Common use of Global Registrational Studies Clause in Contracts

Global Registrational Studies. Without prejudice to Section 3.1(c) Nanobiotix will notify Lian reasonably in advance of the initiation of a Pivotal Trial for the Licensed Product (each, a “Global Registrational Study”) and may propose to Lian to participate in any such Global Registrational Study (such notice, a “Global Registrational Study Notice”). Upon Lian’s receipt of a Global Registrational Study Notice, Lian will have the option to obtain a license and right of reference to the Global Registrational Study efficacy data and Regulatory Filings and Regulatory Approvals containing such Global Registrational Study data (the “Global Registrational Study Data”) for use in Developing and Commercializing the Licensed Products in the Field and in the Territory (the “Global Registrational Study Option”), subject to using Lian Commercially Reasonable Efforts to enroll study patients in the Territory equal to a minimum of [***] of the total study patients in such Global Registrational Study, but in any event no more than[***] patients in total per trial (the “Global Registrational Study Commitment”). Lian may exercise the Global Registrational Study Option: (i) prior to the anticipated study initiation date, in which case if Lian fails to meet the Global Registrational Study Commitment, then Lian will reimburse Nanobiotix [***]; or (ii) after the anticipated study initiation date, in which case Lian agrees to be responsible for [***] of the total costs incurred by Nanobiotix to conduct such Global Registrational Study in which Lian did not participate. The Parties shall discuss and agree in good faith any Post-Approval Commitment mandated by a Regulatory Authority upon the Regulatory Approval of the Licensed Product in the Territory, including the inclusion of such mandated Post-Approval Commitment in a Global Registrational Study. Notwithstanding anything to the contrary set forth in this Agreement, Nanobiotix shall provide to Lian at no cost the safety data resulting from any Global Registrational Study, which Lian may use as it deems required.

Appears in 4 contracts

Samples: License, Development and Commercialization Agreement (Nanobiotix S.A.), License, Development and Commercialization Agreement (Nanobiotix S.A.), License, Development and Commercialization Agreement (LianBio)

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