Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 92

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 92
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 faces an inherent risk of product liability lawsuits related to the sale of its products to, use of its products by, and testing of any product candidate in, seriously ill patients. For example, product liability claims might be brought against Cara by consumers, healthcare providers or others using, administering or selling its products. Cara may be sued if any product it develops allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. If Cara cannot successfully defend itself against these claims, Cara will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

| ● | loss of revenue from decreased demand for Cara’s products and/or any potential product candidate; |

| ● | impairment of Cara’s business reputation or financial stability; |

| ● | costs of related litigation; |

| ● | substantial monetary awards to patients or other claimants; |

| ● | diversion of management attention and scientific resources from Cara’s business operations; |

| ● | withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs; |

| ● | the inability to successfully commercialize Cara’s products and/or any potential product candidate; |

| ● | significant negative media attention; |

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| ● | initiation of investigations by regulators or increased regulatory scrutiny; |

| ● | product recalls, withdrawals or labeling, marketing or promotional restrictions; and |

| ● | the inability to commercialize any potential product candidate. |

Should Cara resume development of its product candidate or any future product candidate, for any product candidate that is approved for commercial sale, Cara will be highly dependent upon healthcare provider and patient perceptions of Cara and the safety and quality of Cara’s products. Cara could be adversely affected if it is subject to negative publicity. Cara could also be adversely affected if any of its products or any similar products distributed by other companies prove to be, or are asserted to be, harmful to patients. Because of Cara’s dependence upon consumer perceptions, any adverse publicity associated with illness or other adverse effects resulting from patients’ use or misuse of Cara’s products or any similar products distributed by other companies could have a material adverse impact on Cara’s financial condition or results of operations. Cara has obtained limited product liability insurance coverage for its products and its clinical trials with a $15.0 million annual aggregate coverage limit in the United States and various other coverage