Exhibit 10.1

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

FINAL VERSION

AMENDED AND RESTATED

COLLABORATION AGREEMENT

BY AND BETWEEN

OREXIGEN THERAPEUTICS, INC.

AND

TAKEDA PHARMACEUTICAL COMPANY LIMITED

DATED

July 31, 2015

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

FINAL VERSION

TABLE OF CONTENTS

 

              Page  

1.

 

DEFINITIONS

     2   

2.

 

DEVELOPMENT

     17     

2.1

  

Overview.

     17     

2.2

  

Development.

     18   

3.

 

COMMERCIALIZATION; CO-PROMOTION

     25     

3.1

  

Commercialization Activities.

     25     

3.2

  

Additional Diligence Obligations.

     25     

3.3

  

Commercialization.

     27     

3.4

  

Regulatory Responsibilities.

     29     

3.5

  

Orexigen’s Co-Promote Activities.

     31     

3.6

  

Pharmacovigilance.

     33     

3.7

  

Recalls and Product Safety.

     34     

3.8

  

Trademarks.

     34   

4.

 

PRODUCT SUPPLY

     36     

4.1

  

Manufacturing Services Agreement; Quality Agreement.

     36     

4.2

  

Takeda’s Option to Manufacture.

     36     

4.3

  

[Intentionally Omitted.]

     36     

4.4

  

Commercial Packaging.

     36   

5.

 

GOVERNANCE

     37     

5.1

  

Joint Steering Committee.

     37     

5.2

  

Joint Development Committee.

     38     

5.3

  

Joint Commercialization Committee.

     40     

5.4

  

Joint Manufacturing Committee.

     40     

5.5

  

Additional Committees.

     41     

5.6

  

General Committee Procedures.

     41     

5.7

  

Committee Decision-Making.

     42     

5.8

  

Orexigen’s Membership in Committees.

     43     

5.9

  

Alliance Managers.

     44   

6.

 

LICENSES

     44     

6.1

  

Licenses to Takeda for Products.

     44     

6.2

  

Sublicensing.

     45     

6.3

  

Licenses to Orexigen.

     45     

6.4

  

Patent Marking.

     46     

6.5

  

No Implied Licenses; Upstream Agreements.

     46     

6.6

  

Parallel Trade.

     46   

 

- 1 -

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

FINAL VERSION

 

7.

 

FINANCIAL TERMS

     46     

7.1

  

Upfront Payment.

     46     

7.2

  

Milestone Payments.

     46     

7.3

  

Royalty Payments.

     49     

7.4

  

Royalty Payment Reports.

     51     

7.5

  

Manner of Payment.

     51     

7.6

  

Records Retention.

     52     

7.7

  

Audits.

     52     

7.8

  

Currency Exchange.

     52     

7.9

  

Taxes.

     52     

7.10

  

Interest Due.

     53   

8.

 

REPRESENTATIONS, WARRANTIES, AND COVENANTS; DISCLAIMERS; LIMITATION OF LIABILITY

     53     

8.1

  

Mutual Representations and Warranties.

     53     

8.2

  

Additional Representations and Warranties of Orexigen.

     54     

8.3

  

Additional Representations and Warranties of Takeda.

     57     

8.4

  

Mutual Covenants.

     57     

8.5

  

Additional Covenants of Orexigen.

     58     

8.6

  

Additional Covenants of Takeda.

     59     

8.7

  

DISCLAIMERS.

     61     

8.8

  

LIMITATION OF LIABILITY.

     62     

8.9

  

Knowledge Standard.

     62   

9.

 

INTELLECTUAL PROPERTY

     62     

9.1

  

Ownership of Inventions.

     62     

9.2

  

Prosecution of Collaboration Patents.

     63     

9.3

  

Enforcement of Collaboration Patents or Product Trademarks Against Infringers.

     65     

9.4

  

Patent Term Extension.

     68     

9.5

  

Regulatory Patent Listing.

     68     

9.6

  

Defense Against Claims of Infringement of Third Party Patents.

     68     

9.7

  

Third Party Licenses.

     69   

10.

 

CONFIDENTIALITY

     69     

10.1

  

Nondisclosure.

     69     

10.2

  

Exceptions.

     70     

10.3

  

Authorized Disclosure.

     70     

10.4

  

Terms of this Agreement.

     71     

10.5

  

Securities Filings.

     71     

10.6

  

Relationship to Confidentiality Agreement.

     72     

10.7

  

Publications.

     72   

 

- 2 -

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

FINAL VERSION

 

 

10.8

  

Publicity.

     73     

10.9

  

Third Party Information.

     73   

11.

 

INDEMNITY AND INSURANCE

     73     

11.1

  

Takeda Indemnity.

     73     

11.2

  

Orexigen Indemnity.

     74     

11.3

  

Indemnification Procedure.

     74     

11.4

  

Dante Indemnity.

     75     

11.5

  

Insurance.

     75   

12.

 

TERM AND TERMINATION

     75     

12.1

  

Term; Expiration.

     75     

12.2

  

Termination for Cause.

     75     

12.3

  

Termination for Safety Reasons.

     76     

12.4

  

Termination for Insolvency.

     77     

12.5

  

Termination for Patent Challenge.

     77     

12.6

  

Unilateral Termination by Takeda.

     77     

12.7

  

Consequences of Termination.

     77     

12.8

  

Consequences of Expiration.

     80     

12.9

  

Survival.

     81     

12.10

  

No Limitation on Remedies.

     81   

13.

 

DISPUTE RESOLUTION

     81     

13.1

  

Exclusive Dispute Resolution Mechanism.

     81     

13.2

  

Resolution by Executive Officers.

     81     

13.3

  

Alternative Dispute Resolution.

     81     

13.4

  

Survivability.

     82     

13.5

  

Preliminary Injunctions.

     82     

13.6

  

Patent Disputes.

     82     

13.7

  

Confidentiality.

     82   

14.

 

MISCELLANEOUS

     82     

14.1

  

HSR.

     82     

14.2

  

Severability.

     82     

14.3

  

Notices.

     83     

14.4

  

Force Majeure.

     84     

14.5

  

Assignment.

     84     

14.6

  

Further Assurances.

     85     

14.7

  

Waivers, Modifications and Amendments.

     85     

14.8

  

Governing Law.

     86     

14.9

  

Relationship of the Parties.

     86     

14.10

  

Entire Agreement.

     86     

14.11

  

Exports.

     86     

14.12

  

Interpretation.

     86   

 

- 3 -

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

FINAL VERSION

 

 

14.13

  

Performance by Affiliates.

     86     

14.14

  

Counterparts; Electronic Delivery.

     87   

 

- 4 -

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

FINAL VERSION

AMENDED AND RESTATED COLLABORATION AGREEMENT

THIS AMENDED AND RESTATED COLLABORATION AGREEMENT (the “Agreement”) is made and
entered into as of July 31, 2015 (the “Amended and Restated Effective Date”), by
and between Orexigen Therapeutics, Inc., a Delaware corporation located at 3344
N. Torrey Pines Court, Suite 200, La Jolla, California 92037, United States of
America (“Orexigen”), and Takeda Pharmaceutical Company Limited, a Japanese
corporation with a principal place of business at 1-1, Doshomachi 4-Chome
Chuo-ku, Osaka 540-8645, Japan (“Takeda”). Orexigen and Takeda are sometimes
referred to herein individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Orexigen has certain expertise and experience of interest to Takeda
relating to certain pharmaceutical therapeutic molecules;

WHEREAS, Takeda has expertise and experience in, and resources and funding for,
the development, manufacture and commercialization of pharmaceutical therapeutic
molecules;

WHEREAS, Orexigen has rights under certain patent, know-how and trademark rights
relating to such pharmaceutical therapeutic molecules, including Orexigen’s
therapeutic product, Contrave® (as defined below), and Orexigen has invested
substantial resources and funding in developing Contrave;

WHEREAS, Takeda and Orexigen desire to collaborate to continue the conduct of
development and commercialization activities for Contrave, including the
investment of resources and funding by Takeda for reimbursement of past research
and development expenditures made by Orexigen and to support the future
development and commercialization of Contrave;

WHEREAS, Orexigen desires to have the option to Co-Promote (as defined below)
Contrave in the Territory, and Takeda is willing to grant such option as set
forth herein;

WHEREAS, the Parties entered into that certain Collaboration Agreement dated as
of September 1, 2010 (the “Original Effective Date”), as amended by that certain
Amendment Number 1 to the Collaboration Agreement dated September 26, 2013 (the
“Amendment No. 1 Effective Date”) between the Parties (collectively, the
“Original Collaboration Agreement”); and

WHEREAS, the Parties have agreed to amend the Original Collaboration Agreement
as set forth herein, and, effective as of the Amended and Restated Effective
Date, to replace the Original Collaboration Agreement, in its entirety,
including its Exhibits, with this Agreement.

 

- 1 -

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

FINAL VERSION

 

AGREEMENT

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

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

1.1 “Affiliate” of a Person means any other Person that directly or indirectly
is controlled by, controls or is under common control with such Person. For the
purposes of this definition, the term “control” (including, with correlative
meanings, the terms “controlled by” and “under common control with”) as used
with respect to a Person means (a) in the case of a corporate entity, direct or
indirect ownership of voting securities entitled to cast at least fifty percent
(50%) of the votes in the election of directors or (b) in the case of a
non-corporate entity, direct or indirect ownership of at least fifty percent
(50%) of the equity interests with the power to direct the management and
policies of such entity; provided that, if local Laws restrict foreign
ownership, control shall be established by direct or indirect ownership of the
maximum ownership percentage that may, under such local Laws, be owned by
foreign interests.

1.2 “Alliance Manager” has the meaning set forth in Section 5.9.

1.3 “Amended and Restated Effective Date” has the meaning set forth in the first
paragraph of this Agreement.

1.4 “Bankruptcy Code” has the meaning set forth in Section 12.4.

1.5 “Breaching Party” has the meaning set forth in Section 12.2.1.

1.6 “Business Day” means a day other than Saturday, Sunday or any day on which
commercial banks located in the State of New York, U.S., or Japan are authorized
or obligated by Laws to close.

1.7 “Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31;
provided, however, that (a) the first Calendar Quarter of the Term shall extend
from the Original Effective Date to the end of the first complete Calendar
Quarter thereafter; and (b) the last Calendar Quarter of the Term shall end upon
the expiration or termination of this Agreement.

1.8 “Calendar Year” means (a) for the first Calendar Year of the Term, the
period beginning on the Original Effective Date and ending on December 31, 2011,
(b) for each Calendar Year of the Term thereafter, each successive period
beginning on January 1 and ending twelve (12) consecutive calendar months later
on December 31, and (c) for the last Calendar Year of the Term, the period
beginning on January 1 of the Calendar Year in which this Agreement expires or
terminates and ending on the effective date of expiration or termination of this
Agreement.

1.9 “Change of Control” means the occurrence of any of the following:

(a) a Party entering into a merger, consolidation, stock sale or sale or
transfer of all or substantially all of its assets, or other similar transaction
or series of related

 

- 2 -

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

FINAL VERSION

 

transactions with another entity, unless, following such transaction or
transactions, (i) the individuals and entities who were the beneficial owners of
the outstanding voting securities of such Party immediately prior to such
transaction or transactions beneficially own, directly or indirectly, at least
fifty percent (50%) of the combined voting power of the then outstanding voting
securities entitled to vote generally in the election of directors or similar
governing persons of the corporation or other entity resulting from such
transaction or transactions (“Successor”) in substantially the same proportions
as their ownership immediately prior to such transaction or transactions of such
outstanding voting securities, and (ii) at least fifty percent (50%) of the
members of the Board of Directors or similar governing body of the Successor
were members of the Board of Directors of such Party at the time of the
execution of the initial agreement, or the action of the Board of Directors of
such Party, governing such transaction or transactions; or

(b) any transaction or series of related transactions in which any Person or
group of Persons acquires beneficial ownership of securities of a Party
representing more than fifty percent (50%) of the combined voting power of the
then outstanding securities of such Party;

provided, however, that notwithstanding subsection (a) or (b) above, a stock
sale to underwriters of a public offering of such Party’s capital stock shall
not constitute a Change of Control.

1.10 “Clinical Trial(s)” means any human clinical study of a pharmaceutical
product, including Phase IV Trials.

1.11 “Clinical Trial Product Liabilities” means all losses, damages, fees, costs
and other liabilities incurred by a Party or its Affiliates and resulting from
human use of Product in Clinical Trials during the Term but excluding […***…].

1.12 “Collaboration” means the Development and Commercialization activities
conducted by the Parties pursuant to this Agreement.

1.13 “Collaboration Patents” means the Orexigen Patents and the Takeda Patents.

1.14 “Combination Product” means any pharmaceutical composition, branded or
generic, containing the Licensed Compounds in combination with any other
clinically active ingredient(s) that is not a Licensed Compound, whether
packaged together or in the same therapeutic formulation.

1.15 “Commercial Packaging” means all activities after completion of
Manufacturing of Product in finished bulk form related to final packaging and
labeling of Product (in commercial packaging presentation) for commercial use,
including primary packaging and insertion of materials such as patient inserts,
patient medication guides, and

 

- 3 -

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

FINAL VERSION

 

professional inserts and any other written, printed or graphic materials
accompanying Product, considered to be part of the finished packaged Product in
accordance with the applicable specifications and legal requirements, and all
testing and release thereof. “Commercial Packaging” shall include stability
testing to the extent the right and responsibility to perform stability testing
is transferred to Takeda pursuant to Section 4.4.

1.16 “Commercialization” means all activities, whether initiated or conducted
prior to or following receipt of Regulatory Approval for a Product in the Field
and in the Territory, undertaken pursuant to the Commercialization Plan in
support of the promotion, marketing, sale and distribution (including importing,
exporting, transporting, customs clearance, warehousing, invoicing, handling and
delivering Product to customers) of the Product, including: (a) sales force
efforts, detailing, advertising, marketing, sales and distribution (as described
in Section 3.3.5), pricing, managed markets and medical affairs, including
publications, medical education, medical information, clinical science liaison
activities, investigator initiated sponsored research programs and health
economics and outcomes research, (b) the preparation, filing, and maintenance of
Regulatory Filings, including the filing of annual updates, but excluding any
such activities relating to obtaining the first, and only the first, Regulatory
Approval for such Product, and (c) other similar activities directly relating to
the Product in or for the Territory. “Commercialization” shall exclude
Development and Manufacturing activities. When used as a verb, “Commercialize”
means to engage in Commercialization activities.

1.17 “Commercialization Costs” means the […***…] costs and expenses incurred by
a Party after the Original Effective Date in connection with Commercialization
activities, […***…]. Commercialization Costs shall be considered a cost or
expense incurred by a Party after the Original Effective Date, even though the
actual payment for such cost or expense is made prior to the Original Effective
Date, if the corresponding work is performed after the Original Effective Date,
and shall be considered a cost or expense that is not incurred by a Party after
the Original Effective Date if the actual payment for such cost or expense is
made after the Original Effective Date, but the corresponding work was performed
prior to the Original Effective Date. Commercialization Costs shall also include
(a) all […***…] costs incurred by Orexigen and (b) all […***…] costs, including
[…***…] costs, […***…], incurred by Takeda, in each of (a) and (b) to the extent
relating to Manufacture of Product for Commercialization activities.
Commercialization Costs do not include: (i) […***…] costs, other than as
described in subsection (b) above; (ii) certain costs set forth in Exhibit 3.5.3
or in the Co-Promote Agreement, if any; (iii) […***…]; and (iv) […***…].

1.18 “Commercialization Plan” means a plan to be agreed upon by the Parties
pursuant to Section 3.3.1, that details the Commercialization activities to be
conducted with respect to a Product during the Term, which plan shall describe
the strategic Commercialization objectives and activities (including
advertising, education, planning, promotion, sales, including

 

- 4 -

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

FINAL VERSION

 

sales force incentive plans and a PDE frequency call plan by prescription
decile, medical affairs, including a publications plan, and managed markets,
including a pricing and discounting plan) for the Product in the Field in the
Territory, and the corresponding budget and sales forecast for the Product;
provided, further, that following Orexigen’s election to Co-Promote pursuant to
Section 3.5, such plan shall also be updated to include a detailed call target
plan, sales force incentive plans, and any other activities to be conducted by
Orexigen with respect to the Commercialization of Contrave in the Territory.

1.19 “Commercially Reasonable Efforts” means, with respect to the efforts to be
expended, or considerations to be undertaken, by a Party or its Affiliate with
respect to any objective, activity or decision to be undertaken hereunder,
reasonable, good faith efforts to accomplish such objective, activity or
decision as such Party would normally use to accomplish a similar objective,
activity or decision under similar circumstances, it being understood and agreed
that with respect to the Development or Commercialization of Products, such
efforts and resources shall be consistent with those efforts and resources
commonly used by a Party for a similar pharmaceutical product […***…].
Commercially Reasonable Efforts shall be determined on an
indication-by-indication basis for the Product, and it is anticipated that the
level of effort will change over time, reflecting changes in the status of the
Product in the Territory.

1.20 “Committee” means each of the JSC, the JDC, the JCC, and the JMC, or any
sub-Committees created pursuant to Section 5.5.

1.21 “Competitive Product Infringement” has the meaning set forth in
Section 9.3.1.

1.22 “Confidential Information” means all trade secrets, processes, formulae,
data, Know-How, improvements, inventions, chemical or biological materials,
chemical structures, techniques, marketing plans, strategies, customer lists,
Clinical Trial data (including CVOT PMR Study data) or other confidential or
proprietary information that is disclosed by a Party to the other Party,
regardless of whether any of the foregoing are marked “confidential” or
“proprietary” or communicated to the other Party by the Disclosing Party in
oral, written, graphic, or electronic form.

1.23 “Contrave” means the Orexigen proprietary formulation of bupropion
hydrochloride and naltrexone hydrochloride, formulated in an extended release
formulation, as described in NDA No. 20-0063.

1.24 “Controlled” or “Controls” means, when used in reference to Know-How,
Confidential Information, Patents or other intellectual property rights, the
legal authority or

 

- 5 -

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

FINAL VERSION

 

right of a Party (or any of its Affiliates) to grant a license or sublicense of
such Know-How or intellectual property rights to the other Party, or to
otherwise disclose such Know-How or Confidential Information to such other
Party, without breaching the terms of any agreement with a Third Party, or
misappropriating such Know-How or Confidential Information of a Third Party.

1.25 “Co-Promote” has the meaning set forth in Section 3.5.1.

1.26 “Co-Promote Agreement” means the agreement to be entered into by the
Parties in the event that Orexigen exercises its right to Co-Promote as set
forth in Section 3.5.1 or 3.5.2.

1.27 “Co-Promote Option” has the meaning set forth in Section 3.5.2.

1.28 “Cover(ed)” means, with respect to any Patent and the subject matter at
issue, that, but for a license granted under a Valid Claim in such Patent, the
manufacture, use, sale, offer for sale or importation of the subject matter at
issue would infringe such Valid Claim, or, in the case of a Patent that is a
patent application, would infringe a Valid Claim in such patent application if
it were to issue as a patent.

1.29 “Cure Period” has the meaning set forth in Section 12.2.1.

1.30 “CVOT PMR Study” means the randomized, double-blind, placebo-controlled
Clinical Trial to evaluate the effect of long-term treatment with Contrave on
the incidence of MACE in obese and overweight subjects with cardiovascular
disease that the FDA required in its Regulatory Approval of Contrave dated
September 10, 2014, which study shall meet the following requirements: (a) the
primary objective of this Clinical Trial shall be to demonstrate that the upper
bound of the 2-sided confidence interval for the estimated risk ratio comparing
the incidence of MACE observed with Contrave to that observed in the placebo
group is less than 1.4; (b) the Clinical Trial shall be designed to provide
sufficient data to reflect the “on treatment” cardiovascular risk associated
with Contrave; (c) the Clinical Trial shall be designed in a manner that allows
for completion in accordance with the timelines set by the FDA; and (d) any
other requirements for such Clinical Trial set forth by the FDA or that the
Parties mutually agree to include in such Clinical Trial.

1.31 “Dante License” means the License Agreement between Orexigen and Lee Dante,
M.D., dated June 1, 2004, as amended, and “Dante” means Lee Dante, M.D.

1.32 “Data Monitoring Committee” means, with respect to the CVOT PMR Study, the
data monitoring committee established and existing under a data monitoring
committee charter, which charter may be updated from time to time. […***…] shall
have the right to have […***…] representatives present at all open session
meetings of the Data Monitoring Committee and shall receive […***…] copy of all
open session meeting materials.

1.33 “Delivery of Launch Supplies” has the meaning set forth in Section 7.2.1.

1.34 “Development” means all non-clinical and clinical drug development
activities, each to the extent reasonably relating to the development of
Products in or for the

 

- 6 -

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

FINAL VERSION

 

Territory. Development shall include toxicology, pharmacology, and other
non-clinical efforts, test method development and stability testing, validation
batch development, manufacturing process development, formulation development,
delivery system development, quality assurance and quality control development,
statistical analysis, the conduct of Clinical Trials or other activities,
including Development Approval Activities and Development Post-Approval
Activities, relating to obtaining Regulatory Approval, as detailed in the
Development Plan for the Product. “Development” shall exclude all
Commercialization and Manufacturing activities. When used as a verb, “Develop”
means to engage in Development activities.

1.35 “Development Approval Activities” means all Development activities
conducted solely to the extent reasonably necessary to obtain the first, and
only the first, Regulatory Approval for the Product for the Initial Indication
in the Territory.

1.36 “Development Costs” means, except as otherwise set forth in this
Section 1.36, the […***…] costs incurred by a Party after the Original Effective
Date in connection with Development activities set forth in the Development Plan
and […***…]. Development Costs shall also include: (a) the cost of preparation,
filing, and maintenance of Regulatory Filings prior to receipt of the first, and
only the first, Regulatory Approval for the Product for the Initial Indication
in the Territory, and (b)(i) all […***…] incurred by Orexigen and (ii) all
[…***…], incurred by Takeda, in each of (i) and (ii) to the extent relating to
Manufacture of Product for Development activities. For the avoidance of doubt,
Development Costs relating to the Manufacture of Product by Orexigen or Takeda
shall be split in accordance with Section 2.2.2(b); by way of example, if
Orexigen incurs […***…] costs to Manufacture […***…] of Product […***…], but
such Product is used in […***…], Takeda shall be obligated to pay […***…]
percent ([…***…]%) of such Manufacturing costs pursuant to 2.2.2(b)(v).

1.37 “Development Plan” means a plan to be agreed upon by the Parties pursuant
to Section 2.2.1, that details the Development activities to be conducted
pursuant to this Agreement with respect to a Product during the Term, which plan
will outline the strategic Development objectives and activities for each
Product in the Territory, and contains a detailed budget identifying the
Development Costs associated with such Development activities.

1.38 “Development Post-Approval Activities” means all Development activities
other than Development Approval Activities. For the avoidance of doubt,
“Development Post-Approval Activities” includes Product formulation development
activities, post-marketing requirements (e.g., the CVOT PMR Study, Non-CVOT
PMRs) and other post-marketing Development activities (e.g., completion of the
Light Study, life cycle management activities, and Phase IV Trials).

1.39 “Disclosing Party” has the meaning set forth in Section 10.1.

1.40 “Disputes” has the meaning set forth in Section 13.1.

1.41 “Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.

 

- 7 -

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

FINAL VERSION

 

1.42 “EMA” means the European Medicines Agency, or any successor agency thereto.

1.43 “EU” means the European Union.

1.44 “Executive Officers” has the meaning set forth in Section 5.7.3.

1.45 “Executive Steering Committee” means with respect to the CVOT PMR Study,
the executive steering committee established and existing under the executive
steering committee charter, which charter may be updated from time to time.
[…***…] shall have the right to have […***…] representatives present at all open
session meetings of the Executive Steering Committee and shall receive […***…]
copy of all open session meeting materials.

1.46 “FDA” means the U.S. Food and Drug Administration, or any successor agency
thereto.

1.47 “Field” means the treatment or prevention of any and all Indications in
humans.

1.48 “First Commercial Sale” means, with respect to any Product, the first sale
of such Product invoiced to a Third Party in the Territory after Regulatory
Approval of such Product has been granted.

1.49 “Force Majeure” has the meaning set forth in Section 14.4.

1.50 “GAAP” means generally accepted accounting principles in the United States
or Japan, consistently applied.

1.51 “Generic Competition” means, with respect to all Products in the Territory,
in […***…] consecutive […***…], if, during such […***…] consecutive […***…]
period, one (1) or more Generic Products are sold in the Territory and units of
the Generic Product(s) sold account for more than […***…] percent ([…***…]%) of
the sum of: (a) all […***…] of […***…] sold in the Territory, and (b) all
[…***…] of the Generic Products sold in the Territory, in each case based on
[…***…] for such […***…].

1.52 “Generic Product” means, on a Product-by-Product basis, any pharmaceutical
product sold by a Third Party in the Territory, other than pursuant to a
sublicense from Takeda, which: (a) contains the […***…] the applicable Product
in […***…] and in the […***…] as the applicable Product, […***…] (b) is […***…]
with respect to such Product in the Territory. For the purposes of this
definition, […***…].

 

- 8 -

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

FINAL VERSION

 

1.53 “Good Clinical Practices” or “GCP” means the standards, practices and
procedures set forth in the International Conference on Harmonization guidelines
entitled in “Good Clinical Practice: Consolidated Guideline,” including related
regulatory requirements imposed by the FDA and (as applicable) any equivalent or
similar standards in jurisdictions outside the United States, to the extent that
such standards are applicable in the jurisdiction in which the relevant Clinical
Trial is conducted or required to be followed in the jurisdiction in which
Regulatory Approval of a product will be sought.

1.54 “Good Laboratory Practices” or “GLP” means the regulations set forth in 21
C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by
the FDA and (as applicable) any equivalent or similar standards in jurisdictions
outside the United States.

1.55 “Good Manufacturing Practices” or “GMP” means the regulations set forth in
21 C.F.R. Parts 210–211, and the requirements thereunder imposed by the FDA,
and, as applicable, any similar or equivalent regulations and requirements in
jurisdictions outside the United States.

1.56 “GSK Field” means the […***…].

1.57 “GSK License” means the License Agreement between Orexigen and GSK,
effective June 10, 2009, as amended, and “GSK” means SmithKline Beecham
Corporation, doing business as GlaxoSmithKline, a Pennsylvania corporation
located at One Franklin Plaza, Philadelphia, PA 19102 and Glaxo Group Limited, a
private limited company incorporated in England and Wales, having its registered
office at Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, England
UB6 0NN.

1.58 “Hatch-Waxman Act” has the meaning set forth in Section 9.4.

1.59 “HSR Act” has the meaning set forth in Section 14.1.

1.60 “IFRS” means the International Financial Reporting Standards.

1.61 “Improvement” means any Invention that is incorporated into, used in
connection with, or relates to the Product, whether or not protected by a
Patent.

1.62 “IND” means any Investigational New Drug application, as contemplated by
Section 505(i) of the United States Federal Food, Drug, and Cosmetic Act, as
amended from time to time, and the regulations promulgated thereunder, filed
with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal
Regulations, including any amendments thereto. References herein to IND shall
include, to the extent applicable, any comparable filing(s) outside the United
States necessary to commence or conduct Clinical Trials.

1.63 “Indemnification Claim” has the meaning set forth in Section 11.3.

1.64 “Indemnitee” has the meaning set forth in Section 11.3.

1.65 “Indemnitor” has the meaning set forth in Section 11.3.

 

- 9 -

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

FINAL VERSION

 

1.66 “Indication” means any disease or condition which could be listed under the
header “INDICATIONS AND USAGE” or described under the header “CLINICAL STUDIES”
of a Product’s label upon Regulatory Approval, or equivalent thereof in the
event applicable Laws are modified.

1.67 “Initial Co-Promote Period” has the meaning set forth in Section 3.5.1.

1.68 “Initial Indication” means the disease or condition for which Contrave is
first approved by the FDA, as described under the header “INDICATIONS AND USAGE”
in the first approved labeling for Contrave.

1.69 “Initiation” or “Initiate” means, when used with respect to Clinical
Trials, the dosing of the first human patient with the first dose in such
Clinical Trials.

1.70 “Inventions” has the meaning set forth in Section 9.1.1.

1.71 “IPR Proceedings” has the meaning set forth in Section 9.2.1.

1.72 “Joint Invention” has the meaning set forth in Section 9.1.1.

1.73 “Joint Patent” has the meaning set forth in Section 9.1.1.

1.74 “JCC” has the meaning set forth in Section 5.3.1.

1.75 “JDC” has the meaning set forth in Section 5.2.1.

1.76 “JMC” has the meaning set forth in Section 5.4.1.

1.77 “JSC” has the meaning set forth in Section 5.1.1.

1.78 “Know-How” means technical information and know-how, including biological,
chemical, pharmacological, and toxicological information, know-how and trade
secrets, and manufacturing data, preclinical data, Clinical Trial data, the
specifications of ingredients, the manufacturing processes, formulation,
specifications, sourcing information, quality control and testing procedures,
and related know-how and trade secrets.

1.79 “Launch Supplies” means the full quantity of Product in finished bulk form
(30 gallon HDPE drums or in such other finished bulk form as agreed to by the
Parties), by dosage strength, ordered by Takeda for commercial launch of Product
in the Territory, which at the time of Delivery (of Launch Supplies), will have
a minimum of nine (9) months remaining shelf life and will comply with the terms
of the Manufacturing Services Agreement.

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

1.81 “Licensed Compounds” means bupropion hydrochloride and naltrexone
hydrochloride, including all drug forms, formulations and salts thereof.

 

- 10 -

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

FINAL VERSION

 

1.82 “Light Study” means the terminated Orexigen study NB-CVOT which was a
multicenter, double-blind, placebo-controlled study assessing the occurrence of
MACE in overweight and obese subjects with cardiovascular risk factors receiving
naltrexone SR/bupropion SR.

1.83 “Losses and Claims” has the meaning set forth in Section 11.1.

1.84 “MACE” means major adverse cardiovascular events, including non-fatal
myocardial infarction, non-fatal stroke, and cardiovascular death.

1.85 “Manufacture” with a correlative meaning for “Manufacturing,” means all
activities related to the manufacturing of a pharmaceutical product, or any
ingredient thereof, including manufacturing Product in finished form for
Development, manufacturing finished Product for Commercialization, labelling,
packaging, in-process and finished Product testing, validation, process
improvement, and process development, release of Product or any component or
ingredient thereof, quality assurance activities related to manufacturing and
release of Product, ongoing stability tests and regulatory activities related to
any of the foregoing. “Manufacturing” shall include Commercial Packaging.

1.86 “Manufacturing Responsibility Transition Plan” has the meaning set forth in
Section 4.2.

1.87 “Manufacturing Services Agreement” has the meaning set forth in
Section 4.1.

