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As an organization committed to improving the lives of patients with food allergies, we hold ourselves to the highest ethical standards.
Every decision and action taken at Aimmune is informed by our values. An unwavering commitment to compliance guides our interactions with patients, physicians, and peers in professional and personal environments.
We’re inspired and humbled by the patients, families, and physicians who are managing the life-threatening risks associated with food allergies. Every day, we work hard toward the goal of developing therapies that enable people with peanut and other food allergies and their families to live their lives with confidence.
Comprehensive Compliance Program
Aimmune Therapeutics, Inc. and its subsidiaries (“Aimmune” or “Company”) are committed to ensuring that all business practices are conducted in an ethical and transparent manner and in compliance with all applicable laws, including the California Health and Safety Code §119400-119402 (the “California Code”). The California Code requires pharmaceutical companies to adopt a Comprehensive Compliance Program that is in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the U.S. Department of Health and Human Services Office of Inspector General in April 2003 (OIG Guidance).
Aimmune has developed a Comprehensive Compliance Program in accordance with the OIG Guidance. As part of this Comprehensive Compliance Program, Aimmune has developed policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code). Aimmune is committed to developing and providing effective compliance training for all of its employees on these policies as well as pertinent federal and state standards. Aimmune periodically conducts internal auditing and monitoring to evaluate compliance with Company policies and procedures.
Aimmune’s Comprehensive Compliance Program includes a corporate Code of Conduct that all employees must read, acknowledge understanding of, and certify to. Aimmune has also established internal lines of communication and requires all employees to report instances of noncompliance with the Code of Conduct or Aimmune policies. Aimmune provides a Compliance Hotline that allows for anonymous reporting of compliance violations (1 (844) 255-1758 or www.aimmune.ethicspoint.com).
Annual Spending Limit
The California Code also requires pharmaceutical and medical device companies to adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the company may give or otherwise provide to an individual medical or healthcare professional (HCP) in accordance with the OIG Guidance and PhRMA Code.As part of Aimmune’s Comprehensive Compliance Program, Aimmune prohibits the giving of gifts to HCPs, including items for the personal benefit of HCPs or their family members, cash gifts or cash equivalents, and non-educational items. Aimmune has established an annual aggregate dollar limit of $2,000.00 for promotional materials or items or activities that the Company may give or otherwise provide to an individual HCP in accordance with the PhRMA Code and OIG Guidance. This limit may be revised from time to time. This dollar limit is a maximum only and does not necessarily represent a typical, average, usual, or customary amount. This dollar limit does not include the following types of expenditures:
Office Dosing Kits given to physicians and HCPs intended for free distribution to patients;
Financial support for continuing medical education forums;
Financial support for health educational scholarships; and
Payments made for legitimate professional services provided by an HCP or medical professional, including, but not limited to, consulting.
To the best of its knowledge and based on a good faith understanding of the requirements of the California Code, Aimmune declares that it is in compliance with its Comprehensive Compliance Program and the California Code.