Compliance

As a key player in the protection of patient health, we are committed to implementing the most honest, legal and ethical practices to ensure excellence in the quality of our services and processes, as well as regulatory compliance and adherence to international standards.

DEFENDING ETHICAL VALUES

Our position as a manufacturer of medicines and as a player in the protection and improvement of health, our expertise in the safety of medicines and our international activity impose that we always act in accordance with legal requirements, implementing high standards of integrity and ethics through our Ethics and Compliance Programme, and to behave as a socially responsible company.

Our staff can sometimes find themselves in confusing situations in the course of their work. Our code of ethics was developed to set up rules of conduct and integrity which constitute a necessary reference for each of us, to help us make the right decisions, at the right time, in an increasingly complex professional environment.

Code of ethics

ABL’s solid reputation is based on values passed on from one generation to the next.

The purpose of this Code is to establish the principles of compliance and ethics that apply to the company and to individual officers, directors, employees, customers and contractors such as suppliers, service providers.

Sharing your concerns

ABL is strongly committed to fighting against all unethical behaviours, corrupt practices, fraud, collusion, and discrimination.

Employees having concerns or doubts regarding any behaviour that may violate the code are encouraged and required to address their concerns to their director, manager, Human Resources Department or any member of the Leadership Team.

A professional whistle-blower hotline is available 24 hours a day for this purpose.

Inappropriate behaviour can be reported online using our alert platforms:

For ABL Europe: ableurope.alertcenter-ikarian.eu

For ABL Biomanufacturing: ablbiomanufacturing.alertcenter-ikarian.eu

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ENHANCING THE RELATIONSHIP WITH OUR THIRD PARTIES

Prevention of corruption

ABL is committed to fight against corruption on a daily basis, both internally and in relation with third parties.

ABL is committed to establish long-term relationships with its suppliers and service providers, based on a responsible purchasing policy, to ensure mutual success.

In addition to the Code of Ethics, ABL also established high standards of ethics and integrity for our business partners and suppliers through:

  • a business integrity guide “Business Practices for Third Parties”,
  • a process for selecting and monitoring third party intermediaries, including a questionnaire, the Third Party Approval Form.

In addition, training and information is provided to employees working with health authorities, suppliers, providers and public or private customers.

Business Practice Document and Level 1 Third Party Forms, FOR0334 and FORM004

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PROTECTING PERSONAL DATA AND ENSURING PRIVACY

ABL implements a strict confidentiality and security policy aimed at protecting the personal data it processes, and deploys an appropriate training programme to raise awareness of the staff on these regulations.

Protection of personal data and commitments to confidentiality and security

This personal data protection charter (the “Charter”) applies to ABL Europe, whose registered office is located in Illkirch-Graffenstaden (67400), France, as well as to ABL Biomanufacturing, whose registered office is located in Lyon (69002) (hereinafter collectively referred to as “ABL”, “we”, “us” or “our”, or “ABL group”, or “Institut Mérieux Group”).

In the context of this Charter, your personal information is referred to as personal data (“Personal Data”). We may also sometimes refer collectively to the management, collection, protection and storage (“the Processing”) of your Personal Data.

This Policy also includes information regarding sharing your Personal Data within the ABL group, the Institut Mérieux group and with third parties (such as our service providers, for example).

We have set up this Charter so that you can communicate your Personal Data in compliance with a strict confidentiality and security policy by which we undertake to protect your private life and to manage your Personal Data in a fair and transparent manner. For this purpose and in order to ensure the proper application of ABL’s commitments in terms of personal data protection, ABL appointed a data protection officer, in accordance with the applicable regulations, who can be contacted at the following addresses:

For ABL Europe: ableurope.alertcenter-ikarian.eu

For ABL Biomanufacturing: ablbiomanufacturing.alertcenter-ikarian.eu

Categories of Personal Data collected

We may collect or obtain such Personal Data because you have provided it to us (for example, through a contact form on our website), or through communication by third parties (for example, your employer or third-party service providers that we use for our business purposes) or because such Personal Data is publicly available.

We may also collect or obtain Personal Data about you by noting or deriving such data from the way you interact with us directly or indirectly through other persons (for example, partners, co-controllers or subcontractors, who may be involved in data collection operations on behalf of ABL).

