File No. 000-54735

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

AMENDMENT NO. 3

To

FORM 10

 

 

GENERAL FORM FOR REGISTRATION OF SECURITIES

Pursuant to Section 12(b) or (g) of the Securities Exchange Act of 1934

 

 

KALOBIOS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   77-0557236

(State or other jurisdiction

of incorporation)

 

(IRS Employer

Identification No.)

 

260 East Grand Avenue,

South San Francisco, CA

  94080
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (650) 243-3100

Securities to be registered pursuant to Section 12(g) of the Act:

Common Stock, $.001 par value

(Title of Class)

 

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   ¨   (Do not check if a smaller reporting company)    Smaller reporting company   x

We are an “emerging growth company” as defined under the federal securities laws. For implications of our status as an emerging growth company, please see “Risk Factors” in Item 1A and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 2 of this registration statement.

 

 

 


EXPLANATORY NOTE

This Amendment No. 3 to the Registration Statement on Form 10 (File No. 000-54735) is being filed solely to file exhibits. No changes have been made to the other sections of the Registration Statement. Accordingly, they have been omitted.

 

2


SIGNATURES

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    KALOBIOS PHARMACEUTICALS, INC.
September 12 , 2012     By:   /s/ David Pritchard
       

Name:  David Pritchard

Title:     Chief Executive Officer

*Print name and title of the signing officer under his signature.

 

3


EXHIBIT INDEX

 

Exhibit

 

Description

3.1+   Certificate of Incorporation of the Registrant
3.2+   Bylaws of the Registrant
4.1+   Specimen of Stock Certificate evidencing shares of Common Stock
4.2+   Specimen of Stock Certificate evidencing shares of Series B-1 Preferred Stock
4.3+   Specimen of Stock Certificate evidencing shares of Series B-2 Preferred Stock
4.4+   Specimen of Stock Certificate evidencing shares of C Preferred Stock
4.5+   Specimen of Stock Certificate evidencing shares of D Preferred Stock
4.6+   Specimen of Stock Certificate evidencing shares of E Preferred Stock
4.7   Amended and Restated Investors’ Rights Agreement, dated May 2, 2012, by and among the Registrant and the other parties thereto
10.1+   2001 Stock Plan
10.2+   Form of Notice of Grant and Stock Option Agreement under the 2001 Stock Plan
10.3+   Form of Notice of Grant and Stock Option Agreement under the 2001 Stock Plan (Outside Directors)
10.4+   Form of Notice of Grant and Stock Option Agreement under the 2001 Stock Plan (Executive Grants)
10.5+   Form of Notice of Grant and Stock Option Agreement under the 2001 Stock Plan (Senior Management)
10.6+   Form of Notice of Exercise under the 2001 Stock Plan (Early Exercise)
10.7+   2012 Equity Incentive Plan, effective upon effectiveness of this Registration Statement
10.8+   Form of Notice of Grant and Stock Option Agreement under the 2012 Equity Incentive Plan
10.9   Amended and Restated Voting Agreement, dated May 2, 2012, by and among the Registrant and the other parties thereto
10.10   Amended and Restated Right of First Refusal and Co-Sale Agreement, dated May 2, 2012, by and among the Registrant and the other parties thereto
10.11+   Form of Director and Officer Indemnification Agreement
10.12*   Development, Commercialization, Collaboration and License Agreement, dated January 8, 2010, by and between the Registrant and Sanofi Pasteur S.A.
10.13*+   Development and License Agreement, dated May 11, 2004, by and between the Registrant and the Ludwig Institute for Cancer Research
10.14*+   License Agreement, dated April 7, 2006, by and between the Registrant and the Ludwig Institute for Cancer Research
10.15*+   Exclusive License Agreement, dated April 6, 2004, by and between the Registrant and The Regents of the University of California
10.16*   Non-Exclusive License Agreement, dated October 15, 2010, by and between the Registrant, BioWa, Inc. and Lonza Sales AG
10.17*+   License Agreement, dated March 16, 2007, by and between the Registrant and Novartis International Pharmaceutical Ltd.
10.18+   Employment Offer Letter, dated August 15, 2006, by and between the Registrant and David Pritchard
10.19+   Employment Offer Letter, dated February 1, 2011, by and between the Registrant and Jonathan Leff
10.20+   Employment Offer Letter, dated January 8, 2004, by and between the Registrant and Geoffrey Yarranton
10.21+   Letter Agreement, dated December 18, 2008, by and between the Registrant and David Pritchard
10.22+   Letter Agreement, dated April 6, 2011, by and between the Registrant and Jonathan Leff

 

4


Exhibit

  

Description

10.23+    Letter Agreement, dated April 6, 2006, by and between the Registrant and Geoffrey Yarranton
10.24+    Letter Agreement, dated April 20, 2007, by and between the Registrant and Geoffrey Yarranton
10.25+    Letter Agreement, dated December 18, 2008, by and between the Registrant and Geoffrey Yarranton
10.26+    Lease, dated January 19, 2011, by and between Britannia Pointe Grand Limited Partnership and the Registrant
10.27+    Sublease Agreement, dated January 19, 2011, by and between the Registrant and Alios Biopharma, Inc.
10.28+    First Amendment to Sublease, dated August 1, 2011, by and between the Registrant and Alios Biopharma, Inc.
10.29+    Second Amendment to Sublease, dated December 13, 2011, by and between the Registrant and Alios Biopharma, Inc.
10.30+    Sublease Agreement, dated March 1, 2012, by and between the Registrant and Compugen, Inc.
10.31+    Employment Offer Letter, dated April 23, 2012, by and between the Registrant and Jeffrey H. Cooper
10.32+    Letter Agreement, dated July 5, 2012, by and between the Registrant and Jeffrey H. Cooper
10.33+    Employment Offer Letter, dated April 18, 2012, by and between the Registrant and Nestor A. Molfino
10.34+    Letter Agreement, dated May 29, 2012, by and between the Registrant and Nestor Molfino

 

* Confidential Treatment Requested
+ Previously filed

 

5

Exhibit 4.7

KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED

INVESTORS’ RIGHTS AGREEMENT

MAY 2, 2012


TABLE OF CONTENTS

 

     Page  

1. Registration Rights

     2   

1.1 Definitions

     2   

1.2 Request for Registration

     3   

1.3 Company Registration

     5   

1.4 Form S-3 Registration

     7   

1.5 Obligations of the Company

     8   

1.6 Information from Holder

     10   

1.7 Expenses of Registration

     10   

1.8 Delay of Registration

     10   

1.9 Indemnification

     10   

1.10 Reports Under Securities Exchange Act of 1934

     13   

1.11 Assignment of Registration Rights

     13   

1.12 “Market Stand-Off” Agreement

     14   

1.13 Termination of Registration Rights

     14   

1.14 Limitations on Subsequent Registration Rights

     14   

2. Covenants of the Company

     15   

2.1 Delivery of Financial Statements

     15   

2.2 Inspection

     16   

2.3 Right of First Offer

     16   

2.4 Employee Agreements

     18   

2.5 Key-Man Insurance

     18   

2.6 Directors and Officers Insurance

     18   

2.7 Other Covenants

     18   

2.8 Termination of Certain Covenants

     19   

2.9 Fidelity Covenants

     19   

3. Miscellaneous

     20   

3.1 Successors and Assigns

     20   

3.2 Governing Law

     20   

3.3 Counterparts

     21   

3.4 Titles and Subtitles

     21   

3.5 Notices

     21   

3.6 Expenses

     21   

3.7 Entire Agreement: Amendments and Waivers

     21   

3.8 Severability

     21   

3.9 Aggregation of Stock

     22   

3.10 Directors’ Expenses

     22   

3.11 Additional Parties

     22   

3.12 Termination of Prior Agreement

     22   

3.13 Massachusetts Business Trust

     22   

 

i


AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT

This AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT is made as of May 2, 2012, by and among KaloBios Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and the investors listed on Schedule A hereto, each of which is herein referred to as an “ Investor .”

RECITALS

WHEREAS, certain of the Investors (the “ Existing Investors ”) hold (i) shares of the Company’s Common Stock and/or securities exercisable therefor, (ii) shares of Series A Preferred Stock and/or shares of Common Stock issued upon conversion thereof (the “ Series A Preferred Stock ”), (iii) shares of Series B-1 Preferred Stock and/or shares of Common Stock issued upon conversion thereof (the “ Series B-1 Preferred Stock ”), (iv) shares of Series B-2 Preferred Stock and/or shares of Common Stock issued upon conversion thereof (the “ Series B-2 Preferred Stock ”), (v) shares of Series C Preferred Stock and/or shares of Common Stock issued upon conversion thereof (the “ Series C Preferred Stock ”) and (vi) shares of Series D Preferred Stock and/or shares of Common Stock issued upon conversion thereof (the “ Series D Preferred Stock ”) and possess registration rights, information rights, rights of first offer and other rights pursuant to an Amended and Restated Investors’ Rights Agreement dated as of September 22, 2008, by and among the Company and such Existing Investors (the “ Prior Agreement ”);

WHEREAS, the Prior Agreement may be amended, and any provision therein waived, with the consent of the Company and the holders of sixty-percent (60%) of the Registrable Securities (as such term is defined in the Prior Agreement);

WHEREAS, the Existing Investors as holders of sixty-percent (60%) of the Registrable Securities (as such term is defined in the Prior Agreement) of the Company desire to terminate the Prior Agreement and to accept the rights created pursuant hereto in lieu of the rights granted to them under the Prior Agreement; and

WHEREAS, certain Investors are parties to the Series E Preferred Stock Purchase Agreement of even date herewith by and among the Company and certain of the Investors (the “ Series E Agreement ”), which provides that as a condition to the closing of the sale of the Series E Preferred Stock (the “ Series E Preferred Stock ” and collectively with the Series A Preferred Stock, the Series B-1 Preferred Stock, Series B-2 Preferred Stock, the Series C Preferred Stock and the Series D Preferred Stock, the “ Preferred Stock ”), this Agreement must be executed and delivered by such Investors, Existing Investors holding sixty percent (60%) of the Registrable Securities (as such term is defined in the Prior Agreement) of the Company, and the Company.

NOW, THEREFORE, in consideration of the mutual promises and covenants set forth herein, the Existing Investors hereby agree that the Prior Agreement shall be superseded and replaced in its entirety by this Agreement, and the parties hereto further agree as follows:


1. Registration Rights . The Company covenants and agrees as follows:

1.1 Definitions . For purposes of this Section 1:

(a) The term “ Act ” means the Securities Act of 1933, as amended.

(b) The term “ Form S-3 ” means such form under the Act as in effect on the date hereof or any registration form under the Act subsequently adopted by the SEC that permits inclusion or incorporation of substantial information by reference to other documents filed by the Company with the SEC.

(c) The term “ Holder ” means any person owning or having the right to acquire Registrable Securities or any assignee thereof in accordance with Section 1.11 hereof.

(d) The term “ Initial Public Offering ” means the Company’s first firm commitment underwritten public offering of its Common Stock under the Act (other than pursuant to a Re-Sale Form S-1 effected pursuant to Section 1.3(c) hereto).

(e) The term “ New Re-Sale Registration Statement ” shall have the meaning set forth in Section 1.3(c) hereto.

(f) The term “ 1934 Act ” means the Securities Exchange Act of 1934, as amended.

(g) The term “ Original Re-Sale Form S-1 ” shall have the meaning set forth in Section 1.3(c) hereto.

(h) The term “ OTC Quotation System ” means the inter-dealer quotation system known as the OTC Bulletin Board.

(i) The term “ OTC Trading Date ” means the first date when the Common Stock begins being quoted and/or traded on an OTC Quotation System.

(j) The term “ PIPE Offering ” means a private placement offering by the Company of shares of its Common Stock or Preferred Stock, in each case, at a price per share not less than $3.40, primarily for working capital purposes that is consummated in connection with which the Company agrees to use its reasonable best efforts to file, in a defined period following such offering, a resale registration statement registering such shares.

(k) The term “ register ,” “ registered ,” and “ registration ” refer to a registration effected by preparing and filing a registration statement or similar document in compliance with the Act, and the declaration or ordering of effectiveness of such registration statement or document.

 

2


(l) The term “ Registrable Securities ” means (i) an aggregate of 564,915 shares of Common Stock held by 5AM Ventures LLC and 5AM Co-Investors LLC, (ii) Common Stock issuable or issued upon conversion of the Preferred Stock, (iii) shares of Common Stock issuable or issued upon exercise of warrants outstanding as of the date hereof and (iv) Common Stock of the Company issued as (or issuable upon the conversion or exercise of any warrant, right or other security that is issued as) a dividend or other distribution with respect to, or in exchange for, or in replacement of, the shares referenced in (i), (ii) or (iii) above, excluding in all cases, however, any Registrable Securities sold by a person in a transaction in which his rights under this Section 1 are not assigned.

(m) The number of shares of “Registrable Securities” outstanding shall be determined by the number of shares of Common Stock outstanding that are, and the number of shares of Common Stock issuable pursuant to then exercisable or convertible securities that are, Registrable Securities.

(n) The term “ Re-Sale Form S-1 ” shall have the meaning set forth in Section 1.3(c) hereto.

(o) The term “ Re-Sale Shares ” shall have the meaning set forth in Section 1.3(c) hereto.

(p) The term “ SEC ” shall mean the Securities and Exchange Commission.

(q) The term “SEC Rule 145” means Rule 145 promulgated by the SEC under the Act.

1.2 Request for Registration .

(a) Subject to the conditions of this Section 1.2, if the Company shall receive at any time after the earliest of (i) one (1) year after the date of this Agreement, (ii) one hundred eighty (180) days after the effective date of the Initial Public Offering or (iii) one (1) year following the effectiveness of the Company’s first Form 10 registration statement filed with the SEC pursuant to the Exchange Act, a written request from the Holders of twenty-five percent (25%) or more of the Registrable Securities then outstanding (the “ Initiating Holders ”) that the Company file a registration statement under the Act covering the registration of (i) at least 50% of the then outstanding Registrable Securities or (ii) Registrable Securities with an anticipated aggregate offering price of at least $10,000,000 (net of underwriting discounts and commissions), then the Company shall, within twenty (20) days of the receipt thereof, give written notice of such request to all Holders, and subject to the limitations of this Section 1.2, use best efforts to effect, as soon as practicable, the registration under the Act of all Registrable Securities that the Holders request to be registered in a written request received by the Company within twenty (20) days of the mailing of the Company’s notice pursuant to this Section 1.2(a).

(b) If the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to this Section 1.2 and the Company shall include such information in the written notice referred to in Section 1.2(a). In such event the right of any Holder to include its Registrable Securities in such registration shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s

 

3


Registrable Securities in the underwriting (unless otherwise mutually agreed by a majority in interest of the Initiating Holders and such Holder) to the extent provided herein. All Holders proposing to distribute their securities through such underwriting shall enter into an underwriting agreement in customary form with the underwriter or underwriters selected for such underwriting by the Company (which underwriter or underwriters shall be reasonably acceptable to a majority in interest of the Initiating Holders). Notwithstanding any other provision of this Section 1.2, if the underwriter advises the Company that marketing factors require a limitation of the number of securities underwritten (including Registrable Securities), then the Company shall so advise all Holders of Registrable Securities that would otherwise be underwritten pursuant hereto, and the number of shares that may be included in the underwriting shall be allocated to the Holders of such Registrable Securities on a pro rata basis based on the number of Registrable Securities held by all such Holders (including the Initiating Holders). In no event shall any Registrable Securities be excluded from such underwriting unless all other securities are first excluded. Any Registrable Securities excluded or withdrawn from such underwriting shall be withdrawn from the registration.

(c) The Company shall not be required to effect a registration pursuant to this Section 1.2:

(i) in any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, unless the Company is already subject to service in such jurisdiction and except as may be required under the Act; or

(ii) after the Company has effected two (2) registrations pursuant to this Section 1.2 covering all shares requested to be registered by the Initiating Holders or Holders joining such request (assuming no shares have been excluded from the offering by the decision of the Company or the underwriter or underwriters), and such registrations have been declared or ordered effective; or

(iii) during the period starting with the date sixty (60) days prior to the Company’s good faith estimate of the date of the filing of, and ending on a date one hundred eighty (180) days following the effective date of, a Company-initiated registration subject to Section 1.3 below, provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective; or

(iv) if the Initiating Holders propose to dispose of Registrable Securities that may be registered on Form S-3 pursuant to Section 1.4 hereof; or

(v) if the Company shall furnish to Holders requesting a registration statement pursuant to this Section 1.2, a certificate signed by the Company’s Chief Executive Officer or Chairman of the Board stating that in the good faith judgment of the Board of Directors of the Company, it would be seriously detrimental to the Company and its stockholders for such registration statement to be effected at such time, in which event the Company shall have the right to defer such filing for a period of not more than ninety (90) days after receipt of the request of the Initiating Holders, provided that such right to delay a request shall be exercised by the Company not more than once in any twelve (12)-month period and provided further that the Company shall not register any securities for the account of itself or any other stockholder during such ninety (90) day period (other than a registration relating solely to the sale of securities of participants in a Company stock plan, or a registration relating to a corporate reorganization or transaction under Rule 145 of the Act).

 

4


1.3 Company Registration .

(a) If (but without any obligation to do so) the Company proposes to register (including for this purpose a registration effected by the Company for stockholders other than the Holders) any of its stock or other securities under the Act in connection with the public offering of such securities (other than a registration relating solely to the sale of securities to participants in a Company stock plan, a registration relating to a corporate reorganization or other transaction under Rule 145 of the Act, a registration on any form that does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities, a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered, or a registration on a Re-Sale Form S-1), the Company shall, at such time, promptly give each Holder written notice of such registration. Upon the written request of each Holder given within twenty (20) days after mailing of such notice by the Company in accordance with Section 3.5, the Company shall, subject to the provisions of Section 1.3(c), use best efforts to cause to be registered under the Act all of the Registrable Securities that each such Holder has requested to be registered. If a Holder decides not to include all of its Registrable Securities in any registration statement thereafter filed by the Company, such Holder shall nevertheless continue to have the right to include any Registrable Securities in any subsequent registration statements as may be filed by the Company with respect to offerings of its securities, all upon the terms and conditions set forth herein.

(b) Right to Terminate Registration . The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 1.3 prior to the effectiveness of such registration whether or not any Holder has elected to include securities in such registration. The expenses of such withdrawn registration shall be borne by the Company in accordance with Section 1.7 hereof.

(c) Initial Re-Sale Registration . Upon the effectiveness of the Company’s first Form 10 registration statement filed with the SEC pursuant to the Exchange Act, and in addition to the registration rights set forth above, the Company will use reasonable best efforts, subject to applicable rules and regulations, to file a registration statement on Form S-1 covering the resale (the “ Original Re-Sale Form S-1 ”) of the shares of Common Stock issued or issuable upon conversion of the shares of Preferred Stock together with any shares of Common Stock or Preferred Stock issued and sold in the PIPE Offering (collectively, the “ Re-Sale Shares ”). In the event the SEC informs the Company that all of the Re-Sale Shares cannot, as a result of the application of SEC Rule 415, be registered for sale in a secondary offering in a single registration statement and/or that certain of the selling stockholders would be deemed to be statutory underwriters, the Company agrees to promptly (i) inform each of the holders of Re-Sale Shares thereof, (ii) use its reasonable best efforts to file amendments to the Original Re-Sale Form S-1 as required by the SEC and/or (iii) withdraw the Original Re-Sale Form S-1 and file a new registration statement on Form S-1 or such other form available for registration of the Re-Sale Shares as a secondary offering (the “ New Re-Sale Registration Statement ”), in either case covering the maximum number of Re-Sale Shares permitted to be registered by the SEC and

 

5


avoid the selling stockholders being deemed to be statutory underwriters; provided , however , that prior to such amendment or New Re-Sale Registration Statement, the Company shall be obligated to use its reasonable best efforts to advocate with the SEC for the registration of all of the Re-Sale Shares and against the selling stockholders being deemed statutory underwriters in accordance with SEC Guidance, including without limitation, the Compliance and Disclosure Interpretations, “Securities Act Rules” No. 612.09, and the Securities Act. In the event the Company amends the Original Re-Sale Form S-1 or files a New Re-Sale Registration Statement, as the case may be, the Company will use its reasonable best efforts to file with the SEC, as promptly as allowed by the SEC, SEC Guidance or the Securities Act, on one or more registration statements, those Re-Sale Shares not included in the Original Re-Sale Form S-1 as amended or the New Re-Sale Registration Statement. The number of Re-Sale Shares that may be included in each such registration statement shall be allocated among the holders thereof in proportion (as nearly as practicable) to the number of Re-Sale Shares owned by each holder or in such other proportion as is necessary to avoid the selling stockholders being deemed to be statutory underwriters, which reductions shall be applied to the holders on a pro rata basis based on the total number of Re-Sale Shares held by such holders. In addition, the Company shall use its reasonable best efforts to file, within thirty (30) days of its becoming eligible to do so, a post-effective amendment to Form S-1 on Form S-3 registration statement covering the Re-Sale Shares. The Company shall use its reasonable best efforts to maintain the continuous effectiveness of such registration statement(s) (including, without limitation, as necessary by filing post-effective amendment(s) if required by the filing of a periodic report on Form 10-K, 10-Q or 8-K), provided that Rule 415, or any successor rule under the Act, permits an offering on a continuous or delayed basis, and provided further that, in the case of a Form S-3 registration statement, applicable rules under the Act governing the obligation to file a post-effective amendment permit, in lieu of filing a post-effective amendment which (I) includes any prospectus required by Section 10(a)(3) of the Act or (II) reflects facts or events representing a material or fundamental change in the information set forth in the registration statement, the incorporation by reference of information required to be included in (I) and (II) above to be contained in periodic reports filed pursuant to Section 13 or 15(d) of the 1934 Act in the registration statement, until such time as all Re-Sale Shares have been sold (except as otherwise provided in Section 1.13 ). For purposes of this Agreement, “ Re-Sale Form S-1 ” shall mean any registration statement filed in accordance with this Section 1.3(c) , including the Original Re-Sale Form S-1 and the New Re-Sale Registration Statement.

The Company shall use its reasonable best efforts to cause its Common Stock, including all such Re-Sale Shares, (i) to be quoted on an OTC Quotation System as soon as practicable after the Re-Sale Form S-1 is declared effective by the SEC and (ii) if otherwise eligible pursuant to applicable listing requirements, to be listed on a national securities exchange (including, for example, the New York Stock Exchange, the NASDAQ Capital Markets and the NASDAQ Global Market) as soon as practicable following the Company’s acceptance for quotation on an OTC Quotation System.

(d) Underwriting Requirements . In connection with any offering involving an underwriting of shares of the Company’s capital stock, the Company shall not be required under this Section 1.3 to include any of the Holders’ securities in such underwriting unless they accept the terms of the underwriting as agreed upon between the Company and the underwriters selected by it (or by other persons entitled to select the

 

6


underwriters) and enter into an underwriting agreement in customary form with an underwriter or underwriters selected by the Company, and then only in such quantity as the underwriters determine in their sole discretion will not jeopardize the success of the offering by the Company. If the total amount of securities, including Registrable Securities, requested by stockholders to be included in such offering exceeds the amount of securities sold other than by the Company that the underwriters determine in their sole discretion is compatible with the success of the offering, then the Company shall be required to include in the offering only that number of such securities, including Registrable Securities, that the underwriters determine in their sole discretion will not jeopardize the success of the offering. In no event shall any Registrable Securities be excluded from such offering unless all other stockholders’ securities have been first excluded. In the event that the underwriters determine that less than all of the Registrable Securities requested to be registered can be included in such offering, then the Registrable Securities that are included in such offering shall be apportioned pro rata among the selling Holders based on the number of Registrable Securities held by all selling Holders or in such other proportions as shall mutually be agreed to by all such selling Holders. Notwithstanding the foregoing, in no event shall the amount of securities of the selling Holders included in the offering be reduced below thirty percent (30%) of the total amount of securities included in such offering, unless such offering is the Initial Public Offering of the Company’s securities, in which case the selling Holders may be excluded if the underwriters make the determination described above and no other stockholder’s securities are included in such offering. For purposes of the preceding parenthetical concerning apportionment, for any selling stockholder that is a Holder of Registrable Securities and that is a partnership or corporation, the partners, retired partners, affiliates, and stockholders of such Holder, or the estates and family members of any such partners and retired partners and any trusts for the benefit of any of the foregoing persons shall be deemed to be a single “selling Holder,” and any pro rata reduction with respect to such “selling Holder” shall be based upon the aggregate amount of Registrable Securities owned by all such related entities and individuals.

1.4 Form S-3 Registration . After its Initial Public Offering, the Company shall use its best efforts to qualify for registration on Form S-3 or any comparable or successor form or forms. In case the Company shall receive from the Holders of Registrable Securities a written request or requests that the Company effect a registration on Form S-3 and any related qualification or compliance with respect to all or a part of the Registrable Securities owned by such Holder or Holders, the Company shall:

(a) promptly give written notice of the proposed registration, and any related qualification or compliance, to all other Holders; and

(b) use best efforts to effect, as soon as practicable, such registration and all such qualifications and compliances as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Holders’ Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any other Holders joining in such request as are specified in a written request given within fifteen (15) days after receipt of such written notice from the Company, provided, however, that the Company shall not be obligated to effect any such registration, qualification or compliance, pursuant to this section 1.4:

 

7


(i) if Form S-3 is not available for such offering by the Holders;

(ii) if the Holders, together with the holders of any other securities of the Company entitled to inclusion in such registration, propose to sell Registrable Securities and such other securities (if any) at an aggregate price to the public (net of any underwriters’ discounts or commissions) of less than $1,000,000;

(iii) if the Company shall furnish to the Holders a certificate signed by the Chief Executive Officer or Chairman of the Board of the Company stating that in the good faith judgment of the Board of Directors of the Company, it would be seriously detrimental to the Company and its stockholders for such Form S-3 Registration to be effected at such time, in which event the Company shall have the right to defer the filing of the Form S-3 registration statement for a period of not more than ninety (90) days after receipt of the request of the Holder or Holders under this Section 1.4; provided, however, that the Company shall not utilize this right more than once in any twelve month period; or

(iv) in any particular jurisdiction in which the Company would be required to qualify to do business or to execute a general consent to service of process in effecting such registration, qualification or compliance.

(c) Subject to the foregoing, the Company shall file a registration statement covering the Registrable Securities and other securities so requested to be registered as soon as practicable after receipt of the request or requests of the Holders. Registrations effected pursuant to this Section 1.4 shall not be counted as requests for registration effected pursuant to Sections 1.2.

1.5 Obligations of the Company . Whenever required under this Section 1 to effect the registration of any Registrable Securities, the Company will keep each Holder advised in writing as to the initiation of such registration and as to the completion thereof, and the Company shall, as expeditiously as reasonably possible:

(a) prepare and file with the SEC a registration statement with respect to such Registrable Securities and use all best efforts to cause such registration statement to become effective, and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, except as with respect to a Re-Sale Form S-1 (which shall be subject to Section 1.3(c)), keep such registration statement effective for a period of up to one hundred twenty (120) days; provided, however, that (i) such 120-day period shall be extended for a period of time equal to the period the Holder refrains from selling any securities included in such registration at the request of an underwriter of Common Stock (or other securities) of the Company; and (ii) in the case of any registration of Registrable Securities on Form S-3 which are intended to be offered on a continuous or delayed basis, such 120-day period shall be extended, if necessary, to keep the registration statement effective until all such Registrable Securities are sold, provided that Rule 415, or any successor rule under the Act, permits an offering on a continuous or delayed basis, and provided further that applicable rules under the Act governing the obligation to file a post-effective amendment permit, in lieu of filing a post-effective amendment which (I) includes any prospectus required by Section 10(a)(3) of the Act or (II) reflects facts or events representing a material or fundamental change in the information set forth in the registration statement, the incorporation by reference of information required to be included in (I) and (II) above to be contained in periodic reports filed pursuant to Section 13 or 15(d) of the 1934 Act in the registration statement.

 

8


(b) prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection with such registration statement as may be necessary to comply with the provisions of the Act with respect to the disposition of all securities covered by such registration statement;

(c) furnish to the Holders participating in such registration such numbers of copies of a prospectus, including a preliminary prospectus, in conformity with the requirements of the Act, and such other documents as they may reasonably request in order to facilitate the disposition of Registrable Securities owned by them;

(d) use all best efforts to register and qualify the securities covered by such registration statement under such other securities or Blue Sky laws of such jurisdictions as shall be reasonably requested by the Holders, provided that the Company shall not be required in connection therewith or as a condition thereto to qualify to do business or to file a general consent to service of process in any such states or jurisdictions unless the Company is already subject to service in such jurisdiction and except as may be required by the Act;

(e) in the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the managing underwriter of such offering;

(f) notify each Holder of Registrable Securities covered by such registration statement at any time when a prospectus relating thereto is required to be delivered under the Act or the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing and at the request of any such Holder, prepare and furnish to such Holder a reasonable number of copies of a supplement to or an amendment of such prospectus as may be necessary so that, as thereafter delivered to the purchasers of such shares, such prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading or incomplete in the light of the circumstances then existing;

(g) cause all such Registrable Securities registered pursuant hereunder to be listed on a national exchange or trading system and on each securities exchange and trading system on which similar securities issued by the Company are then listed;

(h) provide a transfer agent and registrar for all Registrable Securities registered pursuant hereunder and a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration; and

(i) in the event of any underwritten public offering, cooperate with the selling Holders, the underwriters participating in the offering and their counsel in any due diligence investigation reasonably requested by the selling Holders or the underwriters in connection therewith, and participate, to the extent reasonably requested by the managing underwriter for the offering or the selling Holders, in efforts to sell the Registrable Securities under the offering (including, without limitation, participating in “roadshow” meetings with prospective investors) that would be customary for underwritten primary offerings of a comparable amount of equity securities by the Company.

 

9


1.6 Information from Holder . It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 1 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as shall be required to effect the registration of such Holder’s Registrable Securities.

1.7 Expenses of Registration . All expenses other than underwriting discounts and commissions incurred in connection with registrations, filings or qualifications pursuant to Sections 1.2, 1.3 and 1.4, including (without limitation) all registration, filing and qualification fees, printers’ and accounting fees, fees and disbursements of counsel for the Company and the reasonable fees and disbursements of one counsel for the selling Holders shall be borne by the Company, such counsel to be selected by the Selling Holders that hold a majority of the Registrable Securities to be registered. Notwithstanding the foregoing, the Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Section 1.2 or Section 1.4 if the registration request is subsequently withdrawn at the request of the Holders of a majority of the Registrable Securities to be registered other than by reason of cut-back (in which case all participating Holders shall bear such expenses pro rata based upon the number of Registrable Securities that were to be requested in the withdrawn registration); provided further, however, that if at the time of such withdrawal, the Holders have learned of a material adverse change in the condition, business, or prospects of the Company which did not exist at the time of the request, then the Holders shall not be required to pay any such expenses.

1.8 Delay of Registration . No Holder shall have any right to obtain or seek an injunction restraining or otherwise delaying any such registration as the result of any controversy that might arise with respect to the interpretation or implementation of this Section 1.

1.9 Indemnification . In the event any Registrable Securities are included in a registration statement under this Section 1:

(a) To the extent permitted by law, the Company will indemnify and hold harmless each Holder, the partners or officers, directors and stockholders of each Holder, legal counsel and accountants for each Holder, any underwriter (as defined in the Act) for such Holder and each person, if any, who controls such Holder or underwriter within the meaning of the Act or the 1934 Act, against any losses, claims, damages or liabilities (joint or several) to which they may become subject under the Act, the 1934 Act or any other federal or state securities laws, insofar as such losses, claims, damages, or liabilities (or actions in respect thereof) arise out of or are based upon any of the following statements, omissions or violations (collectively a “ Violation ”): (i) any untrue statement or alleged untrue statement of a material fact contained in such registration statement, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto, (ii) the omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading, or (iii) any violation or alleged violation by the Company of the Act, the 1934 Act or any other federal or state securities laws or any rule or

 

10


regulation promulgated under the Act, the 1934 Act or any other federal or state securities laws; and the Company will reimburse each such Holder, underwriter or controlling person for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the indemnity agreement contained in this subsection l.9(a) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld), nor shall the Company be liable in any such case for any such loss, claim, damage, liability or action to the extent that it arises out of or is based upon a Violation that occurs in reliance upon and in conformity with written information furnished to the Company by an instrument duly executed by a Holder, underwriter or controlling person expressly for use in connection with such registration, by any such Holder, underwriter or controlling person; provided further, however, that the foregoing agreement by the Company to indemnify each Holder with respect to any preliminary prospectus shall not inure to the benefit of any Holder or underwriter, or any person controlling such Holder or underwriter, if (i) the person asserting any such losses, claims, damages or liabilities purchased shares in the offering from such Holder, (ii) a copy of the prospectus (as then amended or supplemented if the Company shall have furnished any amendments or supplements thereto) was not sent or given by or on behalf of such Holder or underwriter to such person, if required by law so to have been delivered, at or prior to the written confirmation of the sale of the shares to such person and (iii) the prospectus (as so amended or supplemented) would have cured the defect giving rise to such loss, claim, damage or liability.

(b) To the extent permitted by law, each selling Holder will, severally and not jointly, indemnify and hold harmless the Company, each of its directors, each of its officers who has signed the registration statement, each person, if any, who controls the Company within the meaning of the Act, legal counsel and accountants for the Company, any underwriter, any other Holder selling securities in such registration statement and any controlling person of any such underwriter or other Holder, against any losses, claims, damages or liabilities (joint or several) to which any of the foregoing persons may become subject, under the Act, the 1934 Act or any other federal or state securities laws, insofar as such losses, claims, damages or liabilities (or actions in respect thereto) arise out of or are based upon any Violation, in each case to the extent (and only to the extent) that such Violation occurs in reliance upon and in conformity with written information furnished by such Holder expressly for use in connection with such registration; and each such Holder will reimburse any person intended to be indemnified pursuant to this subsection l.9(b), for any legal or other expenses reasonably incurred by such person in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the indemnity agreement contained in this subsection l.9(b) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Holder (which consent shall not be unreasonably withheld), provided that in no event shall any indemnity under this subsection l.9(b) exceed the net proceeds from the offering received by such Holder.

(c) Promptly after receipt by an indemnified party under this Section 1.9 of notice of the commencement of any action (including any governmental action), such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Section 1.9, deliver to the indemnifying party a written notice of the commencement thereof and the indemnifying party shall have the right to participate in, and, to

 

11


the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one separate counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such proceeding. The failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action, if materially prejudicial to its ability to defend such action, shall relieve such indemnifying party of any liability to the indemnified party under this Section 1.9, but the omission so to deliver written notice to the indemnifying party will not relieve it of any liability that it may have to any indemnified party otherwise than under this Section 1.9. Notwithstanding the foregoing, any indemnifying party shall not enter into any settlement of any such loss, claim, damage, liability or action without the full and complete release of all the indemnified parties.

(d) If the indemnification provided for in this Section 1.9 is held by a court of competent jurisdiction to be unavailable to an indemnified party with respect to any loss, liability, claim, damage or expense referred to herein, then the indemnifying party, in lieu of indemnifying such indemnified party hereunder, shall contribute to the amount paid or payable by such indemnified party as a result of such loss, liability, claim, damage or expense in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one hand and of the indemnified party on the other in connection with the statements or omissions that resulted in such loss, liability, claim, damage or expense, as well as any other relevant equitable considerations; provided, however, that, no contribution by any Holder, when combined with any amounts paid by such Holder pursuant to Section 1.9(b), shall exceed the net proceeds from the offering received by such Holder. The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to information supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or omission.

(e) The obligations of the Company and Holders under this Section 1.9 shall survive the completion of any offering of Registrable Securities in a registration statement under this Section 1, and otherwise.

(f) If, in connection with a Re-Sale Form S-1 filed in accordance with Section 1.3(c) hereof, the SEC explicitly states that a Holder is required under applicable securities law to be described in any registration statement filed by the Company as an underwriter and such Holder consents in writing to being so named as an underwriter, at the request of such Holder, the Company shall furnish to such Holder, on the date of the effectiveness of such registration statement and thereafter from time to time on such dates as such Holder may reasonably request, but in no event more than once per quarter (for all such Holders), (i) a “comfort letter” addressed to such Holder(s), dated as of such date, from the Company’s independent registered public accountants in form and substance as is customarily given by independent registered public accountants to underwriters in an underwritten public

 

12


offering, and (ii) an opinion addressed to such Holder(s), dated as of such date, from counsel representing the Company in form, scope and substance as is customarily given in an underwritten public offering (including a negative assurance statement), for purposes of such registration statement.

1.10 Reports Under Securities Exchange Act of 1934 . With a view to making available to the Holders the benefits of Rule 144 promulgated under the Act and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or pursuant to a registration on Form S-3, the Company agrees to:

(a) make and keep public information available, as those terms are understood and defined in SEC Rule 144, at all times after ninety (90) days after the earlier of the effective date of the registration statement filed by the Company for the Initial Public Offering or the OTC Trading Date;

(b) take such action as is necessary to enable the Holders to utilize Form S-3 for the sale of their Registrable Securities, such action to be taken as soon as practicable after the end of the fiscal year in which the first registration statement filed by the Company for the offering of its securities to the general public is declared effective;

(c) file with the SEC in a timely manner all reports and other documents required of the Company under the Act and the 1934 Act; and

(d) furnish to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) a written statement by the Company that it has complied with the reporting requirements of SEC Rule 144 (at any time after ninety (90) days after the effective date of the first registration statement filed by the Company for the Initial Public Offering or the OTC Trading Date), the Act and the 1934 Act (at any time after it has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form S-3 (at any time after it so qualifies), (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company, and (iii) such other information as may be reasonably requested in availing any Holder of any rule or regulation of the SEC that permits the selling of any such securities without registration or pursuant to such form.

1.11 Assignment of Registration Rights . The rights to cause the Company to register Registrable Securities pursuant to this Section 1 may be assigned (but only with all related obligations) by a Holder to a transferee or assignee of such securities that (i) is an affiliate, subsidiary, parent, partner, limited partner, retired partner or stockholder of a Holder, (ii) is a Holder’s family member or trust for the benefit of an individual Holder, or (iii) after such assignment or transfer, holds at least 250,000 shares of Registrable Securities (subject to appropriate adjustment for stock splits, stock dividends, combinations and other recapitalizations after the date hereof), provided: (a) the Company is, within a reasonable time after such transfer, furnished with written notice of the name and address of such transferee or assignee and the securities with respect to which such registration rights are being assigned; (b) such transferee or assignee agrees in writing to be bound by and subject to the terms and conditions of this Agreement, including without limitation the provisions of Section 1.12 below; and (c) such assignment shall be effective only if immediately following such transfer the further disposition of such securities by the transferee or assignee is restricted under the Act.

 

13


1.12 “Market Stand-Off” Agreement . Each Holder hereby agrees that it will not, without the prior written consent of the managing underwriter, during the period commencing on the date of the final prospectus relating to the Company’s Initial Public Offering and ending on the date specified by the Company and the managing underwriter (such period not to exceed one hundred eighty (l80) days) (i) lend, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock (whether such shares or any such securities are then owned by the Holder or are thereafter acquired), or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Common Stock, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Common Stock or such other securities, in cash or otherwise. Notwithstanding the foregoing, such one hundred eighty (180) day period may be extended as required to comply with FINRA Rule 2711 (or any successor rules or amendments thereto). The foregoing provisions of this Section 1.12 shall apply only to the Company’s Initial Public Offering of equity securities, shall not apply to shares of Common Stock acquired in the Initial Public Offering or in open market transactions after the Initial Public Offering, shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement, and shall only be applicable to the Holders if all officers and directors and greater than one percent (1%) stockholders of the Company enter into similar agreements, and shall not be applicable to any shares of Series E Preferred Stock or shares of Common Stock issued or issuable upon conversion of shares of Series E Preferred Stock following effectiveness of the Re-Sale Form S-1. The underwriters in connection with the Company’s Initial Public Offering are intended third party beneficiaries of this Section 1.12 and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Any discretionary waiver or termination of the restrictions of any or all of such agreements by the Company or the underwriters shall apply pro rata to all Holders subject to such agreements, based on the number of shares subject to such agreements.

In order to enforce the foregoing covenant, the Company may impose stop-transfer instructions with respect to the Registrable Securities of each Holder (and the shares or securities of every other person subject to the foregoing restriction) until the end of such period.

1.13 Termination of Registration Rights . No Holder shall be entitled to exercise any right provided for in this Section 1 after five (5) years following the consummation of the Initial Public Offering.

1.14 Limitations on Subsequent Registration Rights . After the date of this Agreement, the Company shall not, without the prior written consent of the Holders of at least sixty percent (60%) of the Registrable Securities then outstanding, enter into any agreement with any holder or prospective holder of any securities of the Company that would grant such holder registration rights senior, in the good faith judgment of the Board of Directors of the Company, to those granted to the Holders hereunder, unless the Company grants to the Investors similar registration rights.

 

14


2. Covenants of the Company .

2.1 Delivery of Financial Statements . The Company shall deliver to each Major Investor (as defined below in Section 2.3):

(a) as soon as practicable, but in any event within one hundred and twenty (120) days after the end of each fiscal year of the Company, an income statement for such fiscal year, a balance sheet of the Company and statement of stockholder’s equity as of the end of such year, and a statement of cash flows for such year, such year-end financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles (“ GAAP ”), and audited and certified by independent public accountants of nationally recognized standing selected by the Company (the “ Annual Audited Financials ”);

(b) as soon as practicable, but in any event within forty-five (45) days of the end of each quarter of each fiscal year of the Company, an unaudited income statement, statement of cash flows for such fiscal quarter and unaudited balance sheet as of the end of such fiscal quarter (collectively, the “ Unaudited Quarterly Financials ”);

(c) within thirty (30) days of the end of each month, an unaudited income statement and statement of cash flows and balance sheet for and as of the end of such month, in reasonable detail;

(d) promptly upon such Investor’s request and as soon as practicable, but in any event within thirty (30) days of the end of each quarter of each fiscal year of the Company, an updated capitalization table in reasonable detail for the Company, certified as to accuracy by the Company’s Chief Financial Officer or President;

(e) as soon as practicable, but in any event at least thirty (30) days prior to the end of each fiscal year, a budget and business plan for the next fiscal year, prepared on a quarterly basis, including balance sheets, income statements and statements of cash flows on a quarterly basis for such year as such budget and business plan has been approved by the Board of Directors of the Company and, as soon as prepared, any other budgets or revised budgets prepared by the Company;

(f) with respect to the financial statements called for in subsections (b) and (c) of this Section 2.1, an instrument executed by the Chief Financial Officer or President of the Company certifying that such financials were prepared in accordance with GAAP consistently applied with prior practice for earlier periods (with the exception of footnotes that may be required by GAAP) and fairly present the financial condition of the Company and its results of operation for the period specified, subject to year-end audit adjustment; and

(g) such other information relating to the financial condition, business, prospects or corporate affairs of the Company as the Investor or any assignee of the Investor may from time to time request, provided, however, that the Company shall not be obligated under this subsection (e) or any other subsection of Section 2.1 to provide information that it deems in good faith to be a trade secret or similar confidential information.

 

15


Notwithstanding whether Fidelity Advisor Series I: Fidelity Advisor Dividend Growth Fund, Fidelity Advisor Series VII: Fidelity Advisor Biotechnology Fund, Fidelity Magellan Fund: Fidelity Magellan Fund, Fidelity Rutland Square Trust II: Strategic Advisers Core Fund, Fidelity Rutland Square Trust II: Strategic Advisers Core Multi-Manager Fund, Fidelity Securities Fund: Fidelity Dividend Growth Fund, Fidelity Select Portfolios: Biotechnology Portfolio and Variable Insurance Products Fund III: Balanced Portfolio (collectively, the “ Fidelity Investors ”) are then a “Major Investor”, for so long as any of the Fidelity Investors hold any Common Stock or Preferred Stock until this Section 2.1 is terminated pursuant to Section 2.8, the Company shall deliver or make available to the Fidelity Investors the Annual Audited Financials and the Unaudited Quarterly Financials within such time periods and including such detail and certifications as set forth in paragraphs (a) and (b) of this Section 2.1. Notwithstanding anything to the contrary in this Agreement, the information rights afforded to the Fidelity Investors in this Section 2.1 shall not be amended, modified, terminated or waived without the express prior written consent of the Fidelity Investors.

2.2 Inspection . The Company shall permit each Major Investor (as defined below in section 2.3), at such Investor’s expense, to visit and inspect the Company’s properties, to examine its books of account and records and to discuss the Company’s affairs, finances and accounts with its officers, all at such reasonable times as may be requested by the Investor; provided, however, that the Company shall not be obligated pursuant to this Section 2.2 to provide access to any information that it reasonably considers to be a trade secret or similar confidential information.

2.3 Right of First Offer . Subject to the terms and conditions specified in this paragraph 2.3, the Company hereby grants to each Major Investor (as hereinafter defined) a right of first offer with respect to future sales by the Company of its Shares (as hereinafter defined). “ Major Investor ” shall mean any Investor (or any Investor together with such Investor’s affiliates) or transferee that holds at least 1,000,000 shares of Preferred Stock (or the Common Stock issued upon conversion thereof), as adjusted for stock splits, stock dividends, combinations and other recapitalizations after the date hereof. The term Major Investor includes any general partners and affiliates of an Investor. A Major Investor shall be entitled to apportion the right of first offer hereby granted it among itself and its partners and affiliates in such proportions as it deems appropriate.

