Phase 3 Program definition

Phase 3 Program means, with respect to an Optioned Product, (a) all Phase 3 Clinical Trials required for (i) the submission of an NDA with the FDA, and (ii) the equivalent filings with the applicable Regulatory Authorities in each of the Major European Countries and Japan, and (b) all Phase 4 Clinical Trials (other than Voluntary Phase 4 Clinical Trials), in each case ((a) and (b)) for the initial Indication described in the briefing package delivered to the FDA for the End-of-Phase 2 Meeting described in Section 5.6 of the Agreement and giving rise to the Exercise Notice (provided that, for purposes of this definition, [*] will be treated as one Indication) and the next Indication pursued by Sanofi (if and to the extent so conducted by Sanofi).
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Phase 3 Program means (a) the Pivotal Clinical Trial, (b) any additional Phase 3 Clinical Trials required to support the filing for Regulatory Approval of the Product with the FDA, the EMA and the MHRA and (c) a human clinical trial intended to confirm the dose of the Product in reversing, reducing, or otherwise inhibiting the effects of edoxaban for use in the Pivotal Clinical Trial. A Phase 3 Clinical Trial that is conducted solely to meet country-specific requirements for Regulatory Approval in such country (i.e., a Regulator-Requested Trial) shall not be considered to be part of the Phase 3 Program.
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Phase 3 Program means the program set forth in the Development Plan to develop a Bioprinted *** Skin Model.
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Examples of Phase 3 Program in a sentence

  • Funding is to be used by Service Managers and Indigenous Program Administrators to off-set their eligible operating expenses (in accordance with the Social Services Relief Fund Phase 3 Program Guidelines) beginning March 1, 2021 and incurred up to December 31, 2021.

  • Phase 3 Program* StudyGoalsDesignOrthopedic model (Bunionectomy)1.

  • The press release stated as follows: Trevena Announces Successful End-of-Phase 2 Meeting with FDA and Outlines Phase 3 Program for Oliceridine — Pivotal efficacy studies to start in 2Q 2016, with topline data expected in 1Q 2017, and NDA filing expected in 2H 2017 — — Phase 3 program includes comparisons to both placebo and morphine — — Webcast and call scheduled for today at 5:30 pm EDT — KING OF PRUSSIA, PA, May 2, 2016 — Trevena, Inc.

  • The plan should include an assessment of existing DSM resources; the five-year target for the DSM Phase 3 Program; a process for EVN and PCs to identify and assess new DSM options on ongoing basis; a strategy and plan for continuing load research activities; and an approach for using integrated resource planning (IRP) to include DSM as integral part of the resource planning process.

  • Knowing all of the above, on May 2, 2016, Trevena issued a press release entitled Trevena Announces Successful End-of-Phase 2 Meeting with FDA and Outlines Phase 3 Program for Oliceridine.

  • Funded by the National Science Foundation (NSF) Course, Curriculum, Learning, and Instruction (CCLI) Phase 3 Program.

  • Claims under $50,000 qualify for expedited proceedings with a decision within 120 days.

  • Phase 3: Program Acceptance and NotificationAll students who meet the program’s qualification requirements are placed on the qualified list.

  • Follow-up support for trainees and BDS clients is a key feature of the Phase 3 Program as is the continued strengthening of provincial level coordination mechanisms to identify evolving priority skills demand in the productive sector and the most appropriate training service response.

  • Altogether, 72 statements were compiled, referring both to the importance of these skills in a future career and to the current realization of science education at school.

Related to Phase 3 Program

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Development Program means the implementation of the development plan.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Development Plan has the meaning set forth in Section 3.2.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 3 Study means a clinical study of an investigational product in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents [***]

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Development Plans has the meaning set forth in Section 3.2.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.