CoC Pharmacosmos_Doc UK

Co Pharmacosmos Code of Conduct

Contents

Introduction

Introduction ............................................................................................................................ 3 Scope ...................................................................................................................................... 4 Roles and Responsibilities ....................................................................................................... 4 Compliance .............................................................................................................................. 5 Raising concerns about misconduct ........................................................................................ 5

Dear Pharmacosmos employees

Pharmacosmos Standards Quality..................................................................................................................................... 6 Manufacturing and Operations .......................................................................................... 6 Distribution ........................................................................................................................ 6 Security in the Supply Chain ............................................................................................. 6 Labour Rights ........................................................................................................................ 7 Equal Opportunities ........................................................................................................... 7 Rights at Work................................................................................................................... 7 Child Labour and Young Workers ..................................................................................... 7 Forced Labour ................................................................................................................... 7 Health, Safety and Environment........................................................................................... 9 Health and Safety.............................................................................................................. 9 The Environment ............................................................................................................... 9 Animal Welfare .................................................................................................................. 9 Anti-Bribery .......................................................................................................................... 10 Bribery and Corruption .................................................................................................... 10 Gifts and hospitality ......................................................................................................... 10 Facilitation Payments ...................................................................................................... 10 Political Donations, Charitable Contributions and Sponsorships .................................... 10 Conflicts of interest.................................................................................................................... 10 Books and Record Keeping ............................................................................................ 11 Anti-money Laundering ................................................................................................... 11 Fair Competition, International Sanctions and Export Control ...................................... 12 Fair Competition .............................................................................................................. 12 International Sanctions and Export Control .................................................................... 12 Business Ethics in our Interactions ................................................................................... 13 Public Officials ........................................................................................................................... 13 Health Care Professionals............................................................................................... 13 Patients and Patients Organisations ............................................................................... 13 Business Partners ........................................................................................................... 13 Product Communication .................................................................................................. 13 Data Privacy and Information Protection .......................................................................... 14 Company Assets, Intellectual Property and Confidential information ................................ 14 Data Protection and Privacy............................................................................................ 14

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Our values and aspirations describe who we are and where we want to go.

With this Code of Conduct, built on our company’s values, we set our commitment to live these values and achieve our aspirations by conducting our business ethically and with integrity towards • • • •

Our employees, Patients, health care professionals and customers Business partners, and The community and the environment.

In doing so, we have been inspired by the UN Global Compact’s ten fundamental principles within the areas of human rights, labour rights, the environment and anti-corruption, principles which Pharmacosmos is committed to implement as part of our core operations.

The Code of Conduct also sets out our clear expectations to you, our employees, to not compromise on quality or business ethics and it provides standards and guidance for when you make decisions and take actions, even when confronted with difficult situations.

We thank you for your commitment to our Code of Conduct and taking on the responsibility to comply with it. Our combined efforts in ensuring adherence to our Code of Conduct will enable us to deliver sustainable growth, as well as being proud of both our individual actions, and of being a part of Pharmacosmos.

Sincerely Tobias S Christensen President and CEO, MD.

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Scope This Code of Conduct applies to and must be followed by all persons working for Pharmacosmos companies globally, or on our behalf, in any capacity. Specific global and local policies and procedures may further apply to your conduct.

Roles and Responsibilities

Compliance This Code of Conduct is an ethical compass reminding each employee of his or her legal and ethical obligations.

Employees • Read this Code of Conduct, and apply it in your daily work • Communicate the Code of Conduct’s quality, ethics and compliance standards • Seek advice when in doubt and report concerns about misconduct

No written policy can exhaustively account for all business situations, and if you are uncertain about how to proceed in a situation you should ask yourself the following questions: • • • •

Am I compromising my own personal ethics?

Would my colleagues, family and friends think that my conduct was ethical?

Would I be comfortable, if my conduct appeared in the media?

Will my conduct allow Pharmacosmos to maintain the trust of our customers, partners and patients?

If you are unsure how the Code of Conduct’s standards apply, seek guidance from your local legal or compliance function.

Managers Be a role model and act ethically, always • Demonstrate that for results to matter, they must be achieved by following the Code of Conduct’s quality, ethics and compliance standards • Guide the employees reporting to you on how to carry out their daily work in compliance with the Code of Conduct • Promote a responsible, ethical culture

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The Code of Conduct forms an integral part of the terms of employment of all Pharmacosmos employees. Failure to comply with the provisions of the Code of Conduct may result in serious damage to Pharmacosmos’s reputation and business interests and violations by employees may result in disciplinary action.

You will find policies and procedures in Pharmacosmos’s Quality and Compliance Management System within the different areas that are covered by the Code of Conduct.

