EX-10.26 3 d311974dex1026.htm SUPPLY AGREEMENT Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a request for confidentiality and filed separately with the Securities and Exchange Commission. Execution Copy SUPPLY...
EXHIBIT 10.26
Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidentiality and filed separately with the Securities and Exchange Commission.
Execution Copy
SUPPLY AGREEMENT, dated as of November 1, 2010 (the “Agreement”), by and between Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc., a Pennsylvania corporation (“Seller”), and Xxxxxx Laboratories, Inc., a Nevada corporation (“Purchaser”).
SECTION 1
As used throughout this Agreement and any exhibits, schedules or attachments hereto, each of the following terms shall have the respective meaning set forth below:
1.1 “Additional Amount” shall have the meaning set forth in Section 2.3.3.
1.2 “Affiliate” of a party shall mean any entity that, directly or indirectly, controls, is controlled by, or is under common control with such entity (except as provided in Section 1.42).
1.3 “Agreement” shall have the meaning set forth in the preamble.
1.4 “ANDA” shall mean an Abbreviated New Drug Application filed with the FDA.
1.5 “Appeal Arbitrator” shall have the meaning set forth in Section 17.2.7.
1.6 “Bankruptcy Code” shall have the meaning set forth in Section 7.4.
1.7 “Bankruptcy Laws” shall have the meaning set forth in Section 7.4.
1.8 “Calendar Quarter” shall mean a calendar quarter based on Seller’s universal calendar for that year and shall be updated by Seller for each Calendar Year of the term of this Agreement consistent with Seller’s universal calendar used for Seller’s internal business purposes; provided, however, that the first Calendar Quarter for the first Calendar Year shall extend from the date of this Agreement to the end of the then current Calendar Quarter and the last Calendar Quarter shall extend from the first day of such Calendar Quarter until the effective date of the termination or expiration of the Agreement. Upon Purchaser’s written request, Seller shall provide Purchaser with a copy of Seller’s universal calendar from the Start Date through December 31, 2014.
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1.9 “Calendar Year” shall mean a calendar year during the term of this Agreement based on Seller’s universal calendar for that year. The last Calendar Year of the term of this Agreement shall begin on the first day of Seller’s universal calendar for the year during which termination or expiration of the Agreement will occur, and the last day of such Calendar Year shall be the effective date of such termination or expiration.
1.10 “Change in Control” shall mean: (i) the liquidation or dissolution of Purchaser’s publicly listed parent corporation, Xxxxxx Pharmaceuticals, Inc., a Nevada Corporation (“WPI”) (or of Purchaser) or the sale or other transfer by WPI (or by Purchaser) (excluding transfers to Affiliates) of all or substantially all of its assets; (ii) the occurrence of a tender offer, stock purchase, other stock acquisition, merger, consolidation, recapitalization, reverse split, sale or transfer of assets or other transaction, as a result of which any person, entity or group other than an Affiliate of WPI (a) becomes the beneficial owner, directly or indirectly, of securities of WPI representing more than 50% of the ordinary shares of WPI (or of Purchaser) or representing more than 50% of the combined voting power with respect to the election of directors (or members of any other governing body) of WPI’s (or of Purchaser’s) then outstanding securities, (b) obtains the ability, through an event or series of events, to appoint a majority of the Board of Directors (or other governing body) of WPI (or of Purchaser), or (c) obtains the ability to direct the operations or management of WPI (or of Purchaser) or any successor to WPI’s (or Purchaser’s) business.
1.11 “COGS” shall have the meaning set forth in Section 3.2.
1.13 “CPR” shall have the meaning set forth in Section 17.2.1.
1.14 “DEA” shall mean the United States Drug Enforcement Administration, and any successor or replacement agency.
1.15 “Equivalent Product” shall mean any pharmaceutical product which is manufactured by a party other than Seller or its Affiliate pursuant to an ANDA which was approved by the FDA, which ANDA was approved as bioequivalent to the NDA Product.
1.16 “FDA” shall mean the U.S. Food and Drug Administration, and any successor or replacement agency.
1.17 “FTC” shall mean the U.S. Federal Trade Commission Bureau of Competition.
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1.18 “Force Majeure Event” shall have the meaning given in Section 11.1.
1.19 “GAAP” shall have the meaning set forth in Section 1.25.
1.20 “Indemnity Claim” shall have the meaning set forth in Section 16.3.
1.21 “Initial Order” shall have the meaning set forth in Section 2.3.1.
1.22 “Loss Leader” shall mean discounting the Product to a customer as an inducement to purchase additional or other products or services from Purchaser or its Affiliates or increase the level of business such customer would have conducted with the Purchaser or its Affiliates.
1.23 “Material Change” shall have the meaning set forth in Section 5.2.1.
1.24 “Minimum Amount” shall have the meaning given on Exhibit B.
1.25 “Net Sales” shall mean, with respect to any Product, the gross amounts invoiced from the sale of such Product by Purchaser, its Affiliates and assignees to independent Third Parties in an arms-length transaction, in each case after subtracting the following to the extent specifically and solely allocated to such Product and actually taken, paid, accrued, allowed, included or allocated based on good faith estimates in the gross sales prices with respect to such sales (and consistently applied as set forth below): (i) all normal and customary discounts of any type or nature (such as retroactive price reductions, cash discounts, volume discounts, chargebacks, allowances, rebates, returns and credits, excluding commissions for commercialization); (ii) compulsory payments and cash rebates related to the sales of such Product paid to a government authority (or agent thereof) pursuant to governmental regulations by reason of any national or local health insurance program or similar program (such as Medicaid and Supplemental State Program rebates, Medicare Part D “Donut Hole” Coverage Gap rebates and “Industry Fees” for Brand Drugs as required by the Patient Protection and Affordable Care Act as amended by the Health Care Education Affordability Reconciliation Act), to the extent allowed and taken; and (iii) one percent (1%) of the gross Product revenues on a monthly basis to account for freight, shipping, insurance costs, excise taxes, use taxes, sales taxes and custom duties, and/or government charges imposed on the sales of such Product. Net Sales shall be determined on an accrual basis in accordance with generally accepted accounting principles (“GAAP”) in the Territory (except for those items identified in clause (ii) and (iii) above that are classified as operating expenses for GAAP purposes), applied on a basis consistent with Purchaser’s annual audited financial statements, with monthly Net Sales calculations in any year subject to adjustment pending completion of Purchaser’s annual audit for that year. All such discounts, allowances, credits, rebates, and other deductions shall be fairly and equitably allocated to the Product and other
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
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products of Purchaser and its Affiliates such that such Product does not bear a disproportionate portion of such deductions. For the avoidance of doubt, inclusion of the Products in Purchaser’s portfolio rebate program or substantially similar customer rebate programs shall be permitted, provided that such program does not discount the Product at a rate or percentage that is greater than the rate or percentage of discount applied to other products in the same program.
1.26 “NDA” shall mean New Drug Application No. 021121, filed with the FDA, as amended or supplemented.
1.27 “NDA Product” shall mean the products approved and marketed in the United States under NDA No. 021121, as amended or supplemented.
1.28 “Net Selling Price” shall have the meaning given in Section 3.1.
