definiens: as that term is defined in 21 C.F.R. § 314.3(b ), or an equivalent non - exclusiveright of access / reference in the United States and in the EU and in each other Country in the Territory ( A ) solely foruse by [COMPANY] in connection with the Development and/or Commercialization of any Licensed Product outside of theTerritory or any New Use ( or other drug product containing the Drug Substance outside of the Field ), to any data inany regulatory filing in the EU or any other Country in the Territory Controlled by Chiesi that relates to the DrugSubstance or Licensed Product, and ( B ) solely for use by [COMPANY] in connection with the Development of drugproducts made using the System, to any safety data ( but not efficacy data ) in any regulatory filing in the EU or anyother Country in the Territory Controlled by Chiesi that relates to the Drug Substance or Licensed Product . Chiesi shallprovide a signed statement to this effect, if requested by [COMPANY], in accordance with 21 C.F.R. § 314.50(g)(3 ) or theequivalent as required in the EU or any other Country in the Territory, or otherwise provide appropriate notification ofsuch right of [COMPANY] to the applicable Regulatory Authority . To the extent Chiesi shall need an equivalent as that term is defined in 21 C.F.R. § 314.3(b ), to exploit the rights granted hereunder in the Territory, [COMPANY] shall ( and does hereby ) grant to Chiesi a non - exclusive Right of Reference, or an equivalent non - exclusiveright of access / reference in the United States and in the EU and in each other Country in the Territory, solely for useby Chiesi in connection with the Development and/or Commercialization of the Licensed Product in the Field in theTerritory, and solely if and to the extent that Chiesi is authorized under this Agreement to conduct such Developmentand / or Commercialization, ( A ) to any data in any regulatory filing Controlled by [COMPANY] that relates to the DrugSubstance or Licensed Product, and ( B ) to any safety data ( but not efficacy data ) in any regulatory filing that relatesto the Drug Substance or Licensed Product . [COMPANY] shall provide a signed statement to this effect, if requested byChiesi, in accordance with 21 C.F.R. § 314.50(g)(3 ) or the equivalent as required in the EU or any other Country in theTerritory, or otherwise provide appropriate notification of such right of Chiesi to the applicable Regulatory Authority