These agreements also grant to each party license rights and expand the working relationship of the two companies to include development and licensing of future generations of the ProUroScan system.
Under the development and commercialization agreement, Artann will conduct and complete all remaining product development activities, clinical testing and evaluations, and submit an FDA regulatory submission for 510(k) approval. Artann will also supply ProUroCare with systems for pre-commercial testing and validations, marketing and clinical studies while also facilitating transfer of the product to a third party manufacturing partner.
Under the licensing agreement, Artann granted to ProUroCare an exclusive license to patent applications and trade secrets to mechanical imaging technology used in the diagnosis or treatment of urologic disorders of the prostate, kidney or liver. ProUroCare has granted Artann rights to its mechanical imaging patents for the breast field of use.
As part of the agreements, ProUroCare will provide to Artann consideration in the form of cash and ProUroCare common stock, along with royalty payments based on the ProUroScan’s worldwide net sales.
Richard Carlson, CEO of ProUroCare, said: “These are pivotal agreements for ProUroCare Medical and Artann in being able to move this product from development and into commercial distribution.”