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 (v) all state privacy, and consumer protection laws, including those relating to the use of medical and prescription information for commercial purposes. 10. Subcontractors SCIEN may enter into agreements between SCIEN and a subcontractor. SCIEN will identify the services performed by each such subcontractor. SCIEN is responsible for the performance of all services provided on behalf HEMISPHERX and the compliance of each subcontractor to the terms of this Agreement. HEMISPHERX will be permitted to conduct periodic audits of the subcontractors to assure compliance to applicable GMP's, GLP's and federal regulations (CFR's). 11. Standard Operating Procedures (SOP's) The following HEMISPHERX SOP's are relevant to this Quality Agreement and interactions between HEMISPHERX and SCIEN and affiliates. A. CLN-009 Handling Adverse Event Reports and Records B. RA-001 Post Marketing Adverse Experience Reporting C. QC-006 Investigation of Out of Specification Results 12. Laboratory Controls-N/A 13. Documentation and Record Maintenance SCIEN shall preserve all records in accordance with any applicable federal, state or local requirements. Raw data, documentation, batch records, source documents, product disposition records and reports (collectively, "Documentation") shall be retained by SCIEN for a minimum period of two (2) years after termination or expiration of the Specialty Distributor Purchase and Service Agreement between HEMISPHERX and SCIEN. SCIEN shall, upon written receipt of a written request from HEMISPHERX, finish such Documentation in a format reasonably acceptable to HEMISPHERX with thirty (30) days of receipt of such request. In this case, the Documentation will be shipped to the Quality Assurance Manager named in this Agreement