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| DRRX > SEC Filings for DRRX > Form 8-K on 23-Sep-2008 | All Recent SEC Filings |
23-Sep-2008
Entry into a Material Definitive Agreement, Other Events, Financial Statements and Ex
On September 19, 2008, DURECT Corporation (the Company) and Alpharma Ireland Limited, an affiliate of Alpharma Inc., (Alpharma) entered into a development and license agreement granting Alpharma the exclusive worldwide rights to develop and commercialize ELADUR™, DURECT's investigational transdermal bupivacaine patch currently under development for the treatment of pain associated with post-herpetic neuralgia (PHN). Closing of the transaction is anticipated to occur in the fourth quarter of 2008 and is contingent solely on completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.
Under the terms of the agreement, upon closing of the transaction, Alpharma will pay the Company an upfront license fee of $20 million, with possible additional payments of up to $93 million upon the achievement of predefined development and regulatory milestones spread over multiple clinical indications and geographical territories as well as possible additional payments of up to $150 million in sales-based milestones. If ELADUR is commercialized, the Company would also receive a royalty on product sales. Upon closing of the transaction, Alpharma will control and fund the development program. The Company will perform development activities through completion of Phase 2 and formulation and manufacturing scale-up activities for the program, the costs of which shall be reimbursed by Alpharma. The term of the agreement shall commence upon the closing of the transaction and continue on a jurisdiction-by-jurisdiction basis until the later of fifteen (15) years from the date of first commercial sale of ELADUR or the expiration of patent coverage or data exclusivity in such jurisdiction. During the term of the agreement, subject to specified conditions, neither party nor their affiliates may develop or commercialize a transdermal patch containing bupivacaine. Upon expiration of the term of the agreement, the rights and licenses granted to Alpharma shall convert to fully paid-up, non-royalty bearing, perpetual rights and licenses. The agreement provides each party with specified termination rights, including the right of Alpharma to terminate at any time without cause and each party to terminate the agreement upon material breach of the agreement by the other party. The agreement also contains terms and conditions customary for this type of arrangement, including representations, warranties and indemnities.
The Company issued a press release announcing this event on September 22, 2008, a copy of which is attached hereto as Exhibit 99.1.
(d) Exhibits
99.1 Press Release of DURECT Corporation dated September 22, 2008
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