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SUPPLY AGREEMENT

Supply Agreement

SUPPLY AGREEMENT | Document Parties: SAVIENT PHARMACEUTICALS INC You are currently viewing:
This Supply Agreement involves

SAVIENT PHARMACEUTICALS INC

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Title: SUPPLY AGREEMENT
Governing Law: Delaware     Date: 3/16/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

SUPPLY AGREEMENT, Parties: savient pharmaceuticals inc
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Exhibit 10.25

CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.

SUPPLY AGREEMENT

BETWEEN

WATSON PHARMA, INC.

AND

SAVIENT PHARMACEUTICALS, INC.

 


 

Table of Contents

 

 

 

 

 

SECTION 1 DEFINITIONS

 

 

i

 

SECTION 2 SUPPLY AND PURCHASE OF PRODUCTS

 

iii

SECTION 3 PRICING

 

vi

SECTION 4 FORECASTS, ORDERS

 

viii

SECTION 5 SPECIFICATIONS

 

ix

SECTION 6 TERM

 

xii

SECTION 7 TERMINATION

 

xii

SECTION 8 DELIVERY; INVENTORY

 

xv

SECTION 9 DEFECTIVE PRODUCTS

 

xv

SECTION 10 REGULATORY MATTERS

 

xvi

SECTION 11 FORCE MAJEURE

 

xix

SECTION 12 INSURANCE

 

xix

SECTION 13 CONFIDENTIALITY

 

xx

SECTION 14 PUBLIC ANNOUNCEMENTS

 

xx

SECTION 15 REPRESENTATIONS AND WARRANTIES

 

xxi

SECTION 16 INDEMNIFICATION

 

xxii

SECTION 17 DISPUTE RESOLUTION

 

xxiii

SECTION 18 MISCELLANEOUS

 

xxiii

LIST OF EXHIBITS

A. Product, Specifications and Packaging

B. Initial Finished Product Prices

C. Adverse Event Reporting Procedures

D. Initial Purchase Order Forecast

E. Quality Requirements

F. Form of Press Release

 


 

SUPPLY AGREEMENT

      SUPPLY AGREEMENT , dated as of June 12, 2006, by and between Savient Pharmaceuticals, Inc., a Delaware corporation (“ Seller ”), and Watson Pharma, Inc., a Delaware corporation (“ Purchaser ”).

      WHEREAS , Seller would like to make and sell the Products (as defined below) to Purchaser, and Purchaser would like to purchase the Products from Seller pursuant to the terms of this Agreement;

      NOW, THEREFORE , in consideration of the mutual promises, covenants and agreements hereinafter set forth, the parties hereto agree as follows:

SECTION 1

DEFINITIONS

     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 given in Section 2.2.3.

     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. For the purposes of this definition, the term “controls” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to any Party, shall mean the possession (directly or indirectly) of more than 50% of the outstanding voting securities or other equity or voting interest of an entity.

     1.3 “ ANDA ” shall mean an Abbreviated New Drug Application filed with the FDA.

     1.4 “ Bankruptcy Code ” shall have the meaning given in Section 7.3.

     1.5 “ Bankruptcy Law ” shall have the meaning given in Section 7.3.

     1.6 “ Commercially Reasonable Efforts ” shall mean, with respect to a Party, those commercially reasonable efforts that such Party is making in similar circumstances relative to other products in its portfolio with respect to production and/or marketing, distribution and sales of its own products that are in production or that are being marketed, distributed and sold at that time, as applicable. Commercially Reasonable Efforts shall be in accordance with the efforts and resources that the Party would use for a product owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life, taking into account the competitiveness of the marketplace, the proprietary position of the applicable active ingredient, the regulatory structure involved, and the profitability of the product.

     1.7 “ Damages ” shall have the meaning given in Section 16.1.

     1.8 “Delivery Price” shall have the meaning given in Section 3.1.

     1.9 “ Effective Date ” shall mean the date of this Agreement.

i


 

     1.10 “ Equivalent Product ” shall mean any product, other than a Product that Seller is obligated to supply to Purchaser hereunder, which (i) is manufactured by a Party pursuant to an ANDA which was approved by the FDA, which ANDA was filed on the basis of the original NDA for the brand equivalent of such Product or (ii) is otherwise a generic version of the brand equivalent of such Product.

     1.11 “ Existing Inventory ” shall mean all Product manufactured by Seller into final tableted form prior to [**] with the following lot numbers: A18061; C400715; C400721; C500173; C500174; C500175, and; 4A3069.

     1.12 “ FDA ” shall mean the U.S. Food and Drug Administration, and any successor or replacement agency.

