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Kyowa Kirin, Inc. is committed to improving the lives of patients and their families. This common goal unites us and compels us to set high standards for ourselves, including always acting with the utmost honesty and integrity. There is never a situation when compromising our standards is either expected or acceptable. Our focus on the patient and our high standards should be evident in our values, words, and actions. By setting these high standards for ourselves and our partners, vendors, and agents, our commitment to upholding Kyowa Kirin's values is clear.

Kyowa Kirin Corporation is dedicated to complying with all applicable laws, regulations, guidance, and industry standards. Kyowa Kirin has developed a Comprehensive Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the U.S. Department of Health and Human Services Office of Inspector General (OIG Guidance) and which includes policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code).

The Kyowa Kirin Compliance Program includes numerous policies and procedures including our Code of Conduct, Team Guide: Compliance Policies and Procedures, and the Kyowa Kirin International Integrity Line. The Compliance Program is consistently assessed and evaluated to ensure alignment with additional or updated laws and guidance. It is designed to prevent, detect and remediate violations of law, regulations and company policies, as well as to promote an ethical culture that will, guide our interactions with healthcare professionals and healthcare entities. If Kyowa Kirin becomes aware of any possible or actual violations of policy or law, an investigation will be initiated and, if necessary, followed by appropriate corrective actions in accordance with the Kyowa Kirin Compliance Program.

California Declaration of Compliance

Statement regarding compliance with California Health & Safety Code § 119402

Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Kyowa Kirin hereby declares that, to the best of its knowledge, its Comprehensive Compliance Program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and PhMRA Code and limits on gifts and incentives to health professionals. Subject to the above, Kyowa Kirin also hereby declares that it is in compliance with its Comprehensive Compliance Program as of January 1, 2020.

As part of the Compliance Program, Kyowa Kirin has established a specific annual aggregate dollar limit of $1,500 on gifts, items or activities Kyowa Kirin may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis. This limit may be revised occasionally by Kyowa Kirin at its sole discretion, in which case the revised limit will be published in this section of the Kyowa Kirin website within a reasonable period following revision. This limit represents an expenditure cap and not a goal or an average expenditure amount.

Historically, expenditures for such items have been substantially less than this limit for most healthcare professionals with whom Kyowa Kirin interacts. The annual limit does not include the following expenditures:

  • Drug samples given to physicians and healthcare professionals;
  • Financial support for continuing medical education programs;
  • Financial support for health educational scholarships;
  • Payments for legitimate fair market value professional services, including but not limited to consulting fees, advisory board fees, and speaker fees, and any meals or expenses associated with the provision of such services; and
  • Educational materials provided to physicians with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition.

Copies of the Declaration of Compliance may be obtained upon request by contacting Kyowa Kirin, Inc..