1.29 “NSP Report” shall have the meaning set forth in Section 3.1.
1.30 “Overdue Interest Amount” shall mean the Prime Rate of interest quoted as such in The Wall Street Journal on the first business day of the month during which an amount becomes overdue under this Agreement, plus [**]%, calculated on an annual basis.
1.31 “Pharmacovigilence Agreement” has the meaning set forth in Section 10.1.
1.32 “Product” or “Products”, as applicable, shall mean each of the products listed on Exhibit A to this Agreement, and any other products the parties agree to include herein.
1.33 “Purchase Price” has the meaning set forth in Section 3.1.
1.34 “Purchaser Trademarks” shall have the meaning set forth in Section 5.4.
1.35 “Quality Agreement” shall have the meaning set forth in Section 5.3.
1.36 “Remaining Amount” shall have the meaning given in Section 3.5.
1.37 “Specifications” shall mean the specifications for the design, composition, manufacture, packaging, and/or quality control of the Products, as the same may hereafter be modified by mutual agreement of the parties in writing.
1.38 “Start Date” shall mean the earlier of (i) May 1, 2011, or (ii) the date on which a Third Party commercially launches a product in the Territory that is approved by FDA under an ANDA for which the NDA Product is the reference-listed drug.
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1.39 “Territory” shall mean the United States of America, including its territories and possessions (including, but not limited to, the Commonwealth of Puerto Rico).
1.40 “Third Party” or “Third Parties” shall mean any person or entity other than Seller, Purchaser, or their respective Affiliates.
1.41 “Total Cap” shall have the meaning set forth in Section 15.3(B).
1.42 “Wholesaler Affiliate” means a subsidiary or affiliate of Purchaser whose primary business is wholesale distribution of pharmaceutical products. A Wholesaler Affiliate shall not be deemed to be an Affiliate of Purchaser.
SECTION 2
2.1.1 During the term of this Agreement, Seller shall exclusively supply Purchaser with those quantities of Products as are ordered by Purchaser pursuant to this Agreement, and (subject to the provisions of Section 4.5) Purchaser shall exclusively purchase from Seller 100% of Purchaser’s requirements for the Products; provided, however, Seller shall not be obligated to supply Purchaser with any Products in the event Purchaser has an inventory level of such Products in excess of [**] ([**]) weeks of the current market demand as described in Section 4.2.
2.1.2 During the term of this Agreement (and subject to the provisions of Section 4.5), Purchaser shall exclusively purchase from Seller the Products solely for distribution, marketing and sale in the Territory, and shall not purchase, market, distribute or sell any Products or any Equivalent Product in the Territory which are not provided by Seller under this Agreement. As set forth in the last sentence of the definition of “Net Sales”, Purchaser may include Products in Purchaser’s portfolio rebate program or substantially similar customer rebate programs; provided, however, Purchaser shall not use Products as a Loss Leader in such program or in any other arrangement.
2.1.3 Purchaser acknowledges that Seller manufactures identical or similar products for sale by it or its Affiliates in the Territory and to Third Parties outside of the Territory, and Seller shall not be restricted from such activities by virtue of this Agreement. Notwithstanding the foregoing, Seller agrees that it shall not market or sell any generic version of a Product through its own sales organization or distribution channels (or those of any of its Affiliates) or through any Third Party in the Territory during the term of this Agreement.
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2.1.4 Nothing in this Agreement shall prohibit Purchaser from continuing or undertaking its own development of any Equivalent Product, seeking regulatory approval of any such Equivalent Product, or undertaking manufacturing development and qualification, and limited manufacture (including third party manufacturing) of stability batches and validation batches of Equivalent Products, in each case solely for purposes of seeking regulatory approval for such Equivalent Product; provided, however, that subject to the provisions of Section 4.5 and during the term of this Agreement with respect to the applicable Product, the parties acknowledge that Purchaser shall not be permitted to sell in the Territory any Equivalent Product which it so manufactures during the term of this Agreement. Notwithstanding anything in this Agreement to the contrary, nothing in this Agreement shall be interpreted to preclude Purchaser from selling any Equivalent Products outside of the Territory or manufacturing in or outside of the Territory such Equivalent Products solely for purposes of sales outside of the Territory so long as (i) such Equivalent Products do not use any confidential or proprietary information of Seller and (ii) such Equivalent Products are not manufactured using the same or substantially similar trade dress or trade names as used for the Products in the Territory, unless required by law in the jurisdiction outside of the Territory in which Purchaser sells such Equivalent Products.
2.2.1 Purchaser shall only sell the Products in the Territory and shall not, directly or indirectly, offer such Products to any Third Party which Purchaser knows is going to market, distribute or sell such Products, directly or indirectly, outside the Territory.
2.2.2 Purchaser shall immediately cease sale or distribution of any Product to any Third Party who Purchaser knows is marketing, selling or distributing any of the Products, directly or indirectly, outside of the Territory. Purchaser shall also reasonably cooperate with Seller in investigating and tracing any sales of the Products outside of the Territory. Any failure by Purchaser to cease shipments of Products to such a Third Party shall be deemed a material breach of this Agreement.
2.3.1 Seller shall be obligated to commence supply of each Product to Purchaser as set forth on an initial order (“Initial Order”) from Purchaser. The quantities in such purchase order shall be in the amounts set forth on Exhibit C to this Agreement.
2.3.2 Seller shall deliver to Purchaser the quantities of Products subject to the Initial Order no later than April 15, 2011; provided that, in the event the Start Date is prior to April 15, 2011, Seller shall deliver to Purchaser the quantities of Products subject to the Initial Order on or prior to the Start Date or as soon thereafter as Seller is able to do so taking into account its product availability and production capacity at such time. In the event the Start Date occurs prior to April 15, 2011, Seller shall be permitted to supply rolling shipments of Products to Purchaser in order to fulfill Purchaser’s Initial Order in the manner set forth in this paragraph 2.3.2.
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
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2.3.3 It is the intent of the parties that each Product supplied to Purchaser under this Agreement shall be delivered to retail pharmacies on or after the Start Date. Consequently, if Product supplied to Purchaser under this Agreement is delivered to retail pharmacies earlier than the Start Date, then Purchaser shall pay to Seller, as liquidated damages (the “Additional Amount”), an amount equal to (A) (i) the number of units of Product shipped or distributed by Purchaser to any retail pharmacies prior to the Start Date times (ii) Seller’s branded published direct price (i.e., list price) for Seller’s branded version of such Product, less (B) the amount paid or payable by Purchaser to Seller for such Products under Section 3 below. The Additional Amount shall be Seller’s sole remedy (whether arising in contract, tort or otherwise) for the premature sale of Products by Purchaser.
