Compliance

Compliance
Zyla Life Sciences is committed to establishing and maintaining an effective Compliance Program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”). Zyla’s Compliance Program (“the Program”) includes development, communication and training of policies and procedures, performance of periodic compliance audits and monitoring activities, maintenance of mechanisms to foster open communication throughout Zyla, and tracking and investigation of alleged or suspected non-compliance. The purpose of the Program is to prevent, detect, and remediate violations of law, regulations, or Zyla policies, and to promote a culture of the highest ethics within the organization. The program is regularly evaluated for effectiveness and the need for continuous improvement. It is Zyla’s expectation that employees will comply with our Code of Conduct and the policies established in support of such code. As the HHS-OIG Guidance recognizes, the implementation of such a Program cannot guarantee that improper employee conduct will be entirely eliminated. In the event that Zyla becomes aware of violations of law or Zyla policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.

California Compliance Law
NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program.

Zyla declares that, to the best of its knowledge, and based on a good faith understanding of the legal requirements of California Health and Safety Code § 119400 and 119402, we have adopted a Comprehensive Compliance Program with respect to our business and operations in the State of California as mandated by this California law. Zyla has tailored its Comprehensive Compliance Program to its current size and business operations and continues to develop and implement changes to the Comprehensive Compliance Program as compliance and operational needs evolve. To the best of our knowledge and based on a good faith belief, Zyla is in compliance with its Comprehensive Compliance Program. In accordance with California Health and Safety Code §§ 119400-119402, Zyla has established an annual dollar limit of $2,500 on meals associated with educational presentations, educational items, promotional materials and or other items of value that Zyla may provide to medical or health care professionals in California, as defined in the California statute.

Commitment to Transparency
At Zyla we are focused on delivering safe and effective pain medicines to patients and physicians. To ensure the availability of new treatment options, we may work and innovate with other individuals and organizations including physicians and teaching hospital. We are fully committed to the financial transparency of these relationships and to prevent any real or perceived conflict of interest.

Under federal law and implementing regulations (now referred to as “Open Payments”), issued by the Centers for Medicare and Medicaid Services (CMS) any payment or other transfer of value we make to a physician or teaching hospital is subject to collection and potential public reporting. Certain states have also enacted laws and regulations relating to transparency of interactions with healthcare professionals which often cover additional categories of healthcare professionals and are separate and in addition to the federal transparency reporting requirements. We are committed to complying with state and federal laws and regulations today and in the future. Inquiries should be directed to Zyla Compliance at (610) 833-4200.

Reporting Suspected Violations
Every Director and employee has a responsibility to report any suspected violations of this code of conduct, any other company policy or code of behavior, or any violation of law, regulation or ethical principles that occur within Zyla. Every Director and employee may make such reports without fear of retaliation, and should refer to our policy (discussed herein and in Zyla’s Speak Up & Non-Retaliation Policy) prohibiting retaliation for various actions done in good faith. In most cases, employees should discuss a possible violation with their immediate supervisor, Human Resources and/or Compliance and Directors should discuss a possible violation with the Chair of the Audit Committee. However, if you believe that your concerns cannot be addressed in this manner, you may report suspected violations of Zyla’s code of conduct by calling Zyla’s Ethics hotline. The Ethics hotline number has been made available to all Zyla Directors and employees via Zyla’s Speak Up & Non-Retaliation Policy. At your option, you may identify yourself or remain anonymous. Reports can be made, at any time, confidentially and anonymously:

Via the Zyla Life Science Ethics hotline:

In writing to Zyla Compliance:
600 Lee Road
Wayne, PA 19087

Should an individual not be comfortable speaking with Zyla Compliance, or is not satisfied with Zyla Compliance’s response, the individual is encouraged to contact the Chair of the Audit Committee in writing at the address above. The Ethics hotline is managed by an outside, independent service provider and all calls will be treated (to the extent possible) confidentially and, if requested, anonymously. Identity may have to be disclosed to conduct a thorough investigation and to comply with legal requirements. Where we have a separate policy that provides for reporting of a suspected violation of that policy, you may follow the reporting procedures in that policy or in the Code of Conduct

Product Complaints and Adverse Event Reporting
Zyla has implemented procedures which allow product complaints and adverse event information to be reported to the company. This may include information regarding an adverse event experienced by a patient who is currently using, or who recently used, a Zyla product. The procedures in place allow product complaints and adverse event reports to be documented and handled in accordance with applicable laws and regulations. Directors and employees who become aware of an adverse event or product complaint must report it by calling 1-800-518-1084 within one (1) business day of becoming aware of the potential adverse event or product complaint.

Transparency in Supply Chain’s Act Disclosure
Zyla is committed to ensuring that our supply chain reflects the Company’s values and respect for human rights and the environment. Zyla’s relationships with suppliers are based on lawful, efficient and fair practices. We expect our suppliers to obey the laws that require them to treat workers fairly, provide a safe and healthy work environment and protect environmental quality. In furtherance of this policy, Zyla obligates its suppliers by contract to comply with all applicable laws and regulations, including those relating to slavery and human trafficking of the country or countries in which they are doing business.

For more information, visit http://Zyla.investorroom.com/code-of-conduct


 

 

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ZYLA LIFE SCIENCES

U.S. Operations
600 Lee Road, Suite 100
Wayne, PA 19087
Tel: 610.833.4200

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