definiens: means any entity auth orized by [COMPANY], its Affiliates or Sub - Licensees, that under validly exe cuted agreements, which are commensurate, as appropriate, with the terms and co nditions recited herein, that shall be authorized only to distribute in the Terri tory the Finished Products as a result of a Sale to Customers . [COMPANY], on an an nual basis on each anniversary of the Effective Date, shall provide Re geneRx a list of all Distributors 1.7 means any and all p roprietary and confidential reports, Specifications, registration material and dossiers resulting from clinical trials, including associated patient histo ry ( where permitted and in compliance with all local country disclosure laws ), toxicological data, any and all technical data, notices, pre - clinical data, cli nical data, CMC ( chemistry, manufacturing, control data ), pharmacokinetic and p harmacological test and analytical data and any orphan drug submissions, ap plications or designations, and any other embodiment of technical information, whether in electronic or tangible form, related to or associated with Defian te Improvements, Joint Improvements, RegeneRx Improvements, Bulk Active Ma terial or Finished Products