Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 44

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 44
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 on such manufacturer or require us to obtain a license from such manufacturer in order to have another third party
manufacture our product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the
new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines.
The delays associated with the verification of a new manufacturer could negatively affect our ability to develop product candidates in
a timely manner or within budget.

We
expect to continue to rely on third party manufacturers if we receive regulatory approval for any product candidate. To the extent that
we have existing or future manufacturing arrangements with third parties, we will depend on these third parties to perform their obligations
in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance.
If we are unable to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable terms,
we may not be able to fully develop and commercialize our product candidates. Our or a third party’s failure to execute on our
manufacturing requirements could adversely affect our business in a number of ways, including:

    ●
    an
    inability to initiate or continue clinical trials of product candidates under development;

    ●
    delay
    in submitting regulatory applications, or receiving regulatory approvals, for product candidates;

    ●
    loss
    of the cooperation of a collaborator;

    ●
    subjecting
    our product candidates to additional inspections by regulatory authorities;

    ●
    requirements
    to cease distribution or to recall batches of our product candidates; and

    ●
    in
    the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.

We
may be unsuccessful in engaging in strategic transactions which could adversely affect our ability to develop and commercialize product
candidates, impact our cash position, increase our expense and present significant distractions to our management.

From
time to time, we may consider strategic transactions, such as collaborations, acquisitions of companies, asset purchases and out- or
in- licensing of product candidates or technologies. In particular, we will evaluate and, if strategically attractive, seek to enter
into additional collaborations, including with major biotechnology or pharmaceutical companies to complete development and marketing
of our product candidates, if approved. The competition for collaborators is intense, and the negotiation process is time-consuming and
complex. Any proposed collaboration may be on terms that are not optimal for us, and we may not be able