COLLABORATION AGREEMENT

 

COLLABORATION AGREEMENT

THIS COLLABORATION AGREEMENT dated as of the 25th day of August, 2006 (the “ Agreement ”) is made between MedImmune, Inc., a Delaware corporation having its principal place of business at One MedImmune Way, Gaithersburg, Maryland 20878 (“ MedImmune ”) and Infinity Pharmaceuticals, Inc., a Delaware corporation having its principal office at 780 Memorial Drive, Cambridge, Massachusetts 02139 (“ Infinity ”).

R E C I T A L S

WHEREAS, the Parties wish to collaborate on the development and commercialization of the Products (as defined herein);

NOW THEREFORE, in consideration of the premises and of the covenants herein contained, the Parties hereto mutually agree as follows:

ARTICLE 1

DEFINITIONS

For purposes of this Agreement, the terms defined in this Article shall have the meanings specified below, whether used in their singular or plural form:

1.1.        “ Active Pharmaceutical Ingredient ” or “ API ” means the active ingredient in a drug responsible for its therapeutic effect including isomer, ester, salt, hydrate, solvate, analog (i.e., one or a limited number of individual atoms or functional groups have been added, deleted or replaced, either with a different atom or with a different functional group, or any one of a series of organic compounds with a similar general formula, possessing similar chemical properties), conjugate, polymorph, prodrug, metabolic precursor or metabolite of such active ingredient.

1.2.        “ Affiliate ” with respect to either Party, means any corporation or other entity which controls, is controlled by, or is under common control with that Party.  A corporation or other

 

entity shall be regarded as in control of another corporation or entity if it directly or indirectly owns or controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the corporation or other entity.

1.3.          “ Applicable Percentage ” means fifty percent (50%).

1.4.          “ Business Day ” shall mean each day of the week excluding Saturday, Sunday and U.S. Federal holidays.

1.5.          “ Claims ” means all charges, complaints, actions, suits, proceedings, hearings, investigations, claims, demands, judgments, orders, decrees, stipulations and injunctions.  For the avoidance of doubt, Claims shall include Infringement Claims and Product Liability Claims.

1.6.          “ Collaboration Inventions ” means:

(a)           Inventions conceived and/or reduced to practice during the Term by an employee of a Party or any of its Affiliates and/or by a person or entity obligated to assign such an Invention to a Party or any of its Affiliates which Invention is directed to the development, manufacture, use or sale of an Active Pharmaceutical Ingredient of a Product; provided , however , with respect to Products of a Project as to which a Party is an Opt-Out Party, such Inventions are limited to those conceived and/or reduced to practice during the Term and prior to one year after the Opt-Out Date for such Project.  For the avoidance of doubt, for purposes of the foregoing, Inventions that are “directed to” an API shall not include general formulations and general manufacturing methodologies that are conceived and reduced to practice outside of the course of performing activities pursuant to a Research and Development Plan; and

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(b)           Inventions conceived and/or reduced to practice during the Term by an employee of a Party or any of its Affiliates and/or by a person obligated to assign such an Invention to a Party or any of its Affiliates that is conceived and/or reduced to practice in the course of performing activities pursuant to work conducted under a Research and Development Plan.

1.7.          “ Collaboration Know-How ” means:

(a)           Know-How conceived and/or reduced to practice and/or developed during the Term by an employee of a Party or any of its Affiliates and/or by a person or entity obligated to assign Know-How to a Party or any of its Affiliates which Know-How is directed to the development, manufacture, use or sale of an Active Pharmaceutical Ingredient of a Product; provided , however , with respect to Products of a Project as to which a Party is an Opt-Out Party, such Know-How is limited to that conceived and/or reduced to practice and/or developed during the Term and prior to one year after the Opt-Out Date for such Project.  For the avoidance of doubt, for purposes of the foregoing, Know-How that is “directed to” an API shall not include general formulations and general manufacturing methodologies that are conceived and reduced to practice outside of the course of performing activities pursuant to a Research and Development Plan; and

(b)           Know-How conceived and/or reduced to practice during the Term by an employee of a Party or any of its Affiliates and/or by a person obligated to assign such Know-How to a Party or any of its Affiliates that is conceived and/or reduced to practice in the course of performing activities pursuant to work conducted under a Research and Development Plan.

1.8.          “ Collaboration Patent Rights ” means any Patent Rights that claim a Collaboration Invention.

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1.9.          “ Collaboration Rights ” means individually and collectively Collaboration Patent Rights, Collaboration Know-How and Collaboration Inventions.

1.10.        “ Combination Product ” means a product that contains one or more active components that are not Products in addition to Product.

1.11.        “ Development Costs ” with respect to Product, on a Product-by-Product basis, means the reasonable costs incurred or accrued by a Party with respect to work performed by a Party or its Affiliates or a Third Party in accordance with a Research and Development Plan in connection with research and development of Product, including [***] for the purpose of submission of applications to obtain Regulatory Approvals for Product which costs are limited to [***].  All cost determinations made hereunder shall be made in accordance with GAAP.  As part of creating the initial Research and Development Plans, the JDT will agree on consistent policies governing direct and non-direct costs, including allocation principles.

1.12.        “ Diligent Effort ” means the carrying out of obligations specified in this Agreement in a diligent, expeditious and sustained manner, consistent with the combined interests of the Parties including the allocation of commercially reasonable personnel and financial resources, but in no event less than that level of resources that pharmaceutical and major biotechnology companies typically devote to their own internally discovered products of similar market potential at a similar stage in its development or product life, taking into account the following factors to the extent reasonable and relevant: issues of safety and efficacy, product profile, difficulty in developing or manufacturing the Product, competitiveness of alternative Third Party products in the marketplace, the patent or other proprietary position of the Product, the regulatory requirements involved and the potential profitability of the Products marketed or to be marketed.

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1.13.        “ Disclosure Schedule ” means the disclosure schedule delivered by Infinity to MedImmune dated as of the Effective Date.

1.14.        “ Earnings ” means the positive or negative amount that is calculated on a Product-by-Product basis by deducting Product Costs from Revenue.

1.15.        “ Effective Date ” means the date first set forth above.

