definiens: means any rights or protections which are recognized, afforded or granted by 4!iy Regulatory Authority in any country or region in association with the Regfilatory Approval of a Collaboration Product, providing such Collaboration p{dduct a period of marketing exclusivity during which a Regulatory Auth9ric;;'that recognizes, affords or grants such marketing exclusivity shall refrail1frQnl either reviewing or approving a marketing authorization applicatiofvor similar Regulatory Submission submitted by a Third Party seeking to market a generic product . Regulatory Exclusivity shall include rights conferred in the United States pursuant to the Hatch - Waxman Amendments to the FD&C Act, the Orphan Drug Act or the Best Pharmaceuticals for Children Act or in the European Union pursuant to Section 1O.1(a)(iii ) of Directive 2001 / EC/83