Pursuant to the settlement agreement, the parties have agreed to terminate the collaboration agreement.
In addition, in consideration of Elite’s agreement to terminate the collaboration agreement and to relinquish to TPN all rights and interest in the Abbreviated New Drug Application (ANDA) for methadone hydrochloride approved by the US Food and Drug Administration (FDA), TPN made a cash payment to Elite.
As part of the settlement agreement, TPN also acknowledges that Elite may develop a generic product containing methadone of any strength (including the filing of an abbreviated new drug application relating to such product) and that nothing in the settlement agreement restricts Elite from developing, commercializing, manufacturing and distributing any pharmaceutical product similar to, or which may compete with, the Product or the ANDA filed in connection with the product.
Reportedly, Elite and TPN had entered into a development, commercialization, manufacturing and distribution agreement of a generic pharmaceutical product – methadone hydrochloride 10 mg tablet.
Later TPN alleged that Elite breached certain obligations in connection with the product collaboration agreement.
In the lawsuit, Elite asserted counterclaims against TPN arising out of the collaboration agreement, and sought damages of no less than $1,125,000 from TPN.