Exhibit 10.23

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

BUPROPION HYDROCHLORIDE SUPPLY AGREEMENT

This Bupropion Hydrochloride Supply Agreement (this “Agreement”) is made as of
this day of November 24, 2009 (the “Effective Date”) by and among OREXIGEN
THERAPEUTICS, INC. (“OREXIGEN”), a Delaware corporation located at 3344 N.
Torrey Pines Court, Suite 200, La Jolla, CA 92037, and CHEMI S.p.A. (“CHEMI”), a
corporation of Italy located at via dei Lavoratori, 54 -20092, Cinisello Balsamo
(Milan).

WHEREAS, CHEMI is the manufacturer of Bupropion Hydrochloride and is
contractually responsible for Bupropion Hydrochloride and whereby CHEMI wishes
to sell and manufacture Bupropion Hydrochloride to OREXIGEN on the terms
described herein; and

WHEREAS, OREXIGEN desires a supply of commercial quantities of Bupropion
Hydrochloride on the terms described herein.

NOW, THEREFORE, in consideration of the mutual covenants set forth herein, CHEMI
and OREXIGEN (each, a “Party” and, collectively, the “Parties”) agree as
follows.

 

1. SCOPE OF AGREEMENT

 

1.1. This Agreement shall apply to all purchases of Bupropion Hydrochloride by
OREXIGEN from CHEMI during the term of this Agreement. The premises and the
Schedules and Appendix attached hereto constitute an integrant and substantial
part of this Agreement.

 

1.2. This Agreement does not constitute a purchase order. Purchases under this
Agreement shall be made only with purchase orders issued by OREXIGEN to CHEMI
(each, a “Purchase Order”). Each Purchase Order shall set forth the information
required by Section 3.3 and shall be in the form attached hereto as Appendix A.
All terms and conditions of the Purchase Orders shall apply, provided that in
the event of a conflict or inconsistency between the terms of any Purchase
Order, order acknowledgement, invoice, shipping terms, packaging slip or other
documentation, and the terms of this Agreement, the terms of this Agreement
shall control and prevail and such additional or inconsistent terms are hereby
expressly rejected, unless such documentation specifically states that it
overrides conflicting terms of this Agreement and is signed by each of the
Parties.

 

1.3. All Bupropion Hydrochloride sold by CHEMI to OREXIGEN will be manufactured
by CHEMI in accordance with the terms of this Agreement.

 

2. MANUFACTURING; SPECIFICATIONS

 

2.1.

CHEMI shall supply the Bupropion Hydrochloride to OREXIGEN in accordance with
(a) the specifications set forth on Schedule A attached hereto, and (b) the
specifications, methods, processes and procedures, including site of
manufacture, set forth in CHEMI’s drug master file (“DMF”) for Bupropion
Hydrochloride filed with the U.S. Food and Drug Administration (“FDA”) pursuant
to Section 2.3 (both (a) and (b), including any

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modifications approved in accordance with Section 2.2 collectively, the
“Specifications”). If CHEMI wishes to make any change to the Specifications
(including, but not limited to, any change that could affect the purity,
potency, identity and/or physical properties of the Bupropion Hydrochloride or
the site of its manufacture), it shall notify OREXIGEN in writing in advance
thereof and comply with the requirements of Section 2.2 prior to implementing
such change. Such notification shall describe the proposed change in sufficient
detail, so as to permit OREXIGEN to understand the reasons for the proposed
change and evaluate the impact of such change on its development plans, its
plans to seek regulatory approval and its commercialization plans with respect
to oral formulations containing Bupropion Hydrochloride (the “Finished
Products”). OREXIGEN may request from time to time that CHEMI implement
voluntary changes to the Specifications upon written request to CHEMI. CHEMI
shall use commercially reasonably efforts to implement such request from
OREXIGEN, which if carried out shall be at OREXIGEN’s expense. In the event that
a voluntary change to the Specifications is to be implemented, CHEMI shall
perform, at OREXIGEN’s expense, all analytical or experimental work in
connection with making any such changes, but OREXIGEN shall be responsible, at
its expense, for filing all changes proposed by OREXIGEN in connection with any
regulatory approval, and for seeking approval of any such change required by
each applicable Regulatory Agency (as defined in Section 2.2).

 

2.2. Without limiting the generality of the foregoing provisions, CHEMI shall
not change the Specifications unless [* * *], each having jurisdiction over
Bupropion Hydrochloride, the Finished Products or OREXIGEN’s marketing of
Finished Products (each a “Regulatory Agency”). If any change to the
Specifications requires the approval of a Regulatory Agency, such change
[* * *]. To the extent [* * *]. For the avoidance of doubt, CHEMI shall not
supply to OREXIGEN hereunder, and OREXIGEN shall have no obligation to accept,
any Bupropion Hydrochloride from CHEMI manufactured in contravention of this
Section 2.2.

 

2.3. CHEMI will take commercially reasonable steps necessary to enable OREXIGEN
to secure from the relevant Regulatory Agencies approval of CHEMI as a source of
supply of Bupropion Hydrochloride for OREXIGEN’s Finished Products to be
marketed anywhere in the world. Without limiting the generality of the
foregoing, CHEMI will supply to OREXIGEN sufficient quantities of Bupropion
Hydrochloride to enable OREXIGEN to support the filing of one or more New Drug
Applications (the “NDA”) (or Abbreviated New Drug Application (“ANDA”), if
applicable), together with all amendments and supplements thereto, referencing
CHEMI as its supplier of Bupropion Hydrochloride for its initial Finished
Product candidate. CHEMI will be responsible for procuring and maintaining all
regulatory filings and any other compliance efforts, including without
limitation, the DMF, related to Bupropion Hydrochloride that are required in
order to obtain approval from the FDA of OREXIGEN’s NDAs (or ANDAs, if
applicable) referencing Bupropion Hydrochloride and equivalent approvals from
Regulatory Agencies in other jurisdictions, at no additional cost to OREXIGEN.
CHEMI has filed the DMF with the FDA and has provided the DMF’s reference number
in writing to OREXIGEN at least [* * *] ([* * *]) days prior to Orexigen’s
filing of an NDA (or ANDA, if applicable). OREXIGEN shall have the right to
reference the DMF in its

 

 

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NDAs (or ANDAs, if applicable) and equivalent approvals from Regulatory Agencies
in jurisdictions outside the United States, and the right to access the open
part of the DMF.

 

2.4. CHEMI shall test, or have tested, each lot of Bupropion Hydrochloride
shipped to OREXIGEN using the analytical testing methodologies which are set
forth in the Specifications in order to assure the conformity of each lot of
Bupropion Hydrochloride supplied hereunder to the Specifications and all
Applicable Laws (as defined in Section 8.1.1). With each shipment of Bupropion
Hydrochloride, CHEMI shall deliver to OREXIGEN certificates of analysis and
compliance from CHEMI (a) stating that the Bupropion Hydrochloride being shipped
has been tested and does conform to the Specifications, (b) setting forth in
detail the testing methodology employed by CHEMI in making the foregoing
determination and the results generated by such tests, and (c) confirming
compliance with the current good manufacturing practices (“cGMP”) required by
the FDA, and other relevant Regulatory Agencies in those jurisdictions of which
OREXIGEN has given CHEMI notice, with respect to the manufacture and testing of
Bupropion Hydrochloride for use as an active pharmaceutical ingredient in the
Finished Products and subsequent sale in such jurisdictions.

