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Global Compliance Program

PTC is committed to bringing hope to patients living with rare diseases through the development and commercialization of novel treatments. PTC conducts activities in accordance with applicable laws and regulations and is committed to acting honestly, ethically, and fairly.

The PTC Global Compliance Team

PTC’s designated Chief Compliance Officer is responsible for overseeing our Global Compliance Program including but not limited to all of its elements to help ensure compliance with applicable laws, regulations, and industry codes. Further, PTC has established a Compliance Committee charged with operating and monitoring the program. The Chief Compliance Officer has full access to the Board of Directors and the Audit Committee on a regular or as-needed basis.

We strive to be a valued partner across the organization to enable fast and sustainable access to our medicines for patients in need, in an ethical and compliant manner.”

The PTC Global Compliance Program

Our Global Compliance Program incorporates the elements of an effective compliance program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” developed by the United States Department of Health and Human Services, Office of Inspector General (“OIG”) and other laws and regulations that govern our industry.

The program is designed to help prevent non-compliance with company policies and the laws and regulations applicable to the pharmaceutical industry, as well as detect and correct non-compliance.

Review our Code of Business Conduct and Ethics

Additional Information About the PTC Global Compliance Program

Written Policies and Procedures

PTC maintains written policies and procedures to address legal, regulatory, and other requirements. Policies are assigned to employees and agents acting on its behalf and require acknowledgment of having read and understood the policy. All policies are made available to employees via the company’s document management system and are updated regularly. It is PTC’s expectation that all employees and agents comply with the policies that support The Program.

Additionally, PTC has established a Code of Business Conduct and Ethics, which has been developed to assist the company in fulfilling its commitment to patients while acting with integrity. The Code contains principles and standards to guide our business behavior throughout the world.

Effective Lines of Communication

PTC provides multiple channels for asking questions and raising potential compliance concerns. Our process includes measures that create a workplace atmosphere without fear of retaliation by making available avenues for reporting concerns via a non-retaliation policy for matters raised in good faith. Employees are urged to raise concerns about any potential violation of law, regulations, PTC policies, procedures or Code of Business Conduct and Ethics without fear of retaliation and with the assurance that the matter will be kept as confidential as possible.

Employees are encouraged to raise concerns to their immediate manager. Concerns may also be raised with other managers within the Compliance, Legal, or Human Resources departments. Alternatively, reports may be made via PTC’s confidential hotline provider, EthicsPoint. Reports may be made by phone or online via the web-reporting tool. The hotline is accessible 24 hours a day, 7 days a week, 365 days a year and is offered in multiple languages.

Internal Monitoring and Auditing

PTC routinely conducts internal monitoring and auditing of its business as part of the program. These efforts help to prevent and detect non-compliance with laws, regulations, or policy. Activities are documented and presented to PTC’s senior management and other employees as applicable. Any identified remediations or recommendations for improvement are communicated with support from the Compliance Department.

Enforcing Standards Through Disciplinary Guidelines

PTC’s Code of Business Conduct and Ethics as well as its internal policies sets the tone for PTC’s compliance standards. Failure to adhere to compliance standards may result in disciplinary measures up to and including termination of employment.

Responding Promptly and Undertaking Corrective Action

All matters raised are assessed for seriousness of the allegations, responded to promptly, and investigated in a timely manner. Appropriate corrective action may include disciplinary action, enhanced training, improvement of policies and procedures, or reporting obligations to governmental authorities.

Effective Training and Education

PTC requires regular compliance training for all applicable employees as part of the program.

PTC is committed to providing effective compliance training to all employees and agents acting on its behalf as well as select third parties. Our training program consists of live and web-based training in addition to policies and guidance documents. Training topics include but are not limited to PTC’s Code of Business Conduct and Ethics, Anti-Corruption Policy, Global Interactions with Healthcare Professionals Policy, and PTC’s confidential hotline for raising questions or concerns. Compliance policies, training and education are tailored to the audience and translated into local language as necessary.

Raise a Concern via Our Confidential Hotline Online