License Agreement

Meditrial Europe Ltd., (“MediTrial”) with an address of Bahnhofstrasse 23, CH-6300 Zug, Switzerland hosts and offers the proprietary clinical software for capturing clinical trial data and images (the “Catchtrial Software”), subject to the terms and conditions set forth in this Agreement. MediTrial and Customer may be referred to herein individually as a “party” and collectively as the “parties.”
If Customer does not agree to these Terms and Conditions or any part thereof, the only remedy is not to use the Catchtrial Software. Violation of any of the terms below will result in the automatic termination of Customer right to use the Catchtrial Software and any account that Customer may have created as part of the Service.

Catchtrial Terms and Conditions

Following terms and conditions including the Service Level Agreement governs the Customer’s access and usage rights of the Catchtrial Software:

1. 1. DEFINITIONS

      1.1 “Account” means an account allowing access to the Catchtrial Software created in Customer’s name.
      1.2 “Confidential Information” means (a) all nonpublic information disclosed or made available under this Agreement that relates to the provision or use of the Catchtrial Software or either party’s financial condition, operations or business, and which is clearly identified as confidential at the time of disclosure, (b) the Catchtrial Software, (c) the Documentation, (d) the Customer Information; and (e) the User IDs.
      1.3 “Clinical Trial” means the clinical trial set forth on the Catchtrial Software.
      1.4 “Customer Information” means all clinical data, information or other content entered into, or collected from Customer or any other user of the Account while accessing, the Catchtrial Software.
      1.5 “Documentation” means the online help files and instruction manuals (whether in print or electronic form) that relate to the use of the Catchtrial Software that have been provided or made available by MediTrial to Customer.
      1.6 “Intellectual Property Rights” means any and all intellectual property rights throughout the world, including, without limitation, any and all copyrights, trademarks, service marks, trade secrets, patents, patent applications, moral rights, contract rights and any and all other legal rights protecting intangible proprietary information.
      1.7 “Support Services” means the support services offered by MediTrial, in relation to the Catchtrial Software, set forth in Catchtrial Service Level Agreement attached hereto.
      1.8 “User ID” means each unique User identification name and password used for accessing and using the Catchtrial Software through the Account.
      1.9 “User” means anyone accessing and using the Catchtrial Software through Customer’s Account.

   2. CATCHTRIAL SERVICES.

      2.1 Customer’s Right to Access the Services. Subject to the terms and conditions of this Agreement, MediTrial will provide Customer with the right to access and use the Catchtrial Software during the term of this Agreement, solely for Customer’s own internal purposes in connection with the Clinical Trial. Customer’s rights are non-exclusive, non-transferable and non-sublicensable. Customer may access and use the Catchtrial Software only as permitted by this Agreement. Customer acknowledges that Customer is not receiving any ownership interest with respect to the Catchtrial Software or Intellectual Property Rights related to the Catchtrial Software.
      2.2 Restrictions on Use of Services. Customer acknowledges that the Catchtrial Software (in source code and object code forms) including, without limitation, the structure, sequence and organization of the Catchtrial Software constitute valuable trade secrets of MediTrial. Customer will not, and will not permit any Users or any other party to: (a) alter, modify, reverse engineer, decompile, disassemble, or otherwise attempt to derive the source code of the Catchtrial Software or any part thereof; (b) interfere in any manner with the operation or hosting of the Catchtrial Software or attempt to gain unauthorized access to the Catchtrial Software or any other services offered by MediTrial; (c) sublicense or transfer any of its rights under this Agreement, including, without limitation, providing outsourcing, service bureau, commercial hosting, application service provider or on-line services to third parties, or otherwise make available the Catchtrial Software, or access thereto, to any third party; or (d) otherwise use the Catchtrial Software except as explicitly permitted by the Agreement.
      2.3 User IDs. Customer will be able to create one User ID for each User authorized to access the Catchtrial Software through the Account. Customer will be responsible for ensuring the security and confidentiality of all User IDs. Customer acknowledges that Customer will be fully responsible for all liabilities incurred through use of any User ID (whether lawful or unlawful) and that any transactions completed under a User ID will be deemed to have been lawfully completed by Customer. In no event will MediTrial be liable for the foregoing obligations or the failure by Customer to fulfill such obligations.
      2.4 Customer Equipment. Customer shall be responsible for obtaining and maintaining throughout the term of this Agreement, all computer hardware, software, communication lines, ports, interface equipment, terminals, internet access, bandwidth, network routing equipment, application licenses and other materials (“Customer Equipment”) necessary for each User to access and use the Catchtrial Software at Customer’s facilities.

