As filed with the Securities and Exchange Commission on October 26, 2021.
Registration No. 333-260301
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1 to
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
IO Biotech, Inc.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or organization) |
2834
(Primary Standard Industrial Classification Code Number) |
87-0909276
(I.R.S. Employer Identification Number) |
Mai-Britt Zocca
Ole Maaløes Vej 3
DK-2200 Copenhagen N
Denmark
Tel: +45 7070 2980
(Address, including zip code, and telephone number, including area code, of Registrants principal executive offices)
Corporation Trust Company
Corporation Trust Center
1209 Orange Street
Wilmington, DE 19801
Tel: (800) 677-3394
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Frank F. Rahmani Istvan A. Hajdu Sidley Austin LLP 555 California Street, Suite 2000 San Francisco, CA 94104 (650) 565-7000 |
Nathan Ajiashvili
Alison Haggerty
1271 Avenue of the Americas
New York, NY 10020
|
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, 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, please 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(c) 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, a smaller reporting company, or an emerging growth 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.
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 7(a)(2)(B) of the Securities Act. ☐
CALCULATION OF REGISTRATION FEE
|
||||
Title of Each Class of
Securities to be Registered |
Proposed Maximum
Aggregate Offering Price(1)(2) |
Amount of
Registration Fee(3) |
||
Common Stock, par value $0.001 per share |
$100,000,000 | $9,270 | ||
|
||||
|
(1) |
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended. |
(2) |
Includes the aggregate offering price of any additional common stock that the underwriters have the option to purchase, if any. |
(3) |
Previously paid in connection with the prior filing of the registration statement. |
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 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
EXPLANATORY NOTE
This amendment is being filed solely to file certain exhibits to the Registration Statement as indicated in Item 16 of Part II. No changes are being made to the preliminary prospectus constituting Part I of the Registration Statement or Items 13, 14, 15 or 17 of Part II of the Registration Statement, and the preliminary prospectus has therefore not been included herein.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The following table sets forth all expenses to be paid by the registrant, other than estimated underwriting discounts and commissions, in connection with this offering. All amounts shown are estimates except for the Securities and Exchange Commission registration fee, the Financial Industry Regulatory Authority (FINRA) filing fee and the exchange listing fee:
Amount
to be Paid |
||||||
Securities and Exchange Commission registration fee |
$ | 9,270 | ||||
FINRA filing fee |
15,500 | |||||
Nasdaq Global Market listing fee |
* | |||||
Printing and engraving expenses |
* | |||||
Legal fees and expenses |
* | |||||
Accounting fees and expenses |
* | |||||
Transfer agent and registrar fees |
* | |||||
Miscellaneous |
* | |||||
|
|
|||||
Total |
$ | * | ||||
|
|
* |
To be filed by amendment. |
Item 14. Indemnification of Directors and Officers
IO Biotech, Inc. is incorporated under the laws of the State of Delaware. Reference is made to Section 102(b)(7) of the DGCL, which enables a corporation in its original certificate of incorporation or an amendment thereto to eliminate or limit the personal liability of a director for violations of the directors fiduciary duty, except (1) for any breach of the directors duty of loyalty to the corporation or its stockholders, (2) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (3) pursuant to Section 174 of the DGCL, which provides for liability of directors for unlawful payments of dividends or unlawful stock purchase or redemptions or (4) for any transaction from which the director derived an improper personal benefit.
Section 145(a) of the DGCL provides, in general, that a corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation), because he or she is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding, if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.
Section 145(b) of the DGCL provides, in general, that a corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor because the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys fees) actually and reasonably incurred by the person in connection with the defense or settlement of such action or suit if he or she acted in good faith and in a manner he or she reasonably believed to
II-1
be in or not opposed to the best interests of the corporation, except that no indemnification shall be made with respect to any claim, issue or matter as to which he or she shall have been adjudged to be liable to the corporation unless and only to the extent that the adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, he or she is fairly and reasonably entitled to indemnity for such expenses which the adjudicating court shall deem proper.
Section 145(g) of the DGCL provides, in general, that a corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of his or her status as such, whether or not the corporation would have the power to indemnify the person against such liability under Section 145 of the DGCL.
We expect that the amended and restated certificate of incorporation adopted by us prior to the completion of this offering will provide that no director of our company shall be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duty as a director, except for liability (1) for any breach of the directors duty of loyalty to us or our stockholders, (2) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (3) in respect of unlawful dividend payments or stock redemptions or repurchases or other distributions pursuant to Section 174 of the DGCL, or (4) for any transaction from which the director derived an improper personal benefit. In addition, our charter will provide that if the DGCL is amended to authorize the further elimination or limitation of the liability of directors, then the liability of a director of our company shall be eliminated or limited to the fullest extent permitted by the DGCL, as so amended.
We also expect our charter will further provide that any amendment, repeal or modification of such article unless otherwise required by law will not adversely affect any right or protection existing at the time of such repeal or modification with respect to any acts or omissions occurring before such repeal or amendment of a director serving at the time of such repeal or modification.
We expect that our amended and restated certificate of incorporation adopted by us prior to the completion of this offering, will provide that we shall indemnify each of our directors and executive officers, and shall have power to indemnify our other officers, employees and agents, to the fullest extent permitted by the DGCL as the same may be amended (except that in the case of an amendment, only to the extent that the amendment permits us to provide broader indemnification rights than the DGCL permitted us to provide prior to such the amendment) against any and all expenses, judgments, penalties, fines and amounts reasonably paid in settlement that are incurred by the director, officer or such employee or on the directors, officers or employees behalf in connection with any threatened, pending or completed proceeding or any claim, issue or matter therein, to which he or she is or is threatened to be made a party because he or she is or was serving as a director, officer or employee of our company, or at our request as a director, partner, trustee, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of our company and, with respect to any criminal proceeding, had no reasonable cause to believe his or her conduct was unlawful. We expect the amended and restated certificate of incorporation will further provide for the advancement of expenses to each of our directors and, in the discretion of the board of directors, to certain officers and employees, in advance of the final disposition of such action, suit or proceeding only upon receipt of an undertaking by such person to repay all amounts advanced if it shall ultimately be determined by final judicial decision from which there is no further right to appeal that such person is not entitled to be indemnified for such expenses.
In addition, we expect the amended and restated certificate of incorporation will provide that the right of each of our directors and officers to indemnification and advancement of expenses shall not be exclusive of any
II-2
other right now possessed or hereafter acquired under any statute, provision of the charter or bylaws, agreement, vote of stockholders or otherwise. Furthermore, our amended and restated certificate of incorporation will authorize us to provide insurance for our directors, officers, employees and agents against any liability, whether or not we would have the power to indemnify such person against such liability under the DGCL or the bylaws.
We have entered into indemnification agreements with each of our directors and our executive officers. These agreements will provide that we will indemnify each of our directors and such officers to the fullest extent permitted by law and our amended and restated certificate of incorporation.
We also maintain a general liability insurance policy which covers certain liabilities of directors and officers of our company arising out of claims based on acts or omissions in their capacities as directors or officers.
In any underwriting agreement we will enter into in connection with the sale of the common stock being registered hereby, the underwriters will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control us within the meaning of the Securities Act, against certain liabilities.
Item 15. Recent Sales of Unregistered Securities
In the three years preceding the filing of this registration statement, the registrant has sold and issued the following unregistered securities:
(1) |
In May 2018, IO Biotech ApS issued convertible notes to three accredited investors for proceeds of approximately $9.6 million. |
(2) |
In December 2018, IO Biotech ApS issued and sold an aggregate of 139,744 class B preference shares to three accredited investors at a subscription price of $67.03 per share upon the conversion of convertible notes and interest accrued thereon. |
(3) |
In July 2019, IO Biotech ApS issued convertible notes to three accredited investors for proceeds of $9.0 million. |
(4) |
In April 2020, IO Biotech ApS issued and sold an aggregate of 142,437 class B preference shares to three accredited investors at a subscription price of $64.48 per share upon the conversion of convertible notes. |
(5) |
In July 2020, IO Biotech ApS issued and sold an aggregate of 75,845 class B preference shares to three accredited investors at a purchase price of $67.46 per share for aggregate proceeds of approximately $5.1 million. |
(6) |
In January 2021, IO Biotech ApS issued and sold an aggregate of 505,520 class C preference shares to 17 accredited investors at a purchase price of $121.55 per share for aggregate proceeds of approximately $61.5 million. |
(7) |
In March 2021, IO Biotech ApS issued and sold an aggregate of 35,825 class C preference shares to five accredited investors at a purchase price of $121.55 per share for aggregate proceeds of approximately $4.2 million. As a result of entering into a collaboration agreement with Merck in September 2021, the number of class C preference shares issued in March 2021 was adjusted downward to 32,568 class C preference shares. |
(8) |
In July 2021, IO Biotech ApS granted to its directors, officers, employees, consultants and other service providers warrants to purchase 196,198 class A ordinary shares, at an exercise price of $68.10 per share, which was subsequently adjusted to $44.84 per share. |
(9) |
In October 2021, IO Biotech ApS granted to its directors, officers, employees, consultants and other service providers warrants to purchase 454,623 class A ordinary shares, at an exercise price of $44.84 per share. |
The offers, sales and issuances of the securities described in paragraphs (1) through (7) above were exempt from registration under the Securities Act under Section 4(a)(2) of the Securities Act as transactions by an issuer not involving a public offering. The recipients of securities in each of these transactions acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate
II-3
legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions was an accredited person and had adequate access, through employment, business or other relationships, to information about IO Biotech ApS.
The offers, sales and issuances of the securities described in paragraph (8) and (9) above were exempt from registration under the Securities Act under either (1) Rule 701 in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided under Rule 701 or (2) Section 4(a)(2) of the Securities Act as transactions by an issuer not involving a public offering. The recipients of securities in each of these transactions acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions was a service provider of IO Biotech ApS and received the securities under contracts relating to compensation.
Item 16. Exhibits and Financial Statement Schedules
(a) Exhibits
See the Exhibit Index immediately preceding the signature page hereto for a list of exhibits filed as part of this registration statement on Form S-1, which Exhibit Index is incorporated herein by reference.
(b) Financial Statement Schedules
Schedules not listed have been omitted because the information required to be set forth therein is not applicable, not material or is shown in the financial statements or notes thereto.
Item 17. Undertakings
The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, (the Act), may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
The undersigned registrant hereby undertakes that:
(1) |
For purposes of determining any liability under the Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective. |
(2) |
For the purpose of determining any liability under the Act, each post-effective amendment that contains a form of prospectus 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. |
II-4
EXHIBIT INDEX
Exhibit
|
Description |
|
1.1* |
Form of Underwriting Agreement |
|
3.1* |
Amended and Restated Certificate of Incorporation of IO Biotech, Inc., as amended, to be in effect on the completion of the offering |
|
3.2* |
Form of Amended and Restated Bylaws of IO Biotech, Inc., to be in effect on the completion of the offering |
|
4.1* |
Form of Common Stock Certificate |
|
5.1* |
Opinion of Sidley Austin LLP |
|
10.1+* |
Form of Indemnification Agreement |
|
10.2+* |
Form of IO Biotech, Inc. 2021 Equity and Incentive Plan and related form agreements, to be in effect on the completion of the offering |
|
10.3+* |
Form of IO Biotech, Inc. 2021 Employee Stock purchase Plan and related form agreements, to be in effect on the completion of the offering |
|
10.4 | ||
10.5 | ||
10.6 | ||
10.7 | ||
10.8 | ||
10.9 | ||
10.10 | ||
10.11 | ||
10.12 | ||
10.13* |
Investors Rights Agreement, dated October , 2021, by and among IO Biotech, Inc. and the Investors and Key Holders party thereto |
|
10.14+ |
Service Agreement, dated August 21, 2017, by and between IO Biotech ApS and Mai-Britt Zocca |
|
10.15+ | ||
10.16+ |
Service Agreement, dated August 21, 2017, by and between IO Biotech ApS and Eva Ehrnrooth |
|
10.17+ |
Addendum to Service Agreement, dated April 1, 2021, by and between IO Biotech ApS and Eva Ehrnrooth |
II-5
Exhibit
|
Description |
|
21.1 | ||
23.1* |
Consent of Sidley Austin LLP (included in Exhibit 5.1) |
|
23.2# |
Consent of EY Godkendt Revisionspartnerselskab, independent registered public accounting firm |
|
24.1# |
Power of Attorney (included on the signature page to this Registration Statement) |
* |
To be filed by amendment. |
+ |
Indicates management contract or compensatory plan. |
# |
Previously filed. |
|
Portions of the exhibit have been excluded because it both (i) is not material and (ii) would be competitively harmful if publicly disclosed. |
II-6
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Copenhagen, Denmark, on the 26th day of October 2021.
IO Biotech, Inc. |
||
By: |
/s/ Mai-Britt Zocca, Ph.D. |
|
Mai-Britt Zocca, Ph.D. |
||
Chief Executive Officer |
Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated:
Signature |
Title |
Date |
||
/s/ Mai-Britt Zocca, Ph.D. Mai-Britt Zocca, Ph.D. |
Chief Executive Officer; Director (Principal Executive Officer) | October 26, 2021 | ||
/s/ Keith Vendola, M.D., M.B.A. Keith Vendola, M.D., M.B.A. |
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
October 26, 2021 | ||
* Peter Hirth, Ph.D. |
Chairman of the Board | October 26, 2021 | ||
* Kathleen Sereda Glaub |
Director | October 26, 2021 | ||
* Emmanuelle Coutanceau, Ph.D. |
Director | October 26, 2021 | ||
* Christian Elling, Ph.D. |
Director | October 26, 2021 | ||
* Claus Andersson, Ph.D. |
Director | October 26, 2021 | ||
* Priyanka Belawat, Ph.D. |
Director |
October 26, 2021 | ||
* Jack B. Nielsen |
Director | October 26, 2021 | ||
* Vanessa Malier |
Director | October 26, 2021 |
*By | /s/ Mai-Britt Zocca, Ph.D. | |
Mai-Britt Zocca, Ph.D. | ||
Attorney-in-Fact |
II-7
Exhibit 10.4
*Portions of this exhibit have been excluded because it both (i) is not material and (ii) would be competitively harmful if publicly disclosed.
OPTION ASSIGNMENT AGREEMENT
between
IO Biotech ApS
and
Herlev Hospital
Option Assignment Agreement
THIS OPTION ASSIGNMENT AGREEMENT (this Agreement) shall come into force and be effective as of the Effective Date as defined below, cf. Clause 1, and is entered into by and between
(1) |
IO Biotech ApS |
[***]
(hereafter Company)
and
(2) |
Herlev Hospital (Region Hovedstaden) |
[***]
(hereafter Hospital)
WHEREAS [***] and [***] (the Inventors) under their employment at Hospital have made an invention titled INDOLEAMINE 2, 3-DIOXYGENASE BASED IMMUNOTHERAPY (the Invention),
WHEREAS Hospital has acquired ownership to the Invention pursuant to the Danish Act on Inventions at Public Research Institutions,
WHEREAS Hospital has filed a Danish priority patent application covering said Invention, and filed a PCT patent application claiming priority from said application and subsequently entered national phase continuing said PCT patent application (see Exhibit 1 for list of patent applications),
WHEREAS the inventors together with business partners have set up Company with the purpose to commercialize said patent rights,
WHEREAS Company intend to seek investors to provide financing for commercialization of said patent rights,
WHEREAS Hospital desires to assign said patent rights to Company when Company has secured financing for commercialization of said patent rights,
WHEREAS Hospital grants Company an option to purchase said patent rights on the terms and conditions set out in this Agreement,
NOW THEREFORE, Hospital and Company have entered into this Agreement on the following terms:
1. |
DEFINITIONS |
In this Agreement, the following words shall have the following meanings:
Affiliate(s) shall mean any legal entity directly or indirectly controlling, controlled by, or under common control with the Company, for as long as such control lasts. For the purpose of this definition control means direct or indirect control of the entity through:
Page 2 of 9
Option Assignment Agreement
(i) |
control or ownership of more than 50 (fifty) % of the nominal value of the equity capital of the entity, or |
(ii) |
control or ownership of more than 50 (fifty) % of the voting rights of the equity capital of the entity, or |
(iii) |
a right by any other means to elect or appoint directors of the entity, or persons performing similar functions, who have a majority vote. |
Clinical Data the specification of studies and data, and accordingly the exact definition of Clinical Data, shall be finalized in Exhibit II before 1 June 2015.
Effective Date shall be the date of the last signature to this Agreement.
Exercise Date shall mean the date where Company has duly exercised the Option.
Exercise Period shall mean [***].
License shall mean a non-exclusive license (the License) to access the Clinical Data, as set out in Clause 2.1, for the purpose of further research, development, exploitation and commercialization of the Patent Rights.
Option shall have the meaning ascribed thereto in Clause 2.
Parties shall mean the Company and Hospital collectively.
Party shall mean the Company or Hospital respectively.
Patent Rights shall mean the patent applications set out in Exhibit 1, including any divisions, revisions, extensions, continuations, continuations-in-part, derived from the patent applications in Exhibit las well as any patents which may issue therefrom and any reissues.
Third Party or Third Parties shall mean any person or entity other than Hospital and Company, with the exception of Affiliates.
The singular shall where the context permits it include the plural, and vice-versa.
2. |
GRANT OF OPTION |
2.1 |
Hospital hereby grants the Company on the terms in this Agreement an exclusive Option to purchase the Patent Rights and the grant of License. For the avoidance of doubt, the purchase of the Patent Rights shall include unrestricted access for the Company to any know-how relating to the Patent Rights generated prior to the Effective Date. |
The License shall be non-exclusive, worldwide, perpetual and fully paid-up. The License shall include unrestricted access and use rights for the Company to any Clinical Data generated by Hospital. Prior to the Effective Date, Hospital has provided the Company with full and accurate copy of all Clinical Data generated prior to the Effective Date. Hospital shall, at Companys written request, and upon payment of the actual costs related to providing the Clinical Data, provide Company with Clinical Data generated after the Effective Date.
Page 3 of 9
Option Assignment Agreement
2.2 |
Company may exercise this Option at any time in the Exercise Period, provided Company has secured equity as further set out in this Clause 2.2 in the amount of at least [***]. Company shall exercise this Option by providing written notification to Hospital that it exercises the Option and by providing written documentation that the Company has full and unrestricted equity in the amount of at least [***] at the time it exercises the Option and that it has incurred no substantial liabilities or other obligations that materially erodes the value of said equity at said time. |
2.3 |
If Company has not duly exercised the Option in the Exercise Period the Option has lapsed and this Agreement shall no longer be in effect. In the event hereof Hospital retains all rights to the Patent Rights free of any commitments to Company and may exercise said rights as it sees fit. |
3. |
ASSIGNMENT AND REASSIGNMENT |
3.1 |
Upon exercise of the Option, Hospital assigns the full ownership rights to the Patent Rights and grant the License to Company on the terms and conditions in this Agreement and Company accepts the assignment on the terms and conditions in this Agreement. |
3.2 |
The consideration to be paid by Company to Hospital for the assignment of the Patent Rights is set out in Clause 4. |
3.3 |
Hospital shall sign any documents regarding the registration of the assignment of the Patent Rights by patent authorities and other similar documents necessary to effectuate the assignment by said patent authorities. All said documents shall be in accordance with the terms and conditions in this Agreement. All direct costs in association herewith shall be borne by Company. |
3.4 |
If the total investments, including convertible and/or sub-ordinated loans, made by Company shareholders in the Company by [***] (the Deadline) do not comprise [***] (the Threshold), the Hospital may require reassignment by the Company of all IP initially assigned to the Company under the Agreement (the Re-Assignment Option). If the Company at any time prior to [***] documents to the Hospital that investments made reach the Threshold, the Re-Assignment Option shall be deemed void ex nunc. If the Threshold is not reached by the Deadline, the Hospital may invoke the Re-Assignment Option. If the Re-Assignment Option has not been invoked by the Hospital by [***], the Re-Assignment Option shall be deemed void. Re-assignment costs to third parties (patent agents, patent authorities, etc.) shall be borne by the Hospital. No consideration shall be payable by the Hospital to the Company for the reassignment. If the IP is re-assigned, the License lapses on the effective date of Reassignment. |
Page 4 of 9
Option Assignment Agreement
If this Agreement is not terminated in accordance with Clause 9 and if Company has no secured equity in at least the amount set out in this Clause 3.4 at the above date, Company shall reassign to Hospital without any consideration any and all Patent Rights pending or in force at said date free and clear of any and all liens, mortgages and encumbrances. If Company prior to [***] knows that it will not be able to comply with the equity requirement in this Clause 3.4 it shall loyally try to protect Hospitals rights to have the Patent Rights pending or in force at such time reassigned and it shall use reasonable efforts to maintain Patent Rights pending or in force at such time.
4. |
PAYMENT |
4.1 |
The Patent Rights shall be sold by the Hospital to the Company and the License shall be granted to the Company in exchange for a purchase sum comprising both the following two elements: |
i) |
Payment of 2,0 (two) MDKK. [***], |
and
ii) |
[***]% royalty on net sales (to be defined as per industry standards) [***]. |
[***].
4.2 |
Company may at any time buy-out the Hospitals rights as per this Agreement by paying to the Hospital a purchase sum to be agreed upon, and in any case [***] Such payment shall be in full and final settlement of any claim that Hospital may otherwise have under this Agreement (including, without limitation, Hospitals rights under Clause 3.4). |
5. |
PATENT PROSECUTION AND ENFORCEMENT |
5.1 |
Until the Exercise Date Hospital shall manage the Patent Rights in accordance with this Agreement. Hospital shall maintain and prosecute the Patent Rights, that is Hospital may not abandon any Patent Rights without consulting Company and Hospital shall use its reasonably best efforts to prosecute the Patent Rights in consultation with Company. If patent authorities rejects the issuance of patents from the patent applications under the Patent Rights, Hospitals obligation hereunder shall be limited to filing replies, objections or continuations to the respective national patent offices, and Hospital shall not be required to participate in oral proceedings at patent offices nor to file any lawsuits or to engage in any defense of the Patent Rights by either the courts or patent offices, if the Patent Rights validity or issuance is challenged by Third Parties. |
5.2 |
Upon the Exercise Date Hospitals obligation to manage the Patent Rights shall automatically terminate and Company shall have the full right to manage the Patent Rights, including, but not limited to file, maintain, prosecute, defend and enforce any patent applications or patents under the Patent Rights. Company shall be free to make any decisions regarding the Patent Rights, however, Company shall comply with the obligations in Clause 3.4 in the event Clause 3.4 becomes applicable. Further, upon the Exercise Date, Hospital shall provide the Company with prompt and complete access to any files and documents in the possession of Hospital and Hospitals external patent advisors. Company shall pay any direct costs related to the above mentioned access invoiced by external patent advisors. |
Page 5 of 9
Option Assignment Agreement
5.3 |
Hospital shall have no obligation whatsoever to enforce the Patent Rights or to take any legal actions against any actual or alleged infringement of the Patent Rights. |
6. |
REPRESENTATIONS AND WARRANTIES |
6.1 |
Hospital represents and warrants: |
i) |
that Hospital is the sole owner of the Patent Rights, free and clear of any and all liens, mortgages and encumbrances; |
ii) |
that the Patent Rights is maintained and under prosecution in accordance with Clause 5.1; |
iii) |
that no license or option rights regarding the Patent Rights are or have been granted to Third Parties. |
6.2 |
Hospital gives no other representations and warranties than explicitly stated under Clause 6.1 above with respect to the Patent Rights and nothing in this Agreement shall be construed explicitly or implied: |
i) |
as a representation or warranty by Hospital that the Patent Rights will proceed to grant; |
ii) |
as a representation or warranty by Hospital that practicing the invention(s) disclosed in the Patent Rights will not infringe the patents or other proprietary rights of Third Parties and that Company will not need to obtain or license any other rights, including intellectual property rights from one or more Third Parties; |
iii) |
as a representation or warranty by Hospital that at the Exercise Date there are no administrative or judicial proceedings contesting the inventorship, ownership, validity, or enforceability of any element of Patent Rights or that any such event cannot happen hereafter; however Hospital has not, to the best of its knowledge as of the Effective Date, any information about any such proceedings or threatened proceedings; |
iv) |
as a representation or warranty by Hospital that the Patent Rights will lead to the development of any product; or |
v) |
as a representation or warranty by Hospital as to the patentability, validity, scope, merchantability or usefulness of the Patent Rights. |
7. |
LIABILITY AND DISCLAIMER |
7.1 |
Either Party shall in accordance with Danish law be liable for damages, losses, costs or expenses sustained by the other Party as a result of, arising from or in connection with breach of this Agreement. [***]. |
7.2 |
[***]. |
Page 6 of 9
Option Assignment Agreement
8. |
INDEMNIFICATION |
8.1 |
[***]. |
9. |
TERM AND TERMINATION |
9.1 |
This Agreement shall be effective on the Effective Date and shall terminate without notice if Company does not duly exercise the Option in accordance with Clause 2, and if Company duly exercises the Option when Hospital has received the complete and full payment according with Clause 4 or upon reassignment of the Patent Rights in accordance with Clause 3.4. |
9.2 |
In the event of material breach of this Agreement occurred before the Exercise Date the Party not in material breach may terminate this Agreement with written notice with immediate effect, if the Party in material breach has failed to remedy the breach within [***] after a receiving written notice requiring such remedy to be made. |
9.3 |
Upon expiry or termination of this Agreement Clause 10, 11, 12 of this Agreement shall survive and continue to be in force, subject to any subsequent dates of termination if any referred to in these individual Clauses. In addition hereto shall any provisions that by their nature and intent would be expected to be in force survive termination of this Agreement. |
10. |
CONFIDENTIALITY AND PUBLICATION |
10.1 |
The existence of this Agreement is not confidential, but the commercial terms of this Agreement is confidential. However i) Company is entitled to disclose the entire Agreement to potential investors or industrial partners as well as to advisors and ii) Hospital is entitled to disclose the entire Agreement to advisors and to publish the general terms of the Agreement, but without publishing details of the intended investment scope under this Agreement. |
11. |
MISCELLANEOUS |
11.1 |
Neither this Agreement nor any interest hereunder may be assigned in part or in whole by a Party without the prior written consent of the other Party. Notwithstanding the foregoing, the Company may sub-license, assign and/or transfer its rights in full or in part under this Agreement provided that the Company remains liable for the payment obligations set out in clause 4 in this Agreement. |
11.2 |
The waiver by Company or Hospital of any breach by one of the others of any of the provisions of this Agreement shall not be deemed to be a waiver of any subsequent or continuing breach of this Agreement. |
Page 7 of 9
Option Assignment Agreement
11.3 |
If there is any conflict between any provision of this Agreement and any applicable law, the latter shall prevail, but in such event the affected provisions of this Agreement shall be curtailed and limited only to the extent necessary to bring it within applicable law. Consequently, if any provision of this Agreement is ultimately held to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions hereof shall not in any way be affected or impaired thereby. The Parties shall negotiate in good faith to replace such provision with one that will be valid, legal and enforceable but differs substantively from the replaced provision as little as possible. |
11.4 |
All notices and consents required or permitted to be given under this Agreement must be in writing and shall be send to the address of Company or Hospital set out in this Agreement, or to such other address as either one may designate to the other by written notice. |
11.5 |
This Agreement may not be changed, modified, amended or supplemented except by a written instrument signed by both Parties. |
11.6 |
Neither Party to this Agreement shall commit any act or take any action frustrating or hampering the rights of the other Party under this Agreement. Each Party shall act in good faith and engage in fair dealing when taking any action under or related to this Agreement. |
12. |
GOVERNING LAW AND VENUE |
12.1 |
This Agreement shall be governed by. construed and enforced in accordance with the laws of Denmark, excluding, however, Danish choice of law rules to the extent that such rules would otherwise lead to the application of any other law than Danish law. |
12.2 |
The parties submit to the exclusive jurisdiction of the city court of Copenhagen in the first instance to resolve any dispute between them. |
AGREED TO AND SIGNED BY DULY AUTHORIZED REPRESENTATIVE OF
Herlev Hospital
Name: Steen Werner Hansen
Title: Vice Director, Herlev Hospital
Date: 1/2/2015
Place: Herlev
/s/ Steen Werner Hansen |
(Signature) |
IO Biotech ApS
Name: Mai-Britt-Zocca
Title: CEO
Date: 1/2/2015
Place: København
/s/ Mai-Britt Zocca |
Page 8 of 9
Option Assignment Agreement
/s/ Mai Britt-Zocca |
(Signature) |
IO Biotech ApS
Name: Nanna Lüneborg
Title: Director of the Board
Date: 1/2/2015
Place: Charlottenlund
/s/ Nanna Lüneborg |
(Signature) |
Page 9 of 9
Exhibit 10.5
ADDENDUM I TO
OPTION ASSIGNMENT AGREEMENT
between
IO Biotech ApS
and
Herlev Hospital
Addendum to Option Assignment Agreement
THIS ADDENDUM (hereinafter referred to as the Addendum) is entered into on the date last mentioned below by and between
IO Biotech ApS
[***]
(hereinafter referred to as the Company)
and
Herlev Hospital (Region Hovedstaden)
[***]
(hereinafter referred to as the Hospital)
(hereinafter collectively referred to as the Parties and individually as a Party)
RECITALS
(A) |
WHEREAS the Parties have entered into an Option Assignment Agreement of 2 January 2015 (hereinafter referred to as the Agreement) regarding the grant by the Hospital to the Company of an option to acquire certain intellectual property rights as further defined in the Agreement (hereinafter referred to as the Option) and of a license to access certain data defined as Clinical Data in the Agreement (hereinafter referred to as the License); |
(B) |
WHEREAS the definition of the data to which the Company is granted access under the License indicates a limitation of such data to not include any other type of data than clinical data; |
(C) |
WHEREAS the data actually accessed and used by the Company pursuant to the Parties cooperation under the Agreement, including the License, encompasses other types of data than such data which would ordinarily be understood to be clinical data; |
(D) |
WHEREAS the Hospital acknowledges the fact that the Company has been granted a de facto access to other types of data pursuant to the Parties cooperation and that the Companys access to other types of data than so-called clinical data will be beneficial to the Parties cooperation under the Agreement and therefore in the best interests of both Parties; and |
- Page 2 of 4 -
Addendum to Option Assignment Agreement
(E) |
WHEREAS the Parties wish to acknowledge in writing that their common understanding of the types of data to which the Company is granted access pursuant to the Agreement, including the License, include all types of data generated in connection with the clinical trials performed pursuant to the Parties cooperation under the Agreement and not only data which would ordinarily not be understood to be so-called clinical data; |
NOW THEREFORE, the Parties have entered into this Addendum to the Agreement on the following terms and conditions:
1. |
DEFINITION OF CLINICAL DATA |
1.1. |
Notwithstanding anything to the contrary in the Agreement or its exhibits, the Parties hereby agree and acknowledge that the definition of Clinical Data as set out in the Agreement with exhibits shall not be understood to only include data which would ordinarily be understood to be so-called clinical data, but should also be understood to include any type of data which may have been or which may be 1) generated in connection with or 2) leading up to and used in the following clinical trials: |
1.1.1. |
First in man study of an IDO targeting checkpoint vaccine (IDO peptide in Montanide adjuvant) (NCT01219348) |
1.1.2. |
First in man clinical trial testing an IDO vaccine in combination with ipilimumab (NCT 02077114) |
2. |
NO CONSIDERATION |
2.1. |
Neither Party shall be obligated to pay any kind of consideration for the acknowledgements and agreements made pursuant to this Addendum. |
3. |
RIGHTS AND OBLIGATIONS UNDER THE AGREEMENT |
3.1. |
The Parties agree and acknowledge that this Addendum only sets out the Parties common understanding of the types of data which is included in the definition of Clinical Data in the Agreement. The Parties therefore further agree that this Addendum shall not in any way confer any rights or impose any obligations on either Party except as specifically set out in this Addendum and that this Addendum shall not in any way add to or subtract from the rights and/or obligations set out in or related to the Agreement, including the License, or the Parties cooperation pursuant thereto. |
3.2. |
The Parties acknowledge and agree that the provisions of the Agreement with exhibits not expressly altered by this Addendum shall continue to apply in respect of the Parties cooperation pursuant to the Agreement. |
- Page 3 of 4 -
Addendum to Option Assignment Agreement
4. |
GOVERNING LAW AND VENUE |
4.1. |
This Addendum shall be governed by, construed and enforced in accordance with the laws of Denmark, excluding, however, Danish choice of law rules to the extent that such rules would otherwise lead to the application of any other law than Danish law. |
4.2. |
The Parties submit to the exclusive jurisdiction of the city court of Copenhagen in the first instance to resolve any dispute between them in respect of this Addendum. |
---000---
AGREED TO AND SIGNED BY DULY AUTHORIZED REPRESENTATIVES OF
Herlev Hospital |
Name: Steen Werner Hansen |
Title: Vice Director, Herlev Hospital |
Date: 2/5/16 |
Place: Herlev |
/s/ Steen Werner Hansen |
IO Biotech ApS |
Name: Mai-Britt Zocca Title: CEO |
Date: 5/4/16 |
Place: Copenhagen |
/s/ Mai-Britt Zocca |
- Page 4 of 4 -
Exhibit 10.6
*Portions of this exhibit have been excluded because it both (i) is not material and (ii)
would be competitively harmful if publicly disclosed.
