definiens: or means the actual fully burdened costs and expenses of manufacturing for the Supply Product in the Territory, which costs and expenses include, w ithout limitation, the costs of all raw materials and labo r ( including all allocable benefits ) used or consum ed in such manufacture, the costs of storage, Third Party cont ract manufacturing costs ( but excluding any costs w ith respect to manufacturing development by a Third Party and / o r facility expansion and/or build - out ; all of the f oregoing are handled as provided in Section 2.2(a ) ), packagi ng costs and expenses, all quality assurance and qu ality control related expenses, all other regulatory cost s and expenses, and all overhead amounts specifical ly allocable to such manufacturing ( but explicitly excluding exe cutive management and related overhead relating to executive management with broader responsibility th an solely manufacturing ; capital equipment costs an d start - up costs, whether or not amortized ; and costs of ex cess capacity ), and all royalty amounts payable by [COMPANY] to any Third Party due to the manufacture of Supply Product, all of the foregoing as calculated in acc ordance with US generally accepted accounting principles co nsistently applied