SECTION 3
3.1 Transfer Prices. The purchase price (“Purchase Price”) for each Product purchased from Seller shall be a percentage of Purchaser’s Net Selling Price for such Product, as calculated on a monthly basis in the percentages set forth on Exhibit B. The Net Selling Price (“Net Selling Price”) for a Product shall be calculated by dividing the Net Sales for such Product (based upon the Products sold by Purchaser to customers during any particular calendar month), by the number of units of such Product so sold by Purchaser. The Purchaser shall within ten business (10) days after the end of each calendar month, provide to Seller actual, definitive Net Selling Price information for such month (“NSP Report”). The parties will reasonably cooperate with each other and share such information as is reasonably necessary to reconcile any differences between the last day of the month in a Calendar Quarter with the last day of the corresponding Gregorian calendar month. Such definitive Net Selling Price information shall contain reasonable details as to the calculation of the Net Selling Price. For the purpose of calculating Net Selling Price, Net Sales of Products sold by Purchaser or its Affiliates to a Wholesaler Affiliate shall be deemed to have been made at the higher of (i) the actual transfer price from Purchaser or its Affiliates to the Wholesaler Affiliate, or (ii) the average Net Sales price of such Product based on sales to Third Parties other than Wholesaler Affiliates during the month in which the sale was made.
3.2 Minimum Amount. The parties acknowledge that the Minimum Amounts set forth on Exhibit B are equal to the cost of the Products (“COGS”), as calculated by Seller, plus [**] percent ([**]%) of COGS. Starting in December 2011, Seller and Purchaser agree that the Minimum Amounts set forth on Exhibit B shall be updated on an annual basis based on COGS, as calculated by Seller, provided to Purchaser by Seller. Seller agrees that any annual increase of COGS of each Product will not exceed [**] percent ([**]%) of COGS of the immediately preceding annual COGS of such Product, as applicable. Starting in December 2011, Seller shall provide COGS for each Product thirty (30) days prior to the end of the Calendar Year. Purchaser shall have the right to review and audit
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
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Seller’s calculation of COGS under the same audit guidelines which are applicable to Seller contained in Section 3.7. The Minimum Amounts for each Product shall be effective January 1 of the year following the date Seller provides Purchaser with updated COGS. In the event the Net Selling Price is below the Minimum Amount for the Products, as applicable, for a period of [**] ([**]) consecutive months, each party shall have the right to terminate this Agreement prior to the expiration of its term by giving [**] ([**]) months prior written notice of its intent to terminate; provided, however, prior to either party exercising such termination right, the parties shall attempt in good faith to discuss the Minimum Amount and negotiate a resolution for a period of thirty (30) days. In the event either party issues a notice of termination pursuant to this Section 3.2, Purchaser shall use commercially reasonable efforts to manufacture commercial quantities of Equivalent Product. If Purchaser is able to manufacture such commercial quantities of Equivalent Product prior to the end of the [**] month notice period, the Agreement termination date shall be accelerated to the date Purchaser is ready to commercially launch its Equivalent Product; provided, however, that Purchaser shall provide Seller with at least thirty (30) days prior written notice of such date that Purchaser is ready to commercially launch its Equivalent Product and such date shall be at least [**]([**]) months after the termination notice was given unless both parties agree otherwise.
3.3 Samples. No samples, promotional products or similar free goods shall be provided by Seller under this Agreement, unless otherwise agreed to by the parties.
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payment shall incur an interest charge at the rate of the Overdue Interest Amount on such overdue amounts, excluding any amounts that are subject to a bona fide dispute between the parties. In addition, Seller may withhold shipment of Product to Purchaser if Purchaser has failed to make any payment required under this Agreement (except for any amounts that are subject to a bona fide dispute) for a period of sixty (60) days or longer after the due date for such payment. All payments shall be made through electronic transfer of funds or other wire transfers.
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
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SECTION 4
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to end or the date Seller expects to receive Products from its supplier. In the event of such shortage, Seller shall allocate its available production capacity or available raw material available for the production of the NDA Product to be sold in the Territory to the production of Products in accordance with Exhibit D.
SECTION 5
SPECIFICATIONS
5.1.1 Seller shall provide Purchaser with the Specifications for each of the Products no later than December 31, 2010. The Specifications for each Product shall not be changed except as permitted under this Agreement.
5.1.2 The parties agree to cooperate in good faith to adopt new packaging for each Product. Purchaser shall provide its packaging specifications for the Products to Seller no later than December 31, 2010.
5.2.1 From time to time during the term of this Agreement, either party may submit to the other written proposals for the adoption, implementation or development of any change, improvement or modification to the Product. If such change is proposed by Seller, such change may be implemented by Seller after consultation with Purchaser (but without requiring Purchaser’s consent) so long as such change does not negatively impact the safety or efficacy of the Products, increase Purchaser’s liability with respect to the Products, adversely impact the commercial value to Purchaser of the Products, or result in a change to the tradename or basic packaging for the Product (any such change hereinafter referred
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to as a “Material Change”). If such change is a Material Change, Seller shall not be permitted to make such change without the prior consent of Purchaser, such consent not to be unreasonably withheld or delayed, and subject to the provisions of Sections 5.2.2 and 5.2.3 below. The Specifications shall be modified to reflect any such changes. In the event of any change, Seller shall establish an appropriate qualification protocol, and Purchaser and Seller shall determine an appropriate inventory level for the pre-change Product in order to cover on-going requirements during the qualification process. The foregoing shall not preclude Seller from implementing process changes or other manufacturing related changes so long as such changes do not (i) require any filing or notifications to the FDA or DEA and (ii) materially alter the Specifications.
5.2.2 In the event that Seller is required to change the Product Specifications pursuant to applicable law, rule, or regulation or in response to the order of a governmental authority or regulatory body, Seller shall promptly advise Purchaser in writing of any such change, as well as any scheduling adjustments which may result from such change. Seller shall bear a percentage of all costs related to any such change required by the regulatory or governmental authority, such percentage calculated by multiplying such costs by the percentages set forth in Exhibit B for the corresponding period requiring such change, and Purchaser shall bear the remaining percentage of such costs; provided, however, that if such change relates to Seller’s manufacturing facility generally or to equipment which is not specifically dedicated to the Products, then Seller shall be responsible for such costs (subject to a reasonable allocation for that portion which is attributable to the Products). Upon request, Seller shall provide reasonable documentation of its costs related to such change and permit Purchaser to review and audit such costs under the same audit guidelines which are applicable to Seller contained in Section 3.7.
5.2.3 In addition to the changes under Section 5.2.2, Purchaser shall also have the right to request that a change be made to the Specifications at its expense (including the expense of any materials rendered obsolete as a result of such change) and upon prior written notice to Seller. Seller shall not be required to make any such change if (i) it results in the need for any capital investment by Seller, (ii) it results in any cost increases (including manpower allocations or resources) to Seller, (iii) it requires any changes to the regulatory filings or status for the Product (other than items reportable in the NDA annual report required to be filed with FDA each year) or (iv) it is commercially impracticable for Seller to implement (in its reasonable judgment). For any such change, Purchaser shall provide camera ready artwork (in digital format whenever reasonably available to Purchaser) consistent with the Specifications if necessary to facilitate any changes to the Specifications.
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5.5 Certificate of Analysis, Certificate of Compliance. Each shipment of Products to Purchaser shall be accompanied by a certificate of analysis prepared by an authorized representative of Seller confirming that the Products in the shipment have been tested in accordance with the NDA and meet the Specifications and a certificate of compliance prepared by an authorized representative of Seller confirming that the Products have been manufactured in accordance with this Agreement and the NDA. Any deviations and investigations related to such Products shall be documented by Seller in accordance with the NDA and the Quality Agreement.
