Proposed Study definition

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

  • If the JAT determines that a study proposal is reasonable and appropriate, the JAT shall assign the development of a Proposed Work Plan for the associated Proposed Study to the appropriate Working Group.

  • Introduction and Background of Study 1 Personal Journey toward the Proposed Study 4 Statement of the problem 5 Purpose of the study and Research Questions 7 Significance of the study/contributions 8 Chapter 2.

  • Any and all costs and expenses incurred by the Grantor in the performance of actions required pursuant to the terms hereof shall be borne solely by the Grantor.

  • Figure 1 -- _Proposed Study Boundary Figure 2 -- _Cost Breakdown In case of conflict between an exhibit and the text of this contract excluding the exhibit, the text of this contract shall control.

  • Personal Journey toward the Proposed Study This research study contributes to my professional development as a teacher.

  • This Agreement does not bind the parties to enter into any other contract or agreement relating to the Proposed Study.

  • Prior to accessing the data, all researchers (and their Head of Proposed Study) must sign the RSU Project Agreement to confirm that they have read and understood all necessary documentation to comply with statutory and regulatory rules relating to data protection and privacy.

  • 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.


More Definitions of Proposed Study

Proposed Study has the meaning set forth in Section 3.6(a).
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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, 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 shall have the meaning set forth in Section 4.2(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 an investigational product in 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 investigational product can 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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 a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 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.