Phase 2b Trial definition

Phase 2b Trial means a Phase 2 Trial constituting a dose exploration, dose response, duration of effect and kinetic/dynamic relationship study of a candidate drug in the target patient population; and

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Phase 2b Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purposes of achieving a preliminary determination of efficacy or appropriate dosage ranges of any product, as described in 21 C.F.R. § 312.21(b) (including any such clinical study in any country other than the United States).

Phase 2b Trial means a Phase 2 Trial, the results of which, alone or in combination with the results of the Phase 2a Trial, would demonstrate the effectiveness of a Product for a particular Indication in patients with the Indication or that would otherwise satisfy the requirements of Part 312 of Title 21 of the United States Code of Federal Regulations or its foreign equivalent.

Examples of Phase 2b Trial in a sentence

• Vaxart shall accept, to the extent permitted by Applicable Law, responsibility for the retention of documentation and storage of samples of Vaccine Candidate and Product used in the Phase 2b Trial and each other Clinical Trial of the Vaccine Candidate contemplated by the Development Plan and conducted by or on behalf of Vaxart during the Development Program Term according to Applicable Law.

• Vaxart shall disclose to Dynavax in writing all Data generated in the Phase 2b Trial or any other Clinical Trial of the Vaccine Candidate, including safety data, data related to the sentinel cohort, topline data, and final data, in each case, promptly (and in any event within [***]) following the first availability thereof.

• In a timeframe to be agreed upon by the Parties, Vaxart shall disclose all safety information arising from the performance of the Phase 2b Trial to Dynavax for inclusion in the global safety database.

• For clarity, delivery of the EOP2 Data Package to Dynavax shall not relieve Vaxart of its obligations with regard to Development Program Activities to be conducted or completed after the Phase 2b Trial Completion Date during the Development Program Term or its obligations under Section 4.3.

• During the Development Program Term, under the oversight of the JSC and subject to the terms and conditions of this Agreement, Vaxart shall retain sole control of, and have sole responsibility for, (a) the Development of the Vaccine Candidate through the completion of the Phase 2b Trial and the EOP2 Meeting, including the performance of Vaxart’s BARDA Obligations, and (b) the Vaccine Candidate and related Product Manufactured by Vaxart for the Phase 2b Trial (collectively, the “Development Program”).

More Definitions of Phase 2b Trial

Phase 2b Trial means, with respect to a Licensed Product, the first to occur of: (a) the second Phase 2 Trial for such Licensed Product or (b) any Phase 2 Trial the principal purpose of which is a determination of efficacy and safety, in the target population, at the intended clinical dose or doses or range of doses, on a sufficient number of subjects and for a sufficient period of time to confirm the optimal manner of use of the Licensed Product (dose and dose regimen) prior to the Initiation of a Phase 3 Trial.

Phase 2b Trial means a Phase 2 Trial, designed to support and immediately precede the initiation of a Phase 3 Trial program without any further Phase 2 Trials, to evaluate the dose-dependent effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study and to determine the common side effects and risks associated with the pharmaceutical product.

Phase 2b Trial has the meaning set forth in Section 3.1.3.

Phase 2b Trial means the Clinical Trial of the Vaccine Candidate described in Vaxart Clinical Protocol No. NCT 06672055, titled “A Study to evaluate VXA-COV2-3.3 COVID-19 Vaccine against currently approved/authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized against COVID-19 Infection,” as amended from time to time in accordance with this Agreement.

Phase 2b Trial means a controlled phase 2b clinical study carried out prior to the

Phase 2b Trial means a controlled phase 2b clinical study carried out prior to the initiation of pivotal Phase 3 Trials (described below) that is intended to be the definitive dose range finding study in patients with efficacy as primary endpoint, as well as safety, initiated after determination of the recommended phase 2 dose of the relevant Licensed Product, that will evaluate the dose-dependent effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study, as well as to collect further adverse effects and safety data to assess the risks associated with the pharmaceutical product, and further pharmacokinetic data. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 2b Trial shall be deemed commenced upon FPFD.

Phase 2b Trial means a Phase 2 Trial, the results of which, alone or in combination with the results of an earlier trial, would demonstrate the efficacy and safety of a Fluorinov Product for a particular indication in patients with the indication or that would otherwise satisfy the requirements of Part 312 of Title 21 of the United States Code of Federal Regulations or its Canadian, European or foreign equivalent.