Code of Conduct and Business Principles

INTRODUCTION

This Code of Conduct and Business Principles serves as a foundation for the ethical and responsible behavior expected of all Esperante Development representatives. By adhering to these principles, we can continue to build a company that is respected and trusted by all its stakeholders.

At Esperante Development B.V. (“Esperante” or the “Company”), we act with fairness, honesty and integrity with the patients at heart of our concern.

We are also committed to act in accordance with our values, which are Inspiring, Respectful, Reliable, take Ownership and Creative – IRROC (“Esperante Values”). The Esperante Values are also reflected in the way Esperante and its Employees conduct business in a socially responsible and ethical manner, and in line with the laws and regulations applicable in the countries in which Esperante is established or conducts its business and that apply to the Company’s operations and activities (“Applicable Laws”).

Building on its Values, the Company also expects all Employees to use good common sense and sound judgment and to be ethical in every decision or action they take.

As Health Care provider, we are committed to improving the health of people and to find new solutions for patients by blending science with advanced technology.

We work hard to offer a continuous supply of medicines and medical devices, while guaranteeing the safety and health of all our patients. Our common thread is to meet medical needs and be a reliable partner for health care professionals and our business partners.

Scope

This Code of Conduct (“the Code”) contains an overview of our business principles and guidelines for the resolution of ethical and legal issues that Employees may encounter in their work for the Company. Esperante expects each Employee, both permanent or temporary, as well as temporary employment agency workers, contractors and consultants, and members of the Board of Directors (each an “Employee” and collectively “Employees”) to familiarize themself with this Code and to comply with it.

Impact in case of non-compliance

In the event an Employee would not comply with this Code, this could lead to irreparable harm and loss of reputation for Esperante, and Esperante will consider disciplinary action including, in cases of gross negligence, possible dismissal.

Updates

These principles and guidelines are not intended to be a complete list of ethical and legal matters Employees may face in performing their tasks, but serve as guidance for Employees to abide by Applicable Laws and behave in a socially responsible and ethical manner. This Code is a living document, and will therefore be updated when so required, as the Company and the environment in which it operates, evolves. The principles and guidelines in this Code of Conduct (“Business Principles”) may, where desirable, be further embedded in policies and directives.

BUSINESS PRINCIPLES

 

Work Environment

Esperante is committed to ensure the well-being of Employees and to offer a safe and healthy work environment free from discrimination, violence and harassment and to respect the privacy of all Employees.

  1. Equal employment opportunity

Esperante treats all Employees equally and does not tolerate discrimination on the basis of race, nationality, religion or belief, political affiliation, gender, sexual preference, age, disability or any other basis whatsoever. This should be reflected in recruitment, hiring, training and promotion and the Company’s terms and conditions of employment. Esperante offers equal opportunities to all Employees and job applicants based on qualifications, experience, achievements and performance in an objective and fair manner.

  1. Fair employment terms

Esperante offers Employees a fair remuneration and fair terms and conditions of employment, including relating to work hours, wages and benefits, in line with industry standards. Esperante offers Employees equal pay for equal work.

Esperante respects the freedom of association and promotes diversity and inclusion.

  1. Protection against workplace violence and harassment

Esperante does not tolerate any disrespectful or abusive behavior or threats thereof nor any type of harassment (verbal, physical, visual or sexual) by or against Employees. Esperante is committed to maintain a workplace where Employees feel safe and free from intimidation, harassment, bullying, abuse, hostility or any other offensive behavior.

  1. Health and safety

Esperante offers Employees safe working conditions in line with Applicable Laws and industry standards to ensure that Employees can return home safely and in good health. The Company’s facilities must be safe and equipped in line with Applicable Laws relating to safe working conditions protecting both Employees and contractors. The Company’s facilities are organized in such a way as to prevent accidents or harmful incidents, as well as occupational diseases.

