definiens: means, with respect to Licensed Product in bulk form manufactured for use as an activepharmaceutical ingredient or in finished final packaged and labeled product form, or in intermediate states, as the case may be, Manufactured by or on behalf of a Party under this Agreement, the reasonable internal and external costs of such Party or anyof its Affiliates incurred in Manufacturing such Licensed Product, including : ( a ) to the extent that such Licensed Product isManufactured by such Party or any of its Affiliates, the cost of goods sold of such Licensed Product, consisting of directmaterials and direct labor 4costs, plus Manufacturing overhead directly attributable to Licensed Product supplied ( excluding facilities start - up costs, corporate administrative overhead, depreciation and costs associated with excess capacity ), all calculated in accordance withGAAP in the United States consistently applied, ( b ) to the extent that such Licensed Product is Manufactured by a Third Partymanufacturer, the actual fees paid by such Party or any of its Affiliates to the Third Party for the Manufacture, supply, testing, packaging, labeling and shipping of such Licensed Product, and any reasonable out - of - pocket and direct labor costs actuallyincurred by such Party or any of its Affiliates in managing or overseeing the Third Party relationship, and ( c ) royalties, licenseor other fees paid by such Party or any of its Affiliates to Third Parties in respect of Manufacture of such Licensed Product