Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 76

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 76
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 applies, or a deferral has been granted by the PDCO of
the obligation to implement some or all of the measures of the PIP until there are sufficient data to demonstrate the efficacy and safety
of the product in adults, in which case the pediatric clinical trials must be completed at a later date. Products that are granted a marketing
authorization with the results of the pediatric clinical trials conducted in accordance with the PIP are eligible for a six-month extension
of the protection under a supplementary protection certificate (if any is in effect at the time of approval) even where the trial results
are negative. In the case of orphan medicinal products, a two-year extension of the orphan market exclusivity may be available. This pediatric
reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

Regulatory Data Protection in the European Union

In the EEA, innovative
medicinal products approved on the basis of a complete independent data package qualify for eight years of data exclusivity upon
grant of a marketing authorization and an additional two years of market exclusivity pursuant to Regulation (EC) No. 726/2004, as
amended, and Directive 2001/83/EC, as amended. Data exclusivity prevents generic and biosimilar applicants from referencing the
innovator’s preclinical and clinical trial data contained in the dossier of the reference product when applying for a
marketing authorization for a period of eight years from the date on which the reference product was first authorized in the EEA.
During the additional two-year period of market exclusivity, a generic or biosimilar marketing authorization application can be
submitted, and the innovator’s data may be referenced, but no generic or biosimilar medicinal product can be marketed until
the expiration of the market exclusivity period. The overall 10-year period will be extended to a maximum of 11 years if,
during the first eight years of those 10 years, the marketing authorization holder obtains an authorization for one or more new
therapeutic indications which, during the scientific evaluation prior to authorization, is held to bring a significant clinical
benefit in comparison with existing therapies. Even if a compound is considered to be an innovative medicinal product so that the
innovator gains the prescribed period of data exclusivity, another company may market another version of the product if such company
obtained marketing authorization based on a MAA with a completely independent data package of pharmaceutical tests, preclinical
tests and clinical