FRAMEWORK
ASSIGNMENT AGREEMENT
BETWEEN
HERLEV HOSPITAL
AND
IO BIOTECH ApS
On ______________ 2016, the following parties
Herlev Hospital
[***]
(hereinafter referred to as Hospital)
and
IO Biotech ApS
[***]
(hereinafter referred to as the Company)
have entered into a framework assignment agreement regarding the potential assignment from the Hospital to the Company of intellectual property rights and title in and to certain inventions which may be made by the Hospital or any of its employees on the terms and conditions set out in this framework assignment agreement.
RECITALS
(A) |
WHEREAS the Hospital is a hospital owned and operated by the Capital Region of Denmark (in Danish: Hovedstadsregionen) performing research and providing medical treatment of patients within various medical fields; |
(B) |
WHEREAS the Hospital inter alia employs researchers, scientists, doctors and other personnel within the medical field who, during and related to their employment at the Hospital, may make inventions within their field of expertise; |
(C) |
WHEREAS the Hospital is entitled, but not obligated, to acquire ownership of such inventions pursuant to the Danish Act on Inventions at Public Research Institutions; |
(D) |
WHEREAS the Company is a limited liability company incorporated under Danish law performing research and experimental development within the field of therapies aiming at activating or boosting T cells that react towards regulatory immune cells for the treatment and prevention of cancer, and/or related activities as per board discretion; |
(E) |
WHEREAS the Parties have already entered into an option assignment agreement dated 2 January 2015 regarding the grant by the Hospital to the Company of an option to acquire certain intellectual property rights in and to an invention referred to as Indoleamine 2, 3-dioxygenase based immunotherapy which option the Company subsequently has exercised; |
(F) |
WHEREAS the Company has expressed the desire to acquire similar inventions in order to perform research and development within the field of therapies aiming at activating or boosting T cells that react towards regulatory immune cells for the treatment and prevention of cancer; |
(G) |
WHEREAS such acquisition will be to the benefit of both the development of the invention already assigned to the Company, of the research to be performed within the medical field to which the inventions pertain and of the development of future inventions covered by this framework agreement; and |
1
(H) |
WHEREAS the Parties wish to enter into a framework assignment agreement regarding the potential assignment by the Hospital to the Company of certain intellectual property rights to certain inventions made after the effective date of this framework agreement within the field of the business of the Company; |
NOW THEREFORE, the Parties have entered into this framework assignment agreement (hereinafter referred to as the Framework Agreement) on the following terms and conditions:
1. |
DEFINITIONS |
1.1. |
In this Framework Agreement, the following terms and expressions shall have the following meanings: |
1.1.1. |
Affiliate shall, in respect of the Hospital, mean any hospital owned and operated by the Capital Region or the Capital Region itself and, in respect of the Company, mean any other legal entity that directly or indirectly, through one or more intermediaries, Controls, is directly or indirectly Controlled by, or is directly or indirectly under common Control with the Company, including for this purpose each person that serves as a director or officer of the Company; |
1.1.2. |
Assignment shall mean the assignment by the Hospital to the Company of any Invention and any related Intellectual Property Rights, and any rights and title to such Invention and Intellectual Property Rights, pursuant to any Specific Assignment Agreement entered into pursuant to this Framework Agreement; |
1.1.3. |
Capital Region shall mean the Capital Region of Denmark (in Danish: Region Hovedstaden), [***]; |
1.1.4. |
Company shall mean IO Biotech ApS, [***]; |
1.1.5. |
Confidential Information shall mean all information regarding a Party, an Invention and/or any Intellectual Property Right thereto which i) the Party to which the information pertains has specifically designated as confidential, which ii) pertains to a general type of information which the Party to which the information pertains has specifically designated as confidential or which iii) without any such specific designation as confidential by the Party to which the information pertains would otherwise reasonably be deemed as confidential; |
1.1.6. |
Control (including Controlling) shall mean direct or indirect control of the entity in question through: |
1.1.6.1. |
direct or indirect control or ownership of more than 50 (fifty) % of the nominal value of the share capital of the entity, |
2
1.1.6.2. |
direct or indirect control or ownership of more than 50 (fifty) % of the voting rights attached to the share capital of the entity, or |
1.1.6.3. |
a right or cumulative rights by any other means to elect or appoint directors of the entity, or persons performing similar functions, who have a majority vote; |
1.1.7. |
Exhibit shall mean any appendix to this Framework Agreement or to a Separate Assignment Agreement; |
1.1.8. |
Exercise Period shall mean a period of 3 months starting from the Companys receipt of the Notice; |
1.1.9. |
Exit shall mean (i) an initial public offering (IPO) of all or part of the Companys shares, or of the shares of a company Controlling the Company; (ii) transfer of Control of the Company, or of Control of a company Controlling the Company, to any person or legal entity (including transfer of a non-controlling interest whereby any person or legal entity obtains Control of the Company or of a company Controlling the Company); (iii) a sale of all or a material part of the Intellectual Property Rights which have been assigned or otherwise transferred to the Company pursuant to a Specific Assignment Agreement, including any licensing thereof to a person or legal entity; (iv) a sale of all or a material part of the Companys other assets, including any transfer or licensing of all or a material part of the Companys other intellectual property rights to a person or legal entity, if such transaction implies that the Company ceases to operate as an active company with substantial on-going research and/or business activities; (v) liquidation of the Company, (vi) a merger or de-merger in which the Company or a company Controlling the Company is the discontinuing entity, or (vii) any combination of the above, which can reasonably be considered equal to an Exit, including two or more of the events mentioned above which, considered alone, cannot reasonably be considered as an Exit but which, considered together, can reasonably be considered as a coherent series of events constituting an Exit; |
1.1.10. |
Field shall mean therapies aiming at activating or boosting T cells that react towards regulatory immune cells for the treatment and prevention of cancer; |
1.1.11. |
Framework Agreement shall mean this framework assignment agreement with Exhibits, if any; |
1.1.12. |
Intellectual Property Right shall mean any intellectual property right pertaining to any patents, utility models and applications for patents and utility models which may have been filed by the Hospital or any of its Affiliates in respect of an Invention covered by this Framework Agreement and/or any Specific Assignment Agreement and/or the right to file such patent and utility model applications; |
1.1.13. |
Invention shall mean any invention made within the Field by one or more Inventors during such Inventors employment with the Hospital to which the Hospital has taken over all the Intellectual Property Rights in accordance with the Danish Act on Inventions at Public Research Institutions; for the avoidance of doubt, notwithstanding anything to the contrary in this Agreement, any invention made pursuant to a cooperation, whether formalized through written contract or not, with a third party shall not be encompassed by this definition; |
3
1.1.14. |
Inventor shall mean any of the following persons who are employed with the Hospital at the time of the execution of this Framework Agreement: [***] and [***]; |
1.1.15. |
Notice shall mean a written notice forwarded by the Hospital to the Company which sets out i) that the Hospital has taken over one or more specific Inventions from the Inventors, ii) a description of the specific Inventions and iii) that the Company shall inform the Hospital of its decision within the Exercise Period whether or not to enter into negotiations with the Hospital regarding the Companys potential acquisition of the Intellectual Property Rights to the Invention; |
1.1.16. |
Option shall mean the Companys option to decide, within the Exercise Period, whether or not the Hospital shall enter into negotiations with the Company in respect of the Companys potential acquisition of Intellectual Property Rights to a specific Invention, such potential acquisition by the Company being conditioned upon the Parties entering into a Specific Assignment Agreement in respect of such specific Invention; |
1.1.17. |
Party shall mean either the Hospital or the Company; |
1.1.18. |
Revenue shall mean any payments generated by the Company based on an Invention and/or the assignment of Intellectual Property Rights to the Company pursuant to a Specific Assignment Agreement, including but not limited to license fees (or sublicense fees, if applicable), down payments, milestone or exit payments, royalties and/or other fees and any other payments generated from the development and/or commercialization of the Invention or the assignment or other type of transfer to a third party of any Intellectual Property Right; |
1.1.19. |
Separate Invention shall mean an invention made by one or more of the Inventors which is not within the Field; and |
1.1.20. |
Specific Assignment Agreement shall mean such specific assignment agreement with Exhibits, if any, entered into pursuant to this Framework Agreement by which the Hospital assigns an Invention and Intellectual Property Rights to the Company. |
1.2. |
The singular shall, where the context does not exclude it, include the plural and vice-versa. |
1.3. |
The definitions set out above shall also apply to any Specific Assignment Agreement entered into pursuant to this Framework Agreement without any further, specific incorporation thereof. |
2. |
AGREEMENT STRUCTURE |
2.1. |
The overall rights and obligations of the Parties in respect of any Assignment are set out in this Framework Agreement. Further and more specific provisions regulating the specific assignment of any Invention and Intellectual Property Rights and the consideration to be paid in that regard shall be set out in one or more Specific Assignment Agreements to be negotiated in good faith and entered into by the Parties pursuant to this Framework Agreement. |
4
2.2. |
Specific Assignment Agreements shall not come into force and be legally binding on the Parties before they have been duly executed by authorized representatives of both Parties. |
2.3. |
In the event of discrepancies or inconsistencies between the provisions of this Framework Agreement and provisions of one or more Specific Assignment Agreements, the provisions of this Framework Agreement shall prevail. |
3. |
MAKING OF INVENTIONS |
3.1. |
The Company understands and acknowledges that when an invention is made by an employee of the Hospital, including Inventions made by the Inventors within the Field, the inventors thereof are obligated to inform the Hospital of the making of the invention. The Company further understands and acknowledges that, pursuant to the Danish Act on Inventions at Public Research Institutions, the Hospital is entitled to, in its own discretion, either take over the intellectual property rights and title in and to such invention or to let such intellectual property rights and title remain with the inventors, in which case such intellectual property rights shall not be encompassed by this Framework Agreement. The Hospitals decision whether or not to take over such intellectual property rights and title is based on an assessment of the commercial potential of the invention in question. |
3.2. |
In the event that the Hospital decides to not take over such rights to an Invention, all intellectual property rights and title in and to the specific invention will vest with the inventors. |
4. |
GRANT AND EXERCISE OF OPTION |
4.1. |
The Hospital hereby grants the Company the Option on the terms and conditions set out herein. |
4.2. |
In the event that the Hospital decides to take over the Intellectual Property Rights to an Invention, the Hospital shall inform the Company thereof in writing by issuing a Notice. The Company shall then be entitled to exercise the Option in respect of the specific Invention in question within the relevant Exercise Period. |
4.3. |
In the event that the Company exercises the Option within the Exercise Period, the Parties shall enter into negotiations in good faith regarding the terms and conditions of the Companys potential acquisition of the Invention In question and the Intellectual Property Rights to such Invention. |
4.4. |
In the event that the Parties agree on the terms and conditions of the Companys acquisition of the Invention in question and the Intellectual Property Rights to such Invention, such terms and conditions shall be set out in a Specific Assignment Agreement which shall come into force upon the Parties due execution thereof. |
5
4.5. |
In the event that the Parties have not executed a Specific Assignment Agreement in respect of the Intellectual Property Rights to the Invention in question no later than 6 months after the Company has exercised the Option, the Hospital shall not be obligated to continue the negotiations with the Company. |
5. |
CONSIDERATION |
5.1. |
Each Specific Assignment Agreement shall set out the consideration to be paid by the Company for the transfer of Intellectual Property Rights pursuant to such Specific Assignment Agreement. |
5.2. |
Any assignment of Inventions and Intellectual Property Rights by the Hospital pursuant to a Specific Assignment Agreement shall be subject to the payment of the applicable consideration set out in the Specific Assignment Agreement. Material nonpayment of the applicable consideration shall be construed as a material breach of the Specific Assignment Agreement and, in the event of such non-payment, the Invention and the Intellectual Property Rights for which the Company did not pay the applicable consideration shall automatically be re-assigned to the Hospital without payment of consideration by the Hospital to the Company. All other terms of payment of the applicable consideration under a Specific Assignment Agreement shall set out in such Specific Assignment Agreement. |
6. |
DEVELOPMENT OF INVENTIONS |
6.1. |
The Parties agree that the Company shall employ its commercially reasonable efforts to develop and commercialize any Invention to which Intellectual Property Rights have been assigned to the Company pursuant to a Specific Assignment Agreement which shall set out further details on the Companys obligation to develop and commercialize such Invention. |
6.2. |
[***], the Company shall provide the Hospital with an overview of the Companys current plans for and the progress of the development and commercialization of such Inventions. Furthermore, the Company shall keep the Hospital apprised of the progress of pending negotiations with a third party, if any, which could reasonably result in an Exit, however only to the reasonable extent that the Company is not bound by confidentiality obligations towards such third party in respect of the negotiations in question. |
7. |
INTELLECTUAL PROPERTY RIGHTS |
7.1. |
All Intellectual Property Rights and title in and to the Inventions covered by this Framework Agreement and/or any Specific Assignment Agreement shall vest in the Hospital at the time upon which the Hospital takes over the Intellectual Property Rights to such Inventions from the Inventors. |
7.2. |
Pursuant to the provisions of this Framework Agreement, the Parties may agree in a Specific Assignment Agreement that the Company shall acquire a specific Invention and Intellectual Property Rights to such specific Invention by way of an Assignment. In lack of such a Specific Assignment Agreement, all Intellectual Property Rights to all the Inventions shall vest with the Hospital. |
7.3. |
The Specific Assignment Agreement in question shall set out the Invention and the type and scope of the Intellectual Property Rights which shall be assigned or otherwise transferred to the Company pursuant to the Specific Assignment Agreement. |
6
8. |
SEPARATE INVENTIONS |
8.1. |
In the event that one or more of the Inventors develop an invention which classify as a Separate Invention, such Separate Invention shall not be deemed to be encompassed by this Framework Agreement or any Specific Assignment Agreement which the Parties may have entered into at the time of the making of the invention in question unless the Parties agree otherwise in writing. |
9. |
PATENT PROSECUTION AND ENFORCEMENT |
9.1. |
The Company agrees and acknowledges that it shall use all commercially reasonable efforts to obtain the best possible protection of the Intellectual Property Rights assigned to it pursuant to any Specific Assignment Agreement, including by filing, prosecuting and maintaining all relevant patent applications, in those countries and territories where the Company reasonably deems it commercially relevant for the Company to obtain protection of such Intellectual Property Rights. |
9.2. |
In the event that it comes to the Companys attention that a third party has clearly infringed or is clearly infringing any Intellectual Property Right assigned to the Company pursuant to a specific Assignment Agreement, the Company shall be obligated to inform the Hospital about the infringement and shall take all commercially reasonable measures to stop the infringement, provided that the Company reasonably deems such measures to be commercially necessary for the protection of the Intellectual Property Rights assigned to the Company. |
9.3. |
The Company does not have the right to reach a settlement with an infringing or potentially infringing third party without the consent of the Hospital if such settlement could have a material adverse effect on the potential Revenue. |
10. |
CONFIDENTIALITY |
10.1. |
The Parties may not in any way disclose Confidential Information to any third party, excluding legal counsel and similar advisors who are bound by standard confidentiality obligations for such advisors, and shall use the same standards of care in keeping the Confidential Information confidential as they would use in respect of their own confidential information. Notwithstanding the foregoing, in no event shall the Parties be entitled to use a lower standard or care than a reasonable person would to protect its own confidential information. |
10.2. |
Notwithstanding anything in the foregoing to the contrary, the confidentiality obligations set out in section 10.1 shall not apply to Confidential Information which (1) was known by the receiving Party prior to receiving the Confidential Information; (2) becomes rightfully known to the receiving Party from a third-party source not under an obligation to maintain confidentiality; (3) ls or becomes publicly available through no fault of or failure to act by the receiving Party in breach of this Agreement; or (4) is or has been independently developed by employees, consultants or agents of the receiving Party without violation of the terms of this Agreement or reference or access to any Confidential Information. |
7
10.3. |
To the extent that a Party discloses Confidential Information pursuant to binding resolutions or decisions made by competent legal authorities, pursuant to applicable laws and regulations requiring such disclosure of Confidential Information or to any patent authorities, courts or arbitration panels solely in order to prosecute, maintain or enforce Intellectual Property Rights, the Party disclosing such Confidential Information shall not be deemed to be in breach of its confidentiality obligations under this Agreement. Information disclosed pursuant to this section 10.3 shall, however, remain Confidential Information for the purposes of this Framework Agreement. |
10.4. |
In the event that a Party breaches its confidentiality obligations pursuant to this section 10, the Party shall be liable to pay damages (excluding punitive damages) to the other Party in accordance with Danish law. |
11. |
PUBLICATION |
11.1. |
Neither Party may publicize any information regarding any of the Inventions covered by a Specific Assignment Agreement without the other Partys prior written consent. |
11.2. |
Notwithstanding the above or anything to the contrary in this Framework Agreement, including section 11.3 below, and/or a Specific Assignment Agreement, either Party may publicize information about an Invention covered by a Specific Assignment Agreement when a patent application has been filed in respect of such Invention or upon the expiration and/or termination of the Specific Assignment Agreement in question. |
11.3. |
The above restrictions on publication shall not in any way limit any rights to publicize any information explicitly conferred by law upon employees of a Party which the Party is not legally entitled to restrict. The Parties agree, however, that no invention or any information relating to an invention shall be published [***], reference is made to section 3.1. Further, the Parties agree that they shall use best efforts to avoid publication of any information about an Invention covered by a Specific Assignment Agreement for as long as a patent application has not been filed in respect of such Invention to the extent that they are legally entitled to do so. |
12. |
REPRESENTATIONS AND WARRANTIES |
12.1. |
Any representations and warranties issued by the Parties in connection with the assignment of any Intellectual Property Rights under any Specific Assignment Agreement shall be set out in the relevant Specific Assignment Agreement in order for them to be binding upon the Parties. |
8
13. |
LIABILITY AND INDEMNIFICATION |
13.1. |
The Parties shall be liable for damages in accordance with Danish law. |
13.2. |
[***]. |
13.3. |
[***]. |
14. |
TERM AND TERMINATION |
14.1. |
This Framework Agreement shall come into force and be legally binding upon the Parties at the time of the execution hereof by duly authorized representatives of each Party. This Framework Agreement shall have no set expiration date but may be terminated by either Party in accordance with the provisions thereon set out in this Framework Agreement. |
14.2. |
A Specific Assignment Agreement shall come into force and be legally binding upon the Parties at the time of the execution thereof by duly authorized representatives of each Party and shall expire upon the expiration or termination thereof in accordance with the provisions thereon in such Specific Assignment Agreement. |
14.3. |
Either Party may terminate this Framework Agreement without cause with a six (6) months written notice to the other Party. |
14.4. |
In the event of a material breach of this Framework Agreement, the Framework Agreement may be terminated by the non-breaching Party by issuing a written notice to the breaching Party stating the non-breaching Partys wish to terminate the Framework Agreement, and the grounds for such wish. Unless the breach is of such a nature that it may not be remedied, the non-breaching Party shall have [***] from the receipt of the notice to remedy the breach. In the event that the breach is not remedied within such period of time or if the breach is of such a nature that it may not be remedied, this Framework Agreement shall automatically terminate. |
14.5. |
Each Specific Assignment Agreement shall set out the termination provisions applicable to such Specific Assignment Agreement, including provisions regulating the consequences of termination. Termination of this Framework Agreement for whatever reason shall not affect the binding effect of any Specific Assignment Agreement executed prior to the effective date of termination of this Framework Agreement. |
15. |
MISCELLANEOUS |
15.1. |
This Framework Agreement constitutes the entire understanding between the Parties and supersedes any and all prior or contemporaneous understandings and agreements, whether oral or written, between the Parties with respect to the subject matter hereof. This Framework Agreement can only be modified by a written amendment signed by both Parties. |
15.2. |
Neither Party shall be entitled to transfer any of its rights and/ or obligations under this Framework Agreement or any Specific Assignment Agreement. For the avoidance of doubt, the Company shall be entitled to transfer Intellectual Property Rights to a third party by granting a license to use such Intellectual Property Rights without the other Partys prior written consent. |
9
15.3. |
In the event that a provision of this Framework Agreement or a Specific Assignment Agreement is found by a court of competent jurisdiction to be unenforceable, such provision shall be modified, rewritten or interpreted to include as much of its nature and scope as will render it enforceable. If it cannot be so modified, rewritten or interpreted to be enforceable in any respect, it shall not be given effect, and the remainder of this Framework Agreement or the relevant Specific Assignment Agreement shall be enforced as if such provision was not included. |
15.4. |
Any failure by either Party to enforce the other Partys strict performance of any provision of this Framework Agreement or a Specific Assignment Agreement shall not constitute a waiver of the former Partys right to subsequently enforce such provision or any other provision of this Framework Agreement or the Specific Assignment Agreement. |
15.5. |
Any notices required or permitted to be given under this Agreement shall be given in writing by electronic mail (email). Such notices shall be deemed delivered on the date upon which the email was sent. Notices shall be sent to the following addresses or to such other addresses as may be designated by the receiving Party: |
If to the Hospital:
Herlev Hospital
[***]
with an electronic copy to
[***]
If to IO Biotech ApS:
IO Biotech ApS
[***]
16. |
GOVERNING LAW AND VENUE |
16.1. |
This Framework Agreement and all Specific Assignment Agreements entered into pursuant to this Framework Agreement shall be governed by and construed in accordance with the laws of Denmark, excluding, however, choice of law provisions to the extent that such provisions would otherwise lead to the application of any other law than Danish law. |
16.2. |
In the event of a dispute between the Parties related to this Framework Agreement or any Specific Assignment Agreement entered into pursuant to this framework Agreement, hereunder but not limited to the existence, validity, interpretation, and performance of any provision of this Framework Agreement or a Specific Assignment Agreement, the Parties shall seek to settle the dispute by negotiations in good faith. Such negotiations shall be commenced by a Party submitting a written request to the other Party requesting such negotiations to commence. |
10
16.3. |
In the event that such negotiations do not lead to a settlement of the dispute within 4 weeks from the commencement thereof, and only then, either Party shall be entitled to submit the dispute to the city court of Copenhagen in the first instance to resolve any dispute between them. Any decision or verdict rendered by such court shall be subject to appeal in accordance with applicable law. |
---000---
(signature page follows)
11
SIGNATURES |
For and on behalf of Herlev Hospital |
Date: 5/2/2016 |
/s/ Steen Werner Hansen |
Name: Steen Werner Hansen Title: Deputy Chief Executive |
For and on behalf of IO Biotech ApS
Date: 4/5/2016
|
/s/ Mai-Britt Zocca |
Name: Mai-Britt Zocca Title: CEO |
12
Exhibit 10.7
*Portions of this exhibit have been excluded because it both (i) is not material and (ii)
would be competitively harmful if publicly disclosed.
ASSIGNMENT AGREEMENT
BETWEEN
HERLEV AND GENTOFTE HOSPITAL
AND
IO BIOTECH ApS
On ______________ 2016, the following parties
Herlev and Gentofte Hospital
[***]
(hereinafter referred to as Hospital)
and
IO Biotech ApS
[***]
(hereinafter referred to as the Company)
(hereinafter collectively referred to as the Parties and individually as a Party)
have entered into this assignment agreement regarding the assignment by the Hospital to the Company of certain intellectual property rights on the terms and conditions set out in the following.
