“Financial Summary and Reporting Form” means a report by the Partner to CEPI in the prescribed form (a template which is attached as Schedule 8) providing up–to–date details of actual and forecast costs for each current Work Package or Additional Work Package.
“Quarterly Report” means a written report to CEPI in the form of the template in Schedule 9 outlining Work Package/Additional Work Package progress, key risks and risk mitigation strategies and up to date financial details relating to the Project.
3. Project Funding
3.7 Stage Gates. On the completion of each Work Package, CEPI will conduct a review of Project progress (“Stage Gate Review”) by convening a CEPI–selected “Stage Gate Committee.” The Partner agrees to participate in the Stage Gate Review and to provide reasonably requested information and hold face–to–face meetings with the Stage Gate Committee and CEPI in a timely fashion to avoid disruption and delay between Work Packages. When the Partner considers that a Work Package has been completed, the Partner shall promptly notify CEPI and, as soon as reasonably practicable, provide CEPI with a report setting out evidence of the achievement of the Stage Gate Criteria by the relevant Stage Gate Date or, where any Stage Gate Criteria or Stage Gate Date have not been achieved, a detailed explanation with supporting evidence as to why this was the case. If the Stage Gate Committee has concerns in relation to the documents referred to above, CEPI shall provide reasonable details of the concerns to Partner and may request additional information. CEPI shall, as soon as reasonably practicable, notify the Partner whether CEPI is willing in principle to fund Work Package 4.3, Work Packages 3 and 5 or the next planned Additional Work Package(s) or declines to fund the next planned Additional Work Package(s). Where CEPI is willing to fund the next planned Additional Work Package(s), the Partner promptly shall provide CEPI with a draft Additional Work Package Statement(s) and the Parties shall agree and sign the Additional Work Package Statement(s) in good faith within [*****] to ensure smooth transition for activities to be pursued in any such Additional Work Packages.
3.11 Third Party funding or support for the Project. The Partner may seek other funding or support (whether in kind or otherwise) for the Project or any Work Package, whether commercial or non–commercial but undertakes not to accept such funding without CEPI’s prior written consent.
3.12 Expenditure of CEPI funding. The Partner shall ensure that the control of expenditure of the CEPI funding and the Partner Contribution are governed by the normal standards, procedures and formal audit arrangements that exist in the Partner. CEPI shall have the right to ask for confirmation from the Partner’s external auditors that the external auditors have signed their opinion on the Partner’s annual accounts of the Partner without qualification and the management letter from the auditors raises no matters that did or could significantly affect the administration of grants awarded by CEPI. If the auditors have raised any such matters in their management letter, CEPI may require the Partner to provide it with relevant extracts from the letter and/or other information.
3.13 Project Audit. On CEPI’s reasonable request, and no more often than once every [*****] the Partner shall procure the Partner’s external auditors to conduct a Project audit and to provide CEPI with audited Project statements (in accordance with ISA800) at CEPI’s cost and expense.
3.15 Partner Financial Records. The Partner shall maintain and retain the Partner Financial Records for [*****] from the end of the financial year the records relate to.
3.16 Audit by CEPI. The Partner shall provide access to the Partner Financial Records to auditors and other personnel from or appointed by CEPI: (i) annually at a mutually agreeable time and location, (ii) on request from CEPI, where CEPI has reasonable grounds indicating that the Partner is in breach of a material obligation under this Agreement, has misapplied CEPI funding or misstated the Partner Contribution; and (iii) on request from CEPI where CEPI is subject to a financial review or audit required by law or by one or more of CEPI’s funders. Such access shall include the right to reasonably inspect during regular business hours at times coordinated with the Partner any equipment or facilities acquired or funded under the CEPI funding or Partner Contribution. CEPI shall bear the cost of the audit unless the Partner is shown to have breached a material obligation of this Agreement, have misapplied CEPI funding or overstated the Partner Contribution. In these circumstances the Partner shall bear the reasonable costs of CEPI’s auditors.
4. Project, Standards And Records Management
4.5 Project Records. The Partner shall ensure that all staff and Sub–Contractors working on the Project keep full, detailed and accurate records of all of their activities and results obtained in connection with each Work Package of the Project; including scientific records of all research, development and other work carried out in respect of each Work Package of the Project and the results of such research, development and other work is performed in accordance with GLP, GCP and GMP as applicable and in a way which is appropriate for patenting and regulatory purposes.
