2024 Statement regarding compliance with California Health & Safety Code §§ 119400-119402

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.

Iovance Biotherapeutics, Inc. (“Iovance”) has a Comprehensive Compliance Program (CCP) in accordance with the requirements of California Health & Safety Code §§ 119400-119402. Iovance has designed its CCP in accordance with the April 2003, publication “Compliance Program Guidance for Pharmaceutical Manufacturers,” which was developed by the United States Department of Health and Human Services Office of Inspector General. In its CCP, Iovance also includes policies for compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals. Iovance has also designed its CCP to address any issues raised in California Health & Safety Code §§ 119400-119402 that are unique to California.

As part of its ongoing commitment to operate in an ethical and compliant manner, Iovance continually (at least annually) assesses its CCP and makes changes as necessary to improve it. Additionally, Iovance has established an annual limit of $2000 for spending on promotional items and activities provided to a health care professional licensed in California. Such items generally are provided to physicians and certain other health care professionals in order to facilitate an educational or scientific discussion about the company’s products, the company’s research and development efforts, and other health care-related issues. Excluded from this limit are drug samples, patient educational materials, financial support for continuing medical education forums, financial support for health educational scholarships, and fair market value payments made for legitimate services provided by a health care medical professional to Iovance. This limit, which may be revised from time to time by Iovance in its sole discretion, applies to activities occurring from January 1, 2024 – December 31, 2024.

As of 05/23/2024, Iovance hereby declares, to the best of its knowledge, that it is in compliance with its CCP and the requirements of California Health & Safety Code §§ 119400-119402. In making this declaration of compliance, Iovance is asserting that its CCP consists of a Compliance Officer, policies, training, open lines of communication, auditing and monitoring and has processes in place to prevent and identify any potentials violations of the CCP and provides for any appropriate disciplinary and corrective actions.

To obtain a copy of this declaration of compliance and/or a description of Iovance CCP, please call 1-844-845-4682 or send an email to: