Terms & conditions

TERMS AND CONDITIONS - UNITED KINGDOM - for CRUSE APP (Chronic Urticaria Self Evaluation APP)

Version: 25. February 2022, last updated: 25. February 2022)

As a user of the CRUSE APP, we ask you to note the following Terms and Conditions. The minimum age to use our services is 18 years.

The terms and conditions (hereinafter „T&C“) apply regardless of the systems, platforms and devices used (e.g. iOS or Android) on which the app is running. These T&C apply for users from the United Kingdom (e.g. England, Wales, Scotland and Northern Ireland, hereinafter also named “UK”). The T&C will be governed by and construed under the laws of England and Wales.

The following T&C are categorized in: 1. Scope and Partner of this Contract 2. Range of Services and Important Information 3. Conclusion of Contract and Registration 4. Costs 5. Features and Availability 6. Scope of the Rights of Use 7. User Obligations 8. Handling of User Data 9. Use of Collected Data for Research Purposes 10. Disclaimer of Warranty and Limitation of Liability 11. Termination 12. Future Adjustments of the T&C 13. Final Provisions

1. Scope and Partner of this Contract The services of the Chronic Urticaria Self Evaluation APP (hereinafter „CRUSE APP“) and their use are offered exclusively on the basis of the following T&C. The use of the CRUSE APP is only permitted after agreeing to the applicable T&C, data protection guidelines and cookie guidelines. The imprint is available under <...> (Anm. RAin: bitte direkt den Link zu dem konkreten Inhalt einsetzen). The CRUSE APP is available as mobile app for iOS and Android. The GA²LEN e.V., c/o DGAKI, Robert-Koch-Platz 7, 10115 Berlin, Germany (hereinafter „GA²LEN e.V.“) makes the app available for patients (hereinafter „users“) to download and use free of charge. If the user uses their own T&C, the GA²LEN e.V. won‘t recognize them – except for cases of expressly written consent. Only natural persons are permitted to use the CRUSE APP. The use of the CRUSE APP for purposes that can be attributed to self-employed professional activity or for other commercial purposes is not permitted unless GA²LEN e.V. has permitted this based on a separate written agreement in individual cases. These T&C are used by GA²LEN e.V. represented by Mr. Reinhardt Britz c/o DGAKI Robert-Koch-Platz 7 10115 Berlin Any statements and declarations regarding this contract as well as questions or requests in connection with the use of the CRUSE APP can be addressed by users at any time to: cruse@ga2len.berlin

2. Range of Services and Important Information 2.1. Subject of the CRUSE APP The CRUSE APP helps patients with chronic urticaria (nettle rash) to identify and document the causes and course of the disease and to analyse the progression of the disease with the treating doctor. The overviews created based on the user data can be used by a doctor to review and adjust the ongoing therapy and thus contribute to improving the quality of life of the users overall. In addition to triggers and the current medication, images of the symptoms (redness, wheals, swelling) can also be uploaded to document the course of the disease. Overall, this supports the therapeutic assessment of the doctor. Please note, that GA²LEN e.V. is not able to access other medical data or medical records that the user may have stored with a different digital service or within the GP records. The CRUSE APP is not meant to be a medical archive. GA²LEN e.V. can’t add to or modify the medical records of the user. 2.2. Important Information on therapy-accompanying Use The user of the CRUSE APP is aware that the information provided by the CRUSE APP does not surrogate a diagnosis, advice or recommendation by a doctor. The data and information provided as part of the CRUSE APP are not allowed to be used for the unauthorized adjustment or suspension of the ongoing treatment and cannot anticipate or replace a medical check and therapy decision. The user is also aware that the data displayed depends significantly on the quality and frequency of his data entry. The use of the CRUSE APP as a therapy-accompanying aid is dependent on the completeness, correctness and regularity of the data entry. Questions about medical conditions should always be clarified with the treating physician or an otherwise qualified healthcare professional. The information taken from the CRUSE APP should never be used as a reason to disregard the qualified advice of a doctor, to postpone an appointment or to not seek medical help. In urgent cases, a doctor or, if necessary, an emergency room should be seeked out. The information provided as part of the CRUSE APP does not claim to be complete. The use of the CRUSE APP and its functions is carried out by the user at his own risk and exclusively as a tool within the framework of self-responsible implementation. 2.3. Updating the Version of the CRUSE APP The content and functions presented in the CRUSE APP are subject to constant further development due to ongoing medical research. In addition, technical adjustments to the app may become necessary. GA²LEN e.V. reserves the right to implement any adjustments by providing updates. Correspondingly, the user undertakes to only use the most current version of the CRUSE APP. The version that is freely accessible to the user and can be viewed via the App Store or Google Play is decisive. The user is acting unlawfully if he continues to use the old app version without authorization even though the CRUSE APP has been updated to a new version. If he uses an old version in violation of the contract, he does so at his own risk and responsibility.

