definiens: means, 5Ub)ect to Sections 3.5(h ) . 3.8(h ), IS.1 and 15.2(a ) . Ihasc : FTE Costs and out - of - pocke t COlIS ( mc : luding ... ilhout limilation filing, uscr, maintenance and other fetli paklto Rqula .,ry Authorities ) inC\ll'red by a Party or any of its AffiliaES m accordance wilb GAAJ > aner the EffectlYC Date during the Itnn of and pursuant to this Agreemen t in eonn«tion with the IpTq)lfllrion of product reJlUbtory submissions l. the obtaining and maintel\allct of Approval of Licxmcd Product lin the Co·J > romouon Territory and in the EU ], and compliance with Approv.ls and rcquiremenl5 of weh regulatory authorities ( including without limitation IthoJ > t regulatory filmi fees in the Co - Promotion Territory described in Section 3.8{h)l ) . ladvcrse event recordatlonl gnd reporting, IregulDtory affairsl activities, and lrecalls Dnd withdm ..... llist of Ucenscd Product