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| SUPN > SEC Filings for SUPN > Form 8-K on 7-Feb-2013 | All Recent SEC Filings |
7-Feb-2013
Entry into a Material Definitive Agreement, Other Events, Financial
Effective August 23, 2012, Supernus Pharmaceuticals, Inc. ("Supernus" or the "Company") entered into a Commercial Supply Agreement with Patheon, Inc. (the "Agreement") that defines each party's responsibilities with respect to the manufacture, formulation, development and supply of commercial-grade quantities of oxcarbazepine, the active pharmaceutical ingredient required for the finished drug product, Oxtellar XR™ (the "Product"). The Company entered into the Agreement in anticipation of final approval by the U.S. Food and Drug Administration of the Product, which was received on October 19, 2012, and the commercial launch of the Product, which occurred on February 4, 2013.
Under the Agreement, the parties agreed that Patheon, Inc. 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 Patheon, Inc., the active pharmaceutical ingredient and any other materials required in connection with the manufacture of the Product, and Patheon, Inc. 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.
On February 1, 2013, Supernus issued a press release regarding the commercial launch of Oxtellar XR tablets in the US as a novel once-daily extended release antiepileptic drug indicated for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age. The Company also announced that its sales force of approximately 75 sales representatives would start promoting the product on February 4, 2013. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
(d) Exhibits
The following documents are filed as Exhibits pursuant to Item 9.01 hereof:
Exhibit 10.1* - Commercial Supply Agreement, dated August 23, 2012, by and among Patheon, Inc. and the Company.
Exhibit 99.1 - Press Release dated February 1, 2013 of the Company announcing the commercial launch of Oxtellar XR tablets in the US.
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