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COLLABORATIVE RESEARCH AGREEMENT
BETWEEN
PFIZER INC. AND [ACADEMIC MEDICAL CENTER]
THIS COLLABORATIVE RESEARCH AGREEMENT (hereinafter ��Agreement��) is
entered into by and between
Pfizer Inc., a Delaware corporation having an office at 235
East 42nd Street, New York, New York 10017 (��Pfizer��); and
Academic Medical
Center, a [TYPE OF INSTITUTION] having an office at [INSERT ADDRESS]
(hereinafter ��AMC��) for the conduct of collaborative preclinical and clinical research
studies in the area of identification and testing of new disease indications for existing
Pfizer drug candidates.
WHEREAS, Pfizer is a party to a Memorandum of Understanding (the ��MOU��) with the
National Institutes of Health��s National Center for Advancing Translational Sciences
(��NCATS��) dated [insert date], the goal of which MOU is to encourage the discovery of
new therapeutic indications and/or diagnostics for existing drug candidates, and Pfizer is
in possession of certain such drug candidates (e.g., the Pfizer Compound, as defined
below) and data related thereto; and
WHEREAS, AMC desires to expand its capabilities and leading expertise in education,
research and/or clinical care, and AMC desires to apply for a NIH Grant (as defined
below) to perform studies related to the Pfizer Compound; and
WHEREAS, the studies contemplated by this Agreement will be of mutual interest and
benefit to Pfizer and AMC and the general public, and shall further the instructional and
research objectives of AMC in a manner consistent with its status as a nonprofit research,
education and healthcare institution; and
WHEREAS, the Parties desire to engage in a collaborative research program that will
advance scientific knowledge and patient care with the objective of validating, in human
clinical studies, a new disease indication for the Pfizer Compound.
NOW THEREFORE, in consideration of the mutual premises and covenants set forth
herein and intending to be legally bound the Parties hereby agree as follows:
1. Scope and Aims
1.1 This Agreement governs work performed in a collaborative research project in the
form of a Project Plan (as defined below) which may include preclinical work or
non-interventional clinical work or a Clinical Trial (as defined below) governed by
an IIR Agreement (as defined below). Each Party will perform the work that is
assigned to it in this Agreement, the Project Plan, and the IIR Agreement (if any).
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1.2 This Agreement and the IIR Agreement (if any) shall be consistent with the terms
and conditions of the NIH Grant.
2. Definitions
Unless the context otherwise requires, the following definitions shall have the following
meanings:
2.1 ��Affiliate�� means any company, body or other organization directly or indirectly
controlling, controlled by, or under common control with a Party to this
Agreement where ��control�� is defined as the direct or indirect holding of a
majority of the stock entitled to vote (or other voting interest) or to otherwise
appoint and remove the management of the company, body or organization.
2.2 ��AMC Invention�� has the meaning provided in
Section 8.2.1.
2.3 ��CDA�� means the Confidential Disclosure Agreement between Pfizer and AMC
dated [insert date] and incorporated herein by reference.
2.4 ��Clinical Trial�� means any study performed under this Agreement which includes
human subjects and the use of the Pfizer Compound.
2.5 ��Commercially Reasonable Efforts��means, with respect to the efforts to be
expended by a Party with respect to any objective, those reasonable, good faith
efforts to accomplish such objective as such Party would normally use to
accomplish a similar objective under similar circumstances. With respect to any
efforts relating to the development, Regulatory Approval, manufacture or
commercialization of a Product by Pfizer, generally or with respect to any
particular country, Pfizer will be deemed to have exercised Commercially
Reasonable Efforts if Pfizer has exercised those efforts normally used by Pfizer,
in the relevant country, with respect to a product or product candidate of similar
modality owned or Controlled by Pfizer, or to which Pfizer has similar rights,
which product or product candidate is of similar market potential in such country,
and is at a similar stage in its development or product life cycle as the Product,
taking into account all factors in effect at the time such efforts are to be expended.
It is expressly understood that the use of Commercially Reasonable Efforts may
result in ceasing the development, regulatory approval, manufacture or
commercialization of a Product. Further, to the extent that the performance of a
Party��s obligations hereunder is adversely affected by the other Party��s failure to
perform its obligations hereunder, the impact of such performance failure will be
taken into account in determining whether such Party has used its Commercially
Reasonable Efforts to perform any such affected obligations.
2.6 ��Confidential Information�� means, with respect to each Party, all Know-How or
other information, including proprietary information and materials (whether or not
patentable) regarding or embodying such Party��s technology, products, business
information or objectives, that is communicated by or on behalf of the Disclosing
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Party to the Receiving Party or its permitted recipients, on or after the date of the
existing Confidential Disclosure Agreement between the Parties regarding the
disclosure of information as contemplated by the MOU but only to the extent that
such Know-How or other information in written form is marked in writing as
��confidential�� at the time of disclosure, and such Know-How or other information
disclosed orally or in non-tangible form is (a) identified by the Disclosing Party as
��confidential�� at the time of disclosure and (b) within 30 days thereafter, the
Disclosing Party provides a written summary of such Know-How or other
information marked as ��confidential��. Confidential Information does not include
any Know-How or other information that (a) was already known by the Receiving
Party (other than under an obligation of confidentiality to the Disclosing Party) at
the time of disclosure by or on behalf of the Disclosing Party, (b) was generally
available to the public or otherwise part of the public domain at the time of its
disclosure to the Receiving Party, (c) became generally available to the public or
otherwise part of the public domain after its disclosure to the Receiving Party,
other than through any act or omission of the Receiving Party in breach of its
obligations under this Agreement, (d) was disclosed to the Receiving Party, other
than under an obligation of confidentiality, by a Third Party who had no
obligation to the Disclosing Party not to disclose such information to the
Receiving Party or (e) was independently discovered or developed by or on behalf
of the Receiving Party without the use of any Confidential Information belonging
to the Disclosing Party. The terms and conditions of this Agreement shall be
considered Confidential Information of both Parties.
2.7 ��Disclosing Party�� has the meaning provided in
Section 7.1.
2.8 ��Effective Date�� means [insert date], subject to the contingency of
Section 15.2.
2.9 ��Existing Technologies�� has the meaning provided in
Section 8.1.
2.10 ��HIPAA�� has the meaning provided in
Section 7.6.
2.11 ��IIR Agreement�� means the Investigator Initiated Research Agreement between
Pfizer and AMC for the conduct of any clinical trials which is attached to this
Agreement in
Exhibit B.
2.12 ��IND Application�� has the meaning provided in
Section 9.2.1.
2.13 ��Indication�� means [insert definition]
2.14 ��IRB�� means Institutional Review Board.
2.15 ��Joint Invention�� has the meaning provided in
Section 8.2.2.
2.16 ��Program Advisory Committee�� or ��PAC�� has the meaning provided in
Section
4.1.
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2.17 ��Material�� has the definition provided in
Section 5.3.
2.18 ��MOU�� has the meaning provided in the Recitals.
