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Impax, Shire Resolve Generic Adderall XR Litigation - Update

Impax Laboratories Inc. (IPXL) Friday settled all pending litigation with Shire Plc. (SHPG,SHP.L) and its unit relating to supply of its authorized generic Adderall XR under a 2006 license-and-distribution deal.

As part of the settlement, the parties will submit a stipulation of dismissal for entry by the Court. Shire has agreed to make a one-time cash payment to Impax of $48 million upon the court's order of dismissal.

Impax commenced sales of authorized generic Adderall XR in October 2009. About a year later, Impax sued Shire for breach of contract and other related claims alleging that Shire failed to fill Impax orders for the authorized generic Adderall XR.

Shire filed a counterclaim against Impax relating to its ordering practices under the agreement. Under the terms of the settlement, Impax claims and Shire's counterclaims will be dismissed.

The parties have entered into an amended License and Distribution Agreement which will govern the future supply of authorized generic Adderall XR from Shire to Impax.

Following the end of the supply term on September 30, 2014, Impax will continue to have the right to sell its products on hand or owed to it under the agreement until depleted and will continue to pay a profit share to Shire on sales of such products.

Impax said it will continue to pursue approval of its pending Abbreviated New Drug Application for generic Adderall XR which was filed with the U.S. Food and Drug Administration in September 2003.

Adderall XR, a psycho-stimulant, is indicated in the treatment of attention deficit hyper activity disorder.

Impax closed at $20.25, up 1.40%, on the Nasdaq, while Shire is trading at $99.82, down 0.24%. In London, Shire closed at 2,107.00 pence, down 0.24%.

by RTT Staff Writer

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