Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 235

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 235
---
 the federal income tax reform legislation previously passed by Congress and signed by President Trump on December 22, 2017,
that eliminated the individual mandate portion of the PPACA. The case, Texas, et al, v. United States of America, et al., (N. D. Texas),
is an outlier, but in 2019, the Fifth Circuit Court of Appeals subsequently upheld the lower court decision which was then appealed to
the United States Supreme Court. Further, in June 2021, the U. S. Supreme Court dismissed a lawsuit challenging the constitutionality
of the ACA after finding that the plaintiffs do not have standing to bring the litigation. Litigation and legislation over the ACA are
likely to continue, with unpredictable and uncertain results. Given these changes and other statements of political leaders, we cannot
predict the ultimate impact on the ACA and the subsequent effect on the pharmaceutical industry at this time. In November 2024,
Donald Trump was elected President and the Republican Party obtained control of the Senate. It is possible that additional executive
and regulatory initiatives, as well as legislation, will be pursued to enhance or reform ACA. We are not able to state with certainty
what the impact of potential legislation will be on Kadimastem’s business.

In addition, in
some non-U. S. jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements
governing drug pricing vary widely from country to country. For example, the EU provides options for its member states to restrict the
range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal
products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct
or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that
any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing
arrangements for other product candidate. Historically, products launched in the EU do not follow price structures of the United States
and generally tend to be significantly lower.

Healthcare Fraud
and Abuse Laws

In the U. S., the
research, development, testing, manufacturing, handling, storage, distribution, sale and promotion of drug products and medical devices
are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including the Centers for
Medicare & Medicaid Services, other