  1. Privacy

Esperante respects the privacy of Employees and is committed to processing personal data of present and past Employees as well as job applicants, in such a way as to protect personal data. Any systems processing personal data will be set up and operated in accordance with Applicable Laws and the Company’s privacy policy (“Esperante Privacy Policy”).

  1. Responsibility

While Employees should be committed to contribute to a safe and healthy work environment, it is the responsibility of the CEO, Management Team and every supervisory Employee to ensure a work environment and conditions are in line with these Business Principles.

 

Business Integrity, Social Responsibility and Legal Compliance

  1. Ethical conduct

7.1. Esperante expects Employees to maintain the highest standards of business and personal ethics in the performance of their tasks and responsibilities, both internally and towards other Employees, as well as externally towards business partners, including licensees, customers, agents and distributors, academic groups, suppliers, service providers, shareholders, hospitals, patients and clinical trial participants, health care professionals, governmental and regulatory authorities and other external stakeholders and relations.

Employees should at all times act in accordance with Applicable Laws and in a socially responsible and ethical manner. Employees should respect the values and local customs in countries where they conduct business, while at the same time maintain the Esperante Values and Business Principles. Esperante strives to be a responsible and respected partner in society. Esperante values its business relationships and expects Employees to conduct business based on trust with integrity, honesty and fairness and in line with these Business Principles.

7.2. Esperante does not tolerate any dishonest or fraudulent activities, such as theft of property, falsification of expenses or records, scientific misconduct or misrepresentation of any fact or circumstance, including without limitation the fabrication, falsification or plagiarism in proposing, conducting or reporting of (clinical) research data or any other data whatsoever.

  1. Conflicting Relationships

8.1. Employees should avoid conflicting relationships with persons, companies, firms, institutions, governmental and regulatory authorities, as well as other parties, with whom Esperante does or is likely to do business or which could affect the Company’s reputation or interfere with the fulfilment of the responsibilities of the Employee towards Esperante (“Conflict of Interest”). While avoiding a Conflict of Interest, Employees should avoid disclosure of Confidential Information as well as a conflict with the business interest of Esperante. Employees should disclose any such relationship of themselves, their spouse or other family members in the event and to the extent there is a risk that such a conflict of interest may arise.

8.2. If an Employee becomes aware of or suspects a Conflict of Interest, the Employee should without delay disclose such Conflict of Interest to the Company.

  1. Anti-bribery

9.1. Esperante deals with its business relations in a straightforward and transparent way without any undue influencing and in accordance with Applicable Laws. Esperante does not tolerate the payment or offer to pay or authorization or receipt, either directly or indirectly, of bribes. A bribe also includes a kick-back or any other payment or the grant of any gifts or other favors to any public official, government or other individual, to secure any decision, concession or business or obtain any approval, authorization, contract or any other advantage or favorable treatment for Esperante or an Employee. Esperante does also discourage payments to induce officials to perform routine functions.

9.2. Payments on behalf of Esperante should be made only on the basis of adequate supporting documentation, and may only be made for the purpose described in such documentation and must be made in accordance with the Company’s accounting procedures.

9.3. Employees may not accept and should report any payments, gifts and other advantages that may be offered to them by third parties that have or wish to enter into a business relationship with Esperante.

  1. Gifts and Hospitality

10.1. Esperante abides by Applicable Laws and industry regulations relating to the promotion of medicinal products to healthcare professionals, healthcare organizations and patient organizations. This means, without limitation, that Esperante will only organize and sponsor events and offer hospitality in accordance with such rules and that gifts are prohibited unless made in accordance with such rules. Also donations, grants and sponsorships for the benefit of healthcare organizations and healthcare professionals will only be made in accordance with such rules.

10.2. Esperante or its Employees may not accept or offer any gifts, meals or hospitality in return for a business favor. Any action or gift that could, in any way, inappropriately influence or pressure a person into making a business decision is not tolerated.

