Under the agreement Hi-Tech Pharmacal will be responsible for submitting the abbreviated new drug application (ANDA) for the finished product, which will be filed under Hi-Tech Pharmacal’s name.
Following the approval of ANDA, Elite will take up the manufacturing responsibility of the intermediate product; however Hi-Tech Pharmacal will manufacture the finished product and will also take care of the sales and marketing of the final product.
Upon commercialization, Hi-Tech Pharmacal will pay for the manufacturing of the intermediate product and a percentage of the profits generated from the sale of the product to Elite.