   3. SUPPORT AND SERVICE LEVELS.

      3.1 Support Services. MediTrial will use commercially reasonable efforts to provide the support services to Customer, as described in Catchtrial Service Level Agreement.
      3.2 Service Level Agreement. MediTrial will use commercially reasonable efforts to make available the Catchtrial Software in accordance with the Catchtrial Service Level Agreement. Meditrial reserves the right at any time and from time to time to modify the Catchtrial Software and Service (or any part thereof). If MediTrial makes a material change to the Services, MediTrial will inform the Customer. A 30-day notice will be provided at any time by posting the changes to the Catchtrial Software and/or informing the Customer by e-mail. MediTrial shall not be liable in any way or on any legal basis to Customer or to any third party for any modification, price change, suspension or discontinuance of the Catchtrial Software. Any new features on the Catchtrial Software, including the release of new tools and resources, shall be subject to these Terms and Conditions. Continued use of the Catchtrial Software after any such changes shall constitute Customer’s legally binding consent to such changes.

   4. OWNERSHIP.

      4.1 Customer Ownership. Customer retains all right, title and interest in and to all the Customer Information. MediTrial will use the Customer Information solely to provide support services to Customer in connection with the Customer needs.
      4.2 MediTrial Ownership. MediTrial retains all right, title and interest in and to, and all Intellectual Property Rights embodied in or related to the Catchtrial Software and all improvements, updates, and modifications thereto, whether or not made in conjunction with this Agreement. Except as set forth in Section 2, this Agreement does not grant Customer a license to Catchtrial Software, or to any other software, by implication, by estoppel, or otherwise. The Catchtrial name, logo, and the product and service names associated with the Catchtrial Software are trademarks of MediTrial or third parties, and no right or license is granted to Customer to use them separate from Customer’s right to use the Catchtrial Software.

   5. FEES AND PAYMENT.

      5.1 Services Fees. In consideration of the use of the Catchtrial Software in connection with the Clinical Trial, Customer will pay the fees and other payments set forth in the applicable Service Level Agreement and Order Forms (“Fees”) when due.
      Services Fees depend on the Catchtrial solution (Prime, Extended, Magnum, Enterprise) selected by the Customer. The Customer can evaluate the monthly/yearly cost of the selected solution by consulting the “Solutions” page within Catchtrial. The “Solutions” page is also accessible by clicking here.
      In addition, any activity conducted by the Catchtrial Helpdesk following a Customer’s request will be charged at the hourly rate of 180,00 USD/hour, as specified in the online forms to be used in order to submit the requests (“Helpdesk” link within Catchtrial). Further details are reported in the section “Support Services” of this agreement.
      The Customer can request to upgrade the Catchtrial solution online, using the appropriate flags available in the “Solutions” page, or via Helpdesk, by contacting the e-mail support@catchtrial.com.
      Once an upgraded Catchtrial solution is released following the Customer’s request, an automated email is sent to the requester in order to confirm the activation. Once the activation is done, it is not possible to downgrade the selected solution for the entire duration of the contract.
      5.2 Payment. All fees must be paid in U.S. dollars. The invoice will be issued on the first day of each month and will cover the services purchased at the invoice date for the current month. In case of new services activation (i.e. solution upgrades), Customer will be charged in the first subsequent invoice.
      Any undisputed invoiced amounts, which are not paid within five (5) days of the invoice date shall be considered past due. Customer will notify MediTrial of any good faith dispute relating to any fees in writing on or before the date that is five (5) business days after the invoice date. Regardless of any reasonable dispute as to any fees on an invoice, Customer will pay all other non-disputed fees on such invoice (and all other non-disputed fees on every other invoice) not subject to a reasonable dispute, in accordance with the terms of this Agreement. Customer’s obligation to pay fees is not subject to a reasonable dispute will be unconditional and not subject to abatement, set off or defense of any kind. All fees are nonrefundable. Fees exclude all applicable sales, use, and other taxes, fees, duties and similar charges, and Customer will be responsible for payment of all such taxes (other than taxes based on MediTrial’s income), fees, duties, and charges. Any portion of the non-disputed fees not paid when due will accrue interest at 18% per annum (1.5% per month) or the maximum rate permitted by applicable law, whichever is less, from the due date until paid.

