Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 253

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 253
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 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 drug candidates, which would have a material adverse
effect on our business.

We are and will be completely dependent on
third parties to manufacture our branded drug products and drug candidates, and our commercialization of our drug candidates could be
halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign
regulatory authorities, fail to provide us with sufficient quantities of our drug candidates or fail to do so at acceptable quality levels
or prices. 

We do not currently have, nor
do we plan to acquire, the capability or infrastructure to manufacture the active pharmaceutical ingredient (“API”) in our
drug candidates for use