Kastle is committed to essential principles of good corporate conduct, ethics and integrity in all activities. Establishing and maintaining an effective Compliance Program is a key component of this commitment.
The Kastle Compliance Program fosters a culture of ethics and compliance to prevent, detect and correct violations of law or company policy. Kastle expects that its employees, contractors and agents will comply with our Code of Business Conduct ("the Code"); and with the policies, procedures, guidelines, and training established in support of the Code. If Kastle becomes aware of violations of law or Kastle policy, we will investigate the matter and take appropriate disciplinary action and implement corrective measures to prevent future violations.
We have specifically designed and scaled our Compliance Program to fit the size, resources, market position, and other unique aspects of our company. At Kastle, we recognize that an effective compliance program must evolve and respond to the changing circumstances of the company and its environment. To this end, we are committed to continuous quality improvement based on regular review, assessment, and development of the Compliance Program and the changing regulatory and business environment.
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) Guidance for Pharmaceutical Manufacturers outlines eight key elements of an effective compliance program. We have developed and implemented our Compliance Program to address each of these elements.
1. Responsibility and oversight
Kastle has designated an Interim Chief Compliance Officer (“CCO”), who is responsible for developing, overseeing, and monitoring the operation of our Compliance Program. Our CCO has the authority to exercise appropriate professional judgment regarding the Compliance Program, and to develop and implement improvements as needed to maintain an effective Compliance Program. Our CCO reports to our president, and has independent reporting authority and responsibility to our Board of Directors on compliance-related matters.
Kastle has also established an Executive Compliance Committee to advise and collaborate with the Chief Compliance Officer. The Compliance Committee is comprised of the key senior executives from various functions in the company. The Compliance Committee is charged with oversight of Kastle’s Compliance Program and meets at least quarterly to review and develop plans to address compliance-related matters.
2. Policies and procedures
Kastle’s Code of Business Conduct is our statement of ethical and compliance principles that guide our daily operations. The Code establishes key ethical principles that we expect management, employees, contractors, and agents of the company to follow, as well as standards to help ensure compliance with applicable laws and company policies. To emphasize the importance of the principles and guidelines contained in the Code, we require each of our employees to certify that he or she has read and agrees to abide by all Kastle policies and procedures.
In addition to our Code, Kastle has developed and implemented policies, procedures, guidelines, and other instructions to address risk areas for pharmaceutical manufacturers including those identified in the OIG Guidance. Our policies and procedures also help ensure that Kastle adheres to the standards of the PhRMA Code.
For purposes of complying with the California Health and Safety Code § 119402, Kastle has established a maximum annual aggregate dollar limit of Two Thousand Dollars ($2,000) for gifts, promotional materials, and related activities provided to California health care professionals ("HCPs"). This is an annual limit, not a goal or average, and the amount spent per HCP is anticipated to be substantially less than this maximum amount. Waiver of the limit would require the approval of the CCO.
3. Education and training
Education and training are essential to effectively communicate our standards and requirements to our personnel, and enable them to perform in accordance with them. All personnel receive training on Kastle’s Code of Conduct and on the compliance-related policies, procedures, and guidelines applicable to their job functions.
We maintain and monitor training records to help ensure all personnel have received required training. Education and training are critical elements of our Compliance Program, specifically with regard to training personnel on their legal and ethical obligations under applicable state and federal health care program requirements.
4. Internal Communication and reporting
Kastle is committed to fostering an active and healthy dialogue between management and employees regarding ethical and compliance-related matters. Kastle personnel are encouraged to seek answers to compliance-related questions, and are provided with guidance on how to access compliance-related information, including how to report potential compliance violations. Kastle understands that its personnel must not just know how to access compliance-related resources, they must feel comfortable doing so without fear of retaliation.
Kastle has adopted policies and procedures that strongly encourage all personnel to report potential suspected compliance violations. These policies and procedures include measures intended to ensure that appropriate reports will not subject the person making the report to retaliation by Kastle or its personnel.
