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End User Tool Terms and Conditions

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PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE USING THE END USER TOOL ACCOMPANYING OR REFERENCING THESE TERMS SO YOU FULLY UNDERSTAND YOUR RIGHTS AND RESPONSIBILITIES, AND THE LIMITATIONS APPLICABLE TO YOUR USE.

The following terms and conditions (“Terms of Use”) apply to your access to and use of any End User Tool, as defined below, provided or made available by PPD Development, L.P. or its affiliates (collectively, “PPD”), a part of Thermo Fisher Scientific, Inc. By using any such End User Tool, you agree to the Terms of Use when this option is made available to you, you agree on behalf of yourself, and the company with whom you are employed, (i) to be bound by these Terms of Use, and (ii) that any information you provide about yourself will be handled in accordance with Thermo Fisher Scientific’s Privacy Policy found at https://www.thermofisher.com/us/en/home/global/privacy-policy.html.

End User Tools Terms of Use

  1. The products, solutions, or outputs built with productivity software by end user personnel of PPD (each, an “End User Tool”) are tools which may be provided to clients of PPD. Use of such End User Tool is offered to employees, representatives, and authorized agents of PPD’s clients, and vendors and study investigator sites involved in PPD client sponsored projects (each, a “User”) and is intended to assist such Users in accessing, viewing, and, in some cases, exporting and exchanging data. The End User Tool and the data, records, and other information contained therein have not been validated and are not intended to comply with regulatory requirements or specifications including, without limitation, 21 CFR Part 11. The End User Tool may provide data, records, and other information regarding various aspects of projects, including, but not limited to, operational and clinical trial data, project status summaries and other project management information. However, the End User Tool does not monitor product safety or efficacy. Further, the End User Tool should not be used in, nor is it intended to be used in, any regulatory audit or inspection. The End User Tool is not a substitute for the exercise of professional judgment in fulfilling any monitoring and/or reporting obligations.
  2. In many cases, data, records, and other information may be delivered to the End User Tool in near-real time from various primary sources. Further verification, modification or “cleaning” is regularly performed within these sources as additional information becomes available. Any such changes are reflected within the End User Tool via regularly scheduled updates from an applicable source. User acknowledges that multiple sources or providers (other than PPD) may provide data, records, or other information that will be visible through the End User Tool. The End User Tool receives updates from source systems at different rates and times based on business relevance and system constraints. Thus, while PPD attempts to provide accurate and timely data, records, and other information via the End User Tool, except with respect to those records specifically designated by PPD as being a final and complete record (each a “Complete Record”), the data, records, and other information visible through the End User Tool is provided “AS IS” and PPD makes no representation or warranty that the data, records, or other information visible through the End User Tool are accurate or suitable for any particular purpose. Under no circumstances should the data, records, or other information made available through the End User Tool, or visualizations thereof, be: (i) used as a rationale for decisions regarding drug development, investments, or other business matters; (ii) subjected to statistical analysis or in any way serve as a substitute for data, records, or other information transmitted in a final, clean dataset; (iii) submitted to any regulatory agency, data safety monitoring board, or similar entity; (iv) incorporated into any clinical study report or regulatory filing; (v) used for regulatory audit or inspection purposes; or (vi) disclosed to any third parties. By accessing the End User Tool, you acknowledge and agree that the data, records, and other information made available therein shall not be used for any purpose other than your internal reference only.
  3. User acknowledges that the End User Tool is provided “AS IS”. PPD expressly disclaims any warranties of any kind with respect to the End User Tool, whether express or implied, and specifically disclaims any implied warranty of merchantability or fitness for a particular purpose, and any warranty of non-infringement. Under no circumstances is PPD liable for the use of the End User Tool by a User or the use or disclosure of any data, records, or other information from the End User Tool by a User.
  4. Under no circumstance may any person who ceases to be an employee, representative or authorized agent of a PPD client, or a vendor or investigator site involved in a PPD client sponsored project access the End User Tool. Users may not allow any other person to have access to the End User Tool without the prior written consent of PPD. All passwords, when and if required, used to access this End User Tool must be kept confidential by the named, approved, intended user and are not to be shared or used by any third party. If User believes that a password has become known to someone else, User must i) immediately change their password, and ii) provide details around the timing of the incident and the last valid log-in time and date to the Clinical Systems Support team via http://support.ppdi.com. PPD has the right to disable any User’s username and/or password at any time and for any reason.
