definiens: means gross amounts invoiced by or on behalf of Licensee and any of its Affiliates or Sublicensees ( each a ) for Product s old to Third Parties, less the following deductions, as determined in accordance with Licensee ’s usual and customary accounting methods, which are in accordan ce with GAAP or IFRS ( as applicable and as generally a nd consistently applied throughout Licensee ’s organization ) to the extent included in the gross i nvoiced sales price of Product or otherwise directl y paid or incurred by a Selling Party with respect to the sal e of Product : [ * * * ] Each of the deductions set fort h above shall be determined on an accrual basis in accordance wit h GAAP or IFRS, as applicable . For purposes of dete rmining Net Sales, a Product shall be deemed sold when invo iced and a shall not include transfers or di spositions of such Product for pre - clinical or non - commercial clinical purposes, as samples or under named patien t use, compassionate use, patient assistance, or test mark eting programs or other similar programs or studies