TOC, EULA & DPA

General terms and conditions

These general terms and conditions (the “General Terms and Conditions”) apply to all services and products delivered by Cortrium ApS, CVR no. 36445335 (“Cortrium”), to the Customer unless otherwise agreed in writing in the Customer Agreement entered into between Cortrium and the Customer (each a “Party” and combined the “Parties”).

Cortrium manufactures an ECG recorder (Holter Monitor) that monitors and records heart rhythms (the “Device”). The data recorded by the Device are subjected to cloud-based algorithms and expert analytics through Cortrium’s proprietary administration system, APEX, where the Cortrium delivers the result of the analysis in the form of reports (“Reports”).

Defined terms in the Customer Agreement shall have the same meaning in these General Terms and Conditions, unless otherwise explicitly is set forth herein.

  1. CONTRACTUAL RELATIONSHIP
  2. References herein to the Customer Agreement shall mean the Customer Agreement and any of its appendices, including these General Terms and Conditions. The signed Customer Agreement including its appendices and these General Terms and Conditions form the entire contractual basis for the relationship between Cortrium and the Customer.
  3. Depending on the model agreed between Cortrium and the Customer in the Customer Agreement, the Customer (i) subscribes for Reports, (ii) subscribes for the Device(s), (iii) subscribes for both Reports and Device(s), or (iv) purchase Device(s). The Customer can, if this is agreed in the Customer Agreement, choose to subscribe for the Device or purchase the Device and extract data as a self-service, without subscribing for Reports. The Customer can, if this is agreed in the Customer Agreement, choose to subscribe for Reports, and within such subscription include subscription for Device(s) as a minor but necessary and integrated part of the service.
  4. DEVICE DELIVERY AND QUALITY
  5. Device Delivery
  6. Any Device(s) subscribed for or purchased in accordance with the Customer Agreement will be delivered at the registered address of the Customer on or before the Expected Delivery Date. If it becomes apparent, that delivery of the Device(s) is not possible on or before the Expected Delivery Date due to supply chain issues or otherwise, Cortrium will notify the Customer immediately and provide the Customer with a new expected date of delivery.
  7. Upon delivery, the Customer must immediately inspect the Device(s) for defects and, without undue delay, report in writing any such defects to the Device(s) to Cortrium. If no defects have been reported in writing within 15 business days from the date of delivery, the Device(s) shall be considered accepted by the Customer free of any defects.
  8. If, upon delivery, the Device(s) is/are defective, Cortrium shall be entitled (and obligated) to replace the defective Device(s) with a Device free of defects within 30 days of having received notice of the defect (the “Replacement Date”).
  9. The Customer is responsible for the installation of the Device. Customer online support service is available through Cortrium’s website.
  10. Device quality
  11. The Device(s) is/are delivered in a condition that is compliant with laws and regulations applicable for usage in the healthcare sector in the territory of the Customer, including but not limited to MDR.
  12. The Device(s) perform(s) as specified in the Instruction-for-Use (IFU) as well as other user documentation provided. The Customer acknowledges that minor deviations, not materially affecting the use or reliability of the Device(s) must, to some extent, be expected and that such deviations shall not constitute defects.
  13. Further, the Customer acknowledges that performance of the Device(s) may be affected by e.g., software interactions, quality of data recordings as well as other factors outside Cortrium’s control. Such factors outside Cortrium’s control shall not constitute defects.
  14. If a Device becomes defective, the Customer shall immediately notify Cortrium in writing and describe the defect. Cortrium shall replace the defective Device in accordance with clause 2.1.3. A defective Device shall not entitle the Customer to withhold any payment pursuant to clause 5 or to terminate this Customer Agreement. Defective shall in this context mean that a Device no longer functions in accordance with its intended use. Purely cosmetic deterioration or wear and tear shall not constitute a defect.
  15. DEVICE WARRANTY AND SUBSEQUENT REPAIRS
  16. Cortrium warrants to the Customer that the Device shall be free from defects in material and workmanship under normal use and service for a period of twenty-four (24) months from the date of delivery to the Customer (the “Warranty Period”).
  17. During the Warranty Period, Cortrium shall, at its sole discretion, either repair or replace, free of charge, any Device that is found to be defective in material or workmanship. This warranty shall not apply to any Device that has been subjected to misuse, neglect, accident, improper installation or unauthorized modification.
  18. To obtain warranty service, Customer must notify Cortrium in writing within the Warranty Period, providing a detailed description of the alleged defect, the circumstances surrounding the defect, and any actions taken by the Customer in response to the defect. Valid warranty service claims will be paid by Cortrium. Cortrium reserves the right to charge the Customer if the warranty claim turns out to be invalid, specifically for logistics costs, inspection cost and any potential replacement which has been sent back to the Customer as part of the warranty service claim.
  19. Cortrium warrants to the Customer that it shall maintain adequate spare parts and capacity to repair and support the Device for a period om minimum 5 years from the date of each delivery under the Agreement. If such repairs are not performed under the warranty as set out in clauses 3.1 – 3.3, repair shall be charged to the Customer (as applicable) in accordance with Appendix 1 (Fees) to the Customer Agreement.
