Page 7 – Eli Lilly and Company M. Through a process of inventory control, Lilly and authorized distributor(s) will maintain records regarding distribution of the authorized bamlanivimab (i.e., lot numbers, quantity, receiving site, receipt date). N. Lilly and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA. Healthcare Facilities to Whom the Authorized BamlanivimabIs Distributedand Healthcare Providers Administering the Authorized Bamlanivimab O. Healthcare facilities and healthcare providers will ensure that they are aware of the letter of authorization, and the terms herein, and that the authorized Fact Sheets are made available to healthcare providers and to patients and caregivers, respectively, through appropriate means, prior to administration of bamlanivimab. P. Healthcare facilities and healthcare providers receiving bamlanivimab will track serious adverse events that are considered to be potentially attributable to bamlanivimab use and must report these to FDA in accordance with the Fact Sheet for Healthcare Providers. Complete and submit a MedWatch form (www.fda.gov/medwatch/report.htm), or Complete and submit FDA Form 3500 (health professional) by fax (1-800-FDA-0178) (these forms can be found via link above). Call 1-800-FDA-1088 for questions. Submitted reports should state, “use of bamlanivimab was under an EUA” at the beginning of the question “Describe Event” for further analysis. Q. Healthcare facilities and healthcare providers will ensure that appropriate storage and cold chain is maintained until the product is administered consistent with the terms of this letter. R. Through a process of inventory control, healthcare facilities will maintain records regarding the dispensed authorized bamlanivimab (i.e., lot numbers, quantity, receiving site, receipt date), product storage, and maintain patient information (e.g., patient name, age, disease manifestation, number of doses administered per patient, other drugs administered). S. Healthcare facilities will ensure that any records associated with this EUA are maintained until notified by Lilly and/or FDA. Such records will be made available to Lilly, HHS, and FDA for inspection upon request. Conditions Related to Printed Matter, Advertising and Promotion T. All descriptive printed matter, as well as advertising and promotional material, relating to the use of the bamlanivimab under this authorization shall be consistent with the authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations. U. No descriptive printed matter, as well as advertising or promotional material, relating to the use of bamlanivimab may represent or suggest that such products are safe or effective when used for the treatment of mild to moderate COVID-19 in adults and pediatric patients with Reference ID: 4699500