definiens: means, with respect to a Licensed Product for any period, the gross amount billed or invoiced by Sanofi or any of its Affiliates or its or their Sublicensees for the sale of a Licensed Pr oduct to a Third Party commencing with the First Commercial Sa le of such Licensed Product less the following dedu ctions determined in accordance with Accounting Standards from such gross amounts which are actually incurred, allowed, accrued or specifically allocated : [ * ] Any of the deductions listed above that involves a payment by Sanofi, its Affiliates or its or their S ublicensees shall be taken as a deduction in the Calendar Quart er in which the payment is accrued by such entity . For purposes of determining Net Sales, a Licensed Produ ct shall be deemed to be sold when [ * ] . Net Sales s hall not include transfers or dispositions of such Licensed Product for pre - clinical or clinical purposes, comp assionate use or as samples, in each case, without charge . Su ch Party ’s, its Affiliates ’ or its or their Sublice nsees ’ transfer of any Licensed Product to an Affiliate or Sublicen see shall not result in any Net Sales unless the tr ansferee is an end user