definiens: as that term is defined in 21 C.F.R. § 314.3(b ) in the United States, or an equivalent right of access / reference i n any other country or region, with respect to : ( i ) Licensor ’s and Associated Parties ’ Regulatory Filings and Regulatory Approvals and all related documentation ( including official minutes of meetings and other correspondence related thereto ), and ( ii ) all Regulatory Data relating to such Regulatory Filings and Regulatory Approvals in ( i ) above ( including safety data and CMC data contained or referenced in any Regulatory Filings ), in each case ( ( i ) and ( ii ) ), ( A ) associated with the Licensed Compound or Lic ensed Product in the Field and ( B ) for the sole purpose of Developing, Manufacturing, seeking and securing Regulatory Approval for, Commercializing, and otherwise exploiting Licensed Products in the Field in the Territory . For clarity ( 1 ) Licensee shall ha ve the right to extend the foregoing Right of Reference and right of access to its Affiliates and Sublicensees, and ( 2 ) the foregoing right of access shall also include the right of Licensee ( and its Affiliates and Sublicensees ) to include the accessed Regulatory Data in its Regulatory Filings for Licensed Product . Upon request by Licensee, Licensor ( or its Associated Party, as applicable ) shall provide Licensee with a signed statement affirming the foregoing Right of Reference in accordance with 21 C.F.R. § 314.50(g)(3 ) or the equivalent as required in any country or region, or otherwise provide appropriate notification of such right of Licensee to the applicable Regulatory Authority