EOP2 definition

EOP2 means all activities from the first-▇▇▇▇▇ study through to completion of Phase 2 (as defined in 21 C.F.R. 312.21(b)) followed by an End of Phase 2 Meeting with FDA for a product; and
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EOP2 means the end of Phase II meeting conducted with a Regulatory Authority in the Salix Territory.
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Examples of EOP2 in a sentence

  • 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.

  • 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).

  • 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”), [**].

  • These terms and conditions form a part of, and amend, the Cardholder Agreement applicable to your Account.

  • The Parties will jointly prepare for each EOP2 Meeting, including (a) formulating the plan for further Development of Licensed Products and the regulatory strategy and pathway for such Product and (b) the preparation of any correspondence and filings with the Regulatory Authorities.

  • 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.

  • Shortly thereafter, Licensee plans to file for an end of Phase 2 (EOP2) meeting to confirm the pivotal trial(s) and other tasks needed to support NDA filing.

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

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