Genmab has adopted a new Code of Conduct to promote ethical and compliant conduct in all aspects of our business. The updated Code is applicable to Genmab’s Board of Directors, Executive Management, employees and contingent workers globally. Aptly titled Code of Conduct-Living Our Values, the new Code seeks to engage and inspire our people to consider how their everyday activities should be conducted in a manner reflecting our core values of innovation, determination, integrity, and teamwork. The Code reflects the standards of conduct we expect from our own people as well as our partners, vendors, suppliers and other third parties with whom we engage. All employees are required to complete annual training on the Code and attest to their compliance.

Read our Code of Conduct.

Genmab develops, manufactures, and delivers investigational antibody therapeutic products for clinical testing that provide significant benefit to patients and to our customers. A company-wide quality policy has been defined and implemented to ensure that these products meet current regulations promulgated by the Danish Medicines Agency, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), International Council for Harmonization (ICH) Quality guidelines, Health Insurance Portability and Accountability Act (HIPAA) as well as customers’ expectations.

Genmab has a strong culture of quality with dedicated senior management leadership and commitment of employees at all levels to achieve and maintain a quality minded approach to everything we do.

Management Responsibility

Senior management is responsible for securing a company-wide commitment to quality and for the performance of the Pharmaceutical Quality System (PQS). Senior management defines the quality objectives and commissions the appropriate qualified employees and resources to achieve these objectives.

Senior management has established the PQS and organized a Quality Assurance (QA) unit to maintain and develop the PQS. This is to secure compliance to current regional and global regulatory requirements to meet industry standards and Genmab’s quality objectives. Quality Performance Indicators (QPIs) are defined and monitored. Senior management will periodically review the quality of Genmab products and the performance of the quality system during Quality Management Review (QMR) and advocates a continuous improvement of quality.

Senior management has ensured that processes are in place for a timely and effective communication and escalation of critical quality issues to the appropriate level of management.

Quality Management

Genmab has established a PQS that includes quality policies and procedures that employees must follow. The PQS is process-oriented and encompasses all relevant product lifecycle phases and GxP activities including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Vigilance Practice (GVP) and Good Distribution Practice (GDP). The PQS covers the company’s activities in pre-clinical development, clinical development and manufacturing and supply of products for clinical studies and eventually for commercial use. The research area within Genmab has established an independent quality system to secure quality performance in the non-GxP area.

The Quality Manual is the top-level quality document, and it is implemented to define and communicate the quality policy and how the PQS is organized. The Quality Manual applies to all Genmab employees and is approved by the Chief Executive Officer, Chief Financial Officer and Chief Development Officer.

Operational Quality

Genmab has established a training program to ensure all employees in GxP areas are properly trained and qualified to perform their work. This is facilitated using defined job descriptions, C.V., training plans, and training documentation to demonstrate compliance and qualification. Genmab has a knowledge-sharing culture. Competencies needed for job functions are continuously reviewed and deficiencies are mitigated by hiring, contracting, training and/or educating employees.

Quality risk management is applied throughout all operational activities to consider risk to patient safety, patient rights, regulatory compliance, product quality and data reliability and integrity when making decisions related to the lifecycle of a product including product development, manufacture, distribution and all stages of clinical trials. Risk assessment is used to assess hazards and defects to reduce redundant and non-value-added efforts and keep the focus on efforts that have optimal impact on patient safety, product quality and data reliability and integrity.

A system for quality deviations and Corrective and Preventive Actions (CAPA) is in place ensuring that deviating products or processes are well identified, described and handled, that root causes are well understood, that actions are taking to avoid recurrence and that measures are taken to ensure that the quality, safety and efficiency of the products remain intact.

Recall and complaint procedures are in place for patient safety to ensure that non- conforming products are not used by patients. Recall procedure is frequently tested.

External Partners

Genmab utilizes an outsourcing business model for the production, testing and distribution of products and for conducting clinical trials. Through the vendor assessment and onboarding process as well as operational and quality oversight, Genmab ensures that the Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and other service providers meet both Genmab and applicable regulatory requirements and operate with adequate standards of quality and service as per industry standards and best practices, e.g. HACCP, ISO, ICH, etc.

