Investigator Meeting Sample Clauses

Investigator Meeting. Coordination It is assumed that one investigator meeting will be held in US. Omnicare CR’s Meeting Manager will coordinate arrangements associated with the investigators’ meeting for this Project. Our Meeting Manager has extensive experience in conducting investigators’ meeting, including but not limited to, organizing and scheduling the meeting, making cost-effective travel arrangements for participants, and providing on-site coordination services. The Meeting Manager will participate on the weekly Project Team teleconference in addition to managing all logistics of the meeting.
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Investigator Meeting. SPONSOR will plan and coordinate an investigator meeting to be attended by the investigators and assistants from each study site as well as representatives from TKL. ****Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. The meeting will be presented jointly by SPONSOR’s and TKL at a location and date to be determined. The objective of this meeting will be to orient the investigators to the requirements of the protocol with specific attention devoted to subject selection and qualification, randomization scheme, efficacy measurement devices, interview procedures, and investigator assessments of subject progress so as to standardize methodologies across investigative sites. Case Report Forms will be reviewed with detailed discussions of the correct procedures for completing them. The obligations of the investigators conducting investigational drug studies will be presented. All investigators who do not attend the investigator’s meeting will be initiated by a TKL CRA. Initiations will occur after the site has a fully executed contract, IRB approval, and all study materials, clinical supplies and study drug have been delivered to the site. It is estimated that TKL will conduct 5 sites initiations.
Sample 1
Investigator Meeting o For this proposal we have assumed that CroMedica will organize and conduct an investigator meeting in S. Africa, including logistics, correspondence with participants and agenda in consultation with ACS, with presenters from CroMedica and ACS. Medica expertise for the meeting will be provided by ACS as discussed. o Pass-through costs include transportation, accommodation and meals for CroMedica staff, including the project manager, a clinical operations assistant and CRAs. ACS Responsibilities o Investigator budget negotiations, fees and fee administration are not included in the budget, and will be the responsibility of ACS. o It is assumed that ACS will provide the protocol, CRFs, laboratory services and biometry services. o It is assumed that ACS has in place a Medical Monitor to whom CroMedica will report all serious adverse events and refer questions about inclusion/exclusion criteria and protocol interpretation. IRBs o CroMedica has assumed the use of individual institutional IRBs. Site Responsibilities o It is assumed that sites will provide all necessary regulatory documentation, transcribe data on to CRFs, provide adequate resources for the conduct of the study, provide source documentation, remain in compliance with the protocol and report all adverse events. 21 Project Management and Monitoring o CroMedica will provide comprehensive management of the study to include: -leadership, direction and problem-solving -ensuring all regulatory requirements are met -site selection and initiation -provision and supervision of CRAs -scheduling of visits -review of trip reports -supply tracking -timeline preparation and updates -progress reports to ACS -meetings and communications with ACS and monitors -weekly teleconferences with CRAs for status up-dates o All trial related activities undertaken by the CroMedica project team are conducted in accordance with CroMedica SOPs and ICH/GCP guidelines. Where requested, ACS SOPs can be used. o CroMedica policy dictates that an indication- and protocol-specific CRA training seminar occur as an adjunct to the investigator meeting. Otherwise, a training seminar will be planned before commencement of the study. o CroMedica will prepare a monitoring plan, define the scope of work for the monitors, and distribute all relevant study materials to monitors. o Time allotted for monitoring visits includes preparation, time on-site, travel time and trip report.
Sample 1
Investigator Meeting. MDS Pharma Services’ IPD will participate to one Investigator Meeting, in Germany. This meeting will be attended by MDS Pharma Services’ IPD, as well as representatives from GENTIUM. MDS Pharma Services will participate to the meeting documents preparation (slides/overheads, hand-outs, etc.). During the investigator meeting, GENTIUM will brief the investigators on the study drug and the aim of the trial, and participate in all discussions that ensue. MDS Pharma Services will present the protocol and e-CRF, and conduct a thorough review of the monitoring activities (including respective responsibilities and SAE reporting guidelines), ICH GCP and regulatory aspects of the study.
Sample 1

Related to Investigator 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.

  • 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.

  • 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.

  • 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.

  • Lenders Meetings Borrower will, upon the request of Administrative Agent or Requisite Lenders, participate in a meeting of Administrative Agent and Lenders once during each Fiscal Year to be held at Borrower’s corporate offices (or at such other location as may be agreed to by Borrower and Administrative Agent) at such time as may be agreed to by Borrower and Administrative Agent.

  • Holders Meetings Section 9.01. Purpose of Meetings 45 Section 9.02. Call of Meetings by Trustee 45 Section 9.03. Call of Meetings by Company or Holders 45 Section 9.04. Qualifications for Voting 46 Section 9.05. Regulations 46 Section 9.06. Voting 46 Section 9.07. No Delay of Rights by Meeting 47

  • Shareholder Meetings All expenses incidental to holding meetings of shareholders, including the printing of notices and proxy materials, and proxy solicitations therefor.

  • 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.

  • Meetings Meetings of the Trustees shall be held from time to time upon the call of the Chairman, if any, or the President or any two Trustees. Regular meetings of the Trustees may be held without call or notice at a time and place fixed by the By-Laws or by resolution of the Trustees. Notice of any other meeting shall be given by the Secretary and shall be delivered to the Trustees orally not less than 24 hours, or in writing not less than 72 hours, before the meeting, but may be waived in writing by any Trustee either before or after such meeting. The attendance of a Trustee at a meeting shall constitute a waiver of notice of such meeting except where a Trustee attends a meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting has not been properly called or convened. Any time there is more than one Trustee, a quorum for all meetings of the Trustees shall be one-third, but not less than two, of the Trustees. Unless provided otherwise in this Declaration and except as required under the 1940 Act, any action of the Trustees may be taken at a meeting by vote of a majority of the Trustees present (a quorum being present) or without a meeting by written consent of a majority of the Trustees. Any committee of the Trustees, including an executive committee, if any, may act with or without a meeting. A quorum for all meetings of any such committee shall be one-third, but not less than two, of the members thereof. Unless provided otherwise in this Declaration, any action of any such committee may be taken at a meeting by vote of a majority of the members present (a quorum being present) or without a meeting by written consent of all of the members. With respect to actions of the Trustees and any committee of the Trustees, Trustees who are Interested Persons in any action to be taken may be counted for quorum purposes under this Section and shall be entitled to vote to the extent not prohibited by the 1940 Act. All or any one or more Trustees may participate in a meeting of the Trustees or any committee thereof by means of a conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other; participation in a meeting pursuant to any such communications system shall constitute presence in person at such meeting.

  • Stockholder Meetings All expenses incidental to holding meetings of Stockholders, including the printing of notices and proxy materials, and proxy solicitation therefor.

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