Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 73

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 73
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 Care Reform Law
on us at this time.

In addition, other legislative
changes have been proposed and adopted in the U.S. since the Health Care Reform Law was enacted. We expect that additional federal healthcare
reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare
products and services, and in turn could significantly reduce the projected value of certain development projects and reduce or eliminate
our profitability.

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Our drug candidates may face competition sooner
than expected. 

Our success will depend in part
on our ability to obtain and maintain patent protection for certain of our drug candidates and technologies and to prevent third parties
from infringing upon our proprietary rights. We must also operate without infringing upon patents and proprietary rights of others, including
by obtaining appropriate licenses to patents or other proprietary rights held by third parties, if necessary. However, the applications
we have filed or may file in the future may never yield patents that protect our inventions and intellectual property assets. Failure
to obtain patents that sufficiently cover our formulations and technologies would limit our protection against compounding pharmacies,
outsourcing facilities, generic drug manufacturers, pharmaceutical companies and other parties who may seek to copy our products, produce
products substantially similar to ours or use technologies substantially similar to those we own.

We also intend to seek data exclusivity
or market exclusivity for our drug candidates provided under the FDCA and similar laws in other countries. The FDCA provides three years
of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability
studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application,
for example, for new indications, dosages, or strengths of an existing drug. This three-year exclusivity covers only the conditions associated
with the new clinical investigations and does not prohibit the FDA from approving NDAs for drugs containing the original active agent.
Even if our drug candidates are considered to be reference products eligible for three years of exclusivity under the FDCA, another company
could market competing products if the FDA approves a full NDA for such product containing the sponsor’s own pre-clinical data
and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of the products. Moreover, an
amendment or repeal of the FDCA could result in a shorter exclusivity period for our