definiens: . Cost of Goods Sold means, with respect to API Bulk Drug Substance, Finished Product or placebo, as the case may be, Manufactured under this Agreement, the reasonable internal andexternal costs of a Party or any of its Related Parties incurred in Manufacturing such API Bulk Drug Substance, Finished Product or placebo, including : ( a ) to the extent that such API Bulk Drug Substance, Finished Product orplacebo is Manufactured by a Party or any of its Related Parties, the Cost of Goods Sold of such API Bulk DrugSubstance, Finished Product or placebo, consisting of direct material and direct labor costs, [ * * ] all determined inaccordance with the books and records of the applicable Party or its Related Party(ies ) maintained in accordance withUnited States GAAP, consistently applied, and ( b ) to the extent that such API Bulk Drug Substance, FinishedProduct or placebo is Manufactured by a Third Party manufacturer, the actual fees paid by a Party or any of itsRelated Parties to the Third Party for the Manufacture, supply, packaging and labeling of such API Bulk DrugSubstance, Finished Product or placebo [ * * ], determined in accordance with the books and records of the applicableParty or its Related Party(ies ) maintained in accordance with United States GAAP, consistently applied . Cost ofGoods Sold shall not include [ * * ], except with respect to Licensed Product Manufactured by [COMPANY] for [COMPANY] tosupply to its Asian Partner