RECITALS
(A) |
WHEREAS the Hospital is a hospital owned and operated by the Capital Region of Denmark (in Danish: Hovedstadsregionen) performing research and providing medical treatment of patients within various medical fields; |
(B) |
WHEREAS the Hospital inter alia employs researchers, scientists, doctors and other personnel within the medical field who, during and related to their employment at the Hospital, may make inventions within their field of expertise; |
(C) |
WHEREAS [***] has made certain inventions in respect of PD-L1 based immunotherapy; |
(D) |
WHEREAS the Hospital has acquired and taken over the intellectual property rights and title in and to said inventions pursuant to the Danish Act on Inventions at Public Research Institutions; |
(E) |
WHEREAS the Hospital thereafter holds all of the intellectual property rights and title in and to said inventions; |
(F) |
WHEREAS the Company is a limited liability company incorporated under Danish law performing research and experimental development within the field of biotechnology whose purpose is to develop a vaccine targeting immune inhibiting cells for the purpose of prevention and/or treatment of cancer, and/or to pursue related activities as per board discretion; |
(G) |
WHEREAS the Parties have already entered into an Option Assignment Agreement dated 2 January 2015 regarding the grant by the Hospital to the Company of an option to acquire certain intellectual property rights, including an invention referred to as Indoleamine 2,3-dioxygenase based immunotherapy which option the Company subsequently has exercised; |
1
(H) |
WHEREAS the Company, pursuant to the Companys exercise of such option, has expressed its desire to also acquire the inventions covered by this assignment agreement; |
(I) |
WHEREAS such acquisition will be to the benefit of the development of the inventions covered by this assignment agreement and of the research to be performed within the medical field to which such inventions pertain; and |
(J) |
WHEREAS the Company therefore desires to acquire from the Hospital and the Hospital desires to assign to the Company the Hospitals intellectual property rights and title in and to the inventions and the intellectual property rights covered by this assignment agreement on the terms and conditions set out in this assignment agreement; |
NOW THEREFORE, the Parties have entered into this assignment agreement on the following terms and conditions:
1. |
DEFINITIONS |
1.1. |
In this assignment agreement, the following expressions and words shall have the following meanings: |
1.1.1. |
Agreement shall mean this assignment agreement with Exhibits, if any. |
1.1.2. |
Affiliate shall mean any legal entity directly or indirectly Controlling, Controlled by, or under common Control with the entity in question, for as long as such Control lasts. |
1.1.3. |
Assignee shall mean a Third Party to whom the Company by any means transfers Intellectual Property Rights (however, not including by way of the grant of a license in Intellectual Property Rights). |
1.1.4. |
Capital Region shall mean the Capital Region of Denmark (in Danish: Region Hovedstaden), [***]. |
1.1.5. |
Clinical Data shall mean the data specifically generated in connection with or leading up to and used in the studies and research connected with the making or the development of one or more of the Inventions either prior to or after the Execution Date, which studies and research are set out in Exhibit 1. |
1.1.6. |
Confidential Information shall mean all information which i) a Party has specifically designated as confidential, which ii) pertains to a general type of information which a Party has specifically designated as confidential or which iii) would otherwise reasonably be deemed as confidential. |
1.1.7. |
Control (including Controlling and Controlled) shall mean direct or indirect control of the entity in question through: |
1.1.7.1. |
direct or indirect control or ownership of more than fifty (50) % of the nominal value of the equity capital of the entity, or |
2
1.1.7.2. |
direct or indirect control or ownership of more than fifty (50) % of the voting rights of the equity capital of the entity. |
1.1.8. |
Covenant shall mean any of the obligations of the Company towards the Hospital set out in Section 8.1. |
1.1.9. |
Execution Date shall mean the date of the last signature to this Agreement. |
1.1.10. |
Exhibit shall mean any exhibit to this Agreement. |
1.1.11. |
Exit shall mean one of the following events taking place after the Execution Date: (i) an initial public offering (IPO), whether directly or through holding or other ownership structures, of all or part of the Companys Shares, or of all or part of the shares of a company Controlling the Company; (ii) transfer of Control of the Company, or of Control of a company Controlling the Company, whether directly or through holding or other ownership structures, to any person or legal entity (including transfer of a noncontrolling interest whereby any person or legal entity obtains Control of the Company or of a company Controlling the Company); (iii) a transfer to a Third Party, whether by sale, the grant of a license or by any other means, of all or a material part of the Companys other assets if such transaction implies that the Company ceases to operate as an active company with substantial on-going research and/or business activities; (iv) solvent liquidation or winding up of the Company, (v) a merger or demerger in which the Company or a company Controlling the Company is the discontinuing entity, or (vi) any combination of the above, which can reasonably be considered equal to an Exit, including two or more of the events mentioned above which, considered alone, cannot reasonably be considered as an Exit but which, considered together, can reasonably be considered as a coherent series of events constituting an Exit. |
1.1.12. |
Final Payment shall mean the payment to be made at the discretion of the Company to the Hospital in accordance with Section 5.4. |
1.1.13. |
IDO shall mean the invention referred to as Indoleamine 2,3-dioxygenase based immunotherapy described in patent application [***] in respect of which the Parties entered into an option assignment agreement dated 2 January 2015. |
1.1.14. |
Intellectual Property Rights shall mean all of the Hospitals intellectual property rights and title in and to the Patent Applications and any patent issued or to be issued deriving priority from the Patent Applications, including any provisionals, nonprovisionals, divisions, revisions, extensions, continuations, continuations-in-part and substitutions derived from the Patent Applications or from any such patent issued or to be issued and any reissues of such patents and all intellectual property rights in any patent applications to be filed pursuant to this Agreement. |
1.1.15. |
Inventions shall mean the inventions referred to as PD-Ll based immunotherapy and PD-Ll Peptides for use in cancer vaccines, respectively, and described in the Patent Applications. |
1.1.16. |
Key Country shall mean any of the countries and territories listed in Exhibit 3. |
3
1.1.17. |
License shall mean a non-exclusive license to access and use Clinical Data in accordance with the terms and conditions set out in this Agreement. |
1.1.18. |
Licensee shall mean a Third Party to whom the Company grants a license to use and/or distribute in any way any of the Inventions and/or any Intellectual Property Right. |
1.1.19. |
Milestone Payment shall mean the payment of an amount of [***]. |
1.1.20. |
Patent Applications shall mean the patent applications set out in Exhibit 2. |
1.1.21. |
Product shall mean any product which is within the scope of the Intellectual Property Rights and any product which is developed on the basis of any one or a combination of the Inventions and/or any Intellectual Property Right and which is sold by the Company, any Licensee or any Assignee. |
1.1.22. |
Related Party shall have the meaning ascribed to the term nærstående in section 2 of the Danish Bankruptcy Act. |
1.1.23. |
Representations and Warranties shall mean the representations and warranties issued by the Hospital in accordance with Section 7.1. |
1.1.24. |
Revenues shall mean the aggregate amount of (i) any payment (excluding value added tax and any other applicable taxes and duties) paid to the Company and any of its Affiliates and Related Parties and (ii) the value of any non-monetary receipt obtained by the Company and any of its Affiliates and Related Parties, and derived from the use of or based on any one or both of the Inventions, including if used in combination with any other invention or pharmaceutical or any combination of one or both of the Inventions and TDO and/or IDO, or in relation to or based on any Intellectual Property Right. Revenues include without limitation license fees (or sublicense fees, if applicable), option fees, down payments, milestone payments, royalties, service fees and other fees and similar types of payments and any other payments generated from the development and/or commercialization of one or both of the Inventions (also if used in combination with TDO and/or IDO) and/or any Intellectual Property Right or from the assignment or other type of transfer to a Third Party of one or both of the Inventions and/or any Intellectual Property Right. For clarity, it is expressly understood that Revenues shall not include any Sales. |
1.1.25. |
Royalty Payment shall mean any payment to be made by the Company to the Hospital pursuant to Section 5.3. |
1.1.26. |
Sales shall mean the invoiced price of Products sold by and paid to the Company and any of its Affiliates and Related Parties in arms length transactions exclusively for money or, where the sale is not at arms length or not exclusively for money, the price that would have been so invoiced if it had been at arms length exclusively for money, after deduction of all documented: |
(a) |
normal trade discounts which are actually granted and any credits actually given for rejected or returned Products to the extent that such discounts and credits are reasonable and customary in the applicable market; |
4
(b) |
costs of packaging, insurance, carriage, and freight, provided in each case that the amounts are separately charged on the relevant invoice and only to the extent that such costs are reasonable and customary in the applicable market; |
(c) |
mandatory value added tax or other applicable and mandatory sales tax; and |
(d) |
mandatory import duties or similar applicable mandatory government levies. |
1.1.27. |
Section shall mean a provision of this Agreement (excluding the Exhibits) defined by a number. |
1.1.28. |
Shareholder shall mean any physical person and any legal entity holding Shares in the Company. |
1.1.29. |
Shares shall mean shares issued by the Company and other financial instruments (e.g. warrants, convertible loans and other instruments which comprise a right to acquire new or existing shares in the Company, which right may be conditional) issued by the Company. |
1.1.30. |
Sublicensee shall mean a Third Party to whom the Company grants a license to access, use and/or distribute in any way any of the Clinical Data. |
1.1.31. |
TDO shall mean the invention referred to as [***] described in patent application [***]. |
1.1.32. |
Third Party shall mean any person or entity other than the Parties. |
1.1.33. |
Valid Claim shall mean (a) in the case of an issued and unexpired patent under the Intellectual Property Rights, a claim that has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (b) in the case of a pending patent application, a pending claim that has not been cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or refiling of such application. |
1.2. |
The singular shall, where the context does not exclude it, include the plural and vice versa. |
2. |
ASSIGNMENT AND GRANT |
2.1. |
Subject to the terms and conditions set out in this Agreement and with effect as of the Execution Date, the Hospital i) assigns its full and complete title and ownership in and to all of the Intellectual Property Rights and the Patent Applications to the Company and ii) grants the License to the Company. |
2.2. |
The consideration to be paid by the Company to the Hospital for i) the assignment of the Intellectual Property Rights and the Patent Applications to the Company and ii) the grant of the License is set out in Section 5. |
5
3. |
THE INTELLECTUAL PROPERTY RIGHTS |
3.1. |
The Company shall only be entitled to transfer Intellectual Property Rights to an Assignee in the event that i) the Company has made the Milestone Payment, including accrued interests, cf. Section 5.2.1, and ii) the Assignee in question assumes the Companys obligations towards the Hospital pursuant to this Agreement to make Royalty Payments and to prosecute and enforce the Intellectual Property Rights. |
3.2. |
In the event that the Company transfers Intellectual Property Rights to an Assignee pursuant to the above and the Company and/or a Company Affiliate and/or a Related Party later acquires such Intellectual Property Rights from the same Assignee or another Third Party, the Company shall re-assume the payment obligations towards the Hospital pursuant to this Agreement and the obligations to prosecute and enforce such Intellectual Property Rights. |
3.3. |
The Hospital shall make itself available to sign any documents regarding the registration by patent authorities of the assignment of the Intellectual Property Rights and the Patent Applications and other similar documents which may be reasonably necessary to effectuate the assignment by the Hospital to the Company of the Intellectual Property Rights pursuant to this Agreement. Notwithstanding the above, the content and provisions of such documents shall not in any way conflict with the terms and conditions in this Agreement. All direct costs related thereto shall be held by the Company. |
4. |
THE LICENSE |
4.1. |
The License shall be irrevocable, non-exclusive, worldwide, perpetual and fully paid-up. The License shall include access and unrestricted use rights, within the scope of the terms and conditions of this Agreement, for the Company to any Clinical Data generated prior to the Execution Date. The Company acknowledges and agrees that the Hospital shall be entitled to keep one or more copies of the Clinical Data and to access and use any Clinical Data in any way it sees fit; however, solely for noncommercial research purposes. |
4.2. |
The Company shall only be entitled to access and use Clinical Data for the sole purpose of developing and commercializing the Inventions and/or the Intellectual Property Rights. |
5. |
CONSIDERATION |
5.1. |
The consideration to be paid by the Company to the Hospital for the rights granted to the Company pursuant to this Agreement shall consist of the payments to be made in accordance with this Section 5. [***] and shall be considered to be adequate consideration for the rights conferred upon the Company pursuant to this Agreement, both in respect of i) the assignment of Intellectual Property Rights and ii) the grant of the License. |
5.2. |
Milestone Payment |
5.2.1. |
In addition to any other payment to be made by the Company to the Hospital pursuant to this Agreement, the Company shall make the Milestone Payment [***] on any outstanding amount under the Milestone Payment calculated from the Effective Date until payment thereof. The payment of the Milestone Payment including accrued interests shall fall due as follows: |
6
5.2.1.1. |
[***]. |
5.2.1.2. |
[***] due upon submission by the Company of any CTA (Clinical Trial Application) or any IND (Investigational New Drug) application to any regulatory authority regarding a medicinal product which is within the scope of the Intellectual Property Rights and/or which is developed on the basis of any one or a combination of the Inventions and/or any Intellectual Property Right. |
5.2.1.3. |
[***] due upon achievement (as defined per industry standards) of the primary endpoint in a phase 2 clinical trial regarding a medicinal product which is within the scope of the Intellectual Property Rights and/or which is developed on the basis of any one or a combination of the Inventions and/or any Intellectual Property Right. |
5.2.1.4. |
[***]. |
5.2.1.5. |
Notwithstanding the above, any outstanding amount under the Milestone Payment including accrued interests shall be payable, in the discretion of the Company, at any time prior to any of the due dates mentioned above. |
5.3. |
Royalty Payments |
5.3.1. |
Furthermore, the Company shall [***] pay a Royalty Payment in cash corresponding to [***] of the Revenues and Sales generated in the preceding year. |
5.3.2. |
Subject to the due and complete fulfilment of the Companys obligations to manage, maintain, prosecute and enforce the Patent Applications in the Key Countries pursuant to Section 6.1, Royalty Payments under Section 5.3.1 shall only be payable for Revenues and Sales derived from a country or territory in which one or more Valid Claims exist. For clarity, in respect of Sales, the obligation to pay Royalty Payments shall be imposed only once per sale of a specific Product regardless of how many Valid Claims cover sales of such specific Product. |
5.3.3. |
The Company shall, upon the Hospitals request and at the Companys cost, provide the Hospital with all such documentation, materials and information as the Hospital may reasonably request in respect of the documentation for the Companys and/or any of its Affiliates or Related Parties receipt of Revenues and Sales. |
5.4. |
Final Payment |
5.4.1. |
At any time after the execution of this Agreement, the Company may settle any and all of the Hospitals rights to receive consideration pursuant to this Agreement by way of the effective payment to the Hospital of an amount of DKK 20,000,000 (say Danish Kroner twenty million 0/00) in the aggregate. If the Company exercises its right under this Section 5.4.1, the Final Payment to be paid by the Company shall be calculated as DKK 20,000,000 (say Danish Kroner twenty million 0/00) minus the aggregate Royalty Payments that have already been paid to the Hospital prior to the Companys exercise of its right under this Section 5.4.1. |
7
5.4.2. |
In the event that the Company makes the Final Payment pursuant to the above, the Hospital shall no longer be entitled to request the payment of any consideration pursuant to this Agreement, and all of the Companys obligations towards the Hospital pursuant to Sections 3.1, 5, and 6 shall automatically terminate. |
6. |
PATENT PROSECUTION AND ENFORCEMENT |
6.1. |
The Company shall use its best reasonable efforts to file all relevant patent applications in respect of the Intellectual Property Rights in i) all Key Countries and in ii) such other countries and territories where it would reasonably be deemed relevant and commercially viable to do so. The Company shall also use its best reasonable efforts to manage, maintain, prosecute and enforce the Intellectual Property Rights, including the Patent Applications, in all Key Countries and such other countries and the Company shall reasonably consult with the Hospital on a regular basis in relation to the management, maintenance, prosecution and enforcement of the Intellectual Property Rights, including the Patent Applications, and any patents issued on the basis thereof. The Company shall not abandon any patent application or patent included in or derived from the Intellectual Property Rights, including any of the Patent Applications, in any Key Country without the prior written consent of the Hospital, unless such patent or patent application does not contain any Valid Claim, or unless the Company reasonably demonstrates that the patent or patent application will be revoked or held unenforceable or invalid, or will be disallowed. Consent from the Hospital shall not be unreasonably withheld. |
6.2. |
At the request of the Company after the Execution Date, the Hospital shall provide the Company with access to any files and documents which are directly related to the Intellectual Property Rights and in the possession of the Hospital or, if reasonably possible, in the possession of the Hospitals external patent advisors. The Company shall pay any direct costs related to the above mentioned access. |
6.3. |
The Company shall provide the Hospital with all such information, documentation and materials which the Hospital may reasonably request after the Execution Date in respect of the Companys fulfilment of the Companys obligations pursuant to this Section 6. |
7. |
REPRESENTATIONS AND WARRANTIES |
7.1. |
The Hospital represents and warrants: |
7.1.1. |
That the Intellectual Property Rights are free and clear of any and all valid claims of ownership, liens, mortgages and encumbrances, including without limitation any valid claim of ownership from any inventor, Hospital employee or other Third Party under applicable law or internal Hospital regulations; and |
7.1.2. |
That no license or option rights regarding the Intellectual Property Rights are or have been granted to any Third Party by the Hospital. |
8
7.1.3. |
That, to the knowledge of the Hospital, as of the Execution Date there are no pending administrative or judicial proceedings contesting the inventorship, ownership, validity, or enforceability of any element of the Intellectual Property Rights. |
7.2. |
The Hospital gives no other representations or warranties than explicitly stated under Section 7 .1 with respect of any of the Intellectual Property Rights or any of the Inventions and nothing in this Agreement shall be construed either explicitly or implicitly: |
7.2.1. |
As a representation or warranty by the Hospital that any of the Intellectual Property Rights will proceed to grant; |
7.2.2. |
As a representation or warranty by the Hospital that utilizing and/or commercializing any part of any of the Inventions or any of the Intellectual Property Rights will not infringe the patents or other intellectual property rights of Third Parties or that the Company will not need to obtain or take out one or more licenses for any other rights from one or more Third Parties in order to utilize and/or commercialize one or more of the Inventions; |
7.2.3. |
As a representation or warranty by the Hospital that upon the Execution Date there are no administrative or judicial proceedings contesting the inventorship, ownership, validity, or enforceability of any element of the Intellectual Property Rights or that any such proceeding will not be initiated thereafter; |
7.2.4. |
As a representation or warranty by the Hospital that any of the Intellectual Property Rights or any of the Inventions or the use of the Clinical Data will lead to the development of any product; or |
7.2.5. |
As a representation or warranty by the Hospital as to the patentability, validity, scope, merchantability or usefulness of any of the Inventions and/or any of the Intellectual Property Rights and/or any Clinical Data. |
8. |
COVENANTS |
8.1. |
After the Execution Date and until the complete and due fulfilment of the Companys payment obligations pursuant to this Agreement, which entail the effective payment of all amounts which the Company is or shall be obligated to pay to the Hospital pursuant to this Agreement, and without prejudice to any of the other obligations imposed upon the Company under this Agreement, the Company undertakes to fully comply with the following obligations: |
8.1.1. |
That all of the Companys transactions with its Shareholders and their Affiliates and Related Parties shall be carried out on arms length terms and conditions; |
8.1.2. |
That the Company shall [***], at its own cost provide the Hospital with the documentation and information that the Hospital may reasonably request in respect of documentation for the Companys and/or any of its Affiliates or Related Parties receipt of Revenues and Sales; |
9
8.1.3. |
That the Company shall use all efforts required under Section 6 hereof to, at its own cost, manage, maintain, prosecute and enforce the Intellectual Property Rights pending or in force at any time; and |
8.1.4. |
That the Company shall not abandon any of the Patent Applications without first obtaining the consent of the Hospital. |
9. |
LIABILITY |
9.1. |
Each Party shall be liable in accordance with Danish law for damages, losses, costs or expenses sustained by the other Party as a result of, arising from or in connection with the first Partys breach of this Agreement. [***]. |
9.2. |
[***]. |
10. |
INDEMNIFICATION |
10.1. |
[***]. |
11. |
TERM AND TERMINATION |
11.1. |
This Agreement shall come into force on the Execution Date and shall be non-terminable. |
12. |
CONFIDENTIALITY |
12.1. |
The Parties shall not in any way disclose Confidential Information to any Third Party. |
12.2. |
The Parties shall use the same standards of care in keeping the other Partys Confidential Information confidential as they would use in respect of their own Confidential Information. Notwithstanding the foregoing, in no event shall the Parties be entitled to use a lower standard of care than a reasonable person would to protect its own confidential information. |
12.3. |
Notwithstanding anything to the contrary in this Agreement, the confidentiality obligations under this Section 12 shall not apply to Confidential Information which (1) becomes rightfully known to the receiving Party from a Third Party source without such Third Partys breach of confidentiality obligations towards the Party to whom the Confidential Information so disclosed pertains; (2) is or becomes publicly available through no fault of or failure to act by the receiving Party in breach of this Agreement; (3) is or has been independently developed by employees, consultants or agents of the receiving Party without violation of the terms of this Agreement or reference or access to any Confidential Information. |
12.4. |
To the extent that a Party discloses Confidential Information in accordance with binding resolutions or decisions made by competent legal authorities or in accordance with applicable laws and regulations requiring such disclosure of Confidential Information, the disclosing Party shall not be deemed to be in breach of its confidentiality obligations under this Agreement. Information disclosed pursuant to this Section 12.4 shall, however, remain Confidential Information for the purposes of this Agreement. |
10
12.5. |
In the event that a Party breaches its confidentiality obligations pursuant to this Section 12, such Party shall be liable to pay damages to the other Party in accordance with Danish law and the provisions of this Agreement. |
12.6. |
The restrictions on disclosure of Confidential Information shall not apply to a Partys disclosure of Confidential Information to its legal counsel and similar advisors who are bound by confidentiality obligations no less onerous than standard confidentiality obligations for such advisors. |
13. |
PUBLICATION |
13.1. |
The Company shall be entitled to publish at its discretion any information regarding the Intellectual Property Rights and the Clinical Data in order to further the Companys research, development and commercialization activities. |
13.2. |
The Hospital shall be entitled to publish information about any of the Inventions and any Intellectual Property Right and Clinical Data to the extent that such information is included in and covered by a patent application. |
13.3. |
The Hospital shall be entitled to publish any other information regarding the Intellectual Property Rights and the Clinical Data with the Companys prior written consent, which consent shall not be unreasonably withheld. |
13.4. |
The above restrictions on publication shall not in any way limit any rights to publish any information conferred by law upon employees of a Party which the Party is not legally entitled to restrict. [***]. |
14. |
MISCELLANEOUS |
14.1. |
This Agreement constitutes the entire understanding between the Parties and supersedes any and all prior or contemporaneous understandings and agreements, whether oral or written, between the Parties with respect to the subject matter hereof. This Agreement can only be modified by a written amendment signed by authorized representatives of both Parties. |
14.2. |
This Agreement shall be legally binding upon the Parties and the Parties shall enjoy the rights conferred and be subject to the obligations imposed upon them by this Agreement only upon and after such a time when both Parties have duly executed this Agreement by their respective authorized representatives. |
14.3. |
Neither Party shall be entitled to transfer any of its rights and/or obligations under this Agreement to any Third Party without the other Partys prior written consent. For clarity, the foregoing shall not restrict the Company from granting any license (or, with respect to the Clinical Data, any non-exclusive sublicense) to the Intellectual Property Rights and/or the Clinical Data to any Third Party. The Company, however, acknowledges and agrees |
11
that the Hospital is owned and operated by the Capital Region, that the Capital Region owns and operates multiple hospitals and that any of the hospitals or other legal entities owned and operated by the Capital Region (and the Capital Region itself) shall be entitled to exercise any and all of the rights conferred upon the Hospital pursuant to this Agreement. |
14.4. |
Nothing in this Agreement shall be construed so as to require the commission of any act contrary to applicable law, and wherever there is any conflict between any provision of this Agreement and any applicable law, the latter shall prevail. In the event that a provision of this Agreement is found by a court or institution of competent jurisdiction to be invalid, illegal or unenforceable and such decision by the court or institution cannot be or is not appealed in accordance with applicable law, such provision shall be modified, rewritten or interpreted to include as much of its nature and scope as will render it enforceable and only to the extent necessary to bring it within applicable law. If it cannot be so modified, rewritten or interpreted to be enforceable in any respect, it shall not be given effect, and the remainder of the Agreement shall be enforced as if such provision was not included. |
14.5. |
Any failure by either Party to enforce the other Partys strict performance of any provision of this Agreement shall not constitute a waiver of the former Partys right to subsequently enforce such provision or any other provision of this Agreement. |
14.6. |
Notices required or permitted to be given under this Agreement shall be in writing and shall be sent to the addresses mentioned below or to such other addresses as may be designated by the receiving Party from time to time: |
14.7. |
Neither Party is or shall be deemed to be an employee, agent or legal representative of the other Party due to the execution or implementation of this Agreement, the performance of any obligations imposed or the enjoyment of any rights conferred by this Agreement. |
14.8. |
Neither Party to this Agreement shall commit any act or take any action frustrating or hampering the rights of the other Party under this Agreement. Each Party shall act in good faith and engage in fair dealing when taking any action under or related to this Agreement. |
15. |
GOVERNING LAW AND VENUE |
15.1. |
This Agreement shall be governed by, construed and enforced in accordance with the laws of Denmark, excluding however Danish choice of law rules to the extent that such rules would otherwise lead to the application of any other law than Danish law. |
12
15.2. |
In the event of a dispute between the Parties related to this Agreement, hereunder but not limited to the existence, validity, interpretation, and/or performance of any provision of this Agreement, the Parties shall seek to settle the dispute by negotiations in good faith with an aim to resolve the dispute. Such negotiations shall be commenced by a Party submitting a written request to the other Party requesting such negotiations to commence. |
15.3. |
In the event that such negotiations do not lead to a settlement of the dispute within 4 weeks from the commencement thereof, and only then, the Parties submit to the exclusive jurisdiction of the city court of Copenhagen in the first instance to resolve any dispute between them. Any decision made or verdict rendered by such court shall be subject to appeal in accordance with applicable law. |
-000-
(signature page follows)
13
SIGNATURES |
For and on behalf of Herlev and Gentofte Hospital |
Date: 12/28/2016 |
/s/ Steen Werner Hansen |
Name: Steen Werner Hansen |
Title: Deputy Chief Executive |
For and on behalf of IO Biotech ApS | ||||
Date: 1/2/2017 | Date: 1/2/2017 | |||
/s/ Mai-Britt Zocca | /s/ Peter Hirth | |||
Name: Mai-Britt Zocca | Name: Peter Hirth | |||
Title: Managing Director | Title: Chairman |
14
Exhibit 10.8
*Portions of this exhibit have been excluded because it both (i) is not material and (ii)
would be competitively harmful if publicly disclosed.
OPTION ASSIGNMENT AGREEMENT
BETWEEN
HERLEV AND GENTOFTE HOSPITAL
AND
IO BIOTECH ApS
(Option on assignment of Arginase 1)
On 27 March, 2017, the following parties
Herlev and Gentofte Hospital
[***]
(hereinafter referred to as Hospital)
and
IO Biotech ApS
[***]
(hereinafter referred to as the Company)
(hereinafter collectively referred to as the Parties and individually as a Party)
have entered into this option assignment agreement regarding the grant by the Hospital to the Company of an option to acquire certain intellectual property rights on the terms and conditions set out in the following.
