Exhibit 10.2

EXECUTION VERSION

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

COLLABORATION AND LICENSE AGREEMENT

BY AND BETWEEN

INFINITY PHARMACEUTICALS, INC.

AND

ABBVIE INC.

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TABLE OF CONTENTS

 

ARTICLE 1. DEFINITIONS      1    ARTICLE 2. MANAGEMENT OF COLLABORATIVE
ACTIVITIES      28   

2.1.

  Overview of Collaboration      28   

2.2.

  Joint Development Committee      29   

2.3.

  Joint Commercialization Committee      31   

2.4.

  Medical Affairs Committee      32   

2.5.

  Working Groups      33   

2.6.

  Membership      34   

2.7.

  Meetings of the Committees and Working Groups      35   

2.8.

  Discontinuation of Participation on a Committee      35   

2.9.

  Decision-Making      35   

2.10.

  Alliance Managers      38    ARTICLE 3. LICENSE GRANTS      38   

3.1.

  Infinity Grants      38   

3.2.

  AbbVie Grants      40   

3.3.

  Provision of Information      41   

3.4.

  Joint Patent Rights      41   

3.5.

  Blocking Third Party Intellectual Property      41   

3.6.

  Sublicensing and Subcontracting      43   

3.7.

  Exclusivity Covenants      44   

3.8.

  Reservation of Rights      45    ARTICLE 4. DEVELOPMENT      46   

4.1.

  GDP; Amendments; Development Responsibilities      46   

4.2.

  Medical Affairs Activities      49   

4.3.

  Development Efforts; Manner of Performance; Reports      51   

4.4.

  Regulatory Submissions and Regulatory Approvals      53   

4.5.

  Pharmacovigilance      54   

4.6.

  Costs of Joint Development      55   

4.7.

  Development Records      57    ARTICLE 5. COMMERCIALIZATION      57   

5.1.

  Commercialization Efforts      57   

5.2.

  Manner of Performance      58   

5.3.

  Commercialization Plans      59   

 

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5.4.

  Global Branding Strategy      60   

5.5.

  Commercialization Responsibilities for the US Territory      60   

5.6.

  Commercialization in the Ex-US Territory      62   

5.7.

  Sales Representatives      62   

5.8.

  Co-Promotion in the United States      62    ARTICLE 6. MANUFACTURE AND SUPPLY
     63   

6.1.

  Manufacture      63   

6.2.

  Manufacturing Working Group      64    ARTICLE 7. FINANCIAL PROVISIONS      64
  

7.1.

  Upfront and Milestone Payments      64   

7.2.

  Net Profit or Loss      64   

7.3.

  Royalties      65   

7.4.

  Reconciliation of Costs Incurred in or for the Ex-US Territory      68   

7.5.

  Financial Audits      68   

7.6.

  Tax Matters      69   

7.7.

  Currency Exchange      71   

7.8.

  Blocked Payments      72   

7.9.

  Late Payments      72    ARTICLE 8. INTELLECTUAL PROPERTY OWNERSHIP,
PROTECTION AND RELATED MATTERS      72   

8.1.

  Ownership of Inventions      72   

8.2.

  Prosecution and Maintenance of Patent Rights      74   

8.3.

  Third Party Infringement      76   

8.4.

  Patent Term Extensions      79   

8.5.

  Patent Marking      79   

8.6.

  Orange Book Listings      79   

8.7.

  Trademarks      80    ARTICLE 9. CONFIDENTIALITY AND PUBLICITY      82   

9.1.

  Confidential Information      82   

9.2.

  Residual Knowledge Exception      83   

9.3.

  Publicity      83   

9.4.

  Publications      84   

9.5.

  Public Filing of this Agreement      85   

 

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ARTICLE 10. REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS      85   

10.1.

  Mutual Representations and Warranties      85   

10.2.

  Additional Representations and Warranties of Infinity      86   

10.3.

  Additional Representations and Warranties of AbbVie      89   

10.4.

  No Debarment      89   

10.5.

  No Warranties      90   

10.6.

  Covenants with Respect to Infinity Third Party Agreements      90   

10.7.

  Covenants with Respect to AbbVie Third Party Agreements      92   

10.8.

  Insurance      93    ARTICLE 11. INDEMNIFICATION      94   

11.1.

  General Indemnification By Infinity      94   

11.2.

  General Indemnification By AbbVie      94   

11.3.

  Claims for General Indemnification      94   

11.4.

  Conduct of Product Liability Actions      95    ARTICLE 12. TERM AND
TERMINATION      96   

12.1.

  Term      96   

12.2.

  Early Termination      96   

12.3.

  Effects of Termination      99    ARTICLE 13. ALTERNATIVE DISPUTE RESOLUTION
     105    ARTICLE 14. MISCELLANEOUS      109   

14.1.

  Change of Control of the Parties      109   

14.2.

  Assignment; Successors      109   

14.3.

  Export Control      110   

14.4.

  Choice of Law      110   

14.5.

  Notices      111   

14.6.

  Severability      111   

14.7.

  Integration      112   

14.8.

  English Language      112   

14.9.

  Waivers and Amendments      112   

14.10.

  Independent Contractors; No Agency      112   

14.11.

  Execution in Counterparts; Facsimile Signatures      112   

14.12.

  No Consequential or Punitive Damages      113   

14.13.

  Performance by Affiliates      113   

14.14.

  Force Majeure      113   

14.15.

  No Third Party Beneficiary Rights      114   

14.16.

  Non-exclusive Remedy      114   

 

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14.17.

  Interpretation      114   

14.18.

  Further Assurances      115   

14.19.

  Ambiguities; No Presumption      115   

14.20.

  Records Generally      115   

LIST OF SCHEDULES

 

Schedule 1.40    Exclusivity Compounds Schedule A    [**] Description
Schedule 3.5.1    Non-Royalty Payments under Existing Infinity Third Party
Agreements Schedule 4.6.1    Pre-Execution Date Development Costs Schedule 7   
Financial Terms Schedule 10.2.7    Litigation    LIST OF EXHIBITS    Exhibit A
   Financial Exhibit Exhibit B    Infinity Patent Rights Exhibit C    Global
Development Plan Exhibit D    IPI-145 Exhibit E    Press Release Exhibit F   
AbbVie Combination Compound

 

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COLLABORATION AND LICENSE AGREEMENT

This Collaboration and License Agreement (this “Agreement”) is made and
effective as of the 2nd day of September, 2014 (the “Execution Date”) by and
between Infinity Pharmaceuticals, Inc., a Delaware corporation, with offices at
780 Memorial Drive, Cambridge, MA 02139, USA (“Infinity”) and AbbVie Inc., a
Delaware corporation, with offices at 1 North Waukegan Road, North Chicago, IL
60064 (“AbbVie”).

INTRODUCTION

WHEREAS, Infinity has certain rights to and is developing the Licensed Compounds
and Products (each as defined below);

WHEREAS, Infinity and AbbVie believe that a collaboration and license
arrangement between the Parties regarding the Products would be desirable and
that participation of both Parties in this arrangement would be of economic
benefit to both Parties; and

WHEREAS, Infinity and AbbVie therefore desire to provide for the development,
manufacture and commercialization of the Products on and subject to the terms
and conditions set forth herein.

NOW, THEREFORE, for and in consideration of the mutual covenants contained
herein, Infinity and AbbVie hereby agree as follows:

ARTICLE 1.

DEFINITIONS

As used in this Agreement, the following terms shall have the meanings set forth
below:

1.1. “AbbVie Combination Compound” means the compound further described in
Exhibit F.

1.2. “AbbVie Intellectual Property” means AbbVie Know-How and AbbVie Patent
Rights, collectively.

1.3. “AbbVie Know-How” means all Know-How Controlled by AbbVie or any of its
Affiliates, as of the Execution Date or during the Term, that is not generally
known and is necessary or useful for the Development, Manufacture or
Commercialization of any Licensed Compound or Product in the Field, including
the rights of AbbVie or its Affiliates in AbbVie Sole Inventions and Joint
Inventions, but excluding any Know-How to the extent Covered by published AbbVie
Patent Rights.

1.4. “AbbVie Patent Rights” means all Patent Rights Controlled by AbbVie or any
of its Affiliates, as of the Execution Date or during the Term, that are
necessary or useful for the Development, Manufacture or Commercialization of any
Licensed Compound or Product in the Field, including the rights of AbbVie or its
Affiliates in Joint Patent Rights and in Patent Rights covering AbbVie Sole
Inventions.

 

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1.5. “AbbVie Third Party Agreements” means (a) any Third Party agreement
existing prior to or as of the Effective Date pursuant to which AbbVie Controls,
or with the consent of the applicable Third Party would Control, any Know-How
included, or that would be included, in AbbVie Know-How or Patent Rights
included, or that would be included, in AbbVie Patent Rights, and (b) any Third
Party agreement entered into by AbbVie pursuant to Section 3.5; each such
agreement as it may be amended from time to time.

1.6. “AbbVie Withholding Tax Action” means any action taken by AbbVie, an AbbVie
Affiliate, or successor that both (a) shifts to a foreign Affiliate of AbbVie,
its successor or Sublicensee any obligation to make a payment to Infinity under
this Agreement and (b) results in a net increase of Withholding Tax on such
payment.

1.7. “Accounting Standards” means, with respect to a Person, generally accepted
accounting principles as practiced in the United States or applicable
international standards followed by such Person.

1.8. “Action” means any claim, action, cause of action or suit (whether in
contract or tort or otherwise), litigation (whether at law or in equity, whether
civil or criminal), controversy, assessment, arbitration, investigation,
hearing, charge, complaint, demand, notice or proceeding of, to, from, by or
before any Governmental Authority.

1.9. “Adverse Event” means any adverse event associated with the use of a drug
in humans, whether or not considered drug related, including (a) an adverse
event occurring in the use of a drug product in a clinical investigation, (b) an
adverse event occurring in the course of the use of a drug product in
professional practice, (c) an adverse event occurring from drug overdose whether
accidental or intentional, (d) an adverse event occurring from drug abuse,
(e) an adverse event occurring from drug withdrawal or (f) and any failure of
expected pharmacological action.

1.10. “Affiliate” means with respect to any Person, any Person controlling,
controlled by or under common control with such first Person. For purposes of
this Section 1.10, “control” means (a) 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 of such Person (or if the jurisdiction where such Person
is domiciled prohibits foreign ownership of such entity, the maximum foreign
ownership interest permitted under such Laws; provided, that such ownership
interest provides actual control over such Person), (b) status as a general
partner in any partnership, or (c) the possession, directly or indirectly, of
the power to direct, or cause the direction of, the management or policies of
such Person, whether through the ownership of voting securities, by contract or
otherwise.

1.11. “Blocking Third Party Intellectual Property” means, with respect to a
Licensed Compound or Product in any country, Patent Rights or Know-How in such
country owned or controlled by a Third Party (but not then included in Infinity
Intellectual Property or AbbVie Intellectual Property) that Cover (with respect
to Patent Rights), or are necessary or, where explicitly provided in this
Agreement, useful to Develop, Manufacture or Commercialize (with respect to such
Know-How owned or Controlled by a Third Party), such Licensed Compound or
Product in such country, to the extent such Development, Manufacture or
Commercialization is contemplated in such country.

 

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1.12. “Blocking Third Party Intellectual Property Costs” means Out-of-Pocket
Costs, comprising upfront payments, milestones, royalties, and any portion of
other license fees or other payments arising out of the Development,
Manufacturing or Commercialization of a Product and paid to a Third Party who
owns or controls Blocking Third Party Intellectual Property to license or
acquire the relevant Patent Rights or Know-How for the Development, Manufacture
or Commercialization of a Product in the Field in accordance with Section 3.5.

1.13. “Business Day” means any day other than a Saturday or a Sunday on which
the banks in New York, New York are open for business.

1.14. “Calendar Quarter” means each of the three (3) month periods ending on
March 31, June 30, September 30, and December 31 of any Calendar Year, or the
applicable portion of such period.

1.15. “Calendar Year” means each twelve (12) month period commencing on
January 1, and ending on December 31, or the applicable portion of such period;
provided, that the first Calendar Year commences on the Effective Date and ends
on December 31, 2014.

1.16. “Change of Control” means, with respect to a Party, any of the following
events occurring after the Effective Date:

(a) any “person” or “group” (as such terms are defined below) (a) is or becomes
the “beneficial owner” (as defined below), directly or indirectly, of shares of
capital stock or other interests (including partnership interests) of such Party
then outstanding and normally entitled (without regard to the occurrence of any
contingency) to vote in the election of the directors, managers or similar
supervisory positions (“Voting Stock”) of such Party representing fifty percent
(50%) or more of the total voting power of all outstanding classes of Voting
Stock of such Party or (b) has the power, directly or indirectly, to elect a
majority of the members of the Party’s board of directors, or similar governing
body (“Board of Directors”); or

(b) such Party enters into a merger, consolidation or similar transaction with
another Person (whether or not such Party is the surviving entity), and as a
result of such merger, consolidation or similar transaction (a) the members of
the Board of Directors of such Party immediately prior to such transaction
constitute less than a majority of the members of the Board of Directors of such
Party or such surviving Person immediately following such transaction or (b) the
Persons that beneficially owned, directly or indirectly, the shares of Voting
Stock of such Party immediately prior to such transaction cease to beneficially
own, directly or indirectly, shares of Voting Stock of such Party representing
at least a majority of the total voting power of all outstanding classes of
Voting Stock of the surviving Person in substantially the same proportions as
their ownership of Voting Stock of such Party immediately prior to such
transaction; or

(c) such Party sells or transfers to any Third Party, in one (1) or more related
transactions, properties or assets representing all or substantially all of such
Party’s consolidated total assets to which this Agreement relates; or

(d) the holders of capital stock of such Party approve a plan or proposal for
the liquidation or dissolution of such Party.

 

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For the purpose of this definition of Change of Control: (a) “person” and
“group” have the meanings given such terms under Section 13(d) and 14(d) of the
United States Securities Exchange Act of 1934 (the “Exchange Act”) and the term
“group” includes any group acting for the purpose of acquiring, holding or
disposing of securities within the meaning of Rule 13d-5(b)(1) under the said
Act; (b) a “beneficial owner” shall be determined in accordance with Rule 13d-3
under the aforesaid Act; and (c) the terms “beneficially owned” and
“beneficially own” shall have meanings correlative to that of “beneficial
owner.”

1.17. “Clinical Investigation Laws” means Laws relating to human clinical
investigations, including 21 C.F.R. Parts 50, 54, 56 and 312, and GCP.

1.18. “Clinical Study” means any Phase I Clinical Study, Phase II Clinical
Study, Phase III Clinical Study, Phase IIIb Clinical Study or Phase
IV/Post-Approval Clinical Study, or any other study in which human subjects or
patients are dosed with a drug, whether approved or investigational, and
including applicable Investigator Sponsored Clinical Studies.

1.19. “CMC Development” means the following chemistry, manufacturing and control
activities within Manufacturing: test method development and validation,
stability testing, process development, process validation, process scale-up,
formulation development, delivery system development, quality assurance and
quality control development, and other related activities.

1.20. “Code” means the Internal Revenue Code of 1986, as amended from time to
time (or any corresponding provisions of succeeding law).

1.21. “Combination Clinical Study” means [**], as such Clinical Studies may be
revised, modified or amended in accordance with the terms of this Agreement.

1.22. “Combination Product” means a Product that contains a Licensed Compound as
an active pharmaceutical ingredient together with one or more other active
pharmaceutical ingredients in therapeutically relevant doses and is sold either
as a fixed dose combination or as separate doses in a single package.

1.23. “Commence” or “Commencement” means, when used to describe a Clinical Study
of a Product, the first dosing of the first human subject with such Product in
such Clinical Study.

1.24. “Commercialization” or “Commercialize” means any and all activities
directed to the preparation for sale of, offering for sale of, or sale of a
Licensed Compound or Product, including activities to obtain and maintain
Pricing and Reimbursement Approvals, secure and maintain market access and
reimbursement, market, promote, distribute, and import a pharmaceutical or
diagnostic product. For clarity, Commercialization shall not include Research,
Development, Manufacture or Medical Affairs Activities.

1.25. “Commercialization Plan” means (a) with respect to the Products in the US
Territory, the US Commercialization Plan and (b) with respect to the Products in
the Ex-US Territory, the Ex-US Commercialization Plan.

 

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1.26. “Commercialization Support Data” means health economics and outcomes
research (“HECOR”) data from patient reported outcomes, prospective
observational studies and retrospective observational studies, and economic
models and reimbursement dossiers.

1.27. “Committee” means the JSC, JDC, JCC or JMAC.

1.28. “Confidential Information” means (a) all trade secrets or confidential or
proprietary information or tangible materials of the disclosing Party or its
Affiliates provided or disclosed to the other Party or any of its Affiliates
pursuant to this Agreement or any Related Agreement, (b) “Confidential
Information” (as defined in the Prior CDA) that was disclosed by a Party or any
of its Affiliates to the other Party or any of its Affiliates under the Prior
CDA, and (c) the terms and conditions of this Agreement; provided, however, that
Confidential Information shall not include information that:

(i) has been published by a Third Party or otherwise is or hereafter becomes
part of the public domain by public use, publication, general knowledge or the
like through no wrongful act, fault or negligence on the part of the receiving
Party or its Affiliates;

(ii) has been in the receiving Party’s or its Affiliates possession prior to
disclosure by the disclosing Party without any obligation of confidentiality
with respect to such information (as evidenced by the receiving Party’s or such
Affiliate’s written records or other competent evidence);

(iii) is subsequently received by the receiving Party or its Affiliate from a
Third Party without restriction and without breach of any agreement between such
Third Party and the disclosing Party;

(iv) that is generally made available to Third Parties by the disclosing Party
without restriction on disclosure; or

(v) has been independently developed by or for the receiving Party or its
Affiliates without reference to, or use or disclosure of, the disclosing Party’s
Confidential Information (as evidenced by the receiving Party’s or such
Affiliate’s written records or other competent evidence);

provided, further, however, that clauses (ii) through (v) above cannot be
applied to the terms and conditions of this Agreement.

Specific aspects or details of Confidential Information shall not be deemed to
be within the public domain or in the possession of the receiving Party merely
because the Confidential Information is embraced by more general information in
the public domain or in the possession of the receiving Party. Further, any
combination of Confidential Information shall not be considered in the public
domain or in the possession of the receiving Party merely because individual
elements of such Confidential Information are in the public domain or in the
possession of the receiving Party unless the combination and its principles are
in the public domain or in the possession of the receiving Party.

 

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Joint Know-How shall be deemed to be the Confidential Information of both
Parties, and both Parties shall be deemed to be the receiving Party and
disclosing Party with respect thereto.

All Regulatory Filings owned by a Regulatory Owner shall be deemed to be the
Confidential Information of such Regulatory Owner and such Regulatory Owner
shall be deemed to be the disclosing Party and the other Party shall be deemed
to be the receiving Party with respect thereto.

1.29. “Control” or “Controlled” means, with respect to any Know-How, Patent
Right, other intellectual property right, compound or product, the legal
authority or right (whether by ownership, license (other than a license granted
pursuant to this Agreement) or otherwise) of a Party or its relevant Affiliate,
to grant access, a license or a sublicense of or under such Know-How, Patent
Right, intellectual property right, compound or product to the other Party, to
the extent contemplated by this Agreement, without breaching the terms of any
agreement with a Third Party, or misappropriating the proprietary or trade
secret information of a Third Party; provided, however, that Know-How, Patent
Rights or other intellectual property rights subject to a Third Party payment
obligation as a result of the grant of a license to the other Party or arising
out of the practice or use of such Know-How, Patent Rights, other intellectual
property right, compound or product by a Party hereunder shall only be deemed to
be “Controlled” by a Party if such payment obligations are included in the
Blocking Third Party Intellectual Property Costs or Infinity Third Party
Agreement Payments, as applicable (other than Know-How, Patent Rights and/or
other intellectual property rights granted or arising under or pursuant to the
Intellikine Agreement, which shall, notwithstanding anything herein to the
contrary, be deemed “Controlled” by Infinity for all purposes hereunder
regardless whether any related payment obligations are included in the Blocking
Third Party Intellectual Property Costs or Infinity Third Party Agreement
Payments hereunder).

1.30. “Co-Promote” or “Co-Promotion” means, with respect to a Product in the US,
the joint marketing and promotion of such Product (including performing Sales
Calls) in the US by both Parties or their respective Affiliates under the same
Product Trademark(s) and in accordance with this Agreement and the US
Commercialization Plan.

1.31. “Cover,” “Covering” or “Covered” means, when referring to a compound,
product, invention or other Know-How: (a) with respect to a patent, that, in the
absence of a license granted to a Person under a claim included in such patent,
the practice by such Person of a specified activity with respect to such
compound or product, or the practice by such Person of such invention or the use
by such Person of such Know-How, would infringe such claim, or (b) with respect
to a patent application, that, in the absence of a license granted to a Person
under a claim included in such patent application, the practice by such Person
of a specified activity with respect to such compound or product, or the
practice by such Person of such invention or the use by such Person of such
Know-How, would infringe such claim if such patent application were to issue as
a patent.

1.32. “Data” means any and all data, results, pharmacology data, medicinal
chemistry data, preclinical data, clinical data (including investigator reports
(both preliminary and final), statistical analysis, expert opinions and reports,
safety and other electronic databases), in any and all forms, including files,
reports, raw data, source data (including patient medical records and

 

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original patient report forms, but excluding patient-specific data to the extent
required by applicable Laws) and the like, in each case generated during the
Development, Manufacture or Commercialization of any Licensed Compound or
Product, including Commercialization Support Data.

1.33. “Development” or “Develop” means non-clinical and clinical drug or
diagnostic development activities, including drug metabolism and
pharmacokinetics, translational research, toxicology, pharmacology, test method
development and stability testing, process and packaging development and
improvement, process validation, process scale-up, formulation development,
delivery system development, quality assurance and quality control development,
statistical analysis, conduct of Clinical Studies (but excluding any Phase IIIb
or Phase IV/Post-Approval Clinical Study that is not required to obtain or
maintain Regulatory Approval), regulatory affairs (including preparation for
Regulatory Approval Application submission and other submission-related
activities), and Regulatory Approval and Clinical Study regulatory activities
(excluding regulatory activities directed to obtaining Pricing and Reimbursement
Approvals). Development includes use and importation of the relevant compound or
product to conduct such Development activities (with related importation and
transportation costs only counted once as Development Costs and not double
counted elsewhere). Development shall not include Research, Commercialization or
Medical Affairs Activities.

1.34. “Development Budget” means the budget for conducting Development (and
related Manufacturing) of Licensed Compounds and Products pursuant to and
included in the GDP for the relevant Calendar Years in accordance with
Section 4.1.1.

1.35. “Development Costs” means Development FTE Costs and Out-of-Pocket Costs,
recorded as an expense in accordance with Accounting Standards, reasonably
incurred and specifically identifiable by the Parties and their Affiliates in
Developing the Products (and related Manufacturing activities) in the Field, in
each case to the extent incurred in accordance with this Agreement, the GDP and
the Development Budget, including:

(a) “Development FTE Costs,” which means the product of the number of
Development FTEs times the FTE Rate, where a “Development FTE” means a
scientific, regulatory, technical, legal, finance or other individual engaged
full time for one (1) Calendar Year (consisting of at least a total of [**]
hours per Calendar Year) in performing or supporting Development (and related
Manufacturing) activities under the GDP. No additional payment shall be made
with respect to any individual who works more than [**] hours per Calendar Year
and any individual who devotes less than [**] hours per Calendar Year (or such
other number as may be agreed by the JDC or JSC, as applicable) shall be treated
as a Development FTE on a pro rata basis based upon the actual number of hours
worked divided by [**];

(b) all Out-of-Pocket Costs for conducting Clinical Studies of Products (to the
extent not captured below);

(c) Out-of-Pocket Costs (if not otherwise captured above) of Manufacturing or
having Manufactured clinical supplies for such efforts as set forth in the GDP,
including, as applicable: (i) the Supply Price of clinical supply of the
Products; (ii) costs and expenses incurred to purchase, package or distribute
Third Party comparator or Third Party combination drugs or devices; and
(iii) costs and expenses of disposal of clinical samples;

 

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(d) Out-of-Pocket Costs representing fees incurred in connection with Regulatory
Filings with respect to Products in the Field;

(e) Out-of-Pocket Costs (if not otherwise captured above) associated with pre-
and post-approval commitments mandated by Governmental Authorities, to the
extent incurred with respect to Products;

(f) Out-of-Pocket Costs (if not otherwise captured above) incurred in connection
with CMC Development or qualification and validation of manufacturers, and if a
Party or an Affiliate of a Party is established as a supplier, the Out-of-Pocket
Costs to do so, including the Parties’ costs for transfer of process and
manufacturing technology and analytical methods, scale up, process and equipment
validation, and initial manufacturing licenses, approvals and inspections;

(g) Out-of-Pocket Costs (if not otherwise captured above) associated with
activities related to pharmacovigilance, including establishing, updating and
maintaining a global safety database for Products;

(h) Out-of-Pocket Costs (if not otherwise captured above) associated with
Diagnostic Products, to the extent applicable to and used in the Development of
a Product;

(i) Shared Patent Prosecution Costs; and

(j) any other Out-of-Pocket Costs incurred for activities specified in the GDP
and included in the Development Budget.

Development Costs shall exclude all of the payments set forth in Section 7.1,
all payments pursuant to Sections 7.2 and 7.3 and Allowable Expenses as defined
in the Financial Exhibit and capital expenditures, and costs attributable to
general corporate activities, executive management, investor relations, treasury
services, business development, corporate government relations, external
financial reporting and other overhead activities.

1.36. “Development Threshold” means an aggregate of US$667,000,000 in
Development Costs, but excluding Combination Study Costs.

1.37. “Diagnostic Product” means, with respect to a Product, any biomarker or
diagnostic assay or test to determine information regarding a subject or patient
that is correlated with patient populations that do or do not respond to or to
optimize treatment with such Product.

1.38. “Diligent Efforts” means, with respect to the performance of Development,
Medical Affairs Activities, Commercialization, or Manufacturing activities with
respect to the Licensed Compound or a Product by a Party, the carrying out of
such activities using the level of effort required to carry out an obligation in
a sustained, active and diligent manner consistent with such level of effort
that companies in the pharmaceutical industry generally devote at the same stage
of development or commercialization, as applicable, for their own internally
developed

 

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pharmaceutical products in a similar therapeutic or disease area with similar
market potential at a similar stage of product life, taking into account the
regulatory structure involved, the anticipated profitability of the Product and
other relevant factors, including safety and efficacy of the Product, the
potential for additional indications, the level of competition in the market for
the Product generally or for any particular indication, changes in clinical or
regulatory strategy justified by compliance with the requirements of regulatory
feedback from any Regulatory Authority, failed or inconclusive clinical studies,
discovery of unanticipated toxicity or any significant adverse event or
condition relating to the safety or efficacy of a Product, significant adverse
changes in the targeted market conditions which affect the market potential of a
Product, and the need for additional Clinical Studies to achieve appropriate
labeling of a Product. “Diligent Efforts” shall be determined on a
country-by-country basis, except that the Party may consider the impact of its
efforts and resources expended with respect to any country on any other country.

1.39. “DOJ” means the United States Department of Justice.

1.40. “Drug Regulation Laws” means Laws regulating drugs and pharmaceutical
products, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et.
seq. (the “FFDCA”), the Prescription Drug Marketing Act of 1987, the federal
Controlled Substances Act, 21 U.S.C. §801 et. seq., and any guidance documents
and policy and procedural manuals issued by the FDA.

1.41. “Early Access Program” means any program to provide patients with a
Product prior to Regulatory Approval in any country in the Territory, including
treatment INDs/protocols, named patient programs and compassionate use programs.
For clarity, an Early Access Program with respect to a Product may continue to
be performed following Regulatory Approval of such Product, and costs may
continue to be incurred in accordance with the performance of such Early Access
Program after Regulatory Approval.

1.42. “Effective Date” means the Execution Date.

1.43. “EMA” means the European Medicines Agency or any successor agency thereto.

1.44. “European Union” or “EU” means the countries of the European Union as
constituted on the Execution Date and as it may be expanded or contracted from
time to time after the Execution Date; provided that the EU shall always be
deemed to include the United Kingdom, France, Germany, Italy and Spain.

1.45. “Exclusivity Compound” means a PI3K d/g dual inhibitor meeting the
criteria set forth in Schedule 1.40.

1.46. “Excluded Claim” means a dispute, controversy or claim that concerns the
validity, enforceability or infringement of a Patent Right, trademark or
copyright.

1.47. “Executive Officers” means (a) with respect to Infinity, the Chief
Executive Officer of Infinity (or a senior executive officer of Infinity
designated by Infinity’s Chief Executive Officer), and (b) with respect to
AbbVie, the Chief Executive Officer (or a senior executive officer of AbbVie or
its Affiliates designated by AbbVie’s Chief Executive Officer). If the position
of any of the Executive Officers identified in this Section 1.47 no longer
exists due to a corporate

 

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reorganization, corporate restructuring or the like that results in the
elimination of the identified position, the applicable title of the Executive
Officer set forth herein shall be replaced with the title of another executive
officer with responsibilities and seniority comparable to the eliminated
Executive Officer, and the relevant Party shall promptly provide notice of such
replacement title to the other Party.

1.48. “Existing Infinity Third Party Agreements” means (a) the Intellikine
Agreement (b) the MICL Agreement, and (c) the Purdue Agreement; each such
agreement as it may be amended from time to time.

1.49. “Existing Infinity Third Party Agreement Payments” means all payments
under Existing Infinity Third Party Agreements incurred or paid after the
Execution Date arising out of Development activities or Commercialization
activities with respect to any Licensed Compound or Product under this
Agreement, but excluding any royalty payments due by Infinity to Intellikine
under the Intellikine Agreement or that may be due to Intellikine under any
other agreement existing as of the Effective Date.

1.50. “Ex-US Commercialization Plan” means the commercialization plan with
respect to the Commercialization of the Products in the Ex-US Territory for the
relevant Calendar Years in accordance with Section 5.3.1, including an overall
strategy for Commercialization and a tactical plan to accomplish such strategy,
as developed, approved and amended in accordance with this Agreement and
consistent with the Global Branding Strategy.

1.51. “Ex-US Territory” means worldwide excluding the US Territory.

1.52. “Exploit” or “Exploitation” means to make, have made, import, export, use,
have used, sell, have sold, or offer for sale, including to Develop,
Commercialize, register, modify, enhance, improve, Manufacture, have
Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise
dispose of Products.

1.53. “FDA” means the United States Food and Drug Administration or any
successor agency thereto.

1.54. “Field” means with respect to the Licensed Compound, all human and
non-human diagnostic, prophylactic, and therapeutic uses in cancer, including
cancer specifically associated with blood-forming tissue, such as the bone
marrow, or in the cells of the immune system, including leukemia, lymphoma and
multiple myeloma.

1.55. “Financial Exhibit” means Exhibit A attached hereto, as may be amended
from time to time by mutual written agreement of the Parties.

1.56. “First Commercial Sale” means, with respect to a Product in a country, the
first sale for monetary value for use or consumption by the end user of such
Product in such country after the receipt of the Marketing Authorization for
such Product has been obtained in such country. Sales prior to receipt of
Marketing Authorization for such Product, such as, pursuant to any Early Access
Programs, so-called “treatment IND sales,” “named patient sales,” and
“compassionate use sales,” shall not be construed as a First Commercial Sale.

 

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1.57. “First Sale” means, with respect to a Product in a country, the first sale
of such Product to a Third Party in such country after the receipt of the
Marketing Authorization for such Product in such country, if such Marketing
Authorization is required, or, if Marketing Authorization is not required, such
as, for example, pursuant to any Early Access Programs, so-called “treatment IND
sales,” “named patient sales,” and “compassionate use sales,” upon the first
such sale.

1.58. “FTC” means the United States Federal Trade Commission.

1.59. “FTE” means the equivalent of the work of one (1) employee full time for
one (1) Calendar Year (consisting of at least a total of [**] hours per Calendar
Year) of work.

1.60. “FTE Rate” means, with respect to Development FTEs, [**] United States
Dollars ($[**]), and for all other FTEs, [**] United States Dollars ($[**]),
which rates will increase or decrease January 1 of each Calendar Year (starting
with January 1, 2015) in accordance with the percentage year-over-year increase
or decrease in (A) with respect to the U.S., the Consumer Price Index – Urban
Wage Earners and Clerical Workers, US City Average, All Items, 1982-84 = 100,
published by the United States Department of Labor, Bureau of Labor Statistics
(or its successor equivalent index) over the twelve (12) month period preceding
each such January 1, and (B) with respect to any other country, the equivalent
index calculated by the relevant Governmental Authority in such country.

1.61. “Generic Entry” means, with respect to a Product and country, the first
sale of a Generic Product.

1.62. “Generic Product” means, with respect to a Product and country, any
pharmaceutical product that (a) is sold by a Third Party under a Regulatory
Approval Application granted by a Regulatory Authority to such Third Party,
which Third Party is not a licensee or Sublicensee of a Party or its Affiliates,
or any of their licensees or Sublicensees, and has not obtained such Product
from a chain of distribution including a Party, its Affiliates or any of their
licensees or Sublicensees, (b) contains the applicable Licensed Compound as an
active pharmaceutical ingredient, and (c) is approved in reliance, in whole or
in part, on the prior approval of such Product as determined by the applicable
Regulatory Authority (pursuant to 21 U.S.C. 355(b)(2), 21 U.S.C. 355(j), a
separate Regulatory Approval Application, compendia listing, other drug approval
application or otherwise, including foreign equivalents of the foregoing). A
Product licensed or produced by one of the Parties or their respective
Affiliates (i.e., an authorized generic product) will not constitute a Generic
Product.

1.63. “GCP” or “Good Clinical Practice” means all applicable then-current
standards for the design, conduct, performance, monitoring, auditing, recording,
analyses and reporting of Clinical Studies, including, as applicable, (a) as set
forth in the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use Harmonised Tripartite
Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines
for good clinical practice for trials on medicinal products in the Territory,
(b) the Declaration of Helsinki (2013) as last amended at the 64th World Medical
Association in October 2013 and any further amendments or clarifications
thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of
Human Subjects), 56 (Institutional Review Boards) and 312

 

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(Investigational New Drug Application), and (d) the equivalent applicable Laws
in any relevant country, in each case, that provide for, among other things,
assurance that the clinical data and reported results are credible and accurate
and protect the rights, integrity, and confidentiality of trial subjects.

1.64. “GDP” or “Global Development Plan” means the plan for the Parties’
worldwide Development (and related Manufacturing) of the Product in the Field,
including regulatory strategy, identification of specific Clinical Studies to be
conducted, naming the Oncology Indications to be pursued, and general design
parameters, including patient enrollment targets, combination agents and
comparators and including the Development Budget, for the relevant Calendar
Years in accordance with Section 4.1.1 in accordance with the terms of this
Agreement. The initial GDP is attached hereto as Exhibit C.

1.65. “Global Branding Strategy” means the global branding strategy for Products
in the Field throughout the world, including, with respect to each such Product,
a life cycle plan, brand vision, positioning, key messaging, concept and
imagery, Product Trademarks (including name and logos), brand public relations
and supporting market research.

1.66. “GLP” or “Good Laboratory Practice” means all applicable then-current
standards for laboratory activities for pharmaceuticals, as set forth in the
FDA’s Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58 or
the Good Laboratory Practice principles of the Organization for Economic
Co-Operation and Development (OECD), and such standards of good laboratory
practice as are required by the European Union and other organizations and
governmental agencies in countries in which a Product is intended to be sold, to
the extent such standards are not less stringent than United States Good
Laboratory Practice.

1.67. “GMP” or “Good Manufacturing Practice” means all applicable then-current
standards for Manufacturing, including, as applicable, (a) the principles
detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections
210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4,
(c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent
applicable Laws in any relevant country, each as may be amended and applicable
from time to time.

1.68. “Governmental Authority” means any multinational, federal, national,
state, provincial, local or other entity, office, commission, bureau, agency,
political subdivision, instrumentality, branch, department, authority, board,
court, arbitral or other tribunal, official or officer, exercising executive,
judicial, legislative, police, regulatory, administrative or taxing authority or
functions of any nature pertaining to government.

1.69. “Government Health Care Programs” means the Medicare program (Title XVIII
of the Social Security Act), the Medicaid program (Title XIX of the Social
Security Act), TRICARE, the Federal Employee Health Benefits Program, and other
foreign, federal, state and local governmental health care plans and programs.

1.70. “Government Order” means any order, writ, judgment, injunction, decree,
stipulation, ruling, determination or award entered by or with any Governmental
Authority.

 

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1.71. “Health Care Laws” means Laws relating to Government Health Care Programs,
Private Health Care Plans, privacy and confidentiality of patient health
information and human biological materials, including, in the United States,
federal and state Laws pertaining to the federal Medicare and Medicaid programs
(including the Medicaid rebate program); federal Laws pertaining to the Federal
Employees Health Benefit Program, the TRICARE program and other Government
Health Care Programs; federal and state Laws applicable to health care fraud and
abuse, kickbacks, physician self-referral and false claims (including 42 U.S.C.
§1320a-7a, 42 U.S.C. §1320a-7b, 42 U.S.C. §1395nn and the federal Civil False
Claims Act, 31 U.S.C. §3729 et. seq.); the Health Insurance Portability and
Accountability Act of 1996; the Patient Protection and Affordable Care Act
(“ACA”); and 45 C.F.R. Part 46; as well as similar Laws in jurisdictions outside
the United States.

1.72. “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976,
as amended (15 U.S.C. §18a), and the rules and regulations promulgated
thereunder.

1.73. “ICH” means the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use.

1.74. “Incremental Withholding Tax” means the net increase in Withholding Tax
for any taxable year caused by AbbVie Withholding Tax Actions that are not
Required Withholding Tax Actions occurring on and after the Execution Date,
provided the net aggregate increase exceeds [**] Dollars calculated on an annual
basis using the exchange rate on the date of the payment subject to Withholding
Tax. For clarity, Incremental Withholding Tax shall include the entire net
increase in Withholding Tax caused by AbbVie Withholding Tax Actions that are
not Required Withholding Tax Actions if the annual net aggregate increase of
[**] Dollars has been reached (i.e. not only amounts in excess of [**] Dollars).

1.75. “IND” means an application filed with a Regulatory Authority for
authorization to commence Clinical Studies, including (a) an Investigational New
Drug Application as defined in the FFDCA or any successor application or
procedure filed with the FDA, (b) any equivalent of a United States IND in other
countries or regulatory jurisdictions, (i.e., Clinical Trial Application (CTA))
and (c) all supplements, amendments, variations, extensions and renewals thereof
that may be filed with respect to the foregoing.

1.76. “Indemnified Party” means a Person entitled to indemnification under
ARTICLE 11.

1.77. “Indemnifying Party” means a Party from whom indemnification is sought
under ARTICLE 11.

1.78. “Infinity-Borne Development Costs” means all Development Costs that are
not Shared Development Costs.

1.79. “Infinity Intellectual Property” means Infinity Know-How and Infinity
Patent Rights.

 

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1.80. “Infinity Know-How” means all Know-How Controlled by Infinity or any of
its Affiliates, as of the Execution Date or during the Term, that is not
generally known and is necessary or useful for the Development, Manufacture or
Commercialization of any Licensed Compound or Product in the Field in the
Territory, including the rights of Infinity or its Affiliates in Infinity Sole
Inventions and Joint Inventions, but excluding any Know-How to the extent
Covered by published Infinity Patent Rights.

1.81. “Infinity Patent Rights” means all Patent Rights Controlled by Infinity or
any of its Affiliates, as of the Execution Date or during the Term, that are
necessary or useful for the Development, Manufacture or Commercialization of any
Licensed Compound or Product in the Field, including the rights of Infinity or
its Affiliates in Joint Patent Rights and in Patent Rights Covering Infinity
Sole Inventions. As of the Execution Date, the Infinity Patent Rights include
the Patent Rights set forth in Exhibit B.

1.82. “Infinity Third Party Agreements” means (a) the Existing Infinity Third
Party Agreements and (b) any Third Party agreement entered into by Infinity
pursuant to Section 3.5; each such agreement as it may be amended from time to
time in accordance with the terms of this Agreement.

1.83. “Infinity Third Party Agreement Payments” means (a) all payments under
Infinity Third Party Agreements entered pursuant to Section 3.5 that arise out
of the Development or Commercialization of any Licensed Compound or Product
under this Agreement, but excluding any payments due by Infinity to Intellikine
under any agreement that grants to Infinity rights to any intellectual property
granted to Infinity at any time under the Intellikine Agreement, and
(b) Existing Infinity Third Party Agreement Payments, except amounts paid
(either directly or as reimbursement) under Infinity Third Party Agreements in
preparing, filing, prosecuting or maintaining Patent Rights.

1.84. “Intellikine” means Intellikine LLC.

1.85. “Intellikine Agreement” means the Amended and Restated Development and
License Agreement, made as of December 24, 2012, by and between Intellikine and
Infinity, as amended by the Amendment to the Amended and Restated Development
and License Agreement dated as of July 29, 2014 and as may be further amended,
[**].

1.86. “Investigator Sponsored Clinical Study” means a human clinical study of a
pharmaceutical or diagnostic product that is sponsored and conducted by a Third
Party, other than pursuant to an IND held by a Party, under an agreement with a
Party or its Affiliate pursuant to which such Party or such Affiliate provides
clinical supplies of such product or funding for such clinical study.

1.87. “Joint Patent Rights” means Patent Rights Covering Joint Inventions.

1.88. “Know-How” means all technical information, know-how and data, including
inventions, discoveries, trade secrets, specifications, instructions, processes,
formulae, materials, expertise and other technology applicable to formulations,
compositions or products or to their manufacture, development, registration, use
or marketing or to methods of assaying or testing them or processes for their
manufacture, formulations containing them or compositions incorporating or
comprising them, and including all biological, chemical, pharmacological,
biochemical, toxicological, pharmaceutical, physical and analytical, safety,
quality control,

 

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manufacturing, Data, information contained in Regulatory Filings, instructions,
processes, formulae, expertise and information, relevant to the research,
development, manufacture, use, importation, offering for sale or sale of, or
which may be useful in studying, testing, developing, producing or formulating,
products, or intermediates for the synthesis thereof. Know-How excludes the
Patent Rights covering any inventions.

1.89. “Label Expansion” means, following first receipt of Regulatory Approval
for a pharmaceutical or diagnostic product in an Oncology Indication (the “First
Approval in an Oncology Indication” for such Product), any subsequent receipt of
Regulatory Approval for such Product in the same Oncology Indication as such
First Approval in an Oncology Indication, for a different subpatient population,
line of therapy or new use as a monotherapy or in combination with another
treatment or drug for such Oncology Indication.

1.90. “Law” means any applicable multinational, federal, national, state,
provincial, county or local or other law, statute, standard, ordinance, code,
rule, regulation, resolution or promulgation, or any Government Order, or any
license, franchise, permit or similar right granted under any of the foregoing,
or any similar provision having the force or effect of law, and shall include,
as applicable, GLP, GCP, GMP, Drug Regulation Laws, Clinical Investigation Laws
and Health Care Laws, the rules or regulations of the United States Securities
and Exchange Commission or similar regulatory agency in a country other than the
United States or of any stock exchange (including NASDAQ), all applicable United
States and foreign laws with respect to the transfer of pharmaceutical or
diagnostic products and related technical data to countries other than the
United States, including the International Traffic in Arms Regulations (ITAR)
and the Export Administration Regulations, the U.S. Foreign Corrupt Practices
Act (the “FCPA”), the UK Bribery Act 2010, and all applicable government
importation laws and regulations of a particular country for pharmaceutical or
diagnostic products made outside the particular country in which such
pharmaceutical or diagnostic products are used or sold.

1.91. “Licensed Compound” means the compound known as IPI-145, as further
described in Exhibit D, and any racemates, salts, metabolites, esters, isomers,
diastereomers, tautomers, enantiomers, prodrug forms, hydrates, solvates,
intermediates, polymorphs and degradants thereof, in each case, that have
substantially the same pharmacological effect, in crystal, powder or other form.
As used in this Agreement, except where not appropriate in context, the Licensed
Compound also means any Product containing the Licensed Compound.

1.92. “Losses” means damages, losses, liabilities, costs (including costs of
investigation, defense), fines, penalties, taxes, expenses, or amounts paid in
settlement (in each case, including reasonable attorneys’ and experts’ fees and
expenses), in each case resulting from an Action by a Third Party.

1.93. “MAA” means (a) a marketing authorization application filed with (i) the
EMA under the centralized EMA filing procedure or (ii) a Regulatory Authority in
any EU country if the centralized EMA filing procedure is not used, or (b) any
other equivalent or related regulatory submission; in either case to gain
approval to market a pharmaceutical or diagnostic product in any country in the
EU, and, in each case, including any amendments thereto, and supplemental
applications but excluding Pricing and Reimbursement Approval applications.

 

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1.94. “Major Market Country” means each of the United Kingdom, France, Germany,
Italy, Spain, and Japan.

1.95. “Manufacture” or “Manufacturing” means activities directed to producing,
manufacturing, scaling up, processing, filling, finishing, packaging, labeling,
quality assurance testing and release, shipping and storage of a pharmaceutical
or diagnostic product or component thereof (including production of drug
substance and drug product, in bulk form, for preclinical and Clinical Studies
and for Commercialization).

1.96. “Manufacturing Plan” means the plan for the Parties’ worldwide preclinical
and clinical or commercial, as the case may be, Manufacturing of the Product in
the Field.

