关于市场接受度的决定性因素研究

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         Market acceptance of approved products such as RELISTOR also is affected by the timing of regulatory approvals, product launches

and reimbursement programs for existing and expanded uses by our collaborators or generic, over-the-counter or other competitors;
priceincreases for the product and relative prices of competing products; product development efforts for new indications; availability of sufficientcommercial quantities of the product; success in arranging for necessary sublicense or distribution relationships; and general andindustry-specific local and international economic pressures such as those experienced worldwide over the last five years.

 

Marketplace acceptance depends in part on competition in our industry, which is intense.市场接受，部分取决于我们的行业竞争中，这是激烈的。

 

          The extent to which any of our products achieves market acceptance will depend on competitive factors. Competition in our industry

is intense, and it is accentuated by the rapid pace of technological development.
There are currently marketed products that will compete withthe product candidates that we are developing. There are product candidates in pre-clinical or clinical development that target the side effects ofopioid pain therapy, and a marketed product for the treatment of post-operative ileus could compete with RELISTOR. Many of ourcompetitors have substantially greater research and development capabilities and experience and greater manufacturing, marketing, financialand managerial resources than we do. These competitors may develop products that are superior to those we are developing and render ourproducts or technologies non-competitive or obsolete. If our product candidates receive marketing approval but cannot compete effectively inthe marketplace, our operating results and financial position would suffer. Competition with respect to our technologies and products is basedon, among other things, product efficacy, safety, reliability, method of administration, availability, price and clinical benefit relative to cost;timing and scope of regulatory approval; sales, marketing and manufacturing capabilities; collaborator capabilities; insurance and otherreimbursement coverage; and patent protection. Competitive disadvantages in any of these factors could materially harm our business andfinancial condition.

 

If we or our collaborators are unable to obtain sufficient quantities of the raw and bulk materials needed to make our products,

development and commercialization of our product candidates could be slowed or stopped.如果我们或我们的合作者无法获得我们的产品所需要的原材料和大宗材料足够的数量，候选产品的开发和商业化可能会减慢或停止。

 

         Salix or Ono may not be able to fulfill manufacturing obligations for RELISTOR, either on their own or through third-party suppliers.

Our existing arrangements with suppliers for our other product candidates may not result in the supply of sufficient quantities of our productcandidates needed to accomplish our clinical development programs, http://www.ukassignment.org/fxgllw/ and we may not have the right and in any event do not currently have thecapability to manufacture these products if our suppliers are unable or unwilling to do so. We currently arrange for supplies of critical rawmaterials used in production of our product candidates from single sources. We do not have long-term contracts with any of these suppliers.Any delay or disruption in the availability of raw materials would slow or stop product development and commercialization of the relevantproduct. A delay or disruption of supplies of RELISTOR would have a material adverse effect on the RELISTOR franchise, and therefore onour business as a whole.

 

Manufacturing resources could limit or adversely affect our ability to commercialize products.
制造资源可能会限制或对产品的商业化产生不利影响。

 

        Under our License Agreement, Salix is responsible for obtaining supplies of RELISTOR, including contracting with contract

manufacturing organizations (CMOs) for supply of RELISTOR active pharmaceutical ingredient (API) and subcutaneous and oral finished

drug product. These arrangements may not be on optimally-advantageous terms, and as a result of our royalty and other interests in

RELISTOR’s commercial success will subject us to risks that the counterparties may not perform optimally in terms of quality or reliability.

 

         We engage third parties for manufacturing product candidates and means of administration for them, which may not be optimally

cost-effectiveIn doing so, we also do not control many aspects of the manufacturing process, including compliance with cGMP and other

regulatory requirements. We may not be able to obtain adequate supplies from third-party manufacturers in a timely fashion for development orcommercialization purposes, and commercial quantities of products may not be available from contract manufacturers at acceptable costs.

 

          In order to commercialize our product candidates successfully, we or our collaborators would need to be able to manufacture or

arrange for the manufacture of products in commercial quantities, in compliance with regulatory requirements, at acceptable costs and in atimely manner. Manufacture of our product candidates can be complex, difficult to accomplish even in small quantities, difficult to scale-up forlarge-scale production and subject to delays, inefficiencies and low yields of quality products. The cost of manufacturing some of our productsmay make them prohibitively expensive.
If adequate supplies of any of our product candidates or related materials are not available on a timely basis or at all, our clinical trials could be seriously delayed, since these materials are time consuming to manufacture and cannot be readily obtained from third-party sources.如果没有足够的产品和资料，我们所有的临床试验可能被严重的延迟，因为这些材料制造是费时和从第三方获得是不容易的。