Exhibit 10.1

 

[***] 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.

 

 

COLLABORATION AND LICENSE AGREEMENT

 

BY AND BETWEEN

 

TESARO, INC.

 

AND

 

JANSSEN BIOTECH, INC.

 

 

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TABLE OF CONTENTS

 

 

 

Page

Article 1 DEFINITIONS

1 

 

 

Article 2 GOVERNANCE

22 

 

 

2.1 Joint Steering Committee

22 

2.2 Joint Development Committee

25 

2.3 Joint Commercialization Committee

28 

2.4 Joint Manufacturing Committee

30 

2.5 Joint Finance Committee

31 

2.6 Committee Membership and Operations

33 

2.7 Additional Subcommittees

35 

2.8 Authority

35 

2.9 Alliance Managers

35 

2.10 Compliance with Merger Control Laws

35 

 

 

Article 3 LICENSES

36 

 

 

3.1 Licenses to Company

36 

3.2 License to TESARO

39 

3.3 [***]

40 

3.4 Retained Rights

41 

3.5 No Implied Licenses

41 

3.6 [***]

41 

 

 

Article 4 DEVELOPMENT

43 

 

 

4.1 General

43 

4.2 Development Activities

43 

4.3 Development Diligence Obligations

47 

4.4 Compliance with Law

48 

4.5 Records

48 

4.6 Subcontracting

49 

4.7 Audits

49 

 

 

Article 5 REGULATORY RESPONSIBILITIES

49 

 

 

5.1 General

49 

5.2 Regulatory Activities – General

50 

5.3 INDs and Marketing Approvals

51 

5.4 Interactions with Regulatory Authorities

57 

 

Confidential

i

 

 

[***] 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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5.5 Sharing of Regulatory Documentation

58 

5.6 Rights of Reference

58 

5.7 Adverse Event Reporting and Safety Data Exchange

60 

5.8 Medical Affairs

60 

5.9 Recalls and Voluntary Withdrawals

62 

5.10 Subcontracting

63 

 

 

Article 6 COMMERCIALIZATION

64 

 

 

6.1 General

64 

6.2 Commercialization Activities

64 

6.3 Commercialization Diligence Obligations

67 

6.4 Registration & Distribution Option

67 

6.5 Trademarks; Product Packaging

68 

6.6 Transparency Reporting

68 

6.7 Compliance with Law

69 

6.8 Advertising and Promotional Materials

69 

6.9 Subcontracting

69 

6.10 [***]

69 

 

 

Article 7 MANUFACTURING

70 

 

 

7.1 Single Agent Products

70 

7.2 Fixed Dose Combination Products

71 

7.3 API Supply

71 

7.4 Joint Manufacturing Committee

73 

7.5 Compliance with Law

74 

7.6 Subcontracting; Audit Rights

74 

7.7 Supply Shortages

75 

 

 

Article 8 CONSIDERATION

75 

 

 

8.1 Upfront Payment

75 

8.2 Milestone Payments

76 

8.3 Single Agent Alliance Payments

80 

8.4 Company Royalty Obligations

82 

8.5 Royalty Term

86 

8.6 Royalty Rate Reduction

87 

8.7 Manner of Royalty Payment

87 

8.8 Currency

88 

8.9 Third Party Financial Obligations

89 

8.10 Taxes

92 

8.11 Audit

93 

8.12 [***]

94 

Confidential

ii

 

 

[***] 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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8.13 Other TESARO Invoices to Company

95 

8.14 Invoices

95 

8.15 Late Payment

95 

 

 

Article 9 INTELLECTUAL PROPERTY MATTERS

95 

 

 

9.1 Ownership of Inventions

95 

9.2 Disclosure of Inventions

96 

9.3 Prosecution of Patents

96 

9.4 Patent Term Extensions in the Territory

98 

9.5 Infringement of Patents by Third Parties

99 

9.6 Infringement of Third Party Rights in the Territory

101 

9.7 Patent Oppositions and Other Proceedings

103 

 

 

Article 10 REPRESENTATIONS, WARRANTIES AND COVENANTS

104 

 

 

10.1 Mutual Representations, Warranties and Covenants

104 

10.2 Additional Representations and Warranties of TESARO

105 

10.3 Additional Representations and Warranties of Company

109 

10.4 Merck License Agreement

109 

10.5 Certain Compliance Matters

109 

10.6 No Other Representations or Warranties

110 

 

 

Article 11 CONFIDENTIALITY

110 

 

 

11.1 Nondisclosure and Nonuse

110 

11.2 Exceptions

111 

11.3 Authorized Disclosure

112 

11.4 Terms of this Agreement

112 

11.5 Publicity

113 

11.6 Securities Filings

113 

11.7 Relationship to Confidentiality Agreement and Merck License Agreement

113 

11.8 Equitable Relief

114 

11.9 Publications

114 

11.10 Return of Confidential Information

114 

 

 

Article 12 TERM AND TERMINATION

114 

 

 

12.1 Term

114 

12.2 Termination upon Termination of the Merck License Agreement or Either
AstraZeneca License Agreement

114 

12.3 Unilateral Termination by Company

114 

12.4 Termination for Material Breach

114 

12.5 Termination by Company for Safety Reasons

115 

 

Confidential

iii

 

 

[***] 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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12.6 [Reserved.]

115 

12.7 Termination for Bankruptcy

115 

12.8 [***]

117 

12.9 Effects of Termination

117 

12.10 Remedies

121 

12.11 Survival

121 

 

 

Article 13 DISPUTE RESOLUTION

121 

 

 

13.1 Exclusive Dispute Resolution Mechanism

121 

13.2 Resolution by Executive Officers

121 

13.3 Arbitration

122 

13.4 Provisional Remedies

123 

13.5 Confidentiality

123 

 

 

Article 14 INDEMNIFICATION

123 

 

 

14.1 Indemnification by Company

123 

14.2 Indemnification by TESARO

125 

14.3 Indemnification Procedures

126 

14.4 Insurance

129 

14.5 Limitation of Liability

129 

 

 

Article 15 MISCELLANEOUS

129 

 

 

15.1 Notices

129 

15.2 Governing Law

130 

15.3 [***]

131 

15.4 Assignment

132 

15.5 Designation of Affiliates

132 

15.6 Relationship of the Parties

133 

15.7 Force Majeure

133 

15.8 Entire Agreement; Amendments

133 

15.9 Severability

133 

15.10 English Language

134 

15.11 Waiver and Non-Exclusion of Remedies

134 

15.12 Further Assurance

134 

15.13 Headings

134 

15.14 Construction

134 

15.15 Counterparts

135 

 

Confidential

iv

 

 

[***] 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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LIST OF EXHIBITS

Exhibit 1.63

Initial Compound

Exhibit 1.69

2016 Johnson & Johnson Universal Calendar

Exhibit 1.117

TESARO Patents

Exhibit 4.2(c)

TESARO Development Plan

Exhibit 4.2(f)

TESARO INDs

Exhibit 4.2(h)

Example of Third Party Development Report

Exhibit 5.5(a)

Regulatory Documentation relating to Initial Compound and Initial Product

Exhibit 7.1(a)

Company Supply Requirements and Timeline

Exhibit 8.2(d)

Merck Milestone Payments

Exhibit 8.3

Alliance Payments

Exhibit 8.4(b)(i)(1)

Pass-through Merck Royalty

Attachment 1 to Exhibit 8.4(b)(i)(1)

Merck Compound Patent Rights

Exhibit 8.4(b)(i)(2)

Pass-through AstraZeneca Royalties

[***]

[***]

[***]

[***]

Exhibit 8.4(b)

Summary of Economic Transfers between the Parties

Exhibit 10.2(j)

TESARO Disclosure of Certain Development Activities

Exhibit 10.4

Merck License Agreement Provisions

Exhibit 10.5

Compliance with Laws

Exhibit 11.5

Press Release

 

 

Confidential

v

 

 

[***] 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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COLLABORATION AND LICENSE AGREEMENT

THIS COLLABORATION AND LICENSE AGREEMENT (“Agreement”) is entered into as of
April 5, 2016 (the “Effective Date”), by and between JANSSEN BIOTECH, INC., a
Pennsylvania corporation, having its principal place of business at 800/850
Ridgeview Drive, Horsham, PA 19044 (hereinafter “Company”) and TESARO, INC., a
Delaware corporation having its principal place of business at 1000 Winter
Street, Suite 3300, Waltham, MA 02451 (“TESARO”).  Company and TESARO are
sometimes referred to herein individually as a “Party” and collectively as the
“Parties”.

WHEREAS, TESARO is currently developing a small molecule poly ADP ribose
polymerase (PARP) inhibitor, Niraparib, for certain cancer indications
(including breast cancer and ovarian cancer); 

WHEREAS, Company desires to obtain, and TESARO desires to grant to Company, a
worldwide (excluding Japan), exclusive license to develop and commercialize
Niraparib for prostate cancer indications, subject to the terms and conditions
of this Agreement; and

WHEREAS, TESARO and Company desire to collaborate with respect to the
development, manufacture and commercialization of Niraparib as set forth in this
Agreement.

NOW, THEREFORE, in consideration of the foregoing and the premises and
conditions set forth herein, the Parties agree as follows: 

ARTICLE 1
DEFINITIONS 

1.1“Acquirer” means any Third Party that is an acquirer in any Change of Control
transaction and any of such Third Party’s Affiliates.

1.2“Affiliate” means, with respect to a particular Person and a particular time,
another Person that controls, is controlled by or is under common control with
such first Person at any such time during the Term.  For the purposes of this
definition, the word “control” (including, with correlative meaning, the terms
“controlled by” or “under the common control with”) means the actual power,
either directly or indirectly through one or more intermediaries, to direct or
cause the direction of the management and policies of a Person, whether by the
ownership of fifty percent (50%) or more of the voting stock of such Person, by
contract, or otherwise. 

1.3“Affordable Basis” means making a product available to patients at the lowest
cost possible.  For clarification, Affordable Basis is satisfied if a Party
sells such product for no more than [***].  In determining Affordable Basis, the
Parties recognize that, to the extent that a Party engages a Third Party in the
commercialization of a product on an Affordable Basis, such Third Party shall be
entitled to [***]; provided that the applicable Party uses Commercially
Reasonable Efforts to minimize such Third Party profits.

Confidential

1

 

 

[***] 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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1.4“Alliance Manager” means the person appointed by each Party from within its
respective organization to coordinate and facilitate the communication,
interaction and cooperation of the Parties pursuant to this Agreement.

1.5“ANDA” means an abbreviated new drug application submitted to the FDA
pursuant to 21 U.S.C. § 355(j), and all amendments and supplements thereto

1.6“Applicable Law” means all applicable statutes, ordinances, regulations,
rules or orders of any kind whatsoever of any Governmental Authority, including
the FFDCA, 21 U.S.C. §301 et seq., U.S. Patent Act (35 U.S.C. §1 et seq.),
Federal False Claims Act (31 U.S.C. §3729 et seq.), the Anti-Kickback Statute
(42 U.S.C. §1320a-7b et seq.), Directive 2001/83/EC of the European Parliament
and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use, Directive 2001/20/EC on the approximation of
the laws, regulations and administrative provisions of the EU member states
relating to the implementation of good clinical practice in the conduct of
clinical trials on medicinal products for human use, Commission Directive
2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for
good clinical practice as regards investigational medicinal products for human
use and related guidance, Directive 95/46/EC on the protection of individuals
with regard to the processing of  personal data and on the free movement of such
data, the related national implementing laws and regulations of the EU member
states, provisions of the national laws and industry and professionals codes of
EU member states governing anti-bribery and anti-kickback practices, all as
amended from time to time, together with any rules, regulations, and compliance
guidance promulgated thereunder.

1.7“AstraZeneca” means AstraZeneca UK Limited or any assignee of such entity
under the AstraZeneca License Agreements.

1.8“AstraZeneca License Agreements” means, collectively, (a) the Patent License
Agreement, dated October 4, 2012, between TESARO and AstraZeneca, relating to
certain intellectual property licensed to AstraZeneca by the Institute of Cancer
Research (the “AstraZeneca-ICR License Agreement”), and (b) the Patent License
Agreement, dated October 4, 2012, between TESARO and AstraZeneca, relating to
certain intellectual property licensed to AstraZeneca by the University of
Sheffield (the “AstraZeneca-Sheffield License Agreement”), in each case ((a) and
(b)), including all amendments thereto.

1.9“AstraZeneca Patents” means the “Licensed Patents” as such term is defined in
each of the AstraZeneca License Agreements.

1.10“Business Day” means a day other than Saturday, Sunday or any other day on
which banking institutions in New York, New York are closed for business. 

1.11“Calendar Quarter” means a financial quarter based on the Johnson & Johnson
Universal Calendar; provided,  however, that the first Calendar Quarter for the
first Calendar Year extends from the Effective Date to the end of the
then-current Calendar Quarter and the last

Confidential

2

 

 

[***] 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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Calendar Quarter extends from the first day of such Calendar Quarter until the
effective date of the termination or expiration of this Agreement.

1.12“Calendar Year” means a year based on the Johnson & Johnson Universal
Calendar for that year.  The last Calendar Year of the Term begins on the first
day of the Johnson & Johnson Universal Calendar Year for the year during which
termination or expiration of this Agreement will occur, and the last day of such
Calendar Year will be the effective date of such termination or expiration. 

1.13“Centralized Approval Procedure” means, to the extent compulsory or
permitted for the Marketing Approval of a pharmaceutical product in Iceland,
Liechtenstein, Norway or any country in the European Union, the procedure
administrated by the EMA which results in a single Marketing Approval granted by
the European Commission (excluding any pricing or reimbursement approval) that
is valid in all countries in the European Union and following recognition,
Iceland, Liechtenstein and Norway.

1.14“Change of Control” shall occur if: (a) any Third Party acquires directly or
indirectly the beneficial ownership of any voting security of a Party, or if the
percentage ownership of such person or entity in the voting securities of a
Party is increased through stock redemption, cancellation or other
recapitalization, and immediately after such acquisition or increase such Third
Party is, directly or indirectly, the beneficial owner of voting securities
representing more than fifty percent (50%) of the total voting power of all of
the then outstanding voting securities of a Party; (b) a merger, consolidation,
recapitalization or reorganization of a Party is consummated, other than any
such transaction, which would result in stockholders or equity holders of such
Party immediately prior to such transaction, owning, directly or indirectly, at
least fifty percent (50%) of the outstanding securities of the surviving entity
(or its parent entity) immediately following such transaction; (c) the
stockholders or equity holders of a Party approve a plan of complete liquidation
of such Party, or an agreement for the sale or disposition by such Party of all
or substantially all of such Party’s assets, other than pursuant to a
transaction described above or to an Affiliate; (d) individuals who, as of the
date hereof, constitute the Board of Directors of a Party (the “Incumbent
Board”) cease for any reason to constitute at least a majority of the Board of
Directors of such Party (provided,  however, that any individual becoming a
director subsequent to the date hereof whose election, or nomination for
election by such Party’s shareholders, was recommended or approved by a vote of
at least a majority of the directors then comprising the Incumbent Board shall
be considered as though such individual were a member of the Incumbent Board);
or (e) the sale or transfer to a Third Party of all or substantially all of such
Party’s assets is effected. 

1.15“Clinical Data” means any and all data (anonymized, to the extent required
by Applicable Law or relevant contracts) generated from any Clinical Trial, or
from testing or analysis of subjects or samples from a Clinical Trial (e.g., in
vitro testing of tissue samples from subjects enrolled in a Clinical Trial),
including raw data, any top-line results reports, and the final clinical study
report from such Clinical Trial. 

Confidential

3

 

 

[***] 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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1.16“Clinical Trials” means a Phase 1 Trial, Phase 2 Trial, Phase 2/3 Trial,
Phase 3 Trial or Phase 4 Trial, as applicable.

1.17“CMC Development” means the Development activities related to the
composition, manufacture, and specification of the drug substance and the drug
product intended to assure the proper identification, quality, purity and
strength of the drug, including, but not limited to: test method development and
stability testing, process development, drug substance development, process
validation, process scale-up, formulation development, delivery system
development, quality assurance and quality control development.

1.18“Co-Packaged Product” means any product containing, in a single package or
container and intended for coordinated sale or use, two (2) or more separate
products as components, one (1) of which is a Product and the other one (1) or
more are for preventative, therapeutic, or diagnostic use.

1.19“Combination Product” means any Product containing as a single formulation,
two or more active pharmaceutical ingredients (each, an “API”) as components,
including (i) a Compound and (ii) one or more other APIs.    

1.20“Combination Use” means the use of a Single Agent Product in combination
with at least one other product that is not a Product for the diagnosis,
treatment or prevention of any indication, where such Single Agent Product and
other product are packaged and sold separately.

1.21“Commercialization” means any activities directed to marketing, promoting
and/or Distributing a pharmaceutical product.  When used as a verb,
“Commercialize” means to engage in Commercialization activities.

1.22“Commercially Reasonable Efforts” means, with respect to the efforts and
resources to be expended, or activities to be undertaken, by a Party or its
Affiliate with respect to any objective or activity to be undertaken hereunder,
reasonable efforts and resources intended in good faith to accomplish such
objective or activity as such Party would normally use to accomplish a similar
objective or activity under similar circumstances, it being understood and
agreed that, with respect to the Development, Manufacture, seeking and obtaining
Marketing Approval, or Commercialization of a Compound or Product, such efforts
and resources shall be consistent with those efforts and resources normally used
by a Party under similar circumstances for similar compounds or products to
which it has similar rights, which compound or product, as applicable, is at a
similar stage in its development or product life and is of similar market
potential, taking into account all commercial, scientific, economic and other
factors (not including payments due to a Party hereunder), including:  (a)
issues of efficacy, safety, and expected and actual approved labeling; (b) the
expected and actual competitiveness of alternative products sold by Third
Parties in the marketplace; (c) the expected and actual product profile of the
Compound or Product; (d) the expected and actual patent and other proprietary
position of the Compound or Product; (e) the likelihood of Marketing Approval of
the Product given the regulatory structure involved, including the likelihood of
obtaining regulatory exclusivity; (f) the ability to formulate and Develop
Combination Products; and (g) the market penetration, actual

Confidential

4

 

 

[***] 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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profitability and the return on investment potential of the Product, including
pricing and reimbursement status achieved or likely to be achieved and expected
and actual Third Party costs.  Additionally, neither Party shall take into
account the Alliance Payments, royalties or milestone payments due to the other
Party under this Agreement in connection with its use of Commercially Reasonable
Efforts.  To the extent that the performance of a Party’s obligations hereunder
is adversely affected by the other Party’s failure to perform its obligations
hereunder, the impact of such performance failure will be taken into account in
determining whether such first Party has used Commercially Reasonable Efforts to
perform its affected obligations. 

1.23“Company Field” means the diagnosis, treatment or prevention of prostate
cancer in humans. 

1.24“Company Know-How” means any Know-How Controlled by Company or its
Affiliates during the Term that is used by Company or any of its Affiliates or
(sub)licensees to Exploit the Compounds or Single Agent Products in the Company
Field in the Company Territory, but excluding any such Know-How to the extent
that it (a) is used to Exploit a Compound due to its incorporation or use as
part of a Combination Product, and (b) is not necessary or useful for the
Exploitation of Compounds as Single Agent Products.  

1.25“Company Net Sales” means, with respect to any Product sold by Company or
any of its Affiliates, licensees or sublicensees, the gross amounts invoiced on
sales of such Product by Company or any of its Affiliates, licensees or
sublicensees to a Third Party purchaser in an arms-length transaction, less the
following customary deductions, determined in accordance with GAAP and internal
policies and actually taken, paid, accrued or allocated based on good faith
estimates:

(a)        trade, cash and/or quantity discounts, allowances, and credits,
excluding commissions for commercialization;

(b)        excise taxes, use taxes, tariffs, sales taxes and customs duties,
and/or other government taxes imposed on the sale of Product (including VAT, but
only to the extent that such VAT taxes are not reimbursable or refundable),
specifically excluding, for clarity, any income taxes assessed against the
income arising from such sale;

(c)        outbound freight, shipment and insurance costs to the extent included
in the price and separately itemized on the invoice price;

(d)        [***], cash rebates payable to, or the impact of reimbursement caps
established by, a governmental authority (or agent thereof) pursuant to
governmental regulations by reason of any national or local health insurance
program or similar program, including government levied fees as a result of
healthcare reform policies;

Confidential

5

 

 

[***] 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)        retroactive price reductions, credits or allowances actually granted
upon rejections or returns of Product, including for recalls or damaged goods,
or billing errors and reserves for returns;

(f)        rebates, chargebacks, administrative fees and discounts (or
equivalent thereof) payable to managed health care organizations, group
purchasing organizations, pharmacy benefit managers (or equivalent thereof),
specialty pharmacy providers, federal, state/provincial, local or other
governments, or their agencies or purchasers, reimbursers, or trade customers;

(g)        amounts payable to patients through co-pay assistance cards or
similar forms of rebate directly related to the prescribing of the Product; and

(h)        any invoiced amounts which are not collected by Company or its
Affiliates, including bad debts.

All aforementioned deductions shall only be allowable to the extent they are
commercially reasonable and shall be determined, on a country-by-country basis,
as incurred in the ordinary course of business in type and amount consistent
with Company’s, its Affiliate’s, or Third Party licensee’s or sublicensee’s (as
the case may be) business practices consistently applied across its product
lines and accounting standards and verifiable based on Company’s and its
Affiliates’ sales reporting system. 

Sales of a Product by and between Company and its Affiliates, licensees or
sublicensees are not sales to Third Parties and shall be excluded from Net Sales
calculations for all purposes so long as such Product is subsequently resold to
a Third Party end user.  Sales of a Product on an Affordable Basis in Developing
Countries shall be excluded from Net Sales calculations for purposes of royalty
calculations under ARTICLE 8.  Any disposition of a Product as free samples,
donations, patient assistance, test marketing programs or other similar programs
or studies where such Product is supplied free of charge shall not be subject to
royalties. 

Notwithstanding the foregoing, but subject to Section 3.1(e), with respect to
any Combination Product that is sold by Company or any of its Affiliates,
licensees or sublicensees, the Net Sales of such Combination Product for the
determination of royalties of Combination Products will be calculated by
multiplying the Net Sales of such Combination Product (calculated as set forth
above) by the fraction 1/A, where A is the total number of separate active
pharmaceutical ingredients included in such Combination Product.

1.26“Company Parent” means Johnson & Johnson, a New Jersey corporation.

1.27“Company Patents” means all Patents Controlled by Company or its Affiliates
during the Term that are necessary to Exploit Compounds or the Single Agent
Products in the Company Field in the Company Territory, but excluding any such
Patent to the extent that it (a) Covers such Compound due to its incorporation
or use as part of a Combination Product and (b) is not necessary or useful for
the Exploitation of Compounds as Single Agent Products.

Confidential

6

 

 

[***] 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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1.28“Company Technology” means, collectively, the Company Patents and the
Company Know-How.

1.29“Company Territory” means worldwide, excluding Japan.

1.30“Compound” means (a) the Initial Compound; (b) the compound licensed to
TESARO under the Merck License Agreement and known as MK-2512; or (c) with
respect to both (a) and (b), any pharmaceutically acceptable salt, polymorph,
crystal form, prodrug or solvate thereof.

1.31“Conducting Party” means the Party that is (or the Party whose Affiliate,
licensee or sublicensee is) conducting a Clinical Trial of a Product.

1.32“Confidential Information” means, subject to ARTICLE 11, (a) all non-public
or proprietary information disclosed by a Party to the other Party under this
Agreement, which may include Know-How; and (b) all other non-public or
proprietary information (including Know-How) that is expressly deemed in this
Agreement to be Confidential Information of such Party whether or not disclosed
by such Party or any of its Affiliates to the other Party or any of its
Affiliates; in each case ((a) and (b)) without regard as to whether any of the
foregoing is marked “confidential” or “proprietary,” or disclosed in oral,
written, graphic, or electronic form.  Confidential Information shall include:
(a) the terms and conditions of this Agreement; and (b) Confidential Information
disclosed by either Party pursuant to the Mutual Non-Disclosure Agreement dated
December 29, 2015, between TESARO and Janssen Research & Development LLC, an
Affiliate of Company (the “Prior CDA”). 

1.33“Control” or “Controlled” means, with respect to any Know-How, Patent,
Trademark or other intellectual property right, possession by a Party or[***]
any of its Affiliates, of the ability (without taking into account any rights
granted by one Party to the other Party under the terms of this Agreement) to
grant access, a license or a sublicense to such Know-How, Patent, Trademark or
other intellectual property right without violating the terms of any agreement
or other arrangement with, or necessitating the consent of, any Third Party, but
with respect to TESARO excluding any Know-How, Patent, Trademark or other
intellectual property right that comes into the Control of TESARO pursuant to a
Change of Control of TESARO, except to the extent and only to the extent that,
such Know-How, Patent, Trademark or other intellectual property right is (a) 
made, conceived or reduced to practice by the Acquirer following a Change of
Control through the use of, or reference to, any Know-How, Patent, Trademark or
other intellectual property right Controlled by TESARO prior to the Change of
Control and the failure of Company to have access to such intellectual property
right would prevent Company from exercising its rights under Section 3.1 to
Exploit Compounds and Products, as they existed immediately prior to the Change
of Control; or (b) actually used by TESARO or its Affiliates, or the Acquirer,
to Exploit the Compounds or Products following the consummation of such Change
of Control.  For clarity, “Control” of a compound by a Party shall mean that
such Party Controls Know-How, Patents or other intellectual property rights with
respect to such compound.

1.34“Cover” or “Covering” means, with respect to a product, technology, process
or method, that, in the absence of ownership of or a license granted under a
Valid Claim, the practice or

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[***] 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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Exploitation of such product, technology, process or method would infringe such
Valid Claim (or, in the case of a Valid Claim that has not yet issued, would
infringe such Valid Claim if it were to issue).

1.35“CPR” means the International Institute for Conflict Prevention & Resolution
or any successor organization having substantially the same function.

1.36“Critical Observation” means a significant and meaningful GMP deviation or
deficiency that requires immediate remediation.

1.37“Currency Hedge Rate” means the Johnson & Johnson currency hedge rate[***].
The Johnson & Johnson currency hedge rate is calculated [***]. 

1.38“Developing Countries” means those countries defined by the World Bank as
either “low income countries” or “lower middle income economies” as of the
Effective Date.  If, during the Term, countries reported by the World Bank are
moved in or out of these designations, the Parties will discuss in good faith
the royalty reduction treatment for such countries.

1.39“Development” means all research and non-clinical and clinical drug
development activities and processes, including toxicology, pharmacology,
project management and other non-clinical efforts, statistical analysis,
formulation development, delivery system development, statistical analysis, CMC
Development, the performance of Clinical Trials (including the Manufacturing of
Compound or Product for use in Clinical Trials) and other activities, reasonably
necessary to obtain or maintain Marketing Approval of a pharmaceutical
product.  When used as a verb, “Develop” means to engage in Development
activities.

1.40“Distribution” means offering to sell, selling, distributing, exporting,
transporting and other activities associated with the foregoing activities with
respect to the distribution of a pharmaceutical product, including inventory
management and control, storage, warehousing and distribution, invoicing,
collection of sales proceeds, booking of sales, preparation of sales records and
reports, customer relations and services and handling of returns.  When used as
a verb, “Distribute” means to engage in Distribution activities.

1.41“DMF Equivalent”  means (a) a Drug Master File (as defined in 21 CFR
314.420) with respect to the U.S.; (b) Module 3 of the Common Technical Document
with respect to countries in the EU; or (c) any equivalent of any of the
foregoing with respect to any country outside the U.S. or EU.

1.42“Drug Approval Application” means an MAA or NDA.

1.43“EMA” means the European Medicines Agency or any successor agency(ies) or
authority having substantially the same function.

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[***] 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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1.44“European Commission” means the executive body of the European Union that is
responsible, among other things, for granting marketing authorization for
medicinal products through the Centralized Approval Procedure.

1.45“European Union” or “EU” means the European Union member states as
then-currently constituted; provided,  however, that the EU shall always be
deemed to include the Major EU Countries.  As of the Effective Date, the
European Union member states are Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

1.46“Executive Officers” means (a) with respect to Company, either (i) prior to
the first Marketing Approval of any Product in the Company Field in the Company
Territory, the Global Head of Research and Development (or his or her designee),
and (ii) following the first Marketing Approval of any Product in the Company
Field in the Company Territory, the President of U.S. oncology commercial
operations (or his or her designee), and (b) with respect to TESARO, the Chief
Executive Officer (or his or her designee).

1.47“Exploitation” means research, use, practice, Development, Manufacture or
Commercialization.  When used as a verb, to “Exploit” means to engage in
Exploitation activities.

1.48“FDA” means the U.S. Food and Drug Administration and any successor
agency(ies) or authority having substantially the same function.

1.49“FFDCA” means the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301
et seq.), as amended from time to time.

1.50“Field” means, (a) with respect to Company and its Affiliates and
(sub)licensees, the Company Field, and (b) with respect to TESARO and its
Affiliates and (sub)licensees, the TESARO Field.  References to a “Party’s
Field” shall be interpreted accordingly.

1.51“First Commercial Sale” means, on a Product-by-Product and
country-by-country basis, the first sale for monetary value of such Product
under this Agreement by a Party, its Affiliates, licensees or sublicensees to an
end user for use, consumption or resale of such Product in such country in the
Company Field after Marketing Approval of such Product in the Company Field has
been obtained in such country, where such sale results in a Net Sale.  Sale of a
Product under this Agreement by a Party to an Affiliate of such Party or a
licensee or sublicensee of such Party shall not constitute a First Commercial
Sale unless such Affiliate, licensee or sublicensee is the end user of such
Product.  For the avoidance of doubt, the sale of Product for clinical study
purposes, early access programs (such as to provide patients with a Product
prior to Marketing Approval pursuant to treatment INDs or protocols, named
patient programs or compassionate use programs) or any similar uses shall not
constitute a First Commercial Sale. 

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[***] 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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1.52“Fixed Dose Combination Product” or “FDC” means any Product containing, as a
single formulation, two or more APIs as components, including (a) a Compound and
(ii) one or more other APIs.  For clarity, an FDC is a “Combination Product”
hereunder.

1.53“Force Majeure” means any event beyond the reasonable control of the
affected Party, which may include embargoes; war or acts of war, including
terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other
labor disturbances; epidemics, fire, floods, earthquakes or other acts of
nature; acts, omissions or delays in acting by any Governmental Authority (other
than delays incident to the ordinary course of drug development); and failure of
plant or machinery.

1.54“GAAP” means generally accepted accounting principles in the U.S.,
consistently applied.

1.55“Generic Approval” means, with respect to a pharmaceutical product for which
Marketing Approval has been granted in any country or jurisdiction, a subsequent
Marketing Approval for another pharmaceutical product in such country or any
other country that is granted based upon: (a) reference to an existing Marketing
Approval for such pharmaceutical product (or any of its APIs), or to any
Regulatory Documentation or Clinical Data underlying such existing Marketing
Approval but not including pursuant to a Right of Reference granted under this
Agreement; and (b) in the U.S., that pharmaceutical product is approved with an
“A” rating under an ANDA, or outside of the U.S., that pharmaceutical product is
similarly approved.    

1.56“Generic Version” means, with respect to a given pharmaceutical product and
a given country or jurisdiction, a version of such pharmaceutical product that:
(a) contains the same active pharmaceutical ingredient(s) as such pharmaceutical
product (and no other active pharmaceutical ingredient(s)); (b) has the same
indication; (c) has the same dosage form and strength; (d) is approved for
marketing or sale in such country or jurisdiction pursuant to a Generic
Approval; and (e) is sold by a Third Party in such country pursuant to such
Generic Approval.

1.57“Good Clinical Practices” or “GCP” means the then-current standards,
practices and procedures promulgated or endorsed by the FDA as set forth in 21
C.F.R. Parts 50, 54 and 56 (or any successor statute or regulation), and in the
guideline adopted by the International Conference on Harmonization (“ICH”),
titled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance”
(or any successor document), including related regulatory requirements imposed
by the FDA and comparable regulatory standards, practices and procedures
promulgated by the European Commission or other Regulatory Authority, as they
may be updated from time to time.

1.58“Good Laboratory Practices” or “GLP” means the then-current standards,
practices and procedures promulgated or endorsed by the FDA as set forth in 21
C.F.R. Part 58 (or any successor statute or regulation), including related
regulatory requirements imposed by the FDA and comparable regulatory standards,
practices and procedures promulgated by the European

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[***] 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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Commission or other Regulatory Authority, as they may be updated from time to
time, including applicable guidelines promulgated under the ICH.

1.59“Good Manufacturing Practices” or “GMP” means the then-current good
manufacturing practices required by the FFDCA, as amended, and the regulations
promulgated thereunder by the FDA at 21 C.F.R. Parts 210 and 211, for the
manufacture and testing of pharmaceutical materials, and comparable Applicable
Law related to the manufacture and testing of pharmaceutical materials in
jurisdictions outside the U.S., including the quality guideline promulgated by
the ICH designated ICH Q7A, titled “Q7A Good Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients” and the regulations promulgated thereunder,
in each case as they may be updated from time to time.

1.60“Governmental Authority” means any multi-national, supra-national, federal,
state, local, municipal or other government authority of any nature (including
any governmental division, subdivision, department, agency, bureau, branch,
office, commission, council, court or other tribunal).

1.61“IND” means (a) an Investigational New Drug application as defined in the
FFDCA and applicable regulations promulgated thereunder by the FDA, including 21
C.F.R. Part 312; or (b) a Clinical Trial authorization application or other
documentation filed with a Regulatory Authority in any other country or
jurisdiction outside the U.S., the filing or becoming effective of which (in the
case of (a) or (b)) is necessary to commence or conduct clinical testing of a
pharmaceutical product in humans in such country or jurisdiction. 

1.62“Indication” means a discrete clinically recognized form of a disease in the
Company Field.   For purposes of this Agreement, treatment of different
subpopulations within a population of patients treated for a particular cancer
type/indication or different lines of treatment for the same cancer
type/indication shall also be treated as separate Indications (e.g., front-line
treatment, relapsed refractory treatment and maintenance treatment of the same
disease shall be considered different Indications).

1.63“Initial Compound” means the compound known as Niraparib, as further
described in Exhibit 1.63. 

1.64“Initial Indications” means [***].

1.65“Initial Product” means the Single Agent Product Developed by TESARO prior
to the Effective Date that contains the Initial Compound as its sole active
pharmaceutical ingredient. 

1.66“International Public Organization” means any of the organizations listed in
8 C.F.R. § 316.20, as amended from time to time.

1.67“Invention” means any invention, discovery or development, whether or not
patentable, made, conceived or reduced to practice under this Agreement, whether
made, conceived or

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[***] 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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reduced to practice solely by, or on behalf of, TESARO, Company, the Parties
jointly, or any Affiliate of the same.

1.68“JAA” means any anti-androgen compound Controlled by Company or any of its
Affiliates during the Term or a product containing such compound as a sole
active pharmaceutical ingredient, as the context requires.  For clarity, the
term “JAA” does not include any FDC or other Combination Product containing a
JAA as a component.

1.69“Johnson & Johnson Universal Calendar” means the universal calendar system
used by Company Parent and its Affiliates for internal and external reporting
purposes (a copy of which for the year 2016 is attached hereto as Exhibit 1.69
and a copy of which prior to the beginning of each such year for succeeding
years shall be provided to TESARO). 

1.70“Know-How” means information, inventions, discoveries, formulations,
formulas, practices, procedures, processes, methods, knowledge, know-how, trade
secrets, technology, techniques, designs, drawings, correspondence, computer
programs, documents, apparatus, results, strategies, Regulatory Documentation,
information and submissions pertaining to, or made in association with, filings
with any Governmental Authority, data (including pharmacological, toxicological,
non-clinical data, Clinical Data, analytical and quality control data,
manufacturing data and descriptions, market data, financial data or
descriptions), devices, assays, chemical formulations, specifications, material,
product samples and other samples, physical, chemical and biological materials,
and the like, in written, electronic, oral or other tangible or intangible form,
whether or not patentable.

1.71“Knowledge” means, as applied to a Party, that such Party shall be deemed to
have knowledge of a particular fact or other matter to the extent that a
reasonably prudent person with primary responsibility for the applicable subject
matter (whether an officer or employee of such Party) knew or should have known
of such fact or other matter.

1.72“[***]” means [***].

1.73“[***]” means [***].

1.74“Major EU Countries” means, collectively, France, Germany, Italy, Spain, and
the United Kingdom (whether or not such countries are EU member states).

1.75“Major Markets” mean the U.S., Canada and the Major EU Countries.

1.76“[***]” means [***].

1.77“Manufacture” means all activities and processes related to the
manufacturing of a pharmaceutical product, or any ingredient thereof, including
labeling, packaging, in-process and finished product testing, release of such
pharmaceutical product or any component or ingredient thereof, performance of
quality assurance activities related to manufacturing and release of such
pharmaceutical product, and the performance of ongoing stability tests and
regulatory activities

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[***] 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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related to any of the foregoing.  Where the context so requires, Manufacture
shall also include obtaining product from contract manufacturers subject to the
terms and conditions of this Agreement.  When used as a verb, to “Manufacture”
means to engage in Manufacturing activities.

1.78“Manufacturing Costs” means [***].  Costs included will be consistent with
the activities outlined in Section 1.77 (the “Manufacture” definition).

1.79“Marketing Approval”  means, with respect to a pharmaceutical product and
any country or jurisdiction, any and all: (a) Regulatory Approvals that are
necessary to market or sell such pharmaceutical product in such country or
jurisdiction, including approval of a Drug Approval Application; and (b) pricing
and reimbursement approvals that are necessary to obtain before initiating
Commercialization of such pharmaceutical product in such country or
jurisdiction.  For purposes of illustration with respect to the Major EU
Countries, the following pricing and reimbursement approvals are examples of
those described in clause (b): in France, publication of the reimbursed price
level in the official journal and registration on a reimbursement list by or on
behalf of Comité Economique des Produits de Santé or Haute Autorité de Santé (or
a successor agency); in Italy, publication of reimbursement in the Government’s
Official Gazette (by Agenzia Italiana del Farmaco or a successor agency); in
Germany, execution of contract with the head association of sick funds
(GKV-Spitzenverband, Gesetzlichen Krankenversicherung, or a successor agency);
in Spain, authorization by La Comisión Interministerial de Precios de los
Medicamentos or La Comisión Nacional para el Uso Racional de los Medicamentos
(or a successor agency) for national patient access to reimbursement by or on
behalf of a Governmental Authority; and in the United Kingdom, a recommendation
by the National Institute for Health and Care Excellence (or a successor agency)
to obtain mandatory funding to enable broad market access.    

1.80“Marketing Authorization Application” or “MAA” means an application for
authorization to market and/or sell a drug product submitted to a Regulatory
Authority in any country or jurisdiction other than the U.S., and amendments and
supplements thereto, including, with respect to the European Union, a marketing
authorization application filed with the EMA pursuant to the Centralized
Approval Procedure or with the applicable Regulatory Authority of a country in
the European Economic Area with respect to the decentralized procedure, mutual
recognition or any national approval procedure.

1.81“Merck” means Merck Sharp & Dohme Corp. or any assignee of such entity under
the Merck License Agreement.

1.82“Merck Know-How” has the meaning set forth in the Merck License Agreement.

1.83“Merck License Agreement” means the License Agreement, dated May 22, 2012,
between Merck and TESARO, including all amendments thereto.

1.84“Merck Patents” means the “Compound Patent Rights” as such term is defined
in the Merck License Agreement.

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[***] 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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1.85“Merck Term” means the “Term” of the Merck License Agreement as such term is
defined in the Merck License Agreement.

1.86“Merger Control Laws” means all U.S. federal and state, and any foreign,
statutes, rules, regulations, orders, administrative and judicial doctrines, and
other Applicable Law, relating to antitrust or competition matters, or that are
designed or intended to prohibit, restrict or regulate actions having the
purpose or effect of monopolization or restraint of trade or lessening of
competition.

1.87“Monotherapy Use” means the use of one Single Agent Product alone for the
diagnosis, treatment or prevention of any indication.

1.88“NDA” means a new drug application submitted to the FDA pursuant to Section
505(b) of the FFDCA, 21 U.S.C. § 355(b), and all amendments and supplements
thereto.

1.89“Net Sales” means (a) with respect to any Product sold by Company or any of
its Affiliates, licensees or sublicensees, Company Net Sales and (b) with
respect to any Product sold by TESARO or any of its Affiliates, licensees or
sublicensees, TESARO Net Sales. 

1.90“Orange Book” means, as applicable, the most recent and electronic editions
of the Orange Book: Approved Drug Products with Therapeutic Equivalence
Evaluations.

1.91“Other TESARO Patents” means TESARO Patents other than the Merck Patents and
the AstraZeneca Patents.

1.92“Pass-through Third Party Royalties” means the Pass-through Merck Royalty,
the Pass-through AstraZeneca-ICR Royalty and the Pass-through
AstraZeneca-Sheffield Royalty.

1.93“Patents” means all: (a) patents, including any utility or design patent;
(b) patent applications, including provisionals, substitutions, divisionals,
continuations, continuations in-part or renewals; (c) patents of addition,
restorations, extensions, supplementary protection certificates, registration or
confirmation patents, patents resulting from post-grant proceedings, re-issues
and re-examinations; (d) other patents or patent applications claiming priority
directly or indirectly to (i) any such specified patent or patent application
specified in (a) through (c), or (ii) any patent or patent application from
which a patent or patent application specified in (a) through (c) claim direct
or indirect priority; (e) inventor’s certificates; and (f) other rights issued
from a Governmental Authority similar to any of the foregoing; in each case of
(a) through (f), irrespective of whether such patent, patent application or
other right arises in the U.S. or any other country or jurisdiction.

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

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[***] 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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1.95“Phase 1 Trial” means a clinical trial of a pharmaceutical product that (a)
(i) is a first-in-humans trial on subjects who are patients, (ii) is for the
purposes of establishing initial safety, tolerability, pharmacokinetic and
pharmacodynamic data for such product, (iii) exposes subjects to such product
and (iv) is designed to provide the sponsor of the clinical trial with
sufficient data about such product to initiate a Phase 2 Trial; or (b) meets the
definition in 21 C.F.R. §312.21(a) or any of its foreign equivalents. 

1.96“Phase 2 Trial” means a clinical trial of a pharmaceutical product (a) with
the endpoint of evaluating its effectiveness for a particular indication or
indications, its short term tolerance and safety, as well as its pharmacokinetic
and pharmacodynamic data in patients with the indications under study and is not
intended to be pivotal to support Marketing Approval for such product; or (b)
that meets the definition in 21 C.F.R. §312.21(b) or any of its foreign
equivalents.

1.97“Phase 2/3 Trial” means a Phase 2 Trial involving a sufficient number of
subjects that, prior to commencement of the trial or at any other defined point
in the trial, satisfies both of the following ((a) and (b)):

(a)        such trial is designed to (i) establish that the applicable
pharmaceutical product is safe and efficacious for its intended use, and (ii)
define and determine warnings, precautions, and adverse reactions that are
associated with the pharmaceutical product in the dosage range to be prescribed,
which trial is intended to support Marketing Approval for such Product or a
similar clinical study prescribed by the FDA; and

(b)        such trial is or becomes a registration trial sufficient for filing
an application for a Marketing Approval the applicable pharmaceutical product in
the U.S., as evidenced by (i) an agreement with or statement from the FDA on a
Special Protocol Assessment or equivalent, or (ii) other guidance or minutes
issued by the FDA, for such registration trial.

1.98“Phase 3 Trial” means a clinical trial of a pharmaceutical product (a) on a
sufficient number of patients, which trial (i) is designed to establish that
such product is safe and efficacious for its intended use, (ii) is designed to
define warnings, precautions and adverse reactions that are associated with such
product in the dosage range to be prescribed, and (iii) is pivotal to support
Marketing Approval for such product; or (b) that meets the definition in 21
C.F.R. §312.21(c) or any of its foreign equivalents.

1.99“Phase 4 Trial” means a clinical trial of a pharmaceutical product, possibly
including pharmacokinetic studies, which trial (a) is not required to be
completed prior to obtaining Marketing Approval for an indication; and (b)
either (i) is required by the applicable Regulatory Authority as mandatory to be
conducted on or after the Marketing Approval of an indication, or (ii) is
conducted voluntarily to enhance scientific knowledge of such product (e.g.,
providing additional drug profile, safety data or marketing support information,
or supporting expansion of product labeling).

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[***] 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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1.100“Product” means any pharmaceutical product, including all forms,
presentations, strengths, doses and formulations (including any method of
delivery), containing a Compound alone or in combination with other APIs.  For
the sake of clarity, all forms, presentations, doses and formulations of a
pharmaceutical product containing a Compound shall be considered the same
Product for purposes of this Agreement, so long as each form, presentation, dose
and formulation contains the same Compound and same other APIs (and no other
Compounds or other APIs).

1.101“Regulatory Approval” means any and all approvals, licenses (including
import licenses), registrations or authorizations from any Regulatory Authority
that are required under Applicable Law or reasonably necessary to Exploit a
pharmaceutical product in any country or jurisdiction for one or more uses, and
all amendments and supplements thereto. 

1.102“Regulatory Authority” means any applicable Governmental Authority with
authority over the Exploitation of a pharmaceutical product in a country or
jurisdiction, including (a) in the U.S., the FDA; and (b) in the European Union,
the EMA and the European Commission.

1.103“Regulatory Documentation” means, with respect to the Compounds and
Products, (a) all applications for Regulatory Approval of any Compound or
Product, including Drug Approval Applications; (b) all Regulatory Approvals for
any Compound or Product, including INDs and Marketing Approvals; (c) all
supporting documents created for, referenced in, submitted to or received from
an applicable Regulatory Authority relating to any of the applications or
Regulatory Approvals described in clauses (a) or (b), including DMF Equivalents,
annual reports, advertising and promotion documents required to be submitted to
Regulatory Authorities, adverse event files, complaint files and Manufacturing
records; (d) all correspondence made to, made with, or received from any
Regulatory Authority (including written correspondence and minutes from
meetings, discussions or conferences) relating to any of the foregoing
applications, Regulatory Approvals or documents described in clauses (a), (b) or
(c), in each case ((a), (b), (c) and (d)), including all Know-How included
therein.

