Exhibit 10.26

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

EXECUTION COPY

COLLABORATION, DEVELOPMENT AND LICENSE AGREEMENT

THIS COLLABORATION, DEVELOPMENT AND LICENSE AGREEMENT (the “Agreement”) is made
and entered into as of September 28, 2016 (the “Effective Date”), by and between
TESARO, Inc., a Delaware corporation with a place of business at 1000 Winter
Street, Suite 3300, Waltham, Massachusetts, United States of America, 02451
(“TESARO Inc.”), TESARO Development Ltd., a Bermuda corporation with a place of
business at Clarendon House, 2 Church Street, Hamilton HM 11 Bermuda (“TSRO
Ltd.”, and together with “TESARO Inc.”, “TESARO”) and Zai Lab (Shanghai) Co.,
Ltd. having its principal office at 1043 Halei Road, Building 8, Suite 502,
Pudong, Shanghai, P.R. China, 201203 (“ZAI”).  TESARO and ZAI are sometimes
referred to herein individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, TESARO is developing a proprietary PARP inhibitor, Niraparib, and owns
or controls certain patents, know-how and other intellectual property rights
with respect to such compound; and

WHEREAS, ZAI is a company focusing on the development of innovative drug
candidates, including immuno-oncology-focused drug-candidates, primarily in
China; and

WHEREAS, ZAI desires to obtain an exclusive license from TESARO to develop and
commercialize niraparib in China, and TESARO is willing to grant such a license
to ZAI, all on the terms and conditions set forth herein;

WHEREAS, the parties desire to potentially co-market niraparib in China and to
provide TESARO the right to exercise such co-marketing rights on the terms and
conditions set forth herein; and

WHEREAS, TESARO desires to obtain an option to obtain an exclusive license from
ZAI to research, develop, manufacture, and commercialize certain immune-oncology
assets being developed by ZAI outside of China, and ZAI is willing to grant such
an option on TESARO, all on the terms and conditions set forth herein.

NOW, THEREFORE in consideration of the foregoing and the mutual agreements set
forth below, the Parties agree as follows.

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.

 

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1.1 “Affiliate” of a Person means any other Person which (directly or
indirectly) is controlled by, controls or is under common control with such
Person, for so long as such control exists.  For the purposes of this
definition, the term “control” (including, with correlative meanings, the terms
“controlled by” and “under common control with”) as used with respect to a
Person means (a) direct or indirect ownership of voting securities entitled to
cast more than fifty percent (50%) (or, if less than 50%, the maximum ownership
interest permitted by Applicable Law) of the votes in the election of directors
of such entity, or (b) the possession, directly or indirectly, of the power to
direct the management and policies of such entity, whether through ownership of
voting securities, by contract or otherwise.

1.2 “Applicable Law” means all applicable laws, statutes, rules, regulations,
ordinances and other pronouncements having the effect of law of any federal,
national, multinational, state, provincial, county, city or other political
subdivision, agency or other body, domestic or foreign.

1.3 “AZ Agreements” means the following agreements between TESARO and
AstraZeneca UK Limited (“AZ”): the Patent License Agreement dated October 4,
2012, between AZ (the Institute of Cancer Research) and TESARO; and the Patent
License Agreement dated October 4, 2012, between AZ (University of Sheffield)
and TESARO.

1.4 “Business Day” or “business day” means a day other than Saturday, Sunday or
any day on which commercial banks located in Shanghai, China or New York City,
New York, U.S. (as applicable) are authorized or obligated by Applicable Law to
close.

1.5 “Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31.

1.6 “Calendar Year” means each successive period of twelve (12) months
commencing on January 1 and ending on December 31.

1.7 “CDE” means the Chinese Center for Drug Evaluation.

1.8 “CFDA” means the China Food and Drug Administration, or any successor agency
with a similar scope of responsibility regarding the regulation of human
pharmaceutical products in China.

1.9 “China” means mainland China, Hong Kong and Macau.

1.10 “Commercialization” or “Commercialize” means all activities directed to
marketing, distributing, detailing or selling a Licensed Product (as well as
importing and exporting activities in connection therewith), including all
activities directed to obtaining pricing approvals.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.11 “Commercially Reasonable Efforts” means the performance of obligations or
tasks in a manner consistent with the reasonable practices of companies in the
biopharmaceutical industry having similar financial resources for the
Development or Commercialization (as applicable) of a product having similar
technical and regulatory factors and similar market potential, profit potential
and strategic value, and that is at a similar stage in its Development or
product life cycle as the Licensed Product, in each case based on conditions
then prevailing and without regard to any competitive internal program of
Licensee. Commercially Reasonable Efforts requires that the Party (a) promptly
assign responsibility for such obligations to specific employees who are held
accountable for progress and monitoring such progress on an ongoing basis, (b)
set and consistently seek to achieve specific and meaningful objectives for
carrying out such obligations, and (c) consistently make and implement decisions
and allocate adequate resources designed to advance progress with respect to
such obligations.

1.12 “Confidential Information” means all information, including trade secrets,
processes, formulae, Data, know-how, improvements, inventions, chemical or
biological materials, assays, techniques, marketing plans, strategies, customer
lists, or other information that has been disclosed by or on behalf of one Party
to the other Party under this Agreement, regardless of whether any of the
foregoing are marked “confidential” or “proprietary” or communicated in oral,
written, graphic, or electronic form, or by visual inspection.

1.13 “Controlled” or “Controls”, when used in reference to any particular
subject matter including Patents, know-how, tangible materials or other
intellectual property rights, means the legal authority or right of a Party to
grant a license or sublicense to such subject matter to another Party, or to
otherwise provide such other Party the right to access and use such subject
matter, whether arising by ownership, license, or other authorization, without
breaching the terms of any written agreement with a Third Party under which such
Party first acquired rights to such subject matter, or misappropriating the
proprietary or trade secret information of a Third Party.

1.14 “Cover,” “Covered” or “Covering” means, with respect to a Patent, that, but
for rights granted to a Person under such Patent, the practice by such Person of
an invention claimed in such Patent would infringe a Valid Claim included in
such Patent, or in the case of a Patent that is a patent application, would
infringe a Valid Claim in such patent application if such claim were to issue in
a patent as then prosecuted.

1.15 “Data” means pre-clinical, clinical, chemical, manufacturing and analytical
data and any other data and information generated or resulted from the
Development or Commercialization of the Licensed Compounds or Licensed Products.

1.16 “Development” means, with respect to a Licensed Product, all processes and
activities that are reasonably required to obtain Regulatory Approval of such
Licensed Product, including, without limitation, toxicology, pharmacology and
other pre-clinical efforts, test method development and stability testing,
statistical analysis, clinical studies and regulatory activities.  When used as
a verb, “Develop” means to engage in Development.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.17 “Dollar(s)” or “$” means the lawful currency of the United States.

1.18 “Executive Officer” means, (a) in the case of TESARO, TESARO’s Chief
Executive Officer; and (b) in the case of ZAI, ZAI’s Chief Executive Officer. 

1.19 “FDA” means the U.S. Food and Drug Administration, or any successor agency
of the U.S. government with a similar scope of responsibility regarding the
regulation of human pharmaceutical products.

1.20 “Field” means the treatment, diagnosis and prevention of any diseases or
conditions in humans, other than the treatment, diagnosis and prevention of
prostate cancer. 

1.21 “First Commercial Sale” means, with respect to any Licensed Product, the
first sale of such Licensed Product by ZAI or its Affiliates or sublicensees to
an unrelated Third Party in the ZAI Territory after Regulatory Approval of such
Licensed Product has been granted in the ZAI Territory.  For clarity, First
Commercial Sale does not include the supply or transfer of Licensed Product to
an Affiliate or sublicensee or for clinical trials, compassionate use or sales
made on a named-patient basis. 

1.22 “Follow-on Compound” means a Licensed Compound other than Niraparib.

1.23 “GCP” means the Good Clinical Practice for Drugs (i.e. 药物临床试验质量管理规范)
 promulgated by CFDA effective as of September 1, 2003, together with any
guidelines and/or implementation rules issued by CFDA in connection thereto, in
each case as amended from time to time.

1.24 “Government Official” means: (a) any officer or employee of a government or
any department, agency or instrument of a government; (b) any person acting in
an official capacity for or on behalf of a government or any department, agency,
or instrument of a government; (c) any officer or employee of a company or
business owned in whole or part by a government; (d) any officer or employee of
a public international organization such as the World Bank or United Nations;
(e) any officer or employee of a political party or any person acting in an
official capacity on behalf of a political party; and/or (f) any candidate for
political office; who, when such Government Official is acting in an official
capacity, or in an official decision-making role, has responsibility for
performing regulatory inspections, government authorizations or licenses, or
otherwise has the capacity to make decisions with the potential to affect the
business of either of the Parties.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.25 “Indication” means, with respect to a Licensed Compound or Licensed
Product, the use of that Licensed Compound or Licensed Product for the
treatment, prevention, mitigation or cure of any cancer with a particular organ
of origin.  Indications will be deemed the same for purposes of this Agreement
if the subject cancers have the same organ of origin even if they are, for
example, of a different histologic or genetic subtype or line of therapy (e.g.,
breast cancer, 1st line and 2nd line therapies for ovarian cancer), and will be
deemed different if the subject cancers have different organs of origin (e.g.,
breast cancer and ovarian cancer).  Among non-solid tumor cancers, Indications
for leukemia, lymphoma and multiple myeloma, but not their subtypes or lines of
therapy, shall be considered different Indications. 

1.26 “Invention” means any and all inventions and improvements, whether or not
patentable, that are conceived or reduced to practice or otherwise made or
discovered by or on behalf of a Party (and/or its Affiliates) (whether alone or
jointly) in the performance of its obligations, or the exercise of its rights,
under this Agreement, including but not limited to, processes, methods,
compositions of matter, formula, formulations, articles of manufacture,
discoveries or findings, compounds, products, biological materials, cell lines,
samples of assay components, media, designs, ideas, programs, software models,
algorithms, developments, experimental works, compilations of data, in each case
relating to Licensed Compound and Licensed Products.

1.27 “Joint Invention” means any Invention invented, made or discovered jointly
by both Parties.

1.28 “Licensed Compound” means TESARO’s proprietary PARP inhibitor known as
Niraparib, having chemical structure set forth in Exhibit A, and any
pharmaceutically acceptable salt, polymorph, crystal form, prodrug or solvate
thereof.    

1.29 “Licensed Product” means any pharmaceutical product containing the Licensed
Compound, in all forms, presentations, formulations and dosage forms, for use in
the Field.    

1.30 “Merck Agreement” means that certain License Agreement between TESARO and
Merck, Sharp & Dohme Corp. (“Merck”), dated May 22, 2012, as amended from time
to time.

1.31 “NDA” means a new drug application or marketing authorization application
filed with the applicable Regulatory Authority in a country or jurisdiction,
which application is required for marketing approval for a Licensed Product in
the Field in such country or jurisdiction.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.32  “Net Sales” means, with respect to any Licensed Product, the amount
invoiced by ZAI, its Affiliates or sublicensees for the sales of such Licensed
Product to a Third Party in the ZAI Territory less:

 

(a) trade and quantity discounts other than early payment cash discounts;

(b) returns, rebates, chargebacks and other allowances;

(c) retroactive price reductions that are actually allowed or granted; 

(d) sales commissions  paid to Third Party distributors and/or selling agents;

(e) deductions to gross invoice price of Product imposed by Regulatory
Authorities or other governmental entities;

(f) a fixed amount equal to three percent (3%) of the amount invoiced to cover
bad debt, early payment cash discounts, transportation and insurance and custom
duties; and

(g) the standard inventory cost of devices or delivery systems used for
dispensing or administering Product.

If a Licensed Product is sold as part of a combination that (i) contains the
Licensed Compound and at least one additional therapeutically active ingredient
that is not a Licensed Compound; or (ii) is product consisting of one or more
separate drugs, devices, tests, kits or biological products and sold together
with a Licensed Product in a single package or as a unit (a “Combination
Product”), the Net Sales of such Licensed Product for the purpose of calculating
royalties owed under this Agreement for sales of such Licensed Product, shall be
determined as follows: first, determine the actual Net Sales of such Combination
Product (using the above provisions) and then such amount shall be multiplied by
the fraction A/(A+B), where A is the average gross selling price in the
applicable country of the Licensed Compound sold separately, if sold separately,
in the same formulation and dosage, and B is the sum of the average gross
selling prices in the applicable country of each other active ingredient, drug,
device, test, kit or biological product in the Combination Product sold
separately, if sold separately, in the same formulation, dosage or unit
quantity.  If any active ingredient, drug, device, test, kit or biological
product in the Combination Product is not sold separately in the relevant
formulation, dosage or unit quantity, Net Sales shall be calculated by
multiplying actual Net Sales of such Combination Product by the fraction A/C
where A is the average gross selling price in the applicable country of such
Licensed Compound sold separately in the same formulation and dosage and C is
the average gross selling price in the applicable country of such Combination
Product.  If neither the Licensed Compound nor any other active ingredient,
drug, device, test, kit or biological product in the Combination Product is sold
separately in the relevant formulation, dosage or unit quantity, the adjustment
to Net Sales shall be determined by the Parties in good faith to reasonably
reflect the fair market value of the contribution of the Licensed Compound in
the Combination Product to the total fair market value of such Combination
Product.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.33 “Patents” means all of the following, whether existing as of the Effective
Date or during the Term, anywhere in the world: (a) patents and patent
applications, (b) all priority applications, provisionals, divisionals,
continuations, and continuations-in-part of any of the foregoing, and (c) all
patents issuing on any of the foregoing patent applications, together with all
inventor’s certificates, substitutions, validations, registrations, reissues,
renewals, reexaminations, confirmations, supplementary protection certificates,
and extensions of any of (a), (b) or (c).

