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UCB SA - BNP Paribas Fortis

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PART II: RISK FACTORS<br />

The following is a description of risk factors which are material in respect of the Bonds and the financial situation<br />

of the Issuer and which may affect the Issuer's ability to fulfil its repayment obligations under the Bonds and which<br />

prospective investors should consider carefully before deciding to purchase the Bonds. The sequence in which the<br />

following risk factors are listed is not an indication of their likelihood to occur or of the extent of their commercial<br />

consequences. The following statements are not exhaustive: prospective investors should read and consider all of<br />

the information provided in this Prospectus or incorporated by reference in this Prospectus and should make their<br />

own independent evaluations of all risk factors and consult with their own professional advisers if they consider it<br />

necessary. Terms defined in “Terms and Conditions of the Bonds” below shall have the same meaning where used<br />

below.<br />

1. FACTORS THAT MAY AFFECT THE ISSUER’S ABILITY TO FULFIL ITS OBLIGATIONS<br />

UNDER THE BONDS<br />

(a) The loss of patent protection or other exclusivity or ineffective patent protection for marketed<br />

products may result in loss of sales to competing products.<br />

Patent protection is considered, in the aggregate, to be of material importance in the <strong>UCB</strong> Group’s<br />

marketing of its products in the EU, the U.S. and in most other major markets. Patents covering<br />

products that the <strong>UCB</strong> Group has introduced normally provide market exclusivity, which is important<br />

for the successful marketing and sale of its products and its ability to reinvest the proceeds of sales into<br />

research and development. Similarly, many products, upon approval by regulatory authorities, benefit<br />

from “data exclusivity”. This exclusivity is a recognition of the unique work (typically clinical work)<br />

performed to demonstrate the safety and efficacy of a product. Exclusivity is an important asset<br />

enabling the <strong>UCB</strong> Group to lawfully avoid competition from identical or similar products. The <strong>UCB</strong><br />

Group will seek patents and data exclusivity, where the opportunity exists, covering each of its products<br />

in each of the markets where it intends to sell the products and where meaningful patent protection is<br />

available.<br />

Even if the <strong>UCB</strong> Group succeeds in obtaining patents covering its product, third parties may challenge<br />

or seek to invalidate or circumvent its patents and patent applications. It is important for the business of<br />

the <strong>UCB</strong> Group to successfully defend the patent rights that provide market exclusivity for its products.<br />

Patent litigation and other challenges to the patents of the <strong>UCB</strong> Group are costly and unpredictable and<br />

may deprive the <strong>UCB</strong> Group of market exclusivity for a patented product or, in some cases, third party<br />

patents may prevent the <strong>UCB</strong> Group from marketing and selling a product in a particular geographic<br />

area.<br />

Generic drug manufacturers, particularly in the U.S., may seek marketing approval for pharmaceutical<br />

products currently under patent protection by attacking the validity or enforceability of a patent. The<br />

more successful the product is commercially, the more likely the patent covering the product will be<br />

challenged by generic manufacturers. If a generic manufacturer succeeds in invalidating a patent<br />

protecting one of the products of the <strong>UCB</strong> Group, that product could be exposed to generic competition<br />

before the expected expiration date of the patent. If one or more important products lose patent<br />

protection in profitable markets, sales of those products are likely to decline significantly as a result of<br />

generic versions of those products becoming available. The results of operations of the <strong>UCB</strong> Group<br />

may be adversely affected by such sales decline. Decisions adversely impacting the <strong>UCB</strong> Group’s<br />

patents could also result in third party claims by, for example, direct and indirect purchasers and state<br />

A11250830/2.25/23 Oct 2009 14<br />

A4 - 4

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