Exhibit 10.1

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

MANUFACTURING SERVICES AGREEMENT

This MANUFACTURING SERVICES AGREEMENT (the “Agreement”) is made and entered into
as of September 2, 2014 (the “Effective Date”) by and between Orexigen
Therapeutics, Inc., a Delaware corporation with its principal place of business
at 3344 N. Torrey Pines Court, Suite 200, La Jolla, California 92037, United
States of America (“Orexigen”), and Takeda Pharmaceutical Company Limited, a
company incorporated under the laws of Japan, with its 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, the Parties have entered into that certain Collaboration Agreement,
dated September 1, 2010, as amended by Amendment Number 1 to Collaboration
Agreement effective as of September 26, 2013 (collectively, the “Collaboration
Agreement”), pursuant to which Orexigen has granted Takeda certain rights to
Develop, Manufacture and Commercialize the Product in the Territory; and

WHEREAS, pursuant to Article 4 of the Collaboration Agreement, Orexigen has
agreed to manufacture and supply to Takeda, and Takeda has agreed to purchase
from Orexigen, all of Takeda’s, its Affiliates’ or permitted Sublicensees’
requirements for Commercialization of the Product (other than Commercial
Packaging) in the Territory until such time, if ever, that Takeda assumes
responsibility for the manufacture and supply of the Product, including pursuant
to Section 3.6.1 of this Agreement or Section 4.2 of the Collaboration
Agreement.

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

ARTICLE 1

DEFINITIONS

Capitalized terms used herein and not defined below shall have the respective
meanings assigned to such terms in the Collaboration Agreement; if a term is
defined in this Agreement in a manner which differs from its definition in the
Collaboration Agreement, for purposes of this Agreement, the definition
contained in this Agreement shall govern.

1.1 “Actual Annual Yield” has the meaning set forth for such term in the Patheon
Agreement, or shall have such other meaning as agreed to in writing by the
Parties.

1.2 “Batch” means a specific quantity of the Product (consisting of a number of
tablets based on demonstrated Actual Annual Yield), that is intended to have
uniform character and quality, within specified limits, and is produced
according to a single manufacturing order.

 

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1.3 “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 Effective Date to the end of the first Calendar Quarter thereafter; and
(b) the last Calendar Quarter of the Term shall end upon the effective date of
expiration or termination of this Agreement.

1.4 “Calendar Year” means (a) for the first Calendar Year of the Term, the
period beginning on the Effective Date and ending on December 31, 2014, (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.

1.5 “Capacity Percentage” means [***] percent ([***]%), or such other percentage
as agreed to in writing by the Parties.

1.6 “cGMPs” means the applicable current good manufacturing practices as
described in Parts 210 and 211 of Title 21 of the United States Code of Federal
Regulations, together with the latest FDA guidance documents pertaining to
manufacturing and quality control practice (including the FDA’s Guidance for
Industry, Manufacturing, Processing, or Holding Active Pharmaceutical
Ingredients), all as updated, amended and revised from time to time, and, as
applicable, any similar or equivalent regulations and requirements in
jurisdictions outside the U.S.

1.7 “Commercially Reasonable Efforts” means, with respect to the efforts to be
expended, or considerations to be undertaken, by a Party and/or its Affiliates
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.

1.8 “Contrave” means the Orexigen proprietary formulation of bupropion
hydrochloride and naltrexone hydrochloride, formulated in a sustained release
formulation, as described in the NDA No. 20-0063. For clarity, Contrave may be
used for clinical development or commercial purposes.

1.9 “Delivery of Launch Supplies” means Launch Supplies are available and at the
disposal of Takeda at Orexigen packaging site not later than the Launch Supplies
Delivery Date.

1.10 “Effective Date” has the meaning set forth in the first paragraph of this
Agreement.

1.11 “Facility Consulting Support” means services that are primarily provided
on-site at a Third Party Manufacturer by a Third Party consultant who has
special knowledge, skill and/or expertise relating to a particular field, job or
area of [***], and the like; provided, further, such services are intended to
include activities and responsibilities that would not otherwise be provided by
personnel of Orexigen or Takeda in their respective normal course of business.

 

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1.12 “Firm Order” has the meaning set forth in Section 3.2.

1.13 “Forecast” has the meaning set forth in Section 3.1.1.

1.14 “Initial Month” has the meaning set forth in Section 3.1.1.

1.15 “Knowledge” means, as applied to a Party in this Agreement, that such Party
shall be deemed to have knowledge of a particular fact or other matter to the
extent that a reasonably prudent person with experience in or with the
pharmaceutical industry and with primary responsibility for the applicable
subject matter would know of such fact or other matter upon reasonably diligent
inquiry.

1.16 “Launch Supplies” means the full quantity of Product in finished bulk form
[***], by dosage strength, ordered by Takeda for commercial launch of Product in
the U.S., 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 this
Agreement.

1.17 “Launch Supplies Delivery Date” means the delivery date specified in
Takeda’s Firm Order for Launch Supplies issued to Orexigen at least [***] prior
to such delivery date; provided, however, that if any delay in Delivery of
Launch Supplies, is caused by Takeda, then such delivery date shall be extended
for each day such delivery may be delayed.

1.18 “Manufacturing Capacity” means the Capacity Percentage multiplied by the
annual manufacturing capacity [***] ([***] of the Product) over the course of
the applicable rolling twelve (12) month period.

1.19 “Manufacturing Payments” means Obsolete Material Costs, Period Costs, and
the Transfer Price payable by Takeda pursuant to this Agreement.

1.20 “Obsolete Material Costs” means the costs of materials, including [***].
For the avoidance of doubt, Obsolete Material Costs shall not include [***].
Obsolete Material Costs shall be accounted for in accordance with GAAP or IFRS,
as applicable.

1.21 “Patheon” means, collectively, Patheon Pharmaceuticals Inc. and Patheon
Inc.

1.22 “Patheon Agreement” means the Manufacturing Services Agreement dated
March 12, 2010 between Orexigen and Patheon, as it may be amended from time to
time.

1.23 “Period Costs” means the costs, [***]. For the avoidance of doubt, Period
Costs shall not include [***]. Period Costs shall be accounted for in accordance
with GAAP or IFRS, as applicable.

 

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1.24 “Pharmacovigilance Agreement” means an agreement entered into between the
Parties concerning matters relating to the management and exchange of safety
information as described in Section 3.6 of the Collaboration Agreement.

1.25 “Product” means the Orexigen proprietary formulation of bupropion
hydrochloride and naltrexone hydrochloride, formulated in a sustained release
formulation, as described in NDA No. 200063, [***] for commercial sale, solely
in one or more of the forms set forth in Exhibit 1.25, as such Exhibit may be
supplemented or amended from time to time in upon mutual written agreement of
the Parties in accordance with Section 7.3.3.

1.26 “Quality Agreement” has the meaning set forth in Section 9.1.

1.27 “Recall” means any product recall, field correction, or withdrawal of the
Product in the Territory.

1.28 “Recall Costs” has the meaning set forth in Section 10.2.

1.29 “Safety Stock” means inventory of Licensed Compounds, excipients,
laboratory supplies, and the Product deemed necessary by the JMC for the
Territory to be maintained in order to manage demand or supply risks associated
with the Product in the Territory.

1.30 “[***]” means [***].

1.31 “Specifications” means the formulations, manufacturing directions,
packaging specifications, testing methods, sampling instructions, quality
control procedures and finished product specifications, as amended from time to
time in accordance with Section 7.3. The Specifications in effect as of the
Effective Date are attached as Exhibit 1.31.

1.32 “Takeda Damages” has the meaning set forth in Section 3.6.3.

1.33 “Term” has the meaning set forth in Section 13.1.

1.34 “Third Party Manufacturer” has the meaning set forth in Section 2.3.1.

1.35 “Third Party Manufacturer Agreements” means those agreements set forth in
Exhibit 2.3.1, as such Exhibit may be revised from time to time as set forth in
Section 2.3.

1.36 “Three Year Forecast” has the meaning set forth in Section 3.1.2.

1.37 “Transfer Price” means the [***] costs associated with the Manufacture of
the Product [***]. The Transfer Price will not include any (a) Period Costs,
(b) Obsolete Material Costs, (c) [***], (d) [***], or (e) [***]. The Transfer
Price shall be accounted for in accordance with GAAP or IFRS, as applicable.

 

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ARTICLE 2

PRODUCT MANUFACTURE AND SUPPLY

2.1 Purchase and Supply. Subject to the provisions of this Agreement and the
Collaboration Agreement, Orexigen shall Manufacture or have Manufactured, and
supply or have supplied, and Takeda shall purchase from Orexigen, all of
Takeda’s requirements of the Product for Commercialization of the Product in the
Territory, in accordance with the terms and conditions of this Agreement.
Without limiting Orexigen’s obligations hereunder, Orexigen shall use
Commercially Reasonable Efforts to meet Takeda’s requirements for the Product in
the Territory. Unless and until Manufacture of the Product is transferred to
Takeda, including pursuant to Section 3.6.1 of this Agreement or Section 4.2 of
the Collaboration Agreement, and except as otherwise set forth in Section 4.4 of
the Collaboration Agreement, Orexigen shall retain and have the sole and
exclusive right and obligation to Manufacture, have Manufactured, supply or have
supplied all of Takeda’s requirements of the Product for Commercialization in
the Territory itself or through its Third Party Manufacturers during the Term.
For clarity, Takeda shall be responsible for performing Commercial Packaging in
the Territory in accordance with Section 4.4 of the Collaboration Agreement.

