Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 109

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 109
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 be required to limit commercialization of its product candidates. NLS 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, NLS 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 it 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 NLS cannot successfully defend itself against any such claims, NLS may incur substantial liabilities, even if NLS has product liability or such other applicable insurance policies in effect. NLS may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms. Excessive insurance costs 30 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, NLS 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 NLS’s product candidates; •termination of clinical trial sites or entire trial programs; •injury to NLS’s reputation and negative media attention; •product recalls or increased warnings on product labels; •withdrawal of clinical trial participants; •costs to defend the related litigation; •diversion of NLS’s management and 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 our product candidates, if approved. NLS may fail to comply with data protection legislation or appropriate practices. NLS is subject to laws regarding the protection, privacy and security of personal information, such as the Swiss Federal Act on Data Protection (Bundesgesetz über den Datenschutz of 2020, as amended), or the Federal Data Protection Act, and Regulation (EU) 2016/679 (General Data Protection Regulation, or GDPR), and expects the regulatory landscape to continue to evolve. Data protection laws may impose restrictions on data practices which may necessitate changes to NLS’s operations, impact operational efficiency, prevent the application of certain marketing and sales initiatives