ONWARD Medical
Global Privacy Policy

Last updated: November, 2023

Welcome to the website of ONWARD Medical N.V. (“ONWARD”, “we”, “us” and/or “our”). ONWARD is a company that specializes in developing and commercializing targeted, programmed stimulation therapies of the spinal cord with its ARC Therapy™, which includes the ARC^EX and ARC^IM Systems (“Research”). ARC Therapy™, ARC^EX and ARC^IM are investigational and not available for commercial use. Our website (“Site”) allows you to easily access and use content, including features, resources and other information intended to help you learn about ONWARD’s Research, our technological developments, and to provide information about our latest developments and marketing information for investors, researchers, and potential study participants, among others.

ONWARD intends to process Personal Data in accordance with applicable data protection privacy principles, including applicable laws and regulations in the countries where we conduct clinical trials and where we have operations. ONWARD understands the importance of privacy and the protection of Personal Data and is committed to ensuring an adequate level of data protection for everyone ONWARD collects data from. This includes:

• Clinical study participants and their caregivers;

• Patients;

• Healthcare professionals and researchers;

• Users of our products and services, including website users;

• Contractors, vendors and business partners;

• Representatives of the scientific community; and

• Job applicants.

This Privacy Policy explains ONWARD´s general data handling practices for all data processing, including what Personal Data (defined below) we collect from users when you visit our website or request information about a clinical trial and through the Site, how we use and share that data, and your choices concerning our data practices. This Privacy Policy forms part of our Terms of Use, which are available at www.onwd.com/terms-of-use.

By providing us with your Personal Data when engaging with the Site or participating in Research, you agree to the practices described in this Privacy Policy. If you do not agree to this Privacy Policy, please do not access or use the Site or participate in Research.

Information We Collect and How We Use It:

By using our website, you provide us with a certain amount of information about yourself, some of which may identify you (“Personal Information”). This is the case when you browse our site or when you fill in online forms.

The nature and quality of the Personal Data collected about you will vary depending on the relationship you have with ONWARD, the main ones being:

Identification data: This includes all information that would allow us to identify you, such as your name, first name, telephone number, e-mail address and postal address. We may also collect information you provide us regarding your relationship to ONWARD’s activities, as well as any further information you include in the “free text” boxes in online forms, such as on the “Information request” or “Contact us” pages,

Browsing information: by browsing our website, you interact with it. As a result, some information is collected, such as your IP address, browser type and settings, the date and type of your request, and how you interacted with the site. This includes the type of content that you view or engage with, the features you use, the actions you take, the other users you interact with and the time, frequency and duration of your activities,

Device information: We may also collect information on the type of device you are using, operating system, settings, unique device identifiers, network information and other device-specific information. Information collected may depend on the device you are using,

Medical research information: This includes all information that would be provided by Our Research Partners’ including but not limited to health data. The information will be de-identified before being provided to ONWARD.

Cookies: Information from cookies stored on your device. Please see our Cookie Policy to learn more about how we use cookies and other technologies.

How We Use Personal data:

As necessary for certain legitimate business interests, which include the following:

• To authenticate users and provide access to the Site;

• To respond to your inquiries and fulfill your requests for products, services, and information;

• To provide, maintain and improve the content and functionality of the Site. For example, we regularly fix bugs or user experience issues that may be tied to particular user accounts. We use cookies to analyze how users interact with our Site, and that analysis can help us build a better Site;

• If you ask us to delete your data and we are required to fulfil your request, to keep basic data to identify you and prevent further unwanted processing;

• To prevent fraud or criminal activity, misuse of our products or services, and ensure the security of our IT systems, architecture and networks; and

• To (a) comply with legal obligations and legal process; (b) respond to requests from public and government authorities including public and government authorities outside your country of residence; (c) enforce our Terms of Use; (d) protect our operations or those of any of our affiliates; (e) protect our rights, privacy, safety or property, and/or that of our affiliates, you or others; and (f) allow us to pursue available remedies or limit the damages that we may sustain, as required or permitted by the law.

