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Business ethics

Policy on anti-corruption, gifts and hospitality

1. Introduction and scope

XVIVO Perfusion AB and all its subsidiaries and affiliates (“XVIVO”) shall observe high standards of ethical and business conduct in their operations and are committed to combatting all forms of corruption. XVIVO shall conduct its activities in compliance with the from time-to-time applicable anti-corruption laws in the markets in which XVIVO conducts business, such as the Swedish Penal Code and the U.S. Foreign Corrupt Practices Act (“FCPA”). For U.S. cooperations and U.S. citizens, residents, or any other person to whom the FCPA is applicable, please see Appendix 1 which, inter alia, contains an overview of the FCPA. XVIVO shall also conduct its activities in compliance with the Physician Payments Sunshine Act as well as relevant legislation from the European Union and the United States.

The purpose of this Policy on Anti-Corruption, Gifts and Hospitality (the “Policy”) is to articulate XVIVO’s zero tolerance to corruption and to provide guidance on XVIVO’s standards of conduct regarding bribery, gifts and hospitality.

The Policy applies to XVIVO, its employees, directors, officers, agents and board members (collectively referred to as “Employees”). It also applies to XVIVO’s business partners acting on behalf of XVIVO with or through an agent, consultant, joint venture or other business partner (“Business Partners”). As an Employee or Business Partner you are responsible for reading, understanding and complying with the Policy. As a manager you are also responsible for ensuring compliance with, and the understanding of, the Policy within your respective parts of the organisation.

Any Employee or Business Partner who violates applicable laws and/or the Policy may be subject to legal and/or disciplinary actions, including dismissal and termination of contract. Violations of applicable anti-bribery laws could result in criminal and/or civil liability.

2. What is an undue benefit?

Not all benefits[1] are prohibited since the exchange of gifts and hospitality[2] can create goodwill and establish trust in business relationships. A benefit that is undue is however prohibited. This is because an Employee or a Business Partner who gives, promises or offers an undue benefit for the performance of the recipient’s duties may commit a bribery offence. The same applies if the Employee or Business Partner receives, accepts a promise of or requests an undue benefit for the performance of his/her duties. A benefit can be undue even if the benefit does not have an actual impact on the recipient’s performance of their duties; it is enough that the benefit objectively may create a risk for such an impact. You should also be aware that a request for, or an offer of, an undue benefit is enough for criminal responsibility; the actual transaction does not have to be concluded.

Make sure to always consult the Checklist in Appendix 2 prior to offering or accepting a benefit. In this regard, particularly note that some benefits require prior written approval.

2.1 How do you assess if a benefit is undue?

An assessment of whether a benefit is undue, and thereby prohibited, is generally based on the criteria below:

Openness – A benefit that is directed at a particular person is more likely to be deemed undue, than a benefit directed at the recipient’s principal organisation. Any benefits, such as invitations, should therefore generally be directed to the organisation.
The recipient’s position – In general, any benefits to Public Officials[3], including health care professionals (“HCP”)[4], should be dealt with in a very restrictive manner. Any provision of benefits to individuals in a position to influence public power or public procurement is not allowed. Within the private sector, lawyers, auditors and controllers hold particularly sensitive positions in terms of integrity.
The value and nature of the benefit – There is no fix amount defining an undue benefit. Benefits of a higher financial value however carry a higher risk of impacting the actions of the recipient. Benefits of insignificant financial value, such as smaller marketing items, rarely carry such a risk. The provision of cash payments, gift vouchers and other items similar to cash payments, are usually considered undue.
Consent – For recipients in the private sector, the consent of the recipient’s principal organisation often authorises the benefit. For public officials, the principal organisation cannot legally allow the receipt of a benefit.
Quid Pro Quo arrangements – Benefits that are provided on a quid pro quo basis are in principle always deemed as improper. This includes benefits provided as gratitude for previous action(s).
Timing – If the benefit is offered at the time, or in close proximity, of decision-making relevant to XVIVO, for example a procurement exercise, any provision of a benefit would often be deemed as undue.
Personal relationships – It happens that personal relations are used as an explanation for benefits being provided and received. If the relations are mainly built on professional connections between the parties, the benefit may still be considered as undue.

