These Online Service Terms & Conditions apply to licensing and use of the SMART-TRIAL services and products between us (SMART-TRIAL ApS, CVR no. DK-35139710, K. Christensens Vej 2L, 9200 Aalborg SV Denmark, hereinafter “Licensor”) and you (hereinafter “Licensee”). These Online Service Terms & Conditions apply unless they are superseded by a written agreement.
This document uses the following definitions:
2.1 Licensee may accept a license quote from Licensor which specifies the SMART-TRIAL services requested by Licensee and details on all fees.
2.2 License quote can be in the form of a license quote document from Licensor, a purchase order from Licensee, or other kind of order confirmations in writing, for example via email.
2.3 A license quote from Licensor is valid for 14 days from the date of issue unless otherwise stated. Acceptance of a license quote received by Licensor after the validity date is not considered binding unless it is confirmed in writing by Licensor.
2.4 Licensee cannot modify a license quote from Licensor, without Licensor’s written consent.
3.1 A Licensee is entitled to technical support from Licensor during standard service hours between 09:00 and 17:00 o’clock Monday through Friday and between 12.00 and 16.00 on Sunday’s (CET).
3.2 Support is only given in relation to usage of the SMART-TRIAL product and services and not in relation to any of Licensee’s computer equipment, browsers, applications, etc.
3.3 Support inquiries shall be requested by emailing SMART-TRIAL customer support directly via email@example.com.
3.4 Licensee is entitled to technical support for all of Licensee’s study/project staff/users using SMART-TRIAL, from sponsor, to monitors, and all site(s) staff/users (investigators etc.) – but not any study patients/subjects.
3.5 SMART-TRIAL service level, quality, uptime, backup, and other failover procedures are provided according to the SMART-TRIAL Security & Service Level Statement.
4.1.1 Upon acceptance of a quote, the Licensee achieves a limited and non-exclusive right to use SMART-TRIAL features and eventual selected add-ons in accordance with the license quote and T&C. Licensee is also entitled to receive any subsequent system updates to these features and eventual selected add-ons, in accordance with the T&C.
4.1.2 The rights of use solely grant the Licensee to use the Licensed Product in relation to normal usage of the Licensed Product, when structuring and planning data-collection projects, as well as to collect, store, and export data on people/patients/trial-subjects. The Licensed Product can be used for Licensee’s collection of personal data, including sensitive personal data, which entails that Licensor processes personal data on behalf of Licensee. The Standard Contractual Clauses (data processor agreement) in Appendix 1 apply to such processing of personal data on behalf of Licensee. If Licensee is an entity established outside the EU/EEA in a country which is not approved by the EU Commission as a non-European country offering an adequate level of data protection in accordance with GDPR article 45, the Standard Contractual Clauses in Appendix 2 apply to the transfer of personal data from Licensor to Licensee.
4.1.3 The content of Appendix 1 and 2 reflect the standard configuration of the Licensed Product. Licensee acknowledges that Licensee is solely responsible for any derogations from the standard configuration which affect the processing of personal data through the Licensed Product, including, but not limited to, any insufficiencies in Appendix 1 or 2 resulting from Licensee’s derogation from the standard configuration.
4.1.4 Licensee acknowledges that Licensee as data controller in relation to Licensee’s use of the Licensed Product has the sole responsibility for complying with Licensee’s obligation to inform data subjects subject to Licensee’s processing of personal data via the Licensed Product of the processing in accordance with Article 13 and 14 GDPR. This includes any participants in clinical trials, users and other affected data subjects.
4.1.5 Licensee may not grant access to SMART-TRIAL or other Licensor’s Intellectual Property (as defined in section 7.0 below) to any third parties that compete with Licensor. Third parties that develop software platforms for collection of data in clinical studies or clinical investigations are considered competitors in this relation.
4.1.6 SMART-TRIAL is provided as a service, but neither source nor object code of the software used to provide the service is delivered or licensed to the Licensee or any user, nor is the Licensee or any Users entitled to access to such software source code.
4.2.1 Licensee is responsible for providing and installing the necessary browser software for presentation of the Licensed Product. Licensee recognizes that the usage of the SMART-TRIAL is dependent on the Licensee’s choice of browser software. Licensee can obtain information of which browser software can be used to display in the SMART-TRIAL Security & Service Level Statement. Licensor is entitled, without notice, to change its software with the effect that Licensee is required to obtain and install a new browser software as required. Licensee is also responsible for connecting to Licensor’s servers and reestablishing and maintaining such a connection.
