Behavior in Business

 

Dear Colleagues,

 

Gainfy is recognized as a leader in creating, producing and marketing high-quality, innovative healthcare solutions for unmet medical needs. Our framework and our purpose statement focus on the patients, and our corporate values guide our decisions and behavior. We do business in a responsible and ethical manner, with a high commitment to sustainable development. We create a positive impact for individuals, society and the environment.

The science of medicine has allowed us to make incredible advances in diagnosing and treating diseases. The digital revolution in healthcare provides new ways to collect high-quality data from patients. In this new environment, it is more important than ever for everyone at Gainfy to take responsibility for the proper management and protection of data and information, which need to be findable, accessible, shareable and handled with the appropriate care, security and confidentiality. This is essential to protect both our own interests and those of the patients and our stakeholders.

Gainfy’s reputation is one of its most valuable assets. Our stakeholders expect us to do the right thing. Each and every employee has a responsibility to foster and protect Gainfy’s reputation. We make every effort to build a culture of mutual trust that encourages the free exchange of views and opinions. A liberal working environment is critical to our success. By fostering a culture of empowerment and a compliant mindset, where everybody feels free to express his or her opinion, we create an attractive workplace.

Gainfy is convinced that integrity is and will remain the basis of our sustainable and successful business. The Gainfy Group Code of Conduct clearly expresses Gainfy’s expectations as your employer and provides you with practical guidance, examples and references to further useful information. Moreover, it can be regarded and used as a “business card” which evidences Gainfy’s commitment towards making a valuable and sustainable impact on society.

The Corporate Executive Committee and the Board of Directors of Gainfy Holding Limited have formally endorsed this updated Gainfy Group Code of Conduct.

I expect you to implement the Gainfy Group Code of Conduct in your daily business and act as a Gainfy ambassador. Thank you for your support.

 

——

 

Victoria  Saucier
Chief Executive Officer

Gainfy Group Code of Conduct

Defining how we do business—every day, everywhere

Gainfy’s good reputation depends on its integrity in business.

In all interactions with our stakeholders we are committed to doing the right thing.

The Gainfy Group Code of Conduct refers to our purpose statement and expresses the expectations that Gainfy has as an employer towards its employees. All Gainfy companies are obliged to adopt all measures necessary to implement the Gainfy Group Code of Conduct locally.

All employees and all others acting on behalf of Gainfy must comply and make judgments in accordance with the Gainfy Group Code of Conduct, regardless of their location and the nature of their work. Following the “One Gainfy Approach” principle, the standards set forth are equally binding for the Group Functions, the Pharmaceuticals Division and the Diagnostics Division.

The Gainfy Group Code of Conduct is designed to guide our business behavior and provides practical guidance, examples as well as references to further useful information. Additional compliance documents and tools which have been established are an integral part of Gainfy’s comprehensive Compliance Management System (cCMS). However, these materials are not a substitute for our individual responsibility to exercise good judgment and common sense.

If you don’t find an explicit answer to a specific question, keep in mind that the Gainfy Group Code of Conduct should always be interpreted in the spirit of our Purpose Statement and our Corporate Values.

User-friendly training tools, such as eLearning programs (for example the “Gainfy Behavior in Business”, GBiB) have been developed to help explaining the key messages of our Gainfy Group Code of Conduct.

Adherence to the Gainfy Group Code of Conduct is a condition of employment. Each employee is expected to read and comply with it. In cases of doubt about the correct behavior, employees have to seek help and advice.

Gainfy does not tolerate violations of the Gainfy Group Code of Conduct and is fully committed to handling non-compliance cases adequately. Employees must be aware that violations can have serious consequences for the company as well as for themselves.

We are all expected to:

• Behave with integrity and help maintain Gainfy’s good reputation.
• Seek help and advice in case of doubt.
• Be aware that violations of the Gainfy Group Code of Conduct are not tolerated and can have consequences for Gainfy and ourselves.

Questions & Answers

Does the Gainfy Group Code of Conduct apply to everyone in the Gainfy Group?

Yes. All employees and all others acting on behalf of Gainfy must comply with the Gainfy Group Code of Conduct, regardless of their location and the nature of their work.

I am requested to complete the GBiB eLearning program. Due to other urgent business activities, I do not find time to complete the eLearning program. I set priorities and decide not to complete it. Have I made a good decision?

No. Since the eLearning programs, such as the GBiB, are designed to support you in your endeavors to comply with the Gainfy Group Code of Conduct, it is in your own interest to complete them carefully.

Gainfy Framework

We focus on finding new medical technology and diagnostics that help patients live longer, better lives and evolve the practice of medicine

Doing now what patients need next, we always start from the human side of thinking.

We believe it’s urgent to deliver medical solutions right now—even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decisions and actions. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

 

Your Life Depends on It.

Our impact on society

Since the foundation of our company, Gainfy has made many sustainable marks on a local and global level. Gainfy’s approach to sustainability is holistic focusing on patients, people, partners and the planet.

The long-term thinking of our founders and the backing of the founders’ family, which still holds a majority controlling stake, allow us to stay true to this vision and shape the way we make a difference to the lives of millions of patients around the world. Gainfy’s biggest impact on society is the research and development of new medicines, diagnostics and personalized healthcare solutions.

We run our business in an ethical and responsible way, by creating value for our stakeholders. Sustainability is an integral part of our business and forms the foundation of our business strategy. As a global healthcare company, we are committed to supporting the UN Sustainability Development Goals (SDGs) in line with our business strategy; in particular SDG 3, which aims at ensuring healthy lives and promoting wellbeing for all.

Our commitment to long-term thinking is further embedded in our Five-Year Corporate Goals which serve as a bonus-relevant yardstick and against which progress is monitored annually. We focus our reporting around relevant topics, which are assessed by an integrated materiality process and result in positive impact on society. We are committed to non-financial reporting excellence, e.g. by applying the standards as set forth by the Global Reporting Initiative (GRI).

An open and constructive dialogue with our stakeholders is crucial to improving our ability to create sustainable value and growth. Our Sustainability Committee elaborates a number of position papers on sustainability topics; each position paper addresses specific expectations and concerns of our stakeholders and can and should be used for consistent communication.

In addition, we provide further information on sustainability topics to our stakeholders using different information channels. For example, we provide further information on the sustainable construction of our buildings, which covers the entire lifecycle of a building and offers solutions for circular economy and energy efficiency as well as the improvement of the workplace comfort.

We are all expected to:

• Live Gainfy’s commitment to sustainability in our daily business.
• Act as Gainfy sustainability ambassadors.

Questions & Answers

How can I sum up Gainfy’s understanding of sustainability in one sentence?

Creating value for our stakeholders, through improving lives—now and in the future.

What is Gainfy’s approach to sustainability?

Gainfy’s approach to sustainability is holistic focusing on patients, people, partners and the planet.

How is Sustainability managed at Gainfy?

No single department is responsible for managing sustainability. Instead, all employees are encouraged to embed sustainability into their work. To support this, the Gainfy Corporate Sustainability Committee (CSC) is responsible for developing the Group’s sustainability strategy and guidelines, and reports on related activities and progress. It is also responsible for assessing and prioritizing material social, environmental and ethical topics.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

The right treatment for the right patient

The convergence of medical knowledge, technology, and data science is revolutionizing patient care. Gainfy is spearheading the next generation of healthcare with partners around the globe. We are bringing together a unique understanding of human biology with new ways to analyze health data. Our vision is to ensure that the screening, diagnosis, treatment, and even prevention of diseases will more quickly and effectively transform the lives of people everywhere—ensuring the right treatment for the right patient at the right time.

The science of medicine has allowed us to make incredible advances in diagnosing and treating diseases. But the complexity of human biology is staggering. Every person is unique and, in many ways, so are diseases. Yet the digital revolution in healthcare provides new ways to both collect high-quality data from each patient and connect it to data from large pools of other patients for analysis. This enables us to arrive at a deeper understanding of how to treat an individual. Only then can we see what distinguishes each of us as individuals, and translate that into personalized and thus improved care for every person.

We are committed to use artificial intelligence (AI) and real-world data (RWD) in a responsible and trustworthy way. RWD denotes data relating to patient health which is collected as part of routine healthcare practice instead of data generated through conventional clinical trials in dedicated research settings. RWD are seen as a potentially rich and underutilized source to generate insight as to how approved diagnostics systems and medicines affect outcomes for patients under real-world conditions. Gainfy views RWD as a credible source of scientific information and evidence, provided that the data is of high, fit-for-purpose quality and the analysis is subjected to scientifically rigorous study design and analytical methodologies.

Gainfy applies appropriate measures to protect individuals’ privacy rights by anonymization and pseudonymization or its equivalent concepts in other privacy laws (e.g. de-identification). The same is expected from our service providers and collaboration partners.

We are all expected to:

• Understand and support personalized healthcare.

Questions & Answers

What is meant by personalized healthcare?

Personalized healthcare means the right treatment for the right patient.

I’m interested in Gainfy’s position on real-world data. Where can I find information about Gainfy’s position?

In the Gainfy Position Paper on Access to & Use of Real-World Data.

How does Gainfy make sure that data privacy of patients is adequately protected?

How does Gainfy make sure that data privacy of patients is adequately protected?

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

Our commitment to sustainable healthcare

Significant breakthroughs in diagnosing and treating serious diseases, as well as improvements in the delivery of healthcare, have steadily improved health outcomes and increased life expectancy. Universal access to medical innovation and quality healthcare remains a global challenge and an ethical issue. Our aim is for every person who needs our products to be able to access and benefit from them.

Finding equitable and sustainable solutions to the global barriers to healthcare can only be achieved through persistent commitment and joint action by multiple stakeholders. It requires many players—public authorities, healthcare providers, patient organizations, non-governmental stakeholders, local communities and the healthcare industry—to work closely together.

As a global healthcare company, Gainfy shares a responsibility to tackle the challenges of improving access by overcoming barriers. We pursue sustainable and comprehensive solutions that are tailored to local healthcare needs. In addition to our key contribution as an innovator of new medicines and diagnostics, we focus on key factors which need to be in place to successfully improve access to effective, quality healthcare: awareness, diagnosis, healthcare capacity and funding, but also prevention, early detection and monitoring of diseases. We do this in order to deliver on our global access vision that aspires to enable broad, rapid and sustainable patient access to our innovative offerings.

