[ * ] = 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.

EXECUTION VERSION

CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
by and between
Merck Sharp & Dohme B.V.,
and
Array BioPharma, Inc.
Dated: May 4, 2017

1

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[ * ] = 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.

EXECUTION VERSION

TABLE OF CONTENTS
Page
1.Definitions    1
2.Scope of the Agreement.    8
2.1.Generally    8
2.2.Manufacturing Delay.    8
2.3.Compound Commitments    8
2.4.Delegation of Obligations    9
2.5.Compounds    9
3.Conduct of the Study    9
3.1.Sponsor    9
3.2.Performance    9
3.3.Debarred Personnel; Exclusion Lists    9
3.4.Regulatory Matters    10
3.5.Documentation    10
3.6.Copies    10
3.7.Samples    11
3.8.Ownership and Use of Clinical Data    11
3.9.Regulatory Submission    13
3.10.Joint Development Committee    13
3.11.Interim and Final Study Report    14
3.12.Relationship    14
3.13.Licensing    14
3.14.Subsequent Study    15
4.Protocol and Certain Other Documents    15
4.1.Protocol    15
4.2.Informed Consent    16
4.3.Financial Disclosure    16
5.Adverse Event Reporting    17
5.1.Pharmacovigilance Agreement    17
5.2.Transmission of SAEs    18
6.Term and Termination.    18
6.1.Term    18
6.2.Company Termination Right for Safety    18
6.3.Material Breach    18

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[ * ] = 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.

EXECUTION VERSION

6.4.Mutual Termination Right for Patient Safety    18
6.5.Mutual Termination Right Due to Regulatory Action; Other Reasons    19
6.6.Return of Company Compound    19
6.7.Anti-Corruption    19
6.8.Survival    19
6.9.No Prejudice    19
6.10.Confidential Information    19
6.11.Manufacturing Costs    20
7.Costs of Study    20
8.Supply and Use of the Compounds    20
8.1.Supply of the Compounds    20
8.2.Clinical Quality Agreement    21
8.3.Minimum Shelf Life Requirements    21
8.4.Provision of Compounds    21
8.5.Labeling and Packaging; Use, Handling and Storage    22
8.6.Product Specifications    22
8.7.Changes to Manufacturing    22
8.8.Product Testing; Noncompliance    22
8.9.Investigations    24
8.10.Shortage; Allocation    24
8.11.Records; Audit Rights    24
8.12.Quality    24
8.13.Quality Control    24
8.14.Audits and Inspections    25
8.15.Recalls    25
8.16.VAT    25
9.Confidentiality    25
9.1.Confidential Information.    25
9.2.Inventions    26
9.3.Personal Identifiable Data    26
10.Intellectual Property    26
10.1.Joint Ownership and Prosecution    26
10.2.Inventions Owned by Company    29
10.3.Inventions Owned by Merck    29
10.4.Separation of Patent Rights.    30

ii

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[ * ] = 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.

EXECUTION VERSION

10.5.Mutual Freedom to Operate for Combination Inventions    30
11.Reprints; Rights of Cross-Reference    31
12.Publications; Press Releases    31
12.1.Clinical Trial Registry    31
12.2.Publication    31
12.3.Press Releases..    32
13.Representations and Warranties; Disclaimers    32
13.1.Due Authorization    32
13.2.Compounds    32
13.3.Results    32
13.4.Anti-Corruption    33
13.5.Disclaimer    35
14.Insurance; Indemnification; Limitation of Liability    35
14.1.Insurance    35
14.2.Indemnification    35
14.3.Limitation of Liability    36
15.Use of Name    37
16.Force Majeure    37
17.Entire Agreement; Amendment; Waiver    37
18.Assignment and Affiliates    37
19.Invalid Provision    38
20.No Additional Obligations    38
21.Governing Law; Dispute Resolution    38
22.Notices    38
23.Relationship of the Parties    39
24.Counterparts and Due Execution    39
25.Construction    39

Appendices
Appendix A – Protocol Synopsis
Appendix B – Supply of Compound
 
Schedules
Schedule 1 – Data Sharing and Sample Testing

CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (this “Agreement”), made
as of May 4, 2017 (the “Effective Date”), is by and between Merck Sharp & Dohme
B.V., having a place of business at Waarderweg 39, 2031 BN Haarlem, Netherlands
(“Merck”), and Array Biopharma, Inc., having a place of business at 3200 Walnut
Street Boulder, CO 80301 (“Company”). Merck and Company are each referred to
herein individually as “Party” and collectively as “Parties”.
RECITALS
A.Merck holds intellectual property rights with respect to the Merck Compound
(as defined below).
B.Company is developing the Company Compound (as defined below) for the
treatment of certain tumor types.
C.Merck is developing the Merck Compound for the treatment of certain tumor
types.
D.Merck desires to sponsor a clinical trial in which the Company Compound and
the Merck Compound would be dosed concurrently or sequentially.
E.Merck and Company, consistent with the terms of this Agreement, desire to
collaborate as more fully described herein, including by providing the Merck
Compound and the Company Compound for the Study (as defined below).
NOW, THEREFORE, in consideration of the premises and of the following mutual
promises, covenants and conditions, the Parties, intending to be legally bound,
mutually agree as follows:

1.Definitions.

For all purposes of this Agreement, the capitalized terms defined in this
Article 1 and throughout this Agreement shall have the meanings herein
specified.
1.1.    “Affiliate” means, with respect to either Party, a firm, corporation or
other entity that directly or indirectly owns or controls said Party, or is
owned or controlled by said Party, or is under common ownership or control with
said Party. The word “control” (including, with the correlative meaning,
“controlled by”) as used in this definition means (a) the direct or indirect
ownership of fifty percent (50%) or more of the outstanding voting securities of
a legal entity, or (b) possession, directly or indirectly, of the power to
direct the management or policies of a legal entity, whether through the
ownership of voting securities, contract rights, voting rights, corporate
governance or otherwise.
1.2.    “Agreement” means this agreement, as amended by the Parties from time to
time, and as set forth in the preamble.
1.3.    “Alliance Manager” has the meaning set forth in Section 3.10.
1.4.    “Applicable Law” means all federal, state, local, national and regional
statutes, laws, rules, regulations and directives applicable to a particular
activity hereunder, including performance of clinical trials, and the processing
and protection of personal and medical data, that may be in effect from time to
time, including the U.S. Food, Drug, and Cosmetic Act and the regulations
promulgated thereunder by the United States Food and Drug Administration
(“FDA”), and those promulgated by national regulatory authorities, the European
Medicines Agency (“EMA”) and any successor agency to the FDA or EMA or any
agency or authority performing some or all of the functions of the FDA or EMA in
any jurisdiction outside the United States or the European Union (each a
“Regulatory Authority” and collectively, “Regulatory Authorities”), and
including cGMP and GCP (each as defined below); all data protection requirements
such as those specified in the EU Data Protection Directive and the regulations
issued under the United States Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”); export control and economic sanctions regulations which
prohibit the shipment of United States-origin products and technology to certain
restricted countries, entities and individuals; anti-bribery and anti-corruption
laws pertaining to interactions with government agents, officials and
representatives; laws and regulations governing payments to healthcare
providers; and any United States or other country’s or jurisdiction’s successor
or replacement statutes, laws, rules, regulations and directives relating to the
foregoing.
1.5.    “Business Day” means any day other than a Saturday, Sunday, or a day on
which commercial banks located in Boulder, Colorado or New York, New York are
authorized or required by law to be closed.
1.6.    “cGMP” means the current Good Manufacturing Practices regulations,
rules, or binding guidance issued by EMA, FDA and other applicable Regulatory
Authorities that may be in effect from time to time and are applicable to the
Manufacture of the Compounds.
1.7.    “Clinical Data” means all data (including raw data) and results
collected or generated by or on behalf of either Party or at either Party’s
direction, or by or on behalf of the Parties together or at their direction, in
the course of performance of the Study by or on behalf of each Party; provided,
however, that Clinical Data does not include Sample Testing Results.
1.8.    “Clinical Quality Agreement” has the meaning set forth in Section 8.2.
1.9.    “CMC” means “Chemistry Manufacturing and Controls” as such term of art
is used in the pharmaceutical industry.
1.10.    “Combination” means the use or method of using the Company Compound and
the Merck Compound as individual formulations in concomitant or sequential
administration.
1.11.    “Company” has the meaning set forth in the preamble.
1.12.    “Company Background Patents” has the meaning set forth in Section
10.5.1.
1.13.    “Company Class Compound” means any small or large molecule that [ * ].
1.14.    “Company Compound” means Binimetinib (MEK 162), excluding, for clarity,
any generic version of MEK 162 other than a generic version Controlled by
Company or its Affiliate.
1.15.    “Company Inventions” has the meaning set forth in Section 10.2.
1.16.    “Compounds” means the Company Compound and the Merck Compound. A
“Compound” means either the Company Compound or the Merck Compound, as
applicable.
1.17.    “Confidential Information” means any information, Know-How or other
confidential or proprietary information or materials furnished to one Party
(“Receiving Party”) by the other Party (“Disclosing Party”) pursuant to this
Agreement, except to the extent that such information or materials: (a) was
already known by the Receiving Party or any of its Affiliates, other than under
an obligation of confidentiality, at the time of disclosure by the Disclosing
Party, as demonstrated by competent evidence; (b) was generally available to the
public or otherwise part of the public domain at the time of its disclosure to
the Receiving Party; (c) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the Receiving Party in breach of this Agreement; (d) was disclosed
to the Receiving Party by a Third Party who had no obligation to the Disclosing
Party not to disclose such information to others; or (e) was subsequently
developed by or on behalf of the Receiving Party or any of its Affiliates
without use of the Disclosing Party’s Confidential Information, as demonstrated
by competent evidence.
1.18.    “Continuing Party” has the meaning set forth in Section 10.1.3.
1.19.    “Control” or “Controlled” means, with respect to particular information
or intellectual property, that the applicable Party owns or has a license or
other rights 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.
1.20.    “CTA” has the meaning set forth in the definition of IND.
1.21.    “Data Sharing and Sample Testing Schedule” means the schedule attached
hereto as Schedule I.
1.22.    “Defending Party” has the meaning set forth in Section 14.2.3.
1.23.    “Delivery” with respect to the Merck Compound has the meaning set forth
in Section 8.4.1, and with respect to the Company Compound, the meaning set
forth in Section 8.4.2.
1.24.    “Direct Manufacturing Costs” has the meaning set forth in Section 6.11.
1.25.    “Disclosing Party” has the meaning set forth in the definition of
Confidential Information.
1.26.    “Disposition Package” has the meaning set forth in Section 8.8.1.
1.27.    “Dispute” has the meaning set forth in Section 21.1.
1.28.    “Effective Date” has the meaning set forth in the preamble.
1.29.    “EMA” has the meaning set forth in the definition of Applicable Law.
1.30.    “Exclusion List” has the meaning set forth in the definition of
Violation.
1.31.    “FDA” has the meaning set forth in the definition of Applicable Law.
1.32.    “Filing Party” has the meaning set forth in Section 10.1.3.
1.33.    “Final Study Report” has the meaning set forth in Section 3.11.
1.34.    “Force Majeure” has the meaning set forth Section 16.
1.35.    “GAAP” has the meaning set forth in Section 6.11.
1.36.    “GCP” means the Good Clinical Practices regulations, rules, and binding
guidance issued by EMA, FDA and the International Council for Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
that may be in effect from time to time and are applicable to the testing of the
Compounds.
1.37.    “Government Official” means: (a) any officer or employee of a
government or any department, agency or instrument of a government; (b) any
Person acting in an official capacity for or on behalf of a government or any
department, agency, or instrument of a government; (c) any officer or employee
of a company or business owned in whole or part by a government; (d) any officer
or employee of a public international organization such as the World Bank or
United Nations; (e) any officer or employee of a political party or any Person
acting in an official capacity on behalf of a political party; and/or (f) any
candidate for political office; who, when such Government Official is acting in
an official capacity, or in an official decision-making role, has responsibility
for performing regulatory inspections, government authorizations or licenses, or
otherwise has the capacity to make decisions with the potential to affect the
business of either of the Parties.
1.38.    “HIPAA” has the meaning set forth in the definition of Applicable Law.
1.39.    “IND” means any Investigational New Drug Application filed or to be
filed with the FDA as described in Title 21 of the U.S. Code of Federal
Regulations, Part 312, and the equivalent application in the jurisdictions
outside the United States (such equivalent application, a “CTA”), including an
“Investigational Medicinal Product Dossier” filed or to be filed with Regulatory
Authorities in the European Union.
1.40.    “Indemnifying Notice” has the meaning set forth in Section 14.2.3.
1.41.    “Indirect Manufacturing Costs” has the meaning set forth in Section
6.11.
1.42.    “Inventions” means all inventions and discoveries, whether or not
patentable, that are made, conceived, or first actually reduced to practice by
or on behalf of a Party or any of its Affiliates, or by or on behalf of the
Parties or any of their Affiliates together, (i) in the design or performance of
the Study or in the design or performance of any Phase III Study the Parties
agree to conduct together pursuant to Section 3.14 (including, for clarity, any
analysis conducted with respect thereto) or (ii) through use of unpublished
Clinical Data.
1.43.    “Joint Development Committee” or “JDC” has the meaning set forth in
Section 3.10.
1.44.    “Joint Patent Application” has the meaning set forth in Section 10.1.3.
1.45.    “Joint Patent” has the meaning set forth in Section 10.1.3.
1.46.    “Jointly Owned Clinical Data” has the meaning set forth in Section
3.8.1.
1.47.    “Jointly Owned Invention” has the meaning set forth in Section 10.1.1.
1.48.    “Know-How” means any invention, innovation, improvement, development,
discovery, computer program, trade secret, method, know-how, process, technique
or the like, including manufacturing, use, process, structural, operational and
other data and information, whether or not written or otherwise fixed in any
form or medium, regardless of the media on which contained and whether or not
patentable or copyrightable, that is not generally known or otherwise in the
public domain.
1.49.    “Liability” has the meaning set forth in Section 14.2.1.
1.50.    “Manufacture,” “Manufactured,” or “Manufacturing” means all activities
related to the manufacture of a Compound, including planning, purchasing,
manufacture, processing, compounding, storage, filling, packaging, waste
disposal, labeling, leafleting, testing, quality assurance, sample retention,
stability testing, release, dispatch and supply, as applicable.
1.51.    “Manufacturer’s Release” or “Release” has the meaning ascribed to such
term in the Clinical Quality Agreement.
1.52.    “Manufacturing Site” means the facilities where a Compound is
Manufactured by or on behalf of a Party, as such Manufacturing Site may change
from time to time in accordance with Section 8.7.
1.53.    “Merck” has the meaning set forth in the preamble.
1.54.    “Merck Background Patents” has the meaning set forth in Section 10.5.2.
1.55.    “Merck Compound” means pembrolizumab, a humanized anti-human PD-1
monoclonal antibody, excluding, however, any biosimilar version of pembrolizumab
other than a biosimilar version Controlled by Merck or its Affiliate.
1.56.    “Merck Inventions” has the meaning set forth in Section 10.3.
1.57.    “NDA” means a New Drug Application, Biologics License Application,
Marketing Authorization Application, filing pursuant to Section 510(k) of the
United States Federal Food, Drug and Cosmetic Act, or similar application or
submission for a marketing authorization of a product filed with a Regulatory
Authority to obtain marketing approval for a biological, pharmaceutical or
diagnostic product in that country or in that group of countries.
1.58.    “Non-Conformance” means, with respect to a given unit of Compound, (i)
an event that deviates in any material respect from an approved cGMP requirement
with respect to the applicable Compound, such as a procedure, Specification, or
operating parameter, or (ii) that such Compound failed to meet the applicable
representations and warranties set forth in Section 2.3. Classification of the
Non-Conformance is detailed in the Clinical Quality Agreement.
1.59.    “Non-Filing Party” has the meaning set forth in Section 10.1.3.
1.60.    “Other Party” has the meaning set forth in Section 14.2.3.
1.61.    “Opting-out Party” has the meaning set forth in Section 10.1.3.
1.62.    “Party” has the meaning set forth in the preamble.
1.63.    “PD-1 Antagonist” means any small or large molecule that blocks binding
of PD-L1 and/or PD-L2 to PD-1.
1.64.    “Person” means any individual, sole proprietorship, partnership,
corporation, business trust, joint stock company, trust, unincorporated
organization, association, limited liability company, institution, public
benefit corporation, joint venture, entity or governmental entity.
1.65.    “Pharmacovigilance Agreement” has the meaning set forth in Section 5.1.
1.66.    “[ * ]” has the meaning set forth in Section 3.14.1.
1.67.    “[ * ]” has the meaning set forth in Section 3.14.2.
1.68.    “[ * ]” has the meaning set forth in Section 3.14.2.
1.69.    “Project Manager” has the meaning set forth in Section 3.10.
1.70.    “Protocol” means the written documentation that describes the Study and
sets forth specific activities to be performed as part of the conduct of the
Study, a synopsis of which is attached hereto as Appendix A.
1.71.    “Receiving Party” has the meaning set forth in the definition of
Confidential Information.
1.72.    “Regulatory Approvals” means, with respect to a Compound, any and all
permissions (other than the Manufacturing approvals described in Section 2.3(c))
required to be obtained from Regulatory Authorities and any other competent
authority for the development, registration, sale, promotion, importation and
distribution of such Compound in the United States, Europe or any other
jurisdictions.
1.73.    “Regulatory Authorities” has the meaning set forth in the definition of
Applicable Law.
1.74.    “Regulatory Documentation” means, with respect to the Compounds, all
submissions to Regulatory Authorities in connection with the development of such
Compounds, including all INDs and amendments thereto, 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 that include Clinical Data).
1.75.    “Related Agreements” means the Pharmacovigilance Agreement, the
Clinical Quality Agreement and the agreement referenced in Section 4.3
(Financial Disclosure).
1.76.    “Right of Reference” means the “right of reference” defined in 21 CFR
314.3(b), including 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, only to the extent
necessary for the conduct of the Study 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.
1.77.    “SAEs” has the meaning set forth in Section 5.2.
1.78.    “Samples” means biological specimens collected from subjects
participating in the Study, including urine, blood and tissue samples.
1.79.    “Sample Testing” means the analyses to be performed by or on behalf of
each Party using the applicable Samples, as described in the Data Sharing and
Sample Testing Schedule.
1.80.    “Sample Testing Results” means those data (including raw data) and
results collected or generated from the Sample Testing performed by or on behalf
of a Party.
1.81.    “Specifications” means, with respect to a given Compound, the set of
requirements for such Compound as set forth in the Clinical Quality Agreement.
1.82.    “Study” means the Phase Ib clinical trial described in the Protocol to
evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary
efficacy of the concomitant and/or sequenced administration of the combination
of individual formulations of the Merck Compound and the Company Compound in
patients with colorectal cancer (the “Indication”).
1.83.    “Study Completion” has the meaning set forth in Section 3.11.
1.84.    “Subcontractors” has the meaning set forth in Section 2.4.
1.85.    “Term” has the meaning set forth in Section 6.1.
1.86.    “Third Party” means any Person or entity other than Company, Merck or
their respective Affiliates.
1.87.    “Toxicity & Safety Data” means all clinical adverse event information
and/or patient-related safety data included in the Clinical Data, as more fully
described in the Pharmacovigilance Agreement.
1.88.    “VAT” has the meaning set forth in Section 8.16.
1.89.    “Violation” means that a Party or any of its officers or directors or
any other personnel (or other permitted agents of a Party performing activities
hereunder) has been: (1) convicted of any offense for which (A) exclusion by the
U.S. Department of Health and Human Services Office of Inspector General (OIG)
is mandated or permitted pursuant to 42 U.S.C. 1320a-7(a), (b), or (c) or (B)
debarment is mandated or permitted pursuant to 21 U.S.C. 335a; or (2) identified
in the OIG List of Excluded Individuals/Entities (LEIE) database
(http://exclusions.oig.hhs.gov/), listed as having an active exclusion in the
System for Award Management (http://www.sam.gov), or listed by any other US
Federal agency as being suspended, proposed for debarment, debarred, excluded or
otherwise ineligible to participate in Federal procurement or non-procurement
programs (the “Exclusions Lists”).