4.3.1 Licensee is committed to ensure that Licensee’s Users are informed of, and comply with, the T&C, and to respect Licensor’s intellectual property rights, hereunder copyright. Licensor is entitled at any time to review Licensee’s usage of SMART-TRIAL to ensure that the T&C are complied with.
5.1 SMART-TRIAL is provided during the term of this T&C on a 24/7 basis according to the service availability set forth in the SMART-TRIAL Security & Service Level Statement, it being understood that the services may be inaccessible or inoperable from time to time for any reason, including, but not limited to:
5.2 Licensee agrees that Licensor has no control over the stability and throughput speed of the Internet or other data transmission systems used by Licensee or any 3rd party provider.
5.3 Licensor‘s service targets follow the SMART-TRIAL infrastructure provider (Microsoft Azure) which is set at 99.9% availability.
5.4 Licensor is not responsible for making SMART-TRIAL available under the following conditions:
5.5 However, Licensor can in no case, except for gross negligence and intent, be obliged to provide Licensee with compensation greater than 75% of one-twelfth of the annual remuneration.
5.6 Licensee’s exclusive remedy and Licensor’s sole liability under this T&C shall be for Licensor to correct any material failure of SMART-TRIAL to perform as promised, if Licensee at Licensor ‘s request, provides Licensor with sufficient information (which may include access to Licensee’s computer system to reproduce the defect in question). In the event that Licensor cannot, after repeated efforts, remedy such failure, Licensor shall refund all payments received by Licensor from Licensee hereunder and terminate this T&C, and Licensee’s use of SMART-TRIAL shall terminate.
6.1 Licensor has rights to regularly update and amend SMART-TRIAL when Licensor deems it necessary. Such an update or amendment do not restrict or provide changes in Licensee’s obligations to Licensor. Furthermore, such updates or amendments to SMART-TRIAL do not provide Licensee with a right to claim breach of contract against Licensor.
6.2 Licensor is also entitled to make changes to the functionality of SMART-TRIAL, including removal and or changes in functions, which Licensor deems necessary to provide the best possible service to its customers. Only Licensor determines the functionalities, which meet this requirement. Such changes in the functionality of SMART-TRIAL entails no restrictions or changes in the Licensee’s obligations to Licensor, such as any changes of SMART-TRIAL do not give Licensee the right to claim breach of contract against Licensor.
7.1 Licensor retains full ownership of SMART-TRIAL and is entitled to occupy SMART TRIAL with no restrictions of any kind from the Licensee or from any third party.
7.2 Should Licensee require any additional consulting services in relation to future use of SMART-TRIAL, shall such services be agreed upon separately in writing between the parties.
7.3 Licensee is not allowed to use SMART-TRIAL in such a way that it violates Licensor’s rights, or in other way harms Licensor.
7.4 Licensor collects and processes Customer Data for security reasons and to improve SMART-TRIAL and its related services. For the avoidance of doubt and for the purpose of this section, the Customer Data shall mean only data concerning the Licensee and shall exclude any data that the Licensee is collecting from its clients.
7.6 Licensor has the right to, with written consent from Licensee, to refer to Licensee’s use of SMART-TRIAL, e.g. by displaying Licensee’s logo or name on the SMART-TRIAL website etc.
8.1 Transfer of rights and obligations under the T&C to any third party cannot take place unless agreed in writing.
8.2 Licensor is not entitled to assign or re-assign the License to a third party except as part of a merger & acquisition of Licensor or SMART-TRIAL. Licensee is not entitled to terminate the contract on the sole basis of such an event.
9.1 The license fees and any additional service fees shall follow the pricing depict in the license quote from Licensor.
9.2 Unless otherwise stated in the license quote, the initial and minimum License Period is one (1) calendar month (or 30 days) and the License will be renewed automatically at the end of each License Period unless cancelled.
9.3 If not stated otherwise in the license quote, license fees shall be invoiced up-front for each License Period.
9.4 License is required for ongoing Studies, i.e. SMART-TRIAL Studies that are in "Collecting Data", "Amendment", or "Completed" modes. Archiving fee is required for SMART-TRIAL Studies in "Locked" or "Archive" mode.
9.5 Upon renewal of the License Period Licensor may amend the license fees according to Licensor’s current list price. If this amendment applies to Licensee, Licensor will notify Licensee at least thirty (30) days in advance of the renewal and the amended license fees will apply at the start of the next License Period. If Licensee does not agree to the amended license fees, either party can choose to terminate these T&C in accordance with section 10.0.
