EFTA01381308.pdf

Form S-I Table of Contetth Our Trademark% and Other Intellectual Proper', We believe that our intellectual property has substantial value and has contributed significantly to the success of our business. Our primary trademarks include "Blue Buffalo," "LifeSource Bits," "Life Protection Formula," "BLUE Basics," "BLUE Freedom," "BLUE Wilderness," the BLUE shield logo and the Blue Buffalo figure logo, all of which are registered with the U.S. Patent and Trademark Office. The Blue shield design logo is also registered or has a trademark registration pending in Canada, Mexico, Japan, Europe. Russia, China. Australia and approximately 26 other countries or registries. We also have numerous other trademark registrations and pending applications for product names and tag lines that are essential to our branding. Our trademarks are valuable assets that reinforce the distinctiveness of our brand and our consumers' favorable perception of our products. The current registrations of these trademarks in the United States and foreign countries arc effective for varying periods of time and may be renewed periodically, provided that we, as the registered owner, or our licensees where applicable, comply with all applicable renewal requirements including. where nen-Issry, the continued use of the trademarks in connection with similar goods. In addition to trademark protection, we own numerous URL designations. including www.bluebuffalo.com and www.bluesbuddies.com. We also rely on and carefully protect unpatented proprietary expertise, recipes and formulations, continuing innovation and other trade secrets to develop and maintain our competitive position. CON eminent Regulation Blue Buffalo, along with its contract manufacturers, distributors and ingredients and packaging suppliers. is subject to extensive regulation in the United States by federal, state and local government authorities including the FDA, the United States Department of Agriculture, U.S. Customs and Border Protection and the EPA. as well as state and local agencies. with respect to registrations, production processes. product attributes, packaging. labeling, storage and distribution. We believe that we arc in material compliance with all regulations applicable to our business. Pet Food-Related Regulation The FDA's Center for Veterinary Medicine, or CVM. regulates animal feed. including pet food. under the FFDCA and its implementing regulations. Although pet foods arc not required to obtain premarket approval from the FDA. any substance that is added to or is expected to become a component of a pct food must be used in accordance with a food additive regulation. unless it is generally recognized as safe, or GRAS, under the conditions of its intended use. A food additive regulation may be obtained through the submission of a food additive petition to the FDA demonstrating that a food additive is safe for its intended use and has utility. Use of a food ingredient that is neither GRAS nor an approved food additive may cause a food to be adulterated, in which case the food may not be legally marketed in the United States. The labeling of pet foods is regulated by both the FDA and some state regulatory authorities. FDA regulations require proper identification of the product, a net quantity statement, a statement of the name and place of business of the manufacturer or digributor, and proper listing of all the ingredients in order of predominance by weight. The FDA also considers certain specific claims on pet food labels to be medical claims and therefore subject to prior review and approval by the FDA. These include claims such as "hairball control," "improved digestibility" and "urinary tract health." In addition, the Food and Drug Administration Amendments Act of 2007 requires the FDA to establish ingredient standards and definitions for pet food, processing standards for pet food, and updated labeling standards for pet food that include nutritional and ingredient information. The FDA is currently working to implement these requirements. The FDA has recently identified concerns regarding products that provide nutrients in support of an animal's daily nutrient needs but which are also labeled as being intended for use to diagnose, curt, mitigate, treat or prevent disrase, thereby meeting the statutory definitions of both a food and a drug. In the past. the FDA has generally exercised discretion with regard to enforcement of the regulatory requirements applicable to animal 90 http://wow.see.gov/Archivestedgar/datatl609989/000119312515218883/d734898dsl.htmpf20/2015 10:30:13 AM) CONFIDENTIAL - PURSUANT TO FED. R. CRIM. P. 6(e) DB-SDNY-0080177 CONFIDENTIAL SDNY GM_00228361 EFTA01381308