3. Conclusion of Contract and Registration 3.1. Conclusion of the Contract The contract is concluded when the service provided by GA²LEN e.V. is used by downloading the application onto a mobile device, but no later than when you register your own user account. The T&C valid at the time the contract is concluded apply. In addition, the applicable terms and conditions of the Apple Store or Google Play apply according to the operating system of the end device used. GA²LEN e.V. is not responsible for the content of the terms and conditions of any third-party service providers used to use the CRUSE APP and assumes no liability in this respect. 3.2. No Obligation to Conclude a Contract There is no legal right to use the services of GA²LEN e.V. GA²LEN e.V. reserves the right to refuse registration without giving reasons. 3.3. User Account The CRUSE APP can also be used without setting up a user account. However, registering a user account is recommended. If a user account is not set up as part of the registration, the use of the CRUSE APP is limited to the end device with which the application was downloaded and which was initially used for data entry. In the event of damage or loss of the end device, the course of the disease that has already been documented with the CRUSE APP cannot be restored. The same applies if the CRUSE APP is uninstalled. An e-mail address and a password are required for registration. The user will be sent a confirmation link to the email address provided. After setting up the user account, the data entered by the user is stored on the servers of GA²LEN e.V. This enables password-protected access by the user to his data from other end devices or after the CRUSE APP has been uninstalled beforehand. When registering, the user's data must be truthful. The user reports relevant change to his personal data immediately and has to update the stored user data accordingly.

4. Costs Downloading and using the CRUSE APP is free of charge for the user. Any arising expenses while using the app, e.g. connection charges of a mobile phone or internet provider, are to be borne by the user and are not the subject of this agreement.

