exv10w28






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.







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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.







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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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INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL




	 	 	 	 	 	 	 
	 	 	 	 	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






12









 








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 $	 





* * *





 





13









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL










	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	Preparation, Staining, and Pathology

Scoring Description



	 	ESTIMATED # OF

SPECIMENS

	 	 	 	COST PER

TEST ($)

	 	 	TOTAL $

	 
	 





 





***







14









 








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 $





 




***









15









 








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.



***







16









 








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








***



17









 








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








18









 








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



***






23









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL




Appendix B



***






24









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






25









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






26









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






27









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






28









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






29









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






30









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






31









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






32









 








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***






33









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL




Appendix C



***






34









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL



***






35









 








INDIVIDUAL PROJECT AGREEMENT — CONFIDENTIAL




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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