Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 63

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 63
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 by all member states concerned. Part II is assessed separately by each member state concerned; strictly
defined deadlines for the assessment of clinical trial applications; and the involvement of the Ethics Committees in the assessment procedure
in accordance with the national law of the member state concerned but within the overall timelines defined by the Clinical Trials Regulation.

Data and Market Exclusivity in the European
Union 

In the European Union, new chemical entities
qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity. This data
exclusivity, if granted, prevents regulatory authorities in the European Union from referencing the innovator’s data to assess
a generic (abbreviated) application for eight years, after which generic marketing authorization can be submitted, and the innovator’s
data may be referenced, but not approved for two years. The overall ten-year period will be extended to a maximum of eleven years if,
during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic
indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in
comparison with existing therapies. Even if a compound is considered to be a new chemical entity and the sponsor is able to gain the
prescribed period of data exclusivity, another company nevertheless could also market another version of the product if such company
can complete a full MAA with a complete database of pharmaceutical tests, preclinical tests and clinical trials and obtain marketing
approval of its product.

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 drug products. Whether or not it obtains FDA approval for a product, the company would need to obtain the necessary approvals by the
comparable foreign regulatory authorities before it can commence clinical trials or marketing of the product in those countries or jurisdictions.
The approval process ultimately varies between countries and jurisdictions and can involve additional product testing and additional
administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer
than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in
another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory
process in others.

32

Periods of Authorization and