1.1. The Hypoparathyroidism Patient Experience Scale (“HPES”) questionnaire digital platform (“Platform”, as further defined below) is operated by Manyone Denmark ApS on behalf of Ascendis Pharma A/S. The Platform is a digital platform that provides access to a validated disease-specific composite measure for monitoring symptoms and quality of life impact in patients with hypoparathyroidism. The purpose of the HPES is to help measuring symptoms and signs in individual patients and standardising the language used to describe the severity of hypoparathyroidism from the perspective of individual patients.

1.2. Throughout these Terms of Use (“Terms of Use”, as further defined below), “We”, “Us” or “Our” refers to Ascendis Pharma A/S as the provider of the Platform to Users (as defined below) as well as its Affiliates (as defined below).

1.3. The Platform serves two distinct types of Users: Healthcare Providers and Patients (as defined below). Different provisions within these Terms of Use apply to these different types of Users. The User must comply with all provisions that are applicable to their specific role as either a Healthcare Provider or a Patient (as defined below). Where applicable, Sections will be clearly marked to indicate whether they apply to a single type of User.

1.4. The User may use the Platform only after agreeing to the Terms of Use, which shall establish a contractual relationship between the User and Us. When accessing the Platform, the User must accept the Terms of Use thus agreeing to them. To this end, the User will have the opportunity of reading and saving these Terms of Use in a durable manner before checking a box confirming their agreement to the Terms of Use.

2.1. For the purposes of these Terms of Use, the following terms shall have the meanings set forth below when capitalised:

2.2. “Affiliate” means any entity that controls, is controlled by, or is under common control with Ascendis Pharma A/S. For clarity, an entity “controls” another if it owns directly or indirectly a sufficient voting interest to elect a majority of the directors or has a managing authority or otherwise directs the affairs or management of such entity.

2.3. “Dashboard” means the web-based tool with Healthcare Provider login functionality that allows monitoring of Patient progression by their Healthcare Provider.

2.4. “Healthcare Provider” means a registered healthcare professional (including physicians, nurses and pharmacists) involved in the treatment of Patients affected by hypoparathyroidism, using the HPES to better monitor the impact of the hypoparathyroidism on their Patients, and who must register and log in to access the Dashboard and view Patient scores.

2.5. “Healthcare Provider Privacy Policy” means Our privacy policy relating to the use of the Platform by Healthcare Providers, accessible under the following link: Privacy Notice (HCP).

2.6. “HPES” shall have the meaning ascribed to it in Section 1.1.

2.7. “Patient” means an individual diagnosed with or being treated for hypoparathyroidism who is under the care of a Healthcare Provider using the Platform.

2.8. “Patient Privacy Policy” means Our privacy policy relating to the use of the Platform by Patients, accessible under the following link: Privacy Notice (Patient).

2.9. “Platform” means the HPES digital platform, including both the web-based Dashboard component (Register | HPES Dashboard) and the web-based HPES Patient questionnaire (only accessible via the link shared by the Healthcare Provider with the Patient).

2.10. “Privacy Policies” means both Our Patient Privacy Policy and Our Healthcare Provider Privacy Policy.

2.11. “Switching Request” means a request to enable an existing User to (i) switch to another cloud service provider covering the same services type or (ii) to switch their on-premises User infrastructure.

2.12. “Terms of Use” means these terms and conditions governing the use of the Platform.

2.13. “User” means any individual accessing the Platform, whether as a Healthcare Provider or Patient.

3.1. The User must be at least eighteen (18) years of age and possess full legal capacity to enter into binding agreements to access and use the Platform. Individuals under eighteen (18) years of age as well as individuals over eighteen (18) years of age who lack full legal capacity may only accept these Terms of Use and access and use the Platform through their legal guardian or authorised representative. In such cases, the rights and obligations of the User under these Terms of Use also apply mutatis mutandis to such legal guardian or authorised representative.

3.2. Patient access conditions:

The Patient can only access the Platform to access the HPES questionnaire through individualised HPES questionnaire links provided by their Healthcare Provider. Patient access is limited to filling out the HPES questionnaires regularly and does not include Dashboard access or similar functionality.

