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

  • To the extent that Auxilium pays any Stage I Development Costs resulting from additional Stage I Development that is requested or required by a Regulatory Authority after assuming responsibility for Development of the Product for any Indication, Auxilium shall be entitled to set-off the amount of such Stage I Development Costs against any amounts due to BTC pursuant to Section 7.1.

  • Except as specified herein, requirements shall be as approved in the Stage I Development Plan.

  • Slightly larger percentages of cities and counties reporting a centralized approach than those reporting decentralized approaches had comprehensive preventive maintenance; but because the number of cases was small the relationship was not significant.

  • Such records of the Company, together with a copy of this Agreement and of the Certificate, shall at all times be maintained at the principal place of business of the Company or some other location chosen by the Board and shall be open to inspection and examination at reasonable times by each Member and its duly authorized representative for any purpose reasonably related to such Member's interest as a Member of the Company.

  • MOVED by Councillor Whalen, seconded by Councillor Walker to give Notice of Motion to consider an application by Angela and Scott Bryant to amend the Stage I Development Agreement for Langbrae Gardens, Phase 2D and schedule the Public Hearing for December 3, 2001.

  • His clients were interested in a configuration that would generate a larger number of smaller units.• His company came up with a scenario that provided for 99 units - 179 people.• Just recently, the Planner indicated that the Stage I Development Agreement has a suggestion that the variance could not be more than 20%, which would equate to 96 units.

  • The Stage I Development Agreement focused on the conceptual design, the location of commercial development opportunities, the location of residential development by types, number of units, building heights and the establishment of a phasing plan.

  • Requirements shall be as approved in the Stage I Development Plan.

  • Insufficient information was submitted to determine if the Stage I Development Plan met the minimum requirements of the Elsmere Zoning Ordinance.

  • MOVED by Councillor Whalen, seconded by Councillor Mosher to give Notice of Motion to consider an application by Pacrim Developments Limited to amend the Stage I Development Agreement for Clayton Park West, Phase 4 and schedule the Public Hearing for July 16, 2001.

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, 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;

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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 Mhlontlo 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:

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

  • 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