April, 2026

TopAlliance Biosciences Europe Limited Privacy Notice

General

TopAlliance Biosciences Europe Limited (also referred to as “TopAlliance EU”, “we”, “us” or “our”) as Controller of your data is committed to respect your privacy and ensure the protection of your Personal Information in line with the Regulation (EU) 2016/679, the EU General Data Protection Regulation (“EU GDPR”), UK General Data Protection Regulation (“UK GDPR”), UK Data Protection Act 2018, and UK Data (Use and Access) Act 2025, to the extent applicable to our services to you.

This privacy notice (“Privacy Notice”) describes how we collect, use, disclose, store, protect and otherwise control your personal information which you provide to TopAlliance EU over our Website (https://www.topalliancebio.com/loqtorzi-eea-uk-2/) (also referred to as “Site”) or which is gathered via the Website. This Privacy Notice also informs you of your rights and how to get access to your personal information. This Privacy Notice does not cover other services that we may offer or provide and does not cover information we receive from third parties.

If you have any questions regarding this Privacy Notice, please contact us at DPO@topalliancebio.com

By accessing the Site, you agree to be bound by this Privacy Notice, as well as its general terms of use. If you do not agree to the terms of this Privacy Notice, please do not use the Site.  Each time you use the Site, the current version of this Privacy Notice will apply.

  1. Definitions

Personal information

Personal information is any information or set of information about an identified or identifiable individual, including, but not limited to: (a) first name or initial and last name; (b) home or other physical address; (c) telephone number; (d) email address or online identifier associated with the individual; (e) Social Security number or other similar identifier; (f) employment, financial or health information; or (g) any other information relating to an individual that is combined with any of the above. The term “Personal Information” does not include anonymized information or information that is reported in the aggregate (provided that such aggregated information is not identifiable to a natural person). Any reference to “Personal Information” in this Privacy Notice are equivalent to “Personal Data” governed by the General Data Protection Regulation n° 2016/679 (“GDPR”).

Non-personal information

Any information that is not Personal Information as defined above.

Data processing

Any operation or set of operations which are performed on personal data or on sets of personal data, whether by automated means or not, such as collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

  1. What personal information do we collect?

Primarily, your personal data will be gathered directly from you through the completion of the “Report Product Quality Compliant Form” when using our website to report product quality issues.

As a person completing the form you may belong to one of the following categories:

  • Healthcare professional
  • Hospital pharmacy personnel
  • Distributor / Storage warehouse personnel
  • Patient / Customer
  • Other

When completing the form, you are asked to enter personal information such as: your full name, e-mail address, phone number, profession and country/region.

  1. How do we use your personal information?

The information we collect will be used for purposes related to the handling of product quality complaints and associated regulatory obligations, including:

  • To receive, record, assess, and investigate product quality complaints relating to our medicinal products
  • To contact you for follow-up information where necessary to ensure a complete and accurate assessment of the complaint
  • To share relevant information with affiliated companies, service providers, and competent authorities where required for the investigation and management of the complaint
  • To maintain records and documentation in accordance with applicable regulatory retention requirements
  1. On what basis do we use your personal information?

TopAlliance EU processes personal data submitted in Product Quality Complaints Form (“PQCs” Form) primarily on the basis of legal obligations under EU/UK pharmaceutical quality regulations, as we must assess, document, and maintain PQCs records. We also rely on legitimate interests to ensure product quality, investigate defects, and communicate with complainants as required for proper PQCs handling.

From our website, you may use third party social media widgets/tools/buttons. If you use that functionality, your use is subject to the third party’s privacy notices and terms. As with all links to non-TopAlliance EU websites/ services, we recommend that you read the privacy notices and terms associated with third party properties carefully.

  1. How long do we keep your data?

The data retention period varies according to the different purposes of processing. To determine the appropriate retention period for personal information, we consider the amount, nature, and sensitivity of the personal information, the potential risk of harm from unauthorized use or disclosure of your personal information, the purposes for which we process your personal information and whether we can achieve those purposes through other means, and the applicable legal requirements.

We will keep your personal data for the duration of the legally obliged storage and limitation periods (fiscal and administrative). If such an obligation does not apply, we will keep your data no longer than necessary.

At all times you have the right to request removal of your personal data from our systems. Should however any legal ground prevents TopAlliance EU to remove your personal data from its systems you will be informed what personal data we are obliged to keep and the reasons for keeping it.

  1. How do we protect your information?

We take appropriate security measures to prevent your personal data from being accidentally or unlawfully destroyed, lost, used, accessed, altered or disclosed. Your personal data is stored at a safe and secured location that is only accessible to the authorised TopAlliance EU personnel. They only process your personal data under our documented instructions, and they are subject to a duty of confidentiality.

  1. What are your rights regarding your personal data?

With regard to the processing of your personal data you have the following right under EU and UK GDPR:

  • Access: you have the right to obtain confirmation as to whether or not personal data concerning you are being processed, and, where that is the case, all necessary information to make the process transparent;
  • Rectification:  you have the right to require rectification of inaccurate data about you;
  • Deletion of personal data: you have the right to request deletion of your personal data, but this right may be limited depending on the specific circumstances;
  • Object to processing: you have the right to object, on grounds relating to your particular situation, at any time to the processing of your data where we are relying on legitimate interest as legal basis;
  • Restriction to processing: you have the right to restrict processing of data under certain specified circumstances;
  • Data Portability: when you have given your consent for the processing of your data, you have the right to request to receive or transfer your personal data to another organization of your choice, in a machine-readable form;
  • Withdraw consent to data processing: when you have given your consent for the processing of your data, you can withdraw your consent at any time, without justification.

You can exercise your rights described above by contacting our Data Protection Officer at the following address: DPO@topalliancebio.com

If you would like to submit a complaint about our use of your personal information or our response to your requests regarding your personal information, you may contact us or submit a complaint to the Data Protection Authority in the member state of your habitual residence, of your place of work, or where an alleged infringement took place. If you are in the European Union, you can find your Data Protection Authority here. If you are in the UK, you can find the UK Data Protection Authority at here.

  1. Do we disclose information to third parties?

We may share information with TopAlliance EU affiliated companies and third party collaborators. 

In the event we are required to transfer personal data to recipients outside of the European Economic Area (EEA) or UK, it will protect the data in accordance with GDPR. If the personal data are transferred to countries that have not been recognized by the European Commission as providing an adequate level of data protection, we will put in place contractual safeguards to protect the data (e.g., EU Standard Contractual Clauses “SCCs” to the extent it constitutes a valid mechanism of transfer under Chapter V of GDPR).

  1. Amendment of the Privacy Notice

We reserve the right to change the Privacy Notice at any time. The changes will be posted on the website. If we make material changes to this Privacy Notice, we will notify you by updating the date of this Privacy Notice and posting it on our website. 

This Privacy Notice was last updated on April [02], 2026.

  1. How to contact us?

If you have any questions about this Privacy Notice or if you would like to register a complaint, please contact us by sending an e-mail to DPO@topalliancebio.com