Document:

exv10w2

Exhibit 10.2

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

Amended and Restated

Strategic License Agreement

by and between

Avila Therapeutics, Inc.

and

Clovis Oncology, Inc.

June 16, 2011

 

Amended and Restated Strategic License Agreement

Table of Contents

	 	 	 	 	 	 
	 	 	 	 	 	Page
	1.
	 	Definitions	 	 	1
	 
	 	 	 	 	 
	2.
	 	Collaboration Program	 	 	8
	 
	 	 	 	 	 
	3.
	 	Governance	 	 	9
	 
	 	 	 	 	 
	4.
	 	Development and Commercialization	 	 	11
	 
	 	 	 	 	 
	5.
	 	License Grants	 	 	12
	 
	 	 	 	 	 
	6.
	 	Payments and Royalties	 	 	14
	 
	 	 	 	 	 
	7.
	 	Ownership of Collaboration Program Know-How	 	 	21
	 
	 	 	 	 	 
	8.
	 	Patent Prosecution and Maintenance	 	 	22
	 
	 	 	 	 	 
	9.
	 	Patent Enforcement and Defense	 	 	24
	 
	 	 	 	 	 
	10.
	 	Confidentiality	 	 	26
	 
	 	 	 	 	 
	11.
	 	Warranties; Limitations of Liability; Indemnification	 	 	28
	 
	 	 	 	 	 
	12.
	 	Term and Termination	 	 	31
	 
	 	 	 	 	 
	13.
	 	General Provisions	 	 	34

 

Amended and Restated Strategic License Agreement

List of Exhibits and Schedules

	 	 	 

	 
	Exhibit 1.7
	 	Avila Patents as of the Effective Date
	 
	Exhibit 1.53
	 	Targets
	 
	Exhibit 2.1(b)
	 	Collaboration Plan
	 
	Exhibit 2.1(c)
	 	Initial Agreed Compound Profile
	 
	Exhibit 8.1(a)
	 	Proposed Prosecution and Maintenance Activities for Subject Patents
	 
	Exhibit 10.3(c)
	 	Joint Press Release

 

Amended and Restated Strategic License Agreement

Amended and Restated Strategic License Agreement

          This Amended and Restated Strategic License Agreement (this “Agreement”), dated as of June 16,
2011 (the “A&R Date”), is made by and between Avila Therapeutics, Inc., a Delaware corporation
(“Avila”), and Clovis Oncology, Inc, a Delaware corporation (“Clovis”). Each of Avila and Clovis
may be referred to herein as a “Party” or together as the “Parties.”

          WHEREAS, Avila has developed and owns or has rights to certain patents and technology relating
to the discovery and development of covalent-based drugs using its AvilomicsTM platform;

          WHEREAS, Avila has previously conducted research and development to identify potential
covalent inhibitors of the Targets (as defined below);

          WHEREAS, Clovis is a biopharmaceutical company focused on acquiring, developing and
commercializing innovative anti-cancer agents;

          WHEREAS, the Parties are interested in collaborating together to discover and develop
preclinically covalent inhibitors of the Targets and then having Clovis develop clinically and
commercialize the lead inhibitor candidate as a drug product, all in accordance with the terms and
conditions set forth below; and

          WHEREAS, the Parties entered into that certain Strategic License Agreement (the “Original
Agreement”) as of May 24, 2010 (the “Effective Date”), and the Parties now desire to amend and
restate the Original Agreement on the terms and conditions set forth below.

          NOW, THEREFORE, the Parties hereby agree as follows:

1.          Definitions.

The following terms and their correlatives will have the following meanings:

      1.1       “Affiliate” of a person or entity will mean any other entity which (directly or
indirectly) is controlled by, controls or is under common control with such person or entity. For
the purposes of this definition, the term “control” (including, with correlative meanings, the
terms “controlled by” and “under common control with”) as used with respect to an entity will mean
(i) in the case of a corporate entity, direct or indirect ownership of voting securities entitled
to cast more than fifty percent (50%) of the votes in the election of directors or (ii) in the case
of a non-corporate entity, direct or indirect ownership of more than fifty percent (50%) of the
equity interests with the power to direct the management and policies of such entity.

      1.2       “Asia” will mean the People’s Republic of China (including Hong Kong), Japan, Republic of
Korea, and Taiwan.

      1.3       “Asia Partnership” will mean an agreement between Clovis and a Sublicensee whereby Clovis
grants to such Sublicensee at least Commercialization rights for Japan (and optionally other
countries within Asia) with respect to any Lead Candidate or Licensed Products. The grant by
Clovis of an option to such Commercialization rights may be treated by Avila at its election as an
Asia Partnership for purposes of this Agreement.

      1.4       “Avila Core Technology” will mean all Patents, Materials and Know-How owned (in whole or
in part), in-licensed or otherwise controlled by Avila or any of its Affiliates comprising the
technology currently branded by Avila under the trademark AvilomicsTM and improvements thereto or
any research tools used by Avila in the research, discovery or development of covalent inhibitors.

      1.5       “Avila Owned IP” will mean any Collaboration Program Know-How, and Patents arising
therefrom, that constitute one or more of the following: (i) improvements, modifications to any
Avila Core Technology; and (ii) Research Candidates and methods of making and using the same.

1

 

Amended and Restated Strategic License Agreement

      1.6       “Avila Know-How” will mean all Know-How and Materials Controlled by Avila or any of its
Affiliates, used by Avila in the Collaboration Program, and necessary or useful to discover and
Develop preclinically Research Candidates or to Develop and Commercialize the Lead Candidate and
Licensed Products. For clarity, Avila Know-How will include, if applicable, Collaboration Program
Know-How owned in whole or in part by Avila (including Avila Owned IP).

      1.7       “Avila Patents” will mean all Patents Controlled by Avila or any of its Affiliates,
containing a Valid Claim Covering any Research Candidates or Licensed Products, and necessary or
useful to discover and Develop preclinically Research Candidates or to Develop and Commercialize
the Lead Candidate, Licensed Products and Companion Diagnostics. For clarity, Avila Patents will
include (i) Patents for occupancy probes for the Targets and (ii) if applicable, Avila’s interest
in Patents within its Sole Collaboration Program IP and within the Joint Collaboration Program IP,
including Patents constituting Avila Owned IP. The Avila Patents in existence as of the Effective
Date are set forth on Exhibit 1.7.

      1.8       “Calendar Year” will mean each successive period of twelve (12) calendar months commencing
on January 1 and ending on December 31.

      1.9       “Clovis Development & Commercialization Program” will mean a Development and
Commercialization program for the Lead Candidate and Licensed Products and Companion Diagnostics in
the Field worldwide.

      1.10      “Clovis Technology” will mean Know-How, Materials and Patents Controlled by Clovis or any
of its Affiliates necessary or useful for Avila to discover and Develop Research Candidates as part
of the Collaboration Program. For clarity, Clovis Technology will include, if applicable, (i)
Clovis’s interest in Patents within its Sole Collaboration Program IP and the Joint Collaboration
Program IP, and (ii) Collaboration Program Know-How owned in whole or in part by Clovis.

      1.11      “Collaboration Program” will mean the program of research and preclinical Development
that the Parties engage in under this Agreement.

      1.12      “Collaboration Program Know-How” will mean all Know-How and Materials created, conceived
or reduced to practice in connection with activities performed pursuant to the Collaboration
Program (whether solely by one Party or jointly by the Parties, in each case optionally with their
Affiliates and subcontractors or any employees, consultants or agents of any of the foregoing).

      1.13      “Commercialization” will mean any and all activities directed to the manufacturing,
marketing, detailing, promotion and securing of reimbursement of Licensed Products after Regulatory
Approval has been obtained (including making, having made, using, importing, selling and offering
for sale Licensed Products), and will include post-approval clinical studies, post-launch
marketing, promoting, detailing, marketing research, distributing, customer service, and
commercially selling Licensed Products, importing, exporting or transporting Licensed Products for
commercial sale, and all regulatory compliance with respect to the foregoing.

      1.14      “Commercially Reasonable Efforts” will mean, with respect to the Development or
Commercialization of the Lead Candidate and Licensed Products, that level of efforts and resources
commonly dedicated in the research-based pharmaceutical industry by a company to the development or
commercialization, as the case may be, of a product of similar commercial potential at a similar
stage in its lifecycle, in each case taking into account issues of safety and efficacy, product
profile, the proprietary position, the then current competitive environment for such product and
the likely timing of such product’s entry into the market, the regulatory environment and status of
such product, and other relevant scientific, technical and commercial factors.

      1.15      “Companion Diagnostics” will mean a diagnostic product or service to the extent sold or
used to determine whether to prescribe the Licensed Product to treat a human patient. For clarity,
no covalent

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Amended and Restated Strategic License Agreement

inhibitor (including the Lead Candidate or any Licensed Product) or occupancy probe against
any of the Targets will be included within this definition.

      1.16      The terms “compound” and “covalent inhibitor” when used herein will include the chemical
structure in question, its optical isomers, plus all solvates, salt forms and polymorphs of the
foregoing.

      1.17      “Control” or “Controlled” will mean, with respect to any Know-How, Material, Patent, or
other intellectual property right, the possession (whether by ownership or license, other than by a
license granted pursuant to this Agreement) by a Party or its Affiliates of the ability to grant to
the other Party a license or access as provided herein to such Know-How, Material or Patent,
without violating the terms of any agreement or other arrangement with any Third Party, or being
obligated to pay any royalties or other consideration therefor, in existence as of the time such
Party or its Affiliates would first be required hereunder to grant the other Party such license or
access.

      1.18      “Covers”, with reference to a Patent, will mean that the making, using, selling, offering
for sale or importing of a composition of matter or practice of a method would infringe a Valid
Claim of such Patent in the country in which such activity occurs.

      1.19      “Development” will mean, with respect to a compound, preclinical and clinical drug
development activities, including: test method development and stability testing, toxicology,
formulation, process development, qualification and validation, manufacture scale-up,
development-stage manufacturing, quality assurance/quality control, clinical studies, statistical
analysis and report writing, the preparation and submission of NDAs and MAAs, regulatory affairs
with respect to the foregoing and all other activities necessary or useful or otherwise requested
or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a
Regulatory Approval, plus pre-launch marketing, promoting, detailing, marketing research,
distributing, and commercial sales.

      1.20      “Distributors” will mean a Third Party, other than a Sublicensee of Clovis, that (i)
purchases any Licensed Products in finished form from or at the direction of Clovis or any of its
Affiliates or Sublicensees, and (ii) has the right to Commercialize such Licensed Products in one
or more regions, or has an option to do the foregoing.

      1.21      “EMA” will mean the European Medicines Agency and any successor agency thereto.

      1.22      “EU” will mean the organization of member states of the European Union as it may be
constituted from time to time.

      1.23      “FDA” will mean the United States Food and Drug Administration and any successor agency
thereto.

      1.24      “Field” will mean all indications for human use, including all therapeutic and diagnostic
uses.

      1.25      “Financial Consideration” will mean license fees, signing fees, option fees, milestone
payments and any other consideration (including non-monetary consideration) paid to, or otherwise
received by, Clovis or any of its Affiliates in consideration for the establishment of a
Sublicensee or Distributor relationship (and without reduction for any additional Patents or
Know-How or other intellectual property rights granted or commitments made in connection
therewith), but does not include (i) revenues from sales of Licensed Products by Clovis to
Sublicensees or Distributors; (ii) royalties metered on sales of Licensed Products by Selling
Parties, (iii) payments contractually committed to reimburse the Fully Allocated Costs of future
Development of the Lead Candidate and Licensed Products, provided that any amounts received in
excess of such costs (such as, for example, a profit share) will be treated as “Financial
Consideration” hereunder, and (iv) payments received to purchase securities of Clovis at fair
market value, provided that any premium paid over fair market value will be treated as “Financial
Consideration” hereunder with. For purposes of this definition, “fair market value” will be
determined on a per share basis and will mean the average closing price of Clovis common stock for
the ten (10) trading days immediately preceding the date such Sublicensee or Distributor agreement
is

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Amended and Restated Strategic License Agreement

executed, or, if there is no trading market for the security issued, the good faith
determination of the board of directors of Clovis as to its fair market value (taking into account,
inter alia, the pricing of other recent security issuances by Clovis).

      1.26      “First Commercial Sale” will mean the first sale for use or consumption of any Licensed
Product in a country after all required Regulatory Approvals for commercial sale of such Licensed
Product have been obtained in such country.

      1.27      “First Line Therapy” will mean an initial treatment or primary or induction therapy for
the treatment of patients having any of lung, breast, colon or prostate cancer.

      1.28      “FTE” will mean a full-time person, or more than one person working the equivalent of a
full-time person, where “full-time” is determined by the standard practices in the
biopharmaceutical industry in the geographic area in which such personnel are working and includes
R&D activities and scientific management oversight.

      1.29      “FTE Rate” will equal *** for twelve (12) continuous months of one (1) FTE. The FTE Rate
is the fully burdened rate for each such FTE and, for clarity, will include all standard laboratory
supplies and reagents to be used by such FTE in conducting the Collaboration Program.

      1.30      “Fully Allocated Costs” will mean the costs of labor (including allocable employee
benefits and employment taxes), material, energy, utilities or other costs directly incurred and
normal overhead (including, without limitation, administrative labor costs, maintenance, relevant
insurance, depreciation of the equipment and depreciation of the facility) all determined in
accordance with GAAP applied on a consistent basis.

      1.31      “GAAP” will mean U.S. generally accepted accounting principles, consistently applied.

      1.32      “IND” will mean an investigational new drug application filed with the FDA for
authorization to commence clinical studies, and its equivalent in a foreign country.

      1.33      “Know-How” will mean all commercial, technical, scientific and other know-how and
information, trade secrets, knowledge, technology, methods, processes, practices, formulae,
instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs,
drawings, assembly procedures, computer programs, specifications, data and results (including
biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical,
preclinical, clinical, safety, manufacturing and quality control data and know-how, including study
designs and protocols), in all cases, whether or not confidential, proprietary, patented or
patentable, in written, electronic or any other form now known or hereafter developed.

      1.34      “Knowledge” will mean the actual knowledge or good faith understanding of the vice
presidents, senior vice presidents, president or chief executive officer of a Party of the facts
and information then in their possession without any duty to conduct any investigation with respect
to such facts and information.

      1.35      “Lead Candidate” will mean the Research Candidate that the Parties mutually agree
exhibits the Agreed Compound Profile, and that Clovis will Develop pursuant to this Agreement, all
as described in Section 2.1(c).

      1.36      “Licensed Products” will mean the Lead Candidate and any pharmaceutical products
containing the Lead Candidate in any formulation.

      1.37      “MAA” will mean a Marketing Authorization Application filed with the EMA under the
centralized European procedure (including amendments and supplements thereto).

      1.38      “Materials” will mean any tangible chemical or biological material, including any
compounds, DNA, RNA, clones, cells, and any expression product, progeny, derivative or other

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Amended and Restated Strategic License Agreement

improvement thereto, along with any tangible chemical or biological material embodying any
Know-How.

      1.39      “NDA” will mean a New Drug Application or Supplemental New Drug Application filed with
the FDA (including amendments and supplements thereto).

      1.40      “Net Sales” will mean the gross amount invoiced in arms-length transactions by the
Selling Party(ies) from or on account of the sale or distribution of Licensed Products to
non-Selling Parties, less:

            (a)        reasonable credits or allowances, if any, on account of price adjustments, recalls,
rejection or return of items previously sold;

            (b)        import taxes, export taxes, excises, sales taxes, value added taxes, consumption taxes,
duties or other taxes imposed upon and paid with respect to such sales (excluding income or
franchise taxes of any kind);

            (c)        separately itemized insurance and transportation costs incurred in shipping Licensed
Products to such non-Selling Parties;

            (d)        trade, quantity and cash discounts actually allowed; and

            (e)        governmental or commercial rebates, wholesaler fees, administrative fees to managed care,
group purchasing and other similar institutions, chargebacks and retroactive price adjustments and
any other similar allowances which effectively reduce the selling price,

all as determined from the books and records of the Selling Party, maintained in accordance with
GAAP.

           Nothing herein will prevent a Selling Party from selling, distributing or invoicing Licensed
Products at a discounted price for shipments to Third Parties in connection with clinical studies,
compassionate sales, or an indigent program or similar bona fide arrangements in which the Selling
Party agrees to forego a normal profit margin for good faith business reasons. Except for such
discounting, no deduction will be made for any item of cost incurred in Developing or
Commercializing Licensed Products except as permitted pursuant to clauses (a) to (e) of the
foregoing sentence.

           Licensed Products will be considered “sold” when a sale by a Selling Party is recognized in
accordance with revenue recognition policies mandated by GAAP. Sale or transfer of Licensed
Products between any of the Selling Parties will not result in any Net Sales, and Net Sales instead
will be based on subsequent sales or distribution to a non-Selling Party, unless such Licensed
Products is consumed by a Selling Party. To the extent that any Selling Party receives
consideration other than or in addition to cash upon the sale or distribution of Licensed Products,
Net Sales will include the fair market value of such additional consideration.

      1.41      “Patent” will mean a patent or a patent application, including any additions, divisions,
continuations, continuations-in-part, invention certificates, substitutions, reissues,
reexaminations, extensions, registrations, supplementary protection certificates and renewals, but
not including any rights that give rise to Regulatory Exclusivity Periods (other than supplementary
protection certificates, which will be treated as “Patents” hereunder).

      1.42      “Patent Costs” will mean the out-of-pocket costs and expenses paid to outside legal
counsel and other Third Parties, and filing and maintenance expenses, incurred in Prosecuting and
Maintaining Patents and enforcing and defending them.

      1.43      “Phase 2 Study” will mean a clinical trial of a product, the principal purpose of which
is a determination of safety and efficacy in the target patient population, as described in 21
C.F.R. 312.21(b) (as amended or any replacement thereof), or a similar clinical study prescribed by
the Regulatory Authorities in a foreign country. For purposes of this Agreement, “start of Phase 2
Study” for a product will mean the first dosing of such product in a human patient in a Phase 2
Study.

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Amended and Restated Strategic License Agreement

      1.44      “Phase 3 Study” will mean a clinical trial of a product on a sufficient number of
subjects that is designed to establish that a pharmaceutical product is safe and efficacious for
its intended use, and to determine warnings, precautions, and adverse reactions that are associated
with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to
support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c) (as amended or any
replacement thereof), or a similar clinical study prescribed by the Regulatory Authorities in a
foreign country. For purposes of this Agreement, “start of Phase 3 Study” for a product will mean
the first dosing of such product in a human patient in a Phase 3 Study.

      1.45      “Prosecution and Maintenance,” with regard to a particular Patent, will mean the
preparation, filing, prosecution and maintenance of such Patent, as well as re-examinations,
reissues and the like with respect to that Patent, together with the conduct of interferences, the
defense of oppositions and other similar proceedings with respect to that Patent.

      1.46      “Regulatory Approval” will mean, with respect to a country or extra-national territory,
any and all approvals (including NDAs and MAAs), licenses, registrations or authorizations of any
Regulatory Authority necessary in order to commercially distribute, sell or market a product in
such country or some or all of such extra-national territory, but not including any pricing or
reimbursement approvals.

      1.47      “Regulatory Authority” will mean any national (e.g., the FDA), supra-national (e.g. the
EMA), regional, state or local regulatory agency, department, bureau, commission, council or other
governmental entity, in any jurisdiction in the world, involved in the granting of Regulatory
Approval.

      1.48      “Regulatory Exclusivity Period” will mean any period of data, market or other regulatory
exclusivity (other than supplementary protection certificates, which will be treated as Patents
hereunder), including any such periods under national implementations in the EU of Section
10.1(a)(iii) of Directive 2001/EC/83 and all international equivalents.

      1.49      “Research Candidates” will mean any covalent inhibitors that are designed, discovered or
tested as part of the Collaboration Program in an effort to discover and Develop a covalent
inhibitor to specifically inhibit the Targets with the properties specified in the Agreed Compound
Profile. For clarity, the Lead Candidate will be a “Research Candidate” hereunder.

      1.50      “Second Indication” will mean a disease condition for which a particular Licensed Product
may be prescribed, after such Licensed Product has already been approved by such Regulatory
Authority for the treatment of a first disease condition.

      1.51      “Selling Party” will mean Clovis and its Affiliates and Sublicensees, plus with respect
to sales or distribution of Licensed Products in or for the United States, Asia, Canada, the EU,
Norway and Switzerland, Distributors as well.

      1.52      “Sublicensee” will mean any person or entity (including Affiliates of Clovis) that is
granted a sublicense as permitted by Section 5.3(c) (or an option take such a sublicense), either
directly by Clovis or indirectly by any other Sublicensee hereunder.

      1.53      “Targets” will mean the mutant forms of the epidermal growth factor receptor specified on
Exhibit 1.53.

      1.54      “Third Party” will mean any person or entity other than Avila, Clovis and their
respective Affiliates.

      1.55      “United States” or “U.S.” will mean the United States of America, including its
territories and possessions, the District of Columbia and Puerto Rico.

      1.56      “Valid Claim” will mean, with respect to a particular country, (i) any claim of an issued
and unexpired Patent in such country that (a) has not been held permanently revoked, unenforceable
or invalid

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Amended and Restated Strategic License Agreement

by a decision of a court or governmental agency of competent jurisdiction, which decision is
unappealable or unappealed within the time allowed for appeal and (b) has not been abandoned,
disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or
otherwise in such country, or (ii) a claim of a pending Patent application, which claim is being
diligently prosecuted and has not been abandoned or finally disallowed without the possibility of
appeal or re-filing of the application.

Definitions for each of the following terms are found in the body of this Agreement as indicated
below:

	 	 	 	 	 	 

	 	Defined Term
	 	 	Location	 
	 	Additional Reporting Period
	 	 	Section 4.5	 
	 	Agreed Compound Profile
	 	 	Section 2.1(c)	 
	 	Agreement
	 	 	Preamble	 
	 	A&R Date
	 	 	Preamble	 
	 	Avila
	 	 	Preamble	 
	 	Avila Indemnitees
	 	 	Section 11.6(a)	 
	 	Avila Program Director
	 	 	Section 3.1	 
	 	Clovis
	 	 	Preamble	 
	 	Clovis Indemnitees
	 	 	Section 11.6(b)	 
	 	Clovis Program Director
	 	 	Section 3.1	 
	 	Collaboration Plan
	 	 	Section 2.1(b)	 
	 	Collaboration Program Term
	 	 	Section 2.1(c)	 
	 	Competitive Infringement
	 	 	Section 9.1	 
	 	Confidentiality Agreement
	 	 	Section 10.4	 
	 	Confidential Information
	 	 	Section 10.1(a)	 
	 	Cost Estimate
	 	 	Section 6.4(e)(i)	 
	 	Disclosing Party
	 	 	Section 10.1(a)	 
	 	Drug Company
	 	 	Section 13.3	 
	 	Effective Date
	 	 	Preamble	 
	 	Expert
	 	 	Section 13.1(d)(i)	 
	 	First Line Notice
	 	 	Section 6.4(e)(i)	 
	 	Hatch-Waxman Time Period
	 	 	Section 9.2(a)(iii)	 
	 	Indemnification Claim Notice
	 	 	Section 11.6(c)	 
	 	Indemnified Party
	 	 	Section 11.6(c)	 
	 	Industry Transaction
	 	 	Section 13.3	 
	 	Issuing Party
	 	 	Section 10.3(b)	 
	 	JAMS
	 	 	Section 13.1(c)	 
	 	Joint Collaboration Program IP
	 	 	Section 7.2(b)	 
	 	JSC
	 	 	Section 3.2(a)	 
	 	Losses
	 	 	Section 11.6(a)	 
	 	Milestone Event
	 	 	Section 6.3(a)	 
	 	Milestone Payment
	 	 	Section 6.3(a)	 
	 	Other Product
	 	 	Section 5.6	 
	 	Option Exercise Notice
	 	 	Section 6.4(e)(i)	 
	 	Original Agreement
	 	 	Preamble	 
	 	Other Patents
	 	 	Section 8.1	 
	 	Party and Parties
	 	 	Preamble	 
	 	Program Directors
	 	 	Section 3.1	 
	 	Receiving Party
	 	 	Section 10.1(a)	 
	 	Release
	 	 	Section 10.3(b)	 
	 	Reviewing Party
	 	 	Section 10.3(b)	 
	 

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Amended and Restated Strategic License Agreement

	 	 	 	 	 	 

	 	Defined Term
	 	 	Location	 
	 	Sole Collaboration Program IP
	 	 	Section 7.2(b)	 
	 	Specific Patent
	 	 	Section 8.1(b)	 
	 	Subject Patent
	 	 	Section 8.1	 
	 	Term
	 	 	Section 12.1	 
	 	Third Party Claims
	 	 	Section 11.6(a)	 
	 

2.          Collaboration Program.

      2.1       Collaboration Program Generally.

            (a)        Goals.   The objective of the Collaboration Program will be to discover and Develop
preclinically the Lead Candidate up to and through acceptance of an IND for the Lead Candidate, all
as directed by the JSC as provided herein.

            (b)        Collaboration Plan.   The research and preclinical Development activities of the Parties
with respect to the Collaboration Program will be described in a “Collaboration Plan,” an initial
version of which is attached hereto as Exhibit 2.1(b). The Collaboration Plan will include a
budget for the remaining portion of the Calendar Year in which this Agreement is executed and the
next succeeding Calendar Year, and a projected budget for the next Calendar Year thereafter or
until the end of the Collaboration Program Term if shorter. The Collaboration Plan will be
reviewed as necessary at each meeting of the JSC, and at any other time upon the request of either
Party, and will be modified as appropriate at the direction of the JSC to reflect material
scientific, commercial and other developments. In all events, the Collaboration Plan will be
consistent and not conflict with the terms of this Agreement.

            (c)        Designation of the Agreed Compound Profile and the Lead Candidate.   Attached hereto as
Exhibit 2.1(c) is the initial covalent inhibitor profile for the Targets, which will be used to
guide the discovery and Development of Research Candidates (the “Agreed Compound Profile”).
Pursuant to the Collaboration Plan, Avila will work to discover and Develop Research Candidates in
an effort to identify the Lead Candidate. The JSC will designate a Lead Candidate satisfying the
Agreed Compound Profile from among the Research Candidates, with reference to such other factors as
the JSC may deem relevant, including for example assessment of the complexity of chemical synthesis
of the Lead Candidate, expected amenability for manufacture of the Lead Candidate at scale,
physical forms of the Lead Candidate, physical stability of the Lead Candidate and the extent to
which strong patent Coverage could be obtained for such compound. If the JSC does not so designate
a Lead Candidate and an IND is not accepted for the Lead Candidate by July 1, 2012, then the
Parties will promptly meet and discuss the extent to which Clovis is willing to continue to fund
the Collaboration Program, and absent a commitment by Clovis to fund the Collaboration Program for
an additional period of time the Collaboration Program will terminate on October 1, 2012. The
Collaboration Program will be in effect for a period from the Effective Date until an IND is
accepted for the Lead Candidate unless ending earlier pursuant to the terms hereof (the
“Collaboration Program Term”).

            (d)        Obligations Under the Collaboration Plan.    Each Party will use reasonable efforts to
perform (itself or through its Affiliates or by permitted subcontracting) its respective
obligations under the Collaboration Plan, and will cooperate with and provide reasonable support to
the other Party in such other Party’s performance of its responsibilities under the Collaboration
Plan. The Parties acknowledge and agree, however, that no outcome or success is or can be assured
and that failure to achieve desired results will not in and of itself constitute a breach or
default of any obligation in this Agreement.

            (e)        Cell Lines.   Promptly following the execution of this Agreement and during the course of
the Collaboration Program Term, and subject to Section 2.2(c), Avila will share with Clovis cell
lines in its Control relevant to the Agreed Compound Profile as well as other relevant cell lines
developed as part of the Collaboration Program (e.g. Target transfectants/lines) and Controlled by
Avila to aid in

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Amended and Restated Strategic License Agreement

translational biology efforts for Research Candidates or the Lead Candidate or diagnostic
development efforts for Companion Diagnostics as part of the Clovis Development & Commercialization
Program.

            (f)        Pre-IND Regulatory Interactions.    Clovis will lead all efforts with Regulatory Authorities
regarding preclinical development of the Lead Candidate, including taking full responsibility for
preparing and filing the IND for the Lead Candidate and interactions with the FDA or other
Regulatory Authority regarding such IND or its equivalent.

      2.2        Collaboration Program Records, Reports and Materials.

            (a)        Records.    Each Party will maintain, or cause to be maintained, records of its activities
under the Collaboration Program in sufficient detail and in good scientific manner appropriate for
scientific, Patent and regulatory purposes, which will properly reflect all work included in the
Collaboration Program, Program for a period of at least ten (10) years after the creation of such
records. Each Party will have the right to request a copy of any such records, except to the
extent that the other Party reasonably determines that such records contain Confidential
Information that is not licensed to such Party hereunder, or to which such Party does not otherwise
have a right hereunder.

            (b)        Collaboration Program Reports.   During the Collaboration Program Term and for the next
calendar quarter thereafter, each Party will furnish to the JSC, a summary written report within
thirty (30) days after the end of each calendar quarter, describing its progress under the
Collaboration Plan as part of the Collaboration Program.

            (c)        Materials.

                   (i)        Each Party will, during the Collaboration Program Term, as a matter of course as described
in the Collaboration Plan or upon the other Party’s reasonable written request, furnish to each
other samples of Materials which constitute Avila Know-How or Clovis Technology in such Party’s
Control and are necessary for the other Party to carry out its responsibilities under the
Collaboration Plan.

                   (ii)       Each Party will use such Materials only in accordance with the Collaboration Plan and
otherwise in accordance with the terms and conditions of this Agreement. Except with the prior
written consent of the supplying Party, the Party receiving any Materials will not distribute or
otherwise allow the release of Materials to any Affiliate or Third Party, except for subcontracting
or to Sublicensees in each case as permitted hereunder. All Materials delivered to the receiving
Party will remain the sole property of the supplying Party and will be used in compliance with all
applicable law. The Materials supplied under this Agreement will be used with prudence and
appropriate caution in any experimental work because not all of their characteristics may be known.

      2.3        Permitted Subcontracting.    Each Party may subcontract any of its activities to be
performed under the Collaboration Plan to an Affiliate or Third Party, provided that any such
Affiliate or Third Party will have entered into a written agreement with such Party that includes
terms and conditions protecting and limiting use and disclosure of Confidential Information and
Materials and Know-How at least to the same extent as under this Agreement, and requiring such
Affiliate or Third Party and its personnel to assign to such Party all right, title and interest in
and to any Patents and Know-How and Materials created, conceived or reduced to practice in
connection with the performance of subcontracted activities. Any such subcontracting activities
will be described in the reports for the Collaboration Program required by Section 2.2(b).

3.        Governance.

     3.1      Management.     Management of the Collaboration Program activities will be under the
responsibility of one person to be designated by Clovis (the “Clovis Program Director”) and one
person to be designated by Avila (the “Avila Program Director,” and together with the Clovis
Program Director, the “Program Directors”).

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 Amended and Restated Strategic License Agreement

     3.2         Joint Steering Committee.

           (a)        Steering Committee.     As soon as practicable, the Parties will establish a Joint Steering
Committee, comprised of two (2) representatives of Avila and two (2) representatives of Clovis (the
“JSC”). Each Party may replace its representatives on the JSC or its Program Director at any time
upon written notice to the other Party. With the consent of the other Party (which will not be
unreasonably withheld or delayed), each Party may invite non-voting employees and consultants to
attend meetings of the JSC, subject to their agreement to be bound to the same extent as a
permitted subcontractor under Section 2.3.

           (b)        Meetings.     While in existence, the JSC will meet each calendar quarter and, at a minimum,
two of such meetings each Calendar Year will be in person (which in-person meeting will be held on
an alternating basis in Waltham, MA, on the one hand, and in either Boulder, CO or San Francisco,
CA, on the other). Meetings of the JSC will be effective only if at least one (1) representative
of each Party is present or participating. Each Party will be responsible for all of its own
expenses of participating in the committee meetings. The Parties will endeavor to schedule
meetings of the JSC at least six (6) months in advance. The Parties will alternate in preparing
the meeting agenda, and the Party that was responsible for preparing the meeting agenda will
prepare and circulate for review and approval by the other Party written minutes of such meeting
within fifteen (15) days after such meeting. The Parties will agree on the minutes of each meeting
promptly, but in no event later than the next meeting of the JSC.

           (c)        Responsibilities.    The JSC will oversee and supervise the overall performance of the
Collaboration Plan and within such scope will:

                 (i)        review the efforts of the Parties and allocate those resources for the Collaboration Plan
committed by the Parties hereunder;

                 (ii)        revise and approve any revised Collaboration Plan and its related budget regularly and in
any event at least thirty (30) days before the start of each Calendar Year during the Collaboration
Program Term;

                 (iii)       update the Agreed Compound Profile if and when appropriate during the Collaboration
Program Term;

                 (iv)        select Research Candidates for additional work as part of the Collaboration Program;

                 (v)        select the Lead Candidate as set forth in Section 2.1(c);

                 (vi)        form such other committees as the JSC may deem appropriate, provided that such committees
may make recommendations to the JSC but may not be delegated JSC decision-making authority;

                 (vii)      address such other matters relating to the activities of the Parties under this
Agreement as either Party may bring before the JSC, including any matters that are expressly for
the JSC to decide as provided in this Agreement; and

                 (viii)      attempt to resolve any disputes on an informal basis.

