EXHIBIT 10.22

 

Information in this exhibit identified by [***] is confidential and has been
excluded pursuant to Item 601(b)(10)(iv) of Regulation S-K because it is both
not material and would likely cause competitive harm to the registrant if
publicly disclosed.

 

EXECUTION COPY

 

CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (RP-2)

 

This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (RP-2) (the “Agreement”)
is made and entered into effective as of the date signed by the last Party to
sign below (the “Effective Date”) by and between Replimune Inc., a corporation
organized under the laws of Delaware, having a place of business at 18 Commerce
Way, Woburn, MA 01801 (the “Recipient”) and Bristol-Myers Squibb Company, having
a place of business at 345 Park Avenue, New York, NY 10154 (“BMS”). The
Recipient and BMS are sometimes individually referred to in this Agreement as a
“Party” and collectively as the “Parties.”

 

PRELIMINARY STATEMENTS

 

A.                                    The Recipient and BMS are parties to that
certain Clinical Trial Collaboration and Supply Agreement, made and entered into
effective as of February 26, 2018 (the “RP-1 Agreement”), pursuant to which
Recipient is conducting, and BMS is supplying Opdivo® (nivolumab) for the
conduct of, a combined therapy clinical trial of Opdivo® (nivolumab) with
Recipient’s proprietary oncolytic virus known as RP-1.

 

B.                                    The Recipient desires to conduct, and BMS
desires to supply the BMS Study Drug (as defined below) for the conduct of, a
Combined Therapy Clinical Trial (as defined below) in accordance with the
Protocol (as defined below) therefor and in accordance with the terms of this
Agreement.

 

C.                                    The Parties desire to agree on various
terms and conditions to govern the Parties’ obligations in connection with the
performance of the Combined Therapy Clinical Trial.

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
promises and covenants contained herein, the Parties agree as follows:

 

ARTICLE 1
DEFINITIONS

 

The terms in this Agreement with initial letters capitalized, whether used in
the singular or the plural, shall have the meaning set forth below or, if not
listed below, the meaning designated in places throughout this Agreement.

 

“Adverse Event,” (“AE”) “Serious Adverse Event” (“SAE”) and “Serious Adverse
Drug Reaction” (“SADR”) shall have the meanings provided to such terms in the
International Conference on Harmonization (“ICH”) guideline for industry on
Clinical Safety Data Management (E2A, Definitions and Standards for Expedited
Reporting).

 

“Affiliates” means, with respect to a particular Party, an entity that, directly
or indirectly, through one or more intermediaries, controls, is controlled by or
is under common control with such Party, only for so long as such control
exists. As used in this definition, the term “controls” (with correlative
meanings for the terms “controlled by” or “under common control with”) means
(a) that an entity or company owns, directly or indirectly, more than fifty
percent (50%) of the voting stock of another entity, or (b) that an entity,
person or group otherwise has the actual ability to control and direct the
management of the entity, whether by contract or otherwise.

 

“Agreement” shall have the meaning set forth in the preamble to this Agreement,
and includes the Appendices attached hereto, the Supply and Quality
Documentation and any and all amendments of any of the foregoing hereafter
signed by the Parties with reference to this Agreement and made part hereof.

 

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“Applicable Law” means all applicable laws, rules and regulations (whether
federal, state or local) that may be in effect from time to time, including
current Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good
Manufacturing Practices (GMP).

 

“Arbitration Matter” means any disputed matter that relates to or arises out of
the validity, interpretation or construction of, or the compliance with or
breach of, this Agreement; provided that such disputed matter has been
considered, but not resolved, by the Executive Officers as set forth in
Section 13.3. For clarity, no Publication Dispute, or any matter requiring
mutual agreement of both Parties shall be an Arbitration Matter.

 

“BMS Class Drug” means (i) the BMS Study Drug and (ii) any other antibodies that
are designed to selectively bind to PD-1 or PD-L1.

 

“BMS Indemnitees” shall have the meaning set forth in Section 11.2.

 

“BMS Independent Patent Rights” means any Patent Rights Controlled by BMS (or
its Affiliates) (a) as of the Effective Date or (b) during the Term the subject
matter of which was conceived or first reduced to practice through activities
other than those performed pursuant to this Agreement, in each case of (a) or
(b) that Cover the use (whether alone or in combination with other agents),
manufacture, formulation or composition of matter of the BMS Study Drug.

 

“BMS Regulatory Documentation” means any Regulatory Documentation pertaining to
the BMS Study Drug that exists as of the Effective Date or that is created
during the Term through efforts outside this Agreement.

 

“BMS Study Data” shall have the meaning set forth in Section 8.2.

 

“BMS Study Drug” means BMS’s proprietary anti-PD-1 monoclonal antibody product
known as Opdivo® (nivolumab).

 

“BMS Study Invention” means any Invention that pertains to (a) the composition
of matter of any BMS Class Drug (and not any Recipient Class Drug), (b) method
of manufacture or formulation of any BMS Class Drug (and not any Recipient
Class Drug) as a Single Agent Compound, and/or (c) a method of use of any BMS
Class Drug (and not any Recipient Class Drug) as a monotherapy or as used with
other agents, antibodies or compounds (other than an Invention pertaining,
whether generically or specifically, to the composition of matter, method of
manufacture or formulation, or a method of use of both a BMS Class Drug and a
Recipient Class Drug).

 

“BMS Study Patent Rights” means any Patent Rights that Cover any BMS Study
Invention (and not a Recipient Study Invention or Combined Therapy Invention),
excluding BMS Independent Patent Rights and BMS Technology. For avoidance of
doubt, any Patent Rights that cover both (a) a BMS Study Invention and (b) any
other type of Invention is included within the Combined Therapy Patent Rights.

 

“BMS Technology” means all Technology Controlled by BMS (or its Affiliates) as
of the Effective Date or during the Term created through efforts outside of this
Agreement related to the BMS Study Drug or the Combined Therapy and necessary
for the conduct of the Combined Therapy Clinical Trial. For clarity, BMS
Technology does not include (a) Inventions, (b) Study Data, or (c) Combined
Therapy Clinical Trial Regulatory Documentation.

 

“Breaching Party” shall have the meaning set forth in Section 12.2(a).

 

“Business Day” means a day other than Saturday, Sunday or any day on which
commercial banks located in New York, NY are authorized or obligated by
Applicable Law to close.

 

“Clinical Hold” means that (a) the FDA has issued an order to a Party pursuant
to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an
ongoing clinical investigation of the Combined Therapy or such Party’s Single
Agent Compound in the United States or (b) a Regulatory Authority other than the
FDA has issued an equivalent order to that set forth in (a) in any other country
or group of countries.

 

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“Combined Therapy” means a therapy using the Recipient Study Drug and the BMS
Study Drug in combination, with or without another agent.

 

“Combined Therapy Clinical Trial” means the human clinical trial using the
Recipient Study Drug and the BMS Study Drug, which will be conducted under the
Recipient’s protocol (said, protocol, as it may be amended from time to time in
accordance with this Agreement, the “Protocol”) and is incorporated herein by
reference. A draft Protocol summary as of the Effective Date is attached as
Appendix A hereto. The draft Protocol shall be jointly agreed by the Parties as
set forth in Section 2.1(a).

 

“Combined Therapy IND” shall have the meaning set forth in Section 2.1(b).

 

“Combined Therapy Invention” means an Invention that is not a Recipient Study
Invention or a BMS Study Invention.

 

“Combined Therapy Patent Right(s)” means any Patent Rights that Cover any
Combined Therapy Invention or Combined Therapy Study Data. For clarity,
“Combined Therapy Patent Right(s)” do not include any BMS Independent Patent
Rights and Recipient Independent Patent Rights.

 

“Combined Therapy Clinical Trial Regulatory Documentation” means any Regulatory
Documentation to be submitted for the conduct of the Combined Therapy Clinical
Trial, but excluding (a) any Recipient Regulatory Documentation and (b) any BMS
Regulatory Documentation.

 

“Combined Therapy Study Data” shall have the meaning set forth in Section 8.2.

 

“Commercially Reasonable Efforts” means, with respect to a Party, the level of
effort and resources normally devoted by such Party to conduct a clinical trial
for a biopharmaceutical product or compound that is owned by it or to which it
has rights, which is of similar market potential, profit potential or strategic
value and at a similar stage in its development or product life based on
conditions then prevailing.

 

“Confidential Information” shall have the meaning set forth in Section 9.1(a).

 

“Control” or “Controlled” means, with respect to particular information or
intellectual property, that the applicable Party owns or has a license to such
information or intellectual property and has the ability to grant a right,
license or sublicense to the other Party as provided for herein without
violating the terms of any agreement or other arrangement with any Third Party.

 

“Cover” means, with respect to a Patent Right, that, but for rights granted to a
Person under such Patent Right, the practice by such Person of an invention
described in such Patent Right would infringe a claim included in such Patent
Right, or in the case of a Patent Right that is a patent application, would
infringe a claim in such patent application if it were to issue as a patent.
“Covered” or “Covering” shall have correlative meanings.

 

“CRO” means any Third Party contract research organization used to conduct the
Combined Therapy Clinical Trial, including laboratories and Third Parties used
to maintain the safety database from the Combined Therapy Clinical Trial, but,
for clarity, excluding clinical trial sites and any Third Parties who are
individuals.

 

“Cure Period” shall have the meaning set forth in Section 12.2(a).

 

[***]

 

[***]

 

“Date of First Receipt” means, with respect to a Party, the date on which any
employee of such Party, its Affiliates or its Third Party subcontractors first
becomes aware of safety-related information.

 

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“Designated Clinical Contact” shall have the meaning set forth in Section 2.3.

 

“Designated Supply Contact” shall have the meaning set forth in Section 4.7.

 

“Dispute” shall have the meaning set forth in Section 13.3(b).

 

“Effective Date” shall have the meaning set forth in the preamble to this
Agreement.

 

“Executive Officers” means the Chief Executive Officer of the Recipient and the
Head of Oncology Development of BMS (or their respective designees).

 

“FDA” means the United States Food and Drug Administration, or any successor
agency having the same or similar authority.

 

“Filing Party” shall have the meaning set forth in Section 6.1(c).

 

“Global Safety Database” means the database containing Adverse Events, Serious
Adverse Events, Serious Adverse Drug Reactions and pregnancy reports for the
Combined Therapy, and shall be the authoritative data source for regulatory
reporting and responding to regulatory queries with respect to the Combined
Therapy Clinical Trial.

 

“Good Clinical Practices” or “GCP” means, as to the United States and the
European Union, applicable good clinical practices as in effect in the United
States and the European Union, respectively, during the Term and, with respect
to any other jurisdiction, clinical practices equivalent to good clinical
practices as then in effect in the United States or the European Union.

 

“Good Laboratory Practices” or “GLP” means, as to the United States and the
European Union, applicable good laboratory practices as in effect in the United
States and the European Union, respectively, during the Term and, with respect
to any other jurisdiction, laboratory practices equivalent to good laboratory
practices as then in effect in the United States or the European Union.

 

“Good Manufacturing Practices” or “GMP” means, as to the United States and the
European Union, applicable good manufacturing practices as in effect in the
United States and the European Union, respectively, during the Term and, with
respect to any other jurisdiction, manufacturing practices equivalent to good
manufacturing practices as then in effect in the United States or the European
Union.

 

“ICF” shall have the meaning set forth in Section 5.1(f).

 

“IND” means (a) an Investigational New Drug Application as defined in the United
States Food, Drug and Cosmetic Act, as amended, and regulations promulgated
thereunder, or any successor application or procedure required to initiate
clinical testing of a drug in humans in the United States, (b) a counterpart of
such an Investigational New Drug Application that is required in any other
country before beginning clinical testing of a drug in humans in such country,
including, for clarity, a “Clinical Trial Application” in the European Union,
and (c) all supplements and amendments to any of the foregoing.

 

“Indemnify” shall have the meaning set forth in Section 11.1.

 

“Infringe” and “Infringement” means any alleged or threatened (in writing)
infringement, or misappropriation by a Third Party, of any Patent Rights.

 

“Invention” means any invention or Technology, whether or not patentable, that
is made, conceived, or first actually reduced to practice after the Effective
Date by, for or on behalf of a Party, or by, for or on behalf of the Parties
together (including by a Third Party in the performance of the Combined Therapy
Clinical Trial), (a) in relation to the Combined Therapy Clinical Trial to be
conducted under this Agreement or (b) by or resulting from the use of Study
Data, but excluding in each case any Study Data itself.

 

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“IRB” means an Investigational Review Board or Ethics Committee (or similar body
in a given country).

 

“Licensee” shall have the meaning set forth in Section 13.10(b).
“Losses” shall have the meaning set forth in Section 11.1.

 

“Manufacture” or “Manufacturing” means manufacturing, processing, formulating,
packaging, labeling, holding (including storage), and quality control testing of
a Single Agent Compound or the Combined Therapy, in each case so as to be
suitable for use in the Combined Therapy Clinical Trial under Applicable Law.

 

“Material Safety Issue” means a Party’s good faith belief that there is an
unacceptable risk for harm in humans based upon: (a) pre-clinical safety data,
including data from animal toxicology studies, or (b) the observation of Serious
Adverse Events in humans after the Recipient Study Drug or the BMS Study Drug,
either as a Single Agent Compound or in combination with another pharmaceutical
agent (including as the Combined Therapy), has been administered to or taken by
humans, such as during the Combined Therapy Clinical Trial.

 

“NDA” means (a) any new drug application or biologics license application filed
with the FDA, or any successor application or procedure required to introduce a
drug or biologic into commerce in the United States, (b) a counterpart of such a
new drug application or biologics license application that is required in any
other country before beginning the commercialization of a drug or a biologic in
humans in such country, and (c) all supplements and amendments to any of the
foregoing.

 

“Non-Breaching Party” shall have the meaning set forth in Section 12.2(a).

 

“Officials” shall have the meaning set forth in Section 10.9.

 

“Ono” means Ono Pharmaceutical Co., Ltd.

 

“Ono-BMS Agreements” means those certain Collaboration Agreements between BMS
and Ono dated as of September 20, 2011 and as of July 23, 2014, as amended from
time to time, and agreements between Ono and BMS and their Affiliates relating
thereto that may be in effect from time to time.

 

“Ono Territory” means Japan, South Korea and Taiwan.

 

“Operational Matters” shall have the meaning set forth in Section 5.1.

 

“Party” or “Parties” shall have the meaning set forth in the preamble to this
Agreement.

 

“Patent Rights” means any (a) United States or foreign patents, (b) United
States or foreign patent applications, including all provisional applications,
substitutions, continuations, continuations-in-part, divisions, renewals, and
all patents granted thereon, (c) United States or foreign patents-of-addition,
reissues, reexaminations (including ex parte reexaminations, inter partes
reviews, inter partes reexaminations, post grant reviews and supplemental
examinations) and extensions or restorations by existing or future extension or
restoration mechanisms, including supplementary protection certificates, patent
term extensions, or the equivalents thereof, and (d) any other form of
government-issued right substantially similar to any of the foregoing.

 

“Payment” shall have the meaning set forth in Section 10.9.

 

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

 

“Personal Data” means any information relating to an identified or identifiable
natural person.

 

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“POTV” shall have the meaning set forth in Section 9.6(a).

 

“Protocol” shall have the meaning set forth in the definition of Combined
Therapy Clinical Trial.

 

“Publication Dispute” shall have the meaning set forth in Section 9.5(b).

 

“Quarter” means a calendar quarter.

 

“Recipient Class Drug” means the Recipient Study Drug and any oncolytic virus
derived from a potent herpes simplex virus strain expressing gibbon ape leukemia
virus glycoprotein and eliciting anti-tumor activity.

 

“Recipient Indemnitees” shall have the meaning set forth in Section 11.1.

 

“Recipient Independent Patent Rights” means any Patent Rights Controlled by the
Recipient or a Recipient Affiliate (a) as of the Effective Date or (b) during
the Term the subject matter of which was conceived or first reduced to practice
through activities other than those performed pursuant to this Agreement, in
each case (a) and (b) that Cover the use (either alone or in combination with
other agents), manufacture, formulation or composition of matter of the
Recipient Study Drug.