1.34 “Person” means any individual, firm, corporation, partnership, limited
liability company, trust, business trust, joint venture company, governmental
authority, association or other entity.

1.35 “Phase 3 Clinical Trial” means a clinical trial of a Licensed Product in
human patients with a defined dose or a set of defined doses designed to
ascertain efficacy and safety of such Licensed Product for the purpose of
enabling the preparation and submission of NDA to the competent Regulatory
Authorities, as further defined in 21 C.F.R. 312.21(c), as amended from time to
time, or the corresponding foreign regulations. 

1.36 “Regulatory Approval” means all approvals, including if required by
Applicable Law, pricing approvals, necessary for the manufacture, marketing,
importation, exportation and sale of a Licensed Product in the ZAI Territory,
which may include, without limitation, satisfaction of all applicable regulatory
and notification requirements.

1.37 “Regulatory Authority” means any federal, national, supranational, state,
provincial or local regulatory agency, department, bureau or other governmental
authority, including, without limitation, the CDE and the CFDA, that has
authority over the manufacture, Development, Commercialization or other use or
exploitation (including the granting of Regulatory Approval) of any Licensed
Product in any applicable regulatory jurisdiction.

1.38 “Regulatory Materials” means materials developed or compiled in preparation
for Regulatory Authority meetings, regulatory applications, submissions,
dossiers, notifications, registrations, Regulatory Approvals and/or other
filings made to or with, or other approvals granted by, a Regulatory Authority
that are necessary or reasonably desirable for the Development, manufacture,
market, sale, or Commercialization of a Licensed Product in a particular
regulatory jurisdiction.

1.39 “Sole Invention” means any Invention invented or discovered solely by or on
behalf of a Party following the Effective Date, including by its employees,
contractors and/or agents.

1.40 “Subcontractor” means a Third Party engaged by ZAI for the purpose of
conducting clinical Development for Licensed Products, contract manufacturing,
toxicology testing and other related Development Activities, solely at the
direction, and on behalf of, ZAI.

1.41 “TESARO IP” means TESARO Know-How and TESARO Patents.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.42 “TESARO Know-How” means all technical information, data and know-how
Controlled by TESARO or its Affiliates as of the Effective Date or during the
Term (including, without limitation, all biological, chemical, pharmacological,
toxicological or clinical know-how, Data and trade secrets) that are reasonably
necessary for the Development, manufacture or Commercialization of the Licensed
Compound or Licensed Product in the ZAI Territory.  TESARO Know-How shall also
include the (a) intangible knowledge and information conveyed to ZAI as set
forth in Section 4.1 and (b) TESARO’s right and interest in and to any Joint
Inventions.  TESARO Know-How does not include TESARO Patents.    

1.43 “TESARO Patents” means all Patents Controlled by TESARO or its Affiliates
as of the Effective Date or during the Term that relate to the ZAI Territory and
that Covers (a) the compositions of matter of the Licensed Compound or Licensed
Product; (b) methods or processes directed to the manufacture of the Licensed
Compound or Licensed Product; or (c) methods of use, administration or
formulation of the Licensed Compound or Licensed Product, including without
limitation, the Patents that are listed in Exhibit B hereto.  TESARO Patents
shall also include TESARO’s rights and interest in and to any Joint Patents.

1.44 “TESARO Territory” means all countries and territories in the world other
than those countries and territories included in the ZAI Territory.

1.45 “Territory” means (a) with respect to TESARO, the TESARO Territory and
(b) with respect to ZAI, the ZAI Territory.

1.46 “Third Party” means any Person other than: ZAI, TESARO, and their
respective Affiliates.

1.47 “United States” or “U.S.” means the United States of America and its
territories and possessions (including, without limitation, Puerto Rico).

1.48 “Upstream Agreements”  means the AZ Agreements and the Merck Agreement.

1.49 “Upstream Licensors” means Astra Zeneca and Merck.

1.50 “Valid Claim” means a claim of (a) an issued and unexpired patent, which
claim has not been held invalid or unenforceable by a court or other government
agency of competent jurisdiction from which no appeal can be or has been taken
and has not been held or admitted to be invalid or unenforceable through
re-examination or disclaimer, opposition procedure, nullity suit or otherwise,
or (b) a pending patent application; provided, however, that if a claim of a
pending patent application shall not have issued within seven (7) years after
the earliest filing date from which such claim takes priority, such claim shall
no longer constitute a Valid Claim for the purposes of this Agreement unless and
until a patent issues with such claim. 

1.51 “ZAI Territory” means China.

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Exhibit 10.26

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.52 Additional Definitions.  The following table identifies the location of
definitions set forth in various Sections of the Agreement:

 

 

Defined Terms

Section

Alliance Managers

3.7

Claim

12.1

Development Plan

5.2

Disclosing Party

11.1

Excluded Claim

14.3

Force Majeure

15.3

ICC

14.2

Infringement

10.3(a)

Joint Patents

10.1(a)

Joint Steering Committee or JSC

3.1

Pharmacovigilance Agreement

5.7

Prior CDA

11.6

Receiving Party

11.1

Remedial Action

5.8

Royalty Term

8.3(b)

Term

13.1

Working Team

3.7

2. LICENSE GRANT

2.1 License to ZAI.  TESARO hereby grants to ZAI an exclusive (but subject to
TESARO’s retained right under Section 2.2 below), royalty bearing and
sublicenseable (in accordance with Section 2.3 below) license under the TESARO
IP to Develop, make, have made, use, offer for sale, sell, have sold, import and
otherwise Commercialize the Licensed Compound and Licensed Products in the Field
in the ZAI Territory.  

2.2 Retained Rights.  Subject to the terms and conditions of this Agreement,
TESARO retains:  (a) the right to practice the TESARO IP within the scope of the
license granted to ZAI under Section 2.1 to perform TESARO’s obligations under
this Agreement; (b) the right to practice and license the TESARO IP outside the
scope of the license granted to ZAI under Section 2.1. 

 

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2.3 Sublicense.  ZAI shall have the right to grant sublicenses, under the
license granted by TESARO to ZAI under Section 2.1 to its Affiliates,
subcontractors and other Third Parties; provided, that TESARO provides its prior
written consent to such sublicense granted to any Third Parties, such consent
not to be unreasonably withheld, conditioned or delayed; and provided further,
that a sublicense to an Affiliate shall not require TESARO’s consent only for so
long as such Affiliate remains an Affiliate of ZAI.  Each sublicense agreement
shall be consistent with, and shall be subject to, the terms and conditions of
this Agreement, and ZAI shall remain responsible for the performance of its
obligations under this Agreement, regardless of whether ZAI may have delegated
those obligations to its sublicensees.  ZAI shall, within thirty (30) days after
granting any sublicense, notify TESARO of the grant of such sublicense and
provide TESARO with a copy of such sublicense, which may be redacted to remove
any sensitive information not necessary for TESARO to verify its compliance with
the terms of this Agreement.

2.4 No Implied Licenses, Negative Covenant.  Except as expressly set forth
herein, neither Party shall acquire any license or other right or interest, by
implication or otherwise, under any know-how, patents, trademarks, copyrights,
or any other intellectual property of the other Party.  ZAI covenants that it
will not, and it will not permit any of its Affiliates or sublicensees to, use
or practice any TESARO IP outside the scope of the license granted to it under
Section 2.1 above. 

2.5 Subcontracting.  Notwithstanding Section 2.3, ZAI shall have the right to
engage Subcontractors to perform Development and manufacturing activities
hereunder, without the prior written consent of TESARO, subject to the
provisions of this Section 2.5.  ZAI shall enter into an appropriate written
agreement with any subcontractor such that (i) such contractor shall be bound by
provisions that are consistent with all applicable provisions of this Agreement
to the same extent as ZAI, (ii) any such contractor to whom ZAI discloses
Confidential Information of TESARO shall enter into an appropriate written
agreement obligating such contractor to be bound by obligations of
confidentiality and restrictions on use of such TESARO Confidential Information
that are no less restrictive than the obligations in this Agreement, and
(iii) such contractor agrees to assign or license (with the right to grant
sublicenses) to ZAI any inventions related to the Licensed Compound or Licensed
Product(s) (and any Patent covering such inventions) made by such contractor in
performing such Development or manufacturing work for ZAI.  ZAI shall not use as
a Subcontractor any Third Party identified by TESARO to ZAI in writing, as a
prohibited Subcontractor, provided that if ZAI obtains TESARO’s written approval
to engage any particular Subcontractor(s), then TESARO shall not have the right
to subsequently designate such Subcontractor(s) as prohibited Subcontractor(s). 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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2.6 Right of First Negotiation.  On the condition that ZAI is in compliance with
the terms and conditions of this Agreement, TESARO hereby grants ZAI the right
of first negotiation to obtain a license to Develop and Commercialize in the
Field in the ZAI Territory any Follow-on Compound; provided, that TESARO is also
Developing such follow-on compound and TESARO has dosed the first patient in a
Phase 1 Clinical Trial with such Follow-on Compound.  With respect to each
Follow-on Compound, TESARO shall provide written notice to ZAI before filing any
IND for such compound, which notice shall include a reasonably detailed summary
of the pre-clinical data generated during the research and development of such
compound.  If ZAI notifies TESARO within thirty (30) days after the receipt of
such notice that it is interested in obtaining a license to develop and
commercialize such compound in the Field in the Territory, then TESARO shall
negotiate in good faith and exclusively with ZAI for a period of sixty (60) days
the terms and conditions of such license.  If the parties fail to reach
agreement on the terms and conditions of such a license within such ninety (90)
days, TESARO may enter into discussion with and grant such a license to any
Third Party and/or develop and commercialize such compound in the Field in the
Territory by itself.

2.7 PARP Inhibitor Exclusivity.    As partial consideration for TESARO granting
to ZAI the license set forth in Section 2.1, during the Term, ZAI shall not, and
shall cause its Affiliates to not, itself or in cooperation with or through
others, discover, research, develop, manufacture or commercialize any PARP
Inhibitor other than the Licensed Compounds and Licensed Product hereunder.  In
the event ZAI wishes to obtain the right (by licensing, merger or acquisition or
otherwise) to discover, research, develop, manufacture or commercialize any PARP
Inhibitor other than the Licensed Compounds and Licensed Products, ZAI shall
notify TESARO in writing, and TESARO may determine, in its sole discretion,
[***].

2.8 Co-Marketing Right. (a) Notwithstanding anything in this Agreement to the
contrary, TESARO shall have an exclusive right to co-promote each Licensed
Product in the Field in the ZAI Territory (the “Co-Promote Right”) on the terms
set forth in this Section 2.8. TESARO shall provide written notice to ZAI of its
intent to exercise the foregoing Co-Promote Right with respect to a Licensed
Product no later than twelve months prior to the First Commercial Sale of such
Licensed Product in the ZAI Territory (the “Co-Promote Notice”). The Co-Promote
Notice shall include TESARO’s written commitment to the following [***].

(b) For a period of ninety  (90) days following ZAI’s receipt of a Co-Promote
Notice, TESARO and ZAI will negotiate in good faith commercially reasonable
terms [***] upon which the parties would co-promote the applicable Licensed
Product in the ZAI Territory. If TESARO does not deliver a Co-Promote Notice for
a Licensed Product to ZAI within the applicable twelve-month period prior to
First Commercial Sale of such Licensed Product, then TESARO shall be deemed to
have waived its rights under this Section 2.8 solely with respect to the
applicable Licensed Product. If TESARO and ZAI do not mutually agree on the
terms upon which the parties would co-promote the applicable Licensed Product in
the ZAI Territory within the ninety (90) day negotiation period described above,
then the matter shall be referred to the Parties’ Executive Officers, who shall
meet promptly (either in person or via teleconference) and negotiate in good
faith in an attempt to come to an agreement.  If the Executive Officers cannot

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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come to an agreement within fifteen (15) days, then the final terms of the
co-promote shall be determined in accordance with the binding arbitration
procedure set forth in Section 14.2, except that the arbitrator’s decision will
be limited to selecting either the terms proposed by TESARO or the terms
proposed by ZAI, and such determination shall be final and binding on, and
non-appealable by, the Parties.

3. GOVERNANCE

3.1 Establishment of JSC.  The Parties will establish a joint steering committee
to review and oversee the Development and Commercialization of the Licensed
Compounds and Licensed Products and to coordinate the Parties’ activities under
this Agreement (the “Joint Steering Committee” or “JSC”).  Within thirty (30)
days after the Effective Date, each Party shall appoint two (2) representatives
to the JSC, each of which shall have sufficient seniority and relevant expertise
to make decisions within the scope of the JSC’s responsibilities.  The JSC may
change its size from time to time by mutual consent of the Parties; provided,
that the JSC will consist at all times of an equal number of representatives of
each of ZAI and TESARO.  Each Party may at any time replace its JSC
representatives upon written notice to the other Party.

3.2 Co-Chairpersons of JSC.  Each of ZAI and TESARO will select from their
representatives a co-chairperson for the JSC, and each Party may change its
designated co-chairperson from time to time upon written notice to the other
Party.  The co-chairpersons of the JSC will be responsible for calling meetings,
preparing and circulating an agenda and relevant materials (including drafts of,
updates to, or any proposed changes to a Development Plan) to the other Party at
least ten (10) business days in advance of each meeting, and preparing and
issuing minutes of each meeting within ten (10) business days thereafter.