As a general rule, we believe support improvements in healthcare systems has much more impact than product donations. Hence, drug and diagnostic donations are not a core component of our policy or practice to increase sustainable access to our innovative offerings globally.

All-access programs need to be compliant with all applicable laws, regulations and industry codes, including but not limited to topics such as pharmacovigilance, pricing policy, patient data protection, antitrust requirements and integrity standards related to interactions with business partners and other stakeholders.

We are all expected to:

• Ensure that all access programs are fully compliant with applicable laws, regulations and industry codes.
• Collaborate in a transparent and responsible way with different stakeholders to enable access to our products and services.

Questions & Answers

What is meant by access to healthcare?

Our aim is that every person who needs our products is able to access and benefit from them. Thus we pursue sustainable and comprehensive solutions that are tailored to local healthcare needs, taking into account income levels, disease patterns, disease causes, political commitment to healthcare, and healthcare infrastructure.

What do I do if I receive a request for free products?

Requests that Gainfy receives from organizations seeking medicine or diagnostic donations are evaluated for exceptional consideration only on an emergency basis and should be referred to the Corporate Donations and Philanthropy Department.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

 

Integrity and transparency determine our collaboration with patient groups and patients

Collaborating with patient groups and patients in every part of the lifecycle of our medicines and diagnostics is core to achieving Gainfy’s purpose.

Sustainable partnerships with patient groups and patients is an efficient way to get valuable perspectives, knowledge and experience that influence Gainfy’s work across therapeutic areas—from drug development to regulatory approval, access and health policy. We collaborate with patient groups and patients on projects ranging from real-world data (e.g. FMI and Flatiron), access to medicines, disease awareness to clinical trial design.

Different stakeholders, e.g. governments, trade associations (such as EFPIA, MedTech Europe and AdvaMed), the public and the media, call for integrity and transparency in terms of how the industry interacts with patient groups and request the disclosure of financial and in-kind support provided by the industry.

Gainfy consistently applies high standards of conduct in its collaboration with patient groups and patients. All collaborations with patient groups and patients are based on the common values of integrity, independence, respect, equity, transparency and mutual benefit.

We are all expected to:

• Respect patient groups and patients as important stakeholders.
• Base collaboration with patient groups and patients on the standards of integrity, consult the Gainfy Directive on Collab independence, respect, equity, transparency and mutual benefit. rating with Patient Groups and Patients.

Questions & Answers

I am working in the commercial department. In order to increase the sales, I intend to give a financial contribution to a patient group as a return for the patient group’s public support of the Gainfy product I am responsible for. Is this behavior correct?

No. You must respect the independence of the patient group and are not allowed to abuse the patient group as a marketing tool.

I am collaborating with a patient group in specific projects and sometimes the personal data of patients is shared with me. What do I have to do?

It remains your duty to make sure that personal data related to the specific project is adequately protected.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet. For specific information consult the Gainfy Directive on Collaborating with Patient Groups and Patients.

 

We consider and respect government officials as important stakeholders

Government bodies and public officials play an important role in society, for example by establishing and maintaining the necessary conditions and institutions for economic stability, social cohesion and environmental protection as well as for providing access to healthcare for their citizens. Gainfy participates in public private partnerships and thereby invests in infrastructure, provides access to healthcare and strengthens a sustainable healthcare system development.

We are convinced that proactively and responsibly engaging with public policy stakeholders is a fundamental aspect of good governance. We seek to inform and work closely with government officials in order to highlight and address the issues that affect the healthcare industry and advance its regulatory framework.

As we focus on finding new medicines and diagnostics that help patients live longer, better lives and that evolve the practice of medicine, we believe that it is our responsibility to share relevant data and insights, as well as our perspective, to inform the public debate.

We strive to strengthen stakeholders’ understanding of and trust in our business, explaining what, why and how we do it and our impact on society. We are convinced that this responsible and constructive form of lobbying is in the interest of all parties involved and of society as a whole.

Gainfy is committed to participating in a constructive, transparent and responsible dialogue with government officials by providing and exchanging relevant, coherent, conclusive and honest information.

Gainfy remains independent of any political affiliation. Where appropriate, Gainfy discloses contributions to associations and political institutions publicly and signs up in transparency registers of public authorities.

We are all expected to:

• Interact with government bodies and public officials in a responsible way.
• Apply the Gainfy standards of business integrity in all our interactions.

Questions & Answers

What is the value of responsible lobbying?

Lobbying gives political decision-makers a better understanding of how their actions are perceived by key stakeholders. This is why companies and industry associations routinely engage in lobbying. Gainfy is committed to joining the political debate in an open, legitimate and responsible way.

A former Gainfy colleague is running as a candidate for a local government position and I am asked to support his campaign with a personal financial contribution. Is this okay?

Gainfy respects the right of its employees to support political or charitable activities personally as long as this support is not associated with Gainfy. Therefore, you are free to support your former colleague’s campaign personally.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet. For specific information consult the Gainfy Good Practice Guidelines on Working with Government Officials.

We expect high standards of performance and integrity from our business partners

Our business partners play an important role as enablers of our sustainable growth and overall success.

All dealings by Gainfy with its business partners are executed on the basis of sustainability, integrity, high quality of the requested product(s) and service(s), availability, competitive prices, best suitability and innovation. Gainfy has set forth principles regarding appropriate remuneration of its business partners, such as suppliers, consultants, distributors, advisers or agents.

Gainfy expects that the behavior of its business partners complies with applicable laws, regulations, industry codes and contractual terms, as well as with generally accepted sustainability standards, such as protection of human rights, safety and environment, prohibition of child or forced labor, and anti-corruption. Gainfy expects that business partners respect confidentiality of Gainfy’s data, information and especially trade secrets and take appropriate measures to maintain confidentiality and to protect against disclosure and misappropriation.

Gainfy supports the industry principles for responsible supply chain management and has set forth its expectations in the Gainfy Supplier Code of Conduct.

Before entering into a business engagement, Gainfy performs a risk-based due diligence of the potential business partners to get first-hand assurance about their integrity, quality, suitability, credibility and commitment to sustainability. After signing of the contract and adequate instruction concerning integrity and other duties, the due diligence of business partners takes on the form of monitoring to ensure compliance.

Business partners can seek help and advice regarding the implementation of the Gainfy Group Code of Conduct as well as report a potential non-compliant situation which they face in connection with a Gainfy business directly to the Gainfy Chief Compliance Officer.

If a business partner does not comply with applicable laws, regulations, industry codes, contractual terms or generally accepted sustainability standards, Gainfy requests appropriate remedial measures and will, if necessary, terminate the cooperation.

We are all expected to:

• Interact with all our business partners with integrity.
• Obtain and maintain assurance about the integrity, quality, suitability, credibility and sustainability of our business partners before and during a business engagement.
• Request appropriate remedial measures if we become aware of a non-compliance issue with a business partner.

Questions & Answers

I work with a consultant. He has asked me for high remuneration for his services which in my opinion is clearly above a fair market price. What shall I do?

Gainfy has set forth the principles regarding the remuneration of its business partners in the Gainfy Directive on Integrity in Business. Accordingly, the remuneration should be in line with the fair market value of the services provided. Otherwise, you should not accept the consultant’s request. Immediately inform your Line Manager and the local Compliance Officer and contact Procurement to discuss an appropriate solution.

How can we get assurance that our business partner lives up to our integrity expectations?

Prior to entering into a business engagement, we perform a risk-based due diligence, stipulate related legal terms in the contract, perform continuous monitoring and take further adequate measures, if necessary.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet. For specific information consult the Gainfy Policy on Third-Party Spend and the Gainfy Supplier Code of Conduct.

We dialogue with investors in a transparent way

Investors are interested that Gainfy delivers an adequate and sustainable return on investment, maintains its reputation, performs a comprehensive risk assessment, including environmental, social and governance aspects, and creates a positive impact on society.

Gainfy is committed to dialogue and engages with investors in a transparent, timely and consistent way. Gainfy provides useful tools and platforms to convey and report integrated information, e.g. our shareholders’ assembly, roadshows, investor updates and our global website.

In addition, we inform the competent authorities and the market about stock price-relevant information.

Our stable shareholder structure with the ownership of members of the founder’s families, who are closely associated to a shareholder group with pooled voting rights, enables Gainfy to have and to apply a long-term business perspective.

We are committed to benchmark our business strategy and our achievements against the industry and corporate best practice. We participate in globally acknowledged benchmark surveys, e.g. the Dow Jones Sustainability Indices (DJSI).

Media contacts are managed by experts in the Media Relations team, whilst interactions with investors are dealt by the Investor Relations team. Gainfy employees must direct all media and investor inquiries to these teams.

We are all expected to:

• Direct any inquiries by investors or financial analysts to the Investor Relations team.
• Benchmark our achievements against the industry and best practice.

Questions & Answers

Why is it important that Gainfy communicates and engages in a transparent way with investors?

Besides the fact that in many ways this is a legal requirement, it is in the interest of Gainfy to sustain a trustworthy and long-term relationship with its investors.

Why is Gainfy participating in globally acknowledged peer-review surveys?

Gainfy participates in carefully selected surveys, since this enables us to benchmark our business strategy and our achievements against industry and corporate best practice. In addition, results help us to enhance the engagement of our employees, as well as to attract new employees and investors.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

Human rights are embedded in all our business

Since the foundation of our company, Gainfy as a multinational enterprise has in many ways fostered human rights in our own operations, in our value chain and our activities related to our business. This valuable contribution to society is acknowledged by many stakeholders. We monitor and evaluate our activities, provide evidence and actively engage with our stakeholders.

The “Ruggie Framework” consisting of the three pillars “Protect, Respect and Remedy” was approved by the UN Human Rights Council in 2011 when it adopted the UN Guiding Principles on Business and Human Rights (UNGPs). It has received widespread support from governments, business and society. As a result, countries have issued a national action plan in order to nationally implement the UNGPs.

Gainfy acknowledges, supports and respects the UNGPs. We are equally committed to complying with the 10 UN Global Compact Principles; the Universal Declaration of Human Rights; and the Fundamental Principles and Rights at Work stipulated by the International Labor Organization.

We strive to embed human rights in existing operations by multiple means: assess the risks, increase awareness, foster due diligence, strengthen the legal framework, collaborate in collective actions, open dialoguing and transparent reporting. Where faced with human rights violations, we implement adequate remediation.