 

“Recipient Regulatory Documentation” means any Regulatory Documentation
pertaining to the Recipient Study Drug that exists as of the Effective Date or
that is created during the Term through efforts outside this Agreement.

 

“Recipient Study Data” shall have the meaning set forth in Section 8.2.

 

“Recipient Study Drug” means the Recipient’s proprietary oncolytic virus known
as RP-2.

 

“Recipient Study Invention” means any Invention that pertains to (a) the
composition of matter of any Recipient Class Drug (and not any BMS Class Drug),
(b) method of manufacture or formulation of any Recipient Class Drug (and not
any BMS Class Drug) as a Single Agent Compound, or (c) a method of use of the
Recipient Class Drug (and not any BMS Class Drug) as a monotherapy or as used in
combination with other agents, antibodies or compounds (other than Invention
pertaining, whether generically or specifically, to the composition of matter,
method of manufacture, formulation or a method of use of both a BMS Class Drug
and a Recipient Class Drug.

 

“Recipient Study Patent Rights” means any Patent Rights that Cover any Recipient
Study Invention (and not a BMS Study Invention or a Combined Therapy Invention),
excluding Recipient Independent Patent Rights and Recipient Technology. For
avoidance of doubt, any Patent Rights that cover both (a) a Recipient Study
Invention and (b) any other type of Invention is included within the Combined
Therapy Patent Rights.

 

“Recipient Technology” means all Technology Controlled by the Recipient or a
Recipient Affiliate as of the Effective Date or during the Term which is created
through efforts outside of this Agreement related to the Recipient Study Drug or
the Combined Therapy and necessary for the conduct of the Combined Therapy
Clinical Trial. For clarity, Recipient Technology does not include
(a) Inventions, (b) Study Data, or (c) Combined Therapy Clinical Trial
Regulatory Documentation.

 

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

 

“Regulatory Documentation” means, with respect to a Party’s Single Agent
Compound, all submissions to Regulatory Authorities in connection with the
development of such Single Agent Compound, as applicable, 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).

 

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“Results” shall have the meaning set forth in Section 9.5(b).

 

“Right of Cross-Reference” means, 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 Single Agent Compound
(and, in the case of BMS, the Right to Cross-Reference the Combined Therapy
IND), only to the extent necessary for the conduct of the Combined Therapy
Clinical Trial in such country or as otherwise expressly permitted or required
under this Agreement to enable a Party to exercise its rights or perform its
obligations hereunder, and, except as to information contained in the Combined
Therapy IND pertaining to the Combined Therapy, without the disclosure of such
information to such Party.

 

“RP-1 Agreement” shall have the meaning set forth in the Preliminary Statements.

 

“Safety Issue” means any information suggesting an emerging safety concern or
possible change in the risk-benefit balance for a drug, including information on
a possible causal relationship between an Adverse Event and a drug, the
relationship being unknown or incompletely documented previously.

 

“Safety Signal” means information arising from one or multiple sources,
including observations and experiments, which suggests a new potentially causal
association, or a new aspect of a known association between an intervention and
an event or set of related events, either adverse or beneficial, that is judged
to be of sufficient likelihood to justify verificatory action.

 

“Samples” means biological specimens collected from Combined Therapy Clinical
Trial study subjects (including fresh and/or archived tumor samples, serum,
peripheral blood mononuclear cells, plasma, and whole blood for RNA and DNA
sample isolation).

 

“Shortage” shall have meaning set forth in Section 4.5.

 

“Single Agent Compound” or “Compound” means, with respect to (a) the Recipient,
the Recipient Study Drug, as monotherapy, and (b) BMS, the BMS Study Drug, as
monotherapy.

 

“Sponsor” means an applicant or holder of clinical studies
applications/notifications.

 

“Study Data” shall have the meaning set forth in Section 8.1.

 

“Sunshine Laws” shall have the meaning set forth in Section 9.6(c).

 

“Supply and Quality Documentation” shall have the meaning set forth in
Section 4.3.

 

“Technology” means information, inventions, discoveries, trade secrets,
knowledge, technology, methods, processes, practices, formulae, instructions,
skills, techniques, procedures, experiences, ideas, technical assistance,
designs, drawings, assembly procedures, computer programs, specifications, data
and results not generally known to the public (including biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and analytical,
pre-clinical, clinical, safety, manufacturing and quality control data and
know-how, including study designs and protocols), in all cases, whether or not
patentable, in written, electronic or any other form now known or hereafter
developed and materials, including Regulatory Documentation.

 

“Term” shall have the meaning set forth in Section 12.1.

 

“Territory” means the United States, including Puerto Rico, and the European
Union (including the United Kingdom, whether or not an EU member state). For
clarity, the Territory excludes the Ono Territory.

 

“Third Party” means any Person or entity other than the Recipient and BMS and
their respective Affiliates.

 

“Third Party Claim” shall have the meaning set forth in Section 11.1.

 

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“Third Party License Payments” means any payments (e.g., upfront payments,
milestones, royalties) due to any Third Party under license agreements or other
written agreements granting rights to intellectual property owned or controlled
by such Third Party to the extent that such rights are necessary for (a) the
making, using or importing of a Party’s Single Agent Compound for the conduct of
the Combined Therapy Clinical Trial, or (b) the conduct of the Combined Therapy
Clinical Trial.

 

“TP Study Costs” shall have the meaning set forth in Section 7.2.

 

ARTICLE 2
SCOPE

 

2.1                               Scope.

 

(a)                                 The Recipient will conduct the Combined
Therapy Clinical Trial in accordance with the Protocol and the terms of this
Agreement. The Parties will use good faith efforts to jointly agree on a draft
Protocol within [***] following the Effective Date, which shall be based on the
draft Protocol summary attached as Appendix A hereto. The Recipient shall be
solely responsible for the content of the Protocol following agreement by the
Parties on the draft Protocol; provided that: (i) the Recipient will notify BMS
of any proposed amendments to the draft Protocol agreed by the Parties (or to
the final Protocol initially approved by an IRB) and the Recipient will consider
any comments provided by BMS regarding the proposed amendments (it being
understood that the Parties will endeavor to set forth in writing the
circumstances (e.g., administrative matters) where it may be feasible for the
Recipient to make specific Protocol amendments without the need for BMS to
comment), and (ii) any changes to the draft Protocol agreed by the Parties (or
to the final Protocol initially approved by an IRB) that pertain to the
administration of the BMS Study Drug must be reviewed and expressly approved by
BMS in writing or the change may not be implemented. BMS shall have [***] from
the date on which the Recipient provides the applicable Protocol amendment to
BMS to approve or provide any comments to the Recipient concerning the proposed
amendment. For clarity, Recipient shall not conduct any patient recruitment
activities for, or otherwise initiate, the Combined Therapy Clinical Trial until
the draft Protocol is jointly agreed by the Parties.

 

(b)                                 The Combined Therapy Clinical Trial shall be
conducted under a combination IND, for which the Recipient will be the sponsor
of record (the “Combined Therapy IND”) and shall be conducted only in the
Territory. The Recipient shall be the sole holder of all legal interests in the
Combined Therapy IND; provided, however, that the Recipient may not grant any
Third Party any Right of Cross-Reference with respect to any portion of the
Combined Therapy IND pertaining to BMS’s Single Agent Compound for use as
monotherapy or for use in combination with any molecules, agents, antibodies or
compounds other than the Recipient Study Drug.

 

(c)                                  BMS will make available its current package
insert for the BMS Study Drug in the Territory available to the Recipient and
will provide any updates thereto at the same time as the same are made publicly
available.

 

(d)                                 If the Recipient and BMS agree that the
Recipient will require access to the investigator’s brochure for the BMS Study
Drug in order for the site to conduct the Combined Therapy Clinical Trial, then
(i) BMS will provide the current version of its investigator brochure to the
Recipient promptly and (ii) will thereafter, until the conclusion of the
Combined Therapy Clinical Trial, provide to the Recipient, upon reasonable
request, the latest investigator’s brochure for the BMS Study Drug or any
amendments thereto in accordance with BMS’s customary practices for same. The
Recipient shall, and shall require that any clinical trial sites for the
Combined Therapy Clinical Trial shall, use any such data provided pursuant to
this Section 2.1(d) solely (A) to evaluate the safety and efficacy of the BMS
Study Drug and the Combined Therapy for use in Combined Therapy Clinical Trial,
(B) to meet any regulatory requirements pertaining to the conduct of the
Combined Therapy Clinical Trial and (C) to enable the Recipient to draft and
update as necessary the investigator’s brochure for the Combined Therapy
Clinical Trial. The Recipient will ensure that clinical trial sites for the
Combined Therapy Clinical Trial are obligated to protect such

 

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information and disclosures as set forth in Article 9. The Recipient’s right to
use the investigator’s brochure provided by BMS shall terminate upon the
completion or termination of the Combined Therapy Clinical Trial and shall not
be used for purposes of conducting any other clinical studies.

 

(e)                                  If requested in writing by the Recipient
and agreed to by BMS (such consent not to be unreasonably withheld), BMS shall
provide a Right of Cross-Reference as needed to its existing Regulatory
Documentation for BMS’s Single Agent Compound for those countries in the
Territory where the Combined Therapy Clinical Trial will be conducted solely as
necessary to allow the Combined Therapy Clinical Trial to be conducted under the
Combined Therapy IND in an applicable country; provided that such Right of
Cross-Reference shall terminate upon the expiration or termination of this
Agreement and shall not be used for purposes of conducting any other clinical
studies, except that, in the case of termination for a Material Safety Issue
pursuant to Section 12.4, such Right of Cross-Reference shall remain in effect
solely (i) to the extent necessary to permit the Recipient to comply with any
outstanding obligations required by a Regulatory Authority and/or Applicable Law
or (ii) as necessary to permit the Recipient to continue to dose subjects
enrolled in the Combined Therapy Clinical Trial through completion of the
Protocol if required by the applicable Regulatory Authority(ies) and/or
Applicable Laws.

 

(f)                                   If PDL-1 biomarker testing is incorporated
into the Protocol, the Recipient agrees to use the commercially available [***]
to perform such testing.

 

(g)                                 The Recipient shall refer to the applicable
BMS Study identification number in all Combined Therapy Clinical Trial reports,
reports of Serious Adverse Events, BMS Study Drug requests, and all other
material submissions or communications to BMS relating to the Protocol.

 

2.2                               Adverse Event Reporting.

 

(a)                                 This Section 2.2 shall govern safety
reporting arising from the Combined Therapy Clinical Trial. The Recipient will
manage all drug safety reporting activities for the Combined Therapy Clinical
Trial.

 

(b)                                 The Recipient will forward to BMS at the
contact information below via fax or secure e-mail in a format to be agreed to
by the Parties all fatal or life threatening SAE reports within four
(4) calendar days of Date of First Receipt, all other SAE reports, reports of
exposure during pregnancy (maternal and paternal) and reports of suspected
transmission of an infectious agent via the BMS Study Drug or Combined Therapy
within nine (9) calendars days of Date of First Receipt, in each case for the
BMS Study Drug and the Combined Therapy administered in the Combined Therapy
Clinical Trial.

 

BMS — Adverse Event Reporting Contact

E-mail

 

[***]

Fax

 

[***]

Acknowledgment of ICSR receipt:

 

[***]

 

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(c)                                  Each Party shall collect, use and disclose
Personal Data obtained in the course of performing the pharmacovigilance
activities under this Section 2.2 solely for the purposes of complying with the
regulatory obligations as described in this Agreement, or as otherwise required
by Applicable Law or by a court order. Both Parties will use electronic,
physical, and other safeguards appropriate to the nature of the information to
prevent any use or disclosure of Personal Data other than as provided for by
this Agreement and permitted under the ICF. Both Parties will also take
reasonable precautions to protect such Personal Data from accidental,
unauthorized, or unlawful alteration or destruction. Each Party will notify the
other Party promptly of any accidental, unauthorized, or unlawful destruction,
loss, alteration, or disclosure of, or access of such Personal Data.

 

(d)                                 The Recipient will promptly make available
to BMS upon request such records that the Recipient Controls as is necessary or
useful to perform medical assessment of any Adverse Event associated with the
use of the BMS Study Drug or Combined Therapy reported during the Combined
Therapy Clinical Trial that is forwarded to BMS under this Agreement. The
Recipient will designate a single point of contact within its organization (and
will provide to BMS the email address of such point of contact prior to the
start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related
follow-up questions that BMS would have.

 

(e)                                  The Recipient shall perform case level
reconciliation to confirm that BMS has received all reports required under this
Agreement. The Recipient shall e-mail [***] to request a reconciliation report
for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases
identified as being transmitted to BMS on BMS’s reconciliation report and those
contained in the Combined Therapy Clinical Trial database. The Recipient shall
send missing case-level events to BMS Global Pharmacovigilance at [***] or by
fax at [***]. The Recipient shall perform such reconciliation every [***],
unless otherwise agreed by BMS in writing.

 

(f)                                   As Sponsor, the Recipient will be
responsible for submitting all applicable Individual Case Safety Report (ICSRs)
and aggregate report submissions to Regulatory Authorities for the Combined
Therapy Clinical Trial. The Recipient will provide BMS with the final version of
any aggregate report at the time of submission. The Recipient will also submit
appropriate safety letters or safety reports to study investigators, the
reviewing IRB and authorized Regulatory Authorities in accordance with
Applicable Law.

 

(g)                                 In the event that BMS produces any
Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS
will provide to the Recipient upon request, and for the duration of the Combined
Therapy Clinical Trial, copies of the executive summary and any line listings of
Serious Adverse Drug Reactions extracted from the final DSUR for information
purposes only and to assist the Recipient in generation of their own clinical
trial aggregate report, where applicable. The Recipient agrees not to forward
such BMS DSUR sections to any Third Party, except to its Affiliates,
consultants, advisors and contractors under obligations of confidentiality for
generation of such a clinical trial aggregate report or as otherwise permitted
with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and
(f).

 

(h)                                 If the Recipient determines there is a
significant Safety Issue or significant Safety Signals arising in a clinical
trial that may be associated with the BMS Study Drug or Combined Therapy, the
Recipient will disclose such information to BMS promptly after such
determination.

 

(i)                                    BMS will ensure that any urgent Safety
Issues or Safety Signals relating to the BMS Study Drug will be communicated to
the Recipient promptly after such determination.

 

2.3                               Clinical Study Designated Contact. Each Party
will designate an employee within its organization (the “Designated Clinical
Contact”) who will coordinate and/or facilitate:

 

(a)                                 the review of Protocol amendments submitted
by the Recipient for BMS approval and with whom comments thereon may be
discussed;

 

(b)                                 any BMS clinical and regulatory
responsibilities and communications regarding the Combined Therapy Clinical
Trial;

 

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(c)                                  internal BMS review of any document or
regulatory communication and the provision of any BMS comments; and

 

(d)                                 discussion of any other topics or issues
relating to the Combined Therapy Clinical Trial requested by the Recipient or
BMS.

 

2.4                             Conduct. Each Party shall use Commercially
Reasonable Efforts to (a) perform and fulfill its respective activities under
the Combined Therapy Clinical Trial and this Agreement on a timely basis and in
an effective manner consistent with prevailing standards, (b) supply the
quantities of its Compound in accordance with Article 4 as needed to conduct the
Combined Therapy Clinical Trial on a timely basis, and, in the case of the
Recipient, package and deliver same to study sites on a timely basis, and (c) in
the case of the Recipient, conduct and complete the Combined Therapy Clinical
Trial on a timely basis in accordance with the Protocol and Third Party
agreements relating thereto, and provide sufficient resources, funding and
personnel to conduct and perform the Combined Therapy Clinical Trial on a timely
basis in accordance with the Protocol for same and the terms of this Agreement.
Each Party shall perform its duties for the Combined Therapy Clinical Trial in
accordance with Applicable Law, including GCP, GLP and GMP as applicable.

 

ARTICLE 3

 

LICENSE GRANTS

 

3.1                             Grant by BMS. Subject to the terms of this
Agreement, BMS hereby grants, and shall cause its Affiliates to grant, to the
Recipient a non-exclusive, non-transferable, royalty-free license (with the
right to sublicense solely pursuant to the terms of and subject to the
limitations of Section 3.2) under the BMS Independent Patent Rights and BMS
Technology to use the BMS Study Drug solely within the Territory and solely to
the extent necessary to discharge the Recipient’s obligations under this
Agreement with respect to the conduct of the Combined Therapy Clinical Trial in
the Territory.