 

3. FORECASTS; FIRM COMMITMENT; PURCHASE ORDERS

 

3.1. In order to assist CHEMI in planning the production runs for Bupropion
Hydrochloride, beginning at least [* * *] ([* * *]) [* * *] prior to OREXIGEN’s
anticipated Commercial Launch (as defined in Section 3.2), OREXIGEN shall use
its commercially reasonable efforts to provide to CHEMI, prior to the beginning
of each calendar quarter, a twelve (12) month rolling forecast of the quantities
of Bupropion Hydrochloride required by OREXIGEN, by month, for the following
twelve (12) month period (the “Rolling Forecast”). OREXIGEN may, at its
discretion, update such Rolling Forecast more frequently. The first three
(3) months of each Rolling Forecast shall constitute a binding order on CHEMI
and OREXIGEN for the quantities of Bupropion Hydrochloride specified therein
(“Firm Commitment”), and the following [* * *] ([* * *]) months of the Rolling
Forecast shall be non-binding estimates and shall be used by CHEMI for planning
purposes only. CHEMI shall be obligated to supply no less than [* * *] percent
([* * *]%) of the quantity of Bupropion Hydrochloride ordered by OREXIGEN
pursuant to any Purchase Order which complies with Section 3.3. Further, CHEMI
agrees to use commercially reasonable efforts to deliver any quantities of
Bupropion Hydrochloride ordered by OREXIGEN which exceed OREXIGEN’s Firm
Commitment by not more than [* * *] percent ([* * *]%) or for which a delivery
date of less than [* * *] ([* * *]) days from the date of such Purchase Order is
requested by OREXIGEN.

 

3.2.

After the Finished Products have received approval for marketing from a
Regulatory Agency (the date of such approval hereinafter referred to as the
“Qualification Date”) and have been made generally commercially available
(hereinafter “Commercial Launch”), CHEMI shall, within [* * *] ([* * *])
business days after OREXIGEN has provided its quarterly forecast, notify
OREXIGEN in writing of any prospective problems CHEMI might have with respect to
supplying OREXIGEN’s forecasted order quantities. Upon receipt of such notice,
the Parties shall promptly discuss the inability to supply the amounts
forecasted by OREXIGEN and work in good faith to agree upon

 

 

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revised forecast amounts. Failing agreement, OREXIGEN’s last submitted forecast
shall be deemed to be the new quarterly forecast. The foregoing notice and
discussion requirements of this Section 3.2 shall not operate to relieve CHEMI
of its obligations pursuant to any Firm Commitment Purchase Order (as defined in
Section 3.3), or affect OREXIGEN’s right to pursue any remedies that may be
available to it.

 

3.3. Prior to the beginning of each calendar quarter, OREXIGEN shall submit a
binding, non-cancelable Purchase Order for the most recent Firm Commitment
portion of the Rolling Forecast for such calendar quarter (“Firm Commitment
Purchase Order”). Each Purchase Order shall specify the quantity of Bupropion
Hydrochloride ordered, the total Price (as defined in Section 5.2) for such
quantities of Bupropion Hydrochloride calculated in accordance with Section 5
hereof, and the required delivery date and destination, consistent with the
terms of this Agreement. OREXIGEN shall submit each Purchase Order to CHEMI at
least [* * *] ([* * *]) days in advance of the delivery date requested in the
Purchase Order. Within [* * *] ([* * *]) business days after the date that a
Purchase Order is submitted, CHEMI shall acknowledge receipt of OREXIGEN’s
Purchase Order and confirm that the amounts of Bupropion Hydrochloride ordered
in the Purchase Order will be timely supplied. For the avoidance of doubt, CHEMI
shall be obligated to accept any such Purchase Order which complies with this
Section 3.3. Notwithstanding the foregoing, any failure by CHEMI to respond to a
Purchase Order within such [* * *] ([* * *]) day period shall be deemed
acceptance of such Purchase Order.

 

3.4. CHEMI agrees to retain a safety stock of Bupropion Hydrochloride to be used
for sale by OREXIGEN based on the average monthly quantities in the Rolling
Forecast. CHEMI will promptly notify OREXIGEN if CHEMI’s manufacturing capacity
will be insufficient to fill a Purchase Order submitted by OREXIGEN.

 

3.5. During any period during this Agreement in which CHEMI, for any reason,
including, without limitation, a force majeure as provided in Section 13.1,
fails to deliver the requisite quantities of Bupropion Hydrochloride included
within any Firm Commitment Purchase Order, within [* * *] ([* * *]) days after
the date of delivery confirmed in writing by CHEMI or if CHEMI otherwise
anticipates or notifies OREXIGEN that it will be unable to make delivery of all
or a portion of the ordered Bupropion Hydrochloride within [* * *] ([* * *])
days after the confirmed date of delivery, then OREXIGEN may refuse such late
shipment of Bupropion Hydrochloride from CHEMI and purchase such quantities
elsewhere. OREXIGEN shall have no further obligations to purchase the
undelivered Bupropion Hydrochloride ordered from CHEMI pursuant to a Firm
Commitment Purchase Order.

 

4. DELIVERY

 

4.1. Each Purchase Order shall specify the quantity of Bupropion Hydrochloride
ordered and the required delivery date and destination, consistent with the
terms of this Agreement.

 

4.2.

Freight and other delivery terms shall be as set forth in Schedule B. Title of
the Bupropion Hydrochloride shall pass from CHEMI to OREXIGEN upon receipt by

 

 

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OREXIGEN or its designated agents of such product at the location specified in
the Purchase Order.

 

4.3. CHEMI shall deliver the complete order amounts on the delivery date
specified in the Purchase Order. CHEMI shall be responsible for coordinating the
export of the Bupropion Hydrochloride to the United States and to OREXIGEN’s
designated Custom Agent in a timely manner and in compliance with the
Specifications and all Applicable Laws. CHEMI shall notify OREXIGEN of the
expected delivery date of the order to enable receipt to be coordinated.

 

4.4. Bupropion Hydrochloride shall be delivered to OREXIGEN’s pursuant to the
terms set forth in Schedule B in CHEMI’s normal packaging and documentation for
Bupropion Hydrochloride, including, without limitation, any such procedures as
reflected in CHEMI’s DMF, provided that such packaging and documentation shall
meet the customs and regulatory requirements within the United States and as
applicable, to the location of OREXIGEN’s designated facility for delivery. Each
shipment shall include certificates of analysis and compliance, which include,
without limitation, a statement of compliance with cGMP, and such other
documentation and information as may be necessary or desirable for complying
with import, export and customs laws, regulations and requirements as
applicable.

 

5. PRICE AND PAYMENT

 

5.1. The price for the Bupropion Hydrochloride to be purchased by OREXIGEN
hereunder is set forth in Schedule B, as adjusted in accordance with this
Section 5 (the “Price”).

 

5.2. The Price shall remain fixed for the first [* * *] ([* * *]) months of the
Agreement, and thereafter shall be adjusted in accordance with this Section 5.2
on [* * *] to take effect for orders to be delivered after such applicable
[* * *]. The Price shall be adjusted based on the [* * *] in [* * *]. The price
[* * *] will be calculated [* * *] months prior to the [* * *] with notification
of said price [* * *] is to be made to OREXIGEN by CHEMI no later than [* * *]
months prior to each [* * *] for implementation on the Effective Date.

