or Licensed Product as contemplated hereunder. To Deltas knowledge, the practice of the inventions as claimed in the F-star Patents in relation to the Subject mAb2 does not infringe any intellectual property rights of any Third Party |
14. |
To the best of its knowledge and belief without having conducted any special inquiry, Delta does not require any additional licenses or other intellectual property rights or other rights or consents from any of its Affiliates in order for Delta to conduct the Development activities contemplated to be conducted by Delta pursuant to the Preclinical Programs Development Plans hereunder. |
15. |
All research and development related to the Subject mAb² and Licensed Product prior to the Effective Date has been conducted in accordance with all Applicable Laws. |
16. |
The F-star Parties have obtained any and all relevant consents required to allow the grant of the licences contemplated by this Agreement and the Delta IP Licence. After giving effect to this Agreement and the Delta IP Licence, there exist no breaches, defaults or events which would (with the giving of notice, the passage of time or both) give rise to a breach, default or other right to terminate or modify any material contract. |
- 158
CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Schedule 11.2A
F-star Parties Disclosure Schedule
[***]
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CONFIDENTIAL
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Exhibit 10.37
July 29, 2020
F-Star Therapeutics, Ltd. (F-Star)
Eddeva B920
Babraham Research Campus
Cambridge CB22 3AT
UK
Re: |
Equity Commitment |
Ladies and Gentlemen:
Summary and Introduction
This commitment letter reflects our agreement to invest $ in F-Star, with the investment to close on the same day that F-Star becomes a publicly traded company by combining with a Nasdaq listed company. We understand that simultaneously with the execution of this commitment letter, F-Star, a private company, is signing an agreement to combine with a Nasdaq listed company. We further understand that after the combination, the F-Star management team will run the F-Star business as the Nasdaq listed public company, and that we, as investors in F-Star, will be issued shares of the combined Nasdaq listed company as a result. We note that this kind of business combination transaction is referred to as a reverse merger when the private and public companies are both U.S. entities. Since F-Star is a company registered under the laws of England and Wales, the transaction is structured as a share exchange, but the business outcome is same.
The business combination will require approval of the shareholders of the Nasdaq-listed company that F-Star will combine with, so the closing of both the investment that is contemplated by this commitment letter and the share exchange will occur only after such shareholder approval is obtained. Our investment will close immediately prior to the closing of the share exchange, and the issuance to us of shares of the Nasdaq-listed version of F-Star will be registered on Form S-4, so we will received so-called unrestricted stock when the financing and share exchange close. Our investment will not close if the share exchange is not approved by the Nasdaq-listed company shareholders, and in such a case no transfer of funds will be made.
Agreement
Reference is made to the Share Exchange Agreement dated as of the date hereof (as it may be amended from time to time, the Share Exchange Agreement), by and among Spring Bank Pharmaceuticals, Inc., a Delaware corporation (PubCo), F-Star Therapeutics, Ltd., a company registered in England and Wales (F-Star) and the F-Star equity holders listed on Schedule I of the Share Exchange Agreement (the F-Star Holders), pursuant to which the F-Star Holders shall exchange all of the capital stock of F-Star for shares of PubCo, with the result of F-Star becoming a wholly-owned subsidiary of PubCo (the Share Exchange). Capitalized terms used, but not defined herein, have the meanings ascribed to them in the Share Exchange Agreement.
This letter agreement is being delivered by the undersigned investor (the Investor) to F-Star in connection with the execution of the Share Exchange Agreement by PubCo, F-Star and the F-Star Holders. The Investor hereby confirms its irrevocable commitment, subject to the conditions set forth herein, to purchase, or cause a permitted assignee to purchase, immediately prior to the closing of the Share Exchange, ordinary shares of F-Star, par value £0.01 per share (Shares), having an aggregate purchase price equal to $ (the Equity Commitment), at a price per Share (the Per Share Price) equal to $35,000,000 (the Agreed Pre-Money Valuation) divided by the number of outstanding ordinary shares of F-Star, assuming the conversion of all outstanding preference shares and the exercise of all outstanding in-the-money options and warrants (the Fully-Diluted F-Star Capitalization), as of immediately prior to the closing of the Share Exchange. For illustrative purposes, the purchase price, if calculated based on the Fully-Diluted F-Star Capitalization as of the date hereof, would be $1.49, which equals $35,000,000 divided by 23,494,553 shares. Accordingly, the Per Share Price represents a $35,000,000 pre-money valuation of F-Star (calculated using the treasury stock method).
The Shares to be purchased by the Investor are referred to herein as the Investor Shares. The Investor acknowledges that F-Star intends to issue Shares to other investors immediately prior to the Effective Time as part of this financing (the Financing) and that the Equity Commitment is a component of the Financing. F-Star hereby confirms its commitment, subject to the conditions herein, to enter into the Equity Purchase Document (defined below) and issue and sell to Investor in the Financing the Investor Shares for an amount equal to the Equity Commitment at the Per-Share Price immediately prior to the closing of the Share Exchange. In the event that F-Star agrees, prior to the closing of the Share Exchange, to sell additional ordinary shares in the Financing at a pre-money valuation lower than $35 million (the Future Pre-Money Valuation), then the Agreed Pre-Money Valuation for purposes of this letter agreement shall become the Future Pre-Money Valuation; provided however, for the avoidance of doubt, that the issuance of additional 2019 Loan Notes in an aggregate principal amount of up to $3 million, as permitted pursuant to Section 5.2(b) of the Share Exchange Agreement, and the conversion of such notes, shall not cause a change in the Agreed Pre-Money Valuation.
Simultaneously with the Financing, our outstanding convertible notes will be converted into ordinary shares at a 20% discount to the Per Share Price (which would be $1.19 per share if the Financing price is $1.49 per share, as in the illustration above). The convertible notes have an 8% per year interest rate, and the convertible notes are estimated to have an aggregate value (including interest accrued) of $15,182,072.
The Investors obligation to enter into the Equity Purchase Document and fund the Equity Commitment is subject only to (i) the execution and delivery of the Share Exchange Agreement; (ii) the conditions precedent to the Share Exchange being met or waived; and (iii) the terms of this letter agreement.
The Investor and F-Star hereby covenant to enter into a Subscription Agreement in the form of Exhibit A hereto (the Equity Purchase Document), which agreements shall (i) set forth the terms on which the Investor (or its successors or permitted assigns) shall purchase the Investor Shares for an amount equal to the Equity Commitment at the Per Share Price immediately prior to the closing of the Share Exchange, (ii) provide that upon the closing of the
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Share Exchange, the Investor Shares shall be sold to PubCo in consideration for such number of shares of PubCo common stock as is equal to the Exchange Ratio, rounded to the nearest whole share, pursuant to Section 1.4(a) of the Share Exchange Agreement (the Public Shares); (iii) provide that the issuance of the Public Shares to the Investor shall be registered on the Form S-4 filed pursuant to Section 6.1(a) of the Share Exchange Agreement; and (iv) include other customary terms and conditions; provided, that, in no event shall the obligation of the Investor to purchase the Investor Shares be conditioned by the completion by the Investor of its due diligence investigation with respect to the Equity Commitment.
The Investor represents and warrants that (i) it has the requisite power, capacity and authority to execute and deliver this letter agreement and to fulfill and perform its obligations hereunder; (ii) this letter agreement has been duly and validly executed and delivered by the Investor and constitutes a legal, valid and binding agreement of the Investor and is enforceable in accordance with its terms (subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or other similar laws affecting creditors rights generally and general equitable principles whether considered in a proceeding in law or in equity); (iii) the execution, delivery and performance of this letter agreement by the Investor has been duly and validly authorized and approved by all necessary corporate, limited partnership or similar action by such party; (iv) the Investor has available, unrestricted cash (or the unrestricted right (subject only to the giving of any required notices) to obtain from its investors funds) sufficient to pay and perform in full its obligation under this letter agreement to pay the Equity Commitment, which funds shall remain available to the Investor for so long as this letter agreement shall remain in effect; (v) the Investor has received and reviewed (or has had sufficient opportunity to review) this letter agreement (including the forms of Equity Purchase Document attached hereto) with independent legal, accounting and financial advisors regarding the Investors rights and obligations and the Investor fully understands the terms and conditions contained, and the transactions provided for, herein and therein; and (vi) the Investor understands that, while the Investor Shares will be exchanged for the Public Shares as part of the closing of the Share Exchange that will immediately follow the purchase of the Investor Shares, the issuance of the Investor Shares pursuant to the Equity Purchase Document will be a private placement exempt from registration under Section 4(a)(2) and Regulation D under the Securities Act and that such exemption shall rely, in part, on the representations and warranties of the Investor included in the following paragraph of this letter agreement and the Equity Purchase Document.
