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).

Phase 3 shall have the meaning set forth in Section 1.4.

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.

Examples of Phase 3 in a sentence

• HDK shall pay a civil penalty of two hundred seventy-five thousand dollars ($275,000.00 USD) and agrees to fund a Supplemental Environmental Project (SEP) entitled, Marine Vessel Speed Reduction Incentive Program Phase 3, in the amount of two hundred seventy-five thousand dollars ($275,000.00 USD), consistent with CARB’s SEP Policy, for a total settlement of five hundred and fifty thousand dollars ($550,000.00 USD).

• The Parks and Open Space Plan, the Infrastructure Plan, the Schedule of Performance and the Phasing Plan for Major Phase 3 provide for the design and improvement of Wedge Park 2b, The Last Rubble, Wind Meadow, CP Neighborhood Park, Wedge Park 3, Bayview Gardens, Grasslands South 1, Grasslands South 2, Heritage Park, Palou Ave, Waterfront Promenade North Pier, Community Sports Fields, Maintenance Yard, Grassland Ecology Park, and Multi-Use Open Space.

• At CDOT, project management responsibilities will be applied in three phases: Phase 1: Planning Phase 2: Preconstruction Phase 3: Construction A project which is effectively managed has a clearly defined scope and strategy which is well executed, monitored, and controlled.

• HDK has agreed that by funding the SEP entitled Marine Vessel Speed Reduction Incentive Program Phase 3, HDK will not receive any direct or indirect financial benefit, and that whenever HDK publicizes or refers to the SEP or the results of the SEP, HDK will state that the SEP is being undertaken as part of the settlement of a CARB enforcement action.

• The amount of any such retention shall not exceed the estimated cost to the Agency of completing the Final Public Improvements (the “Final Public Improvements Cost”), determined as follows: not less than ninety (90) days before submitting the Major Phase Application for Major Phase 3, Developer shall notify the Agency of its detailed estimate of the Final Public Improvement Cost, together with appropriate backup information.

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.

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.

Phase 3 means the period for the plant construction and initial operation for the manufacture of the LICENSED PRODUCT.

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.

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.

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.

Phase 3. Fees associated with custom engineering, implementation, as well as Corillian's expenses, shall be paid on an as incurred monthly basis.,