definiens: means the gross amount invoiced by or on behalf of the relevant Selling Entity for the Productsold to third parties other than any other Selling Entity, less the Permitted Deductions, all calculated on an accrualbasis, as determined in accordance with the applicable Selling Entity ’s usual and customary accounting methodsconsistent with the treatment of other branded prescription products commercialized by the applicable Selling Entity, which shall be in accordance with United States generally accepted accounting principles or International FinancialReporting Standards, as applicable, including the accounting methods for translating activity denominated in foreigncurrencies into United States dollar amounts . In the case of any sale of the Product between or among the Company, its Affiliates, licensees and sublicensees, for resale, Net Sales shall be calculated as above only on the valuecharged or invoiced on the first bona fide arm’s - length sale thereafter to a third party . For the avoidance of doubt, inthe case of any sale of the Product between or among the Company, its Affiliates, licensees and sublicensees wheresuch Affiliate or licensee is an end - user of, and does not further sell, the Product, Net Sales shall be calculated on thevalue charged or invoiced to such Affiliate, licensee or sublicensee . In the case of any sale for value other thanexclusively for money ( but excluding any compassionate use, early access, indigent patient and patient assistance ordiscount programs ) on bona fide arm’s - length terms ( which has the effect of reducing the invoiced amount below whatit would have been in the absence of such non - monetary consideration ), Net Sales shall be calculated at the averageNet Sales price charged to third parties for cash sales of the Product in the jurisdiction of sale during the relevantreporting period unless such sales in the jurisdiction during the relevant period were only de minimis cash sales, inwhich case at the fair market value as determined by comparable markets . Notwithstanding the foregoing, thefollowing ( including whether such amounts actually exist or are deemed to exist for purposes of calculation ) shall notbe included in Net Sales : ( i ) Product provided for administration to patients enrolled in clinical trials or for otherresearch purposes, ( ii ) Product distributed through a not - for - profit organization or otherwise at no or nominal charge toeligible patients in conjunction with any compassionate use, early access, indigent patient or patient assistanceprogram or ( iii ) Product used for test marketing, promotional or sampling purposes