Home Vision Monitor App End User Licence Agreement

This Home Vision Monitor App End User Licence Agreement (“Agreement”) is made between the Patient (“Patient”) who has been offered the use of the Home Vision Monitor app (“App”) by a licensed physician or optometrist (“Practice”) and Roche Products Limited, a company registered in England and Wales (company number 00100674) with its registered office at 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW (“Roche”).

This Agreement sets out the licence terms for the App and related documentation, and describes the services that Roche will provide in connection with the App. 

The Patient must be 18 or over to accept the terms in this Agreement and download the App.

Questions related to this Agreement may be directed to Roche via phone on 0800 7315 711 (Option 4) from 8:30am-5:00pm (GMT), Monday to Friday.

The App can be found in the app stores (Apple App Store or GooglePlay). The terms of the relevant platform providers (over which Roche has no influence) apply there; these are not part of the terms of this Agreement nor Roche’s contractual relationship with the Patient as the user of the App. The devices and operating systems that are compatible with the App can be found in the app stores (Apple App Store or GooglePlay).

1. CE MARKING INDICATION FOR USE

Patient acknowledges that the App is CE marked and authorised for use as follows: 

The App is intended for the detection and characterisation of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia.  The App is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The App is not intended to diagnose; diagnosis is the responsibility of the Practice. 

The App has been cleared for use for monitoring eyes that do not have any other existing pathology which could compromise vision test data.

The App cannot replace consultation with and diagnosis by a healthcare professional.

2. PRIVACY POLICY

Roche shall maintain personal information about the Patient on behalf of the Practice, including registration information and automatically collected information in accordance with applicable data protection legislation. The privacy policy for the App may be found within the App.

3. SERVICES

The services in relation to the App provided by Roche to the Patient shall include: (a) electronic transmission of vision test data from Patient’s device to the database located on Roche’s secured server; (b) maintenance, during the time that the Patient is an active user of the App and such additional period thereafter as required by law, of a proprietary database on which Patient’s data is electronically catalogued and stored; (c) technical support (which shall include, without limitation, troubleshooting and device use assistance) via phone on 0800 7315 711 (Option 4) from 8:30am-5:00pm (GMT), Monday to Friday; and (d) provision to the Practice of access to Patient’s vision test results stored on a secured server hosted by a third party. In addition to these services, (e) Roche will inform the Practice via email of a statistically significant change in the Patient’s vision test scores. Together, these services shall be the “Services”.

4. UPDATES TO THE APP AND CHANGES TO THE SERVICES

From time to time, Roche may automatically update the App and change the Services to improve performance, enhance functionality, reflect changes to the operating system or address security issues. Alternatively Roche may ask the Patient to update the App for these reasons.

If the Patient chooses not to install such updates or if the Patient opt out of automatic updates the Patient may not be able to continue using the App and the Services.

5. LICENCE

Roche is licensed to use all intellectual property in the content of the App and reserves the right to pursue any intellectual property infringement in the courts of the country where it suffers damage. No licence is granted in this Agreement to use any trade name or mark of Roche or their affiliated companies.

Roche grants a licence to use the software embedded in the App (“Roche Software”) and the related documentation to support the Patient’s permitted use of the Roche Software in accordance with this Agreement. Patient acknowledges that all Roche Software is proprietary to Genentech, Inc (“Genentech”), title shall at all times be vested in Genentech, and except as provided herein, no right, title or interest therein shall pass to Patient. 

1. Licence Restrictions

The Patient agrees:

1. that it shall not rent, lease, sub-licence, loan, provide, or otherwise make available, the Roche Software in any form, in whole or in part to any person; 
2. not copy the Roche Software, except as part of the normal use of the App or where it is necessary for the purpose of back-up or operational security; 
3. not to translate, merge, adapt, vary, alter or modify, the whole or any part of the Roche Software nor permit the Roche Software to be combined with, or become incorporated in, any other programs, except as necessary to use the App on devices as permitted in these terms; and 
4. not to disassemble, de-compile, reverse engineer or create derivative works based on the whole or any part of the Roche Software nor attempt to do any such things, except to the extent that (by virtue of sections 50B and 296A of the Copyright, Designs and Patents Act 1988) such actions cannot be prohibited because they are necessary to decompile the Roche Software to obtain the information necessary to create an independent program that can be operated with the Roche Software or with another program (“Permitted Objective”), and provided that the information obtained by the Patient during such activities:

• is not disclosed or communicated without Roche’s prior written consent to any third party to whom it is not necessary to disclose or communicate it in order to achieve the Permitted Objective; and
• is not used to create any software that is substantially similar in its expression to the Roche Software;
• is kept secure; and
• is used only for the Permitted Objective.