RECITALS
(A) |
WHEREAS the Hospital is a hospital owned and operated by the Capital Region of Denmark (in Danish: Hovedstadsregionen) performing research and providing medical treatment of patients within various medical fields; |
(B) |
WHEREAS the Hospital inter alia employs researchers, scientists, doctors and other personnel within the medical field who, during and related to their employment at the Hospital, may make inventions within their field of expertise; |
(C) |
WHEREAS [***] has made a certain invention referred to as Arginase specific T cells: Novel opportunities for the targeting of immunosuppressive cells in cancer; |
(D) |
WHEREAS the Hospital has acquired and taken over the intellectual property rights and title in and to said inventions pursuant to the Danish Act on Inventions at Public Research Institutions; |
(E) |
WHEREAS the Hospital thereafter holds all of the intellectual property rights and title in and to said inventions; |
(F) |
WHEREAS the Company is a limited liability company incorporated under Danish law performing research and experimental development within the field of biotechnology whose purpose is to develop a vaccine targeting immune inhibiting cells for the purpose of prevention and/or treatment of cancer, and/or to pursue related activities as per board discretion; |
(G) |
WHEREAS the Company has expressed its desire to acquire the patent rights to the inventions covered by this option assignment agreement; and |
1
(H) |
WHEREAS such acquisition will be to the benefit of the development of the inventions covered by this option assignment agreement and of the research to be performed within the medical field to which such inventions pertain; |
NOW THEREFORE, the Parties have entered into this option assignment agreement on the following terms and conditions:
1. |
DEFINITIONS |
1.1. |
In this assignment agreement, the following expressions and words shall have the following meanings: |
1.1.1. |
Agreement shall mean this assignment agreement with Exhibits, if any. |
1.1.2. |
Affiliate shall mean any legal entity directly or indirectly Controlling, Controlled by, or under common Control with the entity in question, for as long as such Control lasts. |
1.1.3. |
Assignee shall mean a Third Party to whom the Company by any means transfers Intellectual Property Rights (however, not including by way of the grant of a license in Intellectual Property Rights). |
1.1.4. |
Capital Region shall mean the Capital Region of Denmark (in Danish: Region Hovedstaden), [***]. |
1.1.5. |
Clinical Data shall mean the data specifically generated in connection with or leading up to and used in the studies and research connected with the making or the development of the Invention either prior to or after the Execution Date, which studies and research are set out in Exhibit 1. |
1.1.6. |
Confidential Information shall mean all information which i) a Party has specifically designated as confidential, which ii) pertains to a general type of information which a Party has specifically designated as confidential or which iii) would otherwise reasonably be deemed as confidential. |
1.1.7. |
Control (including Controlling and Controlled) shall mean direct or indirect control of the entity in question through: |
1.1.7.1. |
direct or indirect control or ownership of more than fifty percent (50 %) of either i) the nominal value of the equity capital of the entity or ii) the voting rights of the equity capital of the entity. |
1.1.7.2. |
a right or cumulative rights by any other means to elect or appoint directors or officers of the entity, or persons performing similar functions, who have a majority vote. |
1.1.8. |
Covenant shall mean any of the obligations of the Company towards the Hospital set out in Section 8.1. |
1.1.9. |
Execution Date shall mean the date of the last signature to this Agreement. |
2
1.1.10. |
Exercise Date shall mean the date upon which the Company duly exercises the Option in accordance with this Agreement. |
1.1.11. |
Exercise Period shall mean [***]. |
1.1.12. |
Exhibit shall mean any exhibit to this Agreement. |
1.1.13. |
Exit shall mean one of the following events taking place after the Execution Date: (i) an initial public offering (IPO), whether directly or through holding or other ownership structures, of all or part of the Companys Shares, or of all or part of the shares of a company Controlling the Company; (ii) transfer of Control of the Company, or of Control of a company Controlling the Company, whether directly or through holding or other ownership structures, to any person or legal entity (including transfer of a noncontrolling interest whereby any person or legal entity obtains Control of the Company or of a company Controlling the Company); (iii) a transfer to a Third Party, whether by sale, the grant of a license or by any other means, of all or a material part of the Companys assets if such transaction implies that the Company ceases to operate as an active company with substantial on-going research and/or business activities; (iv) solvent liquidation or winding up of the Company, (v) a merger or de-merger in which the Company or a company Controlling the Company is the discontinuing entity, or (vi) any combination of the above, which can reasonably be considered equal to an Exit, including two or more of the events mentioned above which, considered alone, cannot reasonably be considered as an Exit but which, considered together, can reasonably be considered as a coherent series of events constituting an Exit. |
1.1.14. |
Final Payment shall mean the payment to be made at the discretion of the Company to the Hospital in accordance with Section 5.4. |
1.1.15. |
Intellectual Property Rights shall mean all of the Hospitals intellectual property rights and title in and to the Patent Application and any patent issued or to be issued deriving priority from the Patent Application, including any provisionals, nonprovisionals, divisions, revisions, extensions, continuations, continuations-in-part and substitutions derived from the Patent Application or from any such patent issued or to be issued and any reissues of such patents and all intellectual property rights in any patent applications to be filed pursuant to this Agreement. |
1.1.16. |
Invention shall mean the invention referred to as Arginase specific T cells: Novel opportunities for the targeting of immunosuppressive cells in cancer which is described in the Patent Application. |
1.1.17. |
Key Country shall mean any of the countries and territories listed in Exhibit 2. |
1.1.18. |
License shall mean a non-exclusive license to access and use Clinical Data in accordance with the terms and conditions set out in this Agreement. |
1.1.19. |
Milestone Payment shall mean the payment of an amount equalling [***]. |
3
1.1.20. |
Option shall mean the option granted by the Hospital to the Company pursuant to this Agreement to acquire the Hospitals full and complete title and ownership in and to all of the Intellectual Property Rights on the terms and conditions set out in this Agreement. |
1.1.21. |
Patent Application shall mean the patent application filed under patent application number [***]. |
1.1.22. |
Product shall mean any product which is within the scope of the Intellectual Property Rights and any product which is developed on the basis of the Invention and/or any Intellectual Property Right and which is sold by the Company or any of its Affiliates or Related Parties. |
1.1.23. |
Related Party shall have the meaning ascribed to the term nærstående in section 2 of the Danish Bankruptcy Act. |
1.1.24. |
Representations and Warranties shall mean the representations and warranties issued by the Hospital in accordance with Section 7.1. |
1.1.25. |
Revenues shall mean the aggregate amount of (i) any payment (excluding value added tax and any other applicable taxes and duties) paid to the Company and any of its Affiliates and Related Parties and (ii) the value of any non-monetary receipt obtained by the Company and any of its Affiliates and Related Parties, and derived from the use of or based on the Invention, including if used in combination with any other invention or pharmaceutical, or in relation to or based on any Intellectual Property Right. Revenues include without limitation license fees (or sublicense fees, if applicable), option fees, down payments, milestone payments, royalties, service fees and other fees and similar types of payments and any other payments generated from the development and/or commercialization of the Invention (also if used in combination with any other invention or pharmaceutical) and/or any Intellectual Property Right or from the assignment or other type of transfer to a Third Party of the Invention and/or any Intellectual Property Right. For clarity, it is expressly understood that Revenues shall not include any Sales. |
1.1.26. |
Royalty Payment shall mean any payment to be made by the Company to the Hospital pursuant to Section 5.3. |
1.1.27. |
Sales shall mean the invoiced price of Products sold by and paid to the Company and any of its Affiliates and Related Parties in arms length transactions exclusively for money or, where the sale is not at arms length or not exclusively for money, the price that would have been so invoiced if it had been at arms length exclusively for money, after deduction of all documented: |
(a) |
normal trade discounts which are actually granted and any credits actually given for rejected or returned Products to the extent that such discounts and credits are reasonable and customary in the applicable market; |
(b) |
costs of packaging, insurance, carriage, and freight, provided in each case that the amounts are separately charged on the relevant invoice and only to the extent that such costs are reasonable and customary in the applicable market; |
4
(c) |
mandatory value added tax or other applicable and mandatory sales tax; and |
(d) |
mandatory import duties or similar applicable mandatory government levies. |
1.1.28. |
Section shall mean a provision of this Agreement (excluding the Exhibits) defined by a number. |
1.1.29. |
Shareholder shall mean any physical person and any legal entity holding Shares in the Company. |
1.1.30. |
Shares shall mean shares issued by the Company and other financial instruments (e.g. warrants, convertible loans and other instruments which comprise a right to acquire new or existing shares in the Company, which right may be conditional) issued by the Company. |
1.1.31. |
Third Party shall mean any person or entity other than the Parties. |
1.1.32. |
Valid Claim shall mean (a) in the case of an issued and unexpired patent under the Intellectual Property Rights, a claim that has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (b) in the case of a pending patent application, a pending claim that has not been cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or refiling of such application. |
1.2. |
The singular shall, where the context does not exclude it, include the plural and vice versa. |
2. |
GRANT OF THE OPTION AND THE LICENSE |
2.1. |
Subject to the terms and conditions set out in this Agreement, the Hospital hereby grants the Option and the License to the Company. |
2.2. |
The consideration to be paid to the Hospital for the grant of the Option and the License is set out in Section 5. |
3. |
EXERCISE OF THE OPTION |
3.1. |
The Company shall be entitled to exercise the Option at any time during the Exercise Period by issuing a written notice to the Hospital stating that the Company is exercising the Option. |
3.2. |
Upon the Companys due exercise of the Option, the Company shall be deemed to have acquired from the Hospital and the Hospital to have assigned to the Company the Intellectual Property Rights on the terms and conditions set out in this Agreement. |
5
3.3. |
The Hospital shall make itself available to sign any documents regarding the registration by patent authorities of the assignment of the Patent Application and other similar documents which may be reasonably necessary to effectuate the assignment of the Intellectual Property Rights by the Hospital to the Company pursuant to this Agreement. Notwithstanding the above, the content and provisions of such documents shall not in any way conflict with the terms and conditions in this Agreement. All direct costs related thereto shall be paid by the Company. |
3.4. |
In the event that the Company does not duly exercise the Option in accordance with this Agreement during the Exercise Period or if the Company notifies the Hospital during the Exercise Period that it will not exercise the Option, the Option shall automatically lapse and shall no longer be in effect. In such event, and irrespective of any payment made by the Company under this Agreement (including payments of Patent Costs) the Hospital shall then retain all Intellectual Property Rights free of any commitments to the Company. |
3.5. |
After having duly exercised the Option in accordance with this Agreement, the Company shall only be entitled to transfer Intellectual Property Rights to an Assignee in the event that i) the Company has made the Milestone Payment, including accrued interests, cf. Section 5.2.1, and that ii) the Assignee in question assumes the Companys obligations towards the Hospital pursuant to this Agreement to make Royalty Payments and to prosecute and enforce the Intellectual Property Rights. |
3.6. |
In the event that the Company transfers Intellectual Property Rights to an Assignee pursuant to the above and the Company and/or a Company Affiliate and/or a Related Party later acquires such Intellectual Property Rights from the same Assignee or another Third Party, the Company shall re-assume the payment obligations towards the Hospital pursuant to this Agreement and the obligations to prosecute and enforce such Intellectual Property Rights. |
4. |
THE LICENSE |
4.1. |
The License shall be irrevocable, non-exclusive, worldwide, perpetual and fully paid up. The License shall include access and unrestricted use rights, within the scope of the terms and conditions of this Agreement, for the Company to any Clinical Data generated prior to the Exercise Date. The Company acknowledges and agrees that the Hospital shall be entitled to keep one or more copies of the Clinical Data and to access and use any Clinical Data in any way it sees fit for non-commercial research purposes. |
4.2. |
The Company shall only be entitled to access and use Clinical Data for the sole purpose of developing and commercializing the Invention and/or the Intellectual Property Rights. |
5. |
CONSIDERATION |
5.1. |
The consideration to be paid by the Company to the Hospital for the grant of the Option and the grant of the License pursuant to this Agreement shall consist of the payments to be made in accordance with this Section 5. [***] and shall be considered to be adequate consideration for the grant of the Option and the grant of the License pursuant to this Agreement. |
6
5.2. |
Milestone Payment |
5.2.1. |
In addition to any other payment to be made by the Company to the Hospital pursuant to this Agreement, the Company shall make the Milestone Payment [***] on any outstanding amount under the Milestone Payment calculated from the Execution Date until payment thereof. The payment of the Milestone Payment including accrued interests shall fall due as follows: |
5.2.1.1. |
[***]. |
5.2.1.2. |
[***] due upon submission by the Company of any CTA (Clinical Trial Application) or any IND (Investigational New Drug) application to any regulatory authority regarding a medicinal product which is within the scope of the Intellectual Property Rights and/or which is developed on the basis of the Invention and/or any Intellectual Property Right. |
5.2.1.3. |
[***] due upon achievement (as defined per industry standards) of the primary endpoint in a phase 2 clinical trial regarding a medicinal product which is within the scope of the Intellectual Property Rights and/or which is developed on the basis the Invention and/or any Intellectual Property Right. |
5.2.1.4. |
[***]. |
5.2.1.5. |
Notwithstanding the above, any outstanding amount under the Milestone Payment including accrued interests shall be payable, in the discretion of the Company, at any time prior to any of the due dates mentioned above. |
5.3. |
Royalty Payments |
5.3.1. |
Furthermore, the Company shall [***] pay a Royalty Payment in cash corresponding to [***] of the Revenues and Sales generated in the preceding year. |
5.3.2. |
Subject to the due and complete fulfilment of the Companys obligations to manage, maintain, prosecute and enforce the Patent Application in the Key Countries pursuant to Section 6.2, Royalty Payments under Section 5.3.1 shall only be payable for Revenues and Sales derived from a country or territory in which one or more Valid Claims exist. For clarity, in respect of Sales, the obligation to pay Royalty Payments shall be imposed only once per sale of a specific Product regardless of how many Valid Claims cover sales of such specific Product. |
5.3.3. |
The Company shall, upon the Hospitals request and at the Companys cost, provide the Hospital with all such documentation, materials and information as the Hospital may reasonably request in respect of the documentation for the Companys and/or any of its Affiliates or Related Parties receipt of Revenues and Sales. |
7
5.4. |
Final Payment |
5.4.1. |
At any time after the execution of this Agreement, the Company may settle any and all of the Hospitals rights to receive consideration pursuant to this Agreement by way of the effective payment to the Hospital of an amount of DKK 10,000,000 (say Danish Kroner ten million 0/00) in the aggregate. If the Company exercises its right under this Section 5.4.1, the Final Payment to be paid by the Company shall be calculated as DKK 10,000,000 (say Danish Kroner ten million 0/00) minus the aggregate Royalty Payments that have already been paid to the Hospital prior to the Companys exercise of its right under this Section 5.4.1. |
5.4.2. |
In the event that the Company makes the Final Payment pursuant to the above, the Hospital shall no longer be entitled to request the payment of any consideration pursuant to this Agreement, and all of the Companys obligations towards the Hospital pursuant to Sections 3.5, 5, and 6 shall automatically terminate. |
6. |
PATENT PROSECUTION AND ENFORCEMENT |
6.1. |
Until the earlier of i) the Companys exercise of the Option or ii) the lapse of the Option in accordance with this Agreement, the Hospital shall manage, maintain and prosecute the Patent Application in the territories in which it may have been filed. |
6.2. |
After having duly exercised the Option in accordance with this Agreement, the Company shall use its best reasonable efforts to file all relevant patent applications in respect of the Intellectual Property Rights in i) all Key Countries and in ii) such other countries and territories where it would reasonably be deemed relevant and commercially viable to do so. The Company shall also use its best reasonable efforts to manage, maintain, prosecute and enforce the Intellectual Property Rights, including the Patent Application, in all Key Countries and such other countries and territories and the Company shall reasonably consult with the Hospital on a regular basis in relation to the management, maintenance, prosecution and enforcement of the Intellectual Property Rights, including the Patent Application, and any patents issued on the basis thereof. The Company shall not abandon any patent application or patent included in or derived from the Intellectual Property Rights, including the Patent Application, in any Key Country without the prior written consent of the Hospital, unless such patent or patent application does not contain any Valid Claim, or unless the Company reasonably demonstrates that the patent or patent application will be revoked or held unenforceable or invalid, or will be disallowed. Consent from the Hospital shall not be unreasonably withheld. |
6.3. |
At the request of the Company after the Exercise Date, the Hospital shall provide the Company with access to any files and documents which are directly related to the Intellectual Property Rights and in the possession of the Hospital or, if reasonably possible, in the possession of the Hospitals external patent advisors. The Company shall pay any direct costs related to the above mentioned access. |
6.4. |
The Company shall provide the Hospital with all such information, documentation and materials which the Hospital may reasonably request after the Exercise Date in respect of the Companys fulfilment of the Companys obligations pursuant to this Section 6. |
8
7. |
REPRESENTATIONS AND WARRANTIES |
7.1. |
The Hospital represents and warrants: |
7.1.1. |
That the Intellectual Property Rights are free and clear of any and all valid claims of ownership, liens, mortgages and encumbrances, including without limitation any valid claim of ownership from any inventor, Hospital employee or other Third Party under applicable law or internal Hospital regulations; and |
7.1.2. |
That no license or option rights regarding the Intellectual Property Rights are or have been granted to any Third Party by the Hospital. |
7.1.3. |
That, to the knowledge of the Hospital, as of the Execution Date there are no pending administrative or judicial proceedings contesting the inventorship, ownership, validity, or enforceability of any element of the Intellectual Property Rights. |
7.2. |
The Hospital gives no other representations or warranties than explicitly stated under Section 7 .1 with respect of any of the Intellectual Property Rights or the Invention and nothing in this Agreement shall be construed either explicitly or implicitly: |
7.2.1. |
As a representation or warranty by the Hospital that any of the Intellectual Property Rights will proceed to grant; |
7.2.2. |
As a representation or warranty by the Hospital that utilizing and/or commercializing any part of the Invention or any of the Intellectual Property Rights will not infringe the patents or other intellectual property rights of Third Parties or that the Company will not need to obtain or take out one or more licenses for any other rights from one or more Third Parties in order to utilize and/or commercialize the Invention; |
7.2.3. |
As a representation or warranty by the Hospital that upon the Execution Date there are no administrative or judicial proceedings contesting the inventorship, ownership, validity, or enforceability of any element of the Intellectual Property Rights or that any such proceeding will not be initiated thereafter; |
7.2.4. |
As a representation or warranty by the Hospital that any of the Intellectual Property Rights or the Invention or the use of the Clinical Data will lead to the development of any product; or |
7.2.5. |
As a representation or warranty by the Hospital as to the patentability, validity, scope, merchantability or usefulness of the Invention and/or any of the Intellectual Property Rights and/or any Clinical Data. |
8. |
COVENANTS |
8.1. |
After the Execution Date and until the complete and due fulfilment of the Companys payment obligations pursuant to this Agreement, which entail the effective payment of all amounts which the Company is or shall be obligated to pay to the Hospital pursuant to this Agreement, and without prejudice to any of the other obligations imposed upon the Company under this Agreement, the Company undertakes to fully comply with the following obligations: |
8.1.1. |
That all of the Companys transactions with its Shareholders and their Affiliates and Related Parties shall be carried out on arms length terms and conditions; |
9
8.1.2. |
That the Company shall [***], at its own cost provide the Hospital with the documentation and information that the Hospital may reasonably request in respect of documentation for the Companys and/or any of its Affiliates or Related Parties receipt of Revenues and Sales; |
8.1.3. |
That the Company shall use all efforts required under Section 6 to, at its own cost, manage, maintain, prosecute and enforce the Intellectual Property Rights pending or in force at any time; and |
8.1.4. |
That the Company shall not abandon the Patent Application without first obtaining the consent of the Hospital. |
9. |
LIABILITY |
9.1. |
Each Party shall be liable in accordance with Danish law for damages, losses, costs or expenses sustained by the other Party as a result of, arising from or in connection with the first Partys breach of this Agreement. [***]. |
9.2. |
[***]. |
10. |
INDEMNIFICATION |
10.1. |
[***]. |
11. |
TERM AND TERMINATION |
11.1. |
This Agreement shall come into force on the Execution Date and shall be non-terminable. |
12. |
CONFIDENTIALITY |
12.1. |
The Parties shall not in any way disclose Confidential Information to any Third Party. |
12.2. |
The Parties shall use the same standards of care in keeping the other Partys Confidential Information confidential as they would use in respect of their own Confidential Information. Notwithstanding the foregoing, in no event shall the Parties be entitled to use a lower standard of care than a reasonable person would to protect its own confidential information. |
12.3. |
Notwithstanding anything to the contrary in this Agreement, the confidentiality obligations under this Section 12 shall not apply to Confidential Information which (1) becomes rightfully known to the receiving Party from a Third Party source without such Third Partys breach of confidentiality obligations towards the Party to whom the Confidential Information so disclosed pertains; (2) is or becomes publicly available through no fault of or failure to act by the receiving Party in breach of this Agreement; (3) is or has been independently developed by employees, consultants or agents of the receiving Party without violation of the terms of this Agreement or reference or access to any Confidential Information. |
10
12.4. |
To the extent that a Party discloses Confidential Information in accordance with binding resolutions or decisions made by competent legal authorities or in accordance with applicable laws and regulations requiring such disclosure of Confidential Information, the disclosing Party shall not be deemed to be in breach of its confidentiality obligations under this Agreement. Information disclosed pursuant to this Section 12.4 shall, however, remain Confidential Information for the purposes of this Agreement. |
12.5. |
In the event that a Party breaches its confidentiality obligations pursuant to this Section 12, such Party shall be liable to pay damages to the other Party in accordance with Danish law and the provisions of this Agreement. |
12.6. |
The restrictions on disclosure of Confidential Information shall not apply to a Partys disclosure of Confidential Information to its legal counsel and similar advisors who are bound by confidentiality obligations no less onerous than standard confidentiality obligations for such advisors. Furthermore, acknowledging that the University of Copenhagen, Denmark, from 1 March 2017 will handle all matters related to the commercialization of inventions made by employees of the Capital Region, the Company agrees and acknowledges that the restrictions on disclosure of Confidential Information pursuant to this Agreement shall not apply to the Hospitals disclosure thereof to the University of Copenhagen to the extent that such disclosure is necessary for the handling of such matters by the University of Copenhagen, Denmark. |
13. |
PUBLICATION |
13.1. |
The Company shall be entitled to publish at its discretion any information regarding the Intellectual Property Rights and the Clinical Data in order to further the Companys research, development and commercialization activities. |
13.2. |
The Hospital shall be entitled to publish information about the Invention and any Intellectual Property Right and Clinical Data to the extent that such information is included in and covered by a patent application. |
13.3. |
The Hospital shall be entitled to publish any other information regarding the Intellectual Property Rights and the Clinical Data with the Companys prior written consent, which consent shall not be unreasonably withheld. |
13.4. |
The above restrictions on publication shall not in any way limit any rights to publish any information conferred by law upon employees of a Party which the Party is not legally entitled to restrict. [***]. |
14. |
MISCELLANEOUS |
14.1. |
This Agreement constitutes the entire understanding between the Parties and supersedes any and all prior or contemporaneous understandings and agreements, whether oral or written, between the Parties with respect to the subject matter hereof. This Agreement can only be modified by a written amendment signed by authorized representatives of both Parties. |
11
14.2. |
This Agreement shall be legally binding upon the Parties and the Parties shall enjoy the rights conferred and be subject to the obligations imposed upon them by this Agreement only upon and after such a time when both Parties have duly executed this Agreement by their respective authorized representatives. |
14.3. |
Neither Party shall be entitled to transfer any of its rights and/or obligations under this Agreement to any Third Party without the other Partys prior written consent. For clarity, the foregoing shall not restrict the Company from granting any license in the Intellectual Property Rights or any sublicense in the Clinical Data to any Third Party. The Company, however, acknowledges and agrees that the Hospital is owned and operated by the Capital Region, that the Capital Region owns and operates multiple hospitals and that any of the hospitals or other legal entities owned and operated by the Capital Region (and the Capital Region itself) shall be entitled to exercise any and all of the rights conferred upon the Hospital pursuant to this Agreement. |
14.4. |
Nothing in this Agreement shall be construed so as to require the commission of any act contrary to applicable law, and wherever there is any conflict between any provision of this Agreement and any applicable law, the latter shall prevail. In the event that a provision of this Agreement is found by a court or institution of competent jurisdiction to be invalid, illegal or unenforceable and such decision by the court or institution cannot be or is not appealed in accordance with applicable law, such provision shall be modified, rewritten or interpreted to include as much of its nature and scope as will render it enforceable and only to the extent necessary to bring it within applicable law. If it cannot be so modified, rewritten or interpreted to be enforceable in any respect, it shall not be given effect, and the remainder of the Agreement shall be enforced as if such provision was not included. |
14.5. |
Any failure by either Party to enforce the other Partys strict performance of any provision of this Agreement shall not constitute a waiver of the former Partys right to subsequently enforce such provision or any other provision of this Agreement. |
14.6. |
Notices required or permitted to be given under this Agreement shall be in writing and shall be sent to the addresses mentioned below or to such other addresses as may be designated by the receiving Party from time to time: |
12
14.7. |
Neither Party is or shall be deemed to be an employee, agent or legal representative of the other Party due to the execution or implementation of this Agreement, the performance of any obligations imposed or the enjoyment of any rights conferred by this Agreement. |
14.8. |
Neither Party to this Agreement shall commit any act or take any action frustrating or hampering the rights of the other Party under this Agreement. Each Party shall act in good faith and engage in fair dealing when taking any action under or related to this Agreement. |
15. |
GOVERNING LAW AND VENUE |
15.1. |
This Agreement shall be governed by, construed and enforced in accordance with the laws of Denmark, excluding however Danish choice of law rules to the extent that such rules would otherwise lead to the application of any other law than Danish law. |
15.2. |
In the event of a dispute between the Parties related to this Agreement, hereunder but not limited to the existence, validity, interpretation, and/or performance of any provision of this Agreement, the Parties shall seek to settle the dispute by negotiations in good faith with an aim to resolve the dispute. Such negotiations shall be commenced by a Party submitting a written request to the other Party requesting such negotiations to commence. |
15.3. |
In the event that such negotiations do not lead to a settlement of the dispute within 4 weeks from the commencement thereof, and only then, the Parties submit to the exclusive jurisdiction of the city court of Copenhagen in the first instance to resolve any dispute between them. Any decision made or verdict rendered by such court shall be subject to appeal in accordance with applicable law. |
---000---
(signature page follows)
13
SIGNATURES |
For and on behalf of Herlev and Gentofte Hospital |
Date: 3/27/2017 |
/s/ Steen Werner Hansen |
Name: Steen Werner Hansen Title: Deputy Chief Executive |
For and on behalf of IO Biotech ApS
Date: 3/1/2017
/s/ Mai-Britt Zocca |
Date: 3/1/2017
/s/ Peter Hirth |
|||
|
|
|||
Name: Mai-Britt Zocca
Title: Managing Director |
Name: Peter Hirth
Title: Chairman |
14
Exhibit 10.9
*Portions of this exhibit have been excluded because it both (i) is not material and (ii)
would be competitively harmful if publicly disclosed.
1st AMENDMENT TO
OPTION ASSIGNMENT AGREEMENT
BETWEEN
HERLEV AND GENTOFTE HOSPITAL
AND
IO BIOTECH ApS
(1st amendment to Option Assignment Agreement of Arginase 1)
On December 7th 2018, the following parties
Herlev and Gentofte Hospital
[***]
(hereinafter referred to as Herlev Hospital)
and
IO Biotech ApS
[***]
(hereinafter referred to as the Company)
(hereinafter all the above mentioned parties collectively referred to as the Parties and individually as a Party)
have entered into this amendment to the assignment agreement entered into between the Parties on 27 March 2017 regarding the grant by the Hospitals to the Company of an option to acquire certain intellectual property rights.
RECITALS
(A) |
WHEREAS the Parties on 27 March 2017 have entered into an option assignment agreement (hereinafter referred to as the Agreement) setting out the terms and conditions for the Companys exercise of an option to acquire certain Intellectual Property Rights in and to an invention referred to as Arginase 1; |
(B) |
WHEREAS this Amendment only amends the patent Application number referenced in Agreement under point 1.1.21; |
NOW THEREFORE, the Parties have entered into this Amendment where the Patent Application number is updated with the PA number:
1.1.1 |
PATENT APPLICATION shall mean the patent application filed under the application number [***] with international application number [***]. |
___000___
(signature page follows)
1
SIGNATURES
For and on behalf of Herlev and Gentofte Hospital Date
Date: 12/7/2018 |
/s/ Steen Werner Hansen |
Name: Steen Werner Hansen Title: Deputy Chief Executive |
For and on behalf of IO Biotech ApS |
Date: 12/5/2018 |
/s/ Mai-Britt Zocca |
Name: Mai-Britt Zocca Title: CEO |
2
Exhibit 10.10
2nd AMENDMENT TO
OPTION ASSIGNMENT AGREEMENT
BETWEEN
HERLEV AND GENTOFTE HOSPITAL
AND
IO BIOTECH ApS
(Assignment of Arginase 1)
On 7 December 2018, the following parties
Herlev and Gentofte Hospital
[***]
(hereinafter referred to as the Hospital)
and
IO Biotech ApS
[***]
(hereinafter referred to as the Company)
(hereinafter collectively referred to as the Parties and individually as a Party)
have entered into this amendment to the assignment agreement entered into between the Parties on 27 March 2017 regarding the grant by the Hospital to the Company of an option to acquire certain intellectual property rights.
RECITALS
(A) |
WHEREAS the Parties on 27 March 2017 have entered into an option assignment agreement (hereinafter referred to as the Agreement) setting out the terms and conditions for the Companys exercise of an option to acquire certain Intellectual Property Rights in and to an invention referred to as Arginase 1; |
(B) |
WHEREAS the definitions used in the Agreement shall also apply to this Amendment; |
(C) |
WHEREAS the Company wishes to exercise the Option; |
(D) |
WHEREAS the Company also wishes to exercise certain other options granted to the Company by the Hospital in respect of certain other intellectual property rights in certain other inventions; |
(E) |
WHEREAS, notwithstanding the terms and conditions set out in the Agreement, the Parties agree that the Company shall exercise the Option on the terms and conditions set out in the Agreement but as amended by the provisions of this Amendment; and |
(F) |
WHEREAS this Amendment only amends the Companys obligations to make the Milestone Payments; |
NOW THEREFORE, the Parties have entered into this Amendment on the following terms and conditions:
1, |
ACQUISITION AND CONSIDERATION |
1.1. |
Subject to the terms and conditions set out in the Agreement as amended by this Amendment, the Company hereby exercises the Option and the Hospital hereby assigns its full and complete title and ownership in and to all of the Intellectual Property Rights to the Company. |
2. |
MISCELLANEOUS |
2.1. |
The Parties agree that the Companys obligations under Section 6 of the Agreement shall only apply to the extent that It would reasonably be deemed by the Company to be commercially viable to pursue such prosecution and enforcement of the Intellectual Property Rights. |
2.2. |
This Amendment shall come into force on the date of the Parties due execution hereof and shall be non-terminable. |
2.3. |
All provisions of the Agreement not clearly or expressly deviated from or amended in this Amendment, shall retain their full force and effect given to them under the Agreement and shall continue to apply as between the Parties in accordance with the Agreement. |
SIGNATURES |
For and on behalf of Herlev and Gentofte Hospital |
Date: 7/12/18 |
/s/ Steen Werner Hansen |
Name: Steen Werner Hansen |
Title: Deputy Chief Executive |
For and on behalf of IO Biotech ApS |
Date: 5/12/18 |
/s/ Mai-Britt Zocca |
Name: Mai-Britt Zocca |
Title:CEO |
Exhibit 10.11
Execution version
Agreement on Payment for Specific Services
IO Biotech ApS and Herlev og Gentofte Hospital
This agreement (the Agreement) is made on 27 January 2021 between
IO Biotech ApS
[***]
(the Company)
and
Herlev og Gentofte Hospital
[***]
(the Hospital)
(the Company and the Hospital hereinafter collectively referred to as the Parties and each as a Party)
WHEREAS
A. |
The Parties have entered into certain agreements, including, without limitation: |
(i) |
an option assignment agreement dated 2 January 2015 regarding the grant by the Hospital to the Company of an option to acquire certain intellectual property rights, which option the Company subsequently exercised, |
(ii) |
a framework assignment agreement dated 2 May 2016 regarding the potential assignment from the Hospital to the Company of intellectual property rights and title in and to certain inventions, |
(iii) |
an assignment agreement dated 2 January 2017 regarding the assignment by the Hospital to the Company of certain intellectual property rights, |
(iv) |
a framework cooperation agreement dated 2 January 2017 regarding the potential cooperation between the Parties in respect of cofinanced research and commissioned research, and |
(v) |
a cooperation agreement dated 24 March 2017 regarding the cooperation between the Parties in respect of cofinanced research regarding Melanoma Trial (the Melanoma Trial) |
Page: 2 of 8
(such agreements together with any other agreements and understandings between the Parties in force as of the date of this Agreement hereinafter collectively referred to as the Principal Agreements); |
B. |
The Parties are each subject to various rights and obligations pursuant to the Principal Agreements, including, without limitation, rights of the Company to receive certain clinical data and other types of data from the Hospital, and obligations of the Hospital to provide such data and other support to the Company; |
C. |
The Company acknowledges that the Hospital may have provided, and will continuously be expected to provide, data and support to the Companys research and development activities at a level and frequency exceeding that anticipated in the Principal Agreements; |
D. |
The Hospital acknowledges that the Company has in all respects complied fully with the terms of the Principal Agreements; |
E. |
In consideration of the Hospitals continuous and uninterrupted support of the Companys research and development activities, the Company will pay an additional fee to the Hospital contingent upon completion of an exit in respect of the Company and payable as if the Hospital had been a warrant holder of the Company; |
F. |
On 17 July 2020, the Parties entered into a memorandum of understanding confirming the Parties intentions to enter into a definitive agreement with respect to such additional consideration and setting forth the principal terms of such definitive agreement; |
NOW, THEREFORE, the Parties hereby agree as follows:
1 |
Undertaking to Support the Company |
Subject to the terms and conditions of this Agreement, the Hospital undertakes to continue providing scientific and other relevant support to the Companys research and development activities related to the Melanoma Trial and any other cofinanced or commissioned research collaboration between the Parties under the Principal Agreements as and when reasonably required by the Company in accordance with past practice (it being noted, for the avoidance of doubt and without prejudice to any other obligation of the Hospital pursuant to any other agreement, that the Hospital will not be required to provide support to the Company pursuant to this Section 1 in respect of any particular collaboration after termination or expiry, as the case may be, of the specific agreement(s) governing such collaboration or the related funding or cofunding provided by the Company to the Hospital thereunder). Such support will be delivered by the Hospital (i) during normal working hours and at normal business days, and (ii) as soon as reasonably practicable, provided, however, that the support cannot be required to be delivered within less than two (2) business days.
