Exhibit 10.26
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.
NALTREXONE HYDROCHLORIDE SUPPLY
AGREEMENT
This Naltrexone Hydrochloride Supply
Agreement (this “ Agreement ”) is made as of
this day of January 5, 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 CILAG GMBH
INTERNATIONAL (“ CILAG ”), a corporation of
Switzerland located at Landis+Gyr-Strasse 1, 6300 Zug,
Switzerland.
WHEREAS, CILAG is a manufacturer of
Naltrexone Hydrochloride and wishes to manufacture and supply
Naltrexone Hydrochloride to OREXIGEN on the terms described herein;
and
WHEREAS, OREXIGEN desires a supply
of commercial quantities of Naltrexone Hydrochloride on the terms
described herein.
NOW, THEREFORE, in consideration of
the mutual covenants set forth herein, CILAG and OREXIGEN (each, a
“ Party ” and, collectively, the “
Parties ”) agree as follows.
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1.1.
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This Agreement
shall apply to all purchases of Naltrexone Hydrochloride by
OREXIGEN from CILAG during the term of this Agreement.
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1.2.
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This Agreement
does not constitute a purchase order. Purchases under this
Agreement shall be made only with purchase orders issued by
OREXIGEN to CILAG (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 . Purchase Order No. 1153 between the
Parties dated January 2, 2008 shall be deemed an accepted
Purchase Order under and pursuant to the terms of this Agreement.
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.
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1.3.
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All Naltrexone
Hydrochloride sold by CILAG to OREXIGEN will be manufactured by
CILAG in accordance with the terms of this Agreement.
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2.
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M
ANUFACTURING
; S PECIFICATIONS ; Q UALIFICATION OF S ECOND S OURCE
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2.1.
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CILAG shall
manufacture the Naltrexone Hydrochloride supplied 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 CILAG’s drug master file
(“ DMF ”) for Naltrexone Hydrochloride to be
filed with the U.S. Food and Drug Administration (“
FDA ”) pursuant to Section 2.3 (both (a) and
(b), including any modifications approved in accordance with
Section 2.2 collectively, the “ Specifications
”). If CILAG wishes to make any change to the Specifications
or manufacturing process (including, but not limited to, any change
that could affect the purity, potency, identity and/or physical
properties of the Naltrexone 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, including any corresponding
increase or decrease in manufacturing cost, so as to permit
OREXIGEN to understand the reasons for the proposed change and to
evaluate the impact of such change to oral formulations containing
Naltrexone Hydrochloride (the “ Finished Products
”). OREXIGEN may request from time to time that CILAG
implement voluntary changes to the Specifications upon written
request to CILAG. CILAG 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, CILAG 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).
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2.2.
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Without
limiting the generality of the foregoing provisions, CILAG shall
not change the Specifications unless [***], each having
jurisdiction over Naltrexone 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,
CILAG shall not supply to OREXIGEN hereunder, and OREXIGEN shall
have no obligation to accept, any Naltrexone Hydrochloride from
CILAG manufactured in contravention of this
Section 2.2.
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2.3.
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CILAG will take commercially
reasonable steps necessary to enable OREXIGEN to secure from the
relevant Regulatory Agencies approval of CILAG and any applicable
Second-Source Supplier (as defined in Section 2.5) as a source
of supply of Naltrexone Hydrochloride for OREXIGEN’s Finished
Products to be marketed anywhere in the world. Without limiting the
generality of the foregoing, CILAG will supply to OREXIGEN
sufficient quantities of Naltrexone 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 CILAG or
any applicable Second-Source Supplier as its supplier of Naltrexone
Hydrochloride for its initial Finished Product candidate. CILAG
will be responsible for procuring and maintaining all regulatory
filings and any other compliance efforts, including without
limitation,
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***
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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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the DMF, related to Naltrexone
Hydrochloride that are required in order to obtain approval from
the FDA of OREXIGEN’s NDAs (or ANDAs, if applicable)
referencing Naltrexone Hydrochloride and equivalent approvals from
Regulatory Agencies in other jurisdictions, at no additional cost
to OREXIGEN. CILAG shall file the DMF with the FDA and shall
provide 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 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. [***].
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2.4.
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CILAG shall
test, or have tested, each lot of Naltrexone 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 Naltrexone Hydrochloride supplied hereunder to the
Specifications and all Applicable Laws (as defined in
Section 8.1.1). With each shipment of Naltrexone
Hydrochloride, CILAG shall deliver to OREXIGEN certificates of
analysis from CILAG (a) stating that the Naltrexone
Hydrochloride being shipped has been tested and does conform to the
Specifications, (b) setting forth in detail the testing
methodology employed by CILAG 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 CILAG notice, with respect to the manufacture and testing of
Naltrexone Hydrochloride for use as an active pharmaceutical
ingredient in the Finished Products and subsequent sale in such
jurisdictions.