Each time the Company proposes to offer any shares of, or securities convertible into or exchangeable or exercisable for any shares of any class of its capital stock (“ Shares ”), the Company shall first make an offering of such Shares to each Major Investor in accordance with the following provisions.

(a) The Company shall deliver a notice in accordance with Section 3.5 (“ Notice ”) to the Major Investors stating (i) its bona fide intention to offer such Shares, (ii) the number of such Shares to be offered, and (iii) the price and terms upon which it proposes to offer such Shares.

(b) By written notification received by the Company, within twenty (20) calendar days after receipt of the Notice, the Major Investor may elect to purchase or obtain, at the price and on the terms specified in the Notice, up to that portion of such Shares that equals the proportion that the number of shares of Common Stock issued and held, or issuable

 

16


upon conversion of the Preferred Stock then held, by such Major Investor bears to the total number of shares of Common Stock of the Company then outstanding (assuming full conversion of all convertible securities) issued and held, or issuable upon conversion of the Preferred Stock then held, by all the Major Investors (the “ Pro Rata Share ”). The Company shall promptly, in writing, inform each Major Investor that elects to purchase all the Shares available to it (a “ Fully-Exercising Investor ”) of any other Major Investor’s failure to do likewise (the “ Unsubscribed Shares ”). During the ten (10) day period commencing after such information is given, each Fully-Exercising Investor may elect to purchase that portion of the Unsubscribed Shares that is equal to the proportion that the number of shares of Registrable Securities issued and held by such Fully-Exercising Investor bears to the total number of shares of Common Stock issued and held, or issuable upon conversion of the Preferred Stock then held, by all Fully-Exercising Investors who wish to purchase some of the unsubscribed shares.

(c) In the event any Unsubscribed Shares remain available for purchase, any other Fully-Exercising Investor may elect to purchase that portion of the Unsubscribed Shares that is equal to the proportion of the number of shares of Common Stock issued and held, or issuable upon conversion of Preferred Stock then held, by such Fully-Exercising Investor bears to the total number of shares of Common Stock issued and held, or issuable upon conversion of the Preferred Stock then held, by all Fully-Exercising Investors who wish to purchase some of the Unsubscribed Shares.

(d) If all Shares that Major Investors are entitled to obtain pursuant to subsection 2.3(b) are not elected to be obtained as provided in subsection 2.3(b) hereof, the Company may, during the ninety (90) day period following the expiration of the period provided in subsection 2.3(b) hereof, offer the remaining unsubscribed portion of such Shares to any person or persons at a price not less than, and upon terms no more favorable to the offeree than those specified in the Notice. If the Company does not enter into an agreement for the sale of the Shares within such period, or if such agreement is not consummated within ninety (90) days of the execution thereof, the right provided hereunder shall be deemed to be revived and such Shares shall not be offered unless first reoffered to the Major Investors in accordance herewith.

(e) The right of first offer in this paragraph 2.3 shall not be applicable to (i) the issuance of Common Stock (or options therefor) to employees, directors and consultants for the primary purpose of soliciting or retaining their services pursuant to a stock option plan, performance bonus plan or restricted stock plan approved by the Company’s Board of Directors; (ii) the issuance of securities pursuant to a bona fide, firmly underwritten public offering of shares of Common Stock, registered under the Act, (iii) the issuance of securities pursuant to the conversion or exercise of Preferred Stock and warrants to purchase Series B Preferred Stock outstanding on the date hereof, (iv) the issuance of securities in connection with a bona fide business acquisition of or by the Company, whether by merger, consolidation, sale of assets, sale or exchange of stock or otherwise, which has been approved and deemed not to be “Additional Stock” (as defined in the Company’s Amended and Restated Certificate of Incorporation as filed on or about the date hereof (the “ Company Charter ”)) by the Board of Directors of the Company, (v) the issuance of stock, warrants or other securities or rights in connection with certain commercial credit arrangements, equipment lease financings or similar transactions approved by the Board of Directors, which has been approved and deemed not to be

 

17


“Additional Stock” (as defined in the Company Charter) by the Board of Directors of the Company, (vi) the issuance of securities for licenses to technology or pharmaceutical drugs or compounds, which has been approved and deemed not to be “Additional Stock” (as defined in the Company Charter) by the Board of Directors of the Company, (vii) the issuance of shares of Series E Preferred Stock issued pursuant to the Series E Agreement (including, without limitation, any such shares issued pursuant to a PIPE Offering), or (viii) without duplication, the issuance of shares of Common Stock or Preferred Stock issued pursuant to a PIPE Offering.

2.4 Employee Agreements . Unless approved by the Board of Directors of the Company, all future employees of the Company who shall purchase, or receive options to purchase, shares of the Company’s Common Stock following the date hereof shall be required to execute stock purchase or option agreements providing for vesting of shares over a four-year period with the first 25% of such shares vesting following twelve (12) months of continued employment or services, and the remaining shares vesting in equal monthly installments over the following 36 months thereafter.

2.5 Key-Man Insurance . The Company shall purchase and maintain term life insurance on the life of its Chief Executive Officer (currently David Pritchard) in an amount approved by the Board of Directors. Such policy shall name the Company as loss payee and shall not be cancelable by the Company without prior approval of the Board of Directors.

2.6 Directors and Officers Insurance . The Company shall make commercially reasonable efforts to maintain (so long as it continues to be available on commercially reasonable terms as determined by the Board of Directors) from financially sound and reputable insurers, directors and officers insurance with coverage customary for companies similarly situated to the Company. In the event the Company is subject to a Liquidation Event (as defined in the Company Charter), the Company shall use its reasonable efforts to cause the successor entity in the Liquidation Event to assume the Company’s obligations with respect to the indemnification of members of the Company’s Board of Directors.

2.7 Other Covenants . So long as at least fifty percent (50%) of the originally issued shares of Preferred Stock remain outstanding, the Company will not, without approval of the Board of Directors, which approval shall include the approval of at least two (2) members of the Board of Directors who are elected by holders of Preferred Stock:

(a) make any loan or advance to, or own any stock or other securities of, any subsidiary or other corporation, partnership, or other entity unless it is wholly owned by the Company;

(b) make any loan or advance to any person, including, any employee or director, except advances and similar expenditures in the ordinary course of business or under the terms of an employee stock or option plan approved by the Board of Directors;

(c) guarantee any indebtedness except for trade accounts of the Company or any subsidiary arising in the ordinary course of business;

 

18


(d) make any investment other than investments in prime commercial paper, money market funds, certificates of deposit in any United States bank having a net worth in excess of $100,000,000 or obligations issued or guaranteed by the United States of America, in each case having a maturity not in excess of two years;

(e) incur any aggregate indebtedness in excess of $500,000 that is not already included in a budget approved by the Company’s Board of Directors, other than trade credit incurred in the ordinary course of business;

(f) enter into or be a party to any transaction with any director or officer of the Company or any “associate” (as defined in Rule 12b-2 promulgated under the 1934 Act) of any such person;

(g) hire, fire, or change the compensation of the executive officers, including approving any Company option plans for such persons;

(h) change the principal business of the Company, enter new lines of business, or exit the Company’s current line of business;

(i) sell, transfer, license, pledge or encumber technology or intellectual property, other than licenses granted in the ordinary course of business; or

(j) make any material investments, joint ventures, or acquisitions.

2.8 Termination of Certain Covenants . The covenants set forth in Sections 2.1 through 2.7, inclusive, shall terminate and be of no further force or effect upon (a) the consummation of the sale of securities pursuant to a bona fide, firmly underwritten public offering on the NASDAQ Global Market, the NASDAQ Global Select Market or the New York Stock Exchange of shares of common stock, registered under the Act, with a pre-Initial Public Offering valuation of at least $225,000,000 and resulting in gross proceeds to the Company of not less than $30,000,000, (b) the date on which a Re-Sale Form S-1 becomes effective or (c) the consummation of a Liquidation Event (as defined in the Company Charter).

2.9 Fidelity Covenants . So long as any Fidelity Investor holds any shares of Preferred Stock or shares of Common Stock issued upon conversion of such shares of Preferred Stock (collectively, the “ Fidelity Stock ”), neither the Company nor the Company’s Board of Directors nor any Investor or group of Investors shall, without the express prior written consent of the Fidelity Investors, approve or authorize any amendment, alteration or repeal to the Company Charter, the By-Laws of the Company, this Agreement, the Series E Agreement, the Amended and Restated Voting Agreement with the Company or the Amended and Restated Right of First Refusal and Co-Sale Agreement with the Company, in each case, as in effect on the date of this Agreement, or enter into any other agreement, in each case, to the extent that any such amendment, alteration or repeal or new agreement would further restrict or limit the transferability of any shares of the Fidelity Stock beyond the restrictions and limitations provided in the documents specified above as in effect on the date hereof. Notwithstanding anything to the contrary in this Agreement, the consent right afforded to the Fidelity Investors in this Section 2.9 shall not be amended, modified, terminated or waived without the express prior written consent of the Fidelity Investors.

 

19


2.10 Initial Public Offering Directed Shares . In connection with an Initial Public Offering of the Company’s Common Stock consummated at least one (1) year after the date hereof (or such earlier date as permitted under applicable regulations), the Company will use its commercially reasonable efforts to cause the managing underwriter(s) of the Initial Public Offering to designate a number of shares equal to five percent (5%) of the Common Stock to be offered in the Initial Public Offering for sale under a “directed shares program” and shall instruct such underwriter(s) to allocate all shares subject to such directed shares program to be sold to persons and entities designated by the Major Investors. The shares designated by the underwriter(s) for sale under a directed shares program are referred to herein as “ directed shares .” The number of directed shares that a Major Investor may designate to be sold shall be determined on a pro rata basis, in proportion to the number of shares of Registrable Securities held by each Major Investor relative to all Major Investors, calculated on an as-converted to Common Stock basis. Each of the Major Investors shall have the right to apportion the number of directed shares that a Major Investor may designate to be sold among any of its partners, members, affiliates, predecessor or successor venture capital funds, or persons or entities under common investment management with such Major Investor. The Major Investors acknowledge that, despite the Company’s use of its commercially reasonable efforts, the underwriter(s) may determine in their sole discretion that it is not advisable to designate all such shares as directed shares in the Initial Public Offering, in which case the number of directed shares may be reduced or no directed shares may be designated, as applicable. The Major Investors also acknowledge that notwithstanding the terms of this Agreement, the sale of any directed shares to any Major Investor pursuant to this Agreement will only be made in compliance with FINRA Rules 2110 and 2790, or any successor rules, and federal, state, and local laws, rules, and regulations, and only if the Initial Public Offering is consummated after one (1) year from the date hereof. Upon the effectiveness of this Agreement, this supersedes and terminates that certain Letter Agreement among the Company and certain purchasers the Company’s Series B-2 Preferred Stock (each of whom are a party hereto), dated on or around January 27, 2005, regarding the right to participate in an Initial Public Offering of the Company’s securities.

3. Miscellaneous .

3.1 Successors and Assigns . Except as otherwise provided herein, the terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties (including transferees of any shares of Registrable Securities). Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

3.2 Governing Law . This Agreement shall be governed by and construed under the laws of the State of California as applied to agreements among California residents entered into and to be performed entirely within California.

 

20


3.3 Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

3.4 Titles and Subtitles . The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

3.5 Notices . All notices and other communications given or made pursuant hereto shall be in writing and shall be deemed effectively given upon the earlier to occur of actual receipt or: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient; if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All notices and other communications shall be sent to the Company at 260 East Grand Avenue, South San Francisco, CA 94080, Attention: Chief Executive Officer and to the other parties at the addresses set forth on Schedule A (or at such other addresses as shall be specified by notice given in accordance with this Section 3.5).

3.6 Expenses . If any action at law or in equity is necessary to enforce or interpret the terms of this Agreement, the prevailing party shall be entitled to reasonable attorneys’ fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled.

3.7 Entire Agreement: Amendments and Waivers . This Agreement (including the Exhibits hereto, if any) constitutes the full and entire understanding and agreement among the parties with regard to the subjects hereof and thereof and supersedes any prior agreements made regarding such subjects. Except as otherwise specified in Sections 2.1 and 2.9 of this Agreement, any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and the holders of sixty-percent (60%) of the Registrable Securities; provided, however, that any amendment that adversely and disproportionately affects the shares of Series E Preferred Stock (or shares of Common Stock issuable upon conversion thereof) in a manner different than the other series of Preferred Stock or the Common Stock shall require the prior written consent of the holders of at least sixty percent (60%) of the then outstanding shares of Series E Preferred Stock. Any amendment or waiver effected in accordance with this paragraph shall be binding upon each holder of any Registrable Securities each future holder of all such Registrable Securities, and the Company. The parties hereby agree and acknowledge that the addition of an additional party pursuant to Section 3.11 below shall not constitute an amendment or waiver of this Agreement.

3.8 Severability . If one or more provisions of this Agreement are held to be unenforceable under applicable law, such provision shall be excluded from this Agreement and the balance of the Agreement shall be interpreted as if such provision were so excluded and shall be enforceable in accordance with its terms.

 

21


3.9 Aggregation of Stock . All shares of Registrable Securities held or acquired by affiliated entities or persons shall be aggregated together for the purpose of determining the availability of any rights under this Agreement. For purposes of this Agreement, the mutual funds, other pooled vehicles and client accounts on whose behalf the Fidelity Investors and their respective investment advisory affiliates exercise investment discretion shall be considered affiliates or affiliated entities or persons of such Fidelity Investors and such investment advisory affiliates.

3.10 Directors’ Expenses . The Company shall (i) hold meetings of the Board of Directors at least bimonthly, unless otherwise approved by a vote of a majority of the Directors elected by the holders of Preferred Stock and (ii) pay the reasonable out-of-pocket expenses of all Directors (other than Directors who are founders or employees of the Company) in attending all meetings of the Board of Directors and committees thereof and performing their duties as Directors.

3.11 Additional Parties . In the event of a subsequent closing with an investor as provided for in Section 1.3 of the Series E Agreement, such investor shall become a party to this Agreement as an “Investor” upon receipt from such investor of a fully executed signature page hereto.

3.12 Termination of Prior Agreement . Upon the effectiveness of this Agreement, the Prior Agreement shall terminate and be of no further force and effect, and shall be superseded and replaced in its entirety by this Agreement.

3.13 Massachusetts Business Trust . A copy of the Agreement and Declaration of Trust of each Fidelity Investor (or any affiliate thereof) is on file with the Secretary of the Commonwealth of Massachusetts and notice is hereby given that this Agreement is executed on behalf of the trustees of each such Fidelity Investor or any such affiliate thereof as trustees and not individually and that the obligations of this Agreement are not binding on any of the trustees, officers or stockholders of any such Fidelity Investor or any such affiliate thereof individually but are binding only upon each such Fidelity Investor or any such affiliate thereof and its assets and property.

[Remainder of page intentionally left blank.]

 

22


IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.

 

  KALOBIOS PHARMACEUTICALS, INC.
  /s/ David Pritchard
  David Pritchard
  Chief Executive Officer
Address:   260 East Grand Avenue
  South San Francisco, CA 94080

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


INVESTORS:
FIDELITY MAGELLAN FUND:
FIDELITY MAGELLAN FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY SELECT PORTFOLIOS:
BIOTECHNOLOGY PORTFOLIO
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY ADVISOR SERIES VII:
FIDELITY ADVISOR BIOTECHNOLOGY
FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

 

 

 

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


INVESTORS:
VARIABLE INSURANCE PRODUCTS
FUND III: BALANCED PORTFOLIO
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY ADVISOR SERIES I:
FIDELITY ADVISOR DIVIDEND
GROWTH FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY SECURITIES FUND:

FIDELITY DIVIDEND GROWTH FUND

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


INVESTORS:
FIDELITY RUTLAND SQUARE TRUST II:
STRATEGIC ADVISERS CORE MULTI-
MANAGER FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY RUTLAND SQUARE TRUST II:
STRATEGIC ADVISERS CORE FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer
Address for Notices:  

Andrew Boyd

Fidelity Investments

82 Devonshire Street, V13H

Boston, MA 02109

Tel: 617-563-5144

Fax: 617-385-2818

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


  INVESTORS :
  Mitsubishi UFJ Capital II, Limited partnership
  by:   Mitsubishi UFJ Capital its General Partner
  By:   /s/ Yoshihiro Hashimoto
  Name:   Yoshihiro Hashimoto
  Title:   President
Address:   1-7-17 Nihonbashi, Chuo-ku
  Tokyo, 103-0027, Japan

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


  INVESTORS:
  GENZYME CORPORATION
  By:   /s/ David Meeker
  Name:   David Meeker
  Title:   President and Chief Executive Officer
Address:  

Genzyme Corporation

500 Kendall Street

Cambridge, MA 02142

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


INVESTORS:
LB I GROUP INC.
By:   /s/ Ashvin Rao
Name:   Ashvin Rao
Title:   Vice President

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


INVESTORS:
MPM BIOVENTURES III, L.P.
By:   MPM BioVentures III GP, L.P., its General Partner
By:   MPM BioVentures III LLC, its General Partner
By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

MPM BIOVENTURES III-QP, L.P.
By:   MPM BioVentures III GP, L.P., its General Partner
By:   MPM BioVentures III LLC, its General Partner
By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

MPM BIOVENTURES III GMBH & CO.

BETEILIGUNGS KG

By:   MPM BioVentures III GP, L.P., in its capacity as the Managing Limited Partner
By:   MPM BioVentures III LLC, its General Partner
By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

.

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


INVESTORS:

 

MPM BIOVENTURES III PARALLEL

FUND, L.P.

By:

 

MPM BioVentures III GP, L.P.,

its General Partner

By:

 

MPM BioVentures III LLC,

its General Partner

By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

MPM ASSET MANAGEMENT

INVESTORS 2005 BVIII LLC

By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Manager

 

MPM BIOVENTURES STRATEGIC FUND,

L.P.

By:

 

MPM BioVentures III GP, L.P.,

its General Partner

By:

 

MPM BioVentures III LLC,

its General Partner

By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


INVESTORS:

 

S OFINNOVA V ENTURE P ARTNERS V, LP

By:

 

Sofinnova Management V 2005, LLC

Its General Partner

By:   /s/ James I. Healy
  James I. Healy, Managing Director

 

S OFINNOVA V ENTURE A FFILIATES V, LP

By:

 

Sofinnova Management V, LLC

Its General Partner

By:   /s/ James I. Healy
  James I. Healy, Managing Director

 

S OFINNOVA V ENTURE P RINCIPALS V, LP

By:

 

Sofinnova Management V, LLC

Its General Partner

By:   /s/ James I. Healy
  James I. Healy, Managing Director

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


  INVESTORS:
 

 

ALLOY PARTNERS 2000, L.P.

ALLOY VENTURES 2000, L.P.

ALLOY CORPORATE 2000, L.P.

ALLOY INVESTORS 2000, L.P.

ALLOY ANNEX I, L.P.

 

/s/ [Illegible]

  By:  

Alloy Ventures 2000, LLC,

its General Partner

Address:  

480 Cowper Street, 2 nd Floor

Palo Alto, CA 94301

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


          INVESTORS:    
 

Signed  for and on behalf of  GBS Venture

Partners Limited (ABN 54 072 515 247) in

its capacity as trustee of GBS BioVentures II

 

/s/ Brigitte Smith

   

/s/ Geoff Brooke

  Director     Director
 

Brigitte Smith

   

Geoff Brooke

  Name     Name
 

Signed for and on behalf of GBS Venture

Partners Limited (ABN 54 072 515 247)

in its capacity as trustee of the Genesis Fund

 

/s/ Brigitte Smith

   

/s/ Geoff Brooke

  Director     Director
 

Brigitte Smith

   

Geoff Brooke

  Name     Name

Address:

 

Level 5, 71 Collins St.

Melbourne Vic, Australia

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


 

INVESTORS:

 

5AM VENTURES LLC

  By:   /s/ [Illegible]
  Name:    
  Title:    

Address:

 

2200 Sand Hill Road, Suite 110

Menlo Park, CA 94025

 

  5AM CO-INVESTORS LLC
  By:   /s/ [Illegible]
  Name:    
  Title:    
Address:  

2200 Sand Hill Road, Suite 110

Menlo Park, CA 94025

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


 

INVESTORS :

 

G&H PARTNERS

  By:   /s/ Jonathan Gleason
  Name:   Jonathan Gleason
  Title:    
Address:  

c/o Gunderson Dettmer

1200 Seaport Blvd.

Redwood City, CA 94063

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


 

INVESTORS :

 

BAXTER INTERNATIONAL INC.

  By:   /s/ Michael Baughman
  Name:   Michael Baughman
  Title:   CVP Controller
Address:  

One Baxter Parkway

Deerfield, IL 60015-4625

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT


Schedule A

5AM Ventures, LLC

5AM Co-Investors, LLC

Singapore Bio-Innovations Pte Ltd.

Sofinnova Venture Partners V, LP

Sofinnova Ventures Affiliates V, LP

Sofinnova Venture Principals V, LP

Alloy Partners 2000, L.P.

Alloy Ventures 2000, L.P.

Alloy Corporate 2000, L.P.

Alloy Investors 2000, L.P.

Alloy Annex I, L.P.

Robert Balint

James Larrick

Lotus BioScience Investment Holdings Ltd.

GBS Venture Partners Limited, as trustee of the Bioscience Ventures II Fund and the Genesis Fund

MPM BioVentures III, L.P.

MPM BioVentures III-QP, L.P.

MPM BioVentures III GmbH & Co. Beteiligungs KG

MPM BioVentures III Parallel Fund, L.P.

MPM Asset Management Investors 2005 BVIII LLC

MPM BioVentures Strategic Fund, L.P.

Howard Baer

Stuart Builder

George Sachs

LB I Group Inc.

Mitsubishi UFJ Capital II, Limited partnership

Genzyme Corporation

G&H Partners

Montgomery & Co., LLC

Baxter International Inc.

Development Bank of Japan

Fidelity Advisor Series I: Fidelity Advisor Dividend Growth Fund

Fidelity Advisor Series VII: Fidelity Advisor Biotechnology Fund

Fidelity Magellan Fund: Fidelity Magellan Fund

Fidelity Rutland Square Trust II: Strategic Advisers Core Fund

Fidelity Rutland Square Trust II: Strategic Advisers Core Multi-Manager Fund

Fidelity Securities Fund: Fidelity Dividend Growth Fund

Fidelity Select Portfolios: Biotechnology Portfolio

Variable Insurance Products Fund III: Balanced Portfolio

Exhibit 10.9

AMENDED AND RESTATED VOTING AGREEMENT

This AMENDED AND RESTATED VOTING AGREEMENT (the “ Voting Agreement ”) is made and entered into as of May 2, 2012, by and among KaloBios Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”), the holders of the Company’s Series A Preferred Stock (the “ Series A Preferred Stock ”), Series B-1 Preferred Stock (the “ Series B-1 Preferred Stock ”), Series B-2 Preferred Stock (the “ Series B-2 Preferred Stock ”), Series C Preferred Stock (the “ Series C Preferred Stock ”), Series D Preferred Stock (the “ Series D Preferred Stock ”) and Series E Preferred Stock (the “ Series E Preferred Stock ”, and collectively with the Series A Preferred Stock, Series B-1 Preferred Stock, Series B-2 Preferred Stock, Series C Preferred Stock and Series D Preferred Stock, the “ Preferred Stock ”) as listed on the Schedule of Investors attached as Exhibit A hereto (individually, an “ Investor ” and collectively, the “ Investors ”), and certain holders of Common Stock of the Company (individually, a “ Common Holder ” and collectively, the “ Common Holders ”) listed on the Schedule of Common Holders attached as Exhibit B hereto. The Company, the Common Holders and the Investors are individually each referred to herein as a “ Party ” and are collectively referred to herein as the “ Parties .” The Company’s Board of Directors is referred to herein as the “ Board .”

WITNESSETH:

WHEREAS, the Company, the Common Holders, and certain of the Investors (the “ Existing Investors ”) are parties to that certain Amended and Restated Voting Agreement, dated as of September 22, 2008 (the “ Prior Agreement ”);

WHEREAS, the Company and certain of the Investors (the “ New Investors ”) are parties to the Series E Preferred Stock Purchase Agreement dated of even date herewith (the “ Series E Agreement ”), pursuant to which the New Investors are purchasing shares of the Company’s Series E Preferred Stock;

WHEREAS, the Company, the Common Holders and the Existing Investors wish to provide further inducement to the New Investors to purchase the Series E Preferred Stock by amending and restating the Prior Agreement to include the New Investors and to amend and restate the rights and obligations set forth therein, in each case as set forth herein;

WHEREAS, the Prior Agreement may be amended with the consent of the Company, the holders of a majority of the then outstanding Common Stock held by the Common Holders (a “ Majority of Common Holders ”), and Investors holding at least sixty percent (60%) of the outstanding Preferred Stock held by the Investors;

WHEREAS, the Company, a Majority of Common Holders and Investors holding at least sixty percent (60%) of the outstanding Preferred Stock held by the Investors are parties hereto; and


WHEREAS, the Company’s Amended and Restated Certificate of Incorporation filed in connection with the closing of the Series E Agreement (the “ Company’s Amended and Restated Certificate of Incorporation ”) provides that (a) holders of shares of Preferred Stock, voting together as a single class, shall elect two (2) members of the Board (the “ Preferred Directors ”) and (b) holders of shares of Preferred Stock and Common Stock, voting together as a single class, shall be entitled to elect any remaining members of the Board (the “ At-Large Director(s) ”).

NOW, THEREFORE, in consideration of the foregoing premises and certain other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. Agreement to Vote . Each Investor, as a holder of Preferred Stock, hereby agrees on behalf of itself and any transferee or assignee of any such shares of the Preferred Stock, to hold all of the shares of Preferred Stock registered in its name (and any securities of the Company issued with respect to, upon conversion of, or in exchange or substitution of the Preferred Stock, and any other voting securities of the Company subsequently acquired by such Investor) (hereinafter collectively referred to as the “ Investor Shares ”) subject to, and to vote the Investor Shares at a regular or special meeting of stockholders (or by written consent) in accordance with, the provisions of this Agreement. Each Common Holder, as a holder of Common Stock of the Company, hereby agrees on behalf of itself and any transferee or assignee of any such shares of Common Stock, to hold all of such shares of Common Stock and any other securities of the Company acquired by such Common Holder in the future (and any securities of the Company issued with respect to, upon conversion of, or in exchange or substitution for such securities) (the “ Common Holder Shares ”) subject to, and to vote the Common Holder Shares at a regular or special meeting of stockholders (or by written consent) in accordance with, the provisions of this Agreement.

2. Board Size . The holders of Investor Shares and Common Holder Shares shall vote at a regular or special meeting of stockholders (or by written consent) such shares that they own (or as to which they have voting power) to ensure that the size of the Board shall be set at nine (9) directors; provided, however, that such Board size may be subsequently increased or decreased pursuant to an amendment of this Agreement in accordance with Section 16 hereof.

3. Election of Directors and Observation Rights .

(a) For so long as each of 5AM Ventures LLC and its affiliated funds (collectively, “ 5AM ”), Singapore Bio-Innovations Pte Ltd. and its affiliated funds (collectively “ Singapore ”), GBS Venture Partners Limited and its affiliated funds (collectively “ GBS ”) and Alloy Ventures and its affiliated funds (collectively “ Alloy ”) holds in the aggregate at least three percent (3%) of the Fully-Diluted Capital Stock (as defined below) of the Company (as adjusted for stock splits, stock dividends, recapitalizations or the like), each of 5AM, Singapore, GBS and Alloy shall be entitled to the following rights:

(i) If a designee of Singapore is not represented on the Board, then the Company shall invite a representative of Singapore to attend all meetings of the Board (and all committees thereof) in a nonvoting observer capacity and, in this respect, shall give such representative copies of all notices, minutes, consents, and other material that it provides to its directors; provided, however, that the Company shall reserve the right to exclude such

 

2


representative from access to any material or meeting or portion thereof if the Company believes upon advice of counsel that such exclusion is reasonably necessary to preserve the attorney-client privilege. Such representative may participate in discussions of matters brought to the Board.

(ii) If a designee of 5AM is not represented on the Board, the Company shall invite a representative of 5AM to attend all meetings of the Board (and all committees thereof) in a nonvoting observer capacity and, in this respect, shall give such representative copies of all notices, minutes, consents, and other material that it provides to its directors; provided, however, that the Company shall reserve the right to exclude such representative from access to any material or meeting or portion thereof if the Company believes upon advice of counsel that such exclusion is reasonably necessary to preserve the attorney-client privilege. Such representative may participate in discussions of matters brought to the Board.

(iii) If a designee of GBS is not represented on the Board, the Company shall invite a representative of GBS to attend all meetings of the Board (and all committees thereof) in a nonvoting observer capacity and, in this respect, shall give such representative copies of all notices, minutes, consents, and other material that it provides to its directors; provided, however, that the Company shall reserve the right to exclude such representative from access to any material or meeting or portion thereof if the Company believes upon advice of counsel that such exclusion is reasonably necessary to preserve the attorney-client privilege. Such representative may participate in discussions of matters brought to the Board.

(iv) If a designee of Alloy is not represented on the Board, the Company shall invite a representative of Alloy to attend all meetings of the Board (and all committees thereof) in a nonvoting observer capacity and, in this respect, shall give such representative copies of all notices, minutes, consents, and other material that it provides to its directors; provided, however, that the Company shall reserve the right to exclude such representative from access to any material or meeting or portion thereof if the Company believes upon advice of counsel that such exclusion is reasonably necessary to preserve the attorney-client privilege. Such representative may participate in discussions of matters brought to the Board.

(b) In any election of directors of the Company to elect the Preferred Directors, the Parties holding shares of Preferred Stock shall each vote at any regular or special meeting of stockholders (or by written consent) such number of shares of Preferred Stock then owned by them (or as to which they then have voting power) as may be necessary to elect (i) one (1) director nominated by funds managed by or affiliated with Sofinnova Ventures, Inc. (“ Sofinnova ”), which director shall initially be James Healy, for so long as Sofinnova holds at least five percent (5%) of the Fully-Diluted Capital Stock (as defined below) of the Company (as adjusted for stock splits, stock dividends, recapitalizations or the like) and (ii) one (1) director nominated by a majority of the holders of shares of Preferred Stock, voting together as a single class, which director shall initially be Dennis Henner. James Healy shall initially serve as Chairman of the Board.

 

3


(c) (i) In any election of directors of the Company to elect At-Large Directors, the Parties holding shares of Common Stock and Preferred Stock shall each vote at any regular or special meeting of stockholders (or by written consent) such number of shares of Common Stock and/or Preferred Stock then owned by them (or as to which they then have voting power) as may be necessary to elect one (1) director who shall be the Company’s then current Chief Executive Officer (“ CEO ”). Such At-Large Director shall initially be David Pritchard; and

(ii) In any election of directors of the Company to elect additional At-Large Directors, whom, in the reasonable judgment of the Board of Directors of the Company, shall be recognized experts in the biotechnology field, and shall not be employed by the Company, the Investors and the Common Holders shall each vote at any regular or special meeting of stockholders (or by written consent) such number of voting securities of the Company then owned by them (or as to which they then have voting power) as may be necessary to elect the At-Large Directors that are nominated by a majority of the holders of shares of Preferred Stock and Common Stock, voting together as a single class, which directors shall initially be Brigitte Smith, Ted Love, Gary Lyons, Denise Gilbert and Ray Withy.

For purposes of this Agreement, “ Fully-Diluted Capital Stock ” shall mean (A) outstanding Common Stock, (B) Common Stock issuable upon conversion of Preferred Stock, (C) Common Stock issuable upon exercise of outstanding options and (D) Common Stock issuable upon exercise (and, in the case of warrants to purchase Preferred Stock, conversion) of outstanding warrants.

4. Removal . Any director of the Company may be removed from the Board in the manner allowed by law and the Company’s Amended and Restated Certificate of Incorporation and Bylaws, but with respect to a director designated pursuant to subsections 3(b) and 3(c), only upon the vote or written consent of the stockholders holding a majority of the shares or directors entitled to designate such director.

5. Legend on Share Certificates . Each certificate representing any Shares shall be endorsed by the Company with a legend reading substantially as follows:

“THE SHARES EVIDENCED HEREBY ARE SUBJECT TO A VOTING AGREEMENT (A COPY OF WHICH MAY BE OBTAINED UPON WRITTEN REQUEST FROM THE ISSUER), AND BY ACCEPTING ANY INTEREST IN SUCH SHARES THE PERSON ACCEPTING SUCH INTEREST SHALL BE DEEMED TO AGREE TO AND SHALL BECOME BOUND BY ALL THE PROVISIONS OF SAID VOTING AGREEMENT.”

6. “Drag Along” Right . In the event that the Board and the holders of at least sixty percent (60%) of the then outstanding shares of Preferred Stock (on an as-converted basis) approve a Liquidation Event (as defined in the Company’s Amended and Restated Certificate of Incorporation) (a “ Sale of the Company ”), then each Investor and Common Holder hereby agrees with respect to all securities of the Company which it own(s) or otherwise exercises voting or dispositive authority:

 

4


(a) In the event the Sale of the Company is to be brought to a vote at a stockholder meeting, after receiving proper notice of any meeting of stockholders of the Company to vote on the approval of a Sale of the Company, to be present, in person or by proxy, as a holder of shares of voting securities, at all such meetings and be counted for the purposes of determining the presence of a quorum at such meetings;

(b) to vote (in person, by proxy or by action by written consent, as applicable) all shares of the capital stock of the Company as to which it has beneficial ownership in favor of such Sale of the Company and in opposition of any and all other proposals that could reasonably be expected to delay or impair the ability of the Company to consummate such Sale of the Company;

(c) to refrain from exercising any dissenters’ rights or rights of appraisal under applicable law at any time with respect to such Sale of the Company;

(d) to execute and deliver all related documentation and take such other action in support of the Sale of the Company as shall reasonably be requested by the Company; and

(e) except for this Voting Agreement, neither any of the parties hereto nor any affiliates thereof shall deposit any shares of capital stock beneficially owned by such party or affiliate in a voting trust or subject any such shares of capital stock to any arrangement or agreement with respect to the voting of such shares of capital stock.

Notwithstanding the foregoing, (x) no Investor or Common Holder shall be required to comply with the provisions of this Section 6 with respect to a Sale of the Company (i) if such Investor or Common Holder (solely in its role as a stockholder) is required to (A) make representations and warranties in any documentation to be entered into in connection with the Sale of the Company (the “ Merger Documents ”), that are different than the representations and warranties provided by other stockholders (solely in their role as a stockholder) or (B) contribute additional capital or assets in connection with such sale of the Company, unless such Investor or Common Holder otherwise agrees, or (ii) unless (A) the net proceeds of such Sale of the Company are to be distributed to stockholders of the Company in accordance with the Company’s Amended and Restated Certificate of Incorporation, (B) the liability of each stockholder on account of such sale or transaction, is several and not joint with any other person (except to the extent that funds may be paid out of an escrow established to cover breach of representations, warranties and covenants of the Company as well as breach by any stockholder of any of identical representations, warranties and covenants provided by all stockholders), and will not exceed the value of the consideration received by such stockholder in the sale or transaction; and (C) the amount payable by such stockholder of the Company on account of any particular claim made against it (including any escrowed proceeds received by it) will not exceed its proportional allocation based on the respective amount of consideration received by it in such transaction relative to all other stockholders and (y) no holder of Series E Preferred Stock shall be required to comply with the provisions of this Section 6 with respect to a Sale of the Company

 

5


unless such holder would receive for each share of Series E Preferred Stock held by such holder an amount of consideration in such transaction greater than or equal to the Participation Cap applicable to the Series E Preferred Stock (as defined in the Company’s Amended and Restated Certificate of Incorporation).

7. Covenants of the Company . The Company agrees to use its best efforts to ensure that the rights granted hereunder are effective and that the Parties hereto enjoy the benefits thereof. Such actions include, without limitation, the use of the Company’s best efforts to cause the nomination and election of the directors as provided above. The Company will not, by any voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be performed hereunder by the Company, but will at all times in good faith assist in the carrying out of all of the provisions of this Agreement and in the taking of all such actions as may be necessary, appropriate or reasonably requested by the holders of a majority of the outstanding voting securities held by the Parties hereto assuming conversion of all outstanding securities in order to protect the rights of the Parties hereunder against impairment.

8. No Liability for Election of Recommended Directors . Neither the Company, the Common Holders, the Investors, nor any officer, director, stockholder, partner, employee or agent of such Party, makes any representation or warranty as to the fitness or competence of the nominee of any Party hereunder to serve on the Company’s Board by virtue of such Party’s execution of this Agreement or by the act of such Party in voting for such nominee pursuant to this Agreement.

9. Grant of Proxy . Should the provisions of this Agreement be construed to constitute the granting of proxies, such proxies shall be deemed coupled with an interest and are irrevocable for the term of this Agreement.

10. Specific Enforcement . It is agreed and understood that monetary damages would not adequately compensate an injured Party for the breach of this Agreement by any Party, that this Agreement shall be specifically enforceable, and that any breach or threatened breach of this Agreement shall be the proper subject of a temporary or permanent injunction or restraining order. Further, each Party hereto waives any claim or defense that there is an adequate remedy at law for such breach or threatened breach.

11. Execution by the Company . The Company, by its execution in the space provided below, agrees that it will cause the certificates evidencing the shares of Common Stock and Preferred Stock to bear the legend required by Section 5 herein, and it shall supply, free of charge, a copy of this Agreement to any holder of a certificate evidencing shares of capital stock of the Company upon written request from such holder to the Company at its principal office. The Parties hereto do hereby agree that the failure to cause the certificates evidencing the shares of Common Stock and Preferred Stock to bear the legend required by Section 5 herein and/or failure of the Company to supply, free of charge, a copy of this Agreement as provided under Section 5 shall not affect the validity or enforcement of this Agreement.

12. Captions . The captions, headings and arrangements used in this Agreement are for convenience only and do not in any way limit or amplify the terms and provisions hereof.

 

6


13. Notices . All notices and other communications given or made pursuant hereto shall be in writing and shall be deemed effectively given upon the earlier to occur of actual receipt or: (a) upon personal delivery to the Party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient; or if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the respective Parties at the addresses set forth on the signature pages attached hereto (or at such other addresses as shall be specified by notice given in accordance with this Section 13).

14. Term . This Agreement shall terminate and be of no further force or effect immediately or on the earlier of (a) the consummation of the Company’s sale of its Common Stock or other securities listed on the Nasdaq National Market or the New York Stock Exchange pursuant to a registration statement on Form S-1 or successor form under the Securities Act of 1933, as amended, (other than a registration statement relating either to sale of securities to employees of the Company pursuant to its stock option, stock purchase or similar plan or a SEC Rule 145 transaction), with a pre-initial public offering valuation of at least $225,000,000 and gross proceeds to the Company of not less than $30,000,000; (b) the date on which a registration statement on Form S-1 registering for re-sale by shareholders of this corporation shares of Common Stock issued upon conversion of the Preferred Stock and, without duplication, shares of Common Stock issued in, or shares of Common Stock issued upon conversion of shares of Preferred Stock issued in, a PIPE Offering (as defined in the Amended and Restated Investors’ Rights Agreement, dated as of the date hereof among the Company and certain of its shareholders) becomes effective; (c) the consummation of a Sale of the Company; or (d) the date specified by written consent or agreement of the holders of a majority of the then outstanding Common Stock held by the Common Holders and the holders of not less than sixty percent (60%) of the then outstanding shares of Preferred Stock.

15. Manner of Voting . The voting of shares pursuant to this Agreement may be effected in person, by proxy, by written consent, or in any other manner permitted by applicable law.

16. Amendments and Waivers . Any term hereof may be amended and the observance of any term hereof may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of (a) the Company, (b) the holders of a majority of the then outstanding Common Stock held by the Common Holders, and (c) the holders of sixty percent (60%) of the then outstanding Preferred Stock held by the Investors; provided, however, that any amendment to clause (y) of the last sentence of Section 6 also shall require the prior written consent of the holders of sixty percent (60%) of the then outstanding Series E Preferred Stock held by the Investors. Any amendment or waiver so effected shall be binding upon the Parties hereto, and all their respective successors and assigns whether or not such party, assignee, or other stockholder entered into or approved such amendment or waiver. The Parties hereby agree and acknowledge that the addition of an additional party pursuant to Section 23 below shall not constitute an amendment or waiver of this Agreement.

 

7


17. Stock Splits, Stock Dividends, etc . In the event of any issuance of shares of the Company’s voting securities hereafter to any of the Parties hereto (including, without limitation, in connection with any stock split, stock dividend, recapitalization, reorganization, or the like), such shares shall become subject to this Agreement and shall be endorsed with the legend set forth in Section 5.

18. Severability . Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

19. Binding Effect . In addition to any restriction or transfer that may be imposed by any other agreement by which any Party hereto may be bound, this Agreement shall be binding upon the Parties, their respective heirs, successors and assigns and to such additional individuals or entities that may become stockholders of the Company and that desire to become Parties hereto; provided that for any such transfer to be deemed effective, the transferee shall have executed and delivered an Adoption Agreement substantially in the form attached hereto as Exhibit C . Upon the execution and delivery of an Adoption Agreement by any transferee reasonably acceptable to the Company, such transferee shall be deemed to be a Party hereto as if such transferee’s signature appeared on the signature pages hereto. By their execution hereof or any Adoption Agreement, each of the Parties hereto appoints the Company as its attorney-in-fact for the purpose of executing any Adoption Agreement which may be required to be delivered hereunder.

20. Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to conflicts of law principles thereof.

21. Entire Agreement and Termination of Prior Agreement . This Agreement is intended to be the sole agreement of the Parties as it relates to this subject matter and does hereby supersede all other agreements of the Parties relating to the subject matter hereof. By execution of this Agreement, the Company, Investors holding at least sixty percent (60%) of the outstanding Preferred Stock held by the Investors and a majority of Common Holders subject to the Prior Agreement acknowledge and agree that the Prior Agreement shall hereby terminate and shall be of no further force and effect and each of the parties thereto shall have no further rights or obligations thereunder.

22. Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

23. Additional Parties .

(a) In the event of a subsequent closing with an investor as provided for in Section 1.3 of the Series E Agreement, such investor shall become a party to this Agreement as an “Investor” upon receipt from such investor of a fully executed signature page hereto.

 

8


(b) If additional parties purchase shares of the Company’s Common Stock (each additional party, a “ New Common Holder ”), including but not limited to, pursuant to the exercise of an option or warrant to purchase shares of Common Stock, then each such New Common Holder may become party to this Agreement as a “Common Holder” hereunder, without the need for any consent, approval or signature of any Investor or Common Holder, when such New Common Holder has both: (i) purchased such shares of Common Stock and paid the Company all consideration payable for such shares and (ii) executed a counterpart signature page to this Agreement. The Company shall require each stockholder owning shares of the Company’s Common Stock, which shares represent in the aggregate at least one percent (1.0%) of the total capital stock of the Company, to become a party to this Agreement as a “Common Holder”. For purposes of this Section 23(b), “total capital stock of the Company” shall include (A) all outstanding shares of the Company’s Common Stock, (B) all shares of Common Stock issuable upon conversion or exercise of all outstanding convertible or exercisable securities of the Company and (C) all shares of Common Stock reserved for issuance pursuant to the Company’s employee stock plans.

24. Arbitration . Any controversy between the Parties hereto involving any claim arising out of or relating to the termination of this Agreement, will be submitted to and be settled by final and binding arbitration in San Francisco, California, in accordance with the then current Commercial Arbitration Rules of the American Arbitration Association (the “ AAA ”), and judgment upon the award rendered by the arbitrators may be entered in any court having jurisdiction thereof. Such arbitration shall be conducted by three (3) arbitrators chosen by the Company, the Investors, and the Common Holders, or failing such agreement, an arbitrator experienced in the sale of similarly-sized companies appointed by the AAA. There shall be limited discovery prior to the arbitration hearing as follows: (a) exchange of witness lists and copies of documentary evidence and documents relating to or arising out of the issues to be arbitrated, (b) depositions of all party witnesses, and (c) such other depositions as may be allowed by the arbitrators upon a showing of good cause. Depositions shall be conducted in accordance with the California Code of Civil Procedure, the arbitrator(s) shall be required to provide in writing to the Parties the basis for the award or order of such arbitrator(s), and a court reporter shall record all hearings, with such record constituting the official transcript of such proceedings.

25. Aggregation of Stock . All shares of the Preferred Stock and Common Stock held or acquired by affiliated entities or persons shall be aggregated together for the purpose of determining the availability of any rights under this Agreement. For purposes of this Agreement, the mutual funds, other pooled vehicles and client accounts on whose behalf the Fidelity Investors (as defined in Section 26) and their respective investment advisory affiliates exercise investment discretion shall be considered affiliates or affiliated entities or persons of such Fidelity Investors and such investment advisory affiliates.

26. Massachusetts Business Trust . A copy of the Agreement and Declaration of Trust of Fidelity Advisor Series I: Fidelity Advisor Dividend Growth Fund, Fidelity Advisor Series VII: Fidelity Advisor Biotechnology Fund, Fidelity Magellan Fund: Fidelity Magellan

 

9


Fund, Fidelity Rutland Square Trust II: Strategic Advisers Core Fund, Fidelity Rutland Square Trust II: Strategic Advisers Core Multi-Manager Fund, Fidelity Securities Fund: Fidelity Dividend Growth Fund, Fidelity Select Portfolios: Biotechnology Portfolio and Variable Insurance Products Fund III: Balanced Portfolio (each, a “ Fidelity Investor ”) (or any affiliate thereof) is on file with the Secretary of the Commonwealth of Massachusetts and notice is hereby given that this Agreement is executed on behalf of the trustees of each such Fidelity Investor or any such affiliate thereof as trustees and not individually and that the obligations of this Agreement are not binding on any of the trustees, officers or stockholders of any such Fidelity Investor or any such affiliate thereof individually but are binding only upon each such Fidelity Investor or any such affiliate thereof and its assets and property.

