Preliminary Study definition

Preliminary Study has the meaning given in clause 8.2(a).
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Preliminary Study has the meaning given in clause 8.2(a) of the Joint Venture Agreement.
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Preliminary Study has the meaning given in clause 8.2(a) of the Joint Venture Agreement. * * * Pursuant to a request for confidential treatment filed with the Securities and Exchange Commission, confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission
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Examples of Preliminary Study in a sentence

  • Importantly, this view of the firm does not involve any sort of philanthropy; rather, it represents a new way to achieve economic success.

  • Stewart Macaulay, Non-Contractual Relations in Business: A Preliminary Study, 28 AM.

  • A Quantitative Method for Assessing Stroke-impaired Sense of Motor Effort: A Preliminary Study.

  • If the government finds the information provided in the request (Law “On Expropriation of Property for Public and State Purposes”, article 7, part 2) satisfactory a decree “On Preliminary Study of Property Subject to Expropriation” is adopted.

  • Etiology of Diarrhea, Nutritional Outcomes and Novel Intestinal Biomarkers in Tanzanian Infants: A Preliminary Study.

  • The Lessee agrees to pay the Lessor on a three-month basis the pre-lease interest on the payment date and in the amount as set forth in the applicable Pre-lease Interest Payment Notice issued by the Lessor.

  • The Oregon POLST Registry: A Preliminary Study of EMS Utilization.

  • JICA thereafter dispatched the Preliminary Study Mission headed by Mr. Akira Nakamura to the Philippines to investigate mapping policies and scope of conducting the Topographic Mapping for Integrated National Development Plan in September 2005.

  • The Manager may (and will, if directed by an Owner) * * * provide to the Owners’ Council for review a Preliminary Study for that Subsequent Sole Risk Development Proposal in accordance with clause 8.2(a).

  • Where there is a conflict between this Agreement and the Greenway Crossing and Preliminary Study JPA, this Agreement shall govern.


More Definitions of Preliminary Study

Preliminary Study means a clinical study that _____ intends to conduct following the Effective Date as generally described on Exhibit E attached hereto.
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Preliminary Study means a drawing of a proposed subdivision to be approved by the Planning Commission and County Board of Supervisors before proceeding with a final plat.
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Preliminary Study means a clinical study that LabCorp intends to conduct following the Effective Date as generally described on Exhibit E attached hereto.
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Preliminary Study as used in this PA, Preliminary Study means a preliminary analysis of a proposed CDF project to determine if potential impacts to cultural resources could result from project activities.
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Related to Preliminary Study

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • 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 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 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 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 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).

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • 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 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 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 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.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

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

  • Additional Filing Date means the date on which the Additional Registration Statement is filed with the SEC.

  • Development Plan has the meaning set forth in Section 3.2.

  • 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 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 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).

  • Clinical Trial means any human clinical trial of a Product.

  • 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.

  • 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.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • 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.

  • Project Implementation Unit or “PIU” means the unit referred to in Section I.A.1 of Schedule 2 to this Agreement.

  • 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.

  • Commercially Sensitive Information Schedule means the Schedule containing a list of the Commercially Sensitive Information.