1.88 “NDA” means a New Drug Application or supplemental New Drug Application as
contemplated by Section 505(b) of the United States Federal Food, Drug, and
Cosmetic Act, as amended from time to time, and the regulations promulgated
thereunder, submitted to the FDA pursuant to Part 314 of Title 21 of the U.S.
Code of Federal Regulations, including any amendments thereto.

1.89 “Net Sales” means, with respect to a particular time period, the total
amounts invoiced to Third Parties by Takeda, its Affiliates or Sublicensees for
sale or other distribution of Products made during such time period to Third
Parties in the Territory, less the following deductions to the extent actually
allowed or incurred with respect to such sales:

(a) sales returns and allowances, including trade, quantity and cash discounts
and any other adjustments, including those granted on account of price
adjustments, billing errors, bad debt expense (i.e., non-payment on an account
receivable) not to exceed an amount equal to […***…] percent ([…***…]%) of such
total amounts invoiced, rebates, chargebacks, fees, reimbursements or similar
payments actually granted or given to wholesalers or other distributors, buying
groups, healthcare insurance carriers or other institutions, federal, state, or
local government and the agencies, and reimbursers of managed health
organizations;

(b) credits or allowances actually granted upon damaged goods, rejections, or
returns of such Products, including in connection with recalls;

 

- 11 -

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

FINAL VERSION

 

(c) freight, postage, shipping, transportation, and insurance charges actually
allowed or paid for delivery of Products, to the extent billed; and

(d) taxes (other than income or withholding taxes), duties, tariffs, or other
governmental charges levied on the sale of such Products to the extent billed,
including value-added taxes and annual fees paid pursuant to the U.S. Affordable
Care Act, dated March 23, 2010 (as amended), net of all reimbursements and
allowances.

Notwithstanding the foregoing, amounts billed by Takeda, its Affiliates or
Sublicensees for the sale of Products among Takeda, its Affiliates or
Sublicensees for resale shall not be included in the computation of Net Sales
hereunder. Net Sales shall be accounted for in accordance with GAAP or IFRS, as
applicable. Net Sales shall exclude any samples of Product transferred or
disposed of at no cost for promotional or educational purposes.

In the case of any Combination Product in the Territory, Net Sales for such
Combination Product in the Territory shall be calculated as follows:

(i) If Product and other clinically active ingredient(s) each are sold
separately in the Territory, Net Sales will be calculated by multiplying the
total Net Sales (as described above) of the Combination Product by the fraction
A/(A+B), where A is the average invoice price in the Territory of the Product
sold separately in the same formulation and dosage, and B is the sum of the
average invoice prices in the Territory of such other clinically active
ingredient(s) sold separately in the same formulation and dosage, during the
applicable Calendar Year.

(ii) If the Product is sold independently of the other clinically active
ingredient(s) therein in the Territory, but the average invoice price of such
other clinically active ingredient(s) cannot be determined, Net Sales will be
calculated by multiplying the total Net Sales (as described above) of the
Combination Product by the fraction A/C where A is the average invoice price in
the Territory of such Product sold independently and C is the average invoice
price in the Territory of the entire Combination Product.

(iii) If the other clinically active ingredient(s) are sold independently of the
Product therein in the Territory, but the average invoice price of such Product
cannot be determined, Net Sales will be calculated by multiplying the total Net
Sales (as described above) of the Combination Product by the fraction [1-B/C],
where B is the average invoice price in the Territory of such other clinically
active ingredient(s) and C is the average invoice price in the Territory of the
entire Combination Product.

1.90 “Non-Breaching Party” has the meaning set forth in Section 12.2.1.

1.91 “Non-CVOT PMR Study” means any Clinical Trial or non-clinical study, other
than the CVOT PMR Study, that is required by the FDA to maintain Regulatory
Approval of Contrave.

1.92 “OHSU Agreement” means the License Agreement between Orexigen and OHSU,
dated June 27, 2003, as amended, and “OHSU” means the Oregon Health & Science
University, having offices at 2525 SW 1st Ave, Portland, Oregon 97201.

 

- 12 -

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

FINAL VERSION

 

1.93 “Orange Book” has the meaning set forth in Section 9.5.1.

1.94 “Orexigen Indemnitees” has the meaning set forth in Section 11.1.

1.95 “Orexigen Intellectual Property” means the Orexigen Patents and the
Orexigen Know-How.

1.96 “Orexigen Invention Patent” has the meaning set forth in Section 9.1.1.

1.97 “Orexigen Know-How” means all Know-How Controlled by Orexigen or its
Affiliates as of the Original Effective Date or at any time during the Term that
[…***…] for the Development or Commercialization. For clarity, the Orexigen
Know-How does not include rights with respect to any active ingredient in a
Combination Product other than rights to the Product.

1.98 “Orexigen Logo” has the meaning set forth on Exhibit 1.98.

1.99 “Orexigen Patents” means any and all (a) Patents that are Controlled by
Orexigen or its Affiliates as of the Original Effective Date in the Territory as
set forth on Exhibit 1.99, including the Upstream Patents set forth on Exhibit
1.99 (which Upstream Patents are subject to the respective terms and conditions
of the applicable Upstream Agreement); and (b) other Patents that (i) are
Controlled by Orexigen or its Affiliates in the Territory during the Term and
(ii) Cover a Product. Orexigen Patents include the Orexigen Invention Patents
and Orexigen’s interest in Joint Patents. For clarity, the Orexigen Patents do
not include rights with respect to any active ingredient in a Combination
Product other than rights to the Product.

1.100 “Orexigen Trademark” has the meaning set forth in Section 3.8.2.

1.101 “Original Collaboration Agreement” has the meaning set forth in the
recitals of this Agreement.

1.102 “Original Effective Date” has the meaning set forth in the recitals of
this Agreement.

1.103 “Paragraph IV Certification” has the meaning set forth in
Section 9.3.2(c).

1.104 “Patents” means U.S. patents and patent applications and (a) any foreign
counterparts thereof, (b) all divisionals, continuations, continuations in-part
thereof or any other patent or patent application claiming priority directly or
indirectly to (i) any such specified patents or patent applications or (ii) any
patent or patent application from which such specified patents or patent
applications claim direct or indirect priority, and (c) all patents issuing on
any of the foregoing, and any foreign counterparts thereof, together with all
registrations, reissues, re-examinations, renewals, supplemental protection
certificates, or extensions of any of the foregoing, and any foreign
counterparts thereof; provided, however, that continuations-in-part of the
Upstream Patents are only included to the extent that the subject matter claimed
in each such continuation-in-part is described in and enabled by the disclosure
of an Upstream Patent to which any particular continuation-in-part claims
priority.

 

- 13 -

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

FINAL VERSION

 

1.105 “Patheon Agreement” means the Manufacturing Services Agreement entered
into as of March 12, 2010 among Patheon Pharmaceuticals Inc., Patheon Inc., and
Orexigen, as amended.

1.106 “PDE Term” has the meaning set forth in Section 3.2.1.

1.107 “PDE Cost” means […***…] percent ([…***…]%) of Takeda’s […***…] cost for
each PDE performed by Orexigen, as set forth in paragraph 2 of Exhibit 3.5.3.

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

1.109 “Pharmacovigilance Agreement” has the meaning set forth in Section 3.6.

1.110 “Phase IV Trial” means a human clinical trial of a pharmaceutical product
Initiated after receipt of Regulatory Approval in the Territory and that is
conducted within the parameters of the Regulatory Approval for the
pharmaceutical product. Phase IV Trials may include epidemiological studies,
registries, modeling and pharmacoeconomic studies of pharmaceutical product and
post-marketing surveillance studies.

1.111 “Primary Detail Equivalent” or “PDE” means a primary detail equivalent for
the Product equal to […***…] Detail or […***…] Details. For the avoidance of
doubt, details that are not […***…] Details or […***…] Details have no Primary
Detail Equivalents. A “[…***…] Detail” means a detail delivered by a Sales
Representative face-to-face to a contact target in which the promotional message
involving the Product is […***…] Detail” means a detail delivered by a Sales
Representative face-to-face to a contact target in which the promotional message
involving the Product is […***…]. For the avoidance of doubt, electronic and
telemarketing details are not Primary Detail Equivalents.

1.112 “Product” means any pharmaceutical composition, branded or generic,
containing the Licensed Compounds, including any Improvements to such
composition. “Product” shall include Contrave. “Product” shall include
“Combination Products.”

1.113 “Product Plan” means the then-current Development Plan together with the
then-current Commercialization Plan for a Product.

1.114 “Product Trademarks” has the meaning set forth in Section 3.8.1.

1.115 “Publication Manager” has the meaning set forth in Section 10.7.1.

1.116 “Quality Agreement” has the meaning set forth in Section 4.1.

1.117 “Quarterly Report” has the meaning set forth in Section 2.2.2(c).

 

- 14 -

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

FINAL VERSION

 

1.118 “Receiving Party” has the meaning set forth in Section 10.1.

1.119 “Regulatory Approval” means, with respect to any Product in the Territory,
approval by a Regulatory Authority of an NDA.

1.120 “Regulatory Authority” means any national or supranational governmental
authority, including the FDA, that has responsibility or authority in the
Territory to regulate the development, manufacture, sale or promotion of
pharmaceutical products.

1.121 “Regulatory Filings” means any and all regulatory applications, filings,
approvals and associated correspondence submitted to or received from a
Regulatory Authority to further the Development or Commercialization of Products
in, or into, the Territory.

1.122 “Royalty Term” means, on a Product-by-Product basis, the period commencing
on the First Commercial Sale of a Product in the Territory and ending upon the
later of: (i) the earliest date upon which both of the following have occurred:
(a) the expiration of the last to expire of all Collaboration Patents containing
a Valid Claim Covering the composition of matter or method of manufacture or use
of such Product (or any Licensed Compound therein), and (b) the expiration of
all applicable exclusivity extensions, including pediatric or data exclusivity,
in the Territory with respect to such Product (such as those periods listed in
the FDA’s Orange Book; or (ii) […***…] years after First Commercial Sale of such
Product in the Territory.

1.123 “Sales Representatives” means sales representatives employed by a Party,
or employed or contracted by a Third Party that is contracted by a Party to
provide sales representatives, to detail and promote the Product in the
Territory.

1.124 “Secondary Co-Promote Period” has the meaning set forth in Section 3.5.2.

1.125 “SOPs” has the meaning set forth in Section 3.7.

1.126 “Standstill Period” has the meaning set forth in Section 8.6.3(a).

1.127 “Sublicense” means a written agreement pursuant to which a Third Party
became a Sublicensee.

1.128 “Sublicensee” means (a) any Third Party granted a sublicense by Takeda of
any of the rights licensed to Takeda by Orexigen under Section 6.1, including
any Third Party to whom Takeda has granted the right to promote or distribute a
Product if such Third Party is principally responsible for marketing and
promotion of such Product in the Territory, or (b) any Third Party granted a
sublicense by Orexigen of any of the rights granted to it by Takeda hereunder.

1.129 “Superiority” means, with respect to the CVOT PMR Study, demonstration of
a […***…] reduction in the incidence of […***…] that, according to FDA, will
serve as a […***…] to establish a […***…] for Contrave that includes […***…].

 

- 15 -

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

FINAL VERSION

 

1.130 “Superiority Claim” means Regulatory Approval of a labeled claim for
Contrave that includes an indication for […***…].

1.131 “Takeda Indemnitees” has the meaning set forth in Section 11.2.

1.132 “Takeda Intellectual Property” means the Takeda Know-How and the Takeda
Patent(s).

1.133 “Takeda Invention Patent” has the meaning set forth in Section 9.1.1.

1.134 “Takeda Know-How” means all Know-How Controlled by Takeda or its
Affiliates as of the Original Effective Date or at any time during the Term that
is […***…] for the composition of matter, method of making or using, or
formulation of a Product, other than the Orexigen Know-How.

1.135 “Takeda Patents” means any and all Patents that are Controlled by Takeda
or its Affiliates as of the Original Effective Date in the Territory or at any
time during the Term in the Territory and claim or disclose (a) compositions of
matter comprising a Product, or methods of treatment comprising the
administration of a Product, or (b) the manufacture, formulation, delivery, use,
sale, offer for sale or importation of a Product. Takeda Patents include the
Takeda Invention Patents and Takeda’s interest in Joint Patents.

1.136 “Takeda Trademark” has the meaning set forth in Section 3.8.3.

1.137 “Term” has the meaning set forth in Section 12.1.

1.138 “Territory” means the United States.

1.139 “Third Party” means any Person other than Takeda, Orexigen, or their
respective Affiliates.

1.140 “Third Party License” has the meaning set forth in Section 9.7.3.

1.141 “Third Party Manufacturers” has the meaning set forth on Exhibit 8.2.12 of
this Agreement, and Section 2.3.1 and Exhibit 2.3.1 of the Manufacturing
Services Agreement, which Exhibit 2.3.1 of the Manufacturing Services Agreement
may be updated from time to time.

1.142 “United States” or “U.S.” means the United States of America and all its
territories and possessions.

1.143 “Upstream Agreements” means (a) the Dante License, (b) the GSK License,
and (c) the OHSU Agreement. For clarity, as of the Amended and Restated
Effective Date, the Dante License and the GSK License have expired in accordance
with their terms.

1.144 “Upstream Party” means, respectively, (a) Dante with respect to the Dante
License, (b) GSK with respect to the GSK License, and (c) OHSU with respect to
the OHSU Agreement.

 

- 16 -

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

FINAL VERSION

 

1.145 “Upstream Patents” means the Patents licensed or assigned to Orexigen
under the Upstream Agreements, and any Patents claiming priority therefrom,
subject to the provisions regarding continuations-in-part of Upstream Patents as
set forth in Section 1.104.

1.146 “USPTO” has the meaning set forth in Section 8.2.7.

1.147 “Valid Claim” means a claim within a Patent application filed in or for
the Territory or an issued Patent in or for the Territory, in each case within
the Collaboration Patents, that (i) is not expired, lapsed, or abandoned,
(ii) is not dedicated to the public, disclaimed, or admitted to be unenforceable
or invalid; and (iii) has not been invalidated, held unenforceable or cancelled
by a court or administrative agency of competent jurisdiction in an order or
decision from which no appeal has been or can be taken, including through
opposition, re-examination, reissue, disclaimer or otherwise.

1.148 Construction. Except where expressly stated otherwise in this Agreement,
the following rules of interpretation apply to this Agreement: (a) “include,”
“includes” and “including” are not limiting and shall be deemed to be followed
by “without limitation”; (b) definitions contained in this Agreement are
applicable to the singular as well as the plural forms of such terms;
(c) references to a statute mean such statute as from time to time amended,
modified or supplemented; (d) references to a Person are also to its permitted
successors and assigns; (e) captions, the plain meaning of defined terms to the
extent different from the definitions provided in Article 1, and other headings
to this Agreement are for convenience only, and shall have no force or effect in
construing or interpreting any of the provisions of this Agreement or any other
legal effect; (f) references to “Article”, “Section”, or “Exhibit” refer to an
Article or Section of, or an Exhibit to, this Agreement, unless otherwise
indicated; (g) the word “will” shall be construed to have the same meaning and
effect as the word “shall” and vice versa; and (h) the word “or” has, except
where otherwise indicated, the inclusive meaning represented by the phrase
“and/or”.

2. DEVELOPMENT

2.1 Overview. The Parties shall undertake Development in accordance with a
Development Plan as provided for herein consisting of conducting Clinical Trials
and other Development activities.

2.1.1 Commercially Reasonable Efforts. Each Party shall use Commercially
Reasonable Efforts to Develop each Product in accordance with the Development
Plan, including in completion of activities assigned to each Party in the
Development Plan. Additionally, and without limiting the foregoing, if the
[…***…] achieves […***…], Takeda shall use […***…] to submit for, and obtain, a
[…***…]. Each Party will participate in the oversight of Development via
membership in the JSC and the JDC.

2.1.2 Annual Review of Development Progress. On an annual basis, the JDC shall
consider the Development progress of the Product, objectives of the Development
Plan and economic factors impacting Product Development and adjust the
Development Plan to reflect the then-current conditions.

 

- 17 -

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

FINAL VERSION

 

2.1.3 Audit Rights.

(a) Not more than […***…] per Calendar Year, each Party shall have the right to
conduct an audit of the other Party’s compliance with this Section 2.1,
including with respect to Development Costs incurred in connection with
activities conducted in the execution of the Development Plan, for purposes of
confirming the Development Costs reflected in Quarterly Reports contemplated in
Section 2.2.2(c). Such audit shall be conducted during normal business hours,
upon not less than […***…] ([…***…]) Business Days prior notice, and no more
than […***…] with regard to any given Calendar Year. As appropriate, prompt
adjustments to payments made pursuant to Section 2.2.2(c) shall be made by the
Parties to reflect the results of such audit. The Party to whom payment is owed
will issue an invoice to the other Party. Such invoice will be paid within
[…***…] days of receipt. The auditing Party shall bear the full cost of such
audit unless such audit discloses an over-reporting by the audited Party of more
than […***…] percent ([…***…]%) of the amount of Development Costs for a given
Calendar Quarter, in which case, the audited Party shall bear the full cost of
such audit. Notwithstanding anything to the contrary contained in this
Section 2.1.3, each Party’s audit shall be limited to the review of information
directly relating to Development activities.

(b) Each Party shall have the right to conduct an inspection and audit of the
other Party’s compliance with this Section 2.1 and Section 2.2.7, including with
respect to any Development activities carried out by subcontractors of a Party.
Such inspection and audit shall be conducted during normal business hours, upon
not less than […***…] ([…***…]) Business Days prior notice, and not more than
[…***…] per Calendar Year; provided, however, if an adverse issue arises in
connection with the Development activities of the Party to be audited, then such
inspection or audit may be conducted more than […***…] per Calendar Year. The
auditing Party shall bear the full cost of such audit. The audited Party shall
use Commercially Reasonable Efforts to resolve any material audit findings as
promptly as possible.

2.2 Development.

2.2.1 Development Plan. The initial Development Plan shall be agreed upon by the
Parties within […***…] after the Original Effective Date. The Development Plan
shall be consistent with the obligations of the Parties under Sections 2.1 and
2.2.2 through 2.2.9. The Development Plan may be updated or amended only as
agreed by the Parties in writing […***…]. The Development Plan will set forth a
budget and all Development Costs associated with the Development Plan,
consistent with Sections 2.1.2 and 2.2.2. The Parties agree to update the
Development Plan to include the CVOT PMR Study, Non-CVOT PMR Studies, and other
Development Post-Approval Activities pursuant to this Section 2.2.1.

2.2.2 Development Costs.

(a) Orexigen shall bear all Development Costs incurred by either or both of the
Parties in the conduct of […***…].

(b) The Parties have shared all Development Costs incurred prior to August 1,
2015 by either or both of the Parties in the conduct of Development Post-

 

- 18 -

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

FINAL VERSION

 

Approval Activities in accordance with Section 2.2.2(b) of the Original
Collaboration Agreement. As of August 1, 2015, the Parties shall share all
Development Costs incurred from and after August 1, 2015 by either or both of
the Parties in the conduct of […***…] during the Term as follows:

(i) Orexigen shall bear all such Development Costs incurred by Takeda (and all
Development Costs incurred by Orexigen with respect to the Manufacture of
Product for the CVOT PMR Study by its Third Party Manufacturer(s)) in the
conduct of the CVOT PMR Study up to an aggregate amount equal to Two Hundred Ten
Million Dollars ($210,000,000).

(ii) After Orexigen has borne Two Hundred Ten Million Dollars ($210,000,000) of
Development Costs incurred by Takeda (and Development Costs incurred by Orexigen
with respect to the Manufacture of Product for the CVOT PMR Study by its Third
Party Manufacturer(s)) in the conduct of the CVOT PMR Study, each Party shall
bear fifty percent (50%) of such Development Costs incurred by Takeda (and
Development Costs incurred by Orexigen with respect to the Manufacture of
Product for the CVOT PMR Study by its Third Party Manufacturer(s)) in the
conduct of the CVOT PMR Study.

(iii) Notwithstanding Section 2.2.2(b)(i) and (ii), if Takeda and Orexigen agree
to amend the design of the CVOT PMR Study (and for clarity, the Development
Plan) […***…].

(iv) Notwithstanding Section 2.2.2(b)(i) and (ii), subject to approval by the
FDA, if the […***…] approves an amended Development Plan, which includes an
amendment to the CVOT PMR Study such that it is designed to achieve Superiority,
then in such case, […***…]

 

- 19 -

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

FINAL VERSION

 

[…***…].

(v) Takeda shall bear seventy-five percent (75%) and Orexigen shall bear
twenty-five percent (25%) of such Development Costs incurred by either or both
of the Parties in the conduct of (a) Non-CVOT PMR Studies; (b) life cycle
management activities; and (c) Development Post-Approval Activities other than
as provided in Section 2.2.2(b)(i), (ii), (iii) and (iv), and
Section 2.2.2(b)(vi).

(vi) Takeda shall bear all such Development Costs incurred by Takeda (and all
Development Costs incurred by Orexigen with respect to the Manufacture of
Product for the Light Study by its Third Party Manufacturer(s)) in the conduct
of activities related to the Light Study.

(c) Within […***…] ([…***…]) days after the end of each Calendar Quarter, each
Party will provide a written report to the other Party setting forth in
reasonable detail the recorded Development Costs relating to such Calendar
Quarter (each, a “Quarterly Report”). Within […***…] ([…***…]) days after the
end of such Calendar Quarter, the Parties will agree upon the Development Costs
incurred in such Calendar Quarter and any amount required to be paid to give
effect to Section 2.2.2(b). Such amount shall be paid within […***…] ([…***…])
days after the Parties agree upon such amount.

(d) In the event either Orexigen or Takeda discover a need for correction in
calculating the amount of Development Costs incurred by such Party during any
previous […***…], it will promptly notify the other Party of such discovery. The
Parties will then discuss the validity and appropriateness of the correction. If
the Parties agree that such correction should be made and mutually verify the
amount to be corrected, then such amounts shall be included in the following
[…***…] reconciliation between the Parties as set forth in Section 2.2.2(c);
provided, however, only corrections for Development Costs that have occurred in
the previous […***…] prior to the date of the notice described in the first
sentence of this subsection (d) shall be eligible for correction. If the Parties
do not agree on the validity or appropriateness of the requested correction, the
JDC will be responsible for deciding the issue.

(e) Each Party will use Commercially Reasonable Efforts to complete the
Development activities contemplated in the Development Plan and related budget,
and to do so within the amounts budgeted. The Parties acknowledge that actual
expenditures may differ from budgeted amounts, and accordingly agree that the
aggregate amount actually spent by a Party may be up to […***…] percent
([…***…]%) higher than the amount specified in the budget. In the event a
Party’s Development Costs in the aggregate exceed the amount budgeted in any
Development Plan by more than […***…] percent ([…***…]%), the JDC shall
determine if such excess amount is reasonable under the circumstances. If the
JDC determines such excess amounts are reasonable, such amounts shall be deemed
Development Costs; otherwise, the excess shall be borne by the Party that
incurred such excess Development Costs.

2.2.3 Cooperation. Each Party will use Commercially Reasonable Efforts to
provide the other Party with all reasonable assistance and take all actions
reasonably

 

- 20 -

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

FINAL VERSION

 

requested by such other Party, without changing the allocation of
responsibilities assigned in the Development Plan, that are necessary or
desirable to enable the other Party to comply with the terms and conditions of
this Agreement.

2.2.4 Development Responsibilities.

(a) Each Party will perform, on a Calendar Year basis, the Development
activities to be conducted by such Party as set forth in the Development Plan;
provided, however, for the avoidance of doubt, during the process of determining
which Party will perform the Development activities set forth in the Development
Plan, in no event shall a Party be required to perform a particular Development
activity that it does not then possess reasonable resources or capabilities to
perform. Except as set forth in Section 2.2.4(b) of this Agreement, Orexigen
shall have the right to perform, on a Calendar Year basis, at least […***…]
percent ([…***…]%) of the activities set forth in the applicable Development
Plan, as determined based on the percentage of Development Costs associated with
such Development activities set forth in the Development Plan for such Calendar
Year.

(b) Takeda shall be solely responsible for the performance of, and shall have
the sole right to conduct, all Development activities related to the (i) CVOT
PMR Study and (ii) Light Study. The Parties acknowledge and agree that as of the
Amended and Restated Effective Date, the current design of the CVOT PMR Study
satisfies FDA and, to the Parties’ knowledge, EMA requirements for, and to
support and maintain, Regulatory Approval in the Territory and regulatory
approval in the EU. Takeda agrees to consider in good faith amendments to the
current design of the CVOT PMR Study proposed by Orexigen to the extent Takeda
deems such proposed amendments as necessary to maintain Orexigen’s regulatory
approval in the EU; provided, however, that any such amendment to the current
design of the CVOT PMR Study is subject to approval by the FDA, and any
incremental Development Costs related to any such amendment shall be borne
solely by Orexigen to the extent provided in Section 2.2.2(b)(iii). For the
avoidance of doubt, Takeda has final decision-making authority pursuant to
Section 5.7.3(a)(i) with respect to a Dispute regarding Development
Post-Approval Activities, including with respect to the design of the CVOT PMR
Study.

(c) Notwithstanding anything to the contrary in this Agreement, Orexigen shall
have the right to conduct in the Territory (i) Clinical Trial (NB-240) under the
Takeda IND for Contrave in the Territory, which Clinical Trial is solely
intended to demonstrate the bioequivalence of the Contrave manufactured at
Orexigen’s third party manufacturer, Sanofi Winthrop Industrie, to the Contrave
that is Manufactured at Orexigen’s Third Party Manufacturer, Patheon, and
(ii) as mutually agreed upon in writing by the Parties, other Clinical Trials
under an Orexigen IND in the Territory that cross-references the Takeda IND for
Contrave in the Territory, which Clinical Trials are solely intended to
demonstrate bioequivalence.

2.2.5 Development Reports. Each Party will provide the JDC with written
Development reports or presentations at JDC meetings at the request of the other
Party’s JDC members. Each report or presentation shall include the Development
activities accomplished by or on behalf of such Party since the previous JDC
meeting, and other relevant matters, including a summary of significant results,
information, and data generated, or

 

- 21 -

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

FINAL VERSION

 

significant challenges relating to Products, and the status of Development
activities as compared to the timelines in the Development Plan. Such reports
may also include summaries of the costs incurred by such Party in the
performance of such Development activities prior to the date of such report.
Upon request by the JDC, each Party shall provide the JDC with summaries of
available Clinical Trial protocols, investigator brochures, non-clinical
protocols and reports (including activities relating to CMC), regulatory
submissions and correspondence from Regulatory Authorities with respect to
Products.

2.2.6 Records. In conformity with standard pharmaceutical industry practices and
the terms and conditions of this Agreement, each Party shall prepare and
maintain, and shall cause its Affiliates and Sublicensees to prepare and
maintain, complete and accurate written records, accounts, notes, reports and
data with respect to activities conducted pursuant to the Development Plan for a
minimum of […***…] ([…***…]) years following the end of the Calendar Year to
which they pertain, or for such longer period of time as required under
applicable Laws; provided, further, upon the other Party’s written request, the
non-requesting Party shall provide legible copies of such written records,
accounts, notes, reports and data to the requesting Party throughout the Term
and for a minimum of […***…] ([…***…]) years following the Term, or for such
longer period of time as such written records, accounts, notes, reports and data
are required to be maintained under applicable Laws. Upon reasonable advance
notice, at the request of the JDC, each Party agrees to make its employees and
contractors reasonably available at their respective places of employment to
consult with the other Party on issues arising in connection with Development
activities.

2.2.7 Development Standards. Each Party shall conduct all such Development
activities in compliance with applicable Laws, including GCP, GLP, and all legal
and regulatory requirements pertaining to the design and conduct of Clinical
Trials.

2.2.8 Subcontracting. Each Party may perform any activities in support of its
Development under this Agreement through subcontracting to a Third Party
contractor or contract service organization; provided that: (a) none of the
rights of the other Party hereunder are materially adversely affected as a
result of such subcontracting; (b) any such Third Party subcontractor to whom
such Party discloses Confidential Information shall be bound by an appropriate
written agreement obligating such Third Party to obligations of confidentiality
and restrictions on use of such Confidential Information that are no less
restrictive than the obligations in Article 10; (c) such Party will obligate
such Third Party to agree in writing to assign or license (with the right to
grant sublicenses) to such Party any inventions (and Patents covering such
inventions) made by such Third Party in performing such services for such Party
that are necessary for the Development; (d) such Party shall at all times be
responsible for the performance of such subcontractor; and (e) […***…]. At
Orexigen’s request, Takeda shall use Commercially Reasonable Efforts to […***…].

 

- 22 -

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

FINAL VERSION

 

2.2.9 Information Sharing.

(a) Each Party shall provide the other Party with copies of all material
non-clinical, analytical, Manufacturing, and Clinical Trial data (including, for
clarity, data sets […***…] and information relating to the Product generated by
such Party in or for the […***…], or on behalf of such Party by any Third Party,
promptly after such data and information are deemed final in the […***…] of the
Disclosing Party; provided, that (i) Clinical Trial data shall be deemed final
only after the Disclosing Party has had a […***…], and (ii) when […***…], the
Disclosing Party shall make such […***…] available to the other Party. Without
limiting the foregoing, […***…] will use […***…] to provide […***…] with, and
allow […***…] to use, […***…] for the purposes of satisfying […***…], provided,
that, with respect to the […***…], to the extent that (iii) […***…] does not
have access to such […***…], the Data Monitoring Committee grants […***…] access
to such data and information for such purpose, or (iv) […***…] has access to
such […***…], the Data Monitoring Committee approves the disclosure of such data
and information to […***…] for such purpose. Notwithstanding the foregoing,
[…***…] agrees to provide […***…] with the Data Monitoring Committee […***…] to
[…***…], the final Data Monitoring Committee charter and performance metrics as
set forth in the performance standards document for the CVOT PMR Study, as such
document may be revised from time to time, promptly after it is available to
Takeda. The information sharing provisions in this Section 2.2.9 are in addition
to provisions regarding sharing of information by the Committees in Article 5
and publications in Section 10.7.

(b) Without limiting the foregoing Section 2.2.9(a), with respect to any
Clinical Trial of a Product:

(i) that is conducted by either Party for the Territory (i.e., either in or
outside the Territory) pursuant to this Agreement under an IND for Contrave, the
Party conducting such Clinical Trial will provide the other Party with the
opportunity to […***…] for such Clinical Trial […***…] such […***…] being deemed
final by the Parties, and such Party will give […***…] to any comments provided
by the other Party;

(ii) that is conducted by either Party for the Territory (i.e., either in or
outside the Territory) pursuant to this Agreement which is not required to be
conducted under an IND for Contrave, each Party shall provide the other Party
with (A) […***…]; and (B) […***…];

 

- 23 -

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

FINAL VERSION

 

(iii) that is conducted by Orexigen in the Territory, for outside the Territory,
under an Orexigen IND for Contrave, […***…] shall provide to […***…] (A) the
opportunity to […***…], and […***…]; and (B) copies of the […***…]; and

(iv) that is conducted by Orexigen outside the Territory, for outside the
Territory, under an Orexigen IND for Contrave, […***…] shall provide to […***…]
copies of the […***…] for […***…].

