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.

  • BTC shall use Commercially Reasonable Efforts to conduct Stage I Development for the use of the Product for the treatment of Frozen Shoulder.

  • 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.

  • Our Business Plan has been developed through two stages which partially overlap: Stage I: Development and Marketing the ▇▇.

  • The proposed Stage I Development Agreement does not provide for an extension of Tremont Drive.

  • The proposed Stage I Development Agreement that was included as Attachment B in the Staff Report states that density is to be calculated by assigning 3.35 persons per single unit dwelling and 2.25 persons for other types of residential units.

  • It should be noted that the proposed amendment to the development agreement does not affect the overall limit of 2,245 persons which will continue to be included in the Stage I Development Agreement.

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.