2.2 Manufacturing Capacity. As part of the forecasting process under
Section 3.1, the Parties will cooperate to provide for the supply of Takeda’s
requirements of the Product hereunder. Takeda acknowledges that Orexigen shall
have satisfied its supply obligations under this Agreement if Orexigen has
supplied to Takeda, under this Agreement and any agreement between the Parties
and/or their Affiliates for supply of Contrave for Development, (a) [***], or
(b) [***], in each case of (a) and (b) [***]. By way of example, if the
Manufacturing Capacity is equal to [***], Takeda shall be entitled to forecast,
and Orexigen shall be obligated to supply, [***], Takeda shall also be entitled
to forecast, and Orexigen will supply to Takeda, [***]. Any Manufacturing
Capacity not used by Takeda during the [***]. For example, if Takeda does not
[***]. Conversely, if, for example, Takeda [***].

2.3 Third Party Manufacturers.

2.3.1 Orexigen Subcontracting. Orexigen may subcontract any or all of its
obligations pursuant to this Agreement to any or all of the Third Party
manufacturers set forth in Exhibit 2.3.1, as such Exhibit may be revised from
time to time as set forth in Section 2.3.2 or 2.3.3 (the “Third Party
Manufacturers”). For purposes of this Section 2.3, the term “manufacturer” is
considered to be inclusive of all facilities designated in the corresponding
section of the NDA. These include, but are not limited to, testing laboratories
and packaging facilities. Orexigen acknowledges that it has entered into Third
Party Manufacturer Agreements with the Third Party Manufacturers set forth in
Exhibit 2.3.1, and, unless otherwise specified in Exhibit 2.3.1, such Third
Party Manufacturers shall undertake the Manufacture of the Product or active
pharmaceutical ingredients contained in the Product for a period of at least
[***] ([***]) years after First Commercial Sale. Orexigen shall be responsible
for the day-to-day management of all Third Party Manufacturer relationships
until such time, if ever, responsibility for Manufacturing is transferred to
Takeda, including pursuant to Section 3.6.1 of this Agreement or Section 4.2 of
the Collaboration Agreement.

 

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2.3.2 Amendments to Third Party Manufacturer Agreements. Orexigen shall not
amend any Third Party Manufacturer Agreement in any manner that could have a
material impact on the Manufacture of the Product for Takeda under this
Agreement or Takeda’s ability to Commercialize or Develop the Product in the
Territory without Takeda’s prior written consent, which consent shall not be
unreasonably withheld, conditioned, or delayed. Orexigen shall provide Takeda
with a copy of each amendment to a Third Party Manufacturer Agreement promptly
after its execution, and shall update Exhibit 2.3.1 to reflect such amendment.

2.3.3 Takeda Consent to Third Party Manufacturer Agreements. Takeda hereby
consents to the Manufacture of the Product by the Third Party Manufacturers
listed in Exhibit 2.3.1 as of the Effective Date. Orexigen shall be required to
seek Takeda’s prior written consent before subcontracting any or all of its
obligations pursuant to this Agreement to a Third Party manufacturer that is not
listed in Exhibit 2.3.1, which consent shall not be unreasonably withheld,
conditioned, or delayed.

2.3.4 Maintenance of Third Party Manufacturer Agreements. Orexigen agrees that
it shall use Commercially Reasonable Efforts to maintain the Third Party
Manufacturer Agreements in force and effect as required to satisfy its supply
obligations under this Agreement unless otherwise mutually agreed to in writing
by the Parties.

2.4 Inventions and Intellectual Property. Ownership of any and all inventions
conceived or reduced to practice solely by a Party or such Party’s employees,
consultants, or contractors (including Third Party Manufacturers) or jointly by
the Parties or the Parties’ employees, consultants or contractors (including
Third Party Manufacturers) in the course of activities performed under or
contemplated by this Agreement, any and all intellectual property rights
therein, and any and all patent applications and patents resulting therefrom
shall be subject to the provisions of Sections 9.1 to 9.5 of the Collaboration
Agreement.

ARTICLE 3

FORECASTING AND ORDERING

3.1 Forecasts.

3.1.1 Twelve-Month Forecasts. At least [***] ([***]) months prior to the first
day of the month in which Takeda requests initial delivery of the Product (such
month, the “Initial Month”), Takeda shall provide Orexigen with a twelve
(12) month rolling forecast for the quantity of the Product to be delivered in
each month of the twelve (12) month rolling forecast (each, a “Forecast”), with
the first such forecast beginning with the quantity of Batches of the Product
that Takeda expects to be delivered beginning with the Initial Month. No later
than the [***] thereafter, Takeda will provide Orexigen with an updated
Forecast. On a monthly basis, the Parties will review the Forecast for months
[***] ([***]) through [***] ([***]) and use Commercially Reasonable Efforts to
(i) [***], or (ii) [***]. Subject to Sections 2.2 and 3.5, the

 

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quantity of the Product provided for in the first [***] ([***]) months of each
revised Forecast will be binding on each of the Parties, such that Takeda will
be obligated to purchase, and Orexigen will be obligated to supply, the quantity
of the Product forecasted for delivery in such months. The most recent revised
Forecast will prevail over all previous Forecasts.

3.1.2 Three Year Forecasts. At least [***] ([***]) months prior to the Initial
Month, Takeda shall provide Orexigen with a written three (3) year forecast (of
which the first year shall consist of the Forecast provided under Section 3.1.1,
and the second and third years of this three (3) year forecast shall be broken
down by Calendar Quarters) of the quantity of Batches of the Product Takeda then
anticipates it will require to be delivered to Takeda during the three (3) year
period, which forecast shall be non-binding except for the first [***] ([***])
months covered by such forecast, and shall be used by Orexigen for planning
purposes (the “Three Year Forecast”). In addition, on or before the [***] of
each [***], Takeda will provide Orexigen with an updated rolling Three Year
Forecast.

3.2 Firm Orders. Subject to Sections 2.2 and 3.5, Takeda shall issue binding
written orders in the form of original (i.e., not copies) purchase orders to
purchase Batches of the Product under this Agreement (“Firm Orders”), each of
which shall specify the type and quantity of Batches of the Product to be
delivered and the requested delivery date. For clarity, Takeda is required to
order the Product in full Batches, unless otherwise mutually agreed to in
writing. Takeda shall submit a Firm Order to Orexigen at least [***] ([***])
months prior to the delivery date indicated in such Firm Order. Unless otherwise
mutually agreed to by the Parties, [***]. Any term or condition in a Firm Order,
confirmation, or other document furnished by a Party that is inconsistent with
the terms and conditions of this Agreement will not be binding on the Parties.
For Launch Supplies, Takeda will issue a Firm Order at least [***] ([***])
months prior to the Launch Supplies Delivery Date, and Orexigen may invoice the
estimated Transfer Price when Orexigen completes Delivery of Launch Supplies.

3.3 Order Confirmation. Within [***] ([***]) days after receipt of Takeda’s Firm
Order, Orexigen shall confirm or decline the Firm Order in writing; provided,
however, that Orexigen may decline a Firm Order only with respect to quantities
of the Product in excess of those set forth in the binding portion of the
Forecast for the relevant period. [***]. For clarity, Orexigen shall use
Commercially Reasonable Efforts to supply quantities of the Product requested by
Takeda that are in excess of those set forth in the binding portion of the
Forecast for the relevant period. All Firm Orders confirmed by Orexigen will be
binding and may not be cancelled or modified by either Party without the other
Party’s written consent. For clarity, if Takeda cancels a Firm Order, Takeda is
obligated to pay to Orexigen only the direct Third Party costs incurred by
Orexigen and its Third Party Manufacturers in connection with the Product that
is subject to such cancellation.

3.4 Delivery of Launch Supplies. Notwithstanding anything to the contrary
contained in this Agreement, in order to achieve Delivery of Launch Supplies,
Orexigen shall deliver the Launch Supplies to Takeda by the Launch Supplies
Delivery Date. If Orexigen fails to achieve Delivery of Launch Supplies by the
Launch Supplies Delivery Date, then Takeda will have solely the remedies set
forth in Section 3.6.1(a) and (b) and the following remedy: Takeda shall not be
obligated to pay the Ten Million Dollar ($10,000,000) second milestone event
payment under the heading “Development Milestones” set forth in Section 7.2.1 of
the Collaboration Agreement and Orexigen shall forfeit receipt of such payment.

 

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3.5 Allocation of Supply. If Orexigen is unable, using Commercially Reasonable
Efforts, to supply Takeda’s requirements of the Product for the Territory as set
forth in Takeda’s binding Firm Orders, then, unless otherwise agreed in writing
by the Parties, for as long as the shortage shall last, Takeda shall receive
[***].

3.6 Remedies for Failure to Supply.

3.6.1 Takeda Assumption of Manufacturing Responsibilities. Subject to
Section 3.6.2, upon the occurrence of any of the following events during the
Term, whether the first occurrence or any subsequent occurrence thereof, Takeda
may, at its election made in writing to Orexigen, and subject to the provisions
of Section 14.1 of the Collaboration Agreement and a mutually agreed upon
transition plan, (a) [***], and/or (b) [***]:

(i) Orexigen fails to achieve Delivery of Launch Supplies by the Launch Supplies
Delivery Date;

(ii) Orexigen fails to deliver the Product, other than Launch Supplies as
addressed in Section 3.6.1(i), within [***] ([***]) Business Days after the
specified delivery date set forth in any Firm Order submitted in accordance with
Section 3.2 and confirmed by Orexigen in accordance with Section 3.3;

(iii) Orexigen fails to deliver in any [***] at least [***] percent ([***]%) of
the Batches of the Product ordered by Takeda in a Firm Order submitted in
accordance with Section 3.2 and confirmed by Orexigen in accordance with
Section 3.3; or

(iv) Orexigen or any of its Affiliates 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 such Person or of substantially all of its assets, or if such Person is
served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days
after the filing thereof, or if such Person shall propose or be a party to any
dissolution or liquidation, or if such Person shall make an assignment of
substantially all of its assets for the benefit of creditors.

