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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 />

A11250830/2.25/23 Oct 2009 21

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