[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

Exhibit 10.2
CLINICAL TRIAL COLLABORATION AGREEMENT
This CLINICAL TRIAL COLLABORATION AGREEMENT (the “Agreement”) is made and
entered into effective as of February 24, 2017 (the “Effective Date”) by and
between Exelixis, Inc., a Delaware corporation, located at 210 East Grand
Avenue, South San Francisco, CA 94080 (“Exelixis”) and Bristol-Myers Squibb
Company, a Delaware corporation, headquartered at 345 Park Avenue, New York, New
York 10154 (“BMS”). Exelixis and BMS may be referred to herein individually as a
“Party,” or collectively as the “Parties.”

RECITALS
    WHEREAS, the Parties wish to collaborate with each other to sponsor one or
more clinical trials of a combination therapy using Exelixis’s tyrosine kinase
inhibitor known as “Cabozantinib”, certain rights to which are licensed by
Exelixis to, and shared by Exelixis with Ipsen Pharma SAS (“Ipsen”) and Takeda
Pharmaceutical Company Ltd. (“Takeda”), and BMS’ human monoclonal antibody that
binds PD-1 known as “Nivolumab”, certain rights to which are licensed by BMS
from, and shared by BMS with, Ono Pharmaceutical Co. Ltd. (“Ono”), with or
without BMS’s CTLA-4 monoclonal antibody known as “Ipilimumab”.
    NOW, THEREFORE, in consideration of the foregoing premises and the mutual
promises and covenants contained herein, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
The terms in this Agreement with initial letters capitalized, whether used in
the singular or the plural, shall have the meaning set forth below or, if not
listed below, the meaning designated in places throughout this Agreement.
1.1     “Affiliates” shall mean, with respect to a particular Party, an entity
that, directly or indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with such Party. As used in this
section, the term “controls” (with correlative meanings for the terms
“controlled by” or “under common control with”) means (a) that an entity or
company owns, directly or indirectly, more than fifty percent (50%) of the
voting stock of another entity, or (b) that an entity, person or group otherwise
has the actual ability to control and direct the management of the entity,
whether by contract or otherwise.
1.2    “Aggregate Safety Information” shall mean, with respect to a Party's
Compound(s), the (a) safety and toxicity information for such Compound(s) that
is Combined Therapy Study Data, plus (b) safety and toxicity information from
all other clinical trials of such Compound(s), whether alone or in combination
with another pharmaceutical agent, in each case including information related to
serious adverse events, adverse drug reactions, adverse events,

1

    

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discontinuations due to adverse events and Grade 3 and Grade 4 laboratory
abnormalities. Aggregate Safety Information shall be provided by a Party to the
other in the same format as is contained in the Investigators’ Brochures
prepared by such Party for its Compound(s) in each country where a Combined
Therapy Trial will be conducted.
1.3    “Agreement” shall have the meaning set forth in the preamble to this
Agreement, as it may be amended by the Parties from time to time.
1.4    “Applicable Law” shall mean all applicable laws, rules and regulations
(whether federal, state or local) that may be in effect from time to time and
applicable to conduct under this Agreement, including current Good Clinical
Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing
Practices (GMP).
1.5    “Arbitration Matter” shall mean any disputed matter that relates to or
arises out of the validity, interpretation or construction of, or the compliance
with or breach of, this Agreement; provided that such disputed matter has been
considered, but not resolved, by the Executive Officers as set forth in Section
13.3. For clarity, no JDC Dispute (other than a dispute relating to the above
matters which is raised at the JDC), Publication Dispute, or any matter
requiring mutual agreement of both Parties shall be an Arbitration Matter.
1.6    “Bioanalysis Plan” shall mean the bioanalysis plan for any Samples as may
be contemplated by a Combined Therapy Trial Protocol or another subsequent
written agreement between the Parties, as described in Section 8.5.
1.7    “BMS” shall have the meaning set forth in the preamble to this Agreement.

1.8    “BMS Compound” shall mean each of BMS’s proprietary anti-PD-1 monoclonal
antibody known as Nivolumab and BMS’s proprietary CTLA-4 monoclonal antibody
known as Ipilimumab. In the event that any provision of this Agreement refers to
the BMS Compound(s) or to Compound(s) of BMS or otherwise imposes an obligation
on, or grants a right to, BMS in relation to such Compound(s), this provision
will be read to relate to Nivolumab alone, to Ipilimumab alone or to both of
them jointly, as is required in order to give full effect to such provision.

1.9    “BMS Indemnitees” shall have the meaning set forth in Section 11.2 of
this Agreement.
1.10    “BMS Independent Patent Rights” shall mean any Patent Rights Controlled
by BMS (or its Affiliates) as of the Effective Date or during the Term through
efforts outside of this Agreement that Cover the use (whether alone or in
combination with other agents), manufacture, formulation or composition of
matter of each of the BMS Compounds, but excluding any BMS Study Patent Rights
and BMS’ interest in any Combined Therapy Patent Right.

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1.11    “BMS Regulatory Documentation” shall mean any Regulatory Documentation
related to the BMS Compounds that exists as of the Effective Date or that is
created during the Term through efforts outside this Agreement.
1.12    “BMS Study Data” shall have the meaning set forth in Section 8.2 of this
Agreement.
1.13    “BMS Study Invention” shall mean any Invention that relates to (a) the
composition of matter of any BMS Compound (and not the Exelixis Compound), (b) a
method of manufacture or formulation of any BMS Compound (and not the Exelixis
Compound) as a Single Agent, (c) a method of use of any BMS Compound as a
monotherapy or as used in combination with agents, antibodies or compounds that
are not the Exelixis Compound.
1.14    “BMS Study Patent Rights” shall mean any Patent Rights that Cover any
BMS Study Invention (and not an Exelixis Study Invention or Combined Therapy
Invention) or BMS Study Data, excluding BMS Independent Patent Rights and BMS
Technology. For the avoidance of doubt, any Patent Rights that Cover both (x) a
BMS Study Invention and (y) any other type of Invention is included within the
Combined Therapy Patent Rights.
1.15    “BMS Technology” shall mean all Technology Controlled by BMS (or its
Affiliates) as of the Effective Date or during the Term through efforts outside
of this Agreement related to the BMS Compound(s) or the Combined Therapy and
necessary for the conduct of the Combined Therapy Trials. For clarity, BMS
Technology does not include (a) Inventions, (b) Study Data, or (c) Combined
Therapy Trial Regulatory Documentation.
1.16    “Business Day” shall mean a day other than Saturday, Sunday or any day
on which commercial banks located in New York, NY are authorized or obligated by
Applicable Law to close.
1.17    “Clinical Hold” shall mean that (i) the FDA has issued an order to a
Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or
to suspend an ongoing clinical investigation of the Combined Therapy or such
Party’s Single Agent Compound(s) in the United States or (ii) a Regulatory
Authority other than the FDA has issued an equivalent order to the order in (i)
in any other country or group of countries.
1.18    “Combined Therapy” shall mean a therapy using the Exelixis Compound on
the one hand and a BMS Compound or the BMS Compounds on the other hand, only
when used in combination, wherein each compound of the combination is used as an
individual formulation, for use in the Field, with or without another agent.
1.19    “Combined Therapy IND” shall have the meaning set forth in Section
2.1(b).
1.20    “Combined Therapy Invention(s)” shall mean all Inventions that are not
Exelixis Study Inventions or BMS Study Inventions. For the avoidance of doubt,
Combination Therapy Inventions include any Invention comprising or claiming,
whether generically or specifically, (a) one or both of the BMS Compounds and/or
any other molecule(s) that is/are designed to selectively

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bind to PD-1 or PD-L1 or CTLA-4 and (b) the Exelixis Compound and/or any other
molecule(s) that is/are designed to selectively inhibit the activity of MET,
VEGF receptors, AXL and RET.
1.21    “Combined Therapy Patent Right(s)” shall mean any Patent Rights that
Cover any Combined Therapy Invention or Combined Therapy Study Data, excluding
BMS Independent Patent Rights and Exelixis Independent Patent Rights.
1.22    “Combined Therapy Study Data” shall have the meaning set forth in
Section 8.2 of this Agreement.
1.23    “Combined Therapy Trial” or “Combined Therapy Trials” shall have the
meaning set forth in Section 2.1(a) of this Agreement.
1.24    “Combined Therapy Trial Regulatory Documentation” shall mean any
Regulatory Documentation to be submitted for the conduct of a Combined Therapy
Trial, but excluding (a) any Exelixis Regulatory Documentation and (b) any BMS
Regulatory Documentation.
1.25    “Commercially Reasonable Efforts” means the level of effort and
resources normally devoted by a Party to conduct a clinical trial for a
biopharmaceutical product or compound that is owned by it or to which it has
rights, which is of similar market potential, profit potential or strategic
value and at a similar stage in its development or product life based on
conditions then prevailing.
1.26    “Conducting Party Compound(s)” shall mean (i) in the case of BMS as the
Conducting Party, the BMS Compound(s) and (ii), in the case of Exelixis as the
Conducting Party, the Exelixis Compound.
1.27    “Confidential Information” shall have the meaning set forth in Section
9.1 of this Agreement.
1.28    “Control” or “Controlled” shall mean, with respect to particular
information or intellectual property, that the applicable Party or any Affiliate
of such Party owns or has a license to such information or intellectual property
and has the ability to grant a right, license or sublicense to the other Party
as provided for herein without violating the terms of any agreement or other
arrangement with any Third Party.
1.29    “Cover” means, with respect to a Patent, that, but for rights granted to
a Person under such Patent, the practice by such Person of an invention
described in such Patent would infringe a claim included in such Patent, or in
the case of a Pat dewent that is a patent application, would infringe a claim in
such patent application if it were to issue as a patent. “Covered” or “Covering”
shall have correlative meanings.
1.30    “CRO” means any Third Party contract research organization used to
conduct a Combined Therapy Trial, including laboratories and Third Parties used
to maintain the safety

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database from a Combined Therapy Trial, but, for clarity, excluding clinical
trial sites and any Third Parties who are individuals.
1.31    “Effective Date” shall have the meaning set forth in the preamble to
this Agreement.
1.32    “Executive Officers” shall mean the [ * ] of Exelixis and the [ * ] of
BMS (or their respective designees).
1.33    “Exelixis” shall have the meaning set forth in the preamble to this
Agreement.
1.34     “Exelixis Compound” shall mean Exelixis’ tyrosine kinase inhibitor
known as Cabozantinib.
1.35    “Exelixis Indemnitees” shall have the meaning set forth in Section 11.1
of this Agreement.
1.36    “Exelixis Independent Patent Rights” shall mean any Patent Rights
Controlled by Exelixis (or its Affiliates) as of the Effective Date or during
the Term through efforts outside of this Agreement that Cover the use (whether
alone or in combination with other agents), manufacture, formulation, or
composition of matter of the Exelixis Compound, but excluding any Exelixis Study
Patent and Exelixis’ interest in any Combined Therapy Patent Right.
1.37    “Exelixis Regulatory Documentation” shall mean any Regulatory
Documentation related to the Exelixis Compound that exists as of the Effective
Date or that is created during the Term through efforts outside this Agreement.
1.38    “Exelixis Study Data” shall have the meaning set forth in Section 8.2 of
this Agreement.
1.39    “Exelixis Study Invention” shall mean any Invention that relates to (a)
the composition of matter of the Exelixis Compound (and not any BMS Compound),
(b) a method of manufacture or formulation of the Exelixis Compound (and not any
BMS Compound) as a Single Agent, or (c) a method of use of the Exelixis Compound
as a monotherapy or as used in combination with agents, antibodies or compounds
that are not one or both of the BMS Compounds.
1.40    “Exelixis Study Patent Rights” shall mean any Patent Rights that Cover
any Exelixis Study Invention (and not a BMS Study Invention or Combined Therapy
Invention) or Exelixis Study Data, excluding Exelixis Independent Patent Rights
and Exelixis Technology. For the avoidance of doubt, any Patent Rights that
cover both (x) an Exelixis Study Invention and (y) any other type of Invention
is included within the Combined Therapy Patent Rights.
1.41    Exelixis Technology” shall mean all Technology Controlled by Exelixis
(or its Affiliates) as of the Effective Date or during the Term through efforts
outside of this Agreement related to the Exelixis Compound or the Combined
Therapy and necessary for the conduct of the Combined Therapy Trials. For
clarity, Exelixis Technology does not include (a) Inventions, (b) Study Data, or
(c) Combined Therapy Trial Regulatory Documentation.

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1.42    “Exelixis Territory” means the United States.
1.43    “FDA” shall mean the United States Food and Drug Administration, or any
successor agency having the same or similar authority.
1.44    “Field” shall mean the treatment of patients with indication(s) to be
studied in a Combined Therapy Trial as set forth in the Protocol(s).
1.45    “FTE” means the equivalent of the work of appropriately qualified
individuals working in support of a Combined Therapy Trial for a total of [ * ]
hours per year of dedicated effort. The billable FTEs shall equal the actual
number of hours worked by such qualified individuals on the Combined Therapy
Trial, divided by [ * ]. FTE efforts shall not include the work of general
corporate or administrative personnel.
1.46    “FTE Rate” means the yearly rate of [ * ] U.S. Dollars ($[ * ]), which
rate shall be increased [ * ] during the Term by [ * ] starting on January 1,
2018.
1.47    “Global Safety Database” shall mean the database containing serious
adverse events, serious adverse drug reactions and pregnancy reports for the
Combined Therapy, and shall be the authoritative data source for regulatory
reporting and responding to regulatory queries.
1.48    “Good Clinical Practices” or “GCP” shall mean, as to the United States
and the European Union, applicable good clinical practices as in effect in the
United States and the European Union, respectively, during the Term and, with
respect to any other jurisdiction, clinical practices equivalent to good
clinical practices as then in effect in the United States or the European Union.
1.49    “Good Laboratory Practices” or “GLP” shall mean, as to the United States
and the European Union, applicable good laboratory practices as in effect in the
United States and the European Union, respectively, during the Term and, with
respect to any other jurisdiction, laboratory practices equivalent to good
laboratory practices as then in effect in the United States or the European
Union.
1.50    “Good Manufacturing Practices” or “GMP” shall mean, as to the United
States and the European Union, applicable good manufacturing practices as in
effect in the United States and the European Union, respectively, during the
Term and, with respect to any other jurisdiction, manufacturing practices
equivalent to good manufacturing practices as then in effect in the United
States or the European Union.
1.51    “IND” shall mean (a) an Investigational New Drug Application as defined
in the United States Food, Drug and Cosmetic Act, as amended, and regulations
promulgated thereunder, or any successor application or procedure required to
initiate clinical testing of a drug in humans in the United States; (b) a
counterpart of such an Investigational New Drug Application that is required in
any other country before beginning clinical testing of a drug in humans in such
country, including, for clarity, a “Clinical Trial Application” in the European
Union; and (c) all supplements and amendments to any of the foregoing.

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1.52    “Initiation” shall mean dosing of the first patient in any Combined
Therapy Trial.
1.53    “Invention” shall mean any invention or Technology, whether or not
patentable, that is made, conceived, generated or first actually reduced to
practice by or on behalf of a Party (or an Affiliate thereof), or by or on
behalf of the Parties (or Affiliates thereof) together (including by a Third
Party in the performance of the Combined Therapy Trial), in the performance of a
Combined Therapy Trial, Statistical Analysis Plan or Bioanalysis Plan to be
conducted under this Agreement, but excluding any Study Data.
1.54    “Ipsen” shall have the meaning set forth in the recitals of this
Agreement.
1.55     “Ipsen-Exelixis Agreements” means that certain Collaboration and
License Agreement between Exelixis and Ipsen dated as February 29, 2016, as
amended from time to time, and agreements between Exelixis and Ipsen and their
Affiliates relating thereto that may be in effect from time to time.
1.56    “Ipsen Territory” means all the countries of the world other than those
in the Exelixis Territory and the Takeda Territory (i.e., all countries other
than the United States and Japan).
1.57     “Manufacture” or “Manufacturing” shall mean manufacturing, processing,
formulating, packaging, labeling, holding (including storage), and quality
control testing of a Single Agent Compound or the Combined Therapy, in each case
so as to be suitable for use in the Combined Therapy Trials under Applicable
Law.
1.58    “Material Safety Issue” means a Party’s good faith belief that there is
an unacceptable risk for harm in humans based upon: (i) pre-clinical safety
data, including data from animal toxicology studies; or (ii) the observation of
serious adverse effects in humans after the Exelixis Compound or the BMS
Compound, either as a Single Agent or in combination with another pharmaceutical
agent (including as the Combined Therapy), has been administered to or taken by
humans, such as during the Combined Therapy Trial.
1.59     “Non-Conducting Party Compound(s)” shall mean (i) in the case of BMS as
the Non-Conducting Party, the BMS Compound(s) and (ii) in the case of Exelixis
as the Non-Conducting Party, the Exelixis Compound.
1.60    “Ono” shall have the meaning set forth in the recitals of this
Agreement.
1.61    “Ono-BMS Agreements” means those certain Collaboration Agreements
between BMS and Ono dated as September 20, 2011 and as of July 23, 2014, as
amended from time to time, and agreements between Ono and BMS and their
Affiliates relating thereto that may be in effect from time to time.
1.62    “Ono Territory” means Japan, South Korea and Taiwan.
1.63    “Party” or “Parties” shall have the meaning set forth in the preamble to
this Agreement.

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1.64    “Patent Rights” shall mean any and all (a) United States or foreign
patents; (b) United States or foreign patent applications, including all
provisional applications, substitutions, continuations, continuations-in-part,
divisions, renewals, and all patents granted thereon; (c) United States or
foreign patents-of-addition, reissues, reexaminations (including without
limitation, ex parte reexaminations, inter partes reviews, inter partes
reexaminations, post grant reviews and supplemental examinations) and extensions
or restorations by existing or future extension or restoration mechanisms,
including supplementary protection certificates, patent term extensions, or the
equivalents thereof; and (d) any other form of government-issued right
substantially similar to any of the foregoing, and “Patent” shall mean any of
the foregoing issued or granted rights.
1.65    “PD-1” shall mean programmed cell death protein 1.

1.66    “PD-L1” shall mean programmed death-ligand 1.

1.67    “Person” shall mean an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated
association, joint venture or other similar entity or organization, including a
government or political subdivision, department or agency of a government.

1.68    “Quarter” shall mean a calendar quarter.

1.69    “Regulatory Authority” shall mean the FDA or any other governmental
authority outside the United States (whether national, federal, provincial
and/or local) that is the counterpart to the FDA, including the European
Medicines Agency for the European Union.

1.70    “Regulatory Documentation” shall mean, with respect to a product
containing a BMS Compound as monotherapy, the BMS Compounds as a combination
therapy or the Exelixis Compound as monotherapy, all submissions to Regulatory
Authorities in connection with the development of such product, including all
INDs and amendments thereto, BLAs, NDAs and amendments thereto, drug master
files, correspondence with regulatory agencies, periodic safety update reports,
adverse event files, complaint files, inspection reports and manufacturing
records, in each case together with all supporting documents (including
documents with respect to clinical data).
1.71    “Right of Cross-Reference” shall mean, with regard to a Party, allowing
the applicable Regulatory Authority in a country to have access to relevant
information (by cross-reference, incorporation by reference or otherwise)
contained in Regulatory Documentation (and any data contained therein) filed
with such Regulatory Authority with respect to a Party’s Compound(s) (and, in
the case of the Non-Conducting Party, the Right to Cross-Reference the Combined
Therapy IND), only to the extent necessary for the conduct of a Combined Therapy
Trial in such country or as otherwise expressly permitted or required under this
Agreement to enable a Party to exercise its rights or perform its obligations
hereunder, and, except as to information contained in

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the Combined Therapy IND relating to the Combined Therapy, without the
disclosure of such information to such Party.
1.72    “Samples” shall mean biological specimens collected from Combined
Therapy Trial study subjects (including [ * ]).
1.73     “Single Agent Compound” or “Compound” shall mean, (a) with respect to
Exelixis, the Exelixis Compound, and (b) with respect to BMS, each of the BMS
Compounds, in each case as monotherapy.
1.74    “Statistical Analysis Plan” shall mean the set of analyses (including
statistical analysis) of the Study Data for each Combined Therapy Trial
conducted hereunder prepared by the Conducting Party (in consultation with the
Non-Conducting Party) and approved by the JDC and shall include safety analyses
for the Combined Therapy in each Combined Therapy Trial. The Statistical
Analysis Plan document for a Combined Therapy Trial must be approved by the JDC
before database lock.
1.75    “Takeda” shall have the meaning set forth in the recitals of this
Agreement.
1.76     “Takeda-Exelixis Agreements” means that certain Collaboration and
License Agreement between Exelixis and Takeda dated as January 30, 2017, as
amended from time to time, and agreements between Exelixis and Takeda and their
Affiliates relating thereto that may be in effect from time to time.
1.77    “Takeda Territory” means Japan.
1.78    “Technology” shall mean information, inventions, discoveries, trade
secrets, knowledge, technology, methods, processes, practices, formulae,
instructions, skills, techniques, procedures, experiences, ideas, technical
assistance, designs, drawings, assembly procedures, computer programs,
specifications, data and results not generally known to the public (including
biological, chemical, pharmacological, toxicological, pharmaceutical, physical
and analytical, pre-clinical, clinical, safety, manufacturing and quality
control data and know-how, including study designs and protocols), in all cases,
whether or not patentable, in written, electronic or any other form now known or
hereafter developed, materials, data and results, including Regulatory
Documentation.
1.79    “Third Party” shall mean any Person or entity other than Exelixis and
BMS and their respective Affiliates.
1.80    “Third Party License Payments” shall mean any payments (e.g., upfront
payments, milestones, royalties) due to any Third Party under license agreements
or other written agreements granting rights to intellectual property owned or
controlled by such Third Party to the extent that such rights are necessary for
(i) the making, using or importing of a Party’s Compound(s) for the conduct of
any Combined Therapy Trial, or (ii) the conduct of any Combined Therapy Trial.

