Open Research Exchange (ORE) Platform Agreement

Background

Access to the ORE Platform, and the Patient-Reported Outcome tools and questionnaires in the ORE Platform, is being made available to You by PatientsLikeMe, Inc. (“PatientsLikeMe”) under the below terms and conditions of this Agreement. A “Patient-Reported Outcome” or “PRO” is a questionnaire that is designed for individuals to complete and that, based on a patient’s response to the questionnaire, measures some aspect of the patient’s health. PROs consist of a series of questions that permit patient responses within a defined scope of possible answers, with the responses to questions scored on a scale designed to measure health status, quality of life, health-related quality of life, symptomology, impairment from disease, well-being, or other health-related concepts.

In addition to making the ORE Platform available online to researchers such as Yourself, PatientsLikeMe develops, markets and maintains a website at www.patientslikeme.com that collects from its members, and shares with other patients and third parties, real world, patient-reported outcomes data in various diseases and conditions, with designated groups of web pages on the website devoted to persons who are suffering from a specific disease or condition and who have registered as members of such community (each a “Community” and such members “Community Members”) (collectively, together with any successor or replacement websites and Communities, the “PLM Website”);

1. PRO Authoring Tool.

(a) Creating and Modifying PROs. The ORE Platform includes a PRO authoring tool (the “PRO Authoring Tool”) that helps You create and modify PROs online, which PROs are then made freely and publicly available on the ORE Platform as described below. When using the PRO Authoring Tool, You may use as a starting template existing PROs that are made available in the ORE Platform’s PRO Library, manually input questions into the PRO Authoring Tool from an existing PRO that You created outside the ORE Platform (and to which You own any underlying rights), or start with a blank template.

(b) License to PatientsLikeMe to All PROs You Create or Modify Using, or Import into, the PRO Authoring Tool.

You hereby grant PatientsLikeMe an irrevocable license to use, modify, copy, display and distribute all PROs You create or modify using the PRO Authoring Tool, including but not limited to any PRO You import or input into the PRO Authoring Tool or ORE Platform, (collectively, “Resulting PROs”) under the terms of the Creative Commons Attribution-ShareAlike Version 3.0 United States license (the “ShareAlike License”), which license terms are set forth at: http://creativecommons.org/licenses/by-sa/3.0/us/, except as may conflict with any Third Party Licenses expressly identified by You in accordance with Section 1(c) below. For purposes of clarity, PatientsLikeMe’s license to the Resulting PROs is fully sub-licensable and transferable in accordance with the ShareAlike License terms.

You understand that, subject to any Embargo Period described below and any Third Party License terms identified by you in accordance with Section 1(c) below, PatientsLikeMe may use the Resulting PROs and distribute and make available the Resulting PROs to third parties (whether on the ORE Platform or through other means) in accordance with the terms of the ShareAlike License, and that such third parties shall similarly have the right to use and distribute the Resulting PROs in accordance with the ShareAlike License.

(c) Importing PROs into the PRO Authoring Tool and PRO Library. You agree that when you import or copy a PRO into the PRO Authoring Tool or ORE Platform:

  • (i) You shall have previously secured any necessary rights or permissions to import such PRO into the PRO Authoring Tool or ORE Platform necessary to comply with the terms of this Agreement;
  • (ii) if PRO was created outside of the ORE Platform or is a derivative work of a PRO created outside the ORE Platform, and if the PRO or the PRO of which it is a derviative work is subject to certain license terms imposed by the copyright or other owner (“Third Party License Terms”), then You shall (1) provide the correct and complete copy of such Third Party License Terms and (2) accurately answer any questions regarding the Third Party License Terms asked by the ORE Platform or PatientsLikeMe in connection with the importation of the PRO; and
  • (iii) if You have copied or based the PRO, or any part of the PRO, on a PRO in the PRO Library, then You shall have accurately indicated (in response to questions from the ORE Platform) from which PROs in the PRO Library the PRO has been copied or based.

You agree, represent, and warrant to PatientsLikeMe that if You import or copy any PRO into the PRO Authoring Tool or ORE Platform (other than from the PRO Library) that, unless expressly indicated in any Third Party License Terms that you provided the ORE Platform when importing such PRO, You have all rights necessary for You to grant PatientsLikeMe the right to redistribute the PRO under the terms of the ShareAlike License. You understand that PatientsLikeMe is relying on this representation, warranty and agreement in making Resulting PROs available under the ShareAlike License to other users of the ORE Platform and other third parties.