  20. THE SERVICES
  21. The Customer Agreement set forth the services to be delivered by Cortrium to the Customer. The agreed type of service determines the specific work to be performed and delivered by Cortrium as well as the content of the Report, if relevant. Only one of the below two options can be agreed in the Customer Agreement.
  1. Self-Service, where the Customer extracts the data from APEX, as uploaded from the Device(s). In this case no Report is issued by Cortrium. Self-service is a technical health care service and not a medical treatment of the Customers’ patients.
  2. CortriumAnalysisService, where the data from the Device transferred via APEX, is analyzed by Cortrium through its cloud-based algorithms and analyzes it by specialists who issue a Report to the Customer. Such service is a technical analytical health care service and not a medical treatment of the Customers’ patients.
  3. Both Self-Service and Cortrium Analysis Services are delivered only to Customers who are registered as a health care provider and a legally registered business. Cortrium does not offer any of its services or products, including the Device, commercially to any physical persons.
  4. SERVICES TEAM
  5. The services delivered by Cortrium to the Customer will be performed by a qualified team consisting of health care professionals (as nurses or doctors) within the field of cardiology.
  6. CUSTOMER OBLIGATIONS AND WARRANTIES
  7. The Customer warrants to Cortrium that the Customer (i) is a legally registered business, (ii) is operating as a health care provider and registered as such, and (iii) will solely use the Device and Reports for therapeutical purposes of diagnosing and planning medical treatment of the Customers’ individual patients as part of the Customers’ provision of health care.
  8. If the Device(s) are subscribed for by the Customer (i.e. not purchased), the Customer acknowledges that the Device(s) at all times remain(s) the exclusive property of Cortrium and no rights of ownership to the Device(s) is transferred or purported to be transferred under the Customer Agreement unless otherwise specifically provided for in the Customer Agreement.
  9. If the Device(s) are subscribed for by the Customer, the Customer shall take out and maintain adequate insurance covering the Device(s) in the Customer’s custody. Such insurance must provide cover for the Device’s accidental destruction (e.g. fire, flood or similar) and theft.
  10. If the Device(s) are subscribed for by the Customer, the Customer undertakes at its own expense to clean, reasonably maintain and take due care of the Device(s) to ensure proper functioning of the Device(s).
  11. The Customer is obligated to comply with any requirements under applicable statutory law and medical regulation. Further, the Customer undertakes to ensure that any end-user’s use of the Device(s) is compliant with requirements under applicable statutory law and medical regulation.
  12. The Customer must ensure that any end-user is covered by adequate patient insurance prior to such patient’s use of the Device(s).
  13. In the event of an incident leading to the death or serious deterioration of the health of a patient or any other person in contact with the Device, the Customer must inform Cortrium hereof in writing no later than 24 hours after becoming aware of the incident.
  14. In the event the Customer becomes aware of any unintended use of the Device (by the Customer or otherwise), the Customer must report such unintended use immediately and no later than 24 hours after becoming aware of the unintended use.
  15. The Customer warrants to be in possession of all required authorizations from authorities, health insurers and/or other relevant associations to conduct medical treatment of patients. Further, the Customer undertakes to maintain all authorizations from authorities, health insurers and/or other relevant associations for the duration in which the Customer is a customer of Cortrium.
  16. The Customer undertakes to indemnify and hold Cortrium harmless against any claim arising out of or as a result of the Customer’s omission of one or more of the undertakings/obligations in clauses 6.1 through 6.9.
  17. PAYMENT TERMS
  18. The Customer shall pay the Fees for subscription for Reports ordered in APEX, in accordance with the type of service agreed in the Customer Agreement and the Fees set out in Appendix 1 (Fees) to the Customer Agreement. One-off amounts, as set out in order confirmations from Cortrium (i.e., for purchases of Devices), are invoiced immediately upon conclusion of the Customer Agreement with a payment term of 21 days. Fees for subscription are invoiced no later than on the 9th of each month and shall become due and payable on the first business day (i.e., where banks are generally open for business) of the following month.
  19. All amounts stated in Appendix 1 to the Customer Agreement, order confirmations and otherwise is exclusive of any VAT unless stated otherwise.
  20. If the Customer fails to make any payment when due, without prejudice to any other right or remedy available to Cortrium, Cortrium may: (a) suspend further deliveries of Reports; (b) charge interest on the overdue amount at the rate of 10% per annum above the base lending rate of Danish Central Bank (in Danish: Nationalbanken) from the due date until payment is made in full in addition to charging a late payment fee of EUR 35 and/or (c) terminate the Customer Agreement.
  21. INTELLECTUAL PROPERTY RIGHTS
  22. All intellectual property rights and other rights, including without limitation patents, utility models, design rights, trademarks, copyright and know-how, in and to the Device, its components, software and any documentation related hereto, remain the sole property of Cortrium or its licensors. The Customer agrees to respect such intellectual property rights whether registered or not.