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1.81    “United States” or “U.S.” shall mean the United States of America, and
its territories, districts and possessions.
Additional Definitions. In addition to those terms defined above, definitions
for each of the following terms are found in the body of this Agreement as
indicated below:
Defined Term
Section
Alliance Manager
2.6
Breaching Party
12.2(a)
CDA
9.1
Tyrosine Kinase Inhibitor Trial
5.4(d)
Co-Chair
2.3(a)
Cure Period
12.2(a)
Dispute
13.3(a)
Exclusive Discussion Period
5.4(d)
GAAP
4.1(a)
ICF
2.5(a)
Indemnify
11.1
Infringe or Infringement
6.3(a)
Initial Trials
2.1(a)
IRBs
9.3(d)
JCS-WG or Joint Clinical Study Working Group
2.4(a)
JDC or Joint Development Committee
2.3
JDC Dispute
2.7
Conducting Party
2.1(b)
License Agreement
13.1
Licensee
13.10(b)
Losses
11.1
Non-Breaching Party
12.2(a)
Non-Conducting Party
5.1(b)
Non-Prosecuting Party
6.1(c)
Officials
10.9
Operational Matters
2.5(a)
Packaging and Labeling Cost
4.2(b)
Payment
10.9
Pharmacovigilance Agreement
2.2
POTV
9.7(a)
Prosecuting Party
6.1(c)
Protocol
2.1(a)
Publication Dispute
9.6(b)

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Quality Agreement
4.3
Quarterly Report
7.2(a)
Results
9.6(b)
Section 4.1(b) Costs
4.1(b)
Section 4.2(b) Costs
4.2(b)
Shared Costs
7.1
Site/CRO List
2.5(c)
Study Data
8.1
Sunshine Laws
9.7(c)
Supply Agreement
4.4
Term
12.1
Third Party Claim
11.1
True-up Payment
7.2(a)

 
ARTICLE 2
COLLABORATION SCOPE; GOVERNANCE
2.1    Scope of Collaboration; Governance of Agreement.
(a)    The Parties intend, pursuant to this Agreement, to collaborate to conduct
(i) the clinical trials identified in Exhibit A (referred to as the “Initial
Trials”) and (ii) such other clinical trials evaluating a Combined Therapy of
the BMS Compound(s) with the Exelixis Compound as the Parties may agree to
conduct pursuant to the terms of this Agreement (any such trial in (i) or (ii),
a “Combined Therapy Trial”). A clinical study protocol (including a clinical
protocol synopsis) for each Combined Therapy Trial will be approved by the JDC
(each, a “Protocol”). The Parties will also use good faith efforts to consult
with each other and to finalize the Protocol for the Initial Trial for Renal
Cell Carcinoma based on the draft clinical protocol synopsis set forth in
Exhibit B and the Protocol for the Initial Trial for Hepatocellular Carcinoma
based on the draft clinical protocol synopsis set forth in Exhibit C) as
promptly as practicable after the Effective Date. Each Combined Therapy Trial
shall be conducted in accordance with its Protocol. The Protocol for each
Combined Therapy Trial shall be drafted by the Conducting Party (in consultation
with the Non-Conducting Party), and shall be subject to review and approval of
the JDC before such Combined Therapy Trial can be Initiated. Protocol
amendment(s) shall be subject to review and approval of the JDC, although the
JDC may discuss and agree in writing upon circumstances where it may be feasible
for the Conducting Party to make specific Protocol amendments without the need
for JDC approval or mutual written agreement.
(b)    The Party primarily responsible for the conduct of a Combined Therapy
Trial (such Party, with respect to such Combined Therapy Trial, the “Conducting
Party”) for each of the Initial Trials is identified in Exhibit A. The Parties
shall determine, through the JDC, which Party shall be the Conducting Party for
any other Combined Therapy Trial. Subject to the oversight of the JDC, as
between the Parties, the Conducting Party shall have decision-making authority
with

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respect to all non-material operational issues in the conduct of the Combined
Therapy Trial, pursuant to Section 5.1(a), and shall be the regulatory lead and
the sponsor of record with respect to a Combined Therapy Trial. Each Combined
Therapy Trial shall be conducted under a combination IND unless a Regulatory
Authority requires otherwise, for which the Conducting Party will be the sponsor
of record (the “Combined Therapy IND”). BMS shall have a beneficial one-half
interest in such Combined Therapy IND and Exelixis shall have a beneficial
one-half interest in such Combined Therapy IND; provided, however, that: (i) in
no event will a Party be required to obtain the consent of the other Party to
transfer or encumber its interest in the Combined Therapy IND; provided, that
the transferee or encumbrance holder agrees to abide by the terms and conditions
of this Agreement, and provided, that any transfer occurs only in connection
with, and to the same transferee of, a transfer of all of a Party’s rights in
its Single Agent Compound, (ii) the Conducting Party shall be the sole holder of
all legal interests in the Combined Therapy IND, and no Party shall have any
obligation to share with the other Party any consideration received in
connection with the sale, license or use of the Combined Therapy IND where
permitted by this Agreement, and (iii) no Party shall be permitted to grant any
Third Party any Right of Cross-Reference with respect to any portion of the
Combined Therapy IND relating to the other Party’s Single Agent Compound(s) for
use as monotherapy or for use in combination with any other molecules (other
than, in the case of BMS, for use with the BMS Compound(s) (alone or in
combination with other BMS-controlled molecules), and, in the case of Exelixis,
for use with the Exelixis Compound (alone or in combination with other
Exelixis-controlled molecules), in each case as permitted by this Agreement. For
clarity, each Party shall have a Right of Cross-Reference to all Combined
Therapy INDs, whether such Party is the Conducting Party or the Non-Conducting
Party, on its own behalf. Each Party shall provide to the other Party a Right of
Cross-Reference to its existing respective IND for its respective Single Agent
Compound(s) as necessary to allow a Combined Therapy Trial to be conducted under
the Combined Therapy IND. For the avoidance of doubt, each Party shall be
responsible for (i) drafting and updating as necessary the investigator’s
brochure for its respective Single Agent Compound(s), and (ii) filing all
necessary Regulatory Documentation to the existing IND for its respective Single
Agent Compound(s), including, but not limited to, the submission to such
existing IND of serious adverse event and adverse drug reaction cases emerging
from any Combined Therapy Trial, as required by a Regulatory Authority and/or
Applicable Law.
(c)    Promptly after the Effective Date, if not previously provided pursuant to
the CDA and continuing until finalization of the Protocol for the applicable
Initial Trial, the Conducting Party shall provide the Non-Conducting Party with
the following relating to the Conducting Party Compound(s): (i) the latest
investigator’s brochure, (ii) new and/or changing safety signals and safety
issues pertinent to the Initial Trials, and (iii) new and/or changing toxicology
and efficacy signals and/or issues pertinent to the Initial Trials. The
Conducting Party shall also provide such other safety data on the Conducting
Party Compound(s) as set forth in the Pharmacovigilance Agreement. The
Non-Conducting Party shall use any such data provided pursuant to this Section
2.1(c)(1) or pursuant to the Pharmacovigilance Agreement solely to evaluate the
safety and efficacy of (1) the Conducting Party Compound(s) for use in Combined
Therapy Trials and (2) the Combined Therapy. All such information and
disclosures, to the extent pertaining to the Conducting Party

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Compound(s) as monotherapy (or used with agents other than the Non-Conducting
Party Compound(s)), are Confidential Information of the Conducting Party.
(d)    The Conducting Party shall provide the Non-Conducting Party with the
following relating to the Combined Therapy: (i) safety analyses for each
Combined Therapy Trial where required by and in accordance with the applicable
Protocol, and/or Statistical Analysis Plan, (ii) new and/or changing safety
signals and safety issues pertinent to the Combined Therapy Trials and such
other safety data for each Combined Therapy as set forth in the
Pharmacovigilance Agreement (as defined in Section 2.2), and (iii) new and/or
changing toxicology and efficacy signals and/or issues pertinent to the Combined
Therapy Trials. The Conducting Party shall also provide the Non-Conducting Party
with the Study Data and the final Clinical Study Reports (CSRs) for all Protocol
arms relating to this Agreement. Each final CSR shall comply with the
requirements of the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) and shall be approved by
the JDC. Each Party shall use any such data provided pursuant to this Section
2.1(d) solely: (A) to evaluate the safety and efficacy of the Combined Therapy
in Combined Therapy Trials, (B) to meet any regulatory requirements pertaining
to its Compound(s) and to the conduct of the Combined Therapy Trials, and (C) as
permitted elsewhere in this Agreement. All such information and disclosures: (x)
to the extent pertaining to a Combined Therapy, are Confidential Information of
all of the Parties, (y) to the extent pertaining to the Exelixis Compound as
monotherapy (or used with agents other than the BMS Compound(s)), are
Confidential Information of Exelixis and (z) to the extent pertaining to the BMS
Compound(s) as monotherapy (or used with agents other than the Exelixis
Compounds), are Confidential Information of BMS.
(e)    The Conducting Party shall provide the Non-Conducting Party with the
following relating to the Non-Conducting Party Compound(s): (i) safety analyses
for the Non-Conducting Party Compound(s) as monotherapy from each Combined
Therapy Trial if required by and in accordance with the applicable Protocol,
and/or Statistical Analysis Plan, and (ii) such other safety data for the
Non-Conducting Party Compound(s) as set forth in the Pharmacovigilance
Agreement. The Non-Conducting Party may use such information for any purpose.
All such information and disclosures to the extent pertaining to the BMS
Compound(s) as monotherapy (or used with agents other than the Exelixis
Compound), shall be Confidential Information of BMS and all such information and
disclosures to the extent pertaining to the Exelixis Compound as monotherapy (or
used with agents other than the BMS Compound(s)), shall be Confidential
Information of Exelixis.
(f)    Promptly after the Effective Date, if not previously provided pursuant to
the CDA and continuing until finalization of the Protocol for the applicable
Initial Trial, the Non-Conducting Party shall provide the Conducting Party with
the following relating to the Non-Conducting Party Compound(s): (i) the latest
investigator’s brochure, (ii) any new and/or changing safety signals and safety
issues pertinent to the Initial Trial, and (iii) new and/or changing toxicology
and efficacy signals and/or issues pertinent to the Initial Trial. The
Non-Conducting Party shall also provide such other safety data on the
Non-Conducting Party Compound(s) as set forth in the Pharmacovigilance
Agreement. The Conducting Party shall use any such data provided pursuant

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to this Section 2.1(f) or pursuant to the Pharmacovigilance Agreement solely (A)
to evaluate the safety and efficacy of (1) the Non-Conducting Party Compound(s)
for use in Combined Therapy Trials and (2) the Combined Therapy and (B) to meet
any regulatory requirements pertaining to the conduct of the Combined Therapy
Trials. All such information and disclosures are Confidential Information of the
Non-Conducting Party.
(g)    Any amendment to this Agreement, a Bioanalysis Plan, a Statistical
Analysis Plan, the Pharmacovigilance Agreement, the CRO Agreement (to the extent
provided in Section 2.4(o)) or Quality Agreement shall require the written
mutual agreement of the Parties and shall be executed in the form of a written
amendment in accordance with Section 13.7.
(h)    If further studies, including but not limited to toxicity studies, are
required or suggested by a Regulatory Authority as a prerequisite for conducting
any of the Combined Therapy Trials, then the Parties agree to hold good faith
discussions in a timely manner to agree upon a protocol for such studies, each
of which will be considered a Combined Therapy Trial and conducted on
substantially the same terms as set forth herein; provided that, if the Parties
are unable to agree upon a protocol for such study or if the conduct of such
study shall cause a delay deemed unsatisfactory by a Party, then any disputed
matters precluding agreement shall be referred to the Executive Officers (or
their respective designees) for resolution. If the Executive Officers are unable
to reach resolution within [ * ] after such referral to them (and do not
mutually agree to an extension of time to arrive at such resolution), then this
Agreement shall automatically terminate following the conclusion of any
then-active Combined Therapy Trial (unless and until the Protocol for such
required/suggested study(ies) is finalized by mutual agreement prior to the
completion of such Combined Therapy Trial) and the provisions of Section 12.5
shall apply to any such termination.
2.2    Safety Data Exchange. The Parties shall use diligent efforts to define
and finalize the processes the Parties shall employ to protect patients and
promote their well-being in connection with the use of the Combined Therapy.
Subject to the terms of this Agreement, within [ * ] or [ * ] after the full
execution of this Agreement, or as soon as practicable subsequent to the full
execution date, as agreed to by the Parties and prior to dosing the first study
patient in a Combined Therapy Trial, Exelixis and BMS (under the guidance of
their Pharmacovigilance Departments, or equivalent thereof) shall execute a
written pharmacovigilance agreement (“Pharmacovigilance Agreement”) to ensure
the exchange of relevant safety data within appropriate timeframes and in
appropriate format to enable the Parties to fulfill local and international
regulatory reporting obligations. Such Pharmacovigilance Agreement shall (a)
provide that the Conducting Party shall hold and be responsible for the
maintenance of the Global Safety Database for the Combined Therapy and safety
reporting for the Combined Therapy, and shall lead all pharmacovigilance
activities for the Combined Therapy, and (b) include guidelines and procedures
acceptable to the Parties for the receipt, investigation, recordation,
communication, and exchange (as between the Parties) of Adverse Event reports,
pregnancy reports, and any other information concerning the safety of the
Combined Therapy arising from or related to the use of the BMS Compound(s) and
Exelixis Compound in the Combined Therapy Trial consistent with Applicable Law.
Furthermore, such agreed procedures shall be consistent with relevant
International Council for Harmonization (ICH)

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guidelines, except where said guidelines may conflict with existing local
regulatory safety reporting requirements, in which case local reporting
requirements shall prevail. Until such guidelines and procedures are set forth
in the Pharmacovigilance Agreement, the Party responsible for pharmacovigilance
prior to execution of this Agreement shall have sole pharmacovigilance
responsibility for its Compound(s) subject to all Applicable Law. In the event
that this Agreement is terminated, the Parties agree to implement the necessary
procedures and practices to ensure that any outstanding pharmacovigilance
reporting obligations are fulfilled. To the extent any provision set forth in
the Pharmacovigilance Agreement conflicts with any provision in this Agreement,
the provision set forth in the Pharmacovigilance Agreement shall control as
related to the exchange and reporting of safety information associated with use
of the products in a Combined Therapy Trial as well as product safety
surveillance.
2.3    Joint Development Committee. Promptly after the Effective Date, the
Parties shall form a Joint Development Committee (the “JDC”).
(a)    Composition: The JDC shall consist of [ * ] representatives, with [ * ]
representatives from BMS, on the one hand, and [ * ] representatives from
Exelixis, on the other hand, plus an Alliance Manager from each Party as
non-voting members; provided, that the JDC may agree to increase or decrease the
number by mutual agreement. Each Party shall be responsible for determining the
qualifications and substitutions of its JDC members but shall be composed of
cross functional and highly experienced representatives of appropriate seniority
from Exelixis and BMS. The JDC shall be co-chaired by two (2) chairpersons, with
one chairperson designated by BMS and the other chairperson to be designated by
Exelixis (each, a “Co-Chair”).
(b)    Meetings: The JDC shall meet at least [ * ] per year, or at such other
frequency as the JDC agrees (and it may appoint subteams to meet more
frequently), provided that either BMS or Exelixis through its Co-Chair may
request a meeting of the JDC at any time upon [ * ] notice to the other Party,
with the understanding that the other Party will use reasonable efforts to
comply with such request but such other Party will not be in breach of this
Agreement in the event that it is unable to comply with such request but is
using reasonable efforts to conduct a JDC meeting as promptly as practicable.
Upon request by either Party, such meetings will be held by audio or video
teleconference; provided that face-to-face meetings shall occur at least [ * ].
There must be a minimum of [ * ] representatives from each of BMS, on the one
hand, and Exelixis, on the other hand, at any meeting of the JDC. No fewer than
[ * ] prior to each meeting, and in any event as soon as reasonably practicable,
each of BMS and Exelixis shall use good faith efforts to disclose to the other
any proposed agenda items together with appropriate supporting information. The
Alliance Managers shall alternate responsibility for preparing and circulating
definitive minutes of each meeting of the JDC. Such minutes shall provide a
description, in reasonable detail, of the discussions at the meeting, a list of
material actions and decisions made by the JDC, a list of action items made by
the JDC and a list of material issues not resolved by the JDC. The Alliance
Manager who drafts the minutes shall provide the Co-Chairs and the other
Alliance Manager with the initial draft meeting minutes, who shall return the
draft with any proposed changes, and this process shall be repeated until a
final version of the meeting minutes is agreed upon and signed (or acknowledged

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as final via email) by the two Co-Chairs. The Parties shall reasonably cooperate
to complete and agree upon a final version of meeting minutes within [ * ] from
the date of the relevant meeting. The final version of the meeting minutes shall
be signed (or acknowledged as final via email) by the two Co-Chairs, and each
Party shall be provided with a copy of the final meeting minutes for its
safekeeping. A reasonable number of additional representatives of a Party may
attend meetings of the JDC in advisory capacity with the prior written consent
of the other Party. All representatives to the JDC or attending JDC meetings
shall be subject to confidentiality and nonuse restrictions at least as
restrictive as those set forth herein.
(c)    Responsibilities of the Joint Development Committee: The JDC shall be
responsible for:
(i)    The constitution of the Joint Clinical Study Working Group (as defined
below) and the establishment of such other subcommittees and working groups as
the JDC decides is necessary.
(ii)    Overseeing the activities of, and providing guidance and directives to,
the Joint Clinical Study Working Group and resolving any disputes arising at the
Joint Clinical Study Working Group level.
(iii)    Reviewing the regulatory strategy regarding each Combined Therapy
Trial.
(iv)    Resolving any disputes between the Parties relating to execution of the
Combined Therapy Trials.
(v)    Consulting and reviewing in relation to the overall management of the
Combined Therapy Trials and on all significant matters relating to the Combined
Therapy Trials.
(vi)    Monitoring the nature, progress and results of the Combined Therapy
Trials;
(vii)    Selecting and approving independent data monitoring committees and
independent radiologic reviews;
(viii)    Approving the Protocols (including any Statistical Analysis Plan) and
any proposed amendments thereto for the Combined Therapy Trials together with a
budget for each Combined Therapy Trial (including the Shared Costs) and any
material amendments thereto;
(ix)    Approving the Bioanalysis Plan and any amendments thereto;
(x)    Monitoring the key milestones of each Combined Therapy Trial proposed by
the Joint Clinical Study Working Group;

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(xi)    Approving the final clinical trial report (and/or final statistical
analysis in accordance with the Statistical Analysis Plan) from each Combined
Therapy Trial;
(xii)    Approving the material communication strategies with any Regulatory
Authority regarding the conduct of the Combined Therapy Trials, and to the
extent reasonably possible, approving timing for scheduled meetings with any
Regulatory Authority;
(xiii)    Approving any Combined Therapy IND to be submitted to a Regulatory
Authority and any material amendments thereto;
(xiv)    Discussing additional Combined Therapy Trials of the BMS Compound(s)
with the Exelixis Compound, provided that no Party shall be obligated to
collaborate with the other Party or agree on terms with the other with respect
to any additional clinical trials pursuant to this Section 2.3(c)(xii); and
(xv)    Discussing whether any pre-clinical studies are needed to explore or
support any clinical trial for the Combined Therapy, especially for clinical
trials for indications other than those for the Initial Trials.
In the event the JDC determines that any pre-clinical study is needed to explore
or support any clinical trial for the Combined Therapy, any such pre-clinical
study will only be conducted if the Parties enter into a separate agreement for
the conduct of such pre-clinical study.
(d)    Joint Development Committee Authority. The JDC shall take action by
unanimous consent, with each of BMS, on the one hand, and Exelixis, on the other
hand, having a single vote, irrespective of the number of its representatives
actually in attendance at a meeting. In the absence of a formal meeting, the [ *
]. The JDC shall have the right to make only those determinations expressly
enumerated as decisions of the JDC in this Agreement; provided that such
determinations are documented in the written minutes signed (or acknowledged as
final via email) by the JDC Co-Chairs. Notwithstanding anything to the contrary
in this Agreement, the JDC will have no power (i) to amend this Agreement, the
Supply Agreement, the Pharmacovigilance Agreement or the Quality Agreement, or
(ii) to modify any Party’s obligations with regard to the conduct of the
Combined Therapy Trials without such Party’s prior written consent; in each
case, except by a writing signed by all Parties.
2.4    Joint Clinical Study Working Group:
(a)    General. A joint clinical study working group (“Joint Clinical Study
Working Group” or “JCS-WG”) shall be appointed by the JDC. The JCS-WG shall be
composed of highly experienced representatives of Exelixis and BMS, and may
include a reasonable number (as agreed to by BMS and Exelixis) of
representatives of Ipsen; provided, however before attending or participating in
any meeting or telephone conference of the JCS-WG, each such representative (i)
must be identified in advance to the Alliance Managers, (ii) must have executed
a form of

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confidentiality and invention assignment agreement mutually acceptable to the
Parties that will cover the proceedings of the JCS-WG and that will have been
reviewed and approved by Ipsen, and (iii) must be highly experienced with
respect to the matters for which the JCS-WG has responsibility. The JCS-WG will
be co-chaired by one Exelixis representative and one BMS representative. The
JCS-WG will meet at least [ * ] (or at a frequency reasonably considered
necessary at the request of either Party) to provide an update on progress of
the Combined Therapy Trials to the JDC. Except for decisions expressly reserved
to the JDC, the JCS-WG shall be responsible for the coordination and execution
of all joint operational matters (i.e., clinical drug supply, response to
regulatory agency questions, data exchange, pharmacovigilance, etc.). The
Conducting Party shall provide such update on progress of the Combined Therapy
Trials in writing to the Non-Conducting Party members of the JCS-WG on a [ * ]
basis, which update shall contain information about overall progress,
recruitment status, interim analysis (if results available), final analysis and
other information relevant to the conduct of the Combined Therapy Trials.
(b)    Specific Responsibilities of the JCS-WG. Each Party shall keep the JCS-WG
informed about activities performed by that Party hereunder. The JCS-WG (or in
the absence of a formal meeting, the Co-Chairs of the JCS-WG) shall be
specifically responsible, without limitation, for the following:
(i)    overseeing the activities of the Parties with respect to the Combined
Therapy Trials, and providing a forum for the Parties to discuss, monitor and
coordinate all activities and communications regarding the Combined Therapy
Trials;
(ii)    reviewing the progress of each Combined Therapy Trial, (ii) reviewing
and approving the proposed plan for medical monitoring and exchange information
on planned site audits, and (iii) reviewing the results of such medical
monitoring and site audits and agreeing on any actions in response to same;
(iii)    preparing, reviewing and proposing to the JDC for its approval (i) the
applicable Protocol and the Statistical Analysis Plan, and any proposed
amendment thereto and (ii) any Bioanalysis Plan not set forth in the Protocol,
and any amendments thereto;
(iv)    preparing, reviewing and proposing to the JDC for its approval the
communication strategies with any Regulatory Authority regarding the conduct of
the Combined Therapy Trials and, to the extent they are materially inconsistent
with the applicable Protocol(s) or previously-approved strategies (or involve
patient safety or relate to the BMS Compound(s) or Exelixis Compound), reviewing
and approving such proposed communications and communication strategies;
(v)    preparing, reviewing and endorsing for approval by the JDC any Combined
Therapy IND to be submitted to a Regulatory Authority, as well as reviewing
material submissions to any such IND in accordance with Article 5 and, to the
extent they are materially inconsistent with the applicable Protocol(s) (or
involve patient safety or relate to the BMS Compound or the Exelixis Compound),
reviewing and approving such submissions;

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(vi)    preparing, reviewing and approving any material Combined Therapy Trial
Regulatory Documentation, or portions thereof, that relate to the Combined
Therapy, in accordance with Article 5, and, to the extent they are materially
inconsistent with the applicable Protocol(s), reviewing and approving such
Combined Therapy Trial Regulatory Documentation, or portions thereof;
(vii)    preparing, reviewing and approving in advance, any additional analyses
of, or that include, the Combined Therapy Study Data proposed by either Party
that are not included in the Statistical Analysis Plan; provided, that, for
clarity, such review and approval shall not apply to analyses by a Party of the
monotherapy data for its own Compound(s) from a Combined Therapy Trial.
(viii)    preparing, reviewing and approving use of any Samples in accordance
with Section 8.5 that are not described in the Protocol and ICF for a given
Initial Trial, so long as the JDC/JCS-WG remains in force and effect (and if not
in force and effect, by mutual written agreement of the Parties);
(ix)    reviewing and approving the template ICF form, the template case report
form and template clinical site study agreement (or minimum language to be
included therein) (all such templates will be based on the applicable Conducting
Party template) to be used in a given Combined Therapy Trial. The Conducting
Party may authorize changes to such template or minimum wording without review
and approval of the JCS-WG, so long as (1) such changes are not materially
substantive changes relative to, and the form/agreement remains otherwise
generally consistent with, the original wording, (2) in the case of Exelixis as
the Conducting Party, such changes do not relate to or adversely affect the BMS
Technology or BMS Independent Patent Rights (or the enforcement or defense
thereof), the Combined Therapy, or the BMS Compound(s) as monotherapy, (3) in
the case of BMS as the Conducting Party, such changes do not relate to or
adversely affect the Exelixis Technology or Exelixis Independent Patent Rights
(or the enforcement or defense thereof), the Combined Therapy, or the Exelixis
Compound as monotherapy, (4) such changes do not impose a new obligation,
whether direct, indirect, or contingent, upon the Non-Conducting Party, (5) any
changes to the ICF template do not relate to use of Samples or the information
to be disclosed regarding the Non-Conducting Party Compound(s), (6) such changes
do not confer a benefit upon the Conducting Party that is not also conferred
upon the Non-Conducting Party and (7) such changes do not conflict with this
Agreement;
(x)    proposing, reviewing and approving the countries in which each Combined
Therapy Trial will be conducted in accordance with Section 2.5(c), which shall
be limited to those countries in which both the BMS Compound(s) and the Exelixis
Compound that are the subject of such Combined Therapy Trial are being
commercialized and those countries in which it is intended for both the BMS
Compound(s) and the Exelixis Compound that are the subject of such Combined
Therapy Trial to be commercialized when one or more of such Compounds is not
being commercialized in those countries (such countries, collectively the
“Available Countries”);

