Jazz Pharmaceuticals PLC was originally incorporated in California in March 2003 and was reincorporated in Delaware in January 2004. The Company was originally formed as a private limited liability company in March 2005 under the name Azur Pharma Limited, and was subsequently re-registered as a public limited company under the name Azur Pharma Public Limited Company in October 2011. On January 18, 2012, the business of Jazz Pharmaceuticals, Inc. and Azur Pharma were combined in the Azur Merger in connection with which Azur Pharma was re-named Jazz Pharmaceuticals plc. It is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing differentiated products that address unmet medical needs. Its products includes Xyrem, Erwinaze, Prialt. Its commercial activities in the United States are dedicated to its marketed products Xyrem, Erwinaze, Prialt, FazaClo HD, FazaClo LD and Versacloz, as well as providing support for sales of certain of its other products. They have approximately 180 trained, experienced sales professionals who detail its marketed products to physicians in specialties appropriate for each marketed product in the United States. In Europe, they promote Erwinase to hematology and oncology specialists. The Company's commercial activities include marketing and related services and commercial support services. The Company also employ third party vendors, such as advertising agencies, market research firms and suppliers of marketing and other sales support related services, to assist with its commercial activities. Some of these competitors include Endo Health Solutions Inc., Forest Laboratories, Inc., Shire Pharmaceuticals, Inc., Teva and Valeant. Other than the manufacturing plant in Italy where they produce some active pharmaceutical ingredients, including the defibrotide drug substance, discussed in more detail below, the company do not have its own manufacturing capability for its products or product candidates, or their active pharmaceutical ingredients, or the capability to package its products. The research, testing, manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, sale, distribution, recordkeeping, importing and exporting of pharmaceutical products are subject to extensive regulation by the FDA, the European Commission and other regulatory authorities, and regulations differ from country to country. In the United States, the FDA, under the Federal Food, Drug and Cosmetic Act, or FDCA, and its implementing regulations, regulates the review, approval, manufacturing and marketing of pharmaceutical products.