definiens: means, with respect to each Licensed Product in anycountry in the Territory, a period of exclusivity ( other than Patent exclusivity ) granted or afforded by Applicable Law orby a Regulatory Authority in such country that confers exclusive marketing rights with respect to such LicensedProduct in such country, such as new chemical entity exclusivity, new use or Indication exclusivity, new formulationexclusivity, orphan drug exclusivity, non - patent related pediatric exclusivity or any other applicable marketing or dataexclusivity, including any such periods listed in the FDA ’s Orange Book or any such periods under nationalimplementations in the EU of Article 10 of Directive 2001/83 / ED, Article 14(11 ) of Parliament and Council Regulation(EC ) No . 726/2004, Parliament and Council Regulation ( ED ) No . 141/2000 on orphan medicines, Parliament andCouncil Regulation ( ED ) No . 1901/2006 on medicinal products for pediatric use and all international equivalents of anyof the foregoing