1.104“Right of Reference” shall have the meaning set forth in 21
C.F.R. §314.3(b) or equivalents thereto under Applicable Law in countries or
jurisdictions outside the U.S.

1.105“Royalty Term” means, on a Product-by-Product and country-by-country basis,
the time period beginning with the First Commercial Sale of such Product in such
country (or, if earlier with respect to a Prostate-Approved Single Agent
Product, the first sale or other transfer of such Product in such country for a
use described in clause (B) or (C) of the definition of “Prostate-Approved
Single Agent Product” where such sale or transfer results in a Net Sale) and
continuing until the later of:  (a) the expiration of the last Valid Claim of a
TESARO Patent that Covers such Product in such country; or (b) ten (10) years
from the First Commercial Sale of such Product in such country.

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[***] 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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1.106“Single Agent Product” means (a) any Product that contains a Compound as
its sole API and (b) any Product that is deemed to be a Single Agent Product
pursuant to Section 3.1(e). 

1.107“Supplemental Application” means, with respect to any pharmaceutical
product for which a Drug Approval Application has been approved by the
applicable Regulatory Authority, an application to supplement or amend such Drug
Approval Application to expand the approved label for such pharmaceutical
product to include use of such pharmaceutical product for an additional
indication. 

1.108“Tax” or “Taxes” means any taxes, levies, imposts, duties, charges,
assessments or fees of any nature (including any interest thereon).

1.109“Technology Transfer Costs” means internal and external costs incurred by
TESARO for the transfer of copies of all tangible embodiments of Know-How
necessary for Company’s establishment of Manufacturing capabilities for Compound
API as described in the API Supply Agreement.  With respect to internal costs,
FTEs will be invoiced at an annual rate of $[***]  per FTE (i.e., an hourly rate
of $[***] per FTE, assuming [***] working days per year and an 8 hour
workday).  For the avoidance of doubt, Technology Transfer Costs exclude
expenses for travel and time spent in general planning meetings.  A quarterly
budget for TESARO consulting services related to technology transfer will be
established and agreed to by the Parties in accordance with the API Supply
Agreement.  All Technology Transfer Costs will be invoiced according to Section
8.13.

1.110“Territory” means, (i) with respect to Company and its Affiliates and
(sub)licensees, the Company Territory, and (ii) with respect to TESARO and its
Affiliates and (sub)licensees, the TESARO Territory.  References to a “Party’s
Territory” shall be interpreted accordingly.

1.111“TESARO Calendar Quarter” means the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 and
December 31, for so long as this Agreement is in effect; provided,  however,
that the first TESARO Calendar Quarter for the first TESARO Calendar Year
extends from the Effective Date to the end of the then-current TESARO Calendar
Quarter and the last TESARO Calendar Quarter extends from the first day of such
TESARO Calendar Quarter until the effective date of the termination or
expiration of this Agreement. 

1.112“TESARO Calendar Year” means each successive period of twelve (12) months
commencing on January 1 and ending on December 31, for so long as this Agreement
is in effect.  The last TESARO Calendar Year of the Term begins on January 1 for
the year during which termination or expiration of this Agreement will occur,
and the last day of such TESARO Calendar Year will be the effective date of such
termination or expiration.

1.113“TESARO Field” means (a) with respect to Japan, all uses, including the
diagnosis, treatment or prevention of any disease in humans, and (b) with
respect to any country or jurisdiction outside Japan, all uses outside of the
Company Field.   

1.114“TESARO Know-How” means all Know-How Controlled by TESARO during the Term
that is necessary or useful to Exploit the Compounds or Products in the Company
Field in the Company Territory.

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[***] 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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1.115“TESARO License Agreements” means (a) the Merck License Agreement, and (b)
the AstraZeneca License Agreements. 

1.116“TESARO Net Sales” means with respect to any Product, the gross amounts
invoiced and included as current period sales of such Product by TESARO or any
of its Affiliates or (sub)licensees to a Third Party purchaser in an
arm’s-length transaction, less the following customary deductions, to the extent
they are actually taken, paid, accrued or allocated based on good faith
estimates, all determined in accordance with GAAP and internal policies,
consistently applied: 

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

(g)        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. 

1.117“TESARO Patents” means all Patents Controlled by TESARO during the Term
that are necessary or useful to Exploit the Compounds or Products in the Company
Field in the Company Territory.  TESARO Patents include, as of the Effective
Date, those Patents set forth in Exhibit 1.117, the Merck Patents and
AstraZeneca Patents.    

1.118“TESARO Technology” means, collectively, the TESARO Patents and the TESARO
Know-How.

1.119“TESARO Territory” means worldwide.

1.120“Third Party” means any Person other than (a) Company, (b) TESARO or (c) an
Affiliate of either of Company or TESARO.

1.121“Third Party Royalties” means royalties required to be paid by TESARO or
its Affiliates on Product sales to Third Parties. 

1.122“Trademark” means any word, name, symbol, colour, designation, slogan,
catch phrase or device or any combination thereof used or intended to be used in
commerce and indicating the

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[***] 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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source for a product or service, including any domain name, trademark, trade
dress, brand mark, trade name, brand name, logo or business symbol, any
registrations of any of the foregoing or any pending applications therefor.

1.123“U.S.” means the United States of America, including its territories and
possessions.

1.124“Valid Claim” means either: (a) a claim of an issued and unexpired Patent,
to the extent such claim has not been revoked, held invalid or unenforceable by
a patent office, court or other Governmental Authority of competent jurisdiction
in a final order, from which no further appeal can be taken, and which claim has
not been disclaimed, denied or admitted to be invalid or unenforceable through
reissue, re-examination or disclaimer or otherwise; or (b) a claim of a patent
application that has not been pending for more than seven (7) years from the
date of its first priority patent application filing anywhere in the world and
that has not been revoked, cancelled, withdrawn, held invalid or abandoned. 

Additional Definitions.  Each of the following definitions is set forth in the
Section of this Agreement indicated below:

 

Definition

Section

[***]

[***]

Agreement

Preamble

Alliance Payments

8.3(a)

Alliance Payments Report

Exhibit 8.3

Annual Alliance Payment Forecast

8.3(e)

Annual Royalty Payment Forecast

8.4(c)

API

1.19

API Supply Agreement

7.3(b)

[***]

[***]

AstraZeneca-ICR License Agreement

1.8

AstraZeneca-Sheffield License Agreement

1.8

Bankruptcy Laws

12.7(b)

Blocking Intellectual Property

8.9(b)

Breaching Party

12.4(a)

Clinical Supply Agreement

7.1(a)(ii)

Company

Preamble

Company Combination Product Net Sales

8.4(a)(iii)

Company Development Plan

4.2(c)

Company Field License Agreement

8.9(b)(i)

Company Indemnitee

14.2

Company Infringement Proceeding

14.1(h)

Company Product Liability Proceeding

14.1(g)

Company Prostate-Approved Single Agent Product Net Sales

8.4(a)(ii)

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[***] 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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Definition

Section

Combined Worldwide Prostate-Approved Single Agent Product Net Sales

8.4(a)(i)

Company Combination Product Net Sales

8.4(a)(ii)

Company Prostate-Approved Single Agent Product Net Sales

8.4(a)(iii)

Company Registration Plan

5.2(c)

Company Regulatory Documentation

5.6(b)

Company Trademarks

6.5(a)

[***]

[***]

[***]

[***]

Compound API

7.3(a)

CPR Rules

13.3

Cross-Indication License Agreement

8.9(b)(iii)

Cure Period

12.4(a)

Deadlocked Committee Matter

2.1(d)

Defending Party

14.3(d)

Development Milestone

8.2(a)

Development Milestone Payment

8.2(a)

Development Plans

4.2(c)

Disclosing Party

11.1(a)

Dispute(s)

13.1

[***]

[***]

Equitable Exceptions

10.1(b)

Escalation Procedures

2.1(d)(i)

Effective Date

Preamble

FATCA

8.10(a)

First Prostate Use

Exhibit 8.3

Good Faith Dispute

9.4

ICH

1.57

Incremental Tax Cost

8.10(d)

Indemnification Notice

14.3(a)

Indemnifying Party

14.3(a)

Indemnitee

14.3(a)

Infringement Claim

9.6(a)

Infringement Recovery

9.5(c)

Insolvency Event

12.7(a)

Insolvent Party

12.7(b)

Joint Committee

2.6(a)

Joint Inventions

9.1

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[***] 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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Definition

Section

Joint Patents

9.3(e)

JCC

2.3(a)

JDC

2.2(a)

JFC

2.5(a)

JMC

2.4

JSC

2.1(a)

Licensed Patents

10.2(b)

Losses

14.1

Merck Milestone

8.2(d)

Merck Milestone Payment

8.2(d)

[***]

[***]

Milestone Events

8.2

Milestone Payments

8.2

Monotherapy Registration & Distribution Notice

5.3(b)(iii)

[***]

[***]

Non-Insolvent Party

12.7(b)

Non-Paying Party

8.10(d)

Notice Indication

4.3(b)

Objection

4.2(d)(iii)

Officials

10.5(b)

Other Included Countries

Exhibit 8.3

Party/Parties

Preamble

Pass-through AstraZeneca-ICR Royalty

8.4(b)(i)(2)

Pass-through AstraZeneca-Sheffield Royalty

8.4(b)(i)(2)

Pass-through Merck Royalty

8.4(b)(i)(1)

Patent Extension(s)

9.4

Paying Party

8.10(d)

Payment

10.5(b)

[***]

[***]

Potential Recall Notice

5.9(a)

Pricing Terms

6.2(d)(i)

Prior CDA

1.32

Proceeding

14.1

[***]

[***]

[***]

[***]

[***]

[***]

Promotional Materials

6.8

Prostate-Approved Single Agent Product

8.4(a)(iv)

Prostate-Approved Single Agent Product Net Sales

8.4(a)(v)

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[***] 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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Definition

Section

Prostate Sales Allocation Factor

Exhibit 8.3

Protocol

13.3(b)(iii)

PVA

5.7(c)

Receiving Party

11.1(a)

Redactable Information

4.2(f)(ii)

Related Indemnitees

14.3(a)

Registration Plans

5.2(c)

Regulatory Milestone

8.2(b)

Regulatory Milestone Payment

8.2(b)

Residual Allocation Methodology

Exhibit 8.3

Residual Prostate Sales Allocation Factor

Exhibit 8.3

Reverted Single Agent Product

12.9(a)(ii)

Reviewing Party

4.2(d)(i)

[***]

[***]

[***]

[***]

Royalty Payment Report

8.7

Royalty Tier

8.4(a)(i)

Sales Milestone

8.2(c)

Sales Milestone Payment

8.2(c)

[***]

[***]

Shared Third Party Obligations

8.9(e)

Single Agent Agreement

12.9(a)(vi)

Single Agent Regulatory Approval

12.9(a)(iii)

Single Agent Technology

12.9(a)(ii)

Sole Inventions

9.1

[***]

[***]

[***]

[***]

Term

12.1

Terminating Party

12.4(a)

Termination Effective Date

12.9

Termination Notice Date

12.9

Territory-Wide Company Combination Product Net Sales

8.4(a)(vi)

Territory-Wide Prostate Net Sales

8.4(a)

TESARO

Preamble

TESARO Development Plan

4.2(c)

TESARO Field License Agreement

8.9(b)(ii)

TESARO Incremental Royalty

8.4(b)(ii)

TESARO Indemnitee

14.1

TESARO Infringement Proceeding

14.2(h)

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[***] 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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Definition

Section

TESARO Prostate-Approved Single Agent Product Net Sales

8.4(a)(viii)

TESARO Registration Plan

5.2(c)

TESARO Regulatory Documentation

5.6(a)

TESARO Trademarks

6.5(b)

Third Party Development Report

4.2(h)

Third Party Patent Challenge

9.7(b)

[***]

[***]

[***]

[***]

 

ARTICLE 2

GOVERNANCE

2.1Joint Steering Committee.    

(a)        Formation and Purpose.    The Parties agree to establish and convene
a joint steering committee (the “JSC”) within ninety (90) days after the
Effective Date.  The JSC shall consist of representatives from each Party as
further described in Section 2.6(a) and operate in accordance with this Section
2.1 and Section 2.6. The purpose of the JSC shall be to serve as a forum for
discussing, monitoring and sharing information with respect to the Parties’
Exploitation of the Compounds and Products in the Company Field in the Company
Territory and in the TESARO Field in the TESARO Territory, and to resolve any
Deadlocked Committee Matter pursuant to Section 2.1(d).  Notwithstanding the
foregoing or anything else contained herein to the contrary, Exploitation of the
Compounds or Products by or on behalf of TESARO, in each case, (i) for
Combination Products, Co-Packaged Products or Combination Use in the TESARO
Field in the TESARO Territory or (ii) in Japan, shall not be subject to the
oversight or authority of the JSC or any other Joint Committee; provided, that
the foregoing shall not limit the provisions of ARTICLE 7 with respect to the
allocation of Single Agent Products or Compound API in the event of an
anticipated or actual shortage or any provisions of this Agreement expressly
requiring TESARO to provide to a Joint Committee or Company any reports, plans
or other information regarding Exploitation of Compounds or Products by or on
behalf of TESARO, except to the extent Combination Products, Co-Packaged
Products or Combination Use in the TESARO Field are expressly excluded from such
provisions.

(b)        Responsibilities of the JSC.    The JSC shall: 

(i)discuss and monitor Development, regulatory, Manufacturing, medical affairs
and Commercialization activities with respect to the Compounds

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[***] 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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and Products in the Company Field in the Company Territory and in the TESARO
Field in the TESARO Territory consistent with this Agreement;

(ii)review summaries of results and progress of the Development under the TESARO
Development Plan and Company Development Plan presented or submitted by the
Parties in accordance with Section 4.2(h), including periodic reviews of data,
results and analyses from the Development activities conducted under the TESARO
Development Plan or Company Development Plan (including clinical, regulatory and
safety data, results, reports and analyses);

(iii)establish working groups or committees as necessary or appropriate and
agreed to by the JSC, and delegate tasks within its authority to further discuss
and share information with respect to the Development and Commercialization of
the Compounds and Products in the Company Field in the Company Territory and in
the TESARO Field in the TESARO Territory;

(iv)resolve Deadlocked Committee Matters to the extent authorized by Section
2.1(d); and

(v)perform other obligations specifically delegated to it and permitted under
this Agreement.

(c)JSC Decisions and Actions.  The JSC shall not have any formal decision-making
authority, except with respect to the resolution of Deadlocked Committee Matters
as described in Section 2.1(d).  Actions to be taken and decisions to be made by
the JSC with respect to such matters shall be taken or made by unanimous
agreement, with each Party’s JSC representatives collectively having one (1)
vote. 

(d)Escalation Procedures for Deadlocked Committee Matters.  Either Party may
refer a matter that is expressly designated in Section 2.2(c), 2.3(c), 2.5(c),
7.4(c) or 7.7 as a “Deadlocked Committee Matter” to the JSC for attempted
resolution.  For clarity, no matter, dispute or failure of a Joint Committee to
reach unanimous agreement with respect to any matter, other than those expressly
designated as Deadlocked Committee Matters in the foregoing Sections shall be
subject to the Escalation Procedures or resolution as a Deadlocked Committee
Matter hereunder.  If the JSC does not reach unanimous agreement on any
Deadlocked Committee Matter within thirty (30) Business Days from the date that
the matter is first presented to the JSC, such matter shall be resolved as
follows, which shall be the exclusive mechanism for resolving Deadlocked
Committee Matters:

(i)Either Party may, by written notice to the other, have such Deadlocked
Committee Matter referred to the Executive Officers for resolution.  The
Executive Officers shall meet promptly to discuss such Deadlocked

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[***] 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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Committee Matter and seek in good faith to determine a resolution.  If the
Executive Officers do not agree upon a resolution in a timely manner, which
shall in no case be more than thirty (30) calendar days after the Deadlocked
Committee Matter was referred to them, then such Deadlocked Committee Matter
shall be resolved in accordance with Section 2.1(d)(ii) and the relevant
provision of this Agreement pursuant to which such Deadlocked Committee Matter
was referred to the JSC.  The procedures set forth in this Section 2.1(d)(i) are
referred to as the “Escalation Procedures.”

(ii)If another provision of this Agreement expressly designates a matter as a
Deadlocked Committee Matter and provides: (A) for a resolution methodology or a
specific final resolution with respect to such Deadlocked Committee Matter in
the event mutual agreement is not reached other than final decision-making
authority of a Party (e.g., resolution by an independent Third Party accountant,
or the status quo prevails), then such resolution methodology or specific final
resolution shall be binding on the Parties; or (B) that one of the Parties has
final decision-making authority with respect to such Deadlocked Committee Matter
in the event mutual agreement is not reached, then the decision of the Party
with final decision-making authority on such matter shall be final and binding
on the Parties subject to the limitations set forth in Section 2.1(d)(iii). 

(iii)Notwithstanding anything to the contrary in this Agreement, neither Party
may exercise its final decision-making authority with respect to a Deadlocked
Committee Matter to: (1) amend this Agreement or a Party’s rights or obligations
under this Agreement; (2) determine that either Party has fulfilled or breached
a Party’s obligations under this Agreement; (3) make any decision that expressly
requires TESARO’s or Company’s approval or agreement or the approval or
agreement of both Parties under this Agreement; (4) resolve any dispute
regarding whether a Milestone Event has been achieved, the amount of any
royalties or other payments owed by one Party to the other Party, or the Net
Sales of a Product allocable to an Indication; (5) resolve any dispute regarding
whether a matter is a Deadlocked Committee Matter or subject to TESARO or
Company final decision-making under this Agreement, or whether a matter is a
Dispute hereunder; (6) cause either Party to violate Applicable Law or
regulatory requirements; or (7) cause the other Party to violate or not be in
compliance with its own health care compliance policies and procedures of
general application, consistently applied by such Party and its Affiliates, or
any corporate integrity agreement to which such Party is subject.

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[***] 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)Except as expressly provided in this Agreement with respect to the
Deadlocked Committee Matters, no matter, decision, or action of the Parties
shall require the agreement, approval or consent of a Joint Committee. 

(v)If another provision of this Agreement expressly provides for the Parties to
engage a Third Party accounting firm to resolve a Deadlocked Committee Matter,
the following terms shall apply:

(1)        The Parties shall mutually select and engage an independent Third
Party accounting firm that has no auditing or other financial relationship with
either Party or any of its Affiliates.

(2)        Such accounting firm shall, as soon as reasonably practicable after
such firm is engaged, deliver a report to each Party with its analysis and
determination of such Deadlocked Committee Matter. 

(3)        The costs of such firm’s services shall be shared equally by the
Parties (for clarity, subject to Section 8.11 in the event of any audit
conducted thereunder).

(e)General Performance.  If either Party reasonably believes that the other
Party intends to take any action relating to any Compound or Product that would
reasonably be expected to materially and adversely affect such Party’s
Development or Commercialization of the Compounds or Products in its Field in
its Territory, then such Party may so notify the other Party; provided,
 however, that this Section 2.1(e) shall not apply with respect to any
Deadlocked Committee Matter or any matter that a Joint Committee is expressly
authorized to determine, approve or resolve under this Agreement.  If a Party
receives a notice pursuant to this Section 2.1(e) and it has not yet taken the
action identified therein, such Party shall use commercially reasonable efforts
to refrain from taking such action until the Parties have attempted to resolve
the notifying Party’s concerns in accordance with this Section 2.1(e).  The
Parties shall meet promptly thereafter (and, in any event, within ten (10)
Business Days thereafter) to discuss the concerns raised in such notice and
shall use good faith efforts to agree upon a mutually acceptable resolution to
such concerns within thirty (30) calendar days after receipt of the notice.  If
the Parties do not agree upon a resolution within such thirty (30) day period,
either Party may, by written notice to the other, have the matter referred to
the Executive Officers for resolution.  The Executive Officers shall meet
promptly to discuss such matter and to seek in good faith to determine a
mutually acceptable resolution.  If the Executive Officers do not agree upon a
resolution in a timely manner, which shall in no case be more than ten (10)
calendar days after the matter was referred to them, then the final decision
regarding the taking, or refraining from taking, the applicable action will be
made by the Party proposing

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[***] 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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to take such action, or, if either Party has the sole right under this Agreement
to take such action, the Party with the sole right to take the action.  For the
avoidance of doubt, if a Party has the right to take an action under this
Agreement, it shall not be a breach of this Agreement if such Party takes such
action prior to the conclusion of the process contemplated by this Section
2.1(e); provided, that (i) it is reasonably necessary for such Party to take
such action, and (ii) such Party sought in good faith to reach mutual agreement
on the matter. 

2.2Joint Development Committee.    

(a)Formation and Purpose.    The Parties agree to establish and convene a joint
development committee (the “JDC”) within ninety (90) days after the Effective
Date.  The JDC shall consist of representatives from each Party as further
described in Section 2.6(a) and operate in accordance with this Section 2.2 and
Section 2.6. The purpose of the JDC shall be to serve as a forum for discussing,
monitoring and sharing information with respect to the Parties’ Development of,
and regulatory activities related to, the Compounds and Products in the Company
Field in the Company Territory and in the TESARO Field in the TESARO Territory,
and to determine, approve or resolve matters with respect to such Development
and regulatory activities that the JDC is expressly authorized under Section
2.2(c) to determine, approve or resolve under this Agreement.

(b)Responsibilities of the JDC.    The JDC shall: 

(i)discuss and monitor Development and regulatory activities with respect to the
Compounds and Products in the Company Field in the Company Territory and in the
TESARO Field in the TESARO Territory;

(ii)review and discuss the Development Plans submitted by the Parties in
accordance with Section 4.2(c), and discuss any concerns raised by either Party
with respect to such Development Plans in accordance with Section 4.2(c);

(iii)discuss any Objection with respect to a Clinical Trial that is referred to
the JDC pursuant to Section 4.2(d);

(iv)discuss the logistics of sharing Know-How pursuant to Section 4.2(f) and
sharing safety data and Regulatory Documentation pursuant to Section 5.5;

(v)to the extent requested by a Party pursuant to Section 4.2(f), discuss issues
related to the Development of the Compounds or Products;

(vi)review summaries of results and progress of the Development under the TESARO
Development Plan and Company Development Plan, including

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[***] 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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periodic reviews of data, results and analyses from the Development activities
conducted pursuant under the TESARO Development Plan or Company Development Plan
(including clinical, regulatory and safety data, results, reports and analyses)
provided by the Parties pursuant to Section 4.2(h);

(vii)review and discuss the Registration Plans submitted by the Parties in
accordance with Section 5.2(c), and discuss any concerns raised by either Party
with respect to the Registration Plans in accordance with Section 5.2(c);

(viii)review and discuss the Parties’ medical affairs plans with respect to the
Products in the Company Field in the Company Territory and in the TESARO Field
in the TESARO Territory (e.g. field-based medical education activities and
grant-based medical education programs) in accordance with Section 5.8;

(ix)discuss any Phase 4 Trials of the Products;

(x)consult with the Joint Manufacturing Committee with respect to clinical
supply manufacturing in accordance with Section 7.4(b);

(xi)discuss a publication strategy with respect to the Compounds and Products
and the review of such publications, in accordance with Section 11.9;

(xii)establish working groups or committees as necessary or appropriate and
agreed to by the JDC, and delegate tasks within its authority to further discuss
and share information with respect to the Development of the Compounds and
Products in the Company Field in the Company Territory and in the TESARO Field
in the TESARO Territory, such as a quality subcommittee and separate clinical
quality subcommittees for purposes of overseeing the conduct of Clinical Trials
in accordance with GLP, GCP and the PVA; and

(xiii)perform other obligations specifically delegated to it and permitted under
Section 2.2(c) or another provision of this Agreement.

(c)JDC Decisions and Actions.  The JDC shall not have any formal decision-making
authority, except with respect to the following matters: 

(i)The JDC shall determine whether any Drug Approval Application for a
Monotherapy Use in the Company Field submitted by Company to the JDC in
accordance with Section 5.3(b)(iv)  satisfies the appropriate efficacy and
safety criteria outlined in the applicable protocol and notify Company of the
results of such review.  If the JDC does not reach unanimous agreement

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[***] 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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on such matter within thirty (30) Business Days from the date that the matter is
first presented to the JDC, such matter will be a Deadlocked Committee
Matter.  Either Party may refer such matter to the JSC for attempted resolution
pursuant to the Escalation Procedures.  If the matter is not resolved pursuant
to the Escalation Procedures, TESARO shall have final decision-making authority
with respect to such Deadlocked Committee Matter.

(ii)The JDC shall determine which portions of a Drug Approval Application for
Combination Use or a Combination Product, in each case, in the Company Field in
the Company Territory are subject to review and comment by the Parties pursuant
to Sections 5.3(c)(iii) and 5.3(d)(iii).  If the JDC does not reach unanimous
agreement on such matter within thirty (30) Business Days from the date that the
matter is first presented to the JDC, such matter will be a Deadlocked Committee
Matter.   Either Party may refer such matter to the JSC for attempted resolution
pursuant to the Escalation Procedures.  If the matter is not resolved pursuant
to the Escalation Procedures, the Party submitting such Drug Approval
Application shall have final decision-making authority with respect to such
Deadlocked Committee Matter.  For clarity, this Section 2.2(c)(ii) does not
apply to Combination Use or Combination Products in the TESARO Field in the
TESARO Territory.

Actions to be taken and decisions to be made by the JDC with respect to such
matters shall be taken or made by unanimous agreement, with each Party’s JDC
representatives collectively having one (1) vote.  If the JDC does not reach
unanimous agreement on an action or decision with respect to any Deadlocked
Committee Matter within thirty (30) Business Days from the date that the matter
is first presented to the JDC, such Deadlocked Committee Matter shall be
referred to the JSC or otherwise subject to resolution in accordance with
Section 2.1(d).

2.3Joint Commercialization Committee.    

(a)Formation and Purpose.    The Parties agree to establish and convene a joint
commercialization committee (the “JCC”) within ninety (90) days after the
Effective Date.  The JCC shall consist of representatives from each Party as
further described in Section 2.6(a) and operate in accordance with this Section
2.3 and Section 2.6. The purpose of the JCC shall be to serve as a forum for
discussing, monitoring and sharing information with respect to the Parties’
Commercialization of the Compounds and Products in the Company Field in the
Company Territory and in the TESARO Field in the TESARO Territory, to seek
alignment between the Parties with respect to certain aspects of such
Commercialization and to determine, approve or resolve matters with respect to

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[***] 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 Commercialization that the JCC is expressly authorized under Section 2.3(c)
to determine, approve or resolve under this Agreement.

(b)Responsibilities of the JCC.    The JCC shall: 

(i)discuss and monitor the Commercialization of the Products in the Company
Field in the Company Territory and in the TESARO Field in the TESARO Territory,
including promotional activities with respect thereto, to the extent permissible
under Applicable Law;

(ii)discuss and seek to reach alignment with respect to key aspects of the
Distribution of Single Agent Products in accordance with Section 6.2(c)(i);

(iii)review and discuss Pricing Terms with respect to the Products to the extent
provided under Section 6.2(d);

(iv)review and discuss the commercialization plans submitted by the Parties, and
seek to reach alignment on key Commercialization issues relating to the
Products, in accordance with Section 6.2(e);

(v)discuss and seek to reach alignment with respect to recommendations of the
JFC on certain matters as described in Exhibit 8.3, or in the event the JFC
fails to reach unanimous agreement with respect to any such matters;  and

(vi)perform other obligations specifically delegated to it and permitted under
Section 2.3(c) or another provision of this Agreement.

(c)JCC Decisions and Actions.  The JCC shall not have any formal decision-making
authority, except with respect to the following matters:

(i)The JCC shall determine procedures for TESARO’s regulatory compliance review
and approval of Company’s Promotional Materials in accordance with Section
6.8.  If the JCC does not reach unanimous agreement on such matter within thirty
(30) Business Days from the date that the matter is first presented to the JCC,
such matter will be a Deadlocked Committee Matter.  Either Party may refer such
matter to the JSC for attempted resolution pursuant to the Escalation
Procedures.  If the matter is not resolved pursuant to the Escalation
Procedures, TESARO shall have final decision-making authority with respect to
such Deadlocked Committee Matter.

(ii)The JCC shall approve a Major Market Net Sales Allocation Methodology and
Residual Allocation Methodologies based on recommendations from

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[***] 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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the JFC in accordance with Exhibit 8.3.  If the JCC does not reach unanimous
agreement on such matter within thirty (30) Business Days from the date that the
matter is first presented to the JCC, such matter will be a Deadlocked Committee
Matter.   Either Party may refer such matter to the JSC for attempted resolution
pursuant to the Escalation Procedures.  If the matter is not resolved pursuant
to the Escalation Procedures, the Parties shall mutually select and engage an
independent Third Party accounting firm to resolve such Deadlocked Committee
Matter pursuant to Section 2.1(d)(v).

(iii)The JCC shall determine which countries outside the Major Markets will be
included as Other Included Countries in accordance with Exhibit 8.3.  If the JCC
does not reach unanimous agreement on such matter within thirty (30) Business
Days from the date that the matter is first presented to the JCC, such matter
will be a Deadlocked Committee Matter.  Either Party may refer such matter to
the JSC for attempted resolution pursuant to the Escalation Procedures.  If the
matter is not resolved pursuant to the Escalation Procedures, the proposed
change to the list of Other Included Countries will not be made.

(iv)The JCC shall reassess the Major Market Net Sales Allocation Methodology and
its data sources on an annual basis, and approve required changes to such
methodology, in accordance with Exhibit 8.3.  If the JCC does not reach
unanimous agreement on such matter within thirty (30) Business Days from the
date that the matter is first presented to the JCC, such matter will be a
Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for
attempted resolution pursuant to the Escalation Procedures.  If the matter is
not resolved pursuant to the Escalation Procedures, [***].

(v)The JCC shall reassess the use of the Major Market Net Sales Allocation
Methodology in the Other Included Countries on an annual basis, and determine
whether additional countries should be included as Other Included Countries, in
accordance with Exhibit 8.3.  If the JCC does not reach unanimous agreement on
such matter within thirty (30) Business Days from the date that the matter is
first presented to the JCC, such matter will be a Deadlocked Committee
Matter.  Either Party may refer such matter to the JSC for attempted resolution
pursuant to the Escalation Procedures.  If the matter is not resolved pursuant
to the Escalation Procedures, no change will be made to such use or list of
Other Included Countries for such year.

(vi)The JCC shall determine the Distribution costs and prostate
commercialization and other related costs incurred by TESARO to be

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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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deducted from TESARO Prostate-Approved Single Agent Product Net Sales for
purposes of calculating Alliance Payments pursuant to Exhibit 8.3.  If the JCC
does not reach unanimous agreement on such matter within thirty (30) Business
Days from the date that the matter is first presented to the JCC, such matter
will be a Deadlocked Committee Matter.  Either Party may refer such matter to
the JSC for attempted resolution pursuant to the Escalation Procedures.  If the
matter is not resolved pursuant to the Escalation Procedures, the Parties shall
mutually select and engage an independent Third Party accounting firm to resolve
such Deadlocked Committee Matter pursuant to Section 2.1(d)(v).

Actions to be taken and decisions to be made by the JCC with respect to such
matters shall be taken or made by unanimous agreement, with each Party’s JCC
representatives collectively having one (1) vote.  If the JCC does not reach
unanimous agreement on a Deadlocked Committee Matter within thirty (30) Business
Days from the date that the matter is first presented to the JCC, such
Deadlocked Committee Matter shall be referred to the JSC or otherwise subject to
resolution in accordance with Section 2.1(d).

2.4Joint Manufacturing Committee.  The Parties shall establish a joint
manufacturing and supply chain committee (the “JMC”) in accordance with Section
7.4.    

2.5Joint Finance Committee.

(a)Formation and Purpose.    The Parties agree to establish and convene a joint
finance committee (the “JFC”) within ninety (90) days after the Effective
Date.  The JFC shall consist of individuals from each Party with reasonable
expertise in the areas of accounting, cost allocation, budgeting and financial
reporting as further described in Section 2.6(a) and operate in accordance with
this Section 2.5 and Section 2.6.  The JFC shall be a forum for discussing,
monitoring, sharing information and seeking to reach alignment regarding the
conduct of the accounting, reporting, reconciliation and other related finance
and accounting activities set forth in this Agreement, and to determine, approve
or resolve matters with respect to such finance and accounting activities that
the JFC is expressly authorized under Section 2.5(c) to determine, approve or
resolve under this Agreement.

(b)Responsibilities of the JFC.    The JFC shall:

(i)discuss and seek to make unanimous recommendations to the JCC on certain
matters as described in Exhibit 8.3;

(ii)if the Major Market Net Sales Allocation Methodology, Residual Allocation
Methodology, list of Other Included Countries or any other decision described in
Exhibit 8.3 is not resolved prior to launch of a

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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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Prostate-Approved Single Agent Product in a particular country, develop and seek
to agree upon an interim methodology to allow each Party to appropriately record
and report its financial position and contributions as necessary at quarter or
year-end with respect to sales of such Prostate-Approved Single Agent Product in
such country in accordance with Exhibit8.3;

(iii)upon the request of either Party, review and discuss the allocation of
rebates payable to federal, state/provincial, local or other governments, or
their agencies, with respect to sales of a Prostate-Approved Single Agent
Product in a country in accordance with Section 3.2 of Exhibit 8.3; and

(iv)perform other obligations specifically delegated to it and permitted under
Section 2.5(c) or another provision of this Agreement.

(c)JFC Decisions and Actions.  The JFC shall not have any formal decision-making
authority, except with respect to the following matters:

(i)The JFC shall develop and approve procedures for quarterly reporting of
actual results, and review and discussion of potential discrepancies, quarterly
reconciliation, reasonable forecasting, and other finance and accounting matters
in accordance with Section 8.3(b).  If the JFC does not reach unanimous
agreement on any such matter within thirty (30) Business Days from the date that
the matter is first presented to the JFC, such matter will be a Deadlocked
Committee Matter.  Either Party may refer such matter to the JSC for attempted
resolution pursuant to the Escalation Procedures.  If the matter is not resolved
pursuant to the Escalation Procedures, each Party may, in good faith, select its
own reasonable procedures for such reporting not otherwise inconsistent with
this Agreement or applicable Third Party license agreements. 

(ii)The JFC shall determine the timing for delivery of the Annual Alliance
Payment Forecast in accordance with Section 8.3(e).  If the JFC does not reach
unanimous agreement on such determination within thirty (30) Business Days from
the date that the matter is first presented to the JFC, such forecast shall be
delivered by November 1 of each year.

(iii)The JFC shall determine whether any additional information should be
included in the Annual Alliance Payment Forecast in accordance with Section
8.3(e).  If the JFC does not reach unanimous agreement on any such matter within
thirty (30) Business Days from the date that the matter is first presented to
the JFC, such matter will be a Deadlocked Committee Matter.  Either Party may
refer such matter to the JSC for attempted resolution pursuant to the Escalation
Procedures.  If the matter is not resolved pursuant to the Escalation
Procedures, TESARO shall not be required to provide such additional information.

(iv)The JFC shall develop and approve a process for the Parties to agree upon
the estimated Alliance Payments for a TESARO Calendar Quarter before the close
of such TESARO Calendar Quarter in accordance with Section 8.3(e).  If the JFC
does not reach unanimous agreement on such matter within thirty (30) Business
Days from the date that the matter is first presented to the JFC, such matter
will be a Deadlocked Committee Matter.  Either Party may refer such matter to
the JSC for attempted resolution pursuant to the Escalation Procedures.  If the
matter is not

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[***] 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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resolved pursuant to the Escalation Procedures, TESARO shall have final
decision-making authority with respect to such Deadlocked Committee Matter.

(v)The JFC shall determine the timing for delivery of the Annual Royalty Payment
Forecast in accordance with Section 8.4(c).  If the JFC does not reach unanimous
agreement on such determination within thirty (30) Business Days from the date
that the matter is first presented to the JFC, such forecast shall be delivered
by November 1 of the year prior to the year covered by such forecast.

(vi)The JFC shall determine whether any additional information should be
included in the Annual Royalty Payment Forecast in accordance with Section
8.4(c).  If the JFC does not reach unanimous agreement on such matter within
thirty (30) Business Days from the date that the matter is first presented to
the JFC, such matter will be a Deadlocked Committee Matter.  Either Party may
refer such matter to the JSC for attempted resolution pursuant to the Escalation
Procedures.  If the matter is not resolved pursuant to the Escalation
Procedures, neither Party shall be required to provide any such additional
information; provided, that the foregoing shall not limit the Parties express
obligations with respect to the Annual Royalty Payment Forecast under Section
8.4(c).

(vii)The JFC shall review and approve any proposed reallocations and adjustments
of Net Sales of Prostate-Approved Single Agent Products in accordance with
Section 3.3 of Exhibit 8.3.  If the JCC does not reach unanimous agreement on
such matter within thirty (30) Business Days from the date that the matter is
first presented to the JCC, such matter will be a Deadlocked Committee
Matter.   Either Party may refer such matter to the JSC for attempted resolution
pursuant to the Escalation Procedures.  If the matter is not resolved pursuant
to the Escalation Procedures, the Parties shall mutually select and engage an
independent Third Party accounting firm to resolve such Deadlocked Committee
Matter pursuant to Section 2.1(d)(v).  

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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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Actions to be taken and decisions to be made by the JFC shall be taken or made
by unanimous agreement, with each Party’s JFC representatives collectively
having one (1) vote.  If the JFC does not reach unanimous agreement on an action
or decision with respect to any such matter to be recommended to the JCC within
thirty (30) Business Days from the date that the matter is first presented to
the JFC or within the time period otherwise expressly provided in this
Agreement, such action or decision shall be referred to the JCC for its
consideration.  If the JFC does not reach unanimous agreement on a Deadlocked
Committee Matter within thirty (30) Business Days from the date that the matter
is first presented to the JFC, such Deadlocked Committee Matter shall be
referred to the JSC or otherwise subject to resolution in accordance with
Section 2.1(d).

2.6Committee Membership and Operations.    

(a)Membership. Each of the JSC, JDC, JCC, JMC and JFC (each, a “Joint
Committee”) shall consist of up to six (6) representatives, one-half of which
shall be appointed by Company and one-half of which shall be appointed by
TESARO.  Each Joint Committee may elect to vary the number of representatives
from time to time, provided that each Joint Committee shall maintain an equal
number of representatives from each Party.  Each representative shall have the
appropriate level of experience in the subject area of the applicable Joint
Committee, and at least one (1) representative shall have sufficient seniority
within the applicable Party’s organization to have the necessary decision-making
authority in order for such Joint Committee to fulfill its
responsibilities.  Either Party may designate substitutes for its Joint
Committee representatives if one (1) or more of such Party’s designated
representatives is unable to be present at a meeting.  A Party may replace any
of its Joint Committee representatives by written notice to the other Party
specifying the prior representative(s) and their replacement(s).  Each Joint
Committee representative shall be bound by confidentiality and non-use
obligations at least as restrictive as those set forth in this Agreement to, and
shall be an employee of, the Party that it represents or one of such Party’s
Affiliates.

(b)Joint Committee Chairperson.    Each Joint Committee will have a chairperson,
to be designated by Company.  The chairperson shall be responsible for calling
and convening meetings of its Joint Committee (provided, the chairperson shall
call meetings at the reasonable request of TESARO or any of its representatives
in accordance with Section 2.6(c)), but shall have no special authority over the
other members of its Joint Committee.  The chairperson of each Joint Committee
(or its designee) shall: (i) prepare and circulate an agenda reasonably in
advance of each upcoming meeting of such Joint Committee (provided that any
agenda shall be mutually agreed by the committee members); and (ii) prepare and
issue minutes of each meeting of such Joint Committee within thirty (30) days
thereafter.  Each representative on each Joint Committee may, prior to any
meeting, submit to the chairperson materials to be circulated to each member of
the Joint Committee

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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together with the meeting agenda or otherwise.  The minutes for each Joint
Committee meeting shall not be finalized until each representative on such Joint
Committee reviews and approves such minutes, provided that any minutes from a
Joint Committee meeting shall be deemed approved unless a representative on such
Joint Committee objects to the accuracy of such minutes within fifteen (15) days
after circulation by the chairperson of such Joint Committee. 

(c)Meetings. 

(i)Timing and Frequency.  Promptly following its formation, each Joint Committee
will hold an in-person meeting to establish its operating procedures consistent
with this Agreement.  After its initial meeting, the JSC shall meet at least
twice per year during the Term and each other Joint Committee shall meet at
least once every Calendar Quarter during the Term or as frequently as agreed by
the Parties.  Additional meetings of a Joint Committee may be held with the
consent of each Party (such consent not to be unreasonably withheld, delayed or
conditioned), as required under this Agreement or to discuss any Deadlocked
Committee Matter referred to such Joint Committee in accordance with this
Agreement.  In the case of any matter or deadlock referred to a Joint Committee,
such meeting shall be held within ten (10) Business Days following referral to
such Joint Committee, or as soon as reasonably possible thereafter.    

(ii)Meeting Procedures.  Meetings of a Joint Committee shall be effective only
if a majority of representatives on such Joint Committee of each Party are
present or participating, including at least one (1) representative of each
Party.  Other than the initial meeting, each Joint Committee may meet either (x)
in person at either Party’s facilities (alternating between facilities of each
Party unless otherwise agreed) or at such locations as the Parties may otherwise
agree, at least twice every Calendar Year; or (y) by audio or video
teleconference.  Each Party shall be responsible for all of its own expenses
incurred in connection with its representatives’ participation in each Joint
Committee meeting, including all travel and lodging.  All other Third Party
expenses incurred by a Joint Committee for one of its meeting, such as expenses
associated with off-site meetings, shall be shared equally by the Parties.

(iii)Non-Member Participation.  Additional non-members of a Joint Committee
having relevant experience may be invited to participate in a meeting of such
Joint Committee, provided that such participants shall have no voting rights or
powers.  Non-member participants of a Party or its Affiliates shall be allowed
to attend a meeting of a Joint Committee only if: (x) the other Party’s
representatives on such Joint Committee have consented to the attendance (such
consent not to be unreasonably

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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withheld, delayed or conditioned); and (y) such non-member participant is
subject to confidentiality and non-use obligations at least as restrictive as
those set forth in this Agreement. 

2.7Additional Subcommittees.  Each Joint Committee may establish subcommittees
to perform any responsibilities assigned to such Joint Committee under this
Agreement; provided, that no subcommittee shall (a) have any decision-making
authority, or (b) be delegated any matter that is or could become a Deadlocked
Committee Matter.  The purpose, scope and procedures of any such subcommittee
shall be agreed in writing by the Joint Committee that establishes such
subcommittee.  Unless otherwise agreed by the Parties, any such subcommittee
shall consist of an equal number of representatives appointed by Company and
TESARO, or their respective representatives on the applicable Joint Committee,
and the number of representatives on any such subcommittee may be varied from
time to time by the applicable Joint Committee or by mutual agreement of the
Parties, subject to the foregoing. 

2.8Authority.  The Parties agree that it shall be conclusively presumed that,
unless otherwise explicitly stated, each voting member of each Joint Committee
and subcommittee has the authority and approval of such member’s respective
senior management in casting his or her vote.  Each Joint Committee and
subcommittee shall each have only the powers expressly assigned to it in this
ARTICLE 2 or elsewhere in this Agreement, and shall not have any power to amend,
modify or waive compliance with this Agreement.  Notwithstanding anything else
contained herein to the contrary, except as expressly provided in this Agreement
with respect to the Deadlocked Committee Matters, no matter, decision, or action
of the Parties shall require the agreement, approval or consent of a Joint
Committee or any subcommittee thereof. 

2.9Alliance Managers.  Promptly following the Effective Date, each Party shall
designate in writing an Alliance Manager to serve as the primary point of
contact for the Parties regarding all collaboration activities contemplated
under this Agreement.  Each Alliance Manager shall facilitate communication and
coordination of the Parties’ activities under this Agreement relating to the
Compounds and the Products.  The Alliance Managers shall be allowed to attend,
as a non-voting observer, meetings of each Joint Committee and subcommittee of
which the Alliance Manager is not a member.

2.10Compliance with Merger Control Laws.  It is the intent of the Parties to at
all times during the Term comply with applicable Merger Control Laws.  If at any
time during the Term, either Party in good faith reasonably determines upon the
advice of counsel that the performance by either Party of its obligations under
this Agreement or this Article 2, including with respect to the sharing of
information, would violate applicable Merger Control Laws, then the Parties
shall negotiate in good faith to agree upon mutually acceptable alternative
arrangements that comply with applicable Merger Control Laws, including, if
reasonably requested by a Party, arranging for information deliverable to a
Party hereunder to be delivered to a mutually agreed Third Party. 

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[***] 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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ARTICLE 3

LICENSES

3.1Licenses to Company.    

(a)License to Company.  Subject to the terms and conditions of this Agreement,
TESARO hereby grants to Company a royalty-bearing, non-transferable (except to
the extent permitted under Section 15.4) license, with the right to grant
sublicenses as provided in Section 3.1(c), under the TESARO Technology and
TESARO Trademarks, which license shall be non-exclusive with respect to the
Merck Know-How and exclusive (even as to TESARO, except to the extent necessary
for TESARO to perform its obligations under this Agreement, including Sections
5.2(d), 6.2(c) and 6.2(d)) with respect to any TESARO Technology (other than the
Merck Know-How) and the TESARO Trademarks, to Exploit the Compounds and Products
in the Company Field in the Company Territory.  The foregoing license grant by
TESARO does not include any grant of rights under the TESARO Technology or
TESARO Trademarks to Exploit any active pharmaceutical compound that is not a
Compound, other than, to the extent applicable, any API(s) Controlled by TESARO
(if any) that are included in a Product that is deemed to be a Single Agent
Product pursuant to Section 3.1(e).    

