Company: ACHV
Filing Date: 2025-03-11
Form Type: 10-K
Source: 0000950170-25-036831
Chunk: 33

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-03-11
Form: 10-K
Item: Item 1
Chunk 33
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 the University of Bristol License Agreement, we had provided 100 grams of cytisinicline to the University of Bristol as an initial contribution. 

Summary of Milestone and Contingent Obligations by Product Candidate 

The following table sets forth the milestones and contingent obligations that we may be required to pay to third parties under the license and share purchase agreements described above. As described above, we will also be required to pay certain revenue-based royalties with respect to our product candidate. 

    Milestone Obligations to Third Parties
      
    Amount Payable 

    University of Bristol
      
    Up to $4,837,500(1) 

    Sopharma AD
     
    $2,000,000(2)

(1)Payable in connection with specific financing, development and commercialization milestones. 

(2)Payable contingent on regulatory approval by the FDA or EMA.

GOVERNMENT REGULATIONS 

We are heavily regulated in most of the countries in which we operate. In the United States, the principal regulating authority is the FDA. The FDA regulates the safety and efficacy of product candidates and research, quality, manufacturing processes, product approval and promotion, advertising and product labeling. In the EU, the EMA and national regulatory agencies regulate the scientific 

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evaluation, supervision and safety monitoring of product candidates, and oversee the procedures for approval of drugs for the EU and European Economic Area, or EEA, countries similar regulations exist in most other countries, and in many countries the government also regulates prices. Health authorities in many middle- and lower-income countries require marketing approval by a recognized regulatory authority, such as the FDA or EMA, before they begin to conduct their application review process and/or issue their final approval.

United States

It is anticipated that cytisinicline tablets could receive up to seven and a half years of data exclusivity under the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act.

Before a new pharmaceutical product may be marketed in the United States, the FDA must approve an NDA for a new drug. The steps required before the FDA will approve an NDA generally include non-clinical studies followed by multiple stages of clinical trials conducted by the trial sponsor; sponsor submission of the NDA to the FDA for review; the FDA’s review of the data to assess the drug’s safety and effectiveness; and the FDA’s inspection of the facilities where the product will be manufactured.

As a condition of product approval, the FDA may require a sponsor to conduct