Phase III Development definition

Phase III Development means the conduct of Phase III Clinical Studies of SST Product in the United States as set forth in the then-current Development Plan, including all Development activities incidental thereto.
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Phase III Development means those activities consisting of Phase III clinical trials intended to support regulatory approval of a Licensed Product, including the collection and analysis of data from those trials.
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Phase III Development means any and all activities directed to third phase of human clinical trials of a drug which are large-scale trials to gain evidence of the efficacy and safety in a number of human subjects sufficient to support registration for a product or compound with the FDA, as described in 21 C.F.R. § 312.21(c), as may be amended, or, with respect to any country or jurisdiction other than the United States, its equivalent in such other country or jurisdiction.
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Examples of Phase III Development in a sentence

  • Phase III Development & Major Transportation Event” and remove the Major Transportation Event language.

  • Mr. Gilmore TABLED Resolution #2014-04 to authorize the Administrative Receiver to execute the Iberville/Tremé Choice Neighborhood Initiative Predevelopment Loan Agreement – Iberville On-Site Phase III Development with On Iberville Phase III, LLC in an amount not to exceed $999,465.

  • MINUTES OF THE REGULAR MEETING OF THE BOARD OF COMMISSIONERS FOR FEBRUARY 11, 2014 Resolution #2014-04 – to authorize the Administrative Receiver to execute the Iberville/Tremé Choice Neighborhood Initiative Predevelopment Loan Agreement – Iberville On-Site Phase III Development with On Iberville Phase III, LLC in an amount not to exceed $999,465.

  • During the Reporting Period, the Phase III Development Project (approximately 229 mu, equivalent to153,000 square meters) has been put into construction, of which Stage I project would provide 271 sets of houses opened for sale in July 2018, and 105 sets have been sold and payments have been received at the end of 2018.

  • Approval for taking annual leave is based on the absence not affecting the efficient operation of the organization.

  • This is a crude extrapolation of the results to consider the lifetime effect on this cohort.Results from the one-way sensitivity analyses can be seen in Table 12.

  • The port has to also cater to berthing of port craft like tugs, pilot launches, mooring launches and dredgers.At present the Krishnapatnam Port has 6 no of dredgers, 5 no of tugs, 2 no of barges, 1 no of pilot launches, 1 no of survey launch, 2 no of mooring launches, 2 no of work boats etc., The number of port craft is also expected to correspondingly increase with the Phase III Development.

  • ATTEST: Mayor City Clerk Date: November 9, 1998‌ Subject: Resolution No. re Church Ranch Phase III Development Project Prepared by: Becky Johnson, Economic Development Specialist Max Ruppeck, Planner III Introduction City Council action is requested to designate Church Ranch Business Center Phase III as an Economic Development Project, for the purpose of allowing the development to receive Administrative Review per City Code subsection 11-5- 8(B).

  • At present, Tianma has property interests in Phase III Development Project, which is intended for sale and/or rental and is in the process of construction, completion of which is expected to be around June 2008.

  • Van Rees11Department of Soil Science, University of Saskatchewan, Saskatoon, SK.

Related to Phase III Development

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

  • 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;

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

  • 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;

  • 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.

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

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

  • 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;

  • Cluster development means a contiguous cluster or

  • 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 is begun other than (for the purposes of this Deed and for no other purpose) operations consisting of site clearance, demolition work, archaeological investigations for the purpose of assessing ground conditions, remedial work in respect of any contamination or other adverse ground conditions, diversion and laying out of services, erection of any temporary display of site notices or advertisements and “Commence Development” shall be construed accordingly

  • 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 Phase means the period before a vehicle type is type approved.

  • 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.

  • 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:

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

  • 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.

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

  • 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.

  • 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:

  • 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;

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

  • Development Project means a project for the development of land within a

  • 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.

  • Development Area means that area to which a development plan is applicable.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.