Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 208

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 208
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 policies, and it may be required to limit commercialization of its product candidates. Kadimastem is exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of pharmaceutical products. Currently, it has no products that have been approved for marketing or commercialization; however, the use of its product candidates in clinical trials, and the sale of these product candidates, if approved, in the future, may expose it to liability claims. Product liability claims may be brought against Kadimastem or its partners by participants enrolled in its clinical trials, patients, health care providers, pharmaceutical companies, its collaborators or others using, administering or selling any of its future approved products. If Kadimastem cannot successfully defend itself against any such claims, it may incur substantial liabilities, even if Kadimastem has product liability or such other applicable insurance policies in effect. Kadimastem may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms. Excessive insurance costs or uninsured claims would add to its future operating expenses and adversely affect its financial condition. As a result of such lawsuits and their potential results, it may be required to limit commercialization of its product candidates. Regardless of the merits or eventual outcome, liability claims may result in: •decreased demand for its drug substances and product candidates; •termination of clinical trial sites or entire trial programs; 87 •injury to its reputation and negative media attention; •product recalls or increased warnings on product labels; •withdrawal of clinical trial participants; •costs of to defend the related litigation; •diversion of management and its resources; •substantial monetary awards to, or costly settlements with, clinical trial participants, patients or other claimants; •higher insurance premiums; •loss of initiation of investigations by regulators or other authorities; and •the inability to successfully commercialize its drug substances and product candidates, if approved. Kadimastem’s inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products it develops or acquires. Kadimastem intends to obtain product liability insurance covering its clinical trials. Although Kadimastem will maintain such insurance, any claim that may be brought against Kadimastem could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by its insurance or that is in excess of the limits of Kadimast