License And Collaborative Research Agreement

EXHIBIT 10.03


CORIXA CORPORATION


AND


JAPAN TOBACCO INC.


LICENSE


AND


COLLABORATIVE RESEARCH


AGREEMENT


2


TABLE OF CONTENTS


1. DEFINITIONS............................................................................1


2. SCOPE OF RESEARCH PROGRAM; CLINICAL DEVELOPMENT PROGRAM................................5


3. RESEARCH PROGRAM TERM AND TERMINATION..................................................5


4. STEERING COMMITTEES....................................................................6


5. LICENSE GRANTS; OPTION; RIGHTS OF FIRST REFUSAL........................................7


6. PAYMENTS...............................................................................8


7. ROYALTY PAYMENTS.......................................................................9


8. REPORTS, PAYMENTS AND ACCOUNTING......................................................10


9. COMMERCIAL DEVELOPMENT................................................................12


10. MANUFACTURING; SUPPLY.................................................................12


11. INVENTIONS............................................................................13


12. PATENTS; PROSECUTION AND LITIGATION...................................................13


13. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS..............................................14


14. GOVERNING LAW; ARBITRATION............................................................15


15. MISCELLANEOUS.........................................................................15


16. NOTICES...............................................................................16


17. ASSIGNMENT............................................................................17


18. WARRANTIES, REPRESENTATIONS AND COVENANTS.............................................17


19. TERM AND TERMINATION..................................................................19


20. RIGHTS AND DUTIES UPON TERMINATION....................................................19


21. INDEMNIFICATION.......................................................................20


22. GOVERNMENTAL CONSENT..................................................................21


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EXHIBITS


Exhibit A Corixa Patents


Exhibit A-1 Corixa Adjuvant Patents


Exhibit A-2 Microsphere Patents


Exhibit B Research Program


Exhibit C List of Third Party Agreements


Exhibit D Form of Supply Agreement


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LICENSE AND COLLABORATIVE RESEARCH AGREEMENT


This LICENSE AND COLLABORATIVE RESEARCH AGREEMENT (together with the attachments and exhibits hereto, the "Agreement") is entered into as of June 15, 1999 (the "Execution Date") by and between Corixa Corporation, a corporation organized and existing under the laws of the State of Delaware and having its principal office at 1124 Columbia Street, Suite 200, Seattle, Washington, and Japan Tobacco Inc., a corporation organized and existing under the laws of Japan and having its principal office at 2-2-1 Toranomon, Minato-ku, Tokyo 105-8422, Japan.


RECITALS


WHEREAS, Corixa has scientific expertise, proprietary information and biological materials related to antigen discovery and vaccine development;


WHEREAS, JT has expertise in developing and commercializing therapeutic products;


WHEREAS, Corixa and JT desire to collaborate in the development of vaccine products for the treatment of lung cancer, which vaccines will contain certain [***]* antigens [***]*; and


WHEREAS, Corixa has agreed to license to JT in certain territories certain intellectual property rights related to the Collaboration, including discoveries to be made during the Collaboration, subject to the terms and conditions of this Agreement.


NOW, THEREFORE, for and in consideration of the mutual observance of the covenants hereinafter set forth and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:


1. DEFINITIONS.


All references to particular Exhibits, Articles and Sections shall mean the Exhibits to, and Articles and Sections of, this Agreement, unless otherwise specified. References to this "Agreement" include the Exhibits. For the purposes of this Agreement, the following words and phrases shall have the following meanings:


1.1 "Additional Lung Cancer License Agreement" shall have the meaning set forth in Section 5.3.


1.2 "Additional Technology" shall have the meaning set forth in Section 5.1(f).


1.3 "Affiliate" of an entity means, for so long as one of the following relationships is maintained, any corporation or other business entity owned by, owning, or under common ownership with a party to this Agreement to the extent of at least fifty percent (50%) of the equity (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a


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particular jurisdiction) having the power to vote on or direct the affairs of the entity and any person, firm, partnership, corporation, or other entity actually controlled by, controlling or under common control with a party to this Agreement. Notwithstanding the foregoing, the government of Japan shall not be considered an Affiliate of JT for purposes of this Agreement.