2.19 ��NIH Grant�� means any award made under the NIH-Industry Program:
Discovering New Therapeutics Uses for Existing Molecules.
2.20 ��NIH�� means the U.S. National Institutes of Health.
2.21 ��Option�� has the meaning provided in
Section 9.2.1.
2.22 ��Party�� means AMC or Pfizer. ��Parties�� means AMC and Pfizer.
2.23 ��Patent�� means any patent, certificate of invention, inventors certificate, utility
model or similar forms of protection, or other form of protection (including
applications, divisionals, continuations, continuations-in-part, and substitutions
thereof; all foreign patent applications corresponding to the preceding
applications or directly or indirectly claiming priority to or from any of the
foregoing; and all U.S. and foreign patents granted on any of the preceding
applications, including extensions, reissues, and reexaminations), granted
anywhere in the world covering an invention which is a Technical Development.
2.24 ��Pfizer Compound�� means [insert name of compound].
2.25 ��Pfizer Invention�� has the meaning provided in
Section 8.2.3.
2.26 ��PHI�� or ��Protected Health Information�� has the meaning provided in
Section
7.6.
2.27 ��Principal Investigator�� or ��PI�� means [insert name of AMC scientist]. The
Principal Investigator will be responsible for the conduct of the Program in
accordance with this Agreement.
2.28 ��Product�� means a pharmaceutical product in any jurisdiction in the world,
containing the Pfizer Compound, as approved by the appropriate regulatory
authority of that jurisdiction for the diagnosis, treatment or prevention of human
or animal diseases.
2.29 ��Program�� means all activities performed by or on behalf of AMC under the
scope of an NIH Grant or by or on behalf of Pfizer or their respective Affiliates
under this Agreement and which are authorized by this Agreement.
2.30 ��Program Contact�� means the person nominated by each of Pfizer and AMC to
serve as that Party��s contact for the Program as set forth in
Exhibit A.
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2.31 ��Project Plan�� means the project plan appended to this Agreement in
Exhibit A
and incorporated herein by reference.
2.32 ��Receiving Party�� has the meaning provided in
Section 7.1.
2.33 ��Results�� means the data and results arising from the Project Plan during the
Term.
2.34 ��Specific Success Criteria�� are the specific success criteria listed in the Project
Plan.
2.35 ��Technical Development�� means any invention, discovery, composition,
enhancement, technology, advancement, know-how, process, data, device,
machine, material, software or any other information arising from the Program,
including any such development protectable by patent, copyright, or other
protection under the law and in which a Party has an ownership interest.
2.36 ��Term�� has the meaning provided in
Section 3.1.
3. Term
3.1 Term. This Agreement is effective [insert date] and unless terminated in
accordance with the provisions of
Section 12 herein shall remain in full force and
effect for a period of [insert duration] years (the ��Term��) or until the completion
of the work under the Project Plan, whichever occurs first. The Agreement may
be extended by a period of time as the Parties may agree, by a written amendment
to this Agreement signed by both Parties.
4. Program Advisory Committee
4.1 Program Advisory Committee. The Parties recognize, because of the contributions
made to the Program by NCATS as a result of the NIH Grant, that NCATS has an
interest in the activities of the work under this Agreement. Accordingly, as
provided in
Section 1.2, nothing in this Agreement may be construed to conflict
with or supersede the rights and requirements of the NIH under the terms and
conditions of the NIH Grant or by operation of law or regulation. The Parties will
establish a program advisory committee (the ��Program Advisory Committee�� or
��PAC��) comprised of two (2) representatives, one from each of AMC and Pfizer
(the ��Contacts��), and up to four (4) additional members from each of AMC and
Pfizer. The names of the initial Contacts for each of Pfizer and AMC are set out in
Exhibit A. The PAC will:
4.1.1 review and make recommendations regarding changes to the Project Plan
based on emerging data as requested by the NIH Grantee;
4.1.2 monitor and facilitate the timely progress of the Project Plan;
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4.1.3 monitor and consider the protection of intellectual property arising from
results of the Project Plan, as necessary, and specifically prior to public
disclosures;
4.1.4 address such other matters relating to the activities of the Parties under this
Agreement as either Party may bring before the PAC, including any matters
that are expressly for the PAC to decide as provided in this Agreement; and
4.1.5 attempt to resolve any disputes on an informal basis.
4.1.6 align with and communicate with the steering committee of the NIH Grant.
4.2 Responsibilities of each Contact. Each Contact will:
4.2.1 alternate chairing of PAC meetings.
4.2.2 ensure alignment of their respective organizations on the objectives; the
AMC Contact will work with the PI and the AMC to ensure alignment on
the objectives, including any proposed changes to the Project Plan or
objectives, with NIH.
4.2.3 organize and circulate a written agenda in advance of PAC meetings;
4.2.4 prepare and promptly circulate minutes of the PAC meetings, clearly setting
out the decisions of the PAC and the follow-up actions of each Party
resulting from the meeting.
Furthermore, the Contacts from Pfizer and AMC will make decisions on those day
to day aspects of the Program which are not otherwise within the remit of the PAC.
The Contacts will bear overall accountability to their respective organizations for
the conduct of the Program.
4.3 Replacement of Contacts. Each Party��s Contact may only be replaced by the
written agreement of the other Party, such agreement not to be unreasonably
withheld or delayed.
4.4 Meetings. The Contacts will convene meetings of the PAC at least every three (3)
months at such times and places as agreed by the Parties. The Contacts may attend
the meetings in person or by audio teleconference or by video teleconference. Each
Party may invite additional employees who are not PAC Members to PAC meetings
at such Party��s discretion. Each Party shall be responsible for all of its own
expenses in participating in the PAC meetings. The Parties shall endeavor to
schedule meetings of the PAC at least three (3) months in advance.
4.5 Decision-Making. Decisions of the PAC must be unanimous; each Party has one
vote to be given by its Contact. If agreement cannot be reached and the PAC must
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have a decision to avoid any delay or prioritization of work, the Co-Chairs may
refer the matter to their respective senior management: [Insert Position] of AMC
and a Sr. Vice President of Pfizer Research and Development.
4.6 Limits on PAC Authority. Each Party shall retain the rights, powers and discretion
granted to it under this Agreement and no such rights, powers or discretion shall be
delegated to or vested in the PAC unless such delegation or vesting of rights is
expressly provided for in this Agreement or the Parties expressly so agree in
writing. The PAC shall not have the power to amend, modify or waive compliance
with this Agreement (other than as expressly permitted hereunder).
Notwithstanding anything herein to the contrary, neither Party shall require the
other Party to (i) breach any obligation or agreement that such Party may have with
or to a Third Party or (ii) perform any activities that are materially different or
greater in scope or more costly than those provided for in the Approved Project
Plans then in effect. It is outside the scope of the PAC��s authority to negotiate
license agreements under
Section 9.2.