(d) PRO Library. The ORE Platform provides access to certain PROs created and owned by third parties, including but not limited to PROs made by other users of the ORE Platform using the PRO Authoring Tool (the “PRO Library”).

Many of the PROs in the PRO Library are made available to You under the terms of the ShareAlike License (http://creativecommons.org/licenses/by-sa/3.0/us) as expressly indicated in the PRO Library (“Open PROs”) and You may use such Open PROs, including but not limited to by printing copies of such Open PROs and using them outside of the ORE Platform, only in accordance with the terms of ShareAlike License. Other PROs in the PRO Library that were created outside of the ORE Platform are subject to certain additional Third Party License Terms as expressly indicated in the PRO Library (“Restricted PROs”). You agree to comply with the terms of such ShareAlike License with respect to all Open PROs from the PRO Library, and any derivative works You create of such Open PROs. Further, You agree to comply with the Third Party License Terms applicable to any Restricted PROs from the PRO Library, and any derivative works You create of such Restricted PROs. In addition, certain Restricted PROs may not permit the copying or creation of derivative works; if any Restricted PRO is labeled as being so restricted, You agree to comply with such restrictions.

You understand and acknowledge that PLM does not independently verify the ownership of the PROs included in the PRO Library, and that PatientsLikeMe is relying on the representations of (i) users such as Yourself who create or modify PROs using the ORE Platform and (ii) third parties who have supplied PROs created outside the ORE Platform when identifying on the ORE Platform a PRO as being available subject to the ShareAlike License or available subject to certain specified Third Party License Terms.

You agree that PatientsLikeMe shall not be responsible or liable should any PRO in the PRO Library infringe or violate the intellectual property or other rights of a third party, and that You use such PROs at your own risk.

2. Collection of Responses to PROs from Respondents; Importing Data/Responses You Have Separately Collected.

(a) Deploying PROs to Respondents through the ORE Platform. Through functionality contained in the ORE Platform, You may elect to have PatientsLikeMe solicit its Community Members to answer and respond to any Resulting PRO that You have created or any PRO from the PRO Library. Based on the criteria You provide to the ORE Platform, PatientsLikeMe will determine in its sole discretion which Community Members (if any) to invite to respond to the PRO You have selected for solicitation of responses (a “Deployed PRO”). You acknowledge that Community Members are not obligated to respond to any PRO and that PatientsLikeMe and the ORE Platform does not verify the accuracy or truthfulness of their responses if they do respond. The ORE Platform refers to a Deployed PRO as a session or a study, which comprises the fielding of a specific version of a PRO to PatientsLikeMe’s Community Members according to specified selection criteria. For purposes of clarity, separate fieldings of the same PRO requested by You at different points in time shall constitute separate Deployed PROs.

(b) Your Use and Disclosure of Member Responses. PatientsLikeMe will collect responses from Community Members to Your Deployed PRO (“Member Responses”) and make such Member Responses available for You to review via the ORE Platform. While You are free to use and disclose Member Responses, You agree that You will not disclose Member Responses without first de-identifying such Member Responses, as defined by the medical privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996, 45 C.F.R. Section 164.514 (b)(2).

(c) PatientsLikeMe’s Use and Disclosure of Member Responses. PatientsLikeMe collects Member Responses to Deployed PROs from Community Members under the terms of PatientsLikeMe’s Privacy Policy (www.patientslikeme.com/about/privacy) and Terms and Conditions of Use (www.patientslikeme.com/about/user_agreement) then in effect with its Community Members. Member Responses are “Shared Data” under PatientsLikeMe’s Privacy Policy. Subject to any Embargo Period (as described below), PatientsLikeMe may make Member Responses available to all users of the ORE Platform, to its partners or other third parties, and/or publicly available. During any Embargo Period, the Member Responses shall not be made available by PatientsLikeMe to anyone except to You, any collaborators You have expressly instructed the ORE Platform should have access to Member Responses, and, with respect to each Community Member’s Member Response, the actual Community Member who responded.

(d) Profile Data. PatientsLikeMe may provide You with certain de-identified background profile data about Community Members who respond to Your Deployed PRO, which may include, in PatientsLikeMe’s sole discretion, the age, gender, and relevant health data of the responding Community Member for purposes of allowing You to better filter and evaluate Member Responses (“Profile Data”).

