Common use of For U.S Clause in Contracts

For U.S. If one of our suppliers or manufacturers fails to perform adequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts to find new suppliers or manufacturers. We may also face delays in the development and commercialization of SM-88 and any other drug product we may develop. Our reliance on third parties may require us to share our trade secrets, which increase the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed. We may enter into license agreements with third parties with respect to SM-88 any other drug products we may develop that may place the development of SM-88 and any other drug products partially or entirely outside of our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us and, if our collaborations are not successful, SM-88 and any other drug products we may choose to develop may not reach their full market potential. Our future operational success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel. We expect to expand our development, regulatory and marketing capabilities and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. Business disruptions (domestic and/or international) could seriously harm our future revenue and financial condition and increase our costs and expenses. Our internal computer systems or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug development program. Substantial amounts of information concerning our products, employees, consultants, vendors, service providers and ongoing business are stored digitally and are subject to threats of theft, tampering, or other intrusion. Our business and operations would suffer in the event of system failures. We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively. Our ability to successfully commercialize our technology and drug candidate may be materially adversely affected if we are unable to obtain and maintain effective IP. We may not be able to protect our IP rights throughout the world. Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for noncompliance with these requirements. We may become involved in lawsuits or other proceedings to protect or enforce our patents or other IP, which could be expensive, time-consuming and unsuccessful. Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. We may not be successful in obtaining or maintaining necessary rights to IP through acquisitions and in-licenses. We may be unable to protect the confidentiality of our trade secrets, thus harming our business and competitive position. We may be subject to claims that our employees and outside contractors have wrongfully used or disclosed IP from their former employers and clients. IP litigation or proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities. If we do not obtain protection under the ▇▇▇▇▇-▇▇▇▇▇▇ Amendments and similar non-U.S. legislation for extending the term of patents covering SM-88 and any other drug product we may develop, our business may be materially harmed. If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected. Health care reform measures could hinder or prevent the commercial success of SM-88 any other drug product we may develop. If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected. Because we and our suppliers are subject to environmental, health and safety laws and regulations, we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities, which may adversely affect our business and financial condition. Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements. If generic manufacturers use litigation and regulatory means to obtain approval for generic versions of products on which our future revenue depends, our business will suffer. The marketing of SM-88, if approved, will be limited to use for the treatment of specific cancer indications and, if we want to expand the indications for which these drug candidates may be marketed, additional regulatory approvals will need to be obtained, which may not be granted. If SM-88 is approved for marketing and we are found to have improperly promoted off-label uses or if physicians misuse our products or use our products off-label, we may become subject to prohibitions on the sale or marketing of our products, significant fines, penalties, sanctions and drug liability claims. Additionally, our image and reputation within the industry and marketplace could be harmed.