Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 144

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 144
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 approval of the product for use in adults,
or full or partial waivers from the pediatric data requirements. The FDA must send a non-compliance letter to any sponsor that fails to
submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation. Unless otherwise
required by regulation, the pediatric data requirements do not apply to products with orphan designation.

Pediatric Exclusivity

Pediatric exclusivity is a type of non-patent
marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing
protection to the term of any existing regulatory exclusivity, including orphan exclusivity. This six-month exclusivity may be granted
if a NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show
the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s
request, the additional protection is granted.

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U.S. Patent Term Restoration and Extension

In the United States, a patent claiming a new
biologic product, its method of use or its method of manufacture may be eligible for a limited patent term extension under the Hatch-Waxman
Amendments, which permits a patent extension of up to five years for patent term lost during product development and FDA regulatory
review. Assuming grant of the patent for which the extension is sought, the restoration period for a patent covering a product is
typically one-half the time between the effective date of the IND and the submission date of the NDA, plus the time between the submission
date of the NDA and the ultimate approval date, except that the review period is reduced by any time during which the applicant failed
to exercise due diligence. Patent term restoration cannot be used to extend the remaining term of a patent past a total of 14 years
from the product’s approval date in the United States. Only one patent applicable to an approved product is eligible for the extension,
and the application for the extension must be submitted prior to the expiration of the patent for which extension is sought. A patent
that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. The USPTO reviews
and approves the application for any patent term extension in consultation with the FDA.

Regulation and Procedures Governing Approval of Medicinal Products in Europe

In order to