1.4 "Antibody" shall mean [***]*.


1.5 "Antigen(s)" shall mean any antigen [***]* covered by one (1) or more claim(s) of any of the Corixa Patents and/or the Joint Research Patents.


1.6 "Asia" shall mean [***]*


1.7 "Clinical Development Program" shall have the meaning set forth in Section 2.3.


1.8 "Co-Development Committee" shall have the meaning set forth in Section 9.2.


1.9 "Collaboration" means the joint collaboration of Corixa and JT pursuant to the terms of this Agreement, the Research Program and the Clinical Development Program.


1.10 "Completion" shall have the meaning set forth in Section 6.3.


1.11 "Corixa" shall mean Corixa Corporation and each of its Affiliates.


1.12 "Corixa Adjuvant" shall mean the protein Leishmania Elongation Initiation Factor, known as LeIF, [***]* covered by one (1) or more of claim(s) of any of the Corixa Patents that are identified on Exhibit A-1, as may be amended from time to time.


1.13 "Corixa Patents" shall mean (a) all [***]*. Corixa Patents shall specifically not include either JT Patents or Joint Research Program Patents.


1.14 "Development Steering Committee" shall have the meaning set forth in Section 4.1(b).


1.15 "Development Period" shall mean the period commencing upon the end of the Research Program Term and ending upon [***]*.


1.16 "Effective Date" shall have the meaning set forth in Section 22.2.


1.17 "Europe" shall mean [***]*.


1.18 "European Partner" shall have the meaning set forth in Section 5.3.


1.19 "FTE" shall mean [***]* for individual Corixa scientific employees assigned to perform the Research Program, or its equivalent if a given employee is assigned on a part-time basis and therefore multiple employees are added to provide a single FTE.


1.20 "FTE Rate" shall have the meaning set forth in Section 2.1.


1.21 "Fully Burdened Manufacturing Cost" shall mean [***]*.


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1.22 "GAAP" or "U.S. generally accepted accounting principles" shall mean the conventions, rules and procedures governing accounting practices as established, and revised or amended, by the U.S. Financial Accounting Standards Board or the U.S. Securities and Exchange Commission.


1.23 [***]*


1.24 "IND" shall have the meaning set forth in Section 4.1(a).


1.25 "Joint Research Program Patents" shall mean all [***]*. In no event shall Joint Research Program Patents be deemed to include Corixa Patents or JT Patents.


1.26 "Joint Inventions" shall have the meaning set forth in Section 11.


1.27 "JT" shall mean Japan Tobacco Inc. and each of its Affiliates.


1.28 "JT Patents" shall mean [***]*. In no event shall JT Patents be deemed to include either Corixa Patents or Joint Research Program Patents.


1.29 "Know-How" shall mean all [***]*.


1.30 "Licensed Antibody Product" shall mean any [***]*. For purposes of clarity, "Licensed Antibody Product" shall refer to and mean Licensed Corixa Antibody Product and/or Licensed JT Antibody Product, as the case may be.


1.31 "Licensed Corixa Antibody Product" shall mean any Licensed Antibody Product that [***]*.


1.32 "Licensed Field" shall mean [***]*.


1.33 "Licensed JT Antibody Product" shall mean any Licensed Antibody Product that [***]*.


1.34 "Licensed Product" shall mean any and all Licensed Antibody Products and Licensed Vaccine Products.


1.35 "Licensed Vaccine Product" shall mean any [***]*.


1.36 "Microspheres" shall mean the encapsulated antigen delivery system [***]* covered by one (1) or more claim(s) of any of the Corixa Patents that are identified on Exhibit A-2.


1.37 "Net Sales" shall mean the amount [***]* to a Third Party of a Licensed Product, less the following deductions for amounts actually incurred related to such sale or other disposition: [***]*.


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1.38 "North America" shall mean [***]*.


1.39 "Patent Steering Committee" shall have the meaning set forth in Section 4.1(c).


1.40 "Research Field" shall mean lung cancer in humans.


1.41 "Research Steering Committee Period" shall have the meaning set forth in Section 4.1(a).


