Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 80

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 80
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agent and its potential orphan use are disclosed publicly by the FDA. Orphan product designation does not convey any advantage in or
shorten the duration of regulatory review and approval process. In addition to the potential period of exclusivity, orphan designation
makes a company eligible for grant funding of up to $400,000 per year for four years to defray costs of clinical trial expenses, tax
credits for clinical research expenses and potential exemption from the FDA application user fee.

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If a product that has orphan
designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product
is entitled to orphan drug exclusivity, which means the FDA may not approve any other applications to market the same drug for the same
indication for seven years, except in limited circumstances, such as (i) the drug’s orphan designation is revoked; (ii) its marketing
approval is withdrawn; (iii) the orphan exclusivity holder consents to the approval of another applicant’s product; (iv) the orphan
exclusivity holder is unable to assure the availability of a sufficient quantity of drug; or (v) a showing of clinical superiority to
the product with orphan exclusivity by a competitor product. If a drug designated as an orphan product receives marketing approval for
an indication broader than what is designated, it may not be entitled to orphan drug exclusivity. There can be no assurance that we will
receive orphan drug designation for any of our drug candidates in the indications for which we think they might qualify, if we elect
to seek such applications.

Although we may pursue expedited regulatory
approval pathways for a drug candidate, it may not qualify for expedited development or, if it does qualify for expedited development,
it may not actually lead to a faster development or regulatory review or approval process.

Although we believe there may
be an opportunity to accelerate the development of certain of our drug candidates through one or more of the FDA’s expedited programs,
such as fast track, breakthrough therapy, accelerated approval or priority review, we cannot be assured that any of our drug candidates
will qualify for such programs.

For example, a drug may be eligible
for designation as a breakthrough therapy if the drug is intended, alone or in combination with one or more other drugs, to treat a serious
or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over
existing therapies on one or more clinically significant endpoints. Although breakthrough designation or access to any other expedited
program