2 |
Exit Payment |
2.1 |
Subject to Section 2.3, the Company shall pay a fee in the amount of DKK 5,000,000 (the Fee) to the Hospital to be paid in cash in accordance with Section 3. |
Page: 3 of 8
2.2 |
The Fee shall be in addition to any consideration paid or payable by the Company to the Hospital pursuant to the Principal Agreements. |
2.3 |
The Companys obligation to pay the Fee to the Hospital is in all respects conditional upon: |
(i) |
completion of an Exit (as defined below) in respect the Company; and |
(ii) |
the Hospitals consistent compliance with Section 1 until completion or termination (as the case may be) of the Melanoma Trial and other collaborations between the Parties under the Principal Agreements. |
2.4 |
In this Agreement, Exit means an event whereby all or substantially all of the value of the Company is realized in consideration for cash, which event may occur in a variety of ways, including, but not limited to: |
(i) |
an initial public offering (IPO) of the Companys shares; |
(ii) |
a sale of the majority of the shares and/or voting rights of the Company to a bona fide third party acquirer, including the granting of an option to so acquire the majority of the shares and/or voting rights of the Company; |
(iii) |
a sale of all or substantially all of the Companys assets to a bona fide third party acquirer, including a sale of all or substantially all of the Companys intellectual property rights, and further including the granting of an option to so acquire all or substantially all of the Companys assets; |
(iv) |
a merger whereby the Company is the discontinuing entity; |
(v) |
licensing of all or substantially all of the intellectual property rights of the Company in a way, which can be considered equal to an Exit; or |
(vi) |
a combination of any of the above, |
in each case provided that the event results in payment of cash proceeds (which are not insubstantial under the specific circumstances) to the Companys shareholders.
2.5 |
The Hospital acknowledges and agrees that the consideration paid or payable under the Principal Agreements together with the Fee shall, in all respects, be deemed full and adequate consideration for any and all rights conferred upon the Company, and any and all obligations undertaken by the Hospital, pursuant to the Principal Agreements and this Agreement. Consequently, the Hospital acknowledges and agrees that it will not be entitled to any further consideration in relation to the Principal Agreements or this Agreement. |
Page: 4 of 8
3 |
Payment Terms |
3.1 |
The Fee shall to the widest extent possible become payable to the Hospital as if the Hospital had been a holder of warrants in the Company and the Fee constituted the consideration payable for any warrants so held in connection with an Exit. For the avoidance of doubt, the foregoing means that payment of the Fee will in all respects be subject to redemption in full of any liquidation preference as per the Companys articles of association. Accordingly, if, for example, the warrant holders of the Company in connection with an Exit will be entitled or required to sell 20% of their warrants or shares subscribed on the basis of warrants, 20% of the Fee will be payable to the Hospital at completion of such Exit and the remaining 80% of the Fee (or any part thereof) will become payable at such later time when the warrant holders will be entitled or required to sell their remaining warrants or any part thereof. Further, if any part of the consideration receivable by the warrant holders in connection with an Exit is contin- gent upon future events (in the form of, for example, earn-out payments, milestone payments, option exercise payments or similar contingent payments), payment of an equivalent part of the Fee shall also be contingent upon such events on equal terms with the warrant holders. |
3.2 |
In the event of an Exit occurring in respect of the Company which results in the payment of cash proceeds to the Companys shareholders (it being specified, for the avoidance of doubt, that any event listed in Section 2.4 shall not be considered as the occurrence of an Exit for the purposes of this Section 3.2 unless and until such event results in the payment of proceeds to the Companys shareholders), the Company shall, subject to Sections 2.3 and 3.1, at or immediately following completion of such Exit pay the Fee, or the relevant part thereof, to a bank account designated by the Hospital. |
3.3 |
The Company may at any time, in its sole discretion, pay the Fee in full and final settlement of any and all obligations of the Company pursuant to this Agreement. |
3.4 |
Notwithstanding payment of the Fee, in whole or in part, whether as a result of an Exit or at the discretion of the Company, the Hospitals undertaking in Section 1 shall remain in full force and effect. |
4 |
The Hospitals application of the Fee |
4.1 |
The Hospital shall properly allocate the Fee in full to the National Center for Cancer Immune Therapy (CCIT-DK) at the Hospital (CCIT) and ensure that the Fee is solely applied for the furthering of CCITs research and development activities, without any deductions for general administrative costs of the Hospital or otherwise. |
4.2 |
Any failure by the Hospital to comply with Section 4.1 shall be deemed a material breach of this Agreement and entitle the Company to demand repayment of the part of the Fee not so properly allocated and applied. |
5 |
Confidentiality |
5.1 |
The contents of this Agreement as well as any information regarding a Party relating to the subject matter hereof shall be deemed confidential information and be subject, mutatis mutandis, to the confidentiality provisions contained in the Principal Agreements. |
6 |
Term and Termination |
6.1 |
This Agreement shall come into force and be legally binding upon the Parties at the time of the execution hereof by duly authorized representatives of each Party. |
Page: 5 of 8
6.2 |
In case of any material failure by the Company to timely pay the Fee in accordance with Section 3, the Hospital may provide written notice to the Company requesting payment within no less than ten (10) business days, failing which the Hospital may terminate the Agreement with immediate effect by giving written notice to the Company. |
6.3 |
In the event that the Hospital is in breach of this Agreement or any of the Principal Agreements, the Company may terminate the Agreement with immediate effect by giving written notice to the Hospital, provided, however, that the Hospital does not rem- edy any such breach (if capable of remedy) no later than two (2) days after the Company requesting the Hospital to remedy the breach. |
6.4 |
If no Exit has occurred in respect of the Company no later than the date falling ten (10) years after the date hereof, this Agreement shall terminate automatically with effect as of that date without further action on the part of any of the Parties. |
6.5 |
Upon termination hereof in accordance with this Section 6, neither Party shall have any right or obligation as against the other Party pursuant to or arising out of this Agreement. |
7 |
Miscellaneous |
7.1 |
This Agreement constitutes the entire agreement between the Parties and supersedes any and all prior or contemporaneous understandings and agreements, whether oral or written, between the Parties with respect to the subject matter hereof. This Agreement can only be modified by a written amendment signed by both Parties. |
7.2 |
This Agreement is not intended to amend, modify or vary any of the Principal Agreements. However, if any of the provisions of this Agreement are inconsistent with or in conflict with any of the provisions of the Principal Agreements then, to the extent of any such inconsistency or conflict, the provisions of this Agreement shall prevail. |
7.3 |
Neither Party shall be entitled to assign any of its rights and/or obligations under this Agreement, except that the Company may assign all rights and obligations hereunder in connection with a transfer of all or substantially all of the Companys assets. |
7.4 |
In the event that a provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, such provision shall be modified, rewritten or interpreted so as to include as much of its nature and scope as will render it enforceable. If it cannot be so modified, rewritten or interpreted so as to be enforceable in any respect, it shall not be given effect, and the remainder of this Agreement shall be enforced as if such provision was not included. |
7.5 |
Any failure by either Party to enforce the other Partys strict performance of any provision of this Agreement shall not constitute a waiver of the former Partys right to subsequently enforce such provision or any other provision of this Agreement. |
7.6 |
Any notices required or permitted to be given under this Agreement shall be given in writing by electronic mail (email). Such notices shall be deemed delivered on the date upon which the email was sent. Notices shall be sent to the following addresses or to such other addresses as may be designated from time to time by either Party: |
Page:6 of 8
(a) |
If to the Company: |
IO |
Biotech ApS |
[***]
(b) |
If to the Hospital: |
Herlev og Gentofte Hospital
[***]
7.7 |
For the avoidance of doubt, any tax consequences for the Hospital arising out of this Agreement, including in relation to payment of the Fee, is of no concern to the Company and shall under no circumstances impose any liability on the Company. Consequently, the Hospital carries the full liability for any tax implications for the Hospital relating to this Agreement. |
8 |
Governing Law and Venue |
8.1 |
This Agreement shall be governed by, construed and enforced in accordance with the laws of Denmark, excluding however Danish choice of law rules to the extent that such rules would otherwise lead to the application of any other law than Danish law. |
8.2 |
In the event of any dispute between the Parties related to this Agreement, including but not limited to the existence, validity, interpretation, and/or performance of any provision of this Agreement, the Parties shall seek to settle the dispute by negotiations in good faith with an aim to resolve the dispute. Such negotiations shall be commenced by a Party submitting a written request to the other Party requesting such negotiations to commence. |
8.3 |
In the event that such negotiations do not lead to a settlement of the dispute within four (4) weeks from the commencement thereof, and only then, the Parties submit to the exclusive jurisdiction of the city court of Copenhagen in the first instance to resolve any dispute between them. Any decision made or verdict rendered by such court shall be subject to appeal in accordance with applicable law. |
o0O0o
[Signatures on the following page]
Page: 7 of 8
For and on behalf of IO Biotech ApS:
/s/ Mai-Britt Zocca | /s/ Claus Andersson | |||
Mai-Britt Zocca | Claus Andersson | |||
CEO | Member of the Board of Directors |
For and on behalf of Herlev og Gentofte Hospital and CCIT-DK:
/s/ Steen Werner Hansen | /s/ Inge Marie Svane | |||
Name: Steen Werner Hansen | Name: Inge Marie Svane | |||
Title: Deputy Director | Title: Director, CCIT-DK |
[Signature page Agreement on Payment for Specific Services]
Page: 8 of 8
Exhibit 10.12
*Portions of this exhibit have been excluded because it both (i) is not material and (ii)
would be competitively harmful if publicly disclosed.
CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
by and among
MSD International GmbH,
MSD International Business GmbH,
and
IO Biotech ApS
TABLE OF CONTENTS
Page | ||||||||
1. | Definitions | 1 | ||||||
2. | Scope of the Agreement | 9 | ||||||
2.1 | Generally | 9 | ||||||
2.2 | Manufacturing Delay | 9 | ||||||
2.3 | Compound Commitments | 9 | ||||||
2.4 | Delegation of Obligations | 10 | ||||||
2.5 | Compounds | 10 | ||||||
3. | Conduct of the Study | 10 | ||||||
3.1 | Sponsor | 10 | ||||||
3.2 | Performance | 10 | ||||||
3.3 | Debarred Personnel; Exclusions Lists | 10 | ||||||
3.4 | Regulatory Matters | 10 | ||||||
3.5 | Documentation | 11 | ||||||
3.6 | Copies and Data Protection | 11 | ||||||
3.7 | Sample Testing | 11 | ||||||
3.8 | Ownership and Use of Clinical Data | 11 | ||||||
3.9 | Joint Development Committee; Alliance Managers | 12 | ||||||
3.10 | Interim Analysis | 13 | ||||||
3.11 | Final Analysis | 13 | ||||||
3.12 | Regulatory Agreement | 13 | ||||||
3.13 | Relationship | 13 | ||||||
3.14 | Licensing | 14 | ||||||
4. | Protocol, Statistical Analysis Plan and Informed Consent; Certain Covenants | 14 | ||||||
4.1 | Protocol and Statistical Analysis Plan | 14 | ||||||
4.2 | Informed Consent | 14 | ||||||
4.3 | Financial Disclosure | 14 | ||||||
4.4 | Transparency Reporting | 15 | ||||||
5. | Adverse Event Reporting | 15 | ||||||
5.1 | Pharmacovigilance Agreement | 15 | ||||||
5.2 | Transmission of SAEs | 16 | ||||||
6. | Term and Termination | 16 | ||||||
6.1 | Term | 16 | ||||||
6.2 | Termination for Material Breach | 16 | ||||||
6.3 | Termination for Patient Safety | 16 | ||||||
6.4 | Termination for Regulatory Action; Other Reasons | 17 | ||||||
6.5 | Termination Related to Anti-Corruption Obligations | 17 | ||||||
6.6 | Return of MSD Compound | 17 | ||||||
6.7 | Survival | 17 | ||||||
6.8 | No Prejudice | 17 | ||||||
6.9 | Confidential Information | 17 | ||||||
6.10 | Manufacturing Costs | 18 |
Confidential
7. | Costs of Study | 18 | ||||||||||
8. | Supply and Use of the Compounds | 18 | ||||||||||
8.1 | Supply of the Compounds |
|
18 | |||||||||
8.2 | Clinical Quality Agreement |
|
18 | |||||||||
8.3 | Minimum Shelf Life Requirements |
|
18 | |||||||||
8.4 | Provision of Compounds |
|
18 | |||||||||
8.5 | Labeling and Packaging; Use, Handling and Storage |
|
19 | |||||||||
8.6 | Product Specifications |
|
19 | |||||||||
8.7 | Changes to Manufacturing |
|
19 | |||||||||
8.8 | Product Testing; Noncompliance |
|
20 | |||||||||
8.9 | Investigations |
|
21 | |||||||||
8.10 | Shortage; Allocation |
|
21 | |||||||||
8.11 | Records; Audit Rights |
|
21 | |||||||||
8.12 | Quality |
|
21 | |||||||||
8.13 | Quality Control |
|
21 | |||||||||
8.14 | Audits and Inspections |
|
21 | |||||||||
8.15 |
Recalls VAT |
|
21 | |||||||||
8.16 | 22 | |||||||||||
9. | Confidentiality | 22 | ||||||||||
9.1 | Confidential Information |
|
22 | |||||||||
9.2 | Inventions |
|
23 | |||||||||
9.3 | Personal Identifiable Data |
|
23 | |||||||||
10. | Intellectual Property | 23 | ||||||||||
10.1 | Joint Ownership and Prosecution |
|
23 | |||||||||
10.2 | Inventions Owned by Company |
|
24 | |||||||||
10.3 | Inventions Owned by MSD |
|
24 | |||||||||
10.4 | Mutual Freedom to Operate for Combination Inventions |
|
24 | |||||||||
10.5 | Right of First Negotiation |
|
24 | |||||||||
11. | Reprints; References in Publication | 25 | ||||||||||
12. | Publications; Press Releases | 25 | ||||||||||
12.1 | Clinical Trial Registry |
|
25 | |||||||||
12.2 | Publication |
|
25 | |||||||||
12.3 | Press Releases |
|
26 | |||||||||
13. | Representations and Warranties; Disclaimers | 26 | ||||||||||
13.1 | Due Authorization |
|
26 | |||||||||
13.2 | Compounds |
|
26 | |||||||||
13.3 | Results | 26 | ||||||||||
13.4 | Anti-Corruption |
|
27 | |||||||||
13.5 | DISCLAIMER |
|
28 |
ii
Confidential
14. | Insurance; Indemnification; Limitation of Liability | 29 | ||||||
14.1 | Insurance | 29 | ||||||
14.2 | Indemnification | 29 | ||||||
14.3 | LIMITATION OF LIABILITY | 29 | ||||||
15. | Use of Name | 30 | ||||||
16. | Force Majeure | 30 | ||||||
17. | Entire Agreement; Amendment; Waiver | 30 | ||||||
18. | Assignment and Affiliates | 31 | ||||||
19. | Change of Control | 31 | ||||||
20. | Invalid Provision | 31 | ||||||
21. | No Additional Obligations | 32 | ||||||
22. | Governing Law; Dispute Resolution | 32 | ||||||
23. | Notices | 33 | ||||||
24. | Relationship of the Parties | 33 | ||||||
25. | Counterparts and Due Execution | 33 | ||||||
26. | Construction | 34 |
Appendices
Appendix A Protocol
Appendix B Supply of Compound
Appendix C Data Protection Terms
Appendix D Form of Press Release
Schedules
Schedule I Data Sharing Schedule
Schedule II Sample Testing Schedule
iii
Confidential
CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (this Agreement), is entered into as of the date of last signature hereunder (the Effective Date), by and among MSD International GmbH (MSDIG), MSD International Business GmbH (MSDIB and collectively with MSDIG, MSD), having a place of business at [***] and IO Biotech ApS, having a place of business at [***] (Company). MSD and Company are each referred to herein individually as Party and collectively as Parties.
RECITALS
A. |
MSD and/or its Affiliates holds intellectual property rights with respect to the MSD Compound (as defined below). |
B. |
Company is developing the Company Compounds (as defined below) for the treatment of certain tumor types. |
C. |
MSD and/or its Affiliates is developing the MSD Compound for the treatment of certain tumor types. |
D. |
Company desires to sponsor a clinical trial in which the Company Compounds and the MSD Compound would be dosed concurrently or in combination. |
E. |
MSD and Company, consistent with the terms of this Agreement, desire to collaborate as more fully described herein, including by providing the MSD Compound and the Company Compounds for the Study (as defined below). |
NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions, the Parties, intending to be legally bound, mutually agree as follows:
1. |
Definitions. |
For all purposes of this Agreement, the capitalized terms defined in this Article 1 and throughout this Agreement shall have the meanings herein specified.
1.1 Affiliate means, with respect to either Party, a person, firm, corporation, partnership or other entity that, now or hereafter, directly or indirectly owns or controls said Party, or, now or hereafter, is owned or controlled by said Party, or is under common ownership or control with said Party. The word control as used in this definition means (a) the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of a legal entity or (b) possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities, contract rights, voting rights, corporate governance or otherwise.
1.2 Agreement means this agreement, as amended by the Parties from time to time, and as set forth in the preamble.
Confidential
1.3 Alliance Manager has the meaning set forth in Section 3.9.3.
1.4 Applicable Law means all federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, including performance of clinical trials, medical treatment and the processing and protection of personal and medical data, that may be in effect from time to time, including those promulgated by the United States Food and Drug Administration (FDA), national regulatory authorities, the European Medicines Agency (EMA) and any successor agency to the FDA or EMA or any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union (each a Regulatory Authority and collectively, Regulatory Authorities), and including cGMP and GCP (each as defined below); Data Protection Laws; export control and economic sanctions regulations which prohibit the shipment of United States-origin products and technology to certain restricted countries, entities and individuals; anti-bribery and anti-corruption laws pertaining to interactions with government agents, officials and representatives; laws and regulations governing payments to healthcare providers; and any United States or other countrys or jurisdictions successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing.
1.5 Business Day means any day other than a Saturday, Sunday, or a day on which commercial banks located in the country where the applicable obligations are to be performed are authorized or required by law to be closed.
1.6 cGMP means the current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the Manufacture of the Compounds.
1.7 Change of Control means, with respect to the Company, and except for any change resulting solely from change in the legal domicile of the Company and/or its Affiliates (e.g. from ApS to US C-Corp entity) , (a) the sale of all or substantially all of the assets or business relating to this Agreement; or (b) a merger, reorganization or consolidation involving the Company in which the voting securities immediately prior thereto cease to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation; (c) any Third Party (or group of Third Parties acting in concert) becoming the beneficial owner directly or indirectly, of fifty percent (50%) or more of the total voting power of the Company; or (d) the acquisition by a Third Party of the right to nominate a majority of the members of the board of directors (or similar governing body), or to otherwise control the affairs of the Company.
1.8 Clinical Data means all data (including raw data) and results generated by or on behalf of either Party or at either Partys direction, or by or on behalf of the Parties together or at their direction, in the course of each such Partys performance of the Study, [***]. For clarity, Clinical Data shall include Personal Data collected for the Study which is necessary or useful by a Party: (a) for the interpretation or analysis of Study results; (b) for the development of Compounds in accordance with this Agreement; (c) for any submission or response to a Regulatory Authority; (d) to comply with Applicable Law; or (e) to conduct any activities in accordance with this Agreement.
2
Confidential
1.9 [***]
1.10 Clinical Quality Agreement has the meaning set forth in Section 8.2.
1.11 CMC means Chemistry Manufacturing and Controls as such term of art is used in the pharmaceutical industry.
1.12 Combination means the use or method of using both Company Compounds and the MSD Compound [***].
1.13 Combination Data has the meaning set forth in Section 3.8.1.
1.14 Company has the meaning set forth in the preamble.
1.15 Company Background Patents has the meaning set forth in Section 10.4.1.
1.16 Company Class Compound means [***].
1.17 Company Compounds means the compounds designated as IO102 and IO103 respectively, [***]. A Company Compound means either IO102 or IO103, as applicable.
1.18 Company Inventions has the meaning set forth in Section 10.2.
1.19 Compounds means the Company Compounds and the MSD Compound. A Compound means either of the Company Compounds or the MSD Compound, as applicable.
1.20 Confidential Information means any information, Know-How or other proprietary information or materials furnished to one Party (Receiving Party) by or on behalf of the other Party (Disclosing Party) in connection with this Agreement, including all Personal Data subject to Data Protection Laws, except to the extent that such information or materials: (a) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party, [***]; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; (d) was disclosed to the Receiving Party by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or (e) was subsequently developed by the Receiving Party without use of the Disclosing Party Confidential Information, [***].
1.21 Continuing Party has the meaning set forth in Section 10.1.3.
1.22 Control or Controlled means, with respect to particular information or intellectual property, that the applicable Party owns or has a license to such information or intellectual property and has the ability to grant a right, license or sublicense to the other Party as provided for herein [***].
1.23 CTA means an application to a Regulatory Authority for purposes of requesting the ability to start or continue a clinical trial.
3
Confidential
1.24 Data Protection Terms means Appendix C hereto, which ensures certain protections are in place for the processing personal data in the performance of the Study and sets forth the Parties responsibilities for certain obligations, including addressing the rights of data subjects, ensuring a legal basis for processing personal data, conducting appropriate data-protection impact assessments and prior consultations with relevant supervisory authorities, complying with all personal-data breach-notification obligations, and certain other compliance obligations under Data Protection Law.
1.25 Data Protection Law has the meaning set forth in the Data Protection Terms.
1.26 Data Sharing Schedule means the schedule attached hereto as Schedule I.
1.27 Defending Party has the meaning set forth in Section 14.2.3.
1.28 Delivery with respect to the MSD Compound has the meaning set forth in Section 8.4.1, and with respect to the Company Compounds, the meaning set forth in Section 8.4.2.
1.29 [***]
1.30 Disclosing Party has the meaning set forth in the definition of Confidential Information.
1.31 Disposition Package has the meaning set forth in Section 8.8.1.
1.32 Effective Date has the meaning set forth in the preamble.
1.33 EMA has the meaning set forth in the definition of Applicable Law.
1.34 Exclusions List has the meaning set forth in the definition of Violation.
1.35 FDA has the meaning set forth in the definition of Applicable Law.
1.36 Filing Party has the meaning set forth in Section 10.1.3.
1.37 Final Analysis has the meaning set forth in Section 3.11.
1.38 First Party has the meaning set forth in Section 8.16.2.
1.39 Force Majeure has the meaning set forth Article 16.
1.40 GAAP has the meaning set forth in Section 6.10.
1.41 GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds.
4
Confidential
1.42 Government Official means: (a) any officer or employee of a government or any department, agency or instrument of a government; (b) any Person acting in an official capacity for or on behalf of a government or any department, agency, or instrument of a government; (c) any officer or employee of a company or business owned in whole or part by a government; (d) any officer or employee of a public international organization such as the World Bank or United Nations; (e) any officer or employee of a political party or any Person acting in an official capacity on behalf of a political party; and/or (f) any candidate for political office; who, when such Government Official is acting in an official capacity, or in an official decision-making role, has responsibility for performing regulatory inspections, government authorizations or licenses, or otherwise has the capacity to make decisions with the potential to affect the business of either of the Parties.
1.43 IND means any Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an Investigational Medicinal Product Dossier filed or to be filed with Regulatory Authorities in the European Union.
1.44 [***]
1.45 Interim Analysis has the meaning set forth in Section 3.10.
1.46 Inventions means all inventions and discoveries, whether or not patentable, that are made, conceived, or first actually reduced to practice by or on behalf of a Party, or by or on behalf of the Parties together, [***].
1.47 Joint Development Committee or JDC has the meaning set forth in Section 3.9.1.
1.48 Joint Patent Application has the meaning set forth in Section 10.1.3.
1.49 Joint Patent means a patent, extension, registration, supplementary protection certificate or the like that issues from a Joint Patent Application.
1.50 Jointly Owned Invention has the meaning set forth in Section 10.1.1.
1.51 Know-How means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain.
1.52 Liability has the meaning set forth in Section 14.2.1.
1.53 Manufacture, Manufactured, or Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.
5
Confidential
1.54 Manufacturers Release or Release has the meaning ascribed to such term in the Clinical Quality Agreement.
1.55 Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.
1.56 MSD has the meaning set forth in the preamble.
1.57 MSD Background Patents has the meaning set forth in Section 10.4.2.
1.58 MSD Compound means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody, [***].
1.59 MSDIB has the meaning set forth in the preamble.
1.60 MSDIG has the meaning set forth in the preamble.
1.61 MSD Inventions has the meaning set forth in Section 10.3.
1.62 MSD Right has the meaning set forth in Section 10.5.2.
1.63 NDA means a New Drug Application, Biologics License Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.
1.64 Negotiation Period has the meaning set forth in Section 10.5.2.
1.65 Non-Conformance means, with respect to a given unit of Compound, (a) an event that deviates from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or that requires an investigation to assess impact to the quality of the applicable Compound or (b) that such Compound failed to meet the applicable representations and warranties set forth in Section 2.3. Classification of the Non-Conformance is detailed in the Clinical Quality Agreement.
1.66 Non-Filing Party has the meaning set forth in Section 10.1.3.
1.67 Opting-out Party has the meaning set forth in Section 10.1.3.
1.68 Other Party has the meaning set forth in Section 14.2.3.
1.69 Party or Parties has the meaning set forth in the preamble.
1.70 PD-1 Antagonist means any [***].
1.71 Pembro-Only Arm shall mean the arm of the Study involving the MSD Compound only and not the Company Compounds.
6
Confidential
1.72 Pembro-Only Arm Data shall mean all data (including raw data) generated under the Pembro-Only Arm.
1.73 Person means any individual, sole proprietorship, partnership, corporation, business trust, joint stock company, trust, unincorporated organization, association, limited liability company, institution, public benefit corporation, joint venture, entity or governmental entity.
1.74 Personal Data has the meaning set forth for personal data in the European Commission Decision 2004/915/EC, as amended.
1.75 Pharmacovigilance Agreement has the meaning set forth in Section 5.1.
1.76 Prior CDA has the meaning set forth in Article 17.
1.77 Project Manager has the meaning set forth in Section 3.9.1.
1.78 Protocol means the written documentation set forth in Appendix A that describes the Study and sets forth specific activities to be performed as part of the conduct of the Study.
1.79 Receiving Party has the meaning set forth in the definition of Confidential Information.
1.80 Regulatory Agreement means that certain regulatory agreement regarding the Compounds to be entered into by the Parties pursuant to Section 3.12, as the same may be amended from time to time.
1.81 Regulatory Approvals means, with respect to a Compound, any and all permissions (other than the Manufacturing approvals) required to be obtained from Regulatory Authorities and any other competent authority for the development, registration, importation, use, distribution, sale and marketing of such Compound in the United States, Europe or other applicable jurisdictions, including any pricing or reimbursement approvals.
1.82 Regulatory Authority or Regulatory Authorities has the meaning set forth in the definition of Applicable Law.
1.83 Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, CTAs, NDAs and amendments thereto, drug master files including CMC data, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case, together with all supporting documents (including documents that include Clinical Data).
1.84 Related Agreements means the Pharmacovigilance Agreement, the Clinical Quality Agreement, and the Regulatory Agreement.
7
Confidential
1.85 Right of Reference means the right of reference defined in 21 CFR 314.3(b), including with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Documentation (and any data contained therein) filed with such Regulatory Authority with respect to a Partys Compound(s), only to the extent necessary for the other Party to conduct the Study in such country or as otherwise expressly permitted or required under this Agreement to enable the other Party to exercise its rights or perform its obligations hereunder.
1.86 ROFN Period has the meaning set forth in Section 10.5.1.
1.87 ROFN Transaction has the meaning set forth in Section 10.5.1.
1.88 SAEs has the meaning set forth in Section 5.2.
1.89 Samples means biological specimens collected from subjects participating in the Study, including urine, blood and tissue samples.
1.90 Sample Testing means the analyses to be performed by each Party using the applicable Samples, as described in the Sample Testing Schedule.
1.91 Sample Testing Results means those data and results arising from the Sample Testing performed by a Party.
1.92 Sample Testing Schedule means the schedule attached hereto as Schedule II.
1.93 Second Party has the meaning set forth in Section 8.16.2.
1.94 Sensitive Information means unpublished Pembro-Only Arm Data, Sample Testing Results generated by MSD and Confidential Information relating to MSD Inventions or the MSD Compound (but not information solely relating to a Company Compound and not to the MSD Compound).
1.95 Special Categories of Data has the meaning set forth for special categories of data in the European Commission Decision 2004/915/EC, as amended.
1.96 Specifications means, with respect to a given Compound, the set of requirements for such Compound as set forth in the Clinical Quality Agreement.