1.42 "Research Program" shall have the meaning set forth in Section 2.1.


1.43 "Research Program Term" shall have the meaning set forth in Section 3.1.


1.44 "Research Steering Committee" shall have the meaning set forth in Section 4.1.


1.45 "Rest of World" shall mean worldwide, except for [***]*.


1.46 "Selected Antigen(s)" shall have the meaning set forth in Section 3.3.


1.47 "SPC" shall mean all Supplementary Protection Certificates for any medicinal Licensed Product and its equivalents provided under the Council Regulation (EEC) N# 1768/92 of June 18, 1992 or any succeeding regulation thereto.


1.48 "Territory A" shall mean Asia, North America and Rest of World.


1.49 "Territory B" shall mean [***]* China and its territories, possessions and protectorates, [***]*.


1.50 "Third Party(ies)" shall mean any party other than a party to this Agreement or an Affiliate.


1.51 "Vaccine" shall mean the administration of (an) antigen(s) [***]*.


1.52 "Valid Claim" shall mean, with respect to each country in the territory, a claim of [***]*.


1.53 Interpretive Rules. For purposes of this Agreement, except as otherwise expressly provided herein or unless the context otherwise requires: (a) defined terms include the plural as well as the singular (and vice versa) and the use of any gender shall be deemed to include the other gender; (b) references to "Articles," "Sections" and other subdivisions and to "Schedules" and "Exhibits" without reference to a document, are to designated Articles, Sections and other subdivisions of, and to Schedules and Exhibits to, this Agreement; (c) unless otherwise set forth herein, the use of the term "including" means "including but not limited to"; and (d) the words


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"herein," "hereof," "hereunder" and other words of similar import refer to this Agreement as a whole and not to any particular provision.


2. SCOPE OF RESEARCH PROGRAM; CLINICAL DEVELOPMENT PROGRAM.


2.1 During the Research Program Term, the parties shall collaborate in the development of [***]*. The program of activities to be conducted by Corixa during the term of the Agreement is set forth on Exhibit B (the "Research Program"), [***]*. Corixa and JT agree that during the first and second years of the initial Research Program Term [***]*. During the third year of the initial Research Program Term, Corixa and JT agree that [***]*.


2.2 In the event JT desires during the Research Program Term as may be extended to [***]*.


2.3 Subsequent to [***]* (hereinafter the "Clinical Development Program" with respect to such Licensed Product(s)). The parties agree that the end goal of the Clinical Development Program is [***]*.


2.4 During the Research Program Term as may be extended, [***]*.


2.5 The parties acknowledge and agree that nothing in this Agreement shall restrict in any manner Corixa's ability to [***]*.


3. RESEARCH PROGRAM TERM AND TERMINATION.


3.1 The initial period of time during which the Research Program shall be performed shall commence on the Effective Date and terminate on the [***]* anniversary of the Effective Date, subject to extension as set forth in Section 3.2 (the "Research Program Term"); provided, however, that the Research Program Term shall terminate upon any termination of this Agreement in accordance with Sections 19.3(b), 19.6 or 19.7.


3.2 Upon the mutual written agreement of the parties, the Research Program Term shall be extended for one or more additional period(s) beyond the termination date of its initial term or any subsequent extension period, provided the such agreement is reached no later than [***]* prior to the expiration of such initial term or subsequent extension period. In the event of such a mutually agreed extension, the parties shall [***]*. With respect to any such extension of the Research Program Term pursuant to this Section 3.2, Corixa and JT shall [***]*.


3.3 Prior to the termination of the Research Program Term, JT shall have the right to notify Corixa in writing of [***]*.


4. STEERING COMMITTEES.


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4.1 (a) A Research Steering Committee (the "Research Steering Committee") shall be established within [***]* after the full execution of this Agreement. During the period beginning on the Effective Date and ending on [***]* (the "Research Steering Committee Period"), the Research Steering Committee shall consist of [***]*. During the Research Steering Committee Period, the Research Steering Committee shall be responsible for [***]*.


(b) Following the Research Steering Committee Period and until [***]* (the "Development Steering Committee") shall be established. The Development Steering Committee shall consist of [***]*. The Development Steering Committee shall be responsible for [***]*.