[Remainder of page intentionally left blank.]

 

10


IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first written above.

 

  KALOBIOS PHARMACEUTICALS, INC.
  /s/ David Pritchard
 

David Pritchard

Chief Executive Officer

Address:   260 East Grand Avenue
  South San Francisco, CA 94080

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:

FIDELITY MAGELLAN FUND:

FIDELITY MAGELLAN FUND

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer
FIDELITY SELECT PORTFOLIOS: BIOTECHNOLOGY PORTFOLIO
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

FIDELITY ADVISOR SERIES VII:

FIDELITY ADVISOR BIOTECHNOLOGY FUND

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
VARIABLE INSURANCE PRODUCTS
FUND III: BALANCED PORTFOLIO
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer
FIDELITY ADVISOR SERIES I: FIDELITY ADVISOR DIVIDEND GROWTH FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer
FIDELITY SECURITIES FUND: FIDELITY DIVIDEND GROWTH FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
FIDELITY RUTLAND SQUARE TRUST II: STRATEGIC ADVISERS CORE MULTI-MANAGER FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer
FIDELITY RUTLAND SQUARE TRUST II: STRATEGIC ADVISERS CORE FUND
By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

Address for Notices:   Andrew Boyd
    Fidelity Investments
  82 Devonshire Street,
  V13H
  Boston, MA 02109
  Tel: 617-563-5144
  Fax: 617-385-2818

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS :
Mitsubishi UFJ Capital II, Limited partnership
by:   Mitsubishi UFJ Capital its General Partner
By:   /s/ Yoshihiro Hashimoto
Name:   Yoshihiro Hashimoto
Title:   President
Address:   1-7-17 Nihonbashi, Chuo-ku
 

            Tokyo, 103-0027, Japan

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
GENZYME CORPORATION
By: /s/ David Meeker                                                   
Name: David Meeker
Title: President and Chief Executive Officer
Address:   Genzyme Corporation
 

500 Kendall Street

 

Cambridge, MA 02142

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
MPM BIOVENTURES III, L.P.
By:  

MPM BioVentures III GP, L.P.,

its General Partner

By:  

MPM BioVentures III LLC,

its General Partner

By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

MPM BIOVENTURES III-QP, L.P.
By:   MPM BioVentures III GP, L.P., its General Partner
By:   MPM BioVentures III LLC, its General Partner
By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

MPM BIOVENTURES III GMBH & CO.

BETEILIGUNGS KG

By:   MPM BioVentures III GP, L.P., in its capacity as the Managing Limited Partner
By:   MPM BioVentures III LLC, its General Partner
By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:

MPM BIOVENTURES III PARALLEL

FUND, L.P.

By:  

MPM BioVentures III GP, L.P.,

its General Partner

By:  

MPM BioVentures III LLC,

its General Partner

By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

MPM ASSET MANAGEMENT

INVESTORS 2005 BVIII LLC

By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Manager

 

MPM BIOVENTURES STRATEGIC FUND,

L.P.

By:  

MPM BioVentures III GP, L.P.,

its General Partner

By:  

MPM BioVentures III LLC,

its General Partner

By:   /s/ Dennis Henner
Name:   Dennis Henner
Title:   Series A Member

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
S OFINNOVA V ENTURE P ARTNERS V, LP
By:  

Sofinnova Management V 2005, LLC

Its General Partner

By:   /s/ James I. Healy
  James I. Healy, Managing Director

 

S OFINNOVA V ENTURE A FFILIATES V, LP
By:  

Sofinnova Management V, LLC

Its General Partner

By:   /s/ James I. Healy
  James I. Healy, Managing Director

 

S OFINNOVA V ENTURE P RINCIPALS V, LP
By:  

Sofinnova Management V, LLC

Its General Partner

By:   /s/ James I. Healy
  James I. Healy, Managing Director

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


  INVESTORS:
 

ALLOY PARTNERS 2000, L.P.

ALLOY VENTURES 2000, L.P.

ALLOY CORPORATE 2000, L.P.

ALLOY INVESTORS 2000, L.P.

ALLOY ANNEX I, L.P.

  /s/ [Illegible]
 

By: Alloy Ventures 2000, LLC,

        its General Partner

Address:

 

480 Cowper Street, 2 nd Floor

Palo Alto, CA 94301

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


  INVESTORS :
  5AM VENTURES LLC
  By:   /s/ [Illegible]
  Name:  
  Title:  
Address:  

2200 Sand Hill Road, Suite 110

Menlo Park, CA 94025

  5AM CO-INVESTORS LLC
  By:   /s/ [Illegible]
  Name:  
  Title:  
Address:  

2200 Sand Hill Road, Suite 110

Menlo Park, CA 94025

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
INVESTORS:
LB I GROUP INC.
By:   /s/ Ashvin Rao
Name:   Ashvin Rao
Title:   Vice President

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:

 

Signed for and on behalf of GBS Venture Partners
Limited (ABN 54 072 515 247) in
its capacity as trustee of GBS BioVentures II
/s/ Brigitte Smith     /s/ Geoff Brooke  
Director     Director  
Brigitte Smith     Geoff Brooke  
Name     Name  
Signed for and on behalf of GBS Venture Partners Limited (ABN 54 072 515 247) in its capacity as trustee of the Genesis Fund
/s/ Brigitte Smith     /s/ Geoff Brooke  
Director     Director  
Brigitte Smith     Geoff Brooke  
Name     Name  

Address:

 

    Level 5, 71 Collins St.

    Melbourne Vic, Australia

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
G&H PARTNERS
By:   /s/ Jonathan Gleason
Name:   Jonathan Gleason
Title:    
Address:  

c/o Gunderson Dettmer

1200 Seaport Blvd.

Redwood City, CA 94063

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


INVESTORS:
BAXTER INTERNATIONAL INC.
By:   /s/ Michael Baughman
Name:   Michael Baughman
Title:   CVP Controller
Address:  

One Baxter Parkway

Deerfield, IL 60015-4625

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


COMMON HOLDERS:
/s/ Dan Shochat
Dan Shochat
/s/ Geoffrey Yarranton
Geoffrey Yarranton
/s/ David Pritchard
David Pritchard

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


EXHIBIT A

GBS Venture Partners Limited, as trustee of the Bioscience Ventures II Fund and the Genesis

Fund

Lotus BioScience Investment Holdings Ltd.

5AM Investors, LLC

5AM Co-Investors, LLC

Singapore Bio-Innovations Pte Ltd.

Sofinnova Venture Partners V, LP

Sofinnova Ventures Affiliates V, LP

Sofinnova Venture Principals V, LP

Alloy Partners 2000, L.P.

Alloy Ventures 2000, L.P.

Alloy Corporate 2000, L.P.

Alloy Investors 2000, L.P.

Alloy Annex I, L.P.

Robert Balint

James Larrick

MPM BioVentures III, L.P.

MPM BioVentures III-QP, L.P.

MPM BioVentures III GmbH & Co. Beteiligungs KG

MPM BioVentures III Parallel Fund, L.P.

MPM Asset Management Investors 2005 BVIII LLC

MPM BioVentures Strategic Fund, L.P.

Howard Baer

Stuart E. Builder

George Sachs

LB I Group Inc.

Mitsubishi UFJ Capital II, Limited partnership

Genzyme Corporation

G&H Partners

Montgomery & Co., LLC

Baxter International Inc.

Development Bank of Japan

Fidelity Advisor Series I: Fidelity Advisor Dividend Growth Fund

Fidelity Advisor Series VII: Fidelity Advisor Biotechnology Fund

Fidelity Magellan Fund: Fidelity Magellan Fund

Fidelity Rutland Square Trust II: Strategic Advisers Core Fund

Fidelity Rutland Square Trust II: Strategic Advisers Core Multi-Manager Fund

Fidelity Securities Fund: Fidelity Dividend Growth Fund

Fidelity Select Portfolios: Biotechnology Portfolio

Variable Insurance Products Fund III: Balanced Portfolio


EXHIBIT B

Robert F. Balint, PhD

Geoffrey Yarranton

Dan Shochat

David Pritchard

5AM Ventures LLC

5AM Co-Investors LLC

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT


EXHIBIT C

ADOPTION AGREEMENT

This Adoption Agreement (“ Adoption Agreement ”) is executed by the undersigned (the “ Transferee ”) pursuant to the terms of that certain Amended and Restated Voting Agreement dated as of May 2, 2012 (the “ Agreement ”) by and among the Company and certain of its Stockholders. Capitalized terms used but not defined herein shall have the respective meanings ascribed to such terms in the Agreement. By the execution of this Adoption Agreement, the Transferee agrees as follows:

(a) Acknowledgment . Transferee acknowledges that Transferee is acquiring certain shares of the capital stock of the Company (the “ Stock ”), subject to the terms and conditions of the Agreement.

(b) Agreement . Transferee (i) agrees that the Stock acquired by Transferee shall be bound by and subject to the terms of the Agreement, and (ii) hereby adopts the Agreement with the same force and effect as if Transferee were originally a Party thereto.

(c) Notice . Any notice required or permitted by the Agreement shall be given to Transferee at the address listed beside Transferee’s signature below.

EXECUTED AND DATED this             day of                     ,             .

 

  TRANSFEREE:
  By:    
    Name and Title
Address:    
   
Fax:    

 

Accepted and Agreed:
KALOBIOS PHARMACEUTICALS, INC
By:    
Name:    
Title:    

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED & RESTATED VOTING AGREEMENT

Exhibit 10.10

AMENDED AND RESTATED

RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT

This AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT is entered into as of May 2, 2012 by and among KaloBios Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and David Pritchard, Geoffrey Yarranton, Dan Shochat, 5AM Ventures LLC, and 5AM Co-Investors LLC (each a “ Key Common Holder ” and together the “ Key Common Holders ”) and the parties listed on Exhibit A (the “ Purchasers ”) who are holders of the Company’s Series A Preferred Stock (the “ Series A Stock ”), the Company’s Series B-1 Preferred Stock (the “ Series B-1 Stock ”), the Company’s Series B-2 Preferred Stock (the “ Series B-2 Stock ”), the Company’s Series C Preferred Stock (the “ Series C Stock ”), the Company’s Series D Preferred Stock (the “ Series D Stock ”) and/or the Company’s Series E Preferred Stock (the “ Series E Stock ” and, together with the Series A Stock, the Series B-1 Stock the Series B-2 Stock, the Series C Stock and the Series D Stock, the “ Preferred Shares ”).

W I T N E S S E T H :

WHEREAS, the Company and certain of the Purchasers (the “ New Purchasers ”) are parties to the Series E Preferred Stock Purchase Agreement of even date herewith (the “ Series E Agreement ”), pursuant to which the New Purchasers are purchasing shares of the Company’s Series E Stock;

WHEREAS, each Key Common Holder is the beneficial owner of the number of shares of Common Stock of the Company set forth opposite his or her name on Exhibit B hereto;

WHEREAS, the Company, each Key Common Holder and certain of the Purchasers (the “ Existing Purchasers ”) are parties to that certain Amended and Restated Right of First Refusal and Co-Sale Agreement, dated as of September 22, 2008 (the “ Prior Agreement ”); and

WHEREAS, the Company, each Key Common Holder and the Existing Purchasers wish to provide further inducement to the New Purchasers to purchase Series E Stock by amending and restating the Prior Agreement to include the New Purchasers and to amend and restate the rights and obligations set forth therein, in each case as set forth herein.

NOW, THEREFORE, in consideration of the foregoing premises and certain other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

1. Restrictions on Transfer of Shares by Key Common Holders . Except as otherwise provided in this Agreement, each Key Common Holder will not sell, assign, transfer, pledge, hypothecate, or otherwise encumber or dispose of in any way, all or any part of or any interest in the Equity Securities (as defined below) now or hereafter owned or held by such Key Common Holder. Any sale, assignment, transfer, pledge, hypothecation or other encumbrance or disposition of Equity Securities (as defined below) not made in conformance with this Agreement shall be null and void, shall not be recorded on the books of the Company and shall not be recognized by the Company.


2. Definitions .

(a) Equity Securities . For purposes of this Agreement, the term “ Equity Securities ” shall mean any securities having voting rights in the election of the Board of Directors of the Company not contingent upon default, or any securities evidencing an ownership interest in the Company, or any securities convertible into or exercisable for any shares of the foregoing, or any agreement or commitment to issue any of the foregoing. Notwithstanding the foregoing, with respect to 5AM Ventures LLC and 5AM Co-Investors LLC, the definition of Equity Securities shall only include an aggregate of 564,915 shares of Common Stock (as adjusted for stock splits, reverse stock splits and the like effected after the date of this Agreement).

(b) Holders . For purposes of this Agreement, the term “ Holders ” shall mean the Purchasers or persons who have acquired shares from any of such persons or their transferees or assignees in accordance with the provisions of this Agreement.

3. Agreements Among the Company, the Purchasers and the Key Common Holders .

3.1 Rights of Refusal .

(a) Contingent Offer Notice and Firm Offer Notice . Subject to the Company’s right of first refusal, if at any time any Key Common Holder proposes to transfer at least 20,000 shares of Equity Securities to one or more third parties pursuant to an understanding with such third parties (a “ Transfer ”), then the Key Common Holder shall give the Company and each Holder written notice of the Key Common Holder’s intention to make the Transfer (the “ Contingent Offer Notice ”), which Contingent Offer Notice shall include (i) a description of the Equity Securities to be transferred (“ Total Offered Shares ”), (ii) the identity of the prospective transferee(s) and (iii) the consideration and the material terms and conditions upon which the proposed Transfer is to be made. The Contingent Offer Notice shall certify that the Key Common Holder has received a firm offer from the prospective transferee(s) and in good faith believes a binding agreement for the Transfer is obtainable on the terms set forth in the Contingent Offer Notice. The Contingent Offer Notice shall also include a copy of any written proposal, term sheet or letter of intent or other agreement relating to the proposed Transfer. If the Company’s right of first refusal period has lapsed (thirty (30) days after receipt of the Contingent Offer Notice by the Company) and not all the Total Offered Shares were purchased by the Company, the Key Common Holder shall immediately give each Holder written notice of the remaining shares (“ Firm Offer Notice ”), which Firm Offer Notice shall include (i) all the required items from the Contingent Offer Notice and (ii) the number of Total Offered Shares that were not purchased by the Company (“ Offered Shares ”).

(b) Holders’ Option . The Holders shall have an option for a period of twenty (20) days from the Holder’s receipt of the Firm Offer Notice from the Key Common Holder set forth in Section 3.1(a) to elect to purchase their respective pro rata shares of the

 

2


Offered Shares at the same price and subject to the same material terms and conditions as described in the Firm Offer Notice. Each Holder may exercise such purchase option and, thereby, purchase all or any portion of his, her or its pro rata share (with any re-allotments as provided below) of the Offered Shares, by notifying the Key Common Holder and the Company in writing, before expiration of the twenty (20) day period as to the number of such shares which he, she or it wishes to purchase (including any re-allotment). Each Holder’s pro rata share of the Offered Shares shall be a fraction of the Offered Shares, of which the number of shares of Common Stock (including shares of Common Stock issuable upon conversion of Preferred Shares) owned by such Holder on the date of the Firm Offer Notice shall be the numerator and the total number of shares of Common Stock (including shares of Common Stock issuable upon conversion of Preferred Shares) held by all Holders on the date of the Firm Offer Notice shall be the denominator. Each Holder electing to exercise the right to purchase its full pro rata shares of the Offered Shares (a “ Participating Holder ”) shall have a right of reallotment such that, if any other Holder fails to exercise the right to purchase its full pro rata share of the Offered Shares, each such Participating Holder may exercise an additional right to purchase all or any portion of his, her or its pro rata share of the Offered Shares not previously purchased such that each Participating Holder will have a right to take up to 100% of any such remaining Offered Shares, regardless of whether his, her or its pro rata ownership in the Company is modified as a result of his, her or its exercise of this right of first refusal. For the purpose of the preceding sentence, each Participating Holder’s pro rata share shall be a fraction of the Offered Shares previously not purchased, the numerator of which shall be the number of shares of Common Stock (including shares of Common Stock issuable upon conversion of Preferred Shares) held by such Participating Holder on the date of the Firm Offer Notice and the denominator which shall be the total number of shares of Common Stock (including shares of Common Stock issuable upon conversion of Preferred Shares) held by all Participating Holders on the date of the Firm Offer Notice. Each Holder shall be entitled to apportion Offered Shares to be purchased among its partners and affiliates, provided that such Holder notifies the Key Common Holder of such allocation. If a Holder gives the Key Common Holder notice that it desires to purchase its pro rata share of the Offered Shares and, as the case may be, its reallotment, then payment for the Offered Shares shall be by check or wire transfer, against delivery of the Offered Shares to be purchased at a place agreed upon between the parties and at the time of the scheduled closing therefor, which shall be no later than forty-five (45) days after the Holder’s receipt of the Firm Offer Notice, unless the Firm Offer Notice contemplated a later closing with the prospective third party transferee(s) or unless the value of the purchase price has not yet been established pursuant to Section 3.1(c).

(c) Valuation of Property . Should the purchase price specified in the Contingent Offer Notice or Firm Offer Notice be payable in property other than cash or evidences of indebtedness, the Company (or the Holders) shall have the right to pay the purchase price in the form of cash equal in amount to the value of such property. If the Key Common Holder and the Holders cannot agree on such cash value within ten (10) days after the Holders’ receipt of the Contingent Offer Notice, the valuation shall be made by an appraiser of recognized standing selected by the Key Common Holder and the Holders or, if they cannot agree on an appraiser within twenty (20) days after the Holder’s receipt of the Contingent Offer Notice, each shall select an appraiser of recognized standing and the two appraisers shall designate a third appraiser of recognized standing, whose appraisal shall be determinative of such value. The cost of such appraisal shall be shared equally by the Key Common Holder and the Holders, with the

 

3


half of the cost borne by the Holders borne pro rata by each based on the number of shares such parties were interested in purchasing pursuant to this Section 3. If the time for the closing of the Company’s purchase or the Holders’ purchase has expired but for the determination of the value of the purchase price offered by the prospective transferee(s), then such closing shall be held on or prior to the fifth business day after such valuation shall have been made pursuant to this subsection.

3.2 Right of Co-Sale .

(a) To the extent that (i) the Company has not exercised its right to purchase the offered shares pursuant to any right of first refusal held by the Company and (ii) the Holders have not exercised their rights to purchase the Offered Shares pursuant to Section 3.1, then each Holder (a “ Selling Holder ” for purposes of this subsection 3.2) which notifies the Key Common Holder in writing within thirty (30) days after receipt of the Firm Offer Notice referred to in Section 3.1(a), shall have the right to participate in such sale of Equity Securities on the same terms and conditions as specified in the Firm Offer Notice. Such Selling Holder’s notice to the Key Common Holder shall indicate the number of shares of Equity Securities the Selling Holder wishes to sell under his, her or its right to participate. To the extent one or more of the Holders exercise such right of participation in accordance with the terms and conditions set forth below, the number of shares of Equity Securities that the Key Common Holder may sell in the Transfer shall be correspondingly reduced.

(b) Each Selling Holder may sell all or any part of that number of shares of Equity Securities equal to the product obtained by multiplying (i) the aggregate number of shares of Equity Securities covered by the Firm Offer Notice by (ii) a fraction, the numerator of which is the number of shares of Common Stock (including shares of Common Stock issuable upon conversion of Preferred Shares) owned by the Selling Holder on the date of the Firm Offer Notice and the denominator of which is the total number of shares of Common Stock (including shares of Common Stock issuable upon conversion of Preferred Shares) owned by the Key Common Holder and all of the Selling Holders on the date of the Firm Offer Notice.

(c) Each Selling Holder shall effect its participation in the sale by promptly delivering to the Key Common Holder for transfer to the prospective purchaser one or more certificates, properly endorsed for transfer, which represent:

(i) the type and number of shares of Equity Securities which such Selling Holder elects to sell; or

(ii) that number of shares of Equity Securities which are at such time convertible into the number of shares of Common Stock which such Selling Holder elects to sell; provided, however, that if the prospective third-party purchaser objects to the delivery of Equity Securities in lieu of Common Stock, such Selling Holder shall convert such Equity Securities into Common Stock and deliver Common Stock as provided in this Section 3.2. The Company agrees to make any such conversion concurrent with the actual transfer of such shares to the purchaser and contingent on such transfer.

 

4


(d) The stock certificate or certificates that the Selling Holder delivers to the Key Common Holder pursuant to Section 3.2(c) shall be transferred to the prospective purchaser in consummation of the sale of the Equity Securities pursuant to the terms and conditions specified in the Firm Offer Notice, and the Key Common Holder shall concurrently therewith remit to such Selling Holder that portion of the sale proceeds to which such Selling Holder is entitled by reason of its participation in such sale. To the extent that any prospective purchaser or purchasers prohibits such assignment or otherwise refuses to purchase shares or other securities from a Selling Holder exercising its rights of co-sale hereunder, the Key Common Holder shall not sell to such prospective purchaser or purchasers any Equity Securities unless and until, simultaneously with such sale, the Key Common Holder shall purchase such shares or other securities from such Selling Holder for the same consideration and on the same terms and conditions as the proposed transfer described in the Firm Offer Notice.

3.3 Non-Exercise of Rights . To the extent that the Company has not exercised its right to purchase the offered shares pursuant to any right of first refusal held by the Company and the Holders have not exercised their rights to purchase the Offered Shares within the time periods specified in Section 3.1 and the Holders have not exercised their rights to participate in the sale of the Offered Shares within the time periods specified in Section 3.2, the Key Common Holder shall have a period of thirty (30) days from the expiration of such rights in which to sell the Offered Shares upon terms and conditions (including the purchase price) no more favorable than those specified in the Firm Offer Notice to the third-party transferee(s) identified in the Firm Offer Notice. The third-party transferee(s) shall acquire the Offered Shares free and clear of subsequent rights of first refusal and co-sale rights under this Agreement. In the event the Key Common Holder does not consummate the sale or disposition of the Offered Shares within the thirty (30) day period from the expiration of these rights, the Holders’ first refusal rights and co-sale rights shall continue to be applicable to any subsequent disposition of the Offered Shares by the Key Common Holder until such right lapses in accordance with the terms of this Agreement. Furthermore, the exercise or non-exercise of the rights of the Holders under this Section 3 to purchase Equity Securities from the Key Common Holder or participate in sales of Equity Securities by the Key Common Holder shall not adversely affect their rights to make subsequent purchases from the Key Common Holder of Equity Securities or subsequently participate in sales of Equity Securities by the Key Common Holder.

3.4 Limitations to Rights of Refusal and Co-Sale . Notwithstanding the provisions of Section 3.1 and 3.2 of this Agreement, the Key Common Holder may sell or otherwise assign, with or without consideration, Equity Securities to any spouse or member of the Key Common Holder’s immediate family, or to a custodian, trustee (including a trustee of a voting trust), executor, or other fiduciary for the account of the Key Common Holder’s spouse or members of the Key Common Holder’s immediate family, or to a trust for the Key Common Holder’s own self, or a charitable remainder trust, provided that each such transferee or assignee, prior to the completion of the sale, transfer, or assignment shall have executed documents assuming the obligations of the Key Common Holder under this Agreement with respect to the transferred securities. In addition, notwithstanding the provisions of Section 3.1 and 3.2 of this Agreement, 5AM Ventures LLC and 5AM Co-Investors LLC may sell or otherwise assign, with or without consideration, Equity Securities to (i) Aravis Venture, L.P., (ii) The Bay City Capital Fund, L.P. and (iii) Versant Venture Capital, L.P. (each a “ Member ”), so long as prior to the completion of the sale, transfer, or assignment (a) such Member is a stockholder of the Company and (b) such Member shall have executed documents assuming the obligations of a Key Common Holder under this Agreement with respect to the transferred Equity Securities.

 

5


3.5 Prohibited Transfers .

(a) In the event the Key Common Holder should sell any Equity Securities in contravention of the co-sale rights of the Holders under Section 3.2 (a “ Prohibited Transfer ”), the Holders, in addition to such other remedies as may be available at law, in equity or hereunder, shall have the put option provided below, and the Key Common Holder shall be bound by the applicable provisions of such option.

(b) In the event of a Prohibited Transfer, each Holder shall have the right to sell to the Key Common Holder the type and number of shares of Equity Securities equal to the number of shares each Holder would have been entitled to transfer to the third-party transferee(s) under Section 3.2 hereof had the Prohibited Transfer been effected pursuant to and in compliance with the terms hereof. Such sale shall be made on the following terms and conditions:

(i) The price per share at which the shares are to be sold to the Key Common Holder shall be equal to the price per share paid by the third-party transferee(s) to the Key Common Holder in the Prohibited Transfer. The Key Common Holder shall also reimburse each Holder for any and all fees and expenses, including legal fees and expenses, incurred pursuant to the exercise or the attempted exercise of the Holder’s rights under Section 3.

(ii) Within ninety (90) days after the later of the dates on which the Holder (A) receives notice of the Prohibited Transfer or (B) otherwise becomes aware of the Prohibited Transfer, each Holder shall, if exercising the option created hereby, deliver to the Key Common Holder the certificate or certificates representing shares to be sold, each certificate to be properly endorsed for transfer.

(iii) The Key Common Holder shall, upon receipt of the certificate or certificates for the shares to be sold by a Holder, pursuant to this Section 3.5, pay the aggregate purchase price therefor and the amount of reimbursable fees and expenses, as specified in subparagraph 3.5(b)(i), in cash or by other means acceptable to the Holder.

(iv) Notwithstanding the foregoing, any attempt by the Key Common Holder to transfer Equity Securities in violation of Section 3 hereof shall be void and the Company agrees it will not effect such a transfer nor will it treat any alleged transferee(s) as the holder of such shares without the written consent of a majority in interest of the Holders.

4. Assignments and Transfers; No Third Party Beneficiaries . This Agreement and the rights and obligations of the parties hereunder shall inure to the benefit of, and be binding upon, their respective successors, assigns and legal representatives, but shall not otherwise be for the benefit of any third party. The rights of the Holders hereunder are only assignable (i) by each of such Holders to any other Holder, (ii) to a partner or affiliate of such Holder or (iii) to an assignee or transferee who acquires all of the Equity Securities purchased by a Holder or at least 250,000 shares of Common Stock (including shares of Common Stock issuable upon conversion of Preferred Shares).

 

6


5. Legend . Each existing or replacement certificate for shares now owned or hereafter acquired by the Key Common Holder shall bear the following legend upon its face:

“THE SALE, PLEDGE, HYPOTHECATION, ASSIGNMENT OR TRANSFER OF THE SECURITIES REPRESENTED BY THIS CERTIFICATE IS SUBJECT TO THE TERMS AND CONDITIONS OF A CERTAIN RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT BY AND BETWEEN THE STOCKHOLDER, THE CORPORATION AND CERTAIN HOLDERS OF STOCK OF THE CORPORATION. COPIES OF SUCH AGREEMENT MAY BE OBTAINED UPON WRITTEN REQUEST TO THE SECRETARY OF THE CORPORATION.”

6. Effect of Change in Company’s Capital Structure . Appropriate adjustments shall be made in the number and class of shares in the event of a stock dividend, stock split, reverse stock split, combination, reclassification or like change in the capital structure of the Company.

7. Notices . All notices and other communications given or made pursuant hereto shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient; if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. The occurrence of the events set forth in clauses (a) through (d) above shall constitute “ Delivery ” of notice. All notices and other communications shall be sent to the Company at 260 East Grand Avenue, South San Francisco, CA 94080, Attention: Chief Executive Officer and to the other parties at the addresses set forth on the Schedule A or Schedule B , as applicable (or at such other addresses as shall be specified by notice given in accordance with this Section 7).

8. Further Instruments and Actions . The parties agree to execute such further instruments and to take such further action as may reasonably be necessary to carry out the intent of this Agreement. The Key Common Holders agree to cooperate affirmatively with the Company, the Purchasers and the Holders, to the extent reasonably requested by the Company, the Purchasers or the Holders, to enforce rights and obligations pursuant hereto.

9. Term . This Agreement shall terminate and be of no further force or effect upon the earlier of (i) the closing of a firm commitment underwritten public offering pursuant to an effective registration statement on Form S-1 or successor form under the Securities Act of 1933, as amended, covering the offer and sale of the Company’s Common Stock with a pre-initial public offering valuation of at least $225,000,000 and gross proceeds to the Company of not less than $30,000,000; (ii) the date on which a registration statement on Form S-1 registering for re-sale by shareholders of this corporation shares of Common Stock issued upon conversion of the Preferred Stock and, without duplication, shares of Common Stock issued in, or shares of Common Stock issued upon conversion of Preferred Stock issued in, a PIPE Offering (as defined in the Amended and Restated Investors’ Rights Agreement, dated as of the date hereof among

 

7


the Company and certain of its shareholders) becomes effective, (iii) the closing of a Liquidation Event (as defined in the Company’s Amended and Restated Certificate of Incorporation filed on or about the date hereof), unless the treatment of such transaction as a Liquidation Event has been waived in accordance with such Amended and Restated Certificate of Incorporation; or (iv) the date specified by written consent or agreement of the holders of not less than sixty percent (60%) of the then outstanding Preferred Shares.

10. Entire Agreement . This Agreement contains the entire understanding of the parties hereto with respect to the subject matter hereof, supersedes all other agreements between or among any of the parties with respect to the subject matter hereof. To the extent this Agreement conflicts with a provision from the Prior Agreement, this Agreement expressly supercedes and replaces such provisions. This Agreement shall be interpreted under the laws of the State of California without reference to California conflicts of law provisions.

11. Amendments and Waivers . Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of (i) the Company, (ii) the written consent of the holders of more than fifty percent (50%) of the Common Stock held by Key Common Holders and (iii) the written consent of the holders of more than sixty percent (60%) of the then outstanding Preferred Shares; provided, however, that any amendment or waiver that adversely and disproportionately affects the rights, powers and privileges hereunder in respect of the Series E Preferred Stock in a manner different from the other series of Preferred Stock shall require the prior written consent of the holders of more than sixty percent (60%) of the then outstanding shares of Series E Preferred Stock. Any amendment or waiver effected in accordance with this paragraph shall be binding upon the Key Common Holders and all Holders and their respective successors and assigns. The parties hereby agree and acknowledge that the addition of an additional party pursuant to Section 15 below shall not constitute an amendment or waiver of this Agreement.

12. Separability . In case any provision of the Agreement shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

13. Attorney’s Fees . In the event that any dispute among the parties to this Agreement should result in litigation, the prevailing party in such dispute shall be entitled to recover from the losing party all fees, costs and expenses of enforcing any right of such prevailing party under or with respect to this Agreement, including without limitation, such reasonable fees and expenses of attorneys and accountants, which shall include, without limitation, all fees, costs and expenses of appeals.

14. Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

8


15. Additional Parties .

15.1 In the event of a subsequent closing with an investor as provided for in Section 1.3 of the Series E Agreement, such investor shall become a party to this Agreement as a “Purchaser” upon receipt from such investor of a fully executed signature page hereto.

15.2 If additional parties purchase shares of Equity Securities (each additional party, a “ New Key Common Holder ”), including but not limited to, pursuant to the exercise of an option or warrant to purchase shares of Equity Securities, then each such New Key Common Holder may become party to this Agreement as a “Key Common Holder” hereunder, without the need for any consent, approval or signature of any Holder or Key Common Holder, when such New Key Common Holder has both: (a) purchased such shares of Equity Securities and paid the Company all consideration payable for such shares and (b) executed a counterpart signature page to this Agreement. The Company shall require each stockholder owning shares of the Company’s Common Stock, which shares represent in the aggregate at least one percent (1.0%) of the total capital stock of the Company, to become a party to this Agreement as a “Key Common Holder”. For purposes of this Section 15.2, “total capital stock of the Company” shall include (i) all outstanding shares of the Company’s Common Stock, (ii) all shares of Common Stock issuable upon conversion or exercise of all outstanding convertible or exercisable securities of the Company and (iii) all shares of Common Stock reserved for issuance pursuant to the Company’s employee stock plans.

16. Termination of Prior Agreement . Upon the effectiveness of this Agreement, the Prior Agreement shall terminate and be of no further force and effect, and shall be superseded and replaced in its entirety by this Agreement.

17. Aggregation of Stock . All shares of the Preferred Stock and Common Stock held or acquired by affiliated entities or persons shall be aggregated together for the purpose of determining the availability of any rights under this Agreement. For purposes of this Agreement, the mutual funds, other pooled vehicles and client accounts on whose behalf the Fidelity Investors (as defined in Section 18) and their respective investment advisory affiliates exercise investment discretion shall be considered affiliates or affiliated entities or persons of such Fidelity Investors and such investment advisory affiliates.

 

9


18. Massachusetts Business Trust . A copy of the Agreement and Declaration of Trust of Fidelity Advisor Series I: Fidelity Advisor Dividend Growth Fund, Fidelity Advisor Series VII: Fidelity Advisor Biotechnology Fund, Fidelity Magellan Fund: Fidelity Magellan Fund, Fidelity Rutland Square Trust II: Strategic Advisers Core Fund, Fidelity Rutland Square Trust II: Strategic Advisers Core Multi-Manager Fund, Fidelity Securities Fund: Fidelity Dividend Growth Fund, Fidelity Select Portfolios: Biotechnology Portfolio and Variable Insurance Products Fund III: Balanced Portfolio (each, a “ Fidelity Investor ”) (or any affiliate thereof) is on file with the Secretary of the Commonwealth of Massachusetts and notice is hereby given that this Agreement is executed on behalf of the trustees of each such Fidelity Investor or any such affiliate thereof as trustees and not individually and that the obligations of this Agreement are not binding on any of the trustees, officers or stockholders of any such Fidelity Investor or any such affiliate thereof individually but are binding only upon each such Fidelity Investor or any such affiliate thereof and its assets and property.

[Remainder of page intentionally left blank.]

 

10


IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first written above.

 

  KALOBIOS PHARMACEUTICALS, INC.
  /s/ David Pritchard
  David Pritchard
  Chief Executive Officer
Address:  

260 East Grand Avenue

South San Francisco, CA 94080

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


KEY COMMON HOLDERS:
/s/ Dan Shochat
Dan Shochat

 

/s/ Geoffrey Yarranton
Geoffrey Yarranton

/s/ David Pritchard

David Pritchard

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


 

KEY COMMON HOLDERS / PURCHASERS

 

5AM VENTURES LLC

  By:   /s/ [Illegible]
  Name:    
  Title:    
Address:  

2200 Sand Hill Road, Suite 110

Menlo Park, CA 94025

  5AM CO-INVESTORS LLC
  By:   /s/ [Illegible]
  Name:    
  Title:    
Address:  

2200 Sand Hill Road, Suite 110

Menlo Park, CA 94025

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


PURCHASERS:

 

FIDELITY MAGELLAN FUND:

FIDELITY MAGELLAN FUND

 

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY SELECT PORTFOLIOS:

BIOTECHNOLOGY PORTFOLIO

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY ADVISOR SERIES VII:

FIDELITY ADVISOR BIOTECHNOLOGY FUND

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


PURCHASERS:

 

VARIABLE INSURANCE PRODUCTS

FUND III: BALANCED PORTFOLIO

 

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY ADVISOR SERIES I:

FIDELITY ADVISOR DIVIDEND

GROWTH FUND

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

FIDELITY SECURITIES FUND:

FIDELITY DIVIDEND GROWTH FUND

By:   /s/ Adrien Deberghes
Name:   Adrien Deberghes
Title:   Deputy Treasurer

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


  PURCHASERS:
 

FIDELITY RUTLAND SQUARE TRUST II:

STRATEGIC ADVISERS CORE

MULTI-MANAGER FUND

  By:  

/s/ Adrien Deberghes

  Name:   Adrien Deberghes
  Title:   Deputy Treasurer
 

FIDELITY RUTLAND SQUARE TRUST II:

STRATEGIC ADVISERS CORE FUND

  By:  

/s/ Adrien Deberghes

  Name:   Adrien Deberghes
  Title:   Deputy Treasurer
Address for Notices:   Andrew Boyd
  Fidelity Investments
  82 Devonshire Street, V13H
  Boston, MA 02109
  Tel: 617-563-5144
  Fax: 617-385-2818

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


PURCHASERS :
LB I GROUP INC.
By:   /s/ Ashvin Rao
 

 

Name:   Ashvin Rao
Title:   Vice President

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


PURCHASERS :
MPM BIOVENTURES III, L.P.
By:   MPM BioVentures III GP, L.P.,
  its General Partner
By:   MPM BioVentures III LLC,
  its General Partner
By:  

/s/ Dennis Henner

Name:   Dennis Henner
Title:   Series A Member
MPM BIOVENTURES III-QP, L.P.
By:   MPM BioVentures III GP, L.P.,
  its General Partner
By:   MPM BioVentures III LLC,
  its General Partner
By:  

/s/ Dennis Henner

Name:   Dennis Henner
Title:   Series A Member
MPM BIOVENTURES III GMBH & CO. BETEILIGUNGS KG
By:   MPM BioVentures III GP, L.P., in its capacity as the Managing Limited Partner
By:   MPM BioVentures III LLC,
  its General Partner
By:  

/s/ Dennis Henner

Name:   Dennis Henner
Title:   Series A Member

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


PURCHASERS:
MPM BIOVENTURES III PARALLEL FUND, L.P.
By:   MPM BioVentures III GP, L.P.,
  its General Partner
By:   MPM BioVentures III LLC,
  its General Partner
By:  

/s/ Dennis Henner

Name:   Dennis Henner
Title:   Series A Member
MPM ASSET MANAGEMENT INVESTORS 2005 BVIII LLC
By:  

/s/ Dennis Henner

Name:   Dennis Henner
Title:   Manager
MPM BIOVENTURES STRATEGIC FUND, L.P.
By:   MPM BioVentures III GP, L.P.,
  its General Partner
By:   MPM BioVentures III LLC,
  its General Partner

 

By:  

/s/ Dennis Henner

Name:   Dennis Henner
Title:   Series A Member

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


PURCHASERS:
S OFINNOVA V ENTURE P ARTNERS V, LP
By:   Sofinnova Management V 2005, LLC
  Its General Partner
By:  

/s/ James I. Healy

  James I. Healy, Managing Director
S OFINNOVA V ENTURE A FFILIATES V, LP
By:   Sofinnova Management V, LLC
  Its General Partner
By:  

/s/ James I. Healy

  James I. Healy, Managing Director
S OFINNOVA V ENTURE P RINCIPALS V, LP
By:   Sofinnova Management V, LLC
  Its General Partner
By:  

/s/ James I. Healy

  James I. Healy, Managing Director

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


 

  PURCHASERS:
  ALLOY PARTNERS 2000, L.P.
  ALLOY VENTURES 2000, L.P.
  ALLOY CORPORATE 2000, L.P.
  ALLOY INVESTORS 2000, L.P.
  ALLOY ANNEX I, L.P.
   

/s/ [Illegible]

  By:   Alloy Ventures 2000, LLC,
    its General Partner
Address:   480 Cowper Street, 2nd Floor
  Palo Alto, CA 94301

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


PURCHASERS:

 

Signed for and on behalf of GBS Venture Partners
Limited
(ABN 54 072 515 247) in its capacity as
trustee of GBS BioVentures II
/s/ Brigitte Smith     /s/ Geoff Brooke
Director     Director
Brigitte Smith     Geoff Brooke
Name     Name
Signed for and on behalf of GBS Venture Partners Limited (ABN 54 072 515 247) in its capacity as trustee of the Genesis Fund
/s/ Brigitte Smith     /s/ Geoff Brooke
Director     Director
Brigitte Smith     Geoff Brooke
Name     Name

 

Address:    Level 5, 71 Collins St.
  

Melbourne Vic, Australia

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


       PURCHASERS:
  Mitsubishi UFJ Capital II, Limited partnership
  by:   Mitsubishi UFJ Capital its General Partner
  By:  

/s/ Yoshihiro Hashimoto

  Name:   Yoshihiro Hashimoto
  Title:   President
Address:       1-7-17 Nihonbashi, Chuo-ku
          Tokyo, 103-0027, Japan

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


  PURCHASERS:
  GENZYME CORPORATION
  By:   /s/ David Meeker
  Name:   David Meeker
  Title:   President and Chief Executive Officer
Address:   Genzyme Corporation
      500 Kendall Street
      Cambridge, MA 02142

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


    PURCHASERS:
  G&H PARTNERS
  By:   /s/ Jonathan Gleason
  Name:   Jonathan Gleason
  Title:    
Address:   c/o Gunderson Dettmer
  1200 Seaport Blvd.
  Redwood City, CA 94063

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


    PURCHASERS:
  BAXTER INTERNATIONAL INC.
  By:   /s/ Michael Baughman
  Name:   Michael Baughman
  Title:   CVP Controller

Address:

 

One Baxter Parkway

 

Deerfield, IL 60015-4625

 

SIGNATURE PAGE TO KALOBIOS PHARMACEUTICALS, INC.

AMENDED AND RESTATED RIGHT OF FIRST REFUSAL AND CO-SALE AGREEMENT


EXHIBIT A

5AM Investors, LLC

5AM Co-Investors, LLC

Singapore Bio-Innovations Pte Ltd.

Sofinnova Venture Partners V, LP

Sofinnova Ventures Affiliates V, LP

Sofinnova Venture Principals V, LP

Alloy Partners 2000, L.P.

Alloy Ventures 2000, L.P.

Alloy Corporate 2000, L.P.

Alloy Investors 2000, L.P.

Alloy Annex I, L.P.

Lotus BioScience Investment Holdings Ltd.

GBS Venture Partners Limited, as trustee of the Bioscience Ventures II Fund and the Genesis Fund

Robert Balint

James Larrick

MPM BioVentures III, L.P.

MPM BioVentures III-QP, L.P.

MPM BioVentures III GmbH & Co. Beteiligungs KG

MPM BioVentures III Parallel Fund, L.P.

MPM Asset Management Investors 2005 BVIII LLC

MPM BioVentures Strategic Fund, L.P.

Howard Baer

Stuart E. Builder

George Sachs

LB I Group Inc.

Mitsubishi UFJ Capital II, Limited partnership

Genzyme Corporation

G&H Partners

Montgomery & Co., LLC

Baxter International Inc.

Development Bank of Japan

Fidelity Advisor Series I: Fidelity Advisor Dividend Growth Fund

Fidelity Advisor Series VII: Fidelity Advisor Biotechnology Fund

Fidelity Magellan Fund: Fidelity Magellan Fund

Fidelity Rutland Square Trust II: Strategic Advisers Core Fund

Fidelity Rutland Square Trust II: Strategic Advisers Core Multi-Manager Fund

Fidelity Securities Fund: Fidelity Dividend Growth Fund

Fidelity Select Portfolios: Biotechnology Portfolio

Variable Insurance Products Fund III: Balanced Portfolio

 

S-2


EXHIBIT B

Capital Stock of the Company Beneficially Owned by the Key Common Holders

 

Key Common Holder

  

Class/Series of Stock

  

Number of Shares

David Pritchard    Common    2,273,521
Geoffrey Yarranton    Common    931,645
Dan Shochat    Common    826,394
5AM Ventures LLC    Common    514,882
5AM Co-Investors LLC    Common    57,413

 

S-2

Exhibit 10.12

DEVELOPMENT, COMMERCIALIZATION

COLLABORATION AND LICENSE AGREEMENT

This D EVELOPMENT , C OMMERCIALIZATION C OLLABORATION AND L ICENSE A GREEMENT (the “ Agreement ”) is entered into on January 8, 2010 (the “ Effective Date ”) between K ALO B IOS P HARMACEUTICALS , I NC . , a Delaware corporation, with its principal place of business at 260 East Grand Avenue, South San Francisco, California, U.S.A. 94080 (“ KaloBios ”), and S ANOFI P ASTEUR S.A. , a company organized and existing under the laws of the Republic of France, having offices located at 2, avenue Pont Pasteur, 69007 Lyon, France (“ Sanofi ”). KaloBios and Sanofi are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

W HEREAS , KaloBios has developed engineered antibodies targeting the PcrV protein of Pseudomonas aeruginosa (“ Pa ”) for the prevention and for the treatment of Pa infections and owns and controls certain intellectual property rights related thereto;

W HEREAS , Sanofi is a pharmaceutical company with experience in the development and commercialization of pharmaceutical products;

W HEREAS , Sanofi desires to obtain exclusive rights to develop, manufacture and commercialize one or more products binding to and inhibiting the activity of PcrV in order to obtain marketing approval of such products for various indications, and KaloBios desires to grant Sanofi such rights, all as set forth below.

W HEREAS , KaloBios and Sanofi wish to collaborate to develop products to treat or prevent Pseudomonas aeruginosa infections and related indications, including ventilator associated pneumonia, cystic fibrosis, and bronchiectasis.

N OW T HEREFORE , in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following initially capitalized terms, whether used in the singular or plural form, shall have the meanings set forth in this Article 1, or if not listed in Article 1, the meanings as designated in the text of this Agreement.

1.1 Affiliate ” means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock of such entity, or by contract or otherwise.

 

Page 1 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.2 Antibody ” means any immunoglobulin or fragment thereof, including Fab, F(ab)’2, Fab’ fragments, or a protein comprising at least one CDR portion derived from said immunoglobulin (including bispecific antibodies, single chain antibodies, domain antibodies and immunoconjugated antibodies); whether human, humanized, Humaneered TM , chimeric, murine, synthetic or from any other source, including chemically modified derivatives thereof. For clarity, [***], KB001 and KB001-A are Antibodies.