 

3.2                             Sublicensing.

 

(a)                                 The Recipient shall have the right to grant
sublicenses under the licenses granted to it under Section 3.1, to Affiliates
and to Third Parties, if required for an Affiliate or a Third Party to perform
its duties with respect to the conduct of the Combined Therapy Clinical Trial,
solely as necessary to assist the Recipient in carrying out its responsibilities
with respect to the Combined Therapy Clinical Trial.

 

(b)                                 With regard to any such sublicenses
permitted and made under this Agreement, (i) the sublicensees, except Affiliates
(so long as they remain Affiliates of a Party), shall be subject to written
agreements that bind such sublicensees to obligations that are consistent with a
Party’s obligations under this Agreement including confidentiality and non-use
provisions no less restrictive than those set forth in herein, and provisions
regarding intellectual property that ensure that the Parties will have the
rights provided under this Agreement to any intellectual property relating to
their Single Agent Compound and/or the Combined Therapy created by such
sublicensee, (ii) each Party shall provide written notice to the other Party of
any such sublicense (and obtain approval for sublicenses to Third Parties other
than clinical trial sites); and (c) the licensing Party shall remain liable to
the other Party for all actions of the sublicensing Party’s sublicensees.

 

3.3                             No Implied Licenses. Unless and except as
specifically set forth in this Agreement, neither Party shall acquire any
license or other intellectual property interest, by implication or otherwise, in
any intellectual property of the other Party, including Confidential Information
disclosed to it under this Agreement or under any Patent Rights Controlled by
the other Party or its Affiliates.

 

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ARTICLE 4

 

MANUFACTURE AND SUPPLY

 

4.1                             Recipient Study Drug Manufacture and Supply.

 

(a)                                 The Recipient shall be responsible, at its
sole costs and expense, for manufacturing, packaging and labeling (or having
manufactured, packaged or labeled) GMP-grade quantities of the Recipient Study
Drug, as well as obtaining any other drug (other than the BMS Study Drug
provided by BMS pursuant to Section 4.2) required for the conduct of the
Combined Therapy Clinical Trial, and shall package and label if and as required
by the Protocol and/or applicable Regulatory Authorities all drugs (including
the BMS Study Drug) used in the Combined Therapy Clinical Trial, on a timely
basis and in accordance with applicable specifications as required for the
conduct of the Combined Therapy Clinical Trial. The Recipient Study Drug shall
be manufactured in accordance with Applicable Law (including GMP) and shall be
of similar quality to the Recipient Study Drug used by the Recipient for its
other clinical trials of the Recipient Study Drug.

 

(b)                                 The Recipient shall provide BMS with prompt
notice of any Manufacturing and supply issues with respect to the Recipient
Study Drug, or any defects or manufacturing problems identified with respect to
the BMS Study Drug supplied to Recipient, that may adversely impact the conduct
or timelines of the Combined Therapy Clinical Trial.

 

4.2                             BMS Study Drug.

 

(a)                                 Manufacture and Supply. BMS shall
Manufacture or have Manufactured the BMS Study Drug in reasonable quantities
needed, and at the points in time as agreed to by the Parties, for the Combined
Therapy Clinical Trial, and shall supply such BMS Study Drug as either
commercially labeled or unlabeled vials to the Recipient or its designee for use
solely in the Combined Therapy Clinical Trial. The Recipient will at its sole
expense, package and label the BMS Study Drug for use in the Combined Therapy
Clinical Trial to the extent necessary. The cost of Manufacture and supply
(including shipping, taxes and duty, if applicable) of the BMS Study Drug for
the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall
bear the risk of loss for such quantities of BMS Study Drug until delivery of
such quantities of BMS Study Drug to the Recipient or its designee. BMS shall
also be responsible for the payment of any Third Party License Payments that may
be due based on the manufacture, supply and use of the BMS Study Drug used in
the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in
accordance with Applicable Law (including GMP) and shall be of similar quality
to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study
Drug. BMS shall deliver certificates of analysis, and any other documents
specified in the Supply and Quality Documentation, including such documentation
as is necessary to allow the Recipient to compare the BMS Study Drug certificate
of analysis to the BMS Study Drug specifications. Pursuant to the Supply and
Quality Documentation, BMS shall be responsible for the regulatory compliance of
the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to
the Recipient with the regulatory filings in the countries in the Territory
where the Combined Therapy Clinical Trial will be performed. Subject to
Section 4.4, the Parties shall cooperate in accordance with Applicable Law to
minimize indirect taxes (such as value added tax, sales tax, consumption tax and
other similar taxes) relating to the BMS Study Drug in connection with this
Agreement.

 

(b)                                 Use of BMS Study Drug Supplied by BMS to the
Recipient. The Recipient shall use the quantities of BMS Study Drug supplied to
it under this Agreement solely as necessary for, and in accordance with, this
Agreement and the Protocol, and for no other purpose, including as a reagent or
tool to facilitate its internal research efforts, for any commercial purpose, or
for other clinical or non-clinical research unrelated to the Combined Therapy
Clinical Trial. Except as may be required or expressly permitted by the Protocol
or the Supply and Quality Documentation, the Recipient shall not perform, and
shall not allow any Third Party to perform, any analytical testing of the
quantities of BMS Study Drug supplied to it under this Agreement. If Study Drug
supplied by BMS is lost, damaged, destroyed or becomes unable to comply with
applicable specifications while under the control of the Recipient or any of its
(sub)contractors, including common carriers and clinical study sites contracted
by the Recipient, BMS shall not be obligated to replace same, and if BMS does
elect to do so, BMS may elect to charge the Recipient a reasonable replacement
cost to replace same. Notwithstanding Section 4.2(b) of the RP-1 Agreement, the
Recipient may use BMS Study Drug supplied to it under the RP-1 Agreement (to the

 

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extent such BMS Study Drug is not necessary for the purposes of the RP-1
Agreement) pursuant to this Section 4.2(b) as though it was supplied under this
Agreement.

 

4.3                        Supply and Quality Documentation. BMS shall supply
the BMS Study Drug to the Recipient in accordance with such supply and quality
addenda or agreement(s) as the Parties may agree (the “Supply and Quality
Documentation”). The Parties shall finalize and execute the Supply and Quality
Documentation within [***] of the Effective Date, but in no event later than the
date on which the first shipment of the BMS Study Drug is supplied for use in
the Combined Therapy Clinical Trial. The Supply and Quality Documentation shall
outline the additional roles and responsibilities relative to the quality of BMS
Study Drug in support of the Combined Therapy Clinical Trial. It shall include
the responsibility for quality elements as well as exchanged GMP documents and
certifications required to release the BMS Study Drug for the Combined Therapy
Clinical Trial. In addition, the Supply and Quality Documentation shall detail
the documentation required for each shipment of BMS Study Drug supplied to the
Recipient or its designee for use in the Combined Therapy Clinical Trial.

 

4.4                        Supply Forecast. Estimated supply and delivery
details will be outlined in the Supply and Quality Documentation and will be
updated by the Parties by mutual agreement (which agreement can be effected by
the Parties’ Designated Supply contacts and without need for an amendment to
this Agreement) based on the actual enrollment. The Recipient will promptly
inform BMS of any change in its requirements, and BMS will endeavor to
accommodate any change in the supply quantities requested by the Recipient so
long as it does not unduly disrupt BMS’s ongoing business activities.

 

4.5                        Shortages. BMS shall provide the Recipient with
prompt notice of any Manufacturing and supply issues with respect to the BMS
Study Drug that may adversely impact the conduct or timelines of the Combined
Therapy Clinical Trial. In the event of a supply interruption or shortage of BMS
Study Drug as determined by BMS pursuant to its internal processes and policies
(a “Shortage”), such that BMS reasonably believes that it will not be able to
fulfill its supply obligations under this Agreement, BMS will provide prompt
written notice thereof to the Recipient (including the quantity of BMS Study
Drug that BMS reasonably estimates it will be able to supply) and, upon request,
the Parties will promptly discuss such situation (including how the quantities
of BMS Study Drug that BMS is able to supply under this Agreement will be
allocated within the Combined Therapy Clinical Trial). Notwithstanding anything
to the contrary contained herein, in the event of a Shortage of the BMS Study
Drug, BMS will have sole discretion, subject to Applicable Law, to determine the
quantity of BMS Study Drug it will be able to supply as a result of such
Shortage; provided, however, that BMS shall consider in good faith the needs of
patients who are actively being treated with BMS Study Drug, including Combined
Therapy Clinical Trial patients, in making such determination. BMS will not be
deemed to be in breach of this Agreement for failure to supply any other
quantities of BMS Study Drug hereunder as a result of a Shortage. Any such
allocation of the BMS Study Drug in accordance with this Section 4.5 will be the
Recipient’s exclusive remedy with respect to a Shortage.

 

4.6                        Customs Valuation. The Recipient will provide BMS in
writing with a list of each country in which it proposes to conduct the Combined
Therapy Clinical Trial prior to execution of any site agreement or CRO agreement
for that country. During the conduct of the Combined Therapy Clinical Trial, the
Recipient will send in writing any changes to the list of participating
countries to BMS one month prior to the end of each Quarter. If no changes are
sent to BMS by the Recipient for a particular Quarter, the prior Quarter’s
participating country list will be used as the basis for customs valuation for
that Quarter. BMS will provide the Recipient with country-specific customs
valuations initially for the BMS Study Drug prior to initiation of the Combined
Therapy Clinical Trial and at the end of each Quarter during the conduct of the
Combined Therapy Clinical Trial. The Recipient will use the BMS provided values
for the import/export process to the listed participating countries and not make
any change to such valuations without BMS’s prior written consent.

 

4.7                               Designated Supply Contact. Each Party will
designate an individual (the “Designated Supply Contact”) that a Party may
contact to assist with coordinating supplies and facilitating the resolution of
any issues or concerns arising in connection with the supply of the BMS Study
Drug for use in the Combined Therapy Clinical Trial.

 

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ARTICLE 5

 

RESPONSIBILITIES

 

5.1                                    Specific Responsibilities of the
Recipient. The Recipient shall, subject to the terms of the Protocol, applicable
terms and conditions of this Agreement, and any other agreement between the
Parties relating to the Combined Therapy Clinical Trial, manage and be
responsible for the conduct of the Combined Therapy Clinical Trial, including
timelines and contingency planning. In particular, and not in limitation of the
foregoing, the Recipient shall perform (itself and/or through Third Parties,
including clinical trial sites, CROs and investigators) and/or be responsible
for the following (items (a) to (p) below, collectively the “Operational
Matters”) with respect to the Combined Therapy Clinical Trial:

 

(a)                                 compiling, amending and filing all necessary
Combined Therapy Clinical Trial Regulatory Documentation with Regulatory
Authority(ies), maintaining and acting as the sponsor of record as provided in
21 CFR 312.50 (and applicable comparable ex-US laws) with responsibility, unless
otherwise delegated in accordance with 21 CFR 312.52 (and applicable comparable
ex-US laws), for the Combined Therapy Clinical Trial and making all required
submissions to Regulatory Authorities related thereto on a timely basis;

 

(b)                                 conducting clinical study start-up
activities, communicating with and obtaining approval from IRBs for the Protocol
and other relevant documents for the Combined Therapy Clinical Trial as
applicable, as well as patient recruitment and retention activities;

 

(c)                                  listing of the Combined Therapy Clinical
Trial, if it is required to be listed on a public database on
www.clinicaltrials.gov or other public registry in any country in which such
Combined Therapy Clinical Trial is being conducted, all in accordance with
Applicable Law and in accordance with its internal policies relating to clinical
trial registration;

 

(d)                                 providing BMS with reasonable advance notice
of scheduled meetings or other pre-planned non-written communications with a
Regulatory Authority and the opportunity to participate in each such meeting or
other non-written communication, to the extent involving a safety, efficacy or
toxicology issue relating to the Combined Therapy or the BMS Study Drug or any
other matter related to the Combined Therapy or Combined Therapy Clinical Trial
that it determines in its reasonable judgement could potentially have an adverse
effect on the BMS Study Drug. In such case, the Recipient will provide BMS with
the opportunity to review, provide comments to the Recipient within [***] on,
and, if inconsistent with the Protocol, approve all submissions and written
correspondence with a Regulatory Authority that relates to the BMS Study Drug;

 

(e)                                  provide BMS (i) a written notice to the BMS
Designated Clinical Contact (via email to the email address designated by BMS)
of meetings or other substantive non-written communications with a Regulatory
Authority within [***] of such meeting or communication, and if requested by BMS
following such notice, a written summary of such meeting or communication within
ten (10) days of such request, and (ii) copies of any official correspondence to
or from a Regulatory Authority within [***] of receipt or provision, in each
case of (i) or (ii) to the extent involving a safety, efficacy or toxicology
issue relating to the Combined Therapy or the BMS Study Drug or any other matter
related to the Combined Therapy or Combined Therapy Clinical Trial that it
determines in its reasonable judgement could potentially have an adverse effect
on the BMS Study Drug, and copies of all material Combined Therapy Clinical
Trial Regulatory Documentation and correspondence that relates to same within
[***] of submission to Regulatory Authorities;

 

(f)                                   subject to the terms of this Agreement,
the selection and payment of, negotiation of the terms of, contracting with,
managing and overseeing compliance of its agreement by and the receipt of
contract deliverables from, any CRO or vendor selected by the Recipient to
assist in the performance of the Combined Therapy Clinical Trial. The Recipient
shall determine and approve contract deliverables and manage contract
performance, including executing site contracts, drafting and obtaining IRB
approval for site informed consent forms (each an “ICF”), obtaining signed ICFs,
monitoring plans, etc. The Recipient will be responsible for ensuring that all
such contracts and ICFs: (i) do not conflict with the terms of this Agreement,
(ii) allow the Recipient to provide BMS with access to and use of Study Data,
Samples, and

 

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other information and documents as required pursuant to this Agreement (and in
no event less than the same use rights granted to the Recipient), (iii) do not
impose a new obligation, whether direct, indirect, or contingent, upon BMS that
is not set forth in this Agreement, and (iv) retain each of the Parties’
respective intellectual property rights in and access to the BMS Technology, BMS
Independent Patent Rights, Study Data, Samples, Recipient Study Drug, BMS Study
Drug and Combined Therapy consistent with this Agreement, and (vi) comply with
Applicable Law;

 

(g)                                 providing BMS (if requested by BMS) with
copies of each final site template of the Combined Therapy Clinical Trial’s ICF.
The Recipient shall ensure that each ICF does not impose any financial
obligation, liability, damages or other cost upon BMS with respect to any injury
(including death) suffered by a Combined Therapy Clinical Trial subject whether
or not resulting from the administration of the BMS Study Drug or direct a study
subject to BMS to seek reimbursement for any costs or seek compensation for any
injury incurred in connection with the Combined Therapy Clinical Trial;

 

(h)                                 if requested by BMS, providing BMS within
[***] with minutes from any and all external drug safety monitoring boards for
the Combined Therapy Clinical Trial after receipt by the Recipient, to the
extent relating to the BMS Study Drug or the Combined Therapy;

 

(i)                                    informing and updating BMS on a [***]
basis (with significant issues to be communicated promptly after the Recipient
becomes aware of same) regarding all Operational Matters, so that if BMS has any
significant concerns or material disagreements regarding same, the matter can be
discussed with the Recipient. Without limiting the foregoing, the Recipient
shall inform BMS [***] as to the overall Combined Therapy Clinical Trial
progress, [***], and any other Combined Therapy Clinical Trial-related matters
requested by BMS to the extent involving a safety, efficacy or toxicology issue
relating to the Combined Therapy or the BMS Study Drug or any other matter that
could have an adverse effect on the BMS Study Drug;

 

(j)                                    owning and being responsible for (or
appointing a Third Party to be responsible for) the maintenance of the Global
Safety Database and being responsible for safety reporting, collecting,
evaluating and reporting Serious Adverse Events, other safety data and any
further pharmacovigilance information from the Combined Therapy Clinical Trial;

 

(k)                                 analyzing the Study Data in a timely fashion
and providing BMS with access to the Study Data as follows:

 

(i)                                    top line data and a copy of all Clinical
Study Reports (CSRs), in each case, as and when received by the Recipient’s
clinical management;

 

(ii)                                if requested by BMS, sharing with BMS for
review and comment drafts of interim and/or final clinical trial report (and/or
statistical analysis in accordance with the Protocol) from the Combined Therapy
Clinical Trial;

 

(iii)                            if requested by BMS, within [***] after
database lock, access to those safety databases that will be used for any
interim review by an external consultant (or drug safety monitoring board, if
required);

 

(iv)                             if requested by BMS, within [***] after
database lock, access to case report forms or patient profiles for all patients
in the Combined Therapy Clinical Trial;

 

(v)                                 if requested by BMS, within [***] of the
creation of an electronic clean database for the Combined Therapy Clinical
Trial, an electronic copy of the clean database (the form and format of the
clean database to be reasonably acceptable to both Parties);

 

(vi)                             if requested by BMS, subject to any third party
requirements, providing BMS with any programs or SAS codes to be used for any
statistical analysis plan for the Combined Therapy Clinical Trial; and

 

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(vii)                         (A) safety analyses, (B) new and/or changing
Safety Signals and Safety Issues, (C) new and/or changing toxicology and
efficacy signals, and (D) any statistical analysis, immunogenicity analysis, or
bioanalysis, in each case relating to the BMS Study Drug, the Recipient Study
Drug and/or the Combined Therapy, as and when the same are received by the
Recipient;

 

(l)                                    obtaining supplies of any co-medications,
to the extent any such co-medications are required for use in the Combined
Therapy Clinical Trial, and providing to BMS any information related to the
Combined Therapy Clinical Trial that is provided to the manufacturer of any
co-medication within [***] after the provision of the information to the
manufacturer;

 

(m)                             if requested by BMS, information that Recipient
has available to it as of such time (and with no duty to conduct any interim
analysis) regarding either (i) the pharmacokinetics and safety of the Recipient
Study Drug alone or (ii) the pharmacokinetics, efficacy and safety of the
Recipient Study Drug in combination with the BMS Study Drug;

 

(n)                                 performing either directly or through third
parties collection of Samples required by the Protocol;

 

(o)                                 handling and addressing inquiries from the
Combined Therapy Clinical Trial subjects and investigators; and

 

(p)                                 such other responsibilities as may be agreed
to by the Parties.

