Quarterly report pursuant to Section 13 or 15(d)

Commitments and Contingencies

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Commitments and Contingencies
6 Months Ended
Jun. 30, 2021
Commitments and Contingencies  
Note 10. Commitments and Contingencies

Note 10 - Commitments and Contingencies

 

1. Litigation 

    

We are involved in certain legal proceedings that arise from time to time in the ordinary course of our business. Except for income tax contingencies, we record accruals for contingencies to the extent that our management concludes that the occurrence is probable and that the related amounts of loss can be reasonably estimated. Legal expenses associated with the contingency are expensed as incurred. There is no current or pending litigation of any significance with the exception of the matters that have arisen under, and are being handled in, the normal course of business. 

   

a.

On August 28, 2019, a complaint was filed in the Superior Court of California, County of Los Angeles, West Judicial District, Santa Monica Courthouse, Unlimited Civil Division by Jeffrey Lion, an individual (“Lion”), and by Daniel Vallera, an individual (“Vallera”). Lion and Vallera are referred to jointly as the “Plaintiffs”. The complaint was filed against GT Biopharma, Inc. and its subsidiary Oxis Biotech, Inc. (either of them or jointly, the “Company”). The Plaintiffs allege breach of a license agreement between the Plaintiffs and the Company entered into on or about September 3, 2015. Lion alleges breach of a consulting agreement between Lion and the Company entered into on or about September 1, 2015. Vallera alleges breach of a consulting agreement between Vallera and the Company entered into in or around October, 2018. The Complaint seeks actual damages of $1,670,000, for the fair market value of the number of shares of GT Biopharma, Inc. that at the time of judgment represent 882,353 shares of such stock as of September 1, 2015, and that GT Biopharma, Inc. issue Lion the number of common shares of GT Biopharma, Inc. that at the time of judgment represent 882,353 such shares as of September 1, 2015.The Company filed an answer to the complaint denying many allegations and asserting affirmative defenses. Discovery has commenced and trial is scheduled for May, 2022. The Company believes the case is without merit and will defend it vigorously.

 

 

b.

On March 3, 2021 a complaint was filed by Sheffield Properties in the superior Court of California, County of Ventura. The litigation arises from a commercial lease entered into by GT Biopharma for office space in Westlake Village.

 

 

 

In July, 2021 we entered into settlement agreement with Sheffield Properties in the amount of $100,000 and such amount was recorded as part of accrued expenses of June 30, 2021.

 

2. Research and Development Agreement:

 

We are party to an exclusive worldwide license, patent and clinical trial agreements with the Regents of the University of Minnesota, to further develop and commercialize cancer therapies using TriKE technology developed by researchers at the university to target NK cells to cancer. Under the terms of the agreement, we receive exclusive rights to conduct research and to develop, make, use, sell, and import TriKE technology worldwide for the treatment of any disease, state or condition in humans. We are responsible for obtaining all permits, licenses, authorizations, registrations and regulatory approvals required or granted by any governmental authority anywhere in the world that is responsible for the regulation of products such as the TriKE technology, including without limitation the FDA in the United States and the European Agency for the Evaluation of Medicinal Products in the European Union.

 

Under the agreements, the University of Minnesota will receive an upfront license fee, royalty fees (upon commencement of commercial sales) ranging from 4% to 6%, minimum annual royalty payments of $0.25 million beginning in 2022, $2.0 million beginning in 2025, and $5.0 million beginning in 2027 and certain milestone payments totaling $3.1 million.

  

During the period ended June 30, 2021, the Company recorded research and development expenses of $507,000 pursuant to this agreements. We are presently evaluating GTB-3550, our lead TriKE therapeutic product candidate in a Phase I/II clinical trial.

3. Employee Compensation 

    

The following table summarizes the Company’s future financial commitment to certain employees pursuant to their respective employment agreements: 

  

Year ending

 

Amount

 

2021 remaining (remaining 6 months)

 

$ 1,211,000

 

2022

 

 

2,460,000

 

2023

 

 

2,460,000

 

2024

 

 

2,017,000

 

2025 and thereafter

 

 

591,000

 

Total

 

$ 8,739,000