           (d)        Decision-making.    The two (2) JSC representatives of each Party will collectively have one
(1) vote, and the JSC will make decisions only by unanimous consent. In the event of a dispute
between the Parties with respect to the Collaboration Program or otherwise within the scope of the
JSC, the matter will be first considered by the JSC for resolution, and if not resolved, then
referred to the dispute resolution process set forth in Section 13.1(b); provided that instead of
escalation to such dispute resolution process, (i) Avila will have the tie-breaking vote for
matters involving the design, discovery and synthesis of Research Candidates and other research
chemistry aspects of the Collaboration Program, and (ii) Clovis will have the tie-breaking vote for
the selection of the Research Candidate meeting the

10

 

Amended and Restated Strategic License Agreement

Agreed Compound Profile that becomes the Lead Candidate hereunder and for matters involving
regulatory aspects of the IND for the Lead Candidate.

           (e)      Limits on JSC Authority.   Each Party will retain the rights, powers and discretion granted
to it under this Agreement and no such rights, powers, or discretion will be delegated to or vested
in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement
or the Parties expressly so agree in writing. The JSC will not have the power to amend, modify or
waive compliance with this Agreement (other than as expressly permitted hereunder).
Notwithstanding anything herein to the contrary, neither Party will require the other Party to
perform any activities that are materially different or greater in scope or more costly than those
provided for in the Collaboration Plan then in effect.

           (f)
     Term.    The JSC will cease to exist three (3) months after the end of the Collaboration
Program Term.

4.        Clinical Development and Commercialization.

      4.1      Clinical Development.  Upon the end of the Collaboration Program Term, Clovis will
assume sole responsibility for Developing the Lead Candidate and Licensed Products in the Field
worldwide, and will establish a Clovis Development & Commercialization Program for that purpose.
Clovis will have sole responsibility for all costs and expenses arising from the Development and
Commercialization of the Lead Candidate and Licensed Products in the Field worldwide.

      4.2      Regulatory.  Clovis will lead all efforts with Regulatory Authorities regarding
the Development and Commercialization of the Lead Candidate and Licensed Products in the Field
worldwide, including taking full responsibility for preparing and filing the relevant applications
for Regulatory Approval.

      4.3      Manufacturing.  Clovis will be solely responsible for, and will bear all the costs
and expenses of manufacturing and supplying all Licensed Products for Development and
Commercialization in the Field worldwide. Avila will provide at Clovis’ expense (including on an
FTE-basis) background research information and technical assistance as reasonably requested by
Clovis, to support development of the active drug substance for Licensed Products in the Field
worldwide.

      4.4      Clovis Diligence.  Clovis, directly or through one or more of its Affiliates,
Sublicensees or Distributors, will use Commercially Reasonable Efforts: (i) to Develop Licensed
Products in the Field and to obtain Regulatory Approvals therefor; and (ii) to Commercialize
Licensed Products in the Field after obtaining such Regulatory Approval, in the U.S., Canada, the
EU, Norway and Switzerland and in Asia, and in each other country worldwide where Commercializing
the Licensed Products would be Commercially Reasonable. Without limiting the generality of the
foregoing, Clovis will endeavor to complete an Asia Partnership within *** years after first human dosing
of any Licensed Product in a clinical trial, provided, that a failure to achieve such an Asia
Partnership within such time frame will have no contractual consequence other than the imposition
of the Japan-specific development Milestones Events specified in Section 6.3(d).

      4.5      Bi-Annual Update Meetings.  During each six (6)-month period from the end of the
Collaboration Program Term until the earlier of first approval of an NDA for any Licensed Product
by the FDA or first approval of an MAA for any Licensed Product by the EMA, within thirty (30) days
of Avila’s written request, the Parties will meet in person at a U.S. site of Clovis for Clovis to
provide Avila with an update on the Development of the Licensed Products by Clovis and its
Affiliates and Sublicensees. During such meeting, Clovis will disclose to Avila all material
information regarding such Development and will further provide such data and information in
writing with respect thereto as Avila may reasonably request. Each Party will bear its own costs
and expenses regarding such meetings. Further, in the event that Avila exercises its option under
Section 6.4(e) regarding cost sharing of certain clinical trial expenses, at Avila’s request such
meetings will occur, not only during the time period and at

11

 

Amended and Restated Strategic License Agreement

the frequency prescribed above, but also from Avila’s option exercise until twelve (12) months
after the completion of the additional clinical trial referred to in such Section 6.4(e) (the
“Additional Reporting Period”), and during the Additional Reporting Period such meetings will occur
each calendar quarter instead of once every six (6) months.

     4.6      Reports by Clovis.    Clovis will prepare and maintain, and will cause its
Affiliates, Sublicensees and Distributors to prepare and maintain, reasonably complete and accurate
records regarding the Development of Licensed Products, and Commercialization of Licensed Products
worldwide after Regulatory Approval therefor. Clovis will provide to Avila a reasonably detailed
report regarding such efforts at least once every two (2) calendar quarters. Such report will
contain sufficient detail to enable Avila to assess Clovis’s compliance with its Development and
Commercialization obligations in Section 4.4, including information with respect to the following:
(i) the design, status and results of any animal studies and clinical trials for the Lead Candidate
and Licensed Products; (ii) any regulatory milestones, and any Regulatory Approvals achieved, for
the Lead Candidate and Licensed Products; and (ii) activities with respect to selling, promoting,
supporting, detailing and marketing of Licensed Products. In addition to the foregoing, (a) Clovis
will provide Avila with such additional information regarding any such activities as Avila may
reasonably request from time to time, and (b) Clovis will disclose to Avila as soon as practicable
any information regarding any clinical trials for any Licensed Products that Clovis intends to
disclose publicly (after complying with the terms of this Agreement with respect thereto).
Further, in the event that Avila exercises its option under Section 6.4(e) regarding cost sharing
of certain clinical trial expenses, at Avila’s request such reports will be made by Clovis during
the Additional Reporting Period each calendar quarter instead of once every two (2) calendar
quarters.

5.      License Grants.

      5.1      Licenses by Avila

           (a)      For the Collaboration Program.   Subject to the terms and conditions of this Agreement,
Avila hereby grants to Clovis a worldwide, non-exclusive license, with the right to sublicense only
as permitted by Section 5.3, during the Collaboration Program Term, to use Avila Know-How and Avila
Patents, as needed to enable Clovis to perform its portion of the Collaboration Program.

           (b)      For Development and Commercialization.  Subject to the terms and conditions of this
Agreement, Avila hereby grants to Clovis a worldwide, exclusive (even as to Avila) license in the
Field, with the right to sublicense only as permitted by Section 5.3, under Avila Know-How and
Avila Patents, to Develop the Lead Candidate, Licensed Products and Companion Diagnostics and to
Commercialize Licensed Products and Companion Diagnostics, as part of a Clovis Development &
Commercialization Program, provided that until the first Regulatory Approval of a Licensed Product,
the foregoing license to Companion Diagnostics may only be used for the Development of Licensed
Products. For clarity, the license to Commercialize granted in this Section 5.1(b) will cover only
the sale and offer for sale of Licensed Products in finished form and Companion Diagnostics, and
not the sale or offer for sale of the Lead Candidate, API for Licensed Products, or any other
product or service other than Licensed Products in finished form and Companion Diagnostics.

      5.2      Licenses by Clovis.

           (a)      For the Collaboration Program.   Subject to the terms and conditions of this Agreement,
Clovis hereby grants to Avila a worldwide, non-exclusive license, with the right to sublicense only
as permitted by Section 5.3, during the Collaboration Program Term, to use Clovis Technology, as
needed to enable Avila to perform its portion of the Collaboration Program.

           (b)
     Grant-Back License.   Subject to the terms and conditions of this Agreement, Clovis hereby
grants to Avila a worldwide, fully paid-up, non-exclusive license, with the right to sublicense
through multiple tiers, to practice in full all Patents Controlled by Clovis or any of its
Affiliates and

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Amended and Restated Strategic License Agreement

Sublicensees claiming any invention conceived or reduced to practice as part of the
Collaboration Program or the Clovis Development & Commercialization Program (including all Patents
arising from any Collaboration Program Know-How) for manufacturing purposes only, except to the
extent and for such time that the claim scope of any such Patents Covers the Lead Candidate or
Licensed Products exclusively licensed by Avila to Clovis under Section 5.1(b). For clarity, the
license granted in this Section 5.2(b) will apply to Patents only, not Know-How.

      5.3         Sublicensing Rights.

            (a)        The licenses granted in this Section 5 are transferable only upon a permitted assignment
of this Agreement in accordance with Section 13.12.

            (b)        The licenses granted in Sections 5.1 and 5.2 may be sublicensed, in full or in part, by a
written agreement as may be necessary for permitted subcontracting hereunder as provided in Section
2.3.

            (c)        The license granted in Section 5.1(b) may be sublicensed, in full or in part, by Clovis by
a written agreement to its Affiliates and Third Parties (with the right to sublicense through
multiple tiers), provided, that as a condition precedent to and requirement of any such sublicense:

                 (i)        Clovis will consult with Avila when negotiating any sublicense for all or part of Asia,
including providing Avila with drafts of any proposed term sheets or agreements in sufficient time
for Avila to review and provide comments thereon, such comments to be taken into good faith
consideration by Clovis;

                 (ii)      Clovis will provide Avila with a copy of any sublicense agreement with a non-Affiliated
Sublicensee within thirty (30) days of execution thereof;

                 (iii)      Clovis will be responsible for any and all obligations of such Sublicensee as if such
Sublicensee were “Clovis” hereunder;

                 (iv)      Any such Sublicensee will agree in writing to be bound by similar obligations as “Clovis”
hereunder with respect to the activities of such Sublicensee hereunder (and not with respect to the
activities of any other); and

                 (v)      Avila will be made an express third-party beneficiary of any such Sublicensee’s
obligations under such sublicense agreement that relate to compliance with the terms and conditions
of this Agreement.

      5.4        Distributors. Subject to the terms and conditions of this Agreement, Clovis will
have the right to appoint by a written agreement Distributors to re-sell Licensed Products in
finished form purchased from or at the direction of Clovis, its Affiliates or Sublicensees. Clovis
will provide Avila with a copy of any agreement with any Distributor within thirty (30) days of
execution thereof. Clovis will be responsible for any and all obligations of any Distributor as if
such Distributor were “Clovis” hereunder. Further, any Distributor will agree in writing to be
bound by similar obligations as “Clovis” hereunder with respect to activities of such Distributor
in its jurisdiction under (i) Sections 4.4, 9.1, 10 and 11.6 and (ii) in addition, only for those
Distributors that are Selling Parties, Sections 4.6, 6.7(b) and 6.7(c).

      5.5        Contract Manufacturers. Subject to the terms and conditions of this Agreement,
Clovis will have the right to appoint by a written agreement “contract manufacturers”, meaning any
Third Party or Affiliate of Clovis that manufactures Licensed Products (or API therefor) for
re-sale, but who itself is not a “Sublicensee” hereunder and thereby exercises “have made” rights
granted by Avila under Section 5.1(b). Clovis will be responsible for any such contract
manufacturer hereunder, and further will require any such contract manufacturer to agree in writing
to comply with Sections 2.2(c), 5.7, and 10.

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 Amended and Restated Strategic License Agreement

       5.6        Exclusivity. During the Term (on a country-by-country basis), neither Avila nor
Clovis nor any of their Affiliates will intentionally Develop or commercialize ***, except as
contemplated under this Agreement; provided, however, that:

            (a)      with respect to a Party, the foregoing prohibition will not apply to such Party or any of
its Affiliates after the closing of an Industry Transaction of such Party, provided that ***;

            (b)      The Parties understand and agree that ***; and

            (c)      Notwithstanding anything herein to the contrary, Avila will retain the right to use alone
or with others the Lead Candidate and Licensed Products for cross-screening and analysis of
molecules against any targets to enable compliance with this Section 5.6.

       5.7        No Other Licenses or Rights.   No license or other right is or will be created or
granted hereunder by implication, estoppel or otherwise. All such licenses and rights are or will
be granted only as expressly provided in this Agreement.

6.        Payments and Royalties.

       6.1        Up-Front Payment.   Clovis will pay to Avila on the Effective Date a one-time
payment of Two Million Dollars (U.S.$2,000,000), which will be non-refundable and non-creditable
and not subject to set-off.

       6.2        Collaboration Program FTE Support and Expense Payments.

            (a)        Collaboration Program FTE Support.

                  (i)        During the Collaboration Program Term, as support for work performed by or on behalf of
Avila under the Collaboration Plan, Clovis will pay Avila for FTEs at the proportionate share of
the FTE Rate for each FTE related to the time devoted by such FTE to the Collaboration Program.
Avila will establish a time tracking system for its FTEs involved in the Collaboration Program,
under which each person for whom Avila will seek reimbursement from Clovis will specify on an
every-other-week basis what percentage of his or her working time is spent on the Collaboration
Program. Avila will use reasonable efforts to manage and monitor the time of its FTEs involved in
the Collaboration Program in relation to the budget for the then Calendar Year under the
Collaboration Plan as established under Section 2.1(b) and will promptly communicate through the
JSC if any adjustment is needed to such budget during the applicable Calendar Year.

                  (ii)        Promptly following the end of each calendar quarter during the Collaboration Program
Term, Avila will invoice Clovis for the FTEs time at the FTE Rate devoted during such quarter to
the Collaboration Program, and will provide with each such invoice a reasonably detailed
description of the proportionate share of his or her time devoted by each FTE. Clovis will pay
Avila within thirty (30) days of receiving such invoice any undisputed FTE charges. Section 6.7(c)
will apply to Avila and the FTE charges will be subject to audit by Clovis under the terms of that
Section 6.7(c).

            (b)        Payment for External Expenses.   Promptly following the end of each calendar quarter during
the Collaboration Program Term, Avila will invoice Clovis for external expenses incurred by Avila
in support of the Collaboration Program and in accordance with the budget under the Collaboration
Plan and Avila will provide with each such invoice a reasonably detailed description of such
expenditures, and thereafter Avila will provide Clovis with any materials supporting such
expenditures as Clovis may reasonably request. Clovis will pay Avila within thirty (30) days of
receiving such invoice any undisputed amounts of such external expenses. In addition to the
foregoing, if any such external expense is expected to exceed One Hundred Thousand Dollars
(U.S.$100,000) from any single vendor, Avila may request that Clovis pay such expense directly or
reimburse Avila in advance of Avila incurring such expense, and in connection therewith Avila will
promptly provide Clovis with any materials describing such expense as Clovis may reasonably
request. Section 6.7(c) will apply to Avila and such external expenses will be subject to audit by
Clovis under the terms of that Section 6.7(c).

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Amended and Restated Strategic License Agreement

       6.3        Milestone Payments.

          (a)        Generally.     Clovis will make milestone payments (each, a “Milestone Payment”) to Avila
upon the occurrence of each of the milestones events (each, a “Milestone Event”) as set forth below
in this Section 6.3. Each of the Milestone Payments will be payable to Avila by Clovis within ten
(10) days of the achievement of the specified Milestone Event, and such payments when owed or paid
will be non-refundable and non-creditable (except as specified in Section 6.3(b) for Milestone
Payments W and X, and in Section 6.3(d) for Milestone Payments A, B and C), and not subject to
set-off. Each of the Milestone Payments are payable only once.

          (b)        Development Milestones.

	 	 	 	 	 	 

	 	Milestone Event
	 	 	Milestone Payment	 
	 	
Upon the effectiveness of the first IND filing for Licensed Product
	 	 	Four Million Dollars (U.S.$4,000,000)	 
	 	
Upon start of the first Phase 2 Study for Licensed Product
	 	 	***	 
	 	

Upon acceptance of the filing of the first NDA in the United States or MAA in the EU for Licensed Product

a) First of the United States or EU 

b) Second of the United States or EU

 
	 	 	

***

***	 
	 	Upon the first approval of an NDA for Licensed
Product by the FDA
	 	 	
***	 
	 	Upon the first approval of an MAA for Licensed
Product by the EMA
	 	 	
***	 
	 	W. Upon start of the first Phase 3 Study (or, if
earlier, as such times as the first Phase 2 Study
is determined to be the pivotal study) for
Licensed Product in a Second Indication*
	 	 	
***	 
	 	X. Upon acceptance of the filing of an NDA in the
United States or MAA in the EU for Licensed
Product in a Second Indication*
	 	 	
***	 
	 	Upon the approval of an NDA for Licensed Product
by the FDA in a Second Indication
	 	 	
***	 
	 	Upon the approval of an MAA for Licensed Product
by the EMA in a Second Indication
	 	 	
***	 
	 

*If Avila elects to opt-in to pay certain Development costs and increase royalties payable
hereunder pursuant to Section 6.4(e), then Milestone Payment W is not thereafter payable
and Milestone Payment X is thereafter payable only at fifty percent (50%) of the amount
specified above (i.e., ***), or, if and to the extent either or both of Milestone Payments
W and X have been previously paid, may be credited by Clovis in the full amount of
Milestone Payment W and fifty percent (50%) of the amount specified above for Milestone
Payment X (i.e., ***) against the payment of future royalties or other Milestone Payments
hereunder.

If Milestone Event W or X concerning a Second Indication occurs before the Regulatory
Approval of Licensed Product for a first disease condition, then the payment of the
corresponding Milestone Payment will be due ten (10) days after Regulatory Approval of a
first disease condition for Licensed Product. For purposes of Milestones Payments, the
treatment of an approved indication as either “first” or “second” will ultimately be
determined by the actual

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Amended and Restated Strategic License Agreement

timing of the Regulatory Approval of the indication, even if such timing is the reverse of
that contemplated by the original designation of such indications by the Parties.

(c)      Sales Milestones.

	 	 	 	 	 	 

	 	Milestone Event	 	 	Milestone Payment	 
	 	Upon Net Sales in any Calendar Year arising from the
worldwide sale or distribution of all Licensed Products
exceeding *** for the first time
	 	 	***	 
	 	Upon Net Sales in any Calendar Year arising from the
worldwide sale or distribution of all Licensed Products
exceeding *** for the first time
	 	 	***	 
	 	Upon Net Sales in any Calendar Year arising from the
worldwide sale or distribution of all Licensed Products
exceeding *** for the first time
	 	 	***	 
	 

        (d)      Asia Milestones.    If Clovis does not enter into an exclusive Asia Partnership within ***
years after the first human dosing of a Licensed Product in a clinical trial, the following additional
Milestone Payments will be payable to Avila:

	 	 	 	 	 	 

	 	Milestone Event	 	 	Milestone Payment	 
	 	Start of a registration study for Japan for Licensed
Product (as such study is agreed with Japanese health
authorities)
	 	 	***	 
	 	Upon the filing of the first regulatory application for
Regulatory Approval in Japan of Licensed Product
	 	 	***	 
	 	Upon the first Regulatory Approval in Japan of Licensed
Product
	 	 	***	 
	 

If Clovis enters into such an Asia Partnership after any of the foregoing Milestone
Payments A, B or C are paid to Avila, any such Milestone Payments so paid to Avila will be
creditable against amounts owed Avila pursuant to Sections 6.4(a)(ii)(A) and 6.4(d) and
pursuant to Section 6.5 for such Asia Partnership, to reflect the equal sharing of
Financial Consideration contemplated by Section 6.5.

By way of example, (i) if Milestone Payment A has already been paid by Clovis to Avila, and
Clovis thereafter enters into such an Asia Partnership with a license fee of ***, then
fifty percent (50%) of such license fee, or ***, would have been owed Avila, and since
Clovis has already paid Avila *** as Milestone Payment A, then Clovis has a *** credit as
provided above, or (ii) if Milestone Payment A has already been paid by Clovis to Avila,
and Clovis thereafter enters into such an Asia Partnership with a license fee of ***, then
fifty percent (50%) of such license fee, or ***, would have been owed Avila, and since
Clovis has already paid Avila *** as Milestone Payment A, then Clovis owes Avila ***
payable in accordance with Section 6.7(a).

     6.4      Royalties.

         (a)      Royalties and Rates.

                (i)      Subject to the remainder of this Section 6.4, Clovis will pay to Avila running royalties
based on the total aggregate annual Net Sales worldwide by Selling Parties of all Licensed Products
in a given Calendar Year at the following royalty rates:

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Amended and Restated Strategic License Agreement

	 	 	 	 	 	 	 	 
	 
	 	Annual Worldwide Net Sales	 	 	Royalty Rate	 	 
	 	of all Licensed Products	 	 	 	 	 	 
	 	Up to ***
	 	 	 	***	 
	 	From *** up to ***
	 	 	 	***	 
	 	From *** up to ***
	 	 	 	***	 
	 	Over ***
	 	 	 	***	 
	 

By way of example, in a given Calendar Year, if the aggregate annual worldwide Net Sales for all
Licensed Products is ***.

               (ii)      Notwithstanding Section 6.4(a)(i), for all Net Sales invoiced after the date that Clovis
first enters into an Asia Partnership, this Section 6.4(a)(ii) will apply instead of Section
6.4(a)(i) for those later-invoiced Net Sales:

                    (A)      Asia Net Sales. Subject to the remainder of this Section 6.4, Clovis will pay to Avila
running royalties based on the total aggregate annual Net Sales for Asia by Selling Parties of all
Licensed Products in a given Calendar Year at the following royalty rates:

	 	 	 	 	 	 	 	 
	 
	 	Annual Net Sales for Asia	 	 	Royalty Rate	 	 
	 	of all Licensed Products	 	 	 	 	 	 
	 	Up to ***
	 	 	 	***	 
	 	From *** up to ***
	 	 	 	***	 
	 	From *** up to ***
	 	 	 	***	 
	 	Over ***
	 	 	 	***	 
	 

By way of example, in a given Calendar Year, if the aggregate annual Net Sales for Asia for all
Licensed Products is ***.

                    (B)      Non-Asia Net Sales. Subject to the remainder of this Section 6.4, Clovis will pay to
Avila running royalties based on the total aggregate annual Net Sales worldwide other than for Asia
by Selling Parties of all Licensed Products in a given Calendar Year at the following royalty
rates:

	 	 	 	 	 	 	 	 
	 
	 	Annual Net Sales Worldwide Other than for Asia	 	 	Royalty Rate	 	 
	 	of all Licensed Products	 	 	 	 	 	 
	 	Up to ***
	 	 	 	***	 
	 	From *** up to ***
	 	 	 	***	 
	 	From *** up to ***
	 	 	 	***	 
	 	Over ***
	 	 	 	***	 
	 

By way of example, in a given Calendar Year, if the aggregate annual worldwide Net Sales (other
than for Asia) for all Licensed Products is ***.

               (iii)      For clarity, and as applied to both Sections 6.4(a)(i) and 6.4(a)(ii), with respect to
sales or distribution of Licensed Products in or for the United States, Asia, Canada, the EU,
Norway and Switzerland by one or more Distributors (as opposed to Clovis or any of its Sublicensees
or Affiliates), royalties payable under this Section 6.4(a) will be based on Net Sales of such
Distributors (and not on sales of Licensed Products to such Distributor by or at the direction of
Clovis or any of its Affiliates or Sublicensees).

          (b)      Royalty Term. Royalties under Section 6.4(a) will be payable on the Net Sales of any
Licensed Product if at least one of the following three (3) conditions apply:

               (i)      if one or more Valid Claims within any of the Avila Patents Covers such Licensed Product;

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Amended and Restated Strategic License Agreement

                          (ii)        if one or more Regulatory Exclusivity Periods apply to the manufacture, use, sale, offer
for sale or importation of such Licensed Product; or

                         (iii)        on a country-by-country and Licensed Product-by-Licensed Product basis, for *** years from the
First Commercial Sale of such Licensed Product in such country.

                 (c)        Royalty Reduction for the United States. If a Licensed Product sold or distributed for
the United States is royalty-bearing only on account of Section 6.4(b)(iii), but not Section
6.4(b)(i) or 6.4(b)(ii), then the royalty rates set forth in Sections 6.4(a)(i) and 6.4(a)(ii)(B)
with respect to Net Sales attributable to such sales for the United States will be reduced by ***.
There will not be any other royalty deductions.

                 (d)        Royalty Adjustment for Asia. Upon Clovis first entering into an Asia Partnership, then
with respect to Net Sales invoiced thereafter from the sale or distribution of Licensed Products
for Asia attributable to any Sublicensee(s), royalties payable to Avila on such Net Sales will be
the greater of (i) *** or (ii) *** For each calendar quarter during which an Asia Partnership is
in effect, Clovis will determine the amounts payable to Avila under both of clause (i) and (ii)
based on the aggregate Net Sales from January 1 of the applicable Calendar Year until the end of
calendar quarter in question, and will pay to Avila the greater of those two amounts in accordance
with Section 6.7(b). Within ninety (90) days after the end of each Calendar Year during which an
Asia Partnership is in effect, Clovis will perform a “true-up” based on clauses (i) and (ii) above,
and will thereby pay Avila by the end of such 90-day period in accordance with Section 6.7(b) an
amount equal to (x) the greater of clause (i) or (ii) based on the full Calendar Year minus (y) the
sum of what Clovis had paid to Avila under either or both of clause (i) or (ii) for the first three
(3) calendar quarters of such Calendar Year. For clarity, if Clovis or any of its Affiliates or
Distributors (but not Sublicensees) sells or distributes Licensed Product for Asia after any such
Asia Partnership goes into effect, then Net Sales for Asia attributable to Clovis, its Affiliates
and Distributors will be included in Section 6.4(a)(ii)(A) for the royalties payable to Avila
hereunder, but will not be included in the “true-up” calculation required by this Section 6.4(d).

                 (e)        Royalty Buy-In Option.

                          (i)        At such time, if any, as Clovis decides to pursue the Regulatory Approval in either the
U.S. or EU for the use of a Licensed Product as a First Line Therapy, it will notify Avila of such
decision and provide Avila with a reasonable summary of the clinical Development plan which Clovis
is contemplating to achieve such Regulatory Approval and, ultimately, its counterpart Regulatory
Approval in the other major region (i.e., either the U.S. or EU), together with the cost estimates
(the “Cost Estimate”) for such a clinical Development program (the “First Line Notice”). Within
*** months following the delivery of the First Line Notice, Avila may exercise an option, by
delivery of notice to Clovis (the “Option Exercise Notice”) to pay *** of all costs incurred by
Clovis or any its Affiliates or Sublicensees in the Development effort required to achieve
Regulatory Approvals for such a First Line Therapy in the U.S. and EU, including both direct out of
pocket costs and the time of Clovis personnel devoted to the First Line Therapy Development effort,
charged on an FTE Rate basis in a manner comparable to that described in Section 6.2(a). The
Parties understand that the Development pathway for such Regulatory Approvals may be subject to
changes to meet demands of Regulatory Authorities or as a result of the need to modify clinical
trial design to conform to best medical practices or ethical considerations, or to add additional
clinical trials, and, accordingly, that the Cost Estimate provided by Clovis may well be exceeded.
If Avila exercises this option, then from and after the date of the first of such Regulatory
Approvals for a First Line Therapy, Clovis will pay Avila an additional royalty of *** on combined
annual Net Sales of Licensed Products for the U.S. and EU in excess of *** in a given Calendar
Year. This payment will be in addition to the royalties due Avila as set forth in Section 6.4(a),
and will be subject to all of the provisions of this Agreement relating to royalties (including the
remainder of this Section 6.4).

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 Amended and Restated Strategic License Agreement

                          (ii)        Clovis will invoice Avila each calendar quarter monthly for Avila’s share of the costs of
such First Line Therapy Development effort, with the first such invoice to be for the calendar
quarter in which the Option Exercise Notice is delivered by Avila, and Clovis will provide with
each such invoice a reasonably detailed description of those costs and thereafter Clovis will
provide Avila with any materials supporting those such costs as Avila may reasonably request.
Avila will pay Clovis within thirty (30) days of receiving such invoice Avila’s shares of any
undisputed costs. Section 6.7(c) will apply to Clovis and those costs for which Clovis asks Avila
to share, and those costs will be subject to audit by Avila under the terms of that Section 6.7(c).

                          (iii)        If the aggregate costs of such First Line Therapy Development effort ultimately exceed
the Cost Estimate by more than ***, then upon ninety (90) days advance written notice to Clovis
given at any time after such threshold has been exceeded, Avila may elect to no longer pay a ***
share of such costs (beginning with any such costs first accrued after such ninetieth
(90th) day). Upon such election by Avila, the *** additional royalty specified in
Section 6.4(e)(i) will be reduced on a pro rata basis to reflect Avila’s reduced share of such
costs, as follows: the *** in Section 6.4(e)(i) will be replaced with *** multiplied by the
fraction of (x) the amount actually paid by Avila for such Development costs, divided by (y) *** of
the aggregate of all such Development costs.

                 (f)          Additional Royalty Provisions. The royalties payable under Section 6.4(a) will be subject
to the following:

                          (i)        only one royalty will be payable hereunder with respect to each Licensed Product;

                         (ii)        royalties when owed or paid hereunder will, except as provided in Section 6.3(b), 6.3(d)
or 6.7(c), be non-refundable and non-creditable and not subject to set-off; and

                        (iii)        if a particular Licensed Product is sold or distributed in one country with the
intention of the Selling Party for use in one or more other countries, those other countries of
intended use as well as such country of sale will be treated as the countries of sale for purposes
of this Section 6.4. The Parties agree that the good faith estimate of such intended use by the
selling entity will be binding for such purposes.

       6.5      Other Sublicensee Consideration for Asia.     Clovis will pay to Avila fifty percent (50%) of all
Financial Consideration Clovis or any of its Affiliates receives in connection with any sublicense
agreement for all or part of Asia with any non-Affiliated Sublicensees concerning the Lead
Candidate or any Licensed Products, subject to any permitted credits taken pursuant to Section
6.3(d). Any such payments to Avila will be due within ten (10) days following receipt of any such
Financial Consideration.

       6.6      Other Distributor Consideration.     Clovis will pay to Avila fifty percent (50%) of all Financial
Consideration Clovis or any of its Affiliates receives in connection with any distributor agreement
with any Distributors concerning any Licensed Products. Any such payments to Avila will be due
within ten (10) days following receipt of any such Financial Consideration.

       6.7        Payment Terms.

                 (a)        Manner of Payment. All payments to be made by Clovis hereunder will be made in U.S.
dollars by wire transfer to such bank account as Avila may designate.

                 (b)      Reports and Royalty Payments.     For as long as royalties or other payments are due under
this Section 6, Clovis will furnish to Avila a written report, after the end of each calendar
quarter, showing the amount of Net Sales and royalty due, Financial Consideration and corresponding
sublicensing payments owed under Section 6.5, and any other payments accrued during such calendar
quarter, which report will be furnished within sixty (60) days of the end of the quarter for Net
Sales generated by Clovis and its Affiliates, and within ninety (90) days of the end of the quarter
for Net Sales generated by Sublicensees and Distributors. Royalty and other payments for each
calendar quarter will be due at the same time as such written reports for the calendar quarter.
The reports will include, at a

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Amended and Restated Strategic License Agreement

minimum, the following information for the applicable calendar quarter, each listed on a
Licensed Product-by-Licensed Product basis, and by country of sale or intended use: (i) the gross
amount received for such sales by the Selling Parties; (ii) deductions taken from Net Sales as
specified in the definition thereof, itemized by type and amount; (iii) Net Sales; (iv) royalties
owed Avila hereunder, payments under Section 6.5, Milestone Payments, any credits under Section
6.3(d), and other payments owed to Avila or already paid during such calendar quarter, listed by
category; (vi) any royalty adjustments under Sections 6.4(c), 6.4(d), or 6.4(f)(iii); (vii) any
amounts paid to Clovis by Sublicensees under clause (ii) of Section 6.4(d) and any true-up required
by Section 6.4(d); and (viii) the computations for any applicable currency conversions pursuant to
Section 6.7(c).

           (c)      Records and Audits.   Clovis will keep, and will cause each of the other Selling Parties,
as applicable, to keep, and Avila will keep, adequate books and records of accounting for the
purpose of calculating all royalties and other amounts payable by either Party to the other Party
hereunder and ensuring each Party’s compliance hereunder. For the three (3) years following the
end of the Calendar Year to which each will pertain, such books and records of accounting
(including those of the other Selling Parties, as applicable) will be kept at each of their
principal place of business. At the request of either Party, the other Party will, and, with
respect to Clovis, Clovis will cause each of the other Selling Parties to, permit the requesting
Party and its representatives (including an independent auditor), at reasonable times and upon
reasonable notice, to examine the books and records maintained pursuant to Section 6.2, 6.4(e) or
6.7(b). Such examinations may not (i) be conducted for any Calendar Year more than three (3) years
after the end of such year, (ii) be conducted more than once in any twelve (12) month period or
(iii) be repeated for any Calendar Year. Except as provided below, the cost of this examination
will be borne by the Party that requested the examination, unless the audit reveals a variance of
more than five percent (5%) from the reported amounts, in which case the audited Party will bear
the cost of the audit. Unless disputed as described below, if such audit concludes that additional
payments were owed or that excess payments were made during such period, the paying Party will pay
the additional royalties or amounts or the receiving Party will reimburse such excess payments,
with interest from the date originally due as provided in Section 6.7(g), within sixty (60) days
after the date on which a written report of such audit is delivered to the Parties. In the event
of a dispute regarding such books and records, including the amount of royalties owed to Avila
under this Section 6.7(c) or the calculation costs, expenses or FTE charges, Avila and Clovis will
work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually
acceptable resolution of any such dispute within thirty (30) days, such dispute will be resolved in
accordance with Section 13.1(d). The receiving Party will treat all information subject to review
under this Section 6.7(c) in accordance with the confidentiality provisions of Section 10 and the
Parties will cause any auditor or arbitrator to enter into a reasonably acceptable confidentiality
agreement with the audited Party obligating such firm to retain all such financial information in
confidence pursuant to such confidentiality agreement.