     1.13 “ Finished Product Price ” shall mean the aggregate cost to manufacture and/or Label Product, on a batch by batch basis,

 

 

 

     (i) if Product is manufactured and/or Labeled by Seller or an Affiliate of Seller the sum of Seller’s (a) [**], (b) [**] and (c) [**]; or

 

 

 

     (ii) if such Product is manufactured and/or Labeled by a Third Party manufacturer, the sum of (a) [**] and (b) [**].

All costs included in Manufacturing Costs shall be calculated in accordance with U.S. generally accepted accounting principles, consistently applied to the manufacture of all products produced in the facility or facilities in which such Product is manufactured and/or Labeled. [**]

     1.14 “ Force Majeure Event ” shall have the meaning given in Section 11.

     1.15 “ Gross Margin” shall have the meaning given in Section 3.1.

     1.16 “ Indemnity Claim ” shall have the meaning given in Section 16.3.

     1.17 “ Initial Purchase Order ” shall have the meaning given in Section 2.2.1.

     1.18 “ Label ”, “ Labeled ” or “ Labeling ” shall mean all labels and other written, printed or graphic matter upon (i) any packaging, container or wrapper utilized with the Products, or (ii) any written material accompanying the Products, including package inserts; or as the context requires, the act of applying and/or using the same.

     1.19 “ Latent Defect ” shall mean any instance where a lot of a Product fails to conform to the applicable Specifications or is otherwise defective or fails to conform to the warranties given by Seller herein, and such failure would not be discoverable upon reasonable physical inspection or standard testing of such Product upon receipt by Purchaser in accordance with Purchaser’s standard operating procedures.

     1.20 “ Launch Quantity ” shall have the meaning given in Section 2.2.1.

     1.21 “ Material Change ” shall have the meaning given in Section 5.2.1

     1.22 “ NDA ” shall mean a New Drug Application filed with the FDA.

     1.23 “ Net Sales ” shall mean, with respect to any Product, the revenues derived from the sale by Purchaser, its Affiliates, licensees and assignees from the sale of a Product to independent third parties, less: (i) all normal and customary discounts (such as cash discounts, volume discounts, chargebacks, allowances (including shelf stock adjustments and promotional allowances that are not selling or marketing-related operational expenses), government mandated rebates and other rebates, credits, and Product returns), (ii) freight, shipping, insurance costs relating to the shipment of the Product, duties and taxes; and (iii) bad debt related to the Product (as such bad debts are actually

 


 

incurred). Net Sales shall be determined on an accrual basis (except for clause (iii) above) in accordance with generally accepted accounting principles in the Territory, applied on a basis consistent with Purchaser’s annual audited financial statements. Subject to the foregoing, Purchaser will not deduct any marketing, selling, advertising or distribution expenses of any kind to determine Net Sales.

     1.24 “ Packaging ” shall mean all primary containers, Labels, cartons, shipping cases or any other like matter used in packaging or accompanying the Products; or as the context requires, the act of applying and/or using the same.

     1.25 “ Party ” shall mean Seller or Purchaser and, when used in the plural, shall mean Seller and Purchaser.

     1.26 “ Patent Defect ” shall mean any instance where a lot of a Product fails to conform to the applicable Specifications or is otherwise defective or fails to conform to the warranties given by Seller herein, and such failure is discoverable upon reasonable physical inspection or standard testing of such Product upon receipt by Purchaser in accordance with Purchaser’s standard operating procedures.

     1.27 “ Product ” or “ Products ”, as applicable, shall mean each of oxandrolone 2.5mg tablets (the “2.5mg Product”) and oxandrolone 10mg tablets (the “10mg Product”), collectively the Products and, any other products the parties agree to include herein; Product shall not include any branded version of oxandrolone either currently offered for sale or offered for sale in the future by Seller, whether or not of the same dosage strength or form.

     1.28 “ Purchase Price ” shall have the meaning give in Section 3.1.

     1.29 “ Purchaser Trademarks ” shall have the meaning given in Section 5.4.

     1.30 “ Quality Requirements ” shall have the meaning give in Section 5.3.

     1.31 “ Remainder Payment ” shall have the meaning given in Section 3.1.

     1.32 “ Specifications ” shall mean the specifications for the design, composition, manufacture, packaging, and/or quality control of each of the Products, as set forth on Exhibit A attached hereto and made a part hereof, as the same may hereafter be modified by mutual agreement of the parties in writing.

     1.33 “ Start Date ” shall have the meaning given in Section 2.2.3.

     1.34 “ Territory ” shall mean the United States of America, including its territories and possessions and military bases and possessions (including, but not limited to, the Commonwealth of Puerto Rico).

