Contingent Supply of Cephalon Supplied Product Sample Clauses

Contingent Supply of Cephalon Supplied Product. In the event that Xxxx is unable to obtain, on or before 30 days prior to the earliest of: (i) September 5, 2006, if Cephalon is either not granted Pediatric Exclusivity with respect to ACTIQ or Cephalon did not obtain Final FDA approval of ACTIQ NDA or ACTIQ SF NDA, as the case may be, for the marketing of ACTIQ SF, as set forth in Section 2.3 of this Agreement; (ii) February 3, 2007, if Cephalon is granted Pediatric Exclusivity with respect to ACTIQ; or (iii) the Anticipated Final FDA Approval of OVF (such earliest date being the “First Delivery Date”), FDA ANDA Approval necessary to permit the manufacture and sale of Xxxx Generic Product or Xxxx Generic SF Product, as the case may be, and subject to the terms and conditions set forth in this Article 6, then Cephalon will manufacture and supply to Xxxx for resale in the United States Cephalon Supplied Product commencing on the First Delivery Date; provided, however, that Cephalon shall not be required to supply Cephalon Supplied Product in a Substantially Sugar-free formulation more than 30 days prior to the ACTIQ SF Patent Rights License Effective Date. Xxxx shall have the option to have Cephalon manufacture and supply to Xxxx a Cephalon Supplied Product that is either Substantially Sugar-free or not Substantially Sugar-free; provided, however, that if Cephalon is simultaneously selling both ACTIQ and ACTIQ SF in the United States, Xxxx shall have the option to have Cephalon manufacture and supply both Substantially Sugar-free and not Substantially Sugar-free formulations of Cephalon Supplied Product. Cephalon will supply such Cephalon Supplied Products in finished dosage form in bulk containers ready for packaging and labeling by Xxxx, irrespective of Cephalon’s continued manufacture or production of ACTIQ or ACTIQ SF for its own purposes. For purposes of clarification, Xxxx’x receipt at any time during the term of the supply provisions of this Agreement of Cephalon Supplied Product that is not Substantially Sugar-free shall not otherwise terminate Cephalon’s obligations to supply to Xxxx a Substantially Sugar-free formulation of Cephalon Supplied Product under the terms and conditions of this Article 6. In the event that Xxxx has obtained FDA ANDA Approval necessary to permit the manufacture and sale of Xxxx Generic Product, but FDA withdraws such FDA ANDA Approval prior to Xxxx’x Commercial Launch of the Xxxx Generic Product, Cephalon will manufacture and supply to Xxxx for resale in the United State...
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Related to Contingent Supply of Cephalon Supplied Product

  • Product Supply 5.2.1 HEMISPHERX undertakes and agrees to supply to IMPATIENTS on an exclusive basis, IMPATIENTS’ requirements of Product ordered in accordance with the terms of this Agreement, for distribution and sale in the Territory, limited to EAP use of Product in accordance with Early Access Approvals.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Product Warranty; Product Liability (a) Except as set forth on Company Disclosure Schedule 4.23, the products produced, sold or delivered by the Company in conducting the Business have been in all material respects in conformity with all product specifications and all applicable Laws. To the Company’s Knowledge, the Company has no material Liability for damages in connection therewith or any other customer or product obligations not reserved against on the Balance Sheet.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Product The term “

  • Defective Products None of the Group Companies has manufactured, sold or supplied products which are, or were, in any material respect, faulty or defective, or which do not comply in any material respect with any representations or warranties expressly made by such Group Company, or with all applicable regulations, standards and requirements.

  • Supply Price In event BTC exercises the Supply Option, the Supply Agreement shall afford Auxilium supply terms for Year 1 that are not less favorable than the average price afforded to Auxilium by the Back-Up Suppliers for the year immediately preceding the Supply Date and supply terms for each successive year that are not less favorable than the average price afforded to Auxilium by the Back-Up Suppliers for each preceding year as applicable.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Additional Products Throughout the Term, Rockwell shall provide to DaVita and the DaVita Facilities the right to purchase and/or lease all current or new products manufactured, utilized, licensed, sold or distributed by Rockwell or any of its Affiliates (including products and product lines acquired by Rockwell or any of its Affiliates as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates) that are or that become Commercially Available and which are not already covered by this Agreement or by any other agreement, whether written or oral, between the parties hereto (such products are collectively referred to as “Additional Products” and individually as an “Additional Product”). Rockwell agrees to include DaVita in all of its and its Affiliates distributions of customer announcements regarding Rockwell’s or its Affiliates’ Additional Products. The purchase price for any such Additional Products shall be negotiated by the parties hereto in good faith and the agreed upon purchase price shall be memorialized in writing as a supplement or amendment to this Agreement. Rockwell covenants and agrees that it shall only make an offer for the sale of any Additional Product(s) to DaVita’s Vice-President of Clinical Operations, Chief Medical Officer, or Vice-President of Purchasing, and not to any DaVita Facility directly; provided that the purchase of any Additional Product by DaVita or any DaVita Facility through a Rockwell product catalog made generally available to the dialysis community shall not be a breach by Rockwell of this Section 8.1. If Rockwell or any of its Affiliates acquires any Additional Product(s) as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates with a Person with which DaVita or a DaVita Facility, as applicable, already has a purchase or rebate arrangement whether written or oral (a “Prior Agreement”), Rockwell or such Affiliate covenants and agrees that it shall continue to abide by all of the terms and conditions of such Prior Agreement or if DaVita requests, such Additional Product(s) shall be included in this Agreement on terms to be negotiated and determined by the parties hereto as provided in this Section 8.1.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

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