Exhibit 10.44

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

LICENSE AGREEMENT

        THIS LICENSE AGREEMENT (this "Agreement") is made and entered into as of December 31, 2007 (the "Effective Date") by and between BIAL—PORTELA & C ^a , S.A., a Portuguese corporation having a principal place of business at À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal (hereinafter referred to as "BIAL") and SEPRACOR INC., a Delaware corporation having a principal place of business at 84 Waterford Drive, Marlborough, MA 01752, USA (hereinafter referred to as "SEPRACOR").

WITNESSETH

        WHEREAS, BIAL Controls (as defined below) the BIAL Patents and BIAL Know-How (each as defined below) relating to its proprietary compound BIA 2-093 (as defined below) and its use in the treatment of human diseases and conditions including, without limitation, epilepsy; and

        WHEREAS, SEPRACOR wishes to acquire licenses under the BIAL Patents, BIAL Know-How and BIAL Trademarks (each as defined below) for the purpose of developing, commercializing, marketing, offering for sale, selling, and distributing Licensed Products (as defined below) comprised of BIA 2-093 for use within the Field and Territory (each as defined below), and BIAL is willing to grant such licenses under the terms and conditions of this Agreement; and

        WHEREAS, BIAL wishes to acquire licenses under any future SEPRACOR Know-How and Development Intellectual Property (each as defined below) and SEPRACOR is willing to grant such licenses under the terms and conditions of this Agreement; and

        WHEREAS, the Parties (as defined below) will execute a Supply Agreement (as defined below) under which BIAL or its Affiliates will, unless otherwise agreed in writing by the Parties, supply all of SEPRACOR's requirements of Licensed Products to SEPRACOR for sale and distribution within the Field and Territory.

        NOW, THEREFORE, in reliance on the foregoing recitals and in consideration of the mutual covenants and promises set forth herein, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

        As used in this Agreement, the following terms have the following meanings, and the singular includes the plural and vice-versa:

        1.1   "Affiliate" means any person or entity that, as of the Effective Date or at any time in the future, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with a Party. For purposes of this definition, "control" means (i) the ownership of at least fifty percent (50%) of the voting securities of the entity or such lesser percentage which is the maximum allowed by applicable law; (ii) ownership of at least fifty percent (50%) interest in the assets, profits, or earnings of the entity; or (iii) the ability to otherwise direct the management and operations of the entity.

        1.2   "ANDA" means an abbreviated new drug application filed pursuant to 21 U.S.C. 355(j).

        1.3   "Approval" means the receipt of all authorizations, including, without limitation for any labeling and indications, from all governmental entity(ies) that are required to market and sell a Licensed Product within the Field and Territory.

        1.4   "BIA 2-093" means BIAL's proprietary compound (S)-(-)-10-acetoxy-10, 11-dihydro-5H-dibenz/b,f/azepine-5-carboxamide, known under the International Nonproprietary Name (INN) Eslicarbazepine Acetate.

        1.5   "BIA 2-093 IND" means the IND No. 67,466 effective as of the 20 ^th  December 2006.

        1.6   "BIA 2-093 Product" means BIA 2-093 in 800mg, 600mg and 400mg tablet formulations in fully finished and packaged consumer form.

        1.7   "BIAL Know-How" means (i) research and development information, unpatented inventions, trade secrets, proprietary materials, or any other type of proprietary or confidential technical data or information, including, without limitation, methods, techniques, processes, specifications, recipes, formulae, designs, plans, drawings, data, protocols, or preclinical and clinical studies, which are Controlled by BIAL as of the Effective Date and (a) reasonably necessary for the development, commercialization, importation, use, sale, or offer for sale of the Licensed Products, or (b) useful for the development, commercialization, importation, use, sale, or offer for sale of the Licensed Products to the extent that BIAL has developed or uses such know-how in connection with the Licensed Products; and (ii) subject to the provisions in Section 6.7, the BIA 2-093 IND and any other regulatory filings and correspondence and all data and information submitted in support of such filings or correspondence, which are Controlled by BIAL as of the Effective Date and relate solely to BIA 2-093 and/or the Licensed Products. The term BIAL Know-How includes any items encompassed by (i) and (ii) in the preceding sentence created after the Effective Date and during the Term of this Agreement and Controlled by BIAL.

        1.8   "BIAL Logo" means the logo included in Exhibit C , which BIAL may, at its own discretion, update from time to time.

