LICENSE AGREEMENT

Amgen and Infinity Confidential

 

 

 

 

LICENSE AGREEMENT

BY AND BETWEEN

INFINITY PHARMACEUTICALS, INC.

AND

AMGEN INC.

 

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LICENSE AGREEMENT

THIS LICENSE AGREEMENT (the “Agreement”) dated the 7th day of July, 2006 (the “Effective Date”) is by and between INFINITY PHARMACEUTICALS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 780 Memorial Drive, Cambridge, Massachusetts 02139 (“Infinity”), and AMGEN INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at One Amgen Center Drive, Thousand Oaks, California 91320-1799 (“Amgen”).

INTRODUCTION

WHEREAS , Infinity and Amgen are each in the business of discovering, developing and commercializing pharmaceutical products.

WHEREAS , Infinity Controls certain technology for the creation of large numbers of complex, natural-compound-like compounds for the purpose of screening biological targets to identify potential human therapeutics.

WHEREAS , Infinity and Amgen entered into a Collaboration and License Agreement as of December 19, 2003 (the “Prior Agreement Effective Date”); such agreement, the “Prior Agreement”).

WHEREAS , Infinity and Amgen wish to extend and clarify certain rights under the Prior Agreement on the terms and conditions herein.

WHEREAS , Infinity and Amgen agree that after the Effective Date Infinity has [**] of the Prior Agreement and had [**] of the Prior Agreement.

NOW, THEREFORE , Infinity and Amgen agree as follows:

ARTICLE 1

DEFINITIONS

When used in this Agreement, each of the following terms shall have the meanings set forth in this Article 1:

Section 1.1 Affiliate . “Affiliate” shall mean any corporation, company, partnership, joint venture and/or firm that controls, is controlled by, or is under common control with a specified person or entity. For purposes of this Section 1.1, “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 more than 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 more than 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 outside of the United States, the maximum percentage ownership permitted by Law for a foreign investor may be less than fifty percent

 

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(50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such owner has the power to direct the management and policies of such entity.

Section 1.2 Amgen Analog . “Amgen Analog” shall mean an Analog that is designed, discovered or synthesized by Amgen in the course of a Drug Discovery Program.

Section 1.3 Amgen Analog Information . “Amgen Analog Information” shall mean all all structural, process and other information generated by Amgen relating to an Analog.

Section 1.4 Omitted .

Section 1.5 Omitted .

Section 1.6 Amgen Target . “Amgen Target” shall mean a Target against which Amgen or an Amgen Affiliate screens a Library Compound or an Analog.

Section 1.7 Analog . “Analog” shall mean any compound that is derived by Amgen from a Library Compound. As used herein, a compound shall be deemed to have been “derived from” a Library Compound if it is a chemical modification to a Library Compound which: (a) [**], (b) [**], or (c) [**].

Section 1.8 Back-Up Library Compound . “Back-Up Library Compound” shall mean, with respect to a Library Compound for which Amgen exercises a Library Compound Exclusivity Option, each other Library Compound that (a) is structurally related to, and is to be directed to the same Amgen Target as, the relevant Library Compound for which Amgen exercises the Library Compound Exclusivity Option and (b) Amgen designates in accordance with Section 3.6.2.

Section 1.9 Business Day . “Business Day” shall mean a day other than a Saturday or Sunday or Federal holiday.

Section 1.10 Combined Term . “Combined Term” shall mean the period commencing on the Prior Agreement Effective Date and ending on the two (2) year anniversary of the Effective Date.

Section 1.11 Confidential Information . “Confidential Information” shall mean (a) the Enumerated Target Information, all Amgen Analog Information and Exclusive Library Compound Information (which, with respect to the Exclusive Library Compound Information, shall be deemed to be Amgen Confidential Information for as long as it is subject to the respective licenses granted under Sections 3.1), which shall be deemed to be Amgen Confidential Information (subject to the provisions of Section 2.2), (b) all information relating to Library Compounds (other than Exclusive Library Compounds) and, following the termination of the respective licenses granted under Sections 3.1, any Exclusive Library Compound Information, which shall be deemed to be Infinity Confidential Information, and (c) all other proprietary documents, technology, Know-How or other information (whether or not patentable) actually disclosed by one Party to the other pursuant to the Prior Agreement or this Agreement or created by Infinity for Amgen’s benefit pursuant to the Prior Agreement or this Agreement and marked as “confidential” or “proprietary” (or if disclosed orally, confirmed in writing within thirty (30) days thereafter).