   6. TERM AND TERMINATION.

      6.1 Term. Unless sooner terminated as provided in this Section 6, this Agreement shall commence as described in Catchtrial Service Level Agreement. During the 30 days free trial period Customer is allowed to cancel without being charged. After 30 days the billing process will start as described in Catchtrial Service Level Agreement. Customer is solely responsible for properly cancelling its account. Customer is solely responsible for retaining and archiving all Content in its Account, prior to cancelling its account. When canceling Customer Catchtrial account: cancellation will end billing, changes will be immediately effective, all of Customer Catchtrial upgrades and features expire as soon as Customer cancellation request is received and the access to all created Catchtrial studies will be lost once Customer request is received and will not be granted back.
      6.2 Termination for Cause. This Agreement will automatically terminate if Customer breaches a material term of this Agreement, and such breach is not cured within five (5) days after Customer receives written notice from MediTrial of such breach. If MediTrial breaches a material term of this Agreement, and such breach is not cured within five (5) days after MediTrial receives written notice from Customer of such breach, Customer may terminate this Agreement upon notice to MediTrial, with immediate service suspension.
      6.3 Suspension. MediTrial may suspend the Services, or any portion thereof, or this Agreement for material breach including without limitation any breach of the payment obligations set forth in Section 5, with advance written notice of five (5) business days. MediTrial is not required to refund any fees paid or prepaid after such suspension.
      6.4 Effect of Termination or Expiration. Upon any termination or expiration of this Agreement, (a) all rights and licenses granted to Customer in this Agreement will immediately cease to exist, (b) MediTrial may promptly cease performing all obligations under this Agreement, (c) all access by Customer and any Users of the Catchtrial Software will be immediately suspended, and (d) Customer will pay MediTrial any amounts payable for Customer’s use of the Catchtrial Software through the end of the term.

   7. OBLIGATIONS.

      7.1 Customer obligations. Customer agrees to disclose to MediTrial only that portion of Customer’s Confidential Information that is reasonably necessary to enable MediTrial to provide the Services, and MediTrial agrees to disclose to Customer only that Confidential Information of MediTrial that is reasonably necessary to enable Customer to receive the Services.
      Customer confirms that all the information and details provided are true, accurate and up-to-date in all respects and at all times.
      In relation to any material submitted to the Catchtrial Software, Customer has the right to do so and has obtained all necessary licenses and or approvals. Customer will be sole responsible for all the Contents and activities taken place under the account.
      Customer will notify immediately to MediTrial of any unauthorized use of any account or any other known breach of security.
      Customer shall be solely responsible for the User Generated Content and the consequences of posting, publishing, or otherwise distributing it.
      MediTrial does not claim ownership in User Generated Content that Customer submits. Customer agrees that will not upload content or distribute anything that may be harmful to minors or that violates these Terms and Conditions. MediTrial does not verify Content. In any case MediTrial has the right, but not the obligation, in its sole discretion to refuse or remove any Content that is available on the Catchtrial Software.
      7.2 Customer Conduct. Customer shall use the Catchtrial Software only for lawful purposes and in accordance with these Terms and Conditions of use. Customer agrees to use the Catchtrial Software (or any part of it) in accordance with all applicable laws relevant to the jurisdiction from which Customer access the Catchtrial Software. Customer agrees that in using the Catchtrial Software (or any part thereof) will not:

