Document:

exv10w27

Exhibit 10.27

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

COMPANION DIAGNOSTICS AGREEMENT

BETWEEN

CLOVIS ONCOLOGY, INC.

AND

ROCHE MOLECULAR SYSTEMS, INC.

 

 

This COMPANION DIAGNOSTICS AGREEMENT (this “Agreement”) is made and entered into as of the latest
date of signature below (the “Effective Date”) by and between Clovis Oncology, Inc., a Delaware
corporation, having a place of business at 2525 28th Street, Suite 100, Boulder, CO
80301 (“Clovis Oncology”) and Roche Molecular Systems, Inc., a Delaware corporation having a place
of business at 4300 Hacienda Drive, Pleasanton, California 94588 (“RMS”).

BACKGROUND

WHEREAS, RMS is a diagnostics company with expertise and capability in researching, developing,
manufacturing and marketing companion diagnostics; and

WHEREAS, Clovis Oncology is a pharmaceutical company with expertise and capability in researching,
developing, manufacturing and marketing human prophylactics and therapeutics; and

WHEREAS, RMS and Clovis Oncology desire to research, develop and commercialize a companion
diagnostic test in the field of oncology for the Markets.

NOW, THEREFORE, in consideration of the mutual covenants, agreements, representations, and
warranties contained in this Agreement, RMS and Clovis Oncology agree as follows:

1. DEFINITIONS.

As used in this Agreement, the following initially capitalized terms, whether used in the singular
or plural form, have the meanings set forth in this Article 1.

     1.1. “Affiliate” of a Party means

a) an organization, which directly or indirectly controls a Party to this
Agreement;

b) an organization, which is directly or indirectly controlled by a Party to this
Agreement;

c) an organization, which is controlled, directly or indirectly, by the ultimate
parent company of a Party;

          Control as per a) to c) of this Section 1.1 is defined as owning more than fifty percent (50%)
of the voting stock of a company or having otherwise the power to govern the financial and the
operating policies or to appoint the management of an organization.

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          With respect to RMS the term “Affiliate” shall not include any affiliates of RMS which are
involved in the discovery or development of pharmaceutical products, specifically including Chugai.

     1.2. “Agreement” shall mean this Companion Diagnostics Agreement between Clovis Oncology and
RMS.

     1.3. “Assumptions” means the assumptions as set forth in the Preliminary Project Plan and in
each Stage Plan. For clarity, as Stage Plans are implemented during the Term, Assumptions in the
Stage Plans supersede Assumptions in the Preliminary Project Plan for the relevant Stage.

     1.4. “Background IP” means all Background Know-How and Background Patents. For clarity,
Background IP owned or Controlled by Roche shall not include Background Know-How or Background
Patents related to pharmaceutical compounds or products. For further clarity, Background IP owned
or Controlled by Clovis Oncology shall only include Background Know-How or Background Patents
related to the Clovis Oncology Compound.

     1.5. “Background Know-How” means any Know-How related to (i) assays (including without
limitation the EGFR Assay), (ii) the RMS Technology, (iii) any diagnostic biomarker and/or the use
of a diagnostic biomarker with a specific therapeutic class of pharmaceutical products, (iv) any
proprietary components of the EGFR Assay or other assay, (v) the Clovis Oncology Compound, (vi)
Clovis Oncology Information, and/or (vii) the development, manufacture or use of any of the
foregoing, and in each case that either: (1) exists as of the Effective Date and is Controlled by a
Party or its Affiliates; or (2) is independently developed or acquired on or after the Effective
Date by a Party or its Affiliates, other than in connection with the performance of the Project
Plan under this Agreement.

     1.6. “Background Patents” means (i) any PCR Patent, and (ii) any Patent that claims (A) the
EGFR Assay (or other assay), (B) any diagnostic biomarker and/or the use of a diagnostic biomarker
in connection with a specific therapeutic class or pharmaceutical products, (C) any proprietary
components of the EGFR Assay (or other assay), (D) the RMS Technology, (E) the Clovis Oncology
Compound, and/or (E) the manufacture or use of any of the foregoing, in each case that either: (1)
exists as of the Effective Date and is Controlled by a Party or its Affiliates; or (2) is
independently developed or acquired on or after the Effective Date by a Party or its Affiliates,
other than in connection with the performance of the Project Plan under this Agreement.

     1.7.
“Budget” means *** the costs related to the Project, as set forth in
the Preliminary Project Plan and each Stage Plan.

     1.8. “CDA” means the confidential disclosure agreement between the Parties effective as of 30
July 2010, as amended effective 3 November 2010.

     1.9. “Changes” has the meaning as set forth in Section 2.3

     1.10. “Chugai” means Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi 2-Chome,
Chuo-ku, Tokyo 103-8324, Japan.

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     1.11. “Clinical Utility” means the validation of the clinical utility of the EGFR Assay by
using Samples, but does not include clinical reproducibility studies for the EGFR Assay.

     1.12. “Clovis Oncology Compound” means the compound identified by Clovis Oncology or any of
its Affiliates and any backup or follow-on compounds as of the Effective Date or any time
thereafter that acts as an irreversible inhibitor of mutant epidermal growth factor receptor
(EGFR).

     1.13. “Clovis Oncology Information” means all information, data, Material, and other items
that are supplied by or on behalf of Clovis Oncology or its Affiliates to RMS, or that may be
derived from or related to any visits by RMS personnel to Clovis Oncology’s or its Affiliates’
premises, pursuant to this Agreement. Clovis Oncology Information shall not include Project Results
or Inventions.

     1.14. “Clovis Oncology Inventions” has the meaning as set forth in Section 8.3.1.

     1.15. “Confidential Information” means any and all proprietary and/or confidential data,
including Clovis Oncology Information and RMS Technology, information or Know-How, of whatever kind
and in whatever form or medium, that is disclosed by or on behalf of a Party to the other Party
during the Term and in connection with this Agreement.

     1.16. “Contract Laboratories” has the meaning as set forth in Section 4.6.

     1.17. “Control” or “Controlled” means with respect to Patents or other intellectual property
assets, that a Party has the right to grant a license or sublicense to such assets without
violating the terms of any written agreement with any Third Party or incurring any financial or
other material obligation to any Third Party.

     1.18. “Deliverables” means information and/or Materials (i) generated in the course of
performance of, or otherwise arising from, the Project and (ii) to be delivered by a Party or
Affiliate to the other Party or an Affiliate, as described in the Project Plan. For clarity, the
Deliverables shall not include any items included in Clovis Oncology Information or RMS Technology.

     1.19. “Diagnostic Field” means in vitro testing for research use, or exploratory use, or as a
clinical diagnostic for use in the diagnosis and/or ongoing evaluation of a human disease or
medical condition, including the prediction and/or monitoring of a response to a therapeutic agent,
and also use as an IVD.

     1.20. “Due Date” has the meaning as set forth in Section 6.2.

     1.21. “Effective Date” means the date on which this Agreement takes effect, as set forth in
the header of this Agreement.

     1.22. “EGFR Assay” means EGFR mutation test developed by RMS to detect, identify and/or
measure EGFR mutations in human samples.

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     ***

     1.24. “FDA” means the United States Food and Drug Administration and any successor agency.

     1.25. “FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended.

      ***

     ***

     1.28. “IVD” or “in vitro diagnostic” shall mean an assay intended for use in the disease
prognosis or treatment selection / prediction, including a determination of the state of health, in
order to cure, mitigate, treat or prevent disease or sequelae, as more fully defined in 21 C.F.R. §
800 et seq.

     1.29. “Independent Development” has the meaning as set forth in Section 7.9.

     1.30. “Invention” shall mean any inventions or discoveries, whether or not patentable, first
conceived and/or reduced to practice by employees and/or agents of either Party or its Affiliates
or jointly by employees and/or agents of both Parties or their Affiliates that are generated in the
course of performance of, or otherwise arise from, the Project, together with all patent
applications and Patents claiming or covering such inventions or discoveries.

     1.31. “Joint Patents” has the meaning as set forth in Section 8.3.3.

     1.32. “Joint Invention” has the meaning as set forth in Section 8.3.2.

     1.33. “Joint Steering Committee” or “JSC” has the meaning assigned to it in Section 3.1.

     1.34. “JSC Co-Chair” has the meaning as set forth in Section 3.1.3.

     1.35. “Know-How” means any information or Materials, including, without limitation, cells,
cell lines, genes, gene fragments, gene sequences, probes, DNA, RNA, cDNA libraries, proteins,
peptides, polypeptides, plasmids, vectors, expression systems, organisms, biological substances,
and any constituents, progeny or replications thereof or therefrom, reagents, chemical compounds,
inventions whether or not patentable, improvements, practices, formula, trade secrets, techniques,
methods, procedures, protocols, knowledge, skill, experience, results, and any information
regarding marketing, pricing, distribution, cost, sales or manufacturing. Know-How does not include
any Patents or Project Results.

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     1.36. “Markets” means the countries in which RMS markets and/or sells its products during or
after the Term. For avoidance of doubt, if RMS ceases to market and/or sell products in a
particular country any time during or after the Term, such country shall be excluded from the
definition of Markets.

     1.37. “Material” shall mean the biological materials, including Samples, provided by or on
behalf of one Party to the other Party pursuant to this Agreement as set forth in the Project Plan.

     1.38. “NDA” means a New Drug Application or its equivalent (and including any amendments or
supplements thereto) that is filed pursuant to the requirements of the FDA, as defined in 21 C.F.R.
§ 314 et seq., to obtain FDA approval to commercialize a pharmaceutical product in the United
States.

     1.39. “Patent” means any existing or future (i) national, regional or international patent or
patent application in the Territory (including without limitation any provisional, divisional,
continuation, continuation-in-part, non-provisional, converted provisional, or continued
prosecution application, any utility model, petty patent, design patent and/or certificate of
invention), (ii) any extension, restoration, revalidation, reissue, re-examination and extension
(including any supplementary protection certificate and the like) of any of the foregoing patents
or patent applications, and (iii) any ex-U.S. equivalents corresponding to any of the foregoing.

     1.40. “Party” or “Parties” shall mean RMS and/or Clovis Oncology, as the context requires.

     1.41. “PCR Patent” means RMS’ Patents relating to (i) Polymerase Chain Reaction (PCR) that
cover the process and reagents for non-isothermal amplification, and detection, of a target.

     1.42. “Pharmaceutical Field” shall mean the discovery, development, manufacture, use, and/or
sale of biological or chemical substances for the medical cure, treatment, or prevention of
diseases of human beings.

     1.43. “Percentage of Completion” has the meaning as set forth  in Section 6.4.

     1.44. “Percentage of Up-Front Payments” has the meaning as set forth in Section 6.4.

     1.45. “PMA” means (i) a U.S. pre-market approval application for a Class III medical device,
including all information submitted with or incorporated by reference, and/or any new drug
application for a medical device pursuant to section 520(1) of the FD&C Act, or (ii) any analogous
application to those set forth in (i) that is filed with the relevant Regulatory Authority in a
country or region in the Markets.

     1.46. “Preliminary Project Plan” means the preliminary project plan as set forth in Exhibit A.

     1.47. “Project” means a program of activities to be performed under the Project Plan for the
development and commercialization of the EGFR Assay satisfying the Specifications

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and/or IVD incorporating the EGFR Assay in connection with the development and/or
commercialization of the Clovis Oncology Compound.

     1.48. “Project Lead” has the meaning as set forth in Section 3.2.3.

     1.49. “Project Plan” means the Preliminary Project Plan and each Stage Plan. For clarity, as
Stage Plans are implemented during the Term, Stage Plans supersede the Preliminary Project Plan for
the relevant Stage.

     1.50. “Project Results” means all information, data, reports, Deliverables, and any other
items developed or produced by RMS as a result of the Project related activities. Project Results
shall not include Inventions.

     1.51. “Project Team” has the meaning as set forth in Section 3.2.

     1.52. “Publication” has the meaning as set forth in Section 12.2.

     1.53. “Regulatory Approval” means (i) with respect to an IVD, PMA approval granted by the FDA,
(ii) with respect to a Clovis Oncology Compound, NDA approval granted by the FDA, and/or (iii) any
approval analogous to those set forth in (i) or (ii) that is granted by the relevant Regulatory
Authorities in one or more countries in the Markets.

     1.54. “Regulatory Authority” means, as applicable, the FDA, the European Medicines Agency,
and/or any other analogous regulatory authority or agency in a country or region in the Markets.

     1.55. “RMS Inventions” has the meaning as set forth in Section 8.3.1.

     1.56. “RMS Technology” means RMS’ proprietary technologies, such as technologies which it may
legally license, relating to the EGFR Assay or to RMS’ instruments or platforms, including
intellectual property therein which are acquired, possessed, developed, or Controlled by RMS during
the Term of this Agreement, and any information, data and materials relating thereto. RMS
Technology shall not include Project Results or Inventions.

     1.57. “Sample or Samples” means any patient sample, human cell line, tissue, blood sample,
clinical isolate, or other similar human-derived material that is collected or otherwise made
available in accordance with the Agreement for use in connection with the Project Plan, including
without limitation for the development, testing or validation of the EGFR Assay or IVD.

     1.58. “Specifications” means the applicable testing specifications, such as sensitivity,
specificity and sample type for the EGFR Assay and/or IVD as mutually agreed upon by the Parties
based on the outcome of the Feasibility Study.

     1.59. “Stage(s)” means each stage of the Project as identified in the Preliminary Project
Plan.

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     1.60. “Stage Budget” means the costs related to each Stage as set forth in the Preliminary
Project Plan.

     1.61. “Stage Costs” mean the breakdown of costs related to each Stage as set forth in each
Stage Plan. For clarity, as Stage Plans are implemented during the Term, Stage Costs supersede
Stage Budgets for the relevant Stage.

     1.62. “Stage Plan(s)” means a project plan detailing the specific activities to be conducted
for each Stage which shall contain, as a minimum, the elements as set forth in Exhibit B, and a
mutually agreed payment schedule for the corresponding Stage Costs.

     1.63. “Stage Start Date” means the anticipated start date of each Stage as determined by the
Project Team.

     1.64. “Technical EGFR Assay Development” means the development of the EGFR Assay, including
software development, the technical validation and verification of the EGFR Assay, clinical
reproducibility studies of the EGFR Assay and the manufacturability of the EGFR Assay, but does not
include Clinical Utility.

     1.65. “Territory” means worldwide.

     1.66. “Term” has the meaning as set forth in Section 13.1.

     1.67. “Third Party” means any individual or entity other than RMS, RMS’ Affiliates, Clovis
Oncology, or Clovis Oncology’s Affiliates.

2. PROJECT AND PROJECT PLAN.

     2.1. Project. Clovis Oncology and RMS will perform the Project in accordance with the Project
Plan and this Agreement for the development of the EGFR Assay and submission for Regulatory
Approval for the IVD. Work on such Project Plan will be initiated as soon as practicable.

     2.2. Preliminary Project Plan and Stage Plans. The Parties agreed to a Preliminary Project
Plan which during the Term shall for each Stage be successively replaced by the Stage Plans agreed
upon, approved and signed off by the Project Team. If the Project Team is unable to agree on a
Stage Plan, the escalation process according to Section 3.2.4 shall apply. The Project Team shall
have authority to approve the relevant Stage Plan if and to the extent the Stage Costs in the
relevant Stage Plan do not exceed the Stage Budget. If and to the extent the Stage Costs in the
relevant draft Stage Plan exceed the Stage Budget, the Project Team shall submit to the JSC the
relevant Stage Plan and only the JSC shall have the authority to approve the relevant Stage Plan,
provided that such Stage Plan shall not become effective unless agreed upon in writing and signed
by authorized representatives of Clovis Oncology and RMS. To the extent the Stage Costs in a
relevant Stage Plan materially exceed the Stage Budget, the Parties shall negotiate in good faith
whether ***  the exceeding costs shall be included in the Budget as set forth in
Section 1.7, or whether a different allocation of such exceeding costs shall be implemented. If the
JSC is unable to approve a Stage Plan, the escalation process

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according to Sections 3.1.4 and 3.1.5, respectively, shall apply. Each Stage Plan shall be approved
by the Project Team or the JSC, respectively, *** weeks prior to the relevant Stage
Start Date.