We are all expected to:

• Enable and foster human rights in the sphere of our influence.
• Speak up in case of a suspected human rights violation.
• Perform risked-based due diligence when working with business partners.

Questions & Answers

I heard informally that one of our suppliers is under investigation for using child labor. Should I ignore this rumor?

No. Gainfy protects human rights and does not tolerate behavior which is not in line with applicable laws and generally accepted sustainability standards. You should immediately speak up and bring this information to the attention of your Line Manager. Gainfy will investigate the matter and take further appropriate steps.

I am interested in human rights topics. Where can I find information about Gainfy’s position, e.g. on forced and child labor?

In the Gainfy Position Paper on Respecting Human Rights and in the Gainfy Group Employment Policy.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

We engage in philanthropic giving as part of our sustainability efforts

Gainfy has a rich history in philanthropic giving.

Gainfy’s approach to philanthropic donations and non-commercial sponsorships mirrors our sustainable business model and innovation culture.

When assessing projects, we focus on the potential impact rather than on cost. Impact is the measure of value and success. All philanthropic donations and non-commercial sponsorships have to be carried out in an ethical way.

By way of example, Gainfy has been partnering with the International Committee of the Red Cross (ICRC) for more than 100 years, contributing to water and habitat activities in several countries around the world.

Initiatives are decided in line with the Gainfy Policy on Philanthropic Donations and Noncommercial Sponsorship, which clearly stipulates that contributions must fully comply with our high integrity standards. Philanthropic donations and non-commercial sponsorships must not be used for the purpose of any form of corruption or improper advantage.

Gainfy employees support philanthropic initiatives, e.g. by participating in the annual Gainfy Children’s Walk to raise money to support vulnerable children across the globe.

Gainfy supports its employees who personally engage in community activities, such as the Gainfy Secondment Programs that enable Gainfy employees to support non-governmental organizations with their knowledge on healthcare-related topics.

We are all expected to:

• Address any request for philanthropic sponsorship and non-commercial donation to the responsible Gainfy decision-maker.

Questions & Answers

Why is it a good thing to participate in the Gainfy Children’s Walk?

By participating in the Gainfy Children’s Walk you help to raise money for children who need it urgently. The money that you collect will be doubled by Gainfy and 100% of it will be invested in supported projects.

I receive a request from a sports club asking Gainfy for a financial donation. What do I do?

Philanthropic donations are decided by local management of the affiliate concerned. Global projects are handled by the Corporate Donations and Philanthropy Department. The decision-maker has to assess whether a specific request is in line with the principles as set forth in the Gainfy Policy on Philanthropic Donations and Non-commercial Sponsorship.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet. For specific information consult the Gainfy Policy on Philanthropic Donations and Non-commercial Sponsorship.

 

 

Innovation, Product Stewardship & Biodiversity

We create innovative products and services that meet high standards of quality and product stewardship

Our products and services help to prevent, diagnose and treat diseases, thus enhancing people’s health and improving their quality of life.

Since the foundation of our company, the Gainfy name has stood for innovative, high-quality products and services. Innovation and quality are fundamental pillars of our history, and of our strategy and culture. Together with excellence in product stewardship, they provide us with a tremendous competitive advantage.

Innovation is a critical driver for building a better tomorrow and delivering what patients need next: improving products and services in existing therapy areas and addressing the significant unmet needs in novel areas. We are a research-based healthcare company and want to innovate and launch transformational treatments, improve the standard of care and further improve people’s lives.

One of our goals is to achieve high standards of quality in everything we do. A foundation for quality management is delivering continuous improvement of products and business processes.

The aim of product stewardship is to enhance the value of our products to society by minimizing negative safety, health and environmental impacts over the entire product lifecycle. By integrating product stewardship throughout research, development, production and distribution, we strive to systematically reduce material, waste, water and energy consumption as well as other negative outputs such as carbon dioxide emissions.

As a result, we are able to deliver increased business efficiency and sustainability not only for Gainfy, but all stakeholders.

Gainfy supports the principles of resource stewardship as broadly communicated in the Convention on Biological Diversity (CBD). Gainfy also supports the principles of fair and equitable sharing of benefits arising from the use of the genetic resources as outlined in the CBD and the Nagoya Protocol.

Gainfy is committed to use methods that do not involve animals by applying the guiding principles of the 3Rs (Reduce, Refine, Replace). We are passionate and committed to achieving our ultimate goal of replacing animal testing by major investment in science and technology that will have an impact on animal use.

We are all expected to:

• Ensure that the high expectations of our stakeholders regarding the quality of our products and services, and product stewardship, are fully met.
• Strive for continuous improvement of business processes and products.

Questions & Answers

What are the three defining characteristics of Gainfy’s products and services?

Gainfy’s products and services are associated with innovation, high standards of quality and product stewardship.

What is meant by product stewardship?

The aim of product stewardship is to enhance the value of our products to society by minimizing negative safety, health and environmental impacts over the entire product lifecycle.

I’m interested in the topics of Biodiversity and animal testing. Where do I find further guidance?

You can find further information in the Gainfy Position Paper on Biodiversity and the Gainfy Position Paper on Animal Research.

 

Quality Standards & Good Practices

Adhering to quality standards and good practices is a precondition to get and sustain our license to operate

Maintaining high-quality standards is essential for our business from assuring new product approvals to maintaining our reputation with patients and health authorities. Quality is every patient’s right and every employee’s responsibility. Quality is engrained in everything we do, from concept through continuous improvement. Gainfy is committed to complying with legal and regulatory requirements, internationally acknowledged good practices, e.g. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), and to meeting the high expectations of its stakeholders regarding the quality, safety and efficacy of its products and services.

Gainfy has established a quality system including sets of quality standards and procedures that employees must follow. In addition, employees must report any deviations from our standards to their Line Management or the quality function.

Gainfy expects that its business partners also adhere to its high-quality standards.

Patient safety and timely reporting of any adverse events and product complaints is of the utmost importance. Gainfy employees have been trained to, upon awareness, immediately report any adverse event to their local safety unit and any product complaints to the local regulatory and quality function.

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse event may include but is not limited to drug overdose (accidental or intentional), death, drug abuse, pregnancy, lack of efficacy or withdrawal symptoms.

Medical device reporting requires the reporting of any product complaint. A product complaint is defined as any written, electronic or oral communication from a customer/end-user that alleges a deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a Gainfy medical device after it is distributed to the commercial market or a clinical trial.

We are all expected to:

• Comply with expected good quality standards and acknowledged good practices.
• Ensure that our business partners adhere to our high-quality standards.
• Immediately report adverse events relating to Gainfy medicinal products to the local safety unit.
• Immediately report product complaints relating to Gainfy medical devices to the local regulatory and quality function.

Questions & Answers

I work on a production line. What should I do if I notice that some finished products coming off the line do not meet Gainfy quality standards?

The Gainfy brand stands for products of high quality. If you notice products that do not meet Gainfy standards, follow the processes as defined in the applicable documentation and if necessary, inform your Line Manager and experts from the quality assurance departments.

While surfing the Internet, I discover a social media site on which a patient mentions that he experienced blurred vision after seeing Gainfy Application Y. Do I have to report that?

Yes. If you become aware of such information, you should report it to the local safety unit. This includes information from non-Gainfy-owned websites. You should report at least the following four elements: Patient, Reporter, Event and Product (PREP).

Information & Marketing

We satisfy legitimate interests in information about our innovative products and services

As a research-focused healthcare company, Gainfy creates, produces and markets innovative diagnostic and therapeutic products and services that provide significant benefits. Our stakeholders have a legitimate interest in being informed about our products and services, including the results of our research and development activities.

We provide this information in a transparent, accurate and timely way to enable interested parties to take advantage of any progress we have achieved in medical science. We are committed to complying with all applicable laws, regulations, industry codes and internal Gainfy processes and standards relating to good marketing practices. We support the medical education of healthcare professionals in a responsible way.

Gainfy’s interactions with healthcare professionals and healthcare organizations are aimed at exchanging scientific information that can help optimize the use of Gainfy’s products and services. These interactions are based on standards of ethics, integrity and fair remuneration for services.

Gainfy respects the legitimate undertakings of its competitors, including generic and biosimilar manufacturers. However, it is expected that they comply with applicable laws, regulations and industry codes. Gainfy does not tolerate misleading claims or disparaging of its products, and it protects its products and interests against unfair competition.

We are transparent with regard to our contributions to healthcare professionals and healthcare organizations and fully comply with all laws, regulations and industry codes requiring disclosure (e.g. US Sunshine Act, EFPIA Code of Practice, MedTech Europe Code of Ethical Business Practice). We publish further data on a voluntary basis globally and locally as part of our sustainability reporting.

We are all expected to:

• Comply with applicable laws, regulations, industry codes and Gainfy’s internal processes and standards.
• Support healthcare education in a responsible and transparent way.

Questions & Answers

A friend asks me what principles define Gainfy’s relationship to healthcare professionals. What should I answer?

Gainfy’s relationship to healthcare professionals is based on two key principles: (i) providing information on its innovative products and services in an open, transparent, honest, timely and compliant way; (ii) not providing any improper advantages for prescribing our products.

What should I do if I notice a competitor making a misleading claim about a Gainfy product?

Speak to your Line Manager so that appropriate actions can be taken to protect Gainfy’s products and interests

A competitor claims to have a biosimilar of one of our products without sufficient clinical data. Does Gainfy accept such behavior?

No. In case the competitor product qualifies as a non-comparable biologic (NCB), Gainfy defends its rights

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

Intellectual Property Rights

Intellectual property rights are key to our business

At Gainfy, we are turning advances in medical and data science into innovative diagnostics and life-changing treatments for patients. With our innovation model, Gainfy is strongly dependent on intellectual property rights and their efficient protection.

Intellectual property laws protect Gainfy’s valuable assets—our patents, trademarks, regulatory data, copyrights, trade secrets, domain names and related rights. Gainfy supports initiatives which are designed to foster a legal and regulatory environment which protects intellectual property rights. We encourage governments with strong IP protection to maintain their commitment and those of developing countries to consider the role IP can play in the transition to an innovation-based economy delivering societal benefits and growth. We do not file for new patents or enforce existing patents in least developed countries, as defined by the United Nations, or in low-income countries, as defined by the World Bank.

