These Terms of Use cover your access to and use of this website. Upon notice to you, which notice may be provided by posting such new changes on the website and, if you are a registered user, by email sent to the email address set forth in your application to be a registered user, Project Data Sphere(Project Data Sphere) may change these Terms of Use. You must adhere to and abide by these Terms of Use and other guidelines provided to you by Project Data Sphere from time to time. Project Data Sphere reserves the right to terminate or limit use of this website without notice in the event of any unauthorized access to or use of the website.

Scope of Use

Project Data Sphere invites you to view, use and download a single copy of the publicly accessible portions of this website for your informational, non-commercial use. You acknowledge that certain portions of this website are available only to registered users, and the website includes a user registration application. No part of any content or software that is intended for access only by registered users may be accessed, used, copied, downloaded or stored in a retrieval system by anyone who is not a registered user.

You may not:

• use the website to misuse or abuse any third-party property (including, without limitation, software, equipment, networks, and network devices); or
• make any unauthorized use of or interfere with any property of SAS Institute, Inc. ("SAS"), which hosts the website for Project Data Sphere, or of any customer of SAS; or
• engage in any activity that is in violation of the law or aids or assists any criminal activity in connection with your access or use of the website; or
• impair or disrupt any connections to the website; or
• upload any software or application(s) to the website.

You may not use the website:

• to send unsolicited marketing material or communications in any form (commonly referred to as "SPAM"); or
• to engage in any activities or actions that infringe or misappropriate the intellectual property rights of others, including, but not limited to, using third party copyrighted materials without appropriate permission, using third party trademarks without appropriate permission or attribution, or using or distributing third party information protected as trade secret information in violation of a duty of confidentiality; or
• to engage in any activities or actions that would violate the personal privacy rights of others; or
• to send or transmit harassing, abusive, libelous, or obscene materials or assist in any similar related activities; or
• to intentionally omit, delete, forge, or misrepresent transmission information, including headers, return mailing, and Internet protocol addresses; or
• to engage in any activities or actions intended to misuse or abuse other users' passwords or other confidential information; or
• for any illegal purpose, in violation of any applicable laws or regulations, or in violation of the rules of any other service provider engaged by or for your benefit; or
• to assist or permit any person to engage in any of the activities described above.

You understand that Project Data Sphere may discontinue or change the website at any time, without notice. You also understand that Project Data Sphere may discontinue or restrict your use of this website for any reason without notice.

No Warranties

ALL CONTENT ON THIS WEBSITE IS PROVIDED TO YOU ON AN "AS IS" "AS AVAILABLE" BASIS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. PROJECT DATA SPHERE MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. USE OF THIS WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK.

PROJECT DATA SPHERE MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THIS WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU MAY OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES.

Limitation of Liability

PROJECT DATA SPHERE, ON BEHALF OF ITSELF, EACH OF ITS LICENSORS, ITS HOSTING SERVICE PROVIDER AND EACH DATA PROVIDER DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THIS WEBSITE, EVEN IF ANY OF THE FOREGOING HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THE WEBSITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THE WEBSITE, OR RELATED INFORMATION OR COMPUTER PROGRAMS.

Trademarks

PROJECT DATA SPHERE and the accompanying logo are service marks ofProject Data Sphere. Unauthorized use of any Project Data Sphereservice mark or logo may be a violation of federal and state trademark laws.

Copyright

This website is protected by U.S. copyright laws and international treaties. Except for your informational, personal, non-commercial use as authorized above, you may not modify, reproduce or distribute any content that is accessible on this website without written authorization by Project Data Sphere.

Compliance with the Digital Millennium Copyright Act of 1998.

As a courtesy, Project Data Sphere is providing the following information regarding its understanding of the Digital Millennium Copyright Act of 1998 ("DMCA") concerning notice of claimed online copyright infringement. Project Data Sphere is not providing legal advice. Any persons wishing to assert or oppose a claim under the DMCA should consult their own legal adviser concerning these matters.

The DMCA provides recourse for owners of copyrighted material who believe that their rights under U.S. copyright laws have been infringed online. Under the DMCA, copyright owners may contact the authorized agent of an Internet service provider to report alleged infringements based on unauthorized use of their protected works appearing on web pages hosted by the service provider. Upon receipt of properly filed complaints satisfying the requirements of the DMCA, Project Data Sphere will remove or block access to the allegedly infringing material posted by third party users of the Project Data Sphere website. If a person who provided such material to Project Data Sphere believes in good faith that a notice of copyright infringement has been wrongly filed, that person may submit a counter-notice to assert a private dispute with the claimed copyright owner. Project Data Sphere will not be a party to such disputes over alleged copyright infringement.

Notification of Claimed Copyright Infringement.

