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IMEDIDATA TERMS OF USE

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IMEDIDATA TERMS OF USE

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 * Publication: 
   iMedidataiMedidata
   iMedidata
    * iMedidata
    * iMedidata

 * 
 * Last RefreshedNov 30, 2021
 * 
 * 14 min read
 * 


IMEDIDATA TERMS OF USE








Terms of Use – iMedidata

IMPORTANT – READ CAREFULLY:

APPLICABILITY: “Part A” of these Terms of Use is applicable to You, unless You
are either (1) an employee of, or an agent acting on behalf of, a Sponsor or CRO
in the “Part B List” below or (2) a subcontractor or employed by a subcontractor
working directly for a Sponsor or CRO in the “Part B List” below. In such case,
“Part B” applies to You.

For purposes of clarity, if You are an investigator or site staff acting on
behalf of any Sponsor or CRO, Part A below is applicable to You. If you are not
clear as to whether you work for a Sponsor (or CRO) in the “Part B List” at the
bottom of this document, please consult with your company representative or
employer.

PART A

Part A of these TERMS OF USE ("TOU") provide you ("You" or "Your") with notice
of iMedidata’s Terms of Use. Your access to, and use of iMedidata (including any
successor) website ("Website"), and any other Medidata applications, software,
services and other content accessible by you through iMedidata (together with
iMedidata, the “Authorized Applications”), is subject to, and governed by these
TOU. Be sure to carefully read and understand all of the rights and restrictions
delineated in these TOU.

For Your reference, You may print the TOU by using the “Print” option on Your
browser. By accessing the Website, You confirm Your agreement to and acceptance
of these TOU. Medidata reserves the right to update the TOU at any time with
notice to You, and may contact you for that purpose. You may view the current
applicable version of the TOU at any time by clicking on the "Terms of Use" link
at the bottom of a Website page or the link on your login page of the Website.

If You do not wish to follow these TOU, please do not access or use the Website.

1.          Registration.  Use of the Website will require You to register. Only
authorized individuals who have been invited by an authorized person and/or
their company (an “Authority Provider”) may access and use the Website. Your
account is personal to You, is non-transferable, and has been set up for You as
an “Authorized User” and representative of Your company. As such, You shall not
provide other parties access to Your user passwords or access codes. Medidata
shall not be liable for any loss that You incur as a result of someone else
using Your user name or password, either with or without Your knowledge. The
access and use rights granted to You under these TOU terminate immediately if
You fail to comply with the terms and conditions in these TOU, or if You are no
longer retained by Your company or Your invitation to access the Website is
revoked or otherwise restricted or suspended by the Authority Provider. Medidata
also has the right, but not the duty, to terminate or suspend Your access to the
Website or the Authorized Applications, without notice, for any conduct that
Medidata, in its sole reasonable discretion, believes is in violation of any
applicable law or is harmful to the interests of Your company, another user, a
service provider or Medidata. You must at all times keep secure and maintain the
confidentiality of all copies of downloaded materials in Your possession or
control, including the period following termination of Your access rights.

2.         Third Party Access.  Unless You have been granted express authority
in writing by Your company or Medidata to invite others to access the Website,
You shall not provide any third parties access to the Website. If You have been
granted “owner” authority to invite others to access the Website, You shall be
solely responsible for verification of the identity of third parties You invite,
including obtaining and maintaining records of signatures for each such
individual who will access the Website using an electronic signature. Any such
third party access shall be subject to these TOU.

