definiens: shall mean the costs incurred ( i.e., paid or accrued ) by a Party . its Affiliates or ~ents in the Manufacture of a Product, Placebo or Diluent, as applicable, which shall beJ.lt'e sum of direct labor, direct material and overhead incurred in the Manufacture of such Product, Placebo or Diluent as determined in accordance with GAAP as consistently applied by such Party and its Affiliate ; } Fully Burdened Manufacturing Cost shall excludef'costs relating to the 20 kg Manufacturing process scale - up, validation of the 20 kti, akmacturin g process or the Regulatory Approval of the 20 kg Manufacturing proces that are required to obtain Regulatory Approval for the Medisorb Product for the In ! lallndication ( which costs shall be borne solely by [COMPANY] ) . In addition, for the avoidance of doubt, any Manufacturing development costs that are included in Shared Expenses as Development Costs shall not be included as part of the Fully Burdened Manufacturing Cost