1.97. “Marketing Authorization” means the grant of all necessary permits,
registrations, authorizations, licenses and approvals (or waivers) required for
the Manufacture, Commercialization, promotion, marketing, storage, import,
export, transport, distribution, use, offer for sale, sale or other
commercialization of a Product in any country, including, where required,
Pricing and Reimbursement Approvals.

1.98. “Medical Affairs Activities” means the following activities, to the extent
related to a Product in the Field in the Territory: responding to external
inquiries or complaints, the planning for and conduct of Investigator Sponsored
Clinical Studies not included in the GDP, medical education, HECOR, speaker
programs, advisory boards, thought leader activities, educational grants and
fellowships, local country government affairs, Phase IIIb Clinical Studies,
Phase IV/Post-Approval Clinical Studies, generating Commercialization Support
Data, deployment of MSLs, medical affairs clinical trial management, MDs in
field (other than MSLs), scientific publications and medical communications. For
clarity, Medical Affairs Activities shall not include Research, Development,
Manufacture or Commercialization activities.

1.99. “Medical Affairs FTE Costs” means the product of the number of Medical
Affairs FTEs times the FTE Rate, where a “Medical Affairs FTE” means a
scientific, medical, project management, operations, technical or other
individual engaged full time for one (1) Calendar Year (consisting of at least a
total of [**] hours per Calendar Year) in performing or supporting Medical
Affairs Activities. No additional payment shall be made with respect to any
individual who works more than [**] hours per Calendar Year and any individual
who devotes less than [**] hours per Calendar Year (or such other number as may
be agreed by the JMAC or JSC, as applicable) shall be treated as a Medical
Affairs FTE on a pro rata basis based upon the actual number of hours worked
divided by [**]; provided that such individual devotes a minimum of [**] hours
per Calendar Year to performing or supporting Medical Affairs Activities under
the Medical Affairs Plan.

1.100. “Medical Affairs Plan” means a plan for the Parties’ worldwide Medical
Affairs Activities, including the allocation of such activities to the Parties
and the associated Medical Affairs Budget included therein.

1.101. “MICL Agreement” means the Termination and Revised Relationship
Agreement, entered into as of July 17, 2012, by and between Mundipharma
International Corporation Limited and Infinity.

 

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1.102. “MSL” means medical science liaison.

1.103. “MSL Deployment Plan” means, with respect to a Product and a country or
region, a plan that defines the overall MSL FTEs in such country or region and
includes: target audience assessment and coverage requirements, and coordinated
coverage and targeting plan between MSL teams from each Party.

1.104. “MSL FTE” means, with respect to a Product in a country, the time and
effort of MSLs that, in the aggregate, is equivalent to the time and effort of
one (1) employee devoted exclusively to MSL activities based on [**] person
hours per year.

1.105. [**].

1.106. [**].

1.107. “NDA” or “New Drug Application” means an application submitted to the FDA
pursuant to 21 U.S.C. §505(b), which contains complete details of the
manufacture and testing of a new drug, for purposes of obtaining Regulatory
Approval for such new drug in the United States, for a particular Oncology
Indication, and, with respect to a Diagnostic Product, a premarket approval or
comparable application, in each case including amendments thereto and
supplemental applications.

1.108. “Net Sales” means, with respect to a Product for any period, the total
gross amount billed or invoiced on sales of such Product during such period by a
Party, its Affiliates, or Sublicensees (other than Sublicensees that are
wholesalers or distributors) in the Territory to Third Parties (including
wholesalers or distributors that are also Sublicensees), in bona fide arm’s
length transactions, less the following deductions (such deductions, the
“Deductions”), in each case related specifically to the Product and actually
allowed and taken by such Third Parties and not otherwise recovered by or
reimbursed to such Party, its Affiliates, or Sublicensees:

(a) trade, cash and quantity discounts;

(b) price reductions or rebates, retroactive or otherwise, imposed by,
negotiated with or otherwise paid to governmental authorities or other payees;

(c) taxes on sales (such as sales, value added, or use taxes) to the extent
added to the sale price and set forth separately as such in the total amount
invoiced;

(d) amounts repaid or credited by reason of rejections, defects, return goods
allowances, recalls or returns, or because of retroactive price reductions,
including rebates or wholesaler charge backs;

(e) the portion of administrative fees paid during the relevant time period to
group purchasing organizations, pharmaceutical benefit managers or Medicare
Prescription Drug Plans relating to such Product;

(f) any invoiced amounts from a prior period which have not been collected and
have been written off by a Party or its Affiliates, including bad debts, to the
extent such amounts have not been previously deducted; provided that any such
amounts that are written off shall be added back in a subsequent period to the
extent later collected;

 

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(g) freight, insurance, import/export, and other transportation charges to the
extent added to the sale price and set forth separately as such in the total
amount invoiced, as well as any fees for services provided by wholesalers and
warehousing chains related to the distribution of such Product; and

(h) any other similar and customary deductions that are consistent with the
selling Party’s Accounting Standards, but which are not be duplicative of the
deductions specified in (a) – (g) above.

Net Sales shall not include transfers or dispositions for charitable,
promotional, pre-clinical, clinical, regulatory, or governmental purposes, in
all cases, without consideration. Net Sales shall include the amount or fair
market value of all other consideration received by a Party, its Affiliates or
Sublicensees in respect of the Product, whether such consideration is in cash,
payment in kind, exchange or other form. Net Sales shall not include sales
between or among a Party, its Affiliates, or Sublicensees.

Subject to the above, Net Sales shall be calculated in accordance with the
standard internal policies and procedures of the selling Party, its Affiliates,
or Sublicensees, which must be in accordance with its Accounting Standards.

For purposes of calculating Net Sales, all Net Sales shall be converted into
Dollars in accordance with Section 7.7.

In the event a Product is a Combination Product, the Net Sales for such
Combination Product shall be calculated as follows:

(a) If a Party, its Affiliate, or Sublicensee separately sells in such country
or other jurisdiction, (i) a product containing as its sole active ingredient a
Licensed Compound contained in such Combination Product (the “Mono Product”) and
(ii) products containing as their sole active ingredients the other active
ingredients in such Combination Product, the Net Sales attributable to such
Combination Product shall be calculated by multiplying actual Net Sales of such
Combination Product by the fraction A/(A+B) where: “A” is the Party’s (or its
Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the
period to which the Net Sales calculation applies for the Mono Product in such
country or other jurisdiction and “B” is such Party’s (or its Affiliate’s or
Sublicensee’s, as applicable) average Net Sales price during the period to which
the Net Sales calculation applies in such country or other jurisdiction, for
products that contain as their sole active ingredients the other active
ingredients in such Combination Product.

(b) If a Party, its Affiliate, or Sublicensee separately sells in such country
or other jurisdiction the Mono Product but does not separately sell in such
country or other jurisdiction products containing as their sole active
ingredients the other active ingredients in such Combination Product, the Net
Sales attributable to such Combination Product shall be calculated by
multiplying the Net Sales of such Combination Product by the fraction A/C where:
“A” is a

 

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Party’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales
price during the period to which the Net Sales calculation applies for the Mono
Product in such country or other jurisdiction, and “C” is such Party’s (or its
Affiliate’s or Sublicensee’s, as applicable) average Net Sales price in such
country or other jurisdiction during the period to which the Net Sales
calculation applies for such Combination Product.

(c) If a Party, its Affiliates, and Sublicensees do not separately sell in such
country or other jurisdiction the Mono Product but do separately sell products
containing as their sole active ingredients the other active ingredients
contained in such Combination Product, the Net Sales attributable to such
Combination Product shall be calculated by multiplying the Net Sales of such
Combination Product by the fraction (D-E)/D where: “D” is the average Net Sales
price during the period to which the Net Sales calculation applies for such
Combination Product in such country or other jurisdiction and “E” is the average
Net Sales price during the period to which the Net Sales calculation applies for
products that contain as their sole active ingredients the other active
ingredients in such Combination Product.

(d) If a Party, its Affiliates, and Sublicensees do not separately sell in such
country or other jurisdiction both the Mono Product and the other active
ingredient or ingredients in such Combination Product, the Net Sales
attributable to such Combination Product shall be calculated by multiplying the
Net Sales of such Combination Product by the fraction 1/(1+F) where: “F” is the
number of other active ingredients (other than a Licensed Compound) in such
Combination Product;

provided, however, that if the Combination Product includes a Licensed Compound
and AbbVie Combination Compound as the only active ingredients, then the Net
Sales attributable to such Combination Product hereunder shall be equal to [**]
percent ([**]%) of the Net Sales of such Combination Product.

1.109. “Non-Oncology Indication” means any disease, condition, disorder or
syndrome, or sign or symptom of, or associated with, a disease, condition,
disorder or syndrome, excluding all Oncology Indications.

1.110. “Oncology Indication” means a cancerous condition resulting from a
separate and distinct hematological cancer, tumor type or other cancer that is
the basis for a separate and distinct Regulatory Approval. Non-limiting examples
of distinct Oncology Indications include: chronic lymphocytic leukemia, indolent
non-Hodgkin lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large
B-cell lymphoma, peripheral T-cell lymphomas, acute myeloid leukemia, acute
lymphoblastic leukemia, Hodgkin lymphoma, renal cell carcinoma, non-small cell
lung cancer, colon cancer, breast cancer, pancreatic cancer, etc. On a
Product-by-Product and country-by-country basis, once a Product has received
Regulatory Approval in an Oncology Indication (a) where such Regulatory Approval
is for the use of such Product alone or in combination with other treatment
modalities, the subsequent receipt of Regulatory Approval of such Product in
combination with other treatment modalities or alone, respectively, for such
Oncology Indication shall not be considered a different Oncology Indication but
shall be considered a Label Expansion with respect to such Oncology Indication
for such Product, (b) where such Regulatory Approval is for use of such Product
in one line of therapy, the subsequent receipt of Regulatory Approval of such
Product in another line of therapy for such Oncology

 

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Indication shall not be considered a different Oncology Indication but shall be
considered a Label Expansion with respect to such Oncology Indication for such
Product or (c) where such Regulatory Approval is for the use of such Product
within a defined subset of patients within an Oncology Indication, the
subsequent receipt of Regulatory Approval of such Product within a different
defined subset of patients within such Oncology Indication (e.g., elderly, or
genetically defined patients subgroups such as chronic lymphocytic leukemia
patients with a 17 p deletion) shall not be considered a different Oncology
Indication but shall be considered a Label Expansion with respect to such
Oncology Indication for such Product.

1.111. “Orange Book” means the publication Approved Drug Products with
Therapeutic Equivalence Evaluations that identifies drug products approved on
the basis of safety and effectiveness by the FDA under the FFDCA.

1.112. “Out-of-Pocket Costs” means (a) amounts paid to Third Party vendors or
contractors for services or materials provided by them directly in the
performance of activities under the GDP, the Medical Affairs Plan or the
relevant Commercialization Plan, as applicable, to the extent such services or
materials apply solely and directly to a Licensed Compound or Product (or such
amounts paid to Third Parties for other activities not included in determination
of Development Costs or Allowable Expenses, but for which sharing of
Out-of-Pocket Costs is otherwise specified in this Agreement), or (b) solely
with respect to Section 7.5.3, the amounts paid to an independent, certified
public accountant to conduct an audit in accordance with Section 7.5.1. For
clarity, Out-of-Pocket Costs do not include payments for internal expenses or
the out-of-pocket portion, if any, of the following expenses: salaries or
benefits; facilities; utilities; general office or facility supplies; insurance
(other than clinical trial insurance); information technology, capital
expenditures or the like.

1.113. “Party” means either Infinity or AbbVie; “Parties” means Infinity and
AbbVie, collectively.

1.114. “Patent Costs” means all reasonable Out-of-Pocket Costs incurred by a
Party or its Affiliate in preparing, filing, prosecuting or maintaining the
relevant Patent Rights, which, for purposes of this Section, shall not include
the [**] (including the reasonable fees and expenses paid to outside counsel and
other Third Parties, and filing and maintenance fees paid to governmental
authorities) recorded as an expense by a Party or any of its Affiliates in
accordance with Accounting Standards after the Effective Date, during the Term
of and pursuant to this Agreement, including costs of patent interference,
opposition, reissue, or re-examination proceedings, or any other pre- or
post-grant proceedings in the USPTO, EPO or foreign equivalent, and filing and
registration fees with respect to the relevant Patent Rights.

1.115. “Patent Rights” means all patents and patent applications (including
provisional applications), including all divisionals, continuations,
substitutions, continuations-in-part, re-examinations, re-issues, additions,
renewals, extensions, confirmations, registrations, any other pre- or post-grant
forms of any of the foregoing, any confirmation patent or registration patent or
patent of addition, utility models, patent term extensions, and supplemental
protection certificates or requests for continued examinations, foreign
counterparts, and the like of any of the foregoing.

 

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1.116. “Person” means any natural person, corporation, general partnership,
limited partnership, joint venture, proprietorship or other business
organization or a Governmental Authority.

1.117. “Phase I Clinical Study” means a clinical study in humans which provides
for the first introduction into humans of a pharmaceutical product, conducted in
normal subjects or patients to generate information on product safety,
tolerability, pharmacological activity or pharmacokinetics, as more fully
defined in Federal Regulation 21 C.F.R. §312.21(a) and its foreign equivalents.

1.118. “Phase II Clinical Study” means a clinical study in humans of the safety,
dose ranging and efficacy of a pharmaceutical product, as described in Federal
Regulation 21 C.F.R.§312.21(b) and its foreign equivalents.

1.119. “Phase III Clinical Study” means a controlled clinical study, or a
portion of a controlled study, in humans of the efficacy and safety of a
pharmaceutical product, which study (in its entirety or portion, as applicable),
is prospectively designed to demonstrate statistically whether such product is
effective and safe for use in a particular Oncology Indication in a manner
sufficient to file an NDA, MAA or other Regulatory Approval Application to
obtain Regulatory Approval, as further defined in Federal Regulation 21 C.F.R.
§312.21(c) and its foreign equivalents. For the sake of clarity, with respect to
what is commonly called a phase 2/3 study, the Phase III Study definition is met
upon the first patient, first visit in the portion of such study that is
prospectively designed to demonstrate statistically whether such pharmaceutical
product is effective and safe for use in a particular Oncology Indication in a
manner sufficient to file an NDA, MAA or other Regulatory Approval Application
to obtain Regulatory Approval, as further defined in Federal Regulation 21
C.F.R. §312.21(c) and its foreign equivalents.

1.120. “Phase IIIb Clinical Study” means a clinical study conducted after the
submission of a Regulatory Approval Application, but prior to receipt of
Marketing Authorization. Such studies may supplement prior studies, complete
prior studies, or be directed towards new types of studies or Phase IV
evaluations.

1.121. “Phase IV/Post-Approval Clinical Study” means a clinical study in humans
initiated in a country after receipt of Regulatory Approval for a pharmaceutical
or diagnostic product in such country, usually within or in support of the
approved product labeling.

1.122. “Pricing and Reimbursement Approval” means, with respect to a
pharmaceutical or diagnostic product, the governmental approval, agreement,
determination or decision establishing the price or level of reimbursement for
such product, in a given jurisdiction prior to sale of such product in such
jurisdiction.

1.123. “Private Health Care Plans” means non-governmental Third Party health
care payors and plans, including insurance companies, health maintenance
organizations and other managed care organizations, Blue Cross and Blue Shield
plans and self-funded employers.

1.124. “Prior CDA” means the Confidential Disclosure Agreement between Infinity
and AbbVie, dated [**] (the “Prior CDA Effective Date”).

 

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1.125. “Product” means any product comprising or containing any Licensed
Compound, alone or in combination with other active pharmaceutical ingredients,
in any and all forms, in current and future formulations, dosage forms and
strengths, and delivery modes; provided, however, that Product shall not include
any compound (other than a Licensed Compound) that is Covered by or embodies any
Patent Rights or Know-How and that is, in either case, Controlled by a Party or
any of its Affiliates, without such Party’s prior written consent. As used in
this Agreement, except where not appropriate in context, the Product also
(a) means the Licensed Compound contained in such Product, and (b) includes any
Diagnostic Product related to such Product, to the extent Controlled by the
relevant Party.

1.126. “Product Liability Action” means any Action brought by a Third Party to
the extent in respect of any personal bodily injury or death (or risk of
personal bodily injury or death) resulting from the use or ingestion of, or
exposure to, a Product following the Effective Date, whether based on
negligence, strict product liability or any other product liability theory,
including liability predicated on any alleged or actual manufacturing, design or
formulation defect, any failure to warn, any breach of any express or implied
warranties or any breach of this Agreement or a Related Agreement.

1.127. “Product Liability Costs” means those Out-of-Pocket Costs, Development
FTE Costs and Commercial FTE Costs incurred in connection with the defense of
any Product Liability Actions.

1.128. “Product Trademark” means, with respect to a Product, any trademark or
service mark as may be proposed by Infinity pursuant to Section 8.7.2(a), for
use in connection with the Commercialization of such Product in the Field
anywhere in the world, or accompanying logos, trade dress or indicia of origin.

1.129. “Promotional Materials” means, with respect to a Product, sales,
promotion, market access and advertising materials, including Product packaging,
help-seeking and disease-awareness advertisements, pertaining to such Product.

1.130. “Purdue Agreement” means the Termination and Revised Relationship
Agreement, entered into as of July 17, 2012, by and between Purdue
Pharmaceuticals Products L.P. and Infinity.

1.131. “Recall” means a Party’s removal or correction of a Product that the FDA
(or analogous foreign entity) considers to be in violation of the laws it
administers and against which the agency (or analogous foreign entity) would
initiate legal action, e.g., seizure. For clarity, a Recall does not include a
market withdrawal or a stock recovery.

1.132. “Regulatory Approval Application” means (a) an NDA, or (b) an MAA or
other application to seek Regulatory Approval of a Product in any country(ies)
outside the United States, as defined in the applicable Laws and filed with the
Regulatory Authority of such country(ies).

1.133. “Regulatory Approval” means the approval of the applicable Regulatory
Authority necessary for the marketing and sale of a Product in the Field in a
country(ies), excluding separate Pricing and Reimbursement Approval that may be
required, and including Label Expansions.

 

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1.134. “Regulatory Authority” means any multinational, federal, national, state,
provincial or local regulatory agency, department, bureau or other governmental
entity with authority over the clinical development, manufacture, marketing and
sale of a pharmaceutical or diagnostic product in a country, including FDA in
the United States and EMA in the EU.

1.135. “Regulatory Filing” means any documentation comprising or relating to or
supporting any filing or application with any Regulatory Authority with respect
to a Licensed Compound or corresponding Product, or its use or potential use in
the Field, including any documents submitted to any Regulatory Authority,
including INDs, Regulatory Approval Applications, and all correspondence with
any Regulatory Authority with respect to any Licensed Compound or Product
(including minutes of any meetings, telephone conferences or discussions with
any Regulatory Authority).

1.136. “Related Agreement” means each of the following: each Supply Agreement,
the Quality Agreement and any other agreement between a Party or any of its
Affiliates, on the one hand, or the other Party or any of its Affiliates, on the
other hand, entered into pursuant to this Agreement or any other Related
Agreement.

1.137. “Required Incremental Withholding Tax” means the net increase in
Withholding Tax for any taxable year caused by an AbbVie Withholding Tax Action
that is a Required Withholding Tax Action occurring on and after the Execution
Date.

1.138. “Required Withholding Tax Action” means an AbbVie Withholding Tax Action
that AbbVie takes to Commercialize a Product that (i) is required by Law (i.e.,
there is no other permitted way for AbbVie to Commercialize such Product other
than to assign, license or otherwise transfer the rights to the Product to a
foreign Affiliate of AbbVie, its successor or Sublicensee), or (ii) represents
the only commercially reasonable alternative to Commercialize such Product, as
determined by the JSC, the approval of which from each Party’s representatives
shall not be unreasonably withheld.

1.139. “Required Withholding Tax Benefit” means any tax deducted by Infinity (or
any Infinity Affiliates or successors) or claimed by Infinity (or any Infinity
Affiliates or successors) as a credit under Code section 901, 902 or 960, for a
taxable year that is attributable to any Required Incremental Withholding Tax,
less any prior year credits for Required Incremental Withholding Tax that are
disallowed as a result of the carryback of net operating losses.

1.140. “Research” means, with respect to a compound, activities prior to the
initiation of the first IND-enabling GLP toxicology study for such compound,
including but not limited to conducting medicinal chemistry. Research shall not
include Development, Commercialization, Manufacturing or Medical Affairs
Activities.

1.141. “Residual Knowledge” means knowledge, techniques, experience and Know-How
in intangible form (i.e., not written or other documentary form) that the
receiving Party can demonstrate are incidentally and unintentionally retained in
memory by employees of the receiving Party who have had access to the
Confidential Information of the disclosing Party and where the source of the
Confidential Information has become remote (e.g., as a result of the passage of
time or the employee’s subsequent exposure to information of a similar nature
from

 

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other sources) such that the employee is not able to identify the disclosing
Party as the source of the Confidential Information without refreshing his or
her recollection. In no event, however, will Residual Knowledge include any
knowledge, techniques, experience and Know-How to the extent (at any time, for
such time) within the scope of any Valid Claim or copyright owned or Controlled
by the disclosing Party.

1.142. “Sales Call” means, with respect to a Product in the US, a one-on-one,
face-to-face contact (or any other type of contact, including telephone contact,
that the Parties mutually agree, through the JCC, constitutes sufficient contact
for purposes of this definition) of a Sales Representative with a medical
professional with prescribing authority during which scientific or medical
information about the use of such Product for any indication in the Field for
which such Product has received Regulatory Approval in the US is discussed, and,
for three (3) years following such Regulatory Approval, during which no more
than two (2) products (including the Product) are so presented.

1.143. “Sales Force Deployment Plan” means, with respect to a Product in the US,
a plan that defines the overall Sales Representative FTEs in the US and
includes: target audience assessment and coverage requirements, and coordinated
coverage and targeting plan between sales teams from each Party.

1.144. “Sales Manager FTE” means with respect to a Product in the US, the total
number of sales managers supporting the Sales Representatives making Sales Calls
with respect to such Product in such country.

1.145. “Sales Representative FTE” means, with respect to a Product in the US,
the total number of Sales Representatives making Sales Calls with respect to
such Product in the US, calculated based on the percentage of such individual’s
incentive bonus target applicable to such Product in such country. By way of
example, if fifty percent (50%) of such individual’s incentive bonus target is
available for such Product in the US, then such individual shall be fifty
percent (50%) of a Sales Representative FTE. The same incentive calculation
methodology shall be used to determine the Sales Manager FTEs supporting the
Product.

1.146. “Sublicensee” means, with respect to a Party, a Third Party sublicensee
of rights granted to such Party under this Agreement or a Third Party licensee
of rights with respect to a Licensed Compound or Product which rights are
retained by such Party under this Agreement with respect to such Licensed
Compound or Product. For clarity, the rights and licenses granted to Intellikine
by Infinity upon termination of the Intellikine Agreement shall not be deemed
such a sublicense or license granted by Infinity hereunder and, with respect to
the rights and licenses granted to Intellikine upon termination of the
Intellikine Agreement, Intellikine and its Affiliates, licensees and
sublicensees shall not be considered a Sublicensee of Infinity.

1.147. “Territory” means worldwide.

1.148. “Third Party” means any Person other than a Party or any of its
Affiliates.

1.149. “[**].

 

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1.150. “United States,” “U.S.” “US” or “US Territory” means the United States of
America and its territories and possessions.

1.151. “US Commercialization Budget” means the budget for conducting
Commercialization activities for the Products in the US Territory pursuant to
the US Commercialization Plan for the relevant Calendar Years in accordance with
Section 5.3.1.

1.152. “US Commercialization Plan” means the commercialization plan with respect
to the Commercialization of the Products in the US Territory for the relevant
Calendar Years in accordance with Section 5.3.1, including an overall strategy
for Commercialization, a tactical plan to accomplish such strategy, a plan
regarding promotional educational/materials, sales force training, market
research and advisory board strategy, a public relations plan, HECOR strategy,
an advertising/public relations plan, managed care/contracting strategy, sales
force alignment, the US Commercialization Budget, the Sales Force Deployment
Plan, pricing strategy and determination of pricing, and annual forecasts
including demand units, supply units, Gross Sales and Net Sales (which forecasts
the Parties acknowledge and agree are non-binding and are not intended to
provide any assurance of future commercial success), in each case for the
Products in the US Territory, on a Product-by-Product basis, as developed,
approved and amended in accordance with this Agreement and consistent with the
Global Branding Strategy.

1.153. “Valid Claim” means a claim (including a process, use, or composition of
matter claim) of an issued and unexpired patent that has not (a) irretrievably
lapsed or been abandoned, revoked, dedicated to the public or disclaimed or
(b) been held invalid, unenforceable or not patentable by a court, governmental
agency, national or regional patent office or other appropriate body that has
competent jurisdiction, which holding, finding or decision is final and
unappealable or unappealed within the time allowed for appeal.

1.154. “Withholding Tax” means any tax required to be withheld and deducted from
a payment made (or to be made) pursuant to this Agreement.

1.155. “Withholding Tax Benefit” means any tax deducted by Infinity (or any
Infinity Affiliates or successors) or claimed by Infinity (or any Infinity
Affiliates or successors) as a credit under Code section 901, 902 or 960, for a
taxable year that is attributable to any Incremental Withholding Tax, less any
prior year credits for Incremental Withholding Tax that are disallowed as a
result of the carryback of net operating losses.

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

 

Definition

  

Section

1974 Convention    14.4 AbbVie    Preamble [**]    8.1.3 AbbVie Indemnified
Parties    11.1 AbbVie Sole Inventions    8.1.1 Acquisition Transaction   
3.7.3(a) ADR    13.1 Adverse Ruling    12.2.1(a)

 

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Definition

  

Section

Agreement Wind-Down Period    12.3.13 Alliance Manager    2.10 Alliance Manager
Expenses    Financial Exhibit Allowable Expenses    Financial Exhibit [**]   
4.1.6(c) [**]    4.1.6(c) Bankruptcy Code    3.7.4 Breaching Party    12.2.1
Collaboration Losses    Financial Exhibit Combination Study Costs    4.6.1
Commercial FTE    Financial Exhibit Commercial FTE Costs    Financial Exhibit
Competing Product    3.7.3(b) Conducting Party    4.2.3 Deductions    1.108
Development Reconciliation Procedures    4.6.2 Dispute    13.1 Distribution
Costs    Financial Exhibit Divest    3.7.3(c) DMF    4.4.4 EAP Expenses   
Financial Exhibit Enrollment Event    Schedule 7 EPO    8.2.1 Exchange Act   
1.16 Excluded Matters    2.9.3 Execution Date    Preamble Existing Patents   
10.2.1 FCPA    1.90 FFDCA    1.40 Finance Working Group    2.5 First Approval in
an Oncology Indication    1.89 First Year    4.1.5(b) Global Publication
Strategy    9.4.1 Headlicense Breach    10.6.5(b) Health Care Reform Fees   
Financial Exhibit Incomplete Activity    4.1.5(b) Indirect Taxes    7.6.5
Infinity    Preamble Infinity Indemnified Parties    11.2 Infinity Sole
Inventions    8.1.1 Infringement Claim    8.3.9(a) Intellikine Mark    8.7.3
IST/IIS Working Group    2.5 IP Working Group    2.5 JAMS    13.1.2 JCC    2.3.1
JDC    2.2.1

 

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Definition

  

Section

JMAC    2.4.1 Joint Inventions    8.1.2 Joint Product Patent Rights    8.2.1(a)
JSC    2.1.2 Launched Products    12.3.13 Manufacturing Working Group    2.5
Marketing Expenses    Financial Exhibit Marketing Related Materials    12.3.14
Medical Affairs Budget    4.2.2 Medical Affairs Costs    4.2.7 Medical Affairs
Plan    4.2.2 Medical Affairs Reconciliation Procedures    4.2.8 Milestone Event
   Schedule 7 Milestone Payment    Schedule 7 Mono Product    1.108 Net Profit
or Loss    Financial Exhibit Neutral    13.1.3 Non-Breaching Party    12.2.1
Non-Incurred Amount    4.1.5(b) Non-Sponsor    4.3.2(b) On-Going Clinical Study
   12.3.12 Other Commercialization Costs    Financial Exhibit Other Income   
Financial Exhibit Owed Party    7.5.3 Owing Party    7.5.3 Paragraph IV
Certification    8.3.2 Patent Challenge    12.2.3 Pharmacovigilance Working
Group    2.5 Post-Termination Royalty Term    12.3.7(b) Prior CDA Effective Date
   1.124 Product Trademark Costs    8.7.2(c)(iii) Profit Reconciliation
Procedures    7.2.1 Proposed Publications    9.4.2(b) Proposed Terms    13.13.2
Publishing Party    9.4.2(b) Quality Agreement    6.1.3 Recall Expenses   
Financial Exhibit Reconciliation Procedures    7.2.1 Regulatory Working Group   
2.5 Regulatory Maintenance Costs    Financial Exhibit Regulatory Owner   
4.4.3(a) Reimbursable Amounts    7.4.1 Reimbursing Party    4.2.3 Reviewing
Party    9.4.2(b) Right of Reference    4.4.4 Royalty Term    7.3.2

 

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Definition

  

Section

Sales Representative    5.7.1 Segregate    3.7.3(d) Selling Expenses   
Financial Exhibit Severed Clause    14.6 Shared Development Costs    4.6.1 [**]
   7.4.2 [**]    8.3.9(b) Shared Overage Costs    4.6.1 [**]    8.3.7 [**]   
8.2.4 Shared Product Liability Costs    11.4.3 [**]    7.4.2 Sole Inventions   
8.1.1 Sponsor    4.3.2(b) Sublicense    3.6.3 Succeeding Year(s)    4.1.5(b)
Supply Agreements    6.1.1 Supply Price    Financial Exhibit Support Memorandum
   13.13.2 Term    12.1 Termination and Wind-Down Plan    12.3.1 Third Party
Claim    11.3.1 Translational Medicine Working Group    2.5 USPTO    8.2.1(a)
Withholding Party    7.6.2 Working Group    2.5

ARTICLE 2.

MANAGEMENT OF COLLABORATIVE ACTIVITIES

2.1. Overview of Collaboration.

2.1.1. Current Status. Prior to the Effective Date, Infinity has initiated
Clinical Studies of a Product containing the Licensed Compound. The Parties have
agreed to Develop and Commercialize Products in the Field in accordance with the
GDP and the Commercialization Plan, as applicable.

2.1.2. Joint Steering Committee. Formation; Purposes and Principles. Within [**]
days after the Effective Date, Infinity and AbbVie shall designate their
representatives to a joint steering committee (the “JSC”), comprised of senior
executives, to provide high-level oversight and decision-making regarding the
activities of the Parties under this Agreement. The Parties anticipate that the
JSC will not be involved in day-to-day implementation of activities under this
Agreement. The purposes of the JSC shall be (a) to review and approve the
overall global Development, Medical Affairs, Manufacture and Commercialization
strategies, plans and budgets by reviewing and approving the GDP, the Medical
Affairs Plan and the Commercialization Plans, and to review and oversee the
overall global Development, Medical Affairs, Manufacture and

 

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Commercialization activities with respect to the Licensed Compounds and Products
pursuant to this Agreement, (b) to oversee the JDC, JCC, JMAC and the Working
Groups which report to the JSC, (c) to undertake the specific responsibilities
set forth in Section 2.1.3, and (d) in accordance with Section 2.9, to resolve
matters on which the JDC, JCC or JMAC are unable to reach consensus.

2.1.3. Specific Responsibilities. In addition to its overall responsibility for
the activities under this Agreement, the JSC shall in particular:

(a) review and approve annual updates and amendments to the GDP, including the
global regulatory strategy (and amendments and updates thereto) included in the
GDP and presented by the JDC;

(b) review and discuss, as necessary, the performance of each Party, or a
Party’s Affiliate or Sublicensee, as applicable, in performing the activities
under the GDP, the Medical Affairs Plan or the Commercialization Plans,
including actual financial results versus budget or plan, compliance with
applicable Laws and any agreed-upon standards for conduct of such activities and
progress of the Clinical Studies then on-going;

(c) review and approve the initial US Commercialization Plan, including the
initial US Commercialization Budget, and any amendments and updates to such US
Commercialization Plan and US Commercialization Budget, in each case presented
to the JSC by the JCC;

(d) review and approve the initial Ex-US Commercialization Plan and any
amendments and updates thereto, in each case presented to the JSC by the JCC;

(e) review and approve the initial Medical Affairs Plan, including the initial
Medical Affairs Budget, and any amendments and updates thereto, in each case
presented to the JSC by the JMAC;

(f) review and approve the Global Branding Strategy, and any amendments and
updates thereto, presented by the JCC;

(g) oversee the Finance Working Group and any other Working Groups that reports
into the JSC;

(h) attempt to resolve disputes within the JDC, the JCC, the JMAC, the Finance
Working Group or any other Working Group that reports to the JSC; and

(i) perform such other functions as are assigned to it in this Agreement or as
appropriate to further the purposes of this Agreement to the extent agreed to in
writing by the Parties.

2.2. Joint Development Committee.

2.2.1. Formation; Purposes. Within [**] days after the Effective Date, Infinity
and AbbVie shall designate their representatives to a joint development
committee (the “JDC”), which shall report to the JSC and have responsibility for
monitoring and facilitating the overall progress of Development activities under
this Agreement with respect to Products in the Field, including oversight of the
various budgets and activities.

 

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2.2.2. Specific Responsibilities. In particular, the JDC shall:

(a) oversee and coordinate the on-going transfer, in accordance with the terms
of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie
to Infinity of AbbVie Know-How, related to the Development of Licensed Compounds
and Products so that each Party may undertake Development of Licensed Compounds
and Products in accordance with the GDP and this Agreement;

(b) coordinate the activities of the Parties under the GDP and oversee the
implementation of the GDP;

(c) to the extent necessary, share planning and budgeting information with the
JCC and the JMAC and coordinate with the JCC and JMAC in preparing comprehensive
planning and budgeting proposals with respect to the Development,
Commercialization, Manufacturing and Medical Affairs Activities of Products in
the Field, as applicable;

(d) develop and update, on an annual basis, the proposed global regulatory
strategy for the Products in the Field in the Territory, and include such
proposed strategy in the GDP, for approval by the JSC in accordance with this
Agreement;

(e) on an annual basis, update the GDP, including the Development Budget and the
allocation of Development responsibilities between the Parties and present to
the JSC for approval proposed amendments to the GDP, including the Development
Budget, in accordance with Section 4.1.5;

(f) develop and update, on an annual basis, for inclusion in the GDP, the CMC
Development plans and the Manufacturing Plans for the pre-clinical and clinical
supply of the Licensed Compound and Products in the Territory;

(g) review and comment on Regulatory Filings relating to the Products in the
Field in accordance with Section 4.4;

(h) review and comment on the initial Global Publication Strategy and amendments
thereto prepared and presented by the JMAC from time to time in accordance with
Section 9.4.1;

(i) oversee the Regulatory Working Group, the Pharmacovigilance Working Group,
the Manufacturing Working Group, the IP Working Group, the Translational
Medicine Working Group and any other Working Groups that reports to the JDC;

(j) monitor progress and performance of Development activities under this
Agreement, including a review of actual financial results versus budget or plan;
and

(k) perform such other functions as are assigned to it in this Agreement or as
are appropriate to further the purposes of this Agreement as agreed in writing
by the Parties.

 

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2.3. Joint Commercialization Committee.

2.3.1. Formation; Purposes. Within [**] days after the Effective Date, Infinity
and AbbVie shall designate their representatives to a joint commercialization
committee (the “JCC”), which shall report to the JSC and have responsibility for
overseeing the implementation of all Commercialization activities under this
Agreement with respect to Products in the Field, including oversight of the
various budgets and activities.

2.3.2. Specific Responsibilities. In particular, the JCC shall:

(a) oversee and coordinate the on-going transfer, in accordance with the terms
of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie
to Infinity of AbbVie Know-How, related to the Commercialization of Licensed
Compounds and Products so that each Party may undertake Commercialization of
Licensed Compounds and Products in accordance with the Commercialization Plans
and this Agreement;

(b) oversee the Manufacturing Working Group to ensure that Manufacturing Plans,
and related budget information, are incorporated into the applicable
Commercialization Plans;

(c) develop and update, on an annual basis, Manufacturing Plans for inclusion in
the Commercialization Plans to ensure a reliable commercial supply of the
Licensed Compound and Products in the Territory;

(d) coordinate with the JDC with respect to regulatory matters;

(e) coordinate with the JDC with respect to pharmacovigilance matters;

(f) develop and present to the JSC for approval the Global Branding Strategy and
updates to such Global Branding Strategy during the Term as necessary;

(g) review and present to the JSC for approval the initial US Commercialization
Plan, including the US Commercialization Budget therein and the allocation of
Commercialization activities between the Parties, which US Commercialization
Plan shall be consistent with the Global Branding Strategy and Section 5.3.1, in
accordance with this Agreement and, as appropriate, present to the JSC for
review and approval proposed updates and amendments to such US Commercialization
Plan, including the US Commercialization Budget included therein;

(h) review and comment on the initial or updated (as applicable) Ex-US
Commercialization Plan, and any material amendments to such Ex-US
Commercialization Plans, and submit such plans to the JSC for review and
approval;

(i) coordinate the activities of the Parties under the US Commercialization Plan
and oversee the implementation of the US Commercialization Plan and oversee the
implementation of the Ex-US Commercialization Plan;

 

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(j) review each Party’s Commercialization activities in the US and AbbVie’s
Commercialization activities in the Ex-US Territory, including a review of
actual financial results versus budget or plan;

(k) to the extent necessary, share planning and budgeting information with the
JDC and JMAC and coordinate with the JDC and JMAC in preparing comprehensive
planning and budgeting proposals with respect to the Development, Manufacture
and Commercialization of Products and Medical Affairs Activities in the Field in
the US, as applicable;

(l) review and comment upon amendments and updates to the Global Publication
Strategy developed and presented by the JMAC in accordance with Section 9.4.1;

(m) oversee the Manufacturing Working Group, Co-Promotion Working Group and any
other Working Group that reports to the JCC;

(n) review and approve terms for Co-Promotion of Product in the United States
for inclusion in the US Commercialization Plan;

(o) review and update, on an annual basis, pricing, discounting and
reimbursement decisions for inclusion in the US Commercialization Plan; and

(p) perform such other functions as are assigned to it in this Agreement or as
are appropriate to further the purposes of this Agreement to the extent agreed
in writing by the Parties.

2.4. Medical Affairs Committee.

2.4.1. Formation; Purposes. Within [**] days after the Effective Date, Infinity
and AbbVie shall designate their representatives to a joint medical affairs
committee (the “JMAC”), which shall report to the JSC and have responsibility
for overseeing the implementation of all Medical Affairs Activities under this
Agreement with respect to Products in the Field and in the Territory.

2.4.2. Specific Responsibilities. In particular, the JMAC shall:

(a) oversee and coordinate the on-going transfer, in accordance with the terms
of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie
to Infinity of AbbVie Know-How, related to the Medical Affairs Activities with
respect to the Licensed Compounds and Products so that each Party may undertake
Medical Affairs Activities of Licensed Compounds and Products in accordance with
the Medical Affairs Plan and this Agreement;

(b) prepare and present to the JSC for approval the initial Medical Affairs Plan
(with input from the JDC and JCC), including the Medical Affairs Budget therein,
and the allocation of responsibilities between the Parties and, as appropriate,
prepare and present to the JSC for review and approval proposed interim and
annual updates and amendments to such Medical Affairs Plan, including the
Medical Affairs Budget;

 

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(c) review, approve and manage all Investigator Sponsored Clinical Studies and
ensure adherence to the Parties’ corporate policies and all federal/state
regulations;

(d) coordinate the activities of the Parties under the Medical Affairs Plan and
oversee the implementation of the Medical Affairs Plan;

(e) prepare and approve the Global Publication Strategy (with input from the JDC
and JCC) and any amendments thereto;

(f) prepare a MSL Deployment Plan for each of the United States, each Major
Market Country and certain other territories or regions in the Territory in
accordance with the Medical Affairs Plan;

(g) coordinate Congresses, scientific symposia, and scientific advisory boards;

(h) develop scientific and medical education communication platforms;

(i) provide a forum for and facilitate communications between the Parties with
respect to the Medical Affairs Activities for the Licensed Compound and
Products;

(j) meet promptly following its formation to discuss Infinity’s ongoing Medical
Affairs Activities with respect to the Product and the continuation of such
activities until such time as the JMAC establishes the initial Medical Affairs
Plan;

(k) oversee the IST/IIS Working Group and any other Working Group that reports
to the JMAC;

(l) review each Party’s Medical Affairs Activities under the Medical Affairs
Plan including review of actual financial results versus budget or plan; and

(m) perform such other functions as may be appropriate to further the purposes
of this Agreement with respect to the Medical Affairs activities for the
Licensed Compound and Products.

2.5. Working Groups. From time to time, the Parties or any Committee may
establish a working group (each, a “Working Group”) to oversee particular
projects or activities. Within thirty (30) days after the Effective Date,
Infinity and AbbVie shall designate their representatives to a finance working
group (the “Finance Working Group”), which shall initially report to the JSC; a
medical affairs working group (the “IST/IIS Working Group”), which shall
initially report to the JMAC; a regulatory working group (the “Regulatory
Working Group”), a pharmacovigilance working group (the “Pharmacovigilance
Working Group”), an intellectual property working group (the “IP Working
Group”), and a translational medicine working group (the “Translational Medicine
Working Group”), each of which shall initially report to the JDC; a co-promotion
working group (the “Co-Promotion Working Group”), which shall report to the JCC;
and a manufacturing working group (the “Manufacturing Working Group”), which
shall report to the JDC for Development-related Manufacturing matters and shall
report to the JCC for all matters involving Commercialization-related
Manufacturing matters. The Committee to which any

 

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Working Group reports may be reassigned upon approval of the JSC. Each Working
Group shall undertake the activities allocated to it herein or delegated to it
by the Committee to which it reports. During the process of establishing each
Working Group, such Working Group and the Committee to which it reports shall
agree regarding which matters such Working Group will resolve on its own and
which matters such Working Group will advise the Committee regarding (and with
respect to which such advice-specific matters the Committee will resolve);
provided, that no Committee or any other Person designated with authority
hereunder may delegate to a Working Group any decision-making authority over any
matter that has been expressly allocated to a Committee or such Person in
Section 2.9, and provided further, that the Parties acknowledge and agree that
each Working Group is intended to function primarily in a supporting role
providing advice to the Committee to which it reports, but that each Working
Group will be best positioned to provide expedited guidance regarding certain
operational matters as determined by and subject to the jurisdiction of the
Committee to which such Working Group reports. Any dispute arising within a
Working Group shall be referred to the Committee to which it reports for
resolution.

2.6. Membership. Each Committee and Working Group shall be composed of an equal
number of representatives appointed by each of Infinity and AbbVie. Each
Committee and Working Group shall be initially comprised of no more than [**]
representatives of each Party, or such other number as agreed upon by such
Committee. Each individual appointed by a Party as a representative to a
Committee or Working Group shall be an employee of such Party, or, other than a
representative appointed to the JSC, a contractor to such Party or an employee
or contractor of such Party’s Affiliate. Each Party shall appoint at least one
representative to each Working Group and shall have the right, but not the
obligation, to appoint the same number of representatives to any Working Group
as are appointed by the other Party to such Working Group. Each Party may
replace any of its Committee or Working Group representatives at any time upon
written notice to the other Party which notice may be given by e-mail, sent to
the other Party’s co-chairperson of such Committee or Working Group and, with
respect to a change of representatives to any Working Group, to the other
Party’s co-chairperson of the Committee to which such Working Group reports and,
with respect to a change of representatives to the Finance Working Group, to the
other Party’s co-chairpersons of the JDC, JCC and JMAC. Each Committee and
Working Group shall be co-chaired by one designated representative of each
Party. The co-chairperson of each Committee and Working Group shall cast its
Party’s vote (or the relevant co-chairperson or Party may designate another
representative to cast such vote or, if only one representative of a Party is
participating in the relevant meeting of the relevant Committee or Working
Group, such representative shall be deemed so designated to cast such Party’s
vote) on the respective Committee and Working Group and the co-chairperson or
such designee shall have the authority to make decisions on behalf of such
Party. The co-chairpersons shall be responsible for (a) calling meetings,
(b) preparing and circulating an agenda in advance of each meeting; provided,
that the co-chairpersons shall include any agenda items proposed by either Party
on such agenda, and (c) preparing and issuing minutes of each meeting within
[**] days (or such shorter time as is agreed by the relevant Committee or
Working Group) thereafter. For clarity, each Party may designate the same
individual as a representative on more than one Committee or Working Group. Each
representative of a Party on a Committee or Working Group shall be subject to
confidentiality obligations no less stringent than those in ARTICLE 9.