3.3 JSC Responsibilities.  The JSC shall be responsible for: 

(a)        coordinating the activities of the Parties under this Agreement and
providing a forum for and facilitate communications between the Parties under
this Agreement;

(b)        reviewing, discussing and approving changes to the Development Plan,
overseeing the implementation of the Development Plan, and reviewing and
discussing the data and results of the Development activities under the
Development Plan, in each case, subject to the provisions of Section 3.5,
below, 

(c)        reviewing and discussing the Commercialization Plan and
Commercialization of the Licensed Products in the ZAI Territory;

(d)        reviewing, discussing and coordinating scientific presentations and
publication plans with respect to the Licensed Compound, Licensed Product and
any results arising therefrom during the course of the Development Plan in the
ZAI Territory, and

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(e)        performing such other functions as appropriate to further the
purposes of this Agreement, as expressly set forth in this Agreement or
allocated to it by the Parties in writing by mutual agreement.

3.4 JSC Meetings.  The JSC will hold meetings (either in-person or by
teleconference or videoconference) at such times and places as the
co-chairpersons may reasonably determine, provided that, unless the Parties
agree otherwise, the JSC will meet quarterly and only by teleconference,
videoconference or some other electronic means.  Each Party will bear its own
costs associated with attending meetings.  Each Party may from time to time
invite a reasonable number of participants, in addition to its representatives,
to attend the JSC meetings in a non-voting capacity.  Each individual attending
any JSC meeting hereunder (whether as a JSC member or invitee) shall be bound by
written non-use, non-disclosure terms and conditions at least as restrictive as
those set forth in this Agreement with respect to the Confidential Information
of the other Party (for clarity, this may be through employment agreements with
such individuals).

3.5 JSC Authority; Limitations.  Day-to-day operational level decisions
concerning the Development, manufacture and Commercialization of the Licensed
Compounds and Licensed Products in the ZAI Territory shall be made by
ZAI.  Material updates or changes to the Development Plan, including (for
clarity) any new clinical protocols or material changes to an approved clinical
protocol or material changes to strategy with respect to regulatory activities
in the ZAI Territory, shall require approval of the JSC.  The members of each
Party on the JSC shall collectively have one vote.  Except as otherwise provided
in this Section ‎3.5, decisions of the JSC shall be made by unanimous vote,
provided that at least one (1) representative from each Party participates in
such vote.  If the JSC does not reach unanimity with respect to a particular
matter, and the JSC is unable to resolve the dispute after endeavoring for
fifteen (15) business days to do so, then either Party may, by written notice to
the other, have such matter referred to the Parties’ Executive Officers, who
shall meet promptly (either in person or via teleconference) and negotiate in
good faith to resolve the dispute.  If the Executive Officers cannot resolve on
such dispute within fifteen (15) days, then ZAI shall have the final decision
making authority on such matter to the extent the matter that is the subject of
the dispute relates solely to the Development, manufacture or Commercialization
of the Licensed Compounds or the Licensed Products in the ZAI Territory and does
not impact the Development, manufacture or Commercialization of the Licensed
Compounds or the Licensed Products in the TESARO Territory.

3.6 Limitations on authority of JSC.  The JSC will have sole authority with
respect to the responsibilities assigned to such committees in Section 3.3 and
elsewhere in this Agreement.  The JSC shall not have any authority to amend,
modify or waive compliance with this Agreement.  For clarity, neither TESARO nor
ZAI will have any right to unilaterally modify, amend or waive its own
compliance with the terms of this Agreement.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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3.7 Alliance Managers.  Each Party shall appoint a single individual to act as
the primary point of contact between the Parties in connection with the
Development and Commercialization of the Licensed Compound and Licensed
Product(s) (the “Alliance Managers”).  Each Party may at any time appoint a
different Alliance Manager by written notice to the other Party and may elect,
upon mutual agreement by the Parties, to eliminate the responsibilities of the
Alliance Managers.  The Alliance Managers will (i) use good faith efforts to
attend all meetings of the JSC, any may also serve as voting members of the JSC,
and (ii) be the first point of referral for all matters of conflict resolution,
and bring disputes to the attention of the JSC in a timely manner.

4. TECHNOLOGY TRANSFER

4.1 Know-How.  Promptly after the Effective Date, TESARO shall, to the extent
not already delivered to ZAI, deliver to ZAI an electronic copy (either a CD-ROM
or access to a secured electronic database) of all material TESARO Know-How
relating the Licensed Compound or Licensed Products in the ZAI Territory
existing as of the Effective Date.  If any additional material TESARO Know-How
relating the Licensed Compound or Licensed Products in the ZAI Territory comes
into TESARO’s Control during the Term of this Agreement (including any Data
resulting from the Development of the Licensed Compounds and Licensed Products
in TESARO Territory), TESARO shall promptly notify ZAI and deliver an electronic
copy thereof to ZAI.  In addition, if at any time during the Term of this
Agreement, ZAI identifies particular documents, data or information that are
within the TESARO Know-How, but were not previously delivered to ZAI, including
without limitation materials requested in connection with an audit or other
inquiry by a Regulatory Authority relating to the Development, manufacture
and/or Commercialization of the Licensed Compounds and Licensed Products, TESARO
shall use reasonable efforts to promptly provide such material to ZAI upon
request.

4.2 Materials.  As soon as practicable after the Effective Date but in no event
later than the applicable deadline set forth in Exhibit C, TESARO shall provide
to ZAI[***] the quantities of Licensed Compounds, Licensed Products and other
materials as listed in Exhibit C to this Agreement.  Exhibit C shall also set
forth the cost to be paid by ZAI for the materials provided by TESARO.  In
connection with the supply of such Licensed Compounds, Licensed Products and
materials, TESARO shall also provide ZAI with relevant documents, including
batch records, certificate of analysis and certificate of compliance. All such
materials provided by TESARO hereunder shall not be used by ZAI for any purpose
other than Development, manufacture or Commercialization of the Licensed
Compound and Licensed Product(s) in the ZAI Territory in accordance with this
Agreement. 

4.3 Technical Assistance.  For a period of six (6) months after the Effective
Date, TESARO shall provide ZAI with reasonable technical assistance to help ZAI
to understand and use the TESARO Know-How to Develop and manufacture the
Licensed Compounds and Licensed Products.  Such technical assistance shall
include reasonable access, by teleconference or in-person at TESARO’s facilities
(subject to TESARO’s customary rules and restrictions with respect to site
visits by non-TESARO personnel), to TESARO personnel familiar with research,

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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development and manufacture of the Licensed Compounds and Licensed Products,
including CMC expertise in connection with the manufacture of the Licensed
Compounds and Licensed Products. 

4.4 Costs.  [***].   

5. DEVELOPMENT

5.1 General.  ZAI shall be solely responsible for the Development of the
Licensed Products in the Field throughout the Territory, at its own cost and
expense.  ZAI shall use Commercially Reasonable Efforts to Develop the Licensed
Products to obtain Regulatory Approval in the ZAI Territory, including but not
limited to, using Commercially Reasonable Efforts to carry out Development
(including regulatory activities as set forth in Section 5.5) of the Licensed
Products in accordance with the Development Plan and in compliance with
Applicable Law, including GCP. 

5.2 Development Plan.  The Development of the Licensed Product(s) in the ZAI
Territory shall be conducted by ZAI pursuant to a Development plan that will
include a description of the Development activities to be performed in support
of the Regulatory Approval of the Licensed Product(s) in the ZAI Territory,
including projected timelines for completion of such activities (the
“Development Plan”).  The initial Development Plan agreed to by the Parties is
attached hereto as Exhibit D.  Any material changes to the Development Plan
shall be drafted by ZAI and shared with TESARO, including the addition of any
clinical trial protocols or any material changes thereto, and shall require the
approval of TESARO (such approval not to be unreasonably withheld).  In the
event of any proposed change to the Development Plan as a result of any
interaction with any Regulatory Authority, the JSC shall meet as promptly as
practicable to review and discuss any such proposed changes and determine an
appropriate revision (if any) to the Development Plan.

5.3 Development Records and Reporting.

(a)        Records.  ZAI shall maintain complete and accurate records of all
work conducted by or on behalf of ZAI in furtherance of the Development of
Licensed Product(s) and all material results, Data and developments made in
conducting such activities.  Such records shall be maintained in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes and in accordance with Applicable Law.  

(b)        Reporting.  ZAI will provide to TESARO, a written report at least
once each calendar quarter, in English, describing in reasonable detail ZAI’s
activities and progress related to the Development of the Licensed Products in
the ZAI Territory pursuant to the Development Plan.  ZAI shall promptly respond
to TESARO’s reasonable questions or requests for additional information relating
to such Development activities.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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5.4 Data Sharing and Use. 

(a)        Data Sharing.  In addition to the adverse event and safety report
reporting obligations under Section 5.7 below, each Party shall promptly provide
the other Party with copies of all material Data and results generated from its
(including its Affiliates’, licensees’ and sublicensees’) Development of the
Licensed Compounds and Licensed Products in its Territory to the extent
necessary for the Development of the Licensed Compounds and Licensed Products in
the other Party’s Territory. 

(b)        Use by ZAI.  ZAI shall have the right to use and reference any
material Data (including related Regulatory Materials) generated from the
Development of the Licensed Compounds and Licensed Products in the TESARO
Territory (which shall be automatically included in TESARO IP) in support of
obtaining Regulatory Approvals for the Licensed Product(s) in the ZAI
Territory.  ZAI may use and reference all such material Data to Develop,
manufacture and Commercialize the Licensed Compounds and Licensed Products in
the ZAI Territory, without additional payment or compensation to TESARO.

(c)        Use by TESARO.  ZAI shall, as part of the license to TESARO under ZAI
Inventions pursuant to Section 10.1(b), provide the right for TESARO to use and
reference the material Data generated from the Development of the Licensed
Compounds and Licensed Products in the ZAI Territory in support of obtaining
Regulatory Approvals for the Licensed Product(s) in the TESARO Territory.

5.5 Regulatory Activities.  ZAI shall apply for (and maintain), at ZAI’s cost
and expense, all Regulatory Approvals of Licensed Products in the ZAI
Territory.  ZAI shall be responsible for the preparation of all Regulatory
Materials and all communications and interactions with Regulatory Authorities
with respect to the Licensed Products in the ZAI Territory, both prior to and
subsequent to Regulatory Approval.  ZAI shall file all required regulatory
dossiers to obtain (and maintain) Regulatory Approvals of the Licensed Products
in the ZAI Territory, and will be the holder of such Regulatory Approvals. 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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5.6 Regulatory Materials and Meetings.  ZAI shall promptly provide TESARO with
an electronic copy of all Regulatory Materials and correspondence with
Regulatory Authorities by ZAI with respect to the Development of the Licensed
Products in the ZAI Territory.  During the time period that ZAI is conducting
the Development Plan, to the extent legally permissible and practicable, ZAI
shall provide TESARO prior notice with respect to all meetings, conferences and
discussions with Regulatory Authorities (including advisory committee meetings
and any other meeting of experts convened by a Regulatory Authority) regarding
the Licensed Product(s),  provided however, ZAI is not obligated to provide
TESARO prior notice for meetings, conferences or discussions with Regulatory
Authorities that are informal or not previously scheduled.  ZAI shall provide
such notice within five (5) Business Days after ZAI receives notice of the
scheduling of such meeting, conference, or discussion.  TESARO shall be entitled
to be present at (but not to participate in, unless requested by ZAI or the
Regulatory Authority) all such meetings, conferences or discussions with
Regulatory Authorities to the extent permitted under Applicable Laws, provided,
however, in the event that, in ZAI’s reasonable judgment, TESARO’s presence in
any such meeting, conference or discussion will negatively affect the outcome of
such meeting, conference or discussion, TESARO shall defer to ZAI’s reasonable
judgment.

5.7 Pharmacovigilance.  Within ninety (90) days after the Effective Date, the
Parties shall define and finalize the actions that the Parties shall employ with
respect to the Licensed Compounds and Licensed Products to protect patients and
promote their well-being in a written pharmacovigilance agreement (the
“Pharmacovigilance Agreement”).  These responsibilities shall include mutually
acceptable guidelines and procedures for the receipt, investigation,
recordation, communication, and exchange (as between the Parties) of adverse
event reports, pregnancy reports, and any other information concerning the
safety of any Licensed Product.  Such guidelines and procedures shall be in
accordance with, and enable the Parties to fulfill, local and national
regulatory reporting obligations under Applicable Laws.  Furthermore, such
agreed procedure shall be consistent with relevant ICH guidelines, except where
said guidelines may conflict with existing local regulatory reporting safety
reporting requirements, in which case local reporting requirement shall
prevail.  Each Party shall be responsible for reporting quality complaints,
adverse events and safety data related to a Licensed Product to applicable
Regulatory Authorities in its Territory, as well as responding to safety issues
and to all requests of Regulatory Authorities relating to a Licensed Product in
its Territory.  The Pharmacovigilance Agreement shall also provide for a
worldwide safety database to be maintained by TESARO at its cost.  Each Party
hereby agrees to comply with its respective obligations under such
Pharmacovigilance Agreement and to cause its Affiliates and permitted
sublicensees to comply with such obligations.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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5.8 Remedial Actions.  Each Party will notify the other Parties immediately, and
promptly confirm such notice in writing, if it obtains information indicating
that any Licensed Product may be subject to any recall, corrective action or
other regulatory action with respect to such product taken by virtue of
Applicable Law (a “Remedial Action”).  The Parties will assist each other in
gathering and evaluating such information as is necessary to determine the
necessity of conducting a Remedial Action.  Each Party shall, and shall ensure
that its Affiliates and sublicensees will, maintain adequate records to permit
the Parties to trace the manufacture, distribution and use (to the extent
possible) of the Licensed Products.  As between the Parties, ZAI shall have sole
discretion with respect to any matters relating to any Remedial Action for the
Licensed Product in the ZAI Territory and TESARO shall have sole discretion with
respect to any matters relating to any Remedial Action for the Licensed Product
in the TESARO Territory.  In the event that a Party determines that any Remedial
Action with respect to the Licensed Product in its Territory should be
commenced, or if Remedial Action is required by any Regulatory Authority having
jurisdiction over the matter in its Territory, such Party will control and
coordinate all efforts necessary to conduct such Remedial Action and shall be
responsible for all cost and expense of such Remedial Action in its
territory.   

