definiens: means any applicable government regulatory author ity involved in granting approvals for the conduct of clinical tria ls or the manufacturing, marketing, reimbursement o r pricing, as applicable, of the Product, including in the United States, the FDA and in the European Union, the EMA, and in the United Kingdom, the MHRA, and any successor gov ernmental authority having substantially the same function . 1.112 means, with respect to the Product in a country i n the [COMPANY] Territory, that ( a ) [COMPANY] or any of its Affiliate s or Sublicensees has been granted the exclusive le gal right by a Regulatory Authority ( or is otherwise entitled to t he exclusive legal right by operation of Applicable Laws and Regulations ) in such country to market and sell the Product or the active ingredient comprising the Pr oduct in such country, or ( b ) the data and information submitted by [COMPANY] or any of its Affiliates or Sublicensees to the relevant Regulatory Authority in such country for purposes o f obtaining Regulatory Approval may not be disclose d, referenced or relied upon in any way by such Regula tory Authority ( including by relying upon the Regul atory Authority ’s previous findings regarding the safety or effectiveness of the Product ) to support the Reg ulatory Approval or marketing of any product by a Third Par ty in such country