Patients may only use the Platform for the intended purpose of completing the HPES questionnaire to enable their Healthcare Provider to monitor their hypoparathyroidism symptoms and quality of life impact.

3.3. Healthcare Provider access conditions

To obtain access to the Platform as a Healthcare Provider, an initial registration is required, as further described in Section 4. 

We reserve the right to verify the credentials of the Healthcare Provider trying to register to the Platform to ensure the security and integrity of the Platform and to ensure patient safety.

Healthcare Provider access is tied to a specific medical practice. In the event of changes affecting the Healthcare Provider’s practice, the Healthcare Provider access may be terminated pursuant to Section 11.

4.1. Pursuant to Section 3.3, access to the Platform as a Healthcare Provider requires an initial registration. The registration process consists of the following steps:

4.1.1. Access to the Platform is only available through the link provided by Us or through self-registration on the dedicated webpage.

4.1.2. Upon accessing the registration page of the Platform by clicking on the registration link received, the Healthcare Provider must provide the requested mandatory information, including:

• First and last name,

• Email address,

• Name of the medical practice,

• Country, and

• Password.

4.1.3. Once the registration has been carried out, the Healthcare Provider can log into the Platform and access their Dashboard.

4.2. Upon accessing their Dashboard, Healthcare Providers will have the opportunity of adding Patients thereto. Healthcare Providers warrant that appropriate consent has been obtained before adding Patients to their Dashboard.

4.3. To add a Patient to their Dashboard, the Healthcare Provider must then provide the requested information, which may include the Patient’s:

• First and last name,

• Year of birth, and

• Email address.

4.4. The Healthcare Provider is responsible for maintaining accurate and up to date registration and Patient information. The Healthcare Provider must promptly update their account information or any Patient information if any changes occur.

4.5. The Healthcare Provider is responsible for maintaining the security and confidentiality of their account credentials. Subject to Section 4.6, the Healthcare Provider must keep their password confidential and secure.

4.6. Each Healthcare Provider account is intended for use by a single individual or medical practice only. To the exception of other professionals which are part of the same medical practice as them (e.g., medical assistants or other Healthcare Providers), the Healthcare Provider may not allow other persons to use their account or share their login credentials or account with third parties without Our prior written consent. The Healthcare Provider is responsible for all activities occurring under their account.

4.7. The Healthcare Provider understands that the Platform does not contain a functionality allowing them to report adverse events within treatments of hypoparathyroidism to the relevant national authority or to the marketing authorisation holder of the relevant drug.

5.1. The Patient is hereby granted a non-transferable, non-exclusive, revocable and limited right to access and use the Platform for the purpose of filling out the HPES questionnaire. Such use is strictly limited to the intended medical and healthcare purposes for which the Platform and HPES questionnaire were designed, specifically the monitoring of hypoparathyroidism symptoms and quality of life impact through the HPES questionnaire. Any use outside of this intended scope is strictly prohibited.

5.2. The Healthcare Provider is hereby granted a non-transferable, non-exclusive, revocable and limited right to access and use the Dashboard functionality of the Platform, for the purpose of (i) inviting Patients to fill out the HPES questionnaire on the Platform by sending them an individualised link, (ii) managing the profiles of the Patients which are part of their Dashboard, (iii) viewing Patient scores and questionnaire results, (iv) monitoring Patient progression over time, and (v) accessing historical questionnaire data for Patients which are part of their Dashboard.

5.3. If and to the extent computer programs within the meaning of Section 69a para. 1 of the German Copyright Act (Urheberrechtsgesetz) are made available to the User as part of their use of the Platform, the User shall only have the right to make a copy of such computer program which is required for the loading, display, running, transfer or storage thereof to observe, inspect and test its functions as well as the right to make a copy of the computer program for backup purposes as stated in Section 69d para. 2 of the German Copyright Act. Decompilation of the computer program is prohibited, unless it is necessary for the purpose of establishing interoperability between an independently created computer program and a computer program provided to the User or other computer programs, subject to the restrictions specified in Section 69e of the German Copyright Act.