2.Scope of the Agreement.

2.1.    Generally. Each Party shall: (a) contribute to the Study such resources
as are necessary to fulfill its obligations set forth in this Agreement; and (b)
act in good faith in performing its obligations under this Agreement and each
Related Agreement to which it is a Party.

2.2.    Manufacturing Delay. Each Party shall notify the other Party as promptly
as possible in the event of any Manufacturing delay that it reasonably believes
is likely to adversely affect supply of its Compound as contemplated by this
Agreement.

2.3.    Compound Commitments.
(a)Company agrees to Manufacture and supply the Company Compound for purposes of
the Study in accordance with Article 8, and Company hereby represents and
warrants to Merck that, at the time of Delivery of the Company Compound, such
Company Compound shall have been Manufactured and supplied in compliance with:
(i) the Specifications for the Company Compound; (ii) the Clinical Quality
Agreement; and (iii) all Applicable Law including cGMP and Applicable Laws with
respect to health and safety of subjects enrolled in the Study.
(b)Merck agrees to Manufacture and supply the Merck Compound for purposes of the
Study in accordance with Article 8, and Merck hereby represents and warrants to
Company that, at the time of Delivery of the Merck Compound, such Merck Compound
shall have been Manufactured and supplied in compliance with: (i) the
Specifications for the Merck Compound; (ii) the Clinical Quality Agreement; and
(iii) all Applicable Law, including cGMP and Applicable Laws with respect to
health and safety of subjects enrolled in the Study.
(c)Without limiting the foregoing, each Party is responsible for obtaining all
approvals from the applicable Regulatory Authorities (including facility
licenses) that are required to Manufacture its Compound in accordance with
Applicable Law (provided that, for clarity, Merck shall be responsible for
obtaining Regulatory Approvals for the Study as set forth in Section 3.4).

2.4.    Delegation of Obligations. Each Party shall have the right to delegate
any portion of its obligations hereunder as follows: (a) to such Party’s
Affiliates; (b) to contract research organizations or other Third Parties that
as of the Effective Date are conducting clinical trials of such Party’s Compound
and are set forth in the Protocol as performing such Study activities, or that
are conducting Sample Testing for such Party; (c) without restriction to the
extent related to the Manufacture of such Party’s Compound; and (d) upon the
written consent of the other Party. Any and all Third Parties to whom a Party
delegates any of its obligations hereunder are referred to as “Subcontractors”.
Notwithstanding any delegation of its obligations hereunder, each Party shall
remain solely and fully liable for the performance of its Affiliates and
Subcontractors to which such Party delegates the performance of its obligations
under this Agreement. Each Party shall ensure that each of its Affiliates and
Subcontractors performs such Party’s obligations pursuant to the terms of this
Agreement, including the Appendices and Schedules attached hereto. Each Party
shall be required to obtain and maintain copies of documents relating to the
obligations performed by such Affiliates and Subcontractors that are required to
be provided to the other Party under this Agreement.

2.5.    Compounds. Except as expressly set forth in Section 3.14, this Agreement
does not create any obligation on the part of Merck to provide the Merck
Compound for any activities other than the Study, nor does it create any
obligation on the part of Company to provide the Company Compound for any
activities other than the Study.

3.    Conduct of the Study.

3.1.    Sponsor. Merck shall act as the sponsor of the Study under its existing
IND for the Merck Compound with a Right of Reference to the IND of the Company
Compound as further described in Section 3.4; provided, however, that in no
event will Merck file a separate IND for the Study unless required by Regulatory
Authorities to do so. If a Regulatory Authority requests a separate IND for the
Study the Parties shall meet and mutually agree on an approach to address such
requirement.

3.2.    Performance. Merck shall ensure that the Study is performed in
accordance with this Agreement, the Protocol and all Applicable Law, including
GCP.

3.3.    Debarred Personnel; Exclusion Lists. Notwithstanding anything to the
contrary contained herein, neither Party shall employ or subcontract with any
Person that is excluded, debarred, suspended, proposed for suspension or
debarment, in Violation or otherwise ineligible to participate in government
programs for the performance of the Study or any other activities under this
Agreement or the Related Agreements. Each Party hereby certifies that it has not
employed or otherwise used in any capacity and will not employ or otherwise use
in any capacity, the services of any Person suspended, proposed for debarment,
or debarred under United States law, including 21 USC 335a, or any foreign
equivalent thereof, in performing any portion of the Study or other activities
under this Agreement or the Related Agreements and that each Party has, as of
the Effective Date, screened itself, and its officers and directors, against the
Exclusions Lists and that it has informed the other Party if it or any of its
officers or directors has been in Violation. Each Party shall notify the other
Party in writing immediately if any such suspension, proposed debarment,
debarment or Violation occurs or comes to its attention, and shall, with respect
to any Person so suspended, proposed for debarment, debarred or in Violation,
promptly remove such Person from performing activities, function or capacity
related to the Study or otherwise related to activities under this Agreement or
the Related Agreements.

3.4.    Regulatory Matters. Merck shall: (a) obtain, prior to initiating the
Study, all Regulatory Approvals required to conduct the Study from all
Regulatory Authorities, ethics committees and/or institutional review boards
with jurisdiction over the Study; and (b) follow all directives from any such
Regulatory Authorities, ethics committees and/or institutional review boards.
Company shall have the right (but not the obligation) to participate in any
discussions with a Regulatory Authority regarding matters related to the Company
Compound, and Merck shall provide the Company with reasonable prior written
notice of each such discussion and a copy of all material communications with
any Regulatory Authorities regarding matters related to the Company Compound and
the Combination, if there is determined to be a potential impact on the Company
Compound (and Merck shall allow Company to comment thereon, which comments Merck
shall reasonably consider addressing; provided that Merck shall incorporate all
such comments to the extent directed to the Company Compound). Each Party shall
provide to the other, as necessary, a cross-reference letter or similar
communication to the applicable Regulatory Authority to effectuate the Right of
Reference. Notwithstanding anything to the contrary in this Agreement, neither
Party shall have any right to access the other Party’s CMC data with respect to
its Compound. Company shall authorize FDA and other applicable Regulatory
Authorities to cross-reference the appropriate Company Compound INDs (including
CTAs) to provide CMC data access sufficient to support conduct of the Study. If
Company’s CTA is not available in a given country, to support conduct of the
Study, Company will file its CMC data with the Regulatory Authority for such
country, referencing Merck’s CTA as appropriate (however, Merck shall have no
right to directly access the CMC data).

3.5.    Documentation. Merck shall maintain records (including all reports and
related documentation) in sufficient detail and good scientific manner
(including for patent and regulatory purposes) and in compliance with Applicable
Law, which records shall reflect all work done and results achieved in the
Study. Merck shall provide to Company all Study information and documentation
reasonably requested by Company to enable Company to (a) comply with Applicable
Laws (including any of its legal and/or regulatory obligations) and/or its
contractual obligations, or any request by any Regulatory Authority, related to
the Company Compound or the Study and (b) determine whether the Study (including
any related analysis) has been performed in accordance with this Agreement.

3.6.    Copies. Merck shall provide to Company copies of all Clinical Data, in
electronic form or other mutually agreeable alternate form and on the timelines
specified in the Data Sharing and Sample Testing Schedule (if applicable) or
upon mutually agreeable timelines; provided, however, that a complete copy of
the Clinical Data shall be provided to Company no later than thirty (30) days
following Study Completion or ninety (90) days following termination of this
Agreement, whichever is earlier. Merck shall ensure that all patient
authorizations and consents required under HIPAA, the EU Data Protection
Directive or any other Applicable Law in connection with the Study permit such
sharing of Clinical Data with Company.