 

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2.7. Meetings of the Committees and Working Groups. Each Committee and Working
Group shall hold meetings at such times as such Committee or Working Group shall
determine, but in no event shall such meetings of the JSC, JDC, JCC and JMAC be
held less frequently than [**] during the Term for so long as each such
Committee exists unless the applicable Committee otherwise agrees. A Party may
also request that a special meeting of a Committee or Working Group be convened
for the purpose of reviewing or making a decision pertaining to any matter
within the purview of such Committee or Working Group by providing written
notice to the other Party. Such special meeting shall be convened at such time
as may be mutually agreed upon by the Parties, but in any event shall be held
within [**] days after the date of such notice. Each Committee and Working Group
may meet in person or by audio or video conference as its representatives may
mutually agree; provided, that the JSC, JDC, JCC and JMAC shall meet in person
at least [**] during the Term for so long as such Committee exists, unless the
Parties agree otherwise. In-person meetings of a Committee or Working Group
shall be held at a location selected by a Party, with the choice alternating
between Infinity and AbbVie with respect to each Committee or Working Group.
Other representatives of the Parties, their Affiliates and Third Parties
involved in the Development, Manufacture or Commercialization of the Products
may be invited by the members of a Committee or Working Group to attend meetings
of such Committee or Working Group as non-voting observers; provided, that, such
representatives are subject to confidentiality obligations no less stringent
than those in ARTICLE 9; provided further, that each representative appointed by
a Party to take action at a meeting of a Committee or Working Group shall have
sufficient authority to execute such action on behalf of such Party. Any
Committee or Working Group may upon agreement meet on an ad hoc basis between
regularly scheduled meetings in order to address and resolve time-sensitive
issues within their purview that may arise from time to time. No action taken at
a meeting of a Committee or Working Group shall be effective unless at least one
representative of each Party is present or participating. Neither Party shall
unreasonably withhold attendance of at least one representative of such Party at
any meeting of a Committee or Working Group for which reasonable advance notice
was provided. For clarity, Working Groups shall make decisions only to the
extent authorized to do so by the Committee to which such Working Group reports
to the extent such authorization is within the scope of responsibilities of such
Committee. In addition, notwithstanding anything to the contrary in this
Section 2.7 or in Sections 2.9, 14.4 or 14.5, any Committee can make a decision
within its purview upon written agreement of the co-chairpersons of such
Committee, which may include an e-mail chain in which each co-chairperson (or
designee described in Section 2.6) agrees to the relevant decision and which
e-mail chain includes a courtesy copy to the Alliance Managers and which e-mail
chain shall be maintained with the minutes of such Committee.

2.8. Discontinuation of Participation on a Committee. Each Committee and Working
Group shall continue to exist until the Parties mutually agree to disband the
Committee or Working Group.

2.9. Decision-Making.

2.9.1. Escalation to JSC. In conducting its activities, each Committee and
Working Group shall operate and make decisions consistent with the terms of this
Agreement. With respect to decisions of each Committee or Working Group, each
Party shall have one vote which shall be cast by such Party’s chairperson (or
designee described in Section 2.6) on such Committee or Working Group regardless
of the number of representatives from each Party. Should any Working Group not
be able to reach agreement on any matter that is within its purview under this
Agreement and a Party, or its representatives on such Working Group, requests a
resolution, the matter shall be

 

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referred to the Committee to which such Working Group reports. Should the JDC,
JCC or JMAC not be able to reach agreement on any matter that is within its
purview under this Agreement at a meeting of such Committee at which such matter
is considered and a Party, or its representatives on such Committee, requests a
resolution, the matter shall be referred to the JSC.

2.9.2. Escalation to Executive Officers. Should the JSC not be able to reach
agreement within [**] days after the JSC begins considering such matter at a
duly called meeting of the JSC, either with respect to any matter referred to it
by the JDC or JCC, or with respect to a matter initially arising within the JSC,
either Party may refer the matter to the Executive Officers for resolution. The
Executive Officers shall attempt to resolve the matter in good faith. If the
Executive Officers fail to resolve such matter within [**] Business Days after
the date on which the matter is referred to the Executive Officers (unless a
longer period is agreed to by the Parties), then such disputes or decisions
shall be resolved according to Section 2.9.3.

2.9.3. Final Decision-Making. Should the Executive Officers not be able to reach
agreement with respect to any matter referred to them by the JSC pursuant to
Section 2.9.2, such matter shall be resolved pursuant to Sections 13.1-13.11,
except as follows (the matters described in clauses (a) - (h) below, the
“Excluded Matters”):

(a) Except where specifically allocated in clauses (b) through (h) of this
Section 2.9.3, decisions regarding (i) Development of Products specifically
subject to approval by the JDC or JSC under this Agreement, including the global
regulatory strategy and Development of Combination Products,
(ii) Commercialization of Products specifically subject to approval by the JCC
or JSC under this Agreement, including Commercialization of Combination
Products, subject to Section 4.1.6, (iii) Medical Affairs Activities regarding
Products specifically subject to approval by the JMAC or JSC under this
Agreement, (iv) Research activities with respect to the Licensed Compound, and
(v) whether or not an AbbVie Withholding Tax Action represents the only
commercially reasonable alternative to Commercialize a Product shall in each
case ((i) through (v)) require mutual agreement of the Parties (or the Parties’
respective representatives on the applicable Committee). If the Parties are
unable to mutually agree upon any such matter, then neither Party shall have the
right to resolve the matter over the objection of the other Party, the matter
shall remain unresolved unless and until agreed upon by the JSC, and shall not
be subject to resolution pursuant to ARTICLE 13;

(b) Except where specifically allocated to a Party in clauses (c) through (h) of
this Section 2.9.3, decisions regarding (i) the Global Branding Strategy,
(ii) the US Commercialization Plan, including the US Commercialization Budget
(iii) the Sales Force Deployment Plan, and (iv) the MSL Deployment Plan for the
Territory shall be resolved pursuant to Section 13.13.

(c) AbbVie’s Executive Officer shall have the deciding vote with respect to the
following Commercialization matters to the extent related to the US
Commercialization Plan in the US Territory, consistent with the Global Branding
Strategy: (i) the promotional and educational materials for the Product;
(ii) Sales Representative training materials related to the Product;
(iii) managed care pricing activities and contracting, including final managed
care pricing decisions consistent with each of the following: the established
Product list price, targeted net pricing, sales-weighted average discounts and
rebates, and pricing strategy (including, without limitation, the approach to
pricing with different types of accounts and plans, including types of discounts
and rebates) and (iv) HECOR;

 

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(d) Infinity’s Executive Officer shall have the deciding vote with respect to
the following Commercialization matters to the extent related to the US
Commercialization Plan in the US Territory, consistent with the Global Branding
Strategy: (i) distribution and patient services, (ii) contracting with
advertising agencies and public relations firms, (iii) Product list price,
targeted net pricing, sales-weighted average discounts and rebates, pricing
strategy (including, without limitation, the approach to pricing with different
types of accounts and plans, including types of discounts and rebates) and
modifications to any of the foregoing, and (iv) commercial advisory boards;

(e) With respect to Medical Affairs Activities, (i) if such activities relate to
the support of a Clinical Study under the GDP, the Executive Officer of the
Party conducting such study will have the deciding vote with respect to such
support activities on a global basis, including the publication of data
resulting from such Clinical Study consistent with the Global Publication
Strategy, (ii) AbbVie’s Executive Officer will have the deciding vote with
respect to (A) approval, funding and other support for Investigator Sponsored
Clinical Studies which include AbbVie Combination Compound in the US Territory,
including publication of the resulting data, (B) all Investigator Sponsored
Clinical Studies in the Ex-US Territory, including publication of the resulting
data, (C) physician education activities under the Medical Affairs Plan and
(D) medical affairs support of managed care activities and (iii) Infinity’s
Executive Officer will have the deciding vote with respect to (A) subject in all
respects to Section 4.2.3, approval, funding and other support for all
Investigator Sponsored Clinical Studies in the US Territory other than
Investigator Sponsored Clinical Studies which include AbbVie Combination
Compound, including publication of the resulting data and (B) development
advisory boards (unless specific to a Clinical Study, in which case the
Executive Officer of the Party conducting such study will have the deciding
vote) and (C) Global Publication Strategy;

(f) AbbVie’s Executive Officer will have the deciding vote with respect to the
Ex-US Commercialization Plan;

(g) AbbVie’s Executive Officer will have the deciding vote with respect to all
matters relating to or involving the AbbVie Combination Compound (other than as
to any Combination Product comprising the Abbvie Combination Compound and the
Licensed Compound as set forth in Section 5.5.5) and, should Abbvie obtain the
right to conduct such Clinical Studies pursuant to Section 4.1.6, the Clinical
Studies that include the AbbVie Combination Compound, including companion
diagnostics for the AbbVie Combination Compound or a combination of the Licensed
Compound and the AbbVie Combination Compound, all of which such Clinical Studies
shall nonetheless be set forth in the GDP, subject to approval of the JDC, and
governed by Section 2.9.3(a); and

(h) Infinity’s Executive Officer shall have the deciding vote on all clinical
and commercial Manufacturing-related matters until the Parties transition
Manufacturing responsibility to AbbVie pursuant to Section 6.1.1, after which
transition AbbVie’s Executive Officer shall have the deciding vote on all
Manufacturing-related matters.

 

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2.9.4. Limitations.

(a) For clarity, any decision that is specified in this Agreement to be made by
a Party or by both Parties (i.e., rather than by a Committee or a Working
Group), including matters expressly subject to the mutual agreement of the
Parties, shall not be subject to resolution by a Committee or Working Group or
pursuant to ARTICLE 13.

(b) Notwithstanding anything to the contrary in Section 2.9.3, no Committee or
Working Group shall have the authority to amend this Agreement.

(c) Notwithstanding anything to the contrary in Section 2.9.3, neither Party
shall exercise its right to finally resolve a matter pursuant to Section 2.9.3:
(i) in a manner that excuses such Party from any of its obligations specifically
enumerated under this Agreement or any Related Agreement; (ii) in a manner that
negates any consent rights or other rights specifically allocated to the other
Party under this Agreement or any Related Agreement; (iii) in a manner that
would cause the other Party to breach an Infinity Third Party Agreement or
AbbVie Third Party Agreement, as applicable, to require any Third Party
counterparty to any such Third Party agreement to take any actions not required
to be performed by such Third Party under such Third Party agreement; (iv) in a
manner that would require the other Party to perform any act that it reasonably
believes to be inconsistent with any Law or any approval, order, policy or
guidelines of a Regulatory Authority and the relevant Party shall promptly
provide notice of such belief to the other Party; or (v) in a manner that would
infringe or misappropriate a Third Party’s Patent Rights, Know-How or trademark
rights. In addition, in resolving a dispute pursuant to Section 2.9.3, the
deciding Party shall act in good faith.

2.10. Alliance Managers. Within [**] days after the Effective Date, each Party
shall designate a single alliance manager for all of the activities contemplated
under this Agreement (each, an “Alliance Manager”). Each Party’s Alliance
Manager may attend all meetings of each Committee or Working Group as a
non-voting participant. The Alliance Managers will be responsible for the
day-to-day worldwide coordination of the Parties’ activities under this
Agreement, will serve to facilitate communication between the Parties, will
serve as a first point of contact as it relates to resolution of any dispute in
accordance with the procedures outlined herein. The Alliance Managers shall have
a general understanding of Development and Commercialization and knowledge
appropriate for managers with such alliance management responsibilities. Each
Party may change its designated Alliance Manager from time to time upon notice
to the other Party.

ARTICLE 3.

LICENSE GRANTS

3.1. Infinity Grants.

3.1.1. Development License. Subject to the terms and conditions of this
Agreement, Infinity hereby grants to AbbVie a co-exclusive (with Infinity,
solely to the extent set forth in Section 3.1.5) license under the Infinity
Intellectual Property to Develop and have Developed the Licensed Compounds and
Products in the Field in the Territory, in accordance with the GDP, which
license shall be sublicensable to the extent set forth in Section 3.6.

 

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3.1.2. Manufacturing License. Subject to the terms and conditions of this
Agreement, Infinity hereby grants to AbbVie a co-exclusive (with Infinity,
solely to the extent set forth in Section 3.1.5) license under the Infinity
Intellectual Property to Manufacture and have Manufactured the Licensed
Compounds and Products in the Field for use or sale in the Territory in
accordance with this Agreement and any Supply Agreement, which license shall be
sublicensable to the extent set forth in Section 3.6.

3.1.3. Commercialization License. Subject to the terms and conditions of this
Agreement, Infinity hereby grants to AbbVie (a) a co-exclusive license (with
Infinity, solely to the extent set forth in Section 3.1.5) under the Infinity
Intellectual Property to Commercialize Products in the Field in the US Territory
in accordance with the US Commercialization Plan, and (b) an exclusive license,
even as to Infinity, under the Infinity Intellectual Property to Commercialize
Products in the Field in the Ex-US Territory in accordance with the Ex-US
Commercialization Plan, which license shall be sublicensable to the extent set
forth in Section 3.6.

3.1.4. Trademark License. Subject to the terms and conditions of this Agreement,
Infinity hereby grants to AbbVie a royalty-free, fully paid up, co-exclusive
(with Infinity, solely to the extent set forth in Section 3.1.5), license to use
the Product Trademarks and Internet domain names described in Section 8.7.2 and
owned by Infinity, solely for the purposes of conducting Development activities
with respect to the Products in the Field in the Territory in accordance with
the GDP and Commercializing the Products in the Field in the Territory in
accordance with the applicable Commercialization Plan, which license shall be
sublicensable to the extent set forth in Section 3.6.

3.1.5. Retained Rights; Bankruptcy Code § 365(n) Election. Subject to the terms
and conditions of this Agreement, with respect to each license granted pursuant
to Sections 3.1.1 through 3.1.4, Infinity shall retain the right, itself or
through its Affiliates, subcontractors or Sublicensees, solely to perform those
activities (if any) to the extent allocated to Infinity, and exercise Infinity’s
rights, under this Agreement, the GDP, the Medical Affairs Plan, the US
Commercialization Plan and any Related Agreement, or as requested by AbbVie or
its Affiliate. AbbVie’s licenses granted pursuant to Sections 3.1.1, 3.1.3 and
3.1.4 are limited to the conduct of only those activities which, as of such
time, are assigned to AbbVie under the GDP or any Commercialization Plan;
provided that, following any rejection of this Agreement or any Related
Agreement by Infinity and election by AbbVie to retain its license rights
hereunder pursuant to Bankruptcy Code § 365(n), AbbVie shall have the right to
perform all activities otherwise allocated as of such time to Infinity, it being
understood that such reallocation of activities shall not change or disturb the
royalty payments, if any, payable to Infinity pursuant to Bankruptcy Code §
365(n). Following any such rejection and election by AbbVie, and notwithstanding
Section 2.9.3 hereof, AbbVie shall have the right to amend the GDP, the Medical
Affairs Plan or any Commercialization Plan without the need to propose any such
amendment to any Committee hereunder and without the need to obtain any
agreement or consent of Infinity hereunder, and may otherwise exercise its
rights under the licenses granted in Sections 3.1.1 through 3.1.4 consistent
with the scope of the licenses granted under those Sections.

 

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3.1.6. Third Party Rights. Notwithstanding anything to the contrary herein, the
rights, licenses and sublicenses granted by Infinity to AbbVie in this Agreement
or any Related Agreement are subject to the terms and conditions of the
applicable Infinity Third Party Agreements, and the rights granted to or
retained by the counterparties thereunder or their licensors.

3.2. AbbVie Grants.

3.2.1. Development License. Subject to the terms and conditions of this
Agreement, AbbVie hereby grants to Infinity a co-exclusive (with AbbVie, solely
to the extent set forth in Section 3.2.5) license under the AbbVie Intellectual
Property to Develop and have Developed the Licensed Compounds and Products in
the Field in the Territory, in accordance with the GDP, which license shall be
sublicensable to the extent set forth in Section 3.6.

3.2.2. Manufacturing License. Subject to the terms and conditions of this
Agreement, AbbVie hereby grants to Infinity a co-exclusive license (with AbbVie,
solely to the extent set forth in Section 3.2.5) under the AbbVie Intellectual
Property to Manufacture and have Manufactured the Licensed Compounds and
Products in the Field for use or sale in the Territory in accordance with this
Agreement and any Supply Agreements, which license shall be sublicensable to the
extent set forth in Section 3.6.

3.2.3. Commercialization License. Subject to the terms and conditions of this
Agreement, AbbVie hereby grants to Infinity a co-exclusive (with AbbVie, solely
to the extent set forth in Section 3.2.5) license under the AbbVie Intellectual
Property to Commercialize Products in the Field in the US Territory in
accordance with the US Commercialization Plan, which license shall be
sublicensable to the extent set forth in Section 3.6.

3.2.4. [**]. Subject to the terms and conditions of this Agreement, AbbVie
hereby grants to Infinity a [**] to make, have made, import, export, use, have
used, sell, have sold, or offer for sale, including to develop, commercialize,
register, modify, enhance, improve, manufacture, have manufactured, hold, or
keep (whether for disposal or otherwise), or otherwise dispose of [**].

3.2.5. Retained Rights; Bankruptcy Code § 365(n) Election. Subject to the terms
and conditions of this Agreement, with respect to each license granted pursuant
to Sections 3.2.1 through 3.2.4, AbbVie shall retain the right, itself or
through its Affiliates, subcontractors or Sublicensees, solely to perform such
activities (if any) to the extent allocated to AbbVie, and exercise AbbVie’s
rights, under this Agreement, the GDP, the Medical Affairs Plan, each
Commercialization Plan and any Related Agreement, or as requested by Infinity or
its Affiliate. Infinity’s Exploitation of the licenses granted pursuant to
Section 3.2.1 through Section 3.2.4 are limited to the conduct of only those
activities which, as of such time, are assigned to Infinity under the GDP or any
Commercialization Plan; provided that, following any rejection of this Agreement
or any Related Agreement by AbbVie and election by Infinity to retain its
license rights hereunder pursuant to § 365(n), Infinity shall have the right to
perform all activities otherwise allocated as of such time to AbbVie, it being
understood that such reallocation of activities shall not change or disturb the
royalty payments, if any, payable to AbbVie pursuant to Bankruptcy Code §
365(n). Following any such rejection and election by Infinity, and
notwithstanding Section 2.9.3 hereof, Infinity shall have the right to amend the
GDP, the Medical Affairs Plan or any Commercialization Plan without the need to
propose any such amendment to any Committee hereunder and without the need to
obtain any agreement or consent of AbbVie hereunder, and may otherwise exercise
its rights under the licenses granted in Sections 3.2.1 through 3.2.4 consistent
with the scope of the licenses granted under those Sections; provided that,
Infinity shall in no instance have the right to conduct any Clinical Studies
involving the AbbVie Combination Compound.

 

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3.3. Provision of Information. During the Term, each Party will make available
to the other Party all Regulatory Filings and Infinity Know-How or AbbVie
Know-How, as applicable, in its possession or Control related to the Licensed
Compound or the Product as reasonably necessary or useful to Develop,
Manufacture and Commercialize the Licensed Compound or the Product under this
Agreement.

3.4. Joint Patent Rights. Subject to the provisions of Sections 3.1, 3.2 and
3.7, and to the extent not already granted herein, each Party hereby grants, and
shall cause its Affiliates to grant, to the other Party a worldwide,
non-exclusive, royalty-free, fully paid up, freely sublicensable right and
license to exploit the Joint Patent Rights in any manner without compensating or
accounting to the other Party (or its Affiliates).

3.5. Blocking Third Party Intellectual Property.

3.5.1. Certain Blocking Third Party Intellectual Property. If, during the Term,
a Party believes, in its reasonable judgment, that it may be necessary to obtain
rights under any Blocking Third Party Intellectual Property in order to Develop,
Manufacture or Commercialize a Product in the Field in accordance with this
Agreement, said Party shall promptly call a meeting of the IP Working Group, and
the Parties, through the IP Working Group, shall discuss such matter, including
whether a license under such Blocking Third Party Intellectual Property would be
necessary.

(a) If the IP Working Group [**] in accordance with this Agreement or the IP
Working Group [**], and the IP Working Group [**], the [**] shall use Diligent
Efforts to obtain a sublicensable license under, or acquire, such Blocking Third
Party Intellectual Property from the relevant Third Party, and, in connection
with obtaining such a license to or acquiring such Blocking Third Party
Intellectual Property, [**] will, where possible, provide to [**] drafts of any
such license or acquisition agreement reasonably in advance of providing such
drafts to the applicable Third Party and will incorporate all reasonable
comments [**] in such draft.

(b) If the IP Working Group [**], then [**] shall have the right to do so for
this Product, in which case Section 3.5.2 would apply to such rights and [**]
shall use diligent efforts to [**].

(c) If the IP Working Group [**], but the IP Working Group [**] then [**], to
obtain a sublicensable license under, or acquire, such Blocking Third Party
Intellectual Property from the relevant Third Party and, [**] licenses or
acquires such rights, and the costs incurred [**] under such license or for such
acquisition shall be allocated as described in sub-section (e) below. If [**]
elects not to obtain such a license or is unable to obtain such a license, [**],
to obtain a sublicensable license under, or acquire, such Blocking Third Party
Intellectual Property from the relevant Third Party, and the costs incurred [**]
under such license or for such acquisition shall be allocated as described in
sub-section (e) below.

 

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(d) If Infinity licenses or acquires such rights under this Section 3.5.1,
(i) Infinity’s (or its relevant Affiliate’s) agreement(s) with such Third Party
with respect to such Blocking Third Party Intellectual Property shall be
considered Infinity Third Party Agreement(s), (ii) Infinity shall promptly
provide a copy of such Infinity Third Party Agreement(s) to AbbVie, (iii) the
Blocking Third Party Intellectual Property Controlled by Infinity as a result of
such Infinity Third Party Agreement(s) shall be considered Infinity Intellectual
Property, (iv) all rights and obligations under this Agreement with respect to
such Infinity Intellectual Property shall be subject to such Infinity Third
Party Agreement(s) and (v) any payments with respect thereto shall be considered
Infinity Third Party Agreement Payments. If AbbVie licenses or acquires such
rights under this Section 3.5.1, (v) AbbVie’s (or its relevant Affiliate’s)
agreement(s) with such Third Party with respect to such Blocking Third Party
Intellectual Property shall be considered AbbVie Third Party Agreement(s),
(w) AbbVie shall promptly provide a copy of such AbbVie Third Party Agreement(s)
to Infinity, (w) such Blocking Third Party Intellectual Property shall be
considered AbbVie Intellectual Property, (x) all rights and obligations under
this Agreement with respect to such AbbVie Intellectual Property shall be
subject to such AbbVie’s Third Party Agreement(s), (y), and (z) [**].

(e) All Infinity Third Party Agreement Payments and Blocking Third Party
Intellectual Property Costs that arise out of the Development or
Commercialization of any Licensed Compound or Product under this Agreement, in
either case that are incurred by Parties that relate solely to the US Territory
(e.g., royalties on sales in the US Territory or milestone payments for events
in the US) will be included in Allowable Expenses and shared between the Parties
accordingly, and the IP Working Group will determine [**]. The [**] determined
by the IP Working pursuant to the preceding sentence will be included in
Allowable Expenses or reimbursed accordingly. In the event that the IP Working
Group is unable to reach agreement [**], the matter shall be referred to a [**],
each Party shall provide to such Third Party all information in its control
necessary for such Third Party to resolve such matter, and [**]. AbbVie shall
reimburse Infinity for all Infinity Third Party Agreement Payments that relate
to the Ex-US Territory that Infinity incurs pursuant to Section 7.4.1, except
that, for clarity, Infinity shall be solely responsible for all royalty payments
arising under an Existing Infinity Third Party Agreement as a result of the sale
of Products in the Ex-US Territory by AbbVie or its Affiliates or Sublicensees.
Schedule 3.5.1 sets forth all non-royalty payments under Existing Infinity Third
Party Agreements not yet paid by Infinity as of the Effective Date. The Finance
Working Group shall ensure that the necessary information and payments are
received by a Party from the other Party sufficiently in advance of the date(s)
on which such information and payments are due to the relevant Third Party
counterparty under an Infinity Third Party Agreement or AbbVie Third Party
Agreement to avoid a breach of such Infinity Third Party Agreement or AbbVie
Third Party Agreement. All Blocking Third Party Intellectual Property Costs
incurred by AbbVie that relate solely to the US Territory will be included in
Allowable Expenses and shared between the Parties accordingly. Blocking Third
Party Intellectual Property Costs (including payments under AbbVie Third Party
Agreements and Infinity Third Party Agreement Payments pursuant to Section 3.5)
for the Ex-US Territory that are reimbursed by AbbVie shall be deducted and
recouped from royalties owed to Infinity in accordance with Section 7.3.3(d).

(f) If the Party other than the Party that acquires or obtains a license
pursuant to this Section 3.5.1 under Blocking Third Party Intellectual Property
determines that such Blocking Third Party Intellectual Property Covers one or
more technologies or products that are not Products, [**], the Parties shall
[**]; provided, however, that the [**], the Parties shall [**] this Agreement.

 

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3.5.2. [**] Third Party Blocking Intellectual Property. If, during the Term, a
Party obtains rights under any Blocking Third Party Intellectual Property (by
in-license, acquisition or otherwise) [**] in accordance with this Agreement,
said Party shall promptly call a meeting of the IP Working Group [**], provide a
summary of material terms with respect to such Blocking Third Party Intellectual
Property, and the Parties, through the IP Working Group, [**]. If the IP Working
Group determines that it would be [**], the Party that has obtained rights to
such Block Third Party Intellectual Property will provide a copy of the
agreement pursuant to which such Party has obtained such rights to the other
Party to the extent permitted by such agreement.

(a) If the IP Working Group determines that such Blocking Third Party
Intellectual Property [**] and such use of such Blocking Third Party
Intellectual Property with respect to a Product would give rise to any payments
to a Third Party in consideration for such use, then such Blocking Third Party
Intellectual Property [**]. If no such payments would arise in connection with
the use of the Blocking Third Party Intellectual Property with a Product, then
such Blocking Third Party Intellectual Property [**].

(b) In the event that the IP Working Group determines [**], the matter shall be
referred to a mutually agreed upon Third Party expert in the valuation of life
sciences assets, who shall determine [**]. Each Party shall provide to such
Third Party all information in its control necessary for such Third Party to
resolve such matter, and the costs for such expert shall be borne equally by the
Parties.

3.5.3. [**].

3.6. Sublicensing and Subcontracting.

3.6.1. AbbVie Right to Sublicense. AbbVie shall have the right to grant
sublicenses (through multiple tiers) to its Affiliates or Third Parties of any
and all rights granted to AbbVie under this Agreement by Infinity pursuant to
Section 3.1 or licenses to its Affiliates or Third Parties of rights retained by
AbbVie with respect to Licensed Compounds and Products in the Field. If AbbVie
grants any sublicense pursuant to this Section 3.6.1, AbbVie shall remain
responsible for its obligations under this Agreement and shall be responsible
for the performance of the relevant Sublicensee. In addition, AbbVie shall
ensure that each of its Sublicensees complies with all relevant provisions of
this Agreement.

3.6.2. Infinity Right to Sublicense. Infinity shall have the right to grant
sublicenses (through multiple tiers) to its Affiliates or Third Parties of any
and all rights granted to Infinity under this Agreement by AbbVie pursuant to
Section 3.2 or licenses to its Affiliates or Third Parties of rights retained by
Infinity with respect to Licensed Compounds and Products in the Field. If
Infinity grants any sublicense pursuant to this Section 3.6.2, Infinity shall
remain responsible for its obligations under this Agreement and shall be
responsible for the performance of the relevant Sublicensee. In addition,
Infinity shall ensure that each of its Sublicensees complies with all relevant
provisions of this Agreement.

3.6.3. Sublicense Requirements. Each license or sublicense granted by a Party to
an Affiliate or a Third Party (including any subcontractor) pursuant to
Section 3.6.1 or 3.6.2 (a “Sublicense”) shall be in writing and shall be
consistent with the relevant restrictions and limitations set forth in this
Agreement. No Sublicense or subcontract shall diminish, reduce or eliminate any
obligation of either Party under this Agreement.

 

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3.7. Exclusivity Covenants.

3.7.1. Infinity Covenant.

(a) During the Term, except pursuant to and in accordance with the terms of this
Agreement or any Related Agreement, neither Infinity nor any of its Affiliates
(subject to Section (b)) shall directly or indirectly (i) Commercialize any
Competing Product in the Field in the Territory, nor collaborate with, license,
sell to or enable or otherwise authorize, permit or grant any right to any Third
Party to Commercialize any Competing Product in the Field in the Territory;
(ii) Develop the Licensed Compound or Product outside of the Field beyond the
completion of Phase II Studies (or beyond Phase I Studies if it is contemplated
that such Phase II Studies will or may be used as pivotal, registration directed
studies); or (iii) Commercialize the Licensed Compound or Products outside the
Field in the Territory, nor collaborate with, license, sell to or enable or
otherwise authorize, permit or grant any right to any Third Party to
Commercialize the Licensed Compound or Products outside the Field in the
Territory.

(b) Notwithstanding the provisions of Section 3.7.1(a), if, during the Term,
(i) Infinity or any of its Affiliates acquires, as the result of an Acquisition
Transaction (other than a Change of Control), rights to a Competing Product,
[**]; or (ii) Infinity undergoes a Change of Control and the relevant acquirer
is either then Commercializing a Competing Product in the Field or has in
development any Competing Product in the Field, such Acquisition Transaction,
and the Commercialization (or development and subsequent Commercialization, if
such Competing Product is approved) of such Competing Product in the Field by
such relevant acquirer or any of its Affiliates, [**]. If following an
Acquisition Transaction that is not a Change of Control, [**].

3.7.2. AbbVie Covenant.

(a) During the Term, except pursuant to and in accordance with the terms of this
Agreement or any Related Agreement, neither AbbVie nor any of its Affiliates
shall directly or indirectly Commercialize any Competing Product in the Field in
the Territory, nor collaborate with, license, sell to, enable or otherwise
authorize, permit or grant any right to any Third Party to Commercialize any
Competing Product in the Field in the Territory.

(b) Notwithstanding the provisions of Section 3.7.2(a), if, during the Term,
(i) AbbVie or any of its Affiliates acquires, as the result of an Acquisition
Transaction (other than a Change of Control), rights to a Competing Product such
Acquisition Transaction, and [**]; or (ii) if AbbVie undergoes a Change of
Control and the relevant acquirer is either then Commercializing a Competing
Product in the Field, or has in development any Competing Product in the Field,
such Acquisition Transaction, and the Commercialization (or development and
subsequent Commercialization, if such Competing Product is approved) of such
Competing Product in the Field by such acquiring Affiliate, [**]. If following
an Acquisition Transaction that is not a Change of Control, [**].

 

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3.7.3. Definitions. As used in this Section 3.7,

(a) “Acquisition Transaction” means (i) a Change of Control of a Party, (ii) any
acquisition of all or substantially all of the assets of a Third Party relating
to a Competing Product, or the acquisition of control (as defined in
Section 1.10) of a Third Party, or (iii) a merger or consolidation of a Party
with or of a Third Party that is not a Change of Control of such Party;

(b) “Competing Product” means [**];

(c) “[**]” means (i) [**]; and

(d) “[**]” means, with respect to a Competing Product, [**].

3.7.4. Section 365(n) of the Bankruptcy Code. All rights and licenses granted
under or pursuant to any section of this Agreement, including Section 3.1, are
rights to “intellectual property” (as defined in Section 101(35A) of Title 11 of
the United States Code (the “Bankruptcy Code”)) and the Parties hereby
acknowledge, on behalf of themselves and their respective Affiliates, that such
“intellectual property” includes (a) laboratory samples, (b) Product samples and
inventory, (c) laboratory notes and notebooks, (d) Data and results related to
Clinical Studies, (e) Regulatory Filings and Regulatory Approvals, (f) rights of
reference in respect of Regulatory Filings and Regulatory Approvals, and
(g) marketing, advertising and Promotional Materials. The Parties agree that
each Party, as a licensee of such rights under this Agreement, will retain and
may fully exercise all of its rights and elections under the Bankruptcy Code.
The Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against either Party under the Bankruptcy Code, then the Party
that is not a party to such proceeding will be entitled to a complete duplicate
of (or complete access to, as appropriate) any such intellectual property and
all embodiments of such intellectual property, and the same, if not already in
its possession, will be promptly delivered to it (y) upon any such commencement
of a bankruptcy proceeding upon written request therefor, if such Party subject
to such proceeding fails to perform all of its obligations under this Agreement
and the Related Agreements, or (z) if not delivered under subsection (y) above,
following the rejection of this Agreement by or on behalf of the Party subject
to such proceeding upon written request therefor by the non-subject Party, and,
with respect to clauses (y) or (z), the “royalty payments” due with respect to
the United States from AbbVie as the non-subject Party in accordance with
Section 365(n) of the Bankruptcy Code shall be fifty percent (50%) of the Net
Profit or Loss, and the “royalty payments” due with respect to the United States
from Infinity as the non-subject Party in accordance with Section 365(n) of the
Bankruptcy Code shall be fifty percent (50%) of the Net Profit or Loss; provided
that, for purposes of calculating such royalty payments in accordance with
Section 365(n) of the Bankruptcy Code, fifty percent (50%) of any Net Profits or
Loss, to the extent less than zero and not reconciled and paid in any Calendar
Quarter pursuant to Section 7.2.2, shall be credited against any such royalty
payments owed to the other Party following any such Calendar Quarter.

3.8. Reservation of Rights.

3.8.1. No rights, other than those expressly set forth in this Agreement are
granted to either Party hereunder, and no additional rights shall be deemed
granted to either Party by implication, estoppel or otherwise, with respect to
any intellectual property rights. All rights not expressly granted by either
Party or its Affiliates to the other hereunder are reserved.

 

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3.8.2. Infinity agrees not to practice any AbbVie Intellectual Property except
pursuant to the licenses expressly granted to Infinity in this Agreement (it
being agreed that no such license grants any right to Research any compound or
product, or to Develop, have Developed, Manufacture, have Manufactured, use,
sell, offer to sell, otherwise Commercialize or import any compounds and
products containing or comprising any compound, other than Licensed Compounds
and Products in the Field to the extent set forth herein).

3.8.3. AbbVie agrees not to practice any Infinity Intellectual Property except
pursuant to the licenses expressly granted to AbbVie in this Agreement (it being
agreed that no such license grants any right to Research any compound or
product, or to Develop, have Developed, Manufacture, have Manufactured, use,
sell, offer to sell, otherwise Commercialize or import any compounds and
products containing or comprising any compound, other than Licensed Compounds
and Products in the Field to the extent set forth herein).

ARTICLE 4.

DEVELOPMENT

4.1. GDP; Amendments; Development Responsibilities.

4.1.1. Global Development Plan. The global Development of the Products shall be
governed by the GDP, and the Parties agree to conduct all of their (and their
Affiliates’) Development activities relating to the Products in accordance with
the GDP. The initial approved GDP is attached hereto as Exhibit C. The GDP shall
include, with respect to the Licensed Compound and Products, the strategy for
global Development and for obtaining Regulatory Approval, guidelines for
additional data or criteria, high-level study design criteria, e.g. indication,
line of therapy, approximate patient numbers, primary trial endpoints (it being
understood that the Party conducing a Clinical Study shall have final
decision-making authority with respect to decisions regarding the implementation
of such Clinical Study on matters such as investigator and site selection
consistent with the GDP) if any, to be generated for assessment prior to
Commencement of any specific Clinical Study, allocation of responsibilities
between the Parties, timelines, the Development Budget, translational medicine
activities, and thought leader activities, (it being understood that the initial
GDP does not include all of the requirements set forth in this Section 4.1.1).
The GDP shall be consistent with the terms of this Agreement and shall be
sufficient to permit Infinity to comply with its obligations under each of the
Infinity Third Party Agreements. The activities set forth in the GDP shall at
all times be designed to be in compliance with all applicable Laws. Each GDP
shall include a mutually agreed upon, rolling plan for Developing the Products
and shall be prepared in good faith. The Parties agree to pursue in good faith
and fund the Development Costs of any Clinical Study set forth in the GDP to the
extent required under this Agreement, regardless of the Calendar Year in which
such Clinical Study Commences.

4.1.2. Development Principles. The Development of Products in the Field will be
conducted in accordance with the following principles, except to the extent (if
any) otherwise expressly provided in the GDP, and the JDC (or the JSC, or the
Executive Officers, as applicable) shall take into account and attempt to
implement the following principles in its decision-making, including
preparation, review and approval of any updates to and amendments of the GDP:

 

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(a) Regardless of the specific division of responsibility between the Parties
for particular activities at any particular time, the JDC shall serve as a
conduit for sharing information, knowledge and expertise relating to the
Development of the Product;

(b) Clinical development of, and translational medicine for, Licensed Compounds
and Products should be performed only in accordance with the GDP; and

(c) The Parties shall cooperate (and cause their Affiliates and use Diligent
Efforts to cause any Sublicensees to cooperate) to facilitate the on-going
transfer between the Parties of Infinity Know-How or AbbVie Know-How to allow
both Parties (or their Affiliates) to use such Know-How in the Development and
Manufacturing of Licensed Compounds and Products in accordance with this
Agreement and the Related Agreements, as applicable.

4.1.3. Development Budget. The Development Budget shall set forth the budgeted
amounts for Development Costs with respect to activities allocated to the
Parties under the GDP [**] thereafter and shall include for each Party a budget
for Development Costs for the Development activities allocated to such Party for
such period, broken down by Calendar Quarter with respect to the then-current
Calendar Year. The Development Budget shall also include a breakout of costs by
functional area or category as determined by the JDC. Concurrently with the
annual update of the GDP in accordance with Section 4.1.5, the JDC shall
prepare, and the JSC shall review and approve the updated Development Budget
included in such GDP.

4.1.4. Allocation of Development Activities.

(a) Subject to Section 4.1.6, the GDP shall allocate responsibility between the
Parties for the conduct of Clinical Studies and the various other Development
activities addressed in the GDP.

(b) The Party that has responsibility for conducting the Clinical Study shall
have the responsibility for the packaging of clinical drug supplies, unless
otherwise agreed by the Parties.

(c) Neither Party nor its Affiliates shall conduct any Clinical Study or other
Development of any Licensed Compound or Product in the Field, except as
expressly permitted in this ARTICLE 4.

4.1.5. Updating and Amending the GDP.

(a) The JDC shall review the GDP, including the Development Budget, not less
frequently than annually and shall develop detailed and specific GDP updates in
accordance with Section 4.1.1. The JDC shall meet no later than [**] of each
Calendar Year to prepare the updates to the GDP, and shall submit all such
updates to the JSC for review and approval, such that JSC preliminary approval
would occur no later than [**] of each Calendar Year. Upon the JSC’s preliminary
approval, such updates shall be submitted to each Party for its internal
budgeting process with a target for final approval by the JSC no later than [**]
of such Calendar Year, at which time the GDP shall be amended accordingly. If
the JSC does not approve an updated GDP, including the Development Budget, prior
to the start of the next Calendar Year, either Party may initiate procedures to
resolve the issue pursuant to Section 2.9, and the

 

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then-current GDP and Development Budget shall continue to apply until the
updated GDP is approved by the JSC. The JDC may also develop and submit to the
JSC from time to time other proposed amendments to the GDP. The JSC shall review
proposed amendments presented to the JDC and may approve such proposed
amendments or any other proposed amendments that the JSC may consider from time
to time in its discretion, and, upon such approval by the JSC, the GDP shall be
amended accordingly.

(b) This Section 4.1.5(b) shall be subject in its entirety to Section 4.1.1: If,
during any Calendar Year (the “First Year”), any Development activity expressly
provided for in the GDP to be completed during such First Year is not completed
during such First Year (to the extent incomplete, an “Incomplete Activity”) and
the full expense budgeted in the Development Budget for such activity for such
First Year is not incurred (to the extent not incurred, a “Non-Incurred
Amount”), then such Incomplete Activity shall be completed during Calendar Years
following such First Year (the “Succeeding Year(s)”) and the Non-Incurred Amount
shall be included in the Development Budget for such Succeeding Year(s) as
follows: If the Development Budget for such Succeeding Year(s) has not yet been
approved by the JSC, then the Non-Incurred Amount shall be included in the
proposed Development Budget for such Succeeding Year(s) without otherwise
limiting any other Development activities or any amounts related thereto,
unrelated to the Incomplete Activity, which, pursuant to the GDP, would have
been performed during such Succeeding Year(s), and if the Development Budget for
such Succeeding Year(s) has been approved by the JSC, then the Development
Budget for such Succeeding Year(s) shall be revised automatically to include the
Non-Incurred Amount.

4.1.6. Combination Clinical Studies.

(a) AbbVie shall be solely responsible for conducting the Clinical Studies
provided for in the GDP that involve or relate to the AbbVie Combination
Compound. AbbVie shall conduct such Clinical Studies only to the extent AbbVie
is able to do so without violating the terms of any AbbVie Third Party
Agreement, and, in such case, subject to the terms and conditions of such AbbVie
Third Party Agreement. [**]; provided, however, that AbbVie shall have no
obligation to (i) [**], (ii) [**], or (iii) [**].

(b) [**].

(c) [**], then the Parties shall [**] shall have [**] shall have [**] and shall
not be a[**] under this Agreement [**] and shall be [**], provided, that [**]
shall use [**] as of the Effective Date. Notwithstanding the foregoing, if [**].

(d) [**] nothing in this Agreement would prohibit Infinity from conducting such
study on its own outside of the scope of the GDP and this Agreement following
Regulatory Approval of the AbbVie Combination Compound, without limiting the
provisions governing the Licensed Compound herein, (including the exclusivity
covenants contained in Section 3.7); provided, that before Infinity Commences
such study, [**]. If Infinity conducts such a study, Infinity shall have final
decision -making authority with respect thereto, and AbbVie shall not be
obligated to reimburse Infinity for any of the costs associated with such study.

 

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4.2. Medical Affairs Activities.

4.2.1. Responsibilities. The Parties shall collaborate to conduct Medical
Affairs Activities in support of Products in the Field throughout the Territory
pursuant to the Medical Affairs Plan under the direction of the JMAC.

4.2.2. Medical Affairs Plan. The Medical Affairs Activities in support of
Products in the Territory shall be described in a reasonably comprehensive plan
(the “Medical Affairs Plan”) that describes the Medical Affairs Activities
throughout in the Territory, key tactics and strategies for implementing those
activities, the relative responsibilities of the Parties and the associated
budget for such activities (the “Medical Affairs Budget”). The JMAC shall
prepare an initial Medical Affairs Plan (with input from the JDC and JCC) for
review and approval by the JSC, no later than [**]. On an annual basis
thereafter, the JMAC shall meet no later than [**] of each Calendar Year to
update the Medical Affairs Plan and shall submit all such updates to the JSC for
review and approval, such that JSC preliminary approval would occur no later
than [**] of such Calendar Year. Upon the JSC’s preliminary approval, such
updates shall be submitted to each Party for its internal budgeting process with
a target for final approval by the JSC no later than [**] of such Calendar Year,
at which time such Medical Affairs Plan shall be amended accordingly. The JMAC
shall also reasonably consider for approval any proposed updates and amendments
to the Medical Affairs Plan presented by either Party. The JSC shall review such
proposed amendments presented by the JMAC and may approve such proposed
amendments or any other proposed amendments that the JSC may consider from time
to time and, upon such approval by the JSC, the Medical Affairs Plan shall be
amended accordingly.

4.2.3. Investigator Sponsored Clinical Studies. The Medical Affairs Plan and
Budget will include the strategy and allocated budget for Investigator Sponsored
Clinical Studies that the JMAC determines to conduct. Additional funding for
Investigator Sponsored Clinical Studies would require an amendment to the
Medical Affairs Budget and require approval by the JMAC. In the event that the
JMAC does not approve by consensus (notwithstanding Section 2.9.3) an
Investigator Sponsored Clinical Study that has been proposed for inclusion in
the Medical Affairs Plan and Medical Affairs Budget by either Party, then the
Party proposing such study may conduct such study on its own, and the Party
conducting such study shall be responsible for one hundred percent (100%) of the
costs of such study, without reimbursement from the other Party under Sections
4.2.7 and 4.2.8, unless the other Party objects in writing to the proposing
Party conducting such study within [**] Business Days of the JMAC’s failure to
reach consensus which objection may be made by the other Party in its sole
discretion. If one Party (the “Conducting Party”) does conduct such study at its
sole expense, and if the results of such study are used in a Regulatory Approval
Application that results in a Label Expansion or compendium expansion for the
applicable Product, then the other Party (the “Reimbursing Party”) shall
reimburse 100% of the Conducting Party’s Out-of-Pocket Costs and Development FTE
Costs to conduct such study through quarterly payments, commencing in the
Calendar Quarter in which such approval is received, [**] until such amounts are
fully paid; provided that if such amounts are not fully repaid within [**] years
after the first such payment, then the Reimbursing Party shall pay the
Conducting Party all remaining amounts due for such study under this
Section 4.2.3 at the conclusion of such [**] year. If Infinity is the
Reimbursing Party, then such payments shall be made, with respect to Net Sales
in the Ex-US Territory, through a deduction in royalties owed by AbbVie to
Infinity with respect to the Ex-US Territory, and, if AbbVie is the Reimbursing
Party, then such payments shall be made, with respect to Net Sales in the Ex-US
Territory, through an increase in royalties owned by AbbVie to Infinity with
respect to Net Sales in the Ex-US Territory. In the United States, Net

 

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Profit and Net Loss for the Reimbursing Party shall be appropriately adjusted to
reflect such payment. In the event that[**], then following Regulatory Approval
of the AbbVie Combination Compound, nothing in this Agreement would prohibit
Infinity from conducting such study on its own outside of the scope of the GDP
and this Agreement following Regulatory Approval of the AbbVie Combination
Compound, without limiting the provisions governing the Licensed Compound herein
(including the exclusivity covenants contained in Section 3.7), as provided in
Section 4.1.6, and AbbVie shall not be obligated to reimburse Infinity with
respect to such study as provided in this Section 4.2.3; provided, that prior to
Commencing such study on its own, [**].