(e) Uploading Respondent Data Collected by You Outside of the ORE Platform. You may elect to field copies of PROs to individuals outside of the ORE Platform, and then upload or input their responses into the ORE Platform (“Researcher Submitted Responses”). If You elect to upload or input Research Submitted Responses into the ORE Platform, then You agree that, subject to any Embargo Period (as described below), PatientsLikeMe shall be free to use and disclose to other users of the ORE Platform and other third parties such Researcher Submitted Responses the same as if they were collected from actual Community Members as Member Responses. You covenant, represent, and warrant that, prior to uploading or inputting any Researcher Submitted Responses into the ORE Platform, You will obtain all necessary consents and waivers from the PRO respondents who supplied such Research Submitted Responses in order for You to be able to deliver to PatientsLikeMe the Researcher Submitted Responses on the terms described in this paragraph and in compliance with all applicable privacy, healthcare, and other laws.

(f) Embargo Period. PatientsLikeMe aims to support a public discourse around research, and in support of that aim may publish, in anonymized or aggregated form, any response data collected in the fielding of a Deployed PRO via the ORE Platform. PatientsLikeMe also wishes, however, to support researchers in publishing findings in scientific journals and other media. Because some of these publication venues will not publish research based on data that has been previously published elsewhere, the ORE Platform may offer You the option to require PatientsLikeMe to delay making Member Responses and Researcher Submitted Responses available to other users of the ORE Platform and to PatientsLikeMe’s partners and other third parties for a designated period (the “Embargo Period”). This option may be offered in the ORE Platform at the time that you request deployment of a PRO to PatientsLikeMe Community Members, or it may be arranged in communication with PatientsLikeMe (subject to PatientsLikeMe’s approval). Each Deployed PRO may have a distinct Embargo Period, and the creation or extension of an Embargo Period for one Deployed PRO does not automatically apply or extend any Embargo Periods associated with other

Deployed PROs. During the Embargo Period associated with a particular Deployed PRO, PatientsLikeMe will not display or distribute Member Responses and Researcher Submitted Responses associated with that Deployed PRO except to You and collaborators you have authorized. PatientsLikeMe may change the embargo terms offered to new PRO deployments at any time; if you cannot accept the terms, you should not initiate a new Deployed PRO. You agree to use the embargo functions only to support good faith publication attempts, and not to delay release of data for other reasons.

(g) No Re-Identification of Member Responses or Profile Data. You shall in no event, either directly or indirectly through an agent or otherwise, identify or attempt to identify the Community Member source of any Member Responses or Profile Data, or to whom such data applies, including by matching any such data with other data in a manner that would enable You or any other party to identify the subjects of any Member Responses or Profile Data.

(h) Additional Restrictions on Use of Deployed PROs and Member Responses. You agree that you will not use the ORE Platform or any other technology or service provided by PLM pursuant to this Agreement to carry out any activity that would render PLM a “business associate” of a covered entity, as those terms are used in the HIPAA Privacy Regulations. You agree that before using the ORE Platform or any other technology provided by PLM pursuant to this Agreement to carry out research on human subjects, you will comply with all applicable laws, with the policies of any institution participating in such research, and the terms of any grant funding such research.

3. Use of ORE Platform.

PatientsLikeMe makes no warranties or guarantees that the ORE Platform will be continuously available or that access will uninterrupted or error free. In addition, PatientsLikeMe and its service providers may perform scheduled or unscheduled maintenance on its computer network making access to the ORE Platform, PROs, Member Responses, Profile Data, and other content and data on the ORE Platform unavailable during such maintenance periods. You shall be solely responsible for Your Internet connection, including all Internet service provider charges, and for having a Web browser and other software compatible with the ORE Platform.

You are responsible for maintaining the confidentiality of Your password and login, and are fully responsible for all activities that occur under Your password or account with or without Your knowledge. If You knowingly provide Your login and password information to another person, Your access to the ORE Platform may be suspended temporarily or terminated, in PatientsLikeMe’s sole discretion. You agree to immediately notify PatientsLikeMe of any unauthorized use of Your password or login or any other breach of security. You may only access the ORE Platform by logging in with Your correct login and password as permitted by the functionality of the ORE Platform. You shall not copy, modify, reverse engineer, nor interfere with the ORE Platform or PatientsLikeMe’s computer systems.

PatientsLikeMe may provide You from time to time an application programming interface (the “ORE API”) to facilitate the development of third-party software using resources available in the ORE Platform. If You use such ORE API, You agree to use the ORE API in accordance with rules and guidelines published in the online API documentation and with the separate license terms included with or referred to by such ORE API.