1. Acceptable Use Restrictions

The Patient must:

• not use the Roche Software in any unlawful manner, for any unlawful purpose, or in any manner inconsistent with these terms, or act fraudulently or maliciously, for example, by hacking into or inserting malicious code, such as viruses, or harmful data, into the Roche Software or any operating system;
• not infringe Roche’s intellectual property rights or those of any third party in relation to the Patient’s use of the Roche Software, including by the submission of any material (to the extent that such use is not licensed by this Agreement);
• not transmit any material that is defamatory, offensive or otherwise objectionable in relation to the Patient’s use of the Roche Software; or
• not use the Roche Software in a way that could damage, disable, overburden, impair or compromise Roche’s systems or security or interfere with other users.

6. NOTIFICATION UNDERTAKING

During the period that the Patient is using the App the Patient shall promptly notify the Practice when Patient becomes aware of or reasonably should have become aware of: (a) any change or deterioration in Patient’s eye condition; (b) any amendment to the prescription for monitoring one eye instead of two eyes; (c) any other change or deterioration in Patient’s health that could reasonably restrict Patient’s use of the App; (e) the termination of her/his relationship with the Practice. 

7. DISCLAIMER OF WARRANTY

EXCEPT AS EXPRESSLY SET FORTH HEREIN AND EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, ROCHE DISCLAIMS ALL WARRANTIES WHETHER WRITTEN, ORAL OR STATUTORY, APPLICABLE OR RELATING TO THE APP, SERVICES, AND RELATED TECHNICAL OR OTHER ADVICE OR REPRESENTATIONS. EXCEPT AS SPECIFICALLY PROVIDED HEREIN, THE SERVICES (INCLUDING THE ROCHE DATABASE AND THE ABILITY TO TRANSMIT, STORE, AND ACCESS VISION TEST RESULTS) ARE PROVIDED “AS IS” AND “AS AVAILABLE,” WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED. TRANSMISSION OF VISION TEST RESULTS MAY VARY BASED UPON THE EQUIPMENT AND SERVICE PROVIDER USED. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, ROCHE DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF PERFORMANCE, SERVICE, ACCURACY, OMISSIONS, COMPLETENESS, CURRENTNESS AND DELAYS. ROCHE DOES NOT WARRANT THAT ABILITY TO TRANSMIT VISION TEST RESULTS OR ANY ACCESS TO THE ROCHE DATABASE WILL BE UNINTERRUPTED, SECURE, COMPLETE OR ERROR FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THE SERVER(S) THAT MAKE THE SERVICES AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. 

PATIENT ACKNOWLEDGES THAT USE OF THE APP AND RELATED SERVICES ARE NOT ERROR-FREE, AND THAT PATIENT MAY ENCOUNTER HUMAN AND MACHINE ERRORS, DELAYS, INTERRUPTIONS AND LOSSES, INCLUDING THE INADVERTENT LOSS OF VISION TEST RESULTS. EXCEPT WHERE AND TO THE EXTENT THAT ROCHE EXPRESSLY ACCEPTS LIABILITY UNDER CLAUSE 8 OR IS LIABLE BY LAW UNDER PRODUCT SAFETY LEGISLATION, THE PATIENT RELEASES, FOREVER DISCHARGES AND HOLDS ROCHE HARMLESS FROM AND AGAINST ANY DAMAGES, LIABILITIES, COSTS OR EXPENSES, INCLUDING, WITHOUT LIMITATION, LOSS TO OR CORRUPTION OF VISION TEST RESULTS, OR LOSS OR DAMAGE TO ANY OTHER PROPERTY OF PATIENT THAT ARISES IN WHOLE OR IN PART FROM PATIENT’S USE OF THE APP AND SERVICES.

8. LIMITATION OF LIABILITY

If Roche fails to comply with the terms in this Agreement, Roche is responsible for loss or damage that the Patient suffers that is a foreseeable result of Roche breaking these terms or Roche failing to use reasonable care and skill, but Roche is not responsible for any loss or damage that is not foreseeable. Loss or damage is foreseeable if either it is obvious that it will happen or if, at the time that the Patient accepted these terms in this Agreement, both Roche and the Patient knew it might happen. 

