Master Alliance Provisions Guide (MAPGuide)

Novavax – Serum Institute of India, COVID-19 Vaccine Supply and License Agreement

  • Information & materials sharing | Information sharing

4. Information, Quality and Audit

4.9 Safety Reporting. Each Party will advise the other Party in writing of any adverse event related to the Vaccine Components or Product within [***] after becoming aware of such event, and provide any and all information, document, and materials that are related to such adverse event. Further details of the Parties’ obligations in regard to safety reporting will be set forth in the Pharmacovigilance Agreements.