3.         Right Grant and Limitations.  Subject to these TOU, Medidata provides
to You a nonexclusive, personal, revocable and non-transferable right to access
and use the Website, and to access any applications, software, services and
other content available on or through the Website for which You are authorized
by an Authority Provider (together with the Website, the “Authorized
Applications”). You agree not to: (a) decompile, disassemble, or reverse
engineer any software in the Authorized Applications, (b) copy, distribute,
sell, lease, sub-license or transfer any such software or materials contained in
the Authorized Applications or (c) alter, modify or create derivative works
based on any such software or materials. In addition, You agree that: (d) You
shall not misattribute the source of or otherwise falsify the information
transmitted through the Authorized Applications; (e) You shall not place false
or misleading information on the Authorized Applications; (f) You shall not use
or access the Authorized Applications in a manner not expressly permitted by the
Authority Provider or Medidata; (g) You shall not input or upload to the
Authorized Applications any information which contains viruses or other computer
programming routines that are intended to damage, interfere with, intercept or
expropriate any system, the Authorized Applications, or that infringes the
intellectual property rights of another; and (h) You may not use or access the
Authorized Applications in any way that, in Medidata's judgment, adversely
affects the performance or function of the Authorized Applications or interferes
with the ability of authorized parties to access the Authorized Applications.
Except as described in these TOU, no other rights or licenses are granted to You
concerning access or use of the Authorized Applications.

4.      Copyright. Medidata, its suppliers or the original creator of the
material own all copyrights to material on the Authorized Applications and all
other intellectual property rights related to the Authorized Applications.
Medidata grants You permission to copy materials to which You have authorized
access on the Authorized Applications solely in support of Your use of the
Authorized Applications or other Medidata products. You agree that any copies of
material shall retain all copyright and other proprietary notices in the same
form and manner as the original. You may not, without Medidata's permission,
"mirror" any material contained on the Authorized Applications or any other
server. Except as specified above, nothing contained in the TOU shall be
construed as conferring by implication, estoppel or otherwise any license or
right under any trademark, patent, copyright, or any other intellectual property
right of Medidata or any third party.

5.      Trademarks. Medidata, the Medidata logo, and the products and services
described in Authorized Applications, including without limitation, iMedidata
and Medidata Rave are either trademarks, service marks or registered trademarks
of Medidata Solutions, Inc. in the U.S. and/or other countries and may not be
copied, imitated or used, in whole or in part, without the express written
permission of Medidata. All other trademarks, registered trademarks, product
names or logos appearing on the Authorized Applications are the property of
their respective owners or of Medidata Solutions, Inc. in the U.S. and/or other
countries.

6.      Information Provided to Medidata.  To the extent permitted by data
protection laws (see Section 9 of this TOU) and to the extent permitted by
Medidata’s agreement with the Sponsor or CRO, You agree that Medidata and its
related companies may use Your Submissions (which include the professional,
demographic, user, facilities or training profile information maintained by You)
without notice, compensation, or acknowledgement to You, in the course of
Medidata’s business purposes, including but not limited to developing its own
products and services. Other than as set forth in the preceding sentence,
Medidata will not provide Your personal data for any purpose to any third party
except to its own providers (such as subprocessors or subcontractors) subject to
restrictions of confidentiality at least equal to those set forth herein. Except
as set forth in this TOU, Your Submissions shall not be subject to any
obligation on Medidata’s part, including, without limitation, any obligation of
confidentiality, and we shall not be liable for any use or disclosure of any
Submissions. You bear sole responsibility for maintaining the accuracy of the
information You provide to Medidata utilizing the Authorized Applications,
including Your Submissions.

7.      Limitation of Liability. (a) Medidata, their legal representatives as
well as agents and assistants shall only be liable for damages caused by (i)
grossly negligent or intentional acts; or (ii) culpable breaches of a material
contractual obligation – i.e. an obligation the performance of which is required
for reaching the purpose of this agreement or, respectively, the breach of which
endangers reaching the purpose of this agreement and the compliance with which
customer therefore usually may rely on. Any further liability for damages –
irrespective of its legal ground – shall be excluded. (b) In case Medidata is
liable according to clause (a)(ii) above for a culpable breach of a material
contractual obligation but without acting with gross negligence or
intentionally, its liability shall be limited to the damage of customer that was
reasonably foreseeable for Medidata according to their knowledge when entering
into these TOU. (c) Medidata shall not be liable for any indirect damages,
consequential damages and loss of profit. (d) The exclusions and limitations of
liability as set out above shall not apply to (i) a liability for fraudulent
concealment of a defect, (ii) a liability for grossly negligent or intentional
acts, (iii) a liability for damages suffered due to fatal and bodily injuries or
health impairments which were culpably caused, (iv) a liability for damages due
to legal costs in case of default, and (v) a liability due to statutory product
liability which cannot be excluded.