     2.3. Modifications to Stage Plans. If either Party becomes aware of any changes of
Assumptions or of any other circumstances outside of the control of RMS, such as changes in the
regulatory environment, which could reasonably be expected to result in a material impact on a
given Stage Plan (the “Changes”), then such Changes shall be promptly reported to the other Party,
and the Parties shall negotiate in good faith an amended Stage Plan and Stage Budget taking into
account such Changes. For any amendments of a Stage Plan relating to Changes or for any
modifications of a Stage Plan independent of any Changes which does not lead to an increase of the
amended or modified Stage Costs the Project Team shall have the authority to agree, approve and
sign off such modified Stage Plan. If the Project Team is unable to agree on an amended or modified
Stage Plan, the escalation process according to Section 3.2.4 shall apply. If and to the extent the
amendment or modification of a Stage Plan leads to an increase of the amended or modified Stage
Costs, the Project Team shall submit to the JSC the amended or modified Stage Plan and only the JSC
shall have the authority to approve such amended or modified Stage Plan, provided that such amended
or modified Stage Plan shall not become effective unless agreed upon in writing and signed by
authorized representatives of Clovis Oncology and RMS. To the extent the amendment or modification
of a Stage Plan leads to a material increase of the amended or modified Stage Costs, the Parties
shall negotiate in good faith whether ***  the exceeding costs shall be included
in the Budget as set forth in Section 1.7, or whether a different allocation of such exceeding
costs shall be implemented. If the JSC is unable to approve an amended or modified Stage Plan, the
escalation process according to Sections 3.1.4 and 3.1.5, respectively, shall apply.

     2.4. Project Obligations and Responsibilities.

          2.4.1. Diligence. Each Party will use commercially reasonable efforts to successfully
complete the activities for which it is responsible under the Project Plan in accordance with
applicable standards currently recognized by the Parties’ profession or industry. Each Party shall
be responsible for the quality, technical accuracy, and completeness of all Project Results, and
any other items to be generated or provided by them under this Agreement. Each Party shall also be
responsible for the professional quality, training, and supervision of all its and its Affiliates’
personnel who perform any activities under the Project Plan.

          2.4.2. Compliance with Laws and Regulations. Each of RMS and Clovis Oncology shall, and shall
ensure that their respective Affiliates shall, comply with all applicable laws, rules and
regulations in connection with the performance of the Project Plan. In addition, each of RMS and
Clovis Oncology shall, and shall ensure that their respective Affiliates shall, comply, as
applicable, with current Good Laboratory Practices, Good Clinical Practices and/or Good
Manufacturing Practices in connection with the performance of the Project Plan.

          2.4.3. Timelines for Performance. The Parties will use commercially reasonable efforts to
complete their respective obligations under the Project Plan within the timeframes specified in the
Project Plan. Each Party will promptly inform the other Party in the event that it anticipates or
experiences a delay in the completion of such activities. Each Party

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shall be responsible for any delay or failure by it (or its Affiliates) to timely complete its
obligations under the Project Plan using commercially reasonable efforts, except to the extent that
(i) such failure or delay is caused by a delay or failure of performance by the other Party or any
Contract Laboratory, or (ii) as may otherwise be mutually agreed in writing by the Parties.

          2.4.4. Responsibility for EGFR Assay. Except as may otherwise be expressly agreed to in
writing by the Parties, RMS shall be responsible for the performance of any activities related to
the development and commercialization of the EGFR Assay and/or IVD included in the Project Plan.

          2.4.5. Responsibility for Clovis Oncology Compound. Clovis Oncology and its Affiliates are
and shall remain responsible, at their own expense and as determined in their sole discretion, for
the development and commercialization of the Clovis Oncology Compound.

3. GOVERNANCE.

     3.1. Joint Steering Committee. Within thirty (30) calendar days after the Effective Date, the
Parties will form a joint steering committee (the “Joint Steering Committee” or “JSC”) comprised of
two (2) employee representatives from RMS and two (2) employee representatives from Clovis
Oncology. Each representative to the JSC will be appointed by a Party, and also may be replaced at
any time by that Party, upon prior written notice to the other Party. A Party’s appointed JSC
members will have appropriate expertise, experience and decision making authority to carry out
their responsibilities as members of the JSC, and may not at the same time serve as a member of the
Project Team.

          3.1.1. Responsibilities of the JSC. The primary purpose of the JSC will be to provide
oversight and strategic planning for the Project being carried out under the Agreement. Specific
JSC responsibilities shall include:

	

	 	(i)	 	to approve any Stage Plans submitted to the JSC by the Project
Team pursuant to Section 2.2 *** weeks prior to the relevant
Stage Start Date;
	

	 
	 	(ii)	 	to approve any amended or modified Stage Plans submitted to the
JSC by the Project Team pursuant to Section 2.3;
	 
	 	***	 	
	 
	 	(iv)	 	the resolution of any disputes referred to it by a Project Team
in accordance with Section 3.1.4.

          3.1.2. JSC Meetings. The JSC will meet at least once per calendar year, or more frequently as
needed, at such times as may be agreed to by the Parties. The JSC will determine its meeting
locations, and whether to conduct a meeting in-person, by teleconference, or videoconference. Each
Party shall have the right to request a special meeting of the JSC at

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any time as necessary to address disputes or other matters within the scope of the JSC’s
responsibilities by providing the other Party with written notice to that effect. The Parties shall
schedule and convene such JSC as soon as practicable following such notice. Each Party may, from
time-to-time and with prior written notice to the JSC members of the other Party, invite Project
Team members and/or others of its employees, consultants or agents to attend relevant portions of a
JSC meeting as necessary. A Party shall notify the other Party in writing in the event that it
wishes to invite a consultant, agent or other Third Party contractor to attend a JSC meeting. Any
such notice shall be provided at least five (5) business days prior to the relevant JSC meeting and
shall identify the relevant consultant or contractor, and briefly describe the reasons that the
requesting Party wishes to include the Third Party in the meeting. The attendance and participation
of such consultant or contractor shall be subject to the prior written consent of the Party
receiving such notice (such consent not to be unreasonably withheld). Any such consent granted by a
Party shall be conditioned upon the consultant or contractor being bound by a written
confidentiality and non-use agreement that is reasonably acceptable to the consenting Party. Notice
and approval of the attendance of a consultant, agent or other Third Party contractor at a
subsequent JSC meeting shall not be required for any consultant, agent or other Third Party
contractor who was previously approved by the other Party and remains bound by an appropriate
written confidentiality and non-use agreement at the time of the JSC meeting. The Parties
respective JSC Co-Chairs (as defined below) shall be responsible for ensuring compliance with the
foregoing. Each Party is responsible for all costs and expenses incurred by it in connection with
its participation in the meetings of the JSC.

          3.1.3. JSC Chairpersons. Meetings of the JSC shall be jointly chaired by one representative
of each Party to be designated from among such Party’s two appointed representatives to the JSC
(the “JSC Co-Chairs”). A Party may change its designated JSC Co-Chair by providing written notice
to the other Party to that effect. The JSC Co-Chairs will be responsible for establishing meeting
schedules and agendas, and for generating mutually acceptable minutes of JSC meetings. Each Party’s
JSC Co-Chair can delegate such administrative aspects of JSC meetings to one of such Party’s
members on the Project Team. The JSC Co-Chairs may elect to rotate and/or otherwise allocate those
responsibilities between themselves.

          3.1.4. JSC Decisions and Dispute Resolution. The JSC will make its decisions, and approve all
of its actions, by unanimous consent of the Parties’ representatives, with each Party having a
single vote. Except as otherwise set forth in this Agreement, if the JSC is unable to reach
agreement on any matter within the JSC’s authority within thirty (30) calendar days after the
matter is first referred to the JSC, then the matter will be resolved by the Parties’ Senior
Officers pursuant to Section 3.1.5. The foregoing notwithstanding, the Parties agree that disputes
on certain matters shall be excluded from resolution through the procedures of either Section 3.1.5
or Article 14, and that instead one Party (as indicated below) shall have final decision making
authority with regard to such matters as follows:

	 	(i)	 	Clovis Oncology shall have final decision making authority with
respect to all matters related to (1) the development of the Clovis Oncology
Compound (including without limitation to design and conduct clinical trials
involving the Clovis Oncology Compound), and (2) the commercialization of the
Clovis Oncology Compound in the Territory

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	 	 	 	(including without limitation the decision of whether or not to sell or
discontinue selling the Clovis Oncology Compound in a country or region).
	 
	 	(ii)	 	RMS shall have final decision making authority with respect to
matters related to (1) the design and configuration of the EGFR Assay and IVD,
or (2) the commercialization of the EGFR Assay or IVD in the Territory other
than in the USA, the European Union, Japan and China (including without
limitation the decision of whether or not to sell or discontinue selling the
IVD in a country or region other than in the USA, the European Union, Japan and
China).

The Party having such final decision making authority may exercise that authority through the
exercise of a casting vote by its JSC Co-Chair on relevant subject matter, or through such other
actions as it determines are necessary; provided, however, that any such final decisions or other
actions made by such Party, shall not result in imposing any new or additional financial or other
obligations on the other Party under this Agreement.

          3.1.5. Resolution of Disputes by Senior Officers. Except as otherwise expressly provided in
Section 3.1.4, any unresolved disagreement or dispute arising at the JSC will be referred to the
Parties’ respective senior officers designated below (the “Senior Officers”), or their respective
designees, for resolution through good faith negotiations over a period of up to thirty (30)
calendar days. To the extent that a Party’s Senior Officer delegates his/her responsibility for
resolution of a dispute to another officer of such Party, such Party shall ensure that the designee
has all necessary and appropriate authority to fully resolve the Dispute on behalf of such Party.
Such designated executive officers are as follows:

          For Clovis Oncology:  President and CEO

          For RMS:  President and CEO

     3.2. Project Team. The Parties will form a joint project team for the Project being carried
out under this Agreement (the “Project Team”). Membership of the Project Team shall be comprised of
employee representatives from RMS or its Affiliates and employee representatives from Clovis
Oncology. Each Party’s Project Team representatives shall have appropriate technical expertise and
experience in disciplines relevant to the Project (including without limitation assay development,
clinical development, regulatory matters, and project management). Any of a Party’s representatives
to the Project Team may be replaced at any time by that Party, upon prior written notice to the
other Party. The Project Team shall be established within thirty (30) calendar days after the
Effective Date.

          3.2.1. Responsibilities of the Project Team. The primary responsibility of the Project Team
will be to coordinate and manage the performance of activities being carried out under the Project
Plan, and to facilitate communications and the exchange of data and information related to the
Project. Specific Project Team responsibilities shall include:

	 	(i)	 	to set each Stage Start Date ***  weeks prior to
the preliminary stage start date as set forth in the Preliminary Project Plan;

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	 	(ii)	 	to agree, approve and sign off Stage Plans pursuant to Section
2.2 *** weeks prior to the relevant Stage Start Date;
	

	 
	 	(iii)	 	periodic review and evaluation of the status, progress and
results of work being performed under the Project Plan; and
	 
	 	(iv)	 	to agree, approve and sign off amended or modified Stage Plans
in accordance with Section 2.3.

          3.2.2. Project Team Meetings. Each of the Project Teams will meet at least once each calendar
quarter, or more frequently as needed, according to a schedule to be established by the Project
Team. The Project Team will determine its meeting locations, and whether to conduct a meeting
in-person, by teleconference, or videoconference. Each Party is responsible for all out-of-pocket
costs and expenses incurred by it in connection with its participation in meetings of the Project
Team. Each Party may invite others of its permanent or temporary employees to attend and
participate in relevant portions of the Project Team meeting as necessary. A Party shall notify the
other Party’s Project Lead in writing in the event that it wishes to invite a consultant, agent or
other Third Party contractor to attend a Project Team meeting. Any such notice shall be provided at
least five (5) business days prior to the relevant Project Team meeting and shall identify the
relevant consultant or contractor, and briefly describe the reasons that the requesting Party
wishes to include the Third Party in the meeting. The attendance and participation of such
consultant or contractor shall be subject to the prior written consent of the Party receiving such
notice (such consent not to be unreasonably withheld). Any such consent granted by a Party shall be
conditioned upon the consultant or contractor being bound by a written confidentiality and non-use
agreement that is reasonably acceptable to the consenting Party. Notice and approval of the
attendance of a consultant, agent or other Third Party contractor at a subsequent Project Team
meeting shall not be required for any consultant, agent or other Third Party contractor who was
previously approved by the other Party and remains bound by an appropriate written confidentiality
and non-use agreement at the time of the Project Team meeting. The Parties respective Project Leads
shall be responsible for ensuring compliance with the foregoing.

          3.2.3. Project Leads. Each Party shall designate one of its appointed members of the Project
Team as its primary point of contact and lead representative for matters related to the Project
(each, a “Project Lead”). Meetings of the Project Team shall be jointly chaired by the Project
Leads. A Party may change its designated Project Lead by providing written notice to the other
Party to that effect. The Project Leads will be responsible for establishing meeting schedules and
agendas, for generating mutually acceptable minutes of Project Team meetings and for any other
administrative matters related to Project Team meetings. The Project Lead may elect to delegate
these responsibilities to other members of the Project Team. The Project Leads may elect to rotate
and/or otherwise allocate those responsibilities between themselves.

          3.2.4. Project Team Decisions. The Project Team will make its decisions, and approve all of
its actions, by unanimous consent of the Project Team representatives, with each Party having a
single vote. All decisions of the Project Team shall be documented in the Project Team’s meeting
minutes. If the Project Team is unable to resolve a dispute regarding any matter

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within the Project Team’s authority, the matter will be referred to the JSC for resolution in
accordance with Section 3.1.4.

4. DEVELOPMENT ACTIVITIES.

     4.1. Technical EGFR Assay Development. RMS shall be responsible and conduct the Technical
EGFR Assay Development as set forth in the Project Plan.

     4.2. Clinical Utility. Clovis Oncology and RMS shall be jointly responsible for Clinical
Utility of the EGFR Assay as set forth in the Project Plan.

     4.3. Samples. Clovis Oncology will provide RMS with access or otherwise make available any
Samples necessary or relevant for the Clinical Utility at no charge and in agreed upon formats,
which shall include actual Samples, demographic data, test results, and clinical data for the
screening population and for enrolled patients. RMS shall use commercially reasonable efforts to
acquire Samples for the Technical EGFR Assay Development. In the event that RMS is unable to obtain
sufficient quantity of such Samples for the Technical EGFR Assay Development or the Parties
determine that Samples from sources available to Clovis Oncology are advantageous for the timely
completion of the Technical EGFR Assay Development, Clovis Oncology shall use commercially
reasonable efforts to acquire and provide supplementary Samples. The cost of acquiring such
supplementary Samples for the Technical EGFR Assay Development will be allocated as set forth in
the Budget. Each of Clovis Oncology and RMS hereby represents and warrants to the other Party that:
(1) the collection, storage, transportation, and delivery of Samples supplied by or on its behalf
pursuant to this Section 4.3, was performed in compliance with all applicable laws, rules and
regulations; and (2) that it (or a Third Party acting on its behalf) has obtained all necessary
approvals and appropriate informed consents for the collection or use of such Samples pursuant to
this Agreement. The Party providing the Samples will, upon request, provide the other Party (i)
with documentation of such approvals and consents, or (ii) with a written confirmation that all
necessary approvals and appropriate informed consents for the collection or use of such Samples
pursuant to this Agreement have been obtained. Each Party hereby further represents and warrants to
the other Party that any Samples it has provided or otherwise made available for use in connection
with the Project Plan may be used as contemplated in this Agreement and the Project Plan without
any obligations of compensation to donors of such Samples or any other Third Party for the
intellectual property associated with, or commercial use of, the Samples for any purposes.

     4.4. Materials. Each Party may procure Materials for the conduct of the Project. Such
Materials shall be owned by the Party which procured the Materials. Each Party will use Materials
of the other Party only for the purposes set forth in this Agreement and the Project Plan, and will
not transfer or disclose such Materials to any Third Party, except in compliance with the Project
Plan and any other applicable terms of this Agreement. Upon the procuring Party’s request, any
remaining Materials will be disposed of according to the instructions of the procuring Party.

     4.5. Access to Protocols and Other Documentation. Each Party will, upon request, provide the
other Party with reasonable access to documents and records in its or its Affiliates’ possession or
control related to the EGFR Assay or IVD and/or Clovis Oncology Compound that

Page 14 of 35

 

are necessary or useful for the performance of the Project Plan or this Agreement. This shall
include, without limitation, (1) Clovis Oncology providing RMS with reasonable access to its
clinical trial protocols involving the Clovis Oncology Compound if and to the extent necessary to
enable RMS to perform activities included in the Project Plan, and (2) RMS providing Clovis
Oncology with reasonable access to information and documentation such as technical reports
regarding the EGFR Assay and related technology.

     4.6. Third Party Testing Laboratory Services. The Parties anticipate using Third Party
contract laboratories for the performance of certain Sample testing and/or other activities within
the scope of the Project Plan (the “Contract Laboratories”). The selection and use of such Third
Party contractors shall be managed in accordance with the terms of this Section 4.6.

          4.6.1. Clovis Oncology Contracting with Laboratories. RMS and Clovis Oncology shall agree on
the Contract Laboratories to perform the Clinical Utility of the EGFR Assay. RMS shall ensure that
the Contract Laboratories are properly certified to do the Clinical Utility work according to the
Project Plan and this Agreement.

          4.6.2. EGFR Assay Manufacture and Supply. Except as otherwise expressly provided in the
Project Plan, RMS or its Affiliates is solely responsible for the manufacture and supply of the
EGFR Assay to the Contract Laboratories for Clinical Utility or other similar activities involving
use of the EGFR Assay under the Project Plan.