The Investor further acknowledges and represents that (i) the Investor Shares will be restricted securities and will not, at the time of issuance, have been registered under the Securities Act or any applicable state securities law (though the Investor Shares will be exchanged for the Public Shares at the closing of the Share Exchange, which shall take place seconds after the purchase of the Investor Shares); (ii) the Investor is acquiring the Investor Shares as principal for its own account and not with a view to, or for, distributing or reselling the Investor Shares or any part thereof in violation of the Securities Act or any applicable state securities laws; (iii) the Investor does not presently have any agreement, plan or understanding, directly or indirectly, with any Person to distribute or effect any distribution of any of the Securities (or any securities which are derivatives thereof) to or through any person or entity; (iv) the Investor will acquire the Investor Shares in the ordinary course of its business; (v) the Investor is not a registered broker-dealer under Section 15 of the Securities Exchange Act of 1934, as amended, or an entity engaged in a business that would require it to be so registered as a broker-dealer; (vi) the
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Investor is, at the date hereof, an accredited investor as defined in Rule 501(a) under the Securities Act; (vii) the Investor will not be purchasing the Investor Shares as a result of any advertisement, article, notice or other communication regarding the Investor Shares published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general advertisement; (viii) the Investor, either alone or together with its representatives, has such knowledge, sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Investor Shares, and has so evaluated the merits and risks of such investment; (ix) the Investor is able to bear the economic risk of an investment in the Investor Shares and, at the present time, is able to afford a complete loss of such investment; (x) the Investor acknowledges that it has reviewed publicly available materials relating to F-Star and the PubCo and has been afforded (a) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of F-Star and PubCo concerning the terms and conditions of the offering of the Investor Shares and the merits and risks of investing in the Investor Shares, (b) access to information about F-Star, PubCo and their subsidiaries and their respective financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (c) the opportunity to obtain such additional information that F-Star and PubCo possess or can acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to the investment; and (xi) the Investor has sought such accounting, legal and tax advice as it has considered necessary to make an informed decision with respect to its commitment to acquire the Investor Shares.
The Investor acknowledges and agrees that PubCo may, on or after the date hereof, issue a press release disclosing the material terms of the transactions contemplated by this letter agreement and may, on or after the date hereof, file a Current Report on Form 8-K describing the terms of this letter agreement and including the press release and a copy of this letter agreement and form of the Equity Purchase Document, as exhibits thereto or a subsequent periodic report, with the SEC.
This letter agreement shall be binding solely on, and inure solely to the benefit of, each of the undersigned and their respective successors and permitted assigns. The Investor may not assign the Equity Commitment to any third party, provided, that the Investor may assign all or a portion of its obligations to fund the Equity Commitment to its affiliates or affiliated funds or, with the prior written consent of F-Star, to any third party (without consideration therefor); provided, however, that the Investor shall remain liable for the Equity Commitment.
The parties hereto agree that irreparable damage would occur if any provision of this letter agreement were not performed in accordance with the terms hereof and that F-Star or the Investor, as the case may be, shall be entitled to an injunction or injunctions to prevent breaches of this letter agreement or to enforce specifically the performance of the terms and provisions hereof, in addition to any other remedy to which they are entitled at law or in equity. The parties hereto hereby agree not to raise any objections to the remedies of specific performance or other equitable relief to prevent or restrain breaches or threatened breaches of this letter agreement, and to specifically enforce the terms and provisions of this letter agreement to prevent breaches or threatened breaches of, or to enforce compliance with, the covenants and obligations of the Investor under this letter agreement.
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In the event that any suit or action is instituted with respect to this letter agreement, the prevailing party in such dispute shall be entitled to recover from the losing party all reasonable fees, costs and expenses of such prevailing party in connection with any such suit or action, including without limitation, such reasonable fees and expenses of attorneys and accountants, which shall include, without limitation, all reasonable fees, costs and expenses of appeals.
This letter agreement and any related dispute shall be governed by, and construed and interpreted in accordance with, the laws of the State of Delaware applicable to contracts executed in and to be performed in that State. Each of the parties hereto hereby (i) irrevocably submit to the personal jurisdiction of the Delaware Court of Chancery and any state appellate court therefrom within the State of Delaware (or, if the Delaware Court of Chancery declines to accept jurisdiction over a particular matter, any state or federal court within the State of Delaware) in the event that any dispute arises out of this letter agreement or any of the transactions contemplated by this letter agreement; (ii) agree that it will not attempt to deny or defeat such personal jurisdiction or venue by motion or other request for leave from any such court; and (iii) agree that it will not bring any action relating to this letter agreement or any of the transactions contemplated by this letter agreement in any court other than the Delaware Court of Chancery and any state appellate court therefrom within the State of Delaware (or, if the Delaware Court of Chancery declines to accept jurisdiction over a particular matter, any state or federal court within the State of Delaware).
EACH OF THE PARTIES HERETO HEREBY WAIVES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT TO ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS LETTER AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY.
This letter agreement may not be amended or otherwise modified without the prior written consent of F-Star and the Investor. This letter agreement may be executed in counterparts.
This letter agreement shall expire upon the earlier of (1) December 31, 2020 or (2) the termination of the Share Exchange Agreement in accordance with its terms. Nothing in this paragraph shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this letter agreement, the Equity Purchase Document or the Share Exchange Agreement or impair the right of any party to compel specific performance by any other party of its obligations under this letter agreement.
[Signature page follows]
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Sincerely, | ||
[INVESTOR] | ||
By: | ||
Its: | ||
By: |
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Name: | ||
Title: |
Accepted and agreed to as of the date first above written.
F-STAR THERAPEUTICS, LTD.
By: |
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Name: | ||
Title: |
EXHIBIT A
SUBSCRIPTION AGREEMENT
This SUBSCRIPTION AGREEMENT (this Agreement) is dated as of July [●], 2020 by and among F-Star Therapeutics Limited, a company registered in England and Wales with company number 11532458 (the Company), and each purchaser listed on Annex A hereto and a signatory hereto (each, including its successors and permitted assigns, a Purchaser and collectively, the Purchasers).
RECITALS
A. The Company and each Purchaser are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the U.S. Securities Act of 1933, as amended (the Securities Act), and Rule 506 of Regulation D (Regulation D) as promulgated by the United States Securities and Exchange Commission (the Commission) under the Securities Act.
B. Each Purchaser, severally and not jointly, wishes to subscribe for and purchase, and the Company wishes to issue and sell to each Purchaser, upon the terms and conditions stated in this Agreement, that number of ordinary shares of £0.01 each in the capital of the Company (the Ordinary Shares), determined as set forth in Section 2.1(a) below (which aggregate number for all Purchasers shall collectively be referred to herein as the Shares).
NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and each Purchaser hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Definitions. In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following terms shall have the meanings indicated in this Section 1.1:
Accounts means the annual accounts of the Company and each of its Subsidiaries in respect of each financial year ending on or after December 31, 2018.
Actual Subscription Amount with respect to a Purchaser shall mean the amount set forth opposite such Purchasers name under the column Actual Subscription Amount on Annex A.
Affiliate means, with respect to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Person, as such terms are used in and construed under Rule 144. With respect to a Purchaser, any investment fund or managed account that is managed on a discretionary basis by the same investment manager as such Purchaser will be deemed to be an Affiliate of such Purchaser.
Assignee means a person, company or entity who receives the transfer of property, title or rights from a contract.
Assignor means a person, company, or other entity who transfers rights that they hold to another entity.
Business Day means a day other than a Saturday, Sunday or other day on which commercial banks located in Boston, Massachusetts or London, England are authorized or required by applicable Legal Requirements to close; provided, however, for clarification, commercial banks shall not be deemed to be authorized or required by applicable Legal Requirements to close due to stay at home, shelter-in-place, non-essential employee or any other similar orders or restrictions or the closure of any physical branch locations at the direction of any Governmental Body so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in such location generally are open for use by customers on such day.
Claim means any claim for breach of any Company Warranty.
Closing means the closing of the purchase by the Purchasers listed on Annex A hereto and sale by the Company of the Shares to such Purchasers pursuant to this Agreement on the Closing Date as provided in Section 2.1(a) hereof.
Closing Date means the date on which the conditions set forth in Sections 2.1, 2.2, 5.1 and 5.2 (other than those to be satisfied at the Closing) shall have been satisfied or waived or such earlier or later date as the parties hereto shall mutually agree.
Commission has the meaning set forth in Recital A.
Company Counsel means Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. and Mills & Reeve LLP.
Company Deliverables has the meaning set forth in Section 2.2(a).
Company Warranties means the warranties given by the Company to the Purchaser as set forth in Section 3.1.
Companys Knowledge means with respect to any statement made to the knowledge of the Company, that the statement is based upon the actual knowledge of Eliot Forster, Ph.D., Darlene Deptula-Hicks and John Fitzpatrick, including where such individuals would reasonably be expected to have such actual knowledge in the ordinary course of the performance of such individuals employment or fiduciary capacity in relation to the Company, as applicable.
Compliance Certificate has the meaning set forth in Section 2.2(a)(i).
Disclosure Document has the meaning set forth in Section 6.19.
Disclosure Schedules has the meaning set forth in Section 3.2(a).
Disqualification Event has the meaning set forth in Section 3.1(j).
Encumbrance means any lien, pledge, hypothecation, charge, mortgage, security interest, encumbrance, claim, infringement, interference, option, right of first refusal, preemptive right, community property interest or restriction of any nature (including any restriction on the voting of any security, any restriction on the transfer of any security or other asset, any restriction on the receipt of any income derived from any asset, any restriction on the use of any asset and any restriction on the possession, exercise or transfer of any other attribute of ownership of any asset). For the avoidance of doubt, Encumbrance does not include Out Licenses.
End Date has the meaning set forth in the Share Exchange Agreement.
Exchange means the transaction whereby the Company, the Sellers and Spring Bank intend to effect a transaction whereby the Sellers contribute, transfer, assign and deliver all of the Ordinary Shares held by the Sellers, and all of their rights with respect to such Ordinary Shares, to Spring Bank, in exchange for Spring Bank Common Stock, resulting in the Company becoming a wholly-owned subsidiary of Spring Bank, in accordance with the terms and conditions set forth in the Share Exchange Agreement.