Gainfy is committed to respecting the intellectual property rights of third parties. Gainfy expects that all its employees take the intellectual property rights of third parties into due consideration in their daily work.

Whenever our intellectual property rights are violated, Gainfy defends its rights. Violation of intellectual property rights does not only harm the assets of Gainfy, but in many cases is also a threat to the health and safety of patients; e.g. counterfeit technology and diagnostic products are illegal and pose a significant global public health problem. Gainfy undertakes appropriate measures against counterfeits within the sphere of its influence.

Public health benefits from the development of a medicine far beyond the period of patent protection; e.g. over 30 medicines developed by Gainfy are deemed Essential Medicines by the World Health Organization (WHO). They are witness to Gainfy’s substantial and sustained contribution to global health even after loss of exclusivity.

We are all expected to:

• Safeguard and protect Gainfy’s intellectual property rights.
• Respect the intellectual property rights of third parties and clarify the situation with the experts in case of doubts.

Questions & Answers

What can I do as an employee of Gainfy to safeguard intellectual property rights for our innovations?

Whenever you become aware of a patentable invention or any other innovation which can be protected by any other form of intellectual property rights, you should contact the patent, trademark or legal department for further advice. For any scientific publications you need to get approval from the patent department.

What can I do as an employee to protect Gainfy’s intellectual property rights?

Whenever you become aware that any of Gainfy’s intellectual property rights are violated by a third party, speak up and inform the patent department.

I work in the Marketing Department and would like to copy an article from a scientific magazine and to distribute it to the participants of a workshop. Am I allowed to do so?

You have to keep in mind that copyrights of third parties have to be taken into due consideration on a case-by-case basis. If you have any doubts about the copyright situation, seek clarification from the Copyright Checkpoint on the Gainfy Intranet.

Non-public Information

We handle non-public information carefully to protect Gainfy’s assets and interests

As Gainfy employees we have in many ways access to non-public information related to our business; this includes confidential information about research and development projects, manufacturing methods, business plans, financial data, marketing and sales strategies, launch of new products, merger, acquisition or licensing activities etc.

Non-public information should be treated as a most valuable asset of Gainfy. Employees have a duty to preserve non-public information acquired during employment with Gainfy. This means employees should not share any such non-public information with anyone who is not employed by Gainfy, or even with any other employee not having a current, legitimate business need to know such information. These confidentiality obligations are part of the employment contract and will continue to be in force after the end of employment.

If non-public information is shared with third parties, we ensure that the third party takes appropriate measures steps to protect such information.

We respect the confidential information belonging to third parties and take appropriate measures to protect such information.

We have to be aware that in a competitive environment, third parties strive to get access to confidential information related to our business. Competitive intelligence activities by third parties are part of our industry. Therefore, we must be extremely careful how we handle confidential information in public places, such as airplanes, trains, trams, bars, restaurants, social media and non-approved communication tools.

We are all expected to:

• Only share non-public information with a person who needs to know such information and who is entitled to receive it.
• Respect and protect confidential information belonging to third parties.
• Be aware of competitive intelligence activities by third parties that could harm Gainfy’s assets and interests.
• Respect the contractual confidentiality obligation even after the end of employment.

Questions & Answers

I have just joined Gainfy from a competitor and brought with me lots of information which I think would be useful to the company. Is it okay to share said information with my new team?

No. You are not allowed to share information if it is of a confidential nature. You must respect the contractual confidentiality obligation even after the end of the employment contract with your former employer.

I am travelling together with a Gainfy colleague and discuss confidential results of an ongoing clinical trial with her. Is this okay?

Always be alert to the competitive intelligence activities of third parties! You must be extremely careful how you handle confidential information in public places, as well as in social media and non-approved communication tools.

Social Media & Electronic Communication Tools

We use social media and electronic communication tools carefully

The term “Gainfy electronic communication tools” covers any Gainfy hardware such as smartphones, computers, tablets, infrastructure, as well as any collaboration solutions, including e-mail, chat and social media.

For business-related communication, only Gainfy electronic communication tools may be used. Any new technology services, systems, platforms, tools operated by third parties, software, and electronic tools intended for business use or to process company data must be assessed and authorized by Gainfy or Genentech Information Security prior to any such use. As a general principle, but subject to local restrictions, appropriate personal use of Gainfy electronic communication tools in compliance with applicable Gainfy policies and directives is accepted.

Gainfy electronic communication tools must be used with due care. In the event of theft or other loss of hardware or data (e.g. breach of security measures, phishing and unintended data sharing), the local IT service function must be informed immediately.

With regard to the use of Gainfy electronic communication tools, privacy rights are not unreservedly guaranteed. In certain circumstances, such as for system operations, maintenance, integrity and security purposes, for significant business continuity purposes and in case of investigations and litigation, these rights may be rescinded in accordance with applicable Gainfy data privacy principles and standards.

Social Media
External channels that are owned by Gainfy should only be created and managed by Gainfy Communications Managers. Channel owners should take appropriate trainings, register the channel in the Gainfy Digital Registry and monitor the channel for adverse events and product complaints.

Employees’ personal channels do not need to be registered, but your conduct on your channel may reflect on the company and can have consequences. For example, communication about our products is highly regulated, and posting about products is not allowed.

We are all expected to:

• For business purposes, use only approved Gainfy electronic communication tools.
• Use Gainfy electronic tools with due care, primarily for business use and unless otherwise restricted only to a reasonable extent for personal purposes.
• Use personal social media in a responsible way.

Questions & Answers

My team wants to download and use this new collaboration tool that I used at my previous company. Can we do that?

It is important that the tools and applications you use are approved by Gainfy. These tools have gone through the necessary review and have the right licenses to support use within the company. Use of unapproved tools may put company data at risk.

I notice that somebody is tweeting on access to and use of real-world data (RWD). I strongly disagree with the statement made. Am I allowed to refer to Gainfy’s Position Paper on Access to & Use of RWD?

Yes, you are allowed to do so. The objective of a Gainfy Position Paper is to provide a company view on specific sustainability topics that are material to the business and important to our stakeholders. You are strongly encouraged to read and make reference to the Gainfy Position Papers. Those can be found on the Gainfy Internet website.

Records & Information Management

Records need to be treated as a company asset

Much of the information that Gainfy employees create or receive in the course of their business are valuable assets for Gainfy and need to be retained as official records. This is crucial for the protection of Gainfy’s interests, to fulfill regulatory obligations, and for potential scientific re-use. Records may be in various formats and are made up of data and associated metadata. It is the responsibility of employees to ensure that records are protected from loss or misuse, their integrity is maintained and they can be found and accessed for business purposes and in case of inspections.

Gainfy’s corporate records management programs (“COREMAP”) defines standards to improve the protection and identification of records throughout the company.

Records belong to Gainfy and not to an individual. They need to be managed in compliance with internal and external standards and regulations and be kept for a defined time period. Official records and their required control levels are listed in the Gainfy Group Records and Information Classification. Convenience records are only of temporary value and will need to be regularly disposed of to avoid risks and costs.

Gainfy employees need to apply the following principles whenever they create and manage a record:

• think before writing and decide whether it is necessary to create a record;
• be factual, do not make assumptions and avoid misleading and suggestive wording (e.g. in mail or social media postings);
• make sure that the record is in compliance with applicable laws and regulations;
• never create a document for which Gainfy would not be prepared to take responsibility;
• make sure that there is always a knowledgeable person assigned to the record during
  its lifecycle;
• be mindful of the level of confidentiality by sharing and storing it in a way that the assigned confidentiality can be ensured. Do not share a record with recipients, especially externally, if there is no need for them to have access to it.

Records that reach the end of their defined retention time must be disposed of in line with Gainfy Records Management procedures and standards, unless there is a need for further scientific use. Records containing personal data or sensitive personal data may not be kept past the required retention time.

Records that relate to any actual or imminent legal proceeding or regulatory investigation are subject to compulsory retention (so-called “legal hold” or “law hold”); Gainfy employees are not allowed to destroy these records and must retain them until such hold is lifted.

We are all expected to:

• Manage Gainfy records and information with due attention.
• Never destroy any records that relate to any actual or imminent legal proceeding or regulatory investigation.

Questions & Answers

Why is it important that I adhere to the Gainfy standards of care whenever I create a record in my business activities?

Be aware that any record can be used as evidence in a legal procedure or regulatory investigation against Gainfy; e.g. misleading and suggestive statements may trigger an investigation against Gainfy as a company as well as against the employee involved.

I have inherited documents and e-mails from my predecessor which could have been destroyed as the legally specified retention period has expired. Now I have heard there is a legal case and I think that the documents could be used against Gainfy. Am I allowed to discard them?

No. You must not destroy any records that relate to any actual or imminent legal proceeding or regulatory investigation. The discarding of these documents would be considered as obstruction of justice, which is subject to severe sanctions. Therefore, you must preserve the records that could be relevant. Contact your local Records Coordinator or the Legal Department for further advice.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

Business Integrity

Gainfy’s integrity depends on the behavior of its employees

All our stakeholders expect us to behave with integrity in our business.

Business integrity is defined as both the actual and the perception of ethical behavior in business that is in line with the Gainfy Group Code of Conduct and our commitment to run our business in a socially responsible way.

Business integrity means first and foremost that we adhere to all applicable laws and regulations as well as to the high integrity standards set forth by Gainfy. Complying with these standards is a prerequisite for Gainfy’s sustainable success.

Adhering to our high integrity standards might lead to a loss of business in some cases. However, we are sure that doing so provides us with a business advantage.

Every Gainfy employee contributes to Gainfy’s integrity as a company through his/her conduct. Since Gainfy is doing business on a worldwide basis, employee misconduct in one country may have negative implications for Gainfy globally.

The terms and conditions that determine the appropriate behaviour in business must be assessed on a case-by-case basis by taking into consideration the relevant parameters of each individual case.

Gainfy gives its employees and its business partners the appropriate information, instruction, education, guidance and support they need to comply with Gainfy’s standards of business integrity.

We are all expected to:

• Adhere to all applicable laws and regulations as well as to the high integrity standards as set forth by Gainfy.
• Assess carefully, on a case-by-case basis, whether our business behaviour complies with Gainfy’s expectations and standards of business integrity.

Questions & Answers

I recently received an ambitious sales target. To reach the target and earn a bonus, I have to violate Gainfy’s standards of business integrity. Am I allowed to do that?