           (d)      Currency Exchange.   With respect to Net Sales invoiced in U.S. dollars, the Net Sales and
the amounts due to Avila hereunder will be expressed in U.S. dollars. With respect to Net Sales
invoiced in a currency other than U.S. dollars, payments will be calculated based on currency
exchange rates for the calendar quarter for which remittance is made for royalties. For each month
and each currency, such exchange rate will equal the arithmetic average of the daily exchange rates
(obtained as described below) during such calendar quarter; each daily exchange rate will be
obtained from www.OANDA.com or, if not so available, as otherwise agreed by the Parties. For
purposes of calculating the Net Sales thresholds set forth in Sections 6.3(c) and 6.4(a), the
aggregate Net Sales with respect to each calendar quarter within a Calendar Year will be calculated
based on the currency exchange rates for the calendar quarter in which such Net Sales occurred, in
a manner consistent with the exchange rate procedures set forth in the immediately preceding
sentence.

           (e)      Taxes.   Clovis may withhold from payments due to Avila amounts for payment of any
withholding tax that is required by law to be paid to any taxing authority with respect to such
payments.

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Amended and Restated Strategic License Agreement

Clovis will provide Avila all relevant documents and correspondence, and will also provide to
Avila any other cooperation or assistance on a reasonable basis as may be necessary to enable Avila
to claim exemption from such withholding taxes and to receive a refund of such withholding tax or
claim a foreign tax credit. Clovis will give proper evidence from time to time as to the payment
of any such tax. The Parties will cooperate with each other in seeking deductions under any double
taxation or other similar treaty or agreement from time to time in force. Such cooperation may
include Clovis making payments from a single source in the U.S., where possible. Apart from any
such permitted withholding and those deductions expressly included in the definition of Net Sales,
the amounts payable Clovis to Avila hereunder will not be reduced on account of any taxes, charges,
duties or other levies.

           (f)        Blocked Payments.   In the event that, by reason of applicable law in any country, it
becomes impossible or illegal for Clovis (or any other Selling Party) to transfer, or have
transferred on its behalf, payments owed Avila hereunder, Clovis will promptly notify Avila of the
conditions preventing such transfer and such payments will be deposited in local currency in the
relevant country to the credit of Avila in a recognized banking institution designated by Avila or,
if none is designated by Avila within a period of thirty (30) days, in a recognized banking
institution selected by Clovis or another Selling Party, as the case may be, and identified in a
written notice given to Avila.

           (g)        Interest Due.   If any payment due to either Party under this Agreement is overdue (and is
not subject to a good faith dispute), then such paying Party will pay interest thereon (before and
after any judgment) at an annual rate (but with interest accruing on a daily basis) of the lesser
of two percent (2%) above the prime rate as reported in The Wall Street Journal, Eastern Edition,
and the maximum rate permitted by applicable law, such interest to run from the date upon which
payment of such sum became due until payment thereof in full together with such interest.

     6.8        Mutual Convenience of the Parties.    The royalty and other payment obligations set
forth hereunder have been agreed to by the Parties for the purpose of reflecting and advancing
their mutual convenience, including the ease of calculating and paying royalties and other amounts
to Avila. Clovis hereby stipulates to the fairness and reasonableness of such royalty and other
payments obligations and covenants not to allege or assert, nor to allow any of its Sublicensees,
Affiliates or Distributors to allege or assert, nor further to cause or support any other Third
Parties to allege or assert, that any such royalty or other payments obligations are unenforceable
or illegal in any way.

7.        Ownership of Collaboration Program Know-How.

     7.1      Disclosure of Collaboration Program Know-How. Each Party will promptly (and at
least on a calendar quarterly basis) disclose to the other Party any Collaboration Program Know-How
created, conceived or reduced to practice by or on behalf of such Party, and will provide such
documentation regarding same as such other Party may reasonably request.

     7.2      Ownership and Inventorship.

           (a)        Avila Owned IP. As between the Parties, Avila will solely own all right, title and
interest in and to the Avila Owned IP, and all right, title and interest in and to all Avila Owned
IP will automatically vest solely in Avila. Clovis, for itself and on behalf of its Affiliates and
subcontractors, and employees, subcontractors, consultants and agents of any of the foregoing,
hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to
assign), to Avila all right, title and interest in and to Avila Owned IP (unless already owned by
Avila). Clovis will cooperate, and will cause the foregoing persons and entities to cooperate,
with Avila to effectuate and perfect the foregoing ownership, including by promptly executing and
recording assignments and other documents consistent with such ownership.

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Amended and Restated Strategic License Agreement

           (b)      Sole and Joint Collaboration Program Know-How.

                (i)      Except for any Avila Owned IP, ownership of any Collaboration Program Know-How, and
Patents arising therefrom, created, conceived or reduced to practice solely by or on behalf of a
Party will be solely owned by such Party (referred to herein along with all Patents arising
therefrom, as “Sole Collaboration Program IP” for each Party), and if created, conceived or reduced
to practice jointly by or on behalf of the Parties will be jointly owned by the Parties (referred
to herein along with all Patents arising therefrom, as “Joint Collaboration Program IP”).

                (ii)      Each Party will have an undivided one-half interest in and to Joint Collaboration Program
IP. Each Party will exercise its ownership rights in and to such Joint Collaboration Program IP,
including the right to license and sublicense or otherwise to exploit, transfer or encumber its
ownership interest, without an accounting or obligation to, or consent required from, the other
Party, but subject to the licenses hereunder and the other terms and conditions of this Agreement.
At the reasonable written request of a Party, the other Party will in writing grant such consents
and confirm that no such accounting is required to effect the foregoing regarding Joint
Collaboration Program IP. Each Party, for itself and on behalf of its Affiliates, licensees and
sublicenses, and employees, subcontractors, consultants and agents of any of the foregoing, hereby
assigns (and to the extent such assignment can only be made in the future hereby agrees to assign),
to the other Party a joint and undivided interest in and to all Joint Collaboration Program IP.

                (iii)      Subject to the licenses hereunder and the other terms and conditions of this Agreement
(including Section 8 and 9):

                     (A)      Each Party will be solely responsible for the Prosecution and Maintenance, and the
enforcement and defense, of any Patents within its Sole Collaboration Program IP, and the other
Party will have no rights with respect thereto; and

                     (B)      The Prosecution and Maintenance, and the enforcement and defense, of any Patents within
Joint Collaboration Program IP will be jointly managed by the Parties on mutually agreeable terms
to be entered into by the Parties at the time any such Patents are first filed, and all recoveries
and out-of-pocket costs and expenses arising from those activities, absent further agreement, will
be shared equally by the Parties (provided that sufficient advance written notice of any such costs
or expenses is given to the Party not incurring same), provided that if either Party elects not to
pay any such costs or expenses for any such Patent, the Parties will meet and agree upon an
equitable way to treat such Patent.

           (c)      Inventorship.   Inventorship determination for all Patents worldwide arising from any
Collaboration Program Know-How and thus the ownership thereof will be made in accordance with
applicable United States patent laws.

8.        Patent Prosecution and Maintenance.

     8.1      Subject Patents.   The following provisions of this Section 8.1 will apply to Avila
Patents when subject to the exclusive licenses in Section 5.1(b), and then only with respect to the
scope of such exclusive license (each such Avila Patent, only when so subject, a “Subject Patent”).
Other than for Subject Patents hereunder, all Avila Patents will be referred to herein as “Other
Patents”.

           (a)      Prosecution and Maintenance.    Avila will have the sole right to Prosecute and Maintain
throughout the world the Subject Patents, and will retain final decision making authority with
respect thereto, except as set out in the remainder of this Section 8. Avila will regularly
provide Clovis with copies of all Subject Patent applications, and all other material submissions
and correspondence with any patent authorities regarding Subject Patents, in sufficient time to
allow for review and comment by Clovis, and Avila will consider in good faith all such comments
timely made. More specifically, as of the A&R Date the Parties have agreed to pursue the
Prosecution and Maintenance activities set forth on

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Amended and Restated Strategic License Agreement

Exhibit 8.1(a). Except as set forth in Section 8.1(b) for Specific Patents or Section 8.1(c)
or Exhibit 8.1(a), Avila will be responsible for all Patent Costs incurred by Avila for Subject
Patents.

           (b)        Specific Patents.   For any Subject Patent having a specification that could reasonably
support and enable a composition-of-matter claim or a method-of-use claim in each case Covering
only the Lead Candidate or a particular Licensed Product, the following will apply: to the extent
practicable, upon Clovis’s reasonable written request and provided that Avila reasonably agrees
with Clovis that the following Prosecution and Maintenance activities would not materially harm any
other Avila Patents or other Patents owned by Avila or any of its Affiliates, the Parties will file
a U.S. continuation, continuation-in-part or divisional of such Subject Patent application seeking
issuance of such composition-of-matter or method-of-use claim scope (and no other claim scope)
(each such Subject Patent, a “Specific Patent”). Each such Specific Patent will remain a “Subject
Patent” hereunder, so that this Agreement will continue to apply thereto, provided that the Parties
will jointly control the Prosecution and Maintenance thereof using patent counsel selected by
Avila, and Clovis will be solely responsible for the payment of all related Patent Costs. Neither
Party may take any action with respect to the Prosecution or Maintenance of any Specific Patent
without the consent of the other Party, such consent not to be unreasonably withheld or delayed.
If and at such time as Clovis no longer has an exclusive license to all of the claim scope of any
such Specific Patent, then any such Specific Patent will no longer be treated as such hereunder
(although it may remain a Subject Patent). Clovis acknowledges and agrees that Avila may grant
substantially similar rights to other exclusive Third Party licensees under any Subject Patents.

           (c)        Election Not to Prosecute or Maintain or Pay Patent Costs.   If Avila elects not (i) to
Prosecute or Maintain any Subject Patent in any particular country before the applicable filing
deadline or continue such activities once filed in a particular country, or (ii) to pay the Patent
Costs associated with Prosecution or Maintenance of any Subject Patent, then in each such case
Avila will so notify Clovis, promptly in writing and in good time to enable Avila to meet any
deadlines by which an action must be taken to preserve such Subject Patent in such country, if
Clovis so requests. Upon receipt of each such notice by Avila, Clovis will have the right, but not
the obligation, to notify Avila in writing on a timely basis that Avila should continue the
Prosecution or Maintenance of such Subject Patent on the terms set forth above, and Clovis will
reimburse Avila for all Patent Costs thereafter incurred by Avila with respect thereto within
thirty (30) days of receiving an invoice therefor. If after making such election, Clovis elects
not to pay the Patent Costs associated with Prosecution or Maintenance of any Subject Patent, then
in each such case Clovis will so notify Avila and on the ninetieth (90th) day after
Avila’s receipt of such notice such Subject Patent will no longer be licensed to Clovis hereunder
and will not longer be treated as a “Subject Patent” hereunder. Clovis will be required to
reimburse Avila for Patent Costs for such Subject Patent incurred by Avila through such ninetieth
(90th) day, but not thereafter.

           (d)        Patent Term Extensions and Filings for Regulatory Exclusivity Periods.

                  
(i)     Avila will consult with Clovis when considering any patent term restoration or
supplemental protection certificates or their equivalent for the Subject Patents. In the event
that any election with respect to patent term restoration or supplemental protection certificates
or their equivalent for any Subject Patent is available, Avila will decide on whether or not to
make any such election, provided that Clovis will have the right to decide whether or not to make
any such election with respect to any Specific Patents.

                   (ii)      With respect to any Patent listings required for any Regulatory Exclusivity Periods for
Licensed Products, the Parties will mutually agree on which Avila Patents to list.

     8.2        Other Licensed Patents.     Avila will have the sole right, and sole responsibility
for all Patent Costs incurred by Avila, to Prosecute and Maintain all Other Patents, and Clovis
will have no rights with respect thereto. Clovis will have the sole right, and sole responsibility
for all Patent Costs incurred by

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Amended and Restated Strategic License Agreement

Clovis, to Prosecute and Maintain all Patents within Clovis Technology, and Avila will have no
rights with respect thereto.

     8.3      Cooperation.    Each Party will reasonably cooperate with the other Party in the
Prosecution and Maintenance of the Subject Patents and any other Patents within each Party’s Sole
Collaboration Program IP and within Joint Collaboration Program IP. Such cooperation includes
promptly executing all documents, or requiring inventors, subcontractors, employees and consultants
and agents of Clovis and its Affiliates, Sublicensees and Distributors to execute all documents, as
reasonable and appropriate so as to enable the Prosecution and Maintenance of any such Patents in
any country.

     8.4      Patent Marking.    Clovis will mark, and will cause all other Selling Parties to
mark, Licensed Products with all Avila Patents in accordance with applicable law, which marking
obligation will continue for as long as (and only for as long as) required under applicable law.

9.        Patent Enforcement and Defense.

     9.1      Notice.   Each Party will promptly notify, in writing, the other Party upon
learning of any actual or suspected Competitive Infringement of any Subject Patents by a Third
Party, or of any claim of invalidity, unenforceability, or non-infringement of any Subject Patents,
and will, along with such notice, supply the other Party with any evidence in its possession
pertaining thereto. For purposes of this Agreement, “Competitive Infringement” will mean any
allegedly infringing activity with respect to a Subject Patent, which activity (i) falls within the
scope then in effect of the licenses granted by Avila to Clovis as set forth in Sections 5.1(b),
and (ii) is reasonably expected to reduce the Net Sales of any Licensed Products.

     9.2  Enforcement and Defense.

          (a)      Subject Patents and Competitive Infringement.

                 (i)      As between the Parties, and subject to Section 9.2(a)(ii), Clovis will have the first
right, but not the obligation, to seek to abate any Competitive Infringement of the Subject Patents
by a Third Party, or to file suit against any such Third Party for such Competitive Infringement.
If Clovis does not take steps to abate such Competitive Infringement, or file suit to enforce the
Subject Patents against such Third Party with respect to such Competitive Infringement, within a
commercially reasonably time (and in all events within the applicable Hatch-Waxman Time Period, as
defined below), then subject to Section 9.2(a)(ii), Avila will have the right (but not the
obligation) to take action to enforce the Subject Patents against such Third Party for such
Competitive Infringement. The controlling Party will pay all its Patent Costs incurred for such
enforcement.

                 (ii)      Neither Party will exercise any of its enforcement rights under this Section 9.2(a)
without first consulting with the other Party, provided that this consultation requirement will not
limit either Party’s rights under this Section 9.2(a), and further provided that notwithstanding
anything herein to the contrary, Clovis will have no right to enforce (including seeking to abate
any Competitive Infringement) or defend any Subject Patent (other than, for clarity, any Specific
Patents) that Covers any compound that is in Development or has been commercialized by Avila, its
Affiliates, or any licensees or sublicensees of Avila and its Affiliates.

                (iii)      For purposes of this Agreement, “Hatch-Waxman Time Period” will mean the applicable
period of time during which a patent holder or licensee has the right to file an infringement suit
to maintain certain rights and privileges upon receipt of Paragraph IV Patent Certification by a
Third Party filing an Abbreviated New Drug Application or an application under §505(b)(2) of the
United States Food, Drug, and Cosmetic Act, as amended or any replacement thereof or any other
similar Patent certification by a Third Party, or any foreign equivalent thereof.

          (b)      Defense.   As between the Parties, Avila will have the first right, but not the obligation,
to defend against a declaratory judgment action or other action challenging any Subject Patents,
other than

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Amended and Restated Strategic License Agreement

with respect to (i) any interferences, oppositions, reissues or reexaminations, which are
included in the definition of Prosecution and Maintenance and addressed in Section 8, (ii) any
counter-claims in any enforcement action brought by Clovis pursuant to Section 9.2(a), or (iii) any
action by a Third Party in response to an enforcement action brought by Clovis alleging
infringement of any Subject Patents, which defense for the foregoing clause (ii) and this clause
(iii) will be controlled by the Party controlling such enforcement action (unless the last proviso
of Section 9.2(a)(ii) applies, in which case in all events Avila will control). If Avila does not
take steps to defend within a commercially reasonably time, or elects not to continue any such
defense, then ), then subject to Section 9.2(a)(ii), Clovis will have the right (but not the
obligation) to defend any such Subject Patent.

           (c)      Withdrawal, Cooperation and Participation. With respect to any infringement or defensive
action identified above in this Section 9.2:

                (i)    If the controlling Party ceases to pursue or withdraws from such action, it will notify
the other Party and then, subject to Section 9.2(a)(ii), such other Party may substitute itself for
the withdrawing Party and proceed under the terms and conditions of this Section 9.2.

                (ii)   The non-controlling Party will cooperate with the Party controlling any such action (as
may be reasonably requested by the controlling Party), including (i) providing access to relevant
documents and other evidence, (ii) making its and its Affiliates and licensees and sublicensees and
all of their respective employees, subcontractors, consultants and agents available at reasonable
business hours and for reasonable periods of time, but only to the extent relevant to such action,
and (iii) if necessary, by being joined as a party, subject for this clause (iii) to the
controlling Party agreeing to indemnify such non-controlling Party for its involvement as a named
party in such action and paying those Patent Costs incurred by such Party in connection with such
joinder. The Party controlling any such action will keep the other Party updated with respect to
any such action, including providing copies of all documents received or filed in connection with
any such action.

                (iii) Each Party will have the right to participate or otherwise be involved in any such
action controlled by the other Party, in each case at the participating Party’s sole cost and
expense. If a Party elects to so participate or be involved, the controlling Party will provide
the participating Party and its counsel with an opportunity to consult with the controlling Party
and its counsel regarding the prosecution of such action (including reviewing the contents of any
correspondence, legal papers or other documents related thereto), and the controlling Party will
take into account reasonable requests of the participating Party regarding such enforcement or
defense.

           (d)     Settlement.     Clovis may not settle or consent to an adverse judgment in any action
described in this Section 9.2 and controlled by Clovis, including any judgment which affects the
scope, validity or enforcement of any Subject Patents involved therewith, without the prior written
consent of Avila (such consent not to be unreasonably withheld or delayed).

          
(e)     Damages.     Unless otherwise agreed by the Parties, all monies recovered upon the final
judgment or settlement of any action described in Section 9.2(a), or any action described in
Section 9.2(b), will be used first to reimburse each of the Parties, and any other Third Party
licensees of Avila, on a pro rata basis for each of their out-of-pocket costs and expenses relating
to the action, with the balance of any such recovery to be divided as follows:

                (i)      To the extent the recovery reflects lost profits damages, if Clovis was the controlling
Party, Clovis will retain such lost profits recovery, less the amount of royalties payable to Avila
by treating such lost profits recovery as “Net Sales” hereunder, and if Avila was the controlling
Party, *** to Avila and *** to Clovis;

                (ii)      To the extent the recovery reflects reasonable royalty damages, if Clovis was the
controlling Party, *** to Clovis and *** to Avila, and if Avila was the initiating party, ***to
Avila and *** to Clovis; and

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 Amended and Restated Strategic License Agreement

          (iii)      For the remainder of any such recovery, *** to Clovis and *** to Avila.

     9.3      Other Patents.    Avila will have the sole right, and sole responsibility for all
Patent Costs incurred by Avila, to enforce and defend all Other Patents, and Clovis will have no
rights with respect thereto. Clovis will have the sole right, and sole responsibility for all
Patent Costs incurred by Clovis, to enforce and defend all Patents within Clovis Technology, and
Avila will have no rights with respect thereto.

10.      Confidentiality.

     10.1      Confidential Information.

           (a)      Confidential Information.    Each Party (“Disclosing Party”) may disclose to the other Party
(“Receiving Party”), and Receiving Party may acquire during the course and conduct of activities
under this Agreement, certain proprietary or confidential information of Disclosing Party in
connection with this Agreement. The term “Confidential Information” will mean (i) all Materials
and (ii) all ideas and information of any kind, whether in written, oral, graphical,
machine-readable or other form, whether or not marked as confidential or proprietary, which are
transferred, disclosed or made available by Disclosing Party or at the request of Receiving Party,
including any of the foregoing of Third Parties. Without limiting the foregoing, Avila Core
Technology and Avila Know-How will be considered Confidential Information of Avila, and Clovis
Technology will be considered Confidential Information of Clovis.

          (b)      Restrictions.    During the Term and for ten (10) years thereafter, Receiving Party will
keep all Disclosing Party’s Confidential Information in confidence with the same degree of care
with which Receiving Party holds its own confidential information. Receiving Party will not use
Disclosing Party’s Confidential Information except for in connection with the performance of its
obligations and exercise of its rights under this Agreement. Receiving Party has the right to
disclose Disclosing Party’s Confidential Information without Disclosing Party’s prior written
consent, to the extent and only to the extent reasonably necessary, to Receiving Party’s Affiliates
and their employees, subcontractors, consultants or agents who have a need to know such
Confidential Information in order to perform its obligations and exercise its rights under this
Agreement and who are required to comply with the restrictions on use and disclosure in this
Section 10.1(b). Receiving Party will use diligent efforts to cause those entities and persons to
comply with the restrictions on use and disclosure in this Section 10.1(b). Receiving Party
assumes responsibility for those entities and persons maintaining Disclosing Party’s Confidential
Information in confidence and using same only for the purposes described herein.

           (c)      Exceptions.    Receiving Party’s obligation of nondisclosure and the limitations upon the
right to use the Disclosing Party’s Confidential Information will not apply to the extent that
Receiving Party can demonstrate that the Disclosing Party’s Confidential Information: (i) was
known to Receiving Party or any of its Affiliates prior to the time of disclosure; (ii) is or
becomes public knowledge through no fault or omission of Receiving Party or any of its Affiliates;
(iii) is obtained by Receiving Party or any of its Affiliates from a Third Party under no
obligation of confidentiality to Disclosing Party; or (iv) has been independently developed by
employees, subcontractors, consultants or agents of Receiving Party or any of its Affiliates
without the aid, application or use of Disclosing Party’s Confidential Information, as evidenced by
contemporaneous written records.

           (d)      Permitted Disclosures.    Receiving Party may disclose Disclosing Party’s Confidential
Information to the extent (and only to the extent) such disclosure is reasonably necessary in the
following instances:

                (i)      in order to comply with applicable law (including any securities law or regulation or the
rules of a securities exchange) or with a legal or administrative proceeding;

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Amended and Restated Strategic License Agreement

                (ii)      in connection with prosecuting or defending litigation, Regulatory Approvals and other
regulatory filings and communications, and filing, prosecuting and enforcing Patents in connection
with Receiving Party’s rights and obligations pursuant to this Agreement; and

                (iii)      in connection with exercising its rights hereunder, to its Affiliates; potential and
future collaborators (including Sublicensees and Distributors where Clovis is the Receiving Party);
permitted acquirers or assignees; and investment bankers, investors and lender;

provided that (1) with respect to Sections 10.1(d)(i) or 10.1(d)(ii), where reasonably possible,
Receiving Party will notify Disclosing Party of Receiving Party’s intent to make any disclosure
pursuant thereto sufficiently prior to making such disclosure so as to allow Disclosing Party
adequate time to take whatever action it may deem appropriate to protect the confidentiality of the
information to be disclosed, and (2) with respect to Section 10.1(d)(iii), each of those named
people and entities are required to comply with the restrictions on use and disclosure in Section
10.1(b) (other than investment bankers, investors and lenders, which must be bound prior to
disclosure by commercially reasonable obligations of confidentiality).

     10.2      Publications.   The Parties intend to publish in scientific journals and present
at scientific conferences the results of the Collaboration Program, subject to the following
process. Notwithstanding anything to the contrary herein, either Party may propose publication of
the results of the Collaboration Program following scientific review by the JSC (if in force) and
subsequent written approval by Avila’s and Clovis’s management, which approval will not be
unreasonably withheld. After receipt of the proposed publication by both Clovis’s and Avila’s
management’s, such written approval or disapproval will be provided within thirty (30) days. Both
Parties understand that a reasonable commercial strategy may require delay of publication of
information or filing of patent applications, therefore the Parties agree to review and consider
delay of publication and filing of patent applications under certain circumstances for a reasonably
limited period of time. Once publications have been reviewed by each Party and have been approved
for publication, the same publications do not have to be provided again to the other Party for
review for a later submission for publication. Expedited reviews for abstracts or poster
presentations may be arranged if mutually agreeable to the Parties. Each Party will acknowledge
the other Party’s contributions in any such publication.

     10.3      Terms of this Agreement; Publicity.

           (a)      Restrictions.   The Parties agree that the terms of this Agreement will be treated as
Confidential Information of both Parties, and thus may be disclosed only as permitted by Section
10.1(d). Except as require by law, each Party agrees not to issue any press release or public
statement disclosing information relating to this Agreement or the transactions contemplated hereby
or the terms hereof without the prior written consent of the other Party not to be unreasonably
withheld (or as such consent may be obtained in accordance with Section 10.3(b)), or as permitted
by Section 10.3(c). Notwithstanding the foregoing, and in addition to those disclosures permitted
by Section 10.1(d), Avila will have the right to disclose publicly the following facts: (i) payment
of Milestone Payments to Avila by Clovis but not the amounts; and (ii) the successful progression
of the Lead Candidate and Licensed Products to the next stage of clinical development or regulatory
approval.

           (b)      Review.  In the event either Party (the “Issuing Party”) desires to issue a press release
or other public statement disclosing information relating to this Agreement or the transactions
contemplated hereby or the terms hereof, the Issuing Party will provide the other Party (the
“Reviewing Party”) with a copy of the proposed press release or public statement (the “Release”).
The Issuing Party will specify with each such Release, taking into account the urgency of the
matter being disclosed, a reasonable period of time within which the Receiving Party may provide
any comments on such Release and if the Receiving Party fails to provide any comments during the
response period called for by the Issuing Party, the Reviewing Party will be deemed to have
consented to the issuance of such Release; provided, however, that as it relates to the disclosure
of the results of any clinical trial conducted by Clovis or any

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Amended and Restated Strategic License Agreement

health or safety matter related to a Licensed Product, Avila acknowledges that announcements
may need to be made on extremely short notice, and although Clovis will endeavor to provide Avila
adequate time for such a review, Clovis will be free to make necessary public disclosures as
promptly as it deems necessary and appropriate. If the Receiving Party provides any comments, the
Parties will consult on such Release and work in good faith to prepare a mutually acceptable
Release. Either Party may subsequently publicly disclose any information previously contained in
any Release so consented to.

           (c)      Joint Press Release.   The Parties agree to issue the joint press release on Exhibit
10.3(c) promptly following the Effective Date.

     10.4      Relationship to the Confidentiality Agreement.  This Agreement supersedes that
certain “Mutual Confidentiality Agreement” between the Parties dated July 8, 2009 (the
“Confidentiality Agreement”); provided that all “Confidential Information” disclosed or received by
the Parties thereunder will be deemed “Confidential Information” hereunder and will be subject to
the terms and conditions of this Agreement.

11.      Warranties; Limitations of Liability; Indemnification.

     11.1      Representations and Warranties.   Each Party represents and warrants to the other
as of the Effective Date that it has the legal right and power to enter into this Agreement, to
extend the rights and licenses granted or to be granted to the other in this Agreement, and to
fully perform its obligations hereunder.

     11.2      Additional Representations and Warranties of Avila. Avila represents and
warrants to Clovis that, as of the Effective Date:

           (a)      Avila Controls the Patents listed on Exhibit 1.7 and the Avila Know-How, and is entitled
to grant the licenses specified herein. Avila has not caused any Patent included on such Exhibit
to be subject to any liens or encumbrances and Avila has not granted to any Third Party any rights
or licenses under such Patents or Avila Know-How that would conflict with the licenses granted to
Clovis hereunder. No Patents listed on Exhibit 1.7 are in-licensed by Avila.

           (b)      To Avila’s Knowledge, the Patents listed on Exhibit 1.7 have been procured or are being
procured from the respective patent offices in accordance with applicable law.

           (c)      Avila has no Knowledge of any claim or litigation that has been brought or threatened in
writing by any Third Party alleging that the Patents listed on Exhibit 1.7 are invalid or
unenforceable.

     11.3      Disclaimers.  Without limiting the respective rights and obligations of the
Parties expressly set forth herein, each Party specifically disclaims any guarantee that the
Collaboration Program or any Licensed Products or Companion Diagnostics will be successful, in
whole or in part. The failure of the Parties to successfully identify a Lead Candidate will not,
of itself, constitute a breach of any representation or warranty under this Agreement. EXCEPT AS
OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO
WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO ANY AVILA PATENTS, AVILA KNOW-HOW,
CLOVIS TECHNOLOGY, RESEARCH CANDIDATES, MATERIALS, THE LEAD CANDIDATE, LICENSED PRODUCTS, COMPANION
DIAGNOSTICS, OR RESEARCH PROGRAM KNOW-HOW, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY OF
ANY PATENT RIGHTS, TITLE, QUALITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE,
PERFORMANCE, AND NONINFRINGEMENT OF ANY THIRD PARTY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS.

     11.4      No Consequential Damages.   NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR
OTHERWISE, NEITHER PARTY WILL BE LIABLE TO THE OTHER OR ANY THIRD PARTY WITH RESPECT TO ANY SUBJECT
MATTER OF THIS AGREEMENT FOR ANY INDIRECT,

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Amended and Restated Strategic License Agreement

PUNITIVE, SPECIAL OR CONSEQUENTIAL DAMAGES, EVEN IF SUCH PARTY HAS BEEN INFORMED OR SHOULD
HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED THAT THIS SECTION 11.4 WILL NOT APPLY TO
THE PARTIES’ INDEMNIFICATION RIGHTS AND OBLIGATIONS UNDER SECTION 11.6.

     11.5      Performance by Others.   The Parties recognize that each Party may perform some or
all of its obligations under this Agreement through Affiliates and permitted subcontractors
provided, however, that each Party will remain responsible and liable for the performance by its
Affiliates and permitted subcontractors and will cause its Affiliates and permitted subcontractors
to comply with the provisions of this Agreement in connection therewith.

     11.6      Indemnification.

           (a)      Indemnification by Clovis. Clovis will indemnify Avila, its Affiliates and their
respective directors, officers, employees, Third Party licensors and agents, and their respective
successors, heirs and assigns (collectively, “Avila Indemnitees”), and defend and save each of them
harmless, from and against any and all losses, damages, liabilities, costs and expenses (including
reasonable attorneys’ fees and expenses) (collectively, “Losses”) in connection with any and all
suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”)
arising from or occurring as a result of: (i) the material breach by Clovis of any term of this
Agreement; (ii) any gross negligence or willful misconduct on the part of Clovis in performing its
obligations under this Agreement; (iii) any such Third Party Claims relating to any alleged
infringement or misappropriation of Patents or other intellectual property rights by Avila as part
of the Collaboration Program based on use of Clovis Technology or with respect to the Targets; or
(iv) the Development or Commercialization by Clovis or any of its Affiliates, Sublicensees or
Distributors of the Lead Candidate or Licensed Products or Companion Diagnostics, including any
such Third Party Claims relating to any alleged infringement or misappropriation of Patents or
other intellectual property rights, except in each case for those Losses as to which Avila has an
obligation to indemnify Clovis pursuant to Section 11.6(b), as to which Losses each Party will
indemnify the other to the extent of their respective liability; provided, however, that Clovis
will not be obligated to indemnify Avila Indemnitees for any Losses to the extent that such Losses
arise as a result of gross negligence or willful misconduct on the part of an Avila Indemnitee.

           (b)      Indemnification of Clovis. Avila will indemnify Clovis, its Affiliates and their
respective directors, officers, employees and agents, and their respective successors, heirs and
assigns (collectively, “Clovis Indemnitees”), and defend and save each of them harmless, from and
against any and all Losses in connection with any and all Third Party Claims arising from or
occurring as a result of: (i) the material breach by Avila of any term of this Agreement; or (ii)
any gross negligence or willful misconduct on the part of Avila in performing its obligations under
this Agreement, except in each case for those Losses for which Clovis has an obligation to
indemnify Avila pursuant to Section 11.6(a), as to which Losses each Party will indemnify the other
to the extent of their respective liability for the Losses; provided, however, that Avila will not
be obligated to indemnify Clovis Indemnitees for any Losses to the extent that such Losses arise as
a result of gross negligence or willful misconduct on the part of a Clovis Indemnitee.

          (c)      Notice of Claim. All indemnification claims provided for in Section 11.6(a) and 11.6(b)
will be made solely by such Party to this Agreement (the “Indemnified Party”). The Indemnified
Party will promptly notify the indemnifying Party (an “Indemnification Claim Notice”) of any Losses
or the discovery of any fact upon which the Indemnified Party intends to base a request for
indemnification under Section 11.6(a) or 11.6(b), but in no event will the indemnifying Party be
liable for any Losses that result from any delay in providing such notice. Each Indemnification
Claim Notice must contain a description of the claim and the nature and estimated amount of such
Loss (to the extent that the nature and amount of such Loss is known at such time). The
Indemnified Party will furnish promptly to the indemnifying Party copies of all papers and official
documents received in respect of any Losses and Third Party Claims.

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 Amended and Restated Strategic License Agreement

           (d)      Defense, Settlement, Cooperation and Expenses.

                (i)      Control of Defense. At its option, the indemnifying Party may assume the defense of any
Third Party Claim by giving written notice to the Indemnified Party within thirty (30) days after
the indemnifying Party’s receipt of an Indemnification Claim Notice. The assumption of the defense
of a Third Party Claim by the indemnifying Party will not be construed as an acknowledgment that
the indemnifying Party is liable to indemnify the Indemnified Party in respect of the Third Party
Claim, nor will it constitute a waiver by the indemnifying Party of any defenses it may assert
against the Indemnified Party’s claim for indemnification. Upon assuming the defense of a Third
Party Claim, the indemnifying Party may appoint as lead counsel in the defense of the Third Party
Claim any legal counsel selected by the indemnifying Party (the indemnifying Party will consult
with the Indemnified Party with respect to a possible conflict of interest of such counsel retained
by the indemnifying Party). In the event the indemnifying Party assumes the defense of a Third
Party Claim, the Indemnified Party will immediately deliver to the indemnifying Party all original
notices and documents (including court papers) received by the Indemnified Party in connection with
the Third Party Claim. Should the indemnifying Party assume the defense of a Third Party Claim,
except as provided in Section 11.6(d)(ii), the indemnifying Party will not be liable to the
Indemnified Party for any legal costs or expenses subsequently incurred by such Indemnified Party
in connection with the analysis, defense or settlement of the Third Party Claim. In the event that
it is ultimately determined that the indemnifying Party is not obligated to indemnify, defend or
hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party
will reimburse the indemnifying Party for any and all costs and expenses (including attorneys’ fees
and costs of suit) and any Third Party Claims incurred by the indemnifying Party in its defense of
the Third Party Claim.

