definiens: shaLL mean a New Drug Application as defined In the Act filed with the FDA . for marketing aulhofization of Products in the US 1.37 shan mean with respecllo any Product . the gross amount invOiced by Licensee or its Affiliates or Sublicensees from sales of Product In the Terntory . commencing upon the date of First CommerCial Sale, less deducliOns for : ( a ) transportation charges ( freight, shipping and distribution ), Including insurance actually paid for distribution of Product ; ( b ) sales, value - added and excise taxes, and other taxes, dulies or surcharges paid or allowed by a selling parly and any other goverrvnental charges imposed upon the sale or use of Product ; ( e ) any other fees paid 10 distributors, consignees or agents in ronnection with the sale of Product ; ( d ) allowances or credits to customers, nol in excess of the selling price 01 Product, on account of governmental requirements, rejection, outdating or return of Product ; ( e ) rebates or premiums granted or i : lllowed to customers In connection with the sale of Product ; ( f ) trade, quantity, or cash discounts, charge backs or retroactive price reductions granted in connection with tl'l & sale of Product ; and ( g ) write oHs fO ( bad debts . Net Sales shall be determined at the time such Net Sales ere recognized as revenue in accordance wilh GAAP by licensee end ell accounting terms used shell be Inlerpreted In accordance with GAAP