Proposed Study definition

Proposed Study has the meaning set forth in Section 4.4.
Sample 1Sample 2
Proposed Study shall have the meaning assigned to such term in Section 4.3(e).
Sample 1Sample 2
Proposed Study is defined in Section 2.6(i).
Sample 1Sample 2

Examples of Proposed Study in a sentence

  • If not, prior to issuing the Proposed Study Plan, Licensee will describe to the best of its knowledge and understanding the management goals of agencies that have jurisdiction over the resource addressed in this study.

  • Proposed Study Plan: Susitna-Watana Hydroelectric Project FERC Project No. 14241.

  • If provided before Licensee files its Proposed Study Plan and Licensee agrees with the description, Licensee will insert the brief description here stating the description was provided by that agency.

  • Information Sharing and Confidentiality Applicant’s Proposed Study GRDA states that it would distribute relevant cultural resource information to the CRWG so that participants can make meaningful and informed decisions and recommendations.

  • Note: When completing the online application, the Proposed Study / Experimental Plan may be uploaded as a PDF or typed into the text field.

  • Historic Properties Management Plan Applicant’s Proposed Study In its RSP, GRDA proposes to develop an HPMP for the project, in consultation with the CRWG and in accordance with the Advisory Council and Commission’s guidelines.

  • Area of Potential Effects Applicant’s Proposed Study In section 2.5 of the RSP, under cultural resources, GRDA tentatively defines the project’s APE as follows: All lands within the FERC-approved project boundary.

  • Identification of Inundated Resources Applicant’s Proposed Study GRDA’s cultural resources study plan does not include procedures to survey areas permanently inundated by Grand Lake.

  • ARIAD US may in its sole discretion commence and conduct the Proposed Studies and the provisions of Sections 5.6 or 5.7.2 shall not apply to the Proposed Studies but otherwise all provisions of this ARTICLE 5 shall apply as appropriate to a Proposed Study.

  • Schedule and Timing Applicant’s Proposed Study GRDA proposes a two-year period to conduct background research and archeological fieldwork.


More Definitions of Proposed Study

Proposed Study has the meaning set forth in Section 3.6(a).
Sample 1Sample 2

Related to Proposed Study

  • Proposed decision means the presiding officer’s recommended findings of fact, conclusions of law, decision, and order in a contested case in which the administrator did not preside.

  • Proposed Plan As defined in Section 3.17(a)(iii).

  • Proposed Project SCHEDULE: (edit schedule below as appropriate) Project Event Completion Date Pre-bid Meeting Questions Due Proposals Due Begin Work Programming Phase Permitting Phase Schematic Design Phase Design Development Phase Construction Documents Phase Bidding or Negotiation Phase Construction Administration 1-Year Warranty

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Feasibility Study means a comprehensive study of a deposit in which all geological, engineering, operating, economic and other relevant factors are considered in sufficient detail that it could reasonably serve as the basis for a final decision by a financial institution to finance the development of the deposit for mineral production;

  • Proposed Sale has the meaning set forth in Section 2.4(a).

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study 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 clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such 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 II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • 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 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.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Proposed Transfer Notice means written notice from a Key Holder setting forth the terms and conditions of a Proposed Key Holder Transfer.

  • 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).

  • Proposed Works means the sewage works described in the Owner's application, this Certificate and in the supporting documentation referred to herein, to the extent approved by this Certificate;

  • Proposed Transaction is defined in Section 6.2(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).

  • Proposed Transfer means any assignment, sale, offer to sell, pledge, mortgage, hypothecation, encumbrance, disposition of or any other like transfer or encumbering of any Transfer Stock (or any interest therein) proposed by any of the Stockholders.

  • Independent study means a subject/program/activity that a person pursues autonomously that meets standards for approval criteria in the rules and includes a posttest.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Project Proposal is the final and written description of the Project as described in Exhibit A, to be undertaken by Sub-recipient for which the Project Funds is granted and performance is required and monitored pursuant to this PFA.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Proposal means the Technical Proposal and the Financial Proposal.

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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.