1.3 Bronchiectasis ” means a condition characterized by permanent dilation of the bronchi, which can result in recurrent respiratory infections, a disabling cough, shortness of breath, and hemoptysis (coughing up blood). The condition may be triggered by chronic respiratory infections and the associated inflammatory response.

1.4 Bulk Substance ” means any Licensed Product manufactured in accordance with the specifications agreed to by the Parties and cGMP, which has undergone all processing steps except the steps of formulation, filling and packaging.

1.5 Change of Control ” means with respect to any Party (the “ Acquired Entity ”) (a) any sale, exchange, transfer, or issuance to or acquisition by one or more Third Parties of shares representing more than fifty percent (50%) of the aggregate ordinary voting power entitled to vote for the election of directors represented by the issued and outstanding stock of the Acquired Entity or any Affiliate that directly or indirectly controls the Acquired Entity (whether by sale or merger, but excluding the issuance of shares in financing transactions), whether such sale, exchange, transfer, issuance or acquisition is made directly or indirectly, beneficially or of record or in one transaction or a series of related transactions; (b) a merger or consolidation under applicable law of the Acquired Entity with a Third Party in which the shareholders of the Acquired Entity or any Affiliate that directly or indirectly controls the Acquired Entity immediately prior to such merger or consolidation do not continue to hold immediately following the closing of such merger or consolidation at least fifty percent (50%) of the aggregate ordinary voting power entitled to vote for the election of directors represented by the issued and outstanding stock of the entity surviving or resulting from such consolidation; or (c) a sale or other disposition of all or substantially all of the assets of the Acquired Entity to which this Agreement relates to one (1) or more Third Parties in one transaction or a series of related transactions.

1.6 Clinical Lot Manufacturing Cos ts” means the costs incurred by a Party in connection with the manufacture, supply, testing, shipment, release and other activities relating to the procurement of the Licensed Product(s), placebos and comparator drugs used in the Development of the Licensed Products.

1.7 Commercial Costs ” means the internal costs and amounts paid to Third Parties incurred as an expense in accordance with U.S. generally accepted accounting principles by or on behalf of a Party or its Affiliates in carrying out the Commercialization to the extent applicable to the Licensed Product.

 

Page 2 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.8 Commercialization ”, with a correlative meaning for “Commercialize” and “Commercializing-, means all activities undertaken before and after obtaining Regulatory Approvals relating specifically to the pre-launch, launch, promotion, detailing, medical education and medical liaison activities, marketing, pricing, reimbursement, sale, and distribution of a product including: (a) Promotion; (b) any commercialization studies for use in generating data to be submitted to Regulatory Authorities and/or recommending bodies (and all associated reporting requirements) in the Territory, (c) any clinical studies conducted following Regulatory Approval; (d), booking sales and product distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions.

1.9 Commercially Reasonable Efforts ” means, with respect to the efforts to be expended by any Party for any objective or task, those reasonable and good faith efforts to accomplish such objective or task that such Party (taking into account the size, resources and practices of the Party exercising such efforts) normally would devote to a product of similar market or profit potential within its portfolio consistent with the exercise of prudent scientific and business judgment. Commercially Reasonable Efforts requires that a Party, at a minimum, assign responsibility for such obligations to qualified employees, set annual goals and objectives for carrying out such obligations, and allocate resources designed to meet such goals and objectives.

1.10 Confidential Information ” means any and all information communicated in writing, orally or visually or in any tangible or electronic form or media, and any full or partial copies thereof, disclosed by the disclosing Party relating to, but not limited to, business plans and strategy, research and development (including but not limited to pre-clinical studies and current and future clinical trials), relationships with Third Parties, technology, trade secrets, Know-How, proprietary information, inventions (whether or not patentable), Patent applications, licenses, software, programs, prototypes, designs, analysis codes, discoveries, techniques, methods, ideas, concepts, data, engineering and manufacturing information, procedures, specifications, diagrams, drawings, schematics, blue prints, parts lists, and samples, and financial information, and also the confidential information of any Third Party which is disclosed to the disclosing Party and is in turn disclosed to the receiving Party or otherwise learned by through visual or other inspection. Any Development Plan and Commercialization plan developed by a Party under this Agreement shall also be deemed Confidential Information of the applicable Party. The Parties agree that all information identified as confidential at the time of disclosure, whether visually, in writing, verbally or any tangible or electronic form or media, shall be deemed Confidential Information. All Confidential Information disclosed by Sanofi pursuant to the Confidentiality Agreement between the Parties dated August 1, 2009 and also that disclosed by KaloBios pursuant to the Confidentiality Agreement dated March 30, 2009 shall be deemed to be such Party’s respective Confidential Information disclosed hereunder.

1.11 Control ” means, with respect to any material, Know-How, or intellectual property right, that a Party (a) owns or (b) has a license to, and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other arrangement with any Third Party.

 

Page 3 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.12 Cystic Fibrosis ” (also known as CF or mucoviscidosis) means a hereditary disease caused by a mutation in a gene called the cystic fibrosis transmembrane conductance regulator (CFTR), which governs the production of certain bodily secretions (sweat, digestive juices, mucus). The condition is characterized by lung disease, which results from clogging of the airways due to mucosa build-up and leads to recurring cycles of infection and inflammation and difficulty in breathing, which often results in progressive lung failure and death in relatively young individuals.

1.13 Develop ” or “ Development ” means all activities including process and formulation development activities relating to preparing and conducting preclinical research and testing, toxicology testing, human clinical studies, and regulatory activities (e.g., regulatory applications) in furtherance of seeking and obtaining Regulatory Approval for a pharmaceutical product, together with the manufacturing of such for the purpose of conducting the foregoing activities.

1.14 Development Costs ” means the internal costs and amounts paid to Third Parties incurred as an expense in accordance with generally acceptable accounting standards of France or US GAAP, consistently applied by or on behalf of a Party or its Affiliates in carrying out the Development of the Licensed Product in accordance with the approved Development Plan, including (a) the costs of Phase 1, Phase 2 and Phase 3 Clinical Trials (including costs of procuring the Licensed Product(s), placebos and comparator drugs used in such clinical trials), (b) filing fees and other costs associated with any Regulatory Filings; and (c) all other costs that are directly attributable and reasonably allocable to the Development activities for the Licensed Products.

1.15 Development Plan ” means the KaloBios Development Plan or the Sanofi Development Plan, as applicable.

1.16 Dollar ” means a U.S. dollar, and “ $ ” shall be interpreted accordingly

1.17 Drug Approval Application ” or “ DAA ” means a Biologics License Application or a New Drug Application, as defined in the United States Public Health Service Act or the FD&C Act, as amended, and the regulations promulgated thereunder, or any corresponding application with respect to a country or territory other than the United States, including, with respect to the European Union, a marketing authorization application filed with the EMEA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in the European Union with respect to the mutual recognition or any other national approval procedure.

1.18 EMEA ” means the European Medicines Agency or any successor agency thereto.

1.19 Excluded Company ” means any of the top twenty-five pharmaceutical companies by market capitalization, as determined at the applicable time during the Term.

1.20 Ex-US Countries ” means the rest of the world that does not comprise the U.S. Territory.

 

Page 4 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.21 [***] ” means the Humaneered TM Antibody Fab’ fragment with the amino acid sequence as set out in Exhibit A .

1.22 [***] ” means the Humaneered TM Antibody Fab’ fragment with the amino acid sequences as set out in Exhibit B .

1.23 [***] ” means the Humaneered TM Antibody Fab’ fragment with the amino acid sequence as set out in Exhibit C .

1.24 FD&C Act ” means the U.S. Federal Food, Drug and Cosmetic Act, as amended.

1.25 FDA ” means the U.S. Food and Drug Administration or any successor agency thereto.

1.26 First Commercial Sale ” means the first sale to a Third Party of a Licensed Product by a Party or its sublicensee in a given regulatory jurisdiction after Regulatory Approval has been obtained in such jurisdiction.

1.27 Field ” means the diagnosis, treatment and/or prophylaxis of all human diseases and conditions caused by Pseudomonas aeruginosa or otherwise associated with Pseudomonas aeruginosa infections.

1.28 FTE ” means the equivalent of a full-time individual’s work for a twelve (12) month period directly related to activities under this Agreement. FTE efforts shall not include general corporate, administrative or executive overhead.

1.29 FIE Rate ” means the partially burdened FTE personnel cost incurred by a Party, which shall initially be at an annual rate of [***] per FTE. The FTE Rate shall be subject to adjustment each calendar year during the Term based upon a Party’s reasonable and documented increases to its FTE costs, provided that any such annual increase shall not exceed [***].

1.30 Good Clinical Practice ” or “ GCP ” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures in jurisdictions outside the U.S., as they may be updated from time to time, including applicable quality guidelines promulgated under the International Conference on Harmonization (“ ICH ”).

1.31 Good Laboratory Practice ” or “ GLP ” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside the U.S., as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

1.32 Good Manufacturing Practice ,” “ cGMP ” or “ GMP ” means the then-current good manufacturing practices required by the FDA, as set forth in the FD&C Act and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions in the Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

 

Page 5 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


CONFIDENTIAL TREATMENT REQUESTED

 

1.33 Governmental Authority ” means any multi-national, federal, state, local, municipal, provincial or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.34 Humaneering TM ” and “ Humaneeredrm ” refer to KaloBios’ proprietary technology (including any Patent or Know-How related thereto) to transfer minimal binding specificity regions from selected antigen specific antibodies to a human V-segment to form an Antibody that has a greater than a ninety percent (90%) degree of amino acid sequence identity to human antibodies.

1.35 IND ” means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated hereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction outside the U.S., the filing of which is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

1.36 Indication ” means each separate and distinct human disease, disorder or condition.

1.37 Joint Inventions ” has the meaning set forth in Section 9.1.

1.38 Joint Patent ” has the meaning set forth in Section 9.1.

1.39 Joint Steering Committee ” or “ JSC ” means the committee formed by the Parties as described in Section 3.1.

1.40 KaloBios Commercialization Plan ” has the meaning set forth in Section 6.3(b).

1.41 KaloBios Development Costs ” has the meaning set forth in Section 4.8(b)(i).

1.42 KaloBios Development Plan ” has the meaning set forth in Section 4.2(b).

1.43 KaloBios Field ” means the diagnosis, treatment and/or prophylaxis of Pseudomonas aeruginosa in patients with either Cystic Fibrosis or Bronchiectasis.

1.44 [***].

1.45 KaloBios Platform ” means KaloBios’ proprietary technology covering Fab’ expression, purification or site specific PEGylation, Humaneering TM , and signal-less expression technologies, in each case as and to the extent described in any Patent or Know-How owned by KaloBios and disclosed to Sanofi during the Term.

 

Page 6 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.46 KaloBios Know-How ” means all Know-How that is Controlled by KaloBios or its Affiliates as of the Effective Date or during the Term and which is necessary for the Development, manufacture and/or Commercialization of a Licensed Product. [***].

1.47 KaloBios Patent ” means any Patent that (a) is Controlled by KaloBios or its Affiliates as of the Effective Date or at any time during the Term (including KaloBios’ interest in any Joint Patents), and (b) claims the composition of matter, manufacture or use of a Licensed Product, which but for the licenses granted to Sanofi herein would be infringed by the manufacture, use or sale of such Licensed Product. KaloBios Patents existing as of the Effective Date are set forth on Exhibit D attached hereto. [***].

1.48 KaloBios Sublicense Agreement ” has the meaning ascribed to it in Section 2.2(c).

1.49 KaloBios Technology ” means the KaloBios Patents and KaloBios Know-How.

1.50 KB001 ” means [***].

1.51 KB001-A ” means the [***].

1.52 Know-How ” means any data, results, technology, business information and information of any type whatsoever, in any tangible or intangible form, including, any confidential and proprietary know-how or trade secret, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, Materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical, toxicological, preclinical and clinical test data), analytical and quality control data, stability data, other study data and procedures.

1.53 Laws ” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

1.54 Licensed Product ” means any Antibody that (a) has been raised, engineered or otherwise targeted or optimized to bind specifically and directly to PcrV (whether exclusively or in addition to any other target such Antibody may modulate) and (b) competes for binding to PcrV with a naturally occurring receptor of PcrV, or, once bound to the PcrV, exhibits antagonistic activity against PcrV, agonist activity against PcrV, ADCC (antibody dependent cellular cytotoxity) and/or other Fe-mediated effector function, including [***], KB001, KB001-A or another anti- Pa Antibody targeting PcrV that is Developed under this Agreement or through the exercise of any license right granted to KaloBios and/or Sanofi under this Agreement. For clarity, the following shall, for the purposes of Section 8.3(c) (i.e. Royalty Term) be considered the same Licensed Product: [***].

1.55 [***] ” means the mouse Antibody with the amino acid sequence as set out in Exhibits E-1 and E-2 .

 

Page 7 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


CONFIDENTIAL TREATMENT REQUESTED

 

1.56 Marks ” means trade marks, service marks, trade names, service names, logos, slogans, tag lines, trade dress, and internet domain names and addresses.

1.57 Materials ” has the meaning ascribed to it in Section 2.6.

1.58 Net Sales ” means the gross amount invoiced by Sanofi, its Affiliates, its permitted agents or its permitted sub-licensees on account of sales of Licensed Product to Third Parties (including without limitation Third Party distributors and wholesalers), less the total of each of the following, in each case to the extent actually incurred or allowed and not already deducted, credited or otherwise reflected in the amount invoiced:

(a) trade, cash and/or quantity discounts, credits, allowances, rebates and returns (including, but not limited to, wholesaler and retailer returns);

(b) excise, sales and other consumption taxes and customs duties and other compulsory payments made to government authorities to the extent included in the invoice price;

(c) amounts repaid or credited by reason of rejections, defects, recalls or returns or because of charge-backs, retroactive price reductions, refunds or billing errors; and

(d) sales commissions actually paid to any Third Party and non-employee wholesalers and distributors.

Each of the deductions set forth above shall be reasonable and customary, and shall be determined on an accrual basis in accordance with applicable generally acceptable accounting standards of France or US GAAP, consistently applied and as applicable to the booking of such sales for a particular territory.

A sale of a Licensed Product is deemed to occur upon invoicing. If any discounts or other deductions are made in connection with sales of the Licensed Product that are sold together with other products of Sanofi, its Affiliates or its/their sublicensee (in one or a series of related transactions), in no event will the discount applied to the Licensed Product exceed the discount applied to other products of Sanofi, its Affiliates or its/their sublicensees in such arrangement based upon the respective list prices of the Licensed Product and such other products prior to applying the discount. Net Sales shall not include reasonable transfers or dispositions, at no cost, as samples or for charitable purposes, or transfers or dispositions at no cost for preclinical, clinical or regulatory purposes.

1.59 Non-FTE Development Costs ” means all out-of-pocket Third Party costs and expenses incurred by or on behalf of a Party in performing its obligations under then-current Development Plan that are directly attributable and reasonably allocated to the Development Plan. For clarity, Non-FTE Development Costs shall exclude (a) all personnel, equipment, reagents and all expenses associated with a FTE and (b) all costs included in the FTE Rate.

1.60 Option ” has the meaning set forth in Section 4.9(a).

1.61 Pa ” means Pseudomonas aeruginosa .

 

Page 8 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.62 Patent ” or “ Patents ” means (a) pending patent applications (and patents issuing therefrom), issued patents, utility models and designs; and (b) reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any patents, patent applications, utility models or designs.

1.63 PcrV ” means the Pseudomonas homolog of Yersinia low-calcium response V antigen, a specific protein antigen that is an integral component of the Type Three Secretion System (TTSS) of the bacterium Pseudomonas aeruginosa .

1.64 Phase 1 Clinical Trial ” means a clinical trial of a Licensed Product in healthy subjects or patients with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of such Licensed Product.

1.65 Phase 2 Clinical Trial ” means a clinical trial of a Licensed Product in patients, including pharmacokinetic studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials.

1.66 Phase 2b Clinical Trial ” shall mean any Phase 2 Clinical Trial of a Licensed Product that is intended to enable a Phase 3 Clinical Trial and is conducted to provide a preliminary determination of safety and efficacy of such Licensed Product in the target patient population over a range of doses and dose regimens.

1.67 Phase 3 Clinical Trial ” means a clinical trial of a Licensed Product in sufficient numbers of patients, which trial(s) are designed to (a) establish that such Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed; and (c) support approval of an application to a Regulatory Authority for the commercial marketing of such Licensed Product.

1.68 Promote ” or “ Promotion ” means, with respect to a product the following: (a) strategic marketing, advertising, medical education and liaison, national account managers, and market support; (b) development and use of product labeling and promotional materials; (c) detailing a product involving the communication by a sales representative during a sales call that describes the indicated uses and other relevant characteristics of such product and using promotional materials in an effort to increase the prescribing and/or hospital ordering preferences of such product for its indicated uses (whether or not such communications are made at a medical professional’s office, in a hospital or at marketing meetings); and (d) branding and Marks generation.

1.69 Regulatory Approval ” means, with respect to a product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant Regulatory Authority in a country or jurisdiction that is specific to such product and necessary to market and sell such product in such country or jurisdiction.

 

Page 9 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.70 Regulatory Authority ” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent required in such country or regulatory jurisdiction, pricing or reimbursement approval of a Licensed Product in such country or regulatory jurisdiction, including (a) the FDA, and (b) the EMEA, and in each case, including any successor thereto.

1.71 Regulatory Exclusivity ” means any period of data, market or other regulatory exclusivity (including supplementary protection certificates), including any such periods under national implementations in the European Union of Section 10.1(a)(iii) of Directive 2001/EC/83, as amended from time to time, and all international equivalents.

1.72 Regulatory Filings ” means, with respect to the Licensed Products, any submission to a Regulatory Authority of any appropriate regulatory application specific to Licensed Products, and shall include any submission to a regulatory advisory board and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any IND, DAA or the corresponding application in any other country or group of countries.

1.73 Sanofi Commercialization Plan ” has the meaning set forth in Section 6.2(d).

1.74 Sanofi Development Plan ” has the meaning set forth in Section 4.2(a).

1.75 Sanofi Field ” means the Field, but excluding the KaloBios Field.

1.76 Sanofi Know-How ” means all Know-How that is Controlled by Sanofi or its Affiliates as of the Effective Date or during the Term and is necessary for the Development, manufacture and/or Commercialization of a Licensed Product. [***].

1.77 Sanofi Option Period ” means that period beginning on the Effective Date and ending the earlier of (a) the date on which Sanofi exercises either of its options as set out in Section 4.9 and (b) ninety days following the delivery by KaloBios of the final clinical study report from the KaloBios Phase 2b Trial.

1.78 Sanofi Patent ” means any Patent that (a) is Controlled by Sanofi or its Affiliates as of the Effective Date or at any time during the Term (including Sanofi’s interest in any Joint Patents), and (b) claims the composition of matter, manufacture or use of a Licensed Product. [***].

1.79 Sanofi Sublicense Agreement ” has the meaning ascribed to it in Section 2.1(c).

1.80 Sanofi Technology ” means the Sanofi Patents and Sanofi Know-How, and for greater certainty includes the rights licensed from KaloBios hereunder during the Term.

1.81 Sole Inventions ” has the meaning set forth in Section 9.1.

1.82 Term ” means the term of this Agreement, as set forth in Section 13.1.

1.83 Territory ” means the entire world.

 

Page 10 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.84 Third Party ” means any person or entity other than KaloBios or Sanofi or an Affiliate of either of them.

1.85 Third Party License ” shall mean (a) any of the agreements set forth in Exhibit F and (b) any license agreement that is entered into by a Party with a Third Party after the Effective Date in accordance with Section 8.5.

1.86 U.S. Territory ” means the United States and its territories and possessions.

1.87 Valid Claim ” means, on a country-by-country basis, a claim of an issued and unexpired (as may be extended through a patent term extension) KaloBios Patent or a claim of an issued and unexpired Joint Patent, wherein such claim has not been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or a judgment from which no appeal was taken within the allowable time period) and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise. For further clarification, any periods of Regulatory Exclusivity or data package exclusivity shall not be construed as affecting the duration of a “Valid Claim.”

ARTICLE 2

LICENSES AND EXCLUSIVITY

2.1 License to Sanofi under KaloBios Technology .

(a) License . Subject to the terms and conditions of this Agreement, KaloBios hereby grants Sanofi and its Affiliates an exclusive (even as to KaloBios except as provided in Section 2.1(b) below), royalty-bearing license, with the right to grant sublicenses to Third Parties through one or more tier(s) (subject to Section 2.1(c) below), under the KaloBios Technology, to Develop, make, have made, use, sell, offer for sale, have sold, import, export and otherwise Commercialize Licensed Products in the Field in the Territory. For purposes of this Agreement, all references to “sublicensees” and provisions applicable to such sublicensees (other than Section 2.1(c)) shall include and apply to Sanofi Affiliates, provided that Sanofi shall not be obligated to enter into Sanofi Sublicense Agreements pursuant to subsection (c) below with any of its Affiliates.

(b) KaloBios Retained Rights . Notwithstanding the rights granted to Sanofi in Section 2.1(a), KaloBios and its Affiliates retains the right to conduct those activities that it is responsible for under the Sanofi Development Plan under this Agreement.

(c) Sublicenses . Sanofi shall, within [***] after granting any sublicense under Section 2.1(a) above, notify KaloBios of the grant of such sublicense and provide KaloBios with an appropriately redacted copy of such sublicense agreement (each, a “ Sanofi Sublicense Agreement ”). Each Sanofi Sublicense Agreement shall be consistent with and subject to the terms and conditions of this Agreement and any applicable Third Party Licenses. Each Sanofi Sublicense Agreement shall provide the following to KaloBios if this Agreement terminates, and to Sanofi if only such Sanofi Sublicense Agreement terminates: (i) the assignment and transfer of ownership and possession of all Regulatory Filings and Regulatory

 

Page 11 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


Approvals held or possessed by such sublicensee (which assignment could also be directly to Sanofi prior to any such termination), and (ii) the assignment of, or a freely sublicenseable exclusive license to, all intellectual property Controlled by such sublicensee that covers or embodies a Licensed Product or its respective use, manufacture, sale, or importation and was created by or on behalf of such sublicensee during the exercise of its rights or fulfillment of its obligations pursuant to such Sanofi Sublicense Agreement.

2.2 Licenses to KaloBios under Sanofi Technology .

(a) Licenses . Subject to the terms and conditions of this Agreement, Sanofi hereby grants KaloBios and its Affiliates:

(i) an exclusive (even as to Sanofi except as provided in Section 2.2(b) below), [***] license, with the right to grant sublicenses through one or more tiers (subject to Section 2.2(c) below for the grant of each sublicense), under the Sanofi Technology, to Develop, manufacture and have manufactured Licensed Products (which shall be limited to Licensed Products other than Bulk Substance for so long as Sanofi is manufacturing Bulk Substance as described in Article 7) and Promote Licensed Products in the KaloBios Field in the Territory.

(ii) a non-exclusive, fully-paid license in the Territory under the Sanofi Technology to perform KaloBios’ obligations under this Agreement.

(b) Sanofi Retained Rights . Notwithstanding the rights granted to KaloBios in Section 2.2(a), Sanofi retains the rights to conduct those activities it is responsible for under the KaloBios Development Plan under this Agreement.

(c) Sublicenses . During the Sanofi Option Period, KaloBios shall not have the right to grant sublicenses under Sections 2.2(a)(i) without the prior written consent of Sanofi. Thereafter, KaloBios shall have the right to grant sublicenses to any Third Party (other than an [***]) for any territory other than the U.S. Territory, subject to this Section 2.2(c). KaloBios shall, within thirty (30) days after granting any sublicense under Section 2.2(a)(i) above, notify Sanofi of the grant of such sublicense and provide Sanofi with an appropriately redacted copy of such sublicense agreement (each, a “ KaloBios Sublicense Agreement ”). Each KaloBios Sublicense Agreement shall be consistent with and subject to the terms and conditions of this Agreement and any applicable Third Party Licenses. KaloBios shall, in each agreement under which it grants a sublicense under the license set forth in Section 2.2(a)(i) (each, a “ KaloBios Sublicense Agreement ”), require the sublicensee (i) to provide all Confidential Information to KaloBios so that KaloBios and Sanofi may comply with their obligations hereunder, and (ii) to provide the following to KaloBios if such KaloBios Sublicense Agreement terminates: (A) the assignment and transfer of ownership and possession of all Regulatory Filings and Regulatory Approvals held or possessed by such sublicensee, and (B) the assignment of, or a freely sublicenseable exclusive license to, all intellectual property Controlled by such sublicensee that covers or embodies a Licensed Product or its respective use, manufacture, sale, or importation and was created by or on behalf of such sublicensee during the exercise of its rights or fulfillment of its obligations pursuant to such KaloBios Sublicense Agreement. Upon any sublicense by KaloBios under this Section 2.2(c), the Parties shall jointly agree as necessary to mutual and reasonable restrictions on the exchange of Confidential Information between Sanofi and such KaloBios sublicensee except as to the extent necessary for the Parties to reasonably comply with their obligations under this Agreement.

 

Page 12 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


2.3 Negative Covenant . Sanofi covenants that it will not, and it will not permit any of its Affiliates to, use or practice any KaloBios Technology licensed hereunder outside the scope of the license granted to it under Section 2.1. KaloBios covenants that it will not, and it will not permit any of its Affiliates to, use or practice any Sanofi Technology licensed to it outside the scope of the license granted to it under Section 2.2.

2.4 No Implied Licenses . Except as set forth herein, neither Party acquires any license or other intellectual property interest, by implication or otherwise, under any trademarks, Patents or Patent applications owned or Controlled by the other Party.

2.5 Third Party Licenses . The licenses granted to Sanofi and to KaloBios in Section 2 include sublicenses under KaloBios Technology licensed to KaloBios pursuant to those Third Party Licenses set forth on Exhibit F which have been disclosed to Sanofi as of the Effective Date. Such sublicenses are subject to the limitations set forth in such Third Party Licenses (including without limitation any limitations on the scope and exclusivity of the licenses granted to KaloBios thereunder and any constraints on KaloBios’ ability to prosecute or enforce KaloBios Patents licensed pursuant to such Third Party Licenses).

2.6 Material Transfer . From time to time, either Party may transfer to the other Party tangible biological or other materials, including but not limited to cells and any expression product, progeny, derivatives thereto (collectively, “ Materials ”). Each Party agrees to use any Materials solely in connection with activities it is authorized to perform under this Agreement and for no other purpose. Without limiting the generality of the foregoing, except as expressly set forth in this Agreement, neither Party shall make or attempt to make analogs, progeny or derivatives of, or modifications to, the Materials provided by the other Party, except with such providing Party’s prior written consent. Each Party shall comply with all applicable Laws, rules and regulations regarding the handling and use of the Materials and to retain possession over the Materials, except for Materials transferred to Third Parties as permitted herein. In the event that a Party (or any Third Party transferee) uses the Materials for any purpose not authorized hereunder, the results of such unauthorized research, and any discoveries or inventions that arise from such unauthorized research, whether patentable or not, shall belong solely and exclusively to the providing Party, and the other Party hereby assigns and agrees to assign to the providing Party all of its right, title and interest in and to all such results, discoveries or inventions. All right, title and interest in Materials provided shall remain the property of the Party providing such Materials.

2.7 Exclusivity .

(a) [***].

(b) [***].

(c) [***].

(d) [***].

 

Page 13 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(e) JSC . In the event of the Change of Control of KaloBios and such KB Acquiror Controls a KaloBios Competitive Product, the JSC and JPT will be discontinued and Sanofi will thereafter inform KaloBios once a year of the advancement of the Development of the Licensed Product(s).

ARTICLE 3

OVERVIEW; MANAGEMENT

3.1 Overall Management Structure . The overall management of the collaboration shall be vested in the Joint Steering Committee (the “ JSC ”), which will monitor and oversee the Parties’ activities under this Agreement and facilitate communications between the Parties with respect to the Development and Commercialization of the Licensed Products. The JSC may establish one (1) or more other committees that report to the JSC and assist the JSC in managing and directing the collaboration. Any committees formed beyond the JSC shall be subordinate to the JSC, shall have such membership and responsibilities as the JSC may determine, and may be disbanded by the JSC at any time.

3.2 Joint Steering Committee .

(a) Formation and Role . Within thirty (30) days after the Effective Date or such further period of time as the Parties may agree, the Parties shall establish the JSC. The role of the JSC shall be:

(i) to discuss and coordinate regarding the overall strategy for conducting Development of and seeking Regulatory Approval for and Commercializing Licensed Products in the Territory by each Party in its respective field;

(ii) to review, discuss and approve any proposed amendments or revisions to the Sanofi Development Plan and KaloBios Development Plan;

(iii) to establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement and monitor the activities and performance of such subcommittees;

(iv) to coordinate the Parties’ efforts with respect to the manufacture of Licensed Product in accordance with Article 7 for the KaloBios Field and the Sanofi Field;

(v) to review and approve publication plans; and

(vi) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties in writing (subject to Section 3.2(e)).

(b) JSC Membership . KaloBios and Sanofi shall each designate an equal number of representatives (each of whom shall be a senior executive of the applicable Party) to serve on the JSC by written notices to the other Party, initially, each Party shall designate four (4) senior level representatives. The JSC may elect to vary the number of representatives from time to time during the Term. Either Party may designate substitutes for its representatives if

 

Page 14 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


one (1) or more of such Party’s designated representatives is unable to be present at a meeting. From time to time each Party may replace its representatives by written notice to the other Party specifying the prior representative(s) and their replacement(s). The Chairperson of the JSC shall be appointed by Sanofi and shall be responsible for (i) calling meetings, (ii) preparing and issuing minutes of each such meeting within thirty (30) days thereafter, and (iii) preparing and circulating an agenda for the upcoming meeting, but shall have no special authority over the other members of the JSC, and shall have no additional voting rights or powers beyond those held by the other JSC members.

(c) JSC Decisions and Actions . The JSC shall make decisions and act as follows:

(i) Sanofi shall have the final decision making authority on any matter relating to the Sanofi Development Plan or the Development or Commercialization of Licensed Products in the Sanofi Field, provided that any final determination shall be consistent with the terms of this Agreement, and not materially affect the rights and obligations of KaloBios, require KaloBios to perform any Development or other activity under this Agreement or modify KaloBios’ obligations under the then-current Sanofi Development Plan. In addition, Sanofi shall not make any decision with respect to the following critical issues without the consent of KaloBios, such consent not to be unreasonably withheld: (A) materially delay or cease to seek Regulatory Approval for any Licensed Product; or (B) delay or cancel the commercial launch any Licensed Product; and

(ii) During the Sanofi Option Period, KaloBios shall have the final decision making authority on any matter relating to the KaloBios Development Plan or the Development or Commercialization of Licensed Products in the KaloBios Field, other than (A) the overall design of the KaloBios Phase 2b Trial (which decision shall be made jointly by the Parties and any dispute shall first be submitted to the expert as provided in subsection (g) of this Section 3.2 and, failing resolution through such process, then the Parties may avail themselves of the process described in Section 14.2 (and not Section 14.3)); or (B) any matter regarding the safety of a Licensed Product or that would materially and potentially adversely impact the regulatory status of Licensed Products in the Sanofi Field; or (C) any evaluation of any safety event; provided that any final determination shall be consistent with the terms of this Agreement, and not materially affect the rights and obligations of Sanofi, or require Sanofi to perform any Development or other activity under this Agreement. In addition, KaloBios shall not make any decision with respect to the following critical issues without the consent of Sanofi, such consent not to be unreasonably withheld: (1) materially delay or cease to seek Regulatory Approval for any Licensed Product; or (2) delay or cancel the commercial launch for any Licensed Product. If Sanofi decides not to exercise its Option during the Sanofi Option Period, KaloBios shall have the final decision making authority on any matter relating to the KaloBios Development Plan or the Development or Commercialization of Licensed Products in the KaloBios Field, other than any matter regarding the safety of a Licensed Product or that would materially and potentially adversely impact the regulatory status of Licensed Products in the Sanofi Field; provided that any final determination shall be consistent with the terms of this Agreement, and not materially affect the rights and obligations of Sanofi, or require Sanofi to perform any Development or other activity under this Agreement. In addition, KaloBios shall not make any decision with respect to the following critical issues without the consent of Sanofi, such consent not to be unreasonably withheld: (1) materially delay or cease to seek Regulatory Approval for any Licensed Product; or (2) delay or cancel the commercial launch for any Licensed Product.

 

Page 15 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(iii) If Sanofi decides to exercise its Option during the Sanofi Option Period, the final decision making authority on any matter relating to the KaloBios Development Plan shall be determined in accordance with Sections 4.9(b)(ii) or 4.9(c)(ii).

(d) Meetings . The JSC shall meet at least quarterly for the first two years following the Effective Date and every six months thereafter unless the Parties mutually agree in writing to a different frequency for such meetings, with at least one in-person meeting during each calendar year. No later than ten (10) business days prior to any regularly scheduled meeting of the JSC, the Chairperson of the JSC shall prepare and circulate an agenda for such meeting and, as soon as practicable, materials for the meeting; provided, however, that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JSC may meet in person, by videoconference or by teleconference. With the prior consent of the other Party’s representatives (such consent not to be unreasonably withheld or delayed), each Party may invite non-members to participate in the discussions and meetings of a Committee, provided that such participants shall not affect either Party’s voting rights or powers and any such individuals shall be subject to the confidentiality provisions set forth in Article 12. Each Party will be responsible for the expense of its respective JSC members’ and guest’s participation in JSC meetings. Meetings of the JSC shall be effective only if at least one (1) representative of each Party is present in such meeting. The chairperson of the JSC will be responsible for preparing reasonably detailed written minutes of all JSC meetings that include material decisions made at such meetings. The JSC chairperson shall send draft meeting minutes to each member of the JSC for review and approval within twenty (20) business days after each JSC meeting. Such minutes will be deemed approved unless one or more members of the JSC objects to the accuracy of such minutes within twenty (20) business days of receipt.

(e) Authority . The JSC shall have only the powers assigned expressly to it in this Article 3 and elsewhere in this Agreement, and shall not have any power to amend, modify or waive compliance with the terms of this Agreement, in particular, the JSC shall have no authority to alter any financial terms of this Agreement, including but not limited to amending, modifying or waiving any funding obligations under any of the Sanofi Development Plan, the KaloBios Development Plan or otherwise under this Agreement.

(f) Discontinuation of Participation in the JSC . It is the Parties’ intention to maintain the JSC and JPTs for as long as is necessary to carry out each Party’s respective Development and Commercialization obligations hereunder. Notwithstanding the foregoing, at any time during the Term and for any reason, either Party shall have the right to withdraw from participation in the JSC upon written notice to the other Party, which notice shall be effective immediately upon receipt (“ Withdrawal Notice ”). Following the issuance of a Withdrawal Notice and subject to this Section 3.2(f), such Party’s representatives to the JSC shall not participate in any meetings of the JSC, nor shall such Party have any right to vote on decisions within the authority of the JSC. If, at any time following the issuance of a Withdrawal Notice, such Party wishes to resume participating in the JSC, such Party shall notify the other Party in writing and, thereafter, such Party’s representatives to the JSC shall be entitled to attend any

 

Page 16 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


subsequent meeting of the JSC and to participate in the activities of, and decision-making by, the JSC as provided in this Article 3 as if a Withdrawal Notice had not been issued by such Party pursuant to this Section 3.2(f). For clarity, the withdrawal by a Party under this Section 3.2(f) shall only limit such Party’s obligations under this Article 3 with respect to participation in the JSC. Upon any discontinuance of the JSC, the JPTs established under Section 3.3 also shall terminate.

(g) Dispute Resolution . In the event of a dispute between the Parties regarding any matter which the Parties are required pursuant to the terms hereof to decide unanimously, either Party may deliver written notice of the subject matter of the dispute to the other Party’s JSC members. The Parties shall amicably attempt to resolve the matter between themselves, but in the event that the Parties have not reached a resolution within ninety (90) days of the receipt of the notice of dispute, the Parties shall jointly engage an independent expert to assist them. The costs of such expert shall be borne equally by the Parties. If the Parties cannot resolve their dispute through an independent expert, either Party may initiate the processes described in accordance with Article 14 hereof.

3.3 Joint Teams .

(a) Establishment of Joint Project Teams . The Parties will establish the following as soon as practicable:

(i) a joint project team to oversee the Development of Licensed Products in the Sanofi Field (the “ SJPT ”);

(ii) a joint project team to oversee the Development of Licensed Products in the KaloBios Field (the “ KJPT ”);

(b) The role of the SJPT and KJPT (collectively the “ JPTs ” or individually a “ JPT ”) is to oversee the Development of Licensed Products under this Agreement. Each JPT will consist of representatives of each Party designated by such Party. Each Party will designate one of its JPT members as the project team leader (each a “ JPT Leader ”) who will be the primary contact person for the other Party for all operational matters relating to the Development of a Licensed Product by such Party. From time to time, on written notice to the other Party, KaloBios and Sanofi each may substitute any of its representatives on the JPT. Upon completion of all joint Development activities or the withdrawal by either Party from the JSC, the JPT will automatically be disbanded.

(c) Tasks of the JPT . Each JPT will: (i) oversee the day-to-day activities of the Parties in the performance of the Sanofi Development Plan and KaloBios Development Plan, respectively; (ii) develop and propose updates to the Sanofi Development Plan and KaloBios Development Plan for review and approval by the JSC in accordance with Section 3.2(a)(ii), including the clinical development plans and clinical trial protocols; (iii) provide a written report to the JSC summarizing the Parties’ progress with respect to the development of Licensed Products under this Agreement in a frequency to be mutually agreed by the Parties in good faith; and (d) take such other actions as are expressly delegated to each JPT by the JSC or by the terms of this Agreement. No JPT will have any power to amend this Agreement or to make decisions assigned to the JSC, and will have only such powers as are specifically delegated to it by the JSC or the terms of this Agreement.

 

Page 17 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(d) JPT Meetings . Each JPT will meet as often as required (and the two JPTs may, where practicable, meet together) for the expeditious execution of the Sanofi Development Plan and the KaloBios Development Plan, but not less than once every calendar quarter prior to the next JSC meeting. Meetings may be held in person or by means of telecommunication (telephone, video, or web conferences); provided, however, that at least one meeting per year will be held in person. The JPT Leaders will be responsible for establishing the meeting schedule, and will alternate in organizing the meetings of the JPT. The JPT Leader organizing a JPT meeting will be responsible for distributing the agenda of the meeting. The organizing JPT Leader will include on the agenda any item within the scope of the responsibility of the JPT that is requested to be included by any member of the JPT, and will distribute the agenda to the JPT no less than one (1) week before the meeting. Each Party may, in its discretion, invite non-voting employees, consultants or advisors (which consultants and advisors will be under an obligation of confidentiality no less stringent than the terms set forth in Article 12) to attend any meeting of the JPT. Each Party will be responsible for the expense of its respective JPT members’ and guest’s participation in JPT meetings.

(e) Meeting Minutes . The JPT Leader who organized the JPT meeting (or their designee) will prepare the meeting minutes within seven (7) business days after each meeting, and will send it to all members of the JPT for review and approval. Minutes will be deemed approved unless any member of the JPT objects to the accuracy of such minutes by providing written notice to the other members of the JPT within fourteen (14) business days of receipt of the minutes. In the event of any such objection that is not resolved by mutual agreement of the JPT Leaders, such minutes will be amended to reflect such unresolved objection.

(f) Decision Making . Decision making at the JPT level shall follow that of the JSC. If the JPT is unable to reach unanimous consent on a particular matter, such matter will be submitted to the JSC for resolution in accordance with Section 3.2(c).

(g) Joint Commercial Operations Team . The Parties may establish a joint commercial operations team (“ JCOT ”) whose role shall be the coordination and execution of the Commercialization of Licensed Products in the KaloBios Field. All aspects of the governance of the JCOT shall be the same as set out above for the JPTs, except that the Parties may opt to have personnel with expertise in Commercialization serve on either or both JPT in lieu of convening the JCOT.

(h) Dispute Resolution . In the event of a dispute between the Parties regarding any matter within the jurisdiction of the JPTs or JCOT, the Parties shall amicably attempt to resolve the matter between themselves, but in the event that the Parties have not reached a resolution within sixty (60) days of the date on which the dispute arose, the JPTs or JCOT shall refer the matter to the JSC.

 

Page 18 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 4

PRODUCT DEVELOPMENT

4.1 Overview of Product Development . The Parties desire and intend to collaborate with respect to the Development of Licensed Products in the Sanofi Field and in the KaloBios Field in the Territory, under the direction of the JSC, as and to the extent set forth in this Agreement. In general, Sanofi shall be responsible, at its sole cost and expense, for the Development and Regulatory Approval of Licensed Products in the Sanofi Field in the Territory. During the Sanofi Option Period, KaloBios shall be responsible, at its cost and expense, for the Development and Regulatory Approval of Licensed Products in the KaloBios Field in the Territory. KaloBios will use Commercially Reasonable Efforts to Develop the Licensed Product for [***] in the KaloBios Field for the treatment of Cystic Fibrosis, or otherwise as the Parties may agree (not to be unreasonably withheld), as and to the extent provided in this Agreement. In addition, KaloBios shall be responsible for certain Development activities for the Licensed Products, at Sanofi’s cost and expense, as specifically described in the Sanofi Development Plan (as defined below) for the Sanofi Field, and as the Parties may otherwise reasonably agree in writing during the Term pursuant to any amendment thereto.

4.2 Development Plans .

(a) Sanofi Development Plan . Development of the Licensed Products in the Sanofi Field for the Territory pursuant to this Agreement shall be conducted pursuant to a comprehensive development plan and budget for such Licensed Product (the “ Sanofi Development Plan ”), which shall include a summary of all clinical studies to be performed for the Licensed Product in the Sanofi Field in the Territory and will include budgets and timelines regarding such activities. The Sanofi Development Plan shall also specify (i) the plans and timeline for preparing the necessary Regulatory Filings and for obtaining Regulatory Approval for the Licensed Product in the Sanofi Field in the Territory and (ii) the Development activities of each Party. Each Party shall conduct its Development activities in accordance with the then-current Sanofi Development Plan. The Sanofi Development Plan will be prepared and approved by the JSC not later than [***] and shall be consistent with Sanofi’s diligence obligations hereunder. Once approved by the JSC, the Sanofi Development Plan will be attached hereto as Exhibit H-1 and incorporated herein by reference.

(b) KaloBios Development Plan . Development of the Licensed Products in the KaloBios Field for the Territory pursuant to this Agreement shall be conducted pursuant to a comprehensive development plan and budget for such Licensed Product to be prepared by KaloBios (the “ KaloBios Development Plan ”), which shall include a summary of all clinical studies to be performed for the Licensed Product in the KaloBios Field in the Territory and will include budgets and timelines regarding such activities and shall also specify the plans and timeline for preparing the necessary Regulatory Filings and for obtaining Regulatory Approval for the Licensed Product in the KaloBios Field in the Territory. KaloBios shall conduct its Development activities in accordance with the then-current KaloBios Development Plan. Once approved by the JSC as soon as practicable following the Effective Date, such KaloBios Development Plan will be attached hereto as Exhibit H-2 and incorporated herein by reference.

 

Page 19 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


4.3 Updates to the Development Plans .

(a) Updates to the Sanofi Development Plan . From time to time during the Term and at least once per calendar year, beginning with the first full calendar year after the Effective Date, Sanofi shall provide KaloBios through the JSC with annual updates to the then-current Sanofi Development Plan. Such annual updated Sanofi Development Plan shall take into account completion or cessation of Development activities or commencement of new Development activities not contemplated by the then-current Sanofi Development Plan. Once approved by the JSC, each updated or amended Development Plan shall become effective and supersede the previous Sanofi Development Plan as of the date of such approval.

(b) Updates to the KaloBios Development Plan . From time to time during the Term and at least once per calendar year, beginning with the first full calendar year after the Effective Date, KaloBios shall provide Sanofi through the JSC, with annual updates to the then-current KaloBios Development Plan. Such annual updated KaloBios Development Plan shall take into account completion or cessation of Development activities or commencement of new Development activities not contemplated by the then-current KaloBios Development Plan. Once approved by the JSC, each updated or amended Development Plan shall become effective and supersede the previous KaloBios Development Plan as of the date of such approval.

4.4 Sanofi Development Activities .

(a) Sanofi shall use Commercially Reasonable Efforts to conduct all Development activities under the Sanofi Development Plan and under the KaloBios Development Plan (in the event the Parties mutually agree that Sanofi will conduct certain Development activities for the Licensed Product in the KaloBios Field), except as may be assigned to KaloBios (the “ Sanofi Development Activities ”), in accordance with the applicable Development Plan and in each case in consultation with the JPT and the JSC. In Europe, Sanofi shall file its initial application for Regulatory Approval with the EMEA.

(b) The status, progress and results of Sanofi’s Development Activities shall be discussed in reasonable detail at meetings of the JPT and the JSC. Upon any discontinuation of the JSC as a result of any of the events described in Section 2.7(b) or 4.11, Sanofi shall keep KaloBios informed as to progress on the Development activities for the Licensed Product in the Sanofi Field by providing KaloBios with written annual reports summarizing the work performed and the timelines regarding such activities.

4.5 KaloBios Development Activities .

(a) KaloBios shall use Commercially Reasonable Efforts to conduct all Development activities under the KaloBios Development Plan and assigned to it in the Sanofi Development Plan (the “ KaloBios Development Activities ”), in accordance with the KaloBios Development Plan and Sanofi Development Plan, respectively, and in each case managed by the JPT and the JSC. KaloBios agrees to perform, and Sanofi agrees to reimburse KaloBios under Section 4.8, for those Development activities described on Exhibit G , including for any such activities performed by KaloBios during the period from January 1, 2010 to the Effective Date.