(c) For clarity, information regarding adverse events and serious adverse events
shall be provided in accordance with the Pharmacovigilance Agreement. Each Party
understands and acknowledges that the other Party and its Affiliates, licensees,
sublicensees, and subcontractors, as applicable, may need to utilize and include
certain data and certain summary and general information regarding the
demonstration of efficacy and safety of the Product generated by such Party (for
example, adverse event reports and tabulated data summaries) as such Party
reasonably determines is required in its filings for regulatory approvals for
the Product inside or outside the Territory, as requested by regulatory
authorities inside or outside the Territory, and/or through communications with
regulatory authorities inside or outside the Territory. Orexigen shall have the
right to share any and all such data, information, and other regulatory
materials received from Takeda with Orexigen’s Affiliates, licensees,
sublicensees […***…] for use in […***…] a Product outside the Territory. Takeda
shall have the right to share any and all such data […***…] and other regulatory
materials received from Orexigen with Takeda’s Affiliates […***…] for use in
[…***…] a Product in or outside the Territory for the Territory and in […***…]
Regulatory Approval or Commercializing a Product in the Territory.

(d) All non-clinical, analytical, Manufacturing, and Clinical Trial data and
associated reports disclosed by one Party to the other under this Agreement
shall be deemed Confidential Information of the Disclosing Party; provided that,
except as otherwise set forth in this Agreement, the Receiving Party (or its
Affiliates, licensees or sublicensees) may use such data solely for the purpose
of developing, obtaining and […***…] regulatory approval, […***…] or
commercializing a Product in its respective territory, including pursuant to
Orexigen’s right to Co-Promote pursuant to Section 3.5. For the avoidance of
doubt, any and all […***…] relating to the […***…] shall be deemed […***…].

(e) Except as provided for in Section 2.2.9(c), […***…] shall not receive access
to […***…] (as contemplated in Section 2.2.9(a)). However, to the extent that
[…***…] receives […***…] (e.g., for purposes of its regulatory filings outside
the Territory, inadvertent disclosure, etc.), except as set forth in Section
10.3.4, […***…] agrees not to […***…]

 

- 24 -

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

FINAL VERSION

 

[…***…], without […***…].

3. COMMERCIALIZATION; CO-PROMOTION

3.1 Commercialization Activities. Takeda shall be responsible for
Commercializing Products in the Field in the Territory, subject to the terms and
conditions of this Agreement and in compliance in all material respects with
applicable Laws. Takeda shall be responsible for paying all Commercialization
Costs set forth in the Commercialization Plan approved by the JCC. Takeda shall
use Commercially Reasonable Efforts to Commercialize Products in the Field in
the Territory in accordance with the Commercialization Plan and the terms of
this Agreement, subject to Orexigen’s Commercialization of Contrave pursuant to
Section 3.5 and the terms of any Co-Promote Agreement. Upon exercise of its
right to Co-Promote pursuant to Section 3.5, Orexigen shall use Commercially
Reasonable Efforts to Commercialize Contrave in the Territory in accordance with
the Commercialization Plan, the terms of this Agreement and the Co-Promote
Agreement, and in compliance in all material respects with applicable Laws.
Except as otherwise provided for in Section 3.5 and any Co-Promote Agreement,
Takeda, its Affiliates or Sublicensees, as the case may be, shall have the sole
right and responsibility for all activities relating to Commercialization of all
Products in the Field in the Territory including: (a) booking all sales of
Products; (b) determining the price of all Products; (c) sale and distribution
of all Products as described in Section 3.3.5 below; (d) conducting all Product
marketing activities; (e) creating and approving all marketing programs and
promotional materials; and (f) conducting all Product medical affairs
activities, including field based medical liaison activities, investigator
initiated sponsored research, publications, medical education, health economics
outcomes research and medical information.

3.2 Additional Diligence Obligations. In addition to the general
responsibilities set forth in Section 3.1, Takeda shall have the following
specific diligence obligations:

3.2.1 Commencing on the First Commercial Sale of Contrave in the Initial
Indication in the Territory and ending on the […***…] (the “PDE Term”), Takeda
shall, in accordance with the Commercialization Plan and this Section 3.2.1,
provide at least the following Primary Detail Equivalents for such Product: (i)
during the first consecutive […***…] period following such First Commercial
Sale, […***…] Primary Detail Equivalents, of which at least […***…] shall be
[…***…] Details; (ii) during each of the following […***…] periods thereafter,
[…***…] Primary Detail Equivalents, of which at least […***…] shall be […***…]
Details (pro-rated for any partial […***…] period). Takeda shall provide its PDE
requirements with the goal of achieving the call plan described in Section
3.2.2, and in accordance with the following: (a) during each […***…], at least
[…***…] percent ([…***…]%) of its PDE requirement under the call plan; and (b)
during each […***…], at least […***…] percent ([…***…]%) of its PDE requirement
under the call plan. If Takeda fails to achieve […***…] percent ([…***…]%) of
its PDE

 

- 25 -

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

FINAL VERSION

 

requirement under the call plan in a […***…], it must exceed […***…] percent
([…***…]%) of its PDE requirement under such call plan in the following […***…]
by the number of PDEs that Takeda failed to achieve in the prior […***…] (i.e.,
that caused it to achieve less than […***…] percent ([…***…]%) of its PDE
requirement). If Takeda fails to achieve […***…] percent ([…***…]%) of its PDE
requirement under the call plan in any […***…], it must exceed […***…] percent
([…***…]%) of its PDE requirement under the call plan in the following […***…]
by the number of PDEs that Takeda failed to achieve under the call plan in the
prior […***…] (i.e., that caused it to achieve less then […***…] percent
([…***…]%) of its PDE requirement under the call plan). Any failure by Takeda to
correct a PDE shortfall (i.e., achieving less than […***…] percent ([…***…]%) of
its PDE requirement under the call plan in a […***…] or […***…] percent
([…***…]%) of its PDE requirement under the call plan in a […***…]) in the
timeframe specified above shall be a material breach of this Agreement;
provided, however, for the avoidance of doubt, (1) if Takeda achieves the PDE
requirements as set forth above, including through the correction of any
shortfall, it may not be held in material breach for failure to achieve […***…]
percent ([…***…]%) of the PDE requirements under the call plan and (2) details
that are not […***…] shall have no Primary Detail Equivalent value. Upon
expiration of the PDE Term, (x) the JCC shall consider the market conditions on
an annual basis and adjust the Commercialization Plan (including the PDE
requirements and the number of […***…] for the Product) to reflect the
then-current market conditions and (y) this Section 3.2.1 (other than, for
clarity, subsections (i) and (ii)) shall remain in full force and effect.

3.2.2 The Parties shall establish a Primary Detail Equivalent call plan for
Contrave, which shall be supported by a commensurate incentive plan that is
aligned with each Sales Representative’s individual call plan, and designed to
facilitate achievement of the overall PDE requirements, including as set forth
in Section 3.2.1. By way of example, and without limitation, if a Takeda Sales
Representative is directed to sell the Product and other Takeda product(s) that
are not the Product such that […***…] percent ([…***…]%) of such Takeda Sales
Representative’s PDEs are for the Product and […***…] percent ([…***…]%) of such
Takeda Sales Representative’s PDEs are for such other Takeda product(s), then in
any incentive plan for the Takeda Sales Representatives, such Product would
receive a […***…] percent ([…***…]%) incentive weighting and such other Takeda
product(s) would receive a […***…] percent ([…***…]%) incentive weighting. For
the avoidance of doubt, the incentive weighting for the Product is not required
to be greater than or equal to the incentive weighting for such other Takeda
product(s).

3.2.3 Commencing on the Original Effective Date and ending on the […***…],
Takeda shall, in accordance with the Commercialization Plan, incur at least
[…***…] Dollars ($[…***…]) in Commercialization Costs (excluding any costs and
expenses incurred in connection with Manufacturing activities) for pre-launch
activities associated with such Product. During the PDE Term, Takeda shall incur
the following Commercialization Costs (excluding any costs and expenses incurred
in connection with Manufacturing activities) for promotion of such Product:
(i) during the first […***…] during the PDE Term, […***…] Dollars ($[…***…]);
and (ii) during each of the following […***…] during the PDE Term, […***…]
Dollars ($[…***…]) (pro-rated for any partial […***…]). Thereafter, the JCC
shall consider the market conditions on an annual basis and adjust

 

- 26 -

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

FINAL VERSION

 

the amount of Commercialization Costs to be incurred by Takeda for such Product
to reflect the then-current market conditions.

3.2.4 Not more than […***…] per Calendar Year, and no more than […***…] for each
Calendar Year, Orexigen shall have the right to conduct an inspection and audit
of information relating to PDEs, incentive plans, and promotional budget
expenditures directly relating to the Product, to confirm Takeda’s compliance
with Sections 3.2.1 and 3.2.3. Such inspection and audit shall be conducted at
Orexigen’s expense during normal business hours, and upon not less than […***…]
([…***…]) days prior written notice to Takeda.

3.3 Commercialization.

3.3.1 Commercialization Plan. The initial Commercialization Plan for Contrave in
the Territory shall be agreed upon by the Parties within […***…] ([…***…]) days
after the Original Effective Date. To the extent that the Commercialization Plan
includes other Products in the Territory, such Commercialization Plan shall also
be mutually agreed upon by the Parties. Notwithstanding the exercise by Orexigen
of its right to Co-Promote the Product, all Products in the Field in the
Territory shall be sold, and all sales shall be booked, by Takeda, its
Affiliates and Sublicensees, as the case may be, and Takeda shall pay milestones
and royalties to Orexigen in accordance with Article 7 with respect thereto.

3.3.2 Updates to Commercialization Plan. The Commercialization Plan for the
Territory shall be updated or amended by the JCC on an annual basis, or more
frequently as necessary, including promptly after Orexigen exercises its right
to Co-Promote pursuant to Section 3.5. Updates and amendments to the
Commercialization Plan shall be subject to the approval of the JSC pursuant to
Section 5.1.2(c), and, if Orexigen exercises its right to Co-Promote, made in
accordance with the last sentence in Sections 3.2.1 and 3.2.3. Each Calendar
Year, the JCC will prepare an update to the Commercialization Plan, and submit
it in advance to the JSC in order to obtain approval from the JSC no later than
[…***…].

3.3.3 JCC Commercialization Information and Reports. Each Party shall provide
the other Party, upon request, with copies of all material Product-specific
information relating to Commercialization of the Product generated by such
Party, or on behalf of such Party by any Third Party, including market research
and other information generated in connection with the conduct of promotional
efficiency and other Commercialization activities; provided, however, for the
avoidance of doubt, neither Party shall be obligated to disclose information
that relates to products outside the scope of this Collaboration. Each Party
will provide the JCC with written Commercialization reports or presentations at
JCC meetings. Each such report or presentation shall include the
Commercialization activities accomplished by or on behalf of such Party since
the previous JCC meeting, and other relevant matters, including a summary of
Primary Detail Equivalents broken out on a monthly basis, a copy of all
then-current incentive plans relating to the Products, and the status of
Commercialization activities as compared to the timelines in the then-existing
Commercialization Plan. The Commercialization reports shall also include the
reports set forth on Exhibit 3.3.3, and summaries of the costs incurred by each
Party in the performance of its Commercialization activities prior to the date
of such report. The JCC shall provide to the JSC copies of the information
provided under this Section 3.3.3. Takeda shall provide any reports referred to
in this Section 3.3.3 and received

 

- 27 -

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

FINAL VERSION

 

from Third Parties to Orexigen promptly, but in no event later than […***…]
([…***…]) days after receipt of such report from such Third Party.

3.3.4 Commercialization Costs.

(a) Except as otherwise expressly provided in this Agreement, Takeda shall bear
all Commercialization Costs incurred by either Party in accordance with the
Commercialization activities, and corresponding budgeted costs, set forth in the
Commercialization Plan approved by the JSC.

(b) Takeda shall reimburse Orexigen, on a quarterly basis in arrears, for all
PDE Costs incurred by Orexigen during the prior Calendar Quarter. After the end
of each Calendar Quarter, Orexigen shall submit to Takeda an itemized invoice
for PDE Costs incurred by Orexigen in accordance with the activities assigned to
it in the Commercialization Plan during such Calendar Quarter, and Takeda shall
pay to Orexigen an amount equal to such PDE Costs within […***…] ([…***…]) days
after delivery of such invoice. Notwithstanding the foregoing, if Takeda
disputes all or any portion of the PDE Costs submitted to it by Orexigen, Takeda
shall not be required to pay such disputed PDE Costs within […***…] ([…***…])
days after delivery of the invoice to Takeda, and the Parties shall use good
faith efforts to discuss and resolve such disputed amount.

3.3.5 Sales and Distribution. Notwithstanding the exercise by Orexigen of its
right to Co-Promote Contrave pursuant to Section 3.5, Takeda shall have the sole
right and responsibility for handling all sales and distribution activities,
including returns, order processing, invoicing and collection, distribution
(including importing, exporting, transporting, customs clearance, warehousing,
invoicing, handling and delivering Products to customers), and inventory and
receivables for the Products in the Field in the Territory. Orexigen shall not
accept orders for the purchase of a Product from Third Parties, or make sales of
Product to Third Parties in the Field in the Territory for its own account or
for Takeda’s account. If Orexigen receives any order for a Product in the Field
in the Territory, it shall refer such orders to Takeda for acceptance or
rejection. Takeda shall have the sole right and responsibility for:
(i) negotiating, establishing or modifying the terms and conditions regarding
the sale of the Product in the Field in the Territory, including any terms and
conditions relating to or affecting (a) the price at which the Product shall be
sold, (b) discounts available to any Third Party payers (including managed care
providers, indemnity plans, unions, self insured entities, and government payer,
insurance or contracting programs such as Medicare, Medicaid, or the U.S.
Department of Veterans Affairs), (c) discounts attributable to payments on
receivables, (d) distribution of the Product, and (e) credits, price
adjustments, or other discounts and allowances to be granted or refused; and
(ii) all activities relating to government price reporting with respect to any
Product in the Field in the Territory.

3.3.6 Bundling. Takeda hereby agrees that it will not, nor, to the extent
permitted under applicable Laws, shall it allow its Affiliates or Sublicensees
to, provide a discount on Products as part of a multiple product offering with
any other products or services that: (i) […***…]; or (ii) […***…].

 

- 28 -

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

FINAL VERSION

 

3.4 Regulatory Responsibilities.

3.4.1 Prior to receipt of Regulatory Approval in the Territory for the Initial
Indication for Contrave: (a) Orexigen shall prepare, file, maintain, and own all
Regulatory Filings, including the IND and the NDA for Contrave in the Territory,
and related submissions with respect to Contrave in the Territory; and
(b) Orexigen shall promptly notify Takeda of all material Regulatory Filings
with respect to Contrave that it proposes to submit to Regulatory Authorities,
or that it receives from Regulatory Authorities, in the Territory (including all
substantive correspondence with such Regulatory Authorities, responses from such
Regulatory Authorities, requests for information from such Regulatory
Authorities, briefing documents and other materials relating to interactions
with such Regulatory Authorities, and summaries of outputs resulting from
substantive correspondence/conversations or meetings with such Regulatory
Authorities), and shall promptly provide Takeda with a copy (which may be wholly
or partly in electronic form) of such Regulatory Filings for review by Takeda.
Takeda shall provide any comments promptly, but in no event later than […***…]
([…***…]) Business Days after receiving such Regulatory Filings, Orexigen shall
reasonably consider and give due consideration to any such comments provided by
Takeda, and, as necessary, it shall discuss such comments with Takeda, and each
Party shall use good faith efforts to mutually agree on the content of any
communications that relate to or contain commitments made or to be made by
Orexigen to Regulatory Authorities for the purpose of obtaining Regulatory
Approvals; provided, however, (i) Orexigen shall retain the right to make any
final decisions with respect to the content of any such communications, which
shall be compliant with the Development Plan, this Agreement and applicable Law,
and (ii) in the event any interaction with a Regulatory Authority is
time-sensitive, Orexigen shall have the right to communicate with such
Regulatory Authority within the time frame requested by such Regulatory
Authority. Orexigen shall provide Takeda with reasonable advance notice of any
scheduled meeting with any Regulatory Authority relating to the Product or any
Regulatory Approval in the Territory, and Takeda shall have the right to have up
to […***…] ([…***…]) individuals attend and participate in any such meeting;
provided, however, Orexigen will retain the lead role and responsibility in any
such meetings.

3.4.2 The Parties acknowledge and agree that as of the Amended and Restated
Effective Date, Orexigen has transferred all Regulatory Filings relating to
Contrave in the Territory, including the IND and the NDA for Contrave in the
Territory, into the name of Takeda and provided Takeda with a copy of all such
Regulatory Filings. Takeda is responsible for (a): preparing, filing,
maintaining and owning all Regulatory Filings and related submissions, including
the IND and the NDA for Contrave in the Territory, with respect to Products in
all Indications in the Territory, and (b) leading discussions and meetings with
all Regulatory Authorities regarding Products in all Indications in the
Territory; provided, however, […***…] ([…***…]) representatives of Orexigen
shall be entitled to participate in any such discussions and meetings with
Regulatory Authorities, and, if an appropriate Orexigen representative(s) is
requested by Takeda to attend a discussion or meeting with a Regulatory
Authority regarding the Products in the Indications in the Territory, Orexigen
will use Commercially Reasonable Efforts to arrange for such individual(s) to
participate in such discussions or meetings.

3.4.3 Upon request, Takeda will provide the JSC with copies of all Regulatory
Filings and related material correspondence submitted to Regulatory Authorities
or received from Regulatory Authorities with respect to Products in all
Indications in the Territory.

 

- 29 -

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

FINAL VERSION

 

Takeda will promptly furnish, but in no event later than […***…] ([…***…])
Business Days after receipt or generation, Orexigen with copies of all such
Regulatory Filings (including all substantive correspondence with such
Regulatory Authorities, responses from such Regulatory Authorities, requests for
information from such Regulatory Authorities, briefing documents and other
materials relating to interactions with such Regulatory Authorities, and
summaries of outputs resulting from substantive correspondence/conversations or
meetings with such Regulatory Authorities). In addition, prior to making a
Regulatory Filing relating to Contrave or responding to any such Regulatory
Authority correspondence or interactions, except to the extent impracticable
with respect to expedited safety reports, timelines imposed by Regulatory
Authorities, Takeda SOPs and other similar time-sensitive issues, Takeda shall
provide to the JDC and JSC a complete draft copy for its review and comment.
Takeda shall give due consideration to any comments of the JDC and JSC with
respect thereto.

3.4.4 Notwithstanding any transfer of Regulatory Filings or ownership thereof to
Takeda, Orexigen shall have, on behalf of itself, its Affiliates, and licensees
and sublicensees, the right to access and reference data and information
contained in any Regulatory Filings to the extent useful or necessary in
connection with (a) Product regulatory filings outside the Territory and/or
(b) any Clinical Trial of a Product conducted in the Territory by Orexigen or
its Affiliates, licensees, and sublicensees for the Territory or for outside the
Territory. Orexigen hereby grants to Takeda, its Affiliates and Sublicensees,
the right to access and reference data and information contained in any of
Orexigen’s, or its Affiliates’, licensees’ and sublicensees’ Product regulatory
filings outside the Territory to the extent useful or necessary in connection
with Regulatory Filings in or for the Territory. Each Party agrees to provide
letters of authorization and take any other actions as reasonably necessary for
the other Party to exercise its right to access and reference data and
information as permitted under this Section 3.4.4.

3.4.5 If a Regulatory Authority desires to conduct an inspection or audit of, or
sends a communication to, Takeda or Orexigen or any Third Party engaged by
either Party to perform activities under the Development Plan or
Commercialization Plan with regard to any Product or this Agreement, Takeda and
Orexigen each agrees to cooperate with the Regulatory Authority and the other
Party during such inspection or audit, including by allowing, to the extent
practicable, a representative of the other Party to be present during the
applicable portions of such inspection or audit. Following receipt of the
inspection or audit observations of the Regulatory Authority (a copy of which
the responsible Party will immediately provide to the other Party), the
responsible Party will prepare the response to any observation that concerned
this Agreement. The other Party agrees to fully cooperate when it prepares such
a response, including by providing to the responsible Party, within […***…]
([…***…]) Business Days after its request, such information and documentation in
the Party’s possession as may be necessary for the responsible Party to prepare
such response. Before submitting the response to the Regulatory Authority, the
responsible Party agrees to give the other Party a reasonable opportunity to
comment on it.

3.4.6 Each Party (and its Third Party subcontractors) shall notify the other
Party within […***…] ([…***…]) Business Day of receipt of notification from a
Regulatory Authority of the intention of such Regulatory Authority to audit or
inspect a Party’s facilities with respect to any Product, including facilities
being used for Manufacture of any Product. Each Party (and its Third Party
subcontractors) shall also provide the other Party with copies of any written

 

- 30 -

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

FINAL VERSION

 

communications received from Regulatory Authorities with respect to such
facilities within […***…] ([…***…]) Business Days of receipt. Such Party shall
provide the other Party with an opportunity to review and provide input on any
proposed response by such Party (or Third Party subcontractor) to such
communications.

3.5 Orexigen’s Co-Promote Activities.

3.5.1 Initial Co-Promote Period. During the period commencing on the date of the
First Commercial Sale of Contrave in the Territory for the Initial Indication
and ending on the […***…] ([…***…]) anniversary of such date (the “Initial
Co-Promote Period”), Orexigen shall have the right to participate in the
Commercialization of the Product by promoting or detailing the Product in the
Field in the Territory (“Co-Promote”), Orexigen shall have the right to provide
up to […***…] Primary Detail Equivalents per year, of which at least […***…]
percent ([…***…]%) shall be […***…] Details during the […***…], and […***…]
percent ([…***…]%) shall be […***…] Details in each […***…] thereafter. Orexigen
shall perform its Primary Detail Equivalents only through Orexigen’s Sales
Representatives (in accordance with Section 3.5.5) and exclusively targeting
obstetricians and gynecologists or other targets approved by the JCC. Takeda
shall be required to pay Orexigen the PDE Costs incurred by Orexigen in
connection with such Co-Promote activities under this Section 3.5.1 as provided
in Section 3.3.4(b). Orexigen shall provide Takeda with prior written notice of
its intention to Co-Promote in accordance with this Section 3.5.1. Orexigen may
provide written notice to Takeda of its intention to Co-Promote under this
Section 3.5.1 […***…], in which case Orexigen shall be permitted to begin its
Co-Promote activities on […***…]. For example, if Orexigen provides written
notice to Takeda of its intention to Co-Promote under this Section 3.5.1 at any
time from […***…], then Orexigen may begin its Co-Promote activities on […***…].

3.5.2 Secondary Co-Promote Period. Except as otherwise provided in Section
3.5.4, during the period commencing on the […***…] ([…***…]) anniversary of the
date of the First Commercial Sale of Contrave in the Territory for the Initial
Indication and ending upon […***…] (the “Secondary Co-Promote Period”), Orexigen
shall have the exclusive option (the “Co-Promote Option”) to Co-Promote such
Product in the Field in the Territory. Orexigen may exercise the Co-Promote
Option by providing written notice to Takeda at any time prior to […***…] during
[…***…] during the Secondary Co-Promote Period, in which case Orexigen shall be
permitted to: (a) begin its Co-Promote activities on […***…] of the following
[…***…], (b) perform up to […***…] Primary Detail Equivalents in the […***…]
([…***…]) month period following the start of its Co-Promote activities (i.e.,
[…***…] through […***…] after exercise of the Co-Promote Option), (c) perform up
to […***…] Primary Detail Equivalents in each […***…] ([…***…]) month period
thereafter (i.e., after the […***…] ([…***…]) month period referenced in Section
3.5.2(b)), and (d) only through Orexigen’s Sales Representatives […***…]. Upon
exercise of the Co-Promote Option by Orexigen, and during the Secondary
Co-Promote Period, […***…]. In addition, notwithstanding anything to the
contrary contained in this Agreement: (1) Takeda

 

- 31 -

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

FINAL VERSION

 

[…***…], and (2) Orexigen shall compensate Takeda for all reasonable Third Party
costs and internal personnel costs not to exceed […***…] Dollars ($[…***…]),
incurred by Takeda in support of Orexigen’s implementation activities necessary
to begin Co-Promoting the Product.

3.5.3 Promptly after exercise of the earlier of Orexigen’s exercise of its right
under Section 3.5.1 or the Co-Promote Option under Section 3.5.2, the JCC will
amend the Commercialization Plan to address the transition of promotional
activities from Takeda to both of the Parties. In addition, promptly thereafter
(and in all events prior to the commencement of any Co-Promotion activities by
Orexigen), the Parties shall diligently and in good faith negotiate and enter
into a Co-Promote Agreement for the Commercialization of the Product in the
Field in the Territory by Orexigen and Takeda, on mutually agreeable terms,
including the terms set forth in Article 3 and Exhibit 3.5.3; provided, however,
if the Parties fail to enter into a Co-Promote Agreement within the timeframe
contemplated in this Section 3.5.3, the terms set forth in Article 3 and Exhibit
3.5.3 shall govern the Commercialization of the Product as if the Parties had
entered into a Co-Promote Agreement.

3.5.4 Notwithstanding anything to the contrary contained in Section 3.5.1 or
Section 3.5.2, Orexigen’s Successor shall have the right to Co-Promote the
Product in accordance with this Agreement and the Co-Promote Agreement by
providing Takeda with […***…] ([…***…]) months prior written notice if such
right is exercised during the Initial Co-Promote Period, or […***…] ([…***…])
months prior written notice if such right is exercised during the Secondary
Co-Promote Period. If Orexigen’s Successor exercises such Co-Promote right, (a)
Orexigen’s Successor shall have the right to perform up to […***…] Primary
Detail Equivalents during each […***…] thereafter in accordance with a JCC
approved Commercialization Plan, […***…], (b) during the Initial Co-Promote
Period, if Orexigen’s Successor elects to conduct more than […***…] Primary
Detail Equivalents, […***…], (d) Orexigen shall compensate Takeda for all
reasonable Third Party costs and internal personnel costs not to exceed […***…]
Dollars ($[…***…]), incurred by Takeda in support of the implementation
activities necessary for Orexigen’s Successor to begin Co-Promoting the Product,
(e) Orexigen’s Successor shall be subject to the terms and conditions of the
Co-Promote Agreement, provided that relevant terms

 

- 32 -

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

FINAL VERSION

 

and conditions of the Co-Promote Agreement shall be modified through mutual
agreement to address the rights and obligations of Takeda and Orexigen’s
Successor contained in this Section 3.5.4, and (f) the […***…] for Orexigen’s
Successor shall be discussed at the JCC; provided, further, the JCC shall take
into account the following when selecting […***…].

3.5.5 With respect to Orexigen’s Co-Promote activities, Orexigen’s Sales
Representatives shall be either employees of Orexigen or employees or
contractors of a contract sales organization that (i) […***…], and (ii) […***…].

3.6 Pharmacovigilance. Orexigen and Takeda entered into a pharmacovigilance
agreement effective as of September 10, 2014 (as may be amended by the Parties
in accordance with its terms, the “Pharmacovigilance Agreement”) concerning all
matters relating to management and exchange of safety information on terms no
less stringent than those required by ICH guidelines. Takeda shall be
responsible, at its own expense, for the establishment and maintenance of the
global safety database for Products in all Indications in the Territory. Each
Party shall cooperate (at its sole cost and expense), and shall cause its
Affiliates, licensees, and sublicensees to cooperate, in implementing a
pharmacovigilance mutual alert process with respect to the Products and to
comply with all applicable Laws. Generally, (a) prior to transfer of the
Regulatory Filings as set forth in Section 3.4.2, Orexigen shall be responsible
for submitting all required IND safety reports contemplated by 21 C.F.R. 312.32,
and post-marketing reports of adverse drug experiences contemplated by 21 C.F.R.
314.80, or the foreign equivalent in the Territory, relating to Products to the
appropriate Regulatory Authorities in the Territory, in accordance with
applicable Laws; (b) following transfer of the Regulatory Filings as set forth
in Section 3.4.2, and with respect to any other Regulatory Filings, Takeda shall
be responsible for reporting all adverse drug reaction experiences required to
be reported to the appropriate Regulatory Authorities in the Territory in which
such Product is being Developed or Commercialized, in accordance with Laws; and
(c) Orexigen, its Affiliates or licensees or sublicensees shall be responsible
for submitting all regulatory filings, including any post-marketing reports of
adverse drug experiences, relating to Products and required to be reported to
the appropriate regulatory authorities outside of the Territory, in accordance
with the Laws of the relevant countries. Orexigen shall have the right to share
any and all information received from Takeda under this Section 3.6, or the
Pharmacovigilance Agreement, with Orexigen’s Affiliates and licensees and
sublicensees outside the Territory. Takeda shall have the right to share any and
all information received from Orexigen under this Section 3.6 or the
Pharmacovigilance Agreement with Takeda’s Affiliates and Sublicensees in the
Territory. The JSC shall review from time to time Takeda’s and Orexigen’s
pharmacovigilance policies and procedures. The Pharmacovigilance Agreement
identifies the responsibilities of each Party regarding the information to be
exchanged and the timeframes for such exchange, regulatory reporting, literature
review, risk management, and labeling.

 

- 33 -

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

FINAL VERSION

 

3.7 Recalls and Product Safety. The Parties shall exchange their internal
standard operating procedures (“SOPs”) for conducting product recalls reasonably
in advance of the First Commercial Sale of any Product in the Territory, and
shall discuss and resolve any conflicts between such SOPs and issues relating
thereto promptly after such exchange. If either Party becomes aware of
information relating to any Product that indicates that a unit or batch of
Product may not conform to the specifications therefor, or that potential
adulteration, misbranding, or other issues have arisen that relate to the safety
or efficacy of Products, it shall promptly so notify the other Party. The JSC
shall meet to discuss such circumstances and to consider appropriate courses of
action, which shall be consistent with the internal SOP of the Party having the
right to control such recall pursuant to this Section 3.7. Takeda shall have the
right and responsibility to control any product recall, field correction, or
withdrawal of any Product in the Territory that is required by Regulatory
Authorities in the Territory, and the allocation of expenses incurred in
connection with such recall between the Parties is set forth in the
Manufacturing Services Agreement. In addition, Takeda shall have the right, at
its discretion, to conduct any product recall, field correction, or withdrawal
of any Product in the Territory that is not so required by such Regulatory
Authorities but that Takeda deems to be appropriate, with the allocation of
expenses incurred in connection with such recall between the Parties set forth
in the Manufacturing Services Agreement. As between the Parties, Orexigen shall
have the right, at its expense, to control all recalls, field corrections, and
withdrawals of any Product outside the Territory; provided, however, Orexigen
shall provide Takeda with at least […***…] ([…***…]) days prior written notice
before taking any such action. Takeda shall maintain complete and accurate
records of any recall in the Territory for such periods as may be required by
Laws, but in no event for less than […***…] ([…***…]) years.