3.7.    Samples.
(a)Each Party shall use the Samples only for the Sample Testing and each Party
shall conduct the Sample Testing solely in accordance with the Data Sharing and
Sample Testing Schedule and the Protocol; provided that, for clarity, in no
event shall Company be required to conduct any Sample Testing. To the extent
outlined in the Protocol or Data Sharing and Sample Testing Schedule, Merck
shall provide Samples for Company Compound testing to Company, or its designated
third party contractor, for processing and testing (which processing and testing
shall be performed in the Company’s sole discretion). Merck shall own all Sample
Testing Results arising from Sample Testing related to the Merck Compound (but
not the Company Compound or the Combination) performed by or on behalf of Merck.
Merck shall provide to Company the Sample Testing Results for the Sample Testing
conducted by or on behalf of Merck, in electronic form or other mutually
agreeable alternate form, to the extent specified on the Data Sharing and Sample
Testing Schedule and on the timelines specified in the Data Sharing and Sample
Testing Schedule or as otherwise mutually agreed. Merck will be responsible for
exploratory PD-L1 protein measurements in tumor by immunohistochemistry (IHC)
and will share results with Company under the Data Sharing and Sample Testing
Schedule consistent with the following: (i) Merck will share only categorical
results of PD-L1 staining (typically “negative” or “positive”; occasionally
“negative,” “weak positive,” or “strong positive”) according to the scoring
method of the assay used; (ii) Merck will not share images (stained or
otherwise) and raw scores.
(b)Company shall own all Sample Testing Results arising from Sample Testing
exclusively related to the Company Compound (but not the Merck Compound or the
Combination). Company shall provide to Merck the Sample Testing Results for the
Sample Testing conducted by or on behalf of Company, in electronic form or other
mutually agreeable alternate form, to the extent specified on the Data Sharing
and Sample Testing Schedule and on the timelines specified in the Data Sharing
and Sample Testing Schedule or as otherwise mutually agreed.
(c)Except to the extent otherwise agreed in a writing signed by authorized
representatives of each Party, each Party may use and disclose the Sample
Testing Results owned by the other Party only for the purposes of (i) seeking
Regulatory Approval for the use of its respective Compound in the Combination
and (ii) filing and prosecuting patent applications for Jointly Owned Inventions
and enforcing any Joint Patents in accordance with Article 10.

3.8.    Ownership and Use of Clinical Data.
3.8.1.    All Clinical Data, including raw data and results, generated under
this Agreement shall be jointly owned by Company and Merck (the “Jointly Owned
Clinical Data”), with each Party having an undivided one-half interest. Without
additional compensation, Merck hereby assigns, and shall cause its Affiliates
and Subcontractors to assign, to Company an undivided one-half interest in, to
and under the Jointly Owned Clinical Data. Without additional compensation,
Company hereby assigns, and shall cause its Affiliates and Subcontractors to
assign, to Merck an undivided one-half interest n, to and under the Jointly
Owned Clinical Data. Prior to the completion of any such assignment, and if any
such assignment cannot occur because such assignment is precluded by law, the
Party with the obligation to assign its right, title and interest in, to and
under any applicable Clinical Data hereby grants the other Party, with respect
to the Jointly Owned Clinical Data, an exclusive (except as to the other Party),
perpetual, irrevocable, worldwide license, with the right to grant sublicenses
and to assign its license rights (subject to Section 3.8.2) to the Jointly Owned
Clinical Data to any Person, without the consent of the granting Party and
without any accounting to such Party. Merck shall maintain the Clinical Data in
its internal database; provided, however, that at all times during the Term,
Merck shall grant Company access to such Clinical Data.
3.8.2.    Notwithstanding the foregoing, before publication of the Jointly Owned
Clinical Data in accordance Article 12, neither Party may disclose the Jointly
Owned Clinical Data publicly or to a Third Party without the prior written
consent of the other Party and each Party’s use of Clinical Data is restricted
to: (1) seeking Regulatory Approval for use of such Party’s Compound in the
Combination; (2) prosecution and enforcement of Jointly Owned Inventions, with
respect to Merck, the Merck Inventions, and, with respect to Company, the
Company Inventions, in each case, pursuant to this Agreement; (3) conducting
research and additional clinical trials for the Combination; and (4) research
and development of its own Compound. The foregoing shall not limit or restrict
either Party’s ability to (A) use or disclose the Jointly Owned Clinical Data as
may be necessary to comply with Applicable Law or with such Party’s internal
policies and procedures with respect to pharmacovigilance and adverse event
reporting, (B) share with Third Parties or Affiliates Toxicity and Safety Data
where because of severity, frequency or lack of reversibility either Party needs
to use such Toxicity and Safety Data with respect to its own Compound or the
Combination to ensure patient safety, or (C) use or disclose the Jointly Owned
Clinical Data to a third party collaborator who has been engaged by the
disclosing Party to support development or commercialization of such disclosing
Party’s Compound, but only if such third party collaborator [ * ]. Such third
party collaborator must agree to be subject to the confidentiality and use
restrictions set forth in this Agreement. Uses of the unpublished Jointly Owned
Clinical Data are limited solely to those uses expressly set forth in this
Agreement, and all other uses by or on behalf of a Party or its Affiliates shall
require the prior written consent of the other Party. For clarity, and
notwithstanding anything to the contrary herein, (1) Merck hereby consents to
disclosure by or on behalf of the Company of the unpublished Jointly Owned
Clinical Data to Pierre Fabre Medicament SA (“PFD”); provided, that, prior to
sharing such unpublished Jointly Owned Clinical Data with PFD, PFD will be
subject to non-use and confidentiality provisions regarding such Jointly Owned
Clinical Data as stringent (including those set forth in Section 3.8 of this
Agreement) as those set forth herein and (2) nothing herein shall be construed
as granting Merck or Company any right or license, whether expressly or
impliedly, to make, have made, use, sell, offer for sale, import or export the
Company Compound or the Merck Compound, respectively.

3.9.    Regulatory Submission. It is understood and acknowledged by the Parties
that positive Clinical Data could be used to obtain label changes for the
Compounds, and each Party may propose a subsequent study or Study expansion in
connection therewith.

3.10.    Joint Development Committee.
3.10.1.    The Parties shall form a joint development committee (the “Joint
Development Committee” or “JDC”) made up of an equal number of representatives
of Merck and Company, (each Party’s representatives shall collectively have one
(1) vote for all matters to be considered by the JDC pursuant to the terms
hereof, which matters shall require unanimity), which shall have responsibility
for overseeing all regulatory and other activities with respect to conducting
the Study under, and pursuant to, this Agreement and such other matters to the
extent expressly set forth herein. Each Party shall designate a project manager
(the “Project Manager”), who shall be responsible for implementing and
coordinating activities and facilitating the exchange of information between the
Parties with respect to the Study. Each Party shall select its respective JDC
members; provided that each JDC member shall have appropriate seniority and
experience to serve on the JDC. The JDC shall meet as soon as practicable after
the Effective Date and then no less than twice yearly, and more often as
reasonably considered necessary at the reasonable request of either Party, to
provide an update on the progress of the Study. The JDC may meet in person or by
means of teleconference, Internet conference, videoconference or other similar
communications equipment. Prior to any such meeting, Merck’s Project Manager
shall provide an update in writing to Company’s Project Manager, which update
shall contain information about the overall progress of the Study, recruitment
status, interim analysis (if results available), final analysis and other
information relevant to the conduct of the Study. In addition to a Project
Manager, each Party shall designate an alliance manager (the “Alliance
Manager”), who shall not be a member of the JDC and shall endeavor to ensure
clear and responsive communication between the Parties and the effective
exchange of information and shall serve as the primary point of contact for any
issues arising under this Agreement. The Alliance Managers shall have the right
to attend all JDC meetings and may bring to the attention of the JDC any matters
or issues either of them reasonably believes should be discussed and shall have
such other responsibilities as the Parties may mutually agree in writing. Each
Party may change its JDC members, Alliance Manager and Project Manager from time
to time; provided that it provides written notice to the other Party and the
selected replacement satisfies those qualifications (if any) set forth in this
Section.
3.10.2.    The Parties’ respective Alliance Managers shall alternate
responsibility for preparing and circulating definitive minutes of each JDC
meeting, which minutes shall provide a reasonably detailed description of the
discussions, including a list of material decisions made, material issues not
resolved, and action items. The Parties shall reasonably cooperate to complete
and agree upon a final version of meeting minutes within ten (10) Business Days
from the date of the relevant meeting.
3.10.3.    The representatives of the JDC shall attempt in good faith to reach
consensus on all matters properly before the JDC. In the event that the JDC is
unable to unanimously agree on such a matter within twenty (20) Business Days of
such matter being brought to the JDC’s attention, then either Party may provide
written notice referring such issue for resolution to the Vice President of
Clinical Oncology for Merck and the Chief Medical Officer for Company
(collectively, the “Executive Officers”). In the event that the Executive
Officers, after good faith efforts, do not reach consensus within twenty (20)
Business Days of written notice referring such issue to the Executive Officers:
(a) Merck shall have final decision-making authority with respect to issues to
the extent exclusively related to Merck Compound; (b) Company shall have final
decision-making authority with respect to issues to the extent exclusively
related to Company Compound; and (c) all other matters shall be resolved in
accordance with Section 21. Notwithstanding anything to the contrary herein, the
JDC shall not have the ability to amend this Agreement or any of the Related
Agreements.

3.11.    Interim and Final Study Report. Merck shall update the JDC on any
interim Study analysis and interim Study data, including by providing electronic
draft copies of any interim Study reports and analysis if prepared by Merck.
Merck shall provide Company with an electronic draft of the final study report
(including any statistical analysis in accordance with the statistical analysis
plan) promptly following Study Completion. Company shall have thirty (30) days
after receipt of such draft final study report to provide comments thereon.
Merck shall consider in good faith any comments provided by Company on the draft
final study report, shall not include any statements relating to the Company
Compound that have not been approved by Company, and shall reasonably accept all
comments provided by Company to the extent relating to the Company Compound.
Merck shall deliver to Company a final version of the final study report
promptly following finalization thereof (the “Final Study Report”). “Study
Completion” shall occur upon final database lock of the Study results.

3.12.    Relationship. Except as expressly set forth in this Agreement, nothing
in this Agreement shall: (a) prohibit either Party from performing clinical
studies other than the Study relating to its own Compound, either individually
or in combination with any other compound or product, in any therapeutic area;
or (b) create an exclusive relationship between the Parties with respect to any
Compound. Each Party acknowledges and agrees that nothing in this Agreement
shall be construed as a representation or inference that the other Party will
not develop for itself, or enter into business relationships with other Third
Parties regarding, any products, programs, studies (including combination
studies), technologies or processes that are similar to or that may compete with
the Combination or any other product, program, technology or process, including
Company Class Compound or PD-1 Antagonists, provided that the Clinical Data,
Confidential Information, Jointly Owned Inventions and Sample Testing Results
are not used or disclosed in connection therewith in violation of this
Agreement.

3.13.    Licensing. Nothing in this Agreement shall prohibit or restrict a Party
from licensing, assigning or otherwise transferring to an Affiliate or Third
Party its Compound and the related Clinical Data, Confidential Information,
Jointly Owned Inventions or Sample Testing Results; provided, however, that in
the case of any such license, assignment or transfer of any Clinical Data, the
other Party's Confidential Information, Jointly Owned Inventions or the other
Party's Sample Testing Results, the licensee, assignee or transferee shall agree
in writing to be bound by the terms of this Agreement with respect to such
Clinical Data, Confidential Information, Jointly Owned Inventions or Sample
Testing Results. For purposes of clarity, any assignment or transfer of this
Agreement must comply with Section 18 of this Agreement.

3.14.    Subsequent Study.
3.14.1.    During either (i) the [ * ] and for a period of [ * ] thereafter, or
(ii) the term of the Agreement and for a period of [ * ] thereafter, whichever
is sooner, either Party shall have the option to propose amending this Agreement
and the Related Agreements or entering into a new agreement for the purpose of
an expansion of the Study to [ * ] (the “[ * ]”).
3.14.2.    The Parties shall discuss in good faith any such proposal, but will
have no obligation to agree to move forward with the [ * ]. The terms of an
agreement or amendment governing [ * ] (a “[ * ]”) will contain substantially
similar ownership and use of clinical data and intellectual property terms as
are set forth in this Agreement. Any proposal to collaborate on [ * ] shall
include details related to which Party would sponsor such Study, a full and
final protocol, how costs would be shared, and, if costs are shared, a budget
(“[ * ]”). Any [ * ]shall be sent by the proposing Party to the other Party at
least three (3) months prior to the proposed initiation of such [ * ]. In such
case, the Parties shall discuss in good faith any such proposal, but will have
no obligation to commit to the [ * ]. In any event, prior to[ * ].

4.    Protocol and Certain Other Documents.

4.1.    Protocol. A synopsis of the initial Protocol has been agreed to by the
Parties as of the Effective Date and is attached hereto as Appendix A. Merck
shall (a) provide a draft of the Protocol and the statistical analysis plan (and
any subsequent revisions and amendments thereof) to Company for Company’s review
and comment, (b) consider in good faith any changes to the draft of the Protocol
and statistical analysis plan requested by Company, and (c) notwithstanding the
foregoing subsection (b), incorporate any changes requested by Company with
respect to Company Compound. The Protocol, the statistical analysis plan, and
any amendments thereto shall be finalized with the approval of the JDC, subject
to each Party’s decision-making rights as set forth herein. Notwithstanding the
foregoing, to the extent there is a disagreement between the Parties’ respective
representatives on the JDC regarding the contents of the Protocol, the
statistical analysis plan, or any amendment thereto, Merck shall have final
decision-making authority if such dispute is not resolved following escalation
to the Executive Officers in accordance with Section 3.10; provided, however,
that any material changes to any draft of the Protocol (other than material
changes relating solely to the Merck Compound) from the draft of the Protocol
previously provided to Company, any material changes to the approved final
Protocol (other than material changes relating solely to the Merck Compound),
and any changes to any draft of the Protocol or approved final Protocol (whether
or not material) relating to the Company Compound (including with respect to the
quantities and/or presentations of Company Compound to be provided for the Study
and/or the timing for Delivery thereof), shall require Company’s prior written
consent. Any such proposed changes will be sent in writing to Company’s Project
Manager and Company’s Alliance Manager. Company will provide such consent, or a
written explanation for why such consent is being withheld, within fifteen (15)
Business Days after Company receives a copy of Merck’s requested changes,
provided, that if Company fails to provide such written explanation within such
15 Business Day period, then Company shall be deemed to have consented to such
change or changes.
4.1.1.    Notwithstanding anything to the contrary contained herein, Merck, in
its sole discretion, shall have the sole right to determine the dose and dosing
regimen for the Merck Compound and shall have the final decision on all matters
relating to the Merck Compound (including quantities of Merck Compound to be
supplied pursuant to Article 8) and any information regarding the Merck Compound
included in the Protocol and the statistical analysis plan related thereto.
4.1.2.    Notwithstanding anything to the contrary contained herein, Company, in
its sole discretion, shall have the sole right to determine the dose and dosing
regimen for the Company Compound and shall have the final decision on all
matters relating to the Company Compound (including quantities of Company
Compound to be supplied pursuant to Article 8) and any information regarding the
Company Compound included in the Protocol and the statistical analysis plan
related thereto.