6. COMMERCIALIZATION

6.1 General.  ZAI shall have the sole right to and responsibility for the
Commercialization of Licensed Products in the ZAI Territory, including
manufacturing, selling, distributing and invoicing Licensed Products and would
book one hundred percent (100%) of the sales, in the ZAI Territory.  ZAI shall
use Commercially Reasonable Efforts to Commercialize the Licensed Products in
the ZAI Territory after Regulatory Approval has been obtained, and shall conduct
its Commercialization activities with respect to the Licensed Products in
accordance with Applicable Law.

6.2 Coordination of Commercialization Activities. 

(a)        General.  The Parties recognize that they may benefit from the
coordination of certain activities in support of the Commercialization of the
Licensed Products in the ZAI Territory. As such, the Parties will coordinate
such activities where appropriate and as such coordination may be mutually
agreed by the Parties.  ZAI shall update TESARO in writing on a quarterly basis,
through the JSC, of the expected timing of the commercial launch and First
Commercial Sale of each Licensed Product in the ZAI Territory. 

(b)        Pricing.  Each Party shall have the right to determine the price of
the Licensed Product sold in its Territory and no Party shall have the right to
direct, control or approve the pricing of the Licensed Product in the other
Party’s Territory. 

(c)        Global Brand Elements.  The Parties, through their respective
Alliance Managers, may endeavor to develop and adopt the key distinctive colors,
logos, images, symbols, and trademarks to be used in both Territories in
connection with the Commercialization of the Licensed Products.  Each Party
shall own the rights in such global brand elements in its

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Territory and shall Commercialize the Licensed Products in its Territory in a
manner consistent with the applicable global brand elements. 

(d)        Market Research and Materials.  At each regularly scheduled JSC
meeting, each Party shall update the other Party regarding the material market
research that it is performing with respect to the Licensed Products, and shall
provide the other Party with a copy of such research upon request if such
material market research is necessary for the other Party to commercialize the
Licensed Products in its Territory.  The Parties shall also share copies of all
marketing and promotional materials with respect to the Commercialization of the
Licensed Products with each other.

6.3 Diversion.  Each Party hereby covenants and agrees that it and its
Affiliates shall not, and it shall contractually obligate (and use Commercially
Reasonable Efforts to enforce such contractual obligation) its licensees and
sublicensees not to, directly or indirectly, actively promote, market,
distribute, import, sell or have sold any Licensed Product, including via the
Internet or mail order, to any Third Party or to any address or Internet
Protocol address or the like in the other Party’s Territory.  Neither Party
shall engage, nor permit its Affiliates and sublicensees to engage, in any
advertising or promotional activities relating to any Licensed Product for use
directed primarily to customers or other buyers or users of such product located
in any country or jurisdiction in the other Party’s Territory, or solicit orders
from any prospective purchaser located in any country or jurisdiction in the
other Party’s Territory.  If a Party or its Affiliates or sublicensees receives
any order for a Licensed Product for use from a prospective purchaser located in
a country or jurisdiction in the other Party’s Territory, such Party shall
immediately refer that order to such other Party and shall not accept any such
orders.  Neither Party shall deliver or tender (or cause to be delivered or
tendered), nor permit its Affiliates and sublicensees to, deliver or tender (or
cause to be delivered or tendered) any Licensed Product for use in the other
Party’s Territory. 

6.4 Trademark.  Subject to Section 6.2(c), ZAI shall have the right to brand the
Licensed Products in the ZAI Territory using ZAI related trademarks and any
other trademarks and trade names it determines appropriate for the Licensed
Products, which may vary by country or within a country.  ZAI shall own all
rights in such trademarks and register and maintain such trademarks in the
countries and regions within the ZAI territory, where it determines
appropriate. 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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7. MANUFACTURE AND SUPPLY

7.1 Product Manufacture and Supply.  Except for the initial supply set forth in
Section 4.2 above, ZAI shall be solely responsible for, either by itself or
through its Affiliates or Third Party contact manufactures, the manufacture and
supply of all necessary clinical and commercial supply of the Licensed Compounds
and Licensed Products, in conformance with the applicable specifications thereof
and all Applicable Laws, for both Development and Commercialization of the
Licensed Compounds and Licensed Products in the ZAI Territory.  To the extent
necessary for the Development of the Licensed Compounds and Licensed Products in
the ZAI Territory in accordance with this Agreement, ZAI shall obtain all other
clinical supplies, and acknowledges and agrees that (a) such clinical supplies
shall be manufactured and supplied in accordance with the Good Manufacturing
Practice for Drugs (药品生产质量管理规范) promulgated by CFDA, and (b) ZAI shall be
responsible for labeling of such supplies and distribution to clinical
sites.  Notwithstanding the foregoing, ZAI shall not use any contract
manufacturer or materials supplier listed on Schedule 7.1, for the purposes of
manufacturing Licensed Compounds or Licensed Products, without the prior written
consent of TESARO.

7.2 Manufacturing Technology Transfer.  Without limiting Article 4, upon ZAI’s
reasonable request, TESARO shall transfer to ZAI or its designated Third Party
contract manufacturer all material TESARO Know-How necessary to manufacture the
Licensed Compound and Licensed Product.  In connection with such technology
transfer, TESARO shall provide reasonable technical assistance, at ZAI’s cost,
to enable ZAI or its designated Third Party contract manufacturer to manufacture
the Licensed Compound and Licensed Product.

7.3 Supply by TESARO.  At any time during the Term, upon ZAI’s written request,
TESARO and ZAI may negotiate in good faith terms and conditions of a separate
supply agreement, pursuant to which TESARO would manufacture and supply Licensed
Compound and/or Licensed Product to ZAI; provided, neither party is obligated to
enter into any such supply agreement. Notwithstanding the foregoing, in the
event ZAI is required by the CFDA to Commercialize the Licensed Product as an
imported product, and the Parties have not entered into the supply agreement
referred to above, then (a) TESARO will use Commercially Reasonable Efforts to
manufacture and supply the Licensed Compound and/or Licensed Product to ZAI for
such Commercialization purposes pursuant to the terms of a supply agreement to
be negotiated in good faith between the parties, which terms shall include
[***].

8. FINANCIAL TERMS    

8.1 License Fee Consideration. 

(a)        Upfront Payment.  As partial consideration to TESARO for the rights
and licenses granted to ZAI hereunder, ZAI shall pay to TESARO fifteen million
Dollars ($15,000,000) non-refundable, non-creditable upfront payment, due thirty
(30) business days after the Effective Date.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(b)        Right of First Refusal.  As partial consideration to TESARO for the
rights and licenses granted to ZAI hereunder, ZAI hereby grants TESARO the right
to enter into a license described in this Section 8.1(b) with respect to each of
the first two Immuno-oncology assets [***] (each, an “Immuno-Oncology Asset”)
developed by ZAI during the Term. If, at any time during the Term, ZAI develops
and intends to advance any such Immuno-Oncology Asset into human clinical trials
in the ZAI Territory, then at least six months prior to the initiation of any
human clinical trial of such Immuno-Oncology Asset in the ZAI Territory, ZAI
will notify TESARO in writing of such intent and provide TESARO with a
confidential written summary of the Immuno-Oncology Asset, including all
material clinical, pre-clinical and other relevant data that TESARO may
reasonably request which would be necessary for TESARO to determine whether to
exercise its right to license such Immuno-Oncology Asset under this Section
8.1(b) (a “Transaction Notice”), which Transaction Notice shall be deemed to be
Confidential Information of ZAI under this Agreement. TESARO will notify ZAI
within [***] of its receipt of the Transaction Notice whether TESARO would like
to exercise its right under this Section 8.1(b) to obtain an exclusive,
worldwide (excluding China), sub-licensable, royalty-bearing license to
research, develop, manufacture and commercialize the applicable Immuno-Oncology
Asset for all uses (an “Option Notice”). For a period of [***] following ZAI’s
receipt of an Option Notice, TESARO and ZAI will negotiate in good faith
commercially reasonable terms for the foregoing license of the applicable
Immuno-Oncology Asset to TESARO. If TESARO does not deliver an Option Notice to
ZAI within the applicable [***] period, or declines in writing its option to
take a license to the applicable Immuno-Oncology Asset after review of the
Transaction Notice, then TESARO shall be deemed to have waived its rights under
this Section 8.1(b) solely with respect to the applicable Immuno-Oncology Asset,
and ZAI will be free to enter into a license for such Immuno-Oncology Asset with
any Third Party thereafter.  If TESARO exercises its option by providing the
Option Notice with respect to the applicable Immuno-Oncology Asset, but TESARO
and ZAI do not mutually agree on the terms of a license to TESARO within the
[***] negotiation period described above, ZAI may not enter into any license
transaction for such Immuno-Oncology Asset outside of the ZAI Territory with any
Third Party for a period of [***] following the end of such [***] negotiation
period (the “Restricted Period”). After the end of the Restricted Period, ZAI is
permitted to negotiate a license for the applicable Immuno-Oncology Asset with a
Third Party; provided,  however, that ZAI may not enter into a license for the
applicable Immuno-Oncology Asset with a Third Party on financial terms that are
materially less favorable, in the aggregate, to ZAI than those offered by TESARO
(collectively, the “Third Party Terms”).  [***]  For the sake of clarity,
nothing in this Section 8.1(b) shall be deemed to restrict ZAI’s ability to
grant of a license to a service provider or to a Third Party distributor selling
finished Immuno-Oncology Product purchased from ZAI. 

8.2 Milestone Payments. 

(a)        Development Milestone. ZAI shall pay to TESARO the following one-time
milestone payments within [***] following the first achievement of the
corresponding milestone events set forth below by ZAI, its Affiliates or
sublicensees for any Licensed Compound or Licensed Product.  For purposes of
clarity, the milestone payment set forth below shall be payable only upon the
first achievement of such milestone, and shall not be payable more than

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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once, regardless of whether more than one Licensed Compound or Licensed Product
achieves such milestone.

 

 

 

Development Milestone Event

Milestone Payment

[***]

$[***]

Notwithstanding the foregoing, if ZAI’s Development activities cause TESARO to
owe Merck a milestone payment under the “Development Milestone” section of
Section 7.02 of the Merck Agreement and TESARO has not received from ZAI a
corresponding milestone payment under this Section 8.2(a), then ZAI shall pay to
TESARO, in accordance with the terms of this Agreement the amount of the
milestone payment owed by TESARO to Merck.

(b)        Sales-Based Milestones.  ZAI shall pay to TESARO the following one
time milestone payments upon reaching the following specific Net Sales
milestones for the Licensed Product(s) within [***] following the end of the
Calendar Year during which the Net Sales milestone set forth below is first
reached: 

 

 

 

Annual Net Sale of all Licensed Products in the Territory

Milestone Payments

Equal or exceed                                         $[***]

$[***]

Equal or exceed                                         $[***]

$[***]

Equal or exceed                                          $[***]

$[***]

8.3 Royalties. 

(a)        Generally.  Subject to the remainder of this Section 8.3, ZAI shall
pay to TESARO a running royalty on Net Sales of each Licensed Product sold by
ZAI, its Affiliates and Sublicensees in the Field in the ZAI Territory, as
calculated by multiplying the applicable royalty rate set forth below by the
corresponding amount of incremental, aggregated annual Net Sales of the Licensed
Product sold in the Territory in the applicable Calendar Year:

 

 

Portion of Annual Net Sales of the Licensed Product in the Territory

Royalty Rate

Less than or equal to                                       $[***]

[***]%

Greater than                                                    $[***]
but less than or equal to                                  $[***]

[***]%

Greater than                                                    $[***]

[***]%

(b)        Royalty Term.  Subject to subsection (d) below, royalties shall be
payable on a country-by-country and Licensed Product-by-Licensed Product basis
from the First Commercial Sale of a Licensed Product in a country until the last
to occur of: (i) expiration of the last to expire TESARO Patents that contains a
Valid Claim Covering such Licensed Product in

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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such country or administrative region; (ii) expiration of any market or data
exclusivity for the sale of such Licensed Product in such country or
administrative region; or (iii) ten (10) years from the First Commercial Sale of
such Licensed Product in such country or administrative region (the “Royalty
Term”). 

(a)        Royalty Reductions. 

(i) If a Licensed Product is generating Net Sales in a country or administrative
region during the Royalty Term in such country at a time when there is no TESARO
Patent that contains a Valid Claim Covering the composition of matter of such
Licensed Product in such country or administrative region, then the royalty rate
for such Licensed Product in such country or administrative region shall be
reduced by [***].