3.8 Trademarks.

3.8.1 Product Trademarks. All packaging, promotional materials, package inserts,
and labeling for each Product shall bear one or more Trademark(s) that pertain
specifically to such Product, including the Trademark(s) set forth on Exhibit
3.8.1 (“Product Trademark”). Orexigen shall be the sole and exclusive owner of
all Product Trademarks. Orexigen shall […***…] be responsible for filing,
prosecuting, and maintaining, including searching and policing, any and all
Product Trademarks, and conducting litigation with respect thereto. Except as
expressly permitted by Orexigen, Takeda shall make no use of the Product
Trademarks or any Trademark that includes any of the Product Trademarks, or is
confusingly similar thereto, on or in connection with any product or service
anywhere in the world. Without limiting the generality of the foregoing, Takeda
shall not use any Trademark that is the same as, or similar to (so as to cause
confusion in consumers), the Product Trademarks. The foregoing shall not be
construed as restricting Takeda from making factual references to the Product
Trademarks in its Regulatory Filings under this Agreement or to satisfy its
legal and regulatory obligations. If the Product Trademarks in existence as of
the Original Effective Date are not eligible for trademark protection or for use
in connection with the Products in the Territory, then the JCC shall identify
alternative trademarks owned, registered or to be registered by Orexigen and to
be used for the Products in the Territory, for Takeda final selection from among
such trademarks identified by the JCC, and the Parties shall amend this
Agreement to identify such marks and include them as Product Trademarks for the
Territory.

 

- 34 -

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

FINAL VERSION

 

3.8.2 Orexigen Trademarks. All packaging, promotional materials, package
inserts, and labeling for each Product shall bear one or more house Trademark(s)
chosen and owned by Orexigen, including the Orexigen name and Orexigen Logo
(“Orexigen Trademark”). Orexigen shall be the sole and exclusive owner of all
Orexigen Trademarks. Orexigen shall bear the full costs and expense of and be
responsible for filing, prosecuting, and maintaining, including searching and
policing, any and all Orexigen Trademarks, and conducting litigation with
respect thereto. Except as expressly permitted by Orexigen, Takeda shall make no
use of the Orexigen Trademarks or any Trademark that includes any of the
Orexigen Trademarks, or is confusingly similar thereto, or any of Orexigen’s or
its Affiliates’ Trademarks, on or in connection with any product or service
anywhere in the world. Without limiting the generality of the foregoing, Takeda
shall not use any Trademark that is the same as, or similar to (so as to cause
confusion in consumers), the Orexigen Trademarks. The foregoing shall not be
construed as restricting Takeda from making factual references to the Orexigen
Trademarks in its Regulatory Filings under this Agreement or to satisfy its
legal and regulatory obligations.

3.8.3 Takeda Trademarks. All packaging, promotional materials, package inserts,
and labeling for each Product shall bear one or more house Trademark(s) chosen
and owned by Takeda, including the Takeda name and logo (“Takeda Trademark”).
Takeda shall be the sole and exclusive owner of all Takeda Trademarks. Takeda
shall bear the full costs and expense of and be responsible for filing,
prosecuting, and maintaining, including searching and policing, any and all
Takeda Trademarks, and conducting litigation with respect thereto. Except as
expressly permitted by Takeda, Orexigen shall make no use of the Takeda
Trademarks or any Trademark that includes any of the Takeda Trademarks, or is
confusingly similar thereto, or any of Takeda’s or its Affiliates’ Trademarks,
on or in connection with any product or service anywhere in the world. Without
limiting the generality of the foregoing, Orexigen shall not use any Trademark
that is the same as, or similar to (so as to cause confusion in consumers), the
Takeda Trademarks. The foregoing shall not be construed as restricting Orexigen
from making factual references to the Takeda Trademarks in its Regulatory
Filings under this Agreement or to satisfy its legal and regulatory obligations.

3.8.4 Quality Control. Each Party agrees to (a) conduct its business in a manner
that will not damage the reputation or integrity of the Trademarks of the other
Party, (b) conduct its business in a manner that will not damage in any way the
goodwill associated with the Trademarks of the other Party, (c) use the
Trademarks of the other Party in a manner that will not cause a negative impact
upon the good name of such other Party, (d) conduct its business in compliance
with all applicable trademark Laws and (e) to use the other Party’s Trademarks
only in accordance with this Agreement.

3.8.5 Product Marking. To the extent permitted under Laws, the packaging,
promotional materials, package inserts, and labeling for Products will bear both
the Takeda name and Takeda logo and the Orexigen name and Orexigen Logo, and
such names and logos will be presented in a manner agreed to by the Parties.
Orexigen will be responsible for registering and policing the Orexigen Logo in
order to enable Takeda to appropriately mark any packaging with the Orexigen
Logo, to the extent permitted or required by Laws. Except as set forth in this
Section 3.8 and Sections 6.1.2 and 6.1.3, no right or license, express or
implied, is granted to Takeda to use any trademark, trade name, trade dress, or
service mark Controlled by Orexigen or any of its Affiliates. No right or
license, express or implied, is granted to Orexigen

 

- 35 -

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

FINAL VERSION

 

under this Agreement to use any trademark, trade name, trade dress or service
mark Controlled by Takeda or any of its Affiliates.

4. PRODUCT SUPPLY

4.1 Manufacturing Services Agreement; Quality Agreement. The Parties entered
into a manufacturing services agreement, dated as of September 2, 2014 (as may
be amended by the Parties in accordance with its terms, the “Manufacturing
Services Agreement”), which governs the Manufacture and supply of the Product.
The Parties entered into a quality agreement, dated as of September 24, 2014 (as
may be amended by the Parties in accordance with its terms, the “Quality
Agreement”), which governs quality roles and responsibilities with respect to
the Manufacture and supply of the Product under the Manufacturing Services
Agreement.

4.2 Takeda’s Option to Manufacture. […***…], Takeda may elect, subject to the
provisions of Section 14.1, to assume the exclusive right and responsibility to
Manufacture or have Manufactured the Product for the Territory by notifying the
JSC and the JMC. Within […***…] ([…***…]) days after such notice, the JMC shall
begin working on a transition plan for transferring responsibility for
Manufacturing activities for Products in the Territory from Orexigen to Takeda
within a commercially reasonable timeframe (the “Manufacturing Responsibility
Transition Plan”). The Manufacturing Responsibility Transition Plan will be
subject to approval by the JSC. Prior to such transfer, Orexigen shall have the
sole right to make and have made Products in accordance with the Manufacturing
Services Agreement for Takeda’s or Orexigen’s use in Development or
Commercialization activities under this Agreement. The Manufacturing
Responsibility Transition Plan will reasonably take into account Orexigen’s
obligation, if any, to supply the Product for use outside the Territory for
purposes unrelated to the Parties’ activities under this Agreement. Each Party
shall use Commercially Reasonable Efforts to perform its responsibilities under
the Manufacturing Responsibility Transition Plan. Upon transfer of Manufacturing
to Takeda in accordance with the Manufacturing Responsibility Transition Plan,
as between the Parties, Takeda shall assume the sole and exclusive right and
responsibility to Manufacture Products for the Territory, itself or through
Third Party Manufacturers. Orexigen acknowledges and agrees that following
transfer of Manufacture of the Product to Takeda, Takeda will have no obligation
to supply the Product for any use outside the Territory that is unrelated to the
Parties’ activities under this Agreement. Upon Takeda’s assumption of such
responsibility, the Manufacturing Services Agreement shall automatically
terminate. Orexigen shall continue to have the sole right and obligation to
supply Takeda its requirements of Products in the Territory until any such
transfer of Manufacturing is successfully achieved in accordance with the
Manufacturing Responsibility Transition Plan and approved by appropriate
Regulatory Authorities.

4.3 [Intentionally Omitted.]

4.4 Commercial Packaging. Takeda, itself and/or through one or more of its
Affiliates and/or through one or more subcontractors, shall have the sole right
and responsibility

 

- 36 -

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

FINAL VERSION

 

to perform Commercial Packaging in the Territory; provided, however, that
Orexigen shall have the sole right and responsibility to perform stability
testing on Products; provided further, however, that the Parties may mutually
agree, at any time during the Term, to transfer to Takeda the right and
responsibility to perform stability testing for Product in connection with
Commercial Packaging. At the time of such transfer, stability testing for
Product in final packaged form will be included in the term “Commercial
Packaging.” Prior to any such transfer, Takeda shall provide Orexigen, at
Orexigen’s request, with sufficient amounts of Product after Takeda has
completed Commercial Packaging for such Product to enable Orexigen to complete
stability testing for purposes of compliance with any and all regulatory
requirements in the Territory. For the avoidance of doubt, prior to the transfer
of the right and responsibility for Manufacturing activities pursuant to
Section 4.2 for Product in the Territory from Orexigen to Takeda, Orexigen shall
retain the sole right and responsibility for all Manufacturing activities other
than Commercial Packaging, including manufacturing Product in finished form for
Development. Section 3.4.6 shall apply with respect to Takeda’s, its
Affiliates’, and/or subcontractors’ performance of any Commercial Packaging
activities.

5. GOVERNANCE

5.1 Joint Steering Committee.

5.1.1 Formation and Purpose. Within […***…] ([…***…]) days after the Original
Effective Date, the Parties shall establish a joint steering committee (the
“JSC”) to oversee the Collaboration and to make certain decisions regarding the
Development and Commercialization activities of the Parties during the Term as
set forth in this Section 5.1. The JSC shall have review and oversight
responsibilities for all Development and Commercialization activities. The JSC
shall also provide a forum for sharing advice, progress and results relating to
such activities and shall attempt to facilitate the resolution of any Disputes
between the Parties, as described in Section 5.7. The JSC shall have access to
all Development Plans and Commercialization Plans and related budgets and shall
be briefed by the Parties regarding the content, execution and results achieved
by the respective Parties thereunder. Each Party, through its representatives on
the JSC, shall be permitted to provide advice and commentary with respect to the
Development Plans and Commercialization Plans and related budgets. As
applicable, each Party shall take such advice and commentary into good faith
consideration.

5.1.2 Specific Responsibilities of the JSC. In addition to its general
responsibilities set forth in Section 5.1.1, the JSC shall, in particular, have
responsibility to:

(a) oversee and coordinate the Development activities;

(b) review, provide comments relating to, and approve each Development Plan, and
any modifications thereof or amendments thereto, to ensure that the Development
Plan is designed to meet the Development diligence objectives set forth in
Section 2.1;

(c) review, provide comments relating to, and approve each Commercialization
Plan, and any modifications thereof or amendments thereto, to ensure that the

 

- 37 -

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

FINAL VERSION

 

Commercialization Plan is designed to meet the Commercialization diligence
objectives set forth in Sections 3.1 and 3.2;

(d) review and provide comments to the pricing strategy for each Product (as
included in the Commercialization Plan), subject to the provisions of
Section 3.1 and applicable Law;

(e) review the overall progress under the Product Plans;

(f) provide a forum for the Parties to discuss and attempt to resolve Disputes;
and

(g) such other responsibilities as the Parties may allocate to the JSC.

5.1.3 Membership of the JSC. The JSC shall consist of […***…] ([…***…])
representatives having appropriate decision-making authority (e.g., at least the
Vice President position) designated by each of Orexigen and Takeda, and shall
operate by consensus with each Party having one (1) vote. Additional
representatives having relevant expertise may from time to time be invited to
attend JSC meetings; provided, however, any such representatives who are not
employees of a Party or its Affiliates shall be subject to such representative’s
written agreement to comply with the requirements of this Agreement.

5.1.4 Meetings of the JSC. The JSC shall meet at least […***…] ([…***…]) times
annually during the Term or at such other frequency as mutually agreed by the
Parties. The JSC shall meet on such dates and at such times as agreed to by
Orexigen and Takeda, with all scheduled in-person meetings to alternate between
an Orexigen site and a Takeda site as designated by the respective Party prior
to such meeting, or at other locations as determined by the JSC. Meetings may be
held by audio or video conference with the consent of each Party. Each Party
shall be responsible for its own expenses for participating in each JSC.
Meetings of the JSC shall be effective only if a majority of the representatives
of each Party are present or participating.

5.2 Joint Development Committee.

5.2.1 Formation and Purpose. Within […***…] ([…***…]) days after the Original
Effective Date, the Parties shall establish a joint development committee (the
“JDC”), which shall perform the primary function of designing, implementing,
monitoring, reviewing and discussing the Development Plan and Development budget
for the Product, including progress and performance thereunder, and for
proposing updates or amendments to the Development Plan and Development budget
for approval by the JSC.

5.2.2 Specific Responsibilities of the JDC. In addition to its general
responsibilities set forth in Section 5.2.1, the JDC shall, in particular, have
responsibility for:

(a) facilitating cooperation and coordination between the Parties regarding
Development matters;

 

- 38 -

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

FINAL VERSION

 

(b) preparing and proposing, for JSC approval, amendments to the then-current
Development Plan and the corresponding Development budget and proposing such
Development Plan and Development budget for approval by the JSC. Any amended
Development Plan shall cover the next Calendar Year (and additional periods as
reasonably determined by the Parties) and shall contain a corresponding
Development budget;

(c) monitoring, reviewing, coordinating, and discussing the overall progress of
Development under this Agreement;

(d) facilitating the flow of information with respect to Development activities
being conducted for Products in or for the Territory, including through the
review of data, reports, or other information submitted by either Party with
respect to Development activities conducted by or on behalf of such Party;

(e) assigning lead parties for specific tasks or activities identified in the
Development Plan;

(f) reviewing, discussing and proposing appropriate Third Party subcontractors
to engage for the purpose of supporting the Development activities to be carried
out by each of the Parties;

(g) coordinating communications by the Parties with the Regulatory Authorities
with respect to Products in accordance with this Agreement; and

(h) reviewing, coordinating, discussing and proposing the overall strategy for
Regulatory Filings for approval by the JSC, except to the extent impracticable
with respect to expedited safety reports.

5.2.3 Membership of the JDC. The JDC shall consist of […***…] ([…***…])
representatives designated by each of Orexigen and Takeda and shall operate by
consensus with each Party having one (1) vote. Additional representatives having
relevant expertise may from time to time be invited to attend JDC meetings;
provided, however, any such representatives who are not employees of a Party or
its Affiliates shall be subject to such representative’s written agreement to
comply with the requirements of this Agreement.

5.2.4 Meetings of the JDC. The JDC shall meet at least […***…] ([…***…]) times
annually during the Term or at such other frequency as mutually agreed by the
Parties. The JDC shall meet on such dates and at such times as agreed to by
Orexigen and Takeda, with all scheduled in-person meetings to alternate between
an Orexigen site and a Takeda site as designated by the respective Party prior
to such meeting, or at other locations as determined by the JDC. Meetings may be
held by audio or video conference with the consent of each Party. Each Party
shall be responsible for its own expenses for participating in each JDC.
Meetings of the JDC shall be effective only if a majority of the representatives
of each Party are present or participating.

 

- 39 -

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

FINAL VERSION

 

5.3 Joint Commercialization Committee.

5.3.1 Formation and Purpose. Within […***…] ([…***…]) days after the Original
Effective Date, the Parties shall establish a joint commercialization committee
(the “JCC”), which shall perform the primary functions of:

(a) facilitating cooperation and coordination between the Parties regarding
Commercialization matters;

(b) designing, implementing, monitoring, reviewing and discussing the
Commercialization Plan and Commercialization budget for the Product, including
progress and performance thereunder, and for proposing updates or amendments to
the Commercialization Plan and Commercialization budget for approval by the JSC;

(c) monitoring, reviewing, coordinating, and discussing the overall progress of
Commercialization under this Agreement; and

(d) providing regular updates, and making recommendations (as appropriate), to
the JSC regarding the foregoing matters.

5.3.2 Membership of the JCC. The JCC shall consist of […***…] ([…***…])
representatives designated by each of Orexigen and Takeda and shall operate by
consensus with each Party having one (1) vote. Additional representatives having
relevant expertise may from time to time be invited to attend JCC meetings;
provided, however, any such representatives who are not employees of a Party or
its Affiliates shall be subject to such representative’s written agreement to
comply with the requirements of this Agreement.

5.3.3 Meetings of the JCC. The JCC shall meet at least […***…] ([…***…]) times
annually during the Term or at such other frequency as mutually agreed by the
Parties. The JCC shall meet on such dates and at such times as agreed to by
Orexigen and Takeda, with all scheduled in-person meetings to alternate between
an Orexigen site and a Takeda site as designated by the respective Party prior
to such meeting, or at other locations as determined by the JCC. Meetings may be
held by audio or video conference with the consent of each Party. Each Party
shall be responsible for its own expenses for participating in meetings of the
JCC. Meetings of the JCC shall be effective only if a majority of the
representatives of each Party are present or participating.

5.4 Joint Manufacturing Committee.

5.4.1 Formation and Purpose. Within […***…] ([…***…] days after the Original
Effective Date, the Parties shall establish a joint manufacturing committee (the
“JMC”) which will have strategic oversight of the manufacture and distribution
of the Products in and for the Territory, including receiving updates from
Orexigen regarding the Third Party Manufacturers, and monitoring the production
capabilities of the Third Party Manufacturers in order that Takeda may forecast
when Takeda demand for the Products in a given […***…] exceed (or are likely to
exceed) the maximum production capability of the Third Party Manufacturers in
such […***…]; and overseeing the arrangements for the distribution of Products
which are to be delivered as specified on the relevant binding order.

 

- 40 -

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

FINAL VERSION

 

5.4.2 Membership of the JMC. The JMC shall consist of […***…] ([…***…])
representatives designated by each of Orexigen and Takeda and shall operate by
consensus with each Party having one (1) vote. Additional representatives having
relevant expertise may from time to time be invited to attend JMC meetings;
provided, however, any such representatives who are not employees of a Party or
its Affiliates shall be subject to such representative’s written agreement to
comply with the requirements of this Agreement.

5.4.3 Meetings of the JMC. The JMC shall meet at least […***…] ([…***…]) times
annually during the Term or at such other frequency as mutually agreed by the
Parties. The JMC shall meet on such dates and at such times as agreed to by
Orexigen and Takeda, with all scheduled in-person meetings to alternate between
an Orexigen site and a Takeda site as designated by the respective Party prior
to such meeting, or at other locations as determined by the JMC. Meetings may be
held by audio or video conference with the consent of each Party. Each Party
shall be responsible for its own expenses for participating in meetings of the
JMC. Meetings of the JMC shall be effective only if a majority of the
representatives of each Party are present or participating.

5.5 Additional Committees. The Parties shall discuss such other committees as
the Parties deem necessary or desirable for the management of the Collaboration.
Any Committee may establish and delegate duties to other committees or
sub-Committees on an “as-needed” basis to oversee particular projects or
activities. Each such sub-Committee shall be constituted and shall operate as
the establishing Committee determines; provided that each Party shall have the
right to equal representation on any such sub-Committee. Sub-Committees may be
established on an ad hoc basis for purposes of a specific project, or on such
other basis as the applicable Committee may determine. Each sub-Committee and
its activities shall be subject to the oversight, review and approval of, and
shall report to, the Committee that established such sub-Committee. In no event
shall the authority of the sub-Committee exceed that specified for the relevant
Committee in this Article 5.

5.6 General Committee Procedures.

5.6.1 General Responsibilities. The Committees will be responsible in the first
instance for developing mutual agreement between the Parties on matters within
the Committee’s jurisdiction, and for making recommendations to the JSC. After
approval by the JSC, the designated lead Party will implement the plan, subject
to the oversight of the relevant Committee.

5.6.2 Chairperson. Each Committee will be led by a representative of one of the
Parties (the “Chairperson”), appointed as follows: (a) Orexigen shall select
from its representatives a Chairperson for each of the JDC for the period
commencing on the Original Effective Date and ending on […***…] and Takeda shall
select from its representatives a Chairperson for the JDC for the period
commencing on […***…] and ending on […***…], and (b) Takeda shall select from
its representatives a Chairperson for the JSC for the period commencing on the
Original Effective Date and ending on […***…] and Orexigen shall select from its
representatives a Chairperson for the JSC for the

 

- 41 -

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

FINAL VERSION

 

period commencing on […***…] and ending on […***…]. Thereafter, selection of the
Chairperson for such Committees will alternate between the Parties on a Calendar
Year basis. A Takeda representative shall be the Chairperson of the JCC
throughout the Term. An Orexigen representative shall be the Chairperson of the
JMC unless or until Manufacturing responsibilities are transferred to Takeda
pursuant to Section 4.2; and thereafter a Takeda representative shall be the
Chairperson of the JMC.

5.6.3 Responsibilities. The Chairperson shall have only those responsibilities
set forth in this Section 5.6.3. The Chairperson of each Committee shall be
responsible for calling meetings, preparing and circulating an agenda in advance
of each meeting of such Committee, provided that a Chairperson shall call a
meeting of the applicable Committee promptly upon the written request of either
Party to convene such a meeting. In addition, each Chairperson shall bear the
responsibility for preparing written draft minutes of that Committee’s meetings
in reasonable detail and for distributing such draft minutes to all members of
that Committee for comment and review within […***…] ([…***…]) days after the
relevant meeting. The members of the Committee shall have […***…] ([…***…]) days
to provide comments. Each Chairperson shall incorporate timely received comments
and distribute revised minutes to all members of that Committee for their final
review and approval within […***…] ([…***…]) days after the relevant meeting.

5.6.4 Membership on Committees. Each representative of a Party may serve on more
than one Committee as appropriate in view of the individual’s expertise and may
be substituted by another person with notice to the other Party.

5.6.5 Limitations of Committee Powers. Each Committee shall have only such
powers as are specifically delegated to it hereunder and shall not be a
substitute for the rights of the Parties. Without limiting the generality of the
foregoing, no Committee shall have any power to amend this Agreement. Any
amendment to the terms and conditions of this Agreement shall be implemented
pursuant to Section 14.7.

5.6.6 Authority. The Parties agree that, in voting on matters as described in
this Article 5, it shall be conclusively presumed that each voting member of the
JSC or other Committee has the authority and approval of such member’s
respective senior management in casting his or her vote.

5.7 Committee Decision-Making.

5.7.1 Consensus; Good Faith; Action Without Meeting. Subject to the terms of
this Section 5.7, each Committee will take action by consensus, assuming a
quorum for such Committee is present, with each Party having one (1) vote. The
members of each Committee shall act in good faith to cooperate with one another
to reach agreement with respect to issues to be decided by the Committee. Action
that may be taken at a meeting of a Committee also may be taken without a
meeting if a written consent setting forth the action so taken is signed by all
of the Committee representatives of each Party.

5.7.2 Failure to Reach Consensus by a Committee. In the event that any matter
before a Committee that is required to be resolved by mutual agreement of the

 

- 42 -

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

FINAL VERSION

 

members thereof is unable to be resolved and agreed within […***…] ([…***…])
days of its initial consideration (or such other time period as mutually agreed
by the Parties), then such matter shall be escalated to and resolved by the JSC;
provided that such Committee may escalate the matter to the JSC prior to the
expiration of such period with the consent of both Parties.

5.7.3 Failure to Reach Consensus by the JSC. If the JSC cannot reach consensus
within […***…] ([…***…]) days (or such other time period as mutually agreed by
the Parties) with respect to any Dispute escalated from another Committee or
within […***…] ([…***…]) days of such Dispute arising at the JSC, with the
exception of Disputes related to the safety of a Product, the JSC shall submit
the respective positions of the Parties with respect to such Dispute for
discussion in good faith and resolution by the Chief Executive Officer of
Orexigen, or such other person with decision-making authority designated by
Orexigen from time to time, and the Chief Executive Officer of Takeda’s
Affiliate, Takeda Pharmaceuticals U.S.A., Inc., or such other person with
decision-making authority designated by Takeda from time to time (collectively,
the “Executive Officers”). The Executive Officers shall meet promptly to discuss
the Dispute submitted and to determine a resolution. If the Executive Officers
are unable to resolve the Dispute within […***…] ([…***…]) days of submission of
such Dispute to the Executive Officers (or such other time period as mutually
agreed by the Parties), then, (a) […***…] and (b) […***…].

5.8 Orexigen’s Membership in Committees. Orexigen’s membership in any Committee
shall be at its sole discretion, as a matter of right and not obligation, for
the sole purpose of participation in governance, decision-making, and
information exchange with respect to activities within the jurisdiction of such
Committee. At any time during the Term, Orexigen shall have the right to
withdraw from membership in any or all of the Committees upon […***…] ([…***…])
days’ prior written notice to Takeda, which notice shall be effective as to the
relevant Committee upon the expiration of such […***…] ([…***…]) day
period. Following the issuance of such notice for a given Committee, (a)
Orexigen’s membership in such Committee shall be terminated and (b) Orexigen
shall have the right to continue to receive the data, plans, reports, and
information it would otherwise be entitled to receive under this Agreement. If,
at any time, following issuance of such a notice, Orexigen wishes to resume
participation in any Committee, Orexigen shall notify Takeda in writing and,
thereafter, Orexigen’s representatives to such Committee shall be entitled to
attend

 

- 43 -

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

FINAL VERSION

 

any subsequent meeting of such Committee and to participate in the activities
of, and decision-making by, such Committee as provided in this Article 5 as if
such notice had not been issued by Orexigen pursuant to this Section 5.8. If the
JSC is disbanded, then any data, plans, reports, and information originally to
be disclosed through the JSC shall be provided by such Party directly to the
other Party.

5.9 Alliance Managers. Promptly after the Original Effective Date, each Party
shall appoint an individual (other than an existing member of the JSC) to act as
the alliance manager for such Party (each, an “Alliance Manager”). Each Alliance
Manager shall thereafter be permitted to attend meetings of any Committee as a
nonvoting observer. The Alliance Managers shall be the primary point of contact
for the Parties regarding the Collaboration activities contemplated by this
Agreement and shall facilitate communication regarding all activities hereunder.
The Alliance Managers shall lead the communications between the Parties and
shall be responsible for following-up on decisions made by the JSC. The name and
contact information for such Alliance Manager, as well as any replacement(s)
chosen by Orexigen or Takeda, in their sole discretion, from time to time, shall
be promptly provided to the other Party in accordance with Section 14.3.

6. LICENSES

6.1 Licenses to Takeda for Products.

6.1.1 Subject to the terms and conditions of this Agreement, Orexigen hereby
grants to Takeda (a) an exclusive (even as to Orexigen, except to the extent set
forth in Article 4 and Sections 2.2, 2.2.4(c), 3.5, and 6.3), nontransferable
(except as provided in Section 14.5) license in the Field in the Territory, with
the right to grant sublicenses solely in accordance with Section 6.2, under the
Orexigen Intellectual Property, to make and have made (except to the extent set
forth in Article 4), use, sell, offer to sell, import, and otherwise Develop and
Commercialize all Products during the Term; and (b) a non-exclusive license,
with the right to grant sublicenses solely in accordance with Section 6.2, under
the Orexigen Intellectual Property to (i) make and have made (except to the
extent set forth in Article 4) Product outside the Territory for use or sale
solely inside the Territory, and (ii) conduct Clinical Trials outside the
Territory for the purpose of submitting Regulatory Filings in the Territory.

6.1.2 Subject to the terms and conditions of this Agreement, Orexigen hereby
grants to Takeda an exclusive (even as to Orexigen, except to the extent set
forth in Section 3.5), nontransferable (except as provided in Section 14.5)
license in the Field in the Territory, with the right to grant sublicenses
solely in accordance with Section 6.2, under the Product Trademarks, to use and
display the Product Trademarks in connection with Commercialization, as provided
under and in accordance with this Agreement.

6.1.3 Subject to the terms and conditions of this Agreement, Orexigen hereby
grants to Takeda a non-exclusive, nontransferable (except as provided in
Section 14.5) license in the Field in the Territory, with the right to grant
sublicenses solely in accordance with Section 6.2, under the Orexigen
Trademarks, to use and display the Orexigen Trademarks in connection with
Commercialization, as provided under and in accordance with Section 3.8.2.

 

- 44 -

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

FINAL VERSION

 

6.2 Sublicensing. Takeda shall have the right to grant sublicenses through
multiple tiers with respect to the rights licensed to Takeda under Section 6.1
to any Affiliate of Takeda solely in accordance with Sections 6.2.1 through
6.2.5. Takeda […***…] with respect to the rights licensed to Takeda under
Section 6.1 to any Third Party […***…] of Orexigen, which shall not to be
unreasonably withheld, conditioned, or delayed. In the event Orexigen consents
to the grant of such a Sublicense, such Sublicense shall be granted solely in
accordance with Sections 6.2.1 through 6.2.5:

6.2.1 such Sublicense shall refer to this Agreement and shall be subordinate to
and consistent with the terms and conditions of this Agreement, and shall not
limit either the ability of Takeda (individually or through the activities of
its Sublicensee) to fully perform all of its obligations under this Agreement or
Orexigen’s rights under this Agreement;

6.2.2 in such Sublicense, the Sublicensee shall agree in writing to be bound to
Takeda by terms and conditions substantially similar to, or less favorable to
the Sublicensee than, the corresponding terms and conditions of this Agreement;

6.2.3 promptly after execution of the Sublicense, and specifically excluding any
sublicenses granted to an Affiliate of Takeda, Takeda shall provide a complete
and correct copy of such Sublicense to Orexigen;

6.2.4 Takeda shall remain responsible for the performance of this Agreement and
the performance of its Sublicensees hereunder, and shall cause such Sublicensee
to enable Takeda to comply with all applicable terms and conditions of this
Agreement; and

6.2.5 each Sublicense shall terminate immediately upon the termination of this
Agreement (in whole or only with respect to the rights that are subject to such
Sublicense).

For clarity, any references to Sublicense or Sublicensee in Sections 6.2.1
through 6.2.5 shall also mean sublicense or sublicensee, as the case may, be
with respect to Takeda’s Affiliates.

6.3 Licenses to Orexigen.

6.3.1 Subject to the terms and conditions of this Agreement, Takeda hereby
grants to Orexigen a non-exclusive, royalty-free, non-transferable (except as
provided in Section 14.5) license in the Field in the Territory, with the right
to grant sublicenses solely in accordance with Section 6.2, under the Takeda
Intellectual Property solely as and to the extent necessary to enable Orexigen
to perform Development and Commercialization activities under this Agreement,
and/or other development activities as contemplated in Section 2.2.4(c), with
respect to Products.

