U.S. LICENSE AGREEMENT FOR LEVOCETIRIZINE

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Exhibit 10.43

Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.

U.S. LICENSE AGREEMENT FOR LEVOCETIRIZINE

BETWEEN

UCB S.A. , having its registered office at Allée de la Recherche, 60, 1070 Brussels, Belgium, acting in its own name and on behalf of its AFFILIATES, hereinafter "UCB" , on the one hand,

AND

SEPRACOR INC. , having its registered office at 84 Waterford Drive, Marlborough, MA 01752, USA, hereinafter "SEPRACOR" , on the other hand, (individually a Party and collectively the Parties)

WITNESSETH:

        WHEREAS, SEPRACOR owns patents relating to Levocetirizine;

        WHEREAS, UCB has expertise and resources in manufacturing, marketing, distribution and management of pharmaceutical products (more particularly in the field of respiratory diseases) and owns patents relating to Cetirizine and Levocetirizine; and

        WHEREAS, UCB desires to obtain an exclusive license under SEPRACOR's patents to manufacture, promote, distribute and sell pharmaceutical products containing Levocetirizine subject to the terms and conditions herein set forth and SEPRACOR is willing to grant said license.

         NOW, THEREFORE, IT HAS BEEN AGREED AS FOLLOWS:

ARTICLE 1—DEFINITIONS

        For purposes of this Agreement, initially capitalized terms used in this Agreement, whether used in the singular or plural, shall have the following meanings, unless the context clearly requires otherwise:

1.1

"ACTIVE INGREDIENT" means the pharmaceutical compound (-) Cetirizine, also known as Levocetirizine, or (-) [2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]a cetic acid, including pharmaceutically acceptable salts and esters thereof. For the avoidance of any doubt, the parties expressly agree that racemic Cetirizine is not included within the definition of ACTIVE INGREDIENT.

1.2

"AFFILIATE" shall mean, as to a party to this Agreement, any corporation or non-corporate business entity which controls, is controlled by, or is under common control with such party. A corporation or non-corporate business entity shall be regarded as in control of another corporation if it owns, or directly or indirectly controls, at least fifty (50%) percent of the voting stock of the other corporation, or (a) in the absence of the ownership of at least fifty (50%) percent of the voting stock of a corporation or (b) in the case of a non-corporate business entity, or non-profit corporation, if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non-corporate business entity, as applicable.

1.3

"CALENDAR QUARTER" shall mean a three (3) month period ending on March 31, June 30, September 30, and December 31 of each year.

1.4

"COMBINATION PRODUCT" means any PRODUCT containing ACTIVE INGREDIENT and a leukotriene inhibitor and/or a decongestant.

1.5

"MARKETING YEAR" means each calendar year during the term of this Agreement, provided that the first MARKETING YEAR shall begin on the first day of the month during which UCB first invoices PRODUCT in the TERRITORY and shall end on December 31 of the same year, and the last MARKETING YEAR shall begin on the last January 1 during the term of this Agreement and shall end upon its expiration or termination.

1.6

"MARKET SALES" means the sales of PRODUCT invoiced to an independent third party by UCB or by any of its sublicensees or AFFILIATE in the TERRITORY for all therapeutic indications. For the avoidance of doubt, in the event that sales of PRODUCT are invoiced by UCB to its AFFILIATES or sublicensees in the TERRITORY, such sales shall not be included in the MARKET SALES; rather, MARKET SALES shall include the invoiced sale by UCB AFFILIATES or sublicensee(s) to their customers.

1.7

"MONO-PRODUCT" means any PRODUCT containing the ACTIVE INGREDIENT as its sole pharmaceutically active substance.

1.8

"NET SALES" means the net value of MARKET SALES, being the gross amount minus (i) customary trade, quantity and cash discounts, rebates and chargebacks (including without limitation Medicaid rebates and product specific rebates to pharmacy benefit managers, HMO's and other managed care and healthcare organizations) actually allowed and taken (ii) allowance for credits actually given to customers for rejected, or returned products, (iii) costs of freight and insurance, if same are included in the gross amount invoiced and (iv) value added tax, sales tax, excise taxes, duties or other governmental charges, if same are included in the gross amount invoiced.