          4.6.3. EGFR Assay Support. Except as may otherwise be expressly provided in the Project Plan,
RMS will be responsible for providing training, support and any software upgrades to the Contract
Laboratories to perform Clinical Utility or other similar activities involving use of the EGFR
Assay under the Project Plan. RMS shall also be responsible for ensuring that each such Contract
Laboratory has or is provided the necessary equipment (including any upgrades) needed to perform
the EGFR Assay, which equipment shall be provided on terms to be agreed upon between RMS and the
Contract Laboratories; provided that such terms will be consistent with the standard terms
currently being offered by RMS to its other Third Party customers for such equipment (the “Standard
Terms”). For clarity, any training, support, software update and equipment (including any
upgrades) provided by RMS to the Contract Laboratories (the “Support”) will be against remuneration
by the Contract Laboratories consistent with the Standard Terms. If a Contract Laboratory is not
willing to enter into an agreement with RMS based on the Standard Terms, or if a Contract
Laboratory does not fully pay for such Support according to the Standard Terms, RMS shall not be
obliged under this Agreement or the Project Plan to provide Support to such Contract Laboratory.

     4.7. Applications for Regulatory Approval. Clovis Oncology shall at its own expense be
responsible for and control the preparation and submission of any applications for Regulatory
Approval, and for obtaining and maintaining Regulatory Approvals, in the Territory for any Clovis
Oncology Compound. RMS or its Affiliates shall be responsible for and control the preparation and
submission of any applications for Regulatory Approval, and for obtaining and maintaining
Regulatory Approvals, in the Territory for any IVD being developed in accordance with the Project
Plan and this Agreement.

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          4.7.1. Collaboration on Regulatory Strategy. Clovis Oncology and RMS (acting through the
Project Team) will collaborate on the regulatory strategy in the Markets for obtaining Regulatory
Approvals for the combination use of the Clovis Oncology Compound in conjunction with the IVD
developed under the Project Plan and this Agreement, and in the preparation and/or exchange of any
documentation necessary to support any INDs, NDAs, PMAs or other applications for such Regulatory
Approvals. The Parties will also consult and coordinate their respective efforts to implement such
regulatory strategies in the Markets, including without limitation by meeting jointly with the
applicable Regulatory Authorities to ensure that the regulatory strategy for the EGFR Assay and/or
IVD and Clovis Oncology Compound is acceptable to such Regulatory Authorities, and by keeping each
other reasonably informed with respect to any related regulatory interactions with the FDA and
other Regulatory Authorities in the Markets.

          4.7.2. Authorizations. Each of Clovis Oncology and RMS shall, and/or shall ensure that their
relevant Affiliates shall, upon request provide the other Party (and such Party’s designated
Affiliates) with any appropriate letters and/or other similar documentation necessary to authorize
such other Party (and/or its Affiliates) to cross-reference and rely upon the contents of any of
its (or its Affiliates’) Regulatory Approvals in the Markets related to (1) in the case of RMS, an
IVD or (2) in the case of Clovis Oncology, a Clovis Oncology Compound, for the purposes of, as
applicable, (i) the performance of the Project Plan under this Agreement and/or (ii) the filing,
obtaining and maintaining of Regulatory Approvals for an IVD or Clovis Oncology Compound pursuant
to and in accordance with the licenses granted under this Agreement.

     4.8. Reports. Each Party will keep the other Party informed of its progress and results in
performing the Project Plan under this Agreement. This shall include, without limitation: (i) the
exchange of information and communication of results under the Project Plan at each Project Team
meeting, and (ii) the Project Team providing the JSC with an annual summary of the activities
performed and results achieved in connection with the Project Plan. For clarity, the foregoing
shall not be construed as obligating Clovis Oncology to provide RMS, the JSC or any Project Team
with any data, information or status reports related to the development of any Clovis Oncology
Compound.

     4.9. Licenses and Access to Third Party Technology. With respect to the EGFR Assay, RMS
and/or its Affiliates shall be responsible, *** for obtaining and
maintaining any licenses or other rights to access or use any Third Party Patents, technology or
Know-How that are necessary for the development, manufacture, use or commercialization by RMS of
the EGFR Assay or IVD pursuant to this Agreement. Clovis Oncology and/or its Affiliates shall be
solely responsible, at its or their own expense, for obtaining and maintaining any licenses or
other rights to access or use any Third Party Patents, technology or Know-How that are necessary or
useful for the development, manufacture, use or commercialization of any Clovis Oncology Compound.

5. COMMERCIALIZATION.

     5.1. Joint Commercialization Efforts. Clovis Oncology and RMS will use commercially
reasonable efforts to collaborate on joint promotional efforts ***

Page 16 of 35

 

*** Clovis Oncology will use commercially reasonable efforts to ensure that
any Third Parties involved in the marketing and sale of the Clovis Oncology Compound will
collaborate with RMS and its Affiliates on such joint promotional efforts.

     5.2. RMS Obligations. RMS and its Affiliates shall use commercially reasonable efforts, at
their expense, to make available and promote the EGFR Assay and/or IVD to RMS’ target customer
segment in the Markets.

     5.3. Clovis Oncology Obligations. Clovis Oncology and its Affiliates (and any Third Parties
involved in marketing the Clovis Oncology Compound) shall use commercially reasonable efforts, at
their expense, to (i) make available and promote the Clovis Oncology Compound, and (ii), as
permitted by applicable laws and regulations, to promote testing with the EGFR Assay and/or IVD as
a standard of care to the Clovis Oncology target customer segment.

6. CONSIDERATION.

     6.1. Consideration. In consideration for the work to be performed by RMS under the Project
Plan and the relevant licenses and other rights granted to Clovis Oncology hereunder, Clovis
Oncology shall compensate RMS for the amounts set forth in the Budget. The Budget shall be binding
upon the Parties, unless (i) the Budget requires modifications due to Changes as set forth in
Section 2.3, in which case the Parties shall proceed as set forth in Section 2.3; or (ii) the
actual costs of the Project (or a Stage) exceed the Budget (or any Stage Costs) due to a delay or
failure of performance by Clovis Oncology, in which case Clovis Oncology shall be required to pay
such additional costs to RMS. Except as set forth in this Agreement and in the Project Plan, each
Party will bear their own costs and expenses with respect to this Agreement.

     6.2. Invoices and Payments. Clovis Oncology will make payments to RMS of any amounts due and
payable according to the Budget and payment plan as set forth in each Stage Plan pursuant to
invoices to be provided by RMS within ***  calendar days after the payment date as set forth
in each Stage Plan. Clovis Oncology will pay to RMS all amounts properly due and payable under
such invoices within *** calendar days following receipt of the original invoice (the
“Due Date”). All payments shall be invoiced and made in U.S. dollars by bank wire transfer of
immediately available funds to such bank account in the United States as may be designated in
writing by RMS.

     6.3. Late Payments. If Clovis Oncology fails to pay any undisputed amount specified in this
Agreement on or before the Due Date thereof, the amount owed will
bear interest *** from the Due Date until paid, provided, however,
that if this interest rate is held to be unlawful or unenforceable for any reason, the interest
rate will be the maximum rate allowed by law at the time payment is due.

     6.4. Early Termination. In the event of early
termination of the Agreement prior to completion of the Project, the
JSC shall determine the degree of completion in percent of the Stage the Project is in at the time of termination (the
“Percentage of Completion”). The JSC shall determine furthermore the amount resulting from the difference between
Percentage of Completion and the percentage of any up-front payments previously made by Clovis Oncology pursuant to
Sections 6.1 and 6.2 as compared to the relevant Stage Costs (the “Percentage of

Page 17 of 35

 

Up-Front Payments”). If the Percentage of
Completion is higher than the Percentage of Up-Front Payments, Clovis Oncology
agrees to pay RMS, the resulting difference amount within *** calendar days following the termination of the Agreement, if
the Percentage of Completion is lower than the Percentage of Up-Front Payments, RMS agrees to pay Clovis Oncology, the
resulting difference amount within *** calendar days following the termination of the Agreement.

     6.5. Taxes. To the extent that the goods or services to be provided hereunder are subject to
any sales, use, rental, personal property, value added, or any other taxes, payment of said taxes
is Clovis Oncology’s responsibility, subject to any applicable exemption entitlement.

7. LICENSES.

     7.1. License to Clovis Oncology’s Background IP. Clovis Oncology hereby grants RMS and its
Affiliates a non-exclusive, royalty free license in the Territory under Clovis Oncology’s and its
Affiliates’ Background IP to research, develop, make, have made, use, sell, offer for sale, import
and otherwise exploit the EGFR Assay and/or IVD developed under the Project Plan in accordance with
the Project Plan and this Agreement. The license granted in this Section 7.1 is not sublicensable,
except to RMS’ Affiliates or any Third Party engaged in the development, manufacture or sale of the
EGFR Assay and/or IVD.

     7.2. License to RMS’ Background IP. RMS hereby grants to Clovis Oncology and its Affiliates a
non-exclusive, royalty free license in the Territory under RMS’ Background IP: (i) to use the EGFR
Assay and/or IVD developed under the Project Plan in accordance with the Project Plan and this
Agreement; and (ii) to research, develop, make, have made, use, sell, offer for sale, import and
otherwise exploit the Clovis Oncology Compound in conjunction with the EGFR Assay and/or IVD
developed under the Project Plan; provided, however, that such licenses shall not include any
rights under the PCR Patents. The license granted in Section 7.2(i) is not sublicensable, except to
Clovis Oncology’s Affiliates performing activities under the Project Plan and this Agreement; the
license granted in Section 7.2(ii) may be sublicensed to Clovis Oncology’s Affiliates or any Third
Party engaged in the development, manufacture or sale of the Clovis Oncology Compound.

     7.3. License to Clovis Oncology Inventions. Clovis Oncology hereby grants RMS and its
Affiliates a non-exclusive, royalty free license in the Territory under the Clovis Oncology
Inventions to research, develop, make, have made, use, sell, offer for sale, import and otherwise
exploit the EGFR Assay or IVD developed under the Project Plan in accordance with the Project Plan
and this Agreement. The license granted in this Section 7.3 is not sublicensable, except to RMS’
Affiliates or any Third Party engaged in the development, manufacture or sale of the EGFR Assay
and/or IVD.

     7.4. License to RMS Inventions. RMS hereby grants to Clovis Oncology and its Affiliates a
non-exclusive, royalty free license in the Territory under the RMS Inventions: (i) to use the EGFR
Assay or IVD developed under the Project Plan in connection with the performance of the Project
Plan and this Agreement, and (ii) to research, develop, make, have made, use, sell, offer for sale,
import and otherwise exploit the Clovis Oncology Compound in conjunction with the EGFR Assay and/or
IVD developed under the Project Plan. The license

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granted in Section 7.4(i) is not sublicensable, except to Clovis Oncology’s Affiliates
performing activities under the Project Plan and this Agreement; the license granted in Section
7.4(ii) may be sublicensed to Clovis Oncology’s Affiliates or any Third Party engaged in the
development, manufacture or sale of the Clovis Oncology Compound.

     7.5. Licenses to Joint Inventions. In order to avoid any unanticipated limitation on the
Parties’ ability to use and exploit Joint Inventions, where and when necessary as required by law,
each Party hereby grants to the other Party and its respective Affiliates, a worldwide,
non-exclusive, sublicensable, royalty-free license under each Party’s interest in and to the Joint
Inventions for any and all purposes. Notwithstanding the foregoing, Clovis Oncology hereby grants
RMS and its Affiliates a worldwide, exclusive, transferable, sublicenseable, royalty free license
under Clovis Oncology’s interest in the Joint Inventions for any and all purposes in the Diagnostic
Field. RMS hereby grants Clovis Oncology and its Affiliates a worldwide, exclusive, transferable,
sublicenseable, royalty free license under RMS’ interest in the Joint Inventions for any and all
purposes in the Pharmaceutical Field.

     7.6. Project Results. Clovis Oncology hereby grants RMS and its Affiliates a worldwide,
exclusive, transferable, sublicenseable, royalty free license under Clovis Oncology’s interest in
the Project Results for any and all purposes in the Diagnostic Field. RMS hereby grants Clovis
Oncology and its Affiliates a worldwide, exclusive, transferable, sublicenseable, royalty free
license under RMS’ interest in the Project Results for any and all purposes in the Pharmaceutical
Field.

     7.7. *** Covenant. RMS hereby agrees and
covenants that it shall not, and shall ensure that its Affiliates do not,
directly or indirectly through any Third Party, undertake any legal proceedings or other actions to assert the ***
Patents or any
other intellectual property that is subject to the *** against Clovis Oncology or its Affiliates in connection with or
 as a result
of: (i) the performance of any activity under the Project Plan under this Agreement; and/or (ii) the use in accordance
 with the
terms of this Agreement of the EGFR Assay or IVD in connection with the development, manufacture or sale of the Clovis
Oncology Compound.

     7.8. No Other Rights; No Implied Licenses. Only the licenses and other rights expressly
granted by one Party to the other Party under terms of this Agreement are of any legal force or
effect. No other licenses or other rights are granted, conveyed or created (whether by implication,
estoppel or otherwise).

     7.9. Independent Development Efforts. The Parties acknowledge and agree that Clovis Oncology,
RMS and their Affiliates will retain the right to perform independent development activities as
further outlined in this Section 7.9. As used herein, the term “Independent Development” by a Party
shall mean undertaking development work, except if and to the extent permissible according to this
Agreement, without the aid, application or use of any of the other Party’s Background IP, the other
Party’s Inventions and/or Confidential Information.

          7.9.1. Independent Development by Clovis Oncology. Clovis Oncology and its Affiliates have
and shall retain ownership of all rights, title, and interest in and to the Clovis

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Oncology Compound and are free to conduct Independent Development involving the use of the
Clovis Oncology Compound for any purpose (whether alone or in combination with any other product or
service) and in collaboration with any Third Party. The foregoing shall include, without
limitation, Clovis Oncology’s rights to independently utilize diagnostic tests (including in vitro
diagnostic products or companion diagnostic products), other than the EGFR Assay or IVD developed
under the Project Plan, in connection with the development or commercialization of the Clovis
Oncology Compound or any other compound, whether alone or in collaboration with Third Parties.

          7.9.2. Independent Development by RMS. RMS and/or its Affiliates have and shall retain
ownership of all rights, title, and interest in and to the EGFR Assay and IVD and are free to
conduct Independent Development involving the use of the EGFR Assay and/or IVD for any purpose
(whether alone or in combination with any other product or service) and in collaboration with any
Third Party. The foregoing shall include, without limitation, RMS’ and/or its Affiliates’ rights to
independently develop, utilize, or commercialize the EGFR Assay and/or IVD and other diagnostic
tests (including in vitro diagnostic products or companion diagnostic products), whether alone or
in collaboration with Third Parties, for use either alone or in conjunction with the development or
commercialization of any pharmaceutical products other than the Clovis Oncology Compound.

8. INTELLECTUAL PROPERTY.

     8.1. Ownership of Background IP. Each Party and/or their Affiliates own all rights, title,
and interest in and to its respective Background IP. The Parties acknowledge and agree that, except
for the license expressly set forth in Section 7 above, neither Party shall have any rights to, or
licenses under, the other Party’s Background IP.

     8.2. Ownership of Project Results. Clovis Oncology and RMS shall have joint ownership of all
Project Results and each Party agrees to grant, and hereby grants, to the other Party an equal,
undivided interest in and to the Project Results.

     8.3. Ownership of Inventions. The Parties shall promptly notify each other in confidence of
any Inventions. Ownership of Inventions shall be determined by the following provisions:

          8.3.1. Clovis Oncology shall own all Inventions (regardless of inventorship) that relate
solely to the Clovis Oncology Compound (“Clovis Oncology Inventions”). RMS shall own all Inventions
(regardless of inventorship) relating solely to the EGFR Assay and the Diagnostic Field (“RMS
Inventions”); and

          8.3.2. Subject to Section 7.5, all other Inventions (regardless of inventorship) shall be
jointly owned by the Parties (“Joint Inventions”).

