U.S. Compliance Program

MorphoSys Compliance Program

At MorphoSys we are driven by our mission: More life to people with cancer. This is a big responsibility, and as such, we must operate with the highest level of integrity, consistent with all applicable laws and regulations. With this in mind, the MorphoSys Compliance Program has been established to support MorphoSys personnel in our commitment to ethical and compliant behavior. MorphoSys employees, contractors, and agents are expected to know, understand, and support the organization’s Compliance Program.

The MorphoSys Compliance Program is anchored by our Company’s Credo and the Code of Conduct. In addition, key components of the MorphoSys Compliance Program have been designed on several key regulations and guidance, such as the Seven Elements of an Effective Compliance Management Program as communicated by the Office of Inspector General (OIG). Further, at MorphoSys, we recognize that an effective compliance program evolves to changing circumstances and therefore, we are committed to continuous improvement based on regular reviews, assessments, and developments.

The MorphoSys Compliance Program is comprised of multiple compliance streams that focus on anti-bribery, risk management, and transparency and disclosure efforts. In particular, the Program stands on the following pillars:

  • Responsibility and Oversight
  • Policies and Procedures
  • Education and Training
  • Internal Communication and Reporting
  • Auditing and Monitoring
  • Responding to Potential Violations
  • Corrective Action

For more information on the MorphoSys Compliance Program read below or contact:

MorphoSys AG
Semmelweisstr. 7
82152 Planegg, Germany
Tel. +49 (0)89 / 899 27-0
Attn: Global Compliance

MorphoSys, Inc.
470 Atlantic Avenue, Suite 1401
Boston, MA 02210
Tel. +1 (844) 667-1992
Attn: US Compliance

Responsibility and Oversight

The Management Board of MorphoSys bears the overall responsibility for the Compliance Program, and reports compliance matters to the Audit Committee of the Company’s Supervisory Board. The Management Board has set up a Compliance function that ensures the required resources for compliance-related tasks.

The Global Head of Compliance leads the Compliance function and chairs the Global Compliance Committee.

The Global Head of Compliance and the V.P., U.S. General Counsel and U.S. Head of Compliance and respective teams are responsible for the development and ongoing implementation of the MorphoSys Compliance Program with support and oversight from the Global and U.S. Compliance Committees.

The Global Compliance Committee is comprised of key member of MorphoSys’ Executive Committee. The U.S. Compliance Committee is comprised of senior management in key functional areas across the U.S. organization, including the U.S. General Manager. Each Committee meets at least quarterly to review and develop action plans to address compliance-related matters.

Policies and Procedures

The MorphoSys Code of Conduct sets forth the key principles and ethical standards for how we work together to develop and deliver innovative therapies, how we protect the value and integrity of MorphoSys worldwide, and how we work with our customers, suppliers, public authorities, and other partners and stakeholders in conducting our business. The Code of Conduct applies to all employees and Management Board members (including officers and directors) of MorphoSys. Certain business partners, such as agents, consultants and vendors serve as an extension of MorphoSys. They are expected to follow the spirit of the Code of Conduct, as well as any applicable regulations and contractual provisions, when working on behalf of MorphoSys. We expect all of us to act with honesty and integrity, to comply with applicable laws and industry practices, and to exercise reasonable judgment when conducting business on behalf of MorphoSys.

In addition to our Code of Conduct, MorphoSys has developed additional policies and procedures to address potential risk areas identified in the OIG Guidance and to also comply with the Code of Interactions with Healthcare Professionals issued by the Pharmaceutical Research and Manufacturers of America (the “PhRMA Code”).

Further, to comply with the California Health and Safety Code § 119402, the U.S. Policy on Business Courtesies for U.S. Healthcare Professionals has established a maximum annual aggregate U.S. dollar limit of Two Thousand Dollars ($2,000) for gifts (as defined by the Safety Code, such as meals), promotional materials, and related activities that may be provided to U.S. health care professionals. For the avoidance of doubt, MorphoSys does not provide gifts to healthcare professionals.

Education and Training

Every year MorphoSys requires personnel to complete training relevant to the Code of Conduct and the Compliance Program. MorphoSys strives to develop training solutions that will support colleagues’ execution of activities related to their responsibilities and to ensure compliance with MorphoSys written standards, policies, and procedures. Training is assigned based on roles and delivered in person and through the learning management system. We maintain and monitor training records to help ensure all personnel have received required training.

Internal Communication and Reporting

MorphoSys has established both a toll-free and web-based Integrity Line, which allows personnel to report concerns about any potential violation of law or compliance policies. The Integrity Line allows for the option to remain anonymous. As part of the Compliance Program, MorphoSys personnel are made aware of reporting mechanisms as part of new hire orientation, continuous compliance training and general awareness campaigns, as well as postings on the company’s intranet site. Personnel may also seek guidance or report suspicious or concerning conduct through a variety of other internal mechanisms. Moreover, all personnel are obligated to report all suspected violations of law or compliance policies under the Global Policy “Reporting Compliance Violations” and the U.S. policy on Reporting, Investigating and Responding to Potential Misconduct. MorphoSys’ Non-Retaliation policy protects employees who make good faith reports about issues and concerns.

Auditing and Monitoring

Consistent with the OIG Guidance, MorphoSys has established comprehensive Auditing and Monitoring plans. These plans reinforce MorphoSys’ commitment to integrity by reviewing and analyzing company promotional and non-promotional activities to identify potential signals of risk. Monitoring activities could be live or consist of document reviews. Personnel are expected to cooperate with all auditing and monitoring activities, with results reviewed and remediated as appropriate.

Responding to Potential Violations and Corrective Actions

MorphoSys follows our Compliance policies and procedures for addressing potential compliance-related concerns. MorphoSys responds to potential violations in a prompt and effective manner. Any enforcement or discipline taken because of a compliance-related concern ensures all relevant facts and circumstances are understood and considered. Further, remediation must be appropriate and undertaken in a consistent manner when addressing inappropriate conduct and deterring future violations. Remediation activities may range from process changes, re-training, or discipline, up to and including termination of employment or services.

Declaration of Compliance

As described on this site, MorphoSys has established a comprehensive Compliance Program. The Program has been designed in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector General of the US Department of Health and Human Services. To the best of our knowledge, as of July 2024, MorphoSys is in compliance both with its own Compliance Program and with California Health & Safety Code §119402.

Disclaimer: This portion of the MorphoSys website is intended for U.S. residents only. It is not for individuals living in Germany and other European Union member states.