definiens: shall mean, [ with respect to Licensed Product or API, as the case may be, for successful and failed lots, the sum of the following, all of which shall be calculated in accordance with GAAP ; provided that in no event shall any expense be double­counted or included in Fully Burdened Manufacturing Cost if such expense has already been accounted for elsewhere : A. The amounts paid by LICENSEE or its designee to LICENSOR or a Third Party for : ( i ) providing the chemical and biological substances required for the manufacture of the Licensed Product or API, as the case may be, ( for purposes of this Exhibit A, collectively, the ) and packaging materials for producing such Licensed Product or such API ; ( ii ) manufacturing, filling, and/or finishing Licensed Product or API, as the case may be, or any component thereof ; ( iii ) distributing, transporting, storing, and insuring Licensed Product or API, as the case may be ; and ( iv ) testing Licensed Product or API, as the case may be, including with respect to the foregoing, all sales and excise taxes and customs duty charges imposed by Governmental Authorities with respect thereto to the extent actually paid by LICENSEE or its designee and not reimbursed, offset, credited, or refunded by a Third Party ; and B. which means those material, labor, and service expenses captured in time sheets and invoices, that are specific for Licensed Product or API, as the case may be, including without limitation Direct Material Expenses, Direct Labor Expenses and Direct Services Expenses . means cost of filters, manufacturing supplies, solvents, containers, container components, packaging, labels, and other printed materials used in production . means salaries, payroll taxes, and benefits actually paid for personnel directly involved in manufacturing Licensed Product or API, as the case may be . shall mean actual out - of - pocket payments to Third Parties for services required in the manufacture of Licensed Product or API, as the case may be, but excluding taxes paid on such services which are creditable against manufacturing excise taxes or VAT ; and C. which means a reasonable allocation of expenses associated with personnel supporting the direct manufacturing of Licensed Product or API, as the case may be, in accordance with GMP requirements, including without limitation labor and overhead for quality control, quality assurance, Raw Material acquisition and acceptance, microbiology, document control, calibration / validation, and non - research and development expenses for Licensed Product or API, as the case may be, development and analytical methods development supporting manufacturing, but excluding Direct Expenses, interest expenses, and capital expenditures for facilities and equipment used to manufacture Licensed Product or API, as the case may be ; and D. which means direct and indirect manufacturing costs with respect to Licensed Product or API, as the case may be, that can not be identified in a practical manner with specific units of production and, therefore, are not to be included in Raw A - I Material, Direct Expenses, or Indirect Expenses