definiens: means the per unit of Product, including variances to standard costs, yieldlosses, and inventory write - offs . This standard cost shall include the cost of materials, labor, and other direct and identifiablevariable costs incurred or accrued by the manufacturing Party in connection with the Manufacture of a Product, manufacturingprocess improvements, storage, freight, manufacturing scale - up, manufacturing site qualification, quality assurance andquality control ( including testing ), supply chain management, costs of equipment, plant operations and plant support servicesnecessary to produce a Product, and costs deemed to be Standard Unit Costs pursuant to Section 7.2(d ) . These costs of plantoperations and support services shall include utilities, maintenance, engineering, safety, human resources, finance, plantmanagement and other similar activities, including idle plant capacity reserved specifically for the Product based onanticipated Product volumes in the ensuing [ * ] . Costs that can not be identified to a specific activity supporting 20 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separatelywith the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended . Manufacturing of a Product, such as charges for overhead or excess capacity not specifically reserved for the Product asdescribed above, shall be excluded from the determination of Manufacturing Costs