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If we were to decide to establish a commercial-scale manufacturing facility in the future, we would require substantial additional funds
and be required to hire and train significant numbers of employees and comply with applicable regulations .如果我们决定建立一个商业规模的生产车间，在未来，我们将需要大量的额外资金来雇用和培训大量员工人数，并遵守合理的法规。
We are dependent on patents and other intellectual property rights. The validity, enforceability and commercial value of these rights
are highly uncertain.我们是依赖于专利和其他知识产权。这些权利的有效性，可执行性和商业价值具有高度的不确定性。
We must obtain, maintain and enforce patent and other rights to protect our intellectual property. The patent position of biotechnologyand pharmaceutical firms is highly uncertain and involves many complex legal and technical issues. There is no clear policy involving the breadth of claims allowed, or the degree of protection afforded, under patents in this area. Accordingly, patent applications owned by or licensed to us may not result in patents being issued. We are aware of others who have patent applications or patents containing claims similar to or overlapping those in our patents and patent applications. Because of these considerations and potential post-issuance events discussed below, it is generally difficult to determine the relative strength or scope of a biotechnology patent position in absolute terms at any given time.
Patents that we own or license may not enable us to preclude competitors from commercializing drugs, and consequently may not provide us with any meaningful competitive advantage.我们拥有的专利或许可证可能无法使我们能够排除竞争对手的商业化打击，因此这些可能没有为我们提供任何有意义的竞争优势。
We own or have licenses to a number of issued patents. The issuance of a patent, however, is not conclusive as to its validity or
enforceability, which can be challenged in litigation. Our patents may be successfully challenged. We may incur substantial costs in litigation seeking to uphold the validity of patents or to prevent infringement. If the outcome of litigation is adverse to us, third parties may be able to use our patented invention without payment to us. Third parties may also avoid our patents through design innovation.
Most of our product candidates, as well as RELISTOR, incorporate to some degree intellectual property licensed from third parties.
We can lose the right to patents and other intellectual property licensed to us if the related license agreement is terminated due to a breach by us or otherwise. Our ability, and that of our collaboration partners, to commercialize products incorporating licensed intellectual property would be impaired if the related license agreements were terminated.http://www.ukassignment.org/gjswgl/
The license agreements from which we derive or out-license intellectual property provide for various royalty, milestone and other
payment, commercialization, sublicensing, patent prosecution and enforcement, insurance, indemnification and other obligations and rights, and are subject to certain reservations of rights. While we generally have the right to defend and enforce patents licensed by us, either in the first instance or if the licensor chooses not to do so, we must usually bear the cost of doing so. Under our License Agreement, Salix generally has control over defense and enforcement of our RELISTOR patents. With respect to Japan, Ono has certain limited rights to prosecute, maintain and enforce relevant intellectual property. With most of our in-licenses, the licensor bears the cost of engaging in all of these activities, although we may share in those costs under specified circumstances.
We also rely on unpatented technology, trade secrets and confidential information. Third parties may independently develop
substantially equivalent information and techniques or otherwise gain access to our technology or disclose our technology, and we may be unable to effectively protect our rights in unpatented technology, trade secrets and confidential information. We require each of our employees, consultants and advisors to execute a confidentiality agreement at the commencement of an employment or consulting relationship with us.
These agreements may, however, not provide effective protection in the event of unauthorized use or disclosure of confidential information.
If we do not achieve milestones or satisfy conditions regarding some of our product candidates, we may not maintain our rights under
related licenses.如果我们没有达到里程碑或满足条件的一些候选产品，我们可能无法维持我们的相关生产的权利。
We are required to make substantial cash payments, achieve milestones and satisfy other conditions, including filing for and obtaining marketing approvals and introducing products, to maintain rights under our intellectual property licenses. Due to the nature of these agreements and the uncertainties of research and development, we may not be able to achieve milestones or satisfy conditions to which we have contractually committed, and as a result may be unable to maintain our rights under these licenses. If we do not comply with our licenseagreements, the licensors may terminate them, which could result in our losing our rights to, and therefore being unable to commercialize,related products.
If we infringe third-party patent or other intellectual property rights, we may need to alter or terminate a product development
program.如果我们侵犯第三方专利或其他知识产权，我们可能需要变更或终止的产品的开发程序。
There may be patent or other intellectual property rights belonging to others that require us to alter our products, pay licensing fees orcease certain activities. If our products infringe patent or other intellectual property rights of others, the owners of those rights could bring legalactions against us claiming damages and seeking to enjoin manufacturing and marketing of the affected products. If these legal actions aresuccessful, in addition to any potential liability for damages, we could be required to obtain a license in order to continue to manufacture or market the affected products. We may not prevail in any action brought against us, and any license required under any rights that we infringemay not be available on acceptable terms or at all. We are aware of intellectual property rights held by third parties that relate to products or technologies we are developing. For example, we are aware of other groups investigating PSMA or related compounds, monoclonal antibodiesdirected at targets relevant to PSMA ADC, and methylnaltrexone and other peripheral opioid antagonists, and of patents held, and patentapplications filed, by these groups in those areas.
While the validity of these issued patents, patentability of these pending patent applicationsand applicability of any of them to our programs are uncertain, if asserted against us, any related patent or other intellectual property rights could adversely affect our ability to commercialize our products.虽然这些已授权专利有着有效性，但是专利的这些悬而未决的问题，都将影响到产品的销售，其中任何的的专利的适用性都是不确定的，如果对我们而言，任何相关的专利或其他知识产权可能产生不利的影响对我们的产品商业化。 |
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