Considering the criteria above, it is important that all benefits always meet the following requirements (noting that the below is not an exhaustive list):

  • Must be modest, reasonable and infrequent so far as any individual recipient is concerned.
  • Must not be given or received with the intent or prospect of influencing the recipient´s decision-making or other conduct.
  • Must constitute normal business courtesy.
  • Grants, donations and sponsorships must only be given if XVIVO does not receive, and is not perceived to receive, any consideration in return and shall always receive prior written approval from XVIVO’s CCO or Global R&D Director.
  • Must comply with any applicable laws, including those which may apply to relevant public officials (see further section 4. below)

The following benefits are always prohibited:

  • Cash or cash equivalents, such as gift vouchers.
  • Benefits to public officials, including HCPs, in a position to influence procurement, purchasing, issuance of permits or other similar exercise of public power.
  • Facilitation payments[5].
  • Benefits used to contribute, directly or indirectly, to any political party, political candidate or political campaign.

It is important to recognise that anti-bribery legislation is more stringently applied in relation to the public sector and it is therefore important that you carefully read section 4. below.

We remind you that you shall always consult the Checklist in Appendix 2 prior to offering or accepting a benefit. In this regard, particularly note that some benefits require prior written approval. In case of uncertainties, always consult your closest manager.

3. Business Partners

XVIVO requires our Business Partners to abide by ethical standards in line with those of XVIVO and to comply with all applicable laws. Appropriate due diligence must be undertaken before any engagement with Business Partners. This is important since XVIVO could be held legally responsible for criminal acts conducted by our Business Partners. XVIVO may also conduct due diligence of already existing Business Partners. The level of due diligence is risk-based and will vary depending on the circumstances. Any risks identified by XVIVO when conducting the due diligence shall be evaluated. Personnel working with agents and other third parties should pay particular attention to unusual or suspicious circumstances that may indicate possible legal or ethics concerns, commonly referred to as “red flags” such as:

  • Transactions involving a country or sector known for corrupt payments;
  • Background checks that raise questions about a third party’s reputation, qualifications or trustworthiness;
  • A third party suggested or recommended by a Government Official;
  • Family or other relationships that could improperly influence the decision of a customer or Government Official;
  • Compensation arrangements that are disproportionate, non-transparent or otherwise unusual; and
  • A third party who objects to FCPA representations and warranties or other elements of this Policy.

The presence of red flags in a relationship or transaction requires greater scrutiny and implementation of safeguards to prevent and detect improper conduct.

Business Partners must be engaged through a fair and formal process and only when there is a legitimate need for the services provided by the Business Partner. The engagement shall be documented in a written contract that, where appropriate, includes anti-corruption requirements. Employees who manage, supervise and/or oversee the activities of third parties working with XVIVO are responsible for ensuring that such persons or entities understand and fully comply with this Policy, through appropriate measures. Business Partners may be required to complete Appendix 3 attached hereto prior to engaging in any activities with or on behalf of XVIVO.

4. Interaction with public officials and health care professionals

It is important that you recognize that Public Officials, including HCPs, are often subject to stricter rules and restrictions that do not apply to persons who operate in the private sector. Therefore, any interaction with Public Officials and HCPs – and particularly in relation to procurement, purchasing, permits and similar exercise of public power – requires particular attention by XVIVO, as well as you as an Employee or a Business Partner.

It is strictly prohibited to offer any form of benefit, either directly or indirectly, to any Public Official in the following situations:

a) In the context of an ongoing or imminent public procurement procedure;

b) In order to unduly influence the exercise of public authority, e.g., in connection with inspections, investigations and similar performed by authorities or public agencies.

Furthermore, it is strictly prohibited to offer, directly or indirectly through a third party, facilitation payments, irrespective of whether facilitation payments are legal in the country in question. An example of a facilitation payment is when a benefit is given to a Public Official in order to influence him/her to perform his/her professional duties in a certain way, e.g., to expedite the processing of a permit or licence application.

Benefits directed at public officials and HCPs shall always be dealt with in a very restrictive manner and require prior written approval from XVIVO’s CFO.

4.1 Health Care Professionals

Most countries have laws and regulations specific to the healthcare sector that prohibit using something of value that could influence referrals, recommendations or the purchase or order of a product or service. In addition, many countries have adopted industry codes that address different types of interactions with HCPs.

Entertainment and hospitality may be forbidden under the healthcare laws and local industry codes of some countries. It is important that you know and adhere to the rules and restrictions of applicable local laws, as well as this Policy, when interacting with HCPs. When entertainment and hospitality is permitted, it must always be subordinate in both time and focus to the purpose of the meeting.

