End of Phase II FDA Meeting Sample Clauses

End of Phase II FDA Meeting. If the end of Phase II meeting with the FDA results in a decision by Licensee to materially revise the Development Plan, then the JSC shall review and consider the amendment. If Anacor believes that the material revision would significantly negatively impact the Development, the Development timelines or the potential for success of the Licensed Product, then Anacor shall have the right to provide input on the proposed revisions by Licensee, which input shall be considered in good faith by Licensee. [***] If the Executive Officers are unable to reach consensus, then Licensee shall make the final determination in its sole discretion.
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Related to End of Phase II FDA Meeting

  • Regulatory Meetings The Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA concerning any topic relevant to a Product, as well as Product labeling and post-Regulatory Approval Product labeling discussions with the FDA) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product within [****]* after the Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDL’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDA. The Regulatory Lead Party shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.

  • 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.

  • Amendments Meetings (a) Amendments with Consent of the General Partner. If at any time during the term of the Partnership the General Partner shall deem it necessary or desirable to amend this Agreement (including the Partnership's basic investment policies set forth in paragraph 3(b) hereof), such amendment shall be effective only if approved in writing by the General Partner and, except as specified in this sub-section (a), by Limited Partners owning more than 50% of the Units of Limited Partnership Interest then outstanding and if made in accordance with the Partnership Act. Any such supplemental or amendatory agreement shall be adhered to and have the same effect from and after its effective date as if the same had originally been embodied in and formed a part of this Agreement. The General Partner may amend this Limited Partnership Agreement without the consent of the Limited Partners in order (i) to clarify any clerical inaccuracy or ambiguity or reconcile any inconsistency (including any inconsistency between this Limited Partnership Agreement and the Memorandum); (ii) to delete or add any provision of or to the Limited Partnership Agreement required to be deleted or added by the staff of any federal or state agency; or (iii) to make any amendment to the Limited Partnership Agreement which the General Partner deems advisable (including but not limited to amendments necessary to effect the allocations proposed herein) provided that such amendment is not adverse to the Limited Partners, or is required by law. The General Partner may, however, change the trading policies in paragraph 3(b) of this Agreement without the approval of the Limited Partners when such change is deemed to be in the best interests of the Partnership. In addition, if the General Partner determines to offer Units to the public in the future, the General Partner may amend this Agreement as necessary to effect such public offering without obtaining the consent of the Limited Partners, provided, however, that such amendments are deemed to be in the best interests of the Limited Partners. Amendments that are consistent with the North American Securities Administrators Association's Guidelines for the Registration of Commodity Pools will be presumed to be in the best interests of the Limited Partners.

  • 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.

  • 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.

  • Waiver of Notice; Approval of Meeting; Approval of Minutes The transactions of any meeting of Limited Partners, however called and noticed, and whenever held, shall be as valid as if it had occurred at a meeting duly held after regular call and notice, if a quorum is present either in person or by proxy. Attendance of a Limited Partner at a meeting shall constitute a waiver of notice of the meeting, except when the Limited Partner attends the meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened; and except that attendance at a meeting is not a waiver of any right to disapprove the consideration of matters required to be included in the notice of the meeting, but not so included, if the disapproval is expressly made at the meeting.

  • Inspection; Lender Meeting Company shall, and shall cause each of its Subsidiaries to, permit any authorized representatives designated by any Agent or Lender to visit and inspect any of the properties of Company or any of its Subsidiaries, including its and their financial and accounting records, and to make copies and take extracts therefrom, and to discuss its and their affairs, finances and accounts with its and their officers independent public accountants, all upon reasonable advance notice and at such reasonable times during normal business hours and as often as may be reasonably requested. Without in any way limiting the foregoing, Company will, upon the request of Administrative Agent, participate in a meeting of Agents and Lenders once during each Fiscal Year to be held at Company's corporate offices (or such other location as may be agreed to by Company and Administrative Agent) at such time as may be agreed to by Company and Administrative Agent.

  • Conduct of a Meeting; Member Lists (a) The Board shall have full power and authority concerning the manner of conducting any meeting of the Members, including the determination of Persons entitled to vote, the existence of a quorum, the satisfaction of the requirements of this ARTICLE 7, the conduct of voting, the validity and effect of any proxies and the determination of any controversies, votes or challenges arising in connection with or during the meeting or voting. The Board shall designate a Person to serve as chairman of any meeting and shall further designate a Person to take the minutes of any meeting. All minutes shall be kept with the records of the Company maintained by the Board. The Board may make such other regulations consistent with applicable law and this Agreement as it may deem advisable concerning the conduct of any meeting of the Members, including regulations in regard to the appointment of proxies, the appointment and duties of inspectors of votes, the submission and examination of proxies and other evidence of the right to vote.

  • 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.

  • 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.

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