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SUPN > SEC Filings for SUPN > Form 8-K on 21-Aug-2013All Recent SEC Filings




Entry into a Material Definitive Agreement, Other Events, Financial

Item 1.01 Entry into a Material Definitive Agreement

Effective December 15, 2012, Supernus Pharmaceuticals, Inc. ("Supernus" or the "Company") entered into a Commercial Supply Agreement with Catalent Pharma Solutions, LLC (the "Agreement") that defines each party's responsibilities with respect to the manufacture, formulation, development and supply of commercial-grade quantities of topiramate, the active pharmaceutical ingredient required for the finished drug product, Trokendi XR (the "Product"). The Company entered into the Agreement in anticipation of final approval by the U.S. Food and Drug Administration (the "FDA") of the Product, which was received on August 16, 2013, and the commercial launch of the Product, which will occur during the next few weeks.

Under the Agreement, the parties agreed that Catalent Pharma Solutions, LLC will manufacture at its facility, in accordance with mutually agreed upon specifications and current good manufacturing practices, commercial quantities of the Product for the United States. Supernus will be responsible for providing, at no cost to Catalent Pharma Solutions, LLC, the active pharmaceutical ingredient and any other materials required in connection with the manufacture of the Product, and Catalent Pharma Solutions, LLC will be responsible for the manufacture, including processing, packaging and labeling, of the Product in accordance with the specifications.

The foregoing description of this Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.

Item 8.01 Other Events

On August 19, 2013, the Company issued a press release to announce the receipt of final approval from the FDA for Trokendi XR, a novel once-daily extended release formulation of topiramate for the treatment of epilepsy. The approval letter states that the FDA completed its review of the application and that Trokendi XR is approved effective August 16, 2013 for use as recommended in the agreed-upon labeling. The FDA granted a waiver for certain pediatric study requirements and a deferral for submission of post-marketing pediatric pharmacokinetic assessments that are due in 2019 followed by clinical assessments in 2025.The company expects to launch the product and for it to be available in pharmacies over the next few weeks. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

The following documents are furnished as an Exhibit pursuant to Item 1.01 hereof:

Exhibit 10.1* - Commercial Supply Agreement, dated December 15, 2012, by and among Catalent Pharma Solutions, LLC and the Company. (Filed herewith)

The following documents are furnished as an Exhibit pursuant to Item 8.01 hereof:

Exhibit 99.1 - Press Release dated August 19, 2013 of the Company announcing the final approval of Trokendi XR.

*Portions of this exhibit have been redacted and are subject to a confidential treatment request filed with the Secretary of the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities and Exchange Act of 1934, as amended.

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