IMPORTANT – READ CAREFULLY:
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.
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.
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 firstname.lastname@example.org. 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 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 email@example.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.
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.
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 firstname.lastname@example.org. For any questions about Medidata’s data privacy practices, or to request access to or correction of Your personal data, please contact us at email@example.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 firstname.lastname@example.org. For any questions about Medidata’s data privacy practices, or to request access to or correction of Your personal data, please contact us at email@example.com.
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.
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 firstname.lastname@example.org . 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