                (ii)      Right to Participate in Defense. Without limiting Section 11.6(d)(i), any Indemnified
Party will be entitled to participate in, but not control, the defense of such Third Party Claim
and to employ counsel of its choice for such purpose; provided, however, that such employment will
be at the Indemnified Party’s own cost and expense unless (i) the employment thereof has been
specifically authorized by the indemnifying Party in writing, (ii) the indemnifying Party has
failed to assume the defense and employ counsel in accordance with Section 11.6(d)(i) (in which
case the Indemnified Party will control the defense) or (iii) the interests of the Indemnified
Party and the indemnifying Party with respect to such Third Party Claim are sufficiently adverse to
prohibit the representation by the same counsel of both Parties under applicable law, ethical rules
or equitable principles in which case the indemnifying Party will assume one hundred percent (100%)
of any such costs and expenses of counsel for the Indemnified Party.

                (iii)      Settlement. With respect to any Third Party Claims that relate solely to the payment of
money damages in connection with a Third Party Claim and that will not result in the Indemnified
Party’s becoming subject to injunctive or other relief or otherwise adversely affecting the
business of the Indemnified Party in any manner, and as to which the indemnifying Party will have
acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the
indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any
settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its sole
discretion, will deem appropriate. With respect to all other Losses in connection with Third Party
Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in accordance
with Section 11.6(d)(i), the indemnifying Party will have authority to consent to the entry of any
judgment, enter into any settlement or otherwise dispose of such Loss provided it obtains the prior
written consent of the Indemnified Party (which consent will not be unreasonably withheld). The
indemnifying Party will not be liable for any settlement or other disposition of a Loss by an
Indemnified Party that is reached without the written consent of the indemnifying Party.
Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim,
no

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Amended and Restated Strategic License Agreement

Indemnified Party will admit any liability with respect to or settle, compromise or discharge,
any Third Party Claim without the prior written consent of the indemnifying Party, such consent not to
be unreasonably withheld.

                (iv)      Cooperation.     Regardless of whether the indemnifying Party chooses to defend or prosecute
any Third Party Claim, the Indemnified Party will, and will cause each other Indemnified Party to,
cooperate in the defense or prosecution thereof and will furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings,
trials and appeals as may be reasonably requested in connection therewith. Such cooperation will
include access during normal business hours afforded to indemnifying Party to, and reasonable
retention by the Indemnified Party of, records and information that are reasonably relevant to such
Third Party Claim, and making Indemnified Parties and other employees and agents available on a
mutually convenient basis to provide additional information and explanation of any material
provided hereunder, and the indemnifying Party will reimburse the Indemnified Party for all its
reasonable out-of-pocket costs and expenses in connection therewith.

                (v)      Costs and Expenses.    Except as provided above in this Section 11.6(d), the costs and
expenses, including attorneys’ fees and expenses, incurred by the Indemnified Party in connection
with any claim will be reimbursed on a calendar quarter basis by the indemnifying Party, without
prejudice to the indemnifying Party’s right to contest the Indemnified Party’s right to
indemnification and subject to refund in the event the indemnifying Party is ultimately held not to
be obligated to indemnify the Indemnified Party.

     11.7      Insurance.    Each Party will maintain at its sole cost and expense, an adequate
liability insurance or self-insurance program (including product liability insurance) to protect
against potential liabilities and risk arising out of activities to be performed under this
Agreement and any agreement related hereto and upon such terms (including coverages, deductible
limits and self-insured retentions) as are customary in the U.S. pharmaceutical industry for the
activities to be conducted by such Party under this Agreement. Subject to the preceding sentence,
such liability insurance or self-insurance program will insure against all types of liability,
including personal injury, physical injury or property damage arising out of the manufacture, sale,
use, distribution or marketing of Licensed Products or Companion Diagnostics. The coverage limits
set forth herein will not create any limitation on a Party’s liability to the other under this
Agreement.

12.      Term and Termination.

     12.1      Term.     This Agreement will commence as of the Effective Date and, unless sooner
terminated in accordance with the terms hereof or by mutual written consent, will continue on an
Licensed Product-by-Licensed Product and country-by-country basis, until there are no more payments
owed Avila on such Licensed Products in such country (the longest such period of time for any
Licensed Products hereunder, the “Term”). Upon there being no more such payments hereunder for any
such Licensed Product in such country, the licenses contained in Section 5.1(b) for Avila Know-How,
as applicable, will become fully paid up and non-exclusive with respect to such Licensed Product in
such country.

     12.2      Termination by Avila.

           (a)      Breach.    Avila will have the right to terminate this Agreement in full upon delivery of
written notice to Clovis in the event of any material breach by Clovis of any terms and conditions
of this Agreement, provided that such termination will not be effective if such breach has been
cured within ninety (90) days after written notice thereof is given by Avila to Clovis specifying
the nature of the alleged breach (or, if such default cannot be cured within such ninety (90) day
period, within one hundred and eighty (180) days after such notice if Clovis commences actions to
cure such default within such 90-day period and thereafter diligently continues such actions, but
fails to cure the default by the end of such 180-days); provided, however, that to the extent such
material breach involves the failure to make a

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Amended and Restated Strategic License Agreement

payment when due, such breach must be cured within thirty (30) days after written notice
thereof is given by Avila to Clovis.

           (b)      Termination for IP Challenge.     Avila will have the right to terminate this Agreement in
full upon written notice to Clovis in the event that Clovis or any of its Affiliates, Sublicensees
or Distributors directly or indirectly challenges in a legal or administrative proceeding the
patentability, enforceability or validity of any Avila Patents; provided that Avila will not have
the right to terminate this Agreement under this Section 12.2(b) for any such challenge by any
Sublicensee or Distributor if such challenge is dismissed within thirty (30) days of Avila’s notice
to Clovis under this Section 12.2(b) and not thereafter continued.

     12.3      Termination by Clovis.

          (a)      Breach.    Clovis will have the right to terminate this Agreement in full upon delivery of
written notice to Avila in the event of any material breach by Avila of any terms and conditions of
this Agreement, provided that such termination will not be effective if such breach has been cured
within ninety (90) days after written notice thereof is given by Clovis to Avila specifying the
nature of the alleged breach (or, if such default cannot be cured within such ninety (90) day
period, within one hundred and eighty (180) days after such notice if Avila commences actions to
cure such default within such 90-day period and thereafter diligently continues such actions, but
fails to cure the default by the end of such 180-days).

          (b)      Discretionary Termination.    Beginning with the *** month anniversary of the Effective Date,
Clovis will have the right to terminate this Agreement in full ninety (90) days after delivery of
written notice to Avila if the Board of Directors of Clovis concludes due to scientific, technical,
regulatory or commercial reasons, including (i) safety or efficacy concerns, including adverse
events of the Licensed Product, (ii) concerns relating to the present or future marketability or
profitability of the Licensed Product, (iii) reasons related to Patent coverage or (iv) existing
and anticipated competition, renders the Development of the Lead Candidate or the Commercialization
of the Licensed Product no longer commercially practicable for Clovis.

     12.4      Termination Upon Bankruptcy.

           (a)      Termination Right.     Either Party may terminate this Agreement if, at any time, the other
Party will file in any court or agency pursuant to any statute or regulation of any state, country
or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement
or for the appointment of a receiver or trustee of that Party or of its assets, or if the other
Party proposes a written agreement of composition or extension of its debts, or if the other Party
will be served with an involuntary petition against it, filed in any insolvency proceeding, and
such petition will not be dismissed within sixty (60) days after the filing thereof, or if the
other Party will propose or be a Party to any dissolution or liquidation, or if the other Party
will make an assignment for the benefit of its creditors.

           (b)      Consequences of Bankruptcy.    All rights and licenses granted under or pursuant to this
Agreement by Clovis or Avila or their Affiliates are, and will otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual
property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the
Parties and their respective Affiliates, Sublicensees and Third Party sublicensees, as licensees of
such rights under this Agreement, will retain and may fully exercise all of their rights and
elections under the U.S. Bankruptcy Code and any foreign counterparts thereto.

     12.5      Effects of Termination.     Upon termination by either Party under Sections 12.2,
12.3 or 12.4:

           (a)      Clovis will responsibly wind-down, in accordance with accepted pharmaceutical industry
norms and ethical practices, any on-going clinical studies for which it has responsibility
hereunder in which patient dosing has commenced or, if reasonably practicable and requested by
Avila, allow Clovis,

32

 

Amended and Restated Strategic License Agreement

its Affiliates or its Sublicensees to complete such trials. Clovis will be responsible for
any costs associated with such wind-down. Avila will pay all costs incurred by either Party to
complete such studies should Avila request that such studies be completed.

           (b)      A termination of this Agreement, will not automatically terminate any sublicense granted
by Clovis pursuant to Section 5.3 with respect to a non-Affiliated Sublicensee, provided that (i)
such Sublicensee is not then in breach of any provision of this Agreement or the applicable
sublicense agreement, (ii) Avila will have the right to step into the role of Clovis as
sublicensor, with all the rights that Clovis had under such sublicense prior to termination of this
Agreement (including the right to receive any payments to Clovis by such Sublicensee that accrue
from and after the date of the termination of this Agreement) and (iii) Avila will only have those
obligations to such Sublicensee as Avila had to Clovis hereunder and that Avila is able to satisfy
with respect to such Sublicensee based on the provisions of Sections 12.5(d) through 12.5(f) (and
no other obligations). Clovis will include in any sublicense agreement a provision in which said
Sublicensee acknowledges its obligations to Avila hereunder and the rights of Avila to terminate
this Agreement with respect to any Sublicensee for material breaches of this Agreement by such
Sublicensee that are within the scope of Section 12.2. The failure of Clovis to include in a
sublicense agreement the provision referenced in the immediately preceding sentence will render the
affected sublicense void ab initio.

           (c)      Except as otherwise expressly provided in Section 12.5(b), all rights and licenses granted
by Avila to Clovis in Section 5 will terminate, and Clovis and its Affiliates, Sublicensees and
Distributors will cease all use of Avila Know-How and Avila Patents and all Development and
Commercialization of any Licensed Products or Companion Diagnostics.

           (d)      All Regulatory Approvals and other regulatory filings and communications owned (in whole
or in part) or otherwise controlled by Clovis and its Affiliates, Sublicensees and Distributors,
and all other documents relating to or necessary to further Develop and Commercialize the Lead
Candidate and Licensed Products and Companion Diagnostics, as such items exist as of the effective
date of such termination (including all related completed and ongoing clinical studies) will be
assigned to Avila, and Clovis will provide to Avila one (1) copy of the foregoing and all documents
contained in or referenced in any such items, together with the raw and summarized data for any
clinical studies (and where reasonably available, electronic copies thereof). In the event of
failure to obtain assignment, Clovis hereby consents and grants to Avila the right to access and
reference (without any further action required on the part of Clovis, whose authorization to file
this consent with any Regulatory Authority is hereby granted) any such item.

           (e)      Clovis hereby grants to Avila and its Affiliates, and Avila and its Affiliates will
automatically have, a worldwide, perpetual and irrevocable, royalty-free and fully paid-up,
nontransferable (except in connection with a permitted assignment of this Agreement in accordance
with Section 13.12), exclusive license, with the right to grant sublicenses through multiple tiers,
under Know-How and Patents that both (i) arise from the Collaboration Program or the Clovis
Development & Commercialization Program (including Collaboration Program Know-How and all Patents
arising therefrom) and (ii) are Controlled by Clovis or any of its Affiliates and Sublicensees
(other than those non-Affiliated Sublicensees that continue with a direct license from Avila
pursuant to Section 12.5(b)), such license effective only as of and after the effective date of
such termination, for discovering, Developing and Commercializing covalent inhibitors of the
Targets, including the Lead Candidate and Licensed Products and Companion Diagnostics. The Patents
so licensed will be subject to the Prosecution and Maintenance and enforcement and defense rights
and obligations set forth in Sections 8 and 9 as “Subject Patents” thereunder, with the roles of
Avila and Clovis reversed (and such other changes as are appropriate from the context).

           (f)      Clovis will assign (or, if applicable, will cause its Affiliates or Sublicensees to
assign) to Avila all of Clovis’s (and such Affiliates’ and Sublicensees’) right, title and interest
in and to any

33

 

Amended and Restated Strategic License Agreement

registered or unregistered trademarks or internet domain names that are specific to the Lead
Candidate and Licensed Products worldwide (it being understood that the foregoing will not include
any trademarks or internet domain names that contain the corporate or business name(s) of Clovis).

     12.6      Survival.    In addition to the termination consequences set forth in Section 12.5,
the following provisions will survive termination or expiration of this Agreement, as well as any
other provision which by its terms or by the context thereof, is intended to survive such
termination: Section 1, 2.2(a), 2.2(c)(ii), 5.2(b), 5.7, 6.7, 6.8, 7, 9.2 (for any infringement
occurring prior to termination or expiration of this Agreement), 10, 11.3, 11.4, 11.5, 11.6, 12 and
13. Termination or expiration of this Agreement will not relieve the Parties of any liability or
obligation which accrued hereunder prior to the effective date of such termination or expiration
nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or
in equity with respect to any breach of this Agreement nor prejudice either Party’s right to
obtain performance of any obligation. All other rights and obligations will terminate upon
expiration of this Agreement.

13.      General Provisions.

     13.1      Dispute Resolution.

           (a)      Disputes.     Disputes arising under or in connection with this Agreement will be resolved
pursuant to this Section 13.1; provided, however, that in the event a dispute cannot be resolved
without an adjudication of the rights or obligations of a Third Party (other than any Avila
Indemnitees or Clovis Indemnitees identified in Section 11.6), the dispute procedures set forth
Sections 13.1(c) and 13.1(d) will be inapplicable as to such dispute.

           (b)      Dispute Escalation.    In the event of a dispute between the Parties, the Parties will first
attempt in good faith to resolve such dispute by negotiation and consultation between themselves or
the Program Directors. In the event that such dispute is not resolved on an informal basis within
twenty (20) days, any Party may, by written notice to the other, have such dispute referred to the
Avila CEO and the Clovis CEO or in either case his or her designee (who will be a senior
executive), who will attempt in good faith to resolve such dispute by negotiation and consultation
for a thirty (30) day period following receipt of such written notice.

           (c)      Full Arbitration.     Unless Section 13.1(d) is applicable, in the event the Parties are not
able to resolve such dispute through mediation, either Party may at any time after such 20-day
period submit such dispute to be finally settled by arbitration administered in accordance with the
rules of Judicial Administration and Arbitration Services (“JAMS”) in effect at the time of
submission, as modified by this Section 13.1. The arbitration will be heard and determined by
three (3) arbitrators who are retired judges or attorneys with at least ten (10) years of
experience in the pharmaceutical and biotechnology industry, each of whom will be a neutral. Each
Party will appoint one arbitrator and the third arbitrator will be selected by the two
Party-appointed arbitrators, or, failing agreement within thirty (30) days following the date of
receipt by the respondent of the claim, by JAMS. Such arbitration will take place in New York, NY.
The arbitration award so given will be a final and binding determination of the dispute, will be
fully enforceable in any court of competent jurisdiction, and will not include any damages
expressly prohibited by Section 11.4. Fees, costs and expenses of arbitration are to be divided by
the Parties in the following manner: Clovis will pay for the arbitrator it chooses, Avila will pay
for the arbitrator it chooses, and the Parties will share payment for the third arbitrator. Except
in a proceeding to enforce the results of the arbitration or as otherwise required by law, neither
Party nor any arbitrator may disclose the existence, content or results of any arbitration
hereunder without the prior written agreement of both Parties.

34

 

Amended and Restated Strategic License Agreement

           (d)      Accelerated Arbitration.     To the extent the arbitration matter involves a dispute that is
submitted to arbitration by a Party under either Sections 6.2, 6.4(e), or 6.7(c), or any dispute
regarding the proper characterization of a dispute subject to resolution under this Section 13.1(d)
as opposed to Section 13.1(c), the following procedures will also apply:

               (i)      For purposes of arbitration under this Section 13.1(d), the arbitrator will be
appointed pursuant to Section 13.1(c), but will be a single independent, conflict-free
arbitrator with the requisite licensing and pharmaceutical industry experience (such
arbitrator, the “Expert”). The Parties may select a different Expert for each dispute
depending on the nature of the issues presented and desired expertise.

               (ii)      Each Party will prepare and submit a written summary of such Party’s position and
any relevant evidence in support thereof to the Expert within thirty (30) days of the
selection of the Expert. Upon receipt of such summaries from both Parties, the Expert will
provide copies of the same to the other Party. The Expert will be authorized to solicit
briefing or other submissions on particular questions. Within fifteen (15) days of the
delivery of such summaries by the Expert, each Party will submit a written rebuttal of the
other Party’s summary and may also amend and re-submit its original summary. Oral
presentations will not be permitted unless otherwise requested by the Expert. The Expert
will make a final decision with respect to the arbitration matter within thirty (30) days
following receipt of the last of such rebuttal statements submitted by the Parties and will
make a determination by selecting the resolution proposed by one of the Parties that as a
whole is the most fair and reasonable to the Parties in light of the totality of the
circumstances and will provide the Parties with a written statement setting forth the basis
of the determination in connection therewith. For purposes of clarity, the Expert will only
have the right to select a resolution proposed by one of the Parties in its entirety and
without modification.

               (iii)      The Parties further agree that the decision of the Expert will be the sole,
exclusive and binding remedy between them regarding determination of the arbitration matter
so presented. Confirmation of, or judgment upon any award rendered pursuant to this Section
13.1(d) may be entered by any court of competent jurisdiction. The Expert will have no
authority to award any type of damages excluded under Section 11.4.

            (e)      Injunctive Relief.    Notwithstanding the dispute resolution procedures set forth in this
Section 13.1, in the event of an actual or threatened breach hereunder, the aggrieved Party may
seek equitable relief (including restraining orders, specific performance or other injunctive
relief) in any court or other forum, without first submitting to any dispute resolution procedures
hereunder.

           
(f)      Tolling.     The Parties agree that all applicable statutes of limitation and time-based
defenses (such as estoppel and laches) will be tolled while the dispute resolution procedures set
forth in this Section 13.1 are pending, and the Parties will cooperate in taking all actions
reasonably necessary to achieve such a result. In addition, during the pendency of any arbitration
under this Agreement initiated before the end of any applicable cure period under Section 12.2 or
12.3, (i) this Agreement will remain in full force and effect, (ii) the provisions of this
Agreement relating to termination for material breach will not be effective, (iii) the time periods
for cure under Section 12 as to any termination notice given prior to the initiation of arbitration
will be tolled, and (iv) neither Party will issue a notice of termination pursuant to such
sections, until the arbitral tribunal has confirmed the existence of the facts claimed by a Party
to be the basis for the asserted material breach.

     13.2      Cumulative Remedies and Irreparable Harm. All rights and remedies of the Parties
hereunder will be cumulative and in addition to all other rights and remedies provided hereunder or
available by agreement, at law or otherwise. Each Party acknowledges and agrees that breach of any
of the terms or conditions of this Agreement would cause irreparable harm and damage to the other
and that such damage may not be ascertainable in money damages and that as a result thereof the non
breaching Party would be

35

 

Amended and Restated Strategic License Agreement

entitled to seek from a court equitable or injunctive relief restraining any breach or future
violation of the terms contained herein by the breaching Party without the necessity of proving
actual damages or posting bond. Such right to equitable relief is in addition to whatever remedies
either Party may be entitled to as a matter of law or equity, including money damages.

     13.3      Industry Transaction.     Notwithstanding anything to the contrary herein, no
Know-How, Materials (including covalent inhibitors), Patents or other intellectual property rights
not Controlled by Avila or any of its Affiliates prior to an Industry Transaction for Avila will be
Controlled for purposes of this Agreement after such Industry Transaction, other than (i)
Collaboration Program Know-How no matter when Controlled, and (ii) any Patent that claims priority,
directly or indirectly, to any other Patent first Controlled before the Industry Transaction will
be Controlled thereafter no matter when such Patent is filed or issued. For the purposes of this
Agreement, (a) “Industry Transaction” for a Party will mean that (x) such Party will have become an
Affiliate of an entity that is a Drug Company (as defined below), or (y) any sale, license or other
transfer (in one transaction or a series of related transactions, and by any means, including by
merger or consolidation) of all or substantially all of such Party’s assets or that portion of its
business pertaining to the subject matter of this Agreement will have occurred to a Drug Company,
and (b) “Drug Company” will mean any entity that conducts R&D in the biotechnology or
pharmaceutical industry or develops or commercializes therapeutics or diagnostics.

     13.4      Relationship of Parties.     Nothing in this Agreement is intended or will be deemed
to constitute a partnership, agency, employer-employee or joint venture relationship between the
Parties. No Party will incur any debts or make any commitments for the other, except to the
extent, if at all, specifically provided therein. There are no express or implied third party
beneficiaries hereunder (except for Avila Indemnitees and Clovis Indemnitees for purposes of
Section 11.6).

     13.5      Compliance with Law.     Each Party will perform or cause to be performed any and
all of its obligations or the exercise of any and all of its rights hereunder in good scientific
manner and in compliance with all applicable law.

     13.6      Governing Law.     This Agreement will be governed by and construed in accordance
with the laws of the State of New York, without respect to its conflict of laws rules, provided
that any dispute relating to the scope, validity, enforceability or infringement of any Patents or
Know-How will be governed by, and construed and enforced in accordance with, the substantive laws
of the jurisdiction in which such Patents or Know-How apply.

     13.7      Counterparts; Facsimiles.     This Agreement may be executed in one or more
counterparts, each of which will be deemed an original, and all of which together will be deemed to
be one and the same instrument. Facsimile or PDF execution and delivery of this Agreement by
either Party will constitute a legal, valid and binding execution and delivery of this Agreement by
such Party

     13.8      Headings.     All headings in this Agreement are for convenience only and will not
affect the meaning of any provision hereof.

     13.9      Waiver of Rule of Construction.     Each Party has had the opportunity to consult
with counsel in connection with the review, drafting and negotiation of this Agreement.
Accordingly, the rule of construction that any ambiguity in this Agreement will be construed
against the drafting party will not apply.

     13.10      Interpretation.    Whenever any provision of this Agreement uses the term
“including” (or “includes”), such term will be deemed to mean “including without limitation” (or
“includes without limitations”). “Herein,” “hereby,” “hereunder,” “hereof” and other equivalent
words refer to this Agreement as an entirety and not solely to the particular portion of this
Agreement in which any such word is used. All definitions set forth herein will be deemed
applicable whether the words defined are used herein in the singular or the plural. Unless
otherwise provided, all references to Sections and Exhibits in this Agreement are to Sections and
Exhibits of this Agreement. References to any Sections

36

 

Amended and Restated Strategic License Agreement

include Sections and subsections that are part of the related Section (e.g., a section
numbered “Section 2.1” would be part of “Section 2”, and references to “Section 2.1” would also
refer to material contained in the subsection described as “Section 2.1(a)”).

     13.11      Binding Effect.   This Agreement will inure to the benefit of and be binding upon
the Parties, their Affiliates, and their respective lawful successors and assigns.

     13.12      Assignment.   This Agreement may not be assigned by either Party, nor may either
Party delegate its obligations or otherwise transfer licenses or other rights created by this
Agreement, except as expressly permitted hereunder or otherwise without the prior written consent
of the other Party, which consent will not be unreasonably withheld; provided that (i) Clovis may
assign this Agreement to an Affiliate or to its successor in connection with the merger,
consolidation, or sale of all or substantially all of its assets, and (ii) Avila may assign this
Agreement to an Affiliate or to its successor in connection with the merger, consolidation, or sale
of all or substantially all of its assets or that portion of its business pertaining to the subject
matter of this Agreement.

     13.13      Notices.   All notices, requests, demands and other communications required or
permitted to be given pursuant to this Agreement will be in writing and will be deemed to have been
duly given upon the date of receipt if delivered by hand, recognized international overnight
courier, confirmed facsimile transmission, or registered or certified mail, return receipt
requested, postage prepaid to the following addresses or facsimile numbers:

	 	 	 

	If to Avila:

	 	Avila Therapeutics, Inc.
	 

	 	100 Beaver Street
	 

	 	Waltham, MA 02453
	 

	 	Attention: Chief Executive Officer
	 

	 	Facsimile: 781-891-0069
	 
	 	 
	With a copy to:

	 	Goodwin | Procter LLP
	 

	 	53 State Street
	 

	 	Boston, MA 02109
	 

	 	Attention: Kingsley L. Taft, Esq.
	 

	 	Facsimile: 617-523-1231
	 
	 	 
	If to Clovis:

	 	Clovis Oncology, Inc.
	 

	 	2525 28th Street
	 

	 	Boulder, CO 80301
	 

	 	Attention: Chief Executive Officer
	 

	 	Facsimile: 303-245-0361
	 
	 	 
	With a copy to:

	 	Willkie Farr & Gallagher LLP
	 

	 	787 Seventh Avenue
	 

	 	New York, NY 10019
	 

	 	Attention: Peter H. Jakes
	 

	 	Facsimile: (212) 728-8111

Either Party may change its designated address and facsimile number by notice to the other Party in
the manner provided in this Section 13.13.

     13.14      Amendment and Waiver.   This Agreement may be amended, supplemented, or otherwise
modified only by means of a written instrument signed by both Parties; provided that any unilateral
undertaking or waiver made by one Party in favor of the other will be enforceable if undertaken in
a writing signed by the Party to be charged with the undertaking or waiver. Any waiver of any
rights or failure to act in a specific instance will relate only to such instance and will not be
construed as an agreement to waive any rights or fail to act in any other instance, whether or not
similar.

37

 

 Amended and Restated Strategic License Agreement

     13.15      Severability.    In the event that any provision of this Agreement will, for any
reason, be held to be invalid or unenforceable in any respect, such invalidity or unenforceability
will not affect any other provision hereof, and the Parties will negotiate in good faith to modify
this Agreement to preserve (to the extent possible) their original intent.

     13.16      Entire Agreement.     This Agreement is the sole agreement with respect to the
subject matter and supersedes all other agreements and understandings between the Parties with
respect to same (including the Original Agreement and the Confidentiality Agreement).

     13.17      Force Majeure.    Neither Clovis nor Avila will be liable for failure of or delay
in performing obligations set forth in this Agreement (other than any obligation to pay monies when
due), and neither will be deemed in breach of such obligations, if such failure or delay is due to
natural disasters or any causes reasonably beyond the control of Clovis or Avila; provided that the
Party affected will promptly notify the other of the force majeure condition and will exert
reasonable efforts to eliminate, cure or overcome any such causes and to resume performance of its
obligations as soon as possible.

[Remainder of this Page Intentionally Left Blank]

38

 

Amended and Restated Strategic License Agreement

        IN WITNESS WHEREOF, the Parties have caused this Strategic License Agreement to be executed by
their respective duly authorized officers as of the A&R Date.

Avila Therapeutics, Inc.

	 	 	 	 	 

	By:

	 	/s/ KATRINE BOSLEY
	 	 
	 

	 	(Signature)	 	 
	 
	 	 	 	 
	Name:  

	 	Katrine Bosley	 	 
	 
	 	 	 	 
	Title:

	 	President and CEO	 	 
	 
	 	 	 	 
	Date:

	 	June 16, 2011	 	 
	 
	 	 	 	 
	Clovis Oncology, Inc.	 	 
	 
	 	 	 	 
	By:

	 	/s/ PATRICK J. MAHAFFY	 	 
	 

	 	(Signature)	 	 
	 
	 	 	 	 
	Name:

	 	Patrick J. Mahaffy	 	 
	 
	 	 	 	 
	Title:

	 	President and CEO	 	 
	 
	 	 	 	 
	Date:

	 	June 16, 2011	 	 

 

Amended and Restated Strategic License Agreement

Exhibit 1.7

Avila Patents as of the Effective Date

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
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	 	Title	 	 	Appln	 	 	Country	 	 	Inventors	 	 	Status as of the	 
	 	 	 	 	Type	 	 	 	 	 	 	 	 	 	 	 	Effective Date	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
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	 	 	***	 	 	***	 	 	 	 	 	***	 	 	***	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

a

 

Amended and Restated Strategic License Agreement

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	***	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Title	 	 	Appln	 	 	Country	 	 	Inventors	 	 	Status as of the	 
	 	 	 	 	Type	 	 	 	 	 	 	 	 	 	 	 	Effective Date	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	***
	 	 	***	 	 	***	 	 	 	 	 	***	 	 	***	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
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	 	 	***	 	 	***	 	 	 	 	 	***	 	 	***	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

b

 

Amended and Restated Strategic License Agreement

Exhibit 1.53

Targets

“Targets” comprise, collectively, ***

“Reference Sequence” is ***.

a

 

     

Amended and Restated Strategic License Agreement

Exhibit 2.1(b)

Collaboration Plan

***

a

 

     

Amended and Restated Strategic License Agreement

 

	 	 	 	 	 	 	 	 	 
	Collaboration Plan Budget (000’s)	 
	 
	 	 	 	 	 	 	 	 
	 	 	    2010	 	 	    2011	 
	 
	 	 	 	 	 	 	 	 
	Reimbursement for Avila FTEs
	 	$	*	**	 	$	*	**
	 
	 	 	 	 	 	 	 	 
	Clovis Internal Expenses
	 	 	*	**	 	 	*	**
	 
	 	 	 	 	 	 	 	 
	External Costs
	 	 	 	 	 	 	 	 
	Discovery
	 	 	*	**	 	 	*	**
	Non-clinical
	 	 	*	**	 	 	*	**
	CMC
	 	 	*	**	 	 	*	**
	Diagnostics
	 	 	*	**	 	 	*	**
	Clinical, Regulatory and Other
	 	 	*	**	 	 	*	**
	 
	 	 	 	 	 	 	 	 
	Total
	 	 	*	**	 	 	*	**

b

 

Amended and Restated Strategic License Agreement

Exhibit 2.1(c)

Initial Agreed Compound Profile

	 	 	 
	Attribute	Criteria (method)	Desired Limit

***

a

 

Amended and Restated Strategic License Agreement

Exhibit 8.1(a)

Proposed Prosecution and Maintenance Activities for Subject Patents

***

a

 

 
Amended and Restated Strategic License Agreement

Exhibit 10.3(c)

Joint Press Release

Clovis Oncology and Avila Therapeutics Sign $209 Million Partnership for the Worldwide
Development and Commercialization of EGFR Mutant-Selective Inhibitor

	 	•	 	Avila’s oral, small molecule program targets cancer-causing mutant forms of the EGF
receptor (EGFR)

	 
	 	•	 	Innovative treatment approach for non-small cell lung cancer (NSCLC) patients with
disease resistant to current therapy

	 
	 	•	 	Potency against key disease mutation, T790M, while minimizing activity against the
wild-type (normal) EGFR to increase therapeutic index and avoid side effects of current
standard of care

	 
	 	•	 	Clovis to lead accelerated clinical development plan including companion diagnostic to
prospectively identify T790M-positive NSCLC patients

Boulder, CO, and Waltham, MA, USA. May 25, 2010.

Clovis Oncology, Inc., a biopharmaceutical company focused on acquiring, developing and
commercializing innovative anti-cancer agents, and Avila Therapeutics, Inc., a biotechnology
company designing targeted covalent drugs, announced today an agreement for the development and
commercialization of Avila’s epidermal growth factor receptor (EGFR) mutant-selective inhibitor
(EMSI) program, currently in pre-clinical development for the treatment of non-small cell lung
cancer (NSCLC). The EMSI program targets the T790M mutant form of the EGFR associated with
clinical resistance to Tarceva® (erlotinib) and Iressa® (gefitinib)1, as well as
targeting the initial activating EGFR mutations, including L858R and exon 19 deletions. It does
so while also sparing the wild-type (normal) EGFR and may thus treat refractory NSCLC while
minimizing dose-limiting side effects. Because the program targets both the sensitive activating
mutations as well as the primary resistance mechanism, T790M, it has the potential to treat both
first- and second-line NSCLC patients with EGFR mutations, for whom there is great unmet medical
need.

“The T790M mutation seems to be the predominant mechanism underlying the development of resistance
of EGFR-mutant lung cancers to specific EGFR kinase inhibitors, and it may well explain why the
dramatic responses seen in these cases are of relatively short duration. The development of a drug
that is both mutant-specific and capable of irreversibly binding the enzyme is one of the most
exciting new developments in this field,” said Dr. Daniel Haber, director of the Massachusetts
General Hospital Cancer Center, who led a team that initially discovered EGFR mutations in lung
cancer. “Such an inhibitor could overcome this resistance mutation at dosage levels that would
spare the wild type EGFR in normal tissues. This could prove to be of major clinical significance,”
he added.

Under the terms of the agreement, Avila and Clovis Oncology will collaborate on the pre-clinical
development of the EMSI product candidate. Clovis Oncology will be fully responsible for all
aspects of development and commercialization, including development of companion diagnostics to
prospectively identify patients with clinically-arising resistance mutations of the EGFR. In
addition to research support, Avila will receive an upfront fee and be eligible to receive development, regulatory and
sales-

 

	 	 	 
	1	Tarceva and Iressa are registered trademarks
of F. Hoffman-La Roche and AstraZeneca, respectively.

a

 

Amended and Restated Strategic License Agreement

based milestone payments, with a total potential value of $209 million. Avila will also
receive tiered royalties on product sales and will share in selected sublicense income.

