Master Alliance Provisions Guide (MAPGuide)

CEPI – CureVac, Framework Partnering Agreement

  • Other | Regulatory strategy

7. Partner Obligations

7.2  Regulatory. Subject to specific Work Packages, the Partner agrees to use Reasonable Efforts develop the regulatory strategy for the Platform for use in the Field and the Project Vaccine for use in the Field, in both cases in accordance with the relevant Work Package Statement for review and approval by JMAG [Joint Monitoring and Advisory Group]. Such strategy shall include the strategy with respect to any data, market or other regulatory exclusivity periods that may be applicable in the Affected Territory or a territory which may be served by an Approved Regulatory Authority.

[“Field” means the diagnosis, prevention and treatment of infections caused by the pathogens listed in the WHO R&D blueprint priority (December 2015 or January 2017) as updated from time to time.]

[“Approved Regulatory Authority means the EU European Medicines Agency, the US Food and Drug Administration, SwissMedic, Japanese PMDA, Australian Therapeutic Goods Agency, South Korean Ministry of Drug Safety, Health Canada, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) or Singapore Health Sciences Authority.]

7.3  IND or CTA. Subject to specific Work Packages, the Partner agrees to use Reasonable Efforts to file for, obtain and maintain an IND or a CTA for Project Vaccine Developed by Partner for use in the Field in both a territory served by an Approved Regulatory Agency and the Affected Territory.

7.4  Master Files for the Platform, and for the commercial use of Project Vaccine. At the request and cost of CEPI pursuant to a specific request from a Regulatory Agency, the Partner agrees to provide copies of Master Files and existing Data for Products to Regulatory Authorities that request such information to support Regulatory Filings and submissions for the Platform and/or for Project Vaccines for use in the Field.

7.5  Meetings with Regulatory Authorities. The Partner shall invite a CEPI nominee to observe relevant interactions between the Partner and Regulatory Authorities relating to the Platform and Project Vaccines for use in the Field. At CEPI’s reasonable request, the Partner will request a meeting with Regulatory Authorities to deal with any significant unresolved issues. The Parties acknowledge and agree that CEPI is bound by confidentiality obligations to the Partner pursuant to Clause 17 of this Agreement and that confidentiality concerns will not prevent the Partner and the Regulatory Authorities from having open and frank discussions in CEPI’s presence.