With your express consent, where you have clearly consented to ONWARD’s processing of your Personal Data. In practice, this will generally mean that ONWARD will ask you to sign a document, or to fill-in an online “opt-in” form or take other steps where you either clearly accept or refuse the data processing we describe.

To perform a contract between you and ONWARD or its representative, including to provide services you request.

To comply with a legal obligation applicable to ONWARD’s activities; for instance, ONWARD is required to implement procedures to monitor adverse effects of marketed products or products being tested in clinical trials, which generally involves the collection and retention of Personal Data.

ONWARD may, on a case-by-case basis, rely on other legal grounds, such as the protection of your vital interests, in accordance with applicable data protection law, as set forth in elsewhere in this Privacy Policy or other applicable privacy notice.  For individuals in the European Union (“EU”), please see the “European Union (EU) Users” section below for more information about your rights.

Sharing and Disclosure of Information

We may share or disclose your information at your direction, such as when you authorize a third-party service to access your account or when you voluntarily share information or content via the Services.

There are certain circumstances in which we may share your Personal Data with certain third parties without further notice to you, unless your consent is required by law, as set forth below:

• Vendors, Service Providers, and Research Partners: To assist us in conducting Research and to perform certain Research services and functions, including providers of clinical trial operations services such as trial site personnel, investigators, clinical research organizations (“CROs”), and others conducting Research-related activities on our behalf (“Research Partners”); providers of administrative services such as email communication (including appointment reminders, investment information you request through the Site) and Site support services; to assist us in meeting business operations needs and to perform certain services and functions; and analytics (for more details on the third parties that place cookies through the Site, please see the “Cookies” section below). For example, we use Google Analytics to understand how our Site is used, and Webpress for hosting. Pursuant to our instructions, these parties will access, process or store Personal Data in the course of performing their duties to us.

• Business Transfers or Acquisitions: If we are involved in a merger, acquisition, financing due diligence, reorganization, bankruptcy, receivership, sale of all or a portion of our assets, or transition of service to another provider, your Personal Data and other information may be transferred to a successor or affiliate as part of that transaction along with other assets.

• Legal Requirements: If required to do so by law, including US and applicable EU member state or United Kingdom law, or in the good faith belief that such action is necessary to (a) comply with a legal obligation, (b) protect and defend our rights or property, (c) act in urgent circumstances to protect the personal safety of users of the Site or the App, or the public, or (d) protect against legal liability.

Data Retention

We will keep your Personal Data for as long as reasonably necessary for the purposes described in this Privacy Policy, while we have a legitimate business need to do so, or as required by law (e.g. for regulatory reporting including to government entities who may oversee the safety and efficacy of Research, legal, tax, accounting or other purposes), whichever is the longer. For Personal Data collected as part of Research, unless otherwise required in order for us to comply with industry regulations or law, we will only retain your Personal Data for ten years from the moment it is collected.

To determine the appropriate retention period for your Personal Data, we will consider the amount, nature, and sensitivity of the Personal Data, the potential risk of harm from unauthorized use or disclosure of your Personal Data, the purposes for which we use your Personal Data and whether we can achieve those purposes through other means, and the applicable legal requirements.

We will only retain your Personal Data for as long as necessary to fulfil the purpose for which they were collected, and to comply with legal or regulatory requirements which mandate retention or statutory periods within which legal claims can be made. As a general principle, the retention period for your Data is five (5) years from the last contact or contract expiry date. If the purpose for which your Data has been collected is listed below, then the retention period shall be the period indicated as follows:

California Privacy Disclosure

Do Not Track Signals: The Site currently does not respond to “Do Not Track” (“DNT”) signals and operates as described in this Privacy Policy whether or not a DNT signal is received. If we do respond to DNT signals in the future, we will update this Privacy Policy to describe how we do so.

