Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 97

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 97
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its product candidates and to produce, market and distributecombined company’sproducts after clearance or approval
is obtained.

From time to time, legislation
is drafted and introduced in United States Congress, or Congress, that could significantly change the statutory provisions governing
the regulatory clearance or approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations
and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect combined company’s business and
products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review
times of the combined company’s product candidates. NLS and Kadimastem cannot determine what effect changes in regulations, statutes,
legal interpretation or policies, when and if promulgated, enacted or adopted may have on the combined company’s business in the
future. Such changes could, among other things, require:

  changes to manufacturing methods;  
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  change in protocol design;  
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  additional treatment arm (control);  

  recall, replacement, or discontinuance of one or more of the  

  additional recordkeeping.  

In addition, in the
United States, there have been a number of legislative and regulatory proposals to change the health care system in ways that
could affect the combined company’s ability to sell the combined company’s products profitably. The pharmaceutical
industry in the United States, as an example, has been affected by the passage of the Patient Protection and Affordable Care
Act, or Affordable Care Act, which, among other things, imposed new fees on entities that manufacture or import certain branded
prescription drugs and expanded pharmaceutical manufacturer obligations to provide discounts and rebates to certain government
programs. There have been executive, judicial and Congressional challenges to certain aspects of the Affordable Care Act. For
example, on June 17, 2021, the U. S. Supreme Court dismissed a challenge on procedural grounds that argued the Affordable
Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. On
August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other
things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through
plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by
sign