Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 150

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 150
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ological products. Notwithstanding that there
is no wholesale recognition of EU pharmaceutical legislation under the TCA, and that EU marketing authorizations do not automatically
provide a valid basis for the commercialization of medicinal products in Great Britain from January 1, 2024, applicants will be able
to request the MHRA to recognize marketing authorizations granted in foreign jurisdictions (including the EU) under a new International
Recognition Procedure.

Patent Term Extensions in the EU and Other Jurisdictions

The EU also provides for patent term extension
through SPCs which aim to offset the loss of patent protection for pharmaceutical products arising from the lengthy testing and clinical
trials required to obtain an MA. The rules and requirements for obtaining a SPC are similar to those in the United States. An SPC may
extend the term of a basic patent for up to five years after its originally scheduled expiration date in order to provide up to a
maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains an MA for it to be placed on
the market. As mentioned above, in certain circumstances, these periods may be extended for six additional months if pediatric exclusivity
is obtained; and in the case of orphan medicinal products, a two-year extension of the orphan market exclusivity may be available. Although
SPCs are available throughout the EU, holders must apply the patent term extension on a country-by-country basis. Similar patent term
extension rights exist in certain other foreign jurisdictions outside the EU.

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Orphan Drug Designation and Exclusivity

Regulation (EC) No 141/2000 and Regulation (EC)
No. 847/2000 provide that a medicinal product can be designated as an orphan medicinal product by the European Commission, upon satisfactory
scientific assessment by the EMA’s Committee for Orphan Medicinal Products (“COMP”), if the sponsor can establish: (1) that
the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition, where
either (i) such condition affects not more than five in ten thousand persons in the EU when the application is made, or (ii) without
incentives it is unlikely that the marketing of the drug in the EU would generate sufficient return to justify the necessary investment
in its development, and (2) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question
that has been authorized in the EU or, if such