NEOS THERAPEUTICS,INC. (NASDAQ:NEOS) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry Into a Material Definitive Agreement
On December21, 2018, Neos Therapeutics,Inc. (the “Company”) entered into a confidential Settlement Agreement and Licensing Agreement (collectively, the “Agreement”), in each case between the Company, Neos Therapeutics, LP, a wholly-owned subsidiary of the Company, and Teva Pharmaceuticals USA,Inc. (“Teva”).This Agreement resolves all ongoing litigation involving the Company’s patents protecting its Cotempla XR-ODT®methylphenidate extended-release orally disintegrating tablets and Teva’s Abbreviated New Drug Application (the “ANDA”) filed with the U.S. Food and Drug Administration. Under the Agreement, the Company has granted Teva the right to manufacture and market its generic version of Cotempla XR-ODT under the ANDA beginning on July1, 2026, or earlier under certain circumstances. The Agreement provides for a full settlement of all claims that were asserted in the suit, subject to the acceptance of the U.S. District Court for the District of Delaware of a stipulation of dismissal. As required by law, the Agreement will be submitted to the U.S. Federal Trade Commission and U.S. Department of Justice.
The foregoing summary of the Agreement is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form10-K for the fiscal year ending December31, 2018.
Item 8.01. Other Events.
On December26, 2018, the Company issued a press release announcing its entry into the Agreement. A copy of the press release is attached hereto as Exhibit99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits:
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Exhibit No. |
Description |
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99.1 |
Press release dated December26, 2018 |
Neos Therapeutics, Inc. Exhibit
EX-99.1 2 a18-42036_1ex99d1.htm EX-99.1 Exhibit 99.1 Neos Therapeutics Announces Settlement with Teva on Cotempla XR-ODT® Patent Litigation DALLAS/FORT WORTH,…
To view the full exhibit click here
About NEOS THERAPEUTICS,INC. (NASDAQ:NEOS)
Neos Therapeutics, Inc. is a pharmaceutical company. The Company is focused on developing, manufacturing and commercializing products utilizing its modified-release drug delivery technology platform. Its segment is engaged in the development, manufacturing and commercialization of pharmaceuticals. It has utilized its platform to develop its product for the treatment of attention deficit hyperactivity disorder (ADHD). Its product candidates are extended-release (XR), medications in patient-friendly, orally disintegrating tablets (ODT) or liquid suspension dosage forms. Its branded product and product candidates incorporate over two of the prescribed medications for the treatment of ADHD, methylphenidate and amphetamine. Its modified-release drug delivery platform has enabled it to create extended-release ODT and liquid suspension dosage forms of the medications. It focuses on developing Adzenys XR-ODT, Cotempla XR-ODT and NT-0201.
