Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 64

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 64
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 Renewals 

Marketing authorization is valid for five years
in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance
by the EMA or by the competent authority of the authorizing member state. To this end, the marketing authorization holder must provide
the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all
variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to
be valid. Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the competent
authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. Any authorization
which is not followed by the actual placing of the drug on the European Union market (in case of centralized procedure) or on the market
of the authorizing member state within three years after authorization ceases to be valid (the so-called sunset clause).

Orphan Drug Designation and Exclusivity

Regulation 141/2000 provides that a drug shall
be designated as an orphan drug if its sponsor can establish: that the product is intended for the diagnosis, prevention or treatment
of a life-threatening or chronically debilitating condition affecting not more than five in ten thousand persons in the European Community
when the application is made, or that the product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously
debilitating or serious and chronic condition in the European Community and that without incentives it is unlikely that the marketing
of the drug in the European Community would generate sufficient return to justify the necessary investment. For either of these conditions,
the applicant must demonstrate that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question
that has been authorized in the European Community or, if such method exists, the drug will be of significant benefit to those affected
by that condition.

Regulation 847/2000 sets out criteria and procedures
governing designation of orphan drugs in the European Union. Specifically, an application for designation as an orphan product can be
made any time prior to the filing of an application for approval to market the product. Marketing authorization for an orphan drug leads
to a ten-year period of market exclusivity. This period may, however, be reduced to six years if, at the end of the fifth year, it is
established that the product no longer