(b)Rights under Merck Patents [***].    Notwithstanding the definition of
“Company Field” or anything to the contrary contained herein, Company
acknowledges and agrees that (i) the license granted to TESARO under the Merck
License Agreement does not include the right or license under the Merck Patents
or the Merck Know-How to Exploit the Compounds or Products for the diagnosis of
any indication in humans, and therefore the foregoing license grant by TESARO to
Company hereunder does not include a sublicense under the Merck Patents or the
Merck Know-How to Exploit the Compounds or Products for the diagnosis of any
indication in humans[***].

(c)Sublicensing. Company shall have the right to grant sublicenses of the rights
granted to Company under this Section 3.1 to its Affiliates and Third Parties
through multiple tiers provided that: 

(i)Company has provided at least five (5) Business Days’ prior written notice to
TESARO of any sublicense; provided, that sublicenses granted solely in
connection with Development (but not Commercialization), such as licenses to
contract manufacturers (other than any contract manufacturer engaged by TESARO
or its Affiliates), contract research organizations or clinical study sites,
shall not require any notice to TESARO; and

(ii)each such sublicense shall (1) refer to and be subordinate to this
Agreement, (2) be consistent in all material respects with the terms and
conditions of this Agreement and the TESARO License Agreements, and

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[***] 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) include Section 10.4 and the provisions of the Merck License Agreement set
forth on Exhibit 10.4.

Company shall use reasonable efforts to procure the prompt performance by any
sublicensee of the terms of each such sublicense agreement and ensure that any
sublicensee will comply with the applicable terms and conditions of this
Agreement.  Company shall be liable for all acts and omissions of any
sublicensee and shall indemnify TESARO against all Losses incurred or suffered
by TESARO, or for which TESARO may become liable, arising out of any act or
omission of any sublicensee, pursuant to Section 14.1.  The grant of any
sublicense will not relieve Company of its obligations under this Agreement,
except to the extent such obligations are satisfactorily performed by such
sublicensee.  Notwithstanding Section 3.1(c)(i) above, Company shall provide to
TESARO copies of each sublicense with a Third Party that grants such Third Party
the right to directly Develop or Commercialize the Compounds or Products in the
Company Field in any country or jurisdiction in the Company Territory within
five (5) days after execution thereof; provided that Company shall have the
right to reasonably redact commercially sensitive information from such
copies.  Information regarding the scope of the license grants, territory or
term of each such sublicense and the identity of the Third Party shall not be
considered commercially sensitive. 

(d)Exclusivity.  During the period commencing on the Effective Date and ending
on the [***] anniversary of the Effective Date (the “Exclusivity Period”),
neither TESARO nor any of its Affiliates shall, directly or indirectly: (i)
[***], except to the extent necessary to perform TESARO’s obligations under this
Agreement or the TESARO License Agreements; (ii) [***], except to the extent
necessary to perform TESARO’s obligations under this Agreement; (iii) [***]; or
(iv) collaborate with, license, enable or otherwise authorize or grant any
rights to any Third Party to conduct any of the activities described in clause
(i), (ii) or (iii) of this Section 3.1(d), or enter into any agreement,
amendment to an existing agreement or option to do any of the same; or (v)
[***].  Notwithstanding anything to the contrary herein, the restrictions in
this Section 3.1(d) are subject to the terms of [***]. 

(e)Products containing Non-Cancer APIs.  If either Party or its Affiliates
desires to Develop or Commercialize, directly or indirectly, any Product that
contains a Compound and at least one other API that is not intended to treat
cancer (e.g., [***]) it shall notify the other Party in writing.  If such
Product includes another API intended to treat cancer (e.g., a JAA), such
Product shall be deemed to be a “Combination Product” for purposes of this
Agreement.  If such Product does not include another API intended to treat
cancer, such Product shall be deemed to be a “Single Agent Product” for purposes
of this Agreement.  Following receipt of such notice, the Parties shall
negotiate in good faith and attempt to agree upon an

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[***] 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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adjustment to the calculation of Net Sales of any such Product in the Company
Field, in each case, that fairly reflects the value of the Compound included in
such Product and the other API(s) included in such Product.  If the Parties fail
to reach Agreement on such an adjustment prior to the First Commercial Sale of
any such Product anywhere in the Company Territory, then such Net Sales shall be
calculated in accordance with Section 1.116 or Section 1.25, as applicable;
provided, that such failure may be referred to the dispute resolution process
under ARTICLE 13 as a Dispute hereunder, and the resolution of such Dispute
shall include a retroactive reconciliation back to the date of such First
Commercial Sale, as appropriate.  For the avoidance of doubt, this Section
3.1(e) does not apply to any Combination Product Developed or Commercialized,
directly or indirectly, by TESARO in the TESARO Field or to any Product
Developed or Commercialized, directly or indirectly, by TESARO solely in Japan.

(f)Co-Packaged Products.  Company shall not Exploit any Compound or Product as a
component of any Co-Packaged Product unless and until the Parties amend this
Agreement to set forth (i) terms and conditions applicable to pricing of
Co-Packaged Products and (ii) any other terms and conditions applicable to
Commercialization of Co-Packaged Products that the Parties agree should be
different from the terms and conditions relating to Commercialization of other
Products.  [***]  If Company desires to Exploit any Compound or Product as a
component of Co-Packaged Products in the Company Field and the Company
Territory, then the Parties will negotiate in good faith to execute such
amendment as soon as reasonably practicable.  For the avoidance of doubt,
[***]. 

3.2License to TESARO. 

(a)License to TESARO.  Subject to the terms and conditions of this Agreement,
Company hereby grants to TESARO a non-exclusive, fully-paid, royalty-free,
non-transferable (except in accordance with Section[***]  15.4), license, with
the right to grant sublicenses as provided in Section 3.2(b), under the Company
Technology to Exploit the Compounds and Single Agent Products in the TESARO
Field (but not including prostate cancer in humans) in the Company
Territory.  The foregoing license grant by Company does not include (x) any
grant of rights under the Company Technology to Exploit any active
pharmaceutical compound that is not a Compound other than, to the extent
applicable, any API(s) Controlled by Company (if any) that are included in a
Product that is deemed to be a Single Agent Product pursuant to Section 3.1(e),
 (y) any grant of rights under the Company Technology to Exploit any Compound or
Product in Japan in the Company Field or (z) any grant of rights under the
Company Technology to Exploit any Compound or Product in Japan in the TESARO
Field.  If requested by TESARO, Company shall grant to TESARO a non-exclusive,
royalty-bearing, non-transferable (except in accordance with Section[***]
 15.4), license, with the right to grant sublicenses as provided in Section
3.2(b), under the Company

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[***] 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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Technology to Exploit Products in Japan on commercially reasonable terms to be
negotiated in good faith and mutually agreed upon by the Parties (such agreement
not to be unreasonably withheld, conditioned or delayed).  If the Parties do not
reach agreement on such terms within ninety (90) days after TESARO’s request for
such a license, the Parties shall select and agree upon a mutually acceptable
independent Third Party expert who is neutral, disinterested and impartial, and
has experience relevant to such licenses.  Each Party may make written and oral
submissions of its position to such expert.  Such expert shall, no later than
ten (10) Business Days after the last submission, select one of the Party’s
positions as his or her final decision, and shall not have the authority to
modify either Party’s position or render any substantive decision other than to
select the position of either TESARO or Company.  A basis of such selection
would be fair compensation to Company for the value of Company Technology as
applied to any or all Products in Japan.  The Parties agree that the decision of
such expert shall be binding on each of them.     

(b)Sublicensing.  TESARO shall have the right to grant sublicenses of the rights
granted by Company under Section 3.2(a) to its Affiliates and Third Parties
through multiple tiers.  Each such sublicense shall refer to and be subordinate
to this Agreement, and shall be consistent in all material respects with the
terms and conditions of this Agreement.  TESARO shall remain responsible for the
performance of this Agreement and the performance of its sublicensees
hereunder.  TESARO shall provide to Company copies of each sublicense with a
Third Party that grants such Third Party the right to directly Develop or
Commercialize a Compound or Single Agent Product in the TESARO Field in any
country or jurisdiction in the TESARO Territory, provided that TESARO shall have
the right to redact commercially sensitive information from such
copies.  Information regarding the scope of the license grants, territory or
term of each such sublicense and the identity of the Third Party shall not be
considered commercially sensitive. 

3.3[***]  

3.4Retained Rights.    Except as exclusively licensed to Company under this
Agreement and otherwise subject to Section 3.1(d), TESARO retains all rights
under the TESARO Technology and TESARO Trademarks: (a) to Exploit any Compound
alone as the sole active pharmaceutical ingredient or in combination with other
active pharmaceutical ingredients, including in a co-packaged or co-formulated
product, in the TESARO Field and throughout the TESARO Territory, whether or not
expressly stated herein; and (b) to Exploit any Compound in combination with one
or more other active pharmaceutical ingredients in the TESARO Field, in each
case ((a) and (b)), without the consent of Company or any Joint Committee.

3.5No Implied Licenses.  All licenses and rights are granted only as expressly
provided in this

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[***] 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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Agreement and no license or other right is or shall be created or granted under
this Agreement by implication, estoppel, or otherwise.  All rights not expressly
granted by a Party under this Agreement are reserved by such Party and may not
be used by the other Party for any purpose.

3.6[***] 

ARTICLE 4

DEVELOPMENT    

4.1General.  Prior to the Effective Date, TESARO commenced Development of the
Initial Product for certain indications in the TESARO Field, including breast
cancer and ovarian cancer.  During the Term, Company shall have the right to
Develop the Compounds, Single Agent Products and Combination Products in the
Company Field in the Company Territory, and TESARO shall retain the right to
Develop the Compounds, Single Agent Products and Combination Products in the
TESARO Field in the TESARO Territory, in each case subject to the terms and
conditions of this Agreement.  Certain aspects of the Parties’ Development of
the Compounds and Products shall be communicated through the JDC, as further
described in ARTICLE 2 and this ARTICLE 4, but neither Party’s Development
activities and decisions require the approval, consent or agreement of the JDC,
JSC, any other Joint Committee, subcommittee, or the other Party except as
expressly provided in this Agreement.

4.2Development Activities

(a)Company Development Activities.  Except as expressly provided in this
Agreement, Company shall be solely responsible for and have sole authority with
respect to, at its own expense, all Development of the Compounds, Single Agent
Products and Combination Products in the Company Field in the Company Territory,
including Development for Monotherapy Use or Combination Use in the Company
Field in the Company Territory.  Company shall conduct such Development in
accordance with the Company Development Plan, which may be updated from time to
time by Company in accordance with Section 4.2(c). 

(b)TESARO Development Activities.  Except as expressly provided in this
Agreement, TESARO shall be solely responsible for and have sole authority with
respect to, at its own expense, all Development of the Compounds, Single Agent
Products and Combination Products in the TESARO Field in the TESARO Territory,
including Development for Monotherapy Use or Combination Use in the TESARO Field
in the TESARO Territory.   

(c)Communication of Development Activities.  A summary of all ongoing and
planned Phase 2 Trials and Phase 3 Trials of Products in the TESARO Field in the
TESARO Territory is attached hereto as Exhibit 4.2(c) (the “TESARO Development
Plan”), and a summary of Company’s planned Clinical Trials of the Products in
the Company Field in the Company Territory will be delivered to TESARO within
[***] after the Effective Date (the “Company Development

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[***] 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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Plan” and, together with the TESARO Development Plan, the “Development
Plans”).  Each Party shall update its Development Plan twice per year for so
long as such Party (or any of its Affiliates or (sub)licensees) is conducting
Development of the Products, and shall deliver such updated Development Plan to
the JDC for review and discussion; provided, that one of such updated
Development Plans shall be delivered no later than [***] after the start of each
Calendar Year.  In addition to such updates, each Party may amend its
Development Plan at any time, and shall deliver such amended Development Plan to
the JDC for review and discussion at its next regularly scheduled meeting.  For
clarity, approval of a Party’s Development Plan by the JDC, JSC or other Party
shall not be required.  Each updated and amended Development Plan shall contain
sufficient details regarding the Development activities described therein for
(a) the other Party to assess potential adverse effects of such Development
activities on the other Party’s ongoing or planned Development activities with
respect to the Products, to the extent that such information is available and
(b) TESARO to prepare the Third Party Development Reports in accordance with
Section 4.2(h).  If either Party reasonably believes that any activity set forth
in the other Party’s Development Plan could adversely affect any of its ongoing
or planned Development activities with respect to the Products, such Party shall
so notify the other Party, stating the basis for its belief, and the JDC shall
meet to discuss such concerns.

(d)Right to Object to Clinical Trials.  Neither Party, nor any of its
Affiliates, licensees or sublicensees, shall conduct or have conducted on its
behalf a Clinical Trial of a Product unless such Party first provides the other
Party with an opportunity to review and, if permitted below, to object to such
Clinical Trial as follows:

(i)The Conducting Party shall provide the draft protocol (or, if not available,
a detailed description of the proposed protocol and trial design) and
investigator’s brochure for such Clinical Trial to the other Party (the
“Reviewing Party”) at least [***] before the first submission of the protocol to
an institutional review board or ethics committee.    

(ii)The Reviewing Party may, but is not obligated to, provide comments on the
draft protocol and investigator’s brochure for such Clinical Trial to the
Conducting Party no later than [***] after receipt of such draft protocol and
investigator’s brochure.  The Conducting Party shall reasonably consider such
comments in good faith.

(iii)In addition, the Reviewing Party may notify the Conducting Party that it
objects to the design for such Clinical Trial (such notice, an “Objection”) no
later than [***] after receipt of the draft protocol and investigator’s brochure
on one or more of the following grounds:

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[***] 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)if Company is the Reviewing Party, Company reasonably determines in good
faith that the proposed Clinical Trial would result in a safety or tolerability
finding that would raise material concerns regarding the clinical benefit of any
Product in the Company Field; or

(2)if TESARO is the Reviewing Party, TESARO reasonably determines in good faith
that the proposed Clinical Trial would result in a safety or tolerability
finding that would raise material concerns regarding the clinical benefit of any
Product in the TESARO Field.

(iv)Any notice of an Objection shall include specific proposals relating to the
design of the Clinical Trial in order to address and overcome the ground(s) for
Objection, and the Parties shall promptly discuss such proposals in good
faith.  If the Parties do not agree on the proposals raised in an Objection
within [***] of the date of such notice, the Conducting Party may conduct the
proposed Clinical Trial in accordance with such draft protocol and
investigator’s brochure.

(v)If the Conducting Party intends to materially change a protocol or
investigator’s brochure for a Clinical Trial of a Product after providing a
draft of such protocol or investigator’s brochure to the Reviewing Party, such
Clinical Trial shall be subject again to the procedures set forth above in this
Section 4.2(d), unless such material change is required or recommended by a
Regulatory Authority, institutional review board or ethics committee, in which
case, the Conducting Party shall only be required to provide as much notice as
is reasonably practicable prior to implementing such change and the Reviewing
Party shall have no right to raise an Objection thereto; provided, that the
review of material changes contemplated by this Section 4.2(d)(v) shall not
require the Conducting Party to terminate or suspend any ongoing Clinical
Trial. 

(e)Clinical Trial Registries.  Each Party shall be responsible, in accordance
with Applicable Law, for registering each Clinical Trial of a Product that such
Party conducts in the appropriate clinical trial registry and posting the
results of such Clinical Trial.    

(f)Sharing of Development Know-How.    

(i)Within [***] after the Effective Date, TESARO shall provide Company with
electronic copies of the INDs relating to Development of the Initial Compound
and Initial Product set forth on Exhibit 4.2(f).     

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[***] 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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(ii)Following the Effective Date: (A) within thirty (30) days after Company’s
reasonable request (provided, that such requests may not be more frequent than
once per Calendar Quarter with respect to any given Product after the first
[***] of Development of such Product by Company), TESARO shall provide to
Company any TESARO Know-How relating to the Development of the Compounds and
Products that is necessary or useful for Company to Develop the Compounds or
Products in the Company Field in the Company Territory, including any such
Know-How relating to the Development of diagnostics with respect to the
Compounds or Products (it being understood and acknowledged by Company that
TESARO is not granting rights to Company that it does not Control under the
Merck License Agreement or AstraZeneca License Agreements, including any rights
relating to the Development of diagnostics with respect to the Compounds or
Products)); (B) the Conducting Party, with respect to any Clinical Trial, shall
provide the other Party with any safety data resulting from such Clinical Trial
in accordance with the PVA or as otherwise determined by the Parties; and (C)
the Conducting Party with respect to any Clinical Trial shall provide the other
Party with a copy of the final clinical study report from such Clinical Trial
promptly following completion thereof.  The Parties shall discuss the logistics
of sharing Know-How pursuant to this Section 4.2(f)(ii) through the JDC.  In the
event Company reasonably determines that any TESARO Know-How that is Controlled
by TESARO pursuant to the Merck License Agreement or any AstraZeneca License
Agreement is necessary to seek Marketing Approval of a Product in the Company
Field, TESARO will use reasonable efforts to obtain such TESARO Know-How from
Merck or AstraZeneca, as the case may be, if TESARO is not in possession of such
TESARO Know-How.     Notwithstanding anything to the contrary in this Agreement,
a Party that is required to provide any Know-How pursuant to this Section
4.2(f)(ii) may, prior to providing such Know-How to the other Party, redact any
[***] “Redactable Information”).

(iii)Each Party shall promptly disclose to the other Party in writing any other
issue related to the Development of the Compounds or Products that could
reasonably impact the other Party’s ongoing or planned Development activities
with respect to the Compounds or Products.  Such disclosure shall contain
sufficient details regarding the issue described therein for the other Party to
assess the impact of such issue on the other Party’s ongoing or planned
Development activities with respect to the Compounds or Products.  If requested
by a Party following such disclosure, the JDC shall meet to discuss the issue. 

(g)Ownership of Development Information and Results.  Company shall own all
Clinical Data and other Know-How generated under Clinical Trials of and other

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[***] 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 of the Compounds and Products in the Company Field in the Company
Territory.  TESARO shall own all Clinical Data and other Know-How generated
under Clinical Trials of and other Development of the Compounds and Products in
the TESARO Field in the TESARO Territory.

(h)Development Reports.  Twice each Calendar Year, each Party shall provide to
the other Party in writing (and verbally to the JDC) a report detailing such
Party’s efforts and progress during the six (6) months prior to such date, as
applicable, to Develop the Compounds and Products in such Party’s Field and
Territory.  Each such report shall describe material Development activities
completed since the last report, including the object and parameters of the
Development, when initiated, when completed and a summary of all material
results; provided,  however, that neither Party shall be required to include any
Redactable Information in such report.  TESARO may use the information contained
in the reports provided by Company pursuant to this Section 4.2(h) to prepare a
development report with respect to the Compounds and Products in the format, and
with the same level of detail, as the report attached hereto as Exhibit 4.2(h)
(a “Third Party Development Report”). TESARO may disclose such Third Party
Development Report to Merck and AstraZeneca to the extent necessary for TESARO
to satisfy its obligations under Sections 3.02(b) and 3.03 of the Merck License
Agreement and Section 4 of the AstraZeneca License Agreements. Prior to
disclosing a Third Party Development Report to Merck or AstraZeneca, TESARO
shall provide a draft of such Third Party Development Report to Company for
review and, upon Company’s request, TESARO shall redact from such Third Party
Development Report any Redactable Information.  TESARO acknowledges and agrees
that the Third Party Development Report shall be sufficient to satisfy its
obligations to provide reports with respect to the Development of the Compounds
and Products by Company under Sections 3.02(b) and 3.03 of the Merck License
Agreement and Section 4 of the AstraZeneca License Agreements.

4.3Development Diligence Obligations. 

(a)Company shall use Commercially Reasonable Efforts to Develop, and to seek
Marketing Approval for, [***] and shall continue to use such efforts until
Marketing Approval is obtained for [***].  For clarity, but without limiting the
foregoing, in no event shall Company be obligated to Develop or seek Regulatory
Approval for [***]. 

(b)Without limitation of Section 4.3(a), if in connection with its exercise of
Commercially Reasonable Efforts, Company determines to cease Development of any
Product(s) for any Initial Indication prior to the achievement of the
Development Milestone(s) or any Regulatory Milestone(s) associated with such
ceased Development, then Company shall promptly notify TESARO in writing

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[***] 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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and present such decision to the JDC at its next regular planned meeting for
discussion and explanation.  If Company determines, in its sole discretion and
consistent with its obligation of Commercially Reasonable Efforts, to recommence
the ceased Development or commence new Development for the Initial Indication or
commence Development of any Product(s) for an Indication that is not an Initial
Indication (in each case, such Indication, a “Notice Indication”), then Company
shall promptly notify TESARO of such decision in writing.  Upon delivery of such
notice, if the Development Milestone(s) or any Regulatory Milestone(s)
associated with the ceased Development of the Initial Indication have not yet
been achieved, then such Development Milestone(s) and Regulatory Milestone(s)
shall be deemed to be amended to continue or replace the ceased Development of
the Initial Indication with the Development of the Notice Indication. 

4.4Compliance with Law.   The Parties will, and will cause their Affiliates and
Third Party subcontractors to, comply with Applicable Law in performing
Development activities with respect to the Compounds and Products, including
those pertaining to the use of laboratory animals, GLP, GMP or GCP, as
appropriate.  

4.5Records.  The Parties will, and will cause their Affiliates and Third Party
subcontractors to, maintain complete and accurate records of all work conducted
in performing Development activities with respect to the Compounds and Products,
and all results, data, Inventions and Know-How made during the performance of
such Development. Subject to a Party’s agreements with Third Parties (provided
that such agreements are entered into in accordance with this Agreement and such
Party has notified the other Party of the existence of such agreements), each
Party shall have unrestricted access to all results, data, Inventions and
Know-How Controlled by such Party or its Affiliates related to any Compound or
Product (not including Combination Products in the TESARO Field) to ensure data
integrity, traceability, acceptability, quality and operational compliance with
all Applicable Law; provided,  however, that neither Party shall have access to
the other Party’s Redactable Information.  Such records shall contain sufficient
detail and be in good scientific and, as appropriate, GLP, GCP, and GMP manner
suitable for patent preparation and filing and regulatory purposes.  The Parties
will maintain or cause to be maintained such records with respect to the
Compounds and each such Product for a period at least five (5) years after
receipt of Marketing Approval of any Product in an ICH region and until there
are no pending or contemplated Drug Approval Applications or Regulatory
Approvals in an ICH region or at least five years have elapsed since the formal
discontinuation of clinical Development of such Product; provided,  however,
that such records shall be retained for a longer period if required by the
applicable Regulatory Authority.  If either Party plans to destroy or discard
any of such records after the retention period has expired, such Party will
notify the other Party in writing.  The Parties will then discuss and decide
whether to send the records to an offsite storage facility, to the other Party,
or another alternative as agreed to by the Parties.

4.6Subcontracting.  Each Party may subcontract the performance of any
Development activities conducted in accordance with this Agreement to any of its
Affiliates or any Third

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Party, provided that such Party shall oversee the performance of any
subcontracted activities in a manner that would be reasonably expected to result
in their successful and timely completion and shall remain responsible for the
performance of such subcontracted activities in accordance with this
Agreement.  Each Party agrees to use reasonable efforts to include in any
contract or other written arrangement with each of its subcontractors a clause
permitting the other Party to exercise its right to inspect any facilities at
which the subcontractor conducts Development activities with respect to the
Compounds or Products (not including Combination Products in the TESARO Field)
under Section 4.7.

4.7Audits.  With respect to any facility or site at which either Party conducts
Development with respect to the Compounds or Products (including, where
commercially reasonable and permitted under the applicable agreement between
such Party and its subcontractor, such subcontractor’s facilities or sites, but
not including Combination Products in the TESARO Field), the other Party will
have the right, exercisable no more than once per Calendar Year (or more often,
but not more than quarterly, if there are material compliance issues), upon
reasonable written notice and during normal business hours, to inspect such site
and facility and any records relating thereto, at its expense, in each case only
to the extent reasonably necessary to verify such Party’s or its subcontractors
compliance with the terms of this Agreement relating to GMP, GLP and GCP that
could reasonably affect the inspecting Party’s Development or Commercialization
of Compounds or Products in its Field.  Such inspection shall be subject to the
confidentiality provisions of this Agreement.  In the event that, during such an
inspection visit, the inspected facilities are found to be non-compliant with
one or more GMP, GLP, GCP standards, the inspecting Party shall so notify the
inspected Party of such non-compliance and the inspected Party shall submit a
proposed recovery/corrective action plan to the other Party within sixty (60)
days after the other Party’s notification to Conducting Party of such
non-compliance.  The foregoing inspection rights shall only be exercised by a
Party to the extent necessary for that Party to Exploit its rights hereunder. 

ARTICLE 5

REGULATORY RESPONSIBILITIES

5.1General.  During the Term, Company shall have the right to obtain and
maintain Regulatory Approvals for the Single Agent Products and Combination
Products in the Company Field in the Company Territory and shall otherwise have
the regulatory responsibilities for Products in the Company Field in the Company
Territory as set forth in this ARTICLE 5; provided,  however, that TESARO shall
have the right to obtain and maintain Marketing Approval for Monotherapy Use of
the Single Agent Products in the Company Field in the Company Territory on the
terms set forth in this ARTICLE 5. TESARO shall retain the right to obtain and
maintain Regulatory Approvals for the Single Agent Products and Combination
Products in the TESARO Field in the TESARO Territory, subject to the terms and
conditions of this Agreement.  Certain aspects of the Parties’ regulatory
activities with respect to the Products shall be communicated through the JDC as
expressly described in ARTICLE 2 and this ARTICLE 5, but neither Party’s
regulatory activities and decisions require the approval, consent

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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or agreement of the JDC, JSC, any other Joint Committee, subcommittee, or the
other Party except as expressly provided in this Agreement.

5.2Regulatory Activities – General. 

(a)Company Regulatory Activities.  Company shall have the sole right and
authority, at its own expense but subject to TESARO’s rights under Section
5.3(b) to file for, obtain and maintain Marketing Approval of the Single Agent
Products for Monotherapy Use in the Company Field, to: (i) develop and implement
the overall regulatory strategy with respect to obtaining Marketing Approval of
the Products in the Company Field in the Company Territory, including Marketing
Approval of the Single Agent Products for Combination Use in the Company Field
in the Company Territory; (ii) prepare, obtain and maintain all Regulatory
Documentation with respect to Products in the Company Field in the Company
Territory; and (iii) subject to Sections 5.7 and 5.9, conduct communications
with the relevant Regulatory Authorities with respect to the Compounds and
Products in the Company Field in the Company Territory.  Regulatory
Documentation shall include, for the purposes of this ARTICLE 5, all INDs, Drug
Approval Applications and Marketing Approvals.

(b)TESARO Regulatory Activities.  TESARO shall have the sole right and
authority, at its own expense, to: (i) develop and implement the overall
regulatory strategy with respect to obtaining Marketing Approval of the Products
in the TESARO Field in the TESARO Territory; (ii) prepare, obtain, and maintain
all Regulatory Documentation to the Products in the TESARO Field in the TESARO
Territory; (iii) subject to Sections 5.7 and 5.9, conduct communications with
the relevant Regulatory Authorities with respect to those Products in the TESARO
Field in the TESARO Territory; and (iv) subject to Section 5.2(a)(ii) and
5.3(b), file for, obtain and maintain Marketing Approval for the Single Agent
Product for Monotherapy Use in the Company Field in the Company Territory. 

(c)Communication of Regulatory Activities.  At least [***] prior to filing a
first Drug Approval Application for a Single Agent Product in the TESARO Field
in any country or jurisdiction in the TESARO Territory, TESARO shall use
reasonable efforts to deliver to the JDC a summary of its planned activities
with respect to obtaining Marketing Approval for the Single Agent Products in
the TESARO Field throughout the TESARO Territory (the “TESARO Registration
Plan”).  At least [***] prior to filing a first Drug Approval Application for a
Product in the Company Field in any country or jurisdiction in the Company
Territory, Company shall use reasonable efforts to deliver to the JDC a summary
of its planned activities with respect to obtaining Marketing Approval for the
Products in the Company Field throughout the Company Territory (the “Company
Registration Plan” and, together with the TESARO Registration Plan, the
“Registration Plans”).  Each Party shall update its Registration Plan

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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once per Calendar Quarter for so long as such Party (or any of its Affiliates or
(sub)licensees) is seeking Marketing Approval for the Products, and shall
deliver such updated Registration Plan to the JDC for review and discussion (but
not approval).  For clarity, approval of a Party’s Registration Plan by the JDC
or other Party shall not be required; provided that the Registration Plan shall
be consistent with the rights of that Party.  Each Registration Plan shall
contain: (i) a list of each country and jurisdiction in which the applicable
Party plans to file a Drug Approval Application for each Product; (ii) for each
country and jurisdiction described in clause (i), (A) the expected timing of
submission of the Drug Approval Application, (B) the expected approval date of
the Drug Approval Application, (C) the proposed indication(s) for which approval
will be sought, and (D) the anticipated date of First Commercial Sale of such
Product in such country and jurisdiction (or first commercial sale with respect
to Single Agent Products in the TESARO Field).  If, following delivery of any
Registration Plan by a Party, the other Party reasonably believes that any
activity set forth in such Registration Plan could adversely affect any of its
ongoing or planned Development or regulatory activities with respect to the
Products, such Party shall so notify the other Party and the JDC shall meet to
discuss such concerns.

(d)Regulatory Updates.  Company shall promptly provide TESARO with notice of the
granting of any Marketing Approval of a Product obtained by Company, and TESARO
shall promptly provide Company with notice of the granting of any Marketing
Approval of a Single Agent Product obtained by TESARO.  TESARO may disclose
information to Merck and AstraZeneca with respect to Company’s regulatory
activities with respect to the Products in the Company Field in the Company
Territory consistent with the level of detail set forth in the Third Party
Development Reports, to the extent necessary for TESARO to comply with its
reporting requirements under Section 4.01(f) of the Merck License Agreement and
Section 4 of each of the AstraZeneca License Agreements.  Notwithstanding the
foregoing, prior to disclosing such information to Merck or AstraZeneca, TESARO
shall provide a draft of such disclosure to Company for review and, upon
Company’s request, TESARO shall redact from such disclosure any Redactable
Information.  TESARO acknowledges and agrees that the information that TESARO is
permitted to disclose to Merck and AstraZeneca pursuant to this Section 5.2(d)
shall be sufficient to satisfy its obligations to provide information under
Section 4.01(f) of the Merck License Agreement and Section 4 of each of the
AstraZeneca License Agreements.

5.3INDs and Marketing Approvals.    

(a)INDs.    

(i)Prior to the Effective Date, TESARO filed the following INDs with respect to
the Initial Product: IND 100,996 (Ovarian) and IND 117,580

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(Breast).  Following the Effective Date, TESARO shall continue to maintain such
INDs to the extent required for Company to initiate and conduct the Clinical
Trials set forth in the Company Development Plan. 

(ii)Following the Effective Date, Company shall prepare, file and maintain all
INDs for the Products that are required for Company to conduct the Clinical
Trials set forth in the Company Development Plan, including any Clinical Trials
of a Single Agent Product in combination with any other any pharmaceutical
product and any Clinical Trials of a Combination Product.

(b)Marketing Approvals – Single Agent Products for Monotherapy Use.    

(i)  TESARO shall have the sole right and authority to prepare, obtain and
maintain all Drug Approval Applications and Marketing Approvals for any
Monotherapy Use in the TESARO Field in the TESARO Territory.

(ii)  Company shall have the sole right and authority to prepare all Drug
Approval Applications for any Monotherapy Use in the Company Field in the
Company Territory.  TESARO shall have the first right, and Company shall have
the second right, to submit any such Drug Approval Application to a Regulatory
Authority in any country or jurisdiction in the Company Field, and to obtain and
maintain the resulting Marketing Approval, in accordance with the terms set
forth in the remainder of this Section 5.3(b). 

(iii)If Company desires to submit a Drug Approval Application for a Monotherapy
Use in the Company Field to a Regulatory Authority in any country or
jurisdiction in the Company Territory, Company shall so notify TESARO no later
than [***] prior to the date on which Company desires to submit such Drug
Approval Application to such Regulatory Authority.  Within [***] after receipt
of such notice, TESARO shall deliver a written notice to Company (such notice, a
“Monotherapy Registration & Distribution Notice”) stating: (x) whether or not
TESARO will submit such Drug Approval Application, and obtain and maintain the
resulting Marketing Approval on behalf of the Company in accordance with Section
5.3(b)(iii); (y) whether or not TESARO has submitted a Drug Approval Application
for, or obtained Marketing Approval of, the corresponding Monotherapy Use in the
TESARO Field in the applicable country or jurisdiction; and (z) whether or not
TESARO will Distribute the applicable Single Agent Product in the applicable
country or jurisdiction in accordance with Section 6.2(c). 

(iv)  In the event that TESARO delivers a Monotherapy Registration &
Distribution Notice stating that TESARO will submit the applicable Drug Approval
Application for a Monotherapy Use in the Company Field, and

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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obtain and maintain the resulting Marketing Approval, in the applicable country
or jurisdiction in the Company Territory, then the provisions of this
Section 5.3(b)(iv)  shall apply with respect to such Drug Approval Application
and Marketing Approval.    

 

(1)No later than [***] prior to the date on which Company desires to submit such
Drug Approval Application to the applicable Regulatory Authority, Company shall
submit such Drug Approval Application to the JDC for review.  Within [***]
following submission of a such Drug Approval Application to the JDC the JDC
shall review such Drug Approval Application to reasonably determine whether it
satisfies the appropriate efficacy and safety criteria outlined in the
applicable protocol and notify Company of the results of such review. 

(2)If a notice given by the JDC in accordance with clause (1) above indicates
that the applicable Drug Approval Application does not satisfy the appropriate
efficacy and safety criteria outlined in the applicable protocol, then TESARO
shall have no obligation to submit such Drug Approval Application to the
applicable Regulatory Authority unless and until Company revises such Drug
Approval Application to satisfy the appropriate efficacy and safety criteria
outlined in the applicable protocol.

(3)If a notice given by the JDC in accordance with clause (1) above indicates
that the applicable Drug Approval Application satisfies the appropriate efficacy
and safety criteria outlined in the applicable protocol, then TESARO shall
submit such Drug Approval Application to the applicable Regulatory Authority in
the applicable country or jurisdiction in the Company Field upon the request of
Company; provided,  however, that (x) if TESARO previously submitted a Drug
Approval Application for the corresponding Monotherapy Use in the TESARO Field
in such country or jurisdiction, then TESARO shall not be obligated to submit
Company’s Drug Approval Application until TESARO’s Drug Approval Application is
approved or finally rejected by the applicable Regulatory Authority and (y) if
Marketing Approval for the corresponding Monotherapy Use in the TESARO Field has
been previously granted in such country or jurisdiction, such Drug Approval
Application in the Company Field shall be submitted as a Supplemental
Application to such Marketing Approval.  TESARO shall pay any filing fees
required to submit any Drug Approval Application or Supplemental Application, as
applicable, or to

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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obtain or maintain the resulting Marketing Approval, to such Regulatory
Authority and shall either seek reimbursement of such filing fees from Company
pursuant to Section 8.13 or deduct such filing fees from the TESARO
Prostate-Approved Single Agent Product Net Sales as part of calculating Alliance
Payments in accordance with Exhibit 8.3.   

(4)Upon TESARO’s submission of a Drug Approval Application or Supplemental
Application to a Regulatory Authority in accordance with clause (3) above,
TESARO shall, and hereby does, appoint Company as its authorized agent to assume
primary responsibility with respect to such Drug Approval Application or
Supplemental Application, as applicable (and the resulting Marketing Approval)
and all associated communications with such Regulatory Authority; provided that
Company complies with all Applicable Laws in connection with such communications
and keeps TESARO informed of all associated communications in accordance with
Section 5.4(b).  In furtherance of the foregoing, at Company’s request prior to
the filing of such Drug Approval Application or Supplemental Application, as
applicable, TESARO shall execute a letter, in a mutually agreed form, appointing
Company as authorized agent to assume primary responsibility with respect to
such Drug Approval Application or Supplemental Application, as applicable, and
the Parties shall submit such letter to the applicable Regulatory Authority.   

(5)If the applicable Regulatory Authority approves a Drug Approval Application
or Supplemental Application submitted by TESARO in accordance with clause (3)
above, then, subject to Company’s rights under clause (4) above, TESARO shall be
the holder of the resulting Marketing Approval in the Company Field and, if
applicable, shall remain as the holder of the corresponding Marketing Approval
in the TESARO Field.  Except with respect to a Change of Control, TESARO shall
not, sell, transfer or assign any such Drug Approval Application, Supplemental
Application or Marketing Approval with respect to the Company Field (or grant
any Third Party any rights relating to such Marketing Approval) without
Company’s prior written consent, such consent not to be unreasonably
withheld.  If TESARO desires to withdraw or to cease to maintain any such
Marketing Approval, TESARO shall so notify Company at least [***] prior to the
date upon which TESARO intends to withdraw or cease to maintain such Marketing
Approval and, upon Company’s request prior to the expiration of such [***],
TESARO shall assign

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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such Marketing Approval to Company and shall take all actions necessary to
effectuate such assignment, and the Parties shall negotiate in good faith and
agree upon any modifications to this Agreement necessary to enable Company to
maintain such Marketing Approval. 

(v)  In the event that (A) TESARO delivers a Monotherapy Registration &
Distribution Notice stating that it will not submit the applicable Drug Approval
Application for a Monotherapy Use in the Company Field in a country or
jurisdiction in the Company Territory, and obtain and maintain the resulting
Marketing Approval or (B) TESARO fails to deliver a Monotherapy Registration &
Distribution Notice within [***] after Company notifies TESARO of its desire to
submit a Drug Approval Application for a Monotherapy Use in the Company Field in
a country or jurisdiction in the Company Territory, then, in each case ((A) and
(B)), the provisions of this Section 5.3(b)(v) shall apply with respect to such
Drug Approval Application and Marketing Approval. 

(1)Prior to submitting such Drug Approval Application to the applicable
Regulatory Authority in such country or jurisdiction, Company shall provide
TESARO with a draft of such Drug Approval Application, and TESARO may provide
comments on such Drug Approval Application, which Company shall consider in good
faith; provided,  however, that Company may redact any Redactable Information
prior to providing such draft to TESARO. 

(2)Following TESARO’s review of a Drug Approval Application in accordance with
clause (1) above, Company may submit such Drug Approval Application to the
applicable Regulatory Authority at any time and shall promptly notify TESARO
after such submission.  Company shall pay any filing fees required to submit
such Drug Approval Application to such Regulatory Authority or to obtain or
maintain the resulting Marketing Approval.  Company shall be solely responsible
for all communications with such Regulatory Authority with respect to such Drug
Approval Application; provided that Company shall keep TESARO informed of all
associated communications in accordance with Section 5.4(b).

(3)If the applicable Regulatory Authority approves a Drug Approval Application
submitted by Company in accordance with clause (2) above, Company shall be the
holder of the resulting Marketing Approval. 

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(vi)     If at any time Company is the holder of any Marketing Approval for
Monotherapy Use in the Company Field, upon TESARO’s request at any time after
the grant of such Marketing Approval, Company shall assign and transfer such
Marketing Approval to TESARO and shall take all actions necessary to effectuate
such assignment and transfer, and the provisions of clauses (3) (with respect to
fees), (4) and (5) of Section 5.3(b)(iv) shall thereafter apply to such
Marketing Approval. 

(c)Marketing Approvals – Single Agent Products for Combination Use. 

(i)TESARO shall have the sole right and authority to prepare, obtain and
maintain all Drug Approval Applications and Marketing Approvals for any
Combination Use in the TESARO Field in the TESARO Territory. 

(ii)Company shall have the sole right and authority to prepare, obtain and
maintain all Drug Approval Applications and Marketing Approvals for any
Combination Use in the Company Field in the Company Territory; provided,
 however, Company may, in its sole discretion, seek Marketing Approval for such
Combination Use using a Supplemental Application to a Marketing Approval for
Monotherapy Use in the Company Field, in which case the corresponding provisions
of Section 5.3(b) shall apply (substituting “Combination Use in the Company
Field” for “Monotherapy Use in the Company Field” in the provisions thereof)
with respect to the preparation, submission and maintenance of such Supplemental
Application and the resulting Marketing Approval.  For clarity, Company is not
granting any rights to TESARO under this Agreement with respect to any such
Combination Use.    

(iii)Prior to submitting any Drug Approval Application for a Combination Use in
the Company Field in the Company Territory (and, in any event, at least [***] in
advance of submission) in accordance with this Section 5.3(c), a Party shall
provide the other Party with a draft of relevant portions of the Drug Approval
Application as determined by the JDC, and the other Party may provide comments
on any portions of such Drug Approval Application that relate to a Compound,
which the submitting Party shall consider in good faith; provided, however,
that, prior to submitting such draft to the other Party, the submitting Party
may redact any Redactable Information from such Drug Approval Application.

(d)Marketing Approvals – Combination Products.

(i)Subject to Sections 3.1(d) and 3.4, TESARO shall have the sole right and
authority to prepare, obtain and maintain all Drug Approval Applications and
Marketing Approvals for any Combination Product in the TESARO Field in the
TESARO Territory.

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(ii)Company shall have the sole right and authority to prepare, obtain and
maintain all Drug Approval Applications and Marketing Approvals for the
Combination Products in the Company Field in the Company Territory.  For
clarity, Company is not granting any rights to TESARO under this Agreement with
respect to any such Combination Product.  

(iii)Prior to submitting any Drug Approval Application for a Combination Product
in the Company Field in the Company Territory (and, in any event, at least [***]
in advance of submission) in accordance with this Section 5.3(d)(iii), Company
shall provide TESARO with a draft of relevant portions of the Drug Approval
Application as determined by the JDC, and TESARO may provide comments on any
portions of such Drug Approval Application that relate to a Compound, which
Company shall consider in good faith; provided,  however, that, prior to
providing such drafts to TESARO, Company may redact any Redactable Information.

5.4Interactions with Regulatory Authorities.

(a)Regulatory Meetings.  Where Applicable Law so permits, each Party shall have
the right to have two (2) representatives participate in all material meetings,
conferences and discussions between the other Party and the applicable
Regulatory Authority with respect to any Compound or Product (provided that such
representatives shall not be actively involved in seeking Regulatory Approval
for a product other than a Product in any indication that will be discussed at
such meeting, conference or discussion); provided,  however, that [***].  Each
Party shall provide the other Party with reasonable advance notice (and, in any
event, at least five (5) Business Days advance notice) of all such meetings,
conferences and discussions and all copies of all relevant information with
respect to such meetings, conferences and discussions; provided,  however, that,
prior to providing such information to the other Party, the providing Party may
redact any Redactable Information. 

(b)Regulatory Correspondence.  Each Party shall provide the other Party with
drafts of any material Regulatory Documentation related to a Party’s Development
or Commercialization of a Product (excluding Drug Approval Applications and
Supplemental Applications, which are governed by Sections 5.3(b), 5.3(c) and
5.3(d)) that such Party plans to submit to any Regulatory Authority reasonably
in advance of submission (and, in any event, at least five (5) Business Days in
advance of submission, if practicable, and otherwise, with as much notice as
practicable), and the other Party may provide comments on such Regulatory
Documentation, which the submitting Party shall consider in good faith;
provided,  however, that the submitting Party may, prior to providing such
Regulatory Documentation to the other Party, redact any Redactable
Information.  Notwithstanding anything to the contrary in this Agreement, in no
event shall

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Company be obligated to provide TESARO with any DMF Equivalents with respect to
any Combination Product Developed by Company.  For clarity, this Section 5.4(b)
shall apply with respect to any proposed changes to the label for a Product
(other than proposed label changes set forth in a Supplemental Application
submitted in accordance with Section 5.3(b)(i)  or 5.3(c)(ii)). 

(c)Post-Marketing Commitments.  Each Party shall perform all activities
necessary to satisfy any post-marketing requirements imposed by a Regulatory
Authority with respect to a Single Agent Product in such Party’s Field, in
accordance with the timelines established by such Regulatory Authority.

5.5Sharing of Regulatory Documentation.    

(a)Initial Transfer of Regulatory Documentation.  Within [***] after the
Effective Date, TESARO shall deliver to Company electronic copies (unless
otherwise required by Applicable Law) of all Regulatory Documentation relating
to the Initial Compound and Initial Product set forth on Exhibit 5.5(a).   

(b)Sharing of Safety Data.  Upon a Party’s request or as required under the PVA,
each Party shall provide the other Party with any safety data relating to the
Compounds or Products that is necessary for such other Party to prepare, obtain
or maintain any Regulatory Approval that such Party has a right or obligation to
prepare, obtain or maintain pursuant to this ARTICLE 5.  The Parties shall
discuss the logistics of sharing safety data pursuant to this Section 5.5(b)
through the JDC.    

(c)Ongoing Sharing of Regulatory Documentation.  Upon a Party’s reasonable
request, each Party shall provide the other Party with copies of any Regulatory
Documentation or Know-How Controlled by such Party that relates to a Compound or
Product, to the extent that such Regulatory Documentation or Know-How is
required or reasonably expected to be required for the other Party to prepare,
obtain or maintain any Regulatory Approval for a Compound or Product that such
other Party has a right or obligation to prepare, obtain or maintain under this
ARTICLE 5.  The Parties shall discuss the logistics of sharing Regulatory
Documentation pursuant to this Section 5.5(c) through the JDC.  Notwithstanding
anything to the contrary in this Agreement, a Party that is required to provide
Regulatory Documentation or Know-How pursuant to this Section 5.5(c) may, prior
to providing such Regulatory Documentation or Know-How to the other Party,
redact any Redactable Information. Notwithstanding anything to the contrary in
this Agreement, in no event shall Company be obligated to provide TESARO with
any DMF Equivalents with respect to any Combination Product Developed by
Company.