        1.9   "BIAL Patents" means: (i) all U.S. and Canadian patents and patent applications Controlled by BIAL as of the Effective Date, covering the manufacture, use, import, offer for sale, and sale of the Licensed Products, including, without limitation, the patents and patent applications listed in Exhibit A; (ii) any U.S. or Canadian divisional, substitution, continuation, or continuation-in-part applications based on, directly or indirectly, relying for priority on, or having identical disclosure as, any of the U.S. or Canadian patent or patent applications in (i); (iii) any patent issuing from any of the applications in (i) or (ii); and (iv) any extensions, reissues, or reexaminations of any of the patents in (i) and/or (iii). BIAL Patents also include any Development Intellectual Property created by BIAL solely or jointly with SEPRACOR or that otherwise come under BIAL's Control during the Term of this Agreement covering the manufacture, use, import, offer for sale or sale of the Licensed Products. BIAL agrees to update Exhibit A from time to time with additional Development Intellectual Property created by BIAL solely or jointly with SEPRACOR or that otherwise come under BIAL's Control during the Term of this Agreement covering the manufacture, use, import, offer for sale or sale of the Licensed Products.

        1.10 "BIAL Studies" has the meanings set forth in Section 6.4(a).

        1.11 "BIAL Trademarks" means the marks, brand names and/or other indicators of source listed in Exhibit B for use in conjunction with the Licensed Products within the Field and Territory. Exhibit B may be updated from time to time with additional BIAL Trademarks for use with the Licensed Products within the Field and Territory, as selected pursuant to Sections 2.3(a) and 5.3(x). For the avoidance of doubt, the term "BIAL Trademarks" does not encompass the INN Eslicarbazepine Acetate, the BIAL Logo or any marks, brand names and/or other indicators of source not specifically listed in Exhibit B.

        1.12 "Business Day" means 9:00 am to 5:00 pm local on a day (other than a Saturday or Sunday) on which banks are open for business in Porto, Portugal, and Boston, MA USA.

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        1.13 "Change of Control" means any of the following events: (i) a Third Party (or group of Third Parties acting in concert) directly or indirectly, acquires more than fifty percent (50%) of the then outstanding capital stock entitled to vote for the election of SEPRACOR's directors; (ii) SEPRACOR consolidates with or merges into a Third Party, or a Third Party consolidates with or merges into SEPRACOR, which, in either event, more than fifty percent (50%) of the then outstanding capital stock of the surviving entity entitled to vote for the election of directors is not held by the parties holding at least fifty percent (50%) of the outstanding shares of SEPRACOR preceding such consolidation or merger; or (iii) SEPRACOR conveys, transfers or leases all or substantially all of its assets.

        1.14 "Commercialization Plan" means a plan with the primary objective of (i) preparing the market for and launching Licensed Products within the Field and Territory and (ii) continuing the marketing and sale of each Licensed Product after commercial launch has occurred. The term "Commercialization Plan" includes both the Strategic Commercialization Plans and the Annual Commercialization Plans referred to in Article 7 as well as any amendments thereto.

        1.15 "Commercially Reasonable Efforts" means efforts and resources that are consistent with those utilized by SEPRACOR or BIAL, as the case may be, for its own internally developed or in-licensed pharmaceutical products, which are at a similar stage in their development or product life and have similar market potential as the Licensed Products, and (ii) with those utilized by other pharmaceutical companies of similar size and resources for its own internally developed or in licensed pharmaceutical products for the same therapeutic areas as the Licensed Products and which are at a similar stage in their development or product life and have similar market potential as the Licensed Products.

        1.16 "Competing Product" means any pharmaceutical product with [**], which is defined as [**], and [**].

        1.17 "Controlled" means, with respect to any patents, copyrights, trademarks, know-how, trade secrets, proprietary information or data (including, without limitation, any regulatory filings and related data), or any other forms of comparable property rights protected by Federal law and foreign counterparts (collectively "Intellectual Property"), the possession of the right, whether directly or indirectly, whether by ownership, license or otherwise, to disclose, assign, or grant a license, sublicense or other right to or under such Intellectual Property, as provided for in this Agreement, without violating the terms of any agreement, contract, or any other arrangement with any Third Party. For the avoidance of doubt, Third Party Intellectual Property will only be considered "Controlled" by a Party, if the Party has right to disclose, assign, or grant a license, sublicense or other right to the other Party as provided for in this Agreement, at no additional cost and without prior Third Party approval. The term "Control" or "Controls" used in this context will also have a correlative meaning.