1.97 Study means the study titled Randomized Phase II/III trial of IO102-IO103 plus pembrolizumab versus pembrolizumab in anti PD-1 naïve advanced melanoma as described in the Protocol.
1.98 Study Completion has the meaning set forth in Section 3.11.
1.99 Subcontractors has the meaning set forth in Section 2.4.
1.100 Term has the meaning set forth in Section 6.1.
1.101 Third Party means any Person or entity other than Company, MSD or their respective Affiliates.
8
Confidential
1.102 Toxicity and Safety Data means all clinical adverse event information and/or patient-related safety data [***]
1.103 Transparency Report has the meaning set forth in Section 4.4.
1.104 Unsolicited Offer has the meaning set forth in Section 10.5.1.
1.105 VAT has the meaning set forth in Section 8.16.
1.106 Violation means that a Party or any of its officers or directors or any other personnel (or other permitted agents of a Party performing activities hereunder) has been: (a) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/exclusions/authorities.asp); (b) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (http://exclusions.oig.hhs.gov/) or listed as having an active exclusion in the System for Award Management (http://www.sam.gov); or (c) listed by any US Federal agency as being suspended, proposed for debarment, debarred, excluded or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (http://www.fda.gov/ora/compliance_ref/debar/) ((a), (b) and (c) collectively the Exclusions Lists).
2. |
Scope of the Agreement. |
2.1 Generally. Each Party shall: (a) contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party.
2.2 Manufacturing Delay. Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound(s) as contemplated by this Agreement.
2.3 Compound Commitments.
2.3.1 Company agrees to Manufacture and supply the Company Compounds for purposes of the Study in accordance with Article 8, and Company hereby represents and warrants to MSD that, at the time of Delivery of the Company Compounds, such Company Compounds shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Company Compounds; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections.
2.3.2 MSD and/or its Affiliate(s) agrees to Manufacture and supply the MSD Compound for purposes of the Study in accordance with Article 8, and MSD and/or its Affiliate(s) hereby represents and warrants to Company that, at the time of Delivery of the MSD Compound, such MSD Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the MSD Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections.
9
Confidential
2.3.3 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound(s) in accordance with Applicable Law (provided that, for clarity, Company shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4).
2.4 Delegation of Obligations. Each Party shall have the right to delegate any portion of its obligations hereunder as follows: (a) to such Partys Affiliates; (b) to Third Parties that are set forth on Schedule 2.4 or are set forth in the Protocol as performing Study activities or as conducting Sample Testing for such Party; (c) to Third Parties solely in connection with the Manufacture of such Partys Compound(s); and (d) upon the other Partys prior written consent. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as Subcontractors. Notwithstanding any delegation of its obligations hereunder, each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. Each Party shall ensure that each of its Affiliates and Subcontractors performs such Partys obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates and Subcontractors that are required to be provided to the other Party under this Agreement.
2.5 Compounds. This Agreement does not create any obligation on the part of MSD and/or its Affiliate(s) to provide the MSD Compound for any activities other than the Study, nor does it create any obligation on the part of Company to provide the Company Compounds for any activities other than the Study.
3. |
Conduct of the Study. |
3.1 Sponsor. Company shall act as the sponsor of the Study under an approved IND or CTA for the Company Compounds with a Right of Reference to the IND or CTA of the MSD Compound, as necessary, as further described in Section 3.4; provided, however, that in no event shall Company file an additional IND or CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests an additional IND or CTA for the Study, the Parties shall meet and mutually agree on an approach to address such requirement.
3.2 Performance. Company shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP.
3.3 Debarred Personnel; Exclusions Lists. [***]
3.4 Regulatory Matters. Company shall: (a) obtain, prior to initiating the Study, all Regulatory Approvals from all Regulatory Authorities, ethics committees and/or institutional review boards with jurisdiction over the Study prior to initiating the Study; and (b) follow all directions from any such Regulatory Authorities, ethics committees and/or institutional review boards. MSD [***] with a Regulatory Authority regarding matters related to the MSD Compound. MSD shall authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate MSD Compound INDs and CTAs to provide data access and a Right of Reference to Company solely to the extent needed to enable Company to fulfil its obligations in connection with
10
Confidential
Companys conduct of the Study. If MSDs CTA is not available in a given country, [***]. If a Right of Reference to Companys INDs or CTAs for the Company Compounds is necessary for MSD to fulfill its obligations in connection with the conduct of the Study, Company shall provide a cross-reference letter or similar communication to the applicable Regulatory Authority if needed to effectuate the Right of Reference solely to the extent needed to enable MSD to fulfill its obligations in connection with the conduct of the Study. [***]
3.5 Documentation . Company shall maintain reports and all related documentation in good scientific manner and in compliance with Applicable Law. Company shall provide to MSD all Study information and documentation reasonably requested by MSD to enable MSD to (a) comply with any of its legal, regulatory and/or Third Party contractual obligations, or any request by any Regulatory Authority, related to the MSD Compound and (b) determine whether the Study has been performed in accordance with this Agreement.
3.6 Copies and Data Protection . Company shall provide to MSD copies of all Clinical Data, in electronic form or other mutually agreeable alternate form on the timelines specified in the Data Sharing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that a complete copy of the Clinical Data shall be provided to MSD no later than [***] following Study Completion. Company shall ensure that all patient authorizations and consents required under Data Protection Laws in connection with the Study permit such sharing of Clinical Data with MSD, and each Party shall ensure that it complies with Applicable Law in transferring personal data in connection with sharing the Clinical Data. The Parties will comply with the Data Protection Terms set forth in Appendix C, which are incorporated into and form a part of this Agreement. In the event of any inconsistencies between the Data Protection Terms and the other terms of this Agreement, the Data Protection Terms will control as set forth in the Data Protection Terms.
3.7 Sample Testing .
3.7.1 Company shall provide Samples to MSD as specified in the Protocol or as agreed to by the Joint Development Committee. Each Party shall (a) use the Samples only for the Sample Testing and (b) conduct the Sample Testing solely in accordance with the Sample Testing Schedule and the Protocol.
3.7.2 [***]
3.7.3 [***]
3.7.4 Except to the extent otherwise agreed in a writing signed by authorized representatives of each Party, each Party may use and disclose the Sample Testing Results owned by the other Party and shared by such other Party in accordance with the Sample Testing Schedule [***].
3.8 Ownership and Use of Clinical Data .
3.8.1 All Clinical Data other than Pembro Only Arm Data (the Combination Data) shall be jointly owned by Company and MSD. [***] Company shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, Company shall grant MSD access to all Clinical Data for uses permitted in this Agreement. [***].
11
Confidential
3.8.2 Notwithstanding the foregoing Section 3.8.1, before publication of the Combination Data in accordance with Article 12: [***]; provided, however, that the foregoing shall not limit or restrict either Partys ability to [***]. If a Party believes disclosure of Clinical Data is necessary to comply with Applicable Law or rules of a securities exchange, such Party shall promptly inform the other Party of the disclosure that is being sought, and consult and cooperate fully with the other Party in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Any information disclosed shall remain otherwise subject to the confidentiality and non-use provisions of this Section, and the Party disclosing such information shall take all steps reasonably necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such information.
3.8.3 Notwithstanding anything to the contrary in this Section 3.8, unpublished Clinical Data from the Study may be used [***]. If MSD desires to update its label for the MSD Compound to add an indication involving administration of the MSD Compound in a Combination or if Company desires to seek Regulatory Approval of a Company Compound for an indication involving administration of the Company Compound in a Combination, in each case, based on the results of the Study, such Party shall notify the other Party at least [***] prior to submitting any Regulatory Documentation to initiate such label change or obtain such Regulatory Approval. [***]
3.8.4 Notwithstanding anything to the contrary in this Section 3.8, Company may: [***]; and (iii) Company must notify MSD at least [***] before such disclosure of the reasons for the planned disclosure [***] before such disclosure of the reasons for the planned disclosure and provide MSD with a copy of the Combination Data and topline results of the Pembro-Only Arm and any related summaries or analyses, as applicable, which are to be disclosed, and further provided that with respect to topline results of the Pembro-Only Arm only, Company shall consider in good faith and implement MSDs comments to the extent consistent with such Applicable Law, applicable securities laws and applicable rules of such securities exchange.
3.9 Joint Development Committee; Alliance Managers .
3.9.1 As soon as practicable after the Effective Date, the Parties shall form a joint development committee (the Joint Development Committee or JDC) made up of an equal number of representatives of MSD and Company, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. The JDC will review and finalize the Protocol in accordance with Section 4.1. Each Party shall designate a project manager (the Project Manager) who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties with respect to the Study and shall be a member of the JDC. Other JDC members will be agreed by both Parties.
12
Confidential
3.9.2 The JDC shall meet as soon as practicable after its formation and then no less than [***], and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, internet conference, videoconference or other similar communications equipment. Prior to any such meeting, Companys Project Manager shall provide an update in writing to MSDs Project Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study.
3.9.3 In addition to a Project Manager, each Party shall designate an alliance manager (the Alliance Manager), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement outside of the JDC. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing.
3.9.4 In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, such issue shall be submitted for resolution by the JDC. If there is a decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the [***] for MSD and the Chief Executive Officer for Company. In the event such escalation does not result in resolution or consensus: [***].
3.10 Interim Analysis . Following interim data readout at a predefined point set out in the Protocol, Company shall provide MSD with an electronic copy of the interim Study data when available, the criteria of which shall be determined by the JDC within [***] of the formation of the JDC (the Interim Analysis).
3.11 Final Analysis . Following Study Completion, Company shall provide MSD with an electronic copy of then-available final Study data, including, as applicable and set forth for final readout in the clinical study plan for the Study, data relating to safety, progression free survival, overall responses rate, durable response rate, and/or complete response rate (the Final Analysis). Study Completion [***].
3.12 Regulatory Agreement. The Parties shall enter into the Regulatory Agreement no later than [***] after the Effective Date. It is understood and acknowledged by the Parties that positive Clinical Data may be used to obtain label changes for the Compounds. In such event, the Parties will collaborate on regulatory matters in accordance with the Regulatory Agreement.
3.13 Relationship . Except as expressly set forth in this Agreement, nothing in this Agreement shall: [***] or (b) create an exclusive relationship between the Parties with respect to any Compound. Each Party acknowledges and agrees that nothing in this Agreement shall be construed as a representation or inference that the other Party will not develop for itself, or enter into business relationships with other Third Parties regarding, any products, programs, studies (including combination studies), technologies or processes that are similar to or that may compete with the Combination or any other product, program, technology or process, including [***] are not used or disclosed in connection therewith in violation of this Agreement. Notwithstanding the foregoing, or anything in this Agreement to the contrary, Company shall have no right to include any PD-1 Antagonist other than the MSD Compound in the Study.
13
Confidential
3.14 Licensing . Nothing in this Agreement shall prohibit or restrict a Party from licensing, assigning or otherwise transferring to an Affiliate or Third Party such Partys Compound(s) [***] owned solely by such Party. A Party may license, assign or transfer to an Affiliate or Third Party such Partys interest in the [***] owned jointly by the Parties and/or [***], and in connection therewith [***] owned by the other Party, solely to the extent such licensee, assignee or transferee agrees in writing to be bound by the terms of this Agreement with respect to such [***]. For purposes of clarity, any assignment or transfer of this Agreement must comply with Article 18 of this Agreement.
4. |
Protocol, Statistical Analysis Plan and Informed Consent; Certain Covenants . |
4.1 Protocol and Statistical Analysis Plan . A Protocol and the draft statistical analysis plan for the Study have been agreed to by the Parties as of the Effective Date and are attached hereto as Appendix A. Through the JDC, Company shall (a) provide any subsequent revisions of the Protocol to MSD for MSDs review and comment, (b) consider in good faith any changes to the Protocol requested by MSD, and (c) incorporate any changes requested by MSD with respect to MSD Compound. To the extent the JDC cannot agree unanimously regarding the contents of the revised Protocol for final approval the matter shall be resolved in accordance with Section 3.9.4. Once the final Protocol has been approved in accordance with this Section 4.1, any material changes to such approved final Protocol [***] shall require [***].
4.1.1 Notwithstanding anything to the contrary contained herein, [***], in its sole discretion, shall have the sole right to determine [***] and shall have the final decision on all matters relating to the [***] and any information regarding [***] included in the Protocol.
4.1.2 Notwithstanding anything to the contrary contained herein, [***] in its sole discretion, shall have the sole right to determine [***] and shall have the final decision on all matters relating to the [***] and any information regarding [***] included in the Protocol.
4.2 Informed Consent . Company shall prepare the patient informed consent form for the Study (which shall include provisions regarding the use of Samples in Sample Testing and the processing of Personal Data, including Special Categories of Data, in accordance with this Agreement, including without limitation any data protection agreement entered into by the Parties) in consultation with MSD (it being understood and agreed that the portion of the informed consent form relating to the Sample Testing of the MSD Compound shall be prepared by MSD and provided to Company by MSD). Any proposed changes to such form that relate to the MSD Compound, including Sample Testing of the MSD Compound, shall be subject to MSDs prior written consent. Any such proposed changes will be sent in writing to MSDs Project Manager and MSDs Alliance Manager. MSD will provide such consent, or a written explanation for why such consent is being withheld, within [***] after MSD receives a copy of Companys requested changes.
4.3 Financial Disclosure . Company shall [***].
14
Confidential
4.4 Transparency Reporting .
4.4.1 With respect to any annual reporting period in which Company is not an entity that is required to make a Transparency Report under Applicable Law, when requested, Company will use commercially reasonable efforts to provide to MSD data regarding payments or other transfers of value that MSD reasonably determines constitute indirect payments or other transfers of value by MSD in the format requested by MSD and provided on a basis to be agreed upon by both Parties.
4.4.2 With respect to any annual reporting period in which [***], Company will provide to MSD, in writing, Companys point of contact for purposes of receiving information from MSD pursuant to this Section 4.4, along with such contacts full name, email address, and telephone number. Company may update such contact from time to time by notifying MSD in writing pursuant to Article 23 (Notices). Where applicable, MSD will provide to Company all such contact information regarding the value of the MSD Compound provided for use in the Study required for such reporting. In the event that the value of the MSD Compound provided pursuant to this Section 4.4.2 changes, MSD shall notify Company of such revised value and the effective date thereof.
4.4.3 For purposes of this Section 4.4, Transparency Report means a transparency report in connection with reporting payments and other transfers of value made to health care professionals or facilities, including, without limitation, teaching hospitals, investigators, steering committee members, data monitoring committee members, and consultants in connection with the Study in accordance with reporting requirements under Applicable Law, including, without limitation, the Physician Payment Sunshine Act and state gift laws, and the European Federation of Pharmaceutical Industries and Associations Disclosure Code, or a Partys applicable policies to the extent such policies have been previously provided to and acknowledged in writing by the other Party.
5. |
Adverse Event Reporting . |
5.1 Pharmacovigilance Agreement . Company will be solely responsible for compliance with all Applicable Law pertaining to safety reporting for the Study and related activities. The Parties (or their respective Affiliates) will execute a pharmacovigilance agreement inclusive of safety management plan details (the Pharmacovigilance Agreement) prior to the initiation of clinical activities under the Study, but in any event within [***] after the Effective Date, to ensure the exchange of relevant safety data within appropriate timeframes and in an appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews. In the event of any inconsistency between the terms of this Agreement and the Pharmacovigilance Agreement, [***] The Pharmacovigilance Agreement will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, pregnancy reports, and any other safety information arising from or related to the use of the [***] in the Study, consistent with Applicable Law. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to Regulatory Authorities. For the avoidance of doubt, the obligations to provide safety data under the Pharmacovigilance Agreement will be independent of any obligations to provide safety data pursuant to this Agreement.
15
Confidential
5.2 Transmission of SAEs . Company will transmit to MSD all serious adverse events (SAEs) as follows:
5.2.1 For drug-related fatal and life-threatening SAEs, and newly diagnosed cancer, Company will send a processed case (on a CIOMS-1 form in English) within [***] after receipt by Company of such SAEs.
5.2.2 For all other SAEs, including non-drug-related fatal and life-threatening SAEs, Company will send a processed case (on a CIOMS-1 form in English) within [***] after receipt by Company of such SAEs.
5.2.3 Cases of disease progression will be handled as outlined in the Protocol, and if the Protocol specifies that such cases are collected as SAEs, Company will transmit such cases to MSD within the applicable timeframe set forth in Section 5.2.1 or Section 5.2.2.
5.2.4 For all other reportable information that includes: (1) overdose, exposure during pregnancy of lactation; and (ii) cases of potential drug-induced liver injury where the patient was exposed to the MSD Compound (if required to be collected or identified per the Protocol), Company will transmit a processed case within [***] after receipt by Company of such information.
6. |
Term and Termination . |
6.1 Term . The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until delivery of the Final Analysis, unless terminated earlier by either Party pursuant to this Article 6 (the Term).
6.2 Termination for Material Breach . Either Party may terminate this Agreement if the other Party commits a material breach of this Agreement, and such material breach continues for [***] after receipt of written notice thereof from the non-breaching Party; provided that if such material breach cannot reasonably be cured within [***], the breaching Party shall be given a reasonable period of time to cure such breach; provided further, that if such material breach is incapable of cure, then the notifying Party may terminate this Agreement effective after the expiration of such [***] period.
6.3 Termination for Patient Safety . If either Party determines in good faith, [***], that (a) the MSD Compound is being used in the Study in an unsafe manner or (b) performing or continuing to perform the Study may pose an unreasonable risk to patient safety, such Party shall promptly notify the other Party of such determination. The Party receiving such notice may propose modifications to the Protocol or Study to address the safety issue identified by the other Party and, if the notifying Party agrees, shall act to implement immediately such modifications; provided, however, that if the notifying Party, in its sole discretion, believes that there is imminent danger to patients, such Party need not wait for the other Party to propose modifications and may instead terminate this Agreement immediately upon written notice to such other Party. Furthermore, if the notifying Party, in its sole discretion, believes that any modifications proposed by the other Party will not resolve the patient safety issue, such Party may terminate this Agreement effective upon written notice to such other Party.
16
Confidential
6.4 Termination for Regulatory Action; Other Reasons . Either Party may terminate this Agreement immediately upon written notice to the other Party in the event that any Regulatory Authority takes any action, or raises any objection, that prevents the terminating Party from supplying its Compound(s) for purposes of the Study. Additionally, either Party shall have the right to terminate this Agreement immediately upon written notice to the other Party in the event that it determines in its sole discretion to withdraw any applicable Regulatory Approval for its Compound(s) or to discontinue development of its Compound(s) for medical, scientific or legal reasons.
6.5 Termination Related to Anti-Corruption Obligations . Either Party shall have the right to terminate this Agreement immediately upon written notice to the other Party, if such other Party fails to perform any of its obligations under Section 13.4 or breaches any representation or warranty contained in Section 13.4. Except as set forth in [***], the non-terminating Party shall have no claim against the terminating Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 6.5.
6.6 Return of MSD Compound . In the event that this Agreement is terminated, or in the event Company remains in possession (including through any Affiliate or Subcontractor) of MSD Compound at the time this Agreement expires, Company shall, at MSDs sole discretion, promptly either return or destroy all unused MSD Compound pursuant to MSDs instructions. If MSD requests that Company destroy the unused MSD Compound, Company shall provide written certification of such destruction. Notwithstanding the foregoing, in the event this Agreement is terminated by MSD pursuant to any of Sections 6.2 or 6.5 and MSD requests that all unused MSD Compound be returned, Company shall promptly return the unused MSD Compound to MSD at Companys expense.
6.7 Survival . The provisions of [***] shall survive the expiration or termination of this Agreement.
6.8 No Prejudice . Termination of this Agreement shall be without prejudice to any claim or right of action of either Party against the other Party for any prior breach of this Agreement.
6.9 Confidential Information . Upon termination of this Agreement, each Party and its Affiliates shall promptly return to the Disclosing Party [***] furnished to the Receiving Party by the Disclosing Party; provided, however that the Receiving Party may retain one (1) copy of such Confidential Information in its confidential files, solely for purposes of exercising the Receiving Partys rights hereunder, satisfying its obligations hereunder or complying with any legal proceeding or requirement with respect thereto, and provided further that the Receiving Party shall not be required to erase electronic files created in the ordinary course of business during automatic system back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information so long as such electronic files are (a) maintained only on centralized storage servers (and not on personal computers or devices), (b) not accessible by any of its personnel (other than its information technology specialists), and (c) are not otherwise accessed subsequently except with the written consent of the Disclosing Party or as required by law or legal process. Such retained copies of Confidential Information shall remain subject to the confidentiality and non-use obligations herein.
17
Confidential
6.10 Manufacturing Costs . In the event of termination by MSD pursuant to any of Sections 6.2 or 6.5 above, MSD shall be entitled to [***].
7. |
Costs of Study . |
The Parties agree that: [***].
8. |
Supply and Use of the Compounds . |
8.1 Supply of the Compounds . Subject to the terms and conditions of this Agreement, each of Company and MSD and/or its Affiliate(s) will use commercially reasonable efforts to supply, or cause to be supplied, the quantities of its respective Compound(s) as are set forth in Appendix B, on the timelines set forth in Appendix B, in each case, for use in the Study. If the Protocol is changed in accordance with Article 4 in such a manner that may affect the quantities of Compound(s) to be provided or the timing for providing such quantities, the Parties shall amend Appendix B to reflect any changes required to be consistent with the Protocol. Each Party shall also provide to the other Party a contact person for the supply of its Compound(s) under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that a Party is: (a) not supplying its Compound(s) in accordance with the terms of this Agreement, then the other Party shall have no obligation to supply its Compound(s); or (b) allocating under Section 8.10, then the other Party may allocate proportionally.
8.2 Clinical Quality Agreement . Within [***] after the Effective Date of this Agreement, but in any event before any supply of MSD Compound hereunder, the Parties (or their respective Affiliates) shall enter into a quality agreement that shall address and govern issues related to the quality and handling of clinical drug supply to be supplied by the Parties for use in the Study (the Clinical Quality Agreement). In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, [***]. The Clinical Quality Agreement shall, among other things: (a) detail classification of any Compound found to have a Non-Conformance; (b) include criteria for Manufacturers Release and related certificates and documentation; (c) include criteria and timeframes for acceptance of MSD Compound; (d) include procedures for the resolution of disputes regarding any Compounds found to have a Non-Conformance; and (e) include provisions governing the recall of Compounds.
8.3 Minimum Shelf Life Requirements . Each Party shall use commercially reasonable efforts to supply its Compound(s) hereunder with an adequate remaining shelf life at the time of Delivery to meet the Study requirements.
8.4 Provision of Compounds .
8.4.1 MSD and/or its Affiliate(s) will deliver the MSD Compound [***] to Companys, or its designees, location as specified by Company (Delivery with respect to such MSD Compound). Title and risk of loss for the MSD Compound [***]. All costs associated with the subsequent transportation, warehousing and distribution of MSD Compound shall be borne by
18
Confidential
Company. Company will, or will cause its designee to: (a) take delivery of the MSD Compound supplied hereunder; (b) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (c) subsequently label and pack the MSD Compound (in accordance with Section 8.5); and promptly ship the MSD Compound to the Study sites for use in the Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement; and (d) provide, from time to time at the reasonable request of MSD, the following information: any applicable chain of custody forms, in-transport temperature recorder(s), records and receipt verification documentation, such other transport or storage documentation as may be reasonably requested by MSD, and usage and inventory reconciliation documentation related to the MSD Compound.
8.4.2 Company is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Company Compounds for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the Company Compounds supplied hereunder. Company shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the Delivery of a given quantity of each Company Compound shall be deemed to occur when [***].
8.5 Labeling and Packaging; Use, Handling and Storage .
8.5.1 The Parties obligations with respect to the labeling and packaging of the Compounds are as set forth in the Clinical Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, MSD and/or its Affiliate(s) shall provide the MSD Compound to Company in the form of [***], and Company shall be responsible for labeling, packaging and leafleting such MSD Compound in accordance with the terms and conditions of the Clinical Quality Agreement and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections.
8.5.2 Company shall: (a) use the MSD Compound solely for purposes of performing the Study; (b) not use the MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (c) label, use, store, transport, handle and dispose of the MSD Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all instructions of MSD. Company shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the MSD Compound, and in particular shall not analyze the MSD Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement.
8.6 Product Specifications . A certificate of analysis shall accompany each shipment of the MSD Compound to Company. Upon request, Company shall provide MSD with a certificate of analysis covering [***] shipment of the Company Compounds used in the Study.
8.7 Changes to Manufacturing . Each Party may make changes from time to time to its Compound(s) or the Manufacturing Site, provided that such changes shall be in accordance with the Clinical Quality Agreement.
19
Confidential
8.8 Product Testing; Noncompliance .
8.8.1 After Manufacturers Release. After Manufacturers Release of the MSD Compound and concurrently with Delivery of the MSD Compound to Company, MSD and/or its Affiliate(s) shall provide Company with such certificates and documentation as are described in the Clinical Quality Agreement (Disposition Package). Company shall, within the time defined in the Clinical Quality Agreement, perform, with respect to the MSD Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Company shall be solely responsible for taking all steps necessary to determine that MSD Compound or Company Compounds, as applicable, is suitable for release before making such MSD Compound or Company Compounds, as applicable, available for human use, and MSD and/or its Affiliate(s) shall provide cooperation or assistance as reasonably requested by Company in connection with such determination with respect to the MSD Compound. For clarity, Companys obligations under the immediately preceding sentence with respect to the MSD Compound shall consist of the performance of acceptance testing procedures and review of the certificates of analysis and other documentation that Company is required to review pursuant to the Clinical Quality Agreement. Company shall be responsible for storage and maintenance of the MSD Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the MSD Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by MSD from time to time. Company shall be responsible for any failure of the MSD Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Company hereunder.
8.8.2 Non-Conformance.
(a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.3.
(b) In the event that any proposed or actual shipment of the MSD Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Company, then unless otherwise agreed to by the Parties, MSD and/or its Affiliate(s) shall replace such MSD Compound as is found to have a Non-Conformance (with respect to MSD Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, [***] with respect to any MSD Compound that is found to have a Non-Conformance at the time of Delivery shall be [***]; provided that, for clarity, [***]. In the event MSD Compound is lost or damaged [***]; provided that Company shall [***]; and provided further that [***].
20
Confidential
(c) Company shall be responsible for, and MSD shall have no obligation or liability with respect to, any Company Compound supplied hereunder that is found to have a Non-Conformance. Company shall replace any Company Compound as is found to have a Non-Conformance (with respect to Company Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, [***] with respect to any Company Compound that is found to have a Non-Conformance at the time of Delivery shall be [***]; provided that, for clarity, [***].
8.8.3 Resolution of Discrepancies. Disagreements regarding any determination of Non-Conformance by Company shall be resolved in accordance with the provisions of the Clinical Quality Agreement.
8.9 Investigations. The process for investigations of any Non-Conformance shall be handled in accordance with the Clinical Quality Agreement.
8.10 Shortage; Allocation . In the event that a Partys Compound(s) is in short supply such that a Party reasonably believes in good faith that it will not be able to fulfill its supply obligations hereunder with respect to its Compound(s), such Party will provide prompt written notice to the other Party thereof (including the shipments of Compound hereunder expected to be impacted and the quantity of its Compound(s) that such Party reasonably determines it will be able to supply) and the Parties will promptly discuss such situation (including how the quantity of Compound(s) that such Party is able to supply hereunder will be allocated within the Study). In such event, the Party experiencing such shortage shall (a) use its commercially reasonable efforts to remedy the situation giving rise to such shortage and to take action to minimize the impact of the shortage on the Study, and (b) [***].
8.11 Records; Audit Rights. Company shall keep complete and accurate records pertaining to its use and disposition of MSD Compound (including its storage, shipping (cold chain) and chain of custody activities) and, upon request of MSD, shall make such records open to review by MSD for the purpose of conducting investigations for the determination of MSD Compound safety and/or efficacy and Companys compliance with this Agreement with respect to the MSD Compound.
8.12 Quality. Quality matters related to the Manufacture of the Compounds shall be governed by the terms of the Clinical Quality Agreement in addition to the relevant quality provisions of this Agreement.
8.13 Quality Control. Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Compound(s), and for validation, documentation and release of its Compound(s) and such other quality assurance and quality control procedures as are required by the Specifications, cGMPs and the Clinical Quality Agreement.
8.14 Audits and Inspections. The Parties audit and inspection rights related to this Agreement shall be governed by the terms of the Clinical Quality Agreement.
8.15 Recalls. Recalls of the Compounds shall be governed by the terms of the Clinical Quality Agreement.
21
Confidential
8.16 VAT.
8.16.1 It is understood and agreed between the Parties that any payments made and any other consideration given under this Agreement are each exclusive of any value added or similar tax (VAT), which shall be added thereon as applicable and at the relevant rate. Subject to Section 8.16.1, where VAT is properly charged by the supplying Party and added to a payment made or other consideration provided (as applicable) under this Agreement, the Party making the payment or providing the other consideration (as applicable) will pay the amount of VAT properly chargeable only on receipt of a valid tax invoice from the supplying Party issued in accordance with the laws and regulations of the country in which the VAT is chargeable. Each Party agrees that it shall provide to the other Party any information and copies of any documents within its Control to the extent reasonably requested by the other Party for the purposes of (a) determining the amount of VAT chargeable on any supply made under this Agreement, (b) establishing the place of supply for VAT purposes, or (c) complying with its VAT reporting or accounting obligations.