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(xi)    preparing, reviewing and approving the final clinical trial report
(and/or final statistical analysis in accordance with the Statistical Analysis
Plan) from each Combined Therapy Trial, prior to provision to the JDC for final
approval in accordance with Section 2.3(c)(xi) above;
(xii)    discussing any other topics or issues relating to the Combined Therapy
Trials that either Party requests that cannot be resolved at the working team
level.
(xiii)    reviewing each Party’s drug supply forecasts for each Combined Therapy
Trial;
(xiv)    approving any immunogenicity analysis for each Combined Therapy Trial,
including the protocol and the entity to do the analysis, to the extent not part
of the Protocol for a Combined Therapy Trial;
(xv)    reviewing and approving any provisions deemed necessary to be included
in the CRO agreement to ensure consistency with this Agreement and in particular
with Section 5.2(b) hereof;
(xvi)    agreeing on the selection of study sites pursuant to Section 2.5(c),
and agreeing on any material communications to study sites or IRBs relating to
patient safety or early termination/cessation of the Combined Therapy Trial; and
(xvii)    appointing, if needed, working teams to conduct work within the
charter of the JCS-WG and to report to the JCS-WG, and resolving any disputes
arising within the working teams.
2.5    Conducting Party Operational Authority Generally.
(a)    The Conducting Party for a Combined Therapy Trial shall, subject to the
oversight and determinations of the JDC and JCS-WG as provided in Sections 2.3
and 2.4, the terms of the applicable Protocol, the decisions and guidance of
applicable Committee or working group, and applicable terms and conditions of
this Agreement, the Quality Agreement, the Pharmacovigilance and the Supply
Agreement: (i) manage and be primarily responsible for the conduct of such
Combined Therapy Trial; (ii) be the Sponsor and regulatory lead with respect to
such Combined Therapy Trial; and (iii) as between the Parties, be the lead with
respect to (1) the selection and management of clinical study sites (including
the negotiation and execution of clinical site study agreements and related
budgets, timelines and contingency planning), (2) conducting clinical study
start-up activities, communicating with and obtaining approval from
institutional review boards and/or ethics committees, as applicable, and
drafting the template informed consent form (“ICF”) or other relevant documents
for such Combined Therapy Trial (for review and, if applicable, approval as
provided in this Agreement), (3) subject recruitment and retention activities,
(4) ongoing site monitoring and quality assurance audits, (5) subject to the
terms of the Pharmacovigilance Agreement, management of safety reporting by
contract research organizations and clinical study sites, (6) ongoing medical
monitoring, (7) management, monitoring and audits

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of CROs in connection with each CRO (if any) involved in the conduct of such
Combined Therapy Trial, (8) inquiries from clinical study subjects, (9)
packaging, labeling and distributing the Combined Therapy for use in such
Combined Therapy Trial, and (10) manage health authority inspections at clinical
trial sites ((1)-(10), collectively, the “Operational Matters”). The Conducting
Party shall use Commercially Reasonable Efforts to perform such Operational
Matters. The JDC shall set up a mechanism for the Non-Conducting Party to be
informed and updated on a timely periodic basis regarding Operational Matters,
so that if the Non-Conducting Party has any significant concerns or material
disagreements regarding same, the matter can be escalated to the JDC for review.
Notwithstanding anything to the contrary in this Agreement, in the event that
the Conducting Party receives a telephonic communication from a Regulatory
Authority requesting an immediate response that the Conducting Party reasonably
determines must be immediately given to protect patient safety or to prevent
undue and significant disruption in the conduct of a Combined Therapy Trial, the
Conducting Party will be entitled to provide such response as it deems advisable
(and that is otherwise consistent with the terms of this Agreement); provided,
that it immediately notifies the Non-Conducting Party Co-Chair (or other
Non-Conducting Party member of the JDC if that person is not available) of same
and subsequently either (i) obtains the written consent of the Non-Conducting
Party Co-Chair to the action taken or (ii) if the Non-Conducting Party does not
provide its consent, notifies the Regulatory Authority that the response is
being changed; provided, further, that in no event shall the Conducting Party
make any response relating to the Non-Conducting Party Compound(s) as
monotherapy without the Non-Conducting Party’s prior written consent.
(b)    If the conduct of any Combined Therapy Trial requires a Third Party
License Payment, then the Party required to make such Payment shall be
responsible for same.
(c)    Each Combined Therapy Trial may only be conducted in countries outside
the Ono Territory that are Available Countries. The Conducting Party, after
discussion with the Non-Conducting Party, will create and provide the JDC with a
proposed list of potential clinical trial site(s), countries, CROs and
investigators that may be used to conduct each Combined Therapy Trial, with the
final list to be subject to JDC (or Co-Chairs) approval (such approval will be
completed within [ * ] after receipt of the list and shall not be unreasonably
withheld) (such JDC-approved list being the “Site/CRO List”). The proposed
Site/CRO List will be provided to the JCS-WG prior to the Conducting Party
initiating site selection negotiations or visits (for sites/investigators) or
CRO negotiations (for CROs). The Conducting Party shall have the authority to
select the final clinical trial sites, CROs and investigators from the approved
Site/CRO List. In the event that additional sites need to be added after the
initial list is approved, a new CRO/Study Site List will be created that
includes the new sites and such list will be provided to the JCS-WG for its
approval (or by its Co-Chairs) per this Section 2.5(c).
2.6    Alliance Managers. Each of BMS, on the one hand, and Exelixis, on the
other hand, will appoint one representative to act as its Alliance Manager
(each, an “Alliance Manager”). The role of the Alliance Manager is to act as a
primary point of contact between the Parties to assure a successful relationship
between the Parties. Each Alliance Manager shall be permitted to attend meetings
of the JDC and its subcommittees and working groups as appropriate as non-voting

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participants. An Alliance Manager may bring any matter concerning a Party's
performance under this Agreement to the attention of the JDC if the Alliance
Manager reasonably believes that such attention is warranted. BMS may replace
its Alliance Manager with an alternative representative at any time with prior
written notice to Exelixis, and Exelixis may replace their Alliance Manager with
an alternative representative at any time with prior written notice to BMS. Any
Alliance Manager may designate a substitute to temporarily perform the functions
of such Alliance Manager upon written notice to the other Alliance Manager. Each
Alliance Manager will be charged with creating and maintaining a collaborative
work environment within the JDC. Each Alliance Manager also will:
(a)    provide a point of communication both internally within the Parties’
organizations and between the Parties regarding the Combined Therapy Trials;
(b)    assist in coordinating any collaborative efforts under this Agreement, if
any, and any external communications;
(c)    take responsibility for ensuring that JDC and JCS-WG activities, such as
the conduct of required JDC meetings, occur as set forth in this Agreement and
that relevant action items, if any, resulting from such meetings are
appropriately carried out or otherwise addressed; and
(d)    be the point of first referral in all matters of contract interpretations
and dispute resolution in accordance with Section 13.3.
2.7    Dispute Resolution. The representatives of the JDC shall attempt in good
faith to reach consensus on all matters properly brought before the JDC. Except
as otherwise provided in this Agreement, if, after a good faith, reasonable and
open discussion among the members of the JDC, the JDC is unable to agree on a
matter that has been properly before it for a period of [ * ] and that calls for
a decision, any Party may refer the dispute (a “JDC Dispute”) to the Executive
Officers for resolution. If the Executive Officers are unable to reach a
resolution within [ * ] of such referral, then the JDC Dispute will be referred
to the [ * ] of Exelixis and the [ * ] of BMS or their respective designees for
attempted resolution by good faith negotiations within [ * ] after such referral
is made. If they are unable to reach a resolution within [ * ] of such referral,
then (a) if such JDC Dispute relates to an amendment requiring mutual agreement
proposed by either Party to the agreed upon Protocol or protocol synopsis
(including any immunogenicity analysis), CRO Agreement, Bioanalysis Plan or
Statistical Analysis Plan, there shall be no decision on the matter and the then
existing terms of the applicable Protocol, protocol synopsis, CRO Agreement,
Bioanalysis Plan or Statistical Analysis Plan shall govern, and (b) for all
other JDC Disputes, this Agreement will be terminated, upon written notice from
either BMS to Exelixis or from Exelixis to BMS, as of the later of (1) the
expiration of such [ * ] period for resolution by the [ * ] of Exelixis and the
[ * ] of BMS or their respective designees or (2) the conclusion of any
then-active Combined Therapy Trial (in each of (1) or (2) unless and until such
JDC Dispute is resolved by mutual agreement prior to the effective date of such
termination); provided, that any such termination notice must be

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provided prior to the applicable termination date in (1) or (2). The provisions
of Section 12.5 shall apply to any such termination. Disputes with respect to
matters properly before the JDC will not be subject to the dispute resolution
procedures set forth in Section 13.3.
2.8    Conduct. Each Party shall use Commercially Reasonable Efforts to perform
and fulfill its respective activities under this Agreement, and shall do so in
accordance with Applicable Law, including GCP, GLP and GMP.

ARTICLE 3
LICENSE GRANTS
3.1    Grant by BMS.
(a)    Subject to the terms of this Agreement, BMS hereby grants, and shall
cause its Affiliates to grant, to Exelixis a non-exclusive, worldwide (other
than within the Ono Territory), non-transferable, royalty-free license (with the
right to sublicense solely pursuant to the terms of and subject to the
limitations of Section 3.3) under the BMS Independent Patent Rights, BMS
Technology, and BMS Regulatory Documentation to use the BMS Compound(s), solely
to the extent necessary to discharge Exelixis’ obligations under this Agreement
with respect to the conduct of the Combined Therapy Trials.
(b)    To the extent that a CRO, contractor or Combined Therapy Trial study site
assigns or licenses to BMS any title, rights or interests in any intellectual
property rights for which some or all of such intellectual property rights are
to be owned by or licensed to Exelixis pursuant to the terms of this Agreement,
BMS will, where and to the extent expressly provided in this Agreement, assign
or license same to Exelixis as provided in this Agreement and will confirm same
in writing if requested by Exelixis.
3.2    Grant by Exelixis.
(a)    Subject to the terms of this Agreement, Exelixis hereby grants, and shall
cause its Affiliates to grant, to BMS a non-exclusive, worldwide,
non-transferable, royalty-free license (with the right to sublicense solely
pursuant to the terms of and subject to the limitations of Section 3.3) under
the Exelixis Independent Patent Rights, Exelixis Technology, and Exelixis
Regulatory Documentation to use the Exelixis Compound, solely to the extent
necessary to discharge BMS’s obligations under this Agreement with respect to
the conduct of the Combined Therapy Trials.
(b)    To the extent that a CRO, contractor or Combined Therapy Trial study site
assigns or licenses to Exelixis any title, rights or interests in any
intellectual property rights for which some or all of such intellectual property
rights are to be owned by or licensed to BMS pursuant to the terms of this
Agreement, Exelixis will, where and to the extent expressly provided in this

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Agreement, assign or license same to BMS as provided in this Agreement and will
confirm same in writing if requested by BMS.
3.3    Sublicensing.
(a)    Each Party shall have the right to grant sublicenses, under the licenses
granted to it under Section 3.1 and Section 3.2, to Affiliates and to Third
Parties, solely to the extent required for a Third Party to perform its duties
with respect to the conduct of the Combined Therapy Trials (and, for Third Party
sublicenses, if agreed to by the other Party, such consent not to be
unreasonably withheld, conditioned or delayed), solely as necessary to assist a
Party in carrying out its responsibilities with respect to the Combined Therapy
Trials.
(b)    For the avoidance of doubt, (i) in no event shall BMS (or any of its
sublicensees) have the right to grant Ono or any of Ono’s Affiliates any
sublicense under the licenses granted to BMS in Section 3.2, without the prior
written consent of Exelixis, and (ii) in no event shall Exelixis (or any of its
sublicensees) have the right to grant Ipsen, Takeda or any of their respective
Affiliates any sublicense under the licenses granted to Exelixis in Section 3.2,
without the prior written consent of BMS.
(c)    With regard to any such sublicenses permitted and made under this
Agreement, (i) such sublicensees, except Affiliates (so long as they remain
Affiliates of a Party), shall be subject to written agreements that bind such
sublicensees to obligations that are consistent with a Party’s obligations under
this Agreement including, but not limited to, confidentiality and non-use
provisions no less restrictive than those set forth in Sections 8.2 and 8.3 and
Article 9, and provisions regarding intellectual property that ensure that the
Parties will have the rights provided under this Agreement to any intellectual
property created by such sublicensee, (ii) each Party shall provide written
notice to the other of any such sublicense (and obtain approval for sublicenses
to Third Parties); and (c) the licensing Party shall remain liable for all
actions of its sublicensees.
3.4    No Implied Licenses. Except as specifically set forth in this Agreement,
neither Party shall acquire any license or other intellectual property interest,
by implication or otherwise, in any intellectual property of the other Party,
including Confidential Information disclosed to it under this Agreement or under
any Patent Rights Controlled by the other Party or its Affiliates.
ARTICLE 4
MANUFACTURE AND SUPPLY
4.1    Exelixis Compound.
(a)    Manufacture and Supply. Exelixis shall Manufacture or have Manufactured
the Exelixis Compound in drug product and/or drug substance form (as necessary)
in reasonable quantities and at the points in time as agreed by the JDC for each
Combined Therapy Trial, and, as applicable, shall supply such Exelixis Compound
to BMS or its designee for use in the Combined Therapy Trials. As applicable,
BMS will package and label the Exelixis Compound

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for use in the Combined Therapy Trial, subject to Section 4.1(b). The cost of
Manufacture and supply (including shipping, taxes and duty, if applicable) of
Exelixis Compound for the Combined Therapy Trials shall be borne solely by
Exelixis, and Exelixis shall bear the risk of loss for the Exelixis Compound
until delivery of the Exelixis Compound to the common carrier for delivery to
BMS or its designee. Exelixis shall also be responsible for the payment of any
Third Party License Payments that may be due exclusively on the supply of
Exelixis Compound for the Combined Therapy Trials. Exelixis shall also be
responsible for the payment of any Third Party License Payments that may be due
based on the manufacture, supply and use of the Exelixis Compound used in the
Combined Therapy Trials. The Exelixis Compound shall be manufactured in
accordance with Applicable Law (including GMP) and shall be of similar quality
to the Exelixis Compound used by Exelixis for its other clinical trials of the
Exelixis Compound. Exelixis shall deliver certificates of analysis, and any
other documents specified in the Quality Agreement between Exelixis and BMS.
Exelixis shall be responsible for the quality of the Exelixis Compound provided
to BMS with the appropriate regulatory filings in the countries where each of
the Combined Therapy Trials are performed, pursuant to the Quality Agreement.
The Parties shall cooperate in accordance with Applicable Law to minimize
indirect taxes (such as value added tax, sales tax, consumption tax and other
similar taxes) relating to the Exelixis Compound in connection with this
Agreement. Exelixis will inform BMS as to the GMP Manufacturing and testing site
of bulk drug substance for the Exelixis Compound, as well as the Exelixis
Compound drug product GMP Manufacturing and testing site, prior to the start of
the Combined Therapy Trials and provide [ * ] advance written notice of any
change to these site(s).
(b)    Packaging Costs for Exelixis Compound. Notwithstanding Section 4.1(a),
Exelixis will reimburse BMS for the costs incurred by it for any packaging and
labeling by BMS of the Exelixis Compound provided by Exelixis for use in the
Combined Therapy Trials (“Section 4.1(b) Costs”). For purposes of this
Agreement, “Section 4.1(b) Costs” shall mean fully-burdened costs, as determined
by BMS [ * ] in accordance with generally accepted accounting principles in the
United States (“GAAP”), [ * ].
(c)    Use of Exelixis Compound Supplied by Exelixis to BMS. BMS shall use the
quantities of Exelixis Compound supplied to it under this Agreement solely as
necessary for, and in accordance with, this Agreement and the Protocols, and for
no other purpose, including without limitation as a reagent or tool to
facilitate its internal research efforts, for any commercial purpose, or for
other research unrelated to the Combined Therapy Trials. Except as may be
required under this Agreement, a Bioanalysis Plan, or a Protocol, BMS shall not
perform, and shall not allow any Third Parties to perform, any analytical
testing of the quantities of Exelixis Compound supplied to it under this
Agreement.
4.2    BMS Compound(s).
(a)    Manufacture and Supply. BMS shall Manufacture or have Manufactured the
BMS Compound(s) in drug substance and/or drug product form (as necessary) in
reasonable quantities and at the points in time as agreed by the JDC for each
Combined Therapy Trial, and, as applicable, shall supply such BMS Compound(s) in
unmarked vials or as labeled commercial product

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to Exelixis or its designee for use in the Combined Therapy Trials. As
applicable, Exelixis will package and label the BMS Compound(s) for use in the
Combined Therapy Trial, subject to Section 4.2(b). The cost of Manufacture and
supply (including shipping, taxes and duty, if applicable) of the BMS
Compound(s) for the Combined Therapy Trials shall be borne solely by BMS, and
BMS shall bear the risk of loss for the BMS Compound(s) until delivery of the
BMS Compound(s) to the common carrier for delivery to Exelixis or its designee.
BMS shall also be responsible for the payment of any Third Party License
Payments that may be due to Ono or to others exclusively on the supply of BMS
Compound(s) hereunder for the Combined Therapy Trials. BMS shall be responsible
for the payment of any Third Party License Payments that may be due based on the
manufacture, supply and use of the BMS Compound(s) used in the Combined Therapy
Trials. The BMS Compound(s) shall be Manufactured in accordance with Applicable
Law (including GMP) and shall be of similar quality to the BMS Compound(s) used
by BMS for its other clinical trials of the BMS Compound(s). BMS shall deliver
certificates of analysis, and any other documents specified in the Quality
Agreement. BMS shall be responsible for the regulatory compliance of the quality
of the BMS Compound(s) provided to Exelixis with the regulatory filings in the
countries where each of the Combined Therapy Trials are performed, pursuant to
the Quality Agreement. The Parties shall cooperate in accordance with Applicable
Law to minimize indirect taxes (such as value added tax, sales tax, consumption
tax and other similar taxes) relating to the BMS Compound(s) in connection with
this Agreement. Exelixis. BMS will inform Exelixis to the GMP Manufacturing and
testing site of bulk drug substance for the BMS Compound(s), as well as the BMS
Compound(s) drug product GMP Manufacturing and testing site, prior to the start
of the Combined Therapy Trials and provide [ * ] advance written notice of any
change to these site(s).
(b)    Packaging Costs for the BMS Compounds. Notwithstanding Section 4.2(a),
BMS will reimburse Exelixis for the costs incurred by it for any packaging and
labeling by Exelixis of the vials of the BMS Compound(s) for use in the Combined
Therapy Trials (“Section 4.2(b) Costs”). For purposes of this Agreement,
“Section 4.2(b) Costs” shall mean fully-burdened costs, as determined by
Exelixis [ * ] in accordance with GAAP, [ * ].
(c)    Use of BMS Compound(s) Supplied by BMS to Exelixis. Exelixis shall use
the quantities of BMS Compound(s) supplied to it under this Agreement solely as
necessary for, and in accordance with, this Agreement and the Protocols, and for
no other purpose, including without limitation as a reagent or tool to
facilitate its internal research efforts, for any commercial purpose, or for
other research unrelated to the Combined Therapy Trials. Except as may be
required under this Agreement, a Bioanalysis Plan, or a Protocol, Exelixis shall
not perform, and shall not allow any Third Parties to perform, any analytical
testing of the quantities of BMS Compound(s) supplied to it under this
Agreement.
4.3    Quality Agreement/Quality Addendum. Within [ * ] after the Effective
Date, but in no event later than the date on which the first shipment of bulk
Exelixis Compound or bulk BMS Compound is supplied for use in the Combined
Therapy Trials, the Parties shall enter into a quality agreement or quality
addendum (in either case, the “Quality Agreement”). In addition, the Quality
Agreement shall detail the documentation required for each shipment of BMS
Compound supplied

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to Exelixis and Exelixis Compound supplied to BMS, or their respective
designees, for use in the Combined Therapy Trials. The Quality Agreement shall
also indicate whether any required transfer from BMS to Exelixis of analytical
methods will be necessary to support identity testing of the BMS Compound(s) by
Exelixis and vice versa.
4.4    Supply Agreement. Within [ * ] after the Effective Date but in no event
later than the date on which the first shipment of bulk Exelixis Compound or
bulk BMS Compound is supplied for use in the Combined Therapy Trials, the
Parties shall enter into a supply agreement (the “Supply Agreement”) governing
forecasting, ordering, procedures for acceptance and rejection, and other
customary provisions for the supply of the BMS Compound(s) and the Exelixis
Compound for the Combined Therapy Trials.
4.5    Customs Valuation. The Conducting Party will provide the Non-Conducting
Party in writing with a list of all countries participating in a Combined
Therapy Trial prior to study start Initiation of such Combined Therapy Trial.
During the conduct of such Combined Therapy Trial, the Conducting Party will
send in writing any changes to the list of participating countries to the
Non-Conducting Party [ * ] prior to the end of each Quarter. If no changes are
sent to the Non-Conducting Party by the Conducting Party for a particular
Quarter, the prior Quarter’s participating country list will be used as the
basis for customs valuation for that Quarter. The Non-Conducting Party will
provide the Conducting Party with its Compound country-specific customs
valuations initially prior to study start initiation of Combined Therapy
Trial(s) and at the end of each Quarter during the conduct of the Combined
Therapy Trial. The Conducting Party will use the Non-Conducting Party provided
values for the import/export process to the listed participating countries and
not make any change to such valuations without the Non-Conducting Party’s prior
written consent.
ARTICLE 5
RESPONSIBILITIES
5.1    Specific Responsibilities of the Parties. Subject to the terms of this
Agreement, each Party shall use Commercially Reasonable Efforts to (i) supply
the quantities of its Compound(s) as needed to conduct a Combined Therapy Trial
on a timely basis, and package and deliver same to study sites, in accordance
with the time frame(s) established by the JDC ; (ii) to conduct and complete
each Combined Therapy Trial and any Statistical Analysis Plans and Bioanalysis
Plans relating thereto on a timely basis in accordance with the Protocol,
Bioanalysis Plans, Statistical Analysis Plans and Third Party agreements
relating thereto, (iii) to timely provide Rights of Cross-Reference where
required by this Agreement, and (iv) in the case of the Conducting Party, to
provide sufficient resources and personnel to conduct and perform the Combined
Therapy Trial for which it is the Conducting Party, and to adequately fund the
Combined Therapy Trial, on a timely basis in accordance with the Protocol for
same and the terms of this Agreement.
 

