definiens: means, with respect to a Product, the aggregate o f each Party ’s and its Affiliates ’ cost to Manufacture, perform quality co ntrol and assurance activities, test, package and l abel and release such Product for commercial use, in all cases deter mined from the books and records of such Party or i ts Affiliates maintained in accordance with the Accounting Standa rds, which costs may include ( but not necessarily b e limited to ) the following : ( a ) the [ * * * ] of [ * * * ] ; variable and fixed produ ction costs, including factory overhead ; purchase price variances ; [ * * * ] revaluations, inclu ding [ * * * ] destroyed or written - off ; change in valu e of [ * * * ] provisions ; production variances ; Manufacturing pla nt labor ; a [ * * * ] of plant overhead expenses ( inclu ding insurance, facility, and support staff personnel ) ; materials and supplies ; maintenance ; discards ; depr eciation and amortization ; ( b ) payments to Third Parties for [ * * * ] or [ * * * ] necessary for, or [ * * * ] and/or [ * * * ] determined in accordance with [ * * * ], for the commer cial Manufacture, performance of quality control an d assurance activities, testing, releasing, packaging and/or labeling may be treated as part of the Cost s of Goods Sold for such Product and then such amounts shall not be included in any [ * * * ] payable under [ * * * ] ; and ( c ) with respect to any newly constructed or oth er dedicated Manufacturing facility, whether such facility is owned by a Party or a Third Party, that will be utilized in the Manufacture of a Prod uct, if a Party determines it will build or utilize a facility with [ * * * ] relative to the [ * * * ] for the Product(s ) to be Manufactured in such facility, any decision to account for plant [ * * * ] for such facility [ * * * ] such [ * * * ] in the co mputation of Cost of Goods Sold must be approved by the Parties