Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 141

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 141
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 route of administration must submit a Pediatric Study Plan (“PSP”) that contains
an outline of the proposed pediatric study or studies the applicant plans to conduct, including study objectives and design, any deferral
or waiver requests and other information required by regulation. The sponsor and the FDA must reach agreement on the PSP. The FDA or
the applicant may request an amendment to the plan at any time.

The FDA may, on its own initiative or at the
request of the applicant, grant deferrals for submission of some or all pediatric data until after 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