Phase I Plan definition

Phase I Plan means, for each Collaboration Target, a plan and budget describing the one or more Phase I Studies to be conducted with respect to such Collaboration Target in the Field that will be established and approved by the JDC, with the goal to provide the Option Data Package for such Collaboration Target.
Sample 1Sample 2Sample 3
Phase I Plan means, for a Phase I Completed Original Product, a plan describing the performance of the Phase I Study for such Phase I Completed Original Product, which is prepared jointly by C4T and Roche and approved by the JDC.
Sample 1Sample 2
Phase I Plan. Phase I Plan means the plan for the Phase I Research Trial set forth on EXHIBIT C to this Agreement, as such plan may be modified from time to time pursuant to Section 2.1.2, which sets forth the genetic, clinical and statistical parameters for the Phase I Research Trial.
Sample 1

Examples of Phase I Plan in a sentence

  • Developer will provide access via the public road as provided for in the PUD Phase I Plan, and not xxx Xxxxxxxx Xxxxx 00.

  • The BOCC acknowledges that the Developer would not make the long term financial commitments necessary to substantially build out the Project in accordance with the approved PUD Phase I Plan or to provide the proffered infrastructure improvements, without Xxxxxxxxx County’s commitment to allow the Project to be governed by and subject to the development laws in effect as of the Effective Date of this Agreement, to the maximum extent permitted by law.

  • Also within the Public Use Site, a +/- 49.0 acre public use site, generally located as shown on the Concept Plan of the PUD Phase I Plan shall be designated for future discretionary use by the County as a school site (the “School Site”, shown as areas 5 & 6 on EXHIBIT 7).

  • Within the Public Use Site, a +/- 30 acre public use site, generally located as shown on the Concept Plan of the PUD Phase I Plan shall be designated for future discretionary use by the County as a park site (the “Park Site”, shown as area 3 on EXHIBIT 7).

  • The Developer may dedicate a +/- 2.0 acre public use site (as shown and described in the PUD Phase I Plan) (the “Water Tank Site”, shown as area 1 on EXHIBIT 7) to the County, for use as a water tank site, should one be needed at the Property, if the County determines one is necessary after evaluating the regional needs while taking into account this Project and the Landsdale PUD and if the County further determines that such water tank shall not be sited on the Landsdale PUD property.

  • Prior to the recordation of the first residential lot, Developer shall dedicate and convey to the County, at the request of the County, a +/- 79 acre public use site located in Areas 3, 5 and 6 as shown on the Concept Plan of the PUD Phase I Plan (the “Public Use Site”, shown as areas 3, 4, 5 & 6 on EXHIBIT 7).

  • Within seven years of finalization of the Phase I Plan, the Fish Managers shall co- author and distribute Phase II of the Klamath River Fisheries Restoration Plan.

  • Developer shall dedicate and convey to the County, a public use site which is not less than 4.0 acres, generally located as shown on the Concept Plan of the PUD Phase I Plan (the "Fire Station Site", shown as area 2 on EXHIBIT 7) for future discretionary use by the County, at or prior to the first residential plat recordation for the Project, or by November 30, 2014, whichever first occurs.

  • Developer shall dedicate, if desired by the County, a +/- 4.0 acre public use site, generally located as shown on the Concept Plan of the PUD Phase I Plan (the "Fire Station Site") for future discretionary use by the County, upon plat recordation for the section of the Project incorporating the Fire Station Site.

  • The Developer may dedicate a +/- 2.0 acre public use site (as shown and described in the PUD Phase I Plan) to the County, for use as a water tank site, should one be needed at the Property, if the County determines one is necessary after evaluating the regional needs while taking into account this Project and the Landsdale PUD and the County further determines that such water tank shall not be sited on the Landsdale PUD property.


More Definitions of Phase I Plan

Phase I Plan means the Company's installation of voice and data switches in Seattle, Washington; Portland, Oregon; Denver, Colorado; and Minneapolis, Minnesota, along with related workforce build-out in such cities and in Reno, Nevada.
Sample 1
Phase I Plan. The plan will establish restoration priorities and criteria for selecting restoration projects over the next ten years. Specific elements will include, but may not be limited to, restoration and permanent protection of riparian vegetation, restoration of stream channel functions, remediation of fish passage problems, and prevention of entrainment of fish into diversions.
Sample 1

Related to Phase I Plan

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • 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).

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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 means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • 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.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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 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 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 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.

  • Project area plan means a written plan that, after the plan's effective date, guides and controls the development within a project area.

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

  • Phase I assessment as described in, and meeting the criteria of, (i) Chapter 5 of the FNMA Multifamily Guide or any successor provisions covering the same subject matter in the case of a Specially Serviced Mortgage Loan as to which the related Mortgaged Property is multifamily property or (ii) the American Society for Testing and Materials in the case of Specially Serviced Mortgage Loan as to which the related Mortgaged Property is not multifamily property.

  • Improvement Plan means the plan required by the Authority from the Supplier which shall detail how the Supplier will improve the provision of the Goods and/or Services pursuant to Clause 29.1.1 (Authority Remedies);

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • The Project Plan means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • 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 Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • 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 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 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).