 

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Section 1.12 Control or Controlled . “Control” or “Controlled” shall mean with respect to any (a) material, document, item of information, method, data or other Know-How or (b) intellectual property right, the possession (whether by ownership or license, other than by a license granted pursuant to the Prior Agreement or this Agreement) by a Party or its Affiliates of the ability to grant to the other Party access, ownership, a license and/or a sublicense as provided herein without violating the terms of any agreement or other arrangement with any Third Party entered into or existing as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, ownership, license, or sublicense.

Section 1.13 Development or Develop . “Development” or “Develop” shall mean, with respect to a compound, preclinical and clinical drug development activities, including, among other things: test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control procedure development and performance with respect to clinical materials, statistical analysis and report writing and clinical studies. When used as a verb, “Develop” means to engage in Development.

Section 1.14 Drug Discovery Program . “Drug Discovery Program” shall mean an Amgen research program commenced during the Combined Term, which is focused on researching and developing (a) a Library Compound directed to an Amgen Target, which Library Compound was confirmed by Amgen as a [**] or (b) [**] was derived from a Library Compound that was confirmed by Amgen as a [**].

Section 1.15 EMEA . “EMEA” shall mean the European Medicines Evaluation Agency, or a successor agency thereto.

Section 1.16 Enumerated Target Information . “Enumerated Target Information” shall mean the information related to the [**] provided by Amgen to Infinity pursuant to the Letter Agreement between the Parties dated October 21, 2005 [**].

Section 1.17 Exclusive Library Compound . “Exclusive Library Compound” shall mean each Library Compound with respect to which Amgen exercises the Library Compound Exclusivity Option, together with all Back-Up Library Compound(s) licensed to Amgen pursuant to Sections 3.1.4 and 3.6.1 in connection with such exercise by Amgen of the Library Compound Exclusivity Option by operation of Section 3.6.2.

Section 1.18 Exclusive Library Compound Information . “Exclusive Library Compound Information” shall mean all structural, process and other information relating to an Exclusive Library Compound provided by Infinity to Amgen pursuant to the Prior Agreement and all such information generated by Amgen. For the avoidance of doubt, Exclusive Library Compound Information includes [**] and [**] and [**] with respect to the relevant Exclusive Library Compound.

Section 1.19 Exclusive Library Compound Royalty-Bearing Product . “Exclusive Library Compound Royalty-Bearing Product” shall mean a Royalty-Bearing Product that contains an Exclusive Library Compound.

 

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Section 1.20 Exclusivity Option Term . “Exclusivity Option Term” shall mean the period commencing on the Effective Date and ending twelve (12) months after the end of the Combined Term.

Section 1.21 FDA . “FDA” shall mean the United States Food and Drug Administration, or a successor agency thereto.

Section 1.22 First Commercial Sale . “First Commercial Sale” shall mean, for each Royalty-Bearing Product, on a country-by-country basis, [**] of such Royalty-Bearing Product, to a Third Party by Amgen or its Affiliates or Sublicensees, in a country in the Territory [**] in such country. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.

Section 1.23 Omitted .

Section 1.24 Omitted .

Section 1.25 GAAP . “GAAP” shall mean United States generally accepted accounting principles.

Section 1.26 Good Laboratory Practices or GLP . “Good Laboratory Practices” or “GLP” shall mean 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 United States.

Section 1.27 Hit . “Hit” shall mean a [**] (a) that is confirmed as active against an Amgen Target, or (b) for which [**], which is [**]. For purposes of this Section 1.27, [**] shall mean that a [**] or [**] are [**].

Section 1.28 Omitted .

Section 1.29 Hit-To-Lead Chemistry Program . “Hit-To-Lead Chemistry Program” shall mean chemistry activities directed to the generation of one or more Analogs with the goal of generating [**].

Section 1.30 IND . “IND” shall mean (a) (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoing.

Section 1.31 Omitted .

Section 1.32 Infinity Intellectual Property . “Infinity Intellectual Property” shall mean Infinity Know-How and Infinity Patent Rights.

