UCB SA - BNP Paribas Fortis
UCB SA - BNP Paribas Fortis
UCB SA - BNP Paribas Fortis
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other U.S. federal and state government agencies, continue to seek price discounts. As proposed, the<br />
U.S. healthcare reform bill increases the rebates on pharmaceutical products for government plans,<br />
including Medicare and Medicaid. Some states have implemented, and other states are considering<br />
price controls or patient access constraints under the Medicaid programme, and some states are<br />
considering price-control regimes that would apply to broader segments of their populations that are not<br />
Medicaid eligible.<br />
The international patchwork of price regulation has led to different prices in different markets, and<br />
consequently there has been some third party trade in the <strong>UCB</strong> Group’s products from markets with<br />
lower prices. Such trade exploiting price differences between countries can undermine sales in markets<br />
with higher prices. As a result, it is expected that pressures on the pricing component of operating<br />
results will continue.<br />
The <strong>UCB</strong> Group operates in a heavily regulatory environment worldwide. Every aspect of its business<br />
is regulated by laws of the countries within which it conducts its business from clinical research and<br />
development, to manufacturing, to marketing and promotion of products in the market place, to pricing,<br />
and to pricing reporting. Any non-compliance with the laws can result in lengthy and costly<br />
investigations and litigations, substantial fines, both civil and criminal penalties, product withdrawals,<br />
plant shutdowns and overall reductions of revenue.<br />
(l) The <strong>UCB</strong> Group faces certain litigation risks, which may adversely affect the business.<br />
The outcome of legal proceedings in which <strong>UCB</strong> and/or certain of its subsidiaries are involved, or of<br />
potential future litigation, may adversely affect the business, financial condition and results of<br />
operations of the <strong>UCB</strong> Group. Legal proceedings may include (but are not limited to) regulatory<br />
investigations, defending claims or taking action to protect commercial or competitive interests,<br />
including patents, in a range of jurisdictions and a number of legal systems. The costs and potential<br />
economic consequences of any legal proceedings are difficult to quantify and, particularly in the case of<br />
product patent infringement and significant commercial litigation, may be high. Material legal<br />
proceedings may both impact the profit of the business and, if a patent suit were to result in an adverse<br />
judgment, prevent the <strong>UCB</strong> Group from continuing to market certain of its products. The <strong>UCB</strong> Group<br />
is a party to patent litigation involving Xyzal® in the U.S. and in Europe, product liability actions in the<br />
U.S. and elsewhere and in regulatory review of certain marketing practices in the U.S. None of these<br />
actions are currently viewed by the Board as having a material adverse impact on the <strong>UCB</strong> Group.<br />
Separately, the <strong>UCB</strong> Group has made and will continue to consider acquisition opportunities within the<br />
pharmaceutical industry. While the Issuer typically obtains warranties or representations from the seller<br />
of such asset or business with respect to certain legal or factual issues, these warranties may not cover<br />
all of the problems that may arise following the acquisition, such as additional tax liabilities, and may<br />
not fully compensate the Issuer for any loss it may suffer in relation to the acquired asset or business. In<br />
addition, it may be difficult or impossible to enforce warranties or representations against a seller for<br />
various reasons, including the expiration of limitation periods or enforcement periods for such<br />
warranties or representations.<br />
(m) The <strong>UCB</strong> Group relies on its key personnel.<br />
The <strong>UCB</strong> Group is highly dependent upon the senior management and scientific team, the loss of whose<br />
services might impede the achievement of the scientific development and commercial objectives, or the<br />
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