Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 147

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 147
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 marketing in a member state of the EEA, this national authorization can be recognized in other member states through the mutual recognition
procedure. If the product has not received a national authorization in any member state at the time of application, it can be approved
simultaneously in two or more member states through the decentralized procedure.

Following its departure from the EU, the UK has
introduced changes to its national licensing procedures, including procedures to prioritize access to new medicines that will benefit
patients, ILAP (described above) and new routes of evaluation for novel products and biotechnological 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