 

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Section 1.33 Infinity Know-How . “Infinity Know-How” shall mean Know-How Controlled by Infinity during the Combined Term, including without limitation Library Compound Information.

Section 1.34 Infinity Patent Rights . “Infinity Patent Rights” shall mean Patent Rights Controlled by Infinity.

Section 1.35 Omitted .

Section 1.36 Omitted .

Section 1.37 Know-How . “Know-How” shall mean any information and materials, whether proprietary or not and whether patentable or not, including without limitation ideas, concepts, formulas, methods, procedures, designs, compositions, plans, documents, data, inventions, discoveries, works of authorship, compounds and biological materials, but excluding any such information or materials disclosed in Patent Rights.

Section 1.38 Law or Laws . “Law” or “Laws” shall mean 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.

Section 1.39 Lead . “Lead” shall mean a Library Compound or an Analog which meets Amgen’s then current criteria for committing resources commensurate with its other lead optimization programs.

Section 1.40 Lead Optimization Program . “Lead Optimization Program” shall mean the formation by Amgen of a program to perform all activities directed to the optimization of a Lead for purposes of identifying a clinical candidate and filing an IND.

Section 1.41 Library Compound . “Library Compound” shall mean a compound that Infinity delivered pursuant to the Prior Agreement.

Section 1.42 Omitted .

Section 1.43 Library Compound Exclusivity Option . “Library Compound Exclusivity Option” shall mean Amgen’s option to obtain exclusive rights with respect to a Library Compound [**], if any, as further described in Section 3.6.

Section 1.44 Library Compound Information . “Library Compound Information” shall mean structural, process or other information relating to a Library Compound, which is Controlled by Infinity and was delivered to Amgen by Infinity pursuant to the Prior Agreement. For the avoidance of doubt, Library Compound Information includes [**].

Section 1.45 Library Compound Structure Information . “Library Compound Structure Information” shall mean documentation of the molecular formula and molecular structure of each Library Compound that is Controlled by Infinity and which Infinity delivered to Amgen pursuant to the Prior Agreement.

 

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Section 1.46 MHW . “MHW” shall mean the Japanese Ministry of Health and Welfare, or a successor agency thereto.

Section 1.47 Omitted .

Section 1.48 NDA . “NDA” shall mean (a) (i) a New Drug Application submitted to the FDA, or any successor application or procedure, and (ii) any foreign counterpart of such a New Drug Application, and (b) all supplements and amendments, including supplemental New Drug Applications (and any foreign counterparts) that may be filed with respect to the foregoing.

Section 1.49 Net Sales . “Net Sales” shall mean all amounts actually received by Amgen, its Affiliates or its Sublicensees from sales of a Royalty-Bearing Product by Amgen, its Affiliates and its Sublicensees, to Third Parties (but not including sales relating to transactions between or among Amgen, its Affiliates and/or its Sublicensees), less the following deductions to the extent specifically relating to sales of the Royalty-Bearing Product and provided that any such deduction shall be deducted only once:

(a) Credits and allowances (actually paid or allowed) including, but not limited to, prompt payment and volume discounts, price reductions and rebates, reasonable service allowances and reasonable brokers’ or agents’ commissions, whether in cash or trade;

(b) Sales and other taxes, duties or other governmental charges based on sales prices when included in gross sales, as adjusted for rebates or refunds, but not including taxes when assessed on income derived from such sales;

(c) Credits or allowances given or provided for rejection or return of, and for uncollectable amounts on, previously sold Royalty-Bearing Products or for rebates or retroactive price reductions including, but not limited to, chargebacks from customers or wholesalers, other allowances granted to customers or wholesalers, or payments to government agencies (including[**]Medicare, Medicaid, government, commercial and similar types or rebates and chargebacks), whether in cash or trade; and

(d) Charges for bad debt, freight, shipping, packing and insurance and other transportation charges incurred in shipping a Royalty-Bearing Product to Third Parties; and

(e) Credits or allowances (actually paid or allowed) for wastage replacement, whether in cash or trade.

In the case of any sale of Royalty-Bearing Products for consideration other than cash, such as barter or countertrade, Net Sales shall be calculated on the fair market value of the consideration received. Any disposal of Royalty-Bearing Products for, or use of Royalty-Bearing Products in, clinical or pre-clinical trials or as free samples shall not give rise to any deemed sale under this Section 1.49.

