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N OF 1 HEALTH RESEARCH PLATFORMTM TERMS OF USE


[Last Updated: March 2013]

Welcome to the N of 1 Health Research Platform ("the N of 1 Platform"), the web platform of Digital Infuzion, Inc. ("Digital Infuzion"). The N of 1 Platform incorporates both a reporting portal and a data entry component operated by Medidata Solutions, Inc. ("Medidata"). These Terms of Use govern the access to and use of the N of 1 Platform and are in addition to your acceptance of the Medidata terms of use required to access the data entry component of the N of 1 Platform.

The N of 1 Platform is for use by physicians and authorized medical personnel (the "Participating Medical Personnel") and patients ("Patients") who take part in registries, observational studies, or health outcome studies sponsored by Digital Infuzion's customer ("Customer"), as well as members of secondary care teams that provide care for Patients ("Secondary Care Personnel") (collectively, "Users").

The N of 1 Platform is restricted-access: in accordance with these Terms of Use, only Participating Medical Personnel who are approved by Customers of Digital Infuzion, and Secondary Care Personnel and Patients who are invited by Participating Medical Personnel, may register to access and use the N of 1 Platform. Registration for and use of the N of 1 Platform by Users is entirely voluntary.

The primary purpose of the N of 1 Platform is to facilitate, in accordance with the Customer's observational outcomes or other study protocols, Participating Medical Personnel to collect, submit, and view data in connection with these studies. Participating Medical Personnel will have the ability to view pre-defined, real-time reports from this data and to share such individual reports with Secondary Care Personnel and Patients. Each class of User has different rights in relation to the N of 1 Platform:

Participating Medical Personnel may enter data on the N of 1 Platform, review and query data stored on the N of 1 Platform, and generate reports from the N of 1 Platform;

Secondary Care Personnel may review reports relating to Patients, but only if published and shared by Participating Medical Personnel; and

Patients may review customized reports generated and shared by Participating Medical Personnel and may view a list of Observational outcomes members who are part of the Participating Medical Personnel's team.

Accordingly, these Terms of Use are divided into sections applicable to different classes of User.


Terms Regarding Use of the N of 1 Platform Applicable to All Users

Use of the N of 1 Platform. Access and use of the N of 1 Platform is subject to these Terms of Use . By registering for and using the N of 1 Platform, 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. If you do not agree to these Terms of Use, you may not register for, access or use the N of 1 Platform. Digital Infuzion may modify these Terms of Use at any time, at its discretion and without notice, and modifications are effective upon being posted on the N of 1 Platform. You are responsible for reviewing these Terms of Use periodically to ensure that you are fully informed of any changes to them.

Digital Infuzion's Use of Information Stored in the N of 1 Platform. You acknowledge and agree that Digital Infuzion and its Customer may access and use information that is entered into and/or stored in the N of 1 Platform in accordance with guidelines and restrictions set out in the observational outcomes protocols. Digital Infuzion and its Customer reserve the right to monitor all and any data that are entered into the N of 1 Platform and to correct data in accordance with study data review standard operating procedures.

Indemnification. You agree to indemnify, defend and hold harmless Digital Infuzion, its Customer, and any of their 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 any violation by you of these Terms of Use, including, without limitation, the submission of any inaccurate or incorrect information or information whose submission is in breach of applicable data privacy or other applicable laws.

Use of the N of 1 Platform by Participating Medical Personnel and Secondary Care Personnel. You are solely responsible for your use of the information stored in or generated from the N of 1 Platform, including, but not limited to, any and all course of action, clinical or medical decisions or treatment protocols using any information in or from the N of 1 Platform. Any record generated from the N of 1 Platform shall not function as a medical record for any Patient; under no circumstances should such records or reports be considered as replacements of or substitutions for a medical record of any Patient.

Data Privacy and Data Protection. The operation of the N of 1 Platform is subject to applicable European, United States, and other data privacy laws. Some Patient information that Participating Medical Personnel enter into the N of 1 Platform may constitute protected personally identifiable information, or personal data, under such laws. In addition to obtaining consents from Patients in accordance with Section 10 herein below ("Third Party Consents"), before using the N of 1 Platform and entering any data into the N of 1 Platform, Participating Medical Personnel must familiarize themselves with any legal obligations and responsibilities applicable to them arising from applicable data privacy or related laws. Digital Infuzion will not be held responsible for any loss, harm or damage arising from or related to the failure of Participating Medical Personnel to abide by any such obligations and responsibilities. Digital Infuzion has taken appropriate measures to ensure that its processing of any personal data complies with applicable data privacy laws, including by adopting appropriate technological and organizational measures to ensure the security and confidentiality of any personal data that are stored on the N of 1 Platform. Data submitted to the N of 1 Platform will be encrypted using web security best practices. All Users who have access to Patient clinical data must be approved by the Digital Infuzion Customer and/or the Participating Medical Personnel managing a patient. All data will be stored in a secure third-party hosting facility.

