Licensee Grant of Right of Reference. Licensee hereby grants to Axsome a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any analogous Applicable Law recognized outside of the United States), to all regulatory filings made by or on behalf of, or otherwise owned or Controlled by or on behalf of, Licensee
Axsome Grant of Right of Reference. Axsome hereby grants to Licensee a “Right of Reference,” defined substantially similarly as that term is defined in 21 C.F.R. § 314.3(b) (or any analogous Applicable Law recognized outside of the United States), to all regulatory filings Controlled by Axsome, its Affiliates or any of its or their sublicensees that relates to any Licensed Product to enable Licensee to conduct, to the extent permitted under Section 3.3, Development activities with respect to the Licensed Products and for use by Licensee in connection with the filing and maintenance of Regulatory Approvals or applications for Regulatory Approvals, in each case, solely for the Licensed Products in the Territory, and Axsome shall and shall cause such Affiliates or sublicensees, as applicable, to provide a signed statement to this effect, if requested by Licensee, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Applicable Law recognized outside of the United States).
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