产品知识产权技术协议写作方法

        Patents may not enable us to preclude competitors from commercializing drugs in direct competition with our products, and
consequently may not provide us with any meaningful competitive advantage. See Risk Factors.

我们的产品在商业化的药物专利可能不能使我们排除竞争对手的直接竞争，因此，可能没有为我们提供任何有意义的竞争优势,c存在风险因素。
         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 others investigating methylnaltrexone and other peripheral opioid antagonists as well as PSMA or related
compounds, and of patents and applications held or filed by others in those areas.
我们都意识到相关的产品或技术的重要性，我们正在开发使用第三方持有的知识产权。例如，我们都知道甲基纳曲酮和其他外围阿片受体拮抗剂以及PSMA的相关化合物，以及由他人持有或申请在这些领域的专利和应用。
While the validity of issued patents, patentability of claimedinventions in pending applications and applicability of any of them to our programs
are uncertain, patent rights asserted against us couldadversely affect our ability to commercialize or collaborate with others regarding our products.

          Research, development and commercialization of a biopharmaceutical product often require choosing between alternative
development and optimization routes at various stages in the development process. Preferred routes depend upon subsequent discoveries and
test results and cannot be identified with certainty at the outset. There are numerous third-party patents in our field, and we may need to obtain
a license under a patent in order to pursue the preferred development route of one or more of our product candidates. The need to obtain a
license would decrease the ultimate profitability of the applicable product. If we cannot negotiate a license, we might have to pursue a less
desirable development route or terminate the entire program altogether.http://www.ukthesis.org/Thesis_Tips/

Government Regulation 政府条例

          Progenics and its product candidates are subject to comprehensive regulation by the U.S. FDA and comparable authorities in other
countries. Pharmaceutical regulation currently is a topic of substantial interest in lawmaking and regulatory bodies in the U.S. and
internationally, and numerous proposals exist for changes in FDA and non-U.S. regulation of pre-clinical and clinical testing, safety,
effectiveness, approval, manufacture, labeling, marketing, export, storage, recordkeeping, advertising, promotion and other aspects of
biologics, small molecule drugs and medical devices, many of which, if adopted, could significantly alter our business and the current
regulatory structure described below. See Risk Factors.

         FDA Regulation. FDA approval of our product candidates, including a review of the manufacturing processes and facilities used to
produce them, are required before they may be marketed in the U.S. This process is costly, time consuming and subject to unanticipated delays,
and a drug candidate may fail to progress at any point.

         None of our product candidates other than RELISTOR has received marketing approval from the FDA or any other regulatory#p#分页标题#e#
authority. The process required by the FDA before product candidates may be approved for marketing in the U.S. generally involves:
我们的产品候选人以外的RELISTOR营销，需要批准或获得任何其他监管权威的允许。 FDA要求的产品前，产品可能被批准上市，在美国大致如下：

           pre-clinical laboratory and animal tests;

           submission to and favorable review by the FDA of an IND (Investigational New Drug) application before clinical trials may
          begin;

           adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for its intended indication
          (animal and other nonclinical studies also are typically conducted during each phase of human clinical trials);

           submission to the FDA of a marketing application; and

           FDA review of the marketing application in order to determine, among other things, whether the product is safe and effective
          for its intended uses.

         Pre-clinical tests include laboratory evaluation of product chemistry and animal studies to gain preliminary information about a
product’s pharmacology and toxicology and to identify safety problems that would preclude testing in humans. Products must generally be
manufactured according to current Good Manufacturing Practices, and pre-clinical safety tests must be conducted by laboratories that comply
with FDA good laboratory practices regulations.

         Results of pre-clinical tests are submitted to the FDA as part of an IND which must become effective before clinical trials may#p#分页标题#e#
commence. 临床前测试结果需要作为IND一部分提交给FDA的，临床试验之前必须是要有有效的开始的试验的。
The IND submission must include, among other things, a description of the sponsor’s investigational plan; protocols for each
planned study; chemistry, manufacturing and control information; pharmacology and toxicology information and a summary of previous
human experience with the investigational drug. Unless the FDA objects to, makes comments or raises questions concerning an IND, it
becomes effective 30 days following submission, and initial clinical studies may begin. Companies often obtain affirmative FDA approval,
however, before beginning such studies.