 

5.2                               BMS Operational Responsibilities. BMS shall be
responsible for the following activities:

 

(a)                                 Manufacturing and supplying GMP-grade
quantities of the BMS Study Drug, as further described in Article 4 above, and,
where and to the extent provided in the Supply and Quality Documentation,
providing necessary GMP information and documentation that enables the Recipient
Qualified Person (as such term will be defined in the Supply and Quality
Documentation) to release BMS Study Drug for the Combined Therapy Clinical
Trial;

 

(b)                                 where and to the extent provided in the
Supply and Quality Documentation, providing for the release by a Qualified
Person or providing the necessary documentation in support of such quality
release, of the BMS Study Drug if such release is required for the Combined
Therapy Clinical Trial;

 

(c)                                  to the extent necessary for the conduct of
the Combined Therapy Clinical Trial, providing a Right of Cross-Reference to the
relevant Regulatory Documentation for the BMS Study Drug as set forth in
Section 2.1(b) and/or (e), if applicable, to the BMS investigator’s brochure for
the BMS Study Drug (and updates thereto) as provided in Section 2.1(d); and

 

(d)                                 such other responsibilities as may be agreed
to by the Parties.

 

5.3                            Other Clinical Trials. Nothing in this Agreement
shall preclude either Party from conducting any other clinical trials as it may
determine in its discretion, so long as it does not use or rely on the
Confidential Information that is solely owned by the other Party in doing so.

 

5.4                            Potential Subsequent Studies. During the Term,
each of the Parties agrees to discuss in good faith, for a period of no longer
than [***], additional Combined Therapy Clinical Trials of the BMS Study Drug
with the Recipient Study Drug (and/or follow-on versions of the Recipient Study
Drug). If the Parties jointly agree to conduct any such further clinical trials
(each, a “Subsequent Study”), this Agreement and the Supply and Quality
Documentation shall be amended to provide for such Subsequent Study under the
terms thereof. The Parties agree to discuss whether it may be useful or
desirable to include Ono as part of a Subsequent Study. For clarity, no Party
shall be obligated to collaborate with the other Party or agree on terms with
the other Party with respect to any additional clinical trials (or other
collaboration opportunities) pursuant to this Section 5.4.

 

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ARTICLE 6

 

INTELLECTUAL PROPERTY

 

6.1                            Inventions and Related Patent Rights. All rights
to Inventions shall be allocated as follows:

 

(a)                                 Recipient Ownership. Subject to the terms of
this Agreement, all Recipient Study Inventions and Recipient Study Patent Rights
shall be owned solely by the Recipient, and the Recipient will have the full
right to exploit such Recipient Study Inventions and Recipient Study Patent
Rights without the consent of, or any obligation to account to, BMS. BMS shall
assign and hereby assigns (and shall cause its Affiliates and contractors to
assign) its right, title and interest in any Recipient Study Inventions and
Recipient Study Patent Rights to the Recipient. BMS shall execute such further
documents and provide other assistance as may be reasonably requested by the
Recipient to perfect the Recipient’s rights in such Recipient Study Inventions
and Recipient Study Patent Rights, all at the Recipient’s expense. The Recipient
shall have the sole right but not the obligation to prepare, file, prosecute
(including any proceedings relating to reissues, reexaminations, protests,
interferences, oppositions, post-grant reviews or similar proceedings and
requests for patent extensions) and maintain any Recipient Study Patent Rights
at its own expense.

 

(b)                                 BMS Ownership. Subject to the terms of this
Agreement, all BMS Study Inventions shall be owned solely by BMS, and BMS will
have the full right to exploit such BMS Study Inventions without the consent of,
or any obligation to account to, the Recipient. The Recipient shall assign and
hereby assigns (and shall cause its Affiliates and contractors to assign) all
its right, title and interest in any BMS Study Inventions and BMS Study Patent
Rights to BMS. The Recipient shall execute such further documents and provide
other assistance as may be reasonably requested by BMS to perfect BMS’s rights
in such BMS Study Inventions and BMS Study Patent Rights, all at BMS’s expense.
BMS shall have the sole right but not the obligation to prepare, file, prosecute
(including any proceedings relating to reissues, reexaminations, protests,
interferences, oppositions, post-grant reviews or similar proceedings and
requests for patent extensions) and maintain any BMS Study Patent Rights at its
own expense.

 

(c)                                  Combined Therapy Inventions.

 

(i)                                    All Combined Therapy Inventions and
Combined Therapy Patent Rights shall be jointly owned by the Parties, and either
Party shall have the right to freely exploit the Combined Therapy Inventions and
Combined Therapy Patent Rights, both within and outside the scope of this
Agreement, without accounting or any other obligation to the other Party (except
as expressly set forth in this Section 6.1(c) and Section 6.3(d) with regard to
the filing, prosecution, maintenance and enforcement of Combined Therapy Patent
Rights) and each Party may use, exploit and grant licenses (with right to
sublicense) to Third Parties under its interest in such Combined Therapy
Inventions and Combined Therapy Patent Rights. The Recipient, using outside
counsel acceptable to both Parties, shall be responsible, at its sole
discretion, for preparing and prosecuting Patent applications and maintaining
Patents within the Combined Therapy Patent Rights. The Recipient shall keep BMS
advised as to material developments and steps to be taken with respect to
prosecuting any such Patent Rights and shall furnish BMS with copies of
applications for such Patent Rights, amendments thereto and other related
correspondence to and from patent offices, and permit BMS a reasonable
opportunity to review and offer comments prior to submitting such applications
and correspondence to the applicable governmental authority (and will take BMS’s
comments into account in preparing same). BMS shall reasonably assist and
cooperate in obtaining, prosecuting and maintaining the Combined Therapy Patent
Rights.

 

(ii)                                Notwithstanding the foregoing clause (i),
the Recipient shall not take any position in a submission to a patent office
concerning a Combined Therapy Invention that interprets the scope of a Patent
Right of BMS without the prior written consent of BMS, provided that BMS has
notified the Recipient in writing of the existence and scope of such BMS Patent
Right. The Recipient shall be reimbursed for any costs and expenses incurred in
prosecuting Combined Therapy Patent Rights and the subsequent maintenance of
Combined Therapy Patent Rights by BMS such that BMS shall be responsible for
[***] of such costs. From time-to-time, the Recipient shall invoice BMS such
amounts and BMS shall pay the Recipient such invoiced amounts within thirty (30)
days after receipt of an invoice therefor.

 

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(iii)                            The Parties shall discuss in good faith the
countries in which the Combined Therapy Patent Rights will be filed. In case one
of the two Parties decides that Combined Therapy Patent Right should not be
filed or maintained in a given country (and also elects not to reimburse the
other Party for [***] of the costs of prosecution and maintenance of such
Combined Therapy Patent Right in such country), the other Party shall have the
right to file, prosecute and maintain such Combined Therapy Patent Right in such
country in its own name and at its own expense upon the prior consent of the
other Party, which shall not be unreasonably withheld, conditioned or delayed.
In this case, the Party who decides that a Combined Therapy Patent Right should
not be filed or maintained (and who also decides not to reimburse the other
Party for its share of the costs of for a given country shall promptly assign
its rights to the Combined Therapy Patent Right in said country to the Party
(the “Filing Party”) who wishes to file or maintain said Combined Therapy Patent
Right in such country and the Filing Party shall grant, and hereby grants, to
the other Party an irrevocable, perpetual, fully-paid, non-exclusive license,
with the right to grant and authorize sublicenses, under such Combined Therapy
Patent Rights to make, have made, use, sell, offer for sale, import and other
exploit products and services in such country. The Party who does not wish to
file or maintain a Combined Therapy Patent Right in any country shall assist in
the timely provision of all documents required under national provisions to
register said assignment of rights with the corresponding national authorities
at the sole expenses of the Party who wishes to file or maintain such Combined
Therapy Patent Right in that given country. If the Parties cannot agree with
respect to the decision to file or maintain a Combined Therapy Patent Right
within [***] subsequent to the initiation of the Parties’ good faith efforts to
resolve any disagreement, then either Party (whichever files first) shall have
the right to file or maintain any Combined Therapy Patent Right in the names of
both Parties, provided that: (i) any such Combined Therapy Patent Right shall be
jointly owned by the Parties and subject to the freedom to use and operate under
such Combined Therapy Patent Right as set forth in the first sentence of this
Section 6.1(c); (ii) such prosecuting Party obtains the prior consent of the
non-prosecuting Party, which consent shall not be unreasonably withheld or
delayed, and (iii) the non-prosecuting party reimburses the prosecuting party
for its [***] share of the patent costs.

 

(d)                                      Separation of Patent Rights. In order
to more efficiently enable the prosecution and maintenance of the BMS Study
Patent Rights, the Recipient Study Patent Rights and Combined Therapy Patent
Rights relating to Inventions as described above, the Parties will use good
faith efforts to separate BMS Study Patent Rights, the Recipient Study Patent
Rights, Combined Therapy Patent Rights, BMS Independent Patent Rights and the
Recipient Independent Patent Rights into separate patent filings to the extent
possible and without adversely impacting such prosecution and maintenance or the
scope of the protected subject matter.

 

6.2                            Disclosure and Assignment of Inventions;
Ownership of Independent Patent Rights. Each Party shall disclose promptly to
the other Party in writing and on a confidential basis all Inventions, prior to
any public disclosure thereof or filing of Patent Rights therefor and allowing
sufficient time for comment by the other Party. In addition, each Party shall,
and does hereby, assign, and shall cause its Affiliates and contractors to so
assign, to the other Party, without additional compensation, such right, title
and interest in and to any Inventions as well as any Patent Rights and other
intellectual property rights with respect thereto, as is necessary to fully
effect, as applicable, the sole ownership provided for in Sections 6.1(a) and
6.1(b) and the joint ownership provided for in Section 6.1(c). Each Party shall
ensure that each of its employees and contractors conducting activities under
this Agreement is under written obligation to assign all right, title and
interest in and to all Inventions and Study Data and all intellectual property
rights therein to such Party. Except for the license granted in Section 3.1,
nothing in this Agreement shall be construed to grant or transfer to Recipient
any rights in the BMS Independent Patent Rights, which shall be the sole and
exclusive property of BMS, and nothing in this Agreement shall be construed to
grant or transfer to BMS any rights in the Recipient Independent Patent Rights,
all of which shall be the sole and exclusive property of Recipient.

 

6.3                            Infringement of Patent Rights by Third Parties.

 

(a)                                 Notice. Each Party shall promptly notify the
other Party in writing of any Infringement of Combined Therapy Patent Rights, of
which its in-house patent counsel becomes aware.

 

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(b)                                 Infringement of Recipient Study Patent
Rights. For all Infringements of Recipient Study Patent Rights anywhere in the
world, the Recipient shall have the exclusive right to prosecute such
Infringements as it may determine in its sole and absolute discretion, and the
Recipient shall bear all related expenses and retain all related recoveries. BMS
shall reasonably cooperate with the Recipient or its designee (to the extent BMS
has relevant information arising out of this Agreement), at the Recipient’s
request and expense, in any such action.

 

(c)                                  Infringement of BMS Study Patent Rights.
For all Infringements of BMS Study Patent Rights anywhere in the world, BMS
shall have the exclusive right to prosecute such Infringements as it may
determine in its sole and absolute discretion, and BMS shall bear all related
expenses and retain all related recoveries. The Recipient shall reasonably
cooperate with BMS or its designee (to the extent that the Recipient has
relevant information arising out of this Agreement), at BMS’s request and
expense, in any such action.

 

(d)                                 Infringement of Combined Therapy Patent
Rights.

 

(i)                                    With respect to Infringements of Combined
Therapy Patent Rights, the Parties shall mutually agree as to whether to bring
an enforcement action to seek the removal or prevention of such Infringements
and damages therefor and, if so, which Party shall bring such action, with any
costs and expenses relating thereto to be allocated in accordance with
Section 6.3(d)(ii).

 

(ii)                                Regardless of which Party brings an
enforcement action pursuant to Section 6.3(d)(i) or whether the Parties reach
agreement to initiate such an enforcement action, the other Party hereby agrees
to cooperate reasonably in any such action, including, if required, by bringing
a legal action, furnishing a power of attorney or jointing as a plaintiff to
such a legal action. If the Parties mutually agree to bring an enforcement
action, BMS shall be responsible for [***], and the Recipient shall be
responsible for [***], of the reasonable and verifiable costs and expenses
incurred in connection with any such action. If either Party recovers monetary
damages from any Third Party in an action agreed to by the Parties, such
recovery shall be allocated first to the reimbursement of any actual,

 

unreimbursed costs and expenses incurred by the Parties in such litigation
(including, for this purpose, a reasonable allocation of expenses of internal
counsel) pro rata in accordance with the aggregate amounts spent by both
Parties, and any remaining amounts shall be split [***] to the Recipient and
[***] to BMS, unless the Parties agree in writing to a different allocation. If
the Parties do not agree to initiating such an enforcement action, (A) the Party
initiating such enforcement action shall be responsible for the costs and
expenses incurred in connection with such action and shall reimburse the other
Party for the costs the other Party incurs for the assistance and cooperation
requested by such Party and (B) the Party initiating such enforcement action
shall retain all recoveries from such enforcement action. In connection with any
proceeding under this Section 6.3(d), neither Party shall enter into any
settlement without the prior written consent of the other Party.

 

6.4                            Infringement of Third Party Rights.

 

(a)                                 Notice. If the activities relating to the
Combined Therapy Clinical Trial become the subject of a claim of infringement of
a patent, copyright or other proprietary right by a Third Party anywhere in the
world, the Party first having notice of the claim shall promptly notify the
other Party and, without regard to which Party is charged with said infringement
and the venue of such claim, the Parties shall promptly confer to discuss the
claim.

