Compliance

Shionogi Inc. (“Shionogi”), a Delaware corporation, is committed to conducting its business in an ethical, compliant and responsible manner. This commitment is evident in the culture of the company, which is established by Shionogi’s Board of Directors, Executive Team and the Compliance Office, and manifests itself in how each employee works and in our interactions with customers, healthcare providers, patients and the public. As part of its commitment to ethical business practices and compliance, Shionogi has developed and maintains a Comprehensive Compliance Program (“CCP”) designed to promote compliance with federal and state statutes, regulations, codes and industry guidelines. The CCP is dynamic and specifically tailored to meet the unique structure and requirements of Shionogi.

As set forth in Shionogi’s Code of Conduct, all Shionogi employees must comply with all Company policies, procedures, applicable laws, codes and regulations, including those related to the development, marketing, sale and distribution of drug products. Shionogi employees must strictly adhere to federal and state fraud and abuse laws, including the Anti-Kickback Statute and False Claims Acts.

 

Additionally, Shionogi’s CCP incorporates and adheres to industry standards, codes, guidance and best practices in the area of compliance, including the Compliance Program Guidance for Pharmaceutical Manufacturers, developed by the United States Department of Health and Human Services’ Office of Inspector General (“OIG Guidance”) and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Revised Code on Interactions with Health Care Professionals (the “PhRMA Code”).

Shionogi has established written policies and procedures, including but not limited to its Code of Conduct, Compliance Field Manual and a comprehensive set of other compliance-related policies and procedures. The Company’s written policies and procedures are designed to instruct and guide our employees, agents and consultants to comply with laws and regulations, as well as to set forth the Company’s ethical standards. For example, the Compliance Field Manual is particularly designed to guide the field sales force on how to ethically, legally and responsibly interact with our customers on a variety of sales and marketing activities.

Shionogi has appointed a Compliance Officer who is charged with the oversight, monitoring and implementation of its CCP. The Compliance Officer reports to the president and the management team as needed. The Compliance Officer also periodically reviews and revises the compliance program to respond to changes in the company’s needs, applicable laws and regulations, and best practices in the industry. Additionally, Shionogi has established a Compliance Oversight Committee to provide leadership and assist in the development and implementation of the CCP. The Compliance Oversight Committee is chaired by the Compliance Officer, and its membership consists of senior management.

Shionogi provides regular education and training for all employees (e.g., officers, directors, managers, etc.) regarding the CCP. Shionogi also provides more specific education and training to employees who interact with healthcare practitioners, employees who are involved in the sale and marketing of pharmaceutical products and employees who are in a position to prevent and reduce the risk of fraud and abuse in federal and state healthcare programs. This additional education and training includes, but is not limited to, training on Company policies and procedures which are consistent with the PhRMA Code, the OIG Guidance, Anti-Kickback Statute, laws and regulations governing the advertising and promotion of pharmaceutical products, and the Prescription Drug Marketing Act, among others. The Company will review and update its training programs periodically, as well as identify additional areas of training on an ongoing basis.

Shionogi has established and implemented avenues, including but not limited to the Alert Line, for reporting general issues and allegations of suspected misconduct and/or to raise compliance concerns. In addition, Shionogi has an open door, anti-retaliation policy to encourage and protect employees who raise issues, concerns, problems and suggestions with their immediate supervisor or other manager without fear of retaliation and with the assurance that the matter will be protected from improper dissemination or disclosure.

Shionogi uses audits and other evaluation techniques to monitor compliance, identify problem areas and assist in the reduction of identified problems. The goal of these audits is to ensure (i) that Shionogi has adequate policies in place covering identified risk areas, (ii) that the policies have been effectively implemented and communicated and (iii) that the policies are being followed. Such auditing and monitoring take place under the direction of the Compliance Office.

When compliance violations by Company employees, consultants or agents have been confirmed, appropriate disciplinary action is taken. The specific disciplinary action for misconduct varies depending upon the situation, but ranges from verbal warnings to termination. Each situation is evaluated by the employee’s supervisor, the Human Resources Department and/or the company’s Compliance Office, taking into account all relevant factors.

Shionogi is committed to hiring a workforce that maintains a high degree of integrity, accountability, teamwork, business results and work-life balance in order to achieve professional as well as overall Company goals. Shionogi requires that all employees are qualified and skilled for the position attained. All prospective and/or current Company employees undergo a drug screening and background check to ensure that the individual has not been convicted of a criminal offense that falls within the scope of 42 U.S.C. §1320a-7(a). Company employees, agents and consultants are also screened to ensure that they are not excluded, debarred, suspended or otherwise ineligible to participate in any federal or state healthcare program, or procurement or nonprocurement program.

In addition to the requirements set out in the PhRMA Code, Shionogi has established an aggregate annual spending limit of $1,500 on meals and educational items which may be provided to a healthcare professional. Fees for services to healthcare professionals are not included in this amount, but such fees are based on fair market value for the services. Prescription product samples intended for free distribution to patients, as well as financial support for continuing education programs and health education scholarships, are exempt from this limit.