        1.18 "CMC Program" means the chemistry, manufacturing and control program relating to the BIA 2-093 Product or any other Licensed Products.

        1.19 "Development Intellectual Property" means any inventions or discoveries (whether or not patentable) made solely by one Party or jointly by the Parties in the performance of this Agreement or the Supply Agreement and any patent applications or patents claiming such inventions or discoveries, but only to the extent such Development Intellectual Property relates to BIA 2-093 or any Licensed Product. The term "Development Intellectual Property" also includes, to the extent Controlled by a Party, any inventions or discoveries (whether or not patentable) made solely by its sublicensee, a contractor, or an Affiliate of a Party or jointly by a Party and its sublicensee, a contractor, or an Affiliate in the performance of this Agreement or the Supply Agreement and any patent applications or patents claiming such inventions or discoveries.

        1.20 "Development Plan" has the meaning set forth in Section 6.2 below.

        1.21 "Development Studies" has the meaning set forth in Section 6.2 below.

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        1.22 "Effective Date" means the date first written above.

        1.23 "Exclusivity Rights" means a marketing or data exclusivity right conferred as a result of (i) designation as a drug for rare diseases or conditions under Sections 525 et seq. of the FD&C Act, (ii) approval of an NDA for a new chemical entity pursuant to 21 U.S.C. 355 and the FD&C Act or any relevant subsequent legislation, rules or regulations, (iii) the exclusive right granted by the FDA upon completion of pediatric studies requested by the FDA under Section 505A(a) of the FD&C Act, and any successor legislations thereof. The term "Exclusivity Rights" also means any marketing or data exclusivity rights that may be conferred under any applicable Canadian law.

        1.24 "Executive Officer" means with respect to SEPRACOR, a Senior Vice President or higher ranking officer, and with respect to BIAL, a Director or higher ranking officer.

        1.25 "FDA" means the United States Food and Drug Administration and its successor bodies.

        1.26 "FD&C Act" means the U.S. Food, Drug and Cosmetic Act, the rules and regulations of the FDA promulgated thereunder and as amended from time to time.

        1.27 "Field" means all human and non-human diagnostic, prophylactic and therapeutic uses of the Licensed Products for adjunctive use in Adult Partial Epileptic Seizures and any and all new indications, including but not limited to [**].

        1.28 "Fully Burdened Manufacturing Cost" means all costs incurred (i.e. paid or accrued) by BIAL, its Affiliates, agents or contractors in the manufacture and supply of BIA 2-093, the BIA 2-093 Product and Licensed Products, including without limitation direct and indirect costs, including overhead. Such costs to be calculated in accordance with International Financial Reporting Standards and using the normal cost accounting and allocation methods and procedures.

        1.29 "IND" means an Investigational New Drug Application filed with the FDA in support of conducting clinical development in the United States.

        1.30 "JSC" has the meaning set forth in Section 5.1.

        1.31 "Knowledge of BIAL" or words of like import means, with respect to the existence or absence of a fact, the actual knowledge of an officer of BIAL.

        1.32 "Licensed Products" means the BIA 2-093 Product and all other products (including any current or future dosages, formulations, improvements and/or delivery modes) comprising BIA 2-093 and all possible metabolites, salts, hydrates, polymorphs, crystalline forms, solvates and prodrugs thereof, including any present and future combination products containing BIA 2-093 or a metabolite, salt, hydrate, polymorph, crystalline form, solvate or prodrug thereof, as one of the active ingredients.

        1.33 "Liabilities" has the meaning set forth in Section 15.1.

        1.34 "Milestone Event" has the meaning set forth in Section 3.1(b).

        1.35 "Milestone Payments" has the meaning set forth in Section 3.1(b).

        1.36 "Minimum Sales" has the meaning set forth in Section 7.4.

        1.37 "NDA" means a New Drug Application to be filed with the FDA including all documents, data, and other information required to be included in such filing.