5. Governance and Management
5.1 Progress Reports. The Principal Investigator is responsible for submission of
required NIH reports, including the annual progress report, invention statement,
and interim progress report upon completion of the first stage of the NIH grant.
The Principal Investigator will provide periodic progress reports of research
accomplishments, roadblocks, and milestones, monthly recruitment updates, and
other standard reports requested by the Program Advisory Committee.
5.2 Final Report. AMC shall cause the Principal Investigator to furnish to Pfizer a
comprehensive report within thirty (30) days after the completion of the Term,
describing in detail the work and Technical Developments accomplished on the
studies described in the Project Plan.
5.3 Transfer of Material. The transfer of Material from one Party to the other Party will
be governed by the terms and conditions of this
Section 5.3, unless the Parties
mutually agree otherwise. The Parties agree that the Pfizer Compound, and other
compounds, materials, biological samples, and other physical property (altogether,
the ��Material��) of each Party may be provided to the other Party and used by the
other Party solely for the purpose of the Project Plan and solely in the laboratories
or clinics of that Party by personnel described in the Project Plan. Accordingly, any
and all Material of a Party will be treated as Confidential Information of that Party
in accordance with
Article 7. Any transfer of Material or other physical property
by one Party to the other Party��s site shall require the prior written consent of both
Parties in the form of
Exhibit C1 (for the transfer of Material not derived from
human tissue) or
Exhibit C2 (for the transfer of Material derived from human
tissue). Detailed records of all such transferred items will be kept by AMC and
Pfizer. All such Material shall be transferred to the other Party by secure means.
All such Material shall remain the property of the transferring Party and will be
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surrendered to the transferring Party promptly or destroyed after the transferring
Party provides to the other Party a written request for such return or destruction. No
license, express or implied, is granted to the other Party in respect of such supplied
Material other than as expressly stated in this Agreement.
5.4 Project Clinical Trials. For any Clinical Trial or non-interventional clinical study
included in the Project Plan, the terms and conditions governing that component of
the Project Plan shall be governed to the maximum extent possible under this
Agreement, and the specifics of such work shall be as set forth in the Project Plan,
and in any applicable protocol, IND, and IRB approval. The Parties agree that such
Clinical Trial will be performed in compliance with all applicable laws and
regulations. AMC will sponsor any such Clinical Trials and any non-interventional
clinical studies, meaning the AMC will be responsible for filing the IND and
obtaining appropriate IRB approvals. For each such AMC-sponsored Clinical Trial,
the terms of this Agreement will be supplemented by an IIR Agreement in the form
set out in
Exhibit B and such other special and supplemental terms as the Parties
determine are necessary and appropriate at that time.
6. Funding and Resources
6.1 Pfizer will provide to AMC the Materials and information described in
Exhibit A.
6.2 Each Party will each bear any costs, expenses, or other charges of whatever nature
incurred by such Party and which are not expressly detailed in the Project Plan.
Pfizer will provide no funding to AMC for the work under this Agreement and the
Parties anticipate that AMC will obtain funding for AMC��s work under the Project
Plan solely from the NIH Grant.
7. Confidentiality
7.1 The Party receiving the Confidential Information (the ��Receiving Party��) of the
other Party (the ��Disclosing Party��) agrees to maintain the Disclosing Party��s
Confidential Information with at least the same degree of care it holds its own
information and in any case not less than a reasonable degree of care. The
Receiving Party will not use the Disclosing Party��s Confidential Information except
in connection with the Program, or as necessary to practice its rights under
Article
9. AMC will be permitted to disclose Pfizer Confidential Information to NIH to the
extent necessary to comply with the terms of the Program. The Receiving Party
will disclose the Disclosing Party��s Confidential Information only to its officers,
employees and any permitted sub-contractors concerned with the Program or the
conduct of work under the Project Plan, but will neither disclose the Confidential
Information to any third party nor use the Confidential Information for any other
purpose. Other provisions of this
Article 7 notwithstanding, a Receiving Party may
disclose to third parties (��Third Party Disclosure��) Confidential Information of the
Disclosing Party as required by law or regulation, provided that the Receiving Party
provides reasonable advance written notice to the Disclosing Party of such Third
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Party Disclosure so that the Disclosing Party may seek a protective order or other
remedy. If the Disclosing Party fails to obtain a protective order or waives
compliance with the relevant provisions of the Agreement, the Receiving Party will
disclose only that portion of the Confidential Information which its legal counsel
determines it is required to disclose.
7.2 The Receiving Party��s obligations of nondisclosure and the limitations upon the
right to use the Confidential Information shall not apply to the extent the receiving
Party can demonstrate the Confidential Information:
7.2.1 is or becomes publicly known through no fault or omission of the
Receiving Party or an Affiliate of the Receiving Party; or
7.2.2 was at the time of receipt already in the possession of the Receiving Party
or an Affiliate of the Receiving Party without obligation of confidentiality
to the Receiving Party; or
7.2.3 was or is received by the Receiving Party or an Affiliate of the Receiving
Party from a third party under no obligation of confidentiality to the
Disclosing Party; or
7.2.4 has been released from such obligation by the prior written consent of the
Disclosing Party; or
7.2.5 is independently developed by or on behalf of the Receiving Party or an
Affiliate of the Receiving Party without the use of the Disclosing Party��s
Confidential Information.
7.3 All obligations relating to the non-disclosure of Confidential Information shall
expire five (5) years from the date of completion or earlier termination for any
reason of the relevant Project.
7.4 Technical Developments will be treated as Confidential Information of the
Party(ies) owning such Technical Developments.
7.5 On expiration or earlier termination of this Agreement, the Receiving Party will, at
the written request of the Disclosing Party, return or destroy (at the Disclosing
Party��s sole discretion) all Confidential Information of the Disclosing Party then in
its possession or control and all copies of it save that the Receiving Party:
7.5.1 may retain a single copy of the Disclosing Party��s Confidential
Information for the sole purpose of ascertaining its ongoing rights and
responsibilities in respect of such information; and
7.5.2
will not be required to surrender or destroy any computer files stored
securely by the Receiving Party, its Affiliates and permitted sub-
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contractors that are created during automatic system back-up or retained
for legal purposes by the legal division of the Receiving Party and its
Affiliates.
7.6 To the extent that either Party provides to the other Party Protected Health
Information (��PHI��) as that term is defined in the Health Insurance Portability and
Accountability act of 1996 and applicable regulations from time to time
promulgated there under (��HIPAA��), both parties shall comply with HIPAA, and to
the extent applicable, the Party obtaining the PHI from any patient or study subject
agrees to obtain a HIPAA authorization or an IRB waiver (or both, as needed or
required) prior to using or disclosing such patients�� or subjects�� PHI to the other
Party. Each Party will only use and disclose PHI in a manner consistent with
HIPAA requirements, and as otherwise may be permitted or required by applicable
law, the subject��s signed authorization or the waiver. Each Party also agrees to use
appropriate safeguards to prevent any unauthorized disclosures of subjects�� PHI.