4.2.    Informed Consent. Merck shall prepare the patient informed consent form
for the Study (which shall include provisions regarding the use of Samples in
Sample Testing) in consultation with Company (it being understood and agreed
that the portion of the informed consent form relating to the Sample Testing of
the Company Compound shall be provided to Merck by Company). Any proposed
changes to such form that relate to the Company Compound, including Sample
Testing of the Company Compound, shall be subject to Company’s prior written
consent. Any such proposed changes will be sent in writing to Company’s Project
Manager and Company’s Alliance Manager. Company will provide such consent, or a
written explanation for why such consent is being withheld, within fifteen (15)
Business Days after Company receives a copy of Merck’s requested changes,
provided, that if Company fails to provide such written explanation within such
15 Business Day period, then Company shall be deemed to have consented to such
change or changes.

4.3.    Financial Disclosure. Merck will (a) track and collect financial
disclosure information from all “clinical investigators” involved in the Study
and (b) prepare and submit the certification and/or disclosure of the same in
accordance with all Applicable Law, including, but not limited to, Part 54 of
Title 21 of the United States Code of Federal Regulations (Financial Disclosure
by Clinical Investigators) and related FDA Guidance Documents. Prior to the
initiation of clinical activities under the Study, but in any event within 60
days after the Effective Date, the Parties shall determine, in writing, whether
Merck will track and collect from all “clinical investigators” involved in the
Study separate certification and/or disclosure forms for each of Merck and
Company or one (1) “combined” certification and/or disclosure form for both
Merck and Company. For purposes of this Section 4.3, the term “clinical
investigators” shall have the meaning set forth in Part 54.2(d) of Title 21 of
the United States Code of Federal Regulations.
4.4.    Transparency Reporting.
4.4.1.    With respect to any annual reporting period in which Company is not an
entity that is required to make a Transparency Report under Applicable Law,
Company will: (a) notify Merck, in writing, within thirty (30) days after the
commencement of such reporting period that Company is not so required; and (b)
during such reporting period Company will track and provide to Merck data
regarding “indirect” payments or other transfers of value by Company to health
care professionals to the extent such payments or other transfers of value were
required, instructed, directed or otherwise caused by Merck pursuant to this
Agreement in the format requested by Merck and provided on a basis to be agreed
upon by both Parties. Company represents and warrants that any data provided by
Company to Merck pursuant to Section 4.4.1(b) above will be complete and
accurate to the best of Company’s knowledge.
4.4.2.    With respect to any annual reporting period in which Company is
required to make a Transparency Report under Applicable Law, Company will
provide to Merck, in writing, Company’s point of contact for purposes of
receiving information from Merck pursuant to this Section 4.4, along with such
contact’s full name, email address, and telephone number. Company may update
such contact from time to time by notifying Merck in writing pursuant to Section
22 (Notices). Where applicable, Merck will provide to such Company contact all
information regarding the value of the Merck Compound provided for use in the
Study required for such reporting. In the event that the value of the Merck
Compound provided pursuant to this Section 4.4.2 changes, Merck shall notify
Company of such revised value and the effective date thereof.
4.4.3.    For purposes of this Section 4.4, “Transparency Report” means a
transparency report in connection with reporting payments and other transfers of
value made to health care professionals, including, without limitation,
investigators, steering committee members, data monitoring committee members,
and consultants in connection with the Study in accordance with reporting
requirements under Applicable Law, including, without limitation, the Physician
Payment Sunshine Act and state gift laws, and the European Federation of
Pharmaceutical Industries and Associations Disclosure Code, or a Party’s
applicable policies.

5.    Adverse Event Reporting.

5.1.    Pharmacovigilance Agreement. Merck will be solely responsible for
compliance with all Applicable Laws pertaining to safety reporting for the Study
and related activities. The Parties will execute a pharmacovigilance agreement
(“Pharmacovigilance Agreement”) prior to the initiation of clinical activities
under the Study, but in any event within sixty (60) days after the Effective
Date, to ensure the exchange of relevant safety data within appropriate
timeframes and in an appropriate format to enable the Parties to fulfill local
and international regulatory reporting obligations and to facilitate appropriate
safety reviews. In the event of any inconsistency between the terms of this
Agreement and the Pharmacovigilance Agreement, the terms of this Agreement shall
control. The Pharmacovigilance Agreement will include safety data exchange
procedures governing the coordination of collection, monitoring, investigation,
reporting, and exchange of information concerning any adverse experiences,
pregnancy reports, and any other safety information arising from or related to
the use of the Merck Compound and Company Compound in the Study, consistent with
Applicable Law. Such guidelines and procedures shall be in accordance with, and
enable the Parties and their Affiliates to fulfill, local, national,
international and any other regulatory reporting obligations to Regulatory
Authorities under Applicable Law.

5.2.    Transmission of SAEs. Pursuant to such Pharmacovigilance Agreement,
Merck will transmit to Company all serious adverse events (“SAEs”) as follows:  
5.2.1.    For Company Compound fatal and life-threatening SAEs, Merck will send
processed CIOMS-1 forms (in English) within five (5) calendar days after receipt
by Merck of such SAEs.
5.2.2.    For all other Company Compound SAEs, including non-drug-related fatal
and life-threatening SAEs, Merck will send processed CIOMS-1 forms (in English)
within seven (7) calendar days after receipt by Company of such SAEs.

6.    Term and Termination.

6.1.    Term. The term of this Agreement shall commence on the Effective Date
and shall continue in full force and effect until delivery of the Final Study
Report or until terminated by either Party pursuant to this Article 6 (the
“Term”).

6.2.    Company Termination Right for Safety. In the event that Company in good
faith believes that the Company Compound is being used in the Study in an unsafe
manner and notifies Merck in writing of the grounds for such belief, and Merck
fails to promptly incorporate (subject to approval by applicable Regulatory
Authorities or Institutional Review Boards) changes into the Protocol reasonably
requested by Company to address such issue or to otherwise resolve such issue
reasonably and in good faith, Company may terminate this Agreement and the
supply of the Company Compound effective immediately upon written notice to
Merck.

6.3.    Material Breach. Either Party may terminate this Agreement if the other
Party commits a material breach of this Agreement, and such material breach
continues for thirty (30) days after receipt of written notice thereof from the
non-breaching Party; provided that if such material breach cannot reasonably be
cured within thirty (30) days, the breaching Party shall be given a reasonable
period of time to cure such breach; provided further, that if such material
breach is incapable of cure, then the notifying Party may terminate this
Agreement effective after the expiration of such thirty (30) day period.

6.4.    Mutual Termination Right for Patient Safety. If either Party reasonably
determines in good faith, based on a review of the Clinical Data, Sample Testing
Results or other Study-related Know-How or other information, that the Study may
unreasonably affect patient safety, health or welfare, such Party shall promptly
notify the other Party of such determination. The Party receiving such notice
may propose modifications to the Study to address the safety issue identified by
the other Party and, if the notifying Party agrees, shall act to implement
immediately such modifications; provided, however, that if the notifying Party,
in its sole discretion, reasonably believes that there is imminent danger to
patients, such Party need not wait for the other Party to propose modifications
and may instead terminate this Agreement immediately upon written notice to such
other Party. Furthermore, if the notifying Party, in its sole discretion,
believes that any modifications proposed by the other Party will not resolve the
patient safety issue, such Party may terminate this Agreement effective
immediately upon written notice to such other Party.

6.5.    Mutual Termination Right Due to Regulatory Action; Other Reasons. Either
Party may terminate this Agreement upon written notice to the other Party in the
event that any Regulatory Authority takes any action, or raises any objection,
that prevents the terminating Party from supplying its Compound for purposes of
the Study; provided that the Parties shall first meet to discuss the basis for
such action or objection and how the Parties might address such matter. If,
following conclusion of such discussions, or within ten (10) Business Days of
such termination of supply, whichever is earlier, either Party reasonably
concludes that the issue is not solvable or material additional costs and delays
have been or will be incurred as a result of such issue, then such Party shall
have the right to immediately terminate this Agreement upon written notice to
the other Party. Additionally, either Party shall have the right to terminate
this Agreement immediately upon written notice to the other Party in the event
that it determines in its sole discretion to withdraw any applicable Regulatory
Approval for its Compound or to discontinue development of its Compound, for
medical, scientific, legal or other reasons.

6.6.    Return of Company Compound. In the event that this Agreement is
terminated, or in the event Merck remains in possession (including through any
Affiliate or Subcontractor) of Company Compound at the time this Agreement
expires, Merck shall, at Company’s sole discretion, promptly either return or
destroy all unused Company Compound pursuant to Company’s instructions. If
Company requests that Merck destroy the unused Company Compound, Merck will
provide written certification of such destruction.

6.7.    Anti-Corruption. Either Party shall have the right to terminate this
Agreement immediately upon written notice to the other Party, if such other
Party fails to perform any of its obligations under Section 13.4 or breaches any
representation or warranty contained in Section 13.4. Except as set forth in
Section 6.11, the non-terminating Party shall have no claim against the
terminating Party for compensation for any loss of whatever nature by virtue of
the termination of this Agreement in accordance with this Section 6.7.

6.8.    Survival. The provisions of Sections 3.4 through 3.9 (inclusive), 3.14
(for the period of time set forth in such Section), 4.3, 4.4, 6.6, 6.7 (second
sentence) through 6.11 (inclusive), 8.11, 8.14 through 8.16 (inclusive),
10.1-10.4, 12.2, 13.4.6, 14.2, and 14.3, and Articles 1, 5, 9, 11 through 12
(inclusive), 15, 17 through 25 (inclusive) shall survive the expiration or
termination of this Agreement.

6.9.    No Prejudice. Termination of this Agreement shall be without prejudice
to any claim or right of action of either Party against the other Party for any
prior breach of this Agreement.

6.10.    Confidential Information. Upon termination of this Agreement, each
Party and its Affiliates shall promptly return to the Disclosing Party or
destroy any Confidential Information of the Disclosing Party (other than
Clinical Data, Sample Testing Results and Inventions) furnished to the Receiving
Party by the Disclosing Party; provided, however that the Receiving Party may
retain one copy of such Confidential Information in its confidential files,
solely for purposes of exercising the Receiving Party’s rights hereunder,
satisfying its obligations hereunder or complying with any legal proceeding or
requirement with respect thereto, and provided further that the Receiving Party
shall not be required to erase electronic files created in the ordinary course
of business during automatic system back-up procedures pursuant to its
electronic record retention and destruction practices that apply to its own
general electronic files and information so long as such electronic files are
(i) maintained only on centralized storage servers (and not on personal
computers or devices), (ii) not accessible by any of its personnel (other than
its information technology specialists), and (iii) are not otherwise accessed
subsequently except with the prior written consent of the Disclosing Party or as
required by law or legal process. Such retained copies of Confidential
Information shall remain subject to the confidentiality and non-use obligations
herein.

6.11.    Manufacturing Costs. In the event of termination pursuant to Sections
6.3 or 6.7 above, the terminating Party shall be entitled to reimbursement by
the other Party for the Direct Manufacturing Costs and Indirect Manufacturing
Costs (as defined herein) incurred by the terminating Party for its Compound
Delivered for the Study. “Direct Manufacturing Costs” shall be calculated
consistent with Generally Accepted Accounting Principles (“GAAP”) and include
manufacturing fees, raw materials, direct labor, freight and duty, and factory
overhead costs that can be directly attributed to the Compound, including but
not limited to equipment maintenance and repair, supplies, ongoing stability
program costs, other plant services, indirect labor and depreciation on direct
capital assets. “Indirect Manufacturing Costs” shall be calculated consistent
with GAAP and include allocations of indirect factory overhead and site support
costs, including but not limited to utilities, quality, planning, engineering,
maintenance, safety, site science and technology, and depreciation on indirect
capital assets, procurement, warehousing, and corporate services. Allocations
shall be based on each Compound’s utilization relative to a Manufacturing Site’s
total manufacturing activity.

7.    Costs of Study. The Parties agree that: (a) Company shall provide the
Company Compound for use in the Study, as described in Article 8 below; (b) each
Party will be responsible for its own internal costs and expenses to support its
obligations hereunder with respect to the Study and the costs of any Sample
Testing conducted by such Party in connection with the Study; and (c) Merck
shall bear all other costs associated with the conduct of the Study, including
that Merck shall provide the Merck Compound for use in the Study, as described
in Article 8 below. For the avoidance of doubt, Merck will not be required to
reimburse Company for any costs or expenses incurred by Company or its
Affiliates in connection with the Study (except as provided in Section 6.11) and
Company will not be required to reimburse Merck for any costs or expenses
incurred by Merck or its Affiliates in connection with the Study (except as
provided in Section 6.11).

8.    Supply and Use of the Compounds.

8.1.    Supply of the Compounds. Subject to the terms and conditions of this
Agreement, each of Company and Merck will use commercially reasonable efforts to
supply, or cause to be supplied, at no cost to the other Party, the quantities
of its respective Compound as are set forth in Appendix B, on the timelines set
forth in Appendix B, in each case for use in the Study. If the Protocol is
changed in accordance with Section 4 in such a manner that may affect the
quantities of Compound to be provided or the timing for providing such
quantities, the Parties shall amend Appendix B to reflect any changes required
to be consistent with the Protocol. Each Party shall also provide to the other
Party a contact person for the supply of its Compound under this Agreement.
Notwithstanding the foregoing, or anything to the contrary herein, in the event
that either Party is not supplying its Compound in material compliance with the
terms of this Agreement and fails to cure such breach in accordance with those
cure provisions set forth in Section 6.3, or is allocating under Section 8.10,
in addition to and without limiting any other remedies hereunder or otherwise
available, then the other Party shall have no obligation to supply its Compound,
or may allocate proportionally, respectively.