Raising concerns about misconduct We encourage you to report any suspected or actual misconduct or violations of the Pharmacosmos Code of Conduct through the channel that you feel most comfortable with, including through the channel(s) specifically set out for reporting of concerns about potential or actual misconduct or violations relating to business ethics compliance in Pharmacosmos.

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Pharmacosmos Standards

Labour Rights

Quality

Equal Opportunities

Manufacturing and Operations Pharmacosmos is committed to ensuring highest quality of our manufacturing and operations that meet all the necessary regulatory requirements to protect the safety of patients and animals.

We adhere to all requirements for reporting of adverse events.

We adhere to applicable laws and regulations relating to manufacturing and require the same from our suppliers and sub-contractors.

Pharmacosmos’ medicinal products and active pharmaceutical ingredients (API) comply, as a general rule, with EU cGMP. The facility and systems of Pharmacosmos are regularly inspected by national and international health authorities [including the Danish Medicines Agency and the United States Food & Drug Administration (US FDA).]

Distribution Pharmacosmos undertakes distribution in accordance with Good Distribution Practices (GDP).

We require our distributors to ensure that any form of tampering, contamination, damage etc. is immediately reported to Pharmacosmos.

Security in the Supply Chain To guarantee security in the supply chain, Pharmacosmos has introduced measures to protect goods and services against unauthorized access during production, storage, handling and processing and employs reliable personnel performing these functions. We inform and require the same from our contractors.

Pharmacosmos believes that diversity and inclusion are key to its global success.

We promote equal opportunities for all employees and provide an inclusive work environment, where everyone regardless of age, gender, gender identity, sexual orientation, colour, race, disability, religion, belief, nationality, social status or any other status recognised by international law is treated with respect.

We do not tolerate any form of discrimination and harassment in the workplace and expect that each and every employee treats colleagues, customers, partners and patients with respect.

We do not tolerate the use of offensive language and gestures.

Rights at Work Pharmacosmos respects employees’ rights at work.

We respect our employees’ right to freedom of association and recognise their right to be a member of a union or other collective bargaining group.

We compensate our employees with fair pay for their work, as well as reasonable work breaks and paid holidays in accordance with local law.

Child Labour and Young Workers Pharmacosmos never employs child labour, either directly or through subcontractors or other business partners.

Unless stricter national laws apply, the minimum age for employees is 15 years.

In rare cases, and if national law permits, children under the age of 15 years are allowed to carry out light work that does not interfere with the children’s schooling.

Young workers under the age of 18, are not allowed to work during night and should not work with dangerous goods or hazardous substances.

Forced Labour Pharmacosmos does not engage in human trafficking.

We allow our employees freedom of movement during their employment. Personal documentation such as passports and/or payment of compensation are not retained or withheld to prevent such freedom of movement, thereby giving rise to forced or involuntary labour.

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Health, Safety and Environment

At Pharmacosmos, we care about the environment and support the protection of the environment through meaningful action.

Health and Safety At Pharmacosmos, health and safety in our workplaces is a priority.

We take responsibility to follow applicable safety rules and regulations to provide a safe and healthy work environment, and strive to promote an accident-free workplace.

We promote a culture where employees take personal responsibility for their own safety and the safety of their colleagues and we provide training and educate employees in health and safety issues.

We inspire our employees to constantly challenge and suggest improvements to our working practices.

We employ an occupational health & safety management system and implement specific guidelines, including safe work procedures and training specific to the handling of dangerous goods and hazardous substances and emergency plans.

The Environment We comply with applicable environmental legislation.

We strive to identify those areas that have the most significant environmental impact and continuously look for improvements in the areas of waste reduction, minimisation of energy consumption and recycling.

Animal Welfare Pharmacosmos believes that animals shall be treated respectfully, with pain and stress minimised.

We comply with applicable local laws and regulations relating to such.

Whenever we undertake trials which involve animals or breed and supply animals for use in studies, we treat animals humanely with greatest consideration given to their health and welfare and consistent with meeting the scientific objectives. In studies, we always consider whether animals can be replaced, the number of animals reduced, and procedures refined to minimise distress.

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Anti-Bribery Bribery and Corruption

Books and Record Keeping

We are committed to honest and fair business dealings, free from bribery, corruption, extortion or fraud.

We ensure the integrity of our business transactions by maintaining accurate and complete books and accounting records.

Bribery is illegal and the consequences are substantial. The reputation of Pharmacosmos could be damaged by irresponsible actions and employees could face criminal prosecution.

We comply with all relevant laws and regulations, and reporting and accounting guidelines in respect of your business at all times.

At Pharmacosmos, we actively work to conduct business in a fair, transparent and legal manner and not engage in bribery in any form.

