exv10w3






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.





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	 	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)





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	 	 	 	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:





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	 	(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





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	 	 	 	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.





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	 	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





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	 	 	 	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 





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	 	 	 	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





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	 	 	 	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.





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	 	 	 	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.





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	 	 	 	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”).





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	 	(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$***	 
	 





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	 	(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),




 

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	 	 	 	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.




 

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	 	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





- 21 -









 






	 	 	 	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.





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	 	(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





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	 	 	 	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




 

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	 	 	 	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.





- 32 -









 






	 	 	 	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








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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