“Avila’s EMSI program has demonstrated very encouraging data against both the T790M resistance
mutation and the initiating activating mutations and we are very pleased to initiate this
partnership with them,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We plan to
file an IND as rapidly as possible and initiate an accelerated clinical development program,
including the use of a companion diagnostic to identify patients with NSCLC who possess the T790M
mutation. We believe that this program has the potential to meaningfully improve outcomes in
patients with EGFR-mediated non-small cell lung cancer.”

“Clovis Oncology is an ideal partner with whom to advance this exciting program given their deep
experience developing oncology drugs and their commitment to develop a companion diagnostic to
identify the right patients for the drug,” said Katrine Bosley, President and CEO of Avila
Therapeutics. “Resistance mutations in cancer-causing proteins are uniquely amenable to the
targeted covalent inhibition enabled by Avila’s platform and working together with Clovis will
accelerate advancement of this program.”

About Lung Cancer

Lung cancer is the most common cancer worldwide with 1.35 million new cases annually, and NSCLC
accounting for almost 85 percent of all lung cancers. NSCLC progresses rapidly with a five year
survival rate in advanced NSCLC patients of less than 5%. Activating EGFR mutations are key
drivers of NSCLC malignancy in 10-15% of patients of European descent and approximately 30% of
patients of East Asian descent.

Currently, agents for the treatment of NSCLC patients include Tarceva® and Iressa®, both
non-selective EGFR inhibitors. Both agents have significant skin-rash and diarrhea as side effects
related to inhibition of the wild-type (normal) EGFR in skin and intestine respectively. Acquired
resistance to Tarceva and Iressa occurs after a median of 12 months, driven in approximately 50% of
cases by a “gatekeeper mutation” called T790M. Patients with tumors containing this secondary
resistance EGFR mutation are clinically resistant to both first generation EGFR inhibitors (Tarceva
and Iressa) as well as second generation pan-ErbB inhibitors currently in clinical development.
By inhibiting both T790M and the initial activating mutations, the EMSI program offers the prospect
of effective drug treatment for first and second-line NSCLC patients with activating EGFR
mutations. With sparing of the wild-type EGFR, the EMSI program could also offer a much improved
therapeutic window compared to current therapies in a first-line setting.

About Clovis Oncology, Inc.

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and
commercializing innovative anti-cancer agents in the U.S., Europe and additional international
markets. Clovis intends to target development programs at specific subsets of cancer populations,
and will simultaneously develop diagnostic tools that direct a compound in development to the
population that is most likely to benefit from its use. The Company is currently developing CO-101
which is in Phase 2 development for the treatment of pancreatic cancer. The Company is
collaborating with Ventana Medical Systems to develop a companion diagnostic to identify patients
with low tumor expression of hENT1 and therefore likely to benefit from CO-101. The Company is
headquartered in Boulder, Colorado, and has additional offices in San Francisco and Cambridge,
England. For more information about Clovis Oncology, please visit the Company’s website at
www.clovisoncology.com.

About Avila Therapeutics

b

 

Amended and Restated Strategic License Agreement

Avila focuses on design and development of targeted covalent drugs to achieve best-in-class
outcomes that cannot be achieved through traditional chemistries. This approach is called “protein
silencing”. The company’s product pipeline has been built using its proprietary AvilomicsTM platform
and is currently focused on viral infection, cancer, and autoimmune disease. Avila is funded by
leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option
Fund, and Polaris Venture Partners. For additional information, please visit
http://www.avilatx.com.

For Further Information Contact:

For Clovis Oncology:

Scout Investor Relations

Breanna Burkart / Anna Sussman

303.907.5162 / 303.907.5358

Breanna@scoutir.com / anna@scoutir.com

For Avila Therapeutics:

Kathryn Morris

The Yates Network

845-635-9828

kathryn@theyatesnetwork.com

cexv10w3

Exhibit 10.3

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (“Agreement”) is made effective as of the 2nd day of June, 2011 (the
“Effective Date”), by and between Clovis Oncology, Inc., a corporation organized and existing under
the laws of Delaware with offices at 2525 28th Street, Boulder, CO 80301 (“LICENSEE”)
and PFIZER Inc., a corporation organized and existing under the laws of Delaware with offices at
235 East 42nd Street, New York, NY 10017 (“PFIZER”). LICENSEE and PFIZER may, from
time-to-time, be individually referred to as a “Party” and collectively referred to as the
“Parties”.

RECITALS

WHEREAS, PFIZER Controls the Licensed Technology (hereinafter defined); and

WHEREAS, LICENSEE wishes to obtain, and PFIZER wishes to grant, certain licenses under the
Licensed Technology on the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual agreements and covenants set forth herein and
other good and valuable consideration, the receipt and sufficiency of which the Parties hereby
acknowledge, the Parties, intending to be legally bound hereby, agree to the foregoing and as
follows:

	1.	 	DEFINITIONS

	 	1.1.	 	“Affiliate” means, with respect to a Party, any Person that controls, is
controlled by, or is under common control with that Party. For the purpose of this
definition, “control” shall refer to: (a) the possession, directly or indirectly, of
the power to direct the management or policies of an entity, whether through the
ownership of voting securities, by contract or otherwise, or (b) the ownership,
directly or indirectly, of fifty percent (50%) or more of the voting securities of such
entity.

	 
	 	1.2.	 	“Applicable Laws” means all applicable laws, statutes, rules, regulations and
guidelines, including, without limitation, all good manufacturing practices and all
applicable standards or guidelines promulgated by the appropriate Regulatory Authority.

	 
	 	1.3.	 	“Business Day” means any day other than a Saturday, a Sunday or a day on which
commercial banks located in New York, New York are authorized or required by law to
remain closed.

	 
	 	1.4.	 	“Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31.

	 
	 	1.5.	 	“Calendar Year” means any twelve (12) month period commencing on January 1.

 

 

	 	1.6.	 	“Collaboration Agreement” means the Collaboration Agreement between PFIZER, MDx
Health, SA, University of Newcastle upon Tyne and Cancer Research Technology Limited
(formerly Cancer Research Campaign Technology Limited) entered into as of
14th December 2010.

	 
	 	1.7.	 	“Collaboration and License Agreement” means the Collaboration and License
Agreement entered into as of 23rd September 1997 between Cancer Research
Campaign Technology Limited, University of Newcastle upon Tyne and Agouron
Pharmaceuticals, Inc (now an Affiliate of PFIZER), as amended by a First Amendment to
Collaboration and License Agreement dated 23 January 2000, as amended by a Second
Amendment to Collaboration and License Agreement dated 23 January 2001, and as amended
by an Amendment dated 1 January 2006 between Cancer Research Technology Limited
(formerly Cancer Research Campaign Technology Limited) and PFIZER.

	 
	 	1.8.	 	“Commercialize” or “Commercialization” means to manufacture for sale, market,
promote, otherwise offer for sale, distribute, and sell.

	 
	 	1.9.	 	“Commercially Reasonable Efforts” means, with respect to the Development or
Commercialization of a Product, that level of efforts and resources commonly dedicated
in the research-based pharmaceutical industry by a company to the development or
commercialization, as the case may be, of a product of similar commercial potential at
a similar stage in its lifecycle, in each case taking into account issues of safety and
efficacy, product profile, the proprietary position, the then current competitive
environment for such product and the likely timing of such product’s entry into the
market, the regulatory environment and status of such product, and other relevant
scientific, technical and commercial factors.

	 
	 	1.10.	 	“Compound” means the compound designated by PFIZER as PF-01367338, that
inhibits poly (ADP-ribose) polymerase (“PARP”) and all salts, polymorphs and
formulations thereof.

	 
	 	1.11.	 	“Control” or “Controlled” means, with respect to any Intellectual Property
Rights, the legal authority or right (whether by ownership, license or otherwise) of a
Party to grant a license or a sublicense of or under such Intellectual Property Rights
to the other Party without breaching the terms of any agreement with a Third Party.
For clarity, if a Party only can grant a license or sublicense to Intellectual
Property, or provide access to a material or document, of a limited scope due to an
encumbrance imposed by a Third Party, “Control” or “Controlled” shall be construed to
so limit the license or sublicense to such Intellectual Property or the provision of,
or provision of access to, such materials or documents (as applicable).

	 
	 	1.12.	 	“Develop” or “Development” means to conduct research and development
activities (including related manufacturing activities) under conditions designed to
yield data suitable for inclusion in an application for Regulatory Approval of a
Product by the FDA or a comparable agency in another country or regulatory jurisdiction
within the Territory.

- 2 -

 

	 	1.13.	 	“Distributor” means a Third Party, other than a sublicensee of LICENSEE, that
(i) purchases any Products in finished form from or at the direction of LICENSEE or any
of its Affiliates or sublicensees, and (ii) has the right to Commercialize such
Products in one or more regions, or has an option to do the foregoing.

	 
	 	1.14.	 	“Existing Trials” means the PFIZER 1014 Study and the Other Compound Studies.

	 
	 	1.15.	 	“FDA” means the United States Food and Drug Administration, or a successor
federal agency thereto.

	 
	 	1.16.	 	“Field” means all human and animal therapeutic, prophylactic and diagnostic
uses of the Product, including the treatment of human disease with the Product.

	 
	 	1.17.	 	“First Commercial Sale” means with respect to a Product, the first sale for
use or consumption of the Product following receipt of Regulatory Approval for such
Product in a country in the Territory.

	 
	 	1.18.	 	“GAAP” means the generally accepted accounting principles in the United
States, consistently applied.

	 
	 	1.19.	 	“IND” means: (a) an investigational new drug application filed with the FDA
for authorization for the investigation of the Product, and (b) any of its foreign
equivalents as filed with the applicable Regulatory Authorities in other countries or
regulatory jurisdictions in the Territory, as applicable.

	 
	 	1.20.	 	“Indication” for a Product means the use of such Product for treating a
particular disease or medical condition.

	 
	 	1.21.	 	“Intellectual Property Rights” means all trade secrets, copyrights, patents
and other patent rights, Trademarks, moral rights, know-how and any and all other
intellectual property or proprietary rights now known or hereafter recognized in any
jurisdiction.

	 
	 	1.22.	 	“Know-How” means all confidential and proprietary information and data
Controlled by PFIZER as of the Effective Date related to the Compound or related to the
Product as it exists on the Effective Date contained within the Documentation
transferred pursuant to Section 3.

	 
	 	1.23.	 	“Licensed Technology” means collectively, the Patent Rights and Know-How.

	 
	 	1.24.	 	“MAA” means a Marketing Authorization Application filed with the EMA under the
centralized European procedure (including amendments and supplements thereto).

	 
	 	1.25.	 	“Milestone” means each milestone as set forth in Sections 5.1.2 and 5.1.3.

	 
	 	1.26.	 	“NDA/BLA” means: (a) a new drug application or a new biologic
license application filed with the FDA for authorization for marketing the Product, and
(b)

- 3 -

 

	 	 	 	any of its foreign equivalents as filed with the applicable Regulatory Authorities
in other countries or regulatory jurisdictions in the Territory, as applicable.

	 
	 	1.27.	 	“Net Sales” means the gross amount invoiced by or on behalf of LICENSEE, its
Affiliates and their respective sublicensees (each a “Selling Party”) for sales of the
Product, less the following deductions if and to the extent they are included in the
gross invoiced sales price of the Product or otherwise directly incurred by LICENSEE,
its Affiliates and their respective sublicensees with respect to the sale of the
Product: (a) rebates, quantity and cash discounts, and other usual and customary
discounts to customers, (b) taxes and duties paid, absorbed or allowed which are
directly related to the sale of the Product, (c) credits, allowances, discounts and
rebates to, and chargebacks for spoiled, damaged, out-dated, rejected or returned
Product, (d) actual freight and insurance costs incurred in transporting the Product to
customers, provided that in no event shall deductions for freight and insurance exceed
three percent (3%) of the gross amount invoiced, (e) discounts or rebates or other
payments required by Applicable Law, including any governmental special medical
assistance programs, and (f) customs duties, surcharges and other governmental charges
incurred in connection with the exportation or importation of the Product.
Subsections (a) through (f) shall be collectively referred to as “Deductions”.

	 
	 	 	 	The following principles shall apply in the calculation of Net Sales:

 

	 	 	 	1.27.1. Products will be considered “sold” when a sale by a Selling Party is
recognized in accordance with revenue recognition policies mandated by GAAP.

	 
	 	 	 	1.27.2. Nothing herein will prevent a Selling Party from selling, distributing or
invoicing Products at a discounted price for shipments to Third Parties in
connection with clinical studies, compassionate sales, or an indigent program or
similar bona fide arrangements in which the Selling Party agrees to forego a normal
profit margin for good faith business reasons.

	 
	 	 	 	1.27.3. A sale or transfer of Products between any of the Selling Parties will not
result in any Net Sales, and Net Sales instead will be based on subsequent sales or
distribution to a non-Selling Party, unless such Products are consumed by a Selling
Party in the course of its commercial activities. Sales to Distributors shall be
treated identically to any other sales to Third Parties

	 
	 	 	 	1.27.4. In the case of any sale or other disposal of Product for non-cash
consideration, Net Sales shall be calculated as the fair market price of the
Product in the country of sale or disposal. Notwithstanding the foregoing,
provision of the Product for the purpose of conducting pre-clinical or clinical
research shall not be deemed to be a sale, so long as the Product is provided at a
price which does not exceed the reasonably estimated cost of production and
distribution thereof.

	 
	 	 	 	1.27.5. Net Sales means, in the case of “Combination Product” which is defined as
any pharmaceutical product containing: (a) the Product and (b) one or more other
active therapeutically active ingredients, which is not a Product:

- 4 -

 

	 	(a)	 	if LICENSEE and/or its Affiliates and/or any Third Party
separately sells in such country during such year when it sells such
Combination Product both (1) one or more Products as a single chemical entity,
and (2) other products containing active ingredient(s) as a single entity that
are also contained in such Combination Product, the Net Sales attributable to
such Combination Product during such year shall be calculated by multiplying
actual Net Sales of such Combination Product by the fraction A/(A+B) where: A
is LICENSEE’s (or its Affiliates or Third Parties, as applicable) average Net
Sales price per daily dose during such year for each Product in such
Combination Product in such country and B is the sum of the average of
LICENSEE’s (or its Affiliates or Third Parties, as applicable) Net Sales price
per daily dose during such year in such country, for each product(s)
containing, the active ingredient(s) in such Combination Product (other than
the Product);

	 
	 	(b)	 	if LICENSEE and/or its Affiliates and/or any Third Party
separately sells, in such country during such year when it sells such
Combination Product, one or more Products as a single chemical entity but do
not separately sell, in such country, other products containing active
ingredient(s) that are also contained in such Combination Product, the Net
Sales attributable to such Combination Product during such year shall be
calculated by multiplying the Net Sales of such Combination Product by the
fraction A/C where: A is LICENSEE’s (or its Affiliates or Third Parties, as
applicable) average Net Sales price per daily dose during such year for each
Product in such Combination Product in such country, and C is LICENSEE’s (or
its Affiliates or Third Parties, as applicable) average Net Sales price per
daily dose during such year for the Combination Product in such country; and

	 
	 	(c)	 	if LICESEE and/or its Affiliates and/or Third Parties do not
separately in such country during such year sell each Product contained in the
Combination Product, then the Net Sales attributable to such Combination
Product shall be D/(D+E) where D is the fair market value of the portion of the
Combination Product that contains the Product and E is the fair market value of
the portion of the Combination Product containing the other active
ingredient(s) included in such Combination Product, as such fair market values
are determined by mutual agreement of the parties.

	 

	 	 	 	1.27.6. Net Sales shall be calculated in accordance with GAAP generally and
consistently applied.

	 	1.28.	 	“Other Compound Studies” means those studies in addition to the Pfizer 1014
Study that are listed in Schedule B-1.

	 
	 	1.29.	 	“Patent Rights” means all of PFIZER’S rights in patents and patent
applications listed in Schedule A in so far as they related to the Compound, and all
continuations, divisionals and renewals of such patents and patent applications, any
continuations-in-part (to the extent the claims thereof are entirely supported by the
patents and patent applications to which it claims priority), and any other subsequent
filings in

- 5 -

 

	 	 	 	any country in the Territory, in each case to the extent claiming priority from such
patents and patent applications, all letters of patent granted with respect to any
of the foregoing, and all patents of addition, restorations, extensions,
supplementary protection certificates, registration or confirmation patents,
reissues and re-examinations of any of the foregoing. “Patent Rights” shall also
include any patent applications or patents referred to in Section 14.1.4 of this
Agreement.

	 
	 	1.30.	 	“Person” means an individual, corporation, partnership, limited liability
company, trust, business trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, governmental authority or
any other form of entity not specifically listed herein.

	 
	 	1.31.	 	“PFIZER 1014 Study” means the PFIZER sponsored clinical study of the Compound
known as A4991014.

	 
	 	1.32.	 	“Product” means any and all pharmaceutical, diagnostic or veterinary products:
(i) for which the manufacture, use, offer for sale, sale, import or export would, if
not for the license granted to LICENSEE, infringe a valid claim of a Patent Right in
the country for which such products are used, offered for sale, sold, manufactured or
imported; or (ii) that contain the Compound.

	 
	 	1.33.	 	“Regulatory Approval” means, with respect to the Product in any country or
jurisdiction, any approval (including where required, pricing and reimbursement
approvals), registration, license or authorization that is required by the applicable
Regulatory Authority to market and sell the Product in such country or jurisdiction.

	 
	 	1.34.	 	“Regulatory Authority” means any governmental agency or authority responsible
for granting Regulatory Approvals for the Product in the Territory.

	 
	 	1.35.	 	“Regulatory Filings” means, with respect to the Product, any submission to a
Regulatory Authority of any appropriate regulatory application, including, without
limitation, any IND, NDA/BLA, any submission to a regulatory advisory board, any
marketing authorization application, and any supplement or amendment thereto.

	 
	 	1.36.	 	“Royalty Term” means, on a Product-by-Product and country-by country basis,
the period commencing on the First Commercial Sale of the Product in a country and
expiring upon the later of: (a) expiration or abandonment of the last Valid Claim of
the Patent Rights which covers the Use of the Product in such country , or (b) ten (10)
years following the date of First Commercial Sale of the Product in such country.

	 
	 	1.37.	 	“Territory” means worldwide.

	 
	 	1.38.	 	“Third Party” means any Person other than a Party or an Affiliate of a Party.

	 
	 	1.39.	 	“Trademarks” has the meaning as set forth in Section 13.4.5(c).

	 
	 	1.40.	 	“Use” means to make, have made, use, sell, offer for sale, and import and export.

- 6 -

 

	 	1.41.	 	“Valid Claim” means either: (a) a claim of an issued and unexpired patent
included within the Patent Rights, which has not been permanently revoked or declared
unenforceable or invalid by an unreversed and unappealable or unreversed and unappealed
decision of a court or other appropriate body of competent jurisdiction, or (b) a claim
of a pending patent application included within the Patent Rights, which claim was
filed in good faith and has not been abandoned or finally disallowed without the
possibility of appeal or refiling of such application.

	2.	 	LICENSE GRANT

	 	2.1.	 	License Grant.

	 

	 	 	 	2.1.1. Patent Rights. Subject to the terms and conditions of this Agreement PFIZER
hereby grants to LICENSEE an exclusive (even as to PFIZER except as expressly
provided in Section 2.3 below (“Retained Rights”)), sublicensable (subject to
Section 2.2), royalty-bearing right and license under the Patents Rights to Use the
Product in the Field within the Territory. For clarity, the license rights include
an exclusive sub-license of PFIZER’s rights under the Collaboration and License
Agreement and the Collaboration Agreement.

	 
	 	 	 	2.1.2. Know How. Subject to the terms and conditions of this Agreement including
the Retained Rights, PFIZER hereby grants to LICENSEE a non-exclusive,
sublicensable (subject to Section 2.2), royalty-bearing right and license to use
the Know-How for the purpose of the Development and Commercialization of the
Product in the Field within the Territory.

	 
	 	 	 	2.1.3. Affiliates. To the extent that any of the Licensed Technology is Controlled
by an Affiliate of PFIZER, then promptly following the Effective Date, PFIZER shall
procure that such Affiliate undertakes all necessary actions to give effect to the
licenses granted under this Section. In addition, during the course of the
implementation by the Parties of the Transition Plan, to the extent (i) requested
by LICENSEE, (ii) reasonably practicable and (iii) any such assignment would not
jeopardize any intellectual property rights of PFIZER, the Parties will seek to
obtain the consent of the Third Party to the Collaboration Agreement and the
Collaboration and License Agreement to an assignment of one or both of such
agreements to LICENSEE.

	 

	 	2.2.	 	Sublicense Rights. LICENSEE may, subject to Section 2.6, sublicense the rights
granted to it by PFIZER under this Agreement to any of its Affiliates or to any Third
Party which has reasonably demonstrated the necessary financial and technical capacity
to carry out the LICENSEE’s obligations under this Agreement. Any and all sublicenses
shall be subject to the following requirements:

	 

	 	 	 	2.2.1. All sublicenses shall be subject to and consistent with the terms and
conditions of this Agreement and shall: (a) preclude the assignment or further
sub-licensing of such sublicense without the prior written approval of PFIZER
(provided, however, that the foregoing restriction on further
sublicensing shall not apply if the sub-licensee is a publicly-traded company with
a market capitalization

- 7 -

 

	 	 	 	of at least $1 Billion at the time of the proposed transaction), and (b) include
PFIZER as a third party beneficiary under the sublicense with the right to enforce
the terms of such sublicense. In no event shall any sublicense relieve LICENSEE of
any of its obligations under this Agreement.

	 
	 	 	 	2.2.2. LICENSEE shall furnish to PFIZER a true and complete copy of each sublicense
agreement and each amendment thereto, within thirty (30) days after the sublicense
or amendment has been executed.

	 
	 	2.3.	 	Retained Rights. LICENSEE acknowledges and agrees that PFIZER retains the
right to make, have made and use and have used the Licensed Technology for all internal
research purposes and LICENSEE hereby grants to PFIZER a worldwide, irrevocable,
non-exclusive, fully paid up license (with the right to sub-license to any Affiliate
without the need for LICENSEE’S consent) to such Licensed Technology for such purposes
without the consent of LICENSEE.

	 
	 	2.4.	 	Residuals. PFIZER may use for any purpose the Residuals resulting from access
to or work with the Compound, Product and Know-How. As used herein, “Residuals” means
information in non-tangible form which may be retained by persons who have had access
to the Compound, Product and Know-How, including ideas, concepts, know-how or
techniques contained therein.

	 
	 	2.5.	 	No Additional Rights. Nothing in this Agreement shall be construed to confer
any rights upon LICENSEE by implication, estoppel, or otherwise as to any technology or
Intellectual Property Rights of PFIZER or it Affiliates other than the Licensed
Technology.

	 
	 	2.6.	 	Rights of First Negotiation. If LICENSEE decides, other than as part of a
merger or sale of LICENSEE as a whole or a sale of substantially all of the assets of
LICENSEE , to seek to sublicense the Licensed Technology to a Third Party in any one of
the following territories: US, UK, Germany, France, Spain, Italy, China or Japan for
Development and/or Commercialization of a Product, then LICENSEE shall first notify
PFIZER in writing of its plans for such a sublicense, including the specific territory
to be covered (“Transaction Notice”). If PFIZER desires to evaluate whether to seek
such sublicense in such notified territory (the “Subject Territory”) for itself, then
PFIZER shall notify LICENSEE within thirty (30) days of receipt of the Transaction
Notice (“Negotiation Notice”). For the sixty (60) days following receipt of the
Negotiation Notice (“Exclusivity Period”), PFIZER shall have the exclusive right to
negotiate an exclusive sublicense to the Product in the Subject Territory with
LICENSEE, such negotiations to include at least one face-to-face meeting and to be
conducted on a good faith basis using reasonable efforts. If PFIZER does not provide
such Negotiation Notice to LICENSEE, does not provide a written proposal during the
Exclusivity Period, or the two Parties do not come to agreement during the Exclusivity
Period, then LICENSEE shall be free to pursue such a sublicense with any Third Party;
provided, however, that LICENSEE shall not be entitled to subsequently grant
Development or Commercialization rights to a Third Party for the Subject Territory
unless, in the reasonable and informed good faith judgment of the Board of Directors of LICENSEE, the terms and 

- 8 -

 

	 	 	 	provisions of the proposed agreement with such Third Party
are, in the aggregate, more favorable to LICENSEE than the terms and provisions set
forth in the last offer submitted in writing by PFIZER to LICENSEE in the course of
the negotiations between PFIZER and LICENSEE.

	3.	 	TRANSFER ACTIVITIES

	 	3.1.	 	Transition Coordinators. Each Party shall appoint one Transition coordinator
(each a “Transition Coordinator” and collectively, the “Transition Coordinators”) who
shall serve as the principal contacts for PFIZER and LICENSEE for matters relating to
the implementation of the Technical Transfer Transition Plan (“Transition Plan”) and
shall have the authority from the Party that designated such Coordinator to modify the
Transition Plan. The initial Transition Coordinator for LICENSEE
shall be ***,
and the initial Transition Coordinator for PFIZER shall be ***. Any
Transition Coordinator may be replaced by the Party so appointing him or her from time
to time upon notice to the other Party.

	 
	 	 	 	The Transition Coordinators shall meet, in person or by telephone, not less than
once every week during the first three (3) months of the implementation of the
Transition Plan to (i) review the progress being made under the Transition Plan,
(ii) discuss future activities to be conducted under the Transition Plan and the
extent to which additional resources need to be applied by either Party or both to
complete the transition, and (iii) review and agree upon any necessary or desired
revisions to the Transition Plan. Upon the request of either Transition
Coordinator, other personnel from a Party may attend and participate in such
meetings. It is the objective of the Parties, working through their Transition
Coordinators, and in accordance with the terms and conditions of this Agreement
including the Schedules hereto, to insure as smooth and efficient a transition from
PFIZER to LICENSEE as reasonably practical of all relevant documentation, materials,
contractual obligations and regulatory responsibilities related to the Compound, the
Product and the Existing Trials.

	 
	 	3.2.	 	Initial Transfer. PFIZER shall use reasonable efforts to: (a) make available
to LICENSEE currently available records as set forth in Schedule B which exist
and are Controlled by PFIZER as of the Effective Date and are necessary for LICENSEE to
continue Developing the Product (collectively, “Documentation”), and (b) perform other
activities with respect to Regulatory Filings and/or Regulatory Approvals as set forth
in Schedule B (where the activities under subsections (a) and (b) shall be
collectively referred to as “Transfer Activities”). PFIZER shall use reasonable
efforts to perform the Transfer Activities and complete such Activities within the time
periods specified in Schedule B, and PFIZER shall provide written notice to
LICENSEE upon completion of such efforts (“PFIZER Transfer Notice”).

	 
	 	3.3.	 	Existing Trials and Agreements. In connection with its efforts to Develop the
Product, LICENSEE shall assume all financial responsibility, at its sole cost, for the
Existing Trials with effect from the Effective Date. For clarity, the obligations in
the preceding sentence include the assumption of financial responsibility for
outstanding financial obligations related to the Existing Trials as particularized in
the Third Party

- 9 -

 

	 	 	 	Agreements set out in Schedule B-1. In addition, LICENSEE shall assume
operational responsibility for the Existing Trials under the time lines and
mechanisms set out in Section 4.3.1 and Schedule B and the Transition Plan that will
be developed under the terms of Schedule B.

	 
	 	3.4.	 	Follow-up Period. For a period of six (6) months following LICENSEE’s receipt
of the PFIZER Transfer Notice, if LICENSEE discovers or learns of any incomplete
Transfer Activities, LICENSEE shall provide written notice to PFIZER, and PFIZER shall
use reasonable efforts to perform such Transfer Activities provided that PFIZER’s
efforts to engage in the Transfer Activities under this Section 3 shall not exceed a
total of forty (40) hours.

	4.	 	DEVELOPMENT, MANUFACTURING, REGULATORY AND COMMERCIALIZATION

	 	4.1.	 	Development.

	 
	 	 	 	4.1.1. LICENSEE shall itself, or through its Affiliates or sublicensees, use
Commercially Reasonable Efforts to Develop the Product in the Territory, and
LICENSEE shall undertake all Development activities at its sole expense. Without
limiting the foregoing, in connection with its efforts to Develop the Product,
LICENSEE shall bear all responsibility and expense for filing Regulatory Filings in
LICENSEE’s name and obtaining Regulatory Approval for the Product. LICENSEE’s
Development activities will be undertaken in accordance with a Development plan
(the “Development Plan”), the initial Development Plan being attached to the
Agreement as Schedule D (the “Initial Development Plan”). PFIZER acknowledges that
(a) the Initial Development Plan has been based on the due diligence carried out by
LICENSEE prior to the Effective Date, largely utilizing information furnished to
LICENSEE by PFIZER; (b) such Plan is predicated, in part, on clinical data that has
not yet been generated; and (c) such Plan is subject to revision from time to time
to take into account, among other factors: safety or efficacy concerns, matters
related to Patent coverage, or issues related to present or future marketability or
profitability, including existing or anticipated competition, and that such
revisions may include seeking regulatory approval for different indications than
are contained in the Initial Development Plan. Each Development Plan or amendment
shall be treated by both Parties as a good faith statement of LICENSEE’s intentions
for the Development of the Product, but such Development Plan shall not be deemed
to be a contractual commitment by LICENSEE to undertake all of the efforts
described in such Plan or to refrain from making adjustments to such Plan that, in
LICENSEE’s reasonable judgment, are necessary in light of factors described in the
preceding sentence. LICENSEE shall provide to PFIZER reports regarding LICENSEE’s
progress and future plans, including amendments to the Development Plan, every six
(6) months during the terms of this Agreement, and Pfizer will be provided with an
opportunity to comment on all amendments to the Development Plan as well as all
Development and Commercialization activities.

- 10 -

 

	 	 	 	4.1.2. Notwithstanding the provisions of the foregoing Section 4.1.1, LICENSEE
shall, at a minimum, complete the PFIZER 1014 Study as well as initiating and
completing the Phase I Monotherapy Study as described in Schedule D. The
initiation of the Phase I Monotherapy Study will occur no later than by the end of
the first quarter of 2012.

	 
	 	4.2.	 	Commercialization. LICENSEE shall itself, or through its Affiliates,
sublicensees or Distributors, use Commercially Reasonable Efforts to Commercialize the
Product in the U.S., the European Union, major Asian markets (which shall include
China, Japan and South Korea) and in each other country within the Territory where
Commercializing the Products would be Commercially Reasonable. LICENSEE shall
undertake such activities at its sole expense.

	 
	 	4.3.	 	Regulatory and Pharmacovigilance.

	 
	 	 	 	4.3.1. Within ten (10) days after the Effective Date, PFIZER shall notify the
appropriate Regulatory Authorities and any necessary Third Party that it is
transferring responsibility for the PFIZER 1014 Study so as to permit an assignment
to LICENSEE of the existing IND for the Product and its foreign Regulatory
Authority counterparts as promptly as possible.

	 
	 	 	 	4.3.2. During the implementation of the Transition Plan, the safety units of each
of the Parties shall discuss whether or not it may be necessary to put in place a a
written agreement for exchanging adverse event and other safety information
relating to the Product prior to PFIZER’s transfer of the existing IND to LICENSEE,
and if they agree that such an agreement is necessary, they shall promptly meet and
agree upon such an agreement (‘the Pharmacovigiance Agreement”). Such
Pharmacovigilance Agreement shall ensure that adverse events and other safety
information is exchanged upon terms that will permit each Party to comply with
Applicable Laws and requirements of Regulatory Authorities

	 
	 	 	 	4.3.3. In the event that one or more Regulatory Authorities contact PFIZER
regarding an audit of any of the research and development done prior to the
Effective Date, by, or under the direction of, PFIZER regarding the Compound or the
Product, PFIZER shall promptly notify LICENSEE and shall coordinate with LICENSEE
and provide reasonable co-operation to furnish or provide access to such Regulatory
Authority as may be required to comply with the audit so requested.

	 
	 	4.4.	 	Manufacturing. Subject to Section 2.3 and subject to any rights needed by
PFIZER in order to complete the manufacturing of drug substance or drug product of the
Product for LICENSEE contemplated by this Agreement, LICENSEE shall have the sole right
to manufacture, or have manufactured, Products, and it shall be entitled to use, and to
sublicense the manufacturing rights under the Patent Rights for such purposes. Except
as provided below, LICENSEE shall be responsible for all aspects of manufacturing of
the Product.

- 11 -

 

	 	 	 	4.4.1. PFIZER shall transfer free of charge (except for transportation costs which
shall be borne by LICENSEE) existing inventories of API inventory and bulk drug
inventory (as further particularized in Schedule E hereto) to LICENSEE including
documentation to support the use of those materials in clinical trials.

	 
	 	 	 	4.4.2. PFIZER shall also provide background research information and technical
assistance as reasonably requested by LICENSEE, including analytical methods
utilized by PFIZER in the manufacture of the drug substance and drug product, to
support development of the Product in the Field and in the Territory All
manufacturing development expenses incurred from and after the Effective Date shall
be the responsibility of LICENSEE.

	 
	 	 	 	4.4.3. Prior to the Effective Date, PFIZER had already scheduled a production run
of drug product of the Product (as further particularized in Schedule E hereto and
PFIZER hereby undertakes to complete such production run and sell such drug product
to LICENSEE in the quantities, at a price and with scheduled delivery dates as set
forth in Schedule E if requested by LICENSEE.