      7.2.1 use the Catchtrial Software in any way that may lead to the encouragement, procurement or carrying out of any criminal or other activity that violates any applicable federal, state, local and international law or regulation;
      7.2.2 use the Catchtrial Software in a manner that infringes the rights of another person, firm or company (including, without limitation, the intellectual property rights, confidentiality rights or rights of privacy);
      7.2.3 use the Catchtrial Software to impersonate or attempt to impersonate MediTrial or one of its employees, another user or person or entity (this includes, without limitation, the use of email-addresses associated with any of the foregoing);
      7.2.4 transfer files to or through the Catchtrial Software that contain viruses, Trojans, worms or anything else that is malicious or technologically harmful or that may interfere with, interrupt or disrupt the normal operation of the Catchtrial Software;
      7.2.5 use the Catchtrial Software in a way to cause it to be interrupted, overburdened, damaged, rendered less efficient or in a way so that the effectiveness or functionality of the Catchtrial Software is impaired;
      7.2.6 use the Catchtrial Software to send any unsolicited advertising or other promotional material or any form of solicitation by email or by any other means;
      7.2.7 do anything that would seek to bypass or interfere with any security features of the Catchtrial Software, or interfere with any of MediTrial (or MediTrial affiliated companies) websites, servers, or network;
      7.2.8 use any robot, spider or other automatic device, process or means to access the Catchtrial Software;
      7.2.9 copy, reproduce, duplicate any of the material on the Catchtrial Software without MediTrial express prior written consent;
      7.2.10 upload files which contain an active hypertext link to another website;
      7.2.11 phish, collect, upload, post, email, transmit or otherwise make available any login data and/or passwords for other web sites, software or services, credit card information or other forms of financial data used for collecting payments.

      7.3 User Generated Content. By using the Catchtrial Software, Customer may create certain templates, graphics or documents and load or post such documents on catchtrial.com for other users. By submitting User Generated Content to the Site, Customer automatically grants MediTrial a perpetual, worldwide, non-exclusive, royalty-free, and transferable license to use, reproduce, distribute, sublicense, modify, create derivative works of, publish, transfer, transmit, publicly display, publicly perform, host, index, cache, tag, encode, and/or adapt the User Generated Content in any and all media formats without payment and without further consent or notice to Customer. Customer further grants MediTrial the right to be contacted in connection with its User Generated Content and to use its name, city, and state or province and other information that Customer has provided in connection with the User Generated Content. MediTrial does not endorse any User Generated Content or any opinion, recommendation, or advice expressed therein. MediTrial expressly disclaims any and all liability in connection with User Generated Content.

   8. REPRESENTATIONS AND WARRANTIES.

      8.1 Limited Warranties. MEDITRIAL PROVIDES THE CATCHTRIAL SOFTWARE “AS IS” AND TO THE MAXIMUM EXTENT PERMITTED BY LAW, SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, REGARDING THE CATCHTRIAL SOFTWARE, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT. CUSTOMER ACKNOWLEDGES THAT IT HAS RELIED ON NO SUCH WARRANTIES IN ENTERING INTO THIS AGREEMENT. FURTHER, MEDITRIAL DOES NOT WARRANT, GUARANTEE OR MAKE ANY REPRESENTATION REGARDING THE USE, OR THE RESULTS OF THE USE, OF THE CATCHTRIAL SOFTWARE IN TERMS OF CORRECTNESS, ACCURACY, RELIABILITY OR OTHERWISE.

