definiens: as that term is defined in 21 C.F.R. § 314.3(b ) in the United States, or an equi valent right of access / reference in any other country or region, to any data, including such Party ’s or its Related Pa rty ’s clinical dossiers, Controlled by such Party or such Related Party that relates to the Product for use by the ot her Party to Develop and Commercialize the Product in the Field pursuant to this Agreement . For clarity, AMAG may u se such Right of Reference to Develop and Commercialize the Product in the AMAG Territory and [COMPANY] may use such Right of Reference to Develop and Commercialize the Product in the [COMPANY] Territory . Each Party shall 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 provide appropriate notification of s uch right of the other Party to the applicable Regulatory Author ity and shall cause its Related Party to provide su ch signed statement . Each Party will provide, and will use re asonable efforts to cause its Related Party to prov ide cooperation to the other Party to effect the foregoing