definiens: means, as applicable, ( i ) with reference to the U nited States, the approval of an NDA by the FDA necessary for the manufacture and commercialization of a pharmaceutical, biologic or device product in the United States, ( ii ) with refe rence to the European Union and/or United Kingdom, the approval of an NDA by the EMA or the European Commi ssion filed pursuant to the centralized approval procedure and necessary for the manufacture and com mercialization of a pharmaceutical, biologic or dev ice product in the European Union and/or United Kingdom, ( iii ) with reference to a Major Market Country, t he approval of an NDA by the applicable regulatory aut hority in such Major Market Country ( when such NDA has been separately filed with such regulatory authorit y and not as part of the centralized approval proce dure of the EMA or the European Commission ) and necessary for t he manufacture and commercialization of a pharmaceutical, biologic or device product in such Major Market Country, and ( iv ) with reference to Ja pan, the approval of an NDA by the MHLW necessary for the ma nufacture and commercialization of a pharmaceutical, biologic or device product in Japan, including in e ach case of the preceding clauses ( i ) through ( iv ), any applicable pricing and governmental reimbursement a pprovals legally or practically required to manufac ture and commercialize such product in such country or juris diction 1.58 means any exclusive marketing rights or data prot ection or other exclusivity rights conferred by any regulatory auth ority with respect to a Licensed Product in a count ry or jurisdiction in the Territory, including but not li mited to orphan drug or pediatric exclusivity