Phase 3 definition

Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).
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Phase 3 shall have the meaning set forth in Section 1.4.
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Phase 3 means a controlled or uncontrolled human clinical trial of a compound or product that would satisfy the requirements of 21 CFR 312.21(c) or its foreign equivalents.
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Examples of Phase 3 in a sentence

  • Xxxxx is also required to pay development milestones to the former AlmataBio stockholders, including $5 million due upon the first patient dosed in a Phase 2 trial in patients with HS for AVTX-009 and $15 million due upon the first patient dosed in a Phase 3 trial for AVTX-009, both of which are payable in cash, Xxxxx stock, or a combination thereof at the election of the former AlmataBio stockholders, subject to the terms and conditions of the definitive merger agreement.

  • In addition, GWCHF shall review with City personnel, and provide an original fully executed sworn affidavit, from the Project’s architect or general contractor certifying the actual amount spent on Phase 1, Phase 2 and/or Phase 3.

  • No101073781 • X2.0 Open Call #3 – HealthTech & BioTech • The Phase to which the payment is associated [Phase 1, Phase 2, Phase 3] • Beneficiary information (e.g. beneficiary company name) The invoice or the FIF is to be sent to xxxxxxxxxx@x0x.xxx and xxxx@x0-0.xx.

  • Medpace, Institution and Principal Investigator entered into a Clinical Trial Agreement as of 13-October-2017 (the „Agreement“) pursuant to which Principal Investigator is conducting a Study based on Protocol No. INCB 39110-301, entitled „ GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus- Host Disease “ (the „Protocol“), and Dodatek č.

  • IQVIA, Institution and Sponsor are parties to an agreement entitled Clinical Trial Agreement for Protocol “A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma (CLEAR)” protocol No. E7080-G000-307, effective as of 10 October 2017 (the “Agreement”), and the parties desire to amend such Agreement; DODATEK Č.


More Definitions of Phase 3

Phase 3 means a human clinical trial of a Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
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Phase 3 means a human clinical trial of a Molecule or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that such Molecule or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Molecule or Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
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Phase 3 means the third phase of human clinical trials of a drug required by the FDA or other equivalent regulatory authority to gain evidence of efficacy in the target population and obtain expanded evidence of safety for Product(s), as described in 21 C.F.R. Part 312, as it may be amended.
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Phase 3 means that portion of the drug development and review process in which expanded clinical studies are conducted to gather the additional information to establish the effectiveness and safety that is needed to satisfy the requirements of a pivotal trial for obtaining regulatory approval to market an investigational new drug, as more specifically defined by the rules and regulations of the FDA or a similar regulatory requirement in any national jurisdiction.
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Phase 3. “Phase 4”, “Phase 5”,”Phase 6”, “Phase A”, “Phase B” and “Phase C”. Except as expressly set forth in Sections 1.2.2, 1.3 and 1.4, Landlord shall deliver each Phase of the Premises to Tenant in its then “as-is” condition without any representations or warranties regarding condition.
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Phase 3 means execution or construction phase.
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