Terms Regarding Registration Applicable to All Users

Registration and Privacy. Information that you provide to Digital Infuzion and its Customer about yourself when registering to use the N of 1 Platform must be accurate and truthful, and you accept any and all liability for any inaccurate or untruthful information that you provide, except that Patients may register with a fictitious name (or alias) in order to protect their privacy. Note that Secondary Care Personnel and Patients will need a valid e-mail address in order to register, as invitations will be sent from Participating Medical Personnel via e-mail, which will contain a personalized link for the invitee to click on in order to register. Accordingly, Digital Infuzion, the primary technical provider, and its agents, will have access to the e-mail addresses for all Users for the purpose of assistance with passwords and for the sending of system notification updates. Digital Infuzion respects the privacy of all Users, and you should refer to the Digital Infuzion Privacy Policy applicable to the N of 1 Platform to learn more about the collection and use of your personal information.

User Account, Password and Security. All Users, regardless of role, must register and select a username, password, and a security question. You are entirely responsible for maintaining the confidentiality of your ID, password and account, and for taking precautions to prevent the inadvertent disclosure of your ID, password or account information. Furthermore, you should not share your user ID or password, even with other members of your staff or practice (for Participating Medical Personnel and Secondary Care Personnel) or with family members or friends (for all Users). For Participating Medical Personnel and Secondary Care Personnel, each member of your staff or practice will need to be separately enrolled in the N of 1 Platform and obtain his/her own user ID and password. You are entirely responsible for any and all activities that occur under your account. You agree to notify Digital Infuzion immediately of any unauthorized use of your account or any other breach of security. Digital Infuzion will not be liable for any loss that you may incur as a result of someone else using your ID, password or account, either with or without your knowledge. You may be held liable for any harm or loss (including legal fees) incurred by Digital Infuzion or another party due to someone else using your ID, password or account. Digital Infuzion and its customer may suspend or terminate your access to the N of 1 Platform if Digital Infuzion believes your account is being used by an unauthorized person or if you have not complied with these Terms of Use or for any other reason in Digital Infuzion's sole discretion. You may not use anyone else's account at any time, without the express permission of the account holder.

E-signatures. In order to become authorized to use the N of 1 Platform, you may be asked to furnish information that constitutes an electronic signature. You accept that your electronic signature is legally binding and equivalent to your written signature.

Terms Regarding Use Applicable to Participating Medical Personnel

Information Entered into the N of 1 Platform by Participating Medical Personnel. You may only enter information into the N of 1 Platform that relates to the studies, and you accept any and all liability for any optional information that you enter, for example, care team contacts or report comments. You are prohibited from entering any information that may breach applicable laws, including any data protection or privacy laws; Sections 5 ("Data Privacy and Data Protection") and 10 ("Third Party Consents") of these Terms of Use set out your obligations in this regard in more detail.

Third Party Consents. You may enter into the N of 1 Platform personal information relating to a Patient only after securing the freely-given explicit consent of the Patient to do so. Please note, in some jurisdictions including potentially your own, observational outcomes identification numbers might constitute personal information under applicable laws. When obtaining such consents, you must comply with any requirements arising under their local data privacy, health or related laws. This includes obtaining the Patient's written consent and providing Patients with suitable informational disclosures concerning the processing of their data in connection with the N of 1 Platform. It is a misuse of the N of 1 Platform and a violation of these Terms of Use to enter information relating to a Patient who has not expressly consented to having their personal data processed in connection with the N of 1 Platform. You are solely responsible for any and all information entered by you regarding Patients, and in no event shall Digital Infuzion be liable for any loss, harm or damage arising from or related to your failure to obtain necessary consents from Patients to have information relating to them entered into or processed in connection with the N of 1 Platform.

Responsibility for Secondary Care Personnel and Patient use of the N of 1 Platform. As a Participating Medical Personnel, you have the ability at your discretion to invite Secondary Care Personnel and your Patients to enroll in the N of 1 Platform. Secondary Care Personnel and Patients will only have access to customized reports specifically created and designated by you. You are solely responsible for verifying the identity of such invitees and for the disclosure of the Patient data to Secondary Care Personnel and to the Patients themselves, including any liability related to the disclosure of such data to the extent disclosure is not permissible under local law. For system performance, Digital Infuzion and its Customer may monitor access to particular Patient data stored on the N of 1 Platform by user ID and may perform audits on such access.