Section 1.50 Non-Royalty-Bearing Product . “Non-Royalty-Bearing Product” shall mean any product containing [**] that is not a Royalty-Bearing Product.

Section 1.51 Omitted .

 

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Section 1.52 Party or Parties . “Party” shall mean Amgen or Infinity. “Parties” shall mean Amgen and Infinity.

Section 1.53 Patent Rights . “Patent Rights” shall mean all existing patents and patent applications and all patent applications hereafter filed and patents hereafter issued, including without limitation any continuations, continuations-in-part, divisions, provisionals or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplemental protection 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.

Section 1.54 Phase IIB Study . “Phase IIB Study” shall mean a well controlled dose ranging clinical study to evaluate the efficacy and safety of a candidate drug in the targeted patient population and to define the optimal dosing regimen.

Section 1.55 Phase III Study . “Phase III Study” shall mean a well controlled clinical study commenced after the completion of a Phase IIB Study to confirm with statistical significance the efficacy and safety of a candidate drug in targeted patient populations, performed to obtain Regulatory Approval of a product.

Section 1.56 Program Compound . “Program Compound” shall mean an [**] or [**].

Section 1.57 Regulatory Approval . “Regulatory Approval” shall mean any and all approvals (excluding any applicable governmental price and reimbursement approvals), licenses, registrations, or authorizations of any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity that are necessary and sufficient for the marketing and sale of a product in a country or group of countries.

Section 1.58 Regulatory Authority . “Regulatory Authority” shall mean the FDA in the United States and EMEA in the EU and the MHW in Japan.

Section 1.59 Omitted .

Section 1.60 Omitted .

Section 1.61 Omitted .

Section 1.62 Royalty-Bearing Product . “Royalty-Bearing Product” shall mean a pharmaceutical composition in finished product form comprising a [**], provided , that such [**] is (a) [**]or (b) [**] that was confirmed by [**] during the Combined Term.

Section 1.63 Omitted .

Section 1.64 Sublicensee(s) . “Sublicensee(s)” shall mean any and all Third Party(ies) to which Amgen grants any right to research, develop, make, use, sell, offer for sale or import Royalty-Bearing Products in accordance with Section 3.3 hereof. Solely for purposes of computation of royalties payable to Infinity under Section 4.5 of this Agreement, a Third Party(ies) who is granted only the right to sell a Royalty-Bearing Product (such as a wholesaler,

 

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distributor, contract sales force or other person providing products directly to patients in a home health care setting, as long as Amgen, its Affiliate or Sublicensee records the sales of such Royalty-Bearing Product upon transfer to such Third Party) or to use a Royalty-Bearing Product (such as a customer receiving an implied license as a consequence of purchase) shall not be considered a Sublicensee(s).

Section 1.65 Omitted .

Section 1.66 Synthetic Methodology and Pathways . “Synthetic Methodology and Pathways” shall mean, with respect to a Library Compound, the synthetic scheme that Infinity used to synthesize the Library Compound, which Infinity delivered to Amgen pursuant to the Prior Agreement.

Section 1.67 Target . “Target” shall mean a protein or polypeptide, which is involved in a biological process as well as [**].

Section 1.68 Territory . “Territory” shall mean all the countries of the world.

Section 1.69 Third Party . “Third Party” shall mean any person or entity other than a Party or any of its Affiliates.

Section 1.70 Additional Definitions . Each of the following definitions is set forth in the section of this Agreement indicated below:

 

 

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ARTICLE 2

USE OF LIBRARY COMPOUNDS

Section 2.1 DRUG DISCOVERY PROGRAMS .

2.1.1 Amgen shall use reasonable efforts consistent with standards in the pharmaceutical and biotechnology industries to maintain a reliable record relating to the existence of each Drug Discovery Program, including notations as to when particular [**] were designed, discovered or synthesized by Amgen in the course of a Drug Discovery Program. With respect to each [**], which Amgen determines to be a Hit during the Combined Term, Amgen shall analyze, unless it had previously done so, whether the [**] is derived is a Hit against the same Amgen Target. In the event that Infinity reasonably has reason to believe that any pharmaceutical compound sold or offered for sale by or on behalf of Amgen is [**], Infinity may request from time to time on a reasonable basis, and Amgen shall provide, (a) [**], and (b) [**]. In the event that the Parties dispute whether [**], either Party may seek the resolution of such dispute in accordance with Section 9.2.