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Each Party shall be responsible for activities assigned to it by the JDC in
furtherance of the conduct of a Combined Therapy Trial, or the Statistical
Analysis Plan that such Party is not otherwise obligated to perform by this
Agreement, provided that, except as expressly set forth in this Agreement, in no
event shall either Party be obligated to perform any such assigned activities
without its prior written consent (which may be reflected in the minutes of
meetings of the JDC and signed by both representatives). As of the Effective
Date, each Party shall be responsible for the following activities:
(a)    Responsibilities of the Conducting Party. Subject to JDC direction and
oversight as provided in Section 2.4, the Conducting Party shall be responsible
for the following activities (except as expressly provided in Article 4 with
respect to the Manufacture and supply of the Non-Conducting Party Compound(s)):
(i)    (A) manufacturing, packaging and labeling GMP-grade quantities of the
Conducting Party Compound(s), and packaging and labeling of the Combined Therapy
for use in the Combined Therapy Trials, (B) packaging and labeling the vials, if
applicable, provided by the Non-Conducting Party of the Non-Conducting Party
Compound(s) for use in the Combined Therapy Trials, (C) providing the JDC with
prompt notice of any Manufacturing and supply issues with respect to the
Conducting Party’s Compound that may adversely impact the conduct or timelines
of a Combined Therapy Trial, and (D) providing the Non-Conducting Party with
clinical drug supply forecasts and drug delivery dates for the Non-Conducting
Party Compound(s) (which shall be set forth more fully in the Supply Agreement);
(ii)    with the cooperation of the Non-Conducting Party, compiling, amending
and filing all necessary Combined Therapy Trial Regulatory Documentation with
Regulatory Authority(ies), maintaining and acting as the sponsor of record as
provided in 21 CFR 312.50 (and applicable comparable ex-US laws) with
responsibility, unless otherwise delegated in accordance with 21 CFR 312.52 (and
applicable comparable ex-US laws), for each Combined Therapy Trial and making
all required submissions to Regulatory Authorities related thereto on a timely
basis;
(iii)    with Non-Conducting Party cooperation, and subject to the provisions of
Section 9.6, listing any Combined Therapy Trial required to be listed on a
public database on www.clinicaltrials.gov or other public registry in any
country in which such Combined Therapy Trial is being conducted in accordance
with Applicable Law and in accordance with each Party’s internal policies
relating to clinical trial registration;
(iv)    providing the Non-Conducting Party with reasonable advance notice of
scheduled meetings or other material non-written communications with a
Regulatory Authority and the opportunity to participate in each such meeting (to
the extent permitted by Applicable Law and such Regulatory Authority) or other
non-written communication, to the extent that it relates to the conduct of the
Combined Therapy Trial or the Non-Conducting Party Compound(s) and providing
such opportunity to participate in such meetings (to the extent permitted by
Applicable Law and such Regulatory Authority) to Ipsen (only for meetings with
Regulatory Authorities in the

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Ipsen Territory) and Takeda (only for meetings with Regulatory Authorities in
the Takeda Territory) where Exelixis is the Non-Conducting Party and Ono (only
for meetings with Regulatory Authorities in the Ono Territory) where BMS is the
Non-Conducting Party provided that the Non-Conducting Party provides advance
notice to Ipsen, Takeda or Ono, as applicable, of such opportunity, however,
before participating in any such meeting, each representative of Ipsen, Takeda
or Ono, as applicable, must be bound by a written agreement having
confidentiality and use obligations that apply to Confidential Information of
BMS and/or Exelixis, that are at least as restrictive as those binding upon
Exelixis and BMS in this Agreement and that cover the meetings with the
applicable Regulatory Authority, and, unless otherwise agreed by the JDC,
providing the Non-Conducting Party with the opportunity to review, provide
comments to the Conducting Party within [ * ] on, and, if inconsistent with the
applicable Protocol(s) or JDC guidance, approve all submissions and written
correspondence with a Regulatory Authority that relates to the conduct of the
Combined Therapy Trial or the Non-Conducting Party Compound(s); provided,
however, in no event shall the Conducting Party or any Affiliate of the
Conducting Party communicate with any Regulatory Authority solely with respect
to the Non-Conducting Party Compound(s) without the prior written consent of the
Non-Conducting Party and provided further that the Non-Conducting Party shall
step out of any portions of such meetings or other non-written communications
with a Regulatory Authority that relate solely to the Conducting Party
Compound(s) and the Conducting Party shall step out of any portions of such
meetings or other non-written communications with a Regulatory Authority that
relate solely to the Non-Conducting Party Compound(s);
(v)    unless otherwise agreed by the JDC, providing to the Non-Conducting Party
a written summary of meetings or other non-written communications with a
Regulatory Authority within [ * ] of such meeting or communication, and copies
of any official correspondence to or from a Regulatory Authority within [ * ] of
a Party’s receipt or provision of such correspondence, in each case to the
extent that it relates to the Combined Therapy or the Non-Conducting Party
Compound(s) (or, to the extent the communication would adversely impact the
performance of the Combined Therapy Trial, the Conducting Party Compound(s)),
and copies of all Combined Therapy Trial Regulatory Documentation that relate to
the Combined Therapy or the Non-Conducting Party’s Compound(s) within [ * ] of
submission to Regulatory Authorities;
(vi)    drafting, and, subject to the terms of this Agreement, providing to the
Non-Conducting Party (through the JDC or otherwise) for its review and approval,
each Protocol (including any immunogenicity analysis plan) and investigator’s
brochure for a Combined Therapy Trial, and the related template informed consent
form, template clinical site agreement, Bioanalysis Plan and Statistical
Analysis Plan, and any amendments to each of the foregoing.
(vii)    unless otherwise agreed by the JDC, coordinating with the
Non-Conducting Party and providing to the JDC (or a subcommittee or working
group designated by the JDC for such purpose) [ * ] in advance of submission
(timeline may be shortened if required per Regulatory Authority request and if
agreed by JDC), drafts of (1) submissions to the Combined Therapy IND (if
applicable); and (2) Combined Therapy Trial Regulatory Documentation, or
portions thereof, that relate to the Combined Therapy or the Non-Conducting
Party Compound(s),

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for JDC review and approval, and providing the Non-Conducting Party with the
opportunity to review, comment on and approve all other written correspondence
with a Regulatory Authority relating to the Combined Therapy Trials, to the
extent such correspondence relates to the Combined Therapy or the Non-Conducting
Party Compound(s);
(viii)    managing the operations of the Combined Therapy Trials in accordance
with the applicable Protocol, including overseeing compliance by any CRO with
the terms of its agreement with the Conducting Party relating to the Combined
Therapy Trial;
(ix)    subject to the terms of this Agreement, providing to the Non-Conducting
Party a list of all proposed clinical trial sites and principal investigator(s)
for each Combined Therapy Trial;
(x)    subject to the terms of this Agreement, ensuring that all clinical trial
service agreements and clinical trial site agreements (A) contain intellectual
property provisions that retain each of the Parties’ respective intellectual
property rights in the Exelixis Compound, the BMS Compound(s) and Combined
Therapy, and (B) allow for BMS, Exelixis to the extent permitted by applicable
law and any Third Party confidentiality restrictions or obligation, to audit
Combined Therapy Trial study sites for quality assurance and to inspect and copy
all data, documentation and work products relating to the activities performed
by the site, including, without limitation, the medical records of any patient
participating in any clinical study. This right to inspect and copy all data,
documentation, and work products of a study site may be exercised at any time
during the term of this Agreement, or such longer period as shall be required by
Applicable Law; provided, however, that where the Non-Conducting Party wants to
exercise any of such rights with respect to the Combined Therapy Trial for which
it is the Non-Conducting Party, it must first discuss the right(s) it wants to
exercise and the Conducting Party must agree to the exercise of such right(s)
before the Non-Conducting Party can exercise those rights.
(xi)    providing the Non-Conducting Party with copies of each final site
template ICF (if requested by the Non-Conducting Party);
(xii)    providing the Non-Conducting Party with minutes from any and all
external drug safety monitoring boards for the Combined Therapy Trials, if
applicable, within [ * ] after receipt by BMS;
(xiii)    providing the Non-Conducting Party with updates on the status of the
Combined Therapy Trials at each teleconference for the clinical execution
working group, or upon the Non-Conducting Party’s reasonable request, including
but not limited to information regarding the number and status of study sites,
the number of screened subjects (actual to target), the number of randomized
subjects (actual to target), the number of dosed, ongoing, discontinued and
completed subjects, and any safety updates as contemplated by the applicable
Protocol, Pharmacovigilance Agreement, and/or routinely performed by a Party in
its normal course of trial management and reporting;

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(xiv)    subject to the provisions of Section 2.2 and the Pharmacovigilance
Agreement, owning and being responsible for (or appointing a Third Party
reasonably acceptable to the Non-Conducting Party to be responsible for) the
maintenance of the Global Safety Database and safety reporting for the Combined
Therapy, collecting, evaluating and reporting serious adverse events, other
safety data and any further pharmacovigilance information from the Conducting
Party sponsored Combined Therapy Trials, and providing the Non-Conducting Party
with the opportunity to participate in and comment on such pharmacovigilance
activities;
(xv)    providing the Non-Conducting Party with prompt notice and copy of any
updates to the Investigator’s Brochure for the Conducting Party Compound(s)) and
an opportunity to discuss same with a senior Conducting Party executive
responsible for same if requested by the Non-Conducting Party;
(xvi)    analyzing the Study Data in a timely fashion and providing the
Non-Conducting Party with access to the Study Data from the applicable Combined
Therapy Trial as follows:
(1)    pursuant to an appropriate timetable determined by the JDC: (A) sharing
with the Non-Conducting Party for review and comment drafts of interim and/ or
final clinical trial report (and/or statistical analysis in accordance with the
Statistical Analysis Plan) from each Combined Therapy Trial and (B) providing
the raw Study Data in electronic or other mutually agreed format;
(2)    when the final clinical trial report, CSR, or other final summary, such
as a Summary of Clinical Safety, for a Combined Therapy Trial is provided to the
Non-Conducting Party, the Conducting Party shall also provide to the
Non-Conducting Party the Study Data Tabulation Model (SDTM) and the Analysis
Data Model (ADaM) data sets used to generate such report or summary, Define.xml
files for the SDTM and the ADaM data sets, a Study Data Reviewers Guide, an
Analysis Data Reviewers Guide, a blank CRF, and an SDTM-annotated CRF; all data
and information for cohorts that are  not part of the Combined Therapy Trial
will be redacted from the foregoing; and prior to the finalization of such final
CSR or other final summary, the Conducting Party shall provide to the
Non-Conducting Party up to two blinded drafts (from which data and information
for cohorts that are not part of the Combined Therapy Trial are redacted) of the
Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data sets
used to generate the report or summary unless the Protocol for such Combined
Therapy Trial provides otherwise or the JDC agrees otherwise that more than two
drafts will be provided and/or that one or both drafts will not be blinded;
(3)    within [ * ] after database lock, access to safety databases that will be
used for an interim review by an external consultant (or drug safety monitoring
board, if required) to be agreed upon by the Parties;
(4)    within [ * ] after database lock, access to case report forms or patient
profiles for all patients in each Combined Therapy Trial; and

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(5)    within [ * ] of the creation of a clean database for the Combined Therapy
Trial, copies of the Form 1572s, financial disclosures and other relevant
documents required to meet regulatory requirements related to the Combined
Therapy Trials (including without limitation any data or documents that may be
required to provide Aggregate Safety Information to a Regulatory Authority with
respect to the Non-Conducting Party Compound(s);
(6)    within [ * ] of the creation of an electronic clean database for the
Combined Therapy Trial, an electronic copy of the clean database (it being
understood that the form and format of the clean database must be reasonable
acceptable to all Parties and shall be determined by the JDC); and
(7)    subject to any third party requirements, providing the Non-Conducting
Party with any programs or SAS codes to be used for the Statistical Analysis
Plan for the Combined Therapy Trial;
(xvii)    obtaining supplies of any co-medications, to the extent any such
co-medications are required for use in any Combined Therapy Trial, and providing
to the Non-Conducting Party any information related to each Combined Therapy
Trial that is provided to the manufacturer of any co-medication pursuant to
Section 9.5 herein within [ * ] after the provision of the information to the
manufacturer;
(xviii)    providing the Non-Conducting Party with any information regarding the
pharmacokinetics, efficacy and safety of the Conducting Party Compound(s) alone
or in combination with the Non-Conducting Party Compound(s);
(xix)    performing either directly or through third parties collection of
Samples;
(xx)    providing the Non-Conducting Party, where and to the extent provided in
the Quality Agreement and based on the Non-Conducting Party sampling
instructions, with samples of the Non-Conducting Party Compound(s) (bulk and
post packaging material) for analytical identification testing performed by the
Non-Conducting Party; and
(xxi)    such other responsibilities as may be agreed to by the Parties or
determined by the JDC.
(b)    Responsibilities of the Non-Conducting Party. Subject to JDC direction as
provided in Section 2.4, the Party that is not the Conducting Party for a
Combined Therapy Trial (the “Non-Conducting Party”) shall be responsible for the
following activities, subject in each case (except as expressly provided in
Article 4 with respect to the Manufacture and supply of the Non-Conducting Party
Compound(s)) to sharing by the Parties of the Shared Study Costs related to such
activities in accordance with Section 7.1:

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(i)    manufacturing and supplying GMP-grade quantities of of the Non-Conducting
Party Compound(s), as further described in Article 4 above, and, where and to
the extent provided in the Quality Agreement, providing necessary GMP
information and documentation that enables the Conducting Party to release the
Non-Conducting Party Compound(s) for the Combined Therapy Trial;
(ii)    where and to the extent provided in the Quality Agreement, providing for
the release by a Qualified Person (as such term will be defined in the Quality
Agreement) or providing the necessary documentation in support of such quality
release, of the Non-Conducting Party Compound(s) if such release is required for
any Combined Therapy Trial;
(iii)     performing analytical/biological testing of samples taken by the
Conducting Party for the purpose of identification of the Non-Conducting Party
Compound(s) after receipt at the Conducting Party and after clinical packaging
by the Conducting Party. The Non-Conducting Party will provide the results to
the Conducting Party that allows the Conducting Party a timely release of the
Non-Conducting Party Compound(s) for packaging operation and shipment to the
clinical sites.
(iv)     promptly reviewing and approving each Protocol (including any
immunogenicity analysis plan) and investigator’s brochure for a Combined Therapy
Trial, and the related template informed consent form, Bioanalysis Plan and
Statistical Analysis Plan, and any amendments to each of the foregoing (provided
that the Non-Conducting Party shall provide the Conducting Party with written
notice of any comments or objections within [ * ] of the date on which the
Conducting Party provides the applicable document to the Non-Conducting Party);
(v)    to the extent necessary for the conduct of any Combined Therapy Trial,
providing a Right of Cross-Reference to the relevant Regulatory Documentation
for the Non-Conducting Party Compound(s), provided that, except as provided in
Section 3.1 and Section 3.2 (as applicable), such Right of Cross-Reference shall
terminate upon the expiration or termination of this Agreement for purposes of
conducting any new clinical studies (except as otherwise expressly provided in
this Agreement), except that in the case of termination for a Material Safety
Issue pursuant to Section 12.4, such Right of Cross-Reference shall remain in
effect solely (1) to the extent necessary to permit the Conducting Party to
comply with any outstanding obligations required by a Regulatory Authority
and/or Applicable Law or (2) as necessary to permit the Conducting Party to
continue to dose subjects enrolled in each Combined Therapy Trial through
completion of the applicable Protocol if required by the applicable Regulatory
Authority(ies) and/or Applicable Laws;
(vi)     unless otherwise agreed by the JDC, jointly reviewing, providing
comments to the Conducting Party within [ * ] on, and approving all Combined
Therapy Trial Regulatory Documentation and providing the Conducting Party with
copies of the Non-Conducting Party Regulatory Documentation, as both Parties
agree is necessary or reasonably expected to be necessary, and is requested by
the Conducting Party, (1) to obtain and maintain the IND for the Combined
Therapy Trials and prepare and file any Combined Therapy Trial Regulatory

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Documentation in accordance with this Agreement, or (2) to comply with
Applicable Law with regard to the Conducting Party Compound(s) and the Combined
Therapy Trials, which may include information regarding the pharmacokinetics,
efficacy and safety of the Non-Conducting Party Compound(s) alone or in
combination with the Conducting Party Compound(s) (provided that the
Non-Conducting Party shall provide the Conducting Party with written notice of
any such comments (and, where applicable, approvals or rejections) within [ * ]
of the date on which the Conducting Party provides the applicable document to
the Non-Conducting Party;
(vii)    analyze clinical PK Samples with the Non-Conducting Party Compound(s)
assay and provide data and data analysis to the Conducting Party;
(viii)    providing comment and input on the management of each Combined Therapy
Trial pursuant to the applicable Protocol;
(ix)    reviewing and, if applicable, suggesting alternatives to the Conducting
Party’s proposed list of principal investigator(s) for each Combined Therapy
Trial;
(x)    providing the Conducting Party with access to an investigator’s brochure
for the Non-Conducting Party Compound(s) as determined by the Non-Conducting
Party (and any updates thereto);
(xi)    providing and making available as necessary information and/or persons
with knowledge concerning the Non-Conducting Party Compound(s) to support the
Combined Therapy Trial, including any interactions with a Regulatory Authority;
(xii)    providing to the JDC (or a subcommittee or working group designated by
the JDC for such purpose) with prompt notice of any interactions with Regulatory
Authorities relating to the Non-Conducting Party Compound(s) that might
reasonably be expected to materially impact Combined Therapy Trial; and
(xiii)    such other responsibilities as may be agreed to by the Parties or
determined by the JDC.
5.2    Documents and Combined Therapy Trial Contracts.

(a)    The Parties agree that the Conducting Party shall bear as a sponsor,
primary responsibility for conduct of each Combined Therapy Trial and the
analysis of the Study Data under the applicable Statistical Analysis Plan. In
consultation with the Non-Conducting Party, the Conducting Party shall draft the
Protocols and Statistical Analysis Plans, and any amendments to each of the
foregoing, and shall provide such documents to the Non-Conducting Party for
review, comment, and if applicable, approval as provided in this Agreement. The
Non-Conducting Party shall have [ * ] from the date on which the Conducting
Party provides the applicable document to the Non-Conducting Party to provide
any comments and if applicable, approvals or rejections, to the Conducting Party
concerning the applicable draft Protocol or Statistical Analysis Plan, or any
amendment to each of the foregoing.

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(b)    Subject to the terms of this Agreement, the Conducting Party shall be
responsible for negotiating and entering into contracts for services relating to
the Combined Therapy Trials, including selecting vendors, approving contract
deliverables and managing contract performance, including site contracts,
obtaining IRB approval for site informed consent forms, obtaining signed
informed consents, monitoring plans, etc. The Conducting Party will be
responsible for ensuring that any such contracts (i) do not conflict with the
terms of this Agreement, (ii) allow the Conducting Party to provide the
Non-Conducting Party with access to and use of Study Data, Samples, and other
information and documents as required pursuant to this Agreement (and in no
event not less than the same access or use as is granted the Conducting Party)
(iii) in the case of Exelixis as Conducting Party, do not adversely affect the
BMS Technology or BMS Independent Patent Rights (or the enforcement or defense
thereof), the Combined Therapy, or the BMS Compound as monotherapy, (iv) in the
case of BMS as Conducting Party, do not adversely affect the Exelixis Technology
or Exelixis Independent Patent Rights (or the enforcement or defense thereof),
the Combined Therapy, or the Exelixis Compound as monotherapy, (v) do not impose
a new obligation, whether direct, indirect, or contingent, upon the
Non-Conducting Party that is not set forth in this Agreement, and (vi) do not
confer a benefit upon the Conducting Party that is not also conferred upon the
Non-Conducting Party.
5.3    Other Clinical Trials. Except for the Combined Therapy Trials, each
clinical trial for the BMS Compound(s) and the Exelixis Compound, alone or in
combination with other pharmaceutical agents, is independently conducted and
shall not be subject to this Agreement (but without limiting each Party’s
obligation to share relevant safety information as provided in this Agreement,
the Quality Agreement or the Pharmacovigilance Agreement). BMS Compound(s)
provided to Exelixis and Exelixis Compound provided to BMS under this Agreement
shall not be used for such other clinical trials. Nothing in this Agreement
shall preclude a Party from conducting any such other clinical trials as it may
determine in its discretion, so long as it does not use or rely on the
Confidential Information of the other Party in doing so.

5.4    Additional Combined Therapy Trials If the Parties jointly agree to
conduct any further Combined Therapy Trials beyond the Initial Trials, if
necessary, the Pharmacovigilance Agreement and the Quality Agreement shall be
amended to provide for such Combined Therapy Trial under the terms thereof. In
addition, the Parties agree to discuss whether it may be useful or desirable to
include Ono, Ipsen and/or Takeda as part of any such further Combined Therapy
Trial.
ARTICLE 6
INTELLECTUAL PROPERTY
6.1    Inventions. All rights to Inventions shall be allocated as follows:
(a)    Exelixis Ownership. Subject to the terms of this Agreement, all Exelixis
Study Inventions shall be owned by Exelixis, and Exelixis will have the full
right to exploit such Exelixis Study Inventions without the consent of, or any
obligation to account to, BMS. BMS shall assign and hereby assigns (and shall
cause its Affiliates and contractors to assign) all right, title and

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interest in any Exelixis Study Inventions to Exelixis. Any assignments necessary
to accomplish the foregoing are hereby made, and BMS shall execute such further
documents and provide other assistance as may be reasonably requested by
Exelixis to perfect Exelixis’s rights in such Exelixis Study Inventions, all at
Exelixis’s expense (as applicable). Exelixis shall have the sole right but not
the obligation to prepare, file, prosecute (including any proceedings relating
to reissues, reexaminations, protests, interferences, oppositions, post-grant
reviews or similar proceedings and requests for patent extensions) and maintain
any Exelixis Study Patent Rights at its own expense.
(b)    BMS Ownership. Subject to the terms of this Agreement, all BMS Study
Inventions shall be owned solely by BMS, and BMS will have the full right to
exploit such BMS Study Inventions without the consent of, or any obligation to
account to, Exelixis. Exelixis shall assign and hereby assigns (and shall cause
its Affiliates and contractors to assign) all right, title and interest in any
BMS Study Inventions to BMS. Any assignments necessary to accomplish the
foregoing are hereby made, and Exelixis shall execute such further documents and
provide other assistance as may be reasonably requested by BMS to perfect BMS’
rights in such BMS Study Inventions, all at BMS’ expense. BMS shall have the
sole right but not the obligation to prepare, file, prosecute (including any
proceedings relating to reissues, reexaminations, protests, interferences,
oppositions, post-grant reviews or similar proceedings and requests for patent
extensions) and maintain any BMS Study Patent Rights at its own expense.
(c)    Combined Therapy Inventions. All Combined Therapy Inventions shall be
jointly owned by the Parties (BMS to own 50% and Exelixis to own 50%), and any
Party shall have the right to freely practice and exploit the Combined Therapy
Inventions and Combined Therapy Patent Rights worldwide, both within and outside
the scope of this Agreement, without accounting or any other obligation to the
other Party (except as expressly set forth in Section 6.1(d) and Section 6.3(d)
with regard to the filing, prosecution, maintenance and enforcement of Combined
Therapy Patent Rights) and each Party may use, exploit and grant licenses
worldwide (with right to sublicense) to Third Parties under its interest in such
Combined Therapy Trial Inventions and Combined Therapy Patent Rights without the
consent of the other Party or any consideration or any accounting or any other
obligation to the other Party. For the avoidance of doubt, neither Party shall
acquire any other license or other intellectual property interest, by
implication or otherwise, in any intellectual property of the other Party under
this Section 6.1(c), including but not limited to Exelixis Independent Patent
Rights, Exelixis Study Patent Rights, BMS Independent Patent Rights, or BMS
Study Patent Rights.
(d)    Prosecution of Combined Therapy Patent Rights. The Parties shall agree as
to which of BMS or Exelixis, using outside counsel acceptable to the other
Party, shall be responsible for preparing and prosecuting Patent applications
and maintaining Patents within the Combined Therapy Patent Rights. The Party
drafting and prosecuting any Combined Therapy Patent Right (the “Prosecuting
Party”) shall keep the other Party (the “Non-Prosecuting Party”) advised as to
material developments and all steps to be taken with respect to any such Patents
and shall furnish the Non-Prosecuting Party with copies of applications for such
Patents, amendments thereto and other related correspondence to and from Patent
offices, and permit the Non-Prosecuting

