A. General
This Comprehensive Compliance Program for Sales and Marketing Activities (the
“Compliance Program”) of Maxcure Pharmaceutical is a program to promote
compliance with applicable laws, rules, and regulations and to promote ethical and
responsible decision making in the sale and marketing of Maxcure Pharmaceutical’s pharmaceutical
products . Maxcure Pharmaceutical will review and update this Compliance Program from time to time as it
reasonably deems appropriate.
B. Compliance Officer and Compliance Committee
Maxcure Pharmaceutical has designated a Compliance Officer to ensure the integrity of and to implement
Maxcure Pharmaceutical’s Compliance Program. In addition, Maxcure Pharmaceutical has designated a Compliance Committee
consisting of senior management and other personnel to provide compliance oversight to
Maxcure Pharmaceutical and to support the Compliance Officer.
C. Written Standards of Conduct, Policies, and Procedures
Maxcure Pharmaceutical has developed written policies and procedures addressing compliance issues in
connection with its interactions with medical and other healthcare professionals and
related activities. These policies and procedures are designed to ensure compliance with
the recommendations set forth in the U.S. Department of Health and Human Services
“Compliance Program Guidance for Pharmaceutical Manufacturers”, Office of the Inspector
General, and in the Pharmaceutical Research and Manufacturers of America Code on
Interactions with Healthcare Professionals (commonly known as the “PhRMA Code”). The
Compliance Committee is responsible for approving such written policies and procedures
and will periodically review and revise certain policies and procedures as it deems
appropriate.
D. Training
Maxcure Pharmaceutical’s compliance policies and procedures are distributed to all employees. All Maxcure Pharmaceutical
personnel are required to participate in training relevant to their positions as a
condition of their employment and certify in writing as to their participation in such
training. All employees are required to undergo additional periodic training as deemed
necessary by the Compliance Committee.
E. Monitoring of Sales and Marketing Programs
From time to time, Maxcure Pharmaceutical will select certain sales and marketing programs to review in
order to confirm that the selected programs are being carried out in accordance with the
relevant Maxcure Pharmaceutical policies and procedures, as well as all applicable laws, regulations,
and rules. Each such review will be conducted by or under the supervision of the
Compliance Officer and will be documented and reported to the Compliance Committee.
F. Procedures for Reporting Violations
Maxcure Pharmaceutical employees are encouraged to report any known or suspected compliance violations
to their supervisor, to the Compliance Officer or to the Legal Department. Maxcure Pharmaceutical has
also established an Ethics Helpline that is available 24 hours a day, seven days a week
at (800) 826-6762. Employees may submit anonymous reports through the Ethics Helpline.
All reports will be documented and reported to the Compliance Committee.
G. Investigations, Corrective Actions and Disciplinary Policies
In the event that Maxcure Pharmaceutical becomes aware of any known or suspected compliance violation,
through either the routine monitoring of its sales and marketing programs or a reported
violation, designees of the Compliance Committee will investigate the circumstances
surrounding the known or suspected violation and will take appropriate corrective
action, which may involve disciplinary action, up to and including termination.
H. Annual Dollar Limit on Gifts or Incentives Provided to Medical or Health
Professionals in California
As required by, and in accordance with the definitions set forth in, California Health
and Safety Code §119402(d)(1), Maxcure Pharmaceutical has established an annual dollar limit on gifts,
promotional materials, or items or activities that Maxcure Pharmaceutical may give or otherwise provide
to an individual medical or health care professional in the state of California, subject
to the exclusions set forth in California Health and Safety Code §119402(d)(2)-(3).
I. Copies of Compliance Program and Annual Declaration
As part of Maxcure Pharmaceutical’s commitment to uphold the highest standards of integrity in the
conduct of its business, and in accordance with California Health and Safety Code
sections 119400 and 119402, based on Maxcure Pharmaceutical’s good faith knowledge, Maxcure Pharmaceutical believes that
it is in substantial compliance with its Compliance Program and the requirements set
forth in California Health and Safety Code sections 119400 and 119402.
This Declaration
is effective as of May 1, 2019 for the January 1, 2023 through December 31, 2023
declaration period.