Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 143

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 143
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. Efforts to ensure that its business arrangements comply with applicable healthcare laws and regulations, as well as responding to possible investigations by government authorities, can be time- and resource -consumingand can divert a company’s attention from the business. Healthcare legislative and regulatory reform measures may have a material adverse effect on its business and results of operations. NLS’s industry is highly regulated and changes in law may adversely impact its business, operations, or financial results. The PPACA was a sweeping measure intended to, among other things, expand healthcare coverage within the United States, primarily through the imposition of health insurance mandates on employers and individuals and expansion of the Medicaid program. NLS anticipate that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and an additional downward pressure on the reimbursement its customers may receive for its products. Further, there have been, and there may continue to be, judicial and Congressional challenges to certain aspects of the PPACA. For example, the U.S. Tax Cuts and Jobs Act of 2017, or TCJA, includes a provision repealing the tax -basedshared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent it from being able to generate revenue, attain profitability or commercialize its products. In addition, the delivery of healthcare in the European Union, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever -increasingEU and national regulatory burdens on 50 those wishing to develop and market products, this could prevent or delay marketing approval of its product candidates, restrict or regulate post -approvalactivities and affect its ability to commercialize any products for which NLS obtains marketing approval. NLS is currently unable to predict what additional legislation or regulation, if any, relating to the healthcare industry may be enacted in the future or