Master Alliance Provisions Guide (MAPGuide)

Novavax– CEPI Outbreak Response to Novel Coronavirus (COVID-19) Funding Agreement

  • Other | Regulatory strategy
  • 7. Regulatory Activities:
    • 7.1.Regulatory Activities. Awardee shall pursue the regulatory activities described in the iPDP (the Integrated Product Development Plan) and associated Work Package(s).
      • “Work Package(s)” means a discrete set of activities in an iPDP as identified in Annex C. Additional Work Package(s) may be agreed to by the Parties after the Effective Date, which, upon execution by both Parties, shall be annexed to and become a part of this Agreement.
    • 7.2.Meetings with Regulatory Authorities. Awardee shall invite a CEPI or its designee to observe all material interactions between Awardee and regulatory authorities relating to a Project Vaccine. At CEPI’s reasonable request, Awardee shall request a meeting with regulatory authorities to deal with any significant unresolved issues.
    • 7.3.Regulatory Filings. Awardee shall consult regularly with CEPI regarding regulatory strategy for a Project Vaccine and shall provide advance copies of all regulatory submissions for review and comment by CEPI no later than [***] prior to their contemplated submission to a regulatory authority. If a final version is not available by [***] prior to submission, then a mature draft version can be submitted to CEPI for review at that time. Additionally, Awardee shall put copies of the following on a confidential electronic archiving service designated by CEPI:
      • (a) all submissions to regulatory authorities and regulatory filings in respect of a Project Vaccine together with all data included or referenced therein (other than ministerial submissions that do not involve safety or efficacy issues); and
      • (b) material documents and information exchanged between any regulatory authority and the Awardee relating to a Project Vaccine.
    • 7.4.Product Development Standards. To the extent applicable to the Project, Awardee shall comply with Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices.
    • 7.5.Other Access and Cross References. Awardee shall provide access to other regulatory files and records in good faith and as appropriate to achieve the objectives of this Agreement. For clarity, this may include permission to cross reference master files related to the platform on which the Project Vaccine is produced.