8.      Governing Law.  If You are an employee of, an agent acting on behalf of,
a subcontractor or employed by a subcontractor working directly for, a Sponsor
or CRO having its primary place of business in the European Economic Area or in
Switzerland, this Agreement shall be governed by and construed in accordance
with the laws of Germany. The United Nations Convention on Contracts for the
International Sale of Goods shall not apply. The parties exclusively submit to
the jurisdiction of the courts of Frankfurt, Germany.

If You are an employee of, an agent acting on behalf of, a subcontractor or
employed by a subcontractor working directly for, a Sponsor or CRO that does not
have its primary place of business in the European Economic Area or in
Switzerland, then the following provisions of this paragraph shall apply. The
validity, construction and performance of this Agreement will be governed by the
substantive laws of the State of New York, without giving effect to any
provisions that would result in this Agreement being governed by the law of any
jurisdiction other than that of the State of New York, USA. The parties
specifically disclaim the UN Convention on Contracts for the International Sale
of Goods. You consent to the exclusive jurisdiction of, and venue in, any
federal or state court located in the Borough of Manhattan, New York City for
the purposes of adjudicating any matter arising from or in connection with these
TOU. YOU EXPRESSLY WAIVE ANY OBJECTION THAT YOU MAY HAVE NOW OR HEREAFTER TO THE
LAYING OF THE VENUE OR TO THE JURISDICTION OF ANY SUCH PROCEEDING.  YOU AGREE
THAT ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR RELATED TO YOUR USE OF THE
WEBSITE, AND/OR CONTENT MUST BE FILED WITHIN ONE (1) YEAR AFTER SUCH CLAIM OR
CAUSE OF ACTION AROSE.

9.      Privacy Policy.  Medidata believes strongly in protecting user privacy
and providing You notice of Medidata’s collection and use of data, including
Personal Data (as defined under Directive 95/46/EC, and any successor laws
governing data protection). Medidata uses Your personal data to provide You
access to the Authorized Applications (including the Website) where You
registered for, access and make use of, the Authorized Applications. As part of
Your access and use, Medidata may share Your personal data with Your the
Authority Provider. Beyond the purpose of providing You access to the Website,
Medidata acts as a processor (as defined under Directive 95/46/EC or, as of May
25, 2018, the General Data Protection Regulation (GDPR) (EU) 2016/679) for and
on behalf of your company and/or the Authority Provider. As processor, Medidata
will otherwise use Your personal data only according to instructions from your
company and/or the Authority Provider. As such, Medidata may make use of your
personal data to: (1) provide you with notice of updates to this TOU, (2)
improve the Website or Authorized Applications, (3) develop products related to
the Website or Authorized Applications, (4) prevent or address service issues or
provide support for technical problems, (5) respond to our customer’s
instructions, or (6) as may be required by law.

Exercise of Your Rights under the GDPR. If you are based in the European
Economic Area, the GDPR provides you with data subject rights, namely: the right
to be informed, the right of rectification, the right of erasure, the right to
restrict processing, the right of data portability, the right to object, and the
right of access. To the extent that the Website does not provide you with the
ability to exercise any of your rights as a data subject under the GDPR, please
contact our Data Protection Officer at dataprivacy@mdsol.com. We will
communicate your request to exercise your rights under the GDPR to the Authority
Provider and promptly act on the Authority Provider’s instructions regarding
your request.

