definiens: means any exclusive marketing rights or data prot ection or other non - patent exclusivity rights conferred by any Regulato ry Authority with respect to a Licensed Product in a country or jurisdiction in the Territory, including orphan drug exclusivity, pediatric exclusivity, data and m arket exclusivity rights conferred under the ACA, includi ng the Biologics Price Competition and Innovation A ct, or in the European Union under Directive 2001/83 / EC, as a mended, and Regulation ( EC ) No . 1901/2006, as amend ed, or rights similar thereto in other countries or reg ulatory jurisdictions in the Territory, that preven t such Regulatory Authority from granting any regulatory a pproval under the Biologics Price Competition and Innovation Act or similar applicable Law, of a Thir d Party product ( the ) ; provided, however, that, in the event that a Regulatory Autho rity confers more than one type of exclusivity with respect to a Licensed Product in a country or jurisdiction ( e. g., the FDA grants both Biologic Exclusivity and pe diatric exclusivity with respect to such Licensed Product ), will be deemed to apply t o such Licensed Product in such country so long as any Reg ulatory Exclusivity granted to such Licensed Produc t prevents such Regulatory Authority from granting an y regulatory approval under the Biologics Price Competition and Innovation Act, or similar applicab le Law, of a Third Party product that has an amino acid sequence that is the same as or highly similar to t he amino acid sequence of such Licensed Product . Re gulatory Exclusivity shall not include exclusivity conferred by a Patent Right