definiens: means, with respect to any Compound or Product, the cost to manufacture DrugSubstance, Bulk Drug Product or finished Product for clinical use, as applicable, which means : ( a ) in the case ofproducts and services acquired from Third Parties, payments made to such Third Parties ; and ( b ) in the case ofmanufacturing services performed by a Party or its Affiliates, including manufacturing services that are reasonablynecessary to support products and services acquired from Third Parties as contemplated in subsection ( a ), the actualunit costs of manufacture, plus the variances and other costs specifically provided for herein . Actual unit costs shallconsist of direct material costs, direct labor costs, and manufacturing overhead directly attributable to such DrugSubstance, Bulk Drug Product or finished Product, all calculated in accordance with U.S. generally acceptedaccounting principles . Direct material costs shall include the costs incurred in purchasing materials, including salesand excise taxes imposed thereon, customs duties and charges levied by government authorities, and all costs ofpackaging components . Direct labor costs shall include the cost of : ( i ) employees working in manufacturing andpackaging of such Drug Substance, Bulk Drug Product or finished Product and engaged in direct manufacturingactivities ; and ( ii ) direct or indirect quality control and quality assurance activities . Manufacturing overhead attributableto such Drug Substance, Bulk Drug Product or finished Product shall include a reasonable allocation of indirect laborcosts ( not previously included in direct labor costs ) and a reasonable allocation of facilities and other overhead costs