Our Impact

The US Code of Ethics and Professional Conduct (the “Code”) describes Otsuka’s fundamental values and summarizes the policies and legal requirements that apply to our business. The Code is supported by policies and procedures governing our general business activities as well as those activities related to marketing and sales of our pharmaceutical products and interactions with healthcare professionals.

Otsuka provides Compliance and Ethics learning programs for all employees and relevant third-party suppliers. General compliance training includes understanding our Compliance Program, the Code, policies and standard operating procedures. Otsuka provides training specific to federal healthcare program and Food & Drug Administration (“FDA”) requirements related to promotional and product-related functions, training to prevent fraud and corruption, as well as training regarding Good Manufacturing and Good Clinical Practices. The Ethics & Compliance Group also works with its business partners throughout the Company to provide continuing advice on compliance and quality matters. Finally, we ensure that our education and training programs are effective by applying adult learning principles.

Otsuka has a Speak-Up policy, which requires all employees to speak up when they have a question regarding a Company policy or procedure, or when they are faced with an ethical dilemma. All employees should feel comfortable requesting guidance from the Company, and are encouraged to discuss any questions, concerns, complaints or suggestions with their supervisor, Human Resources, Ethics & Compliance (“E&C”), or Legal Affairs.

Our Code requires employees to report any known or suspected violations of company policies to their supervisor or to the Chief Compliance Officer (“CCO”). Additionally, Otsuka’s policies strictly prohibit any adverse action against any person who, in good faith, reports known or suspected compliance issues. The Company has an established toll-free telephone number, 1-800-363-5670, for reporting violations or possible violations of the Compliance Program or other company policies. In the event the Company becomes aware of any suspected noncompliance with the Compliance Program or the relevant policies and procedures, through either routine monitoring or a reported violation, the Chief Compliance Officer will investigate the circumstances surrounding the suspected noncompliance to determine whether a violation has occurred. If the investigation reveals a violation, the Company will take appropriate corrective action, which may involve disciplinary actions up to and including termination.

All Otsuka colleagues are constantly evaluated on their adherence to the principles expressed in our Code. The potential disciplinary actions that can be taken when employees are found to have violated Company policies, or have failed to report violations, of which they were aware, are explained in the Code. Our Code also highlights the heightened responsibilities of supervisors with regard to compliance.

The CCO is charged with monitoring the Compliance Program, and serves as the primary contact for issues relating to compliance with the Program. The CCO reports directly to the Chief Executive Officer (“CEO”), and provides periodic reports to the Board of Directors and the Audit Committee of the Board of Directors. The CCO also serves as the Chair of the Compliance Committee, which is composed of senior management personnel and provides oversight and guidance for compliance activities.

Otsuka’s Compliance Program is continuously evolving, incorporating learning from internal auditing and monitoring, as well as external trends and developments. Each year, a compliance auditing and monitoring plan is developed to test the implementation and effectiveness of compliance policies and procedures, utilizing both risk-based and random sampling techniques. Results of each audit and activity monitoring are shared with the appropriate Business Owners and the Compliance Committee to assess any needed follow-up actions.

Otsuka’s Compliance Program utilizes a risk-based approach to focus resources. We routinely assess the risks inherent with new programs and concepts, and we consider the level of risk when designing audit and monitoring plans. Additionally, Otsuka regularly seeks a third-party view of its operations, commissioning risk assessments from external parties.

All third parties with whom Otsuka does business are subject to screening to ensure that they do not present additional risk to the Company’s business or reputation. Otsuka’s contracts with third parties include compliance training requirements and assurances, audit rights, and other provisions depending on the type of service provided by the third party.

Otsuka conducts due diligence on all potential acquisition targets, as well as on all companies with whom it enters into joint promotion and development agreements. This due diligence includes, but is not limited to, an assessment of the compliance program, policies and procedures, and internal controls. After acquisition, Otsuka will ensure a thorough integration, ensuring that new colleagues understand its commitment to compliance and our Compliance Program, and that internal controls extend to the acquisition target.