 

Page 20 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(b) For as long as KaloBios is conducting KaloBios Development activities, the status, progress and results of KaloBios Development Activities shall be discussed in reasonable detail at meetings of the JPT and the JSC.

4.6 Diligence .

(a) Sanofi shall use Commercially Reasonable Efforts to Develop and seek Regulatory Approval of at least one Licensed Product in the Sanofi Field throughout the Territory in accordance with and subject to the terms and conditions of this Agreement.

(b) In the event that Sanofi exercises the Option, then (i) Sanofi also shall use Commercially Reasonable Efforts to Develop and seek Regulatory Approval of at least one Licensed Product in the KaloBios Field in the applicable territory to the extent Sanofi is responsible for such activities in accordance with and subject to the terms and conditions of this Agreement, and (ii) KaloBios shall use Commercially Reasonable Efforts to Develop and seek Regulatory Approval in any applicable territory to the extent KaloBios is responsible for such activities in accordance with and subject to the terms and conditions of this Agreement.

(c) In the event that KaloBios exercises its rights under Section 4.10 or Sanofi exercises its rights under Section 4.11, then Sanofi also shall use Commercially Reasonable Efforts to Develop and seek Regulatory Approval of at least one Licensed Product in the KaloBios Field in the Territory in accordance with and subject to the terms and conditions of this Agreement.

(d) Following agreement by the Parties on the design of the KaloBios Phase 2b Trial, KaloBios shall use Commercially Reasonable Efforts to Develop a Licensed Product through the completion of such KaloBios Phase 2b Trial, which the Parties agree and acknowledge will be satisfied so long as KaloBios has not discontinued Development of such Licensed Product following such agreement as to the design of such KaloBios Phase 2b Trial.

4.7 Compliance .

(a) Each Party agrees that in performing its obligations under this Agreement: (i) it shall comply with all applicable Laws; and (ii) it will not employ or engage any person who has been debarred by any Regulatory Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority. Each Party shall have the right to engage subcontractors for the performance of its obligations under the Development Plan. Each Party shall cause the subcontractor(s) engaged by it to be bound by written obligations of confidentiality and invention assignment consistent with those contained herein, and such Party remains primarily responsible for the performance of such subcontractor(s).

(b) Each Party shall maintain complete, current and accurate records of all work conducted by it under the Development Plan, and all data and other Know-How resulting from such work. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory purposes and the protection of intellectual property rights. Each Party shall document all preclinical studies and clinical trials in formal written study reports according to applicable national and international (e.g., ICH, GCP, GLP, and GMP) guidelines. Each Party shall have the right to review such records maintained by the other Party at reasonable times, upon written request, which shall not exceed once a year.

 

Page 21 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


4.8 Development Costs .

(a) Sanofi Development Costs .

(i) Sanofi shall be responsible for all costs and expenses associated with the Development of the Licensed Products in the Sanofi Field from and after the Effective Date, including those activities to be performed by KaloBios after the Effective Date under the Sanofi Development Plan in accordance with the terms of Section 4.8(a)(ii) below.

(ii) Sanofi agrees to pay KaloBios at the FTE Rate for all KaloBios FTEs who perform Development activities under and in accordance with the Sanofi Development Plan and a mutually agreed budget for the FTE and Non-FTE Development Costs for activities to be performed by KaloBios. In the event KaloBios anticipates that the amount of FTEs and/or Non-FTE Development Costs may exceed an amount equal to [***] of the budget for the associated tasks as set forth in the Sanofi Development Plan during a calendar quarter (such excess, a “ Cost Overrun ”), then KaloBios will notify Sanofi of such anticipated Cost Overrun, and Sanofi will decide in good faith (in consultation with KaloBios) to modify the Sanofi Development Plan to reduce the costs appropriately and/or to increase the budget for such tasks to accommodate such Cost Overrun.

(iii) For so long as KaloBios is performing activities under the Sanofi Development Plan, KaloBios shall provide quarterly written reports to Sanofi on the performance and progress of such activities, together with an invoice setting forth all FTEs and Non-FTE Development Costs incurred in the performance of KaloBios Development Activities in the applicable calendar quarter. Such quarterly reports and invoices shall be submitted within thirty (30) days after the end of the relevant calendar quarter.

(b) KaloBios Development Costs .

(i) KaloBios shall be responsible for all costs and expenses associated with the Development of the Licensed Products in the KaloBios Field (the “ KaloBios Development Costs ”) from and after the Effective Date, including any activities that the Parties agree Sanofi will conduct under the KaloBios Development Plan in accordance with the terms of Section 4.8(b)(ii) below.

(ii) KaloBios agrees to pay Sanofi at the FTE Rate for all Sanofi FTEs who perform Development activities under and in accordance with the KaloBios Development Plan and a mutually agreed budget for the FTE and Non-FTE Development Costs for activities to be performed by Sanofi. In the event Sanofi anticipates that the amount of FTEs and/or Non-FTE Development Costs may exceed an amount equal to [***] of the budget for the associated tasks as set forth in the KaloBios Development Plan during a calendar quarter (such excess, a “ Cost Overrun ”), then Sanofi will notify KaloBios of such anticipated Cost Overrun, and KaloBios will decide in good faith (in consultation with Sanofi) to modify the KaloBios Development Plan to reduce the costs appropriately and/or to increase the budget for such tasks to accommodate such Cost Overrun.

 

Page 22 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(iii) For so long as Sanofi is performing activities under the KaloBios Development Plan, Sanofi shall provide quarterly written reports to KaloBios on the performance and progress of such activities, together with an invoice setting forth all FTEs and Non-FTE Development Costs incurred in the performance of KaloBios Development Activities in the applicable calendar quarter. Such quarterly reports and invoices shall be submitted within thirty (30) days after the end of the relevant calendar quarter.

(c) All payments of amounts invoiced under this Section 4.8 shall be made in accordance with Section 8.9.

4.9 Sanofi Option for Licensed Products in the KaloBios Field .

(a) Option . During the Sanofi Option Period, Sanofi shall have an exclusive option (the “ Option ”) to participate in the Development and Commercialization of the Licensed Products for the KaloBios Field as described in this Section 4.9 in either (i) the Ex-US Countries as described in Section 4.9(b); or (ii) the Ex-US Countries and Fifty Percent (50%) of the US Territory as described in Section 4.9(c). Sanofi may exercise its Option by providing KaloBios written notice in accordance with Section 15.3 and the terms and conditions of this Agreement applicable following such exercise shall be effective as of the date such notice is given in accordance with Section 15.3 (such date, the “ Option Exercise Date ”). Following the completion of the KaloBios Phase 2b Trial, KaloBios shall furnish to Sanofi the final clinical study report from such trial, together with such other information then existing as Sanofi may reasonably request in connection with the evaluation of such trial results in order for Sanofi to determine whether it will exercise the Option.

(b) Ex-US Option Exercise .

(i) Payment Upon Option Exercise . Upon exercise of the Option pursuant to this Section 4.9(b) for the Ex-US Countries, Sanofi shall pay to KaloBios an amount equal to One Hundred Percent (100%) of the KaloBios Development Costs incurred by KaloBios in respect of Development of Licensed Product in the KaloBios Field from and after the Effective Date through the Option Exercise Date. Such payment shall be made in accordance with Section 8.9.

(ii) Obligations of the Parties . Upon exercise of the Option pursuant to this Section 4.9(b), Sanofi will be responsible for the Development of Licensed Products in the KaloBios Field for all countries excluding the U.S. Territory, and KaloBios will be responsible for the Development of Licensed Products in the KaloBios Field for the U.S. Territory. The Parties will collaborate on global Development activities in the KaloBios Field through the JSC and JPTs as applicable. As of the Option Exercise Date, Sections 3.2(c)(ii) and (iii) shall be amended by deleting such provisions and replacing them with the following as a new Section 3.2(c)(ii):

The Parties shall jointly and unanimously decide any matter relating to the KaloBios Development Plan or the Development or Commercialization of Licensed Products in the KaloBios Field affecting or otherwise relating to both of their respective territories. The Parties shall jointly decide any matter regarding the safety of a Licensed Product or that would

 

Page 23 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


materially and adversely potentially impact the regulatory status of Licensed Products in their respective territories. Neither Party shall make any decision regarding Licensed Products within the KaloBios Field in respect of the following critical issues without the consent of the other Party, such consent not to be unreasonably, withheld: (A) adopt any amendment to the KaloBios Development Plan during the twelve (12) month period following the exercise of the Option under Section 4.9(b) that materially changes the scope of the KaloBios Development Plan; (B) discontinue the Development of any such Licensed Product; (C) materially delay or cease to seek Regulatory Approval for any Licensed Product; (D) delay or cancel the commercial launch for any Licensed Product; or (E) remove any Licensed Product from the market other than for safety reasons. The Parties also will use Commercially Reasonable Efforts to share and use clinical data and Confidential Information between them as each may require in order to fulfill their respective Development of Licensed Products in the KaloBios Field.”

(iii) Development and Commercialization Costs . As of the Option Exercise Date following exercise of the Option under this Section 4.9(b), KaloBios and Sanofi shall share the costs of Development (including the KaloBios Phase 2b Trial, it being understood that such trial shall be considered a global trial as described below) and Commercialization of Licensed Products in the KaloBios Field from and after the Option Exercise Date as described in the chart below as and to the extent such costs are set forth in an applicable Sanofi Development Plan or KaloBios Development Plan (and with the designation of the applicable cost sharing category mutually agreed by the Parties prior to commencing such activity, which determination shall not be subject to a Party’s final say right described in Section 3.2):

 

     Sanofi   KaloBios

Global . Development Costs where the data from such trial

is contemplated (at the time such trial is commenced) to be used in a

Regulatory Filing for BOTH the U.S. Territory and any country

within the Ex-US Countries (or the EMEA)

   50%   50%

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

(iv) Royalty to KaloBios for the Ex-US Countries . Following exercise of the Option under Section 4.9(b), Sanofi shall pay to KaloBios a royalty on Net Sales of Licensed Products in the Ex-US Countries in the KaloBios Field equal to Eighteen Percent (18%) of such Net Sales in accordance with the terms of Article 8 (other than Section 8.3(a) and in lieu of the amounts described in Section 8.6 with respect to the Ex-US Countries).

 

Page 24 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(v) Regulatory Filings . As of the Option Exercise Date, Section 5.2(b) shall be amended to reflect that KaloBios shall be responsible for Regulatory Filings within its territory and Sanofi shall be responsible for Regulatory Filings in its territory.

(c) Ex-US + 50% US Option Exercise .

(i) Payment Upon Option Exercise . Upon exercise of the Option pursuant to this Section 4.9(c) for the Ex-US Countries plus fifty percent of the Development and Promotion rights in the U.S. Territory, Sanofi shall pay to KaloBios an amount equal to One Hundred Fifty Percent (150%) of the KaloBios Development Costs incurred by KaloBios from and after the Effective Date in respect of Development of Licensed Product in the KaloBios Field through the Option Exercise Date. Such payment shall be made in accordance with Section 8.9.

(ii) Obligations of the Parties . Upon exercise of the Option pursuant to this Section 4.9(c), Sanofi will be responsible for the Development of Licensed Products in the KaloBios Field for the Ex-US Countries and the Parties will equally share responsibility for conducting the Development of Licensed Products in the KaloBios Field for the U.S. Territory. The Parties will collaborate on global Development activities in the KaloBios Field through the JSC and JPTs, as applicable. As of the Option Exercise Date, Sections 3.2(c)(ii) and (iii) shall be amended by deleting such provisions and replacing them with the following as a new Section 3.2(c)(ii):

“The Parties shall jointly and unanimously decide any matter relating to the KaloBios Development Plan or the Development or Commercialization of Licensed Products in the KaloBios Field; provided however that Sanofi shall have sole discretion with regard to any matters solely affecting the Ex-US Countries (i.e. the territory not shared with KaloBios), [***], in the event that the FDA approves a specific Phase 3 Clinical Trial as a requirement for Regulatory Approval of Licensed Products for sale in the U.S. Territory, then Sanofi shall have the right to proceed with such trial immediately upon receiving such advice from the FDA. Promptly following such determination and Sanofi’s decision to proceed with such trial, [***]. Sanofi shall have final decision making authority on any matter regarding the safety of a Licensed Product or that would materially and adversely potentially impact the regulatory status of a Licensed Product.”

(iii) Development and Commercialization Costs . From and after the Option Exercise Date, following exercise of the Option under this Section 4.9(c), KaloBios and Sanofi shall share the costs and expenses of Development (including the KaloBios Phase 2b Trial, which it being understood that such trial shall be considered a global trial as described below) and Commercialization of Licensed Products in the KaloBios Field as described in the chart below as and to the extent such costs are set forth in an applicable Sanofi Development Plan or KaloBios Development Plan (and with the designation of the applicable cost sharing category mutually agreed by the Parties prior to commencing such activity, which determination shall not be subject to a Party’s final say right described in Section 3.2):

 

Page 25 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


     Sanofi   KaloBios
Global . Development Costs where the data from such trial is contemplated (at the time such trial is commenced) to be used in a Regulatory Filing for BOTH the U.S. Territory and any Ex-US country (or the EMEA)    75%   25%

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

(iv) Profit Share in the U.S. Territory . The Parties shall equally share the profits resulting from the Commercialization of Licensed Products in the KaloBios Field for the U.S. Territory in lieu of the payment provided in Section 8.6 with respect to the U.S. Territory (it being understood that the Parties shall enter into an amendment of this agreement to define the terms of this profit share consistent with the terms of this Agreement).

(v) Royalty to KaloBios for the Ex-US Countries . Following the exercise of the Option pursuant to this Section 4.9(c), Sanofi shall pay to KaloBios a royalty on Net Sales of Licensed Products in the Ex-US Countries in the KaloBios Field equal to Eighteen Percent (18%) of such Net Sales in accordance with the terms of Article 8 (other than Section 8.3(a) and in lieu of the amounts described in Section 8.6 with respect to the Ex-US Countries).

(vi) Regulatory Filings . Following the exercise of the Option pursuant to this Section 4.9(c), Section 5.2(b) shall be amended by deleting references to KaloBios being responsible for Regulatory Filings with Sanofi being responsible for Regulatory Filings. Sanofi will be the lead responsible party for all regulatory matters in the U.S. Territory for Licensed Products in the KaloBios Field and KaloBios shall transfer to Sanofi possession of all material Regulatory Filings for Licensed Products in the KaloBios Field for the U.S. Territory.

4.10 KaloBios Sale of Development and Commercial Rights .

(a) [***].

(b) In connection with such transfer of rights, Sanofi shall pay to KaloBios the following amounts: [***].

 

Page 26 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(c) [***], Sanofi shall pay to KaloBios a royalty on Net Sales of the Licensed Product throughout the world in the KaloBios Field equal to [***] of such Net Sales in accordance with the terms of Article 8 (other than Section 8.3(a)) [***]. For clarity, nothing in this Section 4.10 shall modify Sanofi’s obligations with respect to payments on Licensed Products in the Sanofi Field.

(d) Promptly following receipt of KaloBios’ notice pursuant to this Section 4.10, the Parties shall meet to negotiate in good faith and execute an amendment to this Agreement to address such matters including but not limited to [***].

(e) For greater certainty, in the event of KaloBios’ exercise of its rights pursuant to this Section 4.10, KaloBios shall transfer all such Confidential Information, Know-How, Regulatory Filings and other information and assistance as Sanofi may reasonably require in order to fulfill its diligence obligations in the KaloBios Field and so as to expedite the transition process.

(f) Following exercise by KaloBios of its rights pursuant to this Section 4.10, Sanofi shall keep KaloBios reasonably informed as to its efforts to Develop and Commercialize Licensed Products in the KaloBios Field, that is, Sanofi shall remit to KaloBios a report similar to that required in respect of the Sanofi Field pursuant to Section 6.2(e). All such reports shall be the Confidential Information and proprietary to Sanofi. In its notice pursuant to Section 4.10(a), KaloBios shall provide to Sanofi the contact details of the person(s) to whom such report shall be submitted.

4.11 Sanofi’s Right to Terminate KaloBios’ Rights Under Section 2.2 Upon Change of Control by KaloBios .

(a) In the event that KaloBios is acquired by an Excluded Company in a Change of Control transaction, Sanofi shall have the right to terminate the sub-license granted to KaloBios pursuant to Section 2.2 hereof regarding the Development and Commercialization rights of KaloBios for the Licensed Product in the KaloBios Field for all countries of the world upon notice delivered within ninety (90) days following the consummation of such Change of Control. In the event Sanofi exercises such termination right, KaloBios’ rights under this Agreement to participate in the Development and Commercialization of the Licensed Product for the KaloBios Field shall be terminated, and Sanofi shall assume all Development and Commercialization obligations under this Agreement for Licensed Products in the KaloBios Field (and the Parties shall execute a corresponding amendment to this Agreement).

(b) Upon exercise of its rights under this Section 4.11 prior to first Regulatory Approval of a Licensed Product in the KaloBios Field, Sanofi shall pay to KaloBios the following:

(i) an amount when added to the amounts paid by Sanofi upon exercise of the Option for the Development of the Licensed Product equals a total payment by Sanofi of Two Hundred Fifty Percent (250%) of the KaloBios Development Costs incurred by KaloBios in respect of Development of Licensed Product in the KaloBios Field from and after the Effective Date through the earlier of Sanofi’s exercise of its rights under this Section 4.11 or the date of completion of the KaloBios Phase 2b Trial; and

 

Page 27 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(ii) the lesser of One Hundred Fifty Percent (150%) of that share of the KaloBios Development Costs incurred by KaloBios in respect of Development of Licensed Product in the KaloBios Field from the completion of the KaloBios Phase 2b Trial and Sanofi’s exercise of its rights under this Section 4.11, or, as applicable:

(1) in the event that Sanofi has not exercised its Option, One Hundred Percent (100%) of the KaloBios Development Costs incurred by KaloBios in respect of Development of Licensed Product in the KaloBios Field from the completion of the KaloBios Phase 2b Trial and Sanofi’s exercise of its rights under this Section 4.11 plus Twenty-Five Million Dollars,

(2) in the event that Sanofi has exercised its Option pursuant to Section 4.9(b), One Hundred Percent (100%) of the KaloBios Development Costs incurred by KaloBios in respect of Development of Licensed Product in the KaloBios Field from the completion of the KaloBios Phase 2b Trial and Sanofi’s exercise of its rights under this Section 4.11 plus Twelve and a half Million Dollars, or

(3) in the event that Sanofi has exercised its Option pursuant to Section 4.9(c), One Hundred Percent (100%) of the KaloBios Development Costs incurred by KaloBios in respect of Development of Licensed Product in the KaloBios Field from the completion of the KaloBios Phase 2b Trial and Sanofi’s exercise of its rights under this Section 4.11 plus Six Million and Two Hundred and Fifty Thousand Dollars;

provided however, that in each case of this subpart (ii) that such payments do not include payments already made by Sanofi pursuant to either Sections 4.9(b) or 4.9(c).

(c) Upon exercise of its rights under this Section 4.11 following first Regulatory Approval of a Licensed Product in the KaloBios Field, Sanofi shall pay to KaloBios the greater of (i) the amount set forth in Section 4.11(b) or (ii) the sum of (A) the net present value of projected profits to KaloBios for five (5) years for sale of a Licensed Product in the KaloBios Field calculated as if Sanofi had not exercised its rights under this Section 4.11 minus (B) the net present value of projected worldwide royalties of Eighteen Percent (18%) for five (5) years of Net Sales of a Licensed Product in the KaloBios Field by Sanofi.

(d) From and after the effective date of such termination, Sanofi shall pay to KaloBios a royalty on Net Sales of the Licensed Product throughout the world in the KaloBios Field equal to Eighteen Percent (18%) of such Net Sales in accordance with the terms of Article 8 (other than Section 8.3(a)) (in lieu of the amounts described in Sections 8.3(a) as would have been applicable to the KaloBios Field and 8.6). For clarity, nothing in this Section 4.11 shall modify Sanofi’s obligations with respect to payments on Licensed Products in the Sanofi Field.

(e) Promptly following receipt of Sanofi’s notice pursuant to this Section 4.11 the Parties shall meet to negotiate in good faith and execute an amendment to this Agreement to address such matters including but not limited to KaloBios’ continued involvement in Development and Commercialization of Licensed Products in the Sanofi Field pursuant to the then-current Sanofi Development Plan, the continuation in-part or discontinuation of the JSC and any of the project teams.

 

Page 28 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(f) For greater certainty, in the event of Sanofi’s exercise of its rights pursuant to this Section 4.11, KaloBios shall transfer all such Confidential Information, Know-How, Regulatory Filings and other information and assist Sanofi may it reasonably require in order to fulfill its diligence obligations in the KaloBios Field and so as to expedite the transition process.

(g) Following exercise of its rights pursuant to this Section 4.11, Sanofi shall keep KaloBios reasonably informed as to its efforts to Develop and Commercialize Licensed Products in the KaloBios Field, that is, Sanofi shall remit to KaloBios a report similar to that required in respect of the Sanofi Field pursuant to Section 6.2(e). All such reports shall be the Confidential Information and proprietary to Sanofi. Promptly following receipt of notice from Sanofi pursuant to Section 4.11(a), KaloBios shall provide Sanofi with the contact details of the person(s) to whom such report shall be submitted.

4.12 KaloBios obligation regarding accounting; Sanofi’s right to audit .

(a) KaloBios, its Affiliates and agents shall, during the Term of this Agreement, keep and maintain true and accurate books, records and accounts of all costs associated with the Development of Licensed Products in the KaloBios Field. Sanofi shall have the right, on reasonable notice, to have representatives of a reputable accounting firm review KaloBios’ books, records and accounts in order to independently verify the costs to be paid to KaloBios in accordance with Sections 4.10, 4.11 or 4.12 or any other amounts KaloBios is responsible for under this Agreement. All such records shall be deemed the Confidential Information of KaloBios. In the event that the Parties have any dispute under this provision, each Party may avail itself of the terms of Article 14.

ARTICLE 5

REGULATORY MATTERS

5.1 General .

(a) It is understood and agreed that unless the Parties agree in writing to the contrary, separate INDs and separate DAAs will be filed by Sanofi for the Licensed Product in the Sanofi Field and by KaloBios for the Licensed Product in the KaloBios Field in their respective territories. The Parties agree and acknowledge that the rights and obligations of KaloBios under this Section 5.1 apply for so long as Sanofi has not exercised its Option under Sections 4.9(c), or KaloBios has not exercised its rights under Section 4.10, or Sanofi has not exercised its rights under Section 4.11.

(b) KaloBios shall retain ownership of its IND No. 100,097 and shall be the responsible party maintaining such IND and all filings associated therewith, and Sanofi shall have the right to reference such IND pursuant to Section 5.3 below.

 

Page 29 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


5.2 Preparation of Regulatory Filings .

(a) Licensed Products in the Sanofi Field .

(i) Sanofi shall be the responsible party, at its cost and expense, for filing, in its name, any and all Regulatory Filings for Licensed Products in the Sanofi Field in the Territory, and will hold any such Regulatory Filings in its name. Such Regulatory Filings and related Regulatory Approvals shall be owned solely by Sanofi and Sanofi shall be solely responsible for preparing any and all Regulatory Filings for the Licensed Products in the Sanofi Field in the Territory, subject to the terms of this Article 5. KaloBios shall assist Sanofi as it may reasonably request in connection with the preparation and filing of such Regulatory Filings, at Sanofi’s expense.

(ii) Sanofi shall keep KaloBios regularly informed, through the JSC, of material regulatory developments specific to Licensed Products in the Sanofi Field throughout the Territory. Sanofi shall provide to KaloBios all information as reasonably necessary in order for KaloBios to carry out its rights and obligations hereunder.

(iii) To the extent permitted by FDA and/or EMEA and reasonably requested by KaloBios, Sanofi shall allow a designated representative of KaloBios reasonably acceptable to Sanofi to participate, as a silent observer, in any significant meeting between Sanofi and the FDA and/or EMEA primarily related to any Licensed Product.

(b) Licensed Products in the KaloBios Field .

(i) KaloBios shall be the responsible party, at its cost and expense, for filing, in its name, any and all Regulatory Filings for Licensed Products in the KaloBios Field in the Territory, and will hold any such Regulatory Filings in its name. Such Regulatory Filings and related Regulatory Approvals shall be owned solely by KaloBios and KaloBios shall be solely responsible for preparing any and all Regulatory Filings for the Licensed Product in the KaloBios Field in the Territory, subject to the terms of this Article 5. Sanofi shall assist KaloBios as it may reasonably request in connection with the preparation and filing of such Regulatory Filings, at KaloBios’ expense.

(ii) KaloBios shall keep Sanofi regularly informed, through the JSC, of material regulatory developments specific to Licensed Products in the KaloBios Field throughout the Territory. KaloBios shall provide to Sanofi all information as reasonably necessary in order for Sanofi to carry out its rights and obligations hereunder.

(iii) To the extent permitted by FDA and/or EMEA and reasonably requested by Sanofi, KaloBios shall allow a designated representative of Sanofi reasonably acceptable to KaloBios to participate, as a silent observer, in any significant meeting between KaloBios and the FDA and/or EMEA primarily related to any Licensed Product.

5.3 Sharing of Data; Rights of Reference . Each Party shall promptly provide the other Party with copies of final reports and of all Confidential Information (including preclinical and clinical data) generated by or on behalf of a Party in conducting any Development activities in support of Regulatory Approval with respect to Licensed Products in the Sanofi Field and

 

Page 30 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


Licensed Products in the KaloBios Field. Each Party shall provide such Confidential Information to the other Party as soon as reasonably practical and through information sharing procedures to be established by the JSC; provided however that a Party shall have the right to withhold disclosure of information included within the chemistry, manufacturing and controls section of a Party’s Regulatory Filing and other sensitive and proprietary trade secrets of a Party as reasonably necessary to protect such rights (excluding in any case preclinical and clinical data). Each Party shall submit directly to Regulatory Authorities any information included within the chemistry, manufacturing and controls section of a Party’s Regulatory Filing and other sensitive and proprietary trade secrets of a Party as reasonably necessary to protect such rights required for the purpose of seeking, obtaining and maintaining Regulatory Approvals for the Licensed Products in the Field of the other Party. By doing such data transfer directly to Regulatory Authorities such Party agrees to answer any inquiries from the Regulatory Authorities related to such data within a reasonable timeframe and agrees to any inspection requested by such Regulatory Authorities related to such submitted data. Each Party hereby grants to the other Party, and agrees to confirm such grant in writing as may be required for submission to a Regulatory Authority, a right of reference to all Regulatory Filings filed by such Party for the Licensed Product solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, Licensed Products in the Territory, consistent with the roles of the Parties set forth in this Agreement. Upon expiration or termination of the Option, Sanofi may request, and KaloBios shall reasonably implement, limitations on the disclosure of Confidential Information generated by or on behalf of a Party in conducting any Development activities in support of Regulatory Approval with respect to Licensed Products in the Sanofi Field and Licensed Products in the KaloBios Field.

5.4 Adverse Events . Promptly following the Effective Date, the Parties shall enter into an agreement regarding pharmacovigilance and adverse event reporting setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Product, to include at least provisions governing the establishment and maintenance of a global safety database for Licensed Products, safety data sharing, adverse events reporting and prescription events monitoring (the “ Safety Data Exchange Agreement ”).

5.5 Recalls . In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Licensed Product in the Sanofi Field or a Licensed Product in the KaloBios Field, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or other corrective action regarding a Licensed Product in the Sanofi Field or a Licensed Product in the KaloBios Field, such Party shall promptly advise the other Party by telephone or facsimile. Sanofi shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it shall be required) or to take other corrective action in any country and the manner in which any such recall, market withdrawal or corrective action shall be conducted. Sanofi shall be responsible for all costs and expenses associated with such recall, market withdrawal or corrective action and shall keep KaloBios regularly informed regarding any such actions.

5.6 Coordination of Manufacturing Changes . If either Party makes a change with respect to the manufacture of a Licensed Product by such Party or on its behalf in accordance with Article 7 hereof, and such change is reported to a Regulatory Authority, then such Party shall notify the other Party about such change in advance of the date that it reports such change to the applicable Regulatory Authority and shall promptly provide the other Party with a copy of the report filed with such Regulatory Authority with respect to such change.

 

Page 31 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 6

COMMERCIALIZATION

6.1 Commercialization in the Territory .

(a) Licensed Products in the Sanofi Field . Sanofi will be solely responsible for all aspects of the Commercialization of Licensed Products, at its expense, in the Sanofi Field in the Territory and [***].

(b) Licensed Products in the KaloBios Field . KaloBios shall be solely responsible for Promotion of Licensed Products, at its expense, in the KaloBios Field in the Territory. Sanofi will be solely responsible for all other aspects of the Commercialization of Licensed Products, at its expense, in the KaloBios Field in the Territory, [***]. Sanofi shall be entitled to deduct the costs and expenses of such Commercialization activities from amounts paid to KaloBios in respect of the sale of Licensed Products in accordance with the terms of Section 8.6.

(c) Following Option/Rights Exercise .

(i) In the event that Sanofi exercises its option under Section 4.9(b) and subject to Sections 4.9(b)(iii) then [***].

(ii) In the event that Sanofi exercises its option under Section 4.9(c) and subject to Sections 4.9(c)(iii), [***].

(iii) In the event that KaloBios exercises its rights under Section 4.10 or Sanofi exercises its rights under Section 4.11, [***].

6.2 Sanofi Performance for Licensed Products in the Sanofi Field and KaloBios Field .

(a) Commercial Diligence . Sanofi shall devote Commercially Reasonable Efforts to Commercialize at least one Licensed Product in the Sanofi Field throughout the Territory following Regulatory Approval of the Licensed Product in the Sanofi Field in the Territory in accordance with this Agreement. Without limiting the foregoing, Sanofi shall use Commercially Reasonable Efforts to achieve First Commercial Sale of the Licensed Product in the Sanofi Field in a country for which it has received Regulatory Approval within [***] the receipt of such Regulatory Approval.

(b) In the event that Sanofi exercises the Option under Section 4.9(b) or (c), then Sanofi also shall use Commercially Reasonable Efforts to Commercialize [***] Licensed Product in the KaloBios Field throughout the applicable territory for which Sanofi exercised its Option following Regulatory Approval of the Licensed Product in the applicable territory in

 

Page 32 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


accordance with this Agreement. Without limiting the foregoing, Sanofi shall use Commercially Reasonable Efforts to achieve First Commercial Sale of the Licensed Product in the KaloBios Field in a country for which it has received Regulatory Approval within [***] the receipt of such Regulatory Approval. In addition, Sanofi and KaloBios shall each use Commercially Reasonable Efforts to Promote [***] Licensed Product in the KaloBios Field where they have joint Promotion rights in any such territory.

(c) In the event that either KaloBios exercises its rights under Section 4.10 [***].

(d) Sanofi Commercialization Plan . Sanofi shall Commercialize the Licensed Products in the Sanofi Field and the KaloBios Field (for which it has exercised its Option or obtained rights in accordance with either Section 4.10 or 4.11) in the Territory pursuant to a plan (the “ Sanofi Commercialization Plan ”) prepared by Sanofi and submitted to the JSC for information purposes only reasonably prior to the anticipated launch of the Licensed Product in the Sanofi Field. The Sanofi Commercialization Plan will include summary information consistent with Sanofi’s internal practices regarding its proposed Commercial activities and budgets and timelines therefor. On at least an annual basis and for so long as KaloBios retains rights to Commercialize the Licensed Product in the KaloBios Field, Sanofi shall update and amend, as appropriate, the then-current Sanofi Commercialization Plan. Such updated and amended Sanofi Commercialization Plan shall reflect any changes, re-prioritization of activities within, reallocation of resources with respect to, or additions to Commercialization of the Licensed Product in the Sanofi Field. The amended Sanofi Commercialization Plan shall be submitted to the JSC for its information.

(e) Reports . Sanofi shall update the JSC (if the JSC is discontinued, then to KaloBios) periodically regarding Sanofi’s Commercialization activities with respect to the Licensed Product in the Sanofi Field in the Territory. Sanofi shall present a written report each year summarizing Sanofi’s Commercialization activities with respect to the Licensed Product in the Sanofi Field in the Territory pursuant to this Agreement, covering subject matter at a level of detail sufficient to enable KaloBios to determine Sanofi’s compliance with its diligence obligations pursuant to this Section 6.2.

6.3 KaloBios Performance for Licensed Products in the KaloBios Field .

(a) Commercial Diligence . KaloBios shall devote Commercially Reasonable Efforts to Promote [***] Licensed Product in the KaloBios Field throughout the Territory following Regulatory Approval of the Product in the KaloBios Field in the Territory in accordance with this Agreement. Without limiting the foregoing, KaloBios shall use Commercially Reasonable Efforts to achieve First Commercial Sale of the Licensed Product in the KaloBios Field in a country for which Regulatory Approval has been granted within [***] the receipt of such Regulatory Approval.

(b) KaloBios Commercialization Plan . KaloBios shall Promote the Licensed Products in the KaloBios Field in the Territory pursuant to a plan (the “ KaloBios Commercialization Plan ”) prepared by KaloBios and submitted to the JSC reasonably prior to the anticipated launch of the Licensed Product in the KaloBios Field. The KaloBios

 

Page 33 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


Commercialization Plan will include summary information consistent with KaloBios’ internal practices regarding its proposed Promotional activities (including market studies, launch plans, detailing and promotion) and budgets and timelines therefor. On at least an annual basis, KaloBios shall update and amend, as appropriate, the then-current KaloBios Commercialization Plan. Such updated and amended KaloBios Commercialization Plan shall reflect any changes, re-prioritization of activities within, reallocation of resources with respect to, or additions to Promotion of the Licensed Product in the KaloBios Field. The amended KaloBios Commercialization Plan shall be submitted to the JSC for its review and, if Sanofi exercises its Option pursuant to Section 4.9(c), then KaloBios shall submit any amended Commercialization Plan to the JSC for its review and approval.

(c) Reports . KaloBios shall update the JSC (if the JSC is discontinued, to Sanofi) periodically regarding KaloBios’ Commercialization activities with respect to the Licensed Product in the KaloBios Field in the Territory. KaloBios shall present a written report each year summarizing KaloBios’ Commercialization activities with respect to the Licensed Product in the KaloBios Field in the Territory pursuant to this Agreement, covering subject matter at a level of detail reasonably requested by KaloBios and sufficient to enable KaloBios to determine KaloBios’ compliance with its diligence obligations pursuant to this Section 6.3.

(d) In the event that Sanofi exercises its Option, then the terms of this Section 6.3 shall continue to apply only to the U.S. Territory and not the Ex-US Countries. In the event that KaloBios exercises its right under Section 4.10 [***].

6.4 Sanofi Performance for Licensed Products in the Sanofi Field and in the KaloBios Field . Without limiting the generality of Sanofi’s obligations under Section 6.1 or elsewhere in this Agreement, Sanofi shall have the following obligations with respect to the Commercialization of the Licensed Products:

(a) Pricing . [***].

(b) Booking of Sales . [***] in accordance with applicable generally acceptable accounting standards of France or US GAAP, consistently applied and as applicable to the booking of such sales for a particular territory, including handling inventory, receivables, managing relationships with the trade, returns, reimbursements, and charge-backs, trade-customer complaints and inquiries with respect to such Licensed Products [***].

(c) Sales and Distribution . [***].

(d) Sales Adjustment Mechanism . [***].

6.5 Licensed Product Labeling and Promotional Materials .

(a) Sanofi shall be solely responsible for designing and supplying the product labeling and promotional materials for the Licensed Products in the Sanofi Field in the Territory. Sanofi shall provide samples of such labeling and materials to the JSC for review for so long as KaloBios retains rights to Promote Licensed Products in the KaloBios Field. Sanofi shall own all right, title and interest in and to any and all such promotional materials, including all applicable Marks.

 

Page 34 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(b) For so long as KaloBios retains its right to Promote the Licensed Products exclusively in an applicable territory, KaloBios shall be responsible, in consultation with Sanofi, for designing and supplying the product labeling and promotional materials for the Licensed Products in the KaloBios Field in such applicable countries of the Territory. KaloBios shall provide samples of such labeling and materials to the JSC for review prior to finalizing such materials for use by the Parties’ sales representatives. KaloBios shall own all right, title and interest in and to any and all such promotional materials, including all applicable Marks, and shall assign all such right, title and interest in and to such materials in the event the KaloBios exercises its rights pursuant to Section 4.10 or Sanofi exercises its rights pursuant to Section 4.11.

(c) For so long as KaloBios retains its right to Promote the Licensed Products co-exclusively in an applicable territory, KaloBios and Sanofi shall be jointly responsible for designing and supplying the product labeling and promotional materials for the Licensed Products in the KaloBios Field in such applicable countries of the Territory, provided that in the case of any dispute Sanofi shall have final say. Sanofi shall own all right, title and interest in and to any and all such promotional materials, including all applicable Marks, and shall grant a royalty free license to KaloBios to use such materials to enable KaloBios to carry out its obligations hereunder. KaloBios and Sanofi shall provide samples of such labeling and materials to the JSC for review prior to finalizing such materials for use by the Parties’ respective sales representatives.

(d) The Parties shall describe in the applicable Commercialization Plan how and the manner in which the Parties shall be presented and described to the medical community in any promotional materials and the placement of the names and logos of the Parties therein, in each case as permitted by applicable Law and in accordance with the labeling for the Licensed Products in the Sanofi Field and in the KaloBios Field approved by the applicable Regulatory Authority. Notwithstanding the licenses granted herein, neither Party shall have the right to license to any Third Party any intellectual property rights covering any materials developed by a Party for the Commercialization of Licensed Products for a particular territory, unless the Parties otherwise agree.

ARTICLE 7

MANUFACTURING

7.1 Manufacture of Licensed Products for the Sanofi Field . Subject to the provision of certain interim supply of Licensed Product by KaloBios as described in Section 7.3, Sanofi shall be responsible for the manufacture of Licensed Products in the Sanofi Field for use in Development and Commercialization of Licensed Products. Sanofi shall be responsible for all costs and expenses in connection with the manufacturing and supply of the Licensed Products in the Sanofi Field after the Effective Date, including all Clinical Lot Manufacturing Costs, the cost of qualifying its facilities, and the cost of qualifying a Third Party supplier for manufacture of the Licensed Product in the Sanofi Field, if necessary.

 

Page 35 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


7.2 Manufacture of Bulk Substance for the KaloBios Field . Sanofi shall be responsible for the manufacture of Bulk Substance for the KaloBios Field and KaloBios shall be responsible for any further formulation and processing (e.g. filling and packaging) for use in Development and Commercialization; provided that in the event Sanofi exercises its Option under either Section 4.9(b) or 4.9(c), after a reasonable transition period to enable Sanofi to manufacture Licensed Product in the KaloBios Field, then Sanofi shall supply final finished form of the Licensed Product for use in Development and Commercialization following the exercise of such Option. Sanofi will supply Bulk Substance (or final finished form of Licensed Product as applicable) to KaloBios, its Affiliates and sublicensees, and such parties will purchase Bulk Substance (or final finished form of Licensed Product as applicable) from Sanofi for Development and Commercialization purposes, subject to the terms of a supply agreement to be negotiated in good faith by the Parties following the Effective Date (the “ Supply Agreement ”) upon the request of either Party. Such Supply Agreement will contain the following material terms and other terms as are customary for an agreement of this type: (a) Sanofi shall supply Bulk Substance (or finished form of Licensed Product as applicable) for Development purposes [***] if Sanofi is unable or unwilling to supply such Bulk Substance or Licensed Product in accordance with the amounts forecasted by KaloBios under a mechanism to be established in the Supply Agreement and in accordance with the terms of the Supply Agreement, KaloBios shall have the right to itself manufacture or have manufactured Bulk Substance or finished form of Licensed Product[***]. Upon the reasonable request of KaloBios, the Parties shall amend the Supply Agreement to include terms governing the supply to KaloBios of Bulk Substance (or finished form of Licensed Product as applicable) by or on behalf of Sanofi for commercial sale to Third Parties. For the sake of clarity Sanofi shall have the right to contract part or all of the manufacturing of the License Products to Third Parties.

7.3 Interim Supply of Licensed Product to Sanofi . The Parties acknowledge that KaloBios may supply Sanofi (either by itself or through its Third Party manufacturer) with those certain quantities of the Licensed Product as and to the extent agreed by both Parties set forth in the Sanofi Development Plan. To the extent KaloBios supplies such Licensed Product, [***]. The purchase and supply of Licensed Product shall be subject to the terms and conditions of KaloBios’ Third Party supply agreements and will be governed by a purchase order containing standard terms and conditions to be executed by the Parties as needed following the Effective Date.

7.4 Technology Transfer . Not later than [***], KaloBios shall, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to, make available and transfer copies of Confidential Information and certain tangible materials to the extent Controlled by KaloBios and necessary to the manufacture of the Licensed Product (the “ Manufacturing Know-How ”). Sanofi will use such Manufacturing Know-How solely as permitted under the licenses granted herein to manufacture or have manufactured Licensed Product. Such transfer shall be conducted at Sanofi’s expense, in accordance with a written plan describing the activities, timelines and budget necessary to conduct such transfer and the estimated timeline therefor. [***].

7.5 Enablement . In the event that Sanofi cannot make or have made the Bulk Substance or Licensed Products, as applicable, in accordance with the terms of the Supply Agreement, the grant to KaloBios in Section 2.2 shall automatically include the right for KaloBios to make or have made such Bulk Substance or Licensed Product (as applicable).

 

Page 36 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 8

FINANCIAL PROVISIONS

8.1 Upfront Fee . As partial consideration for the grant of the licenses and rights under this Agreement to the KaloBios Technology and the Development activities of KaloBios prior to the Effective Date, Sanofi shall pay to KaloBios a one-time, non-refundable and non-creditable upfront fee of Forty Million Dollars ($40,000,000) in the following installments: (i) Thirty Five Million Dollars ($35,000,000) payable, in accordance with Section 8.9, after the Effective Date; and (ii) Five Million Dollars ($5,000,000) payable,[***].

8.2 Milestone Payments . Sanofi shall make the following milestone payments to KaloBios after the achievement of the applicable milestone event for a Licensed Product in the Sanofi Field as set forth in this Section 8.2. Each milestone payment by Sanofi to KaloBios hereunder shall be payable only on the first occurrence of such milestone event for the first Licensed Product only, regardless of the number of Licensed Products Developed or Indications for which Licensed Products are used. [***]. For purposes of this Section 8.2, “ Successful Completion ” means, for any applicable clinical study, [***]. If in a calendar year, Sanofi achieves more than one sales milestone, then [***].

 

Milestone Event

         Milestone Payment  
    Regulatory Milestones       

1. Dosing of the first patient in the first Phase 2b Clinical Trial

   $ 5,000,000   

2. Successful completion of the first Phase 2b Clinical Trial

   $ 20,000,000   

3. [***]

       [***]   

4. [***]

       [***]   

5. [***]

       [***]   

6. [***]

       [***]   

7. [***]

       [***]   
 

[***]

  

1. [***]

       [***]   

2. [***]

       [***]   

3. [***]

       [***]   

8.3 Royalties .

(a) Royalty Rates . On each Licensed Product in the Sanofi Field for which there exists a Valid Claim, Sanofi will pay to KaloBios a running royalty at the following royalty rates, on Net Sales of such Licensed Products in the Sanofi Field in all countries of the Territory during the Royalty Term (as defined in Section 8.3(c), below). In addition, the foregoing royalty

 

Page 37 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


shall be payable for Net Sales of Licensed Products in the KaloBios Field in the event of any termination by Sanofi of the rights and licenses granted under Section 2.2 of this Agreement to KaloBios for the Licensed Product in the KaloBios Field.

 

[***]    Royalty Rate

[***]

   12%

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   17%

(b) Deduction For No Valid Claims . The royalty rates set forth in Sections 8.3(a), 4.9(b)(iv) and 4.9(c)(v), respectively, for the sale of a Licensed Product in a particular country during the Royalty Term shall be reduced for such country by [***] in the event that the Licensed Product is not covered or claimed in any Valid Claim of any KaloBios Patent or Patent covering any Joint Invention in such country or Regulatory Exclusivity. Notwithstanding the foregoing, if a claim of a KaloBios Patent application has been pending in a particular country for [***] from the time of national filing [***], or Regulatory Exclusivity applicable to such Licensed Product has been granted in such country, then Sanofi shall pay royalties in respect of such KaloBios Patent application in such country as if it were a Valid Claim (and pay the royalties due under Section 8.3(a)) for [***] from the time of national filing of such patent. In addition, if after such [***] period, a Patent issues in such country then from and after such date the terms of Section 8.3(a) shall apply (with royalties payable from the expiration of the [***] period).

(c) Royalty Term . The royalty payment obligation under Sections 8.3(a), 4.9(b)(iv), 4.9(c)(v) and 4.10(c), respectively, shall apply, on a country-by-country and Licensed Product-by-Licensed Product basis, during the period of time beginning upon the First Commercial Sale of such Licensed Product in such country, and ending upon the later of (i) ten (10) years from First Commercial Sale of such Licensed Product in such country and (ii) the expiration of the last-to-expire Valid Claim of any KaloBios Patent or Patent covering any Joint Invention in such country (such period, the “ Royalty Term ”).

(d) In the event that a Governmental Authority grants a period of Regulatory Exclusivity covering a Licensed Product, then to the extent that such Licensed Product is not otherwise covered by one or more Valid Claims, it shall, for the purpose of calculating royalties hereunder, be considered as if it were covered by one or more Valid Claims in the jurisdiction where such Regulatory Exclusivity applies.

