The GNE Myopathy – Disease Monitoring Program at https://www.gnem-dmp.com/ or its successor site is the Online Registry (“GNEM-DMP Online Registry”) for a clinical study under the Protocol GNE-Myopathy Disease Monitoring Program (GNEM-DMP): A Registry and Prospective Observational Natural History Study to Assess GNE Myopathy or Hereditary Inclusion Body Myopathy (HIBM) (the “Study”), which is sponsored by Ultragenyx Pharmaceutical Inc. (“Ultragenyx”). Further information about the Study is available at https://clinicaltrials.gov.
The GNE Myopathy – Disease Monitoring Program is supported by an academic and industry partnership between TREAT-NMD and Ultragenyx. TREAT-NMD is located in England, and Ultragenyx has its headquarters in the United States with affiliates, subsidiaries, and partners around the world. TREAT-NMD is responsible for curating the GNEM-DMP Online Registry. The GNEM-DMP Online Registry, a restricted-access website, is operated by Digital Infuzion, Inc. (“DIFZ”). DIFZ is headquartered and has its operations in the United States. The platform and data storage operated by DIFZ are located in the United States.
Your Use of the Information and Data at the GNEM-DMP Online Registry
You are solely responsible for your use of the information or data stored in or generated from the GNEM-DMP Online Registry (“GNEM-DMP Online Registry Information”), including, but not limited to, any and all course of action, clinical or medical decisions or treatment protocols using any GNEM-DMP Online Registry Information. Any record generated from the GNEM-DMP Online Registry shall not function as a medical record and under no circumstances should such records or reports be considered as replacements of or substitutions for a medical record of yours.
Registration and Accuracy of Your Information and Data
After you register and your registration is validated, in order to be able to participate in the Study, you will need to sign or electronically sign the Informed Consent Form, which will be available to you after your registration is complete.
User Account, Password and Security
You must register and select a username, password, and a security question. You are entirely responsible for maintaining the confidentiality of your username, password and account, and for taking precautions to prevent the inadvertent disclosure of your username, password or account information. You are entirely responsible for any and all activities that occur under your account.
- In any manner that violates any applicable federal, state, local and international law or regulation;
- To gather or attempt to gather personal information belonging to other users without their consent;
- In any manner that could disable, overburden, damage, or impair the GNEM-DMP Online Registry or interfere with any other party's use of the GNEM-DMP Online Registry, including their ability to engage in real time activities through the GNEM-DMP Online Registry;
- To engage in any other conduct that restricts or inhibits anyone's use or enjoyment of the GNEM-DMP Online Registry, or which may harm DIFZ, Ultragenyx, TREAT-NMD, or other users of the GNEM-DMP Online Registry, or may expose DIFZ, Ultragenyx, TREAT-NMD, or other users of the GNEM-DMP Online Registry to liability;
- To use any robot, spider or other automatic device, process, or means to access the GNEM-DMP Online Registry for any purpose, including to monitor or copy any of the material on the GNEM-DMP Online Registry;
- To use any manual process to monitor or copy any of the content on the GNEM-DMP Online Registry for any unauthorized purpose;
- To use any device, software, or routine that interferes with the proper working of the GNEM-DMP Online Registry;
- Introduce any viruses, Trojan horses, worms, logic bombs, or other material which is malicious or technologically harmful;
- To attempt to gain unauthorized access to, interfere with, damage, or disrupt any part of the GNEM-DMP Online Registry, the server on which any part of the GNEM-DMP Online Registry is stored, or any server, computer, or database connected to the services;
- To attack the GNEM-DMP Online Registry via a denial-of-service attack or a distributed denial-of- service attack; or
- Otherwise to attempt to interfere with the proper working of the GNEM-DMP Online Registry.
If you violate these Prohibit Use, DIFZ may suspended your access to the GNEM-DMP Online Registry.
Disclaimers, Exclusions and Other Important Terms
Disclaimer of Warranties. The GNEM-DMP Online Registry is provided on an "AS IS" and "AS AVAILABLE" basis.
Although DIFZ will use reasonable efforts to ensure that the GNEM-DMP Online Registry remains operational and accessible to you, DIFZ makes no express or implied warranties or representations of any kind as to the accuracy, content, completeness, reliability, operability, or legality of GNEM-DMP Online Registry Information; or that the GNEM-DMP Online Registry will meet your particular business requirements, needs or expectations; or that the GNEM-DMP Online Registry will be uninterrupted, timely, error-free or continuously available; or that the GNEM-DMP Online Registry will not cause you any loss, interruption of business, interruption of research or treatment, or any direct, indirect, special, incidental or consequential damages of any kind (including lost profits) regardless of the form of the action whether in contract or in tort (including negligence).
