Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 231

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 231
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 duration and specifics of FDA approval of the use of any product candidate, U. S. patents may be eligible for limited
patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years as
compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration
cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term
restoration period is generally one-half the time between the effective date of an IND, and the submission date of an NDA, plus the time
between the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible
for the extension and the application for extension must be made prior to expiration of the patent. The U. S. PTO, in consultation with
the FDA, reviews and approves the application for any patent term extension or restoration. In the future, Kadimastem intends to apply
for restorations of patent term for some of its currently owned patents to add patent life beyond their current expiration date, depending
on the expected length of clinical trials and other factors involved in the submission of the relevant NDA.

Market exclusivity
provisions under the FDCA can also delay the submission or the approval of certain applications. The FDCA provides a five-year period
of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical
entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety,
which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept
for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of
such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application
may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides
three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an approved NDA if new clinical investigations,
other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the