   9. INDEMNIFICATION.

      9.1 MediTrial will, at its own expense, defend Customer and pay all costs and damages awarded against Customer based on any third party claim that authorized use of the Catchtrial Software by Customer infringes any copyright or misappropriates any trade secrets. MediTrial’s obligation will not extend to a claim based on any alleged infringement arising from any: (a) additions, changes or modifications to the Catchtrial Software by or on behalf of Customer; (b) use or incorporation of the Catchtrial Software or any component thereof with or into any other service, product or process; (c) Customer Information or Confidential Information provided to MediTrial by Customer; or (d) use of the Catchtrial Software other than as permitted by this Agreement.

   10. ASSIGNMENT.

       10.1 Customer may not assign, resell or otherwise transfer any goods or services received under this Agreement to a third party without the prior written consent of MediTrial. Any assignment in violation of this Section 10 is null and void.

   11. GENERAL TERMS.

       11.1 This Agreement will be governed by the laws of Switzerland without regard to conflicts of law principles. All disputes arising under this Agreement must be brought in the courts of competent jurisdiction located in Switzerland if brought by Customer and in Customer’s principal place of business, if brought by MediTrial. Each party irrevocably hereby consents to the jurisdiction and venue of any such court in any such action or proceeding.

Catchtrial Service Level Agreement (SLA)

Catchtrial is a powerful and easy to use cloud-based tool for creating studies and clinical trials. Customers can easily build and manage their own study without any technical skills, thanks to the friendly “drag and drop” interface. This Service Level Agreement (“SLA”) addresses MediTrial’s performance of the Support Services and the service levels with respect to the Services under this Agreement.

CATCHTRIAL ACCOUNT

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• In order to open an Account on the Catchtrial Software, you must (a) agree to the Catchtrial License Agreement; (b) provide a valid e-mail address; and (c) provide any other information required by MediTrial during the registration process. You will update this information to maintain its accuracy during the term of this Service. You are responsible for maintaining the security of your account and password. MediTrial cannot and will not be liable in any way for any loss or damage (including, without limitation, loss of profits, loss of revenues, loss of business and loss of privacy) whether direct, indirect or consequential, resulting from your failure to comply with this security obligation.
• You are also solely responsible for all content that you opt to make available on the Catchtrial Software (“Content”) and activity that occurs under your Account (even when Content is posted by others who have accounts under your Account). Personally identifiable information submitted by you shall be subject to the Privacy Policy of MediTrial.
• One person or legal entity may not maintain more than one free Account. Any such duplicate Accounts will be terminated immediately if discovered at MediTrial’s sole discretion. Accounts registered by “bots” or other automated methods are not permitted and will be terminated immediately if discovered at MediTrial’s sole discretion.
• Each Account is assigned a unique name and password which is required to access the Account. This information is confidential and should be treated as you treat any other confidential information and in any event with a reasonable degree of care.

OWNERSHIP OF STUDY DATA

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• All the information, data and results of the studies managed with Catchtrial remain exclusive ownership of the Sponsor, who has the authority to determine the modalities of data utilization, distribution and maintenance.
• Access, analysis or use the study data is not permitted to any party without prior written authorization from the sponsor, except for the visualization and uses that are necessary for Catchtrial development and maintenance.
• Catchtrial will remain exclusive ownership of MediTrial Europe Ltd.

DOWNTIME AND MAINTAINANCE

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• “Excused Downtime” means anytime the Services are not available for access that (i) occurs during a Scheduled Maintenance Period or (ii) is caused by: (A) Customer’s or a Users’ telecommunications and Internet services, (B) services, software or hardware not provided and controlled by MediTrial (including third-party services, software or sites that are accessed or linked through the Services), or (C) force majeure events.
• “Scheduled Maintenance Period” means any time period during which MediTrial performs scheduled or emergency maintenance on the Services.

