RE:RE:RE:Accelerated Approval, surrogate endpoints, registration An example of the use of Registered Enabling Trial as defined in the Licensing Agreement between “AstraZeneca” and Sierra Oncology, Inc
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1.96. “Registration Enabling Trial”, means, with respect to a Licensed Product, a human clinical study (whetheror not designated a
Phase 3 Clinical Study), the results of which, together with prior data and information concerning
such LicensedProduct, [***] of an effectiveness claim in support of the initial approval of an NDA for such intendeduse of such Licensed Product.A Registration Enabling Trial includes a Phase 3 Clinical Study. If a human clinical study is denominated not a Phase 3 Clinical Study (for example, human clinical studies formally registered as Phase 2 clinical studies) then it shall only be treated as a Registration Enabling Trial hereunder if and when [***]
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