End of Phase 2b Meeting Sample Clauses

End of Phase 2b Meeting. Prior to, but no later than [***] months before the anticipated Completion of the Phase 2 Dose-Ranging Trial for a Product, in preparation for the End of Phase 2b Meeting, Novartis will deliver to Akcea drafts of all documents Novartis reasonably determines are necessary for the End of Phase 2b Meeting, including, at a minimum, a draft [***] for the CVOT and the Cardiovascular Risk Reduction (or “CVRR”) Indication Novartis will pursue for such Product, draft [***] and [***]. The Parties will update such draft documents after the primary endpoint and key safety data generated based on the database lock under the statistical analysis plan for such study are available and, within [***] ([***]) calendar days after Completion of the Phase 2 Dose-Ranging Trial for such Product, will promptly convene a special meeting of the CSC for the CSC to mutually agree on the final contents of all such documents prior to Akcea requesting an End of Phase 2b Meeting. If the CSC cannot agree on final versions of such documents within such [***] ([***]) calendar day period, then (i) [***] will have the final decision-making authority regarding the final contents of all such documents to the extent such contents relate to [***] or its Affiliate’s [***], or any information pertaining to [***] or its Affiliate’s other [***] (collectively, “[***] Information”), and (ii) [***] will have the final decision-making authority regarding the final contents of all such documents to the extent such contents do not relate to [***] Information, and each Party will make such final decisions within [***] calendar days. Once such documents are finalized, Akcea will use Commercially Reasonable Efforts to schedule and conduct an End of Phase 2b Meeting. Akcea will invite Novartis to participate in any key internal Akcea meetings Akcea holds to prepare and discuss strategy for the first End of Phase 2b Meeting for such Product. The Parties will mutually agree on a plan and strategy (including key messages) for the conduct of the End of Phase 2b Meeting that reflects Akcea’s role as IND-holder for such Product and facilitates Novartis’ active participation as the Party potentially responsible for conducting the CVOT and IND and MAA/NDA-Holder in the event of Option exercise. Akcea will invite Novartis representatives to attend the End of Phase 2b Meeting and such representatives will participate in such meeting under the direction of Akcea.
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Related to End of Phase 2b Meeting

  • JSC Meetings The JSC will meet at least [**], or more or less frequently as mutually agreed by the Parties, at such times as may be agreed to by the Parties. The JSC will determine its meeting locations, and whether to conduct a meeting in-person, by teleconference, or videoconference. Each Party is responsible for all costs and expenses incurred by it in connection with its participation in the meetings of the JSC. Each Party shall have the right to call a special meeting of the JSC at any time as necessary or desirable to address disputes or other matters within the scope of the JSC’s responsibilities by providing the other Parties with written notice to that effect. The JSC Chairs shall schedule and convene such special JSC meeting as soon as practicable following such notice. Each Party may, from time-to-time and with prior written notice to the JSC members of the other Parties, invite Project Team members and/or others of its employees, consultants or agents to attend relevant portions of a JSC meeting as necessary. The Sponsoring Party shall notify the other Parties in writing in the event that it wishes to invite a Third Party to attend a JSC meeting. Any such notice shall be provided at least [**] business days prior to the relevant JSC meeting and shall identify the relevant Third Party and briefly describe the reasons that the Sponsoring Party wishes to include the Third Party in the meeting. The attendance and participation of such Third Party shall be subject to the prior written consent of the Parties receiving such notice (such consent not to be unreasonably withheld). Any such consent granted by a Party shall be conditioned upon the consultant or contractor being bound by a written confidentiality and non-use agreement that is reasonably acceptable to the consenting Party. In the event the Sponsoring Party requires the attendance of such Third Party at subsequent JSC meetings, approval shall not be required for any Third Party who was previously approved by the other Parties and remains bound by an appropriate written confidentiality and non-use agreement at the time of the Project Team meeting, provided that the Sponsoring Party gives the other Parties prior notice of such attendance and the other Parties do not revoke their consent. The Parties’ respective JSC Chairs (as defined below) shall be responsible for ensuring compliance with the foregoing.

