Definition of Non Infectious Uveitis Pivotal Trial


Non Infectious Uveitis Pivotal Trial means an adequate and well-controlled study (as defined in 21 CFR SS 314.126) or foreign equivalent thereof to be conducted with the Product for use in the treatment of Non Infectious Uveitis, as further detailed in the Behcet's Uveitis and Non Infectious Uveitis Development Plan.
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Examples of Non Infectious Uveitis Pivotal Trial in a sentence

An initial Global Research and Development Plan for Non Infectious Uveitis, which contains the initial design of a Non Infectious Uveitis Pivotal Trial and the preliminary Development Budget for continued Development of the Product for Non Infectious Uveitis will be attached to this Agreement as Exhibit 3.3(b) (the "Initial Non Infectious Uveitis Development Plan").
The Behcet's Pivotal Trial will be conducted by Servier acting as the sponsor in the Licensed Territory and Japan, and a separate Non Infectious Uveitis Pivotal Trial will be conducted by XOMA acting as the sponsor in the Retained Territory and some countries of the Licensed Territory indicated by Servier in writing in its sole discretion.