  1. Fair Competition

11.1. Esperante competes in the pharmaceutical market based on the science and quality of its services and products. Esperante strives to make a difference to the competition and thereby competes by offering high quality development services including innovation, and  continued supply of medicines and medical devices to meet customers, health care professionals and patients medical needs.

11.2. Esperante is committed to avoid any agreements, undertakings or practices that may prevent, restrict or distort competition. Employees should avoid any conduct that violates, or that might appear to violate, competition law; special attention should be given to arrangements in which exclusivity is granted or requested or in which production, markets, research and development or investments are being limited or controlled. Employees should seek legal guidance when entering into important collaborations. Esperante is equally committed to avoiding any conduct that may qualify as abuse of a dominant position.

11.3. More generally, Employees should abstain from and avoid any violation of national and supranational competition laws. Any activity in collaboration with competitors should be carefully scrutinized and may only be undertaken after confirmation by the legal counsel that the activity is lawful.

  1. Trade Sanctions

12.1. Esperante is committed to abide by any Applicable Laws relating to trade, economic or financial sanctions, embargoes or restrictive measures imposed, enacted or enforced by the Security Council of the United Nations, the USA, the UK, the European Union or any of its member states, or any other relevant country (or any governmental institute or agency of any of the above). This includes any country in which Esperante or any party (i) supplying or manufacturing any products or active substances or other components thereof, to or on behalf of Esperante, (ii) providing or developing technology to or for the benefit of Esperante, or (iii) representing Esperante or commercializing any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante, is established or conducts its business (“Applicable Trade Sanctions”).

12.2. Esperante expects its business partners, including licensees, customers, agents and distributors, scientific groups, suppliers and service providers, to equally comply with Applicable Trade Sanctions when providing goods or services to Esperante or selling products or commercializing any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante.

  1. Integrity of Books and Records

13.1. Esperante records and reports all data and information fairly, accurately, timely and clearly. This applies not only to financial records but also to other information relating to its operations, including but not limited to expenses, revenues, research results, clinical data, manufacturing and quality data, intellectual property, agreements, statutory records and other corporate information.

13.2. All reports, filings and submissions with governmental and regulatory authorities must be prepared with care and honesty and should be accurate and reliable at all times. All such reports, filings and submissions must be made in accordance with Applicable Laws.

13.3. Esperante strictly complies with the Company’s comprehensive system of internal accounting and control. All financial transactions and payments must be authorized and recorded. All assets, liabilities, revenues and expenses of Esperante must be properly entered in the Company’s books, records and all other financial documents Esperante keeps. These books and records must accurately reflect and properly describe the transactions that are being recorded and fairly present the state of affairs and business of the Company.

13.4. Esperante does not tolerate that (i) any undisclosed or unrecorded funds, assets, liability or account are established or (ii) false or artificial entries are made in its books and records.

13.5. All public disclosures by Esperante must be complete, fair, accurate and understandable and filed or published timely in accordance with Applicable Laws. Esperante communicates openly about its operations, without compromising Confidential Information.

  1. Anti-Money Laundering

14.1. Esperante is committed to complying fully with all the Applicable Laws relating to combating money laundering and any activity which facilitates the funding of terrorist or other criminal enterprises. Esperante will not engage in or facilitate any activity that might constitute, indicate or raise suspicions of money laundering. Esperante will also not enter into a transaction with a business partner, including licensees, customers, agents and distributors, academic groups, suppliers and services providers that is not duly organized and validly existing or of whom Esperante reasonably suspects it does not comply with Applicable Laws.

  1. Data Privacy

15.1. Esperante is committed to process personal data of identifiable natural persons, including not only Employees, as provided in Section 5 hereof, but also other natural persons,  especially patients and clinical trial participants, in such a way as to protect personal data in accordance with Applicable Laws, including but not limited to the General Data Protection Regulation (“GDPR”), as well as the standards and guidelines on the processing of personal data laid down in pharmaceutical legislation and regulations. Esperante attaches great importance to a careful balance between the responsibilities related to the development, manufacture and marketing of medicines on the one hand, and the protection of personal data on the other hand.