All of Kastle's compliance policies and procedures and the Code are available to all employees via Kastle's intranet site. Kastle has established a toll-free 24/7 Hotline/Helpline to report potential compliance violations or to seek proactive guidance. Information about Kastle’s Compliance Hotline/Helpline is given to all personnel as a part of new hire orientation and initial compliance training. It is also available on the intranet site.
5. Auditing and monitoring
Monitoring and auditing help evaluate on-going adherence to our compliance-related policies and procedures. Consistent with the OIG Guidance, we take a number of factors into consideration when determining the nature, extent and frequency of our compliance monitoring and auditing activities.
New legal requirements, developments in business practices, and similar considerations may result in new or revised compliance-related monitoring and auditing activities. We conduct field rides every other month and semi-annual compliance audits. We review our compliance-related monitoring and auditing activities on a regular basis to help ensure that significant risks are appropriately addressed.
6. Enforcement and discipline
Kastle maintains policies and procedures for addressing potential compliance-related violations. These help ensure that relevant facts and circumstances are understood and considered in connection with all enforcement and disciplinary activities. These policies and procedures are intended to help ensure that appropriate and consistent action is employed to address inappropriate conduct and deter future violations.
7. Corrective action procedures
Kastle helps ensure compliance with state and federal health care laws, as well as with our internal policies and procedures. We believe that our Compliance Program increases the likelihood of preventing or identifying unlawful and unethical behavior.
We recognize, however, that even an effective compliance program will not prevent all violations. Our Compliance Program, therefore, requires the company to respond promptly to potential violations of law or Kastle policy; take appropriate disciplinary action; assess whether the violation may be due to gaps in our policies, practices, or internal controls; and take appropriate corrective action to prevent or limit future violations.
8. Risk assessment
Kastle regularly conducts a risk assessment to ensure that its Compliance Program continues to address appropriate risks.
Kastle is committed to conducting all activities in compliance with applicable laws and ethical standards. We believe we have developed and implemented an effective Compliance Program, and we will continue to work to improve the program and related activities.
STATE OF CALIFORNIA COMPLIANCE PROGRAM DECLARATION
Last revised June 21, 2017
As part of our continued commitment to compliance, Kastle Therapeutics, LLC (“Kastle”) has developed and implemented a Compliance Program consistent with the HHS OIG Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Guidance”) and the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”). The Kastle Compliance Program meets the requirements of the California Marketing Practices Act (California Health and Safety Code §§ 119400-119402). Kastle’s Compliance Program is intended to help prevent, detect and correct compliance-related infractions and problems. Kastle recognizes that even an effective compliance program may not prevent all compliance violations, so we have, as part of the Compliance Program, developed disciplinary and corrective procedures to address violations that are detected.
To the best of our knowledge, Kastle is in compliance with our Compliance Program and the requirements of the California Health and Safety Code §§ 119400-119402 as of May 23, 2017. Kastle will evaluate and update our Compliance Program, as necessary and appropriate.
Kastle is committed to the highest standards of business conduct and ethics in its relationships with customers, healthcare professionals, employees, contractors, investors and the business community, as well as with state, federal and foreign governments (if applicable). Consistent with our understanding of the California Health and Safety Code, this declaration is limited to those activities undertaken by Kastle that are directed to California. Kastle makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the OIG Guidance, which gives broad discretion to manufacturers in the development, design and definition of the scope of compliance programs.
Copies of this Declaration and a description of our Compliance Program may be obtained by contacting the Kastle corporate headquarters at (312) 883-5700.
Kastle is committed to conducting all of our activities in compliance with applicable laws and ethical standards. We believe we have developed and implemented an effective Compliance Program that is appropriately tailored and scaled to our company, and we will continue to work to improve our Compliance Program and all of our compliance-related activities, as appropriate.