definiens: means the first approvals, licenses, regisIJ"aIiODS, CE Marking or autho ~ tions of any nalional, SUpl1l - national ( c. S., tile FDA, the EMEA or Koseisho ), state or local regul : ifory agem : y, dcpanmenl, bureau, oommission, councilo r other governmental entity, sufficient for the manufacture, distribution, usc and sale of Liccnsed Product in a regulatory jurisdiction in accordance with oPfllicsble lawsl, including receipt of rriting and reimbursement IIIJprovals l _ 1.52 mcans Ihe first approvals, licenses, registrations, CE Marking or authorizations of any national, supra·notional ( e.i-, the FDA, the EMEA or Koseisho ), stlte or local regulatory agency, department, bureau, commissio n, councilor other governmc : ntll entity, sufficient for the : manufacrure, distribution, usc and sale of Licensed Product in a regulotory jurisdiction in accordance with applicable laws/, excluding m : c : ipt of pricing and reimbursement approvals J