 

5.3.

CHEMI and OREXIGEN, as applicable, shall be entitled to adjust the Price at any
time during the term of this Agreement (to take effect for Purchase Orders
accepted after the date of such adjustment) by giving [* * *] ([* * *]) days
prior written notice to the other Party solely to take into account any
documented and verifiable increases or decreases in the [* * *] resulting from
(i) [* * *] (“[* * *] Price Change”), or (ii) changes in [* * *] or [* * *]
(other than as a result of [* * *]) or any changes to [* * *] (“[* * *] Price
Change”). In the event of (i) a [* * *] Price Change, CHEMI and OREXIGEN shall
negotiate in good faith to adjust the Price based on the changes to the [* * *],
and (ii) a [* * *] Price Change, the Price shall be increased by an amount equal
to [* * *] percent ([* * *]%) of [* * *] Price Change, provided that in either
case, if the applicable change results in an increase in the Price payable by
OREXIGEN and OREXIGEN disagrees with CHEMI that the [* * *] changes are
necessary [* * *], then OREXIGEN shall, within [* * *] ([* * *]) days of receipt
of such notice from CHEMI, notify CHEMI in writing of OREXIGEN’s disagreement
and the rationale for such disagreement. The

 

 

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Parties shall thereafter attempt in good faith to agree upon whether such change
is necessary and who shall bear the costs due to such change by negotiation and
consultation between appropriate representatives of each of the Parties. In the
event said representatives are unable to reach a consensus within [* * *]
([* * *]) days, such dispute shall be resolved in accordance with Section 13.3.
CHEMI’s costs to manufacture Bupropion Hydrochloride hereunder shall be
determined from [* * *] on a consistent basis and in accordance with CHEMI’s
standard accounting practices. Reasonably promptly after each [* * *], CHEMI
shall give OREXIGEN written notice of CHEMI’s costs to manufacture Bupropion
Hydrochloride as of such date.

 

5.4. CHEMI shall issue its invoice to OREXIGEN at the time of shipment. Each
invoice shall set forth the applicable Price for the shipment properly
determined in accordance with the provisions of this Agreement. Payment of the
invoice by OREXIGEN shall be within [* * *] ([* * *]) days following receipt of
such invoice. Payment shall be subject to the inspection and acceptance
procedures set forth in Section 6. OREXIGEN may withhold a portion of any
invoice that it disputes in good faith pending resolution of such dispute. All
invoices and payments shall be in U.S. Dollars.

 

6. INSPECTION OF SHIPMENTS

 

6.1. OREXIGEN shall visually inspect or have visually inspected the Bupropion
Hydrochloride delivered hereunder for obvious damage and/or shortage
(collectively, “Obvious Damage”) after receipt thereof and shall provide CHEMI
with written notice of any such Obvious Damage within [* * *] ([* * *]) days
after receipt. OREXIGEN shall be deemed to have accepted any shipment of
Bupropion Hydrochloride, but only with respect to Obvious Damage, unless CHEMI
receives the written notice required within the [* * *] ([* * *])-day time
period specified above. At its discretion, OREXIGEN may also test, or have
tested, any lot of Bupropion Hydrochloride supplied to OREXIGEN.

 

6.2. At any time within [* * *] ([* * *]) months after receipt of any lot of
Bupropion Hydrochloride but within [* * *] ([* * *]) days after discovery,
OREXIGEN may provide CHEMI with written notice of any non-obvious damage,
including adulteration of the Bupropion Hydrochloride, failure to meet
Specifications, or other latent damage or defect (collectively, “Non-Obvious
Damage”). Obvious Damage and Non-Obvious Damage shall hereinafter be
collectively referred to as “Damage.”

 

6.3. OREXIGEN may reject any portion of any shipment of Bupropion Hydrochloride
which contains any Damage by providing written notice to CHEMI of its rejection.
OREXIGEN agrees to provide CHEMI’s Quality Control Department with documentation
of Damage to confirm the existence thereof in connection with any notice of
rejection.

 

6.4.

If CHEMI and OREXIGEN disagree as to the existence of Damage, then they will
diligently and in good faith repeat the analyses of samples from the shipment in
question and implement suitable controls to determine the source of the
discrepancy in results and the cause of any detected Damage, applying all
objective and sound principles of

 

 

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scientific investigation. If after such repeated analyses the disagreement is
not resolved within [* * *] ([* * *]) days after the date of OREXIGEN’s notice,
the Parties will then submit representative samples of the shipment to a
mutually acceptable independent testing lab and the results of said lab shall be
binding on CHEMI and OREXIGEN. The costs associated with such submission shall
be borne by the Party against which the lab decided.

 

6.5. Provided OREXIGEN provides notice of the damage claimed within [* * *]
([* * *]) days of receipt of the allegedly Damaged Bupropion Hydrochloride in
the case of Obvious Damage and within [* * *] ([* * *]) days after discovery,
and in any case within [* * *] ([* * *]) months of receipt of the allegedly
Damaged Bupropion Hydrochloride in the case of Non-Obvious Damage, whether or
not CHEMI accepts OREXIGEN’s basis for rejection, CHEMI shall promptly, on
receipt of a notice of rejection and/or shortage, at OREXIGEN’s request and at
no additional cost to OREXIGEN (including, without limitation, the cost of
transportation, export or import duties, if any, taxes, insurance and handling
costs), deliver to OREXIGEN quantities of replacement Bupropion Hydrochloride
equal to the rejected or short quantities as soon as reasonably practicable
thereafter, and in no event more than [* * *] ([* * *]) days after such notice
is given and OREXIGEN shall have no obligation to pay for such Bupropion
Hydrochloride until such time as conforming replacement Bupropion Hydrochloride
has been received. CHEMI will use expedited means of transport, if so requested
by OREXIGEN at OREXIGEN’s expense unless such Bupropion Hydrochloride being
replaced is determined to have been damaged.

 

6.6. Notwithstanding any other provisions of this Agreement, OREXIGEN agrees, if
so requested by CHEMI, to return to CHEMI, at CHEMI’s expense, any Bupropion
Hydrochloride that is, or is claimed to be, Damaged or otherwise to dispose of
such Bupropion Hydrochloride as CHEMI may request.

 

7. CONFIDENTIALITY

 

7.1. During the term of this Agreement, the Parties may disclose certain
confidential and proprietary information and data to each other relating to
their respective products, including active pharmaceutical ingredients and
Finished Products (“Products”) and businesses, including, but not limited to
financial and other business information, Product samples, formulas,
manufacturing processes, specifications, drawings, schematics and other
technical, customer and Product development plans, forecasts, strategies and
other data. Except as otherwise specifically provided herein, all information
disclosed by one Party (in such capacity, the “Disclosing Party”) to the other
Party (in such capacity, the “Receiving Party”) relating to the Disclosing
Party’s Products and/or its business operations and the results, reports, etc.,
of testing and evaluation of any such information shall constitute “Proprietary
Information.”

 

7.2. Proprietary Information disclosed by a Disclosing Party to a Receiving
Party hereunder shall be used by the Receiving Party solely in connection with
exercising its rights or performing its obligations under this Agreement.