15.2. Esperante will only collect and process personal data to the extent necessary for a specific purpose and will assure that such data is and remains accurate, complete and up-to-date and in accordance with the Esperante Privacy Policy. Personal data will be protected by adequate security safeguards against such risks as loss or unauthorized access, destruction, use, modification or disclosure of data.

  1. Environmental Commitment

16.1. Esperante is committed to respect the environment and to observe all Applicable Laws relating to the protection of the environment. Esperante strives to minimize any negative impact of its business on the environment and attaches importance to durable innovative measures, relieving the pressure on the environment.

16.2. More specifically Esperante will use reasonable efforts and will encourage its Employees and business partners to use reasonable efforts:

(i)    to avoid waste by reducing, reusing and recycle goods used in its and their operations;

(ii)    to reduce pollution in its and their operations, including in research & development  and in the manufacture, distribution and transportation of products;

(iii)  to mitigate climate change by limiting energy consumption, using clean energy, or offsetting emissions with carbon credits.

  1. Quality, Safety and Pharmacovigilance

17.1. Esperante is committed to ensure patient safety through optimal regulatory compliance and quality of its products. The products of Esperante will be continuously monitored through collection and review of information regarding quality claims and adverse events in close partnership with Esperante’s customers and Health Authorities

17.2. Esperante manufactures, has manufactured, sells, supplies and distributes its products in compliance with Applicable Laws and in line with ethical standards and industry practices.

17.3. All services, products, materials and messages must be fully substantiated with reliable and proper data (including required certificates) and accompanied by applicable use, prescribing and safety information. All product claims must be consistent with country-specific approved labelling and prescribing information.

  1. Animal Welfare

18.1. Esperante is committed to the development and the use of validated testing methods that limit or avoid the use of animals whenever possible and permitted by regulatory requirements. Animal testing shall be performed only after consideration to Replace animal testing by alternatives, Reduce the numbers of animals used or Refine procedures to minimize distress, the 3 “R”, in accordance with global regulatory expectations.

18.2. In the event animals are required to be used to conduct research and/or quality control, Esperante uses its best efforts to safeguard the welfare of such animals and that they will be treated with respect, with minimal pain and stress, and in line with ethical standards, Applicable Laws and industry practices.

 

 

Use of Company Resources, Communications

  1. Access to and Use of Company Resources

19.1. Esperante provides Employees with access to company data, information and technical resources (including the internet) to perform their tasks and responsibilities, and to facilitate communication in connection with the business of Esperante. Such company resources should not be used for any other purpose or in a way that is detrimental to Esperante.

  1. Use of Internet, Social Media

20.1. Employees should use their Company’s email account for business purposes only and not for immoral or unethical purposes. Employees should be aware of the potential dangers inherent to the internet and use this resource sensibly and primarily for business purposes in line with any directives and guidelines that Esperante may impose regarding such use. Employees should respect and follow all security measures taken by Esperante to protect the Company’s data and information.

20.2. Esperante recognizes that many Employees are actively posting and sharing information on the internet or in social media. While we respect the right of Employees to engage in personal online activities, we expect Employees to behave responsibly and avoid any damage or harm to the Company. Employees should be aware of their position within and responsibility towards Esperante, especially when they disclose their affiliation with Esperante. Employees should especially not share confidential or non-public information relating to the Company or its services or products, discuss or promote products or make any statements on behalf of the Company or reflecting any opinions relating to the Company’s business in general without being authorized to do so.

  1. Confidential Information

21.1. Esperante is committed to maintain confidentiality of data and information, including inventions, models, information relating to products, formulations and processes, technologies, know-how, trade secrets, research programs, projects, business forecasts, plans, strategies, undisclosed financial data, cost prices, information concerning or relating to the Company’s business partners, business terms, personal data, safety & quality data, security data (including passwords) and any other information whatsoever, of which the (premature) disclosure could cause irreparable harm to the Company (“Confidential Information”). Confidential information may also include information received from other companies or individuals in the course of the Company’s business.