7.7 Other Sections of this
Article 7 notwithstanding, as part of any disclosure policy
that may be implemented from time to time by Pfizer regarding payments or other
consideration provided to members of the medical or scientific community, or in
accordance with applicable laws or regulations, Pfizer may publicly disclose any
fact related to the content of this Agreement, the name of AMC, the name of any
researcher accepting any form of consideration under this Agreement, as well as the
compensation or consideration provided by Pfizer to AMC hereunder.
8. Intellectual Property Ownership and Patents
8.1 All rights, title and interest in and to any inventions or technologies of AMC or of Pfizer,
respectively, existing on or before the Effective Date, and all rights, title and interest in and to any
inventions or technologies developed by AMC or Pfizer outside the Program hereunder (altogether,
the ��Existing Technologies��) shall be the exclusive property of the respective party.
8.2 Ownership of Technical Developments (and the Patents, if any, which claim such
Technical Developments) shall be determined according to the origin of the
Technical Developments, and, in case of inventions, by inventorship (as defined
under U.S. patent law at the time the invention is made), i.e.:
8.2.1 Shall belong to AMC, if the inventors are one or more employees of AMC
and none of the inventors are employees of Pfizer (��AMC Invention��),
8.2.2 Shall belong jointly to AMC and Pfizer, if the inventors are one or more
employees of AMC and one or more employees of Pfizer ("Joint
Invention"),
8.2.3 Shall belong to Pfizer, if the inventors are one or more employees of
Pfizer and none of the inventors are employees of AMC (��Pfizer
Invention��).
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8.3 AMC and Pfizer will each disclose to the other Party all inventions discovered
under this Agreement and owned by the disclosing Party promptly after becoming
aware of such inventions.
8.4 Patents on AMC Inventions
8.4.1 AMC shall have the right to file patent applications covering any AMC
Invention. AMC shall give Pfizer written notice of its intent to file such
patent applications at least forty-five (45) days in advance of the intended
filing date, and Pfizer shall have the right to review all patent applications
on AMC Inventions and provide AMC with substantive comments. AMC
shall also consult with Pfizer regarding the countries in which such patent
applications should be filed, and AMC will file applications in those
countries where Pfizer requests that AMC should file. AMC, at its option
and at its expense, may file in countries where Pfizer does not request that
AMC should file such applications. AMC shall provide to Pfizer a yearly
update on the status of all such Patents and Patent applications. AMC will
provide to Pfizer forty-five (45) days�� advance written notice of AMC��s
intention to abandon any Patent on a AMC Invention, and Pfizer will have
the right to continue prosecution of such Patent or patent application at
Pfizer��s sole expense.
8.4.2 Pfizer shall reimburse AMC for all costs of filing, prosecuting, responding
to opposition (including interference proceedings), and maintaining
Patents on AMC Inventions in countries where Pfizer requests or agrees
that Patents should be filed, prosecuted and maintained. In the event
Pfizer requests that AMC employ Pfizer's preferred ex-US patent agents in
such countries, AMC shall do so where reasonably possible, and agrees
that Pfizer may be directly invoiced by such agents. Pfizer may, upon
sixty (60) days written notice, request that AMC discontinue filing,
prosecuting, responding to opposition, or maintaining Patents in any such
country and, upon expiration of such sixty (60) day period, discontinue
reimbursing AMC for the costs of filing, prosecuting, responding to
opposition or maintaining such Patent in any country. Subject to the
foregoing, AMC will be free to continue, at its own expense at the end of
such sixty (60) day period, to file, prosecute, respond to opposition and/or
maintain such Patent.
8.5 Patents on Pfizer Inventions. Pfizer shall have the right to file patent applications
covering any Pfizer Invention. Pfizer shall be solely responsible for the prosecution
and maintenance of all Patent applications and Patents claiming Pfizer Inventions
and all costs related thereto.
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8.6 Patents on Joint Inventions.
8.6.1 AMC and Pfizer shall confer regarding the filing of patent applications on
Joint Inventions. Pfizer shall have the right to file patent applications
covering any Joint Invention using outside counsel reasonably acceptable
to both Parties. AMC agrees that Pfizer may employ its preferred ex-US
patent agents for such filing, and otherwise employ all reasonable cost-
savings measures. Pfizer shall give AMC notice of its intent to file any
patent application at least sixty (60) days in advance of its filing date.
AMC shall have the right to review all patent applications on Joint
Inventions and to provide Pfizer with substantive comments. Pfizer will
notify AMC of its intention to abandon any Patent on a Joint Invention
and AMC will have right to continue prosecution of such Patent at AMC��s
sole expense. Subject to the preceding sentence and to
Section 8.6.3,
Pfizer shall be solely responsible for filing, prosecuting, responding to
oppositions (including interference proceedings) and maintaining all
Patents claiming Joint Inventions and all costs related thereto. Subject to
the grant of licenses herein and the exercise of the option under
Section
9.2, each Party shall be free to exploit, either itself or through the grant of
licenses to Third Parties (which Third Party licenses may be further
sublicensed), rights in any Joint Inventions, including any patents directed
thereto, throughout the world without restriction, without the need to
obtain further consent from or provide notice to the other party, and
without any duty to account or otherwise make any payment of any
compensation to the other party.
8.6.2 Pfizer shall consult with AMC regarding the countries in which patent
applications claiming Joint Inventions should be filed, and Pfizer will file
applications in those additional countries where AMC requests Pfizer to
do so. Pfizer, at its option and at its expense, may initially select the list of
countries in which to file, and may file in countries where AMC does not
request that Pfizer file such Patent applications.
8.6.3 AMC shall reimburse Pfizer for all costs of filing, prosecuting, responding
to opposition (including interference proceedings), and maintaining Patent
applications and Patents on Joint Inventions filed under
Section 8.6.2 in
additional countries where AMC requests that Patent applications be filed,
prosecuted and maintained. AMC may, upon sixty (60) days written
notice, request that Pfizer discontinue filing, prosecuting, responding to
opposition, or maintaining Patent applications or Patents in any such
country and, upon expiration of such sixty (60) day period, may
discontinue reimbursing Pfizer for the costs of filing, prosecuting,
responding to opposition or maintaining such Patent application or Patent
in any country. Subject to the foregoing, Pfizer will be free to continue, at
its own expense at the end of such sixty (60) day period, to file, prosecute,
respond to opposition and/or maintain such Patent application or Patent.
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8.6.4 Patents on Joint Inventions after Pfizer Declines to Exercise Option. In
the event that Pfizer declines to exercise its option to acquire a worldwide-
royalty-bearing, exclusive license to a Joint Invention under
Section 9.2,
or such option expires without Pfizer having acquired such a license under
the Option, then AMC shall have the right, but not the obligation, to file
patent applications covering such Joint Invention, exercisable at AMC��s
sole election; in such circumstances, if AMC proceeds with patenting Joint
Inventions, Pfizer shall retain any rights it may have as a joint owner
under existing law.