2.1.2 Amgen shall notify Infinity of the existence of each Drug Discovery Program, by providing to Infinity (a) a coded identifier for the Library Compound(s) that achieved the status of Hit and (b) a coded identifier for the Amgen Target(s) against which such Library Compound(s) was confirmed to be a Hit.

2.1.3 Amgen shall be responsible for performing all biological assays it, in its sole discretion, deems appropriate in its Drug Discovery Program(s) (if any), and Infinity shall have no responsibility for performing any biological assays.

Section 2.2 DESTRUCTION OF UNUSED QUANTITIES OF LIBRARY COMPOUNDS .

(a) At the end of the Combined Term,

(i) Amgen shall destroy all unused quantities of Library Compounds except for unused quantities of Library Compounds confirmed by Amgen to be Hits during the Combined Term;

 

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(ii) Amgen shall use commercially reasonable efforts to destroy all Library Compound Information, including all smile string information, in its possession, except for (A) [**] archival copies of all written materials delivered to Amgen by Infinity (whether in electronic or hard-copy form) retained by Amgen for the purposes of managing Patent Prosecution and its non-use obligations (including avoiding claiming Library Compounds in patent applications to the extent required by Section 5.1.3(c)) under this Agreement and (B) Library Compound Information recorded in Amgen laboratory notebooks or other business records maintained in the ordinary course of Amgen’s business and (C) Library Compound Information relating to Library Compounds confirmed by Amgen as Hits during the Combined Term for uses licensed under Article 3 of this Agreement. Amgen shall use commercially reasonable efforts to terminate its use of all Library Compound Information in its possession (except to the extent permitted in clauses (A) and (C)). Amgen shall use commercially reasonable efforts to notify relevant employees and agents of its non-use obligations hereunder.

(b) At the end of the Exclusivity Option Term,

(i) Amgen shall destroy all unused quantities of Library Compounds confirmed by Amgen to be Hits during the Combined Term, except for unused quantities of (A) Exclusive Library Compounds and potential Back-Up Library Compounds related thereto, and (B) [**] that are the subject of a [**], provided that upon termination of such [**], Amgen shall destroy unused quantities of such Library Compounds; and

(ii) Amgen shall use commercially reasonable efforts to destroy all Library Compound Information, including all smile string information, in its possession relating to Library Compounds confirmed by Amgen as Hits during the Combined Term except for (A) [**] archival copies of all written materials delivered to Amgen by Infinity (whether in electronic or hard-copy form) retained by Amgen for the purposes of managing Patent Prosecution and its other non-use obligations (including avoiding claiming Library Compounds in patent applications to the extent required by Section 5.1.3(c)) under this Agreement and (B) Library Compound Information recorded in Amgen laboratory notebooks or other business records maintained in the ordinary course of Amgen’s business, and (C) Library Compound Information relating to Exclusive Library Compounds for uses licensed under Article 3 of this Agreement and potential Back-Up Library Compounds related thereto and (D) Library Compound Information relating to [**] for uses licensed under Article 3 of this Agreement, provided that upon termination of any such Drug Discovery Program (other than as a result of commercialization of a Royalty-Bearing Product relating thereto) Amgen shall use commercially reasonable efforts to destroy such Library Compound Information. Amgen shall use commercially reasonable efforts to terminate use of all Library Compound Information in its possession (except to the extent permitted in clauses (A), (C) and (D)). Amgen shall use commercially reasonable efforts to notify relevant employees and agents of its non-use obligations hereunder.

2.2.2 At all times during and after the end of the Combined Term, Amgen shall have the continuing right to retain and use all Exclusive Library Compound Information and Amgen Analog Information (to the extent permitted by the other provisions of this Agreement), provided that this provision is not intended to act as the grant of rights under any valid and enforceable Infinity Patent Rights.

