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 t he Field pursuant to this Agreement . To the extent permitted by applicable law, each Party shal l 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 - 19 - Confidential notification of such right of the other Party to th e applicable Regulatory Authority and, subject to Section 7.1.3 shall use Commercially Reasonable Eff orts to cause its Related Party to provide such signed statement . Each Party will provide, and shal l use Commercially Reasonable Efforts to cause its Related Party to provide, cooperation to the ot her Party to effect the foregoing