is assurance that services are conducted in a timely, consistent and uniform manner and in accordance with current laws, directives, regulations and guidelines, as may be applicable to the specific project(s). These requirements may include those defined by the U.S. FDA's regulations At 21CFR314.80 (Post-marketing reporting of adverse drug experiences for drugs), 21CFR312.32 (IND safety reporting) 21CFR600.80 (Post marketing reporting of adverse experiences for biologics) 21CFR Parts 210 and 211 ("current Good Manufacturing Practices" or "cGMPs") with particular interest in 21CFR211.1.42 (Warehousing), 21CFR211.150 (Distribution), 21CFR211.204 (Returned drug) and 21CFR211.208 (Drug product salvaging), ICH Guidance for Industry: E6 Good Clinical Practice Consolidated Guidance and/or others that may be appropriate for the particular project. 3. Scope This Quality Agreement is to be applied to the activities performed by SCIEN, for HEMISPHERX as specifically defined by the Sales, Marketing, Distribution, and Supply Agreement January ___, 2016 ("Agreement") to which this Quality Agreement is an integral Exhibit. In the event of a conflict between the terms of the Agreement and this Quality Agreement, the terms of the Agreement shall control. Unless otherwise stated in these documents, SCIEN shall follow its Standard Operating Procedures ("SOPs") with respect to the activities it shall carry out in accordance with the Agreement. Copies of all relevant SOPs shall be provided to HEMISPHERX for review during audits. 4. Confidentiality The information and procedures contained in this Quality Agreement are confidential and subject to the terms and conditions of the confidentiality provisions as set forth in the Confidential Disclosure Agreement September 22, 2014 ("CDA") executed by HEMISPHERX and SCIEN. 5. Terms This Agreement between HEMISPHERX and SCIEN shall be in effect beginning the last date of execution set forth on the signature page to the Agreement (the "Effective Date") to which this Quality Agreement is Exhibit 2 and remain in