8.7 Each Party undertakes on behalf of itself, its directors, officers, employees,
Affiliates and permitted subcontractors to do such further acts and execute such
documents as may be reasonably necessary to give effect to each Party��s rights
under this
Article 8.
8.8 AMC will have such policies and procedures in place so as to cause all personnel
affiliated with AMC (including permitted students and subcontractors used by
AMC), including the Program Contact and AMC��s members of the Program
Advisory Committee, to vest all Technical Development and Patents created by
such AMC personnel in the name of AMC.
8.9 It is understood with respect to patent filing, prosecution or maintenance activities
conducted by Pfizer with respect to any Joint Inventions arising under this
agreement, that Pfizer represents only itself, and not AMC, and that AMC is
represented by its own counsel. Neither Pfizer, nor any of its Affiliates or sub-
licensees, nor any of their employees or agents shall be liable for any act or
omission with respect to such activities.
9. Licenses
9.1 Research and Educational Licenses.
9.1.1 AMC grants to Pfizer and Pfizer��s Affiliates a non-exclusive, world-wide,
perpetual, non-cancelable, royalty-free, fully paid-up license under AMC��s
rights in Technical Developments, including its rights in AMC Inventions
and Patents covering such AMC Inventions, to use the Technical
Developments for internal research and development purposes only. The
foregoing license shall be without the right to transfer or grant sublicenses
to any third party (except to contractors performing work solely for the
benefit of Pfizer or Pfizer��s Affiliates and under obligations of
confidentiality and non-use similar to those of this Agreement), unless
Pfizer receives the express written permission of AMC to do so.
9.1.2 Pfizer grants to AMC and AMC��s Affiliates a non-exclusive, world-wide,
perpetual, non-cancelable, royalty-free, fully paid-up license under
Page 14 of 28
Pfizer��s rights in Technical Developments, including its rights in Pfizer
Inventions and Patents covering such Pfizer Inventions, to use the
Technical Developments for internal research and educational purposes
only, which shall include collaborations between AMC and other non-
profit and government entities. The foregoing license shall be without the
right to transfer or grant sublicenses to any third party (except to
contractors performing work solely for the benefit of AMC or AMC��s
Affiliates and under obligations of confidentiality and non-use similar to
those of this Agreement), unless AMC receives the express written
permission of Pfizer. Collaborations with for-profit entities are expressly
excluded from the license granted in this
Section 9.1.2.
9.1.3 Pfizer grants to AMC and AMC��s Affiliates a non-exclusive, world-wide,
royalty-free, fully-paid license (without the right to transfer or grant
sublicenses) during the Term under Pfizer��s rights in Materials provided
by Pfizer to AMC under the Program to use such Materials under the
Program. This license includes the right to sublicense only to contractors
doing work for the benefit of AMC or AMC��s Affiliates under the
Program.
9.1.4 AMC grants to Pfizer and Pfizer��s Affiliates a non-exclusive, world-wide,
royalty-free, fully-paid license (without the right to transfer or grant
sublicenses) during the Term under AMC��s rights in Materials provided
by AMC to Pfizer under the Program to use such Materials under the
Program. This license includes the right to sublicense only to contractors
doing work for the benefit of Pfizer or Pfizer��s Affiliates under the
Program.
9.2 Commercial Option and Licenses
9.2.1 AMC hereby grants to Pfizer the exclusive option to acquire (i) a
worldwide, royalty-bearing, exclusive or non-exclusive license, including
the right to grant sublicenses under an exclusive commercial license, to
make, use, sell, offer for sale, import and export Products, under all of
AMC��s right, title and interest in AMC Technical Developments, AMC
Inventions and AMC��s interest in Joint Inventions, including Patents
covering any of the foregoing which arise from the work performed under
that Project Plan and (ii) the associated investigational new drug
application (the ��IND Application��) (each, an ��Option��)
. Pfizer and its
Affiliates must exercise the Option by providing written notice to AMC
within six (6) months after written notification by AMC to Pfizer of the
corresponding Technical Development or Invention or within six (6)
months of completion of the Project Plan under which the Technical
Development or Invention arose, whichever is later,
provided, however,
that if AMC gives notice to Pfizer of its intent to file a patent application
under
Section 8.4.1 and if Pfizer does not request AMC to file the patent
Page 15 of 28
application in any specific countries, then the Option will expire six (6)
months from the date AMC first notifies Pfizer of AMC��s intent to file the
patent application. Pfizer��s failure to timely exercise such option shall
cause such option to lapse and expire.
9.2.2 Consideration terms for any license elected pursuant to the Option shall
specifically include, but will not be limited to, provisions that:
[Specific financial terms mutually agreeable to the Parties to be inserted
here].
9.2.3 If the Parties do not agree upon an exclusive license to any AMC
Invention or AMC Technical Developments in accordance with
Section
9.2 by the end of the fifth (5th) month after the election by Pfizer of the
Option, AMC may license its interests in such AMC Invention or AMC
Technical Developments to any third party on any terms it desires, in its
sole discretion. Such licenses shall not include rights to Pfizer solely-
owned intellectual property or Pfizer Confidential Information. Provided,
however, that if AMC believes that the consideration specified as payable
by Pfizer for the grant of any right to Pfizer on its exercise of any option,
is less than the then fair market value for such grant of rights, determined
at the time of option exercise, AMC may so notify Pfizer within ten (10)
days of Pfizer��s exercise, and Pfizer and AMC shall negotiate in good
faith for a period not to exceed three (3) months from the date of Pfizer��s
exercise plus any extensions of time as agreed by the Parties (altogether,
the ��Negotiation Period��) to reach agreement on revised consideration
representing such fair market value. If the Parties have not reached
agreement on revised consideration by the end of the second (2nd) month
of the Negotiation Period, then each Party shall at that time refer further
negotiations to a member of its senior management selected by that Party
(each, a ��Senior Negotiator��). For AMC, the initial Senior Negotiator
shall be the Vice Chancellor of Research or an equivalent position. For
Pfizer the initial Senior Negotiator shall be the [Insert appropriate
position]. The Senior Negotiators shall continue negotiations on the terms
of the license agreement for a period of up to one (1) month (i.e., the third
(3rd) month of the Negotiation Period). If the Senior Negotiators have not
reached agreement on revised consideration by the end of the Negotiation
Period, each Party shall submit its final proposed consideration. Fair
market value consideration (which shall not be less than final proposal by
Pfizer or greater than the final proposal by AMC) shall be determined by
arbitration in accordance with the procedures of the American Arbitration
Association (��AAA��). Each Party shall bear its own costs of the
arbitration. On determination of such fair market value consideration,
Pfizer shall have the right to enter into the proposed license on the basis of
such revised consideration or to rescind the exercise of its option. If Pfizer
rescinds the exercise of its option, then (i) the option will immediately
Page 16 of 28
lapse and expire, and (ii) AMC will be free to license the subject AMC
Technical Developments, AMC Inventions or AMC��s interest in Joint
Inventions to any third party or parties as AMC desires.
