Code of Conduct EN - Home - BioNTech · trade secrets and intellectual property For research...

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CODE OF CONDUCT

Transcript of Code of Conduct EN - Home - BioNTech · trade secrets and intellectual property For research...

Page 1: Code of Conduct EN - Home - BioNTech · trade secrets and intellectual property For research companies like BioNTech, protecting confidential in- formation and intellectual property

Code of ConduCt

Page 2: Code of Conduct EN - Home - BioNTech · trade secrets and intellectual property For research companies like BioNTech, protecting confidential in- formation and intellectual property

IntroductIon by the ManageMent board

reSPect For the IndIVIduaL

Human rights and fair treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Commitment to our staff . . . . . . 10

Health and safety . . . . . . . . . . . . . . . . 11

conFIdentIaLIty and ProtectIng SenSItIVe data

Data protection . . . . . . . . . . . . . . . . . . 15

trade secrets and intellectual property . . . . . . . . . . . . 17

buSIneSS IntegrIty

Fair competition . . . . . . . . . . . . . . . . . . 21

Integrity in marketing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

treatment of clinical trial patients . . . . . . . . . . . . . . . . . . . . . . 22

Anti-corruption and gifts and donations policy . . . . . . . . . . . 24

Separation of personal and business interests . . . . . . . . . . . . . . . . 26

Communications with the public . . . . . . . . . . . . . . . . . . . . . . . . . 27

Scope and application . . . . . . . . . . 27

Rules for compliance . . . . . . . . . . . 28

Information about violations ......29

SuMMary

In brief . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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In conjunction with our objectives and our mission and vision, this Code of Conduct forms the framework within which we operate. It is intended to support each of our staff members in understanding the values and ethical principles of our company and putting them into practice.

As a research-driven biotechnology company, we set out to achieve both scientific and commercial success. In doing so, we are guided by a very clear vision — to bring highly effective, individualized, and innovative therapies to market and make them available to numerous patients around the globe. Our ongoing aim is to turn this vision into reality.

In our efforts to achieve this, full legal compliance and a strong sense of ethical responsibility underpin everything we do. Behav-ing with integrity is non-negotiable for BioNTech.

IntroductIon by the ManageMent boardThe BioNTech Group* develops, produces, and distributes highly innovative biopharmaceuticals and biomarker-based diagnostics for individualized treatment of cancer and other serious diseases. Responsible and lawful conduct is a fundamental prerequisite of this activity — whether in the laboratory, when dealing with staff members and business associates, or in contact with doctors and patients.

This Code of Conduct consists of principles and regulations that serve as a yardstick for our own performance and help us make de-cisions in our daily work. It sets out guidelines for interacting with staff, business partners, and third parties, and reflects the culture and standards of BioNTech.

* BioNTech AG and its affiliates (including their affiliates)

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We call on each of our staff members and partners to apply this mindset to their own acti viti es on a daily basis.

The BioNTech Management Board

Prof. Dr. Ugur Sahin - CEO Prof. Dr. Ugur Sahin - CEO

Dr. Sierk Poetti ng - CFO

Sean Marett - COO

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reSPect For the IndIVIduaLHuman rights and fair treatment

We respect and value the personal dignity of every individual. We are absolutely opposed to discrimination, especially based on gen-der, disability, religion or ideology, ethnic origin, sexual orienta-tion, or age. Rather, our actions are shaped by generally accepted ethical standards and principles, such as the Universal Declaration of Human Rights and the Fundamental Principles defined by the International Labor Organization (ILO). These govern aspects such as freedom of association, the elimination of forced, compulsory, and child labor, equal opportunities for all staff, and a safe working environment.

Along with any kind of discrimination, harassment will not be tol-erated at BioNTech. Every staff member has the right to be treated respectfully, fairly, and politely by their coworkers, managers, and business partners.

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Commitment to our staff

our employees are our greatest asset and the key to our success. Their knowledge and commitment determine the quality of our work. We thus strive to maintain an environment in which every staff member can feel confident of fair and respectful treatment, ensuring equal opportunities from hiring through professional de-velopment to pay.

Particularly given our company history, we are keenly aware that differing cultures and perspectives enrich our business. According-ly, we are always eager to embrace diversity as a valuable aspect of our company culture — stretching across gender, age, and cultural background.