 

 

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7.3. In consideration of the Disclosing Party’s disclosure and supply of
Proprietary Information, each Party, as a potential Receiving Party, agrees
that, for the term of the Agreement and for a period of [* * *] ([* * *]) years
thereafter, it shall use the Disclosing Party’s Proprietary Information
exclusively to conduct the activities contemplated under this Agreement. Each
Party further agrees, as a potential Receiving Party, for the term of the
Agreement and for a period of [* * *] ([* * *]) years thereafter, it shall not
disclose, without the express written consent of the Disclosing Party, any
Proprietary Information, including this Agreement or the interest of the
Disclosing Party in exploring the possibility of entering into a business
relationship with the Receiving Party, to any person other than to those
employees, consultants or agents of the Receiving Party (“Representatives”) who
will be directly involved in fulfilling the Receiving Party’s obligations under
this Agreement, provided that such Representatives have assumed like obligations
of confidentiality in writing to the Disclosing Party. Notwithstanding the
foregoing, (a) OREXIGEN may disclose the existence and terms of this Agreement
to bona fide potential investors, acquirers, corporate partners and financial
advisors and (b) CHEMI may disclose the existence (but not the terms of) this
Agreement to bona fide potential investors and financial advisors.

 

7.4. Each Party, as a potential Receiving Party, agrees to advise those of its
Representatives who receive Proprietary Information (and such other persons who
may receive Proprietary Information as permitted by 7.3(a) or 7.3(b) above) that
such information (a) is proprietary and confidential to the Disclosing Party and
(b) shall not be disclosed to anyone except as authorized herein. Each Party
further agrees to take such reasonable precautions as it normally takes with its
own confidential and proprietary information to prevent unauthorized disclosure
or use of such Proprietary Information.

 

7.5. In the event that the Receiving Party is required by any government
regulation, law, court order or rule or otherwise becomes legally compelled to
disclose any Proprietary Information, it will provide the Disclosing Party with
prompt advance notice in writing so that the Disclosing Party may, at its
discretion, reasonably intervene prior to disclosure. The Receiving Party shall
disclose only that portion of Proprietary Information which its legal counsel
determines it is required to disclose and will exercise its commercially
reasonable efforts to obtain reliable assurance that confidential treatment will
be accorded to such Proprietary Information.

 

7.6.

Notwithstanding any of the foregoing, the term “Proprietary Information” and the
obligation of confidentiality associated therewith shall not apply to the
following information: (a) information which, at the time of the Disclosing
Party’s disclosure to the Receiving Party, is publicly known; (b) information
which, after the Disclosing Party’s disclosure to the Receiving Party, becomes
publicly known, except where such knowledge is the result of the Receiving
Party’s breach of this Agreement or otherwise is the result of any unauthorized
disclosure by any of its employees or Representatives; (c) information which,
prior to the Disclosing Party’s disclosure to the Receiving Party, was already
in the Receiving Party’s possession, as evidenced by its prior written records;
or (d) information which, subsequent to the Disclosing Party’s disclosure to the
Receiving Party, is obtained by the Receiving Party from a third Party which is
lawfully in possession of such information and not subject to a contractual or
fiduciary relationship

 

 

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to the Disclosing Party with respect thereto; or (e) information which was
independently developed by or for Receiving Party by an individual without
access to, reference of, incorporation of or use of the Proprietary Information,
but in any event, without violating the terms of this Agreement.

 

7.7. Upon the termination of this Agreement, the Receiving Party shall, if so
requested by the Disclosing Party, promptly return to the Disclosing Party the
originals and all copies of any Proprietary Information then in the Receiving
Party’s possession. Notwithstanding the foregoing, Receiving Party may retain
one copy of such Proprietary Information for archival purposes.

 

8. QUALITY OF BUPROPION HYDROCHLORIDE; REGULATORY MATTERS; REPRESENTATIONS AND
WARRANTIES

 

8.1. CHEMI hereby represents, warrants and covenants as follows:

 

  8.1.1. At all times during the term of this Agreement, CHEMI’s facilities
shall remain in compliance with, and the Bupropion Hydrochloride shall be
manufactured and delivered in compliance with, all applicable laws, regulations
and standards, including but not limited to, the provisions of the Federal Food,
Drug, and Cosmetic Act, as amended from time to time (the “Act”); the FDA’s
cGMP, including the FDA’s Guidance for Industry, Manufacturing, Processing or
Holding Active Pharmaceutical Ingredients, March 1998, and any updates thereto;
the FDA’s regulations for drug establishment registration; the Specifications;
the other rules and regulations promulgated under the Act relating to the
manufacture of pharmaceutical products; and equivalent laws, regulations and
standards promulgated by Regulatory Agencies in all jurisdictions for which
OREXIGEN has given notice to CHEMI (collectively, the “Applicable Laws”).

 

  8.1.2. No Bupropion Hydrochloride constituting or being a part of any shipment
to OREXIGEN shall at the time of any such shipment be adulterated within the
meaning of the Act, or the rules and regulations promulgated there under, as
such law, rule or regulation is constituted and in effect at the time of any
such shipment.

 

  8.1.3. All Bupropion Hydrochloride supplied to OREXIGEN hereunder (i) shall
comply with the Specifications; (ii) shall have been manufactured, stored and
shipped in accordance with the Specifications, applicable approvals from
Regulatory Agencies and all Applicable Laws, (iii) may be introduced into public
commerce consistent with the intended use for Bupropion Hydrochloride pursuant
to Applicable Laws, and (iv) will have expiration dating of not less than thirty
(30) months from the date of delivery in accordance with this Agreement.

 

  8.1.4. All necessary licenses, permits or approvals required by Applicable
Laws in connection with the manufacture, storage, and shipment of Bupropion
Hydrochloride hereunder, including without limitation permits related to
manufacturing facilities shall be obtained and maintained.

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  8.1.5. CHEMI will (i) respond fully and accurately to all inquiries directed
to it by the FDA or any other Regulatory Agency that may impact the quality or
timely delivery of Bupropion Hydrochloride and shall promptly notify OREXIGEN of
same, (ii) assist OREXIGEN in responding to inquiries directed to OREXIGEN by
the FDA or other Regulatory Agencies, and (iii) provide the FDA or other
Regulatory Agencies with such information and data as is requested by the FDA or
other Regulatory Agencies with respect to the manufacture, use, route of
synthesis and testing of the Bupropion Hydrochloride.

 

  8.1.6. CHEMI’s manufacturing facilities are, and shall at all times during the
term of this Agreement be, in compliance with the FDA’s cGMP.

 

  8.1.7. CHEMI has disclosed to OREXIGEN all warning letters or similar notices
relating to its manufacturing facilities or import alerts (including FDA Form
483’s), if any, for products manufactured in its facilities issued during the
last five (5) years and CHEMI will during the term disclose in timely fashion
all such letters, alerts and notices.

 

  8.1.8. CHEMI has, and shall maintain, sufficient facilities, personnel and
resources to meet its obligations to supply Bupropion Hydrochloride under this
Agreement.

 

  8.1.9. CHEMI is not aware of any claim by a third party that the Bupropion
Hydrochloride supplied hereunder or its process for manufacturing the Bupropion
Hydrochloride supplied hereunder would, if carried out in the United States, or
in any other country where generic Bupropion Hydrochloride is manufactured or
sold, infringe, misappropriate or violate any patent, trade secret or other
intellectual property right in effect in such countries.