9.3 Additional License Terms.
9.3.1 Each exclusive license agreement granting rights from AMC to Pfizer and
which results from Pfizer��s exercise of the Option will contain a provision
requiring Pfizer to use Commercially Reasonable Efforts to commercialize a
Product or a service (as applicable) in the United States and other countries if
mutually agreed to by AMC and Pfizer.
9.3.2 Any license granted to Pfizer for inventions covering diagnostic research tools
which results from the exercise of any Option will be non-exclusive.
9.3.3 AMC will have the right under all circumstances to grant a license for AMC
Technical Developments to not-for-profit research institutions and the United
States Government to use AMC Technical Developments for research and
teaching purposes only and not for use in the manufacture, distribution or sale
of products. Nothing herein shall affect the United States Government��s
rights under the Bayh Dole Act, including the Government license under 35
U.S.C. �� 202.
10. Indemnification
10.1 Pfizer agrees to hold harmless, indemnify and defend AMC from all third party
liabilities, demands, damages, expenses and losses arising out of: (i) use by Pfizer
or by any third party acting on behalf of or under authorization from Pfizer, of
information or materials received from AMC, or (ii) any use, sale or other
disposition by Pfizer or by any third party acting on behalf of or under authorization
from Pfizer of products made by use of information or materials received from
AMC; provided, however, that the foregoing shall not apply (i) if the claim is
found to be based upon the negligence, recklessness or willful misconduct of AMC
or (ii) if AMC fails to give Pfizer prompt notice of any claim it receives and such
failure materially prejudices Pfizer with respect to any claim or action which
Pfizer��s obligation pursuant to this Section applies. Pfizer, in its sole discretion,
shall choose legal counsel, shall control the defense of such claim or action and
shall have the right to settle same on such terms and conditions it deems advisable.
10.2 No Warranty. ANY INFORMATION, RESULTS, MATERIALS, SERVICES,
RESOURCES, INTELLECTUAL PROPERTY OR OTHER PROPERTY OR
RIGHTS GRANTED, GRANTED ACCESS TO, OR PROVIDED BY PFIZER TO
AMC PURSUANT TO THIS AGREEMENT (HEREIN THE ��INTELLECTUAL
PROPERTY��) ARE ON AN ��AS IS�� BASIS. PFIZER MAKES NO
WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, AS TO
ANY MATTER INCLUDING, BUT NOT LIMITED TO, WARRANTY OF
Page 17 of 28
FITNESS FOR PARTICULAR PURPOSE, MERCHANTABILITY,
EXCLUSIVITY, ACCURACY, INTEGRATION, OR RESULTS OBTAINED
FROM INTELLECTUAL PROPERTY, INCLUDING BUT NOT LIMITED TO,
ANY USE OF ANY INTELLECTUAL PROPERTY MADE OR CREATED
UNDER THE AGREEMENT, NOR SHALL PFIZER BE LIABLE TO AMC FOR
INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES INCLUDING, BUT
NOT LIMITED TO, LOSS OF PROFITS OR INABILITY TO USE, USE
PROPERLY, OR USE WITHOUT ERRORS, SAID INTELLECTUAL
PROPERTY OR ANY APPLICATIONS AND DERIVATIONS THEREOF.
PFIZER MAKES NO WARRANTIES OF ANY KIND WITH RESPECT TO
FREEDOM FROM PATENT, TRADEMARK, OR COPYRIGHT
INFRINGEMENT, INFORMATIONAL CONTENT, ACCURACY,
INTEGRATION, OR THEFT OF TRADE SECRETS AND DOES NOT ASSUME
ANY LIABILITY HEREUNDER FOR ANY INFRINGEMENT OF ANY
PATENT, TRADEMARK, OR COPYRIGHT ARISING FROM THE USE OF
THE INTELLECTUAL PROPERTY OR RIGHTS GRANTED OR PROVIDED
BY IT HEREUNDER. AMC AGREES THAT IT WILL NOT MAKE ANY
WARRANTY ON BEHALF OF PFIZER EXPRESSED OR IMPLIED, TO ANY
PERSON CONCERNING THE APPLICATION OF, ACCURACY OF, OR THE
RESULTS TO BE OBTAINED WITH THE INTELLECTUAL PROPERTY, OR
WITH RESPECT TO ANY OTHER MATTER
11. Publication
11.1 The Parties acknowledge that inadvertent publication of the results arising under
any Project Plan may jeopardize patent protection. Notwithstanding the foregoing,
Pfizer acknowledges the importance of publications to the reputation of AMC and
its faculty members. The provisions of this
Section 11 are intended to promote and
ensure timely publication of results of Projects, inventions and Technical
Developments, while protecting patent rights and Confidential Information.
11.2 In the event AMC wants to publish or present any or all of the Technical
Developments, it shall submit to Pfizer the manuscript, abstract or other proposed
publication at least thirty (30) days prior to submission and, in the case of poster
boards or other presentations, at least thirty (30) days prior to the presentation itself
(the ��Initial Review Period��). Pfizer shall timely review the proposed publication,
and may, together with AMC, revise the manuscript or other proposed publication
to ensure protection of Pfizer��s Confidential Information. Upon Pfizer��s request,
AMC shall delay submission or publication for up to an additional thirty (30) days
(the ��Supplemental Review Period��) if Pfizer deems it reasonably necessary to
enable AMC or Pfizer (as the case may be) to apply for Patent protection covering
any Technical Development disclosed in the proposed publication. In exercising its
rights under this Section, Pfizer will not unreasonably withhold or delay consent.
Page 18 of 28
12. Termination
12.1 AMC may suspend or terminate all or any portion of any human subject research
that it is conducting upon written notice to Pfizer if AMC determines in its
reasonable discretion that such action is necessary for patient safety or in the
event any approval required by the IRB, the FDA, the NIH or any other federal or
state agency is terminated, expired, withdrawn or suspended. Either Party may
suspend or terminate all or any portion of any human subject research that is
being conducted by AMC under the Project Plan upon written notice to AMC if
the Party determines in its reasonable discretion that such action is necessary for
patient safety.
12.2 Either Party may terminate this Agreement:
12.2.1 if the other Party commits a material breach of a material term of this
Agreement which, if capable of remedy, remains unremedied by the
breaching Party for sixty (60) days following written requirement by the
non-breaching Party to the breaching Party to cure the same; or
12.2.2 if the other Party becomes insolvent, the subject of bankruptcy
proceedings, enters into an arrangement with its creditors, or any
circumstance analogous to the foregoing; or
12.2.3 at will and for any reason upon delivery to the other Party sixty (60)
days advance written notice of such termination.
12.3 Effect of Termination.
12.3.1 If this Agreement is terminated by AMC under
Section 12.2.1 or by Pfizer
under
Section 12.2.3, then any license granted to Pfizer under
Article 9.2
will terminate upon the effective date of such Agreement termination,
provided, however, that Pfizer will be allowed to sell all inventory of
Product then in its possession or distribution pipeline. Upon such
termination, rights in the AMC Inventions and AMC Technical
Developments which were the subject of the license will revert to AMC.
