Registrational Trial definition
Registrational Trial means, with respect to a given Product, either: (a) a Phase III Clinical Trial with such Product; or (b) a Phase IIb Clinical Trial that, at the time of commencement, is expected to be the basis for initial Regulatory Approval of such Product.
Registrational Trial means a clinical trial of a Company Product that satisfies either of the following ((a) or (b)):
Registrational Trial means any (a) a Phase 3 Clinical Trial, or (b) other Clinical Trial (or arm thereof) of a pharmaceutical or biologic product, the results of which, together with prior data and information concerning such product, are intended to be or otherwise are sufficient, without any additional Clinical Trial, to meet the evidentiary standard for demonstrating the safety, purity, efficacy, and potency of the active substance of such product established by a Regulatory Authority in any particular jurisdiction and is intended to support, or otherwise supports, the filing of an MAA in such jurisdiction (including any bridging study meeting the foregoing requirements).
Examples of Registrational Trial in a sentence
For clarity, in no event shall any Milestone Payment be made more than once and in no event shall any Milestone Payment be made for more than one Product; provided that, for the avoidance of doubt, in no event shall Incyte pay more than $175,000,000 in the aggregate for achievement of the Registrational Trial Milestones or more than $500,000,000 in the aggregate for achievement of the U.S. Approval Milestones.
If [***] subsequently achieves the Registrational Trial Milestone, then [***] shall be deemed achieved and Incyte shall, subject to the terms of this Section 2.6, pay or cause to be paid to Prelude the Milestone Payment corresponding to [***].
More Definitions of Registrational Trial
Registrational Trial means: (a) any Clinical Trial that is intended by Licensor, its Affiliate, or a Subsequent Licensee to be submitted for Regulatory Approval in the Territory; or (b) any Clinical Trial based on an agreement or other statement or guidance from the Regulatory Authority in such country that such Clinical Trial is designed to provide data on which a Regulatory Approval will be principally based.
Registrational Trial means either:
Registrational Trial means, with respect to a given Product, either (i) a Phase III Clinical Trial with such Product or (ii) a Phase IIb Clinical Trial that, at the time of commencement, is expected to be the basis for initial Regulatory Approval of such Product.
Registrational Trial means a Clinical Trial of a Licensed Product that is designed (at the time the Clinical Trial is Initiated) to obtain (as reasonably determined by BMS) results and data sufficient to support the filing of a Drug Approval Application and identified by BMS as a pivotal registration study in its development plans.
Registrational Trial means, with respect to a product, a human clinical trial (regardless of whether such clinical trial is referred to as a “Phase II Clinical Trial”, “Phase IIb Clinical Trial”, “Phase II/III Clinical Trial”, “Phase IIb/III Clinical Trial” or “Phase III Clinical Trial”) for such product, the results of which, together with prior information concerning such product, are determined by the sponsor to be intended to be sufficient to establish that such product is safe and effective for its intended Indication to support the filing of an MAA. [***]
Registrational Trial means a Clinical Trial that is designed to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals). A Registrational Trial includes any Clinical Trial that satisfies at least one of the following criteria:
Registrational Trial means the earlier to occur of: (a) a Phase III Clinical Trial or (b) any other Clinical Trial of a Licensed Product for which the applicable Regulatory Authority has agreed in writing, whether before Initiation of such Clinical Trial (e.g., pursuant to a written agreement with or written statement from the FDA or the EMA on a ‘Special Protocol Assessment’ or equivalent or other written minutes issued by the FDA or EMA) or after Initiation of such Clinical Trial (e.g., based on an interim data analysis), is sufficient to form the primary basis for Regulatory Approval. If a Clinical Trial is determined in writing by the applicable Regulatory Authority, after review of the efficacy and safety data from a Phase II Clinical Trial for the Licensed Product, to be sufficient to form the primary basis for Regulatory Approval (i.e. Clinical Trial constitutes a Registrational Trial) without the need for a Phase III Clinical Trial(s) prior to submission, then, for purposes of the Development and Regulatory Milestone Payment, the Initiation of such Registrational Trial will be deemed to occur on the date of such written determination by the applicable Regulatory Authority.