	 
	 	 	 	4.4.4. In addition, PFIZER hereby undertakes to manufacture additional drug
substance and drug product of the Product for LICENSEE (as further particularized
in Schedule E hereto) and to sell such drug product to LICENSEE in the quantities,
at a price and with scheduled delivery dates as set forth in Schedule E if
requested by LICENSEE.

	5.	 	PAYMENT TERMS

	 	5.1.	 	Payment Terms.

	 
	 	 	 	5.1.1. Equity. In partial consideration of the licenses and rights granted to
LICENSEE hereunder, LICENSEE shall, contemporaneously with the execution of this
Agreement and pursuant to a Convertible Note Agreement signed by PFIZER and
LICENSEE on the date hereof, issue to PFIZER seven million dollars ($7,000,000) of
aggregate principal amount of its 5% Convertible Promissory Notes due 2012, in the
form attached to such Convertible Note Agreement.

	 
	 	 	 	5.1.2. Milestone Payments. LICENSEE shall notify PFIZER as soon as practicable
upon achievement of each Milestone. In further consideration of the licenses and
rights granted to LICENSEE, within fifteen (15) days upon achievement of each
Milestone set forth below, LICENSEE shall pay to PFIZER the corresponding
non-creditable and non-refundable milestone payment (each, a “Milestone Payment”).

- 12 -

 

	 	(i)	 	Development and Regulatory Milestones.

	 	 	 	 	 	 
	 
	 	DEVELOPMENT	 	 	MILESTONE	 
	 	AND REGULATORY MILESTONES	 	 	PAYMENT	 
	 	PAYABLE UNDER THE	 	 	 	 
	 	COLLABORATION AND LICENSE AGREEMENT	 	 	 	 
	 	Commencement of Pivotal Registration Study

	 	 	US$***	 
	 	Acceptance for filing by the FDA of an NDA for the first Indication

	 	 	US$***	 
	 	Acceptance for filing by the EMA of an MAA for the first Indication

	 	 	US$***	 
	 	Grant of the first NDA approval of a Product in the USA

	 	 	US$***	 
	 	Granting of the first European approval located in a country located in the European Union

	 	 	US$***	 
	 

	 	(ii)	 	Product Approval and Sales Milestones

	 	 	 	 	 	 
	 
	 	PRODUCT APPROVAL	 	 	MILESTONE	 
	 	AND SALES MILESTONES	 	 	PAYMENT	 
	 	Upon FDA approval of an NDA for 1st Indication in US

	 	 	US$***	 
	 	Upon EMA approval of an MAA for 1st Indication in EU

	 	 	US$***	 
	 	Upon FDA approval of an NDA for a 2nd Indication in US

	 	 	US$***	 
	 	Upon EMA approval of an MAA for a 2nd Indication in EU

	 	 	US$***	 
	 	Upon FDA approval of an NDA for a 3rd Indication in US

	 	 	US$***	 
	 	Upon EMA approval of an MAA for a 3rd Indication in EU

	 	 	US$***	 
	 	The completion of the Calendar Year in which Net Sales first
exceed $***

	 	 	US$***	 
	 	The completion of the Calendar Year in which Net Sales first
exceed $***

	 	 	US$***	 
	 	The completion of the Calendar Year in which Net Sales first
exceed $***

	 	 	US$***	 
	 

- 13 -

 

	 	(b)	 	As used, herein:

	 	(i)	 	“Commencement” when used with respect to a
clinical trial, means the first dosing of the first patient for such
trial.

	 
	 	(ii)	 	“Pivotal Registration Study” means a clinical
study designed to provide the efficacy data required to enable an NDA
to be filed in the USA or an MAA to be filed in the EU.

	 	(c)	 	For the avoidance of doubt: (i) each Milestone Payment shall be
payable only once upon achievement of the applicable Milestone; and (ii)
satisfaction of a Milestone by a sublicensee or assignee of, or Third Party
retained by, LICENSEE or its Affiliates shall be deemed to have been satisfied
by LICENSEE for purposes of this Section 5.1.2.

	 	5.1.3. Royalty Payments.

	 	(a)	 	In consideration of the licenses and rights granted to LICENSEE
hereunder, LICENSEE shall pay to PFIZER the royalties of *** percent (*** %) on
Net Sales during the Royalty Term.

	 
	 	(b)	 	In addition, through the payments made to PFIZER below in this
sub-clause 5.1.3(b) LICENSEE shall assume responsibility for payment of the
following royalties under the Collaboration and License Agreement:

	 
	 	 	 	*** % of Net Sales in any Calendar Year up to $*** Million;

	 
	 	 	 	*** % of Net Sales in any Calendar Year over $*** Million and up to $***
Million; and

	 
	 	 	 	*** % of Net Sales in any Calendar Year over $*** Million

	 
	 	 	 	For the purposes of this sub-clause 5.1.3(b) Net Sales shall have the
meaning set out in the Collaboration and License Agreement.

	 
	 	(c)	 	LICENSEE shall pay to PFIZER the applicable Royalties set out
in sub-sections (a) and (b) above (collectively “Royalties”) within thirty (30)
days following the expiration of each Calendar Quarter after the date of the
First Commercial Sale. Royalties will be payable on a country by country basis
commencing as of the First Commercial Sale of a Product in each country until
expiration of the Royalty Term for such Product in each country.

	 
	 	(d)	 	If LICENSEE (a) reasonably determines in good faith that, in
order to avoid infringement of any patent not licensed hereunder, it is
reasonably necessary to obtain a license from a Third Party in order to sell or
offer for sale a Product in a country in the Territory and to pay a royalty
under such license (including in connection with the settlement of a patent
infringement claim),

 

- 14 -

 

	 	 	 	or (b) shall be subject to a final court or other binding order or ruling
requiring any payments, including the payment of a royalty to a Third Party
patent holder in respect of sales of any Product in a country in the
Territory, then*** of such third party royalties shall be deductible from
the amount of LICENSEE’s royalty payments under Section 5.1.3 (a) with
respect to Net Sales for such Product in such country, provided, however,
that in no event will a deduction, or deductions, under this Section 5.1(d),
in the aggregate, reduce any royalty payment made by LICENSEE under Section
5.1.3(a) in respect of Net Sales of such Product by more than ***.

	 
	 	(e)	 	All payments shall be accompanied by a report that includes
reasonably detailed information regarding a total monthly sales calculation of
gross sales of Products on a country by country basis and Net Sales of Product
(including all Deductions) and all Royalties payable to PFIZER for the
applicable Calendar Quarter (including any foreign exchange rates employed).

	 	 	 	5.1.4. Other Payments. LICENSEE shall pay to PFIZER any other amounts due under
this Agreement within thirty (30) days following receipt of invoice.

	 
	 	 	 	5.1.5. Late Payments. Any late payments shall bear interest, to the extent
permitted by law, at five percent (5%) above the Prime Rate of interest as reported
in the Wall Street Journal on the date payment is due.

	 
	 	5.2.	 	Payment Method.

	 
	 	 	 	5.2.1. With respect to Net Sales invoiced in U.S. dollars, the Net Sales and the
amounts due for Royalties hereunder will be expressed in U.S. dollars. With respect
to Net Sales invoiced in a currency other than U.S. dollars, payments will be
calculated based on currency exchange rates for the Calendar Quarter for which
remittance is made for Royalties. Conversion of Net Sales recorded in local
currencies to U.S. dollars will be performed in a manner consistent with PFIZER’s
normal practices used to prepare its audited financial statements for external
reporting purposes, provided that such practices use a widely accepted source of
published exchange rates. For purposes of calculating the Net Sales thresholds set
forth in Sections 5.1.2 and 5.1.3(b), the aggregate Net Sales with respect to each
Calendar Quarter within a Calendar Year will be calculated based on the currency
exchange rates for the Calendar Quarter in which such Net Sales occurred, in a
manner consistent with the exchange rate procedures set forth in the immediately
preceding sentence.

	 
	 	 	 	5.2.2. All payments from LICENSEE to PFIZER shall be made by wire transfer in U.S.
Dollars to the credit of such bank account as may be designated by PFIZER in
writing to LICENSEE. Any payment which falls due on a date which is not a Business
Day may be made on the next succeeding Business Day.

 

- 15 -

 

	 	5.3.	 	Taxes.

	 
	 	 	 	5.3.1. It is understood and agreed between the Parties that any amounts payable by
LICENSEE to PFIZER hereunder are exclusive of any and all applicable sales, use,
VAT, GST, excise, property, and other taxes, levies, duties or fees (collectively,
“Taxes”) which shall be added thereon as applicable. LICENSEE shall be responsible
for billing and collection from its customers and remitting to the appropriate
taxing authority any and all Taxes which it is required to collect or remit. Each
Party shall be responsible for its own income and property taxes.

	 
	 	 	 	5.3.2. LICENSEE may withhold from payments due to PFIZER amounts for payment of any
withholding tax that is required by law to be paid to any taxing authority with
respect to such payments. LICENSEE will provide PFIZER all relevant documents and
correspondence, and will also provide to PFIZER any other cooperation or assistance
on a reasonable basis as may be necessary to enable PFIZER to claim exemption from
such withholding taxes and to receive a refund of such withholding tax or claim a
foreign tax credit. LICENSEE will give proper evidence from time to time as to the
payment of any such tax. The Parties will cooperate with each other in seeking
deductions under any double taxation or other similar treaty or agreement from time
to time in force. Such cooperation may include LICENSEE making payments from a
single source in the U.S., where possible. Apart from any such permitted
withholding and those deductions expressly included in the definition of Net Sales,
the amounts payable LICENSEE to PFIZER hereunder will not be reduced on account of
any taxes, charges, duties or other levies. Notwithstanding the foregoing, if
LICENSEE is required to make a payment to PFIZER subject to a deduction of
withholding tax (a “LICENSEE Withholding Tax Action”) then, the sum payable by
LICENSEE (in respect of which such deduction or withholding is required to be made)
shall be increased to the extent necessary to ensure that PFIZER receives a sum
equal to the sum which it would have received had no such LICENSEE Withholding Tax
Action occurred, if (i) such withholding or deduction obligation arises as a direct
result of any action by LICENSEE, including any assignment or sublicense, or any
failure on the part of LICENSEE to comply with applicable tax laws or filing or
record retention requirements, that has the effect of modifying the tax treatment
of the Parties hereto, and (ii) such tax cannot be recovered by PFIZER or credited
to PFIZER.

	 
	 	 	 	5.3.3. The Parties agree to cooperate and produce on a timely basis any tax forms
or reports, including an IRS Form W-8BEN, reasonably requested by the other Party
in connection with any payment made by LICENSEE to PFIZER under this Agreement.

	6.	 	RECORDS; AUDIT RIGHTS

	 	6.1.	 	Relevant Records.

	 
	 	 	 	6.1.1. Relevant Records. LICENSEE shall keep, and will cause each of its
Affiliates or sublicensees, as applicable, to keep, accurate books and records of
accounting for the purpose of calculating all Milestone Payments and Royalties

- 16 -

 

	 	 	 	(collectively, “Fees”) (collectively, “Relevant Records”). For the three (3) years
following the end of the Calendar Year to which each will pertain, such Relevant
Records will be kept by LICENSEE or such Affiliate or sublicensee at each of their
principal place of business.

	 
	 	 	 	6.1.2. Audit Request. At the request of PFIZER, LICENSEE shall, and, shall cause
each of its Affiliates or sublicensees to, permit PFIZER and its representatives
(including an independent auditor), at reasonable times and upon reasonable notice,
to examine the Relevant Records. Such examinations may not (i) be conducted for
any Calendar Year more than three (3) years after the end of such year, (ii) be
conducted more than once in any twelve (12) month period or (iii) be repeated for
any Calendar Year. Such audit shall be requested in writing at least seven (7)
days in advance, and shall be conducted during LICENSEE’s normal business hours and
otherwise in manner that minimizes any interference to LICENSEE’s business
operations.

	 
	 	 	 	6.1.3. Audit Fees and Expenses. PFIZER shall bear any and all fees and expenses it
may incur in connection with any such audit of the Relevant Records; provided,
however, in the event an audit reveals an underpayment of LICENSEE of more than
five percent (5%) as to the period subject to the audit, LICENSEE shall reimburse
PFIZER for any reasonable and documented out-of-pocket costs and expenses of the
audit within thirty (30) days after receiving invoices thereof.

	 
	 	 	 	6.1.4. Payment of Deficiency. Unless disputed as described below, if such audit
concludes that additional payments were owed or that excess payments were made
during such period, LICENSEE will pay the additional royalties or amounts or PFIZER
will reimburse such excess payments, with interest from the date originally due as
provided in Section 5.1.7, within sixty (60) days after the date on which a written
report of such audit is delivered to the Parties. In the event of a dispute
regarding such Relevant Records, the Parties will work in good faith to resolve the
disagreement. If the Parties are unable to reach a mutually acceptable resolution
of any such dispute within thirty (30) days, such dispute will be resolved in
accordance with Section 16.3.2. PFIZER shall treat all information subject to
review under this Section 6.1 in accordance with the confidentiality provisions of
Section 9 and the Parties will cause any auditor or arbitrator to enter into a
reasonably acceptable confidentiality agreement with LICENSEE obligating such firm
to retain all such financial information in confidence pursuant to such
confidentiality agreement.

	7.	 	INTELLECTUAL PROPERTY RIGHTS

	 	7.1.	 	Pre-existing IP. Subject only to the rights expressly granted to the other
Party under this Agreement, each Party shall retain all rights, title and interests in
and to any Intellectual Property Rights that are owned, licensed or sublicensed by such
Party prior to or independent of this Agreement.

	 
	 	7.2.	 	Developed IP. LICENSEE shall own all rights, title and interests in and to any
Intellectual Property Rights that are both: (a) related to the Product, and (b)

- 17 -

 

	 	 	 	conceived solely by LICENSEE, its Affiliates or sublicensees following the Effective
Date (collectively, “Developed IP”).

	 
	 	7.3.	 	Patent Prosecution and Maintenance of Patent Rights

 

	 	(a)	 	LICENSEE shall be responsible for filing, prosecuting
(including in connection with any reexaminations, oppositions and the like) and
maintaining the Patent Rights in the Territory. LICENSEE shall file, prosecute
and maintain the Patent Rights using qualified outside patent counsel and
foreign patent associates selected by LICENSEE; provided that
LICENSEE identifies such counsel for PFIZER in advance and PFIZER consents to
such counsel (such consent not to be unreasonably withheld or delayed).
LICENSEE shall be responsible for all costs and expenses in connection with
such filing, prosecution and maintenance; provided that if
LICENSEE provides PFIZER with a written request to abandon, or not file a
patent application included in, any of the Patent Rights at least sixty (60)
days in advance of the relevant deadline: (a) LICENSEE shall no longer be
responsible for such costs and expenses relating to filing, prosecuting and
maintaining (as applicable) such Patent Right; (b) PFIZER may, or may allow a
Third Party to, file, prosecute and maintain (in its sole discretion) such
Patent Right; (c) upon PFIZER’s request, LICENSEE shall promptly provide all
files related to filing, prosecuting and maintaining such Patent Right to
counsel designated by PFIZER; and (d) the term “Patent Rights” automatically
shall be modified to exclude such Patent Right as of the date LICENSEE provides
such written request to PFIZER.

	 
	 	(b)	 	Upon the written request of PFIZER, LICENSEE shall provide
PFIZER with (1) material correspondence with the relevant patent offices
pertaining to LICENSEE’s prosecution of the Patent Rights and (2) a report
detailing the status of all Patent Rights. Upon the written request of PFIZER,
LICENSEE shall provide PFIZER a reasonable opportunity to review and comment on
proposed material submissions to any patent office with respect to the Patent
Rights prior to submission and LICENSEE shall reasonably consider any comments
provided by PFIZER.

	8.	 	ACTUAL OR THREATENED INFRINGEMENT, DISCLOSURE OR MISAPPROPRIATION.

 

	 	(a)	 	Notification. Each Party shall promptly notify the
other Party in writing of its becoming aware of (a) any actual or threatened
infringement, misappropriation or other violation or challenge to the validity,
scope or enforceability by a Third Party of any Licensed Technology (“Third
Party Infringement”) or (b) initiation by a Third Party of an opposition
proceeding against any Patent Rights, or initiation by LICENSEE of an
opposition against a Third Party or any allegation by a Third Party that
Intellectual Property owned by it is infringed, misappropriated or violated by
the Development, Commercialization and/or Use of any Product (“Defense
Action”).

- 18 -

 

	 	(b)	 	LICENSEE shall have the first right (but not the obligation),
at its own expense, to control enforcement of the Licensed Technology against
any Third Party Infringement. Prior to commencing involvement in any such
suit, action or proceeding, LICENSEE shall consult with PFIZER and shall
consider PFIZER’s recommendations regarding the proposed suit, action or
proceeding, except to the extent delay would result in the loss of rights by
LICENSEE or PFIZER. LICENSEE shall give PFIZER timely notice of any proposed
settlement of any such suit, action or proceeding that LICENSEE controls and
LICENSEE shall not settle, stipulate to any facts or make any admission with
respect to any Third Party Infringement without PFIZER’s prior written consent
(not to be unreasonably withheld or delayed) if such settlement, stipulation or
admission would: (a) adversely affect the validity, enforceability or scope, or
admit non-infringement, of any of the Licensed Technology; (b) give rise to
liability of PFIZER or its Affiliates; (c) grant to a Third Party a license or
covenant not to sue under, or with respect to, any Intellectual Property
Controlled by PFIZER (including the Licensed Technology); or (d) otherwise
impair PFIZER’s, any of its Affiliates’ rights in any Licensed Technology or
PFIZER’s or any of its Affiliates’ rights in this Agreement.

	 
	 	(c)	 	PFIZER shall have the right (but not the obligation) to
control, enforcement of the Licensed Technology against any Third Party
Infringement if LICENSEE provides PFIZER with written notice that it is not
exercising its right to control such enforcement or if such Third Party does
not desist such Third Party Infringement or LICENSEE fails to initiate, or file
the relevant response to (as applicable), a suit, action or proceeding with
respect to such Third Party Infringement upon the earlier of: (a) expiration
of the ninety (90) day period following first receipt by either Party of notice
from the other Party of such Third Party Infringement or (b) fifteen (15) prior
to the deadline for filing, or filing the applicable response to (as
applicable), such suit, action or proceeding (including suits, actions or
proceedings based on a Third Party’s filing of a Paragraph IV Certification
under 21 CFR §314.94(a)(12)(i)(A)(4)).

	 
	 	(d)	 	Notwithstanding anything to the contrary herein, the Party that
is not controlling the suit, action or proceeding pertaining to enforcement of
the Licensed Technology against Third Party Infringement as described in this
Section 8 may, at its sole discretion and expense (subject to Section 8(f)),
join as a party to such suit, action or proceeding; provided
that such Party shall join as a party to such suit, action or
proceeding upon the reasonable request and expense of the Party controlling
such action if necessary for standing purposes. The Party that is not
controlling such a suit, action or proceeding shall have the right to be
represented by counsel (which shall act in an advisory capacity only, except
for matters solely directed to such Party) of its own choice and at its own
expense (subject to Section 8(f)) in any such suit, action or proceeding.

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	 	(e)	 	Any and all recoveries resulting from a suit, action or
proceeding relating to a claim of Third Party Infringement shall first be
applied to reimburse each Party’s costs and expenses in connection with such
suit, action or proceeding, with any remaining recoveries retained by the Party
that controlled such suit, action or proceeding pursuant to this Section 8(e)
(the “Remaining Recoveries”). Notwithstanding the foregoing, LICENSEE
shall pay PFIZER a Royalty in accordance with Section 5.1.3 on the Remaining
Recoveries retained or received by LICENSEE as if such Remaining Recoveries
retained or received by LICENSEE were Net Sales in the Calendar Year in which
the recoveries were retained or received.

	 
	 	(f)	 	Upon LICENSEE’s request, PFIZER shall reasonably cooperate with
LICENSEE, to the extent necessary to defend LICENSEE or any sublicensee of
LICENSEE in a Defense Action related to LICENSEE’s or its sublicensee’s Use of
the Compound (as such Compound exists as of the Effective Date) or the Know-How
(in accordance with Section 2). LICENSEE shall have all authority with respect
to any Defense Action, including the right to exclusive control of the defense
of any such suit, action or proceeding and the exclusive right to compromise,
litigate, settle or otherwise dispose of any such suit, action, or proceeding;
provided that LICENSEE shall keep PFIZER timely informed of the
proceedings and filings, and provide PFIZER with copies of all material
communications, pertaining to each Defense Action and LICENSEE shall not
settle, stipulate to any facts or make any admission with respect to any
Defense Action without PFIZER’s prior written consent (not to be unreasonably
withheld or delayed) if such settlement, stipulation or admission would (a)
adversely affect the validity, enforceability or scope, or admit infringement,
of any of the Licensed Technology; (b) give rise to liability of PFIZER or its
Affiliates; (c) grant to a Third Party a license or covenant not to sue under,
or with respect to, any Intellectual Property Controlled by PFIZER (including
the Licensed Technology); or (d) otherwise impair PFIZER’ or any of its
Affiliates’ rights in any Licensed Technology or PFIZER’s or any of its
Affiliates’ rights in this Agreement.

	9.	 	CONFIDENTIALITY

	 	9.1.	 	Definition. “Confidential Information” means the terms and provisions of this
Agreement and other proprietary information and data of a financial, commercial or
technical nature that the disclosing Party or any of its Affiliates has supplied or
otherwise made available to the other Party or its Affiliates, which are: (a) disclosed
in writing or (b) if disclosed orally, summarized in writing and provided to the
receiving Party after disclosure. All Know-How shall be considered PFIZER’s
Confidential Information

	 
	 	9.2.	 	Obligations. The receiving Party shall protect all Confidential Information
against unauthorized disclosure to Third Parties with the same degree of care as the
receiving Party uses for its own similar information, but in no event less than a
reasonable degree of care. The receiving Party may disclose the Confidential

- 20 -

 

	 	 	 	Information to its Affiliates, and their respective directors, officers, employees,
subcontractors, sublicensees, consultants, attorneys, accountants, banks and
investors (collectively, “Recipients”) who have a need-to-know such information for
purposes related to this Agreement, provided that the receiving Party shall hold
such Recipients to written obligations of confidentiality with terms and conditions
at least as restrictive as those set forth in this Agreement.

	 
	 	9.3.	 	Exceptions.

	 
	 	 	 	9.3.1. The obligations under this Section 9 shall not apply to any information to
the extent the receiving Party can demonstrate by competent evidence that such
information:

	 	(a)	 	is (at the time of disclosure) or becomes (after the time of
disclosure) known to the public or part of the public domain through no breach
of this Agreement by the receiving Party or any Recipients to whom it disclosed
such information;

	 
	 	(b)	 	was known to, or was otherwise in the possession of, the
receiving Party prior to the time of disclosure by the disclosing Party;

	 
	 	(c)	 	is disclosed to the receiving Party on a non-confidential basis
by a Third Party who is entitled to disclose it without breaching any
confidentiality obligation to the disclosing Party; or

	 
	 	(d)	 	is independently developed by or on behalf of the receiving
Party or any of its Affiliates, as evidenced by its written records, without
use or access to the Confidential Information.

	 	 	 	9.3.2. The restrictions set forth in this Section 9 shall not apply to any
Confidential Information that the receiving Party is required to disclose under
Applicable Laws or a court order or other governmental order or to enforce any
Patent Rights under Section 8, provided that the receiving Party: (a) provides the
disclosing Party with prompt notice of such disclosure requirement if legally
permitted, (b) affords the disclosing Party an opportunity to oppose or limit, or
secure confidential treatment for such required disclosure and (c) if the
disclosing Party is unsuccessful in its efforts pursuant to subsection (b),
discloses only that portion of the Confidential Information that the receiving
Party is legally required to disclose as advised by the receiving Party’s legal
counsel.

	 
	 	 	 	9.3.3. In the event that PFIZER wishes to assign, pledge or otherwise transfer its
rights to receive some or all of the Milestone Payments and Royalties payable
hereunder, PFIZER may disclose to a Third Party Confidential Information of
LICENSEE in connection with any such proposed assignment, provided that PFIZER
shall hold such Third Parties to written obligations of confidentiality with terms
and conditions at least as restrictive as those set forth in this Agreement.

	 
	 	 	 	9.3.4. In the event that LICENSEE wishes to enter into a sublicense in accordance
with Section 2, LICENSEE may disclose to a Third Party Confidential

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	 	 	 	Information of PFIZER in connection with any such proposed sublicense, provided
that LICENSEE shall hold such Third Parties to written obligations of
confidentiality with terms and conditions at least as restrictive as those set
forth in this Agreement.

	 
	 	9.4.	 	Right to Injunctive Relief. Each Party agrees that breaches of this Section 9
may cause irreparable harm to the other Party and shall entitle such other Party, in
addition to any other remedies available to it (subject to the terms of this
Agreement), the right to seek injunctive relief enjoining such action.

	 
	 	9.5.	 	Ongoing Obligation for Confidentiality. Upon expiration or termination of this
Agreement, the receiving Party shall, and shall cause its Recipients to, destroy,
delete or return (as requested by the disclosing Party) any Confidential Information of
the disclosing Party, except for one copy which may be retained in its confidential
files for archive purposes.

	10.	 	REPRESENTATIONS, WARRANTIES AND COVENANTS

	 	10.1.	 	Representations and Warranties by Each Party. Each Party represents and
warrants to the other Party as of the Effective Date that:

	 	(a)	 	it is a corporation duly organized, validly existing, and in
good standing under the laws of its jurisdiction of formation;

	 
	 	(b)	 	it has full corporate power and authority to execute, deliver,
and perform under this Agreement, and has taken all corporate action required
by Applicable Law and its organizational documents to authorize the execution
and delivery of this Agreement and the consummation of the transactions
contemplated by this Agreement;

	 
	 	(c)	 	this Agreement constitutes a valid and binding agreement
enforceable against it in accordance with its terms;

	 
	 	(d)	 	all consents, approvals and authorizations from all
governmental authorities or other Third Parties required to be obtained by such
Party in connection with this Agreement have been obtained; and

	 
	 	(e)	 	the execution and delivery of this Agreement and all other
instruments and documents required to be executed pursuant to this Agreement,
and the consummation of the transactions contemplated hereby do not and shall
not: (i) conflict with or result in a breach of any provision of its
organizational documents, (ii) result in a breach of any agreement to which it
is a party that would impair the performance of its obligations hereunder; or
(iii) violate any Applicable Law.

	 	10.2.	 	Representations and Warranties by PFIZER.

	 
	 	 	 	10.2.1. PFIZER represents and warrants to LICENSEE as of the Effective Date that:

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	 	(a)	 	PFIZER Controls the Patent Rights and the Know-How, and is
entitled to grant the licenses specified herein; PFIZER has not caused any
Patent Rights to be subject to any liens or encumbrances and PFIZER has not
granted to any Third Party any rights or licenses under any of the Patent
Rights or Know-How that would conflict with the licenses granted to Licensee
hereunder; and PFIZER does not hold Control any patents that dominate the
Patent Rights;

	 
	 	(b)	 	PFIZER is not subject to any royalty or similar payment
obligation to any Third Party with respect to the grant of rights to PFIZER to
practice the Licensed Technology, except as set forth in the Collaboration and
License Agreement (a true copy of which, including all amendments, has been
provided to LICENSEE). The Collaboration and License Agreement remains in full
force and effect and, to PFIZER’s Knowledge, Cancer Research Technology Limited
is not in material breach under the Collaboration and License Agreement. PFIZER
has paid all amounts due and payable under the Collaboration and License
Agreement to the extent accrued on or before the Effective Date and is not in
material breach of the Collaboration and License Agreement;

	 
	 	(c)	 	to its Knowledge, the Patent Rights have been procured from the
respective Patent offices in accordance with Applicable Law;

	 
	 	(d)	 	to its Knowledge, PFIZER has not received any communication
from a Third Party alleging that the Use of the Product in the Field within the
Territory infringes, misappropriates or otherwise violates the Intellectual
Property Rights of a Third Party;

	 
	 	(e)	 	to its Knowledge, there is no claim pending or threatened by
PFIZER alleging that a Third Party is or was infringing, misappropriating or
otherwise violating the Licensed Technology in the Field within the Territory;
and

	 
	 	(f)	 	PFIZER has not, up through and including the Effective Date,
Knowingly withheld any material information, including reports of Adverse Event
Experiences and warning letters from Regulatory Authorities, in PFIZER’s
possession from LICENSEE in connection with its due diligence relating to the
Compound, Products, this Agreement and the underlying transaction. To PFIZER’s
Knowledge, the clinical data related to Compound or Product that PFIZER has
provided to LICENSEE prior to the Effective Date was, when access was provided
to LICENSEE, up-to-date and accurate in all material respects and PFIZER has
provided LICENSEE with any material updates to such clinical data that have
occurred since the time such access was provided to LICENSEE.

	 	 	 	10.2.2. As used in Section 10.2.1, “Knowledge” means first hand and actual
knowledge of the officers of PFIZER and is not meant to require or imply that any
particular inquiry or investigation has been undertaken including, without
limitation, obtaining any type of search (independent of that performed by the

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	 	 	 	actual governmental authority during the normal course of patent prosecution, as
applicable, in a jurisdiction) or opinion of counsel.

	 
	 	10.3.	 	Covenants and Representations and Warranties by LICENSEE. LICENSEE represents
warrants and covenants to PFIZER as of the Effective Date that:

	 	(a)	 	it shall, and shall ensure all Third Parties that it engages,
comply with all Applicable Law with respect to the performance of its
obligations hereunder.

	 
	 	(b)	 	Without limiting the generality of Section 10.3(a), LICENSEE
shall comply with the U.S. Foreign Corrupt Practices Act of 1977 (as modified
or amended). LICENSEE represents warrants and covenants that it has not and
will not directly or indirectly offer or pay, or authorize such offer or
payment of, any money, or transfer anything of value, to improperly seek to
influence any Government Official. If LICENSEE is itself a Government
Official, LICENSEE represents warrants and covenants that it has not accepted,
and will not accept in the future, such a payment or transfer. As used herein,
“Governmental Official” means: (a) any elected or appointed government official
(e.g., a member of a ministry of health), (b) any employee or person acting for
or on behalf of a government official, agency, or enterprise performing a
governmental function, (c) any political party officer, employee, or person
acting for or on behalf of a political party or candidate for public office,
(d) an employee or person acting for or on behalf of a public international
organization, or (e) any person otherwise categorized as a government official
under local law. “Government” is meant to include all levels and subdivisions
of non-U.S. governments (i.e., local, regional, or national and administrative,
legislative, or executive).

	 	10.4.	 	No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS SECTION 10, NEITHER
PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO WARRANTIES OF TITLE,
NON-INFRINGEMENT, VALIDITY, ENFORCEABILITY, MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE. ANY INFORMATION PROVIDED BY PFIZER OR ITS AFFILIATES IS MADE
AVAILABLE ON AN “AS IS” BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS, COMPLIANCE
WITH REGULATORY STANDARDS OR REGULATIONS OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED.

	11.	 	INDEMNIFICATION

	 	11.1.	 	Indemnification by LICENSEE. LICENSEE agrees to indemnify, hold harmless and
defend PFIZER and its Affiliates, and their respective officers, directors, employees,
contractors, agents and assigns (collectively, “PFIZER Indemnitees”), from and against
any Claims arising or resulting from: (a) the Development of a Product by LICENSEE, its
Affiliates, subcontractors or sublicensees, (b) the

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	 	 	 	Commercialization of a Product by LICENSEE, its Affiliates, subcontractors or
sublicensees, (c) the negligence, recklessness or wrongful intentional acts or
omissions of LICENSEE, its Affiliates, subcontractors or sublicensees, (d) breach by
LICENSEE of any representation, warranty or covenant as set forth in this Agreement
or (e) breach by LICENSEE of the scope of the license set forth in Section 2.1. As
used herein, “Claims” means collectively, any and all Third Party demands, claims,
actions and proceedings (whether criminal or civil, in contract, tort or otherwise)
for losses, damages, liabilities, costs and expenses (including reasonable
attorneys’ fees).

	 
	 	11.2.	 	Indemnification Procedure. In connection with any Claim for which PFIZER
seeks indemnification from LICENSEE pursuant to this Agreement, PFIZER shall: (a) give
LICENSEE prompt written notice of the Claim; provided, however, that failure to provide
such notice shall not relieve LICENSEE from its liability or obligation hereunder,
except to the extent of any material prejudice as a direct result of such failure; (b)
cooperate with LICENSEE, at LICENSEE’s expense, in connection with the defense and
settlement of the Claim; and (c) permit LICENSEE to control the defense and settlement
of the Claim; provided, however, that LICENSEE may not settle the Claim without
PFIZER’s prior written consent, which shall not be unreasonably withheld or delayed, in
the event such settlement materially adversely impacts PFIZER’s rights or obligations.
Further, PFIZER shall have the right to participate (but not control) and be
represented in any suit or action by advisory counsel of its selection and at its own
expense.

	12.	 	LIMITATION OF LIABILITY

	 	12.1.	 	Consequential Damages Waiver. EXCEPT FOR A BREACH OF SECTION 9 OR OBLIGATIONS
ARISING UNDER SECTION 11, NEITHER PARTY SHALL BE LIABLE FOR ANY INDIRECT OR
CONSEQUENTIAL, DAMAGES, INCLUDING DAMAGES FOR LOST PROFITS OR LOST REVENUES REGARDLESS
OF WHETHER IT HAS BEEN INFORMED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES OR THE
TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING NEGLIGENCE).

	 	12.2.	 	Liability Cap. EXCEPT FOR PFIZER’S BREACH OF SECTION 9, IN NO EVENT SHALL
PFIZER’S LIABILITY FOR DAMAGES IN CONNECTION WITH THIS AGREEMENT EXCEED THE CAP,
REGARDLESS OF WHETHER PFIZER HAS BEEN INFORMED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH
DAMAGES OR THE TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING NEGLIGENCE). “Cap” means ***
Dollars ($***).