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[***] 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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5.6Rights of Reference. 

(a)Rights of Reference Granted to Company.  Subject to the terms and conditions
of this Agreement, TESARO (on behalf of itself and its Affiliates) hereby grants
to Company a non-exclusive Right of Reference (with the right to grant further
Rights of Reference to any of Company’s Affiliates, sublicensees or Third Party
distributors that will hold the Marketing Approval for any Product in the
Company Field in any country or jurisdiction in the Company Territory) to any
Regulatory Documentation Controlled by TESARO (including the IND for the Single
Agent Product filed by Merck prior to the Effective Date and the corresponding
Phase 1 Clinical Trial data) that is required or reasonably expected to be
required to obtain or maintain any Regulatory Approval of a Compound or Product
in the Company Field in the Company Territory that Company is permitted to
obtain or maintain under Section 5.2(a) or Section 5.3 (such Regulatory
Documentation, the “TESARO Regulatory Documentation”), for the sole purpose of
preparing, obtaining and maintaining such Regulatory Approval.  Company shall
notify TESARO of any additional right of reference granted by Company in
accordance with this Section 5.6(a), and shall obtain from the referee an
undertaking that it shall comply with applicable provisions of this Agreement
and Applicable Law with respect thereto.

(b)Rights of Reference Granted to TESARO.  Subject to the terms and conditions
of this Agreement, Company (on behalf of itself and its Affiliates) hereby
grants to TESARO a non-exclusive Right of Reference (with the right to grant
further Rights of Reference to any of TESARO’s Affiliates, (sub)licensees or
Third Party distributors that will hold the Marketing Approval for any Single
Agent Product in the TESARO Field in any country or jurisdiction in the TESARO
Territory) to any Regulatory Documentation Controlled by Company that is
required or reasonably expected to be required to obtain or maintain any
Regulatory Approval of a Compound or Product that TESARO is permitted to obtain
or maintain under Section 5.2(b) or Section 5.3 (the “Company Regulatory
Documentation”), for the sole purpose of preparing, obtaining and maintaining
such Regulatory Approval; provided,  however, that such Right of Reference shall
not apply to the following, (i) any DMF equivalent for a Combination Product,
(ii) any portion of any Company Regulatory Documentation that includes CMC
information with respect to a Combination Product or (iii) any portion of any
Company Regulatory Documentation that relates to any compound that is not a
Compound or any product that is not a Product.  TESARO shall notify Company of
any additional right of reference granted by TESARO in accordance with this
Section 5.6(b), and shall obtain from the referee an undertaking that it shall
comply with applicable provisions of this Agreement and Applicable Law with
respect thereto.

(c)Documentation.  If requested by a Party, the other Party shall provide any
signed statement that authorizes any Right of Reference granted to such Party
under this

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[***] 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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Section 5.6 that is required by Applicable Law or the Regulatory Authority in
the applicable country or jurisdiction.  In the event that any Affiliate,
licensee, sublicensee or Third Party distributor of a Party holds any Regulatory
Documentation to which the other Party is granted a Right of Reference under
this Section 5.6, such Party will cause such Affiliate, licensee, sublicensee or
Third Party distributor to grant a Right of Reference to the other Party to the
same extent that such Party is required to grant such Right of Reference under
this Section 5.6.

(d)Access.  The Rights of Reference granted pursuant to this Section 5.6 shall
include the right to access all Know-How included or referenced in the
applicable Regulatory Documentation; provided,  however, that such right of
access shall not apply to any Know-How that is Redactable Information.

5.7Adverse Event Reporting and Safety Data Exchange.

(a)Company Responsibilities. Company will maintain the global safety database,
safety monitoring, pharmacovigilance surveillance, compliance and filing of all
required safety reports to all Regulatory Authorities in the Company Territory
with respect to any Combination Product (including any FDC) Developed by Company
in the Company Field and, to the extent required by Applicable Law, any
Combination Use of a Single Agent Product solely in the Company Field, including
annual safety reports, throughout the Development and Commercialization of such
Combination Product or combination regimen, as applicable.

(b)TESARO Responsibilities. TESARO will maintain the global safety database,
safety monitoring, pharmacovigilance surveillance, compliance and filing of all
required safety reports to all Regulatory Authorities in the Company Territory
and TESARO Territory with respect to each Single Agent Product (other than with
respect to any Combination Use in the Company Field for which Company is
responsible pursuant to Section 5.7(a)) and with respect to any Combination
Product Developed by TESARO in the TESARO Field, including annual safety
reports, throughout the Development and Commercialization of such Single Agent
Product or Combination Product, as applicable. 

(c)Safety Information Exchange; Pharmacovigilance Agreement.  The Parties shall
cooperate to develop methods or procedures for sharing information relating to
the clinical experiences with respect to the Products in accordance with safety
reporting requirements of the respective Regulatory Authorities and as necessary
to comply with Applicable Law.    Specific details regarding the management of
safety data (including adverse events reports) related to the Development and
Commercialization of the Products will be delineated in a separate global
pharmacovigilance agreement (the “PVA”).  The Parties shall agree upon the

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[***] 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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terms of the PVA no later than the anticipated date of the First Commercial Sale
or clinical activity with respect to any Product in the Company Field in the
Company Territory.  In the event of any conflicts or inconsistencies between the
PVA and this Agreement, the terms of the PVA shall take precedence for matters
relating to pharmacovigilance.    

5.8Medical Affairs.  The Parties shall review and discuss medical affairs
activities with respect to the Products (including the matters described in this
Section 5.8 and investigator initiated studies, cooperative group studies, early
access programs, HECOR studies, RWE and company-sponsored medical affairs
studies) through the JDC (or, if created by the JDC, a joint medical affairs
subcommittee).

(a)Medical Science Liaisons.  Each Party shall determine independently how and
if to utilize and deploy its medical science liaisons for activities relating to
the Products in the Company Territory, provided that any arrangements a Party
makes with its medical science liaisons are subject to the provisions of
Sections 5.8(b) and 5.8(c).

(b)Responses to Medical Inquiries.    

(i)Each Party shall apply its standard guidelines and procedures for determining
and providing appropriate responses to medical inquiries for which it is
responsible according to this Section 5.8(b).  Each Party shall ensure that any
such response procedures and standard response documents comply with Applicable
Law. 

(ii)Company shall be responsible for dealing with medical inquiries about the
Products in the Company Field in the Company Territory.  TESARO shall refer any
medical inquiries that it receives about the Products in the Company Field in
the Company Territory to Company or such Persons as Company may designate from
time to time.

(iii)TESARO shall be responsible for dealing with medical inquiries about the
Products in the TESARO Field in the TESARO Territory.  Company shall refer any
medical inquiries that it receives about the Products in the TESARO Field in the
TESARO Territory or such Persons as TESARO may designate from time to time. 

(iv)Each Party shall provide the other Party, on a recurring basis, with access
to current medical affairs communications and training materials, including
anticipated questions and answers, relating to the Products and as used by such
Party’s medical affairs personnel in the Company Territory.  Each Party will
conduct training of its medical affairs personnel on the use of such materials
and on following the procedures of such training materials.  Company may respond
to any medical inquiries about the Products in the TESARO Field in the Company
Territory strictly in accordance with the information contained in the medical
affairs communications materials provided by TESARO.  TESARO may respond to any
medical inquiries about

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[***] 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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the Products in the Company Field in the Company Territory strictly in
accordance with the information contained in the medical affairs communications
materials provided by Company.  Any medical inquiry seeking or requiring
information not contained in such materials shall be referred by the receiving
Party to the other Party or such Persons as the other Party may designate from
time to time.

(c)Conferences and Symposia.  Except for any Third Party medical education
activities (e.g., accredited CME programs) over which a Party has no control or
influence beyond providing funding or as otherwise agreed by the Parties: (i)
Company shall not, and shall ensure that its Affiliates do not, participate in
or sponsor any formal presentation or panel or medical booths with respect to
any Product in the TESARO Field at any conference or symposia, or provide any
information with respect to any Product in the TESARO Field at any conference or
symposia, without the prior consent of TESARO; and (ii) TESARO shall not, and
shall ensure that its Affiliates do not, participate in or sponsor any formal
presentation or panel or medical booths with respect to any Product in the
Company Field at any conference or symposia, or provide any information with
respect to any Product in the Company Field at any conference or symposia,
without the prior consent of Company. 

5.9Recalls and Voluntary Withdrawals.

(a)Notification.  Each Party shall notify the other Party in writing promptly
following its determination that any event, incident or circumstance related to
safety issues or regulatory concerns has occurred that is reasonably likely to
result in the need for a recall, market suspension or market withdrawal of a
Product, and shall include in such notice (a “Potential Recall Notice”) the
reasoning behind such determination and any supporting facts.  Such Potential
Recall Notice shall be given no later than five (5) Business Days after such
determination is made; provided,  however, that if any Regulatory Authority (i)
threatens or initiates any action to remove a Product from the market in any
country or (ii) requires a Party, or any of its Affiliates or (sub)licensees, to
distribute a “Dear Doctor” letter or its equivalent regarding the use of a
Product in such Party’s Field, then, in either case ((i) or (ii)), the Potential
Recall Notice shall be given within one (1) Business Day after such Party
becomes aware of the action, threat or requirement (as applicable).  TESARO
shall be permitted to disclose any Potential Recall Notice delivered by Company
to Merck to extent necessary to satisfy its obligations under Section 4.01(g) of
the Merck License Agreement.

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[***] 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)Decision-Making.  If the Party that receives a Potential Recall Notice does
not agree with the determination or recommendation of the other Party that the
recommended recall, market suspension or market withdrawal of the applicable
Product is advisable or necessary, then the Parties shall promptly meet to
discuss whether to conduct such recall, market suspension or market withdrawal. 
If the Parties do not reach agreement on whether to conduct such recall, market
suspension or market withdrawal within five (5) Business Days after a Potential
Recall Notice is given, then: (i) if such Product is a Single Agent Product or a
Combination Product Developed by TESARO in the TESARO Field, TESARO shall have
the final decision-making authority with respect to such recall, market
suspension or market withdrawal; and (ii) if such Product is a Combination
Product Developed by Company in the Company Field, Company shall have the final
decision-making authority with respect to such recall, market suspension or
market withdrawal.  Notwithstanding the foregoing, the Parties shall abide by
any decision of the applicable Regulatory Authority with respect to any recall,
market suspension or market withdrawal of a Product and, in the event TESARO
notifies Company that it believes a recall, market suspension or market
withdrawal of a Combination Product Developed by Company in the Company Field
should occur due to safety concerns regarding the Compound included therein,
then TESARO shall have the final decision-making authority with respect to such
recall, market suspension or market withdrawal.    

(c)Recall Procedure and Recall Expenses.  TESARO shall be responsible for
implementing, directing and administering (including communicating with
Regulatory Authorities with respect to) any recall, market suspension or market
withdrawal of a Single Agent Product or a Combination Product Developed by
TESARO in the TESARO Field that is determined to be advisable or necessary in
accordance with Section 5.9(b) at its own expense, provided that Company shall,
upon the request of TESARO, provide any reasonable assistance in implementing or
administering such recall, market suspension or market withdrawal.  Company
shall be responsible for implementing, directing and administering (including
communicating with Regulatory Authorities with respect to) any recall, market
suspension or market withdrawal of a Combination Product Developed by Company in
the Company Field that is determined to be advisable or necessary in accordance
with Section 5.9(b) at its own expense, provided that TESARO shall, upon the
request of Company, provide any reasonable assistance in implementing or
administering such recall, market suspension or market withdrawal. 

(d)Recall Records.  Each Party shall maintain records of all sales of the
Products to direct accounts sufficient to administer a recall until the later
of: (a) the third (3rd) anniversary of the last day of the Term; (b) the third
(3rd) anniversary of the last sale of any Product; (c) the last expiration date
of the last Product sold by or on behalf of such Party; or (d) the expiration of
any period as may be required under any Applicable Law.

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[***] 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)Public Statements regarding Recalls.  TESARO shall be solely responsible for
making all public statements in respect of any recall, market suspension or
market withdrawal of any Single Agent Product or any Combination Product
Developed by TESARO in the TESARO Field.  Before issuing any such public
statement that contains the name of or that could reasonably be construed to
refer to Company or any of its Affiliates, TESARO shall provide Company with a
copy of such public statement and reasonably consider the comments of
Company.  TESARO shall comply with any request by Company to remove any of its
Confidential Information (except to the extent such information is required by
Applicable Law to be disclosed).  Company shall be solely responsible for making
all public statements in respect of any recall, market suspension or market
withdrawal of any Combination Product Developed by Company in the Company
Field.  Before issuing any such public statement that contains the name of or
that could reasonably be construed to refer to TESARO or any of its Affiliates,
Company shall provide TESARO with a copy of such public statement and reasonably
consider the comments of TESARO.  Company shall comply with any request by
Company to remove any of its Confidential Information (except to the extent such
information is required by Applicable Law to be disclosed).  The provisions of
Section 11.5 shall not apply to a public statement made under this Section
5.9(e).

5.10Subcontracting.  Each Party may subcontract the performance of any
activities conducted in accordance with this ARTICLE 5 to any of its Affiliates
or any Third Party, provided that such Party shall oversee the performance of
any subcontracted activities in a manner that would be reasonably expected to
result in their successful and timely completion and shall remain responsible
for the performance of such subcontracted activities in accordance with this
Agreement.

ARTICLE 6

COMMERCIALIZATION

6.1General.  During the Term, Company shall have the right to Commercialize the
Products in the Company Field in the Company Territory, and TESARO shall retain
the right to Commercialize the Products in the TESARO Field in the TESARO
Territory, in each case subject to the term and conditions of this ARTICLE
6.  Certain aspects of the Parties’ Commercialization of the Products shall be
subject be communicated through the JCC, as expressly described in ARTICLE 2 and
this ARTICLE 6, to the extent permitted by Applicable Law, but neither Party’s
Commercialization activities and decisions require the approval, consent or
agreement of the JCC, JSC, any other Joint Committee, subcommittee, or the other
Party except as expressly provided in this Agreement.

6.2Commercialization Activities. 

(a)Company Commercialization Activities – In General.  Subject to Sections
6.2(c) and 6.2(d), Company shall be solely responsible for and have sole
authority

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[***] 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 respect to, at its own expense, all aspects of the Commercialization of the
Products in the Company Field in the Company Territory, including all Fixed Dose
Combination Products Developed by Company in the Company Field.     

(b)TESARO Commercialization Activities – In General.   TESARO shall be solely
responsible for and have sole authority with respect to, at its own expense, all
aspects of the Commercialization of the Products in the TESARO Field in the
TESARO Territory. 

(c)Distribution Activities.    

(i)Notwithstanding anything to the contrary in this Agreement, TESARO shall be
solely responsible for and have sole authority with respect to all aspects of
the Distribution of Single Agent Products in the TESARO Field in the TESARO
Territory and in the Company Field in the Company Territory.  Company hereby
grants TESARO, and TESARO hereby accepts, the exclusive authority and
responsibility to Distribute each Single Agent Product in the Company Field in
each country or jurisdiction where such Single Agent Product has received
Marketing Approval for Monotherapy Use in the Company Field during the Term. 
Notwithstanding the foregoing, Company shall have the right and authority to
Distribute a Single Agent Product in the Company Field in a country or
jurisdiction to the extent permitted under Section 6.4.  The JCC shall discuss
and seek to reach alignment with respect to key aspects of Distribution of a
Single Agent Product in countries or jurisdictions where such Single Agent
Product has received Marketing Approval for Monotherapy Use in both the TESARO
Field and Company Field. 

(ii)Company shall be solely responsible for and have sole authority with respect
to, at its own expense, all aspects of the Distribution of the Combination
Products in the Company Field in the Company Territory.

(iii)In the event that a Party receives any orders for a Product in a country or
jurisdiction where the other Party is responsible for Distributing, or that the
other Party is responsible for Distributing, such Party shall refer such orders
to the distributing Party. 

(iv)TESARO shall prepare and maintain complete and accurate written records and
accounts with respect to Distribution activities conducted pursuant to this
Section 6.2(c) in conformity with Applicable Law and TESARO’s standard
practices, provided that in no case shall such records be maintained for less
than three (3) years following the Calendar Year to which such records pertain
(or any longer period required by Applicable Law).

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[***] 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)Pricing Matters.  

(i)Subject to Section 6.2(d)(iv), TESARO shall be solely responsible for and
shall have final decision-making authority with respect to all decisions
regarding the prices charged and discounts, rebates and other sale and
reimbursement terms and conditions (collectively, “Pricing Terms”) for the
Single Agent Products in the Company Field in the Company Territory.    

(ii)TESARO shall be solely responsible for and shall have final decision-making
authority with respect to all decisions regarding Pricing Terms for the Products
in the TESARO Field in the TESARO Territory.

(iii)Company shall be solely responsible for and shall have final
decision-making authority with respect to all decisions regarding Pricing Terms
for the Combination Products in the Company Field in the Company Territory. 

(iv)[***]    

(e)Commercialization Plans.  Each Party shall submit to the JCC a high-level
summary of its commercialization plans for Products on an annual basis.  Each
such summary shall include the following topics: Product labeling, contracted
services, brand vision and lifecycle management, package design and
configuration, positioning and messaging, branding and Trademarks.  The JCC
shall review and discuss such commercialization plans, and seek to reach
alignment with respect to key Commercialization issues related to the Products
reflected in such plans, such as Product labeling, strategic branding elements,
brand security, brand integrity, customer targeting, product positioning and
promotional programs (e.g. speaker programs and payer activities).  For clarity,
approval of a Party’s commercialization plan by the other Party, the JCC or JSC
shall not be required. 

6.3Commercialization Diligence Obligations.

(a)Following receipt of Marketing Approval for a Product in the Company Field in
any country in the Company Territory, Company shall use Commercially Reasonable
Efforts to Commercialize such Product in the Company Field in the Company
Territory; provided,  however, that in no event shall Company be obligated to
use Commercially Reasonable Efforts to Commercialize more than one Product in
any given country in the Company Territory.

(b)Following Company’s receipt of Marketing Approval for a Single Agent Product
for Monotherapy Use in any Indication in the Company Field in a country or
jurisdiction where such Single Agent Product has received Marketing Approval

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[***] 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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for Monotherapy Use in the TESARO Field during the Term, except for any country
or jurisdiction for which TESARO delivers a Monotherapy Registration &
Distribution Notice stating that TESARO will not Distribute the Single Agent
Product in the applicable country or jurisdiction, TESARO shall use Commercially
Reasonable Efforts to Distribute such Single Agent Product for such Monotherapy
Use in such Indication in the Company Field in such country or jurisdiction.

6.4Registration & Distribution Option. In the event that TESARO delivers a
Monotherapy Registration & Distribution Notice stating that TESARO will not
Distribute the Single Agent Product in the applicable country or jurisdiction,
then Company shall have the right to Distribute the applicable Single Agent
Product in the Company Field in such country or jurisdiction on the terms set
forth in this Section 6.4.  Company may exercise such right by providing written
notice of such exercise to TESARO within thirty (30) days following receipt of
such Monotherapy Registration & Distribution Notice and, upon exercise of such
right, the following terms shall apply with respect to the applicable Single
Agent Product and applicable country or jurisdiction:    

(a)Company shall be solely responsible for and have sole authority with respect
to all aspects of the Distribution of such Single Agent Product in the Company
Field in such country or jurisdiction.  Company shall prepare and maintain
complete and accurate written records and accounts with respect to such
Distribution activities conducted in conformity with Applicable Law and
Company’s standard practices, provided that in no case shall such records be
maintained for less than three (3) years following the Calendar Year to which
such records pertain (or any longer period required by Applicable Law).

(b)Company shall be solely responsible for all decisions regarding the Pricing
Terms for such Single Agent Product in the Company Field in such country or
jurisdiction, including negotiating and obtaining pricing and reimbursement
approvals with respect to such Single Agent Product in such country or
jurisdiction.  To the extent permitted by Applicable Law, the JCC shall review
and discuss decisions relating such Pricing Terms.

(c)Company shall purchase from TESARO, and TESARO will Manufacture and supply to
Company, Company’s requirements of such Single Agent Product for commercial sale
in the Company Field in such country or jurisdiction at Manufacturing Cost
[***].  The Parties shall negotiate in good faith and attempt to agree upon an
amendment to the API Supply Agreement or a separate supply agreement for the
supply of such Single Agent Product by TESARO to Company (and, if necessary, a
related quality agreement). 

(d)Upon TESARO’s written request at any time after Company’s exercise of its
right to Distribute such Single Agent Product in the Company Field in such
country or jurisdiction, Company shall transfer the responsibility for the
Distribution of such

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[***] 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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Single Agent Product in such country or jurisdiction to TESARO.  Such transfer
shall be conducted as soon as reasonably practicable following TESARO’s request
and shall be conducted in accordance with a transition plan to be mutually
agreed upon by the Parties.

6.5Trademarks; Product Packaging.     

(a)Company shall have sole responsibility, at its own expense, for all matters
relating to the use of, and shall own, all Trademarks used in the sale of
Combination Products in the Company Field in the Company Territory (the “Company
Trademarks”) (but excluding the TESARO Trademarks and any trademark that is
confusingly similar to a TESARO Trademark), including the selection, filing,
prosecution, maintenance, defense and enforcement thereof. 

(b)TESARO shall have sole responsibility, at its own expense, for all matters
relating to the use of, and shall own, all trademarks used in the sale of Single
Agent Products in any field in any territory and in the sale of Combination
Products in the sale of Combination Products in the TESARO Field in the TESARO
Territory (the “TESARO Trademarks”) (but excluding the Company Trademarks and
any trademark that is confusingly similar to a Company Trademark), including the
selection, filing, prosecution, maintenance, defense and enforcement thereof.

(c)To the extent permitted by Applicable Law: (i) on and after the first
Marketing Approval is obtained in a country in the Company Territory for a
Product in the Company Field, TESARO shall include Company’s name (or its local
Affiliate’s name) with equal prominence, or as close thereto as permitted by
Applicable Law, on all packaging and other materials related to such Product in
such country; and (ii) Company shall include TESARO’s name (or its local
Affiliate’s name) with equal prominence, or as close thereto as permitted by
Applicable Law, on all packaging and other materials related to any Combination
Product in each country in the Company Territory. 

6.6Transparency Reporting.  Company and TESARO shall each be responsible for
tracking and reporting transfers of value initiated and controlled by its and
its Affiliates’ employees, contractors, and agents pursuant to the requirements
of the marketing reporting laws or research expense reporting laws of any
Governmental Authority in the Company Territory, including Section 6002 of the
U.S. Patient Protection and Affordable Care Act of 2010, commonly referred to as
the “Sunshine Act.”

6.7Compliance with Law.   In performing Commercialization activities with
respect to the Compounds and Products, each Party will, and will cause its
Affiliates and Third Party subcontractors to, comply with Applicable Law and, to
the extent applicable to such Party’s Commercialization activities under this
Agreement, the other Party’s health care compliance policies and procedures and
any corporate integrity agreement to which the other Party is

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[***] 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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subject.  Each Party will provide the other Party with copies of any such health
care compliance policies and procedures and corporate integrity agreements.

6.8Advertising and Promotional Materials.  Each Party shall develop and approve
its own written sales, promotion and advertising materials relating to Products
(“Promotional Materials”) consistent with its standard operating procedures, for
use in the Company Territory by such Party.  All such Promotional Materials
shall be compliant with all Applicable Law and the provisions of the applicable
Regulatory Approvals.  Company shall provide to TESARO, for TESARO’s regulatory
compliance review and prior written approval according to procedures to be
agreed upon by the Parties through the JCC (including a reasonable period of
time in which such review must be completed, not to exceed five (5) days),
copies of all Promotional Materials relating to a Product that Company plans to
use in a country in which TESARO holds the Regulatory Approval for such
Product.  Company agrees that it shall not make use of such Promotional
Materials until it has received the prior related written approval of TESARO in
accordance with such procedures. 

6.9Subcontracting.  Each Party may subcontract the performance of any
Commercialization activities conducted by such Party in accordance with this
Agreement to any of its Affiliates or any Third Party, provided that (a) such
Party shall oversee the performance of any subcontracted activities in a manner
that would be reasonably expected to result in their successful and timely
completion and shall remain responsible for the performance of such
subcontracted activities in accordance with this Agreement[***].

6.10[***]. 

ARTICLE 7

MANUFACTURING

7.1Single Agent Products.    

(a)Clinical Supply.    

(i)TESARO shall have the sole responsibility for and sole authority with respect
to Manufacturing all Single Agent Products for use in Clinical Trials and other
Development activities to be conducted by Company in the Company Field in the
Company Territory.  TESARO shall bear all costs of such Manufacturing, subject
to the terms of this ARTICLE 7 and ARTICLE 8.

(ii)Promptly after the Effective Date, the Parties shall negotiate in good faith
and attempt to agree within [***] after the Effective Date upon a clinical
supply agreement (the “Clinical Supply Agreement”) for the supply of Single
Agent Products by TESARO to Company and a related quality agreement.  The
Clinical Supply Agreement shall include provisions regarding allocation of
Single Agent Products between Company and

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[***] 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 in the event of shortages.  Pursuant to the Clinical Supply Agreement,
TESARO shall supply the Single Agent Product labeled in final packaging unless
Company requests that Company applies the final packaging and labeling, at
TESARO’s Manufacturing Cost [***].  Pursuant to the Clinical Supply Agreement or
API Supply Agreement, TESARO shall also provide Company with Compound API for
Company’s CMC Development needs, such as for FDC development, at TESARO’s
Manufacturing Cost [***]. The related quality agreement with respect to the
Clinical Supply Agreement shall include provisions allowing Company to audit the
manufacturing sites (provided, that Company personnel are accompanied by TESARO
personnel), to request remediation of deficiencies that are required to be
remediated and to allow Company’s representatives to observe critical
manufacturing observations with respect to the Single Agent Products.

(iii)Between the Effective Date and the effective date of the Clinical Supply
Agreement, TESARO shall use reasonable efforts to Manufacture and supply to
Company Products for use in Clinical Trials and other Development activities to
be conducted by Company during that period as set forth on Exhibit 7.1(a). 

(b)Commercial Supply.  TESARO shall have the sole responsibility for and sole
authority with respect to Manufacturing all Single Agent Products for use and
sale by TESARO pursuant to Section 6.2(c) and by Company pursuant to Section 6.4
in the Company Field in the Company Territory.  TESARO shall bear all costs of
such Manufacturing, subject to the terms of this ARTICLE 7 and ARTICLE 8.

(c)Manufacturing Site Audits.  Promptly after the Effective Date (and in no
event more than thirty (30) days after the Effective Date), Company shall have
the right to request a prompt audit of all manufacturing sites where Products
and Compound API are manufactured by or for TESARO.  TESARO shall facilitate the
accommodation of such request; provided, that TESARO personnel shall accompany
any Company personnel conducting such audit.  Following the completion of such
audit, Company may request the remediation of deficiencies that are not in
compliance with GMP and identified by Company during such audit.  In the case of
any Critical Observation that TESARO or its contract manufacturer cannot or will
not remediate, Company will have the right to request the use of different
manufacturers for the supply of Product or Compound API for the Company’s
Clinical Trials. 

(d)CMC Development.  TESARO shall have the sole responsibility for and sole
authority with respect to CMC Development of all Single Agent Products at its
own cost.

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[***] 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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7.2Fixed Dose Combination Products. 

(a)Clinical and Commercial Supply.  Company shall have the sole responsibility
for and sole authority with respect to Manufacturing all Fixed Dose Combination
Products (i) for use in Clinical Trials and other Development activities to be
conducted by Company in the Company Field in the Company Territory and (ii) for
use and sale by Company in the Company Field in the Company Territory.  Company
shall bear all costs of such Manufacturing, subject to the terms of ARTICLE
8.  TESARO shall have the right to request and conduct an audit of all
manufacturing sites where all Fixed Dose Combination Products are manufactured
by or for Company only if, and to the extent that, TESARO has the right under
this Agreement to use such Fixed Dose Combination Products in a Clinical Trial
sponsored by TESARO or to sell such Fixed Dose Combination Products under its
trade name.  Company shall facilitate the accommodation of such request;
provided, that Company personnel shall accompany any TESARO personnel conducting
such audit.  Following the completion of such audit, TESARO may request the
remediation of deficiencies that are not in compliance with GMP and identified
by TESARO during such audit.  In the case of any Critical Observation that
Company or its contract manufacturer cannot or will not remediate, TESARO will
have the right to request the use of different manufacturers for the supply of
Fixed Dose Combination Products.

(b)CMC Development.  Company shall have the sole responsibility for and sole
authority with respect to CMC Development of all Fixed Dose Combination Products
at its own cost. 

7.3API Supply. 

(a)General.  Except as provided in this ARTICLE 7 or the API Supply Agreement,
TESARO shall have the sole responsibility for and sole authority with respect to
Manufacturing all Compounds for use as active pharmaceutical ingredients
(“Compound API”) in any Products to be Manufactured by either Party for use in
the Company Field in the Company Territory; provided,  however, that Company
shall have the right to Manufacture Compound API, or through its Affiliates or
Third Party contractors, for Company’s use in Manufacturing any FDCs Developed
by Company in the Company Field. 

(b)API Supply Agreement.  The Parties shall negotiate in good faith and attempt
to agree within [***] after the Effective Date upon a supply agreement for the
supply of Compound API by TESARO to Company at TESARO’s Manufacturing Cost [***]
(except API supplied for Company’s CMC or clinical Development and technology
transfer needs will be at TESARO’s Manufacturing Cost [***]) (the “API Supply
Agreement”) and a related quality agreement.  The API Supply Agreement shall
include: (i) technology transfer obligations of TESARO and

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[***] 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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Technology Transfer Costs to be paid by Company, its Affiliates and Third Party
contractors; and (ii) provisions regarding allocation of Compound API between
Company and TESARO in the event of shortages, which shall be consistent with
Section 7.7 unless otherwise agreed by the Parties.  Additionally, the Parties
may agree that Company or its Affiliates (directly or indirectly through a Third
Party) shall serve as a second source supplier of Single Agent Products or
Compound API for use in the Manufacture of Single Agent Products, in which case
TESARO would have audit rights with respect to all manufacturing sites where
Compound API is manufactured for use in Single Agent Products used in Clinical
Trials sponsored by TESARO or sold by TESARO under its trade name.

(c)Interim API Supply.  Between the Effective Date and the effective date of the
API Supply Agreement, TESARO shall use reasonable efforts to Manufacture and
supply to Company all of Company’s requirements of Compound API for use (i) in
CMC Development activities of Company conducted pursuant to this ARTICLE 7 and
(ii) in Manufacturing by Company of Fixed Dose Combination Products for use in
Clinical Trials conducted by Company pursuant to this Agreement, as set forth on
Exhibit 7.1(a). 

(d)Guaranteed Volume of Compound API and Clinical Supply.  TESARO shall, at a
minimum, Manufacture and supply to Company [***] of its requirements of Single
Agent Product for Company’s planned Phase 1 Clinical Trial, [***] of its
requirements of Single Agent Product for the run-in phase of Company’s planned
Phase 2 Clinical Trial, [***] of its requirements of Single Agent Product for
the Registration Phase Trial for Monotherapy Use and [***] of its requirements
of Single Agent Product for Company’s planned Phase 2 and Phase 3 Clinical
Trials for Combination Use, as such requirements are set forth on Exhibit
7.1(a).  TESARO shall use reasonable efforts to provide all such supplies no
later than [***] prior to the anticipated date of dosing of the first patient in
the applicable Clinical Trial. 

7.4Joint Manufacturing Committee.    

(a)Formation and Purpose.  The Parties agree to establish and convene the JMC
within thirty (30) days after the Effective Date.  The JMC shall consist of
representatives from each Party as further described in Section 2.6(a) and
operate in accordance with this Section 7.4 and Section 2.6.  The purpose of the
JMC shall be to serve as a forum for the Parties to discuss and share
information regarding the Manufacture and CMC Development of the Products and
Compound API, and to determine, approve or resolve only those matters with
respect to such Manufacture and CMC Development that the JMC is expressly
authorized to determine, approve or resolve, pursuant to this ARTICLE
7.   Neither Party’s Manufacturing and CMC Development activities and decisions
require the approval, consent or agreement of the JMC, JSC, any other Joint

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[***] 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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Committee, subcommittee, or the other Party except as expressly provided in this
Agreement, the Clinical Supply Agreement or the API Supply Agreement.

(b)Responsibilities of the JMC.  The JMC shall: 

(i)review and discuss annual capacity planning and supply continuity plans for
the Single Agent Products and Compound API, including allocation of Single Agent
Products and Compound API in the event of shortages and the possibility of
Company or its Affiliates (directly or indirectly through a Third Party) serving
as a second supplier of Single Agent Products or Compound API for us in the
Manufacture of Single Agent Products;

(ii)consult with the JDC regarding clinical supply manufacturing;

(iii)review and discuss potential changes in Third Party suppliers and
subcontractors, including the potential benefits to the Parties of Company’s
participation in TESARO’s contract negotiations with such Third Parties; and

(iv)perform other obligations specifically delegated to it and permitted under
this Agreement.

(c)JMC Decisions and Actions.  The JMC shall not have any formal decision-making
authority, except with respect to the following matters:

(i)The JMC shall discuss and approve an allocation mechanism in the event of
anticipated or actual shortages of Single Agent Products or Compound API in
accordance with Section 7.7. 

(ii)If the JMC does not reach unanimous agreement with respect to the existence
of an anticipated or actual shortage of Single Agent Products or Compound API
within thirty (30) Business Days from the date that the matter is first
presented to the JMC, such matter will be a Deadlocked Committee Matter.  Either
Party may refer such matter to the JSC for attempted resolution pursuant to the
Escalation Procedures.  If the matter is not resolved pursuant to the Escalation
Procedures, TESARO shall have final decision-making authority with respect to
such Deadlocked Committee Matter. 

(iii)If the JMC reaches unanimous agreement with respect to the existence of an
anticipated or actual shortage of Single Agent Products or Compound API but does
not reach unanimous agreement with respect to such allocation mechanism within
thirty (30) Business Days from the date that the matter is first presented to
the JMC, such matter shall be resolved in accordance with Section 7.7.

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[***] 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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Actions to be taken and decisions to be made by the JMC with respect to such
matters shall be taken or made by unanimous agreement, with each Party’s JMC
representatives collectively having one (1) vote. 

7.5Compliance with Law.  The Parties will, and will cause their Affiliates and
Third Party subcontractors and (sub)licensees to, comply with Applicable Law in
performing Manufacturing activities with respect to the Compounds and Products,
including GMP.

7.6Subcontracting; Audit Rights.  Each Party may subcontract the performance of
any Manufacturing or CMC Development activities conducted in accordance with
this Agreement to any of its Affiliates or any Third Party, provided that such
Party shall oversee the performance of any subcontracted activities in a manner
that would be reasonably expected to result in their successful and timely
completion and shall remain responsible for the performance of such
subcontracted activities in accordance with this Agreement.  Company shall have
the right to audit the performance of any Third Party suppliers, contractors and
subcontractors used by TESARO in the Manufacturing of Single Agent Products,
Compound API or Fixed Dose Combination Products, as applicable, for use by
either Party in the Company Field in accordance with this Agreement.  TESARO
shall have the right to audit the performance of any Third Party suppliers,
contractors and subcontractors used by Company in the Manufacturing of Single
Agent Products, Compound API or Fixed Dose Combination Products, as applicable,
for use by TESARO only if, and to the extent that, TESARO has the right under
this Agreement to use such Single Agent Products or Fixed Dose Combination
Products in a Clinical Trial sponsored by TESARO, to sell such Single Agent
Products or Fixed Dose Combination Products under its trade name or to use such
Compound API in the Manufacturing of Single Agent Products for such use or
sale.  The terms of such audit rights will be negotiated by the Parties in good
faith and set forth in the quality agreements described in this ARTICLE 7 (with
respect to Single Agent Product clinical supply and Compound API supply) and in
separate quality agreements, but in any event such terms shall include the
following: (a) following the completion of an audit, a Party may request the
remediation of deficiencies identified by the other Party during such audit and
any Critical Observations shall be remediated by the applicable Third Party
supplier, contractor or subcontractor; (b) in the event that the applicable
Third Party supplier, contractor or subcontractor cannot or will not agree to
remediate a Critical Observation (as determined under Applicable Law) identified
during an audit, the auditing Party will have the right to request that the
other Party engage a different Third Party supplier, contractor or subcontractor
with respect to any Manufacturing or CMC Development activities conducted in
accordance with this Agreement; and (c) the auditing Party shall be permitted to
observe key manufacturing events during the Manufacturing process.

7.7Supply Shortages.  In the event TESARO becomes aware of anticipated or actual
shortages of Single Agent Products or Compound API, TESARO shall [***] notify
Company of such shortage.  In the event Company reasonably believes that there
is an anticipated or actual shortage of Single Agent Products or Compound API,
Company shall notify TESARO of such belief.  Subject to Section 7.4(c), after
either Party gives such notice to the other Party, the JMC shall meet promptly
thereafter to (x) determine whether an anticipated or actual shortage exists

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[***] 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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and (y) if so, agree upon a mechanism for allocating between the Parties the
available quantities of Single Agent Product or Compound API, as applicable
(including any Compound API being Manufactured by Company).  If the JMC does not
agree upon an allocation mechanism within thirty (30) Business Days from the
date that Company is notified of such shortage, then the available quantities of
Single Agent Product or Compound API, as applicable, shall be allocated in
accordance with the following principles: [***]. If the JMC does not reach
unanimous agreement on an allocation mechanism within thirty (30) Business Days
from the date that Company is notified of such shortage and the JMC does not
reach unanimous agreement on a specific allocation mechanism consistent with the
foregoing allocation principles within ten (10) Business Days of such thirtieth
(30th) Business Day, such matter will be a Deadlocked Committee Matter.  Either
Party may refer such matter to the JSC for attempted resolution pursuant to the
Escalation Procedures.  If the matter is not resolved pursuant to the Escalation
Procedures, [***].  Notwithstanding the foregoing or anything else in this
Agreement to the contrary, in the event of an actual shortage of Single Agent
Products or Compound API, during the pendency of any Escalation Procedure
initiated under this Section 7.7, to the extent necessary, TESARO may implement
an allocation procedure consistent with the allocation principles set forth in
this Section 7.7.

ARTICLE 8

CONSIDERATION

8.1Upfront Payment.   On or after the Effective Date, TESARO shall submit an
invoice to Company for Thirty-Five Million Dollars ($35,000,000) as a one-time,
non-refundable, non-creditable upfront payment.   Such invoice shall be due and
payable within [***] after receipt by Company.  

8.2Milestone Payments.  Company will notify TESARO within [***] following the
achievement by Company, its Affiliate or sublicensee of each Development
Milestone, each Regulatory Milestone and each Sales Milestone as applicable
(collectively, the “Milestone Events”).  Within [***] after such achievement of
each such Milestone Event, Company shall remit the applicable Development
Milestone Payment, Regulatory Milestone Payment or Sales Milestone Payment
(collectively, the “Milestone Payments”) to TESARO.  Each Milestone Payment by
Company pursuant to this Section 8.2 shall be payable only once.

(a)Development Milestones.    The following payments (each, a “Development
Milestone Payment”) shall be made on a one-time basis with respect to the first
Product to achieve the corresponding milestone event (each, a “Development
Milestone”): 

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[***] 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 Milestone

Development
Milestone Payment
(USD)

1.[***]

$[***]

2.[***]

$[***]

3.[***]

$[***]

4.[***]

$[***]

 

[***].  Additionally, each Development Milestone Payment may be earned upon the
achievement of an alternative Development Milestone in accordance with Section
4.3(b).

(b)Regulatory Milestones.  The following payments (each, a “Regulatory Milestone
Payment”) shall be made on a one-time basis with respect to the first Product to
achieve the corresponding milestone event (each, a “Regulatory Milestone”):    
   

 

 

 

Regulatory Milestone

Regulatory Milestone Payment (USD)

 

FDA

EMA

1.[***]

$[***]

$[***]

2.[***]

$[***]

$[***]

3.[***]

$[***]

$[***]

4.[***]

$[***]

$[***]

5.[***]

$[***]

$[***]

6.[***]

$[***]

$[***]

 

(c)Sales Milestones.  The following payments (each, a “Sales Milestone Payment”)
shall each be payable to TESARO one-time only, upon the first time during the
Term that the annual Territory-Wide Prostate Net Sales of Products in the
Company Territory in any Calendar Year during the applicable Royalty Terms for
such Products exceed the amounts set forth in the following table (each, a
“Sales Milestone”):

Annual Territory-Wide Prostate Net Sales Milestones

Sales Milestone

Sales Milestone
Payment (USD)

Upon the first occasion that annual Territory-Wide Prostate Net Sales of
Products in the Company Territory in a Calendar Year exceeds $[***]

$[***]

Upon the first occasion that annual Territory-Wide Prostate Net Sales of
Products in the Company Territory in a Calendar Year exceeds $[***]

$[***]

Upon the first occasion that annual Territory-Wide Prostate Net Sales of
Products in the Company Territory in a Calendar Year exceeds $[***]

$[***]

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[***] 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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If more than one Sales Milestone described in this Section 8.2(c) is achieved
during the same Calendar Year, Company shall pay TESARO each Sales Milestone
Payment that corresponds to such Sales Milestones.  For purposes of clarity,
only one Sales Milestone Payment shall be owed on the first occasion that annual
Territory-Wide Prostate Net Sales of Products in the Company Territory in a
Calendar Year exceeds $[***], $[***] or $[***]. 

(d)Merck Milestones.  The Parties acknowledge that TESARO shall be responsible
for making any milestone payments that become payable under the Merck License
Agreement with respect to Company’s activities hereunder.  Notwithstanding the
foregoing, if [***] any of the development milestones set forth on Exhibit
8.2(d) (each, a “Merck Milestone”) are attained [***] and (2) the corresponding
milestone payment set forth on Exhibit 8.2(d) becomes payable by TESARO to Merck
pursuant to Section 7.02 of the Merck Agreement (each, a “Merck Milestone
Payment”), then [***].

8.3Single Agent Alliance Payments.

(a)General.  TESARO shall pay to Company certain other amounts (“Alliance
Payments”) for all Prostate-Approved Single Agent Products that are sold at any
time during the Term by or on behalf of TESARO, its Affiliates, licensees (other
than Company) or sublicensees in the Company Territory calculated in accordance
with Exhibit 8.3 and paid quarterly as set forth below in this Section 8.3.

(b)Reports. 

(i)Within [***] after the end of each TESARO Calendar Quarter, TESARO shall
perform the calculations described in Exhibit 8.3, and prepare and deliver to
Company the Alliance Payments Report described in Exhibit 8.3.   Each Alliance
Payments Report shall be the Confidential Information of each Party.  Procedures
for quarterly reporting of actual results, and review and discussion of
potential discrepancies, quarterly reconciliation, reasonable forecasting, and
other finance and accounting matters, to the extent not set forth in Exhibit
8.3, will be established by the JFC.  Such procedures will provide the ability
to comply with financial reporting requirements of each Party.  Such report
shall also include the

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[***] 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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exchange rates and other methodology used in converting Net Sales into U.S.
Dollars from the currencies in which such sales were made.  In addition, the
report shall provide a reasonable allocation of the information contained
therein between U.S. and non-U.S. activity (including any TESARO Incremental
Royalties or Pass-through Third Party Royalty amounts due with respect to TESARO
Prostate-Approved Single Agent Product Net Sales).

(ii)Within [***] after the end of each Calendar Quarter (except, with respect to
the fourth Calendar Quarter of a Calendar Year, within [***] after the end of
such Calendar Quarter) (or, if Company Parent delivers a public earnings report
within any such [***] period, within three (3) calendar days following the
delivery of such earnings report, if later), the Company shall provide to TESARO
a report of total Company Prostate-Approved Single Agent Product Net Sales and
Company Combination Product Net Sales for the Calendar Quarter.  In the event
that Company Parent determines that it will deliver its public earnings report
later than [***] after the end of a Calendar Quarter, Company shall promptly
notify TESARO and the Parties shall mutually agree upon a reasonable extension
to the deadline for the delivery of the report described in this Section
8.3(b)(ii), provided that such extension shall take into account TESARO’s
obligation to deliver royalty reports to Merck within forty-five (45) days
following the end of each TESARO Calendar Quarter.

(c)Payment of Alliance Payments.  Following receipt of an Alliance Payments
Report, (i) if the Alliance Payments set forth therein are greater than [***],
Company shall invoice TESARO for the Alliance Payments set forth therein, and
TESARO shall pay such invoice, within [***] after receipt in accordance with
Section 8.14 and (ii) if the Alliance Payments are less than [***], TESARO shall
invoice Company for the Alliance Payments set forth therein, and Company shall
pay such invoice, within [***] after receipt in accordance with Section
8.14.  Notwithstanding the foregoing, if Company initiates an investigation
following receipt of an Alliance Payments Report in accordance with Section
8.3(d), then the due date for paying such invoice shall be extended by the
longer of (i) [***] and (ii) the number of days it takes to complete the
investigation. 

(d)Errors in Alliance Payments Reports.  If Company reasonably believes that
there is an error in an Alliance Payments Report (or the calculations underlying
such Alliance Payments Report), Company shall so notify TESARO within [***of
receipt of such Alliance Payments Report.  The Parties shall meet promptly after
such notice is given to investigate the potential error.  If such investigation
confirms or reveals an error, TESARO shall correct and re-issue the Alliance
Payments Report within [***].  If Company has already issued an invoice to
TESARO with respect to the applicable TESARO Calendar Quarter, then

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[***] 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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promptly following receipt of such re-issued Alliance Payments Report, Company
shall issue an invoice or a credit note, as applicable, equal to the amount of
the difference between the Alliance Payments set forth in the re-issued report
and the Alliance Payments set forth in Company’s original invoice for such
TESARO Calendar Quarter and, if applicable, TESARO shall pay such invoice in
accordance with Section 8.3(c).  If Company has not yet issued an invoice to
TESARO with respect to the applicable TESARO Calendar Quarter, then Company
shall use the re-issued Alliance Payments Report to prepare the invoice for such
Calendar Quarter in accordance with Section 8.3(c).