Roche does not exclude or limit in any way Roche’s liability to the Patient where it would be unlawful to do so. This includes liability for death or personal injury caused by Roche’s negligence or the negligence of Roche’s employees, agents or subcontractors or for fraud or fraudulent misrepresentation.

If defective digital content that Roche has supplied damages a device or digital content belonging to the Patient, Roche will at its own option either repair the damage or pay the Patient compensation. However, Roche will not be liable for damage that the Patient could have avoided by following Roche’s advice to apply an update offered to Roche free of charge or for damage that was caused by the Patient failing to correctly follow installation instructions or to have in place the minimum system requirements advised by Roche.

The App is intended for the use set out in Clause 1. If the Patient uses the App for any commercial, business or resale purpose, Roche will have no liability to the Patient for any loss of profit, loss of business, business interruption, or loss of business opportunity. 

Roche recommends that the Patient backs up any content and data used in connection with the App, to protect itself in case of problems with the App or the Services.

If Roche’s provision of the App or the Services is delayed by an event outside Roche’s control then Roche will take reasonable steps to minimise the effect of the delay. Provided that Roche does this, Roche will not be liable for delays caused by the event but if there is a risk of substantial delay the Patient may contact Roche to end this Agreement.

9. NOTICES

Unless specifically provided otherwise, all notices hereunder will be in writing and shall be given by and be deemed received by the receiving party (i) if sent by a delivery service, on the date confirmed as the actual date of delivery by such service; (ii) if sent by registered mail within five (5) days of mailing; or (iii) if sent by e-mail or fax with an electronic written confirmation of receipt, on the next business day after transmission, if not transmitted on a business day, or on the day of transmission, if transmitted on a business day.

10. TERMINATION

The Agreement is effective until terminated by the Patient or Roche. The Patient’s rights under this Agreement will terminate automatically without notice from Roche if the Patient fails to comply with any term(s) of this Agreement or if Practice notifies Roche that the Patient ceases to be a patient of the Practice. Upon termination of the Agreement, the Patient shall cease all use of the Roche Software, and destroy all copies, full or partial, of the Roche Software.

11. REPORTING

If in the course of the activity covered by this Agreement, the Patient becomes aware of suspected adverse events (including a potential side effect), special situation reports* and/or product complaints associated with the use of a Roche product, this should be reported:

1. to Roche within one (1) business day by phone on 0800 7315 711 (Option 4) from 8:30am - 5:00pm (GMT) Monday to Friday; or
2. to the Patient’s health care professional at the Practice; or
3. electronically via the Yellow Card website (https://yellowcard.mhra.gov.uk/).

 * Special situation reports may include Pregnancy/Breastfeeding, use in Pediatric/Elderly population, Lack of Efficacy, Overdose, Misuse, Abuse, Off Label Use, Medication Error (including Intercepted Medication Error and Potential Medication Error), Occupational Exposure, data related to a Suspected Transmission of an Infectious Agent via a Medicinal Product (STIAMP), Drug Interaction, Falsified Medicinal Products (whether suspected or confirmed) and suspected adverse events from class action lawsuits.

12. GENERAL

Roche may transfer its rights and obligations under this Agreement to another organisation. The Patient may not transfer its rights or its obligations under this Agreement.

This Agreement does not give rise to any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement.

Each of the paragraphs of this Agreement operates separately. If any court or relevant authority decides that any of them are unlawful, the remaining paragraphs will remain in full force and effect.

Even if Roche delays in enforcing this contract, Roche can still enforce it later. If Roche does not insist immediately that the Patient do anything the Patient is required to do under this Agreement, or if Roche delay in taking steps against the Patient in respect of the Patient breaking this Agreement, that will not mean that the Patient does not have to do those things and it will not prevent Roche taking steps against the Patient at a later date.

Except as prohibited by applicable law, no action, regardless of form, arising out of the Agreement may be brought by Patient more than two (2) years after the cause of action has arisen. 

The obligations of Patient under the Agreement shall survive the termination of the Agreement to the extent required for their full observance and performance. The captions in the Agreement are for convenience only and shall not define or limit any of the terms hereof. The Agreement shall be      governed and construes in accordance with the laws of  England and Wales and the courts of England and Wales shall have exclusive jurisdiction to hear any dispute relating to this Agreement.