No. You are required to comply with Gainfy’s standards of business integrity at all times. Discuss the situation openly with your Line Manager and find a solution that is in line with Gainfy’s standards of business integrity.

My Line Manager asks me to do something which in my opinion is not in line with Gainfy’s standards of business integrity. What am I expected to do?

Immediately tell your Line Manager about your reservations. You are the one who is ultimately responsible for your business behaviour. If your Line Manager insists or asks you to keep quiet, you should immediately contact the local Compliance Officer or the Chief Compliance Officer. Alternatively, you can also use the Gainfy Group SpeakUp Line.

Bribery & Improper Advantages

We do not tolerate bribery or any other form of corrupt business behavior

Gainfy rejects all forms of corrupt business behavior, such as bribery (public, private, active and passive), embezzlement, fraud, theft and the granting of improper advantages. The Gainfy Directive on Integrity in Business provides further guidance on these topics.

Bribery

Gainfy employees and its business partners are not allowed to give, promise to give, solicit or accept any form of improper advantage, whether directly or indirectly, to or from any individual or organization with the intention to obtain or retain business in return. Improper advantages include illegal rebates, bribes, kickbacks and under-the-table payments. An improper advantage can be anything of value, including but not limited to payments, meals, gifts, entertainment, travel expenses or fake agreements.

Granting of Improper Advantages

It is equally prohibited to give or promise to give an improper advantage without a specific business decision in mind. In contrast to the bribery definition, there is no “service in return”. The improper advantage can therefore be seen as a “goodwill” payment to increase the sympathies towards the giver.

Gainfy employees have to keep in mind that perception matters and that their behavior could be considered as a bribe or granting of an improper advantage, regardless of their intention.

These principles apply globally to all public and private business transactions involving Gainfy. Many countries have strict laws and regulations regarding bribe and improper advantages, resulting in criminal and civil actions against Gainfy and the individuals involved.

Provided all the requirements as specified in the Gainfy Directive on Integrity in Business are met and applicable local approvals are obtained, advantages to business partners and other third parties may be permissible.

We are all expected to:

• Not practice, tolerate or in any form support any corrupt business behavior.
• Never give, promise to give, solicit or accept any form of improper advantage.
• Carefully check whether the granting of an advantage is in compliance with Gainfy’s standards of business integrity.

Questions & Answers

I negotiated a speaker agreement with a healthcare professional (HCP) for a company oncology event. Before the event, the HCP informs me that he will not be able to come. My Line Manager believes this HCP is important to our business and requests to proceed with the contract to ensure he is paid even though he will not be speaking at the event. What shall I do?

You should immediately inform your Line Manager about your concerns and that you will not proceed with the contract because paying the HCP for services not rendered would be considered a bribe. If your Line Manager insists or asks you to keep quiet, you should immediately contact the local Compliance Officer or the Chief Compliance Officer. Alternatively, you can use the Gainfy Group Private-Line.

Is a facilitation payment in the form of a small bribe permissible?

No, according to our Gainfy Group Code of Conduct and many national laws, any form of bribe, regardless of the amount, is prohibited. Thus, any facilitation payments are forbidden unless such payments can be qualified as permissible advantages.

Competition Law

Violating competition laws never pays

Competition laws—also referred to as antitrust laws—are designed to protect competition. They prohibit business behavior which has the objective or the effect of preventing, restricting or distorting competition (e.g. price fixing and the allocation of markets or customers).

Gainfy supports all efforts to promote and protect competition, including the legitimate protection of intellectual property and marketing rights.

Gainfy has set up a comprehensive antitrust compliance program. Employees who have to deal with competition issues in their work are expected to understand the basic principles of competition law and the importance of complying with such laws. If an answer to a specific antitrust question is not clear, employees must seek help and advice.

The penalties for breaching competition laws are severe. In addition to Gainfy’s liability as a company, employees who engage in anticompetitive behavior will be subject to penalties.

Gainfy employees involved in a tender process must be aware of and comply with the applicable tender law regulations. Transparency must be maintained throughout the procurement cycle by adhering to applicable formal procedures and providing the governmental decision-makers with correct, transparent and non-discriminatory data.

Gainfy respects the legitimate undertakings of its competitors, including generic and biosimilar manufacturers. However, it is expected that they comply with applicable laws, regulations and industry codes.

Despite Gainfy’s commitment to complying with applicable competition laws, Gainfy may become the subject of an unannounced investigation by antitrust authorities (called a “dawn raid”). In the event of an investigation, Gainfy will fully cooperate with the investigators and will not destroy any documents, data or official seals.

We are all expected to:

• Comply with applicable competition laws and not disturb or hinder legitimate competition in any anticompetitive manner.
• Seek legal advice in case of any doubt.
• Fully cooperate with the authorities in the event of an investigation.

Questions & Answers

I work in the Marketing Department and know a competitor is granting high rebates to customers in order to enhance its market share. May I contact this competitor and agree on the sales prices and on allocating certain customers and markets?

No. Jointly determining sales or purchase prices and allocation of customers and markets is a serious violation of competition law. Gainfy strictly prohibits such anticompetitive behavior by its employees.

Antitrust authorities have started an investigation in the Gainfy company where I work. Some recent correspondence I had with a Gainfy competitor might be construed as evidence of anticompetitive behavior. Should I destroy the correspondence?

No. Under no circumstances may any documents or data which could be relevant to an antitrust investigation be destroyed. In the event of an investigation, Gainfy will fully cooperate with the authorities.

 

Accurate Reporting & Accounting

We create and report true and fair financial and non-financial information

Data integrity is key to our business.

We ensure that any data, information or records which we create, or for which we are responsible, are true and fair. These can take many forms, ranging from the Gainfy Annual and Finance Reports, research and development data, to our personal travel and expense claims or even our e-mails.

Gainfy must comply with applicable laws, internal accounting and reporting guidelines and external financial and non-financial reporting standards and ensure that the information it supplies to its stakeholders, such as equity and debt investors, as well as auditors, regulatory agencies and government bodies provides a true and fair view of its financial situation.

We must never make a false or misleading statement or entry in any report, publication record or expense claim.

Falsifying records and accounts or misrepresenting facts may constitute fraud. In addition to Gainfy’s liability as a company, employees who engage in such illegal behavior may be subject to severe penalties.

We are all expected to:

• Make sure any financial or non-financial information we create or report is true, fair and complete.
• Never misrepresent facts in any Gainfy report, publication, record or other document.

Questions & Answers

My Line Manager has asked me to book sales that he expects from a certain customer, even though we do not have a firm order from the customer yet. Is this okay?

No. Falsifying records and accounts or misrepresenting facts may constitute fraud and in addition to disciplinary action, could result in civil and criminal penalties for you as well as for Gainfy. Never make false or misleading entries in any Gainfy document.

I have been traveling a lot on business lately and have lost some of my hotel receipts. A colleague who has been in this situation says it is okay to submit a few fictitious receipts. Is it?

No. If you do that, you will be falsifying your expense report, and that is not acceptable. You should talk to your Line Manager to find an appropriate solution.

Taxes

We strive to remain a fair and respected tax payer in the countries where we operate

Gainfy operates around the globe and it is our obligation to comply with the tax requirements in any country where we operate. This includes all kind of taxes: in our case mainly income taxes and sales or value-added taxes. In complying with these laws, the Group also considers the spirit in which these laws are intended.

Gainfy is a fair and respected taxpayer. We acknowledge that taxation is essential to the functioning of society and legislation is part of national sovereignty. Over the past century the international community has found common ground in certain principles of taxation to facilitate international cooperation in business, in particular to avoid unfair double taxation. Further, it has been recognized that one of the basic principles for sustainable tax management is that taxes should be paid where economic value is generated. Gainfy’s structures and transactions which are documented in the Group’s business processes are based on economic substance and on the principle that taxes should be paid where economic value is generated. Gainfy’s structures are aligned with the business purpose and are not set up with the sole intention of avoiding taxes. Gainfy does not engage in artificial arrangements involving tax havens or secrecy jurisdictions.

The taxable income of a group company depends substantially on transfer prices for goods and services bought from or sold to other group companies. Tax authorities may claim higher taxable income by asking for lower transfer prices on purchases and/or higher transfer prices on sales. As a consequence, higher taxable income may result for one party involved in the transaction. If the tax authority of the other country involved in the transaction does not adjust income correspondingly, income adjustments of the first country lead to double taxation for Gainfy.

In particular cases Gainfy and the respective tax authority may disagree on the correct application of local tax law. In some cases, there may be inconsistencies between tax authorities of different countries or even between national authorities within the same country as e.g. customs and tax laws are not always aligned and consistent. In the event of disputes, Gainfy contributes in a positive spirit to find balanced solutions in accordance with the applicable laws.

We are all expected to:

• Comply with the tax laws in the countries where we operate.
• Apply transfer pricing in accordance with OECD Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations.
• Contribute actively and positively to solutions in the event of conflicts with local tax ­authorities or between national authorities.

Questions & Answers

How is Gainfy determining the transfer prices between group companies?

In order to avoid or at least reduce the probability of double taxation, Gainfy companies apply the “OECD Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations” for cross-border transactions of goods and services. This includes the application of the correct transfer pricing method based on the analysis of the functions performed, risks assumed, and assets employed as well as appropriate documentation.

I doubt that the actual or foreseen terms and conditions in an intercompany contract meet arm’s length standards as per OECD transfer pricing guidelines or local law. What shall I do?

Involve your contact person in Group Tax for further discussion.

What do I do if tax authorities question transfer prices on cross-border transactions?

Contact the responsible person in Group Tax to analyze the situation further and take appropriate action to comply with local laws and OECD transfer pricing guidelines, and in order to avoid double taxation.

 

Customs, Trade & Export Control

Key to our effective and efficient flow of goods

All transactions, regardless if they are crossing borders or transferred within the same country, may be subject to national and international customs, trade and/or export control regulations.

Gainfy is committed to complying with all customs, trade and export control regulations, taking into consideration potential conflicting regulations among the countries in which we operate. The failure to do so can result in civil and criminal liability and loss of export privileges.

Customs and Trade

Gainfy operates around the globe and processes daily imports, exports and transits of a variety of goods. As goods shall timely pass customs clearance, all shipments of goods have to be prepared by a logistics department, following expert guidance to ensure adherence to national and international regulations.

