Preceding Study definition

Preceding Study means any study that is required by the Company to be completed prior to commencing the Group Study process for the remaining applicant(s) in a Common Study Area. A Preceding Study shall be deemed to have commenced upon execution of the relevant Impact Study Agreement(s) and the initial payment of the study costs. A Preceding Study shall be deemed to be complete upon issuance of the final Impact or Group Study report.
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Preceding Study means any study of an Interconnecting Customer’s Facility within a Common Study Area that is in process prior to the formation of a Group. A Preceding Study shall be considered to be “in process” from the effective date of the fully executed study agreement through the effective date of a fully executed Interconnection Service Agreement. A Group Study will be considered a Preceding Study for any Interconnection Applications received after the Group Window (defined in Section 3.4.1.a.) has closed.
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Preceding Study means any study of an Interconnecting Customer’s
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Examples of Preceding Study in a sentence

  • Only Interconnecting Customers with a Preceding Study have the option to opt out of the Group Study, except as provided in Section 3.4.1 (e) regarding certain safety and reliability exceptions (id.

  • With regard to the EDC’s proposal to bring an applicant with a study preceding a Group Study (but prior to the Preceding Study applicant being issued an ISA) into a Group Study, the EDC and developer representatives agreed to develop language requiring the EDCs to notify an applicant with a Preceding Study as early in the process as possible that a Group Study was forming behind them in the queue, and the applicant may be brought into the Group Study.

  • The crux of the issue is whether the Project wasa Preceding Study and whether the Company had the right to place the Project in a Group Study.

  • The parties also agreed to discuss language that would limit pulling a Preceding Study into a Group Study to a one-time occurrence to remove risk of perpetual/ongoing re-study.

  • NextSun alleges that if the Company provided its Project with an Impact Study Agreement (“ISA”) within 25 business days of the application being deemed complete, the Project would have been a Preceding Study and not included in the Group Study (NextSun In. Br. at 9-12; 18).

  • The parties also discussed developers’ alternative proposedrevision that would only allow a Preceding Study to be brought into the subsequent Group Study with the preceding interconnecting customer’s consent; agreement was not reached on this proposal.

  • The Preceding Study is the Impact Study that was in process when the Group was formed, so the Time Frame for the Preceding 3 Any scope and costs of ISO New England studies shall be considered to be separate from the scope and costs of a Group Study.

  • NextSun alleges that if the Company met the interconnection timeframes, its Project would have been a Preceding Study and could have been studied individually.

  • Under the plain language of the Group StudyProvision as approved by the Department, Eversource contends that NextSun’s project was not subject to a Preceding Study when the Plymouth Group Study was formed on June 12, 2020 (Eversource Brief at 14).

  • Clean Energy Parties support giving the preceding study the sole discretion to opt-in and join a group study/solution that forms behind it.EDC Response The EDC’s new language relative to Interconnecting Customers with a Preceding Study (i.e., preceding Interconnecting Customer) is intended to enable the EDCs to provideinterconnection solutions for an area that maintains safety and reliability, uses resources efficiently, and supports cost effectiveness for customer-funded system modifications.


More Definitions of Preceding Study

Preceding Study means any study of an Interconnecting Customer’s Facility within a Common Study Area that is in process prior to the formation of a Group. An on-goingA
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Preceding Study means any study of an Interconnecting Customer’s Facility within a Common Study Area that is in process prior to the formation of a Group. An on-goingA Preceding Study shall be considered to be “in process” from the effective date of the fully executed study agreement through the effective date of a fully executed Interconnection Service Agreement. A Group Study will be considered a Preceding Study for any interconnection applicationsInterconnection Applications received after the Group StudyWindow (defined in Section 3.4.1.a.) has commencedclosed. Interconnecting Customers with a Preceding Study (that is not an on-going Group Study) shall not be required to be part of a Group or participate in a Group Study, but may be part of the Group interconnection solution as set forth in Section 3.4.1.d) below.
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Preceding Study means any study of an Interconnecting Customer’s Facility within a Common Study Area that is in process prior to the formation of a Group. An on-going Group Study will be considered a Preceding Study for any interconnection applications received after the Group Study has commenced. Interconnecting Customers with a Preceding Study (that is not an on-going Group Study) shall not be required to be part of a Group or participate in a Group Study.
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Related to Preceding Study

  • 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 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 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 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.

  • 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 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).

  • 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 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 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 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 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 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.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • 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.

  • 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;

  • 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 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 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.

  • 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 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.

  • 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 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.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • 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.

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.