RISK FACTORS 4 States and (2) “march-in rights” requiring the grant of licenses challenged, invalidated, circumvented or rendered unenforceable. under such patent rights and technology to one or more third We cannot assure that either we or our licensors will be successful parties. When new technologies are developed with U.S. should such patents be challenged. If our or our licensors’ patent government funding, the U.S. government general ly obtains claims are rendered invalid or unenforceable, or narrowed in certain rights in any resulting patents and inventions, including scope, it could seriously impair our competitive position. a non-exclusive license to practice or have practiced on behalf of the U.S. government such patents and inventions. These Consequently, we would not be able to assert any such patents rights may further permit the U.S. government to disclose our to prevent others from using our technology for, and developing confidential information to third parties and to exercise march-in and marketing competing products to treat, these indications. It rights to allow third parties to use our licensed technology. The is also possible that we will fail to identify patentable aspects of U.S. government can exercise its march-in rights if it determines our research and development output in time to obtain patent that action is necessary because we or our licensors fail to achieve protection. practical application of the U.S. government-funded technology, or because action is necessary to alleviate health or safety needs, In some cases, the work of certain academic researchers in to meet requirements of federal regulations or to give preference the gene therapy field has entered the public domain, which to U.S. industry. In addition, our rights in such inventions may we believe precludes our ability to obtain patent protection be subject to certain requirements to manufacture products for certain inventions relating to such work. Consequently, we embodying such inventions in the United States. Any exercise wil l not be able to assert any such patents to prevent others by the U.S. government of such rights could harm our business, from using our technology for, and developing and marketing financial condition, results of operations and prospects. competing products to treat, these indications. It is also possible that we wil l fail to identify patentable aspects of our research In addition, licenses to additional third-party technology and and development output before it is too late to obtain patent materials that may be required for our development programs, protection. including additional technology and materials owned by any of our current licensors, may not be available in the future or may not be The patent position of biotechnology and pharmaceutical available on commercially reasonable terms, or at all, which could companies is highly uncertain, involves complex legal and factual have an adverse effect on our business and financial condition. questions and has, in recent years, been the subject of much litigation. As a result, the issuance, scope, validity, enforceability We or our licensors may be unable to obtain and maintain adequate and commercial value of our patent rights are highly uncertain. We patent protection for our product candidates and technology. cannot be certain that any patents will be granted with respect to Our success depends, in large part, on our and our licensors’ ability any of the pending patent applications that we own or are licensed to obtain and maintain patent protection in the United States, to us or any patent applications that we or our licensors may file the European Union and other countries with respect to our in the future. In addition, we cannot be certain that any of the proprietary product candidates and manufacturing technology. existing patents that we in-license or that we may in-license or We or our licensors have sought and we intend to further seek, to own in the future wil l adequately protect our technology and protect our proprietary position by filing patent applications in the our product candidates and methods of manufacturing the same United States, the European Union and other jurisdictions related and effectively prevent others from commercializing competitive to many of our novel technologies and product candidates that technologies and product candidates or otherwise provide any are important to our business. If we or our licensors fail to obtain competitive advantage. In fact, patent applications may not and maintain patent or other protection for this proprietary issue as patents at all. Even assuming patents issue from patent intellectual property, we could lose our rights to such intellectual applications in which we have rights, changes in either the patent property or our exclusivity with respect to those rights, and laws or interpretation of the patent laws in the United States and our competitors could market competing products using the other countries may diminish the value of our patents or narrow intellectual property. the scope of our patent protection. In the European Union, variation in the application of laws relating to the patentability of The patent prosecution process is expensive, time-consuming and biotechnological inventions, including the application of specific complex and we or our licensors may not be able to, or may choose exclusions to patentability means we cannot be certain that we not to, file, prosecute, maintain or enforce in a timely manner, or or our licensors can effectively protect our technology in order at all, all issued patents or patent applications that we believe are to prevent competitors from developing and commercializing necessary or desirable for our business. In addition, patents might competitive products and technology similar or identical to ours, not be issued or granted with respect to our patent applications and our ability to successfully commercialize our products and that are currently pending, and any issued patents may be technology may be adversely affected. 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