Elite also has entered into an agreement with Mikah for a product to be developed. Elite will be responsible for the formulation, analytical development, clinical batch manufacture and validation work for the product and will seek approval of the product from the FDA pursuant to 505(b)2 of the Drug Price Competition Act. Upon approval, Elite will manufacture the product and the parties will negotiate in good faith a manufacturing and supply agreement for the product. Elite will also receive a royalty of five percent of net sales after product launch and prior to the introduction of the first generic of the product.
"These acquisition and development agreements continue our strategy of leveraging the manufacturing and development expertise of the company into products that we believe may generate positive cash flow to support our research activities," stated Jerry Treppel, Chairman and CEO.