3.6.2 Unexpected Increase in Demand for Product. Takeda’s remedies under
Section 3.6.1 will not apply if a failure by Orexigen under Section 3.6.1(i),
(ii), or (iii) is caused by an unexpected increase in Takeda’s demand for the
Product in the Territory, including Firm Orders for the Product, that exceeds
(i) Orexigen’s ability to obtain additional supply of Licensed Compounds and the
Product necessary to meet such demand after using available Safety Stock for the
Territory, (ii) Patheon’s obligation to supply the Product to Orexigen under the
Patheon Agreement, and/or (iii) the Manufacturing Capacity.

 

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3.6.3 Recovery of Takeda Damages. Orexigen shall [***]. For the avoidance of
doubt [***].

3.7 Exclusive Remedies. EXCEPT AS SET FORTH IN ARTICLES 8, 10, AND 12, TAKEDA’S
SOLE REMEDY FOR ANY FAILURE BY OREXIGEN TO ACHIEVE DELIVERY OF LAUNCH SUPPLIES
AND/OR SUPPLY THE PRODUCT IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT SHALL
BE THE REMEDIES SET FORTH IN SECTIONS 3.4 (AS APPLICABLE), 3.5, 3.6.1(a) AND
(b), AND 3.6.3 (AS APPLICABLE). For clarity, except for termination of this
Agreement pursuant to Section 13.2 as a consequence of Takeda’s exercise of its
rights under Section 4.2 of the Collaboration Agreement or pursuant to
Section 3.6.1 of this Agreement, Takeda shall not have the right to terminate
this Agreement or the Collaboration Agreement for Orexigen’s failure to achieve
Delivery of Launch Supplies as set forth in Section 3.4, or for any other
failure by Orexigen to supply the Product in accordance with this Agreement.

ARTICLE 4

JMC; CAPACITY EXPANSION; EXPENDITURES;

COST IMPROVEMENTS; QUALITY IMPROVEMENTS

4.1 JMC. The JMC shall have [***] over the Manufacture and distribution of the
Product under this Agreement during the Term. The JMC shall [***] developments
relating to forecasting, commercial and regulatory issues, scheduling and
supply, projects relating to capacity expansion, capital and/or operating
expenditures, quality improvements and cost improvements, and other matters
related to Manufacturing under this Agreement. In addition, the JMC shall [***]
the appropriate level and management of Safety Stock. During the Term, and
[***], Orexigen shall retain final decision-making authority with respect to
Manufacturing as set forth in Section 5.7.3(b)(ii) of the Collaboration
Agreement until and unless Takeda assumes responsibility for Manufacturing
pursuant to Section 3.6.1 of this Agreement or [***], upon which Takeda will
have final decision-making authority as set forth in Section 5.7.3(a)(iv) of the
Collaboration Agreement. For the avoidance of doubt, such final decision-making
authority does not include any right to make any decision with respect to any
disputes between the Parties as to the meaning of any provision of this
Agreement or the Collaboration Agreement or either Party’s performance under
this Agreement or the Collaboration Agreement or lack thereof.

 

4.2 Capacity Expansion.

4.2.1 At its option, and at any time during the Term, either Party may seek to
invest in additional manufacturing capacity for the Manufacture of the Product.
In such event, such Party will provide written notification to the other Party
of its intent, which notice shall include all information reasonably necessary
for such other Party to understand the additional capacity sought (i.e., the
number of tablets of the Product), and the expected timing for receipt of such
additional capacity. Upon receipt of the notice from such other Party, the other
Party (i.e., the Party that received the notice) agrees to negotiate in good
faith with such other Party supply of Product to or from such other Party using
such additional manufacturing capacity and associated

 

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pricing. At Takeda’s request, [***]. Notwithstanding anything to the contrary in
this Section 4.2.1, Orexigen shall have no obligation to establish a second
Manufacturing facility or to increase the capacity at Patheon’s Manufacturing
facility for the Product during the Term.

4.2.2 If a Party desires a commitment of Manufacturing capacity at Patheon’s
Manufacturing facility beyond the Manufacturing Capacity, or desires that an
additional Manufacturing facility other than at [***] be established by Orexigen
for the Manufacture of the Product during the Term, such Party shall present to
the JMC for consideration the proposed project, expected results, estimated
costs thereof, how the additional capacity from such project will be allocated
between the Territory and outside the Territory, and how the costs of such
project will be borne between the Parties. If the JMC does not approve a project
and such cost sharing, either Party may escalate the Dispute pursuant to
Section 5.7 of the Collaboration Agreement; provided, however, that [***] shall
have final decision-making authority or the right to solely decide a Dispute
related to a project for capacity expansion pursuant to this Section 4.2. For
any capacity expansion project solely for the Territory that is approved by the
JMC (or pursuant to Section 5.7 of the Collaboration Agreement), the costs shall
be borne [***]. For any other capacity expansion project and cost sharing that
is approved by the JMC (or pursuant to Section 5.7 of the Collaboration
Agreement), the costs of such project will be borne [***] (or pursuant to
Section 5.7 of the Collaboration Agreement). Notwithstanding the foregoing,
Orexigen may incur costs for capacity expansion projects solely for the
manufacture of the Product for use outside of the Territory in its sole
discretion and at its sole cost and benefit.

4.3 Capital and Operating Expenditures. The Parties agree that as of the
Effective Date (as such term is defined in the Collaboration Agreement), no new
capital expenditures, including equipment, are required by Orexigen or its Third
Party Manufacturers to Manufacture the anticipated commercial demand for the
Product for the Territory. Notwithstanding anything to the contrary in this
Section 4.3, Orexigen shall have the right, in its sole discretion, to invest in
and implement one or more capital and/or operating expenditure projects that are
reasonably deemed by Orexigen to be necessary in order to meet its obligations
under this Agreement; provided, that (i) the aggregate cost of such expenditure
project(s) (including purchase and implementation costs) in a Calendar Year does
not exceed [***] Dollars ($[***]), and (ii) all costs relating to any such
expenditure project(s) (including purchase and implementation costs) that do not
exceed [***] Dollars ($[***]) in a Calendar Year shall be Period Costs and
treated/allocated in accordance with Section 5.3.1. In the event that a Party
desires to invest in one or more expenditure projects that will result in the
aggregate cost of one or more expenditure projects exceeding [***] Dollars
($[***]) in a Calendar Year, such Party shall present the proposed project,
expected results and estimated costs thereof to the JMC for consideration. If
the JMC does not approve such expenditure project, either Party may escalate the
Dispute pursuant to Section 5.7 of the Collaboration Agreement; provided,
however, that [***] shall have final decision-making authority or the right to
solely decide a Dispute related to such expenditure project. For such an
expenditure project that is approved by the JMC (or pursuant to Section 5.7 of
the Collaboration Agreement), the costs shall be Period Costs and
treated/allocated in accordance with Section 5.3.1,

 

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unless the Parties agree in good faith and set forth in writing that such costs
equally benefit the Product for use in the Territory and for use outside the
Territory, in which case such costs will be shared equally. In the event that
(a) an expenditure project proposed by Orexigen under this Section 4.3 is not
approved by the JMC (or pursuant to Section 5.7 of the Collaboration Agreement),
(b) Orexigen fails to deliver Product to Takeda in accordance with the terms of
this Agreement, and (c) such failure by Orexigen to deliver Product is a direct
result of Orexigen having not implemented the proposed expenditure project
(i.e., that was not approved by the JMC or otherwise by the Parties pursuant to
Section 5.7 of the Collaboration Agreement), then such failure by Orexigen to
deliver Product to Takeda shall not be deemed a breach of Section 3.6.1(ii) or
(iii). For clarity, (1) Orexigen may invest in and implement expenditure
projects for the manufacture of the Product for use outside of the Territory in
its sole discretion and at its sole cost and benefit, and (2) this Section 4.3
is not intended to address expenditure projects that are intended to be governed
by Sections 4.2, 4.4 and 4.5 of this Agreement.

4.4 Quality Improvements. If either Party identifies manufacturing or quality
improvements that do not result in cost improvements pursuant to Section 4.5,
such Party shall present the proposed projects, expected results and estimated
costs thereof to the JMC for consideration. Orexigen shall have the right in its
sole discretion to implement any manufacturing or quality improvement projects
that are reasonably deemed by Orexigen to be necessary in order to meet its
obligations under this Agreement. With respect to any other manufacturing or
quality improvement project that is contemplated by a Party and that does not
result in cost improvements pursuant to Section 4.5, if the JMC does not approve
such other project, either Party may escalate the Dispute pursuant to
Section 5.7 of the Collaboration Agreement; provided, however, that [***] shall
have final decision-making authority or the right to solely decide a Dispute
related to such other project pursuant to this Section 4.4. For any
manufacturing or quality improvement project that is approved by the JMC (or
pursuant to Section 5.7 of the Collaboration Agreement), or for any
manufacturing or quality improvement project that is reasonably deemed by
Orexigen to be necessary in order to meet its obligations under this Agreement,
the costs of such manufacturing or quality improvement project shall be Period
Costs and allocated in accordance with Section 5.3.1(ii)(b). For clarity,
Orexigen may perform manufacturing or quality improvement projects for the
manufacture of the Product for use outside of the Territory in its sole
discretion and at its sole cost and benefit.