5.4. The User may not transfer, assign, sublicense, or otherwise grant rights in the Platform to any third party without Our prior written consent.

5.5. The User grants Us a transferable, non-exclusive, revocable and limited right to process the content they submit to the Platform for the purpose of providing them with the functionalities of the Platform as described in these Terms of Use.

6.1. The User must use the Platform only in accordance with these Terms of Use and for the intended monitoring purpose of the Platform. Any use outside of this intended monitoring purpose is strictly prohibited.

6.2. The User is responsible for obtaining and maintaining, at their own expense, all hardware, software, and internet connectivity necessary to access and use the Platform.

6.3. The Healthcare Provider must:

• Collect valid consent from the Patients to receiving HPES questionnaire communications from Us before entering them into the Platform or adding any Patient to their Dashboard. The information provided to the Patient in this context must generally reflect the details outlined in the Patient Privacy Policy,

• Treat as confidential the data of Users of which they have become aware in the course of using the Platform,

• Comply with any applicable law in relation to the handling of Patient data including, but not limited to, data protection legislation, 

• Delete the Patient’s profile that they added to their Dashboard upon Patient’s request of such deletion, and

• Comply with their professional obligations, maintain valid professional licensing and remain in good standing with applicable medical regulatory authorities throughout their use of the Platform.

6.4. The Platform is not intended for medical diagnosis, treatment decisions, or emergency medical situations. The Healthcare Provider must exercise their own professional medical judgement when interpreting questionnaire results and making clinical decisions. Patient scores and data provided through the Platform should supplement, not replace, comprehensive clinical assessment and professional medical expertise. In case of medical emergencies, the Healthcare Provider must not rely on the Platform for urgent medical assistance.

6.5. The Patient must:

• Access the Platform solely through the individualised HPES questionnaire link provided,

• Use the Platform solely for answering questions of the HPES questionnaire,

• Keep their individualised HPES questionnaire link private and confidential, and

• Contact their Healthcare Provider directly for any medical concerns or emergencies.

7.1. The User shall not jeopardise the integrity, stability, security or availability of the Platform, including by:

• Attempting to gain unauthorised access to any part of the Platform,

• Interfering with or disrupting the Platform's servers or networks,

• Introducing viruses, malware, or other harmful code, or

• Attempting to bypass security measures or access controls.

7.2. The Healthcare Provider is specifically prohibited from using the Platform for any commercial purposes beyond the intended healthcare monitoring function. The Healthcare Provider is also explicitly prohibited from selling any Patient personal data of which they have become aware in the course of using the Platform, and/or otherwise sharing Patient data with third parties, unless they are legally permitted to do so.

7.3. Subject to Section 3.1, the Patient may not allow other persons to use their individualised HPES questionnaire link or share it with third parties.

7.4. The User acknowledge that any violation of prohibitions of this Section 7 may result in the immediate termination by Us of their access to the Platform pursuant to Section 11.5.

8.1. We provide the Platform to the User to the extent described in these Terms of Use. The provision of the Platform occurs at the router output of the data center where the Platform is hosted. We warrant that the Platform is operational and does not infringe any third-party rights.

8.2. We shall not be responsible for providing the User with the internet connection to the data center where the Platform is hosted, or the hardware and software that the User requires to access and/or use the Platform. We shall also not be responsible for ensuring that such internet connection and hardware and software are free from defects or are not affected by technical disruptions. We are also not responsible for ensuring that the use of the Platform is not impaired when such impairment results from circumstances that are outside Our area of responsibility. This applies, for example, to impairments resulting from the User’s misuse of the Platform or malfunctions of the User’s hardware or software.

8.3. We shall not be responsible nor is it possible for Us to ensure that data provided by the User to the Platform and that is merely processed by Us is complete and accurate. In the event of data loss, We shall not be liable to the extent that such loss is based on the User’s failure to perform data backups and thereby ensure that lost data can be restored with reasonable effort, or that the User has not fulfilled their obligations in handling data stored in the Platform and in maintaining the confidentiality of their access credentials, if applicable.

8.4. We will make reasonable efforts to ensure that the Platform is available for uninterrupted use but are not obliged to ensure a continuous availability and complete accessibility of the Platform.