Exclusion of Liability. Any information and material entered by Participating Medical Personnel into the N of 1 Platform is done at your own discretion and risk and you will be solely responsible for any damage to your computer system or loss, temporary or permanent, of data that results from the input of any such information or material or otherwise from using the N of 1 Platform.

Disclaimers, Exclusions and Other Important Terms Applicable to All Users

Disclaimer of Warranties. The N of 1 Platform is provided on an "AS IS" and "AS AVAILABLE" basis. You agree that your access to and use of the N of 1 Platform and the contents available therein is at your own risk.

Although Digital Infuzion will use reasonable efforts to ensure that the N of 1 Platform remains operational and accessible to Users, by registering for and using the N of 1 Platform you accept that Digital Infuzion makes no express or implied warranties or representations of any kind as to the accuracy, content, completeness, reliability, operability, or legality of information contained within the N of 1 Platform; or that the N of 1 Platform will meet your particular business requirements, needs or expectations; or that the N of 1 Platform will be uninterrupted, timely, error-free or continuously available; or that the N of 1 Platform 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).

Damages. Any use that you make of information stored within the N of 1 Platform or generated in reports is done at your own discretion and risk. Neither Digital Infuzion, nor any party involved in creating, producing or delivering the N of 1 Platform, shall be liable 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 access to, use of or inability to use the N of 1 Platform, or regarding any use of information stored within the N of 1 Platform or generated in reports.

Non-Confidential Information. Subject to any protections that might be extended under the Digital Infuzion Privacy Policy applicable to the N of 1 Platform, any communication that you send to Digital Infuzion via the Internet is and will be deemed to be non-confidential and Digital Infuzion shall have no obligation of any kind with respect to such information, except as contained in the applicable observational outcomes protocol. Digital Infuzion shall be free to use any ideas, concepts, know-how or techniques contained in such communication for any purpose whatsoever, including but not limited to, researching, developing, testing, manufacturing and marketing products.

Trademarks. All product names with or without the trademark symbol, are registered trademarks, trademarks or trade names of Digital Infuzion, its Customers, affiliates, related companies, licensors or joint venture partners, unless otherwise noted. The use of these trademarks or any other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law or other proprietary rights of Digital Infuzion.

Copyrights. The contents of the N of 1 Platform are subject to copyright protection and all rights therein are reserved to Digital Infuzion. The contents of the N of 1 Platform may not be copied other than for non-commercial individual reference with all copyright or other proprietary notices retained, and thereafter may not be recopied, reproduced or otherwise redistributed except where necessary in connection with your professional activities and related research endeavors. 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 Digital Infuzion. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of Digital Infuzion, or any third party.

Void Where Prohibited. The N of 1 Platform 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 and its Customer reserve the right to limit use of the N of 1 Platform to any person, geographic region or jurisdiction.

Third Party Web Sites. The N of 1 Platform contains links to other World Wide Web sites and resources produced by Digital Infuzion and its Customers various operating divisions and affiliates, as well as independent third parties unaffiliated with Digital Infuzion. Such links are provided for your reference only. Digital Infuzion does not control such web sites, and is not responsible for their contents. Digital Infuzion's inclusion of links to such web sites does not imply any endorsement of the material on such web sites or any association 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. Digital Infuzion makes no representation or warranty as to any third party content, products or services, and you agree that Digital Infuzion 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 web site, you should read that web site's privacy policy before disclosing any personal information.

Software Use. Use of the N of 1 Platform may entail your installing, copying, downloading, accessing or otherwise using software products owned by or proprietary to Digital Infuzion or its licensors (the "Software"). Users are authorized to install, use, access, display or run the Software only in connection with their use of the N of 1 Platform, 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, Digital Infuzion and its Customer may revoke your right to use the Software if you do not abide by the terms and conditions contained in this Section 20 ("Software Use").

Governing Law and Jurisdiction. These Terms of Use shall be governed by the laws of the State of Maryland, United States, without regard to its conflicts of laws principles. Any legal action or proceeding related to the N of 1 Platform shall be brought exclusively in a court of competent jurisdiction sitting in Montgomery County, State of Maryland, United States.

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

The N of 1 Platform Transferability. Digital Infuzion and its Customer retain various technology partners to operate the N of 1 Platform system on its behalf. These include Digital Infuzion, Inc. and Medidata Solutions, Inc., who maintain secure hosting services. Digital Infuzion also reserves the right to sell, assign or otherwise transfer operation and control of the N of 1 Platform or any individual observational outcomes to a third party at some future point in time.

Contact Details. If you are a Participating Medical Personnel or Secondary Care Personnel and have questions about your use of the N of 1 Platform, please write to us via email. If you are a patient, we recommend that you contact your treating physician who participates in the observational outcomes studies.