SECTION 2

SUPPLY AND PURCHASE OF PRODUCTS

     2.1 Supply and Purchase Obligations .

          2.1.1 During the Distribution Term, Seller shall manufacture, or have manufactured by a third party, and exclusively supply Purchaser with Products for sale and distribution in the

 


 

Territory. Seller shall supply Purchaser with those quantities of Products as are ordered by Purchaser pursuant to this Agreement. In the event Seller has any Product manufactured by an unaffiliated third party, Seller shall (i) notify the Purchaser as to the identity of the third party manufacturer prior to the commencement of supply, and (ii) use its best efforts to obtain from such third party manufacturer rights for the benefit of Purchaser as set forth in Section 5.3, 5.5, 10.3, 10.4, 10.9 and 10.10 hereto. During the Distribution Term (subject to the provisions of Section 4.5) Purchaser shall purchase from Seller 100% of Purchaser’s requirements for the Products in the Territory.

          2.1.2 During the Distribution Term (and subject to the provisions of Section 4.5), Purchaser shall purchase from Seller the Products solely for distribution and sale in the Territory. During the Term, Seller and its Affiliates shall not, and shall not directly or indirectly grant to any other person or entity the right to, sell or distribute the Products and/or Equivalent Product in the Territory, and Seller shall not directly or indirectly cooperate with any other person or entity with respect to, or supply products or services for, the sale or distribution of the Products and/or Equivalent Product in the Territory. Nothing in this Agreement shall prevent the Seller from marketing or selling, or granting third parties the right to market or sell (i) any formulation, dosage or strength of oxandrolone, utilizing any method of delivery, under the brand name Oxandrin® or (ii) any other branded formulations, dosages or strengths of oxandrolone, in each case, other than those Products identified in Exhibit A .

          2.1.3 During the Term, Purchaser shall not, directly or knowingly and indirectly, (i) solicit customers for the Product, or make sales of the Product, or establish or maintain any branch or distribution depot for the Product, outside of the Territory, or assist any party in doing so or (ii) solicit customers for an Equivalent Product, or make sales of an Equivalent Product, or establish or maintain any branch or distribution depot for an Equivalent Product, within the Territory, or assist any party in doing so. If at any time Purchaser, directly or knowingly and indirectly, markets, sells, or distributes the Product outside the Territory, Seller may suspend all sales of the Product to Purchaser until Purchaser takes appropriate actions to cease such sales. At such time as Purchaser learns that a customer is directly or indirectly using, marketing, selling or distributing Products outside of the Territory, or that such customer is assisting any other party to do so, then Purchaser shall cease making sales of Products to such customer until such a time as customer ceases making sales outside of the Territory and Purchaser shall immediately notify Seller in writing of such occurrence and take reasonable actions within its legal rights and powers to cause such third parties to cease making such sales of the Product outside the Territory.

          2.1.4 [ ** ], nothing in this Agreement shall prohibit Purchaser from 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 Product, in each case solely for purposes of seeking regulatory approval for such Equivalent Product; provided , however , that Purchaser shall not be permitted to sell any Equivalent Product which it so manufactures during the Term of this Agreement. [ ** ]

     2.2 Commencement of Supply .

          2.2.1 Seller shall be obligated to commence supply of the Products to Purchaser within ninety (90) days of receipt of a binding purchase order of Products from Purchaser in accordance with the terms and conditions of this Agreement (“Initial Purchase Order”). The quantities in such Initial Purchase Order shall be discussed in good faith and mutually agreed

 


 

between the parties (“Launch Quantity”). Subject to the immediately preceding sentence, the nonbinding forecast for the Initial Purchase Order is attached as Exhibit D to this Agreement. It is further agreed that Seller shall use best commercial efforts to supply a total amount of [**] bottles of the 2.5mg Product, [**], as soon as commercially practicable but in no event later than ninety (90) days from the date of receipt by Purchaser of the Launch Quantities. All orders of Product by Purchaser shall be made in units which comprise whole batch amounts; the delivery of such Product shall be in amounts that reflect the actual batch yield where such yield does not deviate from the defined range ([**] bottles per batch for 2.5mg Product and [**] bottles per batch for 10mg Product).

          2.2.2 Upon receipt of the Initial Purchase Order, Seller shall, as promptly as commercially feasible and using diligent efforts (but in any event no later than ninety (90) days after receipt of such Initial Purchase Order or later date as requested in writing by Purchaser) supply to Purchaser the quantities of the applicable Product which are indicated on the Initial Purchase Order for such Product. In addition to any other right or remedy available to Purchaser, upon any failure by Seller to provide all of the Products in the Initial Purchase Order within the specified and mutually agreed upon time schedule, then Purchaser shall have the right, but not the obligation, to terminate this Agreement, without penalty to either Party, with respect to any or all of such Products (at Purchaser’s discretion) on thirty (30) days prior written notice to Seller.

