definiens: means any rights or protections which are recognized, afforded or granted by any Regulatory Authority in any country or region of theTerritory in association with the Regulatory Approval of a Licensed Product in theField, providing such Licensed Product : ( i ) a period of marketing exclusivity duringwhich a Regulatory Authority that recognizes, affords or grants such marketingexclusivity shall refrain from either reviewing or approving a marketingauthorization application or similar regulatory submission submitted by a ThirdParty seeking to market a product containing the same active pharmaceuticalingredient as such Licensed Product ; or ( ii ) a period of data exclusivity duringwhich a Third Party seeking to market a product containing the same activepharmaceutical ingredient as such Licensed Product is precluded from eitherreferencing or relying upon, without an express right of reference from the dossierholder, such Licensed Product ’s clinical dossier or relying on previous RegulatoryAuthority findings of safety or effectiveness with respect to such Licensed Productto support the submission, review or approval of a marketing authorizationapplication or similar regulatory submission before the applicable RegulatoryAuthority