Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 141

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 141
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 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 method exists, the drug will be of significant benefit to
those affected by that condition. In the UK, the MHRA conducts an equivalent assessment, against criteria which have been tailored for
the UK population.

The COMP is required to re-assess the granted
orphan designation at the time of marketing authorization grant to ensure that it continues to meet the criteria for the designation
to be maintained. Otherwise, the orphan designation can be revoked. In relation to the UK, the MHRA does not grant orphan designations
during the development of the medicinal product. Instead, the MHRA will decide whether the criteria are satisfied at the point of marketing
authorization grant. An orphan drug designation provides a number of benefits, including fee reductions, fee