4.2.4. Medical Affairs Reports. At each meeting of the JMAC (or invited JDC or
JCC agenda-driven meeting), each Party will report on the Medical Affairs
Activities such Party and its Affiliates have performed with respect to Products
in the Field since the last meeting of the JMAC, evaluate the work performed in
relation to the goals of the Medical Affairs Plan and provide such other
information as may be reasonably requested by the JSC with respect to such
Medical Affairs Activities.

4.2.5. MSLs. Infinity and AbbVie will each have the right to provide MSLs to
support Products in the Territory, on a Product-by-Product basis. Each Party
shall have the right to provide up to fifty percent (50%) of the MSL FTEs with
respect to each such Product in the Territory, as further specified in the
Medical Affairs Plan. The JMAC shall create a MSL Deployment Plan for each of
the United States and the Ex-US Territory as determined by the JMAC, and each
MSL Deployment Plan will be included in the Medical Affairs Plan. Each MSL
Deployment Plan will be consistent with the then-current Medical Affairs Plan.
The JMAC shall review and oversee the Parties’ MSL activities in the Territory.

4.2.6. Medical Affairs Standards of Conduct. Each Party shall use Diligent
Efforts to execute and to perform, or cause to be performed, the activities
assigned to it in the Medical Affairs Plan, and to cooperate with the other
Party in carrying out the Medical Affairs Plan, in accordance with the
timetables therein. Each Party and its Affiliates shall conduct its Medical
Affairs Activities in good scientific manner and in compliance with applicable
Law and this Agreement. Notwithstanding anything to the contrary contained
herein, a Party or its Affiliates shall not be obligated to undertake or
continue any Medical Affairs Activity if such Party (or any of its Affiliates)
reasonably determines that performance of such activity would violate applicable
Law or other obligation of such Party to a Governmental Authority.

4.2.7. Medical Affairs Costs. Each Party shall be responsible for fifty percent
(50%) of all Out-of-Pocket Costs and all Medical Affairs FTE Costs incurred by
the Parties to conduct Medical Affairs Activities in accordance with the Medical
Affairs Plan and the Medical Affairs Budget (the “Medical Affairs Costs”).
Medical Affairs Costs shall initially be borne by the Party incurring the cost
or expense, and thereafter shall be subject to reimbursement as provided in this
Section 4.2.7. Each Party shall report to the JMAC, within [**] days after the
end of each Calendar Quarter, an estimate of the Medical Affairs Costs incurred
by such Party during such Calendar Quarter, with a final report submitted to the
JMAC for such costs within [**] days after the end of each Calendar Quarter.
Such report shall specify in reasonable detail all amounts incurred during such
Calendar Quarter (broken down by activity).

 

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4.2.8. Reimbursement of Medical Affairs Costs. Following receipt of each Party’s
report of its Medical Affairs Costs, the JMAC will determine the payment
necessary from one Party to the other, and the Party that has paid less than its
share of Medical Affairs Costs during such Calendar Quarter shall make a
reconciling payment to the other Party within [**] days after receipt of an
invoice from the JMAC to achieve the appropriate allocation of Medical Affairs
Costs provided in Medical Affairs Plan and Medical Affairs Budget in accordance
with reconciliation procedures to be established by the JMAC (the “Medical
Affairs Reconciliation Procedures”). The Medical Affairs Reconciliation
Procedures will provide the ability to comply with financial reporting
requirements of each Party under applicable Laws. Notwithstanding the foregoing,
any Medical Affairs Costs in excess of the amounts allocated for the activities
of a Party in the applicable Calendar Year in the Medical Affairs Budget shall
be borne solely by the Party that incurs such excess costs; provided, however,
that Medical Affairs Costs in excess of the budgeted amount shall be included in
the calculation of Medical Affairs Costs, (a) to the extent such excess costs do
not exceed by more than [**] percent ([**]%) the total Medical Affairs Costs
allocated to be incurred by such Party and its Affiliates in the applicable
Calendar Year in accordance with the applicable Medical Affairs Budget for such
Calendar Year, or (b) if the JMAC approves such excess (either before or after
they are incurred), which approval shall not be unreasonably withheld to the
extent that such costs in excess of the Medical Affairs Budget were not within
the reasonable control of the Party (or Affiliate) incurring such expense. If
either Party desires to conduct additional Medical Affairs Activities under the
Medical Affairs Budget, it shall discuss the matter at the JMAC. If either Party
does not reasonably object to the conduct of such activities but the JMAC is not
willing to agree upon an updated Medical Affairs Budget to reflect additional
funds to conduct such activities, the requesting Party shall be free to conduct
such Medical Affairs Activities and incur additional Medical Affairs Costs in
connection therewith; provided, however, that unless such excess costs are
required to be reimbursed under Section 4.2.3, such costs shall be the incurring
Party’s sole expense.

4.3. Development Efforts; Manner of Performance; Reports.

4.3.1. Development Efforts. Each Party shall use Diligent Efforts to execute and
to perform, or cause to be performed, the activities assigned to it in the GDP,
and to cooperate with the other Party in carrying out the GDP, in accordance
with the timetables therein. Each Party and its Affiliates shall conduct its
Development activities in good scientific manner and in compliance with
applicable Law and this Agreement. Notwithstanding anything to the contrary
contained herein, a Party or its Affiliates shall not be obligated to undertake
or continue any Development activities with respect to the Licensed Compounds or
Products if such Party (or any of its Affiliates) reasonably determines that
performance of such Development activity would violate applicable Law or
infringe or misappropriate Third Party intellectual property.

4.3.2. Day-to-Day Responsibility. Each Party shall be responsible for day-to-day
implementation of the Development activities for which it (or any of its
Affiliates) is assigned responsibility under this Agreement or the GDP and shall
keep the other Party reasonably informed as to the progress of such activities.
In addition, notwithstanding anything to the contrary in this Agreement:

 

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(a) The Party who is the regulatory sponsor of any Clinical Study of a Licensed
Compound or Product or the Party conducting such Clinical Study may terminate or
suspend such Clinical Study, without the approval or consent of a Committee or
the other Party, if (A) a Regulatory Authority, institutional review board or
safety data review board for such Clinical Study has required or recommended
such termination or suspension or (B) such Party believes in good faith that
such termination or suspension is warranted because of observed safety risks to
the study subjects or patients. In either case, the Party making the decision
shall promptly notify the other Party of such termination or suspension, and
shall use Diligent Efforts to notify and consult with such other Party prior to
taking such action; and

(b) If the Party who is not conducting and who is not the regulatory sponsor of
any Clinical Study of a Licensed Compound or Product (the “Non-Sponsor) believes
in good faith that termination or suspension of such Clinical Study is warranted
because of safety risks to the study subjects or patients, then the Non-Sponsor
shall so notify the other Party (the “Sponsor”), and the JDC shall discuss the
Non-Sponsor’s concerns in good faith to determine whether to terminate, suspend,
modify or continue such Clinical Study. If the JDC and, if applicable following
escalation, JSC and Executive Officers are unable to reach agreement with
respect to whether to terminate, suspend, modify or continue such Clinical
Study, and the Sponsor wants to continue such Clinical Study, the Sponsor shall
have the right to do so, provided that the Sponsor shall indemnify and hold
harmless the Non-Sponsor from and against any Losses to the extent resulting
from any Product Liability Action alleged to be caused by the safety risks
raised by the Non-Sponsor and in fact occurring during the conduct of such
Clinical Study from and after the date that the Non-Sponsor first notified the
Sponsor in accordance with this Section 4.3.2(b) of such safety risks and
proposed terminating or suspending such Clinical Study.

4.3.3. Development Reports. At each meeting of the JDC, each Party will report
on the Development activities (including Clinical Studies and regulatory
activities) such Party and its Affiliates have performed or caused to be
performed with respect to Licensed Compounds and Products in the Field since the
last meeting of the JDC and the clinical and other results arising from such
activities with at least the level of information described in the following
sentence, evaluate the work performed in relation to the goals of the GDP and
provide such other information as may be reasonably requested by the JDC with
respect to such Development activities. If a Party fails to adequately provide
such report at a meeting of the JDC, the other Party may request, and such Party
will provide to such other Party, a written progress report that includes
information regarding subject or patient enrollment, site initiation, progress
on protocol writing, meeting requests and briefing documents, in the case of
clinical or regulatory activities, and in other cases such information as is
reasonably necessary to convey a reasonably comprehensive understanding of the
status of the applicable Development activity or, with respect to any such
request by Infinity, to comply with its reporting obligations under the Infinity
Third Party Agreements.

4.3.4. Notice of Investigation or Inquiry. If any Regulatory Authority
(a) contacts a Party or its Affiliate with respect to the alleged improper
Development, Manufacture or Commercialization of any Licensed Compound or
Product in the Territory, (b) conducts, or gives notice of its intent to
conduct, an inspection at a Party’s or its Affiliate’s facilities used in the
Development or Manufacturing of Licensed Compound or Products, or (c) takes, or
gives notice of its intent to take, any other regulatory action with respect to
any activity of a Party or its Affiliate that could reasonably be expected to
adversely affect any Development, Manufacture or Commercialization activities
with respect to a Licensed Compound or Product in the Territory, then such Party
shall promptly notify the other Party of such contact, inspection or notice.

 

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4.4. Regulatory Submissions and Regulatory Approvals.

4.4.1. Ownership of Regulatory Approvals. Subject to Sections 4.4.2 and 4.4.3,
Infinity or its relevant Affiliates shall file and hold all Regulatory Filings,
and shall use Diligent Efforts to seek and attempt to obtain and maintain
Marketing Authorizations, for the Products in the Field in the US Territory in
accordance with the GDP other than for any Combination Product that includes the
AbbVie Combination Compound or the use of the AbbVie Combination Compound with a
Licensed Compound or Product. Subject to Section 4.4.3, AbbVie or its relevant
Affiliates shall have the sole right to file and hold all Regulatory Filings in
the Ex-US Territory, and shall use Diligent Efforts to seek and attempt to
obtain and maintain Marketing Authorizations for the Products in the Field in
the Ex-US Territory in accordance with the GDP. AbbVie or its relevant
Affiliates shall have the right to file and hold all Regulatory Filings in the
Field in the Territory for any Combination Product that includes the AbbVie
Combination Compound or the use of the AbbVie Combination Compound with a
Licensed Compound or Product, and shall, to [**], use Diligent Efforts to seek
and attempt to obtain and maintain Marketing Authorizations for such Combination
Products in the US Territory and the Ex-US Territory in accordance with the GDP.
For clarity, the rights and obligations set forth in this Section 4.4.1shall be
in accordance with the GDP. The Parties shall file and hold all Regulatory
Filings in eCTD format and in a manner sufficient to permit each Party to comply
with its Third Party agreements, including Infinity’s obligations under each of
the Infinity Third Party Agreements.

4.4.2. [**] Regulatory Filings. In each of the US, EU and Japan, prior to the
first Regulatory Approval in each jurisdiction therein, [**] of a Product
conducted under the GDP, the applicable Regulatory Owner will determine [**].
If, in any such regulatory jurisdiction, the Regulatory Owner [**]. In such
event, if required by applicable Law for the filing of the Regulatory Approval
Application, [**]. Thereafter, the Party [**] with respect to such Regulatory
Approval Application under this 4.4.2 shall use Diligent Efforts to seek and
attempt to obtain and maintain Marketing Authorizations for the Products in the
Field in each such regulatory jurisdiction.

4.4.3. Regulatory Cooperation.

(a) Subject to applicable Law and Section 4.4.2 and this Section 4.4.3, the
Party responsible for filing and holding Regulatory Filings and obtaining and
maintaining Marketing Authorizations in a particular territory in accordance
with Section 4.4.1 (“Regulatory Owner”) shall oversee, monitor and manage all
regulatory interactions, communications and filings with, and submissions to,
Regulatory Authorities with respect to the Products in such territory. The
Regulatory Owner shall have final decision making authority regarding all
regulatory activities, including the labeling strategy and the content of
submissions within such territory, subject to the Global Branding Strategy and
the terms and conditions of this Agreement, and the right of the non-owning
Party to review and comment on such strategies and submissions. The Regulatory
Owner shall ensure that the manner in which a Product shall be presented and
described to the medical community in any Promotional Materials and the
placement of names and logos of the Parties therein, as permitted by applicable
Law, is consistent with the labeling for such Product approved by the applicable
Regulatory Authority. To the extent required under applicable Law, the
Regulatory Owner shall submit any Promotional Materials for use in the territory
for which it is responsible, which have been approved pursuant to this
Agreement, to the applicable Regulatory Authorities.

 

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(b) Subject to applicable Law, each Party shall have the right to attend, in an
observer role only, all material meetings, conferences and discussions by the
other Party or its Affiliate with Regulatory Authorities pertaining to the
Development or Regulatory Approval of the Products in the Field. Each Party
shall provide the other Party with reasonable advance notice of all such
interactions and will provide advance copies of all related documents and other
relevant information relating to such interactions. Each Party shall provide the
JDC and the JSC with advance drafts of any material documents or other material
correspondence pertaining to Regulatory Approvals of the Products, including any
proposed labeling, that such Party plans to submit to any Regulatory Authority.
The JDC may provide comments regarding such documents and other correspondence
prior to their submission, which comments the submitting Party shall consider in
good faith. Each Party shall provide the other Party with copies of all material
submissions it makes to, and all material correspondence it receives from, a
Regulatory Authority pertaining to a Regulatory Approval of a Product. Notices,
copies of submissions and correspondence, and other materials to be given in
advance as provided in this Section 4.43(b) shall be provided at least [**]
Business Days in advance unless circumstances necessitate a shorter time period,
and in any event not less than a reasonable time in advance under the
circumstances.

(c) Each Party shall make every reasonable effort to notify the other Party
promptly upon its determination that any event, incident or circumstance has
occurred that may result in the need for a Recall, market withdrawal or stock
recovery of a Product (but in no event later than [**] hours and in all cases
prior to the execution of such Recall, market withdrawal or stock recovery). For
all Recalls, market withdrawals and stock recoveries that are taken, the
Regulatory Owner shall be responsible for execution, and the other Party shall
reasonably cooperate in all such efforts.

4.4.4. Rights of Reference and Access to Data. Each Party and its Affiliates
shall have the right to cross-reference the other Party’s or its Affiliate’s
drug master file (“DMF”), if any, and any other Regulatory Filings or
information supporting Pricing and Reimbursement Approval anywhere in the world,
in each case, to the extent such files, filings and support relate to Licensed
Compounds or Products in the Field, and to access such Regulatory Filings and
any Data and other Know-How therein and use such Data and Know-How in connection
with the performance of its obligations and exercise of its rights under this
Agreement, including inclusion of such Data and other Know-How in its own
Regulatory Filings and filings for Pricing and Reimbursement Approvals for
Products in accordance with this Agreement. Each Party hereby grants to the
other Party a “Right of Reference,” as that term is defined in 21 C.F.R.
§314.3(b) in the United States, or an equivalent exclusive right of
access/reference in any other country or region of the Territory, to any Data
included in a Regulatory Filing or filing for Pricing and Reimbursement Approval
for a Product for use by the other Party to Develop and Commercialize the
Products in the Field pursuant to this Agreement. Each Party or such Affiliate
shall provide a signed statement to this effect, if requested by the other
Party, in accordance with 21 C.F.R. §314.50(g)(3) or the equivalent as required
in any country or region of the Territory, or otherwise provide appropriate
notification of such right of the other Party to the applicable Regulatory
Authority.

4.5. Pharmacovigilance. Within [**] days after the Effective Date, the Parties
shall establish a process for the exchange of safety data in a mutually agreed
format, including but not limited to, postmarketing spontaneous reports and
adverse event reports received by the Party or its Affiliates in order to
monitor the safety of the Product and to meet reporting requirements with any
applicable regulatory authority.

 

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4.6. Costs of Joint Development.

4.6.1. Cost. Development Costs incurred after the Execution Date by a Party in
accordance with the GDP and Development Budget shall be borne by Infinity;
provided, however, that (a) if the aggregate Development Costs incurred by the
Parties, excluding any Combination Study Costs, exceed the Development
Threshold, then any Development Costs in excess of the Development Threshold
shall be borne fifty percent (50%) by AbbVie and fifty percent (50%) by Infinity
(the “Shared Overage Costs”), (b) any Development Costs incurred by the Parties
in connection with a Combination Clinical Study (the “Combination Study Costs,”
and together with the Shared Overage Costs, the “Shared Development Costs”)
shall be borne fifty percent (50%) by AbbVie and fifty percent (50%) by Infinity
and (c) [**]. In addition, except as provided in Section 4.1.6(d), Product
supply and combination and comparator drug costs incurred by a Party prior to
the Execution Date for Clinical Trials included in the initial GDP and
contemplated by the initial Development Budget as described in Schedule 4.6.1
will be included as Development Costs hereunder. For the avoidance of
double-counting, the Parties acknowledge and agree that Development Costs shall
not be included in Allowable Expenses for purposes of calculating Net Profit or
Loss in accordance with the Financial Exhibit (and, likewise, that any amounts
included in Allowable Expenses shall not be included in Development Costs).

4.6.2. Development Costs Reports. Development Costs shall initially be borne by
the Party incurring the cost or expense, and thereafter shall be subject to
reimbursement as provided in Section 4.6.3. Each Party shall report to the JDC
within [**] days after the end of each Calendar Quarter, the estimated
Development Costs incurred by such Party during such Calendar Quarter, with a
final report submitted to the JDC within [**] days after the end of each
Calendar Quarter. Such report shall specify, in reasonable detail, all amounts
included in such Development Costs incurred during such Calendar Quarter (broken
down by activity). Within [**] days of receipt of each Party’s report, the JDC
shall seek to resolve any questions related to such accounting statements, and
shall have the right to request reasonable additional information related to a
Party’s and its Affiliates’ Development Costs during such Calendar Quarter in
order to confirm that such Party’s spending is in conformance with the approved
Development Budget in accordance with the reconciliation procedures to be
established by the JDC (the “Development Reconciliation Procedures”). The
Development Reconciliation Procedures shall provide for the JDC to develop a
written summary report setting forth in reasonable detail the calculation of any
net amount owed by Infinity to AbbVie or by AbbVie to Infinity, as the case may
be, as necessary to accomplish the sharing of Development Costs set forth in
Section 4.6.1 and Section 4.6.3, and to prepare such report promptly following
the procedures described in this Section 4.6.2 and in a reasonable time in
advance of payment.

4.6.3. Reimbursement of Development Costs.

(a) Following completion of the Development Reconciliation Procedures for each
Calendar Quarter, the Party conducting a Combination Clinical Study shall
invoice the other Party for its share of Combination Study Costs incurred in the
preceding Calendar Quarter, and the other Party shall pay each such invoice
within [**] days after receipt

 

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thereof; provided, however, that the other Party shall only be obligated to
reimburse the conducting Party for Combination Study Costs in excess of the
Development Budget (x) to the extent such excess Combination Study Costs do not
exceed by more than [**] percent ([**]%) of the total Combination Study Costs in
the Development Budget for such Calendar Year; provided, that, for purposes of
determining whether such excess Combination Study Costs exceed the total
Combination Study Costs in the Development Budget for such Calendar Year by more
than [**] percent ([**]%) (i) amounts included in the Development Budget for
Combination Study Costs that are not used in a given Calendar Year shall be
carried into subsequent Calendar Years, and (ii) if any Combination Clinical
Study commences earlier or enrolls faster than anticipated in the GDP, the
associated Combination Clinical Study Costs will be added to the Development
Budget for the Calendar Year in which such costs are incurred, (y) if the JDC
approves such excess Combination Study Costs (either before or after they are
incurred), which approval shall not be unreasonably withheld to the extent the
Combination Study Costs in excess of the Development Budget were not within the
reasonable control of the conducting Party, or (z) pursuant to the provisions of
Section 4.1.1. In the event of any dispute regarding the reconciliation payments
due from one Party to the other, the Parties shall work together in good faith
to resolve such dispute as expeditiously as possible, but the foregoing shall
not prevent either Party from pursuing resolution of such dispute through the
JDC and, failing agreement at the JDC, escalation to the JSC in accordance with
Section 2.9.1. If the JSC is unable to resolve such dispute, then either Party
shall have the right to refer such matter for resolution to Arbitration in
accordance with ARTICLE 13.

(b) (i) before the Development Threshold has been reached, Infinity shall pay
AbbVie an amount of cash sufficient to reimburse AbbVie for any previously
agreed-upon (if not explicitly allocated to AbbVie in the GDP) Infinity-Borne
Development Costs incurred by AbbVie in each Calendar Quarter and (ii) after the
Development Threshold has been reached, the Party (with its Affiliates) that
incurs more than its share of the total actual Shared Development Costs shall be
paid by the other Party an amount of cash sufficient to reconcile to fifty
percent (50%) of actual Shared Development Costs in each Calendar Quarter, in
each case within [**] days after receipt of invoice; provided, that the Parties
shall also undertake an annual true-up within [**] days after the fourth
Calendar Quarter of each Calendar Year. Notwithstanding the foregoing, on a
Calendar Year basis, any Shared Development Costs or Infinity-Borne Development
Costs in excess of the amounts allocated to such Party for such Calendar Year in
the Development Budget shall be borne solely by the Party that incurs such
excess Development Costs; provided, however, that Development Costs in excess of
the Development Budget shall be included in the calculation of Infinity-Borne
Development Costs or Shared Development Costs, as applicable, (x) to the extent
such excess Development Costs incurred by a Party do not exceed by more than
[**] percent ([**]%) the total Infinity-Borne Development Costs or Shared
Development Costs, as applicable, on a Party-by-Party basis, allocated to be
incurred by such Party and its Affiliates in the applicable Calendar Year in
accordance with the applicable Development Budget for such Calendar Year;
provided, however, that, for purposes of determining whether such excess
Development Costs exceed the total Infinity-Borne Development Costs or Shared
Development Costs, as applicable, for such Calendar Year by more than [**]
percent ([**]%), (i) that amounts included in the Development Budget for
Infinity-Borne Development Costs or Shared Development Costs, as applicable,
that are not used in a given Calendar Year shall be carried into subsequent
Calendar Years for purposes of determining whether such threshold has been
exceeded, and (ii) if any Clinical Study in the GDP other than a Combination
Clinical Study commences earlier or enrolls faster than anticipated in the

 

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GDP, the associated Development Costs will be added to the Development Budget
for the Calendar Year in which such costs are incurred, (y) if the JDC approves
such excess Development Costs (either before or after they are incurred), which
approval shall not be unreasonably withheld to the extent the Development Costs
in excess of the Development Budget were not within the reasonable control of
the Party (or Affiliate) incurring such expense, or (z) pursuant to the
provisions of Section 4.1.1. Notwithstanding the foregoing, all Infinity-Borne
Development Costs will be counted toward the Development Threshold.

4.7. Development Records. Each Party shall maintain complete and accurate
records (in the form of technical notebooks or electronic files where
appropriate) of all work conducted by it under the GDP and all information
resulting from such work. Such records, including any electronic files where
such information may also be contained, shall fully and properly reflect all
work done and results achieved in the performance of the GDP in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes. Such records shall be maintained in appropriate conditions to ensure
their accessibility and protection until the date that is [**] years after the
expiration or termination of this Agreement in its entirety (unless applicable
Law requires longer retention of any given record, in which case such record(s)
shall be retained for so long as required by applicable Law).

ARTICLE 5.

COMMERCIALIZATION

5.1. Commercialization Efforts.

5.1.1. Oversight. The JCC shall oversee the Commercialization of Products by the
Parties in the Field in the Territory.

5.1.2. Responsibilities of the Parties; Costs.

(a) In the US Territory. Each Party shall be responsible for conducting efforts
to Commercialize Products in the Field in the US, in accordance with this
ARTICLE 5 and the US Commercialization Plan. The Parties shall share costs and
expenses incurred in connection with the Commercialization of Licensed Compounds
and Products in the US Territory as described in the Financial Exhibit.

(b) In the Ex-US Territory. AbbVie shall be solely responsible for
Commercializing Products in the Field in the Ex-US Territory in accordance with
this ARTICLE 5 and the Ex-US Commercialization Plans. Except as expressly set
forth in this Agreement, AbbVie shall be responsible for all costs and expenses
it incurs in connection with the Commercialization of all Licensed Compounds and
Products in the Ex-US Territory.

5.1.3. Activities and Participation.

(a) In the US Territory. Each Party shall use Diligent Efforts to execute and to
perform, or cause to be performed, the activities assigned to it under the US
Commercialization Plan with respect to a Product after obtaining Regulatory
Approval for such Product in the US. The JCC may propose amendments to the US
Commercialization Plan subject to JSC approval; provided that, in the event of a
conflict between the provisions in a US Commercialization Plan authorized
hereunder and this Agreement, the provisions of this Agreement shall supersede
any US Commercialization Plan.

 

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(b) In the Ex-US Territory. AbbVie shall use Diligent Efforts to Commercialize
Products in the Field in the Ex-US Territory after obtaining Regulatory Approval
therefor with respect to the applicable country in accordance with the Ex-US
Commercialization Plan. The Parties acknowledge and agree that, among other
relevant factors, (i) following Generic Entry in a country during the Royalty
Term, the level of efforts required by AbbVie to satisfy the foregoing
requirement may be different from such level of efforts prior to Generic Entry
and (ii) the foregoing requirement does not require AbbVie to Commercialize a
Product in any particular country if it would be inconsistent with Diligent
Efforts to do so.

(c) No Violation. Notwithstanding anything to the contrary contained herein, a
Party and its Affiliates shall not be obligated to undertake or continue any
Commercialization activities with respect to the Licensed Compounds or Products
if such Party (or such Affiliate) reasonably determines that performance of such
Commercialization activity would violate applicable Law or infringe or
misappropriate any Third Party intellectual property.

5.2. Manner of Performance.

5.2.1. Day-to-Day Responsibility. Each Party shall be responsible for day-to-day
implementation of the Commercialization activities assigned to it under this
Agreement and the Commercialization Plans and shall keep the other Party
reasonably informed as to the progress of such activities.

5.2.2. Commercialization Reports.

(a) In the US Territory. At each meeting of the JCC, each Party will report on
the Commercialization activities (including activities conducted to generate
Commercialization Support Data) such Party and its Affiliates and Sublicensees
have performed or caused to be performed with respect to Licensed Compounds and
Products in the Field in the US since the last meeting of the JCC, evaluate the
work performed in relation to the goals of the US Commercialization Plan and
provide such other information as may be required by the US Commercialization
Plan or reasonably requested by the other Party to permit such other Party to
obtain, in reasonable detail, an understanding of the status and performance of
such Commercialization activities or to comply with its reporting obligations
under the Third Party agreements, including the Infinity Third Party Agreements.
The JCC shall review each Party’s and its Affiliates’ and Sublicensees’
performance of Commercialization Activities during each Calendar Quarter and
shall provide a report of such progress to the JSC at each quarterly meeting of
the JSC.

(b) In the Ex-US Territory. AbbVie shall provide informational updates to the
JCC of its planned and completed activities for Commercialization of Products in
the Ex-US Territory under the Ex-US Commercialization Plan at each meeting of
the JCC and shall respond in a timely fashion to any reasonable requests of
Infinity with respect to such activities and results to permit Infinity to
obtain, in reasonable detail, an understanding of the status and performance of
such Commercialization activities and to comply with its reporting obligations
under the Infinity Third Party Agreements.

 

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5.3. Commercialization Plans.

5.3.1. Commercialization Plan Preparation. AbbVie, consistent with its Diligent
Efforts obligations, shall determine the countries in the Ex-US Territory that
will be included in the Ex-US Commercialization Plan to be submitted to the JCC
for review and to the JSC for approval. In addition, AbbVie may prepare
country-specific commercialization plans for countries in the Ex-US Territory as
it deems appropriate, and shall make such plans available to Infinity. The
initial Commercialization Plans for the US and Ex-US Territory shall be prepared
by the applicable Party, reviewed by the JCC and approved by the JSC in
accordance with this Section 5.3.1 no later than [**]. The Parties shall jointly
prepare the initial draft US Commercialization Plan, and shall thereafter
alternate responsibility for preparing each draft or annual update to the US
Commercialization Plan (starting with Infinity). AbbVie shall prepare the Ex-US
Commercialization Plan and each country-specific commercialization plan for the
Ex-US Territory, which shall be consistent with the Global Branding Strategy and
include an annual forecast of Gross and Net Sales in the Ex-US Territory.
Commercialization Plans developed by either Party shall be reviewed by the JCC
and presented to the JSC for review and approval; provided, that the
country-specific commercialization plans will be shared with the JCC shall not
be subject to such JSC approval. The responsible Party shall update each
Commercialization Plan annually as provided in Section 5.3.3. The activities set
forth in each Commercialization Plan shall at all times be designed to be in
compliance with all applicable Laws and to be conducted in accordance with
professional and ethical standards customary in the pharmaceutical industry.
Each Commercialization Plan shall be prepared in good faith and shall include a
mutually agreed upon, rolling [**] Calendar Year plan for Commercializing the
Products in the applicable country, countries or region.

5.3.2. US Commercialization Budget. The US Commercialization Budget shall set
forth the budgeted amounts for costs with respect to activities allocated to the
Parties under such US Commercialization Plan [**] thereafter, and shall include
for both Parties a budget for applicable Commercialization FTE Costs and
Out-of-Pocket Costs for such period, broken down by Calendar Quarter for the
then-current Calendar Year. The US Commercialization Budget shall also include a
breakout of costs by functional area or category as determined by the JCC with
input and support from the Finance Working Group. Concurrently with the annual
update of the US Commercialization Plan in accordance with Section 5.3.1, the
JCC will prepare, and the JSC will review and approve an updated US
Commercialization Budget for the US Commercialization Plan. The US
Commercialization Budget shall be binding unless and until amended in accordance
with Section 5.3.1.

5.3.3. Amendments and Updates. Unless otherwise approved by the JSC, the
Commercialization activities (and, in the case of the US Territory, the US
Commercialization Budget) for the [**] Calendar Year of a Commercialization Plan
shall become the Commercialization activities and US Commercialization Budget
for the [**] Calendar Year in such subsequent Commercialization Plan unless the
Parties otherwise agree; provided, however, that the Commercialization
activities and the US Commercialization Budget shall be broken down by Calendar
Quarter with respect to the first Calendar Year in each Commercialization Plan.
The JCC

 

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shall meet no later than [**] of each Calendar Year to approve updates to each
Commercialization Plan and shall submit all such updates to the JSC for review
and approval, such that JSC preliminary approval would occur no later than [**]
of the Calendar Year preceding such Commercialization Plan. Upon the JSC’s
preliminary approval, such updates shall be submitted to each Party for its
internal budgeting process with a target for final approval by the JSC no later
than [**] of such Calendar Year, at which time such Commercialization Plan shall
be amended accordingly. The JCC shall also reasonably consider for approval any
proposed updates and amendments to a Commercialization Plan presented by either
Party. The JSC shall review such proposed amendments presented the JCC and may
approve such proposed amendments or any other proposed amendments that the JSC
may consider from time to time in its discretion and, upon such approval by the
JSC, the Commercialization Plan shall be amended accordingly. Amendments and
updates to a Commercialization Plan, including the US Commercialization Budget,
shall not be effective without the approval of the JSC or the Executive Officers
or the relevant Party pursuant to Section 2.9. If the JSC does not approve an
updated Commercialization Plan, including the US Commercialization Budget, prior
to the start of the next Calendar Year, either Party may initiate procedures to
resolve the issue pursuant to Section 2.9, and the then-current
Commercialization Plan, together with the budgeted amounts set forth in the US
Commercialization Budget, shall continue to apply with respect to the relevant
Products until the Commercialization Plan is agreed by the JSC or the Executive
Officers or the relevant Party pursuant to Section 2.9.

5.4. Global Branding Strategy. Each Party shall implement and adhere to the
Global Branding Strategy developed by the JCC and approved by the JSC in its
Commercialization of Products in the Territory unless an exception is approved
by the JSC or otherwise agreed to by the Parties in writing.

5.5. Commercialization Responsibilities for the US Territory. The Parties shall
have responsibility for Commercialization Activities as described below, and the
US Commercialization Plan will reflect such allocation of responsibilities
unless otherwise mutually agreed by the Parties. The Parties will conduct such
activities under the oversight of the JCC, and in each case consistent with the
Global Branding Strategy.

5.5.1. Sales Representative Training. The Parties shall jointly conduct training
of Sales Representatives with respect to the Product, and shall jointly prepare
all related training materials, and each Party shall be solely responsible for
training its Sales Representatives on such Party’s compliance policies and such
Party’s corporate matters.

5.5.2. Advertising and Public Relations. Infinity shall be responsible for
contracting with advertising agencies and Product public relations agencies to
support Commercialization of the Product in the US Territory.

5.5.3. Distribution and Patient Services. Infinity shall be responsible for
distribution and patient services for the Product in the US Territory, including
contracting with applicable service providers.

5.5.4. Advertising and Promotional Materials for Products. The Regulatory Owner
shall develop Promotional Materials for review and approval by the JCC relating
to the Products for use in the US by both Parties and their Affiliates that are
consistent with the Global Branding

 

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Strategy and comply with the US Commercialization Plan, applicable Laws and
Marketing Authorizations. Copies of all Promotional Materials used by the
Parties and their Affiliates with respect to Products in the US will be archived
by AbbVie or Infinity, as applicable, in accordance with applicable Laws.
Notwithstanding the foregoing, a Party shall not be obligated to use any
Promotional Materials that are not consistent with, and not approved in
accordance with, such Party’s internal policies.

5.5.5. Booking Sales in the US Territory. Infinity and its Affiliates shall have
the sole right to invoice, to sell and to book all sales of Products in the US
Territory, and shall be responsible for warehousing and distributing Products in
the US Territory, and the allocation of responsibilities and activities under
the US Commercialization Plan shall be made in a manner that permits Infinity to
book all sales of Products in the US Territory in accordance with the applicable
Accounting Standards. If AbbVie receives any order for a Product in the US
Territory, AbbVie shall promptly refer such order to Infinity. If AbbVie
receives any order for a Product in the Ex-US Territory from any purchaser and
AbbVie knows or has reason to believe that such purchaser intends to sell, offer
to sell or distribute such Product in the US Territory, AbbVie shall promptly
notify Infinity of such situation and the Parties, through the JSC, will discuss
the appropriate resolution. Notwithstanding anything in this Agreement to the
contrary, however, with respect to any Product which is a Combination Product
comprising both the Licensed Compound and the Abbvie Combination Compound,
unless otherwise agreed by the Parties in writing: (i) all Development of such
Combination Product would be mutually agreed upon, and conducted pursuant to the
GDP and under the direction of the JDC, and final decision making as to any
disputes related thereto would be governed by Section 2.9.3(a) and not 2.9.3(g);
and (ii) the strategic and tactical components of the Commercialization in the
US Territory for such a Combination Product shall be reviewed and determined by
the Parties, including, without limitation, the pricing, branding and
positioning, promotion, managed care contracting, distribution and patient
services, and which Party is the most appropriate Party to book sales of any
such Combination Product in the US Territory, it being understood, however, that
(x) nothing in this Agreement shall be deemed to have granted to Infinity any
right to sell or book sales of the Abbvie Combination Compound or any such
Combination Product, and (y) any such Commercialization decisions shall be
dependent upon and conform to any and all consents and approvals as are required
to be obtained under the Abbvie Third Party Agreements, and (z) Abbvie’s final
decision making rights pursuant to Section 2.9.3(g) with respect to all matters
relating to the Abbvie Combination Compound shall not govern such
determinations, which shall be required to be mutual decisions of the Parties.

5.5.6. Pricing. All decisions with respect to Product list price, targeted net
pricing, sales-weighted average discounts and rebates, pricing strategy
(including, without limitation, the approach to pricing with different types of
accounts and plans, including types of discounts and rebates), and modifications
to any of the foregoing, in the US Territory will be made by the JCC.

5.5.7. Other Commercial Functions. The Parties shall share responsibility for
all Commercialization activities other than those specifically set forth in
Sections 5.5.1 through 5.5.5 for the US Territory under the oversight of the JCC
and JSC, in accordance with the applicable Commercialization Plan, including
managed care and reimbursement, including negotiating and obtaining pricing or
reimbursement approval for the Product and negotiating managed care arrangements
in accordance with a strategy formulated by the JCC; monitoring performance of

 

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Sales Representatives; HECOR; commercial advisory boards; and market research,
forecasting and competitive intelligence.

5.6. Commercialization in the Ex-US Territory. AbbVie and its Affiliates shall
have the sole right to invoice, to sell and to book all sales of Products in the
Ex-US Territory, and to establish all terms of sale (including pricing and
discounts, provided that AbbVie shall not bundle Products with any other
products of AbbVie or its Affiliates without the mutual consent of the Parties),
and shall be responsible for warehousing and distributing Products in the Ex-US
Territory, and the allocation of responsibilities and activities under the
applicable Commercialization Plan shall be made in a manner that permits AbbVie
to book all sales of Products in the Ex-US Territory in accordance with the
applicable Accounting Standards. If Infinity receives any order for a Product in
the Ex-US Territory, Infinity shall promptly refer such order to AbbVie. If
Infinity receives any orders for a Product in the US Territory from any
purchaser and Infinity knows or has reason to believe that such purchaser
intends to sell, offer to sell or distribute such Product in the Ex-US
Territory, Infinity shall promptly notify AbbVie of such situation and the
Parties, through the JSC, will discuss the appropriate resolution.

5.7. Sales Representatives.

5.7.1. Each sales person used by a Party or its Affiliate to perform in-person
presentations of the Products to health care professionals or to perform Sales
Calls (each, a “Sales Representative”), pursuant to this Agreement shall be
employed by such Party or one of its Affiliates on a full-time basis (or engaged
by such Party or one of its Affiliates as an independent contractor in his/her
individual capacity), or be part of subcontracted sales force engaged in
accordance with Section 3.6.

5.7.2. Infinity and AbbVie shall each use Diligent Efforts to cause its and its
Affiliates’ Sales Representatives to comply with applicable Laws and industry
guidelines related to the performance of its obligations hereunder.

5.7.3. Each Party shall, and shall cause its Affiliates to, maintain records of
its Sales Representatives’ activities in accordance with such Party’s standard
record keeping procedures. The JCC will define procedures to exchange such data
quarterly or more frequently, and to ensure that such data shall be provided at
the Product, physician and Sales Representative level, including dates and
detail position.

5.8. Co-Promotion in the United States. Infinity and AbbVie will each be
obligated to Co-Promote Products in the U.S., on a Product-by-Product basis, by
each providing fifty percent (50%) of the Sales Representative FTEs with respect
to such Product in the US Territory in accordance with the terms to be
determined by the JCC in connection with the preparation and approval of the US
Commercialization Plan.

 

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ARTICLE 6.

MANUFACTURE AND SUPPLY

6.1. Manufacture.

6.1.1. Manufacturing Responsibility. Infinity shall be responsible for the
Manufacturing of the Licensed Compounds and Products for the Parties’ activities
under this Agreement, until such time as the Parties transition such
responsibility to AbbVie. No later than [**], the Manufacturing Working Group
shall prepare a transition plan which shall describe the activities and timeline
to transition manufacturing responsibility to AbbVie, including the
establishment of a second source for Licensed Compounds and Products, with the
objectives of completing the transfer of responsibility as promptly as possible,
while ensuring continuity of supply and adherence to the timelines of the GDP,
the Commercialization Plans and in accordance with applicable Law. Until such
time as AbbVie assumes responsibility for the Manufacturing of the Licensed
Compounds and Products, Infinity shall use Diligent Efforts to supply the
Parties’ requirements of Products for Development and Commercialization
activities pursuant to this Agreement and the GDP, and, in each case, pursuant
to the applicable Supply Agreement. The Party responsible for supplying a
Product (whether in drug substance, drug product or finished product form) to
the other Party shall supply such Product under the terms of a supply agreement
and a related quality agreement (such supply agreements and quality agreements,
collectively, the “Supply Agreements”), containing terms consistent with this
Agreement and typical for such agreements; provided, that in the event of an
inconsistency between this Agreement and any such Supply Agreements, such Supply
Agreement shall control solely with respect to quality-related and
supply-related matters. The Manufacturing Working Group shall determine the
timing for entering into the Supply Agreements. Infinity shall deliver to AbbVie
a reasonable quantity of initial supply of the Licensed Compound and Product for
use in Combination Clinical Studies ([**]), within a reasonable period of time
[**], or upon a determination by the Parties to conduct Clinical Studies [**] in
accordance with this Agreement. Each Party hereby represents and warrants to the
other Party that all Products supplied by such Party hereunder shall be
manufactured in accordance with GMP and the applicable global Product
specifications. Infinity will not engage any additional Third Party as a
secondary source of active pharmaceutical ingredient, drug product and primary
and secondary packaging manufacturing supplier for the purposes of establishing
a second supply chain without the approval of the Manufacturing Working Group.

6.1.2. Supply Price. The Supply Price of a Product supplied for Clinical Studies
under the GDP shall be treated as Development Costs and borne by the Parties in
accordance with Section 4.6 with respect to the Calendar Year in which such
Products are provided for use in such Clinical Studies. The Supply Price of a
Product supplied for Commercialization in (a) the United States shall be taken
into account in determining Net Profit or Loss as, and to the extent, provided
in the Financial Exhibit and (b) the Ex-US Territory shall be borne by AbbVie
and paid to Infinity under the applicable Supply Agreement, to the extent
Infinity remains responsible for Manufacturing activities. In all such cases,
the Supply Price shall be the Manufacturing cost for such Product, which (a) to
the extent such Product is Manufactured by a Party or its Affiliates, shall
approximate a reasonable definition of cost of goods sold for such Product with
no markup, assuming full utilization of Manufacturing capacity, and (b) to the
extent such Product is Manufactured by a Third Party in an arms-length
transaction, the Out-of-Pocket Costs paid to such Third Party for the
Manufacture of such Product.

6.1.3. Global Quality Agreement. Without limiting Section 6.1.1 with respect to
Supply Agreement-specific quality agreements, within [**] days following the
Effective Date, the Parties will negotiate in good faith, through the
Manufacturing Working Group, and execute a global quality agreement (the
“Quality Agreement”); provided, that in the event of an inconsistency between
this Agreement and such Quality Agreement, such Quality Agreement shall control
solely with respect to quality-related matters.

 

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6.1.4. Product Manufacture for Non-Oncology Indications. Infinity may
Manufacture the Licensed Compounds and Products for Development in Non-Oncology
Indications at all times during the Term. Once AbbVie assumes responsibility for
the Manufacturing of the Licensed Compounds and Products, Infinity shall have
the right to Manufacture directly or indirectly or purchase Licensed Compounds
and Products for Development in Non-Oncology Indications from AbbVie at the
Supply Price, subject to activities hereunder having priority over such
Development as described in the preceding sentence.

6.2. Manufacturing Working Group. The Manufacturing Working Group shall have
responsibility for monitoring and facilitating the overall progress of
Manufacturing activities under this Agreement with respect to Products in the
Field, including oversight of the various budgets and activities. In particular,
the Manufacturing Working Group shall:

6.2.1. develop the transition plan to transfer to AbbVie any Know-How related to
the Manufacture of Products and to transition the Manufacture of Products to
AbbVie in accordance with Section 6.1.1;

6.2.2. establish standards applicable to the Parties’ performance of
Manufacturing activities in accordance with the GDP, each Commercialization Plan
and this Agreement, and review each Parties’ performance against such standards;

6.2.3. meet at least quarterly for technical reviews to ensure timely exchange
of CMC Development plan technical progress, communication and technical
consultations;

6.2.4. share planning and budgeting information with the JDC and JCC and
coordinate with the JDC and JCC in preparing comprehensive planning and
budgeting proposals with respect to the Manufacturing activities for the
Development and Commercialization of Products in the Field; and

6.2.5. perform such other functions as are assigned to it in this Agreement or
as are appropriate to further the purposes of this Agreement as agreed in
writing by the Parties.

ARTICLE 7.

FINANCIAL PROVISIONS

7.1. Upfront and Milestone Payments. The provisions of Schedule 7 shall apply.

7.2. Net Profit or Loss.

7.2.1. Net Profit or Loss. Each Party shall bear (and be entitled to) fifty
percent (50%) of Net Profit or Loss in the United States. The JCC with input and
support from the Finance Working Group shall review quarterly reports of actual
results submitted by the Parties and review and discuss potential discrepancies,
reasonable forecasting, and other finance and accounting matters, in accordance
with the Financial Exhibit and Section 7.2.2 below, as applicable, to determine
the reimbursement due, if any, to a Party for each such Calendar Quarter, and
shall

 

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establish procedures with respect to the reconciliation of Net Profit or Loss in
the United States (the “Profit Reconciliation Procedures,” and together with the
Development Reconciliation Procedures and the Medical Affairs Reconciliation
Procedures, the “Reconciliation Procedures”).

7.2.2. Quarterly Reconciliation and Payments. Except to the extent otherwise
agreed by the Parties, the Profit Reconciliation Procedures shall provide that:

(a) Within [**] days after the end of each Calendar Quarter, each Party shall
submit to the JCC a report with regard to the estimated Net Sales and Allowable
Expenses incurred by each Party for the Product during such Calendar Quarter in
the US Territory in a manner sufficient to enable the other Party to comply with
its financial reporting requirements. A final report of such Net Sales and
Allowable Expenses shall be submitted to the JCC within [**] days after the end
of each Calendar Quarter. Such report shall specify in reasonable detail all
Deductions allowed in the calculation of such Net Sales and all expenses
included in Allowable Expenses. Following receipt of such report, each Party
shall reasonably cooperate to provide additional information as necessary to
permit calculation and reconciliation of Net Profit or Loss in the United States
for the applicable Calendar Quarter by the JCC, and to confirm that, to the
extent applicable, the Allowable Expenses are in conformance with the US
Commercialization Budget. If reasonably requested by the JCC, supporting
documentation shall be promptly provided.

