definiens: means a /New Drug Application or the equivalent, and all supplements pursuant to the requirements of the FDA, including all documents, data and other information concerning Products which are necessary for FDA approval to market a Product, or the equivalent governmental approval in any other counITrJ 1.51 shall mean, with respect to Product(s ), ~ gross amount invoiced to non - affiliated customers for all Product ( s ) sold by [COMPANY], its Affiliates, Licensors, or Licensees to the first independent Third Party, including distributo ~ le ss the following items : i ) trade, and/or, quantity discounts, cash discounts, bad debt, sales and excise taxes, freight or other transportation costs, insurance charges, additional special packaging, duties, tariffs, and other governmental charges ( other than and an income tax ), actually paid or allowed ; ii ) the standard inventory cost of devices used for dispensing or administering the Product(s ) which accompany the Product(s ) as they are sold ; iii ) credits, charge - back rebates, reimbursements or similar payments granted or given to wholesalers and other distributors, buying groups, health care insurance c, arriers, governmental agencies and other institutions, but only to the extent actually allowed ; iv ) credits or allowances for rejection or return of Products previously sold ; and v ) payment or rebates actually paid in connection with government sponsored health insurance programs