Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 75

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 75
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, civil penalties, failure to grant approval to market any of our drug candidates, delays, suspensions
or withdrawals of approvals, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect
our business. In addition, we do not have control over the ability of our contract manufacturers to maintain adequate quality control,
quality assurance and qualified personnel. Failure by our contract manufacturers to comply with or maintain any of these standards could
adversely affect our ability to develop, obtain and maintain regulatory approval for or market any of our drug products and drug candidates.

If, for any reason, these third
parties are unable or unwilling to perform, we may not be able to terminate our agreements with them, and we may not be able to locate
alternative manufacturers or formulators or enter into favorable agreements with them, and we cannot be certain that any such third parties
will have the manufacturing capacity to meet future requirements. If these manufacturers or any alternate manufacturer of finished drug
product experiences any significant difficulties in its respective manufacturing processes for our API or finished products or should
cease doing business with us, we could experience significant interruptions in the supply of any of our drug candidates or may not be
able to create a supply of our drug candidates at all. Were we to encounter manufacturing issues, our ability to produce a sufficient
supply of any of our drug candidates might be negatively affected. Our inability to coordinate the efforts of our third-party manufacturing
partners, or the lack of capacity available at our third-party manufacturing partners, could impair our ability to supply any of our
drug candidates at required levels. Because of the significant regulatory requirements that we would need to satisfy in order to qualify
a new bulk or finished product manufacturer, if we face these or other difficulties with our current manufacturing partners, we could
experience significant interruptions in the supply of any of our drug candidates if we decided to transfer the manufacture of any of
our drug candidates to one or more alternative manufacturers in an effort to deal with the difficulties.

Any manufacturing problem or
the loss of a contract manufacturer could be disruptive to our operations and result in lost sales. Additionally, we rely on third parties
to supply the raw materials needed to manufacture our existing and potential products. Any business interruptions resulting from geopolitical
actions, including war and terrorism, adverse public health developments, or natural disasters including earthquakes, typhoons, floods
and fires, could affect our supply chain. Any reliance on suppliers may involve several risks, including a potential inability to obtain
critical materials and reduced control over