(b) The Profit Reconciliation Procedures shall require the JCC with input and
support from the Finance Working Group to develop a written report setting forth
in reasonable detail the calculation of Net Profit or Loss in the United States
for the applicable Calendar Quarter, amounts owed by one Party to the other as
necessary to accomplish the sharing of Net Profit or Loss in the United States
for the applicable Calendar Quarter in accordance with Section 7.2.1, and to
prepare such report promptly following delivery of the reports from the Parties
as described above in this Section 7.2.2 and in a reasonable time in advance of
applicable payments. Payments to reconcile Net Profit or Loss in the United
States shall be paid within [**] days of receipt of such Report by a Party.

(c) Each Party shall (i) keep the other informed as to Gross Sales and Net Sales
on a regular, ongoing basis, with respect to Gross Sales and Net Sales levels in
the United States, as applicable to such Party, (ii) provide for quarterly
reporting of Gross Sales and Net Sales totals in the United States for the
applicable Calendar Quarter and (iii) keep the other informed as to forecast Net
Profit or Loss in the United States in accordance with the next sentence of this
Section 7.2.2(c). Together with such quarterly reporting of Gross Sales and Net
Sales, each Party will provide an updated forecast of Net Profit or Loss in the
United States for the current Calendar Quarter that such Party may then have
available, which forecasts shall be prepared in accordance with such Party’s
internal policies and procedures.

7.3. Royalties.

7.3.1. Royalty Rates. As further consideration for the rights granted to AbbVie
under this Agreement, on a country-by-country basis, during the applicable
Royalty Term, AbbVie shall pay to Infinity non-refundable, non-creditable
royalties on Net Sales of Products in the Ex-US

 

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Territory, as calculated by multiplying the applicable royalty rates below by
the corresponding amount of incremental Net Sales in the Ex-US Territory of all
Products in each Calendar Year:

 

Annual Net Sales of Products in the Ex-US Territory    Royalty Rate

For that portion of aggregate annual Net Sales less than US$[**]

   23.5%

For that portion of aggregate annual Net Sales greater than or equal to US$[**]
and less than US$[**]

   [**]%

For that portion of aggregate annual Net Sales greater than or equal to US$[**]
and less than US$[**]

   [**]%

For that portion of aggregate annual Net Sales greater than or equal to US$[**]

   30.5%

7.3.2. Royalty Term. Royalties shall be due under this Section 7.3 with respect
to a Product and country in the Ex-US Territory during the period commencing on
the First Sale of such Product and ending on the date on which AbbVie ceases
selling such Product in such country (such period, the “Royalty Term”).

7.3.3. Royalty Reduction.

(a) In any country in the Ex-US Territory where all Valid Claims of the Infinity
Patent Rights, AbbVie Patent Rights and [**] have ceased to exist that Cover the
use, formulation, preparation or manufacture of a particular Product during the
Royalty Term for such Product in such country, AbbVie shall owe royalties under
this Section 7.3 on Net Sales of such Product in such country at rates that are
[**] percent ([**]%) of the rates otherwise payable under Section 7.3.1. If in a
particular Calendar Quarter there are Net Sales of a particular Product in one
or more countries in the Ex-US Territory in which there is at least one such
Valid Claim and there are also Net Sales of such Product in one or more
countries in the Ex-US Territory in which there is no such Valid Claim, then the
royalties shall be calculated by determining the percentage of Net Sales in the
Ex-US Territory in such Calendar Quarter that are in each such type of country
and applying that percentage to each royalty tier to determine which portion of
the applicable amount should bear royalties at rates set forth in Section 7.3.1
and which should bear royalties at rates set forth in this Section 7.3.3(a).

(b) In the event of Generic Entry in any country in the Ex-US Territory, if the
Net Sales in such country of such Product in any Calendar Quarter following the
Calendar Quarter in which such Generic Entry occurred are [**], then AbbVie
shall owe royalties under this Section 7.3 on Net Sales of such Product in such
country during such Calendar Quarter at rates that are [**] percent ([**]%) of
the rates otherwise payable under Section 7.3.1. If in a particular Calendar
Quarter there are Net Sales of a particular Product in one or more countries in
the Ex-US Territory in which there has been a Generic Entry and there are also
Net Sales of such Product in one or more countries in the Ex-US Territory in
which there has not been a Generic Entry, then the royalties shall be calculated
by determining the percentage of Net Sales in the Ex-US Territory in such
Calendar Quarter that are in each such type of country and applying that
percentage to each royalty tier to determine which portion of the applicable
amount should bear royalties at rates set forth in Section 7.3.1 and which
should bear royalties at rates set forth in this Section 7.3.3(b). For clarity,
the royalty reduction in this Section 7.3.3(b) will no longer apply in any
country where a Generic Product is no longer sold in such country.

 

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(c) If, during the Royalty Term, Infinity’s royalty obligations under the MICL
Agreement and Purdue Agreement terminate or are reduced, then Infinity shall
promptly so notify AbbVie and, with respect to Net Sales occurring after the
date of such reduction or termination, each of the royalty rates set forth in
Section 7.3.1 shall be reduced on a point-for-point basis by the amount of
reduction or termination of the royalty obligations under the MICL Agreement and
Purdue Agreement. Within [**] days of the conclusion of each Calendar Year,
Infinity shall provide AbbVie with a reasonably detailed report showing all
Infinity Third Party Agreement Payments for the preceding Calendar Year.

(d) AbbVie shall be entitled to deduct from the royalties payable to Infinity
under this Section 7.3 [**] percent ([**]%) of any Blocking Third Party
Intellectual Property Costs paid by AbbVie and [**]; provided, however, that in
no event shall the royalties that would otherwise be payable to Infinity, as
reduced by Sections 7.3.3(a), 7.3.3(b) and 7.3.3(c) be reduced by more than [**]
percent ([**]%) in any given Calendar Quarter as a result of any deduction under
this Section 7.3.3(d); and provided further, that AbbVie shall be entitled to
carry forward to subsequent Calendar Quarters any amounts with respect to which
AbbVie would have been entitled to make a deduction pursuant to this
Section 7.3.3(d) but is unable to take such deduction pursuant to the first
proviso in this Section.

(e) For clarity, reductions shall first be applied under Section 7.3.3(c), and
following any such reductions, further reductions may be applied, as applicable,
under Sections 7.3.3(a) or 7.3.3(b) and Section 7.3.3(d), provided, that
reductions may be taken under either Section 7.3.3(a) or 7.3.3(b) (or neither),
but not both, and, provided further that in no event will the cumulative effect
of Section 7.3.3(a), (b) and (d) reduce the royalties that would otherwise be
payable to Infinity under Section 7.3.1 by more than [**] percent ([**]%) from
the rate in effect following the reduction, if any, under Section 7.3.3(c).

(f) In addition to any other deductions permitted under this Section 7.3.3, the
royalties due under this Section 7.3 shall be net of any amounts to be deducted
and recouped as provided in Sections 3.5.1(e), 10.6.5(c) and Section 12.2.1(b).

7.3.4. Royalty Payments and Reports. Within [**] days after the end of each
Calendar Quarter, AbbVie shall provide to Infinity a statement of the estimated
amount of Gross Sales and Net Sales (and the calculations thereof) of Products
in each country of the Ex-US Territory during such Calendar Quarter (including
such amounts expressed in local currency and as converted to Dollars),
identifying the date of First Sale in the relevant country. Within [**] days
after the end of each Calendar Quarter, AbbVie shall provide a final statement
of such Gross Sales and Net Sales, (and the calculations thereof) of Products in
each country of the Ex-US Territory during such Calendar Quarter (including such
amounts expressed in local currency and as converted to Dollars) an including a
calculation of the amount of royalty payment due on such Net Sales for such
Calendar Quarter and any deductions with respect thereto. AbbVie shall pay to
Infinity the royalty amounts due under this Section 7.3 with respect to each
Calendar Quarter within [**] days after the end of such Calendar Quarter.
Without limiting the generality of the foregoing, AbbVie shall require its
Affiliates and Sublicensees to account for its Gross Sales and Net Sales and

 

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to provide such reports with respect thereto as if such sales were made by
AbbVie. At Infinity’s reasonable request, AbbVie shall use good faith efforts to
provide Infinity with additional information necessary for Infinity to comply
with its royalty reporting obligations under any Infinity Third Party
Agreements.

7.4. Reconciliation of Costs Incurred in or for the Ex-US Territory.

7.4.1. Costs Borne Solely by AbbVie. On a Calendar Quarterly basis, Infinity
shall determine all amounts payable by AbbVie to Infinity to reimburse the
applicable portion of costs incurred by Infinity in such Calendar Quarter under
Sections 3.5.1(d) and 3.5.2 (Infinity Third Party Agreement Payments) in
connection with the Development, Manufacture or Commercialization of Products in
the Ex-US Territory in accordance with the GDP or the Ex-US Commercialization
Plans and the terms of this Agreement (such amounts, the “Reimbursable
Amounts”). Infinity shall provide a reasonably detailed invoice to AbbVie for
such amounts after the end of each Calendar Quarter in which such amounts were
incurred. AbbVie shall pay each such invoice within [**] days after its receipt
thereof.

7.4.2. Costs and Recoveries [**] all Out-of Pocket Costs incurred under
Section 8.7.2(c)(iii) (Product Trademark Costs) relating to the registration and
maintenance of Product Trademarks in the Ex-US Territory (the “[**]”), under
Section 8.7.5 relating to Product Trademark enforcement in the Ex-US Territory,
and under Section 8.7.3 for Actions in the Ex-US Territory. Recoveries under
Sections 8.3.7 and 8.7.5 for the Ex-US Territory [**]. Within [**] days after
the end of each Calendar Quarter, [**] shall submit to the JCC an estimated
report, in such reasonable detail and format as is established by the JCC with
input and support from the Finance Working Group, of all [**] incurred or
accrued during such Calendar Quarter, with a final report submitted to the JCC
within [**] days after the end of each Calendar Quarter. Following receipt of
such report, the Finance Working Group shall determine [**]. The reconciliation
for the fourth Calendar Quarter in any Calendar Year shall include [**]. Within
[**] days after the Finance Working Group’s determination, the applicable Party
shall pay the other Party the amount due.

7.5. Financial Audits.

7.5.1. Each Party and its Affiliates shall keep complete and accurate records in
accordance with its Accounting Standards of the items underlying the Milestone
Payments, Development Costs, Allowable Expenses, Gross Sales, Net Sales, Net
Profit or Loss, Reimbursable Amounts, [**], Infinity Third Party Agreement
Payments, and the other elements thereof required to prepare the reports or
calculate payments required under this Agreement and the Reconciliation
Procedures, and any other payments under this Agreement. Each Party will have
the right annually at its own expense to have an independent, certified public
accountant, selected by such Party and reasonably acceptable to the other Party,
review any such records of the other Party and its Affiliates in the location(s)
where such records are maintained by the other Party or its Affiliates upon
reasonable prior written notice, during regular business hours and under
obligations of confidentiality, for the sole purpose of verifying the basis and
accuracy of payments made under this Agreement and the Reconciliation
Procedures, and any other payments due under this Agreement, within the prior
[**] Calendar Year period. The records for any Calendar Year may be audited no
more than once.

 

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7.5.2. Upon the expiration of [**] years following the end of any Calendar Year,
the calculation of amounts payable with respect to such Calendar Year shall be
binding and conclusive upon Infinity and AbbVie, and the Parties shall be
released from any liability or accountability with respect to payments for such
Calendar Year.

7.5.3. The report prepared by the independent certified public accounting firm,
a copy of which shall be sent or otherwise provided to each Party by such
independent public accountant at the same time, shall contain the conclusions of
such accounting firm regarding the audit and will specify that the amounts paid
pursuant thereto were correct or, if incorrect, the amount of any underpayment
or overpayment, and the specific details regarding any discrepancies. No other
information shall be provided to the auditing Party without the prior consent of
the audited Party unless disclosure is required by law, regulation or judicial
order, and if so determined by the auditing Party, it shall, if permitted, give
the audited Party prior notice thereof reasonably sufficient for the audited
Party to seek a protective order against or limiting such disclosure. If such
report shows any underpayment, the Party owing a payment (“Owing Party”) shall
remit to the Party that is owed (“Owed Party”), within [**] days after receipt
of such report, (a) the amount of such underpayment, together with interest
calculated in the manner provided in Section 7.9, and (b) if such underpayment
exceeds [**] percent ([**]%) of the total amount owed for the period then being
audited, the reasonable Out-of-Pocket Costs incurred in conducting such review.
Any overpayments shall be refunded to the Owed Party by the Owing Party within
[**] days of receipt of the audit report. The Parties mutually agree that all
information subject to review under this Section is Confidential Information of
the audited Party (subject to Sections 1.122(a)-(d)) and that the Party
receiving such information shall retain and cause the accountant to retain all
such information in confidence in accordance with ARTICLE 9.

7.6. Tax Matters.

7.6.1. Each Party shall be solely responsible for the payment of all taxes
imposed on its share of income arising directly or indirectly from the
collaborative efforts of the Parties under this Agreement, except as expressly
set forth in this Section 7.6.

7.6.2. A Party shall withhold and deduct from all payments made (or to be made)
pursuant to this Agreement by such Party (the “Withholding Party”), any tax
required to be withheld and deducted from such payments under applicable Law and
in accordance with this Section 7.6. Any amounts so withheld and deducted shall
be remitted by the Withholding Party on a timely basis to the appropriate
Governmental Authority for the account of the other Party and the Withholding
Party will provide the other Party reasonable evidence of the remittance within
[**] days thereof. To the extent that amounts are so withheld by the Withholding
Party and duly paid over to the appropriate Governmental Authority, such
withheld amounts shall be treated for all purposes of this Agreement as having
been paid to the other Party, in respect of which such deduction and withholding
was made. Each Party shall furnish to the Withholding Party such forms,
certificates and documentation as may be necessary or appropriate, and that are
legally required, to obtain any reduction of, credit for, or exemption from the
withholding of any tax.

7.6.3. If AbbVie (or AbbVie’s Affiliates or successors) is required to make a
milestone payment attributable to an Enrollment Event or a Milestone Event that
occurred in an Ex-US Territory, or that is treated by the appropriate
Governmental Authority as occurring in an Ex-US Territory, or a royalty payment
that is based on Net Sales of Products in an Ex-US Territory, and Withholding
Tax is deducted from such payment when made to Infinity as a result of an AbbVie
Withholding Tax Action, then notwithstanding Section 7.6.2:

 

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(a) if such Withholding Tax is the result of a Required Withholding Tax Action,
then AbbVie (or AbbVie’s Affiliates, or successors) shall make a payment to
Infinity equal to fifty percent (50%) of the excess of the Required Incremental
Withholding Tax over the Required Withholding Tax Benefit, if any, for the
taxable year to which the Required Incremental Withholding Tax relates; and

(b) if such Withholding Tax is the result of an AbbVie Withholding Tax Action
that is not a Required Withholding Tax Action, then AbbVie (or AbbVie’s
Affiliates or successors) shall make a payment to Infinity equal to one-hundred
percent (100%) of the excess of the Incremental Withholding Tax over the
Withholding Tax Benefit, if any, for the taxable year to which the Incremental
Withholding Tax relates.

Infinity shall compute the payments due under clause (a) and (b) for each year
during the Term no later than [**] days after filing its U.S. federal income tax
return for such taxable year. Any such payment referenced in clause (a) or
(b) shall be made to Infinity within [**] days of the date on which Infinity
provides (i) written notice that a payment is due and (ii) its computation of
the amount of the payment. Any Withholding Tax as a result of payments for
Incremental Withholding Tax and Required Incremental Withholding Tax under this
Section 7.6.3, along with any other Withholding Tax, shall be timely remitted to
the proper Governmental Authority for the account of Infinity in accordance with
applicable Law and AbbVie shall provide Infinity reasonable evidence of the
remittance within [**] days of such remittance. The Parties will cooperate with
respect to all documentation required by any taxing authority or reasonably
requested by either Party to secure a reduction in the rate of applicable
withholding taxes and similar obligations on payments made under this Agreement.

7.6.4. If for any taxable year of Infinity, an Infinity Affiliate or successor,
the Required Withholding Tax Benefit exceeds the Required Incremental
Withholding Tax for such taxable year, or the Withholding Tax Benefit exceeds
the Incremental Withholding Tax for such taxable year, then Infinity shall make
a payment or payments to AbbVie as follows:

(a) Infinity (or Infinity’s Affiliates or successors) shall make a payment to
AbbVie equal to fifty percent (50%) of the excess of the Required Withholding
Tax Benefit over the Required Incremental Withholding Tax, if any, for such
taxable year or; and

(b) Infinity (or Infinity’s Affiliates or successors) shall make a payment to
AbbVie equal to one hundred percent (100%) of the excess of the Withholding Tax
Benefit over the Incremental Withholding Tax, if any, for such taxable year.

Infinity hereby agrees to inform AbbVie in the event that a payment is owed
under this Section 7.6.4 within [**] days of the date on which Infinity, the
Infinity Affiliate or successor files its United States Federal tax return for
such taxable year. Infinity further agrees to make the requisite payments to
AbbVie within [**] days of the filing of such return. Upon request, Infinity
shall provide AbbVie with a reconciliation of the computation of the amount of
the payments under this Section to the disclosures in the tax footnote to its
audited financial statements.

 

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7.6.5. Section 7.6.3 shall apply only if the recipient of the payment
thereunder, whether Infinity, an Infinity Affiliate or successor, is a tax
resident of the United States and the beneficial owner of the payment.

7.6.6. In the event that a taxing authority retroactively determines that a
payment made by a Withholding Party to the other Party pursuant to this
Agreement should have been subject to withholding or to additional withholding
of taxes, and the Withholding Party remits such taxes to the taxing authority,
the Withholding Party will have the right (a) to offset such amount, including
any interest and penalties that may be imposed thereon (except to the extent any
such interest or penalties result from the gross negligence of the Withholding
Party), against future payment obligations of the Withholding Party under this
Agreement, (b) to invoice the other Party for such amount (which shall be
payable by the other Party within [**] days of its receipt of such invoice) or
(c) to pursue reimbursement by any other available remedy.

7.6.7. All amounts payable under this Agreement are exclusive of value added tax
or any similar consumption tax or duties (“Indirect Taxes”). If any Indirect
Taxes are chargeable in respect of any payments, the paying Party shall pay such
Indirect Taxes at the applicable rate in respect of such payments following
receipt, where applicable, of an Indirect Taxes invoice in the appropriate form
issued by the receiving Party in respect of those payments. The Parties shall
issue invoices for all amounts payable under this Agreement consistent with
requirements for Indirect Taxes and irrespective of whether the sums may be
netted for settlement purposes. If the Indirect Taxes originally paid or
otherwise borne by the paying Party are in whole or in part subsequently
determined not to have been chargeable, all necessary steps will be taken by the
receiving Party to receive a refund of these undue Indirect Taxes from the
applicable governmental authority or other fiscal authority and any amount of
undue Indirect Taxes repaid by such authority to the receiving Party will be
transferred to the paying Party within [**] days of receipt.

7.7. Currency Exchange.

7.7.1. Currency of Payments. All payments under this Agreement shall be paid in
U.S. Dollars, by wire transfer to an account designated by the receiving Party
(which account the receiving Party may update from time to time in writing).

7.7.2. Currency Conversion. Except with respect to the calculation of Net Sales,
for which the currency conversion shall be determined in accordance with the
definition of “Net Sales,” if any amounts that are relevant to the determination
of amounts to be paid under this Agreement or any calculations to be performed
under this Agreement are denoted in a currency other than U.S. Dollars, then
such amounts shall be converted to their U.S. Dollar equivalent as follows:

(a) With respect to amounts denoted in U.S. Dollars, all such amounts shall be
expressed in U.S. Dollars; and

 

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(b) With respect to amounts denoted in a currency other than U.S. Dollars, all
such amounts shall be expressed both in the currency in which the amount was
denoted and in the U.S. Dollar equivalent. The U.S. Dollar equivalent shall be
calculated using the relevant Party’s then-current standard procedures and
methodology, including its then-current standard exchange rate methodology for
the translation of foreign currency expenses into U.S. Dollars or, in the case
of Sublicensees, such similar methodology, consistently applied.

For clarity, the currency conversion provisions, and other relevant definitions
and provisions, of the relevant Infinity Third Party Agreement shall apply to
calculate the relevant Infinity Third Party Agreement Payments.

7.8. Blocked Payments. If, by reason of applicable Laws in any country, it
becomes impossible or illegal for a Party or its Affiliate or Sublicensee to
transfer, or have transferred on its behalf, payments to the other Party, the
owing Party shall promptly notify the owed Party of the conditions preventing
such transfer and such distribution fees or other payments shall be deposited in
local currency in the relevant country to the credit of the owed Party in a
recognized banking institution designated by the owed Party or, if none is
designated by the owed Party within a period of [**] days, in a recognized
banking institution selected by the owing Party or its Affiliate and identified
in a written notice given to the owed Party.

7.9. Late Payments. Interest shall be payable by a Party on any amounts payable
to the other Party under this Agreement which are not paid by the due date for
payment. All interest shall accrue and be calculated on a daily basis (both
before and after any judgment) at a rate per annum equal to [**] above the
then-current “prime rate” in effect published in The Wall Street Journal,
Eastern Edition (but in no event in excess of the maximum rate permissible under
applicable Law), for the period from the due date for payment until the date of
actual payment. The payment of such interest shall not limit the Party owed the
relevant payment from exercising any other rights it may have as a consequence
of the lateness of any payment. For clarity, the Party owing such interest shall
be solely responsible for paying such interest to the other Party and such
interest shall not be considered Development Costs or Net Profit or Loss or in
any other manner shared by the Parties.

ARTICLE 8.

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

8.1. Ownership of Inventions.

8.1.1. Sole Inventions. As between the Parties, each Party (or its Affiliate)
shall exclusively own all inventions conceived solely by the employees or agents
of such Party or its Affiliates in the course of such Party’s and its
Affiliates’ performance of Development, Manufacturing or Commercialization
activities under this Agreement (“Sole Inventions”). Sole Inventions conceived
solely by the employees and agents of AbbVie or its Affiliates are “AbbVie Sole
Inventions”. Sole Inventions conceived solely by the employees and agents of
Infinity or its Affiliates are “Infinity Sole Inventions”.

 

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8.1.2. Joint Inventions. The Parties or their Affiliates shall jointly own all
inventions conceived jointly by employees and agents of AbbVie or its
Affiliates, on the one hand, and employees and agents of Infinity or its
Affiliates, on the other hand, in the course of performing Development,
Manufacturing or Commercialization activities under this Agreement (“Joint
Inventions”), on the basis of each Party (or its Affiliate, as applicable)
having an undivided interest in the whole without a duty to account to the other
Party. To the extent not inconsistent with any terminal disclaimer, each Party
and its Affiliates shall have the right to sell or otherwise transfer its
interest in such Joint Invention, and related Joint Patent Rights, to its
Affiliates or Third Parties, in each case without the consent of the other
Party, so long as such sale or transfer is subject to the licenses granted
pursuant to this Agreement and is otherwise consistent with this Agreement.

8.1.3. [**]. As between the Parties, and notwithstanding any other provision of
this Agreement, [**] shall own all Know-How and Patent Rights first conceived or
first reduced to practice solely by the employees or agents of either Party or
its Affiliates or jointly by employees and agents of AbbVie or its Affiliates,
on the one hand, and employees and agents of Infinity or its Affiliates, on the
other hand in the course of [**] and, [**] shall, and hereby does, assign its
interest in or to any [**] will provide all further cooperation that [**]
reasonably requests to give effect to [**], including executing and delivery
further assignments, consents, releases and other commercially reasonable
documentations and providing (and causing its Affiliates, and its and its
Affiliates’ employees and agents to provide) good faith testimony by affidavit,
declaration, deposition, in person or other proper means and otherwise assisting
[**] in support of any effort to establish, perfect, defend or enforce its
rights in the [**] shall at all times retain rights in [**]. Notwithstanding the
foregoing, this Section 8.1.3 shall not apply in respect of any Know-How and
Patent Rights that are first conceived or first reduced to practice as a result
of activities undertaken prior to the Effective Date.

8.1.4. Inventorship. For purposes of determining whether an invention is an
AbbVie Sole Invention, an Infinity Sole Invention or a Joint Invention,
questions of inventorship shall be resolved in accordance with United States
patent Laws, whether or not such invention is patentable or patented.

8.1.5. Third Party Agreements.

(a) Infinity Third Party Agreements. The provisions of Sections 8.2 through 8.6
are subject to the terms of each applicable Infinity Third Party Agreement and
shall be interpreted in a manner that is consistent with the rights of the
relevant Third Party counterparty (and its licensors) under the relevant
Infinity Third Party Agreement.

(b) AbbVie Third Party Agreements. The provisions of Sections 8.2 through 8.6
are subject to the terms of each applicable AbbVie Third Party Agreement and
shall be interpreted in a manner that is consistent with the rights of the
relevant Third Party counterparty (and its licensors) under the relevant AbbVie
Third Party Agreement. [**].

8.1.6. Joint Patent Rights. For purposes of determining the rights and
obligations of the Parties under Sections 8.2 through 8.4, each Party’s interest
in Joint Patent Rights shall be considered only Joint Patent Rights, and not
Infinity Patent Rights or AbbVie Patent Rights.

8.1.7. Assignment Obligation. Each Party shall cause all employees of such Party
who perform activities for such Party under this Agreement to be under an
obligation to assign their

 

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rights in any inventions, whether or not patentable, resulting therefrom to such
Party. With respect to any activities subcontracted to a Person that is not an
employee, the Party retaining such subcontractor shall use commercially
reasonable efforts to include in the applicable subcontract an assignment to
such Party of all rights in inventions made by such subcontractor resulting from
such activities. If a Party is not able to include such assignment, then such
Party shall notify the IP Working Group, and the IP Working Group will determine
whether such Party may subcontract such activities on different invention
ownership terms. If the IP Working Group is unable to agree on such matter, the
matter will be referred to the JDC for resolution.

8.1.8. IP Working Group. The Parties’ shall coordinate their activities under
Sections 8.2 through 8.6 through the IP Working Group.

8.2. Prosecution and Maintenance of Patent Rights.

8.2.1. [**] Prosecution.

(a) [**] shall have the sole right, subject to Section 8.2.1(b), using in-house
or outside legal counsel selected by [**] and mutually acceptable to each Party,
to prepare, file, prosecute and maintain the [**] on a global basis. As of the
Effective Date, [**] are mutually acceptable to the Parties. [**] shall, with
respect to [**], keep [**]reasonably informed of all steps with regard to and
the status of the preparation, filing, prosecution, and maintenance of such
patent rights, including by providing [**] with (i) copies of all correspondence
and material communications it sends to or receives from the US Patent and
Trademark Office (the “USPTO”), the European Patent Office (“EPO”) and
equivalent patent offices in foreign jurisdictions, relating to the [**] Rights,
(ii) a draft copy of all applications sufficiently in advance of filing to
permit reasonable review and comment by [**], and (iii) a copy of applications
as filed, together with notice of its filing date and serial number. Before [**]
submits any material filing, including a new patent application, or response to
such patent authorities with respect to the [**] with drafts of such filing or
response and provide [**] with a reasonable opportunity to review and comment on
such filing or response. [**] shall take into account and consider in good faith
[**] reasonable and timely requests and suggestions regarding the filing,
prosecution and maintenance of the [**] under this Section 8.2.1(a).

(b) If [**] elects not to continue to prosecute a patent application within the
[**], or elects not to maintain a patent within the [**] shall give [**] notice
thereof within a reasonable period (but not less than [**] days) prior to
allowing such patent applications or patents to lapse or become abandoned or
unenforceable. The IP Working Group shall discuss the Parties’ respective views,
and [**]; provided, however, that this Section 8.2.1(b) shall not apply if,
instead of prosecuting such patent application, [**] instead files a divisional,
continuation or continuation-in-part of such patent application, which
divisional, continuation or continuation-in-part covers the same or greater
scope for the relevant Product(s) as the [**] proposed to be abandoned.

(c) If a Third Party initiates a patent opposition, reexamination, or other pre-
or post-grant proceeding in the USPTO, EPO or foreign equivalent, asserting that
any [**] is invalid or otherwise unenforceable, other than in response to an
infringement Action bought pursuant to Section 8.3, [**] shall control the
response to such proceeding, but shall consult

 

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with [**] and shall take into account and consider in good faith [**] reasonable
and timely requests and suggestions. For clarity, the provisions of
Section 8.2.1(a) and 8.2.1(b) shall apply to any of these proceedings controlled
by [**] shall not settle any such proceeding without [**] consent, such consent
not to be unreasonably withheld. To the extent any amounts are paid in
settlement of such proceeding with respect to [**], the same shall be shared
equally by the Parties.

8.2.2. [**] Patent Rights Prosecution.

(a) [**] shall have the first right, using in-house or outside legal counsel
selected by [**] and mutually acceptable to each Party, to prepare, file,
prosecute and maintain the [**] shall, with respect to [**], keep [**]
reasonably informed of all steps with regard to and the status of the
preparation, filing, prosecution, and maintenance of such patent rights,
including by providing [**] with (i) copies of all correspondence and material
communications it sends to or it receives from the USPTO, the EPO and equivalent
patent offices in foreign jurisdictions, relating to the [**], (ii) a draft copy
of all applications sufficiently in advance of filing to permit reasonable
review and comment by [**], and (iii) a copy of applications as filed, together
with notice of its filing date and serial number. Before [**] submits any
material filing, including a new patent application, or response to such patent
authorities with respect to the [**] shall provide [**] with drafts of such
filing or response and provide [**] with a reasonable opportunity to review and
comment on such filing or response. [**] shall take into account and consider in
good faith [**] reasonable and timely requests and suggestions regarding the
filing, prosecution and maintenance of the [**] under this Section 8.2.2(a).

(b) If [**] elects not to continue to prosecute a patent application within the
[**], or elects not to maintain a patent within the [**] shall give [**] notice
thereof within a reasonable period (but not less than [**] days) prior to
allowing such patent applications or patents to lapse or become abandoned or
unenforceable. The IP Working Group shall discuss the Parties’ respective views,
and [**]; provided, however, that this Section 8.2.2(b) shall not apply if,
instead of prosecuting such patent application, [**] instead files a divisional,
continuation or continuation-in-part of such patent application, which
divisional, continuation or continuation-in-part covers the same or greater
scope for the relevant Product(s) as the [**] proposed to be abandoned.

(c) If a Third Party initiates a patent opposition, reexamination, or other pre-
or post-grant proceeding in the USPTO, EPO or foreign equivalent, asserting that
any [**] is invalid or otherwise unenforceable, other than in response to an
infringement Action bought pursuant to Section 8.3, [**] shall control the
response to such proceeding, but shall consult with [**] and shall take into
account and consider in good faith [**] reasonable and timely requests and
suggestions. For clarity, the provisions of Section 8.2.2(a) and (b) shall apply
to any of these proceedings controlled by [**] shall not settle any such
proceeding without [**] consent, such consent not to be unreasonably withheld.
To the extent any amounts are paid in settlement of such proceeding with respect
to an [**] by the Parties.

8.2.3. [**] Patent Rights. The Parties, through the IP Working Group, [**]
decide whether, and how, to file, prosecute and maintain the [**] (other than
the [**]) and shall [**] with respect thereto.

 

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8.2.4. Maintenance and Prosecution Costs. All reasonable Patent Costs incurred
by the Parties and their respective Affiliates with respect to [**], and the
[**] shall be considered “[**]” and shall be included in [**].

8.2.5. Cooperation. Each Party shall, and shall cause its Affiliates to,
reasonably cooperate, with the other with respect to the preparation, filing,
prosecution and maintenance of Infinity Patent Rights, Joint Product Patent
Rights and AbbVie Patent Rights pursuant to this Section 8.2.

8.3. Third Party Infringement.

8.3.1. Patent Enforcement Strategy. Promptly following the [**] of [**], the
Parties, through the IP Working Group, shall meet and discuss generally the
Parties’ enforcement strategy in both the US Territory and the Ex-US Territory
with respect to the Infinity Patent Rights, AbbVie Patent Rights or Joint Patent
Rights, which such strategy shall guide the Parties in their decision making
with respect to enforcement of such Patent Rights pursuant to this
Section 8.3.1, and [**]. In addition, upon receipt of notice by a Party under
8.3.2 of an actual or potential infringement by a Third Party of any Infinity
Patent Rights, AbbVie Patent Rights or Joint Patent Rights, the IP Working Group
will again convene with respect to the particular strategy to be undertaken with
respect thereto, in light of the general strategy previously agreed upon.

8.3.2. Notice. Each Party shall promptly notify the other of any apparent,
threatened or actual infringement by a Third Party of any Infinity Patent
Rights, AbbVie Patent Rights or Joint Patent Rights of which it becomes aware,
including receipt of any notice filed pursuant to 21 U.S.C.§355(b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV) or any notice under comparable US or foreign Law (a
“Paragraph IV Certification”), with respect to the Infinity Patent Rights,
AbbVie Patent Rights or Joint Patent Rights.

8.3.3. Enforcement of [**].

(a) [**] shall have the first right to institute any infringement Action under
any [**] where a Party reasonably determines that a Third Party is marketing or
plans to market an infringing product [**] that competes with a Product,
including such an infringement resulting from a Paragraph IV Certification. [**]
shall have the right to institute such Action in the name of [**], or in the
names of both of them.

(b) If [**] institutes an infringement Action in accordance with
Section 8.3.3(a), [**] shall have the right to review and comment upon material
strategic decisions relating to such Action, provided that [**] shall have the
final say with respect thereto. In addition, [**] shall, and shall cause its
Affiliates to, reasonably cooperate with [**] in its efforts to protect such
[**] and shall agree to join as a party in any such Action, if required to give
[**]. Further, [**] shall have a right, in [**] sole discretion, to join or
otherwise participate in such Action with legal counsel selected by [**] shall
notify and keep [**] apprised in writing of such Action and shall consider and
take into account [**] reasonable interests and requests regarding such Action.

(c) If [**] does not institute an infringement Action to protect the [**]
(i) [**] may institute such infringement Action. In such event, [**] shall have
the right, but not the obligation, to institute such Action in the name of [**]
or of [**], or in the names of both of them.

 

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If [**] institutes an infringement Action in accordance with this
Section 8.3.3(c), [**] shall, and shall cause its Affiliates to, reasonably
cooperate with [**] in its efforts to protect such [**] and shall agree to join
as a party in such Action, if required to give [**]. Further, [**] shall have a
right, in [**] sole discretion, to join or otherwise participate in such Action
with legal counsel selected by [**] shall notify and keep [**] apprised in
writing of such Action and shall consider and take into account [**] reasonable
interests and requests regarding such Action.

8.3.4. Enforcement of [**].

(a) [**] shall have the first right to institute any infringement Action under
only those [**] for the Product [**], where a Party reasonably determines that a
Third Party is marketing or plans to market an infringing product [**] that
competes with a Product, including such an infringement resulting from a
Paragraph IV Certification. [**] shall have the right to institute such Action
in the name of [**], or in the names of both of them.

(b) If [**] institutes an infringement Action in accordance with
Section 8.3.4(a), [**] shall have the right to review and comment upon material
strategic decisions relating to such Action, provided that [**] shall have the
final say with respect thereto. In addition, [**] shall, and shall cause its
Affiliates to, reasonably cooperate with [**] in its efforts to protect such
[**] and shall agree to join as a party in any such Action, if required to give
[**]. Further, [**] shall have a right, in [**] sole discretion, to join or
otherwise participate in such Action with legal counsel selected by [**] shall
notify and keep [**] apprised in writing of such Action and shall consider and
take into account [**] reasonable interests and requests regarding such Action.

(c) If [**] does not institute an infringement Action to protect such [**] from
such infringement in a [**] (i) [**] may institute such infringement Action. In
such event, [**] shall have the right, but not the obligation, to institute such
Action in the name of [**] or of [**], or in the names of both of them. If [**]
institutes an infringement Action in accordance with this Section 8.3.4(c), [**]
shall, and shall cause its Affiliates to, reasonably cooperate with [**] in its
efforts to protect such [**] and shall agree to join as a party in such Action,
if required to give [**]. Further, [**] shall have a right, in [**] sole
discretion, to join or otherwise participate in such Action with legal counsel
selected by [**] shall notify and keep [**] apprised in writing of such Action
and shall consider and take into account [**] reasonable interests and requests
regarding such Action.

8.3.5. Enforcement of [**].

(a) [**] shall have the first right to institute infringement Action under the
[**] where a Party reasonably determines that a Third Party is marketing or
plans to market an infringing product in any country in the Territory that
competes with a Product, including such an infringement resulting from a
Paragraph IV Certification. [**] shall have the right to institute such Action
in the name of [**] or of [**], or in the names of both of them.

(b) If [**] institutes an infringement Action in accordance with
Section 8.3.5(a), [**] shall have the right to review and comment upon material
strategic decisions relating to such Action, provided that [**] shall have the
final say with respect thereto. [**] shall, and shall cause its Affiliates to,
reasonably cooperate with [**] in its efforts to protect such [**] and shall

 

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agree to join as a party in such Action, if required to give [**]. Further, [**]
shall have a right, in [**] sole discretion, to join or otherwise participate in
such Action with legal counsel selected by [**] shall notify and keep [**]
apprised in writing of such Action and shall consider and take into account [**]
reasonable interests and requests regarding such Action.

(c) If [**] does not institute an infringement Action to protect the [**] from
such infringement [**] (i) [**] or (ii) [**] may institute such infringement
Action. In such event, [**] shall have the right, but not the obligation, to
institute such Action in the name of [**] or of [**], or in the names of both of
them. If [**] institutes an infringement Action in accordance with this
Section 8.3.5(c), [**] shall, and shall cause its Affiliates to, reasonably
cooperate with [**] in its efforts to protect such [**] and shall agree to join
as a party in such Action, if required to give [**]. Further, [**] shall have a
right, in [**] sole discretion, to join or otherwise participate in such Action
with legal counsel selected by [**] shall notify and keep [**] apprised in
writing of such Action and shall consider and take into account [**] reasonable
interests and requests regarding such Action.

8.3.6. Cooperation. In any infringement Action brought under the [**] pursuant
to Sections 8.3.3, 8.3.4 or 8.3.5, each Party shall, and shall cause its
Affiliates to, reasonably cooperate with each other, in good faith, relative to
the other Party’s efforts to protect the [**] in accordance with Sections 8.3.3,
8.3.4 or 8.3.5 and shall agree to be a party to such suit, if necessary.
Notwithstanding the above, [**] or [**] brought pursuant to Sections 8.3.3,
8.3.4 or 8.3.5 without the prior written consent of the other Party, which
consent shall not be unreasonably withheld. Furthermore, the Party initiating
any infringement Action pursuant to Sections 8.3.3, 8.3.4 or 8.3.5 shall provide
the other Party with reasonable prior notice and opportunity to review and
comment on, and shall consider in good faith all reasonable and timely comments
from such other Party on, any proposed arguments asserted or to be asserted in
litigation related to the enforcement or defense of any such Patent Rights
pursuant to Sections 8.3.3, 8.3.4 or 8.3.5.

8.3.7. Expenses and Recoveries. All reasonable Out-of-Pocket Costs incurred by
either Party pursuant to Sections 8.3.3, 8.3.4 or 8.3.5 in connection with
enforcement of Patent Rights shall be [**]. Any recovery obtained as a result of
any such Action, by settlement or otherwise, shall be [**].

8.3.8. Other Enforcement.

(a) The Parties shall jointly decide whether and how to enforce the Joint Patent
Rights [**]. If required under applicable Law in order for the initiating Party
to initiate or maintain a suit pursuant to this Section 8.3.8(a), the other
Party or its Affiliate shall join as a party to the suit and shall offer
reasonable assistance to the initiating Party in connection therewith. Unless
otherwise agreed by the Parties, [**].

(b) [**].

(c) [**].

8.3.9. Claimed Infringement.

 

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(a) Each of the Parties shall promptly notify the other if a Third Party brings
any Action alleging patent infringement by AbbVie or Infinity or any of their
respective Affiliates or Sublicensees with respect to the Development,
Manufacture or Commercialization of any Licensed Compound or Product (any such
Action, an “Infringement Claim”). In the case of any Infringement Claim, the
Parties shall promptly, and within [**] days after written notice from either
Party to the other thereof, discuss which Party shall control the response to
such Infringement Claim, and if the Parties do [**], the [**], subject to
ARTICLE 11, [**]. Upon the request of the Party controlling the response to the
Infringement Claim, the other Party shall reasonably cooperate with the
controlling Party in the reasonable defense of such Infringement Claim. The
other Party will have the right to consult with the controlling Party concerning
any Infringement Claim and to participate in and be represented by independent
counsel in any associated litigation. If the Infringement Claim is brought
against both Parties, then each Party shall have the right to defend against the
Infringement Claim.

(b) Subject to ARTICLE 11, with respect to any Infringement Claim for allegedly
infringing activities conducted in or for the US, each Party shall bear [**]
obtained by the Third Party asserting such Infringement Claim, by settlement or
otherwise; provided, that, the Party with respect to which such Infringement
Claim was brought had performed the allegedly infringing Development,
Manufacture or Commercialization of a Licensed Compound or Product in accordance
with this Agreement; in all other cases, the Party [**]. Subject to ARTICLE 11,
the Out-of-Pocket Costs in defending, and providing requested assistance in the
defense of, such Infringement Claim for allegedly infringing activities
conducted in or for the [**] shall be considered [**], unless the Party with
respect to which the Infringement Claim was brought [**] Development,
Manufacture or Commercialization of a [**], in which case [**].

8.4. Patent Term Extensions. [**] shall have the sole right to determine which
[**], if any, to extend pursuant to the U.S. Drug Price Competition and Patent
Term Restoration Act of 1984, the Supplementary Certificate of Protection of
Member States of the EU and other similar measures in any country in the
Territory, in order to protect any Product. [**] shall cooperate with [**]
requests in connection therewith and use reasonable efforts to help gain any
such patent term extension pursued at the direction of [**]. All Out-of-Pocket
Costs incurred by either Party pursuant to this Section 8.4 shall be considered
Shared Patent Prosecution Costs and included in the Development Costs.

8.5. Patent Marking. Each Party shall mark each Product made, used or sold under
this Agreement (or when the character of the product precludes marking, the
package containing any such Product) in accordance with all applicable Laws
relating to patent marking.

8.6. Orange Book Listings. [**] shall have the sole right to determine which
[**] to list in the Orange Book in the U.S. or other foreign equivalents and
shall, at its discretion, undertake, at its costs and expense, to file any
relevant information in order to ensure appropriate listing in the Orange Book
relating to the Product; provided that [**] shall consult with [**] and the IP
Working Group in making such determination, and [**] will cooperate with [**]
reasonable requests in connection therewith.

 

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8.7. Trademarks.

8.7.1. Retained Rights in Corporate Marks and Logos. Each Party and its
Affiliates shall retain all right, title and interest in and to its and their
respective corporate names and logos. Neither Party shall use the other Parties’
corporate names or logos without obtaining prior written consent of the other
Party.

8.7.2. Product Trademark.

(a) Selection. The JCC shall select a global Product Trademark for Products
throughout the world consistent with the Global Branding Strategy.

(b) Promotion. Each Product shall be promoted and sold, in accordance with the
provisions of this Agreement, in the Territory under the applicable Product
Trademarks unless such Product Trademark cannot be legally used (either for
regulatory or trademark law reasons), or the Parties agree that it is not
commercially viable to use such Product Trademark, to promote and sell the
Product in a country, in which case an alternative Product Trademark proposed by
the JCC, with respect to a Product, shall be used in such country.

(c) Ownership.

(i) Infinity (or its Affiliates, as appropriate) shall own and retain all rights
to Product Trademarks for Products worldwide, and all goodwill associated with
or attached thereto arising out of the use thereof by the Parties, their
Affiliates and Sublicensees shall inure to the benefit of Infinity. AbbVie, on
behalf of itself and its Affiliates, hereby assigns to Infinity or its relevant
Affiliate all right, title and interest in and to such Product Trademarks and
goodwill. AbbVie will not contest, oppose or challenge Infinity’s ownership of
such Product Trademarks.

(ii) Infinity shall own rights to any Internet domain names incorporating any
Product Trademark, or any variation or part of any Product Trademark, as its URL
address or any part of such address.

(iii) Infinity will use Diligent Efforts to register, maintain and enforce the
Product Trademarks during the Term. All costs of such registration, maintenance
and enforcement efforts (the “Product Trademark Costs”) shall be (A) Allowable
Expenses to the extent such costs relate to Product Trademarks in the US and
(B) shared equally by the Parties in accordance with Section 7.4.2 to the extent
such costs relate to Product Trademarks in the Ex-US Territory.

8.7.3. Co-Branding. Unless otherwise agreed to by the Parties, all Promotional
Materials relating to a Product in the Field shall display the applicable
Product Trademark(s) and no other product-specific trademarks or branding;
provided, however, that (a) to the extent permitted by Law and if reasonably
practicable, the Parties shall include the Intellikine name or logo (the
“Intellikine Mark”) on commercial packaging for such Product in the U.S. and a
disclosure that the Intellikine Mark is licensed from Intellikine; provided,
however, that any use of the Intellikine Mark shall be in compliance with
Intellikine’s then-current reasonable trademark guidelines provided to Infinity
and AbbVie; and (b) each Party shall, to the extent permitted by Law and unless
otherwise agreed to by the JCC, include the corporate names of both Parties on
packaging, labels, containers, advertisements and other materials related
thereto with respect to the Products.

