Successful Study definition

Successful Study means, with respect to a Material Capital Project or Excluded Development/Exploration Property, as applicable, a feasibility study carried out by an Approved Engineering Firm in accordance with Section 6.1 or Section 6.2(a), as applicable, in which the base case demonstrates an estimated internal rate of return for the Material Capital Project or Excluded Development/Exploration Property, as applicable, of 15% or greater (calculated with reference to the two year trailing average gold price immediately preceding the date of the feasibility study, the spot gold price, the reserve gold price and such other reasonable inputs and assumptions as determined by the authors of such study in consultation with the Members, acting reasonably).
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Successful Study means, with respect to a Material Capital Project or Excluded Asset, as applicable, a feasibility study carried out by an Approved Engineering Firm in accordance with Section 6.1 or Section 6.2, as applicable, in which the base case demonstrates an estimated internal rate of return for the Material Capital Project or Excluded Asset, as applicable, of 15% or greater (calculated with reference to the two year trailing average gold price immediately preceding the date of the feasibility study, the spot gold price, the reserve gold price and such other reasonable inputs and assumptions as determined by the authors of such study in consultation with the Members, acting reasonably).
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Examples of Successful Study in a sentence

  • A Material Capital Project that is not supported by a Successful Study may not proceed, and the Operating Member shall not direct the General Manager to prepare a Capital Project Budget, unless the unanimous approval of the Board is first obtained.

  • Long, College of Health Sciences and Human Services, Leading and Managing Nonprofit Organizations➢ Melanie McCallon, Institute for International Studies, Faculty-led 360 Guide to Successful Study Abroad Programs➢ MSU designated with Level V Doctoral Degree Granting Institution status by the Southern Association of Colleges and Schools-Commission on Colleges (SACS-COC).

  • Leaving it to the last minute is not a sensible strategy.B.5 Tips on Successful Study Part of the key to success as an international student is to develop effective study skills and understand the requirements of UK educational qualifications.

  • Huge markets like cloud computing and search engine optimization are good examples of prior business models that have emerged from new technological capabilities.

  • MODULE STRO1101 CODE:MODULE Successful Study for Degree Level TITLE: Psychology CREDITS: 20FHEQ Level: 4JACS CODE: C800 PRE-REQUISITES:NoneCO-REQUISITES: NoneCOMPENSATABLE: No SHORT MODULE DESCRIPTOR: (max 425 characters)This module is designed to help students successfully make the transition to degree level study, specifically developing resilience.

Related to Successful Study

  • Successful Completion means that in the reasonable opinion of the Customer, Deliverables completed by the Supplier are fit for purpose, completed on time and otherwise meet all the criteria defined under this Contract;

  • Successful Vendor means the organization or person with whom the order is placed or who is contracted to execute the work as detailed in the bid.

  • Successful Proponent means a Proponent who the City may award the agreement to, as a result of this RFP document.

  • Successful Applicant means an “employee applicant” or “applicant” who has been offered employment within this Bargaining Unit by the Employer.

  • Successful Bid means the Bid of the Successful Bidder for acquisition of the Corporate Debtor on Going Concern basis as declared by the Liquidator as per this Process Memorandum;

  • Successful Proposer means any Proposer selected by the University to receive an Award as a result of this RFP and to enter into a Contract to provide the University with the products or services sought by this RFP.

  • 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 III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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).

  • 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 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 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.

  • Successful Syndication shall have the meaning given to such term in the Fee Letter.

  • 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 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 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 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 3 Trial means a human clinical trial of a Product on a sufficient number of subjects 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 trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • 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 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.

  • Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

  • 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 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).

  • POC means Point of Compliance. "POE" means Point of Exposure. "PSI" means pounds per square inch.

  • 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).