4.6 Access to records. Upon CEPI’s request, the Partner shall make available (and shall procure that its Sub–Contractors make available) to CEPI all records generated in connection with any Work Package of the Project (except for any records which at the time of the request should remain blinded to CEPI in the interests of the integrity of a clinical trial).
4.7 Accuracy of data. The Partner shall use Reasonable Effort to ensure that the Data it maintains and reports to CEPI and the JMAG, are complete, reliable, accurate and not misleading. The provisions in this Clause 4 shall apply mutatis mutandis to Additional Work Packages and Additional Work Package Statements.
5. Project Management And Oversight
5.4 Project oversight. CEPI may appoint a site visit group made up of a small team of independent experts together with some CEPI observers (including representatives of CEPI’s funders) to consult with the Partner’s staff working on the Project, to evaluate progress, performance and key issues and to report back to CEPI and the JMAG on its findings. The Stage Gate Committee (described above) also will be involved in Project oversight. The site visit group shall be bound by confidentiality obligations towards the Partner, no less strict than CEPI’s confidentiality obligations towards the Partner. CEPI shall notify Partner in advance of any independent expert who is an employee or contractor of Third Parties who develop, manufacture and/or otherwise use competitive mRNA technologies. Partner shall have a right to object to the appointment of such independent expert if it has reasonable grounds to believe that such independent expert may get access to Confidential Information. Partner agrees that the site visit group shall have reasonable access during normal working hours and at mutually agreed times to visit the premises where any Work Package activities are being conducted. The site visit group will report back to CEPI on the progress, management and conduct of the then–current Work Package and Project. CEPI will share information from the site visit group with the JMAG.
The provisions in this Clause 5 shall apply mutatis mutandis to Additional Work Packages and Additional Work Package Statements.
7. Partner Obligations
7.11 Partner reporting and compliance. Subject to specific Work Packages, Partner shall provide the following reports, notifications and samples to CEPI:
7.11.1. Financial reports. The Partner shall make the reports required under Clause 3 in accordance with the terms thereof.
7.11.2. Project Technology. The Partner shall ensure that the Project Lead promptly notifies JMAG and CEPI in writing of all Project Technology, and if required by CEPI, provides any assay or animal model for testing by a neutral Third Party acceptable to both CEPI and the Partner. The Partner shall share all Data and results with CEPI and the JMAG in as close to real–time as possible.
7.11.3. Patents. Partner shall inform the JMAG about patent applications filed for Project Technology.
7.11.5. Quarterly Reports. Partner shall provide Quarterly Reports to CEPI within [*****] of the end of each Project quarter.
7.11.9. Equitable Access. Subject to Work Packages, Partner shall provide the following to CEPI to the extent not already included in the reports and information provided by the Partner to CEPI:
(i) progress report on the scale–up of the Platform for Manufacturing and a good faith estimate of the cost of the scale–up where such scale–up is necessary;
(ii) progress report on the scale–up of Manufacturing of Project Vaccine for use in the Field to fulfill any requirements of an Approved Regulatory Authority for the grant of marketing approval for such Project Vaccine for use in the Field in the Affected Territory;
(iii) progress reports on submissions to Regulatory Authorities for a Platform Confirmation or plans to do the same;
(iv) a good faith estimate of the number of doses of each Project Vaccine for use in the Field the Partner and/or Trusted Manufacturers are capable of producing, using the Platform and dates by when Partner estimates such volume will be achieved;
(v) a good faith estimate of Cost of Goods of doses of each Project Vaccine for use in the Field for both the investigational stockpile and any additional doses; and
(vi) the documents and information any estimates are based on together with any information on any factors that may impact the cost of each Project Vaccine use in the Field.
7.11.10. Partner Funder Requirements. The Partner shall notify CEPI promptly of any commitments made by Partner to other funders, such as Gates, for example, that arise or otherwise become applicable after the Effective Date and may have an impact on CEPI’s ability to utilize Project Technology in the event of an Outbreak or risk of an Outbreak and provide an informational copy of such commitments to CEPI.
9. Clinical Trials
9.2 Clinical trial data. Subject to specific Work Packages with respect to each clinical trial under the Project:
9.2.1. the Partner shall procure that the Data is complete and include all completed case report forms and all other clinical trial documentation required to be in the possession of a clinical trial sponsor by Article 15(5) of Directive 2001/20/EC, Article 16 of Directive 2005/28/EC or other relevant applicable law;
9.2.2. a CEPI representative or nominee shall have the right (except for any matters which should remain blinded to CEPI in the interests of the integrity of the clinical trial) to:
– attend meetings of the TSC and the data safety monitoring board (DSMB) for the clinical trial as an observer;
– receive all papers that a member of the TSC or DSMB would be entitled to receive; and
– attend TSC or DSMB meetings by telephone or other electronic means rather than in person.