 

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2.2.3 For so long as Amgen has physical access to Library Compounds, the identity of such compounds will be determined by the molecular formula and molecular structure described in the Library Compound Structure Information, provided that the structure of each Library Compound shall be deemed to be the structure identified to Amgen in the Library Compound Information provided by Infinity to Amgen under the Prior Agreement except to the extent that Amgen has actual knowledge that the compound(s) in a given well have a different structure and Amgen actually knows that structure. At the end of the period in which Amgen has physical access to Library Compounds, the Library Compound Information provided by Infinity to Amgen under the Prior Agreement will be deemed to be conclusive for purposes of determining the Parties’ rights and obligations under this Agreement; provided that , any more accurate structural information actually known by Amgen during the period in which Amgen has physical access to the Library Compounds will be used to identify such compounds at the end of such period.

2.2.4 The provisions of Exhibit A shall apply with respect to the Synthetic Methodology and Pathways information and the Library Compound Structure Information.

ARTICLE 3

LICENSES

Section 3.1 INFINITY GRANTS .

3.1.1 License With Respect to Library Compounds . Infinity hereby grants to Amgen a worldwide, non-exclusive license, under Infinity Intellectual Property, to use Library Compounds and Library Compound Information for research purposes in the discovery of Hits to Amgen Targets, performing Hit-to-Lead Chemistry Programs and Lead Optimization Programs and in the Development of Royalty-Bearing Products that contain Library Compounds (which license shall include the right to use Synthetic Methodology and Pathways solely to synthesize Library Compounds which have been identified as Hits (and Library Compounds structurally related thereto), and [**] that derive from such Library Compounds, for the purpose of performing Drug Discovery Programs). With respect to any Library Compound confirmed by Amgen as a Hit during the Combined Term, the license set forth in this Section 3.1.1 shall survive until the permanent cessation by Amgen of all research and Development activities with respect to the relevant Library Compound or Program Compound that commenced with confirmation of such Library Compound as a Hit and thereupon expire. With respect to any Exclusive Library Compound, the license set forth in this Section 3.1.1 shall immediately and automatically become exclusive (even with respect to Infinity, but subject to any non-exclusive research licenses that had been granted by Infinity to Third Parties with respect to the relevant Library Compound prior to such Library Compound becoming an Exclusive Library Compound) upon Amgen’s payment of the Library Compound Exclusivity Fee pursuant to Section 3.6.1 of this Agreement and such license shall survive in perpetuity (subject to any terms and conditions of this Agreement expressly providing for the termination of such license). Subject to Section 3.3, the licenses set forth in this Section 3.1.1 shall further include the right to grant sublicenses to Affiliates of Amgen and to Third Party collaborators (provided such collaborators are under an obligation to not determine the structure of any Library Compound) and Third Party contractors engaged solely on a fee-for-service basis.

 

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3.1.2 Licenses With Respect to Analogs. Infinity hereby grants to Amgen a worldwide, perpetual (subject to any terms and conditions of this Agreement expressly providing for the termination of such licenses), non-exclusive license, under Infinity Intellectual Property, to use Analogs and [**] Information in the discovery of Hits to Amgen Targets, performing Hit-to-Lead Chemistry Programs and Lead Optimization Programs and in the Development of Royalty-Bearing Products [**]. Subject to Section 3.3, the licenses set forth in this Section 3.1.2 shall further include the unrestricted right to grant sublicenses.

3.1.3 License Limitation and Clarification.

(a) For the avoidance of doubt, the purpose of the licenses granted in Sections 3.1.1 and 3.1.2 with respect to Synthetic Methodology and Pathways is to perform Hit-to-Lead Chemistry Programs and Lead Optimization Programs and in the Development of Royalty-Bearing Products that contain Program Compounds [**], and not to enable Amgen to use Synthetic Methodology and Pathways broadly to duplicate all or substantially all of Infinity’s libraries of Library Compounds delivered to Amgen for purpose of conducting primary screening.

(b) The Parties understand, agree and hereby acknowledge that, to the extent permitted by the other provisions of this Agreement, Amgen will and shall have [**] to include all [**] and [**] and [**] and [**], including, without limitation, [**] and [**] ( provided , however , that for the avoidance of doubt, [**].

