definiens: shall mean, on a country -by - country and Product -by - Product basis, an additional protection, other than patent protection, granted by a Regulatory Authority that confers an exclusive period during which a Party or its Affiliates or Sublicensee s have the exclusive right to market or sell a Product in such country through a regulatory exclusivity right ( e.g., new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data excl usivity ), provided that regulatory exclusivity shall only be deemed to exist in a country if ( i ) Applicable Laws, and the guidance, policies and practice of the competent Regulatory Authority allow other mRNA -Based products to qualify as generic or biosimi lar versions of a Product ; and ( ii ) as a result, absent or after the expiry of the regulatory exclusivity right, such mRNA -Based products can enter the market of the country in question with substantially lower development investment