9.6 If not stated otherwise in the license quote, a License Period starts as soon as a Study is started (i.e. placed into “Collect Data” mode) and License renewal can only be cancelled by placing a Study into “Archive mode”, deleting the Study, or by written notice to firstname.lastname@example.org from Licensee at least 15 days prior to the end of the current License Period.
9.7 Licensor does not refund license fees for an unused License Period.
9.8 Studies in “Archive Mode” require an Archive license which is invoiced up front for 12 months at a time, unless otherwise stated in the license quote.
9.9 The terms of payment for all invoices delivered to Licensee are NET 8 days from the date of invoice, unless otherwise stated in the license quote.
10.1 These T&C may be terminated by either party with a 15 day prior notice to the end of the current license period. Notification of termination of contract must be addressed in writing to email@example.com. All terms of this contract still apply during the notice period.
10.2 In the case where either Party terminates the T&C, Licensor shall store data for 3 months, after which they will be permanently deleted.
10.3 Licensor does not refund payments for a License Period upon termination.
11.1 In the case where one of the parties breaches the terms set in this T&C or the associated Online Data Processing Terms (Appendix 1 or 2), the other party is entitled to terminate the T&C instantly.
11.2 In the case that the T&C are terminated as a result of a breach, Licensor shall store data for 3 months, after which the data will be permanently deleted.
12.1 Technical information, know-how, concepts, methods, intellectual property rights and related information, which is developed or owned by Licensor is regarded as Licensors trade secrets.
12.2 The data on Licensee products, protocol procedures, and subject specific data shall be regarded as confidential information and is owned by Licensee. All intellectual property rights evidenced by or embodied in the Data shall be owned solely by the Licensee.
12.3 Each Party is obliged to keep all information they receive about each other confidential. This shall be the case whether the T&C have been terminated or not.
12.4 The Parties are entitled to disclose sensitive information to its employees and own advisors on a “need to know” basis to the extent that disclosure meets the purpose of the present T&C.
13.1 Licensor is responsible for product liability in accordance with the Danish Product Responsibility Act (produktansvarsloven) but does not assume any liability to any extent beyond what is stated in the statutory responsibility. Licensor shall obtain the required product liability insurance to comply with its obligations under this Agreement.
13.2 Licensor shall not be liable to Licensee for any indirect or consequential damages arising from SMART-TRIAL, including operating losses, loss of anticipated profit, penalties, loss and/or damage of data, loss of goodwill as well as all other forms of consequential damages.
13.3 Except for losses which result from Licensor negligence of willful misconduct, Licensor is not responsible for losses that might arise as a result of Licensee’s inability to use SMART-TRIAL, regardless of the cause hereof and regardless of Licensor previously being advised of the possibility of such as loss.
13.4 Except for losses which result from Licensor negligence of willful misconduct, Licensor’s liability for loss or damage shall in no event exceed an amount equivalent to the license fee that Licensee has paid to Licensor in the license period during which the damage may have occurred.
13.5 Licensor disclaims any liability for loss or damage attributable to Licensee’s own connection to Licensor’s services, including lack of connectivity, system crashes, etc. This also applies to Licensee’s other computer equipment, browser software, etc.
13.6 Licensor disclaims any responsibility for seeking informed consent to the processing of personal data by Licensee’s patients/research subjects, and related tasks.
13.7 Licensee’s breach of terms gives Licensor rights, in addition to fees for incorrect/unauthorized use of SMART-TRIAL, to claim compensation in accordance with Danish Law.
14.1 Neither Party shall, in relation to the present T&C, be held responsible for the other Party in respect to matters which are beyond the Party’s control and which the Party could not have taken into account when accepting the T&C and could not have avoided or overcome. These matters include but are not limited to strike or other workforce related complications, over which the Parties have no control, fire, war, riot, mobilization or unforeseen military calls, monetary restrictions, lack of transport, lockouts, limit of products, restriction of assets, shortcomings in delivery, virus in SMART-TRIAL, or delays from sub-contractors.
15. 1The present T&C are subject to Danish Law. Any disputes arising in connection with the T&C, including disputes regarding its existence or validity, shall be settled by the court of Aalborg (Byretten i Aalborg).
16.1 Once a year, Licensee shall have the right to request a copy of an internal audit report from Licensor, in order to verify compliance of the Licensor with the T&C and the quality, technical, service, and security measures described in the SMART-TRIAL Security & Service Level Statement and SMART-TRIAL’s GCP, FDA 21 CFR Part 11, and HIPAA Compliance Statement
16.2 Licensee can request access to Licensor's compliance facilitation documentation depot, which contains documents to verify Licensor's compliance towards regulatory frameworks and industry standards.