Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 145

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 145
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. Where, during
the course of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.

The UK’s Innovative Licensing and Access
Pathway (“ILAP”) aims to accelerate the time to market of innovative medicinal products. It is open to both commercial and
non-commercial applicants, who are based in the UK or global, and who are developing medicinal products which include products containing
new chemical entities, biological medicinal products, new indications and repurposed medicinal products. It comprises of an Innovation
Passport designation and a Target Development Profile, and provides applicants with access to a toolkit to support all stages of the
design, development and approvals process. The major benefit of the ILAP scheme is that it provides applicants with opportunities for
enhanced regulatory and stakeholder input during the development of their medicinal products.

Marketing Authorization

To obtain a marketing authorization for a medicinal
product under the EU regulatory system, an applicant must submit an MAA, either under a centralized procedure administered by the EMA
or one of the procedures administered by competent authorities in EU member states (decentralized procedure, national procedure, or mutual
recognition procedure). A marketing authorization may be granted only to an applicant established in the EU.

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Regulation (EC) No 1901/2006 provides that prior
to obtaining a marketing authorization in the EU, an applicant must demonstrate compliance with all measures included in an EMA-approved
Pediatric Investigation Plan (“PIP”), covering all subsets of the pediatric population, unless the EMA has granted a product-specific
waiver, class waiver or a deferral for one or more of the measures included in the PIP. The Pediatric Committee of the EMA (“PDCO”),
may grant deferrals for some medicines, allowing a company to delay development of the medicine for children until there is enough information
to demonstrate its effectiveness and safety in adults. The PDCO may also grant waivers when development of a medicine for children is
not needed or is not appropriate, such as for diseases that only affect the elderly population. An application for marketing authorization
or a variation or a variation or a line-extension which is accompanied by the pediatric clinical trials conducted in accordance with
the PIP (even where such results are negative) are eligible for a six months extension of their supplementary protection certificate.
In the case of orphan medicinal products, a two-year extension of the orphan market exclusivity may be available. This pediatric reward