Compliance Program

Introduction

Leading Edge is committed to conducting its business ethically and in compliance  with all applicable laws, regulations, guidelines and policies. In keeping with that commitment, the Company has  implemented a comprehensive  Compliance Program which governs its entire business operations.

Elements of the Compliance Program

A. Compliance Officer

The Company’s  Chief Compliance Officer is responsible for overseeing the implementation and administration    of the Compliance Program and reports  at least quarterly on Compliance Program operations to the Company’s  Compliance Committee. The Chief  Compliance Officer’s core responsibility is to direct and implement compliance-related changes in the organization and exercise independent judgment in assessing and implementing compliance-related matters. The Chief Compliance Officer is also charged with reporting compliance-related  issues directly to the organization’s senior management.

B. Compliance Committee

The Company has established a Compliance Committee  which meets at  least quarterly.  The mission of the Compliance Committee includes, among other things:

  • Ensure the implementation and effectiveness of all components of the Compliance Program;
  • Development  and implementation of  compliance-related policies, standards, and procedures in the organization;
  • Development and implementation of corrective and disciplinary action to address and prevent  recurrence of non-compliance; and
  • Provide advice, counsel and support to the Chief Compliance Officer.

C. Compliance-Related Policies

The Company has implemented  compliance-related policies that are consistent with the evolving business and strict regulatory environment. Leading Edge enforces compliance-related policies and expects its employees to fully comply with its Compliance Program. Any employee who violates  these standards is subject to appropriate disciplinary action, up to and including termination. The Company’s compliance policy expressly prohibits retaliation or retribution against any employee who reports or makes a good faith effort to report a suspected misconduct or improper behavior.

The organization’s compliance policies and procedures are designed to ensure that interactions with Healthcare Professionals are appropriate, ethical, and consistent with all applicable laws, regulations, guidelines, policies and standards. The Compliance program is designed following the framework laid out by the U.S. Department of Health and Human Services Office of Inspector General’s April 2003, publication “Compliance Program Guidance for Pharmaceutical       Manufacturers” (“OIG Compliance Guidance”) developed by the United State  Department of Health and Human Services Office of Inspector General (“OIG”), and the Pharmaceutical Research and Manufacturers of America (Pharma) “Code on Interactions with Healthcare Professionals,” revised effective January 2009, (“Pharma Code”). For a statement regarding compliance with California Health & Safety Code § 119402, click here.

D. Training and Educational Programs

The Company’s  Compliance Program includes training and educating employees regarding their general ethical obligations and  their specific obligations to comply with Company policies and procedures and with all applicable laws  and regulations. The training programs also involve educating employees on new and existing Corporate Policies, and on  the standards and procedures applicable to their job functions. New employees  receive compliance training as part of their initial training. Also, employees whose job functions involve interactions with Health Care Professionals receive on-going compliance training on a routine and periodic basis. Regularly scheduled update-training and tests are scheduled after the initial training to provide necessary reinforcement on compliance.

To ensure that the Company’s culture remains compliance-focused, management is involved in training and assessment to assure a consistent understanding of compliance throughout the  organization. High-level personnel in the Compliance and Regulatory Affairs departments are constantly assessing the training programs to ensure that any updates in the applicable laws and regulations are included and also to address any real or perceived short-comings in order to strengthen the overall effectiveness of the training programs.

E. Communicating Compliance Issues and Concerns

Leading Edge is  committed to fostering  an environment where open communication regarding the Company’s Compliance Program’s policies and procedures is encouraged. This includes, in particular, the airing of concerns and reporting of suspected improper practices. Any employee who has concerns about a particular activity that the employee feels may violate policies, or the law is required to report such concerns.  The Company is committed to open communication regarding compliance issues and employees are encouraged to ask questions about compliance matters. Employees may either report their concerns to their managers or to any member of either Compliance, Legal or Human Resource Departments, including  the Organization’s Chief Compliance Officer or any member of the Special Compliance Committee   of the Board of Directors. The Company has also established a toll free number 800-000-000 which allows confidential anonymous reporting  of suspected compliance violations. Employees may also email or call the Chief Compliance Officer directly.

F. Monitoring, Auditing, and Investigations

The Compliance  Program includes activities designed to monitor, audit and ensure compliance with the Company’s policies and procedures. The Chief Compliance Officer oversees and/or   coordinates periodic monitoring and auditing to ensure adherence to applicable policies. The Chief Compliance Officer is charged with developing an annual audit and monitoring plan which is subject to reassessment and refinement in the course of the year to address unforeseen issues. A variety of internal and external auditing and monitoring resources are used to conduct those activities periodically. The Chief Compliance Officer works with relevant internal and external experts and management to evaluate auditing and monitoring findings and ensure the implementation of any corrective action deemed necessary as a result of audits or routine monitoring activities.

The Chief Compliance Officer reviews and evaluates concerns communicated to  the Compliance Department to determine whether further investigation        is required of activities that may be inconsistent with the policies and procedures of the   Compliance Program or applicable law(s). The Chief Compliance Officer  may, as necessary, request assistance from the members of the Compliance Committee  or outside experts  to investigate, depending on the nature of the alleged misconduct. Investigations are conducted confidentially to the greatest extent  possible and with every effort to respect the rights of all concerned.

G. Corrective Action and Discipline

If after investigation it is determined that noncompliant  conduct occurred, the matter is forwarded to the appropriate parties   for corrective and/or disciplinary action. Such response and disciplinary action may include, but not limited to :

  • Terminating or otherwise disciplining the employee(s) involved;
  • Disciplining supervisors in accordance with the facts for failure to supervise adequately and control the behavior of the employee(s);
  • Revising guidelines, policies, and procedures or any function of the Compliance Program to prevent the recurrence of misconduct in the area; increasing auditing and monitoring procedures;

H. Updating the Compliance Program

The Company evaluates and amends its  Compliance Program periodically to reflect changes in regulations and the overall regulatory environment. The Chief Compliance Officer reviews all changes suggested for implementation. The Chief Compliance Officer is responsible for communicating changes in the Compliance Program to Company employees in a timely manner.

For a written copy of the Compliance Program description, Email:  compliance@leadingedge.com