Comprehensive Compliance Program

Aptalis Pharma US, INC. 2012 Declaration of Comprehensive Compliance Program

Aptalis Pharma US, Inc. (Aptalis) is committed to doing business in accordance with the highest standards of business conduct and ethics. We consider our reputation for ethical and compliant behavior to be a valuable corporate asset. Each employee of Aptalis is charged with the responsibility for safeguarding and strengthening that asset.

In furtherance of its commitment to ethical and compliant conduct, Aptalis has established, and abides by, a "Comprehensive Compliance Program" (CCP), as required by California law.

The Aptalis CCP is a dynamic program that both adaptable, and adapted, to the changing environment in which the company operates. Our CCP is continually evaluated to insure that it functions as intended; that it serves the purposes for which it was designed and helps enable the company to meet its high standards and commitment to compliance.

As recognized in the April 2003 Compliance Program Guidance for Pharmaceutical Manufacturers, published by the United States Department of Health and Human Services, Office of Inspector General, even an effective CCP cannot completely eliminate the possibility that individual employees engage in conduct that may violate the CCP or applicable laws, regulations or industry codes of conduct. It is with this recognition that the Aptalis CCP is designed, and operates, to detect such violations, investigate them promptly and thoroughly, provide an appropriate disciplinary response and, wherever possible, implement corrective measures to prevent future violations.

This Annual Declaration and the Aptalis CCP are publicly available on the company's website, http://www.aptalispharma.com. Copies of this Annual Declaration and the Aptalis CCP may be obtained by calling the following telephone number: 1-877-552-9226.

Dated: July 1, 2012

Annual Description of Comprehensive Compliance Program

California Health & Safety Code §§ 119400-119402

Overview of Aptalis Compliance Program
1. Leadership and Structure
  The Aptalis CCP has been developed, and is managed by, our Vice President, Chief Compliance Officer (CCO). Our CCO reports directly to our Chief Executive Officer and interacts routinely with our Management Team, which currently serves as the company’s Compliance Committee and meets on a monthly basis. Our CCO reports also to the Compliance Committee of our Board of Directors, which meets on a quarterly basis.
2. Policies and Procedures
  Aptalis has enacted written policies and procedures implementing its high ethical standards and meeting its healthcare compliance obligations under applicable laws, regulations and industry codes of conduct. These policies apply to all Aptalis employees and compliance with those policies is a condition of employment.
  One such policy is the Aptalis Code of Conduct, revised and updated in 2012. Each employee of Aptalis is required annually to certify that he/she has read, understands and agrees to comply with the Code of Conduct, and to disclose knowledge of any suspected or actual ethics or compliance issues, concerns or violations.
  
  Aptalis has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $1,200 annual limit on promotional spending per California healthcare provider.
3. Training and Education
  We provide ethics and compliance training to all Aptalis employees. We train on our Code of Conduct, company policies and applicable healthcare compliance laws, regulations and industry codes. We provide training to new employees, include compliance training in our initial sales training curriculum, and provide both annual and ad hoc compliance training as appropriate. We provide compliance guidance at company meetings and respond to compliance questions from employees.
4. Compliance Communications
  Aptalis is committed to maintaining a work environment where all individuals encourage and embrace open discussion across both geographical and operational boundaries. Employees are encouraged to seek guidance in resolving ethics and compliance questions. They can do so directly with the Compliance Department or by submitting their questions to the “Compliance Mailbox.” They are required to report suspected or actual unethical or non-compliant conduct, violations of law or regulation and violations of the Code of Conduct or Aptalis policies. Access is provided to an independent, third-party operated, Compliance Hotline where employees can make such reports anonymously and without retaliation.
5. Auditing and Monitoring
  Aptalis performs compliance gap analyses, process reviews and data analysis to identify and address potential issues and opportunities to enhance its processes and practices. These are collaborative efforts between the Compliance Department and the business which have generated the development of new and revised policies, new training and communications initiatives and corrective action.
6. Investigating and Responding to Potential Violations
  The Aptalis Compliance Department monitors company functions and activities for potential violations of law, regulation, industry codes, the Code of Conduct and company policies. Potential violations are promptly and thoroughly investigated and appropriate corrective action taken.
7. Corrective Action
  In determining the appropriate response to an established violation, Aptalis considers various options for corrective action. These options include closing any gaps in policies, practices or training that may have led or contributed to the violation and the imposition of disciplinary action, up to and including termination.

To request a copy of the Aptalis Declaration and Comprehensive Compliance Program description, please call the Compliance Department, at 1-877-552-9226