(e)Alliance Payments Forecasts.  For each TESARO Calendar Year, TESARO shall
prepare and deliver to Company a forecast for the next TESARO Calendar Year
containing a good faith estimate of the Alliance Payments, including all
deductions, for each TESARO Calendar Quarter (the “Annual Alliance Payment
Forecast”).  The timing of such Annual Alliance Payment Forecast shall be agreed
to by the JFC.  Each Annual Alliance Payment Forecast shall be the Confidential
Information of each Party.  The JFC may agree upon additional information to be
included in each Annual Alliance Payment Forecast.  The Parties shall also
develop, through the JFC, a process to agree upon the estimated Alliance
Payments for a TESARO Calendar Quarter before the close of such TESARO Calendar
Quarter. 

8.4Company Royalty Obligations.    

(a)Definitions.  For purposes of this Agreement, the following terms shall have
the following meanings: 

(i)“Combined Worldwide Prostate-Approved Single Agent Product Net Sales” means,
with respect to any Prostate-Approved Single Agent Product sold by either Party
or any of its Affiliates or (sub)licensees in the Company Territory in a
particular TESARO Calendar Quarter or Calendar Quarter, respectively, the sum
of: (A) the total TESARO Prostate-Approved Single Agent Product Net Sales for
such Prostate-Approved Single Agent Product in all countries in the Company
Territory during the corresponding TESARO Calendar Quarter; (B) the total TESARO
Net Sales of such Prostate-Approved Single Agent Product in the TESARO Field in
all countries in the TESARO Territory during the corresponding TESARO Calendar
Quarter; and (C) the total Company Prostate-Approved Single Agent Product Net
Sales for such Prostate-Approved Single Agent Product in the Company Field all
countries in the Company Territory during such Calendar Quarter.

(ii)“Company Combination Product Net Sales” means, with respect to any
Combination Product sold by Company or any of its Affiliates or

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[***] 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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(sub)licensees in any country in the Company Territory in a particular Calendar
Quarter, the total Net Sales of such Combination Product by Company or any of
its Affiliates or sublicensees in such country during such Calendar Quarter. 

(iii)“Company Prostate-Approved Single Agent Product Net Sales” means, with
respect to a Prostate-Approved Single Agent Product sold by Company or any of
its Affiliates or (sub)licensees in a country in the Company Territory in a
particular Calendar Quarter pursuant to Section 6.4, the total Net Sales of such
Prostate-Approved Single Agent Product by Company or its Affiliates or
(sub)licensees in such country during such Calendar Quarter. 

(iv)“Prostate-Approved Single Agent Product” means, with respect to a country in
the Company Territory, any Single Agent Product: (A) that has received Marketing
Approval (which, for purposes of this definition, means Marketing Approval as
defined in Section 1.79 but without respect to the pricing and reimbursement
approvals referred to in clause (b) of Section1.79); (B) if such country is the
U.S., the use of which for an Indication in the Company Field is included, or
approved for inclusion, in a compendium recognized by the Centers for Medicare &
Medicaid Services; or (C) that has been distributed for an Indication in the
Company Field as part of an early access program operated by either Party in
such country on a named patient basis or early access clinical trial basis. 

(v)“Prostate-Approved Single Agent Product Net Sales” means, with respect to any
Prostate-Approved Single Agent Product in a country in the Company Territory in
a particular TESARO Calendar Quarter or Calendar Quarter, respectively, the
amount equal to both: (A) if TESARO or its Affiliates, licensees (other than
Company) or sublicensees sold such Prostate-Approved Single Agent Product in
such country during such TESARO Calendar Quarter, the TESARO Prostate-Approved
Single Agent Product Net Sales with respect to such Prostate-Approved Single
Agent Product in such country during the corresponding TESARO Calendar Quarter;
and (B) if Company or any of its Affiliates or sublicensees sold such
Prostate-Approved Single Agent Product in such country during such Calendar
Quarter in accordance with Section 6.4, the Company Prostate-Approved Single
Agent Product Net Sales in such country during such Calendar Quarter. 

(vi)“Territory-Wide Company Combination Product Net Sales” means, with respect
to any Combination Product sold by Company or any of its Affiliates or
(sub)licensees in the Company Territory in a particular Calendar Quarter, the
total Company Combination Product Net Sales for

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[***] 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 Combination Product in all countries in the Company Territory during such
Calendar Quarter. 

(vii)“Territory-Wide Prostate Net Sales” means, with respect to a particular
Calendar Quarter, the amount equal to the sum of (A) the TESARO
Prostate-Approved Single Agent Product Net Sales for all Prostate-Approved
Single Agent Products sold by TESARO or any of its Affiliates or (sub)licensees
in the Company Territory during such TESARO Calendar Quarter; (B) the Company
Prostate-Approved Single Agent Product Net Sales for all Prostate-Approved
Single Agent Products sold by Company or any of its Affiliates or (sub)licensees
in the Company Territory during such Calendar Quarter pursuant to Section 6.4;
and (C) the Territory-Wide Company Combination Product Net Sales for all
Combination Products sold by Company or any of its Affiliates or (sub)licensees
in the Company Territory during such Calendar Quarter. 

(viii)“TESARO Prostate-Approved Single Agent Product Net Sales” means, with
respect to a Prostate-Approved Single Agent Product sold by TESARO or any of its
Affiliates or (sub)licensees (other than Company) in a country in the Company
Territory in a particular TESARO Calendar Quarter, the total Net Sales of such
Prostate-Approved Single Agent Product attributable to use in the Company Field,
as determined under and further defined in Exhibit 8.3 (including any prior
Calendar Quarter adjustments made pursuant to Exhibit 8.3). 

(b)Royalty Rates.

(i)Pass-through Third Party Royalties. 

(1)Merck.  In the event that royalties are payable by TESARO to Merck with
respect to any Prostate-Approved Single Agent Product Net Sales or Company
Combination Product Net Sales under the Merck License Agreement, Company shall
pay to TESARO royalties on a Product-by-Product basis at the rates set forth in
the following table (the “Pass-through Merck Royalty”) with respect to (A)
Prostate-Approved Single Agent Product Net Sales of each Prostate-Approved
Single Agent Product in each country in the Company Territory during the Merck
Royalty Term for such Single Agent Product and (B) Company Combination Product
Net Sales of each Combination Product in each country in the Company Territory
during the Merck Royalty Term for such Combination Product in such country, in
each case ((A) and (B)), calculated in accordance with the terms set forth on
Exhibit

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[***] 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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8.4(b)(i)(1) and either deducted or paid as set forth in Section 8.7(a):   

 

 

 

Name of Merck
Royalty Tier

Combined Worldwide Prostate-Approved
Single Agent Product Net Sales or Territory-
Wide Company Combination Product Net Sales
in a Calendar Year (on a Product by Product
basis)

Pass-through Merck
Royalty Rate

Tier 1

On the portion of Combined Worldwide Prostate-Approved Single Agent Product Net
Sales of the relevant Product or Territory-Wide Company Combination Product Net
Sales of the relevant Product, as applicable, in a Calendar Year less than or
equal to $[***]

[***]%

Tier 2

On the portion of Combined Worldwide Prostate-Approved Single Agent Product Net
Sales of the relevant Product or Territory-Wide Company Combination Product Net
Sales of the relevant Product, as applicable, in a Calendar Year greater than
$[***] and less than or equal to $[***]

[***]%

Tier 3

On the portion of Combined Worldwide Prostate-Approved Single Agent Product Net
Sales of the relevant Product or Territory-Wide Company Combination Product Net
Sales of the relevant Product, as applicable, in a Calendar Year greater than
$[***]

[***]%

 

For clarity, the amount of the Pass-through Merck Royalty for a given
Prostate-Approved Single Agent Product is calculated by multiplying the
applicable Pass-through Merck Royalty Rate by the Prostate-Approved Single Agent
Product Net Sales of such Product, not by the Combined Worldwide
Prostate-Approved Single Agent Product Net Sales of such Product.

 

(2)AstraZeneca.  In the event that royalties are payable by TESARO to
AstraZeneca with respect to any Prostate-Approved Single Agent Product Net Sales
or Company Combination Product Net Sales under either of the AstraZeneca License
Agreements, Company shall pay to TESARO, on a Product-by-Product basis: (A) a
royalty of [***] (the “Pass-through AstraZeneca-ICR Royalty”) with respect to
(i) Prostate-Approved Single Agent Product Net Sales for each Prostate-Approved
Single Agent Product in each country in the Company Territory during the
AstraZeneca-ICR Royalty Term for such Single Agent Product in such country and
(ii) Company Combination Product Net Sales of

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[***] 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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each Combination Product in each country in the Company Territory during the
AstraZeneca-ICR Royalty Term for such Combination Product in such country; and
(B) a royalty of [***] (the “Pass-through AstraZeneca-Sheffield Royalty”) with
respect to (i) Prostate-Approved Single Agent Product Net Sales for each
Prostate-Approved Single Agent Product in each country in the Company Territory
during the AstraZeneca-Sheffield Royalty Term for such Single Agent Product in
such country and (ii) Company Combination Product Net Sales of each Combination
Product in each country in the Company Territory during the
AstraZeneca-Sheffield Royalty Term for such Combination Product in such country,
in each case ((A) and (B)), in accordance with the terms set forth on Exhibit
8.4(b)(i)(2) and either deducted or paid as set forth in Section 8.7(a).

(ii)TESARO Incremental Royalties.  Company shall pay to TESARO royalties at the
rates set forth in the following table (the “TESARO Incremental Royalty”) with
respect to (A) Prostate-Approved Single Agent Product Net Sales of each Single
Agent Product in each country in the Company Territory during the Royalty Term
for such Single Agent Product and (B) Company Combination Product Net Sales of
each Combination Product in each country in the Company Territory during the
Royalty Term for such Combination Product in such country, in each case ((A) and
(B)), calculated in accordance with the terms set forth in Sections 8.4(d), 8.5
and 8.6 and either deducted or paid as set forth in Section 8.7(a):    

Name of TESARO
Royalty Tier

Territory-Wide Prostate Net Sales
in a
Calendar Year

TESARO
Incremental
Royalty Rate

Tier 1

On the portion of Territory-Wide Prostate Net Sales, in a Calendar Year less
than or equal to $[***]

[***]%

Tier 2

On the portion of Territory-Wide Prostate Net Sales, in a Calendar Year greater
than $[***] and less than or equal to $[***]

[***]%

Tier 3

On the portion of Territory-Wide Prostate Net Sales, in a Calendar Year greater
than $[***]

[***]%

 

(c)Annual Royalty Payment Forecasts.  For each Calendar Year, each Party shall
prepare and deliver to the other Party a forecast for the next Calendar Year
containing: (i) in Company’s forecast, a good faith estimate of the total
Prostate-Approved Single Agent Product Net Sales in all countries in the Company
Territory during such Calendar Year; and (ii) in TESARO’s forecast, the
forecasted Pass-through Merck Royalty Rate(s) (and, if applicable, the
forecasted

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[***] 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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Effective Merck Royalty Rate(s) determined in accordance with in Exhibit
8.4(b)(i)(1)) for each TESARO Calendar Quarter of the TESARO Calendar Year that
corresponds to such Calendar Year (the “Annual Royalty Payment Forecast”).  The
timing of such Annual Royalty Payment Forecast shall be agreed to by the
JFC.  Each Annual Royalty Payment Forecast shall be the Confidential Information
of each Party.  The JFC may agree upon additional information to be included in
each Annual Royalty Payment Forecast.

(d)No Multiple Royalties.  For each Net Sale of a Prostate-Approved Single Agent
Product or Combination Product, the Company shall be obligated to pay no more
than one Pass-through Merck Royalty, one Pass-through AstraZeneca-ICR Royalty,
one Pass-through AstraZeneca-Sheffield Royalty and one TESARO Incremental
Royalty under Section 8.3 and this Section 8.4.

8.5Royalty Term.     The TESARO Incremental Royalty under Section 8.4(b)(ii)
with respect to Prostate-Approved Single Agent Product Net Sales or Company
Combination Product Net Sales, as applicable, shall be payable on a
country-by-country basis during the applicable Royalty Term with respect to such
Product in such country.  Following the expiration of the Royalty Term with
respect to a Product in a country of the Company Territory, subject to the terms
and conditions of this Agreement, Company shall have a perpetual, irrevocable,
non-exclusive, fully paid-up and royalty-free right and license, with the right
to grant sublicenses without restriction, under the TESARO Technology and TESARO
Trademarks to Exploit such Product in the Company Field in such country of the
Company Territory.    

8.6Royalty Rate Reduction.   The TESARO Incremental Royalty Rates shall be
reduced (a) by [***], on a country-by-country basis and Product-by-Product
basis, in each country in which, at any given time, no Valid Claim of a TESARO
Patent Covers  the applicable Product in such country and (b) by [***], on a
country-by-country basis and Product-by-Product basis, in each country in which,
at any given time, there is competition for the applicable Product in such
country from a Generic Version of such Product.  With respect to the Fixed Dose
Combination Product or another Combination Product, the reduction to the royalty
set forth in Section 8.6(b) shall apply only when there is a Generic Version of
the entire Product (i.e., all active pharmaceutical ingredients within such
Product are approved as a Generic Version and a Generic Version of the Product
itself has been approved).

8.7Manner of Royalty Payment.  

(a)Pass-through Merck Royalty, Pass-through AstraZeneca-ICR Royalty,
Pass-through AstraZeneca-Sheffield Royalty and TESARO Incremental Royalty
amounts due with respect to TESARO Prostate-Approved Single Agent Product Net
Sales will be deducted by TESARO when calculating the Alliance Payments due to
Company, as set forth on Exhibit 8.3, and will not be payable by Company to
TESARO pursuant to this Section 8.7.  Pass-through Merck Royalty, Pass-through
AstraZeneca-ICR Royalty, Pass-through AstraZeneca-Sheffield Royalty

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[***] 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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and TESARO Incremental Royalty amounts due with respect to Company
Prostate-Approved Single Agent Product Net Sales and Company Combination Product
Net Sales will be payable by Company to TESARO pursuant to this Section 8.7.

(b)Within [***] following the end of each Calendar Quarter after the
commencement of the Royalty Term for a Product in the Company Territory (or, if
such Calendar Quarter is the fourth Calendar Quarter of a Calendar Year, the
later of (1) [***] following the end of such Calendar Quarter or (2) [***] after
the Merck Royalty Rate or Effective Merck Royalty Rate is reported by TESARO to
Company pursuant to Exhibit 8.4(b)(i)(1)), Company shall provide TESARO with a
report (a “Royalty Payment Report”) setting forth, on a Product-by-Product and
country-by-country basis: (i) Company Prostate-Approved Single Agent Product Net
Sales for each Prostate-Approved Single Agent Product and Company Combination
Product Net Sales for each Combination Product in such country; (ii) the
applicable Pass-through Merck Royalty, Pass-through AstraZeneca-ICR Royalty,
Pass-through AstraZeneca-Sheffield Royalty and TESARO Incremental Royalty with
respect to such Net Sales; and (iii) the total royalty amount due with respect
to such Net Sales.  Such report shall also include: (A) the gross sales of each
Product on a country-by-country basis, (B) with respect to the U.S., to the
extent available within the Company’s Records a reasonably detailed statement of
any deductions taken from Company Prostate-Approved Single Agent Product Net
Sales or Company Combination Product Net Sales taken from such gross sales to
arrive at Company Prostate-Approved Single Agent Product Net Sales or Company
Combination Product Net Sales, as applicable, for the applicable Calendar
Quarter, (C) with respect to countries other than the U.S., the aggregate amount
of deductions taken from Company Prostate-Approved Single Agent Product Net
Sales or Company Combination Product Net Sales taken from such gross sales to
arrive at Company Prostate-Approved Single Agent Product Net Sales or Company
Combination Product Net Sales, as applicable, in such country for the applicable
Calendar Quarter, (iv) the exchange rates and other methodology used in
converting Net Sales into U.S. Dollars from the currencies in which such sales
were made for purposes of calculating the appropriate royalty rate and the
royalty payment due, and (v) the application of the reductions, if any, made in
accordance with the terms of Section 8.6 or Section 8.9.  Company shall pay all
amounts due to TESARO pursuant to Section 8.4 with respect to Company
Prostate-Approved Single Agent Product Net Sales and Company Combination Product
Net Sales for such Calendar Quarter in U.S. Dollars at the time the submission
of such quarterly report is due.

(c)If TESARO reasonably believes that there is an error in a Royalty Payment
Report (or the calculations underlying such Royalty Payment Report), TESARO
shall so notify Company within [***] of receipt of such Royalty Payment
Report.  The Parties shall meet promptly after such notice is given to
investigate the

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[***] 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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potential error.  If such investigation confirms or reveals an error, Company
shall correct and re-issue the Royalty Payment Report within [***].  If TESARO
has already issued an invoice to Company with respect to the applicable Calendar
Quarter, then promptly following receipt of such re-issued Royalty Payment
Report, TESARO shall issue an invoice or a credit note, as applicable, equal to
the amount of the difference between the royalty payment due as set forth in the
re-issued report and the royalty payment due as set forth in TESARO’s original
invoice for such Calendar Quarter and, if applicable, Company shall pay such
invoice in accordance within [***] after receipt.  If TESARO has not yet issued
an invoice to Company with respect to the applicable Calendar Quarter, then
TESARO shall use the re-issued Royalty Payment Report to prepare the invoice for
such Calendar Quarter in accordance with this Section 8.7.

8.8Currency.  

(a)All payments under this Agreement shall be payable in U.S. Dollars. 

(b)For the Company, with respect to sales of a Product invoiced in a currency
other than U.S. Dollars, such amounts and the amounts payable hereunder shall be
expressed in their U.S. Dollars equivalent calculated using the Currency Hedge
Rates.  For each Calendar Year during which royalties become due under Section
8.4, Company shall provide TESARO the Currency Hedge Rate to be used for the
local currency of each country in the Company Territory in which any
royalty-bearing Net Sales are expected to occur, in writing no later than [***]
after the Currency Hedge Rate(s) are available [***], which is customarily
[***].  Each Currency Hedge Rate will remain constant throughout the upcoming
Calendar Year.  Company shall use the Currency Hedge Rate(s) to convert Net
Sales to U.S. Dollars for the purpose of calculating royalty payments hereunder.
 

(c)For TESARO, in the case of sales outside the U.S., payments received and
payments to be made by TESARO will be expressed in the U.S. Dollar equivalent
calculated on a TESARO Calendar Quarterly basis in the currency of the country
of sale and converted to their U.S. Dollar equivalent using the average rate of
exchange over the applicable TESARO Calendar Quarter to which the sales relate,
in accordance with GAAP and the then current standard methods of TESARO, to the
extent reasonable and consistently applied; provided,  however, that if, at such
time, TESARO does not use a rate for converting into U.S. Dollar equivalents
that is maintained in accordance with GAAP, then TESARO shall use a rate of
exchange which corresponds to the official market closing rate of exchange for
such currency reported by the Wall Street Journal as of the last day of the
applicable reporting period (or, if unavailable on such date, the first date
thereafter on which such rate is available).  TESARO will inform Company as to
the specific exchange rate translation methodology used for a particular country
or countries. 

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[***] 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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8.9Third Party Financial Obligations.

(a)Obligations under TESARO License Agreements.    TESARO shall be solely
responsible for the payment of any royalties, sublicense revenues, milestones or
other payments that become due under the TESARO License Agreements as a result
of the Exploitation of the Compounds and Products in the Company Field in the
Company Territory or in the TESARO Field in the TESARO Territory.  Company shall
notify TESARO in writing within [***] after the achievement of any of the
milestone events set forth on Exhibit 8.2(d).

(b)Future License Agreements.  If, during the Term, either Party determines, in
its reasonable judgment, that it is necessary to obtain a license or other
rights under any Patent or other intellectual property owned or controlled by a
Third Party in order to Exploit (A) a Single Agent Product or (B) a Compound, to
the extent included in a Combination Product, in each case ((A) or (B)) in the
Company Field in the Company Territory or in the TESARO Field in the TESARO
Territory (such Patent or other intellectual property to the extent relating to
the Compound, “Blocking Intellectual Property”), such Party shall so notify the
other Party and the following provisions of this Section 8.9(b) shall apply.  

(i)If such Blocking Intellectual Property relates solely to the Exploitation of
the Single Agent Products in the Company Field in the Company Territory or to
the Exploitation of a Combination Product Developed by Company in the Company
Field, then (x) Company shall have the sole right to negotiate and enter into an
agreement with the applicable Third Party to obtain a license or other rights to
such Blocking Intellectual Property (such agreement, a “Company Field License
Agreement”) or (y) at Company’s expense, TESARO shall use Commercially
Reasonable Efforts to take any actions reasonably requested by Company to modify
the Single Agent Product or the Exploitation thereof in the Company Field to
avoid the need to obtain a license or other rights to such Blocking Intellectual
Property. 

(ii)If such Blocking Intellectual Property relates solely to the Exploitation of
the Single Agent Products in the TESARO Field in the TESARO Territory or to the
Exploitation of a Combination Product Developed by TESARO in the TESARO Field,
then TESARO shall have the sole right to negotiate and enter into an agreement
with the applicable Third Party to obtain a license or other rights to such
Blocking Intellectual Property (such agreement, a “TESARO Field License
Agreement”).    

(iii)If such Blocking Intellectual Property relates to the Exploitation of the
Products in both the Company Field in the Company Territory and the TESARO Field
in the TESARO Territory, then the Parties shall discuss in

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[***] 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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good faith and attempt to agree upon a course of action, which may include (1)
modifying the Products or the Exploitation thereof to avoid the need to obtain a
license or other rights to such Blocking Intellectual Property or (2) entering
into an agreement with the applicable Third Party to obtain a license or other
rights to such Blocking Intellectual Property (such agreement, a
“Cross-Indication License Agreement”).  If the Parties do not reach agreement
within thirty (30) days, then TESARO shall have the right to determine the
course of action.  TESARO shall have the right to negotiate and enter into any
Cross-Indication License Agreement; provided,  however, that Company shall have
the right to consent (such consent not to be unreasonably withheld) to the terms
of such Cross-Indication License Agreement prior to TESARO’s execution thereof
if: (A) such Cross-Indication License Agreement includes a grant of rights with
respect to any product that is not a Product; or (B) any royalties, sublicense
revenues, milestones or other payments payable to the applicable Third Party
under such Cross-Indication License Agreement are different for the Company
Field than the TESARO Field.

(c)Obligations under Company Field License Agreements.  Company shall be solely
responsible for the payment of any royalties, sublicense revenues, milestones or
other payments that become due under the Company Field License Agreements as a
result of the Exploitation of the Products in the Company Field in the Company
Territory.  Company may credit [***] of any such payments that are attributable
and allocable to the Exploitation of a Combination Product or Prostate-Approved
Single Agent Product in the Company Field in the Company Territory against any
TESARO Incremental Royalty amounts payable to TESARO under Section
8.4(b)(ii).  Company shall take such credit during any Calendar Quarter for
which royalties are payable hereunder, provided that in no event will such
credit, together with any reductions under Section 8.6, reduce such royalties
payable to TESARO under Section 8.4(b)(ii) for such Calendar Quarter by more
than [***].  Any share of such payments that cannot be credited during a
Calendar Quarter as a result of the immediately preceding sentence may be
carried forward and credited to subsequent Calendar Quarters.  For clarity,
payments due under a Company Field License Agreement that are creditable against
TESARO Incremental Royalty amounts under this Section 8.9(c) may also be
creditable against the Pass-through Merck Royalty amounts under Exhibit
8.4(b)(i)(1), and Company shall credit [***] of such payments against the TESARO
Incremental Royalty amounts (to the extent permitted under this Section 8.9(c))
and [***] of such payments against Pass-through Merck Royalty amounts (to the
extent permitted under Exhibit 8.4(b)(i)(1)).  

(d)Obligations under TESARO Field License Agreements.  TESARO shall be solely
responsible for the payment of any royalties, sublicense revenues, milestones or
other payments that become due under the TESARO Field License

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[***] 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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Agreements as a result of the Exploitation of the Products in the TESARO Field
in the TESARO Territory.

(e)Obligations under Cross-Indication License Agreements.  TESARO shall be
solely responsible for the payment of any royalties, sublicense revenues,
milestones or other payments that become due under the Cross-Indication License
Agreements as a result of the Exploitation of the Products in the TESARO Field
in the TESARO Territory or the Company Field in the Company Territory (such
payments, the “Shared Third Party Obligations”).  TESARO may deduct the portion
of any Shared Third Party Obligation that is allocable to the Company Field from
the Alliance Payments as further described in Exhibit 8.3;  provided that, in
each relevant Alliance Payments Report, TESARO provides Company with a
reasonable allocation of such proposed deduction as between the U.S. and
non-U.S. markets.   

(f)If TESARO fails to pay any amount due under the Merck License Agreement,
AstraZeneca License Agreements or any Cross-Indication License Agreement and
such payment is not reasonably disputed by TESARO or the failure to make such
payment has placed TESARO in breach of an agreement with the applicable Third
Party, Company may elect, in its sole discretion upon [***] prior notice, to
make such payment to such Third Party on behalf of TESARO.  If Company makes
such payment to such Third Party, Company may deduct the amount of such payment
from any payments that are owed or that become owed to TESARO under this
Agreement or, if such deduction is not applicable, TESARO shall reimburse
Company the amount of such payment within [***] after Company makes such
payment. 

8.10Taxes.    

(a)The Parties agree to make all payments under this Agreement without deduction
or withholding for Taxes, including Taxes pursuant to the Foreign Account Tax
Compliance Act (“FATCA”), except to the extent that any such deduction or
withholding is required by Applicable Law in effect at the time of payment.

(b)Any Tax required to be withheld on amounts payable under this Agreement,
regardless of whether such amounts are actually withheld from any amounts
payable, shall be paid by payor on behalf of payee to the appropriate
Governmental Authority, and payor shall furnish payee with proof of payment of
such Tax.  Any Tax required to be withheld shall be an expense of and borne by
payee.  If any such Tax is assessed against and paid by payor, then payee will
indemnify and hold harmless payor from and against such Tax.

(c)Company and TESARO shall cooperate with respect to (i) minimizing any and all
deductions or withholding on account of Taxes, including by taking reasonable
actions necessary for the purpose of claiming treaty benefits that would reduce

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Taxes owed in connection with any payments, such actions to include, but not be
limited to, the provision of documentation required by any Governmental
Authority or reasonably requested by a Party to secure a reduction in the rate
of applicable withholding Taxes, and (ii) obtaining any refunds in respect of
Taxes deducted or withheld.  Notwithstanding the foregoing, if the payee is
entitled under any applicable Tax treaty or otherwise to a reduction of the rate
of, or the elimination of, the applicable withholding Tax, including FATCA
withholding Tax, it may deliver to the payor or the appropriate Governmental
Authority (with the assistance of the payor to the extent reasonably required)
the prescribed forms necessary to reduce the applicable rate of withholding or
to relieve the payor of its obligation to withhold Tax, and the payor shall
apply the reduced rate of withholding, or, as the case may be, dispense with
withholding of Tax.

(d)Notwithstanding anything to the contrary in this Agreement, if, as a result
of (i) a permitted assignment of this Agreement (in whole or in part) by a Party
owing payments under this Agreement (a “Paying Party”) to an Affiliate or a
Third Party outside of the U.S. or (ii) the exercise by a Paying Party of its
rights under this Agreement (in whole or in part) through an Affiliate or Third
Party outside of the U.S. (or the direct exercise of such rights by an Affiliate
of such Party outside of the U.S.), foreign withholding Tax in excess of the
withholding Tax amount that would have been payable by such Paying Party in the
absence of such assignment or exercise of rights becomes payable with respect to
amounts due to the other Party hereunder or thereunder, such amounts owed by the
Paying Party to the other Party (the “Non-Paying Party”) shall be increased for
the Incremental Tax Cost (as defined below) so that the amount actually paid by
such Paying Party to such Non-Paying Party equals the amount that would have
been payable to such Non-Paying Party in the absence of the assignment or
exercise of rights that caused the excess withholding (after withholding of the
excess withholding Tax and any additional withholding Tax on such increased
amount). However, if a similar assignment or exercise of rights described in (i)
or (ii) of the preceding sentence by a Non-Paying Party or the triggering of a
change of control by a Non-Paying Party results in foreign withholding tax in
excess of the withholding Tax amount that would have been payable in the absence
of such assignment or exercise of rights to such Non-Paying Party, any amount
due to such Non-Paying Party shall not be increased for such excess withholding
and, subject to the terms of this Agreement, the required amount shall be
withheld and submitted to the appropriate Governmental Authority.  For the
purposes of this Section 8.10, the “Incremental Tax Cost” shall equal any tax
amount withheld under this Section 8.10 in each year in which such tax is
withheld from the Non-Paying Party.  To the extent the Non-Paying Party utilizes
a foreign tax credit or claims a deduction on its US Federal income tax returns
related to any such Incremental Tax Cost that has the effect of reducing cash
payments currently owed to the U.S. Federal government in any year, the
Non-Paying Party will refund to the Paying Party an amount equal to (i) one
hundred percent (100%) of

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the foreign tax credit utilized or (ii) the cash tax benefit realized by the
Non-Paying Party resulting from any related foreign tax deductions, which
benefit will be calculated as the amount claimed as a deduction multiplied by
the effective federal corporate tax rate applicable to the Non-Paying Party.  To
assist the Paying Party in determining when a refund is due from the Non-Paying
Party pursuant to the foregoing sentence, beginning with the first Annual tax
return for the year in which the Paying Party pays the Non-Paying Party an
increased payment under this Section 8.10, and each year thereafter (including,
for clarity, all years in which the Non-Paying Party utilizes a tax credit or
claims a deduction for any foreign tax that is withheld and ending when either
no related foreign tax credit or previously claimed deduction remains to be
utilized), the Non-Paying Party will provide the Paying Party with a
certification by its third party tax return preparer as to the amount of credits
utilized or deductions taken against taxes owed by the Non-Paying party in the
current period and the cash benefit realized.

(e)The Parties hereby agree that each Party shall be entitled to any deductions
for Tax purposes attributable to such Party pursuant to or permitted by
Applicable Law and all Tax returns reflecting any such amounts shall be filed
consistent with the foregoing.  For the avoidance of doubt, one hundred percent
(100%) of amounts paid or incurred by TESARO pursuant to this Agreement shall be
deductible or amortizable solely by TESARO, and one hundred percent (100%) of
amounts paid or incurred by Company pursuant to this Agreement shall be
deductible or amortizable solely by Company.

8.11Audit.  Each Party and its Affiliates shall keep complete and accurate
records of the items underlying Net Sales, Alliance Payments and the other
elements required to prepare the reports or calculate payments required by
Sections 8.2(d) and 8.4, Exhibit 8.3,  Exhibit 8.4(b) and any other payments
under this Agreement.  Each Party will have the right, not more frequently than
every [***] or more frequently as required by the Merck License Agreement, at
its own expense to have an independent, certified public accountant, selected by
such Party and reasonably acceptable to the other Party, review any such records
of the other Party and its Affiliates in the location(s) where such records are
maintained by the other Party or its Affiliates upon thirty (30) days prior
written notice and during regular business hours and under obligations of
confidence, for the sole purpose of verifying the basis and accuracy of payments
made and the reconciliation procedures, and any other payments due under this
Agreement, within the prior 36-month period.  Each period may be subject to an
audit only one time (except as otherwise required by the Merck License
Agreement).  The report of the independent public accountant shall be shared
with the audited Party at least fifteen (15) days prior to distribution of the
final report to the auditing Party, such that the audited Party can provide the
independent public accountant with justifying remarks for inclusion in the
report prior to sharing the conclusions of such independent public audit with
the auditing Party.  The final audit report will be shared with the auditing
Party and audited Party at the same time and specify whether the amounts paid to
the auditing Party pursuant thereto were correct or, if incorrect, the amount of
any underpayment or overpayment. For royalties, the audit report shall only
contain the

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information relevant to support the statement as to whether the royalties were
calculated and paid accurately and shall not include any Confidential
Information of either Party (or additional information that is ordinarily not
included in the royalty reports) disclosed to the auditor during the course of
the audit.  If the review of such records reveals that the other Party has
failed to accurately report information, or make any payment (or portion
thereof) required under this Agreement, then the other Party shall promptly pay
to the auditing Party any underpaid amounts due, or otherwise due under this
Agreement, together with interest calculated in the manner provided in
Section 8.15.  If any such discrepancies are an underpayment of amounts due
under this Agreement greater than [***] of the amounts actually due for any
Calendar Year or TESARO Calendar Year, as applicable, the other Party shall pay
all reasonable costs incurred in conducting such review.  Once a Party has
conducted a review and audit of the other Party in respect of any given period,
it may not subsequently re-inspect the other Party’s or its Affiliates’ records
in respect of such period, unless a subsequent audit of a separate reporting
period uncovers fraud on the part of the audited Party that is reasonably
expected to have been occurring during the prior audited period.  For clarity,
however, if a discrepancy is identified by the accountant during the course of
an audit and the Parties do not agree upon a resolution of such discrepancy,
then the auditing Party’s accountant may re-inspect the books and records to the
extent reasonably relevant to resolving such discrepancy.  Additionally, Company
shall (a) keep and maintain records of sales of Products until the later of (i)
five (5) years after the end of the period to which such records pertain, and
(ii) the expiration of the applicable tax statute of limitations (or any
extensions thereof), or for such longer period as may be required by Applicable
Law, and (b) if any audit conducted by Merck under the Merck License Agreement
or by AstraZeneca under the AstraZeneca License Agreements reveals an
underpayment of royalties, then Company shall be responsible for a proportional
percentage of any audit fees due to Merck and/or AstraZeneca to the extent that
such underpayment is attributable to Company Prostate-Approved Single Agent
Product Net Sales or Company Combination Product Net Sales.    

8.12[***]  

8.13Other TESARO Invoices to Company.  Costs incurred by TESARO that are
reimbursable by Company under this Agreement but not deducted under Section 8.3
shall be invoiced by TESARO individually to Company, including prostate-specific
regulatory filing fees reimbursable pursuant to Section 3.5(iii) of Exhibit 8.3,
Technology Transfer Costs reimbursable pursuant to Section 7.3, and certain
costs of clinical supply and Compound API reimbursable pursuant to ARTICLE
7.  Company shall pay such invoices in accordance with Section 8.14.    

8.14Invoices.  Except to the extent otherwise provided in this Agreement, for
all payments due under this Agreement, except royalty payments, (a) the
receiving Party shall submit an invoice for such payment to the paying Party and
(b) such invoice shall be due and payable within [***] after receipt by the
paying Party, unless the paying Party disputes a portion thereof in good faith
(in which event the paying Party shall pay the undisputed portion thereof within
[***] after receipt).

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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8.15Late Payment.   All payments due to a Party hereunder, other than payments
disputed in good faith by a Party (but only until such dispute is resolved),
shall be made in U.S. Dollars by wire transfer of immediately available funds
into an account designated by the receiving Party.  Any sums owing but unpaid
shall bear interest calculated on a daily basis from the date due (taking into
account any extension of the applicable due date pursuant to another provision
of this Agreement) until the date paid at a rate equal to [***] in excess of
overnight U.S. LIBOR or a comparable reference interbank rate per currency. 

ARTICLE 9

INTELLECTUAL PROPERTY MATTERS 

9.1Ownership of Inventions.  Each Party shall own any Inventions made solely by
its (or its Affiliates’) own employees, agents, or independent contractors in
the course of conducting its activities under this Agreement, together with all
intellectual property rights therein (“Sole Inventions”).  The Parties shall
jointly own any Inventions for which the inventors include at least one
employee, agent, or independent contractor of each Party (or its respective
Affiliates) engaged in performing activities under this Agreement, together with
all intellectual property rights therein (“Joint Inventions”).  Ownership of
Inventions shall be determined in accordance with U.S. patent laws and
consistent throughout the TESARO Territory.  Subject to any licenses granted
under this Agreement, each Party will have the right to practice and Exploit any
Joint Inventions without the duty of accounting to any other Party or seeking
consent (for licensing, assigning or otherwise exploiting Joint Inventions) from
the other Party by reason of the joint ownership thereof; and each Party hereby
waives any right such Party may have under the laws of any jurisdiction to
require any such approval or accounting and, to the extent there are any
Applicable Laws that prohibit such a waiver, each Party will be deemed to have
so consented.  In furtherance thereof, at the reasonable written request of a
Party, the other Party will in writing grant such consents and confirm that no
such accounting is required to effect the foregoing regarding Joint Inventions.

9.2Disclosure of Inventions.  Each Party shall promptly disclose to the other
Party any Invention that is necessary or useful to Exploit Compounds or Products
in the other Party’s Field during the Term.  With respect to any Joint
Invention, each Party shall promptly disclose to the other Party any invention
disclosures, or other similar documents, submitted to it by its employees,
agents or independent contractors describing the Joint Invention, and all
Know-How relating to such Invention to the extent necessary for the use of such
Invention in the Exploitation of the Compounds and Products in such other
Party’s Field and, to the extent patentable, for the preparation, filing and
maintenance of any Patent with respect to such Invention.  No licenses to
Know-How are granted by this Section 9.2, and nothing under this Section 9.2
shall require a Party to disclose to the other Party any Know-How related to an
active pharmaceutical ingredient that is not a Compound or to a proprietary
formulation technology.

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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9.3Prosecution of Patents.

(a)Merck Patents.  Company acknowledges and agrees that Merck has the first
right to prosecute and maintain the Merck Patents under the Merck License
Agreement.  TESARO shall promptly provide to Company any information received
from Merck relating to the prosecution and maintenance of the Merck
Patents.  TESARO shall consult with Company, to the extent practicable, and
shall consider Company’s comments in good faith, prior to exercising its rights
under Sections 8.01 or 8.02 of the Merck License Agreement.  If TESARO exercises
its right under Section 8.02 of the Merck License Agreement to prosecute and
maintain a Merck Patent, such Merck Patent shall be deemed to be an Other TESARO
Patent and TESARO shall have the right to prepare, file, prosecute and maintain
such Patent as set forth in Section 9.3(c).

(b)AstraZeneca Patents.  Company acknowledges and agrees that AstraZeneca has
the sole right to prosecute and maintain the AstraZeneca Patents.  TESARO shall
promptly notify Company upon receiving notice from AstraZeneca that AstraZeneca
has declined to continue to prosecute or maintain any AstraZeneca Patent in any
jurisdiction.

(c)Other TESARO Patents.  TESARO shall have the sole right and authority to
prepare, file, prosecute and maintain the Other TESARO Patents [***].  TESARO
shall provide Company a reasonable opportunity to review and comment on its
efforts to prepare, file, prosecute and maintain Other TESARO Patents in the
Company Territory, including by providing Company with a copy of material
communications from any patent authority in the Company Territory regarding any
Other TESARO Patent, and by providing drafts of any material filings or
responses to be made to such patent authorities in advance of submitting such
filings or responses.  TESARO shall consider Company’s comments regarding such
communications and drafts in good faith.    

(d)Company Patents.  Company shall have the sole right and authority to prepare,
file, prosecute and maintain the Company Patents [***].  Company shall provide
TESARO a reasonable opportunity to review and comment on its efforts to prepare,
file, prosecute and maintain Company Patents in the TESARO Territory, including
by providing TESARO with a copy of material communications from any patent
authority regarding any Company Patent in the TESARO Territory, and by providing
drafts of any material filings or responses to be made to such patent
authorities in advance of submitting such filings or responses.  Company shall
consider TESARO’s comments regarding such communications and drafts in good
faith. 

(e)Joint Patents.  Except as otherwise provided in this Section 9.3(e), Company
shall have the primary right and authority to prepare, file, prosecute and
maintain the Patents included in the Joint Inventions (“Joint Patents”)
[***].  Company shall provide TESARO with a reasonable opportunity to review and
comment on

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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its efforts to prepare, file, prosecute and maintain Joint Patents, including by
providing TESARO with a copy of material communications from any patent
authority regarding any Joint Patent, and by providing drafts of any material
filings or responses to be made in advance of submitting such filings or
responses.  Company shall consider TESARO’s comments regarding such
communications and drafts in good faith.  If Company determines, in its
discretion, to abandon or not maintain any Joint Patent(s) in any country(ies)
of the world that Cover a Compound or Single Agent Product, then Company shall
provide TESARO with written notice of such determination within a period of time
reasonably necessary to allow TESARO to determine its interest in such Joint
Patent(s) (which notice from Company shall be given no later than sixty (60)
days prior to any final deadline for any pending action or response that may be
due with respect to such Joint Patent(s) with the applicable patent
authority).  If TESARO provides written notice expressing its interest in
obtaining such Joint Patent(s), Company shall[***] assign and transfer to TESARO
the ownership of, and interest in, such Joint Patent(s) in such country(ies), at
TESARO’s own expense, and Company shall cooperate with TESARO for assignment and
transfer of such Joint Patent(s) in such country.  Thereafter, all such assigned
and transferred Patents will be deemed Other TESARO Patents and TESARO shall
have the right to prepare, file, prosecute and maintain such Patents as set
forth in Section 9.3(c).

(f)Cooperation in Prosecution.  Each Party shall provide the other Party all
reasonable assistance and cooperation in the Patent prosecution efforts provided
above in this Section 9.3, including providing any necessary powers of attorney
and executing any other required documents or instruments for such prosecution,
as well as further actions as set forth below.  Such assistance and cooperation
shall include making a Party’s inventors and other scientific advisors
reasonably available to assist the other Party’s Patent prosecution efforts. 

(i)The Parties shall respectively prepare, file, maintain and prosecute the
Other TESARO Patents, the Company Patents and the Joint Patents as set forth in
this Section 9.3.  As used herein, “prosecution” of such Patents shall include
all communication and other interaction with any patent office or patent
authority having jurisdiction over a patent application in connection with
pre-grant proceedings.

(ii)All communications between the Parties relating to the preparation, filing,
prosecution or maintenance of the Other TESARO Patents, the Company Patents and
the Joint Patents, including copies of any draft or final documents or any
communications received from or sent to patent offices or patenting authorities
with respect to such Patents, shall be considered Confidential Information of
the Party Controlling the relevant Patent and subject to the confidentiality
provisions of ARTICLE 11.

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(iii)Assignments in the Other TESARO Patents, Joint Patents and Company Patents
shall be effected as follows: (i) employees or agents of TESARO (or its
Affiliates) that are named as inventors on the Other TESARO Patents shall assign
their interest in such Patents to TESARO or its Affiliate; (ii) employees or
agents of Company or TESARO (or their respective Affiliates) that are named as
inventors on the Joint Patents shall assign their interest in such Patents to
their respective employer; and (iii) employees or agents of Company (or its
Affiliates) that are named as inventors on the Company Patents shall assign
their interests in such Patents to Company or its Affiliate.

9.4Patent Term Extensions in the Territory.   For each Product in the Company
Field as to which a Party owns a Marketing Approval, such Party shall decide for
which, if any, of the Patents Controlled by such Party, its Affiliates or
designees the Parties should seek patent term extensions, supplemental
protection certificates or their equivalents (each a “Patent Extension” and
collectively “Patent Extensions”) in the Company Territory and such Party shall
have the right to seek such Patent Extensions.  Each Party may request of the
other Party that a TESARO Patent, Joint Patent or Company Patent Controlled by
such Party, its Affiliates or designees be made available to the requesting
Party for Patent Extension for a Product in the Company Field as to which it
owns the Marketing Approval and such other Party will not unreasonably deny such
request.  Neither Party shall seek any Patent Extension that is reasonably
likely to have a material adverse effect on the Commercialization of a Product
or if there is a good faith dispute between the Parties as to whether a Patent
Extension is being sought for a Patent that does not Cover the applicable
Product (a “Good Faith Dispute”).  The Party that does not apply for a Patent
Extension hereunder will cooperate fully with the other Party in making such
filings or actions, including making available all required regulatory data and
information and executing any required authorizations to apply for such Patent
Extension.  [***] Notwithstanding any provision of this Section 9.4 to the
contrary, TESARO shall have the first right to select TESARO Patents for Patent
Extensions and may object to the selection by Company of a TESARO Patent for a
Patent Extension and may, by written notice to Company prohibit such selection.

9.5Infringement of Patents by Third Parties.    

(a)Notification.  Each Party shall promptly notify the other Party in writing of
any existing, alleged or threatened infringement of any TESARO Patent, Joint
Patent or Company Patent of which it becomes aware, and shall provide all
information in such Party’s possession or control demonstrating such
infringement.

(b)Infringement of TESARO Patents, Company Patents or Joint Patents.

(i)TESARO, subject to Sections 9.5(b)(ii) through 9.5(b)(vii) and to the extent
TESARO has such right under the TESARO License Agreements, shall have the first
right, but not the obligation, to elect to bring an

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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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appropriate suit or other action against any Third Party engaged in any
existing, alleged or threatened infringement of any TESARO Patent, Company
Patent or Joint Patent in each case Covering a Compound or Single Agent
Product. 

(ii)TESARO shall notify Company of its election to take any action or not to
take any action in accordance with Section 9.5(b)(i) within the earlier of:
(i) [***] after the first notice under Section 9.5(a); or (ii) [***] before any
time limit set forth in Applicable Law or regulation, including the time limits
set forth under the Drug Price Competition and Patent Term Restoration Act of
1984, commonly referred to as the “Hatch-Waxman Act.”  If TESARO elects to
initiate a lawsuit or take other reasonable action with respect to an
infringement described in Section 9.5(b)(i), TESARO shall not initiate any such
suit or take such other action with respect to any TESARO Patent, Company Patent
or Joint Patent without first consulting with Company and giving good faith
consideration to any reasonable objection from Company regarding TESARO’s
proposed course of action, and TESARO shall not initiate any such suit or take
such other action with respect to a Company Patent without the prior written
consent of Company, such consent not to be unreasonably withheld, delayed or
conditioned.  Company shall cooperate in the prosecution of any suit under this
Section 9.5 as may be reasonably requested by TESARO.  If TESARO elects not to
initiate a lawsuit or take other reasonable action with respect to an
infringement described in Section 9.5(b)(i), Company shall have the right, but
not the obligation, to initiate such suit or take such other action, after
providing [***] (or [***] in the event there is a time limit) notice to TESARO
and giving good faith consideration to TESARO’s reason(s) for not initiating a
suit or taking other action.