 

  8.1.10. To CHEMI’s knowledge ([* * *]), the Bupropion Hydrochloride supplied
to OREXIGEN under this Agreement and CHEMI’s process for manufacturing the
Bupropion Hydrochloride supplied hereunder will not infringe, misappropriate or
violate any patent, trade secret or other intellectual property right in effect
during the term of this Agreement in the United States.

 

  8.1.11. There are no pending or threatened claims against CHEMI asserting that
any of the activities of CHEMI relating to the manufacture, import, use and sale
of Bupropion Hydrochloride in the United States or the conduct of the activities
contemplated herein by OREXIGEN, infringe, misappropriate or violate the rights
of any third party.

 

8.2. OREXIGEN hereby represents, warrants and covenants that, to OREXIGEN’s
knowledge ([* * *]), the Finished Product will not infringe, misappropriate or
violate any third party patent, trade secret or other intellectual property
right in effect during the term of this Agreement in the United States
(provided, that OREXIGEN’s representation does not extend to any infringement,
misappropriation or violation that arises out of or relates to the Bupropion
Hydrochloride or the process for manufacturing the Bupropion Hydrochloride).

 

 

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8.3. Each Party represents and warrants that all corporate action on its part
and on the part of each of its officers and directors necessary for the
authorization, execution and delivery of this Agreement has been taken, it has
the full right and authority to enter into this Agreement and perform its
obligations hereunder and that it is not aware of any obligations owed to third
parties that would conflict with its ability to perform its obligations
hereunder.

 

8.4. If requested in writing by OREXIGEN, CHEMI shall permit OREXIGEN or its
authorized representatives to inspect CHEMI’s facilities and records and be
given access to CHEMI’s personnel (at reasonable times, upon reasonable advance
notice and in the company of a CHEMI representative during normal business
hours), to the extent OREXIGEN deems reasonably necessary to enable OREXIGEN to
verify compliance by CHEMI with its obligations under this Agreement and to
verify compliance with any Applicable Laws.

 

8.5. CHEMI shall provide to OREXIGEN yearly confirmation that it has timely
filed with the FDA and all other relevant Regulatory Agencies, any required
DMF-related filings.

 

8.6. OREXIGEN shall provide CHEMI copies of product complaints, or notices or
inquiries from the FDA or other Regulatory Agencies, which raise issues with
respect to the manufacture or product quality of the Bupropion Hydrochloride
provided by CHEMI to OREXIGEN. CHEMI shall fully and appropriately investigate
such matters and provide OREXIGEN with a report of its investigation. In the
event that CHEMI receives any complaint, claims or adverse reaction reports
regarding Bupropion Hydrochloride, including notices from the FDA regarding any
alleged regulatory noncompliance of Bupropion Hydrochloride, CHEMI shall
promptly and not more than [* * *] ([* * *]) business days after receipt,
provide to OREXIGEN all information contained in the complaint, report or notice
and such additional information regarding Bupropion Hydrochloride as OREXIGEN
may reasonably request. CHEMI shall comply, at a minimum, with FDA requirements
for complaint handling with respect to such complaints, claims or adverse
reaction reports.

 

8.7. OREXIGEN and CHEMI each further represents and warrants, for itself, that
it shall comply with all Applicable Laws in the performance of its obligations
hereunder.

 

8.8.

CHEMI shall promptly notify OREXIGEN of any problems or unusual production
situations which have, or are reasonably likely to have, an adverse effect on
CHEMI’s ability to perform its obligations hereunder or to deliver the Bupropion
Hydrochloride to OREXIGEN in a timely manner. CHEMI will make its facilities
available for inspection by representatives of any Regulatory Agency in
compliance with all Applicable Laws. In addition, CHEMI shall notify and, if
applicable, provide copies of any notices or communications to, OREXIGEN of any
FDA or other Regulatory Agency inspection, investigation or other inquiry or
communication relating to the manufacture of the Bupropion Hydrochloride or to
any facility at which the Bupropion Hydrochloride is manufactured, including,
but not limited to, any FDA FORM 483 or warning letter, promptly and not more
than [* * *] ([* * *]) business days after shall also discuss with OREXIGEN any
response to observations and notifications received in connection with

 

 

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any inspection, investigation, communication or other inquiry concerning
Bupropion Hydrochloride and will give OREXIGEN an opportunity to comment upon
any proposed response before it is made. Any notices under this Section 8.8
shall not operate to relieve CHEMI of its obligations to deliver the ordered
amounts of Bupropion Hydrochloride or affect OREXIGEN’s right to pursue any
remedies that might be available to it.

 

8.9. Both Parties covenant that it will not in the performance of its
obligations under this Agreement use the services of any person debarred or
suspended under 21 U.S.C. §35(a) or (b). Both Parties represent that it does not
currently have, and covenants that it will not hire, as an officer or an
employee, any person who has been convicted of a felony under the laws of the
United States for conduct relating to the regulation of any drug product under
the Act.

 

8.10. Both Parties shall maintain commercial general liability insurance and
product liability insurance with a minimum limit per occurrence or accident of
$[* * *] and an annual aggregate limit of $[* * *] for the term of this
Agreement and for [* * *] ([* * *]) years thereafter. Upon request, either Party
will provide to the other Party copies of insurance certificates reflecting the
above.

 

8.11. CHEMI shall immediately notify OREXIGEN of any information of the
following kind about Bupropion Hydrochloride provided to OREXIGEN:

 

  8.11.1. information indicating that shipped product has not been manufactured
or supplied in accordance with the Specifications, cGMP, this Agreement or in
compliance with Applicable Laws; and

 

  8.11.2. information concerning any bacteriological contamination, or any
significant chemical, physical or other changes or deterioration in the shipped
Bupropion Hydrochloride, or the failure of one or more shipped lots of Bupropion
Hydrochloride to meet Specifications, including stability parameters.

 

8.12. Without limiting the foregoing, the Parties shall enter into a Quality
Agreement within six (6) months of the date of the execution of this Agreement
(the “Quality Agreement”). In the event there is any conflict in the terms and
provisions of this Agreement and the Quality Agreement, the terms and provisions
of this Agreement shall control and prevail.

 

8.13. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NO PARTY MAKES ANY
WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, AND EACH PARTY
SPECIFICALLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.

 

 

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9. INDEMNIFICATION

 

9.1. OREXIGEN hereby agrees to and shall defend, indemnify, and hold harmless
CHEMI, its affiliates and each of their respective employees, officers,
directors and agents (the “Supplier Indemnitees”), from, against, and in respect
of, any and all losses, judgments, damages, liabilities, suits, actions,
expenses (including reasonable attorney’s fees), and proceedings arising from
any claims of any third party to the extent resulting from:

 

  9.1.1. any misrepresentation, breach of warranty, or the non-fulfillment of
any obligation, covenant, or duty on the part of OREXIGEN under this Agreement;

 

  9.1.2. any claim, complaint, suit, proceeding or cause of action against any
of the Supplier Indemnitees alleging physical injury or death, brought by or on
behalf of an injured party, or loss of service or consortium or a similar such
claim, complaint, suit, proceeding or cause of action brought by a spouse,
relative or companion of an injured party due to such physical injury or death,
and in each case arising out of the Finished Products;

 

  9.1.3. any negligence or willful misconduct of OREXIGEN, its employees,
officers and directors in performing this Agreement; and

 

  9.1.4. any claim of patent infringement relating to a Finished Product or the
process for manufacturing a Finished Product (excluding any claim of patent
infringement arising out of or relating to the Bupropion Hydrochloride or the
process for manufacturing the Bupropion Hydrochloride), which claim, if true,
would be in contravention of the representations, warranties and covenants of
OREXIGEN hereunder;

Except to the extent resulting from (i) any misrepresentation, breach of
warranty, or the non-fulfillment of any obligation, covenant, or duty on the
part of CHEMI under this Agreement, (ii) any negligence or willful misconduct of
the Supplier Indemnitees in performing this Agreement, or (iii) any claim
subject to CHEMI’s indemnification obligations under Section 9.2.

