Validation Batches Sample Clauses

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. 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. 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 will apply to any Product after release by Patheon.

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. 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. 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. Supplier agrees to perform the Product validation procedures set forth in [ * ], such procedures to be mutually agreed to in writing by the Parties (the “Validation Purchase Order”). Upon execution, the Validation Purchase Order shall be attached hereto as Exhibit C-3. If there is a conflict between the terms of the Validation Purchase Order and this Agreement, the terms of this Agreement shall control. Each batch of Product manufactured pursuant to the Validation Purchase Order shall be considered an “Experimental Batch” until Supplier has manufactured [ * ] batches of the Product that meet the Product Specifications, at which time such consecutive batches shall be considered “Validation Batches.” If any Experimental Batch fails to meet the Product Specifications (“batch failure”) due to Supplier’s gross negligence, the failure of Supplier’s equipment or Supplier’s failure to adhere to the batch records, validation protocols or other similar documentation, Supplier shall at its own expense (excluding the costs of API which shall be borne by Purchaser), manufacture additional Experimental Batches until the successful completion of a total of [ * ] batches of the Product meet the Product Specifications. Supplier shall not be responsible for any batch failure directly caused by the Product formulation as provided by Purchaser, the failure of equipment provided by Purchaser or testing methods developed by Purchaser or provided by Purchaser (“Purchaser Failures”). If Purchaser requests that Supplier manufacture additional batches of Product attributable to such Purchaser Failures, such additional batches shall be at Purchaser’s expense. The Parties shall cooperate in good faith to resolve any problems causing a batch to fail to meet the Product Specifications. Purchaser shall pay to Supplier the price per batch of Product for the Validations Batches as set forth in the Validation Purchase Order. Supplier acknowledges and agrees that the Validation Batches may, upon Purchaser’s receipt of written FDA approval of the Product, be sold as commercial Product subject to the warranties, indemnification provisions and the other terms of this Agreement.

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”), specifically the Master Agreement for Pharmaceutical Development and Technology Transfer Services between the Parties, effective May 23, 2018, 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. 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 “M▇▇▇”). This Exhibit has been filed separately with the Secretary of the Commission without the M▇▇▇ pursuant to the Company’s Application Requesting Confidential Treatment under Rule 24b-2 under the 1934 Act.