definiens: means the cost of a Product or Product Component, as applicable, in bulk or finished form ( including samples ) calculated in accordance with GAAP . Cost of Goods shall include : ( a ) the cost of manufacture for a Product or Product Component, as applicable, manufactured by [COMPANY] or the amount paid for Product or Product Component manufactured by a Third Party ; ( b ) the net cost or credit of any value - added taxes or duties actually paid or utilized in respect of the Product or Product Component ; ( c ) the cost of freight, insurance and other transportation charges for the Product or Product Component to the extent not invoiced to Third Parties and ( d ) the cost of any royalty payments paid to [COMPANY] or Third Parties necessary for the manufacture, use or sale of ( ! Third . v Party Cytokine, [COMPANY] Product Component or Producf } For purposes of this ~ definition, means the fully allocated cost of manufacturing a Product or Product Component, as applicable, ( calculated in accordance with GAAP applied on a basis consistent with [COMPANY] 's past practices ), excluding start up expenses and including the direct and indirect cost of any raw materials, packaging materials and labor ( including benefits ) utilized in such manufacturing ( including formulating, filling, finishing, labeling and packaging, as applicable ) plus factory overhead ( fixed and variable ) allocated to such Product or Product Component