Under the terms of the agreements, in exchange for payment of royalties, Sanofi-Aventis US has agreed to grant Barr and Teva a license to certain patent rights to permit Barr and Teva to sell generic versions of Allegra 30mg, 60mg, and 180mg tablets in the US, and to grant Barr a license to certain patent rights to sell generic versions of Allegra D-12 and Nasacort AQ in the US at a future date.
In each case, the license is to be non-exclusive, will allow generic entry prior to the expiration of Sanofi-Aventis US’s patents, and will not preclude Sanofi Aventis US’s own marketing of a generic version of these products. No license is granted with respect to any other Allegra product.
With respect to Allegra, for which Barr and Teva already market a US generic, royalties are to be retroactively applied to past sales. Royalty rates under the Allegra D-12 and the Nasacort AQ licenses will take into account the number of AB-rated generics of these products on the US market.
The license related to Nasacort AQ authorizes production and marketing of a generic of this product for the US market no earlier than June 2011 and at the latest December 2013.
The license related to Allegra D-12 authorizes production and marketing of a generic of this product for the US market no earlier than November 2009. For either product, these dates may be accelerated under certain conditions, notably in the event an AB-rated generic of Nasacort AQ or an authorized AB-rated generic of Allegra D-12 were to be launched in the US or in the event a final US court of appeals decision were to hold the related patents invalid, unenforceable or not infringed.
Under the agreements related to Allegra D-12 and Nasacort AQ, Barr will have an option to purchase the finished pharmaceutical product on a non-exclusive basis from Sanofi-Aventis US. Under the settlement agreements, Sanofi-Aventis US will dismiss without prejudice its US patent suits, including any damage claims, against Barr and Teva related to Sanofi-Aventis US’s US Allegra patents and the US patent suits against Barr related to its US Allegra D-12 and Nasacort AQ patents.