Phase 1 Concept Plan definition

Phase 1 Concept Plan means the preliminary conceptual plan for the development of the Facilities on the Land as depicted on Exhibit "B-1".
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Examples of Phase 1 Concept Plan in a sentence

  • A maximum of 445 single-family (attached and detached units) and 210 multi-family or condominium units may be constructed within the areas identified as Land Bays A, B, C, E, F, and G on the Phase 1 Concept Plan.

  • All shop drawing submittals shall be sent to Civil Design Inc at least 15 days prior to fabrication.

  • It is proposed that the major will be offered in both the Bachelor of Arts and the Bachelor of Biomedical Science degree courses.The Chair recommends that the Committee endorse the Phase 1 Concept Plan for the introduction of the major in Humanities in Health and Medicine in the Bachelor of Arts and the Bachelor of Biomedical Sciences from 2018, as set out in the agenda attachment, and referring it to the Academic Council for approval, subject to the development of a detailed Phase 2 proposal.

  • In accordance with the terms of the Phase I approval for the All Age PUD, the area identified as Land Bay D on the Phase 1 Concept Plan may be developed, at Owner’s discretion, either as a 200-unit Continuing Care Retirement Community (“CCRC”) or as a maximum of 200 age- restricted dwelling units.

  • It is proposed that the major will be offered in the Bachelor of Arts degree course.The Chair recommends that the Committee endorse the Phase 1 Concept Plan for the introduction of the major in Philosophy, Politics and Economics in the Bachelor of Arts from 2019, as set out in the agenda attachment, and refer it to the Academic Council for approval, subject to the development of a detailed Phase 2 proposal.

  • Members are asked to consider the concept plan for the proposed introduction of a new undergraduate major in Spanish studies from 2018.The Chair recommends that the Committee consider endorsing the Phase 1 Concept Plan for the introduction of a new undergraduate major in Spanish Studies from 2018, as set out in the agenda attachment (Attachment C), and referring it to the Academic Council for approval, subject to the development of a detailed Phase 2 proposal.

  • Members are asked to consider a concept plan for the proposed introduction of the Graduate Certificate in Economics (42230) from 2018 (Attachment E).The Chair recommends that the Committee endorse the Phase 1 Concept Plan for the introduction of the Graduate Certificate in Economics (42230) from 2018, as set out in the agenda attachment, and referring it to the Academic Council for approval, subject to the development of a detailed Phase 2 proposal.

  • The Draft Plan of Subdivision (Figure 2) is largely consistent with the Phase 1 Concept Plan presented at the Public Meeting, reflecting the above changes.

  • Authorizing Award of Contract for Professional Services Phase 1 Concept Plan for Ecological Park – Block 5601, Lot 4.08 – 1707 South Washington Avenue – CME Associates – Not to Exceed $99,883.00.

  • Members are asked to consider a concept plan for the proposed introduction of the Master of Legal Practice (21560) from 2018 (Attachment D).The Chair recommends that the Committee endorse the Phase 1 Concept Plan for the introduction of the Master of Legal Practice (21560) from 2018, as set out in the agenda attachment, and refer it to the Academic Council for approval, subject to the development of a detailed Phase 2 proposal.

Related to Phase 1 Concept Plan

  • Concept Plan means the plan for the Project.

  • 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 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 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 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 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 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.

  • 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 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 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.

  • 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 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 II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • 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.

  • Natural channel design concepts means the utilization of engineering analysis and fluvial geomorphic processes to create, rehabilitate, restore, or stabilize an open conveyance system for the purpose of creating or recreating a stream that conveys its bankfull storm event within its banks and allows larger flows to access its bankfull bench and its floodplain.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • 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.

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

  • 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).

  • 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 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).

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.