Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 72

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1A
Chunk 72
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 by the FDA and other federal and state enforcement agencies, including the Department of Justice. Violation of the FDCA and other statutes, including the False Claims Act, and equivalent legislation in other countries relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal and state and other countries’ health care fraud and abuse laws and state consumer protection laws. Even if it is later determined we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions and have to divert significant management resources from other matters. 

In addition, later discovery of previously unknown problems with our medicines, manufacturers, or manufacturing processes, or failure to comply with regulatory requirements, may yield various negative consequences, including: 

•restrictions on such medicines, manufacturers or manufacturing processes; 

•restrictions on the labeling or marketing of a medicine; 

•restrictions on the distribution or use of a medicine; 

•requirements to conduct post-marketing clinical trials; 

•receipt of warning or untitled letters; 

•withdrawal of the medicines from the market; 

•refusal to approve pending applications or supplements to approved applications that we submit; 

•recall of medicines; 

•fines, restitution or disgorgement of profits or revenue; 

•restrictions on future procurements with governmental authorities; 

•suspension or withdrawal of marketing approvals; 

•suspension of any ongoing clinical trials; 

•refusal to permit the import or export of our medicines; 

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•product seizure; and 

•injunctions or the imposition of civil or criminal penalties. 

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize any product candidates we may develop and adversely affect our business, financial condition, results of operations and prospects. 

Our relationships with healthcare providers, third-party payors and patients as well as our activities generally will be subject to a broad range of healthcare laws and regulations and any failure to comply with such laws and regulations could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. 

Certain federal and state healthcare laws and regulations pertaining to product promotion, fraud and abuse, privacy and price reporting and payment constrain the activities of pharmaceutical companies and their interactions with healthcare providers, third-party payors and patients. Those laws and regulations, including certain laws