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* - Barriers to Competition <br /> While commercial antibodies have been produced in animals for decades, and the processes for this are well <br /> known and not patentable, GalaGen intends to protect its business opportunities in several ways. <br /> Trade Secrets <br /> GalaGen maintains a host of trade secrets related to its procurement and manufacturing system. <br /> Biologic Drug Development Regulations <br /> The biologics drug development pathway provides considerable protection, because for this class of drug <br /> products, there can be no generic products approved for marketing. This means that each competitor must <br /> proceed through the same laborious, painstaking pathway that GalaGen will have used to receive FDA <br /> approval. <br /> Patents <br /> GalaGen has filed several in a series of planned narrow and strong patents to protect various aspects of its <br /> immunization regimens and the use of antibodies for specific disease targets. <br /> In-Licensing Novel Technology <br /> GalaGen also intends to in-license unique and proprietary technology wherever possible, and has licensed <br /> product components from Institut Pasteur in Paris, France, the United States Department of Agriculture, <br /> MicroCarb, in Gaithersburg, MD, and Chiron Corporation, in Emeryville, CA. Patents either have been <br /> issued or are pending for these licensed components. <br />