Page 4 – Eli Lilly and Company Bamlanivimab is authorized for emergency use with the following product-specific information required to be made available to healthcare providers and patients/caregivers, respectively, through Lilly’s website at www.bamlanivimab.com: x Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of Bamlanivimab x Fact Sheet for Patients, Parents and Parent/Caregivers: Emergency Use Authorization (EUA) of Bamlanivimab for Coronavirus Disease 2019 (COVID-19) I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known andpotential benefits of bamlanivimab, when used for the treatment of COVID-19 andusedin accordance with this Scope of Authorization (Section II), outweigh its known and potential risks. I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that bamlanivimab may be effective for the treatment of COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act. Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, I have concluded that bamlanivimab (as described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of your product under an EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), bamlanivimab is authorized to treat mild to moderate COVID-19 illness in adults and pediatric patients 12 years of age and older weighing at least 40 kg, who are at high risk for progressing to severe COVID-19 illness and/or hospitalization as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law. III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: Eli Lilly and Company (Lilly) and Authorized Distributors A. Lilly and authorized distributor(s) will ensure that the authorized bamlanivimab is distributed, as directed by the U.S. government, and the authorized labeling (i.e., Fact Sheets) will be made available to healthcare facilities and/or healthcare providers consistent with the terms of this letter. Reference ID: 4699500