Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 231

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 231
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 adverse actions by other state boards of pharmacy. FDA inspection of a facility to determine compliance with the FDCA,
if not successful, may result in the loss of FDCA exemptions provided under Sections 503A and 503B, warning letters, injunctions, prosecution,
fines and loss of required government licenses, certifications and approvals, any of which could involve significant costs and could
cause us to be unable to realize the expected benefits of these pharmacies’ operations. Additionally, the permanent injunction
entered on July 22, 2019, by the U.S. District Court of the Central District of California (the “Court”) in the Allergan
litigation (also referenced in Item. 3 Legal Proceedings), enjoins the Company from engaging in activities that are inconsistent with
current FDA guidelines for 503A and 503B operations.

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If we market any of our drug candidates in
a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil
or criminal penalties. 

The FDA enforces laws and regulations
which require that the promotion of pharmaceutical products be consistent with the approved prescribing information. While physicians
may prescribe an approved product for a so-called “off label” use, it is unlawful for a pharmaceutical company to promote
its products in a manner that is inconsistent with its approved label, and any company which engages in such conduct can subject that
company to significant liability. Similarly, industry codes in the EU and other foreign jurisdictions prohibit companies from engaging
in off-label promotion, and regulatory agencies in various countries enforce violations of the code with civil penalties. While we intend
to ensure that our promotional materials are consistent with our label, regulatory agencies may disagree with our assessment and may
issue untitled letters, warning letters or may institute other civil or criminal enforcement proceedings. In addition to FDA restrictions
on marketing of pharmaceutical products, several other types of state and federal healthcare fraud and abuse laws have been applied in
recent years to restrict certain marketing practices in the pharmaceutical industry. These laws include the U.S. Anti-Kickback Statute,
U.S. False Claims Act and similar state laws. Because of the breadth of these laws and the narrowness of the safe harbors, it is possible
that some of our business activities could be subject to challenge under one or more of these laws.

Our sales depend on coverage and reimbursement
from government and commercial third-party payors, and pricing and reimbursement pressures have affected, and are likely