The Indivumed Therapeutics Ethical Principles
Indivumed’s Mission: Through Science and Sustainability to Best Patient Care
Science is at the core of Indivumed’s efforts, and we strive for continuously pushing the boundaries of scientific cognition to discover innovations in oncological diagnosis and treatment to improve the lives of oncology patients around the world. We want to create and deliver lasting value in promoting personalized medicine and ultimately serving society, as well as maintaining the company as a trusted institution in oncology research and development.
We conduct and support cutting edge research and development to high standards of quality, ethics and integrity everywhere we operate. We follow all applicable laws and regulations, codes, relevant guidelines, and good practice standards related to safety, research quality, data protection and medical ethics as well as bioethics to generate work and results which are not only legal, but also ethically justified. We explore ways to improve access to individualized healthcare and support respective medical and scientific education and research. Insofar, we
a) strictly follow relevant informed consent procedures and protect personal data,
b) are at all times dedicated to patient safety and minimizing any risks to patients participating in any of our studies,
c) support all relevant fundamental principles like the Nuremberg Code and the Helsinki Declaration,
d) strictly follow scientifically recognized methods and approaches,
e) cooperate with most reputable partners globally,
f) share our study results, and
g) hold ourselves accountable for the quality and conduct of science carried out on our behalf by third parties.
In addition, we
a) make clear in policies, values and ongoing training that obeying the law and working ethically are basic and non-negotiable responsibilities for everyone at Indivumed and anyone who is working on our behalf,
b) document our business decisions based on well-considered rationales,
c) use control systems to identify and manage risk,
d) maintain quality management systems and standard systems to manage and control critical processes, and
e) maintain accurate books and records.
Actively Applied Integrity and Values Uphold Indivumed’s Scientific Reputation, Stakeholder Commitment and Public Trust
Indivumed runs every part of its business activities with integrity, honesty, and legitimacy. Insofar, we
a) work only with qualified third parties who are committed to ethics and integrity consistent to these Ethical Principles and the anti-bribery and anti-corruption policy set forth below,
b) ensure that personal interests and relationships do not create conflicts of interest or influence our professional judgement,
c) do not facilitate tax evasion,
d) do not allow, ask or enable others to engage in prohibited conduct on our behalf,
e) manage assets efficiently and effectively to ensure the Company gets the benefit of all its values,
f) communicate accurately, fairly and non-misleadingly in our promotional and non-promotional communications and participate in social media and other online communities responsibly,
g) respect and protect privacy and data security when collecting, storing, using and sharing personal data,
h) promote a culture of diversity, respect, inclusion and equal opportunity where success depends on personal ability and contributions to the Company, and treat others with fairness, integrity, honesty, courtesy, consideration, respect and dignity, regardless of gender, race, nationality, age, sexual orientation, or other forms of diversity, and
i) develop employee talent and support everyone in achieving their potential.
Anti-Bribery and Anti-Corruption Policy as Major Building Block of Indivumed’s Integrity Commitment
Indivumed refuses to tolerate bribery and any other form of corruption, even if we might lose business. We do not influence improperly the decisions of others, or allow ourselves to be improperly influenced, through any unjustified exchange of money, favors or anything else of value.
We, and our affiliates globally (the “Company”), are committed to complying with all laws and regulations which govern our operations in every country in which we operate. This Anti-Bribery Policy (the “Policy”) explains our individual responsibility to comply with anti-bribery and anti-corruption laws around the world and to ensure that any third parties that we engage to act on our behalf, do the same.
Since the consequences for violating anti-bribery laws can be severe for the Company and each individual concerned, and even the suggestion of corruption may damage the reputation of the Company and affect its ability to do business, the Company has a zero-tolerance attitude towards bribery. Any violation of this Policy may result in disciplinary action, up to and including dismissal in appropriate circumstances. It is therefore extremely important that any Indivumed employee familiarizes himself/herself with this Policy and strictly adheres to it.
Scope of Policy
The principles and obligations outlined in this Policy apply to all Indivumed employees globally, all members of Indivumed’s Board of Directors, and all Indivumed contractors (including agents, consultants, outsourced personnel, and other representatives). As such, each of the aforesaid persons is responsible for adhering to the Policy and safeguarding that all Company’s contractors retained understand that they are responsible for complying with this Policy when acting on behalf of Indivumed. It is the responsibility of each affiliate / local business unit to identify and strictly adhere to all any more stringent local requirements and controls, where applicable.
What is a Bribe? A bribe means (i) the offering, promising, giving, authorizing, requesting or receiving of a financial or non-financial advantage or anything of value; and/or (ii) if the purpose of the payment is to secure the improper performance of/ misuse of a person’s position.
