definiens: means a new drug applkatioll . health registration, marketing aulhorization upplication, common technical document, regulatory submission, notice l)f cOfnpliance Dr equivalent applkalior ) ( excluding lncal lHtd general business llcemcs and permits ) required to be appnwed hef()re c{)mrnercial sale ot Usc ofthe Prmillcl as a pharmaceutical Dr medicinal product ill a Jurisdiction ( including, wilh respect to any Jl1riiidiction tither than t1le U.S., any Pricing, APPI'oVttls and/or Re : imhursem .ent Approvals that are c{"\mmercially llcccssary prior to commcrcial.sale OfSllCh Product in such Jurisdiction }, mgethcr with all slIhs(.'qucnt submissions, supplements ~'\.nd amcndlnents . thereto . including an NDA in the U.S. or local approvals ill the lurisdictintl$ iiS applicable, 1.55 means the FDA . the EMEA and any health regulatory authorities in lhe Territory Of Jurisdiction that hold responsibility for the regulation of and/or the Reimbursement Dfmcdicinal products . intended thr humal1 use, ] .56 means ( 111 submissions to Regulatory Authorities and other Governmental Entities, jncluding for Clinical Trials, Non - Clinical Trials, Preclinical CONFIDENT[AL 10 Trials, tests, find biostudics, relating to the Product including all INDs, Regulatory Approval Applications and Regulatory Approvals, as well as all correspondence with Goven1mciltal Entities ( registration and licenses, Pricing and Reimbursement cnrrcspondcncc, regulatory drug lists . advertising and promotion documents ), adverse event files . complaint tifes . manufacturing records and i1l.spectlol ) reports