EOP2 Meeting definition

EOP2 Meeting has the meaning set forth in Section 4.10.3.
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EOP2 Meeting means the end-of-phase 2 meeting with the FDA and/or the equivalent meeting with the EMA to be conducted at the end of the Phase 2a Clinical Trials for a particular Product to discuss the requirements of the FDA or EMA (as applicable) for a Registration Program for such Product to support Marketing Approval. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
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EOP2 Meeting means a Type B meeting with the FDA [*], to evaluate the plans for the Phase 3 Clinical Trial program and protocols, and to identify any additional information necessary to support a marketing application for the uses under investigation.
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Examples of EOP2 Meeting in a sentence

  • Both Parties shall have the right to attend any EOP2 Meeting for a Product Candidate for an Indication under this Section 5.5(c)(i).

  • Notwithstanding the foregoing, Spark’s obligations to provide personnel support to Pfizer as required in Section 4.10.2 shall not be subject to the foregoing limitations until the EOP2 Meeting has been completed.

  • After reviewing the minutes of the EOP2 Meeting, if the Participating Phase IIb Party’s JDC representatives are of the view that such Product Candidate is ready for Phase III Clinical Studies, the Participating Phase IIb Party may proceed under Section 5.6(d).

  • Prior to any EOP2 Meeting for a Product Candidate under a Joint Phase IIb Plan, the JDC shall prepare a briefing package for submission to the applicable Regulatory Authority for such EOP2 Meeting.

  • No later than [**] days following the EOP2 Meeting with the FDA and EMA, Pfizer shall provide Spark with [**] (the “Pivotal Trial Development Plan”), [**].

  • After reviewing the minutes of the EOP2 Meeting, if both Parties’ JDC representatives agree that such Product Candidate is ready for Phase III Clinical Studies in the applicable Indication, the Parties shall proceed under Section 5.5(d).

  • Promptly following the first EOP2 Meeting for a Product Candidate, the Parties shall establish a Joint Supply Committee (the “JSC”).

  • Prior to the EOP2 Meeting for a particular Product, the GDC shall allocate Manufacturing obligations between the Parties with respect to such Product for the Registration Program.

  • Promptly after the EOP2 Meeting with both the FDA and EMA for a particular Product (or in the case in which a Product is only being developed for the US or the EU, but not both, after the applicable FDA or EMA EOP2 Meeting), the Parties shall mutually agree on a procedure for managing Product requests for compassionate use.

  • The objective of each EOP2 Meeting will be to discuss and confirm the clinical development pathway for further Development of the Licensed Products.


More Definitions of EOP2 Meeting

EOP2 Meeting has the meaning set forth in the Evaluation Agreement.
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Related to EOP2 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;

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

  • 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;

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

  • Meeting means any meeting of:

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

  • Board Meeting means a meeting of the Board;

  • 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.

  • Scheme Meeting means such meeting(s) (and any adjournment or postponement thereof) convened with the permission of the Court pursuant to section 896 of the Companies Act for the purpose of considering and, if thought fit, approving (with or without modification) the Scheme of Arrangement.

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

  • Shareholders Meeting has the meaning provided in Section 6.3.

  • Committee Meeting means a meeting of the Committee.

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

  • 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.

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

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

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

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

  • 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.

  • Shareholder Meeting means an annual general meeting of shareholders or special meeting of shareholders of the Company called for the purpose of electing directors to the board of directors of the Company.

  • 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.

  • 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;

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

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

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