definiens: means, with respect to any Combination Product, the gross amount billed byBiodel, its sub - licensees and their respective Affiliates for the Combination Product less the following : ( i)normal and customary trade, quantity and/or cash discounts, returns or credits ( including due torejections, defects or recalls of the Combination Product or because of rebates or retroactive priceadjustments ), allowances, rebates and charge - backs, to the extent actually accrued ; ( ii ) sales taxes, value - added taxes, excise or use taxes, tariffs, duties and customs fees and other taxes ( excludingincome taxes ), duties or other governmental charges imposed with respect to sales of the CombinationProduct that are actually paid ; ( iii ) credits or allowances given or made for rejection or return of, and foruncollectible amounts on, previously sold Combination Product or for rebates or retroactive pricereductions ( including Medicare, Medicaid and similar types of rebates and chargebacks ) ; and ( iv ) freight, postage, shipping, insurance and other transportation expenses associated with the Combination Productthat are itemized in the gross amount billed and are actually paid by [COMPANY] or its Affiliates or sub - licensees . All calculations shall be made in accordance with U.S. generally accepted accountingprinciples