        1.38 "Net Sales" means the gross amounts received for sales of the Licensed Products by or on behalf of SEPRACOR, its Affiliates and/or its sublicensee (the "Selling Party") to Third Parties, less

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deductions actually allowed or specifically allocated to the Licensed Products by the Selling Party using U.S generally accepted accounting principals for:

•         (a)   transportation charges to the extent that they are included in the price or otherwise paid by the purchaser, including, without limitation, insurance, for transporting Licensed Products and separately identified on the invoice or in other documentation maintained in the ordinary course of business;

          (b)   trade, quantity and cash discounts, or charge-backs, refunds or other rebates actually granted to the customer (including, if applicable, hospitals or private or public health insurance entities);

          (c)   credits, rebates and allowances to the customer on account of rejection or returns of the Licensed Products (including wholesaler and retailer returns), or on account of non-discretionary retroactive price reductions affecting such Licensed Products;

          (d)   sales and excise taxes, other consumption taxes, customs duties and customary compulsory payments to governmental authorities and any other governmental charges imposed upon the production, importation, use or sale of the Licensed Products actually paid by SEPRACOR and separately identified on the invoice or in other documentation maintained in the ordinary course of business (but not including taxes assessed against the income derived from the sales of Licensed Products); and

          (e)   any other items actually deducted from gross invoices sales amounts as reported by the Selling Party in its financial statements in accordance with the U.S generally accepted accounting principals, applied on a consistent basis.

        In no event will any particular amount, identified above, be deducted more than once in calculating Net Sales (i.e., no "double counting" of reductions). Sales of the Licensed Products between SEPRACOR and its Affiliates or sublicensee will be excluded from the computation of Net Sales, but the subsequent resale of such the Licensed Products to a Third Party will be included within the computation of Net Sales.

        In the case of any sale or disposal for value, other than in an arms length transaction exclusively for money, such as barter or counter trade, Net Sales will be calculated as above on the value of the consideration received or the fair market value (if higher) of the Licensed Products in the country of sale or disposal.

        Any amounts hereunder will be determined from the books and records of SEPRACOR, its Affiliates and sublicensee maintained in accordance with US generally applied accounting practices consistently applied to all products of SEPRACOR.

        1.39 "Net Selling Price" means for the applicable period and for each respective Licensed Product (and, in relation to the BIA 2-093 Product, for each respective dosage) the amount corresponding to the total Net Sales of a Licensed Product divided by the actual number of units sold net of returns (for example, the total Net Sales of the BIA 2-093 Product for the applicable period divided by the total number of pills sold).

        1.40 "Paper NDA" means an application filed pursuant to 21 U.S.C. 505(b)(2).

        1.41 "Party" or "Parties" means SEPRACOR or BIAL when used in the singular or SEPRACOR and BIAL when used in the plural.

        1.42 "Product Liability Claim" has the meaning set forth in Section 15.7(a).

        1.43 "SEPRACOR Know-How" means (i) research and development information, unpatented inventions, trade secrets, proprietary materials, or any other proprietary or confidential technical data

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or information, including without limitation, methods, techniques, processes, specifications, recipes, formulae, designs, plans, drawings, data, protocols or preclinical and clinical studies which are Controlled by SEPRACOR during the Term of this Agreement and (i) are reasonably necessary for the manufacture, development, commercialization, importation, use, sale, or offer for sale of any Licensed Product, or (ii) useful for the manufacture, development, commercialization, importation, use, sale, or offer for sale of the Licensed Products to the extent that SEPRACOR has developed or uses such know-how in connection with the Licensed Products, and (ii) all IND/NDA and any other regulatory filings and correspondence and all data and information submitted in support of such filings or correspondence which are Controlled by SEPRACOR during the Term of this Agreement and which relate solely to the BIA 2-093 or any Licensed Products.

        1.44 "Supply Agreement" has the meaning set forth in Article 4.

        1.45 "Third Party" means any person or entity who or which is neither a Party nor an Affiliate of a Party.

        1.46 "Term" has the meaning set forth in Section 14.1.

        1.47 "Territory" means the United States of America and Canada.

        1.48 "Three Year Strategic Development Plan" means a Development Plan providing the information required in Section 6.3(b) for a period of three (3) years beginning on January 1 of the year following the date on which such Development Plan is approved. Notwithstanding the foregoing, the initial Three Year Development Plan will cover the three year period beginning on the date it is approved.

ARTICLE 2

GRANT OF RIGHTS

         Notwithstanding any other provision of this Agreement, no rights or obligations hereunder will be of any force or effect until payment by SEPRACOR of the license fee set forth in Section 3.1(a).

