Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 255

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 255
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 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 production costs, delivery schedules, reliability and quality. Any unanticipated disruption
to a future contract manufacturer caused by problems at suppliers could delay shipment of any of our drug candidates, increase our cost
of goods sold and result in lost sales.

We expect to rely on third parties to conduct
clinical trials for our drug candidates. If these third parties do not successfully carry out their contractual duties or meet expected
deadlines, we may not be able to obtain regulatory approval for or commercialize any of our drug candidates, and our business would be
substantially harmed. 

We expect to enter into agreements
with third-party CROs to conduct and manage our clinical