In connection with the settlement and license agreement, Medicis and Impax have agreed to terminate all legal disputes between them relating to Solodyn extended release tablets. Additionally, under terms of the agreements, Impax has confirmed that Medicis’s patents relating to Solodyn are valid and enforceable, and cover Impax’s activities relating to its generic product under abbreviated new drug application.
Under the terms of the settlement and license agreement, Impax has a license to market its generic versions of Solodyn 45mg, 90mg and 135mg under the Solodyn intellectual property rights belonging to Medicis no later than November 2011. Upon launch of its generic formulations of Solodyn, Impax may be required to pay Medicis a royalty, based on sales of those generic formulations by Impax under terms described in the settlement and license agreement.
Under the joint development agreement, Medicis and Impax will collaborate on the development of five strategic dermatology product opportunities, including an advanced-form Solodyn product. In return, Medicis will pay Impax $40 million at signing, along with additional milestone payments totaling up to $23 million upon successful completion of certain clinical and regulatory milestones.
Additionally, Medicis will pay Impax royalties based on sales of the advanced-form Solodyn product if and when it is commercialized by Medicis upon approval by the FDA. Medicis will share equally in the gross profit of the other four development products if and when they are commercialized by Impax upon FDA approval.
Jonah Shacknai, chairman and CEO of Medicis, said: We are excited to work with Impax on the development of advanced forms of Solodyn. By combining the formulation expertise of Impax with the clinical development and commercial focus of Medicis, we believe Solodyn is well poised to maintain its leadership position in the branded oral antibiotic category for the treatment of acne. Furthermore, we appreciate the opportunity to collaborate with Impax on additional products.