definiens: means, with respect to a quantity of Development Material, the cost of goods of such Development Material [ * * * ] . To the extent Development Material is Manufacture d directly by MTEM, the cost of goods will equal the fully bur dened cost of Manufacturing such Development Materi al, consisting of the cost of raw materials, direct and identifiable labor, product quality assurance / cont rol costs and other direct and identifiable variable costs and ap propriate direct and identifiable costs ( or appropr iate allocation thereof ) yield losses ( to the extent consistent wit h industry practice ), storage, and shipping, rent a nd depreciation of capital expenditures, to the extent directly att ributable and allocable to the Manufacture of such Development Material . Without limitation to the foregoing, ( a ) should any facility or equipment not be used to the ir full capacity for the Manufacture of Development Material, alloca tions shall be on the basis of that actually used f or the Manufacture and supply of such Development Material and not any amount in respect of idle or unused ca pacity ; and ( b ) the costs of goods ( i ) will be calculated i n accordance with applicable Accounting Standards a nd include allocations that are commercially justifiable and c onsistent with fair industry practices, ( ii ) will e xclude all costs that can not be linked to a specific Manufacturing a ctivity, such as charges for corporate overhead tha t are not controllable by the manufacturing plant, and ( iii ) will exclude any Third Party license payments owed or incurred by MTEM in connection with any Manufacturing activi ties . Cost of goods shall not include ( A ) costs tha t are expressly allocated to be borne by MTEM under this Agreement ( e.g., under Article II ), ( B ) costs associated with capability building, unless expressly agreed in wri ting by the Parties, or ( C ) any inter - company mark- up between MTEM and its Affiliates . To the extent MTEM uses a contract manufacturer for any of such activities, t he cost of goods means the amount paid to the applicable contr act manufacturer, including any raw materials, reag ents or other components directly purchased by MTEM on beha lf of the CMO and any related shipping costs includ ing shipping insurance costs . In no circumstances will the costs incurred by MTEM, and used to calculate t he Supply Price, be double counted