Common use of Validation Batches Clause in Contracts

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. Supplier agrees 8.1.1 Based on purchase orders submitted by Alpharma to perform Tris at least **** days prior to the Product validation procedures set forth requested delivery date, Tris shall manufacture Validation Batches in [ * ], such procedures to be mutually agreed to in writing a quantity as requested 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 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 Purchase Order and this Agreement, Batches in shorter periods of time to allow Alpharma to optimize 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 dating of the Product that meet the Product Specifications, at which time in such consecutive batches shall be considered “Validation BatchesBatches after launch.” 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 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 Purchase Order. Supplier acknowledges and agrees that Batches, the Validation Batches mayDevelopment Committee shall determine under Section 3.2.1(g), upon Purchaser’s receipt of written FDA approval of the Product, be sold as commercial Product subject pursuant to the warrantiesprocess set forth in Section 3.1, indemnification provisions the optimal batch size for Product. Thereafter, Alpharma's forecasts and the other terms orders pursuant to Sections 8.3 and 8.4 shall be in multiples of this Agreementsuch batch size.