definiens: N'DA " shaH mean any and at ) : rpplication . ( new drug applications ) submined to the FDA unda Sections 505 . 507 or 512 of ! he FD&C .<\ct and applicable regulations related to the Product, inelllding without limitation, full NDll . S, NOAs and abbreviated NDA~ ( ANDAs ) ! md all amendment~ and supplements thereto or equivalent applications in the EuropelUl Union, 1.15 " ' Net Sales~ shaU be calculated as follows : From the gross invoice price ofehe ProdllCe sold by Yanda or its Affiliates or Sub - lictnRE : eS to independent third pa.rties in bona fide, arms - length trnnsactions there shall be subtracted, if not previously deducted in Ille amount invoiced fH received . ( i ) quiUllity and cash discounts Bemally ullowcd or taKen, ( il ) freight, postage lind _ hipping in.urance allO " and l3>;e5, if : ; Iny, directly related to the sak, ( iv ) lUlloum~ repaid or crMiteel by rea!lOn ofrejection <, retum of 800<13 Bnd retroactive price reductions mandated by or ItJ'lIDted in ' < : SpOnse tn state . provinda l 0 ' fedcrnlla w or regulation lind .'pecifico.lly Identifiable as relating to the Prodl1ct, ( v ) I\[J}OUl1 t ~ incurred as II re < ul ! of govemme lllal ( or go\'emmcmalllgency ) mandated rebate programmes, ( nt actually aJlo ~ d and ( vii ) lIS agreed by the parties in writing, any other spcdfiCJIUy identifiable amounts inl, elC or ullimate!y will he credited and that are substantially similar 10 those liSll:<l . a bov~ . The computation on'-lct Sales shall nol include saks between or among II pany and iL~ AffiJialn5Ces, except where such Affili atc~ or Sub - licen . 'cc ! ~re eml uscrs . For the pUITKr.ltS of thi.~ Sublieen"~ Agreement, sales oflbe Prodocllo indep = de nl diSlributors, wholesalers 0 ' otber parties who purcll3.'IC and tnke title to the Product are con ~ idcred to be sales to tbird parties . If the Product i~ sold thlO\Jgh inlennediarics such as ag.ents or co·promo tCTS who do not purchase and U1ke tille 10 the Product, rOYil)lies shnll be due On Net Sales 1 (, third parties who purchase the Product thmll&h such intermedi : ll ies . It is agreed that tbere shall be no sales of the Compound to ' Third Partiu hy or on behalf of Vanda, its Affiliates OJ Sub - Jicem:.ees.-Jn the event there a, e sales of Compound to Third Panics by or on behalf ofVanda, its Affili3te.s or Sub- licen ~ s, such ! ' Illes shall be Sllbject to the r'IIymcnt or royalties by Vallda 10 Nov;uti5 ( as the case may be ) to the Saine e)(te1111l~ paymenl~ ( ) f royalties arc due ~'n ; ~le8 of the Product pUT ~ uant 10 Ihi~ St ~ l > licenYC Agreo < lllcnt