European Union (EU) Users Scope

This section applies if you are an EU User (for these purposes, reference to the EU also includes the European Economic Area countries of Iceland, Liechtenstein and Norway).

Data Controller. ONWARD is the data controller for processing Personal Data provided to us through your interactions with the Site and your participation in Research. To find out our contact details, please see the “Contact Us” section below.

If you are an individual in the EU, and would like to contact ONWARD’s Data Protection Officer on matters related to the processing of Personal Data, or otherwise exercise your rights in respect of your personal data (described below), please contact privacy@ONWD.com.

Your Rights. Subject to applicable EU law, you may have the following rights in relation to your Personal Data that we hold about you, depending upon whether the Personal Data was collected for Research purposes or through use of our Site, and depending upon the EU member state in which you reside:

• Right of Access: If you ask us, we will confirm whether we are processing your Personal Data and, if so, provide you with a copy of all Personal Data you are lawfully entitled to receive along with certain other details. If you require additional copies, we may need to charge a reasonable fee.

• Right to Rectification: If your Personal Data is inaccurate or incomplete, you are entitled to ask that we correct or complete it. If we shared your Personal Data with others, we will tell them about the correction where possible. If you ask us, and where possible and lawful to do so, we will also tell you with whom we shared your Personal Data so you can contact them directly.

• Right to Erasure: You may ask us to delete or remove your Personal Data, such as where you withdraw your consent, where applicable. If we shared your data with others, we will tell them about the erasure where possible. If you ask us, and where possible and lawful to do so, we will also tell you with whom we shared your Personal Data with so you can contact them directly. However, due to the public interest in the availability of clinical trial data, this right may not apply to Personal Data collected during Research.

• Right to Restrict Processing: You may ask us to restrict or ‘block’ the processing of your Personal Data in certain circumstances, such as where you contest the accuracy of the data or object to us processing it (please read below for information on your right to object). We will tell you before we lift any restriction on processing. If we shared your Personal Data with others, we will tell them about the restriction where possible. If you ask us, and where possible and lawful to do so, we will also tell you with whom we shared your Personal Data so you can contact them directly. If you are a clinical trial Research participant, you may not be able to restrict the processing of Personal Data.

• Right to Data Portability: You have the right to obtain your Personal Data from us that you consented to give us or that was provided to us as necessary in connection with our contract with you, and that is processed by us by automated means.  We will give you your Personal Data in a structured, commonly used and machine-readable format.  You may reuse it elsewhere. However, this right may not apply to Personal Data from Research participants.

• Right to Object: You may ask us at any time to stop processing your Personal Data, and we will do so:

– If we are relying on a legitimate interest to process your Personal Data — unless we demonstrate compelling legitimate grounds for the processing or

– If we are processing your Personal Data for direct marketing.

• Right to Withdraw Consent: If we rely on your consent to process your Personal Data, you have the right to withdraw that consent at any time. Withdrawal of consent will not affect any processing of your data before we received notice that you wished to withdraw consent.

• Rights in Relation to Automated Decision-making: You have the right to be free from decisions based solely on automated processing of your Personal Data, (including profiling) unless this is necessary in relation to a contract between you and us or you provide your explicit consent to this use.

• Right to Lodge a Complaint with the Data Protection Authority: If you have a concern about our privacy practices, including the way we handled your Personal Data, you can report it to the data protection authority that is authorized to hear those concerns. Please see the “Contact Us” section below for information on how to contact us to exercise your rights.

To exercise your rights, you may contact the Data Protection Officer (DPO): privacy@ONWD.com.

When you send us a request to exercise a right, you are asked to specify as far as possible the scope of the request, the type of right being exercised, the Personal Data Processing concerned, and any other useful information, in order to facilitate the examination of your request. In addition, in case of reasonable doubt, you may be asked to prove your identity.