 

(b)                                 Defense. If both Parties are charged with
infringement pursuant to a claim described in Section 6.4(a), each Party shall
have the right to defend itself against such claim and the Parties shall discuss
in good faith defending such claim jointly. If only one Party is charged with
infringement, such Party will have the first right but not the obligation to
defend such claim. If the charged Party does not commence actions to defend such
claim within thirty (30) calendar days after request by the other Party to do
so, then the other Party shall have the right, but not the obligation, to defend
any such claim to the extent such claim pertains to the other Party’s Compound.
In any event, the non-defending Party shall reasonably cooperate with the Party
conducting the defense of the claim and shall have the right to participate with
separate counsel at its own expense, and the defending Party shall consider
comments and suggestions on strategy for defending the action by the
non-defending Party in good faith. The Party defending the claim shall bear the
cost and expenses of the defense of any such

 

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Third Party infringement claim and shall have sole rights to any recovery. If
the Parties jointly defend the claim, the Recipient shall bear [***], and BMS
shall bear [***] of any costs and expenses of the defense of any such Third
Party infringement claim; provided, however, that, notwithstanding the
foregoing, if the claim relates solely to one Party’s Compound, such Party will
bear one hundred percent (100%) of the costs and expenses of the defense of such
claim and shall have the sole right, but not the obligation, to defend, settle
and otherwise handle the disposition of such claim. Neither Party shall enter
into any settlement concerning activities under this Agreement or the Combined
Therapy that affects the other Party’s rights under this Agreement or imposes
any obligations on the other Party, including any admissions of wrongdoing on
behalf of the other Party, without such other Party’s prior written consent, not
to be unreasonably withheld or delayed, except that a Party may settle any claim
that solely relates to its Compound without the consent of the other Party as
long as such other Party’s rights under this Agreement are not adversely
impacted (in which case, it will obtain such other Party’s prior written
consent, not to be unreasonably withheld or delayed). If any claim described in
this Section 6.4(b) is subject to a Party’s indemnification obligations under
Article 11, then Article 11 shall govern such claim and not this Section 6.4(b).

 

6.5                            Combined Therapy Clinical Trial Regulatory
Documentation. Subject to the license and other rights granted by each Party to
the other Party pursuant to this Agreement, the Recipient shall solely own all
right, title and interest in and to the Combined Therapy Clinical Trial
Regulatory Documentation; provided, however, that BMS shall retain sole and
exclusive ownership of any BMS Regulatory Documentation that is submitted with
or referenced in the Combined Therapy Clinical Trial Regulatory Documentation
and that the Recipient shall retain sole and exclusive ownership of any
Recipient Regulatory Documentation that is submitted with or referenced in the
Combined Therapy Clinical Trial Regulatory Documentation. This Section 6.5 is
without limitation of any other disclosure obligations under this Agreement.

 

6.6                            No Other Use. Except as expressly provided in
Section 6.1, the Recipient agrees not to make or file any Patent Rights
application based on or containing BMS Confidential Information, and to give no
assistance to any Third Party for such application without BMS’s prior written
authorization, and BMS agrees not to make or file any Patent Rights application
based on or containing the Recipient’s Confidential Information, and to give no
assistance to any Third Party for such application without the Recipient’s prior
written authorization.

 

6.7                            Joint Research Agreement. The Parties acknowledge
and agree that this Agreement is a “joint research agreement” as defined in 35
USC § 100 (h).

 

ARTICLE 7

 

COSTS AND EXPENSES

 

7.1                            Manufacturing and IP Costs. Expenses incurred as
described in Article 4 (regarding Manufacturing and Supply) and Article 6
(regarding Intellectual Property) shall be borne or shared by the Parties as
provided in such Articles.

 

7.2                            TP Study Costs. For all expenses (other than
those set forth in section 7.1) that are directly attributable or reasonably
allocable to the conduct of the Combined Therapy Clinical Trial: (a) the
Recipient will solely bear all out-of-pocket costs reasonably incurred by the
Recipient (or by BMS pursuant to the following sentence) to Third Parties
(including to CROs, laboratories and clinical sites/IRBs) in connection with the
performance of the Combined Therapy Clinical Trial (“TP Study Costs”), and
(b) each Party shall be solely responsible for all of its own internal costs
(including costs of individual independent contractors) incurred by such Party
or any of its Affiliates. It is not expected that BMS will incur any TP Study
Costs; however, in the event BMS should incur any TP Study Costs in connection
with the conduct of the Combined Therapy Clinical Trial as contemplated by the
budget therefor or as previously agreed to in writing by the Parties, the
Recipient will reimburse BMS for same on a [***] following submission of an
invoice therefor and appropriate supporting documentation.

 

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7.3         Third Party License Payments. If the conduct of the Combined Therapy
Clinical Trial requires a Third Party License Payment with respect to the
manufacture, supply and use of the BMS Study Drug used in the Combined Therapy
Clinical Trial, then BMS shall be responsible for the payment of any such Third
Party License Payment. If the conduct of the Combined Therapy Clinical Trial
requires a Third Party License Payment with respect to the manufacture, supply
and use of the Recipient Study Drug used in the Combined Therapy Clinical Trial,
then Recipient shall be responsible for the payment of any such Third Party
License Payment.

 

ARTICLE 8

 

RECORDS AND STUDY DATA

 

8.1         Records. Each Party shall maintain complete and accurate records of
all work conducted with respect to the Combined Therapy Clinical Trial and of
all results, information, data, data analyses, reports, records, methods,
processes, practices, formulae, instructions, skills, techniques, procedures,
experiences and developments made by or provided to either Party, or by the
Parties together, in the course of such Party(ies)’ efforts with respect to the
Combined Therapy Clinical Trial (including any statistical analysis plan and any
bioanalysis plan to be conducted pursuant to the Protocol or otherwise agreed to
by the Parties) (such results, information, data, data analyses, reports, case
report forms, adverse event reports, trial records, methods, processes,
practices, formulae, instructions, skills, techniques, procedures, experiences,
developments, and the Protocol referred to as the “Study Data”). Such records
shall fully and properly reflect all work done and results achieved in the
performance of the Combined Therapy Clinical Trial in sufficient detail and in
good scientific manner appropriate for patent and regulatory purposes.

 

8.2         Ownership of Study Data. BMS shall own the Study Data to the extent
that it relates exclusively to the BMS Study Drug (“BMS Study Data”), and the
Recipient shall own the Study Data to the extent that it relates exclusively to
the Recipient Study Drug (“Recipient Study Data”). Both Parties shall jointly
own any Study Data that does not relate exclusively to the Recipient Study Drug
or the BMS Study Drug (“Combined Therapy Study Data”). Each Party shall, and
does hereby, assign, and shall cause its Affiliates to so assign, to the other
Party, without additional compensation, such right, title and interest in and to
any Study Data as is necessary to fully effect the foregoing, and agrees to
execute all instruments as may be reasonably necessary to effect same.

 

8.3         Use of Study Data.

 

(a)           Use of a Party’s Own Study Data. BMS may use and analyze the BMS
Study Data for any purpose without obligation or accounting to the Recipient,
who shall hold the BMS Study Data in confidence pursuant to this Agreement. The
Recipient may use and analyze the Recipient Study Data for any purpose without
obligation or accounting to BMS, who shall hold the Recipient Study Data in
confidence pursuant to this Agreement.

 

(b)           Use of Combined Therapy Study Data by BMS. BMS, Ono and their
respective Affiliates and (sub)licensees shall have the right to use and analyze
the Combined Therapy Study Data (i) in connection with the independent
development, commercialization or other exploitation of the BMS Study Drug
(alone or in combination with other drugs and/or other pharmaceutical agents)
and/or for inclusion in the safety database for the BMS Study Drug, in each case
without the consent of, or any obligation to account to, the Recipient, and
(ii) to conduct studies with Samples pursuant to Section 8.5. Subject to
Section 8.5, the results of all such analyses or uses shall be owned by BMS,
including any intellectual property arising out of same, unless the Parties
shall have agreed otherwise in a writing separate from this Agreement. BMS, Ono,
and their respective Affiliates and (sub)licensees shall also be entitled to use
the Combined Therapy Study Data during and following the Term to (1) make
regulatory filings, meet regulatory requirements, and seek approvals for the BMS
Study Drug, either alone or as part of the Combined Therapy, (2) evaluate the
safety and efficacy of the Combined Therapy and the BMS Study Drug, (3) promote
indications based on, and to disseminate, the Combined Therapy Study Data for
the benefit of the BMS Study Drug, either alone or as part of the Combined
Therapy, where permitted by and in accordance with Applicable Law; provided that
nothing in the foregoing is intended or shall be construed as granting BMS any
right or license, expressly or impliedly to make, have made, use, sell, offer
for sale, or import the Recipient Study Drug; and (4) include in Patent Rights
filings made in the course of

 

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the prosecution of BMS Independent Patent Rights that do not Cover both the
composition of matter of the Recipient Study Drug, its manufacture or
formulation, method of use and the BMS Study Drug. The Recipient grants BMS,
Ono, their respective Affiliates and (sub)licensees (of rights to the BMS Study
Drug) a Right of Cross-Reference to the Recipient Regulatory Documentation
Controlled by Recipient for the Recipient Study Drug and the Combined Therapy
Clinical Trial Regulatory Documentation for the Recipient Study Drug or the
Combined Therapy for the sole purpose of enabling BMS, Ono and their Affiliates
and sublicensees to exercise its rights under clause (1) of this Section 8.3(b),
which right shall survive any expiration or termination of this Agreement.

 

(c)           Use of Combined Therapy Study Data by the Recipient. The Recipient
and its Affiliates and licensees shall have the right to use and analyze the
Combined Therapy Study Data (i) in connection with the independent development,
commercialization or other exploitation of the Recipient Study Drug (alone or in
combination with other drugs and/or other pharmaceutical agents) and/or for
inclusion in the safety database for the Recipient Study Drug, in each case
without the consent of, or any obligation to account to, BMS and (ii) to conduct
studies with Samples pursuant to Section 8.5. Subject to Section 8.5, the
results of all such analyses or uses shall be owned by the Recipient, including
any intellectual property arising out of same, unless the Parties shall have
agreed otherwise in writing separate from this Agreement. The Recipient, its
Affiliates and (sub)licensees shall be entitled to use the Combined Therapy
Study Data during and following the Term to (1) make regulatory filings, meet
regulatory requirements and seek approvals for the Recipient Study Drug, either
alone or as part of the Combined Therapy, (2) evaluate the safety and efficacy
of the Combined Therapy and the Recipient Study Drug, (3) promote indications
based on, and to disseminate, the Combined Therapy Study Data for the benefit of
the Recipient Study Drug, either alone or as part of the Combined Therapy, where
permitted by and in accordance with Applicable Law; provided that nothing in the
foregoing is intended or shall be construed as granting the Recipient any right
or license, expressly or impliedly, to make, have made, use, sell, offer for
sale, or import the BMS Study Drug; and (4) and include in Patent Rights filings
made in the course of the prosecution of Recipient Independent Patent Rights
that do not Cover both the composition of matter of the BMS Study Drug, its
manufacture or formulation, method of use and the Recipient Study Drug. BMS
grants the Recipient, its Affiliates and licensees of the Recipient Study Drug a
Right of Cross-Reference to the relevant Regulatory Documentation Controlled by
BMS for the BMS Study Drug for the sole purpose of enabling the Recipient, its
Affiliates and (sub)licensees to exercise its rights under clause (1) of this
Section 8.3(c) (for clarity, such Right of Cross-Reference shall not extend to
any Ono-controlled Regulatory Documentation) in all countries and territories of
the world, which right shall survive any expiration or termination of this
Agreement.

 

(d)           Biomarker/Dx Agent Development. Each Party may use and disclose to
a Third Party the Combined Therapy Study Data and its Compound’s Study Data,
under obligations of confidentiality consistent with this Agreement, to develop
and commercialize a biomarker or diagnostic test for use with its Compound
(including without limitation another combination therapy involving its
Compound) and/or the Combined Therapy, and, unless otherwise mutually agreed by
the Parties in writing, will own any intellectual property arising out of the
work funded or conducted by it with or through such Third Party. Each Party
shall grant, and hereby grants, to the other Party a worldwide, perpetual,
irrevocable, fully paid-up, royalty-free non-exclusive license, with the right
to grant and authorize sublicenses, under such intellectual property and data to
develop and commercialize biomarkers and/or diagnostic tests for use with the
Combined Therapy. The Parties will discuss in good faith any opportunities to
jointly participate in the development of any such biomarker or diagnostic test
for use with the Combined Therapy.

 

(e)           No Other Uses. All other uses of Combined Therapy Study Data (by
either Party), Recipient Study Data (by BMS) and BMS Study Data (by the
Recipient) are limited solely to those permitted by this Agreement, and neither
Party may use such Study Data for any other purpose without the consent of the
other Party during and after the Term.

 

8.4         Access to Study Data. Subject to the provisions of Sections 8.1,
each Party shall have access to all Combined Therapy Study Data, Recipient Study
Data and BMS Study Data (including de-identified patient records). The relevant
Party shall make such Study Data in its possession available to the

 

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other Party within a reasonable period, not to exceed [***], after such Study
Data is available to or generated by the applicable Party.

 

8.5         Samples.

 

(a)             Samples shall be jointly owned by the Parties (to the extent not
owned by the patient and/or the clinical trial site). Any such Samples shall be
collected in accordance with the Protocol and applicable ICFs. Except as set
forth in the Protocol, neither Party shall be permitted to use such Samples for
any purpose without the prior written consent of the other Party, which consent
shall not be unreasonably withheld if such use is directed to the Combined
Therapy and with the terms of such use to be set forth in a written agreement
between the Parties setting forth the Samples to be used, and any appropriate
terms/restrictions on such use. For clarity, Replimune shall have the right,
without further consent of BMS, to use and study any such Samples as set forth
in the Protocol, it being understood that if the Protocol does not reference
specific assays to be utilized in the analysis of any such Samples and such
analysis will be in the discretion of Replimune. Except for intellectual
property pertaining solely to the [***] (which shall be owned by BMS), any data
and intellectual property arising out of such Sample use shall be owned by the
Party conducting such study using same, provided that, to the extent that any
such data or intellectual property relates solely to the Combined Therapy (or
biomarkers solely for use with the Combined Therapy), shall be considered
Combined Therapy Study Data, Combined Therapy Inventions and/or Combined Therapy
Patent Rights, as the case may be. All Samples, including Samples for PK and ADA
serum analysis will be stored for future use in the Recipient’s sample
repository, unless the Parties mutually agree that BMS would store such samples,
provided that, if the Party holding the Samples determines that it no longer has
a use for the Samples and the other Party determines that it does, then the
Samples shall, subject to Applicable Law and the terms of the signed ICFs, be
transferred to the other Party and may be used solely thereafter by the other
Party. If neither Party has any further use for the Samples, then the remaining
Samples will be destroyed pursuant to the respective Party’s standard operating
procedures for sample retention and destruction, subject to the terms of and
permission(s) granted in the informed consent forms signed by the subjects
contributing the Samples in the Combined Therapy Clinical Trial.

 

(b)              If required by a Regulatory Authority or necessary as part of
the Protocol or related bioanalysis plan, BMS will arrange for the Recipient to
use BMS’s preferred Third Party vendor(s), at the Recipient’s expense, for
bioanalytical work of Samples from Combined Therapy Clinical Trial subjects on
the BMS Study Drug. Such vendor(s) will provide the results of their
bioanalytical work of such Samples to the Recipient and BMS, which results will
be included in the final clinical study report, along with the bioanalytical
work of the Recipient Study Drug and BMS Study Drug performed by or on behalf of
the Recipient. For the avoidance of doubt, all bioanalytical results for the BMS
Study Drug and the Recipient Study Drug are deemed Study Data. All data derived
pursuant to the Protocol from such Samples is deemed Study Data.