1.16.        “ FDA ” means the United States Food and Drug Administration or any successor agency with responsibilities comparable to those of the United States Food and Drug Administration.

1.17.        “ Field ” means all fields of use.

1.18.        “ First Commercial Sale ” means the first sale of a Product for consumption by the general public in a country.

1.19.        “ Fully Absorbed Cost of Goods ” with respect to Product, on a Product-by-Product basis, means:

(a)           To the extent that manufacturing of Product or any component thereof is performed by the Selling Party itself, the consolidated fully burdened cost incurred by the Selling Party in the manufacture of Product, which costs are limited to: [***] as determined in accordance with GAAP; and

(b)           To the extent that manufacturing of Product or any component thereof is performed for the Selling Party by a Third Party or by the other Party, amounts paid by the Selling Party to such Third Party or to the other Party in connection with the manufacturing of Product or any component thereof.

1.20.        “ GAAP ” means the then current United States generally accepted accounting principles, consistently applied.

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1.21.        “ Hsp90 Diagnostic ” means a product or service for determining a person that is susceptible to treatment with a Hsp90 Therapeutic and/or monitoring such treatment and/or providing a prognosis of such treatment, in each case such treatment being for the purpose of treating and/or preventing a disease, disorder or condition.

1.22.        “ Hsp90 Product ” means an Hsp90 Diagnostic or an Hsp90 Therapeutic.

1.23.        “ Hsp90 Therapeutic ” means one or more molecules that primarily (i.e. the most potent activity) target and modulate one or more of Heat Shock Protein 90 (Hsp90) [***] and compositions that contain such a molecule(s).  For the avoidance of doubt, the chemical entities disclosed and/or claimed in the Patent Rights indicated in Exhibit Y and IPI 504 (structure in Exhibit Z-1) are included as Hsp90 Therapeutics.

1.24.        “ Hsp90 Project ” means the research, development and commercialization of one or more Hsp90 Products.

1.25.        “ Hedgehog Diagnostic ” means a product or service for determining a person that is susceptible to treatment with a Hedgehog Therapeutic and/or monitoring such treatment and/or providing a prognosis of such treatment, in each case such treatment being for the purpose of treating and/or preventing a disease, disorder or condition.

1.26.        “ Hedgehog Product ” means a Hedgehog Diagnostic or a Hedgehog Therapeutic.

1.27.        “ Hedgehog Therapeutic ” means one or more molecules that primarily target (i.e. the most potent activity) and modulate one or more member(s) of the Hedgehog pathway and compositions that contain such a molecule(s).  For the avoidance of doubt, the chemical entities disclosed and/or claimed in the Patent Rights indicated in Exhibit Y [***] (structures in Exhibit Z-2)  are included as Hedgehog Therapeutics.

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1.28.        “ Hedgehog Project ” means the research, development and commercialization of one or more Hedgehog Products.

1.29.        “ IND ” means an Investigational New Drug application filed with a Regulatory Authority to obtain approval to conduct human clinical trials of a Product for an Indication.

1.30.        “ Indication ” means a type of cancer (tumor type) or a disease, disorder or a condition other than a type of cancer.

1.31.        “ Infinity Existing Know-How ” means any Know-How owned by or licensed to Infinity as of the Effective Date which is directed to the development, manufacture, use or sale of an Active Pharmaceutical Ingredient of a Product.  For the avoidance of doubt, for purposes of the foregoing, Know-How that is “directed to” an API shall not include general formulations and general manufacturing methodologies that are conceived and reduced to practice outside of the course of performing activities pursuant to a Research and Development Plan.

1.32.        “ Infinity Existing Patent Rights ” means (i) any Patent Rights set forth on Exhibit Y, (ii) any Patent Rights that may arise from the Inventions set forth in Exhibit Y, and (iii) any Patent Rights owned by or licensed to Infinity as of the Effective Date that claim an Active Pharmaceutical Ingredient of a Product or the manufacture or use thereof.

1.33.        “ Infinity Existing Rights ” means individually and collectively Infinity Existing Patent Rights and Infinity Existing Know-How.

1.34.        “ Infinity General Invention ” means any Invention, other than a Collaboration Invention or MedImmune General Invention (i) owned by Infinity or any of its Affiliates before or during the Term and/or (ii) licensed to Infinity or any of its Affiliates before or during the Term, with the right in each case to grant a sublicense hereunder in each case, which Invention is useful or necessary with respect to the development, manufacture, use or sale of a Product;

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provided, however , with respect to Products of a Project as to which Infinity is an Opt-Out Party, such Inventions that become owned or licensed with respect to such Products during the Term are limited to those that become owned or licensed during the Term and prior to one year after the Opt-Out Date for such Project.

1.35.        “ Infinity General Patent Rights ” means any Patent Rights, other than Collaboration Patent Rights, Infinity Existing Patent Rights or MedImmune General Patent Rights, that claim an Infinity General Invention.

1.36.        “ Infinity General Know-How ” means any Know-How, other than Collaboration Know-How, Infinity Existing Know-How or MedImmune General Know-How, (i) owned by Infinity or its Affiliates before or during the Term or (ii) licensed to Infinity or any of its Affiliates before or during the Term, with the right in each case to grant a sublicense hereunder, in each case which Know-How is useful or necessary with respect to the development, manufacture, use or sale of a Product; provided, however , with respect to Products of a Project as to which Infinity is an Opt-Out Party, such Know-How that becomes owned or licensed with respect to such Products during the Term is limited to Know-How that becomes owned or licensed during the Term and prior to one year after the Opt-Out Date for such Project.

1.37.        “ Infinity General Rights ” means individually and collectively Infinity General Patent Rights, Infinity General Know-How and Infinity General Inventions.

1.38.        “ Infringement Claim ” means a Claim by a Third Party that the making, using, offering for sale, sale or importation of a Product infringes any Third Party intellectual property right.

1.39.        “ Invention ” means all ideas, data, writings, inventions, discoveries, improvements and other technology, whether or not patentable or copyrightable.

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1.40.        “ JCT ” means the Joint Commercialization Team of Section 6.2.

1.41.        “ JDT ” means the Joint Development Team(s) of Article 3.