        2.1     Exclusive License :    BIAL grants to SEPRACOR an exclusive (even as to BIAL) license under the BIAL Patents and BIAL Know-How to use, market, distribute, import, commercialize, offer for sale and sell the Licensed Products under the BIAL Trademarks within the Field and Territory either directly on its own and/or through its Affiliates, sublicensee and/or distributors permitted hereunder. The license granted to SEPRACOR under this Section 2.1 does not include an exclusive right to use or practice the BIAL Patents and BIAL Know-How to develop Licensed Products or to have such Licensed Products developed on its behalf within the Field and the Territory.

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•         (a)   BIAL grants SEPRACOR the right to grant a sublicense only in Canada, provided that such sublicense conforms with the terms of this Agreement and the sublicensee expressly agrees to be subject to substantially similar obligations imposed to SEPRACOR under this Agreement, including without limitation the provisions of Sections 6.8, 7.6(b), 7.7, 8.1, 8.2 and 9.1.

          (b)   BIAL reserves to itself all rights in and to the Licensed Products, BIAL Patents, and BIAL Know-How for all uses outside of the Territory.

          (c)   SEPRACOR agrees not to use, market, commercialize, distribute, import, offer for sale or sell the Licensed Products outside of the Territory. SEPRACOR further agrees not to use, market, commercialize, distribute, import, offer for sale or sell any Licensed Products other than the BIA 2-093 Product until the Parties agree, in writing, to either (i) the terms and prices for the supply of such other Licensed Products by BIAL to SEPRACOR or (ii) absent such agreement, until such terms, supply prices and/or royalties are determined [**].

        2.2     Non-Exclusive License:     BIAL grants to SEPRACOR a worldwide, non-exclusive license, without any right to sub-license, under the BIAL Patents and BIAL Know-How to develop or have developed on its behalf, Licensed Products for use and sale within the Field and the Territory, subject to the limitations set forth in Article 6.

•         (a)   BIAL will provide SEPRACOR with a draft of the protocols of any planned development study to be conducted by or on behalf of BIAL or its licensees in the Territory and will consider in good faith any comments provided by SEPRACOR within the period of [**] upon receipt of the said draft by SEPRACOR. SEPRACOR will have the right to veto any such development study (including the use of BIAL Trademarks in connection therewith) by BIAL or on behalf of BIAL in the Territory if [**] within the Territory. In the event of a dispute between the Parties as to whether there is a reasonable likelihood that such development study (or use of BIAL Trademarks in connection therewith) will [**] within the Territory, [**].

        2.3     Trademark License:     BIAL grants SEPRACOR an exclusive (even as to BIAL), royalty-free license to use the BIAL Trademarks in connection with any Licensed Products that SEPRACOR uses, markets, promotes, distributes, imports, commercializes, offers for sale or sells within the Field and Territory either directly on its own and/or through its Affiliates, sublicensee, and/or distributors authorized under Section 2.1.

•         (a)   The Parties [**] the BIAL Trademarks. BIAL will own all right, title and interest in the BIAL Trademarks and the goodwill associated therewith and will be solely responsible for registering and maintaining such trademarks. If requested, SEPRACOR will [**], registration, and maintenance of the BIAL Trademarks.

          (b)   Any marketing, sale or distribution of Licensed Products by SEPRACOR, its Affiliates, sublicensee, or distributors under the license set forth in Section 2.1, will take place exclusively under the BIAL Trademarks, subject to each Party's rights set forth in Section 2.4. SEPRACOR will not file or obtain any trademark application or registration, or Internet domain name registration, comprised of or containing any BIAL Trademarks or the INN Eslicarbazepine Acetate, or any variations thereof, without BIAL's express written permission. SEPRACOR will use the BIAL Trademarks only in accordance with guidelines [**].

          (c)   BIAL reserves to itself all rights in and to the BIAL Trademarks outside of the Territory [**] in conjunction with any development and/or publication activities conducted in accordance with this Agreement.

          (d)   BIAL agrees that it will not use outside the Territory trademarks and trade names for the Licensed Products that are the same or confusingly similar to the BIAL Trademarks used in connection with the commercialization of Licensed Products within the Territory.

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•         (e)   In the event that the Parties agree, pursuant to Sections 2.3(a) and 5.3(x), not to use one or more of the brands, trademarks or indicators of source listed in, or otherwise added to, Exhibit B, such brands, trademarks or indicators will be considered excluded from Exhibit B, provided that such brands, trademarks or indicators will not be used in the Territory by BIAL without SEPRACOR's prior written consent, except as BIAL Trademarks are permitted to be used by BIAL hereunder.

