more than one (1) business day after discovery. HEMISPHERX interprets FDA 21 CFR 314.81, "Other Post- Marketing Reports," to require a Field Alert Report to be made within three (3) days of an occurrence of an OOS result, whether that result is confirmed or not. The only exception to this would be where the original result was invalidated within the three (3) days. In that case, no field alert would be required 8) making the proper reports to the FDA regarding a field alert or recall {***} Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Page 21 of 28 9) making the proper reports to the FDA regarding any serious and unexpected side effects 10) communicating to SCIEN any events of non-conformance that impact the quality of HEMISPHERX's product. Examples of non- conformances may include, but are not limited to: contamination, calculation or documentation error, labeling error. When a non- conformance event occurs HEMISPHERX will conduct an investigation and inform SCIEN of any appropriate action to be taken 11) for initiating, monitoring and completing CAPA tasks related to discrepancies, errors and incidents involving services that are under HEMISPHERX's control 12) contribute to customer complaint investigations where possible issues due to manufacturing process may have contributed to complaint HEMISPHERX and SCIEN are separately responsible for securing and maintaining all required licenses, permits and certificates applicable to their respective operations and each shall comply with any and all applicable federal, state and local laws, including but not limited to (i) the Federal Food Drug and Cosmetic Act; (ii) the Social Security Act; (iii) HIPAA; (iv) all federal and state health care anti-fraud and abuse laws, and