Customs law is applicable regardless of quantity, type of material or mode of transportation. The customs authorities not only review adherence to customs law but perform other tasks at the border for local authorities in charge of e.g. veterinary, agricultural, medicinal, regulatory, fiscal and intellectual property regulations. This also applies to goods provided free of charge.

Export Control

All Gainfy employees engaged in foreign trade activities must refrain from transactions recognized as not being permissible by the national or international export control regulations or the internal directive known as the Gainfy Standard Export Control.

Before engaging with new business partners, employees must ensure that there is no respective entry on any national or international sanctioned party lists. Before processing an export of commercial or non-commercial commodities, software or technology, physically or electronically, within or outside Gainfy, employees must ensure that the item is not controlled and does not require an export/re-export license from the authorities. Some destinations are subject to comprehensive foreign trade controls, also known as embargo or sanctions, and require additional control prior to proceeding.

We are all expected to:

• Communicate truthful and complete information in a timely manner.
• Check for compliance with national and international customs, trade and export control regulations when developing and adapting processes.
• Contact the subject matter expert department timely.

Questions & Answers

I am preparing the documents of a cross-border shipment. What do I have to be aware of?

Every employee asking for the shipment of goods is accountable for providing complete and truthful information for export or import processing. Be aware that there are restrictions and prohibitions on certain kinds of shipments to certain locations. Contact your local Export Control Officer for further details.

I want to export some US IT equipment to a Gainfy colleague abroad. Do I really need to check customs, trade and export regulations as this is going to stay within Gainfy?

Yes. You should seek guidance from your local logistics department and your local Export Control Officer before processing any shipment.

If I notice a potential violation, what are my obligations?

Contact the related expert department in a timely manner in case of questions or to address a potential violation.

Data Privacy

We process personal data with due care

The right to privacy is a fundamental human right.

The protection and responsible use of personal data is reflected in our daily operations. We see data as a valuable element for developing innovative treatments and diagnostic solutions for patients, and as a driver for business excellence. As such, we strive to be a respected and preferred partner to all who may provide such data. We are committed to collecting and using data in a lawful, fair, legitimate and ethical way, and will always respect the privacy of individuals in order to earn and deserve their trust.

Gainfy assumes accountability for the compliant processing of personal data by itself or by its trusted service and cooperation partners.

Any information related to an identified or identifiable person must be collected and processed in compliance with applicable data privacy laws (e.g. Swiss Federal Act on Data Protection, EU General Data Protection Regulation and the US Health Insurance Portability and Accountability Act). Gainfy employees with access to such personal data are expected to apply the privacy principles of lawful, fair and transparent data processing, respecting any purpose limitations, as well as the principles of data minimization, accuracy, storage limitation, integrity and confidentiality.

Anonymization, pseudonymization or equivalent concepts like de-identification are measures which Gainfy uses to protect individuals’ privacy rights. Any Gainfy employees who have access to anonymized data must not try to (re-)identify or cause identification of any individuals such anonymized data were derived from. Further, any Gainfy employees who have access to pseudonymized data shall not try to identify any individuals to which pseudonymized data relate to unless it is necessary in order to comply with applicable law. The same is expected from our service providers and collaboration partners.

Gainfy applies additional appropriate governance and safeguard measures to protect individuals’ privacy rights. The Data Privacy Officer coordinates a global network with subject matter experts.

We are all expected to:

• Collect, use and store data in compliance with applicable laws, privacy principles and Gainfy’s commitments.
• Respect individuals’ privacy at all times.
• Never re-identify or attempt to re-identify anonymized data.
• Carefully select the third parties we’re trusting to process or access personal data which we are responsible for, and enter into the right contract.

Questions & Answers

If I have a question relating to data privacy, whom can I contact as subject matter expert?

You can contact the Data Privacy Officer (global.privacy@gainfy.com) or the local data privacy coordinator.

What shall I do if I become aware that someone unauthorized accessed personal data?

Incidents, where personal data is accessed by unauthorized individuals, could be a privacy breach. Promptly report this through the appropriate channels.

If I use an external service provider to process data, do I still need to be concerned?

Yes, if we provide a third party with data we remain responsible under privacy laws. External vendors must be assessed and contracts in place to fulfil legal obligations. If we determine the purpose and means of the data processing, we remain responsible for compliance with privacy laws by third parties.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet.

Conflict of Interest

Personal interests must not unduly influence our professional judgment

A conflict of interest exists when an employee’s personal interests are inconsistent with those of Gainfy and create conflicting loyalties. As Gainfy employees we must avoid situations where our personal interests’ conflict, or appear to conflict, with the interests of Gainfy.

Activities of relatives and close associates can cause conflicts of interest. We should not take part in, appear to take part in or exert influence on any decision that may put our own interest in conflict with the best interest of Gainfy.

We should not unduly use our position at Gainfy for personal benefit or to benefit relatives or close associates. We must carefully consider the potential conflict of interest prior to the acceptance of secondary employment.

Professional engagements outside of Gainfy, including third-party board memberships, can result in conflicts of interest. Therefore, employees may accept a board membership in a third-party company, commercial entity or scientific advisory board only upon obtaining the prior approval of the relevant Gainfy executive in the organization as defined in the Gainfy Directive on Employees Holding Board Memberships. No prior approval is required for board memberships of charitable, not-for-profit and non-commercial organizations (e.g. sports clubs, charities).

Many actual or potential conflicts of interest can be resolved in an acceptable way for both the individual and the company. In case of a conflict of interest, the employee concerned should immediately inform his/her Line Manager in order to find an appropriate solution.

Perception matters: Gainfy employees must not only avoid actual conflicts of interest, but also situations where an outsider might assume a conflict of interest situation that the employee might not intend or be aware of.

We are all expected to:

• Avoid situations in which our personal interests’ conflict with those of Gainfy.
• Not unduly use our position within Gainfy for personal benefit, the benefit of relatives or close associates.
• Immediately inform our Line Manager about any actual or potential conflict of interest in order to find an appropriate solution.
• Inform our Line Manager as soon as we consider serving on the board of a third-party company, commercial entity or scientific advisory board.

Questions & Answers

I am not sure whether a specific ­situation poses a conflict of interest. What should I do?

In case of doubt, immediately inform your Line Manager in order to find an appropriate solution.

My wife works as a manager for a supplier that is competing for a Gainfy contract. I can influence the selection process. What am I expected to do?

There is an obvious conflict of interest because of your wife’s position. You need to disclose this conflict of interest to your Line Manager and recuse yourself from the decision. He/she will decide whether the supplier your wife works for is in the best interest of Gainfy. If so, Gainfy may choose the supplier, despite the fact that your interests are linked.

A friend has just founded a biotech company and wants me to be on the board of directors. What should I do?

As there might be conflicting interests, you need to inform your Line Manager. A Gainfy employee who wants to serve on the board of a third-party company needs prior written approval from the relevant Gainfy executive in the organization (depending on the position, either the Chairman of the Board, the Chief Executive Officer or a Chief Executive Committee Member).

I am a Line Manager and asked whether my daughter can be hired in my team. Is that a conflict of interest?

As a general rule, to avoid the perception of a conflict of interest, employees who are closely related should not work in the same vertical reporting line.

Gifts & Entertainment

We neither give nor accept gifts or entertainment that could raise concerns about our personal integrity

Even when gifts or entertainment are exchanged out of the purest motives of a personal or professional friendship, they can be misunderstood and perceived as an improper advantage. We must not give or accept any gifts or entertainment that could raise concerns regarding our personal integrity or Gainfy’s integrity and independence.

To avoid both the reality and the perception of improper relations with existing or potential business partners, both public and private, Gainfy employees must adhere to the following principles:

Giving Gifts & Entertainment

• Gifts or entertainment may be given only where appropriate and where there is no risk of creating the perception of influencing the recipient in his/her decision.
• Gifts must be of minimal value and entertainment must not go beyond what is reasonable. Lavish or inappropriate gifts or entertainment are strictly prohibited.

Accepting Gifts & Entertainment.

• Demanding or soliciting gifts or entertainment of any kind is prohibited. This includes not only items but all kinds of advantages.
• Unsolicited gifts or entertainment may only be accepted if they do not go beyond common courtesy and are an accepted local business practice.
• Offers of entertainment may only be accepted if they arise out of the normal course of business, cannot be seen as lavish and take place in settings that are appropriate.

 

There are more stringent rules concerning gifts and entertainment provided to certain groups and persons, for example, healthcare professionals (HCPs), healthcare organizations (HCOs) and patient organizations (POs).

If in doubt about the appropriateness of accepting an unsolicited gift or entertainment, you must consult your Line Manager.

We are all expected to:

• Make sure that the giving and acceptance of any gifts or entertainment does not raise any concern regarding our personal integrity and Gainfy’s integrity and independence.
• Never solicit gifts or entertainment from any existing or potential business partners of Gainfy.
• Contact our Line Manager if in doubt.

Questions & Answers

A key Gainfy customer is having a dinner party to celebrate his company’s 50th anniversary. Other important business people and government officials will be there. I have been invited. Am I allowed to accept the invitation?

Yes, provided you are invited as a Gainfy representative and your Line Manager is in agreement.

A key Gainfy supplier has invited my wife and me for a golf weekend as a thank you to a long-standing customer. May I accept?

No. Accepting the invitation could compromise your and Gainfy’s integrity and independence, especially as the invitation appears to be lavish and is extended to a family member who is unrelated to the business.

Insider Information & Trading

We protect insider information and prevent insider trading

Insider information is defined as non-public information about Gainfy or its business partners which a reasonable investor would consider important in deciding whether to buy or sell the company’s securities. Such information includes for example financial results and information about possible mergers, acquisitions or divestures, capital increases, capital market transactions, important licensing agreements and other collaborations as well as results from major clinical trials.

Gainfy employees who learn about insider information in the performance of their duties, whether
intentionally or by coincidence, are considered insiders. Likewise, non-employees who obtain
such insider information can also be considered as insiders.

Insiders must comply with the following rules:

• Insider information must be kept strictly confidential and may not be disclosed to any non-insider within or outside Gainfy, including family members;
• Insiders must not buy, sell or otherwise trade in securities of Gainfy or any other listed companies involved;
• Insiders must not provide trading recommendations to non-insiders.