SERVICE LEVEL

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• MediTrial will use commercially reasonable efforts to cause the uptime for the Services to be no less than 99.9%, excluding Excused Downtime.
• MediTrial shall provide an advanced notice of at least two (2) business days to Customer for any scheduled maintenance.

SUPPORT SERVICES

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• The Support Services provided under this Agreement (the “Support Services”) will include online support available during MediTrial’s normal business hours (9 AM to 6 PM CET, from Monday to Friday) with the exception of MediTrial holidays.
• Helpdesk requests management and costs are described below:

A. Problem management (e.g. technical issue, server issue, user unable to login, etc..):

B. Support request (e.g. technical check, verification of study setting, answer Customer’s questions, training, etc..):

• Any Support Services provided by MediTrial to Customer after normal business hours, or during MediTrial’s holidays or other periods of closure will be charged at MediTrial’s then-current rates and costs.
• The Support Services will be provided only for those issues forwarded to MediTrial from Customer’s designated staff and entered via the Customer support portal. Customer must provide MediTrial with accurate and complete information regarding each issue logged by Customer, including without limitation designated points of contact and passwords for maintenance and repair use by MediTrial support agents. MediTrial will not be responsible for any delays or failures caused by Customer’s failure to abide by the requirements of this Section 3.2. MediTrial may reclassify any case misclassified as falling into one of the severity categories listed below.
• The Support Services are offered to Customer on a commercially reasonable-efforts basis only. Customer acknowledges that MediTrial may not be able to resolve every request for support through the Support Services. Customer’s exclusive remedy and MediTrial’s sole obligation for any failure to resolve a request shall be to use commercially reasonable efforts to resolve such request. In the event that the request for support is not covered by the Support Services, Customer may have to purchase additional services from MediTrial. Any additional services are made available upon agreement by MediTrial at MediTrial’s then-current rates. The Support Services are provided for on-going use of the Catchtrial Software; they are not intended to be a substitute for the professional services or training. All other services, including without limitation, on-site assistance, custom programming, database and network administration, and custom designed reports and forms, may be furnished by MediTrial at MediTrial’s then-current rate.
• As part of Support Services, MediTrial will investigate all reproducible, material failures of the Catchtrial Software to conform to the functional specifications as described in the applicable Documentation. MediTrial will classify the severity of the error, provide efforts to correct the error or provide a workaround to the error as defined in the table below.

 

Software Issue Classifications

 

• The ticket response time is based on the applicable Service Level Agreement, which includes three (3) profiles as shown in the table below:

SLA	Type of contract	Availability	Response time
Light	E-mail/Web	8×5 CET	12 Working hrs
Premium	E-mail/Web	8×5 CET	6 Working hrs
Power	Phone/E-mail/Web	8×5 CET (*)	Immediate (by phone) 3 Working hrs (e-mail/web)

(*) Alternative time zones can be agreed with MediTrial based on the Sponsor requirements.

SECURITY

• MediTrial holds the following certifications:
  • ISO 9001:2015 compliant to provide solutions in Electronic Data Capturing (EDC) and Clinical Data Management and to provide training to customers and end-users.
  • ISO 27001:2013 compliant for design, development, deployment, support and maintenance of clinical software products.
• The Catchtrial Software is designed to meet the system requirements of 21 CFR part 11 and those defined in EU Annex 11.
• The Catchtrial Software is hosted on Google Cloud Platform and provides scalable, durable cloud storage, backup and recovery solutions.
• The Catchtrial Software is accessed through a secure internet connection (https) and makes use of Secure Sockets Layer (SSL) encryption technology to secure internet communication.
• MediTrial shall employ generally prevalent industry security standards, protocols and practices to prevent unauthorized intrusion into or interception of data communications by unauthorized third parties in order to maintain the security and integrity of the Customer Information and User IDs. MediTrial shall promptly notify Customer in the event of any such intrusion or interception.

QUESTIONS

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• Questions about the Service Level Agreement may be addressed to legal@meditrial.net

Version 4 updated on November 30th, 2019