  23. The Customer shall not reverse engineer, disassemble or decompile the Device and/or its software or any parts thereof, except where and only to the extent that such operations are required according to the applicable mandatory, statutory legislation and subject to Customer’s compliance with all aspects of such legislation.
  24. LIABILITY AND LIMITATIONS
  25. Cortrium’s liability for breach or non-performance of the Customer Agreement shall be limited to direct losses. Under no circumstances shall Cortrium be liable for any indirect loss, including but not limited to, operating losses, loss of data, damage to records or data, or consequential damages.
  26. In no event shall Cortrium’s aggregate liability for damages or losses exceed the total of all invoiced and paid amounts under the Customer Agreement for a trailing 6-month period from the date on which the loss occurred.
  27. The Customer acknowledges that the Device provides data which can be used as only one of several input when diagnosing the Customer’s patients. Diagnosing of patients must always be carried out by competent licensed healthcare professionals employed with the Customer, who shall bear the full liability for such diagnosis. The Customer warrants that it shall indemnify and hold Cortrium harmless against any third-party claims or liability raised against Cortrium related to the Customer’s diagnoses, unless such claim or liability is directly attributable to an act or omission constituting gross negligence or willful misconduct by Cortrium.
  28. Cortrium is not liable for any representations, including without limitation, statements on the Device’s usability, quality or functionality, made by any third-party including, for the avoidance of doubt, distributors, resellers, agents or similar. The Customer acknowledges that it can solely rely on such representations with respect to the Device if provided by Cortrium.
  29. FORCE MAJEURE
  30. Cortrium shall not be held liable for any damage or losses sustained by the Customer as a direct or indirect consequence of Cortrium being delayed, prevented or hindered in the performance of its obligations under the Customer Agreement as a result of a force majeure situation. Force majeure situations include war and mobilization, computer viruses, hacking, catastrophes of nature, strikes, lock-out, fire, and damage to production plants, import and export regulations and other unforeseeable circumstances beyond the control of the Party concerned.
  31. BREACH
  32. In the event of a material breach of the Customer Agreement, Cortrium shall be entitled to terminate the Customer Agreement with immediate effect unless such material breach can be remedied within 5 days after the Customer has been notified hereof. For the avoidance of doubt, non-performance of payment obligations, application of the Reports or Device(s) contrary to the intended use or sub-letting the Report or Device or any part hereof to a third-party shall always constitute a material breach.
  33. If the Customer Agreement is terminated for breach and the Customer has subscribed for one or more Devices, the Customer must return any such Device(s) in accordance with clause 12.3. Further, Cortrium shall be entitled to claim damages in accordance with the general rules under Danish law.
  34. TERMINATION
  35. Each Party may terminate the Customer Agreement for convenience by providing 3 months’ written notice to the end of a month. Notwithstanding the foregoing, notice may at the earliest by provided 3 months after the Effective Date.
  36. If the Customer becomes subject to insolvency procedures, is declared bankrupt or is taken under reconstruction, Cortrium shall be entitled to terminate the Customer Agreement with immediate effect.
  37. Upon termination, provided one or more Device(s) are subscribed for, the Customer must, at its expense procure that the Device(s) is/are safely returned to Cortrium at its registered place of business, in Taastrup, Denmark, no later than 14 days after the date of termination. Failure to timely return the Device(s) shall entitle Cortrium to invoice the Customer for the Device(s) and the Customer shall be obligated to pay such invoice. Payment of the invoice shall not relief the Customer of the obligation to return the Device(s), which shall remain the exclusive property of Cortrium.
  38. MISCELLEANEOUS
  39. If any provision of the Customer Agreement is deemed entirely or partly invalid or unenforceable, then this shall not affect the general validity or enforceability of the other provisions or the Customer Agreement in its entirety. The invalid or unenforceable provision is deemed to be replaced by such valid and enforceable provision that reflects to the closest extent possible the intention that the Parties hereto had pursued with the invalid or unenforceable provision.
  40. Each Party shall treat as confidential and keep secret any knowledge, information or documentation on the Device and the other Party’s internal affairs, projects, products, financial status, business operations, customers etc., including information contained or embodied in the Device and the Customer Agreement. This obligation shall remain in force after termination of the contractual relationship for 3 years.
  41. Cortrium shall be entitled to state the Customer as a reference and to include the name of the Customer on its list of references.
  42. Cortrium reserves the right to transfer, fully or partially, rights and obligations relating to the Customer Agreement to a third-party.
  43. AMENDMENTS
  44. Any amendments to this Customer Agreement must be made in writing to be effective. Cortrium may amend the Customer Agreement including i.a. Fees from time to time always provided that the Customer is given notice of the amendment at least 3 months prior to the amendment taking effect.
  45. LAW AND VENUE
  46. The Customer Agreement shall be governed by the laws of the Kingdom of Denmark excluding (CISG). Any dispute arising out of or in connection with the Customer Agreement, which cannot be amicably settled between the Parties shall exclusively be brought before Danish courts.