Excluding authorized use of the ORE API, You may not use any robot, spider, scraper, or other automated means to access the ORE Platform or content or services provided on the ORE Platform for any purposes. You may not post content on the ORE Platform that contains any viruses, Trojan horses, worms, time bombs, spiders, or other computer programming routines that are intended to damage, detrimentally interfere with, surreptitiously intercept or expropriate any system, data or personal information. You shall not attempt to make the ORE Platform unavailable through denial-of-service attacks or similar means. You shall not use contact information provided by Community Members in any Member Responses, or collect information about our Community Members, to contact Community Members or enable others to contact Community Members.

4. Termination of Your Access to the ORE Platform.

You agree that PatientsLikeMe may, with or without cause, immediately terminate or limit Your access to the ORE Platform (including all content and data hosted on the ORE Platform) without prior notice. Without limiting the foregoing, the following may lead to a termination by PatientsLikeMe of Your access and use of the ORE Platform: (a) breaches or violations of this Agreement or other incorporated agreements or guidelines, (b) a request by You (self-initiated termination), (c) unexpected technical issues or problems, (d) extended periods of inactivity, or (e) PatientsLikeMe’s decision to close public or free access to the ORE Platform. PatientsLikeMe has no obligation to maintain, store, or transfer to You Resulting PROs, Member Responses, Profile Data, Researcher Submitted Responses, or other information or data that You have posted on or uploaded to the ORE Platform.

5. Privacy.

You agree that You have read, understood and accept PatientsLikeMe's ORE Platform Privacy Policy (link). This policy explains PatientsLikeMe's collection of personal and non-personal information from You when using the ORE Platform and its use of and sharing of such personal and non-personal information. This policy does not govern: (i) PatientsLikeMe’s collection of Member Responses or Profile Data from Community Members, which is governed by PatientsLikeMe’s separate privacy policy with its Community Members (www.patientslikeme.com/about/privacy) or (ii) Researcher Submitted Responses which is governed by Section 2(e) above.

6. PatientsLikeMe Intellectual Property; Confidential Information.

PatientsLikeMe and its licensors are the sole owners of ORE Platform and of all copyright, trade secret, patent, trademark and other intellectual property rights in and to the ORE Platform, and this Agreement does not provide You with the title to or ownership of ORE Platform, but only a right of limited remote use under the terms and conditions of this Agreement. You acknowledge that non-public information regarding the design, performance, functionality and use of the ORE Platform, including but not limited to as contained in any documentation provided by PatientsLikeMe or its agents in connection therewith are the confidential information of PatientsLikeMe. You agree not to disclose such information to any other person or entity and not to use such information except to enable You to use the ORE Platform in accordance with the terms of this Agreement. All rights not expressly granted to You are reserved by PatientsLikeMe and its licensors and providers.

7. Disclaimers of Warranty; Limitation of Liability.

The ORE Platform, the Resulting PROs, the PRO Library, the Member Responses, Profile Data, and other content and services made available on the ORE Platform are provided on an “as is” and “as available” basis. PatientsLikeMe does not make and disclaims all express and implied warranties and representations, including, but not limited to, any implied warranty of fitness for a particular purpose or non-infringement of intellectual property rights, with regard to the ORE Platform, the Resulting PROs, the PROs in the PRO Library, Member Responses, Profile Data, or any services provided through the ORE Platform to the extent permitted by law.

In addition, PatientsLikeMe expressly disclaims any warranty that (a) access to the ORE Platform, Resulting PROs, the PRO Library, Member Responses, Profile Data, or other content or services on the ORE Platform will be uninterrupted or error-free or that defects will be corrected; or (b) the PROs included in the PRO Library do not infringe or violate the intellectual property rights of a third party or that the ShareAlike License and Third Party License Terms indicated by PatientsLikeMe as applying to the PROs are the only terms and conditions the applicable third party copyright owners have placed on such PROs.

To the maximum extent permitted by applicable law, PatientsLikeMe, its partners, contributors, agents, employees, directors, or affiliates shall not be liable for any indirect, incidental, special, or consequential damages (even if it has been advised of the possibility of such damages) due to Your use of or reliance on the ORE Platform, Resulting PROs, the PRO Library, Member Responses, Profile Data, or other content or services on the ORE Platform.

8. Digital Millennium Copyright Act.

If You are a copyright owner or an agent thereof and believe that any PRO or other content at ORE Platform infringes upon Your copyright, You may submit a written notification pursuant to the Digital Millennium Copyright Act (“DMCA”) (see 17 U.S.C. 512(c)(3) for further information) by providing our Copyright Agent (listed below) with the following information: (i) an electronic or physical signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed; (ii) a description of the copyrighted work claimed to have been infringed or if multiple copyrighted works are covered by a notification, a representative list of such works at our Site; (iii) a description of the location on the ORE Platform of the allegedly infringing material(s); (iv) Your address, telephone number, and email address; (v) a written statement that You have a good faith belief that use of the material(s) in the manner complained of is not authorized by the copyright owner, its agent, or the law; and (vi) a written statement that the information in the notification is accurate, and under penalty of perjury, that You are authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.