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Party a reasonable opportunity to review and offer comments. The Non-Prosecuting
Party shall reasonably assist and cooperate in obtaining, prosecuting and
maintaining the Combined Therapy Patent Rights. Notwithstanding the foregoing,
the Prosecuting Party shall not take any position in a submission to a Patent
office that interprets the scope of a Patent or Patent application of the
Non-Prosecuting Party without the prior written consent of such Non-Prosecuting
Party. The Prosecuting Party shall be reimbursed for any costs and expenses
incurred in prosecuting Combined Therapy Patent Rights and the subsequent
maintenance of Combined Therapy Patent Rights by the Non-Prosecuting Party such
that BMS shall be responsible for [ * ] of such costs and Exelixis shall be
responsible for [ * ] of such costs. In case either BMS or Exelixis decides not
to file or maintain a Combined Therapy Patent Right application in a given
country (and also elects not to reimburse the other Party for [ * ] of the costs
of prosecution and maintenance of such Combined Therapy Patent Right in such
country), the other Party shall have the right to file or maintain such patent
application in such country in its own name and at its own expense upon the
prior consent of the other Party, which shall not be unreasonably withheld or
delayed. In this case, the Party who decides not to file or maintain (and also
decides not to reimburse the other Party for its share of the costs of) a joint
application for a given country shall promptly assign its rights to the joint
invention in said country to the Party who wishes to file or maintain said
patent application. The Party who does not wish to file or maintain a patent
application in any country shall assist in the timely provision of all documents
required under national provisions to register said assignment of rights with
the corresponding national authorities at the sole expense of the Party who
wishes to file or maintain such patent application in that given country. If the
Parties cannot agree with respect to the decision to file or maintain a Combined
Therapy Patent Right within [ * ] subsequent to the initiation of the Parties’
good faith efforts to resolve any disagreement, then either BMS or Exelixis
shall have the right to file or maintain any patent application for the Combined
Therapy Patent Right in the names of the Parties, provided that: (i) any
resulting Patent shall be deemed to be a Combined Therapy Patent Right hereunder
and shall be jointly owned by BMS and Exelixis and subject to the freedom to use
and operate under such Combined Therapy Patent Right as set forth in the first
sentence of this Section 6.1(c), and the Non-Prosecuting Party shall reimburse
the Prosecuting Party for its 50% share of the patent costs.
(e)    Separation of Patent Rights. In order to more efficiently enable the
prosecution and maintenance of the BMS Study Patent Rights, Exelixis Study
Patent Rights and Combined Therapy Patent Rights relating to Inventions as
described above, the Parties will use good faith efforts to separate BMS Study
Patent Rights, Exelixis Study Patent Rights, Combined Therapy Patent Rights, BMS
Independent Patent Rights and Exelixis Independent Patent Rights into separate
patent filings to the extent possible and without adversely impacting such
prosecution and maintenance.
6.2    Disclosure and Assignment of Inventions. Each Party shall disclose
promptly to the other Party in writing and on a confidential basis all
Inventions, prior to any public disclosure or filing of Patent applications and
allowing sufficient time for comment by the other Party. In addition, each Party
shall, and does hereby, assign, and shall cause its Affiliates and contractors
to so assign, to the applicable Party, without additional compensation, such
right, title and interest in

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and to any Inventions as well as any intellectual property rights with respect
thereto, as is necessary to fully effect, as applicable, the sole ownership
provided for in Sections 6.1(a) and 6.1(b) and the joint ownership provided for
in Section 6.1(c).
6.3    Infringement of Patent Rights by Third Parties.
(a)    Notice. Each Party shall promptly notify the other Party in writing of
any alleged or threatened (in writing) infringement, or misappropriation by a
Third Party, of Combined Therapy Patent Rights, of which its in-house patent
counsel becomes aware (such infringement, “Infringement,” and “Infringe” shall
be interpreted accordingly).
(b)    Infringement of Exelixis Study Patent Rights. For all Infringement of
Exelixis Study Patent Rights anywhere in the world, Exelixis shall have the
exclusive right to prosecute such Infringement as it may determine in its sole
and absolute discretion, and Exelixis shall bear all related expenses and retain
all related recoveries. BMS shall reasonably cooperate with Exelixis or their
designee (to the extent BMS has relevant information arising out of this
Agreement), at the request and expense of Exelixis, in any such action.
(c)    Infringement of BMS Study Patent Rights. For all Infringement of BMS
Study Patent Rights anywhere in the world, BMS shall have the exclusive right to
prosecute such Infringement as it may determine in its sole and absolute
discretion, and BMS shall bear all related expenses and retain all related
recoveries. Exelixis shall reasonably cooperate with BMS or its designee (to the
extent Exelixis has relevant information arising out of this Agreement), at BMS’
request and expense, in any such action.
(d)    Infringement of Combined Therapy Patent Rights.
(i)    With respect to Infringement of Combined Therapy Patent Rights, the
Parties shall mutually agree as to whether to bring an enforcement action to
seek the removal or prevention of such Infringement and damages therefor and, if
so, which Party shall bring such action, with any costs and expenses relating
thereto to be allocated in accordance with Section 6.3(d)(ii).
(ii)    Regardless of which Party brings an enforcement action pursuant to
Section 6.3(d)(i), the other Party hereby agrees to cooperate reasonably in any
such action, including, if required, by bringing a legal action or furnishing a
power of attorney. If the Parties mutually agree to bring an enforcement action,
BMS shall be responsible for [ * ], and Exelixis shall be responsible for [ * ],
of the reasonable and verifiable costs and expenses incurred in connection with
any such action. If any Party recovers monetary damages from any Third Party in
an action approved by the Parties and brought under this Section 6.3(d)(ii),
such recovery shall be allocated first to the reimbursement of any actual,
unreimbursed costs and expenses incurred by the Parties in such litigation
(including, for this purpose, a reasonable allocation of expenses of internal
counsel) pro rata in accordance with the aggregate amounts spent by both
Parties, and any remaining amounts shall be split [ * ] to

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Exelixis and [ * ] to BMS, unless the Parties agree in writing to a different
allocation. In connection with any proceeding under this Section 6.3(d), neither
Party shall enter into any settlement without the prior written consent of the
other Party.
6.4    Infringement of Third Party Rights.
(a)    Notice. If the activities relating to the Combined Therapy Trials become
the subject of a claim of infringement of a patent, copyright or other
proprietary right by a Third Party anywhere in the world, the Party first having
notice of the claim shall promptly notify the other Party and, without regard to
which Party is charged with said infringement and the venue of such claim, the
Parties shall promptly confer to discuss the claim.
(b)    Defense. If all of the Parties are charged with infringement pursuant to
a claim described in Section 6.4(a), the Parties shall defend such claim
jointly, unless they agree otherwise. If only one Party is charged with
infringement, such Party will have the first right but not the obligation to
defend such claim. If the charged Party does not commence actions to defend such
claim within [ * ] after being so charged, then the other Party shall have the
right, but not the obligation, to defend any such claim. In any event, a
non-defending Party shall reasonably cooperate with the Party conducting the
defense of the claim and shall have the right to participate with separate
counsel at its own expense, and the defending Party shall consider comments and
suggestions on strategy for defending the action by a non-defending Party in
good faith. The Party defending the claim shall bear the cost and expenses of
the defense of any such Third Party infringement claim and shall have sole
rights to any recovery. If the Parties jointly defend the claim, Exelixis shall
bear [ * ], and BMS shall bear [ * ] of any costs and expenses of the defense of
any such Third Party infringement claim; provided, however, that,
notwithstanding the foregoing, if the claim relates solely to either the BMS
Compound(s) or the Exelixis Compound, BMS or Exelixis (as applicable) will bear
[ * ] of the costs and expenses of the defense of such claim and shall have the
sole right, but not the obligation, to defend, settle and otherwise handle the
disposition of such claim. No Party shall enter into any settlement concerning
activities under this Agreement or the Combined Therapy that affects the other
Party’s rights under this Agreement or imposes any obligations on the other
Party, including any admissions of wrongdoing on behalf of the other Party,
without such other Party’s prior written consent, not to be unreasonably
withheld or delayed, except that (i) Exelixis may settle any claim that solely
relates to the Exelixis Compound without the consent of BMS as long as BMS’s
rights under this Agreement are not materially adversely impacted (in which
case, it will obtain BMS’s prior written consent, not to be unreasonably
withheld or delayed) and (ii) BMS may settle any claim that solely relates to
the BMS Compound(s) without the consent of Exelixis as long as Exelixis rights
under this Agreement are not materially adversely impacted (in which case, it
will obtain Exelixis prior written consent, not to be unreasonably withheld or
delayed).
6.5    Combined Therapy Trial Regulatory Documentation. Subject to the license
and other rights granted by each Party to the other Party pursuant to this
Agreement, the Parties shall jointly own (BMS to own 50% and Exelixis to own
50%) all right, title and interest in and to the Combined Therapy Trial
Regulatory Documentation; provided, however, that BMS shall retain sole and
exclusive ownership of any BMS Regulatory Documentation provided to Exelixis
under this

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Agreement that is submitted with or referenced in the Combined Therapy Trial
Regulatory Documentation and that Exelixis shall retain sole and exclusive
ownership of any Exelixis Regulatory Documentation that is submitted with or
referenced in the Combined Therapy Trial Regulatory Documentation. This Section
6.5 is without limitation of any other disclosure obligations under the
Pharmacovigilance Agreement or this Agreement.
6.6    No Other Use. Except as expressly provided in Section 6.1 Exelixis agrees
to make no patent application based on BMS Confidential Information, and to give
no assistance to any Third Party for such application without BMS’s prior
written authorization, and BMS agrees to make no patent application based on
Exelixis Confidential Information, and to give no assistance to any Third Party
for such application without Exelixis’ prior written authorization.
6.7    Joint Research Agreement. The Parties acknowledge and agree that this
Agreement is a “Joint Research Agreement” as defined in 35 USC § 100 (h).

ARTICLE 7
COLLABORATION COSTS AND EXPENSES
7.1    Combined Therapy Trial Expenses. BMS and Exelixis will share the Shared
Costs (in accordance with Section 7.2), with BMS responsible for fifty percent
(50%) and Exelixis responsible for fifty percent (50%) of the Shared Costs for
each control arm and each double therapy arm (i.e., Cabozantinib + Nivolumab or
Cabozantinib + Ipilimumab) of each Combined Therapy Trial and with BMS
responsible for sixty-seven percent (67%) and Exelixis responsible for
thirty-three percent (33%) of the Shared Costs for each triple therapy arm
(i.e., Cabozantinib + Nivolumab + Ipilimumab) of a Combined Therapy Trial. The
cost allocation (on a percent basis) for the Shared Costs of each Combined
Therapy Trial will be calculated prior to the initiation or an amendment of such
Combined Therapy Trial and will be the weighted percentages for BMS’ share and
for Exelixis’s share of such Combined Therapy Trial, with such weighted
percentages calculated on the basis of [ * ] and the applicable allocation
percentages above in this Section 7.1 for each arm of such Combined Therapy
Trial. The weighted percentages calculated before the initiation of a Combined
Therapy Trial will not change and will be applied to all of the Shared Costs of
such Combined Therapy Trial unless the number of arms in such Combined Therapy
Trial increases or decreases, in which case the weighted percentages will be
recalculated and applied to all subsequent Shared Costs for such Combined
Therapy Trial (with the weighted percentages being recalculated and applied
thereafter whenever there is a change in the number of arms in such Combined
Therapy Trial). By way of illustration, if there are [ * ], then the weighted
percentage for BMS at the initiation of such Combined Therapy Trial would be
calculated as follows:
[ * ].

The weighted percentage for Exelixis would be [ * ].    

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7.2     Each Party shall calculate Shared Costs in accordance with GAAP. “Shared
Costs” means the costs directly attributable or reasonably allocable by each
Party (both out-of-pocket and internal) for the conduct of the Combined Therapy
Trial (including but not limited to [ * ]) based on [ * ]. The Shared Costs
shall be incurred consistent with the JDC‑approved budget for such Shared Costs.
The final budget for each Combined Therapy Trial will be based on the final
Protocol for such Combined Therapy Trial and will be subject to approval by the
JDC. For clarity, expenses incurred as described in Article 4 (regarding
manufacturing and supply), and Article 6 (regarding intellectual property) shall
not be considered “Shared Costs” but shall be borne or shared by the Parties as
provided in such Articles.  In addition, each Party shall bear its own Third
Party License Payments as set forth in Section 2.5(b).  For the avoidance of
doubt, nothing in this Agreement herein shall be considered to establish an
employment relationship between a Party and the FTEs of the other Party funded
by such Party pursuant to this Agreement.
7.3    Invoicing; Payment.  
(a)    Reporting and Invoicing.  Each Party shall report to the other Party,
within [ * ] after the end of each Quarter with regard to Shared Costs and
Section 4.1(b) Costs or Section 4.2(b) Costs (as applicable) actually incurred
during such Quarter by such Party (a “Quarterly Report”).  Such report shall
specify in reasonable detail such Shared Costs and Section 4.1(b) Costs or
Section 4.2(b) Costs (as applicable) during such Quarter.  The Parties shall
seek to resolve any questions related to such reports within [ * ] following
receipt by each Party of the other Party’s report hereunder.  Based on these
reports, the Parties finance teams will determine the amount, if any, owed by
BMS, on the one hand, and Exelixis on the other hand, for such Quarter and a
“True-Up Payment” will be made by BMS if owing same or Exelixis if owing same
within [ * ] after the receipt of an invoice for such True-Up Payment from BMS
or Exelixis, whichever is applicable. 
(b)    Budget Overruns.  Any costs for a given budget that are incurred by a
Party that are [ * ] greater than the JDC-approved budget shall require approval
of the JDC for payment.  The Parties shall bear the cost of any such overrun
equally; provided, however, that if the reason for the costs exceeding the
JDC-approved budget by more than [ * ] is attributable to [ * ], then the costs
incurred that are more than [ * ] greater than the JDC-approved budget for such
item shall be [ * ]. 
7.4    Audit.   At the request (and expense) of a Party, the other Party shall
permit an independent certified public accountant appointed by the requesting
Party and reasonably acceptable to such other Party, at reasonable times and
upon reasonable notice, to examine only those records as may be reasonably
necessary to determine, with respect to any calendar year ending not more than [
* ] prior to such Party’s request, the correctness or completeness of any
invoice submitted to the such other Party or other payment made to the such
other Party pursuant to this Agreement.  The foregoing right of review may be
exercised only once per year and only once with respect to each such periodic
report and payment.  Results of any such examination shall be (a) made available
to both Parties and (b) subject to Article 9.  The Party requesting the audit
shall bear the full cost of the performance of any such audit, unless such audit
discloses a variance to the detriment of the auditing Party of more than [ * ]
from the amount of the original report, royalty or payment

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calculation, in which case, the Party being audited shall bear the full cost of
the performance of such audit.

ARTICLE 8
RECORDS AND STUDY DATA
8.1    Records. Each Party shall maintain complete and accurate records of all
work conducted with respect to the Combined Therapy Trials and of all results,
information, data, data analyses, reports, records, methods, processes,
practices, formulae, instructions, skills, techniques, procedures, experiences
and developments made by or provided to either Party, or by the Parties
together, in the course of such Party’s efforts with respect to the Combined
Therapy Trials (including the Statistical Analysis Plan and any Bioanalysis Plan
to be conducted pursuant to this Agreement) (such results, information, data,
data analyses, reports, case report forms, adverse event reports, trial records,
methods, processes, practices, formulae, instructions, skills, techniques,
procedures, experiences, developments, and each Combined Therapy Trial protocol
referred to as the “Study Data”). Such records shall fully and properly reflect
all work done and results achieved in the performance of the Combined Therapy
Trials in sufficient detail and in good scientific manner appropriate for patent
and regulatory purposes.

8.2    Ownership of Study Data. BMS shall own the Study Data to the extent that
it relates exclusively to the BMS Compound (“BMS Study Data”), and Exelixis
shall own the Study Data to the extent that it relates exclusively to the
Exelixis Compound (“Exelixis Study Data”). The Parties shall jointly own (BMS to
own 50% and Exelixis to own 50%) any Study Data that does not relate exclusively
to the Exelixis Compound or the BMS Compound (“Combined Therapy Study Data”).
Each Party shall, and does hereby, assign, and shall cause its Affiliates to so
assign, to the other Party, without additional compensation, such right, title
and interest in and to any Study Data as is necessary to fully effect the
foregoing, and agrees to execute all instruments as may be reasonably necessary
to effect same.
  
8.3    Use of Study Data.
 
(a)    Use of a Party’s Own Study Data. BMS may use and analyze the BMS Study
Data for any purpose without obligation or accounting to Exelixis. Exelixis may
use and analyze the Exelixis Study Data for any purpose without obligation or
accounting to BMS.
(b)    Use of Combined Therapy Study Data by BMS. BMS, Ono and their respective
Affiliates and (sub)licensees of the BMS Compound shall have the right to use
and analyze the Combined Therapy Study Data for any and all purposes without the
consent of, or any obligation to account to, Exelixis, including (x) in
connection with their independent development, commercialization or other
exploitation of the BMS Compound(s) (alone or in combination with the Exelixis
Compound and/or other pharmaceutical agents) and/or for inclusion in the safety

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database for the BMS Compound, and (y) to conduct studies with Samples pursuant
to Section 8.5. Subject to Section 8.5, the results of all such uses or analyses
shall be owned by BMS, including any intellectual property arising out of same,
unless the Parties shall have agreed otherwise in writing.
(c)    Use in Regulatory Filings by BMS. In addition, BMS, Ono and their
respective Affiliates and (sub)licensees of the BMS Compound(s) shall be
entitled to use the Combined Therapy Study Data during and following the term of
this Agreement to (1) submit regulatory filings and seek approvals for the BMS
Compound(s), either as monotherapy or as part of the Combined Therapy and (2)
following the applicable approval of the Combined Therapy, to promote
indications based on, and to disseminate, the Combined Therapy Study Data for
the benefit of the BMS Compound(s) as part of the Combined Therapy, where
permitted by and in accordance with Applicable Law. In the case where BMS
submits Combined Therapy Study Data to a Regulatory Authority in a filing for
approval for the use of the BMS Compound(s) in combination with the Exelixis
Compound (including any reference to the Combined Therapy Study Data in its
label) or if required by the applicable Regulatory Authority, then BMS shall be
granted a Right of Cross-Reference to the relevant Regulatory Documentation
Controlled by Exelixis for the Exelixis Compound and the Combined Therapy solely
to the extent required for the purpose of such approval (which right shall
survive any expiration or termination of this Agreement). In such case, Exelixis
shall reasonably cooperate with BMS and make written authorizations and other
filings with the applicable Regulatory Authority reasonably required to effect
such Right of Cross-Reference. Such grant to BMS of a Right of Cross-Reference
shall not include a Right of Cross-Reference for use in the Takeda Territory,
without Exelixis’ prior written consent.
(d)    Use of Combined Therapy Study Data by Exelixis. Exelixis and its
Affiliates and licensees of the Exelixis Compound shall have the right to use
and analyze the Combined Therapy Study Data for any and all purposes without the
consent of, or any obligation to account to, BMS, including (x) in connection
with their independent development, commercialization or other exploitation of
the Exelixis Compound (alone or in combination with the BMS Compound(s) and/or
other pharmaceutical agents and/or for inclusion in the safety database for the
Exelixis Compound, and (y) to conduct studies with Samples pursuant to Section
8.5. Subject to Section 8.5, the results of all such uses or analyses shall be
owned by Exelixis, including any intellectual property arising out of same,
unless the Parties shall have agreed otherwise in writing.
(e)    Use in Regulatory Filings by Exelixis. In addition, Exelixis and its
Affiliates and licensees of the Exelixis Compound shall be entitled to use the
Combined Therapy Study Data during and following the term of this Agreement to
(1) submit regulatory filings and seek approvals for the Exelixis Compound,
either as monotherapy or as part of the Combined Therapy and (2) following the
applicable approval of the Combined Therapy, to promote indications based on,
and to disseminate, the Combined Therapy Study Data for the benefit of the
Exelixis Compound as part of the Combined Therapy, where permitted by and in
accordance with Applicable Law. In the case where Exelixis submits Combined
Therapy Study Data to a Regulatory Authority

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in a filing for approval for the use of the Exelixis Compound in combination
with the BMS Compound(s) (including any reference to the Combined Therapy Study
Data in its label), then Exelixis shall be granted a Right of Cross-Reference to
the relevant Regulatory Documentation Controlled by BMS for the BMS Compound and
the Combined Therapy solely to the extent required for the purpose of such
approval (which right shall survive any expiration or termination of this
Agreement) or if required by the applicable Regulatory Authority. In such case,
BMS shall reasonably cooperate with Exelixis and make written authorizations and
other filings with the applicable Regulatory Authority reasonably required to
effect such Right of Cross-Reference. Such grant to Exelixis of a Right of
Cross-Reference shall not include a Right of Cross-Reference for use in the Ono
Territory, without BMS’ prior written consent.
(f)    Biomarker/Dx Agent Development. Each Party may use and disclose to a
Third Party the Combined Therapy Study Data and its Compound(s)’s Study Data,
under obligations of confidentiality consistent with this Agreement, to develop
and commercialize a biomarker or diagnostic test for use with its Compound(s)
and/or the Combined Therapy, and, unless otherwise mutually agreed by the
Parties in writing, will own any intellectual property arising out of the work
funded or conducted by it with or through such Third Party. The Parties will
discuss in good faith any opportunities to jointly participate in the
development of any such biomarker or diagnostic test for use with the Combined
Therapy.
(g)    No Other Uses. All other uses of Study Data are limited solely to those
permitted by this Agreement, and neither Party may use Study Data for any other
purpose without the consent of the other Party during and after the Term of this
Agreement.
8.4    Access to Study Data. Subject to the provisions of Sections 5.1, and the
Pharmacovigilance Agreement, each Party shall have access to all Study Data
(including, but not limited to, de-identified patient records) as soon as such
Study Data is available to or generated by the Party responsible for generating
or collecting such Study Data.
8.5    Samples. Samples collected in the course of activities conducted under
this Agreement shall be jointly owned by the Parties (BMS to own 50% and
Exelixis to own 50%) (to the extent not owned by the patient and/or the clinical
trial site). Any such Samples shall be collected in accordance with the
applicable Protocol and ICFs. Except as set forth in a Bioanalysis Plan, no
Party shall be permitted to use such Samples for any purpose without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld if such use is directed to the Combined Therapy and with the terms of
such use to be set forth in a written agreement between the Parties setting
forth the Samples to be used, and any appropriate terms/restrictions on such
use. Any data and intellectual property arising out of such Sample use shall be
owned by the Party conducting such study using same; provided, that to the
extent that any such data or intellectual property relates solely to the
Combined Therapy (or biomarkers solely for use with the Combined Therapy), shall
be considered Combined Therapy Study Data or Combined Therapy
Inventions/Combined Therapy Patent Rights, as the case may be. Samples [ * ]
will be stored for future use [ * ], provided, that [ * ], provided further that
[ * ]. If no Party has any further use for the Samples, then the remaining
Samples will be destroyed pursuant to the respective Party’s standard operating

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procedures for sample retention and destruction, subject to the terms of and
permission(s) granted in the informed consent forms signed by the subjects
contributing the Samples in the Combined Therapy Trials.
8.6    For the avoidance of doubt, all bioanalytical results for the BMS
Compound(s) and the Exelixis Compound(s) from Samples from Combined Therapy
Trial subjects are deemed to be Study Data.  All data derived pursuant to the
Protocol from such Samples from Combined Therapy Trial subjects are deemed to be
Study Data.
8.7    Where a Combined Therapy Trial is added to a pre-existing clinical trial
of one of the Parties, none of the cohorts of such pre-existing clinical trial
shall be part of the Combined Therapy Trial and none of the results,
information, data, data analyses, reports, records, methods, processes,
practices, formulae, instructions, skills, techniques, procedures, experiences
and developments from such cohorts will be Study Data unless the Protocol
expressly provides that any such cohort and any such results, information, data,
data analyses, reports, records, methods, processes, practices, formulae,
instructions, skills, techniques, procedures, experiences and developments are
part of the Combined Therapy Trial or Study Data, respectively. Where a cohort
of a Combined Therapy Trial is a monotherapy cohort with just the Exelixis
Compound or with just one of the BMS Compounds or is a double therapy cohort
with just the BMS Compounds, then the Study Data from such cohort will be
Exelixis Study Data in the case where such cohort is a monotherapy cohort with
just the Exelixis Compound and BMS Study Data in the case where such cohort is a
monotherapy cohort with just one of the BMS Compounds or is a double therapy
cohort with just the BMS Compounds, and such Exelixis Study Data will be made
available to BMS and such BMS Study Data will be made available to Exelixis upon
request by BMS or Exelixis, respectively, and shall be used by BMS and Exelixis,
respectively, solely to analyze and estimate the contribution of components in
the Combined Therapy, and such Exelixis Study Data and such BMS Study Data is
Confidential Information of Exelixis and Confidential Information of BMS,
respectively.

