Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 142

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 142
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 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 safety and efficacy of the product for each
proposed indication. Data should be generated to demonstrate that a drug substance and a drug product can be manufactured and controlled
according to the pre-specified quality standards. The data relating to quality, preclinical testing and clinical trials should be submitted
to the relevant competent authorities in a marketing authorization application (“MAA”) for regulatory review in order to
determine whether a marketing authorization can be granted. Even if a marketing authorization has been granted, there is a need to obtain
a pricing and reimbursement decision before a new medicinal product can be marketed and sold in the EU and/or the UK (as applicable).

Clinical Trial Approval

Pursuant to the currently applicable Regulation
(EU) No 536/2014 (CTR) and Directive 2005/28/EC on GCP, an applicant must obtain approval from the national competent authority of an
EU member state in which the clinical trial is to be conducted, or in multiple member states if the clinical trial is to be conducted
in a number of member states. Furthermore, the applicant can only start a clinical trial at a specific site after a research ethics committee
has issued a favorable opinion. The clinical trial