1.42.        “ Know-How ” means data, information, know-how, compounds and reagents and the rights thereto other than Patent Rights.

1.42A      “ Litigation Expenses ” means court costs, reasonable fees of attorneys, accountants and other experts or other expenses of litigation or other proceedings or of any claim, default or assessment.

1.42B      “ Loss(es) ” means all damages (including all incidental and consequential damages claimed by Third Parties), deficiencies, defaults, assessments, dues, penalties, fines, costs, amounts paid in settlement, liabilities, obligations, taxes, liens, losses, lost profits claimed by Third Parties, expenses, costs and fees (including without limitation interest, but excluding Litigation Expenses) and includes all damages awardable pursuant to statute and treble damages.

1.43.        “ Marketing Expenses ” means w ith respect to a Product, on a Product-by-Product basis, the reasonable costs incurred or accrued pursuant to a Marketing Plan by the Selling Party or reimbursed to the Non-Selling Party pursuant to co-promotion under this Agreement, with respect to pre-launch, launch, and post-launch advertising and other marketing activities including, without limitation, expenses of patient programs such as those involving compassionate use, indigents, uninsured and underinsured, training, disease information and management, and compliance; expenses related to Promotional Materials, space or time in various media, direct mail campaigns, samples, advertising agency fees and other promotion activities; and phase IV studies (whether or not required by a Regulatory Authority) which costs are limited to: [***].  All cost determinations made hereunder shall be made in accordance with GAAP.  Marketing Expenses do not include Selling Expenses.  Marketing Expenses incurred by

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a Selling Party with respect to a Product shall not materially exceed the aggregate expenses associated with the marketing (defined in the same way as Marketing Expenses) of similar products by Third Parties that are pharmaceutical or major biotechnology companies.

1.44.        “ Marketing Plan ” means the Marketing Plan of Section 6.2.

1.45.        “ MedImmune General Invention ” means any Invention, other than a Collaboration Invention or Infinity General Invention (i) owned by MedImmune or any of its Affiliates before or during the Term and/or (ii) licensed to MedImmune or any of its Affiliates before or during the Term, with the right in each case to grant a sublicense hereunder, in each case, which Invention is useful or necessary with respect to the development, manufacture, use or sale of a Product; provided, however , with respect to Products of a Project as to which MedImmune is an Opt-Out Party, such Inventions that become owned or licensed with respect to such Products during the Term are limited to those that become owned or licensed during the Term and prior to one year after the Opt-Out Date for such Project.

1.46.        “ MedImmune General Patent Rights ” means any Patent Rights, other than Collaboration Patent Rights and Infinity General Patent Rights, that claim a MedImmune General Invention.

1.47.        “ MedImmune General Know-How ” means any Know-How, other than Collaboration Know-How, Infinity Existing Know-How and Infinity General Know-How, (i) owned by MedImmune or its Affiliates before or during the Term or (ii) licensed to MedImmune or any of its Affiliates before or during the Term, with the right in each case to grant a sublicense hereunder, in each case which Know-How is useful or necessary with respect to the development, manufacture, use or sale of a Product; provided, however , with respect to Products of a Project as to which MedImmune is an Opt-Out Party, such Know-How that becomes owned

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 or licensed with respect to such Products during the Term is limited to Know-How that becomes owned or licensed during the Term and prior to one year after the Opt-Out Date for such Project.

1.48.        “ MedImmune General Rights ” means individually and collectively MedImmune General Patent Rights, MedImmune General Know-How and MedImmune General Inventions.

1.49.        “ Net Sales ” means with respect to Product and Royalty Bearing Product on a Product-by-Product and Royalty Bearing Product by Royalty Bearing Product basis, the gross sales accrued in a particular period for financial reporting purposes of any and all Products and Royalty Bearing Product sold by a Selling Party or its Affiliates to a Third Party and included in reported net sales under GAAP after deducting for the following sales allowances and expenses directly related to gross sales of the applicable Product or Royalty Bearing Product, as determined by such Party under GAAP, if not previously deducted, from the gross sales amount invoiced:

(a)           trade, quantity and/or cash discounts, allowances or rebates, including promotional, service or similar discounts or rebates and discounts or rebates to governmental or managed care organizations, to the extent actually given or allowed;

(b)           credits or allowances with respect to Products or Royalty Bearing Products by reason of rejection, defects, recalls or returns, or chargebacks;

(c)           any tax, tariff, duty or government charge (including any sales, value added, excise or similar tax or government charge, but excluding any income tax) levied on the sale, transportation or delivery of any Product or Royalty Bearing Product;

(d)           a reasonable allowance for bad debt;

(e)           any charges for freight, postage, shipping or transportation, or for insurance (if and to the extent included in the amount invoiced to the Third Party); and

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(f)            any administrative fees owed to group purchasing organizations or managed care entities for sale of such Products or Royalty Bearing Products.

The Selling Party shall make periodic adjustments of the amounts described in (a) through (f) to its initial accruals of such amounts applied in a prior calendar quarter to reflect amounts actually incurred or taken by such Party; provided, however, that it shall use the same accrual that it uses for its own financial accounting purposes, and that it shall account for reserves and allowances for such Products or Royalty Bearing Products in a manner consistent with its methods for establishing reserves and allowances for other similar products.

(A)          In the event a Product or Royalty Bearing Product is sold as part of a Combination Product and the Product or Royalty Bearing Product, as well as each of the other clinically active components included in the Combination Product (the “Other Products”), are sold separately in the relevant country, the Net Sales from such Combination Product, shall be the amount determined by multiplying the Net Sales of the Combination Product, during the applicable reporting period, by the fraction, A/A+B, where A is the average gross sales price of the Product or Royalty Bearing Product when sold separately in finished form and B is the average gross sales price of the Other Products when such Other Products are sold separately in finished form, in each case during the applicable reporting period or, if sales of both the Product or Royalty Bearing Product, and the Other Products did not occur in such period, then in the most recent reporting period in which sales of both occurred.

