definiens: means, with respect to any Compound or Product, the fullyburdened cost and expense to manufacture or supply such Compound or Product, which means:(a ) in the case of products and services acquired from Third Parties, including quality control andquality assurance services, payments made to such Third Parties ; and ( b ) in the case ofmanufacturing services performed by a Party or its Affiliates, including manufacturing services tosupport products and services acquired from Third Parties as contemplated in subsection ( a ), theactual unit costs of manufacture, plus the variances and other costs specifically provided forherein . Actual unit costs shall consist of [ … * * * … ], all calculated in accordance with GAAP . Directmaterial costs shall include the costs incurred in [ … * * * … ] . Direct***Confidential Treatment Requested 3labor costs shall include the cost of : ( i ) [ … * * * … ] ; ( ii ) [ … * * * … ] ; and ( iii ) [ … * * * … ]