of complaints and actions taken or to be taken to address the complaints 17) the performance of all services provided by SCIEN's subcontractors 18) communicating to HEMISPHERX any events of non-conformance that impact the quality of HEMISPHERX's product. Examples of non-conformances may include, but are not limited to: equipment failure, shipping error or documentation error, labeling error, improper storage, facilities system error, and unplanned study protocol deviations. When a non-conformance event occurs that is specific to HEMISPHERX's product, SCIEN will conduct an investigation and provide copies of all investigation documentation to HEMISPHERX for review and input 19) for initiating, monitoring and completing CAPA tasks related to discrepancies, errors and incidents involving services that are under SCIEN's control HEMISPHERX is responsible for: 1) release of product following review of all manufacturing and quality control testing requirements to confirm the batch has been manufactured according to approved processes and specifications 2) supply all necessary quality documentation with shipments to allow product importation and release 3) ensuring product intended for supply in territory is labelled accordingly 4) assuring changes to the established operations are in accordance with and/or reported to the investigational, marketing and/or any other filing with regulatory agencies (IND, IMPD, CTA, NDA, MA, etc.). 5) informing SCIEN of any changes requested by regulatory agencies 6) assist with/address any Agencies requests relating to manufacture of product 7) providing SCIEN any information that could result in a field alert or recall of a product under a HEMISPHERX NDA or ANDA immediately, but no 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