  • Meeting of Shareholders 33 5.3 Access to Information....................................................................... 33 5.4 Confidentiality............................................................................. 34 5.5 Public Disclosure........................................................................... 34 5.6

  • Notice of Special Meeting As soon as practicable after the accrual of any right of the Holders of Preferred Shares to elect additional trustees as described in Section 2.7(b)(i), the Fund shall call a special meeting of such Holders and notify the Calculation and Paying Agent and/or such other Person as is specified in the terms of such Preferred Shares to receive notice (i) by mailing or delivery by Electronic Means or (ii) in such other manner and by such other means as are specified in the terms of such Preferred Shares, a notice of such special meeting to such Holders, such meeting to be held not less than ten (10) nor more than thirty (30) calendar days after the date of the delivery by Electronic Means or mailing of such notice or the delivery of such notice by such other means as are described in clause (ii) above. If the Fund fails to call such a special meeting, it may be called at the expense of the Fund by any such Holder on like notice. The record date for determining the Holders of Preferred Shares entitled to notice of and to vote at such special meeting shall be the close of business on the fifth (5th) Business Day preceding the calendar day on which such notice is mailed or otherwise delivered. At any such special meeting and at each meeting of Holders of Preferred Shares held during a Voting Period at which trustees are to be elected, such Holders voting together as a class (to the exclusion of the Holders of all other securities and classes of shares of beneficial interest of the Fund), shall be entitled to elect the number of trustees prescribed in Section 2.7(b)(i) on a one-vote-per-share basis.

  • Shareholders Meetings IVAX shall call and hold the IVAX Shareholders' Meeting and Bergen shall call and hold the Bergen Shareholders' Meeting as promptly as practicable for the purpose of voting upon the approval of this Agreement pursuant to the Joint Proxy Statement and the Mergers contemplated hereby, and each of Bergen and IVAX shall use its reasonable efforts to hold the Shareholders' Meetings on the same day and as soon as practicable after the date on which the Registration Statement becomes effective. IVAX shall use its reasonable efforts to solicit from its shareholders proxies in favor of the approval of this Agreement and the Mergers contemplated hereby pursuant to the Joint Proxy Statement and shall take all other action necessary or advisable to secure the vote or consent of shareholders required by the FBCA or applicable stock exchange requirements to obtain such approval, except to the extent that the Board of Directors of IVAX determines in good faith after consultation with outside legal counsel (who may be IVAX's regularly engaged outside legal counsel) that the withdrawal, modification or change of its recommendation is required by its fiduciary duties to IVAX's shareholders under applicable Law, and prior to such determination any person (other than Bergen) shall have made a public announcement or otherwise communicated to IVAX with respect to a Competing Transaction that, as determined by the Board of Directors of IVAX in good faith after consultation with its outside legal counsel (who may be its regularly retained outside counsel) and financial advisors, contains terms more favorable to the shareholders of IVAX than those provided for in the Reorganization. Bergen shall use its reasonable efforts to solicit from its shareholders proxies in favor of the approval of this Agreement and the Mergers contemplated hereby pursuant to the Joint Proxy Statement, and shall take all other action necessary or advisable to secure the vote or consent of shareholders required by the NJBCA or applicable stock exchange requirements to obtain such approval, except to the extent that the Board of Directors of Bergen determines in good faith after consultation with outside legal counsel (who may be Bergen's regularly engaged outside legal counsel) that the withdrawal, modification or change of its recommendation is required by its fiduciary duties to Bergen's shareholders under applicable Law, and prior to such determination any person (other than IVAX) shall have made a public announcement or otherwise communicated to Bergen with respect to a Competing Transaction that, as determined by the Board of Directors of Bergen in good faith after consultation with its outside legal counsel (who may be its regularly retained outside counsel) and financial advisors, contains terms more favorable to the shareholders of Bergen than those provided for in the Reorganization. Each of the parties hereto shall take all other action necessary or, in the opinion of the other parties hereto, advisable to promptly and expeditiously secure any vote or consent of shareholders required by applicable Law and such party's Certificate or Articles of Incorporation and Bylaws to effect the Mergers.

  • Shareholders Meeting (a) If required by applicable law in order to consummate the Merger, the Company, acting through its Board of Directors, shall, in accordance with applicable law:

  • Member Meetings (a) There shall be no meetings of the Members unless called by the Board or as otherwise specifically required by the Delaware Act. No Members or group of Members, acting in its or their capacity as Members, shall have the right to call a meeting of the Members.

  • Action at Meeting At any meeting of the Board of Directors at which a quorum is present, the vote of a majority of the directors present shall constitute action by the Board of Directors, unless otherwise required by law, by the Certificate or by these By-laws.

  • Notice of a Meeting Notice of a meeting called pursuant to Section 13.4 shall be given to the Record Holders of the class or classes of Units for which a meeting is proposed in writing by mail or other means of written communication in accordance with Section 16.1. The notice shall be deemed to have been given at the time when deposited in the mail or sent by other means of written communication.

  • 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.

  • Quarterly Meetings At Landlord's request, Tenant shall make the Tenant's property management team and the executive officers of Tenant (or of Tenant's general partner or managing member, if applicable) available to meet with Landlord on a quarterly basis to discuss the Reserve Estimate, the annual budgets and any other items related to the operation of the Facility, which Landlord wishes to discuss. Tenant agrees to give good faith consideration to any suggestions or requests that Landlord may have.

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