Individual development account means a contract between an account holder and a fiduciary organization, for the deposit of funds into a financial institution by the account holder, and the deposit of matching funds into the financial institution by the fiduciary organization, to allow the account holder to accumulate assets for use toward achieving a specific purpose approved by the fiduciary organization.
Mining Plan means a mining plan drawn in accordance with clause (b) of sub-section
site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;
Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.
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 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.
Global Development Plan has the meaning set forth in Section 3.1.
Initial Development Plan has the meaning set forth in Section 3.2(b).
State Budget Director means the individual appointed by the Governor pursuant to Section 321 of The Management and Budget Act, 1984 PA 431, MCL 18.1321.
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.
municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;
Project Steering Committee or “PSC” means the committee referred to in Section I.B of Schedule 2 to this Agreement;
county executive committee member means the county executive committee member responsible for matters relating to land;
Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.
Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.
Community Development Director means the Director of City’s Department of Community Development or his or her designee.
Commercial Development Plan means the written commercialization plan attached as Appendix E.
Project Sponsor and “Sponsor” means an Applicant/Co-Applicants who receives a Carryover Allocation of Tax Credits and any other person who acquires an ownership interest in any owner of a project which has received a Carryover Allocation of Tax Credits from the Division.
Project area plan means a written plan that, after its effective date, guides and controls the development within a project area.
Annual Special Tax means the Special Tax actually levied in any Fiscal Year on any Assessor’s Parcel.
Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.
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.
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.
Clinical Trial means any human clinical trial of a Product.
Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.
Urban Coordinating Council Empowerment Neighborhood means a neighborhood given priority access to State resources through the New Jersey Redevelopment Authority.