Validation Batches. Where Product is manufactured by Patheon (or any of its Affiliates) under a separate pharmaceutical development or technology transfer agreement (the “Development Agreement”) and then released by Patheon for commercial sale or distribution by Client, the performance of the applicable pharmaceutical development or technology transfer services including the manufacture of the Product will be governed by the terms of the Development Agreement and will not be subject to the terms and conditions of this Agreement. The terms of this Agreement and the applicable Product Agreement will apply to any Product after release by Patheon.
Validation Batches. Each batch of Product manufactured as part of the Validation Activities will be considered to be an "Experimental Batch" until BLP has manufactured [*] that meets the Specifications applicable to such Product upon which such consecutive batches shall be considered "Validation Batches." ISTA shall pay to BLP the Product price set forth in Appendix A for each Experimental Batch manufactured as part of the Validation Activities; provided that if any such Experimental Batch does not meet the Specifications due to BLP's negligence, the failure of BLP's Processing equipment, or BLP's failure to adhere to the batch records, validation protocols or other similar documentation, BLP shall, at its own expense, manufacture additional Experimental Batches of Product until the successful completion of a total of [*] which meet the Specifications. BLP shall not be responsible for any batch failures directly caused by Product formulation, container compatibility and testing methods developed or provided by ISTA to BLP hereunder. ISTA may, at its own expense, request BLP to manufacture additional batches of Product attributed to such failures. BLP and ISTA shall cooperate in good faith to resolve any problems causing any out-of-Specification batch. It is understood and agreed that the Validation Batches will, upon ISTA's receipt of written FDA approval of the Product, be sold as commercial Product.
Validation Batches. The three (3) planned validation batches shall be manufactured under current Good Manufacturing Practices, sanofi-aventis US or its designated Affiliate local site requirements and all applicable laws rules and regulations. Horizon shall provide sanofi-aventis US or its designated Affiliate, without any cost or expense to sanofi-aventis US or such Affiliate, all required Horizon Materials and shall pay the price set forth in Section 4.2 for such validation batches. The batch size used to manufacture such validation batch shall be determined in good faith by the Parties. Sanofi-aventis US or its designated Affiliate shall provide a written report for the manufacturing of the validation batches to support Horizon’s preparation of the regulatory dossiers. Following approval of the NDA each Party understands and agrees that some of the Product manufactured in the validation activities and meeting all release specifications may be packaged and distributed for patient use as pharmaceutical samples. However, for any validation material deemed not saleable due to dating or hold time constraints, Horizon shall pay the price set forth in section 4.2.
Validation Batches. In addition to complying with any other requirements or specifications hereunder, any validation batches of the Product produced at the Additional Manufacturing Facility and/or Supplemental North American Manufacturing Facility shall be finished and delivered to RELIANT in saleable condition for sale to the trade or as samples, as shall be directed by RELIANT. RELIANT shall pay for such validation batches in accordance with Section 8.1(a).
Validation Batches. Prior to commencement of manufacture of Validation Batches as described below in this Section 3.5, the parties shall mutually agree in good faith on
Validation Batches. At Orphan’s option and request, after execution of the Supply Agreement, Orphan may purchase validation batches of Product prepared in connection with the Services, pursuant to the terms and conditions of the Supply Agreement (including without limitation the terms and conditions governing price, payment, warranty, indemnification and limitation of liability). Catalytica shall retain representative samples from each batch of the Products for record keeping, testing and regulatory purposes.
Validation Batches. For the validation campaign of the Products, Syntagon will produce in 2013 of three (3) Batches of XMeNa and three (3) Batches of 13cis XMeNa of 1100 g (+/-20%), and before the validation campaign, one (1) of each Technical Batch to enable the Process to be validated at this scale. Syntagon will complete the validation campaign and Oasmia will buy Technical and Validation Batches in accordance with the price conditions set forth in Section 9. Syntagon will deliver analysis results and CoA on each of the Validation Batches according to Oasmia requirements and issue a complete validation report to Oasmia within four (4) weeks after the end of the validation campaign.
Validation Batches. 8.1.1 Based on purchase orders submitted by Alpharma to Tris at least **** days prior to the requested delivery date, Tris shall manufacture Validation Batches in a quantity as requested by Alpharma for each of the Initial Product and Subsequent Product, provided that Tris shall cooperate with Alpharma and use Commercially Reasonable Efforts to make such Validation Batches in shorter periods of time to allow Alpharma to optimize the dating of the Product in such Validation Batches after launch.
8.1.2 Except as set forth in Section 8.1.3, Alpharma shall not make any payments to Tris for Validation Batches of the Product produced hereunder.
8.1.3 In the event any such Validation Batches meet the Specifications, regardless of whether such Validation batches can be used and sold by Alpharma for commercial purposes, Alpharma shall be responsible for paying Tris its aggregate cost of goods, calculated on a Fully-Burdened Manufacturing Cost basis (the "Basic Transfer Price") plus (i) ****% if such Validation Batches are sold by Alpharma as set forth in Section 8.4.2, plus royalties on the sale of such Validation Batch(es) in accordance with Section 6.1, 6.3 and 6.4, or (ii) ****% if such Validation Batches are not sold by Alpharma. In the event any such Validation Batches do not meet the Specifications, Tris shall be responsible for the costs of appropriately destroying such Validation Batches. The Basic Transfer Price shall also be used to price commercial supply of the Product as set out below.
8.1.4 During the process of manufacturing the Validation Batches, the Development Committee shall determine under Section 3.2.1(g), pursuant to the process set forth in Section 3.1, the optimal batch size for Product. Thereafter, Alpharma's forecasts and orders pursuant to Sections 8.3 and 8.4 shall be in multiples of such batch size.
Validation Batches. Following the completion of the Facility Investments and prior to the commencement of Manufacturing for Product Launch, LANXESS will Manufacture and Release a quantity of Bulk Intermediate and Bulk Drug as specified by RELYPSA to validate Manufacturing at the Facility (the “Validation Batches”). The Validation Batches shall be Manufactured in accordance with all of the requirements of this Agreement.
Validation Batches. Seller is responsible for generating a validation package that includes: (1) the validation protocol, (2) full batch document packages, (3) all validation data and (4) validation report for all Validation batches of the Products manufactured. In the event of a “For Cause Incident,” following prior written request, Purchaser shall have the right to review the protocols and reports at Seller’s premises during business hours.
