definiens: as that term is defined in United States 21 C.F.R. § 314.3(b ) in the United States, or an equivalent right ofaccess / reference in any other country or region, to any Data, including such Party ’s or its Affiliate ’s clinical dossiers, Controlled by such Partyor such Affiliate that relates to the Product for use by Partner to Commercialize the Product in the Field in the Partner Territory pursuant to thisAgreement or by [COMPANY] to Develop or Commercialize the Product in the [COMPANY] Territory . Each Party or such Affiliate(s ) thereof shallprovide a signed statement to this effect, if requested by the other Party, in accordance with United States 21 C.F.R. § 314.50(g)(3 ) or itsequivalent as required in any other country or region or otherwise provide appropriate notification of such right of the other Party to theapplicable Regulatory Authority in the Partner Territory or the [COMPANY] Territory, as the case may be