          2.2.3 The parties agree that they shall cooperate to determine when an Equivalent Product may become available to the marketplace. However, Seller shall, at its sole discretion, designate on which date the Products will be distributed in the Territory by Purchaser (“ Start Date ”) and provide Purchaser with reasonable written notice thereof. It is specifically contemplated and agreed that the 2.5mg Product and the 10mg Product may each have a separate and distinct Start Date based upon the availability of an Equivalent Product in the respective dosage forms, and that Purchaser shall only sell that Product for which Seller has provided explicit approval and for which a designated Start Date has been specified in writing by Seller.

          2.2.4 Prior to the Start Date, Purchaser shall have in place with all significant wholesalers, chain and other drug supply and pharmacy outlets, a communication advising such entities of the Product’s pending availability. Consequently, if any Product supplied to Purchaser under this Agreement is delivered by Purchaser to any third party earlier than two (2) business days prior to the applicable Start Date, then Purchaser shall pay to Seller, as liquidated damages (the “Additional Amount”) an amount equal to (X) the number of units of such Product shipped or distributed by Purchaser to any third party prior to the applicable Start Date times (Y) Seller’s average net selling price for Seller’s branded version of such Product, less (Z) the amounts paid or payable by Purchaser to Seller for such Product under Section 3 below.

          Notwithstanding the foregoing, with Seller’s prior written approval, Purchaser may ship Product to third party purchasers earlier than two (2) business days prior to the Start Date without penalty if such Product is held by third party purchasers thereof in isolation and not available for sale, resale or dispensing until the applicable Start Date; provided, however, that Purchaser shall obtain from any third party purchasers of Product contemplated hereunder binding assurances of non-release prior to the Start Date. To the extent any third party purchaser releases Product for sale, resale or dispensing prior to the Start Date, then Purchaser shall be liable to Seller for the Additional Amount with respect to such Product as calculated above. The Additional Amount shall be Seller’s sole and exclusive remedy (whether arising in contract, tort or otherwise) for the sale prior to the applicable Start Date of any Product by Purchaser and in no event shall such sale be considered or deemed as a breach hereunder. Purchaser shall deliver to Seller written notice of its initial shipment of Product to the retail trade within twenty-four (24) hours of such shipment.

          2.2.5 Seller shall supply to Purchaser, and Purchaser shall accept from Seller subject to all applicable terms and conditions herein, Launch Quantities of Product from Seller’s Existing Inventory provided that such Existing Inventory complies with the terms and conditions of this Agreement. Anything to the contrary notwithstanding, to the extent that any Existing Inventory is sold to Purchaser by Seller and subsequent thereto Purchaser is unable to sell such Existing

 


 

Inventory because its remaining expiry dating is equal to or less than twelve (12) months, Purchaser may return such quantities of Existing Inventory to Seller and Seller shall thereafter, in accordance with the applicable terms and conditions herein, refund to Purchaser one hundred percent (100%) of the Delivery Price actually paid for such quantities as are actually returned to Seller.

SECTION 3

PRICING

     3.1 Purchase Prices . The purchase price (“ Purchase Price ”) paid by Purchaser for each Product delivered by Seller shall be paid in two installments. The first installment (the “ Delivery Price ”) shall be a payment equal to the number of units of such Product delivered by Seller to Purchaser pursuant to [**] of such Product. The second installment (the “ Remainder Payment ”) shall be a quarterly payment equivalent to [**] percent ([**]%) of Purchaser's Gross Margin (as defined below) on the sale of such Product for each calendar quarter during the Term hereof. For purposes of this Agreement “ Gross Margin ” for a particular calendar quarter shall be equivalent to [**] of Product sold during the quarter in question. Purchaser shall provide to Seller within thirty (30) days of the end of each quarter a reasonably detailed report which sets forth the Gross Margin for the quarter just completed.

     3.2 Delivery Price Adjustment . The Delivery Price for Product in effect during any calendar year may be adjusted by Seller upon notice to Purchaser during such calendar year to reflect any actual increase in Seller’s Manufacturing Cost for Product.

     3.3 Shipping Terms . The prices charged by Seller to Purchaser shall be FCA (Incoterms 2000), Seller’s facility in the Territory at which finished goods are packaged for shipment to Purchaser. All deliveries must be accompanied by a packing slip that describes the Products and identifies the purchase order number and the shipment’s destination.