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SECTION 6
SECTION 7
7.1 Intentionally Omitted.
7.2 Intentionally Omitted.
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SECTION 8
SECTION 9
DEFECTIVE PRODUCT/INSPECTIONS/TESTING
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be deemed to be in compliance with this Agreement. If Purchaser notifies Seller within such thirty (30) day period of any defective Products, then Seller shall have a reasonable opportunity, not to exceed thirty (30) days from receipt of notification, to inspect such defective Products and provide Purchaser with detailed written instructions to return or dispose of such defective Products. If Seller fails to instruct Purchaser as to the disposition of such defective Products, Purchaser may dispose of such defective Products as it sees fit.
SECTION 10
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consistent with good commercial standards in the pharmaceutical industry. Purchaser shall notify Seller of receipt of any report(s) of adverse events or product complaints pursuant to a Pharmacovigilance Agreement. To the extent that any inconsistencies exist between the Pharmacovigilance Agreement and this Agreement, the stipulations and provisions in this Agreement shall prevail. Seller shall have the right to audit Purchaser’s systems with respect to handling adverse event reporting in connection with the Products, any such audit to be done during normal business hours on reasonable notice, and in a fashion to avoid unnecessary disruption to normal business operations. Any complaint or adverse event received by one party that relates to product manufacture or packaging must be reported to the other party within 3 business days. The Pharmacovigilence Agreement shall set forth additional details with respect to the handling of adverse event reporting.
In order to ensure compliance with safety reporting requirements in the respective Territories the parties shall agree on a process and procedure for sharing adverse event information which shall be documented in a Pharmacovigilance Agreement (the “Pharmacovigilence Agreement”). Within thirty (30) days from the effective date of this Agreement each party shall assign a safety representative to begin discussions to ensure a Pharmacovigilence Agreement is executed no later than April 1, 2011. Pending execution of such agreement, the parties shall, as required, within thirty (30) days implement an interim procedure for exchange of any and all information concerning adverse events related to use of the Product regardless of source to ensure each party’s compliance with legal requirements in its respective territories.
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may be needed to confirm the steps taken to rectify such issue. In no event shall an audit of a particular facility exceed two (2) days in duration or involve more than three (3) representatives of Purchaser unless mutually agreed in writing by the parties. Purchaser warrants that all inspections and audits hereunder shall be carried out in a manner that does not unreasonably interfere with Seller’s normal and ordinary conduct of business and that insures the continued confidentiality of Seller’s other business and technical information. Any such representatives shall be reasonably qualified in terms of auditing skill to conduct audits, shall execute a written agreement to maintain in confidence all information obtained during the course of any such audit except for disclosure to Purchaser, and shall comply with Seller’s normal company policies and with security and safety regulations.
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clarification, the parties acknowledge that the foregoing complaint handling procedures shall only apply to complaints which implicate the manufacturing, packaging, testing or storage of a Product.
10.9.1 In the event Seller’s manufacturing, packaging, testing or storage facility producing Products hereunder is inspected by representatives of any federal agency in connection with Seller’s manufacture of a Product, Seller shall notify Purchaser promptly upon learning of such inspection, and shall supply Purchaser with redacted copies of any correspondence or portions of correspondence which relate to such Product. Purchaser may send representatives to such manufacturing, packaging, testing or storage facility and may participate in any portion of such inspection relating to such Product (and shall do so upon the request of Seller). In the event Seller receives any regulatory letter or comments from any federal agency in connection with its manufacture of the Product requiring a response or action by Seller, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a “Warning Letter,” Purchaser promptly will provide Seller with any data or information required by Seller in preparing any response relating to Seller’s manufacture of the Product, and will cooperate fully with Seller in preparing such response.
10.9.2 In the event Purchaser is inspected or receives a regulatory letter or comments from any federal agency in connection to the distribution of the Products, Purchaser shall notify Seller promptly upon learning of such inspection or receiving such documentation. Seller may participate in that portion of such inspection relating to such Product (and shall be required to participate if requested by Purchaser). If Seller or Purchaser requests Seller to participate as described above, Seller and Purchaser shall mutually agree on the response with respect to such Product and Purchaser shall be responsible for submitting any such responses to the regulatory authorities. Purchaser will provide Seller with all data or information reasonably required by Seller in preparing for any such inspection or any response relating to the Products.
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SECTION 12
12.1 Each party agrees to procure and maintain in full force and effect during the term of this Agreement, at its sole cost and expense (i) Statutory Worker’s Compensation Insurance and Employer’s Liability Insurance and (ii) Products Liability and General Liability Insurance with a limit of not less than $[**] per occurrence and $[**] in the aggregate annually. Upon written request, each party shall provide to the other party copies of a certificate of insurance of such insurance coverage. Either party may substitute a program of self-insurance for all or part of the third party insurance required hereunder.
SECTION 13
13.1 As used herein, “Confidential Information” shall include all confidential or proprietary information given to one party by the other party, or otherwise acquired by such party in its performance of this Agreement, relating to such other party or any of its
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Affiliates, including information regarding any of the products of such other party or any of its Affiliates, information regarding its advertising, distribution, marketing or strategic plans or information regarding its costs, productivity or technological advances. Neither party shall use or disclose to Third Parties any Confidential Information of the other (except to comply with its obligations under this Agreement) and each party shall insure that its and its Affiliates’ employees, officers, representatives and agents shall not use or disclose to Third Parties any Confidential Information and upon the termination of this Agreement shall return to the other or destroy all Confidential Information in written form. Confidential Information shall not include information that (i) was already known to receiving party at the time of its receipt thereof or is independently developed by receiving party, as evidenced by its written records, (ii) is disclosed to receiving party after its receipt thereof by a third party who, receiving party knows, has a right to make such disclosure without violating any obligation of confidentiality, (iii) is or becomes part of the public domain through no fault of receiving party or (iv) is independently developed by a party. Except as provided herein, the terms of this Agreement (including, without limitation, the exhibits hereto) shall be maintained in confidence by the parties hereto. The obligations of confidentiality set out above shall survive termination or expiration of this Agreement for a period of three (3) years.
SECTION 14
14.1 The parties hereto covenant and agree that, except as provided for herein below, each will not from and after the date hereof make, issue or release any public announcement, press release, statement or acknowledgment of the existence of, or reveal publicly the terms, conditions and status of, the transactions contemplated herein, without the prior written consent of the other party as to the content and time of release of and the media in which such statement or announcement is to be made; provided, however, that in the case of announcements, statements, acknowledgments or revelations which either party is required by law to make, issue or release, the making, issuing or releasing of any such announcement, statement, acknowledgment or revelation by the party so required to do so by law shall not constitute a breach of this Agreement if such party shall have given, to the extent reasonably possible, not less than five (5) business days prior notice to the other party (except in the case of media inquiries (which shall require a lesser amount of time), if such party shall have used its reasonable best efforts to notify the other party), and shall have attempted, to the extent reasonably possible, to clear such announcement, statement, acknowledgment or revelation with the other party. Notwithstanding the foregoing, the parties acknowledge that there may be a need to engage in daily or frequent contact with government agencies and/or other Third Parties which may make inquiries with respect to this Agreement after its initial public disclosure. This Section 14 is not intended to prohibit responding to such inquiries so long as any such responses shall remain consistent with the statements and other public relations material which has been approved by the parties in accordance with this Section 14, and the maximum advanced notice possible is provided with respect to media inquiries (if less than the previously outlined 5-day notification period). To the extent reasonably possible, the parties shall coordinate with each other on any such subsequent responses.