        2.4     BIAL Logo License:     BIAL grants SEPRACOR a non-exclusive license to use the BIAL Logo on all packaging materials, promotional materials and documents that are used by SEPRACOR either directly on its own and/or through its sublicensee, contractors or distributors in connection with the development, promotion, marketing, offer for sale, sale, import and commercialization of the Licensed Products. SEPRACOR agrees that all such packaging materials, promotional materials and documents that are used by SEPRACOR, its sublicensee, contractors or distributors in connection with the development, promotion, marketing, offer for sale, sale, import and commercialization of the Licensed Products will contain with legible letters of a reasonable size the words "under license from [BIAL Logo]", unless BIAL determines, in its sole discretion, that such reference will be "under license from BIAL". SEPRACOR will also be permitted to include SEPRACOR's trade name, trademarks and other logos on any packaging materials, promotional materials or other documents with equal prominence as the BIAL Logo.

        2.5     Contracting:     SEPRACOR has the right to contract with Third Parties to perform its development, marketing, and commercialization responsibilities under this Agreement in accordance with the terms of this Agreement; provided (i) that SEPRACOR uses, markets, imports, distributes, offers for sale, sells and commercializes the Licensed Products at all times in its own name, (ii) that SEPRACOR uses Commercially Reasonable Efforts to ensure that its contractors assign to SEPRACOR any inventions or discoveries (whether or not patentable) made in the performance of the subcontract or, absent such assignment, that its contractors grant to SEPRACOR rights to any inventions or discoveries (whether or not patentable) made in the performance of the subcontract consistent with SEPRACOR's obligations to BIAL hereunder, including without limitation the provisions of Sections 6.8, 8.1 (b)(c)(d), 8.2 and 9.1 (b) and that SEPRACOR remains, at all times, solely responsible and liable to BIAL for all of the contractor activities and for any failure by a contractor to comply with the terms of this Agreement.

        2.6     Manufacture of the Licensed Products:     Unless otherwise agreed to by the Parties in writing or provided for in the Supply Agreement, SEPRACOR has no right to make or have made on its behalf, BIA 2-093, the BIA 2-093 Product or any other Licensed Product, and all Licensed Products will be supplied to SEPRACOR by BIAL or BIAL Affiliates in accordance with the terms of the Supply Agreement.

        2.7     Ownership of BIA 2-093 IND:     Within [**] after the Effective Date, BIAL will transfer all right, title and interest in the BIA 2-093 IND to SEPRACOR, subject to the reservation set forth in Section 2.7 (a), for the Term of this Agreement and will promptly notify the FDA in writing of its transfer to SEPRACOR. SEPRACOR will simultaneously notify the FDA in writing that the BIA 2-093 IND has been transferred to SEPRACOR and that SEPRACOR accepts all rights and responsibilities thereunder.

•         (a)   Subject to the exclusive licenses granted to SEPRACOR herein, BIAL retains all right, title and interest in all BIAL Know-How submitted in support of the BIA 2-093 IND, including but not limited to, all safety and effectiveness data, provided that SEPRACOR has the right to rely upon and utilize such BIAL Know-How during the Term to support any future regulatory applications or submissions to the FDA, Health Canada, or any other relevant regulatory bodies in the Territory related to the Licensed Products and to the extent consistent with the terms of this Agreement.

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•         (b)   BIAL reserves the right to use and refer to the BIA 2-093 IND and BIAL Know-How submitted in support of the BIA 2-093 IND, including but not limited to, all safety and effectiveness data for (i) any purpose, including without limitation, for development and regulatory activities in any country of the world, excluding the Territory (except in the event that the licenses granted by BIAL to SEPRACOR under Sections 2.1 and 2.3 convert to non-exclusive licenses pursuant to Section 7.4(b)), and (b) subject to Section 2.2(a), for the sole purpose of conducting permitted development activities within the Territory.

          (c)   Except as otherwise provided in Section 14.5(b), upon the expiration or the termination of this Agreement, all right, title, and interest in the BIA 2-093 IND will revert back to BIAL.

        2.8     Delivery of BIAL Know-How for Use under Sections 2.1 and 2.2:     

•         (a)     Existing BIAL Know-How:     BIAL will provide to SEPRACOR, as soon as reasonably practicable following the Effective Date, a copy of BIAL Know-How in existence prior to the Effective Date for use in accordance with the licenses set forth in Sections 2.1 and 2.2.

