Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 254

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 254
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 in our clinical trials or for commercial product. In addition, we do not have the capability to manufacture any
of our branded drug products and candidates as a finished drug product for commercial distribution. As a result, we are and will be obligated
to rely on contract manufacturers.

The facilities used by our contract
manufacturers to manufacture our drug products and candidates must be approved by the FDA or comparable foreign regulatory authorities
pursuant to inspections that will be conducted after we submit an NDA or BLA to the FDA or their equivalents to other relevant regulatory
authorities. We will not control the manufacturing process of, and will be completely dependent on, our contract manufacturing partners
for compliance with cGMPs for manufacture of both active drug substances and finished drug products. These cGMP regulations cover all
aspects of the manufacturing, testing, quality control and record keeping relating to our drug candidates. If our contract manufacturers
do not successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others,
they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. If the FDA or a comparable foreign
regulatory authority does not approve these facilities for the manufacture of our drug candidates or if it withdraws any such approval
in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain
regulatory approval for or market our drug candidates, if approved.

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Our contract manufacturers are
subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs
and similar regulatory requirements. We do not have control over our contract manufacturers’ compliance with these regulations
and standards. Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed
on us, including fines, injunctions, 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