Corporate Compliance

  1. Corporate Compliance

Sebela Pharmaceuticals Inc. (“Sebela Pharma”) maintains a comprehensive, and effective Corporate Compliance Program (the “Corporate Compliance Program”) in accordance with all federal, state, and industry guidelines, including the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of Inspector General , U.S. Department of Health and Human Services (the “HHS-OIG Guidance”), the Pharmaceutical Research and Manufacturers of America’s (PhRMA) “Code on Interactions with Healthcare Professionals” (the “PhRMA Code”) and the California Health & Safety Code sections 119400-119402 (SB 1765). Our Corporate Compliance Program reflects our unwavering commitment to the highest standards of corporate conduct and integrity.

  1. Overview of the Comprehensive Compliance Program

The Sebela Pharma Corporate Compliance Program, described in further detail below, contains policies, procedures and processes to address risk areas identified in the HHS-OIG Guidance and the PhRMA Code. As recommended by the HHS-OIG Guidance, the Sebela Pharma Corporate Compliance Program has been designed to fit the specific compliance needs of the company. Sebela Pharma will regularly review and evaluate its Corporate Compliance Program to ensure it continues to meet the evolving needs of our company.

Key Elements of the Sebela Pharma Corporate Compliance program include:

  • Appointment of a Chief Corporate Compliance Officer who reports directly to Sebela Pharma’s Board of Directors
  • A Corporate Compliance Committee
  • A Sales and Marketing Code of Conduct
  • Availability of anonymous reporting option for raising compliance concerns
  • The conduct of annual audits to monitor compliance with the Corporate Compliance Program and Sales and Marketing Code of Conduct
  • Routine training of employees on the Corporate Compliance Program and Sales and Marketing Code of Conduct
  • Reporting transfers of value and payments made to Healthcare Professionals and Healthcare Organizations (“Sunshine Act”).
  1. Corporate Compliance Officer and Corporate Compliance Committee

Sebela Pharma has designated a Corporate Compliance Officer who is charged with the responsibility of developing, implementing, monitoring, and updating the Sebela Pharma Corporate Compliance Program. The Corporate Compliance Officer has the authority to effectuate change and exercise independent judgment within the company. Additionally, the Corporate Compliance Officer reports directly to the Board of Directors.

Sebela Pharma has also established a Corporate Compliance Committee comprised of senior management personnel from a variety of business units. The Corporate Compliance Committee advises and assists the Corporate Compliance Officer in the development, maintenance and updating of the Corporate Compliance Program.

  1. Written standards

Sebela Pharma has established written policies and procedures to ensure compliance with the “PhRMA Code”, including the Sebela Pharma Corporate Compliance Program and Sales and Marketing Code of Conduct and other complementary policies that outline the company’s commitment to compliance and corporate accountability.

  1. Education and Training

All employees are required to receive compliance training applicable to their job function and responsibilities, which includes training on the Corporate Compliance Program and complementary policies. In addition, further specialized training may be provided where a need for additional training has been identified. Annual compliance training is required of all employees. Sebela Pharma regularly reviews and updates its training programs to help ensure it continues to meet the educational needs of its employees.

  1. Effective Lines of Communication

Sebela Pharma is committed to open dialogue between management and employees. Our goal is to foster an open door policy to encourage employees to ask questions or report potential instances of inappropriate activity without fear of retaliation. We have established a confidential and anonymous Compliance Hotline number that is available 24 hours a day, seven days a week for making good faith reports of known or suspected violations.

  1. Auditing and Monitoring

Sebela Pharma recognizes that a comprehensive auditing and monitoring plan is critical to maintaining the effectiveness of a Corporate Compliance Program. The subject of our auditing and monitoring assessments, as well as the extent and frequency of our reviews, may vary according to a variety of factors, including new regulatory requirements, changes in business practices and other considerations.

  1. Responding to Potential Violations

The purpose of our Corporate Compliance Program is to prevent and detect violations of law or company policy. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is Sebela Pharma’s expectation that all employees will comply with the Corporate Compliance Program, and the policies established in support of such program. All Sebela Pharma employees have a duty to promptly report any violation of the Corporate Compliance Program or any company policies using any of the available company resources.   In the event that Sebela Pharma becomes aware of violations of law or company policy, we will promptly investigate the matter and take appropriate corrective action to ensure the integrity of the Corporate Compliance Program and prevent future violations. Personnel who violate Sebela Pharma’s policies and procedures and applicable state and federal laws may be subject to disciplinary action up to and including termination.

  1. Annual Aggregate Dollar Limit in California

Sebela Pharma does not permit gifts, promotional materials, items, or activities that are prohibited by the PhRMA Code, HHS-OIG Guidance, or FDA regulations. For items and activities that are not prohibited, Sebela Pharma has set an annual aggregate spending limit of $1,500.00 per healthcare professional, as required by California SB 1765. This amount represents an upper limit rather than a spending goal or a usual, customary or typical amount for medical or healthcare professionals. This limit excludes amounts attributable to drug samples, financial support for continuing medical education, or payment at fair market value for legitimate professional services. In setting this limit, Sebela Pharma has taken into account the size of the company and its portfolio and will revise this limit as the company and or product portfolio changes.

  1. Sebela Pharma Declaration of Compliance

Sebela Pharma declares that, to the best of its knowledge and based on a good faith understanding of the statutory requirements, for the period commencing of January 1, 2015, to December 31, 2015, it is in compliance with its Corporate Compliance Program, including its established annual aggregate spend limit of $1,500.00 and the requirements of California Health and Safety Code sections 119400-119402 (SB 1765).

Sebela Pharmaceuticals Inc. is committed to the maintenance and ongoing assessment necessary to ensure an effective Corporate Compliance program. This Corporate Compliance Program may be amended, altered or revised from time to time as needed and without prior notice.

To obtain a printed copy of the Corporate Compliance Program or the Declaration of Compliance please call (844) 732-3521 or email info@sebelapharma.com.