Prohibition of Bribery
No person who is subject to this Policy shall (i) offer, provide, or authorize, a bribe or anything which may be viewed as a bribe either directly or indirectly or otherwise through any third party; or (ii) request or receive a bribe or anything which may be viewed as a bribe either directly or indirectly or otherwise through any third party, or perform their job functions improperly in anticipation, or in consequence, of a bribe.
The prohibition on accepting a bribe from, or giving a bribe to, any person applies to any person acting in the course of a business, as an employee of a business or otherwise on behalf of others in relation to their performance of their duties and to public officials. Any dealings with public officials present a particularly high risk.
Another high-risk group for contact with Indivumed employees and contractors are healthcare professionals (such as doctors, nurses, physician assistants, specialists etc.), and specifically so ones who work in a public setting such as public medical services, hospitals and other nationalized industries. Any payment to healthcare professionals may take place only if, and as far as, covered by signed cooperation agreements validly in place between Indivumed and its cooperation partners (cooperating clinics), in each such case by authorized persons(s) and in full compliance with applicable Indivumed policies and applicable law.
Otherwise, no person who is subject to this Policy shall offer, solicit or transfer any payment (including any kickback, bribe, or rebate) or any other financial or non-financial advantage or any other value (in cash or in kind), either overtly or covertly, directly or indirectly or otherwise through any third party, to any healthcare professionals in any private or public hospitals or any other medical services, whether or not related to their healthcare profession.
When in doubt, any solicited payment or transfer of any value, whether or not in connection to cooperation agreement(s), shall be reported to Legal and/or to the management without delay and it is subject to prior consultation with Legal and/or management.
Even the appearance of any improper conduct in the context of public officials would have a significant reputational impact on Indivumed’s public image, and Indivumed staff and contractors must take great care in these situations.
Under this Policy, public officials include any officer, employee or representative of the government or a fully or partially government-owned entity, and shall also extent to a legislative, administrative or judicial official, regardless of whether elected or appointed; an officer of, or individual who holds a position in, a political party; a candidate for political office; or person who otherwise exercises a public function for or on behalf of any country. This list is not exhaustive, so you should consult with your manager and/or Legal & HR partner if you have any questions or concerns.
Facilitation payments are small unofficial payments to public officials to ensure or speed up performance of routine or necessary action which is part of the public official’s usual responsibilities. These are bribes, regardless of whether they may be a part of the “way of doing business” in a particular country. As a representative of Indivumed, you must not make any facilitation payments unless you or your companions are at imminent personal physical risk if you fail to do so.
Indivumed could be held responsible for the actions of a third party (such as distributors, agents, contractors, suppliers, joint venture partners) acting on its behalf. As such, care must be taken to ensure that those third parties do not engage or attempt to engage in bribery. All Indivumed group companies shall (i) ensure that any new third parties (or third parties whose contracts are being renewed) who provide services on behalf of Indivumed contractually agree to abide by the principles set out in our Ethical Principles and this Policy, (ii) undertake sufficient due diligence in relation to any proposed acquisition or joint venture to ensure that bribery is unlikely, the results of which due diligence process shall be appropriately documented, and (iii) undertake sufficient due diligence (including checking of responses) in relation to any new third party’s background, capability and reputation to ensure that bribery is unlikely, where any of the “red flags” (see list of Red Flags further below in this Policy) are met; this shall include a search of anti-bribery and sanctions lists, checking for relationships with public officials, and appropriately documenting the results, assessments and report of the due diligence process. If the due diligence process raises any concerns, you must contact your manager and/or the Legal & HR partners immediately. For ongoing third-party relationships or those which have not previously been checked but meet the requirements above, due diligence shall be repeated on a regular basis.
Gifts and Hospitality
The act of exchanging business gifts and receiving corporate hospitality can play an appropriate role in building or maintaining business relationships. However, gifts and hospitality are problematic if
they create actual or perceived conflicts of interest, or otherwise appear to influence a business decision.
Accepting gifts, discounts, favors, or services from a current or potential customer, competitor, supplier, or service provider is prohibited if that benefit is a type or amount which has the potential to influence a person’s business decision. Functions like procurement and sales or persons with direct contact to health care personnel must take extra care. More strict requirements might apply to certain groups, and these groups might not be allowed to take or give any gifts or hospitality whatsoever under certain circumstances or policies and procedures applicable to that group. If you have any questions, please consult your manager and/or Legal & HR partner. Any gifts are only permitted if they are (i) reasonable, (ii) infrequent, (iii) in good taste, (iv) unsolicited, (v) not cash or a cash equivalent; and (vi) not given with an intent to influence a business decision.