ARTICLE 9
CONFIDENTIALITY
9.1    Nondisclosure of Confidential Information. Prior to the Effective Date of
this Agreement, Exelixis and BMS entered into a certain Confidentiality
Agreement having an effective date of June 9, 2016, as amended by Amendment No.
1 to Confidentiality Agreement having an effective date of February 2, 2017
(“CDA”). As it relates to disclosures involving the BMS Compound and the
Exelixis Compound only, the CDA is hereby terminated and replaced by the terms
of this Agreement. Any Confidential Information relating thereto previously
disclosed by the Parties pursuant to the CDA shall now be Confidential
Information for purposes of this Agreement and the Parties shall treat it as
such in accordance with the terms hereof. All written, visual, oral and
electronic data, information, know-how or other proprietary information or
materials, both technical and non-technical, disclosed by one Party to any other
Party pursuant to

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this Agreement that (a) if in tangible form, is labeled in writing as
“proprietary” or “confidential” (or similar reference); or (b) if in oral or
visual form, is identified as proprietary or confidential or for internal use
only at the time of disclosure or within [ * ] thereafter shall be “Confidential
Information” of the disclosing Party, and all Study Data and Inventions shall be
the Confidential Information of the Party owning such Study Data or Invention
(as provided in Section 8.2 with regard to Study Data and Section 6.1 with
regard to Inventions). For purposes of this Agreement, regardless of which Party
discloses such Confidential Information to the other, (i) all Exelixis Study
Inventions, Exelixis Technology and Exelixis Regulatory Documentation shall be
Confidential Information of Exelixis and BMS shall be the receiving Party, (ii)
all BMS Study Inventions, BMS Technology, and BMS Regulatory Documentation shall
be Confidential Information of BMS and Exelixis shall be the receiving Parties.
Except to the extent expressly authorized in this Section 9.1 and Sections 9.2,
9.3 and 9.6 below, or as otherwise agreed in writing by the Parties, each Party
agrees that, for the Term of this Agreement and for a period of [ * ] thereafter
(or for any Confidential Information that is identified in writing at the time
of disclosure as a trade secret related to each Party’s Compound(s), for as long
as it is not part of the public domain), it shall (x) keep confidential and
shall not publish or otherwise disclose and shall not use for any purpose other
than as expressly provided for in this Agreement any Confidential Information
owned solely by any other Party, (y) treat any other Party’s solely-owned
Confidential Information with the same degree of care the receiving Party uses
for its own confidential information but in no event with less than a reasonable
degree of care; and (z) reproduce a disclosing Party’s solely-owned Confidential
Information solely to the extent necessary to accomplish the receiving Party’s
obligations under this Agreement, with all such reproductions being considered
the disclosing Party’s Confidential Information; provided, that [ * ],
Confidential Information that was [ * ]. Notwithstanding anything to the
contrary in this Section 9.1, and subject to Section 8.3, the receiving Party
may disclose a disclosing Party’s Confidential Information to its employees,
consultants, agents or permitted sublicensees solely on a need-to-know basis for
the purpose of fulfilling the receiving Party’s obligations or exercising the
receiving Party’s rights under this Agreement; provided, however, that (1) any
such employees, consultants, agents or permitted sublicensees are bound by
obligations of confidentiality at least as restrictive as those set forth in
this Agreement, and (2) the receiving Party remains liable for the compliance of
such employees, consultants, agents or permitted sublicensees with such
obligations. Each receiving Party acknowledges that in connection with its and
its representatives examination of the Confidential Information of the
disclosing Party, the receiving Party and its representatives may have access to
material, non-public information, and that the receiving Party is aware, and
will advise its representatives who are informed as to the matters that are the
subject of this Agreement, that State and Federal laws, including, without
limitation, United States securities laws, impose restrictions on the
dissemination of such information and trading in securities when in possession
of such information. Each receiving Party agrees that it will not, and will
advise its representatives who are informed as to the matters that are the
subject of this Agreement to not, purchase or sell any security of the
disclosing Party on the basis of the Confidential Information to the extent such
Confidential Information constitutes material non-public information about the
disclosing Party or such security.

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Combined Therapy Study Data shall be treated as Confidential Information of each
Party and shall not be disclosed to Third Parties unless it falls within the
exceptions set forth in Section 9.2 below or is reasonably necessary to be
disclosed in order for a Party to exercise its rights under Section 8.3(b),
8.3(c), 8.3(d) or 8.3(e).
9.2    Exceptions. The obligations in Section 9.1 shall not apply with respect
to any portion of Confidential Information that the receiving Party can
demonstrate by contemporaneous tangible records or other competent proof:
(a)    was already known to the receiving Party (or its Affiliates), other than
under an obligation of confidentiality, either (a) at the time of disclosure by
the disclosing Party, or (b) if applicable, at the time that it was generated
hereunder, whichever ((a) or (b)) is earlier;
(b)    was generally available to the public or otherwise part of the public
domain either (a) at the time of its disclosure to the receiving Party, or (b)
if applicable, at the time that it was generated hereunder, whichever ((a) or
(b)) is earlier;
(c)    became generally available to the public or otherwise part of the public
domain after its disclosure (including via publication under Section 9.6) and
other than through any unauthorized act or omission of the receiving Party in
breach of this Agreement;
(d)    was disclosed to the receiving Party (or its Affiliates), other than
under an obligation of confidentiality, by a Third Party who had no obligation
to the Party owning or Controlling the information not to disclose such
information to others; or
(e)    was independently discovered or developed by the receiving Party (or its
Affiliates) without the use of or reference to the Confidential Information
belonging to the disclosing Party.
9.3    Authorized Disclosure. Notwithstanding any other provision of this
Agreement, each Party may disclose Confidential Information belonging to the
other Party to the extent such disclosure is reasonably necessary in the
following instances:
(a)    filing or prosecuting Patent Rights claiming an Invention owned by such
Party;
(b)    prosecuting or defending litigation;
(c)    complying with Applicable Law or the rules or regulations of any
securities exchange on which such Party’s stock is listed;
(d)    disclosure, in connection with the performance of this Agreement, to
Affiliates, permitted sublicensees, contractors, ethics committees and
institutional review boards (collectively, “IRBs”), CROs, academic institutions,
consultants, agents, investigators, and employees and contractors engaged by
Study sites and investigators involved with the Combined

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Therapy Trials, each of whom prior to disclosure must be bound by similar terms
of confidentiality and non-use at least equivalent in scope to those set forth
in this Article 9;
(e)    disclosure of the Combined Therapy Study Data, Combined Therapy
Inventions and Combined Therapy Patent Rights to Regulatory Authorities in
connection with the development of the Combined Therapy, the Exelixis Compound
or the BMS Compound; and
(f)    disclosure of relevant safety information contained within the Combined
Therapy Study Data to investigators, institutional review boards and/or ethics
committees and Regulatory Authorities that are involved in other clinical trials
of the Exelixis Compound with respect to Exelixis, and the BMS Compound with
respect to BMS, and (in the event of a Material Safety Issue) to Third Parties
that are collaborating with Exelixis or BMS, respectively in the conduct of such
other clinical trials of the Exelixis Compound or the BMS Compound(s), in each
case solely to the extent necessary for the conduct of such clinical trials
and/or to comply with Applicable Law and regulatory requirements.
Notwithstanding the foregoing, if a Party is required or otherwise intends to
make a disclosure of any other Party’s Confidential Information pursuant to
Section 9.3(b) and/or Section 9.3(c), it shall give advance notice to such other
Party of such impending disclosure and endeavor in good faith to secure
confidential treatment of such Confidential Information and/or reasonably assist
the Party that owns such Confidential Information in seeking a protective order
or other confidential treatment.
9.4    Disclosure to Ono. Notwithstanding any other provision of this Agreement,
Exelixis hereby expressly authorizes BMS to disclose to Ono (i) this Agreement,
the Protocols, Combined Therapy Inventions and Combined Therapy Patent Rights
and (ii) any other Exelixis Confidential Information necessary for BMS to
fulfill its obligations to Ono under the Ono-BMS Agreements; provided that Ono
is under confidentiality obligations at least as restrictive as set forth
herein. BMS shall be free to disclose the BMS Study Data and the Combined
Therapy Study Data to Ono as BMS may determine as provided in Section 8.3(b) or
8.3(c) and otherwise to fulfill its obligations under the Ono-BMS Agreements.
9.5    Disclosure to Ipsen and Takeda. Notwithstanding any other provision of
this Agreement, BMS hereby expressly authorizes Exelixis to disclose to Ipsen
and Takeda (i) this Agreement, the Protocols, Combined Therapy Inventions and
Combined Therapy Patent Rights and (ii) any other BMS Confidential Information
necessary for Exelixis to fulfill its obligations to Ipsen and Takeda under the
Ipsen-Exelixis Agreements and the Takeda-Exelixis Agreements; provided that
Ipsen and Takeda are each under confidentiality obligations at least as
restrictive as set forth herein. Exelixis shall be free to disclose the Exelixis
Study Data and the Combined Therapy Study Data to Ipsen and Takeda as Exelixis
may determine as provided in Section 8.3(d) or 8.3(e) and otherwise to fulfill
its obligations under each of the the Ipsen-Exelixis Agreements and the
Takeda-Exelixis Agreements.
9.6    Disclosure to Third Party Co-Medication Manufacturer. Notwithstanding any
other provision of this Agreement, the Non-Conducting Party hereby authorizes
the Conducting

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Party to disclose to the manufacturer of any co-medication necessary for each
Combined Therapy Trial the applicable Protocol and any related Confidential
Information necessary for such manufacturer to update its product label if such
disclosure is necessary to obtain the co-medication for use in such Combined
Therapy Trial; provided, however, that all materials delivered to such
manufacturer will be redacted of all non-public information related to the
Non-Conducting Party’s Compound(s). Any such disclosure shall be subject to
confidentiality obligations at least as restrictive as those set forth herein
and shall restrict the manufacturer to using the information provided solely to
make regulatory filings relating to the use of the applicable co-medication in
such Combined Therapy Trial.
9.7    Press Releases and Publications.
(a)    The Parties shall jointly agree to the content and timing of all external
communications with respect to this Agreement (including, without limitation, an
initial press release, the content of which shall be as attached hereto as
Exhibit D, subsequent press releases, Q&As, and the content and wording for of
any listing any Combined Therapy Trial required to be listed on a public
database or other public registry such as www.clinicaltrials.gov). For clarity,
if either Party terminates this Agreement pursuant to Section 12.4, the Parties
shall mutually agree upon any external communication related to such
termination, which shall not include the rationale for such termination unless
(and to the extent) mutually agreed by the Parties; provided that either Party
shall be permitted to publicly disclose information that such Party determines
in good faith is necessary to be disclosed to comply with Applicable Law or the
rules or regulations of any securities exchange on which such Party’s stock may
be listed, or pursuant to an order of a court or governmental entity.
(b)    Exelixis and BMS agree to collaborate to publicly disclose, publish or
present (1) top-line results from each Combined Therapy Trial, limited if
possible to avoid jeopardizing the future publication of the Study Data at a
scientific conference or in a scientific journal, solely for the purpose of
disclosing, as soon as reasonably practicable, the safety or efficacy results
and conclusions that are material to any Party under applicable securities laws,
and (2) the conclusions and outcomes (the “Results”) of each Combined Therapy
Trial at a scientific conference as soon as reasonably practicable following the
completion of such Combined Therapy Trial, subject in the case of (2) to the
following terms and conditions. The Party proposing to disclose, publish or
present the Results shall deliver to each other Party a copy of the proposed
disclosure, publication or presentation at least [ * ] before submission to a
Third Party. Each reviewing Party shall determine whether any of its
Confidential Information that may be contained in such disclosure, publication
or presentation should be modified or deleted, whether to file a patent
application on any Exelixis Study Invention (solely with respect to Exelixis) or
BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention
disclosed therein. The disclosure, publication or presentation shall be delayed
for an additional [ * ] (i.e., a total of [ * ] from the initial proposal) if a
reviewing Party reasonably requests such extension to allow time for the
preparation and filing of relevant patent applications. If a reviewing Party
reasonably requests modifications to the disclosure, publication or presentation
to prevent the disclosure of a material trade secret or proprietary business

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information, the publishing Party shall edit such publication to prevent the
disclosure of such information prior to submission of the disclosure,
publication or presentation. In the event of a disagreement as to content,
timing and/or venue or forum for any disclosure, publication or presentation of
the Results, such dispute (a “Publication Dispute”) shall be referred to the
Executive Officers (or their respective designees); provided that, in the
absence of agreement after such good faith discussions, and upon expiration of
the additional [ * ], (A) academic collaborators engaged by the Conducting Party
in connection with the performance of the Combined Therapy Trials may publish
Combined Therapy Study Data obtained by such academic collaborator solely to the
extent that such ability to publish such Combined Therapy Study Data is set
forth in an agreement between the Conducting Party and such academic
collaborator relating to the conduct of Combined Therapy Trials and (B) the
publishing Party may proceed with the disclosure, publication or presentation
provided that such disclosure, publication or presentation is consistent with
its internal publication guidelines and customary industry practices for the
publication of similar data. Authorship of any publication shall be determined
based on the accepted standards used in peer-reviewed academic journals at the
time of the proposed disclosure, publication or presentation. The Parties agree
that they shall make reasonable efforts to prevent publication of a press
release that could jeopardize the future publication of Study Data at a
scientific conference or in a scientific journal but in no way will this or any
other provision of this Agreement supersede the requirements of any Applicable
Law or the rules or regulations of any securities exchange or listing entity on
which a Party’s stock is listed (including, but not limited to, any such rule or
regulation that may require a Party to make public disclosures about interim
results of a Combined Therapy Trial). Notwithstanding the foregoing, Exelixis
hereby authorizes disclosure to Ono in accordance with Section 9.4 above, and
BMS hereby authorized disclosure to Ipsen and Takeda in accordance with Section
9.5 above. Notwithstanding the foregoing, nothing herein shall prevent or
restrict Ono, Ipsen or Takeda from making any disclosures of published Study
Data disclosed to it by BMS pursuant to Section 9.4 or Exelixis pursuant to
Section 9.5 of the existence of this Agreement, in each case in order for Ono,
Ipsen or Takeda to comply with requirements of Applicable Law, the rules or
regulations of any securities exchange or listing entity on which its stock may
be traded or pursuant to an order of a court or governmental entity to publicly
disclose the existence of the Agreement and the Study Data.
9.8    Compliance with Sunshine Laws.
(a)    For purposes of compliance with reporting obligations under Sunshine
Laws, as between the Parties, the Conducting Party will report payments or other
transfers of value (“POTV”) made by the Conducting Party or the CRO related to
the conduct of the Combined Therapy Trials and any applicable associated
contractor engagements as required under the Sunshine Laws for each Combined
Therapy Trial. Interpretation of the Sunshine Laws for purposes of reporting any
POTV by a Party shall be in such Party’s sole discretion so long as the
interpretation complies with Applicable Law.
(b)    The Conducting Party (i) will provide (to the extent in the possession of
the Conducting Party), or will utilize Commercially Reasonable Efforts to
obligate and ensure that each CRO and other applicable Third Party contractors
for a Combined Therapy Trial provides, the Non-

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Conducting Party with any information requested by the Non-Conducting Party as
the Non-Conducting Party may reasonably determine for the Non-Conducting Party
to comply with its reporting obligations under Sunshine Laws (with such amounts
paid to, or at the direction of, each Recipient to be reported to the
Non-Conducting Party within a reasonable time period specified by the
Non-Conducting Party) and (ii) will reasonably cooperate with, and will utilize
Commercially Reasonable Efforts to obligate and ensure that each CRO and other
applicable Third Party contractors for a Combined Therapy Trial reasonably
cooperates with, the Non-Conducting Party in connection with its compliance with
such Sunshine Laws. The form in which the Conducting Party provides any such
information shall be mutually agreed but sufficient to enable the Non-Conducting
Party to comply with its reporting obligations and the Non-Conducting Party may
disclose any information that it believes is necessary to comply with Sunshine
Laws. Without limiting the foregoing, the Non-Conducting Party shall have the
right to allocate payments or other transfers of value in connection with this
Agreement in any required reporting under Sunshine Laws in accordance with its
normal business practices. These obligations shall survive the expiration and
termination of the agreement to the extent necessary for the Non-Conducting
Party to comply with Sunshine Laws.
(c)    For purposes of this Section 9.7, “Sunshine Laws” means Applicable Laws
requiring collection, reporting and disclosure of POTVs to certain healthcare
providers, entities and individuals. These Applicable Laws may include, without
limitation, relevant provisions of the Patient Protection and Affordable Health
Care Act of 2010 and implementing regulations thereunder. “Recipients” means
healthcare providers, teaching hospitals and/or any other persons for whom
transfers of value or payments must be reported under Sunshine Laws.
9.9    Destruction of Confidential Information. Upon expiration or termination
of the Agreement, the receiving Party shall, upon request by the other Party,
immediately destroy or return all of the other Party’s Confidential Information
relating solely to its Compound(s) as monotherapy (but not to the Combined
Therapy or the Combined Therapy Study Data) in its possession; provided,
however, that the receiving Party shall be entitled to retain one (1) copy of
Confidential Information solely for record-keeping purposes and shall not be
required to destroy any off-site computer files created during automatic system
back up which are subsequently stored securely by the receiving Party
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
10.1    Authority and Binding Agreement. Exelixis and BMS each represents and
warrants to the other that (a) it has the corporate power and authority and the
legal right to enter into this Agreement and perform its obligations hereunder;
(b) it has taken all necessary corporate action on its part required to
authorize the execution and delivery of the Agreement and the performance of its
obligations hereunder; and (c) the Agreement has been duly executed and
delivered on behalf of each Party and constitutes a legal, valid and binding
obligation of such Party that is enforceable against it in accordance with its
terms subject to bankruptcy, insolvency, reorganization, arrangement,
winding-up, moratorium, and similar laws of general application affecting the

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enforcement of creditors’ rights generally, and subject to general equitable
principles, including the fact that the availability of equitable remedies, such
as injunctive relief or specific performance, is in the discretion of the court.
10.2    No Conflicts. Exelixis and BMS each represents and warrants that, to the
best of its knowledge, it has not entered, and shall not enter, into any
agreement with any Third Party that is in conflict with the rights granted to
any other Party under this Agreement, and has not taken any action that would in
any way prevent it from granting the rights granted to any other Party under
this Agreement, or that would otherwise materially conflict with or adversely
affect the rights granted to any other Party under this Agreement.
10.3    Litigation. Exelixis and BMS each represents and warrants that, to the
best of its knowledge, it is not aware of any pending or threatened litigation
(and has not received any communication) that alleges that its activities
related to this Agreement have violated, or that by conducting the activities as
contemplated in this Agreement it would violate, any of the intellectual
property rights of any other Person (after giving effect to the license grants
in this Agreement).
10.4    No Adverse Proceedings. Except as otherwise notified to the other Party,
there is not pending or, to the knowledge of such Party, threatened, against
such Party, any claim, suit, action or governmental proceeding that would, if
adversely determined, materially impair the ability of such Party to perform its
obligations under this Agreement.
10.5    Consents. Exelixis and BMS each represents and warrants that, to the
best of its knowledge, all necessary consents, approvals and authorizations of
all regulatory and governmental authorities and other Persons (i) required to be
obtained by such Party in connection with the execution and delivery of this
Agreement have been obtained (or will have been obtained prior to such execution
and delivery) and (ii) required to be obtained by such Party in connection with
the performance of its obligations under this Agreement have been obtained or
will be obtained prior to such performance.
10.6    No Debarment. Each Party hereby certifies to the other that it has not
used, and will not use the services of any person disqualified, debarred,
banned, subject to debarment or convicted of a crime for which a person could be
debarred by the FDA under 21 U.S.C. 335a, as amended (or subject to a similar
sanction of any other Regulatory Authority), in any capacity in connection with
any of the services or work provided under any Combined Therapy Trial and that
this certification may be relied upon in any applications to the FDA or any
other Regulatory Authority. It is understood and agreed that this certification
imposes a continuing obligation upon each Party to notify the other promptly of
any change in the truth of this certification. Upon request by a Party, the
other Party agrees to provide a list of persons used to perform the services or
work provided under any activities conducted for or on behalf of such Party or
any of its Affiliates pursuant to this Agreement who, within the five years
preceding the Effective Date, or subsequent to the Effective Date, were or are
convicted of one of the criminal offenses required by 21 U.S.C. 335a, as
amended, to be listed in any application for approval of an abbreviated
application for drug approval.

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10.7    Compliance with Applicable Law. Exelixis and BMS each represents and
warrants that it shall comply with all Applicable Law of the country or other
jurisdiction, or any court or agency thereof, applicable to the performance of
its activities hereunder or any obligation or transaction hereunder, including
those pertaining to the production and handling of drug products, such as those
set forth by the Regulatory Agencies, as applicable, and the applicable terms of
this Agreement, in the performance of its obligations hereunder.
10.8    Affiliates. Exelixis and BMS each represents and warrants that, to the
extent the intellectual property, Regulatory Documentation or Technology
licensed by it hereunder are Controlled by its Affiliates or a Third Party, it
has the right to use, and has the right to grant (sub)licenses to the other
Party to use, such intellectual property, Regulatory Documentation or Technology
in accordance with the terms of this Agreement.
10.9    Ethical Business Practices. Exelixis and BMS each represents and
warrants that neither it nor its Affiliates will make any payment, either
directly or indirectly, of money or other assets, including the compensation
such Party derives from this Agreement (collectively a “Payment”), to government
or political party officials, officials of International Public Organizations,
candidates for public office, or representatives of other businesses or persons
acting on behalf of any of the foregoing (collectively “Officials”) where such
Payment would constitute violation of any law, including the Foreign Corrupt
Practices Act of 1977, 15 U.S.C. §§ 78dd-1, et seq. In addition, regardless of
legality, neither it nor its Affiliates will make any Payment either directly or
indirectly to Officials if such Payment is for the purpose of improperly
influencing decisions or actions with respect to the subject matter of this
Agreement. All activities will be conducted in compliance with the U.S. False
Claims Act and the U.S. Anti-Kickback Statute.
10.10    Single Agent Compound Safety Issues. Each Party represents and warrants
that, to the best of its knowledge, it is not aware of any material safety or
toxicity issue with respect to its Single Agent Compound(s) that are not
reflected in the investigator’s brochure(s) for its Single Agent Compound(s)
existing as of the Effective Date.
10.11    Accounting. Each Party represents and warrants that all transactions
under the Agreement shall be properly and accurately recorded in all material
respects on its books and records and that each document upon which entries in
such books and records are based is complete and accurate in all material
respects.
10.12    Compliance with Ono Agreements. BMS will use Commercially Reasonable
Efforts to comply with its obligations under the Ono-BMS Agreements (and not to
voluntarily terminate same) to the extent necessary for each Combined Therapy
Trial to be completed in accordance with the terms of this Agreement and for
Exelixis to receive the rights and benefits provided to it under this Agreement.
10.13 Compliance with Ipsen-Exelixis Agreements and Takeda-Exelixis Agreements.
Exelixis will use Commercially Reasonable Efforts to comply with its obligations
under the Ipsen-Exelixis Agreements and the Takeda-Exelixis Agreements (and not
to voluntarily terminate same)

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to the extent necessary for each Combined Therapy Trial to be completed in
accordance with the terms of this Agreement and for BMS to receive the rights
and benefits provided to it under this Agreement.
10.14    DISCLAIMER OF WARRANTY. THE EXPRESS REPRESENTATIONS AND WARRANTIES
STATED IN THIS ARTICLE 10 ARE IN LIEU OF, AND THE PARTIES DO HEREBY DISCLAIM,
ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED OR STATUTORY,
INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR USE, AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS.

