Bulk Compound Supply Sample Clauses

Bulk Compound Supply. Pursuant to the Development Agreement, ILEX has --------------------- contracted for and anticipates receiving, within sixty (60) days after the Effective Date, approximately 200kgs of cGMP bulk active Compound ("Bulk Active Order") suitable for clinical use, upon formulation into finished drug product. Paralex, on its part, agrees to purchase its requirements of bulk active Compound from ILEX, provided that the quality of the Bulk Active Order of Compound meets the specifications set forth in the Development Agreement, until such time as the Bulk Active Order under the Development Agreement is fully consumed at (a) ILEX's actual cost therefor (estimated to be about $800,000), if purchased immediately after its receipt by ILEX or (b) ILEX's actual cost plus 50%, if taken on a piecemeal, or as needed basis, Provided further that Paralex shall be obligated to purchase the entire 200 kg LICENSE AND OPTION AGREEMENT 12/20/2001 bulk active Compound order from ILEX within the three (3) year period after the Effective Date. The bulk active Compound shall be shipped pursuant to Paralex's instructions to locations designated by Paralex and ILEX shall warrant that the bulk active Compound, at time of shipment, will meet specifications established in the Development Agreement, with Paralex's sole remedy being refund of any payment made for bulk active Compound failing the specifications. In the event of a dispute arises as to whether the bulk active Compound failed specifications, a sample shall be transferred to an independent testing laboratory, mutually acceptable to ILEX and Paralex for reanalysis, with the results of the independent; testing laboratory being binding on the parties and the party found to be in error paying for the reanalysis, After ILEX's receipt of the contracted 200kg supply of bulk active Compound under the Development Agreement, ILEX will promptly take all steps necessary to assign to Paralex all of ILEX's interest in and rights under the Development Agreement and Paralex shall accept such assignment, including all rights and any continuing obligations of ILEX set forth therein. Notwithstanding such assignment, ILEX shall be responsible for the performance of all of its obligations under the Development Agreement, including without limitation the payment of all amounts due to Catalytica in respect of the entire bulk Compound order, through the effective date of such assignment. From the Effective Date until Paralex has purchased the entire Co...
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Related to Bulk Compound Supply

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Product The term “

  • Clinical Supply Takeda will provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan (estimated by Licensee as of the Effective Date to be [***]), solely to the extent that Takeda can supply such TAK-385 [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Licensed Compound or TAK-385 Licensed Products (a) from its supply of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as of the Effective Date and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide to Licensee, at [***] any additional supplies of TAK-385 Licensed Compound or TAK-385 Licensed Products in excess of the Initial Clinical Supply needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan. Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery. The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties). As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***]. If the Parties have not entered into a definitive agreement within such negotiation period, then the final terms and conditions of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree).

  • Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Commercialization Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

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