          (b)     New BIAL Know-How and BIAL Development Intellectual Property:     BIAL will as soon as reasonably practicable provide SEPRACOR with a copy of any BIAL Know-How and Developmental Intellectual Property that comes under BIAL's Control after the Effective Date. To the extent that BIAL licenses-in know-how or patents relating to a Licensed Product after the Effective Date, which is not Controlled by BIAL because prior authorization by and/or an additional payment to the licensor is required before it can be disclosed and/or sublicensed to SEPRACOR under Sections 2.1 and 2.2, BIAL will use Commercially Reasonable Efforts to obtain such rights for SEPRACOR, provided that SEPRACOR agrees, in writing, to: (i) comply with any terms that may apply to such disclosure/sublicensing; (ii) pay [**]; and (iii) pay [**]. BIAL will use Commercially Reasonable Efforts to obtain reasonable terms when negotiating SEPRACOR's sublicense.

          (c)   All BIAL Know-How disclosed to SEPRACOR under Section 2.8(a) and (b) above is subject to the terms and conditions of this Agreement, including without limitation, the confidentiality provisions of Article 10.

        2.9     Limitation to Territory:     

•         (a)   During the Term of this Agreement, SEPRACOR agrees not to directly or indirectly register, market or sell Licensed Products and/or solicit customers for the Licensed Products and/or use the BIAL Trademarks outside the Territory. SEPRACOR will promptly notify BIAL if it has reason to believe that any Licensed Product has been or will be exported from the Territory during the Term of this Agreement.

          (b)   Except as expressly permitted herein, during the Term of this Agreement, BIAL agrees not to directly or indirectly market or sell Licensed Products and/or solicit customers for the Licensed Products and/or use the BIAL Trademarks within the Territory. BIAL will promptly notify SEPRACOR if it has reason to believe that any Licensed Product has been or will be exported to the Territory during the Term of this Agreement other than pursuant to the Supply Agreement.

ARTICLE 3

PAYMENTS

        3.1     License Fees:     SEPRACOR will make the following payments to BIAL:

•         (a)   License Fee: Within five (5) Business Days after the Effective Date, SEPRACOR will pay BIAL Seventy-Five Million U. S. Dollars (US$75,000,000), as a licensing fee. This license fee is not refundable under any circumstances and is not creditable against the transfer prices and/or

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• royalties due under Article 4 or any other payments due by SEPRACOR under this Agreement or the Supply Agreement;

          (b)   Milestone Payments: SEPRACOR will make the following milestone payments (the "Milestone Payments") to BIAL upon each of the milestone events specified below (each, a "Milestone Event"):

•         (c)   SEPRACOR will report in writing (with proper written documentation evidencing same) the occurrence of each Milestone Event to BIAL within five (5) Business Days of the date on which the Milestone Event has occurred and will pay the corresponding Milestone Fee within thirty (30) days of the date on which the Milestone Event has occurred, regardless of whether two or more milestones occur at the same time. The Milestone Payments are not refundable under any circumstances and are not creditable against the transfer prices and/or royalties and/or other Milestone Payments due under Article 4 or any other payments due by SEPRACOR under this Agreement or the Supply Agreement.

        3.2     Tax Matters:     

•         (a)   All payments under Section 3.1 will be made in accordance with the terms of the treaty between Portugal and the United States to avoid double taxation.

          (b)   BIAL will pay and otherwise be responsible for all value added taxes and transfer taxes in connection with any payment made to BIAL pursuant to this Agreement for all applicable sales, goods and services.

          (c)   Any income or other tax that one Party hereunder is required to withhold and pay on behalf of the other Party hereunder with respect to amounts payable under this Agreement will be deducted from and offset against said amounts prior to payment to the other Party; provided, however, that in regard to any tax so deducted, the Party making the withholding will give or cause to be given to the other Party all assistance reasonably necessary to enable that other Party to claim exemption therefrom or credit therefor, and in each case will promptly furnish the Party on whose behalf amounts were withheld, proper evidence of the taxes paid on its behalf and execute and provide such Party with any documents reasonably necessary in connection therewith. Each Party will comply with reasonable requests of the other Party to take any proper actions that may minimize any withholding obligation. BIAL will provide to SEPRACOR a properly completed and executed Form W8-BEN prior to any payment made to BIAL. A properly completed and executed Form W8-BEN will be completed and provided annually to SEPRACOR.

