Stage II Development definition

Stage II Development means non-clinical and clinical drug development activities reasonably necessary to the development and submission of Regulatory Data to a Regulatory Authority for the purpose of achieving Regulatory Approval, including non-clinical studies, test method development, statistical analysis, Clinical Trials, regulatory affairs, and activities directed to seeking Regulatory Approvals.
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Examples of Stage II Development in a sentence

  • The planning commission shall submit, along with their recommendations, a copy of the Stage II Development Plan and the bases for their recommendation.

  • The planning commission, or its duly authorized representative, shall review the submitted Stage II Development Plan with regard to its compliance with the required elements of Section 9.20, B.

  • The legislative body shall forward a copy of the approved plan to the planning commission for further processing, in accordance with the requirements for Stage II Development Plan and Record Plat.

  • A copy of the approved Stage I Development Plan shall be forwarded to the planning commission, or its duly authorized representative, for further processing, in accordance with the requirements for a Stage II Development Plan.

  • Stage II - Plan And Record Plat - A Stage II Development Plan and record plat shall be developed in conformance with the Stage I approved plan and in accordance with the requirements of Section 9.20, B.

  • The planning commission, or its duly authorized representative, shall review the submitted Stage II Development Plan with regard to its compliance with the required elements of Section 9.20, B., for Stage II plans, other applicable elements of this ordinance and other applicable regulations, and its conformity with the Stage I approved plan.

  • Following review of the submitted Stage II Development Plan, the planning commission, or its duly authorized representative, shall make one of the following recommendations to the city's chief administrative official, or his/her duly authorized representative: approval, approval with conditions, or disapproval.

  • The city's chief administrative official, or his/her duly authorized representative, shall, within ninety (90) days after the planning commission, or its duly authorized representative, makes its recommendation, process the proposed Stage II Development Plan.

  • Upon approval of the Stage II Development Plan by the city's chief administrative official, or his/her duly authorized representative, the zoning administrator shall grant permits only in accordance with the approved Stage II Development Plan, and other regulations as may be required by this ordinance.

  • At such time as the Stage II Development Plan for a particular development is submitted to the planning commission, or its duly authorized representative, notwithstanding Subsection C., 2., a., open space requirements of less than twenty (20) percent may be considered for the development if unique topographic conditions exist, unique treatment of parking areas is provided for, and unique conditions and circumstances exist on or are adjacent to the site.

Related to Stage II Development

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Existing development means development, other than that associated with agricultural or forest management activities, that meets one of the following criteria:

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Residential Development means lands, buildings or structures developed or to be developed for residential use;

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • Major development means an individual “development,” as well as multiple developments that individually or collectively result in:

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • Commencement of Development means the date on which any material operation (as defined in Section 56(4) of the Act) forming part of the Development begins to be carried out other than (for the purposes of this Deed and for no other purpose) operations consisting of site clearance, demolition work, archaeological investigations, investigations for the purpose of assessing ground conditions, remedial work in respect of any contamination or other adverse ground conditions, diversion and laying of services, erection of any temporary means of enclosure, the temporary display of site notices or advertisements and “Commence Development” shall be construed accordingly.

  • New development means development resulting from the conversion of previously undeveloped land or agricultural land uses.

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Development means any man-made change to improved or unimproved real estate, including, but not limited to, buildings or other structures, mining, dredging, filling, grading, paving, excavation or drilling operations, or storage of equipment or materials.