definiens: means costs of manufacturing an mRNAConstruct or Product or any component thereof, including the formulation of Product, which iseither:(a)supplied to a Party by a Third Party, in which eventManufacturing Costs means : ( i ) the amount paid to such Third Party for the manufacturing andsupply of 9CO - DEVELOPMENT AND CO - COMMERCIALIZATION AGREEMENTbetween CUREVAC and ARCTURUSConfidential Execution Copy mRNA Construct or Product ( excluding any payments to Third Parties for licenses to intellectualproperty ) ; plus ( ii ) reasonable direct and identifiable internal costs and Third Party costs incurredor accrued ( including any prepayments ) by the manufacturing Party in connection with inventorywrite - offs, variances, manufacturing process improvements, storage, freight, manufacturing scale - up, manufacturing site qualification, materials, quality assurance and quality control ( includingtesting ), supply chain management, capital equipment, similar activities composing themanufacturing Party ’s oversight of the manufacturing process of the Third Party, and any value - added tax or similar tax due for amounts paid to such Third Party, but excluding costs otherwiseincluded within Clinical Development Costs ; or(b)manufactured directly by a Party or its Affiliate, in whichcase Manufacturing Costs means the per unit ( which for purposes of ongoing costaccounting purposes shall be calculated in accordance with the Manufacturing Party ’s then - current standard cost process in accordance with GAAP that is applied consistently to allpharmaceutical products manufactured by such Party in the applicable facility )