definiens: shall mean a right or protection, granted by a Regulatory Authority in a jurisdiction(including the United States and any European country ) in the Territory, providing, with respect to a Licensed Productin the Field : ( i ) marketing exclusivity that prevents the Regulatory Authority from accepting a Drug ApprovalApplication ( whether new or abbreviated ) submitted by a Third Party for a generic or biosimilar version of apharmaceutical product that is the same as or a bioequivalent of the Licensed Product, including but not limited toexclusivity achieved through new molecular entity, orphan drug, or pediatric drug exclusivity designation by the FDAor any other national, supra - national ( e.g., the European Commission, the Council of the European Union, or EMA),regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity ; or(ii ) data protection for regulatory data submitted with respect to a Licensed Product, including but not limited toprotection against unfair commercial use or public release consistent with, or no less stringent than, TRIPS Article39.3