Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 72

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 72
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2). Furthermore,
an additional 1 year of market protection is available (8 + 2 + 1) where we obtain approval of a second indication having a significant
clinical benefit in the initial 8-year period.

Similarly, since the Biologics
Price Competition and Innovation Act (BPCIA) came into force in 2010, the United States provides 4 years of data exclusivity and 12 years
of marketing exclusivity for a new biologic. The periods of exclusivity run in parallel, meaning that the FDA will not accept a biosimilar
filing for 4 years and will not approve the biosimilar for a further 8 years (4 + 8).

Regulation and Procedures Governing Approval of Medicinal Products
in the European Union

In order to market any product
outside of the United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions
regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and
distribution of products. Whether or not it obtains FDA approval for a product, an applicant will need to obtain the necessary approvals
by the comparable foreign regulatory authorities before it can initiate clinical trials or marketing of the product in those countries
or jurisdictions. Specifically, the process governing approval of medicinal products in the European Union generally follows the same
lines as in the United States, although the approval of a medicinal product in the United States is no guarantee of approval of the same
product in the European Union, either at all or within the same timescale as approval may be granted in the United States. It entails
satisfactory completion of pharmaceutical development, non-clinical studies and adequate and well-controlled clinical trials to establish
the safety and efficacy of the medicinal product for each proposed indication. It also requires the submission to relevant competent authorities
for clinical trials authorization for a marketing authorization application, or MAA, and granting of a marketing authorization by these
authorities before the product can be marketed and sold in the European Union or its member states (as well as Iceland, Norway and Liechtenstein).
If we fail to comply with applicable requirements, we may be subject to, among other things, fines, suspension of clinical trials, suspension
or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Clinical Trial Approval

Pursuant to the
currently applicable Clinical Trials Directive 2001/20/EC and the Directive 2005/28/