1.9

"PRODUCT" means any pharmaceutical product containing the ACTIVE INGREDIENT as an active substance. PRODUCT shall include MONO-PRODUCT and COMBINATION PRODUCT.

1.10

"SEPRACOR KNOW-HOW" shall mean information which (i) as of the effective date hereof, is a trade secret in the sole possession of SEPRACOR, which relates specifically to the manufacture, sale, distribution, registration, use or testing of ACTIVE INGREDIENT or PRODUCT, or (ii) hereafter, during the term of this Agreement, is developed or acquired or used by SEPRACOR as a trade secret and which relates specifically to the manufacture, sale, distribution, registration, use or testing of ACTIVE INGREDIENT or PRODUCT.

1.11

"SEPRACOR PATENT(S)" means the patents and patent applications in the TERRITORY listed in Schedules 1.11(a) SEPRACOR BASIC PATENT and 1.11(b) SEPRACOR COMBINATION PATENTS attached hereto, together with continuations, continuations in part, divisionals and reissues thereof in the TERRITORY, and any extensions of the foregoing.

1.12

"TERRITORY" means the United States (including Puerto Rico).

ARTICLE 2—OBJECT OF THE AGREEMENT

        2.1     Grant of license     Subject to the terms and conditions of this Agreement, SEPRACOR hereby grants UCB, and UCB hereby accepts, (a) an exclusive license, including the right to sublicense, within the TERRITORY, under SEPRACOR PATENTS to manufacture, have manufactured, use, promote, co-promote, distribute, offer for sale, sell or import PRODUCT in the TERRITORY, and (b) a nonexclusive license in the TERRITORY, including the right to sublicense within the TERRITORY, under SEPRACOR KNOW-HOW, to manufacture, have manufactured, use, promote, distribute, offer for sale, sell or import PRODUCT.

        2.2     SEPRACOR KNOW-HOW     Promptly upon execution of this Agreement and throughout the term hereof SEPRACOR shall disclose to UCB the SEPRACOR KNOW-HOW. At UCB's request, SEPRACOR shall request in writing from third parties towards which it may be bound by confidentiality obligations (if any) their consent to the disclosure, by SEPRACOR to UCB and its sublicensees, if any, of SEPRACOR KNOW-HOW.

        2.3     Trademark     UCB shall be free to select the trademark for the sale and marketing of PRODUCT in the TERRITORY; no rights in such trademark shall vest in or inure to the benefit of SEPRACOR.

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        2.4     PRODUCT Registration     

(a)

UCB shall, in its sole discretion, and at its sole expense, use reasonable efforts to obtain marketing approval from the U.S. Food and Drug Administration ( "FDA" ) to sell and promote MONO-PRODUCT in the TERRITORY;

(b)

UCB shall be responsible for conducting, to the extent UCB deems appropriate and at UCB's sole expense, clinical trials with the ACTIVE INGREDIENT and interacting with the FDA to obtain marketing registration for PRODUCT.

        2.5     Development Reports     UCB shall keep SEPRACOR generally advised within forty-five (45) days of the end of the second and fourth CALENDAR QUARTERS of each year, of the status of its development program for PRODUCT and discussions with the FDA regarding the registration of the PRODUCT until such time as UCB obtains marketing approval from the FDA for the MONO-PRODUCT. It is understood that UCB will not be required to disclose detailed information or confidential data to SEPRACOR relating to UCB's development programs or discussion with the FDA or UCB's regulatory filings.

ARTICLE 3—ROYALTIES

        3.1     Calculation     

(a)

In partial consideration for granting the license pursuant to Section 2.1 of this Agreement, UCB shall pay to SEPRACOR a running royalty at the rate of [**]percent ([**]%) of the total NET SALES of MONO-PRODUCT. Royalties under this Section 3.1(a) shall be payable until the earlier of (i) such time as all of the SEPRACOR PATENTS covering MONO-PRODUCT(S) and licensed hereunder expire, are held invalid or unenforceable by a United States Federal District Court or by a United States Court of Appeals (whichever comes first) in a decision unappealable or not appealed in the time allowed for appeal, and/or (ii) such time as MONO-PRODUCT is introduced in the Territory by a Third Party not authorized by UCB. Thereafter, in the event that all MONO-PRODUCTS not authorized by UCB are removed from the market as a consequence of enforcement of SEPRACOR PATENTS, the royalty obligation of this Section 3.1(a) shall recommence until such time as an unauthorized MONO-PRODUCT is once again introduced in the Territory.