If you believe in good faith that information posted by a user on this website violates your rights under U.S. copyright law, you must give Project Data Sphere written notification of your claim in accordance with the requirements of the DMCA, which are summarized below. Written notification of your claim must be submitted to the following designated agent to receive notification of claimed infringement:

Project Data Sphere

1204 Village Market Pl. Suite 288

Morrisville, NC 27560

Attn: Nicole Williford Hayes

E-mail: nicole.hayes@projectdatasphere.org

To be effective, the notification must include the following:

• A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.
• Identification of the copyrighted work claimed to have been infringed, or if multiple copyrighted works at a single online website, are covered by a single notification, a representative list of works at that site.
• Identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and information reasonably sufficient to permit Project Data Sphere to locate the material.
• Information reasonably sufficient to permit Project Data Sphere to contact the complaining party, such as an address, telephone number, and if available, an e-mail address at which the complaining party may be contacted.
• A statement that the complaining party has a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law.
• A statement that the information in the notification is accurate, and under penalty of perjury, that the complaining party is authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.

Upon receipt of the written notification containing the information as outlined in clauses (1) through (6) above:

• Project Data Sphere shall remove or disable access to the material that is alleged to be infringing and shall forward the written notification to the person or entity who provided the material at issue to Project Data Sphere; and
• Project Data Sphere shall take reasonable steps to promptly notify the alleged infringer that it has removed or disabled access to the material.

You should be aware that U.S. copyright law provides substantial penalties for false claims of copyright infringement. According to the DMCA, claimants who make misrepresentations concerning copyright infringement may be liable for damages incurred as a result of the removal or blocking of the material, court costs, and attorney's fees.

Responding to a Claim of Copyright Infringement

A person who receives a notification of alleged copyright infringement, and believes that the claim is erroneous, may submit a counter notification to Project Data Sphere's designated agent referenced above within thirty (30) days of the date the material was removed from the Project Data Sphere website.

To be effective, a counter notification must be a written communication that includes substantially the following:

• A physical or electronic signature of the person submitting the counter notification.
• Identification of the material that has been removed or to which access has been disabled and the location at which the material appeared before it was removed or access to it was disabled.
• A statement under penalty of perjury that the person submitting the counter notification has a good faith belief that the material was removed or disabled as a result of mistake or misidentification of the material to be removed or disabled.
• The person's name, address, and telephone number, and a statement that he or she consents to the jurisdiction of the federal district court for the judicial district in which the address is located, or if the person's address is outside of the United States, for any judicial district in which Project Data Sphere may be found, and that the person will accept service of process from the complaining party or an agent of such person.

Upon receipt of a counter notification containing the information as outlined in clauses (1) through (4) above:

• Project Data Sphere shall promptly provide the complaining party with a copy of the counter notification; and
• Project Data Sphere shall inform the complaining party that it will replace the removed material or cease disabling access to it within ten (10) business days.

Project Data Sphere shall replace the removed material or cease disabling access to the material within ten (10) to fourteen (14) business days following receipt of the counter notification, provided Project Data Sphere's designated agent has not received notice from the complaining party that an action has been filed seeking a court order to restrain the alleged infringer from engaging in infringing activity on the Project Data Sphere website.

Links

This website may contain links to websites operated by other parties as a convenience to users. The linked sites are not under the control of Project Data Sphere, and Project Data Sphere is not responsible for the content available on any other website that is linked to the website. Such links do not imply Project Data Sphere's endorsement of material on any other site, and access to any other Internet sites linked to this website is at your own risk. Project Data Sphere disclaims all liability with regard to your access to such linked websites.

Unless otherwise set forth in a written agreement between you and Project Data Sphere, you must adhere to Project Data Sphere's linking policy as follows: (i) any link to this website must be a text only link clearly marked "Project Data Sphere," (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Project Data Sphere's name and service marks, (iii) the link must "point" to the URL www.projectdatasphere.org or data.projectdatasphere.org and not to other pages within this Website, (iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, affiliated with, or associated with Project Data Sphere, (v) when selected by a user, the link must display this website on full-screen and not within a "frame" on the linking website, and (vi) Project Data Sphere reserves the right to revoke its consent to the link at any time and in its sole discretion.

Use of Information

The information provided on this website is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to law or regulation or which would subject Project Data Sphere or its affiliates to any registration requirement within such jurisdiction or country.

Location

This website is operated for Project Data Sphere from its hosting service provider's facility the state of North Carolina USA, and these Terms of Use shall be governed and construed in accordance with the laws of the state of North Carolina USA. Project Data Sphere makes no representation that the information in the website is appropriate or available for use in any other jurisdictions, and access to this website from any jurisdiction to which the export of United States data is prohibited or any jurisdiction where the content of the website may be illegal is prohibited. Those who choose to access this website from other jurisdictions do so on their own initiative and are responsible for compliance with applicable laws.

Violations and Additional Policies

Project Data Sphere reserves the right to seek all remedies available at law and in equity for violations of these Terms of Use, including the right to block access from a particular Internet address to the website.

What information do we collect?

Information You Provide - We collect information that you voluntarily provide when you use the Site, including when you:

• contact us with a question, comment or request;
• apply for authorization to access clinical trial data on the website;
• visit and access clinical trial data as an authorized user;
• post a profile or other information on a personal or group page or other interactive feature("Community Tools");
• participate in chat rooms;
• utilize messaging capabilities offered through the Site like email; or
• participate in sweepstakes, contests or promotions with us or promotions partners.