8.16.2 Where one Party or its Affiliate (the First Party) is treated as making supply of goods or services in a particular jurisdiction (for VAT purposes) [***], and the other Party or its Affiliate (the Second Party) is treated as receiving such supply in the same jurisdiction, thus resulting in an amount of VAT being properly chargeable on such supply, the Second Party shall only be obliged to pay to the First Party the amount of VAT properly chargeable on such supply (and no other amount). The Second Party shall pay such VAT to the First Party on receipt of a valid VAT invoice from the First Party (issued in accordance with the laws and regulations of the jurisdiction in which the VAT is properly chargeable). Each Party agrees to (a) use its reasonable efforts to determine and agree the value of the supply that has been made and, as a result, the corresponding amount of VAT that is properly chargeable and (b) provide to the other Party any information or copies of documents in its Control as are reasonably necessary to evidence that such supply will take, or has taken, place in the same jurisdiction (for VAT purposes).
9. |
Confidentiality. |
9.1 Confidential Information. Subject to Section 13.4.8, Company and MSD agree to hold in confidence any Confidential Information provided by or on behalf of the other Party, and neither Party shall use Confidential Information of the other Party except to fulfill such Partys obligations under this Agreement or exercising its rights. Without limiting the foregoing, the Receiving Party may not, without the prior written permission of the Disclosing Party, disclose any Confidential Information of the Disclosing Party to any Third Party except to the extent disclosure (a) is required by Applicable Law or the rules of a security exchange; (b) is permitted pursuant to the terms of this Agreement; or (c) is necessary for the conduct of the Study, and in each case ((a) through (c)), provided that the Receiving Party shall provide reasonable advance notice to the Disclosing Party before making such disclosure. For the avoidance of doubt, Company may, without MSDs consent, disclose Confidential Information to clinical trial sites and clinical trial investigators performing the Study, the data safety monitoring and advisory board relating to the Study, and Regulatory Authorities working with Company on the Study, in each case, to the extent necessary for the performance of the Study and provided that such Persons (other than governmental entities) are bound by an obligation of confidentiality at least as stringent as the obligations contained herein.
22
Confidential
9.2 Inventions. Notwithstanding the foregoing: (a) Inventions that constitute Confidential Information and are jointly owned by the Parties, shall constitute the Confidential Information of both Parties and each Party shall have the right to use and disclose such Confidential Information consistent with Articles 10, 11 and 12; and (b) Inventions that constitute Confidential Information and are solely owned by one Party shall constitute the Confidential Information of that Party and each Party shall have the right to use and disclose such Confidential Information consistent with Articles 10, 11 and 12.
9.3 Personal Identifiable Data. All Confidential Information containing Personal Data (including Special Categories of Data) shall be handled in accordance with all Data Protection Laws.
10. |
Intellectual Property. |
10.1 Joint Ownership and Prosecution.
10.1.1 All rights to all Inventions relating to, or covering, [***] that are not MSD Inventions or Company Inventions [***] (each a Jointly Owned Invention) shall be owned jointly by Company and MSD [***]
10.1.2 Each Party shall have the right to [***].
10.1.3 [***]
10.1.4 Except as expressly provided in this Agreement and in furtherance and not in limitation of Section 9.1, each Party agrees to file no patent application based on the other Partys Confidential Information, and to not give any assistance to any Third Party for such application, without the other Partys prior written authorization.
10.1.5 [***] shall have the first right, but not the obligation, to initiate legal action to enforce all Joint Patents against infringement and to protect all Jointly Owned Inventions from misappropriation by any Third Party, [***] or to defend any declaratory judgment action relating thereto, at its sole expense. In the event that [***] fails to initiate or defend any such action within [***] after being first notified of such infringement, [***] shall have the right to do so at its sole expense. [***] shall have the first right, but not the obligation, to initiate legal action to enforce any applicable Joint Patent against infringement and to protect all applicable Jointly Owned Inventions from misappropriation by any Third Party, [***] or to defend any declaratory judgment action relating thereto, at its sole expense. In the event that [***] fails to initiate or defend any such action within [***] after being first notified of such infringement, [***] shall have the right to do so at its sole expense. [***].
10.1.6 If one Party brings any prosecution or enforcement action or proceeding against a Third Party with respect to any [***], the second Party agrees to be joined as a party plaintiff where necessary and to give the first Party reasonable assistance and authority to file and prosecute the suit. The costs and expenses of the Party bringing suit under this Section 10.1.6 shall be borne by such Party, and any damages or other monetary awards recovered shall be shared as follows: [***]. A settlement or consent judgment or other voluntary final disposition of a suit under this Section 10.1.6 may not be entered into without the consent of the Party not bringing the suit.
23
Confidential
10.2 Inventions Owned by Company. Notwithstanding anything to the contrary contained in Section 10.1, the Parties agree that all rights to Inventions relating solely to, or covering solely, a Company Compound or a Company Class Compound, and any improvements related solely to, or solely covering, a Company Compound or a Company Class Compound, [***], are the exclusive property of Company (Company Inventions). Company shall be entitled to file and prosecute in its own name relevant patent applications and to own resultant patent rights for any Company Invention. For the avoidance of doubt, any Invention [***]
10.3 Inventions Owned by MSD. Notwithstanding anything to the contrary contained in Section 10.1, the Parties agree that all rights to Inventions relating solely to, or covering solely, the MSD Compound or a PD-1 Antagonist, and any improvements related solely to, or solely covering, the MSD Compound or a PD-1 Antagonist, [***], are the exclusive property of MSD (MSD Inventions). MSD shall be entitled to file and prosecute in its own name relevant patent applications and to own resultant patent rights for any MSD Invention. For the avoidance of doubt, any Invention [***]
10.4 Mutual Freedom to Operate for Combination Inventions.
10.4.1 Company License to MSD. Company hereby grants to MSD a non-exclusive, worldwide, royalty-free, fully paid-up, transferable and sublicensable license [***].
10.4.2 MSD License to Company. MSD hereby grants to Company a non-exclusive, worldwide, royalty-free, fully paid-up, transferable and sublicensable license [***].
10.4.3 No Other Rights. For clarity, the terms of this Section 10.4 do not provide MSD or Company with any rights, title or interest or any license to the other Partys intellectual property rights [***].
10.4.4 Termination. [***].
10.5 Right of First Negotiation.
10.5.1 Notice. From the Effective Date until [***] (the ROFN Period), if (a) Company seeks to license or enter into any collaboration or similar transaction granting a Third Party rights to develop or commercialize a Company Compound (each such license, collaboration or any similar transaction granting a Third Party such rights, a ROFN Transaction) or (b) Company receives a bona fide unsolicited offer from a Third Party for a ROFN Transaction that the Company does not reject without further discussions with such Third Party (each such offer, an Unsolicited Offer), Company shall promptly notify MSD in writing of the existence of such proposed ROFN Transaction or Unsolicited Offer, as applicable.
10.5.2 MSD Right. Following notification to MSD by Company of the first proposed ROFN Transaction or Unsolicited Offer received by Company during the ROFN Period, MSD shall have the right, but not the obligation, to negotiate and enter into a transaction with Company to develop and commercialize such Company Compound(s) (the MSD Right). If MSD
24
Confidential
desires to exercise the MSD Right, it shall so notify Company in writing within [***] after receiving such written notice from Company. Thereafter, the Parties shall negotiate the terms of a proposed transaction for a period expiring upon the date that is [***] after MSD delivers such written notice to Company (the Negotiation Period). The Negotiation Period may be extended for additional periods of time as agreed by the Parties in writing before expiration of the Negotiation Period. For avoidance of doubt, expiration of the ROFN Period or MSDs decision to not exercise the MSD Right shall not affect the Term nor change either Partys obligations to perform under this Agreement; [***].
10.5.3 Limitations. If, once Company has notified MSD of a ROFN Transaction or Unsolicited Offer, (a) MSD does not timely exercise the MSD Right within the foregoing [***] period, or (b) the Parties do not enter into definitive contractual documentation for the applicable transaction during the Negotiation Period, Company shall be free to negotiate and enter into such ROFN Transaction with any Third Party, with no further obligation to MSD with respect thereto. Companys obligation to notify MSD under Section 10.5.1 and the MSD Right under Section 10.5.2 shall immediately expire upon any Change of Control of Company, and [***].
11. |
Reprints; References in Publication. |
Consistent with applicable copyright and other laws, each Party may use, refer to, and disseminate reprints of scientific, medical and other published articles and materials from journals, conferences and/or symposia relating to the Study that disclose the name of a Party, provided, however, that such use does not constitute an endorsement of any commercial product or service by the other Party.
12. |
Publications; Press Releases. |
12.1 Clinical Trial Registry. Company shall register the Study with the Clinical Trials Registry located at www.clinicaltrials.gov and is committed to timely publication of the results following Study Completion, after taking appropriate action to secure intellectual property rights (if any) arising from the Study. The publication of the results of the Study will be in accordance with the Protocol.
12.2 Publication. Each Party shall use reasonable efforts to publish or present the results of the Study in scientific papers or in scientific conferences in accordance with accepted scientific practice and in accordance with this Section 12.2. The Parties agree that prior to submission of the results of the Study for publication or presentation or any other dissemination of such results including oral dissemination, the publishing Party shall invite the other to comment on the content of the material to be published, presented, or otherwise disseminated according to the following procedure:
12.2.1 At least [***], the publishing Party shall provide to the other Party the full details of the proposed publication, presentation, or dissemination in an electronic version (cd-rom or email attachment), and the non-publishing Party shall have the right to review and comment on such proposed publication. Upon written request from the other Party, the publishing Party agrees not to submit data for publication/presentation/dissemination for an additional [***] in order to allow for actions to be taken to preserve rights for patent protection.
25
Confidential
12.2.2 The publishing Party shall give reasonable consideration to any request by the other Party made within the periods mentioned in Section 12.2.1 to modify the proposed publication and the Parties shall work in good faith and in a timely manner to resolve any issue regarding the content for publication.
12.2.3 The publishing Party shall, upon reasonable request by the other Party, remove the Confidential Information of the other Party from the proposed publication before finalizing the publication.
12.3 Press Releases. Promptly following the Effective Date, Company may issue the press release attached hereto as Appendix D. Unless otherwise required by Applicable Law or rules of a securities exchange upon which a Partys securities are listed, neither Party shall make any other public announcement concerning this Agreement without the prior written consent of the other Party. To the extent a Party desires to make such public announcement, such Party shall provide the other Party with a draft thereof at least [***] prior to the date on which such Party would like to make the public announcement. If a Party believes a disclosure concerning this Agreement is necessary to comply with Applicable Law or rules of a securities exchange, such Party shall promptly inform the other Party of the disclosure that is being sought, and consult and cooperate fully with the other Party in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Any information disclosed shall remain otherwise subject to the confidentiality and non-use provisions of this Section, and the Party disclosing such information shall take all steps reasonably necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such information.
13. |
Representations and Warranties; Disclaimers. |
13.1 Due Authorization. Each of Company and MSD represents and warrants to the other that: (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (c) this Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms.
13.2 Compounds.
13.2.1 Company Compounds. Company hereby represents and warrants to MSD that: (a) Company has the full right, power and authority to grant all of the licenses granted to MSD under this Agreement; and (b) Company Controls the Company Compounds.
13.2.2 MSD Compound. MSD hereby represents and warrants to Company that: (a) MSD has the full right, power and authority to grant all of the licenses granted to Company under this Agreement; and (b) MSD and/or its Affiliate(s) Controls the MSD Compound.
13.3 Results. Company does not undertake that the Study shall lead to any particular result, nor is the success of the Study guaranteed. Neither Party shall be liable for any use that the other Party may make of the Clinical Data nor for advice or information given in connection therewith.
26
Confidential
13.4 Anti-Corruption.
13.4.1 In performing their respective obligations hereunder, the Parties acknowledge that the corporate policies of Company and MSD and their respective Affiliates require that each Partys business be conducted within the letter and spirit of the law. By signing this Agreement, each Party agrees to conduct the business contemplated herein in a manner that is consistent with all Applicable Law, including the Stark Act, Anti-Kickback Statute, Sunshine Act, and the U.S. Foreign Corrupt Practices Act, good business ethics, and its ethics and other corporate policies and agrees to abide by the spirit of the other Partys guidelines, which may be provided by such other Party from time to time.
13.4.2 Specifically, each Party represents and warrants that it has not, and covenants that it, its Affiliates, and its and its Affiliates directors, employees, officers, and anyone acting on its behalf, will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any action in furtherance of, any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery.
13.4.3 Neither Party shall contact, or otherwise knowingly meet with, any Government Official for the purpose of discussing activities arising out of or in connection with this Agreement, without the prior written approval of the other Party, except where such meeting is consistent with the purpose and terms of this Agreement and in compliance with Applicable Law.
13.4.4 Each Party represents and warrants that it (a) is not excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs; and (b) has not employed or subcontracted with any Person for the performance of the Study who is excluded, debarred, suspended, proposed for suspension or debarment, or is in Violation or otherwise ineligible for government programs.
13.4.5 Each Party represents and warrants that, except as disclosed to the other in writing prior to the Effective Date, such Party: (a) does not have any interest that directly or indirectly conflicts with its proper and ethical performance of this Agreement; (b) shall maintain arms length relations with all Third Parties with which it deals for or on behalf of the other in performance of this Agreement; and (c) has provided complete and accurate information and documentation to the other Party, the other Partys Affiliates and its and their personnel in the course of any due diligence conducted by the other Party for this Agreement, including disclosure of any officers, employees, owners or Persons directly or indirectly retained by such Party in relation to the performance of this Agreement who are Government Officials or relatives of Government Officials. Each Party shall make all further disclosures to the other Party as are necessary to ensure the information provided remains complete and accurate throughout the Term. Subject to the foregoing, each Party agrees that it shall not hire or retain any Government Official to assist in its performance of this Agreement, with the sole exception of conduct of or participation in clinical trials under this Agreement, provided that such hiring or retention shall be subject to the completion by the hiring or retaining Party of a satisfactory anti-corruption and bribery (e.g., FCPA) due diligence review of such Government Official. Each Party further covenants that any future information and documentation submitted to the other Party as part of further due diligence or a certification shall be complete and accurate.
27
Confidential
13.4.6 Each Party shall have the right during the Term, [***], 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 Section 13.4. Each Party shall provide commercially reasonable cooperation and grant commercially reasonable access to relevant documents and materials as reasonably required by the Party requesting such investigation and audit.
13.4.7 Each Party shall use commercially reasonable efforts to ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and that each document upon which entries in such books and records are based is complete and accurate in all material respects. Each Party further represents, warrants and covenants that all books, records, invoices and other documents relating to payments and expenses under this Agreement are and shall be complete and accurate and reflect in reasonable detail the character and amount of transactions and expenditures. Each Party shall maintain a system of internal accounting controls reasonably designed to ensure that no off-the-books or similar funds or accounts will be maintained or used in connection with this Agreement.
13.4.8 Each Party agrees that in the event that the other Party believes in good faith that there has been a possible violation of any provision of Section 13.4, such other Party may make full disclosure of such belief and related information needed to support such belief at any time and for any reason to any competent government bodies and agencies, and to anyone else such Party determines in good faith has a legitimate need to know.
13.4.9 Each Party shall comply with its own ethical business practices policy and any corporate integrity agreement (if applicable) to which it is subject, and shall conduct its Study related activities in accordance with Applicable Law. Each Party shall ensure that all of its employees involved in performing its obligations under this Agreement are made specifically aware of the compliance requirements under this Section 13.4. In addition, each Party shall ensure that all such employees participate in and complete mandatory compliance training to be conducted by each Party, including specific training on anti-bribery and corruption, prior to his/her performance of any obligations or activities under this Agreement. Each Party shall certify its continuing compliance with the requirements under this Section 13.4 on a periodic basis during the Term in such form as may be reasonably specified by the other Party.
13.4.10 Each Party shall have the right to terminate this Agreement immediately upon violation of this Section 13.4 in accordance with Section 6.5.
13.5 DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED HEREIN, MSD MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE MSD COMPOUND, AND COMPANY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE COMPANY COMPOUNDS.
28
Confidential
14. |
Insurance; Indemnification; Limitation of Liability. |
14.1 Insurance. Each Party warrants that it maintains a policy or program of insurance or self-insurance at levels sufficient to support the indemnification obligations assumed herein. Upon request, a Party shall provide evidence of such insurance.
14.2 Indemnification.
14.2.1 Indemnification by Company. Company agrees to defend, indemnify and hold harmless MSD, its Affiliates, and its and their employees, directors, subcontractors and agents from and against any loss, damage, reasonable costs and expenses (including reasonable attorneys fees and expenses) incurred in connection with any claim, proceeding, or investigation by a Third Party arising out of [***] (a Liability), except to the extent that such Liability [***].
14.2.2 Indemnification by MSD. MSD agrees to defend, indemnify and hold harmless Company, its Affiliates, and its and their employees, directors, Subcontractors and agents from and against any Liability to the extent such Liability was directly caused by [***].
14.2.3 Procedure. The obligations of MSD and Company under this Section 14.2 are conditioned upon the delivery of written notice to MSD or Company, as the case might be, of any potential Liability within a reasonable time after a Party becomes aware of such potential Liability. The indemnifying Party will have the right to assume the defense of any suit or claim related to the Liability (using counsel reasonably satisfactory to the indemnified Party) if it has assumed responsibility for the suit or claim in writing; provided that the indemnified Party may assume the responsibility for such defense to the extent the indemnifying Party does not do so in a timely manner. The indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense. The Party controlling such defense (the Defending Party) shall keep the other Party (the Other Party) advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the Other Party with respect thereto. The Defending Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Other Party, which shall not be unreasonably withheld. The Defending Party, but solely to the extent the Defending Party is also the indemnifying Party, shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Other Party from all liability with respect thereto or that imposes any liability or obligation on the Other Party without the prior written consent of the Other Party.
14.2.4 Study Subjects. Company shall not offer compensation on behalf of MSD to any Study subject or bind MSD to any indemnification obligations in favor of any Study subject. MSD shall not offer compensation on behalf of Company to any Study subject or bind Company to any indemnification obligations in favor of any Study subject.
14.3 LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES OR SUBCONTRACTORS) BE LIABLE TO THE OTHER PARTY UNDER ANY THEORY FOR, NOR SHALL ANY INDEMNIFIED PARTY HAVE THE RIGHT TO RECOVER, ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES OR ANY PUNITIVE DAMAGES OR ANY LOST PROFIT,
29
Confidential
LOST SALE OR LOST OPPORTUNITY DAMAGES (WHETHER SUCH CLAIMED DAMAGES ARE DIRECT OR INDIRECT), WHETHER ARISING DIRECTLY OR INDIRECTLY OUT OF (A) THE MANUFACTURE OR USE OF ANY COMPOUND SUPPLIED HEREUNDER OR (B) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT OR ANY REPRESENTATION, WARRANTY OR COVENANT CONTAINED IN OR MADE PURSUANT TO THIS AGREEMENT, EXCEPT THAT SUCH LIMITATION SHALL NOT APPLY TO DAMAGES PAID OR PAYABLE TO A THIRD PARTY BY AN INDEMNIFIED PARTY FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION HEREUNDER OR WITH RESPECT TO DAMAGES ARISING OUT OF OR RELATED TO A PARTYS BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT WITH RESPECT TO [***].
15. |
Use of Name. |
Except as otherwise provided herein or required under Applicable Law, neither Party shall have any right, express or implied, to use in any manner the name or other designation of the other Party or any other trade name, trademark or logo of the other Party for any purpose in connection with the performance of this Agreement without the other Partys prior written consent.
16. |
Force Majeure. |
If, in the performance of this Agreement, one of the Parties is prevented, hindered or delayed by reason of any cause beyond such Partys reasonable control (e.g., war, riots, fire, strike, epidemics, pandemics, acts of terror, governmental laws), such Party shall be excused from performance to the extent that it is necessarily prevented, hindered or delayed (Force Majeure). 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 will 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.
17. |
Entire Agreement; Amendment; Waiver. |
This Agreement, together with the Appendices and Schedules hereto and the Related Agreements, constitutes the sole, full and complete agreement by and between the Parties with respect to the subject matter of this Agreement, and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto, including but not limited to the [***] (the Prior CDA), are superseded by this Agreement. As of the Effective Date, all confidential information exchanged under the Prior CDA shall be considered Confidential Information exchanged under this Agreement. In the event of a conflict between a Related Agreement and this Agreement, the terms of this Agreement shall control. No amendments, changes, additions, deletions or modifications to or of this Agreement shall be valid unless reduced to writing and signed by the Parties hereto. 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 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 said other Party whether of a similar nature or otherwise.
30
Confidential
18. |
Assignment and Affiliates. |
Neither Party shall assign or transfer this Agreement without the prior written consent of the other Party; provided, however, that either Party may assign all or any part of this Agreement without the other Partys consent: (a) to one or more of its Affiliates, and any and all rights and obligations of either Party may be exercised or performed by its Affiliates, provided in each case, that such Affiliates agree to be bound by this Agreement and such Party shall remain responsible for compliance by its Affiliates with the terms and conditions of this Agreement and shall remain liable for any breaches by its Affiliates of this Agreement; or (b) in connection with its Change of Control; further, provided, that in the case of Company, Company must notify MSD as soon as practically possible following execution of a definitive agreement with respect to a Change of Control and, in any event, prior to the public announcement of the Change of Control and no later than [***] following execution of a definitive agreement with respect to a Change of Control). Any permitted assignee shall assume all obligations of its assignor under this Agreement, and Company, including its acquiring party, shall further adopt reasonable procedures to prevent any use of: (i) Confidential Information of MSD and (ii) Clinical Data in any PD-1 Antagonist program, in each case, outside of Companys rights to use such data and information under this Agreement. This Agreement shall be binding upon the successors and permitted assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Partys successors and permitted assigns to the extent necessary to carry out the intent of the Agreement. Any assignment not in accordance with this Article 18 shall be null, void and of no legal effect.
19. |
Change of Control. |
If Company undergoes a Change of Control in which the acquiring party owns or controls a competing PD-1 Antagonist, then upon MSDs request, the Parties and the acquiring party shall engage in good faith discussion and shall adopt reasonable procedures to be agreed by MSD to prevent the disclosure of Sensitive Information beyond Companys personnel having access to or knowledge of Sensitive Information prior to the Change of Control and other personnel of the Change of Control partner approved by MSD, and to control the dissemination of Sensitive Information disclosed after the Change of Control to prevent the use of Sensitive Information for the development or commercialization of competing PD-1 Antagonist products. Such procedures shall include provisions allowing designated management personnel to review and evaluate on a comparative basis business and technical plans and information regarding the Combination, the MSD Compound, and competing PD-1 Antagonist products, in connection with portfolio decision-making (but not, for clarity, for use in development or commercialization of competing PD-1 Antagonist products).
20. |
Invalid Provision. |
If any provision of this Agreement is held to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect and will not be affected by the illegal, invalid or unenforceable provision. In lieu of the illegal, invalid or unenforceable provision, the Parties shall negotiate in good faith to agree upon a reasonable provision that is legal, valid and enforceable to carry out as nearly as practicable the original intention of the entire Agreement.
31
Confidential
21. |
No Additional Obligations. |
Company and MSD have no obligation to renew this Agreement or apply this Agreement to any clinical trial other than the Study. Nothing in this Agreement obligates the Parties to enter into any other agreement (other than the Related Agreements) at this time or in the future.
22. |
Governing Law; Dispute Resolution. |
22.1 The Parties shall attempt in good faith to settle all disputes arising out of or in connection with this Agreement in an amicable manner. Any claim, dispute or controversy arising out of or relating to this Agreement, including the breach, termination or validity hereof or thereof, shall be governed by and construed in accordance with the substantive laws of the State of New York, without giving effect to its choice of law principles.
22.2 Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed or maintained notwithstanding any ongoing discussions between the Parties.
32
Confidential
23. |
Notices. |
All notices or other communications that are required or permitted hereunder shall be in writing and delivered personally, sent by facsimile (and promptly confirmed by personal delivery or overnight courier), or sent by internationally-recognized overnight courier addressed as follows:
If to Company, to:
IO Biotech ApS
[***]
If to MSD, to:
MSD International GmbH
MSD International Business GmbH
[***]
MSD International Business GmbH
[***]
With copies (which shall not constitute notice) to:
[***]
24. |
Relationship of the Parties. |
The relationship between the Parties is and shall be that of independent contractors, and does not and shall not constitute a partnership, joint venture, agency or fiduciary relationship. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or take any actions, that are binding on the other Party, except with the prior written consent of the other Party to do so. All Persons employed by a Party will be the 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.
25. |
Counterparts and Due Execution. |
This Agreement and any amendment may be executed in any number of counterparts (including by way of facsimile or electronic transmission), each of which shall be deemed an original, but all of which together shall constitute one and the same instrument, notwithstanding any electronic transmission, storage and printing of copies of this Agreement from computers or printers. When executed by the Parties, this Agreement shall constitute an original instrument, notwithstanding any electronic transmission, storage and printing of copies of this Agreement from computers or printers. For clarity, facsimile signatures and signatures transmitted via PDF shall be treated as original signatures.
33
Confidential
26. |
Construction. |
Except where the context otherwise requires, wherever used, the singular will include the plural, the plural the singular, the use of any gender will be applicable to all genders, and the word or is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term including as used herein shall be deemed to be followed by the phrase without limitation or like expression. The term will as used herein means shall. The terms hereof, hereto, herein and hereunder and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement. References to Article, Section, Appendix or Schedule are references to the numbered sections of this Agreement and the appendices attached to this Agreement, unless expressly stated otherwise. Except where the context otherwise requires, references to this Agreement shall include the appendices attached to this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction will be applied against either Party hereto.
[Remainder of page intentionally left blank.]
34
Confidential
IN WITNESS WHEREOF, the respective representatives of the Parties have executed this Agreement as of the Effective Date.