	13.	 	TERM; TERMINATION

	 	13.1.	 	Term. The term of this Agreement shall commence as of the Effective Date and
shall expire upon the last-to-expire Patent Right in every country within the Territory
or ten (10) years from the First Commercial Sale of the last Product to be introduced
in any country within the Territory, whichever is later.

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	 	13.2.	 	Termination for Cause. Each Party shall have the right, without prejudice to
any other remedies available to it at law or in equity, to terminate this Agreement in
the event the other Party breaches any of its material obligations hereunder and fails
to cure such breach within sixty (60) days of receiving notice thereof;
provided, however, if such breach is capable of being cured, but cannot
be cured within such sixty (60) day period, and the breaching Party initiates actions
to cure such breach within such period and thereafter diligently pursues such actions,
the breaching Party shall have such additional period as is reasonable to cure such
breach, but in no event will such additional period exceed sixty (60) days. Any
termination by a Party under this Section 13.2 shall be without prejudice to any
damages or other legal or equitable remedies to which it may be entitled from the other
Party. For the avoidance of doubt, LICENSEE’s failure to use Commercially Reasonable
Efforts to Develop and Commercialize the Product shall constitute a material breach by
LICENSEE under this Agreement.

	 	13.3.	 	Termination by LICENSEE. LICENSEE will have the right to terminate this
Agreement in full ninety (90) days after delivery of written notice to PFIZER if the
Board of Directors of LICENSEE concludes due to scientific, technical, regulatory or
commercial reasons, including (i) safety or efficacy concerns, including adverse events
of the Product, (ii) concerns relating to the present or future marketability or
profitability of the Product, (iii) reasons related to Patent coverage or (iv) existing
and anticipated competition, renders the Development of the Product or the
Commercialization of the Product no longer commercially practicable for LICENSEE.
Notwithstanding the foregoing, LICENSEE shall not have the right to terminate the
Agreement under this Section 13.3 prior to the completion of the trial activities
specified in Section 4.1.2 other than for reasons of safety or efficacy as specified in
the protocols for such trial activities.

	 	13.4.	 	Termination for a Bankruptcy Event. Each Party shall have the right to
terminate this Agreement in the event of a Bankruptcy Event with respect to the other
Party. “Bankruptcy Event” means the occurrence of any of the following: (a) the
institution of any bankruptcy, receivership, insolvency, reorganization or other
similar proceedings by or against a Party under any bankruptcy, insolvency, or other
similar law now or hereinafter in effect, including any section or chapter of the
United States Bankruptcy Code, as amended or under any similar laws or statutes of the
United States or any state thereof (the “Bankruptcy Code”), where in the case of
involuntary proceedings such proceedings have not been dismissed or discharged within
ninety (90) days after they are instituted, (b) the insolvency or making of an
assignment for the benefit of creditors or the admittance by a Party of any involuntary
debts as they mature, (c) the institution of any reorganization, arrangement or other
readjustment of debt plan of a Party not involving the Bankruptcy Code, (d) appointment
of a receiver for all or substantially all of a Party’s assets, or (e) any corporate
action taken by the board of directors of a Party in furtherance of any of the
foregoing actions.

	 	13.5.	 	Effect of Termination or Expiration.

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	 	 	 	13.5.1. Upon termination or expiration of this Agreement, LICENSEE shall pay to
PFIZER all amounts due to PFIZER as of the effective date of termination or
expiration within thirty (30) days following the effective date of termination or
expiration.

	 
	 	 	 	13.5.2. Upon expiration of this Agreement, PFIZER hereby grants to LICENSEE a
royalty-free right and license to use the Know-How for the purpose of the
Development and Commercialization of the Product in the Field within the Territory.

	 
	 	 	 	13.5.3. Subject to Section 13.5.5(d), upon termination of this Agreement, LICENSEE
shall have the right to sell its remaining inventory of Product following the
termination of this Agreement so long as LICENSEE has fully paid, and continues to
fully pay when due, any and all Royalties and Milestone Payments owed to PFIZER,
and LICENSEE otherwise is not in material breach of this Agreement.

	 
	 	 	 	13.5.4. A termination of this Agreement, other than a termination under Section
13.3, will not automatically terminate any sublicense granted by LICENSEE pursuant
to Section 2.2 with respect to a non-Affiliated sublicensee, provided that (i) such
sublicensee is not then in breach of any provision of this Agreement or the
applicable sublicense agreement, (ii) PFIZER will have the right to step into the
role of LICENSEE as sublicensor, with all the rights that LICENSEE had under such
sublicense prior to termination of this Agreement (including the right to receive
any payments to LICENSEE by such Sublicensee that accrue from and after the date of
the termination of this Agreement) and (iii) PFIZER will only have those
obligations to such Sublicensee as PFIZER had to LICENSEE hereunder. LICENSEE
shall include in any sublicense agreement a provision in which said sublicensee
acknowledges its obligations to PFIZER hereunder and the rights of PFIZER to
terminate this Agreement with respect to any sublicensee for material breaches of
this Agreement by such sublicensee. The failure of LICENSEE to include in a
sublicense agreement the provision referenced in the immediately preceding sentence
will render the affected sublicense void ab initio.

	 
	 	 	 	13.5.5. With the exception of termination of this Agreement by LICENSEE pursuant to
Section 13.2, upon termination of this Agreement:

	 	(a)	 	LICENSEE hereby grants to PFIZER a non-exclusive, fully
paid-up, royalty-free, worldwide, transferable, perpetual and irrevocable
license, with the right to sublicense, to Use any and all Developed IP for Use
of the Product.

	 
	 	(b)	 	To the extent permitted by applicable Regulatory Authorities,
LICENSEE shall: (i) transfer to PFIZER all Regulatory Filings and Regulatory
Approvals held by LICENSEE with respect to the Product, and (ii) to the extent
subsection (i) is not permitted by the applicable Regulatory Authority, permit
PFIZER to cross-reference and rely upon any Regulatory Approvals and Regulatory
Filings filed by LICENSEE with respect to the Product.

- 27 -

 

	 	(c)	 	LICENSEE, if requested in writing by PFIZER, shall provide any
and all (i) material correspondence with the relevant patent offices pertaining
to the LICENSEE’s prosecution of the Patent Rights to the extent not previously
provided to PFIZER during the course of the Agreement and (ii) a report
detailing the status of all Patent Rights at the time of termination or
expiration.

	 
	 	(d)	 	Effective as of the date of termination, LICENSEE hereby grants
to PFIZER a fully paid-up, royalty-free, worldwide, transferable,
sublicensable, perpetual and irrevocable license to use the Trademarks
identifying a Product for the purpose of manufacturing, marketing, distributing
and selling the Product. As used herein, “Trademarks” means all registered and
unregistered trademarks, service marks, trade dress, trade names, logos,
insignias, domain names, symbols, designs, and combinations thereof.

	 
	 	(e)	 	LICENSEE will responsibly wind-down, in accordance with
accepted pharmaceutical industry norms and ethical practices, any on-going
clinical studies for which it has responsibility hereunder in which patient
dosing has commenced or, if reasonably practicable and requested by PFIZER,
allow PFIZER or its CRO to complete such trials (and then assign all related
Regulatory Documentation and investigator and other agreements relating to such
studies). LICENSEE shall be responsible for any Development costs associated
with such wind-down. PFIZER shall pay all Development Costs incurred by either
Party to complete such studies should PFIZER request that such studies be
completed. During any such winding down of ongoing trials, LICENSEE shall
provide such knowledge transfer and other training to PFIZER or its Affiliates
or a Third Party that is designated in writing by PFIZER (“Designated
Affiliate/Third Party”) as reasonably necessary for PFIZER or the Designated
Affiliate/Third Party to continue such trial. In connection with such
transfer, LICENSEE shall, at PFIZER’s option: (i) transfer to PFIZER or the
Designated Affiliate/Third Party all Product at the cost paid by LICENSEE to
manufacture such Product, (ii) transfer to PFIZER or the Designated
Affiliate/Third Party all LICENSEE Inventory owned by LICENSEE at the cost paid
by LICENSEE for such LICENSEE Inventory, and (iii) assign to PFIZER or the
Designated Affiliate/Third Party any agreements with Third Parties with respect
to the Development or Commercialization of the Product. As used herein,
“LICENSEE Inventory” means all components and works in process produced or held
by LICENSEE with respect to the manufacture of Products.

	 	13.6.	 	Survival. Expiration or termination of this Agreement shall not relieve the
Parties of any obligation accruing hereunder prior to such expiration or termination.
Without limiting the foregoing, the provisions of Sections 6, 7.1, 9, 11, 12, 13.5, 15,
16, 17.3 and 17.8 shall survive expiration or termination of this Agreement.

	14.	 	PUBLICITY AND PUBLICATIONS

	 	14.1.	 	Publicity and Publications.

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	 	 	 	14.1.1. Subject to PFIZER’s rights pursuant to Section 13.5.5(d), neither Party
(nor any of its Affiliates or agents) shall use the Trademarks of the other Party
or its Affiliates in any press release, publication or other form of promotional
disclosure without the prior written consent of the other Party in each instance.

	 
	 	 	 	14.1.2. Each Party agrees not to issue any press release or other public statement,
whether written, electronic, oral or otherwise, disclosing the existence of this
Agreement, the terms hereof or any information relating to this Agreement without
the prior written consent of the other Party, provided however,
that neither Party will be prevented from complying with any duty of disclosure it
may have pursuant to Applicable Law or the rules of any recognized stock exchange
so long as the disclosing Party provides the other Party at least ten (10) Business
Days prior written notice to the extent practicable and only discloses information
to the extent required by Applicable Law or the rules of any recognized stock
exchange.

	 
	 	 	 	14.1.3. LICENSEE acknowledges that PFIZER personnel may desire to publish in
scientific journals or present at scientific conferences scientific, pre-clinical
or clinical data derived from research and development related to the Compound that
was conducted by PFIZER prior to the Effective Date. Both Parties understand that
a reasonable commercial strategy may require delay of publication of information,
filing of patent applications, or, in some instances, disapproval of publication
altogether. Accordingly, no such publication will be submitted and no such
presentation shall be made without the prior written consent of LICENSEE, in its
sole discretion. Any such publication or presentation shall be submitted in
writing to LICENSEE for review by LICENSEE’s management. After receipt of the
proposed publication by LICENSEE’s management’s, such written approval or
disapproval will be provided within thirty (30) days

	 
	 	 	 	14.1.4. To the extent inventions are disclosed (or proposed to be disclosed) that
relate to the Compound in such publications, as to which PFIZER has not, prior to
the Effective Date, yet made patent filings, any patent applications filed
following the Effective Date at the discretion of either LICENSEE or PFIZER in
respect of such inventions, and any patents that issue therefrom shall be deemed to
be Patent Rights for all purposes of this Agreement.

	15.	 	LICENSEE INSURANCE

	 	15.1.	 	Insurance Requirements. LICENSEE shall maintain during the term of this
Agreement and until the later of: (a) three (3) years after termination or expiration
of this Agreement, or (b) the date that all statutes of limitation covering claims or
suits that may be instituted for personal injury based on the sale or use of the
Product have expired, commercial general liability insurance from a minimum “A-” AM
Bests rated insurance company or insurer reasonably acceptable to PFIZER, including
contractual liability and product liability or clinical trials, if applicable, with
coverage limits of not less than *** (***) million US dollars per occurrence and ***
(***) million US dollars in the aggregate. LICENSEE has the right to provide the total
limits required by any combination of primary and umbrella/excess coverage. The
minimum level of insurance set forth herein shall not be construed to create a limit

- 29 -

 

	 	 	 	on LICENSEE’s liability hereunder. Such policies shall name PFIZER and its
Affiliates as additional insured and provide a waiver of subrogation in favor of
PFIZER and its Affiliates. Such insurance policies shall be primary and
non-contributing with respect to any other similar insurance policies available to
PFIZER or its Affiliates. Any deductibles for such insurance shall be assumed by
LICENSEE.

	 
	 	15.2.	 	Policy Notification. LICENSEE shall provide PFIZER with original certificates
of insurance (which may be done through the submission of an electronic copy of such
certificate) evidencing such insurance: (a) promptly following execution by both
Parties of this Agreement, and (b) prior to expiration of any one coverage. PFIZER
shall be given at least thirty (30) days written notice prior to cancellation,
termination or any change to restrict the coverage or reduce the limits afforded.

	16.	 	DISPUTE RESOLUTION

	 	16.1.	 	General. Except for disputes for which injunctive or other equitable relief
is sought to prevent the unauthorized use or disclosure of proprietary materials or
information or prevent the infringement or misappropriation of a Party’s Intellectual
Property Rights, the following procedures shall be used to resolve all disputes arising
out of or in connection with this Agreement.

	 
	 	16.2.	 	Dispute Escalation. Promptly after the written request of either Party, each
of the Parties shall appoint a designated representative to meet in person or by
telephone to attempt in good faith to resolve any dispute. If the designated
representatives do not resolve the dispute within fifteen (15) Business Days of such
request, then an executive officer of each Party shall meet in person or by telephone
to review and attempt to resolve the dispute in good faith. The executive officers
shall have twenty (20) Business Days to attempt to resolve the dispute.

	 
	 	16.3.	 	Arbitration.

	 
	 	 	 	16.3.1. Full Arbitration. Unless Section 16.3.2 is applicable, in the event the
Parties are not able to resolve such dispute through the dispute escalation
procedure described above, either Party may at any time after such 20 Business Day
period submit such dispute to be finally settled by arbitration administered in
accordance with the rules of Judicial Administration and Arbitration Services
(“JAMS”) in effect at the time of submission, as modified by this Section 16. The
arbitration will be heard and determined by three (3) arbitrators who are retired
judges or attorneys with at least ten (10) years of experience with intellectual
property license agreements in the pharmaceutical or biotechnology industry, each
of whom will be a neutral as to both Parties. Each Party will appoint one
arbitrator and the third arbitrator will be selected by the two Party-appointed
arbitrators, or, failing agreement within thirty (30) days following the date of
receipt by the respondent of the claim, by JAMS. Such arbitration will take place
in New York, NY. The arbitration award so given will be a final and binding
determination of the dispute, will be fully enforceable in any court of competent
jurisdiction, and will not include any damages expressly prohibited by Section 12.
Fees, costs and expenses of arbitration are to be divided by the Parties in the
following manner: LICENSEE

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	 	 	 	will pay for the arbitrator it chooses, PFIZER will pay for the arbitrator it
chooses, and the Parties will share payment for the third arbitrator. Except in a
proceeding to enforce the results of the arbitration or as otherwise required by
law, neither Party nor any arbitrator may disclose the existence, content or
results of any arbitration hereunder without the prior written agreement of both
Parties.

	 
	 	 	 	16.3.2. Accelerated Arbitration. To the extent the arbitration matter involves a
dispute that is submitted to arbitration by a Party under Section 6.1.4 or any
dispute regarding the proper characterization of a dispute subject to resolution
under this Section 16.3.2 as opposed to Section 16.3.1, the following procedures
will also apply:

	 	(a)	 	For purposes of arbitration under this Section 16.3.2, the
arbitrator will be appointed pursuant to Section 16.3.1, but will be a single
independent, conflict-free arbitrator with the requisite licensing and
pharmaceutical industry experience (such arbitrator, the “Expert”). The
Parties may select a different Expert for each dispute depending on the nature
of the issues presented and desired expertise.

	 
	 	(b)	 	Each Party will prepare and submit a written summary of such
Party’s position and any relevant evidence in support thereof to the Expert
within thirty (30) days of the selection of the Expert. Upon receipt of such
summaries from both Parties, the Expert will provide copies of the same to the
other Party. The Expert will be authorized to solicit briefing or other
submissions on particular questions. Within fifteen (15) days of the delivery
of such summaries by the Expert, each Party will submit a written rebuttal of
the other Party’s summary and may also amend and re-submit its original
summary. Oral presentations will not be permitted unless otherwise requested
by the Expert. The Expert will make a final decision with respect to the
arbitration matter within thirty (30) days following receipt of the last of
such rebuttal statements submitted by the Parties and will make a determination
by selecting the resolution proposed by one of the Parties that as a whole is
the most fair and reasonable to the Parties in light of the totality of the
circumstances and will provide the Parties with a written statement setting
forth the basis of the determination in connection therewith. For purposes of
clarity, the Expert will only have the right to select a resolution proposed by
one of the Parties in its entirety and without modification.

	 
	 	(c)	 	The Parties further agree that the decision of the Expert will
be the sole, exclusive and binding remedy between them regarding determination
of the arbitration matter so presented. Confirmation of, or judgment upon any
award rendered pursuant to this Section 16.3.2 may be entered by any court of
competent jurisdiction. The Expert will have no authority to award any type of
damages excluded under Section 12.

	 	 	 	16.3.3. Injunctive Relief. Notwithstanding the dispute resolution procedures set
forth in this Section 16, in the event of an actual or threatened breach hereunder,
the aggrieved Party may seek equitable relief (including restraining orders,
specific

 

- 31 -

 

	 	 	 	performance or other injunctive relief) in any court or other forum, without first
submitting to any dispute resolution procedures hereunder.

	 
	 	 	 	16.3.4. Tolling. The Parties agree that all applicable statutes of limitation and
time-based defenses (such as estoppel and laches) will be tolled while the dispute
resolution procedures set forth in this Section 16 are pending, and the Parties
will cooperate in taking all actions reasonably necessary to achieve such a result.
In addition, during the pendency of any arbitration under this Agreement initiated
before the end of any applicable cure period under Section 13.2, (i) this Agreement
will remain in full force and effect, (ii) the provisions of this Agreement
relating to termination for material breach will not be effective, (iii) the time
periods for cure under Section 13 as to any termination notice given prior to the
initiation of arbitration will be tolled, and (iv) neither Party will issue a
notice of termination pursuant to such sections, until the arbitral tribunal has
confirmed the existence of the facts claimed by a Party to be the basis for the
asserted material breach.

	17.	 	GENERAL PROVISIONS

	 	17.1.	 	Assignment

	 
	 	 	 	17.1.1. Neither Party may assign its rights and obligations under this Agreement
without the other Party’s prior written consent, except that: (a) PFIZER may assign
to a Third Party its rights to receive some or all of the Fees payable hereunder,
(b) each Party may assign its rights and obligations under this Agreement to one or
more of its Affiliates without the consent of the other Party and (c) either Party
may assign this Agreement in the event of a Change in Control. As used herein,
“Change in Control” means the acquisition of a party by a Third Party or the sale
of all or substantially all of its business to which this Agreement relates. The
assigning Party shall provide the other Party with prompt written notice of any
such assignment. Any permitted assignee pursuant to clauses (b) and (c) above
shall assume all obligations of its assignor under this Agreement, and no permitted
assignment shall relieve the assignor of liability for its obligations hereunder.
Any attempted assignment in contravention of the foregoing shall be void. As used
herein, “Fees” means collectively, any and all Milestone Payments and Royalties.

	 
	 	 	 	17.1.2. Prior to any proposed assignment by the LICENSEE of any of the Licensed
Technology PFIZER shall have a right of first negotiation as more fully
particularized in Section 2.6.

	 
	 	17.2.	 	Severability. Should one or more of the provisions of this Agreement become
void or unenforceable as a matter of law, then such provision will be ineffective only
to the extent of such prohibition or invalidity, without invalidating the remainder of
this Agreement, and the Parties agree to substitute a valid and enforceable provision
therefor which, as nearly as possible, achieves the desired economic effect and mutual
understanding of the Parties under this Agreement.

	 
	 	17.3.	 	Governing Law; Exclusive Jurisdiction.

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	 	 	 	17.3.1. This Agreement shall be governed by and construed under the laws in effect
in the State of New York, US, without giving effect to any conflicts of laws
provision thereof or of any other jurisdiction that would produce a contrary
result, except that issues subject to the arbitration clause and any arbitration
hereunder shall be governed by the applicable commercial arbitration rules and
regulations.

	 
	 	 	 	17.3.2. The courts of New York shall have exclusive jurisdiction over any action
for injunctive relief contemplated by Section 16.1 or for the enforcement of any
arbitral award resulting from arbitrations brought in accordance with Section 16,
and each of the Parties hereto irrevocably: (a) submits to such exclusive
jurisdiction for such purpose; (b) waives any objection which it may have at any
time to the laying of venue of any proceedings brought in such courts; (c) waives
any claim that such proceedings have been brought in an inconvenient forum, and (d)
further waives the right to object with respect to such proceedings that any such
court does not have jurisdiction over such Party. Notwithstanding the foregoing,
application may be made to any court of competent jurisdiction with respect to the
enforcement of any judgment or award.

	 
	 	17.4.	 	Force Majeure. Except with respect to delays or nonperformance caused by the
negligent or intentional act or omission of a Party, any delay or nonperformance by
such Party (other than payment obligations under this Agreement) will not be considered
a breach of this Agreement to the extent such delay or nonperformance is caused by acts
of God, natural disasters, acts of the government or civil or military authority, fire,
floods, epidemics, quarantine, energy crises, war or riots or other similar cause
outside of the reasonable control of such Party (each, a “Force Majeure Event”),
provided that the Party affected by such Force Majeure Event will promptly begin
or resume performance as soon as reasonably practicable after the event has abated. If
the Force Majeure Event prevents a Party from performing any of its obligations under
this Agreement for one hundred eighty (180) days or more, then the other Party may
terminate this Agreement immediately upon written notice to the non-performing Party.

	 
	 	17.5.	 	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. No waiver shall be effective unless it has
been given in writing and signed by the Party giving such waiver. No provision of this
Agreement may be amended or modified other than by a written document signed by
authorized representatives of each Party.

	 
	 	17.6.	 	Relationship of the Parties. Nothing contained in this Agreement shall be
deemed to constitute a partnership, joint venture, or legal entity of any type between
PFIZER and LICENSEE, or to constitute one Party as the agent of the other. Moreover,
each Party agrees not to construe this Agreement, or any of the transactions
contemplated hereby, as a partnership for any tax purposes. Each Party shall act
solely as an independent contractor, and nothing in this Agreement shall be construed
to give any Party the power or authority to act for, bind, or commit the other Party.

- 33 -

 

	 	17.7.	 	Successors and Assigns. This Agreement shall be binding upon and inure to the
benefit of the Parties hereto and their respective successors and permitted assigns.

	 
	 	17.8.	 	Notices. All notices, consents, waivers, and other communications under this
Agreement must be in writing and will be deemed to have been duly given when: (a)
delivered by hand (with written confirmation of receipt), (b) sent by fax (with written
confirmation of receipt), provided that a copy is sent by an internationally recognized
overnight delivery service (receipt requested), or (c) when received by the addressee,
if sent by an internationally recognized overnight delivery service (receipt
requested), in each case to the appropriate addresses and fax numbers set forth below
(or to such other addresses and fax numbers as a Party may designate by written
notice):

If to PFIZER:

PFIZER INC.

235 East 42nd Street

New York, NY 10017

Fax: 646-348-8157

Attention: General Counsel

If to LICENSEE:

CLOVIS ONCOLOGY, INC.

2525 28th Street, Suite 180

Boulder, CO 80301

Fax: (303) 245-0361

Attention: Chief Executive Officer

	 	17.9.	 	Further Assurances. LICENSEE and PFIZER hereby covenant and agree without the
necessity of any further consideration, to execute, acknowledge and deliver any and all
such other documents and take any such other action as may be reasonably necessary or
appropriate to carry out the intent and purposes of this Agreement.

	 
	 	17.10.	 	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, without
limitation, any third party beneficiary rights) with respect to or in connection with
any agreement or provision contained herein or contemplated hereby.

	 
	 	17.11.	 	Entire Agreement; Confidentiality Agreement.

	 	(a)	 	This Agreement, together with its Schedules, sets forth the
entire agreement and understanding of the Parties as to the subject matter
hereof and supersedes all proposals, oral or written, and all other prior
communications between the Parties with respect to such subject matter,
including, without limitation, that certain Confidentiality Agreement by and
between the Parties, 

- 34 -

 

	 	 	 	dated April 18, 2011 (“CDA”). The Parties acknowledge
and agree that, as of the Effective Date, all Evaluation Material (as defined in the CDA)
disclosed by PFIZER or its Affiliates pursuant to the CDA shall be
considered PFIZER’s Confidential Information and subject to the terms set
forth in this Agreement.

	 
	 	(b)	 	In the event of any conflict between a material provision of
this Agreement and any Schedule hereto, the Agreement shall control.

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

	 
	 	17.13.	 	Cumulative Remedies. No remedy referred to in this Agreement is intended to be
exclusive, but each shall be cumulative and in addition to any other remedy referred to
in this Agreement or otherwise available under law.

	 
	 	17.14.	 	Waiver of Rule of Construction. Each Party has had the opportunity to consult with
counsel in connection with the review, drafting and negotiation of this Agreement.
Accordingly, any rule of construction that any ambiguity in this Agreement shall be
construed against the drafting Party shall not apply.

	 
	 	17.15.	 	Construction. For purposes of this Agreement: (a) words in the singular shall be held
to include the plural and vice versa as the context requires; (b) the words “including”
and “include” shall mean “including, without limitation,” unless otherwise specified;
(c) the terms “hereof,” “herein,” “herewith,” and “hereunder,” and words of similar
import shall, unless otherwise stated, be construed to refer to this Agreement as a
whole and not to any particular provision of this Agreement; and (d) all references to
“Section”, “Schedule” and “Exhibit,” unless otherwise specified, are intended to refer
to a Section, Schedule or Exhibit of or to this Agreement.

[Signatures on next page]

- 35 -

 

          IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be
executed by their duly authorized representatives as of the Effective Date.

	 	 	 

	PFIZER INC.

	 	CLOVIS ONCOLOGY INC.
	 
	 	 
	By: /s/ GARRY NICHOLSON

	 	By:/s/ PATRICK J. MAHAFFY
	 
	 	 
	Name:  Garry Nicholson

	 	Name: Patrick J. Mahaffy
	 
	 	 
	Title: President, General Manager

	 	Title: President and CEO

- 36 -

 

     

SCHEDULE A – PATENT RIGHTS

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Pfizer

Ref. No.	 	 	Country	 	 	 	Application Number	 	 	 	Application

Date	 	 	 	Patent Number	 	 	 	Grant Date	 	 	 	Expiration Date	 	 	 	Status	 

***

1

 

SCHEDULE B - TECHNICAL TRANSFER TRANSITION PLAN

THIS TECHNICAL TRANSFER PLAN (“PLAN”) IS ENTERED INTO AS OF THE EFFECTIVE DATE BY AND BETWEEN
(I) LICENSEE AND (II) PFIZER ALL CAPITALIZED TERMS USED HEREIN AND NOT OTHERWISE DEFINED SHALL
HAVE THE MEANING SET OUT IN THE AGREEMENT.

The Parties agree as follows with respect to the Compound and Licensed Technology and Regulatory
Filings:

	 	1.	 	Transitional Services

	 	1.1	 	Transition Plan/Hours Cap/Additional Consulting Services

	 	1.1.1	 	Detailed Transition Plan. As soon as reasonably
possible after the Effective Date, the Transition Coordinators will work
together in good faith to agree upon a transition plan which will identify,
among other elements, joint functional area kick-off meetings and regular
meetings during the Initial Transition Period (as defined below), as
appropriate, to ensure transfer of project knowledge, to establish
communication plans with external collaborators and vendors such that
LICENSEE will begin to be included in ongoing activities and communications
as soon as possible following the Effective Date, and to prioritize the
transfer of documents and records, all within the framework of the following
Sections of this Schedule B. While the sections below set forth outside
completion dates for various tasks, both Parties shall use good faith efforts
to complete the various tasks earlier than such outside dates.

	 	1.1.2	 	PFIZER shall make available to LICENSEE certain expertise
for consultation with LICENSEE’s representatives via telephone or
correspondence for the purpose of conducting the following activities related
to the Transition Plan contemplated by this Schedule B: (a) conveying and
transferring information, (b) answering inquiries and (c) conducting research
for the purpose of responding to such inquiries (the activities pursuant to
these activities shall be collectively referred to as the “Consulting
Services”). LICENSEE shall reimburse PFIZER for any travel expenses incurred
by PFIZER if PFIZER representatives travel to LICENSEE site(s) or other
non-PFIZER locations, and time devoted to such travel and Consultation
Services at such locations shall be either Consulting Services or Additional
Consulting Services in accordance with Section 1.

	 	1.1.3	 	PFIZER shall provide such Consulting Services upon
reasonable notice from LICENSEE to PFIZER and during PFIZER’s normal business
hours. Such Consulting Services shall be provided by PFIZER at no charge for
the first three (3) months after the Effective Date (the “Initial Transition
Period”) for all consultations. For the three (3) month period following the
Initial Transition Period, PFIZER shall provide Consulting Services at no
charge for up to *** hours (the “Hours Cap”). The calculation of the Hours
Cap shall include the number of hours expended by PFIZER in answering
inquiries from LICENSEE related to Transition Plan, but shall not include the
hours of effort incurred by transferring to LICENSEE the Documentation of the
Included Assets. All hours of Consultation beyond *** hours shall be
considered “Additional Consulting Services”.

 

 

	 	1.1.4	 	Any time devoted by PFIZER personnel on preparation or
review of publications (either sole PFIZER, joint PFIZER with external
collaborators or joint PFIZER and LICENSEE) of research results will not be
considered as Consulting Services and will not count against the Hours Cap.

	 	1.1.5	 	Fees for any Additional Consulting Services shall include:

	 	1.1.5.1	 	Any out-of-pocket travel and hotel costs and expenses incurred by
PFIZER representatives in performing the Consulting Services.

	 	1.1.5.2	 	All hours of Consultation beyond *** hours shall be charged at a
rate of $*** per hour.

	 	1.2	 	Document, Information, and Material Transfer

	 	1.2.1	 	Initial Request. No later than *** months
after the Effective Date (unless otherwise specified herein or agreed to in
writing by the Parties), PFIZER shall provide to LICENSEE all Licensed
Technology to the extent it exists as of the Effective Date; provided that
PFIZER has the right, but not the obligation to retain (a) copies of all such
documents and records, (b) copies of Regulatory Filings and correspondence,
and clinical trial data, and (c) any records reasonably required by PFIZER
for the conduct of its activities under the terms of its previous
obligations.

	 	1.2.2	 	Records to be transferred: Notwithstanding the
foregoing, the Parties agree as follows with respect to the Licensed
Technology (“Included Assets”): (i) no later than *** Business Days
after the Effective Date PFIZER shall provide electronic copies (in
Microsoft Office format and/or in other non-proprietary format) of relevant
documents, information, records, and data (“Documentation”), by a method
reasonably acceptable to LICENSEE. To the extent such Documentation exists
as of the Effective Date in an electronic format, including scanned versions
of a hardcopy, PFIZER shall provide to LICENSEE only an electronic copy of
such Documentation. For Documentation which does not exist in an electronic
format as of the Effective Date, PFIZER shall provide to LICENSEE a physical
copy of the Documentation. Notwithstanding the foregoing, in no event shall
PFIZER be required to provide: (i) data or records that include technology
or products other than those that relate to the Included Assets or (ii)
laboratory notebooks, personal notes of PFIZER employees or any of PFIZER’s
contractors or subcontractors, or internal intra-PFIZER correspondence;
provided, however, PFIZER shall provide to LICENSEE summary information that
pertains to the Included Assets to the extent such summary information: (x)
exists as of the Effective Date; (y) is retained by or on behalf of PFIZER;
and (z) is reasonably retrievable by PFIZER.

	 	1.3	 	Transfer of Specimens; Inventory

	 	1.3.1	 	GLP Studies: Within *** Business Days of the
Effective Date, PFIZER shall identify and produce specimens/data records
that were identified in final reports of GLP studies as having been archived
at or by PFIZER. Such Items will be shipped within thirty (30) Business
Days following PFIZER’s receipt of notice from LICENSEE to an archival
facility of LICENSEE choice at

 

 

	 	 	 	LICENSEE expense and direction. This facility must be identified within
*** months of the Effective Date. LICENSEE shall bear all costs and
expenses incurred by PFIZER after the Effective Date related to packaging
and shipping the Items pursuant to this Section.

	 	1.3.2	 	Items to be Transferred: For Items in the possession of
a Third Party, LICENSEE shall coordinate with such Third Party to transfer
the Items, including, without limitation, transfer of the GMP protocols,
receiving documentation, insurance requirements and temperature monitors.
For Items in the possession of PFIZER, PFIZER shall package and ship such
Items within thirty (30) Business Days following PFIZER’s receipt of notice
from LICENSEE. This shipping notification must take place within the first
*** months after the Effective Date to allow sufficient time to
accomplish the transfer before the *** month transition period
completes. LICENSEE shall bear all costs and expenses incurred by PFIZER
after the Effective Date related to packaging and shipping the Items
pursuant to this Section.

	 	1.4	 	Regulatory Applications

	 	1.4.1	 	United States INDs. Within *** Business
Days after written notification from LICENSEE that LICENSEE is able to
assume all clinical, regulatory, and safety obligations, PFIZER shall execute
all documents (in a form reasonably acceptable to LICENSEE) required to
transfer the sponsorship of all United States INDs for the Compound to
LICENSEE This transfer notification must take place within the first *** months after the Effective Date to allow for sufficient time to
accomplish the full IND transfer before the *** month transition period
completes.

	 	1.4.2	 	Maintenance of IND. For the period beginning on
the Effective Date and ending on the effective date of the transfer of the
applicable IND (i.e., the date that the LICENSEE serves official
confirmation of acceptance of Regulatory transfer of responsibility) PFIZER
shall continue to maintain the relevant INDs for the Compound, at LICENSEE’s
direction and expense.

