General Terms and Conditions of Use for Patients

1. General

1.1 These General Terms and Conditions of Use for Patients (hereinafter “GTC”) govern the contractual relationship between Orbit Health GmbH, Mangfallstrasse 16, 82061 Neuried, Germany (hereinafter “Orbit”) and you as a patient and contractual partner of Orbit (hereinafter “Patient”) with regard to the use of the software application “Neptune”and the infrastructure provided thereby and the associated services (hereinafter collectively “Neptune Services”).

1.2 The version of the GTC valid at the time of conclusion of the contract between Orbit and the Patient shall apply.

2. Prescription of the Neptune Services, conclusion of Contract, access to GTC, contractual language

2.1 To use the Neptune Services, it is first necessary to download the software application “Neptune” from the app store and register in the software application. As part of the registration process, the Patient must create a patient account and the registration code must be entered into the app. Before completing the registration, the Patient will be asked to agree to these GTC, which will create the contract between the Patient and Orbit (hereinafter “Contract”).

2.2 The GTC can be accessed at any time by visiting this URL: https://orbit.health/neptune-for-patient-terms-agreement/

2.3 The contractual language is German  and English.

3. Requirement of a Smartwatch

3.1 For the Neptune Services to automatically monitor symptoms and provide treatment responses, it is required to use an appropriate smartwatch. If not available, the Patient must purchase the smartwatch separately directly from the manufacturer or a dealer. Orbit is not responsible for any defects of the smartwatch.

3.2 Smartwatches that are compatible with the Neptune Services are listed on the Orbit website. The smartwatch needs to be connected with the Neptune App on the Patient’s 

4. Delivery and service provision, deadlines

4.1 The conditions of delivery and service provision of the Neptune Services are determined by the Contract.

4.2 The service and delivery dates and deadlines stated by Orbit are only binding if this is contractually agreed. The aforementioned dates and deadlines will be extended – without prejudice to other statutory rights of Orbit – if and insofar as the Patient does not or insufficiently perform any acts of cooperation.

5. Remuneration, invoicing to statutory health insurance funds

If no payment by a statutory or private health insurance fund is applicable, Orbit will invoice the remuneration for the use of the Neptune Services directly to the Patient or the treating institution.  Unless otherwise agreed, the remuneration to be paid by the Patient or treating institution is due upon invoicing and is payable within fourteen (14) days from the invoice date without deduction. This does not apply to the usage of Neptune under a clinical trial setting.

6. Scope of services, availability, data transmission via the internet

6.1 The scope of services and the current functionalities of the Neptune Services are described by the descriptionavailable on the Orbit website at https://orbit.health/neptune at the time of the conclusion of the Contract. The use of the Neptune Services is limited to the territory of Germany  and Singapore.

6.2 THE NEPTUNE SERVICES ENABLE THE PATIENT TO DOCUMENT THE COURSE OF TREATMENT OF HIS/HER HEALTH COMPLAINTS BY MEANS OF A MODERN SYSTEM FOR SYMPTOM MONITORING. HOWEVER, THE NEPTUNE SERVICES DO NOT PROVIDE THE PATIENT WITH INDIVIDUAL DIAGNOSES FOR HEALTH COMPLAINTS OR THERAPY RECOMMENDATIONS. THIS IS ONLY POSSIBLE WITH THE INVOLVEMENT OF MEDICAL PROFESSIONALS (E.G. AN ESTABLISHED PHYSICIAN) WHO, FOR EXAMPLE, HAVE PRESCRIBED THE USE OF THE NEPTUNE SERVICES AND EVALUATE THE COURSE OF TREATMENT AS PART OF THE PATIENT’S MEDICAL TREATMENT.

6.3 The Neptune Services may be affected by interruptions, errors or delays. Such interruptions, errors or delays may be due to factors such as technical problems in the execution or operation of the software, infrastructure or servers of Orbit or third parties, or technical problems or high traffic on the internet or infrastructure failures.

6.4 Orbit will endeavor to keep the Neptune Services available at least ninety-nine (99) percent of the time on an annual average basis, not including downtime (a) during which the servers or functionality of the Neptune Services are unavailable due to technical or other problems beyond Orbit’s control (e.g., force majeure or fault of third parties); (b) used to improve the security and integrity of the servers or for maintenance work for the purpose of the proper operation or improvement of the Neptune Services.

6.5 Orbit uses appropriate security measures when transmitting Patient Data via the internet, such as encryption technologies that comply with statutory requirements. However, Orbit cannot fully guarantee or ensure data security when transmitting data via the internet. For this reason, any transmission of data via the internet within the framework of the use of the Neptune Services takes place at the Patient’s own risk.