Privacy Shield Compliance.  Medidata complies with the EU-US Privacy Shield
Framework and the Swiss-US Privacy Shield Framework as set forth by the U.S.
Department of Commerce regarding the collection, use, and retention of personal
information transferred from the European Union to the United States. Medidata
has certified to the Department of Commerce that it adheres to the Privacy
Shield Principles. If there is any conflict between the Privacy terms in this
Terms of Use and the Privacy Shield Principles, the Privacy Shield Principles
shall govern. To learn more about the Privacy Shield program, and to view our
certification, please visit https://www.privacyshield.gov/ . Please view our
Privacy Shield Notice (which is part of this TOU) at
https://www.mdsol.com/en/legal/privacy-shield to learn more about Medidata's
obligations and your rights under the Privacy Shield.

Privacy Shield Dispute Resolution. In compliance with the Privacy Shield
Principles, Medidata commits to resolve complaints about our collection or use
of your personal information. Individuals in the European Union or Switzerland
with inquiries or complaints regarding our Privacy Shield policy should first
contact Medidata at dataprivacy@mdsol.com.

As set forth in our Privacy Shield Notice, Medidata has selected a third party
to serve as its independent recourse mechanism (IRM) for dispute resolution
arising from certain transfers or processing of Personal Information (non­-HR
data) under Privacy Shield. Medidata has further committed to refer unresolved
Privacy Shield complaints to the Council of Better Business Bureaus (CBBB), an
alternative dispute resolution provider located in the United States. If you do
not receive timely acknowledgment of your complaint from us, or if we have not
addressed your complaint to your satisfaction, please contact or visit the CBBB
at http://www.bbb.org/EU-privacy-shield/bbb-eu-safe-harbor-dispute-resolution/
for more information or to file a complaint. The services of CBBB are provided
at no cost to you.

10.    Compliance with Law and Good Clinical Practices.  You agree to use the
Website and its content in strict compliance with all applicable laws, rulings
and regulations and in a fashion that does not, in the sole judgment of
Medidata, negatively reflect on the goodwill or reputation of Medidata. You
further agree not to transmit any material that encourages conduct that could
constitute a criminal offense, give rise to civil liability or otherwise violate
any applicable local, state, national, or international law or regulation. While
Medidata has designed its software and services to adhere to International
Conference on Harmonisation (ICH) Good Clinical Practices (GCP) and similar
international regulations and guidelines (such as those issued by EMA and FDA)
applicable to electronic clinical research data, each Medidata customer and
their Authorized Users are responsible for ensuring that their use of the
software and services comply with all such regulations and practices.

11.       Links. ANY LINKS ON THE WEBSITE THAT ALLOW YOU TO ACCESS A THIRD PARTY
SITE ARE NOT UNDER THE CONTROL OF MEDIDATA AND MEDIDATA IS NOT RESPONSIBLE FOR
THE CONTENTS OF ANY THIRD-PARTY LINKED SITE, ANY LINK CONTAINED IN SUCH LINKED
SITE, OR ANY CHANGES OR UPDATES TO SUCH SITES.  MEDIDATA IS PROVIDING THESE
LINKS TO YOU ONLY AS A CONVENIENCE, AND THE INCLUSION OF ANY LINK TO A
THIRD-PARTY SITE DOES NOT IMPLY ENDORSEMENT BY MEDIDATA OF THE SITE. CERTAIN
MEDIDATA WEBSITES, INCLUDING OTHER PASSWORD PROTECTED SITES, CONTAIN TERMS OF
USE IN ADDITION TO, OR DIFFERENT FROM THESE TOU. THE TERMS OF USE POSTED ON SUCH
WEBSITES SHALL APPLY TO THEIR USE.

12.    Disclaimers.  Material, including software, on the Authorized
Applications as well as the Authorized Applications is provided "as is", and
Medidata may change the information on the Authorized Applications. As You do
not have to remunerate Your access to the Website, Medidata does not provide any
warranty, unless acting willfully or with gross negligence. Medidata
specifically disclaims any warranties of merchantability or fitness for a
particular purpose with respect to the Authorized Applications or any content or
material on the Authorized Applications. Unless explicitly confirmed in text
form such as may be set forth in Medidata’s service level agreement with its
customers (e.g., a sponsor or CRO), Medidata makes no warranty that (i) the
Authorized Applications will meet Your requirements, (ii) access to the
Authorized Applications will be uninterrupted, timely, secure, or error-free,
(iii) the results that may be obtained from the use of the Authorized
Applications will be accurate or reliable, or (iv) any errors in the software
will be corrected.