IO Biotech ApS | ||
By: | ||
Name | ||
Title | ||
Date | ||
MSD International GmbH | ||
By: | ||
Name | ||
Title | ||
Date | ||
MSD International Business GmbH | ||
By: | ||
Name | ||
Title |
Exhibit 10.14
Execution version
Service Agreement
IO Biotech ApS Mai-Britt Zocca
This service agreement is entered into between:
IO Biotech ApS
[***]
(the Company)
and
Mai-Britt Zocca
(the CEO)
1 |
Date of employment |
1.1 |
With effect from 1 January 2018 the CEO is employed as Chief Executive Officer of the Company on the terms and conditions set forth in this Service Agreement. The CEO has been CEO of the Company since 1 January 2015 and this Service Agreement replaces all previous service agreements between the parties. |
1.2 |
The CEO is registered as Chief Executive Officer of the Company with the Danish Business Authority. |
2 |
The duties of the CEO |
2.1 |
The CEO is responsible for the daily management of the Company subject to the instructions and the guidelines issued by the Board of Directors. |
2.2 |
The Board of Directors determines the directions applicable to the activities of the Company at any time. It is the responsibility of the CEO towards the Board of Directors that the activities of the Company are carried out in accordance with these directions, the Companys Articles of Association, and current legislation. |
2.3 |
Any and all matters outside the normal day-to-day operation of the Company shall be submitted by the CEO to the Board of Directors. |
2.4 |
The CEO is entitled to sign on behalf of the Company in matters concerning the day-to-day operations of the Company, subject to the restrictions in this Service Agreement and otherwise in accordance with the role of signature in the Companys Articles of Association. |
3 |
Working bours and other work |
3.1 |
The CEO has no fixed weekly working hours. |
3.2 |
The CEO is not entitled to overtime pay or standby allowance, and likewise the CEO is not entitled to take time off in lieu of overtime. |
3.3 |
Upon execution of this Service Agreement, the CEO bolds the following other positions all of which have been agreed and accepted by the Company effective from 1 January 2015: |
- |
[***]; CEO and founder. |
- |
[***], CEO and founder. |
- |
[***], co-founder (minority shareholder), BD. |
3.4 |
The Company acknowledges and agrees that the CEO may continue the activities described in clause 3.3 as long as these activities do not interfere with or hinder the fulfilment of her obligations under this Service Agreement. Except as listed in clause 3.3 above, the CEO shall not without the written consent from the Board of Directors be the owner of or an active or dormant participant in any other commercial business or hold any paid or unpaid office, or take up any paid work, such consent shall not be unreasonably delayed or withheld. However, the Board of Directors of the Company may always oppose the CEOs involvement in competing activities or activities that in other respects are inconsistent with the CEOs obligations under this Service Agreement. |
3.5 |
The CEO is entitled to make normal capital investments (in Danish: kapitalanbringelse) in assets, which are usually the subject of such investment, and which do not include personal working efforts of any kind and/or decisive influence. |
3.6 |
The CEO shall inform the Chairman of the Board of Directors of any material personal financial problems that may result in the CEO not being able to honour the CEOs debts when due. |
4 |
Remuneration |
4.1 |
Effective from 1 January 2018, the annual gross salary on a full time basis amounts to DKK 1,800,000. The salary is to be paid 1/12 monthly in arrears not later than on the last business day of each month to an account designated by the CEO. |
4.2 |
The gross salary is subject to a review either by the Chairman of the Board of Directors or the remuneration committee once a year in January, and for the first time in January 2019. Any regulation of the gross salary will be effective from 1 January of the year in question. |
5 |
Pension |
5.1 |
The CEO is not covered by a pension scheme arranged by the Company. |
6 |
Bonus |
6.1 |
In addition to the remuneration in clause 4.1 the CEO shall be entitled to a milestone dependent bonus of up to 3 months salary. |
6.2 |
The milestones and the individual bonus amounts relating to such milestones shall be defined by the Board of Directors on an annual basis or when existing milestones are met, whichever is sooner. The adjustment, if any, will be determined at the discretion of the Board of Directors. The Board of Directors decides at its own discretion to what extend milestones in any given year have been met. |
6.3 |
The milestone bonus in force from time to time is to be further described in a separate document. |
6.4 |
Bonus amounts do not generate other salary payments. |
2
7 |
Other benefits |
7.1 |
The Company will pay all the CEOs expenses for a laptop computer, a mobile telephone and internet connection at the CEOs private address. |
7.2 |
Upon the actual termination of the employment irrespective of cause the CEO must upon request from the Company return the above benefits not later than on the day when the CEOs duty to work ceases. At this time the Companys payment of private mobile telephone and internet connection will also cease. This applies, irrespective of whether the CEO receives salary after this date. The CEO cannot exercise any lien on the above benefits. |
7.3 |
During any remaining part of the notice period the CEO will receive a monthly amount corresponding to the actual tax value of the above benefits. |
7.4 |
Any tax consequences to the CEO arising out of the above benefits are of no concern to the Company. |
8 |
Entertainment and travel expenses |
8.1 |
The CEOs reasonable costs in connection with travel and entertainment in the interest of the Company will be refunded by the Company subject to receipts in accordance with the Companys guidelines in force from time to time. The CEO should account for travel and entertainment expenses soon as possible after the expenses have been paid. |
9 |
Holidays |
9.1 |
The CEO is entitled to six weeks holiday with pay per calendar year. |
9.2 |
The holiday should be taken subject to agreement with the Chairman of the Board of Directors. |
9.3 |
The CEO is obliged to take any remaining holidays during the notice period and will not be entitled to compensation, if the CEO bas been unable to take the holidays prior to resignation. |
9.4 |
The CEO is not covered by the Danish Holiday Act. |
10 |
Sickness |
10.1 |
The CEO is entitled to receive full salary during periods of sickness. |
10.2 |
The Company may terminate this Service Agreement subject to three months written notice effective from the end of a month, if, due to sickness, the CEO bas been unable to perform the obligations as CEO during a consecutive period of six months or in total eight months within a period of 12 months. |
11 |
Confidentiality, duty of loyalty, and return of materials |
11.1 |
The CEO has a duty of confidentiality with respect to everything that the CEO may learn in connection with the performance of the CEOs duties. The duty of confidentiality shall continue to apply after expiry of the employment. |
3
11.2 |
During the period or employment including during a notice period the CEO is obliged to observe a duty of loyalty towards the Company. This includes inter alia but not exhaustively: |
- |
that the CEO is not entitled to commence any activities or, directly or indirectly, be engaged in any activities which directly or indirectly compete with the Companys activities. |
11.3 |
Failure to observe the CEOs duty of confidentiality and loyalty may have consequences for the CEOs employment. |
11.4 |
Upon the actual termination of the employment irrespective of cause the CEO must return all materials and all assets in the CEOs possession which belong to the Company or relate to the Companys activities. No lien may be exercised on any materials belonging to the Company. |
12 |
Non-competition clause |
12.1 |
During the employment the CEO is not entitled to commence any activities or, directly or indirectly, be engaged in any activities (as owner, director, employee, agent, consultant or the like) which, directly or indirectly, compete with the activities of the Company or any group-affiliated companies. |
12.2 |
Furthermore, the Company is entitled in its sole discretion to require that the CEO for a period of 12 months after termination of the employment, calculated from the last day the CEO receives salary is not entitled to commence any activities or, directly or indirectly, be engaged in any activities (as owner, director, employee, agent, consultant or the like) which, directly or indirectly, compete with the activities of the Company or any group-affiliated companies, subject to the Company in such case being obligated to pay compensation to the CEO during such period equal to the fixed remuneration paid at the time of termination of the employment. The Company must invoke its right under this clause 12.2 no later than 30 days after the Company gives notice of termination (including in the case of summary dismissal) to the CEO or the CEO gives notice of termination, as the case may be. |
12.3 |
Activities that competes directly or indirectly with the business of the Company and which the CEO hence is prevented of being engaged in pursuant to clauses 12.1 and 12.2 shall encompass therapies targeting immune modulation for the treatment and prevention of cancer. |
12.4 |
The non-competition clause shall lapse if the employment is terminated by the Company, without the CEO having given reasonable cause for such termination, or if the CEO terminates the employment, and the Companys omission to fulfil its obligations has given the CEO valid reason for terminating the employment. |
12.5 |
The non-competition clause will apply globally. |
4
12.6 |
Any breach of the non-competition clause may be subject to injunction. Furthermore, the CEO will, apart from damages, be obliged to pay on agreed penalty (in Danish: konventionalbod) of DKK 100,000, each time a breach occurs. If the breach concerns an ongoing situation which is in breach of the non-competition clause, one breech is deemed to have occurred for each calendar month commenced, during which the breach continues. Payment by the CEO of damages and/or an agreed penalty will not cause the non-competition clause to terminate and will not exclude the Company from applying other statutory relief, including injunction. |
12.7 |
To the extent the Company obtains penalties and/or damages under this clause 12, the Company shall not be entitled to obtain penalties and/or damages in respect of the same loss/breach under the shareholders agreement regarding the Company to which the CEO is a party with regard to the same subject matter. |
13 |
Non-solicitation clause |
13.1 |
During the employment and for a period of 12 months after the termination of the employment irrespective of cause calculated from the last day the CEO received salary, the CEO is not entitled, directly or indirectly, to have any commercial contact, including by employment, with companies or persons who at any time whatsoever within the last 18 months prior to the date of termination have been customers of or had commercial relations to the Company or any group-affiliated companies. |
13.2 |
No separate compensation is paid for undertaking this non-solicitation clause. |
13.3 |
Any breach of the non-solicitation clause may be subject to injunction. Furthermore, the CEO will, apart from damages, be obliged to pay an agreed penalty (in Danish: konventionalbod) of DKK 100,000, for each time a breach occurs. If the breach concerns an ongoing situation which is in breach of the non-solicitation clause, one breach is deemed to have occurred for each calendar month commenced, during which the breach continues. Payment by the CEO of damages and/or agreed penalty will not cause the non-solicitation clause to terminate and will not exclude the Company from applying other statutory relief, including injunction. |
13.4 |
To the extent the Company obtains penalties and/or damages under this clause 13, the Company shall not be entitled to obtain penalties and/or damages in respect of the same loss/breach under the shareholders agreement regarding the Company to which the CEO is a party with regard to the same subject matter. |
14 |
Insurance & Limitation of liability |
14.1 |
The Company undertakes to take out and maintain a D&O insurance program (in Danish ledelsesansvarsforsikring) providing a cover of at least DKK 5,000,000 per event per year and a cover for litigation costs of at least DKK 1,250,000 per year per event, as well as any mandatory insurance programs such as a Workmans Compensations program (In Danish arbejdsskadeforsikring). |
14.2 |
In case of the CEO becoming liable to the Company under this Service Agreement for losses incurred related to the CEOs employment with the Company, the Company must primarily seek compensation from the insurance programme taken out as per clause 14.1 above and only upon exhaustion thereof seek compensation from the CEO. Liquidated |
5
damages pursuant to clauses 12.6 and 13.3 shall only be incurred if the CEO does not remedy the breach alleged within 10 calendar days from having been notified about an alleged breach. The accumulated liabilities of the CEO, including both losses incurred and liquidated damages, for any breach of this agreement shall in no event exceed DKK 500,000. |
14.3 |
The DKK 500,000 cap of the CEOs liability set out in clause 14.2 shall not apply in the case of gross negligence or wilful misconduct by the CEO. Furthermore, for the avoidance of doubt, the Company is under no obligation to hold the CEO harmless for any loss incurred by any third party which such third party pursuant to applicable law is entitled to claim from the CEO. |
15 |
Intellectual property rights |
15.1 |
Ownership in and any right of exploitation to inventions, methods, know-how, patents, trademarks, texts, computer programmes, pictures, illustrations, drawings, designs, models, prototypes. formula, graphic images, concepts and other intellectual property rights (jointly referred to as Rights) that the CEO has developed, may develop or may participate in developing (whether alone or jointly with others) during the term of her employment in the course of the rendering of services under this agreement shall be conferred upon the Company without separate remuneration as the CEOs salary and other terms provided for in this Service Agreement constitute due compensation in this respect. The same shall apply to any such Rights that the CEO may develop or participate in developing within one year after the termination of the employment. |
15.2 |
The Rights are conferred upon the Company regardless of whether the Rights fall within the scope of the Companys activities, whether the Rights were achieved outside normal working hours, or whether the Rights were developed at the Companys premises or elsewhere. |
15.3 |
The CEO must immediately inform the Company in the event that Rights have been or can be expected to be fully or partly developed by the CEO. |
15.4 |
The CEO undertakes to provide the Company with every reasonable assistance in protecting, using and improving its Rights, including but not limited to signing all declarations, documents and permits and disclose all such information that the Company may regard as necessary or desirable for the purpose of (i) transferring, registering or obtaining the Rights in the name of the Company, and (ii) ensuring that the Company can obtain patent, utility, design, copyright or trademark protection anywhere in the world. A rejection (explicit or by non-corporation) by the CEO to comply in any material respect with this clause 15.4 shall be considered a material breach of this Service Agreement. |
15.5 |
The transfer to the Company of copyrights in copyright protected material, products, etc. (jointly referred to as the Material) confers upon the Company an exclusive right to use the Material indefinitely in any way and in any form, all over the world and without restrictions. Moreover, the Company is entitled to make changes to the Material and to transfer fully or partly the copyright to others. The Parties have agreed that sections 54 and 55 of the Danish Act on Copyright shall not apply; hence the CEO cannot cancel the transfer of the copyright due to the Companys failure of exploitation, and equally the transfer of the copyright for unspecified kinds of exploitation cannot be terminated. |
6
16 |
Information security |
16.1 |
The CEO is obliged in every respect to observe the Companys general and specific directions on information security, including directions concerning use of e-mail and internet. Failure to observe these directions may have consequences for the CEOs employment. |
16.2 |
To the extent the Board of Directors deems it necessary in consideration of the security or the operations of the Company the CEO hereby consents to registration and reading of the CEOs e-mails and control of the CEOs use of the internet by a representative of the Company. |
17 |
Termination |
17.1 |
The CEOs employment may be terminated by the Company with six months written notice effective to the end of a month and by the CEO with three months written notice effective to the end of a month. |
17.2 |
If the Company or the CEO commits a material breach of the obligations of this Service Agreement, the other party is entitled to terminate the Agreement without notice. |
18 |
Miscellaneous |
18.1 |
The CEO shall inform the Company of the CEOs current private address. |
18.2 |
The CEO is not considered a salaried employee of the Company. Accordingly, the CEO is not covered by the Danish Salaried Employees Act, the Danish Holiday Act or other legislation protecting the interests of employees. |
18.3 |
The Company is in the process of preparing procedures and documents to comply with the Data Protection Regulation which will enter into force in May 2018. In connection with such procedures, all employees of the Company, including the CEO, will receive a separate addendum to their employment agreement concerning the processing of personal data to comply with the Data Protection Regulation. |
7
19 |
Choice of law and venue |
19.1 |
This Service Agreement is governed by and construed in accordance with Danish law. |
19.2 |
Any dispute concerning this Service Agreement shall be settled exclusively by the ordinary Danish courts. |
This Service Agreement is signed in two identical copies, of which each party receives one.
On behalf of the Company: | On behalf of the CEO: | |||
Date: _____ March 2018 | Date: _____ March 2018 | |||
/s/ Peter Hirth | /s/ Mai-Britt Zocca | |||
Peter Hirth, Chairman | Mai-Britt Zocca |
/s/ Claus Asbjarn Anderson |
Claus Asbjarn Anderson, board member |
8
Exhibit 10.15
Addendum to Service Agreement
This addendum to the service agreement dated 21 August 2017 (the Addendum) is entered into between:
IO Biotech ApS
[***]
(the Company)
and
Mai-Britt Zocca
(theCEO)
1 |
Remuneration |
1.1 |
Effective from 1 April 2021, the annual gross salary amounts to DKK 2,400,000. The salary is pay 1/12 monthly in arrears not later than on the last business day of each month. |
2 |
Pension scheme |
2.1 |
In addition to the gross salary, the Company pays a pension contribution corresponding to 10% of the CEOs gross salary, cf. clause 1.1. The CEOs minimum pension contribution constitutes 3% of the CEOs gross salary, cf. clause 1.1 |
3 |
Other terms of employment |
3.1 |
All other terms and conditions of the employment remain unchanged. |
3.2 |
The CEO is to enclose this addendum to the service agreement. Addenda to the service agreement from an integral part of the service agreement. |
Date: | Date: | |||
For and on behalf of the Company: | ||||
/s/ Peter Hirth | /s/ Mai-Britt Zocca | |||
Peter Hirth, Chairman | Mai-Britt Zocca | |||
/s/ Priyanka Belawat | ||||
Priyanka Belawat, Board member |
Exhibit 10.16
Service Agreement
This service agreement is entered into between:
IO Biotech ApS
[***]
(the Company)
and
Eva Ehrnrooth
(the CMO)
1 |
Commencement of employment and title |
1.1 |
With effect from 1 October 2017, the CMO will be employed as Chief Medical Officer (CMO) in the Company on the terms and conditions set forth in this service agreement (the Agreement). |
1.2 |
The CMO reports to CEO Mai-Britt Zocca. |
2 |
The duties of the CMO |
2.1 |
The CMO is in co-operation with the other members of management responsible for the daily management of the Companys medical strategy subject to the instructions and guidelines issued by the CEO and in accordance with the job description, cf. clause 2.4. |
2.2 |
Due to the nature other position, it is the responsibility of the CMO to ensure that her area of business is at all times operated in accordance with the Companys policies and applicable law. |
2.3 |
Due to the nature of her position, the CMO is entitled to sign on behalf of the Company in matters concerning her area of business, to the extent agreed with the CEO. All questions of extraordinary character or major importance to the Company shall be submitted by the CMO to the CEO. |
2.4 |
The CMOs duties and objectives are to be described in a separate document, which constitutes an appendix to this Agreement. |
3 |
Place of work |
3.1 |
The CMOs normal place of work will be at the address of the Company from time to time. The current address of the Company is stated above. The CMO may be required to work at the premises of business partners etc. typically in connection with meetings and the work may involve travelling in Denmark and abroad. |
4 |
Working hours |
4.1 |
The ordinary weekly working hours are 37 hours, excluding lunch break. |
The CMO is obliged to undertake overtime work to a reasonable extent. No separate payment will be made to the CMO in respect of overtime hours, and the CMO is not entitled to take time off in lieu.
5 |
Salary |
5.1 |
The monthly gross base salary is DKK 170,500 payable monthly in arrears on the last working day of each month at the latest. |
6 |
Pension scheme |
6.1 |
The Company has not established a general pension scheme. However, the Company will at the request of the CMO administer payments into a pension scheme established by the CMO. |
6.2 |
The Company is currently in the process of establishing a general pension scheme. Once this scheme is established, the Company will at the request of the CMO be happy to pay part of the agreed base salary, cf. clause 5.1 into such scheme. |
7 |
Bonus |
7.1 |
The CMO will be eligible to bonus. Bonus targets/milestones are determined from year to year by the CEO and notified to the CMO before or at the latest at the beginning of the financial year. The bonus targets/milestones are determined with due consideration to the research strategy of the Company for the year in question and will be set forth in a separate document which constitutes an appendix to this Agreement. Any bonus will be paid to the CMO no later than with the first ordinary payment of salary after the annual report has been approved by the general meeting. Bonus amounts cannot exceed 20% of the annual base salary, cf. clause 5.1. |
7.2 |
The CEO and ultimately the Board of Directors shall discretionarily determine to what extent the bonus targets/milestones have been fulfilled and will if targets/milestones are only partially met prorate the bonus accordingly. If the Board of Directors decides during the bonus year to change the strategy or objectives of the Company, the CEO and ultimately the Board of Directors may redefine the targets/milestones, while reasonably taking into account the remaining time left to achieve such new targets/milestones when assessing to what extent the targets/milestones have been met. |
8 |
Warrants |
8.1 |
Subject to satisfactory performance, the CMO will free of charge receive warrants in the Company in connection with the next round of issuing warrants. The warrants will be granted in accordance with the terms and conditions of the warrant scheme determined at the discretion of the Board of Directors. Exercise of the warrants will be conditional upon the warrants vesting in accordance with the terms of the scheme. The warrants will in total grant the CMO the right to subscribe for 2,766 A-shares in the Company of nominally DKK 1 each against cash payment. The number of A-shares corresponds to 1% of the joint capital of the Company at the time of entering into this Service Agreement (i.e. DKK 276,557.00). |
9 |
Sign-On fee |
9.1 |
The CMO will receive a sign-on fee of gross DKK 186,000 payable immediately after this Service Agreement has been signed by the parties. |
2
10 |
Other benefits and payments |
10.1 |
The Company will provide the CMO with mobile telephone, internet access and a PC. The Company will pay all reasonable expenses in this respect. |
10.2 |
The CMO shall not be allowed to use any telephone connections, cf. clause 10.1 above, for paying e.g. contributions to charitable work or participation in competitions requiring payment of fees. |
10.3 |
If so requested by the Company, the CMO shall return the items listed above no later than on the day on which the CMOs duty to work ceases. At such date, the Company will also cease to pay the costs relating to the mobile telephone and internet access. During any remaining notice period, the CMO will receive a monthly amount corresponding to the applicable tax value of the benefits in question. The CMO has no lien or right of retention on the items. |
10.4 |
The parties agree that the Company will arrange for the CMO to be subject to a health insurance scheme. However, the CMO acknowledges and agrees that such insurance will first need to be established and thus will not apply as of commencement of employment. |
10.5 |
Any tax consequences to the CMO arising out of the above benefits are of no concern to the Company. |
11 |
Pregnancy and childbirth |
11.1 |
The CMO is entitled to absence in connection with pregnancy and childbirth in accordance with applicable Danish law. |
11.2 |
The CMO is entitled to salary, cf. clause 11.3, during absence in connection with pregnancy and childbirth from 4 weeks before the expected childbirth and until 14 weeks after the birth. Moreover, the CMO is entitled to salary, cf. clause 11.3, for up to 13 weeks after the 14th week after the birth. |
11.3 |
The right to salary is contingent upon the Company obtaining maximum reimbursement in the form of maternity benefits and compensation from the applicable maternity scheme and the salary payment cannot exceed the amount that the Company obtains from time to time. |
11.4 |
Notwithstanding the clauses above, the CMO is always entitled to receive half her salary during absence in connection with pregnancy and childbirth from 4 weeks before the expected childbirth and until 14 weeks after the birth. |
12 |
Holidays |
12.1 |
The CMO is entitled to holidays with pay and holiday allowance in accordance with the provisions of the Danish Holiday Act in force from time to time. |
12.2 |
The CMO is moreover entitled to 5 special days off per holiday year. During the first holiday year (1.5.2017-30.4.2018), the number of special days off will be granted proportionately. Each of the special days off is to be taken as a full day off. Any special days off that have not been taken within the holiday year or before expiry of a notice period will lapse without any monetary compensation. The special days off are not governed by the Danish Holiday Act. Holidays under the Danish Holiday Act shall be taken before the special days off |
3
12.3 |
The holiday should generally be taken subject to agreement between the CEO and the CMO or otherwise notified in accordance with the applicable rules in the Danish Holiday Act. However, during a notice period, the Company may give notice to the effect that the main holiday and the remaining part of the holiday are to be taken subject to 1 months written notice. Also, holidays already planned during a notice period must be taken during this period regardless of the duration of the notice period. |
13 |
Sickness |
13.1 |
The CMO is entitled to receive salary during periods of sickness in accordance with the provisions of the Danish Salaried Employees Act in force from time to time. |
13.2 |
If, due to sickness, the CMO is prevented from carrying out work, the CMO is obliged to inform the Company by telephone before commencement of normal working hours. At the request of the Company, the CMO is obliged to document sickness. |
13.3 |
The CMO is entitled to paid leave on childs first sick day. |
14 |
Entertainment and travel expenses |
14.1 |
The CMOs reasonable costs in connection with travel and entertainment in the interest of the Company will be refunded by the Company subject to receipts in accordance with the Companys guidelines in force from time to time. The CMO shall account for travel and entertainment expenses as soon as possible after the expenses have been paid. |
15 |
Other activities or interests and loyalty |
15.1 |
During the period of employment and during a notice period, the CMO is obliged to devote the whole of the CMOs time to the business of the Company. The CMO may therefore neither directly nor indirectly undertake any other professional activity, whether remunerated or not, without obtaining the prior written approval of the CEO. |
15.2 |
During the employment and during a notice period, the CMO is obliged to observe an obligation of loyalty towards the Company. |
16 |
Rules of procedure governing the performance of work |
16.1 |
The Company has established policies governing the performance of the work and attaches great importance to the CMO observing these rules and keeping up to date of any changes. Failure to comply with the Companys policies may have legal consequences for the CMOs employment. |
17 |
Confidentiality and return of material |
17.1 |
The CMO has a duty of strict confidentiality in respect of all information received in connection with the performance of the duties and the CMO shall not be allowed to make any public statements or release without the prior written consent of the CEO. The duty of confidentiality remains in force after end of employment. Failure to observe the duty of confidentiality may have legal consequences for the CMOs employment. |
4
17.2 |
No later than on the day on which the CMOs duty to work ceases, the CMO is obliged to return all items and material that belong to or relate to the activities of the Company. No lien or right of retention may be exercised on items or material belonging to the Company. |
18 |
Combined non-competition and non-solicitation clause |
18.1 |
During the employment and for a period of 6 months after the employment has ended, the CMO: |
(a) |
shall not commence any business or in any way be engaged in any business (as own -er, board member, employee, agent, consultant or otherwise) that directly or indirectly competes with the business conducted by the Company within cancer vaccines targeting immune modulation for the treatment and prevention of cancer at the time the employment ended. |
This non-competition clause applies globally and also covers competing activities on social media, including LinkedIn.
This non-competition clause is entered into as the Company and the CMO agree that the CMO is an exceptionally trusted employee. Given the CMOs duties and position, she will be or come into possession of knowledge or confidential information that can be used to the detriment of the Company by a competing business. This includes knowledge about the Companys diverse pipeline in the field of Immuno Oncology.
This non-competition clause shall lapse if the employment is terminated by the Company without the CMO having given just cause for such termination or if the CMO terminates the employment, and the Companys failure to meet its obligations pro -vides just cause for such termination. In such cases, the CMO is not entitled to receive compensation from the third month, however, the CMO is still entitled to receive the Lump Sum, cf. below, if the CMO has been employed for at least 3 months when then employment ends.
(b) |
shall not, whether directly or indirectly, have any business contact with or be employed by a business or person that was a customer or business partner of the Company and with whom the CMO during the 12 months preceding the date of termination has had business relations. Indirect business contact shall be understood as e.g. the CMOs employment with a business that has business contact with any of the customers comprised by this non-solicitation clause, regardless of whether it has been agreed with the new employer that the CMO is not to serve the customers in question. |
This non-solicitation clause also covers direct and indirect business contact on social media, including LinkedIn.
At the latest in connection with the termination of employment by either party, the CMO will receive a list of the customers governed by this non-solicitation clause. Upon request, the CMO is to draft such list. The CMO is obliged to contribute loyally towards ensuring that the list of customers concerned reflects the customers with whom the CMO has had business relations.
5
18.2 |
This combined non-competition and non-solicitation clause is enforceable only when the CMO has been employed continuously for 6 months. |
18.3 |
During the period after the employment has ended, in which this combined non -competition and non-solicitation clause remains in force, the CMO will receive compensation corresponding to 60% of the remuneration at the time the employment ended. Compensation for the first 2 months is paid as a lump sum at the end of employment, regardless of whether the CMO obtains other suitable employment (the Lump Sum). From the third month after the employment has ended, compensation will be paid monthly in arrears during the remaining part of the period. |
18.4 |
If the CMO commences independent business or obtains other suitable employment, the CMO is from the third month after the employment has ended entitled only to compensation corresponding to 24% of the remuneration at the time the employment ended. |
18.5 |
The CMO is obliged to actively apply for other suitable employment. If the CMO fails to meet the CMOs duty to mitigate losses, the right to compensation will lapse. However, the CMO is entitled to the Lump Sum if the CMO has been employed for at least 3 months when the employment ends. |
18.6 |
During the period in which this combined non-competition and non-solicitation clause remains in force, the CMO is obliged to inform the Company in writing if the CMO commences independent business and/or obtains new employment. Failure to do so will be regarded as a material breach of this agreement. |
18.7 |
In the event of summary dismissal with just cause, the CMOs right to compensation lapses, including the Lump Sum. |
18.8 |
Breach of the non-competition and/or non-solicitation clause may be sanctioned by injunction. Further, the CMO will be obliged to pay damages and an agreed penalty corresponding to 3 months gross salary for each occurrence of the breach. If the breach concerns an ongoing situation that is in breach of the non-competition and/or non-solicitation clause, one breach shall be deemed to have occurred for each calendar month or part thereof in which the breach occurs. The employees payment of the agreed penalty and/or damages does not render the non-competition and/or non-solicitation clause ineffective and does not prevent the Company from seeking other remedies. |
18.9 |
The Company may at any time terminate this combined non-competition and non-solicitation clause by giving 1 months written notice to expire at the end of a month. In such case, the CMO may be entitled to receive the Lump Sum. |
6
19 |
Intellectual property rights |
19.1 |
All intellectual property rights or assets that the CMO may develop or contribute in developing belong to the Company. The CMO is not entitled to any separate remuneration in this respect. |
19.2 |
The CMO must sign all necessary declarations and permissions to ensure transfer, registration etc. of the rights in question. |
19.3 |
The Danish Act on Employees Inventions applies to inventions and utility models that may be patented or registered in Denmark. However, section 7(1) of the Act is deviated from to the effect that the Company is regarded as having given the CMO notice of its intention to acquire the invention or utility model unless the Company has given the CMO notice to the contrary within 1 month after having received the notice provided for in section 6 of the Act. Only if the CMO has received such written notice, the CMO is entitled to dispose of the invention or utility model and disclose information hereof to third parties. |
20 |
Termination |
20.1 |
The CMO is not subject to a probationary period. |
20.2 |
Notice of termination shall be made in accordance with the provisions of the Danish Salaried Employees Act in force from time to time. However, the notice periods provided for in the Danish Salaried Employees Act are mutually extended by 1 month. Further, it is agreed that the notice to be given by the Company shall from the beginning of the employment be at least 6 months to the end of a month. |
20.3 |
Notice of termination must be given in writing not later than on the last day of the month at the expiry of which the notice period commences. |
20.4 |
If, during a period of 12 consecutive months, the CMO has received salary during sickness for a total period of 120 days, the Company may terminate the employment giving 2 months written notice to expire at the end of a month. |
21 |
Tax consequences |
21.1 |
Any tax consequences for the CMO arising out of this Agreement shall be of no concern to the Company. |
22 |
Venue and governing law |
22.1 |
The employment is subject to Danish law and any dispute between the parties shall be settled at the Companys venue. |
23 |
Other issues |
23.1 |
With due respect of the secrecy of the mails and to the extent that it is deemed necessary in consideration to the safety or operations of the Company, the Company will register and read the CMOs business related (i.e. not private) e-mails and monitor the CMOs use of the internet. |
23.2 |
The CMO must keep the Company informed of her current address. |
7
23.3 |
The Danish Salaried Employees Act applies to the employment. The employment is not subject to any collective bargaining agreements. |
23.4 |
The CMO is hereby informed that the Company may transfer all sensitive and non -sensitive data concerning the employment to group companies and third parties, both within and outside the EU in case such transfer serves just cause, e.g. because the transfer takes place in connection with a third partys potential investment in the Company. Upon transfer of such data, a duty of confidentiality will be imposed upon the recipient. |
This Agreement is signed in duplicate. The parties each receive one original copy.
Date: | Date: |
For and on behalf of the Company:
/s/ Mai-Britt Zocca
|
/s/ Eva Ehrnrooth
|
|||
Mai-Britt Zocca, CEO | Eva Ehrnrooth |
8
Exhibit 10.17
Addendum to Service Agreement
This addendum to the service agreement dated 21 August 2017 (the Addendum) is entered into between:
IO Biotech ApS
[***]
(the Company)
and
Eva Ehrnrooth
(the CMO)
1 |
Remuneration |
1.1 |
Effective from 1 April 2021, the monthly gross salary is DKK 187,500 payable monthly in arrears on the last working day of each month at the latest. |
2 |
Pension scheme |
2.1 |
The CMO will be part of the Companys general pension scheme in force from time to time. In addition to the gross salary, the Company pays a pension contribution corresponding to 10% of the CMOs gross salary, cf. clause 1.1. The CMOs minimum pension contribution constitutes 3% of the CMOs gross salary, cf. clause 1.1 |
3 |
Other terms of employment |
3.1 |
All other terms and conditions of the employment remain unchanged. |
3.2 |
The CMO is to enclose this addendum to the service agreement. Addenda to the service agreement from an integral part of the service agreement. |
Date: | Date: |
For and on behalf of the Company:
/s/ Mai-Britt Zocca
|
/s/ Eva Ehrnrooth
|
|||
Mai-Britt Zocca, CEO | Eva Ehrnrooth |
Exhibit 21.1
Subsidiaries of the Registrant
Legal Name of Subsidiary |
Jurisdiction of Organization |
|
IO Biotech ApS | Denmark | |
IO Bio US, Inc. | Delaware, United States | |
IO Biotech Limited | England and Wales |