definiens: or means, with respect to the Product and [ * * * ] of [COMPANY] or its Affiliates hereunder, [ * * * ] % ) of ( 1 ) [COMPANY] ’ cost to Manufacture, if Manufa ctured by [COMPANY] or its Affiliates or ( 2 ) the actual Third Party costs of such Manufacturing incurred by [COMPANY] or its Affiliates, if Manufactured by a Third Party, in each case ( ( 1 ) and ( 2 ) ) as determi ned for each stage of the manufacturing process, including [ * * * ] ( except, in the case of ( 1 ), to the extent attribu table to [COMPANY] ’ or any of its Affiliates ’ negligence o r willful misconduct, or in the case of ( 2 ), to the extent [COMPANY] or any of its Affiliates receive a refu nd, credit or other recovery from such Third Party ), all in accordance with GAAP . Such Fully Burdened Manufactu ring Cost shall include the following incurred by o r on behalf of [COMPANY] or its Affiliates and reasona bly allocated to the Product and [ * * * ] : ( a ) FTE Costs and costs of consultants, contract ors or other personnel performing Manufacturing or supply activities ; ( b ) direct materials costs ( including costs of v ials, labeling and packaging ) ; ( c ) raw materials and reagents costs specificall y for actual manufacturing of goods and raw material warehouse costs ; ( d ) operating costs of facilities and equipment ( including start up and cleaning costs of production ), excluding any surplus or idle capacity costs ; ( e ) a charge for depreciation, repairs and maint enance costs of facilities and equipment, excluding any surplus or idle capacity costs ; ( f ) quality and in - process control costs ; ( g ) a charge for overhead costs proportional to the total daily rate for the plant for manufacturin g plant administration and plant management, material s management, storage and handling, manufacturing a nd employee training, and all administrative costs ass ociated with the manufacturing operation of the sit e ( including human resources, information technology and finance costs ; raw material and raw material warehouse cos ts shall be charged directly to the process order ) ; ( h ) charges for spoilage, scrap or rework costs ; and ( i ) charges for shipping ( including all duties a nd import fees )