(ii) If it is necessary for ZAI to obtain a license from a Third Party under any
Patents in order to manufacture, import or sell the Licensed Product in a
country or administrative region in the ZAI Territory and ZAI obtains such a
license, then ZAI shall have the right to deduct, from the royalty payment that
would otherwise have been due pursuant to this Section 8.3 with respect to Net
Sales of such Licensed Product in such country or administrative region, an
amount equal to [***] of the amount paid by ZAI to such Third Party pursuant to
such patent license on account of the sale of such Licensed Product in such
country during such Calendar Quarter; provided however, that in no event shall
the royalties paid to TESARO with respect to such Net Sales by operation of this
Section 8.3(c)(ii) be reduced to less than [***] of the amount that would
otherwise due with respect to such Net Sales. 

(b)        Minimum Royalties.  Notwithstanding the foregoing, the royalties due
from ZAI to TESARO under this Agreement with respect to the Net Sales of the
Licensed Product in the Territory in a particular Calendar Quarter shall be no
less than the royalties owed by TESARO to Upstream Licensors under the Upstream
Agreements with respect to such Net Sales plus [***] of such Net Sales. 

(c)        Upstream Royalties.  TESARO shall be solely responsible for the
payment of royalties and other payments owed by TESARO to Upstream Licensors and
any other Third Parties on account of the Development and Commercialization of
the Licensed Product by ZAI in the Territory. 

(d)        Royalty Conditions.  The royalties under Section 8.3 shall be subject
to the following conditions:

(iii) only one (1) royalty shall be due with respect to each unit of Licensed
Product, without regard to whether there is more than one Valid Claim Covering
such Licensed Product;

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(iv) no royalties shall be due upon the sale or other transfer of the Licensed
Products among ZAI, its Affiliates and sublicensees, but in such cases the
royalty shall be due and calculated upon ZAI’s or its Affiliate’s or
sublicensee’s Net Sales of Licensed Product to the first independent Third
Party; and

(v) no royalties shall accrue on the disposition of Licensed Product in
reasonable quantities by ZAI, its Affiliates or sublicensees as part of an
expanded access program, for use in clinical trials, as free samples, or as
donations to non-profit institutions or government agencies for non-commercial
purposes, provided, in each case, that neither ZAI, its Affiliate nor
sublicensees receive any payment (in excess of its actual costs) for such
Licensed Product.

8.4 Manner of Payment.  All payments to be made by ZAI hereunder shall be made
in U.S. Dollars by wire transfer of immediately available funds to such bank
account as shall be designated by TESARO.  Except as otherwise provided in this
Agreement, all payments to be made by ZAI under this Agreement shall be due
within [***] of the date of invoice.  Late payments shall bear interest at the
rate provided in Section 8.10.

8.5 Sales Reports and Royalty Payments.  Any royalty payments due under this
Agreement will be calculated and reported for each Calendar Quarter, and will be
paid within [***] of the end of each Calendar Quarter in which the applicable
Net Sales were recorded.    Each royalty payment will be accompanied by a report
stating on a Licensed Product-by-Licensed Product: (a) Net Sales of the Licensed
Product in the applicable Calendar Quarter, (b) a calculation of the amount of
the royalty payment due on such Net Sales during the applicable Calendar
Quarter, and (c) the amount of withholding taxes, if any, required by Applicable
Law to be deducted with respect to such royalties.

8.6 Financial Records.  ZAI will maintain records as are required to determine,
in accordance with this Agreement, Net Sales and royalties due under this
Agreement.  ZAI will maintain such records until the later of (a) three (3)
years after the end of the period to which such records pertain, (b) the
expiration of the applicable tax statute of limitations (or any extensions
thereof), or (c) such longer period as may be required by Applicable Law.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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8.7 Financial Audit.  On thirty (30) days prior written notice, TESARO will have
the right to have an independent certified public accountant inspect the
financial records of ZAI and its Affiliates and their Sublicensees relating to
the sale of the Licensed Products in the ZAI Territory, no more than once per
Calendar Year, during usual business hours, at a time and a place mutually
agreed to, for the sole purpose of verifying the completeness and accuracy of
Net Sales and royalties due under this Agreement for the period of time three
(3) years preceding the date of the notice.  The notice must identify the period
of time subject to inspection.  Records from a period of time already subject to
an inspection pursuant to this Section 8.7 may not be inspected again.  Such
accountant must have agreed in writing to maintain the confidentiality of all
information learned in confidence, except as necessary to disclose any
discrepancy to TESARO.  TESARO shall pay for such inspections, unless such
inspection and audit discloses for the period examined that there is an
underpayment to TESARO of greater than [***] of the amounts actually due in any
given year, in which case ZAI will be responsible for the payment of the
reasonable cost of such inspection and audit.  TESARO and its independent
accounting firm agree that all information concerning such payments and reports
will be Confidential Information of ZAI as provided for in this Agreement.  ZAI
will pay to TESARO within sixty (60) days any underpayment identified pursuant
to this Section ‎8.7.

8.8 Currency Exchange.  With respect to Net Sales invoiced in a currency other
than Dollars, the Net Sales shall be expressed in the domestic currency of the
entity making the sale, together with the Dollar equivalent (as applicable),
calculated using the rate of exchange to be used in computing the amount of
currency equivalent in Dollars by ZAI for its own financial reporting purposes
in connection with its other products.

8.9 Taxes.  (a) In the event that Applicable Law requires ZAI to deduct or
withhold taxes with respect to any payment to be made by ZAI pursuant to this
Agreement, ZAI will notify TESARO of such requirement prior to making the
payment to TESARO and provide such assistance to TESARO, including the provision
of such documentation as may be required by a tax authority, as may be
reasonably necessary in TESARO’s efforts to claim an exemption from or reduction
of such taxes. ZAI will, in accordance with Applicable Law, deduct or withhold
taxes from the amount due, remit such taxes to the appropriate tax authority
when due, and furnish TESARO with proof of payment of such taxes within thirty
(30) days following the payment. If taxes are paid to a tax authority, ZAI shall
provide reasonable assistance to TESARO to obtain a refund of taxes withheld, or
obtain a credit with respect to taxes paid.  To the extent such amounts are paid
to the appropriate tax authority, such amounts shall be treated for all purposes
of this Agreement as having been paid to TESARO.

(b) All payments due to TESARO from ZAI pursuant to this Agreement shall be paid
net of any value-added tax or other tax (“VAT”) required to be paid by ZAI to
tax authorities in the Territory (which, if applicable, shall be payable by ZAI
upon receipt of a valid VAT invoice); provided, that ZAI shall use commercially
reasonable efforts to assist TESARO to minimize and obtain all available
exemptions from such VAT or other taxes. If ZAI is required to withhold and/or
TESARO is required to report any such tax, ZAI shall promptly provide TESARO
with

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

 

 

applicable receipts evidencing payment of such tax and other documentation
reasonably requested by TESARO.

8.10 Interest on Late Payment.  Interest shall be payable on any payments that
are not paid on or before the date thirty (30) days after the date such payments
are due under this Agreement at the per-annum rate of prime (as reported in The
Wall Street Journal (U.S., Eastern Edition)) plus two percentage points or the
maximum rate allowable by applicable Law, whichever is less.

9. REPRESENTATIONS AND WARRANTIES; COVENANTS

9.1 Mutual Representations and Warranties.  Each Party represents and warrants
to the other Party that:

(a)        It is duly organized, validly existing and in good standing under the
laws of the jurisdiction in which it is incorporated;

(b)        It has all requisite corporate power and authority to enter into this
Agreement and to perform its obligations under this Agreement;

(c)        The execution of this Agreement and the performance by such Party of
its obligations hereunder have been duly authorized;

(d)        This Agreement is legally binding and enforceable on such Party in
accordance with its terms; and

(e)        The performance of this Agreement by it does not create a material
breach or material default under any other agreement to which it is a Party.

9.2 Representations and Warranties of TESARO.  TESARO represents and warrants
that as of the Effective Date:

(a)        TESARO is the sole owner or exclusive licensee of the TESARO IP, free
and clear of all liens, and has the right to grant to ZAI the rights and
licenses as purported to be granted hereunder;  

(b)        there is no pending or, to its knowledge, threatened, litigation or
arbitration which alleges, or any written communication alleging, that TESARO’s
activities with respect to the TESARO IP or the Licensed Compounds have
infringed or misappropriated any of the intellectual property rights of any
Third Party; 

(c)        there is no pending or, to its knowledge, threatened re-examination,
opposition, interference or litigation, or any written communication alleging
that any TESARO Patent is invalid or unenforceable anywhere in the world;

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(d)        subject to the terms and conditions of the Upstream Agreements, to
its knowledge, the manufacture, Development or Commercialization of the Licensed
Compounds and Licensed Products does not and will not infringe with any
Patent  rights of any Third Party in the ZAI Territory;

(e)        it is not aware of any infringement or misappropriation of any TESARO
IP by any Third Party;

(f)        it (and, to its knowledge, any Third Party acting under its
authority) has complied in all material respects with all Applicable Laws in
connection with its development of the Licensed Compounds (including information
and data provided to Regulatory Authorities), and has not used any employee,
consultant or contractor who has been debarred by any Regulatory Authority, or
to its knowledge, is the subject of a debarment proceeding by any Regulatory
Authority;

(g)        it has not granted any rights in the TESARO IP that are inconsistent
with the rights granted to ZAI under this Agreement;

(h)        other than the Patents set forth in Exhibit B, TESARO does not
Control any Patent that is reasonably necessary for the Development, manufacture
or Commercialization of the Licensed Compound or Licensed Product or that Covers
(i) the composition of matter of the Licensed Compound or Licensed Product, or
(ii) a method of manufacture or use of the Licensed Compound or Licensed
Product.  If TESARO identifies any Patent that it Controls after the Effective
Date which is reasonably necessary for the Development, manufacture or
Commercialization of the Licensed Compound or Licensed Product in the ZAI
Territory or that Covers (A) the composition of matter of the Licensed Compound
or Licensed Product, or (B) a method of manufacture or use of the Licensed
Compound or Licensed Product, then such Patent shall automatically be added to
the list of TESARO Patents;  

(i)        the Licensed Compounds and Licensed Products provided by TESARO as
part of the technology transfer under Section 4.2 have been manufactured,
handled and stored in accordance with all Applicable Laws, including the current
Good Manufacturing Practice set forth in 21 C.F.R. Parts 11, 210 and 211; and

(j)        TESARO has disclosed to ZAI and made available to ZAI for review, to
the extent in TESARO’s possession and control, all material non-clinical and
clinical data for the Licensed Compound and Licensed Product, and all other
material information (including relevant correspondence with Regulatory
Authorities) relating to the Licensed Compound and Licensed Product, in each
case that would be material to TESARO to assess the safety and efficacy of the
Licensed Compound and Licensed Product.

9.3 Upstream Agreements.  TESARO represents, warrants and covenants (as
applicable) to ZAI that:

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(a)        as of the Effective Date, except for the Upstream Agreements, there
is no agreement between TESARO or its Affiliates with any Third Party pursuant
to which TESARO or its Affiliates has in-licensed any TESARO IP;

(b)        as of the Effective Date, it has provided ZAI with a true and
complete copy of each Upstream Agreement, and each Upstream Agreement is in full
force and effect, and the (sub)licenses it obtained under the AZ Agreements
encompass the right to make, use and sell the Licensed Compound and Licensed
Product in the Field in the ZAI Territory in accordance with the terms of the AZ
Agreements, and during the Term, TESARO shall not modify or terminate either of
the AZ Agreements in a manner that would diminish the right of ZAI under this
Agreement to make, use and sell the Licensed Compound and Licensed Product in
the Field in the ZAI Territory;

(c)        as of the Effective Date, no written notice of default or termination
has been received or given under any Upstream Agreement, and to its knowledge,
there is no act or omission by TESARO that would provide a right to terminate
any Upstream Agreement;

(d)        during the Term of this Agreement, it shall maintain each Upstream
Agreement in full force and effect and shall not terminate, amend, waive or
otherwise modify (or consent to any of the foregoing) its rights under any
Upstream Agreement in any manner that materially diminishes the rights or
licenses granted to ZAI hereunder or increase or generate any new payment
obligation under any Upstream Agreement that would apply to ZAI (such as any
milestone payment under Section 7.02 of the Merck Agreement that would apply to
ZAI’s Development activities), without ZAI’s express written consent; and

(e)        in the event of any notice of breach of any Upstream Agreement by
TESARO, TESARO shall promptly notify ZAI in writing, and if TESARO fails to cure
such breach, ZAI shall have the right, but not the obligation, to cure such
breach on behalf of TESARO and to offset any reasonable amounts incurred or paid
by ZAI in connection with the cure of such breach against any amounts otherwise
payable by to TESARO under this Agreement.  In the event of any notice of breach
of any Upstream Agreement by the applicable Upstream Licensor in a manner that
will or is likely to materially adversely affect ZAI’s rights or obligations
under this Agreement, TESARO shall immediately notify ZAI in writing, and TESARO
shall take such actions as reasonably requested by ZAI to enforce such Upstream
Agreement. 

9.4 ZAI Compliance with Upstream Agreements.  ZAI acknowledges and agrees that
the rights and licenses granted by TESARO to ZAI under this Agreement are
subject to the terms of the Upstream Agreements.  ZAI agrees to take any action
(or omission, to the extent applicable to ZAI) reasonably requested by TESARO
that is necessary or advisable to maintain compliance with the terms and
conditions of the Upstream Agreements.

