Page 5 – Eli Lilly and Company B. Lilly and authorized distributor(s) will ensure that appropriate storage and cold chain is maintained until the product is delivered to healthcare facilities and/or healthcare providers. C. Lilly and authorized distributor(s) will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., U.S. government agencies, state and local government authorities, authorized distributors, healthcare facilities, healthcare providers) involved in distributing or receiving authorized bamlanivimab. Lilly will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized accompanying materials (i.e., Fact Sheets). D. Lilly may request changes to this authorization, including to the authorized Fact Sheets for bamlanivimab, that do not alter the analysis of benefits and risks that underlies this authorization and FDA may determine that such changes may be permitted without amendment of this EUA. That determination must be made by joint decision of the Office of Infectious Diseases/Office of New Drugs/Center for Drug Evaluation and Research (CDER),the Counter-Terrorism and Emergency Coordination Staff/Office of the Center Director/CDER, and Office of Counterterrorism and Emerging Threats/Office of the Chief Scientist/Office of the Commissioner. E. Lilly will report to FDA serious adverse events and all medication errors associated with the use of the authorized bamlanivimab that are reported to Lilly using either of the following options. Option 1: Submit reports through the Safety Reporting Portal (SRP)as described on the FDA SRPweb page. Option 2: Submit reports directly through the Electronic Submissions Gateway (ESG) as described on the FAERS electronic submissions web page. Submitted reports under both options should state: “use of bamlanivimab was under an EUA.” For reports submitted under Option 1, include this language at the beginning of the question “Describe Event” for further analysis. For reports submitted under Option 2, include this language at the beginning of the “Case Narrative” field. F. All manufacturing facilities will comply with Current Good Manufacturing Practice requirements. G. Lilly will retain an independent third party (i.e., not affiliated with Lilly) to conduct a review of the batch records and any underlying data and associated discrepancies of bamlanivimab drug substance manufactured at Lilly Branchburg, NJ. x For all batches manufactured prior to the effective date of this authorization, these batches can be released while review is ongoing. x For all batches manufactured after the effective date of this authorization, the third party review can be performed concurrent to Lilly’s batch release process. Reference ID: 4699500