Quality Oversight

A quality audit program has been established for all GxP areas where internal as well as external partners are audited at predefined intervals. Genmab is furthermore subject to inspections from authorities and audits from partners.

Genmab is committed to building a sustainable and socially responsible biotech, one whose actions reliably benefits patients, stakeholders, and society as a whole. We are dedicated to further building a sustainable organization that meets those environmental, social and governance (ESG) criteria most relevant to our business, thereby creating long-term value for all of our stakeholders. At Genmab, we define Corporate Social Responsibility as the way in which we incorporate our purpose, values and vision with our business operations, interactions with stakeholders and our commitment to ESG issues. This Policy applies to activities undertaken by or on behalf of Genmab. Employees will adopt the CSR considerations described in this Policy into their day-to-day work activities.

Read our CSR Policy.

Policy regarding the Diversity and Proportion of Gender in other Management Levels of the Genmab group:

This policy has been adopted by the Board of Directors of Genmab A/S (“Genmab”) in accordance with Section 139a of the Danish Companies Act and the Danish Recommendations on Corporate Governance.

Genmab recognizes the importance of promoting diversity and is committed to continue working towards and maintaining diversity and equal opportunities for employees at all management levels in the Genmab group, regardless of gender, age, race, religion or ethnicity. Genmab encourages talented employees to pursue a career in the company. Genmab regularly conducts employee surveys and employee development interviews to identify barriers – or the perception of barriers – preventing equal opportunities for employees. In connection with recruitment, including recruitment at management level, it is the policy of the Genmab group to meet the company’s needs for employees with the right skills and competences, regardless of gender, age, race, religion or ethnicity. When choosing between equally qualified candidates, the diversity among the employees shall be taken into consideration, as it is the aim that both genders attain a representation at management levels of at least 40%. In connection with recruitment for managerial positions it must be ensured that the employment procedures are designed to give men and women equal opportunities to apply for and obtain managerial positions and, where possible, that the candidates invited for interview include both men and women. The company’s focus on diversity among its employees, including at management levels, must be visible during recruitment.

The policy may be amended by the Board of Directors and should be interpreted in accordance with applicable equal rights and anti-discrimination legislation in Denmark, in force from time to time.

A Target Figure for the Number of Women in the Board of Directors of Genmab A/S has been established.

Click here for more information.

As a global biotechnology company committed to social responsibility and sustainability, Genmab strives to comply with all laws, regulations, and standards applicable to the conduct of its business. While governments have a duty to protect the human rights of their citizens, we recognize that businesses also have a critical role to play. Genmab is dedicated to conducting business in a way that respects the dignity of all people.

Read our Human Rights Commitment.

Enabling employees and external stakeholders to speak up when they observe potential misconduct or have concerns about matters relating to our business is vital to retaining our strong Genmab culture and to doing the right thing. The Genmab Speak Up Policy allows for confidential and (where allowed) anonymous reports that will be directed to Genmab Compliance for initial triage and handling. This approach renders the reporting process more accessible and easier to navigate.

Importantly, our new policy also extends protections not only to our regular employees, but also contingent staff, part-timers, temp staff, trainees, interns (both current and former) and others who choose to report their concerns.

Speak Up Compliance Hotline

• 24/7 – Online or by Phone

• GenmabSpeakUp.ethicspoint.com

• Denmark: 80-83-01-69

• Netherlands: 0800-020-1556

• United States: 1-844-942-3289

• Japan: 0800-123-0136

Read our Global Speak Up Policy.

The Board of Directors and Genmab’s Executive Management are committed to an integrated Corporate Social Responsibility (CSR) strategy, focusing on employee well-being, ethics and compliance in relation to our research, the environment and business ethics and transparency. Our tax policy is fully aligned with our business-driven CSR strategy: it reflects our commitment to business ethics and to building a sustainable organization, while the publication of our tax policy displays our focus on transparency.

Read our Tax Policy.