5. Features and Availability 5.1. Features of the CRUSE APP The CRUSE APP enables the diary documentation of the individual course of the disease. By answering a given catalogue of questions, the therapy-relevant scores (AUS/AAS, UCT/AECT) can be calculated as a value, as well as displayed graphically and compared and evaluated over time. In addition, a photographic documentation of the symptoms can be created and saved locally by the user. If desired, automatic notifications can be created that regularly remind the user to enter the diary documentation and motivate them to document the symptoms continuously and coherently. Reminders will be sent via push notifications. Using the CRUSE APP, the data on the current course of the disease can be generated in a separate overview as a PDF document. Users can provide their doctor with said overview of their scores and medication for further treatment. Registered users are given the opportunity to dispatch the data collected by the CRUSE APP to their verified e-mail. The responsibility for which data is released by the user to third parties lies solely with the user of the CRUSE APP. The GA²LEN e.V. does not assume any responsibility or liability for damage caused by the release of data though the user. 5.2. Future Feature Changes GA²LEN e.V. reserves the right to change the functions offered by the CRUSE APP through updates. The changes contained in the update are announced to the user via www.crusecontrol.com. The updates are also made available in the Apple App Store or Google Play. 5.3. Availability of the CRUSE APP The range of services offered by GA²LEN e.V. for using the CRUSE APP by setting up a user account is limited to its actual availability. Otherwise, a right to use the CRUSE APP only exists within the limits of the current state of the art. The GA²LEN e.V. strives for a continuous provision of the services necessary for the use of the CRUSE APP (e.g. storage and synchronization of user data), but assumes no guarantee or liability for the uninterrupted usability of the offer. Unrestricted availability cannot be technically guaranteed, since use requires access to an internet- and possibly network connection, which GA²LEN e.V. cannot influence. The user cannot derive any claims from technically caused delays, interruptions and short-term failures. Insofar as this is necessary for maintenance, program maintenance or data backup work, GA²LEN e.V. can also temporarily restrict the functions of the CRUSE APP. In the event of downtime for scheduled maintenance work, the interests of the users are protected by prior notification. If there are indications that the CRUSE APP is not working as intended and that the malfunction could affect the legal interests of the users, GA²LEN e.V. is entitled to switch off individual functions of the CRUSE APP temporarily or completely. GA²LEN e.V. does not pay any compensation if individual functions are switched off in the interest and to protect the users. 5.4. Availability of Stored Data and Limits of Recovery Subject to the obligations set out in the privacy statement, GA²LEN e.V. is generally not obliged to store the health data entered by the user or to secure it for a specific period of time. The CRUSE APP does not serve as a medical archiving system, so that the permanent backup of the data stored in the user account is the sole responsibility of the user. He is therefore required to permanently save the health data that is important to him outside of the CRUSE APP (backup). If the registered user uninstalls the CRUSE APP on a mobile device and can therefore no longer access his data, the data stored in the user account can regularly be made accessible again when the app is reinstalled on the same or another device. The GA²LEN e.V. - without prejudice to the mandatory provisions of the privacy statement - does not guarantee that the data transmitted after registering a user account cannot be lost. The recovery of lost data is not the subject of this agreement, regardless of whether the data loss is due to a technical error in the end device, the CRUSE APP, an independent (also unintentional) deletion by the user or for other reasons. If the CRUSE APP is used without a registered user account, there is neither the technical possibility nor a legal obligation for GA²LEN e.V. to restore the deleted data. The data security of the app stores can not be guaranteed. The GA²LEN e.V. also assumes no liability for the risk of data loss during transmission over the Internet. 5.5. Related Third Party Services The service content of the CRUSE APP may depend on an active internet connection of the mobile device used. Registered users also need an e-mail account. It is pointed out that the technical infrastructure of the user, namely the use of suitable hardware, the provision and leasing of internet access and any data volume required, are not part of the range of services offered by GA²LEN e.V. The user is responsible for providing the equipment and services that he needs to access and use the CRUSE APP.

6. Scope of the Rights of Use The user has a limited, non-exclusive and revocable right to use the CRUSE APP in accordance with these T&C as long as the contractual relationship has not been terminated. A transfer beyond the mere use of rights does not take place. The content, information, images, logos, videos, documents, source code, databases and other trademark, identification, domain and patent rights made accessible via the CRUSE APP and website are protected by copyright and are regularly owned by GA²LEN e.V. or third parties or are licensed by them. The user may only use this protected content for the contractually permitted purposes, i.e. for private, non-commercial use. Reproduction, distribution or other unauthorised disclosure and use of the content and the code of the CRUSE APP is prohibited and can only take place after obtaining the express written consent of GA²LEN e.V. #

7. User Obligations The user must provide the necessary hardware to use the CRUSE APP and is obliged to independently check the compatibility of the CRUSE APP with the operating system used. The technical requirements can be viewed in the respective app store. The user is also responsible for using (and updating) his own virus protection software on his end device. When using a registered account, the user is obliged to keep his login details secret. If the user loses his password or the end device on which the CRUSE APP was installed without further backup/protection or if there is a suspicion of misuse of the user account, GA²LEN e.V. must be informed immediately. The user is obliged not to block, overwrite or modify any content generated by the CRUSE APP or to interfere with the app in any other way. The user is responsible for the completeness and correctness of all input data, including information on the state of his health when answering medical questions. He is also aware that the success of using the CRUSE APP depends on the correctness, regularity and completeness of the entries. There is no obligation for GA²LEN e.V. to verify the entries. If the data entered is incorrect, incomplete and/or not updated, the user must expect that the results obtained may be inaccurate.

