Gates Package — page 60

Dear Gary, Great call -- thanks for facilitating the discussions. I wanted to circle back with you and make sure I understand what FDA's current action item is with respect the outcome of our discussions. We are prepared to draft a document that is more generic with respect to regulatory considerations for Ebola therapeutics, and will also include some product-specific thoughts/recommendations. However, before we send that to you, we need to make sure that we invoke the PHEMCE MOU and have all participants of the WG sign the attached non-disclosure agreement so that we can share non-public information for the purpose of this WG's deliberations. Please see the attached document which is the PHEMCE MOU NDA "blessed" by ESC/EEC (if you need the actual MOU signed by all PHEMCE partners, please let me know). <<! ICC Form - 2014 PHEMCE MOU.PDF>> Also before we start the any discussion which will include non-public information, we need to state the following per the MOU SOP: "This discussion may include trade secret or confidential commercial information protected from disclosure to the public under the Freedom of Information Act, the Trade Secrets Act, the Federal Food, Drug, and Cosmetic Act, or FDA regulations. Each participant must have signed an individual PHEMCE Confidentiality Commitment to participate today, and information provided may only be shared with employees or contractors who sign a PHEMCE Confidentiality Commitment. Please identify yourself if you have not yet signed this agreement and we will provide one to allow for your continued participation today. Participants should not further disclose or otherwise make public the information that is shared." Finally, am happy to be the liaison for our FDA group, and appreciate that you go through me for all of your needs and concerns. One recommendation that our FDA group would like me to convey to you is that we strongly believe that NIAID/IRF should be included in the Ebola/Marburg MCM WG - specifically Lisa Hensley and/or her staff as they are engaged in much of the early research and even have boots on the ground in Africa and are in a position to share data that are critical to our deliberations. Thanks, Jean