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 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 either:

Examples of Registrational Trial in a sentence

• For Products on which BMS has not initiated a Registrational Trial prior to termination, the license described in this Section 11.6(b) shall be fully-paid and royalty-free.

• For Products on which BMS has initiated a Registrational Trial but which has not received Regulatory Approval prior to termination and that are covered by a Valid Claim of a PDL Licensed Patent or BMS Licensed Patent that, in either case, covers the Product or the manufacture, use or sale of such Product, the license described in this Section 11.6(b) shall bear a royalty of [****]* of PDL’s Net Sales of such Product.

• Immatics may exercise the Co-Commercialization Option, by providing written notice to BMS at any time until the earlier of (i) [**] following its receipt of [**] constituting [**] (the “[**]”) from BMS from the [**] Registrational Trial for a Licensed Product and (ii) [**] months before the anticipated First Commercial Sale [**] of the first Licensed Product in the U.S. (the “Co-Commercialization Option Deadline”).

• Hillside terraces must be located on the portion of the site that is facing south or within 75 degrees of south.

• Xxxxxxxxx shall be entitled to conduct an audit in accordance with this Section 5.8.7 not more than once in any Calendar Year and such audit shall be limited to the pertinent Financial Records from any Calendar Year (i) ending not more than three (3) years prior to the date of the request; or (ii) in the case of audit of the Additional RCC Phase III Costs, from the commencement of the Additional RCC Registrational Trial.

More Definitions of Registrational Trial

Registrational Trial means a human clinical trial (regardless of whether such trial is referred to as a “phase 2 clinical trial”, a “phase 2b clinical trial” or a “phase 3 clinical trial”) that would, based on interactions with a Regulatory Authority or otherwise, (1) satisfy the requirements of 21 C.F.R. § 312.21(c) or corresponding foreign regulations or (2) is designed in a manner such that additional patients could be added such that it could satisfy the requirements of 21 C.F.R. § 312.21(c) or corresponding foreign regulations.

Registrational Trial means a human Clinical Trial that satisfies at least one of the following criteria (regardless of whether such trial is referred to as a “phase 1 clinical trial”, a “phase 2 clinical trial”, a “phase 2b clinical trial” or a “phase 3 clinical trial”):

Registrational Trial means, with respect to any Collaboration CAR-T Product or Licensed Product, (a) a Phase III or (b) any other Clinical Study on a sufficient number of patients, the results of which, together with prior data and information concerning such product, are intended to be, at the time of initiation, without any additional Clinical Studies, sufficient to meet the evidentiary standard for demonstrating the safety, purity, efficacy, and potency of such Collaboration CAR-T Product or Licensed Product is safe and effective for its intended use in the Territory to support Regulatory Approval of such Collaboration CAR-T Product or Licensed Product in the Territory for its intended use.

Registrational Trial means a controlled or uncontrolled human Clinical Trial of a Licensed Product that is intended (as of the time the first patient is enrolled in the Clinical Trial) to obtain sufficient data and results to support the filing of an application for Regulatory Approval without the requirement for any further Clinical Trial prior to submission of such application to the applicable Regulatory Authority.

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.

Registrational Trial means a controlled study in humans (regardless of whether or not called a “Phase 3 Clinical Trial”) for a product the results of which, together with prior data and information concerning such product, are intended to be sufficient, without any additional Clinical Trial, to meet the evidentiary standard for demonstrating the safety and efficacy of such product established by a Regulatory Authority in any particular jurisdiction, and is intended to be sufficient for filing of a BLA (or similar application in a country outside the U.S.) for such product in patients having the disease or condition being studied.

Registrational Trial means a pivotal clinical study for the Contingent Payment Product that is designed to be sufficient to obtain Regulatory Approval.*** Confidential Treatment Requested.