8.4 Existing Third Party Licenses . KaloBios will be responsible for all amounts owed to Third Parties after the Effective Date pursuant to Third Party Licenses entered into prior to the Effective Date; [***].

8.5 Future Third Party Licenses . [***].

 

Page 38 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


8.6 Payments for Licensed Products in the KaloBios Field . For any territory where Sanofi has not exercised its Option under Section 4.9 and KaloBios retains the right to Promote the Licensed Product in the KaloBios Field, Sanofi shall pay to KaloBios [***] received by or on behalf of Sanofi for sales of Licensed Products within the KaloBios Field less Sanofi’s direct costs incurred in the [***] of the Licensed Products in the KaloBios Field (to include a reasonable allocation of general and administrative costs allocable to such [***] and the costs of such other Commercialization activities that Sanofi agrees to perform under this Agreement. Such payments to KaloBios will commence on First Commercial Sale of Licensed Products and will continue for so long as Licensed Products are sold in any country in the KaloBios Field.

8.7 Royalty Payments and Reports . Within forty-five (45) days after the end of each calendar quarter, Sanofi shall deliver to KaloBios a report containing the following information for such calendar quarter:

(a) the number of units of Licensed Products sold by Sanofi, its Affiliates and/or its sublicensees;

(b) the gross sales associated with each Licensed Product sold by Sanofi, its Affiliates and/or its sublicensees;

(c) a calculation of Net Sales of each Licensed Products that are sold by Sanofi, its Affiliates and (if applicable) its sublicensees; and

(d) a calculation of payments due to KaloBios with respect to the foregoing.

Concurrent with these reports, Sanofi shall remit to KaloBios any royalty payment due for the applicable calendar quarter. If no royalties are due to KaloBios for such reporting period, the report shall state this.

8.8 Foreign Exchange . The rate of exchange to be used in computing the amount of currency equivalent in Dollars of Net Sales invoiced in other currencies shall be made at the average of the daily closing exchange rates reported in The Wall Street Journal (U.S., Western Edition) over the applicable reporting period for the payment due.

 

Page 39 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


8.9 Invoicing; Payment Method; Late Payments . All invoices for any payments to be made hereunder shall be directed as follows:

 

Original to:

Sanofi Pasteur S.A.

2, avenue Pont Pasteur

69007 Lyon, France

Attention: Accounts Payable

  

with pdf copies via email to:

[***]

Original to:

KaloBios Pharmaceuticals, Inc.

260 East Grand Avenue

South San Francisco, CA 94080

U.S.A.

Attention: Accounts Payable

  

with pdf copies via email to:

[***]

Invoices shall be payable by either Party within thirty (30) days end of the month following the date of receipt of the invoice (such date, the “ Payment Date ”). For example, if a Party delivers an invoice to the other Party on January 15th, then the other Party would be required to pay such invoice not later than thirty (30) days from January 31st.

All payments due to a Party hereunder shall be paid in Dollars and made by wire transfer of immediately available funds into an account designated by such Party not later than the Payment Date for such invoice, except for any payments disputed in good faith by a Party pursuant to the terms of Article 14.

Any payments or portions thereof due hereunder that are not received by a Party on the date such payments are due under this Agreement shall bear interest at a rate equal to the lesser of: (a) [***] percentage points above the Prime Rate as published by Citibank, N.A., New York, New York, or any successor thereto, at 12:01 a.m. on the first day of each calendar quarter in which such payments are overdue; or (b) the maximum rate permitted by Law, in each case calculated on the number of days such payment is delinquent, compounded monthly.

To the extent a Party disputes any amount hereunder, it shall immediately notify the other Party and such Party shall provide a revised invoice in respect of only the undisputed portion if necessary in order for the disputing Party to process payment. No late payment shall apply for any period of time taken by a Party to generate such revised invoice for an undisputed payment or until any other relevant documentation required in order to validate the disputing Party’s obligation to make payment (e.g. reports) is received from the other Party.

8.10 Records; Audits . Sanofi will maintain complete and accurate records in sufficient detail to permit KaloBios to confirm the correct amount of all payments owed under this Agreement including all royalty and milestone payments. Upon reasonable prior notice, such records shall be available during regular business hours for a period of three (3) years from the end of the calendar year to which they pertain for examination at the expense of KaloBios, and not more often than once each calendar year, by an independent certified public accountant selected by KaloBios and reasonably acceptable to Sanofi, for the sole purpose of verifying the correct amount of the milestone and royalty payments owed by Sanofi pursuant to this Agreement. Any such auditor shall not disclose Sanofi’s Confidential Information to KaloBios or

 

Page 40 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


any Third Party, except to the extent such disclosure is necessary to accomplish such purpose. Any amounts shown to be owed but unpaid shall be paid by Sanofi in accordance with Section 8.9 following receipt of the accountant’s report, plus amounts due under Section 8.9. KaloBios shall be responsible for the full cost of such audit unless such audit discloses an underpayment by Sanofi of more than [***] of the amount due, in which case Sanofi shall be responsible for the full cost of such audit.

8.11 Taxes .

(a) Taxes on Income . Each Party shall be solely responsible for the payment of all taxes it is liable for.

(b) Tax Cooperation . The Parties agree to cooperate with one another and use reasonable efforts to avoid or reduce tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by Sanofi to KaloBios under this Agreement. To the extent Sanofi is required to deduct and withhold taxes on any payment to KaloBios, Sanofi shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner, deduct this amount from the payment due to KaloBios and promptly transmit to KaloBios evidence of such withholding sufficient to enable KaloBios to claim any amount allowed by its own tax authorities. In order to benefit from the provisions of the double tax treaty between France and the United States, KaloBios will complete and sign the Certificate of Residence and Application for a Reduction of Withholding Tax on Royalties forms (the “ Tax Forms ”) and send them to Sanofi via email to [***] and to [***] the attention of the Tax Department immediately upon the Effective Date and every January thereafter during the Term. In the event KaloBios fails to promptly return such forms duly completed and signed, Sanofi will notify KaloBios in via email to [***] and in writing via overnight mail to the address listed in Section 15.3, that it must send such forms to Sanofi. If, after thirty (30) days of such written notice to KaloBios, Sanofi has not received such documents, Sanofi will declare and pay withholding tax at the common rate of the applicable corporate income tax, and such tax will then be deducted from the corresponding payment by Sanofi to KaloBios, proof of payment will be sent to KaloBios as evidence of such payment. Should Sanofi delay any payments under this Agreement due to the absence of receipt of such documents from KaloBios, the provisions of Section 8.9 regarding late payments shall not apply to such payments.

8.12 Non-Monetary Consideration . In the event Sanofi receives any non-monetary consideration in connection with the sale of a Licensed Product, Sanofi’s payment obligations under this Article 8 shall be based on the fair market value of such other consideration. In such case, Sanofi shall disclose the terms of such arrangement to KaloBios and the Parties shall endeavor in good faith to agree on such fair market value.

8.13 Blocked Currency . In each country where the local currency is blocked and cannot be removed from the country, royalties accrued in that country shall be paid to KaloBios in Dollars based on the Dollar reported sales for the quarter in accordance with applicable Laws and accounting standards, unless otherwise mutually agreed.

 

Page 41 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 9

INTELLECTUAL PROPERTY

9.1 Ownership of Inventions . Each Party shall own all right, title and interest in and to any inventions invented solely by its own employees, agents, or independent contractors in the course of conducting its activities under this Agreement, together with all intellectual property rights therein (“ Sole Inventions ”). Each Party shall own an undivided one-half interest in and to any inventions that are invented jointly by employees, agents, or independent contractors of both Parties in the course of performing activities under this Agreement, together with all intellectual property rights therein (“ Joint Inventions ”). Inventorship shall be determined, where necessary, in accordance with U.S. patent Laws. All Patents claiming jointly owned Joint Inventions shall be referred to herein as “ Joint Patents .”

9.2 Disclosure of Inventions . Each Party shall promptly disclose to the other any invention disclosure memoranda, or other similar documents, submitted to it by its employees, agents or independent contractors describing inventions that are either Sole Inventions or Joint Inventions, and all Confidential Information relating to such inventions to the extent necessary for the preparation, filing and maintenance of any Patent with respect to such invention.

9.3 Assignment of KaloBios Platform Inventions . Notwithstanding anything to the contrary in Section 9.1, in the event that Sanofi, its sublicensee or someone acting on its/their behalf invents an improvement to the KaloBios Platform (whether solely or jointly with KaloBios) with access to or use of any of KaloBios’ Confidential Information, then Sanofi shall assign to KaloBios, for no additional consideration, all right, title and interest in and to any such invention; provided that, Sanofi shall have no obligation to assign any such invention if such assignment would violate applicable Law or any agreement with a Third Party; and further provided however, that KaloBios hereby grants Sanofi a worldwide, perpetual, irrevocable, fully paid non-exclusive license (without the right to grant sublicenses except to its Affiliates) to use any such invention for any purpose. From and after the Effective Date, Sanofi shall use Commercially Reasonable Efforts to ensure that each Third Party agreement entered into by Sanofi or its Affiliates with respect to the Licensed Products contains terms such that KaloBios will receive the assignment described in this Section 9.3 and in no event will Sanofi knowingly enter into a Third Party agreement that does not give KaloBios rights equivalent to Sanofi with respect to any improvement to the KaloBios Platform. In the event that Sanofi, its sublicensee or someone acting on its behalf invents an improvement to any KaloBios Platform (whether solely or jointly with KaloBios) without use of or access to any of KaloBios’ Confidential Information (an “ Independent KaloBios Platform Invention ”), then the Parties shall negotiate in good faith a license on commercially reasonable terms to any such invention (with the right to grant sublicenses through multiple tiers) for any and all uses to the extent allowed by applicable law; provided however that Sanofi covenants during the pendency of such negotiation not to sue KaloBios, its Affiliates or any Third Party sublicensee under any Independent KaloBios Platform Invention.

 

Page 42 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


9.4 Prosecution of Patents .

(a) KaloBios Patents .

(i) Subject to Section 9.4(a)(ii) below, KaloBios shall have the sole right to prepare, file, prosecute and maintain KaloBios Patents that are not Joint Patents (the “ KaloBios Prosecuted Patents ”), at its own expense. KaloBios shall provide Sanofi with a copy of material communications from any patent authority regarding KaloBios Prosecuted Patents, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses for Sanofi’s review and comment. KaloBios shall reasonably consider such comments by Sanofi in connection with the prosecution of KaloBios Prosecuted Patents, and shall implement as appropriate such reasonable comments by Sanofi with respect to KaloBios Prosecuted Patents that cover solely the Licensed Products licensed to Sanofi hereunder.

(ii) If KaloBios decides to cease the prosecution or maintenance of any KaloBios Prosecuted Patents that are necessary to use, manufacture, sell, offer to sell or export Licensed Products in the Sanofi Field, it shall notify Sanofi in writing sufficiently in advance so that Sanofi may, at its discretion, assume the responsibility for the prosecution or maintenance of such KaloBios Prosecuted Patents, at Sanofi’s sole expense. Such Patents shall be included in the Sanofi Prosecuted Patents and the terms of Section 9.4(b) shall apply to such Patents.

(iii) The Parties’ rights under this Section 9.4(a) with respect to the KaloBios Patents licensed to KaloBios by a Third Party shall be subject to the rights of such Third Party to file, prosecute, and/or maintain such KaloBios Patent as required by any Third Party License.

(b) Sanofi Patents .

(i) Subject to Section 9.4(b)(ii) below, Sanofi shall have the sole right to prepare, file, prosecute and maintain Sanofi Patents that are not Joint Patents (the “ Sanofi Prosecuted Patents ”), at its own expense. Sanofi shall provide KaloBios with a copy of material communications from any patent authority regarding Sanofi Prosecuted Patents, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses for KaloBios’ review and comment. Sanofi shall reasonably consider such comments by KaloBios in connection with the prosecution of Sanofi Prosecuted Patents, and shall implement as appropriate such reasonable comments by KaloBios with respect to Sanofi Prosecuted Patents that cover solely the Licensed Products hereunder.

(ii) If Sanofi decides to cease the prosecution or maintenance of any Sanofi Prosecuted Patents, it shall notify KaloBios in writing sufficiently in advance so that KaloBios may, at its discretion, assume the responsibility for the prosecution or maintenance of such Sanofi Prosecuted Patents, at KaloBios’ sole expense. Such Patents shall be included in the KaloBios Prosecuted Patents and the terms of Section 9.4(a) shall apply to such Patents.

(iii) The Parties’ rights under this Section 9.4(b) with respect to any Sanofi Patent licensed from a Third Party shall be subject to the rights of such Third Party to file, prosecute, and/or maintain such Sanofi Patent as required by any license agreement with such Third Party.

 

Page 43 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(c) Joint Patents . The Parties agree to appoint independent external counsel to prosecute Joint Patents. The costs of such counsel shall be borne equally by the Parties.

(d) Cooperation in Prosecution . Each Party shall provide the other Party all reasonable assistance and cooperation in the Patent prosecution efforts provided above in this Section 9.4, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.

9.5 Infringement of Patents by Third Parties .

(a) Notification . Each Party shall promptly notify the other Party in writing of any existing or threatened infringement of the KaloBios Patents and/or Sanofi Patents through the Development or Commercialization of a Licensed Product in the Territory by a Third Party, of which such Party becomes aware, including any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions (collectively, “ Product Infringement ”).

(b) Product Infringement

(i) For any Product Infringement in the Sanofi Field, each Party shall share with the other Party all Confidential Information available to it regarding such alleged infringement. Sanofi shall have the first right, but not the obligation, to bring at its own cost and expense an appropriate suit or other action against any person or entity engaged in such Product Infringement in the Sanofi Field, subject to Section 9.5(b)(iii) through 9.5(b)(iv) below. If Sanofi fails to institute and prosecute an action or proceeding to abate the Product Infringement in the Sanofi Field within a period of ninety (90) days after the first notice under 9.5(a) to elect to enforce such Sanofi Patent and/or KaloBios Patent or otherwise having knowledge of the Product Infringement in the Sanofi Field, then KaloBios shall have the right, but not the obligation, to commence a suit or take action to enforce the applicable Sanofi Patent and/or KaloBios Patent against such Third Party perpetrating such Product Infringement in the Sanofi Field in the Territory at its own cost and expense. In this case, Sanofi shall take appropriate actions in order to enable KaloBios to commence a suit or take the actions set forth in the preceding sentence.

(ii) For any Product Infringement in the KaloBios Field, each Party shall share with the other Party all Confidential Information available to it regarding such alleged infringement. KaloBios shall have the first right, but not the obligation, to bring at its own cost and expense an appropriate suit or other action against any person or entity engaged in such Product Infringement in the KaloBios Field, subject to Section 9.5(b)(iii) through 9.5(b)(iv) below. If KaloBios fails to institute and prosecute an action or proceeding to abate the Product Infringement in the KaloBios Field within a period of ninety (90) days after the first notice under 9.5(a) to elect to enforce such Sanofi Patent and/or KaloBios Patent or otherwise having knowledge of the Product Infringement in the KaloBios Field, then Sanofi shall have the right, but not the obligation, to commence a suit or take action to enforce the applicable Sanofi Patent

 

Page 44 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


and/or KaloBios Patent against such Third Party perpetrating such Product Infringement in the KaloBios Field in the Territory at its own cost and expense. In this case, KaloBios shall take appropriate actions in order to enable Sanofi to commence a suit or take the actions set forth in the preceding sentence.

(iii) Each Party shall provide to the Party enforcing any such rights under this Section 9.5(b) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by applicable Law to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts.

(iv) The Party not bringing an action with respect to Product Infringement under this Section 9.5(b) shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Party bringing such action.

(v) Sanofi’s rights under this Section 9.5(b) with respect to any KaloBios Patent licensed to KaloBios by a Third Party shall be subject to the rights of such Third Party to enforce such KaloBios Patent and/or defend against any claims that such KaloBios Patent is invalid or unenforceable.

(vi) KaloBios’ rights under this Section 9.5(b) with respect to any Sanofi Patent licensed to Sanofi by a Third Party shall be subject to the rights of such Third Party to enforce such Sanofi Patent and/or defend against any claims that such Sanofi Patent is invalid or unenforceable.

(c) Settlement .

(i) Sanofi shall not settle any claim, suit or action that it brought under this Section 9.5 involving KaloBios Patents in any manner that would negatively impact such KaloBios Patents or that would limit or restrict the ability of KaloBios to develop, make, import, use, offer for sale, sell or otherwise commercialize any product Controlled by KaloBios as of the Effective Date or during the Term without the prior written consent of KaloBios, which consent shall not be unreasonably withheld or delayed. Nothing in this Article 9 shall require KaloBios to consent to any settlement that is reasonably anticipated by KaloBios to have a substantially adverse impact upon any KaloBios Patent.

(ii) KaloBios shall not settle any claim, suit or action that it brought under this Section 9.5 involving Sanofi Patents in any manner that would negatively impact such Sanofi Patents or that would limit or restrict the ability of Sanofi to develop, make, import, use, offer for sale, sell or otherwise commercialize any product Controlled by Sanofi as of the Effective Date or during the Term without the prior written consent of Sanofi, which consent shall not be unreasonably withheld or delayed. Nothing in this Article 9 shall require Sanofi to consent to any settlement that is reasonably anticipated by Sanofi to have a substantially adverse impact upon any Sanofi Patent.

 

Page 45 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(iii) Allocation of Proceeds . If either Party recovers monetary damages from any Third Party in a suit or action brought for a Product Infringement, such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel), and any remaining amounts shall be retained by the Party bringing suit, provided that, in the event Sanofi is the Party bringing suit, such remaining amounts shall be included in the Net Sales and shall be subject to the royalty obligation set forth in Section 8.3 [***].

9.6 Infringement of Third Party Rights . Subject to Article 11, if any Product becomes the subject of a Third Party’s claim or assertion of Patent infringement, the Party first having notice of the claim or assertion shall promptly notify the other Party, the Parties shall agree on and enter into an “common interest agreement” wherein such Parties agree to their shared, mutual interest in the outcome of such potential dispute, and thereafter, the Parties shall promptly meet to consider the claim or assertion and the appropriate course of action.

9.7 Patent Term Extensions . Each Party shall inform the other Party of any supplementary protection certificate or patent term extensions or periods of data exclusivity, as the case may be, and more generally the Parties shall diligently cooperate with respect to any procedures for patent and period of data exclusivity extensions, such as but not limited to supplementary protection certificates, patent term extensions and corresponding GATT regulations. The Parties shall mutually agree on all such filings, not to be unreasonably withheld or delayed.

9.8 Scope of this Agreement .

(a) Except to the extent either Party is restricted by the licenses granted to the other Party herein (i.e. Sections 2.1 and 2.2 and the limitations on those grants pursuant to Section 2.7), each Party shall be entitled to practice, exploit and grant licenses with respect to the Joint Inventions without the duty of accounting or obtaining consent from the other Party.

(b) Except as expressly provided in this Agreement, under no circumstances will a Party hereto, as a result of this Agreement, obtain any ownership interest in, or any other right or license (directly or by implication) to, any Confidential Information, Patents, Know-How or Materials of the other Party existing as of the Effective Date. Furthermore, except as expressly provided herein, the Parties hereto each acknowledge and agree that any Confidential Information, Patents, Know-How or Materials discovered, developed, or acquired by or on behalf of either Party independent of such Party’s performance of its obligations under this Agreement (e.g. under the Sanofi Development Plan or KaloBios Development Plan) will be the exclusive property of such Party.

9.9 Trademarks .

(a) Sanofi shall be primarily responsible for the selection, registration, maintenance and defense of all Marks for use in connection with the sale or marketing of a Licensed Product in the Sanofi Field in the Territory. Sanofi shall own such Marks and shall grant KaloBios a license with respect thereto to conduct its obligations pursuant to the KaloBios Commercialization Plan. Sanofi shall be responsible for all costs for such Marks. All uses of such Marks shall be reviewed by the JSC and shall comply with all applicable Laws and regulations (including those Laws and regulations particularly applying to the proper use and designation of trademarks in the applicable countries).

 

Page 46 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(b) KaloBios shall be primarily responsible for the selection, registration, maintenance and defense of all Marks for use in connection with the sale or marketing of a Licensed Product in the KaloBios Field in the Territory. KaloBios shall be responsible for all costs for such Marks. All uses of such Marks shall be reviewed by the JSC and shall comply with all applicable Laws and regulations (including those Laws and regulations particularly applying to the proper use and designation of trademarks in the applicable countries).

(c) Neither Party shall, without the other Party’s prior written consent, use any Mark or Marks that include, in whole or part, any corporate name or logo of the other Party, or marks confusingly similar thereto, in connection with such Party’s marketing or promotion of Products under this Agreement except as provided in Section 6.5 or to the extent required to comply with applicable Laws and regulations.

ARTICLE 10

REPRESENTATIONS AND WARRANTIES

10.1 Mutual Representations and Warranties . Each Party hereby represents, warrants, and covenants (as applicable) to the other Party as follows:

(a) Corporate Existence and Power . It is a company or corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.

(b) Authority and Binding Agreement . As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and (iii) the 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.

(c) No Conflict; Covenant . It is not a party to any agreement that would materially prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under the Agreement.

(d) No Debarment . In the course of the development of Licensed Products, each Party shall not use, during the Term, any employee or consultant who has been debarred by any Regulatory Authority, or, to the best of such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority.

 

Page 47 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


10.2 Additional Representations and Warranties of KaloBios . KaloBios represents and warrants to Sanofi that, as of the Effective Date:

(a) it has the right under the KaloBios Technology to grant the licenses to Sanofi as purported to be granted pursuant to this Agreement;

(b) KaloBios has not received as of the Effective Date any written notice form any Third Party asserting or alleging that any research or Development of any Licensed Product by KaloBios prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party; and

(c) there are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations involving any Licensed Product and/or the KaloBios Technology relating to the Licensed Product by or against KaloBios or any of its Affiliates in or before any court, governmental or regulatory authority.

10.3 Disclaimer . Sanofi understands that the Licensed Products are the subject of ongoing clinical research and development and that KaloBios cannot assure the safety or usefulness of Licensed Products. In addition, KaloBios makes no warranties except as set forth in this Article 10 concerning the KaloBios Technology.

10.4 No Other Representations or Warranties . EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 10, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

ARTICLE 11

INDEMNIFICATION

11.1 Indemnification by KaloBios . KaloBios hereby agrees to defend, hold harmless and indemnify Sanofi and its Affiliates, agents, directors, officers and employees (the “ Sanofi Indemnitees ”) from and against any and all liabilities, expenses and/or losses, including reasonable legal expenses and attorneys’ fees (collectively “ Losses ”) in each case resulting from Third Party suits, claims, actions and demands (each, a “ Third Party Claim ”) arising directly or indirectly out of (a) a material breach of any of KaloBios’ obligations under this Agreement, including KaloBios’ representations and warranties or covenants set forth in Article 10, (b) the research, Development, manufacture, use, handling, storage, supply, sale, disposition or Promotion of Licensed Products in the KaloBios Field conducted by KaloBios or its Affiliates, or sublicensees, or by Sanofi in accordance with the KaloBios Development Plan or the instruction of KaloBios; or (c) the negligence or willful misconduct of any KaloBios Indemnitee. KaloBios’ obligation to indemnify the Sanofi Indemnitees pursuant to this Section 11.1 shall not apply to the extent that any such Losses arise from: (A) the negligence or willful misconduct of any Sanofi Indemnitee; (B) the research, Development or Commercialization of Licensed Products by Sanofi or its Affiliates, or sublicensees; or (C) Sanofi’s material breach of this Agreement.

 

Page 48 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


11.2 Indemnification by Sanofi . Sanofi hereby agrees to indemnify KaloBios and its Affiliates, agents, directors, officers and employees (the “ KaloBios Indemnitees ”) from and against any and all Losses resulting from Third Party Claims arising directly or indirectly out of (a) a material breach of any obligations of Sanofi under this Agreement, including Sanofi’s representations and warranties or covenants set forth in Article 10; (b) the research, Development, manufacture, use, handling, storage, supply, sale, disposition or Commercialization of Licensed Products in the Sanofi Field conducted by Sanofi or its Affiliates, or sublicensees, or by KaloBios in accordance with the Sanofi Development Plan or the instruction of Sanofi; or (c) the negligence or willful misconduct of Sanofi Indemnitees. Sanofi’s obligation to Indemnify the KaloBios Indemnitees pursuant to the foregoing sentence shall not apply to the extent that any such Losses arise from: (A) the negligence or willful misconduct of any KaloBios Indemnitee; or (B) KaloBios’ material breach of this Agreement.

11.3 Procedure . The indemnified Party shall provide the indemnifying Party with prompt notice of the claim giving rise to the indemnification obligation pursuant to this Article 11 and the exclusive ability to defend (with the reasonable cooperation of the indemnified Party) or settle any such claim; provided , however , that the indemnifying Party shall not enter into any settlement for damages other than monetary damages without the indemnified Party’s written consent, such consent not to be unreasonably withheld. The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party. If the Parties cannot agree as to the application of Sections 11.1 and 11.2 to any particular Third Party Claim, the Parties may conduct separate defenses of such Third Party Claim. Each Party reserves the right to claim indemnity from the other in accordance with Sections 11.1 and 11.2 above upon resolution of the underlying claim, notwithstanding the provisions of this Section 11.3 requiring the indemnified Party to tender to the indemnifying Party the exclusive ability to defend such claim or suit.

11.4 Limitation of Liability . NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR LOSS OF PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 12 OR EXCLUSIVITY OBLIGATIONS IN SECTION 2.7.

11.5 Insurance . Each Party shall procure and maintain policies of insurance or self-insurance, for general liability, product liability and clinical trials liability with minimum limits of $10,000,000 per occurrence and in aggregate, with carriers reasonably acceptable to the other Party. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 11. Each Party shall provide the other Party with written evidence of such insurance or self-insurance upon request, and shall include the other Party as an additional insured on such insurance policies as their interests may appear. Each Party shall provide the other Party with written notice at least thirty (30) days prior to the cancellation or non-renewal of such insurance or self-insurance which materially adversely affects the rights of the other Party hereunder.

 

Page 49 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 12

CONFIDENTIALITY

12.1 Confidentiality . Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, for the Term and for a period of five (5) years thereafter (except with regard to any Confidential Information which is a trade secret of either Party, in which case, the receiving Party’s obligation to hold such information in confidence shall be of indefinite duration), it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information furnished to it by the other Party pursuant to this Agreement except for that portion of such information or materials that the receiving Party can demonstrate by competent written proof:

(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other 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) is subsequently disclosed to the receiving Party or its Affiliate by a Third Party who has a legal right to make such disclosure; or

(e) is subsequently independently discovered or developed by the receiving Party or its Affiliate without the aid, application, or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.

12.2 Authorized Disclosure . Notwithstanding the obligations set forth in Section 12.1, a Party may disclose the other Party’s Confidential Information and the terms of this Agreement to the extent:

(a) such disclosure: (i) is reasonably necessary for the filing or prosecuting Patent rights as contemplated by this Agreement; or (ii) is reasonably necessary for the prosecuting or defending litigation as contemplated by this Agreement; or

(b) such disclosure is reasonably necessary: (i) to such Party’s directors, attorneys, independent accountants or financial advisors for the sole purpose of enabling such directors, attorneys, independent accountants or financial advisors to provide advice to the receiving Party, provided that in each such case on the condition that such directors, attorneys,

 

Page 50 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


independent accountants and financial advisors are bound by confidentiality and non-use obligations consistent with those contained in this Agreement; or (ii) to actual or potential investors and/or acquirers solely for the purpose of evaluating an actual or potential investment or acquisition; provided that in each such case on the condition that such actual or potential investors and/or acquirers are bound by confidentiality and non-use obligations consistent with those contained in the Agreement and having a minimum duration of at least five (5) years; or

(c) such disclosure is required by Law or judicial or administrative process, provided that in such event such Party shall promptly inform the other Party such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed as required by Law or judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 12, and the Party disclosing Confidential Information pursuant to Law or court order shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order to ensure the continued confidential treatment of such Confidential Information.

12.3 Publicity; Terms of Agreement .

(a) The Parties agree that the terms of this Agreement are the Confidential Information of both Parties, subject to the special authorized disclosure provisions set forth in Section 12.2 and this Section 12.3. If either Party desires to make a public announcement or news release concerning this Agreement, such Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein). The Parties agree that the public announcement of the execution of this Agreement will be made by a joint press release immediately following such execution. In the case of a public disclosure required by Law, the disclosing Party shall provide the other Party with a reasonable time to review and comment on such proposed disclosure, and in any event the reviewing Party shall not unreasonably withheld its approval of such proposed disclosure. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement that have already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 12.3.

(b) The Parties acknowledge that either or both Parties may be obligated to file a copy of this Agreement with the SEC or other Government Authorities, including but not limited to tax authorities. Each Party shall be entitled to make such a required filing, provided that it requests confidential treatment of at least the commercial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party. In the event of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which such Party intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with the legal requirements governing redaction of information from material agreements that must be publicly filed.

12.4 Publication . Each Party shall deliver to the other Party for review and comment a copy of any proposed publication or presentation that reports the results arising from the research or Development of a Licensed Product in the Territory. The other Party shall have the right to

 

Page 51 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


require modifications of the publication or presentation: (a) to protect such other Party’s Confidential Information; (b) for trade secret reasons or business reasons; and/or (c) to delay such submission for an additional ninety (90) days as may be reasonably necessary to seek patent protection for the information disclosed in such proposed submission.

ARTICLE 13

TERM AND TERMINATION

13.1 Term . This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 13, shall remain in effect until the date on which neither Party has, nor will have, any additional payment obligations to the other Party under this Agreement (the “ Term ”). Upon the expiration of the Royalty Term for a particular Licensed Product in a particular country, the license granted to Sanofi under the KaloBios Technology for such Licensed Product in such country shall become fully-paid and royalty-free for such Licensed Product.

13.2 Termination for Breach .

(a) Notice . If either Party believes that the other is in material breach of this Agreement, then the Party holding such belief (the “ Non-breaching Party ”) may deliver notice of such breach to the other Party (the “ Notified Party ”). The Notified Party shall have sixty (60) days to cure such breach to the extent involving non-payment of amounts due hereunder, and ninety (90) days to cure such breach for all other material breaches; provided that if a material breach (other than for non-payment) cannot reasonably be cured within the stated period and the breaching Party promptly delivers a plan to cure such breach (reasonably acceptable to the Non-Breaching Party) and uses Commercially Reasonable Efforts to cure such breach in accordance with such plan, then ninety (90) day cure period will be extended for so long as the breaching Party is using Commercially Reasonable Efforts to cure such breach (up to a maximum cure period of one hundred eighty (180) days from the date of initial notice).

(b) Scope of Termination . If the Notified Party fails to cure a material breach of this Agreement as provided for in Section 13.2(a), then the Non-Breaching Party may terminate this Agreement upon written notice to the Notified Party as follows: (i) the Non-Breaching Party shall have the right to terminate this Agreement (in all applicable territories) for the field to which the breach relates (either the Sanofi Field or KaloBios Field, as applicable); or (ii) may terminate this Agreement in its entirety in the event that the breach is material to this Agreement as a whole or to more than one field.

(c) Termination of Sublicense . For the sake of clarity, in the event KaloBios materially breaches its diligence obligation in Section 4.6(b), Sanofi shall have the right to terminate the rights and licenses granted under this Agreement to KaloBios for the Licensed Product in the KaloBios Field, that is, to terminate the sub-license granted to KaloBios pursuant to Section 2.2(a) hereof. For clarity, this Section 13.2(c) shall apply irrespective of whether Sanofi exercises its Option under Section 4.9.

 

Page 52 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(d) No Limit on Remedies . Nothing in this Section 13.2 shall be construed to limit either Party’s rights or remedies it may have in law, equity or otherwise, including a right to initiate a proceeding under Section 14.3.

(e) Consequences in the Event of KaloBios Material Breach . In the event that KaloBios materially breaches this Agreement and such breach is not cured as provided for herein, then, in addition to any other rights and remedies that Sanofi may have in law, equity or otherwise, Sanofi may elect to either:

(i) terminate this Agreement and (1) the consequences set out in Section 13.4(a), (c) and (d) shall apply, (2) Sanofi shall have an obligation to negotiate in good faith a license on such commercial terms as the Parties may reasonably agree to under Sanofi Technology to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize Licensed Products; and (3) Sanofi shall sell its inventory of Licensed Products to KaloBios at cost plus [***]; or

(ii) be entitled to deduct or otherwise offset any damage awarded under a proceeding initiated under Section 14.3 (or to which KaloBios agrees) against future milestone and/or royalty and/or other payments of that might otherwise be payable under this Agreement. In the event that no future amounts are due and payable by Sanofi, then KaloBios shall be obligated to pay from immediately available funds the amount of damages awarded by the arbitrators under the terms of Section 14.3 in accordance with the terms of such damage award. Sanofi shall be in breach of its payment obligations pursuant to Article 8, if it withholds payment of any monies that are not subject to any dispute under such proceeding, provided Sanofi may withhold payment of any monies that are subject to any dispute under such proceeding until such time as any arbitral award regarding damages owed to Sanofi for KaloBios’ breach is final and binding upon the Parties.

(f) Consequences in the Event of Sanofi Material Breach . In the event that Sanofi materially breaches this Agreement and such breach is not cured as provided for herein, then in addition to any other rights and remedies that KaloBios may have in law, equity or otherwise, KaloBios may initiate proceedings under Section 14.3 and Sanofi shall elect to either (i) accept and pay any damages awarded to KaloBios under such proceeding by the arbitrator, through an increase of future milestone and/or royalty and/or other payments payable under this Agreement as may be specified in such award, or (ii) be terminated by KaloBios and the provisions of Section 13.4 will apply.

13.3 Termination at Will . Sanofi shall have the right to terminate this Agreement in its entirety for any reason or no reason at all by providing KaloBios with [***] prior written notice to KaloBios of such termination. KaloBios shall have the right to terminate its license under Section 2 and its Development and Promotion rights to the License Product in the KaloBios Field for any reason or no reason at all by providing Sanofi with [***] days prior written notice to Sanofi of such termination. In the event of any such termination that is effective prior to Sanofi having not exercised its Option under Section 4.9, or KaloBios having not exercised its rights under Section 4.10 [***], then Sanofi shall not have diligence obligations with respect to the KaloBios Field.

 

Page 53 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


13.4 Consequences of Termination By Sanofi . Upon any termination of this Agreement by Sanofi under Section 13.3, Section 13.5 and (as provided in Section 13.2(f) or Section 13.6(a)(i)), the following shall apply (in addition to any other rights and obligations otherwise under this Agreement with respect to such termination) with respect to the applicable terminated field(s):

(a) Regulatory Filings; Data . Sanofi shall transfer and assign to KaloBios all Regulatory Filings, Regulatory Approvals, and related preclinical, analytical, and clinical data and all Materials generated by or on behalf of Sanofi, its Affiliates (or its sublicensees) for the Licensed Products throughout the Territory (each of which shall thereafter be deemed the Confidential Information of KaloBios).

(b) Manufacturing Process . Sanofi shall transfer the manufacturing process for the Licensed Products to KaloBios or its designee (which will be designated as soon as reasonably practical but in no event later than [***].

(c) Third Party Agreements . Sanofi shall, at the request of KaloBios, assign to KaloBios any or all agreements between Sanofi, its Affiliates and Third Parties, relating solely to the Development, manufacture or Commercialization of the Licensed Products, to the extent permissible under the terms of such agreements.

(d) Marks; Other Intellectual Property . Sanofi shall assign to KaloBios its and its Affiliates’ entire right, title and interest in and to any Marks relating solely to Licensed Products, including any registrations for the foregoing.

(e) Sanofi License . Sanofi hereby grants to KaloBios, effective only in the event of such termination, a [***] license under Sanofi Technology (which, for the purposes of this Section 13.4 does not include any rights licensed from KaloBios hereunder) to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize Licensed Products in the Sanofi Field or in the KaloBios Field, as the case may be, in the Territory. Promptly following any notice of termination under this Agreement, the Parties shall in good faith negotiate the financial terms of the foregoing license for a period of up to [***]. In the event that the Parties are unable to agree on such terms, then such matter shall be referred and finally settled through the procedures described in Section 14.3, requiring the arbitrators to render a final and binding decision [***]. The Parties agree and acknowledge that the terms of such license shall be commercially reasonable and shall include payment of any amounts owned to Third Parties in respect of the Development or Commercialization of the Licensed Products by KaloBios. If the Parties fail to reach an agreement on the terms and conditions of the license or a binding decision is not rendered prior to the effective date of termination, then Sanofi covenants during the pendency of such negotiation or proceeding not to sue KaloBios, its Affiliates or any third party sublicensee under any Sanofi Technology in connection with any research, development, manufacture, use sale, import, export or other commercialization of a Licensed Product.

(f) Interim Supply . At KaloBios’ request, Sanofi shall supply, or cause to be supplied, to KaloBios sufficient quantities of Licensed Products to satisfy KaloBios” and its Affiliates’ and sublicensees’ requirements for Licensed Product for a period of the earlier of (i)

 

Page 54 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


when KaloBios is able to manufacture or have manufacture Licensed Products itself or (ii) two (2) years following the effective date of termination; provided that KaloBios shall use Commercially Reasonable Efforts to affect such assumption (or transition) as promptly as practicable. Such supply shall be at a price equal to [***] for such Licensed Product(s). Any such supply will be made pursuant to a supply agreement between the Parties with typical provisions relating to quality, forecasting and ordering to forecast, force majeure and product liability and indemnity. In the event that Sanofi has one or more agreements with Third Party manufacturers with respect to the manufacture of a Licensed Product, at KaloBios” request, Sanofi shall use Commercially Reasonable Efforts to transfer its rights and obligations under such agreement(s) to KaloBios upon any such termination.

(g) Transition Assistance . Sanofi shall provide such assistance, at no cost to KaloBios, as may be reasonably necessary or useful for KaloBios to commence or continue Developing or Commercializing Licensed Products in the Sanofi Field in the Territory, to the extent Sanofi is then performing or having performed such activities, including transferring or amending as appropriate, upon request of KaloBios, any agreements or arrangements with Third Party vendors with respect to Licensed Products. To the extent that any such contract between Sanofi and a Third Party is not assignable to KaloBios, then Sanofi shall reasonably cooperate with KaloBios to arrange to continue to and provide such services from such entity. Assistance under this Section 13.4 shall be provided for not more than six (6) months following the effective date of termination. In addition, upon any termination of this Agreement under Section 13.3, the Party terminating this Agreement shall pay its share of all costs for which it was responsible during the pendency of any applicable notice period and any other uncancellable obligations payable to Third Parties.

(h) Confidential Information . Upon request, each Party shall return to the other copies of any Confidential Information of the other Party in such Party’s possession or control, except as required pursuant to this Section 13.4, and further provided that each Party shall be entitled to retain a copy of any such Confidential Information for purpose of ensuring compliance with its obligations herein, and further provided that neither Party shall be required to delete from any servers or other electronic archiving devices any Confidential Information from the other Party, but such information shall not be accessed after the end of the transition period referred to in Section 13.4(g) above.

13.5 Termination for Technical Failure . In the event that Sanofi wishes to terminate this Agreement due to a patient safety or other scientific reason (not for commercial reasons or otherwise caused by Sanofi) that makes the Licensed Product unreasonable to Develop or Commercialize in the Sanofi Field or the KaloBios Field (as the case may be at the time) using Commercially Reasonable Efforts, then Sanofi may terminate this Agreement on [***] written notice to KaloBios, and the consequences of termination set out in Section 13.4 shall apply, except that (a) the period during which Sanofi shall be required to provide an interim supply of Licensed Products under 13.4(f) shall be [***] and (b) the period for assistance under 13.4(g) shall be [***].

 

Page 55 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


13.6 Bankruptcy .

(a) In the event that KaloBios makes a general assignment for the benefit of creditors, is the subject of proceedings in voluntary or involuntary bankruptcy or has a receiver or trustee appointed for all or substantially all of its property, then Sanofi may either:

(i) terminate this Agreement forthwith and the consequences described in Section 13.4(a), (c) and (d) shall apply; provided that in the case of an involuntary bankruptcy proceeding, such right to terminate shall only become effective if KaloBios consents thereto or such proceeding is not dismissed within ninety (90) days after the filing thereof. In the event that Sanofi exercises its termination rights, then upon request, KaloBios, or any trustee or receiver or other agent appointed to manage the assets of KaloBios, shall deliver all of Sanofi’s Confidential Information in KaloBios’ possession or control within ninety (90) days of the effective date of termination.

(ii) continue this Agreement in full force and effect, and without prejudice to any other remedies that Sanofi may have at law, equity or otherwise, and require KaloBios, or any trustee or receiver or other agent appointed to manage the assets of KaloBios, to take all steps, execute all documents, and transfer to Sanofi, to the extent permitted by applicable law or any agreements with any Third Party, the KaloBios Technology applicable to the Ex-U.S. Countries licensed hereunder to the extent necessary for Sanofi to continue to practice rights and licenses in such countries pursuant to a third party escrow or other arrangement reasonably acceptable to KaloBios and Sanofi to be negotiated by the Parties as soon as practical following the Effective Date, subject in all cases to Sanofi’s continued performance under the terms of this Agreement. Furthermore, in the case of any proceeding described in subsection (a) above, KaloBios or any trustee or receiver or other agent appointed to manage the assets of KaloBios, shall reasonably cooperate with Sanofi to obtain from any Third Party a direct license to any technology sub-licensed to Sanofi hereunder.

(b) All rights and licenses granted under or pursuant to this Agreement by one Party to the other are, for all purposes of Section 365(n) of Title 11 of the United States Code (“ Title 11 ”), licenses of rights to “intellectual property” as defined in Title 11, and, in the event that a case under Title 11 is commenced by or against either Party (the “ Bankrupt Party ”), the other Party shall have all of the rights set forth in Section 365(n) of Title 11 to the maximum extent permitted thereby. During the Term, each Party shall create and maintain current copies to the extent practicable of all such intellectual property. Without limiting the Parties rights under Section 365(n) of Title 11, if a case under Title 11 is commenced by or against the Bankrupt Party, the other Party shall be entitled to a copy of any and all such intellectual property and all embodiments of such intellectual property, and the same, if not in the possession of such other Party, shall be promptly delivered to it (i) before this Agreement is rejected by or on behalf of the Bankrupt Party, within thirty (30) days after the other Party’s written request, unless the Bankrupt Party, or its trustee or receiver, elects within thirty (30) days to continue to perform all of its obligations under this Agreement, or (ii) after any rejection of this Agreement by or on behalf of the Bankrupt Party, if not previously delivered as provided under clause (i) above. All rights of the Parties under this Section 13.6(b) and under Section 365(n) of Title 11 are in addition to and not in substitution of any and all other rights, powers, and remedies that each Party may have under this Agreement, Title 11, and any other applicable Law. The Parties agree that they intend the foregoing non-Bankrupt Party rights to extend to the maximum extent permitted by law and any provisions of applicable contracts with Third Parties.

 

Page 56 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


13.7 Termination of Licenses . Upon any termination of this Agreement, all rights and licenses granted by a Party to the other Party (and any sublicensee thereof) hereunder will terminate, except as expressly provided in Section 13.9.

13.8 Accrued Rights . Termination of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to the effective date of such termination, including any amounts payable under this Agreement. Such termination will not relieve a Party from obligations that are expressly indicated to survive the termination of this Agreement.

13.9 Survival . The following provisions shall survive any expiration or termination of this Agreement for the period of time specified: Articles 1, (solely with respect to payments that are due as of the effective date of such expiration or termination), 11, 12, 14, and 15, and Sections 8.9, 8.10, 9.1, 9.2, 9.3, 10.3, 10.4, 13.2, 13.4, 13.6, 13.7-13.9.

ARTICLE 14

DISPUTE RESOLUTION

14.1 Disputes . The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation; provided that the Parties agree that any matters expressly delegated to the JSC for resolution shall follow the procedures in Article 3 and as may be amended by the Parties upon Sanofi’s exercise of the Option. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 14 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

14.2 Internal Resolution . With respect to all disputes arising between the Parties under this Agreement, including any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within thirty (30) days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Chief Executive Officers of the Parties or their respective delegate for attempted resolution by good faith negotiations within thirty (30) days after such notice is received.

14.3 Binding Arbitration . If the Chief Executive Officers of the Parties or their respective delegate are not able to resolve such disputed matter within thirty (30) days and either Party wishes to pursue the matter, each such dispute, controversy or claim that is not an Excluded Claim (as defined in Section 14.4 below) shall be finally resolved by binding arbitration administered by the International Chamber of Commerce pursuant to its rules and procedures then in effect (the “ ICC Rules ”), and judgment on the arbitration award may be entered in any court having jurisdiction thereof. Notwithstanding anything to the contrary in the ICC Rules, the Parties agree that:

 

Page 57 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


(a) The arbitration shall be conducted by a panel of three persons experienced in the pharmaceutical business: within thirty (30) days after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected arbitrators shall select a third arbitrator within thirty (30) days of their appointment. If the arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by the ICC. The place of arbitration shall be New York, New York, USA, and all proceedings and communications shall be in English.

(b) Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damage. Each Party shall be responsible for its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration.

(c) Except to the extent necessary to confirm an award or as may be required by law, neither a Party, nor an arbitrator, may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable statute of limitations.

14.4 As used in this Article 14, the term “ Excluded Claim ” shall mean a dispute, controversy or claim that concerns (a) the scope, validity, enforceability, inventorship or infringement of a Patent Mark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.

