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.
View Source

Examples of Stage II Development in a sentence

  • In the event Auxilium assumes responsibility for Stage II Development of the Product for an Exercised Indication, Auxilium shall be responsible for all Development Costs related to the Product for such Exercised Indication and incurred by Auxilium after the Exercised Indication Date; provided, however, that BTC shall continue to be responsible for all Development Costs which are incurred prior to the Exercised Indication Date.

  • More detailed, Stage II Development Agreements (Map 3) were negotiated for each subsequent phase.

  • The subject property is within Schedule ‘K’ and governed by Stage I and Stage II Development Agreements for the Glenbourne Development, which is located to the west of Dunbrack Street, between ▇▇▇▇▇▇▇ ▇▇▇▇ West and Rockingham Ridge development, north and west of the Wedgewood subdivision and east of the Bicentennial Highway in Halifax.

  • Signage for commercial uses shall be determined through a Stage II Development Agreement.

  • In the event Dulles Stage II is undertaken pursuant to Paragraph 10.04.1(iv), the Original Cost Estimate, as revised pursuant to this Paragraph 10.04.2, for the Dulles Stage II Development Plan shall not be exceeded except as set forth in this Article.

  • By rezoning the property to Schedule K it can be developed in the form of Stage I and Stage II Development Agreements as set out through Implementation Policies 3.1 and 3.2. Please see a detailed analysis of policies 3.1 and 3.2 above.

  • Thereafter, the Authority may proceed with construction of the Dulles Stage II Development Plan and (i) Paragraph 10.04.5 shall not apply, and (ii) to the extent that the Authority expends funds for the Dulles Stage II Development Plan from the Authority's share of Net Remaining Revenues or from any balance in the Authority Capital Fund, there shall be no Amortization Requirement.

  • Estimate applicable to a Project in the Capital Development Program (except the Early Program and the Dulles Stage II Development Plan) at either Airport exceeds the Original Cost Estimate, as revised pursuant to Paragraph 10.03.1, for that Project by more than five percent (5%) percent, the Authority shall promptly notify the Airline Representative.

  • Capital Development Program shall mean the construction, acquisitions and improvements to the Airports, as more particularly described in Exhibits N-I and D-I attached hereto, including the Dulles Stage II Development Plan.

  • The proposed application includes applying the Schedule K Zone to the subject properties which would identify this area on the Zoning Map and signify that a Stage I and Stage II Development Agreement is required and needs the approval of Council before any development permits can be issued.