definiens: means any rights or protections which are recognized, afforded or granted by a RegulatoryAuthority in any Country or region of the Territory, in association with the Regulatory Approval of a Licensed Product, providing such Licensed Product : ( a ) a period of marketing exclusivity, during which the Regulatory Authority recognizing, affording or granting such marketing exclusivity will refrain from either reviewing or approving a marketing authorizationapplication or similar regulatory submission, submitted by a party other than [COMPANY], its Affiliates or Sublicensees seeking tomarket a drug product in which the Drug Substance is the primary ingredient, or during which such an application orsubmission may be reviewed or approved by a Regulatory Authority, but the product may not be placed on the market or ( b ) aperiod of data exclusivity, during which a party, other than [COMPANY], its Affiliates or Sublicensees, seeking to market a drugproduct in which the Drug Substance is the primary ingredient, is precluded from either referencing or relying upon a LicensedProduct ’s clinical dossier or relying on previous findings of safety or effectiveness with respect to a Licensed Product tosupport the submission, review or approval of a marketing authorization application or similar regulatory submission beforethe applicable Regulatory Authority . Regulatory Exclusivity shall include rights conferred in the United States pursuant to theHatch - Waxman Act or the FDA Modernization Act of 1997 or in the European Union / European Economic Area pursuant toSection 10.1 of Directive 2001 / EC/83 or section 14.11 of Regulation ( EC ) No . 726/2004