Neither Ultragenyx nor TREAT-NMD make any representations or warranties whatsoever about the GNEM-DMP Online Registry Information.
Trademarks. All product names with or without the trademark symbol, are registered trademarks, trademarks or trade names of DIFZ, Ultragenyx, and TREAT-NMD or their respective affiliates, related companies, licensors or joint venture partners, unless otherwise noted. The use of these trademarks or any other materials is expressly prohibited and may be in violation of copyright law, trademark law or other proprietary rights of DIFZ, Ultragenyx, or TREAT-NMD.
Copyrights & Developments. Solely as between you and DIFZ, the content of the Webpages of the GNEM-DMP Online Registry (“Webpages”) are subject to copyright protection and all rights therein are reserved to DIFZ. The Webpages may not be copied other than for non-commercial individual reference with all copyright or other proprietary notices retained. Except as expressly provided above, you may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text or documents or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text or documents, without the express written consent of DIFZ. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of DIFZ, Ultragenyx, or TREAT-NMD or any third party.
Your responses to questions, patient reported outcomes, or other data, which you provide for the Study, provided by you at the GNEM-DMP Online Registry (“Study Data”) and any derivatives thereof, such as results, reports, aggregated data, and other derivative material belong solely to Ultragenyx. You will not be compensated in any way for any new developments, whether or not patentable, which are related to or arise from content provided by you to the GNEM-DMP Online Registry. By registering for the GNEM-DMP Online Registry, you hereby assign any such rights, title, or interest in the Study Data and derivatives thereof or developments therefrom to Ultragenyx.
Software Use. Use of the GNEM-DMP Online Registry may entail your installing, copying, downloading, accessing or otherwise using software products owned by or proprietary to DIFZ or its licensors (the "Software"). You are authorized to install, use, access, display or run the Software only in connection with their use of the GNEM-DMP Online Registry, and for no other purpose. You may not reverse engineer, decompile, or disassemble the Software. You may not nor permit others to copy or transfer the Software; distribute, sell, rent, loan, lease, sub-license or otherwise deal in the Software; alter, adapt, merge, modify or translate the Software in any way or for any purpose, including, without limitation, for error correction; remove, change or obscure any product identification or notices of proprietary rights and restrictions on or in the Software. Without prejudice to any other rights it may have, DIFZ may revoke your right to use the Software if you do not abide by this Section Software Use.
Assumption of Risk. You understand, acknowledge, and agree that the GNEM-DMP Online Registry is intended solely intended to increase understanding of your disease, is part of the Study (which means that information and data here is experimental and investigatory in nature and therefore should not be relied upon in any way in making any decisions whatsoever about you or one you care for), and that you should be under the care of a physician to treat your disease. The GNEM-DMP Online Registry is not intended to provide you medical advice of any kind or to be a substitute for medical professional. Any use by you of GNEM-DMP Online Registry Information is done solely at your own discretion and risk.
Limitation of Liability. NONE OF THE GNEM-DMP ONLINE REGISTRY PARTIES SHALL BE LIABLE, JOINTLY OR SEVERALLY, FOR ANY DAMAGES, INCLUDING WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND (INCLUDING LOST PROFITS) REGARDLESS OF THE FORM OF THE ACTION WHETHER IN CONTRACT OR IN TORT (INCLUDING NEGLIGENCE), ARISING OUT OF YOUR ACCESS TO, USE OF, OR INABILITY TO USE EITHER THE GNEM-DMP ONLINE REGISTRY OR THE GNEM-DMP ONLINE REGISTRY INFORMATION, UNLESS SUCH DAMAGES ARE SOLELY RELATED TO THE STUDY AND THE INFORMED CONSENT FORM OBLIGATES ULTRAGENYS TO BE LIABLE FOR SUCH DAMAGES.
Void Where Prohibited. The GNEM-DMP Online Registry and its contents are intended to comply with the laws and regulations of the State of Maryland, United States. Other countries may have laws, regulatory requirements and medical practices that differ from those in the State of Maryland, United States.
Digital Infuzion, Inc.
656 Quince Orchard Road, Suite 300
Gaithersburg, MD 20878
The John Walton Muscular Dystrophy Research Centre, Newcastle University, International Centre for Life, Newcastle upon Tyne
T: 0191 241 8905