definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any successor rule or analogous Law re cognized outside of the United States ), to, and a r ight to copy, access, and otherwise use, all information an d data ( including all chemistry, manufacturing and controls information as well as data made, collected or othe rwise generated in the conduct of any clinical stud ies for Licensed Products ) included in or used in support o f any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation ( including orphan drug applications and designations ) owned or contr olled by such Party, and such Party shall provide a signed s tatement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3 ) ( or any su ccessor or analogous Law outside of the United Stat es ) . In addition, upon request of either Party ( on behalf o f itself or a Sublicensee ), the other Party shall o btain and provide to the requesting Party certificates or oth er formal or official attestations concerning the r egulatory status of the Licensed Products ( e.g., Certificates of Free Sale, Certificates for Expor t, Certificates to Foreign Governments ) . Notwithstanding anything to the contr ary in this Agreement, neither Party shall withdraw or inactivate any regulatory filing that the other Par ty references or otherwise uses pursuant to this Se ction 4.2 4.3 . Communications with Authorities