definiens: shall mean the gross amounts received by Company a nd its Affiliates ( but not their respective Licensees ) following the First Com mercial Sale of a Product for sales of such Product to Third Parties that are not Affiliates or Licensees of the selling party ( unless such Affiliate or Licensee i s the end user of such Product, in which case the amount billed there for shall be deemed to be the amount that would be billed to a Third Party end user in an arm’s - length transacti on ), less the following items, as allocable to such Product ( if not previously deducted from the amount invoiced ): ( i ) bad debts actually written off which are attrib utable to sales of Products ; ( ii ) trade discounts, credits or allowances ; ( iii ) credits, refunds or allowances a dditionally granted upon returns, rejections or recalls ; ( iv ) f reight, shipping and insurance charges ; ( v ) taxes, duties or other governmental tariffs ( other than income taxes ) ; ( vi ) any payment in respect of sales to any government al authority in respect of any government - subsidized p rogram, including, without limitation, Medicare and Medicaid rebates ; and ( vii ) distribution, packing, handling and transportation charges for Products to the extent that they are included in the price or otherwise pa i d by the customer