6.3.2 Subject to the terms and conditions of this Agreement, Takeda hereby
grants to Orexigen a non-exclusive, nontransferable (except as provided in
Section 14.5) license in the Field in the Territory, with the right to grant
sublicenses solely in accordance with Section 6.2, under the Takeda Trademarks,
to use and display the Takeda Trademarks in

 

- 45 -

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

FINAL VERSION

 

connection with Orexigen’s Co-Promotion of the Products in the Field throughout
the Territory, as provided under and in accordance with Section 3.8.3.

6.4 Patent Marking. The packaging for each Product Commercialized by Takeda
under this Agreement shall be marked (to the extent not prohibited by Laws) with
a notice that such Product is sold under a license from Orexigen.

6.5 No Implied Licenses; Upstream Agreements.

6.5.1 No Implied Licenses. No license or other right is or shall be created or
granted hereunder by implication, estoppel, or otherwise. All licenses and
rights are or shall be granted only as expressly provided in this Agreement. All
rights not expressly granted by Orexigen under this Agreement are reserved by
Orexigen and may not be used by Takeda for any purpose.

6.5.2 Upstream Agreements. Takeda’s rights under this Agreement with respect to
the Upstream Patents are expressly subject to the applicable terms and
conditions of the applicable Upstream Agreements as set forth below in this
Section 6.5.2. Without limiting the foregoing, Takeda acknowledges and agrees
that:

(a) the license granted in Section 6.1.1 is non-exclusive with respect to the
Patents licensed to Orexigen pursuant to the GSK License, and the grant to any
and all such Patents is limited to the GSK Field;

(b) Takeda’s right to sublicense under Section 6.2, with respect to the GSK
License is subject to delivery of notice to GSK pursuant to Section 2.1(ii) of
the GSK License; and

(c) under the OHSU Agreement, OHSU retains the right to use the “Assigned
Therapeutic Patent Rights” (as defined in the OHSU Agreement) for educational
and research purposes.

6.6 Parallel Trade. Orexigen shall use Commercially Reasonable Efforts to cause
Orexigen’s and its Affiliates’, licensees’ and sublicensees’ advertising,
promotional or other commercialization activities with respect to a Product not
to result in sales of the Product from Canada (including its provinces and
territories) and Mexico into the Territory.

7. FINANCIAL TERMS

7.1 Upfront Payment. As reimbursement for research and development of Products
conducted by Orexigen, Takeda has paid to Orexigen a payment of Fifty Million
Dollars ($50,000,000) within ten (10) Business Days after the Original Effective
Date. Such payment shall not be refundable or returnable in any event, nor shall
it be creditable against royalties or other payments.

7.2 Milestone Payments. As reimbursement for research and development of
Products conducted by Orexigen, Takeda has made each of the milestone payments
to Orexigen described in Section 7.2.1 and shall make milestone payments to
Orexigen described in

 

- 46 -

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

FINAL VERSION

 

Section 7.2.2. Such milestone payments shall not be refundable or returnable in
any event, nor shall they be creditable against royalties or other payments.

7.2.1 Development Milestones. The Parties acknowledge and agree that as of the
Amended and Restated Effective Date, Takeda has made each of the development
milestone payments set forth in the table in this Section 7.2.1, below, to
Orexigen with respect to the first and only the first achievement of each of the
corresponding milestone events set forth in the table in this Section 7.2.1,
below, within […***…] days after the date of achievement of the applicable
milestone event.

 

Milestone Event

   Payment  

Regulatory Approval in the Territory

   $ 20 million   

The later to occur of (i) Delivery of Launch Supplies; or (ii) Regulatory
Approval in the Territory

   $ 10 million   

First Commercial Sale in the Territory

   $ 70 million   

For purposes of this Section 7.2.1, “Delivery of Launch Supplies” shall be
deemed to occur if and only […***…].

7.2.2 Net Sales Milestones. Takeda shall pay, in accordance with Section 7.4, to
Orexigen the applicable Net Sales threshold milestone payments set forth in the
table in this Section 7.2.2, below, the first and only the first time during the
Term that the total aggregate Net Sales of all Products (including all
Indications and formulations of such Products) in any Calendar Year by Takeda,
its Affiliates and its Sublicensees in the Territory reach or exceed the
relevant amounts set forth in the table in this Section 7.2.2, below.

 

Annual Calendar Year Net Sales for Products in the Territory in all Indications

   Payment  

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

 

- 47 -

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

FINAL VERSION

 

Annual Calendar Year Net Sales for Products in the Territory in all Indications

   Payment  

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

7.2.3 Anniversary Milestones. Takeda shall pay to Orexigen a milestone payment
of Fifteen Million Dollars ($15,000,000) on each of: (a) the […***…] ([…***…])
anniversary of […***…], (b) the […***…] ([…***…]) anniversary of the […***…],
and (c) the […***…] ([…***…]) anniversary of the […***…]. Such milestone
payments shall not be refundable or returnable in any event, nor shall they be
creditable against royalties or other payments.

7.2.4 Superiority Milestones. Takeda shall make the following milestone payments
to Orexigen within thirty (30) days after the corresponding milestone dates set
forth in the table in this Section 7.2.4 below; provided that each of the
following conditions is satisfied as of each such milestone date in order for
the corresponding milestone payment to be due: (i) a Superiority Claim […***…];
(ii) there is no […***…]; (iii) if such milestone date is […***…] or earlier,
the aggregate Net Sales for the […***…] period preceding such milestone date
shall have been at least $[…***…]; and (iv) if such milestone date is after
[…***…], the aggregate Net Sales for the […***…] period preceding such milestone
date shall have been at least $[…***…]. The Parties agree that Takeda will
provide such Net Sales information to Orexigen in accordance with Section 7.4.
For the avoidance of doubt, if as of a milestone date, any of the foregoing
applicable conditions are not satisfied, then no payment shall be required for
such milestone date.

 

Milestone Date

   Payment  

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

[…***…]

   $ […***…]   

For clarity, […***…] acknowledges and agrees that, as of […***…], it is not
[…***…], or to […***…].

For example, if […***…]

 

- 48 -

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

FINAL VERSION

 

[…***…].

7.3 Royalty Payments.

7.3.1 Running Royalties. Subject to Sections 7.3.2 through 7.3.5 and in
accordance with Section 7.4, Takeda shall pay to Orexigen incremental royalties
on aggregate Net Sales by Takeda, its Affiliates and its Sublicensees of all
Products in the Territory during a Calendar Year in the amounts set forth in the
table in this Section 7.3.1, below.

 

Portion of Annual Net Sales for Products in the Territory in all Indications

   Royalty Rate  

Up to $[…***…]

     […***… ]% 

Over $[…***…] and up to $[…***…]

     […***… ]% 

Over $[…***…] and up to $[…***…]

     […***… ]% 

Over $[…***…]

     […***… ]% 

7.3.2 Royalty Duration. All royalties payable under Section 7.3.1 shall be
payable for the duration of the Royalty Term for such Product in the Territory
subject to the provisions of Sections 7.3.3 through 7.3.5. Such royalties are
due and payable with respect to the substantial value provided to Takeda through
access to the information, assistance, materials and data made available to or
provided to Takeda pursuant to this Agreement and Orexigen’s substantial
expertise applied to research and Development of the Product. Following the
Royalty Term, Takeda shall continue to pay Orexigen a royalty of […***…] percent
([…***…]%) of aggregate Net Sales of the Product by Takeda for […***…] the
Product Trademarks.

7.3.3 Royalty Reduction – Generic Competition. In the event a Product is subject
to Generic Competition in the Territory, then, beginning in the […***…]
following the […***…] period during which Generic Competition has been
determined to exist in accordance with Section 1.51 at the applicable level
noted below, the royalty rates set forth in Section 7.3.1 (without giving effect
to any reduction under Section 7.3.5) shall be reduced in the Territory: (a) by
[…***…] percent ([…***…]%) if the […***…] of such Generic Product(s) sold during
the applicable […***…] period exceed […***…] percent ([…***…]%) and are not more
than […***…] percent ([…***…]%) of the Product’s […***…];

 

- 49 -

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

FINAL VERSION

 

(b) by […***…] percent ([…***…]%) if the units of such Generic Product(s) sold
during the applicable […***…] period exceed […***…] percent ([…***…]%) and are
not more than […***…] percent ([…***…]%) of the Product’s […***…]; (c) by
[…***…] percent ([…***…]%) if the units of such Generic Product(s) sold during
the applicable […***…]period exceed […***…] percent ([…***…]%) and are not more
than […***…] percent ([…***…]%) of the Product’s […***…]; and (d) to […***…]
percent ([…***…]%) of Net Sales if the […***…] of such Generic Product(s) sold
during the applicable […***…] period exceed […***…] percent ([…***…]%) of the
Product’s […***…]. For clarity, the Product’s […***…] shall be determined in
accordance with Section 1.44(a) and (b). Such reduction shall be first applied
with respect to the Territory starting with sales in the […***…] following the
first […***…] period where the sales of the Generic Product(s) in the Territory
exceed the applicable level noted above of the […***…] of the applicable
Product, and shall expire on the day after […***…]; provided, however, following
the Royalty Term Takeda shall continue to pay Orexigen a royalty of […***…]
percent ([…***…]%) of aggregate Net Sales of the Product by Takeda for […***…]
the Product Trademarks. As an example, in the case where Takeda has total annual
Net Sales for two Products of over $[…***…] and less than $[…***…] in the
Territory and Generic Competition is established for either or both of the
Products such that […***…] of Generic Products have exceeded […***…] percent
([…***…]%), but are less than […***…] percent ([…***…]%), of the sum of all
[…***…] of all Products and all […***…] of Generic Products sold in the
Territory, then the royalty rate of […***…] percent ([…***…]%) for aggregate Net
Sales of both Products will be reduced by […***…] ([…***…]%) to a royalty rate
of […***…] percent ([…***…]%). For the avoidance of doubt, if the royalty rate
set forth in Section 7.3.1 has already been reduced pursuant to Section 7.3.4,
then the royalty reduction set forth in Section 7.3.4 shall no longer apply and
the royalty reduction set forth in this Section 7.3.3 shall take precedence.

7.3.4 Royalty Reduction – Patent Expiry or Sole Takeda Patent.

(a) Expiration of All Valid Claims Prior to End of Royalty Term. In the event
the expiration of the last to expire Collaboration Patent containing a Valid
Claim Covering a Product in the Territory occurs prior to the expiration of the
Royalty Term in the Territory, the royalty rate set forth in Section 7.3.1
(without giving effect to any reduction under Section 7.3.5) for such Product in
the Territory shall be reduced by […***…] percent ([…***…]%) for the remainder
of the applicable Royalty Term. Such royalty reduction shall become effective on
the day after the last day of the Calendar Quarter in which such last to expire
Valid Claim expires.

(b) Royalty Term Based Solely on Takeda Patent. With respect to a Product in the
Territory, if all of the events described in the following subsections
(i) through (iv) occur, then the royalty rate set forth in Section 7.3.1
([…***…]) for such Product shall be […***…] until the […***…] containing a
[…***…] in the Territory: (i) […***…] in the Territory with respect to such
Product ([…***…]) have expired; (ii) it is after […***…] after First Commercial
Sale of such Product in the Territory; (iii) […***…]

 

- 50 -

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

FINAL VERSION

 

[…***…]; and (iv) there is a […***…]. Such royalty […***…] shall become
effective on the […***…] in which the events described in subsections
(i) through (iv) occur.

7.3.5 Royalty Reduction – Anti-Stacking. Takeda may offset a total of […***…]
percent ([…***…]%) of any royalty payments based on Net Sales paid by Takeda to
a Third Party pursuant to any necessary Third Party License against any royalty
payments due to Orexigen under Section 7.3.1; provided, however, that in no
event shall the total royalty payable to Orexigen on any Product as a result of
such offset be less […***…] percent ([…***…]%)%) of the royalty otherwise
payable under Section 7.3.1. In the event that […***…] percent ([…***…]%) of
such Third Party payments exceeds the amount of payments withheld by Takeda
under this Section 7.3.5 in any Calendar Quarter, the excess may be carried over
as a credit on the same basis into succeeding Calendar Quarters.

7.4 Royalty Payment Reports. After the First Commercial Sale of a Product and
throughout the Royalty Term for such Product, Takeda shall furnish to Orexigen a
written report, within […***…] ([…***…]) days after the end of each Calendar
Quarter (or portion thereof if this Agreement terminates during a Calendar
Quarter), showing the amount of royalty or Net Sales milestone payments due for
such Product for such Calendar Quarter (or portion thereof). Royalty or Net
Sales milestone payments for each Calendar Quarter shall be due at the same time
as such written report for the Calendar Quarter. With each quarterly payment,
Takeda shall deliver to Orexigen a full and accurate accounting to include at
least the following information: (a) the gross sales for the applicable Product
by Takeda, its Affiliates and Sublicensees in the currency in which sales were
made and in Dollars after application of the exchange rate during the reporting
period as reported in subsection (e) below; (b) the deductions by category of
permitted deductions set forth in the Net Sales definition; (c) the Net Sales
for the applicable Product by Takeda, its Affiliates, and Sublicensees in the
currency in which sales were made and in Dollars after the application of the
exchange rate during the reporting period as reported in subsection (e) below;
(d) the royalties or Net Sales milestone payments payable in Dollars which shall
have accrued hereunder in respect of such Net Sales and the basis for
calculating those royalties; (e) the exchange rates and other methodology used
in converting into Dollars, from the currencies in which sales were made; and
(f) withholding taxes, if any, required by Laws to be deducted in respect of
such royalties. In addition, Takeda will send to Orexigen no later than […***…]
([…***…]) days following the end of each Calendar Quarter a preliminary
statement setting forth the actual Net Sales for the first […***…] ([…***…])
months of such Calendar Quarter and estimated Net Sales for the […***…]
([…***…]) month of such Calendar Quarter, the calculation of royalties or Net
Sales milestone payments due (based on such actual and estimated Net Sales in
the Territory) and, if applicable, the exchange rate to be utilized by Takeda to
convert a local currency payment to Dollars.

7.5 Manner of Payment. All payments to be made by Takeda hereunder shall be made
in Dollars by wire transfer of immediately available funds to such U.S. bank
account as shall be designated by Orexigen. Late payments shall bear interest at
the rate provided in Section 7.10.

 

- 51 -

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

FINAL VERSION

 

7.6 Records Retention. Commencing with the First Commercial Sale of a Product by
Takeda, Takeda shall keep, and shall cause each of its respective Affiliates,
and Sublicensees, if any, to keep, full, true, and accurate books of accounting
in accordance with IFRS or GAAP, as applicable, containing all particulars that
may be necessary for the purpose of calculating all royalties payable to
Orexigen under this Article 7, for a period of […***…] ([…***…]) years after the
Calendar Year in which such sales occurred, in sufficient detail to permit
Orexigen to confirm the accuracy of royalties paid hereunder.

7.7 Audits. During the Term and for a period of […***…] ([…***…]) years
thereafter, at the request and expense of Orexigen under this Article 7, Takeda
shall permit an independent, certified public accountant of nationally
recognized standing appointed by Orexigen, and reasonably acceptable to Takeda,
at reasonable times and upon reasonable notice, but in no case more than […***…]
per Calendar Year thereafter, to examine such records as may be necessary for
the sole purpose of verifying the calculation and reporting of Net Sales and the
correctness of any royalty payment made under this Agreement for any period
within the preceding […***…] ([…***…]) Calendar Years. Results of any such
examination shall be made available to both Takeda and Orexigen. The
independent, certified public accountant shall disclose to Orexigen only the
royalty amounts which the independent auditor believes to be due and payable
hereunder to Orexigen, details concerning any discrepancy from the amount paid
and the amount due, and shall disclose no other information revealed in such
audit. Any and all records examined by such independent accountant shall be
deemed Takeda’s Confidential Information which may not be disclosed by said
independent, certified public accountant to any Third Party other than a party
to an Upstream Agreement as required under the Upstream Agreements. If, as a
result of any inspection of the books and records of Takeda, it is shown that
payments received by Orexigen under this Agreement were less than the amount
which should have been received, then Takeda shall make all payments required to
be made to eliminate any discrepancy revealed by said inspection within […***…]
([…***…]) days. Orexigen shall pay for such audits, except that in the event
that Takeda underpaid royalty payments by more than […***…] percent ([…***…]%)
during the period in question as per the audit, Takeda shall pay the reasonable
costs of the audit. Takeda acknowledges and agrees that Dante shall have the
right to audit Orexigen’s books in accordance with this Section 7.7.

7.8 Currency Exchange. All payments under this Agreement shall be payable, in
full, in Dollars. For the purposes of computing Net Sales in a currency other
than Dollars, such currency shall be converted into Dollars as calculated using
the monthly average exchange rate between each currency of origin and Dollars as
reported by Bloomberg or an equivalent resource as agreed by the Parties.

7.9 Taxes.

7.9.1 Cooperation and Coordination. The Parties acknowledge and agree that it is
their mutual objective and intent to appropriately calculate and minimize, to
the

 

- 52 -

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

FINAL VERSION

 

extent feasible and legal, taxes payable with respect to any payments under this
Agreement and that they shall use Commercially Reasonable Efforts to cooperate
and coordinate with each other to achieve such objective. Without limiting the
generality of the foregoing, the Parties shall use Commercially Reasonable
Efforts to cooperate and coordinate with each other in completing and filing
documents required under the provisions of any applicable Laws (including
treaties) in connection with the making of any required tax payment or
withholding payment, in connection with a claim of exemption from, or
entitlement to, a reduced or zero rate of withholding or in connection with any
claim to a refund of or credit for any such payment.

7.9.2 Payment of Tax. All payments made by Takeda to Orexigen pursuant to this
Agreement shall be made without reduction for any taxes, charges or remittance
fees. If applicable Laws require that taxes be deducted and withheld from a
payment made pursuant to this Agreement, the remitting Party shall (a) deduct
those taxes from the payment; (b) pay the taxes to the proper taxing authority;
and (c) send evidence of the obligation together with proof of payment to the
other Party promptly following that payment. Orexigen shall pay any and all
taxes that are due and payable by Orexigen on payments made to the Orexigen
under this Agreement.

7.9.3 Tax Residence Certificate. A Party (including any entity to which this
Agreement may be assigned, as permitted under Section 14.5) receiving a payment
pursuant to this Agreement shall provide the remitting Party appropriate
certification from relevant governmental authorities that such Party is a tax
resident of that jurisdiction, if such receiving Party wishes to claim the
benefits of an income tax treaty to which that jurisdiction is a party. Upon the
receipt thereof, any deduction and withholding of taxes shall be made at the
appropriate treaty tax rate.

7.9.4 Assessment. Either Party may, at its own expense, protest any assessment,
proposed assessment, or other claim by any governmental authority for any taxes,
interest or penalties or seek a refund of such amounts paid if permitted to do
so by applicable Laws. The Parties shall cooperate with each other in any
protest or refund by providing records and such additional information as may
reasonably be necessary for a Party to pursue such protest or refund.

7.10 Interest Due. Without limiting any other rights or remedies available to
Orexigen, Takeda shall pay Orexigen interest on any payments that are not paid
on or before the date such payments are due under this Agreement at a rate equal
to the lesser of (a) […***…] percent ([…***…]%) per month or (b) the maximum
applicable legal rate, calculated on the total number of days payment is
delinquent.

8. REPRESENTATIONS, WARRANTIES, AND COVENANTS; DISCLAIMERS; LIMITATION OF
LIABILITY

8.1 Mutual Representations and Warranties. Each Party hereby represents and
warrants to the other Party, (i) as of the Original Effective Date (with
references to “this Agreement” in this Section 8.1 being deemed references to
the Original Collaboration Agreement) and (ii) as of the Amended and Restated
Effective Date

 

- 53 -

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

FINAL VERSION

 

(with references to “this Agreement” in this Section 8.1 being deemed references
to this Amended and Restated Collaboration Agreement), that:

8.1.1 such Party is duly organized, validly existing and in good standing under
the Laws of the jurisdiction of its incorporation and has full corporate power
and authority to enter into this Agreement and to carry out the provisions
hereof;

8.1.2 execution of this Agreement and the performance by such Party of its
obligations hereunder have been duly authorized;

8.1.3 this Agreement has been duly executed and delivered on behalf of such
Party, and constitutes a legal, valid, binding obligation, enforceable against
it in accordance with the terms hereof;

8.1.4 the performance of this Agreement by it does not create a material breach
or default under any other agreement to which it is a party;

8.1.5 the execution, delivery and performance of this Agreement by such Party
does not conflict with any agreement, instrument or understanding, oral or
written, to which it is a party or by which it is bound, nor violate any Law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over such Party;

8.1.6 no government authorization, consent, approval, license, exemption of or
filing or registration with any court or governmental department, commission,
board, bureau, agency or instrumentality, domestic or foreign, under any Laws
currently in effect, is or will be necessary for, or in connection with, the
transaction contemplated by 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 except as may be required to
obtain clearance under the HSR Act; and

8.1.7 neither such Party, nor any of its employees, officers, subcontractors, or
consultants who have rendered services relating to the Products: (a) has ever
been debarred or is subject to debarment or convicted of a crime for which an
entity or person could be debarred by the FDA under 21 U.S.C. Section 335a or
(b) has ever been under indictment for a crime for which a person or entity
could be so debarred.

8.2 Additional Representations and Warranties of Orexigen. Orexigen hereby
represents and warrants to Takeda, as of the Original Effective Date, that:

8.2.1 Orexigen owns or otherwise Controls the Orexigen Patents set forth in
Exhibit 1.99;

8.2.2 all of its employees and officers involved in Development are obligated to
assign to Orexigen all inventions made during the course of and as a result of
their association with Orexigen that are materially related to the Product and
to maintain as confidential the Confidential Information of Orexigen;

 

- 54 -

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

FINAL VERSION

 

8.2.3 Orexigen has not granted any right or license to any Third Party under the
Orexigen Intellectual Property that would materially conflict or interfere with
any of the rights or licenses granted to Takeda hereunder;

8.2.4 to its knowledge, Orexigen has no reason to believe that the patents
within the Orexigen Patents that are listed on Exhibit 1.99 as of the Original
Effective Date are invalid or unenforceable;

8.2.5 subject to the provisions of the Upstream Agreements, Orexigen’s right,
title and interest to all the Orexigen Patents set forth in Exhibit 1.99 are
free of any lien or security interest;

8.2.6 Orexigen has made available to Takeda all agreements between Orexigen and
any Third Party relating to any Clinical Trial or other material Development
activities that relate to Contrave in the Territory;

8.2.7 to its knowledge, no Third Party (a) is infringing any Orexigen Patents or
has misappropriated any Orexigen Know-How or (b) has challenged the ownership,
scope, duration, validity, enforceability, priority or right to use any Orexigen
Patents (including, by way of example, through the institution of or written
threat of institution of interference, reexamination, protest, opposition,
nullity or similar invalidity proceeding before the United States Patent and
Trademark Office (“USPTO”) or any analogous foreign entity) or any Orexigen
Know-How;

8.2.8 to its knowledge, […***…], the manufacture, use, offer for sale, sale or
importation of Contrave in the Territory, including Development and
Commercialization of Contrave, by Orexigen or Takeda (or their respective
Affiliates or Sublicensees) does not infringe any Patent of any Third Party and
does not misappropriate any technology of any Third Party;

8.2.9 […***…] Orexigen has received no notice from a Third Party regarding, nor
has any knowledge that any Third Party intends to assert, any claim that the
Development or Commercialization of Contrave infringes the intellectual property
rights of a Third Party;

8.2.10 prior to the Original Effective Date, Contrave has been developed,
manufactured, stored, labeled, distributed and tested by Orexigen and its
Affiliates and, to its knowledge, by any Third Parties acting on behalf of
Orexigen, in compliance in all material respects with all applicable Laws;

8.2.11 […***…], the Upstream Patents listed in Exhibit 1.99 are licensed or
assigned to Orexigen under the Upstream Agreements and are included in the
Orexigen Patents licensed to Takeda under this Agreement; and other than the
Patents listed in Exhibit 1.99,

 

- 55 -

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

FINAL VERSION

 

Orexigen does not Control, as of the Original Effective Date, any Patents
claiming the Products or their methods of use;

8.2.12 (a) except as set forth on Exhibit 8.2.12 and except for the Upstream
Agreements, there are no written licenses or other agreements to which Orexigen
or any of its Affiliates is a party that relate in any material respect to
(i) the Products in the Territory or (ii) any Patents relating to the Products
in the Territory; (b) the Upstream Agreements delivered by Orexigen to Takeda
were true, accurate and complete copies of such agreements on the date of
delivery and have not been modified, supplemented or amended since the date of
delivery; (c) each of the Upstream Agreements is in full force and effect;
(d) Orexigen is not in material breach of any Upstream Agreement, and, to
Orexigen’s knowledge, no other party to any Upstream Agreement is in material
breach thereof, in each respect in, any manner that would give an Upstream Party
the right to terminate such Upstream Agreement; (e) […***…], no party to any
Upstream Agreement has notified in writing any other party thereto of any
material breach thereof; (f) Dante has executed and delivered to Orexigen
written amendment to the Dante License, which gives Orexigen the right to grant
sublicenseable licenses under the Dante License to Takeda under this Agreement;
(g) there was no government funding of the research conducted under the OHSU
Agreement, and Section 5 of the OHSU Agreement, which purports to grant the U.S.
Government certain rights, has no force or effect; and (h) […***…];

8.2.13 Orexigen has made available to Takeda a true, accurate and complete copy
of NDA No. 20-0063, as updated as of the Original Effective Date;

8.2.14 Orexigen has made available to Takeda all material written correspondence
exchanged between Orexigen and the FDA prior to the Original Effective Date
regarding Contrave in the Territory;

8.2.15 except for filings pursuant to the HSR Act, if any, neither the execution
and delivery of this Agreement nor the performance hereof by Orexigen requires
Orexigen to obtain any permits, authorizations or consents from any governmental
authority or from any other person, firm or corporation, and such execution,
delivery and performance will not result in the breach of or give rise to any
right of termination, rescission, renegotiation or acceleration under, or
trigger any other rights under, any agreement or contract to which Orexigen is a
party or to which it may be subject that relates to the Orexigen Intellectual
Property or the Products;

8.2.16 to Orexigen’s knowledge, there is no written suit, proceeding,
arbitration, or litigation of any nature, civil, criminal, regulatory or
otherwise, in law or in equity, pending against Orexigen, any of its Affiliates
or Upstream Party, in each case in connection with the Orexigen Intellectual
Property, Products or the Upstream Agreements;

 

- 56 -

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

FINAL VERSION

 

8.2.17 Orexigen has conducted audits of its Third Party Manufacturers and Third
Party contract research organizations in accordance with GCP, GLP, and GMP, as
applicable, and has […***…]; and

8.2.18 Orexigen is not […***…] (i) the Development, Manufacturing and/or
Commercialization of the Products in the Territory, or (ii) Orexigen’s Third
Party Manufacturers’ […***…].

8.3 Additional Representations and Warranties of Takeda. Takeda hereby
represents and warrants to Orexigen, as of the Original Effective Date, that, to
its knowledge:

8.3.1 Takeda does not Control any intellectual property rights that relate to
the Products;

8.3.2 Takeda has not granted any right or license to any Third Party under the
Takeda Intellectual Property or other intellectual property rights Controlled by
Takeda that would materially conflict or interfere with any of the rights or
licenses granted to Orexigen hereunder; and

8.3.3 Except for filings pursuant to the HSR Act, if any, neither the execution
and delivery of this Agreement nor the performance hereof by Takeda requires
Takeda to obtain any permits, authorizations or consents from any governmental
authority or from any other person, firm or corporation, and such execution,
delivery and performance will not result in the breach of or give rise to any
right of termination, rescission, renegotiation or acceleration under, or
trigger any other rights under, any agreement or contract to which Takeda is a
party or to which it may be subject that relates to the Takeda Intellectual
Property or Products.

8.4 Mutual Covenants. Each Party hereby covenants to the other Party that:

8.4.1 all employees and officers of such Party or its Affiliates working under
this Agreement shall be under the obligation to assign all right, title and
interest in and to their Inventions, whether or not patentable, if any, to such
Party as the sole owner thereof, and under the obligation to maintain as
confidential the Confidential Information of such Party;

8.4.2 such Party shall perform its activities pursuant to this Agreement in
compliance with GLP, GCP, and GMP, in each case as applicable under the Laws and
regulations of the country and the state and local government wherein such
activities are conducted, and with respect to the care, handling and use in
research and Development activities hereunder of any non-human animals by or on
behalf of such Party, shall at all times comply

 

- 57 -

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

FINAL VERSION

 

(and shall ensure compliance by any of its subcontractors) with all Laws, and
also with the standards in the pharmaceutical industry for the development and
commercialization of pharmaceutical products;

8.4.3 neither Party shall employ (or, to its knowledge, use any contractor or
consultant that employs) any individual or entity debarred by the FDA (or
subject to a similar sanction of a Regulatory Authority), or, to its knowledge,
any individual who or entity which is the subject of an FDA debarment
investigation or proceeding (or similar proceeding of a Regulatory Authority),
in the conduct of its activities under this Agreement, and each contractor or
consultant used by a Party in connection with the conduct of Clinical Trials
under this Agreement shall be subject to a covenant that is the same or
substantially the same as the foregoing covenant; and

8.4.4 neither Party shall, during the Term, grant any right or license to any
Third Party relating to any of the intellectual property rights it Controls
which would conflict or interfere with any of the rights or licenses granted to
the other Party hereunder.

8.4.5 Competing Products. For the period commencing on the Original Effective
Date and ending on […***…], each of Takeda and Orexigen shall not, and shall
ensure that their respective Affiliates and sublicensees do not, (whether
directly or through a Third Party), commercialize in the Territory any
pharmaceutical product, other than (a) the Products or (b) […***…]. For the
avoidance of doubt, this Section 8.4.5 shall apply to any Successor of either
Party.

8.5 Additional Covenants of Orexigen.

8.5.1 Restrictions on Transfers and Liens. Orexigen covenants that it shall not
license, sell, assign or otherwise transfer to any person (including any
Affiliate of Orexigen) any Orexigen Patents or any Orexigen Know-How, or assign
or otherwise transfer any of the Upstream Agreements or any of its rights or
obligations thereunder to any person (including any Affiliate of Orexigen) (or
agree to do any of the foregoing) in any manner that would have a material
adverse impact on the rights granted to Takeda under this Agreement, except to
the extent permitted by, and in compliance with, Section 14.5. In addition,
Orexigen hereby covenants and agrees that after the Original Effective Date
Orexigen shall not incur or permit to exist (and shall cause each of its
Affiliates not to incur or permit to exist), with respect to any Orexigen
Patents or Orexigen Know-How, any lien, encumbrance, or security interest
(including in connection with any indebtedness) in any manner that would have a
material adverse impact on the rights granted to Takeda under this Agreement,
except to the extent permitted by, and in compliance with, Section 14.5.