F-Star Disclosure Schedule has the meaning set forth in the Share Exchange Agreement.
GAAP means U.S. generally accepted accounting principles, as applied by the Company.
Governmental Authority means any court or tribunal, governmental, quasi-governmental or regulatory body, commission or authority or other body exercising similar powers or authority.
Governmental Body means any: (a) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental body of any nature (including any governmental division, department, agency, commission, instrumentality, official, ministry, fund, foundation, center, organization, unit, body or entity and any court or other tribunal, and for the avoidance of doubt, any Tax authority); or (d) self-regulatory organization (including NASDAQ and the Financial Industry Regulatory Authority).
IFRS means International Financial Reporting Standards, as applied by the Company.
Intellectual Property means copyright, neighboring and related rights, database rights, trade and service marks, trade names, rights in logos and get-up, goodwill and the right to sue for passing off or unfair competition, inventions, domain names, confidential information, trade secrets and know-how, registered designs, design rights, patents, utility models, semi-conductor topographies, all rights of whatsoever nature in computer software and data, all rights of privacy and all intangible rights and privileges of a nature similar or allied to any of the foregoing, in every case in any part of the world and whether or not registered; and including all granted registrations and all applications for registration in respect of any of the same but excluding any standard off the shelf software products.
IP Rights means all Intellectual Property owned, licensed, or controlled by the Company or its Subsidiaries that is necessary or used in the business of the Company and its Subsidiaries as presently conducted.
Legal Requirement means any national, federal, state, foreign, material local or municipal or other law, statute, directive, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Body.
Material Adverse Effect means any effect that, considered together with all other effects that have occurred prior to the date of determination of the occurrence of the Material Adverse Effect, has or would reasonably be expected to have or result in a material adverse effect on the business, financial condition, operations or results of operations of the Company and its Subsidiaries taken as a whole; provided, however, that effects from the following shall not be deemed to constitute (nor shall effects from any of the following be taken into account in determining whether there has occurred) a Material Adverse Effect: (i) conditions generally affecting the industries in which the Company participates or the United Kingdom, United States or global economy or capital markets as a whole, to the extent that such conditions do not have a disproportionate impact on the Company and its Subsidiaries, taken as a whole, relative to other companies in the industry in which the Company and its Subsidiaries operate; (ii) any failure by the Company or any of its Subsidiaries to meet any estimates or expectations of their development programs, internal projections or forecasts or third-party revenue or earnings predictions for any period ending (or for which revenues or earnings are released) on or after the date hereof (it being understood, however, that any effect causing or contributing to such failures to meet projections or predictions may constitute Material Adverse Effect and may be taken into account in determining whether a Material Adverse Effect has occurred); (iii) the execution, delivery, announcement or performance of the obligations under this Agreement, the Share Exchange Agreement or the announcement, pendency or anticipated consummation of the Exchange; (iv) any natural disaster or any acts of terrorism, sabotage, military action or war or any escalation or worsening thereof, or any viruses, pandemics, epidemic or other outbreak of illness or public health event or any spread or worsening thereof, or any other effect that may be considered a force majeure event; (v) any changes (after the date hereof) in IFRS or GAAP or applicable Legal Requirements (or, in each case, the interpretation thereof) to the extent that such conditions do not have a disproportionate impact on the Company or its Subsidiaries, taken as a whole, relative to other companies in the industry in which the Company and its Subsidiaries operate; (vi) the taking of any action, or the failure to take any action, by the Company or any of its Subsidiaries, that is required to comply with the terms of this Agreement or the Share Exchange Agreement; (vii) any changes in or affecting research and development, clinical trials or other drug development activities (including the failure to obtain positive results from clinical trials, the occurrence of adverse events or serious adverse events in any clinical trial, development activities or favorable responses from any applicable Governmental Body) conducted by or on behalf of the Company or any of its Subsidiaries or licensees in respect of the Companys products or product candidates; (viii) any rejection or non-acceptance by a Governmental Body of a registration or filing by the Company relating to any IP Rights of the Company; or (ix) regulatory approval of, or regulatory action or announcement with respect to, any product, or product candidates, of a third party that are similar to, or expected to compete against, any of the Companys product candidates.
Out License means any license or other agreement between Seller or any of its Affiliates and any Third Person pursuant to which Seller or any of its Affiliates grants to such Third Person an exclusive license or sublicense of, covenant not to sue under, or other similar rights under Product IP necessary for such Third Person to manufacture, use and commercialize a Product; provided, that Out Licenses shall exclude any agreement between Seller or any of its Affiliates and any Third Person pursuant to which Seller or any of its Affiliates grants to such Third Person a license or sublicense under the Product IP (a) to conduct research, or (b) on a non-exclusive basis in the ordinary course of business (e.g., manufacturing agreements, material transfer agreements and consulting agreements), that in all cases do not grant any rights to market, sell or commercialize a Product.
Ordinary Shares has the meaning set forth in Recital B.
Person means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, Governmental Authority or any other form of entity not specifically listed herein.
Product IP means Company IP relating to any or all of the products.
Purchaser Majority means the holders of 60% of the Shares.
Purchase Price means $● per Ordinary Share.
Regulation D has the meaning set forth in Recital A.
Required Approvals has the meaning set forth in Section 3.1(c).
Rule 144 means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such Rule.
Secretarys Certificate has the meaning set forth in Section 2.2(a)(ii).
Securities Act has the meaning set forth in Recital A.
Sellers means the sellers listed on Schedule I to the Share Exchange Agreement.
Shareholders Agreement means the Shareholders Agreement, dated May 7, 2019, a copy of which has been provided to each Purchaser (receipt of which each Purchaser hereby acknowledges).
Share Exchange Agreement means the Share Exchange Agreement to be entered into on or following the date of this Agreement, a copy of which has been provided to each Purchaser (receipt of which each Purchaser hereby acknowledges).
Shares has the meaning set forth in Recital B.
Share Certificates has the meaning set forth in Section 2.2(c)(ii).
Spring Bank means Spring Bank Pharmaceuticals, Inc., a Delaware corporation.
Spring Bank Common Stock means shares of common stock of Spring Bank, par value $0.0001.
Subsidiary means any entity in which the Company, directly or indirectly, owns a controlling interest in share capital or similar interest and Subsidiaries shall be construed accordingly.
Tax means any federal, state, local, foreign or other tax, including any income tax, franchise tax, capital gains tax, gross receipts tax, value-added tax, surtax, estimated tax, unemployment tax, national health insurance tax, excise tax, ad valorem tax, transfer tax, stamp tax, sales tax, use tax, property tax, business tax, withholding tax, payroll tax, customs duty, alternative or add-on minimum or other tax of any kind whatsoever, and including any fine, penalty, addition to tax or interest, whether disputed or not.
Third Person means a Person other than Assignor or Assignee.
Transaction Documents means this Agreement, the Secretarys Certificate and the Compliance Certificate.
ARTICLE 2
PURCHASE AND SALE
2.1 Closing.
(a) Amount. Subject to the terms and conditions set forth in this Agreement, at the Closing, the Company shall issue and sell to each Purchaser listed on Annex A hereto, as it may be amended, and each Purchaser listed on Annex A hereto, as it may be amended, shall, severally and not jointly, subscribe for and purchase from the Company, such number of Ordinary Shares equal to the quotient resulting from dividing (i) the Actual Subscription Amount for such Purchaser, as indicated opposite such Purchasers name on Annex A hereto, by (ii) the Purchase Price, rounded down to the nearest whole Ordinary Share (Subscription Shares).
(b) Closing. The Closing of the purchase and sale of the Shares shall take place at the offices of Company Counsel, One Financial Center, Boston, Massachusetts, on the Closing Date or at such other locations or remotely by facsimile transmission or other electronic means as the parties may mutually agree.
2.2 Closing Deliveries.
(a) On or prior to the Closing, the Company shall issue, deliver or cause to be delivered to each Purchaser the following (the Company Deliverables):
(i) a certificate of the Companys Secretary (the Secretarys Certificate), dated as of the Closing Date, (A) certifying the resolutions adopted by the Companys Board of Directors or a duly authorized committee thereof approving the transactions contemplated by this Agreement and the other Transaction Documents and the issuance of the Shares, (B) certifying the current versions of the Companys articles of association (as the same may have been amended between the date hereof and the Closing Date) and (c) certifying as to the signatures and authority of persons signing the Transaction Documents and related documents on behalf of the Company;
(ii) a certificate (the Compliance Certificate), dated as of the Closing Date and signed by the Companys Chief Executive Officer or its Chief Financial Officer, certifying to the fulfillment of the conditions specified in Sections 5.1(a) and 5.1(b); and
(iii) a certificate evidencing the good standing of the Company issued by the Registrar of Companies, as of a recent date of the Closing Date.
(b) At least five days before the Closing Date, each Purchaser shall, as payment to the Company for the issue and sale by the Company to that Purchaser of the relevant Subscription Shares, deliver its Actual Subscription Amount in U.S. dollars and in immediately available funds by wire transfer to an account specified by the Company; provided that if the Closing or Exchange is not consummated by 5:00 p.m., New York City time, on the End Date, the Company shall have no obligation to issue or sell the Subscription Shares to a Purchaser and, upon request by a Purchaser, the Company shall, within one (1) Business day thereof, return the Actual Subscription Amount (in U.S. dollars and in immediately available funds by wire transfer) paid by such Purchaser to an account specified by such Purchaser.