9.3 Samples. CEPI may engage one or more neutral external Third Party laboratories or Third Party collaborators (“Assessors”) to perform additional testing (at CEPI’s cost) on biological samples in order to provide CEPI with directly comparable evaluations of similar vaccines produced by CEPI’s portfolio of vaccine platforms. In order to maintain appropriate blinding, CEPI may, in its sole discretion and at its own cost, also engage certain neutral Third Party entities to transport the samples from Partner to the Assessor as well as other services, for example, addressing import/export issues or documentation for biological samples (the “Transfer Agent”). The results of the testing, analysis, meta–analysis or other assessments will be subject to the confidentiality obligations under this Agreement. Upon request, CEPI will provide Partner with data or other assessments it receives from the Assessors regarding Partner’s own Project Vaccines, Products and/or Platforms. To enable CEPI to conduct such testing to the extent available, Partner agrees to:
– provide CEPI’s designated Assessor an agreed number of doses of the Project Vaccines, representative of the final drug product, for animal immunogenicity studies;
– provide CEPI’s designated Assessor an agreed number of doses of the Project Vaccines, representative of the final drug product, for animal challenge studies;
– provide CEPI’s designated Assessors (either directly or through the Transfer Agent) with agreed volumes of biological samples (e.g. serum, PBMCs) from human subjects vaccinated with the Project Vaccines in Phase 1 clinical trials at specified timepoints agreed with CEPI for immunology testing;
– provide CEPI’s designated Assessors (either directly or through the Transfer Agent) with an agreed number of samples from clinical studies under the Project for use in future research carried out by or on behalf of CEPI in the Field; – include language in the informed consent forms used in connection with the collection of the biological samples described herein, granting permission for such samples and any associated data (both duly anonymized) to be used for the purposes indicated in this Clause 9 and also that all such informed consent forms have been approved by any and all appropriate ethical committees or institutional review boards; and
– obtain informed consent from the human subjects vaccinated with the Project Vaccines in clinical trials that gives permission for the collection and use of such samples and associated data (duly anonymized and, upon CEPI’s request, blinded) for the purposes indicated in this Clause 9, and also that all such informed consents satisfy the requirements of any and all appropriate ethical committees or institutional review boards.
9.4 Data. CEPI may engage one or more Assessors to perform certain assessments and/or meta–analyses of data (at CEPI’s cost) to provide CEPI with directly comparable assessments of equivalent vaccines produced by CEPI’s portfolio of vaccine platforms. The results of the data analysis or other assessments will be subject to the confidentiality and data protection obligations and the limitations of the Public Health License under this Agreement. Upon request, CEPI will provide the results of such data analysis as regards their own data to the Partner. To enable CEPI or its Assessors to conduct such analyses, subject to specific Work Packages, the Partner agrees to take Reasonable Efforts as follows:
9.4.1. to provide data or other information generated by Partner under this Agreement to CEPI’s designated Assessor as CEPI shall request, including without limitation, data regarding CMC, formulation or the results of any of its pre–clinical or clinical trials (duly anonymized and, upon CEPI’s request, blinded);
9.4.2. to provide CEPI’s designated Assessor with other data (duly de–identified and, upon CEPI’s request, blinded) from the Development as CEPI may reasonably request in order to conduct comparative assessments and meta–analyses thereof;
9.4.3. to include language in the informed consent forms used in connection with the use of data or the collection of samples from which such data is derived, granting permissions for such data (duly de–identified) to be used for the purposes indicated in this Clause 9, and also that all such informed consent forms have been approved by any and all appropriate ethical committees or institutional review boards; and
9.4.4. to obtain informed consent from the human subjects vaccinated with the Project Vaccines in clinical trials that gives permission for the use of data (duly de–identified and, at CEPI’s request, blinded) and for the collection of samples from which data is derived (ensure that all requisite informed consent documentation allowing the provision, transportation, use and analysis of data by CEPI or its designated Assessors as indicated in this Clause 9; and also that all such informed consents satisfy the requirements of any and all appropriate ethical committees or institutional review boards.
The provisions in this Clause 9 shall apply mutatis mutandis to Additional Work Packages and Additional Work Package Statements.