8.5. In addition, We reserve the right to modify functionalities and features of the Platform at any time, upon providing the User with reasonable prior notice. Such modifications may include, for example, adding, removing or altering Platform features, or updating the User interface of the Dashboard functionality.

8.6. We also reserve the right to suspend or terminate the Platform, or individual functionalities and features thereof, at our reasonable discretion, including expanding, restricting, or terminating functions in whole or in part, provided that We have provided the User with reasonable prior notice regarding the suspension or termination and subject to Sections 8.7 and 11.7.

8.7. In the event of Platform termination, We will provide the User with advance notice to allow for the export or transfer of Patient content pursuant to Section 11.7. However, We do not guarantee the availability of data export functionality or the preservation of data beyond the data retrieval period as outlined in Section 11.7.5.

8.8. In the event of change, suspension or termination of the Platform in accordance with the Terms of Use, We shall only be liable for any damages incurred by Users as a result of such change, suspension, or termination to the extent provided in Section 13.1.

9.1. All rights relating to intellectual property (such as trademarks and copyrights) associated with the Platform belong to Us or to our licensors.

9.2. Unless expressly provided under these Terms of Use, Users shall not have any rights to the intellectual property associated with the Platform, and shall in particular not copy, edit, modify, publish, broadcast, distribute, transfer, translate, or adapt any such intellectual property associated with the Platform without Our express prior written consent.

9.3. We shall not own any data provided by Healthcare Providers or Patients on the Platform. In particular, Patient questionnaire responses shall remain the Patient’s property. We shall only process personal data as detailed in Section 10 below and in our Privacy Policies.

10.1. Use of the Platform involves the processing of personal data. For detailed information on how We collect, use, store, and protect personal data, please refer to Our Privacy Policies.

10.2. Healthcare Providers shall only process personal data of Patients for the purposes of (i) adding Patients to their Dashboard, (ii) tracking their hypoparathyroidism symptoms and quality of life impact through the HPES questionnaire monitoring system, (iii) maintaining accurate and up-to-date registration, account details and Patient information, and (iv) deleting the Patient’s profile upon the Patient’s request. In this context, Healthcare Providers shall comply with applicable data protection legislation, including but not limited to the EU General Data Protection Regulation (EU) 2016/679 (“GDPR”) and be responsible for such compliance.

10.3. When a Healthcare Provider stops working or moves practice, they must deactivate their account, their access to the Platform will be terminated and the following process will apply:

10.3.1. The Healthcare Provider's account will be deactivated and associated data will be anonymised.

10.3.2. The Patients part of the Healthcare Provider’s Dashboard will be notified of the deletion of their data following the timelines of automatic deletion (See section 11.5 below)

10.3.3. All deletion procedures will be conducted in accordance with the Privacy Policies and applicable data protection laws.

11.1. The Patient may terminate their access to the Platform and delete their data stored thereon by either using the deactivation link provided with each individualised HPES questionnaire link or by contacting their Healthcare Provider to request such deletion of their information.

11.2. Healthcare Providers may terminate their account at any time through the use of the corresponding functionality on the Platform.

11.3. Upon termination of a Healthcare Provider account:

• Dashboard access will be immediately revoked,

• Account credentials will be deactivated,

• All account and associated Patient data will be processed for deletion in accordance Section 10.3 above.

11.4. Accounts of Healthcare Provider may be automatically terminated and associated data anonymised after fifteen (15) months of inactivity. The Healthcare Provider will receive a notice informing them of the termination and deletion of their account sixty (60), thirty (30) and three (3) days before the end of this fifteen-months period.

Accounts of Patients may be automatically terminated and associated data deleted after fourteen (14) months of inactivity. The Patient will receive a notice informing them of the termination and deletion of their account sixty (60), thirty (30) and three (3) days before the end of this fourteen-months period.

11.5. We may immediately terminate User access or Healthcare Provider accounts in case of failure to comply with these Terms of Use or in the event of changes affecting the Healthcare Provider’s practice, as stated in Section 3.3.