ARTICLE 11
INDEMNIFICATION
11.1    BMS Indemnification. BMS hereby agrees to defend, hold harmless and
indemnify (collectively, “Indemnify”) Exelixis, its Affiliates, and their
agents, directors, officers, and employees (the “Exelixis Indemnitees”) from and
against any and all liabilities, expenses and/or losses, including without
limitation reasonable legal expenses and attorneys’ fees (collectively “Losses”)
resulting from Third Party suits, claims, actions and demands (each, a “Third
Party Claim”) to the extent that they arise or result from (a) the negligence or
intentional misconduct of BMS, any BMS Indemnitee or any (sub)licensee of BMS
conducting activities on behalf of BMS under this Agreement; (b) any breach by
BMS of any provision of this Agreement; (c) any injury to a subject in a
Combined Therapy Trial caused solely by the development, use or manufacture of
the BMS Compound(s); (d) any injury to a subject in a Combined Therapy Trial
where it ultimately cannot be or is not determined if such injury is solely the
direct result of the BMS Compound(s) on the one hand or the Exelixis Compound on
the other hand, provided that, in the case of this clause (d), BMS shall only
Indemnify the Exelixis Indemnitees for fifty percent (50%) of any such Loss; or
(e) the use by BMS, its Affiliates, contractors or (sub)licensees of Combined
Therapy Study Data, BMS Study Data, BMS Study Inventions, BMS Study Patent
Rights, Combined Therapy Inventions and Combined Therapy Patent Rights outside
the scope of this Agreement (other than with respect to Third Party Claims that
are covered under Section 6.4)); but excluding, in each case ((a) through (e)),
any such Losses to the extent Exelixis is obligated to Indemnify the BMS
Indemnitees pursuant to Section 11.2.
11.2    Exelixis Indemnification. Exelixis hereby agree to Indemnify BMS, its
Affiliates, and its and their agents, directors, officers, and employees (the
“BMS Indemnitees”) from and against any and all Losses resulting from Third
Party Claims to the extent that they arise or result from (a) the negligence or
intentional misconduct of Exelixis, or any Exelixis Indemnitee or any
(sub)licensee of Exelixis conducting activities on behalf of Exelixis under this
Agreement; (b) any breach by Exelixis of any provision of this Agreement; (c)
any injury to a subject in a Combined Therapy Trial caused solely by the
development, use or manufacture of the Exelixis Compound; (d) any injury to a
subject in a Combined Therapy Trial where it ultimately cannot be or is not

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determined if such injury is solely the direct result of the Exelixis Compound
on the one hand or the BMS Compound(s) on the other hand; provided that, in the
case of this clause (d), Exelixis shall only Indemnify the BMS Indemnitees for
fifty percent (50%) of any such Loss; or (e) the use by Exelixisits Affiliates,
contractors or (sub)licensees of Combined Therapy Study Data, Exelixis Study
Data, Exelixis Study Inventions, Exelixis Study Patent Rights, Combined Therapy
Inventions and Combined Therapy Patent Rights outside the scope of this
Agreement (other than with respect to Third Party Claims that are covered under
Section 6.4)), but excluding, in each case ((a) through (e)), any such Losses to
the extent BMS is obligated to Indemnify the Exelixis Indemnitees pursuant to
Section 11.1.
11.3    Indemnification Procedure. Each Party’s agreement to Indemnify the other
Party is conditioned on the performance of the following by the Party seeking
indemnification: (a) providing written notice to the Indemnifying Party of any
Loss of the types set forth in Section 11.1 and 11.2 within [ * ] after the
Party seeking indemnification has knowledge of such Loss; provided that, any
delay in complying with the requirements of this clause (a) will only limit the
Indemnifying Party’s obligation to the extent of the prejudice caused to the
Indemnifying Party by such delay; (b) permitting the Indemnifying Party to
assume full responsibility to investigate, prepare for and defend against any
such Loss; (c) providing reasonable assistance to the Indemnifying Party, at the
Indemnifying Party’s expense, in the investigation of, preparation for and
defense of any Loss; and (d) not compromising or settling such Loss without the
Indemnifying Party’s written consent, such consent not to be unreasonably
withheld or delayed.
11.4    Separate Defense of Claims. In the event that the Parties cannot agree
as to the application of Sections 11.1 and/or 11.2 to any particular Loss, the
Parties may conduct separate defenses of such Loss. Each Party further reserves
the right to claim indemnity from the other in accordance with Sections 11.1
and/or 11.2 upon resolution of the underlying claim, notwithstanding the
provisions of Section 11.3(b).
11.5    Insurance. Each Party shall maintain commercially reasonable levels of
insurance or other adequate and commercially reasonable forms of protection or
self-insurance to satisfy its indemnification obligations under this Agreement.
Each Party shall provide the other Party with written notice at least [ * ]
prior to the cancellation, non-renewal or material change in such insurance or
self-insurance which would materially adversely affect the rights of the other
Party hereunder. The maintenance of any insurance shall not constitute any limit
or restriction on damages available to a Party under this Agreement.
11.6    LIMITATION OF LIABILITY. NO PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR
INDIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES, INCLUDING BUT NOT
LIMITED TO LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT AND/OR SUCH
PARTY’S PERFORMANCE HEREUNDER, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF
SUCH DAMAGES AND REGARDLESS OF THE CAUSE OF ACTION (WHETHER IN CONTRACT, TORT,
BREACH OF WARRANTY OR OTHERWISE). NOTHING IN THIS SECTION 11.6 IS INTENDED TO
LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF A PARTY

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UNDER SECTIONS 11.1 OR 11.2, OR DAMAGES AVAILABLE FOR BREACHES OF
CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9 OR FOR A PARTY’S GROSS NEGLIGENCE OR
WILLFUL MISCONDUCT.

ARTICLE 12
TERM AND TERMINATION
12.1    Term. This Agreement shall be effective as of the Effective Date and,
unless earlier terminated pursuant to Sections 12.2, 12.3 or 12.4 or any other
termination right expressly stated in this Agreement, shall continue in effect
until completion by all centers or institutions participating in the Combined
Therapy Trials for such Combined Therapy combination, the delivery of all Study
Data, including all completed case report forms, all final analyses and all
final clinical study reports contemplated by the Combined Therapy Trials to both
Parties, and the completion of any then agreed upon Statistical Analysis and
Bioanalysis Plan (the “Term”); provided that if termination language in Section
2.7 applies, then the Term shall expire at such time.
12.2    Termination for Material Breach.
(a)    Notice and Cure Period. If a Party (the “Breaching Party”) is in material
breach, the other Party (the “Non-Breaching Party”) shall have the right to give
the Breaching Party notice specifying the nature of such material breach. The
Breaching Party shall have a period of [ * ] after receipt of such notice to
cure such material breach (the “Cure Period”) in a manner reasonably acceptable
to the Non-Breaching Party. For the avoidance of doubt, this provision is not
intended to restrict in any way a Party’s right to notify the other Party of any
other breach or to demand the cure of any other breach.
(b)    Termination Right. The Non-Breaching Party shall have the right to
terminate this Agreement, upon written notice, in the event that the Breaching
Party has not cured such material breach within the Cure Period, provided,
however, that if such breach is capable of cure but cannot be cured within the
Cure Period, and the Breaching Party commences actions to cure such material
breach within the Cure Period and thereafter diligently continue such actions,
the Breaching Party shall have an additional [ * ] to cure such breach. If a
Party contests such termination pursuant to the dispute resolution procedures
under Section 13.3, such termination shall not be effective until a conclusion
of the dispute resolution procedures in Section 13.3, as applicable, resulting
in a determination that there has been a material breach that was not cured
within the Cure Period (or, if earlier, abandonment of the dispute by such
Party).
12.3    Termination for Bankruptcy. A Party may terminate this Agreement if, at
any time, the other Party shall file, in any court or agency pursuant to any
statute or regulation of any state, country or jurisdiction, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of the other Party or of the other Party’s
assets, or if the other Party proposes a written agreement of composition or
extension of its debts,

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or if the other Party shall be served with an involuntary petition against it,
filed in any insolvency proceeding, and such petition shall not be dismissed or
stayed within [ * ] after the filing thereof, or if the other Party will propose
or be a party to any dissolution or liquidation, or if the other Party shall
make an assignment for the benefit of its creditors.
12.4    Termination due to Material Safety Issue; Clinical Hold.
(a)    BMS or Exelixis shall each have the independent right to immediately
suspend the treatment of subjects in the Combined Therapy Trial and terminate
this Agreement upon written notice if it deems it necessary to protect the
safety, health or welfare of subjects enrolled in any Combined Therapy Trial due
to the existence of a Material Safety Issue. In the event of a termination due
to a Material Safety Issue, prior to the terminating Party providing written
notice, each Party’s safety committee shall, to the extent practicable, meet and
discuss in good faith the safety concerns raised by the terminating Party and
consider in good faith the input, questions and advice of the non-terminating
Party, but should any dispute arise in such discussion, the dispute resolution
processes set forth in Sections 2.7 or 13.3 shall not apply to such dispute and
the terminating Party shall have the right to issue such notice and such
suspension shall take effect without the Parties first following the procedures
set forth in Sections 2.7 or 13.3 and the Agreement shall subsequently terminate
once the Combined Therapy Trial has been wound down pursuant to Section 12.5.
(b)    If a Clinical Hold with respect to either the BMS Compound(s) or the
Exelixis Compound should arise at any time after the Effective Date, the Parties
will meet and discuss the basis for the Clinical Hold, how long the Clinical
Hold is expected to last, and how they might address the issue that caused the
clinical hold. If, after [ * ] of discussions following the Clinical Hold, a
Party reasonably concludes that the issue is not solvable or that unacceptable
and material additional costs/delays have been and/or will continue to be
incurred in the conduct of the Combined Therapy Trial, then such Party may
immediately terminate this Agreement.
12.5    Effect of Termination. Upon expiration or termination of this Agreement,
(a) the licenses granted to each Party to conduct a Combined Therapy Trial in
Sections 3.1 and 3.2 shall terminate, and (b) the Parties shall use reasonable
efforts to wind down activities under this Agreement in a reasonable manner and
avoid incurring any additional expenditures or non-cancellable obligations;
provided that, in the case of termination pursuant to Section 12.4, the
Conducting Party may continue to dose subjects enrolled in any then ongoing
Combined Therapy Trial through completion of the applicable Protocol if dosing
is required by the applicable Regulatory Authority(ies) and/or Applicable
Law(s). Any such wind-down activities will include the return to a Party, or
destruction, of all of such Party’s Compound provided to the other Party and not
consumed in the Combined Therapy Trials. If applicable, upon termination of this
Agreement, the Parties shall remain responsible pursuant to the terms of this
Agreement for any expenses incurred that are associated with terminating any
ongoing clinical trial work and/or result from such ongoing activities under
this Agreement solely to the extent such activities are deemed necessary by the
Conducting Party (after discussion at a meeting of the JDC) based on reasonable
medical judgment to protect the health of subjects participating in any Combined
Therapy Trial.

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12.6    Survival. The following Articles and Sections of this Agreement, all
definitions relating thereto, and any other provisions of this Agreement that by
their nature are intended to survive expiration or termination of this Agreement
shall survive any expiration or termination of this Agreement for any reason:
Section 2.1(b) (fifth sentence), Section 2.1(d) (last two sentences), Section
2.1(e) (last two sentences), Article 6 (“Intellectual Property”), Section 7.1
(“Combined Therapy Trial Expenses”), Section 7.2 (“Invoicing; Payment”), Section
7.4 (“Audit”), Section 8.1 (“Records”), Section 8.2 (“Ownership of Study Data”),
Section 8.3 (“Use of Study Data”), Section 8.4 (“Access to Study Data”), Section
8.5 (“Samples”), Section 8.6, Section 8.7, Article 9 (“Confidentiality”);
Article 10 (“Representations and Warranties”), Article 11 (“Indemnification”),
Section 12.5 (“Effect of Termination”), Section 12.6 (“Survival”), Section 13.1
(“Entire Agreement”), Section 13.2 (“Governing Law”), Section 13.3 (“Dispute
Resolution”), Section 13.4 (“Injunctive Relief”), Section 13.6 (“Notices”),
Section 13.7 (“No Waiver, Modifications”), Section 13.8 (“No Strict
Construction”), Section 13.9 (“Independent Contractor”), Section 13.10
(“Assignment; Licenses”), Section 13.11 (“Headings”), Section 13.13
(“Severability”), Section 13.15 (“No Benefit to Third Parties”), and Section
13.17 (“Construction”).
ARTICLE 13
MISCELLANEOUS
13.1    Entire Agreement. The Parties acknowledge that this Agreement shall
govern all activities of the Parties with respect to the Combined Therapy Trials
from the Effective Date forward. This Agreement, including the Exhibits hereto
and together with the Protocols, the Supplement Agreement (as defined below in
Section 13.16), Quality Agreement, Supply Agreement and Pharmacovigilance
Agreement, sets forth the complete, final and exclusive agreement between the
Parties concerning the subject matter hereof and supersedes all prior agreements
and understandings between the Parties with respect to such subject matter.
There are no covenants, promises, agreements, warranties, representations,
conditions or understandings, either oral or written, between the Parties with
respect to such subject matter other than as are set forth in this Agreement.
All Exhibits attached hereto are incorporated herein as part of this Agreement.
13.2    Governing Law. This Agreement shall be governed and construed in
accordance with the internal laws of the State of New York, USA, excluding any
choice of law rules that may direct the application of the laws of another
jurisdiction.
13.3    Dispute Resolution.
(a)    In the event of any dispute, controversy or claim arising out of,
relating to or in connection with any provision of this Agreement (each a
“Dispute”), other than a JDC Dispute or a Publication Dispute or a dispute as to
whether a Material Safety Issue exists, the Parties shall refer such Dispute
promptly to the Alliance Managers for resolution. If the Alliance Managers are
unable to resolve such Dispute within [ * ] after a matter has been presented to
them, then upon the request of either Party by written notice, the Parties shall
refer such Dispute to the Executive Officers. This Agreement shall remain in
effect during the pendency of any such dispute. In the event that

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no resolution is made by them in good faith negotiations within [ * ] after such
referral to them, such unresolved Dispute shall be referred to the [ * ] of
Exelixis or his or her designee, and the [ * ] of BMS or his or her designee for
attempted resolution by good faith negotiations within [ * ] after such referral
is made. In the event such officers are unable to resolve such Dispute within
such [ * ] period then, if such Dispute constitutes an Arbitration Matter, such
Dispute shall be resolved through arbitration in accordance with the remainder
of this Section 13.3; provided, however, that with respect to any such Dispute
that relates to a matter described in Section 13.4, either Party shall have the
right to seek an injunction or other equitable relief without waiting for the
expiration of such [ * ] negotiation period, and with respect to any JDC Dispute
or Publication Dispute, the specific dispute resolution processes contained in
Sections 2.7 or 9.6(b), as applicable, will apply.
(b)    If a Dispute that constitutes an Arbitration Matter remains unresolved
after escalation to the senior executives as described above, either Party may
refer the matter to arbitration as described herein. Any arbitration under this
Agreement shall be conducted under the auspices of the American Arbitration
Association by a panel of three (3) arbitrators pursuant to that organization’s
Commercial Arbitration Rules then in effect; provided, however, that the Parties
hereby agree that the time schedule for the appointment of arbitrators and the
time schedule for submission of the statement of defense shall follow the
American Arbitration Association Arbitration Rules. The fees and expenses of the
arbitrators shall be borne in equal shares by the Parties. Each Party shall bear
the fees and expenses of its legal representation in the arbitration. The
arbitral tribunal shall not reallocate either the fees and expenses of the
arbitrators or of the Parties’ legal representation. The arbitration shall be
held in New York, New York, USA, which shall be the seat of the arbitration. The
language of the arbitration shall be English.
13.4    Injunctive Relief. Notwithstanding anything herein to the contrary, a
Party may seek an injunction or other injunctive relief from any court of
competent jurisdiction in order to prevent immediate and irreparable injury,
loss or damage on a provisional basis. For the avoidance of doubt, if a Party
(a) discloses Confidential Information of the other Party other than as
permitted under Article 9, (b) uses (in the case of Exelixis) the BMS
Compound(s) or BMS Technology or (in the case of BMS) the Exelixis Compound or
Exelixis Technology in any manner other than as expressly permitted under this
Agreement or (c) otherwise is in material breach of this Agreement and such
material breach could cause immediate harm to the value of the Exelixis Compound
(by BMS) or the BMS Compound(s) (by Exelixis), the other Party shall have the
right to seek an injunction or other equitable relief precluding such Party from
continuing its activities related to the Combined Therapy Trials without waiting
for the conclusion of the dispute resolution procedures under Section 13.3.
13.5    Force Majeure. The Parties shall be excused from the performance of
their obligations under this Agreement (other than the payment of monies owed to
the other Party) to the extent that such performance is prevented by force
majeure and the non-performing Party promptly provides notice of the prevention
to each other Party. Such excuse shall be continued so long as the condition
constituting force majeure continues and the nonperforming Party takes
reasonable efforts to remove the condition. For purposes of this Agreement,
force majeure shall mean acts of

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God, strikes or other concerted acts of workers, civil disturbances, fires,
earthquakes, acts of terrorism, floods, explosions, riots, war, rebellion,
sabotage or failure or default of public utilities or common carriers or similar
conditions beyond the control of the Parties.
13.6    Notices. Any notice required or permitted to be given under this
Agreement shall be in writing, shall specifically refer to this Agreement and
shall be deemed to have been sufficiently given for all purposes if such notice
is timely and is: (a) mailed by first class certified or registered mail,
postage prepaid, return receipt requested, (b) sent by express delivery service,
or (c) personally delivered. Unless otherwise specified in writing, the mailing
addresses of the Parties shall be as described below.
For Exelixis:
Exelixis, Inc.

Attn: EVP and General Counsel
210 East Grand Ave.
South San Francisco, CA 94080

With invoices to:
[ * ]

                    
Or:     Exelixis, Inc.
Attn: AP Group
210 East Grand Ave.
South San Francisco, CA 94080

For BMS:
Bristol-Myers Squibb Company

Route 206 and Province Line Road
Princeton, NJ 08543-4000
Attention: VP, Business Development

With a copy to:     Bristol-Myers Squibb Company
Route 206 and Province Line Road
Princeton, NJ 08543-4000
Attention: VP & Assistant General Counsel, Licensing and Business Development

With invoices to:     Bristol-Myers Squibb Company
Route 206 and Province Line Road
Princeton, NJ 08543-4000
Attention: VP, R&D Finance
    
Any such communication shall be deemed to have been received when delivered. It
is understood and agreed that this Section 13.6 is not intended to govern the
day-to-day business communications

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necessary between the Parties in performing their duties, in due course, under
the terms of this Agreement.
13.7    No Waiver; Modifications. It is agreed that no waiver by a Party hereto
of any breach or default of any of the covenants or agreements herein set forth
shall be deemed a waiver as to any subsequent and/or similar breach or default.
No amendment, modification, release or discharge shall be binding upon the
Parties unless in writing and duly executed by authorized representatives of
both Parties.
13.8    No Strict Construction. This Agreement has been prepared jointly and
shall not be strictly construed against either Party. No presumption as to
construction of this Agreement shall apply against either Party with respect to
any ambiguity in the wording of any provision(s) of this Agreement irrespective
of which Party may be deemed to have authored the ambiguous provision(s).
13.9    Independent Contractor. The Parties are independent contractors of each
other, and the relationship between the Parties shall not constitute a
partnership, joint venture or agency. Neither Party shall be the agent of the
other or have any authority to act for, or on behalf of, the other Party in any
matter.
13.10    Assignment; Licensees.
(a)    Assignment. No Party may assign or transfer this Agreement or any rights
or obligations hereunder without the prior written consent of each other Party,
except that a Party may make such an assignment without each other Party’s
consent (a) to an Affiliate, (b) to a Third Party that merges with, consolidates
with or acquires substantially all of the assets or voting control of the
assigning Party or (c) to a Third Party that acquires all the rights to the
Exelixis Compound, in the case of Exelixis, or the BMS Compound, in the case of
BMS. Any assignment or attempted assignment by any Party in violation of the
terms of this Section 13.10 shall be null and void and of no legal effect.
(b)    Licensees. If a Party grants a third party a license (other than a
license solely to make a Product for a Party and other than any license rights
granted to Ono for the Ono Territory and Ipsen for the Ipsen Territory and
Takeda for the Takeda Territory) to develop and commercialize its Single Agent
Compound(s) on a worldwide basis or in any geographic region and/or for all
purposes or a limited field, (a “Licensee”), such Party will obtain the
Licensee’s agreement to abide by the terms of this Agreement in the same manner
as the licensor Party.
13.11    Headings. The captions to the several Sections and Articles hereof are
not a part of this Agreement, but are included merely for convenience of
reference only and shall not affect its meaning or interpretation.
13.12    Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one (1) and the

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same instrument. This Agreement may be executed by facsimile or electronic
(e.g., .pdf) signatures and such signatures shall be deemed to bind each Party
hereto as if they were original signatures.
13.13    Severability. If any provision of this Agreement is held to be illegal,
invalid or unenforceable under any present or future law, and if the rights or
obligations of a Party under this Agreement will not be materially and adversely
affected thereby, (a) such provision shall be fully severable, (b) this
Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Parties.
13.14    Further Assurance. Each Party shall duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to
be done such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as the other Party
may reasonably request in order to perfect any license, assignment or other
transfer or any properties or rights under, or pursuant, to this Agreement.
13.15    No Benefit to Third Parties. The representations, warranties and
agreements set forth in this Agreement are for the sole benefit of the Parties
and their successors and permitted assigns, and they shall not be construed as
conferring any rights on any other parties.
13.16    Supplement Agreement. BMS, Exelixis and Ipsen shall execute the
Supplement to the Clinical Trial Collaboration Agreement (the “Supplement
Agreement”) concurrently with the execution of this Agreement by BMS and
Exelixis, and if the Supplement Agreement is not so executed concurrently with
this Agreement, this Agreement shall be null and void and of no force or effect.
13.17    Construction.
(a)    General. Except as otherwise explicitly specified to the contrary, (a)
references to a Section, Article or Exhibit means a Section or Article of, or
Exhibit to, this Agreement and all subsections thereof, unless another agreement
is specified; (b) references to a particular statute or regulation include all
rules and regulations promulgated thereunder and any successor statute, rules or
regulations then in effect, in each case including the then-current amendments
thereto; (c) words in the singular or plural form include the plural and
singular form, respectively; (d) the terms “including,” “include(s),” “such as,”
and “for example” used in this Agreement mean including the generality of any
description preceding such term and will be deemed to be followed by “without
limitation”; and (e) the words “hereof,” “herein,” “hereunder,” “hereby” and
derivative or similar words refer to this Agreement. No presumption as to
construction of this Agreement shall apply against either Party with respect to
any ambiguity in the wording of any provision(s) of

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this Agreement irrespective of which Party may be deemed to have authored the
ambiguous provision(s).
(b)    No Response. Where a provision of this Agreement provides for a Party to
respond within a designated period following written notice from the other Party
(e.g., Sections 5.1(a)(vi) and 5.1(b)(v), and if such Party fails to respond,
then the failure to respond shall not be deemed to create or imply: (i) that the
non-responding Party agrees or disagrees with the proposed action to be taken by
the other Party, (ii) any amendment, change or waiver of the terms of this
Agreement, or (iii) any consent that an action proposed to be taken may be taken
if it conflicts with the terms of this Agreement and/or waiver of any rights it
may have to seek remedies at law or in equity for breach of this Agreement as a
result of the action taken.