Records like invoices, employee expenses and any transfer of value should reflect the nature of the business purpose, the transaction, be truthful, complete and unaltered.

We do not offer, give, request or receive bribes, nor engage in improper payments or corrupt practices.

Anti-money Laundering

Gifts and hospitality We never give or offer anything of value to seek improper influence. We follow the strict legislation and standards that applies to gifts and hospitality in the healthcare industry and towards public officials.

Pharmacosmos does not engage in or accept any involvement with money laundering.

We work actively to minimise the risk of being involved in such practices and we require likewise our business partners to have proper internal control systems to minimise their risk.

Where gifts and hospitality are not prohibited or restricted, we only offer, give and accept gifts and hospitality which are reasonable in scope, value and frequency, and which reflect ordinary local business customs.

Facilitation Payments We actively oppose demands for facilitation payments made by any public official.

Facilitation payments are small but illegal payments (or other benefits) made to government officials to speed up services to which you are entitled to, but for which you are not given an official receipt.

Political Donations, Charitable Contributions and Sponsorships At Pharmacosmos, we avoid supporting any political organisations, and we never use charitable or commercial sponsorships with a view to gaining an unfair advantage to improperly influence decision-making in connection with any transaction with Pharmacosmos.

Conflicts of interest At Pharmacosmos, business is conducted in a professional and objective manner and decisions must not be improperly influenced by our personal, social, financial or political interests.

We expect mutual transparency in business decisions and transactions to prevent the possibility of conflicts of interest arising. This means being transparent about the involvement of any employee or a close relative of such which is directly involved or has a substantial economic interest in the business of a partner with whom we have a business relationship.

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Fair Competition, International Sanctions and Export Control Fair Competition Pharmacosmos is committed to the principle of fair, open and unrestricted competition, and we conduct our business in a fair and legal way.

We comply with all applicable competition and antitrust laws and we do not engage in anticompetitive practices, such as illegal price-fixing and sharing, market sharing, output limitation, bid-rigging, etc.

International Sanctions and Export Control Pharmacosmos complies with applicable international sanctions and export control restrictions imposed or introduced from time to time and adopts appropriate measures to implement such compliance in practice.

Business Ethics in our Interactions Public Officials We interact with public officials, ethically and transparently and we do not give or offer anything of value to seek improper influence.

We recognize that interactions with public officials are subject to strict international laws and local rules and we take into account and comply with any applicable restrictions in conducting our activities.

A public official is any public or civil servant, official or representative of public authority, government, state, state owned entity, political party, or an international public organization.

Health Care Professionals We believe that interactions with health care professionals and Healthcare organisations are in the interest of patient safety, the quality of patient treatment and innovation.

We are committed to comply with applicable laws and regulations in every aspect of our relationship with health care professionals.

We never give or offer anything of value to improperly influence their prescribing or purchasing decisions and we comply with applicable transparency reporting regulations.

Pricing concessions, discounts, free goods, or rebates are only provided to the extent compliant with local laws and regulations.

Patients and Patient Organisations We are committed to doing what is best for patients.

We comply with applicable local and international laws governing our interactions with patients and patient organisations.

Business Partners We only engage with reputable, honest and competent business partners.

Working with business partners is an important factor for achieving our goals to develop and supply our products in many corners of the world. Our business partners need to understand and respect our values and the principles in the Pharmacosmos Business Partner Code, and we work actively to ensure that this is the case.

We work actively to evaluate our business partners’ integrity, reputation and compliance with laws. We never use business partners to disguise illegal transactions.

We maintain accounts and records that properly and on a timely basis, reflect all transactions accurately, detailing the nature of goods and services provided or received.

Product Communication We communicate to health care professionals about our products to support their informed use so they are able to make the best treatment choices for the benefit of the patient’s health.

We promote our products in a manner that is truthful, accurate, non-misleading, fairly balanced and consistent with the applicable rules on promotion of medicinal products.

We are committed to ensuring that information provided to government agencies is truthful, accurate and non-misleading.

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Data Privacy and Information Protection Company Assets, Intellectual Property and Confidential information We safeguard Pharmacosmos assets, intellectual property rights and confidential information, all of which are of immense value to Pharmacosmos.

We exercise due care and attention and do not disclose any confidential information of Pharmacosmos or its partners to unauthorised third parties.

We comply with relevant laws regarding intellectual property rights and never knowingly infringe the intellectual property of Pharmacosmos or others.

Data Protection and Privacy Pharmacosmos is committed to comply with applicable data protection/privacy laws.

We strive to provide adequate personal data and information security protection for the information that we collect and process from our employees, health care professionals, patients and partners.

We operate in a manner that is consistent with applicable data protection/privacy laws and aligned with industry standards for the protection and security of all information, including personal information.

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