Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 43

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 43
---
. The FDA requires clinical trials to be conducted in accordance with good clinical practices, including for
conducting, recording and reporting the results of preclinical studies and clinical trials to assure that data and reported results are
credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected. Our reliance on
third parties that we do not control does not relieve us of these responsibilities and requirements. Any such event could have a material
adverse effect on our business, financial condition, results of operations and/or prospects.

28

Because
we rely on third party manufacturing and supply partners, our supply of research and development, and preclinical and clinical development
materials, may become limited or interrupted or may not be of satisfactory quantity or quality.

We
rely on third party supply and manufacturing partners to supply the materials and components for, and manufacture, our research and development,
preclinical and clinical trial drug supplies. We do not own manufacturing facilities or supply sources for such components and materials.
There can be no assurance that our supply of research and development, preclinical and clinical development drugs and other materials
will not be limited, interrupted, restricted in certain geographic regions or of satisfactory quality or continue to be available at
acceptable prices. In particular, any replacement of any drug product formulation manufacturer we may use could require significant effort
and expertise in the event there are a limited number of qualified replacements for a particular product candidate.

The
manufacturing process for a product candidate is subject to FDA and foreign regulatory authority review. Suppliers and manufacturers
must meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities
in order to comply with regulatory standards, such as cGMP. In the event that any of our suppliers or manufacturers fail to comply with
such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or
other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which
we currently do not have the capabilities or resources, or enter into an agreement with another third party, which we may not be able
to do on reasonable terms, if at all. In some cases, the technical skills or technology required to manufacture our product candidates
may be unique or proprietary to the original manufacturer, and we may have difficulty, or there may be contractual restrictions prohibiting
us from, transferring such skills or technology to another third party and a feasible alternative may not exist. These factors would
increase our reliance