definiens: means the direct variable costs and direct fixed costs associated with the manufacture of the Product ex - factory . Direct variable costs shall be deemed to be the cost oflabor, raw materials, supplies and other resources directly consumed in the manufacture 2 298928.1 Confidential material omitted and filed separately with the Securities and Exchange Commission . Asterisks denote snch omissions of such Product . Direct fixed costs shall be deemed to be the cost of facilities, utilities, insurance, equipment depreciation, allocable manufacturing administration, and other fixed costs directly related to the manufacture of such Product . Direct fixed costs shall be allocated to such Product based upon the proportion of such costs directly attributable to support ofthe manufacturing process for such Product . If a facility ( not solely dedicated to the manufacture of the Product ) is used to manufacture products for other programs of a Party, direct fixed costs shall be allocated in proportion to the actual use in days to manufacture the Product divided by the total number of days available on an annual basis ( 365 ) . Except as otherwise provided in this Agreement, all cost of goods determinations made hereunder shall be made in accordance with US GAAP