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 has the meaning set forth in the Evaluation Agreement.
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Examples of EOP2 Meeting in a sentence

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

  • 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.

  • 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).

  • Prior to the Closing, BRC will supplement or amend its disclosure schedule with respect to any matter hereafter arising which, if existing or occurring at the date of this Agreement, would have been required to be set forth or described in such disclosure schedule.

  • 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.

  • Prior to any EOP2 Meeting for a Product Candidate under a Unilateral Phase IIb Plan for an Indication, the Participating Phase IIb Party shall prepare a briefing package, exercising reasonable good faith judgment consistent with the Principles, for submission to the applicable Regulatory Authority for such EOP2 Meeting.

  • The Non-Participating Phase IIb Party shall not have the right to attend any EOP2 Meeting for a Product Candidate under a Unilateral Phase IIb Plan for an Indication under this Section 5.6(c)(ii).

  • 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.


More Definitions of EOP2 Meeting

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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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;

  • Council Meeting means a meeting of Council;

  • 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;