(c) On the Closing Date, a meeting (which may be done by written resolution) of the Board of Directors, or a committee thereof with delegated authority from the Board of Directors, shall be held at which the Company shall:
(i) subject to receipt of each Purchasers Actual Subscription Amount in accordance with Section 2.2(b), issue to each Purchaser the Ordinary Shares listed against its name in Annex A credited as fully paid and enter its name in the Companys register of members in respect thereof;
(ii) execute the Purchasers certificates in respect of their Ordinary Shares, free and clear of all restrictive and other legends except as provided in Section 4.1(b) hereof (the Share Certificates) which Share Certificates shall be held by the Company following the Closing, pending their cancellation by the Company upon closing of the Exchange. Upon closing of the Exchange, the Shares purchased pursuant to this Agreement will be treated as F-Star Shares (as defined in the Share Exchange Agreement), which will be converted into Spring Bank Common Stock in accordance with Section 1.4(a) of the Share Exchange Agreement;
(iii) pass any resolutions required to carry out the Companys obligations under this Agreement; and
(iv) instruct the Companys secretary to file all appropriate resolutions and forms with the Registrar of Companies within the prescribed time limits.
ARTICLE 3
WARRANTIES
3.1 Company Warranties. Subject to Section 3.2, the Company warrants to each of the Purchasers as follows:
(a) Authorization; Enforcement; Validity. The Company has the requisite corporate power under its articles of association to enter into and to consummate the transactions contemplated by each of the Transaction Documents to which it is a party and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of each of the Transaction Documents to which it is a party by the Company and the consummation by it of the transactions contemplated hereby and thereby (including, but not limited to, the sale and delivery of the Shares) have been, or will be prior to the Closing, duly authorized by all necessary corporate action on the part of the Company, and no further corporate action is required by the Company, its Board of Directors or its shareholders in connection therewith other than in connection with the Required Approvals. Each of the Transaction Documents to which it is a party has been (or upon delivery will have been) duly executed by the Company and is, or when delivered in accordance with the terms hereof, will, constitute the legal, valid and binding obligation of the Company enforceable against the Company in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally the enforcement of, creditors rights and remedies or by other equitable principles of general application or insofar as indemnification and contribution provisions may be limited by applicable Legal Requirements.
(b) No Conflicts. The Company is not in violation or default of any term of its constitutional documents, each as amended, or of any provision of any mortgage, indenture, contract, lease, agreement, instrument or contract to which it is party or by which it is bound or of any judgment, decree, order or writ, other than any such violation that would not have a Material Adverse Effect. The execution, delivery, and performance of and compliance with the Transaction Documents and the issuance and sale of the Shares pursuant to this Agreement will not, with or without the passage of time or giving of notice, result in any such violation, or be in conflict with or constitute a material default under any such term or provision, or result in the creation of any Encumbrance upon any of the properties or assets of the Company or the suspension, revocation, impairment, forfeiture or nonrenewal of any permit, license, authorization or approval applicable to the Company, its business or operations or any of its assets or properties.
(c) Filings, Consents and Approvals. The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any Governmental Authority or other Person in connection with the execution, delivery and performance by the Company of the Transaction
Documents (including the issuance of the Shares), other than (i) filings required by applicable state securities laws, (ii) the filing of a Notice of Sale of Shares on Form D with the Commission under Regulation D, (iii) those that have been made or obtained prior to the date of this Agreement and (v) those required to effect the Exchange (collectively, the Required Approvals).
(d) Issuance of the Shares. The Shares have been duly authorized and, when issued and paid for in accordance with the terms of the Transaction Documents, will be duly and validly issued, fully paid and free and clear of all Encumbrances imposed or permitted by the Company, other than restrictions on transfer provided for in the Transaction Documents, articles of association of the Company, Shareholders Agreement or imposed by applicable securities laws, and save as contained in the articles of association of the Company and the Shareholders Agreement, shall not be subject to preemptive or similar rights.
(e) Additional Warranties. The Companys warranties set forth in the Share Exchange Agreement in Section 2.1 (Organization and Qualification; Charter Documents), Section 2.2 (Capital Structure), Section 2.3 (Authority; Non-Contravention; Approvals), Section 2.4 (F-Star Financial Statements; No Undisclosed Liabilities), Section 2.5 (Absence of Certain Changes or Events), Section 2.6 (Taxes), Section 2.7 (Intellectual Property), Section 2.8 (Compliance with Legal Requirements), 2.9 (Legal Proceedings; Orders), Section 2.10 (Brokers and Finders Fees), Section 2.11 (Employee Benefit Plans), Section 2.12 (Title to Assets; Real Property), Section 2.13 (Environmental Matters), Section 2.14 (Labor Matters), Section 2.15 (F-Star Contracts), Section 2.16 (Books and Records), Section 2.17 (Insurance), Section 2.18 (Government Contracts), Section 2.19 (Interested Party Transactions), Section 2.20 (Disclosure; Company Information) and Section 2.21 (Ownership of Company Capital Stock) are hereby incorporated as warranties by reference and are qualified by (i) the disclosures in the F-Star Disclosure Schedule; and (ii) the qualifications and limitations contained in Section 3.2 of this Agreement, provided that for purposes of this Agreement any warranty as to the making available or delivery of documents to Spring Bank shall mean the making available or delivery of documents to each Purchaser.
(f) Certain Fees. Other than BTIG, LLC (BTIG) in its capacity as placement agent, no Person will have, as a result of the Companys issuance of the Shares pursuant to the terms of this Agreement, any valid right, interest or claim against or upon the Company or a Purchaser for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company. The Company shall indemnify, pay, and hold each Purchaser harmless against, any liability, loss or expense (including, without limitation, attorneys fees and out-of-pocket expenses) arising in connection with any such right, interest or claim.
(g) Private Placement. Assuming the accuracy of the warranties of the Purchasers contained in Section 3.3 hereof, the offer, sale and issuance of the Shares will be exempt from the registration requirements of the Securities Act, and will have been registered or qualified (or are exempt from registration and qualification) under the registration, permit or qualification requirements of all applicable state securities laws. Neither the Company nor any agent on its behalf has solicited or will solicit any offers to sell or has offered to sell or will offer to sell all or any part of the Shares to any person or persons so as to bring the sale of such Shares by the Company within the registration provisions of the Securities Act or any state securities laws. Assuming the accuracy of the Purchasers warranties set forth in Section 3.3 (without giving effect to any materiality qualifiers therein), neither the Company nor any Person acting on its behalf has, directly or indirectly, at any time within the past six months, made any offers or sales of any Company security or solicited any offers to buy any security under circumstances that would eliminate the availability of the exemption from registration under Regulation D in connection with the offer and sale by the Company of the Shares as contemplated hereby.
(h) Investment Company. The Company is not required to be registered as, and is not an Affiliate of, and immediately following the Closing and the Exchange will not be required to register as, an investment company within the meaning of the Investment Company Act of 1940, as amended.
(i) Foreign Corrupt Practices. Neither the Company, nor to the Companys Knowledge, any agent or other person acting on behalf of the Company, has: (i) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) made any unlawful payment to foreign or domestic government officials or employees or to any foreign or domestic political parties or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company (or made by any person acting on its behalf of which the Company is aware) which is in violation of law or (iv) violated in any material respect any provision of the Foreign Corrupt Practices Act of 1977, as amended.
(j) No Disqualification Events. The Company has exercised reasonable care, in accordance with Commission rules and guidance, to determine whether any Covered Person (as defined below) is subject to any of the bad actor disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act (Disqualification Events). To the Companys Knowledge, no Covered Person is subject to a Disqualification Event, except for a Disqualification Event covered by Rule 506(d)(2) or (d)(3) under the Securities Act. The Company has complied, to the extent applicable, with any disclosure obligations under Rule 506(e) under the Securities Act. Covered Persons are those persons specified in Rule 506(d)(1) under the Securities Act, including the Company; any predecessor or Affiliate of the Company; any director, executive officer, other officer participating in the offering, general partner or managing member of the Company; any beneficial owner of 20% or more of the Companys outstanding voting equity securities, calculated on the basis of voting power; any promoter (as defined in Rule 405 under the Securities Act) connected with the Company in any capacity at the time of the sale of the Shares; and any person that has been or will be paid (directly or indirectly) remuneration for solicitation of purchasers in connection with the sale of the Shares (a Solicitor), any general partner or managing member of any Solicitor, and any director, executive officer or other officer participating in the offering of any Solicitor or general partner or managing member of any Solicitor.
(k) Share Exchange Agreement. When executed and delivered, the Share Exchange Agreement will be in full force and effect and represents a valid, binding and enforceable obligation of the Company and, to the Companys Knowledge, of each party thereto, subject to the qualification that such enforceability may be limited by bankruptcy, insolvency, reorganization or other laws of general application relating to or affecting rights of creditors. The Company has no reason to believe that the Exchange will not occur promptly following the consummation of the transactions contemplated by this Agreement.