CONTACT

If You are an employee of, an agent acting on behalf of, a subcontractor or
employed by a subcontractor working directly for, a Sponsor or CRO a Sponsor or
CRO having its primary place of business in the European Economic Area or in
Switzerland, and You have any questions or comments regarding these TOU, please
contact Medidata customer service at helpdesk-eu@mdsol.com. For any questions
about Medidata’s data privacy practices, or to request access to or correction
of Your personal data, please contact us at dataprivacy@mdsol.com.

Individuals located in the EU may also submit their inquiries to:




Medidata Solutions International Limited

12 Hammersmith Grove, 9th Floor

Hammersmith, London, W6 7AP UK







If You are an employee of, an agent acting on behalf of, a subcontractor or
employed by a subcontractor working directly for, a Sponsor or CRO a Sponsor or
CRO that does not have its primary place of business in the European Economic
Area or in Switzerland and You have any questions or comments regarding these
TOU, please contact Medidata customer service at helpdesk@mdsol.com. For any
questions about Medidata’s data privacy practices, or to request access to or
correction of Your personal data, please contact us at dataprivacy@mdsol.com.




This constitutes the entire Terms of Use with respect to the Authorized
Applications and their use and, except with respect to any Medidata product or
service containing additional or different terms of use, supersedes all prior
agreements, proposals, communications between the parties and understandings,
whether written or oral.







PART B

Your access to, and use of, iMedidata or any other Medidata Solutions
International Limited (“Medidata”) (for full contact details, see Section
“CONTACT” at the end of this document) applications, software, services and
other content accessible by you through iMedidata (together with iMedidata, the
“Authorized Applications”), is provided to you by your employer (or, if you are
a subcontractor, by the Sponsor or CRO with whom you or your employer is
subcontracting) (“Authority Provider”). You must be invited by your employer in
order to be authorized to use the Authorized Applications.

You may only access or use the Authorized Applications subject to the terms,
conditions, restrictions, obligations or requirements regarding the use of
third-party software applications (and/or the use of the Authorized
Applications) provided by your Employer (or, if you are a subcontractor, by your
employer or by the Sponsor or CRO with whom you or your employer are
subcontracted).

Other than as may be expressly provided to you by your employer (or, if you are
a subcontractor, by the Sponsor or CRO with whom you or your employer are
subcontracting), your access to, or use of, the Authorized Applications does not
create any relationship to, or create any rights with regard to, Medidata.

Medidata uses your personal data to provide you access to the Authorized
Applications (including the iMedidata Website) where you registered for, access
and make use of, the Authorized Applications. Your personal information includes
name, email address, authentication information, address information, contact
information, answer to pre-defined security question and information about
eLearning. As part of your access and use, Medidata shares your personal data
with the Authority Provider. Beyond the purpose of providing you access to the
iMedidata Website, Medidata only acts as a processor (as defined under Directive
95/46/EC) for and on behalf of the Authority Provider. As processor, Medidata
will otherwise use your personal data only according to instructions from the
Authority Provider.




CONTACT

If You have any questions or comments regarding these TOU, Medidata’s data
privacy practices, or to request access to or correction of Your personal data,
please contact Medidata customer service at helpdesk-eu@mdsol.com . Individuals
located in the EU may also submit their inquiries to:




Medidata Solutions International Limited

12 Hammersmith Grove, 9th Floor

Hammersmith, London, W6 7AP UK




Part B List




 * Boehringer Ingelheim Group




Last Updated May 22, 2018
















  




 

 







 * (c) 1999 - 2024 Medidata Solutions, Inc., a Dassault Systemes company.
 * Proprietary and Confidential. External distribution prohibited without prior
   written authorization. Trademarks are the property of their respective
   owners. All Rights Reserved.
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