     3.4 Payment Terms . The Delivery Price for each Product shall be paid by Purchaser within sixty (60) days from the date of delivery of such Product. The Remainder Payment shall be paid to Seller within sixty (60) days after the end of each calendar quarter. All payments shall be made in United States dollars.

     3.5 Negative Gross Margin .

          3.5.1 To the extent the Gross Margin is negative in any particular quarter or quarters hereunder Seller shall reimburse Purchaser for [**] percent ([**]%) of the amount of any such negative Gross Margin within sixty (60) days after the end of (i) such calendar quarter or (ii) the expiration or termination of this Agreement, as the case may be.

          3.5.2 For any quarter in which Purchaser claims a negative Gross Margin, Seller shall have the right to have Seller’s independent public accountants (reasonably acceptable to Purchaser) conduct an audit of Purchaser’s financial records, as such information relates to Net Sales and the calculation of Gross Margin with respect to each Product during the quarter in question, for a period of twelve (12) months following receipt of Purchaser’s notice to Seller of such negative Gross Margin; provided, however , that this right may not be exercised more than once in any calendar year. Any audit conducted pursuant to this Section 3.5.2 shall not count against the maximum number of audits to which Seller is entitled pursuant to Section 3.6 herein, and may be conducted by the

 


 

independent public accountants upon the provision of not less than thirty (30) days prior written notice to Purchaser.

     3.6 Annual Audit Rights .

          3.6.1 Purchaser shall keep accurate books and records for purposes of documenting the amount of the Net Sales and the calculation of Gross Margin with respect to each Product. Said books of account shall be kept at Purchaser’s principal place of business. Upon at least thirty (30) days prior written notice given on or before June 30th of each calendar year, Seller, at its expense, shall have the right to have Seller’s independent public accountants (reasonably acceptable to Purchaser) obtain access to Purchaser’s financial records for the previous calendar year, during reasonable business hours solely for the purpose of verifying the amount of Net Sales and the calculation of Gross Margin with respect to each Product for such previous calendar year; provided , however , that this right may not be exercised more than once in any calendar year. Purchaser agrees to reasonably cooperate with Seller’s independent public accountants in the conduct of any such audit. Prior to disclosing the results of any such audit, the auditor shall present Purchaser with a preliminary report of its findings and provide Purchaser with an opportunity to respond to any questions raised or issues identified; provided, however, that Seller shall receive the audit report as originally submitted by independent public accountants along with Purchasers responses thereto to the extent such responses are given pursuant to questions raised in an audit and to the extent that the responses are material to resolving the audit. Seller shall solicit or receive only information relating to the accuracy of such calculations and shall deliver to Purchaser a detailed written accountants’ report (setting forth, among other things, the miscalculations, if any, identified by the audit) within thirty (30) days of completion of the audit. If Seller does not submit a dispute in regards to the amount of Net Sales or Gross Margin so audited within forty-five (45) days of Seller’s receipt of the audit report, then the amount of Net Sales and Gross Margin as originally reported by Purchaser shall be deemed to have been accepted and agreed to by Seller and shall be binding. Seller shall ensure that Seller’s independent public accountants maintain the confidentiality of Purchaser’s Confidential Information on terms no less restrictive than those set forth in Section 13. Such accountants shall report to Seller only the results of the verification. Except in the event of a bona fide dispute, any underpayment or overpayment of the Purchase Price due to a miscalculation of such amount shall be paid within sixty (60) days after the delivery of the detailed written accountants’ report to Purchaser. To the extent that the results of any audit conducted by Seller discloses an underpayment of the Purchase Price by Purchaser to Seller by an amount equal to or exceeding ten percent (10%) for the period in question, then the costs of the audit shall be borne by Purchaser and Purchaser shall remit such costs within thirty (30) days of the presentment of an invoice.

          3.6.2 Seller shall keep accurate books and records for purposes of documenting the Delivery Price. Said books of account shall be kept at Seller’s principal place of business. Upon at least thirty (30) days prior written notice given on or before June 30th of each calendar year, Purchaser, at its expense, shall have the right to have Purchaser’s independent public accountants (reasonably acceptable to Seller) obtain access to Seller’s financial records for the previous calendar year, during reasonable business hours solely for the purpose of verifying the Delivery Price for such previous calendar year; provided , however , that this right may not be exercised more than once in any calendar year. Seller agrees to reasonably cooperate with Purchaser’s independent public accountants in the conduct of any such audit. Prior to disclosing the results of any such audit, the auditor shall present Seller with a preliminary report of its findings and provide Seller with an opportunity to respond to any questions raised or issues identified; provided, however, that Purchaser shall receive the audit report as originally submitted by independent public accountants along with Seller responses thereto to the extent such responses are given pursuant to questions raised in an audit and to the extent that the responses are material to resolving the audit. Purchase shall solicit or

