Compliance

Introduction:

Afaxys® is committed to compliance with all applicable laws, regulations, industry codes such as the PhRMA Code on Interaction with Healthcare Professionals (“PhRMA Code”), and guidance provided by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) that pertain to the sale, marketing and distribution of pharmaceutical products, and in certain respects, the operation of group purchasing organizations (“GPO”). In addition, Afaxys is committed to compliance with the laws, regulations and industry standards governing the reporting of process and reimbursement information for government-reimbursed products.

Based on the applicable laws, regulations, PhRMA Code and OIG guidance, Afaxys has implemented a corporate wide, comprehensive compliance program. Policies have been developed to address these laws, regulations, codes and guidance. All employees and agents of Afaxys receive training on these policies at hire and on an annual basis.

Elements of the Afaxys Corporate Compliance Program

1. Code of Conduct and Written Policies and Procedures

The Afaxys Code of Conduct serves as the basis for the company’s compliance program. The Code provides general guidance regarding appropriate conduct of business activities. The Policy and Procedure Manual provides specific guidance on business activities including interactions with healthcare professionals and customers.

2. Chief Compliance Officer and Compliance Committee

Afaxys has appointed a Chief Compliance Officer (CCO) who is responsible for overseeing the Afaxys compliance program. The CCO chairs the compliance committee and provides periodic updates on the compliance program to the Afaxys Board of Directors.

In addition, Afaxys has established a compliance committee which is chaired by the CCO and is comprised of members of the Afaxys executive team. The committee meets quarterly to review the activities of corporate compliance (including training, audits or investigations), review new or revise existing policies and procedures, and review any compliance-related questions or complaints.

3. Training and Education

Afaxys has distributed the Code of Conduct, Compliance Manual and Manual of Policies and Procedures to all employees and agents. Training on the compliance program is provided to all new employees and agents and refreshed on a yearly basis for existing employees/agents.

4. Effective Lines of Communication

Afaxys has a written open door policy to encourage the open and honest discussion between employees, agents and supervisors in all departments of the company. Afaxys has a compliance hotline and website for reporting anonymously or confidentially any concerns about the conduct of business activities.

5. Auditing and Monitoring

The compliance committee works to continuously monitor Afaxys business activities to ensure the company’s compliance with the policies as well as applicable laws and regulations. The results of audits are reported to the executive team and the Board of Directors.

6. Enforcing Standards Through Disciplinary Guidelines

The company Code of Conduct, Compliance Manual and manual of Policies and Procedures include a clear description of the Afaxys disciplinary standards.

7. Non-Compliance and Corrective Action

Under the Afaxys compliance policies, all reported allegations of non-compliance are investigated by the Chief Compliance Officer and reviewed by the compliance committee. Corrective actions are recommended, reviewed and approved by the compliance committee. Any corrective actions will be implemented to ensure the incident is resolved in a timely fashion and to prevent a reoccurrence of the event.

Disclosures

1. Federal and State Laws

Afaxys complies with all federal and state laws and regulations including recording and reporting payments under the Physician Payment Sunshine Act and similar state statutes.

2. Aggregate Spending Limit

Pursuant to Chapter 8, Section 119402(d) of Part 15 of Division 104 of the California Health and Safety Code, Afaxys has set an annual dollar limit on gifts (defined as anything of value, including meals), promotional materials, or items or activities that Afaxys employees may give or otherwise provide to an individual healthcare provider. Afaxys has set that annual spending limit at $1,500 (May 31, 2020).

3. Annual Declaration for California

Based on Afaxys’ good faith understanding of the requirements of Chapter 8, Section 119402(d) of Part 15 of Division 104 of the California Health and Safety Code, and to the best of its knowledge, Afaxys is in compliance in all material respects with this Chapter. (May 31, 2020)

To report SUSPECTED ADVERSE REACTIONS, contact Afaxys at 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.