VERNALIS THERAPEUTICS, INC.’S CORPORATE COMPLIANCE PROGRAM
Vernalis Therapeutics, Inc. (VTI) is committed to ensuring that all business operations and activities that VTI is involved with are conducted in accordance with the highest of ethical standards. VTI considers its reputation within the medical community a valuable asset and, as such, is committed to promoting the honest and ethical behavior of all individuals employed by VTI.
Compliance with all laws, regulations, company policies and other best practices applicable to the organization by all VTI employees is a critical component of our professional standards and contributes to our corporate success. VTI’s Compliance Program incorporates the fundamental elements addressed within the Office of the Inspector General’s (OIG) “Compliance Program Guidance for Pharmaceutical Manufacturers,” and includes the following:
- Written Policies and Procedures
VTI has adopted policies, procedures, training programs and mechanisms to promote an atmosphere of open, honest and ethical communication throughout VTI.
VTI has also developed a Code of Business Conduct and Ethics to guide its business practices in an ethical and compliant manner. VTI expects all its employees and executives to abide by this Code.
In addition, VTI has implemented written policies and procedures to address risk areas identified in the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers.
- Corporate Compliance Officer (CCO) and Compliance Committee
VTI has designated a Compliance Officer (CCO) who is primarily responsible for oversight of the Compliance Program, but all employees play an important role in building and supporting the Compliance Program for VTI. The CCO oversees the Compliance Program and is primarily responsible for ensuring that all employees, directors and officers act in an ethical, compliant and professional manner.
VTI has established a Compliance Committee consisting of representatives from each business function within VTI. The Compliance Committee assists the CCO in overseeing and providing guidance over VTI’s Healthcare Compliance Program with regard to adherence to laws and regulations applicable to its business operations and activities; compliance with VTI’s Code of Business Conduct and Ethics; and compliance with healthcare compliance policies and procedures by all employees and officers of VTI. The Committee also assists the CCO in ensuring the effectiveness, and communicating the value and importance of, the Corporate Compliance Program and its requirements.
- Training and Education
Appropriate training and education are essential to reinforcing VTI’s compliance and ethical standards as well as providing personnel with the resources they need to understand and effectively abide by all legal, regulatory and healthcare compliance requirements. We train our personnel on our Code of Business Conduct and Ethics and appropriate job-related policies, procedures and other guidelines. Our training program and materials are updated on an as-needed basis.
- Effective Lines of Communication
VTI encourages an atmosphere of open communication that fosters dialog between management and employees regarding compliance or ethical concerns or reporting suspected misconduct. Our employees are encouraged to report concerns to management and/or the compliance hotline and we have implemented policies and procedures to ensure any reported concerns will not subject the individual to retaliation or retribution.
- Monitoring and Auditing
Monitoring and auditing of business activities are essential components of a Corporate Compliance Program. VTI has implemented policies and procedures to ensure that business processes and operations are efficient and effective as well as conducted in compliance with applicable regulations and industry requirements. VTI’s CCO is responsible for ensuring that the elements of the Compliance Program are audited and monitored on an ongoing basis.
- Enforcement and Discipline
VTI develops and maintains documentation that informs all employees of its dedication to, and enforcement of, ethics and compliance policies governing each employee’s day-to-day responsibilities and the consequences of violations of these policies. Any employee who fails to abide by these ethics and compliance standards may be subject to appropriate disciplinary action following an investigation.
- Response and Corrective Action for Detected Problems
Prompt responses and corrective actions for identified and confirmed compliance violations are necessary and appropriate to ensure the effectiveness of the compliance program. All employees are expected to report any suspected compliance issues or concerns they may have through our Compliance Hotline or other lines of reporting. All reported compliance issues will be reviewed, investigated and remedied as considered appropriate on a case-by-case basis.
VTI is committed to ensuring compliance with Company policies and applicable laws and regulations to preserve the Company’s reputation, ensuring the safety of its customers, and continuing to be successful. This is all possible because of the Company’s dedication to compliance with all applicable laws and regulations and Company policies. VTI is committed to establishing and maintaining a culture of compliance to prevent, detect, and resolve any activities or interactions that may not conform to its standards of compliance and business conduct.
To request a copy of VTI’s Comprehensive Compliance Program please email firstname.lastname@example.org.
VERNALIS THERAPEUTICS, INC. DECLARATION OF COMPLIANCE
Vernalis Therapeutics, Inc. (VTI), based upon a good faith belief and understanding of legal requirements, hereby declares that it has adopted a Comprehensive Compliance Program compliant with the requirements of California Health and Safety Code §§119400-119402. VTI 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 its knowledge and based on a good faith belief, VTI is in compliance with its Comprehensive Compliance Program. July 26, 2017.
VTI's compliance hotline number: 1-855-229-9304