11.6. Upon termination, all rights and licences granted under these Terms of Use immediately cease, and the User must discontinue all use of the Platform.

11.7. The User shall have the right to submit a Switching Request to initiate the switching process any time during their lawful use of the Platform. If applicable, the switching process shall take place as follows:

11.7.1. The Patient can submit the Switching Request by clicking on the corresponding link included in any email received in relation to the Platform.

11.7.2. The Healthcare Provider can submit the Switching Request by clicking on the corresponding link displayed on the Platform.

11.7.3. The User shall submit their Switching Request taking into account a notice period of one (1) month prior to the initiation of the switching process. The switching process will be initiated at the latest at the expiry of the one (1) month notice period.

11.7.4. The Switching Request shall include the following information:

• the confirmation for the initiation of the date of the switching process,

• the reason for switching,

• if the switching will be to a new cloud service provider (destination), to an on-premises ICT infrastructure or to use several cloud service providers at the same time (multi-cloud),

• how the User exportable data and digital assets will be ported or erased by the User, and

• the details of the new cloud service provider (destination), if applicable.

11.7.5. During a transitional period of thirty (30) days starting one (1) month after the Switching Request has been received, the User can request switching processing assistance by Us to the extent technically and reasonably feasible by Us to complete the porting of the User’s exportable data and digital assets.

11.7.6. The User’s exportable data and digital assets, as exhaustively listed in the document accessible under the following link: List of exportable data and digital assets, will be provided as a downloadable file in CVS format. For the sake of clarity, the Healthcare Provider’s exportable data shall not comprise any Patient data. If the Healthcare Provider also wishes to export exportable data of Patients (as listed in the aforementioned link), a corresponding Switching Request shall be submitted by each relevant Patient.

11.7.7. The User’s use of the Platform under these Terms of Use shall be terminated at the date notified by Us to the User upon the earlier of (i) successful completion of the switching process upon receipt of the User’s confirmation that the User’s exportable data and digital assets have been transferred, or (ii) expiry of a data retrieval period of thirty (30) days from the end of the one-month notice period following receipt of the Switching Request, where the User does not wish to switch but to erase their exportable data and digital assets.

11.7.8. All data management and deletion procedures following termination will be conducted in accordance with our Privacy Policies, accessible under the following links: Privacy Notice (HCP), Privacy Notice (Patient).

12.1. We warrants the functional and operational readiness of the Platform in accordance with the provisions of these Terms of Use, in particular as outlined in Sections 8.1 to 8.4.

12.2. The User warrants that they have the necessary rights and permissions to provide content or data to the Platform including, where required, valid consent from the Patient, to process their personal data on the Platform as outlined in Section 6.3. 

12.3. The User warrants that they understand that the Platform is not intended for any medical diagnosis or treatment decisions.

13.1. We shall not be liable for any claims for damages or liability cases, except for claims

• arising out of a grossly negligent or intentional breach of duty by Ascendis Pharma A/S, by Our legal representative, or a person used to perform Our obligation,

• arising out of an injury to life, body or health due to intentional or negligent breach of duty by Ascendis Pharma A/S, Our legal representative, or a person used to perform Our obligation,

• arising out of the lack of any guaranteed quality up to the amount which is covered by the purpose of the guarantee, and which was foreseeable by Us at the time the guarantee was given,

• based on the German Product Liability Act (Produkthaftungsgesetz), or

• based on any mandatory liability under applicable data protection laws, including the GDPR,

• due to a culpable breach of material contractual obligations, in which case however the claim for damages is limited to the foreseeable damage typical for the contract, unless another of the cases listed above in this Section 13.1 applies at the same time.

13.2. If and to the extent We would be liable regardless of fault for a defect already existing at the time of conclusion of these Terms of Use pursuant to Section 536a para. 1, first alternative of the German Civil Code (Bürgerliches Gesetzbuch), such liability shall be excluded.

13.3. If we are unable to perform Our obligations under these Terms of Use due to a force majeure event, we shall not be held liable. A force majeure event includes in particular, strikes, governmental measures, unforeseeable failure of means of transport or energy, and other unavoidable events, even if these circumstances occur at one of our suppliers who is not considered a vicarious agent.

