Compliance

Introduction

Kaléo is a pharmaceutical company dedicated to putting a new generation of life-saving personal medical products in patients’ hands. Kaléo is committed to conducting its business ethically and in compliance with all applicable laws, regulations, guidelines, and policies. In keeping with that commitment, kaléo has implemented a comprehensive compliance program for their US operations (CCP); this document describes that CCP.

Elements of the Compliance Program

As per the guidance of the Office of Inspector General (OIG), the kaléo CCP establishes:

  1. Written policies and procedures
  2. A designated Compliance Officer and Compliance Committee
  3. An effective training and education program
  4. Effective lines of communication
  5. Monitoring and auditing protocols
  6. Enforcement standards through well publicized disciplinary guidelines
  7. Protocols for prompt responses to detected problems and undertaking corrective actions

Compliance Officer

The Compliance Officer is responsible for overseeing the administration and implementation of the kaléo CCP and will report at least quarterly on the Compliance Committee. The Compliance Officer has authority to direct and implement compliance-related changes and to determine the corporate response to compliance-related matters.

Compliance Committee

Kaléo has established a Compliance Committee and the committee meets on a quarterly basis. The Compliance Committees is responsible for ensuring the implementation and effectiveness of the Compliance Program, and to provide advice and support to the Compliance Officer.

Compliance Policies

Kaléo policies and procedures were developed to ensure that interactions with healthcare professionals are appropriate, ethical, and consistent with applicable laws and standards. Kaléo expects its employees to comply with the CCP, its Code of Ethics and Business Conduct, policies, procedures, and all applicable laws. Employees must annually acknowledge their responsibility and commitment to conduct kaléo’s business consistent with these standards and to report to real or suspected violations. Employees who violate these standards are subject to appropriate disciplinary action, up to and including termination. Kaléo’s policies prohibit retaliation against any employee for making a good faith report.

Training Program

Kaléo has implemented a training program for employees regarding obligations and responsibilities under the CCP and Code of Conduct as they apply to specific job functions. New employees receive training as part of their initial on-boarding and all employees receive compliance training on a periodic basis. Kaléo provides additional training on an as- needed basis.

Communicating Compliance Issues and Concerns

Kaléo is committed to an environment in which open communications is encouraged, including questions or concerns about the CCP. Employees are required to report anyactivity or individual that is suspect or in violation of the CCP. Employees may contact direct managers, the Compliance Officer or use the Compliance Hotline 877-338-3039. The Hotline is available 24 hours a day/7 days a week to allow confidential and anonymous reporting. The Helpline is administered by an independent outside contractor.

Monitoring, Auditing, and Investigations

The CCP includes activities designed to monitor and audit compliance with Kaléo’s policies and procedures. The Compliance Officer oversees monitoring and auditing through audit plan, including internal and external auditing activities. The Compliance Officer works with relevant resources to evaluate audit findings and ensure the implementation of any corrective action. The Compliance Officer (or designee) reviews and evaluates concerns to determine the required investigative response.

Corrective Action and Discipline

If it is determined that noncompliant conduct has occurred, appropriate parties are responsible for corrective and/or disciplinary actions. Kaléo’s disciplinary actions may include the following: termination; disciplining any involved employee(s); disciplining supervisor for failure to monitor employees appropriately. Kaléo’s corrective and preventative actions may include: revising the CCP, policies, and/or procedures; revising the role of the Compliance Committee; increased auditing and monitoring; revising the training program.

Updating the Compliance Program

As kaléo evolves as a company and as regulations changes, it may amend its CCP. The Compliance Committee reviews and approves all suggested changes. The Compliance Officer shall be responsible for communicating changes in the CCP to employees.

California Declaration

Declaration Under Cal. Health & Safety Code § 119400-119402

Kaléo is committed to compliance with applicable regulations and authorities in the promotion, distribution and marketing of its products. In order to achieve these goals kaléo has implemented a Comprehensive Compliance Program (CCP) consistent with Cal. Health & Safety Code § 119400-119402, based on its good faith understanding of the statutory requirements.

As recommended in the OIG Guidance, Kaléo’s CCP has been tailored to the unique characteristics and needs of the Company. While the OIG Guidance recognizes that even an effective compliance program may not completely eliminate all misconduct by individuals, kaléo’s CCP is designed to prevent and detect violations. Kaléo’s expectation is that all employees will adhere to company policies with regard to Federal and state regulations and will implement disciplinary and corrective actions when misconduct is identified.

Kaléo encourages individuals to report actual or suspected wrongdoing, and violations of laws, rules, regulations, company ethical standards, or any other irregularities. A Compliance Hotline has been established for compliance reporting purposes and is available at all times by calling 877-338-3039. The Hotline is operated by an independent, external service provider offering the caller continuous access and complete confidentiality and anonymity, consistent with the CCP.

In accordance with California requirements, kaléo has established an annual spending limit of two thousand dollars ($2,000.00) per California licensed Health Care Professional (HCP) and intends to monitor employee activities to ensure compliance. Additionally, kaléo’s CCP is available to individuals who request it by contacting vickie.templeman@kaleopharma.com (804) 545-6360.

Kaléo’s CCP includes annual audits and assessments for purposes of this declaration. Kaléo declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code § 119400 and 119402, as of August 28, 2017, Kaléo believes that it is in compliance with its CCP.

Sharps Disposal Plan

kaléo, Inc. supports the safe collection and proper disposal of waste from self-injected at home medications that include sharps. View our kaléo Sharps Plan here.

Code of Business Conduct and Ethics

Code of Business Conduct and Ethics 2015 April