Health and safety

Our business operations depend on the safety of our staff, our re-search, and our products. Ensuring a safe environment and appro-priate working conditions for our employees is a key element of our company policy. Our efforts to avoid accidents or damage include general safety instructions and supplementary training. In addition to compulsory medical examinations and required vaccinations for laboratory staff, we offer voluntary screening options. These are designed to enable prevention or early detection of visual distur-bances, eye diseases, musculoskeletal symptoms and conditions, or neurological disorders, for instance.

The scientific and technical conditions in our laboratories are checked and monitored by experts as a matter of course, to rule out any biological, chemical, or physical risks or hazards.

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We comply with applicable legislation such as the German Biolog-ical Agents Ordinance (BioStoffV) and the Genetic Engineering Act (GenTG), which regulates biotechnology companies conducting research with genetically modified material. Depending on the re-quirements, our labs are designated biosafety level (BSL) 2 or GSL 2.

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conFIdentIaLIty and ProtectIng SenSItIVe dataData protection

As a biotechnology company, maintaining the confidentiality of personal information about staff members, contract partners, trial participants, and applicants is essential. We observe the relevant provisions of Germany’s Federal Data Protection Act (BDSG) and Telemedia Act (TMG) as a matter of course, as well as other data protection policies. We grant the individuals affected access to the data we hold in relation to them, free of charge and without any need to specify reasons.

We use any personal information we collect solely for its intended purpose and store it only for as long as necessary. We take very seri-ously the rights of access, cancellation, and objection by the individ-uals concerned and will readily block, amend, or delete their data on receipt of the relevant application and as guaranteed by law.

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trade secrets and intellectual property

For research companies like BioNTech, protecting confidential in-formation and intellectual property such as patents, written mate-rial, software, know-how, and trademarks is exceptionally import-ant. Interference and unauthorized access by third parties must be prevented.

Proprietary and confidential information consists of anything that is not publicly accessible but could be of significant value to BioNTech or third parties, particularly competitors. This includes lab books, financial data, scientific research, production processes, investment plans, employee information, and so on.

Our employees are trained to treat this sensitive information care-fully, with an internal security guideline setting out all the details. If there is any doubt, staff should consult the Intellectual Property (IP) and Legal departments. All new employees must read a docu-ment when joining the company that commits them to safeguard-ing trade secrets and confidential data.

In addition to compliance with established data protection laws, we actively counteract the dissemination of personal data by en-suring our employees receive comprehensive training. All staff and service providers engaged by BioNTech are contractually obliged to maintain confidentiality and adhere to the data protection re-quirements.

BioNTech’s Data Protection Officer is always available for any ques-tions in this area.

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In some cases, sharing certain information with an external partner is unavoidable. However, this should only take place on approval by the relevant line manager and once a confidential disclosure agreement (CDA) has been signed. In case of any uncertainty, the Legal or IP departments will again be glad to advise.

Needless to say, we equally respect the confidential information and intellectual property of other organizations and thus also pro-hibit the unauthorized use of external material. It is expressly for-bidden to use copyrighted material without permission from the originator.

Direct or indirect use of confidential business information for per-sonal gain or to benefit third parties is also prohibited.

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buSIneSS IntegrItyFair competition

Our intention is to achieve market success due to the quality and exclusivity of our research. We view free and fair competition and the principles of the market economy as fundamental to the way we do business. We thus expect every staff member to adhere to the rules of fair competition. This includes avoiding any unfair or, especially, unlawful treatment of competitors and not making any ambiguous statements about them. We also refrain from dissemi-nating negative reports about our competitors.

Any unlawful price-fixing or illegal agreement to restrict compe-tition is prohibited. This also applies to suppliers. We evaluate their proposals objectively and make our selection based on the price-performance ratio.

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Integrity in marketing activities

We market and distribute our products in compliance with the ap-plicable legal requirements, on the basis of quality, efficacy, and safety, and in accordance with high ethical standards. This commit-ment also applies to all other activities that support the marketing of products, including gathering and disclosing medical and other information.

Treatment of clinical trial patients

The protection and wellbeing of patients or participants in clinical trials is of paramount importance. We are therefore committed to the core international principles for clinical trials as set out in the Good Clinical Practice (GCP) Guideline and the Declaration of Helsinki, which define ethical principles for medical research in humans.