 

ARTICLE 9

 

CONFIDENTIALITY

 

9.1          Nondisclosure of Confidential Information.

 

(a)           Any Confidential Information relating to the BMS Study Drug (in
connection with the Combined Therapy Clinical Trial), Recipient Study Drug or
the conduct of the Combined Therapy Clinical Trial previously disclosed by the
Parties pursuant to the RP-1 Agreement shall now be Confidential Information for
purposes of this Agreement and the Parties shall treat it as such in accordance
with the terms hereof. All written, visual, oral and electronic data,
information, know-how or other proprietary information or materials, both
technical and non-technical, disclosed by one Party to the other Party pursuant
to this Agreement, and disclosed in the manner specified herein, that (a) if in
tangible form, is labeled in writing as “proprietary” or “confidential” (or
similar reference), or (b) if in oral or visual form, is identified as
proprietary or confidential or for internal use only at the time of disclosure
or within thirty (30) calendar days thereafter shall be “Confidential
Information” of the disclosing Party, and all Study Data and Inventions shall be
the Confidential Information of the Party (or Parties) owning such Study Data or

 

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Invention (as provided in Section 8.2 with regard to Study Data and Section 6.1
with regard to Inventions). For purposes of this Agreement, regardless of which
Party discloses such Confidential Information to the other, (i) all Recipient
Study Inventions, Recipient Technology and Recipient Regulatory Documentation
shall be Confidential Information of the Recipient and BMS shall be the
receiving Party, and (ii) all BMS Study Inventions, BMS Technology, and BMS
Regulatory Documentation shall be Confidential Information of BMS and the
Recipient shall be the receiving Party.

 

(b)           The Parties agree that the terms of this Agreement shall be
treated as Confidential Information of both Parties, and thus may be disclosed
only as permitted by Section 9.3. Except as required by Applicable Law, each
Party agrees not to issue any press release or public statement disclosing
information relating to this Agreement or the transactions contemplated hereby
or the terms hereof without the prior written consent of the other Party, except
as permitted by Sections 9.3 and 9.6(b).

 

(c)           Except to the extent expressly authorized in this Section 9.1 and
Sections 9.2, 9.3 and 9.6 below, or as otherwise agreed in writing by the
Parties, each Party agrees that, for the Term and for a period of [***]
thereafter, it shall (A) keep confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than as expressly provided for
in this Agreement any Confidential Information of the other Party (including
information relating to this Agreement or the transactions contemplated hereby
or the terms hereof), (B) treat the other Party’s Confidential Information with
the same degree of care the receiving Party uses for its own confidential
information but in no event with less than a reasonable degree of care; and
(C) reproduce the disclosing Party’s Confidential Information solely to the
extent necessary or reasonably useful to accomplish the receiving Party’s
obligations under this Agreement or exercise the receiving Party’s rights to use
and disclose such Confidential Information as expressly provided for in this
Agreement, with all such reproductions being considered the disclosing Party’s
Confidential Information, provided that, with respect to BMS Confidential
Information that was received as confidential information from Ono, the
obligations of confidentiality and nonuse shall continue until BMS has obtained
Ono’s written consent that the same may be freely used. Notwithstanding anything
to the contrary in this Section 9.1, and subject to Section 8.3, the receiving
Party may disclose the disclosing Party’s Confidential Information to its
employees, consultants, agents or permitted (sub)licensees solely on a
need-to-know basis for the purpose of fulfilling the receiving Party’s
obligations under this Agreement or exercising the receiving Party’s rights to
use and disclose such Confidential Information as expressly provided for in this
Agreement; provided, however, that (1) any such employees, consultants, agents
or permitted (sub)licensees are bound by obligations of confidentiality and
non-use at least as restrictive as those set forth in this Agreement, and
(2) the receiving Party remains liable for the compliance of such employees,
consultants, agents or permitted (sub)licensees with such obligations. Each
receiving Party acknowledges that in connection with its and its representatives
examination of the Confidential Information of the disclosing Party, the
receiving Party and its representatives may have access to material, non-public
information, and that the receiving Party is aware, and will advise its
representatives who are informed as to the matters that are the subject of this
Agreement, that State and Federal laws, including United States securities laws,
may impose restrictions on the dissemination of such information and trading in
securities when in possession of such information. Each receiving Party agrees
that it will not, and will advise its representatives who are informed as to the
matters that are the subject of this Agreement to not, purchase or sell any
security of the disclosing Party on the basis of the Confidential Information to
the extent such Confidential Information constitute material nonpublic
information about the disclosing Party or such security.

 

(d)           Combined Therapy Study Data shall be treated as Confidential
Information of each Party and shall not be disclosed to Third Parties except to
the extent it falls within the exceptions set forth in Section 9.2 below, is
authorized under this Section 9.1 or Section 9.3, is required to be filed with a
Regulatory Authority or included in a product’s label or package insert, is
reasonably necessary to be disclosed in order for a Party to exercise its rights
under Section 8.3(b) or 8.3(c) or it is disclosed pursuant to Section 9.5.

 

9.2          Exceptions. The obligations in Section 9.1 shall not apply with
respect to any portion of Confidential Information that the receiving Party can
demonstrate by contemporaneous tangible records or other competent proof:

 

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(a)           was already known to the receiving Party (or its Affiliates),
other than under an obligation of confidentiality, either (i) at the time of
disclosure by the disclosing Party, or (ii) if applicable, at the time that it
was generated hereunder, whichever ((i) or (ii)) is earlier;

 

(b)           was generally available to the public or otherwise part of the
public domain either (i) at the time of its disclosure to the receiving Party,
or (ii) if applicable, at the time that it was generated hereunder, whichever
((i) or (ii)) is earlier;

 

(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 (or its Affiliates), other
than under an obligation of confidentiality, by a Third Party who had no
obligation to the Party owning or Controlling the information not to disclose
such information to others; or

 

(e)           was independently discovered or developed by the receiving Party
(or its Affiliates) without the use of, or reference to, the Confidential
Information belonging to the disclosing Party.

 

9.3          Authorized Disclosure. Notwithstanding any other provision of this
Agreement, each Party may disclose Confidential Information belonging to the
other Party to the extent such disclosure is reasonably necessary in the
following instances:

 

(a)           filing or prosecuting Patent Rights pursuant to Section 6.1(c);

 

(b)           prosecuting or defending litigation;

 

(c)           complying with Applicable Law or the rules or regulations of any
securities exchange on which such Party’s stock is listed;

 

(d)           disclosure, in connection with the performance of this Agreement,
to Affiliates, permitted (sub)licensees, contractors, IRBs, CROs, academic
institutions, consultants, agents, investigators, and employees and contractors
engaged by study sites and investigators involved with the Combined Therapy
Clinical Trial, each of whom prior to disclosure must be bound by terms of
confidentiality and non-use at least as protective of Confidential Information
as those set forth in this Article 9;

 

(e)           disclosure of the Combined Therapy Study Data, Combined Therapy
Inventions and Combined Therapy Patent Rights to Regulatory Authorities in
connection with the development and obtaining of regulatory approval of the
Combined Therapy, the Recipient Study Drug or the BMS Study Drug;

 

(f)            disclosure of relevant safety information contained within the
Combined Therapy Study Data to investigators, IRBs and/or ethics committees and
Regulatory Authorities that are involved in other clinical trials of the
Recipient Study Drug with respect to the Recipient, and the BMS Study Drug with
respect to BMS, and, in the event of a Material Safety Issue, to Third Parties
that are collaborating with the Recipient or BMS, respectively in the conduct of
such other clinical trials of the Recipient Study Drug or the BMS Study Drug, in
each case solely to the extent necessary for the conduct of such clinical trials
and/or to comply with Applicable Law and regulatory requirements; and

 

(g)           subject to a [***] advance written notice to BMS, in
communications with [***], under confidentiality provisions as least as
protective of Confidential Information as those of this Agreement; provided that
with respect to [***] such disclosure shall be limited to the terms and
conditions of this Agreement and the Combined Therapy Study Data.

 

Notwithstanding the foregoing, if a Party is required or otherwise intends to
make a disclosure of any other Party’s Confidential Information pursuant to
Section 9.3(b) and/or Section 9.3(c), it shall give advance notice to such other
Party of such impending disclosure and endeavor in good faith to secure

 

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confidential treatment of such Confidential Information and/or reasonably assist
the Party that owns such Confidential Information in seeking a protective order
or other confidential treatment.

 

9.4         Disclosure to Ono.  Notwithstanding any other provision of this
Agreement, BMS shall be entitled to disclose to Ono (a) the existence (but not
the terms) of this Agreement, the Combined Therapy Clinical Trial and the
Protocol, and (b) any other Recipient Confidential Information necessary for BMS
to fulfill its obligations to Ono under the Ono-BMS Agreements; provided that
Ono is under confidentiality obligations at least as restrictive as set forth
herein. BMS shall be free to disclose to Ono and permit Ono to use the BMS Study
Data and the Combined Therapy Study Data as BMS may determine (so long as such
use is consistent with BMS’s permitted uses under Section 8.3(b)).

 

9.5         Press Releases and Publications.

 

(a)           The Parties shall jointly agree to the content and timing of all
public communications with respect to this Agreement, press releases, Q&As, and
the content of, and wording for, any listing of the Combined Therapy Clinical
Trial required to be listed on a public database or other public registry such
as www.clinicaltrials.gov). For clarity, if either Party terminates this
Agreement pursuant to Section 12.4, the Parties shall mutually agree upon any
external communication related to such termination, which shall not include the
rationale for such termination unless (and to the extent) mutually agreed by the
Parties. Notwithstanding the foregoing in this Section 9.5(a), either Party
shall be permitted to publicly disclose information that such Party determines
in good faith is necessary to be disclosed to comply with Applicable Law or the
rules or regulations of any securities exchange on which such Party’s stock may
be listed, or pursuant to an order of a court or governmental entity.

 

(b)           The Recipient and BMS agree to collaborate to publicly disclose,
publish or present (i) top-line results from the Combined Therapy Clinical
Trial, limited if possible to avoid jeopardizing the future publication of the
Study Data at a scientific conference or in a scientific journal, solely for the
purpose of disclosing, as soon as reasonably practicable, the safety or efficacy
results and conclusions that are material to either Party under applicable
securities laws, and (ii) the conclusions and outcomes (the “Results”) of the
Combined Therapy Clinical Trial at a scientific conference as soon as reasonably
practicable following the database lock date for such Combined Therapy Clinical
Trial, subject in the case of (ii) to the following terms and conditions. The
Party proposing to disclose, publish or present the Results shall deliver to the
other Party a copy of the proposed disclosure, publication or presentation at
least [***] before submission to a Third Party. The reviewing Party shall
determine whether any of its Confidential Information that may be contained in
such disclosure, publication or presentation should be modified or deleted,
whether to file a patent application on any Recipient Study Invention (solely
with respect to the Recipient) or BMS Study Invention (solely with respect to
BMS) or Combined Therapy Invention disclosed therein. The disclosure,
publication or presentation shall be delayed for an additional [***] (i.e., a
total of [***] from the initial proposal) if the reviewing Party reasonably
requests such extension to allow time for the preparation and filing of relevant
patent applications consistent with the terms of this Agreement. If the
reviewing Party reasonably requests modifications to the disclosure, publication
or presentation to prevent the disclosure of Confidential Information of the
reviewing Party (other than the Results or Study Data), the publishing Party
shall edit such publication to prevent the disclosure of such information prior
to submission of the disclosure, publication or presentation. In the event of a
disagreement as to content, timing and/or venue or forum for any disclosure,
publication or presentation of the Results, such dispute (a “Publication
Dispute”) shall be referred to the Executive Officers (or their respective
designees); provided that, in the absence of agreement after such good faith
discussions, and upon expiration of the additional [***] period, (A) academic
collaborators or clinical trial sites engaged by the Recipient in connection
with the performance of the Combined Therapy Clinical Trial may publish Combined
Therapy Study Data obtained by such academic collaborator or clinical trial site
solely to the extent that such ability to publish such Combined Therapy Study
Data is set forth in an agreement between the Recipient and such academic
collaborator or clinical trial site relating to the conduct of Combined Therapy
Clinical Trial and (B) the publishing Party may proceed with the disclosure,
publication or presentation provided that such disclosure, publication or
presentation is consistent with its internal publication guidelines and
customary industry practices for the publication of similar data and does not
disclose the Confidential Information of the other Party (other than the Results
or Study Data). Authorship of any publication shall be determined based on the
accepted standards used in peer-reviewed academic journals at the time of the
proposed disclosure,

 

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publication or presentation. The Parties agree that they shall make reasonable
efforts to prevent publication of a press release that could jeopardize the
future publication of Study Data at a scientific conference or in a scientific
journal but in no way will this or any other provision of this Agreement
supersede the requirements of any Applicable Law or the rules or regulations of
any securities exchange or listing entity on which a Party’s stock is listed
(including any such rule or regulation that may require a Party to make public
disclosures about interim results of the Combined Therapy Clinical Trial).
Notwithstanding the foregoing, nothing herein shall prevent or restrict Ono from
making any disclosures of published Study Data disclosed to it by BMS pursuant
to Section 9.4 or of the existence of this Agreement, in each case in order for
Ono to comply with requirements of Applicable Law, the rules or regulations of
any securities exchange or listing entity on which its stock may be traded or
pursuant to an order of a court or governmental entity to publicly disclose the
existence of the Agreement and the Study Data, provided that if any such
disclosure is made by Ono it will only disclose the minimum amount of
information necessary to achieve compliance and will provide the Recipient with
reasonable advance notice of such disclosure.

 

(c)           The Recipient agrees to include in all permitted press releases,
presentations and publications it makes related to the Combined Therapy Clinical
Trial specific mention, if applicable, of the BMS Study Drug and the support and
involvement of BMS. BMS agrees to include in all permitted press releases,
presentations and publications it makes related to the Combined Therapy Clinical
Trial specific mention, if applicable, of the Recipient Study Drug and the
support and involvement of the Recipient.

 

9.6          Compliance with Sunshine Laws.

 

(a)           For purposes of compliance with reporting obligations under
Sunshine Laws, as between the Parties, the Recipient/the Recipient represents
that it is not, as of the Effective Date, subject to reporting obligations under
the Sunshine Laws. Therefore, as between the Parties, BMS will report payments
or other transfers of value (“POTV”) made by the Recipient or the CRO related to
the conduct of the Combined Therapy Clinical Trial and any applicable associated
contractor engagements as required under the Sunshine Laws for the Combined
Therapy Clinical Trial. BMS shall request delayed publication for any reported
POTV for studies sponsored by the Recipient as permitted under the Sunshine Laws
and if consistent with BMS’s normal business practices. In the event that the
Recipient becomes responsible for reporting POTV for studies sponsored by it in
a given country during the Term, the Recipient shall provide written
notification to BMS and the Parties will meet to confer to discuss how they wish
to handle reporting thereafter. Interpretation of the Sunshine Laws for purposes
of reporting any POTV by a Party shall be in such Party’s sole discretion so
long as the interpretation complies with Applicable Law.

 

(b)           The Recipient (i) will provide (to the extent in the possession of
the Recipient), or will utilize Commercially Reasonable Efforts to obligate and
ensure that each CRO and other applicable Third Party contractors for the
Combined Therapy Clinical Trial provides, BMS with any information requested by
BMS as BMS may reasonably determine is necessary for BMS to comply with its
reporting obligations under Sunshine Laws (with such amounts paid to, or at the
direction of, healthcare providers, teaching hospitals and/or any other persons
for whom POTVs must be reported under Sunshine Laws to be reported to BMS within
a reasonable time period specified by BMS) and (ii) will reasonably cooperate
with, and will utilize Commercially Reasonable Efforts to obligate and ensure
that each CRO and other applicable Third Party contractors for the Combined
Therapy Clinical Trial reasonably cooperates with, BMS in connection with its
compliance with such Sunshine Laws. The form in which the Recipient provides any
such information shall be mutually agreed but sufficient to enable BMS to comply
with its reporting obligations and BMS may disclose any information that it
believes is necessary to comply with Sunshine Laws. Without limiting the
foregoing, BMS shall have the right to allocate POTVs in connection with this
Agreement in any required reporting under Sunshine Laws in accordance with its
normal business practices. These obligations shall survive the expiration and
termination of this Agreement to the extent necessary for BMS to comply with
Sunshine Laws. The Recipient shall not be required to provide any information to
BMS that is subject to disclosure pursuant to the Recipient’s own obligations
under the Sunshine Laws.

