产品索赔投保的必要性分析

Table of Contents 目录

 

          Research, development and commercialization of a biopharmaceutical often require choosing between alternative development andoptimization routes at various stages in the development process. 一家生物制药的研究，开发和商业化，往往需要在不同的阶段，在发展路线之间和公司的阶段性布局之间做出选择。
Preferred routes depend on subsequent discoveries and test results and cannotbe predicted with certainty at the outset. There are numerous third-party patents in our field, and we may need to obtain a license under a patentin order to pursue the preferred development route of one or more of our products or product candidates. The need to obtain a license woulddecrease the ultimate profitability of the applicable product. If we cannot negotiate a license, we might have to pursue a less desirabledevelopment route or terminate the program altogether.

 

We are dependent upon third parties for a variety of functions. These arrangements may not provide us with the benefits we expect.
我们是依赖于第三方的各种功能。种种迹象表明这些可能无法为我们提供了我们所期望的利益。

 

          We rely in part on third parties to perform a variety of functions. We are party to numerous agreements which place substantial

responsibility on clinical research organizations, consultants and other service providers for the development of our products. We also rely onmedical and academic institutions to perform aspects of our clinical trials of product candidates. In addition, an element of our research anddevelopment strategy has been to in-license technology and product candidates from academic and government institutions in order tominimize investments in early research. We have entered into agreements under which we are now dependent on Ono and Salix, respectively,for the commercialization and development of RELISTOR. We may not be able to maintain our relationships with them, or establish new onesfor RELISTOR or other drug candidates on beneficial terms. We may not be able to enter new arrangements without undue delays or expenditures, and these arrangements may not allow us to compete successfully.

 

We lack sales and marketing infrastructure and related staff, which will require significant investment to establish and in the

meantime may make us dependent on third parties for their expertise in this area.

 

          We have no established sales, marketing or distribution infrastructure. If we receive marketing approval for a pharmaceutical product, significant investment, time and managerial resources will be required to build the commercial infrastructure required to market, sell and support it. Should we choose to commercialize a product directly, we may not be successful in developing an effective commercial infrastructure or in achieving sufficient market acceptance. Alternatively, we may choose to market and sell products through distribution,co-marketing, co-promotion or licensing arrangements with third parties. We may also consider contracting with a third party professionalpharmaceutical detailing and sales organization to perform the marketing function for one or more products. To the extent that we enter intodistribution, co-marketing, co-promotion, detailing or licensing arrangements for the marketing and sale of product candidates, any revenueswe receive will depend primarily on the efforts of third parties. We will not control the amount and timing of marketing resources these thirdparties devote to our products.http://www.ukassignment.org/yylwdx/

 

We are exposed to product liability claims, and in the future may not be able to obtain insurance against claims at a reasonable cost or

at all.我们面临的产品责任索赔，并在未来可能无法以合理的成本获得保险的索偿。

 

          Our business exposes us to product liability risks, which are inherent in the testing, manufacturing, marketing and sale of

pharmaceutical products. We may not be able to avoid product liability exposure. If a product liability claim is successfully brought against us,our financial position may be adversely affected. We are indemnified by Salix under our License Agreement for product liability exposurearising from its marketing and sales of RELISTOR, and maintain our own product liability insurance coverage in the amount of $10.0 millionper occurrence, subject to a deductible and a $10.0 million annual aggregate limitation and other clinical trial or other insurance as required bycontract and local laws. Pursuant to our Transition Agreement, we released Wyeth from its indemnification responsibility for product liabilityexposure arising from its marketing and sales of RELISTOR.

 

          Product liability insurance for the biopharmaceutical industry is generally expensive, when available at all, and may not be available

to us at a reasonable cost in the future. Our current insurance coverage and indemnification arrangements may not be adequate to cover claimsbrought against us, and are in any event subject to the insuring or indemnifying entity discharging its obligations to us.

We handle hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how

we do business. If we are involved in a hazardous waste spill or other accident, we could be liable for damages, penalties or other forms

of censure.

 

         Our research and development work and manufacturing processes involve the use of hazardous, controlled and radioactive materials.We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of thesematerials. Despite procedures that we implement for handling and disposing of these materials, we cannot eliminate the risk of accidentalcontamination or injury. In the event of a hazardous waste spill or other accident, we could be liable for damages, penalties or other forms ofcensure. We may be required to incur significant costs to comply with environmental laws and regulations in the future.

 

If we lose key management and scientific personnel on whom we depend, our business could suffer.
如果我们失去了主要管理人员和科研人员，这些我们依靠的人，我们的业务可能会受到影响。

         We are dependent upon our key management and scientific personnel, the loss of whom could require us to identify and engage

qualified replacements, and could cause our management and operations to suffer in the interim. Competition for qualified employees amongcompanies in the biopharmaceutical industry is intense. Future success in our industry depends in significant part on the ability to attract, retain and motivate highly skilled employees, which we may not be successful in doing.