(iii)If one Party elects to bring suit or take action under this Section 9.5(b)
against an infringement, then the other Party shall have the right, prior to
commencement of the suit or action, to join any such suit or action.

(iv)Each Party shall provide to the Party enforcing any such rights under this
Section 9.5(b) reasonable assistance in such enforcement, at such enforcing
Party’s request and expense, including joining such action as a party plaintiff
if required by Applicable Law to pursue such action.  The enforcing Party shall
keep the other Party regularly informed of the status and progress of such
enforcement efforts, shall reasonably consider the other Party’s comments on any
such efforts, and shall consult the other Party in any important aspects of such
enforcement, including determination of material litigation strategy and filing
of important papers to the competent court.

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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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(v)Each Party shall bear all of its own internal costs incurred in connection
with its activities under this Section 9.5(b).  In the event that the Parties
are joined in suit or action against the infringement or the non-enforcing Party
elects to join such suit or action and, in either case, the non-enforcing Party
elects to be represented by the same outside counsel as the enforcing Party,
then the enforcing Party shall be responsible for all expenses arising from such
outside counsel, provided that the enforcing Party consents to such joint
representation by outside counsel, such consent not to be unreasonably withheld,
delayed or conditioned.

(vi)The Party not bringing an action with respect to infringement under this
Section 9.5(b) shall be entitled to separate representation in such matter by
counsel of its own choice and at its own expense, but such Party shall at all
times cooperate fully with the Party bringing such action.

(vii)Neither Party shall settle any claim, suit or action that it brought under
this Section 9.5 involving TESARO Patents, Company Patents or Joint Patents
without the prior written consent of the other Party, such consent not to be
unreasonably withheld, delayed or conditioned.

(viii)Company acknowledges and agrees that, under the terms of the AstraZeneca
License Agreements, AstraZeneca has the sole right to enforce the AstraZeneca
Patents and to defend any claim pertaining to the validity or enforceability of
the AstraZeneca Patents.  [***]

(c)Allocation of Proceeds.  If either Party recovers monetary damages from any
Third Party in a suit or action brought under Section 9.5(b), 9.7(a) or 9.7(b)
or any royalties, milestones or other payments from a license agreement with a
Third Party related to any alleged infringement related to a Product, whether
such damages or royalties result from the infringement of TESARO Patents, Joint
Patents or Company Patents, such recovery (“Infringement Recovery”) shall be
allocated first to the reimbursement of any expenses incurred by the Parties in
such litigation, action or license negotiations, and any remaining amounts shall
be allocated as follows:

(i)If the Infringement Recovery is based upon lost profits of a Product, then
the Parties will divide revenue or pay royalties as provided in this Agreement,
calculated on the Net Sales which formed the basis of the lost profit claim for
the remaining recovery amount as if a Party had made such Net Sales; and

(ii)If the Infringement Recovery is based on the allocation of a reasonable
royalty as to a competing product, then, relative to a Compound, the Parties
will allocate the remaining recovery amount based on the ratio that Net Sales of
a Product in an Indication in the country in which such suit or

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[***] 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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action was brought bears to net sales of all Products outside of an Indication
in such country, with Company receiving that portion of the Infringement
Recovery attributable to Net Sales of a Product in an Indication based on this
ratio.

The allocation described above is subject to any allocation provided by the
Merck License Agreement or the AstraZeneca License Agreements.  

9.6Infringement of Third Party Rights in the Territory.

(a)Notice.  If any Product used or sold by either Party, its Affiliates, or
(sub)licensees becomes the subject of a Third Party’s claim or assertion of
infringement of a Patent granted by a jurisdiction within the Company Territory
(each, an “Infringement Claim”), the Party first having notice of the claim or
assertion shall promptly notify the other Party.  In the event that such
Infringement Claim relates to the use or sale of the Single Agent Product in the
Company Field, TESARO shall use Commercially Reasonable Efforts to take any
actions reasonably requested by Company to mitigate damages or modify the
infringing activity to render it non-infringing with respect to the Company
Field.

(b)Defense.    

(i)With respect to any Infringement Claim that solely relates to the use or sale
of the Single Agent Product in the Company Field, Company shall have the first
right, but not the obligation, to defend, settle or otherwise dispose of such
Infringement Claim [***].  If Company does not commence actions to defend,
settle or otherwise dispose of such Infringement Claim within [***] after it
receives notice thereof (or within [***] after it should have given notice
thereof to TESARO as required by Section 9.6(a)), then, to the extent allowed by
Applicable Law, TESARO shall have the right, but not the obligation, to defend,
settle or otherwise dispose of such Infringement Claim using counsel of its
choice[***]. 

(ii)With respect to any Infringement Claim that relates to the use or sale of
the Single Agent Product other than an Infringement Claim described in Section
9.6(b)(i), TESARO shall have the first right, but not the obligation, to defend,
settle or otherwise dispose of such Infringement Claim [***]. If TESARO does not
commence actions to defend settle or otherwise dispose of such Infringement
Claim within [***] after it receives notice thereof, then, to the extent allowed
by Applicable Law, Company shall have the right, but not the obligation, to
defend, settle or otherwise dispose of such Infringement Claim using counsel of
its choice[***]. 

(iii)With respect to any Infringement Claim that relates to use or sale of a
Combination Product Developed by Company in the Company Field,

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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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Company shall have the sole right, but not the obligation, to defend, settle or
otherwise dispose of such Infringement Claim [***]. 

(iv)With respect to any Infringement Claim that relates to use or sale of a
Combination Product Developed by TESARO in the TESARO Field, TESARO shall have
the sole right, but not the obligation, to defend, settle or otherwise dispose
of respond to such Infringement Claim [***].

(v)With respect to any Infringement Claim, the non-defending Party shall
reasonably cooperate with the Party that defends or otherwise responds to such
Infringement Claim in accordance with this Section 9.6(b), including if required
to conduct such defense, furnishing a power of attorney.

(c)Settlement; Licenses.  A Party shall not enter into any settlement of any
Infringement Claim that affects the other Party’s rights or interests without
the other Party’s prior written consent, such consent not to be unreasonably
withheld, delayed or conditioned.  Each Party shall have the right to decline to
defend or to tender defense of any Infringement Claim upon reasonable notice to
the other Party, including if the other Party fails to agree to a settlement
that the declining Party proposes.  In the event that it is determined by any
court of competent jurisdiction in response to an Infringement Claim that the
Exploitation of a Compound or the Products, conducted in accordance with the
terms and conditions of this Agreement, infringes any Patent, copyright,
Trademark, data exclusivity right or trade secret right arising under Applicable
Law of any Third Party, then notwithstanding anything to the contrary in Section
8.9(b), the Party defending such Infringement Claim shall use Commercially
Reasonable Efforts to: (1) negotiate and procure a license from such Third Party
authorizing itself and the other Party to continue to conduct such activities
(and the costs of such license shall be borne by the Parties as set forth in
Section 8.9); or (2) in good faith with the other Party modify such activities
so as to render the activities non-infringing. 

(d)Applicability to Merck Patents.  Notwithstanding anything to the contrary set
forth in this Section 9.6, if the notice delivered under Section 9.6(a) relates
to a Merck Patent that is subject to Section 8.04 of the Merck License
Agreement, TESARO’s obligations under this Section 9.6 shall be subject to
compliance with Section 8.04 of the Merck License Agreement.

9.7Patent Oppositions and Other Proceedings.

(a)Third Party Patent Rights.  If either Party desires to bring an opposition,
action for declaratory judgment, nullity action, interference, declaration for
non-infringement, reexamination or other attack upon the validity, title or
enforceability of a Patent owned or controlled by a Third Party and having one
or more claims that Cover a Compound or Single Agent Product, or the use, sale,
offer for sale or importation thereof (except insofar as such action is a

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[***] 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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counterclaim to or defense of, or accompanies a defense of, an Infringement
Claim under Section 9.6, in which case the provisions of Section 9.6 shall
govern), such Party shall so notify the other Party and the Parties shall
promptly confer to determine whether to bring such action or the manner in which
to settle such action.  For each Product in the Company Field as to which a
Party owns the Marketing Approval, such Party shall have the first right, but
not the obligation, to bring[***] in its sole control, such action [***].  The
Party not bringing an action under this Section 9.7(a) shall be entitled to
separate representation in such proceeding by counsel of its own choice and at
its own expense, and shall cooperate fully with the Party bringing such
action.  Any awards or amounts received in bringing any such action shall be
first allocated to reimburse the initiating Party’s expenses in such
action[***].

(b)Parties’ Patent Rights.  If any TESARO Patent, Company Patent or Joint Patent
becomes the subject of any proceeding commenced by a Third Party in connection
with an opposition, reexamination request, action for declaratory judgment,
nullity action, interference or other attack upon the validity, title or
enforceability thereof (a “Third Party Patent Challenge”) (except insofar as
such action is a counterclaim to or defense of, or accompanies a defense of, an
action for infringement against a Third Party under Section 9.6, in which case
the provisions of Section 9.6 shall govern), then the Party responsible for
filing, preparing, prosecuting and maintaining such Patent as set forth in
Section 9.3 hereof shall control such defense [***].  The controlling Party
shall permit the non-controlling Party to participate in the proceeding to the
extent permissible under Applicable Law, and to be represented by its own
counsel in such proceeding, at the non-controlling Party’s expense.  If either
Party decides that it does not wish to defend against such action, then the
other Party shall have a backup right to assume defense of such Third Party
action [***].  Any awards or amounts received in defending any such Third Party
action shall be [***].    

ARTICLE 10

REPRESENTATIONS, WARRANTIES AND COVENANTS

10.1Mutual Representations, Warranties and Covenants.  Each of the Parties
hereby represents and warrants to the other Party as of the Effective Date and,
as applicable, covenants as of the Effective Date that:

(a)Organization.    It is a corporation duly organized, validly existing, and in
good standing under the laws of the jurisdiction of its organization, and has
all requisite corporate power and authority to execute, deliver, and perform
this Agreement.

(b)Binding Agreement.    This Agreement is a legal and valid obligation binding
upon such Party and enforceable in accordance with its terms, subject to the
effects of bankruptcy, insolvency, or other laws of general application
affecting

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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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the enforcement of creditor rights, judicial principles affecting the
availability of specific performance, and general principles of equity (whether
enforceability is considered a proceeding at law or equity) (the “Equitable
Exceptions”). 

(c)Authorization.    The execution, delivery, and performance of this Agreement
by such Party have been duly authorized by all necessary corporate action and do
not conflict with any agreement, obligation, instrument, or understanding, oral
or written, to which it is a party or by which it is bound, nor violate any
Applicable Law or any order, writ, judgment, injunction, decree, determination,
or award of any Governmental Authority presently in effect applicable to such
Party.

(d)No Further Approval.  It is not aware of any government authorization,
consent, approval, license, exemption of or filing or registration with any
Governmental Authority under any Applicable Law, currently in effect, necessary
for the execution and delivery of this Agreement or any other agreement or
instrument executed in connection herewith, or for the performance by it of its
obligations under this Agreement and such other agreements (save for Regulatory
Approvals, Marketing Approvals and other authorizations, consents, approvals,
licenses, exemptions, filings, registrations or permits from Governmental
Authorities necessary for the Exploitation of the Compounds and Products as
contemplated hereunder).

(e)TESARO License Agreements.  Each Party shall, and shall cause their
respective Affiliates and sublicensees, to comply with the terms and conditions
of the TESARO License Agreements that apply to sublicensees of the rights
granted to TESARO under such TESARO License Agreements. 

(f)No Inconsistent Obligations.    It is not under any obligation, contractual
or otherwise, to any Person that conflicts with or is inconsistent in any
material respect with the terms of this Agreement, or that would impede the
diligent and complete fulfillment of its obligations hereunder.

10.2Additional Representations and Warranties of TESARO.  TESARO represents and
warrants as of the Effective Date and, as applicable, covenants as of the
Effective Date to Company that: 

(a)TESARO (or its Affiliates) is the sole and exclusive owner of, or otherwise
Controls pursuant to an existing Third Party agreement, the TESARO Technology
and the TESARO Regulatory Documentation.  TESARO has all rights necessary to
grant the licenses under the TESARO Technology and Rights of Reference under the
TESARO Regulatory Documentation that it grants to Company in this
Agreement.  Neither TESARO nor any of its Affiliates has granted a license to
any Third Party under the TESARO Technology or TESARO Regulatory Documentation
to Exploit the Compounds or Products in the TESARO Field or Company Field, other
than those licenses granted by TESARO in the ordinary

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[***] 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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course of its business to Third Parties working under TESARO’s direction and
control, such as licenses to contract research organizations, clinical trial
sites, contract manufacturing organizations and licenses in connection with the
development of companion diagnostic products.  During the Term, TESARO shall
not, and shall cause its Affiliates not to, grant to any Third Party rights that
conflict with the rights granted to Company hereunder with respect to the TESARO
Technology or TESARO Regulatory Materials.  

(b)The Patents set forth in Exhibit 1.117 (“Licensed Patents”) represent all
Patents that TESARO or any of its Affiliates owns or Controls that Cover or
disclose any invention necessary or used by TESARO for the Exploitation of the
Compounds or Products by TESARO as of the Effective Date. The Licensed Patents
are free and clear of liens, charges or encumbrances other than licenses granted
to or by Third Parties that are not inconsistent with the rights and licenses
granted to Company hereunder.  To TESARO’s knowledge, the Licensed Patents are
not invalid or unenforceable in whole or part.  No Third Party has challenged or
threatened in writing to challenge the scope, validity or enforceability of any
Licensed Patent (including, by way of example, through opposition or the
institution or written threat of institution of interference, nullity or similar
invalidity proceedings before the U.S. Patent and Trademark Office or any
analogous foreign Governmental Authorities).  During the period TESARO has
Controlled the Licensed Patents, TESARO or its Affiliates have timely paid or
caused to be paid all filing and renewal fees payable with respect to any
Licensed Patents for which TESARO controls prosecution and maintenance.  The
development of the Licensed Patents has not been funded, in whole or in part, by
the U.S. government.

(c)TESARO or its Affiliates own or Control all Know-How necessary or used by
TESARO for the Exploitation of the Compounds or Products by TESARO as of the
Effective Date.  The TESARO Know-How is free and clear of liens, charges or
encumbrances other than licenses granted by TESARO to Third Parties that are not
inconsistent with the rights and licenses granted to Company hereunder.  TESARO
and its Affiliates have taken commercially reasonable measures consistent with
industry practices to protect the secrecy, confidentiality and value of all
TESARO Know-How that constitutes trade secrets under Applicable Law (including
requiring all TESARO and its Affiliates’ employees, consultants and independent
contractors to execute binding and enforceable agreements, except as
enforceability may be limited or affected by the Equitable Exceptions, requiring
all such employees, consultants and independent contractors to maintain the
confidentiality of such TESARO Know-How).  The development of the TESARO
Know-How has not been funded, in whole or in part, by the U.S. government.

(d)There is no actual or, to TESARO’s Knowledge, threatened infringement or
misappropriation of the TESARO Technology by any Person in the Company

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[***] 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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Field in the Company Territory.    TESARO has not received any written notice or
threat of any material suit, legal claim, action, proceeding or investigation
against TESARO or any of its Affiliates that relates to the TESARO Technology,
and no judgment or settlement is owed by TESARO or any of its Affiliates in
connection with the TESARO Technology.

(e)The TESARO Technology collectively constitutes all intellectual property that
is necessary or used by TESARO for the Exploitation of the Compounds and the
Products by TESARO as of the Effective Date.  To TESARO’s Knowledge, except as
otherwise disclosed by TESARO to Company, the Exploitation of the Compounds or
Products in the Company Territory does not and will not infringe or
misappropriate the Patents (including any Third Party patent application
published as of the Effective Date, when and if the claims thereunder issue in
their current form) or other intellectual property or proprietary rights of any
Third Party in the Company Territory.

(f)All current and former officers, employees, agents, advisors, consultants,
contractors or other representatives of TESARO or any of its Affiliates who are
inventors of or have otherwise contributed in a material manner to the creation
or development of any TESARO Technology have executed and delivered to TESARO or
any such Affiliate a valid and enforceable assignment or other agreement, except
as enforceability may be limited or affected by the Equitable Exceptions,
regarding the protection of proprietary information and the assignment to TESARO
or any such Affiliate of such person’s entire right, title and interest in and
to any TESARO Technology.  To TESARO’s Knowledge, no current officer, employee,
agent, advisor, consultant or other representative of TESARO or any of its
Affiliates is in violation of any term of any assignment or other agreement
regarding the protection of TESARO Patents or other TESARO Technology or of any
employment contract or any other contractual obligation relating to the
relationship of any such Person with TESARO or any such Affiliate.  Except for
consideration expressly contemplated by this Agreement, Company shall have no
obligation to contribute to any remuneration of any inventor employed or
previously employed by TESARO or any of its Affiliates in respect of any
Know-How and intellectual property rights therein that are so assigned to TESARO
or its Affiliate(s).  TESARO will pay all such remuneration due to such
inventors with respect to such Know-How and intellectual property rights
therein.

(g)TESARO has prepared, maintained and retained all Regulatory Documentation
pursuant to and in accordance in all material respects with all Applicable Law,
including, as applicable, GLP, and such Regulatory Documentation does not
contain any materially false and misleading statements.

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[***] 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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(h)TESARO has conducted, and has used reasonable efforts to cause its
contractors and consultants to conduct, all studies, tests and pre-clinical
trials of the Compounds and the Products conducted prior to, or being conducted
on, the Effective Date in accordance in all material respects with the
applicable experimental protocols, procedures and controls pursuant to accepted
professional scientific standards, accepted ethical standards and all Applicable
Law, including, as applicable, GLP.  Except as disclosed in the adverse event
reports disclosed or made available to Company prior to the Effective Date (or
otherwise disclosed in writing by TESARO to Company prior to the Effective
Date), no adverse event involving human subjects has occurred in connection with
any study, test or pre-clinical trial of the Compounds or the Products. 

(i)TESARO has disclosed or made available to Company all material information in
its possession and control relating to the Compounds and Products, and the
Development, Manufacture and Commercialization of the Initial Compound and
Initial Product as conducted prior to the Effective Date, including by providing
or making available complete and correct copies of the following: (i) adverse
event reports; (ii) clinical study reports and material study data; and (iii)
FDA inspection reports, notices of adverse findings, warning letters, Regulatory
Approval filings and other material Regulatory Documentation.

(j)Except for (i) Development activities (other than Clinical Trials) conducted
on behalf of TESARO in the ordinary course of business and (ii) the Development
activities described on Exhibit 10.2(j), neither TESARO nor any of its
Affiliates has conducted, nor granted any Third Party a license or otherwise
enabled a Third Party to conduct, any Development of the Compounds or Products
in the Company Field in the Company Territory.    

(k)Neither TESARO nor any of its Affiliates has been debarred by the FDA, is the
subject of a conviction described in Section 306 of the FFDCA or is subject to
any similar sanction of other Governmental Authorities in the Company Territory.
Neither TESARO nor any of its Affiliates has used, in any capacity, any Person
who either has been debarred by the FDA, is the subject of a conviction
described in Section 306 of the FFDCA or is subject to any such similar sanction
in the Development, Manufacture or Commercialization of the Initial Compound or
Initial Product as conducted prior to the Effective Date.  TESARO shall not
engage, in any capacity in connection with this Agreement or any ancillary
agreements, any Person who either has been debarred by the FDA, is the subject
of a conviction described in Section 306 of the FFDCA or is subject to any such
similar sanction.  TESARO shall inform Company in writing promptly if it or any
Person engaged by TESARO or any of its Affiliates who is performing services
under this Agreement or any ancillary agreements is debarred or is the subject
of a conviction described in Section 306 of the FFDCA, or if any action, suit,
claim, investigation or legal or administrative proceeding is pending or, to
TESARO’s

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[***] 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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Knowledge, is threatened, relating to the debarment or conviction of TESARO, any
of its Affiliates or any such Person performing services hereunder or
thereunder.

(l)TESARO has provided Company with complete and correct copies of each TESARO
License Agreement (including all amendments and supplements thereto).  Each
TESARO License Agreement is in full force and effect and TESARO and its
Affiliates are in compliance in all material respects with the terms of each
TESARO License Agreement.  During the Term, TESARO shall continue to comply in
all material respects with the terms of each TESARO License Agreement, and shall
not terminate, modify, waive any rights under or otherwise take any action with
respect to any TESARO License Agreement that would reasonably be expected to
materially impact the rights granted to Company hereunder without Company’s
prior written consent.

(m)None of TESARO or any of its Affiliates has, nor, to the Knowledge of TESARO,
has any Third Party that is a party to a TESARO License Agreement, materially
breached or materially defaulted under, or is in material breach of or material
default under, its obligations under such TESARO License Agreement. 

(n)Neither TESARO nor any of its Affiliates has received written notice from any
Third Party that is a party to a TESARO License Agreement claiming that TESARO
or any of its Affiliates has breached or defaulted under, or is in breach of or
default under, its obligations under such TESARO License Agreement.  If TESARO
or any of its Affiliates receives any such written notice during the Term,
TESARO shall provide a copy thereof to Company promptly after receipt and,
following consultation with Company, TESARO shall (and shall cause its
Affiliates to) consider Company’s input in good faith and shall take such
actions as may be reasonably necessary to cure any breach or default. 

(o)Neither TESARO nor any of its Affiliates has waived any material right under
any TESARO License Agreement.

(p)Subject to the terms of the Merck License Agreement, TESARO has the right to
grant sublicenses under each TESARO License Agreement in accordance with the
terms and conditions thereof and to the extent such sublicenses are granted to
Company hereunder without the consent of any Third Party that is a party to such
TESARO License Agreement.

10.3Additional Representations and Warranties of Company.  Company represents
and warrants as of the Effective Date and covenants as of the Effective Date to
TESARO that:

(a)Neither Company nor any of its Affiliates has been debarred by the FDA, is
the subject of a conviction described in Section 306 of the FFDCA or is subject
to any similar sanction of other Governmental Authorities in the Company
Territory,

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[***] 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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and neither Company nor any of its Affiliates has used, in any capacity, any
Person who either has been debarred by the FDA, is the subject of a conviction
described in Section 306 of the FFDCA or is subject to any such similar
sanction.  Company shall not engage, in any capacity in connection with this
Agreement or any ancillary agreements, any Person who either has been debarred
by the FDA, is the subject of a conviction described in Section 306 of the FFDCA
or is subject to any such similar sanction.  Company shall inform TESARO in
writing promptly if it or any Person engaged by Company or any of its Affiliates
who is performing services under this Agreement or any ancillary agreements is
debarred or is the subject of a conviction described in Section 306 of the
FFDCA, or if any action, suit, claim, investigation or legal or administrative
proceeding is pending or, to Company’s Knowledge, is threatened, relating to the
debarment or conviction of Company, any of its Affiliates or any such Person
performing services hereunder or thereunder.

(b)Company is not subject to any agreement with any Third Party which would
limit or restrict its ability to perform its obligations under this Agreement in
any material respect.

10.4Merck License Agreement.  The provisions of the Merck License Agreement set
forth on Exhibit 10.4 attached hereto are specifically incorporated herein, with
the terms used therein that are defined in the Merck License Agreement having
the same meanings as ascribed to such terms in the Merck License Agreement, and
Company shall comply with such provisions during the Merck Term as if Company
were TESARO thereunder.  Company hereby covenants that it shall not, nor shall
it cause, permit or enable any Affiliate or (sub)licensee to knowingly use or
practice, directly or indirectly, any Merck Know-How or Merck Patents for any
purposes other than those expressly permitted by this Agreement.

10.5Certain Compliance Matters.    

(a)Notwithstanding any other provision of this Agreement, neither Party shall be
required to undertake any activity or obligation under this Agreement which it
has reason to believe may violate any Applicable Laws; provided,  however, a
Party which so believes shall promptly inform the other Party of such belief.

(b)Neither Party nor its Affiliates will make any payment, either directly or
indirectly, of money or other assets, including the compensation such Party
derives from this Agreement (collectively, a “Payment”), to government or
political party officials, officials of International Public Organizations,
candidates for public office, or representatives of other businesses or persons
acting on behalf of any of the foregoing (collectively, “Officials”) or other
individuals where such Payment would constitute violation of any Applicable Law,
including the Foreign Corrupt Practices Act of 1977, 15 U.S.C. §§ 78dd-1, et
seq., and the United Kingdom Bribery Act.  In addition regardless of legality,
neither Party nor

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[***] 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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its Affiliates will make any Payment either directly or indirectly to Officials
or other individuals if such Payment is for the purpose of improperly
influencing decisions or actions to secure a business advantage, including with
respect to the subject matter of this Agreement.  Each Party shall have
necessary procedures in place to prevent bribery and corrupt conduct by itself
and each of its Affiliates and subcontractors.  All activities will be conducted
in compliance with the U.S. False Claims Act and the U.S. Anti-Kickback
Statute.  Each Party and each of its Affiliates and subcontractors shall conduct
its activities hereunder in accordance with the provisions of Exhibit 10.5 to
this Agreement.    

10.6No Other Representations or Warranties.  EXCEPT AS EXPRESSLY SET FORTH IN
THIS ARTICLE 10, THE PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND
WHATSOEVER, EITHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, IN FACT OR BY OPERATION
OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER
WARRANTIES, INCLUDING ANY EXPRESS OR IMPLIED WARRANTY OF QUALITY,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF
NON-INFRINGEMENT OR AS TO THE VALIDITY OF ANY PATENTS.  EACH PARTY HEREBY
DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE RESEARCH, DEVELOPMENT,
MANUFACTURE OR COMMERCIALIZATION OF ANY COMPOUND OR PRODUCT, INCLUDING PURSUANT
TO THIS AGREEMENT, WILL BE SUCCESSFUL, THAT ANY REGULATORY APPROVAL OR MARKETING
APPROVAL WILL BE OBTAINED, OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT TO
ANY COMPOUND OR PRODUCT WILL BE ACHIEVED.  EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, TESARO MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO ANY
PRODUCT, COMPONENT OR ACTIVE PHARMACEUTICAL INGREDIENT CONTROLLED BY COMPANY OR
A THIRD PARTY (FOR CLARITY, EXCLUDING A COMPOUND (AS DEFINED IN SECTION 1.30))
THAT COMPANY INCORPORATES INTO A COMBINATION PRODUCT.

ARTICLE 11

CONFIDENTIALITY 

11.1Nondisclosure and Nonuse.     

(a)Each Party (the “Receiving Party”) shall (and shall cause its Affiliates to),
during the Term and for a period of five (5) years thereafter, (i) maintain all
Confidential Information of the other Party (the “Disclosing Party”) in trust
and confidence, (ii) not disclose any such Confidential Information to any Third
Party without the prior written consent of the Disclosing Party, except as
expressly provided hereunder, and (iii) not use any such Confidential
Information for any purpose except and only to the extent required to perform
its obligations under, and exercise its rights under, this
Agreement.  Notwithstanding anything to the contrary in the foregoing, the
obligations of confidentiality and non-use with

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[***] 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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respect to any trade secret within such Confidential Information shall survive
such five (5) year period for so long as such Confidential Information remains
protected as a trade secret under Applicable Law.

(b)Each Party will (and will cause its Affiliates to) use at least the same
standard of care as it uses to protect its own Confidential Information of a
similar nature to prevent unauthorized disclosures or uses of Confidential
Information of the other Party, but no less than reasonable care. 

(c)If any information is expressly deemed to be Confidential Information of each
Party under this Agreement: (i) Company’s maintenance, use and disclosure of
such information shall be subject to the provisions of this ARTICLE 11
applicable to Confidential Information of TESARO; and (ii) TESARO’s maintenance,
use and disclosure of such information shall be subject to the provisions of
this ARTICLE 11 applicable to Confidential Information of Company.  If any
information is both expressly deemed to be Confidential Information of TESARO
only under this Agreement and described in clause (a) of the definition of
“Confidential Information,” it shall be treated as Confidential Information of
TESARO only.  If any information is both expressly deemed to be Confidential
Information of Company only under this Agreement and described in clause (a) of
the definition of “Confidential Information,” it shall be treated as
Confidential Information of Company only.

11.2Exceptions.    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 evidence:

(a)is publicly disclosed by the Disclosing Party, either before or after it is
disclosed to the Receiving Party hereunder;

(b)is known to the Receiving Party or any of its Affiliates, without any
obligation to keep it confidential or any restriction on its use, in each case,
to the Disclosing Party, prior to disclosure to the Receiving Party or any of
its Affiliates by the Disclosing Party;

(c)is subsequently disclosed to the Receiving Party or any of its Affiliates on
a non-confidential basis by a Third Party that, to the Receiving Party’s
Knowledge, is not bound by a similar duty of confidentiality or restriction on
its use, in each case, to the Disclosing Party;

(d)is now, or hereafter becomes, through no act or failure to act on the part of
the Receiving Party or any of its Affiliates in violation of this Agreement,
generally known or available, either before or after it is disclosed to the
Receiving Party by the Disclosing Party;

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[***] 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)is independently discovered or developed by or on behalf of the Receiving
Party or any of its Affiliates without the use of or reference to the
Confidential Information belonging to the Disclosing Party; or

(f)is the subject of written permission to disclose provided by the Disclosing
Party.

11.3Authorized Disclosure.    The Receiving Party may disclose Confidential
Information belonging to the Disclosing Party only to the extent such disclosure
is reasonably necessary in the following instances:

(a)filing, prosecuting, maintaining, enforcing or defending Patents as permitted
by this Agreement;

(b)as reasonably required in generating Regulatory Documentation, and obtaining
Regulatory Approvals, with respect to the Compounds and Products;

(c)prosecuting or defending litigation, including responding to a subpoena in a
Third Party litigation;

(d)complying with Applicable Law or court or administrative orders, including as
contemplated by Section 4.2(e);

(e)complying with any obligation under this Agreement; provided,  however, that
TESARO shall not disclose any Confidential Information of Company pursuant to a
TESARO License Agreement except to the extent expressly permitted by another
provision of this Agreement; or 

(f)to its Affiliates, sublicensees or prospective sublicensees, subcontractors
or prospective subcontractors, consultants, agents and advisors on  a
“need-to-know” basis in order for the Receiving Party to exercise its rights or
fulfill its obligations under this Agreement, each of whom prior to disclosure
must be bound by obligations of confidentiality and restrictions on use of such
Confidential Information that are no less restrictive than those set forth in
this ARTICLE 11; provided,  however, that, in each of the above situations, the
Receiving Party shall remain responsible for any failure by any Person who
receives Confidential Information pursuant to this Section 11.3(f) to treat such
Confidential Information as required under this ARTICLE 11.

If and whenever any Confidential Information is disclosed in accordance with
this Section 11.3, such disclosure shall not cause any such information to cease
to be Confidential Information except to the extent that such disclosure results
in a public disclosure of such information (other than by breach of this
Agreement).  Notwithstanding the foregoing, in the event a Party is required to
make a disclosure of the other Party’s Confidential Information pursuant to
Section 11.3(a) through Section 11.3(e), it will, except where impracticable or
not legally permitted, give reasonable

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[***] 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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advance notice to the other Party of such disclosure and use not less than the
same efforts to secure confidential treatment of such information as it would to
protect its own confidential information from disclosure. 

11.4Terms of this Agreement.    The Parties acknowledge that this Agreement and
all of the respective terms of this Agreement shall be treated as Confidential
Information of both Parties, subject to the provisions of Sections 11.3(f) and
11.6.

11.5Publicity.    Each Party may, but is not obligated to, make a public
announcement of the execution of this Agreement, which shall be issued at a time
and in a form to be mutually agreed by the Parties, but no later than four (4)
days after the Effective Date.  Except as required to comply with Applicable
Law, each Party agrees not to issue any other press release or other public
statement disclosing other information relating to this Agreement or the
transactions contemplated hereby without the prior written consent of the other
Party, such consent not to be unreasonably withheld, delayed or conditioned.    

11.6Securities Filings.  Notwithstanding anything to the contrary in this
ARTICLE 11, in the event either Party proposes to file with the Securities and
Exchange Commission or the securities regulators of any state or other
jurisdiction a registration statement or any other disclosure document that
describes or refers to the terms and conditions of this Agreement or any related
agreements between the Parties, or requires the filing of this Agreement as an
exhibit to such registration, statement or disclosure document, such Party shall
notify the other Party of such intention and shall provide the other Party with
a copy of relevant portions of the proposed filing at least 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 that refer to the other Party or the terms and conditions of this
Agreement or any related Agreements between the Parties.  The Party making such
filing shall cooperate in good faith with the other Party to obtain confidential
treatment of the terms and conditions of this Agreement or any related
Agreements between the Parties that the other Party reasonably requests be kept
confidential or otherwise afforded confidential treatment, and shall only
disclose Confidential Information that it is advised by outside counsel is
legally required to be disclosed.  Each Party acknowledges that the other Party
may be required by securities regulators, including the Securities and Exchange
Commission, or advised by such other Party’s outside counsel that the financial
terms, including the milestone amounts or royalty rates must be included in such
filings.  No notice shall be required under this Section 11.6 if the description
of or reference to this Agreement or a related agreement between the Parties
contained in the proposed filing has been included in any previous filing made
by either Party in accordance with this Section 11.6 or otherwise approved by
the other Party.    

11.7Relationship to Confidentiality Agreement and Merck License Agreement.  This
Agreement supersedes the Prior CDA; provided,  however, that (a) all
“Confidential Information” disclosed or received by the Parties and their
Affiliates thereunder shall be deemed Confidential Information hereunder and
shall be subject to the terms and conditions of this Agreement, and (b)
notwithstanding anything in this Agreement to the contrary, Section 10 of the
Prior CDA

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[***] 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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shall remain in effect in accordance with its terms unless a later signed
agreement between the Parties containing a standstill provision specifically
supersedes Section 10 of the Prior CDA by specific reference to it.  If any
terms of Article 9 of the Merck License Agreement are in conflict with, or more
restrictive than, the terms set forth in this ARTICLE 11, the terms of Article 9
of the Merck License Agreement shall prevail with respect to any of Merck’s
Proprietary Information (as such term is defined in the Merck License Agreement)
that is disclosed by TESARO or Merck to Company and marked as Merck’s
“confidential” or “proprietary” information (or, if communicated to Company
orally, if such information is designated as Merck’s “confidential” or
“proprietary” information at the time of disclosure and reduced to writing,
marked as “confidential” or “proprietary” to Merck and delivered to Company
within ten (10) Business Days from such disclosure). 

11.8Equitable Relief.    Given the nature of the Confidential Information and
the competitive damage that could result to a Party upon unauthorized
disclosure, use or transfer of its Confidential Information to any Third Party,
the Parties agree that monetary damages may not be a sufficient remedy for any
breach of this ARTICLE 11.  In addition to all other remedies, a Party shall be
entitled to seek specific performance and injunctive and other equitable relief
as a remedy for any breach or threatened breach of this ARTICLE 11. 

11.9Publications.   Each Party shall have the right to publish results of all
Clinical Trials that it conducts with respect to a Compound or a Product
pursuant to this Agreement, subject to ten (10) days prior review by the other
Party for issues of patentability and protection of its Confidential
Information, in a manner consistent with Applicable Laws and industry
practices.  The JDC shall establish a publication strategy with respect to other
publications relating to the Compounds and Products, and shall discuss and
oversee the review of such publications.

11.10Return of Confidential Information.  Upon expiration or termination of this
Agreement, each Party will use reasonably diligent efforts (including a
reasonably diligent search of files and computer storage devices) to return or
destroy all Confidential Information of the other Party except to the extent
such Confidential Information is necessary to exercise any license or other
right surviving termination of this Agreement.  Additionally, each Party will be
allowed to keep one archival copy of any Confidential Information of the other
Party for record keeping purposes only. 

ARTICLE 12

TERM AND TERMINATION

12.1Term.  This Agreement shall become effective as of the Effective Date and,
unless earlier terminated pursuant to this ARTICLE 12, shall continue in full
force and effect as long as Company continues to Exploit the Compounds or the
Products in accordance with the terms and conditions of this Agreement (the
“Term”). 

12.2Termination upon Termination of the Merck License Agreement or Either
AstraZeneca License Agreement.   Company shall have the right to immediately
terminate this

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[***] 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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Agreement upon written notice to TESARO upon the termination of the Merck
License Agreement or either of the AstraZeneca License Agreements.

12.3Unilateral Termination by Company.   Company shall have the right to
terminate this Agreement in its entirety at any time after the first anniversary
of the Effective Date, for any or no reason, upon providing ninety (90) days’
prior written notice to TESARO.    

12.4Termination for Material Breach.    

(a)Either Party (the “Terminating Party”) may terminate this Agreement in its
entirety, or on a country-by-country basis, in the event the other Party (the
“Breaching Party”) has materially breached this Agreement, and such material
breach has not been cured within one hundred eighty (180) days after receipt of
written notice of such breach by the Breaching Party from the Terminating Party
(the “Cure Period”).  The written notice describing the alleged material breach
shall provide sufficient detail to put the Breaching Party on notice of such
material breach. Any termination of this Agreement pursuant to this Section
12.4(a) shall become effective at the end of the Cure Period, unless the
Breaching Party has cured any such material breach prior to the expiration of
such Cure Period (or, if such material breach is reasonably able to be cured
within the Cure Period, the Breaching Party has notified the Terminating Party
of its plan for curing such and has commenced and sustained its efforts to cure
such material breach during the Cure Period).  The right of either Party to
terminate this Agreement as provided in this Section 12.4(a) shall not be
affected in any way by such Party’s waiver of or failure to take action with
respect to any previous breach under this Agreement. 

(b)If the Parties reasonably and in good faith disagree as to whether there has
been a material breach or a cure thereof, the Party that disputes whether there
has been a material breach or a cure may contest the allegation in accordance
with ARTICLE 13.  Notwithstanding anything to the contrary contained in Section
12.4(a), the Cure Period for any material breach that is the subject of a
Dispute will run from the date that written notice was first provided to the
Breaching Party by the Terminating Party through the resolution of such Dispute
pursuant to ARTICLE 13 and for ten (10) days thereafter, and it is understood
and acknowledged that, during the pendency of a Dispute pursuant to this Section
12.4(b), all of the terms and conditions of this Agreement shall remain in
effect, and the Parties shall continue to perform all of their respective
obligations under this Agreement, except that all payment obligations from one
Party to the other Party under this Agreement which are subject to the Dispute
shall be tolled until the resolution of such Dispute in accordance with ARTICLE
13.

12.5Termination by Company for Safety Reasons.  Company shall have the right to
terminate this Agreement, at any time after the Effective Date, at any time upon
providing thirty

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[***] 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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(30) days’ prior written notice to TESARO:  (a) if senior executives responsible
for Company’s pharmacovigilance and clinical science functions determine in good
faith that the risk/benefit profile of any Product is such that the Product
cannot continue to be Developed or administered to patients safely; or (b) upon
the occurrence of serious adverse events related to the use of a Product that
cause Company to conclude that the continued use of such Product by patients
will result in patients being exposed to a product in which the risks outweigh
the benefits.    

12.6[Reserved.] 

12.7Termination for Bankruptcy.    

(a)Either Party may terminate this Agreement in its entirety upon providing
written notice to the other Party on or after the time that such other Party
makes a general assignment for the benefit of creditors, files an insolvency
petition in bankruptcy, petitions for or acquiesces in the appointment of any
receiver, trustee or similar officer to liquidate or conserve its business or
any substantial part of its assets, commences under the laws of any jurisdiction
any proceeding involving its insolvency, bankruptcy, reorganization, adjustment
of debt, dissolution, liquidation or any other similar proceeding for the
release of financially distressed debtors, or becomes a party to any proceeding
or action of the type described above (each, an “Insolvency Event”), and such
proceeding or action remains un-dismissed or un-stayed for a period of more than
ninety (90) days.

(b)All rights and licenses granted under or pursuant to this Agreement,
including, for the avoidance of doubt, the licenses granted to Company pursuant
to Section 3.1, are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of Title 11 of the U.S. Code and other similar laws in any
jurisdiction outside the U.S. (collectively, the “Bankruptcy Laws”), licenses of
rights to “intellectual property” as defined under the Bankruptcy Laws.  Upon
the occurrence of any Insolvency Event with respect to a Party (the “Insolvent
Party”), the Insolvent Party agrees that the other Party (the “Non-Insolvent
Party”), as licensee of such rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the Bankruptcy
Laws.  Further, each Party agrees and acknowledges that all payments hereunder,
other than the payments pursuant to Section 8.4, do not constitute royalties
within the meaning of Section 365(n) of the Bankruptcy Code or relate to
licenses of intellectual property hereunder.  Each Party shall, during the Term,
create and maintain current copies or, if not amenable to copying, detailed
descriptions or other appropriate embodiments, to the extent feasible, of all
such intellectual property (TESARO Technology in the case of TESARO and Company
Technology in the case of Company).  Each Party agrees and acknowledges that
“embodiments” of intellectual property within the meaning of Section 365(n)
include, without limitation, laboratory notebooks, cell lines, product samples
and inventory, research studies and data, and Regulatory Documentation in each
case to the extent related to the Compounds and Products.

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[***] 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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If (i) a case is commenced during the Term by or against a Party under the
Bankruptcy Laws, (ii) this Agreement is rejected as provided for under the
Bankruptcy Laws, and (iii) the Non-Insolvent Party elects to retain its rights
hereunder as provided for under the Bankruptcy Laws, then the Insolvent
Party  (in any capacity, including debtor-in-possession) and its successors and
assigns (including a Title 11 trustee), shall (x) provide to the Non-Insolvent
Party immediately upon the Non-Insolvent Party’s written request copies of all
such intellectual property (including embodiments thereof) held by the Insolvent
Party and such successors and assigns, or otherwise available to them, and (y)
not interfere with the Non-Insolvent Party’s rights under this Agreement, or any
related agreements between the Parties, to such intellectual property (including
such embodiments), including any right to obtain such intellectual property (or
such embodiments) from another entity, to the extent provided in the Bankruptcy
Laws.  Whenever the Insolvent Party or any of its successors or assigns provides
to the Non-Insolvent Party any of the intellectual property licensed hereunder
(or any embodiment thereof) pursuant to this Section 12.7(b), the Non-Insolvent
Party shall have the right to perform the Insolvent Party’s obligations
hereunder with respect to such intellectual property, but neither such provision
nor such performance by the Non-Insolvent Party shall release the Insolvent
Party from liability resulting from rejection of the license or the failure to
perform such obligations.  All rights, powers and remedies of the Non-Insolvent
Party as provided herein are in addition to and not in substitution for any and
all other rights, powers and remedies now or hereafter existing at law or in
equity (including the Bankruptcy Laws) in the event of the commencement of a
case by or against a Party under the Bankruptcy Laws.  In particular, it is the
intention and understanding of the Parties to this Agreement that the rights
granted to the Parties under this Section 12.7 are essential to the Parties’
respective businesses and the Parties acknowledge that damages are not an
adequate remedy.  The Parties agree that they intend the following rights to
extend to the maximum extent permitted by Applicable Law, and to be enforceable
under Section 365(n) of Title 11 of the U.S. Code: (A) the right of access to
any intellectual property (including embodiments thereof) of the Insolvent
Party, or any Third Party with whom the Insolvent Party contracts to perform an
obligation of the Insolvent Party under this Agreement, and, in the case of the
Third Party, which is necessary for the Exploitation of Compounds or Products;
and (B) the right to contract directly with any Third Party to complete the
contracted work upon failure of the Insolvent Party to comply with its
applicable obligations.

12.8[***] 

12.9Effects of Termination.  All of the following effects of termination are in
addition to the other rights and remedies that may be available to either of the
Parties under this Agreement and shall not be construed to limit any such rights
or remedies.  For purposes of this Section 12.8, the “Termination Notice Date”
shall be the date on which notice of termination is given in

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[***] 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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accordance with this ARTICLE 12 and the “Termination Effective Date” shall be
the date on which termination becomes effective pursuant to this ARTICLE 12 (or,
if later, the effective date of termination specified in the termination
notice).    

(a)Consequences of Termination by TESARO or Company.  Upon termination of this
Agreement for any reason, the provisions of this Section 12.9(a) shall apply.  
 

(i)From and after the Termination Effective Date, all rights and licenses
granted by TESARO to Company will terminate, and Company and its Affiliates and
sublicensees will cease all use of TESARO Technology and TESARO Trademarks and
all Exploitation of Products, except to the extent necessary for Company to
perform its obligations under this Section 12.9(a).  Any sublicense granted by
Company or its Affiliates pursuant to Section 3.1(c) shall terminate on the
Termination Effective Date; provided,  however, any such sublicense shall, at
the request of TESARO prior to the Termination Effective Date, be assigned to
TESARO to the extent possible under the terms of the applicable sublicense and
to the extent that the applicable sublicense solely relates to Single Agent
Products, subject to the applicable sublicensee’s prior written consent.  In the
event that (A) TESARO does not request assignment of any such sublicense prior
to the Termination Effective Date, (B) the applicable sublicensee does not
consent to assignment or (C) any such sublicense does not solely relate to
Single Agent Products, then such sublicense shall terminate concurrently with
termination of Company’s rights under this Agreement.

