Based on internal assessments, completed October 5, 2022, Aytu BioPharma, Inc. is in all material
respects and to the best of its knowledge, in compliance with the Aytu BioPharma California
Comprehensive Compliance Program as well as requirements reflected and its good faith understanding
of the California Health and Safety Code 119400-119402 for the calendar year of January 1, 2023 –
December 31, 2023. In addition, Aytu will continue to monitor for violations or non-compliance, and if
such violations are identified, Aytu will investigate and respond promptly and in accordance with the
California Comprehensive Compliance Program.
A copy of this guide can be obtained by calling 1-855-Aytu Bio, ext.681.
As part of the Aytu BioPharma, Inc. commitment to compliance and the laws and regulations that govern
the pharmaceutical and device sales and marketing activities in the U.S., Aytu has developed the
California Comprehensive Compliance Program. The Aytu Compliance Program has been developed in
accordance to the regulations set forth in the California Health and Safety Code, Section 119400-119402,
“Compliance Program Guidance for Pharmaceutical Manufacturers” published by the U.S. Department
of Health and Human Services Office of Inspector General (OIG), “Code of Interactions with Healthcare
Professionals” published by the Pharmaceutical Research and Manufactures of America (PhRMA), and
the “Code of Ethics on Interactions with Health Care Professionals adopted by the Advanced Medical
Technology Association (AdvaMed).
The Aytu Compliance Program is not static and will continue to change in accordance with the law.
Furthermore, the OIG guidance states that the policies within each pharmaceutical company should be
tailored to the unique nature of the company itself. Therefore, the Aytu Compliance Program has been
tailored in accordance to its individual products both pharmaceutical and device. The compliance
standards for our pharmaceutical products will be in accordance to the standards stated within the
“PhRMA Code of Interactions with Healthcare Professionals” and our device products will be regulated
and trained based on the compliance standards stated within the “AdvaMed Code of Ethics on
Interactions with Healthcare Professionals.”
The Aytu California Compliance Program is part of our internal, company compliance program.
2. Compliance Officer
Our Compliance Officer acts as our Chief Financial Officer (CFO). As part of our on-going commitment
to compliance, our Compliance Officer has regular (quarterly) meetings with our Board members and
works to oversee the training and implementation of our compliance program.
3. Code of Business Conduct and Ethics
Our Code of Business Conduct and Ethics is distributed to all Aytu employees at the start of employment
with the company and when any changes take place. The Business Code of Conduct and Ethics is a
universal statement that explains our values, ethical principles and will help to guide day to day operation.
In addition to the Code of Business Conduct and Ethics and Aytu policies and procedures, each Aytu field
representative or any Aytu employee who has interactions with Health Care Professionals will receive an
additional Compliance Manual aligned to their product. The Device and Diagnostic Compliance Manual
will reflect policies set up within the AdvaMed code and the Pharmaceutical Compliance Manual will be
used for those responsible for sales and marketing as related to any Aytu Pharmaceutical drug product.
Under both the device and pharmaceutical compliance manuals, field-based employees’ may offer items
designed primarily for the education of patients or healthcare professional where permitted by law and as
long as the items are not of substantial value nor have value outside of his/her professional
responsibilities. These items may include educational DVDs, Anatomical DVDs, or USBs with
Aytu field employee interactions with healthcare and medical professionals must be focused on providing
scientific and educational information and supporting medical information. The information must be
accurate and not misleading, make claims about a product only when substantiated, reflect balance
between risks and benefits, and be consistent with all FDA requirements governing such communications.
Additionally, Aytu field employees or Aytu appointed speakers may speak on behalf of Aytu. The events
focus on educating and informing other healthcare professionals about the benefits, risks and appropriate
uses of Aytu products. During these events/discussions, Aytu may provide meals of modest value as
stated with the Aytu Compliance Manuals.
4. Training and Education
Aytu is committed to the continued growth and education of its employees and those working on behalf
of the company. All employees are trained annually on all compliance policies as it relates to the function
of their job and the laws that impact their daily interactions. These training will commence upon the onboarding
of each employee and will occur upon any additional changes. On-going training and
certification will be made available, and the Compliance Committee is responsible for completing ongoing
email and communication as reminders and continued education throughout the calendar year.
Training is reviewed, approved, and updated on an on-going basis to ensure that all information is clear
and consistent with all laws and regulations.
5. Communication – Hotline
Aytu encourages its employees to communicate openly with their direct supervisors or other appropriate
personnel about observed illegal or unethical behavior or when in doubt of the best action in a particular
situation. Any employee who suspects a violation of the Code of Ethics or any law or regulation, should
bring the matter to the attention of the Chair of the Audit Committee or Outside Counsel as soon as
possible. Aytu’s policy is to not allow retaliation for reports of misconduct by others made in good faith
by employees. Aytu employees are required to cooperate in all internal investigations of misconduct.
Also, Aytu employees may anonymously, submit a good-faith concern by phone at 1-844-Tell AYTU or
go to www.intouchwebsite.com/TellAytuBio and report an incident.
The Aytu Compliance Program includes ongoing monitoring and audits of all activities related to
interactions with healthcare and medical professionals of our employees. Primarily, our management
team is responsible for daily review and confirmation of compliance within their individual teams.
Through random audits and continued monitoring of resources used by our field associates and internal
employees, we are able to review and track issues that should be investigated. The frequency of the audits
varies specifically on changes in business practices and internal resources.
Aytu audits and resulting information will be followed up on with the individual field employee promptly
and violations will be addressed individually. Violations will be reviewed, and disciplinary action will be
assessed internally and be consisted with internal policy. Issues with non-compliance will be used to
further assess any additional information that should be added or updated in our compliance program and
will assist in evaluating needs for additional training and/or resources.
8. Maximum Annual Limits
As stated in the California Health and Safety Code, Section 119400-119402, Aytu has established
maximum annual limits for gifts, promotional materials, or items or activities that Aytu may provide to a
California Healthcare or Medical Professional. This limit is set to $2000 annually for educational items,
product literature, and related Aytu items and are in accordance with Aytu Compliance policy and state
and federal regulations. Aytu employees are prohibited to provide or offer gifts, entertainment or entry to
recreational events to any HCP or Health Care Organization employee. Aytu acknowledges that a
majority of health and medical professionals receive significantly less the $2000 maximum annual limit
stated within the Comprehensive Compliance Policy.
The maximum annual limit does not include drug samples, samples of medical devices intended for free
distribution to patients, as well as financial support for continuing medical education nor financial support
for health educational scholarships.
Aytu is committed to the on-going compliance of its employees and associates working on behalf of the
company. The California Comprehensive Compliance Program is part of our overall training program
which includes the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the
U.S. Department of Health and Human Services Office of Inspector General (OIG), “Code of Interactions
with Healthcare Professionals” published by the Pharmaceutical Research and Manufactures of America
(PhRMA), and the “Code of Ethics on Interactions with Health Care Professionals adopted by the
Advanced Medical Technology Association (AdvaMed) as well as our internal policies and procedures
which include but are not limited to the Aytu Device and Diagnostic Compliance Manual, the Aytu
Pharmaceuticals Compliance Manual and the Aytu Code of Business Conduct and Ethics.
All materials listed within this document can be obtained by calling 1-855-AYTU BIO, ext. 681.