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14.2 The parties acknowledge that as of the date hereof, they have agreed upon the text of press releases with respect to this Agreement in the forms attached as Exhibit E.
14.3 Purchaser shall not use the name of Seller or any of its Affiliates for advertising, promotional or other purposes without the prior written consent of Seller. In furtherance of the foregoing, Purchaser shall not originate any publicity or other announcement, written or oral, whether to the public, the press, the trade, Purchaser’s or Seller’s customers or otherwise, relating to this Agreement or the existence of an arrangement between the parties, without the prior written approval of Seller, except as otherwise permitted under the terms of this Agreement. Any breach of the terms of this Agreement by Purchaser shall be deemed a material breach of this Agreement.
SECTION 15
REPRESENTATIONS AND WARRANTIES
15.1 Product Warranties. Seller represents and warrants to Purchaser that all Products supplied in connection with this Agreement shall be manufactured and provided in accordance and conformity with the Specifications. Seller represents and warrants that it shall comply with all present and future statutes, laws, ordinances and regulations relating to the manufacture and supply of the Product being provided hereunder, including, without limitation, those enforced by the FDA (including compliance with good manufacturing practices) and the DEA. Seller further represents and warrants that, to its knowledge and as of the date of this Agreement, the manufacture of Products by Seller does not infringe any patent of any third party. SELLER MAKES NO OTHER REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY OTHER MATTER WITH RESPECT TO THE PRODUCT.
15.2 LIMITATION ON LIABILITY OF SELLER. IN THE EVENT THAT (I) ANY PRODUCT DOES NOT MEET THE SPECIFICATIONS THEREFOR, OR (II) SELLER HAS OTHERWISE BREACHED THIS AGREEMENT, THEN THE LIABILITY OF SELLER HEREUNDER TO PURCHASER (INCLUDING, BUT NOT LIMITED TO, CLAIMS OR COSTS RELATED TO PRODUCT LIABILITY CLAIMS OR OTHERWISE), SHALL NOT, (X) WITH RESPECT TO THOSE CLAIMS BASED UPON THE PRECEDING CLAUSE (I), EXCEED $[**] MILLION PER OCCURRENCE AND $[**] MILLION IN THE AGGREGATE ANNUALLY AND (Y) WITH RESPECT TO THOSE CLAIMS BASED UPON THE PRECEDING CLAUSE (II), EXCEED $[**] MILLION (EXCEPT AS PROVIDED IN SECTION 15.3(B)).
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidentiality and filed separately with the Securities and Exchange Commission.
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15.3 LIMITATION ON LIABILITY OF PARTIES.
(A) EXCEPT AS EXPRESSLY PROVIDED IN SECTION 15.3(B), IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OR FOR ANY LOSS OF PROFITS OR REVENUES ARISING OUT OF OR RESULTING FROM ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE.
(B) THE LIMITATIONS AND DISCLAIMER SET FORTH IN (I) THE PRECEDING CLAUSE (A) FOR LOSS OF PROFITS AND (II) SECTION 15.2(Y) (AS IT RELATES TO THE $[**] MILLION AMOUNT), SHALL NOT APPLY TO A CLAIM BY PURCHASER AGAINST SELLER FOR DAMAGES RESULTING FROM AN INTENTIONAL BREACH OF THIS AGREEMENT BY SELLER OF ITS OBLIGATION TO SUPPLY PRODUCT TO PURCHASER IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT ONLY IF ALL OF THE FOLLOWING CRITERIA ARE SATISFIED BY SUCH CLAIM:
(V) | THE CLAIM RELATES TO A TIME PERIOD DURING WHICH SELLER HAD SUFFICIENT QUANTITIES OF THE PRODUCTS TO PROVIDE TO PURCHASER AS SET FORTH IN THIS AGREEMENT (UNLESS THE SELLER HAS FAILED TO MAINTAIN SUFFICIENT QUANTITIES OF PRODUCTS FOR THE PURPOSE OF WITHHOLDING IT FROM PURCHASER), AND |
(W) | DURING SUCH TIME PERIOD, SELLER SOLD THE NDA PRODUCT IN THE TERRITORY, AND |
(X) | DURING SUCH TIME PERIOD, SELLER INTENTIONALLY BREACHED THIS AGREEMENT BY WITHHOLDING THE PRODUCTS FROM PURCHASER FOR A PERIOD OF AT LEAST THREE (3) MONTHS FOR THE PURPOSE OF SELLING MORE OF THE NDA PRODUCT IN THE TERRITORY THAN SELLER WOULD HAVE OTHERWISE SOLD IN LIEU OF SUPPLYING THE PRODUCTS TO PURCHASER IN ACCORDANCE WITH THIS AGREEMENT, AND |
(Y) | DURING SUCH TIME PERIOD, A FORCE MAJEURE EVENT AS DESCRIBED IN SECTION 11.1 DID NOT APPLY, AND |
(Z) | DURING SUCH TIME PERIOD, PURCHASER WAS NOT IN BREACH OF THIS AGREEMENT. |
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidentiality and filed separately with the Securities and Exchange Commission.
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PROVIDED, HOWEVER, IN NO EVENT SHALL SELLER BE LIABLE TO PURCHASER FOR DAMAGES IN EXCESS OF $[**] (THE “TOTAL CAP”) IN THE AGGREGATE. PURCHASER AGREES TO SUBMIT ANY CLAIM FOR DAMAGES PURSUANT TO THIS SECTION 15.3 FOR RESOLUTION BY ARBITRATION AS SET FORTH IN SECTION 17.2.
(C) WITH RESPECT TO ANY CLAIM FOR DAMAGES AS PROVIDED IN SECTION 15.3(B), PURCHASER ACKNOWLEDGES AND AGREES TO THE FOLLOWING:
(I) | THAT THE TOTAL CAP SET FORTH ABOVE IS NOT INTENDED TO BE AND SHALL NOT BE DEEMED TO BE A LIQUIDATED DAMAGES AMOUNT; |
(II) | THAT THE ARBITRATION PANEL SET FORTH IN SECTION 17.2 SHALL DETERMINE WHETHER ALL OF THE CRITERIA SET FORTH IN SECTION 15.3(B) HAVE BEEN MET AND WHETHER PURCHASER IS ENTITLED TO DAMAGES, INCLUDING LOSS OF PROFITS, PURSUANT TO SECTION 15.3(B) IN ACCORDANCE WITH LAW; |
(III) | THAT PURCHASER MUST ESTABLISH THE ACTUAL AMOUNT OF ITS DAMAGES IN ACCORDANCE WITH APPLICABLE LAW, AND SHALL NOT BE ENTITLED TO RECOVER DAMAGES TO THE EXTENT PURCHASER IS ABLE TO MITIGATE ITS DAMAGES, INCLUDING, WITHOUT LIMTATION, BY SECURING A COVER SOURCE FOR THE PRODUCTS; AND |
(IV) | THAT SECTIONS 15.2(II), 15.2(Y) AND THE PROVISO AT THE END OF 15.3(B) SHALL BE REDACTED AND NOT OTHERWISE DISCLOSED IN ANY ARBITRATION PROCEEDING AND SHALL BE APPLIED BY THE PARTIES IF AND AFTER A FINAL DAMAGE AMOUNT IS AWARDED. |
(D) FOR THE AVOIDANCE OF DOUBT, PURCHASER AGREES IT IS NOT ENTITLED TO CLAIM DAMAGES IN EXCESS OF THE LIMITS SET FORTH IN SECTION 15.2 OR LOSS OF PROFITS FOR ANY PRODUCT THAT SELLER HAS SUPPLIED THAT DOES NOT MEET THE SPECIFICATIONS THEREFOR.
