Code of ethics

This document, known as the “Code”, adopted by the general management of the ExCEEd Orphan s.r.o., company with its registered office U Habrovky 247/11, Krč, 140 00 Praha, business ID: 07407696, registered in the Commercial register by the Municipal Court in Prague, file no. C 300530 (hereinafter referred to as the “ExCEEd Orphan”) sets forth the rights, duties and responsibilities which ExCEEd Orphan and its employees expressly utilize in their dealings with interested parties with whom they come into contact whilst performing their everyday activities.

This Code lays down a series of ethical principles and values on which the activities of everyone working at ExCEEd Orphan must be based, bearing in mind the importance of their roles, the complexity of their functions and the responsibilities entrusted to them for the purpose of achieving ExCEEd Orphan’s objectives and goals.

OUR FOCUS – Rare diseases and orphan drugs market and business development in Central & Eastern Europe.

OUR MISSION – To serve each and every patient with rare disease by deploying our knowledge, experience and passion in enabling access to orphan drugs in Central & Eastern Europe.

OUR COMMITMENT – To deliver your unique medicine to each and every patient with rare disease by providing integral business solutions, fully in line with your internal processes and local legal and regulatory requirements.

2. RECIPIENTS

An ethical focus is vital for the reliability of ExCEEd Orphan’s behavior towards the customers, patients, health care professionals (hereinafter referred to as the “HCP”), governmental officials and the society in general. Therefore, the provisions of this Code apply to everyone, with no exceptions, working at or for ExCEEd Orphan, especially its employees, managers, executives and directors, collaborators, suppliers and any other person regardless of whether it is a legal entity or a natural person who, directly or indirectly work for the company (hereinafter referred to as the “Employees”).

3. BASIC ETHICAL PRINCIPLES

3.1. Compliance with the Law

A fundamental principle for ExCEEd Orphan is compliance with the current laws and regulations and ExCEEd Orphan’s Employees must strive to observe such principle. This commitment must also apply to all suppliers, customers and anyone who has contractual relationships with ExCEEd Orphan. ExCEEd Orphan will not start or continue any relations with anyone who does not intend to commit to the principle of rigorous respect for the law.

ExCEEd Orphan also act in the full extent of the ethical codes of the European Associations of Pharmaceutical Industry (EFPIA, AIPM, etc.) regarding to the interactions and cooperation with HCPs.

3.2. Anti-corruption / anti-bribery

Consistent with its values, ExCEEd Orphan strives to implement all the measures required to prevent and avoid phenomena of corruption. ExCEEd Orphan complies with all applicable laws and regulations prohibiting bribery of government officials or private sector employees including US FCPA. ExCEEd Orphan will not under any circumstances provide, offer or promise any bribe (including money, goods, hospitality, gifts or any other item of value), benefit or advantage, directly or indirectly, to government officials or foreign government officials or private sector employees. In addition, ExCEEd Orphan will not provide any payment or benefits to private sector employees to influence them to obtain or retain a business advantage.

ExCEEd Orphan Employees will never act in such a way that their conduct can raise suspicions of corruption conduct in the relevant authorities.

ExCEEd Orphan will also ensure that those who act on behalf of ExCEEd Orphan, such as agents or proxies will not engage in any corrupt practice.

3.3. Interactions with HCPs

Consistent with ExCEEd Orphan’s strives to implement all the measures required to prevent and avoid phenomena of corruption (see Sec. 3.2 of this Code), the following basic rules of interactions with HCPs shall be binding for any Employees during the performance of any business activities related to ExCEEd Orphan.

The hiring of the HCP as advisor or consultant shall not be performed in ways it could be considered as an inducement to recommend, prescribe, purchase, supply, sell or administer a particular medicinal product.

Any compensation for the services provided to the HCP has to be reasonable and reflects the fair market value of the services provided.

No gifts, benefits or advantages towards the HCPs are permitted in the relations of the business activities of ExCEEd Orphan. Only exemption are gifts of minor value related to the HCP activity.

Any hospitality provided to the HCPs related to the services which the HCP provides to ExCEEd Orphan has to be moderate and proportionate to avoid the doubt of undue influence of the HCP.

