from the perspective of such experience not being anticipated from the pharmacological properties of the pharmaceutical product. Call report: A list of all questions, requests for circulars, and physician/patient complaints received by SCIEN's Clinical Support Department is prepared monthly by SCIEN staff and is forwarded to HEMISPHERX RA/QA Department. Audit: A systematic examination of processes, controls and systems, operating procedures, reports, records and/or data to assess SCIEN's compliance with standards, regulatory submissions, SOPs; applicable laws, regulations, directives, standards and guidelines; the terms of this Agreement and other contracts in place defining the services being provided and to verify data integrity. Good Clinical Practices ("GCPs"): Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. ICH Guidance for Industry: E6 Good Clinical Practice Consolidated Guidance. Good Manufacturing Practices ("GMPs"): The recognized pharmaceutical regulations and requirements of regulatory authorities such as those defined by the U.S. FDA's regulations at 21CFR Parts 210 and 211. Key Contacts: Persons at SCIEN and HEMISPHERX assigned to assure proper communication and follow-up in a timely manner within both parties' organizations. Names, titles and full contact information for Key Contacts shall be appended to this Agreement as Attachment 1 and should be maintained up-to-date during the course of the project. Observation: A statement of fact made during an audit that is substantiated by objective evidence. HEMISPHERX categorizes observations as follows: o Critical: May pose risk to patient or consumer or otherwise compromise the integrity or quality of the material, product, process, or