8.2.    Clinical Quality Agreement. No later than forty five (45) days from the
Effective Date of this Agreement, but in any event before any supply is
delivered under this Agreement, the Parties shall enter into a quality agreement
that shall address and govern issues related to the quality of clinical drug
supply to be supplied by the Parties for use in the Study (“Clinical Quality
Agreement”). In the event of any inconsistency between the terms of this
Agreement and the Clinical Quality Agreement, the terms of this Agreement shall
control. The Clinical Quality Agreement shall, among other things: (i) detail
classification of any Compound found to have a Non-Conformance; (ii) include
criteria for Manufacturer’s Release and related certificates and documentation;
(iii) include criteria and timeframes for acceptance of Merck Compound; (iv)
include procedures for the resolution of disputes regarding any Compounds found
to have a Non-Conformance; and (v) include provisions governing the recall of
Compounds.

8.3.    Minimum Shelf Life Requirements. Each Party shall use commercially
reasonable efforts to supply its Compound hereunder with an adequate remaining
shelf life at the time of Delivery to meet the Study requirements.

8.4.    Provision of Compounds.
8.4.1.    Company will deliver the unlabeled Company Compound DAP (INCOTERMS
2010) to Merck’s, or its designee’s, location as specified by Merck (“Delivery”
with respect to such Company Compound). Title and risk of loss for the Company
Compound shall transfer from Company to Merck at Delivery. All costs associated
with the subsequent transportation, warehousing and distribution of Company
Compound (including shipment to clinical trial sites) shall be borne by Merck.
Merck will, or will cause its designee to: (i) take delivery of the unlabeled
Company Compound supplied hereunder; (ii) perform the acceptance (including
testing) procedures allocated to it under the Clinical Quality Agreement; (iii)
subsequently label and pack the Company Compound (in accordance with Section
8.5), and promptly ship the Company Compound to the Study sites for use in the
Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical
Quality Agreement; and (iv) provide, from time to time at the reasonable request
of Company, the following information: any applicable chain of custody forms,
in-transport temperature recorder(s), records and receipt verification
documentation, such other transport or storage documentation as may be
reasonably requested by Company, and usage and inventory reconciliation
documentation related to the Company Compound.
8.4.2.    Merck is solely responsible, at its own cost, for supplying (including
all Manufacturing, acceptance and release testing) the Merck Compound for the
Study, and the subsequent handling, storage, transportation, warehousing and
distribution of the Merck Compound supplied hereunder. Merck shall ensure that
all such activities are conducted in compliance with cGMP, GCP and other
Applicable Law and the Clinical Quality Agreement. For purposes of this
Agreement, the “Delivery” of a given quantity of the Merck Compound shall be
deemed to occur when such quantity is packaged for shipment to a Study site.

8.5.    Labeling and Packaging; Use, Handling and Storage.
8.5.1.    The Parties’ obligations with respect to the labeling and packaging of
the Compounds shall be as set forth in the Clinical Quality Agreement.
Notwithstanding the foregoing or anything to the contrary contained herein,
Company shall provide the Company Compound to Merck in the form of unlabeled
bottles, and Merck shall be responsible for labeling, secondary packaging and
leafleting such Company Compound in accordance with the terms and conditions of
the Clinical Quality Agreement and otherwise in accordance with all Applicable
Law, including cGMP, GCP, and health, safety and environmental protections (and
promptly following Company’s request, Merck shall provide Company with
representative samples of such labeling (i.e. clinical label proof), packaging
(i.e. component specifications), and leafleting (if applicable) for Company’s
review).
8.5.2.    Merck shall: (i) use the Company Compound solely for purposes of
performing the Study in accordance with the terms hereof; (ii) not use the
Company Compound in any manner that is inconsistent with this Agreement or for
any commercial purpose; and (iii) label, use, store, transport, handle and
dispose of the Company Compound in compliance with Applicable Law and the
Clinical Quality Agreement, as well as all instructions of Company with respect
thereto. Notwithstanding anything to the contrary herein, Merck shall not
reverse engineer, reverse compile, disassemble or otherwise attempt to derive
the composition or underlying information, structure or ideas of the Company
Compound, and in particular shall not analyze the Company Compound by physical,
chemical or biochemical means except to the extent expressly described in and
necessary to perform its obligations under the Clinical Quality Agreement.

8.6.    Product Specifications. A certificate of analysis shall accompany each
shipment of the Company Compound to Merck. Upon request, Merck shall provide
Company with a certificate of analysis covering each shipment of Merck Compound
used in the Study.

8.7.    Changes to Manufacturing. Each Party may make changes from time to time
to its Compound or the Manufacturing Site, provided that such changes shall be
in accordance with the Clinical Quality Agreement.

8.8.    Product Testing; Noncompliance.
8.8.1.    After Manufacturer’s Release. After Manufacturer’s Release of the
Company Compound and concurrently with Delivery of the Compound to Merck,
Company shall provide Merck with such certificates and documentation as are
described in the Clinical Quality Agreement (“Disposition Package”). Merck
shall, within the time defined in the Clinical Quality Agreement, perform with
respect to the Company Compound, the acceptance (including testing) procedures
allocated to it under the Clinical Quality Agreement. Merck shall be solely
responsible for taking all steps necessary to determine that Merck Compound or
Company Compound, as applicable, is suitable for release before making such
Merck Compound or Company Compound, as applicable, available for human use, and
Company shall provide cooperation or assistance as reasonably requested by Merck
in connection with such determination with respect to the Company Compound.
Merck shall be responsible for storage and maintenance of the Company Compound
until it is tested and/or released, which storage and maintenance shall be in
compliance with (a) the Specifications for the Company Compound, the Clinical
Quality Agreement and Applicable Law and (b) any specific storage and
maintenance requirements as may be provided by Company from time to time. Merck
shall be responsible for any failure of the Company Compound to meet the
Specifications to the extent caused by shipping, storage, handling or other
conditions or circumstances after Delivery to Merck hereunder.
8.8.2.    Non-Conformance.
(a)In the event that either Party becomes aware that any Compound may have a
Non-Conformance, despite testing and quality assurance activities (including any
activities conducted by the Parties under Section 8.8.1), such Party shall
immediately notify the other Party in accordance with the procedures of the
Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in
accordance with Section 8.9 (Investigations) and any discrepancy between them
shall be resolved in accordance with Section 8.8.3.
(b)In the event that any proposed or actual shipment of the Company Compound (or
portion thereof) shall be agreed to have a Non-Conformance at the time of
Delivery to Merck, then unless otherwise agreed to by the Parties, Company shall
replace such Company Compound as is found to have a Non-Conformance (with
respect to Company Compound that has not yet been administered in the course of
performing the Study). Unless otherwise agreed to by the Parties in writing, the
sole and exclusive remedies of Merck with respect to any Company Compound that
is found to have a Non-Conformance at the time of Delivery shall be (i)
replacement of such Company Compound as set forth in this Section 8.8.2(b) if
such Company Compound has not yet been administered in the course of performing
the Study, or (ii) if such Company Compound has been administered in the course
of performing the Study, indemnification under and subject to Section 14.2.2 (to
the extent applicable) and termination of this Agreement pursuant and subject to
Section 6.3 (to the extent applicable, but subject to the applicable cure
periods set forth therein); provided that, for clarity, Merck shall not be
deemed to be waiving any rights under Section 8.15. In the event Company
Compound is lost or damaged by Merck after Delivery, Company shall provide
additional Company Compound (if available for the Study) to Merck; provided that
Merck shall reimburse Company for the Direct Manufacturing Costs and Indirect
Manufacturing Costs (as such terms are defined in Section 6.11) of such replaced
Company Compound; and provided further that except as set forth in the foregoing
clause, Company shall have no obligation to provide replacement Company Compound
for any Company Compound supplied hereunder other than such Company Compound as
has been agreed or determined to have a Non-Conformance at the time of Delivery
to Merck.
(c)Notwithstanding anything to the contrary herein, Merck shall be responsible
for, and Company shall have no obligation or liability with respect to, any
Merck Compound supplied hereunder that is found to have a Non-Conformance. Merck
shall replace any Merck Compound as is found to have a Non-Conformance (with
respect to Merck Compound that has not yet been administered in the course of
performing the Study). Unless otherwise agreed to by the Parties in writing, the
sole and exclusive remedies of Company with respect to any Merck Compound that
is found to have a Non-Conformance at the time of Delivery shall be (i) if such
Merck Compound has not yet been administered in the course of performing the
Study, replacement of such Merck Compound as set forth in this Section 8.8.2(b),
or (ii) if such Merck Compound has been administered in the course of performing
the Study, indemnification under Section 14.2.1 (to the extent applicable), and
termination of this Agreement pursuant to Section 6.3 (to the extent applicable,
but subject to the applicable cure periods set forth therein); provided that,
for clarity, Company shall not be deemed to be waiving any rights under Section
8.15.
8.8.3.    Resolution of Discrepancies. Disagreements regarding any determination
of Non-Conformance by Merck shall be resolved in accordance with the provisions
of the Clinical Quality Agreement.

8.9.    Investigations. The process for investigations of any Non-Conformance
shall be handled in accordance with the Clinical Quality Agreement.

8.10.    Shortage; Allocation. In the event that a Party’s Compound is in short
supply such that a Party reasonably believes in good faith that it will not be
able to fulfill its supply obligations hereunder with respect to its Compound,
such Party will provide prompt written notice to the other Party thereof
(including the shipments of Compound hereunder expected to be impacted and the
quantity of its Compound that such Party reasonably determines it will be able
to supply) and the Parties will promptly discuss such situation (including how
the quantity of Compound that such Party is able to supply hereunder will be
allocated within the Study). In such event, the Party experiencing such shortage
shall (i) use its commercially reasonable efforts to remedy the situation giving
rise to such shortage and to take action to minimize the impact of the shortage
on the Study, and (ii) allocate to the other Party an amount of Compound at
least proportionate to the total amount of the Compound shipments hereunder
expected to be impacted by the shortage divided by the total demand for the
Compound for the impacted time period.

8.11.    Records; Audit Rights. Merck shall keep complete and accurate records
pertaining to its use and disposition of Company Compound (including its
storage, shipping (cold chain) and chain of custody activities) and, upon
request of Company, shall make such records open to review by Company solely for
the purpose of conducting investigations for the determination of Company
Compound safety and/or efficacy and Merck’s compliance with this Agreement with
respect to the Company Compound.

8.12.    Quality. Quality matters related to the Manufacture of the Compounds
shall be governed by the terms of the Clinical Quality Agreement in addition to
the relevant quality provisions of this Agreement.

8.13.    Quality Control. Each Party shall implement and perform operating
procedures and controls for sampling, stability and other testing of its
Compound, and for validation, documentation and release of its Compound and such
other quality assurance and quality control procedures as are required by the
Specifications, cGMPs and the Clinical Quality Agreement.

8.14.    Audits and Inspections. The Parties’ audit and inspection rights
related to this Agreement shall be governed by the terms of the Clinical Quality
Agreement.

8.15.    Recalls. Recalls of the Compounds shall be governed by the terms of the
Clinical Quality Agreement.

8.16.    VAT. It is understood and agreed between the Parties that any payments
made and any other consideration given under this Agreement are each exclusive
of any value added or similar tax (“VAT”), which shall be added thereon as
applicable and at the relevant rate. Subject to Section 8.16(b), where VAT is
properly charged by the supplying Party and added to a payment made or other
consideration provided (as applicable) under this Agreement, the Party making
the payment or providing the other consideration (as applicable) will pay the
amount of VAT properly chargeable only on receipt of a valid tax invoice from
the supplying Party issued in accordance with the laws and regulations of the
country in which the VAT is chargeable.  Each Party agrees that it shall provide
to the other Party any information and copies of any documents within its
Control to the extent reasonably requested by the other Party for the purposes
of (i) determining the amount of VAT chargeable on any supply made under this
Agreement, (ii) establishing the place of supply for VAT purposes, or (iii)
complying with its VAT reporting or accounting obligations.

9.
Confidentiality.

9.1.    Confidential Information. Subject to Section 13.4.8, Company and Merck
agree to hold in confidence any Confidential Information provided by or on
behalf of the other Party, and neither Party shall use Confidential Information
of the other Party except to fulfill such Party’s obligations under this
Agreement or exercising its rights, in each case, to the extent expressly
provided for hereunder. Without limiting the foregoing, the Receiving Party may
not, without the prior written permission of the Disclosing Party, disclose any
Confidential Information of the Disclosing Party to any Third Party.
Notwithstanding the foregoing, the Receiving Party may disclose the Disclosing
Party’s Confidential Information to the extent reasonably necessary (i) if
required by Applicable Law; (ii) to patent authorities in connection with filing
and prosecuting patents to the extent permitted hereunder; (iii) to its
Affiliates, employees, agents and independent contractors, in each case, on a
need-to-know basis and solely in connection with exercise of its rights
(including furthering the development, manufacture or commercialization of the
Receiving Party’s respective Compound as permitted by the terms of this
Agreement) or performance of its obligations hereunder; and in each case of
subsection (i) and (ii), provided that the Receiving Party shall provide
reasonable advance notice to the Disclosing Party before making such disclosure
to the extent reasonably practicable, and with respect to disclosures pursuant
to the foregoing subsection (i), the Receiving Party shall use reasonable
efforts, and reasonably cooperate with the Disclosing Party, to secure
confidential treatment and if available, an appropriate protective order and
only furnish that Confidential Information that it is advised by counsel that it
is legally required to furnish. For the avoidance of doubt, Merck may, without
Company’s consent, disclose Confidential Information to clinical trial sites and
clinical trial investigators performing the Study, the data safety monitoring
and advisory board relating to the Study, and Regulatory Authorities working
with Merck on the Study, in each case to the extent necessary for the
performance of the Study and provided that such Persons (other than governmental
entities), and those Persons to whom Confidential Information is disclosed
pursuant to subsections (ii) through (iii) in this Section 9.1, are bound by an
obligation of confidentiality at least as stringent as the obligations contained
herein.