3.2 Qualifications to the Company Warranties and Limitation on Claims
(a) Qualifications to the Company Warranties. Except with respect to Company Warranties 3.1(a) and 3.1(d), the Company Warranties are given to the Purchasers subject to the qualifications and limitations set out in this Section 3.2 and the matters set forth in the disclosure schedules delivered by the Company to the Purchasers prior to the execution of this Agreement (receipt of which each Purchaser hereby acknowledges) (the Disclosure Schedules), it being agreed that:
(i) although for ease of reference the exceptions and disclosures set forth in the Disclosure Schedules correspond to a particular section or subsection of the Company Warranties, such exceptions and disclosures shall be taken as qualifying all Company Warranties to which such exceptions and disclosures may reasonably be considered applicable;
(ii) the following shall be considered disclosed or deemed disclosed in relation to the Company Warranties and no Claim may be brought in relation to any matter disclosed by the following:
(A) all matters contained in the Transaction Documents, the Share Exchange Agreement and the F-Star Disclosure Schedule;
(B) any matter appearing on the files of the Company at Companies House as the same appeared on the Companies House website at www.direct.companieshouse.gov.uk on the date falling two Business Days prior to the date of this Agreement;
(C) any matter appearing on public registers maintained by relevant intellectual property offices (including the UK Intellectual Property Office, European Patent Office, United States Patent and Trade Mark Office and WIPO);
(D) any matter appearing on any register which relates to any of the properties owned, used or occupied by the Company and which is open to public inspection (including at HM Land Registry);
(E) any matter or information disclosed, noted, referred to or provided for in the Accounts;
(F) any matter contained in the memorandum and articles of association of the Company;
(G) any matter which is or should be revealed by inspection of the statutory registers of the Company;
(H) all the contents of the diligence materials or documents provided or made available to the Purchasers.
(iii) the inclusion of any information in the Disclosure Schedules shall not be deemed to be an admission or acknowledgement, in and of itself, that such information is required by the terms hereof to be disclosed, is material, has resulted in or would result in a Material Adverse Effect, or is outside the ordinary course of business.
(b) Limitations on Claims.
(i) The limitations in this Section 3.2(b) shall not apply to any Claim which is the consequence of fraud, dishonesty, willful concealment or willful misrepresentation by or on behalf of the Company.
(ii) No Claim may be made against the Company unless written notice of such Claim is served on the Company giving full and specific details to enable the Company to identify the subject matter, nature and quantum of the Claim by no later than the Closing Date.
(iii) The aggregate liability of the Company in respect of all and any Claims shall be limited to an amount equal to the aggregate amount subscribed by the Purchasers pursuant to this Agreement.
(iv) The Company shall not be liable in respect of a Claim unless (a) the Companys liability in respect of such Claim exceeds £5,000; and (b) the aggregate liability for all Claims exceeds £50,000, in which case the Company shall be liable for the entire amount and not merely the excess over that amount.
(v) No liability of the Company in respect of any breach of any Company Warranty shall arise if such breach occurs by reason of any matter which would not have arisen but for the coming into force of any legislation not in force at the date of this Agreement or by reason of any change to the practices of any applicable Tax authority occurring after the date of this Agreement.
(vi) The Company shall not be liable for any Claim if the alleged breach, which is the subject of the Claim, is capable of remedy and is remedied to the reasonable satisfaction of the Purchaser within 30 days of the date on which the notice in Section 3.2(b)(ii) is received by the Company.
(vii) The Purchasers shall not be entitled to recover damages or otherwise obtain payment, reimbursement or restitution more than once in respect of the same loss or liability.
(viii) Nothing in this Agreement shall prejudice each Purchasers duty under common law to mitigate any loss or liability which is the subject of a Claim.
(ix) The Purchasers agree among themselves that the following provisions shall apply in relation to the enforcement of any of the obligations of the Company owed to the Purchasers under this Agreement (the Obligations):
(A) |
no claim in respect of any breach of the Obligations (including a Claim) shall be brought by any of the Purchasers without the prior written consent of the Purchaser Majority, provided that all Purchasers have been informed of the breach of the Obligations or proposed Claim and consulted prior to the Purchaser Majoritys decision being made; |
(B) |
the costs incurred by any Purchasers in bringing a claim in respect of any breach of the Obligations (including a Claim) shall be borne by all of the Purchasers proportionately to their holding of the Shares; and |
(C) |
the costs incurred by any Purchasers in bringing a claim in respect of any breach of the Obligations (including a Claim) shall be borne by all of the Purchasers proportionately to their holding of the Shares. |
3.3 Warranties of the Purchasers. Each Purchaser hereby warrants severally and not jointly to the Company as follows:
(a) Requisite Power and Authority. Such Purchaser has all necessary power and authority to execute and deliver the Transaction Documents to which it is a party and to carry out their provisions. All action on such Purchasers part required for the lawful execution and delivery of the Transaction Documents to which it is a party has been taken. Upon their execution and delivery, the Transaction Documents will be valid and binding obligations of such Purchaser, enforceable against such Purchaser in accordance with their respective terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors rights, (b) as limited by general principles of equity that restrict the availability of equitable remedies, and (c) to the extent that the enforceability of the indemnification provisions may be limited by applicable Legal Requirements.
(b) Investment Representations. Such Purchaser understands that the Shares have not been registered under the Securities Act. Such Purchaser also understands that the Shares are being offered and sold pursuant to an exemption from registration contained in the Securities Act based in part upon such Purchasers warranties contained in this Agreement. Such Purchaser hereby warrants as follows:
(i) Purchaser Bears Economic Risk. Such Purchaser has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company so that it is capable of evaluating the merits and risks of its investment in the Company and has the capacity to protect its own interests. Such Purchaser must bear the economic risk of this investment indefinitely unless the Shares are registered pursuant to the Securities Act, or an exemption from registration is available. Such Purchaser understands that the Company has no present intention of registering the Shares or any shares in its capital. Such Purchaser also understands that there is no assurance that any exemption from registration under the Securities Act will be available and that, even if available, such exemption may not allow such Purchaser to transfer all or any portion of the Shares under the circumstances, in the amounts or at the times such Purchaser might propose.
(ii) Acquisition for Own Account. Such Purchaser is acquiring the Shares for such Purchasers own account for investment only, and not with a view towards their distribution.
(iii) Purchaser Can Protect Its Interest. Such Purchaser warrants that by reason of its, or of its managements, business or financial experience, such Purchaser has the capacity to protect its own interests in connection with the transactions contemplated in the Transaction Documents. Further, such Purchaser is aware of no publication of any advertisement in connection with the transactions contemplated in the Agreement.
(iv) Accredited Investor. Such Purchaser warrants that it is an accredited investor within the meaning of Regulation D under the Securities Act.
(v) Company Information. Such Purchaser has received the applicable financial statements of the Company and has had an opportunity to discuss the Companys business, management and financial affairs with directors, officers and management of the Company. Such Purchaser has also had the opportunity to ask questions of and receive answers from, the Company and its management regarding the terms and conditions of this investment.
(vi) Rule 144. Such Purchaser acknowledges and agrees that the Shares are restricted securities as defined in Rule 144 promulgated under the Securities Act as in effect from time to time and must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Such Purchaser has been advised or is aware of the provisions of Rule 144, which permits limited resale of shares purchased in a private placement subject to the satisfaction of certain conditions, including, among other things: the availability of certain current public information about the Company, the resale occurring following the required holding period under Rule 144 and the number of shares being sold during any three-month period not exceeding specified limitations.
(vii) Bad Actor Matters. Such Purchaser hereby warrants that no Disqualification Events are applicable to such Purchaser or any of its Rule 506(d) Related Parties (as defined below), except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable; provided, however, that with respect to Roche Finance Ltd, such warrantee shall not apply to any of its Rule 506(d) Related Parties. Such Purchaser hereby agrees that it shall notify the Company promptly in writing in the event a Disqualification Event becomes applicable to such Purchaser or any of its Rule 506(d) Related Parties, except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable. For the purposes of this Section 3.3(b)(vii), Rule 506(d) Related Party shall mean a Person that is a beneficial owner of Purchasers securities for purposes of Rule 506(d) of the Securities Act.
(viii) Residence. If such Purchaser is an individual, then such Purchaser resides in the state or province identified in the address of such Purchaser set forth on Annex A; if such Purchaser is a partnership, corporation, limited liability company or other entity, then the office or offices of such Purchaser in which its investment decision was made is located at the address or addresses of such Purchaser set forth on Annex A.
(ix) Non-U.S. Investors. If such Purchaser is not a United States person (as defined by Section 7701(a)(30) of the U.S. Internal Revenue Code of 1986, as amended), or if such Purchaser is a U.S. subsidiary or Affiliate of a foreign parent company, (Non-U.S. Purchaser), such Purchaser hereby warrants that it has satisfied itself as to the full observance of the laws of its jurisdiction in connection with any invitation to subscribe for the Shares or any use of this Agreement, including (i) the legal requirements within its jurisdiction for the purchase of its proposed Ordinary Shares, (ii) any foreign exchange restrictions applicable to such purchase, (iii) any government or other consents that may need to be obtained, and (iv) the Tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale or transfer of such Ordinary Shares. Each Non-U.S. Purchaser further warrants that either (x) it does not now, nor will it after any Closing, hold 10% or greater, directly or indirectly, of the voting interest in the Company or (y) if it does or will, such Non-U.S. Purchaser shall notify the Company and shall provide such information as the Company may request to comply with U.S. state, federal, or local regulations. The Companys offer and sale and Non-U.S. Purchasers subscription and payment for and continued beneficial ownership of its proposed Ordinary Shares will not violate any applicable securities or other laws of Non-U.S. Purchasers jurisdiction.
(c) Brokers and Finders. No Person will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Company or any Purchaser for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of such Purchaser.
