Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 173

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 173
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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 51 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 what effect recently enacted federal legislation or any such additional legislation or regulation would have on its business. The pendency or approval of such proposals or reforms could result in a decrease in the price of its NLS Common Shares or Warrants or limit its ability to raise capital or to enter into collaboration agreements for the further development and potential commercialization of its products. The use of any of NLS’s product candidates could result in product liability or similar claims that could be expensive, damage its reputation and harm its business. NLS’s business exposes it to an inherent risk of potential product liability or similar claims. The pharmaceutical industry has historically been litigious, and NLS face financial exposure to product liability or similar claims if the use of any of its products were to cause or contribute to injury or death. There is also the possibility that defects in the design or manufacture of any of its products might necessitate a product recall. Although NLS plans to maintain product liability insurance, the coverage limits of these policies may not be adequate to cover future claims. In the future, NLS may be unable to maintain product liability insurance on acceptable terms or at reasonable costs and such insurance may not provide it with adequate coverage against potential liabilities. A product liability claim, regardless of merit or ultimate outcome, or any product recall could result in substantial costs to us,