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Corporate Compliance & Policy Statement

LUITPOLD PHARMACEUTICALS, INC. CORPORATE COMPLIANCE PROGRAM

 

Luitpold Pharmaceuticals, Inc. has implemented a Corporate Compliance Program based on the fundamental elements described in the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers ("OIG Guidance"). Our Corporate Compliance Program is a key component of our commitment to the highest standards of corporate conduct. The Corporate Compliance Program is reasonably designed to foster compliance with applicable laws and regulations; the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals ("PhRMA Code"); and other requirements relevant to our business. The fundamental elements of our Corporate Compliance Program are described in greater detail below. Because our Corporate Compliance Program is dynamic, we review and enhance the Corporate Compliance Program to meet evolving compliance standards.

 

Overview of Corporate Compliance Program

 

1. Compliance Officer & Compliance Committee

Luitpold has a Compliance Officer responsible for implementing, operating and monitoring the Corporate Compliance Program. Luitpold has also established a Corporate Ethics & Compliance Committee charged with assisting the Compliance Officer and overseeing the operation of the Corporate Compliance Program.

 

2. Written Standards

Our Code of Conduct is a statement of ethical and compliance principles that guide our daily operations. The Code of Conduct also establishes that we expect management, employees, and agents of Luitpold to act in accordance with law and applicable company policies, procedures and guidelines. The Code of Conduct is supplemented by policies, procedures and other guidelines that address compliance risk areas, including areas identified in the OIG Guidance and PhRMA Code.

 

3. Education and Training

Luitpold is committed to communicating our standards, policies, procedures and guidelines to our employees. We provide education and training to new and current employees on a variety of compliance-related topics. Training programs are updated periodically and additional areas of training are added from time to time.

 

4. Internal Lines of Communication

Luitpold is committed to fostering open communication between management and our employees and agents. To that end, Luitpold has contracted with an independent third party to operate a confidential hotline available to all employees, vendors, customers, contractors and the public designed to encourage them to ask questions or report concerns without fear of retribution. The number is 1-800-398-1496 or reports can be made at www.lighthouse-services.com/luitpold. Luitpold also encourages employees to bring questions or concerns directly to their manager, Human Resources, or the Compliance Department.

 

5. Auditing and Monitoring

Luitpold reviews and assesses business activities for compliance with applicable laws, regulations, guidelines, and company policies and procedures. Corrective action plans are developed to address concerns identified through these reviews.

 

6. Disciplinary Guidelines

Luitpold takes disciplinary action in response to violations of applicable laws, regulations, guidelines and company policies and procedures. Disciplinary action may include warnings, suspension, termination and other sanctions, as appropriate.

 

7. Corrective Action

Luitpold responds appropriately to address issues that are identified or reported. Appropriate corrective action may be taken, including disciplinary action, training, and improvement of policies and procedures.

 

CALIFORNIA HEALTH & SAFETY CODE §§ 119400-119402

Luitpold has established an annual dollar limit of $2,500.00 for applicable spending on individual health care professionals licensed by the state of California in accordance with California Health & Safety Code §§ 119400-119402. This dollar limit represents a spending maximum and not an average or goal. Luitpold reserves the right to change this limit at any time.

 

For a copy of our Corporate Compliance Program and/or annual written declaration of compliance with California Health & Safety Code §§ 119400-119402, please call 1-800-398-1496.

 

JULY 1, 2016 DECLARATION OF COMPLIANCE WITH CALIFORNIA HEALTH & SAFETY CODE §§ 119400-119402

 

To our knowledge, and based on our good faith understanding of the statutory requirements, Luitpold Pharmaceuticals, Inc. declares that it is in compliance in all material respects with our Corporate Compliance Program and the requirements of California Health & Safety Code §§ 119400-119402.