Compliance | kaléo

Compliance

 

Kaléo is a pharmaceutical company dedicated to putting a new generation of life-saving products in patients’ hands.  We are committed to conducting our business ethically and in compliance with all applicable laws, regulations, guidelines, and standards.  In support of our commitment, we have implemented a comprehensive Compliance Program that meets the expectations set forth in the U.S. Department of Health and Human Services, Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”) and the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Health Care Professionals.”  Below is an overview of kaléo’s Compliance Program.

Reporting a Concern or Violation

Kaléo wants to hear from its employees and others if there is something we can do better.  We have established a variety of ways for employees and others to report concerns about kaléo, its employees, or its business partners and how we are conducting our business.  The following avenues are available to you to ask questions and raise concerns:

  • We Have Open Doors: The company encourages all employees to discuss issues, concerns, and suggestions with their immediate supervisor or other managers without fear of retaliation or that confidentiality will be broken.
  • Contact the Compliance & Business Ethics Department Directly: Employees and others are encouraged to contact kaléo’s Compliance & Business Ethics Department directly with any questions or concerns. The Compliance & Business Ethics Department can be reached by phone at (804) 545-6360, email at compliance@kaleo.com, or mail at 111 Virginia Street, Suite 300, Richmond, VA 23219.
  • Contact the Compliance Hotline: The kaléo Compliance Hotline is always available for anyone to contact the company about a concern or to get information. It can be reached by calling (877) 338-3039 or visiting lighthouse-services.com/kaleopharma.  The Compliance Hotline is administered by an independent outside contractor to allow confidential and anonymous reporting. Though not required, those who contact the Compliance Hotline are encouraged to leave a name and phone number in case additional information is needed.

Elements of Our Compliance Program

As per the OIG Guidance, kaléo’s Compliance Program is based on the following fundamental elements of an effective compliance program:

1. Written Policies and Procedures

Kaléo’s policies and procedures are designed to ensure that interactions with healthcare professionals and others are appropriate, ethical, and consistent with applicable laws, regulations, and industry standards.  Kaléo expects its employees to abide by its Code of Business Conduct & Ethics, its policies and procedures, and all applicable laws and regulations.  Employees acknowledge their responsibility and commitment to carry out business consistent with these policies and standards.

2. Chief Compliance Officer and Executive Compliance Committee

Kaléo has a Chief Compliance Officer who is responsible for overseeing the Compliance Program.  In this capacity, the Chief Compliance Officer reports directly to the CEO and the Board of Directors, and regularly makes reports to the Executive Compliance Committee.  The Chief Compliance Officer is responsible for implementing and administering all aspects of the Compliance Program.  The Executive Compliance Committee provides advice and support to ensure that kaléo operates its business consistent with its commitment to compliance.

3. Effective Training and Education Program

Kaléo is committed to providing effective training to employees on its Compliance Program and other requirements.  We have implemented a training program to ensure employees learn and understand their obligations and responsibilities under the Compliance Program that apply to each employee’s specific job function.  New employees receive compliance training when they join the company, and all employees receive appropriate compliance training periodically and as needed.

4. Effective Lines of Communication

Kaléo is committed to an environment in which open communication is encouraged.  The Compliance & Business Ethics Department also regularly communicates with senior management and the Executive Compliance Committee about compliance matters.  The company encourages questions and concerns about the Compliance Program, and it has implemented anti-retaliation and confidentiality policies to encourage and protect employees who raise a valid concern.  We provide multiple channels for employees and others to ask questions and raise compliance concerns, including contacting our Compliance Hotline by calling (877) 338-3039 or visiting www.lighthouse-services.com/kaleopharma.

5. Monitoring and Auditing Protocols

In an effort to prevent and detect potential violations of law or policy, the Compliance Program includes activities designed to monitor and audit business processes and transactions.  The Compliance & Business Ethics Department oversees monitoring and auditing, and works with relevant resources to evaluate findings and ensure appropriate corrective action is taken.

6. Enforcement Standards Through Well Publicized Disciplinary Guidelines

Kaléo will take appropriate disciplinary actions in response to a violation of the company’s policies or procedures.  Our Code of Business Conduct & Ethics and other compliance policies put all employees on notice that failure to adhere to our compliance standards and requirements may have disciplinary consequences, up to and including termination of employment.  The company is committed to taking appropriate action when an investigation suggests that discipline is warranted.

7. Protocols for Prompt Responses to Detected Problems and Undertaking Corrective Actions

Kaléo requires a prompt and diligent response to potential violations of the Compliance Program.  The company is committed to thoroughly investigating issues in a timely manner and taking corrective action, such as improving policies, procedures, training, communications, and monitoring in response to potential or actual issues.

Updating the Compliance Program

As kaléo evolves as a company and as regulations change, the company may amend its Compliance Program.  The Executive Compliance Committee reviews and approves all suggested changes, and the Compliance & Business Ethics Department is responsible for communicating and training relevant employees on approved changes to the Compliance Program.

Compliance Initiatives

Code of Business Conduct & Ethics

Annual Declaration Under California Health and Safety Code, §§ 119400-119402

California Transparency in Supply Chains Act

Sharps Safe Collection and Proper Disposal Plan