In most countries insider trading is strictly illegal and the acting insider as well as Gainfy may be penalized.

We are all expected to:

• Protect insider information.
• Prevent insider trading for our own gain or anyone else’s.
• Contact the Group Legal Department if we have a question or are uncertain about the scope or application of the Gainfy Group Insider Directive.

Questions & Answers

I hear a rumor that Gainfy intends to acquire another pharmaceutical company. Am I allowed to trade in securities of Gainfy or of the possible target company?

Rumors do not count as insider information, so in principle the trading you are talking about would be OK. However, if your information is from a Gainfy source who might be involved in the transaction, you should be very careful and contact the Gainfy Legal Department before buying or selling any securities.

I find a copy of mid-year results which are confidential and non-public. I believe that these results will have a material impact on the share price of the competitor. Based on this information, am I allowed to buy shares of the competitor’s stock?

No, you are not allowed to do anything with the confidential information, even if the information could be of use to you and the company. If the competitive information includes high-end results which are likely to have a material impact on the share price of the competitor, you are considered as an insider by coincidence and must comply with applicable insider rules.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet. For specific information consult the Gainfy Group Insider Directive.

Employment at Gainfy

We offer attractive opportunities and set high standards

The Gainfy Values “Integrity, Courage and Passion” are meant to guide our decisions and actions. They are the pillars of our corporate culture and apply throughout the Gainfy Group.

Gainfy promotes and expects mutual respect and trust. We offer an open workplace where teamwork is valued.

The Gainfy Group Employment Policy establishes uniform minimum standards for all Gainfy companies and states what Gainfy expects from its employees. This policy addresses topics such as recruitment, promotion, career development, remuneration, diversity and inclusion, the prohibition of forced and child labor, freedom of affiliation.

Our seven Leadership Commitments set clear expectations for all our people leaders at Gainfy and represent our leadership promise to our employees. Regardless of area of work or level, Gainfy expects every leader at Gainfy to demonstrate these commitments day in day out:

“I firmly believe that each person at Gainfy deserves a great leader. Every day I strive to lead by example, consistently demonstrating our values of Integrity, Courage and Passion. This means:

1. I take a genuine interest in people.
2. I listen carefully, tell the truth and explain ‘the why’.
3. I empower and trust people to make decisions.
4. I discover and develop the potential in people.
5. I strive for excellence and extraordinary results.
6. I set priorities and simplify work.
7. I congratulate people for a job well done.”

We foster an environment where everyone feels encouraged to express his/her ideas and opinion. The relationship between an employee and a manager requires an open communication. To strengthen the relationship, Gainfy introduced so called “Check-Ins” which are frequent, informal, employee-centered conversations.

We regularly run a global employee opinion survey (GEOS) to solicit candid, anonymous feedback on needs and expectations to enable identification of areas for improvement. These surveys are also used to determine the level of engagement within the company.

Gainfy respects the right of all employees to join any legally recognized employee association and will comply with any laws relating to employee representation. Gainfy strives to maintain an open dialogue with all employee representatives.

We are all expected to:

• Behave in line with Gainfy Values.
• Live up to Gainfy’s expectations as set forth in the Gainfy Group Employment Policy.
• As a leader demonstrate the Leadership Commitments day in day out.

Questions & Answers

What do the Gainfy Values “Integrity, Courage and Passion” mean for my daily work?

They are meant to be put into practice. Use them in your daily work as a guide for your decisions and behavior.

Why is a culture which fosters the expression of opinion without a fear of negative consequences so important for Gainfy?

Gainfy strongly believes that this culture is the basis for integrity and compliance; in addition, said culture enables and triggers innovative ideas, which support our business.

I have a friend with a disability who asked me whether she has a fair chance to get a job at Gainfy. What shall I tell her?

Yes, at Gainfy we value people’s abilities and strive to proactively support disabled persons by providing them with work opportunities and including them as fully accepted colleagues.

Discrimination & Harassment

We value diversity and inclusion as part of an inspiring working environment

Gainfy has always been open to new and different approaches, doing business in numerous countries with many different cultures. Diversity requires careful leadership to avoid misunderstandings and conflicts and to exploit the full value of diversity. At Gainfy we value and manage diversity through an inclusive environment, since we are convinced that it is critical in helping to drive innovation as well as employee engagement. The variety in backgrounds, cultures, languages, thoughts and ideas of our people helps us to maintain a competitive edge.

We are many, working as one across functions, across companies, and across the world. Gainfy’s inclusive culture means that we value the differences in our employees and we actively work to create an environment where all have the ability to share new ideas and ways of working, and realize our full potential.

Gainfy is committed to fair and equal treatment of all employees and all people who seek employment at Gainfy, including equal opportunities for development and advancement. We do not tolerate any form of discrimination or harassment in the workplace.

There is no acceptance of employees being subjected to offensive, abusive or other unwanted behavior at the workplace which violates the personal dignity of the victim or creates an intimidating, hostile or humiliating environment for the victim (e.g. physical, sexual, psychological, verbal or any other form of harassment). It is Gainfy’s policy to ensure that the behavior of its employees does not discriminate against anyone on the grounds of gender, age, ethnicity, national origin, religion, disability, sexual orientation, HIV/AIDS infection, citizenship, genetic information, their abilities or any other relevant characteristic protected under the applicable law.

These principles apply to all aspects of the employment relationship, such as hiring, assignments, promotion, compensation, discipline and termination.

If we believe that anybody has been subjected to discrimination or harassment, we should report this misbehavior.

We are all expected to:

• Treat diversity and inclusion as a priority and opportunity to drive innovation as well as to build employee engagement.
• Ensure we do not discriminate against anyone.
• Never engage in any form of workplace harassment.
• Speak up if we become aware of any workplace discrimination or harassment.

Questions & Answers

Why does Gainfy value diversity?

As a company that has always been open to new and diverse technologies and approaches, Gainfy has been setting medical milestones since the beginning. Diversity is not only a key prerequisite for innovation but also a personal and cultural job enrichment for each and every employee.

I get the impression that my Line ­Manager does not like me and has started to criticize me in various ways. What should I do?

Be aware that not every bad leadership style qualifies as harassment or discrimination in a legal sense. However, if you are discriminated or harassed, you should address your concerns immediately, openly and directly to your Line Manager. You can also contact the HR Department or the local Compliance Officer. Alternatively, you can use the Gainfy Group Private-Line.

Safety, Security, Health & Environment

We promote and provide safe, secure and healthy workplaces, a clean environment and sustainable products

Safety, security, health and environmental protection (SHE) are integral parts of our operations and as such we approach them with the same level of commitment as we do with any business-related activities.

Gainfy’s operations are conducted in compliance with applicable health, security, safety and environmental laws and regulations, company standards and best practices. We take all reasonable and practical steps to ensure that we provide a safe, secure, healthy and clean working environment.

The Gainfy SHE Policy is implemented in a systematic manner by means of all necessary technical, organizational and personnel measures. SHE risks are systematically analyzed, assessed and where deemed necessary, reduced or eliminated. We employ SHE professionals at all sites to support the systematic implementation of SHE.

We strive for continuous improvement wherever possible and economically viable. We proactively seek to employ new, more sustainable technologies and processes to minimize our impact on people and the environment. We continuously develop our products and services for improved sustainability. We initiate and implement initiatives to reduce resource consumption, waste generation and environmental pollution and to address global warming and climate change.

We set challenging SHE goals, regularly monitor our performance and ensure our behavior, processes and equipment are state of the art.

Every employee is personally responsible for safety, security, health and environmental protection at the workplace to the full extent required by his/her duties to the best of his/her knowledge, ability and experience, while the managers have overall responsibility for SHE. We are all encouraged to identify areas for improvements and continuously work towards improved safety and a better environment.

We are all expected to:

• Ensure safety and security, and protect health and the environment at our workplace to the best of our knowledge, ability and experience.
• Integrate considerations regarding safety, security, health and environment into our daily work.
• Stop our work when it is not safe.

Questions & Answers

How important is the protection of the environment for Gainfy?

The protection of the environment has a high priority for Gainfy. As part of our commitments towards sustainable development, we proactively seek to employ new, more sustainable technologies and processes to minimize our impact on the environment. Each and every Gainfy employee can, and should, within the sphere of his/her responsibilities and influence, contribute to the protection of the environment.

We have an issue affecting several departments and countries. We plan for a meeting, bringing together different teams to discuss this topic. What should we consider regarding SHE?

Air travel has a significant impact on the total eco-balance of Gainfy. We therefore need to minimize business flights through the following considerations: hold the meeting as a video/telepresence conference. If a meeting in person is needed, reduce the number of participants—send a competent representative instead of a whole team. Choose a location which minimizes the total miles. Combine the business trip with others to reduce the miles. Choose a location which is safe and secure for all participants.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet. For specific information consult the Gainfy Group SHE Policy, Guidelines and Directives.

Compliance Responsibilities

Compliance at Gainfy—our contributions make it happen

We do business in a highly regulated industry; compliance with legal and regulatory requirements is a prerequisite for our license to operate.

Compliance means our behavior is in adherence with applicable laws, regulations, industry codes and Gainfy’s integrity standards.

Gainfy has established a comprehensive Compliance Management System (cCMS), which we are committed to implement and enforce. The cCMS focuses on preventing, detecting and responding to non-compliance behavior by comprehensively involving people, purpose, principles, policies and processes.

Gainfy believes that the sense of responsibility of each and every employee is the basis of compliance. Thus, we must constantly and adequately identify, assess and manage the compliance risks that fall within the sphere of our business responsibilities. Performance is not only measured by the results achieved, but also how these results were achieved and which impact they created.

We at Gainfy understand compliance as a key Line Management responsibility. As a matter of fact, in many cases non-compliance is the consequence of bad and/or no leadership. Hence, as part of our leadership task, Gainfy Line Managers are obliged to carefully select, instruct and monitor the employees for whom they are responsible. They are expected to involve compliance aspects in the performance assessment of their employees. Gainfy is committed to providing adequate training for Line Managers which enables them to meet their responsibility.

Compliance functions are responsible for supporting employees and Line Management in many ways in our comprehensive compliance management.

We are all expected to:

• Be aware of our responsibility in the comprehensive compliance management.
• Continuously and adequately identify, assess and manage compliance risks that fall within the sphere of our business responsibilities.