13.4. The above Sections 13.1 to 13.3 shall also apply in favour of our legal representatives, executives, or other vicarious agents.

13.5. Pursuant to Section 6.4 and subject to Section 13.1, We shall not be held liable for any medical decisions made based on information obtained through the Platform. Healthcare Providers remain solely responsible for all clinical decisions and Patient care.

14.1. We shall indemnify, defend, and hold harmless the User from and against any third-party claims alleging that the Platform, when used in accordance with these Terms of Use, infringes any third-party intellectual property rights, provided that (i) such claim is promptly notified to Us, (ii) We may have the sole control of the defence and settlement of the claim and (iii) the User provides reasonable cooperation in the defence of the claim. This indemnification shall not apply to claims arising from User modifications to the Platform, use in combination with third-party products not approved by Us, or use outside the scope of these Terms of Use.

14.2. The User shall indemnify, defend, and hold harmless Ascendis Pharma A/S, Our Affiliates, officers, directors, employees, and agents from and against any and all claims, damages, losses, costs, and expenses (including reasonable legal fees) arising from or relating to their use of the Platform or their violation of these Terms of Use. We shall promptly notify such claim to the relevant User and provide reasonable cooperation in the defence of the claim.

14.3. The Healthcare Provider shall additionally indemnify, defend, and hold harmless Ascendis Pharma A/S, Our Affiliates, officers, directors, employees, and agents from and against any and all claims, damages, losses, costs, and expenses (including reasonable legal fees) arising from or relating to their unauthorised processing of Patient personal data, their failure to obtain a valid Patient consent, or their breach of professional obligations or medical standards.

15.1. We reserve the right to update these Terms of Use, particularly for the purpose of adapting them to legal or technical changes. The User will be informed about updates via prior notification on the Platform and will have the opportunity to accept the updated Terms of Use before accessing the Platform.

16.1. These Terms of Use and the use of the Platform are governed by the laws of the Federal Republic of Germany, to the exclusion of its conflict of laws provisions as well as the United Nations Convention on Contracts for the International Sale of Goods. In the event that you have your habitual residence in another member state of the European Union, the mandatory provisions of that state remain unaffected.

16.2. As a rule, the courts of the Federal Republic of Germany shall have the exclusive jurisdiction to settle any dispute or claim arising out of, or in connection with these Terms of Use. If the User moves their domicile or habitual residence outside Germany after conclusion of these Terms of Use or if the User’s domicile or habitual residence is not known at the time a legal action is brought against them, the place of jurisdiction shall be Heidelberg, Germany. The rights the User might have as a consumer habitually residing in another member state of the European Union shall remain unaffected.

17.1. Severability

If any provision of these Terms of Use is found to be invalid, illegal, or unenforceable by a court of competent jurisdiction, such provision shall be deemed severed from these Terms, and the remaining provisions shall continue in full force and effect. In such event, the parties agree to replace the invalid, illegal, or unenforceable provision with a valid and enforceable provision that achieves, to the greatest extent possible, the original intent of the severed provision.

17.2. Assignment

We may assign, transfer, or delegate any or all of Our rights and obligations under these Terms of Use to any third party, including but not limited to Affiliates, or in connection with a merger, acquisition, corporate reorganisation, or sale of assets. The User will be notified of any such assignment that materially affects their rights under these Terms of Use.

The User may not assign, transfer, or delegate any of their rights or obligations under these Terms of Use without Our prior written consent.

1. Healthcare Provider’s exportable data and digital assets 

• First name,

• Last name,

• Email,

• Name of clinic/medical practice,

• Country code,

• Medical practice ID,

• Date and time of the acceptance of the terms and conditions,

• Date and time of the acceptance of the privacy policy, and

• Date and time of the last activity on the Platform.

2. Patient’s exportable data and digital assets 

• First name,

• Last name,

• Year of birth,

• Email,

• Questionnaire data,

• Patient ID,

• Medical practice ID,

• Country,

• Date and time of the acceptance of the terms and conditions,

• Date and time of the acceptance of the privacy policy, and

• Date and time of the last activity on the Platform.