In the event that AMC declares that it will not exercise its right to
commercialize or license its interests in such AMC Invention or AMC
Technical Developments to any third party, then AMC, to the extent it is
legally able, will grant to NIH a license (with right to sublicense) to make,
use, sell, offer for sale, import and export such AMC Invention or AMC
Technical Developments.
12.3.1 If this Agreement is terminated by Pfizer under
Section 12.2.1 or by AMC
under
Section 12.2.3, then any license granted to Pfizer under
Article 9.2
will become perpetual and irrevocable.
Page 19 of 28
12.4 The following Articles and Sections shall survive the expiration or termination for
any reason of this Agreement:
Articles 2, 7, 8, 9, 10, 11, and
13; and
Sections
5.2, 12.3, 12.4, 15.1, 15.4, 15.6, 15.7, 15.8, 15.9, 15.10, 15.11, and
15.12.
13. Representations and Warranties
13.1 Each Party warrants that the activities conducted by such Party under this
Agreement shall conform to the specifications and the current material applicable
standards, laws, regulations, recognized ethical standards, and procedures of the
appropriate regulatory and oversight agencies.
13.2 Each Party represents that it has the right, authority and necessary licenses to
enter into and perform its obligations under this Agreement in accordance with all
applicable governmental laws, rules and regulations.
13.3 Each Party certifies that it is not debarred under subsections 306(a) or (b) of the
Federal Food, Drug, and Cosmetic Act and will not use in any capacity the services
of any person debarred under such law with respect to services to be performed
under this Agreement.
13.4 AMC warrants that it will conduct all work involving animals with standards
consistent with those used by The Association for Assessment and Accreditation
of Laboratory Animal Care International (AAALAC International). In addition,
AMC will observe any and all statutes and applicable governmental regulations
that bear upon animal welfare, care and use of the jurisdiction(s) in which AMC��s
facilities are located.
14. Monitoring and Audits
14.1 Upon reasonable notice and during regular business hours, AMC will permit
Pfizer representatives access to the premises, facilities, study records,
investigators, and research staff employed in connection with and Project Plan as
required to monitor study conduct and/or animal care and welfare. Monitoring by
Pfizer does not relieve AMC of any of its obligations under this Agreement.
14.2 The work performed under this Agreement may be subject to inspection by
regulatory agencies worldwide, including, without limitation, the FDA and
USDA. Regulatory inspections may occur after completion of the Program and
may include auditing of study records.
14.2.1 Notification. AMC will notify Pfizer as soon as reasonably possible if the
site is inspected or scheduled to be inspected by a regulatory agency in
relation to the Program. If AMC has reasonable advance notice of an
inspection which involves a Pfizer Compound, Pfizer will have a right to
participate in the inspection.
Page 20 of 28
14.2.2 Cooperation. AMC will cooperate with regulatory agency or Pfizer
representatives in the conduct of inspections and audits and will ensure
that study records are maintained in a way that facilitates such activities.
14.2.3 Resolution of Discrepancies. AMC will promptly resolve any
discrepancies that are identified between study data and source
documentation, or deviations from animal care and use standards.
14.2.4 Inspection Findings and Responses. AMC will promptly forward to Pfizer
copies of any inspection findings (e.g. Establishment Inspection Report,
FDA Form 483 or USDA Inspection Report) that it receives from any
regulatory agency in relation to the Program. Whenever feasible, AMC
will also provide Pfizer with an opportunity to prospectively review and
comment on AMC��s responses to regulatory agency inspections in regard
to the Program.
14.2.5 Animal Care & Welfare Inspections. AMC will promptly forward to
Pfizer copies of any inspection findings or notices that AMC receives
from AAALAC International or any regulatory agency in relation to the
animal care and use program at AMC��s facilities that occurs at any time
during the term of this Agreement.
14.3 Additional monitoring and auditing requirements are stated in
Exhibit B.
15. General Provisions
15.1 Notices. Notices to be given under this Agreement shall be in writing and sent to
the Parties as follows:
If to Pfizer, to:
[INSERT CONTACT AND ADDRESS]
With copy to:
If to AMC, to:
[INSERT CONTACT AND ADDRESS]
With copy to:
[INSERT CONTACT AND ADDRESS]
Any such notice will be validly given if delivered in person, by certified mail,
return receipt requested, by courier or by confirmed facsimile transmission, and
shall be deemed effective on receipt.
15.2 Contingent upon Execution of Grant Agreement. This Agreement will not be in
force and effect until such time as AMC and NIH have executed the NIH Grant
and received concurrence from NIH that the terms and conditions of this
Page 21 of 28
Agreement are consistent with NIH policies. Changes to any terms or conditions
of this Agreement or to the Project Plan which are requested by NIH during the
review process must be approved by Pfizer and AMC in writing before they are
effective.
15.3 Execution in Counterparts. This Agreement may be executed in two counterparts
(including by facsimile or electronic copies), each of which shall be deemed an
original, and both of which together shall constitute one and the same instrument.
15.4 No Waiver. No waiver is made or given unless in writing and signed on behalf of
the Party making such waiver. Any waiver granted on one occasion shall not be
deemed a waiver given on any other or subsequent occasion. All rights of the
Parties are cumulative.
15.5 Assignment. Neither Party may assign this Agreement in whole or in part without
the prior written consent of the other Party, save that Pfizer may make such
assignment to any Affiliate or may make such assignment in the event of any
acquisition, merger or other valid business reconstruction without such consent of
AMC.
15.6 Independent Entities. Each Party acknowledges that it is entering into this
Agreement solely on its own behalf, and will perform any and all of its
obligations or work under this Agreement as an independent entity. Nothing under
this Agreement shall create any other relationship between the Parties including
without limitation one of principal and agent, employer and employee, or
partnership.
15.7 Entire Agreement. This Agreement incorporates all Exhibits and constitutes the
entire agreement and understanding between the Parties in respect of the subject
matter hereof and replaces in its entirety any prior discussions, negotiations,
agreements or other arrangements in relation to the subject matter, whether
written or oral, all of which are replaced by the terms of this Agreement. No
amendment or modification of this Agreement shall be valid or binding unless
made in writing and signed by authorized representatives of both parties.
15.8 Use of Names. Subject to
Section 7.7, except as required by law or by NIH for its
public databases on awards, such as RePORT, neither Party may use the name of
the other Party in any public announcement, advertising, or other public
disclosure without first gaining the written consent of the other Party.
15.9 Severability. When possible, each provision of this Agreement will be interpreted
in such manner as to be effective, valid, and enforceable under applicable law, but
if any provision of this Agreement is held to be invalid or unenforceable under
applicable law, such provision will be held invalid or unenforceable without
invalidating the remainder of such provision or of this Agreement. The Parties
will make a good faith effort to replace the invalid or unenforceable provision
Page 22 of 28
with a valid one, which in its economic effect is most consistent with the invalid
or unenforceable provision.
