Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 78

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 78
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 or other government or regulatory authorities to temporarily or permanently shut down due to violations of cGMP requirements
    or other applicable requirements, or cross-contaminations of drug candidates in the manufacturing process; 

    ●
    any changes to our manufacturing process that may be necessary or desired;

    ●
    subjects choosing an alternative treatment for the indications for
    which we are developing our drug candidates, or participating in competing clinical studies; 

    ●
    subjects experiencing severe or unexpected drug-related adverse effects;

    ●
    reports from clinical testing on similar technologies and products
    raising safety and/or efficacy concerns; 

    ●
    third-party clinical investigators losing their license or permits
    necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or employing methods consistent
    with the clinical trial protocol, cGMP requirements, or other third parties not performing data collection and analysis in a timely
    or accurate manner; 

    ●
    inspections of clinical study sites by the FDA, comparable foreign
    regulatory authorities, or IRBs finding regulatory violations that require us to undertake corrective action, result in suspension
    or termination of one or more sites or the imposition of a clinical hold on the entire study, or that prohibit us from using some
    or all of the data in support of our marketing applications; 

 46 

    ●
    third-party contractors becoming debarred or suspended or otherwise
    penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may
    need to find a substitute contractor, and we may not be able to use some or any of the data produced by such contractors in support
    of our marketing applications; 

    ●
    one or more IRBs refusing to approve, suspending or terminating the
    study at an investigational site, precluding enrollment of additional subjects, or withdrawing its approval of the trial; reaching
    agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation
    and may vary significantly among different CROs and trial sites; 

    ●
    deviations of the clinical sites from trial protocols or dropping out
    of a trial; 

    ●
    adding new clinical trial sites; 

    ●
    the inability of the CRO to execute any clinical trials for any reason;
    and 

    ●
    government or regulatory delays or “clinical holds” requiring
    suspension or