Proposed Study definition

Proposed Study has the meaning set forth in Section 4.4.
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Proposed Study shall have the meaning assigned to such term in Section 4.3(e).
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Proposed Study is defined in Section 2.6(i).
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Examples of Proposed Study in a sentence

  • 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.

  • 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.

  • 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.

  • The Proposed Study Plan Master Schedule (Appendix B) provides the outline for study implementation for individual studies for 2019 and 2020.

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

  • Relicensing Participants – Licensee will include a cost range estimate for this study in its Proposed Study Plan.

  • 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.

  • In short, if there's anything that will likely force our service members back into the arms of payday lenders, this legislation may be it.” The Proposed Study Would Waste Taxpayer Resources and Duplicate Existing Data The “Study” amendment is a litany of slanted research questions hastily written to reach a foregone conclusion.

  • The Proposed Study Would Violate the Financial Privacy of American Heroes It is cynical and disrespectful to those who served and sacrificed to invoke Purple Heart recipients, POW-MIA heroes, and disabled American veterans in a desperate attempt to buoy the earnings of corporate retailers; yet the Study amendment does this.

  • 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.

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) Pre-bid Meeting Questions Due Proposals Due Begin Work Programming Phase Permitting Phase Schematic Design 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, as applicable.

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • 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 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 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 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.

  • 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 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • 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 Key Holders or Investors.

  • 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 has the meaning set forth in Section 2.2(b).

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Proposal means the Technical Proposal and the Financial Proposal of the Consultant.

  • 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 any human clinical trial of a Product.