Page 6 – Eli Lilly and Company If the independent review finds, prior to release, a discrepancy with significant potential to affect critical quality attributes, the product must not be released unless and until the issue is satisfactorily resolved. Any discrepancies found by the independent review, whether prior to or after release, must be reported to the Agency in a summary report, submitted every 14 calendar days, and include Lilly’s corrective and preventive action plans for each discrepancy, including whether market action is required. The plans must include an appropriate evaluation of each discrepancy’s potential impact on any released drug substance and associated drug product. H. Lilly will retain an independent third-party (i.e., not affiliated with Lilly) to conduct laboratory release testing of bamlanivimab drug substance manufactured at Lilly, Branchburg (excluding bioburden and endotoxin testing). Due to implementation timelines, independent third-party potency testing will commence on February 1, 2021. Until February 1, 2021, the Lilly Indianapolis, IN facility may conduct the equivalent of third- party potency testing. Any discrepancies found by Lilly Indianapolis, IN or the independent laboratory must be reported to the Agency in a summary report, submitted every 14 calendar days, and include Lilly’s corrective and preventive action plans for each discrepancy. The plans must include an appropriate evaluation of each discrepancy’s potential impact on any released drug substance and associated drug product. I. Lilly will submit information to the Agency within three working days of receipt of any information concerning any batch of bamlanivimab (whether the batch is distributed or not), as follows: (1) information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article; and (2) information concerning any bacteriological or microscopic contamination, or any significant chemical, physical, or other change in deterioration in the drug product, or any failure of one or more batches of the drug product to meet the established specifications. Lilly will include in its notification to the Agency whether the batch, or batches, in question will be recalled. If FDA requests that these, or any other batches, at any time, be recalled, Lilly must recall them. J. Lilly will not implement any changes to the description of the product, manufacturing process, facilities and equipment, and elements of the associated control strategy that assure process performance and quality of the authorized product without notification to and concurrence by the Agency. K. Lilly will manufacture and test bamlanivimab per the process and methods, including in- process sampling and testing and finishing product testing (release and stability) to meet all specifications as detailed in Lilly’s EUA request. L. Lilly will list bamlanivimab with a unique product NDC under the marketing category of Unapproved Drug- Other. Further, the listing will include each establishment where manufacturing is performed for the drug and the type of operation performed at each such establishment. Reference ID: 4699500