7. Conditions of use, duties of cooperation and due diligence

7.1 The Patient is responsible for complying with the technical and system requirements for the use of the Neptune Services.

7.2 The Patient agrees (a) to use the Neptune Services (or any part thereof) solely in connection with his/her medically prescribed treatment (if any) and in accordance with the terms of these GTC; (b) not to take any action that may impair or interfere with the interoperability and functionality of the Neptune Services (or any part thereof); (c) not to violate any applicable law or third party rights in the use thereof; (d) not to introduce harmful code into the Neptune Services, such as viruses or other harmful computer programs that may, for example, damage or interfere with Orbit’s system, program, or data, or surreptitiously eavesdrop on or unauthorizedly spy on personal information (e) to cooperate in updating the Neptune Services, such as applying (security) patches, updates and upgrades via remote maintenance, and to perform all actions necessary for this purpose in order to maintain the interoperability and functionalities of the Neptune Services.

8. Orbit’s right to use Patient Data

The Patient grants Orbit a royalty-free, non-exclusive and Europe-wide  right of use to the usage data generated within the scope of the use of the Neptune Services, such as in particular the monitoring files generated by means of the symptom monitoring devices (hereinafter collectively “Patient Data”), to use the Patient Data (or in each case parts thereof) for purposes of (a) the provision and use of the Neptune Services during the term of the Contract, and to make them accessible to the treating physicians to whom the Patient grants access to the Patient Data within the scope of the prescription of the Neptune Services, as well as (b) the analyzation, evaluation and exploitation for the further development and improvement of the Neptune Services on a permanent basis in pseudonymized and anonymized form. Anonymized data may also be used in non-EU countries.

9. Patient’s right to use Neptune Services

9.1 To the extent necessary for the use of the Neptune Services, Orbit grants the Patient a non-exclusive, non-transferable right of use, limited in time to the term of the Contract, to use the Neptune Services in accordance with the agreed scope of services pursuant to section 6.1 and these GTC.

9.2 Unless expressly permitted by Sec. 69d and 69e of the German Copyright Act (“Urheberrechtsgesetz”) or these GTC, the Patient may not, without Orbit’s prior written consent (a) edit, redesign, adapt, translate, reproduce, publish, decompile, disassemble or reverse engineer (so-called reverse engineering) the Neptune Services (or any part thereof); (b) circumvent any technical limitations; or (c) use the Neptune Services for commercial purposes.

10. Data protection

10.1 Orbit processes personal data collected in the course of using the Neptune Services exclusively in compliance with the applicable data protection laws, in particular the EU General Data Protection Regulation and the German Federal Data Protection Act (“Bundesdatenschutzgesetz”). Further information on the processing of personal data can be found in the Privacy Policy for the use of Neptune Services, which is not part of these GTC, but serves exclusively as information according to Art. 13 GDPR.

10.2 THE USE OF THE NEPTUNE SERVICES REQUIRES THE PATIENT’S CONSENT TO THE PROCESSING OF HIS/HER PATIENT DATA IN ACCORDANCE WITH DATA PROTECTION LAW. IF THE PATIENT DOES NOT CONSENT TO THIS DATA PROCESSING, HE/SHE CANNOT USE THE NEPTUNE SERVICES.

The Patient undertakes towards Orbit to comply with the data protection laws applicable in connection with the use of the Neptune Services, in particular the EU General Data Protection Regulation and the German Federal Data Protection Act (“Bundesdatenschutzgesetz”).

11. Claim for defects

11.1 The liability for defects is governed by the statutory law as modified by the following provisions.

11.2 The Patient shall report any defects of the Neptune Services to Orbit without undue delay in text form or by telephone, stating the exact nature of the defect, its effect and the circumstances under which it occurs. The current contact details can be found on the Orbit website at https://orbit.health.

11.3 Orbit is entitled to bypass a defect if the defect itself can only be rectified by disproportionate effort and the bypass solution only insignificantly affects the interoperability and functionalities of the Neptune Services.

11.4 Orbit is not liable for defects that (a) are caused by software components or services of third parties that are not provided by Orbit or (b) are based on an unauthorized use of the Neptune Services (including access to them) in accordance with these GTC.

11.5 Orbit is liable for damages for defects only according to the provisions of section

11.6 The provisions of this section 11 are without prejudice to claims for defects which Orbit has fraudulently concealed or which are covered by a guarantee of quality or durability.