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2.5.
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CILAG shall
have the option, at its sole cost and expense and subject to the
terms and conditions of this Agreement, to qualify one
second-source supplier for Naltrexone Hydrochloride (“
Second-Source Suppler ”). CILAG shall provide at least
[***] ([***]) months prior written notice of its intent to so
qualify a Second-Source Supplier. CILAG shall not implement the use
of such Second-Source Supplier until (i) OREXIGEN has approved
such Second-Source Supplier, which approval shall not be
unreasonably withheld, including the conduct by OREXIGEN of an
audit of the Second-Source Supplier, and (ii) OREXIGEN has
received the requisite approvals from all applicable Regulatory
Agencies to use such Second-Source Supplier.
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3.
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F
ORECASTS
; F IRM C OMMITMENT ; P URCHASE O RDERS
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3.1.
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In order to assist CILAG in
planning the production runs for Naltrexone Hydrochloride,
beginning at least [***] ([***]) year prior to OREXIGEN’s
anticipated Commercial Launch (as defined in Section 3.2),
OREXIGEN shall use its commercially reasonable efforts to provide
to CILAG, prior to the beginning of each calendar quarter, a twelve
(12) month rolling forecast of the quantities of Naltrexone
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 [***] ([***]) months of each
Rolling Forecast shall constitute a binding order on CILAG and
OREXIGEN for the quantities of
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***
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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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Naltrexone Hydrochloride specified
therein (“ Firm Commitment ”), and the following
[***] ([***]) months of the Rolling Forecast shall be non-binding
estimates and shall be used by CILAG for planning purposes only.
CILAG shall be obligated to supply no less than [***] percent
([***]%) of the quantity of Naltrexone Hydrochloride ordered by
OREXIGEN pursuant to any Purchase Order which complies with
Section 3.3. Further, CILAG agrees to use commercially
reasonable efforts to deliver any quantities of Naltrexone
Hydrochloride ordered by OREXIGEN which exceed OREXIGEN’s
Rolling Forecast 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.
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3.2.
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After the
Finished Products have received approval for marketing from a
Regulatory Agency and have been made generally commercially
available (hereinafter “ Commercial Launch ”),
CILAG shall, within [***] ([***]) business days after OREXIGEN has
provided its quarterly forecast, notify OREXIGEN in writing of any
prospective problems CILAG 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 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 CILAG 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.
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3.3.
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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 Naltrexone
Hydrochloride ordered, the total Price (as defined in
Section 5.2) for such quantities of Naltrexone 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
CILAG 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, CILAG shall
acknowledge receipt of OREXIGEN’s Purchase Order and confirm
that the amounts of Naltrexone Hydrochloride ordered in the
Purchase Order will be timely supplied. For the avoidance of doubt,
CILAG shall be obligated to accept any such Purchase Order which
complies with this Section 3.3. Notwithstanding the foregoing,
any failure by CILAG to respond to a Purchase Order within such
[***] ([***]) day period shall be deemed acceptance of such
Purchase Order.
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3.4.
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CILAG agrees to retain at least a
rolling [***] ([***]) month safety stock of Naltrexone
Hydrochloride or intermediates to be used for sale by OREXIGEN
based on the average monthly quantities in the Rolling Forecast.
CILAG will promptly notify OREXIGEN if CILAG’s manufacturing
capacity will be insufficient to fill a Purchase Order submitted by
OREXIGEN, and CILAG agrees that OREXIGEN shall receive [***] of
CILAG based upon OREXIGEN’s Rolling Forecast for Naltrexone
Hydrochloride for the applicable quarter. Such notice will include
the expected duration of the shortage and its impact on
the
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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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supply of Naltrexone Hydrochloride
to OREXIGEN. Such notification shall not operate to relieve CILAG
of its obligations to deliver the ordered amounts of Naltrexone
Hydrochloride or affect OREXIGEN’s right to pursue any
remedies that may be available to it. CILAG will use its best
efforts to mitigate the impact on OREXIGEN of shortages or other
constrained capacity. The obligations of CILAG to maintain the
safety stock specified herein shall commence as of the Commercial
Launch.
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3.5.