Signature page follows

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

Exelixis, Inc.
Bristol-Myers Squibb Company
By: /s/ Gisela M. Schwab
By: /s/ Fouad Namouni
Name: Gisela M. Schwab, M.D.
Name: Fouad Namouni, M.D.
Title: President, Product Development and Medial Affairs, CMO
Title: Head of Oncology Development

    

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Exhibit Index
Attached:
Exhibit A:    Combined Therapy Studies Expected to be Conducted (as of Effective
Date)
Exhibit B:    Clinical Protocol Synopsis for Initial Trial for Renal Cell
Carcinoma
Exhibit C:    Clinical Protocol Synopsis for Initial Trial for Hepatocellular
Carcinoma
Exhibit D:    Press Release

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Exhibit Index
Attached:
Exhibit A:    Combined Therapy Studies Expected to be Conducted (as of Effective
Date)
Exhibit B:    Clinical Protocol Synopsis for Initial Trial for Renal Cell
Carcinoma
Exhibit C:    Clinical Protocol Synopsis for Initial Trial for Hepatocellular
Carcinoma
Exhibit D:    Press Release

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EXHIBIT A
Combined Therapy Studies Expected to be Conducted (as of Effective Date)
[ * ]

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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EXHIBIT B
CLINICAL PROTOCOL SYNOPSIS FOR INITIAL TRIAL FOR RENAL CELL CARCINOMA
{Deleted content comprises approximately 5 pages}

[ * ]

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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EXHIBIT C
CLINICAL PROTOCOL SYNOPSIS OF INITIAL TRIAL FOR HEPATOCELLUALR CARCINOMA
{Redacted content comprises approximately 2 pages}
[ * ]

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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PRESS RELEASE

exhibitexelixislogo.jpg [exhibitexelixislogo.jpg]    exhibit102bmslogoa01.jpg
[exhibit102bmslogoa01.jpg]

EXELIXIS AND BRISTOL-MYERS SQUIBB ENTER CLINICAL COLLABORATION FOR LATE-STAGE
COMBINATION TRIAL IN FIRST-LINE RENAL CELL CARCINOMA

Companies intend to initiate pivotal trial evaluating CABOMETYX™ (cabozantinib)
with Opdivo® (nivolumab) alone or in combination with Yervoy® (ipilimumab) in
first-line renal cell carcinoma
Planning additional studies in bladder cancer and hepatocellular carcinoma

SOUTH SAN FRANCISCO, Calif. and NEW YORK -- DATE, 2017 -- Exelixis, Inc.
(Nasdaq:EXEL) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the
companies have entered into a clinical development collaboration to evaluate
CABOMETYX™ (cabozantinib), Exelixis’ small molecule inhibitor of receptor
tyrosine kinases, with Opdivo® (nivolumab), Bristol-Myers Squibb’s PD-1 immune
checkpoint inhibitor, either alone or in combination with Yervoy® (ipilimumab).
The clinical development program, which will be co-funded by the companies, is
expected to include a phase 3 pivotal trial in first-line renal cell carcinoma,
with additional trials planned in bladder cancer, hepatocellular carcinoma
(HCC), and potentially other tumor types.

“The safety and efficacy data from the phase 1 clinical trial evaluating
CABOMETYX in combination with Opdivo are consistent with the preclinical
scientific rationale for combining these two therapeutic modalities,” said
Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.
“This clinical development collaboration will provide the resources and
collaborative framework to fully evaluate the potential for this combination,
with and without Yervoy, in both late-stage pivotal and exploratory trials in a
variety of forms of cancer. We look forward to working with Bristol-Myers Squibb
to further understand the role these combination therapies may play in helping
patients on a global basis.”

“Combining our Immuno-Oncology portfolio with promising agents which target
different and complementary pathways is a key component of our strategy to
improve treatment outcomes for patients,” said Fouad Namouni, M.D., Head of
Development, Oncology, Bristol-Myers Squibb. “We look forward to working with
Exelixis, bringing together our knowledge and experience in oncology, to
evaluate the potential clinical value of combining these therapies to treat
multiple tumors.”

The clinical development collaboration builds upon previously published
preclinical and clinical data that provide a scientific rationale for combining
CABOMETYX with immunotherapies, including phase 1 data of CABOMETYX in
combination with Opdivo in patients with previously treated genitourinary tumors
that were presented at the European Society for Medical Oncology (ESMO) 2016
Congress.

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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Updated results from this part of the study as well as results from a second
part evaluating the combination of CABOMETYX, Opdivo and Yervoy were presented
at the American Society of Clinical Oncology 2017 Genitourinary Cancers
Symposium during the poster discussion session (Abstract #293) on February 17 at
the 2017 Genitourinary Cancers Symposium, which is being held in Orlando,
Florida, February 16 – 18, 2017.

CABOMETYX and Opdivo have both received approval in the United States and
European Union for specific uses in previously treated renal cell carcinoma, and
both compounds are the subject of ongoing, global phase 3 pivotal trials in
hepatocellular carcinoma. Opdivo is approved in the United States for previously
treated bladder cancer.

About Exelixis’ Collaboration with Ipsen

On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive
licensing agreement for the commercialization and further development of
cabozantinib indications outside of the United States, Canada and Japan. On
December 21, 2016, this agreement was amended to include commercialization
rights for Ipsen in Canada. Ipsen, Exelixis’ global partner for cabozantinib in
all geographies outside the United States and Japan, has opted in to participate
in the phase 3 pivotal trial in first-line renal cell carcinoma and will have
access to the results to support potential future regulatory submissions. They
may also participate in future studies at their choosing.

About Exelixis’ Collaboration with Takeda

On January 30, 2017, Exelixis and Takeda jointly announced an exclusive
licensing agreement for the commercialization and further development of
cabozantinib indications in Japan. Takeda may also participate in these and
future studies and have access to the results to support potential future
regulatory submissions in their territories, if they opt into their funding
obligations under the respective collaboration agreements.

Exelixis holds the exclusive rights to develop and commercialize cabozantinib in
the United States.

About CABOMETYX™ (cabozantinib)

CABOMETYX is the tablet formulation of cabozantinib. Its targets include MET,
AXL and VEGFR-1, -2 and -3. In preclinical models, cabozantinib has been shown
to inhibit the activity of these receptors, which are involved in normal
cellular function and pathologic processes such as tumor angiogenesis,
invasiveness, metastasis and drug resistance.

CABOMETYX is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is
60 mg orally, once daily.

On April 25, 2016, the FDA approved CABOMETYX tablets for the treatment of
patients with advanced renal cell carcinoma who have received prior
anti-angiogenic therapy. On September 9, 2016, the European Commission approved
CABOMETYX tablets for the treatment of advanced renal cell carcinoma in adults
who have received prior vascular endothelial growth factor (VEGF)-targeted
therapy in the European Union, Norway and Iceland.

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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About the Opdivo Clinical Development Program
Bristol-Myers Squibb’s global development program founded on scientific
expertise in the field of Immuno-Oncology includes a broad range of clinical
trials studying Opdivo, across all phases, including Phase 3, in a variety of
tumor types. To date, the Opdivo clinical development program has enrolled more
than 25,000 patients.
About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co.,
Bristol-Myers Squibb expanded its territorial rights to develop and
commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono
had retained all rights to the compound at the time. On July 2014, Ono and
Bristol-Myers Squibb further expanded the companies’ strategic collaboration
agreement to jointly develop and commercialize multiple immunotherapies – as
single agents and combination regimens – for patients with cancer in Japan,
South Korea and Taiwan.
CABOMETYX U.S. Important Safety Information
Hemorrhage: Severe hemorrhage occurred with CABOMETYX. The incidence of Grade ≥3
hemorrhagic events was 2.1% in CABOMETYX-treated patients and 1.6% in
everolimus-treated patients. Fatal hemorrhages also occurred in the cabozantinib
clinical program. Do not administer CABOMETYX to patients that have or are at
risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: Fistulas were reported in 1.2%
(including 0.6% anal fistula) of CABOMETYX-treated patients and 0% of
everolimus-treated patients. GI perforations were reported in 0.9% of
CABOMETYX-treated patients and 0.6% of everolimus-treated patients. Fatal
perforations occurred in the cabozantinib clinical program. Monitor patients for
symptoms of fistulas and perforations. Discontinue CABOMETYX in patients who
experience a fistula that cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of
thrombotic events. Venous thromboembolism was reported in 7.3% of
CABOMETYX-treated patients and 2.5% of everolimus-treated patients. Pulmonary
embolism occurred in 3.9% of CABOMETYX-treated patients and 0.3% of
everolimus-treated patients. Events of arterial thromboembolism were reported in
0.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients.
Fatal thrombotic events occurred in the cabozantinib clinical program.
Discontinue CABOMETYX in patients who develop an acute myocardial infarction or
any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an
increased incidence of treatment-emergent hypertension. Hypertension was
reported in 37% (15% Grade ≥3) of CABOMETYX-treated patients and 7.1% (3.1%
Grade ≥3) of everolimus-treated patients. Monitor blood pressure prior to
initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for
hypertension that is not adequately controlled with medical management; when
controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe
hypertension that cannot be controlled with anti-hypertensive therapy.
Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe
hypertension despite optimal medical management.
Diarrhea: Diarrhea occurred in 74% of patients treated with CABOMETYX and in 28%
of patients treated with everolimus. Grade 3 diarrhea occurred in 11% of
CABOMETYX-treated patients and in 2% of everolimus-treated patients. Withhold
CABOMETYX in patients who develop intolerable Grade 2 diarrhea

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal
treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Dose modification due to diarrhea occurred in 26% of patients.
Palmar-Plantar Erythrodysesthesia Syndrome (PPES): Palmar-plantar
erythrodysesthesia syndrome (PPES) occurred in 42% of patients treated with
CABOMETYX and in 6% of patients treated with everolimus. Grade 3 PPES occurred
in 8.2% of CABOMETYX-treated patients and in <1% of everolimus-treated patients.
Withhold CABOMETYX in patients who develop intolerable Grade 2 PPES or Grade 3
PPES until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose
modification due to PPES occurred in 16% of patients.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of
subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred
in the cabozantinib clinical program. Perform an evaluation for RPLS in any
patient presenting with seizures, headache, visual disturbances, confusion, or
altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity: CABOMETYX can cause fetal harm when administered to a
pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception during
treatment with CABOMETYX and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are:
diarrhea, fatigue, nausea, decreased appetite, PPES, hypertension, vomiting,
weight decreased, and constipation.
Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce the dosage of
CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided.
Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers
cannot be avoided.
Lactation: Advise a lactating woman not to breastfeed during treatment with
CABOMETYX and for 4 months after the final dose.
Reproductive Potential: Contraception―Advise females of reproductive potential
to use effective contraception during treatment with CABOMETYX and for 4 months
after the final dose. Infertility ―CABOMETYX may impair fertility in females and
males of reproductive potential.
Hepatic Impairment: Reduce the CABOMETYX dose in patients with mild (Child-Pugh
score [C-P] A) or moderate (C-P B) hepatic impairment. CABOMETYX is not
recommended for use in patients with severe hepatic impairment.
Please see full Prescribing Information at
https://cabometyx.com/downloads/cabometyxuspi.pdf.

OPDIVO AND YERVOY INDICATIONS & IMPORTANT SAFETY INFORMATION
INDICATIONS
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients
with BRAF V600 mutation-positive unresectable or metastatic melanoma. This
indication is approved under accelerated approval based on progression-free
survival. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients
with BRAF V600 wild-type unresectable or metastatic melanoma.

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for
the treatment of patients with unresectable or metastatic melanoma. This
indication is approved under accelerated approval based on progression-free
survival. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic
non-small cell lung cancer (NSCLC) with progression on or after platinum-based
chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have
disease progression on FDA-approved therapy for these aberrations prior to
receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced
renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with classical
Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous
hematopoietic stem cell transplantation (HSCT) and post-transplantation
brentuximab vedotin. This indication is approved under accelerated approval
based on overall response rate. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in confirmatory
trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or
metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease
progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who have disease progression during
or following platinum-containing chemotherapy or have disease progression within
12 months of neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. This indication is approved under accelerated approval based on
tumor response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of clinical
benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse reactions. These
immune-mediated reactions may involve any organ system; however, the most common
severe immune-mediated adverse reactions are enterocolitis, hepatitis,
dermatitis (including toxic epidermal necrolysis), neuropathy, and
endocrinopathy. The majority of these immune-mediated reactions initially
manifested during treatment; however, a minority occurred weeks to months after
discontinuation of YERVOY.
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy,
and endocrinopathy and evaluate clinical chemistries including liver function
tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function
tests at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid
therapy for severe immune-mediated reactions.
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported.
Monitor patients for signs with radiographic imaging and for symptoms of
pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis.
Permanently discontinue for Grade 3 or 4 and withhold until resolution for

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of
immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred
in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY,
immune-mediated pneumonitis occurred in 6% (25/407) of patients.
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease,
occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated
pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1)
and Grade 2 (n=8).
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients for signs and
symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days
duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and
permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of
OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2
and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients
receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994)
of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis
occurred in 26% (107/407) of patients including three fatal cases.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or
fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs;
Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across
all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal
perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were
hospitalized for severe enterocolitis.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver
tests prior to and periodically during treatment. Administer corticosteroids for
Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently
discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving
OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of
patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis
occurred in 13% (51/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or
fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin
elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal
hepatic failure in 0.2% and hospitalization in 0.4%.
Immune-Mediated Neuropathies
In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré
syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were
reported.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal
insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus.
Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of
adrenal insufficiency, thyroid function prior to and periodically during
treatment, and hyperglycemia. Administer hormone replacement as clinically
indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for
Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer
corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and
permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer
hormone-replacement therapy for hypothyroidism. Initiate medical management for
control of

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for
Grade 4 hyperglycemia.
In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6%
(12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis
occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy,
adrenal insufficiency occurred in 1% (20/1994) of patients. In patients
receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of
patients. In patients receiving OPDIVO monotherapy, hypothyroidism or
thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients.
Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO
monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or
thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients.
Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with
YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9%
(17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes
occurred in 1.5% (6/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening
immune-mediated endocrinopathies (requiring hospitalization, urgent medical
intervention, or interfering with activities of daily living; Grade 3-4)
occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had
additional concomitant endocrinopathies such as adrenal insufficiency,
hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for
severe endocrinopathies.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum
creatinine prior to and periodically during treatment. Administer
corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for
Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine.
In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal
dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO
with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2%
(9/407) of patients.
Immune-Mediated Skin Adverse Reactions and Dermatitis
OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS)
and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer
corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently
discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold
OPDIVO and refer the patient for specialized care for assessment and treatment;
if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy,
immune-mediated rash occurred in 9% (171/1994) of patients. In patients
receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of
patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or
fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal
necrolysis, or rash complicated by full thickness dermal ulceration, or
necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13
(2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal
necrolysis. 1 additional patient required hospitalization for severe dermatitis.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with
neurologic symptoms may include, but not be limited to, consultation with a
neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with
new-onset moderate to severe neurologic signs or symptoms and evaluate to rule
out other causes. If other etiologies are ruled out, administer corticosteroids
and

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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permanently discontinue OPDIVO for immune-mediated encephalitis. In patients
receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of
patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of
exposure despite discontinuation of OPDIVO and administration of
corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with
YERVOY (0.2%) after 1.7 months of exposure.
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently discontinue or withhold
treatment, administer high-dose corticosteroids, and, if appropriate, initiate
hormone-replacement therapy. Across clinical trials of OPDIVO the following
clinically significant immune-mediated adverse reactions occurred in <1.0% of
patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens
nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy,
Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response
syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing
lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis,
motor dysfunction, vasculitis, and myasthenic syndrome.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of
patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4
infusion reactions. Interrupt or slow the rate of infusion in patients with
Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related
reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO
with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.
Complications of Allogeneic HSCT after OPDIVO
Complications, including fatal events, occurred in patients who received
allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from
Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO
(15 with reduced-intensity conditioning, 2 with myeloablative conditioning).
Thirty-five percent (6/17) of patients died from complications of allogeneic
HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory
GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients.
Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring
febrile syndrome, without an identified infectious cause, was reported in 35%
(n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1)
lymphocytic encephalitis without an identified infectious cause, and Grade 3
(n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD)
occurred in one patient, who received reduced-intensity conditioned allogeneic
HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after
reduced-intensity conditioned allogeneic HSCT have also been reported in
patients with lymphoma who received a PD-1 receptor blocking antibody before
transplantation. Cases of fatal hyperacute GVHD have also been reported. These
complications may occur despite intervening therapy between PD-1 blockade and
allogeneic HSCT.
Follow patients closely for early evidence of transplant-related complications
such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring
febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and
intervene promptly.
Embryo-Fetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk to
a fetus. Advise females of reproductive potential to use effective contraception
during treatment with an OPDIVO- or YERVOY- containing regimen and for at least
5 months after the last dose of OPDIVO.

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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Lactation
It is not known whether OPDIVO or YERVOY is present in human milk. Because many
drugs, including antibodies, are excreted in human milk and because of the
potential for serious adverse reactions in nursing infants from an
OPDIVO-containing regimen, advise women to discontinue breastfeeding during
treatment. Advise women to discontinue nursing during treatment with YERVOY and
for 3 months following the final dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of patients
receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of
patients receiving OPDIVO . The most frequent Grade 3 and 4 adverse drug
reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal
pain, hyponatremia, increased aspartate aminotransferase, and increased lipase.
In Checkmate 066, serious adverse reactions occurred in 36% of patients
receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of
patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions
reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase
increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions
(73% and 37%), adverse reactions leading to permanent discontinuation (43% and
14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72%
and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313)
relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse
reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were
diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In
Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients
receiving OPDIVO (n=418). The most frequent serious adverse reactions reported
in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism,
dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In
Checkmate 025, serious adverse reactions occurred in 47% of patients receiving
OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of
patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and
hypercalcemia. In Checkmate 205 and 039, among all patients (safety population
[n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing
delays (23%) occurred. The most frequent serious adverse reactions reported in
≥1% of patients were infusion-related reaction, pneumonia, pleural effusion,
pyrexia, rash and pneumonitis. Ten patients died from causes other than disease
progression, including 6 who died from complications of allogeneic HSCT. Serious
adverse reactions occurred in 21% of patients in the safety population (n=263)
and 27% of patients in the subset of patients evaluated for efficacy (efficacy
population [n=95]). In Checkmate 141, serious adverse reactions occurred in 49%
of patients receiving OPDIVO. The most frequent serious adverse reactions
reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea,
respiratory failure, respiratory tract infections, and sepsis. In Checkmate 275,
serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270).
The most frequent serious adverse reactions reported in at least 2% of patients
receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine
obstruction, and general physical health deterioration.
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO
(n=268) was rash (21%). In Checkmate 066, the most common adverse reactions
(≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs
39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs
12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO
plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea
(40%),

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse
reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea
(31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse
reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue,
musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025,
the most common adverse reactions (≥20%) reported in patients receiving OPDIVO
(n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34%
vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea
(25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back
pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, among
all patients (safety population [n=263]) and the subset of patients in the
efficacy population (n=95), respectively, the most common adverse reactions
(≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and
48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In
the subset of patients in the efficacy population (n=95), the most common
adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus
(25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%). In
Checkmate 141, the most common adverse reactions (≥10%) in patients receiving
OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice.
In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients
receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea
(22%), and decreased appetite (22%).
In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions
(≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea
(32%), pruritus (31%), rash (29%), and colitis (8%).
Checkmate Trials and Patient Populations
Checkmate 067 - advanced melanoma alone or in combination with YERVOY; Checkmate
037 and 066 - advanced melanoma; Checkmate 017 - squamous non-small cell lung
cancer (NSCLC); Checkmate 057 - non-squamous NSCLC; Checkmate 025 - renal cell
carcinoma; Checkmate 205/039 - classical Hodgkin lymphoma; Checkmate 141 –
squamous cell carcinoma of the head and neck; Checkmate 275 - urothelial
carcinoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY,
including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

About Exelixis

Exelixis, Inc. (Nasdaq:EXEL) is a biopharmaceutical company committed to the
discovery, development and commercialization of new medicines with the potential
to improve care and outcomes for people with cancer. Since its founding in 1994,
three products discovered at Exelixis have progressed through clinical
development to receive regulatory approval. Currently, Exelixis is focused on
advancing cabozantinib, an inhibitor of multiple tyrosine kinases including MET,
AXL and VEGF receptors, which has shown clinical anti-tumor activity in more
than 20 forms of cancer and is the subject of a broad clinical development
program. Two separate formulations of cabozantinib have received regulatory
approval to treat certain forms of kidney and thyroid cancer and are marketed
for those purposes as CABOMETYX™ tablets (U.S. and EU) and COMETRIQ® capsules
(U.S. and EU), respectively. Another Exelixis-discovered compound, COTELLIC®
(cobimetinib), a selective inhibitor of MEK, has been approved in major
territories including the United States and European Union, and is being
evaluated for further potential indications by Roche and Genentech (a member of
the Roche Group) under a collaboration with

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

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Exelixis. For more information on Exelixis, please visit www.exelixis.com or
follow @ExelixisInc on Twitter.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to
discover, develop and deliver innovative medicines that help patients prevail
over serious diseases. For more information about Bristol-Myers Squibb, visit us
at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements, including, without
limitation, statements related to: the expectation that the clinical development
program will include a phase 3 pivotal trial in first-line renal cell carcinoma,
with additional trials planned in bladder cancer, HCC and potentially other
tumor types; the clinical potential for the combination of CABOMETYX and Opdivo,
with and without Yervoy, in both late-stage pivotal and exploratory trials in a
variety of forms of cancer; Exelixis’ plan to work with Bristol-Myers Squibb to
further understand the role these combination therapies may play in helping
patients on a global basis; the anticipated timing for updated results from the
phase 1 trial of CABOMETYX in combination with Opdivo in patients with
previously treated genitourinary tumors; Ipsen’s rights to access the results
from the phase 3 pivotal trial in first-line renal cell cancer to support
potential regulatory submissions; the potential for Ipsen and Takeda to
participate in future studies under the clinical collaboration; Exelixis'
commitment to the discovery, development and commercialization of new medicines
with the potential to improve care and outcomes for people with cancer;
Exelixis’ focus on advancing cabozantinib; and the continued development of
cobimetinib. Words such as “expected,” “planned,” “potential,” “look forward,”
“may,” “will,” “committed,” “focused,” or other similar expressions identify
forward-looking statements, but the absence of these words does not necessarily
mean that a statement is not forward-looking. In addition, any statements that
refer to expectations, projections or other characterizations of future events
or circumstances are forward-looking statements. These forward-looking
statements are based upon Exelixis’ current plans, assumptions, beliefs,
expectations, estimates and projections. Forward-looking statements involve
risks and uncertainties. Actual results and the timing of events could differ
materially from those anticipated in the forward-looking statements as a result
of these risks and uncertainties, which include, without limitation: Exelixis’
ability and the ability of its collaborators to conduct clinical trials of
CABOMETYX in combination with Opdivo and Yervoy sufficient to achieve a positive
completion; risks related to the potential failure of the combination of these
compounds to demonstrate safety and efficacy in clinical testing; Exelixis’
dependence on its collaboration partners, including, the level of their
investment in the resources necessary to successfully develop CABOMETYX in
combination with Opdivo and Yervoy; the complexities and challenges associated
with regulatory review and approval processes; the availability of data at the
referenced time; the degree of market acceptance of CABOMETYX and the
availability of coverage and reimbursement for CABOMETYX; the risk that
unanticipated developments could adversely affect the commercialization of
CABOMETYX; Exelixis’ dependence on third-party vendors; Exelixis’ ability to
protect the company’s intellectual property rights; market competition; changes
in economic and business conditions, and other factors discussed under the
caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on November 3, 2016, and in Exelixis’
future filings with the SEC. The forward-looking statements made in this press
release speak only as of the date of this press release. Exelixis expressly
disclaims any duty, obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect any
change in Exelixis’ expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.

Bristol-Myers Squibb Company Forward-Looking Statements
This press release contains “forward-looking statements” as that term is defined
in the Private Securities Litigation Reform Act of 1995 regarding the research,
development and commercialization of pharmaceutical products. Such
forward-looking statements are based on current expectations and involve
inherent risks and uncertainties, including factors that could delay, divert or
change any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement can be
guaranteed. Among other risks, there can be no guarantee that the compound
discussed in this release, either alone or in combination with Opdivo or Yervey,
will be successfully developed or approved for any of the indications described
in this release. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Bristol-Myers
Squibb's business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year
ended December 31, 2015 in our Quarterly Reports on Form 10-Q and our Current
Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events or otherwise.

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
    

--------------------------------------------------------------------------------

    

Exelixis Contacts:    

Investors:
Susan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis, Inc.
(650) 837-8194, shubbard@exelixis.com
Media:
Hal Mackins
For Exelixis, Inc.
(415) 994-0040, hal@torchcomllc.com

Bristol-Myers Squibb Contacts:

Media:
Ken Dominski, 609-252-5251, ken.dominski@bms.com
Lisa McCormick Lavery, 609-252-7602, lisa.mccormicklavery@bms.com

Investors:
Tim Power, 609-252-7509, timothy.power@bms.com
Bill Szablewski, 609-252-5894, william.szablewski@bms.com

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.