(B)           In the event a Product or Royalty Bearing Product is sold as part of a Combination Product and average gross sales price cannot be determined for such Product or Royalty Bearing Product and all Other Product(s) included in the Combination Product, Net Sales, shall be calculated by multiplying the Net Sales of the Combination Product by the

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fraction C/(C+D) where C is the standard Fully-Absorbed Cost of Goods of the Product or Royalty Bearing Product and D is the standard fully-absorbed cost of the Other Products, calculated in the same manner as Fully Absorbed Cost of Goods, in each case during the applicable reporting period.

1.50.        “ Opt-Out-Date ” has the meaning of Section 12.1.

1.51.        “ Opt-Out-Party ” has the meaning set forth in Section 12.1.

1.52.        “ Non-Selling Party ” means, on a Product-by-Product basis, on a country-by-country basis, any Party who is not a Selling Party, provided that such Party is not an Opt-Out Party with respect to the Project of which the Product is a member.

1.53.        “ Patent Rights ” means United States and foreign patents, patent applications, provisional patent applications, certificates of invention, applications for certificates of invention, divisions, continuations, continuations-in-part, non-provisional patent applications claiming priority benefit of a provisional application, continued prosecution applications, national and regional stage counterparts, together with any extensions, registrations, confirmations, reissues, re-examinations or renewals of the above as well as supplementary protection certificates therefore, and any other form of government-issued patent protection directed to the inventions claimed in the foregoing.

1.54.        “ Party ” means Infinity or MedImmune and collectively the “Parties”.

1.55.        “ Phase I Clinical Trial ” means, as to a Product, the first controlled and lawful study in humans of the safety of such Product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase II Clinical Trial of such Product, as further exemplified in Federal Regulation 21 C.F.R. 312.21(a), or corresponding non-US applicable laws.

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1.56.        “ Phase II Clinical Trial ” means, as to a Product, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Product, which is prospectively designed to generate sufficient data (if successful) to commence a Pivotal Trial of such Product, as further exemplified in Federal Regulation 21 C.F.R. 312.21(b), or corresponding non-US applicable laws.

1.57.        “ Pivotal Trial ” means, as to a Product, a controlled and lawful study in humans of the clinical benefit of such Product, which is prospectively designed to generate sufficient data (if successful) to support Regulatory Approval (including Subpart H) of such pharmaceutical product or label expansion of such pharmaceutical product, as further exemplified in Federal Regulation 21 C.F.R. 312.21(c).

1.58.        “ Primary Contact Person ” has the meaning set forth in Section 2.7 hereof.

1.59.        “ Product ” means an Hsp90 Product and/or Hedgehog Product.

1.60.        “ Product Costs ” means on a Product-by-Product basis the aggregate of all expenses of either Party (including accruals legitimately chargeable against profits) in connection with the commercialization, manufacture and distribution of Product, consisting of only the following:

[***].

1.60B      “ Product Liability Claim ” means (i) a Claim by a Third Party that a Product has resulted in personal injury or death or (ii) a medical monitoring Claim by a Third Party (e.g., a Claim in anticipation of or intended to prevent or forestall personal injury or death as the result of a Product).

1.61.        “ Product Revenues ” means on a Product-by-Product basis any and all revenue received by the Selling Party for Product (other than Net Sales ) and/or rights to Product and/or under an agreement with respect to Product (other than Net Sales), including, but not limited to,

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(a) monies received pursuant to a license(s) such as upfront fees, milestones, royalties, monies received for marketing rights and/or distribution rights and (b) and monies received as damages and/or in settlement of a legal action(s) with respect to Product.

1.62.        “ Project ” means Hedgehog Project and/or Hsp90 Project.

1.63.        “ Promotional Materials ” means advertising, promotional, educational and communication materials, in whatever form or medium, for marketing, advertising and promotion of a Product for distribution to a Third Party (including without limitation medical professionals) and to a Party’s sales force in accordance with the terms of the Marketing Plan.

1.64.        “ Recall Expense ” means the cost and expense calculated in accordance with GAAP for recall or market withdrawal of Product required or requested by a governmental authority having jurisdiction thereover or as a result of a decision of the Selling Party, including, but not limited to, expenses incurred for replacement of Product.

1.65.        “ Regulatory Approval(s) ” means any and all approvals from regulatory authorities in any country or region required lawfully to manufacture and market Product in any such country or region, including without limitation any Product pricing and reimbursement approvals where applicable.

1.66.        “ Regulatory Authority ” means any national (e.g., the FDA), supra-national (e.g., the EMEA) or other regulatory agency or governmental entity involved in the granting of Regulatory Approval for, or in the regulation of human clinical studies of, Product.

1.67.        “ Research and Development Plan ” means for each Project each research and development plan and amendments thereto that is approved by the JDT.

1.68.        “ Revenue ” means on a Product-by-Product basis the aggregate of Net Sales and Product Revenues.

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1.69.        “ Royalty Percentage ” means on a Product-by-Product basis the following percentage depending on the stage of development of each Product in the Project as of the Opt-Out Date for the Project:

Opt-Out Date		Percentage
i. Up to dosing of a patient in a Phase I Clinical Trial		[***] Percent ([***]%)
ii. After dosing of a patient in a Phase I Clinical Trial and up to dosing of a patient in a Phase II Clinical Trial		[***] Percent ([***]%)
iii. After dosing of a patient in a Phase II Clinical Trial up to dosing of a patient in a Pivotal Trial		[***] Percent ([***]%)
iv. After dosing of a patient in a Pivotal Trial up to filing for Regulatory Approval in the United States.		[***] Percent ([***]%)
v. After filing for Regulatory Approval in the United States and thereafter.		[***] Percent ([***]%)

 

1.70.        “ Royalty Bearing Product ” means a Product of a Project as to which Project a Party has exercised Opt-Out rights under Article 12.

1.71.        “ Selling Expenses ” means with respect to a Product, on a Product-by-Product basis, the reasonable costs incurred or accrued by the Selling Party with respect to the selling of the Product in the Territory which costs are limited to: [***].  All cost determinations made hereunder shall be made in accordance with GAAP.  Selling Expenses incurred by a Selling Party with respect to a Product shall not materially exceed the aggregate expenses associated with the selling (defined in the same way as Selling Expenses) of similar products by Third Parties that are pharmaceutical or major biotechnology companies.