If a PRO that You created, uploaded or inputted onto the ORE Platform has been removed as a result of a notification as described above and You believe that such a PRO was posted lawfully, please contact us about our counter-notification procedure through which You can dispute the allegation and request re-posting of the PRO at issue.

PatientsLikeMe’s designated Copyright Agent for notice of claims of infringement is:

PatientsLikeMe Inc.
Copyright Agent
160 Second Street
Cambridge, MA 02142
telephone: 617-499-4003
email: support@patientslikeme.com

Only notices of alleged copyright infringement and requests about the counter-notification procedures should go to the Copyright Agent; any other feedback, comments, requests for technical support, and other communications should be directed to PatientsLikeMe at support@patientslikeme.com. You acknowledge that if You fail to comply with all of the notice requirements of the DMCA, Your notice may not be valid.

9. Indemnification.

You agree to indemnify and hold harmless PatientsLikeMe, its officers, employees, agents, subsidiaries, affiliates and other partners, from and against any claims, actions or demands, liabilities and settlements including without limitation, reasonable legal and accounting fees, fines, or penalties, resulting from, or alleged to result from, Your violation of this Agreement, including but not limited claims that (a) any PRO You created, deployed, or used infringes or violates the intellectual property or other rights of a third party, (b) You did not obtain the necessary consents or waivers from the subjects of Researcher Submitted Responses necessary or required under applicable laws and regulations to grant PatientsLikeMe the right to use and disclose such Researcher Submitted Responses in accordance with Section 2(e) above, and (c) Your failure to comply with applicable laws and regulations in Your use of any PRO or any responses or data collected by You or which PatientsLikeMe supplies to You.

10. International Users.

PatientsLikeMe makes no claims that PROs in the PRO Library, the Member Responses, or Profile Data is appropriate or may be downloaded outside of the United States. Personal information (“Information”) that is submitted to this Site will be collected, processed, stored, disclosed and disposed of in accordance with applicable U.S. law and our Privacy Policy. If You are a non-U.S. user, You acknowledge and agree that PatientsLikeMe may collect and use Your Information and disclose it to other entities outside Your resident jurisdiction. In addition, such Information may be stored on servers located outside Your resident jurisdiction. U.S. law may not provide the degree of protection for Information that is available in other countries. By providing us with Your Information, You acknowledge that You consent to the transfer of such Information outside Your resident jurisdiction as detailed in our Privacy Policy.

11. Amendments.

PatientsLikeMe reserves the right to modify this Agreement at any time, and without prior notice, by posting amended terms on the ORE Platform. We encourage You to review this Agreement periodically for any updates or changes, which will have an update effective date.

12. Miscellaneous.

This agreement shall be governed by the laws of the Commonwealth of Massachusetts and the applicable federal laws of the United States of America. All disputes arising under, or in any way connected with membership in or use of the Site, shall be litigated exclusively in the state and federal courts residing in the Commonwealth of Massachusetts, and in no other court or jurisdiction. You hereby submit to the jurisdiction of the state and federal courts sitting in the Commonwealth of Massachusetts.

PatientsLikeMe® and the PatientsLikeMe logo are trademarks of PatientsLikeMe. You agree not to display or use these trademarks in any manner without PatientsLikeMe's prior, written permission.

PatientsLikeMe may assign this agreement at any time to a subsidiary or parent company or to a successor to its business as part of a merger or sale of substantially all of its assets. You may not assign or transfer this agreement.

If any provision of this Agreement is held to be unenforceable for any reason, the remaining provisions will be unaffected and remain in full force and effect.

Neither party shall by mere lapse of time, without giving notice or taking other action hereunder, be deemed to have waived any breach by the other party of any of the provisions of this Agreement. Further, the waiver by either party of a particular breach of this Agreement by the other shall not be construed as or constitute a continuing waiver of such breach or of other breaches of the same or other provisions of this Agreement.

The parties acknowledge that this Agreement is the complete and exclusive agreement respecting the subject matter hereto and supersedes and renders null and void any and all agreements and proposals (oral or written), understandings, representations, conditions, and other communications between the parties relating hereto.