“Safety Issues” means any material concerns regarding safety or efficacy of any Product studied under the Project, including serious adverse events or serious adverse reaction, safety–related signals, product recalls or relevant recommendations from the Data Safety Monitoring Board to place a hold on or to end a clinical study.
6. Compliance with Applicable Laws and CEPI Policies and Procedures
6.3. The Awardee will: […]
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
7. Clinical Studies
7.1 Clinical Studies. If any Work Package includes research involving human subjects, such activities must comply with applicable laws, relevant regulatory agencies and with CEPI’s Clinical Trials Policy.
7.2 Clinical Data. The data arising in the conduct of a clinical trial will be collected in a way that ensures that each subject, prior to enrolment and in accordance with all applicable laws and regulations, including the EU’s General Data Protection Regulation (GDPR), provides informed consent to allow:
a. direct access to her or his medical records;
b. the processing of data relating to her or him and to the movement of that data to other countries, including countries outside of the European Economic Area;
c. the transfer of such data to Awardee;
d. the transfer of anonymised data to CEPI in accordance with Clause 11;
e. the collection and use of clinical study data (duly anonymised and, at CEPI’s request, blinded) in accordance with and for the purposes indicated in Clause 11;
f. the collection and use of biological samples and the use of data (duly anonymised and, at CEPI’s request, blinded) derived from such samples by CEPI or its designated Assessors in accordance with and for the purposes indicated in Clause 12; and
g. the use of such data for the purpose of obtaining approval from applicable regulatory agencies.
7.3 Priority for Certain Clinical Studies. Awardee acknowledges that the pool of subjects available in areas of Outbreak to participate in a clinical study to test products such as the Product may be limited. Accordingly, if CEPI reasonably determines in consultation with experts (for example a sub–group or subcommittee of CEPI’s Scientific Advisory Committee that CEPI determines has appropriate expertise) that a product other than the Awardee’s Product has substantially greater potential, as determined in accordance with WHO guidance or relevant local regulatory guidance and should be used for a particular clinical study of subjects in areas of Outbreak, the Awardee agrees that it shall abide by such decision and will not proceed with any clinical study of the Product with subjects from areas of Outbreak unless agreed with CEPI. In the event that Awardee must discontinue a clinical study of the Product in areas of Outbreak according to CEPI’s determination pursuant to this Clause 7.3, then CEPI shall (i) cooperate with Awardee in an appropriate wind down of the study and (ii) to the extent not funded in advance by CEPI, reimburse Awardee for Awardee’s reasonably incurred non–cancellable expenses relating to such discontinued clinical study. For clarity, Awardee shall not pay back any sums already received from CEPI that have been actually spent by Awardee in connection with such discontinued clinical study. For the purposes of this Clause, CEPI agrees that nothing in this Clause 7.3 will prevent (i) Awardee from undertaking a Pivotal Study in any country; or (ii) Awardee fulfilling its obligations under its risk management plan prepared by Awardee in connection with its biologics license application in any country, including but not limited to post registration efficacy trials or any other commitment with any relevant regulatory authority to conduct a clinical study that would support the development of the Product. For the purposes of this Agreement, “Pivotal Study” shall mean a clinical study designed to fulfil the requirement for the filing of an application for a marketing authorization for a Product and that is acceptable to the relevant regulatory authority as a basis for the grant of a marketing authorization.
7.4. 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;
e. establish a Trial Steering Committee (TSC) for clinical studies funded by CEPI (whether in whole or in part);
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.