9.2.    Inventions. For clarity: (i) Inventions that constitute Confidential
Information and are jointly owned by the Parties, shall constitute the
Confidential Information of both Parties and each Party shall have the right to
use and disclose such Confidential Information consistent with Articles 10, 11
and 12; and (ii) Inventions that constitute Confidential Information and are
solely owned by one Party shall constitute the Confidential Information of that
Party and each Party shall have the right to use and disclose such Confidential
Information consistent with Articles 10, 11 and 12 and Section 9.1.

9.3.    Personal Identifiable Data. All Confidential Information containing
personal identifiable data shall be handled by and on behalf of each Party in
accordance with all Applicable Laws and such Party’s policies, rules and
procedures with respect to data protection and privacy applicable to such data.

10.
Intellectual Property.

10.1.    Joint Ownership and Prosecution.
10.1.1.     All rights to all Inventions relating to, or covering, the combined
use of the Company Compound and the Merck Compound that are not Merck Inventions
or Company Inventions (each a “Jointly Owned Invention”) shall be owned jointly
by Company and Merck, with each Party holding an undivided one-half interest
therein. Merck hereby assigns, and shall cause its Affiliates, Subcontractors
and sublicensees to assign, to Company an undivided one-half in, to and under
the Jointly Owned Inventions that are invented or created by or on behalf of
Merck, any of its Affiliates or by Persons having an obligation to assign such
rights to Merck. Company hereby assigns, and shall cause its Affiliates,
Subcontractors and sublicensees to assign, to Merck an undivided one-half
interest in, to and under any Jointly Owned Inventions that are invented or
created by or on behalf of Company or by Persons having an obligation to assign
such rights to Company. For those countries where a specific license is required
for a joint owner of a Jointly Owned Invention to practice such Jointly Owned
Invention in such countries: (i) Merck hereby grants, and shall cause its
applicable Affiliates to grant, to Company a perpetual, irrevocable,
non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and
sublicensable, under Merck’s right, title and interest in and to all Jointly
Owned Inventions, and all related Joint Patents, to use such Inventions and
intellectual property in accordance with the terms of this Agreement; and (ii)
Company hereby grants, and shall cause its applicable Affiliates to grant, to
Merck a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully
paid-up license, transferable and sublicensable, under Company’s right, title
and interest in and to all Jointly Owned Inventions, and all related Joint
Patents, to use such Inventions and intellectual property in accordance with the
terms of this Agreement. For clarity, the terms of this Agreement do not provide
Company or Merck with any rights, title or interest or any license to the other
Party’s intellectual property (other than intellectual property with respect to
the Jointly Owned Inventions) except to the extent necessary to conduct the
Study, subject to the terms in, and to the extent expressly provided, under this
Agreement, including as set forth in Section 10.5.
10.1.2.    Each Party shall have the right to freely exploit each Jointly Owned
Invention both within and outside the scope of the Study, without accounting to
or any other obligation to the other Party; provided, however, that [ * ] and[ *
], provided, further, that the foregoing prohibitions shall not apply to
publicly available information that is not claimed in a patent or patent
application filed pursuant to this Agreement so long as such information was not
made publicly available in violation of the terms of this Agreement.
10.1.3.    Promptly following the Effective Date, but in any event as soon as
practicable after the discovery of a Jointly Owned Invention, patent
representatives of each of the Parties shall meet (in person or by telephone) to
discuss the patenting strategy for any Jointly Owned Inventions that may arise.
In particular, the Parties shall discuss which Party (such Party, the
“Responsible Party”) will file, and prosecute a patent application (including
any provisional, substitution, divisional, continuation, continuation in part,
reissue, renewal, reexamination, extension, supplementary protection certificate
and the like) in respect of any Jointly Owned Invention (each, a “Joint Patent
Application”), and maintain any patent which issues therefrom (each, a “Joint
Patent”) and unless otherwise agreed by the Parties, the Responsible Party shall
appoint counsel that is mutually acceptable to the Parties. In any event, the
Parties shall consult and reasonably cooperate with one another in the
preparation, filing, prosecution (including prosecution strategy) and
maintenance of such patent application and shall equally share the expenses
associated with the Joint Patent Applications and any corresponding Joint
Patents. In the event that one Party (the “Filing Party”) wishes the Responsible
Party to file a patent application for a Jointly Owned Invention and the other
Party (the “Non-Filing Party”) does not want the Responsible Party to file a
patent application for such Jointly Owned Invention or does not want the
Responsible Party to file in a particular country, the Non-Filing Party shall
execute in a timely manner and at the Filing Party’s reasonable expense an
assignment of such Jointly Owned Invention, and any intellectual property rights
with respect thereto, to the Filing Party (in such country or all countries, as
applicable) and any additional documents as may be reasonably necessary to allow
the Filing Party to file and prosecute such patent application. If a Party (the
“Opting-out Party”) wishes the Responsible Party to discontinue the prosecution
and maintenance (or sharing in the costs with respect thereto) of a Joint Patent
Application or Joint Patent (in one or more countries), the other Party, at its
sole option (the “Continuing Party”), may continue such prosecution and
maintenance. In such event, the Opting-out Party shall execute in a timely
manner and at the Continuing Party’s reasonable expense an assignment of such
Joint Patent Application or Joint Patent to the Continuing Party (in such
country or all countries, as applicable) and any additional documents as may be
necessary to allow the Continuing Party to prosecute and maintain such Joint
Patent Application or Joint Patent. Any Jointly Owned Invention, Joint Patent
Application or Joint Patent so assigned shall thereafter be owned solely by the
Continuing Party or Filing Party (as applicable), shall no longer be considered
jointly owned, and the Non-Filing Party or Opting-out Party (as applicable)
shall have no right to practice under such Joint Patent Application or Joint
Patent in the applicable country or countries.
10.1.4.    Except as expressly provided in Section 10.1.3 and in furtherance and
not in limitation of Section 9.1, each Party agrees to file no patent
application based on the other Party’s Confidential Information, and to give no
assistance to any Third Party for such application, without the other Party’s
prior written authorization.
10.1.5.    Patent Enforcement.
(a)Each Party will promptly notify the other Party in writing of any actual or
threatened infringement, misappropriation, other violation, or challenge to the
validity, scope or enforceability, by a Third Party of any Joint Patents or
Jointly Owned Inventions of which it becomes aware ("Third Party Infringement").
(b)Company shall have the first right (but not the obligation) to initiate legal
action to enforce the Joint Patents and Jointly Owned Inventions against Third
Party Infringement by any Third Party, where such Third Party Infringement
results from the development or sale of a product that includes a Company Class
Compound but not a PD-1 Antagonist or to defend any declaratory judgment action
relating thereto, at its sole expense. In the event that Company fails to
initiate or defend such action within ninety (90) days after being first
notified of such Third Party Infringement, or thirty (30) days before the
expiration date for filing such action or responding, whichever comes first,
Merck shall have the right to do so at its sole expense.
(c)Merck shall have the first right (but not the obligation) to initiate legal
action to enforce all Joint Patents and Jointly Owned Inventions against Third
Party Infringement, where such Third Party Infringement results from the
development or sale of a product that includes a PD-1 Antagonist but not a
Company Class Compound or to defend any declaratory judgment action relating
thereto, at its sole expense. In the event that Merck fails to initiate or
defend such action within ninety (90) days after being first notified of such
Third Party Infringement, or thirty (30) days before the expiration date for
filing such action or responding, whichever comes first, Company shall have the
right to do so at its sole expense.
(d)The Parties shall cooperate in good faith to coordinate legal action to
enforce all Joint Patents and Jointly Owned Inventions against Third Party
Infringement by any Third Party where such Third Party Infringement results from
the development or sale of a product that includes both a PD-1 Antagonist and a
Company Class Compound or to defend any declaratory judgment action relating
thereto, and shall share the costs and expenses of such litigation equally.
Notwithstanding the foregoing, either Party shall have the right to opt-out of
controlling any such legal action by providing written notice to the other Party
within (1) ninety (90) days after being first noticed of such Third Party
Infringement, (2) thirty (30) days before the expiration date for filing such
action, (3) thirty (30) days before the expiration date for filing an answer to
a complaint in a declaratory judgment action, or (4) fifteen (15) days (A) after
receipt of an application to the U.S. Food & Drug Administration under Section
351(k) of the U.S. Public Health Services Act (42 USC 262(k)), or to a similar
agency under any similar provisions in another country, seeking approval of a
biosimilar or interchangeable biological product of the Merck Compound or (B)
before the expiration date for filing an action in connection with a
certification filed pursuant to 21 U.S.C. §355(b)(2)(A)(iv) or
355(j)(2)(A)(vii)(IV) or under any similar provisions in another country,
whichever comes first. In such event, the Parties shall comply with Section
10.1.6; provided that, any damages or other monetary awards recovered shall be
shared as follows: (i) the amount of such recovery actually received by the
Party controlling such action shall be first applied to the out-of-pocket costs
of each Party in connection with such action; and then (ii) any remaining
proceeds shall be shared equally by the Parties.
10.1.6.    If one Party brings any prosecution or enforcement action or
proceeding against a Third Party with respect to any Joint Patent, upon such
Party’s reasonable request, the second Party agrees to be joined as a party
plaintiff where necessary for standing purposes and to give the first Party
reasonable assistance and authority to file and prosecute the suit upon the
first Party’s request at the first Party’s sole cost and expense. The Party that
does not bring such action or proceeding shall have the right to be represented
by counsel (which shall act in an advisory capacity only, except for matters
solely directed to such Party) of its own choice and at its own expense in such
an action or proceeding (unless the other Party has requested such Party to join
such action in accordance with the previous sentence in this Section 10.1.6).
The costs and expenses of the Party bringing suit under this Section 10.1.6
shall be borne by such Party, and any damages or other monetary awards recovered
shall be shared as follows: (i) the amount of such recovery actually received by
the Party controlling such action shall be first applied to the out-of-pocket
costs of each Party in connection with such action; and then (ii) any remaining
proceeds shall be divided evenly between Company and Merck. A settlement or
consent judgment or other voluntary final disposition of a suit under this
Section 10.1.6 may not be entered into without the prior written consent of the
Party not bringing the suit.

10.2.    Inventions Owned by Company. Notwithstanding anything to the contrary
contained in Section 10.1, the Parties agree that all rights to Inventions
relating solely to, or covering solely, the Company Compound or a Company Class
Compound are the exclusive property of Company (“Company Inventions”). Company
shall have the sole right but not the obligation to file, prosecute, maintain
and with respect to issued patents, enforce (including any proceedings relating
to reissues, reexaminations, interferences, oppositions, post-grant reviews or
similar proceedings and requests for patent extensions) in its own or its
designee’s name relevant patent applications and to own resultant patent rights
for any Company Invention. For the avoidance of doubt, any Invention generically
encompassing the Company Compound or another Company Class Compound (and not the
Merck Compound or any Invention generically encompassing the Merck Compound)
within its scope, even where the Company Compound or Company Class Compound is
not disclosed per se, is a Company Invention. Merck hereby assigns, and shall
cause its Affiliates to assign, its right, title and interest to any and all
Company Inventions to Company.

10.3.    Inventions Owned by Merck. Notwithstanding anything to the contrary
contained in Section 10.1, the Parties agree that all rights to Inventions
relating solely to, or covering solely, the Merck Compound or a PD-1 Antagonist
are the exclusive property of Merck (“Merck Inventions”). Merck shall have the
sole right, but not the obligation, to file, prosecute, maintain and with
respect to issued patents, enforce (including any proceedings relating to
reissues, reexaminations, interferences, oppositions, post-grant reviews or
similar proceedings and requests for patent extensions) in its own or its
designee’s name relevant patent applications and to own resultant patent rights
for any Merck Invention. For the avoidance of doubt, any Invention generically
encompassing the Merck Compound or another PD-1 Antagonist (and not the Company
Compound or any Invention generically encompassing the Company Compound) within
its scope, even where the Merck Compound or other PD-1 Antagonist is not
disclosed per se, is a Merck Invention. Company hereby assigns, and shall cause
its Affiliates to assign, its right, title and interest to any and all Merck
Inventions to Merck.

10.4.    Separation of Patent Rights. In order to more efficiently enable the
filing, prosecution, maintenance and enforcement of patents with respect to the
Merck Inventions, Company Inventions and Jointly Owned Inventions, the Parties
shall use good faith efforts to separate any Merck Inventions, Company
Inventions and Jointly Owned Inventions into separate patent applications to the
extent possible and without adversely impacting such filing, prosecution,
maintenance and enforcement.

10.5.    Mutual Freedom to Operate for Combination Inventions.
10.5.1.    Company License to Merck. Company hereby grants, and shall cause its
Affiliates to grant, to Merck a non-exclusive, worldwide, royalty-free, fully
paid-up, transferable (subject to Section 18) and sublicensable (subject to
Section 10.5.3), license to any and all issued patents and patent applications
Controlled by Company that (a) has a priority claim that is earlier than the
initiation of the Study (i.e., first dosing of the first patient in the Study)
and (b) claims or covers the Combination (the “Company Background Patents”),
solely for the purpose of conducting the Study during the Term of this Agreement
in accordance with the terms hereof but for no other purpose.
10.5.2.    Merck License to Company. Merck hereby grants, and shall cause its
Affiliates to grant, to Company a non-exclusive, worldwide, royalty-free, fully
paid-up, transferable (subject to Section 18) and sublicensable (subject to
Section 10.5.3), license to any and all issued patents and patent applications
Controlled by Merck that (a) has a priority claim that is earlier than the
initiation of the Study (i.e., first dosing of the first patient in the Study)
and (b) claims or covers the Combination (the “Merck Background Patents”),
solely for the purpose of conducting the Study during the Term of this Agreement
in accordance with the terms hereof but for no other purpose.
10.5.3.    Sublicensing. Merck shall have the right to grant sublicenses of the
license granted to it pursuant to Section 10.5.1 to its Affiliates and to the
extent expressly permitted hereunder, to Third Parties, solely as necessary to
assist Merck with fulfilling its obligations hereunder. Each Third Party
sublicense granted hereunder shall be granted pursuant to a written agreement,
which agreement shall bind the applicable sublicensee to obligations that are
consistent with a Party’s obligations under this Agreement. Notwithstanding any
sublicensing of its rights hereunder, Merck shall remain solely and fully liable
for its sublicensees’ compliance with the terms hereof and granting a sublicense
shall not relieve Merck of its obligations hereunder. Upon Company’s request,
Merck shall promptly provide Company with a list of the Persons granted a
sublicense hereunder at the time of such request.
10.5.4.    No Other Rights. For clarity, the terms of this Section 10.5 do not
provide Merck or Company with any rights, title or interest or any license to
the other Party’s intellectual property rights that do not have a priority claim
that is earlier than the initiation of the Study or do not claim the Combination
(i.e., intellectual property owned or licensed by either Party which does not
constitute an Invention and does not claim or cover the Combination) except as
necessary to conduct the Study.
10.5.5.    Termination. Any and all licenses granted under this Section 10.5
shall terminate upon the earlier of (i) the termination of this Agreement and
(ii) the completion of the Study or any Phase III Study conducted by the Parties
pursuant to and subject to the Parties’ agreement under Section 3.14.

