a specific condition noted. Out-of-Specification / Out-of-Trend ("OOS / "OOT"): A result that is not within the established specifications or trend, whether these are qualitative or quantitative. Standard Operating Procedures ("SOPs"): Procedures in effect at SCIEN that define the processes and controls by and under which activities are to be conducted to assure compliance with the appropriate Code of Federal Regulations. 7. Communications To assure proper communication, notification and follow-up in a timely manner by both parties, "Key" contacts are listed in Attachment 1 of this Agreement. Key contacts shall have access to project managers and technical staff and, upon reasonable notice and as required, facilitate resolution of any issues. Every effort will be made by SCIEN to accommodate timely communications, including face-to-face meetings, with HEMISPHERX. 8. Change of Control SCIEN will maintain and follow change control SOP(s) to ensure that changes to equipment, procedures, processes, etc. occur in a controlled manner and in compliance with requirements e defined by the U.S. FDA's regulations (see Section 2). The implementation of any change that may directly impact the integrity of the activities conducted or data being supplied for HEMISPHERX will require prior written approval of HEMISPHERX. SCIEN and HEMISPHERX will advise the appropriate organization's staff member (See Attachment 1) before implementation of a change, by either party, to equipment, procedures, specifications, processes, clinical protocols, product claims or facilities directly related to HEMISPHERX's specific products and processes. Each party agrees to review the proposed change in a timely manner and, at its discretion, may audit and/or request an alternative or additional change prior to the implementation of the proposed change. The respective party will review the proposed change, determine if it is reasonably practicable to implement the change and can suggest alternative or additional changes prior to the implementation of the proposed