definiens: means costs associated with producing the Product for commercial supply for the Shared Territory, in either bulk or final fonn, incurred by [COMPANY] or its Affiliates, and which shall be the sum ofthe following : ( i ) The amounts paid by [COMPANY] to [COMPANY] or a Third Party for manufacturing, testing, filling, packaging, and/or finishing services for the Product, or any component thereof ( including without limitation amounts paid by [COMPANY] as a purchase price for the Device and the Product for the Shared Territory pursuant to Section 9.1 of the Agreement ) ; and ( ii ) which means those material, labor, and service expenses captured in time sheets and invoices, that are allocable to or used in the manufacture, finishing, filling, or testing of the Product or components thereof, including without limitation ( a ) the cost of raw materials, filters, manufacturing supplies, solvent, containers, container components, packaging, labels, and other printed materials used in production ; ( b ) salaries, payroll taxes, and benefits actually paid for personnel directly involved in supply of the Product to the extent not calculated on an FTE basis ; ( c ) the cost of process improvements, manufacturing scale up, and manufacturing site qualification occurring after Regulatory Approval of the Product ; and ( d ) reasonable FTE costs and direct out - of - pocket costs recorded as an expense by [COMPANY] in accordance with IFRS or lAS in connection with the manufacture of the Product or components thereof, in each case which costs shall be consistent with the applicable Commercialization Plan ; and ( iii ) which means a reasonable allocation of expenses associated with [COMPANY] 's personnel supporting the supply of the Product or components thereof, including without limitation expenses of labor and overhead for quality control, quality assurance, raw material acquisition and acceptance, microbiology, document control, calibration / validation, but excluding without limitation Direct Expenses, interest expenses, and depreciation on capital expenditures for facilities and equipment used to manufacture the Product ; and The information contained in this exhibit has been omitted and filed separately with the Securities and Exchange Commission . Confidential treatment has been requested with respect to the omitted portions