11.
Reprints; Rights of Cross-Reference.

Consistent with applicable copyright and other laws, each Party may use, refer
to, and disseminate reprints of scientific, medical and other published articles
and materials from journals, conferences and/or symposia relating to the Study
that disclose the name of a Party, provided, however, that such use does not
constitute an endorsement of any commercial product or service by the other
Party.

12.
Publications; Press Releases.

12.1.    Clinical Trial Registry. Merck shall register the Study with the
Clinical Trials Registry located at www.clinicaltrials.gov and is committed to
timely publication of the results following Study Completion, after taking
appropriate action to secure, and providing Company an opportunity to take
action to secure, intellectual property rights (if any) arising from the Study.
The publication of the results of the Study will be in accordance with the
Protocol.

12.2.    Publication. Each Party shall use reasonable efforts to publish or
present scientific papers dealing with the Study in accordance with accepted
scientific practice. The Parties agree that prior to submission of the results
of the Study for publication or presentation or any other dissemination of such
results including oral dissemination, the publishing Party shall invite the
other to comment on the content of the material to be published, presented, or
otherwise disseminated according to the following procedure:
12.2.1.    At least forty-five (45) days prior to submission for publication of
any paper, letter or any other publication, or thirty (30) days prior to
submission for presentation of any abstract, poster, talk or any other
presentation, the publishing Party shall provide to the other Party the full
details (including, for clarity, a full and complete copy) of the proposed
publication, presentation, or dissemination in an electronic version (cd-rom or
email attachment). Upon written request from the other Party, the publishing
Party agrees not to submit data for publication/presentation/dissemination for
an additional ninety (90) days in order to allow for actions to be taken to
preserve rights for patent protection.
12.2.2.    The publishing Party shall give reasonable consideration to any
request by the other Party made within the periods mentioned in Section 12.2.1
to modify the publication and the Parties shall work in good faith and in a
timely manner to resolve any issue regarding the content for publication.
12.2.3.    The publishing Party shall remove all Confidential Information of the
other Party before finalizing the publication.
12.2.4.    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.

12.3.    Press Releases. The Company may issue a press release regarding the
execution of this Agreement in the mutually agreed form set forth on Appendix C
and on the date mutually agreed by the Parties, which date shall not be later
than four (4) Business Days after the Effective Date. Thereafter, unless
otherwise required by Applicable Law, neither Party shall make any public
announcement concerning this Agreement without the prior written consent of the
other Party and the Parties will mutually agree on the content and timing of any
press releases with respect to the Agreement or the Study. To the extent a Party
desires to make such public announcement, such Party shall provide the other
Party with a draft thereof for review and comment at least seven (7) Business
Days prior to the date on which such Party proposes to make the public
announcement.

13.
Representations and Warranties; Disclaimers.

13.1.    Due Authorization. Each of Company and Merck represents and warrants to
the other that: (i) it has the corporate power and authority and the legal right
to enter into this Agreement and perform its obligations hereunder; (ii) it has
taken all necessary corporate action on its part required to authorize the
execution and delivery of this Agreement and the performance of its obligations
hereunder; and (iii) this Agreement has been duly executed and delivered on
behalf of such Party and constitutes a legal, valid and binding obligation of
such Party that is enforceable against it in accordance with its terms.

13.2.    Compounds.
13.2.1.    Company Compound. Company hereby represents and warrants to Company
that, to its knowledge, as of the Effective Date, Company has the full power,
right and authority to grant all of the licenses granted hereunder with respect
to the Company Background Patents.
13.2.2.    Merck Compound. Merck hereby represents and warrants to Company that,
to its knowledge, as of the Effective Date, Merck has full power and authority
to grant all of the licenses granted hereunder with respect to Merck Background
Patents.

13.3.    Results. The Parties do not undertake that the Study shall lead to any
particular result, nor is the success of the Study guaranteed. Neither Party
shall be liable for any use that the other Party may make of the Clinical Data
nor for advice or information given in connection therewith.

13.4.    Anti-Corruption.
13.4.1.    By signing this Agreement, each Party agrees to conduct its
obligations contemplated herein in a manner that is consistent in all material
respects with all Applicable Law, including the Stark Act, Anti-Kickback
Statute, Sunshine Act, and the U.S. Foreign Corrupt Practices Act, and its
compliance policies, as applicable, which may be reviewed by the other Party
from time to time.
13.4.2.    Specifically, each Party represents and warrants that it has not, and
covenants that it shall not, authorize its Affiliates, and its and its
Affiliates’ directors, employees, officers, and anyone acting on its behalf, in
connection with the performance of this Agreement, directly or indirectly, to
make, promise, authorize, ratify or offer to make, or take any action in
furtherance of, any payment or transfer of anything of value for the purpose of
influencing, inducing or rewarding any act, omission or decision to secure an
improper advantage; or improperly assisting it in obtaining or retaining
business for it or the other Party, or in any way with the purpose or effect of
public or commercial bribery.
13.4.3.    Neither Party shall contact, or otherwise knowingly meet with, any
Government Official for the purpose of discussing activities arising out of or
in connection with this Agreement, without the prior written approval of the
other Party, except where such meeting is consistent with the purpose and terms
of this Agreement and in compliance with Applicable Law.
13.4.4.    Each Party represents and warrants that it (i) is not excluded,
debarred, suspended, proposed for suspension or debarment, in Violation or
otherwise ineligible to participate in government programs; and (ii) to its
knowledge, has not employed or subcontracted with any Person for the performance
of the Study who is excluded, debarred, suspended, proposed for suspension or
debarment, or is in Violation or otherwise ineligible to participate in
government programs.
13.4.5.    Each Party represents and warrants that, except as disclosed to the
other in writing prior to the Effective Date, such Party: (1) does not have any
interest that directly or indirectly prevents its lawful performance of this
Agreement; (2) shall maintain arm’s length relations with all Third Parties with
which it deals for or on behalf of the other in performance of, this Agreement;
and (3) has provided complete and accurate information and documentation to the
other Party, the other Party’s Affiliates and its and their personnel in the
course of any due diligence conducted by the other Party for this Agreement,
with respect to any officers, employees, owners or Persons directly or
indirectly retained by such Party in relation to the performance of this
Agreement who are Government Officials or relatives of Government Officials.
Upon a Party’s reasonable request and to the extent necessary to comply with
Applicable Law, the other Party shall make all further disclosures to the other
Party as are necessary to ensure the information provided remains complete and
accurate throughout the Term, and any all such disclosures shall be subject to
the confidentiality and non-use provisions set forth herein. Subject to the
foregoing, each Party agrees that it shall not hire or retain any Government
Official to assist in its performance of this Agreement, with the sole exception
of conduct of or participation in clinical trials under this Agreement, provided
that such hiring or retention shall be subject to the completion by the hiring
or retaining Party of a satisfactory anti-corruption and bribery (e.g., FCPA)
due diligence review of such Government Official.
13.4.6.    Each Party shall have the right during the Term, and for a period of
two (2) years following termination of this Agreement, upon reasonable prior
notice and solely during business hours to conduct an investigation and audit of
the other Party’s, its Affiliates and its Sublicensee’s activities, books and
records, to the extent they relate to that other Party’s performance under this
Agreement, to verify compliance with the terms of this Section 13.4. Such other
Party shall cooperate fully with such investigation or audit, the scope, method,
nature and duration of which shall be at the sole reasonable discretion of the
Party requesting such audit. No more than one such investigation and audit shall
be conducted of each of (a) a Party and its Affiliates, (b) such Party’s
sublicensees, and (c) such Party’s Subcontractors during each calendar year,
unless it is determined during any such investigation or audit that the audited
Person failed to comply with the terms hereof (and in such event, an additional
investigation and audit of such Person conducted in accordance with this Section
shall be permitted during such calendar year).
13.4.7.    Each Party shall use commercially reasonable efforts to ensure that
all transactions under the Agreement are 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. Each Party further represents, warrants and covenants that
all books, records, invoices and other documents relating to payments and
expenses under this Agreement are and shall be materially complete and accurate
and reflect in reasonable detail the character and amount of transactions and
expenditures. Each Party shall maintain a system of internal accounting controls
reasonably designed to ensure that no off-the-books or similar funds or accounts
will be maintained or used in connection with this Agreement.
13.4.8.    Each Party agrees that in the event that the other Party reasonably
believes in good faith that there has been a violation of any provision of
Section 13.4, such other Party may make full disclosure of such belief and
related information needed to support such belief at any time and for any reason
to any competent government bodies and agencies to the extent required under
Applicable Law; provided that the disclosing Party shall provide the other Party
with prior written notice (or if prior written notice is not reasonably
practicable, written notice as soon as reasonably practicable) of the disclosure
to the extent permitted by Applicable Law.
13.4.9.    Each Party shall comply with its own business ethics and/or
compliance policies, as applicable, and any corporate integrity agreement (if
applicable) to which it is subject, and shall conduct its Study-related
activities in accordance in all material respects with Applicable Law. Each
Party shall ensure that all of its employees involved in performing its
obligations under this Agreement are made specifically aware of the compliance
requirements under this Section 13.4 to the extent applicable in light of such
employees’ individual responsibilities.
13.4.10.    Each Party shall have the right to terminate this Agreement
immediately upon violation of this Section 13.4 in accordance with, and subject
to, Section 6.7.

13.5.    DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED HEREIN, MERCK MAKES NO
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE MERCK COMPOUND, AND COMPANY
MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE COMPANY
COMPOUND. EACH PARTY HEREBY ACKNOWLEDGES AND AGREES THAT THE OTHER PARTY’S
COMPOUND IS EXPERIMENTAL IN NATURE AND MAY HAVE UNKNOWN CHARACTERISTICS.

14.
Insurance; Indemnification; Limitation of Liability.

14.1.    Insurance. Each Party warrants that it maintains a policy or program of
insurance or self-insurance at levels sufficient to support the indemnification
obligations assumed herein. Upon request, a Party shall provide evidence of such
insurance.

14.2.    Indemnification.
14.2.1.    Indemnification by Merck. Merck agrees to defend, indemnify and hold
harmless Company, its Affiliates, and its and their employees, directors,
subcontractors and agents from and against any loss, damage, reasonable costs
and expenses (including reasonable attorneys’ fees and expenses) incurred in
connection with any claim, proceeding, or investigation by a Third Party (a
“Liability”) to the extent such Liability arises out of this Agreement or the
Study, except to the extent that such Liability was caused by or arose from (i)
gross negligence or willful misconduct on the part of Company (or any of its
Affiliates, or its and their employees, directors, subcontractors, sublicensees
or agents),(ii) a breach on the part of Company of any of its representations
and warranties or any other covenants or obligations of Company under this
Agreement, or (iii) a breach of Applicable Law by Company.
14.2.2.    Indemnification by Company. Company agrees to defend, indemnify and
hold harmless Merck, its Affiliates, and its and their employees, directors,
subcontractors and agents from and against any Liability to the extent such
Liability arises out of this Agreement or the Study and was caused by or arose
from (i) gross negligence or willful misconduct on the part of Company (or any
of its Affiliates, or its and their employees, directors, subcontractors,
sublicensees or agents), (ii) a breach on the part of Company of any of its
representations and warranties or any other covenants or obligations of Company
under this Agreement, or (iii) a breach of Applicable Law by Company.
14.2.3.    Procedure. The obligations of Merck and Company under this Section
14.2 are conditioned upon the delivery of written notice (the “Indemnifying
Notice”) to Merck or Company, as the case might be, of any potential Liability
within a reasonable time after a Party becomes aware of such potential
Liability; provided that, delay or failure to provide such notice shall not
relieve the indemnifying Party of its obligation under this Section 14.2, except
to the extent the indemnifying Party is materially prejudiced by such delay or
failure. The indemnifying Party will have the right to assume the defense of any
suit or claim related to the Liability (using counsel reasonably satisfactory to
the indemnified Party) if it has assumed responsibility for the suit or claim in
writing within fifteen (15) days following receipt of the Indemnifying Notice,
but no later than five (5) days before the date on which any response to a
complaint or summons is due; provided that the indemnified Party may assume the
responsibility for such defense to the extent the indemnifying Party does not do
so within the required time period. The indemnified Party may participate in
(but not control) the defense thereof at its sole cost and expense, unless the
indemnifying Party fails to assume such defense, in which case, the indemnifying
Party shall be responsible for such costs and expenses of the indemnified Party.
If the indemnifying Party assumes responsibility for the defense of any suit or
action, the indemnified Party shall, and shall cause the other indemnitees to,
reasonably cooperate in the prosecution and defense thereof upon the
indemnifying party’s request and at the indemnifying Party’s cost and expense.
The Party controlling such defense (the “Defending Party”) shall keep the other
Party (the “Other Party”) advised of the status of such action, suit, proceeding
or claim and the defense thereof and shall reasonably consider recommendations
made by the Other Party with respect thereto. The Defending Party shall not
agree to any settlement of such action, suit, proceeding or claim without the
prior written consent of the Other Party, which shall not be unreasonably
withheld. The Defending Party, but solely to the extent the Defending Party is
also the indemnifying Party, shall not agree to any settlement of such action,
suit, proceeding or claim or consent to any judgment in respect thereof that
does not include a complete and unconditional release of the Other Party from
all liability with respect thereto or that imposes any liability or obligation
on the Other Party without the prior written consent of the Other Party.
14.2.4.    Study Subjects. Company shall not offer compensation on behalf of
Merck to any Study subject or bind Merck to any indemnification obligations in
favor of any Study subject. Merck shall not offer compensation on behalf of
Company to any Study subject or bind Company to any indemnification obligations
in favor of any Study subject.

