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. 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. 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. 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. 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. 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 ***Confidential Treatment Requested
Validation Batches. Prior to beginning Manufacturing of Bulk Intermediate and Bulk Drug, DSM will Manufacture and Release validation Batches sufficient to validate Manufacturing at the Facilities (the “Validation Batches”). It is intended by the Parties that the Validation Batches will result in [***] metric tons (“MT”) of Ca Bulk Drug from the Manufacture of [***] Batches. The Parties agree that the goal of the Campaign to produce Validation Batches is to qualify Manufacturing at the Facilities for future Manufacture of Bulk Intermediate and Bulk Drug, irrespective of the actual final volume; provided however that [***] Batches will be Manufactured ([***] Batch), with [***] Validation Batches Manufactured consecutively, to yield a minimum of [***] MT (on a [***]) of Bulk Drug to be delivered to RELYPSA or RELYPSA’s designated recipient. The Validation Batches shall be Manufactured in accordance with all of the requirements of this Agreement and the Quality Agreement. Appendix 1 sets forth the specific approach to be used in Manufacturing the Validation Batches.
Validation Batches. Patheon shall manufacture validation batches of Product for Avanir as described and agreed to by the parties in a work order substantially in the form attached hereto as Schedule L, which shall include the fees payable by Avanir for such services. Avanir agrees that provided Patheon has manufactured the validation batches in accordance with the Specifications, cGMPs and Applicable Laws, (i) Avanir shall have no right to reject any Product from a validation batch under Section 6.1, and (ii) Avanir shall assume all risk, liability and responsibility for such Product, including, without limitation, financial and regulatory liability, and full responsibility for any recall thereof. *** Certain confidential portions of this Exhibit were omitted by means of blackout of the text (the “Mxxx”). This Exhibit has been filed separately with the Secretary of the Commission without the Mxxx pursuant to the Company’s Application Requesting Confidential Treatment under Rule 24b-2 under the 1934 Act.
Validation Batches. Supplier shall invoice Lannett for the cost of validation batches that will be used for Commercial Launch and Lannett shall pay such invoice within sixty (60) days of receipt of such invoice. The provisions of Section 5.4 concerning the shelf-life shall not apply to the delivery of validation batches but in no event shall the remaining shelf-life of the validation batches be less than thirteen (13) months at the time of Lannett’s receipt of the validation batches