 

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Intellikine or an Affiliate of Intellikine shall retain the ownership of the
entire right, title and interest in and to the Intellikine Mark, and all
goodwill associated with or attached to the Intellikine Mark arising out of the
use thereof by the Parties, their Affiliates and Sublicensees shall inure to the
benefit of Intellikine. Neither Party will contest, oppose or challenge
Intellikine’s ownership of the Intellikine Mark. Each Party agrees that it will
not at any time do any act or thing that will in any way impair Intellikine’s
ownership of or rights in and to the Intellikine Mark or any registration
thereof or that may depreciate the value of the Intellikine Mark or the
reputation of Intellikine.

8.7.4. Quality Control. AbbVie agrees that the quality of the Products, and the
Manufacture and Commercialization thereof, to the extent undertaken by AbbVie,
marketed under the Product Trademarks shall be consistent with the
specifications set forth in the relevant Supply Agreement and the standards of
quality customary in the pharmaceuticals industry. Each Party shall, and shall
cause its respective Affiliates to, comply with then-current trademark style and
usage standards approved by Infinity, in accordance with this Agreement, in
connection with the use of the Product Trademarks or approved by the applicable
Party in connection with the use of its name or logo; provided, however, that
the applicable Party shall approve any such standards with respect to the
trademark style or use of its corporate names or logos. AbbVie shall, and shall
cause its Affiliates to, at its own expense, submit a sample of each proposed
use of a Product Trademark to the JCC for approval, which approval shall not be
unreasonably withheld or delayed. Each Party shall, and shall cause its
Affiliates to, at its own expense, submit a sample of each proposed use of the
other Party’s name or logo to the JCC for approval, which approval shall not be
unreasonably withheld or delayed. If the Party owning, as applicable, the
relevant Product Trademark, name or logo reasonably objects to a proposed usage
of a Product Trademark, name or logo, it shall give written notice of such
objection to the other Party within [**] days of receipt by the JCC of such
sample, specifying the way in which such usage of its Product Trademark, name or
logo fails to meet the quality, style or usage standards for such Product or
Product Trademark, name or logo set forth in the first two sentences of this
Section 8.7.4. If the non-owning Party or its Affiliate wishes to use such
sample, it must remedy the failure and submit further samples to the JCC for
approval.

8.7.5. Enforcement. If either Party becomes aware of any infringement of any
Product Trademark by a Third Party, such Party shall promptly notify the other
Party. With respect to any such enforcement in the US Territory, the Parties
shall promptly meet to determine how to enforce the Product Trademark in the US
and the strategy for such enforcement, provided that [**] shall have the first
right to bring and control such enforcement action in the [**] shall have the
first right to bring and control such enforcement action for infringements of
the Product Trademarks in the [**], but consistent with the agreed strategy for
the [**] if there is a similar [**] case, and [**] shall keep [**] reasonably
informed of such efforts. Upon [**] request, [**] shall reasonably cooperate
with [**] in such enforcement efforts, including by joining or instituting any
trademark litigation as a party where doing so is required for standing purposes
under applicable Law. If [**] does not bring such Action in the [**] Territory
within [**] days after the Parties’ discussion under the first sentence of this
Section 8.7.5, then [**] shall have the right to do so, consistent with the
agreed strategy for the [**] if there is a similar [**] case, and [**] shall
keep [**] reasonably informed of such efforts. Upon [**] request, [**] shall
reasonably cooperate with [**]in such enforcement efforts, including by joining
or instituting any trademark litigation as a party where doing so is required
for standing purposes under applicable Law. The costs incurred by the Parties
pursuant to this Section 8.7.5 shall be (a) considered [**] to the extent such
costs relate to enforcing the Product Trademarks in the US and (b) [**] by the
Parties in accordance with Section 7.4.2, to

 

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the extent such costs relate to enforcing the Product Trademarks in the Ex-US
Territory, and the [**] by the Parties pursuant to this Section 8.7.5 shall be
(x) considered Other Income in calculating Net Profit or Loss, to the extent
such recoveries arise from enforcing the Product Trademarks in the US and
(y) [**] by the Parties in accordance with Section 7.4.2, to the extent such
recoveries arise from enforcing the Product Trademarks in the Ex-US Territory.

ARTICLE 9.

CONFIDENTIALITY AND PUBLICITY

9.1. Confidential Information.

9.1.1. During the Term and for a period of [**] years after any termination or
expiration of this Agreement, or such longer period as may be required under any
Existing Infinity Third Party Agreement or Existing AbbVie Third Party
Agreement, each Party agrees to, and shall cause its Affiliates to, keep in
confidence and not to disclose to any Third Party, or use for any purpose,
except to exercise its rights or perform its obligations under this Agreement,
any Confidential Information of the other Party.

9.1.2. Each Party agrees that it and its Affiliates shall provide or permit
access to the other Party’s Confidential Information only to the receiving
Party’s employees, consultants, advisors and Sublicensees, and to the employees,
consultants and advisors of the receiving Party’s Affiliates, in each case who
are subject to obligations of confidentiality and non-use with respect to such
Confidential Information no less stringent than the obligations of
confidentiality and non-use of the receiving Party pursuant to this Section 9.1;
provided, that each Party shall remain responsible for any failure by its
Affiliates and Sublicensees, and its and its Affiliates’ respective employees,
consultants and advisors, to treat such Confidential Information as required
under Section 9.1 (as if such Affiliates, employees, consultants, advisors and
Sublicensees were parties directly bound to the requirements of this
Section 9.1).

9.1.3. Notwithstanding anything to the contrary herein, each Party may use and
disclose the other Party’s Confidential Information as follows: (a) under
appropriate written confidentiality obligations substantially equivalent to
those in this Agreement, to its Affiliates, potential and actual permitted
Sublicensees, contractors and any other Third Parties, to the extent such use or
disclosure is reasonably necessary to perform its obligations or to exercise its
rights under this Agreement, including but not limited to Section 4.1.6 herein;
(b) to the extent such disclosure is consistent with this Agreement and is
reasonably necessary for filing or prosecuting patent applications claiming the
Development, Manufacture or Commercialization of Licensed Compounds or Products;
(c) to its advisors (including financial advisors, attorneys and accountants),
actual or potential acquisition partners, financing sources or investors and
underwriters on a need to know basis, in each case under appropriate
confidentiality obligations (which may include professional ethical obligations)
substantially equivalent to those in this Agreement; or (d) to the extent such
disclosure is reasonably necessary: (i) in complying with the terms of the
Existing Infinity Third Party Agreements and AbbVie Third Party Agreements that
exist as of the Execution Date; (ii) in complying with the terms of agreements
with Third Parties related to Licensed Compounds or Products that are entered
into after the Execution Date; provided, that such agreements are entered into
in compliance with the terms of this Agreement; or (iii) in prosecuting or
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determined by such Party’s counsel, conducting Clinical Studies with respect to
a Product in accordance with this Agreement, in Regulatory Filings, filings for
Pricing and Reimbursement Approval or other communications or submissions to
Regulatory Authorities with respect to a Product in accordance with this
Agreement, or submitting information required to be submitted to Tax or other
Governmental Authorities.

9.2. Residual Knowledge Exception. Notwithstanding any provision of this
Agreement to the contrary, neither Party shall be liable for the internal use by
its employees of Residual Knowledge for the purpose of conducting research,
development and/or commercialization of pharmaceutical products for such Party
or its Affiliates; provided, that (a) no use or reference to written or
electronic copies of the disclosing Party’s Confidential Information or notes
from review or exposure to such disclosing Party’s Confidential Information
shall have been made to remember or complement such Residual Knowledge and
(b) any such use made by a receiving Party of Residual Knowledge is on an “as
is, where is” basis, with all faults and all representations and warranties
disclaimed and at its sole risk.

9.3. Publicity.

9.3.1. Initial Press Releases. Promptly following the Execution Date, the
Parties shall issue a mutually agreed press release regarding the subject matter
of this Agreement, including a description of the financial terms, scope of
planned Development and value of the Agreement, in the form attached hereto as
Exhibit E.

9.3.2. Further Publicity. The Parties acknowledge the importance of supporting
each other’s efforts to publicly disclose results and significant developments
regarding the Products in the Field that may include information that is not
otherwise permitted to be disclosed under this ARTICLE 9, and that may be beyond
what is required by Law, and each Party may make such disclosures from time to
time. Such disclosures may include achievement of milestones, significant events
in the Development process with respect to the Products, Commercialization
activities with respect to the Products and the like. Except for the initial
press releases described in Section 9.3.1:

(a) Whenever either Party elects to make any such public disclosure, it shall
first notify the other Party of such planned press release or public
announcement and provide a draft for review no less than [**] Business Days in
advance of issuing such press release or making such public announcement (or,
with respect to press releases and public announcements that are required by
applicable Law, with as much advance notice as possible under the circumstances
if it is not possible to provide notice no less than [**] Business Days in
advance). Each Party shall have the right to review and approve any such planned
press release or public announcement proposed by the other Party, including any
oral presentation or abstract, that contains Clinical Data or pertains to
results of Clinical Studies or other studies with respect to the Licensed
Compounds or Products, or that includes Confidential Information of the other
Party; provided, however, that (A) the reviewing Party shall attempt to provide
such approval as soon as reasonably possible and shall not unreasonably withhold
such approval; (B) the reviewing Party shall provide explanations of its
disapproval of such press release; and (C) a Party desiring to make such public
disclosure may issue such press release or public announcement without such
prior review by the other Party if (i) the contents of such press release or
public announcement have previously been made public other than through a breach
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such press release or public announcement does not materially differ from the
previously issued press release or other publicly available information; and
provided, further, that the other Party shall have the right to review, but not
approve, any press release or public announcement that the proposing Party
determines is required by applicable law based on the advice of counsel, which
public disclosures are subject to Section 9.3.2(b). The Party reviewing a press
release provided under this Section 9.3.2 will review and approve or disapprove
such press release within [**] Business Days after its receipt thereof. A press
release will be deemed approved if the reviewing Party does not provide its
disapproval during the reviewing period. If the reviewing Party disapproves of
the press release within the reviewing period, either Party may refer the matter
to the JSC for resolution together with the reasons for the withholding of
approval. The JSC will make a decision on such matter within [**] Business Days
after such referral. If the JSC cannot reach consensus on the matter within such
[**] Business Day period, such publication or public disclosure shall be deemed
not approved, notwithstanding anything in Section 2.9.3 to the contrary. For
clarity, in the event a publication contemplated by this Section 9.3.2
implicates a Third Party’s rights under a AbbVie Third Party Agreement or
Infinity Third Party Agreement, the counter party under such agreement shall be
considered a reviewing Party and shall have the right to review and approve any
planned press release or public announced proposed by the other Party, subject
to the terms and conditions set forth herein.

(b) The principles to be observed in such disclosures shall include accuracy,
compliance with applicable Law and regulatory guidance documents, reasonable
sensitivity to potential negative reactions of the FDA (and its foreign
counterparts) and the need to keep investors informed regarding the business of
the Party making such public disclosure. Nothing in this Section 9.3 shall
restrict a Party from making a disclosure required by Law as reasonably
determined by such Party’s counsel, including disclosures required by any laws
or regulations relating to the public sale of securities.

9.4. Publications.

9.4.1. Global Publication Strategy. The JMAC shall develop a global publication
strategy (with input from the JDC and JCC) for the publication or presentation
of scientific information related to the Licensed Compounds and Products in the
Field for approval by the JSC (the “Global Publication Strategy”). The JMAC may
from time to time develop and submit to the JSC for approval proposed
substantive amendments to the Global Publication Strategy. The JSC shall review
such proposed amendments presented and may approve such proposed amendments or
any other proposed amendments that the JSC may consider from time to time in its
discretion and, the Global Publication Strategy shall be amended accordingly.
The Parties acknowledge that each of Infinity and AbbVie has entered into
agreements with Third Parties prior to the Execution Date, and may enter into
agreements with Third Parties on or after the Execution Date, which permit such
Third Parties to make publications regarding Licensed Compounds or Products, and
agree that the Global Publication Strategy shall accommodate the ability of such
Third Parties to make such publications; provided, that any publications
contemplated by a Third Party under an Agreement with such Third Party that was
entered into on or after the Execution Date shall be subject to review and
comment by the other Party. Notwithstanding the foregoing (or Section 9.4.2),
the Global Publication Strategy shall not be construed to limit a Party’s rights
to make disclosures pursuant to Section 9.3.

 

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9.4.2. Approval of Publications.

(a) Except as set forth in Sections 9.3 or 9.4.2(b), the publication and
presentation of the results of Development carried out on the Licensed Compounds
and Products in the Field (whether such Development is carried out by a Party,
its Affiliates, Sublicensees or subcontractors) shall be governed by the Global
Publication Strategy, and the Parties agree to conduct their publication
activities in accordance with the Global Publication Strategy.

(b) Prior to the adoption of the Global Publication Strategy, the following
procedures shall apply with respect to the Parties’ or their Affiliates’
publication and presentation of the results of Development carried out on the
Licensed Compounds and Products in the Field: Prior to publishing or presenting
the results of any Development activities related to the Licensed Compounds or
Products, each Party (the “Publishing Party”) shall provide to the other Party
(the “Reviewing Party”) a copy of any proposed abstracts, manuscripts or
summaries of presentations that such Publishing Party intends to publish or
present (“Proposed Publications”). Each Party shall designate in writing an
individual(s) who shall be responsible for reviewing (or having reviewed) all
Proposed Publications submitted by the other Party and may change such
individual(s) on written notice to the other Party. Within [**] Business Days
after receipt by the Reviewing Party, a designated individual of the Reviewing
Party shall notify the Publishing Party in writing whether the Reviewing Party
has an objection to the Proposed Publication because such Proposed Publication
contains Confidential Information or patentable Know-How of the Reviewing Party
or the Reviewing Party believes in good faith that such Proposed Publication is
not in the best interests of the Exploitation of the Product. If a Reviewing
Party notifies a Publishing Party that it has such an objection, the Publishing
Party shall reasonably cooperate with the Reviewing Party to address such
concern. The Publishing Party shall reasonably consider any other suggestions of
the Reviewing Party. With respect to any proposed abstracts, manuscripts or
summaries of presentations that investigators or other Third Parties propose to
publish or present, such materials shall be subject to review under this
Section 9.42(b) to the extent that Infinity or AbbVie, as the case may be, has
the right to do so.

9.5. Public Filing of this Agreement. The Parties acknowledge that either or
both Parties may be obligated to file a copy of this Agreement or any Related
Agreement with the Securities & Exchange Commission or other Government
Authorities and each Party is hereby authorized to comply with such obligation;
provided, that each Party shall have the right to review and comment upon such
filing, such comments to be considered in good faith and to be included in any
such filing unless the filing Party has a good faith belief that the inclusion
of such comments or any proposed redactions would violate its disclosure
obligations under applicable securities law, or would adversely effect its
ability to ultimately obtain confidential treatment for such filing.

ARTICLE 10.

REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS

10.1. Mutual Representations and Warranties. Each Party represents and warrants
to the other Party that, as of the Execution Date:

 

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10.1.1. Organization. It is a corporation duly organized, validly existing, and
in good standing under the laws of the jurisdiction of its organization, and has
all requisite power and authority, corporate or otherwise, to execute, deliver,
and perform this Agreement.

10.1.2. Authority. It has full right, power and authority to enter into this
Agreement and to perform its respective obligations under this Agreement, it has
the right to grant to the other the licenses and sublicenses granted pursuant to
this Agreement, and this Agreement and the performance by such Party of this
Agreement do not violate such Party’s charter documents, bylaws or other
organizational documents.

10.1.3. Consents. Except for any Marketing Authorizations, Regulatory Filings,
manufacturing approvals or similar approvals necessary for the Development,
Manufacture or Commercialization of the Licensed Compounds and Products, all
necessary consents, approvals and authorizations of all Governmental Authorities
and other Persons required to be obtained by it in connection with the
execution, delivery and performance of this Agreement have been obtained.

10.1.4. No Conflict. It is not under any obligation, contractual or otherwise,
to any Person that would adversely affect the diligent and complete fulfillment
of obligations hereunder and the execution and delivery of this Agreement by
such Party, and the performance of such Party’s obligations hereunder (as
contemplated as of the Execution Date) and the licenses and sublicenses to be
granted by such Party pursuant to this Agreement (a) do not conflict with or
violate any requirement of Laws applicable to such Party, (b) do not conflict
with or violate any order, writ, judgment, injunction, decree, determination, or
award of any court or governmental agency presently in effect applicable to such
Party, and (c) do not conflict with, violate, breach or constitute a default
under any contractual obligations of such Party or any of its Affiliates.

10.1.5. Enforceability. This Agreement is a legal and valid obligation binding
upon it and is enforceable against it in accordance with its terms, subject to
the general principles of equity and subject to bankruptcy, insolvency,
moratorium, judicial principles affecting the availability of specific
performance and other similar Laws affecting the enforcement of creditors’
rights generally.

10.2. Additional Representations and Warranties of Infinity. Infinity represents
and warrants to AbbVie that, as of the Execution Date:

10.2.1. Existing Patents. All Infinity Patent Rights existing as of the
Execution Date are listed on Exhibit B (the “Existing Patents”). Infinity is,
with respect to each Existing Patent listed on Exhibit B-1 the sole and
exclusive owner of the entire right, title and interest in such Existing Patent;
and with respect to each Existing Patent listed on Exhibit B-2, the sole and
exclusive licensee of such Existing Patents. All Existing Patents are
(i) subsisting and in good standing and (ii) being diligently prosecuted in the
respective patent offices in the Territory in accordance with Law, and have been
filed and maintained properly and correctly and all applicable fees have been
paid on or before the due date for payment. To Infinity’s knowledge, all issued
Existing Patents are subsisting and are not invalid or unenforceable, in whole
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10.2.2. Existing Know-How. All Know-How being used by Infinity to Exploit the
Licensed Compound and Products as of the Execution Date (a) constitues Infinity
Know-How and is being licensed to AbbVie hereunder or (b) is generally known to
the public.

10.2.3. Delivery of Documentation. True, complete, and correct copies of:
(a) all Existing Regulatory Filings relating to the Product; and (b) all
material adverse information with respect to the safety and efficacy of the
Licensed Compound known to Infinity, in each case ((a) and (b)) have been
provided or made available to AbbVie prior to the Execution Date.

10.2.4. Third Party Challenges to Infinity IP. There are no claims, judgments,
or settlements against, or amounts with respect thereto, owed by Infinity or any
of its Affiliates relating to the Existing Patents or the Infinity Know-How. No
claim or litigation has been brought or, to Infinity’s knowledge, threatened by
any Person (a) alleging that the Existing Patents are invalid or unenforceable,
(b) asserting the misuse, or non-infringement of any of the Infinity Patent
Rights, (c) challenging Infinity’s Control of the Infinity Patent Rights or
(d) alleging misappropriation of the Infinity Know-How.

10.2.5. Ownership and Encumbrances. Except as set forth in the Existing Infinity
Third Party Agreements, the Infinity Patent Rights are free and clear of any
liens, charges, encumbrances or, to Infinity’s knowledge, claims of ownership by
any Third Party, other than (a) non-exclusive licenses granted by Infinity to
Third Parties, which grants are not in conflict with, and do not preclude AbbVie
from exercising, the licenses granted to AbbVie hereunder, or of the nature of
material transfer agreements, clinical trial agreements and manufacturing
agreements, which will not adversely affect AbbVie’s ability to Develop,
Manufacture and Commercialize the Products in accordance with this Agreement,
and (b) the rights of the relevant Third Party counterparties to the Existing
Infinity Third Party Agreements and their licensors. Infinity is entitled to
grant the licenses specified in the Agreement.

10.2.6. Non-Infringement of Third Party IP. To Infinity’s knowledge, the
Development, Manufacture and Commercialization of the Licensed Compounds or
Products, as conducted by Infinity prior to the Execution Date did not infringe
any then-issued Patent Right or misappropriate any then-existing Know-How or
other intellectual property or proprietary right of any Person. To Infinity’s
knowledge, the Development, Manufacture and Commercialization of the Licensed
Compounds or Products as specifically described in the initial GDP attached
hereto as Exhibit C (other than the Combination Clinical Studies) would not
infringe any Patent Right issued as of the Effective Date or misappropriate any
Know-How or other intellectual property or proprietary right of any Person
existing as of the Effective Date. To Infinity’s knowledge, the Infinity Patent
Rights and Infinity Know-How comprise all of the Patent Rights and Know-How
necessary for Developing the Licensed Compound and Product, other than Patent
Rights and Know-How necessary for Developing any other active ingredient in
Combination Products, in accordance with the Development Plan and for
Commercializing the Product as it exists on the Execution Date. No written claim
of infringement of the Patent Rights or misappropriation of the Know-How of any
Third Party has been made, or to Infinity’s knowledge, threatened, against
Infinity or any of its Affiliates with respect to the Development, Manufacture
or Commercialization of the Licensed Compound or Products.

 

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10.2.7. Absence of Litigation. Except as identified in Schedule 10.2.7, there
are no judgments or settlements against or owed by Infinity or, to Infinity’s
knowledge, pending litigation against Infinity or litigation threatened against
Infinity in writing, in each case related to the Product, including any relating
to any Regulatory Filings Controlled by Infinity as of the Effective Date.

10.2.8. US Government Rights. Neither Infinity nor any of its Affiliates is or
has been a party to any agreement with the U.S. federal government or an agency
thereof pursuant to which the U.S. federal government or such agency provided
funding for the Development of a Licensed Compound or Product, and the
inventions claimed or covered by the Existing Patents are not a “subject
invention” as that term is described in 35 U.S.C. Section 201(f).

10.2.9. Existing Infinity Third Party Agreements. (a) The Existing Infinity
Third Party Agreements existing as of the Execution Date are the only agreements
between Infinity and any Third Party pursuant to which Infinity has in-licensed
any Existing Patents or pursuant to which Infinity owes any Third Party any
royalties with respect to Licensed Compounds or Products; (b) prior to the
Execution Date, Infinity has provided AbbVie with an opportunity to review
complete and correct copies of the Existing Infinity Third Party Agreements
existing as of the Execution Date; (c) to Infinity’s knowledge, such Existing
Infinity Third Party Agreements remain in full force and effect as of the
Execution Date; (d) as of the Execution Date, Infinity is in material compliance
with the terms of such Existing Infinity Third Party Agreements and, to
Infinity’s knowledge, the counterparties to such Existing Infinity Third Party
Agreements are in material compliance with the terms of such Existing Infinity
Third Party Agreements; and (e) Infinity has obtained any and all consents
required under such Third Party Agreements as may be necessary to perform its
obligations under this Agreement. Without limiting Section 10.1.4, the terms of
this Agreement do not breach or constitute a default under the terms of any
Existing Infinity Third Party Agreement.

10.2.10. Maintenance of Regulatory Filings, Good Laboratory and Clinical
Practices. Infinity and its Affiliates have generated, prepared, maintained, and
retained all Regulatory Filings that are required to be maintained or retained
pursuant to and in material compliance with applicable Law, and have conducted
in material compliance with applicable Law, including GLP and GCP, (a) all
Development of the Licensed Compound or the Products in the Field that they have
conducted prior to the Execution Date and (b) all Research activities that are
material to the receipt of Regulatory Approval for the Product.

10.2.11. Confidentiality of Know-How. To the knowledge of Infinity and its
Affiliates, no material breach of confidentiality has been committed by any
Third Party with respect to the Infinity Know-How and Infinity has used
reasonable measures to protect the confidentiality thereof.

10.2.12. Assignment of Third Party Rights.

(a) Infinity has obtained from each of its Affiliates, employees and agents, and
from the employees and agents of its Affiliates, who are participating in the
Exploitation of the Licensed Compound or Products, rights to any and all
Know-How created by such employees and agents that relates to the Licensed
Compound or Products, such that AbbVie

 

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shall, by virtue of this Agreement, receive from Infinity, without payments
beyond those required by ARTICLE 7, the licenses and other rights granted to
AbbVie hereunder, except with respect to those Persons from whom obtaining such
rights is not customary, such as academic and non-profit Persons.

(b) Each Person who has or has had any ownership rights in or to any Existing
Patents purported to be owned solely by Infinity, has assigned and has executed
an agreement assigning its entire right, title, and interest in and to such
Existing Patents to Infinity; to Infinity’s knowledge, no current officer,
employee, agent, or consultant of Infinity or any of its Affiliates is in
violation of any term of any assignment or other agreement, in each case,
regarding the protection of Patents or other intellectual property or
proprietary information of Infinity or such Affiliate.

(c) Infinity and its Affiliates have employed (and, with respect to such tests
and studies that Infinity will employ) Persons with appropriate education,
knowledge and experience to conduct and to oversee the conduct of the
pre-clinical and clinical studies with respect to the Licensed Compound and
Products.

10.2.13. Statements to FDA and Other Regulatory Authorities. Neither Infinity
nor any of its Affiliates, nor any of its or their respective officers,
employees, or agents has made an untrue statement of material fact or fraudulent
statement to the FDA or any other Regulatory Authority with respect to the
Development of the Licensed Compound or the Products, failed to disclose a
material fact required to be disclosed to the FDA or any other Regulatory
Authority with respect to the Development of the Licensed Compound or the
Products, or committed an act, made a statement, or failed to make a statement
with respect to the Development of the Licensed Compound or the Products that
could reasonably be expected to provide a basis for the FDA to invoke its policy
respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal
Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any
amendments thereto or any analogous laws or policies in the Territory.

10.3. Additional Representations and Warranties of AbbVie. AbbVie represents and
warrants to Infinity that as of the Execution Date:

10.3.1. to its knowledge, AbbVie and its Affiliates do not own or Control any
Patent Rights that Cover or claim any Licensed Compound, Product, or Exclusivity
Compound, or the use of any of the foregoing.

10.3.2. neither AbbVie nor any of its Affiliates have received notice that
AbbVie or its Affiliates do not have, or will not have, the right to conduct the
Combination Clinical Studies.

10.3.3. AbbVie is not subject to any non-compete or other restrictions that
would impair its ability to Develop and Commercialize the Licensed Compound or
Product in the Field in the Territory as contemplated on the Execution Date.

10.4. No Debarment. Each Party represents and warrants that neither it nor any
of its or its Affiliates’ employees or agents performing hereunder has ever
been, or is currently: (A) debarred under 21 U.S.C. § 335a; (B) excluded,
debarred, suspended, or otherwise ineligible to participate in Federal health
care programs or in Federal procurement or non-procurement

 

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programs; (C) listed on the FDA’s Disqualified and Restricted Lists for clinical
investigators; or (D) convicted of a criminal offense that falls within the
scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred,
suspended, or otherwise declared ineligible. Each Party further covenants that
if, during the term of this Agreement, it becomes aware that it or any of its or
its Affiliates’ employees or agents performing hereunder is the subject of any
investigation or proceeding that could lead to that Party becoming a debarred
entity or individual, an excluded entity or individual or a convicted entity or
individual, such Party shall immediately notify the other Party, and the other
Party shall have the right to immediately terminate this agreement in accordance
with Section 12.2. This provision shall survive termination or expiration of
this Agreement.

10.5. No Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT
OR ANY RELATED AGREEMENT, NEITHER PARTY NOR ANY OF ITS AFFILIATES MAKES ANY
REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
TO THE OTHER PARTY OR ANY OF ITS AFFILIATES, AND EACH PARTY HEREBY DISCLAIMS ALL
IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. EACH PARTY
UNDERSTANDS THAT THE LICENSED COMPOUNDS AND PRODUCTS ARE THE SUBJECT OF ONGOING
CLINICAL RESEARCH AND DEVELOPMENT, AND THAT NEITHER PARTY CAN ASSURE, AND EACH
PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY, THAT THE DEVELOPMENT,
MANUFACTURE AND COMMERCIALIZATION OF THE LICENSED COMPOUNDS AND PRODUCTS
PURSUANT TO THIS AGREEMENT WILL RECEIVE REGULATORY APPROVAL OR WILL BE SAFE,
EFFECTIVE, USEFUL OR SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT
TO THE PRODUCTS WILL BE ACHIEVED.

10.6. Covenants with Respect to Infinity Third Party Agreements.

10.6.1. Acknowledgement. AbbVie acknowledges and agrees, subject to the accuracy
of the representations and warranties contained in Section 10.2.9, that (a) it
has received a copy of the Existing Infinity Third Party Agreements existing as
of the Execution Date and (b) all rights granted to and obligations (including
any financial obligations) of AbbVie hereunder are subject to the terms and
conditions of the Existing Infinity Third Party Agreements.

10.6.2. Compliance. AbbVie shall, and shall cause its Affiliates and
Sublicensees to, comply in all material respects with the Infinity Third Party
Agreements and take any action reasonably requested by Infinity, to prevent any
potential material breach by AbbVie, its Affiliates or Sublicensees of any term
of any Infinity Third Party Agreement. Without limiting the generality of the
foregoing, the Third Party counterparty to any Infinity Third Party Agreement
(and their licensors) shall have the same rights of audit and inspection with
respect to AbbVie and its Affiliates and Sublicensees as granted by Infinity to
such Third Party counterparty (or its licensor) pursuant to the applicable
Infinity Third Party Agreement, provided, however, that (a) any audit conducted
by a Third Party counterparty to any Infinity Third Party Agreement (or such
party’s licensor) shall constitute an audit conducted by Infinity for purposes
of Section 7.5 of this Agreement and (b) any such audit shall be limited to the
scope set forth in Section 7.5 of this Agreement.

 

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10.6.3. Termination and Amendments. Infinity shall not, without AbbVie’s prior
written consent (which shall not be unreasonably withheld), terminate, or enter
into any amendment to, any Infinity Third Party Agreement which termination or
amendment would have an adverse effect, in any material respect, on AbbVie’s
rights or obligations under this Agreement or on the Development, Manufacture or
Commercialization of the Products as contemplated hereunder. To the extent
permitted under the relevant Infinity Third Party Agreement, Infinity shall
provide AbbVie with a copy of all modifications to or amendments of the Infinity
Third Party Agreements, regardless of whether AbbVie’s consent was required with
respect thereto.

10.6.4. Breach of Infinity Third Party Agreements. Each Party shall use Diligent
Efforts not to perform any acts or omissions that would constitute a breach of
any of the Infinity Third Party Agreements which breach would have an adverse
effect, in any material respect, on the Development, Manufacture or
Commercialization of the Products as contemplated hereunder. Each Party shall
provide the other promptly with notice of the occurrence of any such breach (or
receipt of notice of an allegation of any such breach). AbbVie may deduct from
payments due to Infinity any expenses incurred by AbbVie to cure any breach by
Infinity of an Infinity Third Party Agreement, unless such breach was caused by
AbbVie (including AbbVie’s breach of any obligation hereunder).

10.6.5. Intellikine Agreement.

(a) Subject to the terms of this Section 10.6.5, the sublicenses granted to
AbbVie hereunder with respect to the Patent Rights and Know-How licensed to
Infinity pursuant to the Intellikine Agreement shall terminate upon termination
of the Intellikine Agreement (except as provided in Section 15.1(b) therein) and
the provisions of Section 15.2 of the Intellikine Agreement shall, to the extent
applicable to AbbVie, apply, except that any such sublicense to AbbVie of the
rights granted to Infinity under Section 2.1 of the Intellikine Agreement to
develop or commercialize Licensed Compounds or Products shall not terminate upon
termination of the Intellikine Agreement but instead shall remain in full force
and effect if AbbVie is not then in material breach of this Agreement and AbbVie
provides to Intellikine within thirty (30) days after termination of the
Intellikine Agreement a written agreement to be bound as AbbVie under the terms
and conditions of the Intellikine Agreement as to the field and territory in
which AbbVie has been granted rights under this Agreement.

(b) If, as a result of AbbVie’s acts or omissions, Infinity breaches its
obligations under the Intellikine Agreement, Infinity shall provide AbbVie with
prompt written notice of the actions or omissions by AbbVie causing such breach
upon becoming aware of such breach (such actions and omissions, a “Headlicense
Breach”). AbbVie shall have an opportunity to cure such Headlicense Breach in
accordance with the terms set forth in Section 12.2.1 (but without any extension
of the cure period therein), so long as AbbVie provides evidence to Infinity
during such cure period of its actions to cure such breach. If AbbVie fails to
cure its Headlicense Breach or to provide evidence of such actions in accordance
with the preceding sentence, AbbVie’s Headlicense Breach shall be considered a
material breach of this Agreement by AbbVie, which material breach shall not be
subject to any further cure periods under Section 12.2.1 of this Agreement.

 

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(c) In the event the Intellikine Agreement is terminated for any reason other
than a Headlicense Breach or other than any action by AbbVie giving rise to a
right for Infinity to terminate this Agreement under Section 12.2.3 and AbbVie
enters an agreement to be bound as AbbVie under the terms and conditions of the
Intellikine Agreement or otherwise acquires or licenses rights from Intellikine
permitting AbbVie to develop or commercialize Licensed Compounds or Products,
with the right to sublicense such rights to Infinity, then all payments made or
owing by AbbVie pursuant to such agreement shall be deducted from and recouped
against all payments made or owing by AbbVie to Infinity under this Agreement.

10.7. Covenants with Respect to AbbVie Third Party Agreements.

10.7.1. Notwithstanding anything to the contrary herein, all rights, licenses
and sublicenses granted by AbbVie to Infinity, and all obligations imposed on
Infinity, hereunder or under any Related Agreement are subject to, and shall be
construed in accordance with, the AbbVie Third Party Agreements, and nothing
herein shall be interpreted in a manner inconsistent with Infinity’s obligations
under any AbbVie Third Party Agreement.

10.7.2. Infinity shall, and shall cause its Affiliates and Sublicensees to,
comply in all material respects with the AbbVie Third Party Agreements and take
any action reasonably requested by AbbVie, to prevent any potential material
breach by Infinity, its Affiliates or Sublicensees of any term of any AbbVie
Third Party Agreement. Without limiting the generality of the foregoing, the
Third Party counterparty to any AbbVie Third Party Agreement (and their
licensors) shall have the same rights of audit and inspection with respect to
Infinity and its Affiliates and Sublicensees as granted by AbbVie to such Third
Party counterparty (or its licensor) pursuant to the applicable AbbVie Third
Party Agreement, provided, however, that (a) any audit conducted by a Third
Party counterparty to any AbbVie Third Party Agreement (or such party’s
licensor) shall constitute an audit conducted by AbbVie for purposes of
Section 7.5 of this Agreement and (b) any such audit shall be limited to the
scope set forth in Section 7.5 of this Agreement.

10.7.3. AbbVie shall not, without Infinity’s prior written consent (which shall
not be unreasonably withheld), terminate, or enter into any amendment to, any
AbbVie Third Party Agreement which termination or amendment would have a
material adverse effect on Infinity’s rights or obligations under this Agreement
or on the Development, Manufacture or Commercialization of the Products as
contemplated hereunder. To the extent permitted under the relevant AbbVie Third
Party Agreement, AbbVie shall provide Infinity with a copy of all modifications
to or amendments of the AbbVie Third Party Agreements, regardless of whether
Infinity’s consent was required with respect thereto.

10.7.4. Notwithstanding anything to the contrary herein, the rights, licenses
and sublicenses granted by AbbVie to Infinity in this Agreement or any Related
Agreement are subject to the terms and conditions of the applicable AbbVie Third
Party Agreements, and the rights granted to or retained by the counterparties
thereunder or their licensors.

 

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10.7.5. Each Party shall use Diligent Efforts not to perform any acts or
omissions that would constitute a breach of any of the AbbVie Third Party
Agreements which breach would have a material adverse effect on the Development,
Manufacture or Commercialization of the Products as contemplated hereunder. Each
Party shall provide the other promptly with notice of the occurrence of any such
breach (or receipt of notice of an allegation of any such breach).

10.7.6. AbbVie shall (a) use Diligent Efforts to comply with the terms of each
AbbVie Third Party Agreement; and (b) promptly notify Infinity in writing if
AbbVie receives any notice alleging breach with a AbbVie Third Party Agreement
or terminating, or purporting to terminate, a AbbVie Third Party Agreement. In
the event that AbbVie receives written notice alleging that it is in breach of
any AbbVie Third Party Agreement, AbbVie shall advise Infinity thereof and
provide Infinity with a copy of such notice to the extent permitted under such
AbbVie Third Party Agreement. In the event that AbbVie does not cure or
challenge the breach alleged in such notice (which may include causing the
counterparty to such AbbVie Third Party Agreement to retract such allegation) by
the date that is five (5) days before the date on which such counterparty would
be permitted to terminate such AbbVie Third Party Agreement due to such breach,
then Infinity shall have the right, to the extent practicable and to the extent
permitted under such AbbVie Third Party Agreement, to remedy the situation
alleged in such notice and AbbVie shall reimburse Infinity for any Out-of-Pocket
Costs that Infinity reasonably incurs in remedying such breach.

10.8. Insurance. Each Party, at its own expense, shall maintain liability
insurance (or self-insure) with respect to its activities hereunder in an amount
consistent with industry standards. Each Party shall provide a certificate of
insurance (or evidence of self-insurance) evidencing such coverage to the other
Party upon request. Without limiting the foregoing, during the Term and
thereafter for the period of time required below, each Party shall maintain on
an ongoing basis comprehensive general liability insurance in the minimum amount
of $[**] per occurrence and $[**] annual aggregate combined single limit for
bodily injury and property damage liability; and products liability insurance
(including contractual liability coverage on such Party’s indemnification
obligations under this Agreement) in the amount of at least $[**] per occurrence
and as an annual aggregate combined single limit for bodily injury and property
damage liability; provided, however, that (a) prior to the initiation of any
Clinical Study, the Party responsible for such Clinical Study shall secure and
maintain in full force and effect clinical trial insurance in compliance with
applicable Law in those countries where such Clinical Study is conducted, and
(b) commencing not later than [**] days prior to the reasonably anticipated
First Commercial Sale of a Licensed Compound or Product, and thereafter for the
period of time required below, each Party shall obtain and maintain on an
ongoing basis products liability insurance (including contractual liability
coverage on such Party’s indemnification obligations under this Agreement) in
the amount of at least $[**] per occurrence and as an annual aggregate combined
single limit for bodily injury and property damage liability. All of such
insurance coverage may be maintained through a self-insurance plan that
substantially complies with the foregoing limits and requirements and may be
satisfied through one or more policies, including an umbrella policy; provided,
that such self-insurance is determined to be investment quality by a recognized
rating agency such as Moody’s or Standard & Poor’s. Not later than [**] days
following receipt of written request from a Party, the other Party shall provide
to the requesting Party a letter(s) affirming appropriate self-insurance and/or
a certificate of insurance evidencing such coverage in accordance with this
Agreement. Each Party shall maintain such insurance or self-insurance coverage
without interruption during the Term and for a period of [**] years thereafter,
and, if

 

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applicable, shall provide certificates and/or letters evidencing such insurance
coverage without interruption as reasonably requested during the period of time
for which such coverage must be maintained. Each Party shall be provided at
least [**] days’ prior written notice of any cancellation or material decrease
in the other Party’s insurance coverage limits described above. Notwithstanding
the foregoing, either Party’s failure to maintain adequate insurance shall not
relieve that Party of its obligations set forth in this Agreement.

ARTICLE 11.

INDEMNIFICATION

11.1. General Indemnification By Infinity. Infinity shall indemnify and hold
harmless AbbVie, its Affiliates and their respective directors, officers,
employees and agents (collectively, the “AbbVie Indemnified Parties”), from,
against and in respect of any and all Losses incurred or suffered by any AbbVie
Indemnified Party to the extent resulting from: (a) any breach of, or inaccuracy
in, any representation or warranty made by Infinity in this Agreement, or any
breach or violation by Infinity of any covenant or agreement in this Agreement;
(b) the negligence or intentional misconduct of, or violation of Law by,
Infinity, any of its Affiliates or Sublicensees, or any of their respective
directors, officers, employees and agents, in performing Infinity’s obligations
or exercising Infinity’s rights under this Agreement; (c) activities conducted
by Infinity or its Affiliates related to the Development, Manufacture, or other
Exploitation of the Products or the Licensed Compounds anywhere in the world
prior to the Execution Date, other than product liability claims; and
(d) subject to Section 12.3.10, the Development, Commercialization, Manufacture,
or other Exploitation of any Products or the Licensed Compounds anywhere in the
world after the termination of this Agreement.

11.2. General Indemnification By AbbVie. AbbVie shall indemnify and hold
harmless Infinity, its Affiliates and their respective directors, officers,
employees and agents (collectively, the “Infinity Indemnified Parties”), from,
against and in respect of any and all Losses incurred or suffered by any
Infinity Indemnified Party to the extent resulting from: (a) any breach of, or
inaccuracy in, any representation or warranty made by AbbVie in this Agreement,
(b) any breach or violation by AbbVie of any covenant or agreement in this
Agreement, or (c) the negligence or intentional misconduct of, or violation of
Law by, AbbVie, any of its Affiliates or Sublicensees, or any of their
respective directors, officers, employees and agents, in performing AbbVie’s
obligations or exercising AbbVie’s rights under this Agreement.

11.3. Claims for General Indemnification. With respect to a Product Liability
Action, Section 11.4, rather than this Section 11.3, shall apply to the extent
set forth therein.

11.3.1. Notice. An Indemnified Party entitled to indemnification under Sections
11.1 or 11.2 shall give prompt written notification to the Indemnifying Party
from whom indemnification is sought of the commencement of any Action by a Third
Party for which indemnification may be sought (a “Third Party Claim”) or, if
earlier, upon the assertion of such Third Party Claim by a Third Party;
provided, however, that failure by an Indemnified Party to give notice of a
Third Party Claim as provided in this Section 11.3.1 shall not relieve the
Indemnifying Party of its indemnification obligation under this Agreement,
except and only to the extent that such Indemnifying Party is actually
prejudiced as a result of such failure to give notice.

 

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11.3.2. Defense. Within [**] days after delivery of a notice of any Third Party
Claim in accordance with Section 11.3.1, the Indemnifying Party may, upon
written notice thereof to the Indemnified Party, assume control of the defense
of such Third Party Claim with counsel reasonably satisfactory to the
Indemnified Party. If the Indemnifying Party does not assume control of such
defense, the Indemnified Party shall control such defense. The Party not
controlling such defense may participate therein at its own expense.

11.3.3. Cooperation. The Party controlling the defense of any Third Party Claim
shall keep the other Party advised of the status of such Third Party Claim and
the defense thereof and shall reasonably consider recommendations made by the
other Party with respect thereto. The other Party shall reasonably cooperate
with the Party controlling such defense and its Affiliates and agents in defense
of the Third Party Claim, with all Out-of-Pocket Costs of such cooperation to be
borne by the Party controlling such defense.

11.3.4. Settlement. The Indemnified Party shall not agree to any settlement of
such Third Party Claim without the prior written consent of the Indemnifying
Party, which shall not be unreasonably withheld. The Indemnifying Party shall
not, without the prior written consent of the Indemnified Party, which shall not
be unreasonably withheld, agree to any settlement of such Third Party Claim or
consent to any judgment in respect thereof that does not include a complete and
unconditional release of the Indemnified Party from all liability with respect
thereto or that imposes any liability or obligation on the Indemnified Party.

11.3.5. Allocation of Costs. For clarity, all costs incurred pursuant to this
Section 11.3 shall be excluded from Development Costs and Allowable Expenses.

11.4. Conduct of Product Liability Actions.

11.4.1. Each Party shall promptly notify the other if any Third Party files a
Product Liability Action against such Party or any of its Affiliates. In the
event of a Product Liability Action against a single Party, the unnamed Party
shall have the right, in the unnamed Party’s sole discretion, to join or
otherwise participate in such Action with legal counsel selected by the unnamed
Party and reasonably acceptable to the named Party. The Party named in such
Product Liability Action shall have the right to control the defense of the
action, but shall notify and keep the unnamed Party apprised in writing of such
action and shall consider and take into account the unnamed Party’s reasonable
interests and requests and suggestions regarding the defense of such action. In
the event of a Product Liability Action against both Parties, the Parties shall
mutually agree upon which Party shall control the response to such Product
Liability Action.

11.4.2. The unnamed Party of a Product Liability Action shall reasonably
cooperate with the named Party in the preparation and formulation of a defense
to such Product Liability Action, and in taking other steps reasonably necessary
to respond to such Product Liability Action. The named Party shall have the sole
and exclusive right to select its counsel for the defense to such Product
Liability Action. If required under applicable Law in order for the named Party
to maintain a suit in response to such Product Liability Action, the unnamed
Party shall join as a party to the suit. The unnamed Party shall also have the
right to participate and be represented in any such suit by its own counsel. The
named Party shall not settle or compromise any Product Liability Action without
the consent of the other Party, which consent shall not be unreasonably
withheld.

 

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11.4.3. With respect to Product Liability Actions arising in the Ex-US
Territory, except with respect to such portion (if any) of Product Liability
Costs that are Losses entitled to indemnification under Sections 11.1 or 11.2,
which shall be solely borne by the relevant Indemnifying Party, all Product
Liability Costs related to such actions shall be borne by the Party incurring
such costs. With respect to Product Liability Actions arising in the US, except
with respect to such portion (if any) of Product Liability Costs that are Losses
entitled to indemnification under Sections 11.1 or 11.2, which shall be solely
borne by the relevant Indemnifying Party, all Product Liability Costs related to
such actions shall be considered “Shared Product Liability Costs” and included
in Allowable Expenses.

