Examples of Registrational Study in a sentence
Notwithstanding the foregoing described exclusivity, from and after the initiation of a Registrational Study with respect to a given Product Candidate or Elected Candidate, Merck and/or its Third Party Manufacturer can Manufacture, and Merck may purchase, cGMP Moderna mRNA API for each such Product Candidate or Elected Candidate, in accordance with Section 4.3; provided, that, [***].
In the event that Lian intends to conduct a Pivotal Trial for the Licensed Product in the Field in the Territory (each, a “Local Registrational Study”), Lian will notify Nanobiotix reasonably in advance of the initiation of such Local Registrational Study and provide Nanobiotix with the study design, study protocol, study budget, and anticipated study initiation date (such notice, a “Local Registrational Study Notice”).
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”).
Before the Commencement of the first Registrational Study for any Collaboration Product following the exercise of the Merck Participation Election for the applicable Program, Merck shall provide, and within [***] days after such provision the JCC will review and update for approval by the JSC, a written summary of the global Commercialization strategy for all Collaboration Products included in the Joint Development Plan and Budget for the applicable Program in the Territory.
Each Party shall have the right to Opt-Out of any proposed new Clinical Study (including a Registrational Study) or Post Approval Study that is not contemplated in the Development Plan as of the Effective Date, subject to the provisions of Sections 2.6.1(b) and 2.6.2(b).