Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015, or later

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1. Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use UB-04 Data only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of UB-04 Data is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this Agreement. You acknowledge that the AHA holds all copyright, trademark, and other rights in UB-04 Data. You shall not remove, alter, or obscure any AHA copyright notices or other proprietary rights notices included in the materials.
   
2. Any use not authorized herein is prohibited, including, by way of illustration and not by way of limitation, making copies of UB-04 Data for resale and/or license, transferring copies of UB-04 Data to any party not bound by this agreement, creating any modified or derivative work of UB-04 Data, or making any commercial use of UB-04 Data. License to use UB-04 Data for any use not authorized herein must be obtained through the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois, 60606. Applications are available at the NUBC website, http://www.nubc.org/ http://www.nubc.org/.
   
3. The UB-04 Data included in this product is commercial technical data and/or computer databases and/or commercial computer software and/or commercial computer software documentation, as applicable, which was developed exclusively at private expense by the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois 60606. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2) (November 1995) and/or subject to the restrictions of DFARS 227.7202-1(a) (June 1995) and DFARS 227.7202-3(a) (June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.
   
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