definiens: means : ( a ) With respect to Licensed Product manuf actured by [COMPANY], its fully - burdened costs ( including the costs associated with product testin g and release activities ) of producing ( including s tartup and validation but excluding what will be covered under Section 4.3.3 ) and packaging Licensed Product for sale in a given country, determined in accordance with the ap plicable Accounting Standard, based on the sum of t he following components : ( i ) direct costs, including m anufacturing labor and materials directly incurred in producing and packaging such Licensed Product ; ( ii ) manufactu ring and accounting personnel costs incurred by Med genics and attributable and reasonably allocable to the ma nufacture of Licensed Product, including quality la bor and manufacturing and quality supervisory services, dep reciation, and other operating and administrative c osts which of the manufacturing, quality and accounting depart ments and associated occupancy costs which are allo cable to such company departments based on space occupied or headcount, or other activity based method of alloc ation ; ( iii ) any other reasonable and customary Out - of - Poc ket Costs incurred by [COMPANY] for the testing, tr ansport, customs clearance, duty, insurance and/or storage o f such Licensed Products, including payments made b y [COMPANY] to Third Parties for filing, finishing, p ackaging, labeling, testing, storage and shipment o f such Licensed Product and [COMPANY] ’ handling cost with respect t hereto, as applicable ; and ( iv ) [COMPANY] ’ reasonab ly allocated share of cost of Licensed Product process improvements developed by [COMPANY] or a Third Par ty on behalf of [COMPANY] . For Licensed Products manufact ured by [COMPANY], Manufacturing Cost will not incl ude any general corporate overhead, any excess capacity cost or charges or cost for process development ( e xcept to the extent expressly provided above )