(ii)From and after the Termination Effective Date, Company hereby grants to
TESARO a non-exclusive, worldwide, fully-paid, royalty-free, non-transferable
license, with the right to freely sublicense, under the Single Agent Technology
for the sole purpose of Exploiting the Reverted Single Agent Products; provided,
 however, that if any such Single Agent Technology is in-licensed from a Third
Party and subject to payment obligations to such Third Party, Company shall
disclose such obligations to TESARO in writing promptly following the
Termination Effective Date and such Single Agent Technology shall be subject to
the license granted in this Section 12.9(a)(ii) only if TESARO agrees in writing
to reimburse all amounts owed to such Third Party as a result of TESARO’s
exercise of such license.  For clarity, the foregoing license grant by Company
does not include any grant of rights under the Company Technology to Exploit any
active pharmaceutical compound that is not a Compound.  For purposes of this
Section 12.9(a): (A) “Single Agent Technology” means any Company Know-How that
solely relates to a Reverted Single

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[***] 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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Agent Product, any safety data Controlled by Company as of the Termination
Effective Date that is necessary for TESARO to Exploit a Reverted Single Agent
Product and any Company Patent that Covers a Reverted Single Agent Product; and
(B) “Reverted Single Agent Product” means a Single Agent Product that was in
active Development or being Commercialized in the Company Field prior to the
Termination Effective Date. 

(iii)Promptly following the Termination Effective Date, Company shall promptly
assign and transfer (or cause to be assigned and transferred) to TESARO any
Regulatory Approval (or application therefor) held by or on behalf of Company
that solely relates to a Reverted Single Agent Product in the Company Field (a
“Single Agent Regulatory Approval”), and shall take such actions and execute
such other instruments, assignments and documents as may be necessary to effect
the transfer of all Single Agent Regulatory Approvals to TESARO; provided,
 however, that Company shall be permitted to retain any Single Agent Regulatory
Approval to the extent, and for so long after the Termination Effective Date as,
necessary for Company to perform its obligations under this Section 12.9(a).  If
Applicable Law prevents or delays the transfer of ownership of any Single Agent
Regulatory Approval to TESARO, or Company retains any Single Agent Regulatory
Approval after the Termination Effective Date to perform its obligations under
this Section 12.9(a), Company hereby grants to TESARO an exclusive and
irrevocable right of access and reference to such Single Agent Regulatory
Approval, and shall cooperate fully to make the benefits of such Single Agent
Regulatory Approval available to TESARO. 

(iv)Promptly following the Termination Effective Date, Company shall withdraw
any Regulatory Approval (or application therefor) that solely relates to a
Combination Product or Combination Use in the Company Field.

(v)Promptly following the Termination Effective Date, Company shall provide to
TESARO copies of:  (A) all Single Agent Regulatory Approvals and any other
Regulatory Documentation Controlled by Company that solely relates to a Reverted
Single Agent Product; (B) any other Company Know-How that solely relates to a
Reverted Single Agent Product; and (C) any other Know-How Controlled by Company
on the Termination Effective Date that is not solely related to a Reverted
Single Agent Product, but that is necessary for TESARO to Exploit a Reverted
Single Agent Product in the Company Field in the Company
Territory.  Notwithstanding anything to the contrary in ARTICLE 11, TESARO shall
be free to use and disclose such Single Agent Regulatory Approvals, Regulatory
Documentation and Know-How in connection with the

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[***] 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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Exploitation of the Reverted Single Agent Products anywhere in the world.

(vi)At TESARO’s request prior to the Termination Effective Date, Company shall,
with respect to any Single Agent Agreement, use reasonable efforts to (A) if
assignment is permitted under such Single Agent Agreement, assign such Single
Agent Agreement to TESARO; or (B) if assignment is not permitted under such
Single Agent Agreement, grant to TESARO other rights to provide to TESARO the
benefit of such Single Agent Agreement, at TESARO’s expense (to the extent
mutually agreed), to the extent permitted under the terms of such Single Agent
Agreement.  For purposes of this Section 12.9(a)(vi), “Single Agent Agreement”
means any Third Party agreement to which Company or any of its Affiliates are a
party that solely relates to the Exploitation of Reverted Single Agent Products
in the Company Field in the Company Territory (including agreements for sale,
promotion, distribution or use of a Reverted Single Agent Product in the Company
Field in the Company Territory).

(vii)At TESARO’s request within [***] after the Termination Effective Date,
Company shall transfer to TESARO any inventory of Compound API or Reverted
Single Agent Product in the possession of Company or any of its Affiliates, at a
cost equal to Manufacturing Cost [***]. 

(viii)If Company is conducting any Clinical Trials with respect to a Reverted
Single Agent Product on the Termination Notice Date, TESARO shall elect to
either (A) have Company wind-down or complete such Clinical Trial or (B) have
responsibility for such Clinical Trial transferred to TESARO.  TESARO shall make
such election within [***] following the Termination Notice Date and, if TESARO
fails to make such election prior to the expiration of such [***] period, then
TESARO shall be deemed to have made the election described in clause (A).  If
TESARO elects to have Company wind-down or complete a Clinical Trial, then
Company shall wind-down or complete such Clinical Trial in its sole discretion
[***].  If TESARO elects to have such Clinical Trial transferred to TESARO, then
the Parties shall develop a plan to transition such Clinical Trial as soon as
practicable following the Termination Notice Date and [***].

(ix)If Company is conducting any Clinical Trials with respect to a Combination
Product on the Termination Notice Date, Company shall wind-down or complete such
Clinical Trial in accordance with Applicable Laws in its sole discretion
[***].  

(b)Consequences of Termination for Safety Reasons.  Upon termination of this
Agreement by Company pursuant to Section 12.5, the provisions of Section

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[***] 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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12.9(a) shall apply; provided,  however, that Company shall not be obligated to
transfer assets to TESARO pursuant to Section 12.9(a) to the extent Company
reasonably determines that the use of such assets in the continued Development
of the Compounds or Products by TESARO following the Termination Effective Date
would expose Company to additional Losses unless TESARO agrees to indemnify
Company for Losses arising from TESARO’s use of such assets following the
Termination Effective Date on the terms set forth in Section 14.2.  Immediately
upon such agreement, Company shall transfer those assets that were not
previously transferred to TESARO pursuant to this Section 12.9(b).    

12.10Remedies.  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.  Each Party shall be free,
pursuant to ARTICLE 13, to seek, without restriction as to the number of times
it may seek, damages, costs and remedies that may be available to it under
Applicable Law or in equity and shall be entitled, following final resolution of
a Dispute in accordance with ARTICLE 13, to offset the amount of any damages and
costs awarded pursuant to a final determination under Section 13.3 against any
amounts due to such other Party under this Agreement.

12.11Survival.  In the event of termination or expiration of this Agreement, in
addition to the provisions of this Agreement that continue in effect in
accordance with their terms, the following provisions of this Agreement shall
survive: ARTICLE 1 (Definitions) (as applicable), ARTICLE 11 (Confidentiality),
ARTICLE 12 (Term and Termination), ARTICLE 13 (Dispute Resolution), ARTICLE 14
(Indemnification) (solely as to activities arising during the Term or as to any
activities conducted in the course of a Party’s exercise of a license surviving
the Term), ARTICLE 15 (Miscellaneous); Sections 3.5 (No Implied Licenses),
4.2(g) (Ownership of Development Information and Results), 4.5 (Records), 5.9(d)
(Recall Records), 6.2(c)(iv), 6.4(a) (last sentence only), 6.6 (Transparency
Reporting), 8.5 (Royalty Term), 8.10 (Taxes), 8.11 (Audit), 8.15 (Late Payment),
9.1 (Ownership of Inventions), Section 9.2 (Disclosure of Inventions) and 10.6
(No Other Representations or Warranties); and any other provisions of this
Agreement that are necessary to interpret or effectuate the intent of the
foregoing provisions. 

ARTICLE 13

DISPUTE RESOLUTION

13.1Exclusive Dispute Resolution Mechanism.    The Parties recognize that a
dispute may arise out of or in relation to or in connection with this Agreement,
including any alleged failure to perform, or breach, of this Agreement, or any
issue relating to the interpretation, application, enforcement, termination or
validity of this Agreement (except for any Deadlocked Committee Matters or as
determined by a Third Party expert pursuant to Section 3.2(a), each, a
“Dispute”).  The Parties agree that the procedures set forth in this ARTICLE 13
shall be the exclusive mechanism for resolving Disputes.  For the avoidance of
doubt, this ARTICLE 13 (including the right to pursue provisional remedies under
Section 13.4) shall not apply to any failure of a Joint Committee to reach
consensus on any matter within such Joint Committee’s responsibilities or

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[***] 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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any Deadlocked Committee Matter; provided, that a dispute regarding any of the
following shall constitute a Dispute hereunder: (a) whether a matter is within a
Joint Committee’s responsibilities; (b) whether a matter is a Deadlocked
Committee Matter; or (c) whether an exercise of final decision-making authority
is made in accordance with Section 2.1(d)(iv).  Any Dispute, including Disputes
that may involve Company Parent or Affiliates of any Party, shall be resolved in
accordance with this ARTICLE 13.

13.2Resolution by Executive Officers.    Except as otherwise provided in this
ARTICLE 13, in the event of any Dispute, the Parties shall first attempt in good
faith to resolve such Dispute by negotiation and consultation between
themselves.  In the event that such Dispute is not resolved on such basis within
fifteen (15) Business Days (unless otherwise agreed by the Parties), 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) Business Days after such notice is received (unless otherwise agreed
by the Parties).  Each Party may, in its discretion, seek resolution of any and
all Disputes that are not resolved under this Section 13.2 in accordance with
Section 13.3.    

13.3Arbitration.  If the Parties fail to resolve the Dispute pursuant to Section
13.2, and a Party desires to pursue resolution of the Dispute, the Dispute shall
be submitted by either Party for resolution in arbitration pursuant to the then
current CPR Non-Administered Arbitration Rules (“CPR Rules”) (www.cpradr.org),
except where they conflict with these provisions, in which case these provisions
control.  The arbitration will be held in New York, New York. All aspects of the
arbitration shall be treated as confidential.

(a)Arbitrators.

(i)The arbitrators will be chosen from the CPR Panel of Distinguished Neutrals,
unless a candidate not on such panel is approved by both Parties.  Each
arbitrator shall be a lawyer with at least fifteen (15) years’ experience with a
law firm or corporate law department of over twenty-five (25) lawyers or who was
a judge of a court of general jurisdiction.  To the extent that the Dispute
requires special expertise, the Parties will so inform CPR prior to the
beginning of the selection process. 

(ii)The arbitration tribunal shall consist of three arbitrators, of whom each
Party shall designate one in accordance with the “screened” appointment
procedure provided in CPR Rule 5.4.  The chair will be chosen in accordance with
CPR Rule 6.4.  If, however, the aggregate award sought by the Parties is less
than [***] dollars ($[***]) and equitable relief is not sought, a single
arbitrator shall be chosen in accordance with the CPR Rules. 

(iii)The Parties agree to select the arbitrator(s) within forty-five (45) days
of initiation of the arbitration. 

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[***] 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)Procedures. 

(i)The hearing will be concluded within nine (9) months after selection of the
arbitrator(s) and the award will be rendered within sixty (60) days of the
conclusion of the hearing, or of any post‑hearing briefing, which briefing will
be completed by both sides within forty-five (45) days after the conclusion of
the hearing.  In the event the Parties cannot agree upon a schedule, then the
arbitrator(s) shall set the schedule following the time limits set forth above
as closely as practical.

(ii)The hearing will be concluded in ten (10) hearing days or less.  Multiple
hearing days will be scheduled consecutively to the greatest extent possible.  A
transcript of the testimony adduced at the hearing shall be made and shall be
made available to each Party. 

(iii)The arbitrator(s) shall be guided, but not bound, by the CPR Protocol on
Disclosure of Documents and Presentation of Witnesses in Commercial Arbitration
 (www.cpradr.org) (“Protocol”).  The Parties will attempt to agree on modes of
document disclosure, electronic discovery, witness presentation, etc. within the
parameters of the Protocol.  If the Parties cannot agree on discovery and
presentation issues, the arbitrator(s) shall decide on presentation modes and
provide for discovery within the Protocol, understanding that the Parties
contemplate reasonable discovery.    

(iv)The arbitrator(s) shall decide the merits of any Dispute in accordance with
the law governing this Agreement, without application of any principle of
conflict of laws that would result in reference to a different law.  The
arbitrator(s) may not apply principles such as “amiable compositeur” or “natural
justice and equity.” 

(v)The arbitrator(s) are expressly empowered to decide dispositive motions in
advance of any hearing and shall endeavor to decide such motions as would a
United States District Court Judge sitting in the jurisdiction whose substantive
law governs.

(vi)The arbitrator(s) shall render a written opinion stating the reasons upon
which the award is based.  The Parties consent to the jurisdiction of the United
States District Court for the district in which the arbitration is held for the
enforcement of these provisions and the entry of judgment on any award rendered
hereunder.  Should such court for any reason lack jurisdiction, any court with
jurisdiction may act in the same fashion.

13.4Provisional Remedies.  Each Party has the right to seek from the appropriate
court provisional remedies such as attachment, preliminary injunction, replevin,
etc. to avoid irreparable harm, maintain the status quo, or preserve the subject
matter of a Dispute pending the

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[***] 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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resolution of the Dispute under this ARTICLE 13.  Rule 14 of the CPR Rules does
not apply to this Agreement. 

13.5Confidentiality.  Any and all activities conducted under this ARTICLE 13
shall be deemed Confidential Information of each of the Parties, and shall be
subject to ARTICLE 11 above.

ARTICLE 14

INDEMNIFICATION

14.1Indemnification by Company.  Company hereby agrees to defend, indemnify and
hold harmless TESARO and its Affiliates, and each of their respective directors,
officers, employees, agents and representatives (each, a “TESARO Indemnitee”)
from and against any and all claims, suits, actions, demands, liabilities,
expenses and/or losses, including reasonable legal expenses and attorneys’ fees
(collectively, the “Losses”), to which any TESARO Indemnitee may become subject
as a result of any claim, demand, action or other proceeding by any Third Party
(each, a “Proceeding”), to the extent such Losses arise directly or indirectly
out of: 

(a)the breach by Company of, or any inaccuracy in, any representation or
warranty made by Company in this Agreement;

(b)the breach by Company or any of its Affiliates of, or failure to perform or
comply with, any covenant or obligation of Company or any of its Affiliates set
forth in this Agreement;

(c)the gross negligence, willful misconduct or violation of Applicable Law by
Company or any of its Affiliates or sublicensees in connection with the exercise
of any rights granted to Company or any of its Affiliates, or the performance of
any obligations imposed on Company or any of its Affiliates, under this
Agreement;

(d)the Exploitation by Company or any of its Affiliates or (sub)licensees of the
Joint Inventions or Joint Patents in connection with any compound that is not a
Compound or any product that is not a Product;

(e)the Exploitation of any Compound or Product by Company or any of its
Affiliates or sublicensees in the Company Field in the Company Territory, except
to the extent resulting from the reasonable reliance of Company or such
Affiliate on safety information or Regulatory Documentation relating to any
Compound or Product provided to Company or any of its Affiliates by TESARO or
any of its Affiliates;

(f)the Exploitation of any Compound or Product by TESARO or any of its
Affiliates or sublicensees in the TESARO Field in the TESARO Territory, to the
extent resulting from the reasonable reliance of TESARO or such Affiliate on
safety

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[***] 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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information, Regulatory Documentation or other information relating to any
Compound or Product provided to TESARO or any of its Affiliates by Company or
any of its Affiliates;

(g)any Proceeding that arises from (or is alleged to arise from) personal injury
or death caused by (i) the use of a Single Agent Product in the Company Field or
(ii) the use of a Combination Product Developed by Company in the Company Field,
except, in each case ((i) and (ii)), to the extent arising from defective Single
Agent Product or Compound API Manufactured by TESARO (a “Company Product
Liability Proceeding”); or

(h)any Proceeding that arises out of an Infringement Claim that solely relates
to the use or sale of a Single Agent Product in the Company Field or an
Infringement Claim that relates to the use or sale of a Combination Product
Developed by Company in the Company Field (a “Company Infringement Proceeding”);
   

except, with respect to each of clauses (a) through (h) above, to the extent
such Losses arise directly or indirectly from any of the causes for which TESARO
is obligated to indemnify Company under Section 14.2. 

 

14.2Indemnification by TESARO.    TESARO hereby agrees to defend, indemnify and
hold harmless Company and its Affiliates, and each of their respective
directors, officers, employees, agents and representatives (each, a “Company
Indemnitee”) from and against any and all Losses to which any Company Indemnitee
may become subject as a result of any Proceeding, to the extent such Losses
arise directly or indirectly out of: 

(a)the breach by TESARO of, or any inaccuracy in, any representation or warranty
made by TESARO in this Agreement;

(b)the breach by any TESARO or any of its Affiliates of, or failure to perform
or comply with, any covenant or obligation of TESARO or any of its Affiliates
set forth in this Agreement;

(c)the gross negligence, willful misconduct or violation of Applicable Law by
TESARO or any of its Affiliates or (sub)licensees in connection with the
exercise of any rights granted to TESARO or any of its Affiliates, or the
performance of any obligations imposed on TESARO or any of its Affiliates, under
this Agreement;

(d)the Exploitation by TESARO or any of its Affiliates or (sub)licensees of the
Joint Inventions or Joint Patents in connection with any compound that is not a
Compound or any product that is not a Product;

(e)the Exploitation of any Compound or Product by TESARO or any of its
Affiliates or sublicensees in the TESARO Field in the TESARO Territory (or in
any field in

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[***] 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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any territory prior to the Effective Date), except to the extent resulting from
the reasonable reliance of TESARO or such Affiliate on safety information,
Regulatory Documentation or other information relating to any Compound or
Product provided to TESARO or any of its Affiliates by Company or any of its
Affiliates;

(f)the Exploitation of any Compound or Product by Company or any of its
Affiliates or sublicensees in the Company Field in the Company Territory, to the
extent resulting from the reasonable reliance of Company or such Affiliate on
safety information or Regulatory Documentation relating to any Compound or
Product provided to Company or any of its Affiliates by TESARO or any of its
Affiliates;

(g)any Proceeding that arises from (or is alleged to arise from) personal injury
or death caused by a Product that is not a Company Product Liability Proceeding;
or

(h)any Proceeding that arises out of an Infringement Claim that is not a Company
Infringement Proceeding (a “TESARO Infringement Proceeding”);  

except, with respect to each of clauses (a) through (h) above, to the extent
such Losses arise directly or indirectly from any of the causes for which
Company is obligated to indemnify TESARO under Section 14.1.

14.3Indemnification Procedures.    

(a)Notice.    Promptly after a TESARO Indemnitee or a Company Indemnitee (each,
an “Indemnitee”) receives notice of a pending or threatened Proceeding, such
Indemnitee shall give written notice of such Proceeding (an “Indemnification
Notice”) to the Party from whom the Indemnitee is entitled to receive
indemnification pursuant to Section 14.1 or 14.2, as applicable (the
“Indemnifying Party”).  Failure or delay in providing an Indemnification Notice
to the Indemnifying Party shall not relieve the Indemnifying Party of any
liability it may have to the Indemnitee with respect to the applicable
Proceeding, except and only to the extent that such failure or delay causes
actual harm to the Indemnifying Party with respect to such Proceeding.  The
Indemnification Notice shall specify, in reasonable detail, the Proceeding with
respect to which such Indemnitee or any other Person that is entitled to receive
indemnification from the same Indemnifying Party pursuant to Section 14.1 or
14.2 (collectively, “Related Indemnitees”)  intends to base a request for
indemnification or reimbursement under Section 14.1 or 14.2, as
applicable.  Failure to provide such reasonable detail in an Indemnification
Notice will not relieve the Indemnifying Party of any liability it may have to
the Indemnitee with respect to the applicable Proceeding, except and only to the
extent that such failure causes actual harm to the Indemnifying Party with
respect to such Proceeding.  The Indemnitee shall enclose with the
Indemnification Notice a copy of any papers served with respect to such
Proceeding.  Within thirty (30) days after receipt of an Indemnification

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[***] 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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Notice, the Indemnifying Party shall notify the Indemnitee whether the
Indemnifying Party desires to assume the defense of the applicable Proceeding.

(b)Control of Defense.   If, within thirty (30) days after receipt of an
Indemnification Notice, the Indemnifying Party (i) notifies the Indemnitee that
it desires to assume control of the applicable Proceeding and (ii) acknowledges
in writing an obligation to indemnify or reimburse fully the Indemnitee and its
Related Indemnitees for all Losses arising from the Proceeding for which it is
obligated to indemnify the Indemnitee under Section 14.1 or 14.2 as
applicable  (which acknowledgment shall not be deemed or construed as an
admission of liability, either under this ARTICLE 14 or otherwise), then,
subject to Section 9.6 and Section 14.3(d), the Indemnifying Party shall have
the right to defend, settle and otherwise dispose of such Proceeding; provided,
 however, that if the Indemnifying Party does not have the right to defend,
settle or otherwise dispose of such Proceeding, then the Parties shall confer
and negotiate in good faith to determine whether to enter into a joint defense
agreement pursuant to which the Parties shall allocate the respective rights and
obligations of the Parties with respect to the control of the Proceeding,
including whether to designate one of the Parties as the defending Party.  In
the event that there are two or more Indemnitees that are subject to the same
Proceeding, this Section 14.3(b) shall be construed to apply separately to such
Proceeding as it applies to each such Indemnitee, provided that the Parties
shall take account of such fact in connection with their negotiations pursuant
to this Section 14.3(b) with respect to the defense, control and settlement of
such Proceeding as it applies to each such Indemnitee.  Any out-of-pocket costs
and expenses (including reasonable attorneys’ fees) reasonably incurred by the
Indemnifying Party in connection with its control of a Proceeding shall
constitute Losses with respect to such Proceeding.

(c)Interim Control.  Unless and until the Parties determine which Party shall
defend, settle and otherwise dispose of a Proceeding in accordance with
Section14.3(b), the Indemnitee shall have the right to defend and control such
Proceeding, but shall not have the right to consent to the entry of any judgment
or enter into any settlement with respect to the Proceeding for which it would
be seeking indemnification without the prior written consent of the Indemnifying
Party (which consent shall not be unreasonably withheld, conditioned or
delayed).

(d)Control by the Defending Party.  If the Parties determine that either Party
shall defend, settle and otherwise dispose of a Proceeding (other than a Company
Infringement Proceeding or TESARO Infringement Proceeding) in accordance with
Section 14.3(b) (such Party, the “Defending Party”), then: (i) the other Party
may retain separate co-counsel at its sole cost and expense (from and after the
Defending Party’s assumption of control of the Proceeding) and participate in
the defense of the Proceeding but the Defending Party shall control the
investigation, defense and settlement thereof; (ii) the other Party will not
consent

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[***] 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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to the entry of any judgment or enter into any settlement with respect to the
Proceeding for which it would be seeking indemnification or reimbursement
hereunder without the prior written consent of the Defending Party (which
consent shall not be unreasonably withheld, conditioned or delayed); and (iii)
the Defending Party will not, without the prior written consent of the other
Party, consent to the entry of any judgment or enter into any settlement with
respect to the Proceeding, to the extent such judgment or settlement (A)
provides for equitable relief (or any other relief other than solely for money
damages) or liability or obligation that cannot be assumed and performed by the
Defending Party in full (without any recourse to the other Party and its Related
Indemnitees), or for any monetary relief that will not be fully discharged by
the Defending Party (without any recourse to the other Party and its Related
Indemnitees) concurrently with the effectiveness of such judgment or settlement,
provided that the other Party’s consent shall not be unreasonably withheld,
conditioned or delayed to the extent that the sole relief is monetary, (B) does
not effect a full and unconditional release of the other Party and its Related
Indemnitees with respect to all claims in such Proceeding (or the portion
thereof to which the judgment or settlement relates), or (C) contains an
admission of wrongdoing on the part of the other Party or its Related
Indemnitees.  The Parties shall act in good faith in responding to, defending
against, settling or otherwise dealing with such Proceeding, provided that (x)
an Indemnitee shall not be obligated pursuant to this sentence to enter into or
consent to the entry of any judgment or settlement in relation to any Proceeding
and (y) in any event, an Indemnifying Party shall not be relieved of its
obligations under this sentence as a result of any breach of this sentence
(determined after giving effect to clause (x)), except to the extent that the
Indemnifying Party is actually prejudiced by such breach.  Notwithstanding
anything to the contrary in this Agreement, an Indemnifying Party shall not be
entitled to assume the defense of any Proceeding that seeks an injunction or
other equitable relief (or any other relief other than solely money damages)
against the Indemnitee.  The Parties shall also cooperate in any such defense
and give each other reasonable access to all non-privileged information relevant
thereto to the extent permitted by Applicable Law.  Notwithstanding the
foregoing, the defense, settlement or other disposal of any Company Infringement
Proceeding or TESARO Infringement Proceeding shall be governed by the provisions
of Section 9.6.

(e)Election Not to Control.  If there is no Defending Party with respect to a
given Proceeding (other than a Company Infringement Proceeding or TESARO
Infringement Proceeding), then the Indemnitee will be entitled to assume control
of the Proceeding, at its cost and expense (or, to the extent the Indemnitee is
entitled to indemnification or reimbursement with respect thereto pursuant to
Section 14.1 or 14.2, at the expense of the other Party to such extent) upon
delivery of notice to such effect to the other Party, provided that the
Indemnifying Party shall have the right to participate in the Proceeding at its
sole cost and

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[***] 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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expense, but the Indemnitee shall control the investigation, defense and
settlement thereof.

(f)Unauthorized Settlements.  Whether or not the Indemnifying Party is the
Defending Party with respect to any Proceeding (other than a Company
Infringement Proceeding or TESARO Infringement Proceeding), the Indemnifying
Party shall not be obligated to indemnify or reimburse the Indemnitee hereunder
for any settlement entered into, or any judgment that was consented to, by the
Indemnitee with respect to such Proceeding without the Indemnifying Party’s
prior written consent (which consent shall not be unreasonably withheld,
conditioned or delayed).

(g)Certain Infringement Losses.  Notwithstanding Section 14.2(h), any Losses
that arise directly or indirectly out of a TESARO Infringement Proceeding that
relates to the use or sale of a Single Agent Product in both the Company Field
and TESARO Field in a given country shall be allocated between the Parties using
the same methodology that Net Sales of such Single Agent Product in such country
are allocated between the Parties in accordance with Exhibit 8.3.

(h)Allocations.  The allocation between the Parties (whether by indemnification,
reimbursement or otherwise) of any Losses, if not otherwise determined in a
court of law, shall be considered by the Parties and, if the Parties do not
reach agreement in writing on such allocation, either Party shall have the right
to refer the Dispute to dispute resolution pursuant to Section 13.1.  The
Parties, the Executive Officers or the arbitrator, as the case may be, shall
make such allocation based on the indemnification principles set forth in this
ARTICLE 14.  Notwithstanding the foregoing, the Parties shall not be entitled to
refer any Dispute with respect to Losses arising under a Proceeding pursuant to
this Section 14.3(h) to arbitration to the extent that the liability of either
Party for such Losses is being contested in such Proceeding (or any other
Proceeding that would be binding with respect to such first Proceeding).

(i)Third Party Rights.  The Parties shall attempt in good faith to reach
alignment with respect to the rights set forth in this Section 14.3, including
any rights with respect to the control of any applicable Proceeding, to take
into account the rights of any Third Party (e.g., a subcontractor of a Party)
that has an obligation to indemnify any Party (or its Related Indemnitees) with
respect to any Losses covered by this ARTICLE 14.

14.4Insurance.  At such time as Company or any of its Affiliates or sublicensees
begins to sell or distribute Products, Company shall, at its own expense,
procure and maintain product liability insurance in the amount of [***] Dollars
($[***]). All such policies shall name Merck as an additional insured, and
insurers will waive all rights of subrogation against Merck.  Company shall
notify TESARO not less than twenty five (25) days in advance of any material
change or

Confidential

126

 

 

[***] 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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cancellation of any policy.  Company shall continue to maintain such insurance
in effect after the expiration or termination of this Agreement during any
period in which Company or its sublicensees continue to make, have made, use,
sell, offer to sell or import Products.  If any insurance is on a claims made
basis, Company will maintain such insurance for a period of not less than five
(5) years after it has ceased all commercial sale, distribution or use of any
Product.  TESARO shall maintain the insurance amounts required by Section 11.06
of the Merck License Agreement.  Upon request, each Party shall promptly provide
the other Party with a certificate of insurance for itself and, in the case of
Company, its sublicensees, evidencing the coverage required under this Section
14.4 or Section 11.06 of the Merck License Agreement, as applicable.  Such
insurance shall not be construed to create a limit of a Party’s liability with
respect to its indemnification obligations under this ARTICLE 14.  The Parties
acknowledge and agree that Company may meet its obligations under this Section
14.4 through self-insurance.    

14.5Limitation of Liability.     EXCEPT WITH RESPECT TO BREACHES OF EACH PARTY’S
OBLIGATIONS UNDER ARTICLE 11, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY
FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, MULTIPLIED OR CONSEQUENTIAL DAMAGES
(INCLUDING FOR LOST PROFITS), WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT,
STRICT LIABILITY OR OTHERWISE, ARISING UNDER OR IN CONNECTION WITH THIS
AGREEMENT OR ANY ANCILLARY AGREEMENT.  NOTHING IN THIS SECTION 14.5 IS INTENDED
TO OR SHALL OPERATE TO LIMIT A PARTY’S OBLIGATIONS OF INDEMNITY OR REIMBURSEMENT
OF LOSSES UNDER THIS ARTICLE 14.

ARTICLE 15

MISCELLANEOUS

15.1Notices.  All notices and other communications given or made pursuant hereto
shall be in writing and shall be deemed to have been duly given on the date
delivered, if delivered personally, or on the next Business Day after being sent
by reputable overnight courier (with delivery tracking provided, signature
required and delivery prepaid), in each case, to the Parties at the following
addresses, or on the date sent and confirmed by electronic transmission to the
telecopier number specified below (or at such other address or telecopier number
for a Party as shall be specified by notice given in accordance with this
Section 15.1).

(a)If to Company:

Janssen Biotech, Inc.

800/850 Ridgeview Dr.

Horsham, PA 19044

Attention: President

Facsimile: [***] 

 

with copies (which shall not constitute notice) to:

Johnson & Johnson

Confidential

127

 

 

[***] 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.

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

 

 

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Attention: General Counsel, Pharmaceuticals

Facsimile: [***]  

 

(b)If to TESARO:

TESARO, Inc.

Attention: General Counsel

1000 Winter Street, Suite 3300

Waltham, MA  02451

Facsimile No.: (339) 469-8966

 

with copies (which shall not constitute notice) to:

Hogan Lovells US LLP

Attention: Asher M. Rubin

100 International Drive, Suite 2000

Baltimore, MD  21202

Facsimile No.: (410) 659-2701

 

15.2Governing Law.    This Agreement and all disputes arising out of or related
to this Agreement or any breach hereof shall be governed by and construed under
the laws of the State of New York, without giving effect to any choice of law
principles that would require the application of the laws of a different
jurisdiction.

15.3[***]

15.4Assignment.    The terms and provisions of this Agreement shall inure to the
benefit of, and be binding upon, the Parties and their respective successors and
permitted assigns.  Except as expressly permitted in this Agreement, neither
Party may, without the prior written consent of the other Party, assign or
otherwise transfer any of its rights and interests or subcontract or otherwise
delegate any of its obligations under this Agreement.  Notwithstanding the
foregoing, (a) either Party, without such consent, may assign its rights and
delegate its duties under this Agreement to an Affiliate that is a directly or
indirectly wholly-owned subsidiary of TESARO or Company Parent, as the case may
be, provided that such assignment or delegation to an Affiliate shall terminate
automatically at such time, if any, as such Affiliate ceases to be wholly-owned,
directly or indirectly, by TESARO or Company Parent, as the case may be and (b)
either Party, without such consent, may assign this Agreement to an Affiliate
that is directly or indirectly controlled by TESARO or Company Parent, as the
case may be (as the term “controlled by” is defined in Section 1.2), provided
that such assignment to an Affiliate shall terminate automatically at such time,
if any, as such Affiliate ceases to be directly or indirectly controlled by
TESARO or Company Parent, as the case may be.  The Parties acknowledge and agree
that a

Confidential

128

 

 

[***] 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.

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

 

 

Change of Control transaction of the type described in clause (a), (b), (c) or
(d) of the definition of “Change of Control” shall not be deemed to be an
assignment of this Agreement for purposes of this Section 15.4.  Either Party
may, without the consent of the other Party, assign this Agreement in its
entirety to an Acquirer pursuant to a Change of Control transaction of the type
described in clause (e) of the definition of “Change of Control” if such
Acquirer agrees in writing to be bound by the terms and conditions of this
Agreement.  Any purported assignment, transfer, subcontract or delegation by
either Party in violation of the terms of this Section 15.4 shall be null and
void and of no legal effect.   

 

15.5Designation of Affiliates.    Each Party may discharge any obligation and
exercise any right hereunder through delegation of its obligations or rights to
any of its Affiliates.  Each Party hereby guarantees the performance by its
Affiliates of such Party’s obligations under this Agreement, and shall cause its
Affiliates to comply with the provisions of this Agreement in connection with
such performance.  Any breach by a Party’s Affiliate of any of such Party’s
obligations under this Agreement shall be deemed a breach by such Party, and the
other Party may proceed directly against such Party without any obligation to
first proceed against such Party’s Affiliate. 

15.6Relationship of the Parties.    It is expressly agreed that TESARO, on the
one hand, and Company, on the other hand, are independent contractors, and it is
further agreed that the Parties fully intend and expect that the relationship
between the two Parties shall not constitute a partnership, joint venture or
agency.  Except as expressly provided herein, neither TESARO nor Company shall
have the authority to make any statements, representations or commitments of any
kind, or to take any action which shall be binding on the other, without the
prior written consent of the other Party to do so.  All individuals employed by
a Party shall be employees of that Party and not of the other Party and all
costs and obligations incurred by reason of such employment shall be for the
account and expense of such Party.

15.7Force Majeure.    Both Parties shall be excused from the performance of
their obligations under this Agreement to the extent that such performance is
prevented by Force Majeure and the nonperforming Party promptly provides notice
of such Force Majeure circumstances to the other Party.  Such excuse shall be
continued so long as the condition constituting Force Majeure continues and the
nonperforming Party takes reasonable efforts to remove the
condition.  Notwithstanding the foregoing, a Party shall not be excused from
making payments owed hereunder because of a Force Majeure affecting such
Party.  If a Force Majeure persists for more than ninety (90) days, then the
Parties shall discuss in good faith the modification of the Parties’ obligations
under this Agreement in order to mitigate the delays caused by such Force
Majeure.  In the event a Party is prevented from performing its obligations
under this Agreement due to Force Majeure for more than six (6) months according
to this Section 15.7, the other Party shall have the right to terminate this
Agreement upon sixty (60) days’ notice after the expiration of such period.  A
termination under this Section 15.7 by either Party shall be treated as a
termination under Section 12.4 and the corresponding provisions for termination
under Section 12.9(a) shall apply.

Confidential

129

 

 

[***] 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.

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

 

 

15.8Entire Agreement; Amendments.    This Agreement, including the Exhibits
hereto, sets forth the complete, final and exclusive agreement and all the
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties with respect to the subject matter hereof and
supersedes, as of the Effective Date, all prior and contemporaneous agreements
and understandings between the Parties with respect to the subject matter
hereof, including the Prior CDA.  There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties with respect to the subject matter hereof other
than as are set forth herein and therein.  No subsequent alteration, amendment,
change or addition to this Agreement shall be binding upon the Parties unless
reduced to writing and signed by an authorized officer of each Party.  In the
event of any inconsistency between the body of this Agreement and any Exhibits
to this Agreement or any subsequent agreements ancillary to this Agreement,
unless otherwise express stated to the contrary in such Exhibit or ancillary
agreement, the terms contained in this Agreement shall control.  For the
avoidance of doubt, as between this Agreement and any supply agreement, quality
agreement or PVA entered into between the Parties following the Effective Date,
the terms and conditions of such supply agreement, quality agreement or PVA
shall govern and control with respect to the subject matter thereof.

15.9Severability.    If any one or more of the provisions of this Agreement is
held to be invalid or unenforceable by any court of competent jurisdiction from
which no appeal can be or is taken, the provision shall be considered severed
from this Agreement and shall not serve to invalidate any remaining provisions
hereof.  The Parties shall make good faith efforts 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.

15.10English Language.    This Agreement shall be written in and executed in,
and all other communications under or in connection with this Agreement shall be
in, the English language.  Any translation into any other language shall not be
an official version hereof or thereof, and in the event of any conflict in
interpretation between the English version and such translation, the English
version shall control.

15.11Waiver and Non-Exclusion of Remedies.    Any term or condition of this
Agreement may be waived at any time by the Party that is entitled to the benefit
thereof, but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the Party waiving such term or
condition.  The waiver by either Party of any right hereunder or of the failure
to perform or of a breach by the other Party shall not be deemed a waiver of any
other right hereunder or of any other breach or failure by such other Party
whether of a similar nature or otherwise.  The rights and remedies provided
herein are cumulative and do not exclude any other right or remedy provided by
Applicable Law or otherwise available except as expressly set forth herein.

15.12Further Assurance.    Each Party shall duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to
be done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as

Confidential

130

 

 

[***] 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.

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

 

 

may be necessary or as the other Party may reasonably request in connection with
this Agreement to carry out more effectively the provisions and purposes hereof.

15.13Headings.    The headings of each Article and Section in this Agreement
have been inserted for convenience of reference only and are not intended to
limit or expand on the meaning of the language contained in the particular
Article or Section.

15.14Construction.    Whenever this Agreement refers to a number of days without
using a term otherwise defined herein, such number refers to calendar days,
whether or not “calendar days” is expressly stated.  Except where the context
otherwise requires, (a) wherever used, the singular shall include the plural,
the plural shall include the singular; (b) the use of any gender shall be
applicable to all genders; (c) the terms “including,” “include,” “includes” and
“for example” shall not limit the generality of any description preceding such
term and, as used herein, shall have the same meaning as “including, but not
limited to,” and “including, without limitation”; (d) the words “herein”,
“hereof” and hereunder”, and words of similar import, refer to this Agreement in
its entirety and not to any particular provision hereof; (e) the word “will”
means “shall”; (f) if a period of time is specified and dates from a given day
or Business Day, or the day or Business Day of an act or event, it is to be
calculated exclusive of that day or Business Day; (g) “Dollar”, “USD” or “$”
means U.S. Dollars; (h) references to a particular Person include such Person’s
successors and assigns to the extent not prohibited by this Agreement; (i) a
capitalized term not defined herein but reflecting a different part of speech
than a capitalized term which is defined herein shall be interpreted in a
correlative manner; and (j) 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).  The language of
this Agreement shall be deemed to be the language mutually chosen by the Parties
and no rule of strict construction shall be applied against either Party.  Each
Party represents that it has been represented by legal counsel in connection
with this Agreement and acknowledges that it has participated in the drafting
hereof.

15.15Counterparts.    This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.  This Agreement may be
executed by .pdf or other electronically transmitted signatures and such
signatures shall be deemed to bind each Party as if they were the original
signatures.

SIGNATURE PAGE FOLLOWS

 

 

Confidential

131

 

 

[***] 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.

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

 

 

IN WITNESS WHEREOF, the Parties have signed this Agreement as of the date first
set forth above.

 

 

JANSSEN BIOTECH, INC.

 

 

By:

/s/ Scott White

 

 

 

 

Name:

Scott White

 

 

 

 

Title: 

VP Janssen Biotech, Inc.

 

 

 

 

 

 

TESARO, INC.

 

 

 

 

By:

/s/ Leon O. Moulder, Jr.

 

 

 

 

Name:

Leon O. Moulder, Jr.

 

 

 

 

Title:

CEO

 

 

 

[Signature Page to Collaboration and License Agreement]

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 1.63

Initial Compound

 

Niraparib, formerly known as MK-4827, licensed to TESARO under the Merck License
Agreement, a potent and selective poly (ADP-ribose) polymerase (PARP) inhibitor,
with the chemical name as follows: 

 

[***]

 

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 1.69

2016 Johnson & Johnson Universal Calendar

 

Picture 1 [tsro20160630ex101a241bc001.jpg]

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 1.117

TESARO Patents

 

Patent schedule for MK-4827 and MK-2512

 

(1) IRT-ONC-0121Y: Amide substituted indazole and benzotriazole derivatives as
poly(ADP-ribose)polymerase(PARP) inhibitors

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2007232297

02 April 2007

Granted

2007232297

03 January 2013

Canada

2647545

02 April 2007

Granted

2647545

23 February 2016

China P.R.

200780012001.6

02 April 2007

Granted

101415686

13 March 2013

European Patent Convention

07733600.6

02 April 2007

Allowed

 

 

India

8150/DELNP/08

02 April 2007

Pending

 

 

Japan

2009-503667

02 April 2007

Granted

4611441

22 October 2010

United States

13/091427

21 April 2011

Abandoned

 

 

 

(2) IRT-ONC-0121Y2:  Amide substituted indazoles as
poly(ADP-ribose)polymerase(PARP) inhibitors

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Albania

AL/P/2011/3701

08 January 2008

Granted

3755

23 March 2011

Algeria

090395

08 January 2008

Granted

6603

30 May 2011

Argentina

P080100061

08 January 2008

Granted

AR064777B1

23 April 2014

Armenia

200970674

08 January 2008

Granted

016079

30 January 2012

Australia

2008204380

08 January 2008

Granted

2008204380

28 November 2013

Austria

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Austria

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Azerbaijan

200970674

08 January 2008

Granted

016079

30 January 2012

Barbados

2001/1480

08 January 2008

Pending

 

 

Belarus

200970674

08 January 2008

Granted

016079

30 January 2012

Belgium

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Belgium

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Belize

587.09

08 January 2008

Granted

587.09

05 March 2010

Bermuda

418EP

08 January 2008

Granted

418P

26 September 2012

Bosnia-Herzegovina

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Brazil

PI0806245-5

08 January 2008

Pending

 

 

Bulgaria

08702101.0

08 January 2008

Granted

2109608

23 March 2011

 

Confidential

 

 

 

[***] 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.

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

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Canada

2674436

08 January 2008

Granted

2674436

17 July 2012

Chile

00046-2008

08 January 2008

Pending

48.598

03 May 2013

China P.R.

200880001926.5

08 January 2008

Granted

101578279

17 July 2013

Colombia

09068415

08 January 2008

Granted

2532

24 August 2012

Costa Rica

10910

08 January 2008

Granted

3180

23 March 2015

Croatia

08702101.0

08 January 2008

Granted

P20110447

23 March 2011

Cyprus

CY20111100595

08 January 2008

Granted

CY1111584

23 March 2011

Czech Republic

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Czech Republic

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Denmark

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Denmark

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Dominican Republic

P2009-0170

08 January 2008

Pending

 

 

Ecuador

SP-09-9484

08 January 2008

Pending

 

 

Egypt

PCT1065/2009

08 January 2008

Pending

 

 

El Salvador

2009003321

08 January 2008

Granted

20090008141

14 February 2011

Estonia

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Eurasian Patent Convention

200970674

08 January 2008

Granted

016079

30 January 2012

European Patent Convention

08702101.0

08 January 2008

Granted

2109608

23 March 2011

European Patent Convention

11157369.7

08 March 2011

Granted

2336120

16 July 2014

European Patent Convention

14176452.2

26 November 2014

Pending

 

 

Finland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Finland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

France

08702101.0

08 January 2008

Granted

2109608

23 March 2011

France

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Georgia

AP2008011413

08 January 2008

Granted

P5337

25 November 2011

Germany

08702101.0

08 January 2008

Granted

602008005711.9

23 March 2011

Germany

11157369.7

08 March 2011

Granted

602008033393.0

16 July 2014

Great Britain

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Great Britain

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Greece

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Greece

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Guatemala

A-2009-00190

08 January 2008

Granted

5761

05 May 2014

 

Confidential

 

 

 

[***] 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.

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

 

 

 

 

 

 

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Gulf Cooperation Council

2008/9897

05 January 2008

Pending

 

 

Honduras

2009-001260

08 January 2008

Granted

5355

08 March 2013

Hong Kong

09110676.1

08 January 2008

Granted

1131137

09 December 2011

Hong Kong

11108534.3

08 January 2008

Granted

1154386

06 February 2015

Hungary

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Iceland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

India

4674/DELNP/2009

08 January 2008

Granted

IN270342

14 December 2015

Indonesia

W00200901818

08 January 2008

Granted

IDP0030184

10 February 2012

Ireland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Ireland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Israel

199264

08 January 2008

Granted

199264

28 September 2013

Italy

502011901952934

08 January 2008

Granted

2109608

23 March 2011

Italy

502014000000867

08 March 2011

Granted

2336120

16 July 2014

Japan

2009-545240

08 January 2008

Granted

4611444

22 October 2010

Kazakhstan

200970674

08 January 2008

Granted

016079

30 January 2012

Korea South

10-2009-7014520

08 January 2008

Pending

 

 

Kyrgyzstan

200970674

08 January 2008

Granted

016079

30 January 2012

Latvia

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Lebanon

8156

08 January 2008

Granted

8156

22 September 2008

Lithuania

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Luxembourg

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Macao

J/001224

08 January 2008

Granted

J/00124

11 December 2013

Macedonia

P-2011/142

08 January 2008

Granted

2109608

23 March 2011

Malaysia

PI 20092876

08 January 2008

Granted

147789

31 January 2013

Malta

EP00300

08 January 2008

Granted

2109608

23 March 2011

Mexico

MX/a/2009/007200

08 January 2008

Granted

277664

29 July 2010

Moldova

200970674

08 January 2008

Granted

016079

30 January 2012

Mongolia

4314

08 January 2008

Granted

3334

25 October 2009

Morocco

PV32111

08 January 2008

Granted

31554

02 August 2010

Netherlands

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Netherlands

11157369.7

08 March 2011

Granted

2336120

16 July 2014

New Zealand

578256

08 January 2008

Granted

578256

02 April 2012

Nicaragua

2009-0135

08 January 2008

Pending

 

 

Norway

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Norway

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Pakistan

20/2008

08 January 2008

Pending

 

 

Peru

97

08 January 2008

Granted

6371

29 February 2012

Confidential

 

 

 

[***] 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.

