definiens: as that term isdefined in 21 C.F.R. § 314.3(b ) in the United States, or an equivalent exclusive right of access / refere nce in any othercountry or region of the Territory, to any Data inc luded in a Regulatory Filing or filing for Pricing and ReimbursementApproval for a Product for use by the other Party t o Develop and Commercialize the Products in the Fie ld pursuant tothis Agreement . Each Party or such Affiliate shall provide a signed statement to this effect, if reque sted by the otherParty, in accordance with 21 C.F.R. § 314.50(g)(3 ) o r the equivalent as required in any country or regi on of theTerritory, or otherwise provide appropriate notific ation of such right of the other Party to the appli cable RegulatoryAuthority