21.2. Employees may use Confidential Information for the purpose of performing their tasks and responsibilities only and are not allowed to disclose Confidential Information to anyone outside the Company without specific authorization and provided an appropriate confidentiality undertaking is in place (like a Non Disclosure Agreement). Any exchange of Confidential Information within Esperante should be limited, in a controlled and disciplined way, and on a need to know basis only.

 

 

Business Partners

  1. Responsibility for Conduct of Business Partners

22.1. Esperante expects its business partners, including licensees, customers, agents and distributors, academic groups, suppliers and services providers, to equally act in accordance with Applicable Laws in the country or countries where they conduct their business and in a socially responsible and ethical manner when providing goods or services to Esperante or commercializing any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante.

22.2. Esperante is responsible to safeguard compliance of its business partners with Applicable Laws when providing goods or services to Esperante or commercializing any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante. To the extent desirable or required (either or not by Applicable Laws), Esperante will contractually commit its business partners to comply with these Business Principles.

  1. Commitment of Business Partners

23.1. Esperante specifically requires its business partners, including licensees, customers, agents and distributors, academic groups, suppliers and services providers, where appropriate and when providing goods or services to Esperante or commercializing any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante, to abide by the following standards:

(i) to uphold the rights of workers in accordance with the laws and regulations in the country or countries where they conduct their business;

(ii) to abstain from forced labor in its broadest sense, as well as any form of slavery, human trafficking or child labor;

(iii) to comply with all environmental, health and safety laws and regulations in the country or countries where they conduct their business;

(iv) to comply with all applicable anti-bribery legislation on combating bribery of public officials in international business. In particular, business partners should not offer, promise or give any improper pecuniary or other advantage, whether directly or through intermediaries to a public official, for the benefit of that official or of a third party, for the purpose of influencing decision or actions with respect to the subject matter of any business dealings with Esperante or in the commercialization of any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante;

(v) to comply with all applicable competition and anti-trust laws and regulations that are relevant for any business dealings with Esperante or in the commercialization of any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante;

(vi) to comply with all applicable trade, economic or financial sanctions, laws, regulations, embargoes or restrictive measures imposed, enacted or enforced by the Security Council of the United Nations, the USA, the UK, the European Union or any of its member states or any other country (or any governmental institute or agency of any of the above) in which business partners are established or conduct their business;

(vii) to record and report all business dealings with and payments to or from Esperante, as well as any business dealing or payments relating to the commercialization of any products, intellectual property, know-how or technology licensed or otherwise acquired from Esperante, accurately and adequately in its books and records;

(viii) to maintain confidentiality of any confidential information of Esperante and to use such confidential information only for the purpose for which Esperante disclosed it to the business partners;

(ix) to protect personal data that business partners may process as a result of business dealings with Esperante and enable personal rights in accordance with applicable privacy laws and regulations, including, in case business partners process personal data for which Esperante is the controller, the GDPR.

 

Final Provisions

  1. Responsibility

24.1. It is the responsibility of the Board of Directors and every supervisory Employee to propagate these Code of Conduct and Business Principles and to ensure each Employee conducts business and performs its tasks and responsibilities in line with Applicable Laws and this Code of Conduct and Business Principles.

24.2. Each Employee is responsible for observing these Code of Conduct and Business Principles, including the duty to seek clarification from their supervisor when in doubt.

  1. Reporting Violations

25.1. Employees are encouraged to report any violation or suspected violation of these Code of Conduct and Business Principles to their supervisor or a senior executive of Esperante (or at Holding level, if appropriate). Esperante has a whistle blower policy in place for the reporting of any misconduct. Such report may also be made anonymously in accordance with such whistle blower policy.