Occasionally, for the purpose of building relationships, you may accept or offer social entertainment or hospitality, such as modest meals or event tickets. However, you must not accept or offer entertainment or hospitality unless the activity (i) permits business or educational discussions at the meal or event (a Company representative must be in attendance at the meal or event), (ii) is part of a genuine business relationship, (iii) is not intended and could not be perceived by others to improperly influence business decisions, (iv) is consistent with applicable industry practices, all applicable laws and Indivumed’s Ethical Principles and this Policy, (v) is not excessive in value or quantity, as defined by local procedural documents, and (vi) would not embarrass Indivumed, or jeopardize Indivumed’s reputation, if it was brought to public attention. Where local laws, regulations or standards apply and require more stringent processes/ controls, then such more stringent processes/ controls must be followed.
Charitable contributions may only be given to recognized non-profit charitable organizations. All such donations must be (i) transparent and properly recorded in Indivumed’s books and records, (ii) either receipted or have a letter of acknowledgement from the charity to ensure that the donations receive the proper tax treatment, and (iii) be compliant with local law, regulations and Indivumed’s Ethical Principles. Donations must not (i) be made to individuals or in hard cash, or (ii) be made at the request of a public official as an inducement to or reward for acting improperly.
Financial and non-financial records which Indivumed maintains are disclosed to shareholders, regulators and other entitled stakeholders. Accordingly, these records must be accurate and complete so that Indivumed can substantiate and justify any transactions with third parties.
All persons who are subject to this Policy must declare and record in writing all hospitality and gifts given or received, and submit expenses claims relating to hospitality, gifts or payments they made or authorizes to be made to third parties, promptly and provide justification for this expenditure. All accounts, invoices, and other records involving transactions with third parties including suppliers and customers must be prepared accurately. Under no circumstances should a person prepare an account “off- book”, particularly where this is designed to conceal an improper transaction.
There are a number of issues which should cause Indivumed to do some further investigation into whether a particular transaction or relationship may present a potential bribery risk or issue.
All persons who are subject to this Policy must remain vigilant and attempt to spot any of the scenarios listed below. If you should come across a potential issue of the kind listed below, you should (i) consider whether further investigation and due diligence of your counterparty is necessary; and/or (ii) escalate the matter to your manager and your Legal & HR partner.
Potential issues which call for further vigilance and/or investigation include:
a) The prevalence of bribery in a country that has a nexus with the particular transaction or relationship (third party is located in such country or the transaction involves such country); e.g. according to the Corruption Perception Index (CPI) as evaluated annually by Transparency International;
b) payments of unusually high fees or commissions;
c) requests for cash payments or requests for unexpected payments related to government approvals;
d) requests for payments to different companies or through different countries;
e) undefined or unreported payments to third parties made on Indivumed’s behalf;
f) payments being made which are not based on written agreements;
g) unusually close relationships with government officials;
h) a refusal to certify compliance with this Policy; or
i) payments made without reference to a PO/SoW number, where applicable.
Antitrust and fair competition policy
Unfair competition and market manipulation can significantly undermine market efficiency and fairness, as well as confidence of the customers, partners and investors in Indivumed´s business integrity.
Indivumed is committed to ensuring fair competition and to following applicable antitrust and competition laws. Therefore, all employees are required to comply with the international and national laws safeguarding fair competition. This includes in particular the provisions on unfair competition and antitrust laws.
It is strictly prohibited to engage in manipulative, illegal, anticompetitive or unethical activities, practices, or otherwise in any other conduct damaging to Indivumed´s reputation, in particular:
- Any agreements and arrangements between companies which restrict competition, such as agreements with competitors on prices, terms and conditions (for customers or suppliers), and on sharing markets, customers, or territories, restricting capacity or production, boycott of certain customers or suppliers, etc.,
- An exchange of information that could limit fair competition, including information about sensitive business information (unless previously approved or in course of due and lawful business), such as pricing and price changes etc. In principle, communication with competitors should be avoided or kept to a minimum and transparent.
- Exerting undue influence, e.g. on suppliers, imposing undue restrictions on the commercial activity of a customer without an advice from Legal Department.
- In case of dominant market position, conduct itself in order to not take unfair advantage of customers, or unfairly prevent competitors from entering, remaining or expanding in a market, e.g. providing services below costs, exclusivity arrangements (without an advice from Legal Department).
