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         In addition to the risks we face in our research and development activities and our business as a publicly held commercial enterprise devoted to developing and commercializing high-technology consumer products, the transitioning of RELISTOR to our new partner Salix haspresented us with new risks.除了我们所面临的风险,我们的研究和开发活动,我们的业务,作为一家上市的商业企业,致力于开发和商业化的高科技消费产品,过渡的RELISTOR到我们新的合作伙伴呈现新的风险。
Major risks we face in both our own research and development efforts and Salix’s and Ono’s development andcommercialization efforts for RELISTOR include the following:
We are dependent on Salix, Ono and other business partners to develop and commercialize RELISTOR in their respective areas,
exposing us to significant risks.我们是依赖于沙柳,Ono和其他的商业合作伙伴在各自的领域开发和商业化,来使我们避免风险。
          We are and will be dependent upon Salix, Ono and any other business partner(s) with which we may collaborate in the future to
perform and fund development, including clinical testing of RELISTOR, make related regulatory filings and manufacture and market products,including for new indications and in new formulations, in their respective territories. Revenues from the sale of RELISTOR now dependentirely upon the efforts of Salix and its sublicensees, which have significant discretion in determining the efforts and resources they apply tosales of RELISTOR. Ono will have similar discretion with respect to sales in Japan. Neither may be effective in obtaining approvals for newindications and/or formulations, marketing existing or future products, or arranging for necessary sublicense or distribution relationship. Ourbusiness relationships with Salix, Ono and other partners may not be scientifically, clinically or commercially successful. For example, Salix is a larger pharmaceutical company than Progenics with a variety of marketed products. Unlike Wyeth and Pfizer, however, Salix is not a largediversified pharmaceutical company and does not have resources commensurate with such companies. Salix has its own corporate objectives,which may not be consistent with our best interests, and may change its strategic focus or pursue alternative technologies in a manner that results in reduced or delayed revenues to us. Changes of this nature might also occur if Salix were acquired or if its management changed.
           We may have future disagreements with Salix and Ono concerning product development, marketing strategies, manufacturing and
supply issues, and rights relating to intellectual property. Both of them have significantly greater financial and managerial resources than we do, which either could draw upon in the event of a dispute. Disagreements between either of them and us could lead to lengthy and expensive litigation or other dispute-resolution proceedings as well as extensive financial and operational consequences to us, and have a material adverse effect on our business, results of operations and financial condition.
  We are subject to extensive regulation, which can be costly and time consuming and can subject us to unanticipated fines and delays.
   Our business and products are subject to comprehensive regulation by the FDA and comparable authorities in other countries. Theseagencies and other entities regulate the pre-clinical and clinical testing, safety, effectiveness, approval, manufacture, labeling, marketing,export, storage, recordkeeping, advertising, promotion and other aspects of our products. If we violate regulatory requirements at any stage,whether before or after marketing approval is obtained, we may be subject to forced removal of a product from the market, product seizure,civil and criminal penalties and other adverse consequences. We cannot guarantee that approvals of proposed products, processes or facilities will be granted on a timely basis, or at all. If we experience delays or failures in obtaining approvals, commercialization of our product candidates will be slowed or stopped. Even if we obtain regulatory approval, the approval may include significant limitations on indicated uses for which the product could be marketed or other significant marketing restrictions. Under our License Agreement, we are dependent on Salix for compliance with these regulations as they apply to RELISTOR.
Our products may face regulatory, legal or commercial challenges even after approval.
          Even if a product receives regulatory approval:即使一个产品获得监管部门批准
        It might not obtain labeling claims necessary to make the product commercially viable (in general, labeling claims define the  medical conditions for which a drug product may be marketed, and are therefore very important to the commercial success of a  product), or may be required to carry Black Box or other warnings that adversely affect its commercial success.
         Approval may be limited to uses of the product for treatment or prevention of diseases or conditions that are relatively less  financially advantageous to us than approval of greater or different scope, or subject to an FDA-imposed Risk Evaluation and   Mitigation Strategy (REMS) that limits the sources from and conditions under which it may be dispensed.
       Side effects identified after the product is on the market might hurt sales or result in product recalls or withdrawals from the  market.

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