The Personal Data we collect or obtain may include: first name, last name, email address. In some cases we may also collect other specific categories of Personal Data about you either with your prior explicit consent, or under contract, or if we are required to do so by law.

Nature and purpose of the Processing

We will use your Personal Data to inform you about the services we offer and the management of ABL’s activities.

If you no longer wish to receive commercial solicitations from us, you may say so by sending a request on the alert platform using the following addresses:

For ABL Europe: ableurope.alertcenter-ikarian.eu

For ABL Biomanufacturing: ablbiomanufacturing.alertcenter-ikarian.eu

Recipients of the Personal Data

In the context of one or more of the above-mentioned Processing purposes, we may communicate certain information to the ABL group, the Institut Mérieux group and/or to our suppliers/service providers or those of the Institut Mérieux group.

We may also be required to disclose your Personal Data in the event that such disclosure is required by law, an administrative authority or for the purposes of legal proceedings.

Protection of Personal Data

ABL takes all necessary precautions, including administrative, technical, organisational, and physical measures, to protect the Personal Data of employees, customers and partners against loss, theft and fraudulent removal, as well as against unauthorised access, disclosure, alteration or destruction of Personal Data.

Although we apply all security measures deemed reasonably necessary once your Personal Information has been collected, the transmission of data over the Internet (including by e-mail) is never completely secure. We strive to protect the Personal Information in our possession, but we cannot guarantee the security of the communication of data transmitted by us or to us.

Principles applicable to the Processing of Personal Data

ABL endeavours to ensure that the Personal Data in its possession is:

  • Collected for specified, explicit and legitimate purposes and not further processed in ways incompatible with those purposes;
  • Processed fairly and in accordance with the law, in full transparency to the data subject (individuals);
  • Adequate, relevant and limited to what is necessary for the purposes for which they are processed (data minimisation);
  • Accurate and, where necessary, kept up to date;
  • Kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which they are processed;
  • Processed in such a way as to ensure appropriate security;
  • Transferred from one country to another only subject to (i) an adequacy finding by the European Commission or (ii) appropriate safeguard measures.

Protection of children’s privacy:

ABL understands the importance of protecting the privacy of children, especially in a digital environment. As such, our site(s) is (are) not intentionally designed for or directed at children under the age of 16. It is our policy never to knowingly collect or maintain information about anyone under the age of 16.

Retention Period:

We will retain your Personal Data in our systems for the longest of the following: (i) the period necessary for the activity or operations; (ii) any retention period imposed by law; (iii) the end of the applicable statute of limitations period following any litigation or investigation that may arise in connection with the activity or services concerned, unless a prior request for deletion is sent to the ethical platform. At the end of this period, your Personal Data will be destroyed, in accordance with the applicable regulations.

Rights of Individuals:

In accordance with the laws and regulations relating to the protection of personal data, any individual  is entitled to exercise the following rights with ABL, who carries out processing of their Personal Data:

  • To be informed of the existence and purposes of any processing of his/her Personal Data;
  • To access his/her Personal Data and to request the rectification or deletion of his/her Personal Data or a limitation of the Processing;
  • To object to the Processing and to request the portability of his/her Personal Data;
  • To withdraw, at any time, his/her consent given to ABL;
  • To promptly inform the data protection officer of any loss or fraudulent removal (unlawful processing) of his/her Personal Data.

In order to exercise any of your rights, you may log on to the platform at the following email addresses:

For ABL Europe: ableurope.alertcenter-ikarian.eu

For ABL Biomanufacturing: ablbiomanufacturing.alertcenter-ikarian.eu

You can also use this contact address for any complaints about your privacy.

Right to complain:

If you are dissatisfied with the way in which we have handled your Personal Data or if there are any questions or requests unanswered by our services, you have the right to file a complaint by the relevant Administrative Authority for Personal Data Protection.

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ENSURING THE QUALITY OF OUR SERVICES

The performance of our quality management systems, backed by an ambitious Quality Policy, enables us to provide our customers with products that meet the strictest regulatory standards.

This is achieved through compliance with good manufacturing practices, the deployment of a demanding quality manual that lives on through all our employees, and the sharing of a common quality culture across all our sites.

GMP certificates, quality manual

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ABL Incorporation’s Compliance and Ethics Policy

If you have any questions or are looking for information about our parent company ABL Incorporation, please visit their website: ABL Home – ABL, Inc.