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

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Philippines

1-2009-501286

08 January 2008

Granted

1-2009-501286

21 September 2012

Poland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Poland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Portugal

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Portugal

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Romania

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Russian Federation

200970674

08 January 2008

Granted

016079

30 January 2012

Serbia

P-236/2011

08 January 2008

Granted

51780

23 March 2011

Singapore

200904280-5

08 January 2008

Granted

153520

13 July 2012

Slovak Republic

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Slovak Republic

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Slovenia

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Solvenia

11157369.7

08 March 2011

Granted

2336120

16 July 2014

South Africa

2009/03898

08 January 2008

Granted

2009/03898

28 April 2010

Spain

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Spain

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Sweden

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Sweden

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Switzerland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Switzerland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Taiwan

097100730

08 January 2008

Pending

 

 

Tajikistan

200970674

08 January 2008

Granted

016079

30 January 2012

Thailand

0801000088

08 January 2008

Pending

 

 

Trinidad

TT/A/2009/00132

08 January 2008

Pending

 

 

Tunisia

TN2009/0286

08 January 2008

Granted

21034

20 September 2011

Turkey

2011/05543

08 January 2008

Granted

2011 05543

23 March 2011

Turkmenistan

200970674

08 January 2008

Granted

016079

30 January 2012

Ukraine

2009 08335

08 January 2008

Granted

97658

12 March 2012

United States

12/006993

08 January 2008

Granted

8071623

06 December 2011

Venezuela

2008-000029

08 January 2008

Pending

 

 

Vietnam

1-2009-01655

08 January 2008

Pending

 

 

 

Confidential

 

 

 

[***] 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.

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

 

 

 

(3) TER-ONC-1729: Pharmaceutically acceptable salts of
2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide

 

 

 

 

 

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2009203598

08 January 2009

Granted

2009203598

09 January 2014

Brazil

PI0906020-0

08 January 2009

Pending

 

 

Canada

2711491

08 January 2009

Pending

2653529

09 February 2016

China P.R.

200980101861.6

08 January 2009

Pending

 

 

European Patent Convention

09700579.7

08 January 2009

Granted

2240466

29 July 2015

France

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Germany

09700579.7

08 January 2009

Granted

602009032466.7

29 July 2015

Great Britain

09700579.7

08 January 2009

Granted

2240466

29 July 2015

India

4920/DELNP/2010

08 January 2009

Pending

 

 

Ireland

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Israel

206201

08 January 2009

Granted

206201

01 November 2011

Italy

502015000061194

08 January 2009

Granted

2240466

29 July 2015

Japan

2010-541101

08 January 2009

Pending

 

 

Korea South

10-2010-7015011

08 January 2009

Pending

 

 

Mexico

MX/a/2010/006593

08 January 2009

Pending

 

 

Netherlands

09700579.7

08 January 2009

Granted

2240466

29 July 2015

New Zealand

586675

08 January 2009

Granted

586675

06 August 2012

Russian Federation

2010133241

08 January 2009

Granted

2495035

10 October 2013

South Africa

2010/03902

08 January 2009

Granted

2010/03902

23 February 2011

Spain

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Switzerland

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Turkey

2015/13219

08 January 2009

Granted

2015 13219

29 July 2015

United States

12/811922

08 January 2009

Granted

8436185

07 May 2013

 

(4) IRT-ONC-0129: Pyridinone and pyridazinone derivatives as inhibitors of
poly(ADP-ribose)polymerase (PARP)

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2007266836

25 May 2007

Granted

2007266836

09 January 2014

Brazil

PI0711741-8

25 May 2007

Pending

 

 

Canada

2653529

25 May 2007

Pending

 

 

China P.R.

200780020136.7

25 May 2007

Pending

 

 

China P.R.

201310316726.1

25 July 2013

Pending

 

 

European Patent Convention

07733716.0

25 May 2007

Pending

 

 

India

9794/DELNP/2008

25 May 2007

Pending

 

 

Israel

195113

25 May 2007

Granted

195113

29 August 2014

Confidential

 

 

 

[***] 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.

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

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Japan

2009-512681

25 May 2007

Granted

5351755

30 August 2013

Korea South

10-2008-7029132

25 May 2007

Granted

10-1529891

12 June 2015

Mexico

MX/a/2008/015014

25 May 2007

Granted

311801

29 July 2013

New Zealand

572815

25 May 2007

Granted

572815

05 March 2012

Norway

2008 5397

25 May 2007

Pending

 

 

Russian Federation

2008152824

25 May 2007

Granted

2472782

20 January 2013

South Africa

2008/09238

25 May 2007

Granted

2008/09238

30 December 2009

United States

12/227513

25 May 2007

Granted

8188084

29 May 2012

 

(5) IRT-ONC-0152: Pyridazinone derivatives as PARP inhibitors

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2008322676

14 November 2008

Granted

2008322676

20 March 2014

Brazil

PI0820236-2

14 November 2008

Pending

 

 

Canada

2704714

14 November 2008

Pending

 

 

China P.R.

200880115590.5

14 November 2008

Granted

101855221

30 October 2013

European Patent Convention

08850429.5

14 November 2008

Granted

2220073

03 September 2014

France

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Great Britain

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Germany

08850429.5

14 November 2008

Granted

602008034267.0

03 September 2014

India

2638/CHENP/2010

14 November 2008

Pending

 

 

Israel

205142

14 November 2008

Granted

205142

31 December 2014

Italy

502014000002462

14 November 2008

Granted

2220073

03 September 2014

Japan

2010-533666

14 November 2008

Granted

5758630

12 June 2015

Korea South

10-2010-7013113

14 November 2008

Pending

 

 

Mexico

MX/a/2010/005070

14 November 2008

Granted

298063

12 April 2012

Netherlands

08850429.5

14 November 2008

Granted

2220073

03 September 2014

New Zealand

585395

14 November 2008

Granted

585395

09 July 2012

Russian Federation

2010123874

14 November 2008

Granted

2490265

20 August 2013

South Africa

2010/02466

14 November 2008

Granted

2010/02466

29 December 2010

Switzerland

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Spain

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Turkey

201414390

14 November 2008

Granted

2014 14390

03 September 2014

United States

12/739262

14 November 2008

Granted

8268827

18 September 2012

 

Confidential

 

 

 

[***] 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.

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

 

 

[***]

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 4.2(c)

TESARO Development Plan

 

A summary of ongoing and planned Phase 2 and Phase 3 clinical studies is
provided as shown below:

[***]

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 4.2(f)

TESARO INDs

 

1.IND 100,996 (Ovarian)

2.IND 117,580 (Breast)

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 4.2(h)

Example of Third Party Development Report

 

See attached. 

 

 

Confidential

 

 

 

[***] 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.

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

 

 

[***]

 

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 5.5(a)

Regulatory Documentation Relating to Initial Compound and Initial Product

 

 

A.Major Niraparib Interactions with FDA:[***]

 

B.Major Niraparib Interactions with EMA:[ ***]

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 7.1(a)

Company Supply Requirements and Timeline

 

This Exhibit 7.1(a) will be revised upon execution of the Clinical Supply
Agreement.

 

7.1(a)(iii) Clinical Supplies

 

The following reflects Company’s projected requirements for clinical supply of
Single Agent Products for the Clinical Trials listed below:[***]

 

*For Trial execution about [***] of total supply is required at least [***]
before [***].  A [***] resupply is required for each of the clinical trials to
be provided [***] (a detailed schedule will be included in the Clinical Supply
Agreement)

 

7.3(c)API Supply for Fixed Dose Formulation Development

 

The following reflects Company’s projected requirements of Compound API for the
periods listed below:

 

[***]

 

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 8.2(d)

Merck Milestone Payments

 

 

 

Merck Milestone Payments*

Merck Milestone

Merck Milestone Payment Amount

On a Licensed Product-by-Licensed Product basis

1st Indication for a given Licensed Product

1. Initiation** of the first Phase III Clinical Trial for a Licensed Product

$[***]

2. Filing and acceptance of the first NDA for a Licensed Product in the United
States

$[***]

3. Filing of the first application for marketing authorization of a Licensed
Product in the EU

$[***]

4. Granting of Marketing Authorization for a

Licensed Product in the U.S.

$[***]

5. Granting of Marketing Authorization *** for a Licensed Product in the EU

$[***]

* All capitalized terms used in this Exhibit 8.2(d) shall have the meaning set
forth in Article I of the Merck License Agreement.

** “Initiation” means first dosing of the first properly enrolled patient in the
relevant Clinical Trial.

*** This milestone requires granting of Marketing Authorization for a Licensed
Product for the relevant indication in any three (3) of the Major European
Countries.

 

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 8.3

Alliance Payments

 

1. Definitions.

 

“Commercialization Expenses” means [***].

“Distribution Expenses” means [***].

“First Prostate Use” of a Prostate-Approved Single Agent Product in a country in
the Company Territory means the first to occur of the event described in the
definition of “Prostate-Approved Single Agent Product” with respect to such
Prostate-Approved Single Agent Product in such country.

 

2.Selection of Reporting Services for Net Sales Allocation

 

2.1  Major Market Net Sales Allocation Methodology.  No later than [***] prior
to the anticipated First Prostate Use of a Prostate-Approved Single Agent
Product in any Major Market, the JCC, based on a recommendation by the JFC, will
develop and approve a methodology that will be used to allocate sales of
Prostate-Approved Single Agent Products by indication in each of the Major
Markets (the “Major Market Net Sales Allocation Methodology”). The Major Market
Net Sales Allocation Methodology will also be used to allocate sales of
Prostate-Approved Single Agent Products by indication in any other countries
deemed appropriate by the JCC (the “Other Included Countries”).  [***]  On an
[***] basis, the JCC will reassess the Major Market Net Sales Allocation
Methodology and its data sources for each of the Major Markets, for prospective
use, and will use reasonable efforts to agree to any required changes in such
methodology.  The JCC will also prospectively reassess the use of such
methodology in the Other Included Countries and whether additional countries
should be included as Other Included Countries.  If two or more distinct
Prostate-Approved Single Agent Products are sold in the same country, the same
Major Market Net Sales Allocation Methodology will be used for all such products
unless otherwise determined by the JCC.  The methodology selected can be in the
form of Net Sales or volume of units.

 

2.2  Residual Allocation Methodologies.  The JCC will also develop and approve
methodologies to be utilized to allocate the sales of Prostate-Approved Single
Agent Products by indication in countries that are not Major Markets or Other
Included Countries on a region-by-region basis (each, a “Residual Allocation
Methodology”) no later than [***] prior to the anticipated First Prostate Use in
each such country.  The Parties expect that Residual Allocation Methodologies
will be used in countries in the following regions: [***].  There will be one
Residual Allocation Methodology per region; provided,  however, that if either
Party reasonably believes that within a region utilization of Prostate-Approved
Single Agent Products in any one country is significantly different from the
other countries in the region such that applying the regional Residual
Allocation Methodology would result in an inappropriate allocation methodology,
the Parties shall discuss in good faith and attempt to agree on whether a
country-specific allocation

Confidential

 

 

 

[***] 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.

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

 

 

methodology should be used in such country for a defined timeframe.  If two or
more distinct Prostate-Approved Single Agent Products are sold in a region, the
same Residual Allocation Methodology will be used for all such products in such
region, unless otherwise determined by the JCC.  The Residual Allocation
Methodologies selected can be in the form of Net Sales or volume of units.

 

2.3  Deadlocks.  If the JCC does not reach unanimous agreement to the Major
Market Net Sales Allocation Methodology, a Residual Allocation Methodology, the
list of Other Included Countries or any other JCC decision described in this
Exhibit 8.3 as provided in Section 2.3(c), such matter will be deemed to be a
Deadlocked Committee Matter as provided in Section 2.3(c).  If a Deadlocked
Committee Matter relating to the Major Market Net Sales Allocation Methodology
or a Residual Allocation Methodology for a country is not resolved prior to
launch of a Prostate-Approved Single Agent Product in such country, [***].   

 

3.Calculation of the Alliance Payments.  For each country in the Company
Territory where a Prostate-Approved Single Agent Product is sold by TESARO (or
any of its Affiliates, licensees (other than Company), sublicensees or Third
Party distributors) during a TESARO Calendar Quarter, TESARO shall calculate the
Alliance Payments within [***] after the end of such TESARO Calendar Quarter as
follows.  For clarity, any reference in this Exhibit 8.3 to “Net Sales” shall
mean Net Sales as defined in this Agreement, without regard to the definition of
Net Sales or a similar term in any agreement between TESARO and a Third Party.

 

3.1  Determination of Prostate Attributable Net Sales

 

For each country that is a Major Market or an Other Included Country, the amount
of Net Sales of such Prostate-Approved Single Agent Product in a TESARO Calendar
Quarter attributable to use in the Company Field shall be calculated as follows,
on a country-by-country basis:

 

(a)        Utilizing the Major Market Net Sales Allocation Methodology, the
Parties will calculate a “Prostate Sales Allocation Factor” for such country for
such TESARO Calendar Quarter.  The Prostate Sales Allocation Factor is a
percentage equal to [***]. The JCC shall determine whether to use Net Sales or
volume of units to calculate the Prostate Sales Allocation Factor for a country,
depending on which data sources will be used in such country.

(b)        The Prostate Sales Allocation Factor will then be multiplied by
[***].

For each country that is neither a Major Market nor an Other Included Country,
the amount of Net Sales of such Prostate-Approved Single Agent Product in a
TESARO Calendar Quarter attributable to use in the Company Field shall be
calculated as follows, on a region-by-region basis:

 

(a)        Utilizing the Residual Allocation Methodology, the Parties will
calculate a “Residual Prostate Sales Allocation Factor” for such region for such
TESARO

Confidential

 

 

 

[***] 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.

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

 

 

Calendar Quarter.  The Residual Prostate Sales Allocation Factor is a percentage
equal to [***].  The JCC shall determine whether to use Net Sales or volume of
units to calculate the Prostate Sales Allocation Factor for a region, depending
on which data sources will be used in such region.

(b)        The Residual Prostate Sales Allocation Factors will then be
multiplied by [***].

3.2  Disproportionate Allocation of Rebates.  Upon the request of either Party,
the JFC shall review and discuss whether rebates payable to federal,
state/provincial, local or other governments, or their agencies, with respect to
sales of a Prostate-Approved Single Agent Product in a country should be
allocated on a disproportionate basis between the Company Field and TESARO Field
when calculating Net Sales of such Prostate-Approved Single Agent Product in
such country to reflect the actual payor mix of such Prostate-Approved Single
Agent Product in such country.  

 

3.3  Adjustments to Prior Period Single Agent Prostate Net Sales

 

It is acknowledged by both Parties that [***].  For this reason, the mechanism
described below allows for an adjustment in a subsequent TESARO Calendar
Quarter.

 

Within [***] after the end of such TESARO Calendar Quarter and upon [***],
TESARO shall determine whether any of the Prostate Sales Allocation Factors and
Residual Prostate Sales Allocation Factors applied to the Net Sales of
Prostate-Approved Single Agent Products under Section 3.1 of this Exhibit 8.3
for a prior TESARO Calendar Quarter needs to be revised.  If a revision is
required, TESARO will recalculate on a region-by-region or country-by-country
basis, as applicable, the Net Sales of Prostate-Approved Single Agent Products
attributable to use in the Company Field under the applicable Major Market Net
Sales Allocation Methodology or Residual Allocation Methodology.  The revised
allocation of Net Sales of Prostate-Approved Single Agent Products for such
TESARO Calendar Quarter will be compared to the initial allocation of such Net
Sales to determine the required adjustment.  After TESARO completes such
recalculations, the JFC shall review and approve any proposed reallocations and
adjustments before they become effective.  [***].  

 

3.4  Total Net Sales of Prostate-Approved Single Agent Products

 

The total TESARO Net Sales of a Prostate-Approved Single Agent Product
attributable to use in the Company Field in any country in the Company Territory
during a given TESARO Calendar Quarter shall be the sum of: (a) the amount of
TESARO Net Sales of such Prostate-Approved Single Agent Product attributable to
use in the Company Field in such country (calculated as described above in
Sections 3.1 of this Exhibit 8.3); and (b) any prior-quarter Net Sales
adjustments with respect to such Single Agent Product that are required due to
updated Prostate Sales Allocation Factors and Residual Prostate Sales Allocation
Factors (as described above in Section 3.3 of this Exhibit 8.3)  (the “TESARO
Prostate-Approved Single Agent Product Net Sales”).  

 

Confidential

 

 

 

[***] 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.

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

 

 

3.5  Determination of Alliance Payments Due to Company

 

TESARO will deduct from the aggregate TESARO Prostate-Approved Single Agent
Product Net Sales in all countries in the Company Territory in a given TESARO
Calendar Quarter (calculated as described above in Section 3.4 of this Exhibit
8.3) the following costs to calculate the Alliance Payment for such TESARO
Calendar Quarter: [***]

 

For clarity, TESARO shall not deduct any milestone payments due to it as part of
this calculation under this Section 3 of this Exhibit 8.3.  

 

If the balance of TESARO Net Sales of Prostate-Approved Single Agent Products
attributable to use in the Company Field in a given TESARO Calendar Quarter less
the deductions detailed above results in a deficit, such balance shall be
reported to Company in the Alliance Payments report and TESARO shall invoice the
Company due with terms consistent with Section 8.14 to the extent Company has
not reimbursed TESARO for such amounts pursuant to another provision of this
Agreement. 

 

4.Alliance Payments Report. TESARO shall deliver a written report (the “Alliance
Payments Report”) to Company setting forth its calculations of the Alliance
Payments, together with reasonable supporting documentation, within [***] after
the end of each TESARO Calendar Quarter. Details to be included in this report
shall be defined by the JFC, and will include a sufficient level of detail to
provide Company with information to assess the Alliance Payments calculation.

 

5.Example Calculation.  An example of the calculations to be performed by TESARO
under Section 3 of this Exhibit 8.3 is included below for illustrative purposes
only:

 

[***]

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 8.4(b)(i)(1)

Pass-through Merck Royalty

 

1.Definitions.  For purposes of this Exhibit 8.4(b)(i)(1), the following terms
shall have the following meanings:

 

“Effective Merck Royalty Rate” means, with respect to a given Prostate-Approved
Single Agent Product and a given TESARO Calendar Quarter, the amount equal to
A/B expressed as a percentage, where:

 

A = the aggregate amount of royalties payable by TESARO to Merck pursuant to the
Merck License Agreement (taking into account all applicable royalty reductions)
with respect to  Combined Worldwide Prostate-Approved Single Agent Product Net
Sales for such Prostate-Approved Single Agent Product during such TESARO
Calendar Quarter; and

 

B = the Combined Worldwide Prostate-Approved Single Agent Product Net Sales for
such Prostate-Approved Single Agent Product during such Calendar Quarter.

 

In the event that TESARO effects a reduction in, or elimination of, the
applicable royalty rate(s) under the Merck License Agreement through a buy down
or other negotiated agreement with Merck, then “A” shall be calculated by
applying the Pass-through Merck Royalty Rates set forth in Section 8.4(b)(i)(1)
and the royalty reductions set forth in this Exhibit 8.4(b)(i)(1) to the
applicable  Combined Worldwide Prostate-Approved Single Agent Product Net Sales.

 

“Merck Compound Patent Rights” means those patents and patent applications that
are listed on Attachment 1 to this Exhibit 8.4(b)(i)(1) and claim the
composition of matter or use of a Compound, together with all (a) substitutions,
divisions, continuations, continuations-in-part, continued prosecution
applications, reissues, renewals, registrations, certificates of invention,
confirmations, re-examinations, extensions, supplementary protection
certificates or the like, or the provisional applications of any such patents
and patent applications and (b) foreign equivalents of any of the above.

 

“Merck First Commercial Sale” means, with respect to a country in the Company
Territory, the first sale of commercial quantities of a Product in such country
to a Third Party on arm’s length terms by a Party, its Affiliate or
(sub)licensee for use in the Field after the receipt of Marketing Approval in
such country. Sales for test marketing, sampling and promotional uses, Clinical
Trial purposes or compassionate or similar use shall not be considered to
constitute a Merck First Commercial Sale.

 

“Merck Royalty Term” means, with respect to a Product and a given country, the
period commencing upon the Merck First Commercial Sale of such Product in such
country and continuing until the later of: (i) the expiration of the last to
expire Merck Valid Claim of a Merck Compound Patent Right covering or claiming
such Product (or the Compounds contained in, or

Confidential

 

 

 

[***] 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.

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

 

 

comprising, such Product); or (ii) the tenth (10th) anniversary of the date of
the Merck First Commercial Sale of such Product in such country (the “Merck
Royalty Term”). 

 

“Merck Valid Claim” means a claim of an issued and unexpired patent included
within the Merck Compound Patent Rights, that has not been revoked or held
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within the time allowed
for appeal, and that has not been disclaimed, denied or admitted to be invalid
or unenforceable through reissue or disclaimer.

 

2.Pass-through Merck Royalty Term.  The Pass-through Merck Royalty under Section
8.4(b)(i)(1) with respect to Prostate-Approved Single Agent Product Net Sales or
Company Combination Product Net Sales, as applicable, shall be payable on a
Product-by-Product and country-by-country basis for so long as royalties are
payable by TESARO to Merck under the Merck License Agreement with respect to the
applicable Prostate-Approved Single Agent Product or Combination Product in such
country; provided,  however, that if TESARO effects a reduction in, or
elimination of, the applicable royalty rate(s) under the Merck License Agreement
through a buy down or other negotiated agreement with Merck, then the
Pass-through Merck Royalty shall be payable until the expiration of the Merck
Royalty Term with respect to the applicable Prostate-Approved Single Agent
Product or Combination Product in such country. 

 

3.Pass-through Merck Royalty Adjustments.  Notwithstanding Section 8.4(b)(i)(1),
in the event that the sale of a Product in a country in the Company Territory
during the applicable royalty term pursuant to Section 2 of this Exhibit
8.4(b)(i)(1) with respect to such Product and such country, would not infringe a
Merck Valid Claim, then Pass-through Merck Royalty Rates set forth in Section
8.4(b)(i)(1) shall be reduced by [***] with respect to Prostate-Approved Single
Agent Product Net Sales or Combination Product Net Sales, as applicable, of such
Product in such country. If a Product is covered by Merck Valid Claims of more
than one Merck Compound Patent Right, the Pass-through Merck Royalty under
Section 8.4(b)(i)(1) shall be payable only once.

 

4.[***].

 

5.Calculation of Royalty Tier for Pass-through Merck Royalty.  In the event that
there are both Company Prostate-Approved Single Agent Product Net Sales and
TESARO Prostate-Approved Single Agent Product Net Sales with respect to a
Prostate-Approved Single Agent Product during a TESARO Calendar Quarter, then
TESARO shall use the report delivered by Company pursuant to Section 8.3(b)(ii)
to determine the Combined Worldwide Prostate-Approved Single Agent Product Net
Sales during such TESARO Calendar Quarter and the Pass-through Merck Royalty
Rate(s) applicable to such Combined Worldwide Prostate-Approved Single Agent
Product Net Sales during such TESARO Calendar Quarter.  In the event that two
(2) or more Pass-through Merck Royalty Rate(s) apply with respect to such
Combined Worldwide Prostate-Approved Single Agent Product Net Sales during such
TESARO Calendar Quarter, TESARO shall calculate the Effective Merck Royalty Rate
with respect to such Combined Worldwide Prostate-Approved Single Agent Product
Net Sales.  TESARO shall

Confidential

 

 

 

[***] 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.

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

 

 

notify Company of the applicable Pass-through Merck Royalty Rate or Effective
Merck Royalty Rate with respect to such Calendar Quarter within [***] after
receipt of the report delivered by Company pursuant to Section
8.3(b)(ii).  Company shall use such Pass-through Merck Royalty Rate or Effective
Merck Royalty Rate to calculate the Pass-through Merck Royalty amounts payable
by Company to TESARO with respect to the Company Prostate-Approved Single Agent
Product Net Sales during such Calendar Quarter, and TESARO shall use such
Pass-through Merck Royalty Rate or Effective Merck Royalty Rate to calculate the
Pass-through Merck Royalty amounts to be deducted when calculating the Alliance
Payments due to Company with respect to TESARO Prostate-Approved Single Agent
Product Net Sales.

 

Confidential

 

 

 

[***] 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.

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

 

 

Attachment 1 to Exhibit 8.4(b)(i)(1)

Merck Compound Patent Rights

 

Patent schedule for MK-4827 and MK-2512

 

(1) IRT-ONC-0121Y: Amide substituted indazole and benzotriazole derivatives as
poly(ADP-ribose)polymerase(PARP) inhibitors

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2007232297

02 April 2007

Granted

2007232297

03 January 2013

Canada

2647545

02 April 2007

Granted

2647545

23 February 2016

China P.R.

200780012001.6

02 April 2007

Granted

101415686

13 March 2013

European Patent Convention

07733600.6

02 April 2007

Allowed

 

 

India

8150/DELNP/08

02 April 2007

Pending

 

 

Japan

2009-503667

02 April 2007

Granted

4611441

22 October 2010

United States

13/091427

21 April 2011

Abandoned

 

 

 

(2) IRT-ONC-0121Y2:  Amide substituted indazoles as
poly(ADP-ribose)polymerase(PARP) inhibitors

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Albania

AL/P/2011/3701

08 January 2008

Granted

3755

23 March 2011

Algeria

090395

08 January 2008

Granted

6603

30 May 2011

Argentina

P080100061

08 January 2008

Granted

AR064777B1

23 April 2014

Armenia

200970674

08 January 2008

Granted

016079

30 January 2012

Australia

2008204380

08 January 2008

Granted

2008204380

28 November 2013

Austria

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Austria

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Azerbaijan

200970674

08 January 2008

Granted

016079

30 January 2012

Barbados

2001/1480

08 January 2008

Pending

 

 

Belarus

200970674

08 January 2008

Granted

016079

30 January 2012

Belgium

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Belgium

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Belize

587.09

08 January 2008

Granted

587.09

05 March 2010

Bermuda

418EP

08 January 2008

Granted

418P

26 September 2012

Bosnia-Herzegovina

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Brazil

PI0806245-5

08 January 2008

Pending

 

 

Bulgaria

08702101.0

08 January 2008

Granted

2109608

23 March 2011

 

Confidential

 

 

 

[***] 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.

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

 

 

 

 

 

 

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Canada

2674436

08 January 2008

Granted

2674436

17 July 2012

Chile

00046-2008

08 January 2008

Pending

48.598

03 May 2013

China P.R.

200880001926.5

08 January 2008

Granted

101578279

17 July 2013

Colombia

09068415

08 January 2008

Granted

2532

24 August 2012

Costa Rica

10910

08 January 2008

Granted

3180

23 March 2015

Croatia

08702101.0

08 January 2008

Granted

P20110447

23 March 2011

Cyprus

CY20111100595

08 January 2008

Granted

CY1111584

23 March 2011

Czech Republic

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Czech Republic

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Denmark

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Denmark

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Dominican Republic

P2009-0170

08 January 2008

Pending

 

 

Ecuador

SP-09-9484

08 January 2008

Pending

 

 

Egypt

PCT1065/2009

08 January 2008

Pending

 

 

El Salvador

2009003321

08 January 2008

Granted

20090008141

14 February 2011

Estonia

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Eurasian Patent Convention

200970674

08 January 2008

Granted

016079

30 January 2012

European Patent Convention

08702101.0

08 January 2008

Granted

2109608

23 March 2011

European Patent Convention

11157369.7

08 March 2011

Granted

2336120

16 July 2014

European Patent Convention

14176452.2

26 November 2014

Pending

 

 

Finland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Finland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

France

08702101.0

08 January 2008

Granted

2109608

23 March 2011

France

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Georgia

AP2008011413

08 January 2008

Granted

P5337

25 November 2011

Germany

08702101.0

08 January 2008

Granted

602008005711.9

23 March 2011

Germany

11157369.7

08 March 2011

Granted

602008033393.0

16 July 2014

Great Britain

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Great Britain

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Greece

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Greece

11157369.7

08 March 2011

Granted

2336120

16 July 2014

 

Confidential

 

 

 

[***] 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.

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

 

 

 

 

 

 

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Guatemala

A-2009-00190

08 January 2008

Granted

5761

05 May 2014

Gulf Cooperation Council

2008/9897

05 January 2008

Pending

 

 

Honduras

2009-001260

08 January 2008

Granted

5355

08 March 2013

Hong Kong

09110676.1

08 January 2008

Granted

1131137

09 December 2011

Hong Kong

11108534.3

08 January 2008

Granted

1154386

06 February 2015

Hungary

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Iceland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

India

4674/DELNP/2009

08 January 2008

Granted

IN270342

14 December 2015

Indonesia

W00200901818

08 January 2008

Granted

IDP0030184

10 February 2012

Ireland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Ireland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Israel

199264

08 January 2008

Granted

199264

28 September 2013

Italy

502011901952934

08 January 2008

Granted

2109608

23 March 2011

Italy

502014000000867

08 March 2011

Granted

2336120

16 July 2014

Japan

2009-545240

08 January 2008

Granted

4611444

22 October 2010

Kazakhstan

200970674

08 January 2008

Granted

016079

30 January 2012

Korea South

10-2009-7014520

08 January 2008

Pending

 

 

Kyrgyzstan

200970674

08 January 2008

Granted

016079

30 January 2012

Latvia

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Lebanon

8156

08 January 2008

Granted

8156

22 September 2008

Lithuania

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Luxembourg

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Macao

J/001224

08 January 2008

Granted

J/00124

11 December 2013

Macedonia

P-2011/142

08 January 2008

Granted

2109608

23 March 2011

Malaysia

PI 20092876

08 January 2008

Granted

147789

31 January 2013

Malta

EP00300

08 January 2008

Granted

2109608

23 March 2011

Mexico

MX/a/2009/007200

08 January 2008

Granted

277664

29 July 2010

Moldova

200970674

08 January 2008

Granted

016079

30 January 2012

Mongolia

4314

08 January 2008

Granted

3334

25 October 2009

Morocco

PV32111

08 January 2008

Granted

31554

02 August 2010

Netherlands

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Netherlands

11157369.7

08 March 2011

Granted

2336120

16 July 2014

New Zealand

578256

08 January 2008

Granted

578256

02 April 2012

Nicaragua

2009-0135

08 January 2008

Pending

 

 

Norway

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Norway

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Pakistan

20/2008

08 January 2008

Pending

 

 

Peru

97

08 January 2008

Granted

6371

29 February 2012

 

Confidential

 

 

 

[***] 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.

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

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Philippines

1-2009-501286

08 January 2008

Granted

1-2009-501286

21 September 2012

Poland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Poland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Portugal

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Portugal

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Romania

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Russian Federation

200970674

08 January 2008

Granted

016079

30 January 2012

Serbia

P-236/2011

08 January 2008

Granted

51780

23 March 2011

Singapore

200904280-5

08 January 2008

Granted

153520

13 July 2012

Slovak Republic

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Slovak Republic

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Slovenia

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Solvenia

11157369.7

08 March 2011

Granted

2336120

16 July 2014

South Africa

2009/03898

08 January 2008

Granted

2009/03898

28 April 2010

Spain

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Spain

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Sweden

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Sweden

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Switzerland

08702101.0

08 January 2008

Granted

2109608

23 March 2011

Switzerland

11157369.7

08 March 2011

Granted

2336120

16 July 2014

Taiwan

097100730

08 January 2008

Pending

 

 

Tajikistan

200970674

08 January 2008

Granted

016079

30 January 2012

Thailand

0801000088

08 January 2008

Pending

 

 

Trinidad

TT/A/2009/00132

08 January 2008

Pending

 

 

Tunisia

TN2009/0286

08 January 2008

Granted

21034

20 September 2011

Turkey

2011/05543

08 January 2008

Granted

2011 05543

23 March 2011

Turkmenistan

200970674

08 January 2008

Granted

016079

30 January 2012

Ukraine

2009 08335

08 January 2008

Granted

97658

12 March 2012

United States

12/006993

08 January 2008

Granted

8071623

06 December 2011

Venezuela

2008-000029

08 January 2008

Pending

 

 

Vietnam

1-2009-01655

08 January 2008

Pending

 

 

 

Confidential

 

 

 

[***] 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.

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

 

 

(3) TER-ONC-1729: Pharmaceutically acceptable salts of
2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide

 

 

 

 

 

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2009203598

08 January 2009

Granted

2009203598

09 January 2014

Brazil

PI0906020-0

08 January 2009

Pending

 

 

Canada

2711491

08 January 2009

Pending

2653529

09 February 2016

China P.R.

200980101861.6

08 January 2009

Pending

 

 

European Patent Convention

09700579.7

08 January 2009

Granted

2240466

29 July 2015

France

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Germany

09700579.7

08 January 2009

Granted

602009032466.7

29 July 2015

Great Britain

09700579.7

08 January 2009

Granted

2240466

29 July 2015

India

4920/DELNP/2010

08 January 2009

Pending

 

 

Ireland

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Israel

206201

08 January 2009

Granted

206201

01 November 2011

Italy

502015000061194

08 January 2009

Granted

2240466

29 July 2015

Japan

2010-541101

08 January 2009

Pending

 

 

Korea South

10-2010-7015011

08 January 2009

Pending

 

 

Mexico

MX/a/2010/006593

08 January 2009

Pending

 

 

Netherlands

09700579.7

08 January 2009

Granted

2240466

29 July 2015

New Zealand

586675

08 January 2009

Granted

586675

06 August 2012

Russian Federation

2010133241

08 January 2009

Granted

2495035

10 October 2013

South Africa

2010/03902

08 January 2009

Granted

2010/03902

23 February 2011

Spain

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Switzerland

09700579.7

08 January 2009

Granted

2240466

29 July 2015

Turkey

2015/13219

08 January 2009

Granted

2015 13219

29 July 2015

United States

12/811922

08 January 2009

Granted

8436185

07 May 2013

 

(4) IRT-ONC-0129: Pyridinone and pyridazinone derivatives as inhibitors of
poly(ADP-ribose)polymerase (PARP)

 

 

 

 

 

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2007266836

25 May 2007

Granted

2007266836

09 January 2014

Brazil

PI0711741-8

25 May 2007

Pending

 

 

Canada

2653529

25 May 2007

Pending

 

 

China P.R.

200780020136.7

25 May 2007

Pending

 

 

China P.R.

201310316726.1

25 July 2013

Pending

 

 

European Patent Convention

07733716.0

25 May 2007

Pending

 

 

India

9794/DELNP/2008

25 May 2007

Pending

 

 

Confidential

 

 

 

[***] 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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Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Israel

195113

25 May 2007

Granted

195113

29 August 2014

Japan

2009-512681

25 May 2007

Granted

5351755

30 August 2013

Korea South

10-2008-7029132

25 May 2007

Granted

10-1529891

12 June 2015

Mexico

MX/a/2008/015014

25 May 2007

Granted

311801

29 July 2013

New Zealand

572815

25 May 2007

Granted

572815

05 March 2012

Norway

2008 5397

25 May 2007

Pending

 

 

Russian Federation

2008152824

25 May 2007

Granted

2472782

20 January 2013

South Africa

2008/09238

25 May 2007

Granted

2008/09238

30 December 2009

United States

12/227513

25 May 2007

Granted

8188084

29 May 2012

 

(5) IRT-ONC-0152: Pyridazinone derivatives as PARP inhibitors

 

 

 

 

 

 

 

Country

App. No.

Filing Date

Status

Pat. No.

Grant Date

Australia

2008322676

14 November 2008

Granted

2008322676

20 March 2014

Brazil

PI0820236-2

14 November 2008

Pending

 

 

Canada

2704714

14 November 2008

Pending

 

 

China P.R.

200880115590.5

14 November 2008

Granted

101855221

30 October 2013

European Patent Convention

08850429.5

14 November 2008

Granted

2220073

03 September 2014

France

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Great Britain

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Germany

08850429.5

14 November 2008

Granted

602008034267.0

03 September 2014

India

2638/CHENP/2010

14 November 2008

Pending

 

 

Israel

205142

14 November 2008

Granted

205142

31 December 2014

Italy

502014000002462

14 November 2008

Granted

2220073

03 September 2014

Japan

2010-533666

14 November 2008

Granted

5758630

12 June 2015

Korea South

10-2010-7013113

14 November 2008

Pending

 

 

Mexico

MX/a/2010/005070

14 November 2008

Granted

298063

12 April 2012

Netherlands

08850429.5

14 November 2008

Granted

2220073

03 September 2014

New Zealand

585395

14 November 2008

Granted

585395

09 July 2012

Russian Federation

2010123874

14 November 2008

Granted

2490265

20 August 2013

South Africa

2010/02466

14 November 2008

Granted

2010/02466

29 December 2010

Switzerland

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Spain

08850429.5

14 November 2008

Granted

2220073

03 September 2014

Turkey

201414390

14 November 2008

Granted

2014 14390

03 September 2014

United States

12/739262

14 November 2008

Granted

8268827

18 September 2012

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 8.4(b)(i)(2)

Pass-through AstraZeneca Royalties

 

[***]

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 8.4(b)

Summary of Economic Transfers between the Parties

 

[***]

 

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 10.2(j)

TESARO Disclosure of Certain Development Activities

 

[***]

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 10.4

Merck License Agreement Provisions

 

2.04Sublicense Agreements.  . . . Licensee shall (i) use reasonable efforts to
procure the performance by any sublicensee of the terms of each such sublicense
Agreement, and (ii) ensure that any sublicensee will comply with the applicable
terms and conditions of this Agreement.  The grant of any such sublicense will
not relieve Licensee of its obligations under this Agreement, except to the
extent such obligations are satisfactorily performed by such Affiliate or
sublicensee.  Licensee shall be liable for the performance or non-performance of
its Affiliates and sublicensees hereunder.

 

9.04No Publicity.  A Party may not use the name of the other Party in any
publicity or advertising and may not issue a press release or otherwise
publicize or disclose any information related to the existence of this Agreement
or the terms or conditions herein, except (a) on the advice of its counsel as
required by law (e.g., any Securities and Exchange Commission filings and
disclosures) and provided the Party who will be disclosing such information has
consulted with the other Party to the extent feasible prior to such disclosure
with respect to the substance of the disclosure; or (b) as consented to in
advance by the other Party in writing.  The Parties shall agree on a form of
initial press release that may be used by either Party on an ongoing basis to
describe this Agreement.  Licensee shall provide Merck with reasonable advance
written notice of any press release or other public disclosure of the results of
any of its work on Licensed Product under this Agreement. 

 

9.05Terms of Agreement.  Neither Party nor its Affiliates shall disclose any
terms or conditions of this Agreement to any Third Party without the prior
consent of the other Party, except as follows: A Party and its Affiliates may
disclose the terms or conditions of this Agreement (but not any other
Proprietary Information, which may be disclosed only as described elsewhere in
this Article IX), (a) on a need-to-know basis to its legal and financial
advisors to the extent such disclosure is reasonably necessary, provided that
such advisors are subject to confidentiality with regard to such information
under an agreement or ethical obligation; (b) to a Third Party in connection
with (i) a financing (or proposed financing) or an equity investment (or
proposed investment) in such Party or its Affiliates, including to its
shareholders and prospective shareholders, (ii) a merger, consolidation or
similar transaction by such Party or its Affiliates, (iii) the sale of all or
substantially all of the assets of such Party or its Affiliates, or (iv) in
connection with a sale of the royalties or other rights of payments contained
herein, provided that such Third Party executes a non-use and non-disclosure
agreement that provides for substantially the same protection of such
information as such disclosing Party owes under this Agreement with respect to
Proprietary Information of the other Party; (c) to the United States Securities
and Exchange Commission or any other securities exchange or governmental entity,
including as required to make an initial or subsequent public offering, or (d)
as otherwise required by law or regulation, provided that in the case of (c) and
(d) the disclosing Party shall (x) if practicable, provide the other Party with
reasonable advance notice of and an opportunity to comment on any such required
disclosure, (y) if requested by such other Party, seek, or cooperate with such
Party’s efforts to obtain, confidential treatment or a protective order with
respect to any such

Confidential

 

 

 

[***] 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.

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

 

 

disclosure to the extent available at such other Party’s expense, and (z) use
good faith efforts to incorporate the comments of such other Party in any such
disclosure or request for confidential treatment or protective order. 

 

Confidential

 

 

 

[***] 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.

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

 

 

Exhibit 10.5

Compliance with Laws

1.1.Each Party acknowledges that the other Party aims to perform its activities,
and to have other parties (such as the other Party hereunder) with which it
enters into business arrangements to perform their activities under such
arrangements, in accordance with the highest ethical standards and best industry
practices, including any voluntary codes of practice applicable in the
industry.  The Parties agree to use reasonable efforts to help ensure that the
Parties do not fail to meet such aim with respect to activities hereunder
through any violation of the U.S. Foreign Corrupt Practices Act (the “FCPA”),
the U.S. False Claims Act (the “FCA”), the U.S. Anti-Kickback Law (the “AKA”),
the United Kingdom Bribery Act (the “UKBA”), or any laws or regulations
regarding governmental research grants (e.g., rules governing grants from the
National Institutes of Health, or other governmental agencies.)

1.2.Each Party shall comply with all laws and regulations concerning its efforts
in any country or jurisdiction where it is providing work hereunder or otherwise
applying to any of its activities under this Agreement.  Each Party shall use
reasonable efforts to ensure that its personnel performing hereunder become
reasonably familiar with the FCPA, the FCA, the UKBA and the AKA, and their
prohibitions and purposes, and that they will not undertake any actions that
would violate the FCPA, the FCA, the UKBA and the AKA.  Accordingly, each Party
hereby warrants that:

(i)neither it nor its agents or employees whose duties pertain to this Agreement
are excluded from a federal health care program as outlined in Sections 1128 and
1156 of the Social Security Act (see the Office of Inspector General of the
Department of Health and Human Services List of Excluded Individuals / Entities
at http://oig.hhs.gov/exclusions/exclusions_list.asp);

(ii)neither it nor its agents or employees whose duties pertain to this
Agreement are debarred by the FDA under 21 U.S.C. 335a (see the FDA Office of
Regulatory Affairs Debarment List at
http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm);

(iii)neither it, nor its agents or employees are otherwise excluded from
contracting with the federal government (see the System for Award Management at
https://www.sam.gov/portal/SAM/#1);

(iv)it, or its agents or employees, if required, are duly licensed and in good
standing in accordance with applicable U.S., state or other applicable
governmental licensing requirements;

(v)no payment or offer to pay, or the giving or offering to give, anything of
value to an official or employee of any government or any department, agency or

Confidential

 

 

 

[***] 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.

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

 

 

instrumentality thereof (including any health or medical providers owned or
controlled by the government), or to any political party or any candidate for
political office, shall be made with the purpose of influencing any decisions
favorable to either Party or its Affiliates and the business resulting therefrom
in contravention of the FCPA or the laws of the country in which it is providing
work;

(vi)it has not paid, nor offered or agreed to pay, nor caused to be paid,
directly or indirectly, any political contributions, fees or commissions to any
governmental employee or representative (including any employee of any health or
medical provider owned or controlled by the government) that would appear to
cause a violation of the FCPA;

(vii)it will not directly or indirectly offer, pay, promise to pay, or authorize
the giving of money or anything of value to any governmental official or
representative, to any political party or official thereof, or to any candidate
for political office, or to any other person, for the purpose of:

a.inappropriately influencing any act or decisions of such person, official,
political party, party official, or candidate in, if applicable, its official
capacity, including a decision to fail to perform official functions; or

b.inducing such person, official, political party, party official, or candidate
to use influence with the government, any instrumentality thereof, or any other
entity to affect or influence any act or decision of such government or
instrumentality, or entity, in order to assist TESARO or Company in obtaining or
retaining business for or with, or directing business to, any Affiliate or Third
Party.

Each Party further agrees that if subsequent developments cause the
certifications and information reported herein to be no longer accurate or
complete, it will immediately so advise the other Party in writing.

1.3In the event of a claim or investigation, or an official request for a Party
to cooperate with respect to any such claim or investigation, by a Regulatory
Authority or other legal authority having jurisdiction over either Party, of an
alleged violation of the FCPA arising from any activities conducted by the other
Party relating specifically to this Agreement or to the Products, the other
Party shall reasonably provide such Regulatory Authority or other legal
authority having jurisdiction over the Party with access to the other Party’s
facilities, records (financial and otherwise), and supporting documentation, as
reasonably requested by the Party or its agents in order to cooperate in
connection with such claim or investigation.  Each Party acknowledges that the
provisions of this Exhibit 10.5 granting the other Party certain audit rights
shall in no way relieve the Party of any of its obligations under the Agreement,
nor shall such provisions require the other Party to conduct any such audits.

Confidential

 

 

 

[***] 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.

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

 

 

1.4During the Term, each Party shall maintain true, accurate and complete books
and records, including those:  (i) documenting its interactions with any
government or its officials or employees relating to its activities in
connection with any Product; (ii) payments made to any officials or employees of
any government or any department, agency or instrumentality thereof; and (iii)
political contributions.  Each Party shall also maintain a reasonable system of
internal accounting controls sufficient to satisfy the FCPA.

1.5 Each Party acknowledges and agrees that any breach of its obligations under
this Exhibit 10.5 shall be a basis for notification of a material breach of this
Agreement.

1.6Notwithstanding anything to the contrary in this Agreement, a Party may
disclose its terms and conditions (including any financial terms) to any
governmental authorities in the U.S. or those in a country where it performs
activities in connection with any Product that such Party determines in good
faith has a legitimate need for access to such information for purposes of
investigating or determining either Party’s compliance with Applicable Law.

1.7The Parties acknowledge that certain laws, now or in the future, may require
pharmaceutical, medical device and other companies to disclose information on
compensation, gifts or other remuneration provided to physicians, institutions,
and other health care professionals.  Either Party may report information about
remuneration provided under this Agreement.  Once reported, such information may
be publicly accessible.

 

Confidential

 

 

 

[***] 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.

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