Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 139

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 139
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 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 and result in increased regulatory and compliance costs. Also, compliance with data privacy laws has become more complex and compliance costs have increased significantly and may continue to do so. NLS may not be fully compliant with the Federal Data Protection Act or other applicable data protection legislation at all times. Failure to comply with data protection laws or laws related to use of personal data in marketing (such as laws concerning use of cookies and similar techniques) could subject NLS to potentially significant liability, including litigation, investigation, regulatory actions or other actions by local, cantonal or federal authorities, and may result in, among other consequences, penalties and fines (which may not be covered by NLS’s insurance policies or contractual protections and which may be significant, particularly if imposed under the GDPR), required remedial actions, as well as reputational harm, negative publicity and increased customer churn, any of which could have a material adverse effect on NLS’s business, revenues, earnings and cash flows. NLS Risks Related to the Regulatory Environment Obtaining approval of an NDA or an MAA even after clinical trials that are believed to be successful is an