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During any
period during this Agreement in which CILAG, for any reason,
including, without limitation, a force majeure as provided in
Section 13.1, fails to deliver the requisite quantities of
Naltrexone Hydrochloride included within any Firm Commitment
Purchase Order, within [***] ([***]) days after the date of
delivery confirmed in writing by CILAG or if CILAG otherwise
anticipates or notifies OREXIGEN that it will be unable to make
delivery of all or a portion of the ordered Naltrexone
Hydrochloride within [***] ([***]) days after the confirmed date of
delivery, then OREXIGEN may refuse such late shipment of Naltrexone
Hydrochloride from CILAG and purchase such quantities under such
Firm Commitment Purchase Order through a substitute third party
supplier. The quantity of Naltrexone Hydrochloride purchased from
the substitute supplier due to CILAG’s failure to supply
shall be treated as if it were purchased from CILAG for purposes of
determining the [***] in the table of Schedule B for subsequent
purchase of Naltrexone Hydrochloride. In the event CILAG regains
its ability to resume supplying hereunder, OREXIGEN’s right
to purchase Naltrexone Hydrochloride from the substitute supplier
shall terminate immediately upon the delivery by CILAG to OREXIGEN
of written notice thereof except in respect of orders already
placed or obligated to be placed by OREXIGEN from the substitute
supplier . Notwithstanding CILAG’s reinstatement, if
CILAG fails to timely meet its continuing manufacturing and supply
obligations to OREXIGEN (consistent with all representations,
warranties and covenants herein) on more than [***] occasions
during [***], then in addition to any termination rights hereunder,
the Exclusivity Obligation (as defined in Section 5.1) shall
be of no further force and effect with respect to OREXIGEN for
[***] and [***], provided, however, CILAG shall still be obligated
to perform all of its obligations under this Agreement.
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4.1.
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Each Purchase
Order shall specify the quantity of Naltrexone Hydrochloride
ordered and the required delivery date and destination, consistent
with the terms of this Agreement. Deliveries must be made on normal
business days of the designated facility unless otherwise
coordinated.
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4.2.
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Subject to any
written agreement between OREXIGEN and CILAG to the contrary, CILAG
shall make all necessary shipping arrangements to OREXIGEN’s
designated facility. Freight terms shall be as set forth in
Schedule C . Title of the Naltrexone Hydrochloride
shall pass from CILAG to OREXIGEN upon receipt by OREXIGEN or its
designated agents of such product at the location specified in the
Purchase Order.
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***
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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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4.3.
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CILAG shall
deliver the complete order amounts on the delivery date specified
in the Purchase Order. CILAG shall be responsible for coordinating
the import/export of the Naltrexone Hydrochloride to the United
States and to OREXIGEN’s designated manufacturing facilities
in a timely manner and in compliance with the Specifications and
all Applicable Laws. CILAG shall notify OREXIGEN of the expected
delivery date of the order to enable receipt to be
coordinated.
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4.4.
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Subject to
clearance by customs and, if required, the FDA or other Regulatory
Agency, the Naltrexone Hydrochloride shall be delivered to
OREXIGEN’s designated facility in CILAG’s normal
packaging and documentation for Naltrexone Hydrochloride,
including, without limitation, any such procedures as reflected in
CILAG’s DMF, provided that such packaging and documentation
shall meet the customs and regulatory requirements within the
United States and/or Canada, as applicable, to the location of
OREXIGEN’s designated facility for delivery. Each shipment
shall include certificates of analysis, 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.
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5.
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E
XCLUSIVITY
; P RICE ; P AYMENT
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5.1.
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From a period beginning on the
first December 31 st following marketing approval by
the FDA for a Finished Product (the “ Qualification
Date ”) and continuing though the term of this Agreement,
OREXIGEN agrees to purchase from CILAG [***] percent ([***]%) of
its requirements for Naltrexone Hydrochloride intended for
commercial sale in Finished Products (the “ Exclusivity
Obligation ”), provided that the Exclusivity Obligation
shall not be binding on OREXIGEN (a) in the event of breach by
CILAG of any of the terms set forth herein which breach is not
cured within the period set forth in Section 11.2 or
(b) under the circumstances set forth in Section 3.5.
[***].
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5.2.
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The price for
the Naltrexone Hydrochloride to be purchased by OREXIGEN hereunder
is set forth in Schedule B , as adjusted in accordance
with this Section 5 (the “ Price
”).
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5.3.
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The Price shall remain fixed for
the first [***] ([***]) months of the Agreement, and thereafter
shall be adjusted in accordance with this Section 5.3 on [***]
to take effect for orders to be delivered after such applicable
[***] date. The Price shall be adjusted based on any increase or
decrease in the [***] over the previous [***] (the “[***]
Price Adjustment ”), provided that any such increase
or decrease is supported by documentation reasonably satisfactory
to the other Party evidencing such [***] Price Adjustment; and
provided further that the [***] Price Adjustment shall not exceed
[***] percent ([***]%) of the average price per kilogram paid by
OREXIGEN for purchases made in the previous [***]. The Price shall
also be adjusted [***] based on the percent increase or decrease in
the [***] measured over the previous [***] (the “[***]
Adjustment ”), provided that any such increase or
decrease is supported by documentation reasonably satisfactory to
the other Party evidencing such [***] Adjustment. CILAG 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
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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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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,
CILAG 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 CILAG that
the [***] changes are necessary [***], then OREXIGEN shall, within
[***] ([***]) days of receipt of such notice from CILAG, notify
CILAG in writing of OREXIGEN’s disagreement and the rationale
for such disagreement. The 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.