 

9.2. CHEMI hereby agrees to and shall defend, indemnify, and hold harmless
OREXIGEN, its affiliates and each of their respective employees, officers,
directors and agents (the “OREXIGEN Indemnitees”), from, against, and in respect
of, any and all losses, judgments, damages, liabilities, suits, actions,
expenses (including reasonable attorney’s fees), and proceedings arising from
any claims of any third party to the extent resulting from:

 

  9.2.1. any misrepresentation, breach of warranty, or the nonfulfillment of any
obligation, covenant, or duty on the part of CHEMI under this Agreement;

 

  9.2.2. any claim, complaint, suit proceeding or cause of action against any of
the OREXIGEN Indemnitees alleging physical injury or death, brought by or on
behalf of an injured party, or loss of service or consortium or a similar such
claim, complaint, suit, proceeding or cause of action brought by a spouse,
relative or

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companion of an injured party due to such physical injury or death, and in each
case arising out of the Bupropion Hydrochloride supplied by CHEMI to OREXIGEN;

 

  9.2.3. any negligence or willful misconduct of CHEMI or its employees,
officers or directors in performing this Agreement; and

 

  9.2.4. any claim of patent infringement relating to the Bupropion
Hydrochloride supplied to OREXIGEN or the process for manufacturing the
Bupropion Hydrochloride supplied to OREXIGEN which claim, if true, would be in
contravention of the representations, warranties and covenants of CHEMI
hereunder;

Except to the extent resulting from (i) any misrepresentation, breach of
warranty, or the non-fulfillment of any obligation, covenant, or duty on the
part of OREXIGEN under this Agreement, (ii) any negligence or willful misconduct
of the OREXIGEN Indemnitees in performing this Agreement, or (iii) any claim
subject to OREXIGEN’s indemnification obligations under Section 9.1.

 

9.3.

The foregoing indemnification obligations are subject to the following: (a) the
indemnifying Party must be notified by or on behalf of the indemnified Party in
writing promptly after a claim is made, a suit is filed or an action or
investigation is initiated (each, a “Proceeding”) against the indemnified Party,
unless such delay does not materially prejudice the indemnifying Party;
(b) subject to the provisions set forth below in this Section 9.3, the
indemnifying Party shall be permitted to defend, control, conduct and prosecute,
in the indemnifying Party’s sole discretion and by counsel of the indemnifying
Party’s choosing, the defense of such Proceeding brought against the indemnified
Party; (c) the indemnifying Party shall have the right in its sole discretion to
settle, compromise or otherwise terminate the Proceeding solely upon the payment
of money; provided, that, there is no finding or admission of any violation by
any indemnified Party of (i) any law, rule or regulation or (ii) the rights of
any person; and provided, further, that, no such settlement shall prohibit any
indemnified Party from importing the Bupropion Hydrochloride into the United
States and or making, using or selling products in the United States and made
from such Bupropion Hydrochloride; (d) the indemnified Party shall refrain from
settling (or endeavoring to settle, or entering into settlement negotiations
with respect to) any such Proceeding without the indemnifying Party’s prior
written consent; (e) except as may otherwise be required by law, the indemnified
Party shall not compromise the position of the indemnifying Party by admission,
statements, disclosure or conduct (collectively, “Disclosure”) in a way that
could prejudice the defense, control, conduct or prosecution of said cause of
action (it being understood that no indemnified Party shall be deemed to have
violated this provision so long as such Party has acted in good faith to fulfill
its obligations under this provision); and (f) the indemnified Party shall
cooperate with the indemnifying Party in the defense, conduct, prosecution or
termination of the Proceeding, including the furnishing of information and the
assistance from employees of the indemnified Party at the indemnifying Party’s
reasonable request and expense. With respect to clause (e) above, the
indemnified Party will provide the indemnifying Party with prompt written notice
in advance of any such Disclosure being made to permit the indemnifying Party to

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seek an appropriate protective order, restriction on response or withdrawal of
the request for Disclosure. If, however, any such request for relief by the
indemnifying Party is denied or is otherwise unavailable, the relevant
indemnified Party may make the Disclosure without any liability to the
indemnifying Party. The indemnified Party may, at its option and expense,
participate in the indemnifying Party’s defense with counsel of its own
choosing, and if the indemnified Party so participates, the Parties shall
cooperate with one another in such defense in a commercially reasonable fashion.
Notwithstanding any provision in this Agreement to the contrary, OREXIGEN shall
at all times have the right to assume direction and control of the defense of
any claim alleging infringement, misappropriation or violation of any patent,
trade secret or other intellectual property right of any third party, provided
that OREXIGEN will provide CHEMI with a reasonable opportunity to review and
consult from time to time concerning the strategy and action plan (including
possibly pursuing one or more licenses as appropriate), and in such event CHEMI
shall cooperate and assist as requested in the defense of such claim and if
OREXIGEN finds it necessary or desirable to join CHEMI as a party, CHEMI shall
execute all papers or perform such other acts as may reasonably be required by
OREXIGEN. Further, CHEMI shall not settle or consent to the entry of any
judgment with respect to any such claim, without OREXIGEN’s prior written
consent. In the event OREXIGEN assumes the direction and control of the defense
of any claim alleging infringement, misappropriation or violation of any patent,
trade secret or other intellectual property rights of any third party, [* * *]
in connection with the defense of such claim.

 

9.4. The indemnification rights provided for herein are in addition to, and not
in substitution for, any and all remedies available to a Party under this
Agreement or otherwise at law or in equity. Notwithstanding anything to the
contrary in this Section 9, each Party may, and expressly reserves the right to,
seek judicial relief from any court of competent jurisdiction in order to obtain
an injunction or other equitable relief.

 

9.5. IN NO EVENT SHALL ANY OF THE PARTIES HERETO BE RESPONSIBLE OR LIABLE TO THE
OTHER UNDER ANY PROVISION OF THIS AGREEMENT OR UNDER ANY THEORY OF NEGLIGENCE,
STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY CONSEQUENTIAL,
INDIRECT, SPECIAL, OR EXEMPLARY DAMAGES OR LOST PROFITS. FOR THE PURPOSE OF
CLARITY, NOTHING IN THIS SECTION IS INTENDED TO LIMIT THE INDEMNIFICATION
OBLIGATIONS OF ANY PARTY WITH RESPECT TO THE CHARACTERIZATION OF ANY CLAIM BY A
THIRD PARTY AS CONSEQUENTIAL, INDIRECT, SPECIAL, OR EXEMPLARY DAMAGES OR LOST
PROFITS.

 

10. ADVERSE EVENT REPORTING; COSTS AND EXPENSES OF RECALL

 

10.1.

