Comprehensive Compliance Program
(As required by the California Health & Safety Code)
Sage Therapeutics is committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. This commitment requires novel and transformative ways of thinking and working together. We encourage Our People to think differently, challenge conventional wisdom, and foster innovation, while always being guided by the best interest of patients. In doing so, we are also committed to Our Values and the belief that they must be lived in a way that is respectful of each other, our stakeholders, and applicable laws, regulations, and industry standards. For this reason, we have developed a comprehensive Compliance Program that includes the following elements.
Oversight & Governance
Our Board of Directors is committed to sound corporate governance principles. As part of this commitment, it has designated its Audit Committee to establish expectations for, oversee, and evaluate the effectiveness of our Compliance Program. Sage has designated a Chief Compliance Officer to implement and oversee the Compliance Program that advances a culture of integrity and upholds Our Values. The Compliance Officer reports on a regular basis to the Audit Committee and to the General Counsel regarding the operations of all elements of the Compliance Program, including alleged violations and remedial or disciplinary measures.
Our Compliance Program is designed to address risks particular to our business activities. We assess various dynamics, including internal and external perspectives as appropriate, to continually update our Compliance Program in light of the risks in a changing market.
Our Values Code is designed to advance compliance with applicable federal and state laws and industry standards. The commitments in Our Values Code also include adherence to relevant industry codes, such as the PhRMA Code on Interactions with Healthcare Professionals. Our policies and procedures flow from Our Values Code and must be consistent with it.
As required by California Health & Safety Code section 119402, Sage has established an annual, aggregate dollar limit of $2,000.00 for certain spending on individual healthcare providers or other medical professionals licensed in the state of California. The value of meals provided in connection with business and educational discussions, and educational items, are included in this limit. This limit does not include the value of any drug samples intended for free distribution to patients, grants for medical education or research, sponsorships, or fair market value payments for professional services. This limit may be revised from time to time by Sage in its sole discretion. This limit represents an expenditure cap and not a goal or an average expenditure amount.
To the best of our knowledge, as of May 1, 2023, Sage is in material compliance with its comprehensive Compliance Program and the requirements of the California Health & Safety Code section 119402.
Training & Communication
All Sage employees are trained on Our Values Code and the policies and procedures that flow from it. Our approach to training is engaging, interactive, and inclusive of knowledge tests and certifications. Sage also periodically reviews and updates its training programs to reflect developments in standards or understandings related to our comprehensive Compliance Program.
In addition to formal trainings, Sage encourages ongoing communication across all levels of our Company. Our People are encouraged to advance our culture of learning by proactively asking questions, seeking guidance, and making recommendations for improvements to business processes, training, and resources that support Our Values Code and the work we do. Our People have direct access to the Legal Department and Compliance Officers, and may communicate questions or concerns using our AdviceLine resources identified at www.sagerxadvice.com, which include options for anonymity where permitted by law.
Monitoring & Auditing
Sage’s Compliance Program regularly monitors and audits business activities to assess compliance with Our Values Code and the policies and procedures that flow from it. Through these monitoring and auditing activities, the Compliance Program can identify potential or existing problems or areas of concern and take corrective action in an effort to prevent the recurrence of non-compliance as needed. The nature and extent of our monitoring and auditing varies due to a variety of factors, including the learnings from our Risk Assessment.
Reward & Remediation
Our Compliance Program is committed to a framework of personal, focused, and sustained recognition to encourage Sageans who carry out their responsibilities as contemplated in Our Values Code. This framework also includes features to remediate missteps and poor choices. All reports of alleged violations are investigated. We conduct fair and diligent investigation of matters that are brought to the company’s attention and seek to ensure consistent application of our standards.
In collaboration with our Leadership Team and under the supervision of the Board of Directors, our Compliance Program imposes remedial and disciplinary measures for violations. Such measures are determined in Sage’s sole discretion and may include counseling, re-training, oral or written reprimands, warnings, probation, or suspension with or without pay, demotions, reductions in salary, termination of employment or service, and restitution, among other measures.
Annual Declaration: May 2023
To obtain a copy of this declaration and certification please email firstname.lastname@example.org.
Last update: May 2023