4.5 Cost Improvement Opportunities. The Parties agree to use Commercially
Reasonable Efforts to identify opportunities for cost improvements for
Manufacture of the Product for use in the Territory, including cost savings on
materials and services, as part of an overall cost improvement program. The
Parties shall present to the JMC for consideration the proposed cost improvement
projects, expected results, estimated costs thereof, and proposal for the
allocation between the Parties of (a) [***], and (b) [***]. If the JMC does not
approve a cost improvement project, including such allocation of costs and cost
savings, either Party may escalate the Dispute pursuant to Section 5.7 of the
Collaboration Agreement; provided, however, that [***] shall have final
decision-making authority or the right to solely decide a Dispute related to a
cost improvement project pursuant to this Section 4.5. For any cost improvement
project that is approved by the JMC (or pursuant to Section 5.7 of the
Collaboration Agreement), the Parties shall

 

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set forth in writing the allocation of (a) [***], and (b) [***]. Notwithstanding
anything to the contrary in this Section 4.5, any cost improvement opportunities
implemented by Takeda for Commercial Packaging of the Product will be performed
by Takeda in its sole discretion and at its sole cost, and all savings from such
improvements will be realized solely by Takeda. Orexigen may perform any cost
improvement project that benefits the Manufacture of the Product for use outside
of the Territory in its sole discretion and at its sole cost, and all savings
from such project will be realized solely by Orexigen.

ARTICLE 5

MANUFACTURING PAYMENTS, INVOICING AND PAYMENT

5.1 Manufacturing Payments. In addition to amounts payable pursuant to
Section 5.2, Takeda shall be responsible for Obsolete Material Costs and Period
Costs pursuant to this Agreement. Upon Takeda’s request, Orexigen shall provide
to Takeda copies of the underlying invoices justifying the estimated Transfer
Price, Obsolete Material Costs and Period Costs.

5.2 Transfer Price.

5.2.1 Payment. The purchase price charged by Orexigen for costs associated with
the Manufacture of the Product ordered by Takeda under this Agreement shall be
the estimated Transfer Price. Orexigen shall determine the estimated Transfer
Price in accordance with GAAP or IFRS, as applicable, and based on estimates of
commercially reasonable Third Party costs incurred in support of the
manufacturing supply chain. Upon delivery of the Product in accordance with
Section 6.1, Orexigen may invoice Takeda the estimated Transfer Price for the
type and quantity of the Product delivered. The estimated Transfer Price payable
by Takeda for the Product delivered in each Year will be calculated by tablet on
the basis of the number of Batches of the Product forecasted by Takeda in the
Forecast submitted in the third Calendar Quarter of the prior Calendar Year.
Takeda shall pay the undisputed amount set forth in each original (i.e., not a
copy) invoice delivered by Orexigen under this Section 5.2 within [***] ([***])
days of receipt of such invoice. Any term or condition in an invoice or other
document furnished by Orexigen that is inconsistent with the terms and
conditions of this Agreement or in addition to the terms and conditions of this
Agreement, shall not be binding on Takeda.

5.2.2 Reconciliation.

(a) Within [***] ([***]) days after the end of each Calendar Quarter, Orexigen
shall perform a reconciliation to determine the actual Transfer Price payable
for the Product delivered to Takeda in such Calendar Quarter and shall notify
Takeda of its findings. If the estimated Transfer Price paid to Orexigen for the
Products delivered in such Calendar Quarter is less than the actual Transfer
Price for such Products, Takeda shall pay to Orexigen the difference between
such amounts. Conversely, if the estimated Transfer Price payments made to
Orexigen by Takeda for the Products delivered in such Calendar Quarter exceeds
the actual Transfer Price for such Products, Orexigen shall, at Takeda’s option,
either pay to Takeda the difference between such amounts or credit the
difference against subsequent payments owed by Takeda to Orexigen under this
Agreement until such amount has been fully credited to Takeda.

 

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(b) Within [***] ([***]) days after the end of each Calendar Year, Orexigen
shall perform a reconciliation to determine the actual Transfer Price payable
for the Product delivered to Takeda in such Calendar Year and shall notify
Takeda of its findings. If the estimated Transfer Price paid to Orexigen after
reconciliation pursuant to this Section 5.2.2(a) for the Products delivered in
such Calendar Year is less than the actual Transfer Price for such Products,
Takeda shall pay to Orexigen the difference between such amounts. Conversely, if
the estimated Transfer Price payments made to Orexigen after reconciliation
pursuant to this Section 5.2.2(a) by Takeda for the Products delivered in such
Calendar Year exceeds the actual Transfer Price for such Products, Orexigen
shall, at Takeda’s option, either pay to Takeda the difference between such
amounts or credit the difference against subsequent payments owed by Takeda to
Orexigen under this Agreement until such amount has been fully credited to
Takeda.

(c) Any amounts payable by a Party under this Section 5.2.2 shall be paid within
[***] ([***]) days of receipt of the invoice by either Party.

5.2.3 Shortfall Credit. Annually, and consistent with the Patheon Agreement,
Orexigen will notify Takeda if any Shortfall (as such term is defined in the
Patheon Agreement) credit, prorated by the applicable Capacity Percentage, is
owed to Orexigen pursuant to Section 2.2.3 of the Patheon Agreement with respect
to the Product delivered to Takeda, and Orexigen shall apply any such credit,
prorated by the applicable Capacity Percentage received from Patheon, against
subsequent payments owed by Takeda to Orexigen under this Agreement.

5.3 Period Costs and Obsolete Material Costs Payments.

5.3.1 Payment. For Period Costs and Obsolete Material Costs, Orexigen shall
provide an original (i.e., not a copy) invoice to Takeda within [***] ([***])
days after the Effective Date and thereafter on a Calendar Quarter basis and
Takeda shall be obligated to pay such original invoice in accordance with
Section 5.3.2. Period Costs and Obsolete Material Costs shall be allocated
between the Parties as follows:

(i) for Period Costs and Obsolete Material Costs that [***], Takeda shall pay to
Orexigen an amount equal to [***]; provided, further, Obsolete Material Costs
related to [***] pursuant to the [***] shall be payable by Takeda in accordance
with this Section 5.3.1(i);

(ii) for Obsolete Material Costs, other than such costs related to [***], and
for Period Costs that [***], Takeda shall pay to Orexigen (a) an amount equal to
[***], and (b) an amount equal to [***]; and

(iii) for Period Costs and Obsolete Material Costs that [***], Orexigen shall
bear all such Period Costs and Obsolete Material Costs incurred by Orexigen
during the applicable Calendar Quarter; including any Obsolete Material Costs
related to [***] pursuant [***].

 

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5.3.2 Additional Payment Terms. Prior to First Commercial Sale, and with respect
to each Calendar Quarter thereafter, Orexigen shall provide Takeda with at least
a twelve (12) month forecast of estimated Period Costs. Any term or condition in
an invoice or other document furnished by a Party that is inconsistent or in
conflict with the terms and conditions of this Agreement shall not be binding on
the Parties. Takeda shall pay the undisputed amounts of Obsolete Material Costs
and Period Costs set forth in each written original (i.e., not a copy) invoice
delivered by Orexigen under Section 5.3.1 within [***] ([***]) days of receipt
of such original invoice. In the event Orexigen receives any credit from any
Third Party Manufacturer due to an annual reconciliation pursuant to the
applicable Third Party Manufacturer Agreement with respect to any payment made
by Orexigen to such Third Party Manufacturer and for which Takeda has paid
Orexigen under an invoice described above, Takeda may, at its option, credit
such amount against subsequent payments owed by Takeda to Orexigen under this
Agreement.

5.3.3 Reconciliation. Within [***] ([***]) days after the end of each Calendar
Year, Orexigen shall perform a reconciliation to determine the actual Period
Costs and Obsolete Material Costs payable by Takeda determined pursuant to the
formulas and allocation set forth in Section 5.3.1 for such Calendar Year and
shall notify Takeda in writing of its findings. If such Period Costs and
Obsolete Material Costs paid to Orexigen by Takeda for such Calendar Year are
less than the actual Period Costs and Obsolete Material Costs payable by Takeda
under this Agreement for such Calendar Year, Takeda shall pay to Orexigen the
difference between such amounts. Conversely, if the Period Costs and Obsolete
Material Costs paid to Orexigen by Takeda for such Calendar Year exceed the
actual Period Costs and Obsolete Material Costs payable by Takeda under this
Agreement for such Calendar Year, Orexigen shall, at Takeda’s option, either pay
to Takeda the difference between such amounts or credit the difference against
subsequent payments owed by Takeda to Orexigen under this Agreement until such
amount has been fully credited to Takeda. Any amounts payable by a Party under
this Section 5.3.3 shall be paid within [***] ([***]) days after the date on
which Orexigen notifies Takeda of the amount of the reconciliation payment to be
paid by a Party hereunder.

5.4 Manner of Payment. All payments to be made under this Agreement shall be
made in Dollars by wire transfer of immediately available funds to such U.S.
bank account as shall be designated by a Party. Late payments shall bear
interest at the rate provided in Section 5.10.