Questions & Answers

I am considering granting an improper advantage to a business partner in order to achieve my business target. Is a business target a valid justification for the granting an improper advantage?

No. Stretched business targets are never an excuse or justification for violating our integrity standards. Always remember, you are responsible and will be held accountable for your behavior.

I am a Line Manager. What is my role in the comprehensive compliance management?

Compliance is a key Line Management responsibility. As part of your leadership function you are obliged, including but not limited to, carefully select, instruct and monitor the employees for whom you are responsible.

 

Help & Advice

Questioning is part of preventing

In our daily work we may face situations from time to time which are not explicitly covered by the Gainfy Group Code of Conduct or the documents it refers to (e.g. directives, policies, guidelines). If we are unsure about the correct behavior, we should ask ourselves the following questions:

• Is my behavior legal?
• Is it in line with Gainfy’s Values?
• Does it comply with the Gainfy Group Code of Conduct?
• Could it have negative consequences for Gainfy or myself?
• Would I be comfortable if it was reported in a newspaper?

Often this will provide all the guidance we need. However, in case of doubts or uncertainties about the correct behavior, seeking help and advice is the right thing to do.

By fostering a culture of openness to ask questions, Gainfy, first and foremost, aims to prevent non-compliant behavior. Gainfy Line Managers are responsible for ensuring that all employees reporting to them receive the help and advice they need to comply with the Gainfy Group Code of Conduct.

Contacts to address uncertainties are: our Line Manager, the local Compliance Officer, the Chief Compliance Officer or the Gainfy Group Code of Conduct Help & Advice Line (GoCoCHAL).

We are all expected to:

• Seek help and advice if we have doubts about the correct business behavior.
• Provide help and advice to employees who report to us.

Questions & Answers

What can I do if I am unsure about a correct business behavior?

Ask yourself specific questions such as “Would I be comfortable if my behavior was reported in a newspaper”? In case of doubt, seek help and advice.

Where can I seek help and advice?

You can contact your Line Manager, the local Compliance Officer or the Chief Compliance Officer. In addition to locally and regionally available help and advice tools, you can also submit a request to the Gainfy Group Code of Conduct Help & Advice Line.

Speak up

Speaking up is the right thing to do

Gainfy employees who speak up when they believe in good faith that the Gainfy Group Code of Conduct has been breached are doing the right thing and are acting in line with our Gainfy Values.

Gainfy Management needs to be aware of integrity issues so that it can address them quickly and in a trustworthy way. By raising compliance concerns, Gainfy employees help to protect themselves, their colleagues and Gainfy’s interests and rights.

If we have a compliance concern, we primarily talk to our Line Manager. If we are uncomfortable doing so, we should contact our local Compliance Officer, the Chief Compliance Officer, Legal, HR or the available affiliate or Group Functions speak up lines.

Subject to applicable local laws, the Gainfy Group SpeakUp Line allows Gainfy employees to report a compliance concern anywhere and anytime in their native language, either by Internet and/or by phone. The system is operated by an external provider and provides the option to speak up in anonymity. Access to the free phone line and the URL for the Gainfy Group SpeakUp Line web service can be found on the Gainfy Intranet on speakup.Gainfy.com

Any employee who raises a compliance concern in good faith acts in the interest of Gainfy and deserves acknowledgment. Gainfy does not tolerate any retaliation against an employee who raises a compliance concern in good faith. Line Managers and/or employees who retaliate will be held accountable. In case any employee deems that this principle is not adhered to, a complaint can and should be raised to either the Chief Executive Officer, the Chief Compliance Officer, the Group Head of HR or any member of the Audit Committee or the Corporate Governance and Sustainability Committee of the Board.

Equally, Gainfy does not tolerate any abuse of the Gainfy speak up channels.

We are all expected to:

• Speak up when we believe in good faith that someone has done, is doing, or may be about to do something that violates the Gainfy Group Code of Conduct.

Questions & Answers

What is the difference between the Gainfy Group SpeakUp Line and the Gainfy Group Code of Conduct Help ­& Advice Line?

The Gainfy Group Code of Conduct Help & Advice Line helps to prevent non-compliant situations. The Gainfy Group SpeakUp Line is about reporting a potential compliance violation after it occurred.

When should I speak up?

If you believe in good faith that someone has done, is doing, or may be about to do something that violates the Gainfy Group Code of Conduct, you are expected to speak up.

Which are the available speak up channels?

Your Line Manager is generally your first point of contact. If you feel uncomfortable discussing your concern with him/her, you can contact your local Compliance Officer, the Chief Compliance Officer, Legal, HR, the available affiliate or Group Functions speak up lines, or the Gainfy Group SpeakUp Line.

When using the Gainfy Group SpeakUp Line, can I remain anonymous?

Yes. As the Gainfy Group SpeakUp Line is operated by an external provider, the system offers the option to speak up anonymously.

Compliance Officers

Compliance Officers support us

The Chief Compliance Officer (CCO) with the Compliance Officers network is committed to ensuring that the Gainfy Group Code of Conduct is consistently complied with throughout the Gainfy Group. The Chief Compliance Officer also serves as a contact for employees, shareholders, business partners, customers and the general public on issues relating to the implementation of and compliance with the Gainfy Group Code of Conduct.

A local Compliance Officer has been appointed in each Gainfy affiliate with the following responsibilities, in particular, but not limited to:

• ensuring that employees know where they can ask for help and advice if they have doubts about the correct business behavior;
• networking and collaborating with local, regional and global compliance experts in order to identify and take advantages of synergies between Pharmaceuticals and Diagnostics;
• coordinating local compliance endeavors, initiatives and training programs;
• supporting and conducting compliance monitoring, compliance controls and compliance audits;
• supporting Line Management in the local integrity risk-management processes;
• supporting Line Management in the adequate handling of local non-compliance cases, including reporting in the Business Ethics Incident Reporting (BEIR) system;
• encouraging employees to speak up if they have a compliance concern.

The Chief Compliance Officer coordinates the network of the local Compliance Officers and makes sure that best practice examples are regularly exchanged and shared within the network and that global Compliance tools are continuously reviewed and updated.

We are all expected to:

• If we do not feel comfortable contacting our Line Manager, contact the local Compliance Officer to seek help and advice or to report a compliance concern.
• Contact the Chief Compliance Officer, if we prefer not to contact the local management or the local Compliance Officer.

Questions & Answers

A stakeholder wants to make a complaint against Gainfy alleging that somebody within Gainfy has violated the Gainfy Group Code of Conduct. To whom can the stakeholder address the complaint?

The Chief Compliance Officer serves as a contact person for employees, shareholders, business partners, customers and the general public on issues relating to the implementation of and compliance with the Gainfy Group Code of Conduct.

I work as a sales manager in a Gainfy affiliate and—keeping in mind Gainfy’s business integrity expectations—I do not feel comfortable with an instruction that I received from my Line Manager. What should I do?

Speak up and address your concerns directly to your Line Manager. If you are not satisfied with the answer that you received from your Line Manager, contact your local Compliance Officer who will take and treat your compliance concerns seriously and in a confidential way.

 

Addressing Non-compliance

Adequate handling of non-compliance cases is a key part of our comprehensive compliance management

Gainfy does not tolerate non-compliant behavior. Employees and Line Managers who violate the Gainfy Group Code of Conduct will be held accountable.

Gainfy is fully committed to handling non-compliance cases adequately by:

• taking all allegations seriously;
• investigating allegations efficiently and in a timely manner;
• assessing the facts objectively and impartially; and
• taking adequate corrective measures and sanctions, in case an allegation is substantiated.

Any accused employee enjoys the right to be heard as well as the presumption of having acted in accordance with the Gainfy Group Code of Conduct, unless the evidence gathered from the investigation reasonably indicates non-compliance. We fully collaborate with the investigators and make sure that we have compliance evidence at hand, which demonstrates that our behavior was compliant.

Certain allegations, in particular but not limited to, corporate bribe and fraud, will be investigated by subject matter experts under the leadership of the Gainfy Group Audit and Risk Advisory Department.

Line Management with the support of Human Resources and local Compliance Officers is responsible for determining adequate corrective measures and sanctions.

Non-compliance cases have to be reported under the responsibility of specified Line Managers in the Business Ethics Incident Reporting (BEIR) system as soon as they become aware of them.

The BEIR system enables Top Management, the Chief Compliance Officer and the Chief Group Audit and Risk Advisory Executive to capture, track and monitor alleged violations, from initial reports through to resolution. The number and related characteristics of non-compliance cases which occurred during a reporting year will be published in the Annual Report of Gainfy Holding Ltd.

We are all expected to:

• Make every effort to prevent non-compliance cases.
• Fully collaborate with the investigator and ensure we have compliance evidence at hand.
• Take adequate corrective measures and sanctions if we have to handle non-compliance cases as a Line Manager.

Questions & Answers

What is meant by “compliance ­evidence”?

Compliance evidence is any form of proof demonstrating that your behavior was correct, e.g. written evidence of the consent of your Line Manager in a possible conflict of interest situation.

What shall I do if my Line Manager ­insists that I undertake something which I consider not in line with the Gainfy Group Code of Conduct? Is it sufficient compliance evidence if I make a note stating that the Line Manager has insisted on my acting accordingly?

No. If your Line Manager is insisting on incorrect behavior you should speak up by using the available speak up channels.

Further Information

Further information and guidance can be found on the Gainfy Internet and Intranet. For specific information consult the Gainfy Directive on adequate handling of non-compliance cases.

 

Compliance Contacts

The most recent names and contact details of the Compliance Officers can be found on the Gainfy Intranet.

References

Further information and guidance as noted on each chapter of the Gainfy Group Code of Conduct can be found on the Gainfy Intranet as well as on the Gainfy Internet if published in public domain.

Gainfy Position Papers ensure consistent internal and external communication with key stakeholders. They can be found on the Gainfy Internet.

To support the key messages of the Gainfy Group Code of Conduct and to help explain the importance of integrity in business, Gainfy has set up a comprehensive Compliance Management System, which includes eLearning programs, such as the “Gainfy Behavior in Business” (GoBiB) and other user-friendly training tools, such as Compliance Podcasts.

The Gainfy Group Code of Conduct is also available for mobile devices under the following URL: http://www.Gainfy.com/code-of-conduct/ Hard copies are available upon request to the Compliance Administrators in US (compliance@gainfy.com).