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 in any other countr y or region, with respect to : ( i ) Zai ’s and any [ * * * ] 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 ) ), ( x ) associated with the Licensed Compound or Product in the Field and ( y ) for the sole purpose of Developing, Manufacturing, seeking and securing Regulatory Approval for, Commercializing, and otherwise exploiting Products outside of the Territory . For clarity ( 1 ) Taiho shall have the right to extend the foregoing Right of Reference and right of access to Associated Parties, and ( 2 ) the foregoing right of access shall also include the right of Taiho ( and Associated Parties ) to include the accessed Regulatory Data in its Regulatory Filings for Product . Upon request by Taiho, Zai ( or the a pplicable Related Party ) shall provide Taiho with a signed statement affirming the foregoing Right of Reference in accordance with 21 C.F.R