definiens: means any rights or protections which are recognized, afforded or grantedby a Regulatory Authority in any Country or region of the Territory, in association with the Regulatory Approval of aLicensed Product, providing such Licensed Product : ( a ) a period of marketing exclusivity, during which the RegulatoryAuthority recognizing, affording or granting such marketing exclusivity will refrain from either reviewing or approving amarketing authorization application or similar regulatory submission, submitted by a Person other than Chiesi, itsAffiliates or its Sublicensees seeking to market a drug product in which the Drug Substance is the primary ingredient, or during which such an application or submission may be reviewed or approved by a Regulatory Authority, but theproduct may not be placed on the market or ( b ) a period of data exclusivity, during which a Person, other than Chiesi, its Affiliates or its Sublicensees, seeking to market a drug product in which the Drug Substance is the primaryingredient, is precluded from either referencing or relying upon a Licensed Product ’s clinical dossier or relying onprevious findings of safety or effectiveness with respect to a Licensed Product to support the submission, review orapproval of a marketing authorization application or similar regulatory submission before the applicable RegulatoryAuthority . Regulatory Exclusivity shall include rights conferred in the European Union / European Economic Areapursuant to Section 10.1 of Directive 2001 / EC/83 or section 14.11 of Regulation ( EC ) No . 726/2004