OREXIGEN shall have sole control and responsibility for reporting all adverse
events associated with the use of Finished Products in humans, whether expected
or unexpected and whether or not considered drug related, including the
following: (i) an adverse event occurring in the course of the use of a drug
product in professional practice; (ii) an adverse event occurring from drug
overdose whether accidental or intentional; (iii) an

 

 

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adverse event occurring from drug abuse; or (iv) an adverse event occurring from
drug withdrawal; and any failure of expected pharmacological action
(collectively, “Adverse Events”), with respect to the Finished Products, and
responding to all Finished Product quality complaints and medical and technical
inquiries, whether from lay persons, health care professionals and or Regulatory
Agencies. Notwithstanding the foregoing, to the extent CHEMI has an obligation
to report any Adverse Events to any Regulatory Agencies it may do so provided it
first provides written notice to OREXIGEN thereof and a copy of such report.
CHEMI agrees to consider in good faith any comments OREXIGEN has timely provided
concerning such reports prior to CHEMI’s submission of the same to the
applicable Regulatory Agency. In the event CHEMI (a) receives any information
regarding any Adverse Event relating to Bupropion Hydrochloride or any Finished
Products or their manufacture, (b) receives any complaints relating, or
potentially relating, to Bupropion Hydrochloride or any Finished Products or
their manufacture, (c) receives any medical or technical inquiry relating, or
potentially relating, to Bupropion Hydrochloride or any Finished Products or
their manufacture, or (d) discovers or is notified of any material defect in
Bupropion Hydrochloride or any Finished Products, it shall (i) notify OREXIGEN
within [* * *] ([* * *]) days thereof, and (ii) promptly conduct an
investigation in accordance with its approved written procedures for the
surveillance, receipt, evaluation, and reporting of complaints, inquiries or
discoveries of that nature and report the results of such investigation to
OREXIGEN promptly upon the completion thereof.

 

10.2. OREXIGEN shall have sole control and responsibility for conducting all
voluntary and involuntary recalls or other related action (collectively,
“Recalls”) of units of any Finished Product; provided, however, that CHEMI
agrees to reimburse OREXIGEN for all of its reasonable costs and expenses
incurred with respect to any Recalls arising out of any of the causes set forth
in Sections 9.2.1 through 9.2.4. Further, in the event of any Recall of any
Finished Products arising out of any of the causes set forth in Sections 9.2.1
through 9.2.4, OREXIGEN’s obligation to pay CHEMI for Bupropion Hydrochloride
purchased hereunder shall cease. This Section 10 is intended to augment and not
limit the indemnification provisions of Section 9 herein.

 

11. TERM AND TERMINATION

 

11.1. This Agreement shall commence on the Effective Date and shall continue in
effect until the date that is four (4) years from the Qualification Date (the
“Initial Term”), unless earlier terminated or extended in accordance with it
terms. This Agreement shall be automatically renewed for additional two (2) year
terms unless written notice of intent to terminate is provided by OREXIGEN at
least three (3) months prior to the expiration of the Initial Term or any
extension term, as applicable.

 

11.2.

This Agreement may be terminated by (i) OREXIGEN upon [* * *] ([* * *]) days
written notice to CHEMI of a failure by CHEMI to perform or observe any material
covenant, condition or agreement to be performed or observed by it under this
Agreement, unless such breach has been cured within the [* * *] ([* * *])-day
notice period, and (ii) CHEMI upon [* * *] ([* * *]) days written notice to
OREXIGEN of a failure by OREXIGEN to perform or observe any material covenant,
condition or agreement to be performed or observed by it under this Agreement,
unless such breach has been cured within the [* * *] ([* * *])-day notice
period; provided, however, that with respect to a failure to timely

 

 

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supply ordered quantities of Bupropion Hydrochloride under this Agreement, CHEMI
shall have the right to cure such breach no more than once during the term of
this Agreement unless otherwise agreed by OREXIGEN in writing; and provided
further, that if the breach by OREXIGEN is a failure to pay an invoice when due
(except as provided in Section 5.8), then the notice and cure period shall be [*
* *] ([* * *]) days.

 

11.3. OREXIGEN may terminate this Agreement effective immediately upon written
notice to CHEMI in the event that (a) CHEMI dissolves, is declared insolvent or
bankrupt by a court of competent jurisdiction; (b) a voluntary or involuntary
petition of bankruptcy is filed in any court of competent jurisdiction by CHEMI;
or (c) this Agreement is assigned by CHEMI for the benefit of creditors. CHEMI
may terminate this Agreement effective immediately upon written notice to
OREXIGEN in the event that (a) OREXIGEN dissolves, is declared insolvent or
bankrupt by a court of competent jurisdiction; (b) a voluntary or involuntary
petition of bankruptcy is filed in any court of competent jurisdiction by
OREXIGEN; or (c) this Agreement is assigned by OREXIGEN for the benefit of
creditors.

 

11.4. Either Party may terminate this Agreement effective immediately upon
written notice to the other Party in the event that (a) any Regulatory Agency
takes any action, or raises any objection, that prevents OREXIGEN from
importing, exporting, purchasing or selling either the Bupropion Hydrochloride
or the Finished Product (b) the Finished Product fails during clinical trials
and OREXIGEN withdraws its NDA; (c) OREXIGEN determines, in its sole discretion,
to no longer pursue the development and/or commercialization of a Finished
Product which contains Bupropion Hydrochloride; or (d) a legal proceeding shall
be instituted against CHEMI, which is reasonably likely to materially adversely
affect CHEMI’s ability to properly perform under this Agreement or subject
OREXIGEN to any material risk of liability or loss.

 

11.5. In the event of termination of this Agreement by OREXIGEN pursuant to
Section 11.4, OREXIGEN agrees to pay for previously placed orders of Bupropion
Hydrochloride but not yet delivered to OREXIGEN, provided that CHEMI shall use
reasonable commercial efforts to mitigate the amount of such payments by
OREXIGEN, including, but not limited to, selling such Bupropion Hydrochloride to
other customers, and provided further that CHEMI shall deliver Bupropion
Hydrochloride pursuant to such orders in accordance with this Agreement.

 

11.6. The provisions of this Section 11 as to termination shall not limit or
restrict the rights of any Party to seek remedies or take measures that may be
otherwise available to it at law or equity in connection with the enforcement
and performance of obligations under this Agreement.

 

12. NOTICES

Any and all notices required to be given under this Agreement will be in writing
and effective upon receipt, sent by facsimile transmission, mailed postage
prepaid by first-class certified or registered mail, or sent by express courier
service, at the respective addresses, as follows:

 

 

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IF TO OREXIGEN, TO:

Orexigen Therapeutics, Inc.

3344 N. Torrey Pines Court

Suite 200

La Jolla, CA 92037

Attention: Walt Piskorski

Telephone Number: (858) 875-8600

Facsimile Number: (858) 875-8650

With a copy to:

Orexigen Therapeutics, Inc.

3344 N. Torrey Pines Court

Suite 200

La Jolla, CA 92037

Attention: General Counsel

Telephone Number: (858) 875-8600

Facsimile Number: (858) 875-8650

With an additional copy to (which shall not by itself constitute notice):

Latham & Watkins LLP

12636 High Bluff Drive, Suite 400

San Diego, CA 92130

Attention: Cheston J. Larson, Esq.

Telephone Number: (858) 523-5400

Facsimile Number: (858) 523-5450

IF TO CHEMI, TO:

CHEMI S.p.A.