3.1.4 Exclusive Commercialization License With Respect to Exclusive Library Compounds. Infinity hereby grants to Amgen a worldwide, exclusive license, under Infinity Intellectual Property, to make, use, sell, offer to sell, have sold, import and otherwise exploit, transfer physical possession of and transfer title or interest in Exclusive Library Compounds for any purposes. Any sales of products containing Exclusive Library Compounds shall be treated as [**] under this Agreement. Such license shall survive in perpetuity subject to any terms and conditions of this Agreement expressly providing [**] of such license. Subject to Section 3.3, the licenses set forth in this Section 3.1.4 shall further include the [**].

3.1.5 Commercialization Licenses With Respect to Analogs. Infinity hereby grants to Amgen a worldwide, perpetual (subject to any terms and conditions of this Agreement expressly providing [**] of such license), non-exclusive license, under Infinity Intellectual Property that [**] and [**] to [**] as [**] and as [**], as the case may be. Subject to Section 3.3, the licenses set forth in this Section 3.1.5 shall further include the [**].

Section 3.2 LIMITED AMGEN GRANT. If in the course of using Library Compounds, Analogs or Know-How related thereto Amgen makes an invention which results in the filing of Patent Rights, Amgen hereby grants to Infinity a worldwide, royalty-free, non-exclusive license [**]. Such Amgen license is [**] including, without limitation, [**]. Such license shall survive in perpetuity subject to any terms and conditions of this Agreement expressly providing [**] of such license, including without limitation the provisions of Section 3.6.4. Subject to [**], such license shall further include the [**].

Section 3.3 SUBLICENSE RIGHTS . Wherever in this Agreement either Party is granted the right to grant sublicenses (including granting to sublicensees the right to grant further

 

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sublicenses for the purposes of having Library Compounds and Analogs made) subject to this Section 3.3, such Party may exercise such right without obtaining the prior approval of the other Party, provided that such sublicense occurs pursuant to a written agreement that subjects such sublicensee to all relevant restrictions and limitations in this Agreement; and provided , further , that, except with respect to sublicenses granted with respect to [**], Amgen shall promptly notify Infinity of the identity of any Third Party sublicensee. Except as otherwise agreed to by the Parties in writing, each Party shall be jointly and severally responsible with its sublicensees to the other Party for failure by its sublicensees to comply with, and each Party guarantees the compliance by each of its sublicensees with, all such applicable restrictions and limitations in accordance with the terms and conditions of this Agreement.

Section 3.4 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 Title 11 of the United States Code, as amended (such Title 11, 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 the Bankruptcy Code.

Section 3.5 NO IMPLIED LICENSES OR RIGHTS. Except as expressly provided in this Agreement, neither Party shall have any license or other interest in any intellectual property rights Controlled by the other Party.

Section 3.6 LIBRARY COMPOUND EXCLUSIVITY OPTION.

3.6.1 Option.

(a) During the Exclusivity Option Term, Amgen shall have the right to exercise the Library Compound Exclusivity Option in accordance with this Section 3.6.1 with respect to each Library Compound that has been identified as a Hit (or is structurally related to a Hit) which Amgen selects to move forward in a Drug Discovery Program. In the event that Amgen desires to exercise the Library Compound Exclusivity Option with respect to a Library Compound, Amgen shall give Infinity written notice of such desire prior to the end of the Exclusivity Option Term, which notice shall specify the Library Compound with respect to which Amgen desires to exercise the Library Compound Exclusivity Option.

(b) Within [**] Business Days after receiving Amgen’s notice, Infinity shall notify Amgen of whether, prior to the date of receipt of Amgen’s notice, (i) [**] and [**], (ii) Infinity [**] directed to the same [**] requested by Amgen and Infinity is [**] either [**] or [**] or (iii) Infinity has [**] that specifically claims the [**] requested by Amgen and has [**] therefor. If any of the conditions described in clauses (i), (ii) or (iii) of the immediately preceding sentence exist, then Amgen shall not be permitted to exercise the Library Compound Exclusivity Option with respect to such Library Compound; provided that if the condition(s) that make such Library Compound unavailable later cease to exist at any time within five (5) years after the end of the Exclusivity Option Term, Infinity shall promptly notify Amgen in writing of such cessation and Amgen shall thereupon have the right to exercise the Library Compound Exclusivity Option with respect to such Library Compound in accordance with this Section 3.6.1. In the event that none of the conditions described in clauses (i), (ii) or (iii) of this Section

 

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