definiens: means any right s or protections which are recognized, afforded or granted by a Regulatory Authority in any Country or region of the Territory, in association with the R egulatory Approval of a Licensed Product, providing such Lice nsed Product : ( a ) a period of marketing exclusivity, during which the Regulatory Authority recognizing, affordi ng or granting such marketing exclusivity will refr ain from either reviewing or approving a marketing authoriza tion application or similar regulatory submission, submitted by a party other than [COMPANY], its Affiliates or Sub licensees seeking to market a drug product in which the Drug Substance is the primary ingredient, or during whic h such an application or submission may be reviewed or approved by a Regulatory Authority, but the product may not be placed on the market or ( b ) a period of data exclusivity, during which a party, other than Pfize r, its Affiliates or Sublicensees, seeking to marke t a drug product in which the Drug Substance is the primary ingredient, is precluded from either referencing or relying upon a Licensed Product ’s clinical dossier or relyi ng on previous findings of safety or effectiveness with respect to a Licensed Product to support the submission, re view or approval of a marketing authorization appli cation or similar regulatory submission before the applicable Regulatory Authority . Regulatory Exclusivity shall include rights conferred in the United States pursuant to t he Hatch - Waxman Act or the FDA Modernization Act of 1997 or in the European Union / European Economic Area pur suant to Section 10.1 of Directive 2001 / EC/83 or se ction 14.11 of Regulation ( EC ) No . 726/2004