Via dei Lavoratori, 54

20092 Cinisello Balsamo (Milan) Italy

Attention: Mr. Paolo Oligeri

Telephone Number: +39 02 64431

Facsimile Number: +39 02 6128960

 

13. MISCELLANEOUS

 

13.1.

Force Majeure. In the event that any Party hereto is prevented from complying,
either in whole or in part, with any of the terms or provisions of this
Agreement by reason of fire, flood, storm, strike or lockout, riot, war,
rebellion, lack or failure of transportation facilities, court order, accident,
or Acts of God, and to the extent that the foregoing are

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beyond a Party’s reasonable control, then, unless conclusive evidence to the
contrary is provided, upon written notice by the Party whose performance is so
affected to the other,

the requirements of this Agreement so affected (to the extent affected) shall be
suspended during the period of, and only to the extent of, such disability. Said
Party shall be excused by reason of said force majeure only so long as it is
exercising its best efforts to overcome said reason. Notwithstanding the
foregoing, if a force majeure event prevents a Party’s performance under this
Agreement for an aggregate of more than [* * *] days, the other Party may
terminate this Agreement upon written notice to the non-performing Party.

 

13.2. Assurances. Each Party to this Agreement shall execute, acknowledge and
deliver such further instruments and documents, and do all such other acts and
things as may be required by law or as may be necessary or advisable to carry
out the intents and purposes of this Agreement. The Parties will cooperate with
each other and offer reasonable assistance in carrying out their respective
responsibilities under this Agreement.

 

13.3. Governing Law and Exclusive Jurisdiction. This Agreement shall be governed
by and construed under the laws of the State of California (USA), excluding its
conflicts of law provisions. Exclusive jurisdiction and venue for any legal
actions or proceedings relating to or arising from this Agreement shall be
vested with the federal and state courts located in the City and County of San
Francisco in the State of California (USA).

 

13.4. Severability. If any provision of this Agreement shall be held to be
invalid, illegal, or unenforceable, the validity, legality, or enforceability of
the remaining provisions hereof shall not in any way be affected or impaired
thereby unless the purposes of the Agreement cannot be achieved. In the event
any provision shall be held invalid, illegal, or unenforceable the Parties shall
use best efforts to substitute a valid, legal, and enforceable provision which
insofar as practical implements the purposes hereof.

 

13.5. No Assignment. No Party shall assign its rights and/or obligations under
this Agreement without the prior written consent of the other Party hereto,
except that either Party may assign this Agreement in connection with the
transfer, license or sale of all or substantially all of its assets or business
to which the subject matter of this Agreement relates or in connection with any
merger, consolidation or reorganization, without the other Party’s prior written
consent.

 

13.6. Waiver. No delay, waiver, omission or forbearance on the part of any Party
to exercise any right, option, duty or power arising out of any breach or
default by any other Party of any of the terms, provisions or covenants hereof,
will constitute a waiver by such Party of its rights to enforce any such right,
option, duties or power as against the other Party hereto, or its rights as to
any subsequent breach or default by the other Party.

 

13.7. Survival. Upon termination or expiration of this Agreement, the
obligations of the Parties which by their nature should survive and the
obligations under Sections 7-13 of this Agreement and under any existing
confidentiality agreements between the Parties shall survive.

 

 

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13.8. Entire Agreement. This Agreement and the Schedules and Appendices attached
hereto, the confidentiality agreements referenced in Section 13.8 and the
Quality Agreement constitute the full understanding and entire agreement between
the Parties and supersede any and all prior oral or written understandings and
agreements with respect to the subject matter hereof. No terms, conditions,
understandings, or agreements purporting to modify, amend, waive or terminate
this Agreement, or any provision hereof, shall be binding except by the
execution of a writing specified to be an explicit amendment to this Agreement
duly executed by the authorized signatories of the Parties hereto. No
modification, waiver, termination, rescission, discharge or cancellation of any
right or claim under this Agreement shall affect the right of any Party to
enforce any other claim or right hereunder.

 

13.9. Binding Agreement. Subject to Section 13.6, this Agreement shall be
binding upon the Parties and their respective successors and permitted assigns
and shall insure to the benefit of the Parties and their respective successors
and permitted assigns.

 

13.10. Headings. The headings used in this Agreement are for convenience of
reference only and are not a part of the text hereof.

 

13.11. Counterparts. This Agreement may be executed in counterparts, each of
which shall constitute an original and all of which shall together constitute a
single agreement.

[Remainder of This Page Intentionally Left Blank]

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IN WITNESS WHEREOF, the Parties hereby agree to the terms and conditions of this
Agreement.

 

OREXIGEN THERAPEUTICS, INC.     CHEMI S.P.A. By:  

 

    By:  

 

Name:   Walter Piskorski     Name:  

 

Title:   Vice President, Technical Operations     Title:  

 

Date:   December 15, 2009     Date:  

 

[SIGNATURE PAGE TO BUPROPION HYDROCHLORIDE SUPPLY AGREEMENT]

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LIST OF DEFINED TERMS

 

DEFINED TERM

  

SECTION

Act

   8.1.1

Adverse Events

   10.1

Agreement

   Preamble

ANDA

   2.3

Applicable Laws

   8.1.1

cGMP

   2.4

CHEMI

   Preamble

Commercial Launch

   3.2

Damage

   6.2

Disclosing Party

   7.1

Disclosure

   9.3

DMF

   2.1

Effective Date

   Preamble

FDA

   2.1

Finished Products

   2.1

Firm Commitment

   3.1

Firm Commitment Purchase Order

   3.3

Initial Term

   11.1

NDA

   2.3

Non-Obvious Damage

   6.2

Obvious Damage

   6.1

OREXIGEN

   Preamble

OREXIGEN Indemnitees

   9.2

Party

   Preamble

Parties

   Preamble

Price

   5.2

Proceeding

   9.3

Products

   7.1

Proprietary Information

   7.1

Purchase Order

   1.2

Qualification Date

   3.2

Quality Agreement

   8.12

Recalls

   10.2

Receiving Party

   7.1

Regulatory Agency

   2.2

[* * *] Price Change

   5.4

Representatives

   7.3

Rolling Forecast

   3.1

Specifications

   2.1

[* * *] Price Change

   5.4

Supplier Indemnitees

   9.1

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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SCHEDULE A

SPECIFICATIONS

[* * *]

 

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

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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

[* * *]

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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SCHEDULE B

PRICING AND SHIPPING TERMS

Freight Terms: CHEMI shall make all necessary shipping arrangements to
OREXIGEN’s designated facility, CIP (Incoterms 2000) OREXIGEN’s designated
facility, freight prepaid.

Shipping Method: Air Freight

Price:

The initial Price, which shall be subject to adjustment in accordance with
Section 5.3, shall be as follows:

 

[* * *]

  

[* * *]

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

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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APPENDIX A

FORM OF PURCHASE ORDER

Orexigen Therapeutics, Inc.

3344 North Torrey Pines Ct., Sutie 160

San Diego, CA 92130

 

           

PURCHASE

ORDER

              

 

Date

  

 

P.O. No.

                           

 

Vendor

      Ship To              As directed by Orexigen                              
                                                                                
                                                                               
      

 

 

Item

 

  

 

Description

 

            

 

Qty

 

  

 

Rate

 

  

 

Amount

 

                                                                              
                                                                                
                                                                               
                      TOTAL