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        3.3     Interest:     If SEPRACOR fails to make payment within any of the above stated timeframe, BIAL is entitled, without prejudice to any other right or remedy available to BIAL, to charge SEPRACOR interest (both before and after judgment) on the unpaid amount at the annual rate of [**]% ([**] percent) per annum calculated on a daily basis until payment is made in full.

ARTICLE 4

SUPPLY

        4.1     General:     Unless otherwise agreed to by the Parties, and without prejudice to BIAL's right to decide, in its sole discretion, not to supply, directly or through a BIAL Affiliate, Licensed Products (other than the BIA 2-093 Product which BIAL will supply pursuant to the Supply Agreement) to SEPRACOR, SEPRACOR will purchase all of its requirements of BIA 2-093 Product and other Licensed Products from BIAL or BIAL's Affiliates.

        4.2     Supply Agreement:     Promptly after the Effective Date and within the period of one hundred and eighty (180) days thereof (or as otherwise agreed in writing by the Parties), BIAL or a BIAL Affiliate and SEPRACOR or its Affiliate will negotiate in good faith and enter into a Supply Agreement (the "Supply Agreement") for the clinical supply of BIA 2-093, the supply of physician samples of the BIA 2-093 Product and the commercial supply of the BIA 2-093 Product.

        4.3     Commercial Supply—Additional Licensed Products:     

•         (a)   The Parties acknowledge and agree that transfer prices for supply to SEPRACOR of any Licensed Products, other than BIA 2-093 Products, will be negotiated in the future in good faith, and such transfer prices [**]. The Supply Agreement will be amended as necessary to reflect such transfer prices and any other necessary changes resulting from the addition of any Licensed Products.

          (b)   Should BIAL or a BIAL Affiliate not agree to supply a Licensed Product (other than the BIA 2-093 Product which BIAL will supply pursuant to the Supply Agreement) to SEPRACOR, [**].

          (c)   In the event that, within the period of [**] of written request of either Party, the Parties do not reach an agreement on the transfer prices and/or royalties mentioned in this Section 4.3, the following procedure will apply: [**].

        4.4     Generic Entry:     The Parties agree to negotiate in good faith a provision in the Supply Agreement to reflect the impact on the applicable transfer prices and/or royalties upon the entry into the market in each country within the Territory of a generic version of a Licensed Product, provided however that neither Party will be under an obligation to agree on any revised prices and/or royalties.

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ARTICLE 5

JOINT STEERING COMMITTEE

        5.1     Committee Formation:     The Parties will form a Joint Steering Committee (the "JSC"), with general strategic oversight and decision making duties over the Parties' activities hereunder and to provide a forum for regular exchange of data (to the extent required under this Agreement) relating to the Licensed Products.

        5.2     Make-up of the JSC:     The JSC will consist of six members, namely, three members from each of BIAL and SEPRACOR, at least one of whom from each Party will be an Executive Officer of such Party. Each Party will designate its initial members of the JSC within the period of [**] after the Effective Date. BIAL and SEPRACOR may each replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 16.11 of this Agreement. Any member of the JSC may designate a substitute with due authority to temporarily attend and perform the functions of that member at any meeting of the JSC as long as an Executive Officer from each Party will always be present. BIAL and SEPRACOR each may, in its sole discretion but subject to the written objection of the other Party (with demonstrable reason for objection), invite to attend meetings or portions of such meetings of the JSC a reasonable number of non-member representatives of such Party (including, without limitation, its employees or non-employee professional advisors), who have a reasonable purpose for attending such meeting or portion of such meeting. The chairperson of the JSC will alternate at each meeting between one of BIAL's Executive Officers and one of SEPRACOR's Executive Officers. The chairperson will establish the timing (at a mutually agreed upon time with the other Party) and agenda for all JSC meetings and will send notice of such meetings, including the agenda at least [**] prior to the meeting, to all JSC members provided, however, that either Party may request that specific items be included in the agenda provided that notice of such changes is provided to all JSC members at least [**] prior to the date of the meeting.

        5.3     JSC Responsibilities:     Responsibilities of the JSC include, without limitation, the following:

•         [**]

        5.4     Meetings:     The JSC may meet, convene or be polled in person or by video or telephone conference (wh