1.72.        “ Selling Party ” means, with respect to a given Product in a country, (i) MedImmune and its Affiliates unless MedImmune becomes an Opt-Out-Party, in which case, if Infinity at such time is a Non-Selling Party, Infinity may become the Selling Party or (ii) Infinity and its

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Affiliates, if Infinity becomes the Selling Party for such Product in such country under Section 5.4.

1.73.        “ Sublicensee ” means any person or entity (other than a contract distributor having no right to promote, market or sell the Product) that receives from a Selling Party a permitted sublicense to promote, market, or sell the Product.

1.74.        “ Term ” has the meaning set forth in Section 14.1.

1.75.        “ Territory ” means the world.

1.76.        “ Third Party ” means any entity other than Infinity or MedImmune and their respective Affiliates.

1.77.        “ Valid Claim ” means an issued claim of an unexpired patent, included within Collaboration Patent Rights and/or Infinity Existing Patent Rights and/or patents licensed to a Selling Party under this Agreement which has not been abandoned with no rights remaining, disclaimed, held permanently revoked, or held invalid or unenforceable by a court of competent jurisdiction or administrative agency in an unappealed or unappealable decision, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

1.78.        “ Worldwide Net Sales ” means (i) aggregate Net Sales by the Selling Party and its Affiliates and (ii) aggregate net sales (calculated in the same manner as Net Sales) by Sublicensees of the Selling Party and its Affiliates and any further sublicensees.

ARTICLE 2

RESEARCH AND DEVELOPMENT COSTS

2.1           For each Project, MedImmune and Infinity, shall prepare a rolling research and development plan for the earlier of a three-year period or through projected Product approval which shall describe the research and development activities for the applicable Project, including

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without limitation research, pre-clinical studies, toxicology, formulation activities, manufacturing development, scale up of production process, and clinical trials as appropriate for the stage of research and development which shall be updated annually.  The research and development plan shall also include a summary of the estimated costs expected to be incurred under the research and development plan during the covered period and a description of, and budget for, all activities proposed for such period under the research and development plan.  In addition, the research and development plan shall specify the responsibilities and work to be performed by each Party, identify the number of personnel to be used by each Party in performing activities in connection with the research and development plan, as well as activities to be performed by Third Parties.

2.2           For each Project, MedImmune and Infinity each agree that it shall cause the JDT to approve a Research and Development Plan for each calendar year that includes a level of efforts, resources and monies sufficient to research, develop and manufacture Product and to seek Regulatory Approval of Product in at least the United States, Europe and Japan.  The initial rolling three-year Research and Development Plan for each Project shall be prepared and approved within thirty (30) days of the Effective Date and shall be consistent with the plan separately provided by Infinity to MedImmune on August 22, 2006.

2.3           (a)           The research and development plan prepared by the Parties (except for the initial Research and Development Plan), shall be submitted to the JDT for approval by no later than June 30 of the calendar year preceding the three (3) calendar years covered therein.  The research and development plan approved by the JDT in amended or unamended form for a Project shall be the Research and Development Plan for the Project.  The Research and Development Plan shall always be a rolling three year plan and the Research and Development

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Plan shall be updated or amended at least annually by no later than August 1 st  of each year preceding the year for which the update is being made.

(b)           Notwithstanding Section 2.3(a), the Research and Development Plans approved by the JDT after the initial Research and Development Plan with respect to the periods covered by the initial Research and Development Plan shall be consistent with the initial Research and Development Plan unless a change is required thereto as a result of a clinical hold, unavailability of clinical supply of Product and/or material events affecting the initial Research and Development Plan, in which case the Research and Development Plan for such period and the corresponding expenditures by the Parties thereunder will be adjusted accordingly by agreement of the JDT.

2.4           In a calendar year, unless approved in writing by the Parties, neither Party shall incur or enter into contracts to incur Development Costs that exceed [***] percent ([***]%) of the amount of the budget allocated to such Party for such calendar year under a Research and Development Plan.

2.5           Each Party shall report to the other Party through the JDT, the Development Costs actually incurred by each Party in a calendar quarter within twenty (20) calendar days after the end of the applicable calendar quarter.  The JDT shall determine the aggregate Development Costs for the applicable calendar quarter and determine the amount of Development Costs that should have been allocated to MedImmune based on the Applicable Percentage, and the Development Costs that should have been allocated to Infinity based on the Applicable Percentage.  The JDT shall report such calculation to both Parties within ten (10) Business Days after receiving the reports thereby communicating its determination as to Development Costs owed.  To the extent that a Party has incurred Development Costs in excess of the Development

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Costs that should have been incurred by such Party based on the Applicable Percentage, within (30) days, the other Party shall pay to such Party such excess so that each Party bears the Applicable Percentage of such aggregate Development Costs for such calendar quarter.

2.6           Each Party shall keep and shall cause each of its Affiliates and their contractors to keep full and accurate records and books of account containing all particulars that may be necessary for the purpose of calculating Development Costs to be charged to the other Party pursuant to this Agreement.  Such books of account shall be kept by a Party at its places of business and, with all necessary supporting data shall, for the three (3) years next following the end of the calendar year to which each shall pertain be open for inspection by auditors, which may be the other Party’s internal audit team or an independent certified accounting firm selected by the other Party and reasonably acceptable to the Party whose books are being inspected upon reasonable notice during normal business hours at the other Party’s expense for the sole purpose of verifying Development Costs in compliance with this Agreement, but in no event more than once each calendar year.  All information and data offered shall be used only for the purpose of verifying Development Costs.  In the event that such inspection shall indicate that in any calendar year the charges for Development Costs were overstated by at least five percent (5%), then the Party whose books are being inspected shall pay the cost of the inspection.  All underpayments and overpayments revealed by such audit are immediately due and payable.  Upon the expiration of three (3) years after a calendar year, the Development Costs reported by a Party for such period shall be binding on both Parties, except to the extent that inspection during such period indicated an overpayment or underpayment.