 


 

receive only information relating to the accuracy of such calculations and shall deliver to Seller a detailed written accountants’ report (setting forth, among other things, the miscalculations, if any, identified by the audit) within thirty (30) days of completion of the audit. If Purchaser does not submit a dispute in regards to Delivery Price so audited within forty-five (45) days of Purchaser’s receipt of the audit report, then the Delivery Price as originally reported by Seller shall be deemed to have been accepted and agreed to by Purchaser and shall be binding. Purchaser shall ensure that Purchaser’s independent public accountants maintain the confidentiality of Seller’s Confidential Information on terms no less restrictive than those set forth in Section 13. Such accountants shall report to Purchaser only the results of the verification. Except in the event of a bona fide dispute, any underpayment or overpayment of the Purchase Price due to a miscalculation of such amount shall be paid within sixty (60) days after the delivery of the detailed written accountants’ report to Seller. To the extent that the results of any audit conducted by Purchaser discloses an overpayment of the Delivery Price by Purchaser to Seller by an amount equal to or exceeding ten percent (10%) for the period in question, then the costs of the audit shall be borne by Seller and Seller shall remit such costs within thirty (30) days of the presentment of an invoice.

SECTION 4

FORECASTS, ORDERS

     4.1 Forecasts and Orders . The initial forecast for the Products will be a 24-month non-binding forecast of demand for each Product after the Effective Date for capacity planning purposes, and is attached as Exhibit D . Purchaser shall submit to Seller a purchase order for the initial six (6) months of the initial forecast within five (5) days of the Start Date of this Agreement. Within five (5) days after the beginning of each calendar quarter during the Term of this Agreement, Purchaser shall provide Seller with a written rolling forecast of Purchaser’s expected requirements for the Products during the following twelve (12) months. The first six (6) months of each such forecast shall be binding; and the amounts set forth for each of the following two (2) calendar quarters shall constitute a non-binding, good faith estimate of the Product requirements of Purchaser for such period for planning purposes only. Seller shall be required to manufacture and deliver to Purchaser such quantities of Products as Purchaser orders in any calendar quarter up to 125% of the quantity forecast for such calendar quarter in the immediately preceding binding forecast. Seller shall use reasonable commercial efforts to manufacture, or have manufactured, and deliver to Purchaser any quantities of Product Purchaser orders in excess of 125% of the quantity forecasted for such calendar quarter, but shall be under no obligation to provide to Purchaser any quantities of Product which exceed 125% of the quantity forecasted for such calendar quarter. If Seller becomes aware of any circumstances that may cause Seller to default on its obligation to deliver such quantities of Product as Purchaser orders or to fail to supply quantities of Product in accordance with Purchaser’s forecasts for any calendar quarter, Seller shall give Purchaser prompt written notice describing such circumstances, together with a proposed course of action to remedy such failure. In the event of a significant change in market conditions, significant new competitive factors and/or new key customer demands, the parties agree to negotiate in good faith on appropriate changes to such forecasts.

     4.2 Orders . Purchaser shall submit binding written or electronic purchase orders for Product (or by any other means agreed to in writing by the parties) to Seller, which shall be placed at least one hundred eighty (180) days prior to the desired date of delivery, and which binding orders shall comply with the binding forecasts set out in Section 4.1. Purchaser shall have no minimum purchase requirements of Products during the Term of this Agreement. Purchase orders shall be submitted by Purchaser to Seller in accordance with previously agreed upon delivery mechanisms.

 


 

     4.3 Conflicts . To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.

     4.4 Capacity Allocation . In the event that Seller’s inability (including without limitation any inability as a result of a Force Majeure Event) to meet firm orders, in whole or in part, is due to a shortage of production capacity or common raw materials, Seller shall promptly notify Purchaser in writing of such shortage of production capacity or common raw materials, and, if possible, the date such shortage of production capacity or common raw materials is expected to end. In such event, Seller shall allocate its available production capacity or raw materials to the production of the Products in such proportion (expressed as a function of equipment utilized) as the production equipment capacity or common raw materials actually utilized to meet orders for the Products over the previous six (6) month period bears to total production equipment capacity which is set up to manufacture the Products in such facility(ies) over that same period.

     4.5 Short Orders; Alternative Sources of Equivalent Products . In the event that Seller fails (for any or no reason including without limitation any Force Majeure Event) to deliver all or any portion of an order of Product to Purchaser in accordance with the terms of this Agreement, Seller shall promptly notify in writing Purchaser of such fact. In addition to any other rights and remedies available to Purchaser, Purchaser shall have the right, but not the obligation, to modify any outstanding purchase order.