3.4. Principles of conduct in institutional relations

It is not prohibited to enter into contact with the governmental official, public officers or subjects performing public services, but it is prohibited to act in any way which could be considered as undue influence or even corruption.

Gift-giving may be a customary practice in some cases. However, gifts can create the appearance of improper influence. The basic policy of ExCEEd Orphan is to avoid any provision of gifts or benefits to the governmental officials, public officers or subjects performing public services by the Employees.

ExCEEd Orphan’s relationships with local, national or international institutions are based on maximum transparency and correctness. Relations with representatives of public institutions are exclusively carried out by regularly authorized company functions, in full observance of the law and regulations and may in no way compromise the integrity and reputation of ExCEEd Orphan.

For this purpose, ExCEEd Orphan will not directly or indirectly offer sums of money or other means of payment or other benefits to public officers or subjects performing public services for the purpose of influencing the way they perform their duties.

These requirements cannot be eluded by using different forms of contributions, disguised as sponsorships, appointments, consultancies, advertising, etc., incorporating the above forbidden aims.

3.5. Accounting transparency / Money-laundering

ExCEEd Orphan is committed to keep all the accounting books and tax records in order and in line with the requirements of the respective legislation and guidelines of the relevant state authorities.

All transactions and financial operations must be adequately recorded, and it must be possible to verify the relative decision-making, authorization and performance processes. Each operation must be adequately documented in order to allow the characteristics and reasons for the operation to be checked at any time and to identify the persons who authorized, performed, recorded and verified the operation in question.

Accounting records must be accurately, completely and promptly kept in respect of company accounting procedures, in order to give a true representation of corporate assets/finances and of management activities. Accounting entries comprise all the documents which numerically represent management events, including internal expense reimbursement reports. All accounting information, both general ledger and management, must comply with the principles of clarity, transparency, correctness, completeness and accuracy.

ExCEEd Orphan is committed to observing all national and international regulations and provisions concerning money-laundering. ExCEEd Orphan’s Employees must not establish relationships or stipulate any agreement with business partners if they are aware that their interlocutors are involved in laundering money deriving from illegal or criminal activities.

3.6. Confidentiality and Personal data

ExCEEd Orphan considers the personal data it processes as strictly confidential. Processing of the personal data is governed by the internal guideline. Any processing of personal data shall be carried out in accordance to the Regulation (EU) 2016/679 of the European parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) and any applicable local legislation. Although the legislation may vary from country to country, at a minimum, however, ExCEEd Orphan will always adhere to the following:

ExCEEd Orphan will collect personal data only for legitimate business purposes and by lawful means and will not disclose or use personal data for purposes other than a legitimate business purpose or as required by law.

ExCEEd Orphan will protect personal data by reasonable security safeguards against accidental loss or destruction or unauthorized access, use, modification or disclosure.

ExCEEd Orphan protects all the information acquired in the course of its business activities as trade secret as stipulated in the applicable local legislation (for the territory of the Czech Republic as stipulated in Sec. 504 of the Act. No. 89/2012 Coll., Civil Code, as amended). It will not use this information in its own interest for the purpose of making an unfair profit or according to methods that are illegal or harmful to its objectives.

ExCEEd Orphan never provide, publish or make available in any way any information considered as confidential without the prior written consent of the person who provide it with such information.

Each collaborator, associate or any other external subject who came into contact with the confidential information or personal data are required not to use such information or data for purposes other than the performing of their professional activities for which they were approached by the ExCEEd Orphan. ExCEEd Orphan will provide such person with the respective confidentiality agreement to assure fulfillment of this obligation.

3.7. Responsibility towards the society

ExCEEd Orphan is aware of the effects of its activity on the reference context, on social-economic development and on general public well-being. For this reason, it intends to consistently make its investments in respect of the environment and the requirements of the local and national communities, whilst promoting initiatives of scientific, cultural and social value in order to constantly improve its reputation and social standing.

3.8. Impartiality

ExCEEd Orphan abstains from all forms of discrimination, including age, gender, sexuality, health, marital status, race, political opinion and religious beliefs.