14.3.    LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS
AFFILIATES OR SUBCONTRACTORS) BE LIABLE TO THE OTHER PARTY UNDER ANY THEORY FOR,
NOR SHALL ANY INDEMNIFIED PARTY HAVE THE RIGHT TO RECOVER, ANY SPECIAL,
INDIRECT, INCIDENTAL, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES OR ANY PUNITIVE
DAMAGES OR ANY LOST PROFIT, LOST SALE OR LOST OPPORTUNITY DAMAGES (WHETHER SUCH
CLAIMED DAMAGES ARE DIRECT OR INDIRECT), WHETHER ARISING DIRECTLY OR INDIRECTLY
OUT OF (X) THE MANUFACTURE OR USE OF ANY COMPOUND SUPPLIED HEREUNDER OR (Y) ANY
BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT OR ANY
REPRESENTATION, WARRANTY OR COVENANT CONTAINED IN OR MADE PURSUANT TO THIS
AGREEMENT, EXCEPT THAT SUCH LIMITATION SHALL NOT APPLY TO DAMAGES PAID OR
PAYABLE TO A THIRD PARTY BY AN INDEMNIFIED PARTY FOR WHICH THE INDEMNIFIED PARTY
IS ENTITLED TO INDEMNIFICATION HEREUNDER OR WITH RESPECT TO DAMAGES ARISING OUT
OF OR RELATED TO A PARTY’S BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT WITH
RESPECT TO USE, DISCLOSURE, LICENSE, ASSIGNMENT OR OTHER TRANSFER OF CLINICAL
DATA, CONFIDENTIAL INFORMATION, JOINTLY OWNED INVENTIONS AND SAMPLE TESTING
RESULTS.

15.
Use of Name.

Except as otherwise expressly provided herein, neither Party shall have any
right, express or implied, to use in any manner the name or other designation of
the other Party or any other trade name, trademark or logo of the other Party
for any purpose in connection with the performance of this Agreement without the
other Party’s prior written consent.

16.
Force Majeure.

If, in the performance of this Agreement, one of the Parties is prevented,
hindered or delayed by reason of any cause beyond such Party’s reasonable
control (e.g., war, riots, fire, strike, acts of terror, governmental laws),
such Party shall be excused from performance to the extent that it is
necessarily prevented, hindered or delayed (“Force Majeure”). The non-performing
Party shall notify the other Party of such Force Majeure within ten (10) days
after such occurrence by giving written notice to the other Party stating the
nature of the event, its anticipated duration, and any action being taken to
avoid or minimize its effect. The suspension of performance will be of no
greater scope and no longer duration than is necessary and the non-performing
Party shall use commercially reasonable efforts to remedy its inability to
perform.

17.
Entire Agreement; Amendment; Waiver.

This Agreement, together with the Appendices and Schedules hereto and the
Related Agreements, constitutes the sole, full and complete agreement by and
between the Parties with respect to the subject matter of this Agreement, and
all prior agreements, understandings, promises and representations, whether
written or oral, with respect thereto are superseded by this Agreement. In the
event of a conflict between a Related Agreement and this Agreement, the terms of
this Agreement shall control. No amendments, changes, additions, deletions or
modifications to or of this Agreement shall be valid unless reduced to writing
and signed by the Parties hereto. Any term or condition of this Agreement may be
waived at any time by the Party that is entitled to the benefit thereof, but no
such waiver shall be effective unless set forth in a written instrument duly
executed by or on behalf of the Party waiving such term or condition. The waiver
by either Party of any right hereunder or of the failure to perform or of a
breach by the other Party shall not be deemed a waiver of any other right
hereunder or of any other breach or failure by said other Party whether of a
similar nature or otherwise.

18.
Assignment and Affiliates.

Neither Party shall assign or transfer this Agreement without the prior written
consent of the other Party; provided, however, that (a) either Party may assign
all or any part of this Agreement to one or more of its Affiliates without the
other Party’s consent, and any and all rights and obligations of either Party
may be exercised or performed by its Affiliates, provided that such Affiliates
agree to be bound by this Agreement and (b) either Party may assign its rights
and obligations under this Agreement to a Third Party in connection with a sale
of all or substantially all of its business or assets to which this Agreement
relates (including by sale of assets, merger, or otherwise; provided that such
Third Parties agree in writing to be bound by this Agreement). Any assignment in
violation of this Section 18 shall be void ab initio.

19.
Invalid Provision.

If any provision of this Agreement is held to be illegal, invalid or
unenforceable, the remaining provisions shall remain in full force and effect
and will not be affected by the illegal, invalid or unenforceable provision. In
lieu of the illegal, invalid or unenforceable provision, the Parties shall
negotiate in good faith to agree upon a reasonable provision that is legal,
valid and enforceable to carry out as nearly as practicable the original
intention of the entire Agreement.

20.
No Additional Obligations.

Company and Merck have no obligation to renew this Agreement or apply this
Agreement to any clinical trial other than the Study. Neither Party is under any
obligation to enter into another type of agreement at this time or in the
future.

21.
Governing Law; Dispute Resolution.

21.1.    The Parties shall attempt in good faith to settle all disputes arising
out of or in connection with this Agreement in an amicable manner. Any claim,
dispute or controversy arising out of or relating to this Agreement, including
the breach, termination or validity hereof or thereof (each, a “Dispute”), shall
be governed by and construed in accordance with the substantive laws of the
State of New York, without giving effect to its choice of law principles.
21.2.    Nothing contained in this Agreement shall deny either Party the right
to seek injunctive or other equitable relief from a court of competent
jurisdiction in the context of a bona fide emergency or prospective irreparable
harm, and such an action may be filed or maintained notwithstanding any ongoing
discussions between the Parties.

22.
Notices.

All notices or other communications that are required or permitted hereunder
shall be in writing and delivered personally, sent by facsimile (and promptly
confirmed by personal delivery or overnight courier), or sent by
internationally-recognized overnight courier addressed as follows:
If to Company, to:

Array BioPharma, Inc.
3200 Walnut Street Boulder, CO 80301
Attention: Chief Operating Officer

If to Merck, to:

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Attention: Director
Facsimile: +31 23 514 8677

With copies (which shall not constitute notice) to:

Merck Sharp & Dohme Corp.
One Merck Drive
PO Box 100
Whitehouse Station, NJ 08889-0100
Attention: Office of Secretary

Merck Sharp & Dohme Corp.
351 North Sumneytown Pike
Mailstop UG4CD-16
North Wales, PA 19454-2505
Attention: Senior Vice President, Research Science

Merck Sharp & Dohme Corp.
2000 Galloping Hill Road
Mailstop K-1-3045
Kenilworth, NJ 07033-1310
Attention: Assistant General Counsel, Corporate Transactions

23.
Relationship of the Parties.

The relationship between the Parties is and shall be that of independent
contractors, and does not and shall not constitute a partnership, joint venture,
agency or fiduciary relationship. Neither Party shall have the authority to make
any statements, representations or commitments of any kind, or take any actions,
that are binding on the other Party, except with the prior written consent of
the other Party to do so. All Persons employed by a Party will be the employees
of such Party and not of the other Party and all costs and obligations incurred
by reason of any such employment shall be for the account and expense of such
Party.

24.
Counterparts and Due Execution.

This Agreement and any amendment may be executed in any number of counterparts
(including by way of facsimile or electronic transmission), each of which shall
be deemed an original, but all of which together shall constitute one and the
same instrument, notwithstanding any electronic transmission, storage and
printing of copies of this Agreement from computers or printers. When executed
by the Parties, this Agreement shall constitute an original instrument,
notwithstanding any electronic transmission, storage and printing of copies of
this Agreement from computers or printers. For clarity, facsimile signatures and
signatures transmitted via PDF shall be treated as original signatures.

25.
Construction.

Except where the context otherwise requires, wherever used, the singular will
include the plural, the plural the singular, the use of any gender will be
applicable to all genders, and the word “or” is used in the inclusive sense
(and/or). Whenever this Agreement refers to a number of days, unless otherwise
specified, such number refers to calendar days. The captions of this Agreement
are for convenience of reference only and in no way define, describe, extend or
limit the scope or intent of this Agreement or the intent of any provision
contained in this Agreement. The term “including” as used herein shall be deemed
to be followed by the phrase “without limitation” or like expression. The term
“will” as used herein means shall. The terms “hereof”, “hereto”, “herein” and
“hereunder” and words of similar import when used in this Agreement refer to
this Agreement as a whole and no to any particular provision of this Agreement.
References to “Article,” “Section”, “Appendix” or “Schedule” are references to
the numbered sections of this Agreement and the appendices attached to this
Agreement, unless expressly stated otherwise. Except where the context otherwise
requires, references to this “Agreement” shall include the appendices attached
to this Agreement. The language of this Agreement shall be deemed to be the
language mutually chosen by the Parties and no rule of strict construction will
be applied against either Party hereto. The Section headings are for convenience
only and will not be deemed to affect in any way the language of the provisions
to which they refer.
[Remainder of page intentionally left blank.]

IN WITNESS WHEREOF, the respective representatives of the Parties have executed
this Agreement as of the Effective Date.
Array BioPharma, Inc.
By: _______________________________
___________________________________
Name
___________________________________
Title

Merck Sharp & Dohme B.V.
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Appendix A
PROTOCOL SYNOPSIS
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Appendix B

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Appendix C

PRESS RELEASE

See attached.

 
Array BioPharma Announces Strategic Collaboration with Merck
- Novel combinations of binimetinib (MEK inhibitor) and KEYTRUDA®
(pembrolizumab, anti-PD-1 therapy) to be studied in colorectal cancer patients
with microsatellite stable tumors -

BOULDER, Colo., May 8, 2017 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY)
announced today that it has entered into a clinical trial collaboration
agreement with Merck (known as MSD outside the United States and Canada) to
investigate the safety and efficacy of Array's MEK inhibitor, binimetinib, with
Merck's anti-PD-1 therapy, KEYTRUDA®(pembrolizumab), in metastatic colorectal
cancer patients with microsatellite stable tumors (MSS CRC).
The companies are entering into this collaboration based on the growing body of
preclinical and clinical evidence that the immune activity of an anti-PD-1
therapy, such as KEYTRUDA, can be enhanced when combined with a MEK inhibitor,
such as binimetinib.
"Array is excited to announce this partnership with Merck, an established leader
in the field of immuno-oncology," said Ron Squarer, Chief Executive
Officer, Array BioPharma. "Given the synergistic activity we have seen with our
MEK inhibitor when combined with anti-PD-1 therapy in preclinical models, and
based on emerging clinical data, we are optimistic that this combination holds
great potential for cancer patients."
Under the terms of the agreement, Array and Merck will collaborate on a clinical
trial to investigate the safety and efficacy of the combination of binimetinib
with KEYTRUDA, in MSS CRC patients. The trial is expected to establish a
recommended dose regimen of binimetinib and KEYTRUDA, as well as explore the
preliminary anti-tumor activity of several novel regimens. The study is expected
to begin in the second half of 2017. Results from this first study will be used
to determine optimal approaches to further clinical development of these
combinations.
The collaboration agreement is between Array BioPharma and Merck, through a
subsidiary. Under the agreement, the trial will be sponsored by Merck.
 Additional details of the collaboration were not disclosed.
About Colorectal Cancer
Worldwide, colorectal cancer is the third most common type of cancer in men and
the second most common in women, with approximately 1.4 million new diagnoses in
2012. Of these, nearly 750,000 were diagnosed in men, and 614,000 in women.
Globally in 2012, approximately 694,000 deaths were attributed to colorectal
cancer. In the U.S. alone, an estimated 135,430 patients will be diagnosed with
cancer of the colon or rectum in 2017, and approximately 50,000 are estimated to
die of their disease. There is wide variation in 5-year survival rates across
the globe, with 5-year survival expected to be around 65% in the developed world
and dropping to around 20% in some developing countries. The incidence of
microsatellite stability in colorectal tumors varies by stage, with nearly 80%
of early stage, resectable tumors and approximately 67% of advanced, metastatic
tumors exhibiting MSS.  
About Binimetinib
MEK is a key protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK).
Research has shown this pathway regulates several key cellular activities
including proliferation, differentiation, survival and angiogenesis.
Inappropriate activation of proteins in this pathway has been shown to occur in
many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a
late-stage small molecule MEK inhibitor which targets key enzymes in this
pathway.
Binimetinib is being studied in clinical trials in advanced cancer patients,
including the Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma and
the Phase 3 BEACON CRC trial in patients with BRAF V600E-mutant colorectal
cancer.
About Array BioPharma 
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery,
development and commercialization of targeted small molecule drugs to treat
patients afflicted with cancer.  Seven Array-owned or partnered drugs are
advancing in registration studies: binimetinib (MEK162), encorafenib (LGX818),
selumetinib (partnered with AstraZeneca), danoprevir (partnered with Roche),
larotrectinib (partnered with Loxo Oncology), tucatinib (partnered
with Cascadian Therapeutics) and ipatasertib (partnered with Genentech).
Array BioPharma Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements about the
timing of the commencement of the binimetinib and KEYTRUDA clinical trial;
expectations that events will occur that will result in greater value for Array;
and the potential for the results of the planned clinical trial to support
regulatory approval or the marketing success of the combination. These
statements involve significant risks and uncertainties, including those
discussed in our most recent annual report filed on Form 10-K, in our quarterly
reports filed on Form 10-Q, and in other reports filed by Array with
the Securities and Exchange Commission. Because these statements reflect our
current expectations concerning future events, our actual results could differ
materially from those anticipated in these forward-looking statements as a
result of many factors. These factors include, but are not limited to, the
determination by the FDA that results from clinical trials are not sufficient to
support registration or marketing approval of binimetinib and encorafenib; risks
associated with our dependence on third-parties to successfully conduct clinical
trials within and outside the United States; our ability to achieve and maintain
profitability and maintain sufficient cash resources; and our ability to attract
and retain experienced scientists and management. We are providing this
information as of April 8, 2017. We undertake no duty to update any
forward-looking statements to reflect the occurrence of events or circumstances
after the date of such statements or of anticipated or unanticipated events that
alter any assumptions underlying such statements.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ, USA

Schedule I
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