 

(c)               For purposes of this Section 9.7, “Sunshine Laws” shall mean
Applicable Laws requiring collection, reporting and disclosure of POTVs to
certain healthcare providers, entities and

 

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individuals. These Applicable Laws may include relevant provisions of the
Patient Protection and Affordable Health Care Act of 2010 and implementing
regulations thereunder.

 

9.7         Destruction of Confidential Information.     Upon expiration or
termination of the Agreement, the receiving Party shall, upon request by the
other Party, immediately destroy or return all of the other Party’s Confidential
Information relating solely to its Compound as monotherapy (but not to the
Combined Therapy or the Combined Therapy Study Data) in its possession;
provided, however, that the receiving Party shall be entitled to retain one
(1) copy of Confidential Information solely for record-keeping purposes and
shall not be required to destroy any Confidential Information required, or
reasonably necessary, to be retained for any clinical trial activities that
continue after expiration or termination, or off-site computer files created
during automatic system back up which are subsequently stored securely by the
receiving Party.

 

9.8          Nonsolicitation of Employees.    Each Party agrees that, during the
[***] thereafter, neither it nor any of its Affiliates shall recruit, solicit or
induce any employee of the other Party directly involved in the development or
other activities conducted by the other Party under this Agreement to terminate
his or her employment with such other Party and become employed by or consult
for such other Party, whether or not such employee is a full-time employee of
such other Party, and whether or not such employment is pursuant to a written
agreement or is at-will. For purposes of the foregoing, “recruit”, “solicit” or
“induce” shall not be deemed to mean (a) circumstances where an employee of one
Party initiates contact with the other Party or any of its Affiliates with
regard to possible employment, or (b) general solicitations of employment not
specifically targeted at employees of a Party or any of its Affiliates,
including responses to general advertisements.

 

ARTICLE 10

 

REPRESENTATIONS AND WARRANTIES

 

10.1        Authority and Binding Agreement. Each Party represents and warrants
to the other Party that (a) it has the corporate power and authority and the
legal right to enter into this Agreement and perform its obligations hereunder,
(b) it has taken all necessary corporate action on its part required to
authorize the execution and delivery of the Agreement and the performance of its
obligations hereunder, and (c) the Agreement has been duly executed and
delivered on behalf of such Party and constitutes a legal, valid and binding
obligation of such Party that is enforceable against it in accordance with its
terms subject to bankruptcy, insolvency, reorganization, arrangement,
winding-up, moratorium, and similar laws of general application affecting the
enforcement of creditors’ rights generally, and subject to general equitable
principles, including the fact that the availability of equitable remedies, such
as injunctive relief or specific performance, is in the discretion of the court.

 

10.2        No Conflicts. Each Party represents and warrants to the other Party
that, to the best of its knowledge, it has not entered as of the Effective Date,
and shall not enter, into any agreement with any Third Party that is in conflict
with the rights granted to the other Party under this Agreement, and has not
taken any action that would in any way prevent it from granting the rights
granted to the other Party under this Agreement, or that would otherwise
materially conflict with or adversely affect the rights granted to the other
Party under this Agreement.

 

10.3        Litigation. Each Party represents and warrants to the other Party,
to the best of its knowledge as of the Effective Date, it is not aware of any
pending or threatened litigation (and has not received any communication) that
alleges that its activities related to this Agreement have violated, or that by
conducting the activities as contemplated in this Agreement it would violate,
any of the intellectual property rights of any other Person (after giving effect
to the license grants in this Agreement).

 

10.4        No Adverse Proceedings. Each Party represents and warrants to the
other Party that, except as otherwise notified to the other Party, as of the
Effective Date, there is not pending or, to the knowledge of such Party,
threatened, against such Party, any claim, suit, action or governmental
proceeding that would, if adversely determined, materially impair the ability of
such Party to perform its obligations under this Agreement.

 

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10.5        Consents. Each Party represents and warrants to the other Party
that, to the best of its knowledge, all necessary consents, approvals and
authorizations of all regulatory and governmental authorities and other Persons
(a) required as of the Effective Date to be obtained by such Party in connection
with the execution and delivery of this Agreement have been obtained (or will
have been obtained prior to such execution and delivery) and (b) required to be
obtained by such Party in connection with the performance of its obligations
under this Agreement have been obtained or will be obtained prior to such
performance.

 

10.6        No Debarment. Each Party hereby certifies to the other that it has
not used, and will not use the services of any person disqualified, debarred,
banned, subject to debarment or convicted of a crime for which a person could be
debarred by the FDA under 21 U.S.C. 335a, as amended (or subject to a similar
sanction of any other Regulatory Authority), in any capacity in connection with
any of the services or work provided under the Combined Therapy Clinical Trial
and that this certification may be relied upon in any applications to the FDA or
any other Regulatory Authority. It is understood and agreed that this
certification imposes a continuing obligation upon each Party to notify the
other promptly of any change in the truth of this certification. Upon request by
a Party, the other Party agrees to provide a list of persons used to perform the
services or work provided under any activities conducted for or on behalf of
such Party or any of its Affiliates pursuant to this Agreement who, within the
five (5) years preceding the Effective Date, or subsequent to the Effective
Date, were or are convicted of one of the criminal offenses required by 21
U.S.C. 335a, as amended, to be listed in any application for approval of an
abbreviated application for drug approval.

 

10.7        Compliance with Applicable Law. Each Party represents and warrants
to the other Party that it shall comply with all Applicable Law of the country
or other jurisdiction, or any court or agency thereof, applicable to the
performance of its activities hereunder or any obligation or transaction
hereunder, including those pertaining to the production and handling of drug
products, such as those set forth by the Regulatory Authorities, as applicable,
and the applicable terms of this Agreement in the performance of its obligations
hereunder.

 

10.8        Affiliates. Each Party represents and warrants to the other Party
that, to the extent the intellectual property, Regulatory Documentation or
Technology licensed by it hereunder are Controlled by its Affiliates or a Third
Party, it has the right to use, and has the right to grant (sub)licenses to the
other Party to use, such intellectual property, Regulatory Documentation or
Technology in accordance with the terms of this Agreement.

 

10.9        Ethical Business Practices. Each Party represents and warrants to
the other Party that neither it nor its Affiliates will make any payment, either
directly or indirectly, of money or other assets, including the compensation
such Party derives from this Agreement (collectively a “Payment”), to government
or political party officials, officials of International Public Organizations,
candidates for public office, or representatives of other businesses or persons
acting on behalf of any of the foregoing (collectively “Officials”) where such
Payment would constitute violation of any law, including the Foreign Corrupt
Practices Act of 1977, 15 U.S.C. §§ 78dd-1, et seq. In addition, regardless of
legality, neither it nor its Affiliates will make any Payment either directly or
indirectly to Officials if such Payment is for the purpose of improperly
influencing decisions or actions with respect to the subject matter of this
Agreement. All activities will be conducted in compliance with the U.S. False
Claims Act and the U.S. Anti-Kickback Statute.

 

10.10      Accounting. Each Party represents and warrants to the other Party
that all transactions under the Agreement shall be properly and accurately
recorded in all material respects on its books and records and that each
document upon which entries in such books and records are based is complete and
accurate in all material respects.

 

10.11      Single Agent Compound Safety Issues. Each Party represents and
warrants that, to the best of its knowledge as of the Effective Date, it is not
aware of any material safety or toxicity issues with respect to its Single Agent
Compound that are not reflected in the investigator’s brochure for its Single
Agent Compound existing as of the Effective Date.

 

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10.12                 Compliance with Licensor Agreements. Each Party will use,
and will cause its Affiliates to use, Commercially Reasonable Efforts to comply
with its obligations under any agreements entered into by it or its Affiliates
with a Third Party under which it is licensed any intellectual property rights
or confidential information relating to a Compound (and not to voluntarily
terminate same) to the extent necessary for the Combined Therapy Clinical Trial
to be conducted and completed in accordance with the terms of this Agreement and
for the other Party to receive the rights and benefits provided to it under this
Agreement.

 

10.13                 DISCLAIMER OF WARRANTY. THE EXPRESS REPRESENTATIONS AND
WARRANTIES STATED IN THIS ARTICLE 10 ARE IN LIEU OF, AND THE PARTIES DO HEREBY
DISCLAIM, ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED OR
STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR USE, AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY
RIGHTS.

 

ARTICLE 11

 

INDEMNIFICATION

 

11.1                        BMS Indemnification. BMS hereby agrees to defend,
hold harmless and indemnify (collectively, “Indemnify”) the Recipient, its
Affiliates, and its and their agents, directors, officers, employees and
subcontractors (the “Recipient Indemnitees”) from and against any and all
liabilities, expenses and/or losses, including reasonable legal expenses and
attorneys’ fees (collectively “Losses”) resulting from Third Party suits,
claims, actions and demands (each, a “Third Party Claim”) to the extent that
they arise or result from (a) the negligence or intentional misconduct of any
BMS Indemnitee or any (sub)licensee of BMS conducting activities on behalf of
BMS under this Agreement, (b) any breach by BMS of any provision of this
Agreement, (c) any injury (other than resulting from known adverse effects) to a
subject in the Combined Therapy Clinical Trial to the extent caused by the BMS
Study Drug, or (d) the use by BMS, its Affiliates, contractors or (sub)licensees
of Combined Therapy Study Data, BMS Study Data, BMS Study Inventions, BMS Study
Patent Rights, Combined Therapy Inventions and Combined Therapy Patent Rights
(other than with respect to Third Party Claims that are covered under
Section 6.4); but excluding, in each case ((a) through (d)), any such Losses to
the extent arising or resulting from a cause or event for which the Recipient is
obligated to Indemnify the BMS Indemnitees pursuant to Section 11.2.

 

11.2                        Recipient Indemnification. The Recipient hereby
agrees to Indemnify BMS, its Affiliates, and its and their agents, directors,
officers, employees and subcontractors (the “BMS Indemnitees”) from and against
any and all Losses resulting from Third Party Claims to the extent that they
arise or result from (a) the negligence or intentional misconduct of any
Recipient Indemnitee or any (sub)licensee of the Recipient conducting activities
on behalf of the Recipient under this Agreement, (b) any breach by the Recipient
of any provision of this Agreement, (c) any injury to a subject in the Combined
Therapy Clinical Trial not caused by the BMS Study Drug, or (d) the use by the
Recipient, its Affiliates, contractors or (sub)licensees of Combined Therapy
Study Data, Recipient Study Data, Recipient Study Inventions, Recipient Study
Patent Rights, Combined Therapy Inventions and Combined Therapy Patent Rights
(other than with respect to Third Party Claims that are covered under
Section 6.4); but excluding, in each case ((a) through (d)), any such Losses to
the extent arising or resulting from a cause or event for which BMS is obligated
to Indemnify the Recipient Indemnitees pursuant to Section 11.1.

 

11.3                        Indemnification Procedure. Each Party’s agreement to
Indemnify the other Party is conditioned on the performance of the following by
the Party seeking indemnification: (a) providing written notice to the
Indemnifying Party of any Loss and/or Third Party Claim of the types set forth
in Section 11.1 and 11.2 promptly, and in any event within sixty (60) calendar
days, after the Party seeking indemnification has knowledge of such Loss and/or
Third Party Claim; provided that, any delay in complying with the requirements
of this clause (a) will only limit the Indemnifying Party’s obligation to the
extent of the prejudice caused to the Indemnifying Party by such delay,
(b) permitting the Indemnifying Party to assume full responsibility to
investigate, prepare for and defend against any such Loss and/or Third Party
Claim, (c) providing reasonable assistance to the Indemnifying Party, at the
Indemnifying Party’s expense, in the

 

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investigation of, preparation for and defense of any Loss and/or Third Party
Claim, and (d) not compromising or settling such Loss and/or Third Party Claim
without the Indemnifying Party’s written consent, such consent not to be
unreasonably withheld or delayed.

 

11.4                        Separate Defense of Claims. In the event that the
Parties cannot agree as to the application of Sections 11.1 and/or 11.2 to any
particular Loss, the Parties may conduct separate defenses of such Loss. Each
Party further reserves the right to claim indemnity from the other in accordance
with Sections 11.1 and/or 11.2 upon resolution of the underlying claim,
notwithstanding the provisions of Section 11.3(b).

 

11.5                        Insurance. Each Party shall maintain commercially
reasonable levels of insurance or other adequate and commercially reasonable
forms of protection or self-insurance to satisfy its indemnification obligations
under this Agreement. Each Party shall provide the other Party with written
notice at least thirty (30) calendar days prior to the cancellation, non-renewal
or material change in such insurance or self-insurance which would materially
adversely affect the rights of the other Party hereunder. The maintenance of any
insurance shall not constitute any limit or restriction on damages available to
a Party under this Agreement.

 

11.6                        LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE
LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL
DAMAGES, INCLUDING LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT
AND/OR SUCH PARTY’S PERFORMANCE HEREUNDER, REGARDLESS OF ANY NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES AND REGARDLESS OF THE CAUSE OF ACTION (WHETHER IN
CONTRACT, TORT, BREACH OF WARRANTY OR OTHERWISE). NOTHING IN THIS SECTION 11.6
IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF A
PARTY UNDER SECTIONS 11.1 OR 11.2 IN RELATION TO, OR DAMAGES AVAILABLE FOR,
BREACHES OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9 OR FOR A PARTY’S GROSS
NEGLIGENCE OR WILLFUL MISCONDUCT.

 

ARTICLE 12

 

TERM AND TERMINATION

 

12.1                        Term. This Agreement shall be effective as of the
Effective Date and, unless earlier terminated pursuant to this Section 12.1,
Sections 12.2, 12.3 or 12.4 or any other termination right expressly stated in
this Agreement, shall continue in effect until completion of the Combined
Therapy Clinical Trial by all centers participating in the Combined Therapy
Clinical Trial, delivery of all Study Data, including all completed case report
forms, all final analyses and all final clinical study reports contemplated by
the Combined Therapy Clinical Trial to both Parties, and the completion of any
statistical analyses and bioanalyses contemplated by the Protocol or otherwise
agreed to by the Parties to be conducted under this Agreement (the “Term”).
Notwithstanding the foregoing, either Party shall have the right to immediately
terminate this Agreement if the Parties do not agree to a draft Protocol
pursuant to Section 2.1(a) within [***] after the Effective Date on written
notice to the other Party within [***] after the end of such [***] period;
provided that Recipient shall reimburse BMS its cost of Manufacture and supply
(including shipping, taxes and duty, if applicable) for any BMS Study Drug
supplied to Recipient for the Combined Therapy Clinical Trial prior to such
termination.

 

12.2                        Termination for Material Breach.

 

(a)                                 Notice and Cure Period. If a Party (the
“Breaching Party”) is in material breach of its obligations under this
Agreement, the other Party (the “Non-Breaching Party”) shall have the right to
give the Breaching Party notice specifying the nature of such material breach.
The Breaching Party shall have a period of [***] after receipt of such notice to
cure such material breach (the “Cure Period”) in a manner reasonably acceptable
to the Non-Breaching Party. For the avoidance of doubt, this provision is not
intended to restrict in any way either Party’s right to notify the other Party
of any other breach or to demand the cure of any other breach.

 

(b)                                 Termination Right. The Non-Breaching Party
shall have the right to terminate this Agreement, upon written notice, in the
event that the Breaching Party has not cured such material breach within the
Cure Period, provided, however, that if such breach is capable of cure but
cannot be

 

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cured within the Cure Period, and the Breaching Party commences actions to cure
such material breach within the Cure Period and thereafter diligently continue
such actions, the Breaching Party shall have an additional [***] to cure such
breach. If a Party contests such termination pursuant to the dispute resolution
procedures under Section 13.3, such termination shall not be effective until a
conclusion of the dispute resolution procedures in Section 13.3, as applicable,
resulting in a determination that there has been a material breach that was not
cured within the Cure Period (which Cure Period shall be tolled for the period
from notice of such dispute until resolution of such dispute pursuant to
Section 13.3 or abandonment of such dispute by the disputing Party).

 

12.3                        Termination for Bankruptcy. Either Party may
terminate this Agreement if, at any time, the other Party shall file in any
court or agency pursuant to any statute or regulation of any state, country or
jurisdiction, a petition in bankruptcy or insolvency or for reorganization or
for an arrangement or for the appointment of a receiver or trustee of such other
Party or of such other Party’s assets, or if the other Party proposes a written
agreement of composition or extension of its debts, or if the other Party shall
be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed or stayed within [***]
after the filing thereof, or if the other Party will propose or be a party to
any dissolution or liquidation, or if the other Party shall make an assignment
for the benefit of its creditors.