5.5 Disputed Amounts. In the event that a Party disputes any amounts payable
under this Agreement, such dispute shall be resolved (a) in accordance with
Article 8 with respect to non-conforming Product and (b) in accordance with
Article 17 with respect to any other dispute. Pending resolution of such
disputes, a Party shall pay any amounts (whether under an invoice or otherwise)
that are not in dispute. Upon resolution of any such dispute in favor of a
Party, the other Party shall pay all remaining amounts owing under this
Agreement within [***] ([***]) Business Days after such resolution.

5.6 Price Increase Resulting from Assignment of Patheon Agreement. In the event
that the cost of the Manufacture of the Product [***] or pursuant to Section 4.2
of the Collaboration Agreement, [***]. If the Manufacturing Responsibility
Transition Plan results in [***].

 

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5.7 Taxes.

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

5.7.2 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. Takeda shall be responsible for the payment of any taxes
(including VAT, sales and use taxes and excluding income or franchise taxes),
customs and excise duties incurred by Takeda with respect to the sale or
importation of the Product by Takeda.

5.7.3 Tax Residence Certificate. A Party (including any entity to which this
Agreement may be assigned, as permitted under Section 14.5 of the Collaboration
Agreement) 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.

5.7.4 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.

5.8 Records. Orexigen shall keep, and, subject to the terms of the applicable
agreement between Orexigen and a Third Party Manufacturer, shall cause each of
its Third Party Manufacturers to keep, full, true, and accurate books of
accounting containing all particulars that may be necessary for the purpose of
calculating the Manufacturing Payments payable to Orexigen

 

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in accordance with GAAP or IFRS, as applicable, under this Article 5, for a
period of [***] ([***]) years after the Calendar Year in which the Product was
delivered, in sufficient detail to permit Takeda to confirm the accuracy of any
Manufacturing Payments paid hereunder.

5.9 Takeda Audit Rights. During the Term and for a period of [***] ([***]) years
thereafter, at the request and expense of Takeda, subject to the terms of the
applicable agreement between Orexigen and a Third Party Manufacturer, Orexigen
shall permit an independent, certified public accountant of nationally
recognized standing appointed by Takeda, and reasonably acceptable to Orexigen,
during normal business hours and upon not less than [***] ([***]) Business Days
prior notice and in compliance with the audit limitations of any Third Party
Manufacture Agreement, but in no case more than [***] per Calendar Year, to
examine such records of Orexigen as may be necessary for the sole purpose of
verifying the calculation and reporting of the Manufacturing Payments for any
period within the preceding [***] ([***]) Calendar Years. Results of any such
examination shall be made available to both Takeda and Orexigen. Such accountant
shall disclose to Takeda only the amounts which the accountant believes to be
due and payable hereunder to Takeda or due and payable to Orexigen, and any
information reasonably necessary for Takeda to evaluate 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 accountant shall be deemed
Orexigen’s Confidential Information, which may not be disclosed by such
accountant to any Third Party. If, as a result of any inspection of the books
and records of Orexigen, it is shown that payments made by Takeda under this
Agreement were more than the amount that should have been made, then Orexigen
shall promptly refund any amount required to eliminate any discrepancy revealed
by said inspection, such refund to occur in any event within [***] ([***]) days
after notice thereof. If, as a result of any inspection of the books and records
of Orexigen, it is shown that payments made by Takeda under this Agreement were
less than the amount that should have been made, then Takeda shall promptly pay
to Orexigen the difference between the amount actually paid and the amount that
should have been paid within [***] ([***]) days after the conclusion of such
inspection. Takeda shall pay for such audits, except that in the event that
Orexigen overcharged the Manufacturing Payments by more than [***] percent
([***]%) during the period in question as per the audit, Orexigen shall pay the
reasonable costs of the audit. Orexigen shall use Commercially Reasonable
Efforts to obtain the consent of any Third Party Manufacturer required (a) for
such accountant to fully and accurately perform the audits described in this
Section 5.9 and (b) for full disclosure to Takeda of the information permitted
to be disclosed by such accountant with respect to the results of such audits.

5.10 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.

 

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ARTICLE 6

DELIVERY, TITLE, AND RISK OF LOSS

6.1 Delivery.

(a) Except for Delivery of Launch Supplies as set forth in Section 3.4, the
Product will be delivered to Takeda’s designated location Ex Works (Incoterms
2010) [***]. Title and risk of loss or damage to the Products will remain with
Orexigen or its Third Party Manufacturer until Orexigen or its Third Party
Manufacturer loads the Products onto the carrier’s vehicle for shipment at the
manufacturing site, at which time title and risk of loss or damage will transfer
to Takeda. Takeda shall be responsible for clearing shipments for export, if
applicable. The Product shall be packed and transported in accordance with the
Specifications.

(b) For determination of meeting the Firm Order delivery date, delivery of the
Product shall be deemed to occur [***]. Orexigen may invoice the estimated
Transfer Price upon delivery of the Product; provided, however, Orexigen shall
have the right to deliver the Product and invoice the estimated Transfer Price
only after (i) the delivery date specified in the Purchase Order for such
Product; (ii) [***], and (iii) [***]. Orexigen agrees that it will [***].
Notwithstanding anything to the contrary in the foregoing, (x) the Parties shall
[***], (y) [***], and (z) [***]. In the event of an unreasonable delay, Orexigen
may (1) invoice Takeda for the price of such Product as Period Costs allocated
in accordance with Section 5.3.1(i), and (2) if the Product is later determined
acceptable, within [***] ([***]) days after receipt of an invoice therefor,
Orexigen will [***] invoice Takeda for the Product as part of the Transfer Price
pursuant to Section 5.2.

6.2 Notice of Potential Failure to Supply. Orexigen shall notify Takeda as soon
as possible of any circumstances that may prevent Orexigen from delivering the
quantity of Batches of the Product ordered by Takeda or meeting the delivery
dates(s) set forth in Takeda’s Firm Orders. Such notice shall in no way be
deemed to excuse any subsequent failure to perform. If the actual tablet yield
for a Batch is less than [***] percent ([***]%) of the Target Yield (as such
term is defined in the Patheon Agreement), Orexigen will notify Takeda as soon
as possible. If additional Batches are required because of such shortfall
between the Target Yield and the actual yield, upon Takeda’s request, Orexigen
will use Commercially Reasonable Efforts to produce additional Batches as
ordered by Takeda to supplement the delivered quantity. Subject to
Section 3.6.1(iii), delivery of one or more Batches with an Actual Annual Yield
below the Target Yield (as such term is defined in the Patheon Agreement) shall
not be considered a failure to supply by Orexigen.

 

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ARTICLE 7

SPECIFICATIONS, FORMULATIONS, LABELING, STABILITY AND

ANTI-COUNTERFEIT MEASURES

7.1 Specifications. Orexigen shall deliver Product that is Manufactured in
accordance with the Specifications, cGMPs and Laws. Release limits for the
Product shall be set by the Parties to be consistent with the approved
shelf-life and Specifications to ensure that the Product meets the
Specifications throughout the approved shelf-life of the Product.

7.2 Release Testing. Orexigen or its Third Party Manufacturer shall test each
Batch of the Product in accordance with the Specifications prior to shipment of
the Product to Takeda. Takeda or its Affiliates shall conduct the applicable
incoming inspections (as set forth in Quality Agreement) of the Product and as
required by Laws and applicable Regulatory Authorities in the Territory.

7.3 Changes to Specifications.

7.3.1 Orexigen-Initiated Changes. Orexigen shall notify Takeda in writing before
making any change to the Specifications, including any change proposed by a
Third Party Manufacturer or a Regulatory Authority. Any such change shall be
subject to Takeda’s prior written approval, not to be unreasonably withheld,
conditioned, or delayed. If, in Takeda’s reasonable determination, the change
will require an amendment or supplement to the Regulatory Approval for the
Product, Orexigen shall not implement the change prior to receipt of written
approval of such change by Takeda. Except as included in the Transfer Price or
as otherwise agreed to by the Parties, the costs to implement such changes shall
be Period Costs and allocated in accordance with Section 5.3.1(ii).

7.3.2 Takeda-Initiated Changes and Changes Required by Law. Takeda shall notify
Orexigen in writing if it desires to make any change to the Specifications. Each
Party shall notify the other Party in writing if it becomes aware of any changes
to the Specifications that are required by Laws. In each case, Orexigen shall
use Commercially Reasonable Efforts to implement any such changes and, if
applicable, have such changes implemented by the applicable Third Party
Manufacturer. To the extent Orexigen incurs Third Party costs itself or under a
Third Party Manufacturer Agreement to implement such changes, such costs shall
be paid solely by Takeda; provided that, prior to undertaking such changes,
Orexigen shall provide Takeda with an estimate of such Third Party costs to
implement such changes and, for changes to the Specifications that are desired
by Takeda but not required by Laws, obtain Takeda’s written approval to proceed.
To clarify, Third Party costs incurred by Orexigen or its Third Party
Manufacturers pursuant to this Section 7.3.2 shall be Period Costs and allocated
in accordance with Section 5.3.1(i).

7.3.3 No Amendment Required. Upon mutual written agreement of the Parties with
respect to any revised Specifications, or in the event the Specifications are
updated in the NDA for the Product, such revised Specifications shall be
attached hereto and no formal amendment of this Agreement shall be necessary for
such revised Specifications to become effective.

