definiens: means, with respect to any Preclinical Materials or Clinical Materials manufactured by [COMPANY], [COMPANY] ’s fully - burdened costs ( including the costs associated with product testing and release activities ) of producing and packaging such Preclinical Materials or ClinicalMaterials, including the sum of the following components : ( a ) direct costs, including ( 1 ) materials directly used in producing and packaging such PreclinicalMaterials or Clinical Materials and ( 2 ) with respect to any Preclinical Materials or Clinical Materials obtained by [COMPANY] from a Third Party and suppliedto [COMPANY] without modification, the amount paid by [COMPANY] to such Third Party for the same ; ( b ) manufacturing overhead costs attributable to the cost ofgoods under the foregoing clause ( a ) ( 1 ), including manufacturing and quality labor and manufacturing and quality supervisory services, operating andadministrative costs of the manufacturing 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 inaccordance with GAAP, and ( ii ) applied consistently by [COMPANY] in relation to all other Third Parties for which [COMPANY] manufactures comparablematerials ; ( c ) any other reasonable and customary Out - of - Pocket Costs borne by [COMPANY] for the testing, transport, customs clearance, duty, insuranceand / or storage of such Preclinical Materials or Clinical Materials ; and ( d ) [COMPANY] ’s general and administrative costs, including purchasing, humanresources, payroll, information system and accounting, which are directly attributable or reasonably allocable to company departments based on spaceoccupied or headcount