(c) Additionally, a Patent Steering Committee (the "Patent Steering Committee") shall be established within [***]* after the full execution of this Agreement. The Patent Steering Committee shall operate during the term of this Agreement and shall be responsible for all patent-related activities pursuant to this Agreement. The Patent Steering Committee shall consist of [***]*.


4.2 To facilitate coordination during the Research Steering Committee Period, the parties shall share [***]*. Corixa shall provide JT with [***]* on the progress of the Research Program and, [***]*. All such [***]* shall be subject to the confidentiality provisions of Section 13 of this Agreement. The Research Steering Committee shall review the Research Program [***]*. All actions by the Research Steering Committee shall require [***]*.


4.3 The Development Steering Committee shall meet [***]*. To facilitate coordination during and subsequent to the Development Period, the parties shall [***]*. JT shall provide Corixa with [***]* on the progress of the Clinical Development Program, including [***]*. All such [***]* shall be, [***]* subject to the confidentiality provisions of Section 13 of this Agreement. Additionally, [***]*. All actions by the Development Steering Committee shall require the [***]*.


4.4 After [***]*, the Development Steering Committee shall [***]*. In conjunction with the foregoing meetings, JT shall provide Corixa with [***]* commercialization, including [***]*. All such information shall be subject to the confidentiality provisions of Section 13 of this Agreement. [***]*


4.5 The Patent Steering Committee shall meet regularly [***]*. To facilitate the coordination and monitoring of patent-related activities hereunder, the Patent Steering Committee shall [***]*. The Patent Steering Committee shall [***]*. All such [***]* shall be subject to the confidentiality provisions of Section 13 of this Agreement. All actions by the Patent Steering Committee shall require [***]*, provided that all such actions shall be subject to the procedures and responsibilities set forth in Section 12. [***]*.


5. LICENSE GRANTS; [***]* .


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5.1 License.


(a) Subject to the terms and conditions of this Agreement, including, without limitation, Section 3.3 and the payments set forth in Section 6 hereof, Corixa hereby grants to JT an exclusive license, [***]* Licensed Vaccine Products and Licensed Corixa Antibody Products solely in the Licensed Field in Territory A.


(b) Subject to the terms and conditions of this Agreement, including, without limitation, Section 3.3, Section 5.3 and the payments set forth in Section 6 hereof, Corixa hereby grants to JT a co-exclusive license [***]* Licensed Vaccine Products and Licensed Corixa Antibody Products solely in the Licensed Field in Territory B.


(c) Subject to the terms and conditions of this Agreement, including, without limitation, Section 3.3 and the payments set forth in Section 6 hereof, Corixa hereby grants to JT (i) a worldwide co-exclusive license [***]* Licensed JT Antibody Products solely for use in the Licensed Field and (ii) [***]*.


(d) Subject to the terms and conditions of this Agreement, Corixa hereby grants to JT a [***]* non-exclusive license, [***]*, to use Corixa Adjuvant and Microspheres solely for research purposes for evaluation [***]*. JT may [***]* confidential information under Section 13 hereof. [***]*. Subject to the terms and conditions of this Agreement, including, without limitation, the payments set forth in Section 6 hereof, Corixa hereby grants to JT a non-exclusive option, [***]* to obtain a non-exclusive license, [***]* Microspheres or Corixa Adjuvant in the Licensed Field in Territory A and B, [***]*.


(e) In the event that Corixa and JT shall have mutually agreed to the terms and conditions of [***]*.


(f) During the Research Program Term, [***]*.


(g) [***]*


(h) [***]*


5.2 Sublicenses of Third Party Rights to JT. JT understands and agrees that in the event it exercises the option to license Microspheres granted to it under Section 5.1(d) of this Agreement, such license shall include sublicenses by Corixa under agreements between Corixa and certain Third Parties. Exhibit C includes a list of agreements pursuant to which Third Party rights related to Microspheres are licensed to Corixa as of the Effective Date. JT understands and agrees that such sublicenses or licenses may in some respects be more restrictive than the terms and conditions of this Agreement or may require payments in addition to those set forth herein and agrees to abide by all applicable terms and conditions of such agreements.