2.7           MedImmune and Infinity shall each designate an initial primary contact person (“ Primary Contact Person ”) who shall be responsible for the interactions between the Parties

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related to this Agreement.  The Primary Contact Persons shall attempt to promptly resolve any disputes that arise under a Project and, if they are unable to do so, such dispute shall be referred to the JDT.  Each Party may change its Primary Contact Person upon written notice to the other Party.  Each Party’s Primary Contact Person may also serve as one of its representatives on the JDT.  The Primary Contact Person for each Party shall designate for each Project one or more employees of such Party as members of a project team(s), who shall meet as often as needed to coordinate the work of the Parties under the applicable Research and Development Plan.

2.8           Know-How Transfers .

(a)           Infinity shall transfer to MedImmune Infinity Existing Know-How, Collaboration Know-How and Infinity General Know-How, as applicable, as requested by MedImmune to the extent the same is necessary or useful to enable MedImmune to perform its obligations and exercise its rights under this Agreement.

(b)           MedImmune shall transfer to Infinity MedImmune General Know-How and Collaboration Know-How, as applicable, as requested by Infinity to the extent the same is necessary or useful to enable Infinity to perform its obligations and exercise its rights under this Agreement.

ARTICLE 3

JOINT DEVELOPMENT TEAM

3.1           (a)           Until the Opt-Out-Date for a Project, each Project shall be managed and directed by a committee initially composed of six (6) members (which may be adjusted by the JDT, as long as there is an even number of members), with MedImmune appointing one-half of the members and Infinity one-half of the members (the “ JDT ”).  MedImmune and Infinity may

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also appoint such non-voting ex-officio members of the JDT as each Party may deem appropriate, provided that any such ex-officio member that is not an employee signs an appropriate confidentiality agreement.

(b)           The JDT shall meet at least once each calendar quarter in person or by telephone or by video conference.  A quorum for the conduct of business at any meeting of the JDT shall consist of at least one representative of MedImmune and at least one Infinity representative.  Each of Infinity and MedImmune, shall have one vote, and subject to Section 3.1(d) all decisions shall be reached by a unanimous vote.  The Parties shall cause the JDT to review and vote on each submitted research and development plan.  The JDT has the authority to approve Research and Development Plans.

(c)           The JDT shall review each approved Research and Development Plan at least once each year or at the request of any member, and shall decide whether or not to amend the Research and Development Plan, as the case may be.

(d)           If there is a tie vote in the JDT, or if the JDT is unable to resolve a dispute referred to the JDT, Infinity and MedImmune agree to exert all reasonable efforts to arrive at a mutually acceptable resolution, including a meeting between their CEO’s or a person designated by a CEO.  In the event that there is a tie vote or dispute as to a Project that is not resolved by the respective CEOs or their designees within thirty (30) days after submission to the CEOs, then such shall be resolved by binding arbitration in accordance with Exhibit A.

(e)           The JDT shall be responsible for providing advice with respect to and generally supervising research and development pursuant to all Research and Development Plans and for deciding disputes between the Parties with respect to work to be performed under any Research and Development Plan.  It is specifically understood, however, that the day-to-day

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management of the activities allocated to either Party under any Research and Development Plan shall be managed by such Party rather than the JDT.

(f)            The JDT shall keep accurate minutes of its deliberations which shall record all proposed decisions and all actions recommended or taken.  The Parties shall alternate responsibility for the preparation of the draft minutes on an annual basis.  Draft minutes shall be sent to all members of the JDT within fifteen (15) days after each meeting and shall be approved, if appropriate, or amended and approved as amended within thirty (30) days by a quorum of the JDT.  All records of the JDT shall at all times be available to both Infinity and MedImmune.

(g)           With respect to a Project, the JDT shall cease to have voting authority as to all Products of a Project upon Regulatory Approval for the first Product of such Project.  Thereafter, the JDT shall continue to exist as a sub-committee of the JCT, reporting to and advising the JCT with respect to development matters.  If either Party becomes an Opt-Out Party with respect to a Project, the JDT with respect to such Project shall cease to exist.

(h)           The chairperson of the JDT shall have the following roles and responsibilities: (a) to call meetings of the JDT, send notice of each such meeting and designate the time, date and place of each such meeting; (b) to convene or poll the members of the JDT by other permitted means; (c) to establish the agenda for each meeting of the JDT, subject to the right of any member of the JDT to add additional agenda items at any meeting; (d) to prepare comments to the draft minutes prepared by the secretary of the JDT and communicate with the secretary to finalize the draft minutes prior to circulation to all members of the JDT; and (e) to execute, along with the secretary of the JDT, the final minutes of the meetings of the JDT.  The chairperson shall alternate each calendar year between a member appointed by Infinity and a

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member appointed by MedImmune, with a member appointed by Infinity being the first chairperson for each JDT, and serving until the end of calendar year 2007.

(i)            Each Party shall provide the JDT with quarterly written reports regarding the status of the activities for the Project.

(j)            Each Party shall be responsible for all travel and related costs and expenses for its members, designees and non-JDT invitees to attend meetings of, and otherwise participate in, the JDT.

(k)           If a JDT member cannot attend a particular JDT meeting, such member may send a designate authorized to make decisions.

ARTICLE 4

RESEARCH, DEVELOPMENT AND REGULATORY

4.1           With respect to a Project each Party that has not become an Opt-Out Party agrees to perform the work assigned to that Party under a Research and Development Plan for that Project.  All such work will be conducted, in a professional manner and at a level of quality appropriate to major biotechnology companies.

4.2           Each Party shall prepare a written report prior to a scheduled meeting of the JDT with respect to the work performed by such Party under a Research and Development Plan and deliver such report to the JDT prior to the scheduled meeting.

4.3           In preparing a research and development plan and subsequent approval thereof by the JDT or JCT pursuant to this Agreement, work thereunder shall be assigned to a Party based upon the respective Parties ability to perform such activity.  Subject to the preceding sentence, the Parties contemplate that Infinity will have primary responsibility for activities involving

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expertise in development of small molecules such as lead identification and optimization, medicinal chemistry, preclinical development, early translational clinical development through initial evidence of safety and efficacy in humans, process chemistry and development and manufacturing scale-up, and that MedImmune shall have primary responsibility for pivotal clinical trials, for obtaining worldwide Regulatory Approval and for commercialization.

