Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 246

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 246
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. Similar requirements exist in
many of these areas in other countries.

 39 

In addition, if any of our drug
candidates are approved for a particular indication, our product labeling, advertising and promotion would be subject to regulatory requirements
and continuing regulatory review. The FDA strictly regulates the promotional claims that may be made about prescription products. In
particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling.
If we receive marketing approval for our drug candidates, physicians may nevertheless legally prescribe our products to their patients
in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject
to significant liability and government fines. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion
of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant sanctions. The
federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several
companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees of permanent injunctions
under which specified promotional conduct is changed or curtailed.

If we or a regulatory agency
discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, problems with the
facility where the product is manufactured, or we or our manufacturers fail to comply with applicable regulatory requirements, we may
be subject to the following administrative or judicial sanctions:

    ●
    restrictions on the marketing or manufacturing of the product, withdrawal
    of the product from the market, or voluntary or mandatory product recalls; 

    ●
    issuance of warning letters or untitled letters; 

    ●
    clinical holds; 

    ●
    injunctions or the imposition of civil or criminal penalties or monetary
    fines; 

    ●
    suspension or withdrawal of regulatory approval; 

    ●
    suspension of any ongoing clinical trials; 

    ●
    refusal to approve pending applications or supplements to approved
    applications filed by us, or suspension or revocation of product license approvals; 

    ●
    suspension or imposition of restrictions on operations, including costly
    new manufacturing requirements; or 

    ●
    product seizure or detention or refusal to permit the import or export
    of product. 

The occurrence of any event or
penalty described above may inhibit our ability to commercialize