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 change. Change control requirements should be articulated within the specific operation's documentation practices. HEMISPHERX is responsible for assuring changes 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.) and for informing SCIEN of any changes requested by regulatory agencies. SCIEN agrees to keep HEMISPHERX fully informed of any and all communications with regulatory agencies that may affect the services being provided to HEMISPHERX by SCIEN. This Agreement is not meant to supersede or replace controlled documents typically used to define and record the work to be conducted by SCIEN for HEMISPHERX. Specific requirements of this Agreement and/or any service contracts shall be articulated within SCIEN's current operating procedures and documentation systems. 9. Responsibilities SCIEN is responsible for: 1) case management support services to patients and maintain a 24-hour/365-day a year telephone service for assistance of prescription drug-related medical emergencies to patients 2) the distribution of product, including the shipping, handling and storage and all rules and regulations of every governmental authority having jurisdiction over the shipping, handling, storage, distribution, and dispensing of Product {***} 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 20 of 28 3) confirming the product labelling requirements in the territory 4) conforming to all labeled specifications concerning the shipping, handling and storage of Product 5)