4.4           (a)           Infinity will file, own and maintain the INDs with respect to a given Product until the earlier of the end of a Phase II Clinical Trial meeting with the FDA or immediately prior to the initiation of the first Pivotal Trial in any country with respect to such Product.  At the earlier of the end of a Phase II Clinical Trial meeting with the FDA or immediately prior to initiation of the first Pivotal Trial for a given Product in any country Infinity will transfer all INDs with respect to such Product to MedImmune in all countries in which MedImmune is the Selling Party and thereafter the Selling Party in a country will file, own and maintain all INDs and Regulatory Approvals for such Product in such country.  The owner of the IND in the United States shall be responsible for the global product safety database for tracking safety issues with respect to the Product.

(b)           The owner of the IND shall within the time permitted under applicable regulations, file or cause to be filed with the FDA and any other applicable Regulatory Authority, all notices, assignments, documents or other materials required by the laws of the Territory to be filed in connection with such Product.  The owner of the IND shall be responsible for developing Product labeling, package inserts, imprinting and packaging data as appropriate, for the Product.  The owner of the IND shall be responsible for all regulatory compliance activities with respect to such Product.  The other Party shall provide any information and assistance reasonably requested by the owner of the IND for any regulatory filing, Product

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labeling development, and all regulatory compliance activities with respect to such Product.  The other Party agrees that time is of the essence with regard to these matters and will take all steps necessary to respond to the owner of the IND in a timely manner.  The owner of the IND agrees that, to the extent reasonably possible given such time constraints, prior to the Opt-Out Date for a Project, the other Party shall have a reasonable opportunity to review and comment upon regulatory filings and all substantive correspondence to or from the FDA or comparable Regulatory Authorities with respect to such Products of such Project and that the owner of the IND shall consider such comments in determining its activities with respect to interactions with the FDA and comparable Regulatory Authorities.  The Selling Party and the Non-Selling Party with respect to a Product shall have the right to attend meetings with Regulatory Authorities with respect to such Product, however, the Party that is not the owner of the IND shall participate in such meetings only as an observer.

(c)           On a country-by-country basis, the Selling Party shall have responsibility (subject to any responsibility provided to Infinity in any co-promotion agreement entered into pursuant to Section 6.4), to respond to questions and inquiries relating to the Product raised by health care professionals and customers and shall, if so requested by the Non-Selling Party, provide the Non-Selling Party with details of such questions and inquiries received and responses given.  The Selling Party will establish and implement effective procedures and mechanisms for responding to such questions and inquiries.

(d)           On a country-by-country basis, the Selling Party shall assume all responsibility (subject to any responsibility provided to Infinity in any co-promotion agreement entered into pursuant to Section 6.4) for all correspondence and communication with physicians and other health care professionals relating to the Product.  The Selling Party shall keep such

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records and make such reports as shall be reasonably necessary to document such communications in compliance with all applicable regulatory requirements and shall, if so requested by the Non-Selling Party, make available to the Non-Selling Party such records and reports.  The Non-Selling Party shall refer all such questions regarding the Products to the Selling Party in a timely manner.

(e)           Each Party shall promptly upon the Effective Date of this Agreement and thereafter at all times during the Term promptly disclose to the other Party all significant information of which it becomes aware, which it can legally disclose and which it reasonably believes will have a material commercial impact on the detailing, promotion, marketing and sale of the Product in accordance with this Agreement.

(f)            The owner of the IND shall have full responsibility for completing and filing the annual report and all other required reports in the Territory for the Product.

(g)           Effective upon filing of an IND for a Product, the owner of the IND shall be responsible for reporting adverse experiences and reactions with respect to the Product in conformance with all applicable laws, rules and regulations.   Each of Infinity and MedImmune shall send to the other, throughout such period, copies of all such adverse experience or reaction reports, with all “Serious” and “Unexpected” adverse experiences (and relevant government reporting forms) sent to the other Party no later than five (5) calendar days of such Party’s receipt, and all adverse experiences or reactions other than “Serious” or “Unexpected” adverse experiences (and relevant government reporting forms) sent to the other party no later than 30 calendar days after such Party’s receipt.  MedImmune and Infinity will develop pharmacovigilance procedures to comply with applicable regulations and orders of Regulatory Authorities.

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(h)           Notwithstanding anything else in this Section 4.4 to the contrary, during the period that the JDT has decision making authority for a Project, the actions of the owner of the IND pursuant to this Section 4.4 shall be consistent with the decisions of the JDT and the Research and Development Plan.

4.5           The Selling Party of a Product in the United States will be responsible for manufacturing or having manufactured such Product for worldwide use.  In the event that both Parties and/or their Affiliates are Selling Parties of a given Product in the Territory, the Parties shall establish a supply and quality agreement for such Product which shall provide for the equitable allocation of Product among countries in the Territory and other commercially reasonable terms.  If the Selling Party of a Product in the United States fails to meet its supply responsibilities, the Selling Party for such Product in any other country shall have the right to manufacture and have manufactured such Product for use and sale in such other country.

ARTICLE 5

LICENSES AND NON-COMPETE

5.1           (a)           For each Project, Infinity hereby grants to MedImmune, a worldwide and, subject to Section 5.4, sublicensable right and license that is co-exclusive with Infinity under the Infinity General Rights, Infinity Existing Rights and Collaboration Rights to make, have made, use, sell, offer to sell and import Product in the Field in accordance with the terms and conditions of this Agreement, and such license shall automatically terminate (i) for all Products of a Project as to which MedImmune becomes an Opt-Out Party effective as of the Opt-Out Date and (ii) in each country for each Product as to which MedImmune becomes the Non-Selling Party except for a non-exclusive license to make and have made Products in any country of the world for sale

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in a country where MedImmune is the Selling Party.  On a Project-by-Project basis, if MedImmune has not become an Opt-Out Party, Infinity agrees not to exercise any or grant any rights or licenses under any of the rights and licenses retained by Infinity under this Section 5.1(a) with respect to Product in any country of the Territory, except to the extent useful or necessary to perform its obligations or exercise its rights under this Agreement (including under any co-promotion agreement entered into pursuant to Section 6.4.) or to make and have made such Product in any country of the world for sale in a country where Infinity is the Selling Party.