          8.3.3. Where applicable under Sections 8.3.1 and 8.3.2, the Parties agree to and do hereby
assign any and all right, title, and interest in such Inventions to the other Party. The Parties
agree (and agree to cause their Affiliates), upon request by the other Party and at the other
Party’s cost and expense, to promptly execute any and all documents deemed necessary or

Page 20 of 35

 

appropriate by the other Party (and/or their Affiliates) to memorialize, effect or perfect the
assignments under this Section 8.3.3 throughout the world. Clovis Oncology shall be responsible for
the prosecution and maintenance of any Patent applications and Patents claiming or covering any
Clovis Oncology Inventions, and RMS shall be responsible for the prosecution and maintenance of any
Patent applications and Patents claiming or covering any RMS Inventions and any Joint Inventions
(the “Joint Patents”), and Clovis Oncology shall (and shall cause its Affiliates to) reasonably
cooperate with RMS in connection with the same, including without limitation, upon the request of
RMS, promptly executing any and all Patent applications, formal documents, assignments, or other
instruments which RMS deems necessary or reasonably useful for the filing, prosecution,
maintenance, enforcement and/or defense of any Patent applications or Patents claiming or covering
any such Inventions, which may be filed or prepared at RMS’ cost and expense. RMS shall keep Clovis
Oncology reasonably informed of prosecution activities with respect to the Patent applications for
Joint Patents. RMS shall provide Clovis Oncology with a copy of material communications from any
patent authority regarding such Joint Inventions, and shall provide drafts of any material filings
or responses to be made to such patent authorities a reasonable amount of time in advance of
submitting such filings or responses so that Clovis Oncology may have an opportunity to review and
comment. If RMS abandons, ceases prosecution or does not maintain any Joint Patent anywhere in the
world, then RMS shall provide Clovis Oncology written notice of at least thirty (30) calendar days
prior to any deadline for taking action to avoid abandonment (or other loss of rights) and Clovis
Oncology shall have the right, in Clovis Oncology’s sole discretion, to file for or continue
prosecution and/or maintenance of such Joint Patent at its own expense. If Clovis Oncology elects
to assume responsibility for the filing, prosecution and/or maintenance of a Joint Patent abandoned
by RMS, then upon Clovis Oncology’s request, RMS shall assign to Clovis Oncology all of RMS’ right,
title and interest in and to such Joint Patent, and shall execute such documents necessary to
evidence such assignment.

     8.4. Third Party Contractors. To the extent that a Party utilizes Third Party contractors to
perform activities within the scope of the Project Plan, such Party shall ensure that such Third
Party contractors are obligated to assign rights to any Inventions and/or Project Results that are
made by such Third Party contractors so that such rights can be conveyed in accordance with the
terms and conditions of Sections 8.2 and 8.3.3.

     8.5. Defense and Enforcement. Each Party shall promptly notify the other Party in the event
it becomes aware of any Third Party activities that may constitute infringement of any Patents or
misappropriation and/or misuse of any Know-How that are subject to this Agreement, and/or of any
Third Party claims or allegations contesting the validity and/or enforceability of any such
Patents. With respect to any Joint Patents, the Parties will promptly thereafter consult and
cooperate to determine a course of action, which may include, without limitation, the commencement
of legal action by either or both of Clovis Oncology and RMS, to terminate or otherwise address
such infringement, misappropriation or misuse, and/or to defend the Joint Patents. Responsibility
and control over any actions to defend and/or enforce Patents under this Agreement shall be
allocated between the Parties in accordance with the terms of this Section 8.5.

          8.5.1. Background Patents and Patents Claiming Inventions. RMS shall have the right, but no
obligation, to control, enforce, and defend worldwide, at its own expense,

Page 21 of 35

 

the RMS Background Patents and any Patents claiming RMS Inventions. Clovis Oncology shall have
the right, but no obligation, to control, enforce, and defend worldwide, at its own expense, the
Clovis Oncology Background Patents and any Patents claiming Clovis Oncology Inventions.

          8.5.2. Responsibility for Joint Patents. Clovis Oncology and RMS are entitled, but have no
obligation, to control any legal proceedings or other actions to enforce and/or defend the Joint
Patents worldwide, at the expense of the Party that desires to control, enforce or defend (the
“Acting Party”). If both Parties desire to be the Acting Party, the Parties shall negotiate in good
faith about who should be in control. The Party that is not controlling, enforcing or defending the
applicable Joint Patent(s) (“Supporting Party”) is entitled, at its own expense, to be represented
in any such enforcement or defense by counsel of its own choice. If the Acting Party is unable to
initiate or prosecute the action solely in its own name, the Supporting Party will, upon request,
join the action and/or execute all documents reasonably necessary for the Acting Party to initiate,
prosecute and maintain the action. The Supporting Party shall have the right to consult with the
Acting Party to participate in decisions regarding the appropriate course of conduct for such
action, and the additional right to join and participate in (but not control) such action. A Party
shall have the right to be represented by legal counsel of its own choice in connection with any
legal proceedings or other actions undertaken by the other Party pursuant to this Section 8.5 to
defend or enforce the Joint Patents.

          8.5.3. Cooperation. The Supporting Party shall, upon request, reasonably assist and cooperate
with the efforts of the Acting Party. The Acting Party shall keep the Supporting Party informed of
any developments in the action.

          8.5.4. Settlements. The Acting Party shall have the right to settle the relevant claim or
actions; provided, however, that the Acting Party shall not, without the prior written consent of
the Supporting Party, enter into any settlement, consent judgment or other voluntary final
disposition of any claim or action that would: (i) subject the Supporting Party or its Affiliates
to an injunction or otherwise adversely impact any of the Supporting Party’s rights under this
Agreement; (ii) impose any financial obligation upon the Supporting Party or its Affiliates; and/or
(iii) constitute an admission of guilt or wrongdoing by the Supporting Party or its Affiliates.

          8.5.5. Recoveries. Any recovery of damages or other compensation received by a Party in
connection with a claim or action involving the Joint Patents will be first applied towards the
reimbursement of the Parties’ documented out-of-pocket costs and expenses associated with such
claim (including reasonable attorneys’ fees, expert witness fees, court costs and other litigation
costs and expenses). Any and all remaining amounts will then be allocated between the Parties on a
pro rata basis as determined based upon the relative economic losses suffered by each Party.

     8.6. Patent Term Restoration. The Parties agree to cooperate and to take reasonable actions
to maximize the protections available under the safe harbor provisions of 35 U.S.C. 103(c) for
United States patents and patent applications. The Parties shall cooperate with each other,
including without limitation to provide necessary information and assistance as the other Party may
reasonably request, in obtaining patent term restoration or supplemental protection certificates or
their equivalents in any country in the Territory where applicable to the Joint

Page 22 of 35

 

Patents and any other Patents claiming Inventions. In the event that elections with respect to
obtaining such patent term restoration are to be made, Clovis Oncology shall have the right to make
the election and RMS agrees to abide by such election.

9. COMPLIANCE.

     9.1. Debarment. Each Party hereby certifies (on behalf of itself and its Affiliates) that it
will not and has not employed or otherwise used in any capacity the services of any person debarred
under Title 21 United States Code Section 335a in performing any activities under this Agreement.
Each Party shall immediately notify the other Party in writing if any such debarment occurs or
comes to its attention, and shall, with respect to any person or entity so debarred promptly remove
such person or entity from performing any activities related to or in connection with the Project
Plan or this Agreement. Clovis Oncology shall have the right, in its sole discretion, to terminate
this Agreement immediately in the event of any such debarment involving RMS.

10. REPRESENTATIONS AND WARRANTIES

     10.1. Representations. Each Party hereby represents and warrants to the other Party as of the
Effective Date that: (i) it is a corporation duly organized, validly existing, and in good standing
under applicable laws; (ii) it has obtained all necessary consents, approvals and authorizations of
all governmental authorities and other persons or entities required to be obtained by it in
connection with this Agreement; (iii) the execution, delivery and performance of this Agreement
have been duly authorized by all necessary corporate action on its part; and (iv) it has the right
to grant the applicable rights and licenses provided for under this Agreement. Each of RMS and
Clovis Oncology further hereby represents, warrants and covenants to the other Party that during
the Term it will not grant or convey to any Third Party any right, license or interest in any
Patents or Know-How that is inconsistent with the rights and licenses expressly granted to the
other Party under this Agreement.

     10.2. Disclaimers. EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY
MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE PATENTS, KNOW-HOW, MATERIALS,
SAMPLES, EGFR ASSAY OR IVD, CLOVIS ONCOLOGY COMPOUND OR CONFIDENTIAL INFORMATION THAT IS LICENSED,
SUPPLIED OR OTHERWISE MADE AVAILABLE BY IT TO THE OTHER PARTY UNDER THIS AGREEMENT (INCLUDING
WITHOUT LIMITATION ANY WARRANTIES OF PATENT VALIDITY, ENFORCEABILITY AND/OR NONINFRINGEMENT), AND
EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.

     10.3. Limitation of Damages. NEITHER PARTY WILL BE LIABLE TO THE OTHER FOR ANY INDIRECT,
INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR OTHER SIMILAR DAMAGES (INCLUDING,
WITHOUT LIMITATION ANY CLAIMS FOR LOST PROFITS OR REVENUES) ARISING FROM OR

Page 23 of 35

 

RELATING TO THIS AGREEMENT OR PERFORMANCE UNDER, AND REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.

11. CONFIDENTIALITY.

     11.1. Obligation. RMS agrees to keep confidential and not to use, except for the purpose of
conducting the Project, any Confidential Information of Clovis Oncology or its Affiliates. RMS
further agrees to limit access to the Confidential Information of Clovis Oncology or its Affiliates
to those employees, Affiliates of RMS, agents, and contractors who require access in order to
perform the Project and who have previously agreed in writing, either as a condition to employment
or in order to obtain or access the Confidential Information of Clovis Oncology or its Affiliates,
to be bound by terms and conditions of confidentiality and non-use at least as stringent as the
terms of this Agreement. Clovis Oncology agrees to keep confidential and not to use, except for the
purpose of performing its obligations, and/or exercising any rights granted to it, under this
Agreement, Confidential Information of RMS or its Affiliates. Clovis Oncology further agrees to
limit access to the Confidential Information of RMS or its Affiliates to those employees,
Affiliates of Clovis Oncology, agents, and contractors who require access in order to perform the
Project and who have previously agreed in writing, either as a condition to employment or in order
to obtain or access the Confidential Information of RMS or its Affiliates, to be bound by terms and
conditions of confidentiality and non-use at least as stringent as the terms of this Agreement. The
obligations of confidentiality and non-use in this Article 11 shall continue during the Term of
this Agreement and *** after the Term expires. These obligations of confidentiality and non-use
shall not apply to Confidential Information of the other Party or their Affiliates which (i) is
publicly available by use and/or publication before its receipt from the respective Party or its
Affiliates, or on their behalf, or its development under the Project, or thereafter become publicly
available through no fault of the Party; (ii) were already in a Party’s possession prior to receipt
from the other Party or an Affiliate of such Party or on their behalf or its development under the
Project, as evidenced by records kept by the Party in the ordinary course of business; or (iii) are
properly obtained by a Party from a Third Party which has a valid right to disclose such
information to the Party, is not under a confidentiality obligation to the other Party or an
Affiliate, and is not disclosing such information to the Party on behalf of the other Party or an
Affiliate.

     11.2. Project Results. Project Results shall be Confidential Information of both Parties,
except that Clovis Oncology shall have the right to use and disclose Project Results to any
Affiliate or Third Party in the Pharmaceutical Field and RMS shall have the right to use and
disclose Project Results to any Affiliate or Third Party in the Diagnostics Field.

     11.3. Exceptions. Notwithstanding the obligations of confidentiality and non-use set forth in
Section 11.1 above, either Party shall be permitted to disclose Confidential Information of the
other Party that is required to be disclosed to comply with applicable laws, court order, or
governmental regulations, provided that such Party provides prior written notice of such disclosure
to the other Party and takes reasonable and lawful actions to avoid and/or minimize the degree of
such disclosure. The prior written notice must be given as soon as reasonably possible in order to
permit a Party to challenge such disclosure or to seek a protective order or some other
accommodation to protect the confidentiality of the information that is required to be disclosed.

Page 24 of 35

 

     11.4. No License. Disclosure of Confidential Information by one Party to the other Party
pursuant to this Agreement does not convey, grant, transfer or otherwise create any option, license
or other rights or interests beyond those licenses expressly granted in this Agreement.

12. PUBLICITY AND PUBLICATION.

     12.1. Publicity. The Parties will agree upon an initial form of press release regarding their
execution and entering into this Agreement, and which is intended to be issued on or promptly after
the Effective Date as mutually agreed to by the Parties. Neither Party may issue any other press
release or other public statement or announcement concerning this Agreement, the subject matter
hereof, or the research, development or commercial results of the products hereunder without the
other Party’s prior written consent. In addition, neither Party shall make any disclosure of this
Agreement and/or the terms and conditions set forth herein, or use the name or any trademarks,
logos or trade dress of the other Party or its Affiliates in any publicity, press release or other
form of public announcement or disclosure without the prior written consent of the other Party.

     12.2. Publication. The Parties shall have the right to publish, present or use the Project
Results or any portion thereof for their instructional, or publication objectives, or for
non-confidential discussions with a Third Party, except that Clovis Oncology shall not have the
right to publish, present or use the Project Results or any portion thereof for their
instructional, or publication objectives, or for non-confidential discussions with a Third Party in
the Diagnostics Field, and RMS shall not have the right to publish, present or use the Project
Results or any portion thereof for their instructional, or publication objectives, or for
non-confidential discussions with a Third Party in the Pharmaceutical Field (individually, a
“Publication”). Such Publication shall be subject to the provisions of this Agreement relating to
confidentiality and non-disclosure, and shall be consistent with
academic standards. At least *** days prior to submission for publication,
or *** days prior to
submission for presentation or use (including abstracts), the publishing Party shall submit to the
other Party for review any proposed Publication. The other Party shall review the proposed
Publication and provide its comments to the publishing Party no later than five (5) calendar days
prior to the proposed submission date for the Publication. Upon the other Party’s notice to the
publishing Party that the other Party reasonably believes that one or more patent applications
should be filed which relate to Inventions owned by the other Party or Joint Inventions prior to
any Publication, the publishing Party shall delay the Publication until such patent application(s)
have been filed, provided that the other Party will cooperate in expeditiously filing any such
patent application(s), and provided further that any such delay of a Publication will not exceed
one hundred and eighty (180) calendar days from the date of such notice by the other Party to the
publishing Party. If the other Party believes that any Publication contains confidential or
proprietary information belonging to the other Party, the other Party will notify the publishing
Party, which will remove all references to such confidential or proprietary information prior to
publication, presentation or use.

Page 25 of 35

 

13. TERM AND TERMINATION.

     13.1. Term of Agreement. The term of this Agreement (the “Term”) commences on the Effective
Date and shall continue for a indefinite period of time until terminated in accordance with
Sections 13.2, to 13.7 below.

     13.2. Termination by the Parties before the Stage Start Date of the first Stage.

          13.2.1. Clovis Oncology may terminate this Agreement with immediate effect before the Stage
Start Date of the first Stage by giving written notice to RMS. RMS may terminate this Agreement
with immediate effect before the Stage Start Date of the first Stage by giving written notice to
Clovis Oncology in the event of any circumstances outside of the control of RMS which are foreseen
by RMS to have a material impact on the Project, such as a material increase of the Budget or a
material extension of the timelines.

     13.3. Termination by Clovis Oncology after the Stage Start Date of the first Stage.

          13.3.1. Termination by Clovis Oncology. Clovis Oncology may terminate this Agreement at any
time after the Stage Start Date of the first Stage by providing RMS *** days prior written notice to that effect. In such event, *** day period, the Parties
will agree upon and conduct an orderly wind down of any ongoing activities being performed under

          13.3.2. Consequences of Termination.
 If Clovis Oncology terminates this Agreement pursuant to Section 13.3.1 for
reasons other than (i) termination of the development of the Clovis Oncology Compound, (ii) the FDA not requiring a
companion diagnostic for the Clovis Oncology Compound, or (iii) RMS being unable, despite its use of commercially
reasonable efforts, to develop the EGFR Assay or IVD that satisfies the Specifications, then Clovis Oncology shall reimburse
RMS ***. Such amount shall take into consideration any amounts owed between the Parties according to Section 6.2.

     13.4. Termination by RMS after the Start of the first Stage. RMS may not terminate this
Agreement after the Stage Start Date of the first Stage, except (i) in accordance with Sections
13.5, 13.6 and 13.7, and (ii) if RMS is unable, despite its use of commercially reasonable efforts,
to develop the EGFR Assay or IVD that satisfies the Specifications, in which case RMS shall notify
Clovis Oncology thereof in writing. If within *** days from the receipt of such
notice by Clovis Oncology the Parties are unable or unwilling to agree on Specifications that RMS
believes to be able, using commercially reasonable efforts, to satisfy then RMS may terminate the
Agreement by providing Clovis Oncology with *** days  prior written notice. In such
event, *** day period, the Parties will agree upon and conduct an orderly wind
down of any ongoing activities being performed under the Project Plan.

     13.5. Termination by Mutual Agreement. This Agreement may be terminated at any time by mutual
written agreement of the Parties.

Page 26 of 35

 

     13.6. Termination for Breach. A Party shall have the right to terminate this Agreement in the
event that the other Party is in breach of one or more of its material obligations under this
Agreement, by providing the breaching Party written notice describing the breach. If the breaching
Party has not cured such breach within sixty (60) calendar days after receipt of such notice, then
termination of the Agreement shall be effective immediately upon expiration of such period.