9.5 Anti-Corruption. 

(a)        In performing their respective obligations hereunder, the Parties
acknowledge that the corporate policies of TESARO and ZAI and their respective
Affiliates

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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require that each Party’s business be conducted within the letter and spirit of
the law.  By signing this Agreement, each Party agrees to conduct the business
contemplated herein in a manner which is consistent with all Applicable Law,
including the U.S. Foreign Corrupt Practices Act, good business ethics, and its
ethics and other corporate policies, and to abide by the spirit of the other
Party’s applicable ethics and compliance guidelines which may be provided by
such other Party from time to time.  Specifically, each Party agrees that it has
not, and covenants that it, its Affiliates, and its and its Affiliates’
directors, employees, officers, and anyone acting on its behalf, will not, in
connection with the performance of this Agreement, directly or indirectly, make,
promise, authorize, ratify or offer to make, or take any action in furtherance
of, any payment or transfer of anything of value for the purpose or intent of
influencing, inducing or rewarding any act, omission or decision to secure an
improper advantage; or improperly assisting it in obtaining or retaining
business for it or the other Party, or in any way with the purpose or effect of
public or commercial bribery.

(b)        Each Party shall not contact, or otherwise knowingly meet with, any
Government Official for the purpose of discussing activities arising out of or
in connection with this Agreement, without the prior written approval of the
other Party, except where such meeting is consistent with the purpose and terms
of this Agreement and in compliance with Applicable Law, it being agreed and
acknowledged that ZAI has the right under this Agreement to meet with any
Government Official with respect to the lawful conduct of any clinical study for
the Licensed Product.

9.6 Disclaimer.  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY
MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO ANY PATENTS, CONFIDENTIAL INFORMATION OR
KNOW-HOW OF SUCH PARTY OR ANY LICENSE GRANTED BY SUCH PARTY HEREUNDER, OR WITH
RESPECT TO ANY COMPOUNDS, INCLUDING BUT NOT LIMITED TO THE TRANSFERRED
MATERIALS.  FURTHERMORE, EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES THAT ANY PATENT, PATENT
APPLICATION, OR OTHER PROPRIETARY RIGHTS INCLUDED IN PATENTS, CONFIDENTIAL
INFORMATION OR KNOW-HOW LICENSED BY SUCH PARTY TO THE OTHER PARTY HEREUNDER ARE
VALID OR ENFORCEABLE OR THAT USE OF SUCH PATENTS, CONFIDENTIAL INFORMATION OR
KNOW-HOW CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENTS OR OTHER
INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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9.7 Limitation of Liability.  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR
OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT,
SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES PROVIDED,
HOWEVER, THAT THE FOREGOING SHALL NOT APPLY TO OR LIMIT (I) DAMAGES AVAILABLE
FOR ANY BREACH BY EITHER PARTY OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN
ARTICLE ‎11; (B) A PARTY’S INDEMNIFICATION OBLIGATIONS SET FORTH IN ARTICLE 12.
 

10. INTELLECTUAL PROPERTY

10.1 Inventions.

(a)        Ownership of Inventions.  The inventorship of all Inventions shall be
determined under the U.S. patent laws.  Each Party shall solely own its Sole
Inventions and the Parties shall jointly own all Joint Inventions.  All Patents
Covering patentable Joint Inventions shall be referred to herein as “Joint
Patents.”  Except to the extent restricted by the licenses granted to other
Party under this Agreement or any other agreement between the Parties, each
joint owner shall be entitled to practice, license, assign and otherwise exploit
the Joint Inventions and Joint Patents without the duty of accounting or seeking
consent from the other owners

(b)        License of Inventions.  TESARO’s Sole Inventions and TESARO’s right
and interest in and to any Joint Inventions shall be included in TESARO IP and
automatically licensed to ZAI under this Agreement.  Further, ZAI hereby grants
to TESARO an exclusive, perpetual and freely sublicensable license under ZAI’s
Sole Inventions and ZAI’s right and interest in and to any Joint Inventions,
including the Data generated by ZAI from the Development of the Licensed
Compounds and Licensed Products in the ZAI Territory, for use by TESARO to
Develop, manufacture and Commercialize the Licensed Compounds and Licensed
Products in the TESARO Territory.   

(c)        Disclosure of Inventions.  Each Party shall promptly disclose to the
other Party all Sole Inventions of such Party and also Joint Invention,
including any invention disclosures, or other similar documents, submitted to it
by its employees, agents or independent contractors describing such Inventions,
and shall promptly respond to reasonable request from the other Parties for
additional information relating to such Inventions.

10.2 Patent Prosecution. 

(a)        TESARO Patents.  As between the Parties, TESARO shall have the first
right to file, prosecute and maintain, at its own cost and expense, all TESARO
Patents that are not Joint Patents.  TESARO shall consult with ZAI and keep ZAI
reasonably informed of the status of such TESARO Patents in the ZAI Territory
and shall promptly provide ZAI with all material correspondence received from
any patent authority in connection therewith.  In addition,

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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TESARO shall promptly provide ZAI with drafts of all proposed material filings
and correspondence to any patent authority with respect to such TESARO Patents
in the ZAI Territory for review and comment prior to the submission of such
proposed filings and correspondences.  TESARO shall confer with ZAI and consider
in good faith ZAI’s comments prior to submitting such filings and
correspondences.  TESARO shall notify ZAI of any decision to cease prosecution
and/or maintenance of any such TESARO Patents in the ZAI Territory at least
thirty (30) days prior to any filing deadline or payment due date.  In such
event, TESARO shall permit ZAI, at its discretion and at its sole expense, to
continue prosecution or maintenance of such TESARO Patent. 

(b)        Joint Patents.  Each Party shall have the first right to file,
prosecute and maintain, at its own cost and expense, all Joint Patents in its
Territory.  Each Party shall consult with the other Party and keep the other
Party reasonably informed of the status of the Joint Patents in its Territory
and shall promptly provide the other Party with all material correspondence
received from any patent authority in connection therewith.  In addition, each
Party shall promptly provide the other Party with drafts of all proposed
material filings and correspondence to any patent authority with respect to the
Joint Patents in its Territory for review and comment prior to the submission of
such proposed filings and correspondences.  Each Party shall confer with the
other Party and consider in good faith the other Party’s comments prior to
submitting such filings and correspondences.  Each Party shall notify the other
Party of any decision to cease prosecution and/or maintenance of any Joint
Patents in its Territory at least thirty (30) days prior to any filing deadline
or payment due date.  In such event, such Party shall permit the other Party, at
its discretion and at its sole expense, to continue prosecution or maintenance
of such Joint Patent.

(c)        ZAI Patents.  Unless otherwise agreed by the Parties in a separate
license agreement pursuant to Section 10.1(b), as between the Parties, ZAI shall
have the sole right to file, prosecute and maintain, at its own cost and
expense, all Patents Covering its Sole Inventions. 

(d)        Cooperation.  Each Party shall provide the other Party all reasonable
coordination, assistance and cooperation in the patent prosecution efforts under
this Agreement, including providing any necessary powers of attorney and
executing any other required documents or instruments for such prosecution. 

10.3 Patent Enforcement.

(a)        Notice and Enforcement by ZAI.  In the event that either Party
becomes aware of a suspected infringement by a Third Party of any TESARO Patents
in the Field within the ZAI Territory, or any declaratory judgment, opposition,
or similar action alleging the invalidity, unenforceability or non-infringement
of any of TESARO Patents in the ZAI Territory (collectively, “Infringement”),
such Party shall notify the other Party promptly.  ZAI shall have the first
right, but not the obligation, to bring and control any legal action in
connection with any Infringement of TESARO Patents in the ZAI Territory at its
own expense and as it reasonably determines appropriate.  TESARO shall have the
right to be represented in any such action by counsel of its choice at its own
expense.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(b)        Enforcement by TESARO.  If ZAI does not to bring a legal action or
otherwise take reasonable measure to stop the Infringement of TESARO Patents in
ZAI Territory within ninety (90) days after the notice provided pursuant to
Section 10.3(a), TESARO shall have the right to bring and control any legal
action in connection with such Infringement in the ZAI Territory at its own
expense as it reasonably determines appropriate after consultation with ZAI. 

(c)        Cooperation.  At the request and expense of the Party bringing the
action under Section 10.3(a) or (b) above, the other Party shall provide
reasonable assistance in connection therewith, including by executing reasonably
appropriate documents, cooperating in discovery and joining as a party to the
action if required.  In connection with any such proceeding, the enforcing Party
shall keep the other Party reasonably informed on the status of such action and
shall not enter into any settlement admitting the invalidity of, or otherwise
impairing the other Party’s rights in, the relevant TESARO Patents without the
prior written consent of the other Party. 

(d)        Cost and Recovery.  The enforcing Party under Section 10.3(a) or (b)
shall be responsible for the cost and expense incurred with the enforcement
action.  Any recoveries resulting from such enforcement action shall be first
applied to reimburse each Party’s cost and expenses in connection
therewith.  Any such recoveries in excess of such cost and expense shall be
retained by the enforcing Party; provided that if ZAI is the enforcing Party,
then such recovery shall be deemed Net Sales and subject to royalty payment to
TESARO under Section 8.3.

10.4 Defense of Third Party Claims.  Subject to Article 12, if a claim is
brought by a Third Party alleging infringement of a Patent of such Third Party
by the Development, manufacture or Commercialization of the Licensed Compounds
and Licensed Products in the ZAI Territory, the Party first having notice of the
claim or assertion shall promptly notify the other Parties, the Parties shall
agree on and enter into an “common interest agreement” wherein such Parties
agree to their shared, mutual interest in the outcome of such potential dispute,
and thereafter, the Parties shall promptly meet to consider the claim or
assertion and the appropriate course of action.  Each Party shall be entitled to
represent itself in any litigation to which it is a party, at its own expense,
unless otherwise agreed upon by the Parties or as otherwise set forth in this
Agreement.

10.5 Bankruptcy Protection.  All licenses granted by a Party to the other Party
under this Agreement are and shall otherwise be deemed to be for purposes of
Section 365(n) of Title 11, United States Code or foreign equivalent laws (the
“Bankruptcy Code”) licenses of rights to “intellectual property” as defined in
Section 101(56) of the Bankruptcy Code.  The Parties shall retain and may fully
exercise all of their respective rights and elections under the Bankruptcy
Code.  Upon the bankruptcy of a Party, the non-bankrupt Party shall further be
entitled to a complete duplicate of, or complete access to, any such
intellectual property, and such, if not already in its possession, shall be
promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects
to continue, and continues, to perform all of its obligations under this
Agreement.  Nothing in this Section 10.5 shall be interpreted as giving any
Party greater rights to the other Party’s intellectual property after the
bankruptcy of the other Party than such Party had prior to such bankruptcy.  

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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11. CONFIDENTIALITY

11.1 Nondisclosure and Non-Use.  Each Party agrees that, for so long as this
Agreement is in effect and for a period of [***] years thereafter, a Party (the
“Receiving Party”) receiving or possessing Confidential Information of the other
Party (the “Disclosing Party”) shall, and shall cause its employees,
representatives, Affiliates, consultants, contractors, agents and Sublicensees
to, (a) maintain in confidence such Confidential Information using not less than
the efforts such Receiving Party uses to maintain in confidence its own
proprietary industrial information of similar kind and value (but no less than
reasonable care), (b) not disclose such Confidential Information to any Third
Party without the prior written consent of the Disclosing Party, except for
disclosures expressly permitted below, and (c) not use such Confidential
Information for any purpose except those permitted by this Agreement, including
in connection with exercising its rights or fulfilling its obligations under
this Agreement (it being understood that this clause (c) shall not create or
imply any rights or licenses not expressly granted under Article ‎0
hereof).  Each Receiving Party shall be responsible for any breach of these
obligations by any of its employees, representatives, Affiliates, consultants,
contractors, agents and Sublicensees to which it discloses or provides access to
any Confidential Information of the Disclosing Party.  Each Receiving Party
shall take all reasonable action under Applicable Law to enforce the
confidentiality obligations hereunder against any employees, representatives,
Affiliates, consultants, contractors, agents and Sublicensees to which it
discloses or provides access to any Confidential Information of the Disclosing
Party.

11.2 Confidentiality of TESARO Know-How.  During such time as the license to ZAI
under the TESARO Know-How granted under Section ‎2.1 is in effect, solely for
disclosure purposes to Third Parties, the TESARO Know-How shall be deemed to be
Confidential Information of both TESARO and ZAI under Article ‎11, both TESARO
and ZAI shall be deemed to be a Disclosing Party of the TESARO Know-How under
Article ‎11, and TESARO and its Affiliates shall be deemed not to have known
such TESARO Know-How prior to disclosure for the purposes of Section ‎0. 

11.3 Exceptions.  The obligations in Section ‎11.1 shall not apply with respect
to any portion of the Confidential Information that the Receiving Party can show
by competent proof:

(a)        was known to the Receiving Party or any of its Affiliates, without
any obligation to keep it confidential or any restriction on its use, prior to
disclosure by the Disclosing Party; or

(b)        was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the Receiving Party;

(c)        became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or omission of
the Receiving Party in breach of this Agreement; or

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(d)        is subsequently disclosed to the Receiving Party or any of its
Affiliates by a Third Party lawfully in possession thereof and without any
obligation to keep it confidential or any restriction on its use; or

(e)        has been independently developed by employees or contractors of the
Receiving Party or any of its Affiliates without the aid, application or use of
Confidential Information of the Disclosing Party as demonstrated by documented
evidence prepared contemporaneously with such independent development.

