Post Phase II Meeting definition

Post Phase II Meeting means a meeting between Dara and the FDA following completion of a Phase II Clinical Trial to test the safety and efficacy of a Licensed Product for a particular indication in the Licensed Field as a result of which Dara is authorized to proceed with a phase III clinical trial or to file a Drug Approval Application.

Related to Post Phase II Meeting

  • Court Meeting means the meeting(s) of the Scheme Shareholders to be convened by order of the Court pursuant to section 896 of the Companies Act, notice of which will be set out in the Scheme Document, for the purpose of approving the Scheme, including any adjournment thereof;

  • Review Meeting means a meeting to be held in accordance with clause B19 (Review Meetings) or as otherwise requested in accordance with clause B19.2 (Review Meetings)

  • Virtual Meeting means any general meeting of the Shareholders (or any meeting of the holders of any Class of Shares) at which the Shareholders (and any other permitted participants of such meeting, including without limitation the chairman of the meeting and any Directors) are permitted to attend and participate solely by means of Communication Facilities.

  • Scoping meeting means a meeting between representatives of the applicant and the EDU conducted for but not limited to the following purposes:

  • meeting of shareholders means an annual meeting of shareholders or a special meeting of shareholders;

  • Open meeting or "public meeting" means a meeting at which the public may be present.

  • Board Meeting means a meeting of the Board;

  • hybrid meeting means a general meeting convened for the (i) physical attendance by shareholders and/or proxies at the Principal Meeting Place and where applicable, one or more Meeting Locations and (ii) virtual attendance and participation by shareholders and/or proxies by means of electronic facilities;

  • special meeting in lieu of an annual meeting means a special meeting called by Directors for the purpose of electing Directors in the event that an annual meeting is not held on or before such date as may be required by the NYSE Amex, New York Stock Exchange or such other exchange or trading system on which shares are principally traded, if applicable.

  • Company Meeting means the special meeting of Company Shareholders, including any adjournment or postponement of such special meeting in accordance with the terms of the Arrangement Agreement, to be called and held in accordance with the Interim Order to consider the Arrangement Resolution.

  • ordinary meeting means a meeting held by determination of the Board (SER r.115(1)).

  • Closed Meeting means a meeting from which the public is excluded.

  • Meeting Date means the date of the Meeting;

  • General Meeting means the annual or any special general meeting of the Association.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • relevant meeting means a meeting of the authority to consider whether or not to approve a proposal to dismiss a relevant officer; and

  • Annual Meeting means the annual meeting of the stockholders of the Company.

  • physical meeting means a general meeting held and conducted by physical attendance and participation by shareholders and/or proxies at the Principal Meeting Place and/or where applicable, one or more Meeting Locations;

  • Meeting of Members means an Annual Meeting of Members or a Special Meeting of Members.

  • Special Meeting shall have the meaning set forth in Section 23(c)(i) hereof.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Committee Meeting means a meeting of the Committee.

  • Pre-bid Meeting means Pre-bid meeting to be held as per the schedule indicated in the Schedule for the Tender hereof;

  • Public meeting means a meeting that is required to be open to the public under Title 52, Chapter 4, Open and Public Meetings Act.

  • JRC has the meaning set forth in Section 2.1.1.

  • JDC has the meaning set forth in Section 3.2.