15.4 Execution and Performance of Agreement. Seller and Purchaser each represents to the other that it has full right, power and authority to enter into and perform its obligations under this Agreement. Seller and Purchaser each further represents and warrants to the other that the performance of its obligations under this Agreement will not result in a violation or breach of, and will not conflict with or constitute a default under any agreement, contract, commitment or obligation to which such party or any of its Affiliates is a party or by which it is bound.
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SECTION 16
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SECTION 17
17.1 Executive Resolution. If any dispute arises between the parties relating to the interpretation, breach or performance of this Agreement or the grounds for the termination thereof, the parties agree that before submitting such dispute to arbitration as set forth in Section 17.2 below, the Presidents (or equivalent level) of each party shall, for a period of thirty (30) days after such dispute is formally submitted to either of such Presidents in writing, attempt in good faith to negotiate a resolution of the dispute. The foregoing shall not be interpreted to preclude either party from seeking and obtaining from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the dispute.
17.2.1 Any dispute, claim or controversy arising from or related in any way to this Agreement or the interpretation, application, breach, termination or validity thereof, including any claim of inducement of this Agreement by fraud or otherwise, will be submitted for resolution by arbitration pursuant to the rules then pertaining of the CPR Institute for Dispute Resolution for Non-Administered Arbitration (available at xxx.xxxxxx.xxx/xxx-xxxxx.xxx), or successor (“CPR”), except where those rules conflict with these provisions, in which case these provisions control. The arbitration will be held in the City of New York, Borough of New York, New York.
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17.2.2 The panel shall consist of three arbitrators chosen from the CPR Panels of Distinguished Neutrals (or, by agreement, from another provider of arbitrators) each of whom is a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction. In the event the aggregate damages sought by the claimant are stated to be less than $5 million, and the aggregate damages sought by the counterclaimant are stated to be less than $5 million, and neither side seeks equitable relief, then a single arbitrator shall be chosen, having the same qualifications and experience specified above. Each arbitrator shall be neutral, independent, disinterested, impartial and shall abide by The CPR-Georgetown Commission Proposed Model Rule for the Lawyer as Neutral available at xxx.xxxxxx.xxx/xxx-xxxxxx.xxxx.
17.2.3 The parties agree to cooperate (1) to attempt to select the arbitrator(s) by agreement within 45 days of initiation of the arbitration, including jointly interviewing the final candidates, (2) to meet with the arbitrator(s) within 45 days of selection and (3) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than nine (9) months after selection of the arbitrator(s) and in the award being rendered within 60 days of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within 45 days after the conclusion of the hearings.
17.2.4 In the event the parties cannot agree upon selection of the arbitrator(s), the CPR will select arbitrator(s) as follows: CPR shall provide the parties with a list of no less than 25 proposed arbitrators (15 if a single arbitrator is to be selected) having the credentials referenced above. Within 25 days of receiving such list, the parties shall rank at least 65% of the proposed arbitrators on the initial CPR list, after exercising cause challenges. The parties may then interview the five candidates (three if a single arbitrator is to be selected) with the highest combined rankings for no more than one hour each and, following the interviews, may exercise one peremptory challenge each. The panel will consist of the remaining three candidates (or one, if one arbitrator is to be selected) with the highest combined rankings. In the event these procedures fail to result in selection of the required number of arbitrators, CPR shall select the appropriate number of arbitrators from among the members of the various CPR Panels of Distinguished Neutrals, allowing each side challenges for cause and three peremptory challenges each.
17.2.5 In the event the parties cannot agree upon procedures for discovery and conduct of the hearing meeting in the schedule set forth in Section 17.2.3 above, then the arbitrator(s) shall set dates for the hearing, any post-hearing briefing, and the issuance of the award in accord with the schedule set out in Section 17.2.3. The arbitrator(s) shall provide for discovery according to those time limits, giving recognition to the understanding of the parties that they contemplate reasonable discovery, including document demands and depositions, but that such discovery be limited so that the schedule set out in Section 17.2.3 may be met without difficulty. In no event will the arbitrator(s), absent agreement of the parties,
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allow more than a total of ten days for the hearing or permit either side to obtain more than a total of 40 hours of deposition testimony from all witnesses, including both fact and expert witnesses, or serve more than 20 individual requests for documents, including subparts, or 20 individual requests for admission or interrogatories, including subparts. Multiple hearing days will be scheduled consecutively to the greatest extent possible.
17.2.6 The arbitrator(s) must render their award by application of the substantive law of the State of New Jersey and are not free to apply “amiable compositeur” or “natural justice and equity.” The arbitrator(s) shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. A transcript of the evidence adduced at the hearing shall be made and shall, upon request, be made available to either party. The arbitrator(s) shall have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundancy, or irrelevance and no award shall be overturned by reason of such ruling on evidence. To the extent possible, the arbitration hearings and award will be maintained in confidence.
17.2.7 In the event the panel’s award exceeds $5 million in monetary damages or includes or consists of equitable relief, or rejects a claim in excess of that amount or for that relief, then the losing party may obtain review of the arbitrators’ award or decision by a single appellate arbitrator (the “Appeal Arbitrator”) selected from the CPR Panels of Distinguished Neutrals by agreement or, failing agreement within seven working days, pursuant to the selection procedures specified in Section 17.2.4 above. If CPR cannot provide such services, the parties will together select another provider of arbitration services that can. No Appeal Arbitrator shall be selected unless he or she can commit to rendering a decision within forty-five days following oral argument as provided in this paragraph. Any such review must be initiated within thirty (30) days following the rendering of the award referenced in Section 17.2.6 above.
17.2.8 The Appeal Arbitrator will make the same review of the arbitration panel’s ruling and its bases that the U.S. Court of Appeals of the Circuit where the arbitration hearings are held would make of findings of fact and conclusions of law rendered by a district court after a bench trial and then modify, vacate or affirm the arbitration panel’s award or decision accordingly, or remand to the panel for further proceedings. The Appeal Arbitrator will consider only the arbitration panel’s findings of fact and conclusions of law, pertinent portions of the hearing transcript and evidentiary record as submitted by the parties, opening and reply briefs of the party pursuing the review, and the answering brief of the opposing party, plus a total of no more than four (4) hours of oral argument evenly divided between the parties. The party seeking review must submit its opening brief and any reply brief within seventy-five (75) and one hundred thirty (130) days, respectively, following the date of the award under review, whereas the opposing party must submit its responsive brief within one hundred ten (110) days of that date. Oral argument shall take place within five (5) months after the date of the award under review, and the Appeal
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Arbitrator shall render a decision within forty-five (45) days following oral argument. That decision will be final and not subject to further review, except pursuant to the Federal Arbitration Act.