 

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7.4 Product Stability. Takeda shall notify Orexigen of its annual commitments
made to Regulatory Authorities with respect to ongoing stability testing of the
Product, such notice to be provided to Orexigen not later than [***] ([***])
days prior to Takeda’s submission of such commitments to any such Regulatory
Authority. Orexigen shall put the Product lots on stability testing as required
by such commitments. In addition, from time to time, Takeda may request that
Orexigen conduct additional studies designed to test the stability of the
Product. With respect to such other stability studies requested by Takeda,
Orexigen shall conduct such studies, and, where the assistance of Third Party
Manufacturer(s) is required, shall use Commercially Reasonable Efforts to
implement such studies at Third Party Manufacturer(s)’ site(s). Any costs
incurred by Orexigen and its Third Party Manufacturer in connection with
stability testing of Product solely for the Territory shall be Period Costs and
allocated in accordance with Section 5.3.1(i). Any costs incurred by Orexigen
and its Third Party Manufacturer in connection with stability testing of Product
solely for the benefit of use of the Product outside the Territory shall be
shall be Period Costs and allocated in accordance with Section 5.3.1(iii). Any
costs in connection with stability testing that benefits the Product for use in
the Territory and for use outside of the Territory shall be Period Costs and
allocated in accordance with Section 5.3.1(ii).

7.5 Anti-Counterfeit Measures. From time to time Takeda may request that
Orexigen undertake reasonable anti-counterfeit measures to protect the integrity
of the Product. Orexigen shall assist in implementing such measures and, where
the assistance of Third Party Manufacturer(s) is required, shall use
Commercially Reasonable Efforts to implement such measures at Third Party
Manufacturer(s). The costs incurred by the Parties in the implementation of such
measures shall be Period Costs and allocated in accordance with
Section 5.3.1(i).

ARTICLE 8

NON-CONFORMING PRODUCT

8.1 Acceptance and Rejection. Takeda, its Affiliates and/or its or their
subcontractors will visually inspect each shipment of the Product upon receipt
thereof. Takeda may reject and return any part of a shipment of the Product or
the entire shipment of the Product if any part does not conform to the
Specifications, cGMPs or Laws, based on the acceptance criteria set forth in the
Quality Agreement, by giving written notice to Orexigen within [***] ([***])
days after receipt of such shipment. Such notice shall identify the reasons for
Takeda’s rejection of the shipment. Subject to Section 8.2, if Orexigen does not
receive a notice of rejection within such [***] ([***]) day period, Takeda shall
be deemed to have accepted such shipment of the Product.

8.2 Latent Defects. If, after accepting a shipment of the Product, Takeda
subsequently discovers an alleged Product defect not reasonably discoverable by
visual inspection during the acceptance period set forth in Section 8.1, Takeda
may revoke its acceptance and reject such shipment by giving written notice and
disclosing the nature of such defect to Orexigen within [***] ([***]) days after
discovering such defect but not after the expiry date of the Product.

 

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8.3 Evaluation of Defect. After notice of rejection pursuant to Section 8.1 or
8.2 is received by Orexigen, Orexigen shall promptly notify Patheon of such
rejection in accordance with Article 6 of the Patheon Agreement. Orexigen shall
give Takeda a reasonable opportunity to review and comment on such notice before
it is delivered to Patheon. Orexigen shall notify Takeda within [***] ([***])
Business Days after delivery of such notice to Patheon whether Patheon disagrees
with the reasons for Takeda’s rejection of the Product. If Patheon notifies
Orexigen that it disagrees with the reasons for Takeda’s rejection, Orexigen
shall, unless waived in writing by Takeda, have the issue determined by an
independent laboratory in accordance with Article 6 of the Patheon Agreement.
Orexigen shall cooperate with Patheon to cause the independent laboratory to
conduct its evaluation as promptly as reasonably practicable. Orexigen shall
work closely with Takeda in preparing all statements, reports, analyses and
other materials submitted to the independent laboratory for evaluation. The
evaluation of the independent laboratory will be binding on Orexigen and Takeda.
If the evaluation certifies that the Product deviates from the Specifications,
cGMPs or Laws, Takeda may reject the Product as provided hereunder, and as
between Orexigen and Takeda, Orexigen shall be responsible for the cost of the
evaluation to the extent Orexigen recovers such costs from Patheon. If the
evaluation does not certify any deviation of the Product, then Takeda will be
deemed to have accepted such Product, which will be deemed to be conforming on
the date the evaluation is delivered by the independent laboratory, and Takeda
will reimburse Orexigen for the costs of such evaluation; provided, however,
that Takeda may determine, in its sole discretion, not to use such Product. With
respect to Products which Patheon agrees are deficient in accordance with
Takeda’s notice of rejection, or which are otherwise found to be deficient by
the independent laboratory, Orexigen shall, at Takeda’s option, either refund to
Takeda the Transfer Price paid by Takeda for such Products or replace such
Products at no charge solely to the extent Orexigen has been reimbursed by
Patheon or Patheon has provided such replacement Product at no charge to
Orexigen. The Parties shall evaluate process issues and other reasons for
non-compliance of the Product with the Specifications, cGMPs or Laws.

8.4 Disposition of Rejected Product. Takeda may not destroy any damaged,
defective, returned or recalled Product for which it intends to send Orexigen a
notice of rejection without Orexigen’s prior written authorization to do so,
such authorization not to be unreasonably withheld, conditioned or delayed.
Alternatively, Orexigen may instruct Takeda to return the defective Product to
Orexigen or to Patheon. Orexigen shall bear the costs of shipping, storage and
disposition for any damaged, defective, returned or recalled Product for which
it bears responsibility under this Article 8 and will promptly reimburse Takeda
for any such costs which may be incurred directly by Takeda solely to the extent
Orexigen has been reimbursed by Patheon for such costs. Notwithstanding the
foregoing, Takeda will have the right at all times to retain a reasonable sample
of such Product for its own archival purposes.

ARTICLE 9

QUALITY ASSURANCE

9.1 Quality Agreement. The Parties will promptly enter into a quality agreement
governing the quality assurance obligations of the Parties with respect to the
Manufacture and supply of the Product (as it may be amended or modified from
time to time according to its terms, the “Quality Agreement”). In the event of a
discrepancy between the provisions of the Quality Agreement and the provisions
of this Agreement, the provisions of the Quality Agreement shall control with
respect to terms governing quality of the Product and the provisions of this
Agreement shall control with respect to all other terms.

 

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9.2 Quality Control and Quality Assurance.

9.2.1 Quality Control. Orexigen shall ensure that all Product supplied to Takeda
hereunder is Manufactured, stored, tested, transported, disposed of and
otherwise handled in accordance with the Specifications, cGMPs, Laws, and the
Quality Agreement. Orexigen shall, and shall ensure that its Third Party
Manufacturers, maintain and follow a quality control and quality assurance
testing program consistent with the Quality Agreement.

9.2.2 Quality Documentation to Accompany Each Product Shipment. Each time
Orexigen or a Third Party Manufacturer ships the Product to Takeda, it will
provide Takeda with the documentation specified herein and in the Quality
Agreement.

9.2.3 Validation Activities. At Takeda’s request and expense, Orexigen shall use
Commercially Reasonable Efforts to complete requested validation activities to
support Manufacturing for the Territory and the cost of such activities shall be
Period Costs and allocated in accordance with Section 5.3.1.

9.3 Inspections by and Communications from Regulatory Authorities.

9.3.1 Right to Inspect. Orexigen shall make, and shall ensure that its Third
Party Manufacturers make, its internal practices, books and records relating to
the Manufacture of the Product available and allow access to all facilities used
for the Manufacture of the Product to any Regulatory Authority having
jurisdiction over the Manufacture of the Products for the purposes of
determining Orexigen’s and/or its Third Party Manufacturers’ compliance with
cGMPs and Laws, subject to the terms of the applicable Third Party Manufacturer
Agreement. Orexigen shall notify Takeda of Regulatory Authority inspections
related to the Manufacture of the Product by the process outlined in the Quality
Agreement.

9.3.2 Notice of Actions. Orexigen shall promptly inform Takeda if Orexigen
becomes aware of any action taken by a Regulatory Authority against Orexigen or
any Third Party Manufacturer or any of their officers and/or employees that
could reasonably be expected to materially impact the Product or Orexigen’s
ability to supply the Product hereunder, and shall provide a copy of such notice
to Takeda within [***] after Orexigen has actual knowledge that such action has
been taken.

9.3.3 Cooperation. Orexigen shall cooperate with Takeda and with Regulatory
Authorities in response to any communication, whether oral or written, from a
Regulatory Authority to Takeda or Orexigen or any Third Party engaged by either
Party, with regard to any activity relating to the Manufacture of the Product,
including validation, prior to the Effective Date and throughout the Term.

 

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9.4 Quality Audits. Prior to shipment of Launch Supplies, and thereafter
biennially or as otherwise mutually agreed by the Parties, subject to the terms
of the applicable Third Party Manufacturer Agreement, Orexigen shall, conduct
and lead cGMP audits of the Third Party Manufacturers and, if applicable,
exercise such other audit rights that Orexigen may have under such Third Party
Manufacturer Agreements, and shall disclose to Takeda the complete results of
such audits, subject to the terms of the applicable Third Party Manufacturer
Agreement. Takeda may request “for cause” audits in addition to the regularly
scheduled audits. Unless prohibited by such Third Party Manufacturer Agreements,
Takeda shall be permitted to have a maximum of [***] ([***]) representatives
present at all times during the audit, under the direction of Orexigen. If
requested by Takeda, Orexigen shall use Commercially Reasonable Efforts to
obtain permission from a Third Party Manufacturer for Takeda’s representatives
to be present during such audits and for Takeda to receive a copy of the results
of such audits. Orexigen shall use Commercially Reasonable Efforts to cause such
Third Party Manufacturers to promptly correct any deficiencies or other adverse
findings and shall keep Takeda apprised of the same. Orexigen shall provide
Takeda with copies of all corrective action plans addressing any audit findings
and shall consider in good faith any comments that Takeda provides to Orexigen
with respect to such plan.

