Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 256

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 256
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 programs, including contracting with clinical sites to perform our clinical
studies. We plan to rely heavily on these parties for execution of clinical studies for our drug candidates and will control only certain
aspects of their activities. Nevertheless, we will be responsible for ensuring that each of our studies is conducted in accordance with
the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs and clinical sites will not relieve us
of our regulatory responsibilities. We and our CROs will be required to comply with cGCPs, which are regulations and guidelines enforced
by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable foreign regulatory authorities
for any products in clinical development. The FDA and its foreign equivalents enforce these cGCP regulations through periodic inspections
of trial sponsors, principal investigators and trial sites. If we or our CROs fail to comply with applicable cGCPs, the clinical data
generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to
perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA or
other regulatory authorities will determine that any of our clinical trials comply with cGCPs. In addition, our clinical trials must
be conducted with products produced under cGMP regulations and will require a large number of test subjects. Our failure or the failure
of our CROs or clinical sites to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory
approval process and could also subject us to enforcement action up to and including civil and criminal penalties.

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Although we intend to design
the clinical trials for our drug candidates in consultation with CROs, we expect that the CROs will manage all of the clinical trials
conducted at contracted clinical sites. As a result, many important aspects of our drug development programs would be outside of our
direct control. In addition, the CROs and clinical sites may not perform all of their obligations under arrangements with us or in compliance
with regulatory requirements. If the CROs or clinical sites do not perform clinical trials in a satisfactory manner, breach their obligations
to us or fail to comply with regulatory requirements, the development and commercialization of any of our drug candidates for the subject
indication may be delayed or our development program materially and irreversibly harmed. We cannot control the amount and timing of resources
these CROs and