     13.7. Termination for Insolvency or Bankruptcy. Either Party may terminate this Agreement
effective on written notice to the other Party upon the liquidation, dissolution, winding-up,
insolvency, bankruptcy, or filing of any petition therefore, appointment of a receiver, custodian
or trustee, or any other similar proceeding, by or of the other Party where such petition,
assignment or similar proceeding is not dismissed or vacated within ninety (90) calendar days. All
rights and licenses granted pursuant to this Agreement are, for purposes of Section 365(n) of Title
11 of the United States Code or any foreign equivalents thereof (as used in this Section 13.7,
“Title 11”), licenses of rights to “intellectual property” as defined in Title 11. Each Party in
its capacity as a licensor hereunder agrees that, in the event of the commencement of bankruptcy
proceedings by or against such bankrupt Party under Title 11: (i) the other Party, in its capacity
as a licensee of rights under this Agreement, retains and may fully exercise all of such licensed
rights under this Agreement, including as provided in this Section 13.7, and all of its rights and
elections under Title 11; and (ii) the other Party is entitled to a complete duplicate of all
embodiments of such intellectual property, and such embodiments, if not already in its possession,
will be promptly delivered to the other Party: (1) upon any such commencement of a bankruptcy
proceeding, unless the bankrupt Party elects to continue to perform all of its obligations under
this Agreement; or (2) if not delivered under (1), immediately upon the rejection of this Agreement
by or on behalf of the bankrupt Party.

     13.8. Effects of Termination. The expiration or earlier termination of this Agreement, for
any reason, shall not affect any rights or obligations that have already accrued as of the date of
such expiration or termination, nor preclude either Party from pursuing any rights and remedies it
may have under this Agreement or at law or in equity which accrued or are based upon any event
occurring before expiration or termination. If this Agreement is terminated by either Party for any
reason after the first commercial sale of the EGFR Assay or IVD in any country of the Territory,
the licenses granted in Section 7 shall survive such termination.

     13.9. Disposition of Confidential Information. Upon termination of this Agreement, each Party
shall, except to the extent necessary or appropriate under any licenses which survive such
termination, promptly return (or destroy and provide written certification thereof) to the other
Party all of the other Party’s Confidential Information (including any copies thereof).

     13.10. Survival. In addition to any provisions specified in this Agreement as surviving under
the applicable circumstances, the provisions of Articles 6, 8, 11, 12, 14 and 15, and Sections 4.4,
7.5, 7.6, 7.9, 10.2, 10.3, 13.3.2, 13.8, 13.9 and 13.10 of this Agreement and the definition for
any defined terms contained within this Agreement survive expiration or termination of this
Agreement.

Page 27 of 35

 

14. DISPUTE RESOLUTION

     14.1. Arbitration. Except as otherwise expressly provided in this Agreement, any dispute or
disagreement between the Parties arising in connection with this Agreement and/or their performance
hereunder will be finally resolved through binding arbitration. The arbitration shall be conducted
pursuant to the Commercial Arbitration Rules and Supplementary Procedures for Large Complex
Disputes of the American Arbitration Association (“AAA”) and the provisions of this Article 14.

     14.2. Arbitration Panel. The arbitration shall be conducted by a panel of three (3)
arbitrators. Within thirty (30) calendar days after the initiation of the arbitration, each Party
will nominate one person to act as an arbitrator, and the two arbitrators so named will then
jointly appoint the third arbitrator within thirty (30) calendar days of their appointment, who
will serve as chairman of the arbitration panel. All three (3) arbitrators must be independent
Third Parties having at least ten (10) years of dispute resolution experience (including judicial
experience) and/or legal or business experience in the biotech or pharmaceutical industry. If any
Party fails to timely nominate its arbitrator, or if the arbitrators selected by the Parties cannot
agree on the person to be named as chairman within such thirty (30) day period, the AAA will make
the necessary appointments for such arbitrator(s) or the chairman. Once appointed by a Party, such
Party will have no ex parte communication with its appointed arbitrator.

     14.3. Location and Proceedings. The place of arbitration will be San Francisco, CA or such
other venue as the Parties may mutually agree. The arbitration proceedings and all communications
with respect thereto will be in English. Any written evidence originally in another language will
be submitted in English translation accompanied by the original or a true copy thereof. The
arbitrators have the power to decide all matters in dispute, including any questions of whether or
not such matters are subject to arbitration hereunder. The decisions of the arbitrators shall be
final and binding on the Parties and shall not be subject to appeal

     14.4. Limitation on Awards. The arbitrators shall have no authority to award any punitive,
exemplary, consequential, indirect, special or other similar damages. Each Party shall bear its own
costs and expenses (including without limitation attorneys’ fees and expert or consulting fees)
incurred in connection with the arbitration. The Parties shall equally (50:50) share the
arbitrator’s fees and any other administrative costs and expenses associated with the arbitration.

     14.5. Confidentiality. Neither Party, nor any of the arbitrators, shall be permitted to
disclose the existence, content or results of any arbitration proceedings pursuant to this Article
14, without the prior written consent of both Parties.

     14.6. Equitable Remedies. Notwithstanding anything in this Agreement to the contrary, either
Party shall have the right to seek a temporary injunction or other interim equitable relief from a
court of competent jurisdiction in order to protect its rights and interests under this Agreement
pending the outcome of any arbitration hereunder. However, such court will have no jurisdiction or
ability to resolve disputes beyond the specific issue of temporary injunction or other interim
equitable relief.

Page 28 of 35

 

     14.7. Continued Performance During Dispute. During the pendency of any arbitration
proceedings under this Article 14, the Parties will continue using commercially reasonable efforts
to perform their respective obligations under the Agreement and in accordance with its provisions
in a manner which to the fullest extent practicable will maintain the status quo of the Parties
with respect to those matters which are the subject to the dispute.

15. MISCELLANEOUS

     15.1. Governing Law. This Agreement shall be construed in accordance with the laws of the
State of Delaware, without regard or reference to any of its rules or provisions governing conflict
of laws.

     15.2. Independent Contractors. Nothing in this Agreement is intended or will be deemed to
constitute a partnership, agency, distributorship, employer-employee relationship or joint venture
relationship between the Parties. No Party is permitted or shall have any authority to bind or make
any commitments for or on behalf of the other Party, except to the extent expressly provided in
this Agreement or the Project Plan.

     15.3. Performance by Affiliates. Each Party is responsible for its Affiliates performance of
any activities under this Agreement, and will cause its Affiliates to comply with the provisions of
this Agreement in connection with such performance.

     15.4. No Strict Construction; Headings. This Agreement has been prepared jointly and will not
be strictly construed against either Party. Ambiguities, if any, in this Agreement will not be
construed against any Party, irrespective of which Party may be deemed to have authored the
ambiguous provision. The headings of each Article and Section in this Agreement have been inserted
for convenience of reference only and are not intended to limit or expand the meaning of the
language contained in the Article or Section.

     15.5. Assignment. Neither Party is permitted to assign its interest under this Agreement
without the express prior written consent of the other Party; provided, however, that a Party may
assign this Agreement without such consent (i) to an Affiliate, or (ii) to any purchaser of all or
substantially all of the assets of such Party or to any successor corporation or entity (whether by
way of merger, acquisition or otherwise), so long as the entity to which this Agreement is assigned
expressly agrees in writing to assume and be bound by all obligations of the assigning Party under
this Agreement. Any purported assignment without a required consent is null and void. No assignment
will relieve any Party of responsibility for the performance of any obligation that accrued before
the effective date of assignment. This Agreement is binding upon the permitted successors and
assigns of the Parties

     15.6. Further Actions. Each Party will execute, acknowledge and deliver such further
instruments, and do all such other acts, as may be necessary or appropriate in order to carry out
the purposes and intent of this Agreement.

     15.7. Notices and Deliveries. Any notices required or provided by the terms of this Agreement
shall be in writing, addressed in accordance with this Section, and shall be delivered, except as
otherwise indicated below, personally or sent by certified or registered mail, return

Page 29 of 35

 

receipt requested, postage prepaid, or by nationally-recognized express courier services providing
evidence of delivery. Except as noted below, the effective date of any notice shall be the date of
first receipt by the receiving Party. Notices shall be sent to the address(es)/addressee(s) given
below or to such other address(es)/addressee(s) as the Party to whom notice is to be given may have
provided to the other Party in writing in accordance with this provision.

	 	 	 
	If to Clovis Oncology:

	 	Clovis Oncology, Inc.
	 

	 	2525 28th Street, Suite 100
	 

	 	Boulder, CO 80301
	Submit invoices to:

	 	Attention: Accounts Payable
	 
	 	 
	If to RMS:
	 	 
	(Technical contact)

	 	RMS Molecular Systems, Inc.
	 

	 	4300 Hacienda Drive
	 

	 	Pleasanton, CA 94588
	 

	 	Attention: Genomics and Oncology Lifecycle Team Leader
	 
	 	 
	(Administrative contact)

	 	RMS Molecular Systems, Inc.
	 

	 	4300 Hacienda Drive
	 

	 	Pleasanton, CA 94588
	 

	 	Attention: Legal Department
	 
	 	 
	With a copy to:

	 	RMS Molecular Systems, Inc.
	 

	 	4300 Hacienda Drive
	 

	 	Pleasanton, CA 94588
	 

	 	Attention: Business Development

     15.8. Force Majeure. Neither Party will lose any rights hereunder or be liable to the other
Party for damages or losses (except for payment obligations) on account of failure of performance
by the nonperforming Party if the failure is occasioned by war, strike, fire, Act of God,
earthquake, flood, lockout, embargo, governmental acts or orders or restrictions, failure of
suppliers, prevention from or hindrance in obtaining energy or other utilities, a market shortage
of raw materials or necessary components, contamination of the facility that was used for the
clinical or commercial manufacture of the EGFR Assay, IVD or Clovis Oncology Compound, or any other
reason where failure to perform is beyond the reasonable control and not caused by the negligence,
intentional conduct or misconduct of the nonperforming Party and the nonperforming Party has
exerted all reasonable efforts to avoid or remedy such force majeure; but, in no event will a Party
be required to settle any labor dispute or disturbance.

     15.9. Severability; Waiver. If any one or more of the provisions of this Agreement should for
any reason be held by any court or authority having jurisdiction over this Agreement or either of
the Parties to be invalid, illegal or unenforceable, such provision or provisions will be validly
reformed to as nearly as possible approximate the intent of the Parties and, if it cannot be

Page 30 of 35

 

reformed, will be divisible and deleted. Any delay in enforcing a Party’s rights under this
Agreement or any waiver as to a particular default or other matter will not constitute a waiver of
such Party’s rights to the future enforcement of its rights under this Agreement, except with
respect to an express written and signed waiver relating to a particular matter for a particular
period of time.

     15.10. Entire Agreement; Modification. This Agreement, together with any Attachments attached
hereto and specifically referenced herein, constitutes the entire agreement between the Parties
with respect to the Project and supersedes and replaces any and all previous arrangements and
understandings, whether oral or written, between the Parties with respect to the Project, provided,
however, that *** (ii) the CDA
shall survive and remain in effect for proprietary information of Clovis Oncology that falls
outside the scope of Section 11 of this Agreement. Any amendment or modification to this Agreement
shall be of no effect unless made in a writing signed by an authorized representative of each
Party. If there is a conflict between the terms of this Agreement and any Attachments hereto, the
terms of this Agreement shall prevail.

     15.11. Counterparts. This Agreement may be signed in any number of counterparts (facsimile
and electronic transmission included), each of which shall be deemed an original, but all of which
shall constitute one and the same instrument. After facsimile or electronic transmission, the
Parties agree to execute and exchange documents with original signatures.

[Remainder of this page is left intentionally blank]

Page 31 of 35

 

IN WITNESS WHEREOF, RMS and Clovis Oncology, intending to be legally bound, have executed this
Agreement as of the Effective Date by their respective duly authorized representatives.

	 	 	 	 	 

	CLOVIS ONCOLOGY, INC.	 	 
	 
	 	 	 	 
	By:

	 	/s/ Patrick J. Mahaffy
 

	 	 
	 
	 	 	 	 
	Name:

	 	Patrick J. Mahaffy
 

	 	 
	 
	 	 	 	 
	Title:

	 	President & CEO
 

	 	 
	 
	 	 	 	 
	ROCHE MOLECULAR SYSTEMS, INC.	 	 
	 
	 	 	 	 
	By:

	 	/s/ P. A. Brown
 

	 	 
	 
	 	 	 	 
	Name:

	 	P.A. Brown
 

	 	 
	 
	 	 	 	 
	Title:

	 	President & CEO RMS
 

19 April 2011
	 	 

Page 32 of 35

 

EXHIBIT A

Preliminary Project Plan

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Stage	 	Timeline	 	State 

Budget ($M)	 	Deliverable	 	Payment Schedule
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Initiation Intermediate Completion

          ***

Page 33 of 35

 

          ***

Page 34 of 35

 

EXHIBIT B

Minimum Requirements for Stage Plans

			
	1.	 	Background

			
	2.	 	Work Plan definitions

			
	3.	 	Purpose

			
	4.	 	Deliverables

			
	5.	 	Clovis Oncology Deliverables

			
	6.	 	RMS Deliverables

			
	7.	 	Budget

			
	8.	 	Assumptions (such as timelines, Specification of the Assay, number of samples tested
etc.)

Page 35 of 35exv10w28

Exhibit 10.28

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

MASTER SERVICE AGREEMENT

     This Master Service Agreement (this “Agreement”) is effective March 23, 2010, (the “Effective
Date”), between Ventana Medical Systems, Inc., 1910 E. Innovation Park Drive, Tucson, AZ 85755
United States (“Ventana”), and Clovis Oncology, Inc., 2525 28th Street, Suite 180,
Boulder, CO 80301 (“Clovis”).

     WHEREAS, Clovis researches, develops, manufactures, markets and sells pharmaceutical products;

     WHEREAS, Ventana is engaged in business supplying services in relation to the pharmaceutical
industry and related industries including providing laboratory services; and

     WHEREAS, Clovis wishes to engage the Ventana in relation to one or more projects to provide
services in relation to laboratory services, development, validation, clinical studies or related
projects and Ventana agrees to accept the engagement on the following terms and conditions.

     Now, Therefore, the Parties agree as follows:

1. Definitions and Interpretations

     In this Agreement the following expressions shall have the following meanings:

     1.1 “Confidential Information” shall mean any confidential or proprietary information of a
Party, Data (as defined in Section 7.2) and any other information relating to any compound,
research project, work in process, future development, scientific, engineering, manufacturing,
marketing, business plan, financial or personnel matter relating to such Party, its present or
future products, sales, suppliers, customers, employees, investors or business, whether in oral,
written, graphic or electronic form.

     1.2 “Party” shall mean Clovis or Ventana as the context requires, and “Parties” shall mean
both Clovis and Ventana;

     1.3 “Project” shall mean the project or projects to be undertaken under this Agreement as
described in each Schedule (as amended from time to time and by written agreement of the Parties):

     14 “Services” means the work to be performed and services to be provided by Ventana in
relation to each Project pursuant to this Agreement as set out in the relevant Schedule, as amended
from time to time, and such other services in relation to each Project as may from time to time be
agreed upon by the Parties in writing.

2. Services

     This Agreement governs the Services for all Projects and Services at the times and locations
specified in the Schedule in relation to each Project. All such Services and Projects will be
subject to all of the terms and conditions contained in this Agreement unless otherwise mutually
agreed in writing between the Parties. Ventana shall provide the Services in accordance with the
relevant Schedule and to the best of its ability and with the standards of care and skill to be
reasonably expected in the field of providing services in the nature of the Services.

3. Additional Services

     3.1 The specific details of Services to be provided by Ventana within each Project under this
Agreement will be separately negotiated and specified in writing in a Schedule to be agreed upon
and executed by the Parties. Each Schedule will describe the scope of work and Project time line and compensation terms. Once executed by both Parties, Schedules become
part of this Agreement and are incorporated in this Agreement in their entirety. Each time that
the

Clovis MSA 3-17-10

 

 

Parties agree that a new project should be added to and come within the scope of this
Agreement, the Parties shall prepare a Schedule for such project.

     3.2 Each time that the Parties agree that additional services should be added to and come
within the scope of a Project under this Agreement, or that the Services should be amended, the
Parties shall prepare a revised version of the Schedule relevant to such Project. The revised
Schedule shall have added to it a description of such new or amended Services, provisions regarding
the financial consideration in relation to such new or amended Services and other necessary details
regarding the provision of such new or amended Services.

     3.3 Terms or conditions on a Schedule that differ from those in this Agreement take precedence
over the terms and conditions in the Agreement only with respect to Services under that particular
Schedule, and only where the Schedule explicitly identifies those terms and conditions in the
Agreement that are intended to be superseded or modified.

4. Payment

     4.1 Fees and Invoices. In consideration for the Services to be performed by Ventana, Clovis
shall pay Ventana in accordance with the Fee/Payment provisions set forth in the applicable
Schedule. Following the end of each calendar month Ventana shall submit to Clovis an invoice for
the fees payable in respect of that month. Clovis shall pay such invoices within thirty (30) days.

