Stage I Development definition

Stage I Development means pre-clinical and clinical drug development activities reasonably necessary to completing all development activities up to and including the completion of Phase II Clinical Trials for the Product in the Field, including pre-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 I Development in a sentence

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

  • Minor adjustments from the approved Stage I Development Plan may be permitted, provided that the adjustments do not affect the spatial relationship of structures, change land uses, increase overall density, significantly alter circulation patterns (vehicular and pedestrian), decrease the amount and/or usability of open space or recreation areas, or conflict with other applicable requirements of this ordinance.

  • 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.

  • Action to approve the Stage I Development Plan may incorporate any conditions imposed by the planning commission.

  • The planning commission shall hold a public hearing on the proposed application in accordance with the requirements of KRS Chapter 424, and review said application with regard to its compliance with the stated purposes of the RCD Overlay Zone, the required elements of the Stage I Development Plan, and other applicable requirements of this section.

  • If an area, however, is currently zoned MLU, the submission of a Stage I Development Plan for review by the planning commission and the legislative body, shall not be required until the area is proposed to be developed.

  • The impact of the blockchain technology for automating hub-to-hub logistics is determined by identifying the contribution of the technology on the operations performed at the hub and evaluating them to get an optimum outcome.

  • The planning commission shall hold a public hearing on the proposed application (Stage I Development Plan, and where applicable, the zoning map amendment), in accordance with the requirements of KRS Chapter 424, and review said application with regard to its compliance with the stated purpose of the MLU Zone, the required elements of the Stage I Development Plan and other applicable requirements of this section.

  • An applicant, at the time of filing of the application for a map amendment, Stage I Development Plan review, or Stage II Development Plan review, may elect to have any planting adjustments for the same development to be heard and finally decided by the planning commission at the same public hearing set for the map amendment, Stage I Development Plan review, or Stage II Development Plan review, or by the Zoning Administrator as otherwise provided for in this section.

  • If a request with the Planning Commission is filed, the legislative body, shall, within ninety (90) days after the planning commission makes its recommendation, process the proposed Stage I Development Plan.

Related to Stage I Development

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • 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.

  • 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;

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Substantial development means any development of which the total cost or fair market value exceeds two thousand five hundred dollars, or any development which materially interferes with the normal public use of the water or shorelines of the state; except that the following shall not be considered substantial developments for the purpose of this chapter:

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

  • Economic development means all powers expressly granted and reasonably inferred pursuant to SDCL § 9-54.

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

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

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

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

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • 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.

  • 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:

  • 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.

  • 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.

  • Housing development as used in this section, means a development project for five or more residential units, including mixed-use developments. For the purposes of this section, “housing development” also includes a subdivision or common interest development, as defined in Section 4100 of the Civil Code, approved by a city, county, or city and county and consists of residential units or unimproved residential lots and either a project to substantially rehabilitate and convert an existing commercial building to residential use or the substantial rehabilitation of an existing multifamily dwelling, as defined in subdivision (d) of Section 65863.4, where the result of the rehabilitation would be a net increase in available residential units. For the purpose of calculating a density bonus, the residential units shall be on contiguous sites that are the subject of one development application, but do not have to be based upon individual subdivision maps or parcels. The density bonus shall be permitted in geographic areas of the housing development other than the areas where the units for the lower income households are located.

  • 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.

  • Planned unit development means a subdivision characterized by a unified site design, clustered residential units and/or commercial units, and areas of common open space.

  • Mixed use development means a Building used, designed or intended for Residential and Non-Residential uses, where:

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • 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.

  • Cluster development means a contiguous cluster or

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Project Developer means Bidding Company or a Bidding Consortium submitting the Bid. Any reference to the Bidder includes Bidding Company / Bidding Consortium/ Consortium, Member of a Bidding Consortium including its successors, executors and permitted assigns and Lead Member of the Bidding Consortium jointly and severally, as the context may require”;