11.4 Authorized Disclosure.  The Receiving Party may disclose Confidential
Information belonging to the Disclosing Party to the extent (and only to the
extent) such disclosure is reasonably necessary in the following instances:

(a)        preparing, filing or prosecuting Patents; preparing, filing or
prosecuting Regulatory Materials with respect to obtaining and maintaining
Regulatory Approval of the Licensed Products; and prosecuting or defending
litigation;

(b)        subject to Section 11.7, complying with Applicable Law (including,
without limitation, the rules and regulations of any national securities
exchange, regulations of the State Administration of Foreign Exchange of the
People’s Republic of China, and the State Intellectual Property Office of the
People’s Republic of China) and with judicial process, if in the reasonable
opinion of the Receiving Party’s counsel, such disclosure is necessary for such
compliance, provided that the Receiving Party shall promptly notify the other
Party of such required disclosure so that the Disclosing Party can seek a
protective order or other appropriate remedies and, at the Disclosing Party’s
request and expense, reasonably assist the Disclosing Party in seeking such
protective order or other reasonable remedies; and

(c)        disclosure (i) in connection with the performance of this Agreement
and solely on a “need to know basis”, to Affiliates, potential or actual
collaborators (including potential Sublicensees), or employees, contractors, or
agents; or (ii) solely on a “need to know basis” to potential or actual
investment bankers, consultants, advisors, investors, partners, collaborators,
lenders, or acquirers; each of whom in the case of clause (i) or (ii) prior to
disclosure must be bound by written obligations of confidentiality and non-use
no less restrictive than the obligations set forth in this Article ‎11.

11.5 Terms of this Agreement.  The Parties acknowledge that the terms of this
Agreement shall be treated as Confidential Information of both Parties.

11.6 Prior CDA.  This Agreement supersedes the Mutual Confidentiality and
Non-Use Agreement between the Parties dated October 12, 2015 (the “Prior CDA”)
with respect to information disclosed thereunder.  All information exchanged
between the Parties under the Prior CDA shall be deemed Confidential Information
of the disclosing Party and shall be subject to the terms of this Article ‎11.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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11.7 Securities Filings.  In the event either Party proposes to file with the
Securities and Exchange Commission or the securities regulators of any state,
country, province or other jurisdiction a registration statement or any other
disclosure document which describes or refers to this Agreement under the
Securities Act of 1933, as amended, the Securities Exchange Act, of 1934, as
amended, or any other Applicable Law, such Party shall notify the other Party of
such intention and shall provide such other Party with a copy of relevant
portions of the proposed filing not less than five (5) business days prior to
such filing (and any revisions to such portions of the proposed filing a
reasonable time prior to the filing thereof), including any exhibits thereto
relating to this Agreement, and shall use reasonable efforts to obtain
confidential treatment of any information concerning this Agreement that such
other Party requests be kept confidential, and shall only disclose Confidential
Information of the Disclosing Party which it is advised by counsel is legally
required to be disclosed.  No such notice shall be required under this
Section 11.7 if the substance of the description of or reference to this
Agreement contained in the proposed filing has been included in any previous
filing made by the other Party hereunder or otherwise approved by the other
Party.

11.8 Technical Publication.  No Party may publish peer reviewed manuscripts, or
give other forms of public disclosure such as abstracts and presentations, of
results of studies carried out under this Agreement, without the opportunity for
prior review by the other Parties, except to the extent required by Applicable
Laws.  A Party seeking publication of results of studies carried out under this
Agreement shall provide the other Party the opportunity to review and comment on
any proposed publication which relates to the Licensed Product at least thirty
(30) days prior to its intended submission for publication.  The other Party
shall provide the Party seeking publication with its comments in writing, if
any, within twenty (20) days after receipt of such proposed publication.  The
Party seeking publication shall consider in good faith any comments thereto
provided by the other Party and shall comply with the other Party’s request to
remove any and all of such other Party’s Confidential Information from the
proposed publication.  In addition, the Party seeking publication shall delay
the submission for a period up to sixty (60) days in the event that the other
Party can demonstrate reasonable need for such delay, including without
limitation, the preparation and filing of a patent application.  If the other
Party fail to provide its comments to the Party seeking publication within such
twenty (20) day period, such other Party shall be deemed to not have any
comments, and the Party seeking publication shall be free to publish in
accordance with this Section 11.8 after the thirty (30) day period has
elapsed.  The Party seeking publication shall provide the other Party a copy of
the manuscript at the time of the submission.  Each Party agrees to acknowledge
the contributions of the other Party and its employees in all publications as
scientifically appropriate.

11.9 Equitable Relief.  Each Receiving Party acknowledges and agrees that a
breach of this Article 11 cannot reasonably or adequately be compensated in
damages in an action at law and that such a breach shall cause the Disclosing
Party irreparable injury and damage.  By reason thereof, the Parties agree that
each Party shall be entitled, in addition to any other remedies it may have
under this Agreement or otherwise, to preliminary and permanent injunctive and
other equitable relief to prevent or curtail any breach of the obligations
relating to Confidential Information set forth herein. 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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12. INDEMNITY AND INSURANCE

12.1 Indemnification by ZAI.  ZAI hereby agrees to defend, hold harmless and
indemnify TESARO, its Affiliates, directors, officers, employees and agents from
and against any and all Third Party claims, suites, proceedings, damages,
expenses, liabilities, and/or losses, including without limitation reasonable
legal expenses and attorneys’ fees (collectively “Claims”) to the extent
resulting from or arising out of:  (a) the negligence, willful misconduct or
breach of this Agreement by ZAI; (b) ZAI’s Development, manufacture and
Commercialization of the Licensed Compounds and Licensed Products in ZAI
Territory; (c) any action or omission of ZAI that causes a breach of or results
in non-compliance the Upstream Agreements, except in each case to the extent
such Claims result from or arise out of any activities set forth in Section 12.2
for which TESARO is obligated to indemnify ZAI.

12.2 Indemnification by TESARO.  TESARO hereby agrees to defend, hold harmless
and indemnify ZAI, its Affiliates, directors, officers, employees and agents
from and against any and all Third Party Claims to the extent resulting from or
arising out of:  (a) the negligence, willful misconduct or breach of this
Agreement by TESARO; (b) TESARO’s Development, manufacture and Commercialization
of the Licensed Compounds and Licensed Products in TESARO Territory; and (c)
TESARO’s Development, manufacture and Commercialization of the Licensed
Compounds and Licensed Products prior to the Effective Date; except in each case
to the extent such Claims result from or arise out of any activities set forth
in Section 12.1 for which ZAI is obligated to indemnify TESARO.

12.3 Indemnification Procedure.  The indemnified Party shall provide the
indemnifying Party with prompt notice of the claim giving rise to the
indemnification obligation pursuant to this Article 12 and the exclusive ability
to defend (with the reasonable cooperation of the indemnified Party) or settle
any such claim; provided, however, that the indemnifying Party shall not enter
into any settlement for damages other than monetary damages without the
indemnified Party’s written consent, such consent not to be unreasonably
withheld.  The indemnified Party shall have the right to participate, at its own
expense and with counsel of its choice, in the defense of any claim or suit that
has been assumed by the indemnifying Party.  If the Parties cannot agree as to
the application of Sections 12.1 and 12.2 to any particular Claim, the Parties
may conduct separate defenses of such claim and reserve the right to claim
indemnity from the other in accordance with Sections 12.1 and 12.2 above upon
resolution of the underlying claim, notwithstanding the provisions of this
Section 12.3 requiring the indemnified Party to tender to the indemnifying Party
the exclusive ability to defend such claim or suit.

12.4    Mitigation of Loss.  Each indemnified Party shall take and shall procure
that its Affiliates, agents, directors, officers and employees take all such
reasonable steps and action as are reasonably necessary or as the indemnifying
Party may reasonably require in order to mitigate any Claims (or potential
losses or damages) under this Article 12.  Nothing in this Agreement shall or
shall be deemed to relieve any Party of any common law or other duty to mitigate
any losses incurred by it. 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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12.5 Insurance.  Each Party shall procure and maintain insurance, including
product liability insurance, adequate to cover its obligations hereunder and
which are consistent with normal business practices of prudent companies
similarly situated at all times during which any Licensed Product is being
clinically tested in human subjects or commercially distributed or sold by such
Party.  It is understood that such insurance shall not be construed to create a
limit of either Party’s liability with respect to its indemnification
obligations under this Article 12.  Each Party shall provide the other Party
with written evidence of such insurance upon request.  Each Party shall provide
the other Party with written notice at least thirty (30) days prior to the
cancellation, non-renewal or material change in such insurance which materially
adversely affects the rights of the other Party hereunder.

13. TERM AND TERMINATION

13.1 Term.  This Agreement shall commence as of the Effective Date and, unless
sooner terminated in accordance with the terms hereof or by mutual written
consent, shall continue, on a country-by-country and Licensed
Product-by-Licensed Product basis, until the expiration of the Royalty Term for
such Licensed Product in such country (the “Term”).  After the expiration (but
not early termination) of the Term, the licenses granted by TESARO to ZAI
hereunder shall become full paid, royalty free, perpetual and irrevocable. 

13.2 Termination.

(a)        Termination for convenience.  At any time, ZAI may terminate this
Agreement by providing written notice of termination to TESARO, which notice
includes an effective date of termination at least [***] after the date of the
notice.

(b)        Termination for Material Breach.  Each Party shall have the right to
terminate this Agreement in its entirety immediately upon written notice to the
other Party if the other Party materially breaches its material obligations
under this Agreement and, after receiving written notice identifying such
material breach in reasonable detail, fails to cure such material breach within
[***] from the date of such notice, provided that, if such other Party dispute
such alleged breach in good faith, such termination shall not become effective
unless and until such dispute has been resolved in favor of the Party providing
notice of such termination and such other Party has not cured such material
breach within [***] after such resolution.

(c)        Termination for Insolvency.  Each Party shall have the right to
terminate this Agreement in its entirety immediately upon written notice to the
other Party if (i) such other Party files in any court or agency pursuant to any
statute or regulation of any jurisdiction a petition in bankruptcy or insolvency
or for reorganization or similar arrangement for the benefit of creditors or for
the appointment of a receiver or trustee of such other Party or its assets,
(ii) such other Party is served with an involuntary petition against it in any
insolvency proceeding, and upon the [***] after such service, such involuntary
petition has not been stayed or dismissed, or (iii) such other Party makes an
assignment of substantially all of its assets for the benefit of its creditors. 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(d)        Termination by Mutual Agreement.  The Parties may also terminate this
Agreement by mutual agreement.

13.3 Effect of Termination.  Upon the early termination of this Agreement
pursuant to Section 13.2: 

(a)        License to ZAI.  All licenses and other rights granted by TESARO to
ZAI shall terminate, and all rights of ZAI under the TESARO Patents and TESARO
Know-How shall revert to TESARO.    

(b)        License to TESARO.  ZAI shall grant to TESARO (with the right to
grant sublicenses through multiple tiers) an exclusive license under ZAI’s Sole
Inventions and ZAI’s right and interest in and to any Joint Inventions,
including the Data generated by ZAI from the Development of the Licensed
Compounds and Licensed Products under this Agreement, for use by TESARO (or its
sublicensees) to Develop, manufacture and Commercialize the Licensed Compounds
and Licensed Products in the TESARO Territory.  The terms and conditions of such
a license may include, at TESARO’s request, the transfer of Regulatory
Materials, inventories, and/or ongoing clinical trials to TESARO, as well as
reasonable transition assistance.  The foregoing license and transfer shall be
royalty-free and without payment from TESARO other than (i) the payment by
TESARO of the reasonable cost of any transition assistance (such costs to be
consistent with industry custom, and (ii) if: (A) ZAI terminates this Agreement
under 13.2(b), he license shall be royalty-bearing (such royalties to be
consistent with other royalty-bearing royalties for similar intellectual
property rights) and otherwise on commercially reasonable terms.

13.4 Transfer of Data and Regulatory Materials; Wind-down of Clinical
Activities.  Without limiting the obligations of the Parties under Section 13.3
above, upon the effective date of the termination of this Agreement, ZAI shall
transfer to TESARO, at TESARO’s business premises, all Data and Regulatory
Materials related to the Licensed Compounds or Licensed Products.  Additionally,
with respect to any ongoing clinical trials of Licensed Products each Party
shall cooperate with the other Party to facilitate the orderly transfer to
TESARO of the conduct of such clinical trials as soon as reasonably practicable,
(ii) until such time as the conduct of such clinical trials has been
successfully transferred to TESARO, ZAI shall continue such clinical trials,
(iii) between the effective date of termination and the date on which the
conduct of such clinical trials has been successfully transferred to TESARO, ZAI
shall be responsible for all costs and expenses reasonably incurred by ZAI in
the conduct of such clinical trials, and (iv) following the date on which the
conduct of such clinical trials has been successfully transferred to TESARO,
TESARO shall be solely responsible for all costs and expenses of such ongoing
clinical trials.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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13.5 Survival.  Termination or expiration of this Agreement shall not relieve
the Parties of any liability or obligation which accrued hereunder prior to the
effective date of such termination or expiration nor preclude either Party from
pursuing all rights and remedies it may have hereunder or at law or in equity,
subject to Section ‎14.2, with respect to any breach of this Agreement nor
prejudice either Party’s right to obtain performance of any obligation.  The
following provisions shall survive termination or expiration of this Agreement,
as well as any other provision which by its terms or by the context thereof, is
intended to survive such termination: Articles 1, 10, 11, and 15, and Sections
9.6, 9.7, 13.3, 13.4 and 13.5..