Violation of antitrust laws can result in fines, compensation claims by our customers and competitors, damage to Indivumed´s reputation and commercial relationship, as well as imprisonment, for the company, management and individuals concerned.
Any indication of anti-competitive conduct, during any contact with competitors, such as raising inappropriate topics, as exemplary described above, must be avoided, objected and reported to the Legal Department by any employee. Employees are strictly prohibited from engaging in such discussions, without first seeking advice from Legal Department.
This protects not only Indivumed but also individuals from the consequences of non-compliance. Antitrust laws in such foreign countries where we conduct business operations might have broad extraterritorial scope and application.
Employees are encouraged to contact Legal Department for any help or suspected ambiguities in applying these principles to any specific business situation, such involving the exchange of information with a competitor (e.g. before discussing joint venture R&D arrangements with competitors).
Prohibition of insider trading
Insider trading refers to the practice of a person purchasing or selling publicly-traded securities while such person is in possession of non-public material information, where such information is obtained from a breach of fiduciary duty, or has been provided under an obligation of confidentiality or due to a relationship of particular trust or confidence.
Material information refers to any information that may result in a substantial impact on the decision of an investor regarding whether or not to buy or sell the security. Non-public information refers to information that is not legally out in the public domain and that only certain people possess (e.g., based on employment or other contractual relationship). This may especially include Indivumed directors, officers, employees, consultants and agents, who are in possession of confidential information of Indivumed or Indivumed partners. The example of insider trading by the employees is a misappropriation or taking advantage of confidential information from/provided to their employer.
Insider trading undermines investor confidence in fairness and integrity of the securities markets. Indivumed is committed to comply with capital market law, including insider trading regulations.
Therefore, it is strictly prohibited to engage in insider trading activities. No person who is subject to this Policy (including Indivumed directors, officers, employees, consultants and agents) shall trade (or cause or encourage in any manner any third party to trade) in any securities of a company, while in possession of any such non-public information regarding such company, or communicate such information to any other person except under circumstances expressly permitted under applicable laws, and shall further abide by all restrictions that Indivumed may legally and reasonably impose, until the relevant information has been made public or no longer constitutes material non-public information.
Fair treatment values
Indivumed is committed to valuing respect and dignity of the employees.
Indivumed shall not tolerate any disrespectful behavior, verbal or physical sexual or any other harassment, intimidation, coercion, hostility or mental or physical abuse of any kind.
Indivumed shall not deploy child or trafficked labor or any other kind of involuntary labor and strictly abide by applicable labor law with regard to any employment requirements, especially concerning minimum working age and work conditions. Indivumed shall ensure that the employment is conducted on the basis of freely agreed, understood and documented terms, which had been made available to the respective employees. Indivumed`s remuneration system, including wages, (overtime) working hours and benefits, shall abide by applicable labor law and local regulation.
Indivumed shall not tolerate discrimination based upon an individual’s race, color, sex, national origin, ethnicity, age, religion, disability, marital status, pregnancy, sexual orientation, gender identity and expression, citizenship, political affiliation, union membership or any other characteristic protected by law.
Indivumed values diversity amongst employees and provides equal opportunity and advancement opportunities for all individuals, according to applicable law.
Indivumed shall strive to resolve any employment-related matters respectfully and as quickly and as confidentially as possible.
Indivumed encourages employees to report any (suspected) breach of these principles and does not tolerate retaliation against anyone for making an employment-related complaint or cooperating with an investigation concerning discrimination or harassment.
Indivumed encourages employees to open communication with management regarding any workplace issues to seek representation and to free choice of participation in accordance with national law in labor unions or workers’ councils, without threat of reprisal or intimidation.
The Ethical Principles: A Constant Commitment for Everyone at Indivumed
All of us at Indivumed are accountable for upholding the Ethical Principles including to the Policy. Managers are also responsible for helping their teams to understand and apply them. In addition, Indivumed will only work with third parties who share the core values of our Ethical Principles including the Policy.
These Ethical Principles set forth Indivumed’s minimum compliance standards with respect to internal organization and procedures, and our interaction with third parties. Yet, the Ethical Principles cannot cover every situation, and hence cannot per se replace good judgement, and where local laws or regulations require more stringent controls, then such more stringent controls must be followed.
Whenever anyone subject to these Ethical Principles is in doubt of whether or not an intended decision conforms to the Ethical Principles and its guiding principles, or has any question whatsoever related to it, all managers and the Legal & HR partners are always here to help.
Should anyone subject to these Ethical Principles notice or suspect anything goes wrong, he/she should please not hesitate to report any concerns to the respective superior in the first place, any person of the management, or the Legal & HR partners.