California Compliance Declaration
- Comprehensive Compliance Program Statement
This statement is provided pursuant to California Health & Safety Code §§ 119400–119402, which requires certain pharmaceutical companies doing business in California to: (i) adopt a comprehensive compliance program consistent with the April 2003 U.S. Department of Health and Human Services Office of Inspector General (“OIG”) Compliance Program Guidance for Pharmaceutical Manufacturers; (ii) include policies for compliance with the PhRMA Code on Interactions with Health Care Professionals; (iii) establish a specific annual aggregate dollar limit on certain items or activities provided to California medical or health professionals; and (iv) provide an annual written declaration of compliance.
- Denali’s Comprehensive Compliance Program
Denali Therapeutics Inc. (“Denali”) has established a Comprehensive Compliance Program designed to promote ethical conduct and compliance with applicable federal and state laws, regulations, and industry codes governing interactions with healthcare professionals and other stakeholders. Denali’s Comprehensive Compliance Program is designed to be consistent with the OIG’s pharmaceutical manufacturer compliance guidance and includes policies intended to foster compliance with the PhRMA Code, as each may be updated from time to time. Denali will make conforming updates within the timeframes required by California law.
Denali’s Comprehensive Compliance Program includes, among other elements:
- Written standards and policies addressing compliance risks relevant to Denali’s operations
- Designated compliance leadership with responsibility for oversight of the compliance program
- Training and education for relevant personnel
- Open lines of communication for questions and reporting concerns, including anonymous reporting
- Monitoring and auditing processes designed to assess adherence and program effectiveness
- Investigation and corrective action processes and appropriate discipline for violations
- Annual Aggregate Dollar Limit
Denali has established a specific annual aggregate dollar limit of $2,000 on the value of certain gifts, promotional materials, or items or activities that Denali may give or otherwise provide to an individual California medical or health professional.
This $2,000 limit is a maximum annual cap, not a goal, average, or target. In many instances, Denali’s actual spend per medical or health professional will be substantially below this cap.
Consistent with California law, the annual limit does not include:
- Drug samples intended for free distribution to patients;
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships; and
- Payments at fair market value for legitimate professional services (e.g., consulting), including meals or expenses associated with providing those services, when provided consistent with OIG guidance and the PhRMA Code.
- Requests for Copies
To request a copy of Denali’s Comprehensive Compliance Program or Declaration of Compliance, call (650) 866-8548.
- Declaration of Compliance
Reporting Period: January 1, 2026 – December 31, 2026
Denali declares that, to the best of its knowledge and based on a good faith understanding of the statutory requirements, Denali has established a Comprehensive Compliance Program consistent with the requirements of California Health & Safety Code §§ 119400–119402, and that in all material respects it is in compliance with its Comprehensive Compliance Program.