Clinical trials are always conducted by external trial centers ap-plying high medical standards. BioNTech exerts no influence on decisions about admitting individual patients to specific trials. This is decided solely by the clinical investigators in accordance with the inclusion and exclusion criteria laid down in the trial pro-tocol and, above all, on the basis of the risk-benefit assessment for each patient concerned.

Patient details are, of course, covered by the same strict data pro-tection principles that apply to BioNTech staff members (see page 15).

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Anti-corruption and gifts and donations policy

Business relations often also entail social contact and trust-based interaction between partners. Our commitment remains to act with integrity in every situation. We actively uphold the United Nations Convention against Corruption (UNCAC) of 2005, and thus reject all forms of corruption. Instead, we foster integrity, transpar-ency, and responsible leadership.

We do not offer our business associates gifts or other benefits, whether direct or indirect, that could interfere with fair and impar-tial decision-making within their organization — even where there might be some “cultural expectation” to do so. The same applies in reverse to BioNTech staff. In principle, we do not accept gifts or invitations from business associates, partners, suppliers, compet-itors, or other third parties. Exceptions may only be permitted in individual cases where the gift does not exceed customary limits, is not associated with any claim or entitlement, and has no influence on business decisions. Accepting monetary gifts is not permitted,

even in isolated cases. The BioNTech gifts policy addresses this area in more detail.

Particular care must be taken in this regard when dealing with public representatives, such as civil servants, and with government officials. Alongside regional and national government employees, this specifically also applies to officials of international organiza-tions such as the UN, EU, or WHO.

BioNTech has no political affiliation and therefore does not make donations to political parties. In general, donations may only be made to organizations in a position to ensure that they are tax-de-ductible. Donations are made on a purely voluntary basis and without any ensuing expectation. As a matter of principle, every donation must be approved by at least two members of the Man-agement Board. Further details are set out in the BioNTech dona-tions and sponsorship policy.

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Separation of personal and business interests

At BioNTech, business decisions are made on an honest and objec-tive basis. Situations sometimes arise in which the personal inter-ests of a staff member run counter to the interests of the employer. At BioNTech, such conflicts of interest must be avoided in order to ensure business decisions remain impartial at all times.

The term “personal interests” applies not only to staff members themselves but also to those close to them. Family ties between employees and partners of BioNTech must therefore be disclosed and BioNTech’s interests are not to be compromised.

Communications with the public

Permission to give official statements on behalf of BioNTech or en-ter into active communication with the public and selected me-dia representatives is limited to specific parties. These include the Management Board, Supervisory Board, specifically designated staff members, and representatives of the Corporate Communica-tions department. To ensure communication remains consistent at all times, employees are not permitted to provide information in-dependently on behalf of BioNTech.

Scope and application

This Code of Conduct applies to every staff member in every business area across all our sites. This includes our affiliates. Internal princi-ples, guidelines, and standard operating procedures may also set out BioNTech’s requirements in more detail. These regulations supple-ment the Code of Conduct and must not conflict with it. Equally, the Code of Conduct is not to be circumvented by individual instructions.

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Rules for compliance

Every staff member is obliged to adhere to this Code of Conduct while going about their work. If there is any uncertainty about any of the principles, staff members should seek advice from their line managers. Alongside the Code of Conduct, staff must be familiar with all other relevant BioNTech policies and inform themselves in this regard as required.

All our managers have a particular role to play in terms of providing information and setting an example. It is their duty to familiarize their staff with the Code’s requirements and, especially, to exem-plify socially and ethically correct behavior in line with the princi-ples of this Code.

the Code of Conduct should be incorporated into the daily busi-ness activities of every staff member and encourage reflection and discussion. As a living document, this Code will continue to evolve.

Information about violations

Responsibility for BioNTech’s reputation is shared by every staff member. Violations of this Code of Conduct should be report-ed to the Compliance Officer. The confidentiality of this process is assured. A zero-tolerance policy applies to violations and legal infringements. Breaches of the law will incur legal consequences, which may include criminal prosecution.

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In brIeF Our Code of Conduct explains how integrity shapes our day-to-day business routines and what is expected of us as a responsible company. We each have a duty to apply these principles to our own activities.

that means:

Reading the Code of Conduct carefully and asking if anything is unclear

Incorporating its requirements into our own everyday business practices

Observing all legal or established standards and regulations

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BioNTech AGAn der Goldgrube 1255131 Mainz GermanyPhone: +49 6131 – 9084 – 0Fax: +49 6131 – 9084 – 390email: [email protected]

www.biontech.de