definiens: means [COMPANY] ’s fully - burdened aggregate cost of Manufacturing, or having Manufactured, a particular Supplied Item, determined and recorded in accordance with Accounting Standards, consistently appliedthroughout the [COMPANY] organization for financial reporting purposes, calculated on a per - unit ( by SKU ) basis . Suchcosts include, without limitation : ( a ) in the case of a Supplied Item, raw materials, API, Drug Product, Devices, Device components or other materials supplied by a Third Party, the amounts paid by [COMPANY] or its Affiliate tosuch Third Party for the applicable items ( without mark - up of the Third Party ’s invoice ) ; ( b ) in the case of otherManufacturing activities performed by a Third Party, the amounts actually paid by [COMPANY] or its Affiliate to suchThird Party for performance of such activities ( without mark - up of the Third Party ’s invoice ) ; ( c ) in the case ofManufacturing activities performed by [COMPANY] or its Affiliate, [COMPANY] ’s or its Affiliate ’s costs of performingsuch activities . For clarity, these costs include : ( i ) standard unit cost of such Supplied Item, consisting of directmaterials, direct labor, and production overhead ( including depreciation ) directly attributable to such Supplied Item, atstandard ; and ( ii ) cost variances, consisting of direct materials variances, including material usage variances andpurchase 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 [ redacted in accordance with Section 12.2(3 ) of National Instrument 51 - 102 ], excluding such indirectoverhead costs, and will be lowered based upon increased volume of purchases on a sliding scale ( e.g., [ redacted inaccordance with Section 12.2(3 ) of National Instrument 51 - 102 ] . The JSC will discuss indirect overhead costs on anannual basis