(d) Independent Investment Decision. Such Purchaser has independently evaluated the merits of its decision to purchase its Ordinary Shares pursuant to the Transaction Documents, and such Purchaser confirms that it has not relied on the advice of any other Purchasers business and/or legal counsel in making such decision. Such Purchaser understands that nothing in this Agreement or any other materials presented by or on behalf of the Company to such Purchaser in connection with the purchase of its Ordinary Shares constitutes legal, tax or investment advice. Such Purchaser has consulted such legal, tax and investment advisors as it, in its sole discretion, has deemed necessary or appropriate in connection with its purchase of its Ordinary Shares. Neither such inquiries nor any other investigation conducted by or on behalf of such Purchaser or its representatives or counsel shall modify, amend or affect such Purchasers right to rely on the truth, accuracy and completeness of the Companys warranties contained in the Transaction Documents (as qualified by this Agreement (including the Disclosure Schedules)).
(e) Reliance on Exemptions. Such Purchaser understands that the Shares are being offered and sold to it in reliance on specific exemptions from the registration requirements of United States federal and state securities laws and that the Company is relying in part upon the truth and accuracy of, and such Purchasers compliance with, the warranties, agreements, acknowledgements and understandings of such Purchaser set forth herein in order to determine the availability of such exemptions and the eligibility of such Purchaser to acquire their Ordinary Shares.
(f) No Governmental Review. Such Purchaser understands that no Governmental Authority has passed on or made any recommendation or endorsement of the Shares or the fairness or suitability of the investment in the Shares nor has any such authority passed upon or endorsed the merits of the offering of the Shares.
(g) FSMA Confirmation. Such Purchaser hereby confirms to the Company that it falls within one of the exemptions contained in the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended, relating to the experience or wealth of such Purchaser (such as are contained in articles 19(5), 48 or 49(2) of such Order).
The Company and each of the Purchasers acknowledge and agree that no party to this Agreement has made or makes any representations or warranties with respect to the transactions contemplated hereby other than those warranties specifically set forth in this Article 3 and the Transaction Documents.
ARTICLE 4
OTHER AGREEMENTS OF THE PARTIES
4.1 Transfer Restrictions.
(a) Compliance with Laws. Notwithstanding any other provision of the Transaction Documents, until the Shares are converted into Spring Bank Common Stock pursuant to Section 1.4(a) of the Share Exchange Agreement, each Purchaser covenants that its Ordinary Shares may be disposed of only:
(i) in accordance with the Companys articles of association (from time to time) and the terms of the Shareholders Agreement; and
(ii) pursuant to an effective registration statement under, and in compliance with the requirements of, the Securities Act, or pursuant to an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act, and in compliance with any applicable laws (including state and federal securities laws). In connection with any transfer of the Shares other than (i) pursuant to an effective registration statement or (ii) to the Company (where permitted by law), the Company may require the transferor thereof to provide to the Company an opinion of counsel selected by the transferor and reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred Ordinary Shares under the Securities Act. As a condition of transfer, any such transferee shall agree in writing to be bound by the terms of this Agreement and shall have the rights of a Purchaser under this Agreement.
(b) Legends. Share Certificates evidencing the Shares shall bear any legend as required by the Blue Sky laws of any state and a restrictive legend in substantially the following form until such time as they are not required under Section 4.1(c) (and a stock transfer order may be placed against transfer of the Share Certificates for the Shares):
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE ACT) AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, ASSIGNED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR UNLESS THE COMPANY HAS RECEIVED AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY AND ITS COUNSEL THAT SUCH REGISTRATION IS NOT REQUIRED.
In addition, if any Purchaser is an Affiliate of the Company, Share Certificates evidencing the Shares issued to such Purchaser shall bear a customary affiliates legend.
(c) Removal of Legends. Subject to the Companys right to request an opinion of counsel as set forth in Section 4.1(a), the legend set forth in Section 4.1(b) above shall be removable and the Company shall issue or cause to be issued a Share Certificate without such legend or any other legend (except for any affiliates legend as set forth in Section 4.1(b)) to the holder of the applicable Shares upon which it is stamped, if (i) such Shares are registered for resale and resold pursuant to an effective registration statement under the Securities Act, (ii) such Shares are sold or transferred in compliance with Rule 144 (if the transferor is not an Affiliate of the Company), including without limitation in compliance with the current public information requirements of Rule 144 if applicable to the Company at the time of such sale or transfer, and the holder and its broker have delivered customary documents reasonably requested by counsel to the Company in connection with such sale or transfer, or (iii) such Shares are eligible for sale under Rule 144 without the requirement that the Company be in compliance with the current public information requirements of Rule 144 and without other restriction and counsel to the Company has provided written confirmation of such eligibility to the Company. Any fees (with respect to the counsel to the Company or otherwise) associated with the removal of such legend shall be borne by the Company.
4.2 Form D and Blue Sky. The Company agrees to timely file a Form D with respect to the Shares as required under Regulation D and to provide a copy thereof to each Purchaser who requests a copy in writing promptly after such filing. The Company shall take such action as the Company shall reasonably determine is necessary in order to qualify the Shares for sale to the Purchasers at the Closing pursuant to this Agreement under applicable securities or Blue Sky laws of the states of the United States (or to obtain an exemption from such qualification), which, subject to the accuracy of the Companys and the Purchasers warranties set forth herein, shall consist of the submission of all filings and reports relating to the offer and sale of the Shares pursuant to Rule 506 of Regulation D required under applicable securities or Blue Sky laws of the states of the United States following the Closing Date, and shall provide evidence of any such action so taken to the Purchasers who request in writing such evidence.
4.3 No Integration. The Company has not and shall not, and shall use its commercially reasonable efforts to ensure that Spring Bank and the Affiliates of the Company and the Affiliates of Spring Bank shall not, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the sale of the Shares to the Purchasers.
4.4 Use of Proceeds. The Company intends to use the net proceeds from the sale of the Shares hereunder for general working capital.
ARTICLE 5
CONDITIONS PRECEDENT TO CLOSING
5.1 Conditions Precedent to the Obligations of the Purchasers to Purchase Shares at the Closing. The obligation of each Purchaser to acquire Shares at the Closing is subject to the fulfillment, on or prior to the Closing Date, of each of the following conditions:
(a) Warranties. The Company warranties are true and correct in all respects as of the date of this Agreement and are true and correct in all respects on and as of the Closing Date with the same force and effect as if made on the Closing Date, except (i) for those warranties which address matters only as of a particular date (which warranties were so true and correct as of such particular date); (ii) if the Company delivers a Supplemental Disclosure Schedule at or immediately prior to Closing, providing updated disclosures in respect of the intervening period following signing; and (iii) where the failure of those warranties would not have a Material Adverse Effect (disregarding all materiality qualifiers included in such warranties).
(b) Performance. The Company shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by this Agreement to be performed, satisfied or complied with by it on or prior to the Closing Date.
(c) No Injunction. No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any Governmental Authority of competent jurisdiction that prohibits the consummation of the sale of the Shares.
(d) Consents. The Company shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for consummation of the purchase and sale of the Shares at the Closing (except for the Required Approvals that may be obtained after the Closing), all of which shall be and remain so long as necessary in full force and effect.
(e) Company Deliverables. The Company shall have delivered the Company Deliverables in accordance with Section 2.2(a).
(f) Exchange. Each of the conditions to the consummation of the Exchange set forth in the Share Exchange Agreement shall have been satisfied or waived (if permissible under applicable Legal Requirements) and the parties to the Share Exchange Agreement shall be ready, willing and able to consummate the Exchange immediately after the Closing on the terms and conditions set forth therein.
(g) Termination. This Agreement shall not have been terminated as to such Purchaser in accordance with Section 6.17.
(h) Funding. The Actual Subscription Amount will have been released with respect to each other Purchaser in accordance with Section 2.2(b) or the Company shall have otherwise received proceeds in respect of the sale of the Shares equal to the aggregate of each Purchasers Actual Subscription Amount.
5.2 Conditions Precedent to the Obligations of the Company to sell Shares at the Closing. The Companys obligation to sell and issue the Shares to the Purchasers at the Closing is subject to the fulfillment on or prior to the Closing Date of the following conditions:
(a) Warranties. The warranties made by such Purchaser in Section 3.3 hereof shall be true and correct in all material respects (except for those warranties which are qualified as to materiality, in which case such warranties shall be true and correct in all respects) as of the date of this Agreement, and as of the Closing Date as though made on and as of such date, except for warranties that speak as of a different specified date (which warranties shall have been so true and correct as of such specified date).
(b) Performance. Such Purchaser shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the Transaction Documents to be performed, satisfied or complied with by such Purchaser on or prior to the Closing Date.
(c) No Injunction. No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any Governmental Authority of competent jurisdiction that prohibits the consummation of the sale of the Shares.
(d) Exchange. Each of the conditions to the consummation of the Exchange set forth in the Share Exchange Agreement shall have been satisfied or waived (if permissible under applicable Legal Requirements) and the parties to the Share Exchange Agreement shall be ready, willing and able to consummate the Exchange immediately after the Closing on the terms and conditions set forth therein.
(e) Termination. This Agreement shall not have been terminated as to such Purchaser in accordance with Section 6.17.
(f) Receipt of Funds. The Actual Subscription Amount with respect to each Purchaser shall have been received by the Company.
ARTICLE 6
MISCELLANEOUS
6.1 Fees and Expenses. The Company and the Purchasers shall each pay the fees and expenses of their respective advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party in connection with the negotiation, preparation, execution, delivery and performance of this Agreement.
