definiens: means, with respect to any Preclinical Materials or Clinical Materials manufacturedby [COMPANY], [COMPANY] ’s fully - burdened costs ( including the costs associated with product testing and release activities)of producing and packaging such Preclinical Materials or Clinical Materials, including the sum of the following components:(a ) direct costs, including ( 1 ) materials directly used in producing and packaging such Preclinical Materials or ClinicalMaterials and ( 2 ) with respect to any Preclinical Materials or Clinical Materials obtained by [COMPANY] from a Third Partyand supplied to sanofi - aventis without modification, the amount paid by [COMPANY] to such Third Party for the same ; ( b)manufacturing overhead costs attributable to the cost of goods under the foregoing clause ( a ) ( 1 ), including manufacturingand quality labor and manufacturing and quality supervisory services, operating and administrative costs of themanufacturing and quality departments and occupancy costs which are allocable to company departments based on spaceoccupied or headcount or another reasonable activity - based method ; for the purpose of clarity, any cost allocation shall be ( i)in any case, applied in accordance with GAAP, and ( ii ) applied consistently by [COMPANY] in relation to all other ThirdParties for which [COMPANY] manufactures comparable materials ; ( c ) any other reasonable and customary out - of - pocket costsborne by [COMPANY] for the testing, transport, customs clearance, duty, insurance and/or storage of such Preclinical Materialsor Clinical Materials ; and ( d ) [COMPANY] ’s general and administrative costs, including purchasing, human resources, payroll, information system and accounting, which are directly attributable or reasonably allocable to company departments based onspace occupied or headcount