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5.4.
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If at any time
during the term, [***].
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5.5.
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If at any time
on or after the [***].
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5.6.
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CILAG agrees to
keep full, clear and accurate books and records with respect to
costs of commercial manufacture of Naltrexone Hydrochloride for a
minimum period of [***] ([***]) years after the calendar year in
which they are prepared, or for such longer period as may be
required by Applicable Law. OREXIGEN shall have the right to have a
third party independent external auditor conduct an audit of
CILAG’s books and records for the purpose of verifying any
Price adjustments made pursuant to this Section 5.3, 5.4 or
5.5 If so requested by OREXIGEN, such independent external auditor
shall provide written confirmation of the accuracy of any Price
adjustments in Sections 5.3, 5.4 or 5.5 prior to the implementation
of such Price adjustments. If the independent external auditor is
unable to confirm such Price adjustments, the Price [***]. The
final report of the independent external auditor shall be shared
with both of the Parties. Any amounts that are determined to be due
and owing by one Party to the other Party following such audit
shall be paid within [***] ([***]) days thereafter. OREXIGEN shall
bear the cost of such audit The Parties shall cooperate with one
another in good faith to resolve any disputes concerning the
auditor’s conclusions in accordance with
Section 13.3.
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5.7.
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CILAG 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.
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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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6.
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I
NSPECTION
OF S HIPMENTS
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6.1.
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OREXIGEN shall
visually inspect or have visually inspected the Naltrexone
Hydrochloride delivered hereunder for obvious damage, failure to
meet Specifications and/or shortage (collectively, “
Obvious Damage ”) after receipt thereof and shall
provide CILAG with written notice of any such Obvious Damage within
[***] ([***]) days after receipt. OREXIGEN shall be deemed to have
accepted any shipment of Naltrexone Hydrochloride, but only with
respect to Obvious Damage, unless CILAG 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 Naltrexone Hydrochloride supplied to OREXIGEN.
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6.2.
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At any time
within [***] ([***]) months after receipt of any lot of Naltrexone
Hydrochloride but promptly after discovery, OREXIGEN may provide
CILAG with written notice of any non-obvious damage, including
adulteration of the Naltrexone 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 .” OREXIGEN may reject any portion of
any shipment of Naltrexone Hydrochloride which contains any Damage
by providing written notice to CILAG of its rejection. OREXIGEN
agrees to provide CILAG’s Quality Control Department with
documentation of Damage to confirm the existence thereof in
connection with any notice of rejection
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6.3.
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If CILAG 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
scientific investigation. If after such repeated analyses CILAG and
OREXIGEN continue to disagree, they 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 CILAG
and OREXIGEN. The costs associated with such submission shall be
borne by the Party against which the lab decided.
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6.4.
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Provided OREXIGEN provides notice
of the damage claimed within [***] ([***]) days of receipt of the
allegedly Damaged Naltrexone Hydrochloride, in the case of Obvious
Damage, and within [***] ([***]) months of receipt of the allegedly
Damaged Naltrexone Hydrochloride in the case of Non-Obvious Damage,
whether or not CILAG accepts OREXIGEN’s basis for rejection,
CILAG shall promptly, on receipt of a notice of rejection and its
prompt verification of the Damage 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 Naltrexone
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
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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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such Naltrexone Hydrochloride until
such time as conforming replacement Naltrexone Hydrochloride has
been received. CILAG will use expedited means of transport, if so
requested by OREXIGEN at OREXIGEN’s expense unless such
Naltrexone Hydrochloride being replaced is determined to have been
Damaged.
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6.5.
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Notwithstanding
any other provisions of this Agreement, OREXIGEN agrees, if so
requested by CILAG, to return to CILAG, at CILAG’s expense,
any Naltrexone Hydrochloride that is deemed to be Damaged pursuant
to this Section 6, or otherwise to dispose of such Naltrexone
Hydrochloride as CILAG may request.
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7.1.
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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 .”
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7.2.
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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.
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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) CILAG may disclose the existence (but not the terms of)
this Agreement to bona fide potential investors and financial
advisors.
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***
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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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7.4.
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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.
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7.5.
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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 will exercise its commercially
reasonable efforts to obtain reliable assurance that confidential
treatment will be accorded to such Proprietary
Information.
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7.6.
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Notwithstanding
any of the foregoing, the term “Proprietary
Information” and the obligation of confidentiality
associated
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