UCB SA - BNP Paribas Fortis
UCB SA - BNP Paribas Fortis
UCB SA - BNP Paribas Fortis
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(g) Distilbène Litigation<br />
As of the date hereof, entities of the <strong>UCB</strong> Group have been named as defendants in more than one<br />
hundred actions, the majority of which have been filed in France. Approximately 70 of these actions are<br />
active. The claimants to these actions claim that their mothers took Distilbène, a former product of the<br />
<strong>UCB</strong> Group, during their pregnancy, and that the claimants suffered either clear cell adenocarcinoma of<br />
the cervix, malformations of the genital track or dysplasia/squamous cells cancer as a consequence of<br />
this exposure. These actions include six claims of premature births due to genital track anomalies.<br />
<strong>UCB</strong> is unable to estimate the total number or types of Distilbène related cases that may be filed in the<br />
future, nor is <strong>UCB</strong> able to estimate the total liability nor whether such liability will be fully insured as a<br />
result of these cases.<br />
(h) MetadateCD Litigation<br />
A suit is pending in the District Court of Delaware in the U.S. against KV Pharmaceutical Company,<br />
which has filed an ANDA application with Paragraph IV certification for the 40, 50 and 60 mg strengths<br />
of MetadateCD. Discovery is ongoing with a trial expected during the second quarter of 2010 and<br />
the applicable 30 month stay expiring in September 2010. Depending on the outcome of this litigation,<br />
generic versions of one or more of these strengths of MetadateCD could possibly enter the market in<br />
the third quarter of 2010.<br />
(i) Xyzal® Litigation<br />
In major European countries, <strong>UCB</strong> holds an exclusive licence under a patent owned by Sepracor Inc.<br />
which covers the main antihistamine indications of Xyzal®. These patents have been challenged by<br />
generic companies in certain European countries and the United States.<br />
Depending on the outcome of these litigations and certain regulatory challenges in European countries,<br />
it is possible that generic versions of Xyzal® may enter the market in key European countries later in<br />
2009, and in the U.S. in 2010.<br />
(j) Apotex Inc.<br />
Apotex Inc., a generic company based in Canada, has commenced a claim against <strong>UCB</strong> (as the former<br />
owner of the <strong>UCB</strong> bioproducts business sold to Lonza in 2006) and Lonza Braine <strong>SA</strong> (a subsidiary of<br />
Lonza) claiming for damages for failure to deliver desmopressin on time, in quantity and within<br />
specifications, which Apotex Inc. alleges made it impossible to launch the product in Canada and the<br />
U.S. in it’s anticipated timeframe. Apotex Inc. has accused <strong>UCB</strong> and Lonza Braine <strong>SA</strong> of committing<br />
to provide certain volumes of desmopressin which were not delivered.<br />
In addition to this claim by Apotex Inc., <strong>UCB</strong>’s former agent S&D Chemicals (Canada) Limited has<br />
introduced a parallel claim against <strong>UCB</strong> and Lonza Braine <strong>SA</strong> for lost commission due to failed orders<br />
for desmopressin.<br />
Proceedings have commenced in the Ontario courts, and <strong>UCB</strong> is currently working with Canadian<br />
counsel to prepare a full defence to this claim. It is not possible to assess the likelihood or the amount,<br />
if any, of financial exposure to the <strong>UCB</strong> Group.<br />
A11250830/2.25/23 Oct 2009 89