(b)

In partial consideration for granting the license pursuant to Section 2.1 of this Agreement, UCB shall pay to SEPRACOR, on a product-by-product basis, a running royalty at the rate of [**]percent ([**]%) of the total NET SALES of COMBINATION PRODUCT. Royalties under this Section 3.1(b) shall be payable on a product-by-product basis until the earlier of (i) such time as all of the SEPRACOR PATENTS covering such COMBINATION PRODUCT and licensed hereunder expire, are held invalid or unenforceable by a United States Federal District Court or by a United States Court of Appeals (whichever comes first) in a decision unappealable or not appealed in the time allowed for appeal, and/or (ii) such time as such COMBINATION PRODUCT is introduced in the TERRITORY by a Third Party not authorized by UCB. Thereafter, in the event that such COMBINATION PRODUCT not authorized by UCB is removed from the market as a consequence of enforcement of SEPRACOR PATENTS, the royalty obligation of this Section 3.1(b) shall recommence as to that COMBINATION PRODUCT until such time as said unauthorized COMBINATION PRODUCT is once again introduced in the Territory.

        3.2     Financial Reporting     UCB shall provide a report in writing to SEPRACOR within forty-five (45) days of the end of each CALENDAR QUARTER which will set forth the NET SALES for the considered CALENDAR QUARTER and the detailed calculation of the royalties due to SEPRACOR pursuant to Section 3.1 for the same period.

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        3.3     Terms of payment     At the same time as the report required under Section 3.2 above, UCB shall pay to SEPRACOR at its address set forth in Section 3.7 below, the full amount of royalties due as per Section 3.1 hereabove for the said period. At the end of each MARKETING YEAR, UCB shall reconcile the amount of royalty due to SEPRACOR against the actual amounts paid for the MARKETING YEAR concerned. In case of underpayment by UCB, UCB shall promptly pay the difference; in case of overpayment by UCB, UCB shall be entitled to payment from SEPRACOR or offset the difference against the royalties due for the next CALENDAR QUARTER. Any such payment shall be made in U.S. Dollars.

        3.4     Taxes     All royalties to be paid to SEPRACOR by UCB pursuant to this Agreement shall be paid after deduction of the withholding taxes lawfully imposed thereon, which taxes shall be paid by UCB for the account of SEPRACOR; provided that UCB shall upon request supply SEPRACOR with original or certified copies of official certificates stating that the aforesaid taxes have been actually paid for the account of SEPRACOR. The previous sentence notwithstanding, the parties hereto will reasonably cooperate in completing and filing documents required under the provisions of any applicable tax laws or under any other applicable law, in order to enable UCB to make such payments to SEPRACOR without any deduction or withholding.

        3.5     Records     

(a)

UCB shall keep and maintain, and shall cause its AFFILIATES, sublicensees and assigns to keep and maintain, complete and accurate records and books of account in sufficient detail and form so as to enable royalties to be determined, including but not limited to, true and accurate records of sales of PRODUCT and calculations of NET SALES and royalties. SEPRACOR shall have the right to audit the records of UCB at its own expense using a nationally recognized firm of independent certified accountants. Such accountants will have access on reasonable notice to UCB and its AFFILIATES and sublicensees' records during reasonable business hours for the purpose of verifying royalties. Notwithstanding the foregoing, this right may not be exercised more than once in any calendar year, and once a calendar year is audited it may not be reaudited, and said accountant shall disclose to SEPRACOR and UCB only information relating solely to the accuracy of the reports provided to SEPRACOR and the payments made to SEPRACOR under this Agreement.