All speaking engagements, consulting arrangements, appointments to advisory board, or other similar opportunity offered to a HCP must always be based on a legitimate business need, compensated in accordance with fair market value, permitted by the HCP’s own company policies and documented in a written contract reviewed by CCO. Contracts entered into with HCPs should, where appropriate, also include written anti-corruption requirements.

4.1.1 Cases

Q: We have invited an HCP to attend a training session at an approved XVIVO training site. The HCP is asking to stay at a luxury hotel. How should you respond to their request?

à Paying for accommodation in connection with a training session could be an acceptable practice depending on the circumstances, but monetary values must be consistent with industry standards. A luxury hotel most certainly is out of bounds and could be seen as an attempt to unduly influence the HCP. You should politely explain to the HCP that XVIVO has guidelines in place for the protection of both XVIVO and its business partners, and that such guidelines do not permit hotel accommodations of this type.

Q: A HCP working for one of XVIVO’s customers offers to volunteer as a speaker to talk about his experiences with XVIVO’s products at a few industry events. He is asking for a consultancy fee that is higher than standard but suggests that this engagement could help XVIVO gain a new order from his hospital. Can you proceed with the engagement?

–> Engaging a HCP for a service must never be, and must never be perceived to be, connected to the purchase of XVIVO’s products or services. Engaging the HCP under these circumstances is prohibited.

5. Procurement

Procurement and contracting decisions must always be based on the best value expected, considering XVIVO’s business requirements and interests, taking into account the merits of price, quality, performance, competence, and suitability. No Employee or Business Partner acting on XVIVO’s behalf may solicit or accept any financial or other advantage as an inducement or reward for any improper performance of duties related to procurement or contracting decisions.

6. Accurate Records

It is XVIVO’s policy to keep books and records that accurately and fairly reflect XVIVO’s transactions in reasonable detail. No false and inaccurate entries may be made in the books and records for any reason, and all payments and transactions, regardless of value, must be recorded accurately.

Any records provided by business partners, including HCPs, to XVIVO must be accurate and include reasonable details to exclude that any part of the invoiced amount finances potential undue benefits to any third party. XVIVO’s business partners shall retain, for a minimum period of five years, complete and accurate records of all costs incurred for their work performed on behalf of XVIVO.

7. Training

Training concerning this Policy is part of the introduction program for all new employees. In addition, XVIVO’s employees, members of the board, the management of XVIVO and Business Partners acting on behalf of XVIVO (such as, e.g., certain agents, distributors and retailers) are obliged to participate in, and pass, the regular anti-corruption training sessions offered by XVIVO.

8. Guidance and the reporting of violations

If you have any questions, you are encouraged to seek guidance from XVIVO’s CFO in relation to the content and/or interpretation of the Policy. If you as an Employee or Business Partner knows of any actual or potential violations of applicable laws or the Policy, you shall immediately report this either to XVIVO’s CFO or by using XVIVO’s whistleblowing channel, through which misconducts can be reported anonymously. XVIVO will protect anyone who report such violations in good faith. Retaliation in any form against an Employee or Business Partner who has, in good faith, reported a violation or possible violation of this Policy is strictly prohibited.

9. Implementation and maintenance

The board of directors of XVIVO is ultimately responsible for the implementation, compliance with and review of this Policy. The board of directors may designate any officer or other executive from time to time to assist with implementation of this Policy. The CFO is responsible for taking all measures necessary for an effective implementation of this Policy and for regular evaluations of its effectiveness as well as for submitting proposals to the board of directors of XVIVO to adopt improvements when deemed appropriate to ensure effectiveness.

Appendix 1
Appendix 2
Appendix 3

XVIVO Code of Conduct approved by the Board of Directors on October 19, 2023

[1] A benefit includes gifts and hospitality activities, such as dinners and events, as well as loans, favours etc.
[2] Hospitality includes e.g. travel, accommodation, meals and pleasure, such as sports and entertainment.
[3] A Public Official is any employee or representative of a public organisation, such as a government, municipality or international organisation. Employees or representatives of publicly owned companies are also to be considered as public officials.
[4] Health care professionals include members of the health care profession and any other person who, in the course of their professional activities, make decisions on behalf of health care facilities or who may recommend the purchase of, supply or administer a medical product. Health care professionals, employed by government or public organizations, should for the purpose of this Policy be considered Public Officials.
[5] Facilitation payments are unofficial payments to a public official for the purpose of enabling or speeding up a process that is their duty to perform, such as issuing permits, licenses or other official documents and processing governmental papers.

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