Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 39

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 39
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 are eligible to receive tax credits if they meet
the following criteria: (i) are domiciled in Australia, (ii) have incurred at least $20,000 in eligible research and development expenses,
(iii) have conducted at least one eligible research and development activity, (iv) beneficial owner(s) with > 40 % beneficial ownership
when considered together do not have > $20 million AUD aggregated turnover on an annual basis. 60P Australia Pty Ltd meets all these
criteria, and will continue to do so in the future unless, considered together with any of our shareholders who have > 40% beneficial
ownership, have > $20 million AUD in aggregate annual turnover.

Under Section 28D of the Industry Research and
Development Act 198639, research and development activities conducted outside Australia are also potentially eligible if they
meet the following criteria: (i) they are approved in advance, (ii) they are linked to a core research and development activity conducted
in Australia, (iii) cannot be conducted in Australia for various reasons and (iv) the value of activities conducted overseas is less
than the value of activities conducted in Australia.

Government Regulation and Product Approvals 

Government authorities in the United States,
at the federal, state and local level, and in other countries and jurisdictions, including the European Union, extensively regulate,
among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling,
advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of pharmaceutical products.
The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent
compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and
financial resources.

    38
    See Industry Research and Development Act 1986 (legislation.gov.au).

    39
    See Australian Government R&D Tax Incentive - Overseas R&D:
    Information Sheet.

18

Review and Approval of Drugs in the United States 

In the United States, the FDA regulates, among
other things, the research, development, testing, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and
marketing, distribution, post approval monitoring and reporting and import and export of drugs in the U.S. to assure the safety and effectiveness
of medical products for their intended use under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and implementing regulations