ARTICLE 12.

TERM AND TERMINATION

12.1. Term. Unless terminated earlier in accordance with this ARTICLE 12, this
Agreement becomes effective as of the Effective Date and shall remain in force
for the period commencing on the Effective Date and ending upon the cessation of
all Development, Manufacturing and Commercialization activities with respect to
all Licensed Compounds and Products (the “Term”).

12.2. Early Termination.

12.2.1. Termination for Material Breach.

(a) Termination for Material Breach. Upon (i) any material breach of this
Agreement by Infinity or (ii) any material breach of this Agreement by AbbVie,
other than a material breach as set forth below in Section 12.2.1(c) or
12.2.1(d) (the Party so allegedly breaching being the “Breaching Party”), the
other Party (the “Non-Breaching Party”) shall have the right, but not the
obligation, to terminate this Agreement in its entirety by providing [**] days
written notice to the Breaching Party in the case of a material breach of a
payment obligation and [**] days written notice to the Breaching Party in the
case of any other material breach, which notice shall, in each case
(a) expressly reference this Section 12.2.1, (b) reasonably describe the alleged
breach which is the basis of such termination, and (c) clearly state the
Non-Breaching Party’s intent to terminate this Agreement if the alleged breach
is not cured within the applicable cure period. Notwithstanding the foregoing,
(x) if the alleged material breach by AbbVie is that it has failed to use
Diligent Efforts to seek Regulatory Approval for or Commercialize the Product in
a particular country in the Ex-US Territory under Section 5.1.3(b), then
Infinity shall have the right to terminate this Agreement solely with respect to
such country (and not in its entirety); and (y) AbbVie may elect, in lieu of
terminating this Agreement, to proceed as set forth below in Section 12.2.1(b)
and 12.2.1(d) in the case of material breach by Infinity. The termination shall
become effective at the end of the notice period unless the Breaching Party
cures such breach during such notice period; provided, that the Non-Breaching
Party may, by notice to the Breaching Party, designate a later date for such
termination in order to facilitate an orderly transition of activities relating
to the Product. Notwithstanding the foregoing, (1) if such material breach
(other than a payment breach), by its nature, is curable, but is not reasonably
curable within the applicable cure period, then such cure period shall be
extended if the Breaching Party provides a written plan for curing such breach
to the Non-Breaching Party and uses Diligent Efforts to cure such breach in
accordance with such written plan; provided, that no such extension shall exceed
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the consent of the Non-Breaching Party; and (2) if the Breaching Party disputes
that it has materially breached this Agreement, the dispute shall be resolved
pursuant to ARTICLE 13. If, as a result of the application of such dispute
resolution procedures, the Breaching Party is determined to be in material
breach of this Agreement (an “Adverse Ruling”), then if the Breaching Party
fails to cure such material breach within [**] days after such ruling (whether
or not such actions are specified by the Adverse Ruling) (or [**] days after
such ruling in the case of a payment breach), then the Non-Breaching Party may
terminate this Agreement upon written notice to the Breaching Party as provided
in this Section 12.2.1(a).

(b) Breach by Infinity of its Development Obligations. If Infinity materially
breaches its obligation under Section 4.3.1 to use Diligent Efforts to conduct
the Development of the Licensed Compound, including a material breach of its
obligations under any Regulatory Approval, then following the notice and cure
periods, and where applicable, any Adverse Ruling, all as described in
Section 12.2.1(a), AbbVie shall have the right, in lieu of terminating this
Agreement in its entirety, to terminate only that portion of this Agreement that
provides Infinity with the right to conduct Development activities and to
thereafter assume the conduct of all Development activities allocated to
Infinity under the GDP upon thirty (30) days written notice to Infinity (or such
longer period as AbbVie may determine is needed to implement such transition).
In such event, the Development Costs for such assumed Development activities
shall remain solely the obligation of Infinity, up to the Development Threshold,
and thereafter, shared equally by the Parties in accordance with Section 4.6.1.
To the extent Infinity fails to fund such assumed Development activities by
AbbVie, AbbVie shall, in addition to any other remedies (including the right to
terminate this Agreement under Section 12.2.1(a)), fund such amounts consistent
with the then-current GDP and Development Budget, and such amounts shall be
deducted and recouped from any amounts thereafter owing to Infinity. No
assumption of Development activities shall alter Infinity’s rights to share in
the Net Profit or Loss in the US, or receive milestones and royalties set forth
in ARTICLE 7 and Schedule 7 or any other economic provisions of this Agreement.

(c) Breach by AbbVie of its Development Obligations. If AbbVie materially
breaches its Development diligence obligations under Section 4.3.1, then
Infinity shall not have the right to terminate this Agreement, but rather
Infinity shall have the right to terminate only that portion of this Agreement
that provides AbbVie with the right to conduct Development activities, and
thereafter assume the conduct of all such Development activities under the GDP,
following the notice and cure periods, and where applicable any Adverse Ruling,
all described in Section 12.2.1(a), upon thirty (30) days written notice to
AbbVie; provided, however, that in no event will Infinity have the right to
conduct any Clinical Study that includes the AbbVie Combination Compound, in
combination with the Licensed Compound or cast a deciding vote with respect to
such matters. Such assumption will not affect the allocation of Development
Costs of such assumed Development activities as set forth in Section 4.6.1, nor
any other economic provisions of this Agreement.

(d) Breach of Commercialization Obligations by Either Party. If (i) AbbVie
materially breaches its obligations to use Diligent Efforts to Co-Promote the
Product in the US, or (ii) Infinity materially breaches its obligations to use
Diligent Efforts to either (x) Co-Promote the Product, (y) distribute and sell
the Product, or (z) provide patient services, in each case, in the US, then the
Non-Breaching Party shall have the right, following the notice and cure

 

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periods, and where applicable any Adverse Ruling, all described in
Section 12.2.1(a), to (A) terminate only that portion of this Agreement that
provides the Breaching Party with the right to so conduct just those
Commercialization activities that gave rise to such material breach, and
thereafter assume the right to conduct just such Commercialization activities
itself (e.g., in the case of uncured material breach by Infinity of its
obligations to distribute and sell the Product, AbbVie would have the right to
terminate Infinity’s rights to conduct such activities and to assume such
activities, the breaching Party would have the right continue conducting all
other Commercialization activities for which it is responsible hereunder) and
(B) notwithstanding Section 2.9.3, cast a deciding vote with respect to all
matters referred to the Executive Officers by the JSC pursuant to Section 2.9.2
relating to such Commercialization activities under this Agreement consistent
with such Party’s diligence obligations under this Agreement. If AbbVie
terminates Infinity’s rights to distribute and sell the Product in the US
Territory in accordance with Section 5.5, then AbbVie shall distribute and sell
the Product and the terms of Section 7.2.1 and Section 7.5 shall apply mutatis
mutandis to the Parties.

(e) Recoupment. If a Party materially breaches this Agreement and the other
Party is awarded damages pursuant to a dispute resolution procedure under
ARTICLE 13, then the Party awarded such damages, in addition to any other
remedies, shall recoup any unrecovered damages against payments due the
breaching Party under this Agreement.

12.2.2. Termination by AbbVie Unilaterally.

(a) AbbVie may, upon ninety (90) days’ prior written notice to Infinity, which
notice expressly references this Section 12.2.2, unilaterally terminate this
Agreement without cause.

(b) If AbbVie provides notice of termination pursuant to Section 12.2.2(a), this
Agreement shall remain in full force and effect until the effective date of such
termination. In the event of termination pursuant to Section 12.2.2(a), during
the period from the date of AbbVie’s notice of termination until the effective
date of termination, all licenses and rights granted to AbbVie under this
Agreement shall be non-exclusive.

12.2.3. Challenges of Infinity Patent Rights. If AbbVie or any of its Affiliates
or Sublicensees (a) commences or participates in any Action (including any
patent opposition, re-examination or invalidation proceeding), or otherwise
asserts any claim, challenging or denying the validity or enforceability of any
Infinity Patent Right or any claim thereof or (b) actively and knowingly assists
any Person in bringing or prosecuting any Action (including any patent
opposition, re-examination or invalidation proceeding) challenging or denying
the validity or enforceability of any Infinity Patent Right or any claim thereof
(each of (a) and (b), a “Patent Challenge”), then, to the extent permitted by
Law, Infinity may, in its sole discretion, give at least thirty (30) days prior
written notice to AbbVie that Infinity may terminate this Agreement, and, unless
AbbVie, its Affiliates and Sublicensees, as applicable, withdraw or cause to be
withdrawn all such challenges (or in the case of ex-parte proceedings,
multi-party proceedings or other Patent Challenges that AbbVie, its Affiliate or
Sublicensee do not have the power to unilaterally withdraw or cause to be
withdrawn, AbbVie, its Affiliates and Sublicensees cease actively assisting any
other party to such Patent Challenge and, to the extent AbbVie, its Affiliate or
Sublicensee is a party to such Patent Challenge, it withdraws from such Patent
Challenge) within thirty (30) days after AbbVie’s receipt of notice regarding
such Patent Challenge, Infinity may terminate this Agreement by providing
written notice thereof to AbbVie.

 

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12.2.4. Termination for Insolvency. In the event that either Party (a) files for
protection under bankruptcy or insolvency laws, (b) makes an assignment for the
benefit of creditors, (c) appoints or suffers appointment of a receiver or
trustee over substantially all of its property that is not discharged within
ninety (90) days after such filing, (d) proposes a written agreement of
composition or extension of its debts, (e) proposes or is a party to any
dissolution or liquidation, (f) files a petition under any bankruptcy or
insolvency act or has any such petition filed against that is not discharged
within sixty (60) days of the filing thereof, or (g) admits in writing its
inability generally to meet its obligations as they fall due in the general
course, then the other Party may terminate this Agreement in its entirety
effective immediately upon written notice to such Party.

12.3. Effects of Termination. In the event of expiration or termination of this
Agreement, in its entirety or with respect to any country, for any reason, the
provisions of this Section 12.3 shall apply, with respect to the terminated
country or this Agreement in its entirety, as applicable.

12.3.1. Effects of Termination Generally. Promptly following the receipt of any
notice of termination in the entirety pursuant to Section 10.6.5(b), 12.2.1,
12.2.2, 12.2.3 or 12.2.4, Infinity shall prepare, with AbbVie’s reasonable
cooperation (as reasonably requested by Infinity), and the Parties shall
negotiate, a termination and wind-down plan that will include, at a minimum, a
plan for accomplishing the activities described in this Section 12.3
(“Termination and Wind-Down Plan”). Except as set forth in this ARTICLE 12, the
Parties acknowledge and agree that the Parties’ obligations under this Agreement
generally, including the GDP and all Commercialization Plans, shall terminate
conclusively and neither Party shall have any further rights or obligations
under this Agreement from and after the effective date of termination, except as
set forth in this Section 12.2.1; provided that if this Agreement is terminated
with respect to a particular country only, then such rights and obligations will
terminate only to the extent they relate solely to the terminated country. If
AbbVie has provided a notice of termination under Section 12.2.2(a), Infinity
may shorten the termination notice period under Section 12.2.2(a) in its
discretion.

12.3.2. Accrued Obligations. Expiration or termination of this Agreement for any
reason shall not release either Party from any obligation or liability which, on
the effective date of such expiration or termination, has already accrued to the
other Party or which is attributable to a period prior to such expiration or
termination; provided, that no milestone payment shall be due pursuant to
Section 7.1 if the event triggering such milestone payment occurs during the
period following a notice of termination but before the effective date of
termination.

12.3.3. Non-Exclusive Remedy. Notwithstanding anything herein to the contrary,
termination of this Agreement in whole or in part by a Party shall be without
prejudice to other remedies any Party may have at law or equity.

12.3.4. Survival. This Section 12.3.4, the provisions set forth in the following
Sections, as well as, to the extent applicable, any other Sections or defined
terms referred to in such Sections or Articles or necessary to give them effect,
shall survive any expiration or termination of this Agreement in its entirety:
Section 3.2.4 ([**]); Section 8.1 (Ownership of Inventions); Section

 

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8.1.2 ([**] Prosecution) (solely with respect to [**]), Section 8.3 (Third Party
Infringement) (solely with respect to [**]), Section 8.7.1 (Retained Rights in
Corporate Marks and Logos); Section 8.7.2(c) (Ownership); ARTICLE 9
(Confidentiality); ARTICLE 10 (Representations and Warranties); ARTICLE 11
(Indemnification); Section 12.3 (Effects of Termination); Section 14.4 (Choice
of Law); Section 14.5 (Notices); Section 14.12 (No Consequential or Punitive
Damages); Section 14.20 (Records Generally); ARTICLE 13 (Alternative Dispute
Resolution); and, to the extent that any obligations have accrued prior to
termination for any reason under this ARTICLE 12 or otherwise extend beyond the
effective date of termination (as expressly set forth therein), the payment
provisions in ARTICLE 7 (Financial Provisions). Furthermore, any other
provisions required to interpret the Parties’ rights and obligations under this
Agreement, including applicable definitions in ARTICLE 1, shall survive to the
extent required. Except as otherwise provided in this Section 12.3.4, all rights
and obligations of the Parties under this Agreement, including any licenses
granted hereunder, shall terminate upon expiration or termination of this
Agreement in its entirety or solely with respect to the terminated country, as
the case may be, for any reason.

12.3.5. Summary of Activities. Within [**] days after the notice of termination
of this Agreement is provided, AbbVie shall provide to Infinity a comprehensive
report of the status and results of its, and its Affiliates’ and Sublicensees’
activities under this Agreement, including its and its Affiliates’ and
Sublicensees’ Development, Manufacturing and Commercialization activities, if
any, with respect to Licensed Compounds and Products in the country(ies) or
territory where such termination has occurred, as applicable.

12.3.6. Regulatory Filings and Regulatory Approvals. At Infinity’s request,
AbbVie shall, promptly following the effectiveness of such termination, assign
and transfer to Infinity, all Regulatory Filings, filings for Pricing and
Reimbursement Approval and Marketing Authorizations for Products that are held
or controlled by or under authority of AbbVie or its Affiliates or Sublicensees
as of the effective date of termination, with respect to the terminated country
or the Territory, as the case may be, and shall take such actions and execute
such other instruments, assignments and documents as may be necessary to effect
the transfer of rights under such Regulatory Filings, filings for Pricing and
Reimbursement Approval and Marketing Authorizations to Infinity. If this
Agreement is terminated in its entirety, AbbVie shall also promptly transfer
control of and responsibility for maintaining the global safety database for
Products to Infinity (if previously held by AbbVie or its Affiliates), and
Infinity shall accept such transfer and responsibility. If applicable Law
prevents or delays the transfer of ownership of any such Regulatory Filing,
filing for Pricing and Reimbursement Approval or Marketing Authorizations to
Infinity, AbbVie shall grant, and does hereby grant, to Infinity an exclusive
and irrevocable right of access and Right of Reference to such Regulatory
Filing, filing for Pricing and Reimbursement Approval and Marketing
Authorizations for the Products in the Territory or the terminated country, as
the case may be, and shall reasonably cooperate to make the benefits of such
Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing
Authorizations available to Infinity or its designee(s). Infinity shall have the
right to grant licenses or sublicenses (as applicable) under the rights granted
to it under this Section 12.3.6 to its Affiliates and Third Parties, through
multiple tiers. For clarity, the rights and obligations in this Section 12.3.6
shall not apply to Regulatory Filings and Regulatory Approvals relating to or
involving AbbVie Combination Compounds.

 

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12.3.7. Technology Licenses.

(a) Upon the effectiveness of any termination of this Agreement, (i) all rights
and licenses granted by Infinity hereunder shall immediately terminate, in their
entirety or solely in the terminated country(ies), as applicable, and
(ii) AbbVie shall and hereby does grant to Infinity, effective upon the
effective date of any such termination, an exclusive, royalty-bearing,
perpetual, irrevocable license under the AbbVie Intellectual Property to
Develop, Manufacture and Commercialize Licensed Compounds and Products in the
Field in the Territory or the terminated country(ies), as applicable; provided
that: (i) the foregoing license shall exclude any license or other rights with
respect to any active ingredient that is not a Licensed Compound and which is
covered by Patents Controlled by AbbVie or any of its Affiliates, including, for
clarity, AbbVie Combination Compound; (ii) Infinity shall be responsible for
(A) making any payments (including royalties, milestones and other amounts)
payable by AbbVie to Third Parties under any Third Party agreements with respect
to the AbbVie Patents and AbbVie Know-How that are the subject of the license
granted by AbbVie to Infinity pursuant to this Section 12.3.6 and that arise out
of the Exploitation of the Products in the Territory of the terminated
country(ies), as applicable, by Infinity or its Affiliate or Sublicensees by
making such payments directly to AbbVie and, in each instance, Infinity shall
make the requisite payments to AbbVie and provide the necessary reporting
information to AbbVie in sufficient time to enable AbbVie to comply with its
obligations under such Third Party agreements, and (B) complying with any other
obligations included in any such Third Party agreements that are applicable to
the grant to AbbVie of such license or to the exercise of such license by
Infinity or any of its Affiliates or Sublicensees; and (iii) AbbVie shall be
responsible for paying or providing to any such Third Party any payments or
reports made or provided by Infinity under this Section 12.3.7. Infinity shall
have the right to grant sublicenses under the rights granted to it under this
Section 12.3.7 to its Affiliates and Third Parties, through multiple tiers,
except as may be limited by any applicable AbbVie Third Party Agreement.

(b) In consideration of the license under Section 12.3.7 and payments then made
to date by AbbVie under this Agreement, Infinity shall pay AbbVie a royalty on
Net Sales of each Product in each country of the Territory or the terminated
country(ies), as applicable, during the Post-Termination Royalty Term for such
Product in such country(ies) in the following circumstances and at the following
rates: (A) if this Agreement is terminated by AbbVie under Section 12.2.1(a) for
Infinity’s material breach, the royalty rate will be (x) [**] percent ([**]%) of
Net Sales [**] but such royalties will be paid only until the cumulative royalty
payments under this Section 12.3.7 equal [**] (B) if this Agreement is
terminated by Infinity under Section 12.2.1(a) (in its entirety or with respect
to a particular country(ies)) for AbbVie’s material breach, the royalty rate
will be [**] percent ([**]%) of Net Sales. For purposes of this Section 12.3.6,
the definition of “Net Sales” and the terms of ARTICLE 7 shall apply mutatis
mutandis to the calculation (including royalty reduction), payment, recording,
and auditing of Infinity’s obligations to pay royalties under this Section. For
purposes of this Section, “Post-Termination Royalty Term” means, with respect to
each Product and each country or other jurisdiction in the Territory or
terminated country(ies), as applicable, the period beginning on the date of the
First Sale of such Product in such country or other jurisdiction after
termination of this Agreement and ending on [**].

12.3.8. Survival of Sublicenses. In the event of a termination of this Agreement
while a sublicense of rights granted by AbbVie with respect to the terminated
country is in effect, the terms of this Section 12.3.8 shall apply, provided,
that the applicable Sublicensee is not in material breach of the applicable
sublicense agreement. In such event, (i) all of such Sublicensee’s obligations
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obligations to Infinity and shall be enforceable solely by Infinity as a third
party beneficiary, (ii) such Sublicensee’s rights under the sublicense agreement
that do not exceed and are not inconsistent with Infinity’s obligations to
AbbVie under this Agreement, whether in scope, duration, nature or otherwise,
shall survive termination; provided, that the foregoing shall in no way be
interpreted to increase the scope, duration, territory or other aspect of the
rights sublicensed to such Sublicensee and (iii) all of AbbVie’s rights under
the sublicense agreement shall remain in effect, may be exercised solely by
Infinity and shall inure to the exclusive benefit of Infinity.

12.3.9. Marks and Domains. Effective upon the effective date of termination,
AbbVie hereby assigns and shall cause to be assigned to Infinity all rights in
and to any Product Trademarks in the terminated country(ies) or worldwide, as
applicable, and all Internet domain names for the terminated country
incorporating any Product Trademark as its URL address or any part of such
address. It is understood that such assignment shall not include the name of
AbbVie or any of its Affiliates, nor the corporate logo, service mark, or
trademark for AbbVie or for any of its Affiliates as a corporate entity.

12.3.10. Governance during Wind-Down. Beginning on the date of notice of
termination of this Agreement in its entirety and until such termination becomes
effective, Section 2.9 and ARTICLE 13 shall no longer apply with respect to any
decisions of any Committee or Working Group with respect to the terminated
country or this Agreement in its entirety, as applicable, and Infinity shall
have the right to cast a deciding vote with respect to any matter to be decided
by any Committee or Working Groups, which deciding vote shall be deemed the
decision of such Committee or Working Group; provided, however, that Infinity
may not cast such a deciding vote (a) to impose additional responsibilities on
AbbVie under the GDP or a Commercialization Plan of a materially different
nature or magnitude than AbbVie’s responsibilities thereunder prior to
termination, or (b) to increase the budget included within the Development
Budget or any Commercialization Budget, as last approved by the JSC.

12.3.11. Post-Termination Shared Product Liability Costs. In the event that
Infinity terminates this Agreement in its entirety pursuant to Section 12.2.1
(Termination for Material Breach) or AbbVie terminates this Agreement pursuant
to Section 12.2.2 (Termination by AbbVie Unilaterally), a Party or any of its
Affiliates incurs any Shared Product Liability Costs after the Term, which
Shared Product Liability Costs are attributable to sales or other activities
under this Agreement during the Term (or with respect to the terminated country
prior to termination with respect to such country only), each Party shall be
responsible for fifty percent (50%) of such Shared Product Liability Costs. Each
Party will promptly pay the other Party its share of any such Shared Product
Liability Costs after receipt of detailed supporting documentation evidencing
such Shared Product Liability Costs.

12.3.12. On-Going Trials. In the event that any Clinical Study with respect to a
AbbVie Combination Compound has been Commenced and is on-going as of the
effective date of any termination of this Agreement by Infinity in its entirety
pursuant to Section 12.1 (Termination for Material Breach) or by AbbVie pursuant
to Section 12.2.2 (Termination by AbbVie Unilaterally), AbbVie shall continue to
fund fifty percent (50%) of the Combination Study Costs of such Clinical Study
and conduct such Clinical Study. In addition, if there are any Clinical Studies
being conducted by or under the authority of AbbVie or any of its Affiliates at
the time of notice of termination (other than Combination Clinical Studies),
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been Commenced and is on-going as of the effective date of the termination of
this Agreement in its entirety (an “On-Going Clinical Study”), AbbVie shall, as
Infinity may request, (a) promptly transition to Infinity or its designee some
or all of such On-Going Clinical Studies and the activities related to or
supporting such trials, (b) unless this Agreement has been terminated by AbbVie
pursuant to Section 12.2.1 (Termination for Material Breach), continue to
conduct such On-Going Clinical Studies for a period requested by Infinity up to
a maximum of [**] after the effective date of such termination, or (c) terminate
such On-Going Clinical Studies in a manner consistent with applicable Laws;
provided, however, that in the event that Infinity, AbbVie, an institutional
review board or independent safety board determines that an On-Going Clinical
Study being run by AbbVie or any of its Affiliates would pose an unacceptable
safety risk for subjects or patients participating in such On-Going Clinical
Study, then AbbVie shall not be obligated to continue such Clinical Study and
AbbVie shall provide Infinity with a full explanation of the safety issue
concerns raised by such institutional review board or independent safety board
and, if requested by Infinity, reasonable documentation thereof and such
additional information as may be necessary to permit Infinity to fully
understand and assess such safety issues.

12.3.13. Commercialization Wind-Down. This Section 12.3.13 shall apply unless
this Agreement is terminated by AbbVie pursuant to Section 12.2.1: To the extent
requested by Infinity, AbbVie and its Affiliates and Sublicensees shall
reasonably cooperate with Infinity and its designees to facilitate a smooth,
orderly and prompt transition to Infinity or its designees of Commercialization
activities of Products already commercially sold by AbbVie in such countries in
which AbbVie was distributing and selling Products as of the effective date of
termination in the terminated country (or anywhere in the Territory, if this
Agreement is terminated in its entirety) (the “Launched Products”), in
accordance with the terms and conditions of this Agreement and as set forth in
the applicable, then-current Commercialization Plan, for a period requested by
Infinity, not to exceed [**] from the effective date of such expiration or
termination (the “Agreement Wind-Down Period”); provided, that Infinity may
terminate such activities during the Agreement Wind-Down Period upon [**] days’
notice to AbbVie. If Infinity requests that AbbVie and its Affiliates and
Sublicensees distribute and sell the Launched Products during the Agreement
Wind-Down Period, Infinity shall grant, and hereby grants, to AbbVie for the
duration of the Agreement Wind-Down Period (or, if earlier, until Infinity
terminates such by notice as described in the preceding sentence), a
non-exclusive license under the Infinity Intellectual Property to Commercialize
and have Commercialized the Launched Products in the applicable countries in the
ex-US Territory, solely to perform such distribution and sale with respect to
Launched Products in countries requested by Infinity. If Infinity requests that
AbbVie and its Affiliates and Sublicensees distribute and sell the Launched
Products during the Agreement Wind-Down Period, Infinity shall not purchase
existing inventory of AbbVie pursuant to Section 12.3.15 in an amount that would
prevent AbbVie from continuing such distribution and sales. For clarity,
following the effective date of termination of this Agreement in its entirety,
the Parties’ obligations under Section 3.7 shall terminate, and Infinity shall
have the right to engage one or more other partners or distributors of Products
in all or part of the Territory during the Agreement Wind-Down Period. Any
Products sold or disposed by AbbVie or its Affiliates or Sublicensees during the
Agreement Wind-Down Period shall be subject to the applicable payments under the
Financial Exhibit. After the Agreement Wind-Down Period, AbbVie and its
Affiliates and Sublicensees shall no longer have a right to sell Products
hereunder.

 

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12.3.14. Customer Information. AbbVie shall, and shall ensure that its
Affiliates and Sublicensees, transfer and assign to, and hereby does assign to
Infinity or its designee(s) all promotional materials, customer data,
competitive intelligence data, market research and other materials, information
or data related to the marketing, promotion or sale of Licensed Compounds or
Products in the Territory or the terminated country, as applicable,
(“Marketing-Related Materials”) in their possession or control as of the
effective date of such termination, to the extent necessary or reasonably useful
for the Commercialization of Licensed Compounds or Products in the Territory or
terminated country, as applicable.

12.3.15. Return of Confidential Information. Within [**] days after the
effective date of termination of this Agreement in its entirety, or earlier if
requested by a Party, each Party shall, and cause its Affiliates to (a) destroy,
all tangible items solely comprising, bearing or containing any Confidential
Information of the other Party that are in such first Party’s or its Affiliates’
possession or control, and provide written certification of such destruction, or
(b) prepare such tangible items of the other Party’s Confidential Information
for shipment to such other Party, as such other Party may direct, at the first
Party’s expense; provided, that, in any event, (x) each Party may retain one
copy of the Confidential Information of the other Party to the extent necessary
to perform its obligations that survive expiration or termination of this
Agreement; (y) such first Party may retain one copy of such Confidential
Information of the other Party for its legal archives; and (z) Infinity may
retain AbbVie’s Confidential Information to the extent necessary for Infinity to
exercise its rights that survive expiration or termination of this Agreement.

12.3.16. Transition; Manufacturing; Inventory. AbbVie and its Affiliates shall
reasonably cooperate with Infinity and its designees to facilitate a smooth,
orderly and prompt transition to Infinity or its designees of the activities
with respect to Licensed Compounds and Products, including any ongoing
Development, Manufacturing and Commercialization of Licensed Compounds and
Products, for a period requested by Infinity (not to exceed [**] after the
Term). Except as expressly stated in this ARTICLE 12, all out-of-pocket costs
incurred by the Parties in connection with transition activities conducted under
this ARTICLE 12 shall be borne by the AbbVie. If AbbVie or its Affiliate
Manufactured or had Manufactured any Licensed Compound or Product at the time of
termination, then AbbVie (or its Affiliate) shall continue to provide for
Manufacturing of such Licensed Compound or Product for Infinity, at [**]
therefor, from the effective date of such termination until such time as
Infinity is able, using Diligent Efforts to do so, to secure an acceptable
alternative manufacturing source from which sufficient quantities of such
Licensed Compound or Product may be procured and legally sold throughout the
Territory, but in any event no longer than [**] months after the effective date
of termination. If a Sublicensee Manufactures a Licensed Compound or Product on
AbbVie’s or its Affiliate’s behalf at the time of termination, upon request of
Infinity, AbbVie shall use Diligent Efforts to transfer the applicable
Sublicense to Infinity on or promptly after the effective date of termination.
Upon the expiration of such period or the expiration or termination of this
Agreement, Infinity shall have the right to purchase from AbbVie, and AbbVie
shall sell to Infinity if requested by Infinity, all of AbbVie’s and its
Affiliate’s existing inventory of Licensed Compounds and Products at a price
equal to [**] for such Licensed Compounds and Products (taking into account the
Supply Price for any portion of such inventory previously shared by AbbVie under
this Agreement).

 

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12.3.17. Cooperation. Each Party shall cause its Affiliates and Sublicensees to
comply with the obligations in this Section 12.3.

12.3.18. Cross Termination. The Supply Agreements shall terminate upon
termination of this Agreement, with the relevant sections therein stated to
survive termination so surviving.

ARTICLE 13.

ALTERNATIVE DISPUTE RESOLUTION

13.1. Alternative Dispute Resolution. Except for the Excluded Matters and the
Excluded Claims (including those matters described in the final sentence of
Section 2.9.2), any dispute, claim or controversy arising from or related in any
way to this Agreement or the interpretation, application, breach, termination or
validity thereof (a “Dispute”), in each case which, if it is a dispute within
the scope of Section 2.9 (other than an Excluded Matter), has been referred to
the Executive Officers for resolution in accordance with Section 2.9 and has not
been resolved within the time specified in Section 2.9, will be resolved by
alternative dispute resolution (“ADR”) as follows:

13.1.1. The place of arbitration shall be New York, New York, and all
proceedings and communications shall be in English.

13.1.2. To begin an ADR proceeding, a Party shall provide written notice to the
other Party of the Dispute to be resolved by ADR. Within [**] days after its
receipt of such notice, the other Party may, by written notice to the Party
initiating the ADR, add additional issues to be resolved within the same ADR.
Thereafter, no new issues can be added absent consent of the tribunal, which
consent shall be granted for good cause. In assessing whether good cause exists
for permitting the addition of new issues, the tribunal shall consider all
relevant factors, including whether justice is served by allowing the addition
of new issues, whether a Party unduly delayed in seeking to add a new issue, and
whether the other Party would be unfairly prejudiced by the addition of the new
issues. The ADR shall be administered by Judicial Arbitration and Mediation
Services, Inc. (“JAMS”) pursuant to the then-current JAMS Comprehensive Rules
and Procedures, except as modified under this Section 13.1.

13.1.3. Within [**] days following the initiation of the ADR proceeding, the
Parties shall select a mutually acceptable independent, impartial and
conflicts-free neutral from the JAMS list of neutrals to preside in the
resolution of all issues in this ADR proceeding. If the Parties are unable to
agree on a mutually acceptable neutral (who does not need to be from the JAMS
list) within such period, each Party will select one (1) independent, impartial
and conflicts-free neutral and, within [**] days thereafter, those two neutrals
will select a third independent, impartial and conflicts-free neutral from the
JAMS list of neutrals to preside as the chair of the panel of such three
neutrals (such neutral(s), the “Neutral”). None of the neutrals selected may be
current or former employees, officers or directors of either Party or its
Affiliates. Furthermore, the following provisions shall supplement (but not
replace) the provisions of the JAMS Comprehensive Rules and Procedures regarding
neutrality:

 

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(a) A person shall be deemed to have a conflict, and shall not be appointed as a
Neutral absent the consent of both parties, if such person (i) has presided over
an evidentiary hearing relating to, or issued a ruling on, the merits of a
dispute, involving either Party; (ii) has conducted a mediation involving either
Party, or (iii) has been retained to perform and has performed professional
services for either Party within the last 10 years. The “merits of a dispute”
are matters substantially related to the substance of the underlying claim, and
do not include procedural or discovery-related matters;

(b) A person shall be deemed to have a conflict, and shall not be appointed as a
Neutral absent consent of both parties, if such person previously served as a
party-appointed arbitrator appointed by either Party, or by any party
represented in a previous arbitration by one of the law firms representing
either Party in any Dispute referred to ADR under this Agreement, if the
governing rules of such arbitration did not require such arbitrator to be
impartial and independent; and

(c) Neither Party nor any person acting on behalf of a Party may have any ex
parte communications with any Neutral at any time before or during the
proceedings. Notwithstanding JAMS Comprehensive Rules and Procedures, prohibited
ex parte communications shall include, advising the candidate of the general
nature of the controversy and of the anticipated proceedings and to discuss the
candidate’s qualifications, availability or independence in relation to the
Parties.

13.1.4. No earlier than [**] days or later than [**] days after selection, the
Neutral shall hold a hearing to resolve each of the issues identified by the
Parties. The ADR proceeding shall take place at a location in New York, New York
to be agreed upon by the Parties. If the Parties cannot agree, the Neutral shall
designate a location other than the principal place of business of either Party
or any of their Affiliates.

13.1.5. At least [**] days prior to the hearing, each Party shall submit the
following to the other Party and the Neutral:

(a) a copy of all exhibits on which such Party intends to rely in any oral or
written presentation to the Neutral;

(b) a list of any witnesses such Party intends to call at the hearing, and a
short summary of the anticipated testimony of each witness;

(c) a proposed ruling on each issue to be resolved, together with a request for
a specific damage award or other remedy for each issue. The proposed ruling
shall not contain any recitation of the facts or any legal arguments, and the
proposed remedy shall not include any punitive damages. The proposed ruling and
the proposed remedy collectively shall not exceed [**]; and

(d) a brief in support of such Party’s proposed rulings and remedies; provided,
that the brief shall not exceed [**] pages. This page limitation shall apply
regardless of the number of issues raised in the ADR proceeding.

 

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13.2. Each Party shall be entitled to [**]. The Neutral can permit additional
discovery, subject to the limits specified below, where such discovery is
reasonably calculated to lead to admissible evidence regarding liability or
damages, and with respect to a request for an additional deposition, the
necessity of an additional deposition shall be determined by the Neutral based
upon the reasonable need for the requested information, the availability of
other discovery options and the burdensomeness of the request on the opposing
Parties and the witness. For such additional discovery, in no event shall a
Party be permitted more than [**]. Within [**] days of the [**] within [**])
days thereafter and, [**]. The hearing shall be conducted on no more than [**]
consecutive days and shall be governed by the following rules:

13.2.1. Each Party shall be entitled to [**] hours of hearing time to present
its case. The Neutral shall determine whether each Party has had the [**] hours
to which it is entitled.

13.2.2. Each Party shall be entitled, but not required, to make an opening
statement, to present regular and rebuttal testimony, documents, or other
evidence, to cross-examine witnesses, and to make a closing argument.
Cross-examination of witnesses shall occur immediately after their direct
testimony, and cross-examination time shall be charged against the Party
conducting the cross-examination.

13.2.3. The Party initiating the ADR shall begin the hearing and, if it chooses
to make an opening statement, shall address therein not only issues it raised
but also any issues raised by the responding Party. The responding Party, if it
chooses to make an opening statement, also shall address all issues raised in
the ADR. Thereafter, the presentation of regular and rebuttal testimony and
documents, other evidence, and closing arguments shall proceed in the same
sequence.

13.2.4. Except when testifying, witnesses shall be excluded from the hearing
until closing arguments.

13.2.5. Settlement negotiations, including any statements made therein, shall
not be admissible under any circumstances. Affidavits prepared for purposes of
the ADR hearing also shall not be admissible. As to all other matters, the
Neutral shall have sole discretion regarding the admissibility of any evidence.

13.3. Prior to the completion of the hearing, a Party may seek leave from the
Neutral to modify its proposed rulings on one or more issues to be resolved. If
the Neutral finds good cause for such modification, within [**] days following
completion of the hearing, the Parties shall file a substitute proposed ruling
on each issue for which the Neutral allows a modification, together with a
request for a specific damage award or other remedy for each such issue. The
proposed ruling shall not contain any recitation of the facts or any legal
arguments, and the proposed remedy shall not include any punitive damages. The
proposed ruling and the proposed remedy collectively shall not exceed [**].

13.4. Within [**] days following completion of the hearing, each Party may
submit to the other Party and the Neutral a post-hearing brief in support of its
proposed rulings and remedies; provided, that such brief shall not contain or
discuss any new evidence and shall not exceed [**]. This page limitation shall
apply [**].

 

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13.5. The Neutral shall rule on each disputed issue within [**] days following
completion of the hearing. Such ruling shall adopt in its entirety the proposed
ruling and remedy of one (1) of the Parties on each disputed issue but may adopt
one (1) Party’s proposed rulings and remedies on some issues and the other
Party’s proposed rulings and remedies on other issues. The Neutral shall not
issue any written opinion or otherwise explain the basis of the ruling.

13.6. The Neutral shall be paid a reasonable fee plus expenses. These fees and
expenses, along with the reasonable legal fees and expenses of the prevailing
Party (including all expert witness fees and expenses), the fees and expenses of
a court reporter, and any expenses for a hearing room, shall be paid as follows:

13.6.1 If the Neutral rules in favor of one (1) Party on all disputed issues in
the ADR, the losing Party shall pay [**] percent ([**]%) of such fees and
expenses.

13.6.2 If the Neutral rules in favor of one (1) Party on some issues and the
other Party on other issues, [**].

13.7. The rulings of the Neutral and the allocation of fees and expenses shall
be binding, non-reviewable, and non-appealable, and may be entered as a final
judgment in any court having jurisdiction.

13.8. Except as provided in Section 13.7 or as required by law, the existence of
the Dispute, any settlement negotiations, the ADR proceeding, any submissions
(including exhibits, testimony, proposed rulings, and briefs), and the rulings
shall be deemed to be Confidential Information of both Parties. The Neutral
shall have the authority to impose sanctions for unauthorized disclosure of
Confidential Information.

13.9. Each Party shall have the right to be represented by counsel in all
aspects of any ADR proceeding.

13.10. All proceedings and communications shall be in English.

13.11. Jury Waiver. EACH PARTY WAIVES ITS RIGHT TO TRIAL BY JURY OF ANY ISSUE
WITHIN THE SCOPE OF THE AGREEMENT TO ARBITRATE AS SET FORTH IN SECTION 13.1.

13.12. Enforcement. The arbitrators’ award(s) shall be enforceable in any United
States District Court of competent jurisdiction.

13.13. Expert Panel Arbitration.

13.13.1 . Any Dispute arising from the JSC and remaining unresolved after
escalation to the Executive Officers pursuant to Section 2.9.2 and pertaining to
[**].

13.13.2 . Any dispute to be resolved pursuant to this Section 13.13.2 will take
place pursuant to the following procedures: Promptly following receipt of any
notice requiring dispute resolution pursuant to this Section 13.13.2, the
Parties shall meet and discuss in good faith and agree on an expert panel to
resolve the issue, which expert panel shall be neutral and independent

 

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of both Parties and all of their respective Affiliates, shall have significant
experience and expertise in the substantive area in question, and shall have
some experience in mediating or arbitrating issues relating to such agreements.
If the Parties cannot agree on such expert panel within [**] days of request by
a Party for arbitration, then each Party shall select one (1) expert for such
panel and the two (2) experts selected by the Parties shall select a third
expert for the panel, provided, that all such three (3) experts must meet the
foregoing criteria. Within [**] days after a panel is selected (or appointed, as
the case may be), each Party will deliver to both the expert panel and the other
Party a detailed written proposal setting forth its proposed terms for the
resolution for the matter at issue (the “Proposed Terms” of the Party) and a
memorandum (the “Support Memorandum”) in support thereof, not exceeding [**]
pages in length. The Parties will also provide the expert panel a copy of this
Agreement, as may be amended at such time. Within [**] days after receipt of the
other Party’s Proposed Terms and Support Memorandum, each Party may submit to
the expert panel (with a copy to the other Party) a response to the other
Party’s Support Memorandum, such response not exceeding [**] pages in length.
Neither Party may have any other communications (either written or oral) with
the expert panel other than for the sole purpose of engaging the expert panel or
as expressly permitted in this Section 13.13.2; provided, that the expert panel
may convene a hearing if the expert panel so chooses to ask questions of the
Parties and hear oral argument and discussion regarding each Party’s Proposed
Terms. Within [**] days after the expert panel’s appointment, the expert panel
will select one of the two Proposed Terms (without modification) provided by the
Parties that the expert panel believes is most consistent with the intention
underlying and agreed principles set forth in this Agreement. The decision of
the expert panel shall be final, binding, and unappealable. The expert panel
must select as the only method to resolve the matter at issue one of the two
sets of Proposed Terms, and may not combine elements of both Proposed Terms or
award any other relief or take any other action.

ARTICLE 14.

MISCELLANEOUS

14.1. Change of Control of the Parties.

14.1.1. Each Party (or its successor) shall provide the other Party with written
notice of any Acquisition Transaction of such Party within [**] Business Days
following the [**]; provided, that any failure to so provide such notice shall
not be deemed a material breach of this Agreement.

14.2. Assignment; Successors.

14.2.1. This Agreement and the rights and obligations of each Party hereunder
shall not be assignable, delegable, transferable, pledged or otherwise disposed
of by either Party without the prior written consent of the other Party, such
consent not to be unreasonably withheld, conditioned, or delayed; provided,
however, that (a) either Party may assign or transfer this Agreement, without
such consent (but with written notice to the other Party), (i) to an Affiliate
(but only for so long as such Person remains an Affiliate of such Party, it
being agreed that such Party shall cause such assignment or transfer to
terminate prior to such time, if any, as such Person ceases to be an Affiliate
of such Party), or (ii) to a Third Party that acquires all or substantially all
of the business or assets of such Party, whether by merger, reorganization,
acquisition, sale or otherwise, including if such Party undergoes a Change of
Control, and (b) this Section 14.2.1 shall not apply to

 

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sublicensing or subcontracting rights or obligations under this Agreement, which
shall be conducted in accordance with this Agreement. If this Agreement is
assigned or transferred to an Affiliate, the assigning or transferring Party
shall remain responsible (jointly and severally) with such Affiliate for the
performance of such assigned or transferred obligations. No assignment or
transfer of this Agreement or a Party’s rights or obligations hereunder shall be
valid and effective unless and until the assignee agrees in writing to be bound
by the terms and conditions of this Agreement.

14.2.2. Notwithstanding anything to the contrary in ARTICLE 3 or in any other
provision of this Agreement, the rights to compounds, products, materials and
intellectual property (including Patent Rights and Know-How): (a) Controlled by
a Third Party permitted assignee of a Party, which information, materials and
intellectual property were Controlled by such assignee immediately prior to such
assignment; or (b) Controlled by an Affiliate of a Party who becomes an
Affiliate through any Acquisition Transaction by or of such Party, which
compounds, products, materials and intellectual property were Controlled by such
Affiliate immediately prior to such Acquisition Transaction or, or (c) in the
case of (a) or (b) by such Third Party permitted assignee or Affiliate after
such Third Party permitted assignee or Affiliate became such without reference
to or use of any intellectual property rights of a Party, in each case ((a),
(b) and (c)), shall be automatically excluded from the rights licensed or
granted to the other Party under this Agreement.

14.2.3. Any permitted assignment of the rights and obligations of a Party under
this Agreement shall be binding on, and inure to the benefit of and be
enforceable by and against, the successors and permitted assigns of the
assigning Party. The permitted assignee or transferee shall assume all
obligations of its assignor or transferor under this Agreement. Without limiting
the foregoing, the grant of rights set forth in this Agreement shall be binding
upon any successor or permitted assignee of Infinity, and the obligations of
AbbVie, including the payment obligations, shall run in favor of any such
successor or permitted assignee of Infinity’s benefits under this Agreement. Any
assignment or attempted assignment by either Party in violation of the terms of
this Section 14.2.3 shall be null, void and of no legal effect.

14.3. Export Control. This Agreement is made subject to any restrictions
concerning the export of products or technical information from the United
States or other countries that may be imposed on the Parties from time to time.
Each Party agrees that it will not export, directly or indirectly, any technical
information acquired from the other Party under this Agreement or any products
using such technical information to a location or in a manner that at the time
of export requires an export license or other governmental approval, without
first obtaining the written consent to do so from the appropriate agency or
other governmental entity in accordance with applicable Law.

14.4. Choice of Law. This Agreement shall be governed by and interpreted under
the laws of the State of Delaware, other than any principle of conflict or
choice of laws that would cause the application of the laws of any other
jurisdiction; provided, that all questions concerning (a) inventorship of
Patents under this Agreement shall be determined in accordance with
Section 8.1.3 and (b) the construction or effect of Patents shall be determined
in accordance with the laws of the country or other jurisdiction in which the
particular Patent has been filed or granted, as the case may be. The Parties
agree to exclude the application to this Agreement of (a) the United Nations
Conventions on Contracts for the International Sale of Goods; (b) the 1974
Convention on the Limitation Period in the International Sale of Goods (the
“1974 Convention”); and (c) the Protocol amending the 1974 Convention, done at
Vienna April 11, 1980.

