definiens: . Regulatory Exclusivity means any rights or protections which arerecognized, afforded or granted by any Regulatory Authority in any country or region of the Licensed Territory inassociation with obtaining Marketing Authorization for the Licensed Product, providing such Licensed Product : ( a ) aperiod of marketing exclusivity during which the applicable Regulatory Authority shall refrain from either reviewing orapproving a Marketing Authorization application or similar regulatory submission submitted by a Third Party seeking tomarket a competing product, or ( b ) a period of data exclusivity during which a Third Party seeking to market acompeting product and/or the Regulatory Authority responsible for granting Marketing Authorization therefor isprecluded from either referencing or relying upon, without an express right of reference from the dossier holder, suchLicensed Product ’s clinical dossier or relying on previous Regulatory Authority findings of safety or effectiveness withrespect to such Licensed Product to support the submission, review or approval of a Marketing Authorizationapplication or similar regulatory submission before the applicable Regulatory Authority . Regulatory Exclusivity shallinclude rights conferred in the EU pursuant to Section 10.1(a)(iii ) of Directive 2001 / EC/83