I certify that the information provided in this application is complete and accurate to the best of my knowledge, and that once the investigational product requested under the American Regent Expanded Access Program is approved for release to this patient, I will be responsible for supervising the patient’s treatment. I understand and certify that all units of any investigational product shipped to me pursuant to this application will be provided to the above-named patient only, for his or her treatment, and will not be sold or otherwise distributed and that no patient or third party (including, but not limited to, Medicare and any other governmental programs) shall be charged for such product. Additionally, no units of this investigational product will be submitted for Medicare, Medicaid, or any public or private third party reimbursement, or returned for credit. I understand eligibility under this program is subject to the American Regent Expanded Access Program’s approval and the patient’s continuing compliance with all eligibility requirements, as set by American Regent, Inc. I agree to allow the American Regent Expanded Access Program or its authorized agent(s) to review the medical, financial, and insurance records for this patient at any time for the purposes of verifying the patient’s eligibility status for the program and the patient’s receipt of any investigational product(s) provided to him or her through the program.