definiens: means [COMPANY] ’s fully - burdened aggregate cost of Manufacturing, or havingManufactured, a particular Supplied Item, determined and recorded in accordance with Accounting Standards, consistently applied throughout the [COMPANY] organization for financial reporting purposes, calculated on a per - unit(by SKU ) basis . Such costs include, without limitation : ( a ) in the case of a Supplied Item, raw materials, API, DrugProduct, Devices, Device components or other materials supplied by a Third Party, the amounts paid by SteadyMedor its Affiliate to such Third Party for the applicable items ( without mark - up of the Third Party ’s invoice ) ; ( b ) in thecase of other Manufacturing activities performed by a Third Party, the amounts actually paid by [COMPANY] or itsAffiliate to such Third Party for performance of such activities ( without mark - up of the Third Party ’s invoice ) ; ( c ) in thecase of Manufacturing activities performed by [COMPANY] or its Affiliate, [COMPANY] ’s or its Affiliate ’s costs ofperforming such activities . For clarity, these costs include : ( i ) standard unit cost of such Supplied Item, consisting ofdirect materials, direct labor, and production overhead ( including depreciation ) directly attributable to such SuppliedItem, at standard ; and ( ii ) cost variances, consisting of direct materials variances, including material usage variancesand purchase price variances, direct labor variances, and production overhead variances, including variable and fixedproduction overhead spending variances . In no circumstances, however, may the indirect overhead costs defined in(d ) exceed [ ... * * * ... ], excluding such indirect overhead costs, and will be lowered based upon increased volume ofpurchases on a sliding scale ( e.g., [ ... * * * ... ] . The JSC will discuss indirect overhead costs on an annual basis