Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 217

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 217
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Our
business exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic
treatments. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products,
such claims could result in an FDA investigation of the quality and effectiveness of our products, our manufacturing processes and facilities
or our marketing programs and potentially a recall of our products or more serious enforcement action, limitations on the approved indications
for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may
also result in decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s
time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price. We currently
have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels prior
to marketing any of our product candidates. Any insurance we have or may obtain may not provide sufficient coverage against potential
liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable
to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have a
material adverse effect on our business.

31

Our
employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including noncompliance
with regulatory standards and requirements.

We
are exposed to the risk that our employees, principal investigators, CROs and consultants may engage in fraud, other misconduct or illegal
activity. Misconduct by these parties could include intentional failures to comply with FDA regulations, provide accurate information
to the FDA, comply with manufacturing standards we may establish, comply with federal and state healthcare fraud and abuse laws and regulations,
report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business
arrangements in the healthcare industry are subject to extensive laws and regulations, kickbacks, self-dealing and other abusive practices.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission,
customer incentive programs and other business arrangements. While we make an effort to maintain strict work processes and oversight
of our employees, contractors and consultants, any misconduct could expose us to liability through the improper use of information obtained
in the course of clinical trials, which could result in regulatory sanctions and serious harm to