6.2 Entire Agreement. The Transaction Documents, together with the exhibits and schedules thereto, contain the entire understanding of the parties with respect to the subject matter thereof and supersede all prior agreements, understandings, discussions warranties and representations, oral or written, with respect to such matters. Each of the parties acknowledges and agrees that it has not entered into this Agreement in reliance on any statement or representation of any person (whether a party to this Agreement or no) other than as expressly incorporated in this Agreement and the other Transaction Documents. Without limiting the generality of the foregoing, each of the parties irrevocably and unconditionally waives any right or remedy it may have to claim damages and/or to rescind this Agreement by reason of any misrepresentation (other than a fraudulent misrepresentation) having been made to it by any person (whether a party to this Agreement or not) and upon which it has relied in entering into this Agreement. Each of the parties acknowledges and agrees that the only cause of action available to it under the terms of this Agreement and the Transaction Documents in respect of a Claim shall be for breach of contract.
6.3 Further Assurance. At or after the Closing, and without further consideration, the Company and the Purchasers will execute and deliver to the other (and shall negotiate, if required, in good faith) such further documents as may be reasonably requested in order to give practical effect to the intention of the parties under the Transaction Documents.
6.4 Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and effective on the earliest of (a) the date of transmission, if such notice or communication is delivered via facsimile (provided the sender receives a machine-generated confirmation of successful transmission) or e-mail delivery of a .PDF format data file at the facsimile number or e-mail address, as applicable, specified in this Section 6.3 during the recipients normal business hours on a Business Day, (b) the next Business Day after the date of transmission, if such notice or communication is delivered via facsimile (provided the sender receives a machine-generated confirmation of successful transmission) or e-mail delivery of a .PDF format data file at the facsimile number or e-mail address, as applicable, specified in this Section 6.3 on a day that is not a Business Day or not during the recipients normal business hours on any Business Day, (c) the Business Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service with next day delivery specified, or (d) two Business Days after deposit with an internationally recognized expedited delivery services company, freight prepaid for delivery to a non-U.S. address, specifying next available Business Day delivery, with written verification of receipt. The address for such notices and communications shall be as follows:
If to the Company: | F-Star Therapeutics Limited | |||
Eddeva B920 Babraham Research | ||||
Campus | ||||
Cambridge, United Kingdom CB22 AT | ||||
Telephone No.: | +44-1223-497400 | |||
E-Mail: | John.Fitzpatrick@f-star.com | |||
Attention: | General Counsel | |||
With a copy to: | Mintz, Levin, Cohn, Ferris, Glovsky | |||
and Popeo, P.C. | ||||
One Financial Center | ||||
Boston, MA 02111 | ||||
Telephone No.: | (617) 542-6000 | |||
Facsimile No.: | (617) 542-2241 | |||
E-Mail: | wchicks@mintz.com | |||
Attn: | William Hicks | |||
If to a Purchaser: |
To the address set forth under such
Purchasers name on its signature page hereof |
or such other address as may be designated in writing hereafter, in the same manner, by such Person.
6.5 Amendments; Waivers; No Additional Consideration. No provision of this Agreement may be waived or amended except in a written instrument signed by the Company and the Purchasers hereto. No waiver of any default with respect to any provision, condition or requirement of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of any party to exercise any right hereunder in any manner impair the exercise of any such right. No consideration shall be offered or paid to any Purchaser to amend or consent to a waiver or modification of any provision of any Transaction Document unless the same consideration is also offered to all Purchasers who then hold Shares.
6.6 Construction. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof, or affect construction. The language used in this Agreement will be deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against any party.
6.7 Successors and Assigns. The provisions of this Agreement shall inure to the benefit of and be binding upon the parties and their successors and permitted assigns. This Agreement, or any rights or obligations hereunder, may not be assigned by the Company without the prior written consent of the Purchasers (other than by Exchange or consolidation or to an entity which acquires the Company, including by way of acquiring all or substantially all of the Companys assets). Any Purchaser may assign its rights hereunder in whole or in part to any Person to whom such Purchaser assigns or transfers any Shares in compliance with the Transaction Documents and applicable Legal Requirements, provided such transferee shall agree in writing to be bound, with respect to the transferred Shares, by the terms and conditions of this Agreement that apply to the Purchasers.
6.8 Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and, except as provided in the immediately preceding Section 6.7, is not for the benefit of, nor may any provision hereof be enforced by, any other Person.
6.9 Governing Law and Jurisdiction. This Agreement (and any dispute or claim relating to it or its subject matter (including non-contractual claims)) is governed by and is to be construed in accordance with English law. The parties irrevocably agree that the courts of England and Wales shall have exclusive jurisdiction to settle any claim, dispute or issue (including non-contractual claims) which may arise out of or in connection with this Agreement.
6.10 Survival. The warranties, including the Company Warranties, contained herein shall terminate at the Closing and only the agreements and covenants contained herein that by their terms survive the Closing shall survive the Closing in accordance with their terms.
6.11 Execution. This Agreement may be executed in two or more counterparts, each of which shall constitute an original, and all the counterparts when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party, it being understood that the parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission, or by e-mail delivery of a .PDF format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or .PDF signature page were an original thereof.
6.12 Severability. If any provision of this Agreement is held to be invalid or unenforceable by any judicial or other competent authority, the validity and enforceability of the remaining terms and provisions of this Agreement shall not in any way be affected or impaired thereby and the parties will attempt to agree upon a valid and enforceable provision that is a reasonable substitute therefor and achieves that same or substantially the same effect or result, and upon so agreeing, shall incorporate such substitute provision in this Agreement.
6.13 Replacement of Shares. If any Share Certificate evidencing any of the Shares is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof, or in lieu of and substitution therefor, a new Share Certificate, but only upon receipt of evidence reasonably satisfactory to the Company of such loss, theft or destruction and the execution by the holder thereof of a customary lost Share Certificate indemnity. The applicants for a new Share Certificate under such circumstances shall also pay any reasonable third-party costs associated with the issuance of such replacement Share Certificate. If a replacement Share Certificate evidencing any of the Shares is requested due to a mutilation thereof, the Company may require delivery of such mutilated Share Certificate as a condition precedent to any issuance of a replacement.
6.14 Remedies. Subject always to Section 6.2, in addition to being entitled to exercise all rights provided herein or granted by law, including recovery of damages, each of the Purchasers and the Company will be entitled to specific performance under the Transaction Documents. The parties agree that irreparable damage may occur in the event that any of the provisions of the Transaction Documents were not performed in accordance with their specific terms or were otherwise breached and that monetary damages may not be adequate compensation for any loss incurred by the Purchasers, the Company by reason of any breach of any such provisions.
6.15 Adjustments in Share Numbers and Prices. In the event of any share split, subdivision, dividend or distribution payable in Ordinary Shares (or other securities or rights convertible into, or entitling the holder thereof to receive directly or indirectly Ordinary Shares), combination, recapitalization, merger, consolidation or other reorganization or similar event occurring after the date hereof, each reference in any Transaction Document to the Shares, a number of Ordinary, a price per Ordinary Share or the class or type of securities with respect to the Shares shall be deemed to be amended to appropriately account for such event.
6.16 Independent Nature of the Purchasers Obligations and Rights. The obligations of each Purchaser under any Transaction Document are several and not joint with the obligations of any other Purchaser, and no Purchaser shall be responsible in any way for the performance of the obligations of any other Purchaser under any Transaction Document. The decision of each Purchaser to purchase Ordinary Shares pursuant to the Transaction Documents has been made by such Purchaser independently of any other Purchaser and independently of any information, materials, statements or opinions as to the business, affairs, operations, assets, properties, liabilities, results of operations, condition (financial or otherwise) or prospects of the Company which may have been made or given by any other Purchaser or by any agent or employee of any other Purchaser, and no Purchaser and any of its agents or employees shall have any liability to any other Purchaser (or any other Person) relating to or arising from any such information, materials, statement or opinions. Nothing contained herein or in any other Transaction Document, and no action taken by any Purchaser pursuant hereto or thereto, shall be deemed to constitute the Purchasers as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Purchasers are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction Documents. Each Purchaser acknowledges that no other Purchaser has acted as agent for such Purchaser in connection with making its investment hereunder and that no Purchaser will be acting as agent of such Purchaser in connection with monitoring its investment in the Shares or enforcing its rights under the Transaction Documents. Each Purchaser shall be entitled to independently protect and enforce its rights, including without limitation the rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for any other Purchaser to be joined as an additional party in any Proceeding for such purpose. The Company acknowledges that each of the Purchasers has been provided with the same Transaction Documents for the purpose of closing a transaction with multiple Purchasers and not because it was required or requested to do so by any Purchaser. The Companys obligations to each Purchaser under this Agreement and the other Transaction Documents are identical to its obligations to each other Purchaser other than such differences resulting solely from the number of Ordinary Shares purchased by such Purchaser.
6.17 Termination. This Agreement may be terminated and the sale and purchase of the Shares abandoned (a) with respect to a particular Purchaser, at any time prior to the Closing, by mutual written consent of the Company and such Purchaser; (b) if the Closing has not been consummated on or prior to 5:00 p.m., New York City time, on the End Date by any Purchaser (with respect to itself only), upon written notice to the Company; (c) if the Exchange has not been consummated on or prior to 5:00 p.m., New York City time, on the End Date by any Purchaser (with respect
to itself only), or (d) by either the Company or any Purchaser (with respect to such Purchaser only) upon written notice to the other if consummation of the transactions contemplated hereby would violate any no appealable order, degree or judgment of any Governmental Authority having competent jurisdiction; provided, however, that the right to terminate this Agreement under this Section 6.17 shall not be available to any Person whose failure to comply with its obligations under this Agreement has been the cause of or resulted in the failure of the Closing to occur on or before such time. Nothing in this Section 6.17 shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this Agreement or the other Transaction Documents or to impair the right of any party to compel specific performance by any other party of its obligations under this Agreement or the other Transaction Documents. In the event of a termination pursuant to this Section 6.17, the Company shall promptly notify all non-terminating Purchasers. Upon a termination in accordance with this Section 6.17, the Company and the terminating Purchaser(s) shall not have any further obligation or liability (including arising from such termination) to the other, and no Purchaser will have any liability to any other Purchaser under the Transaction Documents as a result therefrom.