	 	1.4.3	 	Electronic Versions of Documents. Within *** Business Days after the Effective Date, PFIZER shall deliver electronic
files of the sections of all open INDs for the Compound, and any subsequent
updates thereto. For Regulatory filings other than INDs, PFIZER shall
deliver electronic versions of these filings within *** Business Days
of the Effective Date.

	 	1.4.4	 	Other Regulatory Filings. Where appropriate,
within thirty (30) Business Days after written notification from LICENSEE
that LICENSEE is able to assume all clinical, regulatory, and safety
obligations, PFIZER shall execute all documents (in a form reasonably
acceptable to LICENSEE) required to transfer the sponsorship of all other
Regulatory filings for the Compound to LICENSEE. This transfer notification
must take place within the first *** months after the Effective Date to
allow for sufficient time to accomplish the full IND transfer before the *** month transition period completes.

	 	1.4.5	 	Trial Master Files. PFIZER shall forward Trial
Master Files (TMF’s) or equivalent, for all completed clinical studies for
the Compound (i.e, studies with signed-off final clinical study reports), to
LICENSEE, as promptly as practicable

 

 

	 	 	 	but in no event no later than sixty (60) calendar days after receipt of
such written request from LICENSEE. This transfer notification must take
place within the first *** months after the Effective Date to allow
for sufficient time to accomplish the full document transfer before the
*** month transition period completes. This transfer is subject to the
conditions in Section 1.1.3 above. For study A4991014, which is currently
ongoing, the trial master file will remain at PFIZER until thirty (30)
calendar days after operational control has been transitioned to LICENSEE.

	 	1.4.6	 	Interaction with Regulatory Authorities. For the
period beginning on the Effective Date and ending on the effective date of
the transfer of the applicable Regulatory Filing, LICENSEE shall
lead1 all interactions with any Regulatory Authority
relating to the Compound. Notwithstanding the foregoing, for the period
beginning after the Effective Date and ending on the effective date of the
transfer of the applicable Regulatory Filing in such country, if LICENSEE so
reasonably requests, PFIZER will participate, by telephone, in certain
interactions with Regulatory Authorities relating to the Compound, at
LICENSEE’s direction and expense, provided that LICENSEE shall provide PFIZER
written notice at least ten (10) Business Days prior to any such meetings.

	 	1.4.7	 	Ongoing Responsibilities. In connection with the
United States IND, an annual report is due in ***. The data
cut-off for this report is ***. In order to allow for a smooth
transitioning of responsibility regarding this report: (a) after the
Effective Date, PFIZER shall continue to run the clinical safety tables for
this report, at its cost; (b) LICENSEE shall take responsibility for drafting
such annual report and submitting it to the FDA, and (c) PFIZER shall provide
Consulting Services for input and review on such annual report as may be
requested by LICENSEE according to the agreement on Consulting Services
described in Section 1.1.3 of this Schedule B.

	 	1.5	 	Miscellaneous Carry-Over Activities

	 	1.5.1	 	*** 

	 	1.5.2	 	CRUK Resupply. From its existing inventory of
drug product, PFIZER shall complete its commitment to package and ship at
its cost to Cancer Research UK (“CRUK”) the requested resupply of Product
for the CRUK IIR Phase II trial.

	 	1.5.3	 	***

 

1            Clovis cannot lead interactions with
Regulatory Authorities until Pfizer submits the letter to change sponsorship
and the Authorities acknowledge receipt. Therefore, Pfizer will need to lead
the interactions until this occurs. Following that time, Clovis will lead.

 

 

	 	1.6	 	Safety Reporting

	 	1.6.1	 	Unless otherwise directed by LICENSEE, PFIZER shall
submit PFIZER-generated CIOMS/serious adverse event reports for all
Compounds, to the relevant Regulatory Authority for the period beginning on
the Effective Date and ending on the effective date of the transfer of the
applicable IND to LICENSEE.

	 	1.7	 	Pharmaceutical Sciences/Manufacturing

	 	1.7.1	 	Document Transfer and Management. PFIZER shall
disclose all Licensed Technology, including, summary reports, formulation
folders, data related to the pharmaceutical development of the Compounds, to
LICENSEE no later than *** Business Days after the Effective
Date.

	 	1.7.2	 	Inventory Transfer and Management. PFIZER shall
transfer all outstanding inventories of non-GMP and GMP API for the Compounds
to LICENSEE within *** Business Days after the Effective Date,
unless subject to a separate written supplies agreement. Such shipment will
occur following PFIZER’s receipt of notice from LICENSEE to a storage
facility of LICENSEE choice at LICENSEE expense and direction. LICENSEE
shall bear all costs and expenses incurred by PFIZER after the Effective Date
related to packaging and shipping the Items pursuant to this Section. After
the Effective Date, except as permitted under a separate Supplies Agreement,
or as required for the completion of this Transition Plan, PFIZER shall not
provide any Compound(s), whether API or finished drug product, to any Third
Party without the prior consent of LICENSEE. After the Effective Date,
PFIZER shall not provide any documents, information or data relating to
Compound to any Third Party without the prior consent of LICENSEE.

 

 

	 	1.7.2.1	 	Finished drug product identified as in Schedule E shall be
transferred to LICENSEE – within *** Business Days after the
Effective Date.

	 
	 	1.7.2.2	 	For so long as PFIZER maintains ongoing stability testing and
manufacture of API and finished drug product, it shall retain
manufacturing reference standards. Thereafter, the Parties will
cooperate to transfer portions of the remaining reference standards
to such contract manufacturing organizations as LICENSEE shall have
selected for its ongoing manufacturing needs.

	 
	 	1.7.2.3	 	On-going API and drug product clinical stability studies –
currently stability set-up and testing is taking place in Sandwich.
Within *** days of the Effective Date the LICENSEE will
identify a contract laboratory wherein which these stability programs
will be conducted. PFIZER will support the transition of these
studies to this new contract laboratory, including transfer of all
materials set-up on stability (at the cost of LICENSEE), reference
standards, analytical methods and data to date within a subsequent
*** day period.

	 
	 	1.7.2.4	 	Currently scheduled production is identified in Schedule E. It
will be sold by PFIZER to LICENSEE in the quantities, at the price
and with the delivery dates specified in Schedule E if requested by
LICENSEE. All such sales will be effected under a purchase order and
will otherwise be under standard PFIZER terms and conditions.

	 
	 	1.7.2.5	 	LICENSEE has requested future manufacture of additional 40/60 mg
tablets for ongoing Existing Trials, beyond what is currently in
inventory and beyond currently scheduled product, as set forth in
Schedule E. PFIZER shall manufacture and sell to LICENSEE such
future production in the quantities, at the price and with the
delivery dates specified in Schedule E if requested by LICENSEE. All
such sales will be effected under a purchase order and will otherwise
be under standard PFIZER terms and conditions.

	 
	 	1.7.2.6	 	Except as provided in Section 1.5.1 above, from and after the
Effective Date, API or DP supply for currently ongoing investigator
initiated research studies – requests for investigator initiated
research studies are to be provided by LICENSEE.

	 
	 	1.7.2.7	 	Packaging, labeling, expiry updates and inventory management for
Existing Trials will continue to be managed by PFIZER for a period of
*** days after the Effective Date. Following
this period, LICENSEE will assume responsibility for these
activities, unless otherwise specified in Schedule E.

	 	1.7.3	 	Compensation. LICENSEE shall reimburse PFIZER
for (i) all invoiced costs and expenses incurred after the Effective Date in
a manner consistent with the customary invoice practices of any ongoing or
agreed manufacturing or packing effort and all invoiced costs and expenses in
a manner consistent with the

 

 

	 	 	 	customary invoice practices for on-going formulation, materials management and stability.

	 	1.8	 	Intellectual Property.

	 	1.8.1	 	For *** days following the Effective Date, PFIZER
shall monitor the intellectual property within the Patent Rights definition
and promptly forward to LICENSEE (but not later than ten (10) Business Days
of receipt thereof by PFIZER) (a) all correspondence received by PFIZER from
the relevant patent offices with respect to such intellectual property, and
(b) a schedule of applicable extension and expiration dates. Other than the
foregoing responsibility, PFIZER shall have no obligations with respect to
prosecuting or maintaining the intellectual property, including, without
limitation, filing any assignments or applications for renewal with the
relevant government offices; excepting, however, PFIZER shall be obligated to
reasonably cooperate with any requests from LICENSEE pertaining to, or in
furtherance of, prosecuting or maintaining the Patent Rights and filing any
assignments related thereto.

	 	1.9	 	Third Party Contracts.

	 	1.9.1	 	Assigned Agreements. Any relevant Third Party
Contracts (whether identified in Schedule B-1 or otherwise) shall be dealt
with after the Effective Date by the Parties in such manner as they may
mutually agree consistent with the rights and obligations of the Parties
under the Agreement.

	 	1.9.1.1	 	PFIZER shall cooperate with LICENSEE and interface with Third
Parties to achieve assignment or termination of existing Third Party
Contracts as mutually agreed by the Parties and to ensure transition
of all clinical trials and research relating to Compound, and
transfer of all materials and specimens

	 
	 	1.9.1.2	 	To the extent any Third Party Contracts related to the API or
finished drug product of the Compound, or to clinical trials ongoing
for the Product are Master Service Agreements which include other
activities of PFIZER, such Master Service Agreements shall not be
assigned to LICENSEE. PFIZER shall, however, identify such Master
Service Agreements and the services covered thereby, in connection
with the documentation transfer contemplated by Section 1.1 above,
including the identity and contact information of the Third Party
that is a party to such Master Service Agreement.

	 	1.10	 	Subsequent Requests. LICENSEE may request other documents, information,
records or data that are Licensed Technology on an as-needed basis during the *** month
Transition Period but no later than one month prior to the expiration of the *** month
Transition Period to accomplish the full document transfer with the *** Transition
Period. All such LICENSEE requests made after the Transition Period will be allocated
against the Consulting Services specified in Section 1.1.3 above.

	 	2.	 	Records, documents, samples and data to be transferred to LICENSEE.

PFIZER shall transfer to LICENSEE records, documents, samples and data including, but not limited
to the following, where such records exist as of the Effective Date and are reasonably
retrievable:

 

 

	 	2.1	 	Pharmaceutical Product and Supplies.

	 	2.1.1	 	Existing physical material inventory held by PFIZER to
include Active Pharmaceutical Ingredient (API),( non-GMP and GMP) and
clinical supplies; unless otherwise subject to a Supplies Agreement.

	 	2.1.2	 	Schedule of inventory held external to PFIZER including
quantity, expiration date and location

	 	2.1.3	 	Records of Inventory and Supply.

	 	2.1.4	 	Records pertaining to synthesis, formulation and
manufacture of the Compound

	 	2.1.5	 	Summaries of GLP or GMP audits, copies of which shall be
transferred to LICENSEE.

	 	2.2	 	Intellectual Property (“IP”).

	 	2.2.1	 	A listing of all patents and patent applications
encompassed by the term Patent Rights, including U.S. and foreign
equivalents, with docket and status reports to be delivered to LICENSEE,
within ***  Business Days of the Effective Date.

	 	2.2.2	 	Copies of file wrappers for the PFIZER Product Patent
Rights will be Delivered to LICENSEE within ***  calendar days of the
Effective Date. Records will be provided electronically in non-proprietary
format.

	 	2.2.3	 	After entering into a Community of Interest Agreement,
Pfizer will provide copies of all written searches, prior art, and written
opinions of counsel related to the Patent Rights or Products.

	 	2.2.4	 	LICENSEE shall inform PFIZER in writing within *** Business Days of the Effective Date the names of the outside counsel and
foreign patent counsel selected to maintain and prosecute the Patent Rights.
Upon receipt of the names of the outside counsel and foreign patent counsel
PFIZER shall inform its outside patent counsel, and any annuity services,
that transfer of responsibility for Patent Rights to LICENSEE’s counsel is
permitted or that it has no objection to Pfizer’s outside patent counsel or
annuity services representing Licensee in the future if they wish to do so.
LICENSEE is responsible for all costs and expenses incurred for the Patent
Rights ***  days after the Effective Date.

	 	2.3	 	Research and Development.

	 	2.3.1	 	Pre-clinical: Copies of all protocols, data, results, and
reports related to pivotal (e.g., GLP) pre-clinical studies for the
Compound(s):

	 	2.3.1.1	 	Animal efficacy studies;

	 
	 	2.3.1.2	 	Animal safety and toxicity studies;

 

 

	 	2.3.1.3	 	Specimens/data records associated with final reports of GLP toxicology
studies

	 
	 	2.3.1.4	 	Studies and reports prepared in support of IND submission(s);

	 
	 	2.3.1.5	 	For pre-clinical studies performed prior to the IND preparatory phase,
results will be provided in summary documents for studies or portions of
non-GLP studies already completed, where no report was intended to be
generated.

	 	2.3.2	 	Clinical: Copies of all protocols and amendments, study
reports and results (including tables, figures and data) related to the
Compound(s).

                              2.3.2.1 Adverse event reports (e.g., Medwatch or equivalent forms) for any and all clinical
trials (either investigator-initiated or PFIZER-sponsored)

                              2.3.2.2 Copies of Case Report Forms (CRFs) or equivalent for all completed clinical
studies for the Compound(s) (i.e. studies with signed off final clinical study reports)

                              2.3.2.3 Copies of the clinical study databases for all completed clinical studies for the
Compound(s) (ie studies with signed off final clinical study reports)

                              2.3.2.4 Summaries of any internal GCP audits – to the extent they exist.

	 	2.3.3	 	Ongoing clinical studies: the Parties will collaborate to
identify and prioritize the transfer of the working study management files
for study A4991014 and such other documents and data related to
such study as may not have been specifically identified in this Schedule B
but the transfer of which nevertheless would facilitate a smooth transition
of such trial. In addition, the Parties will meet during the first *** months following the Effective Date at the request of either Transition
Coordinator, to discuss such other exchanges of information or steps as shall
ensure a smooth transition of such trial.

	 	2.4	 	Regulatory.

	 	2.4.1	 	Filings, correspondence, and teleconference and meeting
minutes by Regulatory Agencies and PFIZER or its subsidiaries with any
federal, state, local or foreign governmental agency since inception (in this
regard, all filings and correspondence with the FDA, or any other national
regulatory agency).

	 	2.4.2	 	Copies of all Trial Master Files (TMF’s) equivalent, for
all completed clinical studies for the Compound(s) (i.e, studies with
signed-off final clinical study reports and to include but not limited to
copies of all clinical trial protocols and amendments, IRB/EC approvals,
forms 1572, informed consent forms, financial disclosure forms, Investigator
Brochures, related to the Compounds).

 

 

SCHEDULE B-1 – EXISTING TRIALS

	

	***
	

	

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title	 	 	Project Status	 	 	 	Country	 	 	 	Tracking Number	 	 	 	Contract. Org.	 	 	 	Investigator

Names	 	 	 	Study Type	 	 	 	Cancer Types	 	 	 	Grant Requests	 	 	 	Funding

Requested	 	 	 	2011 Payable	 	 	 	2012 and

Beyond	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	

	 
	

	***

	

	 
	

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title	 	 	Project Status	 	 	 	Country	 	 	 	Tracking Number	 	 	 	Contract. Org.	 	 	 	Investigator

Names	 	 	 	Study Type	 	 	 	Cancer Types	 	 	 	Grant Requests	 	 	 	Funding 
Requested LOC	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	

***

 

 

SCHEDULE C:

[INTENTIONALLY LEFT BLANK]

 

 

SCHEDULE D –Development Plan

VERSION 1: CLINICAL DEVELOPMENT PLAN FOR PF-338, 

AN ORAL PARP INHIBITOR

7th May 2011

Background

PF-338 is an oral, potent, PARP inhibitor (PARPi) currently in clinical development for the
treatment of human cancer. The current Pfizer-sponsored development program comprises one phase 1
trial (A4991014), that is examining the maximum dose of PF-338 that can be combined with
intravenous carboplatin chemotherapy in the treatment of solid tumors, initially using a 3-day oral
QD regimen (PF-338 on days 1-3, carboplatin (AUC5) on day 1, with 21-day cycles). A recent
amendment seeks to determine whether PF-338 can be given for longer periods of time (days 1-14, and
days 1-21 i.e. continuously). This trial is supplemented by two investigator-sponsored trials of
the intravenous formulation of PF-338 (formerly AG-014699), which could migrate across to the oral
formulation. One of these trials is a phase 1/2 in the treatment of germline BRCA mutant (gBRCA)
breast/ovarian cancer, the other a phase 2 trial in the adjuvant treatment of triple negative
breast cancer.

Clovis Oncology aims to assume responsibility for clinical development of PF-338 and seeks to
develop it in *** Clovis intends exploratory development of PF-338 as combination therapy in *** To
guide optimal design of efficacy/pivotal trials, some fundamental non-clinical and clinical
elements of PF-338 ***/safety must be established. From a non-clinical perspective:

	

	 	1.	 	In the genetic context of *** DNA damage repair defect ***, using PF-338 monotherapy,
what is the degree and duration of tumor PARP inhibition needed to cause maximal tumor cell
apoptosis and/or tumor shrinkage?
	

	

	 	a.	 	A robust *** assay is needed to generate these data.
	

	

	 	2.	 	In combination with *** in vivo, what is the degree and duration of tumor PARP
inhibition needed to cause maximal tumor cell apoptosis and/or tumor shrinkage, and under
what schedule?
	

	 
	

	 	3.	 	In vivo, does assessment of PARP activity in *** correlate sufficiently with tumor PARP
activity (and thus efficacy) to permit use of a *** assay to guide dose and schedule
selection in humans? Is plasma exposure to drug an alternative metric to predict *** effect
and efficacy?
	

Answers to these questions will inform phase 1 clinical study design, analysis and interpretation,
enabling design of phase 2/3 trials that have maximum probability of success. Until such data are
available, any phase 2/3 protocol should be considered draft. Furthermore,
as new data with other PARP inhibitors become available, changes to the clinical development plan
may also be desirable to ensure the development strategy is informed by current thinking.

The following plan addresses decision making criteria for the current phase 1 study of PF-338 in
combination with carboplatin, plus design issues for a Clovis Oncology phase 1 study of continuous
oral PF-338 monotherapy. Following on from the phase 1 program, Clovis will conduct proof of
efficacy studies *** The plans presented below assume that the *** facility

 

 

will continue to provide clinical supply to support these studies until such time Clovis can identify and complete
technology transfer to an independent supplier of API and drug product, if necessary.

Phase 1 study A4991014 — carboplatin combination

Rationale for on-going dose escalation

In protocol A4991002 (PF-338 i.v. plus temozolamide(TMZ)), *** AEs with PF-338 were mainly related
to ***, and PAR inhibition at ***, which was subsequently designated the target dose. *** It has
also not been established that the *** timepoint is the key predictor of in vivo efficacy — it is
possible *** is key, and that timepoint has not been robustly assessed to date.

Moving forward with oral dosing in protocol A4991014, the oral *** results in *** patients
suggested the AUC-equivalent of *** could be achieved by *** dosing at ***, albeit with significant
variability in AUC as demonstrated *** Despite this nearly *** difference in oral exposure at ***,
modest variability *** in oral bioavailability was seen with the current dosage form, suggesting an
oral dose of *** could reliably deliver an AUC equivalent to ***

Thus, the escalation of oral dosing at *** in the revised protocol amendment is designed to
optimize drug exposure, maximize target inhibition and duration of inhibition, and identify an MTD.
If DLT is seen at ***, we will de-escalate to *** for MTD exploration and expand to *** as
possible. Alternatively, exploration beyond *** may be necessary, depending on achievement of MTD.

Duration of PF-338 administration similarly needs optimization, with initial work focusing on the
tolerability of *** dosing, followed by *** dosing in combination with chemotherapy administered on
a *** schedule.

Go/No go decision-making: stop criteria

***

Clovis Oncology Phase 1 — Oral Continuous MTD

It is assumed that “more is better” when it comes to PARP inhibitor therapy. As monotherapy, a
reasonable goal is to provide continuous (daily) PARPi treatment. An oral, continuous daily dosing
MTD has not been established with PF-338. It is therefore necessary for Clovis Oncology to conduct
a phase 1 trial to determine this MTD. Furthermore, such a trial could be run in the US to expand
physician awareness of PF-338 in this important territory, since most work to date has been run in
the UK. During such a phase 1 trial, careful assessment of *** will be performed to establish
whether *** could be usefully used to guide optimal dosing. Patient-to-patient

 

 

variation in drug exposures is high with oral therapies, and avoidance of under-dosing may be a valuable strategy to
drive efficacy. Use of *** to achieve this goal is credible, as long as *** is simple and *** Clear
identification of a true oral monotherapy MTD is a critical early building block in the PF-338
development program. A trial synopsis is attached.

Development in *** breast cancer

Context

It has been established in a phase 2 study with olaparib that continuous monotherapy with an oral
PARPi is active and well tolerated in the treatment of *** advanced or metastatic breast cancer,
including *** mutations (Tutt et al, Lancet Oncology, 2010). Objective response rate in that study
was 41% (N=27) in heavily pre-treated patients (median 3 prior therapies) receiving the higher dose
of olaparib. Median duration of response was 144 days and median PFS was 5.7 months. The most
common grade 3/4 toxicities were fatigue, nausea, vomiting and anemia. Anecdotes of objective
responses have also been reported with intermittent i.v. PF-338 in at least 2 *** patients in phase
1 trials.

Strategy

Clovis Oncology believes PF-338 may be a more effective oral PARPi than ***for the efficacy
expected with continuous oral PF-338. To optimize patient dosing, Clovis Oncology aims to deliver a
maximally effective oral, daily dose of PF-338 to *** women with advanced/metastatic breast cancer.
*** Such a dose will likely vary between women given the high inter-patient variations in *** seen
with oral chemotherapy, and *** dosing may be an important strategy to drive efficacy *** The
practicality of such an approach will be explored during the phase 1 program where *** will be
examined. If *** can be validated clinically, the data may be used to support development of
companion diagnostic for patient dose selection. This test could be incorporated into the drug
label and ***

Clovis Oncology plans to conduct an oral monotherapy phase 2 trial of PF-338 in*** The starting
dose will be derived from the Clovis phase one study and possibly from the investigator-sponsored
trial in *** women. *** dose optimization may be deployed. *** subjects will be treated in stage 1
of this trial and if an objective response rate *** is observed with ***, then Clovis will enroll a
further *** patients and, dependent upon regulatory agency discussions, *** Our belief is that a
response rate below *** is unlikely to be sufficient to *** If a response rate of *** is observed,
then to improve the efficacy, Clovis Oncology would likely switch from monotherapy to a *** trial
with *** (and perhaps other chemotherapy such as ***, which would include *** patients (whose
tumors are ***) but add others as well.

 

 

Development in Ovarian Cancer

Context

*** mutations are found in *** of women with ovarian cancer, and responses to monotherapy PARPi ***
have been described in approximately a third of such cancer patients with advanced,
chemotherapy-refractory disease (Audeh et al, Lancet 2010). Beyond these relatively rare patients,
*** mutations have been described in a further *** of ovarian cancers (Hennessy et al, JCO 2010),
and down-regulation of *** observed in another *** of patients — suggesting that around *** of
patients with ovarian cancer are effectively *** Responses to *** monotherapy have also been
observed in these latter sets of *** patients with ovarian cancer (Gelmon et al, ASCO 2010),
although at a lower rate than in *** disease. Of note, most *** ovarian cancers are of high-grade,
serous histology, and they tend to be platinum responsive. Consequently, clinical enrichment of
PARPi-responsive patients using histology and platinum sensitivity criteria is practical. It is
expected that a maintenance study of *** in women with high-grade serous ovarian cancer with ***
disease in second relapse will be presented at ***

Strategy

Clovis Oncology intends to pursue development of PF-338 in ovarian cancer, given these consistent
and encouraging efficacy data. PARPi in the maintenance setting after*** seems to be effective in
the setting of hi-grade, highly-selected platinum-sensitive disease, which is a clinical proxy for
relative *** We have an opportunity to differentiate from *** by treating women with PF-338 *** It
is reasonable to assume that PARPi combination with chemotherapy (to improve cell kill) *** will
drive superior efficacy versus maintenance PARPi alone ***, and so a trial to test this hypothesis
will be conducted. Phase 1 studies to define oral continuous MTD and the optimized dose/schedule of
PF-338 with carboplatin will be needed as a first step (see above). The efficacy trial will then
compare *** with standard of care in hi-grade serous ovarian cancer *** The *** arms of this trial
will be: ***

As for *** may be used to guide *** dosing to ensure each subject receives an effective ***dose of
PF-338 ***

***

 

 

Clinical Protocol Synopsis

PF-338 Ph I Monotherapy

May 9, 2011

SYNOPSIS

	 	 	 
	 
	 	 
	Title

	 	A Phase I open-label, safety, *** study of PF-338 in patients with solid tumors associated with DNA
repair defects
	 
	 	 
	 
	 	 
	Study Description

	 	•    Study will encompass two phases: Phase I dose escalation (4 planned dose cohorts) and a Phase I
dose expansion at the maximum tolerated dose (MTD).

	 
	 	 
	 

	 	•    Study population for dose escalation will be any solid tumor patient who has progressed on standard
therapy and for whom the treating physician believes PARP inhibitor monotherapy may be of therapeutic
benefit.

	 
	 	 
	 

	 	•    Study population for the dose expansion phase will be patients with solid or hematologic tumors
associated with defects in DNA repair, including but not limited to, germline BRCA (gBRCA) mutations, and
abnormalities in ATM, PTEN, 11q, PALB2, etc (see inclusion criteria).

	 
	 	 
	 
	 	 
	Investigators/Study 

Sites

	 	This is a multicenter, multinational study.
	 
	 	 
	 
	 	 
	Study Duration

	 	Dose escalation is expected to last *** Dose expansion is expected to last for ***
	 
	 	 
	 
	 	 
	Study Endpoints

	 	Primary
	 
	 	 
	 

	 	•    Maximal tolerated dose of oral QD PF-338 

	 

	 	Secondary
	 
	 	 
	 

	 	•    The *** profile of oral QD PF-338 

	 
	 	 
	 

	 	•    Drug tolerability and toxicity using clinical AE monitoring and clinical laboratory testing

	 
	 	 
	 

	 	•    Tumor response and duration (according to RECIST 1.1)

	 
	 	 
	 

	 	Exploratory
	 
	 	 
	 

	 	***

	 
	 	 
	 
	 	 
	 
	 	 
	Number of Patients

	 	Up to *** patients will be enrolled; approximately *** patients in the dose escalation phase;
approximately *** in the dose expansion.
	 
	 	 
	 
	 	 
	Study Design

	 	This is a open-label, safety, *** study with standard 3+3 dose escalation design.
	 
	 	 
	 

	 	A) Dose escalation
	 
	 	 
	 

	 	•    The starting daily oral dose of PF-338 will be ***

	 
	 	 

 

 

	 	 	 
	 

	 	•    Safety observation period will be *** (one cycle)

	 
	 	 
	 

	 	•    Dose escalation will proceed from *** if DLTs (dose limiting toxicities) reported in each cohort are
<1/3 or <2/6 patients. It is possible that further dose escalation would be appropriate depending upon
tolerability, *** criteria.

	 
	 	 
	 

	 	•    DLTs will be defined by standard criteria.

	 
	 	 
	 

	 	•    The MTD will be defined as the maximum daily oral dose at which <33% of patients experience dose
limiting toxicities.

	 
	 	 
	 

	 	•    Patients enrolled in a lower dose cohort may be escalated one dose level if they experienced no DLT
during their safety observation period and if the safety observation perioed from the +1 cohort from their
dose level has been completed.

	 
	 	 
	 

	 	During the first cycle of treatment (Safety Assessment Period), patients will undergo safety, ***
assessments. Central/core laboratories will be used for *** Local imaging assessments for antitumor
efficacy (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) will be performed at Screening
and after completion of every *** cycle. AEs will be assessed from the time first dose of drug is
administered through *** after the last dose of PF-338. Other safety tests (vital signs, clinical laboratory
tests, Eastern Cooperative Oncology Group [ECOG] performance status, and physical exam) will be collected.
On-going, frequent analysis of the safety, *** data will be performed after completion of each cohort in the
dose escalation phase before choosing to advance to the next dose cohort.
	 
	 	 
	 

	 	If continuous, daily dosing with an acceptable PID is not achieved, then dosing intervals of *** out of ***
will be explored.
	 

	 	If *** out of *** dosing is not tolerated, then dosing intervals of *** out of *** will be explored.
	 
	 	 
	 

	 	B) Treatment Extension Period
	 

	 	Upon completion of the *** + safety assessment period (i.e., through ***), patients may continue to
participate in an optional Treatment-Extension Period which begins on *** PF-338 will be administered daily
during the Treatment Extension Period until tumor progression, intolerable toxicity, patient/physician
request to discontinue or death.
	 
	 	 
	 

	 	C) Dose Expansion Period
	 

	 	Upon determination of the maximally tolerated dose and assessment of the ***, safety and *** data are
completed, approximately *** patients will be enrolled at the MTD and monitored for tolerability and
efficacy. These patients will have tumors with evidence of molecular defects that are believed to impair DNA
repair capacity such that PARP inhibitor monotherapy may be of therapeutic benefit.

 

 

	 	 	 
	Study Population

	 	Key Inclusion Criteria: Dose
escalation phase
	 

	 	 
	 

	 	•    Histologically confirmed, metastatic or locally advanced solid

tumor

	 

	 	 
	 

	 	•    Progression on standard therapies

	 

	 	 
	 

	 	•    Performance Status (ECOG) 0 or 1

	 
	 	 
	 

	 	Key Inclusion Criteria: Dose
expansion phase
	 

	 	 
	 

	 	•    Histologically confirmed, metastatic or locally advanced solid

tumor or advanced hematologic malignancy

	 

	 	 
	 

	 	•    Progression on standard therapies

	 

	 	 
	 

	 	•    Evidence of tumor-related DNA repair defect, such as (but not
limited to) ***

	 

	 	 
	 

	 	•    Performance Status (ECOG) 0, 1 or 2

	 
	 	 
	 

	 	Key Exclusion Criteria
	 

	 	 
	 

	 	Any of the following criteria will exclude patients from study
participation:
	 

	 	 
	 

	 	•    Treatment with a previous PARP inhibitor, during which the
patient progressed within *** of initiating treatment and/or within ***
of consideration for this study.

	 
	 	 
	Study Treatment

	 	PF-338 will be administered as a solid tablet formulation on a
daily basis through *** for those patients enrolled in the dose
escalation phase.
	 
	 	 
	 

	 	The optional Treatment Extension Period will start on *** and continue
until patient experiences disease progression, unacceptable toxicity,
request by patient or physician to discontinue, death or termination of
the study.
	 
	 	 
	 

	 	PF-338 will be administered on a daily basis for those patients
enrolled in the dose expansion phase until patient experiences disease
progression, unacceptable toxicity, request by patient or physician to
discontinue, death or termination of the study. The dose chosen for the
expansion phase will be based on tolerability and optimal inhibition of
PAR determined in the dose escalation phase.

 

 

	 	 	 
	Withdrawal Criteria

	 	Patients may repeat cycles of PF-338 treatment until at least one of
the following criteria applies:
	 	 	 
	 

	 	•    Disease progression (based on tumor scan or clinical
status)

	 	 	 
	 

	 	•    Intercurrent illness that prevents administration of PF-338

	 

	 	•    Unacceptable toxicity

	 	 	 
	 

	 	•    Patient withdrawal of consent to further study participation

	 	 	 
	 

	 	•    Major noncompliance that may affect patient safety

	 	 	 
	 

	 	•    Pregnancy

	 	 	 
	 	 	 
	No go criteria

	 	•    Inability to dose continuously for *** or greater and
achieve *** minimum PAR inhibition

			
	***	 	 

 

 

SCHEDULE E

Existing Inventory

***

 

PFIZER provides the quotation below for additional manufacturing related services. LICENSEE shall
have 90 days from the Effective Date to request these services at the prices specified in this
quotation. If LICENSEE does not request these services in writing to PFIZER by day 90 PFIZER shall
have no obligation to manufacture additional API for LICENSEE.

Work Order #1: API Campaign targeted to deliver ~***            Quote: $*** USD

Description: PFIZER will manufacture and release an API campaign targeted to deliver ~***kg of API
for shipment (paid by LICENSEE) to LICENSEE

 

Work Order #2: Tabletting of API from Work Order #1                      Quote: $*** USD

Description: PFIZER will perform bulk tabletting and release. Expected delivery timing is by ***.

	 	•	 	Prepare and tablet a *** kg blend into 40 mg tablets (~*** anticipated)

	 
	 	•	 	Prepare and tablet a *** kg blend into 60 mg tablets (~*** anticipated)

	 
	 	•	 	Complete release testing for all lots and package into bulk drums for shipment (paid by
LICENSEE) to LICENSEE

 

Work Order #3: API Campaign targeted to deliver ~***kg of API            Quote: $*** USD

Description: PFIZER will manufacture and release an API campaign in addition to Work Order #1, that
is targeted to deliver ~***kg of API for shipment (paid by LICENSEE) to LICENSEE

PFIZER will initiate ordering of raw materials and manufacture of an additional *** kg of API,
estimated to take *** weeks from placement of orders to delivery of released API. Estimated
delivery time is by ***.

 

Work Order #4: Tabletting of API from Work Order #3                      Quote: $*** USD

Description: PFIZER will perform bulk tabletting and release.

	 	•	 	Prepare and tablet *** mg tablets (ratio of tablets TBD)

 

 

	 	•	 	Prepare and tablet *** mg tablets (ratio of tablets TBD)

	 
	 	•	 	Complete release testing for all lots and package into bulk drums for shipment (paid by
LICENSEE) to LICENSEE

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}]]