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

  • 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.

  • 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).

  • Akebia further agrees to permit its books and records to be examined by an independent accounting firm selected by Licensee to verify the accuracy of Development costs for the Global Phase 3 Program and COGS.

  • 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.

  • About the Fovista® Phase 3 Program The Fovista® Phase 3 program consists of three clinical trials to evaluate the safety and efficacy of Fovista® (anti-PDGF) therapy, which Ophthotech is developing for use in combination with anti- VEGF drugs for the treatment of wet age-related macular degeneration.

  • 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.

  • 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.

  • Except as provided in Section 2.2.1 of this Exhibit K-1, Section 11.1(b) of this Agreement will apply in the event of any dispute regarding the calculation or reporting or breach of payment of Development Costs for the Phase 3 Program.

  • In exchange for, and as a condition to, receiving the Co-Funding Compensation, Principia will be responsible for payment to Sanofi of [*] of all Development Costs incurred with respect to the Phase 3 Program, subject to the caps set forth in Section 2.5 of this Exhibit K-1 (such capped [*] amount, the “Co-Development Funding”).

  • With respect to each Calendar Quarter during which Principia is or becomes a Reporting Company, within [*] days after the end of each Calendar Quarter, unless not practicable, Sanofi shall provide a good faith estimate of its Development Costs for the Phase 3 Program in the form of a written report [*] = 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.

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 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, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.

  • 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 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.