 

12.4                        Termination due to Material Safety Issue; Clinical
Hold.

 

(a)                                 Either Party shall have the right to
terminate this Agreement immediately (after meeting and discussing with the
other Party in good faith as described in the following sentence) upon written
notice if it deems it necessary to protect the safety, health or welfare of
subjects enrolled in the Combined Therapy Clinical Trial due to the existence of
a Material Safety Issue. In the event of a termination due to a Material Safety
Issue, prior to the terminating Party providing written notice, each Party’s
safety committee shall, to the extent practicable, meet and discuss in good
faith the safety concerns raised by the terminating Party and consider in good
faith the input, questions and advice of the non-terminating Party, but should
any dispute arise in such discussion, the dispute resolution processes set forth
in Section 13.3 shall not apply to such dispute and the terminating Party shall
have the right to issue such notice and such termination shall take effect
without the Parties first following the procedures set forth in Section 13.3.

 

(b)                                 If a Clinical Hold with respect to either
the BMS Study Drug or the Recipient Study Drug should arise at any time after
the Effective Date, the Parties will meet and discuss the basis for the Clinical
Hold, how long the Clinical Hold is expected to last, and how they might address
the issue that caused the clinical hold. If, after [***] of discussions
following the Clinical Hold, either Party reasonably concludes that the issue
adversely impacts the Combined Therapy Clinical Trial and is not solvable or
that unacceptable and material additional costs/delays have been and/or will
continue to be incurred in the conduct of the Combined Therapy Clinical Trial,
then such Party may immediately terminate this Agreement.

 

12.5                        Effect of Termination. Upon expiration or
termination of this Agreement, (a) the licenses granted to the Recipient to
conduct the Combined Therapy Clinical Trial in Section 3.1 (and any sublicenses
granted under Section 3.2) shall terminate, and (b) the Parties shall use
reasonable efforts to wind down activities under this Agreement in a reasonable
manner and avoid incurring any additional expenditures or non-cancellable
obligations; provided that, in the case of termination pursuant to Section 12.4,
the Recipient may continue to dose subjects enrolled in the Combined Therapy
Clinical Trial through completion of the Protocol if dosing is required by the
applicable Regulatory Authority(ies) and/or Applicable Law. Any such wind-down
activities will include the return to BMS, or destruction, of all BMS Study Drug
provided to the Recipient and not consumed in the Combined Therapy Clinical
Trial, except in the event that the Recipient terminates this Agreement pursuant
to Section 12.2 or 12.3, in which case the Recipient shall continue to have the
right to use any BMS Study Drug provided to Recipient for the conduct of the
Combined Therapy Clinical Trial.

 

12.6                        Survival. The following Articles and Sections of
this Agreement and all definitions relating thereto shall survive any expiration
or termination of this Agreement for any reason: Section 2.1(b), Section 2.4,
Section 4.5, Sections 5.1(e)-(h), Section 5.1(j), Section 5.1(k),
Section 5.1(o), Article 6 (“Intellectual Property”), Article 7 (“Costs and
Expenses), Article 8 (“Records and Study Data”), Article 9

 

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(“Confidentiality”); Article 10 (“Representations and Warranties”), Article 11
(“Indemnification”), Section 12.5 (“Effect of Termination”), Section 12.6
(“Survival”), Section 13.1 (“Entire Agreement”), Section 13.2 (“Governing Law”),
Section 13.3 (“Dispute Resolution”), Section 13.4 (“Injunctive Relief”),
Section 13.6 (“Notices”), Section 13.7 (“No Waiver, Modifications”),
Section 13.8 (“No Strict Construction”), Section 13.9 (“Independent
Contractor”), Section 13.10 (“Assignment, Licenses”), Section 13.11
(“Headings”), Section 13.13 (“Severability”), Section 13.15 (“No Benefit to
Third Parties”), and Section 13.16 (“Construction”).

 

ARTICLE 13

 

MISCELLANEOUS

 

13.1                        Entire Agreement. The Parties acknowledge that this
Agreement shall govern all activities of the Parties with respect to the
Combined Therapy Clinical Trial from the Effective Date forward. This Agreement,
including the Exhibits hereto and together with the Supply and Quality
Documentation, sets forth the complete, final and exclusive agreement between
the Parties concerning the subject matter hereof and supersedes all prior
agreements and understandings between the Parties with respect to such subject
matter. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties with respect to such subject matter other than as are set forth in
this Agreement. All Exhibits attached hereto are incorporated herein as part of
this Agreement.

 

13.2                        Governing Law. This Agreement shall be governed and
construed in accordance with the internal laws of the State of Delaware, USA,
excluding any choice of law rules that may direct the application of the laws of
another jurisdiction.

 

13.3                        Dispute Resolution.

 

(a)                                      The Parties’ Designated Clinical
Contacts (for clinical and regulatory matters) and the Parties Designated Supply
Contacts (for supply matters) shall attempt in good faith to resolve any dispute
or concern that either Party may bring to the other Party’s attention.

 

(b)                                      In the event of any dispute,
controversy or claim arising out of, relating to or in connection with any
provision of this Agreement (each a “Dispute”), other than a Publication Dispute
or a dispute as to whether a Material Safety Issue exists, that cannot be
resolved by the applicable Designated Contacts of each Party after a period of
[***], then upon the request of either Party by written notice, the Parties
shall refer such Dispute to the Executive Officers. This Agreement shall remain
in effect during the pendency of any such dispute. In the event that no
resolution is made by the Executive Officers (or their designee) in good faith
negotiations within [***] after such referral to them, then:

 

(i)                                    if such Dispute constitutes an
Arbitration Matter, such Dispute shall be resolved through arbitration in
accordance with the remainder of this Section 13.3; provided, however, that with
respect to any such Arbitration Matter Dispute that relates to a matter
described in Section 13.4, either Party shall have the right to seek an
injunction or other equitable relief without waiting for the expiration of such
[***] period;

 

(ii)                                if such Dispute constitutes a Publication
Dispute, the specific dispute resolution processes contained in
Section 9.6(b) will apply;

 

(iii)                            if such Dispute regards the supply, quality or
compliance with specifications of the Recipient Study Drug, the Recipient shall
have the final say regarding such Dispute; provided that (A) the Recipient shall
have no authority to amend, change or waive compliance with this Agreement,
which matters may be approved only by the written consent of both Parties,
(B) all determinations made by the Recipient shall be consistent with the terms
of this Agreement;

 

(iv)                             if such Dispute regards the supply, quality or
compliance with specifications of the BMS Study Drug, BMS shall have the final
say regarding such Dispute; provided that

 

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(A) BMS shall have no authority to amend, change or waive compliance with this
Agreement, which matters may be approved only by the written consent of both
Parties, (B) all determinations made by BMS shall be consistent with the terms
of this Agreement.

 

If a Dispute that constitutes an Arbitration Matter remains unresolved after
escalation to the Executive Officers as described above, either Party may refer
such matter to arbitration as described herein. Any arbitration of an
Arbitration Matter under this Agreement shall be shall be conducted under the
auspices of the American Arbitration Association by a panel of three
(3) arbitrators pursuant to that organization’s Commercial Arbitration
Rules then in effect.

 

(c)                                       The fees and expenses of the
arbitrators shall be borne in equal shares by the Parties. Each Party shall bear
the fees and expenses of its legal representation in the arbitration. The
arbitral tribunal shall not reallocate either the fees and expenses of the
arbitrators or of the Parties’ legal representation. The arbitration shall be
held in New York, New York, which shall be the seat of the arbitration. The
language of the arbitration shall be English.

 

13.4                        Injunctive Relief. Notwithstanding anything herein
to the contrary, a Party may seek an injunction or other injunctive relief from
any court of competent jurisdiction in order to prevent immediate and
irreparable injury, loss or damage on a provisional basis. For the avoidance of
doubt, if either Party (a) discloses Confidential Information of the other Party
other than as permitted under Article 9, (b) uses (in the case of the Recipient)
the BMS Study Drug or BMS Technology or (in the case of BMS) the Recipient Study
Drug or Recipient Technology in any manner other than as expressly permitted
under this Agreement or (c) otherwise is in material breach of this Agreement
and such material breach could cause immediate harm to the value of the
Recipient Study Drug (by the Recipient) or the BMS Study Drug (by BMS), the
other Party shall have the right to seek an injunction or other equitable relief
precluding the other Party from continuing its activities related to the
Combined Therapy Clinical Trial without waiting for the conclusion of the
dispute resolution procedures under Section 13.3.

 

13.5                        Force Majeure. The Parties shall be excused from the
performance of their obligations under this Agreement (other than the payment of
monies owed to the other Party) to the extent that such performance is prevented
by force majeure and the non-performing Party promptly provides notice of the
prevention to the other Party. Such excuse shall be continued so long as the
condition constituting force majeure continues and the nonperforming Party takes
reasonable efforts to remove the condition. For purposes of this Agreement,
force majeure shall mean acts of God, strikes or other concerted acts of
workers, civil disturbances, fires, earthquakes, acts of terrorism, floods,
explosions, riots, war, rebellion, sabotage or failure or default of public
utilities or common carriers or similar conditions beyond the control of the
Parties.

 

13.6                        Notices. Any notice required or permitted to be
given under this Agreement shall be in writing, shall specifically refer to this
Agreement and shall be deemed to have been sufficiently given for all purposes
if such notice is timely and is: (a) mailed by first class certified or
registered mail, postage prepaid, return receipt requested, (b) sent by express
delivery service, or (c) personally delivered. Unless otherwise specified in
writing, the mailing addresses of the Parties shall be as described below.

 

 

For the Recipient:

Replimune Inc.

 

 

18 Commerce Way

 

 

Wolburn, MA 10801

 

 

Attention: Rob Coffin, CEO

 

 

 

 

For BMS:

Bristol-Myers Squibb Company

 

 

Route 206 and Province Line Road

 

 

Princeton, NJ 08543-4000

 

 

Attention: VP, Business Development

 

 

 

 

With a copy to:

Bristol-Myers Squibb Company

 

 

Route 206 and Province Line Road

 

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Princeton, NJ 08543-4000

 

 

Attention: VP & Assistant General Counsel, Licensing and

 

 

Business Development

 

Any such communication shall be deemed to have been received when delivered. It
is understood and agreed that this Section 13.6 is not intended to govern the
day-to-day business communications necessary between the Parties in performing
their duties, in due course, under the terms of this Agreement.

 

13.7                        No Waiver; Modifications. It is agreed that no
waiver by a Party hereto of any breach or default of any of the covenants or
agreements herein set forth shall be deemed a waiver as to any subsequent and/or
similar breach or default. No amendment, modification, release or discharge
shall be binding upon the Parties unless in writing and duly executed by
authorized representatives of both Parties.

 

13.8                        No Strict Construction. This Agreement has been
prepared jointly and shall not be strictly construed against either Party. No
presumption as to construction of this Agreement shall apply against either
Party with respect to any ambiguity in the wording of any provision(s) of this
Agreement irrespective of which Party may be deemed to have authored the
ambiguous provision(s).

 

13.9                        Independent Contractor. The Parties are independent
contractors of each other, and the relationship between the Parties shall not
constitute a partnership, joint venture or agency. Neither Party shall be the
agent of the other or have any authority to act for, or on behalf of, the other
Party in any matter.

 

13.10                 Assignment; Licensees.

 

(a)                                           Assignment. Neither Party may
assign or transfer this Agreement or any rights or obligations hereunder without
the prior written consent of the other Party, except that a Party may make such
an assignment without the other Party’s consent (i) to an Affiliate, (ii) to a
Third Party that merges with, consolidates with or acquires substantially all of
the assets or voting control of the assigning Party or (iii) to a Third Party
that acquires all the rights of the assigning Party to the Recipient Study Drug,
in the case of the Recipient, or the BMS Study Drug, in the case of BMS. If
assigned or transferred to an Affiliate, the assigning/transferring Party shall
remain jointly and severally responsible and liable with the assignee/transferee
Affiliate for the assigned rights and/or obligations. If assigned to a Third
Party, any permitted successor or assignee of rights and/or obligations
hereunder shall, in a writing to the other Party, expressly assume performance
of such rights and/or obligations. Any assignment or attempted assignment by any
Party in violation of the terms of this Section 13.10(a) shall be null and void
and of no legal effect.

 

(b)                                           Licensees. If a Party grants a
third party a license (other than a license solely to make a product for a Party
and other than any license rights granted to Ono for the Ono Territory) to
develop and commercialize its Single Agent Compound on a worldwide basis or in
any geographic region and/or for all purposes or a limited field, (a
“Licensee”), such Party will obtain the Licensee’s agreement to abide by the
terms of this Agreement as and to the extent necessary in order for its
obligations hereunder to be fulfilled in the same manner as the licensing Party;
and in such event the licensing Party may exercise its rights granted hereunder
(including rights to use Study Data and practice Inventions) through the
Licensee.

 

13.11                 Headings. The captions to the several Sections and
Articles hereof are not a part of this Agreement, but are included merely for
convenience of reference only and shall not affect its meaning or
interpretation.

 

13.12                 Counterparts. This Agreement may be executed in two (2) or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one (1) and the same instrument. This Agreement may be
executed by facsimile or electronic (e.g., pdf) signatures and such signatures
shall be deemed to bind each Party hereto as if they were original signature.

 

13.13                 Severability. If any provision of this Agreement is held
to be illegal, invalid or unenforceable under any present or future law, and if
the rights or obligations of a Party under this Agreement will not be materially
and adversely affected thereby, (a) such provision shall be fully severable,
(b) this Agreement shall be construed and enforced as if such illegal, invalid
or unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and

 

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effect and shall not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom and (d) in lieu of such illegal, invalid
or unenforceable provision, there shall be added automatically as a part of this
Agreement a legal, valid and enforceable provision as similar in terms to such
illegal, invalid or unenforceable provision as may be possible and reasonably
acceptable to the Parties.

 

13.14                 Further Assurance. Each Party shall duly execute and
deliver, or cause to be duly executed and delivered, such further instruments
and do and cause to be done such further acts and things, including the filing
of such assignments, agreements, documents and instruments, as may be necessary
or as the other Party may reasonably request in order to perfect any license,
assignment or other transfer or any properties or rights under, or pursuant, to
this Agreement.

 

13.15                 No Benefit to Third Parties. The representations,
warranties and agreements set forth in this Agreement are for the sole benefit
of the Parties and their successors and permitted assigns, and they shall not be
construed as conferring any rights on any other parties.

 

13.16                 Construction.

 

(a)                                           General. Except as otherwise
explicitly specified to the contrary, (i) references to a Section, Article or
Exhibit means a Section or Article of, or Exhibit to, this Agreement and all
subsections thereof, unless another agreement is specified, (ii) references to a
particular statute or regulation include all rules and regulations promulgated
thereunder and any successor statute, rules or regulations then in effect, in
each case including the then-current amendments thereto, (iii) words in the
singular or plural form include the plural and singular form, respectively,
(iv) the terms “including,” “include(s),” “such as,” and “for example” used in
this Agreement mean including the generality of any description preceding such
term and will be deemed to be followed by “without limitation”, and (v) the
words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words
refer to this Agreement. No presumption as to construction of this Agreement
shall apply against either Party with respect to any ambiguity in the wording of
any provision(s) of this Agreement irrespective of which Party may be deemed to
have authored the ambiguous provision(s).

 

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

 

[Signature page follows]

 

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

 

Replimune Inc.

 

Bristol-Myers Squibb Company

 

 

 

 

 

 

By:

/s/ Robert Coffin

 

By:

/s/ Fouad Namouni

 

 

 

 

 

Name:

Robert Coffin

 

Name:

Fouad Namouni, MD

 

 

 

 

 

Title:

CEO

 

Title:

Head of Oncology Development

 

 

 

 

 

Date:

12th April 2019

 

Date:

April 11, 2019

 

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APPENDIX A

 

DRAFT PROTOCOL SUMMARY

 

[***]

 

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