  5. User expressly acknowledges that the End User Tool and its features and functionality are owned by PPD. User may not reproduce, modify, create derivative works of, disclose or publicly display the End User Tool or its features and functionality without the express written consent of PPD.
  6. All data, records, and other information made available within the End User Tool is and shall remain the confidential and proprietary property of the PPD client sponsoring the project (each a “Sponsor”) or PPD as the case may be. User shall not use or disclose to any third party any data, records, or other information made available within the End User Tool, without the prior written consent of the Sponsor or PPD as the case may be. User agrees to take at least as much care in keeping the information confidential as User would in connection with User’s own, or User’s employer’s confidential information. User will process all data, records, or other information made available within the End User Tool in compliance with all applicable data privacy laws (if any).
  7. User shall not use or access the End User Tool or any data, records, or other information made available within the End User Tool for any purpose other than with respect to User’s obligations on the project with which User is authorized by Sponsor or PPD. User agrees not to (i) use the End User Tool in any way that violates any applicable federal, state, local or international law or regulation; (ii) impersonate another user or any other person; (iii) use the End User Tool in any manner that could disable, overburden, damage, or impair the End User Tool or interfere with another user’s use of the End User Tool; and (iv) upload any viruses, Trojan horses, worms, time bombs, cancelbots or other computer programming routines that are intended to damage, interfere with, intercept or expropriate the End User Tool.
  8. Each User acknowledges that PPD does not have control over User’s use of the End User Tool. User shall comply with all reasonable instructions and training materials (as applicable) regarding the use of the End User Tool. PPD tries to ensure the End User Tool is available 24 hours per day, 7 days per week other than for brief periods of maintenance and updates; however, PPD does not warrant or represent that the operation of the End User Tool will be uninterrupted or error free. For the avoidance of doubt, PPD may suspend all or part of the End User Tool without liability or prior notice: (i) in order to maintain and/or repair the End User Tool; (ii) as PPD determines may be required by law or regulation; (iii) as may be necessary to protect the End User Tool; or (iv) if the data, records, or other information made available within the End User Tool are or become no longer available to PPD.
  9. PPD IS NOT RESPONSIBLE OR LIABLE TO USER OR TO ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR ANY OTHER DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS, LOSS OF DATA OR LOST PROFITS), UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY ARISING OUT OF OR RELATING IN ANY WAY TO THE END USER TOOL AND/OR THE INFORMATION MADE AVAILABLE WITHIN THE END USER TOOL. WITHOUT LIMITING THE FOREGOING, PPD SHALL HAVE NO LIABILITY OR RESPONSIBILITY WHATSOEVER FOR (I) ANY FAILURE OF ANOTHER USER OF THE END USER TOOL TO CONFORM TO THESE TERMS OF USE, (II) ANY INTERRUPTION OR UNAVAILABILITY OF OR INABILITY TO USE THE END USER TOOL OR CESSATION OF TRANSMISSION TO OR FROM THE END USER TOOL, (III) ANY BUGS, VIRUSES, WORMS, TROJAN HORSES, TIME BOMBS OR OTHER ITEMS OF A DESTRUCTIVE NATURE WHICH MAY BE TRANSMITTED TO OR THROUGH THE END USER TOOL BY ANY THIRD PARTY, AND/OR (IV) ANY ERRORS, INACCURACIES OR OMISSIONS IN ANY INFORMATION MADE AVAILABLE WITHIN THE END USER TOOL THAT IS NOT A COMPLETE RECORD, OR FOR ANY LOSS OR DAMAGE OF ANY KIND INCURRED AS A RESULT OF THE USE OF ANY DATA, RECORDS, OR OTHER INFORMATION MADE AVAILABLE WITHIN THE END USER TOOL. THE USER’S SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO THE END USER TOOL IS TO STOP USING THE END USER TOOL. THE MAXIMUM LIABILITY OF PPD FOR ALL DAMAGES, LOSSES SUFFERED AND CAUSES OF ACTION, WHETHER IN CONTRACT, TORT (INCLUDING, WITHOUT LIMITATION, NEGLIGENCE) OR OTHERWISE, SHALL BE THE TOTAL AMOUNT PAID BY USER, IF ANY, TO ACCESS THE END USER TOOL, OR IN THE CASE OF SPONSOR, THE TOTAL AMOUNT PAID BY SPONSOR TO PPD FOR SERVICES RELATING TO THE PROJECT.

    User may have or may in the future have claims against PPD which User does not know or suspect to exist in User’s favor when User agreed to these Terms of Use and which if known, might materially affect User’s consent to these Terms of Use. User expressly waives all rights User may have under Section 1542 of the California Civil Code, which states:

    A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN ITS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.
  10. No agency, partnership, joint venture, employee-employer or franchiser-franchisee relationship is intended or created by these Terms of Use.
  11. PPD may change these Terms of Use from time to time by posting a modified copy on this site. These changes will be effective and binding as of posting of the modified copy, unless a different effective date is specified. User’s continued use of the End User Tool following the posting of revised Terms of Use means that User accepts and agree to the changes.
  12. All matters relating to these Terms of Use and any dispute or claim related thereto shall be governed by and construed in accordance with the laws of the State of New York without giving effect to any choice or conflict of law provision or rule. With respect to any provision of these Terms of Use that is held to be invalid, illegal or unenforceable for any reason, such provision shall be eliminated or limited to the minimum extent such that the remaining provisions of the Terms of Use will continue in full force and effect.