17.2.9 The parties consent to the jurisdiction of the Federal District Court for the district in which the arbitration is held for the enforcement of these provisions and the entry of judgment on any award rendered hereunder (including after review by the Appeal Arbitrator where such an appeal is pursued). Should such court for any reason lack jurisdiction, any court with jurisdiction shall act in the same fashion.
17.2.10 Each party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.
17.2.11 EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY.
17.2.12 EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR MULTIPLIED DAMAGES FROM THE OTHER.
17.2.13 EXCEPT TO THE EXTENT LOSS OF PROFITS AS PROVIDED IN SECTION 15.3(B) ARE DEEMED CONSEQUENTIAL DAMAGES IN ACCORDANCE WITH APPLICABLE LAW, EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES FROM THE OTHER.
17.2.14 EACH PARTY HERETO WAIVES ANY CLAIM FOR ATTORNEYS’ FEES AND COSTS AND PREJUDGMENT INTEREST FROM THE OTHER.
17.2.15 EXCEPT AS OTHERWISE PROVIDED IN SECTION 15.3(B), EACH PARTY HERETO WAIVES ANY CLAIM FOR LOSS OF PROFITS FROM THE OTHER.
SECTION 18
18.1 Relationship of the Parties. The relationship of Purchaser and Seller established by this Agreement is that of independent contractors, and nothing contained herein shall be construed to (i) give either party any right or authority to create or assume any obligation of any kind on behalf of the other or (ii) constitute the parties as partners, joint venturers, co-owners or otherwise as participants in a joint or common undertaking.
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18.2 Third Party Rights. Nothing in this Agreement shall be deemed to create any third party beneficiary rights in or on behalf of any other person.
If to Seller:
Xxxxxx Laboratories, Inc.
000 Xxxxx Xxxxxx Xxxxxx
Xxxxxxxxxx, XX, 00000
Attention: President and Chief Operating Officer
With a copy to:
Xxxxxx Pharmaceuticals, Inc.
000 Xxxxxx Xxxxxx
Xxxxxx, XX 00000-0000
Attention: General Counsel
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If to Seller:
Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc.
0000 Xxxxxxx-Xxxxxxxxxx Xx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attention: President
With a copy to:
Xxxxxxx & Xxxxxxx
Office of General Counsel
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Attention: General Counsel
or to such other place as either party may designate by written notice to the other in accordance with the terms hereof.
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extent the economic benefits conferred by this Agreement to both parties remain substantially unimpaired, not affect the validity, legality or enforceability of any of the terms or provisions of this Agreement in any other jurisdiction.
18.12 Survival. Sections 3.5, 7.6, 13, 14, 15, 16, 17 and 18 shall survive the termination of this Agreement in accordance with the respective terms thereof.
[Signature Page Follows]
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XXXXXX LABORATORIES, INC. | ||
By: | /s/ R. Xxxx Xxxxx | |
Name: R. Xxxx Xxxxx | ||
Title: Senior Vice President & Chief Financial Officer |
ORTHO-XXXXXX-XXXXXXX PHARMACEUTICALS, INC.
By: | /s/ Xxxxxx X. Xxxxxx | |
Name: Xxxxxx X. Xxxxxx | ||
Title: Vice President and General Manager, CNS |
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LIST OF EXHIBITS
Product
Purchase Prices
Initial Order
Production Capacity or Raw Material Shortage Allocation Press Release
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EXHIBIT A
Products
18 mg dosage in 100 count bottles
27 mg dosage in 100 count bottles
36 mg dosage in 100 count bottles
54 mg dosage in 100 count bottles
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidentiality and filed separately with the Securities and Exchange Commission.
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EXHIBIT B
Purchase Prices
Quarterly Period | Purchase Price as a Percent of Purchaser Net Sales | |||
Start Date - June 30, 2011 | [ | **]% | ||
July 1, 2011 - September 30, 2011 | [ | **]% | ||
October 1, 2011 - December 31, 2011 | [ | **]% | ||
January 1, 2012 - March 31, 2012 | [ | **]% | ||
April 1, 2012 until the end of the term of the Agreement | [ | **]% |
Notwithstanding the foregoing, the purchase price would be reduced to [**] percent of Xxxxxx’x Net Sales during any period between the Start Date and March 31, 2012 when a third party AB-rated version of the NDA Product is available for sale in the Territory. Further, the purchase price would be reduced to [**] percent of Xxxxxx’x Net Sales during any period between July 1, 2012 and December 31, 2014 when a third party AB-rated version of the NDA Product is available for sale in the Territory.
Minimum Amount - All Prices are for Bottles of 100
18 mg - [$[**]]
27 mg - [$[**]]
36 mg - [$[**]]
54 mg - [$[**]]
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidentiality and filed separately with the Securities and Exchange Commission.
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EXHIBIT C
Initial Order
The parties acknowledge that the amount of Purchaser’s Initial Order will depend on whether Seller receives the additional Product raw material quota allocation which Seller has requested from the DEA. In the event Seller receives the additional Product raw material allocation it requested from the DEA by November 15, 2010, Purchaser will thereafter place its initial Order for the amounts of Products as set forth below under the column “Projected Deliveries with Incremental API Quota requested from DEA”. In the event Seller does not receive the additional Product raw material allocation it required from the DEA by November 15, 2010, Purchaser shall place its Initial Order for the amounts of Products as set forth below under the column “Projected Deliveries without Incremental API Quota requested from DEA”.
Strength | Delivery Date | Projected Deliveries without Incremental API Quota requested from DEA | Projected Deliveries with Incremental API Quota requested from DEA | |||||
15-Apr | [**] | [**] | ||||||
18mg | ||||||||
1-May | [**] | [**] | ||||||
1-Jun | [**] | [**] | ||||||
1-Jul | [**] | [**] | ||||||
1-Aug | [**] | [**] | ||||||
27mg | 15-Apr | [**] | [**] |
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidentiality and filed separately with the Securities and Exchange Commission.
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1-May | [**] | [**] | ||||||
1-Jun | [**] | [**] | ||||||
1-Jul | [**] | [**] | ||||||
1-Aug | [**] | [**] | ||||||
36mg | 15-Apr | [**] | [**] | |||||
1-May | [**] | [**] | ||||||
1-Jun | [**] | [**] | ||||||
1-Jul | [**] | [**] | ||||||
1-Aug | [**] | [**] | ||||||
54mg | 15-Apr | [**] | [**] | |||||
1-May | [**] | [**] | ||||||
1-Jun | [**] | [**] | ||||||
1- Jul | [**] | [**] | ||||||
1-Aug | [**] | [**] |
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Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidentiality and filed separately with the Securities and Exchange Commission.