8.5.2 Upstream Agreements. Orexigen covenants that it shall not (a) execute or
otherwise permit, and shall cause its Affiliates to refrain from executing or
otherwise permitting, any amendment, modification or waiver to any of the
Upstream Agreements in any manner that would have a material adverse impact on
the rights granted to Takeda under this Agreement without the prior written
consent of Takeda, such consent not to be unreasonably withheld, conditioned, or
delayed, or (b) materially breach any Upstream Agreement if such

 

- 58 -

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

FINAL VERSION

 

material breach would give rise to a termination right by the counterparty to
such Upstream Agreement or materially adversely impact the rights granted to
Takeda under this Agreement.

8.6 Additional Covenants of Takeda.

8.6.1 Compliance with Laws. Takeda covenants that it shall not engage in any
activities that use the Orexigen Intellectual Property in a manner that is
outside the scope of the license rights granted to it hereunder or knowingly
infringe the intellectual property rights of any Third Party in connection with
its activities pursuant to this Agreement.

8.6.2 Intellectual Property. Takeda shall not practice or exploit the Orexigen
Intellectual Property except to the extent expressly permitted under the terms
and conditions of this Agreement.

8.6.3 Standstill.

(a) Takeda agrees that, for a period of […***…] ([…***…]) years from the
Original Effective Date (the “Standstill Period”), neither it nor any of its
Affiliates will, without the prior written consent of Orexigen or the Orexigen
Board of Directors:

(i) acquire, offer to acquire, or agree to acquire, directly or indirectly, by
purchase or otherwise: (A) any voting securities or direct or indirect rights to
acquire any voting securities of Orexigen or any subsidiary if, after the
completion of such acquisition or proposed acquisition, Takeda would
beneficially own more than […***…] percent ([…***…]%) of the outstanding shares
of common stock of Orexigen (the “Common Stock”), or (B) any asset of Orexigen
or any subsidiary or division thereof;

(ii) make, or in any way participate in, directly or indirectly, any
“solicitation” of “proxies” (as such terms are used in the rules of the
Securities and Exchange Commission) to vote, or seek to advise or influence any
Person with respect to the voting of, any voting securities of Orexigen;

(iii) submit or publicly announce a proposal for, or offer to enter into (with
or without conditions) any merger, business combination or similar extraordinary
transaction involving Orexigen or its securities or assets;

(iv) form, join or in any way participate in any “group” (as defined in
Section 13(d)(3) of the Securities Exchange Act of 1934, as amended) in
connection with any of the foregoing; or

(v) request that Orexigen amend or waive any provision of this Section 8.6.3.

 

- 59 -

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

FINAL VERSION

 

(b) Notwithstanding the provisions of Section 8.6.3(a), Takeda’s obligations
under this Section 8.6.3 shall automatically terminate upon the earliest to
occur of:

(i) the acquisition by any Third Party of beneficial ownership of more than
[…***…] percent ([…***…]%) of the outstanding Common Stock (other than by
stockholders of Orexigen as of the Original Effective Date);

(ii) the commencement by any Person or Group of a tender offer or exchange offer
to acquire securities of Orexigen;

(iii) Orexigen publicly announces its execution of any agreement related to a
transaction described in (A) or (B) of this Section 8.6.3(b)(iii) or publicly
announces its Board of Directors’ authorization or recommendation of such
execution of any such agreement, or Orexigen publicly announces the consummation
of any transaction involving (A) the sale of all or substantially all of the
assets of Orexigen and its subsidiaries taken as a whole, or (B) a merger,
business combination, restructuring, recapitalization or similar transaction of
or with Orexigen and any of its subsidiaries taken as a whole;

(iv) Orexigen or any of its Affiliates becomes the subject of any bankruptcy,
insolvency or similar proceeding (except for any involuntary proceeding that is
dismissed within […***…] ([…***…]) days); or

(v) The public announcement by Orexigen or any other Person of any of the
foregoing.

(c) Notwithstanding the provisions of Section 8.6.3(a), it is understood and
agreed that Takeda shall not be prohibited from entering into an agreement and
having discussions with legal, accounting or financial advisors for the limited
purposes of evaluating any of the transactions contemplated in this
Section 8.6.3 and Takeda may initiate private discussions with, and submit
proposals confidentially to, the Executive Officer of Orexigen regarding a
transaction otherwise prohibited by this Section 8.6.3; provided that any such
proposal shall be expressly conditioned on approval of Orexigen’s Board of
Directors and shall by its terms not require public disclosure. Further,
notwithstanding the provisions of Section 8.6.3(a), Orexigen agrees that during
the Standstill Period, if the Orexigen Board of Directors has approved the
commencement of the solicitation of bids for any transaction within the scope of
Section 8.6.3(b)(iii), Orexigen will promptly notify Takeda of, and in good
faith permit Takeda to participate in, such bidding process.

(d) The provisions of this Section 8.6.3 shall not apply to any investment by
Takeda or an Affiliate of Takeda in Third-Party mutual funds or other similar
passive investment vehicles that hold interests in securities of Orexigen or any
of its Affiliates (and any such interests in securities shall not be taken into
account for the purpose of Section 8.6.3(a) including the […***…] percent
([…***…]%) exception contained therein), provided that the provisions of this
Section 8.6.3(d) shall apply with respect to any such fund or vehicle only for
so long as such fund or vehicle satisfies the requirements of paragraphs (i) and
(ii) of Rule 13d-1(b)(1) promulgated under the Securities Exchange Act of 1934,
as amended, with respect to any Orexigen securities held by such fund or
vehicle.

 

- 60 -

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

FINAL VERSION

 

(e) The termination or expiration of the Standstill Period will not terminate or
otherwise affect any of the provisions of this Agreement other than this
Section 8.6.3.

8.6.4 Covenant Not to Challenge Patents. Takeda covenants: (a) not to challenge
the validity, scope or enforceability of or otherwise oppose any Patent included
in the Orexigen Patents or any foreign counterparts thereof; (b) that it shall
include in all of its Sublicenses the obligation binding on the Sublicensee
under such Sublicense not to challenge the validity, scope or enforceability of
or otherwise oppose any such Patent; (c) that is shall include provisions in all
Sublicenses providing that if the Sublicensee challenges the validity or
enforceability of or otherwise opposes any such Patent, Takeda may terminate its
Sublicense agreement with such Sublicensee; and (d) if any such Sublicensee
challenges the validity, scope or enforceability of or otherwise opposes any
such Patent, Takeda shall terminate such Sublicense, and such Sublicensee shall
no longer have any rights under any such Patent. In the event that all or any
portion of this Section 8.6.4 is invalid, illegal or unenforceable, then the
Parties will use their best efforts to replace the invalid, illegal or
unenforceable provision(s) with valid, legal and enforceable provision(s).

8.7 DISCLAIMERS.

8.7.1 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, OREXIGEN MAKES NO
REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING
ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO THE OREXIGEN INTELLECTUAL PROPERTY, ANY OREXIGEN
CONFIDENTIAL INFORMATION OR ANY LICENSE GRANTED BY OREXIGEN UNDER ITS
INTELLECTUAL PROPERTY RIGHTS HEREUNDER, OR WITH RESPECT TO ANY PRODUCTS. EXCEPT
AS EXPRESSLY SET FORTH IN THIS AGREEMENT, OREXIGEN MAKES NO REPRESENTATIONS OR
WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE OREXIGEN
PATENTS ARE VALID OR ENFORCEABLE OR THAT USE OF THE OREXIGEN INTELLECTUAL
PROPERTY CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER
INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. EXCEPT AS EXPRESSLY SET FORTH
IN THIS AGREEMENT NOTHING IN THIS AGREEMENT (OR THE ORIGINAL COLLABORATION
AGREEMENT) SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT USE OF THE
OREXIGEN CONFIDENTIAL INFORMATION CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY
PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

8.7.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, TAKEDA MAKES NO
REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING
ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO THE TAKEDA INTELLECTUAL PROPERTY ANY TAKEDA CONFIDENTIAL
INFORMATION OR ANY LICENSE GRANTED BY TAKEDA UNDER ITS INTELLECTUAL PROPERTY
RIGHTS HEREUNDER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, TAKEDA MAKES
NO REPRESENTATIONS OR

 

- 61 -

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

FINAL VERSION

 

WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE TAKEDA
PATENTS ARE VALID OR ENFORCEABLE OR THAT USE OF THE TAKEDA INTELLECTUAL PROPERTY
CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL
PROPERTY RIGHTS OF ANY THIRD PARTY. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT NOTHING IN THIS
AGREEMENT (OR THE ORIGINAL COLLABORATION AGREEMENT) SHALL BE CONSTRUED AS A
REPRESENTATION OR WARRANTY THAT USE OF THE TAKEDA CONFIDENTIAL INFORMATION
CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL
PROPERTY RIGHTS OF ANY THIRD PARTY.

8.8 LIMITATION OF LIABILITY. EXCEPT FOR A BREACH OF ARTICLE 10, OR FOR CLAIMS OF
A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER ARTICLE 11, NEITHER
PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS
AGREEMENT (OR THE ORIGINAL COLLABORATION AGREEMENT), WHETHER UNDER ANY CONTRACT,
NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY
INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL
DAMAGES (INCLUDING LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF
BUSINESS).

8.9 Knowledge Standard. “Knowledge” means, as applied to a Party in this Article
8, that such Party shall be deemed to have knowledge of a particular fact or
other matter to the extent that a […***…]. For the avoidance of doubt, this
knowledge standard is intended to apply on each occasion that the term
“knowledge” (lower case), or any other formulation thereof, is used throughout
this Agreement.

9. INTELLECTUAL PROPERTY

9.1 Ownership of Inventions.

9.1.1 Inventorship of inventions conceived or reduced to practice solely by
either Party or jointly by the Parties (a) in the course of activities performed
under or contemplated by this Agreement or in the exercise of the rights
licensed under this Agreement or (b) relating to the composition of matter,
methods of making, methods of using (including methods of treatment or
administration), or formulations of Products (“Inventions”) shall be determined
by application of U.S. patent Laws pertaining to inventorship. If an Invention
is jointly invented by one or more employees, consultants, or contractors of
each Party, such Invention shall be jointly owned by the Parties (each such
Invention, a “Joint Invention”), and if one or more claims included in an issued
Patent or pending Patent application that is filed in a patent office in the
Territory claim such Joint Invention, such issued Patent or such pending Patent
application shall be jointly owned by the Parties (each such patent application
or patent, a “Joint Patent”). If an Invention is solely invented by an employee,
consultant, or contractor of a Party, such Invention shall be solely owned by
such Party, and any Patent application filed

 

- 62 -

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

FINAL VERSION

 

claiming such solely owned Invention shall also be solely owned by such Party.
Any such Patent application owned solely by Orexigen and any Patent issuing
therefrom shall be an “Orexigen Invention Patent”, and any such Patent
application owned solely by Takeda and any Patent issuing therefrom shall be a
“Takeda Invention Patent”.

9.1.2 Subject to the rights granted under this Agreement, each Party shall have
the right to practice and exploit Joint Inventions and Joint Patents, without
any obligation to account to the other for profits, or to obtain any approval of
the other Party to license, assign, or otherwise exploit Joint Inventions and
Joint Patents, by reason of joint ownership thereof, and each Party hereby
waives any right it 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 so consent. Each Party
agrees to be named as a party, if necessary, to bring or maintain a lawsuit
involving a Joint Invention or Joint Patent.

9.1.3 Each Party shall promptly disclose to the other Party in writing, and
shall cause its Affiliates, licensees and Sublicensees to so disclose, the
conception of any Invention. Each Party shall cause its Sublicensees and
Affiliates, and their respective employees, consultants, agents, or independent
contractors to so assign to such Party, such person’s or entity’s right, title
and interest in and to any Inventions, and intellectual property rights therein,
as is necessary to enable such Party to fully effect the ownership of such
Inventions, and intellectual property rights therein. Each Party shall also
include provisions in its relevant agreements with Third Parties performing
activities on its behalf pursuant to this Agreement, that effect the intent of
this Article 9. Each Party hereby appoints the other Party as attorney-in-fact
of such Party to execute and deliver all documents reasonably required to
evidence or record any assignment pursuant to this Agreement if such Party is
unable, after making reasonable inquiry, to obtain assistance of such other
Party with respect to any such document. Each Party shall, and shall cause its
Sublicensees and Affiliates, and their respective employees, consultants,
agents, or independent contractors to, cooperate with the other Party and take
all reasonable additional actions and execute such agreements, instruments and
documents as may be reasonably required to perfect such other Party’s right,
title and interest in and to Inventions, and intellectual property rights
therein, as set forth in this Section 9.1.

9.2 Prosecution of Collaboration Patents.

9.2.1 Filing, Prosecution and Maintenance of Collaboration Patents. Takeda shall
be responsible for the preparation, prosecution (including any interferences,
reissue proceedings and reexaminations) and maintenance of Takeda Patents.
Orexigen shall be responsible for the preparation, prosecution (including any
interferences, reissue proceedings and reexaminations) and maintenance of
Orexigen Patents. The Party bringing any action or proceeding as described in
Section 9.3.2 to enforce or defend any Collaboration Patent shall be further
responsible for any inter partes review proceedings at the USPTO (the “IPR
Proceedings”) relating to such Collaboration Patents. Each Party shall
reasonably consult with the other Party, and shall take any comments of the
other Party into good faith consideration, with respect to the preparation,
prosecution and maintenance of such Patents. Each Party shall provide to the
other Party copies of any papers relating to the filing, prosecution or
maintenance of such Patents promptly upon their being filed or received. The
Parties shall discuss and

 

- 63 -

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

FINAL VERSION

 

evaluate Joint Inventions and confer with each other regarding the advisability
of filing patent applications covering Joint Inventions and, if either Party
requests that a patent application be filed covering a Joint Invention, the
other Party shall not unreasonably withhold, condition, or delay its consent to
such filing. The Parties shall agree to whether Orexigen or Takeda have the
first right to control and manage the Joint Patents, and an appropriate
allocation of expenses related thereto, using a mutually acceptable independent
patent counsel, and reasonably consult with the other Party, and shall take any
comments of the other Party into good faith consideration, with respect to the
preparation, prosecution and maintenance of such Joint Patents. Each Party shall
provide to the other Party copies of any papers relating to the filing,
prosecution or maintenance of such Joint Patents promptly upon their being filed
or received. The Parties shall share equally all expenses incurred with respect
to the preparation, prosecution and maintenance of any and all Collaboration
Patents. Within […***…] ([…***…]) days after the end of each Calendar Quarter,
each Party shall report to the other Party and the JSC all expenses incurred by
such Party under this Section 9.2.1 for such Calendar Quarter. Any payments due
to such Party as specified in such report shall be paid within […***…] ([…***…])
days after receipt of such report. The reports and payments due pursuant to this
Section 9.2.1 for each Calendar Quarter shall include any reconciliations and
adjustments with respect to the prior Calendar Quarter necessary to effect the
sharing of expenses as set forth in Section 9.2.1.

9.2.2 Abandonment of Collaboration Patents. In no event will a Party permit a
Collaboration Patent under its Control to be abandoned in the Territory, or
elect not to file a new Patent application claiming priority to a Patent
application within such Patents either before such Patent application’s issuance
or within the time period required for the filing of an international (i.e.,
Patent Cooperation Treaty), regional or national Patent application, in each
case other than to optimize overall Patent protection of claimed inventions,
without the other Party first being given an opportunity to assume full
responsibility for the continued prosecution and maintenance of such Patents, or
the filing of such new Patent application included in such Patents. Each Party
shall provide the other Party with notice of the allowance and expected issuance
date of any Patent within the Collaboration Patents, and any of the
aforementioned filing deadlines, and each Party shall provide the other Party
with prompt notice as to whether it desires to file such new Patent application.
In the event that a Party decides either (a) not to continue the prosecution or
maintenance of a Patent application or Patent within the Collaboration Patents
under its control in the Territory or (b) not to file such new Patent
application requested to be filed by the other Party, in each case other than to
optimize overall Patent protection of claimed inventions, the Party shall
provide the other Party with notice of this decision at least […***…] ([…***…])
days prior to any pending lapse or abandonment thereof. In such event, the Party
shall provide the other Party with an opportunity to assume responsibility for
all costs reasonably associated with the filing or further prosecution and
maintenance of such Patent application and any Patent issuing thereon (such
filing to occur prior to the issuance of the Patent to which the application
claims priority or expiration of the applicable filing deadline, as set forth
above). In the event that the other Party assumes such responsibility for such
filing, prosecution and maintenance costs, the other Party shall have the right
to transfer the responsibility for such filing, prosecution and maintenance of
such Patent applications and Patents to patent counsel selected by it and
reasonably acceptable to the Party. In such case, Section 9.2.1 shall apply to
such Patent applications and Patents mutatis mutandis. Such Patent applications
and Patents shall otherwise continue to be subject to all of the terms and
conditions of this Agreement in the same manner and to the same extent as the
other Collaboration Patents.

 

- 64 -

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

FINAL VERSION

 

9.2.3 Upstream Agreements. Notwithstanding Section 9.2.1 and 9.2.2, Takeda
acknowledges that: […***…].

9.3 Enforcement of Collaboration Patents or Product Trademarks Against
Infringers.

9.3.1 Notice. In the event that Orexigen or Takeda become aware of a suspected
infringement of any Collaboration Patent by means of the manufacture, use, or
sale of a product substantially similar to or the same as a Product (a
“Competitive Product Infringement”), or any such Collaboration Patent is
challenged in any action or proceeding (other than any oppositions,
cancellations, interferences, reissue proceedings or reexaminations, which are
addressed above), or either Party becomes aware of the infringement of any
rights in a Product Trademark, such Party shall notify the other Party promptly,
and following such notification, the Parties shall confer.

9.3.2 Enforcement of Collaboration Patents and Product Trademarks.

(a) Takeda will have the first right, but not an obligation to, bring any action
or proceeding, at its own expense, to enforce or defend, as applicable, any
Collaboration Patent or Product Trademark in its own name and entirely under its
own direction and control, subject to the following. Orexigen shall reasonably
assist Takeda (at Takeda’s expense) in any such action or proceeding if so
requested, and shall lend its name to such actions or proceedings if requested
by Takeda or required by Laws. Orexigen shall have the right to participate and
be represented in any such suit by its own counsel at its own expense. No
settlement of any such action or proceeding will be entered into by Takeda
without the prior

 

- 65 -

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

FINAL VERSION

 

written consent of Orexigen, which consent shall not be unreasonably withheld,
conditioned, or delayed. Takeda shall consult with Orexigen and take any
Orexigen comments into good faith consideration with respect to the
infringement, claim construction, or defense of the validity or enforceability
of any claim in any Collaboration Patent or Product Trademark. Takeda shall
provide to Orexigen copies of any papers relating to the infringement or
validity litigation of any such involved Collaboration Patent or Product
Trademark promptly upon their being filed or received.

(b) If Takeda elects not to settle, or bring any action or proceeding as
described in Section 9.3.2(a) within […***…] ([…***…]) days after first
notifying Orexigen or being notified by Orexigen with respect thereto, then at
any time during the Term, Orexigen may bring such action or proceeding at its
own expense, in its own name and entirely under its own direction and control,
subject to the following. Takeda will reasonably assist Orexigen (at Orexigen’s
expense) in any such action or proceeding if so requested, and will lend its
name to such actions or proceedings if requested by Orexigen or required by
Laws. Takeda shall have the right to participate and be represented in any such
suit by its own counsel at its own expense with respect to a Competitive Product
Infringement. No settlement of any such action or proceeding which restricts the
scope, or adversely affects the enforceability, of any Collaboration Patent or
Product Trademark shall be entered into by Orexigen without the prior written
consent of Takeda, which consent shall not be unreasonably withheld,
conditioned, or delayed. Orexigen shall not knowingly take any action during
such litigation of any Collaboration Patent or Product Trademark that would
materially adversely affect them, without consultation with Takeda.

(c) Notwithstanding Section 9.3.2(b), each Party shall notify and provide the
other Party with copies, received by such Party, of any allegations of alleged
patent invalidity, unenforceability, or non-infringement of a Collaboration
Patent pursuant to a paragraph IV patent certification under 21 C.F.R. §§ 314.94
and 314.95 by a Third Party filing an Abbreviated New Drug Application under §
505(j), a New Drug Application under § 505(b)(2), or other similar patent
certification by a Third Party, and any foreign equivalent thereof, in each case
that concerns a Product (“Paragraph IV Certification”). Such notification and
copies shall be provided as soon as practicable and at least within […***…]
([…***…]) days (including, for clarity, non-Business Days) after the Party
receives such certification (in view of the forty-five (45) day period during
which litigation should be brought so as to afford a thirty (30) month stay of
approval under § 505, and shall be sent by facsimile and overnight courier to
the address set forth in Section 14.3. Takeda shall have the first right to
institute (or defend, as applicable), prosecute, and control such litigation
brought by a Third Party where Takeda is a named defendant, or by Takeda where
Takeda is a named plaintiff, in both cases irrespective of whether Orexigen is
also named as a defendant or plaintiff. If Takeda decides not to institute (or
defend, as applicable) such litigation, Takeda will give notice to Orexigen of
its decision within […***…] ([…***…]) days after receipt of notification of the
Paragraph IV Certification (or, if the remaining time period permitted by Law
for Takeda to commence such action is less than […***…] ([…***…]) days, within
half of the time period permitted by Law). Orexigen may then, but is not
required to, institute (or defend, as applicable), prosecute, and control such
litigation. Each Party shall cooperate fully with the other Party in such
litigation and shall provide reasonable assistance (including making available
to such other Party documents possessed by such Party that are reasonably
required by such other Party and making available personnel for interviews and
testimony) in any actions reasonably undertaken in accordance with this Section
9.3.2(c) to

 

- 66 -

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

FINAL VERSION

 

contest any such Paragraph IV Certification. At either Party’s request, the
other Party agrees to join any such litigation to enforce such Collaboration
Patent against the Third Party(ies) that made such Paragraph IV Certification.
Each Party shall have the right to approve any settlement that would adversely
affect the Collaboration Patents or such Party’s rights under this Agreement or
result in any liability or admission on behalf of such Party, such approval not
to be unreasonably withheld, conditioned, or delayed. Any recovery, by
settlement or otherwise, realized as a result of such litigation shall be
allocated in accordance with Section 9.3.3.

(d) Notwithstanding Sections 9.3.2(a), (b), and (c), Takeda acknowledges and
agrees that, […***…].

9.3.3 Damages. In the event that either Party exercises the rights conferred in
this Section 9.3 and recovers any damages or other sums in such action, suit or
proceeding or in settlement thereof, such damages or other sums recovered shall
first be subject to Section 9.3.2(d) […***…], and then shall be applied to all
out-of-pocket costs and expenses incurred by the Parties in connection
therewith, including attorneys’ fees. If such recovery is insufficient to cover
all such costs and expenses of both Parties, it shall be […***…]. If after such
reimbursement any funds remain from such damages or other sums recovered,
[…***…] percent ([…***…]%) of such funds shall be retained by the Party that
controlled the action or proceeding under this Section 9.3 and such other Party
shall receive […***…] percent ([…***…]%) of such funds.

9.3.4 Upstream Limitations. Each Party’s rights to enforce a Collaboration
Patent pursuant to this Section 9.3, or to defend against a challenge in any
action or proceeding described in Section 9.3.1, shall be subject to the
applicable provisions of any agreements between the Party Controlling such
Patents and its licensor. In the event of any conflict between this Section 9.3
and such other agreements, the provisions of the other agreements shall control.

 

- 67 -

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

FINAL VERSION

 

9.4 Patent Term Extension.

Orexigen and Takeda shall each cooperate with one another and shall use
Commercially Reasonable Efforts in obtaining any available marketing exclusivity
and patent term extension (including any pediatric exclusivity as may be
available) under the Drug Price Competition and Patent Term Restoration Act of
1984 (the “Hatch-Waxman Act”) and the Federal Food, Drug, and Cosmetic Act or
supplemental protection certificates with respect to Patents claiming the
Products, as applicable. If elections with respect to obtaining such patent term
extensions and marketing exclusivity are to be made, Takeda shall have the right
to elect to seek patent term extension, marketing exclusivity or supplemental
protection; provided that such election will be made so as to maximize the
period of marketing exclusivity for the Product. For such purpose, for all
Regulatory Approvals, Takeda shall provide Orexigen with written notice of any
expected Regulatory Approval at least […***…] ([…***…]) days prior to the
expected date of Regulatory Approval, as well as notice within […***…] ([…***…])
Business Days of receiving each Regulatory Approval confirming the date of such
Regulatory Approval.

9.5 Regulatory Patent Listing.

9.5.1 To the extent required by or permitted by Law, at all times prior to
transfer of the Regulatory Filings to Takeda during the Term, Orexigen will use
Commercially Reasonable Efforts to promptly, accurately and completely provide
to the applicable Regulatory Authorities, all applicable Patents for any Product
that has become the subject of a marketing application owned by Orexigen and
submitted to FDA, for listing in FDA’s Approved Products with Therapeutic
Equivalence Determinations (“Orange Book”) in accordance with the Hatch-Waxman
Act.

9.5.2 To the extent required by or permitted by Law, at all times after transfer
of the Regulatory Filings to Takeda during the Term, Takeda will use
Commercially Reasonable Efforts to promptly, accurately and completely provide
to the applicable Regulatory Authorities, all applicable Patents for any Product
that has become the subject of a marketing application owned by Takeda and
submitted to FDA, for listing in the Orange Book in accordance with the
Hatch-Waxman Act.

9.5.3 Prior to any listing under Section 9.5.1 or 9.5.2, the Parties will meet
to evaluate, identify all applicable Patents to be listed. Orexigen shall have
the right to finally determine the Patents to be listed under Section 9.5.1 and
Takeda shall have the right to finally determine the Patents to be listed under
Section 9.5.2.

9.6 Defense Against Claims of Infringement of Third Party Patents. If a Third
Party asserts that a Patent or other right owned by it is or has been infringed
by the manufacture, use, sale, offer for sale, or import of a Product in the
Territory, the Party first obtaining knowledge of such a claim shall immediately
provide the other Party notice of such claim through the JSC along with the
related facts in reasonable detail. In such event, unless the Parties otherwise
agree, Takeda shall have the obligation, at its expense, to control such defense
with respect to such Product. Orexigen shall cooperate with Takeda, at Takeda’s
reasonable request and expense, and shall have the right to be represented
separately by counsel of its own choice. Takeda shall also control settlement of
such claim; provided, however, that no settlement shall be entered into without
the prior consent of Orexigen if such settlement would adversely

 

- 68 -

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

FINAL VERSION

 

affect the rights and benefits of, or impose or adversely affect any obligations
on, Orexigen, such consent not being unreasonably withheld, conditioned, or
delayed.

9.7 Third Party Licenses.

9.7.1 If either Party reasonably determines that any Third Party intellectual
property rights, are necessary for the Development, manufacture, or
Commercialization of a Product, where such Third Party intellectual property
rights are necessary for use of any Product, or for any license that may be
required for the use or exploitation of Orexigen Intellectual Property as
contemplated under this Agreement for the discovery, research, manufacture, or
use of Products, then such Party will notify the JSC.

9.7.2 If the JSC determines that it needs to obtain one or more licenses from
one or more Third Parties for such activities, the JSC will determine which
Party will negotiate the most favorable license. The chosen Party shall obtain a
license to such Third Party intellectual property, with the right to sublicense,
in order to permit both Parties to conduct their obligations under this
Agreement. Subject to the foregoing, the terms and conditions involved in
obtaining such rights shall be determined at such chosen Party’s sole
discretion. If such chosen Party elects not to obtain rights to such Third Party
intellectual property, or is unsuccessful in obtaining such rights, then the
other Party shall have the right (but not the obligation) to negotiate and
obtain rights from such Third Party at its sole discretion and expense.

9.7.3 In the event that Takeda determines, in its reasonable commercial
judgment, that a license, sublicense or similar right from one or more Third
Parties is necessary in order to make, have made, use, offer to sell, sell or
import a Product, then Takeda or its Affiliates may acquire such a license,
sublicense or similar right. In accordance with Section 7.3.5, each Party shall
bear […***…] percent ([…***…]%) of the payments owed pursuant to any Third Party
licenses under intellectual property rights that are necessary for the
exploitation of, and cover the composition of matter or method of use of,
Products in the Field and in the Territory, other than pursuant to the Upstream
Agreements (a “Third Party License”). Orexigen shall be responsible for […***…]
owed pursuant to any Upstream Agreement.

10. CONFIDENTIALITY

10.1 Nondisclosure. Each Party agrees that, during the Term and for a period of
[…***…] ([…***…]) years thereafter, a Party (the “Receiving Party”) receiving
Confidential Information of the other Party (the “Disclosing Party”) shall (a)
maintain in confidence such Confidential Information using not less than the
efforts such Receiving Party uses to maintain in confidence its own confidential
or proprietary information of similar kind and value, (b) not disclose such
Confidential Information to any Third Party without the prior written consent of
the Disclosing Party, except for disclosures expressly permitted below, and (c)
not use such Confidential Information for any purpose except those permitted by
this Agreement (it being understood that this Section 10.1(c) shall not create
or imply any rights or licenses not expressly granted under this Agreement).
Notwithstanding anything to the contrary in the foregoing, the obligations of
confidentiality and

 

- 69 -

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

FINAL VERSION

 

non-use with respect to any trade secret within such Confidential Information
shall survive such […***…] period for so long as such Confidential Information
remains protected as a trade secret under applicable Laws.

10.2 Exceptions. The obligations in Section 10.1 shall not apply with respect to
any portion of the Confidential Information that the Receiving Party can show by
competent proof:

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

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

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

10.2.4 is now, or hereafter becomes, through no act or failure to act on the
part of the Receiving Party, or any of its Affiliates, generally known or
available, either before or after it is disclosed to the Receiving Party;

10.2.5 is independently discovered or developed by or on behalf of the Receiving
Party or any of its Affiliates without the use of Confidential Information
belonging to the Disclosing Party; or

10.2.6 is the subject of written permission to disclose provided by the
Disclosing Party.

