definiens: with respect to a Lead Compound shall mean all costs to produce, package anddistribute the product to [COMPANY] or its carrier at the Ex Works location ( in compliance with Section 12.6 ) and anyroyalties or other consideration ( not reimbursed by [COMPANY] ) paid to third parties related to the acquisition or sale ofproduct, with costs to produce and package the product to include the direct material, labor and indirect costs that areincurred by FG or its Affiliate(s ) associated with the manufacture, filling, packaging, labeling, preparation of product forshipment and/or other preparation of such Lead Compound, as applicable, including, but not limited to taxes, fees, and customs incurred, as applicable . Costs will be determined in accordance with U.S. Generally AcceptedAccounting Principles ( U.S. GAAP ) and will include but not be limited to the costs of facilities, labor, purchasing, depreciation of equipment, materials, payments to third parties for any necessary contract work related to themanufacture or testing of the product, the validation studies, quality assurance, quality control and other testing, storage, shipping ( if requested by [COMPANY] ), costs related to distribution and a reasonable allocation of general andadministrative overhead . Costs related to distribution include the labor, materials and overhead necessary to prepareand package the final product for shipment to the Ex Works location