SECTION 5

SPECIFICATIONS

     5.1 Specifications .

          5.1.1 Attached as Exhibit A to this Agreement are the Specifications for each of the Products. The Specifications for each Product shall not be changed except as permitted under this Agreement.

          5.1.2 The attached Exhibit A also reflects the current Packaging for each Product. The parties agree to cooperate in good faith with respect to any changes to the Packaging of the Product with the Party requesting any changes to the Packaging bearing the development costs (e.g. artwork or package design) of such changes.

     5.2 Changes .

          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, or materially increase Purchaser’s liability with respect to the Products (any such change hereinafter referred to as a “Material Change”). If such change is a Material Change, Seller shall not be permitted to make such change without the prior written 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 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.

          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 and upon prior written notice to Seller. Seller shall not be required to make any such change but shall consider Purchaser’s request in good faith.

          5.2.4 In order for Purchaser to include in any Product Label or Labeling Purchaser Trademarks or similar changes indicating Purchaser as the distributor of such Product, upon Purchaser’s request, Seller shall provide Purchaser the Label artwork and text in electronic format. Purchaser shall update such artwork and text to include Purchaser Trademarks and such other similar changes as desired by Purchaser to indicate Purchaser as the distributor of such Product; provided that Seller shall not be required to accept such changes if such changes do not comply with the NDA under which the Product is to be sold and distributed and all applicable laws, rules and regulations. Purchaser shall make all necessary arrangements, at its expense, to have such changed Labels or Labeling printed and shall provide to Seller printer’s proofs for Seller’s review and approval. Except with respect to the use of Purchaser’s Trademarks and supplied artwork, Seller shall be responsible for ensuring the accuracy of all information contained on all Labels and Labeling for the Products and for the compliance of all such Labels and Labeling with the NDA under which such Products are to be sold and distributed and applicable law. In accordance with the foregoing, Seller shall, within ten (10) business days of receipt of said printer’s proofs, provide written notice to Purchaser of Seller’s approval of such proofs in the form submitted by Purchaser or with such corrections thereto as included in Seller’s notice.

     5.3 Quality Requirements . The Seller shall, and shall cause any third party manufacturer to, materially comply with the quality requirements set forth on Exhibit E attached hereto (the “Quality Requirements”), with respect to the manufacture of the Product. To the extent that any inconsistencies or conflicts exist between Exhibit E and this Agreement, the stipulations and provisions in this Agreement shall prevail.

     5.4 Trademarks .

          5.4.1 All trademarks, trade names (if needed) and packaging graphics (collectively, the “Purchaser Trademarks”) used by Purchaser in connection with the Products shall be chosen by Purchaser in its discretion. Purchaser shall be responsible for any and all liabilities which may arise from Purchaser’s use of the Purchaser Trademarks. Unless required by applicable law or regulation or unless otherwise agreed to by the parties, Purchaser shall not use a trademark, trade name, or copyright of Seller in connection with the distribution, marketing, promotion or sale of the Products; to the extent that Purchaser believes that it shall or must use a trademark, trade name or copyright of Seller, Seller shall be provided with advance notice of Purchaser’s intention to do so and Seller must consent prior to any such use by Purchaser, such consent not to be unreasonably withheld; provided, however, that Purchaser may use Seller’s trademarks, trade names and copyright as contemplated under Section 14.1 and in Purchaser’s advertising and promotional materials in order to, among other things, identify the Products as comparable to Seller’s brand version product and to identify Seller as

 


 

the owner of Seller’s trademark used with its brand version product (e.g., “Oxandrolone Tablets– Compare to Oxandrin ® . Oxandrin ® is a registered trademark of Savient Pharmaceuticals, Inc.”). For the purpose of clarity, any use of Seller’s trademarks, trade names and/or copyright pursuant hereto shall be made only with the prior written approval of Seller as to the specific use thereby contemplated.

          5.4.2 Use of Purchaser Trademarks by Seller shall be solely for the purpose of preparing and Packaging the Products for sale to Purchaser. Purchaser hereby grants a limited license on a non-exclusive basis to Seller hereunder to use the Purchaser Trademarks in accordance with the terms of this Agreement. Any and all Products supplied hereunder are for sale only to Purchaser for distribution by Purchaser. Seller will not, at any time in any manner, represent that it has ownership in any Purchaser Trademarks and acknowledges that it has no ownership interest in any Purchaser Trademarks nor will Seller grant a sublicense to any third party to use such Purchaser Trademarks. Upon expiration or earlier termination of this Agreement, Seller will cease and desist use of any Purchaser Trademark in any way.

