definiens: shall mean : ( a ) if Product IS manufactured by Oscient or a subcontractor therewith, the direct labor and materials cost, regulatory compliance activities, quality assurance and quality control, supply chain management, pharmacovigilance and logistics calculated in accordance with U.S. generally accepted accounting principles consistently applied, or ( b ) ( i ) the price charged to Oscient by a third party manufacturer for the manufacture and supply of each Product 's active pharmaceutical ingredient and fill and finish of the Product tablets, ( ii ) Oscient 's overhead reasonably allocable to regulatory compliance activities, quality assurance and quality control, supply chain management, pharmacovigilance and logistics, provided that, such Oscient overhead expenses to be charged to [COMPANY] Mexico shall be no greater than $ 0.03, and ( iii ) customs duties, fees, taxes and other charges incurred in importing the active pharmaceutical ingredient into the United States ; provided that, the Parties agree that Actual Per Tablet Costs shall not include any Packaging - Related Manufacturing Costs