(b)

Any adjustment required as a result of an audit conducted under this Section 3.5 shall be made within forty-five (45) days after the date on which the accountant conducting the audit issues a written report to SEPRACOR and UCB containing the results of the audit. If any underpayment by UCB is greater than ten percent (10%) of the amount previously paid to SEPRACOR for the relevant quarter, the costs and expenses of the audit shall be paid for by UCB. In the case of overpayment, UCB may, at its option, offset royalties and interest (if any) payable to SEPRACOR by the amount of the overpayment, but otherwise SEPRACOR shall remit any such overpayment to UCB.

(c)

UCB shall have the right to contest the accountants' results. If the parties cannot reconcile their differences, the parties agree to have the issue resolved by a mutually acceptable third party accounting expert. The non-prevailing party, as determined by the expert, shall be liable for the cost of the proceeding and, if bad faith, gross negligence or intentional misconduct on the part of UCB is found by the expert, the expert may impose the whole or partial cost of the audit on UCB. If the expert finds that SEPRACOR pursued a frivolous claim, the expert may require SEPRACOR to pay all legal costs and expenses.

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        3.6    No part of any amount payable to SEPRACOR under this Agreement may be reduced due to any counterclaim, set-off, adjustment or other right which UCB might have against SEPRACOR, any other party or otherwise, except as expressly stated to the contrary in this Agreement.

        3.7    All payments to SEPRACOR pursuant to this Agreement shall be made by wire transfer, to Fleet Bank of Massachusetts, 75 State Street, Boston, Massachusetts 02109 (ABA #011000138) to Account No. [**]or such other bank or account as SEPRACOR may from time to time designate in writing.

ARTICLE 4—SALES

        4.1     Reasonable efforts     After MONO-PRODUCT is approved and launched into the Rx market according to a timetable established by UCB, UCB shall use reasonable efforts to sell MONO-PRODUCT within the TERRITORY and to promote the same to potential purchasers thereof, all in a manner consistent with the efforts used and decisions made by UCB in connection with other products of similar strategic and financial significance.

        4.2     Launch Date     UCB by itself and/or through a third party intends to launch MONO-PRODUCT into the Rx market at the most commercially advantageous time. UCB reserves for itself, however, the sole discretion of the timing of such launch. Both parties understand and agree that UCB shall not be required to launch before [**] and that UCB will generally keep SEPRACOR advised on a confidential basis of its proposed launch dates, if after [**].

ARTICLE 5—INTELLECTUAL PROPERTY RIGHTS

        5.1     Patent protection     SEPRACOR shall be responsible for maintaining and prosecuting at its own expense the SEPRACOR PATENTS.

        5.2     Registration of License     UCB shall be entitled to register the present license at any government offices if such registration is permissible or needed by law. SEPRACOR shall give UCB any powers and authorization necessary for this purpose. The expenses of such registrations shall be borne by UCB.

        5.3     Enforcement of SEPRACOR PATENTS     

        (a)   UCB and SEPRACOR shall promptly inform each other in writing of any suspected infringement of any SEPRACOR PATENTS that come to their attention. SEPRACOR shall have the right, but not the obligation, to take legal action against third parties for infringement of any SEPRACOR PATENTS in the TERRITORY, and shall promptly notify UCB of its intention whether or not to initiate legal action within any such legally imposed timeframe [but in no event later than ten (10) days before any deadline for filing suit which, if missed, would prejudice UCB's exclusive rights under this Agreement (e.g. the 45-day deadline imposed under 21 USC 355(j)(5)(B)(iii))] or if no such legally imposed deadline within forty-five (45) days of written notice to the other party. If SEPRACOR takes such legal action within such timeframe, or if no timeframe, within thirty (30) days following notification of its intention to take such action, it shall have full control thereover. UCB shall have the right to consult with SEPRACOR and be represented by its own counsel at its own expense, and SEPRACOR shall in good faith consider UCB's interests in the conduct of any such suit. UCB shall have the right, but not the obligation, prior to commencement of an action brought by SEPRACOR, to join such action as a party; provided, however, that SEPRACOR shall retain control of such action as set forth above. UCB shall reasonably cooperate with SEPRACOR in any such action. In the event that UCB has been joined in the action, no settlement, consent judgment or other voluntary final disposition of the action may be entered into without the consent of UCB. If UCB has been joined in the action,

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SEPRACOR shall not enter into any consent judgment or other voluntary final disposition of the