 

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14.5. Notices. Any notice or report required or permitted to be given or made
under this Agreement by one Party to the other shall be in writing and shall be
deemed to have been delivered (a) upon personal delivery, (b) on the second
Business Day (at the place of delivery) next following deposit with a reputable,
internationally recognized overnight courier that maintains records of delivery
and (c) in the case of notices provided by telecopy (which notice shall be
followed immediately by an additional notice pursuant to clause (b) or (c) above
if the notice is of a default hereunder), upon completion of transmission, with
transmission confirmed, to the addressee’s facsimile machine, as follows (or at
such other addresses or facsimile numbers as may have been furnished in writing
by a Party to the other as provided in this Section 14.5). This Section 14.5 is
not intended to govern the day-to-day business communications necessary between
the Parties in performing their obligations under the terms of this Agreement.

 

If to Infinity:    Infinity Pharmaceuticals, Inc.    780 Memorial Drive   
Cambridge, Massachusetts 02139    Attn: Chief Executive Officer    Fax:
1-617-453-1001 With a copy to:    Infinity Pharmaceuticals, Inc.    780 Memorial
Drive    Cambridge, Massachusetts 02139    Attn: General Counsel    Fax:
1-617-453-1001 If to AbbVie:   

AbbVie Inc.

1 North Waukegan Road

North Chicago, Illinois 60064

Attn: Executive Vice President, Business

Development, External Affairs and General Counsel

Fax: 1-847- 935-3294

With a copy to:   

Ropes & Gray LLP

800 Boylston Street

Prudential Tower

Boston, Massachusetts 02199-3600

Attn: Marc Rubenstein

Fax: 1-617-235-0706

14.6. Severability. If, under applicable Law, any provision of this Agreement is
invalid or unenforceable, or otherwise directly or indirectly affects the
validity of any other material provision of this Agreement and if the rights or
obligations of either Party under this Agreement will not be materially and
adversely affected thereby, (such invalid or unenforceable provision, a “Severed
Clause”), it is mutually agreed that (a) this Agreement shall endure except for
the Severed Clause, (b) this Agreement shall be construed and enforced as if
such Severed Clause had

 

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never comprised a part hereof, (c) the remaining provisions of this Agreement
shall remain in full force and effect and shall not be affected by the Severed
Clause or by its severance herefrom, and (d) in lieu of such illegal, invalid,
or unenforceable provision, there shall be added automatically as a part of this
Agreement a legal, valid, and enforceable provision as similar in terms to such
illegal, invalid, or unenforceable provision as may be possible and reasonably
acceptable to the Parties. To the fullest extent permitted by applicable Law,
each Party hereby waives any provision of law that would render any provision
hereof illegal, invalid, or unenforceable in any respect.

14.7. Integration. This Agreement (and, when executed, each Related Agreement),
together with all schedules and exhibits attached hereto, constitutes the entire
agreement between the Parties with respect to the subject matter of this
Agreement and supersedes all previous agreements, whether written or oral,
including the Prior CDA. In the event of a conflict between the GDP, any
Commercialization Plan or any schedules or attachments to this Agreement, on the
one hand, and this Agreement, on the other hand, the terms of this Agreement
shall govern. Each Party confirms that it is not relying on any representations
or warranties of the other Party except as specifically set forth in this
Agreement.

14.8. English Language. This Agreement shall be written and executed in, and all
other communications under or in connection with this Agreement shall be in, the
English language. Any translation into any other language shall not be an
official version thereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version shall
control.

14.9. Waivers and Amendments. The failure of any Party to assert a right
hereunder or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or condition by the other Party.
Notwithstanding the authority granted to any Committee or Working Group under
this Agreement, (a) no waiver shall be effective unless it has been given in
writing and signed by the Party giving such waiver, and (b) no provision of this
Agreement may be amended or modified other than by a written document signed by
authorized representatives of each Party.

14.10. Independent Contractors; No Agency. Neither Party shall have any
responsibility for the hiring, firing or compensation of the other Party’s or
such other Party’s Affiliates’ employees or for any employee benefits with
respect thereto. No employee or representative of a Party or its Affiliates
shall have any authority to bind or obligate the other Party for any sum or in
any manner whatsoever, or to create or impose any contractual or other liability
on such other Party, without such other Party’s written approval. For all
purposes, and notwithstanding any other provision of this Agreement to the
contrary, each Party’s legal relationship under this Agreement to the other
Party shall be that of independent contractor, and the relationship between the
two (2) Parties shall not constitute a partnership, joint venture, or agency,
including for all tax purposes.

14.11. Execution in Counterparts; Facsimile Signatures. This Agreement may be
executed in counterparts, each of which counterparts, when so executed and
delivered, shall be deemed to be an original, and all of which counterparts,
taken together, shall constitute one and the same instrument even if both
Parties have not executed the same counterpart. Signatures provided by facsimile
transmission or in Adobe™ Portable Document Format (PDF) sent by electronic mail
shall be deemed to be original signatures.

 

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14.12. No Consequential or Punitive Damages.

14.12.1. EXCEPT AS SET FORTH IN SECTION 14.12.2, NEITHER PARTY NOR ANY OF ITS
AFFILIATES WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL,
EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE
EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR ANY LOSS OR INJURY TO A PARTY’S OR ITS
AFFILIATES’ PROFITS, BUSINESS (INCLUDING BUSINESS INTERRUPTION) OR GOODWILL
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, IN EACH CASE HOWEVER
CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE,
BREACH OF STATUTORY DUTY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.

14.12.2. THE LIMITATIONS AND DISCLAIMER SET FORTH IN SECTION 14.12.1 SHALL NOT
APPLY TO A CLAIM (I) FOR WILLFUL MISCONDUCT; (II) BY INFINITY AGAINST ABBVIE FOR
DAMAGES RESULTING FROM A BREACH OF SECTION 3.7.2; (III) BY ABBVIE AGAINST
INFINITY FOR DAMAGES RESULTING FROM AN INTENTIONAL AND WILLFUL BREACH OF
SECTIONS 3.7.1; OR (IV) FOR DAMAGES RESULTING FROM A BREACH OF ARTICLE 9.

14.12.3. NOTHING IN THIS SECTION 14.12 IS INTENDED TO LIMIT OR RESTRICT THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD
PARTY CLAIMS.

14.13. Performance by Affiliates. To the extent that this Agreement imposes
obligations on Affiliates or Sublicensees of a Party, such Party shall cause its
Affiliates and shall use Diligent Efforts to cause its Sublicensees to perform
such obligations. Either Party may use one or more of its Affiliates to perform
its obligations and duties hereunder; provided, that each such Affiliate or
Sublicensee shall be bound by the corresponding obligations of the applicable
Party and provided, further, that, subject to such Party’s assignment to an
Affiliate pursuant to Section 14.2, such Party shall remain liable hereunder for
the prompt payment and performance of all of its obligations hereunder.

14.14. Force Majeure. Neither Party shall be responsible to the other for, or be
deemed to have defaulted under or breached this Agreement for, any failure or
delay in performing any of its obligations under this Agreement or for other
nonperformance hereunder (excluding, in each case, the obligation to make
payments when due) if such delay or nonperformance is caused by or results from
events beyond the reasonable control of the non-performing Party, including
strike, fire, flood, earthquake, hurricanes, accident, war, acts of war (whether
war be declared or not), insurrections, riots, civil commotion, strikes,
lockouts, or other labor disturbances (whether involving the workforce of the
non-performing Party or of any other Person), act of terrorism, act of God or
acts, omissions or delays in acting of the government of any country or of any
local government, or by cause unavoidable or beyond the reasonable control of
such Party (except to the extent such delay results from the breach by the
non-performing Party or any of its Affiliates of

 

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any term or condition of this Agreement). In such event, the Party affected will
promptly (and, in any event, within thirty (30) days) notify the other Party in
writing of such force majeure event, stating the nature of the event, its
anticipated duration, and any action being taken to avoid or minimize its
effect. The suspension of performance shall be of no greater scope and no longer
duration than is necessary and the non-performing Party and shall use Diligent
Efforts to resume performance of its obligations.

14.15. No Third Party Beneficiary Rights. This Agreement is not intended to and
shall not be construed to give any Third Party any interest or rights (including
any third party beneficiary rights) with respect to or in connection with any
agreement or provision contained herein or contemplated hereby, other than, to
the extent provided in ARTICLE 11, the Indemnified Parties (including Persons
entitled to indemnification under ARTICLE 11 with respect to Product Liability
Actions).

14.16. Non-exclusive Remedy. Except as expressly provided herein, the rights and
remedies provided herein are cumulative and each Party retains all remedies at
law or in equity, including the Parties’ ability to receive legal damages or
equitable relief, with respect to any breach of this Agreement. Neither Party
shall be required to terminate this Agreement due to a breach of this Agreement
by the other Party.

14.17. Interpretation. The Article and Section headings used herein are for
reference and convenience only, and will not enter into the interpretation of
this Agreement. Except as otherwise explicitly specified to the contrary,
(a) references to an Article, Section, Exhibit or Schedule means an Article or
Section of, or a Schedule or Exhibit to this Agreement and all subsections
thereof, unless another agreement is specified; (b) references in any Section to
any clause are references to such clause of such Section; (c) references to any
agreement, instrument, or other document in this Agreement refer to such
agreement, instrument, or other document as originally executed or, if
subsequently amended, replaced, or supplemented from time to time, as so
amended, replaced, or supplemented and in effect at the relevant time of
reference thereto; (d) references to a particular Law mean such Law as in effect
as of the relevant time, including all rules and regulations thereunder and any
successor Law in effect as of the relevant time, and including the then-current
amendments thereto; (e) words in the singular or plural form include the plural
and singular form, respectively; (f) unless the context requires a different
interpretation, the word “or” has the inclusive meaning that is typically
associated with the phrase “and/or”; (g) the terms “including,” “include(s),”
“such as,” “e.g.” and “for example” mean including the generality of any
description preceding such term and will be deemed to be followed by “without
limitation”; (h) whenever this Agreement refers to a number of days, such number
will refer to calendar days unless Business Days are specified, and if a period
of time is specified and dates from a given day or Business Day, or the day or
Business Day of an act or event, it is to be calculated exclusive of that day or
Business Day; (i) “monthly” means on a calendar month basis, (j) “quarter” or
“quarterly” means on a Calendar Quarter basis; (k) “annual” or “annually” means
on a Calendar Year basis; (l) “year” means a three hundred sixty-five (365) day
period unless Calendar Year is specified; (m) “$” or “dollars” means U.S.
Dollars; (n) references to a particular Person include such Person’s successors
and assigns to the extent not prohibited by this Agreement; (o) all words used
in this Agreement will be construed to be of such gender or number as the
circumstances require; (p) a capitalized term not defined herein but reflecting
a different part of speech than a capitalized term which is defined herein shall
be interpreted in a correlative manner; (q) any definition of or

 

114

--------------------------------------------------------------------------------

reference to any agreement, instrument or other document herein shall be
construed as referring to such agreement, instrument or other document as from
time to time amended, supplemented or otherwise modified (subject to any
restrictions on such amendments, supplements or modifications set forth herein);
(r) the words “hereof,” “herein,” “hereby” and derivative or similar words refer
to this Agreement (including any Exhibits or Schedules); (s) neither Party or
its Affiliates shall be deemed to be acting “on behalf of” the other Party
hereunder, except to the extent expressly otherwise provided; (t) there shall be
no double-counting in calculating Development Costs or Net Profit or Loss or any
components thereof; and (u) provisions that require that a Party, the Parties or
any Committee or Working Group hereunder “agree”, “consent” or “approve” or the
like shall be deemed to require that such agreement, consent or approval be
specific and in writing in a written agreement, letter or approved minutes, but,
except as expressly provided herein, excluding e-mail and instant messaging).

14.18. Further Assurances.

14.18.1. Each Party shall duly execute and deliver, or cause to be duly executed
and delivered, such further instruments and do and cause to be done such further
acts and things, including the filing of such assignments, agreements,
documents, and instruments, as may be necessary or as the other Party may
reasonably request in connection with this Agreement or to carry out more
effectively the provisions and purposes hereof, or to better assure and confirm
unto such other Party its rights and remedies under this Agreement.

14.18.2. If, during the Term, either Party determines that a filing or
notification under any applicable antitrust law, including the HSR Act, is
necessary or advisable at a date after the Execution Date during the Term, then
such Party shall indicate the same by providing notice to the other Party as
promptly as practicable (but in any event within ten (10) business days). The
costs and expenses associated with such notifications and filings shall be
considered Allowable Expenses in accordance with Exhibit A. Each Party shall use
its commercially reasonable efforts to obtain the expiration or termination of
the applicable waiting period under the HSR Act, and to obtain the termination
or expiration of any other applicable waiting periods or any necessary approvals
or consents under any other applicable antitrust law, at the earliest possible
date after the date of filing.

14.19. Ambiguities; No Presumption. Each of the Parties acknowledges and agrees
that this Agreement has been diligently reviewed by and negotiated by and
between them, that in such negotiations each of them has been represented by
competent counsel and that the final agreement contained herein, including the
language whereby it has been expressed, represents the joint efforts of the
Parties hereto and their counsel. Accordingly, in interpreting this Agreement or
any provision hereof, no presumption shall apply against any Party as being
responsible for the wording or drafting of this Agreement or any such provision,
and ambiguities, if any, in this Agreement shall not be construed against any
Party, irrespective of which Party may be deemed to have authored the ambiguous
provision.

14.20. Records Generally. Without limiting any of the Party’s obligations set
forth in any other provision of this Agreement or the Related Agreements, each
Party shall keep or cause its Affiliates to keep records as are appropriate to
document such Party’s, and its Affiliates’, compliance with its obligations
hereunder, under the Related Agreements, and under applicable Law, pertaining to
Manufacturing, quality control and quality assurance matters, and Development
(including clinical activities), in a manner consistent with this Agreement and
each applicable Related Agreement for those periods applicable to such records
in accordance with applicable Laws and each applicable Related Agreement.

[Remainder of this page intentionally blank.]

 

115

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IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by
its authorized representative under seal, in duplicate on the Execution Date.

 

INFINITY PHARMACEUTICALS, INC.

/s/ Adelene Q. Perkins

Name: Adelene Q. Perkins Title: President and Chief Executive Officer ABBVIE
INC.

/s/ William J. Chase

Name: William J. Chase Title: Executive Vice President, Chief Financial Officer

 

116

--------------------------------------------------------------------------------

SCHEDULE 1.40

EXCLUSIVITY COMPOUNDS

For a given small molecule compound, such compound meets the PI3K selectivity
criteria as described below:

[**]

[**] see Schedule A).

--------------------------------------------------------------------------------

SCHEDULE A

[**] DESCRIPTION

[**]

--------------------------------------------------------------------------------

SCHEDULE 3.5.1

NON-ROYALTY PAYMENTS UNDER EXISTING INFINITY THIRD PARTY

AGREEMENTS

Milestone Events and Milestone Payments

Capitalized words used in this Schedule 3.5.1 have the meaning given to them in
the

Intellikine Agreement.

Infinity will pay to Intellikine the Milestone Payments shown below within [**]
days after Infinity becomes aware of achievement of such Milestone Event (or in
the case of the achievement of Milestone Event in row 3, Column 3, upon the
Effective Date).

For purposes of clarity:

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of two pages were omitted. [**]

--------------------------------------------------------------------------------

No.

  

Milestone Event

   Column C:
Milestone Payment
upon achievement by
the first Licensed
Compound or
Product to have
achieved the
Milestone Event in
the relevant row
(US$)      Column D:
Milestone Payment
upon achievement by
the next Licensed
Compound or Product
to have achieved the
Milestone Event in the
relevant row, other
than the Licensed
Product which
achieved the Milestone
Event in such row in
Column C (US$) 1.    Initiation of the first IND-enabling cGLP toxicology study
for a Licensed Compound (other than INK1197)     

 

$1,000,000

PAID

  

  

   N/A 2.    First Patient, First Visit in a Phase I Study     

 

$3,000,000

PAID

  

  

   $1,000,000

PAID

3.    First Patient, First Visit in a Phase II Study     

 

$5,000,000

PAID

  

  

   [**] 4.    First Patient, First Visit in a Phase III Study     

 

$10,000,000

PAID

  

  

   [**] 5.    [**]      [**]       [**] 6.    [**]      [**]       [**] 7.   
[**]      [**]       [**] 8.    [**]      [**]       [**] 9.    [**]      [**]
      [**] 10.    [**]      [**]       [**] 11.    [**]      [**]       [**] 12.
   [**]      [**]       [**] 13.    [**]      [**]       [**] 14.    [**]     
[**]       [**] 15.    [**]      [**]       [**] 16.    [**]      [**]      
[**] 17.    [**]      [**]       [**] 18.    [**]      [**]       [**] 19.   
[**]      [**]       [**]

TOTAL ALL MILESTONES:

     U.S.$475,000,000      

 

--------------------------------------------------------------------------------

SCHEDULE 4.6.1

PRE-EXECUTION DATE DEVELOPMENT COSTS

 

     Estimated Amount ($)  

[**]

     [**]   

[**]

     [**]   

[**]

     [**]   

Total

     [**]   

--------------------------------------------------------------------------------

SCHEDULE 7

FINANCIAL TERMS

7.1 Upfront and Milestone Payments.

7.1.1 Upfront Payment. In partial consideration of the rights granted to AbbVie
under this Agreement, AbbVie shall make a non-refundable, non-creditable payment
of Two-Hundred Seventy-Five Million Dollars (US $275,000,000) to Infinity within
forty-five (45) days after the Effective Date.

7.1.2 Milestone Payments. AbbVie would pay Infinity the following one-time
milestone payments (each, a “Milestone Payment”) within [**] days after first
achieving each of the following milestones in the relevant jurisdiction (each, a
“Milestone Event”):

 

Milestone Event    [**]    [**] [**]    [**]    [**]    [**]    [**] [**]   
[**]    [**] [**]    [**]    [**]

--------------------------------------------------------------------------------

For purposes of this Section 7.1.2, [**].

Each milestone payment would be payable only upon first achievement, and no
amounts would be due for subsequent or repeated achievements, whether for the
same or different Product. For clarity, the Milestone Payment payable on the
[**].

7.1.3 Milestone Event Notice. Within [**] Business Days after a Party becomes
aware that a Milestone Event was achieved, it shall notify the other Party
thereof in writing.

--------------------------------------------------------------------------------

SCHEDULE 10.2.7

LITIGATION

[**].

--------------------------------------------------------------------------------

EXHIBIT A

FINANCIAL EXHIBIT

“Net Profit or Loss” in the United States shall be calculated in accordance with
this Exhibit A. Net Profit or Loss shall exclude all of the payments set forth
in Section 7.1, all Development Costs and capital expenditures, and any other
cost not specifically included in Allowable Expenses, including costs
attributable to general corporate activities, executive management, investor
relations, treasury services, business development, corporate government
relations, external financial reporting and other overhead activities. For the
sake of clarity, cost items included in components of Net Profit or Loss shall
not be double counted and shall not be included in Development Costs.

Calculation of Net Profit or Loss

Net Profit or Loss in the United States shall be calculated for each Calendar
Quarter by determining the Net Sales of Products in the United States, adding
any other income and subtracting the sum of the Allowable Expenses (in each
case, to the extent not already deducted from Net Sales and with respect to the
Products in the United States) incurred with regard to Products in the United
States during such Calendar Quarter. Notwithstanding the foregoing, on a
Calendar Year-to-date basis, Allowable Expenses shall not be included in such
calculation if such expenses are in excess of the amounts allocated for such
Calendar Year-to-date period in the US Commercialization Budget and each Party
will be solely responsible for Allowable Expenses it incurs in excess of the
amounts set forth in the US Commercialization Budget; provided, however, that
Allowable Expenses in excess of the US Commercialization Budget shall be
included in the calculation of Net Profit or Loss (i) if the JSC approves such
excess Allowable Expenses (either before or after they are incurred), which
approval shall not be unreasonably withheld to the extent the Allowable Expenses
in excess of the US Commercialization Budget were not within the reasonable
control of the Party (or Party’s Affiliate) incurring such expense; (ii) to the
extent such excess does not exceed by more than ten percent (10%) of the total
Allowable Expenses allocated to be incurred by such Party and its Affiliates in
the applicable Calendar Year-to-date period in accordance with the US
Commercialization Budget for such Calendar Year; provided, however, that if any
such excess Allowable Expenses are excluded from sharing by the Parties for a
particular Calendar Year-to-date period pursuant to the foregoing clause, such
excess Allowable Expenses shall be carried forward to subsequent Calendar
Quarters (provided, that such Calendar Quarters fall within the same Calendar
Year); or (iii) if such Allowable Expense is a Shared Product Liability Cost
which were not anticipated at the time the US Commercialization Budget was
established for a Calendar Year, in which case such Shared Product Liability
Costs shall not be included for determining whether the Parties have exceeded
the amounts budgeted to be incurred by such Parties in such Calendar Year for
Allowable Expenses.

--------------------------------------------------------------------------------

Definitions

The following definitions shall apply for purposes of calculating pre- and
post-Commercialization Net Profit or Loss in accordance with this Exhibit A.

(1) “Allowable Expenses” means, subject to the other provisions of this
Agreement and any US Commercialization Plan hereunder, the sum of the following
costs and expenses incurred following the Effective Date by the Parties or their
Affiliates, in the course of the Commercialization of the Products in the US
Territory in accordance with this Agreement during the applicable Calendar
Quarter or the applicable Calendar Year, in each case that are incurred in
accordance with the US Commercialization Budget (each as defined in the section
listed in parentheses below):

 

  a. Blocking Third Party Intellectual Property Costs (Section 1.12);

 

  b. Distribution Costs (Exhibit A, Section (4));

 

  c. EAP Expenses (Exhibit A, Section (5));

 

  d. Infinity Third Party Agreement Payments (Section 1.83);

 

  e. Health Care Reform Fees (Exhibit A, Section (6));

 

  f. Marketing Expenses (Exhibit A, Section (7));

 

  g. Other Commercialization Costs (Exhibit A, Section (9));

 

  h. Product Trademark Costs (Section 8.7.2(c)(iii));

 

  i. Recall Expenses (Exhibit A, Section (11));

 

  j. Regulatory Maintenance Costs (Exhibit A, Section (12));

 

  k. Selling Expenses (Exhibit A, Section (8));

 

  l. [**];

 

  m. [**]

 

  n. Shared Product Liability Costs (Section 11.4.3);

 

  o. Alliance Manager Expenses ((Exhibit A, Section (2)); and

 

  p. Supply Price of Products for Commercialization (Exhibit A, Section (13)).

For clarity, it is understood that Allowable Expenses shall include only
Out-of-Pocket Costs and Commercial FTE Costs, and shall exclude Development
Costs, and that internal costs of a Party and its Affiliates shall be reimbursed
only as reflected in Commercial FTE

--------------------------------------------------------------------------------

Costs. Notwithstanding anything to the contrary in this Exhibit A, to the extent
that any activity is conducted (or an Out-of-Pocket Cost or Commercial FTE Cost
is incurred) in support of both a Product and other products, services or
efforts of a Party, or are not solely attributable to a Product, or are not
solely attributable to the US Territory, then the Out-of-Pocket Costs and
Commercial FTE Costs thereof shall be included in Allowable Expenses only to the
extent included in the US Commercialization Budget, or expressly and
specifically included under this Financial Exhibit. In connection with the JCC’s
review of a proposed US Commercialization Budget, upon the request of either
Party, the JCC shall review the methodology used to allocate to the Allowable
Expenses, the Commercial FTE Costs and Out-of-Pocket Costs of such combined
activity, and if the JCC does not approve such methodology, the matter shall be
resolved by the JSC.

(2) “Alliance Manager Expenses” means the Commercial FTE Costs for the Alliance
Manager and the Out-of-Pocket Costs incurred by the Alliance Manager in
performing his/her responsibilities in accordance with this Agreement, to the
extent such expenses are allocated to the US Territory by the JCC.

(3) “Commercial FTE Costs”, which equals the relevant Commercial FTEs times the
appropriate FTE Rate, where

(a) “Commercial FTEs” means personnel engaged full time for one (1) Calendar
Year (consisting of at least a total of [**] hours per Calendar Year) in
performing Commercialization activities under the US Commercialization Plan. No
additional payment shall be made with respect to any person who works more than
[**] hours per Calendar Year and any person who devotes less than [**] hours per
Calendar Year (or such other number as may be agreed by the JCC or JSC, as
applicable) shall be treated as a Commercial FTE on a pro rata basis based upon
the actual number of hours worked divided by [**]; provided that such person
devotes a minimum of [**] hours per Calendar Year to performing
Commercialization activities under the US Commercialization Plan.

(4) “Distribution Costs” means a fixed percent of Net Sales in the US Territory,
such percent to be determined by the JCC with input and support from the Finance
Working Group, which amount shall be deemed to have been incurred as Allowable
Expenses by the Parties. It is understood that such amount shall be deemed to
cover all Out-of-Pocket Costs and Commercial FTE Costs specifically identifiable
or reasonably allocable to the distribution of Products, including customer and
wholesaler services, order entry, billing, shipping, logistics, warehousing,
product insurance, freight not paid by customers, credit and collection and
other like activities the costs of which are includable in “Distribution Costs”
in accordance with the applicable Accounting Standards, consistently applied,
which shall not otherwise be included in Allowable Expenses. For clarity,
“Distribution Costs” shall not include costs of activities included within
Marketing Expenses or Selling Expenses.

(5) “EAP Expenses” means the Out-of-Pocket Costs and Development FTE Costs or
Medical Affairs FTE Costs to conduct Early Access Programs for the Product in
accordance with this Agreement.

--------------------------------------------------------------------------------

(6) “Health Care Reform Fees” means Out-of-Pocket Costs representing the annual
fee paid to the U.S. government as defined in the ACA and similar taxes and
governmental fees in the United States, in each case to the extent directly
attributable to the Product.

(7) “Marketing Expenses” means Out-of-Pocket Costs and Commercial FTE Costs
identifiable to the advertising, promotion and marketing of a Product in the
Field in the US Territory, and related professional education, in each case to
the extent incurred specifically with respect to a Product (and to the extent
not performed by Sales Representatives) in the US Territory, including:

a. Advertising, which includes Out-of-Pocket Costs and Commercial FTE Costs
associated with media costs, direct mails, production expenses, agency fees, and
medical congresses and meetings and other advertising activities;

b. Promotion, which includes Out-of-Pocket Costs and Commercial FTE Costs
associated with professional samples, reimbursement of patient assistance
programs, public relations and communications expenses, development of
information and data for national accounts, managed care organizations and group
purchasing organizations and other promotional activities;

c. Market Research, which includes Out-of-Pocket Costs and Commercial FTE Costs
associated with market information, focus groups, and market research
professional staff and related Out-of-Pocket Costs such as travel, business
meals;

d. Marketing Management, which includes the Out-of-Pocket Costs and Commercial
FTE Costs of product management, to the extent directly performing activities
with respect to the marketing and brand strategy development of Products;

e. Reimbursement/Access Services, which includes Out-of-Pocket Costs incurred to
manage marketing programs, marketing costs (educational material) as well as
coupon or co-pay programs directly attributable to a Product; provided, however,
that, if employees of Infinity or AbbVie or any of their respective Affiliates
provide this service, then the Commercial FTE Costs of such employees and the
related Out-of-Pocket Costs such as travel, business meals, and entertainment
will be included;

f. Health Policy/Advocacy, which includes Out-Of-Pocket Costs reasonably
necessary and identifiable to a Product, such as advocacy sponsorships for the
Product’s specific disease state as well as any specific policy lobbying and
trade and government relations related expenses, in each case to the extent
attributable to and specifically conducted with respect to such Product;

g. Activities involving key opinion leaders;

h. Launch meetings;

--------------------------------------------------------------------------------

i. Conducting advisory board meetings or other consultant programs, the purpose
of which is to obtain advice and feedback related to the Commercialization of a
Product; and

j. Web site (product or disease state) development, implementation and fees.

(8) “Selling Expenses” includes Out-of-Pocket Costs and Commercial FTE Costs
reasonably necessary and identifiable to the Product incurred with respect to:
sales representatives, sales managers, sales deployment planning, customer
targeting, payor and reimbursement activities, and hospital and managed health
care activities. The Sales Representative FTEs and Sales Manager FTEs are
calculated as described in the definitions thereof. All other Selling Expense
FTE Costs are as described in this Exhibit A, Section (3). Costs for performance
reporting and Sales Force Automation (SFA) tools and hardware, such as laptops
or tablets used to track activity, are not billable costs under this Agreement
unless shared systems are developed and mutually agreed as a billable cost.

(9) “Other Commercialization Costs” means any Out-of-Pocket Costs and Commercial
FTE Costs approved by the JCC and included in the US Commercialization Plan and
the US Commercialization Budget that is not otherwise included in any other
Allowable Expense category. It is understood that Other Commercialization Costs
shall not include costs associated with Development activities.

(10) “Other Income” means any payment or income (other than Net Sales) received
by a Party (or its Affiliate) from the other Party (or its Affiliate) or a Third
Party that is attributable to a Product or is received in connection with the
grant of a sublicense or other right or activity with respect to the Products.

(11) “Recall Expenses” means Out-of-Pocket Costs and Commercial FTE Costs
directly associated with notification, retrieval and return of a Product,
destruction of such returned Product, replacement Product and distribution of
the replacement Product, in each case that are incurred with respect to a Recall
conducted in accordance with Section 5.1.2 of the Agreement; the Parties
acknowledge that if the Recall was not anticipated at the time the US
Commercialization Budget was established for a Calendar Year, then the Recall
Expenses shall not be included for determining whether the Party conducting such
Recall has exceeded the amounts budgeted to be incurred by such Party in such
Calendar Year for Allowable Expenses. Notwithstanding the foregoing, for
clarity, Recall Expenses that are Losses entitled to indemnification under
Sections 11.1(b) or 11.2(b) shall be solely borne by the relevant Indemnifying
Party, and shall not be shared hereunder.

(12) “Regulatory Maintenance Costs” means Out-of-Pocket Costs and Commercial FTE
Costs for maintenance fees relating to Marketing Authorizations for the Products
in the Field in the US, and personnel engaged in the filing and maintenance of
Marketing Authorizations in the US.

--------------------------------------------------------------------------------

(13) “Supply Price” means, with respect to a Product, the Manufacturing cost for
such Product, which (a) to the extent such Product is Manufactured by a Party or
its Affiliates, shall approximate a reasonable definition of cost of goods sold
for such Product with no markup, assuming full utilization of Manufacturing
capacity, and (b) to the extent such Product is Manufactured by a Third Party in
an arms-length transaction, the Out-of-Pocket Costs paid to such Third Party for
the Manufacture of such Product.

General Principles.

Allowable Expenses shall initially be borne by the Party incurring the cost or
expense, subject to reimbursement as provided herein.

Each Party shall provide financial statements in such reporting format as the
Finance Working Group may establish for use by the Parties.

All calculations to be made pursuant to this Financial Exhibit shall be made in
accordance with (i) the applicable definitions and terms set forth in this
Financial Exhibit and in the Agreement in a manner consistent with the
methodologies used for the US Commercialization Budgets (first priority),
(ii) the specific accounting policies as may be established by the Finance
Working Group (second priority) and (iii) applicable Accounting Standards,
consistently applied (third priority). All undefined terms shall be construed in
accordance with applicable Accounting Standards, consistently applied, but only
to the extent consistent with the other express terms and definitions in this
Financial Exhibit and the Agreement and specific accounting policies established
by the Finance Working Group.

For clarity, income and withholding taxes imposed on either of the Parties or
their Affiliates hereunder will not be included in the calculation of Net Profit
or Loss.

Losses from Third Party Claims; Exclusion of Costs Due to Breach or Subject to
Indemnification under Section 11.1 or 11.2

The Parties agree that Losses that arise out of the performance, in good faith,
of Development, Manufacture, Commercialization or other exploitation of Products
in or for the United States following the Effective Date in accordance with the
Agreement (“Collaboration Losses”) will be charged to the Net Profit or Loss;
provided, that Net Profit or Loss will not include Losses or costs of a Party or
its Affiliate that are: (i) caused by a breach of this Agreement by such Party
or Affiliate; or (ii) subject to indemnification by such Party pursuant to
Section 11.1 or Section 11.2 (except for Product Liability Costs, which will be
treated in accordance with Section 11.4 as set forth therein) (and for clarity,
if a Third Party makes a Third Party Claim (other than a Product Liability
Action for which the costs are shared as Shared Product Liability Costs)
directly against Infinity (or any of its Affiliates) or AbbVie (or any of its
Affiliates), respectively, that would otherwise be indemnified by Infinity or
AbbVie, respectively, if such Third Party Claim had been made against the other
Party (or any of its Affiliates), then Losses incurred by Infinity or AbbVie in
connection with such direct Third Party Claim will not be included in the
calculation of Net Profit or Loss).

--------------------------------------------------------------------------------

Reconciliations

The Finance Working Group will coordinate to resolve any differences in or
disputes regarding the calculation of Net Profit or Loss, or any component
thereof. If the Finance Working Group is unable to resolve any such difference
or dispute, the matter shall be resolved by the JSC.

--------------------------------------------------------------------------------

EXHIBIT B-1

OWNED INFINITY PATENT RIGHTS

 

Title

   Country    Application
Number    Publication
Number    Patent Number    Filing
Date

[**]

   [**]    [**]          [**]

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of three pages were omitted. [**]

--------------------------------------------------------------------------------

EXHIBIT B-2

IN-LICENSED INFINITY PATENT RIGHTS

 

Title

   Country    Application
Number    Publication
Number    Patent Number    Filing
Date

[**]

   [**]    [**]          [**]

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of three pages were omitted. [**]

--------------------------------------------------------------------------------

EXHIBIT C

GLOBAL DEVELOPMENT PLAN

1. Initial Global Development Plan

[**]

2. IPI-145 Clinical Study Details

 

[**] Objective    The goal of this study is to [**]. Study Design    This study
consists of [**]. Dosing Arms   

The dose expansion cohorts are:

[**]

Patient Population    [**] Endpoints    Estimated Enrollment    [**] Notes   
[**] [**]    Objective    To evaluate the [**]. Study Design    [**] Dosing Arms
   [**] Patient Population    [**] Endpoints    [**] Estimated Enrollment   
[**] Notes    [**] [**]    Objective    To evaluate the [**] Study Design   
[**] Dosing Arms    [**] Patient Population    [**] Endpoints    [**] Estimated
Enrollment    [**]

--------------------------------------------------------------------------------

[**]    Objective    To evaluate the [**] Study Design    [**] Dosing Arms   
[**] Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**]
[**]    Objective    To evaluate the [**] Study Design    [**] Dosing Arms   
[**] Patient Population    [**] Endpoints    [**] Estimated    [**] [**]   
Objective    To characterize [**]. Study Design    [**] Dosing Arms    [**]
Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**] Notes
   [**]

--------------------------------------------------------------------------------

[**]    Objective    To evaluate the [**]. Study Design    [**] Dosing Arms   
[**] Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**]
Notes    [**] [**]    Objective    [**] Study Design    [**] Dosing Arms   
Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**] [**]
   Objective    To establish [**]. Study Design    [**] Dosing Arms    [**]
Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**] [**]
   Objective    To evaluate the [**]. Study Design    [**] Dosing Arms    [**]
Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**] Notes
   [**]

--------------------------------------------------------------------------------

[**]    Objective    To study [**]. Study Design    [**] Dosing Arms    [**]
Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**] Notes
   [**] [**]    Objective    To establish [**]. Study Design    [**] Dosing Arms
   [**] Patient Population    [**] Endpoints    [**] Estimated Enrollment   
[**]

--------------------------------------------------------------------------------

[**]    Objective    To evaluate the [**]. Study Design    [**] Dosing Arms   
[**] Patient Population    [**] Endpoints    [**] Estimated Enrollment    [**]
Notes    [**] [**]    Objective    To enable [**]. Study Design    [**] Dosing
Arms    [**] Patient Population    [**] Endpoints    [**] Estimated Enrollment
   [**] Notes    [**] [**]    Objective    To study the [**]. Study Design   
[**] Dosing Arms    Patient Population    [**] Endpoints    [**] Estimated
Enrollment    [**] Notes    [**]

--------------------------------------------------------------------------------

3. Budget for Infinity Conducted Studies and Activities in Initial Global
Development Plan (GDP) Excluding AbbVie Conducted and Investigator Sponsored
Studies and Activities

[**]

4. Budget for AbbVie Conducted Studies and Activities in Initial Development
Plan (GDP) Excluding Infinity Conducted and Investigator Sponsored Studies and
Activities

[**]

5. IPI-145 CMC Activity Plan

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of three pages were omitted.

[**]

6. Budget for IPI-145 CMC Activity Plan

[**]

--------------------------------------------------------------------------------

EXHIBIT D

IPI-145

 

LOGO [g791556g66l57.jpg]

--------------------------------------------------------------------------------

EXHIBIT E

PRESS RELEASE

 

 

LOGO [g791556g82h03.jpg]

FOR RELEASE ON WEDNESDAY, SEPTEMBER 3, 2014, AT 6:45 A.M. ET

Contacts:

Infinity Pharmaceuticals, Inc.

Jaren Irene Madden, 617-453-1336

Jaren.Madden@infi.com

http://www.infi.com

AbbVie

Adelle Infante, 847-938-8745

adelle.infante@abbvie.com

http://www.abbvie.com

INFINITY AND ABBVIE ANNOUNCE GLOBAL STRATEGIC

COLLABORATION TO DEVELOP AND COMMERCIALIZE DUVELISIB

(IPI-145) IN ONCOLOGY

– Infinity to Receive $275 Million Up-Front Payment and $530 Million in
Potential

Milestones –

– Companies to Jointly Develop and Commercialize Duvelisib in U.S., with Equal
Profit

Share; Infinity to Receive Royalties on Sales Outside the U.S. –

– Infinity to Host Conference Call Today at 8:30 A.M. ET/7:30 A.M. CT –

Cambridge, MA and North Chicago, Ill – September 3, 2014 – Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) and AbbVie Inc. (NYSE: ABBV) today
announced that they have entered into a global collaboration to develop and
commercialize duvelisib (IPI-145), Infinity’s oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of
patients with cancer. Duvelisib has shown clinical activity across a broad range
of blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic
lymphocytic leukemia (CLL). Infinity is conducting registration-focused trials
evaluating the safety and efficacy of duvelisib, including DYNAMOTM, a Phase 2
study in patients with iNHL, and DUOTM, a Phase 3 study in patients with CLL.

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Under the terms of the agreement, Infinity will receive an upfront payment of
$275 million and is eligible to receive up to $530 million in additional
payments for the achievement of development, regulatory and commercial
milestones, including up to $405 million for the achievement of milestones
through the first commercial sale of duvelisib. In the U.S., the companies will
jointly commercialize duvelisib and will share equally in any potential profits.
Outside the U.S., AbbVie will be responsible for the conduct and funding of
commercialization of duvelisib, and Infinity is eligible to receive tiered
double-digit royalties on net product sales.

“We believe that duvelisib is a very promising investigational treatment based
on clinical data showing activity in a broad range of blood cancers,” said
Michael Severino, M.D., AbbVie executive vice president and chief scientific
officer. “The addition of duvelisib will complement AbbVie’s emerging oncology
pipeline and expand our research into combination therapies to generate improved
outcomes for cancer patients. We look forward to working with Infinity to bring
duvelisib to patients worldwide.”

“This collaboration is an important step toward fulfilling Infinity’s objective
of bringing better treatments to patients and further advances our goal of
building a sustainable, fully integrated biotechnology company,” stated Adelene
Q. Perkins, chair, president and chief executive officer at Infinity. “AbbVie
will be a wonderful partner for Infinity, bringing all of the expertise and
scale of a successful, well established company, together with the energy,
drive, innovation, and nimbleness of a young organization. We look forward to
advancing duvelisib through monotherapy studies designed to enable registration
and in furthering our shared longer-term vision of combining duvelisib with both
current standards of care and novel, targeted therapies.”

Additional Details About the Collaboration

Development and commercialization activities under the collaboration will be
managed through a shared governance structure. In the U.S., Infinity and AbbVie
will jointly commercialize duvelisib, assuming regulatory approval, with
Infinity booking sales, and will share equally in any potential profits or
losses. Outside the U.S., AbbVie will be responsible for conducting and funding
of any commercialization of duvelisib, and Infinity is eligible to receive
tiered royalties on net product sales, with percentages ranging from 23.5
percent to 30.5 percent.

For sales of duvelisib in the U.S., AbbVie and Infinity will share equally the
existing royalty obligations to Mundipharma International Corporation
Limited/Purdue Pharmaceutical Products L.P., and Infinity will be responsible
for these royalty obligations outside of the U.S. Infinity will also be
responsible for the existing royalty obligations to Millennium: The Takeda
Oncology Company for sales of duvelisib worldwide.

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As part of the strategic collaboration, the companies will share responsibility
for the conduct of specific trials specified within an agreed-upon global
development plan, with each company leading the development of certain trials
within the plan. For the initial global development plan agreed to by the
companies, Infinity will fund the trials it conducts and the companies will
share equally the funding of trials conducted by AbbVie. The agreement includes
plans to launch multiple Phase 2 and Phase 3 studies of duvelisib in hematologic
malignancies over the next several years.

Conference Call Today at 8:30 a.m. ET/7:30 a.m. CT

Infinity will hold a conference call at 8:30 a.m. to discuss the strategic
collaboration announced today. A live webcast of the conference call can be
accessed in the Investors/Media section of Infinity’s website at www.infi.com.
To participate in the conference call, please dial (877) 316-5293 (domestic) and
(631) 291-4526 (international) five minutes prior to start time. The conference
ID number is 97402440. An archived version of the webcast will be available on
Infinity’s website for 30 days.

About the Development of Duvelisib for the Treatment of Blood Cancers

Infinity and AbbVie are developing duvelisib, an oral inhibitor of Class I
PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple
cellular functions, including cell proliferation and survival, cell
differentiation, cell migration and immunity. The PI3K-delta,gamma isoforms are
preferentially expressed in leukocytes (white blood cells), where they have
distinct and mostly non-overlapping roles in immune cell development and
function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities
to develop differentiated therapies for the treatment of hematologic
malignancies.

In 2013, Infinity launched the DUETTSTM (Duvelisib Trials in Hematologic
Malignancies) program, a worldwide investigation of duvelisib in blood cancers.
As part of the DUETTS program, patient enrollment is ongoing in DYNAMOTM, a
Phase 2 monotherapy study designed to evaluate the safety and efficacy of
duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL)
(ClinicalTrials.gov Identifier NCT01882803), and DUOTM, a Phase 3 monotherapy
study designed to evaluate the safety and efficacy of duvelisib in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL) (NCT02004522).
DYNAMO+RTM, a Phase 3 study of duvelisib in combination with rituximab in
patients with previously treated follicular lymphoma (NCT02204982), is expected
to start in 2014.

Additionally, a Phase 1 study of duvelisib in patients with advanced blood
cancers is ongoing (NCT01476657).

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About Infinity Pharmaceuticals, Inc.

Infinity is an innovative biopharmaceutical company dedicated to discovering,
developing and delivering best-in-class medicines to people with
difficult-to-treat diseases. Infinity combines proven scientific expertise with
a passion for developing novel small molecule drugs that target emerging disease
pathways. For more information on Infinity, please refer to the company’s
website at www.infi.com.

About AbbVie Inc.

AbbVie is a global, research-based biopharmaceutical company formed in 2013
following separation from Abbott Laboratories. The company’s mission is to use
its expertise, dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world’s most complex and
serious diseases. AbbVie employs approximately 25,000 people worldwide and
markets medicines in more than 170 countries. For further information on the
company and its people, portfolio and commitments, please visit www.abbvie.com.
Follow @abbvie on Twitter or view careers on AbbVie’s Facebook or LinkedIn page.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include those regarding the Company’s expectations about: the receipt
of upfront, milestone, royalty and other payments under the agreement with
AbbVie; the therapeutic and commercial potential of duvelisib; the expected
benefits of the collaboration with AbbVie; the advancement of duvelisib through
clinical trials; plans to conduct additional clinical trials of duvelisib; and
its ability to execute on its strategic plans. Such statements are subject to
numerous important factors, risks and uncertainties that may cause actual events
or results to differ materially from the company’s current expectations. For
example, there can be no guarantee that Infinity will report data in the time
frames it has estimated, that any product candidate Infinity is developing will
successfully complete necessary preclinical and clinical development phases, or
that development of any of Infinity’s product candidates will continue. Further,
there can be no guarantee that Infinity’s strategic collaboration with AbbVie
will continue or that any positive developments in Infinity’s product portfolio
will result in stock price appreciation. Management’s expectations and,
therefore, any forward-looking statements in this press release could also be
affected by risks and uncertainties relating to a number of other factors,
including the following: Infinity’s results of clinical trials and preclinical
studies, including subsequent analysis of existing data and new data received
from ongoing and future studies; a failure of Infinity and/or AbbVie to fully
perform under the strategic collaboration and/or an early termination of the
collaboration and license agreement; the content and timing of decisions made by
the U.S. FDA and other regulatory authorities, investigational review boards at
clinical trial sites and publication review bodies; Infinity’s ability to obtain
and maintain requisite regulatory approvals and to enroll patients in its
clinical trials; unplanned cash requirements and expenditures; development of
agents by Infinity’s competitors for diseases in which Infinity is currently
developing or intends to develop its product candidates; and Infinity’s ability
to obtain, maintain and enforce patent and other intellectual property
protection for

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any product candidates it is developing. These and other risks which may impact
management’s expectations are described in greater detail under the caption
“Risk Factors” included in Infinity’s quarterly report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on August 11, 2014, and other
filings filed by Infinity with the SEC. Any forward-looking statements contained
in this press release speak only as of the date hereof, and Infinity expressly
disclaims any obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.

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EXHIBIT F

AbbVie Combination Compound

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