Master Alliance Provisions Guide (MAPGuide)

CEPI – CureVac, Framework Partnering Agreement

  • Consortium structure & management | Reporting Requirements

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.

7.11.4. Epidemiology. Partner agrees to make data generated pursuant to clinical trials in the Field that are relevant to the epidemiology of any disease in the Field publicly available within [*****] of the generation of such data.

7.11.5. Quarterly Reports. Partner shall provide Quarterly Reports to CEPI within [*****] of the end of each Project quarter.

7.11.6. Safety Issues. The Partner shall notify CEPI and relevant JMAG members immediately by email (with receipt acknowledgement) as well as in writing in accordance with Clause 21.9:

(i) on receipt of any information that raises any material concerns regarding safety or efficacy of Product or the Platform;

(ii) where any data relating to a Product discloses a serious adverse event;

(iii) where a serious adverse event is suspected;

(iv) on the occurrence of a serious adverse event, serious adverse reaction, or any other material safety signal;

(v) of any Product recalls; and

(vi) of any recommendations from the data safety monitoring board for a clinical trial of a Product to end a clinical trial;

(together, the “Safety Issues”).

7.11.7. Pharmacovigilance. The Partner shall notify CEPI promptly in writing of any relevant event under any pharmacovigilance activities;

7.11.8. Insurance. The Partner shall:

(i) provide CEPI with a copy of each insurance policy and certificate referred to in Clause 18.9 annually on renewal; and

(ii) notify CEPI of any claims made under the insurance policies referred to in Clause 18.9 during the Project Term and for at least the duration of any applicable statutory period of limitation afterwards.

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.