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EXHIBIT D
Production Capacity and Raw Material Shortage Allocations
Start Date – May 31, 2011:[**] Percent to Purchaser
June 1, 2011 – June 30, 2011: [**] Percent to Purchaser
July 1, 2011 – July 31, 2011: [**] Percent to Purchaser
August 1, 2011 – until the end of the term of the Agreement: [**] Percent to Purchaser
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EXHIBIT E
Press Release
Draft
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NEWS RELEASE | DRAFT 10-27-10 | |||||
CONTACTS: | Investors: | |||||
Xxxxx Xxxxxxxxx | ||||||
(000) 000-0000 | ||||||
Media: | ||||||
Xxxxxxx Xxxx | ||||||
(000) 000-0000 |
Xxxxxx Signs Exclusive Agreement to Distribute Authorized Generic Concerta®
MORRISTOWN, NJ — October XX, 2010 — Xxxxxx Phamiaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Xxxxxx Laboratories, Inc., has entered into an exclusive agreement with Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc., to market the authorized generic version of Concerto® (methylphenidate hydrochloride extended-release tablets). Xxxxxx will launch its authorized generic of Concerta’ on May 1, 2011. Concerta is used to treat attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD).
Under the terms of the agreement, Ortho-XxXxxx-Xxxxxxx will manufacture and exclusively supply Xxxxxx with all dosage strengths of the authorized generic product. Xxxxxx will market and distribute the product in the United States. Ortho-XxXxxx-Xxxxxxx will receive a share of the net sales from Xxxxxx’x sales of the product. The agreement runs until the end of 2014. During the term of the agreement, Xxxxxx will be permitted to continue to pursue U.S. Food and Drug Administration approval of its abbreviated new drug application (ANDA) for a generic version of Concerta and will be permitted to launch its own ANDA product at the conclusion of the exclusive supply agreement. Other terms of the agreement were not disclosed.
This agreement ensures that consumers will benefit from a quality, cost effective product beginning in May 2011, removing any uncertainty of when a generic product could be approved,” said Xxxx Xxxxxx, Xxxxxx’x President and CEO.
For the 12-months ending June 30, 2010, Concerte had sales of approximately $1.3 billion, according to IMS Health data.
About Xxxxxx Pharmaceuticals, Inc.
Xxxxxx Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women’s Health. Xxxxxx has operations in many of the world’s established and growing international markets.
For press release and other company information, visit Xxxxxx Pharmaceuticals’ Web site at xxxx://xxx.xxxxxx.xxx.
Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Xxxxxx’x current perspective of existing information as of the date of this release. It is important to note that Xxxxxx’x goals and expectations are not predictions of actual performance. Actual results may differ materially from Xxxxxx’x current expectations depending upon a number of factors, risks and uncertainties affecting Xxxxxx’x business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Xxxxxx and its third party manufacturers’ facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Xxxxxx’x periodic public filings with the Securities and Exchange Commission, including but not limited to Xxxxxx’x annual report on Form 10-K for the year ended December 31,2009 and Xxxxxx’x quarterly report on Form 10-Q for the period ended June 30, 2010. Except as expressly required by law, Xxxxxx disclaims any intent or obligation to update these forward-looking statements.
Concerta® is a registered trademark of Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc.
Privileged and Confidential
Not for Distribution or External
Disclosure REVISED FINAL: November 1, 2010
Contacts:
Media | Investors | |||
Xxxx Xxxxxxx: (000) 000-0000 | Xxxxxx Xxxxxxxx: (000) 000-0000 | |||
Xxxx Xxxxxxxxxx: (000) 000-0000 |
Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc. Enters into Agreement for
CONCERTA® Authorized Generic
Titusville, NJ (November 2, 2010) — Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc. (OMJPI) today announced it has entered into a supply and distribution agreement with Xxxxxx Laboratories, Inc. to distribute an authorized generic version of CONCERTA® (methylphenidate HCI extended-release tablets). Xxxxxx will launch the authorized generic beginning May 1, 2011.
“The availability of an authorized generic version of CONCERTA that is both bioequivalent and clinically equivalent to the complex, extended-release innovator compound is particularly important — and reassuring — for patients with ADHD and their families,” states Xxx Xxxxx, Vice President Clinical Pharmacology, Neurosciences, Xxxxxxx & Xxxxxxx Pharmaceutical Research & Development, L.L.C. “It is also important for healthcare professionals who may consider prescribing a generic product for this condition.”
In 2004, the affiliate of OMJPI that marketed CONCERTA at that time filed a Citizen Petition requesting generic versions of CONCERTA demonstrate a similar onset of efficacy and a similar duration of effect to the innovator product. The Citizen Petition, which remains under review by the Food and Drug Administration (FDA), is not impacted by this agreement. XxXxxx Pediatrics, a division of OMJPI, will continue to market the branded CONCERTA® product.
Under the terms of the agreement, OMJPI will manufacture and exclusively supply Xxxxxx with the authorized generic product, which will be available in 18mg, 27mg, 36mg, and 54mg formulations. Xxxxxx will market and distribute the product in the United States until the end of 2014.
CONCERTA is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies.
IMPORTANT SAFETY INFORMATION
Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.
CONCERTA should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA; significant anxiety, tension, or agitation; glaucoma; tics, Tourette’s syndrome, or family history of Tourette’s syndrome; current or past use of monoamine oxidase inhibitor (MAGI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA.
Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA. Your child’s healthcare professional should check height and weight often and may interrupt CONCERTA treatment if your child is not growing or gaining weight as expected.
Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA does not adversely affect your ability to engage in such activities.
The most common adverse reaction (>5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.
CONCERTA contains methylphenidate, a Schedule II controlled substance under the Controlled Substances Act.
For full prescribing information, go to xxx.xxxxxxxx.xxx.
Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc., a subsidiary of Xxxxxxx & Xxxxxxx, provides medicines for an array of health concerns. The company strives to provide innovative, high quality, safe and effective treatments and continually seeks new opportunities to offer solutions for unmet health care needs. Ortho XxXxxx-Xxxxxxx Pharmaceuticals, Inc. is headquartered in Titusville, New Jersey.
XxXxxx Pediatrics’”, Division of Ortho-XxXxxx-Xxxxxxx Pharmaceuticals, Inc., is committed to meeting the needs of children, adolescents, adults and healthcare professionals through the development of therapies specifically formulated for children, adolescents and adults. XxXxxx PediatricsTM is a leader in the treatment of ADHD and markets a leading medication prescribed in the United States for children, adolescents and adults with ADHD. The company is headquartered in Titusville, N.J.
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CONCERTA and XXXX’ are registered trademarks of ALZA Corporation.
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Ortho-McNeilJanssen Pharmaceuticals, Inc. and/or Xxxxxxx & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Xxxxxxx & Johnson’s Annual Report on Form 10K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at xxx.xxx.xxx, v.,xx.Xxx.xxx or on request from Xxxxxxx & Xxxxxxx. Neither Ortho-McNeilJanssen Pharmaceuticals, Inc. nor Xxxxxxx & Xxxxxxx undertake to update any forward-looking statements as a result of new information or future events or developments.
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