Regulatory Exclusivity Right definition
Regulatory Exclusivity Right means a right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a product in such jurisdiction: (a) marketing exclusivity that prevents the Regulatory Authority from accepting or approving a Drug Application (whether new or abbreviated), submitted by a Person other than ▇▇▇▇▇▇▇ (or any of its Affiliates or Third Party sublicensees), such as through new molecular entity or orphan drug exclusivity granted by the FDA, or an exclusive right to sell pursuant to the data exclusivity provisions under EC Directives 2004/27/EC and 2001/83/EC and Regulation 726/2004/EC, or marketing exclusivity granted in respect of pediatric studies under Regulation 1901/2006, or Section 505A(a) of the FD&C Act; or (b) data protection for regulatory data submitted by or on behalf of a Party or its Affiliates relating to a product against unfair commercial use or public release consistent with, or no less stringent than, TRIPs Article 39.3.
Regulatory Exclusivity Right means a right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a product in such jurisdiction: (a) marketing exclusivity that prevents the Regulatory Authority from accepting or approving a Drug Application (whether new or abbreviated), submitted by a Person other than Janssen (or any of its Affiliates or Third Party sublicensees), such as through new molecular entity or orphan drug exclusivity granted by the FDA, or an exclusive right to sell pursuant to the data exclusivity provisions under EC Directives 2004/27/EC and 2001/83/EC and Regulation 726/2004/EC, or marketing exclusivity granted in respect of pediatric studies under Regulation 1901/2006, or Section 505A(a) of the FD&C Act; or (b) data protection for regulatory data submitted by or on behalf of a Party or its Affiliates relating to a product against unfair commercial use or public release consistent with, or no less stringent than, TRIPs Article 39.3.
Regulatory Exclusivity Right means a right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a product in such jurisdiction marketing or data exclusivity that prevents the Regulatory Authority from accepting or approving a Drug Application (whether new or abbreviated), submitted by a Person other than GSK (or any of its Affiliates or Sublicensees), such as through new molecular entity, new use or indication exclusivity, new formulation exclusivity, non-patent related pediatric exclusivity or orphan drug exclusivity granted by the FDA, or an exclusive right to sell pursuant to the data exclusivity provisions under EC Directives 2004/27/EC and 2001/83/EC and Regulation 726/2004/EC, or marketing exclusivity granted in respect of pediatric studies under Regulation 1901/2006, or Section 505A(a) of the FD&C Act. 1.176 “Regulatory Filing” means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to a Licensed Product, or its use or potential or investigative use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs, supportive documents enabling a clinical program, Drug Applications, safety and adverse event reports and all correspondence with any Regulatory Authority with respect to any Licensed Product
More Definitions of Regulatory Exclusivity Right
Regulatory Exclusivity Right means a right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a Licensed Product in such jurisdiction: (a) marketing exclusivity that prevents the Regulatory Authority from accepting or approving a Drug Application (whether new or abbreviated), submitted by a party other than ▇▇▇▇▇▇▇ (or any of its Affiliates or Third Party sublicensees), for a generic or competing version of a pharmaceutical product comprising a compound that is a Bioequivalent to the Active Substance in the Licensed Product, such as through new molecular entity or orphan drug exclusivity granted by the FDA, or an exclusive right to sell pursuant to the data exclusivity provisions under EC Directives 2004/27/EC and 2001/83/EC and Regulation 726/2004/EC, or marketing exclusivity granted in respect of pediatric studies under Regulation 1901/2006, or Section 505A(a) of the FDC Act; or (b) data protection for regulatory data submitted by ▇▇▇▇▇▇▇ relating to the Licensed Product against unfair commercial use or public release consistent with, or no less stringent than, TRIPs Article 39.3.
Regulatory Exclusivity Right means a right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a Licensed Product in such jurisdiction: (a) marketing exclusivity or data exclusivity that prevents the Regulatory Authority from accepting or approving a Drug Application (whether new or abbreviated), submitted by a Person other than Janssen (or any of its Affiliates or Third Party sublicensees), for a generic or
Regulatory Exclusivity Right means a right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a Licensed Product in such jurisdiction: (a) marketing exclusivity or data exclusivity that prevents the Regulatory Authority from accepting or approving a Drug Application (whether new or abbreviated), submitted by a Person other than ▇▇▇▇▇▇▇ (or any of its Affiliates or Third Party sublicensees), for a generic or competing version of a pharmaceutical product comprising a compound that is a Bioequivalent to any Achillion Single API in the Licensed Product, such as through new molecular entity or orphan drug exclusivity granted by the FDA, or an exclusive right to sell pursuant to the data exclusivity provisions under EC Directives 2004/27/EC and 2001/83/EC and Regulation 726/2004/EC, or marketing exclusivity granted in respect of pediatric studies under Regulation 1901/2006, or Section 505A(a) of the FDC Act; or (b) data protection for regulatory data submitted by or on behalf of a Party or its Affiliates relating to the Licensed Product against unfair commercial use or public release consistent with, or no less stringent than, TRIPs Article 39.3.