“Regulatory Exclusivity” means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which [[Organization A:Organization]] or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity).

“Regulatory Exclusivity” means,means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to anya Licensed Product in a country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confersPatent, including exclusivity for an exclusive Commercialization period during which [[Organization A:Organization]] or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g.,approved Drug Approval Application, new chemical entity exclusivity, new use or indication exclusivity, new formulationclinical data exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity).rights similar thereto in other countries or regulatory jurisdictions.

“Regulatory Exclusivity” means,“Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to anya Licensed Product in a country or other jurisdiction in the Territory, an additional market protection, other than a Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which [[Organization A:Organization]] or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity,Right, including orphan drug exclusivity, pediatric exclusivity, rights conferred in the European Union under Directive 2001/EC/83, or rights similar thereto in any applicable data exclusivity).country or jurisdiction in the Territory.

“Regulatory Exclusivity” means,means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to any country ora Product other jurisdictionthan Patents, including, without limitation, rights conferred in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such countryUnited States under Biologics Price Competition and Innovation Act, or other jurisdiction which confers an exclusive Commercialization period during which [[Organization A:Organization]] or its Affiliates or Sublicensees haverights similar thereto outside the exclusive right to market and sell a Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity).United States.

“Regulatory Exclusivity” means, with respect toExclusivity Period” means any period of data, market or other regulatory exclusivity (as distinct from and excluding any exclusivity arising under Patent Rights) for a Product in a country or other jurisdictionregion in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory AuthorityTerritory under applicable laws, rules and regulations in such country or other jurisdictionregion which confers an exclusive Commercialization period during which [[Organization A:Organization]]prevents any unlicensed Third Party from marketing, promoting or its Affiliates or Sublicensees have the exclusive right to market and sellselling a LicensedGeneric Product in such country or other jurisdiction through a regulatoryregion, including, without limitation, any such exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity,provided in countries in the EU under national laws and regulations implementation [Section 10.1(a)(iii)] of Directive 2001/EC/83 or any applicable data exclusivity).analogous laws or regulations in other countries in the Territory.