definiens: shall mean an application to market a new drug filed with the Food and Drug Administration, or any successor agency, in the United States pursuant to Section 505 of the Federal Food ., Drug and Cosmetic Act and 21 C.F.R. Part 314, or any successor provisions thereto ( or the equivalent application with the governing health authority of any other Primary Country ) . ' 1.11 with respect to any Product shall mean the invoiced sales price of such Product billed to independent customers ( who are not Affiliates ), less, to the extent such amounts are included in the invoiced sales price, actual credited allowances to such independent customers for such Product which was spoiled ., damaged ., out - dated or returned ., and less actual ( a ) freight and insurance costs incurred in transporting such Product to such customers ; ( b ) quantity and other trade discounts ( including prime vendor rebates ) actually allowed and taken ; ( c ) customs duties and surcharges and other governmental charges incurred in cOlUlection with the exportation or importation of such Product in final fonn ; and ( d ) liabilities incurred resulting from any government ( or agency thereof ) mandated rebate program, whether Federal, State, Municipal or Local ; provided, however, that, with respect to any Product in any country, the sum of the amounts in clauses ( a ), ( b ), ( c ) and ( d ) with respect to such Product in such country, when expressed as a of the invoiced sales of such Product in such shall not exceed 2