CALIFORNIA COMPLIANCE POLICY SUMMARY AND DECLARATION

 

It is the policy of EYENOVIA to comply with all applicable laws and regulations and industry standards, including the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” and the U.S. Department of Health and Human Services, Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers.”

EYENOVIA commits to operating ethically and declares that we have established a comprehensive compliance program. To the best of our knowledge and based on a good faith understanding of the statutory requirements of California Health and Safety Code §119400 – 119402, the EYENOVIA compliance program meets the requirements of establishing a comprehensive compliance program under the statute.

EYENOVIA has adopted a Code of Conduct, which serves as an affirmation of ethical principles that guide EYENOVIA’s business decisions and interactions. A copy of the Code of Conduct is available by clicking here. The Code of Conduct applies to all EYENOVIA employees and establishes expectations that every employee will act in accordance with applicable laws and Company policies.

EYENOVIA Personnel interact with Healthcare Professionals (HCPs) to provide them with information about EYENOVIA products, therapeutic areas in which EYENOVIA has an interest and other educational or scientific topics. EYENOVIA’s relationships with HCPs are intended to benefit patients and to enhance the practice of medicine. Informational presentations and discussions by EYENOVIA Personnel and others speaking on behalf of EYENOVIA provide valuable scientific and educational benefits.

In connection with such presentations or discussions, EYENOVIA may offer occasional meals and healthcare practice-related items in accordance with the PhRMA Code. Items intended to benefit patients are permissible, but may not cost more than $100, and may be offered only on an occasional basis. EYENOVIA has established a specific annual aggregate dollar limit of $2,000 per HCP in California with a $500 limit on promotional materials, patient education items, healthcare practice items, and activities in accordance with California Health & Safety Code §§119400-119402 and a $1,500 limit on meals.

You may contact EYENOVIA about this California Annual Declaration of Compliance or the EYENOVIA Code of Conduct by calling 1-833-393-6684 x9.

Date: April 1, 2024