FDA Meeting definition

FDA Meeting means the February 7, 2001 meeting between representatives of the FDA, Seller and Purchaser.
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FDA Meeting has the meaning set forth in Section 5.1(c).
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FDA Meeting means a meeting between EIP or any of its Affiliates and the FDA for the purpose of discussing, and gaining FDA’s agreement on, the size, design and endpoints of a Phase 2 Clinical Trial of Licensed Product.
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Examples of FDA Meeting in a sentence

  • FDA Meeting Notification No later than 10 business days prior to the scheduled meeting The contractor shall forward the dates and times of any meeting with the FDA to BARDA and arrange for appropriate BARDA staff to attend the FDA meetings.

  • The Parties shall use Commercially Reasonable Efforts to achieve JDC approval of such updated Development Plan as soon as practicable after the End of Phase IIA FDA Meeting.

  • To facilitate CIRM’s participation in FDA Meetings, Loan Recipient shall notify CIRM as soon as practicable after it has scheduled an FDA Meeting, and shall, upon request, provide CIRM a copy of any data package or other information it intends to provide or has provided to the FDA, as well as any FDA Meeting minutes.

  • To facilitate CIRM’s participation in FDA Meetings, Grantee shall notify CIRM as soon as practicable after it has scheduled an FDA Meeting, and shall, upon request, provide CIRM a copy of any data package or other information it intends to provide or has provided to the FDA, as well as any FDA Meeting minutes.

  • FDA Meeting Notification Within 24 hours of scheduling meeting The contractor shall forward the dates and times of any meeting with the FDA relating to work funded under this contract to BARDA and to the extent practicable arrange for appropriate BARDA staff to attend the FDA meetings.

  • CIRM also has the right to review any data package(s) or other information, including confidential and/or proprietary information, provided by Grantee to the FDA in connection with such FDA Meetings, as well as any FDA Meeting minutes, and to share such information with CIRM’s confidential advisers.

  • Promptly after the End of Phase IIA FDA Meeting, the JPT shall meet to prepare, and shall submit to the JDC for approval, an updated Development Plan covering detailed Development Activities for the remainder of the 2018 calendar year.

  • The initial Development Plan shall be as set forth in Exhibit 2 hereto and shall (a) cover Phase II Development up to and including the End of Phase IIA FDA Meeting and any immediate follow-up Phase II Development activities directly resulting from such meeting and (b) a non-binding, high level projection of the Phase II Development activities to be undertaken thereafter.

  • Conditions Precedent to Obligations of the Company 41 8.1 Accuracy of Representations 41 8.2 Performance of Covenants 41 8.3 Governmental Consents 41 8.4 Agreements and Documents 41 8.5 Absence of Material Adverse Effect 42 8.6 FDA Meeting Minutes 42 8.7 No Restraints 42 8.8 No Legal Proceedings 42 9.

  • Rapporteurs Mtg - 2 docs Scientific Advice - 8 docs FDA: Meeting correspondence log from BLA m1.Also, discussion with FDA in Jan 09 to discuss advanced cancer pre- BLA submission.

Related to FDA Meeting

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

  • 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;

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

  • 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.

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

  • Shareholder Meeting means a meeting of the Company’s shareholders.

  • Meeting means any meeting of:

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

  • Shareholders Meeting shall have the meaning set forth in Section 5.1.

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

  • Special Meeting means a special meeting of the holders of Voting Shares, called by the Board of Directors for the purpose of approving a supplement or amendment to this Agreement pursuant to Subsection 5.4(b);

  • Scheme Meeting means the meeting or meetings of the INM Shareholders or, if applicable, any class or classes of INM Shareholders (including as may be directed by the High Court pursuant to Section 450(5) of the Act) (and any adjournment of any such meeting or meetings) convened by (i) resolution of the INM Board or (ii) order of the High Court, in either case pursuant to Section 450 of the Act, to consider and vote on the Scheme Meeting Resolution;

  • 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)

  • 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;

  • Board Meeting means a meeting of the Board;

  • Stockholder Meeting means each annual or special meeting of stockholders of the Company, or any other meeting of stockholders held in lieu thereof, and any adjournment, postponement, reschedulings or continuations thereof; (k) the term “Synthetic Equity Interests” means any derivative, swap or other transaction or series of transactions engaged in by such person, the purpose or effect of which is to give such person economic risk similar to ownership of equity securities of any class or series of the Company, including due to the fact that the value of such derivative, swap or other transactions are determined by reference to the price, value or volatility of any shares of any class or series of the Company’s equity securities, or which derivative, swap or other transactions provide the opportunity to profit from any increase in the price or value of shares of any class or series of the Company’s equity securities, without regard to whether (i) the derivative, swap or other transactions convey any voting rights in such equity securities to such person; (ii) the derivative, swap or other transactions are required to be, or are capable of being, settled through delivery of such equity securities; or (iii) such person may have entered into other transactions that hedge or mitigate the economic effect of such derivative, swap or other transactions; and (l) the term “Third Party” refers to any person that is not a Party, a member of the Board, a director or officer of the Company, or legal counsel to any Party. In this Agreement, unless a clear contrary intention appears, (i) the word “including” (in its various forms) means “including, without limitation;” (ii) the words “hereunder,” “hereof,” “hereto” and words of similar import are references in this Agreement as a whole and not to any particular provision of this Agreement; (iii) the word “or” is not exclusive; (iv) defined terms used in the singular include the plural and vice versa; and (v) references to “Sections” in this Agreement are references to Sections of this Agreement unless otherwise indicated.

  • 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.

  • special meeting of shareholders means a meeting of any particular class or classes of shareholders and a meeting of all shareholders entitled to vote at any annual meeting of shareholders at which special business is to be transacted.

  • Kick Off Meeting means a meeting convened by the Purchaser to discuss and finalize the work execution plan and procedures with the ITC.

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

  • 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;

  • Stockholders Meeting shall have the meaning set forth in Section 6.2(c).

  • 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.

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

  • Meeting of Members means an annual meeting of members or a special meeting of members;

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