Regulatory Exclusivity

Regulatory Exclusivity. Means market exclusivity granted by a Governmental Authority designed to prevent the entry of generic product(s) onto the market, including without limitation new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity and 180-day generic product exclusivity, or any equivalent of the foregoing in any country in the world

Regulatory Exclusivity. With respect to any country or other jurisdiction, 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 Surface or its Affiliates or Licensees have an exclusive right to market and sell a Product in such country or other jurisdiction through a regulatory exclusivity right (including regulatory data exclusivity).

Regulatory Exclusivity. With respect to a Product, any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to such Product, other than patent rights, that prohibits a third party from (a) relying on data generated by or on behalf of the Parties with respect to such Product in an application for regulatory approval, or (b) commercializing such Product (for example, any Data Exclusivity rules released by the CFDA).