Common use of Validation Batches Clause in Contracts

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.