     4.2 Reimbursable Expenses. In addition to the fees payable under Section 4.1, Clovis will
reimburse all reasonable out of pocket travel expenses validly incurred by Ventana in performing
the Services as is authorized in the relevant Schedule. Such expenses include but are not limited
to those specified in the relevant Schedule, but which are incidental to the required travel, such
as transportation, lodging and meals.

5. Material Transfer

     5.1 The Material. “Material” shall mean the biological samples, compounds, reagents,
supplies, products and other goods that Clovis delivers, or causes to be delivered, to Ventana
pursuant to this Agreement. If after Clovis provides the Material, the Parties together determine
that they do not conform to their descriptions or otherwise are not suitable for the work under the
Schedule, then Clovis will (i) provide new or replacement Material or, if that is not possible,
propose an alternative and pay any additional costs for Ventana to procure the alternative, and
(ii) subject to written agreement between the Parties, adjust the Schedule, fees and/or costs as
necessary to account for any delay caused by non-conforming Material. If the Parties are unable to
reach an agreement as to the suitability of the Material or suitable alternative, or if a suitable
alternative is not available upon terms agreeable to the Parties, then in that event, the
applicable Schedule shall automatically terminate and Clovis shall pay Ventana any costs and/or
fees for Services completed by Ventana at the time of termination for which payment remains
outstanding.

     5.2 Ventana shall handle the Material in accordance with any applicable documentation,
reasonable handling procedures for similar materials, and Clovis’s instructions. Ventana may use
the Material only for the Services for which the Material is provided and only in accordance with
the applicable Schedule. Ventana will use the Material solely for the Services described in the
applicable Schedule and for no other purpose. None of the Material will be transferred or sold to
third parties. Ventana will not use the Material for testing in or treatment of human subjects.
Subject to Section 8.4, any Material remaining upon completion of the Services or upon expiration
or termination of this Agreement will be returned to Clovis or destroyed, at Clovis’s option.

Clovis MSA 3-17-10

   

 

6. Confidentiality

     6.1 Both Parties hereby agree:

     6.1.1 not to use any Confidential Information of the other Party except for the
purpose of conducting the applicable Project and Services hereunder, or as otherwise
expressly authorized in writing by the other Party, and

     6.1.2 not to disclose or transfer any Confidential Information of the other Party, or
any materials which contain such Confidential Information, to any third party or entity
without the express prior written permission of disclosing Party, other than to receiving
Party’s employees or agents who require such Confidential Information for the purpose
hereof and who are bound by like written obligations of confidentiality and non-use with
respect to such Confidential Information.

6.2 The obligations set forth in Section 6.1 will not apply to any information that:

     6.2.1 the receiving Party can demonstrate can demonstrate was possessed prior to
disclosure or development under this Agreement or can demonstrate was developed
independently from disclosure or development under this Agreement;

     6.2.2 is publicly available at the time of receipt by the receiving Party or later
becomes publicly available other than by breach of this Agreement by receiving Party; or

     6.2.3 which becomes available to a Party from a third party which is not legally
prohibited from disclosing such information; or

     6.3 Either Party may disclose Confidential Information of the other Party to the extent
required to be disclosed by applicable judicial or governmental order, provided that the receiving
Party takes all reasonable steps to give the disclosing Party sufficient prior notice in order to
contest such order and, in the event the receiving Party is ultimately required to disclose such
Confidential Information, that the receiving Party discloses only such portion of such Confidential
Information as required to be disclosed and seeks a protective order to protect the confidentiality
of such Confidential Information.

     6.4 Each Party shall return Project-related Confidential Information of the other Party or
upon request destroy all such Confidential Information, at the completion or early termination of a
Project. A Party may retain one copy of Confidential Information of the other Party solely for the
purpose of determining future compliance with the terms of this Agreement.

     6.6 The obligations of each Party in this Article 6 shall in respect of Confidential
Information relating to each Project, survive for a period of *** years from the date of
completion or termination of such Project.

     6.7 Each of the Parties agrees that money damages may not be an adequate remedy for breach of
this Article 6 and that, accordingly, either Party shall be entitled to seek injunctive or other
equitable relief.

7. Intellectual Property

     7.1 Each Party acknowledges that the other Party owns or controls certain inventions,
processes, know-how, trade secrets, improvements and other intellectual property which have been
independently developed by each Party and which relate to that Party’s business or operations. It
is acknowledged that the intellectual property owned or controlled by either Party on the date of
this Agreement will remain the exclusive property of the owning or controlling Party, and except as
expressly provided in this Agreement, no right under the intellectual property of the

Clovis MSA 3-17-10

   

 

owning or controlling Party, by license or otherwise, is granted to the other Party by virtue of
this Agreement.

     7.2 All data and laboratory results directly related to a Project (“Data”) supplied to Ventana
by Clovis, or prepared or developed by Ventana in the course of
providing Services, shall be ***. Data shall be ***.

     7.3 The parties agree that, subject to clause 7.4 below, with respect to all inventions and
discoveries that are developed by a Party and are directly related to a Project, whether or not
patentable or copyrightable, and all intellectual property rights therein and thereto
(collectively, “Project Inventions”):

     7.3.1 Clovis shall exclusively own all right, title and interest, including, without
limitation, all intellectual property rights, in and to any Project Inventions that are
developed, created, discovered, conceived, or reduced to practice solely by employee(s)
and/or consultant(s) of Clovis, or by employee(s) and/or consultant(s) of Clovis and a
third party (“Clovis Project Inventions”).

     7.3.2 Ventana shall exclusively own all right, title and interest, including, without
limitation, all intellectual property rights, in and to the assays or diagnostics developed
by Ventana, and to any Project Invention created, discovered, conceived, or reduced to
practice solely by employee(s) and/or consultant(s) of Ventana, or by employee(s) and/or
consultant(s) of Ventana and a third party which do not incorporate Materials or
Confidential Information provided by Clovis (“Ventana Project
Inventions”). ***

     7.3.3 Clovis and Ventana shall each own an equal, undivided interest, including,
without limitation, all intellectual property rights, in and to any Project Inventions that
are developed, created, discovered, conceived, or reduced to practice jointly by
employee(s) and/or consultant(s) of Clovis and employee(s) and/or consultant(s) of Ventana
(hereinafter “Jointly-Owned Project Inventions”). ***

     7.4 Clovis acknowledges that Ventana possesses certain technical and conceptual expertise in
the areas including but not limited to, certain computer software programs for image analysis of
biological systems, immunohistochemistry, in situ hybridization, automated anatomic pathology
systems, certain assays, diagnostic assay development expertise, diagnostic test kits including
proprietary antibodies, statistical methodologies and other formulae and analytical techniques and
laboratory services (“Pre-existing Ventana Proprietary Information”) that have been independently
developed or obtained by Ventana prior to the date of this Agreement without the benefit of any
information or materials provided by Clovis, and such Pre-existing Ventana Proprietary Information
may be used by Ventana under or during the term of this Agreement in connection with Projects.
Such Pre-existing Ventana Proprietary Information is and shall remain Ventana’s exclusive property.
In addition, any improvements to Pre-existing Ventana Proprietary Information created by Ventana,
its employees or agents, shall be the sole property of Ventana, whether or not created during the
term of this Agreement or in connection with Projects; provided that such improvements do not rely
on or incorporate Materials or Confidential Information provided by Clovis hereunder.

Clovis MSA 3-17-10

 

 

If any Pre-existing Ventana Proprietary Information is required to make use of any deliverables
provided to Clovis by Ventana in connection with a Project, upon request by Clovis, Ventana agrees
to negotiate in good faith the terms of a non-exclusive reasonable commercial license to such
Pre-existing Ventana Proprietary Information for the sole purpose of making full use of the Project
deliverables for their intended purpose.

     7.5 In the event that Ventana develops a PMA hENT1 assay as a companion diagnostic to CO-1.01,
and obtains FDA Regulatory Approval, and subsequently declines, refuses or is unable to undertake
commercialization of the same, then in that event, Ventana shall enter into good faith negotiations
with Clovis, ***

8. Term and Termination

     8.1 This Agreement will commence on the Effective Date, and shall continue for a period of
three (3) years, or until terminated in accordance with clause 8.2 below. The obligations of the
Parties under this Agreement will survive the expiration or termination of this Agreement as
necessary to allow completion of a Project under an applicable Schedule that extends beyond this
Agreement’s expiration or termination.

     8.2 This Agreement or any particular Project (and its corresponding Schedule) may be
terminated by Clovis for any reason or no reason upon not less than
*** days prior written
notice. Ventana may also terminate this Agreement upon  *** prior notice. In addition,
Clovis or Ventana may terminate this Agreement or any Project immediately by written notice to
other party, in the event of a material breach of this Agreement or such Project by the other
Party, if the non-breaching Party shall have given written notice to the breaching Party specifying
the nature of the breach and such breach shall not have been
substantially cured within thirty (30) days after such notice of breach. Any termination by either Party for breach by the other Party
shall be without prejudice to any damages or remedies to which it may be entitled from the other
Party. Clovis or Ventana may terminate this Agreement or any Project immediately by written notice
to the other party, if the other Party becomes insolvent, makes or has made an assignment for the
benefit of creditors, is the subject of proceedings in voluntary or involuntary bankruptcy
instituted on behalf of or against it (except for involuntary bankruptcies which are dismissed
within ninety (90) days) or has a receiver or trustee appointed for substantially all of its
property.

     8.3 Upon receipt of a termination notice under Section 8.2, the Parties shall promptly meet to
prepare a close-out schedule, and Ventana shall cease performing all work not necessary for the
orderly close-out of the applicable Services or the affected Project(s) or for the fulfillment of
any regulatory requirements. Ventana shall *** conclude or transfer such
Project(s), *** in accordance with all
regulatory requirements. Clovis will pay Ventana any outstanding amounts due for Services
performed in accordance with the Schedule(s) covering the Project(s) affected by such termination.
Ventana will deliver to Clovis any Data or other deliverables to be provided by Ventana in
connection with any terminated Project as they may exist as of the date of termination, unless
otherwise agreed by the Parties. Clovis will pay for all actual, documented out-of-pocket
reasonably incurred by Ventana to complete activities associated with the close-out of affected
Project(s), including the fulfillment of any regulatory requirements (which will be billed
consistent with the corresponding Schedule or, to the extent not provided for in a Schedule, in
accordance with the budget in effect under the applicable Schedule as of the date of the
termination notice).

     ***

Clovis MSA
3-17-10

 

 

***

     8.5 The termination of this Agreement or any Project however arising, will be without
prejudice to the rights and duties of the parties accrued prior to such termination. Articles 5
-10 shall survive termination of this Agreement or of any Project for whatever reason. Termination
of this Agreement will not relieve either Party of any liability which accrued hereunder prior to
the effective date of such termination, nor preclude either Party from pursuing all rights and
remedies it may have hereunder at law or in equity with respect to any breach of this Agreement,
nor prejudice either Party’s right to obtain performance of any obligation.

9. Indemnification

     9.1 Ventana shall defend, indemnify and hold harmless Clovis, and its respective officers and
employees (each a “Clovis Indemnified Party”), from and against all losses, damages, liabilities,
settlements penalties, fines, costs and expenses (including reasonable attorney’s fees and
expenses) to the extent the foregoing arise out of or result from any claim, lawsuit or other
action or threat by a third party (each a “Liability”) arising out of any breach by Ventana of the
representations or warranties under this Agreement, ***, or of
Ventana’s ***, all save to the extent caused or contributed to by Clovis’s
***.

     9.2 Clovis shall defend, indemnify and hold harmless Ventana, and its respective officers and
employees (each a “Ventana Indemnified Party”), from and against all losses, damages, liabilities,
settlements penalties, fines, costs and expenses (including reasonable attorney’s fees and
expenses) to the extent the foregoing arise out of or result from any claim, lawsuit or other
action or threat by a third party (each a “Liability”) arising out of the use, manufacture, sale,
development or research by Clovis or its licensees or transferees of deliverables provided by
Ventana under this Agreement (including but not limited to drug-based product liability), all save
to the extent caused or contributed to by Ventana’s *** breach of its
obligations under this Agreement.

     9.3 Each Party’s agreement to indemnify, defend and hold the other harmless is conditioned on
the indemnified Party: (i) providing written notice to the indemnifying Party of any claim, demand,
cause of action or suit arising out of the indemnified activities within twenty (20) days after the
indemnified Party has knowledge of such claim, demand or action (except that the indemnifying Party
shall not be released from its indemnity obligation if the failure to notify the indemnifying Party
within twenty (20) days does not materially prejudice the defense of such claim or suit); (ii)
permitting the indemnifying Party to assume full responsibility to investigate, prepare for and
defend against any such claim, demand, causes of action or suit; (iii) assisting the indemnifying
Party, at the indemnifying Party’s reasonable expense, in the investigation of, preparation for and
defense of any such claim, demand, causes of action or suit; and (iv) not compromising or settling
such claim, demand, causes of action or suit without the indemnifying Party’s prior written
consent. Notwithstanding the foregoing, the indemnifying Party will not enter into any settlement
that would adversely affect the indemnified Party’s rights hereunder or impose any obligations on
the indemnified Party in addition to those set forth herein without the indemnified Party’s prior
written consent, which will not be unreasonably withheld or delayed. The indemnified Party will
have the right, but not the obligation, to be represented in such defense by counsel of its own
selection and at its own expense. The indemnifying Party will not be responsible for any
attorneys’ fees or other costs incurred other than as provided herein.

     9.4 Limitation of Liability. Neither Party shall be liable to the other Party for
incidental, consequential or punitive damages arising out of or relating to this Agreement, whether
those damages arise under contract, tort (including negligence) or another legal theory. If
applicable law prevents enforcement of this Section, then this Section will be deemed modified to
provide the maximum protection to each Party as is allowable under

Clovis MSA
3-17-10

 

 

applicable law. The foregoing exclusion of damages will not limit (i) either Party’s indemnity
obligations under this Agreement for third party claims, (ii) damages or liability arising out of
either party’s intentional or knowing breach of the provisions regarding Confidential Information,
or (iii) either party’s gross negligence or intentional misconduct (where “gross negligence” means
the failure to perform a manifest duty in reckless disregard of the consequences as affecting the
life or property of the other).

10. Representation and Warranties

     10.1 Each Party represents and warrants to the other that it is not bound by any other
agreement which could prevent, or be violated by, or under which there would be a default as a
result of, the execution and performance of this Agreement, and that the Parties or either of them
will not enter into any such agreements during the term of this Agreement.

     10.2 Each Party warrants and represents to the other that neither it nor any of its employees:
(i) are under investigation by any regulatory agency, medical ethics body or other agency or
authority that regulates the marketing of pharmaceuticals or the medical or healthcare profession
(“Regulatory Agency”) for debarment, discipline or disqualification nor are they presently
debarred, disciplined or disqualified by any Regulatory Agency; and (ii) have been debarred,
disciplined or disqualified by any Regulatory Agency and do not have a debarment, disciplinary or
disqualification hearing pending. If during the term of this Agreement, either Party or any of a
Party’s employees (A) comes under investigation by any Regulatory Agency for any debarment,
disciplinary or disqualification action; or (B) becomes debarred, disciplined or disqualified, such
Party will immediately notify the other Party and the Parties will discuss and agree upon a course
of action to address the issue.

     10.3 THE REPRESENTATIONS AND WARRANTIES SET FORTH ABOVE ARE IN LIEU OF ANY AND ALL OTHER
WARRANTIES AND REPRESENTATIONS, EXPRESS, IMPLIED, OR STATUTORY INCLUDING, WITHOUT LIMITATION, ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR FOR NON-INFRINGEMENT
OF A PATENT, TRADEMARK OR OTHER INTELLECTUAL PROPERTY RIGHT. EACH PARTY DISCLAIMS ANY AND ALL
OTHER WARRANTIES OR REPRESENTATIONS, EXPRESS, IMPLIED OR STATUTORY, INCLUDING, WITHOUT LIMITATION,
ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR FOR
NON-INFRINGEMENT OF A PATENT, TRADEMARK OR OTHER INTELLECTUAL PROPERTY RIGHTS.

11. Force Majeure

     Neither Party shall be liable for failure or delay in performance under this Agreement due to
causes such as an act of God, strike, lockout or other labor dispute, civil commotion, sabotage,
fire, flood, explosion, acts of any government, any other causes not within the reasonable control
of the Party affected (a “Force Majeure Event”). In the event either Party is unable to perform
any of its obligations hereunder due to a Force Majeure Event, such Party shall promptly notify the
other Party. Performance hereunder shall be promptly resumed after the applicable Force Majeure
Event has been remedied, otherwise this Agreement may be terminated as provided in Article 8.

12. Notice

     All notices under this Agreement shall be in writing and shall be sent by registered or
certified mail, postage prepaid, or by overnight courier service, to the following addresses of the
respective Parties:

If to Clovis:

Clovis MSA 3-17-10

 

 

Clovis Oncology, Inc.