The information that you provide us can include, but is not limited to:

• your name;
• contact information such as physical address, email address and phone number;
• employer name, address and website url;
• workplace department and position, education and other professional credentials, including professional licenses;
• username (including a display name used in Community Tools), password, and other registration information; and
• your photograph or other audiovisual images.

Information Automatically Collected From You - We and our service providers may automatically collect certain technical information from your computer when you use the Site, such as your Internet Protocol ("IP") address, your browser type, your operating system, the pages you view on the Site, the pages you view immediately before and after you access the Site, and the search terms you enter on the Site. This information allows us to recognize you and personalize your experience if you return to the Site using the same computer, and to improve the Site and the services we provide. We and our service providers may collect this information using "cookies," which are small text files that the Site saves on your computer using your web browser and accesses when you return. If you do not want the Site to collect information through the use of cookies, you can set your web browser to reject cookies from the Site. Each browser is different, so you should check your browser's "Help" menu to learn how to change your cookie preferences. If you reject or block cookies from the Site, however, the Site may not function as intended.

How do we use this information?

We may use the information we collect for a number of purposes, including, but not limited to:

• providing you information if you have submitted a comment or question;
• communicating to you information about the Site, our service or your account;
• evaluating and processing applications for authorization to access clinical data;
• facilitating access to clinical trial data by authorized users;
• customizing your experience on the Site, such as by recognizing you as an authorized user for more efficient account access;
• allowing us and our service providers to improve the Site and the services we provide, such as by better tailoring our content to our users' needs and preferences;
• enabling participation in various Community Tools;
• generating and analyzing statistics about your use of the Site; and
• detecting, preventing, analyzing and responding to fraud, intellectual property infringement, violations of obligations and restrictions you have agreed to in our Online Services User Agreement, violations of the website Terms of Use, violations of law, other misuse of the Site.

We also may combine or aggregate any of the information we collect through the Site with information we collect elsewhere including from third parties for any of these purposes.

Under what circumstances do we disclose this information?

We may disclose the information we collect from you through the Site:

• to affiliates and service providers who we work closely with, or who work on our behalf, and have agreed to use the information solely in furtherance of our operations, including, but not limited to, our Site hosting service provider and its contractors and subcontractors;
• to third party clinical trial data providers to enable such providers to enforce contractual obligations and restrictions you have agreed to in our Online Services User Agreement;
• pursuant to a subpoena, court order or other lawful process, including to law enforcement;
• when we believe in good faith that disclosure is necessary (a) to protect our rights, the rights of others, the integrity of the Site, or your safety or the safety of others, or (b) to detect, prevent, or respond to fraud, intellectual property infringement, violations of the website Terms of Use, violations of law, or other misuse of the Site; and
• to third parties to the extent reasonably necessary to proceed with the negotiation or completion of a merger, acquisition, or sale of all or a portion of our assets.

In addition, we may share aggregate reports on user demographics and traffic patterns to better understand Site usage. We may also share de-identified information with third parties for various purposes, including research, studies and marketing.

What About Community Tools?

You may be able to contribute to interactive Community Tools on the Site such as message boards, chat rooms, personal web pages or profiles, forums, groups and bulletin boards. We may display your contributions to Community Tools to the public or to others within a group in which you may participate. We also may store your contributions to Community Tools. Note that if you include photos or other information that identifies you in your profile or in contributions to Community Tools, it can be used and viewed by others. Therefore, you understand that you have no expectation of privacy or confidentiality in the content you submit for profiles or to Community Tools, whether or not it identifies you. We are not responsible for the information you choose to include or view in any Community Tools. In addition, by participating in Community Tools, you may receive communications, such as emails or other messages, from other users.

Where is this information stored?

The Site is a United States-based website. Information collected through the Site will be processed in and subject to the laws of the United States, which may not provide the same level of protection for your personal information as your home country provides, and may be available to the United States government or its agencies under a lawful order made in the United States. However, our Site hosting service provider is certified under the U.S.-E.U. and the U.S.-Swiss safe harbor framework. In addition, we may transfer your information outside of the United States to our afiliates, data providers and service providers who may be located in other countries. By using and submitting information to the Site, you consent to such transfer to, and processing in, the United States and other countries.

How is your information secured?

We maintain reasonable administrative, technical, and physical safeguards designed to safeguard the information collected by the Site. However, no information system can be 100% secure, so we cannot guarantee the absolute security of your information. Moreover, we are not responsible for the security of information you transmit to the Site over networks that we do not control, including the Internet and wireless networks. We maintain the information we collect consistent with legitimate business purposes.

What if there are changes to this Privacy Policy?

We reserve the right to update this Privacy Policy from time to time by posting a new Privacy Policy on this page. You are advised to consult this Privacy Policy regularly for any changes, and your continued use of the Site after such changes have been made constitutes acceptance of those changes. If we make any revisions that materially change the ways in which we use or share the information previously collected from you through the Site, we will give you the opportunity to consent to such changes before applying them to that information.

Contact us

If you have any questions about this Privacy Policy or our use of your information collected through the Site, please contact us at info@projectdatasphere.org.

Effective July 2013

Updated September 2014