Amendment Timelines Clause Samples

Amendment Timelines. This revised proposal is based on the assumption the protocol will be amended to allow PPD to move forward within 30 days of study acceptance. The finalization of this amendment is imperative for the timely submission of the study for both the newly identified institutional sites and those utilizing a central IRB. PPD believes there is great value in conducting a formal kick-off meeting at the start of all projects. This meeting should be facilitated by an unbiased party who will not be directly involved with the project. PPD has personnel that specialize in leading these types of meetings and would be happy to provide a facilitator. Alternatively, PPD has access to independent meeting facilitators and can provide other names for consideration. The purpose of this meeting will be to establish clear communication pathways, expectations and to define roles and responsibilities for all groups involved in this study. At a minimum, specific output from this meeting will include the items listed below: • Team lists containing contact information for all key personnel from each organization along with their primary responsibilities. • Designation of primary contacts from each organization. A clear escalation pathway to be followed in the event that additional follow-up or oversight is needed should also be defined. • Outline of a communication plan to include the frequency of face-to-face meetings and teleconferences (see “PPD/BioVest communication plan” below). • Determination of frequency and type of study status reports to be generated by PPD. (i.e. study start-up reports, enrollment reports, etc.) • Generation of a list of action items and “next steps” along with target completion dates. • Potential items on such a list may include: • Develop CRF completion guidelines • Train team members on study protocol and data validation plan (i.e. review electronic edit checks) • Develop monitoring visit report guidelines or templates Of the 18 additional sites that will be recruited, PPD has assumed that approximately four of those sites will have worked with either PPD or BioVest within the past 12 months and will be granted a Qualification visit waiver. Therefore, PPD has included a total of 14 qualification visits in its proposal. PPD will conduct a complete initiation visit at all newly recruited sites. PPD will also conduct an abbreviated initiation visit by reviewing the protocol and study related procedures with each of the active sites (seven) during the first ...
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Related to Amendment Timelines

  • Amendment, Etc Upon request of the Pass Through Trustee and approval by an Action of Investors, the Escrow Agent and Paying Agent shall enter into an amendment to this Agreement, so long as such amendment does not adversely affect the rights or obligations of the Escrow Agent or the Paying Agent, provided that upon request of the Pass Through Trustee and without any consent of the Investors, the Escrow Agent and Paying Agent shall enter into an amendment to this Agreement for any of the following purposes: (1) to correct or supplement any provision in this Agreement which may be defective or inconsistent with any other provision herein or to cure any ambiguity or correct any mistake or to modify any other provision with respect to matters or questions arising under this Agreement, provided that any such action shall not materially adversely affect the interests of the Investors; or (2) to comply with any requirement of the SEC, applicable law, rules or regulations of any exchange or quotation system on which the Certificates are listed or any regulatory body; or (3) to evidence and provide for the acceptance of appointment under this Agreement of a successor Escrow Agent, successor Paying Agent or successor Pass Through Trustee.

  • AMENDMENT AGREEMENT The Global Custody Agreement of January 3, 1994, (the “Custody Agreement”), as amended from time to time, by and between each of the Entities listed in Schedule A, as amended thereto, severally and not jointly (each such entity referred to hereinafter as the “Customer”) and JPMorgan Chase Bank, whose contracts have been assumed by JPMORGAN CHASE BANK (the “Bank”) is hereby further amended, as of July 21, 2010 (the “Amendment Agreement”). Terms defined in the Custody Agreement are used herein as therein defined.

  • Amendment Terms All revisions to this Agreement may only be made by written amendment executed by both parties and approved by the Office of the Attorney General prior to the end date of this Agreement.

  • Amendment costs If (a) the Borrower requests an amendment, waiver or consent or (b) an amendment is required pursuant to Clause 27.9 (Change of currency), the Borrower shall, within three Business Days of demand, reimburse the Agent for the amount of all costs and expenses (including legal fees) reasonably incurred by the Agent in responding to, evaluating, negotiating or complying with that request or requirement.

  • Amendment to Schedule The Assignor authorizes the Agent to modify --------------------- this Trademark Agreement and the Assignment of Marks, without the necessity of the Assignor's further approval or signature, by amending Exhibit A attached ------- - hereto and the Annex to the Assignment of Marks to include any future or other ----- Trademarks, Trademark Registrations or Trademark Rights under (S)(S)2 or 6 hereof.