14. DISPUTE RESOLUTION

14.1 Internal Resolution.  Other than disputes subject to the final resolution
by the JSC or Executives pursuant to  Section 3.5 or determinations made by
certified accountants as provided in Section ‎8.7, in the event of any dispute
between the Parties relating to or arising out of this Agreement, the formation,
construction, breach or termination hereof, or the rights, duties or liabilities
of either Party hereunder, the Parties shall first attempt in good faith to
resolve such dispute by negotiation and consultation between themselves,
utilizing the Alliance Managers.  In the event that such dispute is not resolved
on an informal basis within thirty (30) days, either Party may, by written
notice to the other Party, refer the dispute to the Executive Officers for
attempted resolution by good faith negotiation within thirty (30) days after
such notice is received.

14.2 Binding Arbitration.  If the Executive Officers are not able to resolve
such disputed matter within thirty (30) days and any Party wishes to pursue the
matter, each such dispute, controversy or claim that is not an Excluded Claim
(defined in Section 14.3 below) shall be finally resolved by binding arbitration
administered by the International Chamber of Commerce (“ICC”) pursuant its
arbitration rules, and judgment on the arbitration award may be entered in any
court having jurisdiction thereof.  The Parties agree that:

(a)        The arbitration shall be conducted by a single arbitrator appointed
by the ICC, who shall be experienced in the pharmaceutical business in the
relevant country.  The place of arbitration shall be New York, New York, and all
proceedings and communications shall be in English, unless otherwise agreed by
all Parties involved in such dispute.

(b)        Any Party may apply to the arbitrators for interim injunctive relief
until the arbitration award is rendered or the controversy is otherwise
resolved.  Any Party also may, without waiving any remedy under this Agreement,
seek from any court having jurisdiction any injunctive or provisional relief
necessary to protect the rights or property of that Party pending the
arbitration award. 

(c)        The arbitrator shall have no authority to award punitive or any other
type of damages not measured by a Party’s compensatory damage.  Each Party shall
bear its own costs and expenses and attorneys’ fees and an equal share of the
arbitrator’s fees and any administrative fees of arbitration regardless of the
outcome of such arbitration. 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(d)        Except to the extent necessary to confirm an award or as may be
required by law, neither a Party nor the arbitrator may disclose the existence,
content, or results of an arbitration without the prior written consent of all
Parties.  In no event shall an arbitration be initiated after the date when
commencement of a legal or equitable proceeding, based on the dispute,
controversy or claim, would have been barred by the applicable statute of
limitations.

14.3 Excluded Claim.  As used in Section 14.2, the term “Excluded Claim” shall
mean a dispute, controversy or claim that concerns the scope, validity,
enforceability, inventorship or infringement of a patent, patent application,
trademark or copyright.  Any Excluded Claim shall be submitted to a court of
competent jurisdiction.

15. MISCELLANEOUS

15.1 Severability.  If any one or more of the provisions of this Agreement is
held to be invalid or unenforceable, the provision shall be considered severed
from this Agreement and shall not serve to invalidate any remaining provisions
hereof.  The Parties shall make a good faith effort to replace any invalid or
unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be
realized.

15.2 Notices.  Any notice required or permitted to be given by this Agreement
shall be in writing and shall be delivered by hand or overnight courier with
tracking capabilities or mailed postage prepaid by first class, registered or
certified mail addressed as set forth below unless changed by notice so given:

If to ZAI:

Zai Lab (Shanghai) Co., Ltd.
1043 Halei Road, Building 8, Suite 502, Pudong, Shanghai, P.R. China, 201203
[***]

With a copy to:

Lila Hope, Ph.D.
Cooley LLP
3175 Hanover Street
Palo Alto, CA  94304-1130
[***]

 

If to TESARO:

 

TESARO Inc.
1000 Winter Street, Suite 3300

Waltham, MA 02451
[***]

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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With a copy to:

 

Asher Rubin

Hogan Lovells US LLP

100 International Drive, Suite 2000

Baltimore, MD 21201
[***]

Any such notice shall be deemed given on the date received.  A Party may add,
delete, or change the person or address to whom notices should be sent at any
time upon written notice delivered to the Party’s notices in accordance with
this Section ‎15.2.

15.3 Force Majeure.  Neither Party shall be liable for delay or failure in the
performance of any of its obligations hereunder if such delay or failure is due
to causes beyond its reasonable control, including, without limitation, acts of
God, fires, earthquakes, strikes and labor disputes, acts of war, terrorism,
civil unrest or intervention of any governmental authority (“Force Majeure”);
provided, however, that the affected Party promptly notifies the other Party and
further provided that the affected Party shall use its commercially reasonable
efforts to avoid or remove such causes of non-performance and to mitigate the
effect of such occurrence, and shall continue performance with the utmost
dispatch whenever such causes are removed.  When such circumstances arise, the
Parties shall negotiate in good faith any modifications of the terms of this
Agreement that may be necessary or appropriate in order to arrive at an
equitable solution.

15.4 Assignment.    Neither Party may assign this Agreement to a Third Party
without the other Party’s prior written consent (such consent not to be
unreasonably withheld); except that TESARO may make such an assignment without
ZAI’s consent to a successor to substantially all of the business of such Party
to which this Agreement relates (whether by merger, sale of stock, sale of
assets or other transaction) and either Party may assign this Agreement to an
Affiliate without the other Party’s consent.  This Agreement shall inure to the
benefit of and be binding on the Parties’ successors and permitted assigns.  Any
assignment or transfer in violation of this Section ‎15.4 shall be null and void
and wholly invalid, the assignee or transferee in any such assignment or
transfer shall acquire no rights whatsoever, and the non-assigning
non-transferring Party shall not recognize, nor shall it be required to
recognize, such assignment or transfer.

15.5 Further Assurances.  Each Party agrees to do and perform all such further
acts and things and shall execute and deliver such other agreements,
certificates, instruments and documents necessary or that the other Party may
deem advisable in order to carry out the intent and accomplish the purposes of
this Agreement and to evidence, perfect or otherwise confirm its rights
hereunder.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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15.6 Waivers and Modifications.  The failure of any Party to insist on the
performance of any obligation hereunder shall not be deemed to be a waiver of
such obligation.  Waiver of any breach of any provision hereof shall not be
deemed to be a waiver of any other breach of such provision or any other
provision on such occasion or any succeeding occasion.  No waiver, modification,
release or amendment of any obligation under or provision of this Agreement
shall be valid or effective unless in writing and signed by all Parties hereto.

15.7 Choice of Law.  This Agreement shall be governed by, enforced, and shall be
construed in accordance with the laws of the State of New York, U.S. without
regard to its conflicts of law provisions.    

15.8 Publicity.  Neither Party shall issue any press release or public statement
disclosing the existence of this Agreement or any other information relating to
this Agreement, the other Party, or the transactions contemplated hereby without
the prior written consent of the other Party, provided, however, that any
disclosure which is required by Applicable Law or the rules of a securities
exchange, as reasonably advised by the disclosing Party’s counsel, may be made
subject to the following.  The Parties agree that any such required disclosure
will not contain confidential business or technical information and, if
disclosure of confidential business or technical information is required by
Applicable Law, the Parties will use appropriate diligent efforts to minimize
such disclosure and obtain confidential treatment for any such information which
is disclosed to a governmental agency.  Each Party agrees to provide to the
other Party a copy of any public announcement regarding this Agreement or the
subject matter thereof as soon as reasonably practicable under the circumstances
prior to its scheduled release.  Except under extraordinary circumstances, or as
otherwise required under Applicable Law or the rules of a securities exchange,
each Party shall provide the other with an advance copy of any such announcement
at least five (5) business days prior to its scheduled release.  Each Party
shall have the right to expeditiously review and recommend changes to any such
announcement and, except as otherwise required by Applicable Law or the rules of
a securities exchange, the Party whose announcement has been reviewed shall
remove any Confidential Information of the reviewing Party that the reviewing
Party reasonably deems to be inappropriate for disclosure.  The contents of any
announcement or similar publicity which has been reviewed and approved by the
reviewing Party can be re-released by either Party without a requirement for
re-approval.  Nothing in this Section ‎15.8 shall be construed to prohibit ZAI
or its Affiliates or Sublicensees from making a public announcement or
disclosure regarding the stage of development of Licensed Product(s) in ZAI’s
(or its Affiliates’ or Sublicensees’) product pipeline or disclosing clinical
trial results regarding such Licensed Product(s), as may be required by
Applicable Law or the rules of a securities exchange, as reasonably advised by
ZAI’s (or its Affiliates’ or Sublicensees’) counsel.

15.9 Relationship of the Parties.  Each Party is an independent contractor under
this Agreement.  Nothing contained herein is intended or is to be construed so
as to constitute TESARO and ZAI as partners, agents or joint venturers.  Neither
Party shall have any express or implied right or authority to assume or create
any obligations on behalf of or in the name of the other Party or to bind the
other Party to any contract, agreement or undertaking with any Third Party.

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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15.10 Headings.  Headings and captions are for convenience only and are not be
used in the interpretation of this Agreement.

15.11 Entire Agreement.  This Agreement (including all Exhibits attached hereto,
which are incorporated herein by reference) (a) sets forth all of the covenants,
promises, agreements, warranties, representations, conditions and understandings
between the Parties hereto with respect to the subject matter hereof,
(b) constitutes and contains the complete, final and exclusive understanding and
agreement of the Parties with respect to the subject matter hereof, and
(c) cancels, supersedes and terminates all prior agreements (including the Prior
CDA) and understanding between the Parties with respect to the subject matter
hereof.  There are no covenants, promises, agreements, warranties,
representations, conditions or understandings with respect to the subject
hereof, whether oral or written, between the Parties other than as set forth
herein.  No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties hereto unless reduced to writing and
signed by the respective authorized officers of the Parties.

15.12 Counterparts.  This Agreement may be executed in counter-parts with the
same effect as if both Parties had signed the same document.  All such
counterparts shall be deemed an original, shall be construed together and shall
constitute one and the same instrument.

15.13 Registration.  If required by Applicable Law, ZAI shall be responsible for
the registration of this Agreement with all applicable Regulatory Authorities in
the ZAI Territory. TESARO shall reasonably cooperate with ZAI in obtaining any
such registrations, including providing relevant documents required by the
applicable Regulatory Authorities in the ZAI Territory. Upon successful
registration of this Agreement with each applicable Regulatory Authority in the
ZAI Territory, ZAI shall promptly forward to TESARO copies of any registration
certificates as well as any other documentation received by ZAI.

15.14 Interpretation.

(a)        Each of the Parties acknowledges and agrees that this Agreement has
been diligently reviewed by and negotiated by and between them, that in such
negotiations each of them has been represented by competent counsel and that the
final agreement contained herein, including the language whereby it has been
expressed, represents the joint efforts of the Parties hereto and their
counsel.  Accordingly, in interpreting this Agreement or any provision hereof,
no presumption shall apply against any Party hereto as being responsible for the
wording or drafting of this Agreement or any such provision, and ambiguities, if
any, in this Agreement shall not be construed against any Party, irrespective of
which Party may be deemed to have authored the ambiguous provision.  The English
language version of this Agreement shall control any interpretations of the
provisions of this Agreement.

(b)        The definitions of the terms herein shall apply equally to the
singular and plural forms of the terms defined.  Whenever the context may
require, any pronoun shall include the corresponding masculine, feminine and
neuter forms.  The words “include”,

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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“includes” and “including” shall be deemed to be followed by the phrase “without
limitation” whether or not such phrase is included.  The word “will” shall be
construed to have the same meaning and effect as the word “shall”.  The word
“any” shall mean “any and all” unless otherwise clearly indicated by
context.  The words “day”, “quarter” or “year” means a calendar day, quarter or
year, as applicable, unless otherwise specified.

(c)        Unless the context requires otherwise, (i) any definition of or
reference to any agreement, instrument or other document herein shall be
construed as referring to such agreement, instrument or other document as from
time to time amended, supplemented or otherwise modified (subject to any
restrictions on such amendments, supplements or modifications set forth herein
or therein), (ii) any reference to any Applicable Law herein shall be construed
as referring to such Applicable Law as from time to time enacted, repealed or
amended, (iii) any reference herein to any person shall be construed to include
the person’s successors and assigns, (iv) the words “herein”, “hereof” and
“hereunder”, and words of similar import, shall be construed to refer to this
Agreement in its entirety and not to any particular provision hereof, and (v)
all references herein to Articles, Sections or Exhibits, unless otherwise
specifically provided, shall be construed to refer to Articles, Sections and
Exhibits of this Agreement.

 

[Signature Page Follows]

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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IN WITNESS WHEREOF, the Parties have caused this License Agreement to be
executed by their respective duly authorized officers.

Zai Lab (Shanghai) Co., Ltd.

By:        /s/ Samantha Du

Name:  Samantha Du

Title:    CEO

TESARO, Inc.

By:       /s/ Leon O. Moulder Jr.

Name:  Leon O. Moulder Jr.

Title:    CEO

TESARO DEVELOPMENT Ltd.

By:       /s/ Joseph Farmer

Name:  Joseph Farmer

Title:    Director

 

 

 

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Exhibit A

 

[***]

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Exhibit B

 

[***]

 

 

[***] INDICATES TWO PAGES OF MATERIAL THAT WAS OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Exhibit C:  Transferred Materials

 

[***]

 

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Exhibit D:Development Plan - Niraparib Clinical development plan in China

 

[***]

 

 

[***] INDICATES TWO PAGES OF MATERIAL THAT WAS OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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