ARTICLE 15

MISCELLANEOUS

15.1 Entire Agreement; Amendment . This Agreement, including the Exhibits hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior agreements and understandings between the Parties with respect to the subject matter hereof. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

 

Page 58 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


15.2 Force Majeure . Each Party shall be excused from the performance of its obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall include conditions beyond the reasonable control of the nonperforming Party, including an act of God or terrorism, voluntary or involuntary compliance with any regulation, law or order of any government, war, civil commotion, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe. Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party. If a force majeure persists for more than ninety (90) days, then the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.

15.3 Notices . Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 15.3, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or sent by confirmed facsimile or a reputable courier service, or (b) five (5) business days after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested.

 

If to KaloBios:   

KaloBios Pharmaceuticals, Inc.

260 East Grand Avenue

South San Francisco, CA 94080

U.S.A.

  

Attn: Legal Department

Facsimile: 650-243-3261

If to Sanofi:   

Sanofi Pasteur S.A.

2, avenue Pont Pasteur

69007 Lyon, France

Attention: Vice President, Legal Affairs & General Counsel

   Facsimile: 011 33 4 37 37 70 61
  

Copy to: Sanofi Pasteur Limited

Attention: Legal Affairs

Facsimile: 1 416 667-2977

15.4 No Strict Construction; Headings; Interpretation . This Agreement has been prepared jointly and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. Except

 

Page 59 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


where the context otherwise requires, the use of any gender herein shall be deemed to be or include the other genders, the use of the singular shall be deemed to include the plural (and vice versa) and the word “or” is used in the inclusive sense (and/or). The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation.” The word “will” shall be construed to have the same meaning and effect as the word “shall.” Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (b) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (c) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof and (d) all references herein to Sections or Exhibits shall be construed to refer to Sections or Exhibits of this Agreement.

15.5 Assignment . Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party’s consent to an Affiliate of such Party or to a successor to substantially all of the business of such Party in connection with any Change in Control. Any permitted successor or assignee of rights and/or obligations hereunder shall, in writing to the other Party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 15.5 shall be null, void and of no legal effect.

15.6 Performance by Affiliates . Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

15.7 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

15.8 Severability . If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

15.9 No Waiver . Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

 

Page 60 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


15.10 Independent Contractors . Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

15.11 English Language; Governing Law . This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement. This Agreement and all disputes arising out of or related to this Agreement or any breach hereof shall be governed by and construed under the Laws of the State of New York, USA, without giving effect to any choice of law principles that would require the application of the Laws of a different jurisdiction.

15.12 Compliance . In carrying out its rights and obligations hereunder, each Party shall comply with all applicable Laws.

15.13 Counterparts . This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[SIGNATURE PAGE FOLLOWS]

 

Page 61 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


I N W ITNESS W HEREOF , the Parties have executed this Agreement in duplicate originals by their duly authorized officers.

 

S ANOFI P ASTUR S.A.     K ALO B IOS P HARMACEUTICALS , I NC .
By:   /s/ Wayne Pisano     By:   /s/ David Pritchard
Name:   Wayne PISANO     Name:   David Pritchard
Title:   President & Chief Executive Officer     Title:   Chief Executive Officer
Date:   January 22, 2010     Date:   January 8, 2010
By:   /s/ Dominique Carouge      
Name:   Dominique CAROUGE      
Title:   Chief Strategic & Finance Officer      
Date:   January 21, 2010      

 

Page 62 of 76

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBITS

 

Page 1 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT A

[***]

[***]

[***]

[***]

[***]

 

Page 2 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT B

[***]

[***]

[***]

[***]

[***]

 

Page 3 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT C

[***]

[***]

[***]

[***]

[***]

 

Page 4 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT D

 

[***]

   [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***] [ *** ]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]
[***]    [***]    [***]    [***]    [***]

 

Page 5 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT E-1

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

Page 6 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT E-2

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

Page 7 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT F

Exclusive License Agreement for Anti-PcrV Antibody between The Regents of the University of California and KaloBios, Inc. dated 6 April 2004.

 

Page 8 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


Exhibit G

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

         [***]

           [***]

         [***]

           [***]

         [***]

           [***]

[***]

[***]

        [***]

        [***]

        [***]

        [***]

 

Page 9 of 10

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


AMENDMENT NO. 1 TO

DEVELOPMENT, COMMERCIALIZATION

COLLABORATION AND LICENSE AGREEMENT

This Amendment No. 1 to the Development, Commercialization Collaboration and License Agreement dated January 8, 2010 (the “License Agreement”) between KaloBios Pharmaceuticals, Inc., a Delaware corporation, with its principal place of business at 260 East Grand Avenue, South San Francisco, California, U.S.A. 94080 (“KaloBios”), and Sanofi Pasteur S.A., a company organized and existing under the laws of the Republic of France, having offices located at 2, avenue Pont Pasteur, 69007 Lyon, France (“Sanofi”). KaloBios and Sanofi are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” Defined terms used herein and not defined shall have the meanings ascribed to them in the License Agreement.

RECITALS

W HEREAS , the Parties to the License Agreement wish to revise certain terms thereof relating to third party licenses.

Now Therefore, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Amendment, the Parties agree as follows.

1. Amendment . In accordance with Section 15.1 of the License Agreement, the Parties hereby agree to the following amendments:

(a) Existing Third Party Licenses . Section 8.4 of the License Agreement is hereby deleted in its entirety and replaced with the following:

“8.4 Existing Third Party Licenses. KaloBios will be responsible for all amounts owed to Third Parties after the Effective Date pursuant to Third Party Licenses entered into prior to the Effective Date; provided that the Parties shall [***] all royalty amounts due under that certain Exclusive License Agreement with the Regents of the University of California dated as of April 5, 2004. [***].”

(b) Future Third Party Licenses . Section 8.5 of the License Agreement is hereby deleted in its entirety and replaced with the following:

“Future Third Party Licenses. The Parties shall [***] all amounts owed to Third Parties after the Effective Date pursuant to any [***] or other Third Party agreed upon by the Parties, license or technology acquisition agreement under which a Party obtains rights to a Third Party patent or know-how that is necessary or useful for the Development, manufacture or Commercialization of Licensed Products. In the event that either Party identifies such intellectual property, it shall notify the other Party and the Parties shall promptly meet and designate one Party to obtain such license or otherwise acquire such necessary rights on commercially reasonable terms (such party the “ Lead Party ”). Prior to entering into such agreement, the Lead Party shall share with the other Party the terms of the applicable Third Party agreement and the consent of both Parties

 

Page 1 of 4

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


shall be required for the Lead Patty to enter into such agreement for the purpose of sharing the cost of such payments hereunder. Upon receipt of such consent, the Lead Party shall enter into such Third Party agreement and shall be responsible for making all payments to the applicable Third Party. The other Party shall reimburse the Lead Party for its [***] share of such payments within thirty (30) days of the end of the month following the receipt of an invoice for such payment. In the event that the other Party does not consent to the entry of a proposed Third Party agreement on terms proposed by the Lead Party within thirty (30) days following receipt of notice of the terms thereof, then the Lead Party shall have the right to enter into the proposed agreement with the Third Party, provided that the Parties agree that in such event the rights to any patent or know-how obtained under such Agreement by the Lead Party shall be excluded from any patent or know-how licensed to the other Party under this Agreement.

Notwithstanding the foregoing, and for greater certainty, the Parties agree that in respect of that license agreement between The Regents of the University of California and KaloBios dated October 4, 2011 concerning rights in a joint invention arising from a sponsored research agreement dated January 8, 2008 regarding a project entitled: “[***]” (the “2 nd UCSF License”), that Sanofi shall have no obligation to make any payment to KaloBios or the University of California for milestone payments (i.e. those set out in Article 9 thereof) for any “Licensed Products” (as that term is defined under that specific agreement) in the KaloBios Field in which Sanofi does not have commercial rights pursuant to this Agreement.”

2. Article 1 of the License Agreement is hereby amended by adding a new definition between definitions 1.27 and 1.28 as follows:

“1.27(A) “Filled Drug Product” shall mean Bulk Substance that has undergone the additional manufacturing steps of formulation and filling, but not labelling and packaging other than as required for delivery of unlabeled vials (i.e. not labeled and packaged for use in a clinical trial).”

1.27(B) “Finished Product” means any Licensed Product manufactured in accordance with the specifications agreed to by the Parties and cGMP, which has undergone all processing steps including the steps of formulation, filling and packaging necessary to administer such product through intra venous infusion.”

 

3. Article 7 of the License Agreement is hereby amended by adding a new Section immediately after Section 7.5.

“7.6 Manufacture of Filled Drug Product for establishing proof of concept in the KaloBios Field . Upon execution of suitable supply and quality agreements, Sanofi agrees to supply KaloBios with Filled Drug Product for use solely in Phase 1 Clinical Trials and Phase II Clinical Trials in the KaloBios Field. Sanofi shall have no responsibility to provide Finished Product to KaloBios for Commercialization by KaloBios in the KaloBios Field.”

 

4. Article 4 of the License is hereby amended by adding a new Section 4.5.1 as follows:

“4.5.1 In addition to the activities set out in Exhibit G, KaloBios agrees to perform, and Sanofi agrees to reimburse KaloBios, for those Development activities described on Exhibit H attached hereto, such activities to be conducted between [***], or such other period as may be agreed

 

Page 2 of 4

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


upon. Sanofi may terminate such activities if KaloBios no longer has the personnel or resources to carry them out to the satisfaction of Sanofi. Sanofi shall reimburse KaloBios for the costs of the activities in Exhibit H following their completion (including receipt of appropriate reports) in accordance with Section 8.9.”

5. Effective Date of this Amendment No. l . The Parties agree that the amendments set forth in this Amendment No l shall be effective as from [***].

6. Confirmation . The Parties otherwise confirm all other terms and provisions of the License Agreement.

7. Counterparts . This Amendment No. I made he executed in two counterparts, each of which is an original, and which, taken together, shall form one instrument.

I N W ITNESS W HEREOF , the Parties have executed this Agreement in duplicate originals by their duly authorized officers.

 

Sanofi Pasteur S.A.     KaloBios Pharmaceuticals, Inc.
By:         By:    
Name:       Name:   David Prichard
title:       Title:   Chief Executive Officer
Date:         Date:    

 

Page 3 of 4

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


Exhibit H

 

Page 4 of 4

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT H

 

[***]

           

1.      [***]

           

a.      [***]

           

b       [***]

           

c.      [***]

   [***]    [***]            [***]            [***]        

i.                 [***]

   [***]   

[***]

  

[***]

  

[***]

ii.      [***]

   [***]   

[***]

  

[***]

  

[***]

iii.    [***]

   [***]   

[***]

  

[***]

  

[***]

            [***]

2.      [***]

           

a.      [***]

           

b.      [***]

           

c.      [***]

           

d.      [***]:

   [***]    [***]            [***]            [***]        

i.       [***]

   [***]    [***]    [***]    [***]

ii.      [***]

   [***]    [***]    [***]    [***]
            [***]

3.      [***]

           
   [***]    [***]            [***]            [***]        

i.       [***]

   [***]    [***]    [***]    [***]

4,      [***]

           

[***]

           
   [***]    [***]            [***]            [***]        

i.       [***]

   [***]    [***]    [***]    [***]

ii.      [***]

   [***]    [***]    [***]    [***]

iii.     [***]

   [***]    [***]    [***]    [***]
            [***]

[***]

           

[***]

           

[***]

           

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION

Exhibit 10.16

NON-EXCLUSIVE LICENSE AGREEMENT

THIS NON-EXCLUSIVE LICENSE AGREEMENT (the “Agreement”), effective as of October 15, 2010 (the “Effective Date”), is entered into by and between BioWa, Inc. , a Delaware corporation, with a principal place of business at 212 Carnegie Center, Suite 101, Princeton, New Jersey 08540, USA (“BioWa”), Lonza Sales AG, a Swiss corporation, with a principal place of business at Munchensteinerstrasse 38, Basel, CH-4002 Switzerland (“Lonza) (together “the Licensor”) and Kalobios Pharmaceuticals, Inc. , of 260 E. Grand Ave., South San Francisco, CA 94080, USA (“Licensee”). Lonza, BioWa, Licensor or Licensee may hereafter be referred to individually as a “Party” and collectively as the “Parties.”

BACKGROUND

WHEREAS, BioWa and Licensee entered into a Non-Exclusive License Agreement, effective as of September 2, 2008, whereby BioWa granted to Licensee a license for the use of certain technology owned or controlled by BioWa (“Potelligent ® Technology”) in the development of products (“2008 License”); and

WHEREAS , BioWa, Lonza and Licensee entered into a letter agreement dated as of December 11, 2008 (“2008 Letter Agreement”), whereby Lonza received a limited license to the Potelligent ® Technology to perform certain services for Licensee and Licensee paid to BioWa the Access Fee (as defined therein) in connection therewith; and

WHEREAS, Lonza and Licensee entered into a Research Evaluation Agreement dated as of May 6, 2008 (“Lonza License”), whereby Licensee received a limited non-exclusive license to Lonza’s GS System (as defined in the Lonza License) and Transfection Medium System (as defined in the Lonza License) for research purposes; and

WHEREAS , Lonza and BioWa have combined Lonza’s GS System and BioWa’s Potelligent ® Technology and their related intellectual property to jointly create Potelligent ® CHOK1SV for use in combination with the Vectors (all as herein defined, and referred to as the “Technology,” as more fully defined in Section 1.62); and

WHEREAS , Licensee wishes to acquire certain nonexclusive rights to the Technology to research and develop monoclonal antibodies capable of specifically binding to targets which shall be identified and mutually agreed upon as specified in this Agreement; and

WHEREAS , Licensor is willing to grant such license to the Technology and the Licensee desires to take such license, subject to the terms and conditions in this Agreement.

NOW, THEREFORE , in consideration of the mutual covenants and agreements contained herein, the Parties, intending to be legally bound, agree as follows:

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 1

DEFINITIONS

Words or phrases having their initial letter capitalized shall, except as clearly provided otherwise in this Agreement or in the context in which they are used, have the respective meanings set forth below. A cross-reference below to a defined term in this Agreement is for the convenience of the reader of this document, and this Article 1 may not contain an exhaustive list of all words or phrases defined elsewhere in this Agreement.

1.1 “Activities” means the Research, development, manufacturing and commercialization activities performed by Licensee and any permitted Sublicensee under this Agreement.

1.2 “ADCC” means Antibody Dependent Cellular Cytotoxicity.

1.3 “Affiliate” means any corporation, company, partnership, joint venture, firm or other business entity which controls, is controlled by, or is under common control with a Party. For purposes of this definition, “control” shall be presumed to exist if one of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entities.

1.4 “Antibody” means a monoclonal antibody, antibody fragment or any composition of matter derived therefrom, made through use of the Technology [***]. For purposes of this Agreement, “derived” shall mean obtained, developed, created, synthesized, designed, derived or resulting from, based upon or otherwise generated (whether directly or indirectly, or in whole or in part). For purpose of clarity, the foregoing shall include any monoclonal antibody, any CDR (complementarity determining region), variable or constant region, any single chain antibody, any partially or fully humanized antibody, any peptides identified through antibody phage display, and any peptide derived from one or more antibodies based on the sequence and structure information of the antibodies, e.g. binding site information of the antibodies.

1.5 “Approval” means , with respect to a Product in a particular jurisdiction, the technical, medical and scientific licenses, registrations, authorizations and approvals (including, without limitation, approval of a BLA, and pricing and Third Party reimbursement approvals, and labeling approvals with respect thereto) of any national, supra-national, regional, state or local regulatory agency, necessary for the commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of a Product.

1.6 “Bankruptcy Code” means Title 11 of the United States Code.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.7 “Biologics License Application” or “BLA” means a Biologics License Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. Section 600 et seq., for FDA approval of a Product and “sBLA” means a supplemental BLA, and any equivalent or a New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, and any corresponding non-U.S. marketing authorization application, registration or certification, necessary to market a Product in any country outside the U.S., but not including applications for pricing and reimbursement approvals.

1.8 “BioWa Research License Fee” has the meaning set forth in Section 6.2.1.

1.9 “BioWa Royalties” has the meaning set forth in Section 6.5.1.

1.10 “Blank Rome LLP” means the law firm of Blank Rome LLP, a limited liability partnership having a principal place of business at One Logan Square, 130 North 18 th Street, Philadelphia, PA 19103.

1.11 “Business Day” means any day that is not a Saturday, Sunday or other day on which commercial banks in New York, New York, United States are required or authorized by law to be closed.

1.12 “Calendar Quarter” means each three-month period commencing on January 1, April 1, July 1 or October 1 of each year during the Term.

1.13 “CHOK1SV Cell Line” means Lonza’s suspension variant host Chinese Hamster Ovary (CHO) cell line.

1.14 “Claims” has the meaning set forth in Section 11.1.

1.15 “Commencement” means, with respect to a Phase I, Phase II or Phase III Clinical Trial, the date upon which the first patient is dosed in such Clinical Trial.

1.16 “Commercial License” has the meaning set forth in Section 2.1.2.

1.17 “Commercial License Fee” has the meaning set forth in Section 6.3.

1.18 “Commercial License Notification” has the meaning set forth in Section 2.2.

1.19 “Commercial Target” means a Research Target that has been confirmed as available by the Third Party Reviewer under Section 4.3.3 and for which Licensee has requested a Commercial License under Section 2.2. For purposes of clarity, Licensee shall be entitled to designate [***] Commercial Targets in total between this Agreement and the 2008 License.

1.20 “Competing Contract Manufacturer” means any Third Party who undertakes or performs more than fifty percent (50%) of their business as a manufacturer of monoclonal antibodies and/or therapeutic proteins or any product of a similar nature to that to which this Agreement relates.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.21 “Confidential Information” means all confidential or other proprietary information of a Party that is provided to another Party, whether written, oral or otherwise, and including, but not limited to, Know-How or other information, whether or not patentable, regarding a Party’s technology, products, business information or objectives that is designated as confidential, or which under the circumstances surrounding disclosure or given the nature of the information would reasonably be believed to be confidential. Notwithstanding anything to the contrary, Progress Reports shall be deemed to be Confidential Information of Licensee.

1.22 “Control” or “Controlled” means, with respect to a Know-How or Patent right, that a Party has the ability to grant a license or a sublicense to such intellectual property without violating the terms of any agreement with a Third Party.

1.23 “Effective Date” has the meaning set forth in the preamble to this Agreement.

1.24 “Enforcement Action” has the meaning set forth in Section 8.3.

1.25 “FDA” means the U.S. Food and Drug Administration and any successors thereto and its foreign counterparts throughout the world.

1.26 [***]

1.27 “Field” means the prevention , diagnosis and treatment of human diseases.

1.28 “First Commercial Sale” means, with respect to any Product, the first bona fide commercial sale by Licensee or its Sublicensee of such Product following an Approval in any country.

1.29 “GS System” means Lonza’s glutamine synthetase gene expression system consisting of the CHOK1SV Cell Line, the Transfection Supplements System, the Vectors, and the related Know-How and Patents Controlled by Lonza, whether used individually, or in combination with each other. For the avoidance of doubt, any gene proprietary to Licensee inserted into the GS System for the purposes of producing Product does not form part of the GS System.

1.30 “Improvements” means any inventions or other intellectual property (including all Patent, Know-How and other intellectual property rights therein) made by or under authority of the Licensee during the Term in conducting the Activities contemplated by this Agreement.

1.31 “IND” means an Investigational New Drug application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, or any corresponding non-U.S. application, registration or certification necessary to transport or distribute investigational new drugs for clinical testing in any country outside the U.S.

1.32 “Indemnitee” and “Indemnitor” have the respective meanings set forth in Section 11.3.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.33 “IP” means intellectual property.

1.34 “Know-How” means any proprietary technical or other information whether patentable or not and whether in written or verbal form, which is confidential and may include technology, experience, formulae, concepts, discoveries, trade secrets, inventions, modifications, improvements, data (including all chemical, preclinical, pharmacological, clinical, pharmacokinetic, toxicological, analytical and quality control data), results, designs, ideas, analyses, methods, techniques, assays, research plans, procedures, tests, processes (including manufacturing processes, specifications and techniques), laboratory records, reports, summaries, and information contained in submissions to, and information from, regulatory authorities.

1.35 “Licensor IP Rights” means the Licensor Know-How and the Licensor Patent Rights.

1.36 “Licensor Know-How” means Know-How owned or Controlled by Licensor that relates directly to the Technology and is provided to Licensee hereunder.

1.37 “Licensor Patent Rights” means the Patents set out in Exhibit 1 hereto, solely to the extent that such Patents relate to the Technology and are necessary or useful for researching, developing, commercializing, making, having made, using, importing, having imported, exporting, having exported, having sold, offering for sale, selling or otherwise disposing of a Product pursuant to this Agreement. For the purpose of clarity, the Licensor Patents Rights shall include all Patents covering an Improvement of the Technology owned or Controlled by Licensor.

1.38 “Lonza Research License Fee” has the meaning set forth in Section 6.2.2.

1.39 “Lonza Royalties” has the meaning set forth in Section 6.5.2.

1.40 “Losses” has the meaning set forth in Section 11.1.

1.41 “Management Representatives” has the meaning set forth in Section 12.1.

1.42 “Milestone Payments” means the payments set forth in Section 6.4.

1.43 “Net Sales” means the gross amounts actually received by Licensee or its Sublicensees for sales of a Product to Third Parties in the Territory (“Gross Sales”), less the following (to the extent applicable): (i) normal and customary trade, cash and quantity discounts on the Product actually allowed and taken directly by the customer with respect to the sales of the Product (other than price discounts granted at the time of invoicing and which are already included in the determination of Gross Sales), (ii) credits, deductions and allowances given or made for rejection or return of, and for uncollectible amounts on, a previously sold Product, (iii) taxes, duties or other governmental charges levied on or measured by the billing amount for the Product (excluding income and franchise taxes), to the extent included in the invoice price and not reimbursed by a Third Party, and (iv) charges for packing, handling, transportation, freight and insurance directly related to the distribution of a Product, to the extent included in Gross Sales.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE

COMMISSION


Sales between Licensee and any of its Sublicensees shall be excluded from the computation of Net Sales if such sales are not intended for end use, but Net Sales shall include the subsequent final sales to Third Parties by any such Sublicensees. If a sale, transfer or other disposition with respect to the Product involves consideration other than cash or is not at arm’s length, then the Net Sales from such sale, transfer or other disposition shall be the fair market value, which shall mean the selling party’s average sales price for the calendar quarter in the country where such sale, transfer or other disposition took place (“Average Sales Price”).

In the event Licensee or any of its Sublicensees sells or transfers units of a Product in conjunction with any other product and in so doing sells or transfers such units for an amount less than the sum of the weighted average selling price for such units of the Product sold separately, for the purposes of determining Net Sales from such sales or transfers, Net Sales shall be based upon the Net Sales price to a similar-sized customer ordering a similar volume of units of the Product under similar terms and conditions but sold separately.

In the event a Product is sold in any country in the form of a combination product containing one or more therapeutically active components other than Antibodies which active ingredients are not attached or linked to such Antibodies alone, Gross Sales shall be determined by multiplying the actual Gross Sales of such combination product by the fraction A/(A + B), where A is the invoice price of the Product containing an Antibody or a set of Antibodies alone, if sold separately, and B is the invoice price of any other active component or components in the combination, if sold separately, in each case in the same country and in the same dosage as the combination product. If, on a country-by-country basis, the other active component or components in the combination are not sold separately in such country, Gross Sales shall be calculated by multiplying the actual Gross Sales of such combination product by the fraction A/C where A is the invoice price of the Product containing an Antibody or a set of Antibodies alone if sold separately, and C is the invoice price of the combination product, in each case in the same country and in the same dosage as in the combination product. If, on a country-by-country basis, the component of the Product containing an Antibody or a set of Antibodies alone of the combination product is not sold separately in such country, but the other active component or components are sold separately, Gross Sales shall be calculated by multiplying actual Gross Sales of such combination product by the fraction (C-B)/C where B is the invoice price of the other active component or components, if sold separately, and C is the invoice price of the combination product, in each case in the same country and in the same dosage as the combination product. If, on a country-by-country basis, neither the Product containing an Antibody or a set of Antibodies alone nor the other active component or components of the combination product are sold separately in such country, Gross Sales, for such combination product shall be determined by the Parties in good faith.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.44 “Patents” means all patents and patent applications existing as of the Effective Date and all patent applications thereafter filed, including any continuation, continuation-in-part, division, provisional or any substitute applications, and any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplemental patent certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing.

1.45 “Phase I Clinical Trial” means a human clinical trial in any country that is intended to collect data on safety of a Product for a particular indication or indications in patients with the disease or indication under study or that would otherwise satisfy the requirements of 21 Code of Federal Regulations (“CFR”) §312.21(a) (U.S.) or its non-U.S. equivalent.

1.46 “Phase II Clinical Trial” means a human clinical trial in any country that is intended to collect data on dosage and evaluate the safety and the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study or that would otherwise satisfy the requirements of 21 Code of Federal Regulations (“CFR”) §312.21(b) (U.S.) or its non-U.S. equivalent.

1.47 “Phase III Clinical Trial” means a human clinical trial in any country that is intended to be a pivotal trial the result of which would be used to establish safety and efficacy of a Product as a basis for a BLA or that would otherwise satisfy the requirements of 21 CFR 312.21(c) or its non-U.S. equivalent.

1.48 “Potelligent ® CHOK1SV” means the FUT8 (-/-) knock-out CHOK1SV Cell Line jointly created by Lonza’s Affiliate, Lonza Biologics plc, and BioWa’s Affiliate, Kyowa Hakko Kirin Co., Ltd., by combining the CHOK1SV Cell Line and the Potelligent ® Technology.

1.49 “Potelligent ® Technology” means BioWa’s proprietary technology directly relating to the use of Potelligent ® Cells (as such term is defined in the 2008 License) to produce Antibodies with enhanced ADCC activity by reducing the amount of fucose linked to the carbohydrate chain, including (i) Potelligent ® Cells; (ii) [***]; (iii) protein expression, production or purification methods, therapeutic compositions, formulations or uses of, and other modifications to, [***]; and (iv) [***].

1.50 “Product” means any composition or formulation in the Field containing or comprising an Antibody owned by Licensee or licensed by Licensee from a Third Party, alone or in combination with other active or inactive ingredients, components or materials.

1.51 “Progress Report” has the meaning set forth in Article 5.

1.52 “Proposed Target” has the meaning set forth in Section 4.3.1.

1.53 “Prosecution and Maintenance” has the meaning set forth in Section 8.2.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.54 “Research” means research and non-clinical development activities performed up to the date of the Commencement of Phase I Clinical Trial for any Product, including the manufacture and use of any Product for research and non-clinical development only (but including batch manufacturing for Phase I Clinical Trials), but does not include human clinical studies or other commercialization activities, such as the manufacture, use, marketing and sale of any Product or any product containing or derived from a Product.

1.55 “Research License” has the meaning set forth in Section 2.1.1.

1.56 “Research Licensee Fee” has the meaning set forth in Section 6.2.

1.57 “Research Period” has the meaning set forth in Section 2.1.1.

1.58 “Research Target” means a Target proposed by Licensee and confirmed as available by the Third Party Reviewer for which Licensee may request a Commercial License as provided in Section 2.2

1.59 “Strategic Partner” means a Third Party with whom Licensee has entered into a contractual relationship (i) to collaborate in the performance of research or development, and/or commercialization of Product, (ii) under which such Third Party has a material interest in the commercial success of Product, and (iii) is not only intended to provide for the provision of services by such Third Party to Licensee. In no event may any entity that is primarily a Competing Contract Manufacturer be deemed a Strategic Partner for the purposes of this Agreement.

1.60 “Sublicensee” means any Third Party or an Affiliate of Licensee, to whom Licensee has granted any of its rights under Section 2.1.

1.61 “Target” means a polypeptide, a carbohydrate chain, or any other molecule to which an Antibody binds and/or which an Antibody modulates. A polypeptide Target shall be identified using the amino acid sequence coded by a single mRNA as identified by a UniGene number. A carbohydrate chain Target shall be identified according to the nomenclature of the Journal of Biological Chemistry.

1.62 “Technology” means Antibody expression and ADCC enhancing technology using Potelligent ® CHOK1SV in combination with the Transfection Supplements System, the Vectors and related Know-How and Patents, including but not limited to (i) Potelligent ® CHOK1SV; (ii) methods for selection of transfected cells; (iii) protein expression, production or purification methods [***]; (iv) therapeutic compositions, formulations or uses of, and other modifications to antibodies which are specific to antibodies with enhanced ADCC activity produced by transfected cells; and (v) [***].

1.63 “Term” has the meaning set forth in Section 7.1.

1.64 “Territory” means all countries and territories in the world.

1.65 “Third Party” means any entity other than Licensee, Licensor and their respective Affiliates.

1.66 “Third Party Reviewer” has the meaning set forth in Section 4.2.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


1.67 “Third Party Reviewer Agreement” has the meaning set forth in Section 4.2.

1.68 “Transfected Cells” means Potelligent ® CHOK1SV cells transfected by Licensee with recombinant DNA encoding a monoclonal antibody.

1.69 “Transfection Supplements” means the supplement solution set out in Exhibit 4.

1.70 “Transfection Supplements Know-How” means any Know-How owned or Controlled by Licensor specifically relating to the Transfection Supplements and which is provided to Licensee hereunder.

1.71 “Transfection Supplements System” means the Transfection Supplements and Transfection Supplements Know-How used either in combination or individually.

1.72 “U.S.” means the United States of America, including all commonwealths, territories, and possessions of the United States.

1.73 “Valid Claim” means an issued and unexpired claim of a Licensor Patent Right that has not been canceled, withdrawn, or rejected and has not lapsed or become abandoned or been declared invalid or unenforceable or been revoked by a court or agency of competent jurisdiction from which no appeal can be or has been taken.

1.74 “Vectors” means Lonza’s vectors identified in Section 3.1(a) below.

ARTICLE 2

LICENSE GRANTS AND COVENANTS

2.1 License Grants to Licensee . Subject to the terms and conditions of this Agreement and Section 2.8 below, Licensor hereby grants to Licensee the following:

2.1.1 Research License. A non-exclusive, fee-bearing license in and to the Licensor IP Rights, without the right to sublicense, to conduct Research for the purpose of identifying Antibodies suitable for commercialization (but not including commercialization) as Products in the Field in the Territory with respect to any Target (the Research License”). Such Research License shall commence on the Effective Date and continue for a period of [***] years or until otherwise terminated in accordance with Section 7 hereof, whichever is the earlier (“Research Period”), provided that the Research Period may be extended by mutual agreement of the Parties; and

2.1.2 Commercial License. Upon Licensor’s receipt from Licensee of the Commercial License Notification and payment of the Commercial License Fee, a fee- and royalty-bearing, non-exclusive license in and to the Licensor IP Rights, with the limited right to sublicense in accordance with Section 2.3, to develop, commercialize, make, have made, use, import, have imported, export, have exported, sell, have sold, offer for sale and otherwise dispose of any and all Products in the Field in the Territory with respect to [***] Commercial Targets (each, a “Commercial License”).

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


2.2 Commercial License Notification . As of the Effective Date of this Agreement, Licensee shall be deemed to have given notice that it desires to obtain a Commercial License for the first Research Target designated under the 2008 License, for which an IND was filed on July 27, 2010. [***].

2.3 Sublicense . Licensee may sublicense its rights under Section 2.1.2 to Third Parties, provided that such sublicenses shall be granted pursuant to the terms and conditions set forth in Sections 2.3.1 to 2.3.4 below.

2.3.1 [***]:

 

  (a) [***]

 

  (b) [***]

2.3.2 [***].

2.3.3 In each sublicense agreement, Licensee shall require the Sublicensee to comply with the applicable terms and conditions of this Agreement and shall include a provision that expressly assigns or grants to Licensee such of its right, title and interest in Improvements as are necessary in order for Licensee to comply with the requirements of Section 8.1 hereof.

2.3.4 In the event that Licensee fails to make payments pursuant to this Agreement, all payments due to Licensee from its Sublicensees under the sublicense agreements shall, upon notice from Licensor to the Sublicensees, become payable directly to Licensor for the account of Licensee.

2.4 [***]

2.4.1 [***]

2.4.2 [***]

2.4.3 [***]

2.5 Performance by Sublicensees [***] . Licensee’s execution of a sublicense [***] agreement shall not relieve Licensee of any of its obligations under this Agreement. Licensee shall remain jointly and severally liable to Licensor for any performance or non-performance of a Sublicensee [***] that would be a breach of this Agreement if performed or omitted by Licensee, and Licensee shall be deemed to be in breach of this Agreement as a result of such Sublicensee [***] performance or non-performance.

2.6 Licensor’s Rights . Except for the rights granted to Licensee under this Agreement, all right, title and interest in and to the Technology shall at all times remain with and be vested in Licensor. Neither Licensee (including its Affiliates) nor its Sublicensees [***] shall use the Technology for any purpose other than as expressly granted to Licensee under this Agreement.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


2.7 Third Party Rights and Licenses . Except for Licensor IP Rights, rights in and to Technology, and unless otherwise provided herein, Licensee shall be responsible for obtaining all rights from Third Parties or Licensor’s Affiliates that are necessary to research, develop and commercialize the Products in the Field.

2.8 Permitted Uses of the Technology; Prohibition on Modifications or Adaptations . Licensee’s use of the Technology is limited to inserting gene(s) coding for Licensee’s proprietary antibodies into the Vectors and then into Potelligent ® CHOK1SV for the purpose of generating Antibodies and exercising the licenses set forth herein. Licensee hereby undertakes not to make any modifications or adaptations to the [***] during the Term of this Agreement except as explicitly provided under this Section 2.8 hereto. Licensee is specifically prohibited from performing any analysis, test, experiment or reverse-engineering of [***].

2.9 Applicability of 2008 License. The 2008 License shall remain valid, absent termination by either BioWa or Licensee, in accordance with its terms and shall govern Licensee’s Research, development and commercialization of Products utilizing or incorporating only BioWa’s Potelligent Technology. This Agreement shall govern Licensee’s Research, development and commercialization of Products utilizing or incorporating the Technology. [***].

2.10 Applicability of Lonza License. The Lonza License shall remain valid, absent termination by either Lonza or Licensee, in accordance with its terms, and shall govern Licensee’s research, development and commercialization of Products utilizing or incorporating only Lonza’s GS System and Transfection Medium System, as those terms are defined in the Lonza License. Notwithstanding anything to the contrary, it is understood and agreed that, on an annual basis, Licensee shall pay to Lonza the fee set forth in Section 6.3 of the Lonza License for Licensee’s research, development and commercialization of Products utilizing or incorporating only Lonza’s GS System and Transfection Medium System and the Research License Fee set forth in Section 6.2.2 herein for Licensee’s research, development and commercialization of Products utilizing or incorporating the Technology.

ARTICLE 3

MATERIAL TRANSFER AND OBLIGATIONS

3.1 Provision of Materials . Following the signature of this Agreement by all Parties, and only upon Licensee’s written request therefor, Lonza shall supply to the Licensee (ex-works Lonza’s Affiliate’s premises, Slough, Berkshire, Incoterms 2000) the following in accordance with the procedures and terms agreed by Lonza and Licensee:

 

  (a) Vectors

Approximately [***] of vector [***].

Approximately [***] of vector [***].

 

  (b)

Potelligent ® CHOK1SV

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


[***] vials of viable Potelligent ® CHOK1SV.

 

  (c) Licensor Know-How

[***], and (c) Vector nucleotide sequences.

In relation to the Transfection Supplements System, Lonza shall (a) provide Licensee with details of at least one third party supplier from whom Licensee will be able to purchase Transfection Supplements, and (b) supply Licensee with the Transfection Supplements Know-How. For the avoidance of doubt, Licensee hereby confirms that Licensor may disclose to such third party supplier the fact that Licensee is a party to this Agreement.

3.2 Provision of Technical Support . During the Research Period, if requested by Licensee, Licensor shall provide technical assistance to Licensee in relation to the use of the Technology at a rate of [***] per man day and any travel and subsistence costs. This rate is valid for twelve (12) months from the Effective Date hereof and is subject to review and adjustment thereafter.

3.3 Sole Uses of Technology . Licensee shall not use the Transfection Supplements, Vectors, Potelligent ® CHOK1SV or Licensor IP Rights for any purpose other than that permitted in Section 2.1. Upon transfection, Licensee shall have the right to use the Transfected Cells solely to Research, develop, commercialize, make, have made, use, import, have imported, export, have exported, sell, have sold, offer for sale, and otherwise dispose of Products pursuant to the terms and subject to the conditions of this Agreement. Except as specifically provided in this Agreement, Licensee shall not offer for sale, sell, transfer or otherwise distribute Potelligent ® CHOK1SV, Transfected Cells, or Licensor IP Rights to any Third Party. Licensee shall store, handle, transport, use and dispose of Potelligent ® CHOK1SV and Transfected Cells in accordance with all applicable country, state and local laws and regulations.

3.4 [***].

ARTICLE 4

TARGET DESIGNATION

4.1 Target Designation . Licensee designated an initial Research Target under the 2008 License, in accordance with the terms and conditions set forth therein. Licensee shall have the right to designate [***] during the Research Period in accordance with the procedures set forth in Section 4.3.

4.2 Third Party Reviewer Agreement . On the Effective Date, BioWa and Licensee shall enter into a third party reviewer agreement with Blank Rome LLP (the “Third Party Reviewer”) in the form attached hereto as Exhibit 2 (the “Third Party Reviewer Agreement”). Licensee shall be responsible for paying the Third Party Reviewer’s fees for all services performed, as provided in the Third Party Reviewer Agreement.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


4.3 Mechanism for Designating Research Targets. Except as set forth in Section 4.4 below, Licensee shall use the mechanism described in this Section 4.3 to designate Research Targets.

4.3.1 At any time during the Research License Period, Licensee may provide to the Third Party Reviewer the identity of any an additional Proposed Target it wishes to reserve as a Research Target (“Proposed Target”).

4.3.2 The Third Party Reviewer maintains a list of Targets (“Target List”), which are Targets that have been (i) designated by BioWa, its Affiliates or any Third Party licensees of BioWa (“Third Party Licensees”) on a non-exclusive basis, (ii) designated by BioWa or its Affiliates exclusively for its or their own drug discovery programs, or (iii) to which BioWa has granted licenses or reserved exclusively for Third Parties, and so are not available for any other commercial license. The Targets described in subsections (ii) and (iii) are designated “Excluded Targets”).

4.3.3 The Third Party Reviewer shall notify Licensee whether such Proposed Target is available to Licensee as a Research Target no later than thirty (30) days after receiving a notice of the identity of a Proposed Target from Licensee under Section 4.3.1 above. Unless a Proposed Target is an Excluded Target, it shall be deemed available to Licensee as a Research Target for purposes of this Agreement and added to the Target List. If a Proposed Target is successfully designated as a Research Target, Third Party Reviewer shall notify BioWa in writing, within thirty (30) days of receiving Licensee’s notice of the identity of Proposed Target(s), that a Proposed Target (but not the identity of the same) has been designated as a Research Target. For the avoidance of doubt, BioWa shall not cause the Third Party Reviewer to reveal the identity of any Proposed Target (even if it is deemed to be an Excluded Target) or any Research Target to BioWa or to any Third Party at any time.

4.3.4 Licensee acknowledges that until a Proposed Target is confirmed by the Third Party Reviewer to be available and designated as a Research Target, any such Proposed Target may be subject to exclusive designation, non-exclusive designation or reservation by BioWa, its Affiliates or a Third Party. For the purpose of clarity, after a Proposed Target is confirmed to be available and designated as a Research Target by Licensee, such Research Target is confirmed to be a non-exclusive reservation of such Proposed Target by Licensee, and BioWa shall not grant to any Affiliates or Third Party or reserve for itself an exclusive license for such Research Target during the Term.

4.4 Designation of Target Under 2008 License. The Parties hereby acknowledge and agree that the Target initially designated by Licensee under the 2008 Agreement and identified as [***] shall, as of the Effective Date, be deemed a Target designated under this Agreement and shall be governed by the terms and conditions of this Agreement.

4.5 [***].

4.6 Notification of Commencement of Phase I Clinical Trials. Within [***] days of Commencement of Phase I Clinical Trials for each Product, Licensee shall provide Licensor written notice of such Commencement of such Trial and such notice shall (i) specifically identify the Commercial Target; and (ii) specifically identify the Antibody or Product being developed.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


4.7 Abandoned Targets.

4.7.1 Abandonment . Licensee shall be deemed to have abandoned development and commercialization of any Antibody or any Product with respect to a Commercial Target upon the earlier of (i) written notice from Licensee to Licensor of the abandonment; or (ii) receipt of [***] Progress Reports showing no diligent activity by the Licensee with respect to such Commercial Target.

4.7.2 Effect of Abandonment. Licensee’s abandonment of a Commercial Target shall entitle Licensor to terminate the respective Commercial License as its sole remedy for such abandonment.

ARTICLE 5

PROGRESS REPORTS

During the Term, and subject to Licensee’s right and obligation not to reveal the identity of a Commercial Target until the Commencement of Phase I Clinical Trials as set forth in Section 4.3, Licensee shall deliver to Licensor annual, written, reasonably detailed progress reports, following the format set forth in Exhibit 3, of Activities conducted by Licensee and its Sublicensees in the preceding calendar year, including Licensee’s progress towards the achievement of milestone events set forth in Section 6.3 (the “Progress Report”). The first Progress Report shall be due on the first anniversary of the Effective Date, and subsequent Progress Reports on each anniversary of the Effective Date thereafter.

ARTICLE 6

FINANCIAL TERMS

6.1 Signing Fee . Licensee shall pay to BioWa a one-time signing fee in the amount of [***] (“Signing Fee”) upon execution of this Agreement. If the Continuing Access Fee has been paid by Licensee to BioWa under the 2008 Letter Agreement prior to the Effective Date hereof, that Continuing Access Fee shall be creditable against the Signing Fee.

6.2 Research License Fee.

6.2.1 BioWa Research License Fee. Subject to the terms of Section 2.9, for the first Research Target, designated under the 2008 License, Licensee shall pay to BioWa an annual, non-refundable, non-creditable research licensee fee of [***] (the “BioWa [***]Target Research License Fee”), due and payable on each anniversary of September 2, 2008, until the termination of the Research Period or until Licensee obtains a Commercial License for such [***] Research Target. For the right to conduct Research under Section 2.1.1. and to designate a [***] Research Target under this Agreement, Licensee shall pay to BioWa an annual, non-refundable, non-creditable research license fee of [***] (“BioWa [***]Target Research License Fee”), due and payable within [***] Business Days of the Effective Date and upon each anniversary of the Effective Date hereof, until the termination of the Research Period. [***].

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


6.2.2 Lonza Research License Fee. Licensee shall pay to Lonza an annual, non-refundable, non-creditable research license fee of [***] (the “Lonza Research License Fee”), due and payable on the date Licensee elects to receive the materials set forth in Section 3.1 hereof and thereafter on each anniversary of Licensee’s receipt of the Section 3.1 materials, [***]. For clarity, the Lonza Research License Fee is due only if Licensee, or a designated Sublicensee acting on Licensee’s behalf, elects to receive the Section 3.1 materials.

6.3 Commercial License Fee . Subject to the terms of Section 2.9, for the first Commercial License obtained by Licensee hereunder, Licensee shall pay to BioWa an annual, nonrefundable, non-creditable commercial license fee of [***] (the “[***]Target Commercial License Fee”) and, as described in Section 2.2, [***].

6.4 Milestone Payments .

6.4.1 BioWa Milestone Payments. Licensee shall make the following non-refundable and non-creditable milestone payments to BioWa upon achievement of the first occurrence of the following milestone events, on a Target-by-Target basis, by Licensee or a Sublicensee thereof:

(a) [***] upon Commencement of the first Phase I Clinical Trial; provided that if the IND milestone payment has been made under the 2008 License, [***];

(b) [***] upon Commencement of the first Phase II Clinical Trial; provided that if the IND milestone payment has been made under the 2008 License, [***];

(c) [***] upon Commencement of Phase III Clinical Trials comprised of the following:

 

  (i) [***]

 

  (ii) [***];

[***].

(d) [***] upon submission of a BLA, comprised of the following:

 

  (i) [***]

 

  (ii) [***];

[***].

(e) [***] upon Licensee receipt of approval of a BLA, comprised of the following:

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


  (i) [***]

 

  (ii) [***];

[***].

(f) In partial consideration of the licenses granted under this Agreement, Licensee shall pay to BioWa the following sales milestone payments (“Sales Milestone”), payable upon the achievement of the corresponding sales milestone event on each Product within thirty (30) days of Licensee’s receipt of an invoice from BioWa therefor.

 

  (i) [***];

 

  (ii) [***];

 

  (iii) [***].

6.5 Royalty Payments.

6.5.1 BioWa Royalty Payments. Licensee shall pay to BioWa tiered running royalties (the “BioWa Royalties”), on a Target-by-Target basis, equal to the following rates:

(a) [***] of Net Sales for a Product sold by Licensee or its Sublicensees (including its Affiliates) to unrelated Third Parties where annual global sales for such Product are [***];

(b) [***] for such Product sold by Licensee or its Sublicensees (including its Affiliates) to unrelated Third Parties where annual global sales for such Product [***]

(c) [***] of the portion of Net Sales of a Product exceeding [***] for such Product sold by Licensee or its Sublicensees (including its Affiliates) to unrelated Third Parties where annual global sales for such Product are [***].