6.18 Waiver of Conflicts. Each Purchaser acknowledges that: (a) it has read this Agreement; (b) it has been represented in the preparation, negotiation and execution of this Agreement by legal counsel of its own choice or has voluntarily declined to seek such counsel; and (c) it understands the terms and consequences of this Agreement and is fully aware of the legal and binding effect of this Agreement. Each Purchaser understands that the Company has been represented in the preparation, negotiation and execution of this Agreement by Company Counsel and that Company Counsel now or may in the future represent one or more Purchasers or their Affiliates in matters unrelated to the transactions contemplated by this Agreement, including the representation of such Purchasers or their Affiliates in matters of a nature similar to those contemplated by this Agreement. The Company and each Purchaser hereby acknowledge that they have had an opportunity to ask for and have obtained information relevant to such representation, including disclosure of the reasonably foreseeable adverse consequences of such representation, and hereby waives any conflict arising out of such representation solely with respect to the matters contemplated by this Agreement.
6.19 Public Announcement. The Company shall and shall require that Spring Bank, by 9:00 a.m., New York City time, on the first (1st) Business Day immediately following the date of this Agreement, issue one or more press releases or, in the case of Spring Bank, file with the Commission a current report on Form 8-K (collectively, the Disclosure Document) disclosing all material terms of the transactions contemplated hereby, the Exchange, and any other material, non-public information that the Company or Spring Bank has provided to Purchaser at any time prior to the filing of the Disclosure Document. From and after the issuance of the Disclosure Document, to the Companys Knowledge, the Purchasers shall not be in possession of any material, non-public information received from the Company or any of its officers, directors, or employees.
[Signature Pages Follow]
IN WITNESS WHEREOF, the parties hereto have caused this Subscription Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
F-STAR THERAPEUTICS LIMITED | ||
By: |
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Name: | Eliot Forster, Ph.D | |
Title: | President and Chief Executive Officer |
[Signature Page to Subscription Agreement]
PURCHASERS
[Subscription Agreement Signature Page]
ANNEX A
SCHEDULE OF PURCHASERS
Investment Syndicate |
Actual Subscription
Amount |
Calculated Shares |
Shares
Purchased Rounded Down to Whole Shares |
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Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the use in this Amendment No. 1 to the Registration Statement (No. 333-248487) on Form S-4 of Spring Bank Pharmaceuticals, Inc. of our report dated February 14, 2020, relating to the consolidated financial statements of Spring Bank Pharmaceuticals, Inc. and its subsidiaries, appearing in the Prospectus, which is part of this Registration Statement.
We also consent to the reference to our firm under the heading Experts in such Prospectus.
/s/ RSM US LLP
Boston, Massachusetts
September 30, 2020
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the use in this amendment No. 1 to the Registration Statement on Form S-4 of Spring Bank Pharmaceuticals, Inc. of our report dated August 28, 2020 relating to the financial statements of F-star Therapeutics Limited, which appears in this Registration Statement. We also consent to the reference to us under the heading Experts in such Registration Statement.
/s/ PricewaterhouseCoopers LLP
September 30, 2020
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the use in this amendment No. 1 to the Registration Statement on Form S-4 of Spring Bank Pharmaceuticals, Inc. of our report dated August 28, 2020 relating to the financial statements of F-star Biotechnologische Forschungs-und Entwicklungsges.m.b.H, which appears in this Registration Statement. We also consent to the reference to us under the heading Experts in such Registration Statement.
/s/ PricewaterhouseCoopers LLP
September 30, 2020
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the use in this amendment No. 1 to the Registration Statement on Form S-4 of Spring Bank Pharmaceuticals, Inc. of our report dated August 28, 2020 relating to the financial statements of F-star Beta Limited, which appears in this Registration Statement. We also consent to the reference to us under the heading Experts in such Registration Statement.
/s/ PricewaterhouseCoopers LLP
September 30, 2020
Exhibit 99.1
PRELIMINARY PROXY CARD
VOTE BY INTERNET | ||
Before The Meeting - Go to www.proxyvote.com | ||
SPRING BANK PHARMACEUTICALS, INC. 35 PARKWOOD DRIVE, SUITE 210 HOPKINTON, MA 01748 |
Use the Internet to transmit your voting instructions and for electronic delivery of information up until 11:59 p.m. Eastern Time the day before the cut-off date or meeting date. Have your proxy card in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form. | |
During The Meeting - Go to www.virtualshareholdermeeting.com/SBPH2020SM | ||
You may attend the meeting via the Internet and vote during the meeting. Have the information that is printed in the box marked by the arrow available and follow the instructions. | ||
VOTE BY PHONE - 1-800-690-6903 | ||
Use any touch-tone telephone to transmit your voting instructions up until 11:59 p.m. Eastern Time the day before the cut-off date or meeting date. Have your proxy card in hand when you call and then follow the instructions. | ||
VOTE BY MAIL | ||
Mark, sign and date your proxy card and return it in the postage-paid envelope we have provided or return it to Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717. |
TO VOTE, MARK BLOCKS BELOW IN BLUE OR BLACK INK AS FOLLOWS:
D23277-S09232 KEEP THIS PORTION FOR YOUR RECORDS |
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DETACH AND RETURN THIS PORTION ONLY
THIS PROXY CARD IS VALID ONLY WHEN SIGNED AND DATED.
SPRING BANK PHARMACEUTICALS, INC. | ||||||||||||||||||
The Board of Directors recommends a vote FOR Proposals 1, 2, 3 and 4. |
For | Against | Abstain | |||||||||||||||
1. |
Proposal to approve the issuance of Spring Bank common stock to holders of F-star Therapeutics Limited (F-star) share capital, including holders who purchase F-star securities prior to the closing of the Exchange (defined below), in accordance with the Share Exchange Agreement, dated as of July 29, 2020, by and among Spring Bank, F-star and the holders of issued and outstanding capital shares and convertible loan notes of F-star (the Exchange), in an amount representing more than 20% of the shares of Spring Bank common stock outstanding immediately prior to the Exchange, which shall also constitute stockholder approval of a change of control of Spring Bank, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively. | ! | ! | ! | ||||||||||||||
2. |
Proposal to approve an amendment of Spring Banks certificate of incorporation to effect a reverse split of all outstanding shares of the Spring Bank common stock at a reverse stock split ratio as mutually agreed to by Spring Bank and F-star in the range of one new share for every [TBD] to [TBD] shares outstanding (or any number in between). | ! | ! | ! | ||||||||||||||
3. |
Proposal to approve an amendment to the amended and restated certificate of incorporation of Spring Bank to change the corporate name of Spring Bank from Spring Bank Pharmaceuticals, Inc. to F-star Therapeutics, Inc. effective upon the closing of the Exchange. | ! | ! | ! | ||||||||||||||
4. |
Proposal to approve a postponement or adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 or 3. | ! | ! | ! | ||||||||||||||
NOTE: Such other business as may properly come before the meeting or any adjournment thereof. |
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Please indicate if you plan to attend this virtual meeting. ! |
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Please sign exactly as name(s) appear(s) hereon. Joint owners should each sign. When signing as attorney, executor, administrator, corporate officer, trustee, guardian, or custodian, please give full title. |
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Signature [PLEASE SIGN WITHIN BOX] | Date | Signature (Joint Owners) | Date |
Important Notice Regarding the Availability of Proxy Materials for the Special Meeting:
The Proxy Statement is available at www.proxyvote.com.
D23278-S09232 |
SPRING BANK PHARMACEUTICALS, INC.
35 Parkwood Drive, Suite 210 |
Hopkinton, MA 01748 |
(508) 473-5993 |
PROXY FOR SPECIAL MEETING OF STOCKHOLDERS |
[TBD], 2020 |
THE BOARD OF DIRECTORS OF SPRING BANK PHARMACEUTICALS, INC. SOLICITS THIS PROXY |
The undersigned, revoking any previous proxies relating to these shares, hereby appoints Martin Driscoll and Lori Firmani, and each of them (with full power to act alone), the attorneys and proxies of the undersigned, with power of substitution to each, to vote all shares of the common stock of Spring Bank Pharmaceuticals, Inc. (Spring Bank) registered in the name provided in this Proxy which the undersigned is entitled to vote at the Special Meeting of Stockholders, to be held at [TBD], Eastern Time on [TBD], 2020 via live audio webcast at www.virtualshareholdermeeting.com/SBPH2020SM (the Special Meeting), and at any adjournments of the meeting, with all the powers the undersigned would have if personally present at the meeting. Without limiting the general authorization given by this Proxy, the proxies are, and each of them is, instructed to vote or act as follows on the proposals set forth in the Proxy. |
This Proxy, when executed, will be voted in the manner directed herein. If you do not specify on the reverse side how you want your shares to be voted, this Proxy will be voted FOR Proposals 1, 2, 3 and 4. |
In their discretion, the Proxies are authorized to vote upon such other business as may properly come before the meeting. |
Continued and to be signed on reverse side
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