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

  • The Co-Funding Executives will meet at least once per Calendar Year, or more often as may be agreed by the Parties, to discuss the Phase 3 Program Plan, including the associated budget, and any material updates or amendments thereto and, solely if the Profit (Loss) Share is in effect, the U.S. Commercial Plan, as applicable.

  • As between Principia and Sanofi, Sanofi will have the sole right to (a) create and amend the Phase 3 Program Plan, and (b) conduct the Phase 3 Program.

  • In the event Sanofi intends to add or remove any Indications or terminate any studies, in each case set forth in the then-current Phase 3 Program Plan, Sanofi will provide Principia with reasonable notice thereof and Principia will be entitled to comment thereon, provided, however, that the foregoing notice and comment rights of Principia will not apply with respect to any changes of the Phase 3 Program Plan due to patient safety or required by Governmental Authorities.

  • Subject to the other terms of this Section 3 of this Exhibit K-1, all Development activities under the Phase 3 Program shall be conducted in conformance with the Phase 3 Program Plan for the applicable Optioned Product as provided by Sanofi to Principia in connection its exercise of the Co-Funding Option pursuant to Section 5.6 of this Agreement (as may be amended from time to time by Sanofi).

  • Sanofi will provide Principia with an updated version of the Initial Phase 3 Program Plan for the Optioned Product and each updated version thereof, on a semi-annual basis commencing with the date of the Exercise Notice, as well as any other Indications under Development by, or under contemplation for Development by, Sanofi with respect to the Optioned Product and the progress and results of such Development.

  • Development Costs for the Phase 3 Program initially will be [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

  • Within [*]days after the end of each Calendar Quarter, Sanofi will report to Principia the actual Development Costs for the Phase 3 Program incurred by Sanofi during such Calendar Quarter (each, a “Quarterly Report”) and issue an invoice to Principia for the share of such Development Costs due from Principia in accordance with Section 2.1 of this Exhibit K-1.

  • Norgine shall reimburse AMAG for [***] of the Development Costs incurred by AMAG in conducting the Phase 3 Program activities set forth in the Development Plan (the “Norgine Cost Share”), provided that (i) the Development Costs are in accordance with the Phase 3 Budget, and (ii) the Pivotal Clinical Trial is conducted in at least the following [***] countries: [***].

  • The Phase 3 Program Reserve is estimated to increase by $460,582.

  • AMAG shall use Commercially Reasonable Efforts to conduct all Development activities set forth in the Development Plan, including the Pivotal Clinical Trial (consistent with the protocol therefor) and other activities set forth therein related to the Phase 3 Program.

Related to Phase 3 Program

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Development Program means the implementation of the development plan.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 the JDC and that otherwise fit the foregoing definition.

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

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase 3 Study means a clinical study of a drug candidate in human 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 relevant drug candidate may 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 means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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 Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.