10.3 Authorized Disclosure. Subject to the limitations in Section 2.2.9(e), the
Receiving Party may disclose Confidential Information belonging to the
Disclosing Party to the extent (and only to the extent) such disclosure is
reasonably necessary in the following instances:

10.3.1 filing or prosecuting patents;

10.3.2 regulatory filings and obtaining regulatory approvals for Products;

10.3.3 prosecuting or defending litigation, including responding to a subpoena
in a Third Party litigation;

10.3.4 subject to Section 10.5, complying with Laws (including the rules and
regulations of the Securities and Exchange Commission or any national securities
exchange) and with applicable court orders;

 

- 70 -

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

FINAL VERSION

 

10.3.5 potential or actual acquirers, merger partners or assignees, investment
bankers, lenders or other potential financial partners and their and each of
their respective Affiliates’ directors, employees, consultants, contractors and
agents, 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 the obligations in this Article 10; 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 10.3.5 to treat such Confidential Information as
required under this Article 10; and

10.3.6 on a “need to know basis” in order for the Receiving Party to exercise
its rights or fulfill its obligations under this Agreement, to Affiliates,
potential or actual collaborators (including sublicensees or potential
sublicensees), potential or actual research and development collaborators,
potential or actual subcontractors, and their and each of the Parties’ and their
respective Affiliates’ directors, employees, consultants, contractors and
agents, 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 the obligations in this Article 10; 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 10.3.6 to treat such Confidential Information as
required under this Article 10.

If and whenever any Confidential Information is disclosed in accordance with
this Section 10.3, 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 Receiving Party is
required to make a disclosure of the other Party’s Confidential Information
pursuant to Sections 10.3.3 or 10.3.4, the Receiving Party shall, except where
not reasonably possible and subject to Section 10.5, notify the Disclosing Party
of the Receiving Party’s intent to make such disclosure pursuant to this
Section 10.3 sufficiently prior to making such disclosure so as to allow the
Disclosing Party adequate time to take whatever action it may deem appropriate
to protect the confidentiality of the information.

10.4 Terms 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.

10.5 Securities Filings. Notwithstanding anything to the contrary in this
Article 10, any disclosure that is required by securities Laws, including the
Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as
amended, or the rules of a securities exchange or the Securities and Exchange
Commission or the securities regulations of any state or other jurisdiction, as
reasonably advised by the disclosing Party’s counsel, may be made; provided,
however, 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 which
describes or refers to the terms and conditions of this Agreement under the
Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as
amended, or any other applicable securities Laws, such Party shall notify the
other Party of such intention and shall provide such other Party with a copy of
relevant portions of the

 

- 71 -

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

FINAL VERSION

 

proposed filing at least […***…] ([…***…]) Business Days prior to such filing
(and any revisions to such portions of the proposed filing a reasonable time
prior to the filing thereof), including any exhibits thereto relating to the
terms and conditions of this Agreement. The Party making such filing shall use
Commercially Reasonable Efforts to obtain confidential treatment of the terms
and conditions of this Agreement that such other Party requests be kept
confidential or otherwise afforded confidential treatment, and shall only
disclose Confidential Information that it is reasonably advised by counsel is
legally required to be disclosed. No such notice shall be required under this
Section 10.5 if the description of or reference to this Agreement contained in
the proposed filing has been included in any previous filing made by the either
Party hereunder or otherwise approved by the other Party.

10.6 Relationship to Confidentiality Agreement. This Agreement supersedes the
Mutual Confidential Disclosure Agreement between Orexigen and Takeda, effective
as of April 20, 2010; provided that all “Confidential Information” disclosed or
received by the Parties thereunder shall be deemed “Confidential Information”
hereunder and shall be subject to the terms and conditions of this Agreement.

10.7 Publications.

10.7.1 Publication Plan. Within […***…] ([…***…]) days after the Original
Effective Date, each Party shall designate an individual to serve as that
Party’s “Publication Manager.” The Parties shall, through the Publication
Managers, cooperate in good faith and develop and execute a coordinated
publication plan in or for the Territory that will include strategy, budget and
policies for the publication activities related to the Products. The publication
plan will also cover intended timing, venue, media, review, authors and other
relevant considerations for each publication. The publication plan will be
included in the Commercialization Plan for approval by the JSC. A Party may
change its Publication Manager at any time upon written notice to the other
Party.

10.7.2 Publication of Clinical Trial Results. Takeda will have the right to
publish summaries of results of all Clinical Trials conducted by either Party
with respect to a Product after the Original Effective Date in Takeda’s Clinical
Trial register; provided, however, that Orexigen will have the right to review
all proposed publications prior to submission of such publication. The Parties
shall discuss and reasonably cooperate in order to facilitate the process to be
employed in order to ensure the publication of any such summaries of Clinical
Trials data and results as required under Laws on the Clinical Trial registry of
each respective Party, and shall provide the other Party at least […***…]
([…***…]) days prior notice to review the Clinical Trials results to be
published for the purposes of preparing any necessary Patent filings.

10.7.3 Publication Guidelines. All publications relating to the Licensed
Compounds and/or the Products shall be prepared, presented and/or published in
accordance with pharmaceutical industry accepted guidelines including:
(1) International Committee of Medical Journal Editors (ICMJE) guidelines,
(2) Uniform Requirements for Manuscripts Submitted to Biomedical Journals:
Writing and Editing for Biomedical Publication,

 

- 72 -

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

FINAL VERSION

 

(3) Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines, and
(4) Principles on Conduct of Clinical Trials.

10.8 Publicity. As of the Original Effective Date, the Parties shall issue the
press release announcing the existence of this Agreement in the form and
substance as set forth on Exhibit 10.8. Each Party agrees not to issue any press
release or other public statement disclosing information relating to this
Agreement or the transactions contemplated hereby that contains information not
previously publicly disclosed in accordance with this Section 10.8 without the
prior written consent of the other Party, not to be unreasonably withheld,
conditioned, or delayed; provided, however, that the Party intending to make any
such press release or other public statement relating to this Agreement shall
not disclose any Confidential Information that the other Party reasonably deems
inappropriate for disclosure.

10.9 Third Party Information. Notwithstanding anything to the contrary in this
Agreement, Takeda acknowledges that it may be required to enter into appropriate
confidentiality agreements with or with respect to specific Third Party contract
manufacturers or other independent contractors engaged by Orexigen before
Orexigen can share with Takeda information relating to its agreement with such
Third Party(ies) or such Third Party(ies)’ confidential information as required
under this Agreement. In such case, Orexigen shall notify Takeda promptly of
such requirement, and the Parties shall cooperate to take such actions as are
necessary to enable Orexigen to comply with such confidentiality requirements of
Orexigen’s agreements with any such Third Party(ies).

11. INDEMNITY AND INSURANCE

11.1 Takeda Indemnity. Takeda shall indemnify, defend and hold harmless Orexigen
and its Affiliates, and their respective officers, directors, employees, agents,
licensors, and their respective successors, heirs and assigns and
representatives, (the “Orexigen Indemnitees”), from and against any and all
claims, threatened claims, damages, losses, suits, proceedings, liabilities,
costs (including reasonable legal expenses, costs of litigation and reasonable
attorney’s fees) or judgments, whether for money or equitable relief, of any
kind (“Losses and Claims”), to the extent arising out of or relating to,
directly or indirectly: (a) the practice by Takeda or its Affiliate or
Sublicensee of any license or sublicense granted to it under Sections 6.1 and
6.2; (b) the Commercialization or Development of the Product by Takeda or its
Affiliate or Sublicensee; (c) the Manufacture, use, handling, storage, sale or
other disposition of any Product by Takeda or its Affiliate or Sublicensee;
(d) the breach by Takeda of any warranty, representation, covenant or agreement
made by Takeda in this Agreement, or, if Orexigen exercises its option to
Co-Promote pursuant to Section 3.5, the Co-Promote Agreement; or (e) the
negligence, recklessness or willful misconduct (including to the extent such
negligence, recklessness or willful misconduct gives rise to product liability
Losses and Claims under any legal theory) of Takeda or its Affiliate or
Sublicensee, or any officer, director, employee, agent or representative
thereof; except, with respect to each of subsections (a) through (e) above, to
the extent such Losses and Claims arise directly or indirectly from the
negligence, recklessness or willful misconduct of any Orexigen Indemnitee or the
breach by Orexigen of any warranty, representation, covenant or agreement made
by Orexigen in this Agreement or, if Orexigen exercises its option to Co-Promote
pursuant to Section 3.5, the Co-Promote Agreement.

 

- 73 -

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

FINAL VERSION

 

11.2 Orexigen Indemnity. Orexigen shall indemnify, defend and hold harmless
Takeda and its Affiliates, and their respective officers, directors, employees,
agents, licensors, and their respective successors, heirs and assigns and
representatives (the “Takeda Indemnitees”), from and against any and all Losses
and Claims, to the extent arising out of or relating to, directly or indirectly:
(a) the practice by Orexigen or its Affiliate or sublicensee of any license or
sublicense granted to it under Section 6.3; (b) the Commercialization or
Development of the Products by Orexigen or its Affiliate or sublicensee, or the
commercialization or development of Products for use outside the Territory by
Orexigen or its Affiliate or sublicensee; (c) the Manufacture, use, handling,
storage, sale or other disposition of the Product by Orexigen or its Affiliate
or licensee (other than Takeda or its Affiliate or Sublicensee); (d) the breach
by Orexigen of any warranty, representation, covenant or agreement made by
Orexigen in this Agreement, or, if Orexigen exercises its option to Co-Promote
pursuant to Section 3.5, the Co-Promote Agreement; or (e) the negligence,
recklessness or willful misconduct (including to the extent such negligence,
recklessness or willful misconduct gives rise to product liability Losses and
Claims under any legal theory) of Orexigen or its Affiliate or licensee (other
than Takeda or its Affiliate or Sublicensee), or any officer, director,
employee, agent or representative thereof; except, with respect to each of
subsections (a) through (e) above, to the extent such Losses and Claims arise
directly or indirectly from the negligence, recklessness or willful misconduct
of any Takeda Indemnitee or the breach by Takeda of any warranty,
representation, covenant or agreement made by Orexigen in this Agreement or, if
Orexigen exercises its option to Co-Promote pursuant to Section 3.5, the
Co-Promote Agreement.

11.3 Indemnification Procedure. A claim to which indemnification applies under
Section 11.1 or Section 11.2 shall be referred to herein as an “Indemnification
Claim”. If any Person or Persons (collectively, the “Indemnitee”) intends to
claim indemnification under this Article 11, the Indemnitee shall notify the
other Party (the “Indemnitor”) in writing promptly upon becoming aware of any
claim that may be an Indemnification Claim (it being understood and agreed,
however, that the failure by an Indemnitee to give such notice shall not relieve
the Indemnitor of its indemnification obligation under this Agreement except and
only to the extent that the Indemnitor is actually prejudiced as a result of
such failure to give notice). The Indemnitor shall have the right to assume and
control the defense of the Indemnification Claim at its own expense with counsel
selected by the Indemnitor and reasonably acceptable to the Indemnitee;
provided, however, that an Indemnitee shall have the right to retain its own
counsel, with the fees and expenses to be paid by the Indemnitee, if
representation of such Indemnitee by the counsel retained by the Indemnitor
would be inappropriate due to actual or potential differing interests between
such Indemnitee and any other party represented by such counsel in such
proceedings. If the Indemnitor does not assume the defense of the
Indemnification Claim as described in this Section 11.3, above, the Indemnitee
may defend the Indemnification Claim but shall have no obligation to do so. The
Indemnitee shall not settle or compromise the Indemnification Claim without the
prior written consent of the Indemnitor, and the Indemnitor shall not settle or
compromise the Indemnification Claim in any manner which would have an adverse
effect on the Indemnitee’s interests (including any rights under this Agreement
or the scope or enforceability of the Orexigen Intellectual Property, or
Confidential Information or Patent or other rights licensed to Orexigen by
Takeda hereunder), without the prior written consent of the Indemnitee, which
consent, in each case, shall not be unreasonably

 

- 74 -

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

FINAL VERSION

 

withheld, conditioned, or delayed. The Indemnitee shall reasonably cooperate
with the Indemnitor at the Indemnitor’s expense and shall make available to the
Indemnitor all pertinent information under the control of the Indemnitee, which
information shall be subject to Article 10.

11.4 Dante Indemnity. […***…].

11.5 Insurance.

11.5.1 By Takeda. Takeda represents and covenants that as of the Original
Effective Date it is, and during the Term and for […***…] ([…***…]) years
thereafter it shall be, […***…] against liability and other risks associated
with the activities to be conducted by it under this Agreement and that such
[…***…] set forth in […***…].

11.5.2 By Orexigen. During the Term and for […***…] ([…***…]) years thereafter,
Orexigen shall either (a) maintain, at its sole expense, Clinical Trial and
product liability insurance relating to the Product that is comparable in type
and amount to the insurance customarily maintained by Orexigen with respect to
similar prescription pharmaceutical products that are marketed, distributed and
sold in the Territory, or (b) self insure for such risks.

12. TERM AND TERMINATION

12.1 Term; Expiration. This Agreement shall become effective as of the Original
Effective Date and shall continue in full force and effect until expiration as
described in this Section 12.1, unless earlier terminated pursuant to this
Article 12 (the “Term”), and shall expire upon the expiration of the Royalty
Term with respect to all Products in the Territory.

12.2 Termination for Cause.

12.2.1 Material Breach. Either Party (the “Non-Breaching Party”) may, without
prejudice to any other remedies available to it at law or in equity, terminate
this Agreement in its entirety in the event the other Party (the “Breaching
Party”) has materially breached this Agreement, and such breach has continued
for […***…] ([…***…]) days (the “Cure Period”) after written notice thereof is
provided to the Breaching Party by the Non-Breaching Party, such notice
describing the alleged material breach in sufficient detail to put the Breaching
Party on notice.

 

- 75 -

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

FINAL VERSION

 

12.2.2 Disagreement as to Material Breach; Cure Period. If the Parties
reasonably and in good faith disagree as to whether there has been a material
breach, the Party that disputes that there has been a material breach may
contest the allegation in accordance with Section 13.3. Notwithstanding the
preceding sentence, the Cure Period for any allegation made in good faith as to
a material breach under this Agreement will run from the date that written
notice was first provided to the Breaching Party by the Non-Breaching Party. Any
such termination of this Agreement under this Section 12.2 shall become
effective at the end of the Cure Period, unless the Breaching Party has cured
any such breach or default prior to the expiration of such Cure Period, or, if
such breach is not susceptible to cure within the Cure Period, then, the
Non-Breaching Party’s right of termination shall be suspended only if and for so
long as the Breaching Party has provided to the Non-Breaching Party a written
plan that is reasonably calculated to effect a cure and such plan is acceptable
to the Non-Breaching Party (such acceptance not to be unreasonably withheld,
conditioned, or delayed), and the Breaching Party commits to and carries out
such plan as provided to the Non-Breaching Party. The right of either Party to
terminate this Agreement as provided in this Section 12.2, shall not be affected
in any way by such Party’s waiver or failure to take action with respect to any
previous default. It is understood and acknowledged that, during the pendency of
such a Dispute, 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. Any payments that are made by one Party to the
other Party pursuant to this Agreement pending resolution of the Dispute shall
be promptly refunded if the panel determines pursuant to Section 13.3 that such
payments are to be refunded by one Party to the other Party.

12.3 Termination for Safety Reasons. Either Party shall have the right to
terminate this Agreement with respect to any Product in the Territory, without
liability for any compensation or other payment obligation to the other Party
due to such termination except as expressly specified in this Agreement, by
providing the other Party with at least […***…] ([…***…]) days prior written
notice of termination, if, at any time, (a) […***…] such Product, caused or is
likely to cause a fatal, life-threatening or other serious adverse safety event
that is reasonably expected, based upon then available data, to preclude
obtaining Regulatory Approval for such Product, or, if Regulatory Approval of
such Product has already been obtained, to preclude continued marketing of such
Product, or (b) […***…]. Notwithstanding anything to the contrary in the
foregoing, neither Party shall have the right to terminate this Agreement
pursuant to this Section 12.3 based on a safety concern […***…].

 

- 76 -

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

FINAL VERSION

 

12.4 Termination for Insolvency. To the extent permitted under Law, either Party
may terminate this Agreement, if, at any time, the other Party files in any
court or agency pursuant to any statute or regulation of any state or country, a
petition in bankruptcy for insolvency or for reorganization or for the
appointment of a receiver or trustee of the Party or of substantially all of its
assets, or if the other Party is served with an involuntary petition against it,
filed in any insolvency proceeding, and such petition shall not be dismissed
within […***…] ([…***…]) days after the filing thereof, or if the other Party
shall propose or be a party to any dissolution or liquidation, or if the other
Party shall make an assignment of substantially all of its assets for the
benefit of creditors. All licenses granted under or pursuant to any section of
this Agreement are and shall otherwise be deemed to be for purposes of
Section 365(n) of Title 11, United States Code (the “Bankruptcy Code”) licenses
of rights to “intellectual property” as defined in Section 101(56) of the
Bankruptcy Code. The Parties shall retain and may fully exercise all of their
respective rights and elections under the Bankruptcy Code. Upon the bankruptcy
of any Party, the non-bankrupt Party shall further be entitled to a complete
duplicate of, or complete access to, any such intellectual property, and such
intellectual property, if not already in its possession, shall be promptly
delivered to the non-bankrupt Party, unless the bankrupt Party elects to
continue, and continues, to perform all of its obligations under this Agreement.

12.5 Termination for Patent Challenge. Orexigen shall have the right to
terminate this Agreement immediately upon written notice if Takeda directly or
through a Third Party indirectly challenges the validity, scope or
enforceability of or otherwise opposes any Patent included in the Orexigen
Patents or any foreign counterparts thereof. Takeda shall have the right to
terminate this Agreement immediately upon written notice if Orexigen directly or
through a Third Party indirectly challenges the validity, scope or
enforceability of or otherwise opposes any Patent included in the Takeda Patents
or any foreign counterparts thereof. If a Sublicensee of Takeda challenges the
validity, scope or enforceability of or otherwise opposes any such Patent, then
Takeda shall, upon written notice from Orexigen, terminate such Sublicense.
Takeda shall include provisions in all Sublicenses providing that, if the
Sublicensee challenges the validity or enforceability of or otherwise opposes
any such Patent, Takeda may terminate its Sublicense agreement with such
Sublicensee. In the event that all or any portion of this Section 12.5 is
invalid, illegal or unenforceable, then the Parties will use Commercially
Reasonable Efforts to replace the invalid, illegal or unenforceable provision(s)
with valid, legal and enforceable provision(s).

12.6 Unilateral Termination by Takeda. Takeda shall have the right to terminate
this Agreement in its entirety for any reason or no reason upon […***…]
([…***…]) days prior written notice to Orexigen. Takeda shall be responsible for
any of its payment obligations accrued and unpaid as of the date of such notice
or that become due and owing during such notice period.

12.7 Consequences 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 hereunder and shall not be construed to limit any such rights or
remedies.

 

- 77 -

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

FINAL VERSION

 

12.7.1 Consequences of Termination by Orexigen or Takeda. In the event of
termination of this Agreement either by Orexigen pursuant to Section 12.2.1 (for
material breach), Section 12.4 (for insolvency), or Section 12.5 (for
challenge), or by Takeda pursuant to Section 12.3 (for safety) or Section 12.6
(unilateral right):

(a) Notwithstanding anything contained in this Agreement to the contrary, all
rights and licenses granted herein to Takeda shall terminate, and Takeda shall
cease any and all Development, Manufacturing, and Commercialization activities
with respect to all Products;

(b) all payment obligations hereunder shall terminate, other than those that are
accrued and unpaid as of the effective date of such termination or expiration;

(c) Orexigen will thereafter have all rights, on a fully paid-up and
royalty-free basis, previously licensed to Takeda hereunder, itself or with a
Third Party or through a Third Party sublicensee, to Develop and Commercialize
any and all Products at Orexigen’s sole discretion;

(d) Takeda hereby grants to Orexigen, effective as of the effective date of such
termination, an exclusive (even as to Takeda), transferable, fully paid-up,
royalty-free, sublicenseable license in the Field in the Territory, under the
Takeda Intellectual Property, to make, use, sell, offer to sell, import all
Products, and otherwise Develop and Commercialize Products;

(e) the JSC shall coordinate the wind-down of Takeda’s efforts under this
Agreement and Takeda, as soon as reasonably practical after the effective date
of such termination, will provide to Orexigen, as applicable and to the extent
permitted under any applicable Third Party contract, (i) any information,
materials, and data, including copies of all Clinical Trial data and results,
and all other information, and the like developed by or for the benefit of
Takeda relating to Products, including control of, and all information relating
to, the global safety database, and (ii) other documents to the extent relating
to Products that are necessary in the continued Development and
Commercialization of Products (including material documents and agreements
relating to the sourcing and Manufacture of a Product or, to the extent the
First Commercial Sale of a Product has occurred, for sale, promotion,
distribution, sale or use of such Product) throughout the Territory. Orexigen
shall have the right to assume all prosecution, maintenance, and enforcement
activities under Sections 9.2 through 9.6 with respect to Patents within the
Collaboration Patents. Takeda will cooperate with Orexigen to provide a transfer
of such material information, materials, data, and documents, and to assist
Orexigen with the prosecution, maintenance, and enforcement activities with
respect to Patents within the Collaboration Patents. At Orexigen’s request,
Takeda shall assign to Orexigen any and all Collaboration Patents and agreements
to which Takeda or its Affiliate and a Third Party are parties and that govern
the Development, Commercialization and Manufacturing activities conducted in
connection with Products prior to such termination, or if such assignment is not
permitted under the relevant agreement, (A) grant to Orexigen other rights to
provide to Orexigen the benefit of such non-assignable agreement, at Orexigen’s
expense, to the extent permitted under the terms of such non-assignable
agreement or (B) to the extent not permitted under the terms of such
non-assignable agreement, the Parties shall discuss in good faith an alternative
solution to enable Orexigen to receive, at Orexigen’s expense, the benefit of
the terms of such non-assignable agreement;

 

- 78 -

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

FINAL VERSION

 

(f) Subject to the payment of all amounts required under subsection 12.7.1(b),
Takeda shall have the right to sell or otherwise dispose of any inventory of any
Product on hand at the time of such termination or in process of manufacture;
provided, however, that, at Orexigen’s request, Takeda shall transfer to
Orexigen any Product that has not been sold or used within […***…] ([…***…])
[…***…] following such termination;

(g) Takeda shall transfer to Orexigen any and all Regulatory Filings directly
and solely related to any Products, including any INDs and NDAs, and, upon
Orexigen’ request, shall make available to Orexigen any other relevant
information reasonably related to such Regulatory Filings; and

(h) the license set forth in Section 6.3.1 shall survive.

12.7.2 Consequences of Termination by Takeda. In the event of termination of
this Agreement by Takeda pursuant to Section 12.2.1 (for material breach),
Section 12.4 (for insolvency) or Section 12.5 (for challenge):

(a) Notwithstanding anything contained in this Agreement to the contrary, all
rights and licenses granted herein to Orexigen shall terminate, and, upon
Takeda’s request, Orexigen shall cease any and all Development, Manufacturing,
and Commercialization activities with respect to all Products;

(b) Takeda will thereafter have all rights previously licensed to Orexigen
hereunder, itself or with a Third Party or through a Third Party sublicensee, to
Develop and Commercialize any and all Products at Takeda’s sole discretion;

(c) all licenses granted to Takeda shall continue in full force, in accordance
with the terms and conditions of this Agreement, provided, however,
notwithstanding anything to the contrary contained herein, such licenses shall
survive the Term and Orexigen’s reservation of rights contained in Section 6.1
shall cease;

(d) the JSC shall coordinate the wind-down of Orexigen’s efforts under this
Agreement and Orexigen, as soon as reasonably practical after the effective date
of such termination, will provide to Takeda, as applicable and to the extent
permitted under any applicable Third Party contract, (i) any information,
materials, and data, including copies of all Clinical Trial data and results,
and all other information, and the like developed by or for the benefit of
Orexigen relating to Products in the Territory, and (ii) other documents to the
extent relating to Products that are necessary in the continued Development and
Commercialization of Products (including material documents and agreements
relating to the sourcing and Manufacture of a Product or, to the extent the
First Commercial Sale of a Product has occurred, for sale, promotion,
distribution, sale or use of such Product) throughout the Territory. Orexigen
will cooperate with Takeda to provide a transfer of such material information,
materials, data, and documents. At Takeda’s request, Orexigen shall assign to
Takeda any and all Collaboration Patents and agreements to which Orexigen or its
Affiliate and a Third Party are parties and that govern Development,
Commercialization and Manufacturing activities conducted in or for the

 

- 79 -

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

FINAL VERSION

 

Territory in connection with Products for the Territory prior to such
termination, or if such assignment is not permitted under the relevant agreement
or if Orexigen conducts activities in or for countries outside of the Territory
under such agreement, (A) grant to Takeda other rights to provide to Takeda the
benefit of such non-assignable agreement, at Takeda’s expense, to the extent
permitted under the terms of such non-assignable agreement or (B) to the extent
not permitted under the terms of such non-assignable agreement, the Parties
shall discuss in good faith an alternative solution to enable Takeda to receive,
at Takeda’s expense, the benefit of the terms of such non-assignable agreement;

(e) Article 7 shall survive, provided, however, […***…] payment obligations
under […***…] shall be reduced by […***…] percent ([…***…]%); and

(f) Takeda shall use Commercially Reasonable Efforts to Develop and
Commercialize a Product in the Territory or, if Takeda does not materially
perform such obligation, Orexigen shall have the right to terminate the licenses
granted to Takeda in Article 6 as if Takeda were committing a material breach of
this Agreement, as provided in Section 12.2.

12.8 Consequences of Expiration. Following the expiration of the Term pursuant
to Section 12.1, the following terms shall apply:

12.8.1 Subject to the terms and conditions of this Agreement, following
expiration of the Term with respect to this Agreement in its entirety pursuant
to Section 12.1, Takeda shall have a perpetual, irrevocable, non-exclusive,
fully-paid and royalty-free right and license, with the right to grant
sublicenses, under the Orexigen Intellectual Property to make, have made, use,
sell, offer to sell and import such Products in the Field in the Territory.

12.8.2 Subject to the terms and conditions of this Agreement, following
expiration of the Term with respect to this Agreement in its entirety pursuant
to Section 12.1, Orexigen shall have a perpetual, irrevocable, non-exclusive,
fully-paid and royalty-free right and license, with the right to grant
sublicenses, under the Takeda Intellectual Property to make, have made, use,
sell, offer to sell and import such Products in the Field in the Territory.

12.8.3 Sections 2.2.5, 2.2.6, 2.2.9, 3.3.3, 3.4, 3.6, and 3.7 shall survive, to
the extent applicable to activities contemplated hereunder that are still being
carried out following expiration of the Term, and Article 10 shall survive with
respect to any information exchanged under such Sections for a period of […***…]
([…***…]) years after the date of disclosure of such information; provided that,
for clarity, any and all information shall be exchanged directly between the
Parties, and not through any Committees.

12.8.4 For as long as Takeda continues to use the Product Trademarks, (a) Takeda
shall pay Orexigen the Trademark Royalty provided in Section 7.3.2, and
(b) Takeda shall continue to have the license rights provided in Section 6.1.2.

 

- 80 -

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

FINAL VERSION

 

12.9 Survival. The following provisions shall survive termination or expiration
of this Agreement in its entirety, as well as any other provision which by its
terms or by the context thereof, is intended to survive such termination:
Articles 1, 7 (solely with respect to payments, including under Section 9.7.3,
that have accrued prior to the effective date of termination or expiration that
have remained unpaid), 10 (for the period set forth in Section 10.1 or such
longer period of time as set forth in Section 12.8.3), 13, and 14 and Sections
3.6, 6.5, 8.7, 8.8, 9.1, 11.1, 11.2, 11.3, 11.4 (for the time period set forth
therein), 12.7 (as applicable), 12.8 (as applicable), 12.9, and 12.10. All other
rights, licenses and obligations shall terminate upon expiration of this
Agreement.

12.10 No Limitation on Remedies. Notwithstanding anything to the contrary in
this Agreement, except as otherwise set forth in this Agreement, termination or
expiration of this Agreement shall not relieve the Parties of any liability or
obligation which accrued hereunder prior to the effective date of such
termination or expiration nor prejudice either Party’s right to obtain
performance of any obligation. 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 under applicable Law or in equity and
shall be entitled to offset the amount of any damages and costs obtained in a
final determination under Section 13.3 of monetary damages or costs (as
permitted by this Agreement) against the other Party against any amounts
otherwise due to such other Party under this Agreement.

13. DISPUTE RESOLUTION

13.1 Exclusive Dispute Resolution Mechanism. The Parties agree that the
procedures set forth in this Article 13 shall be the exclusive mechanism for
resolving any dispute, controversy, or claim between the Parties that may arise
from time to time pursuant to this Agreement relating to any Party’s rights or
obligations hereunder (collectively, “Disputes”) that is not resolved through
good faith negotiation between the Parties.

13.2 Resolution by Executive Officers. Except as otherwise provided in this
Section 13.2, in the event of any Dispute, the construction hereof, or the
rights, duties or liabilities of either Party hereunder, the Parties shall first
attempt in good faith to resolve such Dispute by negotiation and consultation
between themselves. In the event that such Dispute is not resolved on an
informal basis within […***…] ([…***…]) Business Days, either Party may, by
written notice to the other Party, refer the Dispute to the other Party for
attempted resolution by good faith negotiation within […***…] ([…***…]) days
after such notice is received. Any Disputes shall be referred to the Executive
Officers for attempted resolution. Except as set forth in Sections 5.7.3, 13.5
or 13.6, each Party may, in its sole discretion, seek resolution of any and all
Disputes that are not resolved under this Section 13.2 in accordance with
Section 13.3.

13.3 Alternative Dispute Resolution. The Parties acknowledge that they desire
for any alternative dispute resolution process to be conducted in an efficient,
speedy and economical manner and, to achieve that end, any

 

- 81 -

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

FINAL VERSION

 

Dispute shall be resolved by the Alternative Dispute Resolution provisions set
forth in Exhibit 13.3, the result of which shall be binding upon the Parties.
The Parties shall have the right to be represented by counsel in such a
proceeding.

13.4 Survivability. Any duty to engage in alternative dispute resolution under
this Agreement shall remain in effect and be enforceable after termination of
this Agreement for any reason.

13.5 Preliminary Injunctions. Notwithstanding anything in this Agreement to the
contrary, a Party may seek a temporary restraining order or a preliminary
injunction from any court of competent jurisdiction in order to prevent
immediate and irreparable injury, loss, or damage on a provisional basis,
pending the decision of the arbitrator(s) on the ultimate merits of any Dispute.

13.6 Patent Disputes. Notwithstanding anything in this Agreement to the
contrary, any and all issues regarding the scope, construction, validity, and
enforceability of any patent within the Territory shall be determined in a court
or other tribunal, as the case may be, of competent jurisdiction under the
applicable patent laws of the Territory.

13.7 Confidentiality. Any and all activities conducted under Sections 13.1
through 13.3, including any and all proceedings and decisions of arbitrator(s)
under Section 13.3, shall be deemed Confidential Information of each of the
Parties, and shall be subject to Article 10.

