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NALTREXONE HYDROCHLORIDE SUPPLY AGREEMENT

Requirements Supplier Agreement

NALTREXONE HYDROCHLORIDE SUPPLY AGREEMENT | Document Parties: OREXIGEN THERAPEUTICS, INC. You are currently viewing:
This Requirements Supplier Agreement involves

OREXIGEN THERAPEUTICS, INC.

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Title: NALTREXONE HYDROCHLORIDE SUPPLY AGREEMENT
Governing Law: California     Date: 3/13/2009
Industry: Biotechnology and Drugs     Law Firm: Latham Watkins     Sector: Healthcare

NALTREXONE HYDROCHLORIDE SUPPLY AGREEMENT, Parties: orexigen therapeutics  inc.
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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.

 

1.

S COPE OF A GREEMENT

 

1.1.

This Agreement shall apply to all purchases of Naltrexone Hydrochloride by OREXIGEN from CILAG during the term 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 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.

 

1.3.

All Naltrexone Hydrochloride sold by CILAG to OREXIGEN will be manufactured by CILAG in accordance with the terms of this Agreement.


2.

M ANUFACTURING ; S PECIFICATIONS ; Q UALIFICATION OF S ECOND S OURCE

 

2.1.

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).

 

2.2.

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.

 

2.3.

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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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. [***].

 

2.4.

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.

 

2.5.

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.

 

3.

F ORECASTS ; F IRM C OMMITMENT ; P URCHASE O RDERS

 

3.1.

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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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.

 

3.2.

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.

 

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 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.

 

3.4.

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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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.

 

3.5.

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.

 

4.

D ELIVERY

 

4.1.

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.

 

4.2.

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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4.3.

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.

 

4.4.

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.

 

5.

E XCLUSIVITY ; P RICE ; P AYMENT

 

5.1.

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. [***].

 

5.2.

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 ”).

 

5.3.

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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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.

 

5.4.

If at any time during the term, [***].

 

5.5.

If at any time on or after the [***].

 

    

[***].

 

5.6.

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.

 

5.7.

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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6.

I NSPECTION OF S HIPMENTS

 

6.1.

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.

 

6.2.

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

 

6.3.

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.

 

6.4.

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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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.

 

6.5.

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.

 

7.

C ONFIDENTIALITY

 

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.

 

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) CILAG may disclose the existence (but not the terms of) this Agreement to bona fide potential investors and financial advisors.

 

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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.


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 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


 
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