2525 28th Street, Suite 180

Boulder. CO 80301

Attn: Chief Financial Officer

FAX: ***

If to Ventana:

Ventana Medical Systems, Inc.

1910 East Innovation Park Drive

Tucson, AZ 85755

Attn: Legal Department

Fax: ***

13. Governing Law

     The formation, existence, performance, validity and all aspects of this Agreement and of any
Contract shall be governed by and construed in all respects in accordance with the laws of the
state of Arizona.

14. Entire Agreement, Amendment or Variation

     This Agreement sets out the entire agreement and understanding between the Parties regarding
the subject matter of this Agreement and supersedes all prior discussions, arrangements and
agreements, whether oral or in writing or which may be inferred from the conduct of the Parties.

15. Validity/Severability

     The invalidity or unenforceability of any provision of this Agreement shall not affect the
validity or enforceability of any other provision which shall remain in full force and effect. The
Parties shall use their reasonable efforts to achieve the purpose of the invalid provision by a new
legally valid stipulation.

16. Assignment

     This Agreement may be assigned by either Party to any corporate affiliate of such party or to
any successor in interest by reason of any merger, acquisition, reorganization, or consolidation
without the other Party’s consent. Any attempt by either Party to effect any other assignment
without the consent of the other Party will be void and without effect.

17. Waiver; Modification of Agreement

     No waiver, amendment, or modification of any of the terms of this Agreement shall be valid
unless in writing and signed by authorized representatives of both Parties. Failure by either
Party to enforce any rights under this Agreement shall not be construed as a waiver of such rights
nor shall a waiver by either Party in one or more instances be construed as constituting a
continuing waiver or as a waiver in other instances.

18. Relationship of the Parties

     The relationship of the Parties is that of independent contractors.

Clovis MSA 3-17-10

 

 

19. Independent Development

     Except as provided in Section 7 (Intellectual Property) and subject to Section 5 (Material
Transfer) and Section 6 (Confidentiality), the business relationship contemplated by the Parties in
this Agreement will not be construed as restricting Ventana’s ability to independently acquire,
license, develop, manufacture or distribute for itself, or have others acquire, license, develop,
manufacture or distribute for Ventana, similar technology performing the same or similar functions
as the technology contemplated by this Agreement, or to market and distribute such similar
technology in addition to, or in lieu of, the technology contemplated by this Agreement.

20. Use of Parties Names

     Neither Party shall make (or have made on its behalf) any oral or written release of any
statement, information, advertisement or publicity in connection with this Agreement which uses the
other party’s name, symbols, or trademarks without the other Party’s prior written approval.

21. Records

     Ventana agrees to maintain for a period of two years after the termination or expiry of this
Agreement adequate records of, and copies of all receipts for expenses incurred in connection with,
the performance of the Services and allow access to Clovis and its authorized representatives to
inspect such records and receipts upon reasonable notice.

     IN WITNESS WHEREOF, this Agreement is executed, to be effective as of the Effective Date.

	 	 	 	 	 	 	 	 	 	 	 

	CLOVIS ONCOLOGY, INC.	 	 	 	VENTANA MEDICAL SYSTEMS, INC.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	/s/ Patrick J. Mahaffy
	 	 	 	 	 	/s/ Doug Ward	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	Patrick J. Mahaffy
 

	 	 	 	By:
	 	Doug Ward
 

	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date:

	 	March 23, 2010 

	 	 	 	Date:
	 	25-MAR-2010 
	 	 

EXHIBIT A

FORM OF SCHEDULE

Clovis MSA 3-17-10

 

 

Schedule 1

To Master Services Agreement

INDIVIDUAL PROJECT AGREEMENT:

This Individual Project Agreement (IPA), effective as of the date of the last authorized
signature below, includes the Scope of Work and Budget incorporated herein. By this IPA, Clovis
authorizes Ventana to undertake on a Project-by-Project basis, in accordance with the terms of the
Master Services Agreement between the parties dated 23 March, 2010 the laboratory services set
forth in the Scope of Work and accompanying Budget. Services or verbiage in this IPA may be
modified at any point with a mutually agreement upon signed addendum.

Roles and responsibilities:

Clovis
contacts for the Projects are: *** 

Ventana contacts for the Projects are: ***

	 	 	 	 	 	 	 	 	 
	Name	 	Title	 	Phone & Fax	 	Address	 	Email Address
	***

	 	Head of Molecular
Diagnostics
	 	***
	 	***
	 	***
	***

	 	Director Business Development
	 	***
	 	***
	 	***
	***

	 	Senior Scientist
	 	***
	 	***
	 	***
	***

	 	Project Manager
	 	***
	 	***
	 	***

Ventana
and Clovis will schedule a *** operations teleconference.

Clovis hENT1 BIOMARKER ASSAY PROJECT(S)

	 	1)	 	Project 1: Antibody Screening
	 
	 	2)	 	Project 2: Develop a PMA ready Class 1 Exempt IVD automated in-vitro Diagnostic IHC
assay for hENT1
	 
	 	3)	 	Project 3: Clinical utility testing of hENT1 in a phase II clinical trial
	 
	 	4)	 	Project 4: Preparation and submission of PMA Class 3 IVD application for hENT1 Companion Diagnostic

Commencement of each Project will only occur if Clovis finds results of previous Project
acceptable, and provides written confirmation to Ventana to commence the next Project.

Project 1: Antibody Screening

1.0 Project Summary

 

INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

	 	•	 	Companies: Clovis
	 
	 	•	 	Study Title: Screen hENT1 antibody for suitability on Ventana’s automated system.
	 
	 	•	 	Study Identification: Clovis hENT1 BIOMARKER PROJECT
	 
	 	•	 	Proposed Study Initiation Date: Feb 2010
	 
	 	•	 	Proposed Study End Date: March 2010
	 
	 	•	 	Primary Ventana Contacts:  ***
	 
	 	•	 	Primary Clovis Contacts:  ***

2.0 Experimental Plan

2.1 Screening

Ventana will perform the following activities for assays to be utilized in the Ventana
Pharma Services Laboratory. Ventana will not necessarily rely on tissues sourced from
Clovis. The expected performance criteria for the assay will be clearly expressed by the
scientific teams at Clovis and Ventana. It is expected that Clovis will share all
appropriate knowledge with the Ventana team to allow determination of which cell lines,
tissues etc. will be most suitable for the development and analytical validation of the
assay at each stage. These materials could be available from Ventana’s in house resources,
shared from Clovis or may need to be procured. Procurement of materials may change
timelines and will incur pass thru costs. In Ventana’s experience it is most efficient to
identify these needs prior to commencing the assay development. The protocols for detection
of hENT1 on Ventana’s automated staining platform which are developed under this contract
will be transferred to Clovis. Reagents and kits are not produced from the prototype assays
developed under this contract.

2.1.1 Screening

Ventana
will screen the monoclonal hENT1 antibody generated by *** for suitability
for immunohistochemistry and compatibility with Ventana’s automated immunohistochemistry
platforms. This screen will consist of staining appropriate tissue specimens with the
antibodies under experimental conditions which, in Clovis and Ventana’s experience, are
likely to yield a signal.

If the antibody screening is successful, this antibody will be selected and an automated
immunohistochemistry assay for use on Ventana’s platform will be developed and
analytically validated.

If screening is not satisfactory then this will be communicated to Clovis and either 1)
an additional antibody or antibodies will be screened upon mutual agreement of

2

 

INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

terms by Clovis and Ventana, 2) additional assay conditions will be tested upon mutual
agreement of terms by Clovis and Ventana, or 3) the attempt will be declared a failure,
and an Antibody Screening Failure worksheet will be completed.

Ventana will perform pre-analytical experiments to determine the optimal sample
processing procedures (eg type of buffer, fixatives). Ventana will cut additional
slides and look at the stability of the hENT1 epitope over time.

If Clavis is able to provide the blocking peptide or the sequence of the epitope, then
Ventana will use this in its specificity testing.

3.1 Project Management

***
will function as the Ventana project manager for the Clovis hENT1 BIOMARKER
PROJECT. Teleconferences will be scheduled at agreed upon intervals (eg weekly) to report
on progress and make mutual decisions.

3.1 Inventory and Maintenance of Records, Slides and Blocks

Upon receipt of cell pellets, xenografts or other specimens from Clovis, Ventana will
inspect the condition of the shipment and verify the identity of all specimens listed on the
package manifest.

The information provided with the shipped specimens is logged into Ventana’s proprietary
Oracle-based laboratory management system (LMS). All specimens will be appropriately
labeled, tracked and stored in a secure locked area under proper conditions until analysis.

Ventana will retain under secure conditions all specimen blocks, stained and unstained
slides, and documentation relevant to this project for a period of
*** years after
final payment in accordance with the provisions of the Master Service Agreement. This will
include, but not be limited to: all experimental and data handling processes (SOPS);
specific notations by which the Clovis data was generated and entered into a database; and
the record layout and file transfer format as separately determined by Clovis and Ventana
during the testing process. Additionally, notebooks with hard copy results, instrumentation
calibration maintenance records for the contract period, specific validation methods and
results, and any other records relevant to the project, will be maintained. At the end of
this period, Ventana will contact Clovis to determine their requirements for further
disposition of all records and specimen materials for the Clovis hENT1 BIOMARKER PROJECT.

4.0 SCHEDULE OF EVENTS

3

 

INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Schedule:
Antibody screening of hENT1 will be complete by *** The duration
of this project is assumed to be approximately ***.

Unanticipated Delays: The immunohistochemistry process and analyses developed by Ventana
involve the use of several instruments and many processing steps and reagents, any of which may
fail unexpectedly. The quality controls and assurances in place at Ventana have been designed to
identify discrepancies and problems soon after occurrence to allow for a quick response and
resolution without impeding productivity. However, there may be unanticipated delays to obtaining
high quality data and in delivering data reports because of some unusually difficult problems.
Possible scenarios that may cause a delay include, but are not limited to:

	 	•	 	Problems with quality, consistency, stability, or supply of antigen retrieval agents
from an outside vendor (i.e. ficin) or from Ventana (i.e. citrate, EDTA, proteinase K)
	 
	 	•	 	Problems with quality, consistency, stability, or supply of primary antibodies from
outside vendor or from Ventana
	 
	 	•	 	Problems with quality, consistency, stability of secondary and detection reagents from
outside vendors or Ventana
	 
	 	•	 	Instrument failure (autostainers, microtomes, automatic cover-slipper, imaging
microscope, etc.)
	 
	 	•	 	Loss of trained personnel due to attrition or illness

When Ventana experiences a problem that interferes with the generation of reproducible
immunostaining and high quality data within the agreed upon timeline, Clovis will receive written
notification detailing the issues, outlining the resolution steps, and updating the timeline. It
stands to reason that if there is a failure that necessitates a repeated experimental run,
additional sections will be needed from the affected specimens in order to complete the study. A
tabulation of the additional sections required to complete the study will be communicated to
Clovis.

Likewise, in the event that Clovis experiences delays in slide collection, or makes changes in that
protocol that impacts Ventana’s responsibilities and planning, Ventana expects notification in
order to update its resource commitments and timelines with possible re-negotiations if the
anticipated impact is considered significant.

4

 

INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

5.0 BUDGET

***

5

 

INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Project 2: Develop a PMA ready Class 1 Exempt IVD automated in-vitro Diagnostic IHC assay for hENT1

Specifications:

An automated in-vitro Diagnostic hENT1 IHC assay will be developed by Ventana for use in Clovis
therapeutic clinical trials. This will be accomplished according to quality systems regulation
(QSR) requirements under GMP conditions. The final deliverable will be an assay ready for use in a
pivotal trial. A full development contract will be developed according to Ventana’s product
development process. Key parameters to be defined in contract include, but are not limited to,
schedule milestones, product requirements, project cost targets, and operational targets.

The key tasks include Design Goal (Feasibility phase), Design Input (Development), and Design
Output (Implementation), the details of which are outlined in Appendix B.

Control cell lines will be acquired and grown for the development of this assay.

This process will not need to be repeated if additional tumor types are to be pursued.

Timelines:

Ventana will begin work on as much of the development steps as possible before receiving the
hybridoma.

This
development project will begin when the paperwork is signed and will
end on or before *** months
of the start date. A summary of the estimated time schedules once an agreement is signed is as
follows:

Appendix A is a gantt chart that represents the timeline should Ventana receive the hybridoma by
the data listed. Any delay in receiving the hybridoma will delay the timeline.

Appendix B includes additional details to the deliverables and milestones in the Design Goal,
Design Input and Design Output portions listed above.

Appendix C includes the overview of hybridoma maintenance/storage and testing.

6

 

INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Budget:

***

7

 

INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Project 3: Clinical utility testing of hENT1 in a retrospective patient observational study and a prospective
phase II clinical trial of patients with pancreatic cancer

1.0 Project Summary

	 	•	 	Company: Clovis
	 
	 	•	 	Study Title: TBD
	 
	 	•	 	Study Identification: Evaluation of hENT1 in a retrospective patient
observational study and a prospective phase II clinical trial
	 
	 	•	 	Purpose: Evaluation of Tissue biomarkers by INC assay in patient biopsies for hENT1
	 
	 	•	 	Assay(s) Requested: hENT1 IHC
	 
	 	•	 	Number of Specimens to be analyzed: ***
	 
	 	•	 	Maximum Number of Slides Needed for Analysis: TBD
	 
	 	•	 	Proposed Study Initiation Date: TBD
	 
	 	•	 	Proposed Study End Date: TBD

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

2.0 Study Plan

2.1 Description of Study

Evaluation of hENT1 by an IHC assay in retrospective patient biopsies and a prospective
phase II clinical trial of patients with pancreatic cancer

2.2 Sample Procurement

Clovis will procure baseline biopsies from patients for shipping to Ventana for use in this
study. Ventana will provide detailed instructions for sample collection, labeling, and
shipping will be provided with a supply of addressed shipping containers. A detailed
description of tumor collection and shipment kits is provided in Appendix D for inclusion in
study lab manual. Blocks and slides should be packed in ice or cold packs prior to shipping
priority overnight. If requested as a feature of this agreement, appropriate fixation
(formalin) and storage (70% ethanol) solutions will also be provided for specimens. If
available, a copy of the original pathology report containing the histopathological
diagnosis should accompany each specimen (this will aid Ventana’s scientific reviewers and
pathology consultants in their evaluation of the H&Es and in the association of specific
immunostaining with disease pathology). Ventana is available to respond to any questions
from the site regarding the administrative and technical issues pertaining to preparation of
blocks/slides. In the event that Clovis experiences delays in patient recruitment or in the
collection of appropriate specimens, Ventana expects notification in order to update its
resource commitments and timelines. The desired specimen characteristics are: 1) Tissues
fixed in neutral buffered formalin (NBF); 2) Blocks preferable to slides; 3) If slides are
supplied, sections must be a) mounted on positively charged slides of the correct type, b)
have been transferred to the slide in a water bath (not by tape), c) not have been
baked (the slide containing the mounted specimen should not have been dipped in paraffin),
and d) stored at 4 C in an airtight container prior to shipment.

A minimum of 2 slides would be required but 5 slides would be desired from each patient to
conduct the analysis.

2.3 Accessioning, Processing and Analysis

After receipt and accessioning, specimens will be processed, embedded and have an H&E
performed by a board-certified pathologist to ensure that the tissue is suitable for IHC.
This will be completed within *** of receipt of the specimen. Ventana will complete
testing on Saturday if necessary to achieve the ***  turnaround time. However, if the
specimen is received after ***  from collection, then Ventana cannot be held to ***
turnaround. The data report form will be sent to the site and to Clovis.

H&E stain and a positive control stain are used to evaluate the suitability of the tissue
for immunohistochemical analysis. The requested staining will be performed as specified by
Translational Diagnostics’ protocol #s listed below in Table, including a negative control.
An appropriate positive control tissue is included in each staining run, as is a system
control to verify system performance.

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	 	 	 	 	Assay Protocol
	Priority	 	Biomarker Target	 	Number
	1

	 	H & E	 	 	 	 
	2

	 	Vimentin
	 	 	940	 
	3.

	 	hENT 1
	 	TBD

	4.

	 	hENT 1 Negative
	 	TBD

Data are collected in a format agreed upon by Clovis and Ventana or based on Ventana’s
experience.

An appropriate scoring method will be developed based upon the literature and observational
studies.

Subcellular localization (nucleus, cytoplasm, and/or cell membrane) of antibody reactivity
will also be recorded.

Other methods may be used by Ventana’s pathologists to collect data if agreed upon by Clovis
and Ventana. Specimens which are deemed by the pathologist to be uninterpretable will be
recorded as such. Pathologists may also add comments for a more thorough interpretation of
the specimen and/or staining.

