definiens: means, with respect to a Product, the costs incurred by a Party or its Affiliateor ( Sub)licensee in connection with Manufacturing or purchasing from a Third Party, as applicable, each Product thatis either ( a ) supplied by a Third Party, or ( b ) manufactured directly by a Party or an Affiliate or ( Sub)licensee of suchParty, determined as follows and in accordance with Accounting Standards : In the case of clause ( a ) above, Manufacturing Costs means ( i ) those amounts that are paid to a Third Party by aParty in connection with the Manufacture of the Product, including for process improvements, storage, manufacturingscale - up, manufacturing site qualification, QA and QC ( including testing ), capital equipment depreciation, customsduties or excise taxes, plus ( ii ) the relevant Party ’s reasonable FTE Costs and direct out - of - pocket costs recorded asan expense by * Confidential Information, indicated by [ * * * ], has been omitted from this filing and filed separately with the Securitiesand Exchange Commission 12Confidential Execution Version such Party in connection with the Manufacture, including supply chain management, of the Product, but excluding anygeneral and administrative costs . To the extent any non - refundable or non - creditable value added or similar tax is duewith respect to amounts paid to such Third Party for Manufacture of any portion of a Product, such amounts shall beconsidered Manufacturing Costs under this clause ( a )