Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 99

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 99
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 HHS selected fifteen additional drugs covered under Part D
for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug
Price Negotiation Program. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical
industry. Further in response to the Biden administration’s October 2022 executive order, on February 14, 2023, HHS released
a report outlining three new models for testing by the Centers for Medicare & Medicare Services, or CMS, Innovation Center which
will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It is unclear whether
the models will be utilized in any health reform measures in the future.

Further, on December 7,
2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under
the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency
Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor
an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain
if that will continue under the new framework. Individual states in the United States have also become increasingly active in passing
legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and in some cases,
designed to encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA approved Florida’s
Section 804 Importation Program (SIP) proposal to import certain drugs from Canada for specific state healthcare programs. It is
unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges
in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA. Any such
approved importation plans, when implemented, may result in lower drug prices for products covered by those programs.

In the future, there will
likely continue to be proposals relating to the reform of the U. S. healthcare system, some of which could further limit coverage
and reimbursement of drug products, including combined company’s product candidates.