3.9. Conflict of interest

ExCEEd Orphan Employees must avoid situations in which conflicts of interest may arise and must not perform activities that may potentially conflict with the interests of ExCEEd Orphan.

For example, conflicts of interest can include:

a business interest – evident or concealed – of an employee or a member of his/her family with a supplier, customer or competitor;
exploitation of his/her position in order to promote interests contrasting with those of ExCEEd Orphan;
the use of information acquired during business activities to his/her advantage or that of third parties contrasting with the interests of ExCEEd Orphan;
working activities of any kind (labor or intellectual) for customers, suppliers, competitors and/or third parties contrasting with the interests of ExCEEd Orphan;
the conclusion, stipulation or start of negotiations and/or contracts – for and on behalf of ExCEEd Orphan – with an employee s family members or partners, or legal persons of which he is the owner or in which he/she has an interest;
acceptance of money or other benefits in favor of persons or companies which enjoy or intend to enjoy business relations with ExCEEd Orphan.

It is forbidden for Employees to take personal advantage of business opportunities that came to his/her knowledge whilst performing his/her activities at ExCEEd Orphan.

3.10. Intellectual property rights

All intellectual property owned, developed or obtained by ExCEEd Orphan through research, development, or other activities (including patents, designs, copyrights, trademarks, know-how, data and technical knowledge) are vital assets of ExCEEd Orphan. Therefore, each Employee is obliged to carefully safeguard ExCEEd Orphan’s intellectual property and fully cooperate in the establishment, protection, maintenance and defense of intellectual property rights.

The unauthorized use of the intellectual property rights of other parties may expose ExCEEd Orphan to civil lawsuits and claims for compensation; the theft and misappropriation of intellectual property may lead to elevated fines and penal consequences for ExCEEd Orphan and individuals. Therefore, ExCEEd Orphan respects intellectual property rights of third parties (e.g. customers, partners). Therefore, it will not misappropriate or infringe upon intellectual property rights of third parties in any way. In case the intellectual property of third party has to be used by ExCEEd Orphan to achieve the agreed outcome, the respective contract (license) has to be concluded between the ExCEEd Orphan and the third party.

3.11. Health, safety and the environment

ExCEEd Orphan is committed to promoting, spreading and consolidating the culture of safety, developing all its Employees awareness of risks and attitude towards responsible behavior. ExCEEd Orphan therefore protects the environment and pays particular attention to the creation and management of suitable working areas and environments regarding occupational health and safety, in compliance with national directives.

The environment is a primary asset that must be protected; consistent with this principle, ExCEEd Orphan plans its activities by striking the best possible balance between economic initiatives and environmental needs, considering the rights of present and future generations.

ExCEEd Orphan’s environmental policy is based on the conviction that, as well as being a public asset to safeguard, the environment can be a competitive advantage in a market that is becoming more and more global and attentive to the quality of life and corporate behavior.

ExCEEd Orphan therefore strives to prevent risks to the public and the environment, in accordance with current regulations.

4.IMPLEMENTATION OF THE CODE

The executive of ExCEEd Orphan Jiri Hermanek designated as a Compliance Manager is authorized to verify the application and implementation of the Code. The Compliance Manager has the following tasks:

periodically audit the application and observance of the Code;
propose modifications and additions to the Code;
receive reports of breaches of the Code and investigate accordingly in cooperation with independent external legal advisors (KMVS);

All ExCEEd Orphan Employees are required to co-operate with the Compliance Manager, providing any company documentation required to allow it to carry out his duties. In case of doubt as to the legality of a certain action, its ethical value or its consistency with the Code, the person involved may contact the Compliance Manager.

Reports of any illegal actions must be made in writing and may be sent to Compliance Manager. All reports received will remain strictly confidential.

5. EFFECTIVENESS OF THE CODE AND AMENDMENTS

This Code is effective from March 1,2020 and it is published on the ExCEEd Orphan’s official web site www.exceedorphan.com.

I case of any change or amendment of the Code, the amended version will be published the same way as the Code. All previous versions of the Code shall be archived by the Compliance Manager.

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