A digital image quantification system may be used. Typically, mean optical density of
staining in the expected subcellular compartment (of at least three fields per specimen, if
possible) will be measured. Samples may be excluded from image analysis at Ventana’s
discretion for the following reasons: staining pattern, specimen size, or condition of
specimen. All excluded samples will be recorded as such.

A training set of specimens collected under conditions identical to those of the study may
be necessary for algorithm refinement.

Manual pathology reads of staining of positive and negative controls are also recorded. A
positive control antibody may be used to measure the following: tissue integrity,
consistency of fixation, and/or staining capacity of the sample. A negative control, which
may consist of either species matched immunoglobulin or antibody diluent, is used to measure
background staining on a given specimen. The negative control may also be used to set the
baseline OD for an imaging system.

There are multiple reviews throughout the immunostaining process carried out by Ph.D. or
M.D. level staff, with a final analysis by a board certified pathologist.

Image analysis data from the microscope-based image analyzer are entered into the
Translational Diagnostics proprietary LMS database. The images of the stained tissue
sections that are captured by the analyzer during processing are downloaded to tapes on an
as needed basis and stored in a secure location.

The interpretation of biomarker staining by the certified pathologist (percent positive
cells and intensity determinations) is hand written on designated data collection sheets.
All

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

reports (written or electronic) and other experimental information or data are collected,
verified, signed if appropriate, and stored in a designated project notebook in a fireproof
locked cabinet at Ventana.

Ventana will transfer data to Clovis electronically in a format supported by Ventana or data
will be burned onto a CD and sent by courier overnight. Ventana will export data from the
LMS into an Excel spreadsheet. The Excel spreadsheet will be designed to satisfy Clovis
regulatory needs and export will be validated to ensure data export accuracy. Project
updates along with any new data will be transferred once a month. Clovis will also receive
hard copies of all reports via express mail.

At any time during the study, if data corrections are required because of a Ventana error
that is identified either at Ventana or at Clovis, an agreement between the parties will be
drafted outlining the protocol and time line for making the necessary corrections. Upon
completion of the corrected study or analysis, all data and a regenerated final report will
be forwarded to Clovis in the agreed format at no additional charge. All corrected reports
will be designated by a version number and date with clear explanation of the circumstances
that led to an updated corrected data set being generated.

If Clovis requests a reassessment of a slide analysis that deviates from the standard
procedures at Ventana, then upon agreement on the protocol, time line and additional
charges, Ventana will make the requested revisions, regenerate the records, and forward the
corrected files to Clovis in the agreed upon format. All revised reports will be designated
with a version number, date of revisions, and a clear explanation of the circumstances that
lead to an updated data set being generated.

2.4 Data Analysis and Report

At the completion of the project, data will be communicated to Clovis in Translational
Diagnostics’ standard Study Report Package. A Study Report template is available on
request.

2.5 Post-Study Analysis

After Ventana has reported the pathology scores and/or imaging data from the blinded read, a
second nonblinded session can be arranged to examine the slides for any quantitative or
qualitative information that may pertain to patient response (correlation with other (non
IHC) biomarkers, DFS, PFS, tumor regression). A re-inspection of the slides (or subset of
the slides) may reveal subtle differences in subcellular localization, morphology, or cell
type specific staining which was not apparent in the initial read. Work performed is
subject to per diem charges as in Section 5.0.

3.0 Logistics

3.1 Project Management

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

***  will function as the Ventana project manager for the Clovis Biomarker project.
Teleconferences will be scheduled at agreed upon intervals to report on progress.

3.2 Inventory and Maintenance of Records, Slides and Blocks

Upon receipt of specimens from clinical sites, Ventana will inspect the condition of the
shipment and verify the identity of all specimens listed on the package manifest.

The information provided with the shipped specimens is logged into Ventana’s proprietary
Oracle-based laboratory management system (LMS). All specimens will be appropriately
labeled, tracked and stored in a secure locked area under proper conditions until analysis.

Ventana will retain under secure conditions all specimen blocks, stained and unstained
slides, and documentation relevant to this project for a period of *** after
final payment in accordance with the provisions of the Master Service Agreement. This will
include, but not be limited to: all experimental and data handling processes (SOPS);
specific notations by which the Clovis data was generated and entered into a database; and
the record layout and file transfer format as separately determined by Clovis and Ventana
during the testing process. Additionally, notebooks with hard copy results, instrumentation
calibration maintenance records for the contract period, specific validation methods and
results, and any other records relevant to the project, will be maintained. At the end of
this period, Ventana will contact Clovis to determine their requirements for further
disposition of all records and specimen materials for the Clovis Biomarker study.

4.0 SCHEDULE OF EVENTS

Schedule:
CLINICAL TRIAL will begin Q2 2010 and is expected to enrolled the last
randomized patient in ***.

Study Protocol: Upon acceptance of this individual project agreement, a study protocol
will be developed to specify the methods to be used, batching of samples, pathology scoring,
reporting of results and other relevant study details. This study protocol shall be submitted to
Clovis for acceptance prior to receipt and analysis of any specimens.

Lab Manual: A laboratory manual will be developed with input from both Ventana’s project
management team and Clovis. An example laboratory manual has been provided.

StudyTraining: Ventana will have personnel available investigator meetings and site
training (Webex preferred when available).

Unanticipated Delays: The immunohistochemistry process and analyses developed by Ventana
involve the use of several instruments and many processing steps and reagents, any of which may
fail unexpectedly. The quality controls and assurances in place at Ventana have been designed to
identify discrepancies and problems soon after occurrence to allow for a quick response and
resolution without impeding productivity. However, there may be unanticipated

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

delays to obtaining high quality data and in delivering data reports because of some unusually
difficult problems. Possible scenarios that may cause a delay include, but are not limited to:

	 	•	 	Problems with quality, consistency, stability, or supply of antigen retrieval agents
from an outside vendor (i.e. ficin) or from Ventana (i.e. citrate, EDTA, proteinase K)
	 
	 	•	 	Problems with quality, consistency, stability, or supply of primary antibodies from
outside vendor or from Ventana
	 
	 	•	 	Problems with quality, consistency, stability of secondary and detection reagents from
outside vendors or Ventana
	 
	 	•	 	Instrument failure (autostainers, microtomes, automatic cover-slipper, imaging
microscope, etc.)
	 
	 	•	 	Loss of trained personnel due to attrition or illness

When Ventana experiences a problem that interferes with the generation of reproducible
immunostaining and high quality data within the agreed upon timeline, Clovis will receive written
notification detailing the issues, outlining the resolution steps, and updating the timeline. It
stands to reason that if there is a failure that necessitates a repeated experimental run,
additional sections will be needed from the affected specimens in order to complete the study. A
tabulation of the additional sections required to complete the study will be quickly communicated
to Clovis.

Likewise, in the event that Clovis experiences delays in slide collection, or makes changes in that
protocol that impacts Ventana’s responsibilities and planning, Ventana expects notification in
order to update its resource commitments and timelines with possible re-negotiations if the
anticipated impact is considered significant.

5.0 BUDGET

***

Translational Diagnostic Retrospective Clinical Sample Analysis - Itemized Laboratory Services & Fees

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Preparation, Staining, and Pathology

Scoring Description	 	 	ESTIMATED # OF

SPECIMENS	 	 	 	COST PER

TEST ($)	 	 	 	TOTAL $	 

* * *

 

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	Preparation, Staining, and Pathology

Scoring Description

	 	ESTIMATED # OF

SPECIMENS

	 	 	 	COST PER

TEST ($)

	 	 	TOTAL $

	 
	 

 

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

	 		
	•	 	Translational Diagnostic Retrospective Clinical Sample Analysis - Itemized  Fixed Costs

	 	 	 	 	 	 	 	 	 	 	 	 
	Itemized Laboratory

Services	 	 	Description of Services	 	 	Cost	 	 	Multiplier	 	 	Total

Cost

 

***

Translational Diagnostic Prospective Phase II Clinical Sample Analysis - Itemized Laboratory Services & Fees

	 	 	 	 	 	 	 	 	 
	Preparation, Staining, and Pathology

Scoring Description	 	 	ESTIMATED # OF

SPECIMENS	 	 	COST PER

TEST ($)	 	 	TOTAL $

 

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Translational Diagnostic Prospective Phase II Clinical Sample Analysis - Itemized Fixed Costs

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Itemized Laboratory

Services	 	 	Description of Services	 	 	 	Cost	 	 	 	Multiplier	 	 	 	Total

Cost	 

 

***

Expansion Phase Specifications:

If required either for the inclusion in the NDA and/or the Pre-Market Approved (PMA) for a Class 3
IVD, Ventana will support the diagnostic testing of hENT1 in a Clovis-conducted clinical trial
expansion of their prospective Phase II study. The costs to Clovis for analysis of such tissue
samples by Ventana are in list below. Preparation and submission of PMA Class 3 IVD application to
FDA will follow, in accordance with FDA regulations and guidelines.

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Translational Diagnostic Clinical Sample Analysis - Itemized Floating Costs

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Itemized Laboratory

Services	 	 	Description of Services	 	 	 	Cost	 	 	 	Multiplier	 	 	 	Total

Cost	 

 

***

Translational Diagnostic Clinical Sample Analysis - Cancellation or Rush Order Fees

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

***

Project 4: Preparation and submission of PMA Class 3 IVD application for hENT1 Companion
Diagnostic

Project Plan Purpose:

To prepare, submit, and support PMA regulatory filing for the hENT1 IHC IVD.

Specifications:

Upon completion of the pivotal trial, Ventana will prepare and submit a PMA Class 3 IVD application
with the FDA. Meetings with Regulatory agencies will have representation from Ventana, Clovis
and/or Clovis-designated consultants.

Ventana will also perform the required tasks for a PMA Class 3 IVD product such as the development
of control slides, packaging changes or package inserts.

Ventana will co-ordinate and resource an Inter-laboratory Reproducibility Study. This includes
inter-pathologist variability analysis as per FDA guidelines.

Timelines and Fees:

Milestones and Cost Associated with a PMA FDA and CE Mark Submission for Pancreatic Cancer

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

	 	 	 	 	 	 	 
	 	 	 	 	Estimated Time to	 	 
	Milestones	 	Details	 	Complete	 	Cost
	1. Preparation and
Submission of
courtesy submission
to FDA for
Companion
Diagnostic hENT1
Assay (pre-IDE)

	 	This includes FTE
time from
individuals on
*Ventana’s Core
Team. They will
develop, submit and
discuss a pre-IDE
with the FDA for a
future PMA
submission
	 	***
	 	***
	2. Perform
statistical
analysis of
Companion
Diagnostic hENT1
trial data

	 	This includes FTE
time from
individuals on
Ventana’s Core
Team. Statistical
analysis will be
performed on all
the data generated
to ensure that the
most robust data
set can be
achieved.
	 	***
	 	***
	3. Databasing

	 	Maintenance of data
in a quality system
that can be audited
by the FDA for up
to 10 years
	 	***
	 	***
	4. Write Study
Report for
Companion
Diagnostic hENT1
clinical trial

	 	Ventana Core Team
will be utilized to
write a
comprehensive study
report from the
data generated at
all the sites and
on all the samples
	 	***
	 	***
	5. Preparation of
PMA FDA application
for Companion
Diagnostic hENT1

	 	Ventana’s Core Team
will perform a full
review of PMA
ensuring that all
the modules** have
been completed.
	 	***
	 	***
	6. Submission and
support of FDA of
PMA application to
the FDA for
Companion
Diagnostic hENT1

	 	Ventana’s
regulatory group
will submit the PMA
application
	 	***
	 	***
	7. Preparation of
Technical File for
CE Mark

	 	Ventana’s Core Team
will prepare the
technical file
ensuring module
conformity
	 	***
	 	***
	8. Preparation of
Declaration of
Conformity

	 	Ventana’s Core Team
will prepare and a
Declaration of
conformity for the
product
	 	***
	 	***
	9. Register Product
Through Ventana’s
Regulatory Group in
Europe

	 	Ventana will have
its’ European
regulatory group
submit the
declaration of
conformity for CE
mark
	 	***
	 	***

 

			
	*	 	Ventana Core Team includes individuals from the following Ventana groups: regulatory,
development, scientific affairs, statistics, clinical affair, medical affairs, quality, project
management, marketing, manufacturing and members of the executive management team.

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

	 	 	 
	**	 	There are multiple modules and the modules need to be consistent from module-to-module.

Subject to successful completion of all Projects contemplated by this IPA, the parties anticipate
cooperating to commercialize the diagnostic assay.

A
detailed version of the commercialization term sheet will be put in place prior to the end of Project 2.

PAYMENT TOTAL FOR IPA AND PAYMENT SCHEDULE

***

Invoicing and Payments:

Ventana will invoice Clovis monthly for all fees earned based on Services provided in the preceding
thirty (30) day period, plus any authorized pass-through expenses incurred during that time period.

All payments are due net thirty (30) days upon receipt by Clovis

Invoices can be sent via e-mail, courier or U. S. Post (e-mail preferred with any backup
documentation such as copies of receipts, etc. being scanned):

Clovis Clovis Oncology, Inc.

2525 28th Street, Suite 180

Boulder, CO 80301

Attn: Accounts Payable

Email:

All invoices must contain the following information:

	 	•	 	Invoice Number
	 
	 	•	 	Invoice Date
	 
	 	•	 	Clovis Protocol Number
	 
	 	•	 	Clovis Contract Number
	 
	 	•	 	Department Name
	 
	 	•	 	Account Code
	 
	 	•	 	Project Code (if applicable)

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

	 	•	 	Description of Service with itemization
	 
	 	•	 	Total Amount Due
	 
	 	•	 	Payee Name and Tax ID Number
	 
	 	•	 	Payment Address
	 
	 	•	 	Contact Person for any Invoice Questions

All invoices will be paid by Clovis as follows:

	 	 	 	 	 	 	 

	 

	 	•	 	Payee:	 	Ventana Medical Systems, Inc
	 

	 	•	 	Tax Payer ID#:	 	94-2976937
	 

	 	•	 	Address:	 	P.O. Box 3232
	 

	 	 	 	 	 	Carol Stream, IL 60132-3232

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

	 	 	 	 	 	 	 

	AGREED AND ACCEPTED

	 	 	 	AGREED AND ACCEPTED	 	 
	Clovis Oncology, Inc.

	 	 	 	Ventana Medical Systems, INC.	 	 
	 
	 	 	 	 	 	 
	/s/ Patrick J. Mahaffy
 

(Signature of Authorized Official)

	 	 
	 	/s/ Doug Ward
 

(Signature of Authorized Official)
	 	 
	 
	 	 	 	 	 	 
	Patrick J. Mahaffy
 

(Typed or Printed Name and Title)

	 	 
	 	Doug Ward, GMTD
 

(Typed or Printed Name and Title)
	 	 
	 
	 	 	 	 	 	 
	March 23, 2010
 

(Date)

	 	 
	 	25-MAR-2010
 

(Date)
	 	 
	 
	 
	 	 	 	 	 	 
	 

(Signature of Authorized Official — Procurement)

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

(Typed or Printed Name and Title)

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

(Date)

	 	 	 	 	 	 

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Appendix A

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

Appendix B

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

***

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***

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***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

***

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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL

***

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***

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***

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Appendix C

***

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***

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Appendix D: Clinical Sample Procurement & Collection Reagents/Kits

Archival Kit:

     Provided to the Institution

	 	o	 	Ventana requisition form
	 
	 	o	 	Specimen labels
	 
	 	o	 	Bio-Hazard bag for shipping Paraffin Block
	 
	 	o	 	20 SuperFrost Plus Positively Charged microscope slides (depends on # of slides
needed per study)
	 
	 	o	 	4 slide containers (depends on # of slides needed per study)
	 
	 	o	 	1 specimen kit foam padded boxes
	 
	 	o	 	FedEx air bill
	 
	 	o	 	Return shipping box

     Provided by the Institution

	 	o	 	Fine point permanent marking pen for labels
	 
	 	o	 	Packing tape

Fresh Tumor Biopsy Kit:

     Provided to the Institution

	 	o	 	Ventana requisition form
	 
	 	o	 	Specimen labels
	 
	 	o	 	One 60 ml pre-filled polypropylene container that contains 30 ml of 10%
neutral-buffered formalin
	 
	 	o	 	One tissue cassette
	 
	 	o	 	One 60 ml polypropylene container 95kPa approved
	 
	 	o	 	Parafilm
	 
	 	o	 	Specimen kit box (Foam Padded)
	 
	 	o	 	Plastic document bag for the completed study requisition form
	 
	 	o	 	Plastic bio-hazard bag for the polypropylene container and tissue cassette
	 
	 	o	 	FedEx air bill
	 
	 	o	 	Return shipping box
	 
	 	o	 	Vermiculite — packaging
	 
	 	o	 	Return package label to be place on outside of shipping box — “Package
Conforms to 49 CFR 173.4”

     Provided by the Institution

	 	o	 	Biopsy surgical tools (per institutional and protocol procedures)

	o	 	Ethanol — V W R — EM-EX0281-1 (product number) — This is 70% Ethanol

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