12. Liability

12.1 Any strict liability for damages for defects existing at the time of the conclusion of the Contract is excluded

12.2 Orbit shall be unrestrictedly liable for any damage caused by intent or gross negligence. In the event of a slightly negligent breach of an obligation whose breach puts the achievement of the contractual purpose at risk or whose fulfilment is essential to the due and proper implementation of the Contract and on whose fulfilment the Patient could reasonably rely on (hereinafter “Essential Accessory Obligation”), the liability of Orbit is limited to damage foreseeable at the time of conclusion of the Contract and characteristic for the Contract.

12.3 Orbit accepts no liability for slightly negligent breaches of obligations which are not Essential Accessory Obligation.

12.4 The above exclusions and limitations of liability shall not apply in the event of fraudulently concealment of defects or a guarantee as to quality or durability, to the liability for claims under the German Product Liability Act (“Produkthaftungsgesetz”) and to claims based on slightly negligently caused personal injuries (life, limb or health). This shall not entail a reversal of the burden of proof to Patient’s disadvantage.

12.5 Where the liability of Orbit is excluded or limited, this also applies to the personal liability of Orbit’s employees, members of staff, representatives and vicarious agents.

12.6 With the exception of claims based on tortious acts, claims for damages, for which Orbit’s liability is limited under this section 12, become time-barred within one (1) year, calculated from the beginning of the statutory limitation period. This shall not entail a reversal of the burden of proof to Patient’s disadvantage.

13. Term, termination, consequences of termination

13.1 The term of the Contract commences upon conclusion of the Contract and, unless otherwise agreed, runs for the duration of the prescription by the treating physician or the statutory health insurance fund.

13.2 The Contract has a fixed term for the duration of the prescription. The right to extraordinary termination for good cause remains unaffected. The termination must be in textform.

13.3 Upon termination of the Contract, the Patient is no longer entitled to use the Neptune Services.

13.4 Within one (1) month after termination (post-storage period), Orbit will provide the Patient upon request with the Patient Data stored in the Neptune Services at that time in a common data format. After the expiration of the post-storage period, Orbit is entitled to irreversibly delete the Patient Data stored in the Neptune Services and to deactivate the patient account of the Patient.

14. Withdrawal Policy

The withdrawal right applies solely to a Patient that is a natural person who concludes the legal transaction for a purpose that can predominantly be attributed neither to his commercial nor to his independent professional activity (consumer).

14.1 Withdrawal Right

You may revoke your contract within 14 days without having to state reasons. The withdrawal period shall be fourteen days from the date of the conclusion of the contract. To exercise your right of withdrawal, you must inform Orbit Health GmbH, Mangfallstrasse 16, 82061 Neuried of your decision to withdraw from this contract by means of a clear declaration (e.g. a letter sent by post, or e-mail at neptune@orbit.health). You can use the model withdrawal form below for this purpose, which is, however, not mandatory.

In order to comply with the withdrawal period, it is sufficient that you send the notification of the exercise of the right of withdrawal before the expiry of the withdrawal period.

14.2 Consequences of withdrawal

If you withdraw from this contract, we must refund all payments we have received from you, including delivery costs (with the exception of additional costs resulting from the fact that you have chosen a type of delivery other than the cheapest standard delivery offered by us), without delay and at the latest within fourteen days of the day on which we received notification of your withdrawal from this contract. For this repayment, we will use the same means of payment that you used for the original transaction, unless expressly agreed otherwise with you; in no case will you be charged for this repayment.

15. Withdrawal Template

(If you wish to cancel the contract, please complete and return this form).

To

Orbit Health GmbH

Mangfallstrasse 16

82061 Neuried

E-mail: Neptune@orbit.health

I/we (*) hereby revoke the contract concluded by me/us (*) for the purchase of the following goods (*) /the provision of the following service (*)

Ordered on (*):                                             Received on (*):

Name of consumer(s):

Address of consumer(s):

Date:

(*) Delete where inapplicable

 

16. Applicable law, Alternative Dispute Resolution in Consumer Matters, Severability

16.1 The legal relationships arising from or in connection with the Contract shall be governed by German law. If you are a consumer domiciled outside the Federal Republic of Germany but within the EEA, the law of the country in which you are domiciled may also apply if it is a matter of mandatory provisions.

16.2 The European Commission provides a platform for extrajudicial online dispute resolution (ODR platform), which can be accessed at https://ec.europa.eu/consumers/odr. Orbit does not participate in dispute resolution procedure before a consumer conciliation body and is not obliged to do so.

16.3 Should individual provisions of the Contract with the Patient or of these GTC be or become invalid, the remaining provisions shall remain unaffected.

16.4 These GENERAL TERMS AND CONDITIONS have been prepared in an English original and a German translation. In case of any discrepancies between the two versions, the English version shall prevail.

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