Notwithstanding anything else in this Agreement, [***]; provided, however, that in no case shall the Royalties payable hereunder be less than [***] during the Term. Any reduction in Royalties under this provision shall be limited to the Product(s) and/or countries encompassed by the adjudication or settlement.

6.5.2 Lonza Royalty Payments. During the Term, Licensee shall pay to Lonza running royalties (the “Lonza Royalties”) as follows:

(a) In respect of Product manufactured by Lonza, a royalty of [***] of the Net Sales for such Product.

(b) Where Licensee or Licensee’s Strategic Partner manufactures Product:

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


  (i) a payment of [***] due annually during the course of this Agreement, and being first payable upon Commencement of Phase II Clinical Trials for such Product; and

 

  (ii) a royalty of [***] of the Net Sales for such Product.

(c) Where any party other than Lonza, Licensee, Licensee’s Affiliates or Licensee’s Strategic Partner manufactures Product:

 

  (i) a payment of [***] per sublicense due annually during the course of such sublicense, and being first payable on the commencement date of the relevant sublicense; and

 

  (ii) a royalty of [***] of the Net Sales for such Product.

Notwithstanding anything else in this Agreement, [***] provided, however, that in no case shall the Royalties payable hereunder be less than [***] of the applicable Lonza Royalty payable under Section 6.4.2. Any reduction in Royalties under this provision shall be limited to the Product(s) and/or countries encompassed by the adjudication or settlement.

6.5.3 Duration of Payments. Royalties will be payable by Licensee until the later of (i) ten (10) years from the date of First Commercial Sale of the first Product, or (ii) the expiration of the last-to-expire patent within the IP Rights (“Royalty Term”). Thereafter, subject to Section 6.5.4 below, the license under this Agreement for the Target shall become fully paid up.

6.5.4 Product Sold in Countries Not Protected by a Valid Claim. In the event Product is sold in a country in which there is no Valid Claim covering such Product, or in which previously existing Valid Claims covering such Product have expired or otherwise become invalid, royalties shall be due only in respect of the Licensor Know-How and the relevant royalty figures referred to in Sections 6.5.1 shall be reduced by [***] percent [***]%) for the duration of the Royalty Term, and the relevant royalty figures referred to in Section 6.5.2 shall be reduced by [***] percent [***]%). For the duration of the Royalty Term Thereafter, the license under this Agreement for such Product shall become fully paid-up.

6.6 Notification Obligations and Payment Dates for Milestone Payments and Royalties . Licensee shall inform Licensor in writing within fifteen (15) days of achieving each milestone by Licensee or its Sublicensee under this Agreement. Licensee shall make the relevant Milestone Payment within thirty (30) Business Days of confirmation of achieving such milestone. All Royalty payments under Section 6.5 shall be due and payable quarterly and within thirty (30) Business Days of the close of the Calendar Quarter during which the corresponding Net Sales are recognized. In the event that the amounts due to Licensor pursuant to Section 6.5 would increase based on total Net Sales at the end of the applicable calendar year, then Licensee shall promptly pay to Licensor the difference between the amounts paid and the amounts that would have been due based on the total Net Sales at the end of the applicable calendar year. Together with any such payment, Licensee shall deliver a

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


report specifying in the aggregate and on a country-by-country basis: (i) total gross invoiced amount from sales of the Products by Licensee and its Sublicensees; (ii) amounts deducted, by category, from gross invoiced amounts to calculate Net Sales; (iii) Net Sales; and (iv) royalties payable. For purposes of computing royalty payments for Net Sales payable to BioWa made outside of the U.S., such royalties shall be converted into U.S. Dollars by applying the rate of exchange quoted in the New York edition of The Wall Street Journal on the last Business Day of the applicable Calendar Quarter. For purposes of computing royalty payments for Net Sales payable to Lonza made outside of the U.K., such royalties shall be converted into pounds sterling, and the rate of exchange shall be the mean value of the Pound Spot Rate in London first published in the Financial Times on the day following the day for determining such rates.

6.7 Late Payment . Any payments or portions thereof due to Licensor hereunder which are not paid when due shall bear interest equal to the lesser of the prime rate as reported by the Chase Manhattan Bank, New York, New York, U.S., on the date such payment is due, plus an additional [***] per annum, or the maximum rate permitted by law, calculated on the number of days such payment is delinquent. This Section 6.7 shall in no way limit any other remedies available to Licensor for late payments. Failure to make any payments pursuant to the terms of this Agreement hereunder shall constitute a breach of this Agreement.

6.8 Mode of Payment .

6.8.1 Mode of Payment to BioWa. All payments to BioWa hereunder shall be made in U.S. Dollars in the stated amount by wire transfer to such bank account as BioWa may from time to time designate by notice in writing to Licensee. Until otherwise designated by notice, the fees payable to BioWa under this Article 6 shall be paid to [***], account number [***]. Payments shall be free and clear of any taxes, fees or charges, to the extent applicable.

6.8.2 Mode of Payment to Lonza. All payments to Lonza hereunder shall be made in pounds sterling in the stated amount by wire transfer to such bank account as Lonza may from time to time designate by notice in writing to Licensee. Until otherwise designated by notice, the fees payable to Lonza under this Article 6 shall be paid to: account no. [***].

6.9 Records Retention and Audit . With respect to each Product, Licensee shall keep, and shall cause its Sublicensees, and their respective agents, to keep for as long as legally required and in no event less than five (5) years, complete, true and accurate books of accounts and records of all quantities of Products manufactured and sold (or otherwise distributed) in sufficient detail to confirm the accuracy of the Net Sales and royalty calculations hereunder. Upon reasonable prior written notice from Licensor, during the Term and for three (3) years thereafter, no more than once per twelve month period, Licensee shall permit an independent certified public accountant, appointed and paid by Licensor, and reasonably acceptable to Licensee, at reasonable times during normal business hours and under a written confidentiality agreement between the accountant and Licensee executed prior to the inspection, to examine these records solely to the extent reasonably necessary to verify such calculations for any calendar year ending not more than thirty-six (36) months prior to

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


the date of such request. Such investigation shall be at the expense of Licensor, unless it reveals a discrepancy in Licensee’s favor of more than [***], in which event Licensee shall reimburse Licensor for the accountant’s fees related thereto. If such investigation shows underpayment of royalties, Licensee shall promptly (but in no event later than thirty (30) days after Licensee’s receipt of the independent auditor’s report so correctly concluding) remit to Licensor the amount of such underpayment, and all such payments shall be subject to the accrual of interest pursuant to Section 6.7. Licensee shall ensure that all Sublicensees comply with Licensee’s obligations under this Section.

6.10 Tax Withholding . All payments required under this Agreement shall be without deduction or withholding for, or on account of, any taxes or similar governmental charge imposed by any jurisdiction. Any withholding taxes shall be the sole responsibility of the paying Party. The Party receiving payment agrees to elect to claim a tax credit for any such withholding taxes paid by the paying Party for which the receiving Party is entitled to so elect, and at the time the receiving Party actually realizes a reduction in its regular income tax liability by utilizing any such withholding taxes as a credit against its regular income tax liability (determined on a “first in first out” basis pro rata with other available foreign tax credits), then the amount of such credit shall be promptly reimbursed to the paying Party, to the extent such withholding taxes were paid by the paying Party.

6.11 Blocked Payments . In the event that, by reason of applicable laws or regulations in any country, it becomes impossible or illegal for Licensee or its Sublicensees to transfer, or have transferred on its or their behalf, royalties or other payments to Licensor, such royalties or other payments shall be deposited in local currency in the relevant country to the credit of Licensor in a recognized banking institution designated by Licensor or, if none is designated by Licensor within a period of thirty (30) days, in a recognized banking institution selected by Licensee or its Sublicensees, as the case may be, and identified in a written notice to Licensor.

ARTICLE 7 -

TERM AND TERMINATION

7.1 Term and Expiration . This Agreement shall become effective on the Effective Date and unless earlier terminated pursuant to this Article 7, shall remain in full force and effect until there are no remaining Royalty payment obligations with respect to any Product in any country (the “Term”).

7.2 Termination at Will by Licensee . Licensee shall have the right to terminate this Agreement in its entirety or on a Commercial License-by-Commercial License basis for any reason upon ninety (90) days prior written notice to Licensor. Upon termination in accordance with this Section 7.2, the licenses granted by Licensor pursuant to Article 2 shall terminate with regard to each Target for which a Commercial License has been terminated as provided above, or for all Targets, if this Agreement is terminated in its entirety. Licensee shall remain obligated for all payments due at the time of such notice and for any continuing obligations otherwise surviving and owed under this Agreement pursuant to Section 7.9 with regard to each terminated Commercial License and with regard to Targets for which the Commercial License has not been terminated by Licensee pursuant to this Section .

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


7.3 Termination for Breach.

7.3.1 Without prejudice to any other remedies that may be available under this Agreement, in the event that Licensee, on the one hand, or Licensor, on the other hand, has materially breached this Agreement, and the breaching Party has not cured such breach (to the reasonable satisfaction of the non-breaching Party) within sixty (60) days (or such longer period as may be agreed by the Parties if Licensee is exercising diligent efforts to cure such breach and sixty (60) days is insufficient to cure such breach) following its receipt of written notice thereof from the non-breaching Party, the non-breaching Party may terminate this Agreement, in whole or in part on a Commercial License-by-Commercial License basis (at the sole discretion of the non-breaching Party) by providing written notice to the other Party with immediate effect. Notwithstanding the above, in the case of a failure to timely pay any undisputed amounts due hereunder, the period for cure of any such breach shall be thirty (30) days following the non-breaching Party’s delivery of notice thereof and, unless payment is made within such thirty (30) day period, the non-breaching Party may thereafter terminate this Agreement by providing written notice to the other Party with immediate effect.

7.3.2 Notwithstanding the foregoing, (i) if such uncured material breach by Licensee involves only a specific Product or Target, or (ii) a specific Sublicensee or Third Party Contractor (and the Licensee has complied with its obligations under Sections 2.3 and 2.4), then Licensor may terminate this Agreement only with respect to Licensee’s rights relating, respectively, to such Product or Target or such Sublicensee or Third Party Contractor. If there has been an uncured material breach by a Sublicensee or a Third Party Contractor, and the Licensee has not complied with its obligations under Section 2.3 with regard to a such Sublicensee or Section 2.4 with regard to such Third Party Contractor, then Licensor may terminate this Agreement in whole, without regard to the number of Products, Targets, Sublicensees or Third Party Contractors licensed hereunder. For clarity, a breach by Licensee and/or a Sublicensee and/or a Third Party Contractor of the provisions of Sections 2.3, 2.4, 2.6, 2.8, 3.3, 8.1 and Article 9, shall be deemed a material breach of this Agreement.

7.4 Termination for Challenging IP Rights. If at any time during the Term of this Agreement, Licensee knowingly, directly or indirectly, opposes or assists any Third Party in opposing the grant of letters patent or any patent application within any of the Licensor Patent Rights, or disputes or knowingly, directly or indirectly, assists any Third Party in disputing the validity of any Patent within any of the Licensor Patent Rights or any of the claims thereof, Licensor shall be entitled at any time thereafter to terminate all or any of the licenses granted hereunder forthwith by notice to Licensee.

7.5 Termination for Insolvency . Either Licensor or Licensee may terminate this Agreement by written notice with immediate effect if the other is judicially declared to be insolvent, makes an assignment for the benefit of creditors, is the subject of proceedings in a voluntary or involuntary bankruptcy proceeding instituted on behalf of or against such Party (except for involuntary bankruptcies which are dismissed within ninety (90) days), or has a receiver or trustee appointed for substantially all of its property.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


7.6 Accrued Rights and Obligations . Termination or expiration of this Agreement, in whole or in part on a Commercial License-by-Commercial License basis, for any reason shall not (a) release any Licensor or Licensee from any liability which, at the time of such termination or expiration, has already accrued or which is attributable to a period prior to such termination or expiration or (b) preclude any Licensor or Licensee from pursuing any rights and remedies it may have hereunder, or at law or in equity, with respect to any breach of, or default under, this Agreement. Licensor or Licensee understand and agree that monetary damages may not be a sufficient remedy for a breach of this Agreement and that the Licensor or Licensee may be entitled to injunctive relief as a partial remedy for any such breach.

7.7 Inventory on Hand. Upon termination of this Agreement for any reason, Licensee and its Sublicensees may complete any production batches of Product in process at the date of such termination and sell or otherwise distribute the inventory of any Product then on hand until the second anniversary of the date of such termination. All such sale or distribution shall be subject to the relevant terms of this Agreement (including the payment of royalties thereon).

7.8 Destruction of Biological Materials. Upon termination (but not expiration) of this Agreement, Licensee and its Sublicensees shall promptly destroy all Potelligent ® CHOK1SV, Vectors, Transfection Supplements, and all Transfected Cells, as well as all Antibodies, and an officer of Licensee shall provide Licensor with a written certification to such effect. Notwithstanding the foregoing, the Parties may continue to exercise the rights granted in Section 7.7.

7.9 Licenses. The license(s) granted to Licensee in this Agreement shall terminate upon any termination of this Agreement and, in such event, Licensee shall cease, and cause its Sublicensees to cease, all uses of Licensor IP Rights or the Technology for any purposes, including but not limited to, the Research, development, manufacturing and commercialization of any Product. Notwithstanding the foregoing, the Parties may continue to exercise the rights granted in Section 7.7.

7.10 Survival . The following provisions of this Agreement shall survive expiration or termination of this Agreement: Article 1; Section 2.5 (regarding performance by Sublicensees and Third Party Contractors); Section 2.6 (regarding Licensor’s retained rights); Section 2.8 (regarding limits on Licensee’s use of the Technology); Section 3.3 (regarding sole uses of Technology); Section 3.4 (regarding Licensee’s rights in Transfected Cells); Article 6 (regarding payment obligations incurred prior to termination or expiration, record retention and audit rights); Sections 7.6 through 7.10; Section 8.1 (regarding the ownership of IP rights); Section 8.2 (regarding Patent prosecution); Article 9 (regarding confidentiality); Sections 10.2 and 10.3 (regarding warranties accrued prior to termination or expiration); Sections 10.4, 10.5 and 10.6 (regarding warranty disclaimers); Article 11 (regarding indemnifications and limitation of liability); Article 12 (regarding dispute resolution); and Article 13 (regarding miscellaneous provisions).

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 8 -

INTELLECTUAL PROPERTY

8.1 Ownership of IP .

8.1.1 General . [***] shall be owned by Licensor, and Licensee hereby assigns to Licensor its entire right, title and interest in and to any Improvements developed, conceived, reduced to practice, or invented by Licensee or its Sublicensees pursuant to the Activities contemplated by this Agreement. Licensee shall disclose or cause to be disclosed to Licensor all Improvements made by or under authority of Licensee or its Sublicensees pursuant to the Activities contemplated by this Agreement during the Term. Licensee (including its Sublicensees) shall maintain records in sufficient detail and in good scientific manner to properly reflect all work done and results achieved in connection with Improvements hereunder. Licensee (including its Sublicensees) shall promptly execute all documents and take all such other actions as may be reasonably requested to enable Licensor to Prosecute and Maintain Patents on the Improvements.

 

  8.1.2 [***], shall be owned by Licensee; provided, that, Licensee hereby grants to Licensor a non-exclusive, sublicensable (through multiple tiers), perpetual, irrevocable license in and to any such unseverable Improvements for use in connection with the Technology.

 

  8.1.3 Licensee Product Improvements . [***], shall be owned by Licensee. For clarity, the Antibodies and Products are deemed to be severable from the Technology, and not subject to either Section 8.1.1 or 8.1.2.

8.2 Patent Prosecution. As between Licensor and Licensee, Licensor shall have the right, at its expense, to control the Prosecution and Maintenance of the Licensor Patent Rights and any Patents on Improvements owned by Licensor as provided under Section 8.1.1 above, using counsel of its choice. As used in this Article 8, “Prosecution and Maintenance” (and “Prosecute and Maintain”) shall mean the preparing, filing, prosecuting and maintenance of such Patents, as well as re-examinations, reissues, requests for patent term extensions and the like with respect to such Patents, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to such Patents.

8.3 Infringement by Third Party . Subject to the provisions of this Section 8.3, in the event that Licensee becomes aware that any Licensor Patent Right is being infringed by a Third Party or is subject to a declaratory judgment action arising from such infringement, Licensee shall promptly notify Licensor. Licensor shall have the sole right (but not the obligation) to enforce the Licensor Patent Rights covering the Technology (an “Enforcement Action”). Licensee shall reasonably cooperate with Licensor in all such actions or proceedings. Licensee agrees to be joined as a plaintiff if necessary and shall provide all reasonable cooperation (including any necessary use of its name) required to prosecute such litigation at Licensor’s cost and expense. Licensor shall have the sole benefit of any damages collected from any such Enforcement Action.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


8.4 Third Party Infringement Claims. Licensee shall promptly notify Licensor in writing of any claims that Licensee’s use of the Licensor Patent Rights and/or Licensor Know-How infringes or improperly or unlawfully uses the proprietary rights of any Third Party. Licensor shall have the sole right and the obligation to use commercially reasonable efforts to take all such steps and proceedings and to do all other acts and things as may in Licensor’s sole discretion be necessary to defend such claims and Licensee shall permit Licensor to have the sole conduct of any such steps and proceedings, including the right to settle them. Licensee hereby agrees to use commercially reasonable efforts to co-operate fully with Licensor at Licensor’s cost and expense. Licensor shall be entitled to retain any and all monies received from such proceedings.

8.5 Product Markings and Trademarks . Each Product marketed and sold by Licensee or its Sublicensees under this Agreement shall be marked with all patent and other intellectual property notices relating to the Licensor Patent Rights as may be required by applicable law. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee a non-exclusive, revocable license, with the limited right to sublicense to its Sublicensees, to use and display the “Potelligent ® CHOK1SV™” trademark solely for marking the Products, if required, under this Section 8.5.

ARTICLE 9 -

CONFIDENTIALITY AND PUBLICATION

9.1 Confidential Information . The Parties recognize that each Party’s Confidential Information constitutes highly valuable and proprietary assets of the disclosing Party.

9.1.1 The Parties agree that Confidential Information shall not be deemed to include information that the receiving Party can demonstrate by written documentation:

9.1.1.1 is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, in the public domain or generally publicly available;

9.1.1.2 is rightfully known by the receiving Party or its Affiliates without restriction on disclosure at the time of receiving such information, as evidenced by credible evidence;

9.1.1.3 is furnished to the receiving Party or its Affiliates by a Third Party under no obligation of confidentiality, as a matter of right and without restriction on disclosure; or

9.1.1.4 is independently discovered or developed by the receiving Party or its Affiliates without reference to or use of the disclosing Party’s Confidential Information.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


9.1.2 Each Party agrees that, notwithstanding the termination or expiration of this Agreement, the receiving Party shall maintain all Confidential Information of a disclosing Party in confidence and shall not publish, disseminate or otherwise disclose a disclosing Party’s Confidential Information to any Third Party, nor use any Confidential Information of a disclosing Party, without the written consent of the disclosing Party, except for the purpose of this Agreement as provided in this Article 9. Notwithstanding the foregoing, the receiving Party may disclose and disseminate Confidential Information of the disclosing Party only to those Affiliates, Sublicensees, employees or contractors of the receiving Party who have a bona fide need to know for the purpose of this Agreement, and only after such Affiliates, Sublicensees, employees or contractors have been advised of the confidential nature of such information and are bound in writing by an obligation of confidentiality under terms substantially similar to, and as protective of the disclosing Party as, the confidentiality obligations in this Agreement. Notwithstanding anything to the contrary, unless it has obtained Licensee’s prior written consent, Licensor shall not disclose any Confidential Information of Licensee to any Affiliate of Licensor (including, without limitation, Kyowa Hakko Kirin Co., Ltd.) that is involved in research or development relating to human therapeutics. For clarity, Licensor’s routine financial reporting to an Affiliate (including, without limitation, Kyowa Hakko Kirin Co., Ltd.) shall not been deemed a prohibited disclosure of Licensee’s Confidential Information.

9.2 Permitted Use and Disclosures . Each receiving Party may (i) use Confidential Information of a disclosing Party to exercise its rights or perform its obligations hereunder, or (ii) use or disclose Confidential Information of a disclosing Party to the extent such use or disclosure is reasonably necessary in (a) complying with applicable governmental regulations or otherwise submitting information to governmental authorities, (b) conducting clinical trials or applying for regulatory approvals, and (c) negotiating or making a permitted sublicense, provided that if a receiving Party is required to make any such disclosure of a disclosing Party’s Confidential Information pursuant to clause (ii)(a), it shall make commercially reasonable efforts to: (w) give prompt written notice to the disclosing Party of the proposed disclosure to the relevant governmental authority, and allow the disclosing Party at least thirty (30) days to object to all or any portion of the disclosure before it is disclosed; (x) if advance notice is not possible, provide written notice of disclosure immediately thereafter; (y) to the extent possible, minimize the extent of such disclosure; and (z) secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise), it being understood that any information so disclosed shall otherwise remain subject to the limitations on use and disclosure hereunder. The Party proposing to disclose any Confidential Information under this provision shall take into reasonable consideration any comments and objections raised by the disclosing Party.

9.3 Press Releases . The text of any press release or other communication to be published by or presented in the media concerning the subject matter of this Agreement shall require the prior written approval of all Parties, except as may be required by law or regulation.

9.4 Disclosures Required by Law . If a public disclosure is required by law, rule or regulation, including in a filing with the Securities and Exchange Commission, the disclosing Party shall provide copies of the disclosure reasonably in advance of such filing or

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


other disclosure, but not later than ten (10) Business Days prior to the filing, for a non-disclosing Party’s prior review and comment and to allow a non-disclosing Party a reasonable time to object to any such disclosure or to request confidential treatment thereof. Notwithstanding the foregoing, the Parties hereby agree to issue a press release subsequent to the Effective Date, the content of which shall be approved by the Parties as soon as practical.

9.5 Review of Proposed Publications, Presentations or Patent Applications . No Party shall publish any manuscript, abstract, specification, text and/or any other material (“Materials”) that includes information about this Agreement or another Party’s Confidential Information without providing a copy of the materials to the reviewing Parties and obtaining such other Parties’ consent pursuant to this Section 9.5. For clarity, this shall not limit Licensee from publishing its research or clinical results relating to any Product (including without limitation the results of any clinical trial), provided that Licensee may not disclose another Party’s Confidential Information. Without the consent of Licensor, Licensee shall not publish any Materials that disclose Confidential Information of Licensor. Without the consent of Licensee, Licensor shall not publish any Materials relating to any Product. A receiving Party shall review any such materials provided to it by the publishing Party to determine if Confidential Information is or may be disclosed. A reviewing Party shall notify the publishing Party in writing within thirty (30) calendar days after receipt of the proposed publication if the receiving Party determines that Confidential Information of the reviewing Party is or may be disclosed. If it is determined by the receiving Party that patent applications should be filed, the publishing Party shall delay its submission for publication or presentation for a period not to exceed sixty (60) calendar days from the reviewing Party’s receipt of the proposed publication to allow time for filing of one or more patent applications. In the event that the delay needed to complete the filing of any necessary patent application exceeds the 60-day period, the Parties shall discuss the need for obtaining an extension of the publication delay beyond the 60-day period. If it is determined by the reviewing Party that Confidential Information of such Party is being disclosed, the publishing Party shall comply with any request to remove the Confidential Information from the proposed publication to avoid such disclosure.

9.6 Confidential Terms . Except as expressly permitted in this Agreement, no Party shall disclose any terms of this Agreement to any Third Party without the prior written consent of the other Parties; except that such consent shall not be required for disclosure to actual or prospective investors or acquirers or to a Party’s accountants, attorneys and other professional advisors (provided that such disclosures shall be subject to continued confidentiality obligations at least as strict as are set forth herein).

9.7 Return or Destruction of Confidential Information . Upon termination or expiration of this Agreement, Licensor and Licensee shall each, at its sole discretion, either promptly return to the other all Confidential Information of the other (including any copies or extracts thereof) or destroy all such Confidential Information and all tangible items comprising, bearing or containing any such Confidential Information and provide a written certification of such destruction; provided, however, that each Party may retain one (1) copy of such Confidential Information for archival purposes and for ensuring compliance with this Article 9.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


9.8 Use of Performance Data. Notwithstanding anything to the contrary contained in this Agreement, Licensee agrees that Licensor may use redacted cell line performance data for cell lines produced for Licensee hereunder for the purposes of marketing the Potelligent CHOK1SV Technology. The Parties shall use the mechanism set forth in Section 9.5 for the review and clearance of any such redacted cell line performance data.

ARTICLE 10 -

REPRESENTATIONS, WARRANTIES AND COVENANTS

10.1 Mutual Representations, Warranties and Covenants. Licensor and Licensee each warrants, represents and covenants to the other that:

10.1.1 Organization. It is duly organized and validly existing under the laws of its jurisdiction of incorporation, and has full corporate power and authority to enter into this Agreement and to perform its obligations hereunder;

10.1.2 Authority. This Agreement has been duly authorized, executed and delivered by such Party and constitutes valid and binding obligations of such Party, enforceable in accordance with their respective terms, subject to applicable bankruptcy, insolvency, reorganization, and other laws of general application limiting the enforcement of creditors’ rights;

10.1.3 Consents and Approvals. Such Party has obtained all necessary consents, approvals and authorizations of all governmental authorities and Third Parties required to be obtained by such Party in connection with the execution of this Agreement;

10.1.4 No Conflicts. The execution, delivery and performance of this Agreement does not conflict with, or constitute a breach or default under any of the charter or organizational documents of such Party, any law, order, judgment or governmental rule or regulation applicable to such Party, or any material agreement, contract, commitment or instrument to which such Party is a party.

10.1.5 Assignment of IP Rights . Each employee, consultant, agent or Sublicensee of such Party performing work under this Agreement has, and during the Term will have, a legally binding and outstanding obligation to assign the rights of such employee, consultant, agent or Sublicensee to any Improvements to such Party.

10.2 Licensor’s Representations, Warranties and Covenants. Licensor represents, warrants and covenants to Licensee that (i) it has the right to grant the rights and licenses granted herein [***], (ii) [***] in the performance of this Agreement, or the exercise of any rights obtained hereunder, Licensor will comply with all applicable laws, regulations, rules, orders and other requirements, now or hereafter in effect, [***].

10.3 Licensee’s Representations, Warranties and Covenants . Licensee represents, warrants and covenants to Licensor that in the performance of this Agreement, or the exercise of any rights obtained hereunder, Licensee will comply with and will cause its Affiliates and Sublicensees to comply with, all applicable laws, regulations, rules, orders and other requirements, now or hereafter in effect.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


10.4 DISCLAIMER OF WARRANTIES . EXCEPT AS SET FORTH IN THIS AGREEMENT, LICENSOR AND LICENSEE MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED (IN THE CASE OF LICENSOR, INCLUDING WITH RESPECT TO THE TECHNOLOGY), INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF THE PATENTS LICENSED HEREUNDER, OR NONINFRINGEMENT OF THE IP RIGHTS OF THIRD PARTIES. IN PARTICULAR, LICENSOR OFFERS NO REPRESENTATION OR WARRANTIES THAT THE USE OF ALL OR ANY PART OF THE TECHNOLOGY WILL RESULT IN THE SUCCESSFUL COMMERCIALIZATION OF ANY PRODUCT FOR ANY PURPOSE.

10.5 MATERIALS DISCLAIMER . THE TRANSFECTION SUPPLEMENTS, VECTORS AND POTELLIGENT ® CHOK1SV TRANSFERRED PURSUANT TO THIS AGREEMENT, WHEN COMBINED WITH AN ANTIBODY, ARE IN THE DEVELOPMENTAL STAGE AND MAY HAVE HAZARDOUS PROPERTIES. THE VECTORS, TRANSFECTION SUPPLEMENTS AND POTELLIGENT ® CHOK1SV ARE UNTESTED AND, EXCEPT AS SET FORTH IN THIS AGREEMENT, PROVIDED “AS IS” WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. LICENSEE SHALL BEAR ALL RISK RELATING TO THE VECTORS, POTELLIGENT ® CHOK1SV, AND TRANSFECTION SUPPLEMENTS TRANSFERRED TO LICENSEE, AND LICENSOR SHALL NOT BE LIABLE UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY FOR ANY DAMAGES INCLUDING DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR COST OF PROCUREMENT OF SUBSTITUTE GOODS, SERVICES OR TECHNOLOGY IN CONNECTION THEREWITH.

10.6 IP DISCLAIMER . EXCEPT AS OTHERWISE EXPLICITLY PROVIDED IN THIS AGREEMENT, NOTHING IN THIS AGREEMENT IS OR SHALL BE CONSTRUED AS: (i) A WARRANTY OR REPRESENTATION BY LICENSOR AS TO THE VALIDITY, ENFORCEABILITY OR SCOPE OF ANY CLAIM WITHIN LICENSOR IP RIGHTS; (ii) A WARRANTY OR REPRESENTATION THAT ANYTHING MADE, USED, OFFERED FOR SALE, SOLD OR OTHERWISE DISPOSED OF UNDER ANY LICENSE GRANTED IN THIS AGREEMENT IS OR SHALL BE FREE FROM INFRINGEMENT OF ANY PATENT RIGHTS OR OTHER IP RIGHT OF A THIRD PARTY; (iii) AN OBLIGATION TO BRING OR PROSECUTE ACTIONS OR SUITS AGAINST THIRD PARTIES FOR INFRINGEMENT OF ANY OF THE LICENSOR IP RIGHTS; OR (iv) GRANTING BY IMPLICATION, ESTOPPEL, OR OTHERWISE ANY LICENSES OR RIGHTS UNDER IP RIGHTS OF LICENSEE OR LICENSOR OR THIRD PARTIES, REGARDLESS OF WHETHER SUCH IP OR OTHER RIGHTS ARE DOMINANT OR SUBORDINATE TO ANY LICENSOR IP RIGHTS.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


ARTICLE 11 -

INDEMNIFICATION

11.1 Indemnification by Licensee . Licensee shall defend, indemnify and hold harmless Licensor, its Affiliates, and their respective directors, officers, employees and agents from all claims, losses, damages and expenses, including reasonable legal expenses (“Losses”), each to the extent payable to a Third Party, resulting from suits, claims, actions, demands or other proceedings, in each case brought by a Third Party (“Claims”) to the extent arising out of or relating to (i) the gross negligence, unlawful act or willful misconduct of Licensee (including its Affiliates and Sublicensees) in connection with its or their performance of this Agreement; or (ii) the making, having made, distribution, sale, offer for sale or use of any Antibody or Product or the use of Licensor IP Rights or the Technology by Licensee or its Sublicensees, except to the extent that such Losses are a direct result of Licensor’s gross negligence, willful misconduct or unlawful act or its breach of any covenant, representation or warranty made by it in this Agreement.

11.2 [***] .

11.3 Procedure. The following provisions are conditions on each Party’s indemnification obligations hereunder. If either Party intends to claim indemnification under this Article 11, it shall promptly notify the other Party (the “Indemnitor”) in writing of any Claims of a Third Party for which it (the “Indemnitee”) intends to claim such indemnification. Indemnitor shall have sole control of the defense and settlement of any such Claim, provided that Indemnitee shall have the right to participate in, and, to the extent Indemnitor so desires, to assume the defense thereof with counsel mutually satisfactory to the Parties. The obligations of this Article 11 shall not apply to amounts paid in settlement of any Claims of Third Party if such settlement is effected without the consent of Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve Indemnitor of any obligation to Indemnitee under this Article 11. Indemnitee, its or their employees and agents, shall reasonably cooperate with Indemnitor and its legal representatives in the investigation of any Claim covered by this Article 11.

11.4 Insurance Proceeds. Any indemnification hereunder shall be made net of any insurance proceeds recovered by the Indemnitee; provided, however, that if, following the payment to the Indemnitee of any amount under this Article 11, such Indemnitee recovers any insurance proceeds in respect of the Claim for which such indemnification payment was made, the Indemnitee shall promptly pay an amount equal to the amount of such proceeds (but not exceeding the amount of such indemnification payment) to the Indemnitor .

11.5 Insurance. Each Party shall procure and maintain insurance policies underwritten by a reputable insurance company or self-insurance, including clinical trial and product liability insurance, and providing adequate coverage for its respective obligations and activities hereunder. Notwithstanding the foregoing, Licensee and its Affiliates shall procure and/or maintain policies of insurance for comprehensive general liability, clinical trials and products liability coverage in a minimum amount of [***] with respect to Licensee’s performance under this Agreement.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


11.6 Limitation of Liability . LICENSOR SHALL NOT BE LIABLE TO LICENSEE AND LICENSEE SHALL NOT BE LIABLE TO LICENSOR FOR ANY CONSEQUENTIAL, INCIDENTAL, PUNITIVE, SPECIAL OR INDIRECT DAMAGES, INCLUDING LOSS OF ANTICIPATED PROFITS, EXCEPT TO THE EXTENT SUCH DAMAGES WERE CAUSED BY THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OR UNLAWFUL ACT OF THAT PARTY OR ITS AFFILIATES OR SUBLICENSEES. [***] ARISING OUT OF THIS AGREEMENT SHALL BE LIMITED TO THE AGGREGATE VALUE OF THE MONETARY CONSIDERATION ACTUALLY RECEIVED BY LICENSOR FROM LICENSEE UNDER THIS AGREEMENT.

ARTICLE 12 -

DISPUTE RESOLUTION

12.1 Dispute Resolution Philosophy and Process . Any dispute that may arise between Licensor and Licensee relating to the terms of this Agreement or the activities of the Parties shall be referred to (i) an officer of Licensee and (ii) an officer of each of Lonza and BioWa (collectively, the “Management Representatives”), who shall attempt in good faith to achieve a resolution. If such Management Representatives are unable to resolve such a dispute within sixty (60) Business Days of the first presentation of such dispute to such Management Representatives, such dispute shall be referred to an appropriately senior officer of each of Lonza and BioWa and the an appropriately senior officer of Licensee (or their respective designees) who shall use their good faith efforts to mutually agree upon the proper course of action to resolve the dispute. If any dispute is not resolved by these individuals (or their designees) within thirty (30) Business Days after such dispute is referred to them, or such longer period as they may mutually agree, then Licensee or Licensor shall have the right to pursue the dispute resolution mechanism provided in Section 12.2 following.

12.2 International Court of Arbitration. Any dispute that may arise between Licensor and Licensee relating to the terms of this Agreement or the activities of the Parties that is not resolved pursuant to Section 12.1 hereof shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (“ICC”). The arbitration will be held in New York City, New York before a single arbitrator knowledgeable in biotechnology-related matters and familiar with the biotechnology industry, selected in accordance with the rules and regulations of the ICC. The arbitration will be conducted in the English language and in accordance with the rules and regulations promulgated by the ICC, unless specifically modified in this Agreement. The arbitration must commence within sixty (60) days of the date on which the arbitrator is selected. The arbitrator will have the power to order the production of documents by each Party and any Third Party witnesses; however, the arbitrator will not have the power to order the taking of depositions, the answering of interrogatories or the responses to requests for admission. Each Party must provide to the other, no later than seven (7) business days before the date of arbitration, the identity of all persons that may testify at the arbitration and a copy of all documents that may be introduced at the arbitration or considered or used by a Party’s witness or expert. The arbitrator’s decision and award will be made and delivered as soon as reasonably possible and in any case

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


within six (6) months of the selection of the arbitrator. The arbitrator’s decision must set forth a reasoned basis for any award of damages or finding of liability. The arbitrator will not have power to award damages in excess of actual compensatory damages unless expressly authorized by this Agreement and may not multiply actual damages or award punitive damages or any other damages that are specifically excluded under this Agreement. The Parties covenant and agree that they will participate in the arbitration in good faith and that they will share equally the costs of the arbitration, except as otherwise provided herein. Any Party refusing to comply with an order of the arbitrator will be liable for costs and expenses, including attorneys’ fees, incurred by the other Parties in enforcing the award. Notwithstanding the foregoing to the contrary, in the case of temporary or preliminary injunctive relief, any party may proceed in court without prior arbitration for the purpose of avoiding immediate and irreparable harm. The provisions of this Section will be enforceable in any court of competent jurisdiction.

12.3 No Limitation . Notwithstanding the foregoing, nothing in this Agreement shall be construed as limiting in any way the right of a Party to immediately seek temporary and/or preliminary injunctive relief from a court of competent jurisdiction with respect to any actual or threatened breach of this Agreement.

ARTICLE 13 -

MISCELLANEOUS PROVISIONS

13.1 Advice of Counsel . Licensee and Licensor have consulted counsel of their choice regarding this Agreement and each acknowledges and agrees that this Agreement shall not be deemed to have been drafted by one Party or another and shall be construed accordingly.

 

  13.2 Assignment . Licensee shall not assign this Agreement without the prior written consent of Licensor, except that Licensee may assign this Agreement without consent to an Affiliate, or to a successor to all or substantially all of its business or assets. In order for an assignment under this provision to become effective, the permitted assignee shall confirm to Licensor in writing that it will assume all obligations of Licensee under this Agreement from the date of the assignment. No assignment shall relieve the assignor of its obligations which accrued prior to the date of assignment. If any permitted assignment by Licensee would result in withholding or other similar taxes becoming due on payments to Licensor under this Agreement, Licensee shall be responsible for all such taxes and the amount of such taxes shall not be withheld or otherwise deducted from the amounts payable to Licensor. If, in such event, Licensor actually reduces the amount of income tax paid by it as a result of using a credit for the amount of such withholding or similar taxes paid by the Licensee, then Licensor shall promptly refund to Licensee the amount of such reduction in income tax resulting from the use of such credit. [***].

13.3 Binding Effect . This Agreement, the rights granted and obligations assumed hereunder shall be binding upon and shall inure to the benefit of Licensee, Licensor and their respective successors and permitted assigns.

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


13.4 Counterparts . This Agreement may be executed in counterparts, or facsimile versions, each of which shall be deemed to be an original, and all of which together shall be deemed to be one and the same agreement.

13.5 Entire Agreement . This Agreement, the Third Party Reviewer Agreement, the 2008 License, the 2008 Letter Agreement, the Lonza License and the exhibits and schedules hereto and thereto, constitute and contain the entire understanding and agreement of the Parties respecting the subject matter hereof and thereof, and cancel and supersede any and all prior negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter.

13.6 Force Majeure . The failure of Licensor or Licensee to timely perform any obligation under this Agreement by reason of epidemic, earthquake, riot, civil commotion, fire, act of God, war, terrorist act, strike, flood, or governmental act or restriction, or other cause that is beyond the reasonable control of that Party shall not be deemed to be a material breach of this Agreement, but shall be excused to the extent and for the duration of such cause, and that Party shall provide the other Parties with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities) and shall use commercially reasonable efforts to avoid or remove such cause, and shall perform its obligation(s) with the utmost dispatch when the cause is removed. If the performance of any such obligation under this Agreement is delayed owing to such a force majeure for any continuous period of more than one hundred eighty (180) days, the Parties hereto shall consult with respect to an equitable solution, including the possibility of the mutual termination of this Agreement.

13.7 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments and to do all such other acts as may be reasonably necessary or appropriate in order to carry out the purposes and intent of this Agreement. The Parties shall cooperate and use commercially reasonable efforts to make all other registrations, filings, and applications, to give all notices, and to obtain as soon as practicable all governmental or other consents, transfers, approvals, orders, qualifications, authorizations, permits, and waivers, if any, and to do all other things necessary or desirable for the consummation of this Agreement.

13.8 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the application of principles of conflicts of law.

13.9 Interpretation. The captions and headings in this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the particular Articles, Sections or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto. Unless the context otherwise clearly requires, whenever used in this Agreement: (i) the words “include” or “including” shall be construed to have the inclusive meaning frequently identified with the phrase “including but not limited to” or “including without limitation;” (ii) the word “day” or “year” means a calendar day or year; (iii) the word “notice” shall mean notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


communications contemplated under this Agreement; (iv) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits); (v) the word “or” shall be construed to have the inclusive meaning identified with the phrase “and/or;”(vi) words of any gender include the other gender; (vii) references to the plural shall be deemed to include the singular and the plural, the part and the whole; and (viii) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement law, rule or regulation thereof.

13.10 No Implied Licenses to Use of Name or Trademark . Except as otherwise specifically provided in Section 8.5, no right, expressed or implied, is granted by this Agreement to a Party to use in any manner the name or any other trademark of any other Party in connection with the performance of this Agreement.

13.11 Independent Contractors . Each Party is an independent contractor under this Agreement. Nothing contained in this Agreement is intended nor is to be construed so as to constitute Licensee or Licensor as partners or joint venturers with respect to this Agreement. No Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of any other Party, or to bind any other Party to any other contract, agreement or undertaking with any Third Party or Affiliate.

13.12 Notices and Deliveries . Any formal notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing in English and shall be deemed to have been sufficiently given when it is received, whether delivered in person, transmitted by facsimile with contemporaneous confirmation by mail, delivered by certified mail (or its equivalent), or delivered by courier service (receipt required), to the Party to which it is directed at its address shown below or such other address as such Party shall have last given by notice to the other Parties.

 

If to Licensor:    With a copy to:
BioWa, Inc.    Alfred W. Zaher, Esq.
212 Carnegie Center, Suite 101    Blank Rome LLP
Princeton NJ 08540, USA    130 North 18 th Street
Attn: Masamichi Koike, Ph.D., President and CEO    Philadelphia, PA 19103
Tel: 1 (609) 580-7500    United States of America
Fax: 1 (609) 580-7534    Fax: 1 (215) 832-5364
And    With a copy to:
Lonza Sales AG    Lonza Biologics Plc
Munchensteinerstrasse 38    228 Bath Road
Basel    Slough, SL1 4DX
CH-4002, Switzerland    United Kingdom
Attn: General Counsel    Attn: Company Secretary
Fax: +41 61 316 91 11    Fax: +44 1753 777 001

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


If to Licensee:    With a copy to:
Kalobios Pharmaceuticals, Inc.    Gunderson Dettmer et al.
260 East Grand Avenue    1200 Seaport Boulevard
South San Francisco, CA 94080    Redwood City, CA 94063
Attention: Legal    Attention: Colin D. Chapman, Esq,

13.13 Severability . If any provision of this Agreement becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, this Agreement shall continue in full force and effect without said provision, so long as the Agreement, taking into account said voided provision, continues to provide the Parties with materially the same benefits as set forth in this Agreement on the Effective Date. If, after taking into account said voided provision, the Parties are unable to realize materially the same, the Parties shall negotiate in good faith to amend this Agreement to reestablish (to the extent legally permissible) the benefits as provided the Parties under this Agreement on the Effective Date.

13.14 Waiver . No waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party. The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition.

13.15 Exhibits . The exhibits attached to this Agreement shall form an integral part hereof. In the event of any inconsistency between this Agreement and any exhibit, this Agreement shall prevail.

13.16 Section 365(n) of the Bankruptcy Code . All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective rights and elections under section 365(n) of the Bankruptcy Code.

(signature page follows)

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


IN WITNESS WHEREOF , the Parties have put their names and affixed their seals or executed this Agreement and each Party shall have one (1) copy.

 

LONZA SALES AG     BIOWA, INC.
By:         By:    
Name:       Name:  
Title:       Title:  
LONZA SALES AG      
By:          
Name:        
Title:        
KALOBIOS PHARMACEUTICALS, INC.      
By:          
Name:        
Title:        

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT 1

LICENSOR PATENT RIGHTS

 

KHK ID

  

Title

   Country    Application No.    Publication No.    Filing Date
(y/m/d)
   Patent No.    Issue Date
[***]    [***]    [***]    [***]    [***]    [***]      
      [***]    [***]       [***]      
      [***]    [***]       [***]      
      [***]    [***]    [***]    [***]      
      [***]    [***]    [***]    [***]      
      [***]    [***]       [***]    [***]    [***]
      [***]    [***]    [***]    [***]      
      [***]    [***]    [***]    [***]      
      [***]    [***]    [***]    [***]    [***]    [***]
      [***]    [***]    [***]    [***]    [***]    [***]
      [***]    [***]       [***]      
[***]    [***]    [***]    [***]    [***]    [***]      
      [***]    [***]       [***]    [***]    [***]
      [***]    [***]       [***]      
      [***]    [***]       [***]      
      [***]    [***]       [***]      
      [***]    [***]    [***]    [***]      
      [***]    [***]       [***]    [***]    [***]
      [***]    [***]       [***]    [***]    [***]
      [***]    [***]    [***]    [***]      
      [***]    [***]    [***]    [***]      
      [***]    [***]       [***]      
      [***]    [***]       2001/10/5    [***]    [***]
      [***]    [***]       [***]    [***]    [***]
      [***]    [***]    [***]    [***]      
      [***]    [***]    [***]    [***]      
      [***]    [***]       [***]    [***]    [***]
      [***]    [***]       [***]      
      [***]    [***]       [***]      
      [***]    [***]       [***]    [***]    [***]
      [***]    [***]    [***]    [***]    [***]    [***]
      [***]    [***]    [***]    [***]    [***]    [***]
      [***]    [***]    [***]    [***]    [***]    [***]
      [***]    [***]    [***]    [***]      
   [***]    [***]    [***]       [***]    [***]    [***]
      [***]    [***]       [***]    [***]    [***]
   [***]    [***]    [***]       [***]    [***]    [***]
   [***]    [***]    [***]       [***]    [***]    [***]
   [***]    [***]    [***]       [***]    [***]    [***]

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT 2

[***]

[***]

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


Schedule 1

[***]

[***]

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT 3

[***]

[***]

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION


EXHIBIT 4

[***]

[***]

 

[***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND FILED SEPARATELY WITH THE COMMISSION