14. MISCELLANEOUS

14.1 HSR. Prior to taking any action pursuant to the terms of this Agreement for
which it is necessary to obtain clearance under the Hart-Scott-Rodino Antitrust
Improvement Act (“HSR Act”), the Parties shall each make or cause to be made all
filings and submissions required under the HSR Act with respect to such action
within such period of time that is reasonably necessary to obtain clearance
under the HSR Act prior to taking such action, and thereafter shall make any
other required submissions with respect to such action under the HSR Act and
otherwise use its reasonable best efforts to cause the expiration or termination
of the applicable waiting period under the HSR Act as soon as practicable. No
Party will extend any waiting period or comparable period under the HSR Act
without the prior written consent of the other Party.

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

 

- 82 -

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

FINAL VERSION

 

14.3 Notices. Any notice required or permitted to be given by this Agreement
shall be in writing and shall be (a) delivered by overnight courier with
tracking capabilities, (b) mailed postage prepaid by first class, registered or
certified mail addressed as set forth below unless changed by notice so given,
or (c) delivered by facsimile to the number set forth below unless changed by
notice so given, followed by delivery via either of the methods set forth in
Section 14.3(a) and (b):

If to Takeda:

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-Chome Chuo-ku

Osaka 540-8645

Japan

Attn: Head of Global Licensing & Business Development Department

Fax: (+81) 6-6204-2328

Attn: General Counsel, Legal Department

Fax: (+81) 6-6204-2055

With a copy to:

Takeda Pharmaceuticals U.S.A., Inc.

One Takeda Parkway

Deerfield, Illinois 60015

Attn: General Counsel

Fax: (224) 554-7831

Takeda Pharmaceuticals International, Inc.

One Takeda Parkway

Deerfield, Illinois 60015

Attn: Alliance Manager

Fax: (224) 554-7903

If to Orexigen:

Orexigen Therapeutics, Inc.

3344 N. Torrey Pines Ct., Suite 200

La Jolla, CA 92037

Attn: Chief Financial Officer

Fax: (858) 875-8650

Attn: General Counsel

Fax: (858) 875-8650

 

- 83 -

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

FINAL VERSION

 

With a copy to (which shall not constitute notice under this Agreement):

Orexigen Therapeutics, Inc.

3344 N. Torrey Pines Ct., Suite 200

La Jolla, CA 92037

Attn: Alliance Manager

Fax: (858) 875-8650

Cooley LLP

4401 Eastgate Mall

San Diego, CA 92121

Attn: L. Kay Chandler, Esq.

Fax: (858) 550-6014

Any such notice shall be deemed given on the date received if delivered in
accordance with Section 14.3(a), five (5) days after mailing if mailed in
accordance with Section 14.3(b), or the date of transmission if delivered in
accordance with Section 14.3(c). A Party may add, delete, or change the person
or address to which notices should be sent at any time upon written notice
delivered to the Party’s notices in accordance with this Section 14.3.

14.4 Force Majeure. Neither Party shall be liable for delay or failure in the
performance of any of its obligations hereunder if such delay or failure is due
to causes beyond its reasonable control, including acts of God, fires,
earthquakes, acts of war, terrorism, or civil unrest (“Force Majeure”);
provided, however, that the affected Party shall (a) promptly notify the other
Party, (b) use its Commercially Reasonable Efforts to avoid or remove such
causes of non-performance and to mitigate the effect of such occurrence, and
(c) continue performance with the utmost dispatch whenever such causes are
removed. When such circumstances arise, the Parties shall negotiate in good
faith any modifications of the terms of this Agreement that may be necessary or
appropriate in order to arrive at an equitable solution.

14.5 Assignment.

14.5.1 Each Party may, without the consent of the other Party, assign or
transfer all of its rights and obligations hereunder only to an Affiliate, of or
to a successor in interest by reason of merger or consolidation or sale of all
or substantially all of the assets of such Party relating to the subject matter
of this Agreement; provided, however, that (a) except as provided in
Section 14.5.5, such assignment includes all rights and obligations under this
Agreement, (b) such successor in interest shall have agreed as of such
assignment or transfer to be bound by the terms of this Agreement in a writing
provided to the non-assigning Party, and (c) where this Agreement is assigned or
transferred to an Affiliate, the assigning Party remains responsible for the
performance of this Agreement.

14.5.2 Subject to Section 14.5.1, this Agreement shall inure to the benefit of
and be binding on the Parties’ successors and assigns. Any assignment or
transfer in violation of the foregoing shall be null and void and wholly
invalid, the assignee or transferee in any such assignment or transfer shall
acquire no rights whatsoever, and the non-assigning non-transferring Party shall
not recognize, nor shall it be required to recognize, such assignment or
transfer. In

 

- 84 -

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

FINAL VERSION

 

the event that Takeda assigns or otherwise transfers this Agreement to an
Affiliate of Takeda, Takeda hereby agrees to be jointly and severally liable
with any such Affiliates for the actions of such Affiliates and for any and all
amounts that become due and payable hereunder to Orexigen. If Takeda assigns
this Agreement to an Affiliate, and such assignment has an adverse tax
consequence to Orexigen, then Takeda shall make additional payments to Orexigen
under this Agreement to provide Orexigen the payments that would have been due
to Orexigen had such assignment not occurred. For purposes of the preceding
sentence, adverse tax consequences shall be determined taking into account
ultimate actual utilization of any foreign tax credits arising as a result of
such assignment and the time value of money if there is any delay in the
utilization of such foreign tax credits, if any (based on applicable federal
rates).

14.5.3 Notwithstanding anything to the contrary in this Agreement, in the event
of any such assignment, the intellectual property rights of the acquiring party
(if other than one of the Parties to this Agreement) shall not be included in
the technology licensed to the other Party hereunder to the extent held by such
acquirer prior to such transaction, or to the extent such technology is
developed outside the scope of activities conducted with respect to Products.
The Orexigen Intellectual Property and the Takeda Intellectual Property shall
exclude any intellectual property owned or Controlled by a permitted assignee or
successor and not developed in connection with Products.

14.5.4 Notwithstanding anything to the contrary in this Agreement, Orexigen
shall have the right to assign its rights to receive payments pursuant to
Article 7, in whole or in part, to a Third Party in connection with the
monetization of Orexigen’s revenue stream under Article 7.

14.5.5 Notwithstanding anything to the contrary in this Agreement, without the
consent of Orexigen, Takeda may directly or through multiple tiers
(a) sublicense or transfer some or all of its rights or obligations hereunder to
one or more Affiliates, or (b) grant one or more of its Affiliates distribution
rights under this Agreement; provided, however, in each case, such sublicense,
transfer or grant of rights shall be subject to the provisions of Section 14.5.1
and 14.5.2.

14.6 Further Assurances. Each Party agrees to do and perform all such further
acts and things and shall execute and deliver such other agreements,
certificates, instruments and documents necessary or that the other Party may
deem advisable in order to carry out the intent and accomplish the purposes of
this Agreement and to evidence, perfect or otherwise confirm its rights
hereunder. Takeda and its Affiliates shall take all measures reasonably
requested by Orexigen to give effect to the provisions of this Agreement. Any
Affiliate that acquires rights hereunder will be deemed to be bound by the
provisions of this Agreement.

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

 

- 85 -

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

FINAL VERSION

 

14.8 Governing Law. This Agreement shall be governed by, enforced, and shall be
construed in accordance with the Laws of the State of New York, U.S. without
regard to any conflicts of law provision that would result in the application of
the Laws of any State other than the State of New York, U.S.

14.9 Relationship of the Parties. Each Party is an independent contractor under
this Agreement. Nothing contained herein is intended or is to be construed so as
to constitute Orexigen and Takeda as partners, agents or joint venturers.
Neither Party shall have any express or implied right or authority to assume or
create any obligations on behalf of or in the name of the other Party or to bind
the other Party to any contract, agreement or undertaking with any Third Party.
There are no express or implied third party beneficiaries hereunder.

14.10 Entire Agreement. This Agreement and the attached exhibits, together with
the Mutual Release Agreement between the Parties of even date herewith, the
Manufacturing Services Agreement, Quality Agreement, and Pharmacovigilance
Agreement, constitute the entire agreement between the Parties as to the subject
matter of this Agreement, the Mutual Release Agreement, Manufacturing Services
Agreement, Quality Agreement, and Pharmacovigilance Agreement. This Agreement
amends, restates, and supersedes the Original Collaboration Agreement in its
entirety as of the Amended and Restated Effective Date, and otherwise supersedes
and merges all prior and contemporaneous negotiations, representations,
agreements and understandings regarding the same including as provided in
Section 10.6, excluding the Mutual Release Agreement, Manufacturing Services
Agreement, Quality Agreement, and Pharmacovigilance Agreement. References to the
Collaboration Agreement in the Manufacturing Services Agreement, Quality
Agreement and Pharmacovigilance Agreement will be deemed to reference this
Agreement as of the Amended and Restated Effective Date.

14.11 Exports. Each Party agrees not to export or re-export, directly or
indirectly, any information, technical data, the direct product of such data,
samples or equipment received or generated under this Agreement in violation of
any applicable export control Laws.

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

14.13 Performance by Affiliates. Each Party recognizes that the other Party may
perform some or all of its obligations under this Agreement through Affiliates
to the extent permitted under this Agreement; provided, however, that such other
Party shall remain responsible for the performance by its Affiliates as if such
obligations were performed by such other Party.

 

- 86 -

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

FINAL VERSION

 

14.14 Counterparts; Electronic Delivery. This Agreement may be executed in
counterparts with the same effect as if both Parties had signed the same
document. All such counterparts shall be deemed an original, shall be construed
together and shall constitute one and the same instrument. Signatures to this
Agreement transmitted by facsimile, by email in “portable document format”
(“.pdf”), or by any other electronic means intended to preserve the original
graphic and pictorial appearance of this Agreement shall have the same effect as
physical delivery of the paper document bearing original signature.

[Signature Page Follows]

 

- 87 -

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

FINAL VERSION

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized officers effective as of the Amended and
Restated Effective Date.

 

OREXIGEN THERAPEUTICS, INC.

   

TAKEDA PHARMACEUTICAL COMPANY LIMITED

By:

 

/s/ Michael A. Narachi

   

By:

 

/s/ Christophe Weber

Name:

 

Michael A. Narachi

     

Name:

 

Christophe Weber

Title:

 

President & CEO

     

Title:

 

President & CEO

Date:

 

8/17/15

     

Date:

 

8/17/15

 

By:

 

/s/ Joseph P. Hagan

Name:

 

Joseph P. Hagan

Title:

 

EVP, Chief Business and Financial Officer

Date:

 

8/17/15

[Signature Page to Amended and Restated Collaboration Agreement]

 

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

Execution Version

Exhibit 1.98

Orexigen Logo

 

LOGO [g17979ex10_1pg089.jpg]

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

Exhibit 1.99

Orexigen Patents

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

Pat. or Pub. No.

  

Title

  

Date Filed

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

 

i

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

Pat. or Pub. No.

  

Title

  

Date Filed

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

  

[…***…]

[…***…]

[…***…]

[…***…]

 

ii

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

Exhibit 3.3.3

Commercialization Reports

 

REPORT

  

FREQUENCY OF REPORTING

  

[…***…]

  

[…***…]

  

[…***…]

  

[…***…]

[…***…]

  

[…***…]

        

[…***…]

  

[…***…]

        

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

     

[…***…]

        

[…***…]

  

[…***…]

        

[…***…]

  

[…***…]

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

Exhibit 3.5.3

Co-Promote Agreement Terms

The Co-Promote Agreement shall include the following terms and conditions:

1. Commercialization Rights; Co-Promote Activities. Orexigen shall be entitled
to participate in the Commercialization of Contrave in the Initial Indication in
the U.S. as follows: (i) through membership in the JCC pursuant to Section 5.3
of this Agreement; (ii) by performing a portion of the PDEs in the U.S., subject
to the applicable rights, obligations and limitations contained in Article 3 of
this Agreement (including, for the avoidance of doubt, Section 3.5.4 of this
Agreement (Change of Control of Orexigen)); and (iii) conducting such other
activities necessary to support its PDE obligation. The Co-Promote Agreement
shall be structured to reflect the following, subject in all events to the terms
of Section 3.5 of this Agreement:

 

 

•

 

The number of PDEs to be performed annually by the Parties shall be determined
by the JCC and set forth in the Commercialization Plan, within the limitations
and rights set forth in Sections 3.5.1 and 3.5.2 of this Agreement, taking into
consideration prescribing levels, geographic territory, centers of excellence,
target groups, detail position and other relevant considerations as the JCC may
determine;

 

 

•

 

Each Party shall provide its PDE requirements in the Commercialization Plan with
the goal of achieving the call plan, but in accordance with the following: (i)
during each […***…], at least […***…] percent ([…***…]%) of its PDE requirement
under the call plan; and (ii) during each […***…], at least […***…] percent
([…***…]%) of its PDE requirement under the call plan. If either Party fails to
achieve […***…] percent ([…***…]%) of its PDE requirement under the call plan in
a […***…], it must exceed […***…] percent ([…***…]%) of its PDE requirement
under such call plan in the following […***…] by the number of PDEs that such
Party failed to achieve in the prior […***…] (i.e., that caused it to achieve
less than […***…] percent ([…***…]%) of its PDE requirement under the call
plan). If either Party fails to achieve […***…] percent ([…***…]%) of its PDE
requirement under the call plan in any […***…], it must exceed […***…] percent
([…***…]%) of its PDE requirement under the call plan in the following […***…]
by the number of PDEs that such Party failed to achieve in the prior […***…]
(i.e., that caused it to achieve less then […***…] percent ([…***…]%) of its PDE
requirement under the call plan). Any failure by either Party to correct a PDE
shortfall (i.e., achieving less than […***…] percent ([…***…]%) of its PDE
requirement under the call plan in a […***…] or […***…] percent ([…***…]%) of
its PDE requirement under the call plan in a […***…]) in the timeframe specified
above shall be a material breach of the Co-Promote Agreement, and the
non-breaching Party shall have the remedies set forth in paragraph 7 of this
Exhibit 3.5.3; provided, for the avoidance of doubt, if a Party achieves the PDE
requirements set forth above, including through the correction of any shortfall,
it may not be held in material breach for failure to achieve […***…] percent
([…***…]%) of the PDE requirements under call plan within the Commercialization
Plan.

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

 

•

 

The Parties shall implement and maintain sales force incentive plans regarding
the promotion of the Product that ensure that the targeted incentive weighting
for each Sales Representative’s performance is commensurate with the PDE
requirement for each Sales Representative as determined in the call plan. For
example, a Sales Representative who is expected to deliver […***…] percent
([…***…]%) of his/her PDEs in support of the Product (with the remainder being
allocated to other products) shall have an incentive plan that ensures that
[…***…] percent ([…***…]%) of the targeted incentive within a specified time
period under the call plan is dependent upon performance of the Product. For the
avoidance of doubt: (i) the incentive weighting for the Product may, but does
not have to, equal or exceed […***…] percent ([…***…]%) of the overall incentive
weighting applied to both the Product and the other products, and (ii) the
incentive weighting for the Product is intended to […***…], and to achieve the
overall JCC approved call plan and contractual PDE requirements.

2. Commercialization Costs.

 

 

•

 

Except as otherwise specifically provided in this Exhibit 3.5.3, Orexigen shall
be responsible for […***…] costs and expenses relating to its Commercialization
activities under the Co-Promote Agreement, including […***…].

 

 

•

 

[…***…].

 

 

•

 

Orexigen’s Commercialization Costs shall not include […***…], and shall be
limited to (a) […***…] and (b) […***…]; provided, for the avoidance of doubt,
Takeda and Orexigen contemplate […***…].

 

 

•

 

During the Initial Co-Promote Period, Orexigen shall be entitled to receive the
PDE Cost, or […***…] Dollars ($[…***…]) per PDE. Takeda’s cost-per-PDE is
[…***…] Dollars ($[…***…]).

 

 

•

 

Following the end of each Calendar Quarter during the Initial Co-Promote Period,
but not the Secondary Co-Promote Period, Takeda shall reimburse Orexigen for
[…***…].

 

 

•

 

During the Initial Co-Promote Period, […***…] shall be applied toward Takeda’s
Commercialization Cost obligations pursuant to Section 3.2.3 of the Agreement.

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

3. PDE and Sample Reporting.

 

 

•

 

Each Party shall maintain complete and accurate records of each PDE performed by
its Sales Representatives using a call document, in a form agreed upon by the
Parties, which records the name and address of each target prescriber, the date
and position of the PDE, the number of samples delivered, and any other
information reasonably requested by Takeda.

 

 

•

 

Each Party shall provide the other Party with a monthly written report of the
number of total PDEs performed, including the position of the PDEs, in a form
agreed upon by the Parties. The monthly report shall be provided no later than
the […***…] calendar day of the following month, or within such timeframe as is
consistent with each Party’s then-current systems and processes for creating
such written reports.

 

 

•

 

Takeda shall determine sampling procedures to be followed by Orexigen, if
applicable, and will consider in good faith input from Orexigen.

 

 

•

 

During the term of the Co-Promote Agreement, and for a period of […***…]
([…***…]) years thereafter, Takeda shall have the right to perform audits of
Orexigen’s files, records, databases, and other information solely related to
the Product and as necessary to confirm the accuracy of any PDE or sample
reports provided by Orexigen to Takeda under the Co-Promote Agreement for any
period during the preceding […***…] ([…***…]) years. Takeda shall perform such
audits at reasonable times, upon […***…] ([…***…]) days prior written notice and
in no case more than […***…] ([…***…]) […***…] per Calendar Year and no more
than […***…] ([…***…]) […***…] for each Calendar Year.

4. Performance Standards.

 

 

•

 

The Parties shall use Commercially Reasonable Efforts to Commercialize the
Products and shall perform their Commercialization obligations in accordance
with this Agreement, the Co-Promote Agreement and the applicable
Commercialization Plan, including the specific diligence obligations of Takeda
pursuant to Section 3.2 of this Agreement.

 

 

•

 

The Parties shall comply with all laws, rules and regulations applicable to the
marketing, sale and promotion of pharmaceutical products, including the
statutes, regulations and written directives of the FDA, including the United
States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and
the regulations promulgated thereunder, the Prescription Drug Marketing Act, the
Federal Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the
statutes, regulations and written directives of Medicare, Medicaid and all other
health care programs, as defined in 42 U.S.C. §1320a-7b(f), the Health Insurance
Portability and Accountability Act of 1996, the Pharmaceutical Research and
Manufacturers of America Code on Interactions with Healthcare Professionals, the
American Medical Association: (i) Guidelines on Gifts to Physicians from
Industry, and (ii) Prescriber Data Restriction Program, each as may be

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

 

amended from time to time. Consistent with the “Compliance Program Guidance for
Pharmaceutical Manufacturers,” published by the Office of Inspector General,
U.S. Department of Health and Human Services, Orexigen agrees to maintain a
compliance program with respect to its promotional and sales activities relating
to the Products containing all of the elements described in such guidance
document. Upon either Party’s request, the other Party shall provide the
requesting Party with copies of its policies for such compliance programs.

5. Promotional Materials and Samples. Takeda shall provide to Orexigen
reasonable quantities of promotional materials (i.e., developed and approved by
Takeda), samples, or sample vouchers for Product to support Orexigen’s
Co-Promote activities in accordance with the following:

 

 

•

 

During the Initial Co-Promote Period, Takeda shall provide such promotional
materials, samples or sample vouchers to Orexigen […***…];

 

 

•

 

During the Secondary Co-Promote Period, Takeda shall provide such promotional
materials to Orexigen […***…] with samples or sample vouchers being provided to
Orexigen […***…]; and

 

 

•

 

During the Initial Co-Promote Period and Secondary Co-Promote Period, Orexigen
shall not, and shall ensure that its Sales Representatives do not, make any
changes to the promotional materials.

6. Training and Related Sales Force Issues.

 

 

•

 

During the Initial Co-Promote Period and prior to launch of the Product, Takeda
shall […***…]: (i) provide training to Orexigen’s sales managers and trainers
(i.e., train-the-trainer), and (ii) ship training materials to Orexigen as
reasonably required for Orexigen’s training activities.

 

 

•

 

During the Initial Co-Promote Period and after launch of the Product, Orexigen
shall be responsible for: (i) conducting training for its sales managers and
trainers […***…], and (ii) […***…] shipment of training and promotional
materials to Orexigen.

 

 

•

 

Except as set forth above in this paragraph 6, during the Initial Co-Promote
Period and the Secondary Co-Promote Period, Orexigen shall be responsible,
[…***…], for training, supervising and maintaining its sales force, including as
is necessary for launch of the Product.

7. Term and Termination.

 

 

•

 

Except as set forth below in this paragraph 7, the term of the Co-Promote
Agreement shall commence on the effective date of the Co-Promote activities and
shall continue in effect until expiration or termination of this Agreement,
unless otherwise terminated as set forth below.

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

 

•

 

The Co-Promote Agreement shall contain reasonable and appropriate termination
rights, including the following: (i) during the Initial Co-Promote Period,
Orexigen may terminate upon […***…] ([…***…]) […***…] prior written notice to
Takeda; (ii) during the Secondary Co-Promote Period, Orexigen may terminate upon
[…***…] ([…***…]) […***…] prior written notice to Takeda; and (iii) upon
termination for material breach, the non-breaching Party shall have the rights
and remedies set forth in Article 12 of this Agreement.

8. Medical Inquires. Takeda shall be responsible for and shall establish
procedures for handling any medical inquires from health care professionals or
others and any requests for medical information about the Product. Orexigen
shall follow such procedures to the extent applicable to its Commercialization
activities.

9. Adverse Events. The Parties shall establish a process for communicating and
reporting any adverse events and complaints relating to the Products in
accordance with the Pharmacovigilance Agreement described in Section 3.6 of this
Agreement.

10. Non-Solicitation. During the term of the Co-Promote Agreement and for
[…***…] ([…***…]) […***…] thereafter, neither Party shall actively recruit or
solicit, directly or through a Third Party, for employment any then-current
Sales Representative or associated field support of the other Party without the
written consent of the other Party. Nothing in this Agreement shall limit a
Party from engaging in general recruitment through advertisements or recruiting
through “head-hunters” so long as the Sales Representatives or associated field
support of the other Party are not specifically targeted in such recruitment
effort.

11. Additional Terms and Conditions. The Co-Promote Agreement shall contain such
other terms and conditions as are customarily contained in similar agreements in
the pharmaceutical industry; provided that, with respect to provisions also set
forth in this Agreement, the Parties shall endeavor to incorporate such
provisions in the Co-Promote Agreement (e.g., insurance, indemnification,
representations, recalls). In the event of any conflict between the Co-Promote
Agreement and this Agreement, the terms of this Agreement shall govern.

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

Exhibit 3.8.1

Product Trademarks

Registered Marks

CONTRAVE® (Class 5)

Pending Marks

CONTRAVE™ (Classes 16, 44)

LOGO [g17979ex10_1pg099.jpg] (Classes 5, 16, 44)

(The approved color for the CONTRAVE Logo is […***…])

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

Exhibit 8.2.12

Agreements

Reference is made to the following types of agreements that Orexigen has entered
into prior to the Original Effective Date in connection with the Products:

[…***…]

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

Exhibit 10.8

Press Release

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

Exhibit 13.3

Dispute Resolution

All references to “days” in this ADR provision are to calendar days.

 

1.

To begin an ADR proceeding, a Party shall provide written notice to the other
Party of the issues to be resolved by ADR. Within […***…] ([…***…]) days after
its receipt of such notice, the other Party may, by written notice to the Party
initiating the ADR, add additional issues to be resolved within the same ADR.

 

2.

Within […***…] ([…***…]) days following receipt of the original ADR notice, the
Parties shall select a mutually acceptable panel of […***…] ([…***…]) neutrals
to preside in the resolution of any disputes in this ADR proceeding. If the
Parties are unable to agree on a mutually acceptable panel of […***…] ([…***…])
neutrals within such period, either Party may request the President of the
International Institute for Conflict Prevention and Resolution (“CPR”), 575
Lexington Avenue, 21st floor New York, New York 10022, to select a panel of
[…***…] ([…***…]) neutrals pursuant to the following procedures:

 

 

(a)

The CPR shall submit to the Parties a list of not less than […***…] ([…***…])
candidates within […***…] ([…***…]) days after receipt of the request, along
with a Curriculum Vitae for each candidate. No candidate shall be an employee,
director, or shareholder of either Party or any of their Affiliates.

 

 

(b)

Such list shall include a statement of disclosure by each candidate of any
circumstances likely to affect his or her impartiality.

 

 

(c)

Each Party shall number the candidates in order of preference (with the number
one (1) signifying the greatest preference) and shall deliver the list to the
CPR within […***…] ([…***…]) days following receipt of the list of candidates.
If a Party believes a conflict of interest exists regarding any of the
candidates, that Party shall provide a written explanation of the conflict to
the CPR along with its list showing its order of preference for the candidates.
Any Party failing to return a list of preferences on time shall be deemed to
have no order of preference.

 

 

(d)

If the Parties collectively have identified fewer than […***…] ([…***…])
candidates deemed to have conflicts, the CPR immediately shall designate as the
panel of […***…] ([…***…]) neutrals the three candidates for whom the Parties
collectively have indicated the greatest preference. If a tie should result
between two candidates, the CPR may designate either candidate. If the Parties
collectively have identified […***…] ([…***…]) or more candidates deemed to have
conflicts, the CPR shall review the explanations regarding conflicts and, in its
sole discretion, may either (i) immediately designate as the neutral the
candidate for whom the Parties collectively have indicated the

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

  greatest preference, or (ii) issue a new list of not less than […***…]
([…***…]) candidates, in which case the procedures set forth in subparagraphs
2(a) - 2(d) shall be repeated.

 

3.

No earlier than […***…] ([…***…]) days or later than […***…] ([…***…]) days
after selection, the panel shall hold a hearing to resolve each of the issues
identified by the Parties. The ADR proceeding shall take place at a location
agreed upon by the Parties. If the Parties cannot agree, the panel shall
designate a location other than the principal place of business of either Party
or any of their Affiliates. Commencing on the date […***…] ([…***…]) days after
receipt of the initial ADR notice described in paragraph 1 above, the Parties
shall be entitled to engage in reasonable discovery under procedures of the
Federal Rules of Civil Procedure; provided, however, that a party may not take
more than […***…] ([…***…]) depositions. There shall not be any, and the panel
shall not permit any, discovery within […***…] ([…***…]) […***…] of the hearing.
The panel shall decide any Disputes between the Parties related to discovery,
including ruling on reasonable requests to expedite discovery, taking into
account the applicable period of time for discovery.

 

4.

At least […***…] ([…***…]) days prior to the hearing, each Party shall submit
the following to the other Party and the panel:

 

 

(a)

a copy of all exhibits on which such Party intends to rely in any oral or
written presentation to the panel;

 

 

(b)

a list of any witnesses such Party intends to call at the hearing, and a short
summary of the anticipated testimony of each witness;

 

 

(c)

a proposed ruling on each issue to be resolved, together with a request for a
specific damage award or other remedy for each issue. The proposed rulings and
remedies shall not contain any recitation of the facts or any legal arguments
and shall not exceed […***…] ([…***…]) page per issue.

 

 

(d)

a brief in support of such Party’s proposed rulings and remedies, provided that
the brief shall not exceed […***…] ([…***…]) pages. This page limitation shall
apply regardless of the number of issues raised in the ADR proceeding.

 

5.

The hearing shall be conducted on […***…] ([…***…]) consecutive days and shall
be governed by the following rules:

 

 

(a)

Each Party shall be entitled to […***…] ([…***…]) hours of hearing time to
present its case. The panel shall determine whether each Party has had the
[…***…] ([…***…]) hours to which it is entitled.

 

 

(b)

Each Party shall be entitled, but not required, to make an opening statement, to
present regular and rebuttal testimony, documents or other evidence, to
cross-examine witnesses, and to make a closing argument. Cross-examination of
witnesses shall occur immediately after their direct testimony, and
cross-examination time shall be charged against the Party conducting the
cross-examination.

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

 

(c)

The Party initiating the ADR shall begin the hearing and, if it chooses to make
an opening statement, shall address not only issues it raised but also any
issues raised by the responding Party. The responding Party, if it chooses to
make an opening statement, also shall address all issues raised in the ADR.
Thereafter, the presentation of regular and rebuttal testimony and documents,
other evidence, and closing arguments shall proceed in the same sequence.

 

 

(d)

Except when testifying, witnesses shall be excluded from the hearing until
closing arguments.

 

 

(e)

Settlement negotiations, including any statements made therein, shall not be
admissible under any circumstances. Affidavits prepared for purposes of the ADR
hearing also shall not be admissible. As to all other matters, the panel shall
have sole discretion regarding the admissibility of any evidence.

 

6.

Within […***…] ([…***…]) days following completion of the hearing, each Party
may submit to the other Party and the panel a post-hearing brief in support of
its proposed rulings and remedies, provided that such brief shall not contain or
discuss any new evidence and shall not exceed […***…] ([…***…]) pages. This page
limitation shall apply regardless of the number of issues raised in the ADR
proceeding.

 

7.

The panel shall rule on each disputed issue in writing within […***…] ([…***…])
days following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the Parties on each disputed
issue but may adopt one Party’s proposed rulings and remedies on some issues and
the other Party’s proposed rulings and remedies on other issues. The panel shall
not issue any written opinion or otherwise explain the basis of the ruling.

 

8.

The panel shall be paid a reasonable fee plus expenses. These fees and expenses,
along with the […***…], shall be paid as follows:

 

 

(a)

If the panel rules in favor of one Party on all disputed issues in the ADR, the
losing Party shall pay […***…]% of such reasonable fees and expenses.

 

 

(b)

If the panel rules in favor of one Party on some issues and the other Party on
other issues, the panel shall issue with the rulings a written determination as
to how such fees and expenses shall be allocated between the Parties. The panel
shall allocate fees and expenses in a way that bears a reasonable relationship
to the outcome of the ADR, with the Party prevailing on more issues, or on
issues of greater value or gravity, recovering a relatively larger share of its
legal fees and expenses.

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

9.

The arbitration shall be governed by the Federal Arbitration Act, 9 U.S.C. §§ 1
et seq., and judgment upon the award rendered by the arbitrators may be entered
by any court having jurisdiction thereof.

 

10.

Except as provided in paragraph 9 or as required by law, the existence of the
Dispute, any settlement negotiations, the ADR hearing, any submissions
(including exhibits, testimony, proposed rulings, and briefs), and the rulings
shall be deemed Confidential Information as set forth in Section 13.7 of this
Agreement. The panel shall have the authority to impose sanctions for
unauthorized disclosure of Confidential Information.