definiens: means costs of manufacturing an mRNA Construct or Product or any component thereof, including the formulation of Product, which is either : ( a)supplied to a Party by a Third Party, in which event Manufacturing Costs means : ( i ) the amount paid to such Third Party for the manufacturing and supply of 9 CO - DEVELOPMENT AND CO -COMMERCIALIZATION AGREEMENT between CUREVAC and ARCTURUS Confidential Execution Copy mRNA Construct or Product ( excluding any payments to Third Parties for licenses to intellectual property ) ; plus ( ii ) reasonable direct and identifiable internal costs and Third Party costs incurred or accrued ( including any prepayments ) by the manufacturin g Party in connection with inventory write -offs, variances, manufacturing process improvements, storage, freight, manufacturing scale -up, manufacturing site qualification, materials, quality assurance and quality control ( including testing ), supply chain m anagement, capital equipment, similar activities composing the manufacturing 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 otherwise i ncluded within Clinical Development Costs ; or ( b)manufactured directly by a Party or its Affiliate, in which case Manufacturing Costs means the per unit ( which for purposes of ongoing cost accounting purposes shall be calculated in accorda nce with the Manufacturing Party ’s then -current standard cost process in accordance with GAAP that is applied consistently to all pharmaceutical products manufactured by such Party in the applicable facility )