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5.3 [***]*


5.4 [***]*


5.5 [***]*


5.6 [***]*


6. PAYMENTS.


Subject to Section 7.8, JT shall make the following payments to Corixa under this Agreement in U.S. Dollars by wire transfer of immediately available funds:


6.1 [***]* Funding. In addition to the [***]* funding set forth in Section 6.2, the [***]* amount of [***]* for [***]*. The full amount of this [***]* funding shall be [***]* paid directly to Corixa.


6.2 [***]* Funding. [***]* payments in the following amounts and [***]* dates set forth below, it being acknowledged and agreed each such payment shall be [***]*:


-------------------------------------- ---------------------
PAYMENT AMOUNT
PAYMENT DATE (U.S.$)
-------------------------------------- ---------------------
[***]* [***]*
-------------------------------------- ---------------------


The payment amounts set forth in the above table shall be [***]* paid directly to Corixa. The Research Program and corresponding payments, may be extended or expanded as set forth in Section 2.2 and Section 3.2 above. [***]*


6.3 Milestone Payments. In addition to the amounts payable pursuant to Sections 6.1 and 6.2 above, JT also agrees to pay Corixa the following milestone payments, to be made via wire transfer of immediately available funds, [***]*:


-------------------------------------------------- -------------------------
MILESTONE PAYMENT (U.S.$)
-------------------------------------------------- -------------------------
[***]* [***]*
-------------------------------------------------- -------------------------


For purposes of the above milestones [***]*.


6.4 [***]*


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7. ROYALTY PAYMENTS.


7.1 Royalties for Licensed Vaccine Products.


[***]*


7.2 Royalties for Licensed Antibody Products.


[***]*


7.3 Royalties for [***]*.


(a) For Licensed Vaccine Products that [***]*.


(b) For Licensed Vaccine Products that [***]*.


(c) For Licensed Vaccine Products that [***]*.


7.4 [***]*


7.5 [***]*


7.6 Royalty Term; [***]*. Royalties shall be earned and paid to Corixa until [***]*.


7.7 Currency. All amounts payable to Corixa under this Agreement shall be payable in United States Dollars, by wire transfer of immediately available funds to a bank account designated by Corixa, at Corixa's option. Monthly sales amounts shall be translated from Japanese Yen to U.S. Dollars by using an average rate of exchange. This average shall be computed using the rate of exchange quoted under Foreign Exchange in the Wall Street Journal as of the end of the current month plus the rate as of the end of the prior month and dividing by two (2). With respect to sales made by sublicensees (either Affiliates or Third Parties) of Japan Tobacco Inc., sales amounts will be converted from any foreign currencies to Japanese Yen using average rates of exchange published by the Bank of Tokyo-Mitsubishi in accordance with JT's standard methodology, consistently applied.


7.8 Withholding Taxes. If any law or regulation in any country requires the withholding by JT or its sublicensees of any taxes due on payments to be remitted to Corixa under this Agreement, such taxes shall be deducted from the amounts paid to Corixa. If the taxes are deducted from the amounts paid to Corixa, then JT or sublicensees shall furnish Corixa the originals of all official receipts for such taxes and such other evidence of such taxes and payment thereof as may be reasonably requested by Corixa and shall provide any reasonable assistance or cooperation which may be requested by Corixa in connection with any efforts by Corixa to obtain a credit for such taxes.


7.9 Currency Transfer Restrictions. If in any country payment or transfer of funds out of such country is prohibited by law or regulation, the parties hereto shall confer regarding the terms and conditions on which Licensed Products shall be sold in such countries, including the possibility of payment of royalties to Corixa in local currency to a bank account in such country or the renegotiation of royalties for such sales, and in the absence of any other agreement by the


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parties, such funds payable to Corixa shall be deposited in whatever currency is allowable by JT in an accredited bank in that country that is acceptable to Corixa.


7.10 Royalty Payments Upon Termination. If this Agreement is terminated in accordance with Section 19 with respect to all or some of the Licensed Products, JT shall continue to pay Corixa all amounts earned pursuant to this Section 7 prior to the date of termination and any amounts ea ...