(b)           For each Product in each country as to which Infinity is the Selling Party, MedImmune agrees to grant and hereby grants to Infinity a sublicensable right and license under Collaboration Rights and MedImmune General Rights that is co-exclusive with MedImmune to (i) make and have made such Product in any country of the world for sale in such countries, and (ii) use, sell, offer to sell and import such Products in such countries in the Field, in accordance with the terms and conditions of this Agreement, and such license shall automatically terminate for a Project (and for each Product in the Project) as to which Infinity becomes an Opt-Out Party effective as of the Opt-Out Date.  On a Project-by-Project basis, if Infinity has not become an Opt-Out Party, MedImmune agrees not to exercise any or grant any rights or licenses under any of the rights and licenses retained by MedImmune under this Section 5.1(b) with respect to a Product in any country of the Territory, as to which Infinity is the Selling Party, except to the extent useful or necessary to perform its obligations or exercise its rights under this Agreement including the rights and licenses granted to MedImmune under Section 5.1.

(c)           Any license granted under this Section 5.1 that is a sublicense shall be in accordance with the terms of the license agreement under which the sublicense is granted.

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5.2           (a)           For each Project, MedImmune hereby grants to Infinity a co-exclusive worldwide right and license under the MedImmune General Rights and Collaboration Rights to make, have made, use and import Product of said Project in the Field, but only to the extent useful or necessary to perform Infinity’s obligations or exercise its rights under a Research and Development Plan, which license shall automatically terminate for a Project (and for each Product in the Project) as to which Infinity becomes an Opt-Out Party effective as of the Opt-Out Date.  On a Project-by-Project basis, if Infinity has not become an Opt-Out Party, MedImmune agrees not to exercise any or grant any rights or licenses under any of the rights and licenses retained by MedImmune under this Section 5.2(a) to develop, market or sell a Product in any country of the Territory, except to the extent useful or necessary to perform its obligations or exercise its rights under this Agreement including the rights and licenses granted to MedImmune under Section 5.1.

(b)           Any license granted under this Section 5.2 that is a sublicense shall be in accordance with the terms of the license agreement under which the sublicense is granted.

5.3           [Purposely Omitted]

5.4           (a)           Either Party is free to grant sublicenses to its Affiliates with respect to the licenses granted to it by the other Party hereunder; provided , however , that such Party shall remain liable for all of its obligations hereunder and shall ensure that its Affiliates comply with all obligations of such Party hereunder.

(b)           In the event that MedImmune decides to grant a (sub)license to any Third Party with respect to sales of a Product in the United States or in one or more countries outside of the United States and at such time Infinity is a Non-Selling Party with respect to such Product in the United States or such other countries, as the case may be, MedImmune shall provide

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written notice to Infinity of such decision.  In the event that Infinity desires to become a Selling Party for such Products in the United States or in such other countries, Infinity shall provide written notice thereof to MedImmune within thirty (30) days after receipt of such notice.  The Parties thereafter shall discuss in good faith the ability of Infinity at such time to market and sell such Product in the United States or such one or more countries, as the case may be, in a manner that protects the profit interests of both Parties.  If the Parties do not reach agreement as to such issue, then Infinity shall have the right to submit such issue to arbitration pursuant to Exhibit A.

(c)           If Infinity does not provide MedImmune the notice of Section 5.4(b) or if Infinity does not submit the issue to arbitration within ten (10) days after notice that MedImmune does not agree with Infinity becoming the Selling Party or if in the arbitration it is determined that Infinity does not have such capabilities of Section 5.4(b), then MedImmune shall have the right to (sub)license such Products in such countries to a Third Party, subject to Infinity’s consent as to the entity who will be the Sublicensee which consent shall not be unreasonably withheld or delayed.

(d)           If MedImmune agrees that Infinity should be the Selling Party for such Products in the United States or such other countries or if it is determined in an arbitration that Infinity has the qualifications of Section 5.4(b) for becoming the Selling Party for such Products in the United States or such other countries, as the case may be, then with respect thereto, Infinity shall become the Selling Party (with the right to sublicense commercialization rights with the consent of MedImmune, such consent not to be unreasonably withheld) and MedImmune the Non-Selling Party.

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(e)           For Europe, if MedImmune proposes to grant a (sub)license for a plurality of countries in Europe, then Infinity’s rights under this Section 5.4 (except Section 5.4(a)) shall require that Infinity meets the qualifications to become a Selling Party for all of such countries.

(f)            If Infinity becomes the Selling Party in any country, MedImmune will, transfer all Promotional Materials, customer lists and other information in its possession related to the promotion of the applicable Product in such country to Infinity and perform such services as Infinity may reasonably request with the goal of effecting a smooth transition of the promotion duties previously performed by MedImmune.  The Parties shall equally share the expense thereof.

(g)           If Infinity becomes the Selling Party in a country for a Product, to the extent legally permitted, MedImmune shall, with respect to the applicable Product in such country, transfer to Infinity any and all INDs, Regulatory Approvals, regulatory filings and price approvals.

(h)           If Infinity becomes the Selling Party in the United States for all Products of a Project, Infinity shall assume MedImmune’s right to cast the deciding vote and appoint the Chairman of the Joint Commercialization Team for such Project pursuant to Section 6.2.

5.5           (a)           Neither Party shall, and each Party shall ensure that its Affiliates shall not, develop, market or sell a Product except in accordance with the terms and conditions of this Agreement.

(b)           If a Party becomes an Opt-Out Party with respect to a Project, then the obligations of Section 5.5(a) with respect to Products of such Project shall terminate two (2) years after the Opt-Out Date for such Project other than those that (i) embody or use Collaboration Rights or Infinity Existing Rights or (ii) contain an Active Pharmaceutical

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Ingredient for a Product that was researched and/or developed prior to the applicable Opt-Out Date.

(c)           If either Party or any of its Affiliates signs a definitive agreement with respect to a merger or acquisition by operation of which such Party or its Affiliate would (i) acquire a Product or (ii) be acquired by or merge with a Third Party who has a Product (a Product described in clause (i) or (ii), an “ Acquired Pr