FDA Post-Study Meeting Sample Clauses

FDA Post-Study Meeting. Following delivery of the Complete Data Package to AbbVie as contemplated by Section 3.3.1(i), Receptos shall exercise Commercially Reasonable Efforts to meet with the FDA regarding the status of Development for ABT-308 in the Lead Indication with a goal of assessing whether such Development may proceed directly to the initiation of a Phase 3 without another Phase 2 (the “FDA Post-Study Meeting”). Receptos shall allow AbbVie to review and comment on any materials submitted to the FDA in preparation for the FDA Post-Study Meeting. Receptos shall *** such comments of AbbVie. In addition, representatives of AbbVie may attend, observe and participate in the FDA Post-Study Meeting.
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Related to FDA Post-Study Meeting

  • Meeting Agendas Each Party will disclose to the other proposed agenda items along with appropriate information at least three (3) business days in advance of each meeting of the applicable Committee; provided, that a Party may provide its agenda items to the other Party within a lesser period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such Committee meeting.

  • Review Meeting i. Either the BCTF or BCPSEA may request in writing a meeting to review the issues in a provincial matters grievance that has been referred to arbitration. ii. Where the parties agree to hold such a meeting, it shall be held within ten

  • Shareholders Meeting (a) The Company, acting through the Company Board, shall, in accordance with applicable law: (i) subject to the fiduciary duties of the Company Board, duly call, give notice of, convene and hold a special meeting of its shareholders (the "Special Meeting") as soon as practicable following the execution of this Agreement for the purpose of considering and taking action upon this Agreement; (ii) prepare and file with the SEC a preliminary proxy statement relating to this Agreement, and use its reasonable efforts (A) to obtain and furnish the information required to be included by the SEC in a definitive proxy statement (the "Proxy Statement") and, after consultation with HK, to respond promptly to any comments made by the SEC with respect to the preliminary proxy statement and cause the Proxy Statement to be mailed to its shareholders and (B) subject to the fiduciary duties of the Company Board, to obtain the necessary approvals of the Merger and this Agreement by its shareholders; and (iii) subject to the fiduciary duties of the Company Board, include in the Proxy Statement the recommendation of the Company Board that shareholders of the Company vote in favor of the approval of this Agreement. (b) The Company covenants that the Proxy Statement will comply in all material respects with the provisions of applicable federal securities laws and, on the date filed with the SEC and on the date first published, sent or given to the Company's shareholders, shall not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading, except that no representation is made by the Company with respect to information supplied by HK in writing for inclusion in the Proxy Statement. Each of the Company, on the one hand, and HK, on the other hand, agree promptly to correct any information provided by either of them for use in the Proxy Statement if and to the extent that it shall have become false or misleading, and the Company further agrees to take all steps necessary to cause the Proxy Statement as so corrected to be filed with the SEC and to be disseminated to the holders of Shares, in each case, as and to the extent required by applicable federal securities laws.

  • Initial Meeting (a) The parties must meet within 10 Business Days after the date of delivery of the dispute notice and attempt to resolve the dispute. (b) Each party must use its best endeavors to resolve the dispute and act in good faith.

  • Progress Meetings The Engineer shall from time to time during the progress of the work confer with the State. The Engineer shall prepare and present such information as may be pertinent and necessary or as may be requested by the State in order to evaluate features of the work.