Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 135

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 135
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 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 market any medicinal product outside
of the United States, a company must also comply with numerous and varying regulatory requirements to generate relevant data for the
purpose of establishing its quality, safety and efficacy. There are specific rules governing, among other things, clinical trials, marketing
authorization, commercial sales and distribution of products. Regardless of the product approval status in the United States, an applicant
will need to obtain the necessary approvals granted by the comparable foreign regulatory authorities before it can commence clinical
trials or marketing of a medicinal product in those countries or jurisdictions.

The processes governing approval of medicinal
products in the EU and UK generally adopt a similar approach to that applied in the United States. They entail satisfactory completion
of preclinical studies and adequate and well-controlled clinical trials to establish the