definiens: means . if manufactured by [COMPANY] or its Affiliates, with respect to the Product, the fully - burdened cost of manufacturing, assembling, filling and packaging of the Product expressed on a per unit manufactured basis, including the cost of ( i ) material, excipients, packaging and labeling material, and ( ii ) direct labor of [COMPANY] employees or its Affiliates ' employees ( including basic wages, labor and related payroll taxes and benefits ) incUlTed or spent in the actual production, filling, packaging and labeling of the Product, including without limitation for quality assurance, purchasing and manufacturing facility operations, and ( iii ) overhead of [COMPANY] and its Affiliates ( including operating expenses, indirect labor and related payroll taxes and benefits, depreciation, taxes, insurance, rent, repairs and maintenance, supplies ) incurred or spent in support of the actual production, filling, packaging and labeling of the Product, but not for any cost of any unused manufacturing capacities that [COMPANY] may have in excess of the requirements contained in the forecasts provided by the Company, and ( iv ) transportation, storage, nonnreimbursable import or export taxes of or for the Product or any part thereof as incurred or spent by [COMPANY] or its Affiliates in connection with the supply of the Product pursuant to the terms of a supply agreement, and ( v ) and third party sub­contract manufacturer as invoiced to [COMPANY], provided, that, any such third party invoices shall be based on the same cost components of the sub - contractor as described in ( i ) through ( iv ) hereof plus a 10 % margin, all as detennined in accordance with generally accepted accounting principles consistently applied