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Note 13 - Commitments and Contingencies
3 Months Ended
Sep. 30, 2025
Notes to Financial Statements  
Commitments and Contingencies Disclosure [Text Block]

Note 13 - Commitments and Contingencies

 

EXXUA Exclusive Commercialization Agreement

 

On June 5, 2025, the Company entered into the Commercialization Agreement with Fabre-Kramer, pursuant to which the Company acquired certain rights and obligations in connection with the commercialization of EXXUA in the United States. As consideration for the Commercialization Agreement, the Company made an upfront cash payment of $3.0 million to Fabre-Kramer in June 2025, which was capitalized as a definite-lived intangible asset (see Note 7 - Intangible Assets for further detail). Within 45 days of the one-year anniversary of the first product launch of EXXUA in the United States, the Company has agreed to make a second $3.0 million payment (the “Second Payment”). The Second Payment may be increased to $5.0 million if first year EXXUA net revenue meet or exceed $35.0 million. Additionally, the Company has agreed to pay Fabre-Kramer certain milestone payments ranging from $5.0 million to over $100.0 million per year based on sales milestones after a certain level of net revenue are achieved with a threshold of $100.0 million in net revenue and the Company will pay 10% of net revenue exceeding $1.0 billion. The Company has also agreed to pay royalty fees throughout the term of the Commercialization Agreement based on the Company’s net revenue of EXXUA as follows: (i) initially 28% of net revenue and increasing to 39% if net revenue exceed $300.0 million in any year during the term until such net revenue reach a reduced royalty trigger; and (ii) after reaching such royalty trigger, 24.5% and increasing to 35.5% if net revenue exceed $300.0 million in any year during the term. The Company will also pay a supply price of 3% of net revenue less its cost of goods sold, increasing to 4% of net revenue if annual net revenue exceed $300.0 million. The Commercialization Agreement also contains customary clauses for pharmaceutical commercialization agreements, including, among others, post-marketing obligations, regulatory matters, and indemnification.

 

The Commercialization Agreement can be terminated at any time upon mutual agreement between the Company and Fabre-Kramer. Either party can terminate the Commercialization Agreement at any time upon written notice for a material default or breach if the material default or breach is not cured within (1) 90 days after written notice or (2) in the case of a breach that cannot be cured within 90 days, within a reasonable period not exceeding 120 days after written notice. Additionally, either party can terminate the Commercialization Agreement at any time upon writing notice if (1) either party withdraws EXXUA from the market in the United States for safety reasons or (2)(i) the FDA materially restricts the indications for EXXUA, or (ii) federal or state pricing controls are imposed that would result in obvious or substantial loss of sales for EXXUA.

 

Pediatric Portfolio

 

The Company has the exclusive right to distribute and sell certain legacy products in the United States from agreements signed by the Company. The initial term of the agreement was 20 years. The Company pays Tris a royalty equal to 23.5% of net revenue from the products.

 

Legal Matters

 

Granules Paragraph IV

 

On October 31, 2024, the Company received a Paragraph IV Certification Notice Letter (the “Notice Letter”) from Granules Pharmaceuticals, Inc. (“Granules”), stating that it intends to market a generic version of Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (“Adzenys”) before the expiration of all patents currently listed in the FDA’s publication of approved drug products with therapeutic equivalence evaluations (the “Orange Book”). The Notice Letter states that Granules’ NDA for the generic version of Adzenys contains a Paragraph IV certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic version of Adzenys. On December 11, 2024, the Company filed a patent infringement lawsuit against Granules which triggered a stay precluding the FDA from approving Granules’ NDA for a generic version of Adzenys for up to 30 months or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first. On January 7, 2025, Granules submitted an answer to the complaint. On October 28, 2025, the case was reassigned to visiting judge, Judge Jennifer Choe-Groves of the United States Court of International Trade. The trial date has been moved to January 11, 2027, with all other scheduling dates remaining unchanged. The Company plans to vigorously enforce its intellectual property rights related to Adzenys.

 

Revive Investing

 

The Company had been named as a nominal plaintiff in a lawsuit by two shareholders against Armistice Capital Master Fund, Ltd (“Armistice”), entitled Revive Investing, LLC. et al v. Armistice Master Fund, Ltd. et al, Case 1:20-cv-02849-CMA-TPO, in the United States District Court for the District of Colorado, contending that Armistice was liable for short swing trading profits in violation of Section 16(b) of the Securities Exchange Act of 1934, as amended, for certain trades it made in Company stock in 2019 and 2020 and must disgorge those profits to the Company. That matter proceeded to trial before a jury, which on January 29, 2025, returned a verdict finding no liability. On March 6, 2025, the plaintiffs filed an appeal in the United States Court of Appeals for the Tenth Circuit. As with the original case, regardless of the outcome, this case will not have a materially adverse effect upon the Company’s financial condition, results of operations, or cash flows.