definiens: means any rights or protections which are recognized, afforded orgranted by the FDA, EMEA or any other Regulatory Authority in any country or region of the Territory, inassociation with the Regulatory Approval of a Product, providing such Product : ( a ) a period of marketingexclusivity, during which a Regulatory Authority recognizing, affording or granting such marketingexclusivity shall refrain from either reviewing or approving a marketing authorization application or similarregulatory submission, submitted by a Third Party seeking to market a Competing Product, or ( b ) a periodof data exclusivity, during which a Third Party seeking to market a Competing Product is precluded fromeither referencing or relying upon, without an express right of reference from the dossier holder, suchProduct 's clinical dossier or relying on previous Regulatory Authority findings of safety or effectivenesswith respect to such Product to support the submission, review or approval of a marketing authorizationapplication or similar regulatory submission before the applicable Regulatory Authority