Children in the EU: The Site is not directed to EU data subjects who are children who are under the age of 16. ONWARD does not knowingly collect Personal Data from children who are under 16.  If you have reason to believe that a child under the age of 16 has provided Personal Data to ONWARD through the Site please contact us and we will endeavor to delete that information from our databases.

Children in The US:

The Site is not directed to children who are under the age of 13. ONWARD does not knowingly collect Personal Data from children who are under 13.  If you have reason to believe that a child under the age of 13 has provided Personal Data to ONWARD through the Site please contact us and we will endeavor to delete that information from our databases.

Links to Other Websites

This Privacy Policy only applies to the Site and our conduct of Research. The Site may contain links to other websites not operated or controlled by ONWARD (“Third Party Sites”), including social media services such as Facebook, Twitter, YouTube, Vimeo, or LinkedIn (“Social Media Services”). The information that you share with Third Party Sites will be governed by the specific privacy policies and terms of service of the Third Party Sites and not by this Privacy Policy. We do not own, control or operate such linked sites, and we are not responsible for the privacy policies or practices of such linked sites. By providing these links, we do not imply that we endorse or have reviewed these sites. Privacy policies and practices for such linked sites may differ from this Privacy Policy and our practices. We encourage you to read the privacy policies of such linked sites before disclosing personal information on Third Party Sites.

Other Terms and Conditions

Your access to and use of the Site is subject to any additional terms applicable to such Site that may be posted on the Site  from time to time, including without limitation, ONWARD’s Terms of Use at www.onwd.com/terms-of-use. If you enroll, your participation in Research is subject to any additional terms applicable to such Research, including without limitation, any informed consent to participate in Research you may have executed, or privacy notice you may have received.

Changes to the Privacy Policy

The Site, our Research, and our business may change from time to time. As a result, we may change this Privacy Policy at any time and, when we do, we will post an updated version on this page and change the Last Updated date above, unless another type of notice is required by the applicable law. You should consult this Privacy Policy regularly for any changes.  By continuing to use the Site or participate in Research, or providing us with information after we have posted an updated Privacy Policy, or notified you if applicable, you consent to the revised Privacy Policy and practices described in it.

International Users and Data Transfers

ONWARD is based in the European Union and has operations in the United States. If you are accessing our Site, or participating in Research, from or in the European Union or other regions with laws governing data collection and use, please note that your Personal Data may be transmitted to our servers in the United States as necessary to for your participation in Research, provide you with the information that you requested, administer our contract with you or to respond to your requests as described in this Privacy Policy, and the data may be transmitted to our service providers supporting our business operations (described above). The United States may have data protection laws less stringent than or otherwise different from the laws in effect in the country in which you are located. Where we transfer your Personal Data out of the EU we will take steps to ensure that your Personal Data receives an adequate level of protection where it is processed and your rights continue to be protected. If not, we will use the Standard Contractual Clauses of the European Commission.

Data Security

We have implemented a variety of commercially reasonably and industry standard technological and organizational procedures and measures to ensure the integrity and confidentiality of your Personal Data from unauthorized access, use and disclosure.

Exclusions

This Privacy Policy shall not apply to any unsolicited information you provide to ONWARD through your use of the Services or through any other means. This includes, but is not limited to, information posted to any public areas of the Services, any ideas for new products or modifications to existing products, and other unsolicited submissions (collectively, “Unsolicited Information”). All such Unsolicited Information shall be deemed to be non-confidential and ONWARD shall be free to reproduce, use, disclose, and distribute such Unsolicited Information to others without limitation or attribution.

Contact Us

Please feel free to contact us if you have any questions about ONWARD’s Privacy Policy or the information practices of the Services.

You may contact us as follows: You may send an email to privacy@onwd.com or send a letter to:

ONWARD Medical N.V.
Attention: Data Protection Officer
Schimmelt 2
5611 ZX Eindhoven
Netherlands

You can also directly contact your supervisory authority.