Gates Package — page 64

DRAFT-DRAFT-DRAFT-DRAFT Time-Line of Events for the Current Out-Break e March 2014 - the first cases of Ebola virus in West Africa were reported e August 7, 2014 - Number of infected individuals exceeded 1,711 with 932 reported deaths THERAPEUTICS: Mapp Biopharmaceutical -- ZMapp monoclonal antibody e May 2005 -- NIAID funded Mapp Biopharmaceutical for discovery and early development of monoclonal antibodies (mAbs) for treatment of Ebola virus infections (2006-2011) e@ September 2007 -- NIAID funded Mapp Biopharmaceutical additionally for early development of MB003 mAb cocktail for treatment of Ebola virus infections (2007-2014) e February 2013 -- Defense Threat Reduction Agency funded Mapp Biopharmaceutical for early development of ZMapp mAb cocktail produced in tobacco plants for treatment of Ebola virus infections o Activities covered in year one included non-clinical evaluation and production of nonclinical investigational lots at pilot scale e Late July 2014 -- Medicins Sans Frontieres (MSF) requested product at PHAC lab to be shipped from Sierra Leone, where a stability study of ZMapp was on-going, to the University of Geneva for possible treatment of Dr. Khan, who become infected with Ebola e@ July 29, 2014 -- Samaritan's Purse, which had two American healthcare providers infected with Ebola virus in Liberia, requested ZMapp from PHAC and Mapp Biopharmaceutical, as PHAC had brought a treatment course of ZMapp to West Africa previously for other purposes. CDC and NIAID assisted the NGO in finding the right contact persons at PHAC and the company. DTRA released ZMapp product to Mapp Biopharmaceuticals. e July 31, 2014 - Initial treatment efforts including transfusions with convalescent sera was administered to Patient 1 in Liberia. e August 2, 2014 o. The first treatment course of ZMapp was administered to the two American patients in Liberia. Improvement was noted in both patients. o Emory University Hospital requested ZMapp from Mapp Biopharmaceutical for treatment of the returning American patients. o Emory University Hospital requested from FDA an emergency IND (elND) for use of ZMapp; one treatment course was shipped to Emory University Hospital o NIAID began toxicology studies on ZMapp to assist the DTRA project and support an IND submission e August 5, 2014 - FDA granted an elND to Emory University Hospital for use of ZMapp to treat the returning Ebola-infected Americans from Liberia. They each received additional doses on arrival. e August 2014 --