The Awardee will a. obtain and maintain all regulatory approvals (including ethical committee approvals) necessary or reasonably useful for the conduct of research involving animals; and
b. inform JMAG of any anticipated deviations from the original design of animal studies described in the IPDP and obtain JMAG approval before implementing those changes.
The Awardee will a. record Project Results accurately, completely and reliably in Awardee’s IPDP Records; and
b. identify Project Results in the IPDP Reports provided to the JMAG.
The Awardee will undertake during the Term of this Agreement that all of the statements warrantied above will remain true and correct, and shall notify CEPI promptly in the event that this changes.
The Awardee will a. identify Enabling Rights to CEPI as of the signature date of this Agreement and provide updates to the JMAG regarding the Enabling Rights during the course of the Project;
b. provide an updated list of Enabling Rights to CEPI in the event that the Public Health License becomes exercisable.
c. make no encumbrances regarding ownership or access to Project Results or Enabling Rights that would conflict or interfere with the Public Health License without the express written permission of CEPI, such permission not to be unreasonably withheld, conditioned or delayed.
The Awardee will a. notify the JMAG as Project IP is created, discovered or made; any applications for any rights to Project IP are submitted or are otherwise prosecuted; any application regarding the registration of any Project IP is granted, including the granting of any patent or trade mark, as part of its regular IPDP reports; and ANNEX A: TERMS AND CONDITIONS – SCHEDULE A
b. ensure that it has enforceable policies or written agreements with all of its employees, agents and subcontractors which assign to the Awardee ownership of all Project IP.
The Awardee will a. undertake the activities and comply with the obligations described in the Team Charter; ANNEX A: TERMS AND CONDITIONS – SCHEDULE A
b. participate in the designated activities and meetings of the JMAG;
c. keep accurate, complete and reliable records of activities performed and results arising as a result of the activities set out in the IPDP (“IPDP Records”);
d. maintain the IPDP Records for [***] after the termination or expiry of the Project, or for any longer period as required by law, the CEPI Clinical Trials Policy or Awardee’s own policies;
e. monitor progress of the Project and make IPDP Reports to the JMAG as described in the IPDP;
f. propose amendments to the IPDP and Project Budget to the JMAG, as may be required; however, such amendments may require CEPI approval beyond the JMAG level; and
g. notify CEPI if the Project Lead designated in the IPDP becomes unavailable and designate a replacement reasonably satisfactory to CEPI within [***].
The Awardee will a. sign an agreement with each Sub-Awardee, prior to their conducting any activities under the Project or amend any relevant agreement signed with a Sub-Awardee prior to the Effective Date of this Agreement, to be consistent with Awardee’s relevant obligations to CEPI under the IPDP;
b. in addition to, and without in any way diminishing or otherwise altering, Awardee’s obligations under this Agreement (including Clause 14.3) and under the IPDP with respect to use of Sub-Awardees in LMICs, cooperate with CEPI in good faith and to the extent reasonably possible to preferentially use Sub-Awardees operating in LMICs where Outbreaks are likely to occur in order to build infrastructure and develop experienced personnel in the relevant territory; and
c. promptly provide a copy of each Sub-Awardee agreement or amendment thereto to CEPI, provided that Awardee shall have the right to redact any confidential information contained therein that is not necessary for CEPI to determine compliance with Clause 3.3.
The Awardee will a. use award payments only in accordance with the IPDP, agreed Work Package Streams and Project Budget; ANNEX A: TERMS AND CONDITIONS – SCHEDULE A
b. provide a Financial Report to CEPI regarding its expenditures pursuant to the Project Budget, using the template provided in Annex F; and
c. reimburse CEPI for any funding underspend.
The Awardee will a. comply with applicable laws and regulations;
b. subject to Clause 6.1 and Clause 22.6, comply with CEPI Policies and Procedures;
c. provide access to information to the EC Court of Auditors and Anti-Fraud Office as required; ANNEX A: TERMS AND CONDITIONS – SCHEDULE A
d. to the extent that the Project involves relevant activities, comply with Good Laboratory Practices (“GLP”), Good Clinical Practices (“GCP”) and Good Manufacturing Practices (“GMP”) as defined either in the CEPI Policies and Procedures or otherwise under applicable law or best practice; and
e. notify CEPI promptly to discuss any amended CEPI Policies and Procedures that raise concerns about Awardee’s ability to perform its obligations under this Agreement.
The Awardee will a. be the sponsor of any clinical study (unless CEPI and Awardee otherwise agree in writing);
b. be responsible for obtaining and maintaining all regulatory approvals (including ethical committee approvals) necessary or reasonably useful for the conduct of the clinical trial and appropriate clinical trial insurance cover;
c. publish details of any clinical study in a publicly accessible clinical study register, where patient privacy is upheld, as required under law and, as applicable, prior to the commencement of patient recruitment for such clinical study;
d. ensure that any informed consent form permits the use of Project Results described in these T&Cs and in the IPDP;
e. establish a Trial Steering Committee (TSC) for clinical studies funded by CEPI (whether in whole or in part); ANNEX A: TERMS AND CONDITIONS – SCHEDULE A
f. establish a Data Safety Monitoring Board (DSMB);
g. notify the JMAG and TSC in writing immediately following any Safety Issues or similar events;
h. verify that the clinical study data are complete and include all completed case report forms and all other clinical study documentation required to be in the possession of a clinical trial sponsor by applicable law; and
i. subject to the confidentiality provisions contained in Clause 22.4, permit a CEPI representative or nominee (except for any matters that should remain blinded to CEPI in the interests of the integrity of the clinical study and except for closed sessions) to:
i. attend meetings of the TSC and the DSMB for the clinical study as an observer (either in person or by electronic means); and
ii. receive all papers that a member of the TSC or DSMB would be entitled to receive.
