Engineering Batches Required Clause Samples

Engineering Batches Required. If the Services include the manufacture of one or more CGMP Batches, Cytovance requires the manufacture of an Engineering Batch prior to the manufacture of the first CGMP Batch at each scale of Client Product (unless the Parties agree in the SOW that no Engineering Batch is necessary). The purpose of the Engineering Batch is to familiarize Cytovance with the intended CGMP Manufacturing Process, observe the Client Technology, Client Components, Client Equipment, and Raw Materials, and reveal whether the intended Master Batch Records, CGMP Manufacturing Process, or Specifications require modifications or changes.