8. Handling of User Data The collection, processing, use, transfer and storage of the data entered when using the CRUSE APP is based on the applicable privacy statement, available at <…>. The personal data provided by the user will only be processed with the provision of the CRUSE APP range of services. (Anm. RAin: bitte direkt den Link zu dem konkreten Inhalt einsetzen).

9. Use of the Collected Data for Research Purposes GA²LEN e.V. does not forward personal data to third parties without the consent of the user. The data collected may be made available to third parties in an anonymous form for research purposes if the user agrees to the terms of the data protection declaration. The data is considered as anonymized if it can no longer be assigned to a specific person.

10. Disclaimer of Warranty and Limitation of Liability 10.1. Disclaimer of Warranty GA²LEN e.V. does not make any warranty, express or implied, as to accuracy, reliability or availability of the CRUSE APP. GA²LEN e.V. provides its services as described. Unless separately agreed in writing the description is not to be deemed as guaranteed. 10.2. General Limited Liability These T&C do not exclude or limit the liability of GA²LEN e.V. when it would be unlawful to do so under the law of England and Wales. GA²LEN e.V. will not be liable for damages suffered through actions of a third parties (for instance, for independent decision of your treating doctor as described under 10.4, or failing or malfunctioning service of other service providers). The same applies for any losses or damages the user suffers from using services or websites the CRUSE APP may link to. It is the sole responsibility to check if he wants to use other services and if he wants to accept the terms and conditions of these third-party services and websites. Neither GA²LEN e.V. nor the user shall be liable for a breach of these T&C caused by circumstances beyond their reasonable control. In such case the affected party is obliged to notify the other immediately. This doesn’t apply to requirements to comply with applicable law or anything caused by wilful act or negligence. Provided GA²LEN e.V. is liable for damages caused by the CRUSE APP, the liability shall be limited as follows: • In the event of breaches of contract caused by simple negligence the liability is limited to the typical average direct damages that were foreseeable when concluding the contract. A loss or damage is either foreseeable if it is obvious that it will happen or if at the time the user accepted these T&C, both parties knew it might happen. • GA²LEN e.V. does not assume any liability for breaches of non-essential contractual obligations (e.g. such obligations, that are not required to perform the service or this agreement) arising from simple negligence. • GA²LEN e.V. does not assume liability for losses or damages caused by the users own breach of these T&C. Since the CRUSE APP is only supplied for domestic and private use, GA²LEN e.V. has no liability for any loss of business, business opportunity or profit or any interruption of business. These limitations of liability do not affect any claims the user raises under the product liability law or a separate guarantee. The liability of GA²LEN e.V. will also not be limited or excluded for • negligently caused death or personal injury, • for fraud or fraudulent misrepresentation, • gross negligence and intentionally caused damages • or, if the user can show, that GA²LEN e.V. failed to use reasonable skill and care to prevent a loss or damage the user’s device or digital content suffered due to the use of the CRUSE APP. 10.3. Dealing with Deleted Data There is no entitlement to the recovery of deleted data, since recovery is regularly technically impossible for GA²LEN e.V. In the event of any other loss of data, liability is limited to the effort required to restore the lost data with reasonable effort using the data backups properly carried out by the user. 10.4. Medical Self-Responsibility The GA²LEN e.V. assumes no liability or responsibility for medical diagnoses, recommendations and therapies, since the CRUSE APP does not provide clinical diagnosis or medical advice. It is solely the responsibility of the user and the treating doctor whether and to what extent the content provided by the CRUSE APP is taken into account. The GA²LEN e.V. also assumes no liability or guarantee that the ongoing treatment will be successful. The in section 2.2. contained information is expressly pointed out again. The GA²LEN e.V. is also not liable for the fact that the benefit of the CRUSE APP is restricted or lost altogether because the user has entered insufficient data or incorrect data contrary to the contract. 10.5. Use of an Unsuitable Operating System GA²LEN e.V. is not liable for damage resulting from the use of the CRUSE APP with a version of the operating system, browser or corresponding programs that are not or no longer supported, or from using a manipulated end device (in the sense of unauthorized intervention in the program code of the end device). The user must bear all consequences, disadvantages or damage resulting from this. 10.6. Using an old App Version If a version update of the CRSUE APP is made available, the unauthorized continued use of the old app version is contrary to this contract and deemed illegal. It takes place at the user's own responsibility and risk and releases the GA²LEN e.V. from liability from the old version. 10.7. Extension of Liability Limitations/Exclusions The above exclusions and limitations of liability apply to the same extent in favour of the organs, legal representatives, employees or other vicarious agents of GA²LEN e.V.

