definiens: means the gross amount invoiced for sale of a Product in the Territory by a Party or any of its Affiliates, licensees or sublicensees, to a Third Party end user, including but not limited to distributors, in bona fide, arm's - length transactions, after deduction of the following items ( to the extent actually incurred or reasonably estimated and accrued and to the extent not already deducted in the amount invoiced ): ( i ) customary trade, quantity and cash discounts, wholesaler - charge backs, or rebates ( including, but not limited to, rebates to governmental agencies, managed care organizations, health management organizations, pharmacy benefit managers and group purchasing organizations ) ; ( ii ) customary credits or allowances for rejection or return of previously sold Products ; ( iii ) excise, sales and other consumption taxes and customs duties ; ( iv ) retroactive price reductions including but not limited to those imposed by governmental agencies ; and ( iv ) any charge for freight or insurance if separately stated on the same invoice as for the sale of Product and directly related to the sale or distribution of the Product . A of a Product is deemed to occur upon the invoicing, or if no invoice is issued, upon the earlier of shipment or transfer of title in the Product to a Third Party