9.5 Licenses, Permits. Each Party shall maintain, to the extent required by Laws
in connection with such Party’s performance of its obligations hereunder, and
shall require its Third Party Manufacturers to maintain during the Term, all
government permits, including health, safety and environmental permits,
necessary for the Manufacture of the Product pursuant to this Agreement.

9.6 Documentation and Samples. Orexigen shall maintain, to the extent required
by Laws in connection with Orexigen’s performance of its obligations hereunder,
and shall require its Third Party Manufacturers to maintain, in accordance with
cGMPs and other Laws, complete, accurate and authentic accounts, notes, data and
records pertaining to the Manufacture and testing of the Product. Orexigen shall
make such records available to Takeda for inspection promptly following Takeda’s
written request, subject to the terms of the applicable Third Party Manufacturer
Agreement. Orexigen shall retain (itself or through its Third Party
Manufacturers) samples from each Batch supplied under this Agreement after
Takeda’s acceptance of such Batch under Article 8. Orexigen shall, at Takeda’s
expense, retain such records or samples (as applicable) for a period of at least
[***] ([***]) years following the date of expiration of such samples, or longer
if required by Laws, and upon Takeda’s written request shall make available to
Takeda copies of such records and portions of such samples, subject to the terms
of the applicable Third Party Manufacturer Agreements. Takeda shall reimburse
Orexigen for reasonable out-of-pocket costs incurred to retain and make
available such records and samples.

9.7 Product Complaints. The Quality Agreement shall set forth the Product
complaint process. However, it is understood and agreed that (i) Takeda shall
have the sole right and responsibility for receiving, evaluating, reporting and
responding to any non-medical complaints related to the Product sold by Takeda
or its Affiliates or permitted Sublicensees in the Territory to the applicable
Regulatory Authorities; (ii) Orexigen shall forward all Product complaints
received by Orexigen within the time period specified in the Quality Agreement,
but in any event, promptly after receipt; and (iii) Orexigen will provide to
Takeda all reasonable assistance in complying with such reporting requirements,
including investigating complaints relating to the Product through the review of
all Manufacturing related activities. Each Party shall

 

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designate a representative who will handle Product complaint activities for such
Party and coordinate such activities with the other Party. Matters affecting
Product safety, including lack of efficacy, shall be handled in accordance with
the terms of the Collaboration Agreement and the Pharmacovigilance Agreement.

ARTICLE 10

PRODUCT RECALL

10.1 Conduct of Recall. Recalls shall be conducted in accordance with
Section 3.7 of the Collaboration Agreement.

10.2 Responsibility for Recall Costs. “Recall Costs” shall mean all reasonable
direct, documented out-of-pocket costs associated with a Recall including the
expenses of notifications and investigations, and destruction or return of the
Product subject to the Recall and any costs associated with the distribution of
the replacement Product. Recall Costs will be (a) the responsibility of [***],
or (b) [***]; provided, however, that [***].

10.3 Remedies from Patheon for Recalled Products. Orexigen shall use
Commercially Reasonable Efforts to obtain from Patheon either a refund of the
invoice price for recalled Products or conforming Products to replace the
recalled Products if Orexigen is entitled to such remedies under the terms of
Section 6.3(b) (or any successor provision) of the Patheon Agreement, and
Orexigen shall, to the extent that it obtains any such remedy, pay over to
Takeda the amounts recovered from Patheon or, if requested by Takeda, instead
provide to Takeda replacement Products to the extent Orexigen is able to obtain
such replacement Products from Patheon pursuant to Section 6.3(b)(iii) (or any
successor provision) of the Patheon Agreement; provided that Takeda shall
reimburse Orexigen any costs incurred by Orexigen with respect to recalled or
replacement Products pursuant to Section 10.2.

10.4 Notice. Each Party shall notify the other Party promptly, but in any event,
within [***] ([***]) Business Days if it becomes aware that any product (other
than the Product) Manufactured at any Third Party Manufacturer is recalled or
withdrawn from the market due to causes which may have an adverse effect on the
Product (including any decision to refrain from selling or shipping quantities
of any such product). Each Party shall provide the other Party with any
information it may reasonably request to evaluate the effect of such recall or
withdrawal on the Product.

ARTICLE 11

REPRESENTATIONS AND WARRANTIES;

DISCLAIMERS OF LIABILITY; AND LIMITATION OF LIABILITY

11.1 Mutual Representations and Warranties. Each Party hereby represents and
warrants to the other Party, as of the Effective Date, that:

11.1.1 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;

 

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

11.1.3 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;

11.1.4 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;

11.1.5 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

11.1.6 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 except as may be required to obtain clearance under the HSR
Act; and

11.1.7 neither it, 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.

11.2 Additional Representations and Warranties of Orexigen. As of the Effective
Date and throughout the Term, Orexigen represents, warrants and covenants the
following, as applicable, to Takeda that:

11.2.1 the Product shall, at the time of delivery to Takeda hereunder meet the
Specifications;

11.2.2 the Product shall be Manufactured and tested in accordance with Laws and
cGMPs;

11.2.3 the Product shall not be adulterated or misbranded within the meaning of
the United States Food, Drug and Cosmetic Act, 21 U.S.C. Section 301c et.seq. or
other Laws;

 

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11.2.4 it has and will maintain, and its Third Party Manufacturers have and will
maintain, the expertise with respect to personnel and equipment necessary to
fulfill the obligations established hereunder;

11.2.5 it has obtained, or will obtain, and its Third Party Manufacturers have
obtained, or will obtain, all requisite material licenses, authorizations and
approvals required by any Regulatory Authorities to Manufacture the Product;

11.2.6 each Third Party Manufacturer Agreement contains provisions requiring all
facilities used by such Third Party Manufacturer in the Manufacture of the
Product, including the Manufacture of the Licensed Compounds, to be currently,
and at the time each Batch is produced, qualified in accordance with Laws,
including cGMPs;

11.2.7 During the [***] ([***]) year period commencing on the first date of
Manufacture of the Product, all Product (other than Launch Supplies)
Manufactured and delivered under this Agreement by Orexigen shall, at the time
of delivery to Takeda, have [***] for which no more than (a) [***] ([***])
months shall have elapsed since the date of [***] or (b) [***] ([***]) months
have elapsed since the date of [***], unless, in each of (a) and (b), otherwise
agreed to in writing by the Parties; provided, that, such [***] ([***]) month
period and [***] ([***]) month period, respectively, shall be extended by one
(1) day for each day of any dispute resolution process with respect to such
Product. Notwithstanding anything to the contrary in this Agreement, the first
[***] ([***]) Batches of the Product delivered to Takeda following Delivery of
Launch Supplies shall, at the time of delivery to Takeda, have [***] for which
no more than [***] ([***]) months shall have elapsed since the date of
Manufacture. For clarity, if Takeda extends [***] [***] following Regulatory
Approval, the Parties shall negotiate in good faith to determine the [***] for
the Product upon delivery to Takeda. After the initial [***] ([***]) year period
of Manufacture of the Product, unless otherwise mutually agreed to by the
Parties, all Product Manufactured and delivered under this Agreement by Orexigen
shall, at the time of [***], have [***] for which no more than [***] ([***])
months shall have elapsed since the date of [***], unless otherwise agreed to in
writing by the Parties; provided, that, such [***] ([***]) month period shall be
extended by one (1) day for each day of any dispute resolution process with
respect to such Product;

11.2.8 it will not in the performance of its obligations under this Agreement
use the services of any person (including any Third Party Manufacturer) that, to
its Knowledge, is debarred or suspended under 21 USC §335(a) or (b); and

11.2.9 as of the Effective Date, it does not currently have, and covenants that
it will not hire, as an officer or an employee any Person who, to its Knowledge,
has been convicted of a felony under the laws of the U.S. for conduct relating
to the regulation of any drug product under the Federal Food Drug and Cosmetic
Act, as amended.

 

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11.3 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT OR IN THE
COLLABORATION AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES
OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED
WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO THE PRODUCT.

11.4 Limitation of Liability. EXCEPT FOR A BREACH OF ARTICLE 15, OR FOR CLAIMS
OF A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER ARTICLE 12, NEITHER
PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS
AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER
LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY,
PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS, LOSS OF
USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS).

ARTICLE 12

INDEMNIFICATION AND INSURANCE

12.1 Indemnity. The indemnification rights and obligations of the Parties set
forth in Article 11 of the Collaboration Agreement shall apply to this
Agreement.

12.2 Insurance. The insurance obligations of the Parties set forth in Article 11
of the Collaboration Agreement shall apply to this Agreement.

ARTICLE 13

TERM AND TERMINATION

13.1 Term. This Agreement shall become effective as of the Effective Date and
shall continue in full force and effect until the expiration or termination of
the Collaboration Agreement unless terminated earlier pursuant to this Article
13 (the “Term”).

13.2 Termination Pursuant to the Completion of a Manufacturing Responsibility
Transition Plan or Assignment of Third Party Manufacturing Agreements. This
Agreement shall automatically, and without any further action by either Party,
terminate upon the completion of (a) the transfer of the right and
responsibility to Manufacture or have Manufactured the Product for the Territory
to Takeda pursuant to Section 4.2 of the Collaboration Agreement, and (b) if
elected by Takeda, the assignment to Takeda of all of the Third Party
Manufacturer Agreements required for Manufacture of the Product in the Territory
as set forth in Section 3.6.1(b).

