GNEM-DMP Terms of Use

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.

Applicability of Terms of Use and the Privacy Policy to the GNEM-DMP Online Registry
Access and use of the GNEM-DMP Online Registry is subject to these Terms of Use. By registering for and using the GNEM-DMP Online Registry, you accept, without limitation or qualification, these Terms of Use and you acknowledge that you have read, understood and agree to these Terms of Use, along with the Privacy Policy, which explains what personal data will be collected, how that data will be used, and what protections are in place for that data collected, stored, or otherwise processed and which is incorporated by reference in its entirety.

If you do not agree to these Terms of Use or the Privacy Policy, you may not use the GNEM-DMP Online Registry. DIFZ in collaboration with TREAT-NMD reserves the right to limit use of the GNEM-DMP Online Registry to any person, geographic region, or jurisdiction.

DIFZ may modify these Terms of Use or the Privacy Policy at any time, at its discretion and without notice, and modifications are effective upon being posted on the GNEM-DMP Online Registry Terms of Use page. You will be asked to review and affirmatively agree that you have read and understood the Terms and Policy.

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
When registering (i.e., creating an account or profile), you must provide accurate and truthful information, and you accept any and all liability for any inaccurate or untruthful information that you provide. You will need a valid e-mail address in order to register, because invitations to complete registration and to begin the consent process will be sent via e-mail, which will contain a personalized link for the you to click on in order to complete registration. DIFZ, its agents, and TREAT-NMD will have access to the e-mail addresses in order to contact you for the purposes in the Privacy Policy.

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.

You agree to notify DIFZ and TREAT-NMD (see bottom of these Terms of Use) immediately of any unauthorized use of your account or any other breach of security. None of the parties supporting the Study or GNEM-DMP Online Registry, namely DIFZ, Ultragenyx, or TREAT-NMD (“GNEM-DMP Online Registry Parties”), will be liable jointly or severally for any loss that you may incur as a result of someone else using your username, password or account, either with or without your knowledge.

Prohibit Uses
You may use the GNEM-DMP Online Registry only for lawful purposes and in accordance with these Terms of Use. You agree not to use the GNEM-DMP Online Registry:

  • In any manner that violates any applicable federal, state, local and international law or regulation;
  • To send, knowingly receive, upload, download, use or re-use any material which does not comply with these Terms of Use;
  • 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.

Third Party Web Sites.  The GNEM-DMP Online Registry contains links to other websites and resources. Such links are provided for your reference only. The GNEM-DMP Online Registry Parties do not necessarily control such websites and use of those websites is governed by the terms of the use of those websites. DIFZ's inclusion of links to such websites does not imply any endorsement by the GNEM-DMP Online Registry Parties of the material on such websites or any association of the GNEM-DMP Online Registry Parties with their operators, and your access and use of such web sites, including information, material, products and services therein, is solely at your own risk. No GNEM-DMP Online Registry Party makes any representation or warranty as to any third party content, products or services, and you agree that none of the GNEM-DMP Online Registry Parties shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such third-party content, products or services available on or through any such site or resource. Once on another website, you should read that website's terms of use and Privacy Policy before disclosing any personal information.

Indemnification.  You agree to indemnify, defend, and hold harmless, individually or jointly, any GNEM-DMP Online Registry Party and any of their respective affiliated companies, officers, directors, employees, agents, suppliers, and third-party partners from and against all losses, expenses, damages and costs, including reasonable attorneys' fees, resulting from or arising out of: (i) any violation by you of these Terms of Use, including, without limitation, the submission of any inaccurate or incorrect information or the submission of information that breaches any applicable data privacy or other applicable laws; (ii) your use of the Webpages or the GNEM-DMP Online Registry Information; or (iii) the use by another of your username, password, and/or account.

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.


Governing Law and Jurisdiction.  These Terms of Use and the Privacy Policy shall be governed by the laws of the State of New York, USA, without regard to its conflicts of laws principles. Any legal action or proceeding related to or arising from your use of the GNEM-DMP Online Registry shall be brought exclusively in a court of competent jurisdiction sitting in New York, New York, USA. You hereby agree to and waive any objection to such venue and jurisdiction.

Severance.  If any provision of these Terms of Use or the Privacy Policy is held to be unlawful, void or unenforceable, then such provision shall be severable without affecting the enforceability of all remaining provisions.

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.

Contact Information:

Digital Infuzion, Inc.
656 Quince Orchard Road, Suite 300
Gaithersburg, MD 20878
E:  nof1support@digitalinfuzion.com

Phillip Cammish
The John Walton Muscular Dystrophy Research Centre, Newcastle University, International Centre for Life, Newcastle upon Tyne
E:  phillip.cammish@ncl.ac.uk
T:  0191 241 8905