15.10 Authorized Representatives. The signatories to this Agreement confirm that they
are authorized by their respective organizations to enter into this Agreement. Both
Pfizer and AMC represent and warrant to each other that they will perform this
Agreement in compliance with all applicable laws, ordinances and regulations by
which they are bound and in so doing they will not to the best of their knowledge
breach the terms of any other agreement to which they are a party.
15.11 Choice of Law. This Agreement shall be governed in all respects by the laws of
the State of [insert].
15.12 Consultancy. Both Parties agree that each is responsible for the acts of its own
employees within the scope of their employment pursuant to all relevant and
applicable laws and regulations. Notwithstanding the above, Pfizer agrees that in
the event a AMC faculty or staff member serves Pfizer in the capacity of
consultant, officer, employee, board member, advisor, or other designation,
pursuant to a contract or otherwise outside of this Agreement, when acting outside
of this Agreement such AMC faculty or staff member shall serve in his or her
individual capacity, as an independent contractor, and not as an agent or
representative of AMC, that AMC exercises no authority or control over such
faculty or staff member while acting in such capacity, that AMC receives no
benefit from such activity, that neither Pfizer nor the faculty or staff member may
use AMC resources in the course of such service and that AMC makes no
representations or warranties under such contracts and otherwise assumes no
liability or obligation in connection with any such work or service undertaken by
such faculty or staff member. Pfizer further agrees that any breach, error, or
omission by a AMC faculty or staff member acting in the capacity set forth above
in this Section shall not be imputed or otherwise attributed to AMC, and shall not
constitute a breach of this Agreement by AMC.
Page 23 of 28
IN WITNESS WHEREOF the Parties have caused this Agreement to be executed by
the hands of their duly appointed representatives on the Effective Date.
[Academic Medical Center]
Pfizer Inc.
Signed:
����������������������. Signed:
��������������������..
Printed Name:
Printed Name:
Position:
Position:
Date:
����������������������. Date:
��������������.............
Signed:
��������������������..
Printed Name: ��������������������..
Position: ��������������������������.
Date: ������.��������������������..
Page 24 of 28
Exhibit A – Project Plan
N.b.: The Project Plan will include at least the following:
• Descriptive Title
• List of Key Contributors
• Statement of the Hypothesis for the Mechanism (target) and Indication
• Background Information that Support and Refute the Hypothesis
• Target Product Profile – What specific patients will benefit? How exactly will
they benefit? How this will be notably superior to what is now or soon to be
available to them? Number of such patients in US? Number of new cases?
Current therapy options (rough cost of each)?
• Detailed Plan for Validating the Indication/Target Pair Hypothesis
o Specific Aims – including rationale and ��Go / No Go�� decision criteria for:
▪ Preclinical Studies – if needed
▪ Clinical Study
o Justification for the Decision Criteria
o Assessment of operational feasibility and resources needed for execution
o Capabilities of the relevant labs/groups – evidence that the decisive studies
can be performed by the key contributors
• Specific Success Criteria
• Project Advisory Committee Composition (the Pfizer Contact, AMC Contact and
any additional PAC members in accordance with Section 4.1 of the Agreement)
• Appendix 1: Overall Project Decision Tree – with criteria for each decision
• Appendix 2: Clinical Study Outline
• Appendix 3: Budget – aligned with Specific Aims and milestones (decision
points) in the Project Decision Tree
• Appendix 4: Proposed Timelines and Milestones
• Appendix 5: NIH Biosketch of the Principal Investigator(s)
Page 25 of 28
Exhibit B – IIR Agreement Template
Page 26 of 28
Exhibit C1 – Proforma for Transfer from One Party to the Other of Materials,
Reagents and Any Other Physical Property Not Derived from Human Tissue
To be completed by AMC��s Program Contact and signed by both AMC��s Program
Contact and Pfizer��s Program Contact
Transfer #:
[insert unique number assigned by AMC��s Program Contact]
Transferor:
[insert the name of the Party transferring items to the other
Party (either Pfizer or AMC as the case may be)]
Transferee:
[insert the name of the Party receiving items from the other
Party (either AMC or Pfizer as the case may be)]
AMC contact
Person:
[insert name of individual]
Pfizer contact
Person:
[insert name of individual]
Items to be transferred: [insert a detailed description of items to be transferred]
Purpose of transfer:
[insert a detailed description of why the transfer is taking
place]
Date of transfer:
[insert the effective date of the transfer]
Applicable Terms:
This transfer is governed by the terms and conditions of the
Collaborative Research Agreement between Pfizer and [AMC]
dated [insert date].
Agreed and accepted by the Program Contacts on behalf of:
Academic Medical Center
Pfizer Inc.
Signed:
����������������������..
Print name: ����������������������..
Date:
����������������������..
Signed:
��������������������.
Print name: ��������������������.
Date:
��������������������..
Page 27 of 28
Exhibit C2 – Proforma for Transfer from One Party to the Other of Materials,
Reagents and Any Other Physical Property Derived from Human Tissue
To be completed by AMC��s Program Contact and signed by both AMC��s Program
Contact and Pfizer��s Program Contact
Transfer #:
[insert unique number assigned by AMC��s Program Contact]
Transferor:
[insert the name of the Party transferring items to the other
Party (either Pfizer or AMC as the case may be)]
Transferee:
[insert the name of the Party receiving items from the other
Party (either AMC or Pfizer as the case may be)]
AMC contact
Person:
[insert name of individual]
Pfizer contact
Person:
[insert name of individual]
Items to be transferred: [insert a detailed description of items to be transferred]
Transferor represents and warrants that all applicable laws,
regulations and governmental guidelines were complied with in
the collection and handling of the Material; that collection of
the Material was approved by either an Institutional Review
Board (��IRB��) or included in an open IND that complies with
applicable federal regulations for such a body; that an informed
consent (��Informed Consent��) was obtained from each donor;
that the transfer of Material from the Transferor to the
Transferee and the uses described in this Proforma are
consistent with and within the scope of either the IRB approval
or IND and Informed Consent; and the that Transferor has the
legal right to provide the Materials and is not infringing on the
property rights of any third party. The Transferor will provide
the Transferee with a copy of the language of the informed
consent documents, if necessary.
Purpose of transfer:
[insert a detailed description of why the transfer is taking
place]
Date of transfer:
[insert the effective date of the transfer]
Page 28 of 28
Applicable Terms:
This transfer is governed by the terms and conditions of the
Collaborative Research Agreement between Pfizer and [AMC]
dated [insert date].
Agreed and accepted by the Program Contacts on behalf of:
Academic Medical Center
Signed:
����������������������..
Print name: ����������������������..
Date:
����������������������..
Pfizer Inc.
Signed:
��������������������.
Print name: ��������������������.
Date:
��������������������..