ARTICLE 14

CONSEQUENCES OF TERMINATION

14.1 Continuation of Supply. If the Term ends upon the expiration of the
Collaboration Agreement, then, at Takeda’s election, Orexigen shall (a) continue
to supply Takeda’s requirements for the Product in the Territory in accordance
with the terms of this Agreement for a period of up to [***] ([***]) months
following such expiration or (b) assign to

 

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Takeda those Third Party Manufacturer Agreements requested by Takeda, to the
extent permitted under the applicable Third Party Manufacturer Agreement and to
the extent required for the Manufacture of the Product for the Territory. At
Takeda’s request, Orexigen shall use Commercially Reasonable Efforts to obtain
from the applicable Third Party Manufacturer any consent required for such
assignment, at Takeda’s cost. If the Term ends upon the termination of the
Collaboration Agreement, Orexigen shall not have continuing supply
responsibilities hereunder (except as set forth in Section 14.2).

14.2 In-Process Product. Promptly after expiration of this Agreement or
termination of this Agreement as a result of termination of the Collaboration
Agreement by Takeda pursuant to Section 12.2.1, 12.4, or 12.5 of the
Collaboration Agreement, if requested by Takeda, Orexigen will complete work on
all Products that were in process for the Territory at the time of expiration or
termination and, following completion of such work, deliver such Products to
Takeda. Takeda will pay Orexigen the Transfer Price determined pursuant to
Section 5.2 for all such Products supplied by Orexigen to Takeda, and any unpaid
Obsolete Material Costs and Period Costs and any other costs set forth in this
Agreement associated with such Products. For any remaining materials or if
Takeda elects not to complete production of in-process Products, Takeda will pay
for any raw materials and/or work in process ordered for but not consumed by the
completion of in-process Product and any destruction charges.

14.3 Accrued Obligations. Termination or expiration of this Agreement shall not
relieve either Party of any accrued obligations hereunder.

14.4 Without Prejudice. Termination of this Agreement, due to the fault of
either Party, shall be without prejudice to any other rights or remedies then or
thereafter available to either Party under this Agreement or otherwise.

14.5 Survival. The following provisions shall survive termination or expiration
of this Agreement in its entirety, and, any other provisions, which by their
terms or by the context thereof, are intended to survive such expiration or
termination, shall also survive: Article 1 (Definitions); Article 5 (Purchase
Price, Invoicing and Payment); Article 8 (Non-Conforming Product); Article 10
(Product Recall); Article 12 (Indemnification and Insurance); Article 14
(Consequences of Termination), as applicable; Article 15 (Confidentiality);
Article 16 (Miscellaneous); and Article 17 (Dispute Resolution), and
Section 9.6; Section 11.3; and Section 11.4.

ARTICLE 15

CONFIDENTIALITY

The provisions of Article 10 of the Collaboration Agreement shall apply to the
Confidential Information of a Party disclosed to the other Party in connection
with the activities under this Agreement.

 

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ARTICLE 16

MISCELLANEOUS

16.1 Miscellaneous. The rights and obligations of the Parties set forth in
Sections 14.1 through 14.9 and 14.11 through 14.14 of the Collaboration
Agreement shall apply to this Agreement.

16.2 Government Subcontracts.

16.2.1 Orexigen represents and warrants that it will comply with all applicable
laws throughout the term of this Agreement, including providing all required
written certifications, representations, and disclosures. Specifically, Orexigen
represents and warrants that it will comply, [***], with applicable requirements
of the following Federal Acquisition Regulation (“FAR”) clauses, which are
hereby incorporated by reference and made a part of this Agreement as if fully
set forth herein: (i) FAR 52.203-13, Contractor Code of Business Ethics and
Conduct (Apr. 2010); (ii) FAR 52.219-8, Utilization of Small Business Concerns
(Dec. 2010) (15 U.S.C. § 637(d)(2) and (3)); (iii) FAR 52.222-26, Equal
Opportunity (Mar. 2007) (Executive Order 11246); (iv) FAR 52.222-35, Equal
Opportunity for Veterans (Sep. 2010) (38 U.S.C. § 4212); (v) FAR 52.222-36,
Affirmative Action for Workers with Disabilities (Oct. 2010) (29 U.S.C. § 793);
(vi) FAR 52.222-40, Notification of Employee Rights Under the National Labor
Relations Act (Dec. 2010) (E.O. 13496); (vii) FAR 52.222-50 Combating
Trafficking in Persons (Feb. 2009) (22 U.S.C. 7104(g)) and (viii) FAR 52.247-64,
Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006).

16.2.2 Takeda and Orexigen shall abide by the requirements of 41 CFR §§
60-1.4(a), 60-300.5(a) and 60-741.5(a). These regulations prohibit
discrimination against qualified individuals based on their status as protected
veterans or individuals with disabilities, and prohibit discrimination against
all individuals based on their race, color, religion, sex, or national origin.
Moreover, these regulations require that covered prime contractors and
subcontractors, such as Takeda and Orexigen take affirmative action to employ
and advance in employment individuals without regard to race, color, religion,
sex, national origin, protected veteran status or disability.

16.3 No Government Contracting Debarment. BY ACCEPTANCE OF THIS AGREEMENT,
OREXIGEN HEREBY CERTIFIES THAT NEITHER OREXIGEN NOR ANY OF OREXIGEN’S PRINCIPALS
IS PRESENTLY DEBARRED, SUSPENDED, PROPOSED FOR DEBARMENT, DECLARED INELIGIBLE OR
VOLUNTARILY EXCLUDED FOR THE AWARD OF CONTRACTS BY ANY U.S. FEDERAL AGENCY.

16.4 Entire Agreement. This Agreement, including the attached exhibits, and the
Collaboration Agreement (excluding Exhibit 4.1 of the Collaboration Agreement)
constitute the entire agreement between the Parties as to the subject matter of
this Agreement, and supersedes and merges all prior and contemporaneous
negotiations, representations, agreements and understandings regarding the same.
Exhibit 4.1 and Section 4.3 of the Collaboration Agreement are expressly
superseded by this Agreement, except with respect to references in the
Collaboration

 

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Agreement (other than in Exhibit 4.1 of the Collaboration Agreement) to:
(i) Exhibit 4.1 of the Collaboration Agreement, including in the paragraph at
the end of Section 7.2.1 of the Collaboration Agreement, and (ii) Section 4.3 of
the Collaboration Agreement. Sections 4.2, 4.3, 4.4 and 4.5 expressly amend
Orexigen’s final decision-making authority as provided in Section 5.7.3(b)(ii)
of the Collaboration Agreement. To the extent there is a conflict between this
Agreement and the Collaboration Agreement other than as set forth in this
Section 16.4, the Collaboration Agreement shall control.

16.5 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; (h) the word “or” has, except where
otherwise indicated, the inclusive meaning represented by the phrase “and/or”;
and (i) all references to “days” in this Agreement are to calendar days unless
such reference is to a Business Day.

ARTICLE 17

DISPUTE RESOLUTION

17.1 Exclusive Dispute Resolution Mechanism. Except as set forth in Section 8.3,
the Parties agree that the Dispute resolution procedures set forth in Article 13
of the Collaboration Agreement shall be the exclusive mechanism for resolving
any Dispute that is not resolved through good faith negotiation between the
Parties.

17.2 Confidentiality. Any and all activities conducted under this Article 17,
including any and all proceedings and decisions of arbitrator(s), shall be
deemed Confidential Information of each of the Parties, and shall be subject to
Article 15.

[Signature Page Follows]

 

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

 

OREXIGEN THERAPEUTICS, INC.

    TAKEDA PHARMACEUTICAL COMPANY LIMITED By:   /s/ Michael A. Narachi     By:  
/s/ Testuo Miwa

Name: Michael A. Narachi

    Name: Tetsuo Miwa

Title:   President & CEO

    Title:   Senior Vice President, Pharmaceutical Production Division

Date: September 2, 2014

    Date: August 29, 2014

OREXIGEN THERAPEUTICS, INC.

    TAKEDA PHARMACEUTICAL COMPANY LIMITED By:   /s/ Joseph P. Hagan     By:  
/s/ Hideki Matsubara

Name: Joseph P. Hagan

    Name: Hideki Matsubara

Title:   Chief Business Officer

   

Title:    Senior Director, General Purchasing

Department Pharmaceutical Production Division

Date: September 2, 2014

    Date: August 29, 2014

OREXIGEN THERAPEUTICS, INC.

      By:   /s/ Philip Roberts      

 

Name: Philip Roberts

     

Title:   VP, Technical Operations

     

Date: September 2, 2014

     

 

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Exhibit 1.25

Product

Bulk drug Product: naltrexone hydrochloride and bupropion hydrochloride 8mg/90mg
trilayer film-coated tablets [***].

 

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Exhibit 1.31

Specifications

Bulk Packaging Specifications

 

[***]    [***]    [***]    [***]    [***]    [***]   

Product Specifications (see below)

 

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LOGO [g782731logo.jpg]   Material Specification  

8 mg Naltrexone Hydrochloride 90 mg

Bupropion Hydrochloride Tablet

(for Commercial)

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Specification(s) (Contrave, Tablets)

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Attribute

  

Acceptance Criteria

   Method

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Exhibit 2.3.1

Third Party Manufacturers and Agreements

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