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Corporate Agreements

Arrow International Limited (Arrow)
In April 2008, Sepracor and Arrow, a European pharmaceutical company, signed a global license and development agreement for a levalbuterol/ipratropium inhalation solution combination product for the treatment of chronic obstructive pulmonary disease (COPD). The agreement includes rights to intellectual property covering the development and commercialization of the product. Under the terms of the agreement, Sepracor will fully fund all product development activities and manage the development program, including all interactions with the U.S. Food and Drug Administration (FDA) and other regulatory bodies. Sepracor is responsible for all commercial activities associated with the product worldwide. Arrow will be responsible for the formulation development, as well as the manufacture and supply of finished dosage forms.

Sepracor and Arrow also signed a technology license and development agreement for know-how and intellectual property rights related to stable sterile suspension formulations, for the use in developing ciclesonide in an inhalation solution. The agreement facilitates enhanced development of Sepracor's ciclesonide stand-alone product for the treatment of asthma as well as a planned ciclesonide arformoterol tartrate inhalation solution combination product for the treatment of COPD. The agreement also includes Arrow's "U-Bend" packaging technology, which allows increased accuracy in dosing through a novel U-Bend ampule design. Under this agreement, Sepracor will fully fund all product development activities and manage the development program, including all interactions with the FDA and other regulatory bodies. Sepracor will oversee the development program and is responsible for all commercial activities associated with the product in the U.S. Arrow will be responsible for formulation development.

Oryx Pharmaceuticals Inc. (Oryx)
In June 2008, Sepracor acquired Oryx Pharmaceuticals Inc., a specialty pharmaceutical company based in Canada and affiliated with the Arrow Group, which was subsequently renamed Sepracor Pharmaceuticals, Inc. (SPI). SPI's portfolio consists of 14 specialized products including NIASPAN®, ADVICOR®, ANGIOMAX®, NAPRELAN®, CUBICIN®, TRILEPTAL® and RESTORIL®. This acquisition creates a commercial platform for Sepracor in the Canadian specialty pharmaceutical market.

Nycomed GmbH (Nycomed)
In January 2008, Sepracor and Nycomed entered into an exclusive development, marketing and commercialization agreement for ciclesonide in the U.S. Ciclesonide is the active ingredient in ALVESCO® HFA Inhalation Aerosol for the treatment of asthma and OMNARIS® Nasal Spray for the treatment of allergic rhinitis. Sepracor commercially launched OMNARIS Nasal Spray in the U.S. in April 2008. In September 2008, Sepracor commercially introduced ALVESCO HFA through a staged launch that was initially targeted primarily to specialists. In early 2009, Sepracor expanded its sales and marketing efforts to include a broader group of physicians. Under the agreement, Sepracor has obtained development rights to several line extensions. These programs include OMNARIS HFA MDI, a Phase III candidate; ALVESCO Inhalation Solution, a preclinical candidate; and ALVESCO in combination with a long-acting beta-agonist, an early clinical candidate.

BIAL-Portela & Ca, S.A. (BIAL)
In December 2007, Sepracor and BIAL entered into an exclusive licensing agreement for the development and commercialization of BIAL’s antiepileptic compound, eslicarbazepine acetate, in the U.S. and Canada. Pursuant to the terms of the agreement, Sepracor submitted the U.S. New Drug Application (NDA) for this compound in March 2009 and is seeking marketing approval from the FDA. In August 2009, Sepracor's Canadian subsidiary, Sepracor Pharmaceuticals, Inc. submitted an application to the Therapeutic Products Directorate of Health Canada. Sepracor plans to market and sell this product under the brand name STEDESA™ in the U.S. and Canada, if and when approved.

Eisai Co. Ltd.
In July 2007, Sepracor entered into an agreement with Eisai Co. Ltd. (Eisai) for the development and commercialization of Sepracor's eszopiclone product for the Japanese market. Under the agreement, Eisai is responsible for completing the remaining clinical trials necessary for attaining marketing approval from the Japanese regulatory authorities, and contingent on regulatory approval, commercialization of the product in Japan.

Schering-Plough Corporation
In December 1997, Schering-Plough Corporation and Sepracor entered into a licensing agreement granting Schering-Plough exclusive worldwide rights to Sepracor’s patents relating to desloratadine. In January 2002, Schering-Plough launched CLARINEX® (desloratadine) 5 mg tablets in the U.S. for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older. In February 2002, Schering received FDA approval for CLARINEX tablets for the treatment of chronic idiopathic urticaria (CIU), or hives of unknown cause, and for the treatment of allergic rhinitis (AR), which encompasses both SAR and perennial allergic rhinitis (PAR).

sanofi-aventis (formerly Rhone-Poulenc Rorer SA)
In October 1999, Sepracor entered into an agreement with Rhone-Poulenc Rorer SA (RPR), a unit of Rhone-Poulenc SA, now sanofi-aventis, whereby Sepracor exclusively licensed RPR's preclinical, clinical and post-marketing surveillance data package relating to zopiclone, its isomers and metabolites, to develop, make, use and sell eszopiclone in the United States. Zopiclone, marketed by sanofi-aventis under the brand names of IMOVANE® and AMOBAN® for the treatment of insomnia, is available in approximately 80 countries worldwide but is not registered for use in the U.S. market.

Sepracor has the right to read and reference sanofi-aventis' regulatory filings related to zopiclone outside of the United States for the purpose of development and regulatory registration of eszopiclone outside of the U.S., and sanofi-aventis has assigned to Sepracor the foreign counterparts to the U.S. patent covering eszopiclone and its therapeutic use.

UCB Pharma
In June 1999, Sepracor entered into a licensing agreement with UCB Farchim S.A., an affiliate of UCB, relating to levocetirizine, an isomer of ZYRTEC® (cetirizine), for the treatment of allergies. Under the agreement, Sepracor has exclusively licensed to UCB all of Sepracor's patents and patent applications regarding levocetirizine in Europe and other countries. Sepracor currently earns royalties from UCB on sales of levocetirizine in European countries where the product is sold and where Sepracor owns relevant patents. XYZAL®/XUSALTM (levocetirizine) has been marketed in the EU since 2001. Sepracor entered into a separate licensing agreement with an affiliate of UCB in February 2006, pursuant to which, Sepracor exclusively licensed to UCB all of Sepracor's patents and patent applications in the U.S. regarding levocetirizine. Sepracor has retained its rights to this compound in Japan.

sanofi-aventis (formerly Hoechst Marion Roussel, Inc.)
Sepracor earns royalties from sanofi-aventis on sales of ALLEGRA® brand fexofenadine HCl, a nonsedating antihistamine for the treatment of allergic rhinitis, where Sepracor holds patents relating to fexofenadine (including Japan, Europe, Canada, and Australia).