11. Cancellation The unregistered user can cancel this contract at any time by uninstalling the CRUSE APP. In addition, both parties can terminate the contract with a notice period of four weeks. The user can give notice of termination in text to GA²LEN e.V. (e-mail is sufficient). Under the applicable law, each party reserves the right to terminate without notice. In particular, GA²LEN e.V. reserves the right to terminate without notice if there is suspicion of misuse (e.g. false or incomplete user account, commercial use for third parties) or a significant breach of contract (e.g. manipulation of the CRUSE APP, unauthorized duplication of the app content) and to block the user's access if there is reasonable suspicion. If the suspicion can be dispelled, the blocking can be lifted. After the termination of the contract, the CRUSE APP may no longer be used.

12. Future Adjustments of the T&C The current T&C can always be viewed both in the app and on the website under <…>. (Anm. RAin: bitte direkt den Link zu dem konkreten Inhalt einsetzen). GA²LEN e.V. reserves the right to change the T&C with effect for the future if this should become necessary to implement changed legal requirements or supreme court decisions, due to changes in legal and egonimic circumstances of GA²LEN e.V. or due to technical further development of the app. GA²LEN e.V. will notify the user of any intended change in advance in a suitable manner with a period of at least four weeks before the planned effective date. If the user does not object to the amended T&C within this period, these apply to the further contractual relationship from the expiry of the period. The user will be informed separately of the deadline and the associated effect in the notification about the changed T&C. The objection must be made in writing (e-mail is sufficient). The dispatch of the objection is decisive for compliance with the deadline. If the user objects to the change of the T&C, the previous T&C will continue to apply in relation to him. In this case, however, GA²LEN e.V. has an extraordinary right of termination.

13. Final Provisions All disputes arising out of or in connection with this agreement are subject to the law of England and Wales and shall be subject to the exclusive jurisdiction of the courts of England. These T&C do not limit any mandatory rights that the user may have as a consumer in his own jurisdiction and will not prevent the user from raising any claim in any courts which he is entitled to due to his status as a consumer. These T&C are only binding between the user and the GA²LEN e.V. No other person shall have any rights to enforce any of these terms. As long as GA²LEN e.V. does not give its written consent, the user is not allowed to transfer his rights or obligations to another person. If GA²LEN e.V. fails to insist that the user performs any of his obligations under these T&C, it shall not constitute any waiver of any right or provision of these T&C and will not mean that the user does not have to comply with those obligations. This also applies if the GA²LEN e.V. does not enforce its rights against the user or delays such enforcement. If a court finds parts of this contract illegal, invalid or unenforceable the rest will continue in force. Each of the paragraphs and sub-clauses of these T&C 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. The invalid or unenforceable clause will be superseded by a valid and enforceable provision that most closely matches the intent of the original. Berlin, February 25th 2022