     5.5 Certificate of Analysis; Certificate of Compliance . Each shipment of the Products to Purchaser shall be accompanied by a certificate of analysis prepared by an authorized representative of Seller, including where applicable a third party manufacturer, confirming that the Products in the shipment have been tested and shown to be in accordance with the Specifications for such Products. Such certificates of analysis and certificates of compliance shall be substantially in the form set forth in the Quality Requirements.

     5.6 Expiry Dating . Except for Products which comprise the Existing Inventory which are addressed in Section 2.2.4, all Products shipped to Purchaser, at the time of shipment by Seller, shall have no less than [ ** ] months expiry dating remaining for the 2.5mg Product and no less than [ ** ] months expiry dating remaining for the 10mg Product. Purchaser shall notify Seller in the event a Product has [ ** ] months or less dating remaining, and within thirty (30) days of receipt of such notice Purchaser shall deduct from the next quarterly payment owing to Seller [**] percent ([**]%) of the amount actually paid to Seller for such Product. For all deliveries consisting of Existing Inventory, at the time of shipment by Seller, such Products shall have no less than [ ** ] months expiry dating remaining. At Seller’s option and sole expense, Purchaser shall (a) destroy such Product, or (b) return such Product to Seller.

     5.7 Stability Testing . Seller shall maintain a stability testing program for the Products and provide Purchaser with an annual product report thereon. In the event that any results from such program could indicate that Product would not meet its expiry date, Seller shall promptly notify Purchaser. At least one (1) batch per year of each Product (or its branded equivalent), or as otherwise required by the NDA, shall be included in the stability program.

     5.8 Annual Report . Purchaser will supply distribution information and other required information to Seller for the purposes of inclusion into the Annual Report to FDA and shall provide such information in a timely manner so as to enable Seller to file the Annual Report in accordance with applicable regulations. To the extent that Seller requests additional information from Purchaser, Purchaser agrees to reasonably cooperate with Seller.

 


 

SECTION 6

TERM

     6.1 Term . The term of this Agreement shall commence on the Effective Date and remain in effect for each Product hereunder for a period of ten (10) years from the Start Date for such Product (the “Initial Term”), unless sooner terminated as expressly provided under the terms of this Agreement. This Agreement will automatically renew for successive two-year periods following the Initial Term (each, a “Renewal Term”), unless terminated prior to the expiry of the Initial Term or any Renewal Term by either Party confirmed in writing and delivered at least twelve (12) months prior to the expiration of the Initial Term or the Renewal Term to which it relates (the Initial Term, together with any Renewal Terms, the “Term”). The distribution term for Product shall become effective as of the date upon which Seller supplies and Purchaser actually receives the Launch Quantities of Product (the “Distribution Term”) and shall remain in effect until the end of the Term unless sooner terminated as expressly provided under the terms of this Agreement.

SECTION 7

TERMINATION

     7.1 Termination for Convenience . Each of Seller or Purchaser may terminate this Agreement in its sole discretion (and without any liability to the other for such termination), with respect to any Product, at any time on or after the fourth (4th) anniversary of the Start Date of such Product upon no less than one (1) year prior written notice to the other, which prior written notice, if any, shall be delivered on or after such fourth (4th) anniversary of such Start Date.

     7.2 Breach . This Agreement may be terminated, on a Product by Product basis, prior to the expiration of the Term, by either Party by giving written notice of its intent to terminate and stating the grounds therefor if the other Party shall materially breach or materially fail in the observance or performance of any representation, warranty, guarantee, covenant or obligation under this Agreement. The Party receiving the default notice shall have sixty (60) days from the date of receipt thereof to cure the breach or failure. If a breach is not curable within such sixty (60) day period (other than a failure to supply Product in accordance with the terms of this Agreement), then the non-performing Party shall have an additional sixty (60) days within which to cure such breach so long as the non-performing Party is diligently working towards a remedy for such breach. In the event such breach or failure is cured in accordance with the provisions of this Section 7.2, the default notice shall be of no effect. In the event such breach or failure is not cured in accordance with the provisions of this Section 7.2, then this Agreement shall terminate without the requirement of the non-defaulting Party providing any additional notice to the defaulting Party.

     7.3 Insolvency, Etc . This Agreement may be terminated, prior to the expiration of the Term, upon written notice by either Party: (i) in the event that the other Party hereto shall (1) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator of itself or of all or a substantial part of its property, (2) make a general assignment for the benefit of its creditors, (3) commence a vol


 
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