definiens: as that term is defined in 21 C.F.R. § 314.3(b ) in the United States, or an equivalent rig ht of access / reference in any other country or region, to any Data, including such Party ’s or its Related Party ’s clinical dossiers, Controlled by such Party or such Related Party that relates to th e Licensed Product for use by the other Party to Develop and Commercialize the Licensed Product in - 20 - Confidential the Field pursuant to this Agreement . Each Party sh all provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3 ) or the equivalent as required in any country or region or otherwise prov ide appropriate notification of such right of the other Party to the applicable Regulatory Authority and shall cause its Related Party to provide such signed statement . Each Party will provide, and will cause its Related Party to provide, cooperation to the other Party to effect the foregoing