definiens: means the period of data exclusivity for a Product in a country that is grantedwhen such Product first receives Product Regulatory Approval based on such Product ’s status as a new chemicalentity ( and not based on a use or application of such Product, such as, for example, orphan drug exclusivity ( unless aProduct is only approved for 22orphan indications ), new uses or pediatric exclusivity ) that is, with respect to the United States, listed in the FDA’sOrange Book or outside the United States, under the national implementations of Article 10.1(a)(iii ) of Directive2001 / EC/83 or other international equivalents . If during the Data Exclusivity Period with respect to a Product in acountry, a generic version of such Product ( or, with respect to orphan exclusivity, a product for use in the sameindication ) is approved by the applicable Regulatory Authority(ies ) for sale in such country, then, notwithstanding thepreceding sentence, the Data Exclusivity Period shall be deemed to have expired with respect to such Product insuch country