Par Pharmaceutical, Inc. is committed to establishing and maintaining an effective compliance program in accordance with (a) the "Compliance Program Guidance for Pharmaceutical Manufacturers" dated April 23, 2003 and issued by the Office of Inspector General, U.S. Department of Health and Human Services on May 5, 2003 (the "OIG Guidance") and, as applicable, (b) the Pharmaceutical Research and Manufacturers of America voluntary guideline entitled "Code of Interactions with Health Care Professionals," dated July 1, 2002 (the "PhRMA Code"). Our Compliance Program is one of the key components of our commitment to the highest standards of corporate conduct.
The purpose of our Compliance Program is (a) to provide appropriate training to management, employees and agents and (b) prevent and detect violations of law and Company policy. As acknowledged by the OIG Guidance, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. It is Par's expectation that our employees will comply with our Code of Conduct/Ethics (the "Code") and other relevant policies. In the event that Par becomes aware of violations of law or Company policy, we will investigate the matter and, as appropriate, take disciplinary action and implement corrective measures to prevent future violations.
The fundamental elements of our Compliance Program are described below. Consistent with the OIG's recommendation, Par's Compliance Program has been established consistent with the unique environment that exists at Par. Further, our Compliance Program is dynamic; we are presently engaged in a review of our Compliance Program to meet our evolving compliance needs and will engage in such reviews on an going basis in order to enhance our Compliance Program.
California Residents: A copy of the description of the Compliance Program, Par's Declaration of Compliance and related materials may be obtained by calling Par at 1-800-828-9393, prompt 4 and then prompt 4.
B. Summary of Compliance Program
(1) Leadership and Structure.
(a) Compliance Officer. We have selected a senior member of management to serve as our Ethics Officer or Compliance Officer. We are committed to ensuring that the Ethics Officer has the ability to effectuate change within the Company as necessary and to exercise independent judgment. The Ethics Officer, among other responsibilities, is charged with developing, operating and monitoring the Compliance Program.
(b) Compliance Committee. Par is establishing a Compliance Committee to advise the Ethics Officer and assist in the implementation of the Compliance Program.
(2) Written Standards.
(a) Par's Code of Conduct/Ethics is our statement of ethical and compliance principles that guide our daily operations. The Code establishes that we expect management, employees and agents of the Company to act in accordance with law and Company policy. The Code articulates our fundamental principles, values and framework for action within our organization. A copy of our Code is available by clicking through the link at the bottom of this document.
(b) The OIG Guidance identified several key risk areas for pharmaceutical manufacturers and called on companies to develop compliance policies in these risk areas. These risk areas are (1) data integrity pertaining to government reimbursement practices; (2) kickbacks and other illegal remuneration; and (3) compliance with laws regulating sampling activities. Par has established policies that address data integrity, kickbacks and sampling activity.
(c) In response to a law recently enacted in California we have also established annual spending limits for certain promotional activities directed towards health care professionals. More specifically, the promotional activities referenced in the preceding sentence shall not exceed the sum of One Thousand Eight Hundred Dollars ($1,800.00). This $1,800 amount is an upper limit and addresses spending on health care professionals for occasional meals and snacks; meals provided in connection with a Company speaker program; any patient related gift; and any medically related textbook or journal. This amount does not include the value of pharmaceutical drug samples; grants for medical education; medical scholarships; professional service fees; pens and notepads valued at less than $15; patient education materials; and approved scientific reprints. An exception to this $1,800 amount may be made only upon the prior, written approval by Par's Vice President for Sales and Par's compliance committee. This limit may also be subject to other laws addressing interactions with government employees and health care professionals.
(3) Education and Training. Education of our employees and agents on their legal and ethical obligations is a key component of Par's Compliance Program. Par is committed to taking all necessary steps to effectively communicate our standards and procedures to all affected personnel. In addition, Par will regularly review and update its training programs and identify additional areas of training on an as needed basis.
(4) Open Lines of Communication. Par has a longstanding policy of fostering dialog between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know who to turn to for a meaningful response and should be able to do so without fear of retribution. To that end, Par has adopted an open door policy - "Lets Talk About It" - as well as confidentiality and non-retaliation policies
(5) Auditing and Monitoring. Par's Compliance Program includes efforts to monitor, audit, and evaluate compliance with the Company's compliance policies and procedures through internal and external resources.
(6) Discipline. Par has established disciplinary policies that set out the consequences of violating the law or Company policy. Although each situation is considered on a case-by-case basis, Par will impose appropriate disciplinary action to address inappropriate conduct and deter future violations.
(7) Corrective Actions. Par's Compliance Program increases the likelihood of preventing, or, at least identifying unlawful and unethical behavior. However, consistent with the OIG's comment, Par recognizes that even an effective Compliance Program may not prevent all violations. That being said, Par's Compliance Program requires that the Company respond promptly to all potential violations of law or Company policy, take appropriate disciplinary action, perform an assessment of the violation to ascertain if the violation reveals a gap in our policies, practices, or internal controls and take appropriate action to prevent future violations.
C. Par Pharmaceutical, Inc. Declaration of Compliance
Par Pharmaceutical, Inc. ("Par" or the "Company") hereby declares as follows:
To the best of our knowledge, and based on our good faith understanding of statutory requirements, Par has established a Comprehensive Compliance Program ("CCP") compliant with the requirements of California's Health and Safety Code (Section 119400 - 119402).
Par's CCP is tailored to the size, organizational structure and resources of the Company and has been developed to meet the issues addressed by the above mentioned California Law.
By making this declaration, Par is not asserting that it can prevent individual employees from improper conduct and/or otherwise violating the standards set forth in the CCP.
Par has established procedures to identify potential violations and will discipline employees as necessary.
As of the date of this declaration, such procedures are in place and will be reassessed periodically and no less frequently than on an annual basis.
D. Par Pharmaceutical, Inc. California Transparency in Supply Chains Act Disclosure
Par is committed to conducting its business in a lawful and ethical manner and expects its suppliers to conduct themselves in the same manner. The 2010 California Transparency in Supply Chains Act requires companies to disclose their efforts to eradicate slavery and human trafficking from their supply chain.
Currently we do not verify or audit whether or not our supply chain partners evaluate the risks of human trafficking and slavery. Nor do we require them to certify compliance with human trafficking laws. We do not maintain internal accountability standards or procedures for employees or contractors failing to meet the standards regarding slavery and trafficking. However, we are developing policies to address this issue and will provide training on human trafficking and slavery to relevant employees.
* Slavery is the status or condition of a person over whom any or all of the powers attaching to the right of ownership are exercised. (1926 Slavery Convention)
* Trafficking in persons shall mean the recruitment, transportation, transfer, harboring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labor or services, slavery or practices similar to slavery, servitude or the removal of organs. (United Nations: Palermo Protocol of 2000)
October 12, 2012